{"representative": "Several previous epidemiological studies have shown a relation between drinking water quality and death in cardiovascular disease whereas others have not found such a relationship. An intervention study was undertaken to evaluate the effect of water with added magnesium and natural mineral water on blood pressure.A group of 70 subjects with borderline hypertension was recruited and consumed 1) a water low in minerals, 2) magnesium enriched water or 3) natural mineral water, in a random, double blind fashion during four weeks.Among persons with an initial low excretion of magnesium or calcium in the urine, the urinary excretion of magnesium was increased in the groups consuming the two waters containing magnesium after 4 weeks. A significant decrease in blood pressure was found in the group consuming mineral water at 2 and 4 weeks.The results suggest that minerals taken in water are significant for the body burden and that an intake of mineral water among persons with a low urinary excretion of magnesium or calcium may decrease the blood pressure. Further studies should investigate the extent of mineral deficiency in different populations and the efficiency of different vehicles for supplying minerals, particularly magnesium and calcium. A relation between mortality from ischaemic heart disease (IHD) and drinking water characteristics was first shown in Japan in 1957  and reviIn a case-control study, an inverse relation was found between the amount of magnesium in drinking water and death from acute myocardial infarction and for females also between the amount of calcium and death . Diets rRegarding individual minerals, several studies have been reported where hypertensive subjects were treated orally with nutritional doses of magnesium . The resEpidemiological studies on cardiovascular disease suggest that drinking water is an important vehicle for the supply of minerals . This isThe present intervention study was undertaken to determine the effect of minerals in water on one of the major risk factors for cardiovascular disease \u2013 blood pressure. Subjects with slightly elevated blood pressure consumed water with different levels of minerals. Serum and urinary levels of minerals were measured as a marker of intervention and blood pressure was measured before and after the intervention.Female and male subjects, aged 45 \u2013 64 years (n = 70) were recruited by advertising in local newspapers. Inclusion criteria were living in an area with low magnesium content in the drinking water, systolic pressure 15 mm above normal values for their age, diastolic pressure above 90 mm Hg, and within 20% of ideal body weight. Exclusion criteria were hypertension target organ damage, chronic diseases , pregnancy, and taking oral contraceptives or regular intake of mineral supplements. Subjects with a diastolic pressure above 100 mm Hg were advised to consult a physician for treatment. A few persons decided not to seek a physician's advice and choose to participate anyway. The Ethical committee at the Medical faculty, University of Gothenburg, approved the study.Blood pressure was measured using standardized techniques before the intervention, at 2 weeks and at the end at 4 weeks. Two separate recordings were made (diastolic pressure as Korothoff phase 5) after 5 minutes of supine rest. The blood pressure is reported as the average of these recordings.idem). Magnesium and calcium levels in urine were expressed as the creatinine ratio.Blood samples were taken before and after the intervention to determine the serum concentration of magnesium, calcium, sodium, creatinine and potassium . Before and after the intervention period, 24 hours urine samples were collected and the amounts of magnesium, calcium, and creatinine were determined . Table Table In spite of the random allocation to the different waters, it was found that the group consuming water C comprised a larger number of persons with a high initial systolic pressure. In the groups receiving waters A and B, none of the subjects had systolic blood pressures above 170 before the intervention. The subjects drinking water C were divided into those with an initial systolic pressure above and below 170 mm. For the group with the higher pressure (n = 6), there was a decrease in the systolic pressure before and at 4 weeks p = 0.023) but no difference at 2 weeks or for diastolic pressure. The results from the remainder of the group are also shown in Table  but no dThe study is of exploratory character, based on a relatively small number of subjects and should be interpreted with care. There is also a lack of some data that retrospectively would have been of interest such as sodium in the urine and the effect of water with only calcium added. We do not think, however, that this has any influence on the major conclusions from the study.The intervention with the two waters with added magnesium influenced the body burden in terms of an increased excretion of magnesium in urine. This is consistent with findings from previous intervention studies ,17 althoThe intervention with water containing high amounts of several minerals decreased the blood pressure significantly in contrast to water with magnesium only where no significant effect was detected. This does not exclude that an effect could have been found with the latter water, had the intervention time been longer. On the other hand, the finding supports the concept that interventions should be performed under conditions similar to the ones present in normal environments, rather than with one specific agent. This could also explain the lack of an effect in previous studies where single minerals have been given as reviewed in the introduction.In summary, the results suggest that waterborne minerals constitute a supply for the body burden, that the urinary excretion can be used as a physiologically relevant indicator of the body burden of magnesium and calcium, and that the supplementation of magnesium together with other minerals may reduce blood pressure among persons with a low body burden of magnesium and calcium, either due to an insufficient intake through food or water, or through some metabolic/clinical disturbance. Additional studies are needed to explore this further.The study was supported by an unconditional grant to Gothenburg University from the Nestl\u00e9 Water Institute, Vittel, France. The authors had full freedom for data analysis, manuscript preparation and submittance to a journal. RR has not received any fees or salaries for this work, including article processing charges, nor does he own any shares or has any other financial interest in the company. MA was an employee at the Water Institute at the time of the study.RR and MA jointly developed the research plan. RR conducted the field study. RR and MA jointly analyzed the data and wrote the manuscript.The pre-publication history for this paper can be accessed here:", "texts": ["Several previous epidemiological studies have shown a relation between drinking water quality and death in cardiovascular disease whereas others have not found such a relationship. An intervention study was undertaken to evaluate the effect of water with added magnesium and natural mineral water on blood pressure.A group of 70 subjects with borderline hypertension was recruited and consumed 1) a water low in minerals, 2) magnesium enriched water or 3) natural mineral water, in a random, double blind fashion during four weeks.Among persons with an initial low excretion of magnesium or calcium in the urine, the urinary excretion of magnesium was increased in the groups consuming the two waters containing magnesium after 4 weeks. A significant decrease in blood pressure was found in the group consuming mineral water at 2 and 4 weeks.The results suggest that minerals taken in water are significant for the body burden and that an intake of mineral water among persons with a low urinary excretion of magnesium or calcium may decrease the blood pressure. Further studies should investigate the extent of mineral deficiency in different populations and the efficiency of different vehicles for supplying minerals, particularly magnesium and calcium. A relation between mortality from ischaemic heart disease (IHD) and drinking water characteristics was first shown in Japan in 1957  and reviIn a case-control study, an inverse relation was found between the amount of magnesium in drinking water and death from acute myocardial infarction and for females also between the amount of calcium and death . Diets rRegarding individual minerals, several studies have been reported where hypertensive subjects were treated orally with nutritional doses of magnesium . The resEpidemiological studies on cardiovascular disease suggest that drinking water is an important vehicle for the supply of minerals . This isThe present intervention study was undertaken to determine the effect of minerals in water on one of the major risk factors for cardiovascular disease \u2013 blood pressure. Subjects with slightly elevated blood pressure consumed water with different levels of minerals. Serum and urinary levels of minerals were measured as a marker of intervention and blood pressure was measured before and after the intervention.Female and male subjects, aged 45 \u2013 64 years (n = 70) were recruited by advertising in local newspapers. Inclusion criteria were living in an area with low magnesium content in the drinking water, systolic pressure 15 mm above normal values for their age, diastolic pressure above 90 mm Hg, and within 20% of ideal body weight. Exclusion criteria were hypertension target organ damage, chronic diseases , pregnancy, and taking oral contraceptives or regular intake of mineral supplements. Subjects with a diastolic pressure above 100 mm Hg were advised to consult a physician for treatment. A few persons decided not to seek a physician's advice and choose to participate anyway. The Ethical committee at the Medical faculty, University of Gothenburg, approved the study.Blood pressure was measured using standardized techniques before the intervention, at 2 weeks and at the end at 4 weeks. Two separate recordings were made (diastolic pressure as Korothoff phase 5) after 5 minutes of supine rest. The blood pressure is reported as the average of these recordings.idem). Magnesium and calcium levels in urine were expressed as the creatinine ratio.Blood samples were taken before and after the intervention to determine the serum concentration of magnesium, calcium, sodium, creatinine and potassium . Before and after the intervention period, 24 hours urine samples were collected and the amounts of magnesium, calcium, and creatinine were determined . Table Table In spite of the random allocation to the different waters, it was found that the group consuming water C comprised a larger number of persons with a high initial systolic pressure. In the groups receiving waters A and B, none of the subjects had systolic blood pressures above 170 before the intervention. The subjects drinking water C were divided into those with an initial systolic pressure above and below 170 mm. For the group with the higher pressure (n = 6), there was a decrease in the systolic pressure before and at 4 weeks p = 0.023) but no difference at 2 weeks or for diastolic pressure. The results from the remainder of the group are also shown in Table  but no dThe study is of exploratory character, based on a relatively small number of subjects and should be interpreted with care. There is also a lack of some data that retrospectively would have been of interest such as sodium in the urine and the effect of water with only calcium added. We do not think, however, that this has any influence on the major conclusions from the study.The intervention with the two waters with added magnesium influenced the body burden in terms of an increased excretion of magnesium in urine. This is consistent with findings from previous intervention studies ,17 althoThe intervention with water containing high amounts of several minerals decreased the blood pressure significantly in contrast to water with magnesium only where no significant effect was detected. This does not exclude that an effect could have been found with the latter water, had the intervention time been longer. On the other hand, the finding supports the concept that interventions should be performed under conditions similar to the ones present in normal environments, rather than with one specific agent. This could also explain the lack of an effect in previous studies where single minerals have been given as reviewed in the introduction.In summary, the results suggest that waterborne minerals constitute a supply for the body burden, that the urinary excretion can be used as a physiologically relevant indicator of the body burden of magnesium and calcium, and that the supplementation of magnesium together with other minerals may reduce blood pressure among persons with a low body burden of magnesium and calcium, either due to an insufficient intake through food or water, or through some metabolic/clinical disturbance. Additional studies are needed to explore this further.The study was supported by an unconditional grant to Gothenburg University from the Nestl\u00e9 Water Institute, Vittel, France. The authors had full freedom for data analysis, manuscript preparation and submittance to a journal. RR has not received any fees or salaries for this work, including article processing charges, nor does he own any shares or has any other financial interest in the company. MA was an employee at the Water Institute at the time of the study.RR and MA jointly developed the research plan. RR conducted the field study. RR and MA jointly analyzed the data and wrote the manuscript.The pre-publication history for this paper can be accessed here:"]}
{"representative": "This study was conceived to analyze how exercise and weight management psychosocial variables, derived from several health behavior change theories, predict weight change in a short-term intervention. The theories under analysis were the Social Cognitive Theory, the Transtheoretical Model, the Theory of Planned Behavior, and Self-Determination Theory.2; age = 38.3 \u00b1 5.8y), participating in a 16-week University-based weight control program. Body weight and a comprehensive psychometric battery were assessed at baseline and at program's end.Subjects were 142 overweight and obese women  but with great individual variability. Both exercise and weight management psychosocial variables improved during the intervention, with exercise-related variables showing the greatest effect sizes. Weight change was significantly predicted by each of the models under analysis, particularly those including self-efficacy. Bivariate and multivariate analyses results showed that change in variables related to weight management had a stronger predictive power than exercise-specific predictors and that change in weight management self-efficacy was the strongest individual correlate (p < .05). Among exercise predictors, with the exception of self-efficacy, importance/effort and intrinsic motivation towards exercise were the stronger predictors of weight reduction (p < .05).The present models were able to predict 20\u201330% of variance in short-term weight loss and changes in weight management self-efficacy accounted for a large share of the predictive power. As expected from previous studies, exercise variables were only moderately associated with short-term outcomes; they are expected to play a larger explanatory role in longer-term results. Obesity and excessive weight are common concerns among people in industrialized countries. Scientific literature consistently reports the epidemic status of obesity e.g., -3], howe, howe3]]Albeit reported inconsistently in the literature, psychosocial variables are accepted as playing a key role in explaining weight management ,5. TheseThe SCT is the most frequently used paradigm in weight management interventions  and it iimplementation intentions) are also part of the behavior change intervention  and exercise ,28], witstages of change (SOC), which reflect the temporal dimension of the behavior, divided in six consecutive stages; and ii) a set of constructs that explain how people evolve along the SOC. These are named processes of change, i.e. cognitive and behavioral activities that individuals use to modify their experiences and environments to obtain the desired behavior. Also included in this model are the decisional balance, representing the pros and cons of engaging in the behavior, and self-efficacy, reflecting the person's confidence in performing the health behavior change  and exer change , e.g., [r change ], mainlyr change . Studiesr change . Weight r change . This str change . Suris ar change . In thisThe SDT is a motivation theory that highlights people's inherent need to evolve and to be integrated in a social scenario. Three primary needs that have been identified are competence, relatedness, and autonomy, which lead to different types of motivation to act, the most important and desirable being intrinsic motivation. This construct reflects our inherent tendency to seek out novelty and challenge, while feeling competent and autonomous in the process. Enjoyment, mastery, and positive feelings arise from this quest, reinforcing the continuation of the behavior. In opposition, extrinsic motivation is more externally driven, more controlled , and more disconnected from the behavior itself (more focused on its outcomes). Lastly, amotivation is a state where there is a lack of intention to act so that the outcome behavior has no personal value and feelings of competence are not present . The SDTThe previous theories constitute science' best effort to explain how peoples' decisions and choices toward exercise and healthy nutrition are built . They arBuilding on recent discussions on the usefulness of theory-based interventions in health behavior promotion -40 and f2, and be free from major disease to be eligible for the study. After the selection process 142 overweight and obese women  started the program. For this study, only the first four months are being analyzed, a period during which all participants received the same intervention; they were later randomized to two different long-term programs or to controls. Attrition was 6.3% from baseline to 4 months (133 completers). However, some psychometric data were incomplete due to errors in the completion of some questionnaires either on baseline or after the intervention, leading to smaller sample sizes in some analyses.Participants were recruited from the community for a 2-year weight management program through newspaper ads, a website, email messages on listservs, and announcement flyers. Subjects were required to be older than 24 years, be premenopausal and not currently pregnant, have a BMI higher than 24.9 kg/mThe intervention was composed of fifteen weekly meetings, which lasted 120 minutes, and where both educational and practical components were scheduled. Attendance averaged 83% and groups were composed of 32\u201335 women, who entered the study in two cohorts. The intervention has been described before  and was In short, content included exercise, nutrition, and behavior modification components. Exercise topics ranged from the caloric expenditure of some common physical activities to choosing the right apparel to exercise. Exercise behavioral contents involved a motivational setup to increase walking and lifestyle physical activity, in which a pedometer was distributed and planning and log techniques were taught. Nutrition topics dealt, for example, with macronutrient and micronutrient content of the most common foods, energy density, and meal frequency. Behavioral nutrition contents comprised planning for special occasions, using the hunger scale, emotional eating, and preventing lapses, among others.These contents were expected to have effects on several constructs of the health behavior theories studied in the present investigation. For example the planning techniques should have an effect on intentions, on expected outcomes and in behavioral POC, while the more instructional activities should have interfered with attitudes, perceived barriers and in cognitive POC. In the beginning of each session participants were asked to share with the group their program-related experiences in the previous week. This discussion should have impacted on social support, social norms and self-efficacy, by vicarious learning and also by verbal and social persuasion from both staff and group members. Lastly, the intervention had the underlying goals of improving autonomy and that the participants should choose the tasks that were more enjoyable to them. These are highly motivational factors that have an effect on SDT constructs, accounting specifically for intrinsic motivation.The sessions were conducted by a team composed by two Ph.D.- and six M.S.-level exercise physiologists, psychologists, or dietitians. Participants were provided with individualized dietary plan and specific physical activity goals, aiming to induce an energy deficit of 300\u2013500 kcal/d, by comparison with baseline values. Participants were informed that weight loss should be understood as a long-term goal, and that 5% weight loss after six months was an appropriate goal.A large battery of psychometric instruments was used in this study and participants were requested to attend two sessions for their completion, in each evaluation period. The instruments were Portuguese validated versions of some of the most used instruments for the constructs under analysis. In this section and throughout the manuscript, variables were divided and are presented in two separate categories: \"weight management\" and \"exercise\".The SCT weight management-related variables included self-efficacy and outcome expectancy measures. The Weight Efficacy Lifestyle Questionnaire WEL \u2013 ,44] is a is a44]]The TTM weight management constructs were i) self-efficacy ,44, ii) The TPB weight management constructs were assessed by a set of 18 items ,48 measuSocial-cognitive theory exercise-related variables comprise self-efficacy, perceived barriers, and social support. Exercise self-efficacy was measured with the Self-Efficacy for Exercise Behaviors Scale SEEB \u2013 ,50], ass, ass50]]The TTM exercise related variables were self-efficacy ,50, SOC,The TPB exercise-related variables were assessed through 17 items ,56 measuWe used the Intrinsic Motivation Inventory IMI \u2013 ,58], to , to 58]]Weight was measured at baseline and four months. A standardized procedure was used where weight was measured twice, to the nearest 0.1 kg (average was used), using an electronic scale .For correlational analyses, all variables were expressed by the residuals of the 4-month variable value regressed on baseline data. This procedure is recommended by Cohen and Cohen  as it crThe impact of the intervention on weight and psychosocial variables was assessed by paired t-test procedures. Effect size' were calculated, and the criteria to designate its magnitude was the following: < .30 small effect size; .30 to .80 medium effect size; >.80 large effect size .The linear bivariate association between changes in weight and psychosocial variables were assessed by Pearson correlations. Multiple regression models were created to evaluate the multivariate estimates for the associations between psychosocial variables and weight change. The health behavior models' variables were entered separately in seven regression designs (three for the weight management related models and four for the exercise related models). The squared semi-part correlation was calculated to reflect the unique contribution of each predictor to the variance in the outcome variables .Weight change (WC) showed a large individual variability , contemplation (35.5%) and preparation (37.5%). After the 4-month intervention, these numbers were inverted, as participants were mostly in the action (58.6%) or maintenance (18.0%) stages. Further analysis of the exercise-related psychosocial variables , while maintenance was reached by 11.7% of the women. Weight management psychosocial variables did not change as markedly as exercise constructs and different variables emerged as significant, with intentions, subjective norms and outcome expectancies showing no change, while behavioral POC , self-efficacy , cognitive POC , attitude , and PBC  reflected the desired intervention changes.Pearson correlation was used to analyze associations between predictors and WC Table . The firTo look further at the predictive power of constructs from behavior change models on WC, we designed a set of multiple regressions, with separate models for the constructs within each theory Tables  and 4. T2 = 26.8%, p < .001), mostly due to changes in self-efficacy, which independently explained 19.4% of WC variance, seconded by behavioral POC with 3.1%. The SCT represented the next strongest model , with changes in self-efficacy alone contributing 20.5% to the explained variance. The model for TPB explained 17.6% (p < .001) of the variance in weight change, with attitude and PBC showing similar semi-part correlation values . All other weight management psychosocial constructs did not contribute significantly to the models.Weight management variables presented the stronger models, particularly the TTM , seconded by TTM . Change in self-efficacy was the only variable that significantly added predictive power to these models . The other models did not account significantly to weight change, although the importance/effort dimension in the SDT model independently contributed with 4.8% of the explained variance (p = .015).Table 2) scores; c) Theories that included self-efficacy (TTM and SCT) presented the stronger regression models, and d) Change in variables and models related to weight management had higher predictive power than those from exercise-related models.This study was conceived to analyze how changes in key psychosocial exercise- and weight management-related variables, derived from four important health behavior theories, would predict weight change during a behavioral obesity treatment short-term intervention. Weight change was significantly predicted by several single variables and by health behavior change theories/models as a whole. The following were this study's primary findings: a) Change in eating/weight management self-efficacy was the single best correlate of weight reduction, though several other variables were also associated with weight outcomes  ; b) About 20\u201330% of the variance in weight change was explained by the best prediction models and most showed statistically significant prediction  [The stronger models, TTM and SCT, were weight management-related and both included self-efficacy. We found few studies that have analyzed  losses) ,64. In t losses) . It coul losses)  reviewed losses) ,66. Inte losses) , raisingExercise processes seemed to be substantially influenced by the intervention, which included information on how to cope with common barriers, recommended exercises , scheduling techniques, physiologic and psychological benefits of exercise, and how to use/find available resources. Nevertheless, exercise-related variables and models were only moderately associated with weight outcomes with self-efficacy again showing the highest bivariate and multivariate associations. It is interesting to note that despite its association with weight loss, mean exercise self-efficacy scores did not change significantly during the intervention. As pointed out before , it is pSelf-Determination Theory was only evaluated regarding exercise constructs and represented a stronger model than the TPB, with the importance/effort dimension emerging as a single predictor from SDT. The intervention sessions repeatedly reinforced the importance of exercise for the success in weight management, especially for long-term outcomes, for instance by citing results from the National Weight Control Registry results . As a coLimitations of this investigation include self-reported data, the absence of a control group, a relatively small sample, and the lack of complete evaluation for some models , mostly due to the absence of validated Portuguese questionnaires for these constructs. Also, some of the constructs were analyzed with less than ideal measures, such as outcome expectancies. Finally, multiple measures collected during the 4-month program, instead of only pre and post results, would have improved our assessment of the psychosocial variables by better describing changes in each construct throughout the program.In sum, we observed that theories that comprise self-efficacy are the most predictive of weight change and that weight management- and eating-related constructs and theories better explain the variance in short-term outcomes, compared to exercise models. To a lesser extent, exercise theories were also predictive. However, their predictive power is expected to increase in longer-term analyses, especially for variables related to intrinsic motivation and SDT. This is in line with recent results in a very similar intervention, where psychosocial eating variables better predicted 4-months results while exercise motivation constructs were superior correlates of 16-month weight loss . In the The author(s) declare that they have no competing interests.ALP and PJT conceived the study and drafted the manuscript. ALP performed the statistical analysis, was responsible for psychometric assessments and participated in the study's implementation. TLB, SSM, CSM, and JTB actively participated in the study implementation and in data collection. SOS participated in the study design and in the selection of psychosocial predictors. LBS is a principal investigator in the research trial. All authors read and approved the final manuscript.", "texts": ["This study was conceived to analyze how exercise and weight management psychosocial variables, derived from several health behavior change theories, predict weight change in a short-term intervention. The theories under analysis were the Social Cognitive Theory, the Transtheoretical Model, the Theory of Planned Behavior, and Self-Determination Theory.2; age = 38.3 \u00b1 5.8y), participating in a 16-week University-based weight control program. Body weight and a comprehensive psychometric battery were assessed at baseline and at program's end.Subjects were 142 overweight and obese women  but with great individual variability. Both exercise and weight management psychosocial variables improved during the intervention, with exercise-related variables showing the greatest effect sizes. Weight change was significantly predicted by each of the models under analysis, particularly those including self-efficacy. Bivariate and multivariate analyses results showed that change in variables related to weight management had a stronger predictive power than exercise-specific predictors and that change in weight management self-efficacy was the strongest individual correlate (p < .05). Among exercise predictors, with the exception of self-efficacy, importance/effort and intrinsic motivation towards exercise were the stronger predictors of weight reduction (p < .05).The present models were able to predict 20\u201330% of variance in short-term weight loss and changes in weight management self-efficacy accounted for a large share of the predictive power. As expected from previous studies, exercise variables were only moderately associated with short-term outcomes; they are expected to play a larger explanatory role in longer-term results. Obesity and excessive weight are common concerns among people in industrialized countries. Scientific literature consistently reports the epidemic status of obesity e.g., -3], howe, howe3]]Albeit reported inconsistently in the literature, psychosocial variables are accepted as playing a key role in explaining weight management ,5. TheseThe SCT is the most frequently used paradigm in weight management interventions  and it iimplementation intentions) are also part of the behavior change intervention  and exercise ,28], witstages of change (SOC), which reflect the temporal dimension of the behavior, divided in six consecutive stages; and ii) a set of constructs that explain how people evolve along the SOC. These are named processes of change, i.e. cognitive and behavioral activities that individuals use to modify their experiences and environments to obtain the desired behavior. Also included in this model are the decisional balance, representing the pros and cons of engaging in the behavior, and self-efficacy, reflecting the person's confidence in performing the health behavior change  and exer change , e.g., [r change ], mainlyr change . Studiesr change . Weight r change . This str change . Suris ar change . In thisThe SDT is a motivation theory that highlights people's inherent need to evolve and to be integrated in a social scenario. Three primary needs that have been identified are competence, relatedness, and autonomy, which lead to different types of motivation to act, the most important and desirable being intrinsic motivation. This construct reflects our inherent tendency to seek out novelty and challenge, while feeling competent and autonomous in the process. Enjoyment, mastery, and positive feelings arise from this quest, reinforcing the continuation of the behavior. In opposition, extrinsic motivation is more externally driven, more controlled , and more disconnected from the behavior itself (more focused on its outcomes). Lastly, amotivation is a state where there is a lack of intention to act so that the outcome behavior has no personal value and feelings of competence are not present . The SDTThe previous theories constitute science' best effort to explain how peoples' decisions and choices toward exercise and healthy nutrition are built . They arBuilding on recent discussions on the usefulness of theory-based interventions in health behavior promotion -40 and f2, and be free from major disease to be eligible for the study. After the selection process 142 overweight and obese women  started the program. For this study, only the first four months are being analyzed, a period during which all participants received the same intervention; they were later randomized to two different long-term programs or to controls. Attrition was 6.3% from baseline to 4 months (133 completers). However, some psychometric data were incomplete due to errors in the completion of some questionnaires either on baseline or after the intervention, leading to smaller sample sizes in some analyses.Participants were recruited from the community for a 2-year weight management program through newspaper ads, a website, email messages on listservs, and announcement flyers. Subjects were required to be older than 24 years, be premenopausal and not currently pregnant, have a BMI higher than 24.9 kg/mThe intervention was composed of fifteen weekly meetings, which lasted 120 minutes, and where both educational and practical components were scheduled. Attendance averaged 83% and groups were composed of 32\u201335 women, who entered the study in two cohorts. The intervention has been described before  and was In short, content included exercise, nutrition, and behavior modification components. Exercise topics ranged from the caloric expenditure of some common physical activities to choosing the right apparel to exercise. Exercise behavioral contents involved a motivational setup to increase walking and lifestyle physical activity, in which a pedometer was distributed and planning and log techniques were taught. Nutrition topics dealt, for example, with macronutrient and micronutrient content of the most common foods, energy density, and meal frequency. Behavioral nutrition contents comprised planning for special occasions, using the hunger scale, emotional eating, and preventing lapses, among others.These contents were expected to have effects on several constructs of the health behavior theories studied in the present investigation. For example the planning techniques should have an effect on intentions, on expected outcomes and in behavioral POC, while the more instructional activities should have interfered with attitudes, perceived barriers and in cognitive POC. In the beginning of each session participants were asked to share with the group their program-related experiences in the previous week. This discussion should have impacted on social support, social norms and self-efficacy, by vicarious learning and also by verbal and social persuasion from both staff and group members. Lastly, the intervention had the underlying goals of improving autonomy and that the participants should choose the tasks that were more enjoyable to them. These are highly motivational factors that have an effect on SDT constructs, accounting specifically for intrinsic motivation.The sessions were conducted by a team composed by two Ph.D.- and six M.S.-level exercise physiologists, psychologists, or dietitians. Participants were provided with individualized dietary plan and specific physical activity goals, aiming to induce an energy deficit of 300\u2013500 kcal/d, by comparison with baseline values. Participants were informed that weight loss should be understood as a long-term goal, and that 5% weight loss after six months was an appropriate goal.A large battery of psychometric instruments was used in this study and participants were requested to attend two sessions for their completion, in each evaluation period. The instruments were Portuguese validated versions of some of the most used instruments for the constructs under analysis. In this section and throughout the manuscript, variables were divided and are presented in two separate categories: \"weight management\" and \"exercise\".The SCT weight management-related variables included self-efficacy and outcome expectancy measures. The Weight Efficacy Lifestyle Questionnaire WEL \u2013 ,44] is a is a44]]The TTM weight management constructs were i) self-efficacy ,44, ii) The TPB weight management constructs were assessed by a set of 18 items ,48 measuSocial-cognitive theory exercise-related variables comprise self-efficacy, perceived barriers, and social support. Exercise self-efficacy was measured with the Self-Efficacy for Exercise Behaviors Scale SEEB \u2013 ,50], ass, ass50]]The TTM exercise related variables were self-efficacy ,50, SOC,The TPB exercise-related variables were assessed through 17 items ,56 measuWe used the Intrinsic Motivation Inventory IMI \u2013 ,58], to , to 58]]Weight was measured at baseline and four months. A standardized procedure was used where weight was measured twice, to the nearest 0.1 kg (average was used), using an electronic scale .For correlational analyses, all variables were expressed by the residuals of the 4-month variable value regressed on baseline data. This procedure is recommended by Cohen and Cohen  as it crThe impact of the intervention on weight and psychosocial variables was assessed by paired t-test procedures. Effect size' were calculated, and the criteria to designate its magnitude was the following: < .30 small effect size; .30 to .80 medium effect size; >.80 large effect size .The linear bivariate association between changes in weight and psychosocial variables were assessed by Pearson correlations. Multiple regression models were created to evaluate the multivariate estimates for the associations between psychosocial variables and weight change. The health behavior models' variables were entered separately in seven regression designs (three for the weight management related models and four for the exercise related models). The squared semi-part correlation was calculated to reflect the unique contribution of each predictor to the variance in the outcome variables .Weight change (WC) showed a large individual variability , contemplation (35.5%) and preparation (37.5%). After the 4-month intervention, these numbers were inverted, as participants were mostly in the action (58.6%) or maintenance (18.0%) stages. Further analysis of the exercise-related psychosocial variables , while maintenance was reached by 11.7% of the women. Weight management psychosocial variables did not change as markedly as exercise constructs and different variables emerged as significant, with intentions, subjective norms and outcome expectancies showing no change, while behavioral POC , self-efficacy , cognitive POC , attitude , and PBC  reflected the desired intervention changes.Pearson correlation was used to analyze associations between predictors and WC Table . The firTo look further at the predictive power of constructs from behavior change models on WC, we designed a set of multiple regressions, with separate models for the constructs within each theory Tables  and 4. T2 = 26.8%, p < .001), mostly due to changes in self-efficacy, which independently explained 19.4% of WC variance, seconded by behavioral POC with 3.1%. The SCT represented the next strongest model , with changes in self-efficacy alone contributing 20.5% to the explained variance. The model for TPB explained 17.6% (p < .001) of the variance in weight change, with attitude and PBC showing similar semi-part correlation values . All other weight management psychosocial constructs did not contribute significantly to the models.Weight management variables presented the stronger models, particularly the TTM , seconded by TTM . Change in self-efficacy was the only variable that significantly added predictive power to these models . The other models did not account significantly to weight change, although the importance/effort dimension in the SDT model independently contributed with 4.8% of the explained variance (p = .015).Table 2) scores; c) Theories that included self-efficacy (TTM and SCT) presented the stronger regression models, and d) Change in variables and models related to weight management had higher predictive power than those from exercise-related models.This study was conceived to analyze how changes in key psychosocial exercise- and weight management-related variables, derived from four important health behavior theories, would predict weight change during a behavioral obesity treatment short-term intervention. Weight change was significantly predicted by several single variables and by health behavior change theories/models as a whole. The following were this study's primary findings: a) Change in eating/weight management self-efficacy was the single best correlate of weight reduction, though several other variables were also associated with weight outcomes  ; b) About 20\u201330% of the variance in weight change was explained by the best prediction models and most showed statistically significant prediction  [The stronger models, TTM and SCT, were weight management-related and both included self-efficacy. We found few studies that have analyzed  losses) ,64. In t losses) . It coul losses)  reviewed losses) ,66. Inte losses) , raisingExercise processes seemed to be substantially influenced by the intervention, which included information on how to cope with common barriers, recommended exercises , scheduling techniques, physiologic and psychological benefits of exercise, and how to use/find available resources. Nevertheless, exercise-related variables and models were only moderately associated with weight outcomes with self-efficacy again showing the highest bivariate and multivariate associations. It is interesting to note that despite its association with weight loss, mean exercise self-efficacy scores did not change significantly during the intervention. As pointed out before , it is pSelf-Determination Theory was only evaluated regarding exercise constructs and represented a stronger model than the TPB, with the importance/effort dimension emerging as a single predictor from SDT. The intervention sessions repeatedly reinforced the importance of exercise for the success in weight management, especially for long-term outcomes, for instance by citing results from the National Weight Control Registry results . As a coLimitations of this investigation include self-reported data, the absence of a control group, a relatively small sample, and the lack of complete evaluation for some models , mostly due to the absence of validated Portuguese questionnaires for these constructs. Also, some of the constructs were analyzed with less than ideal measures, such as outcome expectancies. Finally, multiple measures collected during the 4-month program, instead of only pre and post results, would have improved our assessment of the psychosocial variables by better describing changes in each construct throughout the program.In sum, we observed that theories that comprise self-efficacy are the most predictive of weight change and that weight management- and eating-related constructs and theories better explain the variance in short-term outcomes, compared to exercise models. To a lesser extent, exercise theories were also predictive. However, their predictive power is expected to increase in longer-term analyses, especially for variables related to intrinsic motivation and SDT. This is in line with recent results in a very similar intervention, where psychosocial eating variables better predicted 4-months results while exercise motivation constructs were superior correlates of 16-month weight loss . In the The author(s) declare that they have no competing interests.ALP and PJT conceived the study and drafted the manuscript. ALP performed the statistical analysis, was responsible for psychometric assessments and participated in the study's implementation. TLB, SSM, CSM, and JTB actively participated in the study implementation and in data collection. SOS participated in the study design and in the selection of psychosocial predictors. LBS is a principal investigator in the research trial. All authors read and approved the final manuscript."]}
{"representative": "The relationship between BMI and leptin has been studied extensively in the past, but previous reports in postmenopausal women have not been conducted under carefully controlled dietary conditions of weight maintenance using precise measures of body fat distribution. The aim of the present study was to examine the association between serum leptin concentration and adiposity as estimated by BMI and dual energy x-ray absorptiometry (DEXA) measures  in postmenopausal women.This study was conducted as a cross-sectional analysis within the control segment of a randomized, crossover trial in which postmenopausal women (n = 51) consumed 0 (control), 15 (one drink), and 30 (two drinks) g alcohol (ethanol)/d for 8 weeks as part of a controlled diet. BMIs were determined and DEXA scans were administered to the women during the 0 g alcohol treatment, and a blood sample was collected at baseline and week 8 of each study period for leptin analysis.2) had a 2-fold increase, and obese women (BMI > 30 kg/m2) had more than a 3-fold increase in serum leptin concentrations compared to normal weight (BMI \u226425 kg/m2) women. When the models for the different measures of adiposity were assessed by multiple R2, models which included percent body fat explained the highest proportion (approximately 80%) of the serum leptin variance.In multivariate analysis, women who were overweight (BMI > 25 to \u2264 30 kg/mUnder carefully controlled dietary conditions, we confirm that higher levels of adiposity were associated with higher concentrations of serum leptin. It appears that percent body fat in postmenopausal women may be the best adiposity-related predictor of serum leptin. Natural menopause, a normal aspect of aging, may influence risk of breast cancer , the leain vitro models, leptin acts as a growth factor and stimulates cellular proliferation, angiogenesis, motility, and invasion [In various invasion -20. Leptinvasion ,20 and cinvasion . Leptin invasion . In thisstudy periods; each study period was separated by two-five week washout periods. Total and regional adiposity measurements were assessed during the fourth week of the control treatment . DEXA  whole body scans were used for adiposity assessments; measures of BMI were taken on the same day.This study was part of a randomized, crossover, intervention trial of moderate alcohol supplementation in postmenopausal women (n = 51). Details of the study design and procedures have been published previously ,24. Brie(1) women \u2265 50 y of age, (2) postmenopausal , (3) not receiving hormone replacement therapy (HRT), (4) not taking prescription medications that might interfere with the study, (5) willing and able to consume the diet prepared or approved by the Center and no other foods or beverages, and (6) without personal or parental history of alcohol abuse. The subjects were evaluated by a physician and determined to be in good health with no signs or symptoms of any disease or endocrine disorders.Postmenopausal women were recruited by advertisement from the communities surrounding the Beltsville Human Nutrition Research Center, Beltsville, MD. The eligibility criteria were: This study was approved by the National Cancer Institute's Institutional Review Board and the Committee on Human Research of the Johns Hopkins University Bloomberg School of Hygiene and Public Health. All subjects were fully informed of the study requirements and were required to read and sign a consent form detailing the objectives, risks, and benefits of the study. The subjects were compensated for their participation.All meals were prepared at the Beltsville Human Nutrition Research Center from typical U.S. foods and served in a seven-day menu cycle. Each day's diet provided 15% energy as protein, 50% energy as carbohydrate, and 35% energy as fat, with a polyunsaturated/monounsaturated/saturated fat ratio of 0.6:1:1. Daily fiber intake was 10 g/1,000 kcal, and daily cholesterol intake was 150 mg/1,000 kcal. Diets provided 100% of the U.S. recommended dietary allowances for vitamins and minerals . The stuBody composition was determined by pencil beam dual energy x-ray absorptiometry . Subjects were placed in a supine position with arms and legs close to their body for a whole body scan following the manufacturer's recommended protocol. Whole body and regional lean mass (mass of bone and nonfat soft tissue) and fat mass were determined using the manufacturer's algorithm (software version 1.33).During the last week of the control treatment, blood samples for leptin analysis were collected from fasting (> 12 hours) subjects before breakfast (6:30 AM to 9:00 AM) on each of three non-consecutive days in each study period. An equal volume of serum from each day's blood draw was pooled for analysis. Serum was separated and aliquots were frozen at -70\u00b0C. The laboratory methods for the serum leptin measurements were described previously . BrieflySerum leptin concentrations were log transformed using the natural log. All estimates of means and the differences between means were made using the log transformed leptin values. In tables we report means and regression coefficients returned to the original (arithmetic) scale.2 calculated from measured weight and height) were determined. Mean serum leptin concentrations for BMI categories were estimated using linear regression models that included a series of indicator variables for three standard BMI categories . BMI categories were also modeled as ordinal variables with values 0, 1, and 2. Additional models estimated percent changes in serum leptin concentrations per one-unit change in BMI, one-percent change in total body fat (measured as percent body fat), and 1000 g change in central, peripheral, or lean mass modeled as continuous variables. All models included age (continuous), parity (continuous), race , age of menarche , and family history of breast cancer . One woman's breast cancer information was missing and she was excluded from models that included breast cancer history. Sensitivity models including her as having or not having a family history of breast cancer did not change analysis conclusions. In a second series of models (Model 2), we added BMI to Model 1 as a covariate The addition of alcohol group assignment order, study period, hysterectomy, duration of menses, years since last menses, nulliparity, and age at first birth (for those with children) did not improve the precision of the estimates and these terms were not included in the final models. There was no evidence of effect modification as assessed by likelihood ratio tests of model fit after the addition of cross-product terms to models that included main effects. Throughout the paper all P-values are two-sided nominal (unadjusted) P-values. P-values for BMI and DEXA measurements were determined using likelihood ratio tests comparing models with the BMI or DEXA term of interest to models without that term. Multiple R2 and F-tests were calculated from the linear regression models. Statistical analyses were performed using S-PLUS .Pearson and Spearman correlations between the different DEXA measurements and BMI (kg/m2 to 42.5 kg/m2 (median 26.9); and total body fat ranged from 7,942 g to 55,756 g , while trunk, leg, and arm fat were of progressively lesser magnitude. Descriptive statistics for serum leptin concentrations are also presented in Table Fifty-one women successfully completed the entire study and are included in the present analysis. The physical characteristics and reproductive history of the subjects at baseline are provided in Table P < 0.0001). Among obese subjects, serum leptin concentrations were more than three-fold those seen in the normal weight subjects.Table Table 2 was used to assess the strength of the linear associations of the overall models to leptin , all adjusted for the covariates, so that they can be compared. Looking at the multiple R2 values, we found the percent body fat model explains a largest proportion (more than 80%) of the variance associated with serum leptin concentrations, and thus appear to be very strongly associated with serum leptin concentrations. However, all of the R2 values in Table Our adiposity measures are on different scales and it is difficult for example, to compare changes of one percent in body fat versus one kg body fat versus one BMI unit, thus we also used multiple RIn addition to the previous studies which suffer from inadequate control of diet and energy balance (known confounders of leptin levels) -14, in pSince increased BMI  and centAlthough our study is limited by its cross-sectional design and modest sample size, the strengths of this study include a homogeneous study population  and measurement stability, which resulted from the use of a carefully controlled diet adjusted to maintain body weight. The DEXA scans employed are considered a reference method for body composition analysis . AlthougIn conclusion, our study demonstrated that serum leptin concentrations showed striking differences by adiposity levels. Increased exposure to leptin was observed for increased adiposity determined by BMI, percent body fat, central and peripheral fat as well as lean body mass. Although BMI and DEXA adiposity  are highly correlated in this cross-sectional study, it remains for further studies to confirm and refine our observations regarding: (i) percent body fat as the best adiposity-related predictor of serum leptin, and (ii) the independent value of central body fat in this prediction even after adjustment for BMI. Because of the well-known arguments for limitations in the use of BMI , such asThe author(s) declare that they have no competing interests.", "texts": ["The relationship between BMI and leptin has been studied extensively in the past, but previous reports in postmenopausal women have not been conducted under carefully controlled dietary conditions of weight maintenance using precise measures of body fat distribution. The aim of the present study was to examine the association between serum leptin concentration and adiposity as estimated by BMI and dual energy x-ray absorptiometry (DEXA) measures  in postmenopausal women.This study was conducted as a cross-sectional analysis within the control segment of a randomized, crossover trial in which postmenopausal women (n = 51) consumed 0 (control), 15 (one drink), and 30 (two drinks) g alcohol (ethanol)/d for 8 weeks as part of a controlled diet. BMIs were determined and DEXA scans were administered to the women during the 0 g alcohol treatment, and a blood sample was collected at baseline and week 8 of each study period for leptin analysis.2) had a 2-fold increase, and obese women (BMI > 30 kg/m2) had more than a 3-fold increase in serum leptin concentrations compared to normal weight (BMI \u226425 kg/m2) women. When the models for the different measures of adiposity were assessed by multiple R2, models which included percent body fat explained the highest proportion (approximately 80%) of the serum leptin variance.In multivariate analysis, women who were overweight (BMI > 25 to \u2264 30 kg/mUnder carefully controlled dietary conditions, we confirm that higher levels of adiposity were associated with higher concentrations of serum leptin. It appears that percent body fat in postmenopausal women may be the best adiposity-related predictor of serum leptin. Natural menopause, a normal aspect of aging, may influence risk of breast cancer , the leain vitro models, leptin acts as a growth factor and stimulates cellular proliferation, angiogenesis, motility, and invasion [In various invasion -20. Leptinvasion ,20 and cinvasion . Leptin invasion . In thisstudy periods; each study period was separated by two-five week washout periods. Total and regional adiposity measurements were assessed during the fourth week of the control treatment . DEXA  whole body scans were used for adiposity assessments; measures of BMI were taken on the same day.This study was part of a randomized, crossover, intervention trial of moderate alcohol supplementation in postmenopausal women (n = 51). Details of the study design and procedures have been published previously ,24. Brie(1) women \u2265 50 y of age, (2) postmenopausal , (3) not receiving hormone replacement therapy (HRT), (4) not taking prescription medications that might interfere with the study, (5) willing and able to consume the diet prepared or approved by the Center and no other foods or beverages, and (6) without personal or parental history of alcohol abuse. The subjects were evaluated by a physician and determined to be in good health with no signs or symptoms of any disease or endocrine disorders.Postmenopausal women were recruited by advertisement from the communities surrounding the Beltsville Human Nutrition Research Center, Beltsville, MD. The eligibility criteria were: This study was approved by the National Cancer Institute's Institutional Review Board and the Committee on Human Research of the Johns Hopkins University Bloomberg School of Hygiene and Public Health. All subjects were fully informed of the study requirements and were required to read and sign a consent form detailing the objectives, risks, and benefits of the study. The subjects were compensated for their participation.All meals were prepared at the Beltsville Human Nutrition Research Center from typical U.S. foods and served in a seven-day menu cycle. Each day's diet provided 15% energy as protein, 50% energy as carbohydrate, and 35% energy as fat, with a polyunsaturated/monounsaturated/saturated fat ratio of 0.6:1:1. Daily fiber intake was 10 g/1,000 kcal, and daily cholesterol intake was 150 mg/1,000 kcal. Diets provided 100% of the U.S. recommended dietary allowances for vitamins and minerals . The stuBody composition was determined by pencil beam dual energy x-ray absorptiometry . Subjects were placed in a supine position with arms and legs close to their body for a whole body scan following the manufacturer's recommended protocol. Whole body and regional lean mass (mass of bone and nonfat soft tissue) and fat mass were determined using the manufacturer's algorithm (software version 1.33).During the last week of the control treatment, blood samples for leptin analysis were collected from fasting (> 12 hours) subjects before breakfast (6:30 AM to 9:00 AM) on each of three non-consecutive days in each study period. An equal volume of serum from each day's blood draw was pooled for analysis. Serum was separated and aliquots were frozen at -70\u00b0C. The laboratory methods for the serum leptin measurements were described previously . BrieflySerum leptin concentrations were log transformed using the natural log. All estimates of means and the differences between means were made using the log transformed leptin values. In tables we report means and regression coefficients returned to the original (arithmetic) scale.2 calculated from measured weight and height) were determined. Mean serum leptin concentrations for BMI categories were estimated using linear regression models that included a series of indicator variables for three standard BMI categories . BMI categories were also modeled as ordinal variables with values 0, 1, and 2. Additional models estimated percent changes in serum leptin concentrations per one-unit change in BMI, one-percent change in total body fat (measured as percent body fat), and 1000 g change in central, peripheral, or lean mass modeled as continuous variables. All models included age (continuous), parity (continuous), race , age of menarche , and family history of breast cancer . One woman's breast cancer information was missing and she was excluded from models that included breast cancer history. Sensitivity models including her as having or not having a family history of breast cancer did not change analysis conclusions. In a second series of models (Model 2), we added BMI to Model 1 as a covariate The addition of alcohol group assignment order, study period, hysterectomy, duration of menses, years since last menses, nulliparity, and age at first birth (for those with children) did not improve the precision of the estimates and these terms were not included in the final models. There was no evidence of effect modification as assessed by likelihood ratio tests of model fit after the addition of cross-product terms to models that included main effects. Throughout the paper all P-values are two-sided nominal (unadjusted) P-values. P-values for BMI and DEXA measurements were determined using likelihood ratio tests comparing models with the BMI or DEXA term of interest to models without that term. Multiple R2 and F-tests were calculated from the linear regression models. Statistical analyses were performed using S-PLUS .Pearson and Spearman correlations between the different DEXA measurements and BMI (kg/m2 to 42.5 kg/m2 (median 26.9); and total body fat ranged from 7,942 g to 55,756 g , while trunk, leg, and arm fat were of progressively lesser magnitude. Descriptive statistics for serum leptin concentrations are also presented in Table Fifty-one women successfully completed the entire study and are included in the present analysis. The physical characteristics and reproductive history of the subjects at baseline are provided in Table P < 0.0001). Among obese subjects, serum leptin concentrations were more than three-fold those seen in the normal weight subjects.Table Table 2 was used to assess the strength of the linear associations of the overall models to leptin , all adjusted for the covariates, so that they can be compared. Looking at the multiple R2 values, we found the percent body fat model explains a largest proportion (more than 80%) of the variance associated with serum leptin concentrations, and thus appear to be very strongly associated with serum leptin concentrations. However, all of the R2 values in Table Our adiposity measures are on different scales and it is difficult for example, to compare changes of one percent in body fat versus one kg body fat versus one BMI unit, thus we also used multiple RIn addition to the previous studies which suffer from inadequate control of diet and energy balance (known confounders of leptin levels) -14, in pSince increased BMI  and centAlthough our study is limited by its cross-sectional design and modest sample size, the strengths of this study include a homogeneous study population  and measurement stability, which resulted from the use of a carefully controlled diet adjusted to maintain body weight. The DEXA scans employed are considered a reference method for body composition analysis . AlthougIn conclusion, our study demonstrated that serum leptin concentrations showed striking differences by adiposity levels. Increased exposure to leptin was observed for increased adiposity determined by BMI, percent body fat, central and peripheral fat as well as lean body mass. Although BMI and DEXA adiposity  are highly correlated in this cross-sectional study, it remains for further studies to confirm and refine our observations regarding: (i) percent body fat as the best adiposity-related predictor of serum leptin, and (ii) the independent value of central body fat in this prediction even after adjustment for BMI. Because of the well-known arguments for limitations in the use of BMI , such asThe author(s) declare that they have no competing interests."]}
{"representative": "African American women exhibit a higher mortality rate from breast cancer than do white women. African American women are more likely to gain weight at diagnosis, which may increase their risk of cancer recurrence and comorbidities. Physical activity has been shown to decrease body mass index and improve quality of life in cancer survivors. This study was designed to evaluate the feasibility and impact of a community-based exercise intervention in African American breast cancer survivors.A theory-based eight-week community intervention using pedometers with scheduling, goal setting, and self-assessment was tested in a convenience sample of African American breast cancer survivors (n = 24). Data were collected at three time points to examine changes in steps walked per day, body mass index, and other anthropometric measures, attitudes, and demographic variables.Statistically significant increases in steps walked per day and attitude toward exercise as well as significant decreases in body mass index, body weight, percentage of body fat, and waist, hip, and forearm circumferences, as well as blood pressure, were reported from baseline to immediate post-intervention. Positive changes were retained or improved further at three-month follow-up except for attitude toward exercise. Participant retention rate during eight-week intervention was 92%.Increasing walking for exercise, without making other changes, can improve body mass index, anthropometric measures, and attitudes, which are associated with improved quality of life and reduced risk of cancer recurrence. The high participant retention rate, along with significant study outcomes, demonstrate that among this sample of African American breast cancer survivors, participants were motivated to improve their exercise habits. African American women exhibit a higher rate of breast cancer mortality when compared with white women ,2. BeingUntil recently, women who have completed cancer therapy have been offered little to improve survival or decrease risk of new disease. Yet studies show that as a group, breast cancer survivors are interested in improving their health behaviors and quality of life ,7. Two rTo address weight gain in African American breast cancer survivors, we designed a theory-based cognitive-behavioral walking program to test its feasibility and impact on steps per day and BMI. The study was pilot tested among African American breast cancer survivors, using a community education model in an urban inner-city setting.We pilot tested an eight-week community-based walking program in a convenience sample of African American breast cancer survivors (n = 24) to investigate feasibility and impact on outcome measures over three time points: 1) baseline, 2) immediate post-intervention, and 3) three-month follow-up. African American women who 1) had been diagnosed with breast cancer, 2) had completed treatment at least three months before recruitment, 3) were mobile, and 4) were less than 70 years of age were eligible for the study.Using a broad, organized effort, participants were recruited from Massey Cancer Center clinics, outreach sites, contacts with local churches, community leaders, and breast cancer organizations including breast cancer support groups. A city council member, along with other breast cancer survivors, was also instrumental in communicating study information throughout the community. Flyers, television announcements, and personal communication were used during the three-month recruitment effort. We contacted approximately 230 potentially eligible women. Recruitment rate was approximately 10%. Reasons for nonparticipation included having cancer treatment within the prior three months, not being able to attend community meetings because of work or family commitments, or having comorbid conditions that decreased mobility.The theory-driven intervention was designed with the primary study goal of integrating walking into one's daily routine. The Health Belief Model was used as the theoretical framework for the intervention . This weStudy variables were assessed at three time points: baseline, immediate post-intervention, and at three-month follow-up. The study goal was the integration of walking into the participant's daily routine. The primary study outcomes were changes in number of steps and BMI. Steps per day were measured using a steps-only pedometer. Participants were instructed to wear the pedometer upon rising in the morning until bedtime and to record the number of steps walked. BMI was calculated from weight and height using a calibrated scale. Waist, hip, and upper arm circumferences were measured using a tape measure, and blood pressure was measured with a standard blood pressure cuff. Body-fat percentage was measured using Futrex, a portable near-infrared sensor system . All cliParticipant demographic information, cancer history, and attitudinal measures were assessed using standardized survey items from other study instruments. The instrument was pilot tested in a comparable age group of African American women. Attitudes toward exercise were measured using the Exercise Decisional Balance instrument , a 16-itt tests were used to determine differences in mean anthropometric and attitudinal measures between the three time points. In addition, based on frequency distribution of time since diagnosis, all study variables were tested among those diagnosed three years or less prior to start of the intervention (1999\u20132002) (n = 10) and those diagnosed earlier (1978\u20131998) (n = 12), using independent samples t tests.Data were entered into a database using SPSS statistical software . Descriptive statistics were determined for all study variables. Analysis of variance was performed to test for differences in measures collected at baseline, immediately after intervention, and at three-month follow-up. Paired Twenty-four women were enrolled in the intervention study. One participant dropped out because of scheduling conflicts. One experienced a cancer recurrence, resulting in 22 eligible women completing the intervention.Feasibility was determined by examining attendance at weekly sessions, study retention, and receptivity to pedometer use. Attendance at weekly sessions was excellent, with 70% of the participants attending seven or more intervention sessions. Study retention to the eight-week study was also excellent, with 22 of 24 women completing the intervention and immediate post-assessment. Participants had positive experiences using the pedometers and recording steps per day. Broken or lost pedometers were reported by approximately 25% of the study sample, and they were replaced to ensure continuous data collection. Additional data showed that 95% responded \"about right\" to a survey item asking whether number of study sessions were too many, too few, or about right.P < .001),\u00a0hip circumference (P = .009), forearm circumference (P < .001), systolic blood pressure (P = .002), diastolic blood pressure (P = .001), and attitude toward exercise (P = .005).Results of ANOVA analyses of repeated measures  showed statistically significant differences in steps per day . Other significant decreases included the following: BMI (P = .004), body weight (P = .005), percentage body fat (P = .003), and forearm circumference (P = .007). Increased positive perception of exercise was also reported (P = .03).P = .04), forearm circumference (P = .04), and diastolic blood pressure (P = .02). Thus, all anthropometric measures either stayed the same or showed further improvement by further reduction in measures from immediate post-intervention to three-month follow-up. Of all study variables, only attitude toward exercise significantly changed direction (P < .001), with women showing a more negative opinion of exercise by three-month follow-up compared with immediate post-intervention. There were no differences in mean study outcomes in the participants who did not attend three-month follow-up assessment sessions (n = 5) compared with participants who did attend and had measurements (n = 17).P = .02) when compared to earlier diagnosed women. The same effect was true at immediate post-intervention for both diastolic blood pressure (P = .02) and systolic blood pressure (P = .003). At three-month follow-up, recently diagnosed women were significantly more likely to have higher waist measures (P = .048), with trends toward larger hip (P = .06) and body fat (P = .05) measures than earlier diagnosed women.More recently diagnosed women tended to have higher body measures at all three time points, but only diastolic blood pressure was significantly higher at baseline (We found statistically significant changes in the main study outcomes of steps per day, BMI, and virtually all of the anthropometric changes measured in the study population after an eight-week intervention, with most results remaining at three-month follow-up. The breast cancer survivor participants were motivated and compliant with the intervention, which likely enhanced their success. Having had cancer and understanding their risk of recurrence may account for the strong motivation we found in this population, as suggested by the constructs of the Health Belief Model. It is also important to note that the sample participants all had more than a high school education, which may also have contributed to their success.Although we found only a few statistically significant differences in mean body measures in relationship to time since diagnosis, we may have detected more evidence of this pattern had we had a larger study sample. While not significant, the more recently diagnosed women had larger body measures and lower mean steps per day than earlier diagnosed women at both immediately post and at three-month follow-up.The goal of the study was to have women integrate walking into their daily routines on their own. They attended sessions for education, motivation, and self-assessment; walking did not take place during the study sessions. This was an important feature of the study design because research shows that compliance is likely to decline significantly after an intervention is completed . Thus, oThe mean change in body weight was modest but significantly less than baseline. This level of weight loss supports what similar interventions have reported . We wereWomen in the study improved their attitude toward exercise from baseline to post-intervention by reporting fewer barriers to exercise over the study period. This was not surprising given the focus of the intervention sessions on overcoming personal obstacles to exercise. However, the attitudinal improvement did not hold at three-month follow-up. Although steps per day did not significantly change at three-month follow-up, one might wonder if the decline in exercise attitude might eventually negatively influence exercise behavior after a longer time interval. Cancer stress scores did not change significantly over the course of the intervention. However, scores for this variable were not particularly high even at the start of the intervention. This could be related to the fact that only 18% of participants were diagnosed during the 12 months prior to the start of the study. Cancer stress may subside as time passes after a woman's diagnosis.\u00a0Had we studied a group of more recently diagnosed women, we may have found more evidence of cancer stress at baseline and potential for impact after the exercise intervention than we did the with this study population.and physical activity \u2014 are modified. Overall, the study objectives were realized, and the study provides interesting pilot data for testing a more comprehensive lifestyle intervention in a similar population. However, the sample does not constitute a representative sample, and the study findings may not be applicable to other breast cancer survivors.This study was limited by the study size and lack of control group. For a pilot study, however, the sample size was adequate to study feasibility and study outcomes. In addition, the study reflects the common limitations for relying on self-report data. Anthropometric variables were included in the study in addition to self-reported data to provide measured data for evaluating results. The intervention tested exercise only; thus, even more significant changes among this population are possible if both energy balance components \u2014 food intake Steps walked per day, BMI, body circumferences, blood pressure, and attitudinal variables all showed improved mean statistically significant changes in this population of African American breast cancer survivors after a theory-based cognitive-behavioral community intervention. The study showed strong feasibility measures in positive response to using pedometers, high participant retention, social support, and excellent compliance after eight weeks. Given data indicating obesity is associated with shorter breast cancer survival time, these study results may position breast cancer survivors to have both improved quality of life and reduced risk of cancer recurrence. Further study is needed to test a randomized comprehensive diet and exercise intervention in African American breast cancer survivors against controls in a longer, larger randomized trial with additional study variables.", "texts": ["African American women exhibit a higher mortality rate from breast cancer than do white women. African American women are more likely to gain weight at diagnosis, which may increase their risk of cancer recurrence and comorbidities. Physical activity has been shown to decrease body mass index and improve quality of life in cancer survivors. This study was designed to evaluate the feasibility and impact of a community-based exercise intervention in African American breast cancer survivors.A theory-based eight-week community intervention using pedometers with scheduling, goal setting, and self-assessment was tested in a convenience sample of African American breast cancer survivors (n = 24). Data were collected at three time points to examine changes in steps walked per day, body mass index, and other anthropometric measures, attitudes, and demographic variables.Statistically significant increases in steps walked per day and attitude toward exercise as well as significant decreases in body mass index, body weight, percentage of body fat, and waist, hip, and forearm circumferences, as well as blood pressure, were reported from baseline to immediate post-intervention. Positive changes were retained or improved further at three-month follow-up except for attitude toward exercise. Participant retention rate during eight-week intervention was 92%.Increasing walking for exercise, without making other changes, can improve body mass index, anthropometric measures, and attitudes, which are associated with improved quality of life and reduced risk of cancer recurrence. The high participant retention rate, along with significant study outcomes, demonstrate that among this sample of African American breast cancer survivors, participants were motivated to improve their exercise habits. African American women exhibit a higher rate of breast cancer mortality when compared with white women ,2. BeingUntil recently, women who have completed cancer therapy have been offered little to improve survival or decrease risk of new disease. Yet studies show that as a group, breast cancer survivors are interested in improving their health behaviors and quality of life ,7. Two rTo address weight gain in African American breast cancer survivors, we designed a theory-based cognitive-behavioral walking program to test its feasibility and impact on steps per day and BMI. The study was pilot tested among African American breast cancer survivors, using a community education model in an urban inner-city setting.We pilot tested an eight-week community-based walking program in a convenience sample of African American breast cancer survivors (n = 24) to investigate feasibility and impact on outcome measures over three time points: 1) baseline, 2) immediate post-intervention, and 3) three-month follow-up. African American women who 1) had been diagnosed with breast cancer, 2) had completed treatment at least three months before recruitment, 3) were mobile, and 4) were less than 70 years of age were eligible for the study.Using a broad, organized effort, participants were recruited from Massey Cancer Center clinics, outreach sites, contacts with local churches, community leaders, and breast cancer organizations including breast cancer support groups. A city council member, along with other breast cancer survivors, was also instrumental in communicating study information throughout the community. Flyers, television announcements, and personal communication were used during the three-month recruitment effort. We contacted approximately 230 potentially eligible women. Recruitment rate was approximately 10%. Reasons for nonparticipation included having cancer treatment within the prior three months, not being able to attend community meetings because of work or family commitments, or having comorbid conditions that decreased mobility.The theory-driven intervention was designed with the primary study goal of integrating walking into one's daily routine. The Health Belief Model was used as the theoretical framework for the intervention . This weStudy variables were assessed at three time points: baseline, immediate post-intervention, and at three-month follow-up. The study goal was the integration of walking into the participant's daily routine. The primary study outcomes were changes in number of steps and BMI. Steps per day were measured using a steps-only pedometer. Participants were instructed to wear the pedometer upon rising in the morning until bedtime and to record the number of steps walked. BMI was calculated from weight and height using a calibrated scale. Waist, hip, and upper arm circumferences were measured using a tape measure, and blood pressure was measured with a standard blood pressure cuff. Body-fat percentage was measured using Futrex, a portable near-infrared sensor system . All cliParticipant demographic information, cancer history, and attitudinal measures were assessed using standardized survey items from other study instruments. The instrument was pilot tested in a comparable age group of African American women. Attitudes toward exercise were measured using the Exercise Decisional Balance instrument , a 16-itt tests were used to determine differences in mean anthropometric and attitudinal measures between the three time points. In addition, based on frequency distribution of time since diagnosis, all study variables were tested among those diagnosed three years or less prior to start of the intervention (1999\u20132002) (n = 10) and those diagnosed earlier (1978\u20131998) (n = 12), using independent samples t tests.Data were entered into a database using SPSS statistical software . Descriptive statistics were determined for all study variables. Analysis of variance was performed to test for differences in measures collected at baseline, immediately after intervention, and at three-month follow-up. Paired Twenty-four women were enrolled in the intervention study. One participant dropped out because of scheduling conflicts. One experienced a cancer recurrence, resulting in 22 eligible women completing the intervention.Feasibility was determined by examining attendance at weekly sessions, study retention, and receptivity to pedometer use. Attendance at weekly sessions was excellent, with 70% of the participants attending seven or more intervention sessions. Study retention to the eight-week study was also excellent, with 22 of 24 women completing the intervention and immediate post-assessment. Participants had positive experiences using the pedometers and recording steps per day. Broken or lost pedometers were reported by approximately 25% of the study sample, and they were replaced to ensure continuous data collection. Additional data showed that 95% responded \"about right\" to a survey item asking whether number of study sessions were too many, too few, or about right.P < .001),\u00a0hip circumference (P = .009), forearm circumference (P < .001), systolic blood pressure (P = .002), diastolic blood pressure (P = .001), and attitude toward exercise (P = .005).Results of ANOVA analyses of repeated measures  showed statistically significant differences in steps per day . Other significant decreases included the following: BMI (P = .004), body weight (P = .005), percentage body fat (P = .003), and forearm circumference (P = .007). Increased positive perception of exercise was also reported (P = .03).P = .04), forearm circumference (P = .04), and diastolic blood pressure (P = .02). Thus, all anthropometric measures either stayed the same or showed further improvement by further reduction in measures from immediate post-intervention to three-month follow-up. Of all study variables, only attitude toward exercise significantly changed direction (P < .001), with women showing a more negative opinion of exercise by three-month follow-up compared with immediate post-intervention. There were no differences in mean study outcomes in the participants who did not attend three-month follow-up assessment sessions (n = 5) compared with participants who did attend and had measurements (n = 17).P = .02) when compared to earlier diagnosed women. The same effect was true at immediate post-intervention for both diastolic blood pressure (P = .02) and systolic blood pressure (P = .003). At three-month follow-up, recently diagnosed women were significantly more likely to have higher waist measures (P = .048), with trends toward larger hip (P = .06) and body fat (P = .05) measures than earlier diagnosed women.More recently diagnosed women tended to have higher body measures at all three time points, but only diastolic blood pressure was significantly higher at baseline (We found statistically significant changes in the main study outcomes of steps per day, BMI, and virtually all of the anthropometric changes measured in the study population after an eight-week intervention, with most results remaining at three-month follow-up. The breast cancer survivor participants were motivated and compliant with the intervention, which likely enhanced their success. Having had cancer and understanding their risk of recurrence may account for the strong motivation we found in this population, as suggested by the constructs of the Health Belief Model. It is also important to note that the sample participants all had more than a high school education, which may also have contributed to their success.Although we found only a few statistically significant differences in mean body measures in relationship to time since diagnosis, we may have detected more evidence of this pattern had we had a larger study sample. While not significant, the more recently diagnosed women had larger body measures and lower mean steps per day than earlier diagnosed women at both immediately post and at three-month follow-up.The goal of the study was to have women integrate walking into their daily routines on their own. They attended sessions for education, motivation, and self-assessment; walking did not take place during the study sessions. This was an important feature of the study design because research shows that compliance is likely to decline significantly after an intervention is completed . Thus, oThe mean change in body weight was modest but significantly less than baseline. This level of weight loss supports what similar interventions have reported . We wereWomen in the study improved their attitude toward exercise from baseline to post-intervention by reporting fewer barriers to exercise over the study period. This was not surprising given the focus of the intervention sessions on overcoming personal obstacles to exercise. However, the attitudinal improvement did not hold at three-month follow-up. Although steps per day did not significantly change at three-month follow-up, one might wonder if the decline in exercise attitude might eventually negatively influence exercise behavior after a longer time interval. Cancer stress scores did not change significantly over the course of the intervention. However, scores for this variable were not particularly high even at the start of the intervention. This could be related to the fact that only 18% of participants were diagnosed during the 12 months prior to the start of the study. Cancer stress may subside as time passes after a woman's diagnosis.\u00a0Had we studied a group of more recently diagnosed women, we may have found more evidence of cancer stress at baseline and potential for impact after the exercise intervention than we did the with this study population.and physical activity \u2014 are modified. Overall, the study objectives were realized, and the study provides interesting pilot data for testing a more comprehensive lifestyle intervention in a similar population. However, the sample does not constitute a representative sample, and the study findings may not be applicable to other breast cancer survivors.This study was limited by the study size and lack of control group. For a pilot study, however, the sample size was adequate to study feasibility and study outcomes. In addition, the study reflects the common limitations for relying on self-report data. Anthropometric variables were included in the study in addition to self-reported data to provide measured data for evaluating results. The intervention tested exercise only; thus, even more significant changes among this population are possible if both energy balance components \u2014 food intake Steps walked per day, BMI, body circumferences, blood pressure, and attitudinal variables all showed improved mean statistically significant changes in this population of African American breast cancer survivors after a theory-based cognitive-behavioral community intervention. The study showed strong feasibility measures in positive response to using pedometers, high participant retention, social support, and excellent compliance after eight weeks. Given data indicating obesity is associated with shorter breast cancer survival time, these study results may position breast cancer survivors to have both improved quality of life and reduced risk of cancer recurrence. Further study is needed to test a randomized comprehensive diet and exercise intervention in African American breast cancer survivors against controls in a longer, larger randomized trial with additional study variables."]}
{"representative": "Asthma and allergic diseases are becoming increasingly frequent in children in urban centres of Latin America although the prevalence of allergic disease is still low in rural areas. Understanding better why the prevalence of asthma is greater in urban migrant populations and the role of risk factors such as life style and environmental exposures, may be key to understand what is behind this trend.The Esmeraldas-SCAALA  study consists of cross-sectional and nested case-control studies of school children in rural and urban areas of Esmeraldas Province in Ecuador. The cross-sectional study will investigate risk factors for atopy and allergic disease in rural and migrant urban Afro-Ecuadorian school children and the nested case-control study will examine environmental, biologic and social risk factors for asthma among asthma cases and non-asthmatic controls from the cross-sectional study. Data will be collected through standardised questionnaires, skin prick testing to relevant aeroallergen extracts, stool examinations for parasites, blood sampling , anthropometric measurements for assessment of nutritional status, exercise testing for assessment of exercise-induced bronchospasm and dust sampling for measurement of household endotoxin and allergen levels.The information will be used to identify the factors associated with an increased risk of asthma and allergies in migrant and urbanizing populations, to improve the understanding of the causes of the increase in asthma prevalence and to identify potentially modifiable factors to inform the design of prevention programmes to reduce the risk of allergy in urban populations in Latin America. Large increases in the prevalence of asthma and allergic diseases have been reported in industrialized countries during the last twenty to thirty years ,2, althoAllergic diseases are caused by a complex interaction between host genetics and environmental exposures. Temporal trends in allergy prevalence in developed countries , and theRural residence is consistently identified as the strongest protective factor against asthma in epidemiological studies ,9 and isChanges in exposures to many different environmental and life style factors are likely to occur in populations that migrate from rural to urban areas, and studies of migrants to urban areas and comparisons of environmental exposures with the original rural and with more established urban populations should allow the effects of environmental exposures in early life (e.g. causing immune programming) on allergy risk to be distinguished from the effects of current exposures. Clarification of the dynamics behind the causation of allergy and asthma in urban migrant populations will further improve our understanding of what is behind the increase of frequency of these diseases with urbanization and westernization. The identification of modifiable risk factors could lead to new public health initiatives to reduce the burden of allergic disease among urbanizing populations.Latin American countries are undergoing a rapid process of population change that includes urbanization, migration, economic development and adoption of a \"modern\" lifestyle. Among the burgeoning urban populations of Ecuador and other Latin American countries, asthma and allergic diseases are perceived to be an increasingly important public health problem of children , althougThe study described here is part of the Programme \"Social Change, Asthma and Allergy in Latin America\" (SCAALA), a research programme being conducted in Ecuador and Brazil , funded by The Wellcome Trust as part of the programme of Major Awards to Centres of Excellence in Latin America. The SCAALA collaboration aims to clarify the social and biological mechanisms that mediate the effect of population and lifestyle changes on the frequency of atopic diseases. This paper deals with the methodological aspects of the study being conducted in Ecuador.The study in Ecuador aims to study changes in the prevalence and risk factors for asthma and allergy in populations that migrate from rural to urban areas and examine how such changes may relate to changes in the risk of atopic disease. The study will measure the frequency of symptoms of asthma, allergic rhinitis and atopic dermatitis in school children in urban and rural areas, and will collect detailed information on life style factors and environmental exposures that may affect the frequency of atopic diseases in the urban and rural environments. The study will investigate also changes in key immunologic factors (i.e. cytokines) and environmental exposures  that may be associated with altered asthma risk in the rural and urban study groups. On the other hand, the SCAALA study in Brazil aims to investigate the associations between the prevalence and incidence of allergic diseases, environmental exposures, particularly hygiene-related exposures, and immunological parameters in a cohort of children in the city of Salvador in the State of Bahia, and has been described elsewhere .Ecuador is among the poorest of South American countries, with an estimated per capita GDP of US$4,300 in 2005 and industrialization that is far less advanced compared to richer countries in the region, such as Chile  . In Ecua2 and has a population of approximately 429,000. The main economic activities are oil industry, tourism, timber extraction, and African palm oil. The principal city in the Province is Esmeraldas, with a population of 250,566 that is home to approximately 80% of the Ecuador's Afro-Ecuadorian population [The study is based in Ecuador's northern coastal province, Esmeraldas Province. The Province covers an area of 15,237 kmpulation . Esmeralpulation . Over thThe study will be conducted among school children attending rural schools in Afro-Ecuadorian communities in the District of Eloy Alfaro, in a tropical coastal area of Esmeraldas Province, and in marginal Afro-Ecuadorian 'barrios' in an urban centre, where migrants from the rural area  congregate.The study forms two parts: (i) a cross-sectional study of environmental factors associated with atopy and allergic symptoms in school-age children in the rural District of Eloy Alfaro in Esmeraldas Province and in 'barrios' of the city of Esmeraldas where rural migrants congregate; and (ii) a nested case-control study of environmental risk factors for asthma using asthma cases identified from the cross-sectional study in urban and rural school children and a random sample of non-asthmatic controls.A total of 4,000 school children, aged 7 to 15 years, living in the District of Eloy Alfaro and 2,500 children of the same age range, living in the city of Esmeraldas, will be assessed to estimate the frequency of atopy and allergic diseases, including asthma, rhinitis and eczema, and identify and compare risk factors associated with these outcomes in urban and rural study populations. School children in urban areas will be defined by place of birth, period of residence in urban area and at what age, and whether their parents are migrants  or not. The cross-sectional study will examine the relationship between atopy and allergic symptoms in urban and rural school children and the environmental factors that modify this relationship.Asthma cases  and non-asthmatic controls , respectively, will be identified from the results of an allergy symptom questionnaire performed in the cross-sectional study by the questions \u2013 \"Have you had wheezing or whistling in the chest in the last 12 months? \" and \"Have you ever had wheezing or whistling in the chest at any time in the past?\" Non-asthmatic controls will be randomly selected from all children in each of the urban and rural areas that respond negatively to the second question. Nested case-control studies in the urban and rural areas will identify risk factors associated with symptoms of recent wheeze using both quantitative and qualitative epidemiological methods, investigations of immunological function and measurements of allergens and endotoxin in the environment.Data are available for the prevalence of recent wheeze in urban and rural study areas, from pilot surveys of 245 and 536 school children, respectively. These surveys estimate the prevalence of recent wheeze to be greater in the urban area . The prevalence of atopy was similar in urban and rural school children . A sample of 4,000 children in the rural area and 2,500 children in the urban area will provide approximately 820 cases of atopy for the cross-sectional study, and 292 and 335 cases of asthma for the case-control study in the rural and urban areas, respectively. Two hundred asthma cases from each area will be recruited into case-control studies . The study will have a case-control ratio of 1:4 . With a study power of 80% and P < 0.05, the nested case-control studies combined  will be able to detect significant effects on asthma of common exposures  with OR<0.7 and rare exposures  with OR<0.5. Likewise, the individual case-control studies  with the same power and level of significance will be able to detect an effect of OR<0.6 for common exposures , and OR<0.4 for rare exposures (10%).Asthma, rhinitis and eczema will be defined according to the core allergy symptom questions of the International Study of Allergy and Asthma in Childhood (ISAAC) . Atopy wA. Cross-sectional study: The questionnaire has been modified from the ISAAC Phase II study questionnaire [ionnaire , and hasionnaire ,25). TheB. Case-control study: A questionnaire for a more detailed history of asthma, rhinitis and eczema symptoms, based on the ISAAC phase II supplementary questionnaires [onnaires , will beonnaires  and of rThe presence of exercise-induced bronchospasm (EIB) will be assessed in all children in the case-control as described previously ,26. Briez-scores for weight-for-age, weight-for-height and height-for-age will be calculated using the EPINUT program .Finger prick blood samples will be collected from all subjects in the cross-sectional study to estimate hemoglobin level using standard procedures. Anthropometric measurements will be performed using standardised methodology and will include weight (kg), height (cm) and triceps skin fold thickness (mm). Entamoeba histolytica (with ingested red cells) and Giardia intestinalis will be offered appropriate doses of tinidazole.Single stool samples will be collected from all children and examined using the modified Kato-Katz and formol-ether concentration methods . IntestiDermatophagoides pteronyssinus mite and the American cockroach, Periplaneta americana. Dust samples will be analyzed for endotoxin and fungal \u03b2-glucans  and allergens from D. pteronyssinus (Der p 1) and P. americana (Per a 1) .Dust samples will be collected from the homes of the children in the case-control study using a ~ 1200 W vacuum cleaner, weighed and stored as described previously . SurveysD. pteronyssinus, American cockroach, and Ascaris lumbricoides using the Pharmacia CAP system ; IgG antibodies specific for hepatitis A virus, Helicobacter pylori, herpes simplex virus, herpes zoster virus, Epstein-Barr virus, and Toxoplasma gondii using commercially available assays; and for whole blood cultures stimulated with mitogen and relevant allergens for the measurement of the regulatory cytokines, IFN-\u03b3, IL-13, and IL-10, as described elsewhere [Blood samples (7 mL) will be collected by venipuncture from participants in the case-control study and will be used for obtaining serum for the measurement of: polyclonal IgE ; IgE antlsewhere . A wholelsewhere .D. pteronyssinus/D. farinae mix, American cockroach, Alternaria tenuis, cat, dog, '9 Southern grass mix', and 'New stock fungi mix' .All children in the cross-sectional study will be tested for immediate hypersensitivity responses to relevant aeroallergens as described previously ,28. A poThe analysis will be designed to address five principal study questions: 1) What is the frequency of atopy and asthma in school children from the rural and urban study areas? 2) What environmental exposures are associated with atopy and asthma and how do these interact with area of residence  to affect the relationship between atopy and wheeze symptoms? 3) Do environmental exposures associated with wheeze differ between migrant and established urban populations and, if so, are they potentially modifiable through intervention programmes? 4) Are place of birth  and/or period of residence in rural and urban areas associated with risk of allergy? 5) How do complex inter-relationships between factors at different levels  interact to affect the risk of asthma in urban and rural populations? Statistical analysis will be conducted according to a conceptual framework that defines a proposed causal pathway and the complex analytic approach to be used has been described in detail in a companion paper . MethodsEthical approval for the study has been obtained from the Hospital Pedro Vicente Maldonado, Provincia de Pichincha, Ecuador. Written informed consent to participate in the study will be obtained from the parent of each child and signed minor assent will be obtained from each child. The parent or guardian of each child will be provided with a copy of all laboratory results and if, appropriate, treatment recommendations will be made by a trained clinician that will review each case.Atopic asthma and other allergic diseases are becoming increasingly important public health problems in Latin American cities and there is little published information on the causes of this disease epidemic. The SCAALA  research initiative includes two epidemiological studies being conducted in urbanizing populations  that are investigating the environmental causes of allergy in urban Latin America and the biological and social mechanisms that underlie these epidemiological trends. While the SCAALA-Salvador aims to investigate the associations between the prevalence of asthma and other allergic diseases  and potential risk factors that includes living conditions and early life and current exposures to infections , the SCAThe Esmeraldas-SCAALA study in Ecuador includes cross-sectional and nested case-control studies conducted in rural and urban contexts. The studies are investigating the impact of urban migration on asthma risk and the environmental exposures that are associated with an increased risk of asthma in populations that migrate from rural to urban areas. The study will focus on a single ethnic cultural group, Afro-Ecuadorians, that traditionally has lived in the remote rural North Eastern region of Esmeraldas Province, but that has migrated in significant numbers over the past 30 years to cities such as the provincial capital, Esmeraldas. The study of a single and easily identifiable group that presumably shares the same genetic 'stock' and that has migrated locally (within the same Province) should allow important environmental risk factors to be identified more easily and should not suffer from the biases that limit the interpretation of studies that have investigated populations that have migrated between countries. Specifically, the study, by investigating a migrant population, will distinguish between the effects of early life exposures (inducing immune programming) and current exposures in determining allergy risk.The knowledge generated from this study will help to define the size of the public health problem of allergy in Ecuador and may identify possible environmental exposures that could be considered for primary prevention public health strategies. The study in Brazil is a prospective study investigating the effects of early life exposures to environmental factors, and the potential effects of these on the immune system and the risk of allergy and has been described in detail in a separate paper .The causes of the allergy epidemic in Latin America are assumed to be multifactorial and an important strength of the SCAALA studies is the use of similar causal frameworks and the sharing of methodology and expertise in a wide range of scientific disciplines . The two studies are complementary and are likely to yield important information on the underlying causes of the allergy epidemic in urban Latin America.st century, and allergic diseases are likely to emerge as the most prevalent of chronic diseases of childhood in Latin America during this century. Latin America urbanization has its roots on the intense process of displacement of the poor rural population that move to the urban centres looking for work and other improvements in their life conditions. It is expected that the knowledge generated from the SCAALA studies will help identify public health interventions that may ameliorate the adverse effects of urbanization on the prevalence and severity of asthma and allergic diseases.In summary, the aim of the proposed programme is to investigate the biological and social mechanisms that underlie the epidemic of allergic diseases in urban Latin America. Urbanization and the health problems associated with this phenomenon probably represent the single most important challenge for health researchers working in developing countries in the 21ISAAC: International Study of Asthma and Allergies in ChildhoodSCAALA: Social Change, Asthma and Allergy in Latin AmericaThe author(s) declare that they have no competing interests.PJC and LCR had the original idea for the study. PJC designed the study and drafted the manuscript. MC, MV were involved in study design and co-ordination. NAN and LPC were responsible for the immunological methods. BG was responsible for the statistical analysis plan. LR, AR, AC, RS and MB were involved in study design. All authors helped draft the manuscript, and read and approved the final version of the manuscript.The pre-publication history for this paper can be accessed here:", "texts": ["Asthma and allergic diseases are becoming increasingly frequent in children in urban centres of Latin America although the prevalence of allergic disease is still low in rural areas. Understanding better why the prevalence of asthma is greater in urban migrant populations and the role of risk factors such as life style and environmental exposures, may be key to understand what is behind this trend.The Esmeraldas-SCAALA  study consists of cross-sectional and nested case-control studies of school children in rural and urban areas of Esmeraldas Province in Ecuador. The cross-sectional study will investigate risk factors for atopy and allergic disease in rural and migrant urban Afro-Ecuadorian school children and the nested case-control study will examine environmental, biologic and social risk factors for asthma among asthma cases and non-asthmatic controls from the cross-sectional study. Data will be collected through standardised questionnaires, skin prick testing to relevant aeroallergen extracts, stool examinations for parasites, blood sampling , anthropometric measurements for assessment of nutritional status, exercise testing for assessment of exercise-induced bronchospasm and dust sampling for measurement of household endotoxin and allergen levels.The information will be used to identify the factors associated with an increased risk of asthma and allergies in migrant and urbanizing populations, to improve the understanding of the causes of the increase in asthma prevalence and to identify potentially modifiable factors to inform the design of prevention programmes to reduce the risk of allergy in urban populations in Latin America. Large increases in the prevalence of asthma and allergic diseases have been reported in industrialized countries during the last twenty to thirty years ,2, althoAllergic diseases are caused by a complex interaction between host genetics and environmental exposures. Temporal trends in allergy prevalence in developed countries , and theRural residence is consistently identified as the strongest protective factor against asthma in epidemiological studies ,9 and isChanges in exposures to many different environmental and life style factors are likely to occur in populations that migrate from rural to urban areas, and studies of migrants to urban areas and comparisons of environmental exposures with the original rural and with more established urban populations should allow the effects of environmental exposures in early life (e.g. causing immune programming) on allergy risk to be distinguished from the effects of current exposures. Clarification of the dynamics behind the causation of allergy and asthma in urban migrant populations will further improve our understanding of what is behind the increase of frequency of these diseases with urbanization and westernization. The identification of modifiable risk factors could lead to new public health initiatives to reduce the burden of allergic disease among urbanizing populations.Latin American countries are undergoing a rapid process of population change that includes urbanization, migration, economic development and adoption of a \"modern\" lifestyle. Among the burgeoning urban populations of Ecuador and other Latin American countries, asthma and allergic diseases are perceived to be an increasingly important public health problem of children , althougThe study described here is part of the Programme \"Social Change, Asthma and Allergy in Latin America\" (SCAALA), a research programme being conducted in Ecuador and Brazil , funded by The Wellcome Trust as part of the programme of Major Awards to Centres of Excellence in Latin America. The SCAALA collaboration aims to clarify the social and biological mechanisms that mediate the effect of population and lifestyle changes on the frequency of atopic diseases. This paper deals with the methodological aspects of the study being conducted in Ecuador.The study in Ecuador aims to study changes in the prevalence and risk factors for asthma and allergy in populations that migrate from rural to urban areas and examine how such changes may relate to changes in the risk of atopic disease. The study will measure the frequency of symptoms of asthma, allergic rhinitis and atopic dermatitis in school children in urban and rural areas, and will collect detailed information on life style factors and environmental exposures that may affect the frequency of atopic diseases in the urban and rural environments. The study will investigate also changes in key immunologic factors (i.e. cytokines) and environmental exposures  that may be associated with altered asthma risk in the rural and urban study groups. On the other hand, the SCAALA study in Brazil aims to investigate the associations between the prevalence and incidence of allergic diseases, environmental exposures, particularly hygiene-related exposures, and immunological parameters in a cohort of children in the city of Salvador in the State of Bahia, and has been described elsewhere .Ecuador is among the poorest of South American countries, with an estimated per capita GDP of US$4,300 in 2005 and industrialization that is far less advanced compared to richer countries in the region, such as Chile  . In Ecua2 and has a population of approximately 429,000. The main economic activities are oil industry, tourism, timber extraction, and African palm oil. The principal city in the Province is Esmeraldas, with a population of 250,566 that is home to approximately 80% of the Ecuador's Afro-Ecuadorian population [The study is based in Ecuador's northern coastal province, Esmeraldas Province. The Province covers an area of 15,237 kmpulation . Esmeralpulation . Over thThe study will be conducted among school children attending rural schools in Afro-Ecuadorian communities in the District of Eloy Alfaro, in a tropical coastal area of Esmeraldas Province, and in marginal Afro-Ecuadorian 'barrios' in an urban centre, where migrants from the rural area  congregate.The study forms two parts: (i) a cross-sectional study of environmental factors associated with atopy and allergic symptoms in school-age children in the rural District of Eloy Alfaro in Esmeraldas Province and in 'barrios' of the city of Esmeraldas where rural migrants congregate; and (ii) a nested case-control study of environmental risk factors for asthma using asthma cases identified from the cross-sectional study in urban and rural school children and a random sample of non-asthmatic controls.A total of 4,000 school children, aged 7 to 15 years, living in the District of Eloy Alfaro and 2,500 children of the same age range, living in the city of Esmeraldas, will be assessed to estimate the frequency of atopy and allergic diseases, including asthma, rhinitis and eczema, and identify and compare risk factors associated with these outcomes in urban and rural study populations. School children in urban areas will be defined by place of birth, period of residence in urban area and at what age, and whether their parents are migrants  or not. The cross-sectional study will examine the relationship between atopy and allergic symptoms in urban and rural school children and the environmental factors that modify this relationship.Asthma cases  and non-asthmatic controls , respectively, will be identified from the results of an allergy symptom questionnaire performed in the cross-sectional study by the questions \u2013 \"Have you had wheezing or whistling in the chest in the last 12 months? \" and \"Have you ever had wheezing or whistling in the chest at any time in the past?\" Non-asthmatic controls will be randomly selected from all children in each of the urban and rural areas that respond negatively to the second question. Nested case-control studies in the urban and rural areas will identify risk factors associated with symptoms of recent wheeze using both quantitative and qualitative epidemiological methods, investigations of immunological function and measurements of allergens and endotoxin in the environment.Data are available for the prevalence of recent wheeze in urban and rural study areas, from pilot surveys of 245 and 536 school children, respectively. These surveys estimate the prevalence of recent wheeze to be greater in the urban area . The prevalence of atopy was similar in urban and rural school children . A sample of 4,000 children in the rural area and 2,500 children in the urban area will provide approximately 820 cases of atopy for the cross-sectional study, and 292 and 335 cases of asthma for the case-control study in the rural and urban areas, respectively. Two hundred asthma cases from each area will be recruited into case-control studies . The study will have a case-control ratio of 1:4 . With a study power of 80% and P < 0.05, the nested case-control studies combined  will be able to detect significant effects on asthma of common exposures  with OR<0.7 and rare exposures  with OR<0.5. Likewise, the individual case-control studies  with the same power and level of significance will be able to detect an effect of OR<0.6 for common exposures , and OR<0.4 for rare exposures (10%).Asthma, rhinitis and eczema will be defined according to the core allergy symptom questions of the International Study of Allergy and Asthma in Childhood (ISAAC) . Atopy wA. Cross-sectional study: The questionnaire has been modified from the ISAAC Phase II study questionnaire [ionnaire , and hasionnaire ,25). TheB. Case-control study: A questionnaire for a more detailed history of asthma, rhinitis and eczema symptoms, based on the ISAAC phase II supplementary questionnaires [onnaires , will beonnaires  and of rThe presence of exercise-induced bronchospasm (EIB) will be assessed in all children in the case-control as described previously ,26. Briez-scores for weight-for-age, weight-for-height and height-for-age will be calculated using the EPINUT program .Finger prick blood samples will be collected from all subjects in the cross-sectional study to estimate hemoglobin level using standard procedures. Anthropometric measurements will be performed using standardised methodology and will include weight (kg), height (cm) and triceps skin fold thickness (mm). Entamoeba histolytica (with ingested red cells) and Giardia intestinalis will be offered appropriate doses of tinidazole.Single stool samples will be collected from all children and examined using the modified Kato-Katz and formol-ether concentration methods . IntestiDermatophagoides pteronyssinus mite and the American cockroach, Periplaneta americana. Dust samples will be analyzed for endotoxin and fungal \u03b2-glucans  and allergens from D. pteronyssinus (Der p 1) and P. americana (Per a 1) .Dust samples will be collected from the homes of the children in the case-control study using a ~ 1200 W vacuum cleaner, weighed and stored as described previously . SurveysD. pteronyssinus, American cockroach, and Ascaris lumbricoides using the Pharmacia CAP system ; IgG antibodies specific for hepatitis A virus, Helicobacter pylori, herpes simplex virus, herpes zoster virus, Epstein-Barr virus, and Toxoplasma gondii using commercially available assays; and for whole blood cultures stimulated with mitogen and relevant allergens for the measurement of the regulatory cytokines, IFN-\u03b3, IL-13, and IL-10, as described elsewhere [Blood samples (7 mL) will be collected by venipuncture from participants in the case-control study and will be used for obtaining serum for the measurement of: polyclonal IgE ; IgE antlsewhere . A wholelsewhere .D. pteronyssinus/D. farinae mix, American cockroach, Alternaria tenuis, cat, dog, '9 Southern grass mix', and 'New stock fungi mix' .All children in the cross-sectional study will be tested for immediate hypersensitivity responses to relevant aeroallergens as described previously ,28. A poThe analysis will be designed to address five principal study questions: 1) What is the frequency of atopy and asthma in school children from the rural and urban study areas? 2) What environmental exposures are associated with atopy and asthma and how do these interact with area of residence  to affect the relationship between atopy and wheeze symptoms? 3) Do environmental exposures associated with wheeze differ between migrant and established urban populations and, if so, are they potentially modifiable through intervention programmes? 4) Are place of birth  and/or period of residence in rural and urban areas associated with risk of allergy? 5) How do complex inter-relationships between factors at different levels  interact to affect the risk of asthma in urban and rural populations? Statistical analysis will be conducted according to a conceptual framework that defines a proposed causal pathway and the complex analytic approach to be used has been described in detail in a companion paper . MethodsEthical approval for the study has been obtained from the Hospital Pedro Vicente Maldonado, Provincia de Pichincha, Ecuador. Written informed consent to participate in the study will be obtained from the parent of each child and signed minor assent will be obtained from each child. The parent or guardian of each child will be provided with a copy of all laboratory results and if, appropriate, treatment recommendations will be made by a trained clinician that will review each case.Atopic asthma and other allergic diseases are becoming increasingly important public health problems in Latin American cities and there is little published information on the causes of this disease epidemic. The SCAALA  research initiative includes two epidemiological studies being conducted in urbanizing populations  that are investigating the environmental causes of allergy in urban Latin America and the biological and social mechanisms that underlie these epidemiological trends. While the SCAALA-Salvador aims to investigate the associations between the prevalence of asthma and other allergic diseases  and potential risk factors that includes living conditions and early life and current exposures to infections , the SCAThe Esmeraldas-SCAALA study in Ecuador includes cross-sectional and nested case-control studies conducted in rural and urban contexts. The studies are investigating the impact of urban migration on asthma risk and the environmental exposures that are associated with an increased risk of asthma in populations that migrate from rural to urban areas. The study will focus on a single ethnic cultural group, Afro-Ecuadorians, that traditionally has lived in the remote rural North Eastern region of Esmeraldas Province, but that has migrated in significant numbers over the past 30 years to cities such as the provincial capital, Esmeraldas. The study of a single and easily identifiable group that presumably shares the same genetic 'stock' and that has migrated locally (within the same Province) should allow important environmental risk factors to be identified more easily and should not suffer from the biases that limit the interpretation of studies that have investigated populations that have migrated between countries. Specifically, the study, by investigating a migrant population, will distinguish between the effects of early life exposures (inducing immune programming) and current exposures in determining allergy risk.The knowledge generated from this study will help to define the size of the public health problem of allergy in Ecuador and may identify possible environmental exposures that could be considered for primary prevention public health strategies. The study in Brazil is a prospective study investigating the effects of early life exposures to environmental factors, and the potential effects of these on the immune system and the risk of allergy and has been described in detail in a separate paper .The causes of the allergy epidemic in Latin America are assumed to be multifactorial and an important strength of the SCAALA studies is the use of similar causal frameworks and the sharing of methodology and expertise in a wide range of scientific disciplines . The two studies are complementary and are likely to yield important information on the underlying causes of the allergy epidemic in urban Latin America.st century, and allergic diseases are likely to emerge as the most prevalent of chronic diseases of childhood in Latin America during this century. Latin America urbanization has its roots on the intense process of displacement of the poor rural population that move to the urban centres looking for work and other improvements in their life conditions. It is expected that the knowledge generated from the SCAALA studies will help identify public health interventions that may ameliorate the adverse effects of urbanization on the prevalence and severity of asthma and allergic diseases.In summary, the aim of the proposed programme is to investigate the biological and social mechanisms that underlie the epidemic of allergic diseases in urban Latin America. Urbanization and the health problems associated with this phenomenon probably represent the single most important challenge for health researchers working in developing countries in the 21ISAAC: International Study of Asthma and Allergies in ChildhoodSCAALA: Social Change, Asthma and Allergy in Latin AmericaThe author(s) declare that they have no competing interests.PJC and LCR had the original idea for the study. PJC designed the study and drafted the manuscript. MC, MV were involved in study design and co-ordination. NAN and LPC were responsible for the immunological methods. BG was responsible for the statistical analysis plan. LR, AR, AC, RS and MB were involved in study design. All authors helped draft the manuscript, and read and approved the final version of the manuscript.The pre-publication history for this paper can be accessed here:"]}
{"representative": "Evaluation of an Internet-based smoking cessation program: lessons learned from a pilot study [http://www.qsn.ori.org/), and the efforts to recruit participants and conduct a study through the Internet.It is estimated that more than 4 million people die annually from tobacco-related illnesses globally . Well-deot study  represenThe authors of this paper have considerable experience in medical computing and in the burgeoning area of behavioural eHealth, having published several recent papers on Internet-based interventions for diabetes -6. AlthoThe aim of the study is to evaluate a strategy for online study recruitment and retention, to evaluate the influence of incentives on follow-up response, and to assess the impact of the Quit Smoking Network site on smoking behaviour.Feil and colleagues  describea structured intervention that guides development of a cessation quit plan, interpersonal support , and a library of a wide variety of cessation resources .The intervention was also described as \"based on theoretically grounded and empirically validated intervention approaches\" citing an earlier paper by Lichenstein and Glasgow . DespiteThe research design is a single-condition study with a randomized follow-up component. Participants were recruited largely through magazine ads, local media coverage of the study and through the website itself . All participants were exposed to the website intervention and then randomly assigned to 1 of 4 follow-up conditions  afterwards. Participants completed a pretest survey online prior to the intervention and were contacted at 3 months postintervention to complete the follow-up online. Participants who did not complete the 3-month follow-up were randomly assigned to receive further follow-up notifications by email or regular US mail after 3 weeks. No description of the randomization process was provided.Two hundred and nine participants (56%) completed the 3-month follow-up, mostly through the Internet . Both the mode of communication  and incentive amount  provided similar rates of follow-up. With regard to the impact of the intervention, 38% (67) of participants reported abstinence  at 3-month follow-up . Such results are comparable to many other non-Internet smoking cessation trials .Although there was a reported cessation rate of 18% at 3 months, it is unclear whether this effect can be attributed to the intervention as no method of accounting for alternative explanations was provided. Since participants were self-selected based on an expressed interest in smoking cessation it seems reasonable that participants also sought other treatment options at the time of their participation. Another limitation of the study is the absence of the reported mean time to response after the second 3-month reminder was sent to participants.From a tobacco control perspective, there are additional concerns. An absence of a detailed description of instruments used to assess smoking variables is unfortunate. With a large body of literature in tobacco control, a number of acceptable measures or items have emerged to assess smoking behaviours and tobacco use. However no details of the items, item source, or scale reliability were provided and, in the case of cessation self-efficacy, were not even defined. Outside the effect on cigarette abstinence, the study's effects on outcome variables such as cessation self-efficacy were not reported.This study introduces a number of innovations for advancing knowledge of eHealth. The implementation and evaluation of an intervention completely at a distance represents a significant step forward in advancing eHealth research. Another innovation is the study of both incentive value and mode of contact on follow-up participation rates--issues that clearly require further study.Although the study design was innovative, the study as reported was problematic in a number of areas. With respect to eHealth issues, many of the evaluation reporting guidelines recommended by the Science Panel on Interactive Health Communication  were notDespite its limitations, many of which could have been reduced by more complete reporting, this is an important study for eHealth and tobacco control. As with many pioneering studies, this work offers more questions for eHealth research than answers; but the answers it does provide are nonetheless important. Furthermore, the findings of the study have great clinical significance for tobacco control given that the intervention was delivered in absentia and the potential for widespread, population-based translation of the intervention is high. Building on the results of this pilot test it is hoped that the authors will soon offer a more extensive evaluation of the Quit Smoking Network, one that has addressed some of the concerns stated here and that furthers this study's unique contribution to the literature.What method or process was used to randomize participants into each condition?Among those participants who did not respond to the initial follow-up request, what was the mean time to follow-up?What are the theoretical model(s) guiding the Quit Smoking Network site and how are they applied?How was intervention exposure (dose) assessed or measured for each participant?What other smoking strategies did participants report engaging in? If not measured, why?How was cessation self-efficacy measured?What were the levels of reported social support at baseline and how were such measures correlated with smoking cessation at 3-month follow-up?How do you propose researchers address the issue of validating smoking self-report using remotely-delivered interventions?", "texts": ["Evaluation of an Internet-based smoking cessation program: lessons learned from a pilot study [http://www.qsn.ori.org/), and the efforts to recruit participants and conduct a study through the Internet.It is estimated that more than 4 million people die annually from tobacco-related illnesses globally . Well-deot study  represenThe authors of this paper have considerable experience in medical computing and in the burgeoning area of behavioural eHealth, having published several recent papers on Internet-based interventions for diabetes -6. AlthoThe aim of the study is to evaluate a strategy for online study recruitment and retention, to evaluate the influence of incentives on follow-up response, and to assess the impact of the Quit Smoking Network site on smoking behaviour.Feil and colleagues  describea structured intervention that guides development of a cessation quit plan, interpersonal support , and a library of a wide variety of cessation resources .The intervention was also described as \"based on theoretically grounded and empirically validated intervention approaches\" citing an earlier paper by Lichenstein and Glasgow . DespiteThe research design is a single-condition study with a randomized follow-up component. Participants were recruited largely through magazine ads, local media coverage of the study and through the website itself . All participants were exposed to the website intervention and then randomly assigned to 1 of 4 follow-up conditions  afterwards. Participants completed a pretest survey online prior to the intervention and were contacted at 3 months postintervention to complete the follow-up online. Participants who did not complete the 3-month follow-up were randomly assigned to receive further follow-up notifications by email or regular US mail after 3 weeks. No description of the randomization process was provided.Two hundred and nine participants (56%) completed the 3-month follow-up, mostly through the Internet . Both the mode of communication  and incentive amount  provided similar rates of follow-up. With regard to the impact of the intervention, 38% (67) of participants reported abstinence  at 3-month follow-up . Such results are comparable to many other non-Internet smoking cessation trials .Although there was a reported cessation rate of 18% at 3 months, it is unclear whether this effect can be attributed to the intervention as no method of accounting for alternative explanations was provided. Since participants were self-selected based on an expressed interest in smoking cessation it seems reasonable that participants also sought other treatment options at the time of their participation. Another limitation of the study is the absence of the reported mean time to response after the second 3-month reminder was sent to participants.From a tobacco control perspective, there are additional concerns. An absence of a detailed description of instruments used to assess smoking variables is unfortunate. With a large body of literature in tobacco control, a number of acceptable measures or items have emerged to assess smoking behaviours and tobacco use. However no details of the items, item source, or scale reliability were provided and, in the case of cessation self-efficacy, were not even defined. Outside the effect on cigarette abstinence, the study's effects on outcome variables such as cessation self-efficacy were not reported.This study introduces a number of innovations for advancing knowledge of eHealth. The implementation and evaluation of an intervention completely at a distance represents a significant step forward in advancing eHealth research. Another innovation is the study of both incentive value and mode of contact on follow-up participation rates--issues that clearly require further study.Although the study design was innovative, the study as reported was problematic in a number of areas. With respect to eHealth issues, many of the evaluation reporting guidelines recommended by the Science Panel on Interactive Health Communication  were notDespite its limitations, many of which could have been reduced by more complete reporting, this is an important study for eHealth and tobacco control. As with many pioneering studies, this work offers more questions for eHealth research than answers; but the answers it does provide are nonetheless important. Furthermore, the findings of the study have great clinical significance for tobacco control given that the intervention was delivered in absentia and the potential for widespread, population-based translation of the intervention is high. Building on the results of this pilot test it is hoped that the authors will soon offer a more extensive evaluation of the Quit Smoking Network, one that has addressed some of the concerns stated here and that furthers this study's unique contribution to the literature.What method or process was used to randomize participants into each condition?Among those participants who did not respond to the initial follow-up request, what was the mean time to follow-up?What are the theoretical model(s) guiding the Quit Smoking Network site and how are they applied?How was intervention exposure (dose) assessed or measured for each participant?What other smoking strategies did participants report engaging in? If not measured, why?How was cessation self-efficacy measured?What were the levels of reported social support at baseline and how were such measures correlated with smoking cessation at 3-month follow-up?How do you propose researchers address the issue of validating smoking self-report using remotely-delivered interventions?"]}
{"representative": "RESPIRE, a randomized trial of an improved cookstove, was conducted in Guatemala to assess health effects of long-term reductions in wood smoke exposure. Given the evidence that ambient particles increase blood pressure, we hypothesized that the intervention would lower blood pressure.a) between-group comparisons based on randomized stove assignment, and b) before-and-after comparisons within subjects before and after they received improved stoves. From 2003 to 2005, we measured personal fine particle  exposures and systolic (SBP) and diastolic blood pressure (DBP) among women > 38 years of age from the chimney woodstove intervention group (49 subjects) and traditional open wood fire control group (71 subjects). Measures were repeated up to three occasions.Two study designs were used: 2.5 exposures were 264 and 102 \u03bcg/m3 in the control and intervention groups, respectively. After adjusting for age, body mass index, an asset index, smoking, secondhand tobacco smoke, apparent temperature, season, day of week, time of day, and a random subject intercept, the improved stove intervention was associated with 3.7 mm Hg lower SBP  and 3.0 mm Hg lower DBP  compared with controls. In the second study design, among 55 control subjects measured both before and after receiving chimney stoves, similar associations were observed.Daily average PMThe between-group comparisons provide evidence, particularly for DBP, that the chimney stove reduces blood pressure, and the before-and-after comparisons are consistent with this evidence. Approximately half of the world\u2019s households depend on biomass  and coal for cooking and heating . Most ofAlthough numerous epidemiologic investigations have concluded that fine ambient particles and secondhand tobacco smoke (SHS) are associated with cardiovascular morbidity and mortality , the WHO3 in homes where open fires were used for cooking  < 3.5 \u03bcm in aerodynamic diameter] were 1,930 \u03bcg/m cooking . Howeverxposures .plancha to conduct the first randomized intervention to reduce long-term air pollution exposures (We participated in RESPIRE (Randomized Exposure Study of Pollution Indoors and Respiratory Effects), which used the xposures . This trElevated blood pressure (BP) predicts cardiovascular morbidity and mortality, and reductions in BP have been shown to reduce risk , 2003. Splancha improved woodstove would be associated with long-term reductions in systolic blood pressure (SBP) and diastolic blood pressure (DBP) among healthy adults. As supporting evidence, we also aimed to determine whether the stove intervention was associated with reduced personal exposures to fine particulate air pollution.We hypothesized that the The protocols for the stove intervention trial were approved by the human subjects committees at the University of California-Berkeley, the U.S. Centers for Disease Control and Prevention, Liverpool University (UK), and the Universidad del Valle in Guatemala. The cardiovascular substudy was approved by the human subjects committees of the Harvard School of Public Health and Universidad del Valle, and all participants gave informed consent before data collection.San Marcos, Guatemala, borders the Pacific Ocean to the west and Chiapas, Mexico, to the north. From the rural area within this district, near the towns of San Lorenzo and Comitancillo, 23 villages were chosen based on a rapid assessment showing high prevalence (> 90%) of cooking with open wood fires. The study villages lie at 2,200\u20133,000 m elevation, creating a cool climate that necessitates enclosed homes, leading to high indoor air pollution concentrations.n = 537) were recruited and randomized from October 2002 through May 2003.Household eligibility criteria for the randomized trial, which focused on acute lower respiratory infections in infants, included exclusive use of an open biomass fire for cooking and having a pregnant woman or infant < 4 months of age. Households , among whom 208  were living and found at home during the substudy recruitment visit. The additional eligibility criteria, which were met by 185  of these women, were that they cooked daily and resided in a study house at the time of recruitment. Among the 185 eligible women invited to participate, the response rates were 75% among the control households and 54% among the intervention households, resulting in 120  participants overall. None of these women were pregnant, had given birth during the previous three months, nor were breast-feeding at the time of the study. Most were grandmothers of a child in the main study.2.5 (suspended PM < 2.5 \u03bcm in diameter) with gravimetric samplers during the 24 hr before blood pressure measurements. Each air sampler setup included an Apex pump , a Triplex Sharp-Cut Cyclone , and a 37-mm Teflon filter placed on top of a drain disc and inside a metal filter holder. The flow rate was set to 1.5 L/min and measured at the start and end of sampling with a soap bubble flow meter . The air sampler, weighing about 0.5 kg, was carried in a shoulder bag with the inlet clipped to the strap above waist height. The participants were instructed to carry the bags everywhere they went and place them near their bed when sleeping. The filters were weighed with a micro-balance  under atmosphere-controlled conditions before and after sampling.We measured average personal PMParticipants were transported in project vehicles from their homes to the San Lorenzo Health Center, where all BP measures were taken between 1400 and 1800 hr. An automatic blood pressure monitor  was used to measure SBP and DBP in the supported right arm of the seated subject after 10-min rest. Three repeat measures were taken within a 10-min period of continued rest.plancha for 293 days . After control households received the echo-intervention, an additional 65 measures were taken among 55 control subjects from March 2004 through March 2005. On average, the post\u2013echo-intervention measures were taken 63 days  after control households started using the improved stoves.Although 10 control subjects and 7 intervention subjects dropped out of the study or moved away from the study site after one measurement round, the protocol was repeated on two or three occasions for most participants. The trial period, from July 2003 through December 2005, included 111 measures among 71 women in the control group cooking over open fires and 115 measures among 49 women in the intervention group using the improved stoves. On average, the intervention participants had been cooking with the t-tests for continuous variables and chi-square tests for binary variables in SAS version 9.1 .We tested the baseline characteristics of the BP study intervention and control groups for comparability using We used the average of the second and third of three consecutive BP measures taken during each visit as the estimate for that day. SBP and DBP were the dependent variables in separate regression analyses. We estimated the intervention effects using two different study designs: between-group comparisons based on randomized stove assignment, and before-and-after echo-intervention comparisons among the control group.2.5 exposure and BP by study group, we plotted smoothed probability densities with spans determined by the default rule of thumb (nrd0) using R 2.4.0 software .The between-group study design compares BP between control and intervention groups during the trial period, when control homes had open fires for cooking and intervention homes had improved stoves. To illustrate the distributions of personal PMMixed models were run using the linear mixed effects (lme) function in R software. The model for the between-group estimates of the effect of improved stoves on BP isi denotes subject and j denotes the repeated measures within subjects. BMI is body mass index. \u03b2\u03021 is the effect estimate for the randomly assigned improved stove (Group), which has only the subscript i because it varies between people but not temporally. \u03b2\u03022, \u03b2\u03023, and so on represent the effects of covariates, the boi term is a random intercept for the ith subject, and \u025bij are the residuals. The random intercept accounts for correlation among repeated measures and therefore provides appropriate weighting of information from each subject, even though the number of measures per subject may vary.where temascal (wood-heated sauna), having household electricity, and an asset index as a measure of socioeconomic status. Age and BMI were fit as linear terms. We used binary indicator variables for smoking, SHS exposure, temascal use, and household electricity. The asset index is the sum of binary indicators for having a bicycle, a radio, and a television, and was entered as categorical variable. To increase precision, we also considered time-varying covariates, such as apparent temperature, season, day of the week, and time of day. We used linear terms to control for daily average apparent temperature and time of day and dummy variables for each day of the week and for rainy (1 May\u201331 October) versus dry season (1 November \u201330 April).Although randomization made the two groups similar according to all baseline covariates measured, because of the small sample size and potential for differential selection by intervention status and predictors of BP, we adjusted for covariates that may predict BP between subjects, such as age, BMI, ever smoking, SHS exposure, use of a 2.5 and BP among the control group during the trial and echo-intervention periods were illustrated using smoothed probability densities as described above. Only control subjects who had echo-intervention measures are included in these analyses, which were based on the following mixed model:The before-and-after study design estimates the within-subject effect of the stove intervention on BP by comparing the same people before and after adoption of the chimney stove. Distributions of personal PMPeriod), an indicator for the echo-intervention period, now also has a subscript j to denote that it varies across measurements within subjects. Temp refers to daily average apparent temperature. Again, a random intercept for subject is included.where the stove variable , \u22128.1 to 0.6] and 3.0 mm Hg lower DBP , both similar to the unadjusted associations. Excluding smokers did not alter the results, and there was no significant interaction between intervention and ever smoking nor intervention and SHS exposure for either BP measure .The crude and adjusted mixed-model estimates of between-group differences in mean SBP and DBP are shown in p < 0.001), and the association of SBP with the chimney stove in the between-group model increased in magnitude and precision to a reduction of 4.0 mm Hg . DBP did not have a significant nonlinear relationship with age (p = 0.62), and the estimate of the stove effect on DBP was unchanged by adjustment for age using the penalized spline model.Using penalized splines to adjust for age, we found a significant nonlinear relationship between SBP and age .The crude and adjusted mixed-model estimates of before-and-after differences in mean SBP and DBP are shown in In the before-and-after study design, adjustment for nonlinear associations between BP and age using penalized splines did not alter the associations of stove with either BP measure.plancha improved stove instead of the traditional open fire. After adjustment, the 95% CI for the mean difference in DBP did not overlap zero, and the 95% CI for the mean difference in SBP only barely overlapped zero. A few subjects from both groups were measured each week during the trial period, making any unmeasured time-varying covariates unlikely to be strong confounders. Adjustment for predictors of BP in the between-group model moved the effect estimates further away from the null. Similar estimates from the between-group and before-and-after analyses greatly strengthen the evidence because these are not susceptible to the same sources of bias. That participants and research assistants were not blinded to exposure status is unlikely to induce bias, because automatic blood pressure monitors were used. BP differences associated with stove type were estimated with greater precision in the before-and-after than in the between-group analyses, despite the larger sample size in the latter. This is attributed to lower random variability in BP within-subjects than in between-subjects.SBP and DBP were lower among women randomly assigned to cook with the 2.5 exposure associated with plancha compared with open fire use strengthens the evidence that the observed BP differences may have been caused by reduced wood smoke exposure. These personal exposures among both open fire and plancha users were much lower than average kitchen levels found in similar populations with the same stove types . If participation was also associated with BP, selection bias may have produced study groups that were not comparable. Although the original study design included baseline BP measures, ethical approval was given after the intervention group received improved stoves. Adjustment for age, socioeconomic indicators, and BMI is likely to have at least partially attenuated the potential selection bias. Furthermore, we did not find any meaningful difference between the groups out of all available baseline covariates. n = 23) were higher than the trial period BP among the 55 subjects measured both before and after . Thus, there is no evidence of spurious findings due to selection of subjects for the echo-intervention follow-up who happened to have higher blood pressure when measured during the trial period.The before-and-after comparisons rely on the assumption that BP would not have changed in the control group in the absence of the echo-intervention. There may be unmeasured time-varying covariates that influence BP and were associated with the echo-intervention. In addition, because not all control subjects measured during the trial period were also measured during the echo-intervention period, it is possible that we unintentionally selected people for the before-and-after comparisons who happened to have higher than usual BP before the echo-intervention. The trial period BP among the 16 control subjects excluded from the before-and-after comparisons due to missing post-echo-intervention measures  for cooking and heating , but woo", "texts": ["RESPIRE, a randomized trial of an improved cookstove, was conducted in Guatemala to assess health effects of long-term reductions in wood smoke exposure. Given the evidence that ambient particles increase blood pressure, we hypothesized that the intervention would lower blood pressure.a) between-group comparisons based on randomized stove assignment, and b) before-and-after comparisons within subjects before and after they received improved stoves. From 2003 to 2005, we measured personal fine particle  exposures and systolic (SBP) and diastolic blood pressure (DBP) among women > 38 years of age from the chimney woodstove intervention group (49 subjects) and traditional open wood fire control group (71 subjects). Measures were repeated up to three occasions.Two study designs were used: 2.5 exposures were 264 and 102 \u03bcg/m3 in the control and intervention groups, respectively. After adjusting for age, body mass index, an asset index, smoking, secondhand tobacco smoke, apparent temperature, season, day of week, time of day, and a random subject intercept, the improved stove intervention was associated with 3.7 mm Hg lower SBP  and 3.0 mm Hg lower DBP  compared with controls. In the second study design, among 55 control subjects measured both before and after receiving chimney stoves, similar associations were observed.Daily average PMThe between-group comparisons provide evidence, particularly for DBP, that the chimney stove reduces blood pressure, and the before-and-after comparisons are consistent with this evidence. Approximately half of the world\u2019s households depend on biomass  and coal for cooking and heating . Most ofAlthough numerous epidemiologic investigations have concluded that fine ambient particles and secondhand tobacco smoke (SHS) are associated with cardiovascular morbidity and mortality , the WHO3 in homes where open fires were used for cooking  < 3.5 \u03bcm in aerodynamic diameter] were 1,930 \u03bcg/m cooking . Howeverxposures .plancha to conduct the first randomized intervention to reduce long-term air pollution exposures (We participated in RESPIRE (Randomized Exposure Study of Pollution Indoors and Respiratory Effects), which used the xposures . This trElevated blood pressure (BP) predicts cardiovascular morbidity and mortality, and reductions in BP have been shown to reduce risk , 2003. Splancha improved woodstove would be associated with long-term reductions in systolic blood pressure (SBP) and diastolic blood pressure (DBP) among healthy adults. As supporting evidence, we also aimed to determine whether the stove intervention was associated with reduced personal exposures to fine particulate air pollution.We hypothesized that the The protocols for the stove intervention trial were approved by the human subjects committees at the University of California-Berkeley, the U.S. Centers for Disease Control and Prevention, Liverpool University (UK), and the Universidad del Valle in Guatemala. The cardiovascular substudy was approved by the human subjects committees of the Harvard School of Public Health and Universidad del Valle, and all participants gave informed consent before data collection.San Marcos, Guatemala, borders the Pacific Ocean to the west and Chiapas, Mexico, to the north. From the rural area within this district, near the towns of San Lorenzo and Comitancillo, 23 villages were chosen based on a rapid assessment showing high prevalence (> 90%) of cooking with open wood fires. The study villages lie at 2,200\u20133,000 m elevation, creating a cool climate that necessitates enclosed homes, leading to high indoor air pollution concentrations.n = 537) were recruited and randomized from October 2002 through May 2003.Household eligibility criteria for the randomized trial, which focused on acute lower respiratory infections in infants, included exclusive use of an open biomass fire for cooking and having a pregnant woman or infant < 4 months of age. Households , among whom 208  were living and found at home during the substudy recruitment visit. The additional eligibility criteria, which were met by 185  of these women, were that they cooked daily and resided in a study house at the time of recruitment. Among the 185 eligible women invited to participate, the response rates were 75% among the control households and 54% among the intervention households, resulting in 120  participants overall. None of these women were pregnant, had given birth during the previous three months, nor were breast-feeding at the time of the study. Most were grandmothers of a child in the main study.2.5 (suspended PM < 2.5 \u03bcm in diameter) with gravimetric samplers during the 24 hr before blood pressure measurements. Each air sampler setup included an Apex pump , a Triplex Sharp-Cut Cyclone , and a 37-mm Teflon filter placed on top of a drain disc and inside a metal filter holder. The flow rate was set to 1.5 L/min and measured at the start and end of sampling with a soap bubble flow meter . The air sampler, weighing about 0.5 kg, was carried in a shoulder bag with the inlet clipped to the strap above waist height. The participants were instructed to carry the bags everywhere they went and place them near their bed when sleeping. The filters were weighed with a micro-balance  under atmosphere-controlled conditions before and after sampling.We measured average personal PMParticipants were transported in project vehicles from their homes to the San Lorenzo Health Center, where all BP measures were taken between 1400 and 1800 hr. An automatic blood pressure monitor  was used to measure SBP and DBP in the supported right arm of the seated subject after 10-min rest. Three repeat measures were taken within a 10-min period of continued rest.plancha for 293 days . After control households received the echo-intervention, an additional 65 measures were taken among 55 control subjects from March 2004 through March 2005. On average, the post\u2013echo-intervention measures were taken 63 days  after control households started using the improved stoves.Although 10 control subjects and 7 intervention subjects dropped out of the study or moved away from the study site after one measurement round, the protocol was repeated on two or three occasions for most participants. The trial period, from July 2003 through December 2005, included 111 measures among 71 women in the control group cooking over open fires and 115 measures among 49 women in the intervention group using the improved stoves. On average, the intervention participants had been cooking with the t-tests for continuous variables and chi-square tests for binary variables in SAS version 9.1 .We tested the baseline characteristics of the BP study intervention and control groups for comparability using We used the average of the second and third of three consecutive BP measures taken during each visit as the estimate for that day. SBP and DBP were the dependent variables in separate regression analyses. We estimated the intervention effects using two different study designs: between-group comparisons based on randomized stove assignment, and before-and-after echo-intervention comparisons among the control group.2.5 exposure and BP by study group, we plotted smoothed probability densities with spans determined by the default rule of thumb (nrd0) using R 2.4.0 software .The between-group study design compares BP between control and intervention groups during the trial period, when control homes had open fires for cooking and intervention homes had improved stoves. To illustrate the distributions of personal PMMixed models were run using the linear mixed effects (lme) function in R software. The model for the between-group estimates of the effect of improved stoves on BP isi denotes subject and j denotes the repeated measures within subjects. BMI is body mass index. \u03b2\u03021 is the effect estimate for the randomly assigned improved stove (Group), which has only the subscript i because it varies between people but not temporally. \u03b2\u03022, \u03b2\u03023, and so on represent the effects of covariates, the boi term is a random intercept for the ith subject, and \u025bij are the residuals. The random intercept accounts for correlation among repeated measures and therefore provides appropriate weighting of information from each subject, even though the number of measures per subject may vary.where temascal (wood-heated sauna), having household electricity, and an asset index as a measure of socioeconomic status. Age and BMI were fit as linear terms. We used binary indicator variables for smoking, SHS exposure, temascal use, and household electricity. The asset index is the sum of binary indicators for having a bicycle, a radio, and a television, and was entered as categorical variable. To increase precision, we also considered time-varying covariates, such as apparent temperature, season, day of the week, and time of day. We used linear terms to control for daily average apparent temperature and time of day and dummy variables for each day of the week and for rainy (1 May\u201331 October) versus dry season (1 November \u201330 April).Although randomization made the two groups similar according to all baseline covariates measured, because of the small sample size and potential for differential selection by intervention status and predictors of BP, we adjusted for covariates that may predict BP between subjects, such as age, BMI, ever smoking, SHS exposure, use of a 2.5 and BP among the control group during the trial and echo-intervention periods were illustrated using smoothed probability densities as described above. Only control subjects who had echo-intervention measures are included in these analyses, which were based on the following mixed model:The before-and-after study design estimates the within-subject effect of the stove intervention on BP by comparing the same people before and after adoption of the chimney stove. Distributions of personal PMPeriod), an indicator for the echo-intervention period, now also has a subscript j to denote that it varies across measurements within subjects. Temp refers to daily average apparent temperature. Again, a random intercept for subject is included.where the stove variable , \u22128.1 to 0.6] and 3.0 mm Hg lower DBP , both similar to the unadjusted associations. Excluding smokers did not alter the results, and there was no significant interaction between intervention and ever smoking nor intervention and SHS exposure for either BP measure .The crude and adjusted mixed-model estimates of between-group differences in mean SBP and DBP are shown in p < 0.001), and the association of SBP with the chimney stove in the between-group model increased in magnitude and precision to a reduction of 4.0 mm Hg . DBP did not have a significant nonlinear relationship with age (p = 0.62), and the estimate of the stove effect on DBP was unchanged by adjustment for age using the penalized spline model.Using penalized splines to adjust for age, we found a significant nonlinear relationship between SBP and age .The crude and adjusted mixed-model estimates of before-and-after differences in mean SBP and DBP are shown in In the before-and-after study design, adjustment for nonlinear associations between BP and age using penalized splines did not alter the associations of stove with either BP measure.plancha improved stove instead of the traditional open fire. After adjustment, the 95% CI for the mean difference in DBP did not overlap zero, and the 95% CI for the mean difference in SBP only barely overlapped zero. A few subjects from both groups were measured each week during the trial period, making any unmeasured time-varying covariates unlikely to be strong confounders. Adjustment for predictors of BP in the between-group model moved the effect estimates further away from the null. Similar estimates from the between-group and before-and-after analyses greatly strengthen the evidence because these are not susceptible to the same sources of bias. That participants and research assistants were not blinded to exposure status is unlikely to induce bias, because automatic blood pressure monitors were used. BP differences associated with stove type were estimated with greater precision in the before-and-after than in the between-group analyses, despite the larger sample size in the latter. This is attributed to lower random variability in BP within-subjects than in between-subjects.SBP and DBP were lower among women randomly assigned to cook with the 2.5 exposure associated with plancha compared with open fire use strengthens the evidence that the observed BP differences may have been caused by reduced wood smoke exposure. These personal exposures among both open fire and plancha users were much lower than average kitchen levels found in similar populations with the same stove types . If participation was also associated with BP, selection bias may have produced study groups that were not comparable. Although the original study design included baseline BP measures, ethical approval was given after the intervention group received improved stoves. Adjustment for age, socioeconomic indicators, and BMI is likely to have at least partially attenuated the potential selection bias. Furthermore, we did not find any meaningful difference between the groups out of all available baseline covariates. n = 23) were higher than the trial period BP among the 55 subjects measured both before and after . Thus, there is no evidence of spurious findings due to selection of subjects for the echo-intervention follow-up who happened to have higher blood pressure when measured during the trial period.The before-and-after comparisons rely on the assumption that BP would not have changed in the control group in the absence of the echo-intervention. There may be unmeasured time-varying covariates that influence BP and were associated with the echo-intervention. In addition, because not all control subjects measured during the trial period were also measured during the echo-intervention period, it is possible that we unintentionally selected people for the before-and-after comparisons who happened to have higher than usual BP before the echo-intervention. The trial period BP among the 16 control subjects excluded from the before-and-after comparisons due to missing post-echo-intervention measures  for cooking and heating , but woo"]}
{"representative": "Whether lower frequency, moderate intensity exercise alters cardiovascular disease (CVD) risk has received little attention. This study examined the effects of 45 minutes self-paced walking, 2 d\u00b7 wk37 subjects (24 women) aged 41.5 \u00b1 9.3 years were randomly assigned to either two 45 minute walks per week  or no training (control group). Aerobic fitness, body composition, blood pressure (BP), CRP and lipoprotein variables were measured at baseline and following 8 weeks. Steps counts were measured at baseline and during weeks 4 and 8 of the intervention.P < 0.05). There were no changes other risk factors. Subjects took significantly more steps on the days when prescribed walking was performed (9303 \u00b1 2665) compared to rest days .Compared to the control group, the walking group showed a significant reduction in systolic BP and maintained body fat levels (max, improves activity levels, reduces systolic BP and prevents an increase in body fat in previously sedentary adults. This walking prescription, however, failed to induce significant improvements in other markers of cardiovascular disease risk following eight weeks of training.These findings suggest that walking twice per week for 45 minutes at ~ 62% HR It has become increasingly clear that many of the chronic diseases we face today are associated fundamentally with the pervasive sedentariness of modern lifestyle. In Northern Ireland at least 2000 people die each year due to an inactive lifestyle and the avoidable cost of inactivity to the health service is estimated at \u00a30.62 million each year . DespiteIn the past decade, physical activity research has been characterised by the development of exercise prescriptions that are palatable to sedentary populations in the western world. First advocated by the American College of Sports Medicine  and subs-1 for six months, improved fitness in 79\u201391 year old females [Walking is eminently suited to population exercise prescription as it is easy to do, requires no special skills or facilities, and is achievable by virtually all age groups with little risk of injury . There i females . However females . Recentl-1 on fitness, BP, body composition, lipids and CRP.The present study evaluates the efficacy of a workplace walking intervention on physical activity levels and cardiovascular risk factors. An examination of the effects of self-paced walking twice per week will reveal whether individuals can achieve health benefits from outdoor walking performed with minimal investment in time. The purpose of the present study was to examine the effects of 45 minutes walking, 2 d\u00b7 wkThis study was a randomised controlled trial, with subjects assigned to a walking or control group. The Research Ethics Committee at Queen's University, Belfast approved the study. Measurements were made at baseline (pre-intervention) and following eight weeks (post-intervention).-1, fasting blood glucose > 7.0 mmol\u00b7 L-1, body mass index (BMI) > 34.9 kg\u00b7 m-2, current cigarette smokers, individuals with cardiovascular, pulmonary or metabolic disease, pain or discomfort in the chest, dizziness or heart murmur. In addition, individuals taking medication known to interfere with lipid metabolism, and females who were pregnant or planning to become pregnant in the following five months were excluded from taking part in the study. Thirty seven subjects (24 women) aged 41.5 \u00b1 9.3 years were randomised to either a walking  or control group  on a 3 to 2 basis . All subjects gave their written informed consent.Subjects were recruited from staff at the Northern Ireland Civil Service via internal email. All subjects completed a Health History questionnaire. Exclusionary criteria were a physically active lifestyle , age > 65 years, resting BP > 159/99 mm Hg, total cholesterol > 6.2 mmol\u00b7 L2). Waist measurements were made at the level of the trunk where the girth is minimal, i.e. the location where there was a noticeable indentation of the trunk. If there was no noticeable indentation the tape was located at the umbilicus. Hip girth was the horizontal circumference at the broadest part of the lower body, usually at the level of the trochanters [Height and body mass were recorded using a stadiometer  and scales  respectively. BMI was calculated by dividing body mass (kg) by height  after the subject had rested in a seated position for five minutes. The average of the readings was used. If the first two readings differed by more than 5 mm Hg, an additional reading was obtained and all three readings averaged.max). They were encouraged to complete all four stages, but the test was terminated if heart rate (HR) reached 85% HRmax. HR was measured continually by short-range telemetry. During the last 30 seconds of each test stage, a capillary sample of blood was obtained and immediately analysed for lactate using a Lactate Pro Test Meter . Ratings of perceived exertion (RPE) using the Borg 15-grade scale  were obtained during the last minute of each test stage, in accordance with scripted instructions [To monitor cardiovascular adaptations to training, a submaximal, graded exercise test was conducted pre- and post-intervention. In the week prior to the treadmill test, subjects were familiarised with walking on the treadmill  at various speeds and slopes. Following a three minute warm-up, subjects were instructed to walk on the treadmill for four minutes at each of four gradients selected to elicit 40, 50, 60, and 70% of age-predicted (220 \u2013 age) maximum heart rate (HRructions -1) a value of 0.5 mg.L-1 was recorded. All samples for each given assay were analysed on the same day in a single batch at the Institute of Clinical Science at Queen's University, Belfast.Whole blood glucose and total cholesterol were determined from a fresh sample of capillary blood using dry chemistry methods  for the purpose of initial screening criteria. Blood samples were obtained by venepuncture after a 10 hour fast and with subjects in a seated position. Subjects were instructed to refrain from physical activity on the previous day. Samples were separated, frozen at -20\u00b0C, and analysed within 8 months. Total cholesterol, HDL and triglycerides were determined by automated enzyme assay using a Cobas FARA bioanalyser . Commercial enzyme assay kits were purchased from Randox Laboratories Ltd. . The concentration of LDL cholesterol was calculated using the Friedewald formula . CRP wasA sample of whole blood was analysed within 12 hours for haematocrit and haemoglobin. Haematocrit was corrected by 1.5% to account for plasma trapped between erythrocytes. Haematocrit and haemoglobin values were subsequently used to correct for changes in plasma volume . As femaIt has previously been reported that adults intuitively self-select a pace concordant with cardiorespiratory benefits when walking for exercise . TherefoTwelve walkers and all of the controls wore a pedometer during weeks 0, 4 and 8 of the intervention . They were instructed to wear the pedometer during all waking hours and record the number of steps taken at the end of each day. In addition, during weeks 4 and 8, those assigned to the walking group recorded their step count before and after each walking session in their training diary. Each subject was trained in the correct use of the pedometer and given written guidelines to follow.t-tests. Non-parametric Kruskall-Wallis tests were used to compare the step counts of groups at baseline. Non-parametric Wilcoxon tests were used to compare paired step count data of the walking group . Physiological data were analysed using a 2-way ANOVA with repeated measures, with one factor between subjects  and one factor within subjects (pre- vs. post-intervention).Physiological differences between groups at baseline were compared using independent -1, was excluded from the analysis as CRP values of this order may be indicative of infection or trauma . CRP data is therefore presented for 11 walkers and 8 controls. For all other parameters measured data are presented for the 21 walkers and 12 controls who completed the study. Physiological characteristics of the participants at baseline are shown in Table P > 0.05).Four individuals dropped out of the study due to: illness 1 control), moving job (1 control), family circumstances  and lack of interest . Due to equipment error at the end of the walking intervention, body fat measurement was only possible in 12 walkers and 12 controls. Due to problems in blood sampling we were only able to determine blood lipids  in 11 walkers and 9 controls. In addition one control subject, who had CRP values > 10 mg\u00b7 L control,P > 0.05). Daily step counts for the walking group on days when prescribed walking was performed , on days when no prescribed walking was performed (Rest-days) and all days during the programme are shown in Table P < 0.001). Walkers undertook more voluntary steps  on Rest-days (5803 \u00b1 2749) than on Walk-days (4567 \u00b1 2639) (P < 0.05). During the intervention, mean step counts for the control group averaged 6470 \u00b1 1709.During week 0 (i.e. the week prior to commencing the intervention) daily step counts for the walking and control groups averaged 6437 \u00b1 2285 and 6831 \u00b1 2727 respectively. There was no significant difference in the week 0 step counts between groups . Systolic BP for the walking group decreased from 120.4 \u00b1 19.7 mm Hg at baseline to 115.4 \u00b1 17.7 mm Hg at post intervention. Body fat percentage of the walking group was 28.0 \u00b1 5.8 and 27.9 \u00b1 5.6 at pre- and post-intervention respectively. No significant changes were observed in body mass, waist and hip circumference, diastolic BP or lipid variables.Table -1 respectively (n = 11). Corresponding values for controls were 1.5 \u00b1 1.5 and 1.5 \u00b1 1.3 mg\u00b7 L-1 at pre- and post-intervention respectively (n = 8). There were no significant effects observed. One subject, who had CRP values > 10 mg\u00b7 L-1, was excluded from the analysis as CRP values of this order may be indicative of infection or trauma .Mean values for CRP in the walking group at pre- and post-intervention were 1.9 \u00b1 1.7 and 1.6 \u00b1 1.5 mg\u00b7 L-1 and 112.0 \u00b1 9.3 beats\u00b7 min-1 at pre- and post-intervention respectively. Corresponding values for the control group were 121.2 \u00b1 14.7 and 118.1 \u00b1 13.0 beats\u00b7 min-1 at pre- and post-intervention respectively. Blood lactate values for walkers at pre-and post-intervention were 1.6 \u00b1 0.5 and 1.5 \u00b1 0.5 mmol\u00b7 L-1 respectively. Pre- and post-intervention values for the control group were 1.5 \u00b1 0.5 and 1.7 \u00b1 0.5 mmol\u00b7 L-1. Following training RPE during the treadmill test reduced from 11.2 \u00b1 1.4 to 10.8 \u00b1 1.4 in the walking group. A similar reduction was observed in controls, who demonstrated RPE values of 11.3 \u00b1 2.1 and 10.8 \u00b1 1.8 at pre- and post-intervention respectively. No significant differences were observed between groups in HR, blood lactate or RPE.Mean HR for the walking group during the treadmill test was 116.5 \u00b1 8.5 beats\u00b7 minThe main finding of the present study is that 45 minutes self-paced walking, two days per week, decreases systolic BP, but has no discernable effects on fitness, body mass, waist/hip circumferences, diastolic BP, CRP or lipoproteins, in previously sedentary employees. The novel aspect of this investigation is that it is the first to use a low frequency walking programme with adults < 60 years of age, and the first to examine the effects of walking, without dietary intervention, on CRP levels. The study augments the limited body of evidence on the efficacy of worksite physical activity interventions.A significant effect was observed between groups for the change in systolic BP from pre- to post-intervention. Systolic BP was reduced by 5.0 \u00b1 7.9 mm Hg in the walking group following eight weeks of training. A reduction of this magnitude is in general agreement with the findings of a meta-analysis on the effect of aerobic exercise on BP in normotensive adults . In suchFew other studies ,26 have A significant effect was observed between groups for change in body fat percentage from pre- to post-intervention. Relative to an increase in controls, the body fat percentage of walkers remained stable. The increases in body fat percentage of the control group may, however, be the result of over-cautious control subjects. It is possible that a desire 'not to be active' may have resulted in marginally lower than normal physical activity levels thus contributing to worsened adiposity.-1 vs. 150\u2013420 min\u00b7 wk-1). Given the varied training regimes in the aforementioned studies, and the paucity of data in the area, comparisons are difficult to draw. Further research is required to elucidate the relationship between exercise levels  and changes in CRP, and the effects of training in various population groups. The present study augments the very limited body of evidence on the effects of training on resting CRP concentrations.Participants in the present study are classified as being at moderate risk of future cardiovascular events according to their baseline CRP levels . In the -1 [max, heart rate during a submaximal exercise test was reduced. Failure to evoke changes in aerobic fitness in the present study, despite the same volume of exercise, may be due to differences in training intensity (67\u201378% HRmax vs. ~ 62% HRmax) or differences in the length of the intervention (26 weeks vs. 8 weeks) [max for lower-fit subjects [Heart rate and blood lactate responses to submaximal workloads were used in the present study to monitor changes in aerobic fitness. No significant effects were observed for changes in heart rate or lactate response to submaximal workloads. The authors know of one other study in the published literature that has used the same walking prescription as the present investigation. Eighty women, aged 60\u201370 years progressed to walking 45 minutes 2 d\u00b7 wk-1 . Followi8 weeks) . It has subjects . The facA systematic review of 32 cross-sectional, prospective observational and intervention studies, suggested that for adults, 7000 \u2013 13,000 steps per day can be expected . BaselinThe walking intervention was well tolerated by the employees in the present study. No injuries were reported during the programme, most likely due to the mode of exercise and that fact that low injury rates are associated with moderate intensity activity . This fi-1. However, apart from one subject, the same individuals were below detectable limits at both sampling times, thus limiting the resulting effect on observed changes over time.The limitations of this study need to be considered when interpreting findings. The CRP assay used in the present study did not detect CRP in the blood samples of 6 subject  as they were below the detectable level of < 0.5 mg\u00b7 L-1 for eight weeks at ~ 62% HRmax, reduces systolic BP and prevents an increase in body fat, in previously sedentary employees. This walking prescription, however, failed to induce significant improvements in fitness, diastolic BP, body mass, serum lipids and CRP levels. The walking programme was associated with high adherence. These findings support the use of a twice-weekly, self-paced, worksite based, walking programme, to improve activity levels and systolic BP in previously sedentary employees. There is little evidence however to support the use of this exercise prescription for improvements in other markers of CVD risk. This walking prescription may therefore be useful as a stepping-stone to further increase levels of exercise, which may then provide greater benefits.In summary, the findings of the present study suggest that self-paced walking 45 min, 2 d\u00b7 wkThe author(s) declare that they have no competing interests.MHM, EMM and CAGB were responsible for the design of the studyEMM was responsible for data collectionLGH was responsible for blood profilingAMN was responsible for statistical analysisMHM and EMM were responsible for preparing the manuscriptAll authors read and approved the final manuscriptThe pre-publication history for this paper can be accessed here:", "texts": ["Whether lower frequency, moderate intensity exercise alters cardiovascular disease (CVD) risk has received little attention. This study examined the effects of 45 minutes self-paced walking, 2 d\u00b7 wk37 subjects (24 women) aged 41.5 \u00b1 9.3 years were randomly assigned to either two 45 minute walks per week  or no training (control group). Aerobic fitness, body composition, blood pressure (BP), CRP and lipoprotein variables were measured at baseline and following 8 weeks. Steps counts were measured at baseline and during weeks 4 and 8 of the intervention.P < 0.05). There were no changes other risk factors. Subjects took significantly more steps on the days when prescribed walking was performed (9303 \u00b1 2665) compared to rest days .Compared to the control group, the walking group showed a significant reduction in systolic BP and maintained body fat levels (max, improves activity levels, reduces systolic BP and prevents an increase in body fat in previously sedentary adults. This walking prescription, however, failed to induce significant improvements in other markers of cardiovascular disease risk following eight weeks of training.These findings suggest that walking twice per week for 45 minutes at ~ 62% HR It has become increasingly clear that many of the chronic diseases we face today are associated fundamentally with the pervasive sedentariness of modern lifestyle. In Northern Ireland at least 2000 people die each year due to an inactive lifestyle and the avoidable cost of inactivity to the health service is estimated at \u00a30.62 million each year . DespiteIn the past decade, physical activity research has been characterised by the development of exercise prescriptions that are palatable to sedentary populations in the western world. First advocated by the American College of Sports Medicine  and subs-1 for six months, improved fitness in 79\u201391 year old females [Walking is eminently suited to population exercise prescription as it is easy to do, requires no special skills or facilities, and is achievable by virtually all age groups with little risk of injury . There i females . However females . Recentl-1 on fitness, BP, body composition, lipids and CRP.The present study evaluates the efficacy of a workplace walking intervention on physical activity levels and cardiovascular risk factors. An examination of the effects of self-paced walking twice per week will reveal whether individuals can achieve health benefits from outdoor walking performed with minimal investment in time. The purpose of the present study was to examine the effects of 45 minutes walking, 2 d\u00b7 wkThis study was a randomised controlled trial, with subjects assigned to a walking or control group. The Research Ethics Committee at Queen's University, Belfast approved the study. Measurements were made at baseline (pre-intervention) and following eight weeks (post-intervention).-1, fasting blood glucose > 7.0 mmol\u00b7 L-1, body mass index (BMI) > 34.9 kg\u00b7 m-2, current cigarette smokers, individuals with cardiovascular, pulmonary or metabolic disease, pain or discomfort in the chest, dizziness or heart murmur. In addition, individuals taking medication known to interfere with lipid metabolism, and females who were pregnant or planning to become pregnant in the following five months were excluded from taking part in the study. Thirty seven subjects (24 women) aged 41.5 \u00b1 9.3 years were randomised to either a walking  or control group  on a 3 to 2 basis . All subjects gave their written informed consent.Subjects were recruited from staff at the Northern Ireland Civil Service via internal email. All subjects completed a Health History questionnaire. Exclusionary criteria were a physically active lifestyle , age > 65 years, resting BP > 159/99 mm Hg, total cholesterol > 6.2 mmol\u00b7 L2). Waist measurements were made at the level of the trunk where the girth is minimal, i.e. the location where there was a noticeable indentation of the trunk. If there was no noticeable indentation the tape was located at the umbilicus. Hip girth was the horizontal circumference at the broadest part of the lower body, usually at the level of the trochanters [Height and body mass were recorded using a stadiometer  and scales  respectively. BMI was calculated by dividing body mass (kg) by height  after the subject had rested in a seated position for five minutes. The average of the readings was used. If the first two readings differed by more than 5 mm Hg, an additional reading was obtained and all three readings averaged.max). They were encouraged to complete all four stages, but the test was terminated if heart rate (HR) reached 85% HRmax. HR was measured continually by short-range telemetry. During the last 30 seconds of each test stage, a capillary sample of blood was obtained and immediately analysed for lactate using a Lactate Pro Test Meter . Ratings of perceived exertion (RPE) using the Borg 15-grade scale  were obtained during the last minute of each test stage, in accordance with scripted instructions [To monitor cardiovascular adaptations to training, a submaximal, graded exercise test was conducted pre- and post-intervention. In the week prior to the treadmill test, subjects were familiarised with walking on the treadmill  at various speeds and slopes. Following a three minute warm-up, subjects were instructed to walk on the treadmill for four minutes at each of four gradients selected to elicit 40, 50, 60, and 70% of age-predicted (220 \u2013 age) maximum heart rate (HRructions -1) a value of 0.5 mg.L-1 was recorded. All samples for each given assay were analysed on the same day in a single batch at the Institute of Clinical Science at Queen's University, Belfast.Whole blood glucose and total cholesterol were determined from a fresh sample of capillary blood using dry chemistry methods  for the purpose of initial screening criteria. Blood samples were obtained by venepuncture after a 10 hour fast and with subjects in a seated position. Subjects were instructed to refrain from physical activity on the previous day. Samples were separated, frozen at -20\u00b0C, and analysed within 8 months. Total cholesterol, HDL and triglycerides were determined by automated enzyme assay using a Cobas FARA bioanalyser . Commercial enzyme assay kits were purchased from Randox Laboratories Ltd. . The concentration of LDL cholesterol was calculated using the Friedewald formula . CRP wasA sample of whole blood was analysed within 12 hours for haematocrit and haemoglobin. Haematocrit was corrected by 1.5% to account for plasma trapped between erythrocytes. Haematocrit and haemoglobin values were subsequently used to correct for changes in plasma volume . As femaIt has previously been reported that adults intuitively self-select a pace concordant with cardiorespiratory benefits when walking for exercise . TherefoTwelve walkers and all of the controls wore a pedometer during weeks 0, 4 and 8 of the intervention . They were instructed to wear the pedometer during all waking hours and record the number of steps taken at the end of each day. In addition, during weeks 4 and 8, those assigned to the walking group recorded their step count before and after each walking session in their training diary. Each subject was trained in the correct use of the pedometer and given written guidelines to follow.t-tests. Non-parametric Kruskall-Wallis tests were used to compare the step counts of groups at baseline. Non-parametric Wilcoxon tests were used to compare paired step count data of the walking group . Physiological data were analysed using a 2-way ANOVA with repeated measures, with one factor between subjects  and one factor within subjects (pre- vs. post-intervention).Physiological differences between groups at baseline were compared using independent -1, was excluded from the analysis as CRP values of this order may be indicative of infection or trauma . CRP data is therefore presented for 11 walkers and 8 controls. For all other parameters measured data are presented for the 21 walkers and 12 controls who completed the study. Physiological characteristics of the participants at baseline are shown in Table P > 0.05).Four individuals dropped out of the study due to: illness 1 control), moving job (1 control), family circumstances  and lack of interest . Due to equipment error at the end of the walking intervention, body fat measurement was only possible in 12 walkers and 12 controls. Due to problems in blood sampling we were only able to determine blood lipids  in 11 walkers and 9 controls. In addition one control subject, who had CRP values > 10 mg\u00b7 L control,P > 0.05). Daily step counts for the walking group on days when prescribed walking was performed , on days when no prescribed walking was performed (Rest-days) and all days during the programme are shown in Table P < 0.001). Walkers undertook more voluntary steps  on Rest-days (5803 \u00b1 2749) than on Walk-days (4567 \u00b1 2639) (P < 0.05). During the intervention, mean step counts for the control group averaged 6470 \u00b1 1709.During week 0 (i.e. the week prior to commencing the intervention) daily step counts for the walking and control groups averaged 6437 \u00b1 2285 and 6831 \u00b1 2727 respectively. There was no significant difference in the week 0 step counts between groups . Systolic BP for the walking group decreased from 120.4 \u00b1 19.7 mm Hg at baseline to 115.4 \u00b1 17.7 mm Hg at post intervention. Body fat percentage of the walking group was 28.0 \u00b1 5.8 and 27.9 \u00b1 5.6 at pre- and post-intervention respectively. No significant changes were observed in body mass, waist and hip circumference, diastolic BP or lipid variables.Table -1 respectively (n = 11). Corresponding values for controls were 1.5 \u00b1 1.5 and 1.5 \u00b1 1.3 mg\u00b7 L-1 at pre- and post-intervention respectively (n = 8). There were no significant effects observed. One subject, who had CRP values > 10 mg\u00b7 L-1, was excluded from the analysis as CRP values of this order may be indicative of infection or trauma .Mean values for CRP in the walking group at pre- and post-intervention were 1.9 \u00b1 1.7 and 1.6 \u00b1 1.5 mg\u00b7 L-1 and 112.0 \u00b1 9.3 beats\u00b7 min-1 at pre- and post-intervention respectively. Corresponding values for the control group were 121.2 \u00b1 14.7 and 118.1 \u00b1 13.0 beats\u00b7 min-1 at pre- and post-intervention respectively. Blood lactate values for walkers at pre-and post-intervention were 1.6 \u00b1 0.5 and 1.5 \u00b1 0.5 mmol\u00b7 L-1 respectively. Pre- and post-intervention values for the control group were 1.5 \u00b1 0.5 and 1.7 \u00b1 0.5 mmol\u00b7 L-1. Following training RPE during the treadmill test reduced from 11.2 \u00b1 1.4 to 10.8 \u00b1 1.4 in the walking group. A similar reduction was observed in controls, who demonstrated RPE values of 11.3 \u00b1 2.1 and 10.8 \u00b1 1.8 at pre- and post-intervention respectively. No significant differences were observed between groups in HR, blood lactate or RPE.Mean HR for the walking group during the treadmill test was 116.5 \u00b1 8.5 beats\u00b7 minThe main finding of the present study is that 45 minutes self-paced walking, two days per week, decreases systolic BP, but has no discernable effects on fitness, body mass, waist/hip circumferences, diastolic BP, CRP or lipoproteins, in previously sedentary employees. The novel aspect of this investigation is that it is the first to use a low frequency walking programme with adults < 60 years of age, and the first to examine the effects of walking, without dietary intervention, on CRP levels. The study augments the limited body of evidence on the efficacy of worksite physical activity interventions.A significant effect was observed between groups for the change in systolic BP from pre- to post-intervention. Systolic BP was reduced by 5.0 \u00b1 7.9 mm Hg in the walking group following eight weeks of training. A reduction of this magnitude is in general agreement with the findings of a meta-analysis on the effect of aerobic exercise on BP in normotensive adults . In suchFew other studies ,26 have A significant effect was observed between groups for change in body fat percentage from pre- to post-intervention. Relative to an increase in controls, the body fat percentage of walkers remained stable. The increases in body fat percentage of the control group may, however, be the result of over-cautious control subjects. It is possible that a desire 'not to be active' may have resulted in marginally lower than normal physical activity levels thus contributing to worsened adiposity.-1 vs. 150\u2013420 min\u00b7 wk-1). Given the varied training regimes in the aforementioned studies, and the paucity of data in the area, comparisons are difficult to draw. Further research is required to elucidate the relationship between exercise levels  and changes in CRP, and the effects of training in various population groups. The present study augments the very limited body of evidence on the effects of training on resting CRP concentrations.Participants in the present study are classified as being at moderate risk of future cardiovascular events according to their baseline CRP levels . In the -1 [max, heart rate during a submaximal exercise test was reduced. Failure to evoke changes in aerobic fitness in the present study, despite the same volume of exercise, may be due to differences in training intensity (67\u201378% HRmax vs. ~ 62% HRmax) or differences in the length of the intervention (26 weeks vs. 8 weeks) [max for lower-fit subjects [Heart rate and blood lactate responses to submaximal workloads were used in the present study to monitor changes in aerobic fitness. No significant effects were observed for changes in heart rate or lactate response to submaximal workloads. The authors know of one other study in the published literature that has used the same walking prescription as the present investigation. Eighty women, aged 60\u201370 years progressed to walking 45 minutes 2 d\u00b7 wk-1 . Followi8 weeks) . It has subjects . The facA systematic review of 32 cross-sectional, prospective observational and intervention studies, suggested that for adults, 7000 \u2013 13,000 steps per day can be expected . BaselinThe walking intervention was well tolerated by the employees in the present study. No injuries were reported during the programme, most likely due to the mode of exercise and that fact that low injury rates are associated with moderate intensity activity . This fi-1. However, apart from one subject, the same individuals were below detectable limits at both sampling times, thus limiting the resulting effect on observed changes over time.The limitations of this study need to be considered when interpreting findings. The CRP assay used in the present study did not detect CRP in the blood samples of 6 subject  as they were below the detectable level of < 0.5 mg\u00b7 L-1 for eight weeks at ~ 62% HRmax, reduces systolic BP and prevents an increase in body fat, in previously sedentary employees. This walking prescription, however, failed to induce significant improvements in fitness, diastolic BP, body mass, serum lipids and CRP levels. The walking programme was associated with high adherence. These findings support the use of a twice-weekly, self-paced, worksite based, walking programme, to improve activity levels and systolic BP in previously sedentary employees. There is little evidence however to support the use of this exercise prescription for improvements in other markers of CVD risk. This walking prescription may therefore be useful as a stepping-stone to further increase levels of exercise, which may then provide greater benefits.In summary, the findings of the present study suggest that self-paced walking 45 min, 2 d\u00b7 wkThe author(s) declare that they have no competing interests.MHM, EMM and CAGB were responsible for the design of the studyEMM was responsible for data collectionLGH was responsible for blood profilingAMN was responsible for statistical analysisMHM and EMM were responsible for preparing the manuscriptAll authors read and approved the final manuscriptThe pre-publication history for this paper can be accessed here:"]}
{"representative": "We previously reported widespread insecticide exposure during pregnancy among inner-city women from New York City. Here we report on a pilot intervention using integrated pest management (IPM) to reduce pest infestations and residential insecticide exposures among pregnant New York City African-American and Latina women (25 intervention and 27 control homes).The IPM consisted of professional cleaning, sealing of pest entry points, application of low-toxicity pesticides, and education. Cockroach infestation levels and 2-week integrated indoor air samples were collected at baseline and one month postintervention. The insecticides detected in the indoor air samples were also measured in maternal and umbilical cord blood collected at delivery.p = 0.016) after the intervention among intervention cases but not control households. Among the intervention group, levels of piperonyl butoxide (a pyrethroid synergist) were significantly lower in indoor air samples after the intervention (p = 0.016). Insecticides were detected in maternal blood samples collected at delivery from controls but not from the intervention group. The difference was significant for trans-permethrin (p = 0.008) and of borderline significance (p = 0.1) for cis-permethrin and 2-isopropoxyphenol (a propoxur metabolite).Cockroach infestations decreased significantly (To our knowledge, this is the first study to use biologic dosimeters of prenatal pesticide exposure for assessing effectiveness of IPM. These pilot data suggest that IPM is an effective strategy for reducing pest infestation levels and the internal dose of insecticides during pregnancy. TherefoIntegrated pest management (IPM) is considered an environmentally sustainable pest control strategy. It aims to reduce pest populations by identifying and understanding the biology and behavior of the insects and rodents; selecting and implementing a set of environmentally safe and effective control strategies; and monitoring the effectiveness of the strategies . TechniqThe current study is the first to use bio-markers and air monitoring to document changes in insecticide exposure after an IPM intervention. The IPM strategy used here was adapted from the Columbia Intervention to Reduce Indoor Allergens Study . The aimRecruitment and enrollment efforts for the intervention study occurred from August 2002 through April 2004. Thirty women were recruited from obstetrics and gynecology (OB/GYN) clinics located in New York Presbyterian and Harlem Hospitals. Eligibility was restricted to women 18\u201335 years of age who self-identified as either African American or Latina (Dominican or Puerto Rican) and reported using high-toxicity insecticides  during pregnancy. Further, eligible subjects must have resided in northern Manhattan (north of 110th Street) or the South Bronx (south of Fordham Road) for at least 1 year before pregnancy and must not be planning to move from the community before delivery. From the 30 subjects who completed the screening and consent forms, 5 women dropped from the study between enrollment and monitoring . Samples collected from the subjects before the intervention will be referred to as preintervention, and samples collected after the intervention will be referred to as postintervention. From the remaining 25 women, 25 (100%) completed the prenatal questionnaire, 25 (100%) participated in pre- and postintervention indoor air monitoring, and biologic samples were collected from 21 (84%) subjects. Nineteen (76%) completed pre- and postintervention assessment of pest infestation.The control group was selected from participants in an ongoing prospective cohort study designed to validate biomarkers of prenatal insecticide exposure. As part of this study, insecticide levels were measured in 2-week integrated indoor air samples collected continuously over the last 2 months of pregnancy. Blood samples were collected from the mother and newborn at delivery. Enrollment for this study occurred in the OB/GYN clinics located in New York Presbyterian Hospital and Harlem Hospital from October 2001 through July 2004. The recruitment strategy and eligibility criteria for the controls were identical to those for the cases. From the total of 110 women fully enrolled in the biomarker validation study, 27 were selected as controls for the intervention study. Control selection aimed to match case subjects on year of enrollment (2002\u20132004) and self-reported use of high-toxicity insecticides  during pregnancy. Baseline and follow-up integrated air samples were selected to match the pre- and postintervention samples in the cases. Questionnaire data were available for 100% of subjects. Baseline and follow-up indoor air data were available for 24 (88%) subjects; blood samples were collected from 17 (63%) subjects. Fourteen (52%) subjects completed the initial pest infestation levels. Follow-up samples were available for only six (22%) subjects.The institutional review board of the Columbia Presbyterian Medical Center approved the study, and we obtained written informed consent from all study subjects.The intervention commenced at the conclusion of the 2-week preintervention monitoring period. This IPM consisted of three main components: an extensive cleaning with minor building repairs, a low-toxicity insecticide application, and behavioral/health education. The kitchen, bathroom, and living room areas of the intervention apartments were professionally cleaned using low-toxicity, citrus-based cleaning products. Pest entry points were sealed with caulking compounds and/or metal screens. A professional insecticide placement company injected low-toxicity insecticides, 2.15% hydramethylnon , or small amounts of boric acid directly into the cracks and holes before sealing and placed glue traps for cockroaches throughout the kitchen, bathroom, and problem areas. Hydramethylnon has low toxicity and low vapor pressure and has been shown previously to be effective for long-term cockroach control . Using aA 45-minute questionnaire was administered to the intervention and control groups in each woman\u2019s home by a trained bilingual interviewer during the third trimester of pregnancy. The questionnaire included information on demographics, home characteristics including housing disrepair and pest infestation levels, lifetime residential history, history of active and passive smoking, occupational history, maternal education and income level, alcohol and drug use during pregnancy, and history of residential insecticide use. Information about insecticide use included whether or not any pest control measures were used by an exterminator or by others  during pregnancy and, if so, what types of measures were used and at what frequency , 2003.Before the intervention, a baseline 2-week integrated indoor air sample was collected from the homes of subjects in the intervention and control groups. Monitoring commenced in each home at the end of the second or beginning of the third trimester of pregnancy using a BGI pump with a 0.5-L/min flow-rate . The pump was attached to a URG  polyurethrane foam (PUF) sampler with a 2.5-\u03bcm inlet cut fitted with a 30-mm quartz fiber filter and a foam cartridge backup to capture semivolatile vapors and aerosols. The pumps were attached to a battery and operated continuously over the 2 weeks. The monitoring equipment was placed in the main living area of the apartment, with the pump in a secure box and the sampler (located inside a protective wire cage) placed at least 60 cm from wall surfaces at a height of 135 cm. The sampler height was chosen to represent the average between the woman\u2019s sitting and standing heights, because residential insecticide air concentrations have been shown to vary with height, being greatest near the floor . Study sApproximately 4 weeks after the intervention, a follow-up 2-week integrated indoor air sample was collected from intervention and control homes. Protocols for the follow-up air monitoring were identical to those for the baseline sample. The monitoring was targeted to occur during the 38th to 40th week of pregnancy; however, because of premature births or postponements, some subject\u2019s homes were monitored immediately after delivery.To monitor cockroach infestation levels, six pheromone glue traps  were placed in standardized locations throughout the kitchens of each subject during the 2-week baseline and follow-up indoor air monitorings. After 2 weeks, traps were collected and the number of adult and nymph cockroaches caught in each trap was counted.We used blood collection procedures validated in our prior research studies to ensure that blood samples  were collected from women in the intervention and control groups at delivery . A sampl14 as a recovery surrogate, extracted with 6% diethyl ether in hexane for 16 hr and concentrated to 1.0 mL in 10% ether in hexanes. Extracts were stored frozen below \u22124\u00b0C. Insecticides are stable in the extract under these conditions. We determined the amounts of the target insecticides in samples using Agilent 6890/5973 gas chromatography/mass spectrometry  in selected ion mode. Paired pre- and postintervention air samples were available on 25 cases and 39 controls. The target insecticides that were measured in the indoor air samples were bendiocarb, carbaryl, carbofuran, cis- and trans-permethrin, malathion, methyl parathion and propoxur. In addition, piperonyl butoxide, a synergist added to natural and synthetic pyrethroid insecticides, was measured as an indicator of pyrethroid insecticides. Chlorpyrifos and diazinon were not assessed because most of the women were enrolled in the study after the federal ban on their residential use and our prior data indicate that the ban was effective at reducing use and exposures to these insecticides among inner-city women in New York City  a value of 0.5 \u00d7 LOD. For hypothesis testing, variables were treated as continuous or categorical depending on their distributional properties. Continuous variables were initially log-transformed as appropriate to normalize the distribution. However, in almost all cases, the data could not be normally distributed after log-transformation, so nonparametric statistics were used. The differences in pest infestation levels and air insecticide levels between pre- and postintervention in both cases and controls were normally distributed, so we used parametric statistics to evaluate whether these differences varied significantly between the intervention and control group. Analyses were also undertaken to determine whether the intervention and control groups differed in terms of demographic characteristics or season and year of delivery. No significant differences were seen.t-test to determine whether the differences in pest infestation levels between pre- and postintervention observed in the intervention group were significantly different from the differences in pest infestation levels observed in the control group.For pest infestation levels, we used the Wilcoxon signed-rank test to assess the differences between pre- and postintervention pest infestation levels in both intervention and control groups. Because the differences in pest infestation levels were normally distributed, we used the independent sample t-tests and regression analyses controlling for race/ethnicity, season, and year of delivery to compare whether the change in air insecticide levels between pre- and postintervention differed significantly between the intervention and control groups. For insecticide levels in maternal and cord blood samples, we compared differences in detection frequencies between intervention and control subjects using chi-square analyses (Fisher\u2019s exact test). Results were considered significant at p < 0.05 (two-tailed).For 2-week integrated air insecticide levels, we compared detection frequencies as well as detection levels. We used McNemar\u2019s test to examine the change in detection frequency of insecticide levels in air between pre- and postintervention in both the intervention and control groups. We used the Wilcoxon signed-rank test to examine the change in insecticide levels between pre- and postintervention for both groups. Finally, we used the independent sample p = 0.008, 0.05, and 0.012, respectively). Participants included 25 intervention cases and 27 nonintervention controls. Demographic characteristics were compared between cases and controls and were generally comparable between the two groups . Discrepp = 0.016) (p = 0.006) and nymph cockroaches decreased by 44% (p = 0.033). By contrast, control households showed no significant reduction of adult or nymph cockroaches between baseline and follow-up  . Adult cw-up see . Howeverw-up see .cis- and trans-permethrin in approximately 30% of pre- and 15% of postintervention samples and 24 and 16% of baseline control samples and 17 and 13% of follow-up control samples, respectively. In addition, piperonyl butoxide was detected in 71% of pre- and postintervention samples and 72 and 57% of baseline and follow-up control samples, respectively. The mean levels for these compounds in pre- and postintervention 2-week integrated indoor air samples are presented in Of the nine insecticides measured in 2-week integrated indoor air samples, five insecticides  were not detected or were found in < 10% of either intervention or control samples. Of the remaining insecticides, propoxur was detected in 92% of pre- and postintervention case samples and 100% of baseline and follow-up control samples; and p = 0.016). Of the 23 intervention homes with available air sampling, a decrease in piperonyl butoxide was seen in 74% (17/23) of homes, whereas an increase was seen in 26% (6/23) of homes. Piperonyl butoxide levels also decreased in control homes, but not significantly (p = 0.08). The difference between pre- and postintervention levels of piperonyl butoxide in the intervention group was not significantly different from the difference between baseline to follow-up levels in the controls .Among the intervention group, only piper-onyl butoxide decreased significantly after the intervention . The meacis- and trans-permethrin (two isomers of the pyrethroid insecticide permethrin). These insecticides were detected in plasma samples from the control group but not from the intervention group. Specifically, 2-isopropoxy-phenol was detected in 0% of maternal blood samples from the intervention group and in 12% of maternal blood samples from controls . Cis- and trans-permethrin were detected in 0% of maternal blood samples from intervention group and 12 and 29% of maternal blood samples from controls, differences that were significant for trans-permethrin  (= 0.008) . None ofThis pilot intervention study demonstrates that IPM can have a significant effect on pest infestation levels and appears to reduce residential insecticide exposures during pregnancy. Our findings showing significant reductions in cockroach populations are consistent with those of other intervention studies that focused on reducing either pest infestations or allergen levels related to pest infestation . To our Success of IPM interventions has been attributed to simultaneous application of multiple nonchemical approaches to pest control, including education, repair, least-toxic exterminations, reinforcement, and repetition . In our Despite the dual goal of IPM to reduce cockroach and insecticide exposures, most IPM evaluations have focused on the reduction of pests. Data on the effectiveness of reducing insecticide exposure are limited, and documented in only two studies. A building-wide intervention in New York City public housing found resident\u2019s use of spray insecticides and Chinese Chalk, an illegal insecticide, dropped to zero after a building-wide IPM intervention that included education about the safe use of insecticides . An IPM intervention in Canada found decreases in both personal use of spray insecticides and resident requests for exterminators to use spray insecticides in their apartment, requesting instead lower-toxicity pastes or gels . Althougcis-permethrin and trans-permethrin, and the pyrethroid synergist piperonyl butoxide. Selection of these insecticides was based on evidence that they were widely used for residential pest control (trans-isomer of permethrin were lower in maternal plasma samples collected from the intervention group than in controls.In the present study, target insecticides in indoor air samples included the carbamate, propoxur, the pyrethroids  control . Detecti control , 2004. T control . In our However, these findings should be interpreted with caution, particularly because results for propoxur do not mirror those seen for piperonyl butoxide. Specifically, propoxur levels in indoor air samples decreased in follow-up compared with baseline air samples among control households, but not among intervention households. Propoxur is a carbamate licensed for residential pest control and has not been subject to regulatory restrictions, as have the organophosphates, chlorpyrifos, and diazinon. However, our prior data suggest that propoxur use in inner-city communities in New York City may be decreasing. Specifically, we found a highly significant decrease in propoxur levels between 1999 and 2001 in personal air samples collected from African-American and Dominican women in New York City during pregnancy and in the corresponding blood samples collected from the mothers and newborns at delivery , 2004. UAlthough this pilot intervention indicated that IPM is effective at reducing pest infestation and the internal dose of the insecticides during pregnancy, limitations in the study design should be noted. The primary limitation of the study is the small sample size and the short time elapsed between pre- and postintervention monitoring. Many intervention studies allow 6 months to 1 year between samplings to determine if the intervention is both successful and sustainable. However, the current intervention was conducted during pregnancy and was thus limited in follow-up time. Further, the controls were selected from an ongoing biomarker validation study that followed women only during pregnancy. Thus we were not able to evaluate the sustainability of the intervention over an extended period. In addition, the optimal design for an intervention study is to match the intervention subjects to control subjects and have all data collected and analyzed simultaneously. This was not possible here because the controls were selected from ongoing research. However, the intervention and control groups were comparable in terms of years of enrollment and self-reported pesticide use.A principal goal of the pilot study was to assess whether environmental and biologic measures can be used in evaluating the efficacy of IPM interventions in reducing residential pesticide exposures. These initial results are promising, although additional research is warranted given the small sample size and inconsistency in some of the findings. Environmental measures for the targeted pesticides are not necessarily associated with the biologic measures. Therefore, a lack of meaningfully different results in air levels of pesticides between the intervention and control groups does not influence the expected results in maternal plasma between the two groups. Subsequent research could also draw on our study design to devise an IPM intervention that can be conducted by household members themselves and that is both feasible and affordable. Such an intervention could be applied to entire apartment buildings or complexes to determine the effects of larger-scale interventions, as opposed to individual units. In the current study, cleaning and home repairs were completed by a professional cleaning crew to allow comparability and consistency. However, the supplies and techniques are similar to those available in the community. In conclusion, we believe that this intervention protocol using IPM can be successfully adapted for use by individuals within households in this community to reduce pest infestation levels and residential pesticide exposure.", "texts": ["We previously reported widespread insecticide exposure during pregnancy among inner-city women from New York City. Here we report on a pilot intervention using integrated pest management (IPM) to reduce pest infestations and residential insecticide exposures among pregnant New York City African-American and Latina women (25 intervention and 27 control homes).The IPM consisted of professional cleaning, sealing of pest entry points, application of low-toxicity pesticides, and education. Cockroach infestation levels and 2-week integrated indoor air samples were collected at baseline and one month postintervention. The insecticides detected in the indoor air samples were also measured in maternal and umbilical cord blood collected at delivery.p = 0.016) after the intervention among intervention cases but not control households. Among the intervention group, levels of piperonyl butoxide (a pyrethroid synergist) were significantly lower in indoor air samples after the intervention (p = 0.016). Insecticides were detected in maternal blood samples collected at delivery from controls but not from the intervention group. The difference was significant for trans-permethrin (p = 0.008) and of borderline significance (p = 0.1) for cis-permethrin and 2-isopropoxyphenol (a propoxur metabolite).Cockroach infestations decreased significantly (To our knowledge, this is the first study to use biologic dosimeters of prenatal pesticide exposure for assessing effectiveness of IPM. These pilot data suggest that IPM is an effective strategy for reducing pest infestation levels and the internal dose of insecticides during pregnancy. TherefoIntegrated pest management (IPM) is considered an environmentally sustainable pest control strategy. It aims to reduce pest populations by identifying and understanding the biology and behavior of the insects and rodents; selecting and implementing a set of environmentally safe and effective control strategies; and monitoring the effectiveness of the strategies . TechniqThe current study is the first to use bio-markers and air monitoring to document changes in insecticide exposure after an IPM intervention. The IPM strategy used here was adapted from the Columbia Intervention to Reduce Indoor Allergens Study . The aimRecruitment and enrollment efforts for the intervention study occurred from August 2002 through April 2004. Thirty women were recruited from obstetrics and gynecology (OB/GYN) clinics located in New York Presbyterian and Harlem Hospitals. Eligibility was restricted to women 18\u201335 years of age who self-identified as either African American or Latina (Dominican or Puerto Rican) and reported using high-toxicity insecticides  during pregnancy. Further, eligible subjects must have resided in northern Manhattan (north of 110th Street) or the South Bronx (south of Fordham Road) for at least 1 year before pregnancy and must not be planning to move from the community before delivery. From the 30 subjects who completed the screening and consent forms, 5 women dropped from the study between enrollment and monitoring . Samples collected from the subjects before the intervention will be referred to as preintervention, and samples collected after the intervention will be referred to as postintervention. From the remaining 25 women, 25 (100%) completed the prenatal questionnaire, 25 (100%) participated in pre- and postintervention indoor air monitoring, and biologic samples were collected from 21 (84%) subjects. Nineteen (76%) completed pre- and postintervention assessment of pest infestation.The control group was selected from participants in an ongoing prospective cohort study designed to validate biomarkers of prenatal insecticide exposure. As part of this study, insecticide levels were measured in 2-week integrated indoor air samples collected continuously over the last 2 months of pregnancy. Blood samples were collected from the mother and newborn at delivery. Enrollment for this study occurred in the OB/GYN clinics located in New York Presbyterian Hospital and Harlem Hospital from October 2001 through July 2004. The recruitment strategy and eligibility criteria for the controls were identical to those for the cases. From the total of 110 women fully enrolled in the biomarker validation study, 27 were selected as controls for the intervention study. Control selection aimed to match case subjects on year of enrollment (2002\u20132004) and self-reported use of high-toxicity insecticides  during pregnancy. Baseline and follow-up integrated air samples were selected to match the pre- and postintervention samples in the cases. Questionnaire data were available for 100% of subjects. Baseline and follow-up indoor air data were available for 24 (88%) subjects; blood samples were collected from 17 (63%) subjects. Fourteen (52%) subjects completed the initial pest infestation levels. Follow-up samples were available for only six (22%) subjects.The institutional review board of the Columbia Presbyterian Medical Center approved the study, and we obtained written informed consent from all study subjects.The intervention commenced at the conclusion of the 2-week preintervention monitoring period. This IPM consisted of three main components: an extensive cleaning with minor building repairs, a low-toxicity insecticide application, and behavioral/health education. The kitchen, bathroom, and living room areas of the intervention apartments were professionally cleaned using low-toxicity, citrus-based cleaning products. Pest entry points were sealed with caulking compounds and/or metal screens. A professional insecticide placement company injected low-toxicity insecticides, 2.15% hydramethylnon , or small amounts of boric acid directly into the cracks and holes before sealing and placed glue traps for cockroaches throughout the kitchen, bathroom, and problem areas. Hydramethylnon has low toxicity and low vapor pressure and has been shown previously to be effective for long-term cockroach control . Using aA 45-minute questionnaire was administered to the intervention and control groups in each woman\u2019s home by a trained bilingual interviewer during the third trimester of pregnancy. The questionnaire included information on demographics, home characteristics including housing disrepair and pest infestation levels, lifetime residential history, history of active and passive smoking, occupational history, maternal education and income level, alcohol and drug use during pregnancy, and history of residential insecticide use. Information about insecticide use included whether or not any pest control measures were used by an exterminator or by others  during pregnancy and, if so, what types of measures were used and at what frequency , 2003.Before the intervention, a baseline 2-week integrated indoor air sample was collected from the homes of subjects in the intervention and control groups. Monitoring commenced in each home at the end of the second or beginning of the third trimester of pregnancy using a BGI pump with a 0.5-L/min flow-rate . The pump was attached to a URG  polyurethrane foam (PUF) sampler with a 2.5-\u03bcm inlet cut fitted with a 30-mm quartz fiber filter and a foam cartridge backup to capture semivolatile vapors and aerosols. The pumps were attached to a battery and operated continuously over the 2 weeks. The monitoring equipment was placed in the main living area of the apartment, with the pump in a secure box and the sampler (located inside a protective wire cage) placed at least 60 cm from wall surfaces at a height of 135 cm. The sampler height was chosen to represent the average between the woman\u2019s sitting and standing heights, because residential insecticide air concentrations have been shown to vary with height, being greatest near the floor . Study sApproximately 4 weeks after the intervention, a follow-up 2-week integrated indoor air sample was collected from intervention and control homes. Protocols for the follow-up air monitoring were identical to those for the baseline sample. The monitoring was targeted to occur during the 38th to 40th week of pregnancy; however, because of premature births or postponements, some subject\u2019s homes were monitored immediately after delivery.To monitor cockroach infestation levels, six pheromone glue traps  were placed in standardized locations throughout the kitchens of each subject during the 2-week baseline and follow-up indoor air monitorings. After 2 weeks, traps were collected and the number of adult and nymph cockroaches caught in each trap was counted.We used blood collection procedures validated in our prior research studies to ensure that blood samples  were collected from women in the intervention and control groups at delivery . A sampl14 as a recovery surrogate, extracted with 6% diethyl ether in hexane for 16 hr and concentrated to 1.0 mL in 10% ether in hexanes. Extracts were stored frozen below \u22124\u00b0C. Insecticides are stable in the extract under these conditions. We determined the amounts of the target insecticides in samples using Agilent 6890/5973 gas chromatography/mass spectrometry  in selected ion mode. Paired pre- and postintervention air samples were available on 25 cases and 39 controls. The target insecticides that were measured in the indoor air samples were bendiocarb, carbaryl, carbofuran, cis- and trans-permethrin, malathion, methyl parathion and propoxur. In addition, piperonyl butoxide, a synergist added to natural and synthetic pyrethroid insecticides, was measured as an indicator of pyrethroid insecticides. Chlorpyrifos and diazinon were not assessed because most of the women were enrolled in the study after the federal ban on their residential use and our prior data indicate that the ban was effective at reducing use and exposures to these insecticides among inner-city women in New York City  a value of 0.5 \u00d7 LOD. For hypothesis testing, variables were treated as continuous or categorical depending on their distributional properties. Continuous variables were initially log-transformed as appropriate to normalize the distribution. However, in almost all cases, the data could not be normally distributed after log-transformation, so nonparametric statistics were used. The differences in pest infestation levels and air insecticide levels between pre- and postintervention in both cases and controls were normally distributed, so we used parametric statistics to evaluate whether these differences varied significantly between the intervention and control group. Analyses were also undertaken to determine whether the intervention and control groups differed in terms of demographic characteristics or season and year of delivery. No significant differences were seen.t-test to determine whether the differences in pest infestation levels between pre- and postintervention observed in the intervention group were significantly different from the differences in pest infestation levels observed in the control group.For pest infestation levels, we used the Wilcoxon signed-rank test to assess the differences between pre- and postintervention pest infestation levels in both intervention and control groups. Because the differences in pest infestation levels were normally distributed, we used the independent sample t-tests and regression analyses controlling for race/ethnicity, season, and year of delivery to compare whether the change in air insecticide levels between pre- and postintervention differed significantly between the intervention and control groups. For insecticide levels in maternal and cord blood samples, we compared differences in detection frequencies between intervention and control subjects using chi-square analyses (Fisher\u2019s exact test). Results were considered significant at p < 0.05 (two-tailed).For 2-week integrated air insecticide levels, we compared detection frequencies as well as detection levels. We used McNemar\u2019s test to examine the change in detection frequency of insecticide levels in air between pre- and postintervention in both the intervention and control groups. We used the Wilcoxon signed-rank test to examine the change in insecticide levels between pre- and postintervention for both groups. Finally, we used the independent sample p = 0.008, 0.05, and 0.012, respectively). Participants included 25 intervention cases and 27 nonintervention controls. Demographic characteristics were compared between cases and controls and were generally comparable between the two groups . Discrepp = 0.016) (p = 0.006) and nymph cockroaches decreased by 44% (p = 0.033). By contrast, control households showed no significant reduction of adult or nymph cockroaches between baseline and follow-up  . Adult cw-up see . Howeverw-up see .cis- and trans-permethrin in approximately 30% of pre- and 15% of postintervention samples and 24 and 16% of baseline control samples and 17 and 13% of follow-up control samples, respectively. In addition, piperonyl butoxide was detected in 71% of pre- and postintervention samples and 72 and 57% of baseline and follow-up control samples, respectively. The mean levels for these compounds in pre- and postintervention 2-week integrated indoor air samples are presented in Of the nine insecticides measured in 2-week integrated indoor air samples, five insecticides  were not detected or were found in < 10% of either intervention or control samples. Of the remaining insecticides, propoxur was detected in 92% of pre- and postintervention case samples and 100% of baseline and follow-up control samples; and p = 0.016). Of the 23 intervention homes with available air sampling, a decrease in piperonyl butoxide was seen in 74% (17/23) of homes, whereas an increase was seen in 26% (6/23) of homes. Piperonyl butoxide levels also decreased in control homes, but not significantly (p = 0.08). The difference between pre- and postintervention levels of piperonyl butoxide in the intervention group was not significantly different from the difference between baseline to follow-up levels in the controls .Among the intervention group, only piper-onyl butoxide decreased significantly after the intervention . The meacis- and trans-permethrin (two isomers of the pyrethroid insecticide permethrin). These insecticides were detected in plasma samples from the control group but not from the intervention group. Specifically, 2-isopropoxy-phenol was detected in 0% of maternal blood samples from the intervention group and in 12% of maternal blood samples from controls . Cis- and trans-permethrin were detected in 0% of maternal blood samples from intervention group and 12 and 29% of maternal blood samples from controls, differences that were significant for trans-permethrin  (= 0.008) . None ofThis pilot intervention study demonstrates that IPM can have a significant effect on pest infestation levels and appears to reduce residential insecticide exposures during pregnancy. Our findings showing significant reductions in cockroach populations are consistent with those of other intervention studies that focused on reducing either pest infestations or allergen levels related to pest infestation . To our Success of IPM interventions has been attributed to simultaneous application of multiple nonchemical approaches to pest control, including education, repair, least-toxic exterminations, reinforcement, and repetition . In our Despite the dual goal of IPM to reduce cockroach and insecticide exposures, most IPM evaluations have focused on the reduction of pests. Data on the effectiveness of reducing insecticide exposure are limited, and documented in only two studies. A building-wide intervention in New York City public housing found resident\u2019s use of spray insecticides and Chinese Chalk, an illegal insecticide, dropped to zero after a building-wide IPM intervention that included education about the safe use of insecticides . An IPM intervention in Canada found decreases in both personal use of spray insecticides and resident requests for exterminators to use spray insecticides in their apartment, requesting instead lower-toxicity pastes or gels . Althougcis-permethrin and trans-permethrin, and the pyrethroid synergist piperonyl butoxide. Selection of these insecticides was based on evidence that they were widely used for residential pest control (trans-isomer of permethrin were lower in maternal plasma samples collected from the intervention group than in controls.In the present study, target insecticides in indoor air samples included the carbamate, propoxur, the pyrethroids  control . Detecti control , 2004. T control . In our However, these findings should be interpreted with caution, particularly because results for propoxur do not mirror those seen for piperonyl butoxide. Specifically, propoxur levels in indoor air samples decreased in follow-up compared with baseline air samples among control households, but not among intervention households. Propoxur is a carbamate licensed for residential pest control and has not been subject to regulatory restrictions, as have the organophosphates, chlorpyrifos, and diazinon. However, our prior data suggest that propoxur use in inner-city communities in New York City may be decreasing. Specifically, we found a highly significant decrease in propoxur levels between 1999 and 2001 in personal air samples collected from African-American and Dominican women in New York City during pregnancy and in the corresponding blood samples collected from the mothers and newborns at delivery , 2004. UAlthough this pilot intervention indicated that IPM is effective at reducing pest infestation and the internal dose of the insecticides during pregnancy, limitations in the study design should be noted. The primary limitation of the study is the small sample size and the short time elapsed between pre- and postintervention monitoring. Many intervention studies allow 6 months to 1 year between samplings to determine if the intervention is both successful and sustainable. However, the current intervention was conducted during pregnancy and was thus limited in follow-up time. Further, the controls were selected from an ongoing biomarker validation study that followed women only during pregnancy. Thus we were not able to evaluate the sustainability of the intervention over an extended period. In addition, the optimal design for an intervention study is to match the intervention subjects to control subjects and have all data collected and analyzed simultaneously. This was not possible here because the controls were selected from ongoing research. However, the intervention and control groups were comparable in terms of years of enrollment and self-reported pesticide use.A principal goal of the pilot study was to assess whether environmental and biologic measures can be used in evaluating the efficacy of IPM interventions in reducing residential pesticide exposures. These initial results are promising, although additional research is warranted given the small sample size and inconsistency in some of the findings. Environmental measures for the targeted pesticides are not necessarily associated with the biologic measures. Therefore, a lack of meaningfully different results in air levels of pesticides between the intervention and control groups does not influence the expected results in maternal plasma between the two groups. Subsequent research could also draw on our study design to devise an IPM intervention that can be conducted by household members themselves and that is both feasible and affordable. Such an intervention could be applied to entire apartment buildings or complexes to determine the effects of larger-scale interventions, as opposed to individual units. In the current study, cleaning and home repairs were completed by a professional cleaning crew to allow comparability and consistency. However, the supplies and techniques are similar to those available in the community. In conclusion, we believe that this intervention protocol using IPM can be successfully adapted for use by individuals within households in this community to reduce pest infestation levels and residential pesticide exposure."]}
{"representative": "The prevalence of asthma and allergic diseases has increased in industrialised countries, and it is known that rates vary according whether the area is urban or rural and to socio-economic status. Surveys conducted in some urban settings in Latin America found high prevalence rates, only exceeded by the rates observed in industrialised English-speaking countries. It is likely that the marked changes in the environment, life style and living conditions in Latin America are responsible for these observations. The understanding of the epidemiological and immunological changes that underlie the increase in asthma and allergic diseases in Latin America aimed by SCAALA studies in Brazil and Ecuador will be crucial for the identification of novel preventive interventions.The Salvador-SCAALA project described here is a longitudinal study involving children aged 4\u201311 years living in the city of Salvador, Northeastern Brazil. Data on asthma and allergic diseases (rhinitis and eczema) and potential risk factors will be collected in successive surveys using standardised questionnaire. This will be completed with data on dust collection (to dust mite and endotoxin), skin test to most common allergens, stool examinations to helminth and parasites, blood samples , formaldehyde, physical inspection to diagnoses of eczema, and anthropometric measures. Data on earlier exposures when these children were 0\u20133 years old are available from a different project.It is expected that knowledge generated may help identify public health interventions that may enable countries in LA to enjoy the benefits of a \"modern\" lifestyle while avoiding \u2013 or minimising \u2013 increases in morbidity caused by asthma and allergies. The prevalence of asthma and allergic diseases (rhinitis and eczema) has increased in industrialised countries in the last 2 decades -3; in thAmong environmental exposures that may have contributed to the trends in allergy prevalence, those that have attracted most interest are the fall in exposures to infectious diseases. The so-called \"hygiene hypothesis\" proposed that increases in the prevalence of allergic diseases were explained by improvements in living conditions, use of antibiotics and childhood vaccinations leading to a reduction in exposure to infections in early life . DiffereWhatever the mechanisms involved the strong evidence that the temporal allergy trends are related to changes in lifestyle and living conditions raises the possibility that preventive interventions against allergic diseases can be identified. The understanding of the epidemiological and immunological changes that underlie the increase in asthma and allergic diseases will be crucial for the identification of novel preventive interventions.International studies of the asthma prevalence have been conducted with the International Study of Asthma and Allergies in Childhood (ISAAC) study group using a standardised written questionnaire for self-reported asthma and respiratory symptoms. In these surveys, some Latin American settings  had very high prevalence rates, that were exceeded only by industrialised English-speaking countries . These rThe study described here is part of a larger ongoing research programme being conducted in Brazil  and Ecuador. Populations in both countries have experienced recent changes in living conditions and life style . This research programme is funded by The Wellcome Trust through the programme of Major Awards to Centres of Excellence in Latin America and has adopted the name SCAALA . This paper specifically deals with the methodological aspects of the cohort study being conducted in Salvador, Brazil.The Salvador cohort study has two main objectives. Firstly, to investigate the associations between the prevalence of asthma and other allergic diseases  and potential risk factors that includes living conditions and early life and current exposures to infections, and secondly, to investigate how the association between environment factors, allergic diseases and markers of atopy  are mediated by serum interleukins. In contrast, the study in Ecuador aims to study frequency of atopy and allergic diseases and exposure to potential risk factor in rural populations and in migrants from rural to urban areas; and examine how these may explain the risk of atopic diseases in migrants from rural to urban areas. This study will be described in a separate paper.Salvador, the capital of the State of Bahia, in the Northeast Brazil has approximately 2.5 million inhabitants, and is located in the poorest region in the country. Over 80% of the population is black or mixed-race (mulatto). There is a high degree of social inequality: GINI coefficient was 0.66 in 2000 . The citChildren in this research project have been part of a study conducted earlier to evaluate the impact of the sanitation programme on the occurrence of childhood diarrhoea. This first study was originally designed to enrol three separate cohorts of children aged 0\u20133 years recruited from 24 small geographical areas selected to represent the population without sanitation in Salvador, called sentinel-areas ,17 TheseTo take advantage of these three cohorts , the children who were aged 4\u201311 years and had complete follow-up information (e.g. stool examination conducted at 3 different time points) were selected for the present study.Follow-up during the current study on asthma and allergic diseases consists of two additional surveys to be conducted between 2005 and 2006, and again in 2008. The two surveys will assess children from the three previous cohort studies and will: (i) update information collected in the baseline surveys (ii) collect information on additional risk factors, (iii) collect stool samples for diagnosis of intestinal parasitic infections, (iv) collect blood samples for immunological analysis, (v) collect dust to measure allergen exposure, (vi) collect data on formaldehyde and particulate levels indoors and outdoors and (vii) collect data on asthma and allergic diseases . The information collected during previous surveys and follow-up will be used in the present study to investigate early risk factors relating to infectious disease exposures and living conditions of the children from birth. All children from the previous 3 cohort studies were eligible to enter the present study.The total number of children recruited in the first resurvey with questionnaires completed was 1,445. Given this total number of children recruited, the magnitude of the prevalence rate ratio to be estimated with at least 80% of study power and 95% precision for selected characteristics were calculated by comparing proportions in STATA (command \"sampsi\"). This was done assuming an estimate of asthma prevalence of 10% , signifiAsthma, rhinitis and eczema will be defined according to the International Study of Allergy and Asthma in Childhood (ISAAC) . Atopy wThe field work of the surveys in 2005 and 2008 involves 7 different activities, each conducted by different field teams and supervised by at least one of the co-investigators. Application of the main questionnaire, anthropometric survey, and stool and dust sample collection were completed in 2005. The activities were:1. Questionnaire: mostly based on the ISAAC Phase II questionnaire , transla2. An anthropometric survey with two independent measures of height and weight collected in a standardised way conducted by trained nutritionists, taking the mean value as the final measure, as recommended by WHO: z-scores for weight-for-age, weight-for-height and height-for-age were calculated using the EPINUT program  (details published elsewhere ).3. Stool samples collected for helminths and parasites with two different samples for each child, 2 days apart. Stools were analysed using the gravitational sedimentation technique of Hoffman, Pons & Janner to detect helminth eggs, protozoan cysts and oocysts. Two slides were examined for each stool sample. Quantification of helminth eggs was performed using the Kato-Katz technique . All chi2 area, adjacent to the head side. The filters were weighed before and after collection of the dust samples. Fibres and large particles were removed from the dust with forceps and the fine particulated dust samples were weighed, aliquotted as 100 mg samples and cryo-preserved at -20\u00b0C. Temperature and air humidity were recorded at the bedroom with a thermohygrometer .4. Dust samples collected using a residential vacuum cleaner  containing a nylon 25 um micromesh sock filter . The chiA. lumbricoides, T. trichura, Toxoplasma gondii and Toxocara canis, and (iii) cytokines IFN-gamma, IL-13 and IL-10 and TGF-\u03b2 in supernatant fluids collected from antigen-stimulated whole blood cultures.5. Blood samples: An aliquot of 10 mL collected to measure (i) total and allergen specific IgE , (ii) IgG antibodies to Hepatitis A virus, Herpes simplex, Herpes zoster, and Epstein-Barr viruses, Dermatophagoides pteronyssinus, Blomia tropicalis, Blattella germanica, Periplaneta americana, fungi, dog and cat epithelia. Saline and histamine was used as negative and positive controls, respectively. Wheal sizes will be read after 15 minutes and reactions will be considered positive if the mean of the two larger perpendicular diameters of the reaction is at least three millimeters superior to the mean of the two larger perpendicular diameters of the negative control reaction area.6. Skin prick test (SPT) carried out by allergen skin prick testing of the right forearm of each children using extracts  of 7. Skin inspection for flexural dermatitis performed by trained observers using the ISAAC phase II protocol  will comBlomia tropicalis Blo t 5, Dermatophagoides pteronyssinus Der p 1, Blatella germanica Bla g 2, Cat Fel d1, Dog Can f1Bacterial endotoxin and fungal b-glucan will be measured using the Limulus Amebocyte Lysate (LAL) assay (Cambrex Bio-Ci\u00eancia do Brasil Ltda) following the manufacturers' instructions.Aeroallergens will be quantified from dust samples by capture ELISA using commercially available kits  for the following aeroallergens: Ascaris lumbricoides (10 \u03bcg/ml); Blomia tropicalis (40 \u03bcg/ml); Dermatophagoides pteronyssinus (5 \u03bcg/ml). Pookweed mitogen  diluted at 1/1000 will be used as a positive control and media alone as negative control. House dust mites cultivated in fish food will be purified, lysed in pH 7.4 phosphate saline (PBS) with the use of a blender . The A. lumbricoides antigen will be obtained by trituration of liquid nitrogen frozen adult worms obtained from a child treated with albendazole, in a blender as stated above in the presence of PBS. After centrifugation, the supernatants will be cryopreserved for storage before use. All antigens will be depleted of endotoxin by treatment with triton-114  and the protein contents will be determined by the Lowry method. Whole blood cultures will be cultivated at 5% CO2, for 24 hours for detection of IL-10 and for 5 days for the detection of IL-13, TGF-\u03b2 and IFN-gamma. Cytokines in supernatant fluids will be measured using Pharmigen BD antibody pairs and recombinant standards  by capture ELISA following the manufacturer's instructions. Cytokines will be estimated by interpolation of standard curves of recombinant standards.Heparinised whole blood will be cultivated at a dilution at 1:4 in RPMI  containing 10 mM glutamine , 100 \u03bcg/ml of gentamicyn , and stimulated with the following antigens: Total IgE will be measured as follows: COSTAR high binding microassay plates  will be coated with 4 \u03bcg/ml of an anti- human -IgE antibody  overnight at 4C. Plates will be blocked with 0.15 M phosphate-buffered saline, pH 7.2 (PBS), containing 20% of dried skimmed milk (DSM) and 0.05% of Tween 20  overnight, at 4\u00b0C. Sera to be tested and IgE antibody standards . will be diluted 1:10 in PBS containing 10% of DSM and 0.05% of Tween 20 and incubated overnight at 4\u00b0C. A goat anti-human IgE-peroxidase conjugate , and an anti-goat immunoglobulin-peroxidase conjugate , will be diluted at 1:2000 and 1:10.000, respectively, and incubated for 60 minutes at room temperature. The results will be expressed in International Units (IU). A pool of parasite infected patients' sera will be used as positive control. Umbilical cord serum from a non-atopic and non-parasited mother will be used as negative control.Dermatophagoides pteronyssinus, Blomia tropicalis, Blatella germanica, dog and cat epithelia main allergens using the RAST system .Determination of specific IgE serum concentration will be done for A. lumbricoides IgG4 will be detected by an indirect ELISA using wells of high binding microassay plates , sensitized with 20 \u03bcg/ml, of the parasite antigen as stated above, diluted in carbonate-bicarbonate pH 9,6 buffer. The sera will be diluted at 1:50 in PBS containing 10% skimmed milk and 0,1 % tween 20 (PBS/SM/T). The reaction will be detected using a biotinylated anti-human-IgG4/, streptoavidin/peroxidase  and H2O2 e OPD . The assay cut-off will be the mean plus 3 SD of negative controls . Anti-Toxocara IgG antibodies will be detected using 20 \u03bcg/ml of larvae excretorial-secretorial antigen obtained by cultivation of the larva as described by De Savigny et al. [A. lumbricoides; the development of the reaction will be done as described for A. lumbricoides IgG4 except for the conjugate that will be a biotinylated anti-human IgG. The assay cut of will be the mean plus 3 SD of negative controls . Anti-Toxoplama gondii IgG and IgM will be detected using commercially available ELISA kits , following the manufacturer's instructions. IgG antibody against the following virus will measured: Herpes simplex, Herpes zoster, Epstein-Bahr and Hepatitis A virus. Detection will be done using commercially available ELISA kits , following the manufacturers' instructions.Detection of anti-parasite antibodies. Anti-y et al.  (The serData for study variables were collected either (i) during the 3 previous baseline surveys and that will be updated in the 2 forthcoming surveys (2005 and 2008), or (ii) are new data to be collected in these 2 forthcoming surveys. Table In the earlier cohorts no data was collected regarding asthma and hence incidence cannot be estimated in the first survey (2005). In the second survey (2008) a measure of incidence will be estimated reflecting new cases arising between 2005 and 2008. However, establishing asthma diagnosis in infancy is difficult. Additional information on occurrence of episodes of shortness of breath, fever and cough that are available for a year following the baseline surveys will also be used. This information may be more accurate than prevalence estimates estimated from data collected using a later questionnaire for asthma symptoms in infancy.Statistical analysis will be conducted according to a conceptual framework defining a proposed causal pathway. Bivariate association analysis will be carried out by calculating prevalence ratios and 95% confidence intervals to measure the strength of the association between each potential risk factor and the outcomes of interest. At his stage, the main outcomes of interest are atopy , asthma and allergy). Multivariate analysis will be taken out in several steps. First, within each level, multivariate data reduction techniques  will be applied to summarise highly correlated variables to index variables . Secondly, for each level, multivariate regression models will be fitted to estimate association parameters adjusted for confounding factors of the same level. In addition, multi-level modelling and robust variance estimation techniques will be used to adjust for intra-subject correlation due to repeated measures on the same individual and/or geographical areas. Finally, to address the complex inter-relationships between risk factors of different levels and outcomes according to our pre-defined conceptual framework, we will apply the following analysis strategies: i) A hierarchical effect decomposition strategy fitting a sequence of regression models each including different blocks of covariates, similar to an approach suggested by other authors ; ii) LogEthical approval was obtained from the Brazilian National Ethical Committee in 2004. Written informed consent was obtained from the legal guardian of each subject. It details all the procedures in the course of the project. All the clinical relevant results will be sent to the subjects parents, and specific recommendations will be done by a trained clinician after reviewing each case.The SCAALA programme that includes the Salvador and the Ecuador project, is expected to provide important new information and contribute to our understanding of why the prevalence of asthma and allergies appear to be so high in urban settings in LA. The two studies have different objectives and designs, but they have similar conceptual frameworks and share expertise and operational resources. These projects require extensive co-ordination, involve expertise from several different disciplines  and complex logistics . Study designs used include surveys and case-control studies making possible the comparison of prevalence and risk factors for asthma and other allergic diseases between urban and rural environments (the Ecuador study) and a longitudinal study of the effects of early life exposures of an urban population on asthma and other allergic diseases . The laboratory component will explore the relative importance of different immunological mechanisms in mediating the effects of environment exposures (with emphasis on helminths and other infectious diseases of childhood) on the risk of asthma and allergic diseases. Statistical analysis will involve the use of strategies that link data from different levels  and will use advanced statistical techniques to deal with this complex frameworkThe Salvador study is the continuation of three different cohorts initiated several years ago with objective of studying the effects in changes in sanitation on the risk of infectious diseases The earlier data collected for these cohort studies, therefore, will provide important information that will allow the study to examine the importance of the 'hygiene hypothesis' in determining allergy risk in an poor urban centre of LA Theses cohorts provide prospective data over a period of 12 months from between birth and 3 years of age. Data was collected through home visits every 2 on diarrhoea, reported fever, cough and shortness of breath. Demographic, socio-economic, sanitation-related environmental data was collected also. Each child was weighed, height was measured, and a stool sample was collected for parasitologic assessment. Second, although data was collected at the individual level, the use of \"sentinel areas\" throughout Salvador made possible the collection of community level aggregate data and or census dataIn summary, the proposed programme aims to clarify the social and biological mechanisms mediating the effect of population changes on the frequency of atopic disease in LA. Latin America is undergoing a rapid process of population change, including urbanization, migration, economic development and adoption of a \"modern\" lifestyle. Efforts to improve water supply, sanitation, rubbish collection and other hygienic measures are common to the different LA countries. It is expected that knowledge generated may thus help identify public health interventions that may enable countries In LA to enjoy the benefits of a \"modern\" lifestyle while avoiding \u2013 or minimising \u2013 increases in morbidity caused by asthma and allergies.ISAAC: International Study of Asthma and Allergies in ChildhoodSCAALA: Social Change, Allergy and Asthma in Latin AmericaThe author(s) declare that they have no competing interests.MLB conceived of the study, and participated in its design and coordination and lead the drafting of the manuscript, SSC participated in the design, coordinated the study, participate on the plan of analysis and helped draft this manuscript; NAN carried out the stool sample studies and the allergens studies; LPC carried out the immunological studies; AAC carried out all clinical investiagtion, RTS participated inthe drafting on the manuscript; BG lead the development of plan of analysis, PJC participated in the conception of the study design and plan of analysis, LCR conceived of the study, participated in its design and plan of analysis and helped to draft the manuscript. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:", "texts": ["The prevalence of asthma and allergic diseases has increased in industrialised countries, and it is known that rates vary according whether the area is urban or rural and to socio-economic status. Surveys conducted in some urban settings in Latin America found high prevalence rates, only exceeded by the rates observed in industrialised English-speaking countries. It is likely that the marked changes in the environment, life style and living conditions in Latin America are responsible for these observations. The understanding of the epidemiological and immunological changes that underlie the increase in asthma and allergic diseases in Latin America aimed by SCAALA studies in Brazil and Ecuador will be crucial for the identification of novel preventive interventions.The Salvador-SCAALA project described here is a longitudinal study involving children aged 4\u201311 years living in the city of Salvador, Northeastern Brazil. Data on asthma and allergic diseases (rhinitis and eczema) and potential risk factors will be collected in successive surveys using standardised questionnaire. This will be completed with data on dust collection (to dust mite and endotoxin), skin test to most common allergens, stool examinations to helminth and parasites, blood samples , formaldehyde, physical inspection to diagnoses of eczema, and anthropometric measures. Data on earlier exposures when these children were 0\u20133 years old are available from a different project.It is expected that knowledge generated may help identify public health interventions that may enable countries in LA to enjoy the benefits of a \"modern\" lifestyle while avoiding \u2013 or minimising \u2013 increases in morbidity caused by asthma and allergies. The prevalence of asthma and allergic diseases (rhinitis and eczema) has increased in industrialised countries in the last 2 decades -3; in thAmong environmental exposures that may have contributed to the trends in allergy prevalence, those that have attracted most interest are the fall in exposures to infectious diseases. The so-called \"hygiene hypothesis\" proposed that increases in the prevalence of allergic diseases were explained by improvements in living conditions, use of antibiotics and childhood vaccinations leading to a reduction in exposure to infections in early life . DiffereWhatever the mechanisms involved the strong evidence that the temporal allergy trends are related to changes in lifestyle and living conditions raises the possibility that preventive interventions against allergic diseases can be identified. The understanding of the epidemiological and immunological changes that underlie the increase in asthma and allergic diseases will be crucial for the identification of novel preventive interventions.International studies of the asthma prevalence have been conducted with the International Study of Asthma and Allergies in Childhood (ISAAC) study group using a standardised written questionnaire for self-reported asthma and respiratory symptoms. In these surveys, some Latin American settings  had very high prevalence rates, that were exceeded only by industrialised English-speaking countries . These rThe study described here is part of a larger ongoing research programme being conducted in Brazil  and Ecuador. Populations in both countries have experienced recent changes in living conditions and life style . This research programme is funded by The Wellcome Trust through the programme of Major Awards to Centres of Excellence in Latin America and has adopted the name SCAALA . This paper specifically deals with the methodological aspects of the cohort study being conducted in Salvador, Brazil.The Salvador cohort study has two main objectives. Firstly, to investigate the associations between the prevalence of asthma and other allergic diseases  and potential risk factors that includes living conditions and early life and current exposures to infections, and secondly, to investigate how the association between environment factors, allergic diseases and markers of atopy  are mediated by serum interleukins. In contrast, the study in Ecuador aims to study frequency of atopy and allergic diseases and exposure to potential risk factor in rural populations and in migrants from rural to urban areas; and examine how these may explain the risk of atopic diseases in migrants from rural to urban areas. This study will be described in a separate paper.Salvador, the capital of the State of Bahia, in the Northeast Brazil has approximately 2.5 million inhabitants, and is located in the poorest region in the country. Over 80% of the population is black or mixed-race (mulatto). There is a high degree of social inequality: GINI coefficient was 0.66 in 2000 . The citChildren in this research project have been part of a study conducted earlier to evaluate the impact of the sanitation programme on the occurrence of childhood diarrhoea. This first study was originally designed to enrol three separate cohorts of children aged 0\u20133 years recruited from 24 small geographical areas selected to represent the population without sanitation in Salvador, called sentinel-areas ,17 TheseTo take advantage of these three cohorts , the children who were aged 4\u201311 years and had complete follow-up information (e.g. stool examination conducted at 3 different time points) were selected for the present study.Follow-up during the current study on asthma and allergic diseases consists of two additional surveys to be conducted between 2005 and 2006, and again in 2008. The two surveys will assess children from the three previous cohort studies and will: (i) update information collected in the baseline surveys (ii) collect information on additional risk factors, (iii) collect stool samples for diagnosis of intestinal parasitic infections, (iv) collect blood samples for immunological analysis, (v) collect dust to measure allergen exposure, (vi) collect data on formaldehyde and particulate levels indoors and outdoors and (vii) collect data on asthma and allergic diseases . The information collected during previous surveys and follow-up will be used in the present study to investigate early risk factors relating to infectious disease exposures and living conditions of the children from birth. All children from the previous 3 cohort studies were eligible to enter the present study.The total number of children recruited in the first resurvey with questionnaires completed was 1,445. Given this total number of children recruited, the magnitude of the prevalence rate ratio to be estimated with at least 80% of study power and 95% precision for selected characteristics were calculated by comparing proportions in STATA (command \"sampsi\"). This was done assuming an estimate of asthma prevalence of 10% , signifiAsthma, rhinitis and eczema will be defined according to the International Study of Allergy and Asthma in Childhood (ISAAC) . Atopy wThe field work of the surveys in 2005 and 2008 involves 7 different activities, each conducted by different field teams and supervised by at least one of the co-investigators. Application of the main questionnaire, anthropometric survey, and stool and dust sample collection were completed in 2005. The activities were:1. Questionnaire: mostly based on the ISAAC Phase II questionnaire , transla2. An anthropometric survey with two independent measures of height and weight collected in a standardised way conducted by trained nutritionists, taking the mean value as the final measure, as recommended by WHO: z-scores for weight-for-age, weight-for-height and height-for-age were calculated using the EPINUT program  (details published elsewhere ).3. Stool samples collected for helminths and parasites with two different samples for each child, 2 days apart. Stools were analysed using the gravitational sedimentation technique of Hoffman, Pons & Janner to detect helminth eggs, protozoan cysts and oocysts. Two slides were examined for each stool sample. Quantification of helminth eggs was performed using the Kato-Katz technique . All chi2 area, adjacent to the head side. The filters were weighed before and after collection of the dust samples. Fibres and large particles were removed from the dust with forceps and the fine particulated dust samples were weighed, aliquotted as 100 mg samples and cryo-preserved at -20\u00b0C. Temperature and air humidity were recorded at the bedroom with a thermohygrometer .4. Dust samples collected using a residential vacuum cleaner  containing a nylon 25 um micromesh sock filter . The chiA. lumbricoides, T. trichura, Toxoplasma gondii and Toxocara canis, and (iii) cytokines IFN-gamma, IL-13 and IL-10 and TGF-\u03b2 in supernatant fluids collected from antigen-stimulated whole blood cultures.5. Blood samples: An aliquot of 10 mL collected to measure (i) total and allergen specific IgE , (ii) IgG antibodies to Hepatitis A virus, Herpes simplex, Herpes zoster, and Epstein-Barr viruses, Dermatophagoides pteronyssinus, Blomia tropicalis, Blattella germanica, Periplaneta americana, fungi, dog and cat epithelia. Saline and histamine was used as negative and positive controls, respectively. Wheal sizes will be read after 15 minutes and reactions will be considered positive if the mean of the two larger perpendicular diameters of the reaction is at least three millimeters superior to the mean of the two larger perpendicular diameters of the negative control reaction area.6. Skin prick test (SPT) carried out by allergen skin prick testing of the right forearm of each children using extracts  of 7. Skin inspection for flexural dermatitis performed by trained observers using the ISAAC phase II protocol  will comBlomia tropicalis Blo t 5, Dermatophagoides pteronyssinus Der p 1, Blatella germanica Bla g 2, Cat Fel d1, Dog Can f1Bacterial endotoxin and fungal b-glucan will be measured using the Limulus Amebocyte Lysate (LAL) assay (Cambrex Bio-Ci\u00eancia do Brasil Ltda) following the manufacturers' instructions.Aeroallergens will be quantified from dust samples by capture ELISA using commercially available kits  for the following aeroallergens: Ascaris lumbricoides (10 \u03bcg/ml); Blomia tropicalis (40 \u03bcg/ml); Dermatophagoides pteronyssinus (5 \u03bcg/ml). Pookweed mitogen  diluted at 1/1000 will be used as a positive control and media alone as negative control. House dust mites cultivated in fish food will be purified, lysed in pH 7.4 phosphate saline (PBS) with the use of a blender . The A. lumbricoides antigen will be obtained by trituration of liquid nitrogen frozen adult worms obtained from a child treated with albendazole, in a blender as stated above in the presence of PBS. After centrifugation, the supernatants will be cryopreserved for storage before use. All antigens will be depleted of endotoxin by treatment with triton-114  and the protein contents will be determined by the Lowry method. Whole blood cultures will be cultivated at 5% CO2, for 24 hours for detection of IL-10 and for 5 days for the detection of IL-13, TGF-\u03b2 and IFN-gamma. Cytokines in supernatant fluids will be measured using Pharmigen BD antibody pairs and recombinant standards  by capture ELISA following the manufacturer's instructions. Cytokines will be estimated by interpolation of standard curves of recombinant standards.Heparinised whole blood will be cultivated at a dilution at 1:4 in RPMI  containing 10 mM glutamine , 100 \u03bcg/ml of gentamicyn , and stimulated with the following antigens: Total IgE will be measured as follows: COSTAR high binding microassay plates  will be coated with 4 \u03bcg/ml of an anti- human -IgE antibody  overnight at 4C. Plates will be blocked with 0.15 M phosphate-buffered saline, pH 7.2 (PBS), containing 20% of dried skimmed milk (DSM) and 0.05% of Tween 20  overnight, at 4\u00b0C. Sera to be tested and IgE antibody standards . will be diluted 1:10 in PBS containing 10% of DSM and 0.05% of Tween 20 and incubated overnight at 4\u00b0C. A goat anti-human IgE-peroxidase conjugate , and an anti-goat immunoglobulin-peroxidase conjugate , will be diluted at 1:2000 and 1:10.000, respectively, and incubated for 60 minutes at room temperature. The results will be expressed in International Units (IU). A pool of parasite infected patients' sera will be used as positive control. Umbilical cord serum from a non-atopic and non-parasited mother will be used as negative control.Dermatophagoides pteronyssinus, Blomia tropicalis, Blatella germanica, dog and cat epithelia main allergens using the RAST system .Determination of specific IgE serum concentration will be done for A. lumbricoides IgG4 will be detected by an indirect ELISA using wells of high binding microassay plates , sensitized with 20 \u03bcg/ml, of the parasite antigen as stated above, diluted in carbonate-bicarbonate pH 9,6 buffer. The sera will be diluted at 1:50 in PBS containing 10% skimmed milk and 0,1 % tween 20 (PBS/SM/T). The reaction will be detected using a biotinylated anti-human-IgG4/, streptoavidin/peroxidase  and H2O2 e OPD . The assay cut-off will be the mean plus 3 SD of negative controls . Anti-Toxocara IgG antibodies will be detected using 20 \u03bcg/ml of larvae excretorial-secretorial antigen obtained by cultivation of the larva as described by De Savigny et al. [A. lumbricoides; the development of the reaction will be done as described for A. lumbricoides IgG4 except for the conjugate that will be a biotinylated anti-human IgG. The assay cut of will be the mean plus 3 SD of negative controls . Anti-Toxoplama gondii IgG and IgM will be detected using commercially available ELISA kits , following the manufacturer's instructions. IgG antibody against the following virus will measured: Herpes simplex, Herpes zoster, Epstein-Bahr and Hepatitis A virus. Detection will be done using commercially available ELISA kits , following the manufacturers' instructions.Detection of anti-parasite antibodies. Anti-y et al.  (The serData for study variables were collected either (i) during the 3 previous baseline surveys and that will be updated in the 2 forthcoming surveys (2005 and 2008), or (ii) are new data to be collected in these 2 forthcoming surveys. Table In the earlier cohorts no data was collected regarding asthma and hence incidence cannot be estimated in the first survey (2005). In the second survey (2008) a measure of incidence will be estimated reflecting new cases arising between 2005 and 2008. However, establishing asthma diagnosis in infancy is difficult. Additional information on occurrence of episodes of shortness of breath, fever and cough that are available for a year following the baseline surveys will also be used. This information may be more accurate than prevalence estimates estimated from data collected using a later questionnaire for asthma symptoms in infancy.Statistical analysis will be conducted according to a conceptual framework defining a proposed causal pathway. Bivariate association analysis will be carried out by calculating prevalence ratios and 95% confidence intervals to measure the strength of the association between each potential risk factor and the outcomes of interest. At his stage, the main outcomes of interest are atopy , asthma and allergy). Multivariate analysis will be taken out in several steps. First, within each level, multivariate data reduction techniques  will be applied to summarise highly correlated variables to index variables . Secondly, for each level, multivariate regression models will be fitted to estimate association parameters adjusted for confounding factors of the same level. In addition, multi-level modelling and robust variance estimation techniques will be used to adjust for intra-subject correlation due to repeated measures on the same individual and/or geographical areas. Finally, to address the complex inter-relationships between risk factors of different levels and outcomes according to our pre-defined conceptual framework, we will apply the following analysis strategies: i) A hierarchical effect decomposition strategy fitting a sequence of regression models each including different blocks of covariates, similar to an approach suggested by other authors ; ii) LogEthical approval was obtained from the Brazilian National Ethical Committee in 2004. Written informed consent was obtained from the legal guardian of each subject. It details all the procedures in the course of the project. All the clinical relevant results will be sent to the subjects parents, and specific recommendations will be done by a trained clinician after reviewing each case.The SCAALA programme that includes the Salvador and the Ecuador project, is expected to provide important new information and contribute to our understanding of why the prevalence of asthma and allergies appear to be so high in urban settings in LA. The two studies have different objectives and designs, but they have similar conceptual frameworks and share expertise and operational resources. These projects require extensive co-ordination, involve expertise from several different disciplines  and complex logistics . Study designs used include surveys and case-control studies making possible the comparison of prevalence and risk factors for asthma and other allergic diseases between urban and rural environments (the Ecuador study) and a longitudinal study of the effects of early life exposures of an urban population on asthma and other allergic diseases . The laboratory component will explore the relative importance of different immunological mechanisms in mediating the effects of environment exposures (with emphasis on helminths and other infectious diseases of childhood) on the risk of asthma and allergic diseases. Statistical analysis will involve the use of strategies that link data from different levels  and will use advanced statistical techniques to deal with this complex frameworkThe Salvador study is the continuation of three different cohorts initiated several years ago with objective of studying the effects in changes in sanitation on the risk of infectious diseases The earlier data collected for these cohort studies, therefore, will provide important information that will allow the study to examine the importance of the 'hygiene hypothesis' in determining allergy risk in an poor urban centre of LA Theses cohorts provide prospective data over a period of 12 months from between birth and 3 years of age. Data was collected through home visits every 2 on diarrhoea, reported fever, cough and shortness of breath. Demographic, socio-economic, sanitation-related environmental data was collected also. Each child was weighed, height was measured, and a stool sample was collected for parasitologic assessment. Second, although data was collected at the individual level, the use of \"sentinel areas\" throughout Salvador made possible the collection of community level aggregate data and or census dataIn summary, the proposed programme aims to clarify the social and biological mechanisms mediating the effect of population changes on the frequency of atopic disease in LA. Latin America is undergoing a rapid process of population change, including urbanization, migration, economic development and adoption of a \"modern\" lifestyle. Efforts to improve water supply, sanitation, rubbish collection and other hygienic measures are common to the different LA countries. It is expected that knowledge generated may thus help identify public health interventions that may enable countries In LA to enjoy the benefits of a \"modern\" lifestyle while avoiding \u2013 or minimising \u2013 increases in morbidity caused by asthma and allergies.ISAAC: International Study of Asthma and Allergies in ChildhoodSCAALA: Social Change, Allergy and Asthma in Latin AmericaThe author(s) declare that they have no competing interests.MLB conceived of the study, and participated in its design and coordination and lead the drafting of the manuscript, SSC participated in the design, coordinated the study, participate on the plan of analysis and helped draft this manuscript; NAN carried out the stool sample studies and the allergens studies; LPC carried out the immunological studies; AAC carried out all clinical investiagtion, RTS participated inthe drafting on the manuscript; BG lead the development of plan of analysis, PJC participated in the conception of the study design and plan of analysis, LCR conceived of the study, participated in its design and plan of analysis and helped to draft the manuscript. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:"]}
{"representative": "Eating patterns in Western industrialized countries are characterized by a high energy intake and an overconsumption of (saturated) fat, cholesterol, sugar and salt. Many chronic diseases are associated with unhealthy eating patterns. On the other hand, a healthy diet (low saturated fat intake and high fruit and vegetable intake) has been found important in the prevention of health problems, such as cancer and cardio-vascular disease (CVD). The worksite seems an ideal intervention setting to influence dietary behavior. The purpose of this study is to present the effects of a worksite environmental intervention on fruit, vegetable and fat intake and determinants of behavior.A controlled trial that included two different governmental companies (n = 515): one intervention and one control company. Outcome measurements (short-fat list and fruit and vegetable questionnaire) took place at baseline and 3 and 12 months after baseline. The relatively modest environmental intervention consisted of product information to facilitate healthier food choices  value of foods in groups of products was translated into the number of minutes to perform a certain  activity to burn these calories).Significant changes in psychosocial determinants of dietary behavior were found; subjects at the intervention worksite perceived more social support from their colleagues in eating less fat. But also counter intuitive effects were found: at 12 months the attitude and self-efficacy towards eating less fat became less positive in the intervention group. No effects were found on self-reported fat, fruit and vegetable intake.This environmental intervention was modestly effective in changing behavioral determinant towards eating less fat , but ineffective in positively changing actual fat, fruit and vegetable intake of office workers. Lifestyles in Western industrialized countries are characterized by a decreasing level of physical activity -3, a higA healthy diet  has also been found important in the prevention of health problems, such as some types of cancer and cardiovascular disease (CVD) -8. MoreoWorksites are an effective channel to promote healthy food habits among employees by means of comprehensive worksite health promotion programs (WHPP's), because they provide access to a large proportion of the adult population and people spend a great deal of their time at the worksite. In many WHPP's, traditional methods  to increase knowledge and skills are used to stimulate healthy behavior -13. HoweTherefore, a worksite intervention (i.e. FoodSteps) solely consisting of relatively modest environmental changes was developed to stimulate physical activity, but also healthy food habits of office-workers. The purpose of this study is to present the effects of this intervention on determinants of dietary behavior and on self-reported fat, fruit and vegetable intake.2) in women and a BMI \u2264 23 (kg/m2) in men. In order to select a population at higher risk for disease associated with overweight, the inclusion criterion of a BMI \u2264 23 was applied in our study. Subjects who were pregnant or became pregnant during intervention year, or had severe cardiovascular/musculoskeletal disorders were excluded. Employees received a leaflet by company internal mail system in which they were asked to participate in the study and they had to return a written reply form to be included in the study. On the reply form a number of screening questions (including self-reported body weight and body height) had to be filled out. A written informed consent was obtained from the subjects and this study had the approval from the medical ethics committee of the VU University Medical Center.In this controlled longitudinal trial, two different government companies in The Hague (the Netherlands) were used: one intervention and one control company. These worksites were chosen because of the similar job-descriptions of the employees. The inclusion criteria for participating in the study were; (1) office worker, (2) the ability to climb the stairs, (3) a body mass index (BMI) \u2264 23 and (4) a contract for at least the duration of the intervention. In a review on the public health burden of obesity of Visscher et al , a numbeThe questionnaires were distributed among subjects at both worksites at baseline (October 2003), at three months (April 2004) and 12 months (November 2004).The FoodSteps intervention consisted of two parts, one part focusing on food  and one on physical activity . The food-intervention took place over 12 months (January 2004\u2013December 2004) in the company canteen of the intervention company and mostly consisted of placing informational sheets near food products, to stimulate healthier food choices. Every four weeks one group out of six groups of products was chosen to be highlighted. Each group was repeated once during the year. On the informational sheets the caloric  value of a product was translated into the number of minutes to perform a certain  activity . The product-groups were: (1) dairy products  (2) warm snacks, (3) fruit-vegetables-salads, (4) cold ready-to-eat sandwiches (including fillings) (5) sandwich fillings  and (6) pastry. On three vending machines similar information sheets were placed, on which the snacks  offered in the machines were highlighted. The sheets on the vending machines were not changed during the intervention year. Additionally, an information stand was placed in the canteen with brochures and leaflets on healthy food, blood pressure and cholesterol. Finally, every two months during one day a week a buffet with healthy products was offered to the customers of the company canteen.Psychosocial determinants of eating more fruit, vegetables and less fat were measured applying the 'attitude-social influence- (self-)efficacy model' (ASE model) ,22. All The validated Short Fruit and Vegetable questionnaire was used to measure fruit and vegetable consumption. This questionnaire consists of 10 questions: 6 about fruit consumption and 4 about vegetable consumption . SubjectIn this study the validated Fat list  was used2).The following data were collected by questionnaire: the highest achieved level of education, age, smoking (yes/no), number of alcoholic units per week, hours per week at the office, whether or not following a diet, whether or not being a regular visitor of the company canteen (at least once week purchasing food in the canteen) and whether or not taking lunch to work every day of the week. Additionally, as a part of the study, subjects were invited to attend a physical examination at all follow-ups where among other variables, body height (cm) and body weight (kg) were measured with subjects in underwear. The Body Mass Index (BMI) as measured at baseline was also used as a covariate in this study. BMI was calculated by dividing body weight (kg) by body height (m) squared (= kg/mBoth the short-term (3 months) and the long-term (12 months) effect of the intervention were analyzed by multivariate linear regression analysis. In this analysis the outcome at respectively 3 and 12 months was corrected for the baseline value. The regression-coefficient of the group allocation  variable reflects, the difference in change over time between worksites in the outcome variable. Linear regression analysis excludes subjects with missing data. Only subjects with baseline data and data on at least one follow-up were included in the analysis. Baseline values that differed (according to independent t-test) between intervention and control subjects at baseline, as well as a set of predefined variables  were checked as possible confounders. As possible effect modifiers were considered baseline data on: gender, BMI, whether or not taking lunch to work, being a regular visitor of the company canteen, smoking and alcoholic intake. Effect modification was defined as a significant (p < 0.10) interaction term between the group allocation variable and the variable of interest.In figure Although, a higher number of included subjects (about 900) was intended, with a power of 0,8 en alpha of 0,05, a difference of about a half (0.42) piece of fruit and 20.7 grams of vegetables can still be demonstrated with a total number of 515 participants.Questionnaire return-rates in the intervention site were 88.9% and 78.3% and in the control site 90.4% and 88.9%, at 3 and 12 months respectively. The baseline demographics of the total population are described in Table Table In addition, a significant negative interaction was found with BMI at baseline. This can be interpreted as an increasing intervention effect regarding the attitude to eat less fat at work for subjects with a higher BMI at baseline. No significant effects on any of the other psychosocial determinants were found.Table In Table The purpose of this study was to analyze the effects of a worksite environmental intervention on determinants of dietary behavior regarding eating more fruit and vegetables and eating less fat and on actual (self-reported) fat, fruit and vegetable intake.The results of this controlled trial showed that this environmental intervention only had a modest effect on determinants of dietary behavior. A significant effect was found on the perceived social support from colleagues regarding eating less fat. This determinant significantly increased at the short-term and borderline significant at long-term. However, also counterintuitive effects were found. First, at 12 months the attitude toward eating less fat decreased in the intervention group and decreased even more for subjects with a higher BMI at baseline. Second, self-efficacy towards eating less fat at work decreased significantly in the intervention group. The intervention was ineffective in significantly increasing fruit, vegetable intake and decreasing fat intake of the intervention group. An interesting finding was, however, that in the intervention group at short term the subgroup of workers who did not take their lunch to work every day significantly increased their fat intake compared to those in the control group.Just as in our study, in a controlled trial of Steenhuis et al  a similaOther worksite health promotion programs (WHPP's) did show positive results on self-reported fruit-vegetable and fat intake. These trials -29 were This difference in study population is an important point that might explain our poor results. In our study a primarily white-collar and highly educated population participated. White-collar populations are known to have in general more favorable food patterns (i.e. they eat more fruit-vegetables and less fat)  ThereforAnother explanation for the lack of positive results could be that in our study the same questionnaires as in the study of Steenhuis et al  were useA weak point in this study was that a relatively large proportion of the study population was not a regular visitor to the company canteen (about 40%). Because of this, the food intervention did not have the full impact it could have had. However, at follow-up no interaction was found between whether or not being a regular visitor to the canteen, and fruit-vegetable and fat intake. Also, the food intervention might have been too modest to sort any effect. As mentioned in the method section, only one product group at the time was highlighted by means of larger information sheets near the products included in the selected group. No information was put directly on the products and no clear-cut distinction between healthy or unhealthy products was made (for instance labeling products with either red or green colors), like in a study of Larsson et al . LarssonA limitation of this study might be the fact that no randomization was performed. Bias introduced by possible differences between worksites, might have been prevented if a randomization at the level of the individual could have been performed. However, due to the nature of the intervention this kind of randomization was not possible. Moreover, the main reason for not performing randomization at the level of the worksite was that, at the moment that the FoodSteps research proposal was approved, one worksite had already agreed to participate. In order to speed up the preparations of the intervention, this worksite was chosen as the intervention worksite. During this preparation period the control worksite still had to be found.In conclusion, this relatively modest environmental intervention was effective in significantly changing behavioral determinants towards eating less fat , but ineffective in significantly changing actual fat, fruit and vegetable intake of office workers. Negative changes in attitude and self-efficacy towards eating less fat at work were found. In future research it needs to be investigated if the food habits of employees can be changed by a more intensive environmental intervention.The author(s) declare that they have no competing interests.WVM is primary responsible for the study as presented in this paper. He made a significant intellectual contribution to the manuscript and has been involved in drafting and revising the manuscript critically.LE is the executive researcher of the FoodSteps project as presented in this article. He was responsible for preparing and implementing the intervention, collecting and analysing the data and writing of the manuscript.MVP made substantial contribution to the conception and the design of the study. In addition, MVP has been involved in drafting and revising the manuscript critically.MCAP made a substantial contribution to the conception and the design of the study, analysing the data, drafting and revising the manuscript critically.All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:", "texts": ["Eating patterns in Western industrialized countries are characterized by a high energy intake and an overconsumption of (saturated) fat, cholesterol, sugar and salt. Many chronic diseases are associated with unhealthy eating patterns. On the other hand, a healthy diet (low saturated fat intake and high fruit and vegetable intake) has been found important in the prevention of health problems, such as cancer and cardio-vascular disease (CVD). The worksite seems an ideal intervention setting to influence dietary behavior. The purpose of this study is to present the effects of a worksite environmental intervention on fruit, vegetable and fat intake and determinants of behavior.A controlled trial that included two different governmental companies (n = 515): one intervention and one control company. Outcome measurements (short-fat list and fruit and vegetable questionnaire) took place at baseline and 3 and 12 months after baseline. The relatively modest environmental intervention consisted of product information to facilitate healthier food choices  value of foods in groups of products was translated into the number of minutes to perform a certain  activity to burn these calories).Significant changes in psychosocial determinants of dietary behavior were found; subjects at the intervention worksite perceived more social support from their colleagues in eating less fat. But also counter intuitive effects were found: at 12 months the attitude and self-efficacy towards eating less fat became less positive in the intervention group. No effects were found on self-reported fat, fruit and vegetable intake.This environmental intervention was modestly effective in changing behavioral determinant towards eating less fat , but ineffective in positively changing actual fat, fruit and vegetable intake of office workers. Lifestyles in Western industrialized countries are characterized by a decreasing level of physical activity -3, a higA healthy diet  has also been found important in the prevention of health problems, such as some types of cancer and cardiovascular disease (CVD) -8. MoreoWorksites are an effective channel to promote healthy food habits among employees by means of comprehensive worksite health promotion programs (WHPP's), because they provide access to a large proportion of the adult population and people spend a great deal of their time at the worksite. In many WHPP's, traditional methods  to increase knowledge and skills are used to stimulate healthy behavior -13. HoweTherefore, a worksite intervention (i.e. FoodSteps) solely consisting of relatively modest environmental changes was developed to stimulate physical activity, but also healthy food habits of office-workers. The purpose of this study is to present the effects of this intervention on determinants of dietary behavior and on self-reported fat, fruit and vegetable intake.2) in women and a BMI \u2264 23 (kg/m2) in men. In order to select a population at higher risk for disease associated with overweight, the inclusion criterion of a BMI \u2264 23 was applied in our study. Subjects who were pregnant or became pregnant during intervention year, or had severe cardiovascular/musculoskeletal disorders were excluded. Employees received a leaflet by company internal mail system in which they were asked to participate in the study and they had to return a written reply form to be included in the study. On the reply form a number of screening questions (including self-reported body weight and body height) had to be filled out. A written informed consent was obtained from the subjects and this study had the approval from the medical ethics committee of the VU University Medical Center.In this controlled longitudinal trial, two different government companies in The Hague (the Netherlands) were used: one intervention and one control company. These worksites were chosen because of the similar job-descriptions of the employees. The inclusion criteria for participating in the study were; (1) office worker, (2) the ability to climb the stairs, (3) a body mass index (BMI) \u2264 23 and (4) a contract for at least the duration of the intervention. In a review on the public health burden of obesity of Visscher et al , a numbeThe questionnaires were distributed among subjects at both worksites at baseline (October 2003), at three months (April 2004) and 12 months (November 2004).The FoodSteps intervention consisted of two parts, one part focusing on food  and one on physical activity . The food-intervention took place over 12 months (January 2004\u2013December 2004) in the company canteen of the intervention company and mostly consisted of placing informational sheets near food products, to stimulate healthier food choices. Every four weeks one group out of six groups of products was chosen to be highlighted. Each group was repeated once during the year. On the informational sheets the caloric  value of a product was translated into the number of minutes to perform a certain  activity . The product-groups were: (1) dairy products  (2) warm snacks, (3) fruit-vegetables-salads, (4) cold ready-to-eat sandwiches (including fillings) (5) sandwich fillings  and (6) pastry. On three vending machines similar information sheets were placed, on which the snacks  offered in the machines were highlighted. The sheets on the vending machines were not changed during the intervention year. Additionally, an information stand was placed in the canteen with brochures and leaflets on healthy food, blood pressure and cholesterol. Finally, every two months during one day a week a buffet with healthy products was offered to the customers of the company canteen.Psychosocial determinants of eating more fruit, vegetables and less fat were measured applying the 'attitude-social influence- (self-)efficacy model' (ASE model) ,22. All The validated Short Fruit and Vegetable questionnaire was used to measure fruit and vegetable consumption. This questionnaire consists of 10 questions: 6 about fruit consumption and 4 about vegetable consumption . SubjectIn this study the validated Fat list  was used2).The following data were collected by questionnaire: the highest achieved level of education, age, smoking (yes/no), number of alcoholic units per week, hours per week at the office, whether or not following a diet, whether or not being a regular visitor of the company canteen (at least once week purchasing food in the canteen) and whether or not taking lunch to work every day of the week. Additionally, as a part of the study, subjects were invited to attend a physical examination at all follow-ups where among other variables, body height (cm) and body weight (kg) were measured with subjects in underwear. The Body Mass Index (BMI) as measured at baseline was also used as a covariate in this study. BMI was calculated by dividing body weight (kg) by body height (m) squared (= kg/mBoth the short-term (3 months) and the long-term (12 months) effect of the intervention were analyzed by multivariate linear regression analysis. In this analysis the outcome at respectively 3 and 12 months was corrected for the baseline value. The regression-coefficient of the group allocation  variable reflects, the difference in change over time between worksites in the outcome variable. Linear regression analysis excludes subjects with missing data. Only subjects with baseline data and data on at least one follow-up were included in the analysis. Baseline values that differed (according to independent t-test) between intervention and control subjects at baseline, as well as a set of predefined variables  were checked as possible confounders. As possible effect modifiers were considered baseline data on: gender, BMI, whether or not taking lunch to work, being a regular visitor of the company canteen, smoking and alcoholic intake. Effect modification was defined as a significant (p < 0.10) interaction term between the group allocation variable and the variable of interest.In figure Although, a higher number of included subjects (about 900) was intended, with a power of 0,8 en alpha of 0,05, a difference of about a half (0.42) piece of fruit and 20.7 grams of vegetables can still be demonstrated with a total number of 515 participants.Questionnaire return-rates in the intervention site were 88.9% and 78.3% and in the control site 90.4% and 88.9%, at 3 and 12 months respectively. The baseline demographics of the total population are described in Table Table In addition, a significant negative interaction was found with BMI at baseline. This can be interpreted as an increasing intervention effect regarding the attitude to eat less fat at work for subjects with a higher BMI at baseline. No significant effects on any of the other psychosocial determinants were found.Table In Table The purpose of this study was to analyze the effects of a worksite environmental intervention on determinants of dietary behavior regarding eating more fruit and vegetables and eating less fat and on actual (self-reported) fat, fruit and vegetable intake.The results of this controlled trial showed that this environmental intervention only had a modest effect on determinants of dietary behavior. A significant effect was found on the perceived social support from colleagues regarding eating less fat. This determinant significantly increased at the short-term and borderline significant at long-term. However, also counterintuitive effects were found. First, at 12 months the attitude toward eating less fat decreased in the intervention group and decreased even more for subjects with a higher BMI at baseline. Second, self-efficacy towards eating less fat at work decreased significantly in the intervention group. The intervention was ineffective in significantly increasing fruit, vegetable intake and decreasing fat intake of the intervention group. An interesting finding was, however, that in the intervention group at short term the subgroup of workers who did not take their lunch to work every day significantly increased their fat intake compared to those in the control group.Just as in our study, in a controlled trial of Steenhuis et al  a similaOther worksite health promotion programs (WHPP's) did show positive results on self-reported fruit-vegetable and fat intake. These trials -29 were This difference in study population is an important point that might explain our poor results. In our study a primarily white-collar and highly educated population participated. White-collar populations are known to have in general more favorable food patterns (i.e. they eat more fruit-vegetables and less fat)  ThereforAnother explanation for the lack of positive results could be that in our study the same questionnaires as in the study of Steenhuis et al  were useA weak point in this study was that a relatively large proportion of the study population was not a regular visitor to the company canteen (about 40%). Because of this, the food intervention did not have the full impact it could have had. However, at follow-up no interaction was found between whether or not being a regular visitor to the canteen, and fruit-vegetable and fat intake. Also, the food intervention might have been too modest to sort any effect. As mentioned in the method section, only one product group at the time was highlighted by means of larger information sheets near the products included in the selected group. No information was put directly on the products and no clear-cut distinction between healthy or unhealthy products was made (for instance labeling products with either red or green colors), like in a study of Larsson et al . LarssonA limitation of this study might be the fact that no randomization was performed. Bias introduced by possible differences between worksites, might have been prevented if a randomization at the level of the individual could have been performed. However, due to the nature of the intervention this kind of randomization was not possible. Moreover, the main reason for not performing randomization at the level of the worksite was that, at the moment that the FoodSteps research proposal was approved, one worksite had already agreed to participate. In order to speed up the preparations of the intervention, this worksite was chosen as the intervention worksite. During this preparation period the control worksite still had to be found.In conclusion, this relatively modest environmental intervention was effective in significantly changing behavioral determinants towards eating less fat , but ineffective in significantly changing actual fat, fruit and vegetable intake of office workers. Negative changes in attitude and self-efficacy towards eating less fat at work were found. In future research it needs to be investigated if the food habits of employees can be changed by a more intensive environmental intervention.The author(s) declare that they have no competing interests.WVM is primary responsible for the study as presented in this paper. He made a significant intellectual contribution to the manuscript and has been involved in drafting and revising the manuscript critically.LE is the executive researcher of the FoodSteps project as presented in this article. He was responsible for preparing and implementing the intervention, collecting and analysing the data and writing of the manuscript.MVP made substantial contribution to the conception and the design of the study. In addition, MVP has been involved in drafting and revising the manuscript critically.MCAP made a substantial contribution to the conception and the design of the study, analysing the data, drafting and revising the manuscript critically.All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:"]}
{"representative": "The four ligating atoms comprise the hydoxylate and carboxyl\u00adate O atoms from two independent benzilate ligands, each of which forms a five-membered chelating ring, spanning an axial and an equatorial site about the Sb atom. The hydroxy\u00adlate atoms occupy the two equatorial sites, and the carboxyl\u00adate atoms are in the pseudo-axial sites; the O\u2014Sb\u2014O angle is 147.72\u2005(5)\u00b0. One carboxyl\u00adate group shows quite different bond lengths from those of the other group; one O atom is clearly the carbonyl atom and the other O atom the hydroxy\u00adlate atom. In the other ligand, there is less distinction in the C\u2014O bonds. This is presumably related to the carbonyl O atom being the acceptor atom of a strong N\u2014H\u22efO hydrogen bond, which links the ammonium cation to the Sb complex anion.The coordination around the Sb atom in the title compound, (C DOI: 10.1107/S1600536809054853/pb2016Isup2.hkl            Structure factors: contains datablocks I. DOI:  crystallographic information; 3D view; checkCIF report            Additional supplementary materials:", "texts": ["The four ligating atoms comprise the hydoxylate and carboxyl\u00adate O atoms from two independent benzilate ligands, each of which forms a five-membered chelating ring, spanning an axial and an equatorial site about the Sb atom. The hydroxy\u00adlate atoms occupy the two equatorial sites, and the carboxyl\u00adate atoms are in the pseudo-axial sites; the O\u2014Sb\u2014O angle is 147.72\u2005(5)\u00b0. One carboxyl\u00adate group shows quite different bond lengths from those of the other group; one O atom is clearly the carbonyl atom and the other O atom the hydroxy\u00adlate atom. In the other ligand, there is less distinction in the C\u2014O bonds. This is presumably related to the carbonyl O atom being the acceptor atom of a strong N\u2014H\u22efO hydrogen bond, which links the ammonium cation to the Sb complex anion.The coordination around the Sb atom in the title compound, (C DOI: 10.1107/S1600536809054853/pb2016Isup2.hkl            Structure factors: contains datablocks I. DOI:  crystallographic information; 3D view; checkCIF report            Additional supplementary materials:"]}
{"representative": "The increased prevalence of overweight and obesity warrants preventive actions, particularly among people in transitional stages associated with lifestyle changes, such as occupational retirement. The purpose is to investigate the effect of a one year low-intensity computer-tailored energy balance programme among recent retirees on waist circumference, body weight and body composition, blood pressure, physical activity and dietary intake.A randomised controlled trial was conducted among recent retirees . Outcome measures were assessed using anthropometry, bio-impedance, blood pressure measurement and questionnaires.Waist circumference, body weight and blood pressure decreased significantly in men of the intervention and control group, but no significant between-group-differences were observed at 12 or at 24-months follow-up. A significant effect of the programme was only observed on waist circumference (-1.56 cm (95%CI: -2.91 to -0.21)) at 12 month follow up among men with low education (n = 85). Physical activity and dietary behaviours improved in both the intervention and control group during the intervention period. Although, these behaviours changed more favourably in the intervention group, these between-group-differences were not statistically significant.The multifaceted computer-tailored programme for recent retirees did not appear to be effective. Apparently the transition to occupational retirement and/or participation in the study had a greater impact than the intervention programme.Clinical Trials NCT00122213. The increasing prevalence of overweight and obesity also affects the older population  and prevIdeally, a behavioural intervention for this purpose should aim for small though sustainable changes to prevent gradual weight gain . PreferaWe developed and evaluated a one-year multifaceted programme including these factors using computer tailored feedback on physical activity and diet . The proSubjects were eligible for participation in the WAAG-Study (Wageningen Approach against fat Accumulation and weight Gain) if they were recent retirees (date of retirement maximum six months before or after baseline measurement), aged 55-65 years, and not undergoing any medical treatment that might affect body composition. Participants were recruited from pre-retirement workshops as offered by employers to approximately 10% of the Dutch retiring population. During such a five-day workshop several topics are discussed in order to prepare retirees for the new phase in life, e.g. changes in the household after retirement, health and vitality. Workshops were held all across The Netherlands. Approximately 1,100 workshop attendees were invited to participate in the WAAG-Study from September 2003 to mid March 2004. First follow-up measurements were conducted from September 2004 to the end of February 2005, and final follow-up measurements were conducted from September 2005 to the end of February 2006. The Medical Ethics Committee of Wageningen University approved the study protocol and all participants gave written informed consent upon enrolment after they received written and verbal information about the trial . In totaAll persons attending one single workshop (cluster) who were willing to participate were physically examined at the location of the workshop. Furthermore, questionnaires on demographics, physical activity, dietary intake and psychosocial determinants were handed out. Within one week after the workshop the clusters were randomly allocated to either the intervention or the control group. Cluster randomisation was performed in order to avoid induction of favourable behaviour change of individuals in the control group through their contacts with fellow participants in the intervention group. A randomisation list was generated beforehand by an independent person and took into account the number participants per workshop and the number of included clusters per week. Due to the nature of the study it was not blinded.Follow-up physical examinations were scheduled 12 \u00b1 0.5 months (on average 11.9 \u00b1 0.5 (mean \u00b1 SD); range 10.0-14.8 months) and 24 \u00b1 1.0 months  after the baseline examinations. At 12 months follow-up 94% and at 24 months follow-up 84% of the participants returned for re-examination. Drop out was mostly due to planning problems, since not all participants could be scheduled for an appointment within the set limits. There were no differences between those who dropped out  and those who remained.The intervention programme  was deveFive programme modules were provided to participants of the intervention group during the one year intervention period as shown in Figure During the total study period of two years, the control group was provided with newsletters with general information about the study, such as study progress, and information about art exhibitions and city trips for instance. They could not login to the website and had access to the general information about the study design only .Baseline physical examinations were performed at the site of the pre-retirement workshop, between 11 am and 2 pm. Follow-up examinations were conducted at various community health centres across the Netherlands at the same time of day. Examinations were carried out by the same two trained researchers over the total study period. Most participants (76%) were examined by the same researcher at baseline and 12 months follow-up and at the 24 months follow-up one researcher performed all examinations. Physical activity, diet, demographic and utilisation information were assessed by questionnaire. Questionnaires were handed out (baseline) and sent by mail (follow-up measurements) and were either returned in pre-paid envelopes (baseline) or handed in at follow-up physical examinations (12 and 24 months).Date of birth, date of retirement, physical activity level of their last job, and educational level were assessed by questionnaire. Activity level of the former job was based on four types of activities and ranged from non-active, e.g. administrative job, to very active, e.g. postmen. Highest attained education was categorised as 'low' , 'medium'  or 'high' .We also collected information on the use of the different modules of the intervention. Participants self-reported at all follow-up measurements whether or not they have used the modules once, twice or more. This is stated as utilisation per module and presented as a proportion of participants that returned the questionnaire.All anthropometrical measurements were performed while participants wore underwear only. Body weight was measured to the nearest 0.2 kg after regular calibration and height to the nearest 0.1 cm . Circumferences of the upper-arm, waist, hip, thigh, and calf were measured twice to the nearest 0.1 cm with a non-stretchable plastic measuring tape on the non-dominant side of the body, according to standard protocol ,18. AbdoTBW (kg) = 2.896 + 0.366*HEIGHT2(cm)/RESISTANCE100 kHz + 0.137*WEIGHT(KG) + 2.485*SEX  [WEIGHT -TBW)/0.732)/WEIGHT[A single frequency (100 kHz), tetra polar, body impedance analyser  was used to estimate total body water according to = women) . From to2)/WEIGHT.Blood pressure was assessed with participants in supine position using the average of two standard automatic blood pressure measurements .Changes in physical activity were assessed with the validated Dutch version of the Physical Activity Scale for the Elderly (PASE) . This brTotal PASE score was computed by multiplying the amount of time spent per activity (hours/day) and participation in the household activities by the item weights and then summing these products. The item weights indicate the contribution of each item to the overall PASE score; highest weights were assigned to the more strenuous types of activities . Six queFurther, we derived total time (min/week) spent on bicycling and walking as an indicator for routine daily activities and total time (min/week) spent on moderate and high intensity and muscle strengthening activities as an indicator of recreational and sports activities.Changes in the diet were assessed with a validated, semi-quantitative food frequency questionnaire (FFQ). The FFQ has been developed to estimate intake of fat, fatty acids, cholesterol and energy in adults using a reference period of four  weeks . All FFQFruit intake (g) was calculated by summing the amounts of fresh fruits. Vegetable intake (g) was calculated by summing the amounts of cooked, fried and raw vegetables. The sum of fruit and vegetable intake (g) was adjusted for energy intake (MJ). Furthermore, total fat intake (en%) and total energy intake (MJ/day) were derived for the FFQ.To estimate portion size, we used the total number of servings (of standard portion sizes) per month of certain energy dense products that are frequently consumed in the Netherlands: sliced meat, meat, beer and wine. To illustrate small adaptations, the number of sugar cubes in cups of coffee and tea, and milk added to a cup of coffee were evaluated.Subjects reporting extreme differences between baseline and 12 months follow-up (60% increase or decrease in energy intake (MJ/day)) were excluded from the analyses (n = 6).We hypothesised that waist circumference in the control group would increase by 0.5 cm (standard deviation of difference = 1.3 cm) per year and that it would remain stable in the intervention group . Based oproc mixed; SAS for Windows, SAS Institute Inc. Cary, NC, USA; version 9.1). Models were constructed with the follow-up measurements as dependent variable and the baseline measurement as covariate. The estimate for treatment effect reflects the between-group-difference at follow-up, corrected for the value at baseline.The effect estimates of the intervention included all participants who had provided at least one follow-up measurement. Data were analysed using mixed models with a random cluster effect allowing each cluster to have its own intercept. Analyses were performed using SAS (d) were interpreted according to the Cohen's guidelines and indicate the size of the effect of the programme. Cut off points for small effects are d < 0.32, medium effects as 0.33 <d < 0.55 and large as d > 0.56 [Additionally, we calculated effect sizes, a frequently used measure to demonstrate the magnitude of the effect of an intervention programme. The standardised effect size is calculated as the difference between the mean changes between the intervention and control group divided by the pooled standard deviation . Effect d > 0.56 . We also2 and a waist circumference \u2265 102 cm [Secondary analyses were performed for waist circumference and body weight and fat intake and energy intake at 12 months follow-up in pre-defined subgroups of participants having low educational level , physically active former job, a BMI \u2265 30 kg/m\u2265 102 cm . Also anAll statistical analyses were performed for men only, because age related changes in body composition differ between sexes and the number of women was too small to have sufficient power to draw conclusions. Statistical significance was set at p < 0.05 for all tests performed.2  and body weight . Although the declines were greater in the intervention group, the between-group-differences were not significant  .At 12-months follow-up, there was a significant decline (mean change) in waist circumference , sum of household activities , and total physical activity ((PASE) INT: 22.9; CON: 17.6) increased significantly. However, the between-group-differences were not significant  (Table Among men in both groups daily activities (y) Table . Men in y) Table .Waist circumference in men in the intervention and control group remained lower compared to baseline, though during the second year of follow-up an increase was observed. Body weight stabilised in both groups. Again the between-group-differences for waist circumference and body weight were not statistically significant Table .INT: 0.9; CON: 1.2; p = 0.03) in favour of the control group. For other lifestyle behaviours mentioned in Table Change in sport and recreational activities was higher after two year in the intervention group (74.5 min/week) compared to the control group . The sum of household activities increased in both groups  revealed a significant between-group-difference in waist circumference of -1.56 cm  at 12 month follow-up in favour of the intervention group. In this subgroup the reduction in body weight was also larger in the intervention group compared to the control group. However, the between-group-difference of -0.96 kg (95%CI: -2.40 to 0.47) was not significant. There were no significant differences in changes in waist circumference and body weight between the intervention and control group observed in any other predefined subgroup.Secondary analyses among men with low educational level   in the intervention group, while an increase was observed in the control group . The between-group-difference was -3.2 en% (p = 0.01).The per protocol analyses to test the influence of utilisation of the key modules did not reveal any differences between those that had actually utilised the modules once or more versus the randomly selected sex-matched control group at 12 and 24-months follow-up (data not shown).Retired subjects participating in a one- year low intensity energy balance programme decreased their waist circumference, body weight, BMI, blood pressure and most other body composition indices and improved their physical activity and dietary behaviour. Although the changes were more consistent and more pronounced among subjects of the intervention group, the between-group-differences were small and mostly not statistically significant. Additional analyses among low educated men indicate that the programme may be effective in men with a low educational level: for waist circumference and fat intake the between-group-differences were significantly different. After the follow-up period the between-group-differences more or less remained the same, though the magnitude of the differences diminished.We hypothesised that the intervention group would maintain their waist circumference and body weight in the two years following transition to retirement as opposed to the control group. Within the control group, the waist circumference would on average increase by 0.5 cm per year. Remarkably, in men, both groups reduced their body weight and weight circumference. And although the difference in change was -0.48, we could not demonstrate a significant effect. Possibly our study lacked statistical power. The sample size was calculated based on observational data on change in waist circumference in a middle-aged population. Such data were not available for the specific group of retirees we studied. Apparently, the variance that was used for the power calculation was too low. Further, despite the randomisation, the control group had on average higher, though non significant, scores for the outcome measurements at baseline, which may have caused regression to the mean. However, we included baseline values in the models and thus have allowed for these apparent differences.The lack of effect may also be due to our recruitment strategy resulting in a relatively healthy and health conscious group of subjects. The study participants were selected from pre-retirement workshops, often attended by higher socio-economic groups, who in general are more motivated to change physical activity and diet, which might have reduced the added value of the prevention programme. Earlier studies have described that individuals willing to participate in health promoting intervention studies are already interested in diet and physical activity and are health conscious ,31.Further, study participation itself may have led to increased awareness and motivation to change physical activity and/or diet in the control group and intervention group (Hawthorne effect), which also reduced the added value of the programme. The influence of the researchers or others involved in measurements is supposed to be very low, since information associated with the content of the intervention was not discussed at the physical examinations or during other contacts.et al, showed that in transition to retirement subjects decrease work-related activity and increase household activities as well as doing odd jobs [And last but not least, transition to occupational retirement per se may have induced the changes in (lifestyle) behaviours. The study by Nooyens odd jobs . Maybe tA limitation of the study is the small number of females. Although the percentage of women that participated is representative for the percentage of women that worked in this age group, the number was too small to draw conclusions on the effectiveness of the intervention. And although the PASE questionnaire was originally designed for older adults (65+ years) it was chosen because it distinguishes activities (household -and leisure activities) that are relevant for retired people. Moreover, the recall period was only one week which also enabled us to pick up changes over a short period of time.et al showed that determinants of weight gain among older populations do not really differ from determinants in adult populations [The programme of our study was developed according to the Intervention Mapping Protocol . This syulations .Our programme aimed to induce relatively small and possibly sustainable changes in physical activity and diet to prevent weight gain ,10.Moreover, the programme was developed in a way that it could be implemented nationwide, thus it was of low intensity, easily accessible and home-based. As a result, participants could voluntarily use the modules of the programme in accordance with their personal preferences. As a consequence commitment and adherence of the target group may have been too weak to result in a behaviour change.Although the use of personal computers and internet in the middle-aged has increased rapidly in recent years , it is uThe results of this study can by used by the Netherlands Heart Foundation and others to further improve the intervention modules. At present it is not clear if or how the results of this study will lead to further development or implementation of this intervention.The individually tailored one year energy balance programme did not have a significant effect on any of the outcomes in recent retirees though it showed a pattern of small, non- significant effects on changes in body composition, physical activity and dietary behaviour. Lack of power may partly account for these findings. Apparently transition to occupational retirement and/or participation in research had a greater impact than the intervention programme itself.The authors declare that they have no competing interests.AW, AJS, FJK and EGS were the principal investigators of the study and developed the concept and the design of the study. PJMH contributed to the body composition assessment, AS and SK contributed to the behavioural parts of the intervention and to the assessment of behaviour. AW performed the analyses and AW and JS drafted the manuscript. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2458/10/110/prepub", "texts": ["The increased prevalence of overweight and obesity warrants preventive actions, particularly among people in transitional stages associated with lifestyle changes, such as occupational retirement. The purpose is to investigate the effect of a one year low-intensity computer-tailored energy balance programme among recent retirees on waist circumference, body weight and body composition, blood pressure, physical activity and dietary intake.A randomised controlled trial was conducted among recent retirees . Outcome measures were assessed using anthropometry, bio-impedance, blood pressure measurement and questionnaires.Waist circumference, body weight and blood pressure decreased significantly in men of the intervention and control group, but no significant between-group-differences were observed at 12 or at 24-months follow-up. A significant effect of the programme was only observed on waist circumference (-1.56 cm (95%CI: -2.91 to -0.21)) at 12 month follow up among men with low education (n = 85). Physical activity and dietary behaviours improved in both the intervention and control group during the intervention period. Although, these behaviours changed more favourably in the intervention group, these between-group-differences were not statistically significant.The multifaceted computer-tailored programme for recent retirees did not appear to be effective. Apparently the transition to occupational retirement and/or participation in the study had a greater impact than the intervention programme.Clinical Trials NCT00122213. The increasing prevalence of overweight and obesity also affects the older population  and prevIdeally, a behavioural intervention for this purpose should aim for small though sustainable changes to prevent gradual weight gain . PreferaWe developed and evaluated a one-year multifaceted programme including these factors using computer tailored feedback on physical activity and diet . The proSubjects were eligible for participation in the WAAG-Study (Wageningen Approach against fat Accumulation and weight Gain) if they were recent retirees (date of retirement maximum six months before or after baseline measurement), aged 55-65 years, and not undergoing any medical treatment that might affect body composition. Participants were recruited from pre-retirement workshops as offered by employers to approximately 10% of the Dutch retiring population. During such a five-day workshop several topics are discussed in order to prepare retirees for the new phase in life, e.g. changes in the household after retirement, health and vitality. Workshops were held all across The Netherlands. Approximately 1,100 workshop attendees were invited to participate in the WAAG-Study from September 2003 to mid March 2004. First follow-up measurements were conducted from September 2004 to the end of February 2005, and final follow-up measurements were conducted from September 2005 to the end of February 2006. The Medical Ethics Committee of Wageningen University approved the study protocol and all participants gave written informed consent upon enrolment after they received written and verbal information about the trial . In totaAll persons attending one single workshop (cluster) who were willing to participate were physically examined at the location of the workshop. Furthermore, questionnaires on demographics, physical activity, dietary intake and psychosocial determinants were handed out. Within one week after the workshop the clusters were randomly allocated to either the intervention or the control group. Cluster randomisation was performed in order to avoid induction of favourable behaviour change of individuals in the control group through their contacts with fellow participants in the intervention group. A randomisation list was generated beforehand by an independent person and took into account the number participants per workshop and the number of included clusters per week. Due to the nature of the study it was not blinded.Follow-up physical examinations were scheduled 12 \u00b1 0.5 months (on average 11.9 \u00b1 0.5 (mean \u00b1 SD); range 10.0-14.8 months) and 24 \u00b1 1.0 months  after the baseline examinations. At 12 months follow-up 94% and at 24 months follow-up 84% of the participants returned for re-examination. Drop out was mostly due to planning problems, since not all participants could be scheduled for an appointment within the set limits. There were no differences between those who dropped out  and those who remained.The intervention programme  was deveFive programme modules were provided to participants of the intervention group during the one year intervention period as shown in Figure During the total study period of two years, the control group was provided with newsletters with general information about the study, such as study progress, and information about art exhibitions and city trips for instance. They could not login to the website and had access to the general information about the study design only .Baseline physical examinations were performed at the site of the pre-retirement workshop, between 11 am and 2 pm. Follow-up examinations were conducted at various community health centres across the Netherlands at the same time of day. Examinations were carried out by the same two trained researchers over the total study period. Most participants (76%) were examined by the same researcher at baseline and 12 months follow-up and at the 24 months follow-up one researcher performed all examinations. Physical activity, diet, demographic and utilisation information were assessed by questionnaire. Questionnaires were handed out (baseline) and sent by mail (follow-up measurements) and were either returned in pre-paid envelopes (baseline) or handed in at follow-up physical examinations (12 and 24 months).Date of birth, date of retirement, physical activity level of their last job, and educational level were assessed by questionnaire. Activity level of the former job was based on four types of activities and ranged from non-active, e.g. administrative job, to very active, e.g. postmen. Highest attained education was categorised as 'low' , 'medium'  or 'high' .We also collected information on the use of the different modules of the intervention. Participants self-reported at all follow-up measurements whether or not they have used the modules once, twice or more. This is stated as utilisation per module and presented as a proportion of participants that returned the questionnaire.All anthropometrical measurements were performed while participants wore underwear only. Body weight was measured to the nearest 0.2 kg after regular calibration and height to the nearest 0.1 cm . Circumferences of the upper-arm, waist, hip, thigh, and calf were measured twice to the nearest 0.1 cm with a non-stretchable plastic measuring tape on the non-dominant side of the body, according to standard protocol ,18. AbdoTBW (kg) = 2.896 + 0.366*HEIGHT2(cm)/RESISTANCE100 kHz + 0.137*WEIGHT(KG) + 2.485*SEX  [WEIGHT -TBW)/0.732)/WEIGHT[A single frequency (100 kHz), tetra polar, body impedance analyser  was used to estimate total body water according to = women) . From to2)/WEIGHT.Blood pressure was assessed with participants in supine position using the average of two standard automatic blood pressure measurements .Changes in physical activity were assessed with the validated Dutch version of the Physical Activity Scale for the Elderly (PASE) . This brTotal PASE score was computed by multiplying the amount of time spent per activity (hours/day) and participation in the household activities by the item weights and then summing these products. The item weights indicate the contribution of each item to the overall PASE score; highest weights were assigned to the more strenuous types of activities . Six queFurther, we derived total time (min/week) spent on bicycling and walking as an indicator for routine daily activities and total time (min/week) spent on moderate and high intensity and muscle strengthening activities as an indicator of recreational and sports activities.Changes in the diet were assessed with a validated, semi-quantitative food frequency questionnaire (FFQ). The FFQ has been developed to estimate intake of fat, fatty acids, cholesterol and energy in adults using a reference period of four  weeks . All FFQFruit intake (g) was calculated by summing the amounts of fresh fruits. Vegetable intake (g) was calculated by summing the amounts of cooked, fried and raw vegetables. The sum of fruit and vegetable intake (g) was adjusted for energy intake (MJ). Furthermore, total fat intake (en%) and total energy intake (MJ/day) were derived for the FFQ.To estimate portion size, we used the total number of servings (of standard portion sizes) per month of certain energy dense products that are frequently consumed in the Netherlands: sliced meat, meat, beer and wine. To illustrate small adaptations, the number of sugar cubes in cups of coffee and tea, and milk added to a cup of coffee were evaluated.Subjects reporting extreme differences between baseline and 12 months follow-up (60% increase or decrease in energy intake (MJ/day)) were excluded from the analyses (n = 6).We hypothesised that waist circumference in the control group would increase by 0.5 cm (standard deviation of difference = 1.3 cm) per year and that it would remain stable in the intervention group . Based oproc mixed; SAS for Windows, SAS Institute Inc. Cary, NC, USA; version 9.1). Models were constructed with the follow-up measurements as dependent variable and the baseline measurement as covariate. The estimate for treatment effect reflects the between-group-difference at follow-up, corrected for the value at baseline.The effect estimates of the intervention included all participants who had provided at least one follow-up measurement. Data were analysed using mixed models with a random cluster effect allowing each cluster to have its own intercept. Analyses were performed using SAS (d) were interpreted according to the Cohen's guidelines and indicate the size of the effect of the programme. Cut off points for small effects are d < 0.32, medium effects as 0.33 <d < 0.55 and large as d > 0.56 [Additionally, we calculated effect sizes, a frequently used measure to demonstrate the magnitude of the effect of an intervention programme. The standardised effect size is calculated as the difference between the mean changes between the intervention and control group divided by the pooled standard deviation . Effect d > 0.56 . We also2 and a waist circumference \u2265 102 cm [Secondary analyses were performed for waist circumference and body weight and fat intake and energy intake at 12 months follow-up in pre-defined subgroups of participants having low educational level , physically active former job, a BMI \u2265 30 kg/m\u2265 102 cm . Also anAll statistical analyses were performed for men only, because age related changes in body composition differ between sexes and the number of women was too small to have sufficient power to draw conclusions. Statistical significance was set at p < 0.05 for all tests performed.2  and body weight . Although the declines were greater in the intervention group, the between-group-differences were not significant  .At 12-months follow-up, there was a significant decline (mean change) in waist circumference , sum of household activities , and total physical activity ((PASE) INT: 22.9; CON: 17.6) increased significantly. However, the between-group-differences were not significant  (Table Among men in both groups daily activities (y) Table . Men in y) Table .Waist circumference in men in the intervention and control group remained lower compared to baseline, though during the second year of follow-up an increase was observed. Body weight stabilised in both groups. Again the between-group-differences for waist circumference and body weight were not statistically significant Table .INT: 0.9; CON: 1.2; p = 0.03) in favour of the control group. For other lifestyle behaviours mentioned in Table Change in sport and recreational activities was higher after two year in the intervention group (74.5 min/week) compared to the control group . The sum of household activities increased in both groups  revealed a significant between-group-difference in waist circumference of -1.56 cm  at 12 month follow-up in favour of the intervention group. In this subgroup the reduction in body weight was also larger in the intervention group compared to the control group. However, the between-group-difference of -0.96 kg (95%CI: -2.40 to 0.47) was not significant. There were no significant differences in changes in waist circumference and body weight between the intervention and control group observed in any other predefined subgroup.Secondary analyses among men with low educational level   in the intervention group, while an increase was observed in the control group . The between-group-difference was -3.2 en% (p = 0.01).The per protocol analyses to test the influence of utilisation of the key modules did not reveal any differences between those that had actually utilised the modules once or more versus the randomly selected sex-matched control group at 12 and 24-months follow-up (data not shown).Retired subjects participating in a one- year low intensity energy balance programme decreased their waist circumference, body weight, BMI, blood pressure and most other body composition indices and improved their physical activity and dietary behaviour. Although the changes were more consistent and more pronounced among subjects of the intervention group, the between-group-differences were small and mostly not statistically significant. Additional analyses among low educated men indicate that the programme may be effective in men with a low educational level: for waist circumference and fat intake the between-group-differences were significantly different. After the follow-up period the between-group-differences more or less remained the same, though the magnitude of the differences diminished.We hypothesised that the intervention group would maintain their waist circumference and body weight in the two years following transition to retirement as opposed to the control group. Within the control group, the waist circumference would on average increase by 0.5 cm per year. Remarkably, in men, both groups reduced their body weight and weight circumference. And although the difference in change was -0.48, we could not demonstrate a significant effect. Possibly our study lacked statistical power. The sample size was calculated based on observational data on change in waist circumference in a middle-aged population. Such data were not available for the specific group of retirees we studied. Apparently, the variance that was used for the power calculation was too low. Further, despite the randomisation, the control group had on average higher, though non significant, scores for the outcome measurements at baseline, which may have caused regression to the mean. However, we included baseline values in the models and thus have allowed for these apparent differences.The lack of effect may also be due to our recruitment strategy resulting in a relatively healthy and health conscious group of subjects. The study participants were selected from pre-retirement workshops, often attended by higher socio-economic groups, who in general are more motivated to change physical activity and diet, which might have reduced the added value of the prevention programme. Earlier studies have described that individuals willing to participate in health promoting intervention studies are already interested in diet and physical activity and are health conscious ,31.Further, study participation itself may have led to increased awareness and motivation to change physical activity and/or diet in the control group and intervention group (Hawthorne effect), which also reduced the added value of the programme. The influence of the researchers or others involved in measurements is supposed to be very low, since information associated with the content of the intervention was not discussed at the physical examinations or during other contacts.et al, showed that in transition to retirement subjects decrease work-related activity and increase household activities as well as doing odd jobs [And last but not least, transition to occupational retirement per se may have induced the changes in (lifestyle) behaviours. The study by Nooyens odd jobs . Maybe tA limitation of the study is the small number of females. Although the percentage of women that participated is representative for the percentage of women that worked in this age group, the number was too small to draw conclusions on the effectiveness of the intervention. And although the PASE questionnaire was originally designed for older adults (65+ years) it was chosen because it distinguishes activities (household -and leisure activities) that are relevant for retired people. Moreover, the recall period was only one week which also enabled us to pick up changes over a short period of time.et al showed that determinants of weight gain among older populations do not really differ from determinants in adult populations [The programme of our study was developed according to the Intervention Mapping Protocol . This syulations .Our programme aimed to induce relatively small and possibly sustainable changes in physical activity and diet to prevent weight gain ,10.Moreover, the programme was developed in a way that it could be implemented nationwide, thus it was of low intensity, easily accessible and home-based. As a result, participants could voluntarily use the modules of the programme in accordance with their personal preferences. As a consequence commitment and adherence of the target group may have been too weak to result in a behaviour change.Although the use of personal computers and internet in the middle-aged has increased rapidly in recent years , it is uThe results of this study can by used by the Netherlands Heart Foundation and others to further improve the intervention modules. At present it is not clear if or how the results of this study will lead to further development or implementation of this intervention.The individually tailored one year energy balance programme did not have a significant effect on any of the outcomes in recent retirees though it showed a pattern of small, non- significant effects on changes in body composition, physical activity and dietary behaviour. Lack of power may partly account for these findings. Apparently transition to occupational retirement and/or participation in research had a greater impact than the intervention programme itself.The authors declare that they have no competing interests.AW, AJS, FJK and EGS were the principal investigators of the study and developed the concept and the design of the study. PJMH contributed to the body composition assessment, AS and SK contributed to the behavioural parts of the intervention and to the assessment of behaviour. AW performed the analyses and AW and JS drafted the manuscript. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2458/10/110/prepub"]}
{"representative": "Mother's diet during pregnancy is important, since plant lignans and their metabolites, converted by the intestinal microflora to enterolignans, are proposed to possess multiple health benefits. Aim of our study was to investigate whether a dietary intervention affects lignan concentrations in the serum of pregnant women.A controlled dietary intervention trial including 105 first-time pregnant women was conducted in three intervention and three control maternity health clinics. The intervention included individual counseling on diet and on physical activity, while the controls received conventional care. Blood samples were collected on gestation weeks 8-9 (baseline) and 36-37 (end of intervention). The serum levels of the plant lignans 7-hydroxymatairesinol, secoisolariciresinol, matairesinol, lariciresinol, cyclolariciresinol, and pinoresinol, and of the enterolignans 7-hydroxyenterolactone, enterodiol, and enterolactone, were measured using a validated method.The baseline levels of enterolactone, enterodiol and the sum of lignans were higher in the control group, whereas at the end of the trial their levels were higher in the intervention group. The adjusted mean differences between the baseline and end of the intervention for enterolactone and the total lignan intake were 1.6 ng/ml  and 1.4 ng/mg  higher in the intervention group than in the controls. Further adjustment for dietary components did not change these associations.The dietary intervention was successful in increasing the intake of lignan-rich food products, the fiber consumption and consequently the plasma levels of lignans in pregnant women.http://www.isrctn.orgISRCTN21512277,  During pregnancy, the fetus is exposed to multiple biologically active compounds that originate from the maternal diet. Some of these may affect offspring's later health. Dietary phytoestrogens are examples of such compounds, as they are found in the amniotic fluid and the umbilical cord blood . In the Dietary lignans have been portrayed as health-promoting agents in many epidemiological studies, which show an inverse association between plant lignan intake or serum/urine enterolignan concentrations and chronic Western life-style diseases, including breast and colon cancer, and cardiovascular diseases . FurtherSeveral studies indicate that supplementation of a habitual diet with lignan-rich foods can affect circulating enterolignan concentrations in women . HoweverEach municipality in Finland is responsible for arranging maternity health-care services for its residents, and these are covered by public tax revenue. Almost all (99.7%) pregnant women attend public maternity clinics . The preIn the Finnish maternity health-care system, pregnant women are recommended to visit 11-15 times a nurse and three times to a physician. This study was implemented during two of these routine visits to nurses at gestation weeks 8-9 (baseline) and 36-37 (end of intervention).The participants were pregnant women with no earlier deliveries. Women who were younger than 18 years of age, or suffered from type I or type II diabetes mellitus, twin pregnancy, physical disability that prevented exercising or had otherwise problematic pregnancy, substance abuse, treatment or clinical history of any psychiatric illness, were unable to speak Finnish, or intended to change residence within three months, were excluded from the study. The nurses recruited the participants when they enrolled for their first clinic visit at the beginning of their pregnancy, usually by phone. Forty-nine women in the intervention clinics and 56 women in the control clinics gave informed consent for participation. Recruitment took place between August 2004 and January 2005.The participants visiting the control clinics received the standard maternity care. The intervention group received recommendations for gestational weight gain and physical activity counseling, the details of which are presented elsewhere ,13.For the dietary counseling, the following dietary objectives were set for each participant to achieve or maintain: 1) to follow a regular meal pattern, emphasizing the importance of breakfast and > = 1 hot meal every day, 2) to eat at least five portions (400 g) per day, in total, of different kinds of vegetables, fruits and berries, 3) to consume preferentially high-fibre bread (> = 5 g fibre/100 g), and 4) to restrict the intake of high-sugar snacks to < = 1 portion per day . The dietary counselling consisted of one primary counselling session  at the visit during gestation weeks 16-18, and three booster sessions  until gestation week 37.The pre-pregnancy weight and height were self-reported, whereas weight development during the pregnancy was based on measurement by nurses in maternity centers. The baseline questionnaire, including questions on background, lifestyle and dietary intake (a 57-item food frequency questionnaire), was completed before the first visit (at gestation week 8 or 9). The second follow-up questionnaire was completed at the end of the study, on gestation week 37. Similar FFQ was filled by both groups. The baseline dietary information was based on the diet during the month before the pregnancy and the follow-up information on the diet during the month before the 26 to 28 pregnancy week's visit.m/z 151, and deuterated matairesinol was used as internal standard.The plant lignans 7-hydroxymatairesinol, secoisolariciresinol, matairesinol, lariciresinol, cyclolariciresinol, and pinoresinol, and the enterolignans 7-hydroxyenterolactone, enterodiol, and enterolactone were quantified in the serum using a previously developed and validated high-performance liquid chromatography-tandem mass spectrometric (HPLC-MS/MS) method . BrieflyBaseline information on age, pre-pregnancy BMI, weight gain during pregnancy, education level and smoking status before and during pregnancy were reported by both in the intervention and the control groups. Education was self-reported and categorized as basic or secondary education, polytechnic or university training. Smoking was inquired both before  and during pregnancy . These variables were later included, when necessary, as confounding factors in the multivariable analyses. In all statistical analyses, p < 0.05 was used as the level of statistical significance.The group differences of lignans at the end point of both follow-ups adjusted for the baseline level of lignans and other possible confounders were examined by the linear regression model. The original lignan values were skewed, and were transformed by using the logarithm to enable statistical analysis requiring normally distributed variables. The results at the end point of each follow-up are illustrated as a group difference calculated using antilogs of mean differences of log-transformed variables, and presented with 95% CI.In the regression model, the analyses included baseline level of lignans, age, BMI, education, smoking and change in consumption of vegetables and fruits. Further adjustment was performed for dietary components that affect lignan intake or are thought to intervene with lignan metabolism. These were coffee, tea, other drinks, butter, potato, peas, milk products, pork, beef, and sugar. Since these dietary variables were not significant, they were dropped out from the backward stepwise regression model.Women in the intervention group were younger, less educated, and were more often smokers, and they had a higher pre-pregnancy weight and BMI on average than the women in the control group Table .Enterolactone was detectable in almost all the samples Table . Other lGroup differences were analyzed taking into account baseline lignans, age, BMI, education and smoking. The adjusted mean difference for enterolactone at the end of the intervention when compared to the baseline was 1.6 ng/ml higher in the intervention group than in the controls . Similar results were found for enterolignan . The mean adjusted difference between baseline and end for the sum of lignans was 1.4 ng/ml  higher in intervention group than in the controls .The intervention group was less educated than the control group. Education is widely known to be associated with diet and BMI  and may The small sample size was also a limitation of this study. Due to the small number of clinics, the clinic-level variation could not be taken into account by using multilevel analysis. Furthermore, there were more drop-outs in the intervention group than in the control group. Although the drop-out reasons were only partly related to the study, the drop-outs might have been less motivated to change their health behavior. In this pilot study, information on diet was obtained by questionnaires, which have not been validated for pregnant women. Additionally, use of food frequency questionnaire may be a limitation since the groups are not directly comparable. Weight before the pregnancy was self-reported, which may induce some bias. However, weight development during the pregnancy was measured by the nurses, and thus more reliably collected.The pregnant women in this study were healthy primiparas, who had relatively healthy dietary and physical activity habits. Therefore, there may not have been much room to further improve their diet. However, changes were noticed on diet and serum lignan levels among the women in the intervention group, indicating that the dietary intervention was successful.It is essential to determine whether this pregnancy intervention has any impact on the offspring's health. In our previous study, none of the newborns in the intervention group had a high birthweight  - an indWe have shown earlier by using animal models that changes in maternal diet during pregnancy alter mammary cancer risk among female offspring ,21. OtheThe authors declare that they have no competing interests.RL is principal investigator in the clinical trial study. EK, JR and NS were responsible for data management. AIS is responsible for all chemical analyses. EK, MF and JR conducted statistical analyses. LHC contributed to the article on expertise on nutrition and animal models, and all authors contributed in writing of the paper.Flow chart of the trial. Flow chart of the cluster-randomized trial showing participating clinics, number of women eligible, randomized and drop-outs.Click here for file", "texts": ["Mother's diet during pregnancy is important, since plant lignans and their metabolites, converted by the intestinal microflora to enterolignans, are proposed to possess multiple health benefits. Aim of our study was to investigate whether a dietary intervention affects lignan concentrations in the serum of pregnant women.A controlled dietary intervention trial including 105 first-time pregnant women was conducted in three intervention and three control maternity health clinics. The intervention included individual counseling on diet and on physical activity, while the controls received conventional care. Blood samples were collected on gestation weeks 8-9 (baseline) and 36-37 (end of intervention). The serum levels of the plant lignans 7-hydroxymatairesinol, secoisolariciresinol, matairesinol, lariciresinol, cyclolariciresinol, and pinoresinol, and of the enterolignans 7-hydroxyenterolactone, enterodiol, and enterolactone, were measured using a validated method.The baseline levels of enterolactone, enterodiol and the sum of lignans were higher in the control group, whereas at the end of the trial their levels were higher in the intervention group. The adjusted mean differences between the baseline and end of the intervention for enterolactone and the total lignan intake were 1.6 ng/ml  and 1.4 ng/mg  higher in the intervention group than in the controls. Further adjustment for dietary components did not change these associations.The dietary intervention was successful in increasing the intake of lignan-rich food products, the fiber consumption and consequently the plasma levels of lignans in pregnant women.http://www.isrctn.orgISRCTN21512277,  During pregnancy, the fetus is exposed to multiple biologically active compounds that originate from the maternal diet. Some of these may affect offspring's later health. Dietary phytoestrogens are examples of such compounds, as they are found in the amniotic fluid and the umbilical cord blood . In the Dietary lignans have been portrayed as health-promoting agents in many epidemiological studies, which show an inverse association between plant lignan intake or serum/urine enterolignan concentrations and chronic Western life-style diseases, including breast and colon cancer, and cardiovascular diseases . FurtherSeveral studies indicate that supplementation of a habitual diet with lignan-rich foods can affect circulating enterolignan concentrations in women . HoweverEach municipality in Finland is responsible for arranging maternity health-care services for its residents, and these are covered by public tax revenue. Almost all (99.7%) pregnant women attend public maternity clinics . The preIn the Finnish maternity health-care system, pregnant women are recommended to visit 11-15 times a nurse and three times to a physician. This study was implemented during two of these routine visits to nurses at gestation weeks 8-9 (baseline) and 36-37 (end of intervention).The participants were pregnant women with no earlier deliveries. Women who were younger than 18 years of age, or suffered from type I or type II diabetes mellitus, twin pregnancy, physical disability that prevented exercising or had otherwise problematic pregnancy, substance abuse, treatment or clinical history of any psychiatric illness, were unable to speak Finnish, or intended to change residence within three months, were excluded from the study. The nurses recruited the participants when they enrolled for their first clinic visit at the beginning of their pregnancy, usually by phone. Forty-nine women in the intervention clinics and 56 women in the control clinics gave informed consent for participation. Recruitment took place between August 2004 and January 2005.The participants visiting the control clinics received the standard maternity care. The intervention group received recommendations for gestational weight gain and physical activity counseling, the details of which are presented elsewhere ,13.For the dietary counseling, the following dietary objectives were set for each participant to achieve or maintain: 1) to follow a regular meal pattern, emphasizing the importance of breakfast and > = 1 hot meal every day, 2) to eat at least five portions (400 g) per day, in total, of different kinds of vegetables, fruits and berries, 3) to consume preferentially high-fibre bread (> = 5 g fibre/100 g), and 4) to restrict the intake of high-sugar snacks to < = 1 portion per day . The dietary counselling consisted of one primary counselling session  at the visit during gestation weeks 16-18, and three booster sessions  until gestation week 37.The pre-pregnancy weight and height were self-reported, whereas weight development during the pregnancy was based on measurement by nurses in maternity centers. The baseline questionnaire, including questions on background, lifestyle and dietary intake (a 57-item food frequency questionnaire), was completed before the first visit (at gestation week 8 or 9). The second follow-up questionnaire was completed at the end of the study, on gestation week 37. Similar FFQ was filled by both groups. The baseline dietary information was based on the diet during the month before the pregnancy and the follow-up information on the diet during the month before the 26 to 28 pregnancy week's visit.m/z 151, and deuterated matairesinol was used as internal standard.The plant lignans 7-hydroxymatairesinol, secoisolariciresinol, matairesinol, lariciresinol, cyclolariciresinol, and pinoresinol, and the enterolignans 7-hydroxyenterolactone, enterodiol, and enterolactone were quantified in the serum using a previously developed and validated high-performance liquid chromatography-tandem mass spectrometric (HPLC-MS/MS) method . BrieflyBaseline information on age, pre-pregnancy BMI, weight gain during pregnancy, education level and smoking status before and during pregnancy were reported by both in the intervention and the control groups. Education was self-reported and categorized as basic or secondary education, polytechnic or university training. Smoking was inquired both before  and during pregnancy . These variables were later included, when necessary, as confounding factors in the multivariable analyses. In all statistical analyses, p < 0.05 was used as the level of statistical significance.The group differences of lignans at the end point of both follow-ups adjusted for the baseline level of lignans and other possible confounders were examined by the linear regression model. The original lignan values were skewed, and were transformed by using the logarithm to enable statistical analysis requiring normally distributed variables. The results at the end point of each follow-up are illustrated as a group difference calculated using antilogs of mean differences of log-transformed variables, and presented with 95% CI.In the regression model, the analyses included baseline level of lignans, age, BMI, education, smoking and change in consumption of vegetables and fruits. Further adjustment was performed for dietary components that affect lignan intake or are thought to intervene with lignan metabolism. These were coffee, tea, other drinks, butter, potato, peas, milk products, pork, beef, and sugar. Since these dietary variables were not significant, they were dropped out from the backward stepwise regression model.Women in the intervention group were younger, less educated, and were more often smokers, and they had a higher pre-pregnancy weight and BMI on average than the women in the control group Table .Enterolactone was detectable in almost all the samples Table . Other lGroup differences were analyzed taking into account baseline lignans, age, BMI, education and smoking. The adjusted mean difference for enterolactone at the end of the intervention when compared to the baseline was 1.6 ng/ml higher in the intervention group than in the controls . Similar results were found for enterolignan . The mean adjusted difference between baseline and end for the sum of lignans was 1.4 ng/ml  higher in intervention group than in the controls .The intervention group was less educated than the control group. Education is widely known to be associated with diet and BMI  and may The small sample size was also a limitation of this study. Due to the small number of clinics, the clinic-level variation could not be taken into account by using multilevel analysis. Furthermore, there were more drop-outs in the intervention group than in the control group. Although the drop-out reasons were only partly related to the study, the drop-outs might have been less motivated to change their health behavior. In this pilot study, information on diet was obtained by questionnaires, which have not been validated for pregnant women. Additionally, use of food frequency questionnaire may be a limitation since the groups are not directly comparable. Weight before the pregnancy was self-reported, which may induce some bias. However, weight development during the pregnancy was measured by the nurses, and thus more reliably collected.The pregnant women in this study were healthy primiparas, who had relatively healthy dietary and physical activity habits. Therefore, there may not have been much room to further improve their diet. However, changes were noticed on diet and serum lignan levels among the women in the intervention group, indicating that the dietary intervention was successful.It is essential to determine whether this pregnancy intervention has any impact on the offspring's health. In our previous study, none of the newborns in the intervention group had a high birthweight  - an indWe have shown earlier by using animal models that changes in maternal diet during pregnancy alter mammary cancer risk among female offspring ,21. OtheThe authors declare that they have no competing interests.RL is principal investigator in the clinical trial study. EK, JR and NS were responsible for data management. AIS is responsible for all chemical analyses. EK, MF and JR conducted statistical analyses. LHC contributed to the article on expertise on nutrition and animal models, and all authors contributed in writing of the paper.Flow chart of the trial. Flow chart of the cluster-randomized trial showing participating clinics, number of women eligible, randomized and drop-outs.Click here for file"]}
{"representative": "A collection of primitive operations for molecular diagram sketching has been developed. These primitives compose a concise set of operations which can be used to construct publication-quality 2 D coordinates for molecular structures using a bare minimum of input bandwidth. The input requirements for each primitive consist of a small number of discrete choices, which means that these primitives can be used to form the basis of a user interface which does not require an accurate pointing device. This is particularly relevant to software designed for contemporary mobile platforms. The reduction of input bandwidth is accomplished by using algorithmic methods for anticipating probable geometries during the sketching process, and by intelligent use of template grafting. The algorithms and their uses are described in detail. Molecular structure diagrams have been the mainstay of chemical communication since molecules began to be rationalised as Lewis structures. The basic ideas involved in representing structures have proven to be remarkably resilient -3. WhileIn recent decades, the process of creating molecular structure diagrams has steadily shifted towards use of computer software, which is now used exclusively for publications, and is in the process of replacing hand-drawings by way of electronic lab notebooks . There iThe subject of this work is a slightly different perspective on the drawing of a 2 D molecular structure diagram. Assuming that the composition of the molecule is known, and the desired output is an arrangement of atoms and bonds onto a flat surface, the process of building up the diagram can be described as a series of primitive unit steps, leading to a molecular connection table, with 2 D coordinates for each atom .In this work, we will explore an alphabet of primitives which has been chosen for the following properties:- small number of operation types- minimal degrees of freedom for input- opportunities for automated inferenceThe primary motivation for abstracting the sketching process in such a way is the emergence of new hardware devices which are highly constrained in terms of user input, such as smartphones, tablets and netbooks. These devices often lack an accurate pointing device. Mobile devices with touch screens, for example, are effective for selecting objects, but they are much less effective for the precise positioning operations upon which conventional molecule drawing software relies. Mobile devices which lack a touch screen offer merely a keypad and directional cursor keys.By describing all of the unit primitives needed to produce a molecular structure diagram in such a way that none of them requires precise user-supplied position information, structure sketching becomes possible for environments in which the user input is limited to little more than a series of menu choices.The objective of this work is to describe a collection of primitive drawing operations which provides a comprehensive set of editing capabilities. These can be used to compose complex diagrams with minimal effort on behalf of the operator.Ideally, each primitive would be able to examine the molecule diagram thus far, determine what it is the user wants changed, and execute the change. In practice, several additional fields are required for most operations. The unit primitives which are described in this work operate as sequences of:subject- select action- select result- select subject is an annotation to the existing structure, which consists of:The - current atom or current bond- a set of selected atomssubject atoms is defined as a set of:At any time there may be a current atom or a current bond, but not both. Each atom of the existing structure is either selected or unselected. In the text that follows, the term - all selected atoms, if there are any;or: the current atom, if there is one;- or: the two atoms of the current bond, if there is one;- else: an empty set.- action is the choice of primitive to apply to the current subject.The results. The list of results should be sorted so that the most plausible result is first, and the remaining possibilities in order of decreasing relevance.For many primitives, there is just one possible outcome when applied to a particular subject, e.g. changing atoms to a specific element, for which it is appropriate to design the primitive to have an unambiguous effect. For some of the more complicated primitives, there could be more than one possible outcome, e.g. attaching a template with multiple possible geometries. In these cases, the primitive may choose to generate a number of When this scheme is mapped to a practical implementation of a user interface, the sequence can be described as:- select the atoms or bonds of interest- pick the action from a menu- if there is more than one result, and the best suggestion is not the desired one, pick from the list of possibilitiesThe remainder of this section describes a minimal set of primitive classes which provide enough functionality to assemble a fully-featured molecular drawing package.Atom modification primitives are mostly straightforward and unambiguous, such as changing an element label, or altering atom-centred properties such as charge or radical count. The number of primitives required depends on the number of editable atom properties used to describe the molecular structure. The following primitive classes are representative.A new atom is created. Its position is determined automatically. If the structure already contains one or more atoms, it is along the top and to the right of the existing atoms.One primitive is required for each element of the periodic table. The new atom will have the corresponding label, with default values for all other properties, and no bonds.Add Atom primitive.The subject atoms have their atomic symbol changed. One primitive is required for each element of the periodic table. If there is no subject, then this primitive should be mapped to the corresponding Variations on this primitive should allow arbitrary values to be entered via an input dialog, for symbols which are not atomic elements, such as abbreviations or Markush structures.The subject atoms have their ionic charge set to a specific value, such as 0, -1, +1, etc. The primitives in this class can either specify exact values for the charge, or they can be increment/decrement operations.radical count) set to a specific value, where 0 is for diamagnetic atoms, 1 is for radicals, 2 is for carbene-like species, etc. One primitive is needed for each available value.The subject atoms have the number of unpaired electrons .New Bond with Order, in the Geometry section, which creates a new atom and a new bond.If the subject contains a single atom, this primitive is mapped to If the subject contains two atoms, and they are not currently bonded to each other, a new bond with the requested order is added between them.Otherwise, all bonds between any two atoms within the subject set are set to the indicated bond order. Any of these bonds which previously had a specific stereo style is reset to the default non-stereochemical bond type.This class contains one primitive for each explicit bond stereo-style supported by the molecular datastructure, which includes: inclined bonds (upward wedge); declined bonds (hashed wedge); and unknown stereochemistry (often drawn as a wavy line). When used correctly, these types are sufficient to unambiguously resolve most kinds of stereoisomerism.Set Bond Order class, if the subject contains a single atom, this primitive is mapped to New Bond with Stereo Style, in the Geometry section.Similarly to the If the subject contains two atoms which are not currently bonded to each other, a new bond of order 1 and the indicated stereo style is created. In the case of inclined or declined wedge bonds, the direction is arbitrary, and is defined by the current atom order.Otherwise, all bonds between any two atoms within the subject set become the focus of the operation: the bond stereo style is set to the indicated type. If the indicated type is inclined or declined, then any of the affected bonds which are already of this type have their  order reversed, which inverts the meaning of the wedge, potentially altering the stereochemistry.Of all the subject atoms, any pairwise combination of two atoms which are not already bonded is considered. If there are any such atom pairs whose bond distances are approximately within the default bond distance (see Appendix 1) then all of these pairs are joined by adding a single bond between each pair.If there are unbonded pairs, but none of them are close enough to the default bond distance, then only the closest pair of atoms is connected.Any bond for which both the participating atoms are a part of the subject is deleted. The atoms themselves are not otherwise modified.Removal of atoms and bonds is straightforward, and requires only a small amount of logic to interpret the subject and apply the action to the molecule connection table.All of the atoms in the subject set are deleted, as are any bonds which are connected to them.Any bond which is between two atoms within the subject set is deleted. The atoms themselves are not modified.All atoms and bonds are deleted.Each atom in the subject set is examined to see if it is particularly close to any other atom in the structure, typically set to a tolerance level which is significantly shorter than the default bond distance (see Appendix 1). For each of the subject atoms, a list is made of all other atoms to which the distance falls within the tolerance. From this list, one atom is selected to be retained, using the merging rules described in Appendix 2. The coordinates of the retained atom are set to the average position of the atoms in the list.While the unit primitives for grafting new fragments onto an existing molecular sketch are entirely sufficient for building up many complex molecules, there will always be structures which need to be fine tuned, or drawn with nonstandard parameters. This is often the case around heavily congested atoms for which there is no non-overlapping planar layout that adheres to common conventions.Detailed control over individual atom positions is straightforward to implement, but care is needed to ensure that the primitives accomplish common tasks with a minimal number of invocations.The subject atoms are moved in a specific direction. There are twelve primitives in this class: four directions  by three extents .The small and large nudges offset the X or Y coordinates of the subject atoms in the given direction by an offset, such as 0.1 or 0.5 \u00c5.When moving to the furthest extent, the distance needed to move the subject atoms 1 \u00c5 beyond any of the other atoms in the molecule is calculated, and used as the offset.Two primitives are defined for this class: grow and shrink, which correspond to scaling factors of 1.25 and 0.8, respectively.If the subject contains any selected atoms, then a central point is determined from the average positions of the selected atoms, unless there is also a current atom or bond, in which case its central position is used instead. Each of the subject atoms has its position recalculated by scaling its distance from the central point by the scaling factor associated with the primitive.Scale Bond primitive.If there are no selected atoms, but there is a current bond, then this primitive is mapped to the corresponding Scale Atoms class, two primitives are defined: grow and shrink, which correspond to scaling factors of 1.25 and 0.8, respectively.As for the The subject must include two atoms which are bonded to each other. Each side of the bond is assigned a weighting of 0, 0.5 or 1.If the bond is acyclic, then the atoms of the connected components on either side of the bond are counted. If one side forms a component with more atoms than the other, then the smaller side is assigned a weighting of 1 and the larger side a weighting of 0. If both sides have the same size, or the bond is cyclic, then both sides are assigned a weighting of 0.5.The bond length is scaled according to the scaling factor assigned to the primitive, and the weights that are assigned to both sides, i.e. if a side has a weighting of 0 it does not move. For acyclic bonds, when moving one side of the bond, all other atoms associated with that side are moved as well. For cyclic bonds, only the two atoms that make up the bond are extended.Figure Two primitives are defined for this class: horizontal and vertical flip.If the subject contains some number of selected atoms, then these atoms are flipped about the indicated axis. The origin of the axis is calculated as the average position of the selected atoms, unless there is also a current atom or bond, in which case its central position is used instead.If the subject only contains a current atom or bond, then the whole connected component is used as the subject. If the subject is empty, then all atoms are used as the subject.Primitives in this class are defined to be common rotation increments, such as \u00b1 1\u00b0, \u00b1 5\u00b0, \u00b1 15\u00b0 and \u00b1 30\u00b0.The position of the rotation centre is determined by the average position of the selected atoms, unless there is also a current atom or bond, in which case its central position is used instead. A further special case is defined: if there are no selected atoms, but there is a current bond, and one end of the bond is terminal, then the terminal atom is rotated about the position defined by the non-terminal end of the bond.Because the information provided to the unit primitives cannot include spatial information such as bond direction, a crucial part of the design of the primitives is based on perception of atom geometry.One of the most important sketching primitives is the ability to create a new atom which is bonded to an existing atom. With a traditional user interface this is done by using the mouse to drag a bond line in a particular direction, thus specifying bond angle and distance. Lacking such input, it is necessary for algorithms to be able to estimate the geometry of the atom, and from it, the most likely directions for a new bond.Fortunately there are only a handful of geometry templates which are commonly observed in molecular diagrams, for atoms in environments which are not constrained by rings or heavy congestion. In this work, seven geometry templates are used. These are shown in Figure Most atom environments, when unconstrained, are drawn with complete or partial occupancy of one of these geometries. By examining the immediate bonding environment of an atom, it is often possible to make a reasonable estimate as to which of these geometry templates is most appropriate - and more importantly, which would be most appropriate in the context of adding an additional bond to a new atom. The process of assigning probable geometry based on topology and partial geometry is explained in Appendix 3.When creating a new bond with a known bond order, the first step is to consider the subject atom with an additional bond with the requested order, connected to a newly created neutral carbon atom. In its new circumstances, the subject atom may have some number of preferred geometries. Consider the following cases shown in Figure In the examples shown in Figure Appendix 3 describes in detail the process of determining potential new bond angles. Once the list of angles has been generated, it is necessary to select one. For each of the angles, a point position is calculated by extending to the default bond length. The molecular congestion at each of these points is calculated (see Appendix 4), and the point which has the lowest congestion is used. A new carbon atom is created at this position, and a bond is created between the subject atom and the new atom.New Bond with Order, given that the bond order is 1. The newly created bond has the indicated stereochemical style, e.g. inclined, declined or unknown. For wedge bonds, the atom direction emanates from the subject atom.The new atom position is determined using the same method as for This class has one primitive for each of the 7 available geometries, which are shown in Figure New Bond with Order, but more specific: if the current geometry about the subject atom does not match the indicated geometry with one angle missing, then the operation will instead be mapped to the corresponding Set Geometry primitive. If it does match, then all of the angles which are implied by matching the partial geometry are scored by calculating the congestion at the point of the implied new atom (see Appendix 4). The angle which corresponds to an atom with the least congestion is used to create the new atom and bond.The implementation is related to that of This class has one primitive for each of the 7 available geometries, as shown in Figure Each of the subject atoms is examined in the context of the requested geometry type. If the current geometry about the atom matches the requested geometry, with some number of missing bonds, then this primitive has no effect. If a partial match is not possible, the geometry about the atom will be refitted, if possible, in order to make it compliant with the requested geometry.New Bond with Geometry. In Figure This primitive class is complementary with For each pairwise combination of an existing bond and a bond from the geometry template, the template is rotated so that the two angles match. Of the remaining existing bonds, the angles are rotated so that they align with the closest angle from the rotated geometry template.Cases which require moving of a bond which is part of a ring system are disallowed. If there are multiple ways to refit the geometry, that with the smallest overall angular displacement is chosen. If the geometry template is asymmetric, the process is repeated with its mirror image.One of the caveats of the methods by which the primitives select a new bond geometry is that there are often multiple choices which are quite similarly valid. Selecting the least congested position is the desired result more often than chance, but it is not uncommon for a more congested position to be preferred.For this primitive, the subject must indicate a bond, and only one side of the bond must be terminal. The non-terminal end of the bond is examined, and its most likely bond geometry is estimated, as if the selected bond were not present (see Appendix 3). If no compatible geometry is found, or the only compatible geometry contains no available positions, this operation is not carried out.Any missing angles, which are non-degenerate and differ from the original bond angle, are considered to be viable new angles for the selected bond. Two examples are shown in Figure The grafting of predefined template fragments onto an existing molecular structure is a vital part of the sketching process. Chemical structures include a number of diagram motifs which occur throughout the field, e.g. small rings of sizes 3 through 6 are all but ubiquitous, and rings which are neither square nor hexagonal are difficult to draw precisely. Besides rings and fused ring systems, there are a number of chains, branched chains, larger rings and functional groups which are particularly common. Almost all molecule structure drawing software has some number of predrawn templates, which can be added to the structure as a separate component, or attached to an existing component. Suggested default templates can be found in the Supplementary Information.With a few exceptions, the algorithms needed for fusing an arbitrary structure with an arbitrary template fragment are non-trivial. Given the information allocated to the unit primitives described in this work, it is possible to specify information about the attachment site on the current structure, but not any information about which part of the template itself should be involved in the joining process.Because practicing chemists often work on a series of projects for which particular structural motifs are frequently encountered, but not all of them are common throughout chemistry as a whole, it is also important to ensure that the list of available templates can be extended easily.copy and cut actions that have become a standard part of the desktop metaphor place a single template onto the clipboard, and paste reads the template back out and applies it, using the same algorithm as is used for grafting predefined templates. The clipboard therefore shares the same primitive classes as the template functionality.A standard convenience feature made available by almost all molecular drawing programs is the ability to copy portions of the current molecule onto a temporary container, often referred to as the clipboard, then paste them back later. For the purposes of this work, the clipboard should be considered as a single temporary template, i.e. the This primitive class describes two operations: copying a molecular fragment to a temporary container, such as the system clipboard, and copying a molecular fragment to a persistent collection of fragments, such as a group of templates.The template fragment itself is generated by considering the subject atoms to define a substructure, which is excised from the current structure.If the subject atoms make up whole connected components, i.e. they are not bonded to any atoms which are not part of the subject, then the template fragment is taken to be the substructure in its entirety.guide atoms for the primitive classes which make use of them, which is described below.Otherwise, all atoms which are immediately connected to one or more of the subject atoms are also included in the template fragment, but have their atom type converted into a placeholder atom label. In the examples shown in Figure A logical primitive is defined for each template that is available to the user, including the clipboard, if it contains a suitable molecular structure. The template fragment is an implicit parameter of the primitive. When the operation is instigated, several classes of behaviour will be investigated, depending on the nature of the template fragment and the subject.The objective of the grafting procedure is to produce a list of putative new structures, each of which is a plausible way in which the template might be appended to the existing structure. Each of the following primitive classes is given an opportunity to generate some number of potential new structures, if appropriate.guide atoms. The presence of these atoms introduces opportunities for special behaviour. Using guide atoms is a way to reduce the degrees of freedom when it comes to the possible types of outcomes, which is useful when a template was designed with the intention of using a specific attachment mode. It is also necessary when the attachment modes favour nonstandard bond distances or angles, which would not ordinarily be generated by the geometry perception algorithms.As described previously, templates may have special When there are no subject atoms, adding a template to the current structure is straightforward. It needs to be placed in an area where its atoms and bonds do not interfere with any that already exist, e.g. to the right and centre of the current structure.All possible rotations of increments of 30\u00b0 and 45\u00b0 are included in the list of output structures. If the template contains guide atoms, they are stripped out.If there is one subject atom, this primitive applies. If the template contains guide atoms, they are stripped out.New structures are generated using the following overall sequence:Mirror to be the mirror image equivalent of the Template.1. Define N, in the template fragment.2. Loop over each atom, Template, N}.3. Direct Connect {Mirror, N}.4. Direct Connect {Template, N}.5. Bridge Connect {Mirror, N}.6. Bridge Connect {let x = -x. If there are any bonds with inclined or declined stereochemistry, these are interchanged.The connections are repeated with the mirror image of the template structure, in case it is not symmetrical. Generation of the mirror image is done by inverting one of the axes, e.g. N) of the template fragment, and finding suitable angles by which to rotate the fragment. Bridge connection involves creating a new bond between the two atoms, rather than mapping them onto each other.There are two main methods used for grafting templates using a single atom as the frame of reference. Direct connection involves overlaying the subject atom of the initial structure with the iterated atom . The template fragment is translated so that atom N is superimposed on top of the subject atom from the starting structure. The template fragment is rotated by \u03b81-\u03b82+180\u00b0, about the atom N. The two fragments are then combined, and the result recorded.Both sets of angles are iterated over .3. Loop over each atom, 1 Nso that the direction of the 1N2 Nvector matches that of the first two subject atoms.4. Rotate the template fragment about 5. Match all remaining atoms.In step 4, the position of the first subject atom is used as the axis of rotation, so that the directions of the first two atoms are aligned. In the example shown in Figure 2 Nfrom the template fragment does not now overlap the position of the second subject atom, then the graft is rejected. Once the first two atoms are aligned and matched, the remaining subject atoms are each required to overlap with one of the template atoms. If any of them do not, the graft is rejected.If the position of the atom Once all of the atoms are matched, the fragments are merged, as described in Appendix 2, and a new structure is added to the list.If there is one subject atom, and the template contains one guide atom, and the guide atom has one adjacent neighbour, this primitive applies.bridge connect variant of the Graft with Atom Connection primitive, except with less degrees of freedom, because there is only one applicable template atom, and the projection direction and magnitude is defined by the guide atom.Grafting a template containing a single guide atom to a single subject atom has a similar effect to the The list of projection angles emerging from the subject atom is calculated. These angles are matched against the angle formed from the guide to its neighbour. In the example shown in Figure The bond distance is taken from the distance between the guide atom and its neighbour, rather than using the default bond distance. As with the other grafting primitives, the process is repeated with the mirror image of the template fragment. Once the grafting is complete, the bond connecting the guide atom to the rest of the template fragment is attached to the subject atom, and the guide atom is deleted. The remaining atoms are merged together if there is any overlap.The main benefit of this primitive arises when a template is to be affixed using an irregular or non-obvious geometry, but it is also a way to ensure that a specific template connection point is used preferentially.If there are two subject atoms, and they are bonded to each other, and the template contains one guide atom, and the guide atom has one adjacent neighbour, this primitive applies.The template grafting is done by mapping the subject bond and the template fragment bond to each other. There are 4 base permutations, obtained by using the template fragment vs. its mirror image, and aligning the matched bonds in both parallel and anti-parallel fashion.There is a further bifurcation if the two bonds differ in length: in one case the guide atom is mapped onto the first subject atom, and in the other case the atom adjacent to the guide atom is mapped onto the second subject atom, which is illustrated in Figure Graft with One Guide Atom primitive, because both of the connection angles and the bond distance can be defined prior to the grafting process, which is particularly useful if the subject contains an irregular geometry or nondefault bond distance.This primitive is useful as a constrained case of the If there is at least one subject atom, and the template contains at least one guide atom, this primitive applies in the following cases:1. There is one subject atom and one guide atom, and the guide atom has more than one neighbour.2. There are 2 or more subject atoms, and the number of guide atoms is equal to the number of subject atoms.Graft with One Guide Atom primitive. Bond angle projections are generated from the source atom. For the template fragment, a median angle is generated, by considering the angles between the guide atom and the atoms adjacent to it. In the example shown in Figure The first case is dealt with in a similar way to the Graft with Multiple Connections, except that the guide atoms are used to map the template fragment. As shown in Figure The second case is handled using the same technique as for When any successful matches are found, in which all of the guide atoms can be mapped onto a subject atom, the structures are merged together and the guide atoms are deleted.After each of the primitives described above has had its chance to generate some number of putative new structures, the result list is processed. First, the list is trimmed such that whenever any two structures are found to be equivalent, one of the structures is removed from the list. The method used to decide whether two structures are equivalent is described in Appendix 5.Once the unique set of structures is obtained, they must then be scored. The objective of scoring is to present the most feasible fused structures first, such that the user is most likely to see the desired result presented first and foremost. In cases where it is clear that some structures are significantly more reasonable than others , then some of the results can be omitted.The score for each grafted template result is computed by adding the following terms, where lower is better:1. The total congestion of the molecule (see Appendix 4).2. +1 for each atom that was merged with another atom due to positional overlap.3, sp2 or sp hybridised, and received a new bond which was not positioned at an angle 120\u00b0 (sp3 and sp2) or 180\u00b0 (sp) from its neighbours, with a tolerance of 5\u00b0.3. +50 for each atom of element type C, N, O, P or S which is clearly sp4. +1000 for every carbon or nitrogen atom with a total bond order of 5 or more.5. -1 for every guide atom involved in the grafting process.The scoring system heavily favours regular bond angles, prefers to add new atoms in less congested orientations, and encourages avoidance of certain types of impossible structures.If the best available structure has a score of less than 1000, then all structures with a score of 1000 or more are excluded.Once the scoring is complete, the structures are ordered so that the results with the lowest scores are shown first. For user interface purposes, it is appropriate to allow the user to traverse the list of potential structures, and select the desired result, if there is more than one. The best scoring result is frequently the intended result of the operation.The unit primitives which have been described thus far provide a way to draw or modify structure diagrams with a small number of steps and a much lower input bandwidth than would be required from a conventional software package which relies on a pixel-perfect pointing device, such as a mouse or trackpad. The following examples illustrate the steps required in order to draw three molecules from scratch, using the primitives described in this work.The first example, shown in Figure Graft with No Connections: benzenea. New Bond with Order: 1b. New Bond with Order: 2c. Switch Geometryd. New Bond with Order: 1e. Set Element Label: Of. New Bond with Order: 1g. Set Element Label: Oh. Graft with Atom Connection: acetyli. ingenol [The natural product ingenol  can be dGraft with No Connections: cycloheptanea. Graft with Multiple Connections: cycloheptaneb. Delete Atomsc. Graft with Bond Connection: cyclopentaned. Graft with Bond Connection: cyclopropanee. New Bond with Order: 2f. Flip Atoms: vertical. Note that the two atoms making up the double bond are selected, while the source of the terminal bond is the current atom.g. Set Stereo Style: inclinedh. Set Stereo Style: inclined. Note that this reverses the direction of the already extant wedge.i. Set Bond Order: 2j. New Bond with Order: 1k. New Bond with Stereo Style: inclinedl. New Bond with Stereo Style: declinedm. New Bond with Geometry: tetrahedral (variant #1). Note this primitive is issued twice, in order to create two new bonds.n. New Bond with Order: 1o. Set Element Label: Op. Set Element Label: Hq. The gold-based catalytic intermediate for a carboxylation reaction  is drawnGraft with Atom Connection: cyclopropanea. Set Bond Order: 2b. Set Element Label: Nc. New Bond with Order: 1d. Graft with Atom Connection: benzenee. New Bond with Stereo Style: declinedf. New Bond with Stereo Style: inclinedg. New Bond with Order: 1. Note this primitive is issued twice, in order to create two new bonds for each of the selected atoms.h. Create Template: copy to clipboard.i. Graft with One Guide Atom: paste from clipboard.j. Scale Atoms: growk. New Bond with Geometry: linearl. Set Element Label: Om. New Bond with Geometry: linearn. Graft with Bond Connection: acetylo. Graft with Atom Connection: cyclopentadienep. Set Element Label: Nq. Set Element Label: Or. A collection of unit primitives for sketching molecular diagrams has been described. It is complete, such that complex molecules can be drawn by stringing together a series of these primitives. It is efficient, insofar as the more regular components of a chemical structure can be drawn using a small number of primitives, since only a very small amount of information must be transmitted from the user in order for the algorithms to infer the intent. Less regular features can be created by manipulating atom positions or angles using a variety of low level primitives, but a number of implicit shortcuts can be exploited to keep repetitive actions to a minimum.Several representative examples have been shown, which illustrate the relatively small number of steps and low information content necessary to draw complex molecular geometries, and obtain publication-quality depiction layout coordinates.The primitives described in this work provide the tools needed to build a user interface in which input is limited to selecting atoms and picking from menu choices. The interface can expose the primitives by several means, such as menu bars, icon toolbars, keyboard shortcuts, etc. As long as all of the primitives are conveniently available, the user interface will provide a complete and efficient molecule drawing tool.These primitives have been implemented in a commercial software product called the Mobile Molecular DataSheet (MMDS), which is available for BlackBerry smartphones and iPhone/iPod/iPad devices . Both veWhile the motivation for this work arose from the need to provide molecular sketching capabilities on mobile devices with tiny screens and lack of accurate pointing devices, the set of primitives has applicability outside of this niche.One analogous situation is found in web-based applications where the capabilities of the browser must be assumed to be a lowest common denominator, which requires that the web server do most of the work . Under tde novo series [The primitives described in this work were designed for the purpose of using them to compose a user interface, but they may find applicability as part of scripted processes. For example, when producing a series of chemical structures as part of a combinatorial library ,21 or soo series -24, it mBecause a molecular sketch does not correspond to a physical model, the 2 D coordinates of the atoms are chosen so that they can be presented on a screen or a piece of paper, in such a way that chemists can quickly perceive the structural features and be able to ascertain stereochemistry from the layout and additional annotations.The choice of units for the coordinates is arbitrary, but in this work, Angstroms are used. The default unit of distance between any two atoms is 1.5 \u00c5, which applies regardless of atom and bond type.overlapping. Some of the algorithms described in this work consider overlapping atoms as a cue to merge two atoms together. Otherwise, the presence of overlapping atoms is generally considered to be an error state, since this makes visual perception of a diagram difficult.Any two atoms that are closer than 0.2 \u00c5 are considered to be The template grafting algorithms described in this work mostly operate by joining specific atoms together. While these atoms are merged, bonded or deleted according to the algorithm, there is also the possibility for additional atoms to overlap. This situation is dealt with according to the following steps.The composite structure is partitioned into its two sources, i.e. atoms that originated from the starting structure, and atoms that originated from the grafted fragment. Pairwise combinations of these atoms are examined to see if they overlap. When an overlap is found, one atom must be retained, and the other atom deleted. Before the other atom is deleted, its bonds must be reassigned to the retained atom.exotic each atom is, which is calculated by assigning one point for each condition that applies:The decision as to which atom to retain is made based on how - Having an element label other than carbon- Non-zero charge- Any unpaired electrons- Non-default isotope abundance- Specific non-automatic hydrogen countThe most exotic atom is retained, or the first one, if they are equally so.exoticness of a bond is assigned by one point for each of:During the merging process, it is possible to create duplicate bonds. A similar process is used to decide which bond to keep. The - Bond order other than 1- Any stereochemical assignmentAs for atoms, the first bond is retained in the event of a draw.Other primitives besides template grafting also have need to merge together atoms which happen to overlap. In these cases the same procedure is used, but without the partitioning.For many of the primitives described in this work, it is necessary to produce a list of potential angles for a new bond that will be created with a particular source atom and bond order in mind. When the list of angles produced contains the result which is desired by the user, the amount of effort required to draw the structure is considerably reduced.The following sequence is used to obtain a list of potential new bond angles:1. If the atom is isolated, return four angles, aligned on the X and Y axes.2. Match the atom's bond topology to likely geometry templates , classify as either s-block atoms, classify as either trigonal, square planar or either of the octahedral geometries.b. For trigonal, square planar or either of the tetrahedral geometries.c. If the atom is carbon, and the bonds are all single, classify as either trigonal.d. If the atom is carbon, and the bonds are not all single, classify as p-block, and in the first 3 rows, classify as being trigonal, either of the tetrahedral geometries, or square planar.d. If the atom is in the p-block, but not in the first 3 rows, classify as being any of the available geometries.f. If the atom is in the octahedral geometries.g. Otherwise, classify as either of the two Once the possible classifications have been enumerated, each of them is checked to see if there is any way the current geometry can match it, within a tolerance of 2\u00b0. The first postulated geometry to achieve a match is given precedence. All of the nondegenerate vacant bond directions implied by the ways in which it can match the input structure are returned as the resulting list of possible new bond geometries.If no matches were found, the list of current bond angles are sorted by bond angle. For each bond, the angle directly in between itself and the next angle in the list  is calculated and added to the result list.congestion to make decisions about where to place a new atom, bond or fragment, when an otherwise degenerate choice is available. The position which places new atoms as far away as possible from existing atoms is frequently preferable to the alternatives.A number of the primitives use The congestion at a specific point is calculated by:i iterates over each atom in the structure, and x and y denote the atomic position, where the subscripted variables are the positions of existing atoms.where The total congestion of a molecule is calculated by:i and j iterate over all unique pairs of atoms.where Two structures A and B are considered equivalent or not according to the following algorithm:1. If the number of atoms or bonds is different, the structures are different.2. The structures are translated so that their centre positions are the same. Each atom in structure A is mapped uniquely to the closest atom in structure B, which must be within 0.2 \u00c5.3. If any atoms are not successfully mapped, the structures are different.4. Every atom in structure A must be mapped to an atom in structure B which has the same element label, charge, unpaired electron count, etc. If any mapped pair of atoms are not the same, the structures are different.a1 and a2, there must be a corresponding bond in structure B, between atoms b1 and b2, where a1:b1 and a2:b2 are mapped to each other. If the bond stereochemistry type is not a wedge bond (inclined or declined), the inverse mapping, a1:b2 and a2:b1, is also permitted. If no such pair can be found, the structures are different. The matched bonds must have the same order and stereochemistry type. If not, the structures are different.5. For every bond in structure A, between atoms 6. If no differences were found, the two structures are equivalent.This comparison considers alternate tautomers and Kekul\u00e9 resonance forms to be different species, which is desirable for sketching purposes. The determination of the equivalence of two sketches, as described above, should not be confused with methods used to determine whether two connection tables represent the same molecule, such as unique SMILES  or InChIA list of template fragments grouped into categories is provided [Additional file Additional examples of diagram drawing using the primitives described in this work can be found online .The author is the founder and president of Molecular Materials Informatics, Inc., which produces the Mobile Molecular DataSheet, a working implementation of the primitives described in this manuscript. This publication is a disclosure of the algorithms that form the basis of a commercial product.Suggested default template fragments. A printable document containing diagrams of template fragments.Click here for fileSuggested default template fragments (SD files). A collection of MDL SD files, one per group, containing machine-readable data for each of the template fragments.Click here for file", "texts": ["A collection of primitive operations for molecular diagram sketching has been developed. These primitives compose a concise set of operations which can be used to construct publication-quality 2 D coordinates for molecular structures using a bare minimum of input bandwidth. The input requirements for each primitive consist of a small number of discrete choices, which means that these primitives can be used to form the basis of a user interface which does not require an accurate pointing device. This is particularly relevant to software designed for contemporary mobile platforms. The reduction of input bandwidth is accomplished by using algorithmic methods for anticipating probable geometries during the sketching process, and by intelligent use of template grafting. The algorithms and their uses are described in detail. Molecular structure diagrams have been the mainstay of chemical communication since molecules began to be rationalised as Lewis structures. The basic ideas involved in representing structures have proven to be remarkably resilient -3. WhileIn recent decades, the process of creating molecular structure diagrams has steadily shifted towards use of computer software, which is now used exclusively for publications, and is in the process of replacing hand-drawings by way of electronic lab notebooks . There iThe subject of this work is a slightly different perspective on the drawing of a 2 D molecular structure diagram. Assuming that the composition of the molecule is known, and the desired output is an arrangement of atoms and bonds onto a flat surface, the process of building up the diagram can be described as a series of primitive unit steps, leading to a molecular connection table, with 2 D coordinates for each atom .In this work, we will explore an alphabet of primitives which has been chosen for the following properties:- small number of operation types- minimal degrees of freedom for input- opportunities for automated inferenceThe primary motivation for abstracting the sketching process in such a way is the emergence of new hardware devices which are highly constrained in terms of user input, such as smartphones, tablets and netbooks. These devices often lack an accurate pointing device. Mobile devices with touch screens, for example, are effective for selecting objects, but they are much less effective for the precise positioning operations upon which conventional molecule drawing software relies. Mobile devices which lack a touch screen offer merely a keypad and directional cursor keys.By describing all of the unit primitives needed to produce a molecular structure diagram in such a way that none of them requires precise user-supplied position information, structure sketching becomes possible for environments in which the user input is limited to little more than a series of menu choices.The objective of this work is to describe a collection of primitive drawing operations which provides a comprehensive set of editing capabilities. These can be used to compose complex diagrams with minimal effort on behalf of the operator.Ideally, each primitive would be able to examine the molecule diagram thus far, determine what it is the user wants changed, and execute the change. In practice, several additional fields are required for most operations. The unit primitives which are described in this work operate as sequences of:subject- select action- select result- select subject is an annotation to the existing structure, which consists of:The - current atom or current bond- a set of selected atomssubject atoms is defined as a set of:At any time there may be a current atom or a current bond, but not both. Each atom of the existing structure is either selected or unselected. In the text that follows, the term - all selected atoms, if there are any;or: the current atom, if there is one;- or: the two atoms of the current bond, if there is one;- else: an empty set.- action is the choice of primitive to apply to the current subject.The results. The list of results should be sorted so that the most plausible result is first, and the remaining possibilities in order of decreasing relevance.For many primitives, there is just one possible outcome when applied to a particular subject, e.g. changing atoms to a specific element, for which it is appropriate to design the primitive to have an unambiguous effect. For some of the more complicated primitives, there could be more than one possible outcome, e.g. attaching a template with multiple possible geometries. In these cases, the primitive may choose to generate a number of When this scheme is mapped to a practical implementation of a user interface, the sequence can be described as:- select the atoms or bonds of interest- pick the action from a menu- if there is more than one result, and the best suggestion is not the desired one, pick from the list of possibilitiesThe remainder of this section describes a minimal set of primitive classes which provide enough functionality to assemble a fully-featured molecular drawing package.Atom modification primitives are mostly straightforward and unambiguous, such as changing an element label, or altering atom-centred properties such as charge or radical count. The number of primitives required depends on the number of editable atom properties used to describe the molecular structure. The following primitive classes are representative.A new atom is created. Its position is determined automatically. If the structure already contains one or more atoms, it is along the top and to the right of the existing atoms.One primitive is required for each element of the periodic table. The new atom will have the corresponding label, with default values for all other properties, and no bonds.Add Atom primitive.The subject atoms have their atomic symbol changed. One primitive is required for each element of the periodic table. If there is no subject, then this primitive should be mapped to the corresponding Variations on this primitive should allow arbitrary values to be entered via an input dialog, for symbols which are not atomic elements, such as abbreviations or Markush structures.The subject atoms have their ionic charge set to a specific value, such as 0, -1, +1, etc. The primitives in this class can either specify exact values for the charge, or they can be increment/decrement operations.radical count) set to a specific value, where 0 is for diamagnetic atoms, 1 is for radicals, 2 is for carbene-like species, etc. One primitive is needed for each available value.The subject atoms have the number of unpaired electrons .New Bond with Order, in the Geometry section, which creates a new atom and a new bond.If the subject contains a single atom, this primitive is mapped to If the subject contains two atoms, and they are not currently bonded to each other, a new bond with the requested order is added between them.Otherwise, all bonds between any two atoms within the subject set are set to the indicated bond order. Any of these bonds which previously had a specific stereo style is reset to the default non-stereochemical bond type.This class contains one primitive for each explicit bond stereo-style supported by the molecular datastructure, which includes: inclined bonds (upward wedge); declined bonds (hashed wedge); and unknown stereochemistry (often drawn as a wavy line). When used correctly, these types are sufficient to unambiguously resolve most kinds of stereoisomerism.Set Bond Order class, if the subject contains a single atom, this primitive is mapped to New Bond with Stereo Style, in the Geometry section.Similarly to the If the subject contains two atoms which are not currently bonded to each other, a new bond of order 1 and the indicated stereo style is created. In the case of inclined or declined wedge bonds, the direction is arbitrary, and is defined by the current atom order.Otherwise, all bonds between any two atoms within the subject set become the focus of the operation: the bond stereo style is set to the indicated type. If the indicated type is inclined or declined, then any of the affected bonds which are already of this type have their  order reversed, which inverts the meaning of the wedge, potentially altering the stereochemistry.Of all the subject atoms, any pairwise combination of two atoms which are not already bonded is considered. If there are any such atom pairs whose bond distances are approximately within the default bond distance (see Appendix 1) then all of these pairs are joined by adding a single bond between each pair.If there are unbonded pairs, but none of them are close enough to the default bond distance, then only the closest pair of atoms is connected.Any bond for which both the participating atoms are a part of the subject is deleted. The atoms themselves are not otherwise modified.Removal of atoms and bonds is straightforward, and requires only a small amount of logic to interpret the subject and apply the action to the molecule connection table.All of the atoms in the subject set are deleted, as are any bonds which are connected to them.Any bond which is between two atoms within the subject set is deleted. The atoms themselves are not modified.All atoms and bonds are deleted.Each atom in the subject set is examined to see if it is particularly close to any other atom in the structure, typically set to a tolerance level which is significantly shorter than the default bond distance (see Appendix 1). For each of the subject atoms, a list is made of all other atoms to which the distance falls within the tolerance. From this list, one atom is selected to be retained, using the merging rules described in Appendix 2. The coordinates of the retained atom are set to the average position of the atoms in the list.While the unit primitives for grafting new fragments onto an existing molecular sketch are entirely sufficient for building up many complex molecules, there will always be structures which need to be fine tuned, or drawn with nonstandard parameters. This is often the case around heavily congested atoms for which there is no non-overlapping planar layout that adheres to common conventions.Detailed control over individual atom positions is straightforward to implement, but care is needed to ensure that the primitives accomplish common tasks with a minimal number of invocations.The subject atoms are moved in a specific direction. There are twelve primitives in this class: four directions  by three extents .The small and large nudges offset the X or Y coordinates of the subject atoms in the given direction by an offset, such as 0.1 or 0.5 \u00c5.When moving to the furthest extent, the distance needed to move the subject atoms 1 \u00c5 beyond any of the other atoms in the molecule is calculated, and used as the offset.Two primitives are defined for this class: grow and shrink, which correspond to scaling factors of 1.25 and 0.8, respectively.If the subject contains any selected atoms, then a central point is determined from the average positions of the selected atoms, unless there is also a current atom or bond, in which case its central position is used instead. Each of the subject atoms has its position recalculated by scaling its distance from the central point by the scaling factor associated with the primitive.Scale Bond primitive.If there are no selected atoms, but there is a current bond, then this primitive is mapped to the corresponding Scale Atoms class, two primitives are defined: grow and shrink, which correspond to scaling factors of 1.25 and 0.8, respectively.As for the The subject must include two atoms which are bonded to each other. Each side of the bond is assigned a weighting of 0, 0.5 or 1.If the bond is acyclic, then the atoms of the connected components on either side of the bond are counted. If one side forms a component with more atoms than the other, then the smaller side is assigned a weighting of 1 and the larger side a weighting of 0. If both sides have the same size, or the bond is cyclic, then both sides are assigned a weighting of 0.5.The bond length is scaled according to the scaling factor assigned to the primitive, and the weights that are assigned to both sides, i.e. if a side has a weighting of 0 it does not move. For acyclic bonds, when moving one side of the bond, all other atoms associated with that side are moved as well. For cyclic bonds, only the two atoms that make up the bond are extended.Figure Two primitives are defined for this class: horizontal and vertical flip.If the subject contains some number of selected atoms, then these atoms are flipped about the indicated axis. The origin of the axis is calculated as the average position of the selected atoms, unless there is also a current atom or bond, in which case its central position is used instead.If the subject only contains a current atom or bond, then the whole connected component is used as the subject. If the subject is empty, then all atoms are used as the subject.Primitives in this class are defined to be common rotation increments, such as \u00b1 1\u00b0, \u00b1 5\u00b0, \u00b1 15\u00b0 and \u00b1 30\u00b0.The position of the rotation centre is determined by the average position of the selected atoms, unless there is also a current atom or bond, in which case its central position is used instead. A further special case is defined: if there are no selected atoms, but there is a current bond, and one end of the bond is terminal, then the terminal atom is rotated about the position defined by the non-terminal end of the bond.Because the information provided to the unit primitives cannot include spatial information such as bond direction, a crucial part of the design of the primitives is based on perception of atom geometry.One of the most important sketching primitives is the ability to create a new atom which is bonded to an existing atom. With a traditional user interface this is done by using the mouse to drag a bond line in a particular direction, thus specifying bond angle and distance. Lacking such input, it is necessary for algorithms to be able to estimate the geometry of the atom, and from it, the most likely directions for a new bond.Fortunately there are only a handful of geometry templates which are commonly observed in molecular diagrams, for atoms in environments which are not constrained by rings or heavy congestion. In this work, seven geometry templates are used. These are shown in Figure Most atom environments, when unconstrained, are drawn with complete or partial occupancy of one of these geometries. By examining the immediate bonding environment of an atom, it is often possible to make a reasonable estimate as to which of these geometry templates is most appropriate - and more importantly, which would be most appropriate in the context of adding an additional bond to a new atom. The process of assigning probable geometry based on topology and partial geometry is explained in Appendix 3.When creating a new bond with a known bond order, the first step is to consider the subject atom with an additional bond with the requested order, connected to a newly created neutral carbon atom. In its new circumstances, the subject atom may have some number of preferred geometries. Consider the following cases shown in Figure In the examples shown in Figure Appendix 3 describes in detail the process of determining potential new bond angles. Once the list of angles has been generated, it is necessary to select one. For each of the angles, a point position is calculated by extending to the default bond length. The molecular congestion at each of these points is calculated (see Appendix 4), and the point which has the lowest congestion is used. A new carbon atom is created at this position, and a bond is created between the subject atom and the new atom.New Bond with Order, given that the bond order is 1. The newly created bond has the indicated stereochemical style, e.g. inclined, declined or unknown. For wedge bonds, the atom direction emanates from the subject atom.The new atom position is determined using the same method as for This class has one primitive for each of the 7 available geometries, which are shown in Figure New Bond with Order, but more specific: if the current geometry about the subject atom does not match the indicated geometry with one angle missing, then the operation will instead be mapped to the corresponding Set Geometry primitive. If it does match, then all of the angles which are implied by matching the partial geometry are scored by calculating the congestion at the point of the implied new atom (see Appendix 4). The angle which corresponds to an atom with the least congestion is used to create the new atom and bond.The implementation is related to that of This class has one primitive for each of the 7 available geometries, as shown in Figure Each of the subject atoms is examined in the context of the requested geometry type. If the current geometry about the atom matches the requested geometry, with some number of missing bonds, then this primitive has no effect. If a partial match is not possible, the geometry about the atom will be refitted, if possible, in order to make it compliant with the requested geometry.New Bond with Geometry. In Figure This primitive class is complementary with For each pairwise combination of an existing bond and a bond from the geometry template, the template is rotated so that the two angles match. Of the remaining existing bonds, the angles are rotated so that they align with the closest angle from the rotated geometry template.Cases which require moving of a bond which is part of a ring system are disallowed. If there are multiple ways to refit the geometry, that with the smallest overall angular displacement is chosen. If the geometry template is asymmetric, the process is repeated with its mirror image.One of the caveats of the methods by which the primitives select a new bond geometry is that there are often multiple choices which are quite similarly valid. Selecting the least congested position is the desired result more often than chance, but it is not uncommon for a more congested position to be preferred.For this primitive, the subject must indicate a bond, and only one side of the bond must be terminal. The non-terminal end of the bond is examined, and its most likely bond geometry is estimated, as if the selected bond were not present (see Appendix 3). If no compatible geometry is found, or the only compatible geometry contains no available positions, this operation is not carried out.Any missing angles, which are non-degenerate and differ from the original bond angle, are considered to be viable new angles for the selected bond. Two examples are shown in Figure The grafting of predefined template fragments onto an existing molecular structure is a vital part of the sketching process. Chemical structures include a number of diagram motifs which occur throughout the field, e.g. small rings of sizes 3 through 6 are all but ubiquitous, and rings which are neither square nor hexagonal are difficult to draw precisely. Besides rings and fused ring systems, there are a number of chains, branched chains, larger rings and functional groups which are particularly common. Almost all molecule structure drawing software has some number of predrawn templates, which can be added to the structure as a separate component, or attached to an existing component. Suggested default templates can be found in the Supplementary Information.With a few exceptions, the algorithms needed for fusing an arbitrary structure with an arbitrary template fragment are non-trivial. Given the information allocated to the unit primitives described in this work, it is possible to specify information about the attachment site on the current structure, but not any information about which part of the template itself should be involved in the joining process.Because practicing chemists often work on a series of projects for which particular structural motifs are frequently encountered, but not all of them are common throughout chemistry as a whole, it is also important to ensure that the list of available templates can be extended easily.copy and cut actions that have become a standard part of the desktop metaphor place a single template onto the clipboard, and paste reads the template back out and applies it, using the same algorithm as is used for grafting predefined templates. The clipboard therefore shares the same primitive classes as the template functionality.A standard convenience feature made available by almost all molecular drawing programs is the ability to copy portions of the current molecule onto a temporary container, often referred to as the clipboard, then paste them back later. For the purposes of this work, the clipboard should be considered as a single temporary template, i.e. the This primitive class describes two operations: copying a molecular fragment to a temporary container, such as the system clipboard, and copying a molecular fragment to a persistent collection of fragments, such as a group of templates.The template fragment itself is generated by considering the subject atoms to define a substructure, which is excised from the current structure.If the subject atoms make up whole connected components, i.e. they are not bonded to any atoms which are not part of the subject, then the template fragment is taken to be the substructure in its entirety.guide atoms for the primitive classes which make use of them, which is described below.Otherwise, all atoms which are immediately connected to one or more of the subject atoms are also included in the template fragment, but have their atom type converted into a placeholder atom label. In the examples shown in Figure A logical primitive is defined for each template that is available to the user, including the clipboard, if it contains a suitable molecular structure. The template fragment is an implicit parameter of the primitive. When the operation is instigated, several classes of behaviour will be investigated, depending on the nature of the template fragment and the subject.The objective of the grafting procedure is to produce a list of putative new structures, each of which is a plausible way in which the template might be appended to the existing structure. Each of the following primitive classes is given an opportunity to generate some number of potential new structures, if appropriate.guide atoms. The presence of these atoms introduces opportunities for special behaviour. Using guide atoms is a way to reduce the degrees of freedom when it comes to the possible types of outcomes, which is useful when a template was designed with the intention of using a specific attachment mode. It is also necessary when the attachment modes favour nonstandard bond distances or angles, which would not ordinarily be generated by the geometry perception algorithms.As described previously, templates may have special When there are no subject atoms, adding a template to the current structure is straightforward. It needs to be placed in an area where its atoms and bonds do not interfere with any that already exist, e.g. to the right and centre of the current structure.All possible rotations of increments of 30\u00b0 and 45\u00b0 are included in the list of output structures. If the template contains guide atoms, they are stripped out.If there is one subject atom, this primitive applies. If the template contains guide atoms, they are stripped out.New structures are generated using the following overall sequence:Mirror to be the mirror image equivalent of the Template.1. Define N, in the template fragment.2. Loop over each atom, Template, N}.3. Direct Connect {Mirror, N}.4. Direct Connect {Template, N}.5. Bridge Connect {Mirror, N}.6. Bridge Connect {let x = -x. If there are any bonds with inclined or declined stereochemistry, these are interchanged.The connections are repeated with the mirror image of the template structure, in case it is not symmetrical. Generation of the mirror image is done by inverting one of the axes, e.g. N) of the template fragment, and finding suitable angles by which to rotate the fragment. Bridge connection involves creating a new bond between the two atoms, rather than mapping them onto each other.There are two main methods used for grafting templates using a single atom as the frame of reference. Direct connection involves overlaying the subject atom of the initial structure with the iterated atom . The template fragment is translated so that atom N is superimposed on top of the subject atom from the starting structure. The template fragment is rotated by \u03b81-\u03b82+180\u00b0, about the atom N. The two fragments are then combined, and the result recorded.Both sets of angles are iterated over .3. Loop over each atom, 1 Nso that the direction of the 1N2 Nvector matches that of the first two subject atoms.4. Rotate the template fragment about 5. Match all remaining atoms.In step 4, the position of the first subject atom is used as the axis of rotation, so that the directions of the first two atoms are aligned. In the example shown in Figure 2 Nfrom the template fragment does not now overlap the position of the second subject atom, then the graft is rejected. Once the first two atoms are aligned and matched, the remaining subject atoms are each required to overlap with one of the template atoms. If any of them do not, the graft is rejected.If the position of the atom Once all of the atoms are matched, the fragments are merged, as described in Appendix 2, and a new structure is added to the list.If there is one subject atom, and the template contains one guide atom, and the guide atom has one adjacent neighbour, this primitive applies.bridge connect variant of the Graft with Atom Connection primitive, except with less degrees of freedom, because there is only one applicable template atom, and the projection direction and magnitude is defined by the guide atom.Grafting a template containing a single guide atom to a single subject atom has a similar effect to the The list of projection angles emerging from the subject atom is calculated. These angles are matched against the angle formed from the guide to its neighbour. In the example shown in Figure The bond distance is taken from the distance between the guide atom and its neighbour, rather than using the default bond distance. As with the other grafting primitives, the process is repeated with the mirror image of the template fragment. Once the grafting is complete, the bond connecting the guide atom to the rest of the template fragment is attached to the subject atom, and the guide atom is deleted. The remaining atoms are merged together if there is any overlap.The main benefit of this primitive arises when a template is to be affixed using an irregular or non-obvious geometry, but it is also a way to ensure that a specific template connection point is used preferentially.If there are two subject atoms, and they are bonded to each other, and the template contains one guide atom, and the guide atom has one adjacent neighbour, this primitive applies.The template grafting is done by mapping the subject bond and the template fragment bond to each other. There are 4 base permutations, obtained by using the template fragment vs. its mirror image, and aligning the matched bonds in both parallel and anti-parallel fashion.There is a further bifurcation if the two bonds differ in length: in one case the guide atom is mapped onto the first subject atom, and in the other case the atom adjacent to the guide atom is mapped onto the second subject atom, which is illustrated in Figure Graft with One Guide Atom primitive, because both of the connection angles and the bond distance can be defined prior to the grafting process, which is particularly useful if the subject contains an irregular geometry or nondefault bond distance.This primitive is useful as a constrained case of the If there is at least one subject atom, and the template contains at least one guide atom, this primitive applies in the following cases:1. There is one subject atom and one guide atom, and the guide atom has more than one neighbour.2. There are 2 or more subject atoms, and the number of guide atoms is equal to the number of subject atoms.Graft with One Guide Atom primitive. Bond angle projections are generated from the source atom. For the template fragment, a median angle is generated, by considering the angles between the guide atom and the atoms adjacent to it. In the example shown in Figure The first case is dealt with in a similar way to the Graft with Multiple Connections, except that the guide atoms are used to map the template fragment. As shown in Figure The second case is handled using the same technique as for When any successful matches are found, in which all of the guide atoms can be mapped onto a subject atom, the structures are merged together and the guide atoms are deleted.After each of the primitives described above has had its chance to generate some number of putative new structures, the result list is processed. First, the list is trimmed such that whenever any two structures are found to be equivalent, one of the structures is removed from the list. The method used to decide whether two structures are equivalent is described in Appendix 5.Once the unique set of structures is obtained, they must then be scored. The objective of scoring is to present the most feasible fused structures first, such that the user is most likely to see the desired result presented first and foremost. In cases where it is clear that some structures are significantly more reasonable than others , then some of the results can be omitted.The score for each grafted template result is computed by adding the following terms, where lower is better:1. The total congestion of the molecule (see Appendix 4).2. +1 for each atom that was merged with another atom due to positional overlap.3, sp2 or sp hybridised, and received a new bond which was not positioned at an angle 120\u00b0 (sp3 and sp2) or 180\u00b0 (sp) from its neighbours, with a tolerance of 5\u00b0.3. +50 for each atom of element type C, N, O, P or S which is clearly sp4. +1000 for every carbon or nitrogen atom with a total bond order of 5 or more.5. -1 for every guide atom involved in the grafting process.The scoring system heavily favours regular bond angles, prefers to add new atoms in less congested orientations, and encourages avoidance of certain types of impossible structures.If the best available structure has a score of less than 1000, then all structures with a score of 1000 or more are excluded.Once the scoring is complete, the structures are ordered so that the results with the lowest scores are shown first. For user interface purposes, it is appropriate to allow the user to traverse the list of potential structures, and select the desired result, if there is more than one. The best scoring result is frequently the intended result of the operation.The unit primitives which have been described thus far provide a way to draw or modify structure diagrams with a small number of steps and a much lower input bandwidth than would be required from a conventional software package which relies on a pixel-perfect pointing device, such as a mouse or trackpad. The following examples illustrate the steps required in order to draw three molecules from scratch, using the primitives described in this work.The first example, shown in Figure Graft with No Connections: benzenea. New Bond with Order: 1b. New Bond with Order: 2c. Switch Geometryd. New Bond with Order: 1e. Set Element Label: Of. New Bond with Order: 1g. Set Element Label: Oh. Graft with Atom Connection: acetyli. ingenol [The natural product ingenol  can be dGraft with No Connections: cycloheptanea. Graft with Multiple Connections: cycloheptaneb. Delete Atomsc. Graft with Bond Connection: cyclopentaned. Graft with Bond Connection: cyclopropanee. New Bond with Order: 2f. Flip Atoms: vertical. Note that the two atoms making up the double bond are selected, while the source of the terminal bond is the current atom.g. Set Stereo Style: inclinedh. Set Stereo Style: inclined. Note that this reverses the direction of the already extant wedge.i. Set Bond Order: 2j. New Bond with Order: 1k. New Bond with Stereo Style: inclinedl. New Bond with Stereo Style: declinedm. New Bond with Geometry: tetrahedral (variant #1). Note this primitive is issued twice, in order to create two new bonds.n. New Bond with Order: 1o. Set Element Label: Op. Set Element Label: Hq. The gold-based catalytic intermediate for a carboxylation reaction  is drawnGraft with Atom Connection: cyclopropanea. Set Bond Order: 2b. Set Element Label: Nc. New Bond with Order: 1d. Graft with Atom Connection: benzenee. New Bond with Stereo Style: declinedf. New Bond with Stereo Style: inclinedg. New Bond with Order: 1. Note this primitive is issued twice, in order to create two new bonds for each of the selected atoms.h. Create Template: copy to clipboard.i. Graft with One Guide Atom: paste from clipboard.j. Scale Atoms: growk. New Bond with Geometry: linearl. Set Element Label: Om. New Bond with Geometry: linearn. Graft with Bond Connection: acetylo. Graft with Atom Connection: cyclopentadienep. Set Element Label: Nq. Set Element Label: Or. A collection of unit primitives for sketching molecular diagrams has been described. It is complete, such that complex molecules can be drawn by stringing together a series of these primitives. It is efficient, insofar as the more regular components of a chemical structure can be drawn using a small number of primitives, since only a very small amount of information must be transmitted from the user in order for the algorithms to infer the intent. Less regular features can be created by manipulating atom positions or angles using a variety of low level primitives, but a number of implicit shortcuts can be exploited to keep repetitive actions to a minimum.Several representative examples have been shown, which illustrate the relatively small number of steps and low information content necessary to draw complex molecular geometries, and obtain publication-quality depiction layout coordinates.The primitives described in this work provide the tools needed to build a user interface in which input is limited to selecting atoms and picking from menu choices. The interface can expose the primitives by several means, such as menu bars, icon toolbars, keyboard shortcuts, etc. As long as all of the primitives are conveniently available, the user interface will provide a complete and efficient molecule drawing tool.These primitives have been implemented in a commercial software product called the Mobile Molecular DataSheet (MMDS), which is available for BlackBerry smartphones and iPhone/iPod/iPad devices . Both veWhile the motivation for this work arose from the need to provide molecular sketching capabilities on mobile devices with tiny screens and lack of accurate pointing devices, the set of primitives has applicability outside of this niche.One analogous situation is found in web-based applications where the capabilities of the browser must be assumed to be a lowest common denominator, which requires that the web server do most of the work . Under tde novo series [The primitives described in this work were designed for the purpose of using them to compose a user interface, but they may find applicability as part of scripted processes. For example, when producing a series of chemical structures as part of a combinatorial library ,21 or soo series -24, it mBecause a molecular sketch does not correspond to a physical model, the 2 D coordinates of the atoms are chosen so that they can be presented on a screen or a piece of paper, in such a way that chemists can quickly perceive the structural features and be able to ascertain stereochemistry from the layout and additional annotations.The choice of units for the coordinates is arbitrary, but in this work, Angstroms are used. The default unit of distance between any two atoms is 1.5 \u00c5, which applies regardless of atom and bond type.overlapping. Some of the algorithms described in this work consider overlapping atoms as a cue to merge two atoms together. Otherwise, the presence of overlapping atoms is generally considered to be an error state, since this makes visual perception of a diagram difficult.Any two atoms that are closer than 0.2 \u00c5 are considered to be The template grafting algorithms described in this work mostly operate by joining specific atoms together. While these atoms are merged, bonded or deleted according to the algorithm, there is also the possibility for additional atoms to overlap. This situation is dealt with according to the following steps.The composite structure is partitioned into its two sources, i.e. atoms that originated from the starting structure, and atoms that originated from the grafted fragment. Pairwise combinations of these atoms are examined to see if they overlap. When an overlap is found, one atom must be retained, and the other atom deleted. Before the other atom is deleted, its bonds must be reassigned to the retained atom.exotic each atom is, which is calculated by assigning one point for each condition that applies:The decision as to which atom to retain is made based on how - Having an element label other than carbon- Non-zero charge- Any unpaired electrons- Non-default isotope abundance- Specific non-automatic hydrogen countThe most exotic atom is retained, or the first one, if they are equally so.exoticness of a bond is assigned by one point for each of:During the merging process, it is possible to create duplicate bonds. A similar process is used to decide which bond to keep. The - Bond order other than 1- Any stereochemical assignmentAs for atoms, the first bond is retained in the event of a draw.Other primitives besides template grafting also have need to merge together atoms which happen to overlap. In these cases the same procedure is used, but without the partitioning.For many of the primitives described in this work, it is necessary to produce a list of potential angles for a new bond that will be created with a particular source atom and bond order in mind. When the list of angles produced contains the result which is desired by the user, the amount of effort required to draw the structure is considerably reduced.The following sequence is used to obtain a list of potential new bond angles:1. If the atom is isolated, return four angles, aligned on the X and Y axes.2. Match the atom's bond topology to likely geometry templates , classify as either s-block atoms, classify as either trigonal, square planar or either of the octahedral geometries.b. For trigonal, square planar or either of the tetrahedral geometries.c. If the atom is carbon, and the bonds are all single, classify as either trigonal.d. If the atom is carbon, and the bonds are not all single, classify as p-block, and in the first 3 rows, classify as being trigonal, either of the tetrahedral geometries, or square planar.d. If the atom is in the p-block, but not in the first 3 rows, classify as being any of the available geometries.f. If the atom is in the octahedral geometries.g. Otherwise, classify as either of the two Once the possible classifications have been enumerated, each of them is checked to see if there is any way the current geometry can match it, within a tolerance of 2\u00b0. The first postulated geometry to achieve a match is given precedence. All of the nondegenerate vacant bond directions implied by the ways in which it can match the input structure are returned as the resulting list of possible new bond geometries.If no matches were found, the list of current bond angles are sorted by bond angle. For each bond, the angle directly in between itself and the next angle in the list  is calculated and added to the result list.congestion to make decisions about where to place a new atom, bond or fragment, when an otherwise degenerate choice is available. The position which places new atoms as far away as possible from existing atoms is frequently preferable to the alternatives.A number of the primitives use The congestion at a specific point is calculated by:i iterates over each atom in the structure, and x and y denote the atomic position, where the subscripted variables are the positions of existing atoms.where The total congestion of a molecule is calculated by:i and j iterate over all unique pairs of atoms.where Two structures A and B are considered equivalent or not according to the following algorithm:1. If the number of atoms or bonds is different, the structures are different.2. The structures are translated so that their centre positions are the same. Each atom in structure A is mapped uniquely to the closest atom in structure B, which must be within 0.2 \u00c5.3. If any atoms are not successfully mapped, the structures are different.4. Every atom in structure A must be mapped to an atom in structure B which has the same element label, charge, unpaired electron count, etc. If any mapped pair of atoms are not the same, the structures are different.a1 and a2, there must be a corresponding bond in structure B, between atoms b1 and b2, where a1:b1 and a2:b2 are mapped to each other. If the bond stereochemistry type is not a wedge bond (inclined or declined), the inverse mapping, a1:b2 and a2:b1, is also permitted. If no such pair can be found, the structures are different. The matched bonds must have the same order and stereochemistry type. If not, the structures are different.5. For every bond in structure A, between atoms 6. If no differences were found, the two structures are equivalent.This comparison considers alternate tautomers and Kekul\u00e9 resonance forms to be different species, which is desirable for sketching purposes. The determination of the equivalence of two sketches, as described above, should not be confused with methods used to determine whether two connection tables represent the same molecule, such as unique SMILES  or InChIA list of template fragments grouped into categories is provided [Additional file Additional examples of diagram drawing using the primitives described in this work can be found online .The author is the founder and president of Molecular Materials Informatics, Inc., which produces the Mobile Molecular DataSheet, a working implementation of the primitives described in this manuscript. This publication is a disclosure of the algorithms that form the basis of a commercial product.Suggested default template fragments. A printable document containing diagrams of template fragments.Click here for fileSuggested default template fragments (SD files). A collection of MDL SD files, one per group, containing machine-readable data for each of the template fragments.Click here for file"]}
{"representative": "Cardiovascular diseases (CVD) are the leading cause of death and the third cause of disability in Europe. Prevention programmes should include interventions aimed at a reduction of medical risk factors  as well as behavioural risk factors . The aim of this study is to investigate the effects of a multifaceted, multidisciplinary electronic prevention programme on cardiovascular risk factors.In a randomized controlled trial, one group will receive a maximal intervention (= intervention group). The intervention group will be compared to the control group receiving a minimal intervention. An inclusion of 350 patients in total, with a follow-up of 3 years is foreseen. The inclusion criteria are age between 25\u201365 and insured by the Onderlinge Ziekenkas, insuring for guaranteed income in case of illness for self-employed. The maximal intervention group receives several prevention consultations by their general practitioner (GP) using a new type of cardiovascular risk calculator with personalised feedback on behavioural risk factors. These patients receive a follow-up with intensive support of health behaviour change via different methods, i.e. a tailored website and personal advice of a multidisciplinary team . The aim of this strategy is to reduce cardiovascular risk factors according to the guidelines. The primary outcome measures will be cardiovascular risk factors. The secondary outcome measures are cardiovascular events, quality of life, costs and incremental cost effectiveness ratios. The control group receives prevention consultations using a new type of cardiovascular risk calculator and general feedback.This trial incorporates interventions by GPs and other health professionals aiming at a reduction of medical and behavioural cardiovascular risk factors. An assessment of clinical, psychological and economical outcome measures will be performed.ISRCTN23940498 In Europe, cardiovascular disease (CVD) is the leading cause of death (1.5 million deaths per year) and is an important source of disability . The incPreCardio is a randomized controlled trial. Approval was obtained from the ethics committee of the University Hasselt. A total of 350 subjects will be included in the study with a follow-up of 3 years. The inclusion criteria are age between 25\u201365 and insured by the Onderlinge Ziekenkas, insuring for guaranteed income in case of illness for self-employed. All study participants need to sign an informed consent and have access to the internet. Other eligitability criteria are not included.study participants will be recruited through various channels. Firstly, all potential participants are insured by \"De Onderlinge Ziekenkas\". This membership gives the study secretariat access to necessary contact information. Secondly, all of the insured are self-employed, most of them lawyers. This provides the study office with two advantages: (1) communication is possible at the worksite and (2) the prevention programme is even more tailored to the uniform target group. The announcement of the study was already made through mass-media announcement  but will be intensified at the worksites of the potential participants. Together with the involved Bars (of the province of Limburg in the East of Belgium) mass mailings and promotional activities at the worksite  will be organized. Thirdly, a large event will be organised for the participants of the intervention group and control group. Before joining these events a written informed consent, downloadable on a website with brief information, should be signed and mailed back to the study secretariat. At this large event general information about PreCardio will be given, a first screening and the ability to purchase health-related products.The general practitioners (GP) that will participate in the study are GPs of the province of Limburg, situated in the East of Belgium. They will be recruited with involvement of their own provincial general GP platform \"Limburgs Huisartsenplatform\" and provincial institutions involved in health \"LOGOs\". Together with the GP platform and the LOGOs mass mailings to GPs of Limburg will be organised. Moreover, minimal two information sessions for GPs will be organised in the university building with information about the study and education about a new type of cardiovascular risk calculator will be offered. All participating GPs need to sign an informed consent and have access to the internet for downloading an electronic cardiovascular risk screenings programme based on the European Guidelines for CVprevention. Th. Th15]. For physical activity assessment it is important that each study participant gives an estimate of the intensity, duration and frequency of the physical activity he has in daily life. For this purpose a Dutch translation and computerized version of the International Physical Activity Questionnaire (IPAQ) was chosen. This cor from 0.45 to 0.77), and adequate validity comparing the food-frequency questions with 7-day food records (Spearman r from 0.38 to 0.53)[To stimulate rapid assessment only data collection will be limited to fat intake and fruit and vegetable intake. For fat intake assessment a computerized fat intake questionnaire with a good reliability and adequate validity was chosen. For fru to 0.53).To obtain data about smoking behaviour, a short questionnaire regarding smoking from a national health questionnaire used by the federal government was selected. This quThe Dutch translation of the Short Form 36 (SF-36) will be used to measure Health Related Quality of Life (HRQoL). This version was successfully tested in a Belgian and Dutch population with a Chronbach's alpha coefficient ranging from 0.81 to 0.91,22.Stages of change is a construct from the TransTheoretical Model. The staAttitudes are an important element in the Theory of Planned Behaviour. As recoSelf-identity is seen as the extent to which people see them fulfilling different societal roles. In thisPerceived control over behaviour is related to self-efficacy, the two variables are significantly and highly correlated . HoweverSelf-efficacy is usually measured in terms of individuals' confidence in their ability to perform the behaviour . Self-efPeople are autonomously motivated if they experience a true sense of volition and choice and act because of the personal importance of the behaviour ,31. If pIntention to engage in a behaviour is a direct precursor to engaging in the behaviour itself . BehavioSocial support is an important variable influencing behaviour change. ConsequA step test will be used for assessment of physical fitness. The step test procedure used was modified from earlier procedures. The steThe interventions targeted on medical parameters include a first medical prevention consultation with the GP. In this medical prevention consultation the cardiovascular risk (risk on having a heart attack in the next 10 years) will be calculated using a new computer programme. This computer programme is called \"Electronic Prevention Record\" (EPR). Innovative about the EPR is its connection to \"Electronic Medical Record\" (EMR). The EMR is also a computer programme, a record about the medical history and treatment provided to the patient. In the province of Limburg, the setting for the PreCardio-study, 75% of the GPs use an EMR. In BelgAll data collected at the medical prevention consultation are stored in the EPR that is connected to the EMR Fig . Therapewithout tailored feedback and without reminder from study office). It is also used as a means for study measurements at certain times during the 3-year follow up  is about physical activity, fat intake and smoking and is modified for different measurements in time to avoid drop-out. However, the advice will always be formulated very abstract to avoid 'contamination' of the control group as was the case in another multiple risk factor cardiovascular intervention study[The website available for the control group is limited and contains information about the minimal intervention  walking aiming at a health benefit. The programme most in line with the PreCardio mission, namely CVD prevention, is the \"Reduce my risk\" programme. This programme is a fitness programme aimed at improving physical fitness through more intensive PA. The basis for the fitness programme is a specially developed algorithm linked to the step test used in the study Fig . Three dNext to the personalised website with tailored feedback, study participants of the intervention group are entitled to support from a multidisciplinary team. This multidisciplinary team includes: a cardiologist, a general practitioner, a psychologist, a physiotherapist and a dietician. Different media will be available for this personal contact: personal messages on the website, the forum on the website, e-mail, telephone and group sessions. The first types of media will be more frequently used than the latter, dependent on the stage of behaviour change patients are in. Moreover, the cost-effectiveness of the prevention programme must be guarded. The psychologist (= behaviour coach) can aid people more thoroughly with behaviour change, using the different manuals and behavioural (cognitive) therapy.At GP-level a tool for computer-assisted cardiovascular risk screening (EPR) will be implemented. Minimal two information sessions for GPs will be organised in a university building with information about the study and education about the EPR. GPs will have access to an informational website. This informational website contains information about CVD prevention in general with a summary of the latest guidelines . . Furthermore, it contains information about the PreCardio-study and the role of the GP in the study. On this website information about the EPR will be available . GPs are provided with information on behaviour change, including video registrations of motivational interviewing adaptations for PreCardio. In the section on behaviour change more information will be given about the stages of change and type D-personality as a risk factor for CVD. The website for GPs also contains an overview of the personalised website for patients from the intervention group. GPs have access to a forum where they can post messages to open a debate with their participating colleagues about CVD prevention or the PreCardio-study or messages with a question for the PreCardio-team. In other sections contact information and links to relevant websites can be found.et al found a mean systolic blood pressure of 125 mm/Hg (SD 14 mm/Hg)[\u00ae. A two group t-test with a 0,05 two-sided significance level will have 82% power to detect the difference between a Group 1 mean of 120 mm/Hg and a Group 2 mean of 125 mm/Hg, a difference in means of -5 mm/Hg, assuming that the common standard deviation is 14 mm/Hg, when the sample sizes in the two groups are 200 and 100, respectively . Other outcome measures were also used to determine the necessary sample size. A recent study about the effect of a computer-tailored intervention to reduce fat intake included at post-test a mean fat intake of 85 grams/day (SD 34.5 grams/day) [A power calculation was performed to determine the number of study participants needed to detect a significant effect of the PreCardio prevention programme. A t-test will be used to compare the means of the outcome measures from the intervention and the control group. The sample size calculation is based on the population standard deviation of the primary outcome measure. For PreCardio, this is, for instance, systolic blood pressure. Kelley 14 mm/Hg). The samams/day) . A two gams/day) . In thisams/day) . A two gA linear regression model will be employed to assess the effects of the prevention programme on change in overall cardiovascular risk from baseline to 3 year follow-up.Next to an effect evaluation a cost analysis will be performed. There are different costs that will be measured in the PreCardio-study: (1) One-time costs, this is the total cost for the implementation of the prevention programme ; (2) Costs for medical resource use ; (3) Continuous costs: (acute care) costs for CVD, costs for CVD morbidity and mortality, hospitalization costs (4) Administration costs; (5) Personnel costs ; (6) Travelling and time costs (e.g. study participant's time and GP time); (7) Indirect costs due to productivity loss; (8) Material costs and overhead. This study will be performed from a health service perspective.et al., SF-36 data were converted using a specific algorithm into health state utility values for the determination of incremental QALYs[In cost effectiveness analysis incremental cost-effectiveness ratios (ICER) are used as an economic outcome measure. An ICER can be calculated as incremental cost divided by incremental effectiveness . Incremetal QALYs,48.The PreCardio-study is a randomized controlled trial. However, the shared worksite setting could lead to an intervention contamination. In this regard, the failure to find significant effects from the Heartbeat Wales programme due to contamination of the reference area is relevant. PartialSeveral aspects of the PreCardio-study are noteworthy. Firstly, all interventions are based on recent guidelines and knowledge on CVD prevention. Moreover, this knowledge was taken as a basis to develop a new computer programme for GPs. After limited input, this programme automatically determines CVD risk and generates therapeutic goals according to this risk. Furthermore, tailored advice is provided to the study participant. The involvement of GPs in the PreCardio-study is paramount. Secondly, study participants are provided with a number of aids to support them with behaviour change. These include a personalised website with tailored feedback and personal support from a multidisciplinary team. Consequently, a reduction in medical and behavioural risk factors resulting in a reduction in overall CVD risk is expected.BMI, body mass index; BREQ-II, Behavioural Regulation Exercise Questionnaire II; CVD, cardiovascular diseases; EMR, electronic medical record; EPR, electronic prevention record; GP(s), general practitioner(s); HRQoL, Health Related Quality of Life; ICER, cost-effectiveness ratio; ICT, information and communication technology; IPAQ, International Physical Activity Questionnaire; MI, motivational interviewing; PA, physical activity; QALY, Quality Adjusted Life Year; SDT, Self-Determination Theory; SF-36, Short Form 36 TBP, Theory of Planned Behaviour.The author(s) declare that they have no competing interests.The PreCardio-study Protocol was written by prof dr Neree Claes (NC) and psychologist Nele Jacobs (NJ). Both authors have made substantial contributions to this protocol and performed a feasibility study prior to the development of this study protocol. NC, project manager, has elaborated the study design and co-authorised the manuscript. NJ drafted the manuscript and participated in the study design. Both authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:", "texts": ["Cardiovascular diseases (CVD) are the leading cause of death and the third cause of disability in Europe. Prevention programmes should include interventions aimed at a reduction of medical risk factors  as well as behavioural risk factors . The aim of this study is to investigate the effects of a multifaceted, multidisciplinary electronic prevention programme on cardiovascular risk factors.In a randomized controlled trial, one group will receive a maximal intervention (= intervention group). The intervention group will be compared to the control group receiving a minimal intervention. An inclusion of 350 patients in total, with a follow-up of 3 years is foreseen. The inclusion criteria are age between 25\u201365 and insured by the Onderlinge Ziekenkas, insuring for guaranteed income in case of illness for self-employed. The maximal intervention group receives several prevention consultations by their general practitioner (GP) using a new type of cardiovascular risk calculator with personalised feedback on behavioural risk factors. These patients receive a follow-up with intensive support of health behaviour change via different methods, i.e. a tailored website and personal advice of a multidisciplinary team . The aim of this strategy is to reduce cardiovascular risk factors according to the guidelines. The primary outcome measures will be cardiovascular risk factors. The secondary outcome measures are cardiovascular events, quality of life, costs and incremental cost effectiveness ratios. The control group receives prevention consultations using a new type of cardiovascular risk calculator and general feedback.This trial incorporates interventions by GPs and other health professionals aiming at a reduction of medical and behavioural cardiovascular risk factors. An assessment of clinical, psychological and economical outcome measures will be performed.ISRCTN23940498 In Europe, cardiovascular disease (CVD) is the leading cause of death (1.5 million deaths per year) and is an important source of disability . The incPreCardio is a randomized controlled trial. Approval was obtained from the ethics committee of the University Hasselt. A total of 350 subjects will be included in the study with a follow-up of 3 years. The inclusion criteria are age between 25\u201365 and insured by the Onderlinge Ziekenkas, insuring for guaranteed income in case of illness for self-employed. All study participants need to sign an informed consent and have access to the internet. Other eligitability criteria are not included.study participants will be recruited through various channels. Firstly, all potential participants are insured by \"De Onderlinge Ziekenkas\". This membership gives the study secretariat access to necessary contact information. Secondly, all of the insured are self-employed, most of them lawyers. This provides the study office with two advantages: (1) communication is possible at the worksite and (2) the prevention programme is even more tailored to the uniform target group. The announcement of the study was already made through mass-media announcement  but will be intensified at the worksites of the potential participants. Together with the involved Bars (of the province of Limburg in the East of Belgium) mass mailings and promotional activities at the worksite  will be organized. Thirdly, a large event will be organised for the participants of the intervention group and control group. Before joining these events a written informed consent, downloadable on a website with brief information, should be signed and mailed back to the study secretariat. At this large event general information about PreCardio will be given, a first screening and the ability to purchase health-related products.The general practitioners (GP) that will participate in the study are GPs of the province of Limburg, situated in the East of Belgium. They will be recruited with involvement of their own provincial general GP platform \"Limburgs Huisartsenplatform\" and provincial institutions involved in health \"LOGOs\". Together with the GP platform and the LOGOs mass mailings to GPs of Limburg will be organised. Moreover, minimal two information sessions for GPs will be organised in the university building with information about the study and education about a new type of cardiovascular risk calculator will be offered. All participating GPs need to sign an informed consent and have access to the internet for downloading an electronic cardiovascular risk screenings programme based on the European Guidelines for CVprevention. Th. Th15]. For physical activity assessment it is important that each study participant gives an estimate of the intensity, duration and frequency of the physical activity he has in daily life. For this purpose a Dutch translation and computerized version of the International Physical Activity Questionnaire (IPAQ) was chosen. This cor from 0.45 to 0.77), and adequate validity comparing the food-frequency questions with 7-day food records (Spearman r from 0.38 to 0.53)[To stimulate rapid assessment only data collection will be limited to fat intake and fruit and vegetable intake. For fat intake assessment a computerized fat intake questionnaire with a good reliability and adequate validity was chosen. For fru to 0.53).To obtain data about smoking behaviour, a short questionnaire regarding smoking from a national health questionnaire used by the federal government was selected. This quThe Dutch translation of the Short Form 36 (SF-36) will be used to measure Health Related Quality of Life (HRQoL). This version was successfully tested in a Belgian and Dutch population with a Chronbach's alpha coefficient ranging from 0.81 to 0.91,22.Stages of change is a construct from the TransTheoretical Model. The staAttitudes are an important element in the Theory of Planned Behaviour. As recoSelf-identity is seen as the extent to which people see them fulfilling different societal roles. In thisPerceived control over behaviour is related to self-efficacy, the two variables are significantly and highly correlated . HoweverSelf-efficacy is usually measured in terms of individuals' confidence in their ability to perform the behaviour . Self-efPeople are autonomously motivated if they experience a true sense of volition and choice and act because of the personal importance of the behaviour ,31. If pIntention to engage in a behaviour is a direct precursor to engaging in the behaviour itself . BehavioSocial support is an important variable influencing behaviour change. ConsequA step test will be used for assessment of physical fitness. The step test procedure used was modified from earlier procedures. The steThe interventions targeted on medical parameters include a first medical prevention consultation with the GP. In this medical prevention consultation the cardiovascular risk (risk on having a heart attack in the next 10 years) will be calculated using a new computer programme. This computer programme is called \"Electronic Prevention Record\" (EPR). Innovative about the EPR is its connection to \"Electronic Medical Record\" (EMR). The EMR is also a computer programme, a record about the medical history and treatment provided to the patient. In the province of Limburg, the setting for the PreCardio-study, 75% of the GPs use an EMR. In BelgAll data collected at the medical prevention consultation are stored in the EPR that is connected to the EMR Fig . Therapewithout tailored feedback and without reminder from study office). It is also used as a means for study measurements at certain times during the 3-year follow up  is about physical activity, fat intake and smoking and is modified for different measurements in time to avoid drop-out. However, the advice will always be formulated very abstract to avoid 'contamination' of the control group as was the case in another multiple risk factor cardiovascular intervention study[The website available for the control group is limited and contains information about the minimal intervention  walking aiming at a health benefit. The programme most in line with the PreCardio mission, namely CVD prevention, is the \"Reduce my risk\" programme. This programme is a fitness programme aimed at improving physical fitness through more intensive PA. The basis for the fitness programme is a specially developed algorithm linked to the step test used in the study Fig . Three dNext to the personalised website with tailored feedback, study participants of the intervention group are entitled to support from a multidisciplinary team. This multidisciplinary team includes: a cardiologist, a general practitioner, a psychologist, a physiotherapist and a dietician. Different media will be available for this personal contact: personal messages on the website, the forum on the website, e-mail, telephone and group sessions. The first types of media will be more frequently used than the latter, dependent on the stage of behaviour change patients are in. Moreover, the cost-effectiveness of the prevention programme must be guarded. The psychologist (= behaviour coach) can aid people more thoroughly with behaviour change, using the different manuals and behavioural (cognitive) therapy.At GP-level a tool for computer-assisted cardiovascular risk screening (EPR) will be implemented. Minimal two information sessions for GPs will be organised in a university building with information about the study and education about the EPR. GPs will have access to an informational website. This informational website contains information about CVD prevention in general with a summary of the latest guidelines . . Furthermore, it contains information about the PreCardio-study and the role of the GP in the study. On this website information about the EPR will be available . GPs are provided with information on behaviour change, including video registrations of motivational interviewing adaptations for PreCardio. In the section on behaviour change more information will be given about the stages of change and type D-personality as a risk factor for CVD. The website for GPs also contains an overview of the personalised website for patients from the intervention group. GPs have access to a forum where they can post messages to open a debate with their participating colleagues about CVD prevention or the PreCardio-study or messages with a question for the PreCardio-team. In other sections contact information and links to relevant websites can be found.et al found a mean systolic blood pressure of 125 mm/Hg (SD 14 mm/Hg)[\u00ae. A two group t-test with a 0,05 two-sided significance level will have 82% power to detect the difference between a Group 1 mean of 120 mm/Hg and a Group 2 mean of 125 mm/Hg, a difference in means of -5 mm/Hg, assuming that the common standard deviation is 14 mm/Hg, when the sample sizes in the two groups are 200 and 100, respectively . Other outcome measures were also used to determine the necessary sample size. A recent study about the effect of a computer-tailored intervention to reduce fat intake included at post-test a mean fat intake of 85 grams/day (SD 34.5 grams/day) [A power calculation was performed to determine the number of study participants needed to detect a significant effect of the PreCardio prevention programme. A t-test will be used to compare the means of the outcome measures from the intervention and the control group. The sample size calculation is based on the population standard deviation of the primary outcome measure. For PreCardio, this is, for instance, systolic blood pressure. Kelley 14 mm/Hg). The samams/day) . A two gams/day) . In thisams/day) . A two gA linear regression model will be employed to assess the effects of the prevention programme on change in overall cardiovascular risk from baseline to 3 year follow-up.Next to an effect evaluation a cost analysis will be performed. There are different costs that will be measured in the PreCardio-study: (1) One-time costs, this is the total cost for the implementation of the prevention programme ; (2) Costs for medical resource use ; (3) Continuous costs: (acute care) costs for CVD, costs for CVD morbidity and mortality, hospitalization costs (4) Administration costs; (5) Personnel costs ; (6) Travelling and time costs (e.g. study participant's time and GP time); (7) Indirect costs due to productivity loss; (8) Material costs and overhead. This study will be performed from a health service perspective.et al., SF-36 data were converted using a specific algorithm into health state utility values for the determination of incremental QALYs[In cost effectiveness analysis incremental cost-effectiveness ratios (ICER) are used as an economic outcome measure. An ICER can be calculated as incremental cost divided by incremental effectiveness . Incremetal QALYs,48.The PreCardio-study is a randomized controlled trial. However, the shared worksite setting could lead to an intervention contamination. In this regard, the failure to find significant effects from the Heartbeat Wales programme due to contamination of the reference area is relevant. PartialSeveral aspects of the PreCardio-study are noteworthy. Firstly, all interventions are based on recent guidelines and knowledge on CVD prevention. Moreover, this knowledge was taken as a basis to develop a new computer programme for GPs. After limited input, this programme automatically determines CVD risk and generates therapeutic goals according to this risk. Furthermore, tailored advice is provided to the study participant. The involvement of GPs in the PreCardio-study is paramount. Secondly, study participants are provided with a number of aids to support them with behaviour change. These include a personalised website with tailored feedback and personal support from a multidisciplinary team. Consequently, a reduction in medical and behavioural risk factors resulting in a reduction in overall CVD risk is expected.BMI, body mass index; BREQ-II, Behavioural Regulation Exercise Questionnaire II; CVD, cardiovascular diseases; EMR, electronic medical record; EPR, electronic prevention record; GP(s), general practitioner(s); HRQoL, Health Related Quality of Life; ICER, cost-effectiveness ratio; ICT, information and communication technology; IPAQ, International Physical Activity Questionnaire; MI, motivational interviewing; PA, physical activity; QALY, Quality Adjusted Life Year; SDT, Self-Determination Theory; SF-36, Short Form 36 TBP, Theory of Planned Behaviour.The author(s) declare that they have no competing interests.The PreCardio-study Protocol was written by prof dr Neree Claes (NC) and psychologist Nele Jacobs (NJ). Both authors have made substantial contributions to this protocol and performed a feasibility study prior to the development of this study protocol. NC, project manager, has elaborated the study design and co-authorised the manuscript. NJ drafted the manuscript and participated in the study design. Both authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:"]}
{"representative": "Sex Hormones and Physical Exercise (SHAPE) study. Purpose of SHAPE study is to examine the effects of a 1-year moderate-to-vigorous intensity exercise programme on endogenous hormone levels associated with breast cancer among sedentary postmenopausal women and whether the amount of total body fat or abdominal fat mediates the effects.Physical activity has been associated with a decreased risk for breast cancer. The biological mechanismn(s) underlying the association between physical activity and breast cancer is not clear. Most prominent hypothesis is that physical activity may protect against breast cancer through reduced lifetime exposure to endogenous hormones either direct, or indirect by preventing overweight and abdominal adiposity. In order to get more insight in the causal pathway between physical activity and breast cancer risk, we designed the In the SHAPE study, 189 sedentary postmenopausal women, aged 50\u201369 years, are randomly allocated to an intervention or a control group. The intervention consists of an 1-year moderate-to-vigorous intensity aerobic and strenght training exercise programme. Partcipants allocated to the control group are requested to retain their habitual exercise pattern. Primary study parameters measured at baseline, at four months and at 12 months are: serum concentrations of endogenous estrogens, endogenous androgens, sex hormone binding globuline and insuline. Other study parameters include: amount of total and abdominal fat, weight, BMI, body fat distribution, physical fitness, blood pressure and lifestyle factors.This study will contribute to the body of evidence relating physical activity and breast cancer risk and will provide insight into possible mechanisms through which physical activity might be associated with reduced risk of breast cancer in postmenopausal women.NCT00359060 Most of the established risk factors for breast cancer, such as family history of the disease, early age at menarche, late age at menopause, late age at first childbirth or nulliparity are not, or not easily, amenable to intervention. Physical activity is a modifiable lifestyle characteristic that has been associated with breast cancer risk in various studies -22 and aFurthermore, both an early menarche and a late menopause increase risk, probably by increasing lifetime exposure to ovarian hormones ,34. SeveSo far, one study has reported on the effects of an exercise intervention on sex steroid concentration among postmenopausal women. This study observed that a 12-month moderate-intensity exercise intervention in sedentary, overweight women resulted in small but significant decreases in serum estrogens and androgens. These results were restricted to women who lost a certain amount of body fat.Sex Hormones and Physical Exercise (SHAPE) study. This study examines the effect of an exercise intervention on sex steroid hormones and insulin in sedentary postmenopausal women and investigates if the amount of total body fat or abdominal fat mediates the effect. If increase in physical activity has a beneficial effect on the sex hormone and metabolic profile of postmenopausal women, it will offer opportunities for breast cancer prevention programs. This paper presents the design and evaluation plan of the SHAPE study.In order to get more insight in the causal pathway between physical activity and breast cancer risk, we designed the The SHAPE study examines the effects of a 1-year moderate intensity exercise programme on endogenous hormone levels  associated with breast cancer among sedentary postmenopausal women. The study is designed as a single blind, randomised, controlled trial with two study arms.We chose to include only postmenopausal women because (a) there is more evidence for an inverse association between physical activity and breast cancer risk in postmenopausal women (b) the incidence of breast cancer is greatest in postmenopausal years (c) the major conversion locus of androgens into estrogens in postmenopausal women is fat tissue \u2013 a reduction in fat mass through exercise may be more likely to affect the relative concentrations of estrogens on postmenopausal women than in premenopausal women (d) there are no problems associated with measurements of hormones with timing of the menstrual cycle.The SHAPE study includes 189 healthy postmenopausal women aged 50 tot 69 year, who are sedentary and not currently using postmenopausal hormone replacement therapy. Postmenopausal status is defined as not having menstrual periods for at least 12 months. Being sedentary is defined as less than 2 hours per week of moderate sport activity  and not adherent to the international physical activity recommendation. The international physical activity recommendation states that every adult should accumulate 30 minutes or more of at least moderately intense physical activity for at least five days per week ,47. The Participants are recruited through a random selection out of the female inhabitants aging 50\u201369 years of the following middle sized municipalities in the centre of The Netherlands: Utrecht, Zeist, Bilthoven, Houten, Soest en IJsselstein. Potential candidates receive an invitation letter explaining the goal of the study and a short eligibility questionnaire. Next, the potential candidates are contacted by phone to explain further details and the inclusion criteria list is completed to screen eligibility. Additionally, interested and eligible women receive written study information and are asked to complete and sign an informed consent form. With the women who return their informed consent form an appointment for the baseline visit at our research unit is made. See Figure Eligible women are randomised into an intervention group or a control group. Randomisation is blocked on two categories of waist circumference: < 92 cm and \u2265 92 cm .Women in the intervention group participate in a combined endurance and strength training programme over a period of 12 months. The programme is organised in a way to optimise fat loss. The goal of the intervention programme is to have participants exercise at least 3 times per week  and to reach a training stimulus in each person. In general, implementation of the exercise goals is done slowly, to reduce chance of injury and to increase participants' adherence and sense of accomplishments.Twice a week the participants of the intervention group meet for an exercise session of one hour. Each group includes about 15\u201320 women. A qualified sports instructor facilitates the standardised group sessions according to a protocol. Group exercise takes place in six fitness centres located in the subjects' home town. Classes start with a 10-minute warming up: e.g. exercise to music routines and walking. Then the training is continued with moderate-to-vigorous level of aerobic exercise on 60 \u2013 85% of the age-predicted maximum heart rate. The maximum heart rate is established as 220 minus the person's age in years. The participants receive heart rate monitors to control their training intensity. The training session ends with 25 minutes strength exercises and 5 minutes cooling down. The sport instructor registers the attendance of the subjects. Since it is important that the group exercise sessions are conducted uniformly in all centres, all instructors who participate in the SHAPE study are instructed extensively. In addition, the study coordinator (EM) performs several monitor visits per exercise group to control adherence to the protocol.Previous experience showed that group exercises are preferred by Dutch women of this age and are better adhered to in the short and long term . HoweverOnce a week the participants are asked to perform an individual home-based exercise session. They receive instructions during the group sessions. The home-based exercise programme consists of 30 minutes brisk walking or cycling with an intensity of moderate-to-vigorous intensity . Afterwards, the women record the type and duration of their activity in an exercise log, together with the mean heart rate during the training and the BORG-score (6\u201320) for exertion .Participants in the control group are requested to retain their habitual exercise pattern. They also receive newsletters. Although some control subjects may decide to increase their level of physical activity, we believe that it is unlikely that they will sustain in a similar level as the intervention group. Level of physical activity is measured frequently to monitor changes in physical activity (PASE questionnaire) during the course of the intervention.The study participants visit the research unit of the Julius Center at baseline, after 4 months and at the end of the study (See table Blood samples (30 ml per visit) are drawn between 9.00 and 11.00 AM after an overnight fast in order to determine serum concentrations of estradiol , estrone, estrone sulfate testosterone, androstenedione, insuline, glucose and sex hormone binding globulin. Blood samples are stored at -70\u00b0C. All samples from an individual subject are analysed in the same batch since the batch-to-batch variation can be higher than any woman's likely change in hormones over the year . Serum eThe laboratory \"Stichting Huisartsenlaboratorium Oost\" in Velp  performsBody weight and height (to the nearest 0.5 kg and 0.5 cm respectively) are measured while the subjects wear light clothes and no shoes using an analogue balance (SECA) and wall-mounted tape measure.Body fat distribution is measured by the waist- and hip circumference. Waist circumference (to the nearest 0.1 cm) was measured standing at the midway between lower ribs and iliac crest. Hip circumference (to the nearest 0.1 cm) was measured standing over the buttocks. All measurements were taken in duplicate and averaged. Total body fat and body fat percentage are determined by using a whole-body DEXA scan . A whole body scan analyses body composition according to a three-compartment model: fat mass, lean tissue, and bone mineral content. The standard soft tissue analysis is performed using software supplied by the manufacturer. Total body fat is estimated for each subject in kilograms.Intra-abdominal fat is measured by abdominal ultrasound assessment . The ultrasound measure comprises the distance between the peritoneum and the lumbar spine at three predefined places. All measurements are performed longitudinally from one line over the abdomen halfway between the lower rib and iliac crest.Blood pressure is measured with an automatically tonometer (OMRON M4) after participants have been sitting quietly for at least five minutes.2 max). VO2 max is determined by a submaximal cycle test: the Fit Test programme on a Life Fitness cycle ergometer. The theory of the test is based on the \u00c4strand Rhyming Protocol [2 max estimate based on the subject's weight, age, gender, selected resistance, and steady-state heart rate. After the test, the subject pedals without resistance for 2 minutes to cool down.Fitness is measured by the maximal oxygen uptake  was 0.993 (P < 0.001). Other reliability indexes  were respectively 0.993, 0.532 ml/kg/min and 1.475 ml/kg/min. This reproducibility study showed that the Fit Test is a reproducible measure of submaximal work capacity.To assess reproducibility of the Fit Test, we tested 25 volunteers twice with an average period of 2.0 \u00b1 1.5 days between the tests. Group means and standard deviations of the first and second VOA self-constructed questionnaire  is used to assess level of physical activity, diet, socio-demographic variables, smoking history, medical history and reproductive factors.The general physical activity questionnaire includes the Voorrips questionnaire measuring habitual activity in elderly subjects  and quesThe PASE  questionnaire  measuresDaily caloric intake, percent daily calories from fat, percent daily calories from carbohydrates and proteins is determined by a food frequency questionnaire ,58. The Medication use is asked each visit and registered by use of an internet database. This database is based on the current available medications and uses ATC codes.All randomised subjects will be analysed according to the intent-to-treat principle. The intention-to-treat principle will assess the intervention effect based on assigned treatment at the time of randomisation regardless of adherence. Demographics and baseline characteristics will be reported descriptively. We will assess whether life style factors that are potentially related to hormone levels might have changed differentially between exercisers and controls, including alcohol use and caloric intake. Differences between the treatment groups in primary and secondary efficacy parameters will be analysed by repeated measurement analyses in SAS and 95% confidence intervals will be calculated. We will also assess effect modification by change in intra-abdominal  and, among exercisers only, by adherence levels.In this paper, we present the rationale and design of the SHAPE trial which aims to get more insight in the biological mechanism underlying the observed effect between physical activity and breast cancer risk.The success of the study will depend to a large extent on adherence to the exercise protocol. Factors that enhance adherence to exercise programmes in The Netherlands are group exercise , a varied programme and a regular instructor . We incoIt is also of utmost importance that the control group is compliant with the study protocol, e.g., retaining their habitual lifestyle pattern. Women who are randomised to the control group might be disappointed about the assignment and may take up exercise or change their diet. We monitor the level of physical activity of all participants with questionnaires in order to get insight in the actual amount of physical activity and potential cross-over between both treatment arms. Changes in diet are monitored by a food frequency questionnaire.Six fitness centres and fourteen instructors participate in the SHAPE study. Although the exercise protocol is standardised as much as possible, the attitude and experience of the instructor might influence the actual performance of the participants. In the analysis, we will explore whether outcomes of participants within the same sporting centre are correlated (intracluster correlation). If there is evidence for intracluster correlation, we will account for this in the analysis.Because of the stringent in and exclusion criteria, the participants of the SHAPE study comprise a selected group of postmenopausal women. This type of preselection will not affect the validity of the study (no selection bias) because randomisation is aimed to ensure comparability of intervention and control group but it may limit the generalisability. For example, since we exclude lean women and women not using hormone replacement therapy, the results might not be generalised to these groups of women.So far, one study (PATH study) has been published on the effects of exercise interventions on sex steroid concentration in women . The PATIn summary, this paper shows the rationale and design of the SHAPE study. The SHAPE study aims to unravel the mechanisms underlying the association physical activity and breast cancer risk. Furthermore, this study evaluates the feasibility of delivering an exercise programme for postmenopausal women.2max, Maximum Oxygen Uptake; ATC, Anatomical Therapeutic Chemical Classification SystemBMI, Body Mass Index; DEXA, Dual-Energy X-ray Absorptiometry; SHBG, Sex Hormone Binding Globulin; VOThe author(s) declare that they have no competing interests.EMM, PHMP and AJS designed the study, participated in the coordination of the study and writing of the article. All authors provided comments on the draft and have read the paper.The pre-publication history for this paper can be accessed here:", "texts": ["Sex Hormones and Physical Exercise (SHAPE) study. Purpose of SHAPE study is to examine the effects of a 1-year moderate-to-vigorous intensity exercise programme on endogenous hormone levels associated with breast cancer among sedentary postmenopausal women and whether the amount of total body fat or abdominal fat mediates the effects.Physical activity has been associated with a decreased risk for breast cancer. The biological mechanismn(s) underlying the association between physical activity and breast cancer is not clear. Most prominent hypothesis is that physical activity may protect against breast cancer through reduced lifetime exposure to endogenous hormones either direct, or indirect by preventing overweight and abdominal adiposity. In order to get more insight in the causal pathway between physical activity and breast cancer risk, we designed the In the SHAPE study, 189 sedentary postmenopausal women, aged 50\u201369 years, are randomly allocated to an intervention or a control group. The intervention consists of an 1-year moderate-to-vigorous intensity aerobic and strenght training exercise programme. Partcipants allocated to the control group are requested to retain their habitual exercise pattern. Primary study parameters measured at baseline, at four months and at 12 months are: serum concentrations of endogenous estrogens, endogenous androgens, sex hormone binding globuline and insuline. Other study parameters include: amount of total and abdominal fat, weight, BMI, body fat distribution, physical fitness, blood pressure and lifestyle factors.This study will contribute to the body of evidence relating physical activity and breast cancer risk and will provide insight into possible mechanisms through which physical activity might be associated with reduced risk of breast cancer in postmenopausal women.NCT00359060 Most of the established risk factors for breast cancer, such as family history of the disease, early age at menarche, late age at menopause, late age at first childbirth or nulliparity are not, or not easily, amenable to intervention. Physical activity is a modifiable lifestyle characteristic that has been associated with breast cancer risk in various studies -22 and aFurthermore, both an early menarche and a late menopause increase risk, probably by increasing lifetime exposure to ovarian hormones ,34. SeveSo far, one study has reported on the effects of an exercise intervention on sex steroid concentration among postmenopausal women. This study observed that a 12-month moderate-intensity exercise intervention in sedentary, overweight women resulted in small but significant decreases in serum estrogens and androgens. These results were restricted to women who lost a certain amount of body fat.Sex Hormones and Physical Exercise (SHAPE) study. This study examines the effect of an exercise intervention on sex steroid hormones and insulin in sedentary postmenopausal women and investigates if the amount of total body fat or abdominal fat mediates the effect. If increase in physical activity has a beneficial effect on the sex hormone and metabolic profile of postmenopausal women, it will offer opportunities for breast cancer prevention programs. This paper presents the design and evaluation plan of the SHAPE study.In order to get more insight in the causal pathway between physical activity and breast cancer risk, we designed the The SHAPE study examines the effects of a 1-year moderate intensity exercise programme on endogenous hormone levels  associated with breast cancer among sedentary postmenopausal women. The study is designed as a single blind, randomised, controlled trial with two study arms.We chose to include only postmenopausal women because (a) there is more evidence for an inverse association between physical activity and breast cancer risk in postmenopausal women (b) the incidence of breast cancer is greatest in postmenopausal years (c) the major conversion locus of androgens into estrogens in postmenopausal women is fat tissue \u2013 a reduction in fat mass through exercise may be more likely to affect the relative concentrations of estrogens on postmenopausal women than in premenopausal women (d) there are no problems associated with measurements of hormones with timing of the menstrual cycle.The SHAPE study includes 189 healthy postmenopausal women aged 50 tot 69 year, who are sedentary and not currently using postmenopausal hormone replacement therapy. Postmenopausal status is defined as not having menstrual periods for at least 12 months. Being sedentary is defined as less than 2 hours per week of moderate sport activity  and not adherent to the international physical activity recommendation. The international physical activity recommendation states that every adult should accumulate 30 minutes or more of at least moderately intense physical activity for at least five days per week ,47. The Participants are recruited through a random selection out of the female inhabitants aging 50\u201369 years of the following middle sized municipalities in the centre of The Netherlands: Utrecht, Zeist, Bilthoven, Houten, Soest en IJsselstein. Potential candidates receive an invitation letter explaining the goal of the study and a short eligibility questionnaire. Next, the potential candidates are contacted by phone to explain further details and the inclusion criteria list is completed to screen eligibility. Additionally, interested and eligible women receive written study information and are asked to complete and sign an informed consent form. With the women who return their informed consent form an appointment for the baseline visit at our research unit is made. See Figure Eligible women are randomised into an intervention group or a control group. Randomisation is blocked on two categories of waist circumference: < 92 cm and \u2265 92 cm .Women in the intervention group participate in a combined endurance and strength training programme over a period of 12 months. The programme is organised in a way to optimise fat loss. The goal of the intervention programme is to have participants exercise at least 3 times per week  and to reach a training stimulus in each person. In general, implementation of the exercise goals is done slowly, to reduce chance of injury and to increase participants' adherence and sense of accomplishments.Twice a week the participants of the intervention group meet for an exercise session of one hour. Each group includes about 15\u201320 women. A qualified sports instructor facilitates the standardised group sessions according to a protocol. Group exercise takes place in six fitness centres located in the subjects' home town. Classes start with a 10-minute warming up: e.g. exercise to music routines and walking. Then the training is continued with moderate-to-vigorous level of aerobic exercise on 60 \u2013 85% of the age-predicted maximum heart rate. The maximum heart rate is established as 220 minus the person's age in years. The participants receive heart rate monitors to control their training intensity. The training session ends with 25 minutes strength exercises and 5 minutes cooling down. The sport instructor registers the attendance of the subjects. Since it is important that the group exercise sessions are conducted uniformly in all centres, all instructors who participate in the SHAPE study are instructed extensively. In addition, the study coordinator (EM) performs several monitor visits per exercise group to control adherence to the protocol.Previous experience showed that group exercises are preferred by Dutch women of this age and are better adhered to in the short and long term . HoweverOnce a week the participants are asked to perform an individual home-based exercise session. They receive instructions during the group sessions. The home-based exercise programme consists of 30 minutes brisk walking or cycling with an intensity of moderate-to-vigorous intensity . Afterwards, the women record the type and duration of their activity in an exercise log, together with the mean heart rate during the training and the BORG-score (6\u201320) for exertion .Participants in the control group are requested to retain their habitual exercise pattern. They also receive newsletters. Although some control subjects may decide to increase their level of physical activity, we believe that it is unlikely that they will sustain in a similar level as the intervention group. Level of physical activity is measured frequently to monitor changes in physical activity (PASE questionnaire) during the course of the intervention.The study participants visit the research unit of the Julius Center at baseline, after 4 months and at the end of the study (See table Blood samples (30 ml per visit) are drawn between 9.00 and 11.00 AM after an overnight fast in order to determine serum concentrations of estradiol , estrone, estrone sulfate testosterone, androstenedione, insuline, glucose and sex hormone binding globulin. Blood samples are stored at -70\u00b0C. All samples from an individual subject are analysed in the same batch since the batch-to-batch variation can be higher than any woman's likely change in hormones over the year . Serum eThe laboratory \"Stichting Huisartsenlaboratorium Oost\" in Velp  performsBody weight and height (to the nearest 0.5 kg and 0.5 cm respectively) are measured while the subjects wear light clothes and no shoes using an analogue balance (SECA) and wall-mounted tape measure.Body fat distribution is measured by the waist- and hip circumference. Waist circumference (to the nearest 0.1 cm) was measured standing at the midway between lower ribs and iliac crest. Hip circumference (to the nearest 0.1 cm) was measured standing over the buttocks. All measurements were taken in duplicate and averaged. Total body fat and body fat percentage are determined by using a whole-body DEXA scan . A whole body scan analyses body composition according to a three-compartment model: fat mass, lean tissue, and bone mineral content. The standard soft tissue analysis is performed using software supplied by the manufacturer. Total body fat is estimated for each subject in kilograms.Intra-abdominal fat is measured by abdominal ultrasound assessment . The ultrasound measure comprises the distance between the peritoneum and the lumbar spine at three predefined places. All measurements are performed longitudinally from one line over the abdomen halfway between the lower rib and iliac crest.Blood pressure is measured with an automatically tonometer (OMRON M4) after participants have been sitting quietly for at least five minutes.2 max). VO2 max is determined by a submaximal cycle test: the Fit Test programme on a Life Fitness cycle ergometer. The theory of the test is based on the \u00c4strand Rhyming Protocol [2 max estimate based on the subject's weight, age, gender, selected resistance, and steady-state heart rate. After the test, the subject pedals without resistance for 2 minutes to cool down.Fitness is measured by the maximal oxygen uptake  was 0.993 (P < 0.001). Other reliability indexes  were respectively 0.993, 0.532 ml/kg/min and 1.475 ml/kg/min. This reproducibility study showed that the Fit Test is a reproducible measure of submaximal work capacity.To assess reproducibility of the Fit Test, we tested 25 volunteers twice with an average period of 2.0 \u00b1 1.5 days between the tests. Group means and standard deviations of the first and second VOA self-constructed questionnaire  is used to assess level of physical activity, diet, socio-demographic variables, smoking history, medical history and reproductive factors.The general physical activity questionnaire includes the Voorrips questionnaire measuring habitual activity in elderly subjects  and quesThe PASE  questionnaire  measuresDaily caloric intake, percent daily calories from fat, percent daily calories from carbohydrates and proteins is determined by a food frequency questionnaire ,58. The Medication use is asked each visit and registered by use of an internet database. This database is based on the current available medications and uses ATC codes.All randomised subjects will be analysed according to the intent-to-treat principle. The intention-to-treat principle will assess the intervention effect based on assigned treatment at the time of randomisation regardless of adherence. Demographics and baseline characteristics will be reported descriptively. We will assess whether life style factors that are potentially related to hormone levels might have changed differentially between exercisers and controls, including alcohol use and caloric intake. Differences between the treatment groups in primary and secondary efficacy parameters will be analysed by repeated measurement analyses in SAS and 95% confidence intervals will be calculated. We will also assess effect modification by change in intra-abdominal  and, among exercisers only, by adherence levels.In this paper, we present the rationale and design of the SHAPE trial which aims to get more insight in the biological mechanism underlying the observed effect between physical activity and breast cancer risk.The success of the study will depend to a large extent on adherence to the exercise protocol. Factors that enhance adherence to exercise programmes in The Netherlands are group exercise , a varied programme and a regular instructor . We incoIt is also of utmost importance that the control group is compliant with the study protocol, e.g., retaining their habitual lifestyle pattern. Women who are randomised to the control group might be disappointed about the assignment and may take up exercise or change their diet. We monitor the level of physical activity of all participants with questionnaires in order to get insight in the actual amount of physical activity and potential cross-over between both treatment arms. Changes in diet are monitored by a food frequency questionnaire.Six fitness centres and fourteen instructors participate in the SHAPE study. Although the exercise protocol is standardised as much as possible, the attitude and experience of the instructor might influence the actual performance of the participants. In the analysis, we will explore whether outcomes of participants within the same sporting centre are correlated (intracluster correlation). If there is evidence for intracluster correlation, we will account for this in the analysis.Because of the stringent in and exclusion criteria, the participants of the SHAPE study comprise a selected group of postmenopausal women. This type of preselection will not affect the validity of the study (no selection bias) because randomisation is aimed to ensure comparability of intervention and control group but it may limit the generalisability. For example, since we exclude lean women and women not using hormone replacement therapy, the results might not be generalised to these groups of women.So far, one study (PATH study) has been published on the effects of exercise interventions on sex steroid concentration in women . The PATIn summary, this paper shows the rationale and design of the SHAPE study. The SHAPE study aims to unravel the mechanisms underlying the association physical activity and breast cancer risk. Furthermore, this study evaluates the feasibility of delivering an exercise programme for postmenopausal women.2max, Maximum Oxygen Uptake; ATC, Anatomical Therapeutic Chemical Classification SystemBMI, Body Mass Index; DEXA, Dual-Energy X-ray Absorptiometry; SHBG, Sex Hormone Binding Globulin; VOThe author(s) declare that they have no competing interests.EMM, PHMP and AJS designed the study, participated in the coordination of the study and writing of the article. All authors provided comments on the draft and have read the paper.The pre-publication history for this paper can be accessed here:"]}
{"representative": "Physical activity participation is low among blacks, and strategies are needed to successfully create immediate and sustained behavior change related to physical activity. Churches can play an important role in health promotion efforts among blacks because of their central role in spiritual guidance, communication, social support, and networking. This pilot study evaluated the feasibility and acceptability of implementing a physical activity program for sedentary black adults in churches.We used a preintervention/postintervention single-group design to evaluate the effect of a 3-month faith-based physical activity intervention on daily walking and moderate- and vigorous-intensity physical activity among sedentary blacks. Eighty-seven black adults participated in eight group sessions that included discussion of physical activity-related topics, an instructor-led physical activity session, and weekly incentives to promote physical activity. We used a questionnaire to assess moderate and vigorous physical activity in minutes per week at baseline and after 3 months. Walking was assessed weekly in steps per day by using a pedometer.2) reported 27 \u00b1 54 and 10 \u00b1 25 minutes per week in moderate-intensity and vigorous-intensity physical activity, respectively, and walked 4822 \u00b1 2351 steps per day at baseline. After 12 weeks, moderate- and vigorous-intensity physical activity increased by 67 \u00b1 78 and 44 \u00b1 66 minutes per week, respectively (P \u2264 .01), and daily walking increased by 1373 \u00b1 728 steps per day (P < .001).Participants (mean age, 52 yrs; mean body mass index, 35 kg/mThese data suggest that a faith-based physical activity intervention may be an appropriate strategy for increasing physical activity among sedentary black adults. Future research will determine the impact of this program in a randomized, controlled design. The benefits of increased physical activity (PA) have been well documented -4, yet nThe purpose of this study was to develop and test a faith-based PA program to increase participation in daily walking and moderate- and vigorous-intensity physical activity , particularly in bouts lasting 10 minutes or longer, among sedentary black adults. This study was funded as a part of a career development grant. Data collected during this study were intended to serve as pilot data for a proposal for a larger randomized, controlled trial to test the faith-based PA program compared with a control group.We conducted this study in a suburban community in North Carolina from March through October 2005. In September and October 2004, nine local church pastors participated in in-depth interviews and provided input on the design, development, and implementation strategies for health promotion programs in churches in general and a faith-based PA program specifically. Pastors were recruited from a list of pastors who attended (or sent a representative to) at least one of two luncheons held for ministers in the local community to determine potential strategies for health promotion and disease prevention among blacks.Data from in-depth interviews suggested that, in general, health was viewed as a concept that encompassed spiritual, physical, mental, and emotional health. Pastors indicated that they play a role in the health of their church congregants by setting an example for healthy living, imparting the knowledge that wholeness and health are essential parts of Christian character that enable one to do God's bidding and that the body is God's temple. They advocate, encourage, and support efforts to engage in healthy behaviors and to implement health-related programming within the church. Pastors provided suggestions for why their congregants were not physically active  as well as feedback on ways to successfully implement a faith-based intervention .We used information from the in-depth interviews to shape the study design and session content of the faith-based PA intervention. Because the pilot study was designed to determine the feasibility and acceptability of the intervention strategy, a preintervention and postintervention study design with no control group was used. This design was deemed the most acceptable for church pastors and is in line with previous research suggesting that a no- or low-attention control would not be well received by this population . The intParticipants maintained weekly logs of pedometer step counts, which were used to self-monitor walking, and received a weekly summary to track walking progress throughout the study. We used incentives to encourage participants to increase their daily MPA to at least 30 minutes by engaging in moderate-intensity walking. Although participants were not given specific targets to increase their steps per day, they were advised of the 10,000 steps recommendation for daily walking  and wereWe hired group leaders to lead the weekly intervention sessions at churches. The following characteristics were considered desirable for group leaders: 1) having a working knowledge of general health and wellness but not being currently employed as a health educator, 2) being physically active but not exceptionally athletic, 3) having previous experience working with blacks and other groups in faith-based settings, 4) being comfortable speaking in group settings; and 5) not being a member of a church involved in the intervention. These criteria were selected to avoid hiring highly trained individuals, which might hamper the ability to disseminate this type of intervention to a larger audience, and to avoid potential biases by hiring church members because all four churches could not be represented in group leadership. Two black females were recruited as group leaders. Each group leader was assigned to lead sessions at two churches, depending on the time the church selected to hold the sessions and the availability of the group leader.Each church pastor also selected one church member to serve as a liaison between the church and the study staff and to attend to any church-related logistical issues. We paid church liaisons a modest honorarium for their participation in the study. In addition, church liaisons received a group leader training manual and session materials to facilitate continued implementation of the PA program after completion of the study. No additional incentives or compensation were provided to churches or pastors.or obtaining recommended MPA and VPA, but in bouts lasting less than 10 minutes, as assessed using a modified version of the International Physical Activity Questionnaire); 4) responding \u201cno\u201d to all questions on the Physical Activity Readiness Questionnaire (PAR-Q) or having obtained medical clearance; 5) having no other physical illnesses or disabilities limiting PA; and 6) being willing to commit to participating in weekly intervention sessions and all data collection visits. All individuals who attended an interest session received a pedometer, regardless of their eligibility for study participation. Eighty-seven participants met the eligibility criteria and were enrolled in the study.We selected a convenience sample of four churches that identified themselves as predominantly serving blacks and whose pastors participated in one of the previously mentioned ministers\u2019 luncheons. Recruitment for study participants was at the churches\u2019 discretion; it primarily consisted of making announcements during Sunday morning worship services and weekly activities and placing flyers throughout the church and in the Sunday bulletin. Interested individuals were invited to attend a general-interest session held at each church and led by the study\u2019s principal investigator (MCW). Interest sessions were held during the time the church had selected for the weekly intervention sessions. This limited the number of individuals who would be unable to attend the sessions regularly. During the interest session, the principal investigator explained the study procedures and eligibility criteria and answered participant questions. At the end of the interest session, participants were screened for study eligibility using the following criteria: 1) being self-identified as black; 2) being 18 years of age or older; 3) not currently meeting recommendations for MPA or VPA ; thus, to maximize the sample size available for data analysis, we used the average number of steps per day across weeks. In addition, we analyzed steps per day categorically: less than 5000 steps per day (sedentary); 5000 to 7499 (low active); 7500 to 9999 (somewhat active), 10,000 to 12,499 (active), and 12,500 or more (highly active) .Moderate- and vigorous-intensity physical activity. Self-reported participation by minutes per week in MPA, VPA, and walking was assessed using a modified version of the International Physical Activity Questionnaire (IPAQ) (e (IPAQ) . The IPAParticipant characteristics and anthropometrics. At the baseline visit, we used a questionnaire to measure self-perceived general health and well-being and presence of chronic diseases. Using a digital scale, we weighed each participant twice and measured a third time if the two measures differed by more than 0.2 kg. Height was also measured twice to the nearest 0.5 cm using a height stadiometer and measured a third time if the two measures differed by more than 0.5 cm. The average of the two closest measures was used for height and weight. Body mass index (BMI) was calculated as weight (kg) divided by height (m2). Seated resting blood pressure was measured, in duplicate, using a digital Omron monitor after participants had been seated with legs uncrossed for at least 5 minutes. Blood pressure was measured a third time if the two measures differed by more than 4 mm Hg. The two closest measures were averaged and used for analyses.Statistical analysis. Statistical analyses were performed using SAS version 8.2  and SAS-callable SUDAAN software . We examined the magnitude of the intra-class correlation coefficient (ICC) among subjects from the same church, which was estimated to be 0.06. We used a SUDAAN modeling procedure with two levels of clustering  to account for the ICC among church members and temporal dependence in repeated observations obtained on the same individual. Working independence between participants from the same church was assumed, along with an exchangeable covariance structure for repeated measurements on the same individual. Least square means were obtained from the models along with standard errors, which were then converted into standard deviations for the adjusted mean changes.2; range, 16.1 to 63.3 kg/m2; 69% of participants had BMIs \u226530 kg/m2). All participants were black, most were female (89%), almost half (49%) were married, and most (96%) had a high school-level education or higher. Eighty-five percent of study participants reported at least one chronic health condition. Almost half (43%) of study participants reported using antihypertensive agents, and the mean systolic/diastolic blood pressure levels of study participants were in the borderline hypertension range (137 \u00b1 23 mm Hg systolic and 84 \u00b1 14 mm Hg diastolic). The four churches included in the intervention were similar across all baseline characteristics with the exception of education (P < .01).At baseline, participants (n = 87) were 52 \u00b1 14 years of age  with an average BMI in the obese category . Most pP = .04). The increase in steps per day was 1373 \u00b1 728 steps (a 28% increase) after 12 weeks to an average of 6148 \u00b1 2534 steps per day (P < .01). Although our sample size was not large enough to detect statistically significant differences, we observed a decrease in the proportion of participants who were categorized as sedentary , and an increase in the proportion of participants who were classified as somewhat active . There was an increase from baseline to 4 weeks in the proportion of participants who were classified as active (from 1% to 4%), but no additional change was observed after 12 weeks (4% classified as active). Participants also reported increases in self-reported minutes per week in MPA  and VPA . Weight and BMI remained stable over the 12-week intervention (data not shown). Changes in systolic and diastolic blood pressure after 3 months were in the expected direction  but were not statistically significant (data not shown).Data on mean changes in study outcome variables are presented in We observed statistically significant increases in number of steps per day after 4 weeks and after 12 weeks, and significant changes in MPA and VPA after 12 weeks. We were encouraged to see that the proportion of participants who were classified as sedentary on the basis of previously published criteria for evaluating steps per day  decreaseFindings from our study regarding changes in PA among blacks are in line with, and in some cases show better results than, studies with similar time frames and study designs. An uncontrolled community-based walking program among 24 black breast-cancer survivors (aged 47 to 66 years) included eight 75-minute weekly sessions held at either a community center or a local church . The stuNot surprisingly, we did not observe significant changes in blood pressure in our study. The pilot study had a large enough sample to test meaningful differences in daily walking as assessed by a pedometer but was not large enough to be able to detect small changes in blood pressure. We were encouraged, however, to see trends in the appropriate direction for these variables. We were also not surprised that weight did not change in the current study. Hill et al suggest that small changes in behavior, such as adding an extra 2000 to 2500 steps per day, may prevent excess weight gain . ChangesOur study had a number of limitations. First, because we were unclear about the feasibility of the proposed study design and because of the reluctance in some faith-based communities to be part of a randomized study, particularly to a no-attention control group, we did not use a randomized, controlled design. We recognize the lack of a control group as a major limitation of the study. Second, this study's sample group was small; additional participants may have improved our ability to detect differences in clinical variables. Third, we did not have objective data for participation in MPA and VPA. We attempted to collect these data using accelerometers but encountered several issues related to adherence to the accelerometer data collection protocol and, thus, were not able to use these data for analyses. Finally, we are aware that participants who enrolled in our study might differ from the general population, from individuals who do not attend church, and from individuals who chose not to volunteer for the study.The study also had several strengths. Although we were unable to obtain an objective measure of MPA and VPA, we were able to collect this information using a self-reported questionnaire. Although self-reported PA data tend to be overestimated, increases in MPA and VPA in our study were in line with increases in objectively measured PA. We addressed some limitations of previous studies by incorporating tenets of the church and by involving the church in intervention development. Participants reported high satisfaction with the intervention, suggesting that this strategy might be successful in other black churches. At least one church used the materials to conduct a second set of intervention classes with new participants. Although we did not collect outcome data on the new participants, anecdotal evidence suggests that the program was well accepted in the second set of classes. Group leaders were able to implement the program on their own, suggesting that the program strategy may be sustainable. Finally, the current pilot study found that participants increased their number of steps per day and approached the level suggested to prevent weight gain .These data suggest that a faith-based PA intervention may be an appropriate strategy for increasing PA among sedentary black adults. Future research will determine the impact of this program compared with a control group. We plan to conduct a randomized, controlled trial to compare the faith-based PA intervention with a control condition.", "texts": ["Physical activity participation is low among blacks, and strategies are needed to successfully create immediate and sustained behavior change related to physical activity. Churches can play an important role in health promotion efforts among blacks because of their central role in spiritual guidance, communication, social support, and networking. This pilot study evaluated the feasibility and acceptability of implementing a physical activity program for sedentary black adults in churches.We used a preintervention/postintervention single-group design to evaluate the effect of a 3-month faith-based physical activity intervention on daily walking and moderate- and vigorous-intensity physical activity among sedentary blacks. Eighty-seven black adults participated in eight group sessions that included discussion of physical activity-related topics, an instructor-led physical activity session, and weekly incentives to promote physical activity. We used a questionnaire to assess moderate and vigorous physical activity in minutes per week at baseline and after 3 months. Walking was assessed weekly in steps per day by using a pedometer.2) reported 27 \u00b1 54 and 10 \u00b1 25 minutes per week in moderate-intensity and vigorous-intensity physical activity, respectively, and walked 4822 \u00b1 2351 steps per day at baseline. After 12 weeks, moderate- and vigorous-intensity physical activity increased by 67 \u00b1 78 and 44 \u00b1 66 minutes per week, respectively (P \u2264 .01), and daily walking increased by 1373 \u00b1 728 steps per day (P < .001).Participants (mean age, 52 yrs; mean body mass index, 35 kg/mThese data suggest that a faith-based physical activity intervention may be an appropriate strategy for increasing physical activity among sedentary black adults. Future research will determine the impact of this program in a randomized, controlled design. The benefits of increased physical activity (PA) have been well documented -4, yet nThe purpose of this study was to develop and test a faith-based PA program to increase participation in daily walking and moderate- and vigorous-intensity physical activity , particularly in bouts lasting 10 minutes or longer, among sedentary black adults. This study was funded as a part of a career development grant. Data collected during this study were intended to serve as pilot data for a proposal for a larger randomized, controlled trial to test the faith-based PA program compared with a control group.We conducted this study in a suburban community in North Carolina from March through October 2005. In September and October 2004, nine local church pastors participated in in-depth interviews and provided input on the design, development, and implementation strategies for health promotion programs in churches in general and a faith-based PA program specifically. Pastors were recruited from a list of pastors who attended (or sent a representative to) at least one of two luncheons held for ministers in the local community to determine potential strategies for health promotion and disease prevention among blacks.Data from in-depth interviews suggested that, in general, health was viewed as a concept that encompassed spiritual, physical, mental, and emotional health. Pastors indicated that they play a role in the health of their church congregants by setting an example for healthy living, imparting the knowledge that wholeness and health are essential parts of Christian character that enable one to do God's bidding and that the body is God's temple. They advocate, encourage, and support efforts to engage in healthy behaviors and to implement health-related programming within the church. Pastors provided suggestions for why their congregants were not physically active  as well as feedback on ways to successfully implement a faith-based intervention .We used information from the in-depth interviews to shape the study design and session content of the faith-based PA intervention. Because the pilot study was designed to determine the feasibility and acceptability of the intervention strategy, a preintervention and postintervention study design with no control group was used. This design was deemed the most acceptable for church pastors and is in line with previous research suggesting that a no- or low-attention control would not be well received by this population . The intParticipants maintained weekly logs of pedometer step counts, which were used to self-monitor walking, and received a weekly summary to track walking progress throughout the study. We used incentives to encourage participants to increase their daily MPA to at least 30 minutes by engaging in moderate-intensity walking. Although participants were not given specific targets to increase their steps per day, they were advised of the 10,000 steps recommendation for daily walking  and wereWe hired group leaders to lead the weekly intervention sessions at churches. The following characteristics were considered desirable for group leaders: 1) having a working knowledge of general health and wellness but not being currently employed as a health educator, 2) being physically active but not exceptionally athletic, 3) having previous experience working with blacks and other groups in faith-based settings, 4) being comfortable speaking in group settings; and 5) not being a member of a church involved in the intervention. These criteria were selected to avoid hiring highly trained individuals, which might hamper the ability to disseminate this type of intervention to a larger audience, and to avoid potential biases by hiring church members because all four churches could not be represented in group leadership. Two black females were recruited as group leaders. Each group leader was assigned to lead sessions at two churches, depending on the time the church selected to hold the sessions and the availability of the group leader.Each church pastor also selected one church member to serve as a liaison between the church and the study staff and to attend to any church-related logistical issues. We paid church liaisons a modest honorarium for their participation in the study. In addition, church liaisons received a group leader training manual and session materials to facilitate continued implementation of the PA program after completion of the study. No additional incentives or compensation were provided to churches or pastors.or obtaining recommended MPA and VPA, but in bouts lasting less than 10 minutes, as assessed using a modified version of the International Physical Activity Questionnaire); 4) responding \u201cno\u201d to all questions on the Physical Activity Readiness Questionnaire (PAR-Q) or having obtained medical clearance; 5) having no other physical illnesses or disabilities limiting PA; and 6) being willing to commit to participating in weekly intervention sessions and all data collection visits. All individuals who attended an interest session received a pedometer, regardless of their eligibility for study participation. Eighty-seven participants met the eligibility criteria and were enrolled in the study.We selected a convenience sample of four churches that identified themselves as predominantly serving blacks and whose pastors participated in one of the previously mentioned ministers\u2019 luncheons. Recruitment for study participants was at the churches\u2019 discretion; it primarily consisted of making announcements during Sunday morning worship services and weekly activities and placing flyers throughout the church and in the Sunday bulletin. Interested individuals were invited to attend a general-interest session held at each church and led by the study\u2019s principal investigator (MCW). Interest sessions were held during the time the church had selected for the weekly intervention sessions. This limited the number of individuals who would be unable to attend the sessions regularly. During the interest session, the principal investigator explained the study procedures and eligibility criteria and answered participant questions. At the end of the interest session, participants were screened for study eligibility using the following criteria: 1) being self-identified as black; 2) being 18 years of age or older; 3) not currently meeting recommendations for MPA or VPA ; thus, to maximize the sample size available for data analysis, we used the average number of steps per day across weeks. In addition, we analyzed steps per day categorically: less than 5000 steps per day (sedentary); 5000 to 7499 (low active); 7500 to 9999 (somewhat active), 10,000 to 12,499 (active), and 12,500 or more (highly active) .Moderate- and vigorous-intensity physical activity. Self-reported participation by minutes per week in MPA, VPA, and walking was assessed using a modified version of the International Physical Activity Questionnaire (IPAQ) (e (IPAQ) . The IPAParticipant characteristics and anthropometrics. At the baseline visit, we used a questionnaire to measure self-perceived general health and well-being and presence of chronic diseases. Using a digital scale, we weighed each participant twice and measured a third time if the two measures differed by more than 0.2 kg. Height was also measured twice to the nearest 0.5 cm using a height stadiometer and measured a third time if the two measures differed by more than 0.5 cm. The average of the two closest measures was used for height and weight. Body mass index (BMI) was calculated as weight (kg) divided by height (m2). Seated resting blood pressure was measured, in duplicate, using a digital Omron monitor after participants had been seated with legs uncrossed for at least 5 minutes. Blood pressure was measured a third time if the two measures differed by more than 4 mm Hg. The two closest measures were averaged and used for analyses.Statistical analysis. Statistical analyses were performed using SAS version 8.2  and SAS-callable SUDAAN software . We examined the magnitude of the intra-class correlation coefficient (ICC) among subjects from the same church, which was estimated to be 0.06. We used a SUDAAN modeling procedure with two levels of clustering  to account for the ICC among church members and temporal dependence in repeated observations obtained on the same individual. Working independence between participants from the same church was assumed, along with an exchangeable covariance structure for repeated measurements on the same individual. Least square means were obtained from the models along with standard errors, which were then converted into standard deviations for the adjusted mean changes.2; range, 16.1 to 63.3 kg/m2; 69% of participants had BMIs \u226530 kg/m2). All participants were black, most were female (89%), almost half (49%) were married, and most (96%) had a high school-level education or higher. Eighty-five percent of study participants reported at least one chronic health condition. Almost half (43%) of study participants reported using antihypertensive agents, and the mean systolic/diastolic blood pressure levels of study participants were in the borderline hypertension range (137 \u00b1 23 mm Hg systolic and 84 \u00b1 14 mm Hg diastolic). The four churches included in the intervention were similar across all baseline characteristics with the exception of education (P < .01).At baseline, participants (n = 87) were 52 \u00b1 14 years of age  with an average BMI in the obese category . Most pP = .04). The increase in steps per day was 1373 \u00b1 728 steps (a 28% increase) after 12 weeks to an average of 6148 \u00b1 2534 steps per day (P < .01). Although our sample size was not large enough to detect statistically significant differences, we observed a decrease in the proportion of participants who were categorized as sedentary , and an increase in the proportion of participants who were classified as somewhat active . There was an increase from baseline to 4 weeks in the proportion of participants who were classified as active (from 1% to 4%), but no additional change was observed after 12 weeks (4% classified as active). Participants also reported increases in self-reported minutes per week in MPA  and VPA . Weight and BMI remained stable over the 12-week intervention (data not shown). Changes in systolic and diastolic blood pressure after 3 months were in the expected direction  but were not statistically significant (data not shown).Data on mean changes in study outcome variables are presented in We observed statistically significant increases in number of steps per day after 4 weeks and after 12 weeks, and significant changes in MPA and VPA after 12 weeks. We were encouraged to see that the proportion of participants who were classified as sedentary on the basis of previously published criteria for evaluating steps per day  decreaseFindings from our study regarding changes in PA among blacks are in line with, and in some cases show better results than, studies with similar time frames and study designs. An uncontrolled community-based walking program among 24 black breast-cancer survivors (aged 47 to 66 years) included eight 75-minute weekly sessions held at either a community center or a local church . The stuNot surprisingly, we did not observe significant changes in blood pressure in our study. The pilot study had a large enough sample to test meaningful differences in daily walking as assessed by a pedometer but was not large enough to be able to detect small changes in blood pressure. We were encouraged, however, to see trends in the appropriate direction for these variables. We were also not surprised that weight did not change in the current study. Hill et al suggest that small changes in behavior, such as adding an extra 2000 to 2500 steps per day, may prevent excess weight gain . ChangesOur study had a number of limitations. First, because we were unclear about the feasibility of the proposed study design and because of the reluctance in some faith-based communities to be part of a randomized study, particularly to a no-attention control group, we did not use a randomized, controlled design. We recognize the lack of a control group as a major limitation of the study. Second, this study's sample group was small; additional participants may have improved our ability to detect differences in clinical variables. Third, we did not have objective data for participation in MPA and VPA. We attempted to collect these data using accelerometers but encountered several issues related to adherence to the accelerometer data collection protocol and, thus, were not able to use these data for analyses. Finally, we are aware that participants who enrolled in our study might differ from the general population, from individuals who do not attend church, and from individuals who chose not to volunteer for the study.The study also had several strengths. Although we were unable to obtain an objective measure of MPA and VPA, we were able to collect this information using a self-reported questionnaire. Although self-reported PA data tend to be overestimated, increases in MPA and VPA in our study were in line with increases in objectively measured PA. We addressed some limitations of previous studies by incorporating tenets of the church and by involving the church in intervention development. Participants reported high satisfaction with the intervention, suggesting that this strategy might be successful in other black churches. At least one church used the materials to conduct a second set of intervention classes with new participants. Although we did not collect outcome data on the new participants, anecdotal evidence suggests that the program was well accepted in the second set of classes. Group leaders were able to implement the program on their own, suggesting that the program strategy may be sustainable. Finally, the current pilot study found that participants increased their number of steps per day and approached the level suggested to prevent weight gain .These data suggest that a faith-based PA intervention may be an appropriate strategy for increasing PA among sedentary black adults. Future research will determine the impact of this program compared with a control group. We plan to conduct a randomized, controlled trial to compare the faith-based PA intervention with a control condition."]}
{"representative": "Concentrations of plasma \u03b2-carotene and lutein declined in both the groups during the postpartum period but the decline was significantly less in the supplemented than in the control women at one month ; lutein -0.26 vs -0.49 \u03bcmol/L, p<0.05) and three months . Concentration of breastmilk retinol was also significantly greater in the supplemented group at three months postpartum than in the controls . Concentrations of infants\u2019 plasma retinol, \u03b2-carotene, and lutein, measured at six months of age, did not differ between the groups. Fat supplementation during pregnancy and lactation in women with a very low intake of dietary fat has beneficial effects on maternal postpartum vitamin A status.Dietary fat intake is extremely low in most communities with vitamin A deficiency. However, its role in vitamin A status of pregnant and lactating women is poorly understood. The aim of the study was to examine the effect of supplementing women with fat from mid-/late pregnancy until six months postpartum on their vitamin A status and that of their infants. Women recruited at 5-7 months of gestation were supplemented daily with 20 mL of soybean-oil (n=248) until six months postpartum or received no supplement (n=251). Dietary fat intake was assessed by 24-hour dietary recall at enrollment and at 1, 3 and 6 months postpartum. Concentrations of maternal plasma retinol, \u03b2-carotene, and lutein were measured at enrollment and at 1, 3 and 6 months postpartum, and those of infants at six months postpartum. Concentration of breastmilk retinol was measured at 1, 3 and 6 months postpartum. The change in concentration of plasma retinol at three months postpartum compared to pregnancy was significantly higher in the supplemented compared to the control women  Vitamin A deficiency among pregnant and lactating women is widely prevalent in many developing countries \u20133 and poConventional approaches to combat vitamin A deficiency include periodic supplementation with vitamin A, fortification of foods, and a food-based approach with increased consumption of dark green-leafy vegetables. Among the intervention strategies, the dietary approach with an emphasis on increased consumption of provitamin A carotenoid-containing foods has been advocated as a preferable and sustainable strategy to eliminate vitamin A deficiency ,7. HowevStudies to date investigating the relationship between dietary fat and vitamin A status have been limited to investigations of efficacy in highly-controlled settings with a relatively-small number of subjects. Studies in children have shown that fat supplementation enhances the absorption of \u03b2-carotene and improves the vitamin A status . A studyThis community-based controlled trial was conducted from November 1995 to October 1997 in 16 villages in Matlab upazila (subdistrict) of Chandpur district, Bangladesh. The area, located approximately 55 km southeast of the capital city of Bangladesh\u2014Dhaka, considered to be typical of rural and riverine delta areas . The usuSixteen socioeconomically-similar villages were grouped into two sets of eight each, separated by a distance of about 2 km. One set of villages was randomly selected for dietary intervention. It was felt that randomization of half of each selected area will have the same effect as would individual randomization in that both intervention and control groups will come from the same geographical area and community as each other. Therefore, any area-level effects are accounted for by the research design. The study participants were healthy pregnant women in their early or mid-pregnancy identified through menstrual history. A survey was conducted in the study villages to identify all currently-eligible women and also to list all married women of childbearing age, who could potentially become pregnant. A field team consisting of a health assistant, a community health worker (CHW), a dietary interviewer , and a porter visited each eligible subject at home and explained the study and meaning of their voluntary participation. A detailed interview on socioeconomic, demographic and household characteristics was conducted. Trained and experienced field workers measured body-weight, height, mid-upper arm circumference (MUAC) following standard procedures . Data onDuring the study period, 341 and 335 women were recruited from the intervention and control villages respectively . From thThe intervention consisted of unfortified soybean-oil supplied to the women in the intervention villages. The women in the control villages were not given any other dietary supplement or advice and maintained their usual diet. Each woman in the intervention villages was supplied with a weekly ration of 140 mL of soybean-oil and was asked to consume 10 mL of oil twice a day  with their main meals  as supplement. The community health worker (CHW) delivered the oil in a plastic bottle and a clearly-marked (at 10 mL) plastic dispenser to ensure the dose to each study woman in the home. Women were given several options to consume the supplement that included mixing of the oil with their foods, drinking during the meal, or frying their portion of the meal with the oil. However, pre-testing revealed that drinking during the meal was the most preferred choice of supplement intake, followed by mixing the oil directly with their meal portion. The study was, therefore, designed to supplement the diet in this way rather than instructing women to add oil during preparation of household food to ensure a measured \u2018dose\u2019 of oil for more accurate quantification of supplement intake. The total period of oil supplementation in an individual woman ranged from 8 to 10 months depending on the gestational ages of women at enrollment. The participants in the control group were not given any extra food to balance energy between the groups.Motivational efforts were continued throughout the study period to maximize high compliance to the intervention and to avoid any replacement of the usual diet by the supplement. Each subject was trained to maintain the daily record of oil intake using an easily-understandable record-keeping sheet supplied each time the oil was delivered. The CHWs collected the records of oil intake during their next weekly home-visits, and they supplied the participant with another bottle of oil for the ensuing week. They also interviewed the subject and obtained information about her attitudes towards and compliance to the oil during the previous one week.Fat intake from all sources was estimated by 24-hour dietary recall administered four times during the study period following standard guidelines . A surveData on nutrient intake were calculated using a computerized food-composition table for Bangladeshi foods, which used nutrient data from regional food-composition databases ,25. The Blood samples each of 0.5 mL were collected in lithium heparinized microtainers either by finger-prick or ante-cubital venipuncture, immediately put on ice, shielded from light in a cold carrier, and transported to the field laboratory within 3-6 hours of collection. Plasma was then separated by centrifugation  and transferred to labelled screw-top, amber-coloured cryovials and stored at -20 \u00b0C for 2-4 weeks in the field laboratory before being transferred to the central laboratory in Dhaka for storage at -7 \u00b0C until analysis 2-3 months later. Simultaneous determination of concentrations of serum retinol, lutein, and \u03b2-carotene was done by high-performance liquid chromatography (HPLC) in the Nutritional Biochemistry Laboratory of ICDDR,B . RetinolA nurse or a trained interviewer collected a casual breastmilk sample according to the method previously used in this population . Breastmt-test for statistical significance. Changes in each of the outcome variables from baseline (pregnancy) to different follow-up periods were calculated for each subject by subtraction. Paired t-test was used for comparing within-group differences from baseline to the respective time periods. Independent sample t-tests were used for comparing changes at respective study periods between the groups. Concentrations of breastmilk retinol were compared between the intervention group and the control group by independent sample t-test of means. In this case, the change was not examined or tested as the intervention had been continuing for a certain period before the first sample of breastmilk was collected. The mean concentrations of infants\u2019 plasma retinol, \u03b2-carotene, and lutein were compared between the groups by the independent sample t-test. The p value of <0.05 was considered statistically significant.Numeric variables were examined for their distribution outliers, and extreme values were identified and excluded from the analyses. Such values did not exceed 3-4% of the observations. Results are presented as mean\u00b1standard deviation for the normally-distributed variables or median and interquartile range for the variables not normally distributed. The differences between the groups were examined by Student's The Ethical Review Committee of ICDDR,B approved the study. An informed written consent was obtained from each woman before enrollment into the study.The baseline characteristics of 248 supplemented and 251 control women are presented in As expected, the mean fat intake from all the sources (including supplement) was significantly higher in the intervention group at 1, 3 and 6 months postpartum than that of the control group . Fat intCompared to the pregnancy (baseline) level, concentrations of plasma retinol increased in the intervention women in all the three measurement periods during the postpartum period ; however, the change at one month postpartum reached statistical significance . In the During the postpartum months, the concentration of plasma \u03b2-carotene declined compared to the pregnancy level in both intervention and control groups . The decThe concentration of plasma lutein also declined during the postpartum measurements and followed the same trend as that observed in \u03b2-carotene . HoweverThe mean concentrations of breastmilk retinol were higher in the intervention group than those in the control group at one month and three months postpartum (0.06 and 0.13 \u03bcmol/L respectively), and the difference was significant at three months postpartum but not at six months postpartum . No signThe aim of this study was to examine the effect of supplementation of dietary fat on the vitamin A status of pregnant and lactating women and their infants in a population where vitamin A deficiency is prevalent and dietary fat intake is low. As indicated by the improvement in concentrations of blood retinol and carotenoids and the improvement in concentrations of breastmilk retinol in the supplemented group, these findings suggest that increasing the dietary fat intake may have beneficial effect on the vitamin A status of women during early lactation.In this study, we aimed at increasing the fat intake by 18 g per day in the intervention group but the actual increase was less in many individual women. This was not unexpected since administration of the supplement was ultimately controlled by the study subjects themselves and not by the study team. Further, consumption of oil in this way, i.e. in a medicinal dosing, is not a normal dietary practice. Nonetheless, supplementation resulted in a doubling or greater fat intake in the intervention group.The supplemented group increased concentrations of plasma retinol at 1, 3 and 6 months postpartum measurements  while an increase in the control group was observed only at one month postpartum measurement (5%) and a slightly declining tendency was noted at three and six months postpartum (-8 and -1%). The change compared to the baseline level at one month postpartum in the intervention was statistically significant, suggesting that dietary fat had a positive effect on plasma retinol concentration of the supplemented women. Both the groups showed lower concentrations of plasma \u03b2-carotene and lutein during postpartum; however, relatively less so in the supplemented group, indicating higher provitamin A bioavailability in the oil-supplemented women. These findings are consistent with earlier reports that fat supplementation in deficient population has beneficial effects on concentrations of retinol and carotenoids ,30,31.In the study population, dietary vitamin A is derived almost entirely from plant sources ,32. TherThe women in the supplemented group of our study had relatively higher concentrations of breastmilk retinol at one month and three months postpartum than those in the control group. The increase in concentration of breastmilk retinol in the supplemented group translates into 8-18 \u03bcg of daily additional preformed retinol delivery in their infants (assuming a breastmilk intake of 700 mL per day), an amount equivalent to 4-10% of the basal requirements for infants up to the age of six months ,36,37. AOur findings are consistent with those of other studies in developing countries where the breastmilk retinol level is either deficient or at the marginal range ,38. Of iWe have observed a substantial fluctuation in concentrations of breastmilk retinol. Such fluctuations in concentrations of breastmilk retinol have also been reported by others . It is aNo difference was observed in concentrations of the infants\u2019 plasma retinol, \u03b2-carotene, or lutein. Possible reason might be that vitamin A status of the infants was measured at the end of six months of age when the difference in maternal vitamin A status between the supplemented and the control mothers did not exist. It might also be possible that the benefit to the infants of the intervention mothers, if it had occurred in early infancy, might not have been large enough to maintain a sustained higher concentration up to six months of age. Although the intervention mothers had a better concentration of breastmilk retinol during early lactation, it is notable that retinol concentration in most women of both the groups was always less than 1.05 \u03bcmol/L, the concentration considered to be just enough to meet the basal requirement of the infant but not enough to build good vitamin A stores . ICDDR,B acknowledges with gratitude the commitment of USAID/OMNI to the Centre's research efforts. Financial support from the Division of Human Nutrition and Epidemiology, Wageningen, is gratefully acknowledged. The authors thank all the mother-infant pairs for their valuable participation in the study.", "texts": ["Concentrations of plasma \u03b2-carotene and lutein declined in both the groups during the postpartum period but the decline was significantly less in the supplemented than in the control women at one month ; lutein -0.26 vs -0.49 \u03bcmol/L, p<0.05) and three months . Concentration of breastmilk retinol was also significantly greater in the supplemented group at three months postpartum than in the controls . Concentrations of infants\u2019 plasma retinol, \u03b2-carotene, and lutein, measured at six months of age, did not differ between the groups. Fat supplementation during pregnancy and lactation in women with a very low intake of dietary fat has beneficial effects on maternal postpartum vitamin A status.Dietary fat intake is extremely low in most communities with vitamin A deficiency. However, its role in vitamin A status of pregnant and lactating women is poorly understood. The aim of the study was to examine the effect of supplementing women with fat from mid-/late pregnancy until six months postpartum on their vitamin A status and that of their infants. Women recruited at 5-7 months of gestation were supplemented daily with 20 mL of soybean-oil (n=248) until six months postpartum or received no supplement (n=251). Dietary fat intake was assessed by 24-hour dietary recall at enrollment and at 1, 3 and 6 months postpartum. Concentrations of maternal plasma retinol, \u03b2-carotene, and lutein were measured at enrollment and at 1, 3 and 6 months postpartum, and those of infants at six months postpartum. Concentration of breastmilk retinol was measured at 1, 3 and 6 months postpartum. The change in concentration of plasma retinol at three months postpartum compared to pregnancy was significantly higher in the supplemented compared to the control women  Vitamin A deficiency among pregnant and lactating women is widely prevalent in many developing countries \u20133 and poConventional approaches to combat vitamin A deficiency include periodic supplementation with vitamin A, fortification of foods, and a food-based approach with increased consumption of dark green-leafy vegetables. Among the intervention strategies, the dietary approach with an emphasis on increased consumption of provitamin A carotenoid-containing foods has been advocated as a preferable and sustainable strategy to eliminate vitamin A deficiency ,7. HowevStudies to date investigating the relationship between dietary fat and vitamin A status have been limited to investigations of efficacy in highly-controlled settings with a relatively-small number of subjects. Studies in children have shown that fat supplementation enhances the absorption of \u03b2-carotene and improves the vitamin A status . A studyThis community-based controlled trial was conducted from November 1995 to October 1997 in 16 villages in Matlab upazila (subdistrict) of Chandpur district, Bangladesh. The area, located approximately 55 km southeast of the capital city of Bangladesh\u2014Dhaka, considered to be typical of rural and riverine delta areas . The usuSixteen socioeconomically-similar villages were grouped into two sets of eight each, separated by a distance of about 2 km. One set of villages was randomly selected for dietary intervention. It was felt that randomization of half of each selected area will have the same effect as would individual randomization in that both intervention and control groups will come from the same geographical area and community as each other. Therefore, any area-level effects are accounted for by the research design. The study participants were healthy pregnant women in their early or mid-pregnancy identified through menstrual history. A survey was conducted in the study villages to identify all currently-eligible women and also to list all married women of childbearing age, who could potentially become pregnant. A field team consisting of a health assistant, a community health worker (CHW), a dietary interviewer , and a porter visited each eligible subject at home and explained the study and meaning of their voluntary participation. A detailed interview on socioeconomic, demographic and household characteristics was conducted. Trained and experienced field workers measured body-weight, height, mid-upper arm circumference (MUAC) following standard procedures . Data onDuring the study period, 341 and 335 women were recruited from the intervention and control villages respectively . From thThe intervention consisted of unfortified soybean-oil supplied to the women in the intervention villages. The women in the control villages were not given any other dietary supplement or advice and maintained their usual diet. Each woman in the intervention villages was supplied with a weekly ration of 140 mL of soybean-oil and was asked to consume 10 mL of oil twice a day  with their main meals  as supplement. The community health worker (CHW) delivered the oil in a plastic bottle and a clearly-marked (at 10 mL) plastic dispenser to ensure the dose to each study woman in the home. Women were given several options to consume the supplement that included mixing of the oil with their foods, drinking during the meal, or frying their portion of the meal with the oil. However, pre-testing revealed that drinking during the meal was the most preferred choice of supplement intake, followed by mixing the oil directly with their meal portion. The study was, therefore, designed to supplement the diet in this way rather than instructing women to add oil during preparation of household food to ensure a measured \u2018dose\u2019 of oil for more accurate quantification of supplement intake. The total period of oil supplementation in an individual woman ranged from 8 to 10 months depending on the gestational ages of women at enrollment. The participants in the control group were not given any extra food to balance energy between the groups.Motivational efforts were continued throughout the study period to maximize high compliance to the intervention and to avoid any replacement of the usual diet by the supplement. Each subject was trained to maintain the daily record of oil intake using an easily-understandable record-keeping sheet supplied each time the oil was delivered. The CHWs collected the records of oil intake during their next weekly home-visits, and they supplied the participant with another bottle of oil for the ensuing week. They also interviewed the subject and obtained information about her attitudes towards and compliance to the oil during the previous one week.Fat intake from all sources was estimated by 24-hour dietary recall administered four times during the study period following standard guidelines . A surveData on nutrient intake were calculated using a computerized food-composition table for Bangladeshi foods, which used nutrient data from regional food-composition databases ,25. The Blood samples each of 0.5 mL were collected in lithium heparinized microtainers either by finger-prick or ante-cubital venipuncture, immediately put on ice, shielded from light in a cold carrier, and transported to the field laboratory within 3-6 hours of collection. Plasma was then separated by centrifugation  and transferred to labelled screw-top, amber-coloured cryovials and stored at -20 \u00b0C for 2-4 weeks in the field laboratory before being transferred to the central laboratory in Dhaka for storage at -7 \u00b0C until analysis 2-3 months later. Simultaneous determination of concentrations of serum retinol, lutein, and \u03b2-carotene was done by high-performance liquid chromatography (HPLC) in the Nutritional Biochemistry Laboratory of ICDDR,B . RetinolA nurse or a trained interviewer collected a casual breastmilk sample according to the method previously used in this population . Breastmt-test for statistical significance. Changes in each of the outcome variables from baseline (pregnancy) to different follow-up periods were calculated for each subject by subtraction. Paired t-test was used for comparing within-group differences from baseline to the respective time periods. Independent sample t-tests were used for comparing changes at respective study periods between the groups. Concentrations of breastmilk retinol were compared between the intervention group and the control group by independent sample t-test of means. In this case, the change was not examined or tested as the intervention had been continuing for a certain period before the first sample of breastmilk was collected. The mean concentrations of infants\u2019 plasma retinol, \u03b2-carotene, and lutein were compared between the groups by the independent sample t-test. The p value of <0.05 was considered statistically significant.Numeric variables were examined for their distribution outliers, and extreme values were identified and excluded from the analyses. Such values did not exceed 3-4% of the observations. Results are presented as mean\u00b1standard deviation for the normally-distributed variables or median and interquartile range for the variables not normally distributed. The differences between the groups were examined by Student's The Ethical Review Committee of ICDDR,B approved the study. An informed written consent was obtained from each woman before enrollment into the study.The baseline characteristics of 248 supplemented and 251 control women are presented in As expected, the mean fat intake from all the sources (including supplement) was significantly higher in the intervention group at 1, 3 and 6 months postpartum than that of the control group . Fat intCompared to the pregnancy (baseline) level, concentrations of plasma retinol increased in the intervention women in all the three measurement periods during the postpartum period ; however, the change at one month postpartum reached statistical significance . In the During the postpartum months, the concentration of plasma \u03b2-carotene declined compared to the pregnancy level in both intervention and control groups . The decThe concentration of plasma lutein also declined during the postpartum measurements and followed the same trend as that observed in \u03b2-carotene . HoweverThe mean concentrations of breastmilk retinol were higher in the intervention group than those in the control group at one month and three months postpartum (0.06 and 0.13 \u03bcmol/L respectively), and the difference was significant at three months postpartum but not at six months postpartum . No signThe aim of this study was to examine the effect of supplementation of dietary fat on the vitamin A status of pregnant and lactating women and their infants in a population where vitamin A deficiency is prevalent and dietary fat intake is low. As indicated by the improvement in concentrations of blood retinol and carotenoids and the improvement in concentrations of breastmilk retinol in the supplemented group, these findings suggest that increasing the dietary fat intake may have beneficial effect on the vitamin A status of women during early lactation.In this study, we aimed at increasing the fat intake by 18 g per day in the intervention group but the actual increase was less in many individual women. This was not unexpected since administration of the supplement was ultimately controlled by the study subjects themselves and not by the study team. Further, consumption of oil in this way, i.e. in a medicinal dosing, is not a normal dietary practice. Nonetheless, supplementation resulted in a doubling or greater fat intake in the intervention group.The supplemented group increased concentrations of plasma retinol at 1, 3 and 6 months postpartum measurements  while an increase in the control group was observed only at one month postpartum measurement (5%) and a slightly declining tendency was noted at three and six months postpartum (-8 and -1%). The change compared to the baseline level at one month postpartum in the intervention was statistically significant, suggesting that dietary fat had a positive effect on plasma retinol concentration of the supplemented women. Both the groups showed lower concentrations of plasma \u03b2-carotene and lutein during postpartum; however, relatively less so in the supplemented group, indicating higher provitamin A bioavailability in the oil-supplemented women. These findings are consistent with earlier reports that fat supplementation in deficient population has beneficial effects on concentrations of retinol and carotenoids ,30,31.In the study population, dietary vitamin A is derived almost entirely from plant sources ,32. TherThe women in the supplemented group of our study had relatively higher concentrations of breastmilk retinol at one month and three months postpartum than those in the control group. The increase in concentration of breastmilk retinol in the supplemented group translates into 8-18 \u03bcg of daily additional preformed retinol delivery in their infants (assuming a breastmilk intake of 700 mL per day), an amount equivalent to 4-10% of the basal requirements for infants up to the age of six months ,36,37. AOur findings are consistent with those of other studies in developing countries where the breastmilk retinol level is either deficient or at the marginal range ,38. Of iWe have observed a substantial fluctuation in concentrations of breastmilk retinol. Such fluctuations in concentrations of breastmilk retinol have also been reported by others . It is aNo difference was observed in concentrations of the infants\u2019 plasma retinol, \u03b2-carotene, or lutein. Possible reason might be that vitamin A status of the infants was measured at the end of six months of age when the difference in maternal vitamin A status between the supplemented and the control mothers did not exist. It might also be possible that the benefit to the infants of the intervention mothers, if it had occurred in early infancy, might not have been large enough to maintain a sustained higher concentration up to six months of age. Although the intervention mothers had a better concentration of breastmilk retinol during early lactation, it is notable that retinol concentration in most women of both the groups was always less than 1.05 \u03bcmol/L, the concentration considered to be just enough to meet the basal requirement of the infant but not enough to build good vitamin A stores . ICDDR,B acknowledges with gratitude the commitment of USAID/OMNI to the Centre's research efforts. Financial support from the Division of Human Nutrition and Epidemiology, Wageningen, is gratefully acknowledged. The authors thank all the mother-infant pairs for their valuable participation in the study."]}
{"representative": "Refugee women have a high risk of coronary heart disease with low physical activity as one possible mediator. Furthermore, cultural and environmental barriers to increasing physical activity have been demonstrated. The aim of the study was to evaluate the combined effect of an approximate 6-month primary health care- and community-based exercise intervention versus an individual written prescription for exercise on objectively assessed cardiorespiratory fitness in low-active refugee women.Relative aerobic capacity and fitness level were assessed as the two main outcome measures.A controlled clinical trial, named \"Support for Increased Physical Activity\", was executed among 243 refugee women recruited between November 2006 and April 2008 from two deprived geographic areas in southern Stockholm, Sweden. One geographic area provided the intervention group and the other area the control group. The control group was on a higher activity level at both baseline and follow-up, which was taken into consideration in the analysis by applying statistical models that accounted for this. relative aerobic capacity and the percentage with an acceptable fitness level (relative aerobic capacity > 23 O2ml\u00b7kg\u00b7min-1) to a greater extent than the control group between baseline and the 6-month follow-up, after adjusting for possible confounders (P = 0.020).The intervention group increased their A combined primary health-care and community-based exercise programme (involving non-profit organizations) can be an effective strategy to increase cardiorespiratory fitness among low-active refugee women.ClinicalTrials.gov ID: NCT00747942 Demographic and economic changes have resulted in a more diverse population with greater social disparities in Sweden during the last few decades because of the large influx of refugees mainly from Latin America in the 1970 s, Iran in the 1980 s, Bosnia and the Balkans in the 1990 s, and Iraq and the Middle East in the 2000 s. Refugee status has previously been defined by the United Nations as a person who is outside the protection of his or hers country owing to a well-founded fear of being persecuted for reasons of race, religion, nationality, membership of a particular social group, or political opinion [New York Times Magazine provided data documenting the growing ethnic minority and socioeconomic segregation in urban and suburban Sweden [The large influx of refugees has changed Swedish society. A 2005 article in the Many of these refugees have an increased risk of coronary heart disease (CHD) in both men and women. Female refugees born in Turkey, Iran, and Iraq and settled in Sweden had an age-adjusted excess risk of CHD compared with Swedish-born controls ranging from 110% to 130% -7. Femal2max below the 50th percentile and were also obese [Although it is convenient to assess changes in physical activity with questionnaires, cardiovascular fitness is a more reliable and objective measure. For example, data from the longitudinal CARDIA study showed that a change in individual cardiorespiratory fitness is strongly associated with a corresponding change in habitual energy expenditure and leisure time physical activity . Furtherso obese .largest increase in physical activity levels can be found among the least active at baseline; minority groups were, however, not included in that study [Physical inactivity and obesity are potential mediators of accelerating arteriosclerosis and the development of CHD seen among refugee women. According to the World Health Organization (WHO), it is important to target these risk factors in order to decrease the global burden of CHD. In addition, previous research has shown that the at study . Therefoat study . The finBoth individual and environmental factors are associated with physical activity in minority women. For example, a qualitative study from the United States showed that a lack of time due to caregiving duties, health worries, and lack of motivation were important barriers to women from ethnic minorities and refugee women becoming more physically active . The womThe real life situation of many refugee women in Sweden, such as low socioeconomic status, low educational status, and residing in a deprived and unsafe neighbourhood, has been associated with low levels of physical activity and exercise . In thisThe purpose of the present study was to investigate whether appropriate physical activities and social support can increase cardiorespiratory fitness in refugee women in Sweden. This purpose was implemented by evaluating the effect of an approximate 6-month primary health-care- and community-based exercise intervention versus an individual written prescription for exercise on objectively assessed cardiorespiratory fitness in low-active and overweight refugee women.St\u00f6d till Aktivare Motion or STAM in Swedish).This controlled clinical trial was named Support for Increased Physical Activity , to identify the two deprived and immigrant-dense geographic areas (including large populations of Middle East refugees). The CNI scores ranged from-76.4 (most affluent neighbourhood) to 53.5 (most deprived neighbourhood) . The CNIEligible for inclusion were women aged 25 through 64 who were first-generation refugees in Sweden from either the Middle East or Latin America, were overweight and reported low levels of physical activity during their leisure time  ,23. We eWe appealed to the community to obtain access to physical activity facilities for the intervention. Nine primary health care centres located in the two immigrant-dense areas were partly used in the recruitment processes. This process included information brochures in the waiting room but the women were also informed about the study by the personnel at the primary health care centres. We also recruited women through local advertising and via community organizations such as women's associations, child welfare centres, pre-schools, churches/mosques and courses in Swedish for immigrants.The women who were willing to participate filled in a first screening protocol. All women who filled in the screening protocol were contacted by research staff who could speak their native language. The participants were further informed about the study and those who agreed to participate and were eligible for inclusion were enrolled for a baseline assessment. Eligible for inclusion included 131 women in the intervention group and 112 women in the control group. All written material  was translated to Spanish or Arabic by two independent professional translators and backwards translated by two other professional translators.2(m) (according to WHO's recommendations) and comprised three categories: (1) normal weight (BMI < 25.0), (2) overweight (BMI 25.0-29.9) and (3) obesity (BMI \u2265 30).In total three questions were included in the screening protocol to assess physical activity, overweight/obesity, and pre-existing ill health. Physical activity was assessed by asking the participants how often they exercise during their leisure-time. The response alternatives were the following: (1) I get practically no exercise at all, (2) I exercise occasionally, (3) I exercise regularly, about once a week, (4) I exercise regularly, about twice a week and (5) I exercise regularly, quite vigorously at least twice a week. Overweight and obesity were assessed on the basis of self-reported data on weight and height. Body mass index (BMI) was calculated as weight(kg)/heightOur intention was to include only those who were inactive  and overweight/obese. However, around 10% in the intervention group and 50% in the control group were found to have a normal weight at the baseline measurements. They were not excluded from the study but we took BMI into account in the analyses.n = 114 women in the intervention group and 98 women in the control group) were assessed at baseline. Most women came from the Middle East: 96% and 80% in the intervention and control group, respectively. The women mainly came from the following countries: Iraq, Syria, Turkey, Lebanon and Chile. The largest groups in the intervention group came from Syria (26%) and Lebanon (10%) and the largest groups in the control group came from Turkey (26%) and Iraq (24%).Background information  was assessed at baseline. Height, weight and cardiorespiratory fitness were assessed at baseline and at 6 months. In total, 212 women  was given during the summer break. The women attended 16 sessions in average (range 1-32). An initial session of individual counselling with the purpose to strengthen self-efficacy, empowerment and personal motivation was given by a female physiotherapist who guided the women concerning how to start doing regular physical activities at a health-enhancing level and informed them about the benefits associated with physical activity. This initial session also addressed possible barriers to physical activity based on findings of a previous qualitative study, e.g. worries about palpitations, tiredness and sweating (15). The women received information about different levels of health-enhancing physical activity, such as moderate and vigorous physical activity and how they are related to perceived exertion . The womThe participants in the control group received an individual written prescription for exercise that was partly based on the results from the cardiorespiratory fitness together with an initial session of individual counselling. In general, the written prescription was based on the recommendation of regular health-enhancing physical activity, i.e. 30 minutes per day at a moderate intensity level ,30. The 2 l\u00b7min-1) were calculated by the bicycle computer, using the \u00c5strand-Rhyming nomogram (24). The data collectors in the present study were not blinded because we recruited the intervention and control groups from two different geographic areas.The \u00c5strand-Rhyming submaximal bicycle ergometer test was used to assess cardiorespiratory fitness . The MonOut of the 212 women who were assessed at baseline, 179 (84%) had at least one measurement either at baseline or at the six-month follow-up and they were included in the analysis (n = 91 in the intervention group and n = 88 in the control group). Most of the 33 excluded women were either not able to perform the test due to poor bicycling skills, or not able to bike at the correct speed, or had inadequate muscular strength to perform the test. A standardized walking test might have been an option; still, we believe that many of the women had too low a capacity to fit within any standardized protocol. The 33 excluded women did not differ with regard to age or BMI from those included.To sum up, 243 women (131 women in the intervention group and 112 women in the control group) showed an initial interest to take part in the study and were considered eligible. Of these women, 212 came to the baseline assessments (114 women in the intervention group and 98 women in the control group) and 179 had at least one measurement either at baseline or at the six-month follow-up (91 women in the intervention group and 88 women in the control group). All women in the intervention group took part in at least one session with a leader/instructor.relative aerobic capacity, defined as oxygen uptake per kilo body weight (O2ml\u00b7kg\u00b7min-1). The second outcome variable, fitness level, was dichotomized at a relative aerobic capacity larger than or equal to 23 O2ml\u00b7kg\u00b7min-1 (1) and (0) otherwise. According to Blair, a relative aerobic capacity below 23 O2ml\u00b7kg\u00b7min-1 is regarded as a high risk value for cardiovascular disease in women [Two outcome variables were used. The first was in women .age was categorized into 3 groups based upon tertiles of the data, 24-39, 40-44, and 45-64 years.Self-reported BMI (kg\u00b7m-2) was calculated from the objectively measured height and weight. BMI is categorized into 3 groups by the WHO  and otherwise as (0).Height was measured to the nearest 0.5 cm using a stadiometer (Seca 214), and weight was measured using a bioimpedance analysis  to the nearest 0.1 kg, subtracting 2.0 kg for clothes.  obesity . In the Educational status was classified into three categories: less than 10 years, 10-12 years, and more than 12 years.Employment status was dichotomized as being employed or unemployed. Unemployed also included those on sick- or parental leave, retirees, students, and housewives.Acculturation was assessed on the basis of language skills. The acculturation variable has been used previously by the Swedish government-owned statistics bureau to study integration and health in a random sample of Swedish immigrants from Chile, Iran, Poland and Turkey.The participants in the present study answered to the following questions concerning: (1) knowledge of how to appeal against authorities, (2) ability to understand news reports, (3) speaking Swedish at meetings, (4) communicating with authorities over the telephone, (5) reading books in Swedish, and (6) being able to complete a written application for employment. The 1st question had two response alternatives (yes or no). The other five questions had four possible response alternatives, with 1 characterizing the highest degree and 4 the lowest degree of knowledge in Swedish. The answers to each question were dichotomized as one point for alternatives 1 and 2 (or 1 for question 1) and with zero points for alternatives 3 and 4 (or 2 for question 1). The dichotomy variables were summed up and categorized at two levels, with a low level of knowledge of Swedish/acculturation if the score was less than 4 and a high level of knowledge of Swedish/acculturation for a score of 4 or more.Years in Sweden was assessed as a continuous variable.n) and percentage (%) for categorical data (Table Baseline characteristics are shown as the median and interquartile range (IQR) for continuous data and number  \u00d7 2 (time: baseline and 6-month follow-up) design, we analysed the treatment effect in relative aerobic capacity by applying a mixed linear model with random intercepts and slopes. Mixed model analyses allowed inclusion of subjects with missing data and differences between groups at baseline . The resWe used a generalized estimating equations (GEE) model (with an exchangeable correlation matrix and robust standard errors) when analysing the dichotomized outcome, fitness level . The resThe statistical package used was STATA Release 10 .2ml\u00b7kg\u00b7min-1) between groups with a power of 90% and a significance level \u03b1 = 0.05 (based upon data from a pilot study with a mean of 24 O2ml\u00b7kg\u00b7min-1 and a standard deviation of 7 and a correlation of 0.7 between occasions), 69 individuals per group were needed. An increase of 3 units for a person with very low aerobic capacity is important from a cardiovascular health perspective [To find a difference of 3 units in \u0394 for relative aerobic capacity .P < 0.05). The control group had a significantly better relative aerobic capacity and a higher percentage with an acceptable fitness level (relative aerobic capacity > 23 O2ml\u00b7kg\u00b7min-1) at baseline than the intervention group.The characteristics of the study population are shown by group in Table relative aerobic capacity as outcome, while educational level, employment status, and acculturation did not. Table P = 0.02). This indicates that there is a treatment effect, i.e. the intervention group improved their relative aerobic capacity significantly more than the control group.We found that age and BMI significantly influenced the mixed model for P = 0.00001) larger increase over the 6-month follow-up in relative aerobic capacity than the control group (P = 0.02). However, the control group had a higher relative aerobic capacity than the intervention group at both baseline (P = 0.0001) and the 6-month follow-up (P = 0.01).The \u03b2-coefficients with 95% confidence intervals are shown in Table P = 0.02), also including age and BMI, when analysing the dichotomized outcome fitness level (relative aerobic capacity > 23 O2ml\u00b7kg\u00b7min-1). Table The GEE model showed results similar to those of the mixed model with a significant interaction between treatment and time (relative aerobic capacity and the percentage with an acceptable fitness level (relative aerobic capacity > 23 O2ml\u00b7kg\u00b7min-1) to a greater extent than the control group from baseline to the 6-month follow-up, after adjustments for age and BMI. However, the control group was on a higher level at both baseline and follow-up, which was taken into consideration by employing a mixed linear model with random intercepts and slopes and, for fitness level, a GEE model.The main finding of this controlled clinical trial was that the intervention group increased their 2max), determined during submaximal exercise testing, has been shown to provide a good estimate of cardiorespiratory capacity, which is an independent marker of the early atherosclerotic cardiovascular diseases [The finding that a combined primary health care- and community-based exercise intervention increased the relative aerobic capacity and the percentage with an acceptable fitness level is important because such an intervention may have the potential to decrease lifestyle-related disease risks such as coronary heart disease, cancer, and diabetes mellitus in low-active refugee women. Cardiorespiratory fitness, which we measured as maximum oxygen consumption  in comparison with standard care in a primary care setting of sedentary ethnic minority and low-income women . Their rA protocol for an ongoing randomized controlled trial in primary health care recently reported on the effectiveness of an exercise referral scheme in the short and long term among women from ethnic minority groups . SeveralOne limitation in the design of the study is the use of a controlled clinical trial instead of a randomized controlled trial (RCT). Conducting a study in a real-life setting that can be implemented in the society at large is difficult. Although an RCT would have been optimal from a study design perspective, bias may be present in an RCT . For exaThis study also has several strengths. One is that it was conducted using existing community institutions, such as primary health care centres, which means that the model can be readily implemented. There are challenges in recruiting minority groups to prevention programmes with the aim to reduce cardiovascular risk factors ,52.A recent systematic review was able to identify only 13 intervention studies among immigrants of which three focused on cardiovascular risk factors . Most ofAnother strength is the use of a group-based intervention to be used in a country with a large and diverse immigrant population, particularly from the Middle Eastern countries. Besides the fact that the women can support one another, it is also cost-effective for the community compared to programmes for individuals or single immigrant groups. Finally, this study was evaluated using an objective measure of fitness, not just the self-reported level of physical activity, which is subject to measuring errors .This controlled clinical trial showed that a combined primary-health-care and community-based exercise programme can constitute an effective strategy to increase fitness among low-active overweight refugee women who are at risk of future coronary heart disease.The authors declare that they have no competing interests.JS, KS and SEJ contributed to the design of the study. All authors contributed to the analysis and interpretation of data. MH drafted the first manuscript. All authors revised the manuscript for important intellectual content and gave their final approval of the version to be submitted.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2296/11/55/prepub", "texts": ["Refugee women have a high risk of coronary heart disease with low physical activity as one possible mediator. Furthermore, cultural and environmental barriers to increasing physical activity have been demonstrated. The aim of the study was to evaluate the combined effect of an approximate 6-month primary health care- and community-based exercise intervention versus an individual written prescription for exercise on objectively assessed cardiorespiratory fitness in low-active refugee women.Relative aerobic capacity and fitness level were assessed as the two main outcome measures.A controlled clinical trial, named \"Support for Increased Physical Activity\", was executed among 243 refugee women recruited between November 2006 and April 2008 from two deprived geographic areas in southern Stockholm, Sweden. One geographic area provided the intervention group and the other area the control group. The control group was on a higher activity level at both baseline and follow-up, which was taken into consideration in the analysis by applying statistical models that accounted for this. relative aerobic capacity and the percentage with an acceptable fitness level (relative aerobic capacity > 23 O2ml\u00b7kg\u00b7min-1) to a greater extent than the control group between baseline and the 6-month follow-up, after adjusting for possible confounders (P = 0.020).The intervention group increased their A combined primary health-care and community-based exercise programme (involving non-profit organizations) can be an effective strategy to increase cardiorespiratory fitness among low-active refugee women.ClinicalTrials.gov ID: NCT00747942 Demographic and economic changes have resulted in a more diverse population with greater social disparities in Sweden during the last few decades because of the large influx of refugees mainly from Latin America in the 1970 s, Iran in the 1980 s, Bosnia and the Balkans in the 1990 s, and Iraq and the Middle East in the 2000 s. Refugee status has previously been defined by the United Nations as a person who is outside the protection of his or hers country owing to a well-founded fear of being persecuted for reasons of race, religion, nationality, membership of a particular social group, or political opinion [New York Times Magazine provided data documenting the growing ethnic minority and socioeconomic segregation in urban and suburban Sweden [The large influx of refugees has changed Swedish society. A 2005 article in the Many of these refugees have an increased risk of coronary heart disease (CHD) in both men and women. Female refugees born in Turkey, Iran, and Iraq and settled in Sweden had an age-adjusted excess risk of CHD compared with Swedish-born controls ranging from 110% to 130% -7. Femal2max below the 50th percentile and were also obese [Although it is convenient to assess changes in physical activity with questionnaires, cardiovascular fitness is a more reliable and objective measure. For example, data from the longitudinal CARDIA study showed that a change in individual cardiorespiratory fitness is strongly associated with a corresponding change in habitual energy expenditure and leisure time physical activity . Furtherso obese .largest increase in physical activity levels can be found among the least active at baseline; minority groups were, however, not included in that study [Physical inactivity and obesity are potential mediators of accelerating arteriosclerosis and the development of CHD seen among refugee women. According to the World Health Organization (WHO), it is important to target these risk factors in order to decrease the global burden of CHD. In addition, previous research has shown that the at study . Therefoat study . The finBoth individual and environmental factors are associated with physical activity in minority women. For example, a qualitative study from the United States showed that a lack of time due to caregiving duties, health worries, and lack of motivation were important barriers to women from ethnic minorities and refugee women becoming more physically active . The womThe real life situation of many refugee women in Sweden, such as low socioeconomic status, low educational status, and residing in a deprived and unsafe neighbourhood, has been associated with low levels of physical activity and exercise . In thisThe purpose of the present study was to investigate whether appropriate physical activities and social support can increase cardiorespiratory fitness in refugee women in Sweden. This purpose was implemented by evaluating the effect of an approximate 6-month primary health-care- and community-based exercise intervention versus an individual written prescription for exercise on objectively assessed cardiorespiratory fitness in low-active and overweight refugee women.St\u00f6d till Aktivare Motion or STAM in Swedish).This controlled clinical trial was named Support for Increased Physical Activity , to identify the two deprived and immigrant-dense geographic areas (including large populations of Middle East refugees). The CNI scores ranged from-76.4 (most affluent neighbourhood) to 53.5 (most deprived neighbourhood) . The CNIEligible for inclusion were women aged 25 through 64 who were first-generation refugees in Sweden from either the Middle East or Latin America, were overweight and reported low levels of physical activity during their leisure time  ,23. We eWe appealed to the community to obtain access to physical activity facilities for the intervention. Nine primary health care centres located in the two immigrant-dense areas were partly used in the recruitment processes. This process included information brochures in the waiting room but the women were also informed about the study by the personnel at the primary health care centres. We also recruited women through local advertising and via community organizations such as women's associations, child welfare centres, pre-schools, churches/mosques and courses in Swedish for immigrants.The women who were willing to participate filled in a first screening protocol. All women who filled in the screening protocol were contacted by research staff who could speak their native language. The participants were further informed about the study and those who agreed to participate and were eligible for inclusion were enrolled for a baseline assessment. Eligible for inclusion included 131 women in the intervention group and 112 women in the control group. All written material  was translated to Spanish or Arabic by two independent professional translators and backwards translated by two other professional translators.2(m) (according to WHO's recommendations) and comprised three categories: (1) normal weight (BMI < 25.0), (2) overweight (BMI 25.0-29.9) and (3) obesity (BMI \u2265 30).In total three questions were included in the screening protocol to assess physical activity, overweight/obesity, and pre-existing ill health. Physical activity was assessed by asking the participants how often they exercise during their leisure-time. The response alternatives were the following: (1) I get practically no exercise at all, (2) I exercise occasionally, (3) I exercise regularly, about once a week, (4) I exercise regularly, about twice a week and (5) I exercise regularly, quite vigorously at least twice a week. Overweight and obesity were assessed on the basis of self-reported data on weight and height. Body mass index (BMI) was calculated as weight(kg)/heightOur intention was to include only those who were inactive  and overweight/obese. However, around 10% in the intervention group and 50% in the control group were found to have a normal weight at the baseline measurements. They were not excluded from the study but we took BMI into account in the analyses.n = 114 women in the intervention group and 98 women in the control group) were assessed at baseline. Most women came from the Middle East: 96% and 80% in the intervention and control group, respectively. The women mainly came from the following countries: Iraq, Syria, Turkey, Lebanon and Chile. The largest groups in the intervention group came from Syria (26%) and Lebanon (10%) and the largest groups in the control group came from Turkey (26%) and Iraq (24%).Background information  was assessed at baseline. Height, weight and cardiorespiratory fitness were assessed at baseline and at 6 months. In total, 212 women  was given during the summer break. The women attended 16 sessions in average (range 1-32). An initial session of individual counselling with the purpose to strengthen self-efficacy, empowerment and personal motivation was given by a female physiotherapist who guided the women concerning how to start doing regular physical activities at a health-enhancing level and informed them about the benefits associated with physical activity. This initial session also addressed possible barriers to physical activity based on findings of a previous qualitative study, e.g. worries about palpitations, tiredness and sweating (15). The women received information about different levels of health-enhancing physical activity, such as moderate and vigorous physical activity and how they are related to perceived exertion . The womThe participants in the control group received an individual written prescription for exercise that was partly based on the results from the cardiorespiratory fitness together with an initial session of individual counselling. In general, the written prescription was based on the recommendation of regular health-enhancing physical activity, i.e. 30 minutes per day at a moderate intensity level ,30. The 2 l\u00b7min-1) were calculated by the bicycle computer, using the \u00c5strand-Rhyming nomogram (24). The data collectors in the present study were not blinded because we recruited the intervention and control groups from two different geographic areas.The \u00c5strand-Rhyming submaximal bicycle ergometer test was used to assess cardiorespiratory fitness . The MonOut of the 212 women who were assessed at baseline, 179 (84%) had at least one measurement either at baseline or at the six-month follow-up and they were included in the analysis (n = 91 in the intervention group and n = 88 in the control group). Most of the 33 excluded women were either not able to perform the test due to poor bicycling skills, or not able to bike at the correct speed, or had inadequate muscular strength to perform the test. A standardized walking test might have been an option; still, we believe that many of the women had too low a capacity to fit within any standardized protocol. The 33 excluded women did not differ with regard to age or BMI from those included.To sum up, 243 women (131 women in the intervention group and 112 women in the control group) showed an initial interest to take part in the study and were considered eligible. Of these women, 212 came to the baseline assessments (114 women in the intervention group and 98 women in the control group) and 179 had at least one measurement either at baseline or at the six-month follow-up (91 women in the intervention group and 88 women in the control group). All women in the intervention group took part in at least one session with a leader/instructor.relative aerobic capacity, defined as oxygen uptake per kilo body weight (O2ml\u00b7kg\u00b7min-1). The second outcome variable, fitness level, was dichotomized at a relative aerobic capacity larger than or equal to 23 O2ml\u00b7kg\u00b7min-1 (1) and (0) otherwise. According to Blair, a relative aerobic capacity below 23 O2ml\u00b7kg\u00b7min-1 is regarded as a high risk value for cardiovascular disease in women [Two outcome variables were used. The first was in women .age was categorized into 3 groups based upon tertiles of the data, 24-39, 40-44, and 45-64 years.Self-reported BMI (kg\u00b7m-2) was calculated from the objectively measured height and weight. BMI is categorized into 3 groups by the WHO  and otherwise as (0).Height was measured to the nearest 0.5 cm using a stadiometer (Seca 214), and weight was measured using a bioimpedance analysis  to the nearest 0.1 kg, subtracting 2.0 kg for clothes.  obesity . In the Educational status was classified into three categories: less than 10 years, 10-12 years, and more than 12 years.Employment status was dichotomized as being employed or unemployed. Unemployed also included those on sick- or parental leave, retirees, students, and housewives.Acculturation was assessed on the basis of language skills. The acculturation variable has been used previously by the Swedish government-owned statistics bureau to study integration and health in a random sample of Swedish immigrants from Chile, Iran, Poland and Turkey.The participants in the present study answered to the following questions concerning: (1) knowledge of how to appeal against authorities, (2) ability to understand news reports, (3) speaking Swedish at meetings, (4) communicating with authorities over the telephone, (5) reading books in Swedish, and (6) being able to complete a written application for employment. The 1st question had two response alternatives (yes or no). The other five questions had four possible response alternatives, with 1 characterizing the highest degree and 4 the lowest degree of knowledge in Swedish. The answers to each question were dichotomized as one point for alternatives 1 and 2 (or 1 for question 1) and with zero points for alternatives 3 and 4 (or 2 for question 1). The dichotomy variables were summed up and categorized at two levels, with a low level of knowledge of Swedish/acculturation if the score was less than 4 and a high level of knowledge of Swedish/acculturation for a score of 4 or more.Years in Sweden was assessed as a continuous variable.n) and percentage (%) for categorical data (Table Baseline characteristics are shown as the median and interquartile range (IQR) for continuous data and number  \u00d7 2 (time: baseline and 6-month follow-up) design, we analysed the treatment effect in relative aerobic capacity by applying a mixed linear model with random intercepts and slopes. Mixed model analyses allowed inclusion of subjects with missing data and differences between groups at baseline . The resWe used a generalized estimating equations (GEE) model (with an exchangeable correlation matrix and robust standard errors) when analysing the dichotomized outcome, fitness level . The resThe statistical package used was STATA Release 10 .2ml\u00b7kg\u00b7min-1) between groups with a power of 90% and a significance level \u03b1 = 0.05 (based upon data from a pilot study with a mean of 24 O2ml\u00b7kg\u00b7min-1 and a standard deviation of 7 and a correlation of 0.7 between occasions), 69 individuals per group were needed. An increase of 3 units for a person with very low aerobic capacity is important from a cardiovascular health perspective [To find a difference of 3 units in \u0394 for relative aerobic capacity .P < 0.05). The control group had a significantly better relative aerobic capacity and a higher percentage with an acceptable fitness level (relative aerobic capacity > 23 O2ml\u00b7kg\u00b7min-1) at baseline than the intervention group.The characteristics of the study population are shown by group in Table relative aerobic capacity as outcome, while educational level, employment status, and acculturation did not. Table P = 0.02). This indicates that there is a treatment effect, i.e. the intervention group improved their relative aerobic capacity significantly more than the control group.We found that age and BMI significantly influenced the mixed model for P = 0.00001) larger increase over the 6-month follow-up in relative aerobic capacity than the control group (P = 0.02). However, the control group had a higher relative aerobic capacity than the intervention group at both baseline (P = 0.0001) and the 6-month follow-up (P = 0.01).The \u03b2-coefficients with 95% confidence intervals are shown in Table P = 0.02), also including age and BMI, when analysing the dichotomized outcome fitness level (relative aerobic capacity > 23 O2ml\u00b7kg\u00b7min-1). Table The GEE model showed results similar to those of the mixed model with a significant interaction between treatment and time (relative aerobic capacity and the percentage with an acceptable fitness level (relative aerobic capacity > 23 O2ml\u00b7kg\u00b7min-1) to a greater extent than the control group from baseline to the 6-month follow-up, after adjustments for age and BMI. However, the control group was on a higher level at both baseline and follow-up, which was taken into consideration by employing a mixed linear model with random intercepts and slopes and, for fitness level, a GEE model.The main finding of this controlled clinical trial was that the intervention group increased their 2max), determined during submaximal exercise testing, has been shown to provide a good estimate of cardiorespiratory capacity, which is an independent marker of the early atherosclerotic cardiovascular diseases [The finding that a combined primary health care- and community-based exercise intervention increased the relative aerobic capacity and the percentage with an acceptable fitness level is important because such an intervention may have the potential to decrease lifestyle-related disease risks such as coronary heart disease, cancer, and diabetes mellitus in low-active refugee women. Cardiorespiratory fitness, which we measured as maximum oxygen consumption  in comparison with standard care in a primary care setting of sedentary ethnic minority and low-income women . Their rA protocol for an ongoing randomized controlled trial in primary health care recently reported on the effectiveness of an exercise referral scheme in the short and long term among women from ethnic minority groups . SeveralOne limitation in the design of the study is the use of a controlled clinical trial instead of a randomized controlled trial (RCT). Conducting a study in a real-life setting that can be implemented in the society at large is difficult. Although an RCT would have been optimal from a study design perspective, bias may be present in an RCT . For exaThis study also has several strengths. One is that it was conducted using existing community institutions, such as primary health care centres, which means that the model can be readily implemented. There are challenges in recruiting minority groups to prevention programmes with the aim to reduce cardiovascular risk factors ,52.A recent systematic review was able to identify only 13 intervention studies among immigrants of which three focused on cardiovascular risk factors . Most ofAnother strength is the use of a group-based intervention to be used in a country with a large and diverse immigrant population, particularly from the Middle Eastern countries. Besides the fact that the women can support one another, it is also cost-effective for the community compared to programmes for individuals or single immigrant groups. Finally, this study was evaluated using an objective measure of fitness, not just the self-reported level of physical activity, which is subject to measuring errors .This controlled clinical trial showed that a combined primary-health-care and community-based exercise programme can constitute an effective strategy to increase fitness among low-active overweight refugee women who are at risk of future coronary heart disease.The authors declare that they have no competing interests.JS, KS and SEJ contributed to the design of the study. All authors contributed to the analysis and interpretation of data. MH drafted the first manuscript. All authors revised the manuscript for important intellectual content and gave their final approval of the version to be submitted.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2296/11/55/prepub"]}
{"representative": "Physicians are often unable to eat and drink properly during their work day. Nutrition has been linked to cognition. We aimed to examine the effect of a nutrition based intervention, that of scheduled nutrition breaks during the work day, upon physician cognition, glucose, and hypoglycemic symptoms.A volunteer sample of twenty staff physicians from a large urban teaching hospital were recruited from the doctors' lounge. During both the baseline and the intervention day, we measured subjects' cognitive function, capillary blood glucose, \"hypoglycemic\" nutrition-related symptoms, fluid and nutrient intake, level of physical activity, weight, and urinary output.Cognition scores as measured by a composite score of speed and accuracy (Tput statistic) were superior on the intervention day on simple  and complex  reaction time tests. Group mean glucose was 0.3 mmol/L lower (p = 0.03) and less variable (coefficient of variation 12.2% vs. 18.0%) on the intervention day. Although not statistically significant, there was also a trend toward the reporting of fewer hypoglycemic type symptoms. There was higher nutrient intake on intervention versus baseline days as measured by mean caloric intake , and improved hydration as measured by mean change in body mass .Our study provides evidence in support of adequate workplace nutrition as a contributor to improved physician cognition, adding to the body of research suggesting that physician wellness may ultimately benefit not only the physicians themselves but also their patients and the health care systems in which they work. The typical work day of a hospital based physician is not only cognitively demanding, requiring complex decision-making in a fast-paced environment, it is also physically demanding, with extended hours and frequent on call periods. During their work time, physicians may be far removed from areas that provide access to nutrition (fluids and nutrients). As a result, physicians are often unable to eat and drink properly or at all during their work day -4.Previous studies have demonstrated that the impairment of neurological functions such as fine motor skills, information processing, and memory, is linked to hypoglycemia and under-nutrition and may contribute to motor vehicle collisions and air crashes -9. ConvePhysician performance has been increasingly linked to lifestyle and wellness factors such as sleep deprivation and stress and, in turn, to the quality of patient care -18. HoweTwenty consecutive staff physician volunteers were recruited from the doctors' lounge of a large urban teaching hospital during the first week of May 2008 following a hospital wide poster campaign advertising study recruitment location and timing. The physicians selected two typical, similar work days to be scheduled as the baseline and intervention study periods during May and/or June 2008. All data were collected on site at the hospital. Ethics approval was obtained from the Conjoint Ethics Review Board of the University of Calgary. Written consent was obtained from participants.This prospective study compared physicians' nutritional intake and cognitive function during work hours on two separate work days, a baseline day and an intervention day. A before and after study design was chosen rather than assigning participants to intervention or control days in random order, given the possibility that physicians assigned to first receive the intervention may be influenced to alter their typical nutritional habits. On the baseline day, the physicians followed their usual eating and drinking habits. On the intervention day, they were fed nutritious meals, snacks and fluids at scheduled intervals. Participants chose two typical and similar work days  within a two week period to serve as baseline and intervention days. Most physicians chose daytime work hours as the study period (17/20) while three chose evening and overnight work hours.The intervention, that of ensuring that physicians consumed nutrients and fluids at regular intervals throughout their work day, was designed based on previous research where physicians and other health care professionals described barriers to achieving adequate nutritional intake during work hours -4, unpub, unpub4,The primary outcome was cognition. Secondary outcomes were blood glucose levels and \"hypoglycemic\" nutrition-related symptoms. Baseline demographic characteristics were recorded at study enrolment. Fluid and nutrient intake and physical activity were measured on both days. At the beginning of each day, participants were weighed and fitted with an activity and heart rate monitor. At that time and at approximately two hour intervals on both days, measures of cognitive function, capillary blood glucose, \"hypoglycemic\" nutrition-related symptoms, food and fluid intake, and volume of urine excreted over the previous two hours were captured. Participants were weighed again at the end of each day. On the baseline day, the physicians maintained their usual eating and drinking habits. On the intervention day, the physicians reported to the study center fasting, and all nutrition for the day was delivered to the physician and recorded. The participants were blinded to their glucose and cognitive function test results at the time of testing.Cognition was measured using Brain Checkers software, Version 3.01  run on Palm Tungsten E2, . Two software programs were used. The simple reaction test was designed to measure the speed of motor response to a visual cue with repeated testing over thirty seconds. The complex reaction test, a choice reaction time and continuous performance task, was designed to measure running memory, attention and visual information processing with repeated testing over two minutes. This task requires the subject to indicate whether the current number (1 through 9 appearing randomly on a screen) matches the previously displayed number (with random time delay between the two) by tapping on the appropriate text box (labelled \"same\" or \"different\") located below the number. For both tests, the reaction times of each unique response as well as the mean reaction time for the session were recorded for each participant. Accuracy was documented in terms of percent correct responses, lapses (the subject did not respond to the stimulus) and impulses (the subject anticipated and acted before the prompt). A Tput statistic was calculated that captures the correct responses per minute of time available to respond. It represents a combination of speed and accuracy with a higher Tput statistic indicating a superior performance. Based on the manufacturer's recommendation, subjects completed three practice tests prior to baseline data collection. This approach eliminates any learning effect during the study period and prevents learning effects from confounding actual study measurements -22.Capillary blood glucose samples were collected from participants' fingertip and analyzed immediately using the Precision Xtra Blood Glucose Monitoring System (glucose measured in millimoles per liter). Participants were asked to report from a checklist of \"hypoglycemic\" nutrition-related symptoms, including those produced by falling glucose and counterregulatory hormones and by reduced brain glucose. The seventeen symptoms covered manifestations of adrenergic responses , glucagon responses , and neuroglycopenic responses  ,24. The Body mass was measured using SR Model SR241 scales . The measure of weight, performed by either of the two research assistants at the beginning and end of each study period, was standardized by using a single digital scale at the same location and ensuring participants' equivalent post urinary void state and clothing status . Volume of fluid consumed and urine voided were quantified. Dietary analyses were performed using individual physicians' recorded diet history . Two-hour diet recall was also taken at each blood glucose sampling in order to enhance the validity of the dietary record. Only nutritional intake during the study period was analyzed using Diet Analysis+, Canadian version 4.0 . Nutritional requirements were based upon the Dietary Reference Intakes (DRI 2002) , which rA triaxial accelerometer that records acceleration in three planes  recorded activity level and heart rate simultaneously every fifteen seconds. Physicians were asked to rate both days on scales of 0 (low) to 10 (high) for workload, stress and general well being.After determining the appropriateness of parametric analytical methods, the statistical significance of mean differences in blood glucose levels and cognitive test scores were calculated using a generalized estimating equation to take into account the repeated measurements taken during each study day; change in body mass, and fluid and nutrient intake on baseline and intervention days were assessed for normalcy and means were compared using paired two sided t-tests; where the assumption of normalcy was not met, results were presented as medians plus interquartile range, and compared using a Wilcoxon signed rank test. Variability in glucose values was calculated using the coefficient of variation (CV), which describes variability relative to the mean [CV = (standard deviation/mean)*100%]. Analysis of variance (ANOVA) was used to assess within-day differences in mean cognitive test scores across the sampling times. A Fisher's exact test was used to compare proportion of physicians reporting \"hypoglycemic\" nutrition-related symptoms on baseline and intervention days.This study was originally conceived as a pilot study for preliminary testing of a nutrition based intervention, and for determination of multiple physiological and nutritional measurements in twenty working physicians. Given this, there were no a priori sample size considerations. However, based on mean glucose and cognition (Tput) values obtained, and corresponding standard deviations, we determined post-hoc that we had 96% power to detect a difference of 0.28 mmol/L in glucose values, and 97% power to detect a difference of 5 in Tput scores from the complex cognition test for the intervention day versus the baseline day.All statistical analyses were performed using Stata 10 .2 and ranged from 20.3 to 38.3 kg/m2. All participants were non-smokers and 15/20 (75%) reported exercising at moderate or high intensity for 30 minutes or longer at least 2-4 days per week. All twenty subjects completed both days with full data and follow-up for all study measures. No adverse effects of the intervention were reported.Twenty physicians from various medical specialties participated, with 10/20 participants (50%) from a medical specialty , 8/20 (40%) from a surgical specialty , and the remaining two (10%) from a primary care specialty . The mean duration of medical practice was 16.5 years, ranging from 5 to 36 years. The mean age was 46.8 years, and ranged from 36 to 64 years, and 85% were male. The mean Body Mass Index was 25.5 kg/mGroup mean glucose was slightly lower and considerably less variable on the intervention day compared to the baseline day Figure . The groStudy participants often reported symptoms associated with \"hypoglycemia\" despite few glucose results in the hypoglycemic range. On the baseline day, the symptoms most commonly reported were hunger (15/20 participants), fatigue (9/20), sweating (6/20), sensation of warmth (6/20), and drowsiness (5/20). On the intervention day, the symptoms most commonly reported were hunger (12/20), fatigue (7/20), sweating (3/20), sensation of warmth (3/20), or inability to concentrate (3/20). Supplementary analysis of the number of individual symptoms reported by each participant was also undertaken. Although the results were not statistically significant (p = 0.36), there was a trend toward fewer symptoms during the intervention day relative to the baseline day  participants showed a mean loss of body mass on the baseline day compared with a mean gain during the intervention day . Mean fluid intake was significantly greater on the intervention day  . The group mean average heart rate  and physical workload  were also similar. Physicians' self reports on a scale of 0 (low) to 10 (high) comparing the baseline to the intervention day showed no difference for perceived workload , stress , or general well being .The scheduled healthy food and fluids consumed during the intervention day were associated with improved physician cognition and less glucose variability. Although not statistically significant, there was also a trend toward the reporting of fewer hypoglycemic type symptoms. The change in cognitive function associated with the intervention appears notable relative to both population norms and age-related differences. For the simple reaction time test, the expected normal performance for ages 34-49 is a Tput score of 207, and a mean reaction time of 294 msec, and for ages 50-59, scores of 197 and 309 msec respectively. For the complex reaction time test, the expected normal performance for ages 34-49 is a Tput score of 100, and a mean reaction time of 547 msec and for ages 50-59, scores of 80 and 618 msec respectively . Our stuThe intervention was well received by participating physicians and its success may have been due to a number of factors. Nutrition was enforced through a scheduled regimen of food and fluid intake, readily available either at the centrally located doctors' lounge or at the physician's practice location. Physicians have previously indicated that they are often too busy to stop and eat and that limited access to nutrition during the work day, due to factors such as location, hours of operation, and cafeteria line ups, is a significant barrier . They haOn a practical level, implementing a nutritional intervention in a health care system is feasible. Health care organizations are increasingly evaluating the quality of food and drink made available to patients and staff, recognizing the benefits of quality nutrition to overall health. Making time for nutrition can be encouraged by developing educational campaigns that promote the benefits of nutrition breaks, by carefully scheduling nutrition opportunities during work hours, and through peer support of nutrition as a necessary component of a physician's ability to deliver quality health care. While food and drink are already available at defined locations in most hospitals, improved access can be achieved through placement of nutrition stations in high workload areas. For example, healthy food stations may be set up near operating rooms and on acute care wards via mobile carts, or where physicians tend to gather most, such as in the doctors' lounge. Although the nutritional intervention in this study was cost free, qualitative interview data from the study participants (results available from authors) support that physicians are willing to pay for good quality food and drink, suggesting that most of these proposals would be cost neutral. Lastly, there may be a number of secondary benefits to health care systems that are staffed by physicians who are cognitively improved as a result of adequate nutrition.As noted above, the literature provides evidence of the negative consequences of suboptimal nutrition for workers in a variety of work settings, in particular as they relate to cognitive function. Studies have also shown an association between the personal dietary habits of physicians and medical students and their nutrition counseling behaviors and attitudes ,29. FurtThe main limitation of this study is the relatively small number of participants. However, our paired study design and richness of measures nonetheless permitted sufficient statistical power to detect several significant differences on key measures between the two study days. A second limitation is the predominantly male and hospital based physician study sample, with a potential lack of sampling across the different types of workdays physicians may experience. For further generalization of results, these variables, and others such as age and weight would also need to be taken into account in future research. A third potential limitation is the non-randomized study design. However, the study is not necessarily weakened by lack of randomization between the intervention and non-intervention control groups given we ensured comparability in our pair wise comparison within individuals. A fourth limitation is that the study was not designed to evaluate whether the differences found between the study days translate into improved patient care. Lastly, the manufacturers of the cognitive function tests cite research to support that the learner effect is attenuated after three practice trials. Although it is still possible that a learner effect influenced the study results, each participant did undergo three practice trials before starting the study, and the ANOVA analyses across sampling times within each study day did not suggest a learner effect for same days responses. Weighing against these limitations is the strength of the full participation of twenty physicians over both study days despite interruptions in their work day due to the extensive collection of physiological measures and the added time commitments.Future studies might consider the development and randomized evaluation of an intervention that is more feasible in the acute care setting and that is based on a sustainable business model . Our study provides evidence in support of adequate workplace nutrition as a contributor to improved physician cognition, adding to the body of research suggesting that physician wellness may ultimately benefit not only the physicians themselves but also their patients and the health care systems in which they work .The authors declare that they have no competing interests.All authors had access to the data, had a role in writing the manuscript, and approved the final manuscript. JL contributed to the study conception and design, acquisition of data, analysis and interpretation of data, drafting and critical revision of the manuscript, statistical analysis, obtaining funding, and administrative support. JW contributed to the study conception and design, analysis and interpretation of data, critical revision of the manuscript, statistical analysis, obtaining funding. KD contributed to the study design, acquisition of data, analysis and interpretation of data, critical revision of the manuscript and technical support. WG contributed to the analysis and interpretation of the data, critical revision of the manuscript, statistical analysis, and administrative and material support. AL contributed to statistical analysis and interpretation of data, drafting of the manuscript and critical revision of the manuscript. DR contributed to the conception and design of the study, acquisition of data, analysis and interpretation of data, critical revision of the manuscript, statistical analysis, and technical and material support. JL had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis, and had final responsibility for the decision to submit the manuscript for publication.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1472-6963/10/241/prepub", "texts": ["Physicians are often unable to eat and drink properly during their work day. Nutrition has been linked to cognition. We aimed to examine the effect of a nutrition based intervention, that of scheduled nutrition breaks during the work day, upon physician cognition, glucose, and hypoglycemic symptoms.A volunteer sample of twenty staff physicians from a large urban teaching hospital were recruited from the doctors' lounge. During both the baseline and the intervention day, we measured subjects' cognitive function, capillary blood glucose, \"hypoglycemic\" nutrition-related symptoms, fluid and nutrient intake, level of physical activity, weight, and urinary output.Cognition scores as measured by a composite score of speed and accuracy (Tput statistic) were superior on the intervention day on simple  and complex  reaction time tests. Group mean glucose was 0.3 mmol/L lower (p = 0.03) and less variable (coefficient of variation 12.2% vs. 18.0%) on the intervention day. Although not statistically significant, there was also a trend toward the reporting of fewer hypoglycemic type symptoms. There was higher nutrient intake on intervention versus baseline days as measured by mean caloric intake , and improved hydration as measured by mean change in body mass .Our study provides evidence in support of adequate workplace nutrition as a contributor to improved physician cognition, adding to the body of research suggesting that physician wellness may ultimately benefit not only the physicians themselves but also their patients and the health care systems in which they work. The typical work day of a hospital based physician is not only cognitively demanding, requiring complex decision-making in a fast-paced environment, it is also physically demanding, with extended hours and frequent on call periods. During their work time, physicians may be far removed from areas that provide access to nutrition (fluids and nutrients). As a result, physicians are often unable to eat and drink properly or at all during their work day -4.Previous studies have demonstrated that the impairment of neurological functions such as fine motor skills, information processing, and memory, is linked to hypoglycemia and under-nutrition and may contribute to motor vehicle collisions and air crashes -9. ConvePhysician performance has been increasingly linked to lifestyle and wellness factors such as sleep deprivation and stress and, in turn, to the quality of patient care -18. HoweTwenty consecutive staff physician volunteers were recruited from the doctors' lounge of a large urban teaching hospital during the first week of May 2008 following a hospital wide poster campaign advertising study recruitment location and timing. The physicians selected two typical, similar work days to be scheduled as the baseline and intervention study periods during May and/or June 2008. All data were collected on site at the hospital. Ethics approval was obtained from the Conjoint Ethics Review Board of the University of Calgary. Written consent was obtained from participants.This prospective study compared physicians' nutritional intake and cognitive function during work hours on two separate work days, a baseline day and an intervention day. A before and after study design was chosen rather than assigning participants to intervention or control days in random order, given the possibility that physicians assigned to first receive the intervention may be influenced to alter their typical nutritional habits. On the baseline day, the physicians followed their usual eating and drinking habits. On the intervention day, they were fed nutritious meals, snacks and fluids at scheduled intervals. Participants chose two typical and similar work days  within a two week period to serve as baseline and intervention days. Most physicians chose daytime work hours as the study period (17/20) while three chose evening and overnight work hours.The intervention, that of ensuring that physicians consumed nutrients and fluids at regular intervals throughout their work day, was designed based on previous research where physicians and other health care professionals described barriers to achieving adequate nutritional intake during work hours -4, unpub, unpub4,The primary outcome was cognition. Secondary outcomes were blood glucose levels and \"hypoglycemic\" nutrition-related symptoms. Baseline demographic characteristics were recorded at study enrolment. Fluid and nutrient intake and physical activity were measured on both days. At the beginning of each day, participants were weighed and fitted with an activity and heart rate monitor. At that time and at approximately two hour intervals on both days, measures of cognitive function, capillary blood glucose, \"hypoglycemic\" nutrition-related symptoms, food and fluid intake, and volume of urine excreted over the previous two hours were captured. Participants were weighed again at the end of each day. On the baseline day, the physicians maintained their usual eating and drinking habits. On the intervention day, the physicians reported to the study center fasting, and all nutrition for the day was delivered to the physician and recorded. The participants were blinded to their glucose and cognitive function test results at the time of testing.Cognition was measured using Brain Checkers software, Version 3.01  run on Palm Tungsten E2, . Two software programs were used. The simple reaction test was designed to measure the speed of motor response to a visual cue with repeated testing over thirty seconds. The complex reaction test, a choice reaction time and continuous performance task, was designed to measure running memory, attention and visual information processing with repeated testing over two minutes. This task requires the subject to indicate whether the current number (1 through 9 appearing randomly on a screen) matches the previously displayed number (with random time delay between the two) by tapping on the appropriate text box (labelled \"same\" or \"different\") located below the number. For both tests, the reaction times of each unique response as well as the mean reaction time for the session were recorded for each participant. Accuracy was documented in terms of percent correct responses, lapses (the subject did not respond to the stimulus) and impulses (the subject anticipated and acted before the prompt). A Tput statistic was calculated that captures the correct responses per minute of time available to respond. It represents a combination of speed and accuracy with a higher Tput statistic indicating a superior performance. Based on the manufacturer's recommendation, subjects completed three practice tests prior to baseline data collection. This approach eliminates any learning effect during the study period and prevents learning effects from confounding actual study measurements -22.Capillary blood glucose samples were collected from participants' fingertip and analyzed immediately using the Precision Xtra Blood Glucose Monitoring System (glucose measured in millimoles per liter). Participants were asked to report from a checklist of \"hypoglycemic\" nutrition-related symptoms, including those produced by falling glucose and counterregulatory hormones and by reduced brain glucose. The seventeen symptoms covered manifestations of adrenergic responses , glucagon responses , and neuroglycopenic responses  ,24. The Body mass was measured using SR Model SR241 scales . The measure of weight, performed by either of the two research assistants at the beginning and end of each study period, was standardized by using a single digital scale at the same location and ensuring participants' equivalent post urinary void state and clothing status . Volume of fluid consumed and urine voided were quantified. Dietary analyses were performed using individual physicians' recorded diet history . Two-hour diet recall was also taken at each blood glucose sampling in order to enhance the validity of the dietary record. Only nutritional intake during the study period was analyzed using Diet Analysis+, Canadian version 4.0 . Nutritional requirements were based upon the Dietary Reference Intakes (DRI 2002) , which rA triaxial accelerometer that records acceleration in three planes  recorded activity level and heart rate simultaneously every fifteen seconds. Physicians were asked to rate both days on scales of 0 (low) to 10 (high) for workload, stress and general well being.After determining the appropriateness of parametric analytical methods, the statistical significance of mean differences in blood glucose levels and cognitive test scores were calculated using a generalized estimating equation to take into account the repeated measurements taken during each study day; change in body mass, and fluid and nutrient intake on baseline and intervention days were assessed for normalcy and means were compared using paired two sided t-tests; where the assumption of normalcy was not met, results were presented as medians plus interquartile range, and compared using a Wilcoxon signed rank test. Variability in glucose values was calculated using the coefficient of variation (CV), which describes variability relative to the mean [CV = (standard deviation/mean)*100%]. Analysis of variance (ANOVA) was used to assess within-day differences in mean cognitive test scores across the sampling times. A Fisher's exact test was used to compare proportion of physicians reporting \"hypoglycemic\" nutrition-related symptoms on baseline and intervention days.This study was originally conceived as a pilot study for preliminary testing of a nutrition based intervention, and for determination of multiple physiological and nutritional measurements in twenty working physicians. Given this, there were no a priori sample size considerations. However, based on mean glucose and cognition (Tput) values obtained, and corresponding standard deviations, we determined post-hoc that we had 96% power to detect a difference of 0.28 mmol/L in glucose values, and 97% power to detect a difference of 5 in Tput scores from the complex cognition test for the intervention day versus the baseline day.All statistical analyses were performed using Stata 10 .2 and ranged from 20.3 to 38.3 kg/m2. All participants were non-smokers and 15/20 (75%) reported exercising at moderate or high intensity for 30 minutes or longer at least 2-4 days per week. All twenty subjects completed both days with full data and follow-up for all study measures. No adverse effects of the intervention were reported.Twenty physicians from various medical specialties participated, with 10/20 participants (50%) from a medical specialty , 8/20 (40%) from a surgical specialty , and the remaining two (10%) from a primary care specialty . The mean duration of medical practice was 16.5 years, ranging from 5 to 36 years. The mean age was 46.8 years, and ranged from 36 to 64 years, and 85% were male. The mean Body Mass Index was 25.5 kg/mGroup mean glucose was slightly lower and considerably less variable on the intervention day compared to the baseline day Figure . The groStudy participants often reported symptoms associated with \"hypoglycemia\" despite few glucose results in the hypoglycemic range. On the baseline day, the symptoms most commonly reported were hunger (15/20 participants), fatigue (9/20), sweating (6/20), sensation of warmth (6/20), and drowsiness (5/20). On the intervention day, the symptoms most commonly reported were hunger (12/20), fatigue (7/20), sweating (3/20), sensation of warmth (3/20), or inability to concentrate (3/20). Supplementary analysis of the number of individual symptoms reported by each participant was also undertaken. Although the results were not statistically significant (p = 0.36), there was a trend toward fewer symptoms during the intervention day relative to the baseline day  participants showed a mean loss of body mass on the baseline day compared with a mean gain during the intervention day . Mean fluid intake was significantly greater on the intervention day  . The group mean average heart rate  and physical workload  were also similar. Physicians' self reports on a scale of 0 (low) to 10 (high) comparing the baseline to the intervention day showed no difference for perceived workload , stress , or general well being .The scheduled healthy food and fluids consumed during the intervention day were associated with improved physician cognition and less glucose variability. Although not statistically significant, there was also a trend toward the reporting of fewer hypoglycemic type symptoms. The change in cognitive function associated with the intervention appears notable relative to both population norms and age-related differences. For the simple reaction time test, the expected normal performance for ages 34-49 is a Tput score of 207, and a mean reaction time of 294 msec, and for ages 50-59, scores of 197 and 309 msec respectively. For the complex reaction time test, the expected normal performance for ages 34-49 is a Tput score of 100, and a mean reaction time of 547 msec and for ages 50-59, scores of 80 and 618 msec respectively . Our stuThe intervention was well received by participating physicians and its success may have been due to a number of factors. Nutrition was enforced through a scheduled regimen of food and fluid intake, readily available either at the centrally located doctors' lounge or at the physician's practice location. Physicians have previously indicated that they are often too busy to stop and eat and that limited access to nutrition during the work day, due to factors such as location, hours of operation, and cafeteria line ups, is a significant barrier . They haOn a practical level, implementing a nutritional intervention in a health care system is feasible. Health care organizations are increasingly evaluating the quality of food and drink made available to patients and staff, recognizing the benefits of quality nutrition to overall health. Making time for nutrition can be encouraged by developing educational campaigns that promote the benefits of nutrition breaks, by carefully scheduling nutrition opportunities during work hours, and through peer support of nutrition as a necessary component of a physician's ability to deliver quality health care. While food and drink are already available at defined locations in most hospitals, improved access can be achieved through placement of nutrition stations in high workload areas. For example, healthy food stations may be set up near operating rooms and on acute care wards via mobile carts, or where physicians tend to gather most, such as in the doctors' lounge. Although the nutritional intervention in this study was cost free, qualitative interview data from the study participants (results available from authors) support that physicians are willing to pay for good quality food and drink, suggesting that most of these proposals would be cost neutral. Lastly, there may be a number of secondary benefits to health care systems that are staffed by physicians who are cognitively improved as a result of adequate nutrition.As noted above, the literature provides evidence of the negative consequences of suboptimal nutrition for workers in a variety of work settings, in particular as they relate to cognitive function. Studies have also shown an association between the personal dietary habits of physicians and medical students and their nutrition counseling behaviors and attitudes ,29. FurtThe main limitation of this study is the relatively small number of participants. However, our paired study design and richness of measures nonetheless permitted sufficient statistical power to detect several significant differences on key measures between the two study days. A second limitation is the predominantly male and hospital based physician study sample, with a potential lack of sampling across the different types of workdays physicians may experience. For further generalization of results, these variables, and others such as age and weight would also need to be taken into account in future research. A third potential limitation is the non-randomized study design. However, the study is not necessarily weakened by lack of randomization between the intervention and non-intervention control groups given we ensured comparability in our pair wise comparison within individuals. A fourth limitation is that the study was not designed to evaluate whether the differences found between the study days translate into improved patient care. Lastly, the manufacturers of the cognitive function tests cite research to support that the learner effect is attenuated after three practice trials. Although it is still possible that a learner effect influenced the study results, each participant did undergo three practice trials before starting the study, and the ANOVA analyses across sampling times within each study day did not suggest a learner effect for same days responses. Weighing against these limitations is the strength of the full participation of twenty physicians over both study days despite interruptions in their work day due to the extensive collection of physiological measures and the added time commitments.Future studies might consider the development and randomized evaluation of an intervention that is more feasible in the acute care setting and that is based on a sustainable business model . Our study provides evidence in support of adequate workplace nutrition as a contributor to improved physician cognition, adding to the body of research suggesting that physician wellness may ultimately benefit not only the physicians themselves but also their patients and the health care systems in which they work .The authors declare that they have no competing interests.All authors had access to the data, had a role in writing the manuscript, and approved the final manuscript. JL contributed to the study conception and design, acquisition of data, analysis and interpretation of data, drafting and critical revision of the manuscript, statistical analysis, obtaining funding, and administrative support. JW contributed to the study conception and design, analysis and interpretation of data, critical revision of the manuscript, statistical analysis, obtaining funding. KD contributed to the study design, acquisition of data, analysis and interpretation of data, critical revision of the manuscript and technical support. WG contributed to the analysis and interpretation of the data, critical revision of the manuscript, statistical analysis, and administrative and material support. AL contributed to statistical analysis and interpretation of data, drafting of the manuscript and critical revision of the manuscript. DR contributed to the conception and design of the study, acquisition of data, analysis and interpretation of data, critical revision of the manuscript, statistical analysis, and technical and material support. JL had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis, and had final responsibility for the decision to submit the manuscript for publication.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1472-6963/10/241/prepub"]}
{"representative": "Objective To determine whether integration of nutritional supplementation with other public health programmes in early life reduces the risk of cardiovascular disease in undernourished populations.Design Approximately 15 years\u2019 follow-up of participants born within an earlier controlled, community trial of nutritional supplementation integrated with other public health programmes.Setting 29 villages  near Hyderabad city, south India.Participants 1165 adolescents aged 13-18 years.Intervention Balanced protein-calorie supplementation  offered daily to pregnant women and preschool children aged under 6 years, coupled with integrated delivery of vertical public health programmes.Main outcome measures Height, adiposity, blood pressures, lipids, insulin resistance (homoeostasis model assessment (HOMA) score), and arterial stiffness (augmentation index).Results The participants from the intervention villages were 14 mm  taller than controls but had similar body composition. The participants from the intervention villages had more favourable measures of insulin resistance and arterial stiffness: 20%  lower HOMA score and 3.3%  lower augmentation index. No strong evidence existed for differences in blood pressures and serum lipids.Conclusions In this undernourished population, integrated delivery of supplemental nutrition with other public health programmes in pregnancy and early childhood was associated with a more favourable profile of cardiovascular disease risk factors in adolescence. This pragmatic study provides the most robust evidence to date on this important hypothesis for which classic trials are unlikely. Improved maternal and child nutrition may have a role in reducing the burden of cardiovascular disease in low income and middle income countries. Some authors have suggested that the risk of cardiovascular diseases can be \u201cprogrammed\u201d in early life through the persistence of endocrine, physiological, and metabolic adaptations made in the face of undernutrition.3The evidence in support of this hypothesis is largely circumstantial: animal experiments and observational studies in humans showing associations between anthropometric measures (as proxies for undernutrition) and risk of cardiovascular disease.10Integrated Child Development Services is a national community based programme aimed at improving the health, nutrition, and development of children in India.13Using the opportunity afforded by the stepwise expansion of this programme during the 1980s and 1990s, the National Institute of Nutrition in India ran a trial to assess (among other things) the impact of food supplementation in pregnancy on the birth weight of offspring. A cluster of villages with a total population of 30\u2009000 was chosen from each of the two adjacent administrative areas , one of which already had the Integrated Child Development Services programme in place (intervention arm), whereas the other was awaiting implementation (control arm). As the 100 or more villages in each of the two blocks were spread over an unfeasibly large area, villages were chosen geographically for random selection: contiguous villages falling within a 10 km radius of a prominent central village  in each block were selected. This process resulted in 15 villages from the intervention arm and 14 villages from the control arm being recruited to the study.A 12 member team of investigators resided full time in the field for the duration of the study. Following a lead-in period of six months , the trial included all births in the area between 1 January 1987 and 31 December 1990. The \u201cat risk\u201d (of pregnancy) women were monitored monthly to detect missing of menstruation, and those identified as pregnant were followed closely during pregnancy until delivery . The field team attempted to visit the home as soon as possible after delivery to collect data on the outcome of the pregnancy and to weigh the newborn within 48 hours. An infant beam balance with a 20 g accuracy  was used to measure weight.The supplement given in this trial was \u201cupma,\u201d a local preparation made from corn-soya blend (120 g) and soybean oil (16 g), providing 2.51 MJ and 20 g protein to the women and half this amount to the children. No other nutrients  were added to the supplement. The other universal programmes\u2014immunisation, anaemia control in pregnancy through distribution of iron  and folic acid (500 \u03bcg) tablets, and the provision of basic health care\u2014existed to a similar extent in both the intervention and control areas, although their uptake may be presumed to have been higher in the intervention area. Crossover of supplements from intervention to control villages was not a problem because of their separation by a large number of villages not involved in the study; in addition, supplements were offered only to the named residents of the village. A preliminary abstract reported the ongoing study,We designed this follow-up study to establish the status of women and their offspring who took part in the trial and to clinically examine offspring who were still resident in the area. The parents and children gave written informed consent.We did two parallel surveys on a village to village basis\u2014the first to identify the study participants and the second to do clinical examinations. The identification survey preceded the clinical survey by three months, and we interchanged the survey area between intervention and control villages every couple of months to even out any variations arising from seasons and experience of the study team. In the identification survey, we first identified women who took part in the baseline trial by using their own and their husband\u2019s name. We interviewed each woman thus identified to collect details on children she had previously borne. All children born in these villages during the initial trial period (1987-90) were potential study participants. However, owing to limited resources and to make maximal use of the baseline data, we invited only those children who could be successfully matched to the previous records to have clinical examinations. We used date of birth and sex for matching, as infants\u2019 names were not recorded in the baseline study . Where multiple children of the same woman were eligible, we invited them all and made appropriate adjustments in the analyses.We used a single clinic site at each village  to reduce measurement error arising from differences in clinic conditions. We held clinics in the morning, and invited 10-15 children to come fasting each day. We completed a full interviewer administered questionnaire and clinical examination on the children and a brief questionnaire on the mothers (who were asked to accompany the child).We measured height with a portable stadiometer . The participant stood erect with his or her head in the Frankfort plane, and a gentle upward pressure was applied under the mastoid. We used a digital weighing machine  to measure weight. We measured skinfold thickness at four sites  in triplicate with the Holtain calliper . We used a validated oscillometric device  to measure blood pressure in the supine position with appropriate cuff sizes; we took two measurements and averaged them for analyses. We measured ambient room temperature with a digital thermometer.We assessed the augmentation index, a measure of global arterial stiffness, by using an applanation tonometry technique with the Sphygmocor apparatus  Medical, Sydney, Australia).We classified sexual maturation into four stages  on the basis of time since the onset of menstruation (girls) and testicular volume (boys).We collected fasting blood samples (at least eight hours) in appropriate vacutainers, transferred them within one to two hours (in icebox at 4-8\u00b0 C), and processed them within four hours. We did assays for glucose, triglycerides, total cholesterol, and high density lipoprotein cholesterol on the same day with an autoanalyser  and the recommended kits . We estimated insulin concentrations by radioimmunoassay in batches within four to six weeks.18We produced detailed protocols and used them regularly to standardise the work of the fieldwork team. \u201cBlinding\u201d of the fieldworkers to the group assignment was not an option; however, all measurements except anthropometry were to a large extent automated , thus reducing the possibility of bias. Only one observer made each measurement , to eliminate interobserver bias. We assessed reproducibility of clinic measurements by repeating the measurements on a random subsample (5%) of participants after one to three weeks and found it to be consistently high (intraclass correlation coefficients of >0.98 for anthropometric measures and >0.85 for blood pressures and augmentation index). We put in place internal and external quality control arrangements  for biochemical assays, and split assays were done on a 5% subsample (intraclass correlation coefficients >0.94). We validated testicular self assessment technique against a trained observer in a separate substudy and found it to be highly accurate (mean difference in model ranks (self reported minus directly observed)\u20140.07 \u2014with no evidence of systematic bias on a Bland-Altman plot).We used the log of the sum of four skinfolds to calculate the percentage of body fat23We applied suitable transformations to outcome variables that deviated markedly from a normal distribution . We used linear regression models to investigate association of supplemental nutrition with cardiovascular disease risk factors. Analysis was on an intention to treat basis, using area of birth as proxy (irrespective of whether the participant took the supplement or not). We fitted four predefined models to adjust incrementally for the main domains of potential confounding or intermediary variables: model 1 ; model 2 ; model 3 (stature\u2014height); and model 4 . We additionally adjusted blood pressure for ambient room temperature and augmentation index for heart rate, as these factors can artefactually affect their values.26Data could be clustered at the level of the village and the household (in case of multiple children). To take account of village level clustering, we used robust standard errors in all the models, with village as the level of cluster. This technique uses the cluster level residuals to derive the standard errors, so that the resulting standard errors are larger and valid in the presence of clustering but the parameter estimate remains unchanged. This technique was inappropriate for household level clustering, as very few households had multiple children taking part in the study. We therefore examined the impact of household level clustering on the results by excluding the second of the two children from the same household (no household contained more than two children). We similarly estimated the impact of a few migrant children  on the results by excluding these children from the final models. We examined interaction between the intervention and the sex of the participant, as evidence exists of preferential feeding of male children in this setting,Sample size calculations done before the start of the study suggested that the anticipated sample  was going to be adequate to detect important differences in most outcomes .Of the 4338 pregnancies recorded in the trial, birth weights (recorded within 48 hours) were available for 2964 (68%) children. The mean birth weight of children born in the intervention area (2655 (SD 424) g) was higher than that of controls (2594 (SD 430) g); the mean difference was 61 g . Adjustment for sex of the child made no difference to the results; however, we deemed data on gestational age to be of insufficient quality (strong digit preference) to be included in the analyses. Personal information (necessary to trace families) was available for 2756 women, of which 1963 (71%) could be contacted successfully  children for at least one outcome, with slightly fewer for blood pressure , lipid profile , glucose-insulin , and arterial stiffness . The lower number with glucose-insulin data was due to a failure to obtain insulin assay reagent in time for the last batch of assays (n=48), and that for arterial stiffness data was due to an inability to complete all assessments during the course of a clinic day, as most villages lacked the continuous electricity supply needed to run the apparatus. Some, but not all, of the participants returned subsequently to have their assessments completed.Table 2Children in the intervention and control arms were not different in their sexual maturation (data not shown). Table 4The study included 36 sibling pairs, of which five pairs were twins; all other households contributed only one child to the study. Thirty two participants had migrated away from their place of birth, of which nine had migrated within the study area . Exclusion of the migrant children or the second child (in the case of sibling pairs) made no material difference to the results.This is the first intervention study to show that modest improvements in the protein-calorie intake of pregnant women and young children may result in a more favourable cardiovascular disease risk factor profile among populations with prevalent undernutrition. These findings may indicate potential life course pathways underlying the causes of cardiovascular diseases in general.The importance of balanced protein-calorie malnutrition in early life has been studied in two natural experiments based on the starvation experience of populations under siege in the second world war (Dutch and Leningrad studies) and one small randomised controlled trial of supplemental nutrition from Guatemala.The main strength of this study is its setting: a nutritional intervention in a population with high background levels of chronic undernutrition, so we could realistically expect to find programming effects of inadequate diet, if they exist. The controlled design of the original evaluation would have reduced the chances of confounding; furthermore, the crucial confounders were either completely absent  or severely restricted .The study also has some important limitations that need to be acknowledged, chief among them the potential for bias owing to non-randomisation of villages in the baseline study, losses to follow-up, and lack of data on current diet and patterns of physical activity. In the baseline study, all villages within a radius of the central village were selected in both intervention and control areas, making selection bias unlikely. Bias could arise, however, if the intervention area urbanised at a different rate from the control area, thus influencing the prevalence of risk factors for cardiovascular disease. Data on urbanisation  collected from the village heads showed little variation between the villages (data not shown), and adjustment for urbanisation (population size) did not materially alter any of the results. Areas considered deprived are prioritised for the introduction of the Integrated Child Development Services programme in phases; however, the staggered introduction of the programme in similarly deprived and adjacent areas (such as those in the study) is mainly due to financial and operational constraints associated with the introduction of a public programme in a large country .12The response rate among children invited to the clinic was high 78%), although it was somewhat lower in the control areas, which in all probability arose from lack of interest in participation in the study shown by heads of some of the control villages . Loss to follow-up resulting from this is likely to be non-systematic. The participating children represented 45% of all eligible births in the area from that time, which compares favourably with the overall follow-up rates in other relevant studies .8%, althoDifferences in current diet and patterns of physical activity could account for the differences seen in risk of cardiovascular disease. Although it is theoretically possible, we see no obvious reason to believe that children from these neighbouring villages had marked differences in lifestyle. The villages are still fairly homogeneous in their diet (limited range of foods eaten mostly at home) and activity patterns . Furthermore, no differences in body composition existed; as adiposity reflects the net energy balance between intake (diet) and expenditure , the low fat mass in this population and its narrow distribution range, argues against any important lifestyle differences between the two areas. Finally, despite the relative automation of most of the outcome measures used in this study , the possibility of bias arising from the lack of blinding of the fieldworkers cannot be ruled out completely.Insulin resistance is believed to be central to many of the changes attributed to the thrifty phenotype.42The relative importance of nutrition in various stages , sources of nutrition, or indeed the rate of growth in early versus late postnatal life cannot be delineated from this study, as the intervention was given throughout.45We need to contextualise our observations and consider what public health benefits may accrue if this intervention was translated into primary prevention of disease burden. The Anglo-Cardiff collaborative study suggested that a 3% lower augmentation index equates to a three year less aged vascular phenotype.34The intervention in this study was given within the framework of a public welfare programme.Observational studies suggest that early undernutrition predisposes to cardiovascular disease in later life, but robust evidence from intervention trials is lackingIntegration of supplemental nutrition with public health programmes in pregnancy and early childhood was associated with a reduction in cardiovascular riskImproved maternal and child nutrition may have a role in reducing the burden of cardiovascular disease in low income and middle income countries", "texts": ["Objective To determine whether integration of nutritional supplementation with other public health programmes in early life reduces the risk of cardiovascular disease in undernourished populations.Design Approximately 15 years\u2019 follow-up of participants born within an earlier controlled, community trial of nutritional supplementation integrated with other public health programmes.Setting 29 villages  near Hyderabad city, south India.Participants 1165 adolescents aged 13-18 years.Intervention Balanced protein-calorie supplementation  offered daily to pregnant women and preschool children aged under 6 years, coupled with integrated delivery of vertical public health programmes.Main outcome measures Height, adiposity, blood pressures, lipids, insulin resistance (homoeostasis model assessment (HOMA) score), and arterial stiffness (augmentation index).Results The participants from the intervention villages were 14 mm  taller than controls but had similar body composition. The participants from the intervention villages had more favourable measures of insulin resistance and arterial stiffness: 20%  lower HOMA score and 3.3%  lower augmentation index. No strong evidence existed for differences in blood pressures and serum lipids.Conclusions In this undernourished population, integrated delivery of supplemental nutrition with other public health programmes in pregnancy and early childhood was associated with a more favourable profile of cardiovascular disease risk factors in adolescence. This pragmatic study provides the most robust evidence to date on this important hypothesis for which classic trials are unlikely. Improved maternal and child nutrition may have a role in reducing the burden of cardiovascular disease in low income and middle income countries. Some authors have suggested that the risk of cardiovascular diseases can be \u201cprogrammed\u201d in early life through the persistence of endocrine, physiological, and metabolic adaptations made in the face of undernutrition.3The evidence in support of this hypothesis is largely circumstantial: animal experiments and observational studies in humans showing associations between anthropometric measures (as proxies for undernutrition) and risk of cardiovascular disease.10Integrated Child Development Services is a national community based programme aimed at improving the health, nutrition, and development of children in India.13Using the opportunity afforded by the stepwise expansion of this programme during the 1980s and 1990s, the National Institute of Nutrition in India ran a trial to assess (among other things) the impact of food supplementation in pregnancy on the birth weight of offspring. A cluster of villages with a total population of 30\u2009000 was chosen from each of the two adjacent administrative areas , one of which already had the Integrated Child Development Services programme in place (intervention arm), whereas the other was awaiting implementation (control arm). As the 100 or more villages in each of the two blocks were spread over an unfeasibly large area, villages were chosen geographically for random selection: contiguous villages falling within a 10 km radius of a prominent central village  in each block were selected. This process resulted in 15 villages from the intervention arm and 14 villages from the control arm being recruited to the study.A 12 member team of investigators resided full time in the field for the duration of the study. Following a lead-in period of six months , the trial included all births in the area between 1 January 1987 and 31 December 1990. The \u201cat risk\u201d (of pregnancy) women were monitored monthly to detect missing of menstruation, and those identified as pregnant were followed closely during pregnancy until delivery . The field team attempted to visit the home as soon as possible after delivery to collect data on the outcome of the pregnancy and to weigh the newborn within 48 hours. An infant beam balance with a 20 g accuracy  was used to measure weight.The supplement given in this trial was \u201cupma,\u201d a local preparation made from corn-soya blend (120 g) and soybean oil (16 g), providing 2.51 MJ and 20 g protein to the women and half this amount to the children. No other nutrients  were added to the supplement. The other universal programmes\u2014immunisation, anaemia control in pregnancy through distribution of iron  and folic acid (500 \u03bcg) tablets, and the provision of basic health care\u2014existed to a similar extent in both the intervention and control areas, although their uptake may be presumed to have been higher in the intervention area. Crossover of supplements from intervention to control villages was not a problem because of their separation by a large number of villages not involved in the study; in addition, supplements were offered only to the named residents of the village. A preliminary abstract reported the ongoing study,We designed this follow-up study to establish the status of women and their offspring who took part in the trial and to clinically examine offspring who were still resident in the area. The parents and children gave written informed consent.We did two parallel surveys on a village to village basis\u2014the first to identify the study participants and the second to do clinical examinations. The identification survey preceded the clinical survey by three months, and we interchanged the survey area between intervention and control villages every couple of months to even out any variations arising from seasons and experience of the study team. In the identification survey, we first identified women who took part in the baseline trial by using their own and their husband\u2019s name. We interviewed each woman thus identified to collect details on children she had previously borne. All children born in these villages during the initial trial period (1987-90) were potential study participants. However, owing to limited resources and to make maximal use of the baseline data, we invited only those children who could be successfully matched to the previous records to have clinical examinations. We used date of birth and sex for matching, as infants\u2019 names were not recorded in the baseline study . Where multiple children of the same woman were eligible, we invited them all and made appropriate adjustments in the analyses.We used a single clinic site at each village  to reduce measurement error arising from differences in clinic conditions. We held clinics in the morning, and invited 10-15 children to come fasting each day. We completed a full interviewer administered questionnaire and clinical examination on the children and a brief questionnaire on the mothers (who were asked to accompany the child).We measured height with a portable stadiometer . The participant stood erect with his or her head in the Frankfort plane, and a gentle upward pressure was applied under the mastoid. We used a digital weighing machine  to measure weight. We measured skinfold thickness at four sites  in triplicate with the Holtain calliper . We used a validated oscillometric device  to measure blood pressure in the supine position with appropriate cuff sizes; we took two measurements and averaged them for analyses. We measured ambient room temperature with a digital thermometer.We assessed the augmentation index, a measure of global arterial stiffness, by using an applanation tonometry technique with the Sphygmocor apparatus  Medical, Sydney, Australia).We classified sexual maturation into four stages  on the basis of time since the onset of menstruation (girls) and testicular volume (boys).We collected fasting blood samples (at least eight hours) in appropriate vacutainers, transferred them within one to two hours (in icebox at 4-8\u00b0 C), and processed them within four hours. We did assays for glucose, triglycerides, total cholesterol, and high density lipoprotein cholesterol on the same day with an autoanalyser  and the recommended kits . We estimated insulin concentrations by radioimmunoassay in batches within four to six weeks.18We produced detailed protocols and used them regularly to standardise the work of the fieldwork team. \u201cBlinding\u201d of the fieldworkers to the group assignment was not an option; however, all measurements except anthropometry were to a large extent automated , thus reducing the possibility of bias. Only one observer made each measurement , to eliminate interobserver bias. We assessed reproducibility of clinic measurements by repeating the measurements on a random subsample (5%) of participants after one to three weeks and found it to be consistently high (intraclass correlation coefficients of >0.98 for anthropometric measures and >0.85 for blood pressures and augmentation index). We put in place internal and external quality control arrangements  for biochemical assays, and split assays were done on a 5% subsample (intraclass correlation coefficients >0.94). We validated testicular self assessment technique against a trained observer in a separate substudy and found it to be highly accurate (mean difference in model ranks (self reported minus directly observed)\u20140.07 \u2014with no evidence of systematic bias on a Bland-Altman plot).We used the log of the sum of four skinfolds to calculate the percentage of body fat23We applied suitable transformations to outcome variables that deviated markedly from a normal distribution . We used linear regression models to investigate association of supplemental nutrition with cardiovascular disease risk factors. Analysis was on an intention to treat basis, using area of birth as proxy (irrespective of whether the participant took the supplement or not). We fitted four predefined models to adjust incrementally for the main domains of potential confounding or intermediary variables: model 1 ; model 2 ; model 3 (stature\u2014height); and model 4 . We additionally adjusted blood pressure for ambient room temperature and augmentation index for heart rate, as these factors can artefactually affect their values.26Data could be clustered at the level of the village and the household (in case of multiple children). To take account of village level clustering, we used robust standard errors in all the models, with village as the level of cluster. This technique uses the cluster level residuals to derive the standard errors, so that the resulting standard errors are larger and valid in the presence of clustering but the parameter estimate remains unchanged. This technique was inappropriate for household level clustering, as very few households had multiple children taking part in the study. We therefore examined the impact of household level clustering on the results by excluding the second of the two children from the same household (no household contained more than two children). We similarly estimated the impact of a few migrant children  on the results by excluding these children from the final models. We examined interaction between the intervention and the sex of the participant, as evidence exists of preferential feeding of male children in this setting,Sample size calculations done before the start of the study suggested that the anticipated sample  was going to be adequate to detect important differences in most outcomes .Of the 4338 pregnancies recorded in the trial, birth weights (recorded within 48 hours) were available for 2964 (68%) children. The mean birth weight of children born in the intervention area (2655 (SD 424) g) was higher than that of controls (2594 (SD 430) g); the mean difference was 61 g . Adjustment for sex of the child made no difference to the results; however, we deemed data on gestational age to be of insufficient quality (strong digit preference) to be included in the analyses. Personal information (necessary to trace families) was available for 2756 women, of which 1963 (71%) could be contacted successfully  children for at least one outcome, with slightly fewer for blood pressure , lipid profile , glucose-insulin , and arterial stiffness . The lower number with glucose-insulin data was due to a failure to obtain insulin assay reagent in time for the last batch of assays (n=48), and that for arterial stiffness data was due to an inability to complete all assessments during the course of a clinic day, as most villages lacked the continuous electricity supply needed to run the apparatus. Some, but not all, of the participants returned subsequently to have their assessments completed.Table 2Children in the intervention and control arms were not different in their sexual maturation (data not shown). Table 4The study included 36 sibling pairs, of which five pairs were twins; all other households contributed only one child to the study. Thirty two participants had migrated away from their place of birth, of which nine had migrated within the study area . Exclusion of the migrant children or the second child (in the case of sibling pairs) made no material difference to the results.This is the first intervention study to show that modest improvements in the protein-calorie intake of pregnant women and young children may result in a more favourable cardiovascular disease risk factor profile among populations with prevalent undernutrition. These findings may indicate potential life course pathways underlying the causes of cardiovascular diseases in general.The importance of balanced protein-calorie malnutrition in early life has been studied in two natural experiments based on the starvation experience of populations under siege in the second world war (Dutch and Leningrad studies) and one small randomised controlled trial of supplemental nutrition from Guatemala.The main strength of this study is its setting: a nutritional intervention in a population with high background levels of chronic undernutrition, so we could realistically expect to find programming effects of inadequate diet, if they exist. The controlled design of the original evaluation would have reduced the chances of confounding; furthermore, the crucial confounders were either completely absent  or severely restricted .The study also has some important limitations that need to be acknowledged, chief among them the potential for bias owing to non-randomisation of villages in the baseline study, losses to follow-up, and lack of data on current diet and patterns of physical activity. In the baseline study, all villages within a radius of the central village were selected in both intervention and control areas, making selection bias unlikely. Bias could arise, however, if the intervention area urbanised at a different rate from the control area, thus influencing the prevalence of risk factors for cardiovascular disease. Data on urbanisation  collected from the village heads showed little variation between the villages (data not shown), and adjustment for urbanisation (population size) did not materially alter any of the results. Areas considered deprived are prioritised for the introduction of the Integrated Child Development Services programme in phases; however, the staggered introduction of the programme in similarly deprived and adjacent areas (such as those in the study) is mainly due to financial and operational constraints associated with the introduction of a public programme in a large country .12The response rate among children invited to the clinic was high 78%), although it was somewhat lower in the control areas, which in all probability arose from lack of interest in participation in the study shown by heads of some of the control villages . Loss to follow-up resulting from this is likely to be non-systematic. The participating children represented 45% of all eligible births in the area from that time, which compares favourably with the overall follow-up rates in other relevant studies .8%, althoDifferences in current diet and patterns of physical activity could account for the differences seen in risk of cardiovascular disease. Although it is theoretically possible, we see no obvious reason to believe that children from these neighbouring villages had marked differences in lifestyle. The villages are still fairly homogeneous in their diet (limited range of foods eaten mostly at home) and activity patterns . Furthermore, no differences in body composition existed; as adiposity reflects the net energy balance between intake (diet) and expenditure , the low fat mass in this population and its narrow distribution range, argues against any important lifestyle differences between the two areas. Finally, despite the relative automation of most of the outcome measures used in this study , the possibility of bias arising from the lack of blinding of the fieldworkers cannot be ruled out completely.Insulin resistance is believed to be central to many of the changes attributed to the thrifty phenotype.42The relative importance of nutrition in various stages , sources of nutrition, or indeed the rate of growth in early versus late postnatal life cannot be delineated from this study, as the intervention was given throughout.45We need to contextualise our observations and consider what public health benefits may accrue if this intervention was translated into primary prevention of disease burden. The Anglo-Cardiff collaborative study suggested that a 3% lower augmentation index equates to a three year less aged vascular phenotype.34The intervention in this study was given within the framework of a public welfare programme.Observational studies suggest that early undernutrition predisposes to cardiovascular disease in later life, but robust evidence from intervention trials is lackingIntegration of supplemental nutrition with public health programmes in pregnancy and early childhood was associated with a reduction in cardiovascular riskImproved maternal and child nutrition may have a role in reducing the burden of cardiovascular disease in low income and middle income countries"]}
{"representative": "Ingestion of glucosinolates has previously been reported to improve endothelial function in spontaneously hypertensive rats, possibly because of an increase in NO availability in the endothelium due to an attenuation of oxidative stress; in our study we tried to see if this also would be the case in humans suffering from essential hypertension.in vitro antioxidative potential, for a 4 week period or to continue their ordinary diet and act as controls. Blood pressure, endothelial function measured by flow mediated dilation (FMD) and blood samples were obtained from the participants every other week and the content of glucosinolates was measured before and after the study. Measurements were blinded to treatment allocation.40 hypertensive individuals without diabetes and with normal levels of cholesterol were examined. The participants were randomized either to ingest 10 g dried broccoli sprouts, a natural donor of glucosinolates with high In the interventional group overall FMD increased from 4% to 5.8% in the interventional group whereas in the control group FMD was stable (4% at baseline and 3.9% at the end of the study). The change in FMD in the interventional group was mainly due to a marked change in FMD in two participants while the other participants did not have marked changes in FMD. The observed differences were not statistically significant. Likewise significant changes in blood pressure or blood samples were not detected between or within groups. Diastolic blood pressure stayed essentially unchanged in both groups, while the systolic blood pressure showed a small non significant decrease (9 mm Hg) in the interventional group from a value of 153 mm Hg at start.Daily ingestion of 10 g dried broccoli sprouts does not improve endothelial function in the presence of hypertension in humans.NCT00252018Clinicaltrials.gov  Oxidative stress is considered to play a important role in the processes of cellular injury which ultimately leads to the development of atherosclerosis.A group of substances which might have this effect are the glucosinolates, substances naturally occurring in cruciferous plants; the glucosinolates are precursors to isothiocyanates, of which sulphoraphane is one of the most potent inducers of the expression of phase-2-enzymes, in mammalian cells.Among the enzymes induced in vitro the gluthation-S-reductase may be of particular interest since it is instrumental in recycling gluthathion to its reduced state in the cell. In broccoli sprouts younger than 4 days glucoraphaninWe therefore decided to study whether the administration of dried broccoli sprouts in patients with essential hypertension could decrease blood pressure and increase flow mediated vasodilation(FMD). We have focused on endothelial function since this parameter previously has been demonstrated to be influenced by the level of oxidative stress, and because it is a sensitive predictor for oxidative stress as well as for the future development of atherosclerosis.We hypothesized that an increase in flow mediated vasodilation shooud be detectable in the interventonal group after four weeks of treatment both if we used the participants as their own controls and if we compared them to a control group. This was our primary outcome.Secondary outcomes in our study were measurement of blood pressure and lipoproteins where we were interested in seeing if the blood pressure would decrease during treatment and if lipoproteins would show an increase in HDL as well as a decrease in LDL.The protocol for this trial and supporting CONSORT checklist are available as supporting information; see Volunteers were enrolled in the study after advertising in local newspapers for non smoking hypertensive individuals without known diabetes or hypercholesterolemia. In- and Exclusion criteria are listed in The study was approved of the ethics committee for Copenhagen and Frederiksberg municipalities (no 01-257/04). Written informed consent was obtained from all participants.Endothelial function was measured on each individual three times, at start of treatment and twice during the four weeks of treatment with an interval of two weeks. Blood samples for erythrocyte content and inflammation, samples for lipids, blood glucose and inflammation were taken at each visit. Furthermore samples were obtained for analyzing the blood content of glucosinolates and their metabolites. The purpose for measuring the erythrocyte content blood glucose and inflammatory status was to insure that the stimulus for measuring FMD was as uniform as possible for each visit since a change in blood viscosity could influence the shear stress of the vessel wall and therefore increase the measured FMD, likewise elevated blood glucose has been showed to decrease FMD response. Endothelial function was measured using Flow Mediated Dilation (FMD) using a protocol following current guidelines.The broccoli sprouts were obtained from a commercial grower  and were sprouted for 3 days. Immediately after harvesting they were refrigerated and subsequently dried at 40\u00b0C.The dried sprouts were afterwards packaged in airtight plastic bags each containing 10 grams of dried sprouts, equivalent to 100 g fresh sprouts. The dried sprouts had the glucosinolate content measured using previously described methodsPatients were randomised to treatment with broccoli sprouts or control in a 1\u22361 ratio. Treatment consisted in a daily ingestion of 10 g dried broccoli sprouts. The block size for randomization was 4. Randomization was performed by an assistant in sealed envelopes and group allocation was blinded to the investigator. The participants were thus unblinded with regards to their allocation but the investigator was blinded throughout the study to the status of the participants. Since broccoli sprouts are not commercially available and have a much larger content of glucoraphanin than mature broccoli, we were confident that the control group would not ingest glucoraphanin in substantial amounts during the study. Pre-study antihypertensive medications were maintained during the study for all participants. The participants were given a package containing 28 bags with 10 g dried broccoli sprouts in each, instructions were to eat the content with one of the meals of the day, they were also instructed to avoid eating or drinking for at least 8 hours prior to each day of study. As part of our efforts to determine compliance we took blood samples from the participants at each session and the participants were informed that this also was done in order to estimate the content of the active substances in their blood stream. The investigator was blinded during the study and the preliminary statistical analys, During the study the analysis of blood samples and measurement of FMD was done immediately after each session and the data were entered into the study database. The investigator was unaware of the allocation of the participants during the study. After conclusion of the study the allocation of each participant into two groups was given the investigator, but during this part it was still not revealed which group had been the control and which had been the interventional group.Following the hypothesis outlined in the introduction our primary outcome was if we would observe an increase in FMD in the interventional group during the intervention.Secondary outcomes were changes in blood pressure and changes in levels of blood cholesterol during the study in the interventional group.The results were analyzed using SAS software (version 9.10). Comparisons between intervention and control group were analysed by non-paired Student's t-test and comparison of changes over time for the intervention and the control group were performed using a paired students test. Results were presented with calculated mean values and confidence intervals for the measurements at the different session as well as for the differences between values in the two groups.It was assumed that a detectable effect would produce at least a 3% difference in FMD, on this assumption it was calculated that our study would have a power of 90% with 20 individuals in each group.The study enrolled 41 participants, 20 in the control group and 21 in the interventional group. In all 53 persons were screened prior to enrollment, of these10 did not meet the enrollment criteria and 2 decided not to participate. The reason for including one more in the interventional group was that one participant dropped out one day after receiving the sprouts owing to the disagreeable taste of the sprouts. One participant in the interventional group missed one visit because of hospitalization (leg fracture). All other participants received treatment as allocated and participated in examinations as planned. The baseline characteristics for the participants are listed in The FMD values with 95% confidence interval and p values calculated using students test for the intervention and control group are displayed in For the blood test taken simultaneously with the FMD measurements, we have not been able to detect any differences in these samples in the course of our study. The results for are shown in Systolic, diastolic as well as mean blood pressure did not change significantly during the study. Differences detected in the study were related to gender and age.Results are shown in The glucosinolate content of the sprouts was determined before and after the drying and packaging had taken place in order to ensure that the content of glucosinolates in the dried sprouts was known and to asses the possible deterioration of the glucosinolates due to the drying.Measurements of the concentration in the sprouts at the end of the study were similar to those prior to the study . The sprAs stated in the Apart from one participant leaving the study because of the taste of the sprouts which made her very uncomfortable, no adverse effects were observed during the study.In the current study we have tested whether dietary glucosinolates can improve endothelial function in patients with hypertension as it has been demonstrated in animal models.During this period, we have not been able to demonstrate any change in blood pressure, or blood samples reflecting blood lipids or inflammatory status. This finding is at odds with experiments carried out on spontaneously hypertensive stroke prone rats (SHSP), which may be due to a variety of factors. The animal study was designed to investigate if a daily dose of sprouts would protect against the development of hypertension, while we only studied endothelial function in patients with established hypertension. Furthermore, dosage as well as duration of treatment was also different, as the rats were given dried sprouts from weaning and until termination of the experiment after fourteen weeks, which translated to a human lifespan would imply treatment form early childhood into adolescence. Finally, hypertension is not a well described disease entity in humans whereas the SHSP are a distinct breed of rats characterized by their tendency to develop hypertension and stroke.Our study has some limitations that need to be addressed. The dose we gave was, if related to body mass, approximately 7 times smaller than the dosage given to the rats in the study discussed aboveThe fact that we were not able to detect glucosinolates in the blood of the participants raises the question if lack of compliance could be a reason for the lack of observed effect. Other studies does indicate that the glucosinolates in the precense of myrosinase will be transformed to isothocyanates at an early stage of digestionAs stated in the result section we did not find any changes in blood lipids measured during the intervention period. This is at odds with other experiments carried out in humans and with similar doses of sprouts, since Murashima et al demonstrated a decrease in total and LDL cholesterol in humans after one week of treatment with 50 g of fresh broccoli sprouts given daily, our daily dose had twice the glucosinolate content, comparable to 100 g fresh sprouts. We used dried broccoli sprouts as opposed to fresh sprouts, since other studies have shown a rather fast deterioration of the glucosinolate content in fresh broccoliChecklist S1CONSORT Checklist.(0.19 MB DOC)Click here for additional data file.Protocol S1Trial Protocol, in Danish.(0.10 MB DOC)Click here for additional data file.", "texts": ["Ingestion of glucosinolates has previously been reported to improve endothelial function in spontaneously hypertensive rats, possibly because of an increase in NO availability in the endothelium due to an attenuation of oxidative stress; in our study we tried to see if this also would be the case in humans suffering from essential hypertension.in vitro antioxidative potential, for a 4 week period or to continue their ordinary diet and act as controls. Blood pressure, endothelial function measured by flow mediated dilation (FMD) and blood samples were obtained from the participants every other week and the content of glucosinolates was measured before and after the study. Measurements were blinded to treatment allocation.40 hypertensive individuals without diabetes and with normal levels of cholesterol were examined. The participants were randomized either to ingest 10 g dried broccoli sprouts, a natural donor of glucosinolates with high In the interventional group overall FMD increased from 4% to 5.8% in the interventional group whereas in the control group FMD was stable (4% at baseline and 3.9% at the end of the study). The change in FMD in the interventional group was mainly due to a marked change in FMD in two participants while the other participants did not have marked changes in FMD. The observed differences were not statistically significant. Likewise significant changes in blood pressure or blood samples were not detected between or within groups. Diastolic blood pressure stayed essentially unchanged in both groups, while the systolic blood pressure showed a small non significant decrease (9 mm Hg) in the interventional group from a value of 153 mm Hg at start.Daily ingestion of 10 g dried broccoli sprouts does not improve endothelial function in the presence of hypertension in humans.NCT00252018Clinicaltrials.gov  Oxidative stress is considered to play a important role in the processes of cellular injury which ultimately leads to the development of atherosclerosis.A group of substances which might have this effect are the glucosinolates, substances naturally occurring in cruciferous plants; the glucosinolates are precursors to isothiocyanates, of which sulphoraphane is one of the most potent inducers of the expression of phase-2-enzymes, in mammalian cells.Among the enzymes induced in vitro the gluthation-S-reductase may be of particular interest since it is instrumental in recycling gluthathion to its reduced state in the cell. In broccoli sprouts younger than 4 days glucoraphaninWe therefore decided to study whether the administration of dried broccoli sprouts in patients with essential hypertension could decrease blood pressure and increase flow mediated vasodilation(FMD). We have focused on endothelial function since this parameter previously has been demonstrated to be influenced by the level of oxidative stress, and because it is a sensitive predictor for oxidative stress as well as for the future development of atherosclerosis.We hypothesized that an increase in flow mediated vasodilation shooud be detectable in the interventonal group after four weeks of treatment both if we used the participants as their own controls and if we compared them to a control group. This was our primary outcome.Secondary outcomes in our study were measurement of blood pressure and lipoproteins where we were interested in seeing if the blood pressure would decrease during treatment and if lipoproteins would show an increase in HDL as well as a decrease in LDL.The protocol for this trial and supporting CONSORT checklist are available as supporting information; see Volunteers were enrolled in the study after advertising in local newspapers for non smoking hypertensive individuals without known diabetes or hypercholesterolemia. In- and Exclusion criteria are listed in The study was approved of the ethics committee for Copenhagen and Frederiksberg municipalities (no 01-257/04). Written informed consent was obtained from all participants.Endothelial function was measured on each individual three times, at start of treatment and twice during the four weeks of treatment with an interval of two weeks. Blood samples for erythrocyte content and inflammation, samples for lipids, blood glucose and inflammation were taken at each visit. Furthermore samples were obtained for analyzing the blood content of glucosinolates and their metabolites. The purpose for measuring the erythrocyte content blood glucose and inflammatory status was to insure that the stimulus for measuring FMD was as uniform as possible for each visit since a change in blood viscosity could influence the shear stress of the vessel wall and therefore increase the measured FMD, likewise elevated blood glucose has been showed to decrease FMD response. Endothelial function was measured using Flow Mediated Dilation (FMD) using a protocol following current guidelines.The broccoli sprouts were obtained from a commercial grower  and were sprouted for 3 days. Immediately after harvesting they were refrigerated and subsequently dried at 40\u00b0C.The dried sprouts were afterwards packaged in airtight plastic bags each containing 10 grams of dried sprouts, equivalent to 100 g fresh sprouts. The dried sprouts had the glucosinolate content measured using previously described methodsPatients were randomised to treatment with broccoli sprouts or control in a 1\u22361 ratio. Treatment consisted in a daily ingestion of 10 g dried broccoli sprouts. The block size for randomization was 4. Randomization was performed by an assistant in sealed envelopes and group allocation was blinded to the investigator. The participants were thus unblinded with regards to their allocation but the investigator was blinded throughout the study to the status of the participants. Since broccoli sprouts are not commercially available and have a much larger content of glucoraphanin than mature broccoli, we were confident that the control group would not ingest glucoraphanin in substantial amounts during the study. Pre-study antihypertensive medications were maintained during the study for all participants. The participants were given a package containing 28 bags with 10 g dried broccoli sprouts in each, instructions were to eat the content with one of the meals of the day, they were also instructed to avoid eating or drinking for at least 8 hours prior to each day of study. As part of our efforts to determine compliance we took blood samples from the participants at each session and the participants were informed that this also was done in order to estimate the content of the active substances in their blood stream. The investigator was blinded during the study and the preliminary statistical analys, During the study the analysis of blood samples and measurement of FMD was done immediately after each session and the data were entered into the study database. The investigator was unaware of the allocation of the participants during the study. After conclusion of the study the allocation of each participant into two groups was given the investigator, but during this part it was still not revealed which group had been the control and which had been the interventional group.Following the hypothesis outlined in the introduction our primary outcome was if we would observe an increase in FMD in the interventional group during the intervention.Secondary outcomes were changes in blood pressure and changes in levels of blood cholesterol during the study in the interventional group.The results were analyzed using SAS software (version 9.10). Comparisons between intervention and control group were analysed by non-paired Student's t-test and comparison of changes over time for the intervention and the control group were performed using a paired students test. Results were presented with calculated mean values and confidence intervals for the measurements at the different session as well as for the differences between values in the two groups.It was assumed that a detectable effect would produce at least a 3% difference in FMD, on this assumption it was calculated that our study would have a power of 90% with 20 individuals in each group.The study enrolled 41 participants, 20 in the control group and 21 in the interventional group. In all 53 persons were screened prior to enrollment, of these10 did not meet the enrollment criteria and 2 decided not to participate. The reason for including one more in the interventional group was that one participant dropped out one day after receiving the sprouts owing to the disagreeable taste of the sprouts. One participant in the interventional group missed one visit because of hospitalization (leg fracture). All other participants received treatment as allocated and participated in examinations as planned. The baseline characteristics for the participants are listed in The FMD values with 95% confidence interval and p values calculated using students test for the intervention and control group are displayed in For the blood test taken simultaneously with the FMD measurements, we have not been able to detect any differences in these samples in the course of our study. The results for are shown in Systolic, diastolic as well as mean blood pressure did not change significantly during the study. Differences detected in the study were related to gender and age.Results are shown in The glucosinolate content of the sprouts was determined before and after the drying and packaging had taken place in order to ensure that the content of glucosinolates in the dried sprouts was known and to asses the possible deterioration of the glucosinolates due to the drying.Measurements of the concentration in the sprouts at the end of the study were similar to those prior to the study . The sprAs stated in the Apart from one participant leaving the study because of the taste of the sprouts which made her very uncomfortable, no adverse effects were observed during the study.In the current study we have tested whether dietary glucosinolates can improve endothelial function in patients with hypertension as it has been demonstrated in animal models.During this period, we have not been able to demonstrate any change in blood pressure, or blood samples reflecting blood lipids or inflammatory status. This finding is at odds with experiments carried out on spontaneously hypertensive stroke prone rats (SHSP), which may be due to a variety of factors. The animal study was designed to investigate if a daily dose of sprouts would protect against the development of hypertension, while we only studied endothelial function in patients with established hypertension. Furthermore, dosage as well as duration of treatment was also different, as the rats were given dried sprouts from weaning and until termination of the experiment after fourteen weeks, which translated to a human lifespan would imply treatment form early childhood into adolescence. Finally, hypertension is not a well described disease entity in humans whereas the SHSP are a distinct breed of rats characterized by their tendency to develop hypertension and stroke.Our study has some limitations that need to be addressed. The dose we gave was, if related to body mass, approximately 7 times smaller than the dosage given to the rats in the study discussed aboveThe fact that we were not able to detect glucosinolates in the blood of the participants raises the question if lack of compliance could be a reason for the lack of observed effect. Other studies does indicate that the glucosinolates in the precense of myrosinase will be transformed to isothocyanates at an early stage of digestionAs stated in the result section we did not find any changes in blood lipids measured during the intervention period. This is at odds with other experiments carried out in humans and with similar doses of sprouts, since Murashima et al demonstrated a decrease in total and LDL cholesterol in humans after one week of treatment with 50 g of fresh broccoli sprouts given daily, our daily dose had twice the glucosinolate content, comparable to 100 g fresh sprouts. We used dried broccoli sprouts as opposed to fresh sprouts, since other studies have shown a rather fast deterioration of the glucosinolate content in fresh broccoliChecklist S1CONSORT Checklist.(0.19 MB DOC)Click here for additional data file.Protocol S1Trial Protocol, in Danish.(0.10 MB DOC)Click here for additional data file."]}
{"representative": "Objective To assess whether non-polluting, more effective home heating  has a positive effect on the health of children with asthma.Design Randomised controlled trial.Setting Households in five communities in New Zealand.Participants 409 children aged 6-12 years with doctor diagnosed asthma.Interventions Installation of a non-polluting, more effective home heater before winter. The control group received a replacement heater at the end of the trial.Main outcome measures The primary outcome was change in lung function . Secondary outcomes were child reported respiratory tract symptoms and daily use of preventer and reliever drugs. At the end of winter 2005 (baseline) and winter 2006 (follow-up) parents reported their child\u2019s general health, use of health services, overall respiratory health, and housing conditions. Nitrogen dioxide levels were measured monthly for four months and temperatures in the living room and child\u2019s bedroom were recorded hourly.Results Improvements in lung function were not significant . Compared with children in the control group, however, children in the intervention group had 1.80 fewer days off school , 0.40 fewer visits to a doctor for asthma (0.11 to 0.62), and 0.25 fewer visits to a pharmacist for asthma (0.09 to 0.32). Children in the intervention group also had fewer reports of poor health , less sleep disturbed by wheezing , less dry cough at night , and reduced scores for lower respiratory tract symptoms  than children in the control group. The intervention was associated with a mean temperature rise in the living room of 1.10\u00b0C  and in the child\u2019s bedroom of 0.57\u00b0C (0.05\u00b0C to 1.08\u00b0C). Lower levels of nitrogen dioxide were measured in the living rooms of the intervention households than in those of the control households . A similar effect was found in the children\u2019s bedrooms .Conclusion Installing non-polluting, more effective heating in the homes of children with asthma did not significantly improve lung function but did significantly reduce symptoms of asthma, days off school, healthcare utilisation, and visits to a pharmacist.Trial registration Clinical Trials NCT00489762. Asthma is one of the most prevalent chronic diseases in childhood. In New Zealand about 25% of children report symptoms of asthma, and asthma is the second most common reason for children being admitted to hospital.4Evidence is growing that symptoms of asthma can be aggravated or triggered by adverse aspects of the indoor environment.9As well as cold temperatures, factors such as damp, mould, and pollutants  have been implicated in aggravating the symptoms of asthma.12Infants and elderly people spend proportionally more time indoors15Nitrogen dioxide has been widely used as a marker for outdoor air quality in studies of pollution related to vehicle emissions, but the most important source of personal exposure to nitrogen dioxide is unflued gas appliances.23Nitrogen dioxide is a proinflammatory gas and can exacerbate respiratory symptoms such as wheeze or cough. It can reduce immunity to lung infections and increase the severity and duration of an episode of flu.32Relatively few intervention studies have examined the effects of housing improvements on health and fewer still have shown an impact on symptoms of asthma.37We previously carried out a randomised controlled trial of the effects on respiratory health of insulating homes.We carried out a randomised controlled trial in which baseline measures were collected in winter (June to September) 2005. Households in the intervention group were allocated a non-polluting, more effective replacement heater  before the follow-up winter of 2006. The control group received a similar heater in 2007, after the final data collection in 2006.The study was carried out in five areas in New Zealand\u2014Porirua and the Hutt Valley in the North Island and Christchurch, Dunedin, and Bluff in the South Island. Households were recruited from December 2004 to May 2005. We identified community coordinators in nine local asthma societies and primary health organisations . The community coordinators invited families who had a child with asthma to participate in the study. The study was also publicised in radio interviews. Overall, 899 applications were received of which 422 (47%) met the inclusion criteria: the family lived in a study area and had a child aged between 6 and 12 years with doctor diagnosed asthma and symptoms in the past 12 months; the child slept at least four nights a week in the house; the house contained a less effective form of heating (unflued gas or plug-in electric heaters); the family intended to live in the house over the two winter periods; and the homeowner agreed that the household could take part in the study. If more than one child in a household met the study criteria then the child whose birthday occurred first after 1 June became the index child.After enrolment and before winter 2005 participating houses were insulated to the current New Zealand building code standard, as our previous study had shown positive effects from insulation alone.1), and correct placement of temperature loggers and nitrogen dioxide diffusion tubes. At the end of winter 2005 the community coordinators assisted households in completing the questionnaires. To check for reporting bias we included three outcomes for which we hypothesised no association with the intervention: diarrhoea, vomiting, and ear infections. The questionnaires are available at www.wnmeds.ac.nz/healthyhousing.html.The research team trained the community coordinators in the informed consent procedures, completion of questionnaires and symptom diaries, use of Piko meters  for measuring peak expiratory flow rate and forced expiratory volume in one second  were explained at community meetings and described on the research group\u2019s website. The homeowners chose a replacement for their existing heaters. Landlords were encouraged to consider their tenants\u2019 preferences. An independent statistician then randomised the households to intervention or control groups, stratified by area and heater choice. The heaters were installed in the intervention houses before winter 2006. The control group were told that they would receive a replacement heater at the end of the study.Baseline measures were repeated after the intervention at follow-up in winter 2006. In 2006 we changed the format of the questionnaire, eliminating the instruction that if people answered no to the question on wheeze they were to skip related questions, and we added a question on twisted ankles to check for reporting bias. We changed the method of recording the data from the Piko meter to recording readings in the symptom diary, as the downloaded data from 2005 were unsatisfactory. The temperature loggers were reprogrammed to record temperature every hour instead of every 20 minutes and to remain in place for the whole winter. We re-emphasised to the community coordinators the need for accuracy and timely retrieval of data.Participants signed informed consent forms. Parents signed on behalf of their children. Households were told that the heaters were the property of the homeowner.The primary outcome measure was changes to lung function. The study was powered to show a reduction in the amplitude of diurnal changes, expressed as a percentage of their mean peak expiratory flow rate over winter (amplitude % mean). A total of 430 children were required to detect a 15% reduction in the intervention group compared with the control group, assuming a correlation with the previous year\u2019s measurement of 0.4, with 90% power, \u03b1 at 0.05, and a 15% non-response rate. Secondary outcomes were reported asthma symptoms, scores for lower respiratory tract symptoms from the diaries, asthma drug use, healthcare utilisation, and days off school. Intermediate outcomes were temperature and nitrogen dioxide levels in the living room and child\u2019s bedroom.www.r-project.org/). The binary information  was analysed using both standard generalised linear models and analysis of covariance (adjusting for outcome at baseline) generalised linear models with the logistic link function. From these models we derived unadjusted odds ratios  as measures of effect size and adjusted odds ratios  as measures for precision of estimates. We similarly analysed the numerical counts  but with a Poisson link function. For these models we present the change for the intervention group compared with the control group as mean number of events, with 95% confidence intervals.Epi-Info version 3.4.1  was used to double enter the responses to the questionnaire and data from the diaries. We cleaned and analysed the data using the statistical package R version 2.4.1 , we used the overall mean and validated the results using the complete data. Results for the interpolated data were predominantly within 5% of the results for the non-interpolated data.1 and peak expiratory flow rate from three good forced expiratory manoeuvres, measured each morning and evening. The three outcomes presented are the best blow in the morning, in the evening, and that day.In the daily diaries individual respiratory symptoms were recorded on a nominal scale (0 to 3) as used previously.1.For all daily records we used a linear mixed modelWe tested model distributions by examining the dispersion variable in the Poisson models and QQ plots for the normal models. Ethnicity was collected using the standardised self identity question of Statistics New Zealand. When multiple ethnicities were reported we used prioritised M\u0101ori and then Pacific ethnicities.41Overall, 409 households were randomised. After exclusions and withdrawals 349 (85%) households remained  and daily peak expiratory flow rate .Table 2v good, very good, excellent) by their parents . Parental reports showed a reduction in sleep disturbed by wheeze  and dry cough at night .The other three symptoms  improved but not significantly. Of the four outcomes used to test for reporting bias  only twisted ankles showed a significant effect.Table 3Results from the daily symptom diaries are presented as mean ratios\u2014the average score for the intervention group divided by the average score for the control group , 0.4 fewer visits to the doctor for asthma , 0.25 fewer visits to a pharmacist for asthma , and 0.27 fewer visits to the doctor for non-asthma related conditions .After the intervention, during the winter of 2006, the average living room temperature of intervention households was 17.07\u00b0C compared with 15.97\u00b0C for control households: a difference of 1.10\u00b0C . Similarly, the average temperature in the child\u2019s bedroom for intervention households was 14.84\u00b0C compared with 14.26\u00b0C for control households: a mean difference of 0.57\u00b0C .Exposure to low temperatures, measured as degree hours\u2014that is, hours per day, multiplied by number of degrees less than 10\u00b0C\u2014was over 50% less in the intervention group than control group. In the living room the exposure was 1.13 degree hours in the intervention group compared with 2.31 degree hours in the control group, a difference of 1.18 degree hours . Exposure in the child\u2019s bedroom was 2.03 degree hours in the intervention group compared with 4.29 degree hours in the control group, a difference of 2.26 degree hours .3v 15.7 \u03bcg/m3, P<0.001). A similar significant effect was found in the child\u2019s bedroom .42Ambient outdoor nitrogen dioxide levels were the same in both groups, but indoor levels were significantly reduced in the intervention group. In 2006 the intervention group had significantly (P<0.001) lower geometric mean nitrogen dioxide levels in the living room than the control group  compared with the average cost of the unflued gas or portable electric heater ($NZ100 per house).The major limitation in randomised trials of this sort is the impossibility of implementing blinding of the participants or field workers, once they visited the home. This could have resulted in a reporting bias, although as all participants knew at the outset of the study that they would receive new heaters it is unclear in which direction this would be. However, the outcome measurements included both self report and blinded measures and when both were available, as with days off school, the blinded measures showed a greater effect, suggesting any reporting bias was in the direction of minimising the intervention effect. In addition, three of the four questions that tested for reporting bias were not significantly affected by the intervention. The other outcome (twisted ankles) showed increased reporting in the intervention group, also suggesting that any bias was in the direction of minimising the effect of the intervention.Another important issue is the choice of primary outcome measure; we chose lung function because it was more objective and because the study could not be double blinded. It may be that lung function is less important to the daily life of children with asthma than are the frequency and severity of symptoms. In addition symptoms may be more sensitive to change and more reliable than laboratory based measures carried out by children in a community setting.As highlighted by one study, managing a community trial with community organisations as partners is challenging for all parties.The results suggest that improving both the type and amount of heating in the homes of children with asthma does not significantly affect measured lung function but does have several beneficial effects. Houses in this study included all forms of tenure, and the households had a range of incomes, so apportioning the relative benefits to the participants and to the public good is an important policy issue. In the United Kingdom, Scotland has made the policy decision that installing central heating in all social and pensioner housing, regardless of tenure, is largely for the good of the public and will pay more health dividends than focusing on clinical waiting lists, as is done in England.47Although the improvement in lung function was not statistically significant, large improvements were found in the symptoms of asthma. These patient centred measures are arguably as important to the daily life of children with asthma as more objective measures, and adopting this environmental intervention is an effective adjunct to the pharmaceutical treatment of asthma symptoms.Observational, but few intervention, studies have shown associations between asthma symptoms and dampness and cold in poorly heated homesNon-polluting, effective heating did not significantly affect measured lung function of children with asthma but it improved wellbeing and reduced symptoms of asthma and days off school", "texts": ["Objective To assess whether non-polluting, more effective home heating  has a positive effect on the health of children with asthma.Design Randomised controlled trial.Setting Households in five communities in New Zealand.Participants 409 children aged 6-12 years with doctor diagnosed asthma.Interventions Installation of a non-polluting, more effective home heater before winter. The control group received a replacement heater at the end of the trial.Main outcome measures The primary outcome was change in lung function . Secondary outcomes were child reported respiratory tract symptoms and daily use of preventer and reliever drugs. At the end of winter 2005 (baseline) and winter 2006 (follow-up) parents reported their child\u2019s general health, use of health services, overall respiratory health, and housing conditions. Nitrogen dioxide levels were measured monthly for four months and temperatures in the living room and child\u2019s bedroom were recorded hourly.Results Improvements in lung function were not significant . Compared with children in the control group, however, children in the intervention group had 1.80 fewer days off school , 0.40 fewer visits to a doctor for asthma (0.11 to 0.62), and 0.25 fewer visits to a pharmacist for asthma (0.09 to 0.32). Children in the intervention group also had fewer reports of poor health , less sleep disturbed by wheezing , less dry cough at night , and reduced scores for lower respiratory tract symptoms  than children in the control group. The intervention was associated with a mean temperature rise in the living room of 1.10\u00b0C  and in the child\u2019s bedroom of 0.57\u00b0C (0.05\u00b0C to 1.08\u00b0C). Lower levels of nitrogen dioxide were measured in the living rooms of the intervention households than in those of the control households . A similar effect was found in the children\u2019s bedrooms .Conclusion Installing non-polluting, more effective heating in the homes of children with asthma did not significantly improve lung function but did significantly reduce symptoms of asthma, days off school, healthcare utilisation, and visits to a pharmacist.Trial registration Clinical Trials NCT00489762. Asthma is one of the most prevalent chronic diseases in childhood. In New Zealand about 25% of children report symptoms of asthma, and asthma is the second most common reason for children being admitted to hospital.4Evidence is growing that symptoms of asthma can be aggravated or triggered by adverse aspects of the indoor environment.9As well as cold temperatures, factors such as damp, mould, and pollutants  have been implicated in aggravating the symptoms of asthma.12Infants and elderly people spend proportionally more time indoors15Nitrogen dioxide has been widely used as a marker for outdoor air quality in studies of pollution related to vehicle emissions, but the most important source of personal exposure to nitrogen dioxide is unflued gas appliances.23Nitrogen dioxide is a proinflammatory gas and can exacerbate respiratory symptoms such as wheeze or cough. It can reduce immunity to lung infections and increase the severity and duration of an episode of flu.32Relatively few intervention studies have examined the effects of housing improvements on health and fewer still have shown an impact on symptoms of asthma.37We previously carried out a randomised controlled trial of the effects on respiratory health of insulating homes.We carried out a randomised controlled trial in which baseline measures were collected in winter (June to September) 2005. Households in the intervention group were allocated a non-polluting, more effective replacement heater  before the follow-up winter of 2006. The control group received a similar heater in 2007, after the final data collection in 2006.The study was carried out in five areas in New Zealand\u2014Porirua and the Hutt Valley in the North Island and Christchurch, Dunedin, and Bluff in the South Island. Households were recruited from December 2004 to May 2005. We identified community coordinators in nine local asthma societies and primary health organisations . The community coordinators invited families who had a child with asthma to participate in the study. The study was also publicised in radio interviews. Overall, 899 applications were received of which 422 (47%) met the inclusion criteria: the family lived in a study area and had a child aged between 6 and 12 years with doctor diagnosed asthma and symptoms in the past 12 months; the child slept at least four nights a week in the house; the house contained a less effective form of heating (unflued gas or plug-in electric heaters); the family intended to live in the house over the two winter periods; and the homeowner agreed that the household could take part in the study. If more than one child in a household met the study criteria then the child whose birthday occurred first after 1 June became the index child.After enrolment and before winter 2005 participating houses were insulated to the current New Zealand building code standard, as our previous study had shown positive effects from insulation alone.1), and correct placement of temperature loggers and nitrogen dioxide diffusion tubes. At the end of winter 2005 the community coordinators assisted households in completing the questionnaires. To check for reporting bias we included three outcomes for which we hypothesised no association with the intervention: diarrhoea, vomiting, and ear infections. The questionnaires are available at www.wnmeds.ac.nz/healthyhousing.html.The research team trained the community coordinators in the informed consent procedures, completion of questionnaires and symptom diaries, use of Piko meters  for measuring peak expiratory flow rate and forced expiratory volume in one second  were explained at community meetings and described on the research group\u2019s website. The homeowners chose a replacement for their existing heaters. Landlords were encouraged to consider their tenants\u2019 preferences. An independent statistician then randomised the households to intervention or control groups, stratified by area and heater choice. The heaters were installed in the intervention houses before winter 2006. The control group were told that they would receive a replacement heater at the end of the study.Baseline measures were repeated after the intervention at follow-up in winter 2006. In 2006 we changed the format of the questionnaire, eliminating the instruction that if people answered no to the question on wheeze they were to skip related questions, and we added a question on twisted ankles to check for reporting bias. We changed the method of recording the data from the Piko meter to recording readings in the symptom diary, as the downloaded data from 2005 were unsatisfactory. The temperature loggers were reprogrammed to record temperature every hour instead of every 20 minutes and to remain in place for the whole winter. We re-emphasised to the community coordinators the need for accuracy and timely retrieval of data.Participants signed informed consent forms. Parents signed on behalf of their children. Households were told that the heaters were the property of the homeowner.The primary outcome measure was changes to lung function. The study was powered to show a reduction in the amplitude of diurnal changes, expressed as a percentage of their mean peak expiratory flow rate over winter (amplitude % mean). A total of 430 children were required to detect a 15% reduction in the intervention group compared with the control group, assuming a correlation with the previous year\u2019s measurement of 0.4, with 90% power, \u03b1 at 0.05, and a 15% non-response rate. Secondary outcomes were reported asthma symptoms, scores for lower respiratory tract symptoms from the diaries, asthma drug use, healthcare utilisation, and days off school. Intermediate outcomes were temperature and nitrogen dioxide levels in the living room and child\u2019s bedroom.www.r-project.org/). The binary information  was analysed using both standard generalised linear models and analysis of covariance (adjusting for outcome at baseline) generalised linear models with the logistic link function. From these models we derived unadjusted odds ratios  as measures of effect size and adjusted odds ratios  as measures for precision of estimates. We similarly analysed the numerical counts  but with a Poisson link function. For these models we present the change for the intervention group compared with the control group as mean number of events, with 95% confidence intervals.Epi-Info version 3.4.1  was used to double enter the responses to the questionnaire and data from the diaries. We cleaned and analysed the data using the statistical package R version 2.4.1 , we used the overall mean and validated the results using the complete data. Results for the interpolated data were predominantly within 5% of the results for the non-interpolated data.1 and peak expiratory flow rate from three good forced expiratory manoeuvres, measured each morning and evening. The three outcomes presented are the best blow in the morning, in the evening, and that day.In the daily diaries individual respiratory symptoms were recorded on a nominal scale (0 to 3) as used previously.1.For all daily records we used a linear mixed modelWe tested model distributions by examining the dispersion variable in the Poisson models and QQ plots for the normal models. Ethnicity was collected using the standardised self identity question of Statistics New Zealand. When multiple ethnicities were reported we used prioritised M\u0101ori and then Pacific ethnicities.41Overall, 409 households were randomised. After exclusions and withdrawals 349 (85%) households remained  and daily peak expiratory flow rate .Table 2v good, very good, excellent) by their parents . Parental reports showed a reduction in sleep disturbed by wheeze  and dry cough at night .The other three symptoms  improved but not significantly. Of the four outcomes used to test for reporting bias  only twisted ankles showed a significant effect.Table 3Results from the daily symptom diaries are presented as mean ratios\u2014the average score for the intervention group divided by the average score for the control group , 0.4 fewer visits to the doctor for asthma , 0.25 fewer visits to a pharmacist for asthma , and 0.27 fewer visits to the doctor for non-asthma related conditions .After the intervention, during the winter of 2006, the average living room temperature of intervention households was 17.07\u00b0C compared with 15.97\u00b0C for control households: a difference of 1.10\u00b0C . Similarly, the average temperature in the child\u2019s bedroom for intervention households was 14.84\u00b0C compared with 14.26\u00b0C for control households: a mean difference of 0.57\u00b0C .Exposure to low temperatures, measured as degree hours\u2014that is, hours per day, multiplied by number of degrees less than 10\u00b0C\u2014was over 50% less in the intervention group than control group. In the living room the exposure was 1.13 degree hours in the intervention group compared with 2.31 degree hours in the control group, a difference of 1.18 degree hours . Exposure in the child\u2019s bedroom was 2.03 degree hours in the intervention group compared with 4.29 degree hours in the control group, a difference of 2.26 degree hours .3v 15.7 \u03bcg/m3, P<0.001). A similar significant effect was found in the child\u2019s bedroom .42Ambient outdoor nitrogen dioxide levels were the same in both groups, but indoor levels were significantly reduced in the intervention group. In 2006 the intervention group had significantly (P<0.001) lower geometric mean nitrogen dioxide levels in the living room than the control group  compared with the average cost of the unflued gas or portable electric heater ($NZ100 per house).The major limitation in randomised trials of this sort is the impossibility of implementing blinding of the participants or field workers, once they visited the home. This could have resulted in a reporting bias, although as all participants knew at the outset of the study that they would receive new heaters it is unclear in which direction this would be. However, the outcome measurements included both self report and blinded measures and when both were available, as with days off school, the blinded measures showed a greater effect, suggesting any reporting bias was in the direction of minimising the intervention effect. In addition, three of the four questions that tested for reporting bias were not significantly affected by the intervention. The other outcome (twisted ankles) showed increased reporting in the intervention group, also suggesting that any bias was in the direction of minimising the effect of the intervention.Another important issue is the choice of primary outcome measure; we chose lung function because it was more objective and because the study could not be double blinded. It may be that lung function is less important to the daily life of children with asthma than are the frequency and severity of symptoms. In addition symptoms may be more sensitive to change and more reliable than laboratory based measures carried out by children in a community setting.As highlighted by one study, managing a community trial with community organisations as partners is challenging for all parties.The results suggest that improving both the type and amount of heating in the homes of children with asthma does not significantly affect measured lung function but does have several beneficial effects. Houses in this study included all forms of tenure, and the households had a range of incomes, so apportioning the relative benefits to the participants and to the public good is an important policy issue. In the United Kingdom, Scotland has made the policy decision that installing central heating in all social and pensioner housing, regardless of tenure, is largely for the good of the public and will pay more health dividends than focusing on clinical waiting lists, as is done in England.47Although the improvement in lung function was not statistically significant, large improvements were found in the symptoms of asthma. These patient centred measures are arguably as important to the daily life of children with asthma as more objective measures, and adopting this environmental intervention is an effective adjunct to the pharmaceutical treatment of asthma symptoms.Observational, but few intervention, studies have shown associations between asthma symptoms and dampness and cold in poorly heated homesNon-polluting, effective heating did not significantly affect measured lung function of children with asthma but it improved wellbeing and reduced symptoms of asthma and days off school"]}
{"representative": "Hypertension is a major chronic lifestyle disease. Several non-pharmacological interventions are effective in bringing down the blood pressure (BP). This study focuses on the effectiveness of such interventions among young adults.To measure the efficacy of physical exercise, reduction in salt intake, and yoga, in lowering BP among young (20-25) pre-hypertensives and hypertensives, and to compare their relative efficacies.The study was done in the urban service area of JIPMER. Pre-hypertensives and hypertensives, identified from previous studies, constituted the universe. The participants were randomized into one control and three interventional groups.A total of 113 subjects: 30, 28, 28 and 27 in four groups respectively participated for eight weeks: control (I), physical exercise (II) - brisk walking for 50-60 minutes, four days/week, salt intake reduction (III) - to at least half of their previous intake, and practice of yoga (IV) - for 30-45 minutes/day on at least five days/week.Efficacy was assessed using paired t test and ANOVA with Games Howell post hoc test. An intention to treat analysis was also performed.A total of 102 participants  completed the study. All three intervention groups showed a significant reduction in BP . There was no significant change (SBP/DBP: 0.2/0.5 mmHg) of BP in control group (I). Physical exercise was most effective ; salt intake reduction and yoga were also effective.Physical exercise, salt intake reduction, and yoga are effective non-pharmacological interventions in significantly reducing BP among young hypertensives and pre-hypertensives. These can therefore be positively recommended for hypertensives. There is also a case to deploy these interventions in the general population. Hypertension is a major chronic lifestyle disease and an important public health problem worldwide. A recent report indicates that nearly one billion adults had hypertension in 2000, and this is predicted to increase to 1.56 billion by 2025.There are several non-pharmacological methods of controlling blood pressure (BP). physical12young adults through non-pharmacological interventions at an early stage of the natural history of the disease, and compares their relative efficacies in reducing BP and hence the objectives,This study focuses on tackling these important risk factors of hypertension among To measure the efficacy of the following interventions in lowering BP among young (20-25) pre- hypertensives and hypertensives:Physical exerciseReduction in salt intake andPractice of yogaTo compare the relative efficacies of these three interventions.51 hypertensives and 173 pre-hypertensives, as per the JNC VII criteria for classification of pre-hypertension (120-139 mm Hg SBP and/or 80-89 mm Hg DBP).. Since itOf the 120, seven participants (three hypertensives plus four pre-hypertensives) did not consent to be part of the program, while 30, 28, 28 and 27 in the control, physical exercise, salt intake reduction and yoga groups respectively consented amounting to a total of 113 study subjects . The pathogenesis, risk factors, complications and therapy of hypertension was explained to the participants in the local language, Tamil, so as to motivate them for compliance. Their blood pressure was measured at the start of the study period using the mercury sphygmomanometer.Participants of this group were motivated to undergo physical exercise in the form of brisk walking for 50-60 minutes, four days per week.\u201317 As a These subjects were motivated to reduce their daily salt intake to at least half of their previous intake.1819 Data1812asanas proved to be effective in BP reduction(pranayama (breathing exercises); and asanas like savasana, ardha matsyendrasana, naadishudhi asana, single leg, and double leg raise.This group of participants was taught yoga reduction21) by a  by a asareduction This incAll these interventions were carried out for eight weeks. Flexibility was allowed for those who took time for motivation and started the intervention at subsequent dates; however they were followed up for the corresponding eight-week period. At the end of the study period their BP values were measured.Out of the initial 113, 11 subjects (including 6 hypertensives) dropped out. At the end of the study 29, 27, 25 and 21 in the groups I, II, III and IV respectively  were successfully followed through.The study was approved by the Institute Research Council and Institute Ethics Committee. Informed consent was obtained from all the participants.The pre-intervention and the post-intervention BP values were analyzed using the paired \u2018t\u2019 test. \u2018Intention to treat\u2019 analysis was carried out by including the attrition cohort. The inter-group comparisons were made using ANOVA with Games Howell post hoc test.Of the 102 participants who completed the study, 68 were males and 34 females. Age distribution concurred in all groups. The male-female distribution was similar in all groups except a slight over-representation in the salt intake reduction group. During course of the study one, one, three and five participants dropped out from groups I, II, III and IV respectively. The mean systolic BP in the four groups ranged between 123 and 128 mm Hg and the diastolic blood pressure between 82 and 87 mm Hg. Considering those who completed the study, the baseline mean SBP and DBP of the four groups differed significantly; this could be due to their differential attrition patterns. The distribution of hypertensives among the groups is also significantly different due to the effect of attrition .P less than 0.05 in each case) compared to the control group wherein the fall was not significant [P less than 0.05 in each case) whereas the change in the DBP values of the control group was not significant [As regards SBP in the pre and post intervention setting, in the physical exercise group there was a reduction from 128.6 to 123.3 (5.3), in the salt intake reduction group from 124.0 to 121.4 (2.6), in the yoga group from 126.8 to 124.8 (2.0), and in the control group from 123.1 to 122.9 (0.2). This fall in SBP in each of the interventional groups was statistically significant  and physical exercise Vs practice of yoga . However, when the effectiveness of salt intake reduction and yoga were compared, there was no significant difference [P is equal to 0.002) and Physical exercise vs practice of yoga  showed statistically significant differences. Here too, salt intake reduction Vs practice of yoga showed no significant difference [After checking for normality using Kolmogrov-Smirnov test, ANOVA was done with Games-Howell post hoc test as Levene's test for equal variance was significant. On analysis of the relative efficacies, considering SBP, there were statistically significant differences with Physical exercise Vs salt intake reduction  was recorded. This study found physical exercise and salt restriction to be more acceptable than yoga at the community level.This study has highlighted the effectiveness of physical exercise, salt intake reduction and yoga in prevention and control of hypertension among young adults. A comparative discussion of these variables follows.et al. whereas both salt intake reduction and yoga were equally effective as non-pharmacological interventions for prevention and control of hypertension among young adults. In a recent meta-analysis, de Luis et al. demonstrComparable attrition rates (3%) in the physical exercise and the control groups highlight the high acceptability of physical exercise. Salt restriction group also registered a high acceptability of 90%. Even in the yoga group, the acceptability was as high as 78%.The WHO document on \u2018Community Prevention and Control of Cardiovascular Diseases\u2019 providesAn attrition rate of 9.7%  was recorded during the course of this study.The study assumed that all participants underwent the same magnitude of intervention. There could have been variations in the extent of compliance among members of the same interventional group. The study did not have any mechanism to standardize or quantify the actual magnitude of intervention per individual.", "texts": ["Hypertension is a major chronic lifestyle disease. Several non-pharmacological interventions are effective in bringing down the blood pressure (BP). This study focuses on the effectiveness of such interventions among young adults.To measure the efficacy of physical exercise, reduction in salt intake, and yoga, in lowering BP among young (20-25) pre-hypertensives and hypertensives, and to compare their relative efficacies.The study was done in the urban service area of JIPMER. Pre-hypertensives and hypertensives, identified from previous studies, constituted the universe. The participants were randomized into one control and three interventional groups.A total of 113 subjects: 30, 28, 28 and 27 in four groups respectively participated for eight weeks: control (I), physical exercise (II) - brisk walking for 50-60 minutes, four days/week, salt intake reduction (III) - to at least half of their previous intake, and practice of yoga (IV) - for 30-45 minutes/day on at least five days/week.Efficacy was assessed using paired t test and ANOVA with Games Howell post hoc test. An intention to treat analysis was also performed.A total of 102 participants  completed the study. All three intervention groups showed a significant reduction in BP . There was no significant change (SBP/DBP: 0.2/0.5 mmHg) of BP in control group (I). Physical exercise was most effective ; salt intake reduction and yoga were also effective.Physical exercise, salt intake reduction, and yoga are effective non-pharmacological interventions in significantly reducing BP among young hypertensives and pre-hypertensives. These can therefore be positively recommended for hypertensives. There is also a case to deploy these interventions in the general population. Hypertension is a major chronic lifestyle disease and an important public health problem worldwide. A recent report indicates that nearly one billion adults had hypertension in 2000, and this is predicted to increase to 1.56 billion by 2025.There are several non-pharmacological methods of controlling blood pressure (BP). physical12young adults through non-pharmacological interventions at an early stage of the natural history of the disease, and compares their relative efficacies in reducing BP and hence the objectives,This study focuses on tackling these important risk factors of hypertension among To measure the efficacy of the following interventions in lowering BP among young (20-25) pre- hypertensives and hypertensives:Physical exerciseReduction in salt intake andPractice of yogaTo compare the relative efficacies of these three interventions.51 hypertensives and 173 pre-hypertensives, as per the JNC VII criteria for classification of pre-hypertension (120-139 mm Hg SBP and/or 80-89 mm Hg DBP).. Since itOf the 120, seven participants (three hypertensives plus four pre-hypertensives) did not consent to be part of the program, while 30, 28, 28 and 27 in the control, physical exercise, salt intake reduction and yoga groups respectively consented amounting to a total of 113 study subjects . The pathogenesis, risk factors, complications and therapy of hypertension was explained to the participants in the local language, Tamil, so as to motivate them for compliance. Their blood pressure was measured at the start of the study period using the mercury sphygmomanometer.Participants of this group were motivated to undergo physical exercise in the form of brisk walking for 50-60 minutes, four days per week.\u201317 As a These subjects were motivated to reduce their daily salt intake to at least half of their previous intake.1819 Data1812asanas proved to be effective in BP reduction(pranayama (breathing exercises); and asanas like savasana, ardha matsyendrasana, naadishudhi asana, single leg, and double leg raise.This group of participants was taught yoga reduction21) by a  by a asareduction This incAll these interventions were carried out for eight weeks. Flexibility was allowed for those who took time for motivation and started the intervention at subsequent dates; however they were followed up for the corresponding eight-week period. At the end of the study period their BP values were measured.Out of the initial 113, 11 subjects (including 6 hypertensives) dropped out. At the end of the study 29, 27, 25 and 21 in the groups I, II, III and IV respectively  were successfully followed through.The study was approved by the Institute Research Council and Institute Ethics Committee. Informed consent was obtained from all the participants.The pre-intervention and the post-intervention BP values were analyzed using the paired \u2018t\u2019 test. \u2018Intention to treat\u2019 analysis was carried out by including the attrition cohort. The inter-group comparisons were made using ANOVA with Games Howell post hoc test.Of the 102 participants who completed the study, 68 were males and 34 females. Age distribution concurred in all groups. The male-female distribution was similar in all groups except a slight over-representation in the salt intake reduction group. During course of the study one, one, three and five participants dropped out from groups I, II, III and IV respectively. The mean systolic BP in the four groups ranged between 123 and 128 mm Hg and the diastolic blood pressure between 82 and 87 mm Hg. Considering those who completed the study, the baseline mean SBP and DBP of the four groups differed significantly; this could be due to their differential attrition patterns. The distribution of hypertensives among the groups is also significantly different due to the effect of attrition .P less than 0.05 in each case) compared to the control group wherein the fall was not significant [P less than 0.05 in each case) whereas the change in the DBP values of the control group was not significant [As regards SBP in the pre and post intervention setting, in the physical exercise group there was a reduction from 128.6 to 123.3 (5.3), in the salt intake reduction group from 124.0 to 121.4 (2.6), in the yoga group from 126.8 to 124.8 (2.0), and in the control group from 123.1 to 122.9 (0.2). This fall in SBP in each of the interventional groups was statistically significant  and physical exercise Vs practice of yoga . However, when the effectiveness of salt intake reduction and yoga were compared, there was no significant difference [P is equal to 0.002) and Physical exercise vs practice of yoga  showed statistically significant differences. Here too, salt intake reduction Vs practice of yoga showed no significant difference [After checking for normality using Kolmogrov-Smirnov test, ANOVA was done with Games-Howell post hoc test as Levene's test for equal variance was significant. On analysis of the relative efficacies, considering SBP, there were statistically significant differences with Physical exercise Vs salt intake reduction  was recorded. This study found physical exercise and salt restriction to be more acceptable than yoga at the community level.This study has highlighted the effectiveness of physical exercise, salt intake reduction and yoga in prevention and control of hypertension among young adults. A comparative discussion of these variables follows.et al. whereas both salt intake reduction and yoga were equally effective as non-pharmacological interventions for prevention and control of hypertension among young adults. In a recent meta-analysis, de Luis et al. demonstrComparable attrition rates (3%) in the physical exercise and the control groups highlight the high acceptability of physical exercise. Salt restriction group also registered a high acceptability of 90%. Even in the yoga group, the acceptability was as high as 78%.The WHO document on \u2018Community Prevention and Control of Cardiovascular Diseases\u2019 providesAn attrition rate of 9.7%  was recorded during the course of this study.The study assumed that all participants underwent the same magnitude of intervention. There could have been variations in the extent of compliance among members of the same interventional group. The study did not have any mechanism to standardize or quantify the actual magnitude of intervention per individual."]}
{"representative": "Even though depression and anxiety are highly prevalent in adolescence, youngsters are not inclined to seek help in regular healthcare. Therapy through the Internet, however, has been found to appeal strongly to young people. The main aim of the present study is to examine the efficacy of preventive Internet-based guided self-help problem-solving therapy with adolescents reporting depressive and anxiety symptoms. A secondary objective is to test potential mediating and moderating variables in order to gain insight into how the intervention works and for whom it works best.This study is a randomized controlled trial with an intervention condition group and a wait-list control group. The intervention condition group receives Internet-based self-help problem-solving therapy. Support is provided by a professional and delivered through email. Participants in the wait-list control group receive the intervention four months later. The study population consists of adolescents (12-18-year-olds) from the general population who report mild to moderate depressive and/or anxiety symptoms and are willing to complete a self-help course. Primary outcomes are symptoms of depression and anxiety. Secondary outcomes are quality of life, social anxiety, and cost-effectiveness. The following variables are examined for their moderating role: demographics, motivation, treatment credibility and expectancy, externalizing behaviour, perceived social support from parents and friends, substance use, the experience of important life events, physical activity, the quality of the therapeutic alliance, and satisfaction. Mediator variables include problem-solving skills, worrying, mastery, and self-esteem. Data are collected at baseline and at 3 weeks, 5 weeks, 4 months, 8 months, and 12 months after baseline. Both intention-to-treat and completer analyses will be conducted.This study evaluates the efficacy and mechanisms of Internet-based problem-solving therapy for adolescents. If Internet-based problem-solving therapy is shown to reduce depressive and anxiety symptoms in adolescents, the implication is to implement the intervention in clinical practice. Strengths and limitations of the study are discussed.Netherlands Trial Register NTR1322 Depression and anxiety disorders are the most prevalent mental disorders in adolescence, with lifetime prevalences between 17% and 28% by the age of 18 . FurtherDespite the high incidence of common mental health problems in adolescence, teenagers rarely seek professional help for their emotional problems through regular healthcare services. The Internet, however, offers the possibility to access this large group of untreated adolescents for adequate care: it has low threshold acceptability, is used frequently by young people, and reduces objections like lack of willingness to talk to a stranger about personal problems and fear of stigma . A recenFor adults, preventive self-help interventions have been offered through the Internet and proven to be effective in reducing symptoms of depression and anxiety e.g., -21). Sel. Sel21])Most web-based self-help interventions for psychological problems have been developed for treating (symptoms of) specific disorders like depression or a specific anxiety disorder. Face-to-face problem-solving therapy (PST), on the other hand, has been found to be effective in a variety of problem areas ,26. A neWhile Internet-based self-help is effective in adults, it is still unknown whether these interventions also work for adolescents. Also, little is known with regard to the mechanisms underlying change in this form of treatment and potential predictors of treatment effect. For the current study, the Dutch Internet-based PST intervention  was adapIn the present study, we examine the effects of an Internet-based guided self-help intervention (PST) for adolescents reporting mild to moderate symptoms of depression and/or anxiety compared to a wait-list control group. Potential moderating and mediating variables are investigated in order to identify predictors of treatment effect and to evaluate potential underlying mechanisms of change. Moderating variables are explored, i.e., demographics, motivation, treatment credibility and expectancy, externalizing behaviour, peer and parental perceived social support, substance use, the experience of life events, physical activity, the working alliance between participant and coach, and satisfaction. Problem-solving abilities, mastery, self-esteem and ruminative responses are investigated for their possible mediating effect.This study is a randomized controlled trial with two groups: the Internet-based self-help intervention group (PST) and a wait-list control group (WL). The study protocol has been approved by the Medical Ethics Committee of the VU University Medical Center.Adolescents (12 to 18-year-olds) with mild to moderate depressive and/or anxiety symptoms who are willing to participate in a self-help course are eligible for this study. Inclusion criteria are: sufficient knowledge of the Dutch language, access to Internet, and having an email address. Exclusion criteria are: absence of parental permission, already receiving treatment for mental health problems, the presence of severe depressive symptoms , severe anxiety symptoms , and/or prominent suicide ideation .Participants are recruited through banners and advertisements on the Internet, advertisements in magazines, referral by school-doctors, through brochures and posters in schools, and through information to parents who are treated in mental health care institutions for anxiety and depression. When signing in on the website, subjects receive a brochure and an informed consent form by email. In the brochure, information about the study's procedure and intervention is provided, and requirements for participation and parental consent are carefully explained. After application by the adolescent via email, parents receive a brochure and informed consent form by post. After receiving signed informed consent from both child and parents, participants receive an email with a link to the baseline questionnaire. Subjects with a score of 41 or higher on the CES-D are excluded. They receive a telephone call in which they are advised to consult their general practitioner. Their parents are also informed by telephone. The same procedure is followed in cases of a score of 15 or higher on the anxiety subscale of the HADS and/or a score of 2 or higher on the BDI-II suicide item. Eligible adolescents are randomized to either the intervention or the wait-list control condition, and are informed about the randomization outcome by email. Their parents also receive this email. Depression and anxiety subscales of the National Institute of Mental Health Diagnostic Interview Schedule for Children (NIMH-DISC IV) are subsequently conducted by telephone. Within two weeks after the baseline measurements, the intervention starts. Assessments take place during the treatment period, at treatment termination, and 4, 8, and 12 months after the start of the intervention. Figure Participants are randomly assigned to either the intervention or a waiting list. Randomization will take place at an individual level after the baseline measurement and one week before the start of the intervention. An independent researcher will make the allocation schedule with a computerized random number generator. The random allocation list will be generated in random permuted blocks of variable size . The randomization outcome per participant will be revealed to the primary investigator after the baseline measurement. In this manner, the investigator can give some background information  to the designated coach guiding the intervention participant through the course. Though the researcher has knowledge of participants' group assignment after the baseline measure, all other measures consist of automated online questionnaires and so there will be no contact here between participants and the primary researcher at all. Adolescents agree to participate before randomization and without knowing which group they will be allocated to. Received baseline questionnaires are numbered in order of arrival.The sample size is based on the expected difference (Cohen's d = .50) between the intervention group and the wait-list control group at post-test, on the primary outcome variables, i.e., depressive and anxiety symptoms. Based on an alpha of .05 and a power of .80 in a two-tailed test, we need 63 subjects in each condition. Because Internet interventions tend to result in relatively high dropout rates of up to 40%, we aim for 210 participants. The expected effect size and dropout rate are derived from our experiences with an earlier study on the proposed intervention in adults . High drThe PST intervention is a Dutch adaptation of SET . It has PST in this study consists of several steps and takes five weeks, with one lesson a week. In the first lesson, subjects make a list of what is most important in their lives  and a list of their current worries and problems. Having listed their problems, participants subsequently divide these into three categories: (a) unimportant problems (problems unrelated to the things that matter to them), (b) important problems which can be solved, and (c) important problems which cannot be solved . In the following weeks, participants can adapt their \"important things\" and \"problem\" lists while they learn to deal with the three types of problem introduced in the first lesson.In lesson 2, subjects are taught the focal component of the intervention which is a specific six-step problem-solving procedure for structurally resolving important problems which can be solved. In the first step of this procedure, participants need to describe their problem. The next steps involve (2) writing down all possible solutions you can think of, (3) choosing the best solution, (4) describing how the solution will be carried out , (5) carrying out your plan of the solution, and (6) checking whether the problem is resolved. Participants practice with this six-step PST procedure from lesson 2 onwards; all other material and exercises only play a supporting role.Lesson 3 deals with problems unrelated to things which are important, by proposing different strategies to eliminate negative thoughts and enhance positive thoughts. Strategies to eliminate negative thoughts concern (a) establishing one or two 15-minutes sessions a day for thinking about a problem (b) forcing yourself to immediately stop negative thoughts when they pop up, and (c) distracting yourself when ruminating, e.g., by calling a friend or engaging in sports. Two exercises for positive thinking are proposed; these are (a) thinking about three things which gave you a good feeling that day, and doing this every night before going to sleep, and (b) writing as many positive thoughts  as possible on small cards, and then pulling one of these out regularly.In lesson 4 - about important problems which cannot be solved -, participants are told that there are no rules for coping with a major event, but that it usually helps not to avoid negative emotions. Avoidance can be reduced by writing about your feelings, talking about your experiences with people that you feel close to, or by getting in touch with fellow-sufferers. Links to Dutch websites for specific types of problems are provided on the website.During the fifth and last lesson, subjects look at their \"problem list\" again and are encouraged to identify the most important problem area - the problem most closely related to their feelings of depression and/or anxiety. They subsequently write down their goals concerning this problem for the long term. What are your goals for the next four months, and what are you going to do when encountering difficulties? Subjects also look at their \"important things list\" and are encouraged to think about actions they can undertake in order to reach these important things. Other exercises include making plans of how to deal with upcoming important life events which might make you feel low, and making a plan of what to do when encountering signals of depression or anxiety again; i.e., what steps they can take in order to prevent a relapse.After the last lesson the website provides some general tips for counteracting depressed and anxious feelings, and phone numbers of professional mental health institutes are supplied. Figure Subjects in the intervention group receive email support from employees of the Prevention and Intervention group of a mental health care institute in Amsterdam and the first two authors of this paper. Support is directed at guiding the participant through the intervention. This is done by sending an email if the coach does not receive participants' exercises at the end of the lesson and by commenting on the exercises made by participants. Comments include thanking the participant for sending and completing the exercises, compliments about exercises done well, asking for clarification when necessary, answering questions participants might have about the exercises, and giving tips when finding that the participant did not fully understand the exercise . When participants send their assignments to their coach, they receive feedback within three working days. Support is not intended to give direct or individual advice on how to cope with depression, anxiety or other problems. Although performing the course with email support is strongly recommended, participants are permitted to complete the intervention without support.Participants on the waiting list receive no intervention or support, only a link to a website with general information about depression and anxiety. They can commence the intervention four months after the intervention group starts the course.Screening measures, primary outcome measures, secondary outcome measures, measures of clinical predictors, and measures of mediating variables can be distinguished in this study. The instruments include a diagnostic interview by phone and self-report questionnaires which are filled in by participants through the Internet.A structured diagnostic interview and self-report questionnaires including suicidal ideation, depression, and anxiety are administered as screening measures in this study.The Diagnostic Interview Schedule for Children (version NIMH DISC-4.0) is a reliable and valid structured diagnostic interview designed for lay interviewers, which includes algorithms to diagnose DSM-IV disorders in children and adolescents . ParticiThe Beck Depression Inventory II (BDI-II)  measuresPrimary outcome measures include symptoms of depression as well as anxiety, because the intervention is intended to reduce symptoms of these two internalizing disorders. The questionnaires used for assessing these primary outcome measures, are also used as screening measures.The Centre for Epidemiological Studies Depression scale (CES-D)  is a widThe Hospital Anxiety and Depression Scale (HADS)  is an exSecondary outcome measures include quality of life, symptoms of social anxiety, and cost-effectiveness.The Pediatric Quality of Life Inventory 4.0 (PedsQL) is a self-administered paper-and-pencil questionnaire designed to assess quality of life in children and adolescents . It inclThe Social Anxiety Scale for Adolescents (SAS-A)  is one oThe Trimbos and iMTA questionnaire on Costs associated with Psychiatric Illness (TiC-P)  is used Predictors that might distinguish adolescents who benefit from the intervention, include demographic variables, motivation, treatment credibility and expectancy, externalizing behaviour, perceived social support from significant others, substance use, the experience of life events, physical activity, the quality of the therapeutic alliance, and satisfaction.A self-designed demographic questionnaire is used to collect participants' demographic information. This instrument consists of 15 questions concerning nationality, ethnic origin, living situation, and education.A self-designed questionnaire is used to assess participants' willingness to spend time on the intervention. The instrument consists of 5 questions rated on a 5-point Likert scale ranging from \"I totally disagree\" to \"I totally agree\".The Credibility/Expectancy Questionnaire (CEQ)  assesses\u03b1 = .57, and 10 items on aggressive behaviour, \u03b1 = .75. This short version of the YSR externalizing scale has an alpha of .79. Good reliability and validity estimates of the YSR have been documented [The Youth Self Report (YSR)  is a 101The Social Support Scale for Adolescents (SSSA)  is a 24-Adolescents are asked to respond to two questions about (1) how often they had consumed alcohol in the past 4 weeks, and (2) the number of occasions on which seven or more drinks in a row were consumed in the past 4 weeks. Answers are rated on a 6-point scale .Smoking behaviour is assessed with the question \"Have you ever smoked even part of a cigarette?\" Current smokers are those who mark the response \"yes, I now smoke cigarettes\". Non-smokers are those who mark any other response option, ranging from \"No, I've never smoked even part of a cigarette\" to \"Yes, I used to smoke at least once a week, but I quit\". Daily smoking is assessed with the question \"how much on average do you smoke per day?\" Response options range from 0 (less than one cigarette per day) to 6 (more than 30 cigarettes per day).Drug use is measured by asking participants to indicate how often, if ever, they have used soft drugs in the last twelve months. This question is also posed for using hard drugs. Responses range from 0 (never) to 13 (40 times or more).Adolescents complete a 12-item short form of the Life Event Questionnaire , which iPhysical activity is measured with the Godin-Shephard questionnaire . This quThe Working Alliance Inventory (WAI) is a measure of the quality of the therapeutic alliance between the client and therapist. The original 36 items of this self-report questionnaire are rated on a 7-point Likert scale and measure three distinct factors of the therapeutic relationship: the therapeutic bond, task agreement, and agreement on therapeutic goals. Good psychometric properties have been found . For thiThe 8-item Client Satisfaction Questionnaire (CSQ-8) is a one-dimensional instrument to assess global patient satisfaction . This shTo test whether the basic components of the intervention mediate the effects of the treatment on changes in depressive and anxiety symptoms, questionnaires including problem-solving skills, worrying, mastery, and self-esteem are administered.The Coping Inventory for Stressful Situations (CISS)  is a 48-The tendency of adolescents to engage in excessive, generalized, and uncontrollable worry is assessed with the Penn State Worry Questionnaire for Children (PSWQ-C) . The PSWPerceived control is assessed with the Mastery Scale . The sevSelf-esteem is measured with the Rosenberg Self-Esteem Scale (RSES) , a widelplus. With this method, it is possible to identify distinct groups of individuals, differing in the initial level and course of a specific behaviour, through the empirical identification of developmental trajectories [Intention-to-treat and completer analyses will be performed. Overall, treatment efficacy will be assessed with linear mixed modelling analysis using SPSS. For analyzing mediating variables and for the identification of subgroups in the sample, general growth mixture modelling will be applied, using M-ectories . This teectories .This study compares a preventive problem-solving guided self-help intervention through the Internet with a wait-list control group and aims to provide insight into the efficacy of the Internet-based intervention for adolescents. A secondary objective is to examine how the intervention works and for whom. A discussion of specific strengths and limitations of this study follows below.First of all, a strength of this study is that it is a practice-based project and both research aims relate to important matters in the treatment of adolescents with symptoms of depression and anxiety. There is a lack of studies on the efficacy of preventive self-help interventions for adolescents with emotional problems, which limits the evidence base for this treatment method. Simultaneously, insight into the questions as to which subgroups respond differently to the intervention and why and how the intervention led to change is scarce. Mechanisms of change are rarely studied in child and adolescent therapy, though the study of mechanisms of treatment can serve as a basis for maximizing treatment effects and ensuring that critical features are generalized to clinical practice . ResultsA strength of our intervention in particular is that it is offered through the Internet; it constitutes a self-help format, and may be used in adolescents with different types of comorbid problems. This is especially salient since a large group of untreated adolescents can therefore be reached.A strong aspect of the design of this study is the number of measurements. Six measurements are used, making it possible to analyze the role of potential mediating variables in predicting intervention effects and the development of different kind of symptoms over time.Another advantage of this study concerns the possibility to compare results with studies using clinical samples. Though subjects are included on the basis of self-rating instruments - as the intervention is intended to be applicable and accessible for a broad population with self-reported mild to moderate depressive and anxiety symptoms - information about whether subjects meet criteria for Major Depression, Dysthymia, Panic, Agoraphobia, Social phobia, and Generalized Anxiety Disorder is assessed. The standardized diagnostic interview is not used at posttest, however, so this study does not examine whether the intervention is actually capable of reducing the incidence of cases of depression and anxiety as defined by diagnostic criteria. When using a diagnostic interview both at baseline and follow-up, large numbers of subjects are needed to yield sufficient statistical power to be able to show significant effects on incidence . MoreoveA limitation of this study includes the relatively small sample size, making it difficult to draw firm conclusions about the moderation and mediation research questions. As our trial is primarily focused on determining whether the Internet intervention is a feasible and effective preventive intervention for adolescents with subsyndromal anxiety and depression, power is only calculated for our primary outcome measures. With regard to moderating and mediating variables or the effectiveness of our intervention for specific subgroups, our study is of an explorative nature, which will permit us with enough power to detect rather robust effects, while other less prominent associations may be more difficult to discern.Another limitation and expected problem constitutes refusals to participate in this study. Due to ethical considerations, only adolescents who are willing to ask for their parents' consent to participate in the current trial can be included. However, adolescents would often prefer to participate without parental consent. Negative parent-child relationships were also found to be related to depression in adolescence , suggestIn conclusion, many adolescents report symptoms of depression and anxiety but do not seek help in regular healthcare. This study aims to contribute to the evidence-based preventive treatment of emotional problems in adolescents by investigating problem-solving self-help therapy via Internet.The authors declare that they have no competing interests.PC and HMK obtained funding for the study. All authors contributed to the design of the study and the adaptation of the Internet-based PST intervention. WH coordinates the recruitment of participants and data collection during the study. JS and WH supervise the Problem-Solving Therapy. WH wrote the manuscript. All authors contributed to the further writing of the manuscript. All authors read and approved the final manuscript.", "texts": ["Even though depression and anxiety are highly prevalent in adolescence, youngsters are not inclined to seek help in regular healthcare. Therapy through the Internet, however, has been found to appeal strongly to young people. The main aim of the present study is to examine the efficacy of preventive Internet-based guided self-help problem-solving therapy with adolescents reporting depressive and anxiety symptoms. A secondary objective is to test potential mediating and moderating variables in order to gain insight into how the intervention works and for whom it works best.This study is a randomized controlled trial with an intervention condition group and a wait-list control group. The intervention condition group receives Internet-based self-help problem-solving therapy. Support is provided by a professional and delivered through email. Participants in the wait-list control group receive the intervention four months later. The study population consists of adolescents (12-18-year-olds) from the general population who report mild to moderate depressive and/or anxiety symptoms and are willing to complete a self-help course. Primary outcomes are symptoms of depression and anxiety. Secondary outcomes are quality of life, social anxiety, and cost-effectiveness. The following variables are examined for their moderating role: demographics, motivation, treatment credibility and expectancy, externalizing behaviour, perceived social support from parents and friends, substance use, the experience of important life events, physical activity, the quality of the therapeutic alliance, and satisfaction. Mediator variables include problem-solving skills, worrying, mastery, and self-esteem. Data are collected at baseline and at 3 weeks, 5 weeks, 4 months, 8 months, and 12 months after baseline. Both intention-to-treat and completer analyses will be conducted.This study evaluates the efficacy and mechanisms of Internet-based problem-solving therapy for adolescents. If Internet-based problem-solving therapy is shown to reduce depressive and anxiety symptoms in adolescents, the implication is to implement the intervention in clinical practice. Strengths and limitations of the study are discussed.Netherlands Trial Register NTR1322 Depression and anxiety disorders are the most prevalent mental disorders in adolescence, with lifetime prevalences between 17% and 28% by the age of 18 . FurtherDespite the high incidence of common mental health problems in adolescence, teenagers rarely seek professional help for their emotional problems through regular healthcare services. The Internet, however, offers the possibility to access this large group of untreated adolescents for adequate care: it has low threshold acceptability, is used frequently by young people, and reduces objections like lack of willingness to talk to a stranger about personal problems and fear of stigma . A recenFor adults, preventive self-help interventions have been offered through the Internet and proven to be effective in reducing symptoms of depression and anxiety e.g., -21). Sel. Sel21])Most web-based self-help interventions for psychological problems have been developed for treating (symptoms of) specific disorders like depression or a specific anxiety disorder. Face-to-face problem-solving therapy (PST), on the other hand, has been found to be effective in a variety of problem areas ,26. A neWhile Internet-based self-help is effective in adults, it is still unknown whether these interventions also work for adolescents. Also, little is known with regard to the mechanisms underlying change in this form of treatment and potential predictors of treatment effect. For the current study, the Dutch Internet-based PST intervention  was adapIn the present study, we examine the effects of an Internet-based guided self-help intervention (PST) for adolescents reporting mild to moderate symptoms of depression and/or anxiety compared to a wait-list control group. Potential moderating and mediating variables are investigated in order to identify predictors of treatment effect and to evaluate potential underlying mechanisms of change. Moderating variables are explored, i.e., demographics, motivation, treatment credibility and expectancy, externalizing behaviour, peer and parental perceived social support, substance use, the experience of life events, physical activity, the working alliance between participant and coach, and satisfaction. Problem-solving abilities, mastery, self-esteem and ruminative responses are investigated for their possible mediating effect.This study is a randomized controlled trial with two groups: the Internet-based self-help intervention group (PST) and a wait-list control group (WL). The study protocol has been approved by the Medical Ethics Committee of the VU University Medical Center.Adolescents (12 to 18-year-olds) with mild to moderate depressive and/or anxiety symptoms who are willing to participate in a self-help course are eligible for this study. Inclusion criteria are: sufficient knowledge of the Dutch language, access to Internet, and having an email address. Exclusion criteria are: absence of parental permission, already receiving treatment for mental health problems, the presence of severe depressive symptoms , severe anxiety symptoms , and/or prominent suicide ideation .Participants are recruited through banners and advertisements on the Internet, advertisements in magazines, referral by school-doctors, through brochures and posters in schools, and through information to parents who are treated in mental health care institutions for anxiety and depression. When signing in on the website, subjects receive a brochure and an informed consent form by email. In the brochure, information about the study's procedure and intervention is provided, and requirements for participation and parental consent are carefully explained. After application by the adolescent via email, parents receive a brochure and informed consent form by post. After receiving signed informed consent from both child and parents, participants receive an email with a link to the baseline questionnaire. Subjects with a score of 41 or higher on the CES-D are excluded. They receive a telephone call in which they are advised to consult their general practitioner. Their parents are also informed by telephone. The same procedure is followed in cases of a score of 15 or higher on the anxiety subscale of the HADS and/or a score of 2 or higher on the BDI-II suicide item. Eligible adolescents are randomized to either the intervention or the wait-list control condition, and are informed about the randomization outcome by email. Their parents also receive this email. Depression and anxiety subscales of the National Institute of Mental Health Diagnostic Interview Schedule for Children (NIMH-DISC IV) are subsequently conducted by telephone. Within two weeks after the baseline measurements, the intervention starts. Assessments take place during the treatment period, at treatment termination, and 4, 8, and 12 months after the start of the intervention. Figure Participants are randomly assigned to either the intervention or a waiting list. Randomization will take place at an individual level after the baseline measurement and one week before the start of the intervention. An independent researcher will make the allocation schedule with a computerized random number generator. The random allocation list will be generated in random permuted blocks of variable size . The randomization outcome per participant will be revealed to the primary investigator after the baseline measurement. In this manner, the investigator can give some background information  to the designated coach guiding the intervention participant through the course. Though the researcher has knowledge of participants' group assignment after the baseline measure, all other measures consist of automated online questionnaires and so there will be no contact here between participants and the primary researcher at all. Adolescents agree to participate before randomization and without knowing which group they will be allocated to. Received baseline questionnaires are numbered in order of arrival.The sample size is based on the expected difference (Cohen's d = .50) between the intervention group and the wait-list control group at post-test, on the primary outcome variables, i.e., depressive and anxiety symptoms. Based on an alpha of .05 and a power of .80 in a two-tailed test, we need 63 subjects in each condition. Because Internet interventions tend to result in relatively high dropout rates of up to 40%, we aim for 210 participants. The expected effect size and dropout rate are derived from our experiences with an earlier study on the proposed intervention in adults . High drThe PST intervention is a Dutch adaptation of SET . It has PST in this study consists of several steps and takes five weeks, with one lesson a week. In the first lesson, subjects make a list of what is most important in their lives  and a list of their current worries and problems. Having listed their problems, participants subsequently divide these into three categories: (a) unimportant problems (problems unrelated to the things that matter to them), (b) important problems which can be solved, and (c) important problems which cannot be solved . In the following weeks, participants can adapt their \"important things\" and \"problem\" lists while they learn to deal with the three types of problem introduced in the first lesson.In lesson 2, subjects are taught the focal component of the intervention which is a specific six-step problem-solving procedure for structurally resolving important problems which can be solved. In the first step of this procedure, participants need to describe their problem. The next steps involve (2) writing down all possible solutions you can think of, (3) choosing the best solution, (4) describing how the solution will be carried out , (5) carrying out your plan of the solution, and (6) checking whether the problem is resolved. Participants practice with this six-step PST procedure from lesson 2 onwards; all other material and exercises only play a supporting role.Lesson 3 deals with problems unrelated to things which are important, by proposing different strategies to eliminate negative thoughts and enhance positive thoughts. Strategies to eliminate negative thoughts concern (a) establishing one or two 15-minutes sessions a day for thinking about a problem (b) forcing yourself to immediately stop negative thoughts when they pop up, and (c) distracting yourself when ruminating, e.g., by calling a friend or engaging in sports. Two exercises for positive thinking are proposed; these are (a) thinking about three things which gave you a good feeling that day, and doing this every night before going to sleep, and (b) writing as many positive thoughts  as possible on small cards, and then pulling one of these out regularly.In lesson 4 - about important problems which cannot be solved -, participants are told that there are no rules for coping with a major event, but that it usually helps not to avoid negative emotions. Avoidance can be reduced by writing about your feelings, talking about your experiences with people that you feel close to, or by getting in touch with fellow-sufferers. Links to Dutch websites for specific types of problems are provided on the website.During the fifth and last lesson, subjects look at their \"problem list\" again and are encouraged to identify the most important problem area - the problem most closely related to their feelings of depression and/or anxiety. They subsequently write down their goals concerning this problem for the long term. What are your goals for the next four months, and what are you going to do when encountering difficulties? Subjects also look at their \"important things list\" and are encouraged to think about actions they can undertake in order to reach these important things. Other exercises include making plans of how to deal with upcoming important life events which might make you feel low, and making a plan of what to do when encountering signals of depression or anxiety again; i.e., what steps they can take in order to prevent a relapse.After the last lesson the website provides some general tips for counteracting depressed and anxious feelings, and phone numbers of professional mental health institutes are supplied. Figure Subjects in the intervention group receive email support from employees of the Prevention and Intervention group of a mental health care institute in Amsterdam and the first two authors of this paper. Support is directed at guiding the participant through the intervention. This is done by sending an email if the coach does not receive participants' exercises at the end of the lesson and by commenting on the exercises made by participants. Comments include thanking the participant for sending and completing the exercises, compliments about exercises done well, asking for clarification when necessary, answering questions participants might have about the exercises, and giving tips when finding that the participant did not fully understand the exercise . When participants send their assignments to their coach, they receive feedback within three working days. Support is not intended to give direct or individual advice on how to cope with depression, anxiety or other problems. Although performing the course with email support is strongly recommended, participants are permitted to complete the intervention without support.Participants on the waiting list receive no intervention or support, only a link to a website with general information about depression and anxiety. They can commence the intervention four months after the intervention group starts the course.Screening measures, primary outcome measures, secondary outcome measures, measures of clinical predictors, and measures of mediating variables can be distinguished in this study. The instruments include a diagnostic interview by phone and self-report questionnaires which are filled in by participants through the Internet.A structured diagnostic interview and self-report questionnaires including suicidal ideation, depression, and anxiety are administered as screening measures in this study.The Diagnostic Interview Schedule for Children (version NIMH DISC-4.0) is a reliable and valid structured diagnostic interview designed for lay interviewers, which includes algorithms to diagnose DSM-IV disorders in children and adolescents . ParticiThe Beck Depression Inventory II (BDI-II)  measuresPrimary outcome measures include symptoms of depression as well as anxiety, because the intervention is intended to reduce symptoms of these two internalizing disorders. The questionnaires used for assessing these primary outcome measures, are also used as screening measures.The Centre for Epidemiological Studies Depression scale (CES-D)  is a widThe Hospital Anxiety and Depression Scale (HADS)  is an exSecondary outcome measures include quality of life, symptoms of social anxiety, and cost-effectiveness.The Pediatric Quality of Life Inventory 4.0 (PedsQL) is a self-administered paper-and-pencil questionnaire designed to assess quality of life in children and adolescents . It inclThe Social Anxiety Scale for Adolescents (SAS-A)  is one oThe Trimbos and iMTA questionnaire on Costs associated with Psychiatric Illness (TiC-P)  is used Predictors that might distinguish adolescents who benefit from the intervention, include demographic variables, motivation, treatment credibility and expectancy, externalizing behaviour, perceived social support from significant others, substance use, the experience of life events, physical activity, the quality of the therapeutic alliance, and satisfaction.A self-designed demographic questionnaire is used to collect participants' demographic information. This instrument consists of 15 questions concerning nationality, ethnic origin, living situation, and education.A self-designed questionnaire is used to assess participants' willingness to spend time on the intervention. The instrument consists of 5 questions rated on a 5-point Likert scale ranging from \"I totally disagree\" to \"I totally agree\".The Credibility/Expectancy Questionnaire (CEQ)  assesses\u03b1 = .57, and 10 items on aggressive behaviour, \u03b1 = .75. This short version of the YSR externalizing scale has an alpha of .79. Good reliability and validity estimates of the YSR have been documented [The Youth Self Report (YSR)  is a 101The Social Support Scale for Adolescents (SSSA)  is a 24-Adolescents are asked to respond to two questions about (1) how often they had consumed alcohol in the past 4 weeks, and (2) the number of occasions on which seven or more drinks in a row were consumed in the past 4 weeks. Answers are rated on a 6-point scale .Smoking behaviour is assessed with the question \"Have you ever smoked even part of a cigarette?\" Current smokers are those who mark the response \"yes, I now smoke cigarettes\". Non-smokers are those who mark any other response option, ranging from \"No, I've never smoked even part of a cigarette\" to \"Yes, I used to smoke at least once a week, but I quit\". Daily smoking is assessed with the question \"how much on average do you smoke per day?\" Response options range from 0 (less than one cigarette per day) to 6 (more than 30 cigarettes per day).Drug use is measured by asking participants to indicate how often, if ever, they have used soft drugs in the last twelve months. This question is also posed for using hard drugs. Responses range from 0 (never) to 13 (40 times or more).Adolescents complete a 12-item short form of the Life Event Questionnaire , which iPhysical activity is measured with the Godin-Shephard questionnaire . This quThe Working Alliance Inventory (WAI) is a measure of the quality of the therapeutic alliance between the client and therapist. The original 36 items of this self-report questionnaire are rated on a 7-point Likert scale and measure three distinct factors of the therapeutic relationship: the therapeutic bond, task agreement, and agreement on therapeutic goals. Good psychometric properties have been found . For thiThe 8-item Client Satisfaction Questionnaire (CSQ-8) is a one-dimensional instrument to assess global patient satisfaction . This shTo test whether the basic components of the intervention mediate the effects of the treatment on changes in depressive and anxiety symptoms, questionnaires including problem-solving skills, worrying, mastery, and self-esteem are administered.The Coping Inventory for Stressful Situations (CISS)  is a 48-The tendency of adolescents to engage in excessive, generalized, and uncontrollable worry is assessed with the Penn State Worry Questionnaire for Children (PSWQ-C) . The PSWPerceived control is assessed with the Mastery Scale . The sevSelf-esteem is measured with the Rosenberg Self-Esteem Scale (RSES) , a widelplus. With this method, it is possible to identify distinct groups of individuals, differing in the initial level and course of a specific behaviour, through the empirical identification of developmental trajectories [Intention-to-treat and completer analyses will be performed. Overall, treatment efficacy will be assessed with linear mixed modelling analysis using SPSS. For analyzing mediating variables and for the identification of subgroups in the sample, general growth mixture modelling will be applied, using M-ectories . This teectories .This study compares a preventive problem-solving guided self-help intervention through the Internet with a wait-list control group and aims to provide insight into the efficacy of the Internet-based intervention for adolescents. A secondary objective is to examine how the intervention works and for whom. A discussion of specific strengths and limitations of this study follows below.First of all, a strength of this study is that it is a practice-based project and both research aims relate to important matters in the treatment of adolescents with symptoms of depression and anxiety. There is a lack of studies on the efficacy of preventive self-help interventions for adolescents with emotional problems, which limits the evidence base for this treatment method. Simultaneously, insight into the questions as to which subgroups respond differently to the intervention and why and how the intervention led to change is scarce. Mechanisms of change are rarely studied in child and adolescent therapy, though the study of mechanisms of treatment can serve as a basis for maximizing treatment effects and ensuring that critical features are generalized to clinical practice . ResultsA strength of our intervention in particular is that it is offered through the Internet; it constitutes a self-help format, and may be used in adolescents with different types of comorbid problems. This is especially salient since a large group of untreated adolescents can therefore be reached.A strong aspect of the design of this study is the number of measurements. Six measurements are used, making it possible to analyze the role of potential mediating variables in predicting intervention effects and the development of different kind of symptoms over time.Another advantage of this study concerns the possibility to compare results with studies using clinical samples. Though subjects are included on the basis of self-rating instruments - as the intervention is intended to be applicable and accessible for a broad population with self-reported mild to moderate depressive and anxiety symptoms - information about whether subjects meet criteria for Major Depression, Dysthymia, Panic, Agoraphobia, Social phobia, and Generalized Anxiety Disorder is assessed. The standardized diagnostic interview is not used at posttest, however, so this study does not examine whether the intervention is actually capable of reducing the incidence of cases of depression and anxiety as defined by diagnostic criteria. When using a diagnostic interview both at baseline and follow-up, large numbers of subjects are needed to yield sufficient statistical power to be able to show significant effects on incidence . MoreoveA limitation of this study includes the relatively small sample size, making it difficult to draw firm conclusions about the moderation and mediation research questions. As our trial is primarily focused on determining whether the Internet intervention is a feasible and effective preventive intervention for adolescents with subsyndromal anxiety and depression, power is only calculated for our primary outcome measures. With regard to moderating and mediating variables or the effectiveness of our intervention for specific subgroups, our study is of an explorative nature, which will permit us with enough power to detect rather robust effects, while other less prominent associations may be more difficult to discern.Another limitation and expected problem constitutes refusals to participate in this study. Due to ethical considerations, only adolescents who are willing to ask for their parents' consent to participate in the current trial can be included. However, adolescents would often prefer to participate without parental consent. Negative parent-child relationships were also found to be related to depression in adolescence , suggestIn conclusion, many adolescents report symptoms of depression and anxiety but do not seek help in regular healthcare. This study aims to contribute to the evidence-based preventive treatment of emotional problems in adolescents by investigating problem-solving self-help therapy via Internet.The authors declare that they have no competing interests.PC and HMK obtained funding for the study. All authors contributed to the design of the study and the adaptation of the Internet-based PST intervention. WH coordinates the recruitment of participants and data collection during the study. JS and WH supervise the Problem-Solving Therapy. WH wrote the manuscript. All authors contributed to the further writing of the manuscript. All authors read and approved the final manuscript."]}
{"representative": "Postpartum weight retention may contribute to the development of obesity. We studied whether individual counselling on diet and physical activity from 2 to 10 months postpartum has positive effects on diet and leisure time physical activity and increases the proportion of primiparas returning to their pre-pregnancy weight.A controlled trial including ninety-two postpartum primiparas was conducted in three intervention and three control child health clinics in primary health care in Finland. The intervention included individual counselling on diet and physical activity during five routine visits to a public health nurse; the controls received the usual care.In total, 50% of the intervention group and 30% of the control group returned to their pre-pregnancy weight (weight retention \u2264 0 kg) by 10 months postpartum (p = 0.06). The confounder-adjusted odds ratio for returning to pre-pregnancy weight was 3.89  for the intervention group compared with the controls. The mean proportion of high-fibre bread  increased by 16.1% (95% CI 4.3\u201327.9) by 10 months postpartum in the intervention group compared with the controls when adjusted for confounders (p = 0.008). No significant differences were observed in changes in leisure time physical activity between the groups.The intervention increased the proportion of primiparas returning to pre-pregnancy weight and the proportion of high-fibre bread in their diet. Larger randomized controlled trials are needed to show whether counselling can improve dietary and leisure time physical activity habits in postpartum women and also to confirm the results concerning the effect on reducing postpartum weight retention.Current Controlled Trials ISRCTN21512277 In Finlormation . Postparormation . The aveormation .Excessive gestational weight gain is the primary risk factor for retaining weight in the postpartum period -6. OtherRelatively few weight loss interventions have been conducted among postpartum women. Only two of these studies aimed primarily to reduce postpartum weight retention ,13, whilThe aim of the study was to investigate whether individual counselling on diet and physical activity after pregnancy has positive effects on diet and leisure time physical activity (LTPA) and increases the proportion of primiparas who return to their pre-pregnancy weight by 10 months postpartum. This study is a part of a pilot study testing the feasibility of the study protocol for a larger study also including pregnant women .The postpartum women were recruited through the child health care system, which is available to all families with children in every municipality in Finland and is funded by public tax revenue. Almost all (98%) children attend these public child health clinics (CC) for regular check-ups, as concluded from the proportion of children who are immunized according to immunization schedules under the age of two . The stuAll PHNs from the intervention clinics and the control clinics participated in the study (n = 8 and n = 6 respectively). Before the intervention began, the PHNs of the intervention clinics were trained in applying the counselling procedures, data collection and other study arrangements by the research group . The PHNs were also asked to practise the counselling between the training sessions with at least one client not participating in the study. The experiences were shared in small group sessions. The PHNs of the control clinics were trained for data collection and other study arrangements . All PHNs received a handbook in which the tasks for each research visit were explained and summarized. The researchers visited the clinics monthly during the intervention.All participants were primiparas. The exclusion criteria were age under 18 years, type 1 or type 2 diabetes mellitus, twin pregnancy, physical disability that prevents exercising, otherwise problematic pregnancy, substance abuse, treatment or clinical history of any psychiatric illness, inadequate language skills in Finnish and intention to change residence within three months. Between August 2004 and January 2005, the PHNs approached all postpartum primiparas in these six CCs and assessed their eligibility for the study either on their visit to the participant's home after delivery or on the first visit to the CC. All eligible women were asked to participate in the study. In total, 53 women in the intervention clinics and 39 women in the control clinics gave informed consent to participation , suggesting that the PHNs merely gave general advice on diet and physical activity rather than implementing actual counselling. During this study, the PHNs of the control clinics continued their usual physical activity and dietary counselling practices.The PHNs had brief discussions with the participants about pre-pregnancy body weight at the child's 2-month visit to the CC. If the pre-pregnancy weight was lower than the current weight, the PHN encouraged the participant to try to return to that weight with the help of dietary and physical activity objectives (see below) during the study period. Extensive weight loss programmes, however, were not recommended.The physical activity counselling consisted of one primary counselling session  at the 2-month visit and four booster sessions  at the 3, 5, 6 and 10 month visits. The counselling was implemented using the model of Laitakari and Asikainen , which iAccording to the physical activity recommendations for health  and fitnAs a part of the LTPA plan, the participant had an option to attend supervised group exercise sessions held once a week for 45\u201360 min at a location close to each intervention clinic. The group exercise included both endurance and muscular training and it was developed specifically for postpartum women.Based on dietary recommendations ,28, a suThe dietary counselling consisted of one primary counselling session  at the 3-month visit and three booster sessions  at the 5, 6 and 10 month visits. The model of Laitakari and Asikainen  was alsoThe main outcome for postpartum weight retention was the proportion of women returning to their pre-pregnancy weight (weight retention \u22640 kg) by 10 months postpartum. The dietary outcomes were changes in meal pattern , overall intake of vegetables, fruit and berries (portions/d), use of high-fibre bread  and intake of high-sugar snacks (portions/d). The physical activity outcome was the change in the weekly METmin of LTPA.Body weight was measured in light clothing and without shoes at every CC visit related to the study. The scales were calibrated to the reference scale within \u00b1 0.5 kg at the beginning and at the end of the study. Additionally, waist circumference was measured at these visits. Data on gestational weight development was obtained from the maternity card. Pre-pregnancy weight and height were self-reported.The baseline questionnaire including questions on background , dietary intake and LTPA was completed before the child's 2-month visit. The first LTPA and the dietary follow-up questionnaires were completed at the 5-month visit and the second follow-up questionnaires at the 10-month visit. These questionnaires were returned to the PHN, who checked that they were properly filled in. Information on dietary intake was obtained using a 57-item food frequency questionnaire that was a simplified version of the food frequency questionnaire used in the Health 2000 study in Finland . The bas2-test for categorised variables. Differences in the duration of exclusive and partial breastfeeding were tested using non-parametric Mann-Whitney U test, since these variables were not normally distributed. As there were missing values in the duration of breastfeeding for 11 women, an indicator variable  together with the continuous breastfeeding variables was used in the multivariable analyses to prevent the loss of data. These background variables were used, when necessary, as covariates in the multivariable analyses regardless the statistical significance of the baseline differences.To test the baseline differences in background characteristics Table , t-test 2-test. The confounder-adjusted analysis of the proportions of women returning to pre-pregnancy weight, and retaining a maximum of 2 or 5 kg were done by using a logistic regression model. Analysis of covariance (ANCOVA) with confounding variables as covariates was used to test the between-group differences in average weight retention and waist circumference at 10 months postpartum, also changes in the dietary outcomes from 2 to 5 and to 10 months postpartum. As the weekly METmin were not normally distributed, they were converted into logarithms. The between-group differences of the log-transformed METmin variable at 5 and 10 months postpartum were analysed using ANCOVA of repeated measures. All statistical tests were two-sided and p < 0.05 was used as the level of statistical significance.The unadjusted differences between the groups in the proportions of women who returned to their pre-pregnancy weight were tested by \u03c7Figure In the intervention group, 43 (90%) women participated in all physical activity counselling sessions and 45 (94%) women in all dietary counselling sessions. All 48 women participated in the primary physical activity and dietary counselling sessions. Five women missed one physical activity booster session, three women missed one dietary booster session and three women missed the discussion about returning to pre-pregnancy weight. On average, the women participated in 4.9 of the five physical activity counselling sessions and in 3.9 of the four dietary counselling sessions. The average participation rate in the group exercise sessions was 50.7 % (sd 28.5) of the sessions available for each woman.The differences in the background characteristics were not statistically significant between the groups Table . There wFigure The proportion of high-fibre bread of total weekly amount of bread increased in the intervention group compared to the control group when adjusted for confounders Table . The meaThe unadjusted mean weekly METmin during leisure time were 2 328 (SD 1 308) in the intervention group and 2 061 (SD 975) in the control group before pregnancy (the baseline). At 10 months postpartum the values were 1 906 (SD 970) and 2 051 (SD 1 249) respectively. There were no statistically significant differences between the groups in changes in the weekly METmin from baseline to 5 or 10 months postpartum when adjusted for baseline weekly METmin, age, education, gestational weight gain and BMI at 2 months postpartum.This study aimed at reducing postpartum weight retention in primiparas by counselling them on diet and physical activity during five of the child's routine visits to a CC. We observed that a higher proportion of the women in the intervention group than in the control group returned to their pre-pregnancy weight by 10 months postpartum, when adjusted for confounders. However, among those women who did not return to their pre-pregnancy weight, the intervention group retained more weight than the control group on average. Therefore, the average weight retention was not lower in the intervention group than in the control group.The changes in dietary habits were modest, since only the mean proportion of high-fibre bread of total weekly amount of bread increased by 15\u201316 %-unit in the intervention group compared to controls from baseline to 5 and 10 months postpartum. This change corresponds e.g. to replacing one slice of low-fibre bread by one slice of high-fibre bread for every sixth slice consumed. No between-group differences were found in the intake of vegetables, fruit and berries or high-sugar snacks in favour of the intervention group. As the proportion of women having breakfast and a hot meal every day was already high at baseline, there was little potential to promote these habits by counselling. The counselling did not have an effect on the total amount of LTPA, possibly at least partly due to the fairly high level of LTPA at baseline (before pregnancy) or difficulties in arranging more time for LTPA in the new life situation.The results of this study mostly concur with the two earlier interventions aimed at reducing postpartum weight retention ,13. In bHowever, this study primarily piloted the study protocol for a larger study, which contributes to some limitations of this study. Firstly, the CCs were not randomized, which may have increased the baseline differences between the groups. The intervention group had slightly higher mean gestational weight gain and BMI, which are risk factors for high postpartum weight retention -6. AlthoIt is not clear why a higher proportion in the intervention group than in the control group returned to their pre-pregnancy weight as the effects of the intervention on dietary and LTPA habits were so minor. This discrepancy could be related to difficulties in assessing one's diet and LTPA accurately or to the limitations of our questionnaires not validated among postpartum women. The LTPA questionnaire may not have been sensitive enough in measuring changes, particularly in everyday light-intensity LTPA, which contributes significantly to the total energy expenditure. In addition, the intervention group may have decreased their total energy intake as a result of the dietary counselling, but it could not be measured by the semi-quantitative food frequency questionnaire. On the other hand, neither Leermakers et al.  nor O'ToTo our knowledge, this was the first study conducted in a primary healthy care setting aiming to reduce postpartum weight retention by dietary and physical activity counselling. The PHNs implemented the five counselling sessions on the child's routine visits to the CC and therefore the participation rate at the counselling sessions was very high. The counselling focused on promoting healthy dietary and physical activity habits. Individual recommendations for energy intake and expenditure, and thereby for energy deficit , were not applied, because it would have been too complicated, especially as the time allocated for the counselling was short. It is possible that the women would have needed even more counselling or support to improve their dietary or physical activity habits. The time span between the last two booster sessions (4 months) may have been too long to motivate the women to adhere to the dietary and LTPA plans without support from their PHN. On the other hand, increasing the number of counselling sessions may not be feasible, since the time resources of the PHNs are limited and the main focus on the visits is on the infant's health and growth. It is possible that the presence of infants interfered with the counselling.The need for postpartum counselling and support for healthy diet and weight management has been emphasised in several papers -36. In pIntegrating individual dietary and physical activity counselling for mothers into the routine visits to CCs increased the proportion of postpartum primiparas returning to their pre-pregnancy weight, although it did not have an effect on the average weight retention. Larger randomized controlled trials are needed to show whether counselling can improve dietary and physical activity habits in postpartum women and also to confirm the results concerning the effect of counselling on reducing postpartum weight retention.The author(s) declare that they have no competing interests.TIK: study design, intervention protocols , acquisition of data, analysis and interpretation of data, and preparation of manuscript.MP: study design, intervention protocols, statistical methodology, analysis and interpretation of data, and preparation of manuscript.MA: study design, intervention protocols , acquisition of data, interpretation of data, and preparation of manuscript.MF: study design, intervention protocols, interpretation of data and preparation of manuscript.EW: study design, interpretation of data, and preparation of manuscript.RL: principal researcher, obtained funding, study concept and design, intervention protocols, interpretation of data, and preparation of manuscript.All authors read and approved the final manuscript.", "texts": ["Postpartum weight retention may contribute to the development of obesity. We studied whether individual counselling on diet and physical activity from 2 to 10 months postpartum has positive effects on diet and leisure time physical activity and increases the proportion of primiparas returning to their pre-pregnancy weight.A controlled trial including ninety-two postpartum primiparas was conducted in three intervention and three control child health clinics in primary health care in Finland. The intervention included individual counselling on diet and physical activity during five routine visits to a public health nurse; the controls received the usual care.In total, 50% of the intervention group and 30% of the control group returned to their pre-pregnancy weight (weight retention \u2264 0 kg) by 10 months postpartum (p = 0.06). The confounder-adjusted odds ratio for returning to pre-pregnancy weight was 3.89  for the intervention group compared with the controls. The mean proportion of high-fibre bread  increased by 16.1% (95% CI 4.3\u201327.9) by 10 months postpartum in the intervention group compared with the controls when adjusted for confounders (p = 0.008). No significant differences were observed in changes in leisure time physical activity between the groups.The intervention increased the proportion of primiparas returning to pre-pregnancy weight and the proportion of high-fibre bread in their diet. Larger randomized controlled trials are needed to show whether counselling can improve dietary and leisure time physical activity habits in postpartum women and also to confirm the results concerning the effect on reducing postpartum weight retention.Current Controlled Trials ISRCTN21512277 In Finlormation . Postparormation . The aveormation .Excessive gestational weight gain is the primary risk factor for retaining weight in the postpartum period -6. OtherRelatively few weight loss interventions have been conducted among postpartum women. Only two of these studies aimed primarily to reduce postpartum weight retention ,13, whilThe aim of the study was to investigate whether individual counselling on diet and physical activity after pregnancy has positive effects on diet and leisure time physical activity (LTPA) and increases the proportion of primiparas who return to their pre-pregnancy weight by 10 months postpartum. This study is a part of a pilot study testing the feasibility of the study protocol for a larger study also including pregnant women .The postpartum women were recruited through the child health care system, which is available to all families with children in every municipality in Finland and is funded by public tax revenue. Almost all (98%) children attend these public child health clinics (CC) for regular check-ups, as concluded from the proportion of children who are immunized according to immunization schedules under the age of two . The stuAll PHNs from the intervention clinics and the control clinics participated in the study (n = 8 and n = 6 respectively). Before the intervention began, the PHNs of the intervention clinics were trained in applying the counselling procedures, data collection and other study arrangements by the research group . The PHNs were also asked to practise the counselling between the training sessions with at least one client not participating in the study. The experiences were shared in small group sessions. The PHNs of the control clinics were trained for data collection and other study arrangements . All PHNs received a handbook in which the tasks for each research visit were explained and summarized. The researchers visited the clinics monthly during the intervention.All participants were primiparas. The exclusion criteria were age under 18 years, type 1 or type 2 diabetes mellitus, twin pregnancy, physical disability that prevents exercising, otherwise problematic pregnancy, substance abuse, treatment or clinical history of any psychiatric illness, inadequate language skills in Finnish and intention to change residence within three months. Between August 2004 and January 2005, the PHNs approached all postpartum primiparas in these six CCs and assessed their eligibility for the study either on their visit to the participant's home after delivery or on the first visit to the CC. All eligible women were asked to participate in the study. In total, 53 women in the intervention clinics and 39 women in the control clinics gave informed consent to participation , suggesting that the PHNs merely gave general advice on diet and physical activity rather than implementing actual counselling. During this study, the PHNs of the control clinics continued their usual physical activity and dietary counselling practices.The PHNs had brief discussions with the participants about pre-pregnancy body weight at the child's 2-month visit to the CC. If the pre-pregnancy weight was lower than the current weight, the PHN encouraged the participant to try to return to that weight with the help of dietary and physical activity objectives (see below) during the study period. Extensive weight loss programmes, however, were not recommended.The physical activity counselling consisted of one primary counselling session  at the 2-month visit and four booster sessions  at the 3, 5, 6 and 10 month visits. The counselling was implemented using the model of Laitakari and Asikainen , which iAccording to the physical activity recommendations for health  and fitnAs a part of the LTPA plan, the participant had an option to attend supervised group exercise sessions held once a week for 45\u201360 min at a location close to each intervention clinic. The group exercise included both endurance and muscular training and it was developed specifically for postpartum women.Based on dietary recommendations ,28, a suThe dietary counselling consisted of one primary counselling session  at the 3-month visit and three booster sessions  at the 5, 6 and 10 month visits. The model of Laitakari and Asikainen  was alsoThe main outcome for postpartum weight retention was the proportion of women returning to their pre-pregnancy weight (weight retention \u22640 kg) by 10 months postpartum. The dietary outcomes were changes in meal pattern , overall intake of vegetables, fruit and berries (portions/d), use of high-fibre bread  and intake of high-sugar snacks (portions/d). The physical activity outcome was the change in the weekly METmin of LTPA.Body weight was measured in light clothing and without shoes at every CC visit related to the study. The scales were calibrated to the reference scale within \u00b1 0.5 kg at the beginning and at the end of the study. Additionally, waist circumference was measured at these visits. Data on gestational weight development was obtained from the maternity card. Pre-pregnancy weight and height were self-reported.The baseline questionnaire including questions on background , dietary intake and LTPA was completed before the child's 2-month visit. The first LTPA and the dietary follow-up questionnaires were completed at the 5-month visit and the second follow-up questionnaires at the 10-month visit. These questionnaires were returned to the PHN, who checked that they were properly filled in. Information on dietary intake was obtained using a 57-item food frequency questionnaire that was a simplified version of the food frequency questionnaire used in the Health 2000 study in Finland . The bas2-test for categorised variables. Differences in the duration of exclusive and partial breastfeeding were tested using non-parametric Mann-Whitney U test, since these variables were not normally distributed. As there were missing values in the duration of breastfeeding for 11 women, an indicator variable  together with the continuous breastfeeding variables was used in the multivariable analyses to prevent the loss of data. These background variables were used, when necessary, as covariates in the multivariable analyses regardless the statistical significance of the baseline differences.To test the baseline differences in background characteristics Table , t-test 2-test. The confounder-adjusted analysis of the proportions of women returning to pre-pregnancy weight, and retaining a maximum of 2 or 5 kg were done by using a logistic regression model. Analysis of covariance (ANCOVA) with confounding variables as covariates was used to test the between-group differences in average weight retention and waist circumference at 10 months postpartum, also changes in the dietary outcomes from 2 to 5 and to 10 months postpartum. As the weekly METmin were not normally distributed, they were converted into logarithms. The between-group differences of the log-transformed METmin variable at 5 and 10 months postpartum were analysed using ANCOVA of repeated measures. All statistical tests were two-sided and p < 0.05 was used as the level of statistical significance.The unadjusted differences between the groups in the proportions of women who returned to their pre-pregnancy weight were tested by \u03c7Figure In the intervention group, 43 (90%) women participated in all physical activity counselling sessions and 45 (94%) women in all dietary counselling sessions. All 48 women participated in the primary physical activity and dietary counselling sessions. Five women missed one physical activity booster session, three women missed one dietary booster session and three women missed the discussion about returning to pre-pregnancy weight. On average, the women participated in 4.9 of the five physical activity counselling sessions and in 3.9 of the four dietary counselling sessions. The average participation rate in the group exercise sessions was 50.7 % (sd 28.5) of the sessions available for each woman.The differences in the background characteristics were not statistically significant between the groups Table . There wFigure The proportion of high-fibre bread of total weekly amount of bread increased in the intervention group compared to the control group when adjusted for confounders Table . The meaThe unadjusted mean weekly METmin during leisure time were 2 328 (SD 1 308) in the intervention group and 2 061 (SD 975) in the control group before pregnancy (the baseline). At 10 months postpartum the values were 1 906 (SD 970) and 2 051 (SD 1 249) respectively. There were no statistically significant differences between the groups in changes in the weekly METmin from baseline to 5 or 10 months postpartum when adjusted for baseline weekly METmin, age, education, gestational weight gain and BMI at 2 months postpartum.This study aimed at reducing postpartum weight retention in primiparas by counselling them on diet and physical activity during five of the child's routine visits to a CC. We observed that a higher proportion of the women in the intervention group than in the control group returned to their pre-pregnancy weight by 10 months postpartum, when adjusted for confounders. However, among those women who did not return to their pre-pregnancy weight, the intervention group retained more weight than the control group on average. Therefore, the average weight retention was not lower in the intervention group than in the control group.The changes in dietary habits were modest, since only the mean proportion of high-fibre bread of total weekly amount of bread increased by 15\u201316 %-unit in the intervention group compared to controls from baseline to 5 and 10 months postpartum. This change corresponds e.g. to replacing one slice of low-fibre bread by one slice of high-fibre bread for every sixth slice consumed. No between-group differences were found in the intake of vegetables, fruit and berries or high-sugar snacks in favour of the intervention group. As the proportion of women having breakfast and a hot meal every day was already high at baseline, there was little potential to promote these habits by counselling. The counselling did not have an effect on the total amount of LTPA, possibly at least partly due to the fairly high level of LTPA at baseline (before pregnancy) or difficulties in arranging more time for LTPA in the new life situation.The results of this study mostly concur with the two earlier interventions aimed at reducing postpartum weight retention ,13. In bHowever, this study primarily piloted the study protocol for a larger study, which contributes to some limitations of this study. Firstly, the CCs were not randomized, which may have increased the baseline differences between the groups. The intervention group had slightly higher mean gestational weight gain and BMI, which are risk factors for high postpartum weight retention -6. AlthoIt is not clear why a higher proportion in the intervention group than in the control group returned to their pre-pregnancy weight as the effects of the intervention on dietary and LTPA habits were so minor. This discrepancy could be related to difficulties in assessing one's diet and LTPA accurately or to the limitations of our questionnaires not validated among postpartum women. The LTPA questionnaire may not have been sensitive enough in measuring changes, particularly in everyday light-intensity LTPA, which contributes significantly to the total energy expenditure. In addition, the intervention group may have decreased their total energy intake as a result of the dietary counselling, but it could not be measured by the semi-quantitative food frequency questionnaire. On the other hand, neither Leermakers et al.  nor O'ToTo our knowledge, this was the first study conducted in a primary healthy care setting aiming to reduce postpartum weight retention by dietary and physical activity counselling. The PHNs implemented the five counselling sessions on the child's routine visits to the CC and therefore the participation rate at the counselling sessions was very high. The counselling focused on promoting healthy dietary and physical activity habits. Individual recommendations for energy intake and expenditure, and thereby for energy deficit , were not applied, because it would have been too complicated, especially as the time allocated for the counselling was short. It is possible that the women would have needed even more counselling or support to improve their dietary or physical activity habits. The time span between the last two booster sessions (4 months) may have been too long to motivate the women to adhere to the dietary and LTPA plans without support from their PHN. On the other hand, increasing the number of counselling sessions may not be feasible, since the time resources of the PHNs are limited and the main focus on the visits is on the infant's health and growth. It is possible that the presence of infants interfered with the counselling.The need for postpartum counselling and support for healthy diet and weight management has been emphasised in several papers -36. In pIntegrating individual dietary and physical activity counselling for mothers into the routine visits to CCs increased the proportion of postpartum primiparas returning to their pre-pregnancy weight, although it did not have an effect on the average weight retention. Larger randomized controlled trials are needed to show whether counselling can improve dietary and physical activity habits in postpartum women and also to confirm the results concerning the effect of counselling on reducing postpartum weight retention.The author(s) declare that they have no competing interests.TIK: study design, intervention protocols , acquisition of data, analysis and interpretation of data, and preparation of manuscript.MP: study design, intervention protocols, statistical methodology, analysis and interpretation of data, and preparation of manuscript.MA: study design, intervention protocols , acquisition of data, interpretation of data, and preparation of manuscript.MF: study design, intervention protocols, interpretation of data and preparation of manuscript.EW: study design, interpretation of data, and preparation of manuscript.RL: principal researcher, obtained funding, study concept and design, intervention protocols, interpretation of data, and preparation of manuscript.All authors read and approved the final manuscript."]}
{"representative": "We have previously reported that a one-year school-based exercise intervention program influences the accrual of bone mineral in pre-pubertal girls. This report aims to evaluate if also hip structure is affected, as geometry independent of bone mineral influences fracture risk.t-test between means and analyses of covariance (ANCOVA). Pearson's correlation test was used to evaluate associations between activity level and annual changes in FN. All children remained at Tanner stage 1 throughout the study.Fifty-three girls aged 7 \u2013 9 years were included in a curriculum-based exercise intervention program comprising 40 minutes of general physical activity per school day (200 minutes/week). Fifty healthy age-matched girls who participated in the general Swedish physical education curriculum (60 minutes/week) served as controls. The hip was scanned by dual X-ray absorptiometry (DXA) and the hip structural analysis (HSA) software was applied to evaluate bone mineral content (BMC), areal bone mineral density (aBMD), periosteal and endosteal diameter, cortical thickness, cross-sectional moment of inertia (CSMI), section modulus (Z) and cross-sectional area (CSA) of the femoral neck (FN). Annual changes were compared. Group comparisons were done by independent student's No between-group differences were found during the 12 months study period for changes in the FN variables. The total duration of exercise during the year was not correlated with the changes in the FN traits.Evaluated by the DXA technique and the HSA software, a general one-year school-based exercise program for 7\u20139-year-old pre-pubertal girls seems not to influence the structure of the hip. Physical activity during growth is associated with benefits in bone mineral accrual and possibly bone structure -4, a cliThe Malm\u00f6 Pediatric Osteoporosis Prevention (POP) study was conducted as a prospective controlled investigation of the impact of an exercise intervention on skeletal development in children from school start and onwards. The baseline measurements in the school, that was allocated as intervention school, were made before the intervention was initiated and the follow-up measurements one year later. Three neighboring control schools, allocated within the same city suburb, were evaluated in the same way, but the follow-up measurements of the control group were done in the same months but two years later. Due to lack of resources in our research laboratory, controls were re-measured first after two years. However, we accepted a two-year follow-up for the controls, because data in the literature imply that skeletal growth and accrual of bone mineral is linear in Tanner stage 1 and before the age of ten ,18-26. TThe four schools that were contacted agreed to participate. All four were located in the same part of the city in areas that were socio-economically similar; they were government funded; and allocation of pupils to the schools was done according to residential address. Before the intervention, they all used the Swedish standard curriculum for physical education (PE) to the same extent. After the four schools accepted participation, one of them was asked to be the intervention school and agreed to that. The intervention school modified its curriculum by increasing the number of PE classes; in other words, we did not choose a school that already had a high level of physical activity (PA) for its pupils. The other three schools were included as a control cohort. Furthermore, in order to ascertain whether there was any selection bias at baseline, we compared the girls who took part in the study with those who refused to participate. This was done by considering data on height, weight, and body mass index (BMI) obtained from the initial standard compulsory school health evaluation of first grade pupils. The drop-out analyses revealed that, based on data from the school records, there were no significant differences at baseline in height, weight, or BMI between girls who participated in the study and those who refused to take part ,9.In the intervention school, all 61 girls in grades 1 and 2 were invited to attend, and 55 agreed to participate (attendance rate 90%). We excluded one girl at baseline, because she was 11 months younger than the second-youngest girl. At follow up, one girl declined further participation. Therefore, a total of 53 girls with a mean age of 7.7 \u00b1 0.6 (mean \u00b1 SD), (range 6.5\u20138.7), years at baseline were included in the intervention group. Sixty-four volunteers participated at baseline as controls. At follow-up, 13 had moved out of the region or declined further participation, and we excluded one girl because she was being treated with growth hormone. Thus a total of 50 girls with a mean age of 7.9 \u00b1 0.6 (range 6.8\u20138.9) at baseline were included in the control group. All participants were healthy Caucasians who had no diseases and were not taking medications known to influence bone metabolism.The exercise intervention was initiated at the beginning of the school term after the baseline measurement. The program consisted of both indoor and outdoor physical activities that are ordinarily included in the PE curriculum in Swedish schools, such as running, jumping, climbing ropes, and playing a variety of ball games. The curriculum was supervised by the usual class teacher and was increased from 60 minutes per week to 200 minutes per week (40 minutes/day), thus no specific osteogenic training program was added. Furthermore, the teachers were instructed to vary the activities and sports, so that the children would not get bored by repetition. The aim was to minimize the number of dropouts, which has been reported to be fairly high during and after exercise intervention programs . The con\u00ae, Madison, WI) measurements the children were dressed in light clothes and no shoes. Paediatric software was used in all scans with children below 35 kg in weight. That is, the software was changed in some children between the different measurements. All standard image files of the proximal femur were analyzed by one technician, by use of the hip strength analysis (HSA) software. The software is provided by Lunar Instruments Corporation . Using this software the X-ray absorption data of the proximal femur is extracted from the output image data file and the bone mineral content  and areal bone mineral density  and its distribution within the FN calculated. First the operator has to manually define the center of the femoral head and place the FN axis as accurately as possible along the FN. Thereafter, the region of interest in the FN is placed in the proximal part of the FN, and finally the femoral shaft axis is defined centrally along the shaft. The software will then iteratively assess all cross sections in the FN region of interest and identify the plane with the least cross-sectional moment of inertia . CSMI is an estimate of the ability of the FN to withstand bending forces, and that value was calculated using the mass distribution derived from the absorption curve [2 = 0.96) [3) and cross-sectional area . The section modulus is also an estimate of the ability of the FN to withstand bending forces, and it was computed as CSMI divided by half the width of the FN. CSA is a measure of the resistance of the bone to axial forces, and it represents the area of mineral packed together in the defined cross section of the FN and is essentially proportional to the bone mineral content (BMC). In addition, endosteal diameter was estimated using the algorithm described by Thomas J. Beck [2 \u00d7 FN length), where r = FN mid-diameter/2, assuming the FN to be cylindrical [During the dual X-ray absorptiometry  . Automat J. Beck . Mean coindrical ,31.\u00ae phantom. The technicians in our research group performed all the measurements, and one technician conducted all software analyses. Total lean mass and total fat mass were estimated from the DXA total body scan. Body weight was measured to the nearest 0.1 kg using an electric scale, and height was determined to the nearest 0.5 cm using a wall-mounted measuring rod.The coefficient of variation (CV) was evaluated by duplicate measurements in 13 healthy children ages seven to fifteen (mean 10) years was found to be 1.4% for BMC, 1.6% for aBMD, 3.7% for total body fat mass, and 1.5% for total body lean mass. The CV values for the HSA analyses were 1.5% for FN periosteal diameter, 2.2% for FN CSA, and 6.2% for FN CSMI. The machine was calibrated daily with the LunarA questionnaire previously used in several studies but modified for pre-pubertal children ,33 was eInformed written consent was obtained from parents or guardians of participants prior to the study start. The study was approved by the Ethics Committee of Lund University , Sweden, and conducted according to the Helsinki Declaration of 2000. The Swedish Data Inspection Board approved both the data collection and database.t-test between means was used for group comparisons. Analyses of covariance (ANCOVA) were used to adjust for chronological age at baseline and increment in height and weight in the follow up evaluations to adjust any difference in growth. Pearson's correlation test was applied to correlate the total mean duration of physical activity, calculated as the mean of the total physical activity at baseline and at follow-up, with changes in the bone parameters during the study period. Statistical calculations were performed using Statistica\u00ae, version 6.1 (StatWin\u00ae). A p-value < 0.05 was defined as a statistically significant difference. With known annual growth in the evaluated parameters in Swedish children aged 7 years and with a significance level of p < 0.05 this study was powered to detect an annual difference in gain in BMC of 0.102 g/yrs, BMD of 0.019 g/cm2/yrs, vBMD of 0.011 g/cm3/yrs, neck length of 0.6 mm/yrs, periosteal width of 0.5 mm/yrs, CSA of 0.05 cm2/yrs, Z of 0.19 cm3/yrs, CSMI of 0.029 cm4/yrs, endosteal width of 0.5 mm/yrs and cortical thickness of 0.3 mm/yrs.Research has shown the technical problems when scanning small children based on inconsistency in limb positioning and location of the region of interest , we advoAs previously reported, the intervention group and the control group did not at baseline differ with regard to registered lifestyle factors or anthropometric parameters . After oThe mean values for the FN at baseline were 6.0% higher for aBMD (p = 0.04) and 7.0% higher for cortical thickness p = 0.02) in the intervention group as compared to the control group  and magnetic resonance imaging (MRI) ,42, as tThe technical limitations of the HSA technique must also be highlighted. Inconsistent positioning of the limb or placement of the region of interest results in errors ,13. A smIt is also well known that differences in fat in the marrow or the soft tissue above, below or around the bones may affect the DXA bone variables . HoweverA one-year moderately intense school based exercise intervention program in pre-pubertal girls seems not to influence the by the DXA technique and HSA software estimated FN structure. Further studies are required to determine if an exercise program exceeding one year, a program with a higher intensity of training and a program in early peri-pubertal girls could be beneficial for the FN structure.The author(s) declare that they have no competing interests.Study design: MK and PG; Data collection: CL, JB and SSL; Statistical analyses and hip strength analyses and writing of the paper: GA, HA and MK. All authors read and approved the final manuscriptThe pre-publication history for this paper can be accessed here:", "texts": ["We have previously reported that a one-year school-based exercise intervention program influences the accrual of bone mineral in pre-pubertal girls. This report aims to evaluate if also hip structure is affected, as geometry independent of bone mineral influences fracture risk.t-test between means and analyses of covariance (ANCOVA). Pearson's correlation test was used to evaluate associations between activity level and annual changes in FN. All children remained at Tanner stage 1 throughout the study.Fifty-three girls aged 7 \u2013 9 years were included in a curriculum-based exercise intervention program comprising 40 minutes of general physical activity per school day (200 minutes/week). Fifty healthy age-matched girls who participated in the general Swedish physical education curriculum (60 minutes/week) served as controls. The hip was scanned by dual X-ray absorptiometry (DXA) and the hip structural analysis (HSA) software was applied to evaluate bone mineral content (BMC), areal bone mineral density (aBMD), periosteal and endosteal diameter, cortical thickness, cross-sectional moment of inertia (CSMI), section modulus (Z) and cross-sectional area (CSA) of the femoral neck (FN). Annual changes were compared. Group comparisons were done by independent student's No between-group differences were found during the 12 months study period for changes in the FN variables. The total duration of exercise during the year was not correlated with the changes in the FN traits.Evaluated by the DXA technique and the HSA software, a general one-year school-based exercise program for 7\u20139-year-old pre-pubertal girls seems not to influence the structure of the hip. Physical activity during growth is associated with benefits in bone mineral accrual and possibly bone structure -4, a cliThe Malm\u00f6 Pediatric Osteoporosis Prevention (POP) study was conducted as a prospective controlled investigation of the impact of an exercise intervention on skeletal development in children from school start and onwards. The baseline measurements in the school, that was allocated as intervention school, were made before the intervention was initiated and the follow-up measurements one year later. Three neighboring control schools, allocated within the same city suburb, were evaluated in the same way, but the follow-up measurements of the control group were done in the same months but two years later. Due to lack of resources in our research laboratory, controls were re-measured first after two years. However, we accepted a two-year follow-up for the controls, because data in the literature imply that skeletal growth and accrual of bone mineral is linear in Tanner stage 1 and before the age of ten ,18-26. TThe four schools that were contacted agreed to participate. All four were located in the same part of the city in areas that were socio-economically similar; they were government funded; and allocation of pupils to the schools was done according to residential address. Before the intervention, they all used the Swedish standard curriculum for physical education (PE) to the same extent. After the four schools accepted participation, one of them was asked to be the intervention school and agreed to that. The intervention school modified its curriculum by increasing the number of PE classes; in other words, we did not choose a school that already had a high level of physical activity (PA) for its pupils. The other three schools were included as a control cohort. Furthermore, in order to ascertain whether there was any selection bias at baseline, we compared the girls who took part in the study with those who refused to participate. This was done by considering data on height, weight, and body mass index (BMI) obtained from the initial standard compulsory school health evaluation of first grade pupils. The drop-out analyses revealed that, based on data from the school records, there were no significant differences at baseline in height, weight, or BMI between girls who participated in the study and those who refused to take part ,9.In the intervention school, all 61 girls in grades 1 and 2 were invited to attend, and 55 agreed to participate (attendance rate 90%). We excluded one girl at baseline, because she was 11 months younger than the second-youngest girl. At follow up, one girl declined further participation. Therefore, a total of 53 girls with a mean age of 7.7 \u00b1 0.6 (mean \u00b1 SD), (range 6.5\u20138.7), years at baseline were included in the intervention group. Sixty-four volunteers participated at baseline as controls. At follow-up, 13 had moved out of the region or declined further participation, and we excluded one girl because she was being treated with growth hormone. Thus a total of 50 girls with a mean age of 7.9 \u00b1 0.6 (range 6.8\u20138.9) at baseline were included in the control group. All participants were healthy Caucasians who had no diseases and were not taking medications known to influence bone metabolism.The exercise intervention was initiated at the beginning of the school term after the baseline measurement. The program consisted of both indoor and outdoor physical activities that are ordinarily included in the PE curriculum in Swedish schools, such as running, jumping, climbing ropes, and playing a variety of ball games. The curriculum was supervised by the usual class teacher and was increased from 60 minutes per week to 200 minutes per week (40 minutes/day), thus no specific osteogenic training program was added. Furthermore, the teachers were instructed to vary the activities and sports, so that the children would not get bored by repetition. The aim was to minimize the number of dropouts, which has been reported to be fairly high during and after exercise intervention programs . The con\u00ae, Madison, WI) measurements the children were dressed in light clothes and no shoes. Paediatric software was used in all scans with children below 35 kg in weight. That is, the software was changed in some children between the different measurements. All standard image files of the proximal femur were analyzed by one technician, by use of the hip strength analysis (HSA) software. The software is provided by Lunar Instruments Corporation . Using this software the X-ray absorption data of the proximal femur is extracted from the output image data file and the bone mineral content  and areal bone mineral density  and its distribution within the FN calculated. First the operator has to manually define the center of the femoral head and place the FN axis as accurately as possible along the FN. Thereafter, the region of interest in the FN is placed in the proximal part of the FN, and finally the femoral shaft axis is defined centrally along the shaft. The software will then iteratively assess all cross sections in the FN region of interest and identify the plane with the least cross-sectional moment of inertia . CSMI is an estimate of the ability of the FN to withstand bending forces, and that value was calculated using the mass distribution derived from the absorption curve [2 = 0.96) [3) and cross-sectional area . The section modulus is also an estimate of the ability of the FN to withstand bending forces, and it was computed as CSMI divided by half the width of the FN. CSA is a measure of the resistance of the bone to axial forces, and it represents the area of mineral packed together in the defined cross section of the FN and is essentially proportional to the bone mineral content (BMC). In addition, endosteal diameter was estimated using the algorithm described by Thomas J. Beck [2 \u00d7 FN length), where r = FN mid-diameter/2, assuming the FN to be cylindrical [During the dual X-ray absorptiometry  . Automat J. Beck . Mean coindrical ,31.\u00ae phantom. The technicians in our research group performed all the measurements, and one technician conducted all software analyses. Total lean mass and total fat mass were estimated from the DXA total body scan. Body weight was measured to the nearest 0.1 kg using an electric scale, and height was determined to the nearest 0.5 cm using a wall-mounted measuring rod.The coefficient of variation (CV) was evaluated by duplicate measurements in 13 healthy children ages seven to fifteen (mean 10) years was found to be 1.4% for BMC, 1.6% for aBMD, 3.7% for total body fat mass, and 1.5% for total body lean mass. The CV values for the HSA analyses were 1.5% for FN periosteal diameter, 2.2% for FN CSA, and 6.2% for FN CSMI. The machine was calibrated daily with the LunarA questionnaire previously used in several studies but modified for pre-pubertal children ,33 was eInformed written consent was obtained from parents or guardians of participants prior to the study start. The study was approved by the Ethics Committee of Lund University , Sweden, and conducted according to the Helsinki Declaration of 2000. The Swedish Data Inspection Board approved both the data collection and database.t-test between means was used for group comparisons. Analyses of covariance (ANCOVA) were used to adjust for chronological age at baseline and increment in height and weight in the follow up evaluations to adjust any difference in growth. Pearson's correlation test was applied to correlate the total mean duration of physical activity, calculated as the mean of the total physical activity at baseline and at follow-up, with changes in the bone parameters during the study period. Statistical calculations were performed using Statistica\u00ae, version 6.1 (StatWin\u00ae). A p-value < 0.05 was defined as a statistically significant difference. With known annual growth in the evaluated parameters in Swedish children aged 7 years and with a significance level of p < 0.05 this study was powered to detect an annual difference in gain in BMC of 0.102 g/yrs, BMD of 0.019 g/cm2/yrs, vBMD of 0.011 g/cm3/yrs, neck length of 0.6 mm/yrs, periosteal width of 0.5 mm/yrs, CSA of 0.05 cm2/yrs, Z of 0.19 cm3/yrs, CSMI of 0.029 cm4/yrs, endosteal width of 0.5 mm/yrs and cortical thickness of 0.3 mm/yrs.Research has shown the technical problems when scanning small children based on inconsistency in limb positioning and location of the region of interest , we advoAs previously reported, the intervention group and the control group did not at baseline differ with regard to registered lifestyle factors or anthropometric parameters . After oThe mean values for the FN at baseline were 6.0% higher for aBMD (p = 0.04) and 7.0% higher for cortical thickness p = 0.02) in the intervention group as compared to the control group  and magnetic resonance imaging (MRI) ,42, as tThe technical limitations of the HSA technique must also be highlighted. Inconsistent positioning of the limb or placement of the region of interest results in errors ,13. A smIt is also well known that differences in fat in the marrow or the soft tissue above, below or around the bones may affect the DXA bone variables . HoweverA one-year moderately intense school based exercise intervention program in pre-pubertal girls seems not to influence the by the DXA technique and HSA software estimated FN structure. Further studies are required to determine if an exercise program exceeding one year, a program with a higher intensity of training and a program in early peri-pubertal girls could be beneficial for the FN structure.The author(s) declare that they have no competing interests.Study design: MK and PG; Data collection: CL, JB and SSL; Statistical analyses and hip strength analyses and writing of the paper: GA, HA and MK. All authors read and approved the final manuscriptThe pre-publication history for this paper can be accessed here:"]}
{"representative": "Persons with cerebral palsy (CP) are at risk for developing an inactive lifestyle and often have poor fitness levels, which may lead to secondary health complications and diminished participation and quality of life. However, persons with CP also tend not to receive structural treatment to improve physical activity and fitness in adolescence, which is precisely the period when adult physical activity patterns are established.We aim to include 60 adolescents and young adults (16-24 years) with spastic CP. Participants will be randomly assigned to an intervention group or a control group . The intervention will last 6 months and consist of three parts; 1) counselling on daily physical activity; 2) physical fitness training; and 3) sports advice. To evaluate the effectiveness of the intervention, all participants will be measured before, during, directly after, and at 6 months following the intervention period. Primary outcome measures will be: 1) physical activity level, which will be measured objectively with an accelerometry-based activity monitor during 72 h and subjectively with the Physical Activity Scale for Individuals with Physical Disabilities; 2) aerobic fitness, which will be measured with a maximal ramp test on a bicycle or armcrank ergometer and a 6-minute walking or wheelchair test; 3) neuromuscular fitness, which will be measured with handheld dynamometry; and 4 body composition, which will be determined by measuring body mass, height, waist circumference, fat mass and lipid profile.This paper outlines the design, methodology and intervention of a multicenter randomized controlled trial (LEARN 2 MOVE 16-24) aimed at examining the effectiveness of an intervention that is intended to permanently increase physical activity levels and improve fitness levels of adolescents and young adults with CP by achieving a behavioral change toward a more active lifestyle.Dutch Trial Register; NTR1785 Cerebral palsy (CP) occurs in 1.5 to 3.0 of 1000 live births and is the most common cause of physical disability in pediatric rehabilitation medicine  which caParticipation in regular physical activity (PA) provides psychological and physiological benefits in adolescents . In addiPersons develop their adult PA lifestyle in adolescence ,16. TherThe LEARN 2 MOVE 16-24 research project aims to evaluate the effectiveness and underlying working mechanisms on the short and long term of an Active Lifestyle and Sports Participation (ALSP) intervention. It is hypothesized that persons following the ALSP intervention will experience increased PA and improved physical fitness in both the short term and the long term (maintenance of effects) as the primary goal of the intervention is to achieve a behavioral change toward a more active lifestyle. The present paper describes the research design, methodology and intervention of the LEARN 2 MOVE 16-24 research project -25.Multicenter approval was granted by the Erasmus MC Medical Ethics Committee, The Netherlands. Local approval was granted by all participating centers.The study has a multicenter randomized controlled design. The experimental group will receive the ALSP intervention. The control group will receive no intervention to improve PA and fitness, which is current policy. Erasmus MC (Rotterdam), Rijndam Rehabilitation Center (Rotterdam), VU Medical Center (Amsterdam), Rehabilitation Center Amsterdam (Amsterdam), Rehabilitation Center De Hoogstraat (Utrecht) and Sophia Rehabilitation (Den Haag/Delft) will participate in this study.This study has a single-blind research design; all measurements will be performed by assessors who are blind for group allocation and who have no involvement in the recruitment, randomization procedure or intervention.The ALSP intervention and the research measurements will be performed at each participant's house and at two university medical centers and four rehabilitation centers from which all participants will be recruited.At least 50 participants are required to detect a difference of 30 minutes a day in PA level between the control and experimental group, with a power of 0.8 and an alpha of 0.05. To allow for dropouts, we aim to recruit at least 60 participants. This calculation is based on data from previous research conducted by our research group ,14.Adolescents and young adults with spastic unilateral or bilateral CP are eligible for inclusion if they meet each of the following criteria\u2022 Age 16 - 24 years\u2022 Gross Motor Functioning Classification System (GMFCS ) level IIndividuals will be excluded if they meet any of the following criteria\u2022 Disabilities other than CP that affect PA or fitness level\u2022 Contraindication for  exercise\u2022 Severe cognitive disorders and insufficient comprehension of the Dutch language that preclude understanding the purpose of the project and its testing methods\u2022 PA level at baseline exceeds the mean PA level + 2 SD of a CP populationEach participating center will compile a list of its patients aged 16 - 24 years and diagnosed with CP. All patients will be checked on inclusion and exclusion criteria by their rehabilitation physician. An information letter and invitation to participate was sent to eligible participants. A second letter was sent 3 weeks later to non-responders.After baseline measurement, participants will be stratified according to their GMFCS level to obtain an equal distribution of gross motor functioning between the two groups. Within each stratum and for each participating center, participants will be randomly allocated (1:1) to the experimental or control group.The ALSP intervention lasts 6 months and was developed for adolescents and young adults with physical disabilities . It aims1. Counselling on daily PA2. Physical fitness training3. Sports adviceCounselling on daily PA is the main component of the intervention and consists of six individual counselling sessions over a period of 6 months with a PA counsellor  who serves as a 'personal coach'. During these counselling sessions, participants will receive individual PA advice which primarily focuses on PA in daily life, and not necessarily on sports. The counselling sessions on daily PA are based on Motivational Interviewing (MI) which is defined as a directive, client-centered counselling style for eliciting behavioral changes by helping clients to explore and resolve ambivalence . TechniqPhysical fitness training will consist of 12 weekly supervised sessions and 12 home sessions. These training sessions of approximately one hour consist of aerobic endurance, aerobic interval and strength training. Over these 12 weeks, aerobic exercise duration and aerobic intensity (as determined by the Karvonen formula ) are graSports advice includes sports counselling and sport-specific training. Sports counselling is based on the Rehabilitation & Sports Program ,22. DuriThe International Classification of Functioning, Disability and Health (ICF) model provides a unified language and framework for the description of health and health-related states . This moTo objectively measure the level of daily PA the VitaMove (VM) system  will be applied. This system is based on long-term ambulatory monitoring of signals from body-fixed accelerometers. This system consists of 3 to 5 recorders  duration of dynamic activities as a percentage of a 24-hour period; (2) number of transitions ; (3) intensity of activities: (3a) mean motility ); (3b) motility during walking; (3c) motility during wheelchair-driving; and (4) distribution of continuous dynamic activity periods .The following data will be analyzed from these measurements:   will be 2peak in ml\u00b7min-1 and ml\u00b7kg-1\u00b7min-1). Subjective strain will be measured immediately after the final stage by the Borg Scale for Rating of Perceived Exertion [The aerobic capacity will be measured during a maximal ramp protocol. This test will be performed on an electronically braked cycle ergometer or electronically braked armcrank ergometer depending on the main mode of ambulation during daily life, as this elicits the highest oxygen uptake . The tesExertion . DetermiExertion .The 6 minute walking test  will be Muscle strength will be measured with a hand-held dynamometer  using the \"break\" testing method. The strength of the hip flexors, hip abductors and knee extensors will be measured in individuals whose main mode of ambulation is walking. The strength of shoulder abductors and elbow extensors will be measured in non-ambulant individuals. The applicator of the dynamometer is held against the distal part of the limb segment, and participants will be asked to build up their maximum force against it. When maximum is reached the examiner applies sufficient resistance to overcome the force exerted by the participant. Both the left and right side will be measured. The lever arm from the joint to the dynamometer will be kept constant by marking the position of the dynamometer on each participant's leg. Each trial lasts approximately 4 seconds, and three repetitions will be performed with 1 minute of rest in between. The average value of the three repetitions will be analyzed.-2) will be calculated from height and body mass. Waist circumference (cm) will be measured mid-way between the lowest rib and the iliac crest while standing. Waist circumference will be measured in a sitting position in persons using a wheelchair. Thickness of four skin folds  will be measured twice on the left side of the body with a Harpenden calliper . The mean of the two measurements will be used as representative. Percentage body fat will be predicted from skin fold thickness according to the method of Durnin and Womersley [Height will be measured barefoot in a standing position. In case of joint contractures, measurements will be performed from joint to joint in a lying position. Body mass of ambulatory participants will be obtained while standing barefoot on a scale and of non-ambulatory participants while sitting on an electronic scale. Body mass index , selectTo evaluate the change in PA level and physical fitness, as well as the secondary outcome measures, multilevel regression analyses will be applied, because these analyses allow for missing values. Another advantage of these analyses is that patient data can be clustered within the participating centers. For all multilevel analyses, MLwiN  software will be used.This paper outlines the design, methodology and intervention of a multicenter randomized controlled trial that examines the effectiveness of an intervention that aims to achieve a permanent increase in PA level and improve the fitness level of adolescents and young adults with CP by promoting a behavioral change toward a more active lifestyle. The results of this trial are expected to be presented in 2012.The authors declare that they have no competing interests.The work presented here was a collaboration between all the authors. JS and RB drafted the manuscript. JS, RB and MR have made substantial contributions to the conceptualization and the design of the study and defined the research theme. JM, WS, HR, EL and HS have made valuable contributions to the conceptualization and the design of the study and contributed to the manuscript by revising it critically for important intellectual content. All authors have seen and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2431/10/79/prepub", "texts": ["Persons with cerebral palsy (CP) are at risk for developing an inactive lifestyle and often have poor fitness levels, which may lead to secondary health complications and diminished participation and quality of life. However, persons with CP also tend not to receive structural treatment to improve physical activity and fitness in adolescence, which is precisely the period when adult physical activity patterns are established.We aim to include 60 adolescents and young adults (16-24 years) with spastic CP. Participants will be randomly assigned to an intervention group or a control group . The intervention will last 6 months and consist of three parts; 1) counselling on daily physical activity; 2) physical fitness training; and 3) sports advice. To evaluate the effectiveness of the intervention, all participants will be measured before, during, directly after, and at 6 months following the intervention period. Primary outcome measures will be: 1) physical activity level, which will be measured objectively with an accelerometry-based activity monitor during 72 h and subjectively with the Physical Activity Scale for Individuals with Physical Disabilities; 2) aerobic fitness, which will be measured with a maximal ramp test on a bicycle or armcrank ergometer and a 6-minute walking or wheelchair test; 3) neuromuscular fitness, which will be measured with handheld dynamometry; and 4 body composition, which will be determined by measuring body mass, height, waist circumference, fat mass and lipid profile.This paper outlines the design, methodology and intervention of a multicenter randomized controlled trial (LEARN 2 MOVE 16-24) aimed at examining the effectiveness of an intervention that is intended to permanently increase physical activity levels and improve fitness levels of adolescents and young adults with CP by achieving a behavioral change toward a more active lifestyle.Dutch Trial Register; NTR1785 Cerebral palsy (CP) occurs in 1.5 to 3.0 of 1000 live births and is the most common cause of physical disability in pediatric rehabilitation medicine  which caParticipation in regular physical activity (PA) provides psychological and physiological benefits in adolescents . In addiPersons develop their adult PA lifestyle in adolescence ,16. TherThe LEARN 2 MOVE 16-24 research project aims to evaluate the effectiveness and underlying working mechanisms on the short and long term of an Active Lifestyle and Sports Participation (ALSP) intervention. It is hypothesized that persons following the ALSP intervention will experience increased PA and improved physical fitness in both the short term and the long term (maintenance of effects) as the primary goal of the intervention is to achieve a behavioral change toward a more active lifestyle. The present paper describes the research design, methodology and intervention of the LEARN 2 MOVE 16-24 research project -25.Multicenter approval was granted by the Erasmus MC Medical Ethics Committee, The Netherlands. Local approval was granted by all participating centers.The study has a multicenter randomized controlled design. The experimental group will receive the ALSP intervention. The control group will receive no intervention to improve PA and fitness, which is current policy. Erasmus MC (Rotterdam), Rijndam Rehabilitation Center (Rotterdam), VU Medical Center (Amsterdam), Rehabilitation Center Amsterdam (Amsterdam), Rehabilitation Center De Hoogstraat (Utrecht) and Sophia Rehabilitation (Den Haag/Delft) will participate in this study.This study has a single-blind research design; all measurements will be performed by assessors who are blind for group allocation and who have no involvement in the recruitment, randomization procedure or intervention.The ALSP intervention and the research measurements will be performed at each participant's house and at two university medical centers and four rehabilitation centers from which all participants will be recruited.At least 50 participants are required to detect a difference of 30 minutes a day in PA level between the control and experimental group, with a power of 0.8 and an alpha of 0.05. To allow for dropouts, we aim to recruit at least 60 participants. This calculation is based on data from previous research conducted by our research group ,14.Adolescents and young adults with spastic unilateral or bilateral CP are eligible for inclusion if they meet each of the following criteria\u2022 Age 16 - 24 years\u2022 Gross Motor Functioning Classification System (GMFCS ) level IIndividuals will be excluded if they meet any of the following criteria\u2022 Disabilities other than CP that affect PA or fitness level\u2022 Contraindication for  exercise\u2022 Severe cognitive disorders and insufficient comprehension of the Dutch language that preclude understanding the purpose of the project and its testing methods\u2022 PA level at baseline exceeds the mean PA level + 2 SD of a CP populationEach participating center will compile a list of its patients aged 16 - 24 years and diagnosed with CP. All patients will be checked on inclusion and exclusion criteria by their rehabilitation physician. An information letter and invitation to participate was sent to eligible participants. A second letter was sent 3 weeks later to non-responders.After baseline measurement, participants will be stratified according to their GMFCS level to obtain an equal distribution of gross motor functioning between the two groups. Within each stratum and for each participating center, participants will be randomly allocated (1:1) to the experimental or control group.The ALSP intervention lasts 6 months and was developed for adolescents and young adults with physical disabilities . It aims1. Counselling on daily PA2. Physical fitness training3. Sports adviceCounselling on daily PA is the main component of the intervention and consists of six individual counselling sessions over a period of 6 months with a PA counsellor  who serves as a 'personal coach'. During these counselling sessions, participants will receive individual PA advice which primarily focuses on PA in daily life, and not necessarily on sports. The counselling sessions on daily PA are based on Motivational Interviewing (MI) which is defined as a directive, client-centered counselling style for eliciting behavioral changes by helping clients to explore and resolve ambivalence . TechniqPhysical fitness training will consist of 12 weekly supervised sessions and 12 home sessions. These training sessions of approximately one hour consist of aerobic endurance, aerobic interval and strength training. Over these 12 weeks, aerobic exercise duration and aerobic intensity (as determined by the Karvonen formula ) are graSports advice includes sports counselling and sport-specific training. Sports counselling is based on the Rehabilitation & Sports Program ,22. DuriThe International Classification of Functioning, Disability and Health (ICF) model provides a unified language and framework for the description of health and health-related states . This moTo objectively measure the level of daily PA the VitaMove (VM) system  will be applied. This system is based on long-term ambulatory monitoring of signals from body-fixed accelerometers. This system consists of 3 to 5 recorders  duration of dynamic activities as a percentage of a 24-hour period; (2) number of transitions ; (3) intensity of activities: (3a) mean motility ); (3b) motility during walking; (3c) motility during wheelchair-driving; and (4) distribution of continuous dynamic activity periods .The following data will be analyzed from these measurements:   will be 2peak in ml\u00b7min-1 and ml\u00b7kg-1\u00b7min-1). Subjective strain will be measured immediately after the final stage by the Borg Scale for Rating of Perceived Exertion [The aerobic capacity will be measured during a maximal ramp protocol. This test will be performed on an electronically braked cycle ergometer or electronically braked armcrank ergometer depending on the main mode of ambulation during daily life, as this elicits the highest oxygen uptake . The tesExertion . DetermiExertion .The 6 minute walking test  will be Muscle strength will be measured with a hand-held dynamometer  using the \"break\" testing method. The strength of the hip flexors, hip abductors and knee extensors will be measured in individuals whose main mode of ambulation is walking. The strength of shoulder abductors and elbow extensors will be measured in non-ambulant individuals. The applicator of the dynamometer is held against the distal part of the limb segment, and participants will be asked to build up their maximum force against it. When maximum is reached the examiner applies sufficient resistance to overcome the force exerted by the participant. Both the left and right side will be measured. The lever arm from the joint to the dynamometer will be kept constant by marking the position of the dynamometer on each participant's leg. Each trial lasts approximately 4 seconds, and three repetitions will be performed with 1 minute of rest in between. The average value of the three repetitions will be analyzed.-2) will be calculated from height and body mass. Waist circumference (cm) will be measured mid-way between the lowest rib and the iliac crest while standing. Waist circumference will be measured in a sitting position in persons using a wheelchair. Thickness of four skin folds  will be measured twice on the left side of the body with a Harpenden calliper . The mean of the two measurements will be used as representative. Percentage body fat will be predicted from skin fold thickness according to the method of Durnin and Womersley [Height will be measured barefoot in a standing position. In case of joint contractures, measurements will be performed from joint to joint in a lying position. Body mass of ambulatory participants will be obtained while standing barefoot on a scale and of non-ambulatory participants while sitting on an electronic scale. Body mass index , selectTo evaluate the change in PA level and physical fitness, as well as the secondary outcome measures, multilevel regression analyses will be applied, because these analyses allow for missing values. Another advantage of these analyses is that patient data can be clustered within the participating centers. For all multilevel analyses, MLwiN  software will be used.This paper outlines the design, methodology and intervention of a multicenter randomized controlled trial that examines the effectiveness of an intervention that aims to achieve a permanent increase in PA level and improve the fitness level of adolescents and young adults with CP by promoting a behavioral change toward a more active lifestyle. The results of this trial are expected to be presented in 2012.The authors declare that they have no competing interests.The work presented here was a collaboration between all the authors. JS and RB drafted the manuscript. JS, RB and MR have made substantial contributions to the conceptualization and the design of the study and defined the research theme. JM, WS, HR, EL and HS have made valuable contributions to the conceptualization and the design of the study and contributed to the manuscript by revising it critically for important intellectual content. All authors have seen and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2431/10/79/prepub"]}
{"representative": "In menopausal women, the term quality-of-life incorporates its physical symptoms such as hot flushes, night sweats and vaginal mucosa dryness. We set out this study in order to evaluate the effect of education on the quality-of-life and the improvement of health standards in menopausal women.Women are one of the most important parts of the family and society, and community health is dependent on provision of the needs of this group. Menopause is one of the most critical stages of life among women. One of the aims of health services for all of the people in the 21Sixty-two women aged 44\u201355 referring to and academic outpatient clinic in Shiraz were selected by simple random sampling, and allocated in two groups. Data was collected using a modified Hildich questionnaire on quality-of-life in menopause stage. Quality-of-life of the subjects  were evaluated prior to and 3 months after educational intervention.P = 0.001). A significant difference was seen between groups in terms of changing quality-of-life after intervention (P = 0.001).Mean quality-of-life score in study and control groups, prior to education, was 81.7 and 74.8; changing to 75.3 and 75.8, respectively three months after intervention. The study group showed a significant improvement in their quality-of-life (Appropriate training to menopausal women improves their quality-of-life and promotes their health. Women are among the most important part of any society and family, and community health provision is dependent on the fulfillment of different health needs. On the other hand, menopause is one of the most critical stages of women health. Definingst century is to improve quality-of-life. in Shiraz was evaluated during 2007\u20132008. The Medical Research Ethics Committee of Shiraz University of Medical Sciences approved the study. All of participants signed informed consent and they were assured of guarantees of confidentiality and anonymity during and after the study.From power calculation, by means of a prior pilot study, 31 women in each treatment group with at least 25 completing the study were needed for 95% power to detect at least 5% difference in the quality-of-life.Patients considered for this study were healthy, premenopause or menopause women. InclusioScores for quality-of-life in the study and control groups were evaluated and compared in two stages  both between and within the groups as changes before and after education.In order to collect data on quality-of-life, we used a questionnaire containing 29 questions about quality-of-life in menopause designed by Hilditch. The qualet al. study (13). Using Likert scoring method, each question could be scored by 6 points . Hereby, the total scores for vasomotor aspects were from 2 to 12, for psychosocial aspects were from 6 to 36, for physical aspects were from 16 to 96 and for sexual aspects were from 2 to 12. The total score of quality-of-life for each participant could be from 26 (the lowest level) to 156 (the highest level) points. The more the scores decreased, the better the quality-of-life became (13).Of all questions in the original Hilditch questionnaire, we selected and utilized 26 questions in this study . According to the scoring system of original version of Menopause Specific Quality of Life Questionnaire (MENQOL), each question should have been scored by 8 points. However, because of the similarities among some points, two points were omitted in Rotem Regarding the perception of our participants, their culture and the period of conducting the study, we had to modify the questionnaire in order to make time and cultural adaptation. We omitted three questions from the original MENQOL questionnaire: the item \u2018sweating\u2019 was omitted from vasomotor domain, because half of the study was carried out during the end of spring and beginning of summer and the weather was warm-to-hot during the study. If we had put the item \u2018sweating\u2019, participants might probably have misreported the daily sweating due to warm weather, not real flashes; because of the different perceptions that Iranian people have, the item \u2018avoiding intimacy\u2019 was omitted from sexual domain; it might have been misinterpreted by each of participants and they might have been confused between emotional intimacy, physical intimacy and sexual intimacy; the item \u2018dissatisfaction with my personal life\u2019 was skipped from psycho-social domain, because so many factors are influencing the personal life and these factors differ from person to person and community to community. Regarding these changes, we rechecked the validity and reliability of new modified questionnaire. We proceeded to evaluate our modified questionnaire and six-point scoring system. By recruiting a panel of experts to review the test specifications and the selection of items, the content validity of modified questionnaire was approved. The experts were able to review the items and comment on whether the items cover a representative sample of each domain. Moreover, using modified questionnaire, we did a pilot study on 25 menopausal women referring to an outpatient clinic and Cronbach \u03b1 approved the reliability of questionnaire (0.85).Participants randomly allocated in two groups as control and study groups in the following way: we listed all of the eligible people and assigned each member of the population a numerical label. Then, using a random table, we pointed a finger on the table in order to choose an arbitrary and random starting point. The one, who possessed that number, was the first participant in study group. Next, we moved across the row of numbers to the very next number to select the first subject in control group. If the next number was less than 62, it was taken as a sample. We continued and assigned every other number to each of the groups until we had two groups that had 31 participants in each of them.After an initial evaluation and estimation of educational needs, educational intervention was performed weekly, for six consecutive weeks; each section lasted 45\u201360 min, sittings in the form of eight-person discussion groups. The content of the educational sessions were following: to give information about female genital organs, the definition of menopause and how it happens (the first session); to describe the symptoms and complications of menopause (the second session); to offer some approaches in order to diminish menopausal complications (the third and fourth session); to present training programs on exercise and its effect on the menopausal symptoms (the fifth session); and to describe muscle relaxation techniques and its effects on the severity of menopausal complications (the sixth session). At the end of each session, the summary of the instructed program was delivered to participants and at the end of the whole period of education, a booklet containing all of presented programs accompanied with the CD for relaxation techniques were given to the participants in the study group.The control group received no education and they had no contact with study personnel (or other participants) beyond recruitment and data collection.At third month after intervention, entire participants of two groups completed the MENQOL questionnaires.t-test in order to compare the mean scores for diverse criteria  within groups before and after the study. Independent t-test was used in order to compare the mean scores between groups before and after the study. Chi-square test was used for determining the differences among demographic status between groups and the quality-of-life measures in relation to age, the mean age at menopause and level of education. A P value less than 0.05 was considered as statistically significant.Data was processed using SPSS version 11.5 for windows. We used paired P > 0.05) [Thirty-one women in each study group completed the study. The mean age of participants was 50.63 \u00b1 2.7. The demographic status of both study groups were evaluated at the baseline  and there were no statistically significant differences in all baseline parameters between groups ( > 0.05) .P = 0.004). In the control group, comparing the scores before study, after study showed a statistically significant drop (P = 0.004).After educational intervention, a salient improvement was seen in the mean score for vasomotor symptoms compared to the scores prior to intervention (P = 0.001). However, in the control group a significant deterioration was registered (P = 0.001).The score for psychosocial function in the study group improved after intervention (P = 0.001). In the control group, it showed a significant negative growth (P = 0.001).Three months after intervention, mean scores for physical wellbeing compared to base scores in the study group showed a significant improvement (P = 0.001). Whereas, control group showed a significant opposite movement (P = 0.001).In terms of sexual health, the study group showed a significant improvement (P = 0.001). Nevertheless, control group showed a significant deterioration in their sense of wellbeing (P = 0.001) [Three months after education, score for quality-of-life in the study group was improved significantly (= 0.001) .P = 0.001) [There was a statistically significant difference between study and control groups, three months after educational intervention, according to the mean score for vasomotor symptoms, psychosocial aspect, physical wellbeing, sexual health and quality-of-life (= 0.001) .The goal of the present intervention was improving quality-of-life. As a rule, simple but effective interventions would be beneficial for all kinds of diseases and discomforts.Setting a random sampling and using self-administered questionnaires that the researcher did not have any role in completing them, we aimed to conduct a bias-free study. Using discussion group and putting participants in touch with the others, women were able to talk with each other about their experiences.et al. study in Ecuador,. Many studies have shown that differences in demographic characteristics could affect the women's quality of lives. According to Peter Chedraui  Ecuador, the qual Ecuador,Due to the finding in our study that the majority of subjects had a lower level of education and a lack of proper sources of information , the need for planning and implementation of an educational program becomes more apparent.P = 0.004) and the difference between post-intervention scores of the study group and those of the control group was significant (P = 0.001). Therefore, it can be said that the intervention led to an improvement in vasomotor symptoms of the study group. Our findings are similar to those of Booth-Laforce et al.,; while the control group had a significant deterioration. Likewise the comparison of mean score, in the same aspect, showed a significant difference between the study and control groups after intervention (0.001). Therefore, the applied intervention led to improvement of psychosocial status in participants. This finding is similar to the result of Elavsky et al.(et al.(Our finding showed a significant improvement in psychosocial wellbeing in the study group, three months after intervention (ky et al. study, wl.(et al. who repoet al.(Following betterment in hot flashes, the study group showed a significant improvement in sexual health, which their changes were significantly better than that of the control group. Lobo et al. pointed et al. in Nigeret al.(Quality-of-life improved significantly in the study group following intervention while the controls significantly regressed in the same. The mean scores in the study group, in addition, were significantly better following their education. This finding confirms that of Keefer et al. who repoThe finding of this study asserted that the four aspects of quality-of-life well improved after educational intervention, and the education can cause an improvement in the quality-of-life by decreasing the problems of menopause stage and lowering their intensity,. Therefore, the urgency of need to planning and implementing an appropriate educational program is emphasized in order to promote the quality-of-life in this group of people.This study was conducted to evaluate the effect of education on the quality-of-life and the improvement of health standards in menopausal women. Our findings showed that an appropriate training to menopausal women can improve their quality-of-life and promote their health.", "texts": ["In menopausal women, the term quality-of-life incorporates its physical symptoms such as hot flushes, night sweats and vaginal mucosa dryness. We set out this study in order to evaluate the effect of education on the quality-of-life and the improvement of health standards in menopausal women.Women are one of the most important parts of the family and society, and community health is dependent on provision of the needs of this group. Menopause is one of the most critical stages of life among women. One of the aims of health services for all of the people in the 21Sixty-two women aged 44\u201355 referring to and academic outpatient clinic in Shiraz were selected by simple random sampling, and allocated in two groups. Data was collected using a modified Hildich questionnaire on quality-of-life in menopause stage. Quality-of-life of the subjects  were evaluated prior to and 3 months after educational intervention.P = 0.001). A significant difference was seen between groups in terms of changing quality-of-life after intervention (P = 0.001).Mean quality-of-life score in study and control groups, prior to education, was 81.7 and 74.8; changing to 75.3 and 75.8, respectively three months after intervention. The study group showed a significant improvement in their quality-of-life (Appropriate training to menopausal women improves their quality-of-life and promotes their health. Women are among the most important part of any society and family, and community health provision is dependent on the fulfillment of different health needs. On the other hand, menopause is one of the most critical stages of women health. Definingst century is to improve quality-of-life. in Shiraz was evaluated during 2007\u20132008. The Medical Research Ethics Committee of Shiraz University of Medical Sciences approved the study. All of participants signed informed consent and they were assured of guarantees of confidentiality and anonymity during and after the study.From power calculation, by means of a prior pilot study, 31 women in each treatment group with at least 25 completing the study were needed for 95% power to detect at least 5% difference in the quality-of-life.Patients considered for this study were healthy, premenopause or menopause women. InclusioScores for quality-of-life in the study and control groups were evaluated and compared in two stages  both between and within the groups as changes before and after education.In order to collect data on quality-of-life, we used a questionnaire containing 29 questions about quality-of-life in menopause designed by Hilditch. The qualet al. study (13). Using Likert scoring method, each question could be scored by 6 points . Hereby, the total scores for vasomotor aspects were from 2 to 12, for psychosocial aspects were from 6 to 36, for physical aspects were from 16 to 96 and for sexual aspects were from 2 to 12. The total score of quality-of-life for each participant could be from 26 (the lowest level) to 156 (the highest level) points. The more the scores decreased, the better the quality-of-life became (13).Of all questions in the original Hilditch questionnaire, we selected and utilized 26 questions in this study . According to the scoring system of original version of Menopause Specific Quality of Life Questionnaire (MENQOL), each question should have been scored by 8 points. However, because of the similarities among some points, two points were omitted in Rotem Regarding the perception of our participants, their culture and the period of conducting the study, we had to modify the questionnaire in order to make time and cultural adaptation. We omitted three questions from the original MENQOL questionnaire: the item \u2018sweating\u2019 was omitted from vasomotor domain, because half of the study was carried out during the end of spring and beginning of summer and the weather was warm-to-hot during the study. If we had put the item \u2018sweating\u2019, participants might probably have misreported the daily sweating due to warm weather, not real flashes; because of the different perceptions that Iranian people have, the item \u2018avoiding intimacy\u2019 was omitted from sexual domain; it might have been misinterpreted by each of participants and they might have been confused between emotional intimacy, physical intimacy and sexual intimacy; the item \u2018dissatisfaction with my personal life\u2019 was skipped from psycho-social domain, because so many factors are influencing the personal life and these factors differ from person to person and community to community. Regarding these changes, we rechecked the validity and reliability of new modified questionnaire. We proceeded to evaluate our modified questionnaire and six-point scoring system. By recruiting a panel of experts to review the test specifications and the selection of items, the content validity of modified questionnaire was approved. The experts were able to review the items and comment on whether the items cover a representative sample of each domain. Moreover, using modified questionnaire, we did a pilot study on 25 menopausal women referring to an outpatient clinic and Cronbach \u03b1 approved the reliability of questionnaire (0.85).Participants randomly allocated in two groups as control and study groups in the following way: we listed all of the eligible people and assigned each member of the population a numerical label. Then, using a random table, we pointed a finger on the table in order to choose an arbitrary and random starting point. The one, who possessed that number, was the first participant in study group. Next, we moved across the row of numbers to the very next number to select the first subject in control group. If the next number was less than 62, it was taken as a sample. We continued and assigned every other number to each of the groups until we had two groups that had 31 participants in each of them.After an initial evaluation and estimation of educational needs, educational intervention was performed weekly, for six consecutive weeks; each section lasted 45\u201360 min, sittings in the form of eight-person discussion groups. The content of the educational sessions were following: to give information about female genital organs, the definition of menopause and how it happens (the first session); to describe the symptoms and complications of menopause (the second session); to offer some approaches in order to diminish menopausal complications (the third and fourth session); to present training programs on exercise and its effect on the menopausal symptoms (the fifth session); and to describe muscle relaxation techniques and its effects on the severity of menopausal complications (the sixth session). At the end of each session, the summary of the instructed program was delivered to participants and at the end of the whole period of education, a booklet containing all of presented programs accompanied with the CD for relaxation techniques were given to the participants in the study group.The control group received no education and they had no contact with study personnel (or other participants) beyond recruitment and data collection.At third month after intervention, entire participants of two groups completed the MENQOL questionnaires.t-test in order to compare the mean scores for diverse criteria  within groups before and after the study. Independent t-test was used in order to compare the mean scores between groups before and after the study. Chi-square test was used for determining the differences among demographic status between groups and the quality-of-life measures in relation to age, the mean age at menopause and level of education. A P value less than 0.05 was considered as statistically significant.Data was processed using SPSS version 11.5 for windows. We used paired P > 0.05) [Thirty-one women in each study group completed the study. The mean age of participants was 50.63 \u00b1 2.7. The demographic status of both study groups were evaluated at the baseline  and there were no statistically significant differences in all baseline parameters between groups ( > 0.05) .P = 0.004). In the control group, comparing the scores before study, after study showed a statistically significant drop (P = 0.004).After educational intervention, a salient improvement was seen in the mean score for vasomotor symptoms compared to the scores prior to intervention (P = 0.001). However, in the control group a significant deterioration was registered (P = 0.001).The score for psychosocial function in the study group improved after intervention (P = 0.001). In the control group, it showed a significant negative growth (P = 0.001).Three months after intervention, mean scores for physical wellbeing compared to base scores in the study group showed a significant improvement (P = 0.001). Whereas, control group showed a significant opposite movement (P = 0.001).In terms of sexual health, the study group showed a significant improvement (P = 0.001). Nevertheless, control group showed a significant deterioration in their sense of wellbeing (P = 0.001) [Three months after education, score for quality-of-life in the study group was improved significantly (= 0.001) .P = 0.001) [There was a statistically significant difference between study and control groups, three months after educational intervention, according to the mean score for vasomotor symptoms, psychosocial aspect, physical wellbeing, sexual health and quality-of-life (= 0.001) .The goal of the present intervention was improving quality-of-life. As a rule, simple but effective interventions would be beneficial for all kinds of diseases and discomforts.Setting a random sampling and using self-administered questionnaires that the researcher did not have any role in completing them, we aimed to conduct a bias-free study. Using discussion group and putting participants in touch with the others, women were able to talk with each other about their experiences.et al. study in Ecuador,. Many studies have shown that differences in demographic characteristics could affect the women's quality of lives. According to Peter Chedraui  Ecuador, the qual Ecuador,Due to the finding in our study that the majority of subjects had a lower level of education and a lack of proper sources of information , the need for planning and implementation of an educational program becomes more apparent.P = 0.004) and the difference between post-intervention scores of the study group and those of the control group was significant (P = 0.001). Therefore, it can be said that the intervention led to an improvement in vasomotor symptoms of the study group. Our findings are similar to those of Booth-Laforce et al.,; while the control group had a significant deterioration. Likewise the comparison of mean score, in the same aspect, showed a significant difference between the study and control groups after intervention (0.001). Therefore, the applied intervention led to improvement of psychosocial status in participants. This finding is similar to the result of Elavsky et al.(et al.(Our finding showed a significant improvement in psychosocial wellbeing in the study group, three months after intervention (ky et al. study, wl.(et al. who repoet al.(Following betterment in hot flashes, the study group showed a significant improvement in sexual health, which their changes were significantly better than that of the control group. Lobo et al. pointed et al. in Nigeret al.(Quality-of-life improved significantly in the study group following intervention while the controls significantly regressed in the same. The mean scores in the study group, in addition, were significantly better following their education. This finding confirms that of Keefer et al. who repoThe finding of this study asserted that the four aspects of quality-of-life well improved after educational intervention, and the education can cause an improvement in the quality-of-life by decreasing the problems of menopause stage and lowering their intensity,. Therefore, the urgency of need to planning and implementing an appropriate educational program is emphasized in order to promote the quality-of-life in this group of people.This study was conducted to evaluate the effect of education on the quality-of-life and the improvement of health standards in menopausal women. Our findings showed that an appropriate training to menopausal women can improve their quality-of-life and promote their health."]}
{"representative": "Experiencing autonomy is recognised to promote health and well-being for all age groups. Perceived lack of control has been found to be detrimental to physical and mental health. There is a lack of evidence-based knowledge elucidating how frail older people in nursing home settings themselves perceive autonomy in daily life. Further, there are no studies on the extent to which this perception can be influenced positively by participating in an individually tailored programme based on residents' own wishes for daily activities.A total of 9 nursing homes and 55 participants aged 65 years or older were included in the study. All the participants were restricted in performing at least one P-ADL activity unassisted and had a Mini Mental State Examination-score above 16. Perceived autonomy was measured at baseline, after 12 weeks and after 24 weeks by The Autonomy Sub-dimension in the Measure of Actualisation of Potential test. Programmes were based on participants' individual assessment of their most important daily activities. Staff at all nursing homes who usually organize physical training, social or creative activities carried out individually tailored programmes using their usual methods and equipment. Participants in each nursing home were divided by lot into either a control group or an intervention group. The control groups received their usual care and treatment.This study is designed to assess the status of perceived autonomy at baseline and to provide information about the effectiveness of individually tailored programmes according to perceptions of autonomy registered in institutionalised physically frail older people. This will add knowledge to assist response to present and future challenges in relation to health promotion initiatives for this group.NCT00783055 The development of elderly care services is of prime concern across Europe due to demographic trends which show an increasing elderly population . The DanPerceived lack of control has been found to be injurious to older peoples' physical and mental health, and when despite their frailty older people experience autonomy they become more alert both mentally and physically and their self-rated well-being improves -8. Due tWhen older people are exposed to changes such as moving into a nursing home their physical and psychological problems ,9 and feThe concept of autonomy is often used interchangeably with the experience of having choices and being in control. Perceived lack of control has been found to be detrimental to physical and mental health , and, whIt is generally acknowledged that frail older people in nursing home settings to some degree are restricted in the execution of their choices and wishes. This calls for a more specified definition of the concept of autonomy that takes frailty and thereby dependency into consideration. According to Agich 'There is no opposition to dependency \u2013 not when one relies on others in a way that is consistent with one's sense of self-worth and identity' . A numbeThe sense of control over their activities exerts a positive influence on older adults' well-being ,30 even Research demonstrates that it is possible to experience autonomy while being dependent on assistance, and that older people's perception of independence changes with the process of functional decline. It is, therefore, not only their actual performance but also their ability to make meaningful choices and decisions that are of importance . HoweverThe aim of the present study is to assess the short-term (0\u201312 weeks) and long-term (12\u201324 weeks) changes of an individually tailored programme based on residents' own wishes for activity on their perceived autonomy.The study was approved by The Regional Scientific Ethical Committee in Denmark No. 2004-1-52 and The Danish Data Protection Agency.This study is the Danish part of a Nordic multi-centre study, where the aim is to describe the impact of individually tailored programmes in nursing home settings on residents' physical functioning, dependence in ADL and self-rated well-being. The multi-centre study includes three Nordic countries and is initiated and designed by a group of Swedish researchers.A number of physical and mental tests are carried out and information on age, diseases, medicine, aids and length of staying at the nursing home is registered. In the Danish part of the study, a test has been added in order to measure perceived autonomy before and after the intervention period. This paper concentrates only on the assessment of the status of perceived autonomy and the effect of individually tailored programmes on perceived autonomy among physically frail older people in nursing home settings. The individual programmes are based on the participants' individual wishes according to the specific daily activities they wish to improve, to preserve and/or to revive.The intervention group participated in a 12 \u2013 week programme, whereas the control group received their usual care and treatment. After a 6 month period they were offered an individual programme according to their wishes for activities  received an invitation letter informing about the project. The nursing homes were situated in a large geographical area of Denmark including rural areas, larger cities and the capital of Denmark. Invitations were sent in four rounds during a one and a half-year period from February 2005 to June 2006. A total of 20 nursing homes responded and of these 9 wanted to participate. The 9 nursing homes represent both small and larger nursing homes and are geographically placed in both the countryside and in cities.Residents, relatives and staff from all involved nursing homes attended information meetings. Local politicians were also present at some of the meetings. Information about participation, duration of the study and clarification of the staff's roles were on the agenda and if necessary the meetings were repeated in order to ensure that everybody was informed.Physically frail elderly nursing home residents were recruited directly at the above mentioned information meetings or at a visit conducted by a well-known staff member in their home. The staff at each nursing home was responsible for informing participants face to face and for collecting the signed informed consent. Participants were informed about randomisation to either an intervention or a control group.Aged 65 years or older, participants with all kinds of diseases leading to physical frailty ensuring an unselected case-mix, dependence on daily assistance in minimum one P-ADL activity , able to understand verbal instructions, willing to participate, expected to live in the nursing home during the intervention period. Both men and women.Terminal stages of disease, MMSE-score below 16 .Participants were divided by lot into either a control group or an intervention group.The randomisation was stratified according to sex.The intervention groups participated in individually tailored 12 \u2013 week programmes, whereas the control groups received usual care and treatment.Participants' identity and group allocation were only identifiable for the researcher.Blinded research assistants did the testing. Previous training sessions for testers and the use of scripts during the testing had to ensure that all participants received the same instructions.A total of 55 older people were included according to the autonomy study of which 50 participated.A number of measures were collected for the purpose of characterising the total cohort at baseline, in terms of age, sex, length of stay in the nursing home, most frequent diseases, most frequent medicine prescribed and walking/mobility aids Table .Five participants dropped out: three from the control group and two from the intervention group. Typical reasons for drop \u2013 out were withdrawal due to either aggravation of disease or death.Descriptions of Danish nursing home residents are scarce and therefore the following characteristics are based on the one existing and recent study by Beck et al  which chIn general, the staff comprises of nurses, auxiliary nurses, cleaning staff, occupational therapists, physiotherapists and volunteers.inside is that a reception area leads to corridors with front doors to residents' individual flats. Further, a corridor leads to common areas such as dining rooms, caf\u00e9, training facilities etc. Residents rent their own individual flat with a bathroom, a kitchen and a living room/bedroom. The outside environment usually has a common garden area with benches and flowers.Typical of the physical environment Daily life is characterised by schedules for most activities such as mealtimes, bedtimes, physical training, social or creative activities.preserving residents' autonomy.Nursing homes have to list their moral values \u2013 often on the nursing home's own website \u2013 and the list frequently includes Although there were some differences, all 9 nursing homes included in this study complied with the earlier mentioned regulations about housing for the frail and old. Among the differences was for example the fact that some only consisted of a ground level while others had more floors. Some were less accessible regarding distance, e.g. to the front door, garden, training facilities and dining room.In a few nursing homes occupational therapists and physiotherapists were employed by the local community council to serve more than one nursing home and therefore not able to be present in the nursing home on a daily basis.The Autonomy Sub-dimension in the MAP test  [Perceived autonomy was measured at T1, T2 and T3 by using tential) -33. The tential) -33.With permission from the Canadian authors, The Autonomy Subscale was validated to be used in Denmark by the researcher under statistical supervision in 2005.The Autonomy Sub-dimension can be used separately and represents a subjective measure which elucidates perceived autonomy. Six items are scored on a 5 \u2013 point Likert type scale and the test is performed as a paper and pencil test where the tester and the participant are sitting at the same side of the table. The tester reads the text and the participant chooses the response. Each sentence is read out loud in order to avoid misunderstandings.low, average or high degree of autonomy.The mean of all six scores forms the result and is categorised as either: The testing procedure involved a training programme concerning testing procedures in order to assure a high inter-rater reliability. The training programme ran over a three \u2013 week period and involved a thorough verbal and written presentation of test material and a manual, exercises, feed-back and de-briefing.type, with whom, where, duration per time and frequency per day/week.Staff at each nursing home who usually organizes physical training, social or creative activities carried out the individual programmes for the intervention groups utilizing their usual methods and equipment. The individual programme was planned together with the participant. Furthermore, the staff registered the participant's activities in terms of: The statistical analytical program SPSS version 15.0 and 16.0 will be used for registration, analysis and presentation of data.The changes from 0\u201312 weeks and 12\u201324 weeks within the two groups separately will be assessed using paired t-test  and/or Wilcoxon rank sum test for variables not fulfilling the normal distribution of residuals. Furthermore, bar charts will be made for delta values for the changes from 0\u201312 weeks and 12\u201324 weeks.The analyses will be performed according to the intention-to-treat principle, and carried out using a regression model incorporating difference in changes , and controlling for baseline values, e.g. age and gender.Furthermore, the content of the individual programmes and participants' activity wishes will be analysed using a thematic analysis.Participants of this study represent a group of people who might be in a deficit of stimulation due to being physically frail and institutionalised. Therefore, changes in the control groups are expected.Statistical significance is set at p < 0.05.The statistics will be performed in cooperation with The Research Unit for Statistics, Faculty of Health Sciences at The University of Southern Denmark.Sample size estimations were initially based on the calculations done for the Nordic multicenter study. These estimations show that to obtain a power of at least 80% and a significance level of 5%, 60 participants in each group are sufficient. No previous studies have investigated the effect of individually tailored programmes on perceived autonomy and thus it was difficult to determine an appropriate sample size. Therefore it was decided to recruit the largest possible number of subjects and aim for at least 60 in each group.Many studies concerning autonomy in nursing home settings focus either primarily on the staff perspective or evaluate how staff and residents perceive autonomy in pre-defined areas of daily life. A recent European study including five countries argues, in agreement with many other studies, that comparison of nurses' and residents' views on autonomy reflect different results . HoweverIf the results of this study are promising, future efforts might be directed at developing guidelines for more effective approaches to ensure frail older institutionalised peoples' autonomy in daily life. The hypothesis is that these efforts will lead not only to experiences of autonomy but also to enhanced mobility, independence, participation and well-being.The authors declare that they have no competing interests.Both authors contributed to the design of the study and wrote the paper together. MA administered the study, was responsible for collecting the data and for performing the statistical analyses. LP provided guidance and supervision during the whole process. Both authors contributed significantly to the preparation of the paper, and read and approved the final version.The pre-publication history for this paper can be accessed here:", "texts": ["Experiencing autonomy is recognised to promote health and well-being for all age groups. Perceived lack of control has been found to be detrimental to physical and mental health. There is a lack of evidence-based knowledge elucidating how frail older people in nursing home settings themselves perceive autonomy in daily life. Further, there are no studies on the extent to which this perception can be influenced positively by participating in an individually tailored programme based on residents' own wishes for daily activities.A total of 9 nursing homes and 55 participants aged 65 years or older were included in the study. All the participants were restricted in performing at least one P-ADL activity unassisted and had a Mini Mental State Examination-score above 16. Perceived autonomy was measured at baseline, after 12 weeks and after 24 weeks by The Autonomy Sub-dimension in the Measure of Actualisation of Potential test. Programmes were based on participants' individual assessment of their most important daily activities. Staff at all nursing homes who usually organize physical training, social or creative activities carried out individually tailored programmes using their usual methods and equipment. Participants in each nursing home were divided by lot into either a control group or an intervention group. The control groups received their usual care and treatment.This study is designed to assess the status of perceived autonomy at baseline and to provide information about the effectiveness of individually tailored programmes according to perceptions of autonomy registered in institutionalised physically frail older people. This will add knowledge to assist response to present and future challenges in relation to health promotion initiatives for this group.NCT00783055 The development of elderly care services is of prime concern across Europe due to demographic trends which show an increasing elderly population . The DanPerceived lack of control has been found to be injurious to older peoples' physical and mental health, and when despite their frailty older people experience autonomy they become more alert both mentally and physically and their self-rated well-being improves -8. Due tWhen older people are exposed to changes such as moving into a nursing home their physical and psychological problems ,9 and feThe concept of autonomy is often used interchangeably with the experience of having choices and being in control. Perceived lack of control has been found to be detrimental to physical and mental health , and, whIt is generally acknowledged that frail older people in nursing home settings to some degree are restricted in the execution of their choices and wishes. This calls for a more specified definition of the concept of autonomy that takes frailty and thereby dependency into consideration. According to Agich 'There is no opposition to dependency \u2013 not when one relies on others in a way that is consistent with one's sense of self-worth and identity' . A numbeThe sense of control over their activities exerts a positive influence on older adults' well-being ,30 even Research demonstrates that it is possible to experience autonomy while being dependent on assistance, and that older people's perception of independence changes with the process of functional decline. It is, therefore, not only their actual performance but also their ability to make meaningful choices and decisions that are of importance . HoweverThe aim of the present study is to assess the short-term (0\u201312 weeks) and long-term (12\u201324 weeks) changes of an individually tailored programme based on residents' own wishes for activity on their perceived autonomy.The study was approved by The Regional Scientific Ethical Committee in Denmark No. 2004-1-52 and The Danish Data Protection Agency.This study is the Danish part of a Nordic multi-centre study, where the aim is to describe the impact of individually tailored programmes in nursing home settings on residents' physical functioning, dependence in ADL and self-rated well-being. The multi-centre study includes three Nordic countries and is initiated and designed by a group of Swedish researchers.A number of physical and mental tests are carried out and information on age, diseases, medicine, aids and length of staying at the nursing home is registered. In the Danish part of the study, a test has been added in order to measure perceived autonomy before and after the intervention period. This paper concentrates only on the assessment of the status of perceived autonomy and the effect of individually tailored programmes on perceived autonomy among physically frail older people in nursing home settings. The individual programmes are based on the participants' individual wishes according to the specific daily activities they wish to improve, to preserve and/or to revive.The intervention group participated in a 12 \u2013 week programme, whereas the control group received their usual care and treatment. After a 6 month period they were offered an individual programme according to their wishes for activities  received an invitation letter informing about the project. The nursing homes were situated in a large geographical area of Denmark including rural areas, larger cities and the capital of Denmark. Invitations were sent in four rounds during a one and a half-year period from February 2005 to June 2006. A total of 20 nursing homes responded and of these 9 wanted to participate. The 9 nursing homes represent both small and larger nursing homes and are geographically placed in both the countryside and in cities.Residents, relatives and staff from all involved nursing homes attended information meetings. Local politicians were also present at some of the meetings. Information about participation, duration of the study and clarification of the staff's roles were on the agenda and if necessary the meetings were repeated in order to ensure that everybody was informed.Physically frail elderly nursing home residents were recruited directly at the above mentioned information meetings or at a visit conducted by a well-known staff member in their home. The staff at each nursing home was responsible for informing participants face to face and for collecting the signed informed consent. Participants were informed about randomisation to either an intervention or a control group.Aged 65 years or older, participants with all kinds of diseases leading to physical frailty ensuring an unselected case-mix, dependence on daily assistance in minimum one P-ADL activity , able to understand verbal instructions, willing to participate, expected to live in the nursing home during the intervention period. Both men and women.Terminal stages of disease, MMSE-score below 16 .Participants were divided by lot into either a control group or an intervention group.The randomisation was stratified according to sex.The intervention groups participated in individually tailored 12 \u2013 week programmes, whereas the control groups received usual care and treatment.Participants' identity and group allocation were only identifiable for the researcher.Blinded research assistants did the testing. Previous training sessions for testers and the use of scripts during the testing had to ensure that all participants received the same instructions.A total of 55 older people were included according to the autonomy study of which 50 participated.A number of measures were collected for the purpose of characterising the total cohort at baseline, in terms of age, sex, length of stay in the nursing home, most frequent diseases, most frequent medicine prescribed and walking/mobility aids Table .Five participants dropped out: three from the control group and two from the intervention group. Typical reasons for drop \u2013 out were withdrawal due to either aggravation of disease or death.Descriptions of Danish nursing home residents are scarce and therefore the following characteristics are based on the one existing and recent study by Beck et al  which chIn general, the staff comprises of nurses, auxiliary nurses, cleaning staff, occupational therapists, physiotherapists and volunteers.inside is that a reception area leads to corridors with front doors to residents' individual flats. Further, a corridor leads to common areas such as dining rooms, caf\u00e9, training facilities etc. Residents rent their own individual flat with a bathroom, a kitchen and a living room/bedroom. The outside environment usually has a common garden area with benches and flowers.Typical of the physical environment Daily life is characterised by schedules for most activities such as mealtimes, bedtimes, physical training, social or creative activities.preserving residents' autonomy.Nursing homes have to list their moral values \u2013 often on the nursing home's own website \u2013 and the list frequently includes Although there were some differences, all 9 nursing homes included in this study complied with the earlier mentioned regulations about housing for the frail and old. Among the differences was for example the fact that some only consisted of a ground level while others had more floors. Some were less accessible regarding distance, e.g. to the front door, garden, training facilities and dining room.In a few nursing homes occupational therapists and physiotherapists were employed by the local community council to serve more than one nursing home and therefore not able to be present in the nursing home on a daily basis.The Autonomy Sub-dimension in the MAP test  [Perceived autonomy was measured at T1, T2 and T3 by using tential) -33. The tential) -33.With permission from the Canadian authors, The Autonomy Subscale was validated to be used in Denmark by the researcher under statistical supervision in 2005.The Autonomy Sub-dimension can be used separately and represents a subjective measure which elucidates perceived autonomy. Six items are scored on a 5 \u2013 point Likert type scale and the test is performed as a paper and pencil test where the tester and the participant are sitting at the same side of the table. The tester reads the text and the participant chooses the response. Each sentence is read out loud in order to avoid misunderstandings.low, average or high degree of autonomy.The mean of all six scores forms the result and is categorised as either: The testing procedure involved a training programme concerning testing procedures in order to assure a high inter-rater reliability. The training programme ran over a three \u2013 week period and involved a thorough verbal and written presentation of test material and a manual, exercises, feed-back and de-briefing.type, with whom, where, duration per time and frequency per day/week.Staff at each nursing home who usually organizes physical training, social or creative activities carried out the individual programmes for the intervention groups utilizing their usual methods and equipment. The individual programme was planned together with the participant. Furthermore, the staff registered the participant's activities in terms of: The statistical analytical program SPSS version 15.0 and 16.0 will be used for registration, analysis and presentation of data.The changes from 0\u201312 weeks and 12\u201324 weeks within the two groups separately will be assessed using paired t-test  and/or Wilcoxon rank sum test for variables not fulfilling the normal distribution of residuals. Furthermore, bar charts will be made for delta values for the changes from 0\u201312 weeks and 12\u201324 weeks.The analyses will be performed according to the intention-to-treat principle, and carried out using a regression model incorporating difference in changes , and controlling for baseline values, e.g. age and gender.Furthermore, the content of the individual programmes and participants' activity wishes will be analysed using a thematic analysis.Participants of this study represent a group of people who might be in a deficit of stimulation due to being physically frail and institutionalised. Therefore, changes in the control groups are expected.Statistical significance is set at p < 0.05.The statistics will be performed in cooperation with The Research Unit for Statistics, Faculty of Health Sciences at The University of Southern Denmark.Sample size estimations were initially based on the calculations done for the Nordic multicenter study. These estimations show that to obtain a power of at least 80% and a significance level of 5%, 60 participants in each group are sufficient. No previous studies have investigated the effect of individually tailored programmes on perceived autonomy and thus it was difficult to determine an appropriate sample size. Therefore it was decided to recruit the largest possible number of subjects and aim for at least 60 in each group.Many studies concerning autonomy in nursing home settings focus either primarily on the staff perspective or evaluate how staff and residents perceive autonomy in pre-defined areas of daily life. A recent European study including five countries argues, in agreement with many other studies, that comparison of nurses' and residents' views on autonomy reflect different results . HoweverIf the results of this study are promising, future efforts might be directed at developing guidelines for more effective approaches to ensure frail older institutionalised peoples' autonomy in daily life. The hypothesis is that these efforts will lead not only to experiences of autonomy but also to enhanced mobility, independence, participation and well-being.The authors declare that they have no competing interests.Both authors contributed to the design of the study and wrote the paper together. MA administered the study, was responsible for collecting the data and for performing the statistical analyses. LP provided guidance and supervision during the whole process. Both authors contributed significantly to the preparation of the paper, and read and approved the final version.The pre-publication history for this paper can be accessed here:"]}
{"representative": "Acute respiratory illness (ARI) is the most common cause of acute presentations and hospitalisations of young Indigenous children in Australia and New Zealand (NZ). Environmental tobacco smoke (ETS) from household smoking is a significant and preventable contributor to childhood ARI. This paper describes the protocol for a study which aims to test the efficacy of a family-centred tobacco control program about ETS to improve the respiratory health of Indigenous infants in Australia and New Zealand. For the purpose of this paper 'Indigenous' refers to Australia's Aboriginal and Torres Strait Islander peoples when referring to Australian Indigenous populations. In New Zealand, the term 'Indigenous' refers to M\u0101ori.This study will be a parallel, randomized, controlled trial. Participants will be Indigenous women and their infants, half of whom will be randomly allocated to an 'intervention' group, who will receive the tobacco control program over three home visits in the first three months of the infant's life and half to a control group receiving 'usual care' (i.e. they will not receive the tobacco control program). Indigenous health workers will deliver the intervention, the goal of which is to reduce or eliminate infant exposure to ETS. Data collection will occur at baseline (shortly after birth) and when the infant is four months and one year of age. The primary outcome is a doctor-diagnosed, documented case of respiratory illness in participating infants.Interventions aimed at reducing exposure of Indigenous children to ETS have the potential for significant benefits for Indigenous communities. There is currently a dearth of evidence for the effect of tobacco control interventions to reduce children's exposure to ETS among Indigenous populations. This study will provide high-quality evidence of the efficacy of a family-centred tobacco control program on ETS to reduce respiratory illness. Outcomes of our study will be important and significant for Indigenous tobacco control in Australia and New Zealand and prevention of respiratory illness in children.Australian New Zealand Clinical Trials Registry (ACTRN12609000937213) Globally, acute respiratory infections (ARI) cause more deaths and hospitalisations among Indigenous children compared with their age-matched counterparts; the greatest impact is among young children aged 0-4 years . SpecifiWhile there are multiple socioeconomic determinants of ARIs among Indigenous children, environmental tobacco smoke (ETS) exposure is arguably the most readily amenable to modification. The adverse health effects of ETS are well documented, especially its association with respiratory illness. The association between parental smoking and childhood respiratory disease is strongest at younger ages . In chilIn recognition of the damaging health effects of ETS, the World Health Organization (WHO) has prioritised the need to reduce parental smoking as a core component of improving health and development in early childhood . This isDespite the recognition of the adverse child health effects of ETS and the scale of the problem among disadvantaged populations in particular, exposure reduction in homes is a relatively recent area of scientific study . A recenThis study aims to test the efficacy of a culturally appropriate, family-centred tobacco control program about ETS to improve the respiratory health of Indigenous infants in Australia and NZ.Infants (<12 months) of Indigenous mothers/caregivers who receive an intensive family-centred tobacco control program about ETS, compared with 'usual care,' will have fewer health care presentations for respiratory illness.The primary objective of this study is to determine the efficacy of a family-centred tobacco control program about ETS, to reduce health care presentations for respiratory illness in Indigenous infants in the first year of life. Secondary objectives include assessment of the effect of such a program on a range of measures of infant ETS exposure, including mother/caregiver's self-report of infant exposure to ETS and implementation of smoking restrictions in the home and/or car, infant urinary cotinine, household smoking status, mother/caregiver's smoking cessation and quit attempts. A process evaluation of the family-centred tobacco control program will also be undertaken.This study will be a parallel, randomized controlled study with allocation concealed from the study researchers. Participants will be randomly allocated to one of two study arms: the 'intervention' group who will receive the tobacco control program about ETS exposure over three home visits in the first three months of the infant's life, or the control group who will receive 'usual care' (i.e. they will not receive the tobacco control program). IHWs will be trained to deliver the intervention program, the goal of which is to reduce or eliminate exposure of infants to ETS. Data collection will occur at baseline (shortly after birth), and when the infant is four months and one year of age. The primary outcome of interest is the rate of health care presentations for doctor-diagnosed respiratory illness. Figure This study will be conducted in Darwin City and the Greater Darwin area in the Northern Territory, Australia; and within the Counties Manukau District Health Board region, Manukau City, NZ. The target populations for this study are Indigenous families who reside in these two geographical areas. The sampling unit is Indigenous newborn infants and their mothers/primary caregivers (aged 16 years and over).Infants will be eligible for inclusion if:\u2022 They are aged between 0-5 weeks. \u2022 Their mother/caregiver is Indigenous .\u2022 Their mother/caregiver is aged 16 years or over.\u2022 Their mother/caregiver currently smokes or the infant lives in a household where there is at least one other person who smokes (defined as smoking at least weekly).\u2022 Their mother/caregiver plans to reside permanently with the infant in Darwin or Greater Darwin areas of Australia or within the Counties Manukau District Health Board region, Manukau, NZ.\u2022 Their mother/caregiver has given signed written consent to participate in this research study.\u2022 Their mother/caregiver has given signed written consent for study staff to access the infant's health records.\u2022 They are a singleton or the first born in a multiple pregnancy delivery.\u2022 Their mother/caregiver speaks English and/or M\u0101ori.Infants will be excluded from the trial if:\u2022 They have serious neonatal respiratory complications .\u2022 They have other serious neonatal complications .\u2022 They have major organ abnormalities .The above exclusion criteria are because these infants will be given intense interventions to reduce ETS exposure regardless. Infants will also be excluded if:\u2022 Their mother/caregiver has previously been recruited in this research study.\u2022 They live in the same household as a mother/caregiver who has previously been recruited in this study.Participants will be randomized by computer with stratification using permuted blocks by country  and infant age . This will ensure a balance in these key prognostic indicators between the intervention and control groups. All participants (i.e. the infants) will be assigned a unique registration number allocated by a central computer following the submission of their details on a web-based form.This is an assessor blinded trial, with only the study researchers assigning the major primary and secondary outcome measures and trial statisticians blinded to group assignment. Research assistants, who will be responsible for collecting the minor outcome measures will accompany the health workers to the participants' homes for all visits and thus cannot be blinded. The primary outcome will however be a double-blinded measure.Globally, Indigenous notions of health and illness are generally defined more broadly than a Western biomedical definition that focuses more often on physical health or the absence of disease . In AustIn this study, the intervention program about ETS will be framed around an Indigenous model of health promotion, which attends to the psychological, physical, spiritual and cultural wellbeing of the individual and the family/community, as it relates to this project. In NZ, Te Whare Tapa Wha will be used. This model has been applied to understanding M\u0101ori smoking cessation behaviour  and for Participants will be told that they will be randomly assigned to a group that receives 'usual care', or a group that receives extra home visits by an IHW, and that a variety of study measurements will be taken over a 12-month period.Treatment group: The intervention program will (i) provide information and education about the health effects of ETS exposure and use behavioural 'coaching' techniques to help mothers/caregivers and family members implement strategies to reduce the infant's ETS exposure, as well as (ii) identify the smokers among other household members and deliver culturally appropriate smoking cessation advice, counselling and treatment options as requested. An eight weeks supply of free nicotine replacement therapy (NRT) (patches or gum) will be available to participants and other household members for whom such drug therapy is indicated . NRT will be provided by the IHW with appropriate counselling and follow-up. Furthermore, for those that are interested a fax referral to Quitline will be offered, with proactive call back by Quitline.\u2022 The intervention program will be delivered during three face-to-face home visits (of approximately 45-60 minutes) conducted over the first three months of the infant's life. Culturally appropriate resources  will be used to assist in both education and behavioural 'coaching'. These resources will be obtained from relevant health groups in each country who hold a repository of such resources . IHWs will deliver the program after appropriate training, and will complete standardised progress reports after each program session, which will be used at a weekly team meeting with the health workers and study personnel for discussion and ongoing training.Control group: The control group will receive 'usual' care through their community health provider. Usual care entails routine visits to maternal and child health providers at several defined time points during the first 12 months of the infant's life. At these postnatal visits, health providers check developmental milestones and general wellbeing. Additionally, mothers/caregivers routinely receive messages about smoking cessation and ETS exposure in their homes during these visits as part of general health promotion.\u2022 In addition to the above, the IHWs will briefly check that both groups have received the 'usual' care delivered to new mothers and their infants through routine 'well baby' visits in the first 12 months of life through their standard health provider . This will be undertaken at baseline, when the infant is four months and one year of age. The focus will be on key health promotion messages that should have been delivered at routine community health visits  Mothers/caregivers will be given a few key messages if they have not received this information, e.g. clear face, sleep on back for SIDS prevention. If these visits have not been attended or if the key messages have not been received by the mothers/caregivers, they will be referred back to their usual maternal and child health provider.Rate of health provider presentations for new primary episodes of ARI in the first year of life.Primary Outcome: All participating infants will be evaluated at baseline and when the infant is four and 12 months old, for the occurrence of medically attended acute respiratory illnesses (MAARI). These are defined as new onset events, including a change from the child's baseline medical status, referable to the upper and/or lower respiratory tracts. To identify episodes of ARI mothers/caregivers will be asked at baseline, and when the infant is four and 12 months old, whether their child has had any presentation to the clinic or hospital and the names of the clinics attended. Research assistants will collect the source data relevant to the primary outcome measures, so will review the individual child's health provider and hospital clinic records . Source documents will be photocopied, de-identified, labeled with the participant registration, and stored with the trial records. Two clinicians at each study centre will review the records and confirm documented respiratory illnesses without knowing the group allocation of the individual children. MAARI events will be evaluated by these clinicians to determine whether they are medically-attended upper respiratory infection (URI), lower respiratory infection (LRI) and/or otitis media infection .\u25aa Mother/caregiver's self-report of smoking restrictions in the home and car.\u25aa Mother/caregiver's self-report of smoking cessation: defined as mother/caregiver not smoking a single cigarette (not even a puff), in the preceding seven days. We will also be assessing prolonged abstinence .\u25aa Mother/caregiver's self-report of number quit attempts: defined as not smoking a cigarette for at least 24 hours.\u25aa Process evaluation indicators: a mix of quantitative and qualitative measures to assess how well the intervention program was implemented according to protocol e.g. number of 'coaching' activities completed, obstacles and successes in delivering program, parent satisfaction with the program.\u25aa A total sample size of 190 provides 90% power (5% significance) to detect a 25% reduction of new episodes of respiratory illness (primary outcome) in the intervention group compared to the control group. This is based on a conservative estimate of an average of 3 health provider visits per year in the control group, compared to an average of 2.25 visits in the intervention group . There are few published data on the community burden of ARIs in Northern Territory Indigenous children or NZ M\u0101ori children. In a recent study of disease burden and clinic attendances for young Indigenous children in two remote Northern Territory communities, the median number of presentations for upper respiratory illness in the first year of life was 7.5 (interquartile range 4-11) and for lower respiratory illness, 2.5 (interquartile range 1-5) . The oveIn Australia and NZ, mothers/caregivers will be approached for recruitment into the study through a range of community, Indigenous-controlled health and government hospital services. We will approach both pregnant women and new mothers to ascertain their interest in participating in the trial. If pregnant women are interested in the study, we will re-approach them after they have given birth. Eligible and interested mothers will be asked for their consent for randomization. Documented written consent will be obtained from all participants prior to entering the study. A range of project-specific advertising material will be produced  and local Indigenous media may be used to bolster recruitment.In 2006, there were approximately 240 Indigenous infants born to mothers who were resident in Darwin, Australia. We anticipate that 90% or 216 Indigenous infants/mothers will be eligible for recruitment annually into this study. In a separate study based in Darwin to improve ear health outcomes, 55% of Indigenous women approached in pregnancy have consented to participate in a randomized controlled vaccine study . Using these figures, we could confidently anticipate that approximately 108 eligible Indigenous mothers will agree to participate in our study each year, or 9 per month. This is likely to be an underestimation, as our proposed study is less invasive than the ongoing vaccine trial (which requires immunisation and repeated blood samples).It is anticipated that recruitment will be faster at the Auckland site owing to a larger eligible population. Approximately 580 babies are born each month at Middlemore Hospital, of which 21% are M\u0101ori . Data reported in 2003 showed that about 55% of M\u0101ori pregnant women in NZ were smoking at the time of conception, and 15% of these women quit smoking during their pregnancy From theFigure Participants may be withdrawn from the study if one or more of the following occurs:\u2022 Voluntary withdrawal: A parent or primary caregiver can voluntarily withdraw their infant from the project at any time without having to provide a reason for doing so.\u2022 Failure to meet eligibility criteria: An infant will be withdrawn from the project if their mother/caregiver has previously signed a consent form but they do not meet all the eligibility criteria at the baseline visit (when the infant is five weeks old +/- one week).\u2022 Failure to be located after multiple follow-up home visits\u2022 Death of infant\u2022 Significant illness requiring prolonged hospitalization\u2022 A serious and irreconcilable protocol violation (as determined by the Investigators)In the event that a study participant dies, their family contact will be asked if they require the information recorded to be disposed of as per other participants at the completion of the study, or whether they wish the information to be returned to the family.The design and management of all databases associated with this trial will be undertaken by the data management and information technology groups at the Clinical Trials Research Unit (CTRU), University of Auckland. The databases will be constructed in Oracle. Validation rules for each Case Report Form (CRF) will be specified by the site study managers, in association with the CTRU data manager. These rules will include range checks so that inaccuracies in data collection can be identified early. A query will be raised as soon as any values are entered that are outside the allowed range or if data are missing. The research assistants at each site will amend the CRF's as soon as a query is raised. All information collected from participants will be treated as strictly confidential. De-identified data will be stored in computers under a password secure file. Paper records will be stored under numerical code in a locked filing cabinet within a secure office area, and will only be accesses by approved study staff.An independent person will be appointed to monitor the study conduct. This monitor will audit both Australia and NZ study sites and the CTRU during the trial to ensure that the study protocol is being adhered to.At the study sites the monitor will audit every randomized participant's records to ensure their existence, that they meet the inclusion criteria and have provided written and signed informed consent, and that the NRT is been distributed within the limits of the protocol. The monitor will review the study documentation and records held at each site to ensure that (1) documentation is up-to-date [i.e. correct version of protocol and Manual of Procedures] and (2) record keeping meets the requirements specified in the protocol and complies with regulatory requirements. The monitor will visit each site early on during the study (after ten participants have been randomized), at study close-out and once during the course of the trial. At least 10% of paper copies of the CRF's will be checked for consistency with the electronic records by the monitor. 100% of electronic ARI endpoint data will be checked against source data.The monitor will audit the sites which hold the NRT to check that NRT supply records are in order and that there are sufficient supplies remaining, that the NRT are being stored appropriately and are not being used beyond expiry dates, and that the handling of unused NRT complies with study procedures.A Data Safety and Monitoring Committee will not be established as the trial does not meet any of the criteria stipulated by Ellenburg et al. (2002) for setting up such a Committee .a priori in a statistical analysis plan prepared by the study statistician . No planned interim analyses will be undertaken of the outcome data. A baseline data paper will be prepared after all baseline data for both countries has been collected. The number of episodes of ARI experienced after the intervention for each group will be analysed on an \"intention to treat\" basis. Each of the primary and secondary outcome variables will be examined separately. There are no plans to combine outcome variables into composite variables. Data will be analysed for each country separately and combined. All ETS exposure variables will be treated and examined as outcome variables, rather than as co-variates of the primary outcome variable. Intra-rater and inter-country agreement for grading of the primary outcome assessment will be assessed using the Kappa statistic (unweighted), with 95% confidence intervals for the kappa statistic calculated using the method described by Altman [Statistical analyses will be performed by statisticians at the CTRU. The statistical unit at Menzies School of Health Research (Menzies) will play an advisory role. Data from the trial will be entered into an Oracle database at the CTRU, and then extracted into SAS version 9.2 (SAS Institute Inc. Cary NC), and R version 2.8.1  for analysis. Data analyses will be specified y Altman .All known potential confounders will be measured at baseline, including mother/caregiver's smoking status (and stage of change), education level, marital status, breastfeeding status, smoking status of partner and other household members, crowding, and exposure of infant to other sources of environmental smoke . Thus, comparisons of the intervention and control groups will be performed both unadjusted and adjusted for these known confounders. This second adjusted analysis will control for any maldistribution after randomisation of the confounders between the two groups.Analysis of the primary outcome will involve comparing the rate of respiratory illness between the two groups. Simple unadjusted rates, relative risks and 95% confidence intervals will be obtained in the first instance, with subsequent multiple regression analysis adjusting for other variables. Two forms of regression analysis will be considered for the primary outcome: poisson regression analysis and negative binomial if there is evidence of overdispersion or underdispersion. Analysis of secondary outcomes will be conducted using standard statistical procedures applicable to categorical or continuous data. A per-protocol analysis will also be performed in order to check the robustness of the results. All tests of significance will be two-tailed.For treatment effects, sensitivity analyses will be carried out to determine the effect of missing data.The study will be conducted in accordance with the Australian National Health and Medical Research Council Guidelines on 'Ethical Matters in Aboriginal and Torres Strait Islander Health Research in Australia' . In AustProject Managers will be responsible for the day to day management of the trial, one in Darwin and the other in Auckland. The Project Managers' responsibilities include the development of Standard Operating Procedures, maintaining an up-to-date collection of essential documents (in line with GCP requirements), monitoring recruitment rates, attending to participant queries or concerns and managing the fieldwork staff.Two IHWs in each country will be responsible for recruiting participants into the study and for delivering the 'intervention' program, as well as collecting process evaluation data. The development of Indigenous research workforce capacity is a vital aspect of this trial. Research assistants will collect urine samples and administer the face-to-face questionnaire to participants. They will also be responsible for data entry and data cleaning, and together with the IHWs, ensure that participant follow-up appointments are completed during the scheduled window periods.Two clinical investigators in Darwin and Auckland will review participating infants' clinical notes and code the clinical outcome data.Exposure to ETS is a strong but potentially preventable contributor to respiratory illness among young Indigenous children, when household ETS exposure of children is at its peak. Interventions aimed at encouraging smoking cessation as well as reducing exposure of Indigenous children to ETS have the potential for significant benefits for Indigenous communities. This community-based, international trial has been designed to provide high-quality evidence of the efficacy of a theoretically and culturally sound, intensive family-centred tobacco control program to reduce ETS exposure among Indigenous peoples and so reduce the burden of ARI. As such, it will make a valuable contribution to future updates of the Cochrane review of family and carer smoking control programmes for reducing children's exposure to environmental tobacco smoke. The inclusion of a process evaluation as part of the study will inform the progress and shed additional light on the outcomes of the trial. Finally, this study seeks to incorporate Indigenous models of health to inform the design of the intervention and recruitment methods, and emphasizes Indigenous capacity building at all levels.ARI: Acute respiratory illness; ETS: Environmental tobacco smoke; sometimes referred to as second hand smoke. Usually refers to cigarette smoke in the environment of people who do not smoke; CTRU: Clinical Trials Research Unit; Auckland, NZ; IHW: Indigenous health worker - either Aboriginal or Torres Strait Islander or M\u0101ori; Menzies: Menzies School of Health Research, Darwin, Australia; NRT: Nicotine replacement therapy, available in a range of forms such as patch, gum lozenges, tablets and nasal spray. In this research study, NRT will be dispensed in the form of nicotine patches and/or gum only.The authors declare that they have no competing interests.VJ is an Australian Investigator. She contributed to the study design and drafted the first version of the study protocol. She has led the development of the intervention program, the questionnaires and the study set-up in Australia. NW is the Principal Investigator for this trial in NZ. She contributed to developing and writing the final version of the study protocol. She has contributed to the development of the study questionnaires and has led the study set-up in NZ. DT is the Principal Investigator for the trial in Australia. He contributed to the study design and drafting of the study protocol. MG is a M\u0101ori health researcher in NZ, and a co-investigator on this study. She was instrumental in developing the culturally appropriate intervention program and contributed to the development of the final study protocol. She led the consultative process with M\u0101ori and assisted with the recruitment and training of the M\u0101ori IHWs and research assistants. AC is an Australian Investigator. She originally conceived of the study and contributed to the study design. CB is a NZ Investigator and contributed to developing and writing the final version of the study protocol, especially in relation to the definition of the primary outcome. PM is an Australia Investigator. He contributed to the conception and design of the study. NB is an Aboriginal health researcher and an Australian Co-investigator. She contributed to the study design, particularly in relation to developing a culturally appropriate intervention and in providing advice on recruitment and retention of Indigenous families in Darwin. SV is a NZ Investigator. He is the trial statistician, and contributed to the protocol in matters relating to randomisation, study power and statistical analyses. RB is an Australian Investigator and contributed to the development of the questionnaire to assess the secondary outcomes for the study. CS is an Australian Investigator and contributed to the conception of the study. She also provided expert input initially into the questionnaire design. KE is an Australian Investigator and contributed to the development of the intervention program and provided advice on recruitment and retention of Indigenous families in Darwin. TM is an Australian Investigator and contributed to the development of the intervention program and training of the Australian IHWs. DF is a NZ Investigator. She contributed to the study protocol, the development of the intervention program, and advice on recruitment and retention of Indigenous families in South Auckland. KE is an Australian Investigator and contributed to the development of the intervention program and provided advice on recruitment and retention of Indigenous families in Darwin.  All authors have provided critical review of this manuscript and have approved the final protocol.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2458/10/114/prepubCase Definitions for Acute Respiratory Infection. A table providing full definitions of acute respiratory infection for this studyClick here for file", "texts": ["Acute respiratory illness (ARI) is the most common cause of acute presentations and hospitalisations of young Indigenous children in Australia and New Zealand (NZ). Environmental tobacco smoke (ETS) from household smoking is a significant and preventable contributor to childhood ARI. This paper describes the protocol for a study which aims to test the efficacy of a family-centred tobacco control program about ETS to improve the respiratory health of Indigenous infants in Australia and New Zealand. For the purpose of this paper 'Indigenous' refers to Australia's Aboriginal and Torres Strait Islander peoples when referring to Australian Indigenous populations. In New Zealand, the term 'Indigenous' refers to M\u0101ori.This study will be a parallel, randomized, controlled trial. Participants will be Indigenous women and their infants, half of whom will be randomly allocated to an 'intervention' group, who will receive the tobacco control program over three home visits in the first three months of the infant's life and half to a control group receiving 'usual care' (i.e. they will not receive the tobacco control program). Indigenous health workers will deliver the intervention, the goal of which is to reduce or eliminate infant exposure to ETS. Data collection will occur at baseline (shortly after birth) and when the infant is four months and one year of age. The primary outcome is a doctor-diagnosed, documented case of respiratory illness in participating infants.Interventions aimed at reducing exposure of Indigenous children to ETS have the potential for significant benefits for Indigenous communities. There is currently a dearth of evidence for the effect of tobacco control interventions to reduce children's exposure to ETS among Indigenous populations. This study will provide high-quality evidence of the efficacy of a family-centred tobacco control program on ETS to reduce respiratory illness. Outcomes of our study will be important and significant for Indigenous tobacco control in Australia and New Zealand and prevention of respiratory illness in children.Australian New Zealand Clinical Trials Registry (ACTRN12609000937213) Globally, acute respiratory infections (ARI) cause more deaths and hospitalisations among Indigenous children compared with their age-matched counterparts; the greatest impact is among young children aged 0-4 years . SpecifiWhile there are multiple socioeconomic determinants of ARIs among Indigenous children, environmental tobacco smoke (ETS) exposure is arguably the most readily amenable to modification. The adverse health effects of ETS are well documented, especially its association with respiratory illness. The association between parental smoking and childhood respiratory disease is strongest at younger ages . In chilIn recognition of the damaging health effects of ETS, the World Health Organization (WHO) has prioritised the need to reduce parental smoking as a core component of improving health and development in early childhood . This isDespite the recognition of the adverse child health effects of ETS and the scale of the problem among disadvantaged populations in particular, exposure reduction in homes is a relatively recent area of scientific study . A recenThis study aims to test the efficacy of a culturally appropriate, family-centred tobacco control program about ETS to improve the respiratory health of Indigenous infants in Australia and NZ.Infants (<12 months) of Indigenous mothers/caregivers who receive an intensive family-centred tobacco control program about ETS, compared with 'usual care,' will have fewer health care presentations for respiratory illness.The primary objective of this study is to determine the efficacy of a family-centred tobacco control program about ETS, to reduce health care presentations for respiratory illness in Indigenous infants in the first year of life. Secondary objectives include assessment of the effect of such a program on a range of measures of infant ETS exposure, including mother/caregiver's self-report of infant exposure to ETS and implementation of smoking restrictions in the home and/or car, infant urinary cotinine, household smoking status, mother/caregiver's smoking cessation and quit attempts. A process evaluation of the family-centred tobacco control program will also be undertaken.This study will be a parallel, randomized controlled study with allocation concealed from the study researchers. Participants will be randomly allocated to one of two study arms: the 'intervention' group who will receive the tobacco control program about ETS exposure over three home visits in the first three months of the infant's life, or the control group who will receive 'usual care' (i.e. they will not receive the tobacco control program). IHWs will be trained to deliver the intervention program, the goal of which is to reduce or eliminate exposure of infants to ETS. Data collection will occur at baseline (shortly after birth), and when the infant is four months and one year of age. The primary outcome of interest is the rate of health care presentations for doctor-diagnosed respiratory illness. Figure This study will be conducted in Darwin City and the Greater Darwin area in the Northern Territory, Australia; and within the Counties Manukau District Health Board region, Manukau City, NZ. The target populations for this study are Indigenous families who reside in these two geographical areas. The sampling unit is Indigenous newborn infants and their mothers/primary caregivers (aged 16 years and over).Infants will be eligible for inclusion if:\u2022 They are aged between 0-5 weeks. \u2022 Their mother/caregiver is Indigenous .\u2022 Their mother/caregiver is aged 16 years or over.\u2022 Their mother/caregiver currently smokes or the infant lives in a household where there is at least one other person who smokes (defined as smoking at least weekly).\u2022 Their mother/caregiver plans to reside permanently with the infant in Darwin or Greater Darwin areas of Australia or within the Counties Manukau District Health Board region, Manukau, NZ.\u2022 Their mother/caregiver has given signed written consent to participate in this research study.\u2022 Their mother/caregiver has given signed written consent for study staff to access the infant's health records.\u2022 They are a singleton or the first born in a multiple pregnancy delivery.\u2022 Their mother/caregiver speaks English and/or M\u0101ori.Infants will be excluded from the trial if:\u2022 They have serious neonatal respiratory complications .\u2022 They have other serious neonatal complications .\u2022 They have major organ abnormalities .The above exclusion criteria are because these infants will be given intense interventions to reduce ETS exposure regardless. Infants will also be excluded if:\u2022 Their mother/caregiver has previously been recruited in this research study.\u2022 They live in the same household as a mother/caregiver who has previously been recruited in this study.Participants will be randomized by computer with stratification using permuted blocks by country  and infant age . This will ensure a balance in these key prognostic indicators between the intervention and control groups. All participants (i.e. the infants) will be assigned a unique registration number allocated by a central computer following the submission of their details on a web-based form.This is an assessor blinded trial, with only the study researchers assigning the major primary and secondary outcome measures and trial statisticians blinded to group assignment. Research assistants, who will be responsible for collecting the minor outcome measures will accompany the health workers to the participants' homes for all visits and thus cannot be blinded. The primary outcome will however be a double-blinded measure.Globally, Indigenous notions of health and illness are generally defined more broadly than a Western biomedical definition that focuses more often on physical health or the absence of disease . In AustIn this study, the intervention program about ETS will be framed around an Indigenous model of health promotion, which attends to the psychological, physical, spiritual and cultural wellbeing of the individual and the family/community, as it relates to this project. In NZ, Te Whare Tapa Wha will be used. This model has been applied to understanding M\u0101ori smoking cessation behaviour  and for Participants will be told that they will be randomly assigned to a group that receives 'usual care', or a group that receives extra home visits by an IHW, and that a variety of study measurements will be taken over a 12-month period.Treatment group: The intervention program will (i) provide information and education about the health effects of ETS exposure and use behavioural 'coaching' techniques to help mothers/caregivers and family members implement strategies to reduce the infant's ETS exposure, as well as (ii) identify the smokers among other household members and deliver culturally appropriate smoking cessation advice, counselling and treatment options as requested. An eight weeks supply of free nicotine replacement therapy (NRT) (patches or gum) will be available to participants and other household members for whom such drug therapy is indicated . NRT will be provided by the IHW with appropriate counselling and follow-up. Furthermore, for those that are interested a fax referral to Quitline will be offered, with proactive call back by Quitline.\u2022 The intervention program will be delivered during three face-to-face home visits (of approximately 45-60 minutes) conducted over the first three months of the infant's life. Culturally appropriate resources  will be used to assist in both education and behavioural 'coaching'. These resources will be obtained from relevant health groups in each country who hold a repository of such resources . IHWs will deliver the program after appropriate training, and will complete standardised progress reports after each program session, which will be used at a weekly team meeting with the health workers and study personnel for discussion and ongoing training.Control group: The control group will receive 'usual' care through their community health provider. Usual care entails routine visits to maternal and child health providers at several defined time points during the first 12 months of the infant's life. At these postnatal visits, health providers check developmental milestones and general wellbeing. Additionally, mothers/caregivers routinely receive messages about smoking cessation and ETS exposure in their homes during these visits as part of general health promotion.\u2022 In addition to the above, the IHWs will briefly check that both groups have received the 'usual' care delivered to new mothers and their infants through routine 'well baby' visits in the first 12 months of life through their standard health provider . This will be undertaken at baseline, when the infant is four months and one year of age. The focus will be on key health promotion messages that should have been delivered at routine community health visits  Mothers/caregivers will be given a few key messages if they have not received this information, e.g. clear face, sleep on back for SIDS prevention. If these visits have not been attended or if the key messages have not been received by the mothers/caregivers, they will be referred back to their usual maternal and child health provider.Rate of health provider presentations for new primary episodes of ARI in the first year of life.Primary Outcome: All participating infants will be evaluated at baseline and when the infant is four and 12 months old, for the occurrence of medically attended acute respiratory illnesses (MAARI). These are defined as new onset events, including a change from the child's baseline medical status, referable to the upper and/or lower respiratory tracts. To identify episodes of ARI mothers/caregivers will be asked at baseline, and when the infant is four and 12 months old, whether their child has had any presentation to the clinic or hospital and the names of the clinics attended. Research assistants will collect the source data relevant to the primary outcome measures, so will review the individual child's health provider and hospital clinic records . Source documents will be photocopied, de-identified, labeled with the participant registration, and stored with the trial records. Two clinicians at each study centre will review the records and confirm documented respiratory illnesses without knowing the group allocation of the individual children. MAARI events will be evaluated by these clinicians to determine whether they are medically-attended upper respiratory infection (URI), lower respiratory infection (LRI) and/or otitis media infection .\u25aa Mother/caregiver's self-report of smoking restrictions in the home and car.\u25aa Mother/caregiver's self-report of smoking cessation: defined as mother/caregiver not smoking a single cigarette (not even a puff), in the preceding seven days. We will also be assessing prolonged abstinence .\u25aa Mother/caregiver's self-report of number quit attempts: defined as not smoking a cigarette for at least 24 hours.\u25aa Process evaluation indicators: a mix of quantitative and qualitative measures to assess how well the intervention program was implemented according to protocol e.g. number of 'coaching' activities completed, obstacles and successes in delivering program, parent satisfaction with the program.\u25aa A total sample size of 190 provides 90% power (5% significance) to detect a 25% reduction of new episodes of respiratory illness (primary outcome) in the intervention group compared to the control group. This is based on a conservative estimate of an average of 3 health provider visits per year in the control group, compared to an average of 2.25 visits in the intervention group . There are few published data on the community burden of ARIs in Northern Territory Indigenous children or NZ M\u0101ori children. In a recent study of disease burden and clinic attendances for young Indigenous children in two remote Northern Territory communities, the median number of presentations for upper respiratory illness in the first year of life was 7.5 (interquartile range 4-11) and for lower respiratory illness, 2.5 (interquartile range 1-5) . The oveIn Australia and NZ, mothers/caregivers will be approached for recruitment into the study through a range of community, Indigenous-controlled health and government hospital services. We will approach both pregnant women and new mothers to ascertain their interest in participating in the trial. If pregnant women are interested in the study, we will re-approach them after they have given birth. Eligible and interested mothers will be asked for their consent for randomization. Documented written consent will be obtained from all participants prior to entering the study. A range of project-specific advertising material will be produced  and local Indigenous media may be used to bolster recruitment.In 2006, there were approximately 240 Indigenous infants born to mothers who were resident in Darwin, Australia. We anticipate that 90% or 216 Indigenous infants/mothers will be eligible for recruitment annually into this study. In a separate study based in Darwin to improve ear health outcomes, 55% of Indigenous women approached in pregnancy have consented to participate in a randomized controlled vaccine study . Using these figures, we could confidently anticipate that approximately 108 eligible Indigenous mothers will agree to participate in our study each year, or 9 per month. This is likely to be an underestimation, as our proposed study is less invasive than the ongoing vaccine trial (which requires immunisation and repeated blood samples).It is anticipated that recruitment will be faster at the Auckland site owing to a larger eligible population. Approximately 580 babies are born each month at Middlemore Hospital, of which 21% are M\u0101ori . Data reported in 2003 showed that about 55% of M\u0101ori pregnant women in NZ were smoking at the time of conception, and 15% of these women quit smoking during their pregnancy From theFigure Participants may be withdrawn from the study if one or more of the following occurs:\u2022 Voluntary withdrawal: A parent or primary caregiver can voluntarily withdraw their infant from the project at any time without having to provide a reason for doing so.\u2022 Failure to meet eligibility criteria: An infant will be withdrawn from the project if their mother/caregiver has previously signed a consent form but they do not meet all the eligibility criteria at the baseline visit (when the infant is five weeks old +/- one week).\u2022 Failure to be located after multiple follow-up home visits\u2022 Death of infant\u2022 Significant illness requiring prolonged hospitalization\u2022 A serious and irreconcilable protocol violation (as determined by the Investigators)In the event that a study participant dies, their family contact will be asked if they require the information recorded to be disposed of as per other participants at the completion of the study, or whether they wish the information to be returned to the family.The design and management of all databases associated with this trial will be undertaken by the data management and information technology groups at the Clinical Trials Research Unit (CTRU), University of Auckland. The databases will be constructed in Oracle. Validation rules for each Case Report Form (CRF) will be specified by the site study managers, in association with the CTRU data manager. These rules will include range checks so that inaccuracies in data collection can be identified early. A query will be raised as soon as any values are entered that are outside the allowed range or if data are missing. The research assistants at each site will amend the CRF's as soon as a query is raised. All information collected from participants will be treated as strictly confidential. De-identified data will be stored in computers under a password secure file. Paper records will be stored under numerical code in a locked filing cabinet within a secure office area, and will only be accesses by approved study staff.An independent person will be appointed to monitor the study conduct. This monitor will audit both Australia and NZ study sites and the CTRU during the trial to ensure that the study protocol is being adhered to.At the study sites the monitor will audit every randomized participant's records to ensure their existence, that they meet the inclusion criteria and have provided written and signed informed consent, and that the NRT is been distributed within the limits of the protocol. The monitor will review the study documentation and records held at each site to ensure that (1) documentation is up-to-date [i.e. correct version of protocol and Manual of Procedures] and (2) record keeping meets the requirements specified in the protocol and complies with regulatory requirements. The monitor will visit each site early on during the study (after ten participants have been randomized), at study close-out and once during the course of the trial. At least 10% of paper copies of the CRF's will be checked for consistency with the electronic records by the monitor. 100% of electronic ARI endpoint data will be checked against source data.The monitor will audit the sites which hold the NRT to check that NRT supply records are in order and that there are sufficient supplies remaining, that the NRT are being stored appropriately and are not being used beyond expiry dates, and that the handling of unused NRT complies with study procedures.A Data Safety and Monitoring Committee will not be established as the trial does not meet any of the criteria stipulated by Ellenburg et al. (2002) for setting up such a Committee .a priori in a statistical analysis plan prepared by the study statistician . No planned interim analyses will be undertaken of the outcome data. A baseline data paper will be prepared after all baseline data for both countries has been collected. The number of episodes of ARI experienced after the intervention for each group will be analysed on an \"intention to treat\" basis. Each of the primary and secondary outcome variables will be examined separately. There are no plans to combine outcome variables into composite variables. Data will be analysed for each country separately and combined. All ETS exposure variables will be treated and examined as outcome variables, rather than as co-variates of the primary outcome variable. Intra-rater and inter-country agreement for grading of the primary outcome assessment will be assessed using the Kappa statistic (unweighted), with 95% confidence intervals for the kappa statistic calculated using the method described by Altman [Statistical analyses will be performed by statisticians at the CTRU. The statistical unit at Menzies School of Health Research (Menzies) will play an advisory role. Data from the trial will be entered into an Oracle database at the CTRU, and then extracted into SAS version 9.2 (SAS Institute Inc. Cary NC), and R version 2.8.1  for analysis. Data analyses will be specified y Altman .All known potential confounders will be measured at baseline, including mother/caregiver's smoking status (and stage of change), education level, marital status, breastfeeding status, smoking status of partner and other household members, crowding, and exposure of infant to other sources of environmental smoke . Thus, comparisons of the intervention and control groups will be performed both unadjusted and adjusted for these known confounders. This second adjusted analysis will control for any maldistribution after randomisation of the confounders between the two groups.Analysis of the primary outcome will involve comparing the rate of respiratory illness between the two groups. Simple unadjusted rates, relative risks and 95% confidence intervals will be obtained in the first instance, with subsequent multiple regression analysis adjusting for other variables. Two forms of regression analysis will be considered for the primary outcome: poisson regression analysis and negative binomial if there is evidence of overdispersion or underdispersion. Analysis of secondary outcomes will be conducted using standard statistical procedures applicable to categorical or continuous data. A per-protocol analysis will also be performed in order to check the robustness of the results. All tests of significance will be two-tailed.For treatment effects, sensitivity analyses will be carried out to determine the effect of missing data.The study will be conducted in accordance with the Australian National Health and Medical Research Council Guidelines on 'Ethical Matters in Aboriginal and Torres Strait Islander Health Research in Australia' . In AustProject Managers will be responsible for the day to day management of the trial, one in Darwin and the other in Auckland. The Project Managers' responsibilities include the development of Standard Operating Procedures, maintaining an up-to-date collection of essential documents (in line with GCP requirements), monitoring recruitment rates, attending to participant queries or concerns and managing the fieldwork staff.Two IHWs in each country will be responsible for recruiting participants into the study and for delivering the 'intervention' program, as well as collecting process evaluation data. The development of Indigenous research workforce capacity is a vital aspect of this trial. Research assistants will collect urine samples and administer the face-to-face questionnaire to participants. They will also be responsible for data entry and data cleaning, and together with the IHWs, ensure that participant follow-up appointments are completed during the scheduled window periods.Two clinical investigators in Darwin and Auckland will review participating infants' clinical notes and code the clinical outcome data.Exposure to ETS is a strong but potentially preventable contributor to respiratory illness among young Indigenous children, when household ETS exposure of children is at its peak. Interventions aimed at encouraging smoking cessation as well as reducing exposure of Indigenous children to ETS have the potential for significant benefits for Indigenous communities. This community-based, international trial has been designed to provide high-quality evidence of the efficacy of a theoretically and culturally sound, intensive family-centred tobacco control program to reduce ETS exposure among Indigenous peoples and so reduce the burden of ARI. As such, it will make a valuable contribution to future updates of the Cochrane review of family and carer smoking control programmes for reducing children's exposure to environmental tobacco smoke. The inclusion of a process evaluation as part of the study will inform the progress and shed additional light on the outcomes of the trial. Finally, this study seeks to incorporate Indigenous models of health to inform the design of the intervention and recruitment methods, and emphasizes Indigenous capacity building at all levels.ARI: Acute respiratory illness; ETS: Environmental tobacco smoke; sometimes referred to as second hand smoke. Usually refers to cigarette smoke in the environment of people who do not smoke; CTRU: Clinical Trials Research Unit; Auckland, NZ; IHW: Indigenous health worker - either Aboriginal or Torres Strait Islander or M\u0101ori; Menzies: Menzies School of Health Research, Darwin, Australia; NRT: Nicotine replacement therapy, available in a range of forms such as patch, gum lozenges, tablets and nasal spray. In this research study, NRT will be dispensed in the form of nicotine patches and/or gum only.The authors declare that they have no competing interests.VJ is an Australian Investigator. She contributed to the study design and drafted the first version of the study protocol. She has led the development of the intervention program, the questionnaires and the study set-up in Australia. NW is the Principal Investigator for this trial in NZ. She contributed to developing and writing the final version of the study protocol. She has contributed to the development of the study questionnaires and has led the study set-up in NZ. DT is the Principal Investigator for the trial in Australia. He contributed to the study design and drafting of the study protocol. MG is a M\u0101ori health researcher in NZ, and a co-investigator on this study. She was instrumental in developing the culturally appropriate intervention program and contributed to the development of the final study protocol. She led the consultative process with M\u0101ori and assisted with the recruitment and training of the M\u0101ori IHWs and research assistants. AC is an Australian Investigator. She originally conceived of the study and contributed to the study design. CB is a NZ Investigator and contributed to developing and writing the final version of the study protocol, especially in relation to the definition of the primary outcome. PM is an Australia Investigator. He contributed to the conception and design of the study. NB is an Aboriginal health researcher and an Australian Co-investigator. She contributed to the study design, particularly in relation to developing a culturally appropriate intervention and in providing advice on recruitment and retention of Indigenous families in Darwin. SV is a NZ Investigator. He is the trial statistician, and contributed to the protocol in matters relating to randomisation, study power and statistical analyses. RB is an Australian Investigator and contributed to the development of the questionnaire to assess the secondary outcomes for the study. CS is an Australian Investigator and contributed to the conception of the study. She also provided expert input initially into the questionnaire design. KE is an Australian Investigator and contributed to the development of the intervention program and provided advice on recruitment and retention of Indigenous families in Darwin. TM is an Australian Investigator and contributed to the development of the intervention program and training of the Australian IHWs. DF is a NZ Investigator. She contributed to the study protocol, the development of the intervention program, and advice on recruitment and retention of Indigenous families in South Auckland. KE is an Australian Investigator and contributed to the development of the intervention program and provided advice on recruitment and retention of Indigenous families in Darwin.  All authors have provided critical review of this manuscript and have approved the final protocol.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2458/10/114/prepubCase Definitions for Acute Respiratory Infection. A table providing full definitions of acute respiratory infection for this studyClick here for file"]}
{"representative": "Physical activity (PA) rates decline precipitously during the high school years and are consistently lower among adolescent girls than adolescent boys. Due to cultural barriers, this problem might be exacerbated in female Iranian adolescents. However, little intervention research has been conducted to try to increase PA participation rates with this population. Because PA interventions in schools have the potential to reach many children and adolescents, this study reports on PA intervention research conducted in all-female Iranian high schools.A randomized controlled trial was conducted to examine the effects of two six-month tailored interventions on potential determinants of PA and PA behavior. Students (N = 161) were randomly allocated to one of three conditions: an intervention based on Pender's Health Promotion model (HP), an intervention based on an integration of the health promotion model and selected constructs from the Transtheoretical model (THP), and a control group (CON). Measures were administered prior to the intervention, at post-intervention and at a six-month follow-up.Repeated measure ANOVAs showed a significant interaction between group and time for perceived benefits, self efficacy, interpersonal norms, social support, behavioral processes, and PA behavior, indicating that both intervention groups significantly improved across the 24-week intervention, whereas the control group did not. Participants in the THP group showed greater use of counter conditioning and stimulus control at post-intervention and at follow-up. While there were no significant differences in PA between the HP and CON groups at follow-up, a significant difference was still found between the THP and the CON group.This study provides the first evidence of the effectiveness of a PA intervention based on Pender's HP model combined with selected aspects of the TTM on potential determinants to increase PA among Iranian high school girls. Regular physical activity (PA) has a beneficial effect on overall health  and is iThe physiological and psychosocial changes experienced during the high school years may make adolescence a particularly high-risk period for girls to adopt sedentary habits . HoweverTheory-based research is necessary to conduct school-based interventions and one potentially useful theory is Pender's Health Promotion Model (HPM). This model is derived from Bandura's Social Cognitive Theory (SCT)  and inclOf particular interest to the current research, competing preferences are viewed as alternative behaviors  with powerful reinforcing properties over which individuals exert a relatively high level of control. They are last-minute urges based on one's preference hierarchy that can derail a plan of action for positive health action. For example, \"giving in\" to a competing preference might include watching television or playing computer games rather than being physically active. Individuals vary in their ability to sustain attention and avoid disruption of health behaviors but in general, the inhibition of competing preferences requires the exercise of control capabilities. In the HPM, competing preferences are proposed to directly affect the probability of occurrence of behavior as well as moderating the effect of commitment .Another model that can be applied to this research area is the transtheoretical model of behavior change (TTM), which includes the stages of change that a person moves through when adopting a behavior and the processes of change used in the stages to help in the adoption of a new behavior. The framework proposes that individuals move through a temporal sequence of five stages: pre-contemplation , contemplation , preparation , action , and maintenance (active for more than 6 months) . Marcus As no single theory can account for all complexities associated with behavior change, integration across major theories is recommended in research . TherefoResearchers have identified the importance of designing targeted interventions that address the needs of specific populations. Due to cultural barriers that prevent Iranian women from exercising in public places and do not encourage PA in general, research is needed to establish ways to help adolescent Iranian females to develop and sustain active lifestyles. Therefore, the purpose of this study was to evaluate the post-intervention and six month follow-up effects of a tailored PA intervention for Iranian adolescent girls based on the Pender's health promotion model (HPM) and selected constructs from the transtheoretical model (TTM), using a randomized control trial within schools as the medium for the intervention. Three groups were included in the study: an HPM intervention group with HPM interventions addressing stages of behavior change, an HPM with two TTM processes added group (THP), and a control group who received their usual PE program. The main study hypothesis was that the integrated model would result in improved PA maintenance. It was further hypothesized that the THP group would result in greater increases in PA-related cognitions and PA participation compared to the HPM only group.All three groups completed questionnaires prior to the start of the interventions, immediately following the intervention, and six months after the end of the interventions. The research was approved by the Tarbiat Modares University ethics board and the appropriate educational authorities. Prior to participation, investigators sent a written information sheet and consent form for the parents and participants to sign.Participants came from three, all female, Iranian, public secondary schools that were randomly selected using a random number table from a possible 31 schools in the area. All selected schools chose to participate. The teachers were all female and all schools were from the same socioeconomic background. Participants within the schools were eligible for inclusion in this study if they were in the preparation stage of exercise behavior change at baseline and were in grades nine or ten . This inclusion criterion was used because it is participants in the preparation stage who are recommended for recruitment to exercise programs as they are most likely to benefit . FurtherAll the instruments were translated into Persian by a bilingual researcher and then validated using standard back translation technique  by a natIntervention study questionnaires were administered by the researcher to students in their classrooms. The investigator remained in the room during questionnaire administration and answered any questions. For each of the next six consecutive days following questionnaire administration (Saturday through Thursday) each participant completed a child/adolescent/activity log (CAAL) .Stage of change was assessed using an adapted two question measure . In the Perceived self-efficacy was adapted from an existing exercise self-efficacy scale . This scPA was assessed using a modified child/adolescent activity log (CAAL) . The CAAs = .76 to .77, P < 0.001).The discriminant validity of the log in this study was supported by the stages of change. As expected, those adolescents who were in later stages  reported more minutes of PA (M = 62.88 min \u00b1 27.05 min) than those in earlier stages  . Furthermore, stage of change and total number of minutes and mean of minutes activity per week on the CAAL were significantly correlated  which included 18 items measuring both benefits  and barriers . Each item was measured on a 4-point Likert scale ranging from 1  to 4 (very true) . The meaThree subscales developed by Garcia and colleagues  were usePA preferences were measured by a scale based on Pender's instrument for measuring variables in the health promotion model . The 9-iCounter conditioning  and stimulus control  process of change questions were adapted from a questionnaire developed by Marcus and colleagues . IndividThe various components of the interventions, the timeline, constructs targeted and educational methods used are outlined in Table The THP group also received education on the two processes of change: counter conditioning and stimulus control. The counter conditioning education included information on walking or bicycling to school or the store instead of using the bus, getting on or off the bus several blocks away from the destination, taking the stairs instead of the elevator, and taking fitness break by walking or doing desk exercises instead of taking a sedentary coffee break. The stimulus control training included tips on how to change one's environment by posting motivating messages and by removing things in the environment that contribute to inactivity. The control group received no educational or counseling sessions but did receive the educational pamphlets after administration of the final follow-up questionnaires.In addition to the educational sessions, each participant from the two intervention groups received a 20 to 25 minute individual counseling session based on personal responses to the questionnaire at baseline, and at the fourth, tenth, and eighteenth weeks of the intervention. These counseling sessions helped the participants to set and review personal PA goals, to determine strategies to overcome barriers to PA, and to review her social network. Each participant was also provided with a reminder card of her goals and asked to display the card in a suitable place at home or in her school notebook.th week (68% participation) and one at the 18th week (71% participation) of the intervention were held with the participants' mothers to help the mothers understand the benefits of PA, to highlight the importance of social support, and to help them when they tried to help their daughters reach their PA goals. Further, during the 22nd week of the intervention, each participant was telephoned by the researcher to encourage the participant to maintain her PA and to further discuss her PA goals. During the last week of the intervention the participants went mountaineering with their mothers and teachers, a popular means to be active in Iran, to further encourage PA and social support in the participants.Teachers in the two intervention schools attended sessions aimed at educating them about the intervention models and the importance of social support and modeling. This was done so the teachers could provide role modeling by doing exercise in the schools and could also provide support to help the participants to reach their PA goals. Two 60 minute sessions, one at the 102. For all analyses alpha levels were set at p < 0.05.The analyses were conducted with the Statistical Package for the Social Sciences (SPSS), version 15.0. Variables were assessed for normality of distribution and logarithmic transformations were performed on self-efficacy, social support and mean PA whereas square root transformations were performed on perceived barriers, stimulus control and preferences. Where assumptions of homogeneity of variance and sphericity could not be satisfied, non-parametric tests were used. At post-test and follow-up, stages of readiness to change PA behavior were merged into two categories: pre-action  and action (action and maintenance). This decision was made because at follow-up 40 percent of cells had an expected count of less than five. Although there was not a similar limitation at post-intervention, groups were also collapsed at that time so that equivalent analyses could be conducted. Chi-square tests were used to compare these categories between the three groups at post-intervention and follow-up. Progression in the stages through the time points for the three groups was compared using the Friedman test. Changes in outcome variables from baseline through post intervention and follow-up were assessed by a repeated measure ANOVA to determine differences between intervention groups. Where significant interactions were found, follow-up univariate analyses of covariance (ANCOVA) were conducted to reveal main effects. In these analyses the baseline measures were included as the covariate with the follow-up variable as the dependent variable. All post hoc tests were performed with adjustment for multiple comparisons and intervention effect sizes were calculated using Partial \u03b7X2 (4) = 51.61, p = 0.001, and at follow-up, X2(4) = 20.2, p = 0.001. There was a statistically significant increase in the number of participants in both THP and HP groups who progressed through the stages from baseline to follow-up (Friedman X2 (2) = 49.6, 2 p < .001, and X2 (2) = 43.1, p = 0 .001), whereas limited progression occurred in the control group (X2 (2) = 1.90, p = .38). At the six-month follow-up the THP group had a larger percentage of participants in the action stages than the HP group. The percentage of participants in each stage at posttest and follow-up is summarized in Table Demographic characteristics at baseline are summarized in Table p = .000, \u03b72 = .16, stimulus control, F = 14.82, p = .000, \u03b72 = .15, overall minutes PA per week, F = 31.50, p = .000, \u03b72 = .29 and mean minutes PA per day, F = 39.94, p = .000, \u03b72 = .34. It was noted that the assumption of homogeneity of variance was not met for stimulus control, counter conditioning and mean PA per day. However, equivalent non-parametric analyses revealed similar significant results. Post hoc analyses showed that the differences for counter conditioning and stimulus control were not significant between the THP and HP groups but there were significant differences between the two intervention groups and the control group (p = .003 \u2013 .006).Table p = .001, stimulus control, F = 14.02, p = .04, overall minutes PA per week, F = 4.32, p = .01, and mean minutes PA per day, F = 5.0, p = .008. At follow-up, results showed no significant differences between the THP and HP groups for any of above outcomes except stimulus control p = .02, but the two intervention groups and the control group differed for both behavioral processes (p = .000 \u2013 .02). No significant differences were found between the HP and control group for overall minutes and mean of PA.There was no significant difference between the THP and HP groups for overall and mean PA minutes. However, students in both intervention groups reported significantly more PA than students in the control group. Main effects tests by group at follow-up, controlling for the differences in baseline values, found significant differences for counter conditioning, F = 7.83, p = .000) and a decrease between post-intervention and follow-up (p = .004). There was also an increase for stimulus control between baseline and follow-up for the THP and HP groups (p = .001 and .004 respectively). Using the same procedure for counter conditioning showed the THP group had a significant increase between baseline, post-intervention (p = .000) and follow-up (p = .04). However, there was a significant decrease in counter conditioning between post-intervention and follow-up (p = .001). Main effects tests for time showed that the two intervention groups had significantly increased their mean PA between baseline and post-intervention (p = .000) and also from baseline to follow-up (p = .000).Main effects for time showed that the THP group had a significant increase for stimulus control between baseline and post-intervention  from the TTM in conjunction within the HPM would result in greater increases in PA related cognitions and PA behavior. This integration of models was hypothesized to address the lack of consideration of environmental influences within the HPM and acknowledges the substantial body of research showing that TTM tailored interventions can promote an individual's progression through stages -37. All As already mentioned, participants in the THP group also reported more PA at post intervention than the HP group, although these differences were not statistically significant. At the end of intervention period both the THP and HP groups reported spending about one hour more in activity per day compared to participants in the control group who increased their activity by only six minutes per day compared to baseline. This finding is likely related to the overall advancement into action stages by participants in both intervention groups because a number of other researchers have found that participants in the action stages reported more PA than those are in the pre-action stages -37. WhilSubstantial relapses in behavior are generally observed in many intervention studies \"when the intensive intervention ends and external supports are withdrawn\" . TherefoA unique aspect of this research was the involvement of the participants' teachers and mothers with the intention of changing cultural norms and providing vicarious learning for the participants through observing important others engaged in PA. As noted in the introduction, the cultural norms for Iranian females to be active are restrictive. Therefore, it may be that by asking the participants' teachers and mothers to encourage the participants to be more active and to express their expectations that the girls be more active, a shift occurred around social norms for the participants within this study. However, it also may be that changes occurred due to peer learning and further research is required to clarify this finding. In general however, this is an extremely encouraging finding that can be used when creating interventions with similar populations.Another important strength of the current study was the duration of the intervention (24 weeks) and the inclusion of follow-up assessments. To achieve significant changes in deeply entrenched behaviors, interventions among adolescents should last longer than one semester . While pThere were several limitations of the present study. First, the data were measured by self-report questionnaire which introduces the possibility of biased results. Another limitation is the assessment of the validity of the CAAL and it is recommended that the CAAL be further validated with an objective measure in Iranian adolescents. It should be noted however, that test-retest reliability of the CAAL in this study was .98. Another limitation is the restriction of these interventions to participants in the preparation stage at baseline. Future research should expand these interventions to include participants at other stages of change at baseline. Such research would also necessitate expanding to other processes of change such as consciousness raising for participants in precontemplation.Outcome evaluation showed a positive short-term effect for the intervention groups on stage of readiness, potential determinants of PA and on amount of PA, as both intervention groups increased their PA by approximately one hour per day. Although participants in the THP group reported using more behavioral processes than those in the HP group, no significant differences were found between the THP and HP groups for PA at the post intervention. However, the THP group recorded more PA and more positive results on most of the potential determinants compared to the control group and therefore appears to be the stronger intervention. At the six month follow-up, PA levels had decreased from posttest and fewer students in both intervention groups were in the action stages of behavior change. However, the significant differences between the HP and control groups for PA were not present at the six-month follow-up, but some differences between the THP and control groups were still present indicating that this was the stronger intervention.Iranian girls face many barriers to an active lifestyle, including lack of suitable places to be active, access to facilities and resources, cultural limitations, and the low importance placed on exercising over other activities such as doing homework or home responsibilities. Therefore, access to equipment and facilities and a supportive environment are important strategies for promoting PA among this group of adolescents . Indeed,The author(s) declare that they have no competing interests.PT participated in the design of the study, performed the statistical analysis and drafted the manuscript. TB participated in the statistical analysis, helped to draft the manuscript, and read the paper critically for theoretical content and interpretation of study findings. DL participated in the sequence alignment and helped to draft the manuscript. SN and FG conceived of the study and participated in its design and coordination. All authors read and approved the final manuscript.", "texts": ["Physical activity (PA) rates decline precipitously during the high school years and are consistently lower among adolescent girls than adolescent boys. Due to cultural barriers, this problem might be exacerbated in female Iranian adolescents. However, little intervention research has been conducted to try to increase PA participation rates with this population. Because PA interventions in schools have the potential to reach many children and adolescents, this study reports on PA intervention research conducted in all-female Iranian high schools.A randomized controlled trial was conducted to examine the effects of two six-month tailored interventions on potential determinants of PA and PA behavior. Students (N = 161) were randomly allocated to one of three conditions: an intervention based on Pender's Health Promotion model (HP), an intervention based on an integration of the health promotion model and selected constructs from the Transtheoretical model (THP), and a control group (CON). Measures were administered prior to the intervention, at post-intervention and at a six-month follow-up.Repeated measure ANOVAs showed a significant interaction between group and time for perceived benefits, self efficacy, interpersonal norms, social support, behavioral processes, and PA behavior, indicating that both intervention groups significantly improved across the 24-week intervention, whereas the control group did not. Participants in the THP group showed greater use of counter conditioning and stimulus control at post-intervention and at follow-up. While there were no significant differences in PA between the HP and CON groups at follow-up, a significant difference was still found between the THP and the CON group.This study provides the first evidence of the effectiveness of a PA intervention based on Pender's HP model combined with selected aspects of the TTM on potential determinants to increase PA among Iranian high school girls. Regular physical activity (PA) has a beneficial effect on overall health  and is iThe physiological and psychosocial changes experienced during the high school years may make adolescence a particularly high-risk period for girls to adopt sedentary habits . HoweverTheory-based research is necessary to conduct school-based interventions and one potentially useful theory is Pender's Health Promotion Model (HPM). This model is derived from Bandura's Social Cognitive Theory (SCT)  and inclOf particular interest to the current research, competing preferences are viewed as alternative behaviors  with powerful reinforcing properties over which individuals exert a relatively high level of control. They are last-minute urges based on one's preference hierarchy that can derail a plan of action for positive health action. For example, \"giving in\" to a competing preference might include watching television or playing computer games rather than being physically active. Individuals vary in their ability to sustain attention and avoid disruption of health behaviors but in general, the inhibition of competing preferences requires the exercise of control capabilities. In the HPM, competing preferences are proposed to directly affect the probability of occurrence of behavior as well as moderating the effect of commitment .Another model that can be applied to this research area is the transtheoretical model of behavior change (TTM), which includes the stages of change that a person moves through when adopting a behavior and the processes of change used in the stages to help in the adoption of a new behavior. The framework proposes that individuals move through a temporal sequence of five stages: pre-contemplation , contemplation , preparation , action , and maintenance (active for more than 6 months) . Marcus As no single theory can account for all complexities associated with behavior change, integration across major theories is recommended in research . TherefoResearchers have identified the importance of designing targeted interventions that address the needs of specific populations. Due to cultural barriers that prevent Iranian women from exercising in public places and do not encourage PA in general, research is needed to establish ways to help adolescent Iranian females to develop and sustain active lifestyles. Therefore, the purpose of this study was to evaluate the post-intervention and six month follow-up effects of a tailored PA intervention for Iranian adolescent girls based on the Pender's health promotion model (HPM) and selected constructs from the transtheoretical model (TTM), using a randomized control trial within schools as the medium for the intervention. Three groups were included in the study: an HPM intervention group with HPM interventions addressing stages of behavior change, an HPM with two TTM processes added group (THP), and a control group who received their usual PE program. The main study hypothesis was that the integrated model would result in improved PA maintenance. It was further hypothesized that the THP group would result in greater increases in PA-related cognitions and PA participation compared to the HPM only group.All three groups completed questionnaires prior to the start of the interventions, immediately following the intervention, and six months after the end of the interventions. The research was approved by the Tarbiat Modares University ethics board and the appropriate educational authorities. Prior to participation, investigators sent a written information sheet and consent form for the parents and participants to sign.Participants came from three, all female, Iranian, public secondary schools that were randomly selected using a random number table from a possible 31 schools in the area. All selected schools chose to participate. The teachers were all female and all schools were from the same socioeconomic background. Participants within the schools were eligible for inclusion in this study if they were in the preparation stage of exercise behavior change at baseline and were in grades nine or ten . This inclusion criterion was used because it is participants in the preparation stage who are recommended for recruitment to exercise programs as they are most likely to benefit . FurtherAll the instruments were translated into Persian by a bilingual researcher and then validated using standard back translation technique  by a natIntervention study questionnaires were administered by the researcher to students in their classrooms. The investigator remained in the room during questionnaire administration and answered any questions. For each of the next six consecutive days following questionnaire administration (Saturday through Thursday) each participant completed a child/adolescent/activity log (CAAL) .Stage of change was assessed using an adapted two question measure . In the Perceived self-efficacy was adapted from an existing exercise self-efficacy scale . This scPA was assessed using a modified child/adolescent activity log (CAAL) . The CAAs = .76 to .77, P < 0.001).The discriminant validity of the log in this study was supported by the stages of change. As expected, those adolescents who were in later stages  reported more minutes of PA (M = 62.88 min \u00b1 27.05 min) than those in earlier stages  . Furthermore, stage of change and total number of minutes and mean of minutes activity per week on the CAAL were significantly correlated  which included 18 items measuring both benefits  and barriers . Each item was measured on a 4-point Likert scale ranging from 1  to 4 (very true) . The meaThree subscales developed by Garcia and colleagues  were usePA preferences were measured by a scale based on Pender's instrument for measuring variables in the health promotion model . The 9-iCounter conditioning  and stimulus control  process of change questions were adapted from a questionnaire developed by Marcus and colleagues . IndividThe various components of the interventions, the timeline, constructs targeted and educational methods used are outlined in Table The THP group also received education on the two processes of change: counter conditioning and stimulus control. The counter conditioning education included information on walking or bicycling to school or the store instead of using the bus, getting on or off the bus several blocks away from the destination, taking the stairs instead of the elevator, and taking fitness break by walking or doing desk exercises instead of taking a sedentary coffee break. The stimulus control training included tips on how to change one's environment by posting motivating messages and by removing things in the environment that contribute to inactivity. The control group received no educational or counseling sessions but did receive the educational pamphlets after administration of the final follow-up questionnaires.In addition to the educational sessions, each participant from the two intervention groups received a 20 to 25 minute individual counseling session based on personal responses to the questionnaire at baseline, and at the fourth, tenth, and eighteenth weeks of the intervention. These counseling sessions helped the participants to set and review personal PA goals, to determine strategies to overcome barriers to PA, and to review her social network. Each participant was also provided with a reminder card of her goals and asked to display the card in a suitable place at home or in her school notebook.th week (68% participation) and one at the 18th week (71% participation) of the intervention were held with the participants' mothers to help the mothers understand the benefits of PA, to highlight the importance of social support, and to help them when they tried to help their daughters reach their PA goals. Further, during the 22nd week of the intervention, each participant was telephoned by the researcher to encourage the participant to maintain her PA and to further discuss her PA goals. During the last week of the intervention the participants went mountaineering with their mothers and teachers, a popular means to be active in Iran, to further encourage PA and social support in the participants.Teachers in the two intervention schools attended sessions aimed at educating them about the intervention models and the importance of social support and modeling. This was done so the teachers could provide role modeling by doing exercise in the schools and could also provide support to help the participants to reach their PA goals. Two 60 minute sessions, one at the 102. For all analyses alpha levels were set at p < 0.05.The analyses were conducted with the Statistical Package for the Social Sciences (SPSS), version 15.0. Variables were assessed for normality of distribution and logarithmic transformations were performed on self-efficacy, social support and mean PA whereas square root transformations were performed on perceived barriers, stimulus control and preferences. Where assumptions of homogeneity of variance and sphericity could not be satisfied, non-parametric tests were used. At post-test and follow-up, stages of readiness to change PA behavior were merged into two categories: pre-action  and action (action and maintenance). This decision was made because at follow-up 40 percent of cells had an expected count of less than five. Although there was not a similar limitation at post-intervention, groups were also collapsed at that time so that equivalent analyses could be conducted. Chi-square tests were used to compare these categories between the three groups at post-intervention and follow-up. Progression in the stages through the time points for the three groups was compared using the Friedman test. Changes in outcome variables from baseline through post intervention and follow-up were assessed by a repeated measure ANOVA to determine differences between intervention groups. Where significant interactions were found, follow-up univariate analyses of covariance (ANCOVA) were conducted to reveal main effects. In these analyses the baseline measures were included as the covariate with the follow-up variable as the dependent variable. All post hoc tests were performed with adjustment for multiple comparisons and intervention effect sizes were calculated using Partial \u03b7X2 (4) = 51.61, p = 0.001, and at follow-up, X2(4) = 20.2, p = 0.001. There was a statistically significant increase in the number of participants in both THP and HP groups who progressed through the stages from baseline to follow-up (Friedman X2 (2) = 49.6, 2 p < .001, and X2 (2) = 43.1, p = 0 .001), whereas limited progression occurred in the control group (X2 (2) = 1.90, p = .38). At the six-month follow-up the THP group had a larger percentage of participants in the action stages than the HP group. The percentage of participants in each stage at posttest and follow-up is summarized in Table Demographic characteristics at baseline are summarized in Table p = .000, \u03b72 = .16, stimulus control, F = 14.82, p = .000, \u03b72 = .15, overall minutes PA per week, F = 31.50, p = .000, \u03b72 = .29 and mean minutes PA per day, F = 39.94, p = .000, \u03b72 = .34. It was noted that the assumption of homogeneity of variance was not met for stimulus control, counter conditioning and mean PA per day. However, equivalent non-parametric analyses revealed similar significant results. Post hoc analyses showed that the differences for counter conditioning and stimulus control were not significant between the THP and HP groups but there were significant differences between the two intervention groups and the control group (p = .003 \u2013 .006).Table p = .001, stimulus control, F = 14.02, p = .04, overall minutes PA per week, F = 4.32, p = .01, and mean minutes PA per day, F = 5.0, p = .008. At follow-up, results showed no significant differences between the THP and HP groups for any of above outcomes except stimulus control p = .02, but the two intervention groups and the control group differed for both behavioral processes (p = .000 \u2013 .02). No significant differences were found between the HP and control group for overall minutes and mean of PA.There was no significant difference between the THP and HP groups for overall and mean PA minutes. However, students in both intervention groups reported significantly more PA than students in the control group. Main effects tests by group at follow-up, controlling for the differences in baseline values, found significant differences for counter conditioning, F = 7.83, p = .000) and a decrease between post-intervention and follow-up (p = .004). There was also an increase for stimulus control between baseline and follow-up for the THP and HP groups (p = .001 and .004 respectively). Using the same procedure for counter conditioning showed the THP group had a significant increase between baseline, post-intervention (p = .000) and follow-up (p = .04). However, there was a significant decrease in counter conditioning between post-intervention and follow-up (p = .001). Main effects tests for time showed that the two intervention groups had significantly increased their mean PA between baseline and post-intervention (p = .000) and also from baseline to follow-up (p = .000).Main effects for time showed that the THP group had a significant increase for stimulus control between baseline and post-intervention  from the TTM in conjunction within the HPM would result in greater increases in PA related cognitions and PA behavior. This integration of models was hypothesized to address the lack of consideration of environmental influences within the HPM and acknowledges the substantial body of research showing that TTM tailored interventions can promote an individual's progression through stages -37. All As already mentioned, participants in the THP group also reported more PA at post intervention than the HP group, although these differences were not statistically significant. At the end of intervention period both the THP and HP groups reported spending about one hour more in activity per day compared to participants in the control group who increased their activity by only six minutes per day compared to baseline. This finding is likely related to the overall advancement into action stages by participants in both intervention groups because a number of other researchers have found that participants in the action stages reported more PA than those are in the pre-action stages -37. WhilSubstantial relapses in behavior are generally observed in many intervention studies \"when the intensive intervention ends and external supports are withdrawn\" . TherefoA unique aspect of this research was the involvement of the participants' teachers and mothers with the intention of changing cultural norms and providing vicarious learning for the participants through observing important others engaged in PA. As noted in the introduction, the cultural norms for Iranian females to be active are restrictive. Therefore, it may be that by asking the participants' teachers and mothers to encourage the participants to be more active and to express their expectations that the girls be more active, a shift occurred around social norms for the participants within this study. However, it also may be that changes occurred due to peer learning and further research is required to clarify this finding. In general however, this is an extremely encouraging finding that can be used when creating interventions with similar populations.Another important strength of the current study was the duration of the intervention (24 weeks) and the inclusion of follow-up assessments. To achieve significant changes in deeply entrenched behaviors, interventions among adolescents should last longer than one semester . While pThere were several limitations of the present study. First, the data were measured by self-report questionnaire which introduces the possibility of biased results. Another limitation is the assessment of the validity of the CAAL and it is recommended that the CAAL be further validated with an objective measure in Iranian adolescents. It should be noted however, that test-retest reliability of the CAAL in this study was .98. Another limitation is the restriction of these interventions to participants in the preparation stage at baseline. Future research should expand these interventions to include participants at other stages of change at baseline. Such research would also necessitate expanding to other processes of change such as consciousness raising for participants in precontemplation.Outcome evaluation showed a positive short-term effect for the intervention groups on stage of readiness, potential determinants of PA and on amount of PA, as both intervention groups increased their PA by approximately one hour per day. Although participants in the THP group reported using more behavioral processes than those in the HP group, no significant differences were found between the THP and HP groups for PA at the post intervention. However, the THP group recorded more PA and more positive results on most of the potential determinants compared to the control group and therefore appears to be the stronger intervention. At the six month follow-up, PA levels had decreased from posttest and fewer students in both intervention groups were in the action stages of behavior change. However, the significant differences between the HP and control groups for PA were not present at the six-month follow-up, but some differences between the THP and control groups were still present indicating that this was the stronger intervention.Iranian girls face many barriers to an active lifestyle, including lack of suitable places to be active, access to facilities and resources, cultural limitations, and the low importance placed on exercising over other activities such as doing homework or home responsibilities. Therefore, access to equipment and facilities and a supportive environment are important strategies for promoting PA among this group of adolescents . Indeed,The author(s) declare that they have no competing interests.PT participated in the design of the study, performed the statistical analysis and drafted the manuscript. TB participated in the statistical analysis, helped to draft the manuscript, and read the paper critically for theoretical content and interpretation of study findings. DL participated in the sequence alignment and helped to draft the manuscript. SN and FG conceived of the study and participated in its design and coordination. All authors read and approved the final manuscript."]}
{"representative": "The prevalence of overweight and obesity (OW/OB) among adolescents worldwide has increased since the 60 s. Spain has reached one of the highest OW/OB prevalence rates among adolescents from European countries. The aim of this methodological paper is to describe the design and evaluation in the EVASYON study .st to 9th visits), and extensive during the last 11 months (10th to 20th visits). In order to assess the efficacy of the treatment, 8 dimensions were measured: diet; physical activity and fitness; eating behaviour; body composition; haematological profile; metabolic profile; minerals and vitamins; immuno-inflammatory markers. Moreover, genetic polymorphisms were also determined.The EVASYON was planned by a multidisciplinary team to treat OW/OB in Spanish adolescents. The EVASYON is a multi-centre study conducted in 5 hospitals in 5 Spanish cities  and two hundred and four OW/OB Spanish adolescents were recruited for this intervention. The treatment was implemented for approximately one-year follow-up. The adolescents were treated in groups of a maximum of 10 subjects; each group had 20 visits during the treatment period in two phases: intensive during the first 2 months (1The treatment programme developed in the EVASYON study was designed as a national pilot study to be implemented as an effective treatment for adolescents with OW/OB into the Spanish Health Care Service. Adolescence is characterized by important changes in body size and composition. Obesity started to appear as a public health problem in the last decades of the 20th century ; currentOverweight prevalence among adolescents around the world has increased since the 1960s. Approximately 14-15% of all 15-yr-old youngsters in the United States may be classified as obese . OverweiIt is widely accepted that treating childhood overweight is an important contribution to the multilevel response to the obesity epidemic . EffectiThe main aims of the EVASYON study  were: 1) to develop a treatment programme including education on nutrition and physical activity, 2) to implement this programme for one year in Spanish adolescents with overweight and obesity and 3) to evaluate its efficacy.For comparative and popularization purposes with previous and future studies, the aim of this paper was to describe the design and evaluation methods during the EVASYON study.The design of the EVASYON Study is an interventional study in a cohort of overweight and obese adolescents aged 13 to 16 years. Despite the lack of control group, we aim to assess the determinants of the treatment effectiveness.In order to estimate the sample size, we considered the results obtained in the AVENA study, a multicenter evaluation of the nutritional status of Spanish adolescents , showed Before starting the EVASYON programme, a screening was performed of all candidates. Several inclusion criteria were defined to homogenize sample characteristics. Inclusion criteria in the EVASYON programme are shown in Table Nine measurement categories were assessed: 1) Diet; 2) Physical activity and health-related physical fitness; 3) Psychological profile; 4) Body composition; 5) Haematological profile; 6) Biochemistry and metabolic profiles; 7) Mineral and vitamin profile; 8) Immunological profile; 9) Genetic profile.All the parameters of each measurement category, excluding genetic profile were assessed at least at four points Figure : baselinA trained dietician conducted face-to-face interviews with participants and their parents  at the beginning of the programme and visits 1, 9, and 20 . Nutrient intake scores were computed with and om Spain ,31.Physical activity was assessed applying a combination of methods. Participants in the EVASYON study wore the ActiGraph GT1M activity monitor . The ActiGraph GT1M is a small and lightweight uniaxial accelerometer  validated widely in laboratory and free-living conditions with children and adolescents . AccordiIn the EVASYON study, health-related physical fitness was assessed using the validated and standardized tests included in the EUROFIT  and FITN2max may be estimated with the Leger equation.The progressive 20-m shuttle-run test published by Leger and Lambert in 1982 and revised in 1988  is one o\u00a9; Takei, Tokyo, Japan). Dynamometer was adjusted by sex and hand size for each subject [Subjects perform the test in a standard bipedal position and with the arm in complete extension without touching any part of the body with the hand-dynamometer  as fast as possible.Proposed in the FITNESSGRAM battery, this test measures the flexibility of the hamstring muscles. The test is performed with a standard and sturdy box with a scale on the top of the box. Back-saver sit and reach is similar to the traditional sit and reach except that the measurement is performed on one side at a time, so each side has its individual score.The questionnaires used during the EVASYON Study were the following:In order to assess self-esteem, the AF-5  multidimThe ABOS scale was developed to evaluate patient's symptoms based on the relatives' description of the subject's eating behaviour. This test is useful in a clinical setting for evaluation of patients with eating disorders. The original version  evaluateEDI-2 is a self-report instrument that assesses the cognitive and behavioural characteristics commonly found in individuals with eating disorders . It is oThe anthropometry protocol used in the EVASYON study was identical to the standardized protocol used in the AVENA study with more than 2000 Spanish adolescents .2). Skinfold thickness were measured on the left side of the body [Each measurement was taken three times but not consecutively. A complete set of measurements was performed and then repeated twice more. Weight and height are obtained by standardized procedures. Body mass index is calculated as weigh/height squared  the subject contracts muscle biceps as much as possible, and the tape is passed around the arm so that it touches the skin surrounding the maximum circumference. To measure the waist circumference, the tape is applied horizontally midway between the lowest rib margin and the iliac crest, at the end of gentle expiration. The hip circumference measurement is taken at the point yielding the maximum circumference over the buttocks, with the tape held in a horizontal plane. Proximal thigh circumference is measured just below the gluteal fold and perpendicular to its long axis; the subject stands erect with the feet slightly apart and the body mass evenly distributed between both legs. In addition to the anthropometry measurements, in Zaragoza and Granada, we used laboratory techniques. Participants in these cities (n\u224880) were assessed by bioelectrical impedance (BIA), and dual energy X-ray absortiometry (DXA). BOD PODPubertal development was assessed according to the five established Tanner stages . Each stBlood pressure was measured using a validated digital automatic blood pressure monitor  according to the International Protocol of the European Society of Hypertension .Blood collection was performed upon an empty stomach between 8 and 10 AM, after fasting for 10 h. Health state of human volunteers was optimal for blood sample collection.In all cases, blood was extracted from the antecubital vein 21.5 mL). Blood collection was carried out by experienced clinical staff. Blood samples were divided into aliquots as follows: 1.5 mL in EDTA tube , 10 mL in EDTA tube (for plasma extraction) and 10 mL in gel containing tube (for serum extraction). To avoid erroneous values due to sample deterioration, blood cell counts and differentials were analyzed in the laboratories of each hospital that participated in this study. Within 1-h of collection, blood was centrifuged and aliquots of plasma or serum were stored at -80\u00b0C. Serum samples were sent to each laboratory at convenient time intervals . Haematological, lipidic-metabolic, vitamins, immunological and genetic studies were centralized in each participating laboratory. The parameters included in each of these categories are presented in Tables 1.5 mL. B\u00ae, Bio Rad Diagnostics Group, Irvine, CA, USA) was used to assess precision. Na+, Cl- and K+ were measured with an electrolyte analyser . Urine samples were diluted 2:1 (urine: diluent) with diluent for urine S2490 . QualitycheckTM S2480 and S2470 were used as internal standards  to assess precision. Urine total volume and pH were also monitored.48 h urine samples were collected coinciding with the two last days of 72 h dietary records. Subjects were given detailed verbal and written instructions about how to collect a complete 48 h urine sample and given 3 L sterile plastic bottles. Collection began with the second urine of the second day and ended with the first urine of the last day of 72 h dietary record. Urine creatinine concentration was determined by kinetic Jaffe reaction on a Cobas centrifugal analyser . Urinary Ca was determined by atomic absorption spectrometry . Phosphorous was analysed by photocolorimetry . Quantitative urine control  and the EEC Good Clinical Practice recommendations , and current Spanish legislation regulating clinical research in humans . The study was approved by the Ethics Committee of each hospital that participated in this project and by the Ethics Committee of the Spanish Council for Scientific Research (CSIC). The study was explained to the participants before starting, and the volunteers, parents or tutors signed an informed consent.Access to the database was restricted to the researchers that participated in this study. Therefore, the information obtained in the study was considered as confidential, although the sanitary authorities have full access rights for inspection purposes.The studied parameters are treated considering some fixed variability factors: gender, age, tanner, BMI classification . AttendaFirstly, an assessment of missing data and the identification of potential outliers are carried out. The statistic processes is as follows:1) Univariate descriptive analysis, study of data distribution, basic statistics such as central and dispersion values. The interrelationship among variables is assessed by studying the correlation coefficients on the basis of their distribution and their association to those groups defined upon random and fixed factors. Pair comparison tests with previous analysis of the homogeneity of variance are used. Chi-Squared tests and exact probability calculations are also performed to study the relationship among qualitative variables.2) General lineal models for each point in time and as a function of time . Multivariate models are used from different perspectives: classical regression models and continuous or categorical principal component analysis are used to describe multivariate interrelationship among selected variables. Also, multivariate analyses are used to predict the intervention success at a selected period of time and at the end of the study by variables that measure the health improvement of the patients.The analysis of the data will be done using the statistical packages SPSS and SAS.The EVASYON study develops, for the first time in Spain, a multidisciplinary treatment programme for adolescents with overweight and obesity that is aimed at all possibly involved areas of the individual, such as dietary habits, physical activity and cognitive and psychological profiles, in order to prevent the development, in an immediate future and in the long term, of chronic diseases associated with obesity such as diabetes, hypertension, cardiovascular diseases, metabolic syndrome, etc. Health-related researchers who participate in this study expect that the programme, once its efficacy has been proved, may be applicable in any hospital or clinic from the Spanish System of Health with a multidisciplinary group consisting of paediatricians, endocrinologists, psychiatrists, psychologists, physical activity specialists and dieticians.The EVASYON study is essentially characterized for being a multidisciplinary and multicentre project. Thus, both the assessment of the efficacy and the protocols of the treatment have been developed by professionals in each of the specific fields: psychology, nutrition, physical activity, fitness, paediatrics, body composition, genetics, immunology and biochemistry. Moreover, the study has been conducted in 5 hospitals from 5 Spanish cities, respectively . Adaptation of the protocol for 5 different hospitals had as principal advantage that the treatment programme potentially will be easier to implement in any healthcare centre of the Spanish Health Care Service.Nonetheless, organizing a single educational treatment for all the centres and the assessment protocols was a complex process. Training workshops for all the EVASYON members, who were going to take part in the programme and in the assessment, were conducted to unify criteria and to test the methodologies presented in this article before beginning the study. One pilot group in each hospital served to solve starting-up problems in the treatment programme, doubts, human and technical resources and coordination with adolescents and their families. Some decisions were also made in the workshops on how to send blood samples, protocols of physical fitness test to carry out in hospitals, possible postbariatric surgery or follow-up of participants after the study ended.The EVASYON study has both strengths and weaknesses. Several strengths that the EVASYON study presents are as follows: 1) the sample size achieved of 204 adolescents with overweight and obesity provides an acceptable statistical power to conduct multivariable analysis . Few studies performed in clinical settings have recruited, to our knowledge, a greater number of participants than the EVASYON study -26 the dThe EVASYON study also involves weaknesses that must be taken into account: 1) the study does not include a control group of overweight or obese adolescents. This makes it difficult to understand the progress, maintenance or deterioration of the baseline health of participants. Strong weight loss studies with educational therapeutic programme based on physical activity and nutrition have included control groups  or not ; 2) an iInitiatives as the EVASYON study contribute to the development of the Spanish Strategy for Nutrition, Physical Activity and the Prevention of Obesity (NAOS Strategy) initiated in 2005 by the Ministry of Health and Consumer Affairs . The NAOIn summary, the EVASYON study is an interventional study assessing the effectiveness of an educational therapeutic model in physical activity and nutrition in Spanish adolescents with overweight and obesity. The EVASYON programme attempts to be a national pilot study that may be implemented as a method of treatment of obesity in adolescents into the Spanish Health Care Service. This multidisciplinary and multicenter study assesses changes in participants for approximately 1-year follow-up over 8 dimensions: 1) diet, 2) physical activity and health-related physical fitness, 3) psychology, 4) body composition, 5) haematology, 6) biochemical and metabolic profiles, 7) mineral and vitamin profiles, and 8) immunology profile. Genetic profile was also assessed for examining the influence of gene-environmental interactions on obesity.The authors declare that they have no competing interests.DMG, SGM, and MAP contributed equally to this work. AM, CRF, CC, AM, JMG designed the study and obtained funding. DMG, SGM, MAP, EN, JW, OLV, CA, MPV, MD, JAM, MGF and LAM provided insight into the study design. All authors participated in the writing of the paper and provided comments on the drafts and approved the final version.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2458/9/414/prepub", "texts": ["The prevalence of overweight and obesity (OW/OB) among adolescents worldwide has increased since the 60 s. Spain has reached one of the highest OW/OB prevalence rates among adolescents from European countries. The aim of this methodological paper is to describe the design and evaluation in the EVASYON study .st to 9th visits), and extensive during the last 11 months (10th to 20th visits). In order to assess the efficacy of the treatment, 8 dimensions were measured: diet; physical activity and fitness; eating behaviour; body composition; haematological profile; metabolic profile; minerals and vitamins; immuno-inflammatory markers. Moreover, genetic polymorphisms were also determined.The EVASYON was planned by a multidisciplinary team to treat OW/OB in Spanish adolescents. The EVASYON is a multi-centre study conducted in 5 hospitals in 5 Spanish cities  and two hundred and four OW/OB Spanish adolescents were recruited for this intervention. The treatment was implemented for approximately one-year follow-up. The adolescents were treated in groups of a maximum of 10 subjects; each group had 20 visits during the treatment period in two phases: intensive during the first 2 months (1The treatment programme developed in the EVASYON study was designed as a national pilot study to be implemented as an effective treatment for adolescents with OW/OB into the Spanish Health Care Service. Adolescence is characterized by important changes in body size and composition. Obesity started to appear as a public health problem in the last decades of the 20th century ; currentOverweight prevalence among adolescents around the world has increased since the 1960s. Approximately 14-15% of all 15-yr-old youngsters in the United States may be classified as obese . OverweiIt is widely accepted that treating childhood overweight is an important contribution to the multilevel response to the obesity epidemic . EffectiThe main aims of the EVASYON study  were: 1) to develop a treatment programme including education on nutrition and physical activity, 2) to implement this programme for one year in Spanish adolescents with overweight and obesity and 3) to evaluate its efficacy.For comparative and popularization purposes with previous and future studies, the aim of this paper was to describe the design and evaluation methods during the EVASYON study.The design of the EVASYON Study is an interventional study in a cohort of overweight and obese adolescents aged 13 to 16 years. Despite the lack of control group, we aim to assess the determinants of the treatment effectiveness.In order to estimate the sample size, we considered the results obtained in the AVENA study, a multicenter evaluation of the nutritional status of Spanish adolescents , showed Before starting the EVASYON programme, a screening was performed of all candidates. Several inclusion criteria were defined to homogenize sample characteristics. Inclusion criteria in the EVASYON programme are shown in Table Nine measurement categories were assessed: 1) Diet; 2) Physical activity and health-related physical fitness; 3) Psychological profile; 4) Body composition; 5) Haematological profile; 6) Biochemistry and metabolic profiles; 7) Mineral and vitamin profile; 8) Immunological profile; 9) Genetic profile.All the parameters of each measurement category, excluding genetic profile were assessed at least at four points Figure : baselinA trained dietician conducted face-to-face interviews with participants and their parents  at the beginning of the programme and visits 1, 9, and 20 . Nutrient intake scores were computed with and om Spain ,31.Physical activity was assessed applying a combination of methods. Participants in the EVASYON study wore the ActiGraph GT1M activity monitor . The ActiGraph GT1M is a small and lightweight uniaxial accelerometer  validated widely in laboratory and free-living conditions with children and adolescents . AccordiIn the EVASYON study, health-related physical fitness was assessed using the validated and standardized tests included in the EUROFIT  and FITN2max may be estimated with the Leger equation.The progressive 20-m shuttle-run test published by Leger and Lambert in 1982 and revised in 1988  is one o\u00a9; Takei, Tokyo, Japan). Dynamometer was adjusted by sex and hand size for each subject [Subjects perform the test in a standard bipedal position and with the arm in complete extension without touching any part of the body with the hand-dynamometer  as fast as possible.Proposed in the FITNESSGRAM battery, this test measures the flexibility of the hamstring muscles. The test is performed with a standard and sturdy box with a scale on the top of the box. Back-saver sit and reach is similar to the traditional sit and reach except that the measurement is performed on one side at a time, so each side has its individual score.The questionnaires used during the EVASYON Study were the following:In order to assess self-esteem, the AF-5  multidimThe ABOS scale was developed to evaluate patient's symptoms based on the relatives' description of the subject's eating behaviour. This test is useful in a clinical setting for evaluation of patients with eating disorders. The original version  evaluateEDI-2 is a self-report instrument that assesses the cognitive and behavioural characteristics commonly found in individuals with eating disorders . It is oThe anthropometry protocol used in the EVASYON study was identical to the standardized protocol used in the AVENA study with more than 2000 Spanish adolescents .2). Skinfold thickness were measured on the left side of the body [Each measurement was taken three times but not consecutively. A complete set of measurements was performed and then repeated twice more. Weight and height are obtained by standardized procedures. Body mass index is calculated as weigh/height squared  the subject contracts muscle biceps as much as possible, and the tape is passed around the arm so that it touches the skin surrounding the maximum circumference. To measure the waist circumference, the tape is applied horizontally midway between the lowest rib margin and the iliac crest, at the end of gentle expiration. The hip circumference measurement is taken at the point yielding the maximum circumference over the buttocks, with the tape held in a horizontal plane. Proximal thigh circumference is measured just below the gluteal fold and perpendicular to its long axis; the subject stands erect with the feet slightly apart and the body mass evenly distributed between both legs. In addition to the anthropometry measurements, in Zaragoza and Granada, we used laboratory techniques. Participants in these cities (n\u224880) were assessed by bioelectrical impedance (BIA), and dual energy X-ray absortiometry (DXA). BOD PODPubertal development was assessed according to the five established Tanner stages . Each stBlood pressure was measured using a validated digital automatic blood pressure monitor  according to the International Protocol of the European Society of Hypertension .Blood collection was performed upon an empty stomach between 8 and 10 AM, after fasting for 10 h. Health state of human volunteers was optimal for blood sample collection.In all cases, blood was extracted from the antecubital vein 21.5 mL). Blood collection was carried out by experienced clinical staff. Blood samples were divided into aliquots as follows: 1.5 mL in EDTA tube , 10 mL in EDTA tube (for plasma extraction) and 10 mL in gel containing tube (for serum extraction). To avoid erroneous values due to sample deterioration, blood cell counts and differentials were analyzed in the laboratories of each hospital that participated in this study. Within 1-h of collection, blood was centrifuged and aliquots of plasma or serum were stored at -80\u00b0C. Serum samples were sent to each laboratory at convenient time intervals . Haematological, lipidic-metabolic, vitamins, immunological and genetic studies were centralized in each participating laboratory. The parameters included in each of these categories are presented in Tables 1.5 mL. B\u00ae, Bio Rad Diagnostics Group, Irvine, CA, USA) was used to assess precision. Na+, Cl- and K+ were measured with an electrolyte analyser . Urine samples were diluted 2:1 (urine: diluent) with diluent for urine S2490 . QualitycheckTM S2480 and S2470 were used as internal standards  to assess precision. Urine total volume and pH were also monitored.48 h urine samples were collected coinciding with the two last days of 72 h dietary records. Subjects were given detailed verbal and written instructions about how to collect a complete 48 h urine sample and given 3 L sterile plastic bottles. Collection began with the second urine of the second day and ended with the first urine of the last day of 72 h dietary record. Urine creatinine concentration was determined by kinetic Jaffe reaction on a Cobas centrifugal analyser . Urinary Ca was determined by atomic absorption spectrometry . Phosphorous was analysed by photocolorimetry . Quantitative urine control  and the EEC Good Clinical Practice recommendations , and current Spanish legislation regulating clinical research in humans . The study was approved by the Ethics Committee of each hospital that participated in this project and by the Ethics Committee of the Spanish Council for Scientific Research (CSIC). The study was explained to the participants before starting, and the volunteers, parents or tutors signed an informed consent.Access to the database was restricted to the researchers that participated in this study. Therefore, the information obtained in the study was considered as confidential, although the sanitary authorities have full access rights for inspection purposes.The studied parameters are treated considering some fixed variability factors: gender, age, tanner, BMI classification . AttendaFirstly, an assessment of missing data and the identification of potential outliers are carried out. The statistic processes is as follows:1) Univariate descriptive analysis, study of data distribution, basic statistics such as central and dispersion values. The interrelationship among variables is assessed by studying the correlation coefficients on the basis of their distribution and their association to those groups defined upon random and fixed factors. Pair comparison tests with previous analysis of the homogeneity of variance are used. Chi-Squared tests and exact probability calculations are also performed to study the relationship among qualitative variables.2) General lineal models for each point in time and as a function of time . Multivariate models are used from different perspectives: classical regression models and continuous or categorical principal component analysis are used to describe multivariate interrelationship among selected variables. Also, multivariate analyses are used to predict the intervention success at a selected period of time and at the end of the study by variables that measure the health improvement of the patients.The analysis of the data will be done using the statistical packages SPSS and SAS.The EVASYON study develops, for the first time in Spain, a multidisciplinary treatment programme for adolescents with overweight and obesity that is aimed at all possibly involved areas of the individual, such as dietary habits, physical activity and cognitive and psychological profiles, in order to prevent the development, in an immediate future and in the long term, of chronic diseases associated with obesity such as diabetes, hypertension, cardiovascular diseases, metabolic syndrome, etc. Health-related researchers who participate in this study expect that the programme, once its efficacy has been proved, may be applicable in any hospital or clinic from the Spanish System of Health with a multidisciplinary group consisting of paediatricians, endocrinologists, psychiatrists, psychologists, physical activity specialists and dieticians.The EVASYON study is essentially characterized for being a multidisciplinary and multicentre project. Thus, both the assessment of the efficacy and the protocols of the treatment have been developed by professionals in each of the specific fields: psychology, nutrition, physical activity, fitness, paediatrics, body composition, genetics, immunology and biochemistry. Moreover, the study has been conducted in 5 hospitals from 5 Spanish cities, respectively . Adaptation of the protocol for 5 different hospitals had as principal advantage that the treatment programme potentially will be easier to implement in any healthcare centre of the Spanish Health Care Service.Nonetheless, organizing a single educational treatment for all the centres and the assessment protocols was a complex process. Training workshops for all the EVASYON members, who were going to take part in the programme and in the assessment, were conducted to unify criteria and to test the methodologies presented in this article before beginning the study. One pilot group in each hospital served to solve starting-up problems in the treatment programme, doubts, human and technical resources and coordination with adolescents and their families. Some decisions were also made in the workshops on how to send blood samples, protocols of physical fitness test to carry out in hospitals, possible postbariatric surgery or follow-up of participants after the study ended.The EVASYON study has both strengths and weaknesses. Several strengths that the EVASYON study presents are as follows: 1) the sample size achieved of 204 adolescents with overweight and obesity provides an acceptable statistical power to conduct multivariable analysis . Few studies performed in clinical settings have recruited, to our knowledge, a greater number of participants than the EVASYON study -26 the dThe EVASYON study also involves weaknesses that must be taken into account: 1) the study does not include a control group of overweight or obese adolescents. This makes it difficult to understand the progress, maintenance or deterioration of the baseline health of participants. Strong weight loss studies with educational therapeutic programme based on physical activity and nutrition have included control groups  or not ; 2) an iInitiatives as the EVASYON study contribute to the development of the Spanish Strategy for Nutrition, Physical Activity and the Prevention of Obesity (NAOS Strategy) initiated in 2005 by the Ministry of Health and Consumer Affairs . The NAOIn summary, the EVASYON study is an interventional study assessing the effectiveness of an educational therapeutic model in physical activity and nutrition in Spanish adolescents with overweight and obesity. The EVASYON programme attempts to be a national pilot study that may be implemented as a method of treatment of obesity in adolescents into the Spanish Health Care Service. This multidisciplinary and multicenter study assesses changes in participants for approximately 1-year follow-up over 8 dimensions: 1) diet, 2) physical activity and health-related physical fitness, 3) psychology, 4) body composition, 5) haematology, 6) biochemical and metabolic profiles, 7) mineral and vitamin profiles, and 8) immunology profile. Genetic profile was also assessed for examining the influence of gene-environmental interactions on obesity.The authors declare that they have no competing interests.DMG, SGM, and MAP contributed equally to this work. AM, CRF, CC, AM, JMG designed the study and obtained funding. DMG, SGM, MAP, EN, JW, OLV, CA, MPV, MD, JAM, MGF and LAM provided insight into the study design. All authors participated in the writing of the paper and provided comments on the drafts and approved the final version.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2458/9/414/prepub"]}
{"representative": "Maintaining a healthy weight and undertaking regular physical activity are important for the secondary prevention of cardiovascular disease (CVD). However, many people with CVD are overweight and insufficiently active. In addition, in Australia only 20-30% of people requiring cardiac rehabilitation (CR) for CVD actually attend. To improve outcomes of and access to CR the efficacy, effectiveness and cost-effectiveness of alternative approaches to CR need to be established.This research will determine the efficacy of a telephone-delivered lifestyle intervention, promoting healthy weight and physical activity, in people with CVD in urban and rural settings. The control group will also act as a replication study of a previously proven physical activity intervention, to establish whether those findings can be repeated in different urban and rural locations. The cost-effectiveness and acceptability of the intervention to CR staff and participants will also be determined.This study is a randomised controlled trial. People referred for CR at two urban and two rural Australian hospitals will be invited to participate. The intervention  group will participate in four telephone delivered behavioural coaching and goal setting sessions over eight weeks. The coaching sessions will be on weight, nutrition and physical activity and will be supported by written materials, a pedometer and two follow-up booster telephone calls. The control  group will participate in a six week intervention previously shown to increase physical activity, consisting of two telephone delivered behavioural coaching and goal setting sessions on physical activity, supported by written materials, a pedometer and two booster phone calls. Data will be collected at baseline, eight weeks and eight months for the intervention group . The primary outcome is weight change. Secondary outcomes include physical activity, sedentary time and nutrition habits. Costs will be compared with outcomes to determine the relative cost-effectiveness of the healthy weight and physical activity interventions.This study addresses a significant gap in public health practice by providing evidence for the efficacy and cost-effectiveness of a low cost, low contact, high reach intervention promoting healthy weight and physical activity among people with CVD in rural and urban areas in Australia. The replication arm of the study, undertaken by the control group, will demonstrate whether the findings of the previously proven physical activity intervention can be generalised to new settings. This population-based approach could potentially improve access to and outcomes of secondary prevention programs, particularly for rural or disadvantaged communities.ACTRN12610000102077 Cardiovascular disease (CVD) is the leading cause of death in Australia  and contThus the challenge is to improve health outcomes for the majority of people with CVD who do not attend CR. In response to this challenge, investigating alternative service models for delivering CR programs shows promise . To deteDistance interventions, delivered remotely via print, telephone or internet, are likely to have improved population reach, accessibility, cost-effectiveness and maintenance of gains at follow-up compared to centre-based programs . SystemaReports of interventions promoting healthy weight and physical activity in people with CVD are scarce. A recent Australian study identified significant benefits of a telephone-delivered, pedometer-based intervention on physical activity levels among people with cardiac disease who attended outpatient CR . AnotherEven fewer interventions address the majority of cardiac patients who do not attend CR. The CHOICE program included a face-to-face consultation and four follow-up phone calls and was effective in improving cardiac risk factors for people with cardiac disease who had not attended CR . Furber Cost effectiveness analyses are rarely conducted on health care interventions  and to oThe PANACHE  randomised control trial will investigate if a home-based approach  can decrease obesity and increase physical inactivity in people with CVD in urban and rural areas in Australia. It will also determine whether the outcomes of an intervention previously found to increase physical activity ,27 are rThis study is a randomised controlled trial comparing the efficacy of a healthy weight telephone coaching intervention (intervention group) with a physical activity telephone coaching intervention (control group). An outline is shown in Figure Approval to conduct this research has been granted by the Human Research Ethics Committees from University of Wollongong, South Eastern Sydney and Illawarra Area Health Service, Greater Southern Area Health Service and the University of New South Wales. All people referred to outpatient CR over a 12-18 month period at two Sydney and two NSW rural hospitals in Australia will be invited to participate in the study, whether or not they attend outpatient CR. Based on a previous Australian study , it is aParticipants will be recruited six-eight weeks after referral to CR by which time they would be likely to be clinically stable in their recovery process. Brief written information about the study will be included in the information packs distributed to people referred to CR. A personalised invitation letter will also be mailed, followed up with a telephone call.During the follow up telephone call participants will be randomised by the researcher into intervention and control groups when they agree to be enrolled in the study. Participants will be block randomized within site. Microsoft Excel will be used to generate random numbers and the Statistical Analysis System (SAS) will be used to randomise these numbers into sets of two letters  by blocks of four to ensure a balanced sample size across both study groups . The ranThe intervention  group will receive an eight week healthy weight intervention based on social cognitive theory ,34 which2 participants will be recommended to lose weight [2 the focus will be on weight maintenance [Goals will be individualized and if the participant's BMI is greater than 24.9 kg/me weight  and to untenance  and 30 mThe healthy weight intervention was piloted with nine rural participants. The findings were used to refine evaluation questions and procedures, modify the telephone coaching guide and improve the suitability of written support materials.The control  group will receive the same six week physical activity intervention previously found to be efficacious ,27. AlsoQuestionnaires will be completed by telephone at baseline, eight weeks and eight months for the intervention group and at baseline, six weeks and six months for the control group. Researchers administering the questionnaires will be trained to follow written standard procedures. They will be supervised during the administration of the initial questionnaires and thereafter at random intervals. All objective measures will be obtained by the same researcher following a written standard protocol.Semi-structured interviews will be conducted with urban and rural CR staff to assess their views of the usefulness and acceptability of the program and its implementation in their setting. Focus groups will be held with rural and urban study participants regarding their experiences of the program and its delivery. Participants will also provide information on process measures when they complete the telephone questionnaires at week eight (intervention) and week six (control) on the acceptability of program activities and materials such as resources on weight control, nutritional and physical activity, and coaching advice. The weight, nutrition and physical activity goals set by participants during their telephone coaching sessions will also be recorded.The primary outcome is self-reported weight and BMI . SecondaTo validate self-reported changes in height, weight, food intake and physical activity, objective data will be collected at baseline and at eight months from a sub-group of 25% of the intervention group (a convenience sample of 45 participants). At baseline and at eight months the researcher will meet with this sub-group to measure their height, weight and waist circumference after they have self-reported these measures in the questionnaires administered via telephone at baseline and eight months. Participants will then be asked to record their intake of food and drink for three days (two weekdays and one weekend day) and to wear an MTI Actigraph accelerometer to record their physical activity for the next seven days. At the end of the week in which the accelerometer is worn the self-report questions on physical activity, sedentary activity and nutrition habits, which ask about these activities over the last seven days, will be completed. Thus the objective data obtained using a food diary and accelerometer will be collected over the same time period as the self-reported data. A three-day food diary collected over two week days and one weekend day has been found to be a reliable measure of usual energy intake . AccelerCosts calculated will include program costs , direct health care costs related to participants' cardiac conditions  and other costs (for example participant's expenditure on exercise related products and services such as shoes and exercise classes). Information will be collected regarding the number of days absent from work or normal activities due to cardiac problems.2 BMI between the intervention and control group (based on the COACH study effects on weight loss [To detect a reduction of 1.3 kg in weight and 0.5 kg/mght loss ) with a The analyses of the trial will be based on (i) intention to treat and (ii) treatment received. Bivariate and multivariate analyses will assess the effects of the intervention (compared to controls) on weight loss, sedentary behaviour, nutrition and physical activity adjusted for residence , age and sex for all cases and then treatment received after initial intention to treat analysis. Continuous data will be analysed with paired t-tests and linear regression and categorical variables with chi square tests and logistic regression with p < 0.05 as the level of significance but adjusted appropriately when multiple testing is conducted. Analyses will be performed with PASW 18.0 . Food diaries will be analysed using FoodWorks 2007 (Xyris Software).The economic evaluation will be conducted using accepted guidelines . To deteThematic analysis will be used to examine transcripts of the interviews with CR staff and the focus groups with study participants. Two researchers will independently code the themes arising and then compare and discuss their coding. For the purpose of triangulation, these researchers will then discuss the themes with an additional researcher. The steps taken in the thematic analysis and the reasons for taking them will be documented to provide an audit trail.Despite the effectiveness of conventional centre-based CR programs, participation rates are low and the majority of people requiring CR are missing out on evidence-based health benefits of lifestyle interventions for cardiac patients. In addition, little research has been conducted on improving health outcomes for the majority of cardiac patients who do not attend CR. This study addresses these gaps in public health practice, firstly by testing an alternative delivery mode for CR, secondly by targeting the entire population of people referred for CR, irrespective of whether they attend a CR program or not, and thirdly by establishing the efficacy of a healthy weight intervention for people with cardiac disease. The economic impact of secondary prevention programs for CVD is an under-researched area. The economic analysis conducted alongside this study will provide important information on the relative costs and benefits of the intervention.This study will show whether the population-based, low contact, high reach intervention tested can promote healthy weight and physical activity among people with CVD in rural and urban settings and whether it can be delivered cost effectively. By replicating the previously proven physical activity only program ,27 in thThe findings of this study will have significant implications for the management of people with CVD. In addition to improving health outcomes for people with cardiac disease, these interventions have the potential to reduce costs and improve access to CR services, particularly for disadvantaged and rural people. They could be a feasible addition to existing services and could also be delivered to people with CVD who have already attended CR programs as a \"maintenance\" program.The authors declare that they have no competing interests.JS drafted the manuscript, contributed to the study design and is coordinating the study. SF, MA-F, MH, PP, AM and AB contributed to the study design, advised on coordination of the study and reviewed the manuscript. All authors read and agreed to the manuscript as written.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2261/10/17/prepub", "texts": ["Maintaining a healthy weight and undertaking regular physical activity are important for the secondary prevention of cardiovascular disease (CVD). However, many people with CVD are overweight and insufficiently active. In addition, in Australia only 20-30% of people requiring cardiac rehabilitation (CR) for CVD actually attend. To improve outcomes of and access to CR the efficacy, effectiveness and cost-effectiveness of alternative approaches to CR need to be established.This research will determine the efficacy of a telephone-delivered lifestyle intervention, promoting healthy weight and physical activity, in people with CVD in urban and rural settings. The control group will also act as a replication study of a previously proven physical activity intervention, to establish whether those findings can be repeated in different urban and rural locations. The cost-effectiveness and acceptability of the intervention to CR staff and participants will also be determined.This study is a randomised controlled trial. People referred for CR at two urban and two rural Australian hospitals will be invited to participate. The intervention  group will participate in four telephone delivered behavioural coaching and goal setting sessions over eight weeks. The coaching sessions will be on weight, nutrition and physical activity and will be supported by written materials, a pedometer and two follow-up booster telephone calls. The control  group will participate in a six week intervention previously shown to increase physical activity, consisting of two telephone delivered behavioural coaching and goal setting sessions on physical activity, supported by written materials, a pedometer and two booster phone calls. Data will be collected at baseline, eight weeks and eight months for the intervention group . The primary outcome is weight change. Secondary outcomes include physical activity, sedentary time and nutrition habits. Costs will be compared with outcomes to determine the relative cost-effectiveness of the healthy weight and physical activity interventions.This study addresses a significant gap in public health practice by providing evidence for the efficacy and cost-effectiveness of a low cost, low contact, high reach intervention promoting healthy weight and physical activity among people with CVD in rural and urban areas in Australia. The replication arm of the study, undertaken by the control group, will demonstrate whether the findings of the previously proven physical activity intervention can be generalised to new settings. This population-based approach could potentially improve access to and outcomes of secondary prevention programs, particularly for rural or disadvantaged communities.ACTRN12610000102077 Cardiovascular disease (CVD) is the leading cause of death in Australia  and contThus the challenge is to improve health outcomes for the majority of people with CVD who do not attend CR. In response to this challenge, investigating alternative service models for delivering CR programs shows promise . To deteDistance interventions, delivered remotely via print, telephone or internet, are likely to have improved population reach, accessibility, cost-effectiveness and maintenance of gains at follow-up compared to centre-based programs . SystemaReports of interventions promoting healthy weight and physical activity in people with CVD are scarce. A recent Australian study identified significant benefits of a telephone-delivered, pedometer-based intervention on physical activity levels among people with cardiac disease who attended outpatient CR . AnotherEven fewer interventions address the majority of cardiac patients who do not attend CR. The CHOICE program included a face-to-face consultation and four follow-up phone calls and was effective in improving cardiac risk factors for people with cardiac disease who had not attended CR . Furber Cost effectiveness analyses are rarely conducted on health care interventions  and to oThe PANACHE  randomised control trial will investigate if a home-based approach  can decrease obesity and increase physical inactivity in people with CVD in urban and rural areas in Australia. It will also determine whether the outcomes of an intervention previously found to increase physical activity ,27 are rThis study is a randomised controlled trial comparing the efficacy of a healthy weight telephone coaching intervention (intervention group) with a physical activity telephone coaching intervention (control group). An outline is shown in Figure Approval to conduct this research has been granted by the Human Research Ethics Committees from University of Wollongong, South Eastern Sydney and Illawarra Area Health Service, Greater Southern Area Health Service and the University of New South Wales. All people referred to outpatient CR over a 12-18 month period at two Sydney and two NSW rural hospitals in Australia will be invited to participate in the study, whether or not they attend outpatient CR. Based on a previous Australian study , it is aParticipants will be recruited six-eight weeks after referral to CR by which time they would be likely to be clinically stable in their recovery process. Brief written information about the study will be included in the information packs distributed to people referred to CR. A personalised invitation letter will also be mailed, followed up with a telephone call.During the follow up telephone call participants will be randomised by the researcher into intervention and control groups when they agree to be enrolled in the study. Participants will be block randomized within site. Microsoft Excel will be used to generate random numbers and the Statistical Analysis System (SAS) will be used to randomise these numbers into sets of two letters  by blocks of four to ensure a balanced sample size across both study groups . The ranThe intervention  group will receive an eight week healthy weight intervention based on social cognitive theory ,34 which2 participants will be recommended to lose weight [2 the focus will be on weight maintenance [Goals will be individualized and if the participant's BMI is greater than 24.9 kg/me weight  and to untenance  and 30 mThe healthy weight intervention was piloted with nine rural participants. The findings were used to refine evaluation questions and procedures, modify the telephone coaching guide and improve the suitability of written support materials.The control  group will receive the same six week physical activity intervention previously found to be efficacious ,27. AlsoQuestionnaires will be completed by telephone at baseline, eight weeks and eight months for the intervention group and at baseline, six weeks and six months for the control group. Researchers administering the questionnaires will be trained to follow written standard procedures. They will be supervised during the administration of the initial questionnaires and thereafter at random intervals. All objective measures will be obtained by the same researcher following a written standard protocol.Semi-structured interviews will be conducted with urban and rural CR staff to assess their views of the usefulness and acceptability of the program and its implementation in their setting. Focus groups will be held with rural and urban study participants regarding their experiences of the program and its delivery. Participants will also provide information on process measures when they complete the telephone questionnaires at week eight (intervention) and week six (control) on the acceptability of program activities and materials such as resources on weight control, nutritional and physical activity, and coaching advice. The weight, nutrition and physical activity goals set by participants during their telephone coaching sessions will also be recorded.The primary outcome is self-reported weight and BMI . SecondaTo validate self-reported changes in height, weight, food intake and physical activity, objective data will be collected at baseline and at eight months from a sub-group of 25% of the intervention group (a convenience sample of 45 participants). At baseline and at eight months the researcher will meet with this sub-group to measure their height, weight and waist circumference after they have self-reported these measures in the questionnaires administered via telephone at baseline and eight months. Participants will then be asked to record their intake of food and drink for three days (two weekdays and one weekend day) and to wear an MTI Actigraph accelerometer to record their physical activity for the next seven days. At the end of the week in which the accelerometer is worn the self-report questions on physical activity, sedentary activity and nutrition habits, which ask about these activities over the last seven days, will be completed. Thus the objective data obtained using a food diary and accelerometer will be collected over the same time period as the self-reported data. A three-day food diary collected over two week days and one weekend day has been found to be a reliable measure of usual energy intake . AccelerCosts calculated will include program costs , direct health care costs related to participants' cardiac conditions  and other costs (for example participant's expenditure on exercise related products and services such as shoes and exercise classes). Information will be collected regarding the number of days absent from work or normal activities due to cardiac problems.2 BMI between the intervention and control group (based on the COACH study effects on weight loss [To detect a reduction of 1.3 kg in weight and 0.5 kg/mght loss ) with a The analyses of the trial will be based on (i) intention to treat and (ii) treatment received. Bivariate and multivariate analyses will assess the effects of the intervention (compared to controls) on weight loss, sedentary behaviour, nutrition and physical activity adjusted for residence , age and sex for all cases and then treatment received after initial intention to treat analysis. Continuous data will be analysed with paired t-tests and linear regression and categorical variables with chi square tests and logistic regression with p < 0.05 as the level of significance but adjusted appropriately when multiple testing is conducted. Analyses will be performed with PASW 18.0 . Food diaries will be analysed using FoodWorks 2007 (Xyris Software).The economic evaluation will be conducted using accepted guidelines . To deteThematic analysis will be used to examine transcripts of the interviews with CR staff and the focus groups with study participants. Two researchers will independently code the themes arising and then compare and discuss their coding. For the purpose of triangulation, these researchers will then discuss the themes with an additional researcher. The steps taken in the thematic analysis and the reasons for taking them will be documented to provide an audit trail.Despite the effectiveness of conventional centre-based CR programs, participation rates are low and the majority of people requiring CR are missing out on evidence-based health benefits of lifestyle interventions for cardiac patients. In addition, little research has been conducted on improving health outcomes for the majority of cardiac patients who do not attend CR. This study addresses these gaps in public health practice, firstly by testing an alternative delivery mode for CR, secondly by targeting the entire population of people referred for CR, irrespective of whether they attend a CR program or not, and thirdly by establishing the efficacy of a healthy weight intervention for people with cardiac disease. The economic impact of secondary prevention programs for CVD is an under-researched area. The economic analysis conducted alongside this study will provide important information on the relative costs and benefits of the intervention.This study will show whether the population-based, low contact, high reach intervention tested can promote healthy weight and physical activity among people with CVD in rural and urban settings and whether it can be delivered cost effectively. By replicating the previously proven physical activity only program ,27 in thThe findings of this study will have significant implications for the management of people with CVD. In addition to improving health outcomes for people with cardiac disease, these interventions have the potential to reduce costs and improve access to CR services, particularly for disadvantaged and rural people. They could be a feasible addition to existing services and could also be delivered to people with CVD who have already attended CR programs as a \"maintenance\" program.The authors declare that they have no competing interests.JS drafted the manuscript, contributed to the study design and is coordinating the study. SF, MA-F, MH, PP, AM and AB contributed to the study design, advised on coordination of the study and reviewed the manuscript. All authors read and agreed to the manuscript as written.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2261/10/17/prepub"]}
{"representative": "P < .001) and fat mass (P < .001) was greater in the exercise group. The one-year gain in body mass-adjusted knee extensor and flexor PT at 180\u2009deg/sec was significantly greater in the intervention group compared with the control group . There was no group difference in VJH. In conclusion, the increase in school-based physical education from 60 to 200 minutes per week enhances the development of lean body mass and muscle strength in pre-pubertal boys.This prospective controlled intervention study over 12 months evaluated the effect of exercise on muscular function, physical ability, and body composition in pre-pubertal boys. Sixty-eight boys aged 6\u20138 years, involved in a general school-based exercise program of 40\u2009min per school day (200\u2009min/week), were compared with 46 age-matched boys who participated in the general Swedish physical education curriculum of mean 60\u2009min/week. Baseline and annual changes of body composition were measured by dual energy X-ray absorptiometry (DXA), stature, and body mass by standard equipments, isokinetic peak torque (PT) of the knee extensors, and flexors at 60 and 180\u2009deg/sec by computerized dynamometer (Biodex) and vertical jump height (VJH) by a computerized electronic mat. The annual gain in stature and body mass was similar between the groups whereas the increase in total body and regional lean mass ( Physical activity has been regarded as one of the most important life style factors that could improve a variety of health-related aspects, including musculoskeletal health. But studies have indicated that children and adults in the recent decades have become less physically active , and thePhysical activity includes a variety of activities as it is defined as any bodily movement produced by skeletal muscles that result in energy expenditure . PhysicaIn children and adolescents, it is well established that gains in strength and power are possible following prospective controlled short-term progressive resistance training programs two to three times per week. Reports show that muscle strength, muscle mass, and physical performance improved in both boys and girls \u20139. ThereTo our knowledge there is not an extant literature on general exercise training of longer duration and its effect on neuromuscular development in young children. However, reports show positive effects on fat mass, physical fitness, and performance. A school-based program with expanded physical education lessons (4 lessons/week) during three years was effective in increasing children's physical performance and preventing excessive weight gain . SimilarThese studies provide important information about the musculoskeletal effects of resistance training programs in volunteers or of exercise training programs of longer duration but with obesity or physical fitness as main outcome. However, it still remains unclear whether a long-term, general, and moderately intense exercise program on population level could improve muscle mass and performance in children 6\u20138 years old. We have previously reported that this goal could be reached in Prepubertal girls  but therA population-based general exercise intervention program of moderate intensity was created by increasing the frequency of compulsory school physical education, and not the intensity, as to be able to include all children in the intervention, not only those who could stand a more high intense training. This study was designed to evaluate whether this intervention program could improve body composition, lower extremity muscle strength, and physical performance in Prepubertal boys. We hypothesized that the 12-month program would confer these benefits.The Malm\u00f6 Pediatric Osteoporosis Prevention (POP) Study, is a prospective controlled exercise intervention study designed to annually assess skeletal and muscle development in children from school start onwards , 22. BasThe study design has previously been reported in detail when reporting changes in bone mass , but in In order to ascertain whether there was any selection bias at baseline, we have previously reported that there were no significant differences in the grade 1 examination regarding stature, body mass, and BMI of the boys, when a drop-out analysis compared the study participants and the nonparticipants . FurtherThe intervention program included the general exercise program used within the Swedish school physical education curriculum, supervised by the regular physical educational teachers but with the training increased to 40 minutes per day, corresponding to 200 minutes per week, but no specific registration was done as regard participation rate. Before the study the intervention school had had the same duration of physical education as the control schools. The duration was chosen in order to maximize a range of health-related benefits beyond just the gain in bone mass, which has been shown to respond to shorter bouts of body mass-bearing exercise \u201331. AlsoA questionnaire, previously used in several pediatric studies but slightly modified for the POP study , 22, 33,2 (kg/m2). A research nurse assessed the Tanner  and expressed as the absolute or percentage change from baseline. Analyses of covariance (ANCOVA) were then used to compare the trait-specific annual changes in the groups, and baseline age and baseline peak torque values were included as covariates if there was a significant difference between the groups at baseline. Life style factors prior to and after study start were analysed with Fisher's exact test and Student Ex60) with 80% power and an alpha level of 0.05. The reason we chose PTEx60 as our primary muscle force outcome is that there is evidence in the literature for a greater absolute increase in knee extensor compared to flexor muscle strength from age 9 to 21 years [The study design would detect a minimal difference of 0.123\u2009Nm/kg in the annual change in muscle strength (PT21 years . Trainin21 years .P = .05) (Fl60 and PTFl180 (body mass-adjusted both P < .001) were both higher in the control group  . Furtherol group . Ex180 and PTFl180) were significantly greater in the intervention than in the control group   and PTFl180   . Similar < .001) .This 12-month prospective, controlled, school-based exercise intervention study indicates that an increase in the duration of general moderately intense physical education in the school from 60 to 200 minutes per week is associated with an increased lower limb peak muscle strength gain in Prepubertal boys. A statistically significant difference between the groups can not automatically be transferred to a difference of biological and clinical significance; however, these findings still may have important public health implications as they provide evidence-based data to support the benefit of school-based physical education as an effective strategy to enhance muscular health in Prepubertal boys. There are several reasons why it is beneficial to enhance musculoskeletal health during growth. Bone density, muscle mass, and muscle strength are all traits that play an important role in reducing the risk of a number of chronic musculoskeletal diseases in adulthood , 39 and Several effects may explain the benefits seen in muscle strength from increased physical activity. Training may confer neuromuscular adaptations in conjunction with increases in muscle mass and muscle size, which all increase during puberty in association with the increased secretion of sex steroids , 44. Butin vivo techniques of measuring muscle mass [r2) indicates that the duration of physical activity during the study explained no more than 3.6%\u201314.4% of the variance in the reported traits  and long jump  [Despite reports that general physical training can improve muscle strength in children, there are conflicting reports as to whether these benefits translate into improvements in other physical performance estimates such as athletic performance, VJH, long jump, or sprint speed , 50, 51.P = .10) . The lacP = .10) , it coulAn unexpected finding in our study was the greater annual gain in arm fat mass in the intervention group compared with the controls . Howeverin vivo techniques [There are limitations to this study. This was not a randomized, controlled study, as randomization was refused by the principals, teachers, parents, and children since it was neither feasible nor practical for some children to be given additional exercise during compulsory school hours while others were not. But since all schools had a similar amount of regular school physical education before study start and since there were no differences in anthropometry between participants and nonparticipants or between participants and dropouts, the risk of selection bias seems minimal. Due to lack of resources in our research laboratory, the control group boys were not remeasured until after two years. However, as all the boys remained Prepubertal during the study, it was possible to compare the annual changes between the groups as the development of muscle strength is proportional to the gains in stature and body mass that occur linearly during this period , 55. Thichniques , 48, it chniques . Anotherchniques . FinallyIn conclusion, increasing the amount of moderately intense exercise within the school curriculum physical education to 40 minutes per day provides a feasible strategy to enhance muscle strength in Prepubertal boys. These findings have important clinical implications, as the first two decades in life may represent the most opportune time to reduce the risk of a number of chronic musculoskeletal health conditions . Thus, t", "texts": ["P < .001) and fat mass (P < .001) was greater in the exercise group. The one-year gain in body mass-adjusted knee extensor and flexor PT at 180\u2009deg/sec was significantly greater in the intervention group compared with the control group . There was no group difference in VJH. In conclusion, the increase in school-based physical education from 60 to 200 minutes per week enhances the development of lean body mass and muscle strength in pre-pubertal boys.This prospective controlled intervention study over 12 months evaluated the effect of exercise on muscular function, physical ability, and body composition in pre-pubertal boys. Sixty-eight boys aged 6\u20138 years, involved in a general school-based exercise program of 40\u2009min per school day (200\u2009min/week), were compared with 46 age-matched boys who participated in the general Swedish physical education curriculum of mean 60\u2009min/week. Baseline and annual changes of body composition were measured by dual energy X-ray absorptiometry (DXA), stature, and body mass by standard equipments, isokinetic peak torque (PT) of the knee extensors, and flexors at 60 and 180\u2009deg/sec by computerized dynamometer (Biodex) and vertical jump height (VJH) by a computerized electronic mat. The annual gain in stature and body mass was similar between the groups whereas the increase in total body and regional lean mass ( Physical activity has been regarded as one of the most important life style factors that could improve a variety of health-related aspects, including musculoskeletal health. But studies have indicated that children and adults in the recent decades have become less physically active , and thePhysical activity includes a variety of activities as it is defined as any bodily movement produced by skeletal muscles that result in energy expenditure . PhysicaIn children and adolescents, it is well established that gains in strength and power are possible following prospective controlled short-term progressive resistance training programs two to three times per week. Reports show that muscle strength, muscle mass, and physical performance improved in both boys and girls \u20139. ThereTo our knowledge there is not an extant literature on general exercise training of longer duration and its effect on neuromuscular development in young children. However, reports show positive effects on fat mass, physical fitness, and performance. A school-based program with expanded physical education lessons (4 lessons/week) during three years was effective in increasing children's physical performance and preventing excessive weight gain . SimilarThese studies provide important information about the musculoskeletal effects of resistance training programs in volunteers or of exercise training programs of longer duration but with obesity or physical fitness as main outcome. However, it still remains unclear whether a long-term, general, and moderately intense exercise program on population level could improve muscle mass and performance in children 6\u20138 years old. We have previously reported that this goal could be reached in Prepubertal girls  but therA population-based general exercise intervention program of moderate intensity was created by increasing the frequency of compulsory school physical education, and not the intensity, as to be able to include all children in the intervention, not only those who could stand a more high intense training. This study was designed to evaluate whether this intervention program could improve body composition, lower extremity muscle strength, and physical performance in Prepubertal boys. We hypothesized that the 12-month program would confer these benefits.The Malm\u00f6 Pediatric Osteoporosis Prevention (POP) Study, is a prospective controlled exercise intervention study designed to annually assess skeletal and muscle development in children from school start onwards , 22. BasThe study design has previously been reported in detail when reporting changes in bone mass , but in In order to ascertain whether there was any selection bias at baseline, we have previously reported that there were no significant differences in the grade 1 examination regarding stature, body mass, and BMI of the boys, when a drop-out analysis compared the study participants and the nonparticipants . FurtherThe intervention program included the general exercise program used within the Swedish school physical education curriculum, supervised by the regular physical educational teachers but with the training increased to 40 minutes per day, corresponding to 200 minutes per week, but no specific registration was done as regard participation rate. Before the study the intervention school had had the same duration of physical education as the control schools. The duration was chosen in order to maximize a range of health-related benefits beyond just the gain in bone mass, which has been shown to respond to shorter bouts of body mass-bearing exercise \u201331. AlsoA questionnaire, previously used in several pediatric studies but slightly modified for the POP study , 22, 33,2 (kg/m2). A research nurse assessed the Tanner  and expressed as the absolute or percentage change from baseline. Analyses of covariance (ANCOVA) were then used to compare the trait-specific annual changes in the groups, and baseline age and baseline peak torque values were included as covariates if there was a significant difference between the groups at baseline. Life style factors prior to and after study start were analysed with Fisher's exact test and Student Ex60) with 80% power and an alpha level of 0.05. The reason we chose PTEx60 as our primary muscle force outcome is that there is evidence in the literature for a greater absolute increase in knee extensor compared to flexor muscle strength from age 9 to 21 years [The study design would detect a minimal difference of 0.123\u2009Nm/kg in the annual change in muscle strength (PT21 years . Trainin21 years .P = .05) (Fl60 and PTFl180 (body mass-adjusted both P < .001) were both higher in the control group  . Furtherol group . Ex180 and PTFl180) were significantly greater in the intervention than in the control group   and PTFl180   . Similar < .001) .This 12-month prospective, controlled, school-based exercise intervention study indicates that an increase in the duration of general moderately intense physical education in the school from 60 to 200 minutes per week is associated with an increased lower limb peak muscle strength gain in Prepubertal boys. A statistically significant difference between the groups can not automatically be transferred to a difference of biological and clinical significance; however, these findings still may have important public health implications as they provide evidence-based data to support the benefit of school-based physical education as an effective strategy to enhance muscular health in Prepubertal boys. There are several reasons why it is beneficial to enhance musculoskeletal health during growth. Bone density, muscle mass, and muscle strength are all traits that play an important role in reducing the risk of a number of chronic musculoskeletal diseases in adulthood , 39 and Several effects may explain the benefits seen in muscle strength from increased physical activity. Training may confer neuromuscular adaptations in conjunction with increases in muscle mass and muscle size, which all increase during puberty in association with the increased secretion of sex steroids , 44. Butin vivo techniques of measuring muscle mass [r2) indicates that the duration of physical activity during the study explained no more than 3.6%\u201314.4% of the variance in the reported traits  and long jump  [Despite reports that general physical training can improve muscle strength in children, there are conflicting reports as to whether these benefits translate into improvements in other physical performance estimates such as athletic performance, VJH, long jump, or sprint speed , 50, 51.P = .10) . The lacP = .10) , it coulAn unexpected finding in our study was the greater annual gain in arm fat mass in the intervention group compared with the controls . Howeverin vivo techniques [There are limitations to this study. This was not a randomized, controlled study, as randomization was refused by the principals, teachers, parents, and children since it was neither feasible nor practical for some children to be given additional exercise during compulsory school hours while others were not. But since all schools had a similar amount of regular school physical education before study start and since there were no differences in anthropometry between participants and nonparticipants or between participants and dropouts, the risk of selection bias seems minimal. Due to lack of resources in our research laboratory, the control group boys were not remeasured until after two years. However, as all the boys remained Prepubertal during the study, it was possible to compare the annual changes between the groups as the development of muscle strength is proportional to the gains in stature and body mass that occur linearly during this period , 55. Thichniques , 48, it chniques . Anotherchniques . FinallyIn conclusion, increasing the amount of moderately intense exercise within the school curriculum physical education to 40 minutes per day provides a feasible strategy to enhance muscle strength in Prepubertal boys. These findings have important clinical implications, as the first two decades in life may represent the most opportune time to reduce the risk of a number of chronic musculoskeletal health conditions . Thus, t"]}
{"representative": "Schools are the most frequent target for intervention programs aimed at preventing child obesity; however, the overall effectiveness of these programs has been limited. It has therefore been recommended that interventions target multiple ecological levels  to have greater success in changing risk behaviors for obesity. This study examined the immediate and short-term, sustained effects of the Switch program, which targeted three behaviors  at three ecological levels .Participants were 1,323 children and their parents from 10 schools in two states. Schools were matched and randomly assigned to treatment and control. Measures of the key behaviors and body mass index were collected at baseline, immediately post-intervention, and 6 months post-intervention.d = 0.15 for body mass index at 6 months post-intervention) to large , controlling for baseline levels. There was a significant difference in parent-reported screen time at post-intervention in the experimental group, and this effect was maintained at 6 months post-intervention (a difference of about 2 hours/week). The experimental group also showed a significant increase in parent-reported fruit and vegetable consumption while child-reported fruit and vegetable consumption was marginally significant. At the 6-month follow-up, parent-reported screen time was significantly lower, and parent and child-reported fruit and vegetable consumption was significantly increased. There were no significant effects on pedometer measures of physical activity or body mass index in the experimental group. The intervention effects were moderated by child sex , family involvement (for fruit and vegetable consumption), and child body mass index (for screen time). The perception of change among the experimental group was generally positive with 23% to 62% indicating positive changes in behaviors.The effect sizes of the differences between treatment and control groups ranged between small (Cohen's The results indicate that the Switch program yielded small-to-modest treatment effects for promoting children's fruit and vegetable consumption and minimizing screen time. The Switch program offers promise for use in youth obesity prevention. Pediatric obesity continues to be a serious public health issue with trends indicating that the prevalence of childhood obesity will reach 24% in the USA by 2015 -6. Many Family components are critical for youth obesity prevention programs because parents directly and indirectly influence children's PA and nutrition behaviors at home and also dictate the physical and social environments that are available to their children . SeveralSocial ecological models that target multiple levels of influence have been recommended to address the obesity epidemic ,17. AlthAn established social ecological framework was used to guide the development of the Switch intervention ,27. DetaAll 10 elementary schools in Lakeville, MN and Cedar Rapids, IA, USA, participated in the study. These two school districts were approached due to the requirements of funding agencies. Schools were matched within district by enrollment and percent free/reduced-cost lunch and then randomly assigned to the experimental (three in Cedar Rapids and two in Lakeville) or control (three in Cedar Rapids and two in Lakeville) condition. Prior to participation, parents provided active written consent, and children provided assent.N = 430), fourth (N = 446), and fifth (N = 423) grade children returned consent forms . Participation rates were similar between the experimental and control schools . Forty-seven percent were male  and most (90%) were White, which is representative of their communities. Figure A sample of 1,323 third (Data were collected prior to implementation (baseline), immediately following the intervention (post-intervention), and 6 months post-intervention. Out of 1,323 consented families, 1,288 children (97%) provided data. Of those, 1,196 (93%) provided data at baseline, 1,156 (90%) at post-intervention, and 1,110 (86%) children at 6 months post-intervention. Data were provided by 1,076 children (84%) at both baseline and post-intervention, 1,029 (80%) at both baseline and 6-months post-intervention, and 992 (77%) at all three time points. A total of 1,150 (87%) parents provided data. Of those, 980 (74%) provided data at baseline, 916 (69%) at post-intervention, and 811 (61%) at 6 months post-intervention. Data were provided by 778 parents  at both baseline and post-intervention, 694 (52%) at baseline and 6 months post-intervention, and 631 (48%) at all three time points. Although the percentages varied between waves of data collection, over 80% of parent surveys were completed by mothers, between 7% and 11% were completed by fathers, and the rest were completed by both parents together.The study was approved by the University of Minnesota Institutional Review Board in accordance with the Declaration of Helsinki and the 'Ethical Principles of Psychologists and Code of Conduct' . It is rThe Switch program promoted healthy active lifestyles by encouraging students to 'Switch what you Do, Chew, and View'. The specific DO, VIEW, and CHEW goals were to be active for 60 minutes or more per day, to limit total ST to 2 hours or fewer per day, and to eat five fruits/vegetables or more per day. The intervention utilized overlapping behavioral and environmental strategies employed at multiple ecological levels, and is described in detail elsewhere .The community component was designed to promote awareness of the importance of healthy lifestyles and the prevention of childhood obesity in the targeted communities, and included paid advertising  and unpaid media emphasizing the key messages. Note that both experimental and control participants may have been exposed to the community component. The school component was designed to reinforce the Switch messages and facilitate the family component of the intervention. Teachers were provided with materials and ways to integrate key concepts into their existing curricula. Teachers were not required to participate, since the study was not designed as a school-based (curricular) intervention. Control schools did not receive any school materials. The family component was designed to provide parents (and children) with materials and resources to facilitate the adoption of the healthy target behaviors. Monthly packets containing behavioral tools were provided to assist parents and children in modifying their behaviors. Control families were recruited similarly to experimental families, but received no materials other than the surveys .Data were collected from multiple informants. Baseline assessments (October 2005) included children wearing pedometers for 1 week, completing surveys in classrooms, and having anthropometric measurements taken by school nurses. Parents and teachers also completed surveys. The same measures were conducted immediately post-intervention (May 2006). To measure the maintenance of effects, data were collected approximately 6 months after the end of the intervention (November 2006).Habitual PA was assessed by a pedometer . Accuracy was assessed by having participants walk 10 steps and pedometers that were off by more than 1 step were replaced. Children were instructed to wear the pedometer for 7 consecutive days and to record the time they put the monitor on and off as well as the number of steps accumulated each day. At least 4 days' of data (3 weekdays and 1 day at the weekend) with at least 10 hours/day were required to be considered compliant . The classification of meeting physical activity goals was determined using two published recommendations. The Vincent and Pangrazi  recommenStanding height and weight were measured by trained school nurses using standardized procedures . Body maTime spent viewing TV and playing video games was assessed (independently) by both parents and children, using methods that have been used reliably with parents  and chilParents and children reported on children's FV consumption with items adapted from the National Youth Risk Behavior Survey . The iteAt the conclusion of the program, children and parents in the experimental group were surveyed about noticeable effects of the program on ST, FV, and PA. For each behavior measured, participants reported on a five-point verbally anchored scale the degree to which they perceived their family changed behaviors (ranging from 'a lot more' to 'a lot less').r = 0.47); we therefore standardized scores on each measure and a family involvement score was calculated by averaging parent and child ratings. This composite measure of family involvement allowed for testing whether involvement modified the effect of the intervention, as it could be hypothesized that the effect of the program would be greatest for families who were most involved. High and low involvement groups were created by a median split.Parents and children also reported how much they had participated in the various aspects of the program at post-intervention . Reports of parents and children were found to be significantly correlated  units. Cohen's d is computed by subtracting the average score for the control group (MC) from the average score for the treatment group (MT), and then dividing the difference by the SD on the outcome measure for the sample. We used the standard criteria for ES of small (d = 0.20), medium (d = 0.50), and large effects (d = 0.80) [The primary tests examining differences between baseline and post-intervention and baseline and 6 months post-intervention were conducted using hierarchical multilevel regression analyses to take into account the nested nature of the data (families are nested within schools). An analysis of variance was conducted to test for differences between the schools on the outcome measures at baseline. School had a significant effect for all six outcome variables, explaining from 1% to 11% of the variance in each. Because schools explained a significant amount of variance hierarchical analyses were required and, therefore, subsequent analyses of differences between the treatment and control groups employ variance due to school as the error term in the analyses. This adjustment reduces the degrees of freedom (df) from over 1,300 to 9, but is necessary due to the variability by school and the fact that participants were randomized at the school level. Baseline values were used as covariates to control for any differences between participants on these variables prior to the intervention. This also controls for the observed difference between groups for the child reporting of FV. Further analyses were conducted to provide a more comprehensive evaluation of the intervention. One set of analyses examined whether or not the child's sex moderated the effectiveness of the intervention. These analyses examined whether the intervention had a greater impact for boys or girls. Another set of analyses examined whether family involvement in the programming moderated treatment effects. These analyses specifically examined whether effects were stronger for participants that were highly involved in the program. A final set of analyses tested for moderation of treatment effects by weight status. These analyses specifically examined whether the effects were stronger for overweight or obese youth compared with normal weight youth. As we had directional hypotheses, all reported tests are one-tailed. Effect sizes (ES) were also calculated using Cohen's  = 0.80) . We empl2 . Overall, 19% of children were classified as overweight and 8% were obese. There were significant differences between boys and girls on child-reported and parent-reported weekly ST  = 6.35, P < 0.001, and t (976) = 5.69, P < 0.001, respectively). This was due primarily to video game play. By child report, boys and girls were not significantly different on the number of fruits and/or vegetables they had eaten the previous day. Based on national guidelines (five servings of fruits and vegetables per day) approximately 44% of the children met the recommended guidelines. By parent report, girls ate almost two more servings of fruits and vegetables per week compared with boys  = 2.22, P < 0.05). Only 17% of children met the recommended guidelines of at least five servings a day. As expected, boys tended to have greater step counts than girls (t (823) = 9.01, P < 0.001). Depending on the recommendation used, between 28% and 43% of children achieved the recommended level of PA. Boys and girls were not significantly different on meeting the Vincent and Pangrazi recommendation , but were significantly different on meeting the stricter Tudor-Locke recommendation .Characteristics of the sample at baseline are shown in Table d = 0.15 for BMI at 6 months post-intervention) to large . There was a significant difference in parent-reported ST at post-intervention, and this effect was maintained at 6 months post-intervention (a difference of about 2 hours/week). Child-reported ST was also lower in treatment groups at 6 months post-intervention, but the effect was not significant . There were significant increases in parent-reported FV consumption at post-intervention and 6 months post-intervention. The increase for child-reported consumption was marginally significant at post-intervention and was significant at 6 months post-intervention. PA, as measured by pedometer, at post-intervention and 6 months post-intervention was not statistically significant, although the students in the treatment schools accumulated an average of about 350 more steps per day . Despite a lack of statistical significance, these differences are in the expected direction. At both post-intervention and 6 months post-intervention, the mean BMI values were not significantly different between the treatment and control groups.Tables t (961) = 2.84, P < 0.01) and 6 months post-intervention (t (907) = 1.99, P < 0.05). At both times, the interaction was due to girls in the treatment group reporting greater FV consumption  than girls in the control group . For PA, boys had higher step counts than girls at both post-intervention and 6 months post-intervention, but the interaction with treatment was significant at post-intervention, t (717) = 2.48, P < 0.05, with the program having a significant effect on girls . For BMI, there was a significant sex by treatment interaction at 6 months post-intervention, t (1083) = 2.19, P < 0.05, with boys in the treatment group having a lower BMI (M = 19.1 kg/m2) than boys in the control program (M = 19.4 kg/m2).We examined whether the treatment effects were modified by child sex. These analyses examined the effect of treatment program, sex, and the program by sex interaction on the outcome measures, controlling for baseline values. Although boys had higher total ST than girls (due to more video game play), the interactions between sex and treatment were non-significant. In contrast, the sex by treatment interaction on child-reported FV was significant at post-intervention (t (460) = 4.61, P < 0.001) and at 6 months post-intervention (t (423) = 2.37, P < 0.05), and for parent-reported FV at post-intervention (t (340) = 3.05, P < 0.01), controlling for baseline values. Greater consumption of FV was reported by children who were highly involved (defined by median split) in the treatment program  than for children who were less involved in the treatment program .We examined whether the treatment effects were modified by level of involvement, hypothesizing that the effects of the Switch program would be largest for families who were most highly involved. Significant interactions were found with child-reported FV consumption at post-intervention  than overweight (M = 30.9) or normal weight (M = 29.6) participants, t (1005) = 2.54, P < 0.05. This relation was moderated by a statistically significant interaction, t (1003) = -2.47, P < 0.05, with obese children showing the largest difference in ST between the treatment (M = 30.2) and control (M = 40.8) groups. Thus, the positive effect on child-reported ST was greatest for obese children.We examined whether the treatment effects were modified by child weight, hypothesizing that children who were classified as obese might benefit more from the program. Obese children reported higher ST at post-intervention . Furthermore, these community-based messages were available to both experimental and control families and, therefore, may have minimized differences between the groups.Although over 1,300 families participated in the study, a major limitation of this study was the sample size. Statistical analysis of treatment effects was at the school level due to families being nested within schools and randomization at the school level, resulting in low power to detect differences. Future studies should randomize at the classroom or family level to have greater degrees of freedom . Another limitation is the potential for social desirability to influence the results. It seems unlikely, however, that only the experimental group would be subject to such desirability biases. To reduce the potential effects of bias and method variance, we used multiple informants. An additional limitation was reliance on pedometers to measure PA. Although it seems preferable to have an objective measure, compliance with the requirements was lower than anticipated. Furthermore, the pedometer captures the total amount of PA and does not provide information on the intensity of PA. It is unknown if the amount of time spent in moderate-to-vigorous PA was altered by the intervention. IHere, it is possible that the total number of steps/day was unchanged yet the time spent in moderate-to-vigorous PA increased. Future studies should use PA monitoring tools that capture both the volume and intensity of PA.In conclusion, the results indicate that the Switch program produced modest treatment effects for children's FV and ST. It is noteworthy that the effects remained significant in the 6-month follow-up evaluation as this indicates maintenance of these differences over time. Although levels of BMI were not statistically different between groups, the maintenance of behaviors over time may contribute to reduced risks for overweight in the future. The Switch program which targets multiple behaviors through multiple channels offers promise for use in youth obesity prevention.ADA: American Dietetics Association; BMI: body mass index; ES: effect sizes; FV: fruit and vegetable consumption; PA: physical activity; SD: standard deviation; ST: screen time.The authors declare that they have no competing interests.The Switch program is a program of the National Institute on Media and the Family, a non-profit organization. Several of the authors were employed by the Institute to create the program or to conduct the research , or consulted with the Institute on the design (JCE) or analysis (DWR and RAR).DAG, JCE, DAW, RC, MW, SS, and KF designed the study, established methods and questionnaires, and participated in the coordination of the study. GW provided insight into the conceptual framework of the study. DWR, DAG, and RAR conducted the statistical analyses. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:", "texts": ["Schools are the most frequent target for intervention programs aimed at preventing child obesity; however, the overall effectiveness of these programs has been limited. It has therefore been recommended that interventions target multiple ecological levels  to have greater success in changing risk behaviors for obesity. This study examined the immediate and short-term, sustained effects of the Switch program, which targeted three behaviors  at three ecological levels .Participants were 1,323 children and their parents from 10 schools in two states. Schools were matched and randomly assigned to treatment and control. Measures of the key behaviors and body mass index were collected at baseline, immediately post-intervention, and 6 months post-intervention.d = 0.15 for body mass index at 6 months post-intervention) to large , controlling for baseline levels. There was a significant difference in parent-reported screen time at post-intervention in the experimental group, and this effect was maintained at 6 months post-intervention (a difference of about 2 hours/week). The experimental group also showed a significant increase in parent-reported fruit and vegetable consumption while child-reported fruit and vegetable consumption was marginally significant. At the 6-month follow-up, parent-reported screen time was significantly lower, and parent and child-reported fruit and vegetable consumption was significantly increased. There were no significant effects on pedometer measures of physical activity or body mass index in the experimental group. The intervention effects were moderated by child sex , family involvement (for fruit and vegetable consumption), and child body mass index (for screen time). The perception of change among the experimental group was generally positive with 23% to 62% indicating positive changes in behaviors.The effect sizes of the differences between treatment and control groups ranged between small (Cohen's The results indicate that the Switch program yielded small-to-modest treatment effects for promoting children's fruit and vegetable consumption and minimizing screen time. The Switch program offers promise for use in youth obesity prevention. Pediatric obesity continues to be a serious public health issue with trends indicating that the prevalence of childhood obesity will reach 24% in the USA by 2015 -6. Many Family components are critical for youth obesity prevention programs because parents directly and indirectly influence children's PA and nutrition behaviors at home and also dictate the physical and social environments that are available to their children . SeveralSocial ecological models that target multiple levels of influence have been recommended to address the obesity epidemic ,17. AlthAn established social ecological framework was used to guide the development of the Switch intervention ,27. DetaAll 10 elementary schools in Lakeville, MN and Cedar Rapids, IA, USA, participated in the study. These two school districts were approached due to the requirements of funding agencies. Schools were matched within district by enrollment and percent free/reduced-cost lunch and then randomly assigned to the experimental (three in Cedar Rapids and two in Lakeville) or control (three in Cedar Rapids and two in Lakeville) condition. Prior to participation, parents provided active written consent, and children provided assent.N = 430), fourth (N = 446), and fifth (N = 423) grade children returned consent forms . Participation rates were similar between the experimental and control schools . Forty-seven percent were male  and most (90%) were White, which is representative of their communities. Figure A sample of 1,323 third (Data were collected prior to implementation (baseline), immediately following the intervention (post-intervention), and 6 months post-intervention. Out of 1,323 consented families, 1,288 children (97%) provided data. Of those, 1,196 (93%) provided data at baseline, 1,156 (90%) at post-intervention, and 1,110 (86%) children at 6 months post-intervention. Data were provided by 1,076 children (84%) at both baseline and post-intervention, 1,029 (80%) at both baseline and 6-months post-intervention, and 992 (77%) at all three time points. A total of 1,150 (87%) parents provided data. Of those, 980 (74%) provided data at baseline, 916 (69%) at post-intervention, and 811 (61%) at 6 months post-intervention. Data were provided by 778 parents  at both baseline and post-intervention, 694 (52%) at baseline and 6 months post-intervention, and 631 (48%) at all three time points. Although the percentages varied between waves of data collection, over 80% of parent surveys were completed by mothers, between 7% and 11% were completed by fathers, and the rest were completed by both parents together.The study was approved by the University of Minnesota Institutional Review Board in accordance with the Declaration of Helsinki and the 'Ethical Principles of Psychologists and Code of Conduct' . It is rThe Switch program promoted healthy active lifestyles by encouraging students to 'Switch what you Do, Chew, and View'. The specific DO, VIEW, and CHEW goals were to be active for 60 minutes or more per day, to limit total ST to 2 hours or fewer per day, and to eat five fruits/vegetables or more per day. The intervention utilized overlapping behavioral and environmental strategies employed at multiple ecological levels, and is described in detail elsewhere .The community component was designed to promote awareness of the importance of healthy lifestyles and the prevention of childhood obesity in the targeted communities, and included paid advertising  and unpaid media emphasizing the key messages. Note that both experimental and control participants may have been exposed to the community component. The school component was designed to reinforce the Switch messages and facilitate the family component of the intervention. Teachers were provided with materials and ways to integrate key concepts into their existing curricula. Teachers were not required to participate, since the study was not designed as a school-based (curricular) intervention. Control schools did not receive any school materials. The family component was designed to provide parents (and children) with materials and resources to facilitate the adoption of the healthy target behaviors. Monthly packets containing behavioral tools were provided to assist parents and children in modifying their behaviors. Control families were recruited similarly to experimental families, but received no materials other than the surveys .Data were collected from multiple informants. Baseline assessments (October 2005) included children wearing pedometers for 1 week, completing surveys in classrooms, and having anthropometric measurements taken by school nurses. Parents and teachers also completed surveys. The same measures were conducted immediately post-intervention (May 2006). To measure the maintenance of effects, data were collected approximately 6 months after the end of the intervention (November 2006).Habitual PA was assessed by a pedometer . Accuracy was assessed by having participants walk 10 steps and pedometers that were off by more than 1 step were replaced. Children were instructed to wear the pedometer for 7 consecutive days and to record the time they put the monitor on and off as well as the number of steps accumulated each day. At least 4 days' of data (3 weekdays and 1 day at the weekend) with at least 10 hours/day were required to be considered compliant . The classification of meeting physical activity goals was determined using two published recommendations. The Vincent and Pangrazi  recommenStanding height and weight were measured by trained school nurses using standardized procedures . Body maTime spent viewing TV and playing video games was assessed (independently) by both parents and children, using methods that have been used reliably with parents  and chilParents and children reported on children's FV consumption with items adapted from the National Youth Risk Behavior Survey . The iteAt the conclusion of the program, children and parents in the experimental group were surveyed about noticeable effects of the program on ST, FV, and PA. For each behavior measured, participants reported on a five-point verbally anchored scale the degree to which they perceived their family changed behaviors (ranging from 'a lot more' to 'a lot less').r = 0.47); we therefore standardized scores on each measure and a family involvement score was calculated by averaging parent and child ratings. This composite measure of family involvement allowed for testing whether involvement modified the effect of the intervention, as it could be hypothesized that the effect of the program would be greatest for families who were most involved. High and low involvement groups were created by a median split.Parents and children also reported how much they had participated in the various aspects of the program at post-intervention . Reports of parents and children were found to be significantly correlated  units. Cohen's d is computed by subtracting the average score for the control group (MC) from the average score for the treatment group (MT), and then dividing the difference by the SD on the outcome measure for the sample. We used the standard criteria for ES of small (d = 0.20), medium (d = 0.50), and large effects (d = 0.80) [The primary tests examining differences between baseline and post-intervention and baseline and 6 months post-intervention were conducted using hierarchical multilevel regression analyses to take into account the nested nature of the data (families are nested within schools). An analysis of variance was conducted to test for differences between the schools on the outcome measures at baseline. School had a significant effect for all six outcome variables, explaining from 1% to 11% of the variance in each. Because schools explained a significant amount of variance hierarchical analyses were required and, therefore, subsequent analyses of differences between the treatment and control groups employ variance due to school as the error term in the analyses. This adjustment reduces the degrees of freedom (df) from over 1,300 to 9, but is necessary due to the variability by school and the fact that participants were randomized at the school level. Baseline values were used as covariates to control for any differences between participants on these variables prior to the intervention. This also controls for the observed difference between groups for the child reporting of FV. Further analyses were conducted to provide a more comprehensive evaluation of the intervention. One set of analyses examined whether or not the child's sex moderated the effectiveness of the intervention. These analyses examined whether the intervention had a greater impact for boys or girls. Another set of analyses examined whether family involvement in the programming moderated treatment effects. These analyses specifically examined whether effects were stronger for participants that were highly involved in the program. A final set of analyses tested for moderation of treatment effects by weight status. These analyses specifically examined whether the effects were stronger for overweight or obese youth compared with normal weight youth. As we had directional hypotheses, all reported tests are one-tailed. Effect sizes (ES) were also calculated using Cohen's  = 0.80) . We empl2 . Overall, 19% of children were classified as overweight and 8% were obese. There were significant differences between boys and girls on child-reported and parent-reported weekly ST  = 6.35, P < 0.001, and t (976) = 5.69, P < 0.001, respectively). This was due primarily to video game play. By child report, boys and girls were not significantly different on the number of fruits and/or vegetables they had eaten the previous day. Based on national guidelines (five servings of fruits and vegetables per day) approximately 44% of the children met the recommended guidelines. By parent report, girls ate almost two more servings of fruits and vegetables per week compared with boys  = 2.22, P < 0.05). Only 17% of children met the recommended guidelines of at least five servings a day. As expected, boys tended to have greater step counts than girls (t (823) = 9.01, P < 0.001). Depending on the recommendation used, between 28% and 43% of children achieved the recommended level of PA. Boys and girls were not significantly different on meeting the Vincent and Pangrazi recommendation , but were significantly different on meeting the stricter Tudor-Locke recommendation .Characteristics of the sample at baseline are shown in Table d = 0.15 for BMI at 6 months post-intervention) to large . There was a significant difference in parent-reported ST at post-intervention, and this effect was maintained at 6 months post-intervention (a difference of about 2 hours/week). Child-reported ST was also lower in treatment groups at 6 months post-intervention, but the effect was not significant . There were significant increases in parent-reported FV consumption at post-intervention and 6 months post-intervention. The increase for child-reported consumption was marginally significant at post-intervention and was significant at 6 months post-intervention. PA, as measured by pedometer, at post-intervention and 6 months post-intervention was not statistically significant, although the students in the treatment schools accumulated an average of about 350 more steps per day . Despite a lack of statistical significance, these differences are in the expected direction. At both post-intervention and 6 months post-intervention, the mean BMI values were not significantly different between the treatment and control groups.Tables t (961) = 2.84, P < 0.01) and 6 months post-intervention (t (907) = 1.99, P < 0.05). At both times, the interaction was due to girls in the treatment group reporting greater FV consumption  than girls in the control group . For PA, boys had higher step counts than girls at both post-intervention and 6 months post-intervention, but the interaction with treatment was significant at post-intervention, t (717) = 2.48, P < 0.05, with the program having a significant effect on girls . For BMI, there was a significant sex by treatment interaction at 6 months post-intervention, t (1083) = 2.19, P < 0.05, with boys in the treatment group having a lower BMI (M = 19.1 kg/m2) than boys in the control program (M = 19.4 kg/m2).We examined whether the treatment effects were modified by child sex. These analyses examined the effect of treatment program, sex, and the program by sex interaction on the outcome measures, controlling for baseline values. Although boys had higher total ST than girls (due to more video game play), the interactions between sex and treatment were non-significant. In contrast, the sex by treatment interaction on child-reported FV was significant at post-intervention (t (460) = 4.61, P < 0.001) and at 6 months post-intervention (t (423) = 2.37, P < 0.05), and for parent-reported FV at post-intervention (t (340) = 3.05, P < 0.01), controlling for baseline values. Greater consumption of FV was reported by children who were highly involved (defined by median split) in the treatment program  than for children who were less involved in the treatment program .We examined whether the treatment effects were modified by level of involvement, hypothesizing that the effects of the Switch program would be largest for families who were most highly involved. Significant interactions were found with child-reported FV consumption at post-intervention  than overweight (M = 30.9) or normal weight (M = 29.6) participants, t (1005) = 2.54, P < 0.05. This relation was moderated by a statistically significant interaction, t (1003) = -2.47, P < 0.05, with obese children showing the largest difference in ST between the treatment (M = 30.2) and control (M = 40.8) groups. Thus, the positive effect on child-reported ST was greatest for obese children.We examined whether the treatment effects were modified by child weight, hypothesizing that children who were classified as obese might benefit more from the program. Obese children reported higher ST at post-intervention . Furthermore, these community-based messages were available to both experimental and control families and, therefore, may have minimized differences between the groups.Although over 1,300 families participated in the study, a major limitation of this study was the sample size. Statistical analysis of treatment effects was at the school level due to families being nested within schools and randomization at the school level, resulting in low power to detect differences. Future studies should randomize at the classroom or family level to have greater degrees of freedom . Another limitation is the potential for social desirability to influence the results. It seems unlikely, however, that only the experimental group would be subject to such desirability biases. To reduce the potential effects of bias and method variance, we used multiple informants. An additional limitation was reliance on pedometers to measure PA. Although it seems preferable to have an objective measure, compliance with the requirements was lower than anticipated. Furthermore, the pedometer captures the total amount of PA and does not provide information on the intensity of PA. It is unknown if the amount of time spent in moderate-to-vigorous PA was altered by the intervention. IHere, it is possible that the total number of steps/day was unchanged yet the time spent in moderate-to-vigorous PA increased. Future studies should use PA monitoring tools that capture both the volume and intensity of PA.In conclusion, the results indicate that the Switch program produced modest treatment effects for children's FV and ST. It is noteworthy that the effects remained significant in the 6-month follow-up evaluation as this indicates maintenance of these differences over time. Although levels of BMI were not statistically different between groups, the maintenance of behaviors over time may contribute to reduced risks for overweight in the future. The Switch program which targets multiple behaviors through multiple channels offers promise for use in youth obesity prevention.ADA: American Dietetics Association; BMI: body mass index; ES: effect sizes; FV: fruit and vegetable consumption; PA: physical activity; SD: standard deviation; ST: screen time.The authors declare that they have no competing interests.The Switch program is a program of the National Institute on Media and the Family, a non-profit organization. Several of the authors were employed by the Institute to create the program or to conduct the research , or consulted with the Institute on the design (JCE) or analysis (DWR and RAR).DAG, JCE, DAW, RC, MW, SS, and KF designed the study, established methods and questionnaires, and participated in the coordination of the study. GW provided insight into the conceptual framework of the study. DWR, DAG, and RAR conducted the statistical analyses. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:"]}
{"representative": "Excessive gestational weight gain and postpartum weight retention may predispose women to long-term overweight and other health problems. Intervention studies aiming at preventing excessive pregnancy-related weight gain are needed. The feasibility of implementing such a study protocol in primary health care setting was evaluated in this pilot study.A non-randomized controlled trial was conducted in three intervention and three control maternity and child health clinics in primary health care in Finland. Altogether, 132 pregnant and 92 postpartum women and 23 public health nurses (PHN) participated in the study. The intervention consisted of individual counselling on physical activity and diet at five routine visits to a PHN and of an option for supervised group exercise until 37 weeks' gestation or ten months postpartum. The control clinics continued their usual care. The components of the feasibility evaluation were 1) recruitment and participation, 2) completion of data collection, 3) realization of the intervention and 4) the public health nurses' experiences.1) The recruitment rate was slower than expected and the recruitment period had to be prolonged from the initially planned three months to six months. The average participation rate of eligible women at study enrolment was 77% and the drop-out rate 15%. 2) In total, 99% of the data on weight, physical activity and diet and 96% of the blood samples were obtained. 3) In the intervention clinics, 98% of the counselling sessions were realized, their contents and average durations were as intended, 87% of participants regularly completed the weekly records for physical activity and diet, and the average participation percentage in the group exercise sessions was 45%. 4) The PHNs regarded the extra training as a major advantage and the high additional workload as a disadvantage of the study.The study protocol was mostly feasible to implement, which encourages conducting large trials in comparable settings.Current Controlled Trials ISRCTN21512277 Obesity has become an epidemic throughout the world and increases the risk of several diseases such as type 2 diabetes, cardiovascular disease and certain cancers . For womThe effect of dietary and physical activity habits on gestational weight gain and postpartum weight retention is still unclear . TherefoThe study was conducted in six MCs and CCs in the city of Tampere and the town of H\u00e4meenlinna. The selection of the clinics was based on the clinics' administrative personnel's suggestion for suitable clinics. In the larger trial, a larger number of other clinics will be randomized to intervention and control clinics. The most important reason for randomizing the clinics instead of individuals \u2013 i.e. public health nurses (PHN) or pregnant and postpartum women \u2013 is the likelihood of contamination of the PHNs' counselling practices. In this pilot study, three MCs and CCs volunteered to be intervention clinics and the remaining clinics were treated as control clinics. Feasibility of the study protocol was evaluated separately in the MCs and the CCs, because the larger trial was meant to begin in early pregnancy and continue after delivery.In Finland, women with no earlier deliveries are recommended to make 11\u201315 visits to a PHN and three visits to a physician during pregnancy . In the Fourteen PHNs from the intervention clinics and nine PHNs from the control clinics participated in the study. The PHNs recruited pregnant and postpartum women with no previous deliveries for the study. The exclusion criteria were age under 18 years, type 1 or 2 diabetes mellitus, twin pregnancy, physical disability preventing exercise, substance abuse, treatment or clinical history of any psychiatric illness, otherwise problematic pregnancy (defined by a doctor), inadequate language skills in Finnish and intention to change residence within three months. The PHNs recruited the pregnant women by phone when making an appointment for the first MC visit. The postpartum women were recruited when the PHN visited the participant's home after delivery or on the participant's first visit to the CC. As this was a pilot study, the sample size was not based on power calculations. Instead, the aim was to recruit at least 40 pregnant and 40 postpartum women from the intervention and the control clinics . All participants provided written informed consent to participation. The study was approved by the Ethics Committee of the Pirkanmaa Hospital District.Data collection was similar in the intervention and the control clinics Table . The PHNIn the control clinics, the PHNs continued their usual physical activity and dietary counselling practices. In the intervention clinics, the intervention included individual counselling on physical activity and diet and an option to attend supervised group exercise sessions once a week at a location close to the clinic Figure . The conBefore the study began, the PHNs of the intervention clinics were trained in the counselling procedures and the study arrangements  and the PHNs of the control clinics for the study arrangements  by the research group. All PHNs received a handbook in which the tasks related to each visit were explained. One or two researchers visited each clinic monthly during the study. One supportive meeting was held for the PHNs of the intervention and the control clinics separately. The exercise instructors (n = 10) were trained for the group exercise sessions by the research group .The location of the clinics should not have any effect on the services the clinics provide, because all clinics are supposed to follow the national guidelines for maternity and child health care ,18. In tInformation on the background characteristics and the usual counselling practices of the PHNs was collected by a questionnaire (n = 21) before the PHNs were trained for the study. The responses varied between the six MCs and CCs, but the numbers of PHNs in each clinic were too small to test the statistical significance of the between-clinic differences. Concerning all clinics, 15 (71%) PHNs were aged 40 years or more. The PHNs had either the official degree of PHN (n = 15), midwife (n = 1) or both (n = 5). Of those PHNs who had worked in a MC, the median time of working in a MC was 3.5 (range 1 to 30) years. Likewise, of those PHNs who had worked in a CC, the median time of working in a CC was 13.0 (range 1 to 26) years. The counselling practices varied remarkably between the PHNs, but not between the PHNs of the intervention and the control clinics ,20.In Finland, the clinic attended by each pregnant and postpartum woman is determined by her place of residence. The socioeconomic background of the residents varies between these areas, which may also have affected the characteristics of the participants. There was some variation in the participants' mean age, mean pre-pregnancy BMI, education level, smoking status and the baseline dietary and physical activity habits between the six clinics (results not shown), but the statistical significance of the differences could not be tested due to the small number of participants in each clinic. Information on these variables has been reported earlier in the intervention and the control clinics ,20.The feasibility assessment of the study protocol comprises the following four components. The main indicators and data collection for each component are described below.Information on the achievement of the recruitment aim  within three months, the participation rate of the eligible women and the drop-out rate of participants were obtained from the standardized recruitment forms used by each PHN.The proportion of data obtained on weight development, diet and physical activity was assessed from the number of completed and returned baseline and follow-up questionnaires, maternity cards and postpartum weight measurement forms. Information on the proportion of blood samples obtained was collected from the laboratory records.Concerning the intervention clinics, the realization rate, content and duration of counselling sessions was assessed from the PHNs' counselling cards. Each counselling session was regarded to have been implemented as intended if all essential parts of the counselling card were filled in for the session. The proportion of women completing \u2265 75% of the weekly records for physical activity and diet was obtained from the participants' follow-up notebooks. The mean participation percentage in the group exercise sessions was determined by calculating first the participation percentage of each woman separately from the number of sessions available for her and then averaging the individual participation percentages. Information on participation was obtained from the participant lists kept by the exercise instructors.Information on the PHNs' opinions of the appropriateness of the training for the study was collected using a questionnaire three months after the initiation of the study. The PHNs assessed the training on the Osgood scale (1 = very poor ... 5 = excellent). Additionally, the advantages and the disadvantages of the study for the PHNs were inquired from them by a semi-structured interview within two weeks each PHN's last participant had finished the study.As only 113 participants were enrolled within the three months allocated, the recruitment period was prolonged to six months Table . FinallyThe proportions of data obtained on weight, physical activity and diet were 96\u2013100% and the proportions of blood samples obtained were 95\u201398% Table . The bloIn the intervention clinics, 98% of the counselling sessions were realized as intended and the mean durations of the sessions were as intended Table . All priUsing the 5-point scale, the PHNs of the intervention clinics scored the training for study arrangements 3.4 (sd 1.2), physical activity counselling 3.9 (sd 1.1) and dietary counselling 3.6 (sd 1.1) on average. The PHNs of the control clinics scored the training for study arrangements 3.9 (sd 0.7) on average. Nearly all PHNs regarded the training and the support during the study as sufficient and the researchers' visits to the clinics as useful.The PHNs of the intervention clinics considered the increased knowledge on physical activity and diet and the improved counselling skills to be the major advantages of the study for them. The PHNs of the control clinics appreciated the training they were promised after the study. The major disadvantage reported by the PHNs was that implementation of the study protocol took too much time. The extra time needed for the visits was 40\u201360 min/visit in the intervention clinics and 10\u201320 min/visit in the control clinics on average.We evaluated whether a study protocol aiming at preventing excessive gestational weight gain and postpartum weight retention could be feasibly implemented in the Finnish maternity and child health care system. Integrating a study protocol into the routine functions of primary health care is a demanding task, but we managed to implement the protocol mostly as intended.The overall participation rate was high (77%) and the drop-out rate low (15%). Data on weight development, diet and physical activity was collected very successfully. The proportion of blood samples obtained was extremely high, indicating that collection of this kind of material is possible in studies conducted in real health care settings. In the intervention clinics, almost all counselling sessions were realized as intended and most participants recorded their adherence to the physical activity and dietary plans regularly to their follow-up notebook. This success reflects the PHNs' and the participants' strong commitment to the study, possibly because they were able to see the importance of the study and to see some personal benefits compensating the burden.Although the main experiences were positive, some problems were encountered. The recruitment time needed to be prolonged because the recruitment of the participants was slower than expected. The experience helps in estimating the realistic time needed for recruitment in further studies. The participation rate was slightly lower in the intervention clinics than in the control clinics, which may be related to the participants' background characteristics, to their reluctance to improve or monitor their dietary and physical activity habits or to the PHNs' motivation to recruit participants. In further studies, the way in which study is introduced to the participants and how they are motivated to participate in it will be especially important.The drop-out rate was higher in the intervention MCs than in the other clinics, but the reasons for drop-out seemed quite plausible in all clinics. Pregnancy is often associated with changing residence and, consequently, clinics. For some women who changed residence, we managed to collect the follow-up questionnaires and the maternity cards by mail, thus preventing them dropping out of the study. Some women withdrew for reasons related their pregnancy (such as twin pregnancy or risk for premature delivery) or a stressful life situation. Additionally, as postpartum weight retention was the main outcome for postpartum participants in the effectiveness analyses, we had to exclude women who were pregnant again 10 months after their first delivery. On the other hand, the drop-outs related to the missing blood samples actually occurred due to misunderstanding because the participants would have been allowed to continue the study despite not giving the blood samples. Some participants in the intervention clinics withdrew because they found the data collection too burdensome. Therefore, the amount of data collection should be paid more attention in further studies. For this pilot study, we collected feasibility information, which may not be necessary in further studies.Although the other data collection was successful, NAF samples were obtained from only 41% of the postpartum participants. The sample could not be obtained from women who were still breastfeeding when the collection of the samples was finished. Further studies should allocate a longer time period for collection of NAF samples. As NAF samples are not routinely collected in health care, some women may have been suspicious or afraid of giving them. To minimize the number of women refusing to give the sample, the methods of collecting NAF sample should be described in detail to the participants beforehand. However, the most frequent reason for a missing NAF sample was that no NAF could be obtained from the breast despite attempts. Other studies have also reported difficulties in obtaining NAF . TherefoThe average participation percentage in the group exercise sessions was relatively low, especially among the pregnant participants. No information is available on the reasons why the women did not participate more often. The reasons have been discussed earlier  and theyThe quality and adequacy of training of the PHNs will be of crucial importance in future studies, since the PHNs regarded the increased knowledge about physical activity and diet as well as improved counselling skills as the major advantage of participating in the study. However, as the PHNs found that the implementation of the study protocol was time-consuming, the time spent on study arrangements and all paper flow should be kept to a minimum in further studies. A risk group approach should also be considered to limit the PHNs' workload and to better target counselling at those in need. Allocating shorter times for counselling may impair the effectiveness of the intervention.A major strength of the study was that the counselling was implemented during routine visits to primary health care instead of using extra study personnel. Using this approach, we also aimed at developing counselling practices, which could be incorporated into real health care situations. Safety issues are especially important when implementing interventions among pregnant and postpartum women. Therefore, another major strength of the study was that no statistically significant differences were observed in the incidence of selected adverse events between the intervention and the control groups . Nor werOne limitation of the pilot study was that we were not able to randomize the clinics, which may have caused some baseline differences between the participants of the intervention and the control clinics ,20. HoweImplementation of the study protocol proved to be feasible in this setting, which encourages the undertaking of a large study in Finland and possibly also in other countries with maternity and child health care services funded by public taxation . Such beThe authors declare that they have no competing interests.TIK participated in the development of the study design and the intervention protocols  and in the acquisition and analysis of the data. MA participated in the development of the study design and the intervention protocols  and in the acquisition of data. PK and EW were involved in the development of the study design. KO participated in the development of the intervention protocols (group exercise sessions) and in the acquisition of the data. KM participated in the development of the intervention protocols (laboratory issues) and in the acquisition of the data. MF was involved in the development of the study design and the intervention protocols. RL was the principal researcher and responsible for the study concept and design and she participated in the development of the intervention protocols. All authors participated in the interpretation of the data and preparation of the manuscript. Additionally, all authors have read and approved the final manuscript.The pre-publication history for this paper can be accessed here:", "texts": ["Excessive gestational weight gain and postpartum weight retention may predispose women to long-term overweight and other health problems. Intervention studies aiming at preventing excessive pregnancy-related weight gain are needed. The feasibility of implementing such a study protocol in primary health care setting was evaluated in this pilot study.A non-randomized controlled trial was conducted in three intervention and three control maternity and child health clinics in primary health care in Finland. Altogether, 132 pregnant and 92 postpartum women and 23 public health nurses (PHN) participated in the study. The intervention consisted of individual counselling on physical activity and diet at five routine visits to a PHN and of an option for supervised group exercise until 37 weeks' gestation or ten months postpartum. The control clinics continued their usual care. The components of the feasibility evaluation were 1) recruitment and participation, 2) completion of data collection, 3) realization of the intervention and 4) the public health nurses' experiences.1) The recruitment rate was slower than expected and the recruitment period had to be prolonged from the initially planned three months to six months. The average participation rate of eligible women at study enrolment was 77% and the drop-out rate 15%. 2) In total, 99% of the data on weight, physical activity and diet and 96% of the blood samples were obtained. 3) In the intervention clinics, 98% of the counselling sessions were realized, their contents and average durations were as intended, 87% of participants regularly completed the weekly records for physical activity and diet, and the average participation percentage in the group exercise sessions was 45%. 4) The PHNs regarded the extra training as a major advantage and the high additional workload as a disadvantage of the study.The study protocol was mostly feasible to implement, which encourages conducting large trials in comparable settings.Current Controlled Trials ISRCTN21512277 Obesity has become an epidemic throughout the world and increases the risk of several diseases such as type 2 diabetes, cardiovascular disease and certain cancers . For womThe effect of dietary and physical activity habits on gestational weight gain and postpartum weight retention is still unclear . TherefoThe study was conducted in six MCs and CCs in the city of Tampere and the town of H\u00e4meenlinna. The selection of the clinics was based on the clinics' administrative personnel's suggestion for suitable clinics. In the larger trial, a larger number of other clinics will be randomized to intervention and control clinics. The most important reason for randomizing the clinics instead of individuals \u2013 i.e. public health nurses (PHN) or pregnant and postpartum women \u2013 is the likelihood of contamination of the PHNs' counselling practices. In this pilot study, three MCs and CCs volunteered to be intervention clinics and the remaining clinics were treated as control clinics. Feasibility of the study protocol was evaluated separately in the MCs and the CCs, because the larger trial was meant to begin in early pregnancy and continue after delivery.In Finland, women with no earlier deliveries are recommended to make 11\u201315 visits to a PHN and three visits to a physician during pregnancy . In the Fourteen PHNs from the intervention clinics and nine PHNs from the control clinics participated in the study. The PHNs recruited pregnant and postpartum women with no previous deliveries for the study. The exclusion criteria were age under 18 years, type 1 or 2 diabetes mellitus, twin pregnancy, physical disability preventing exercise, substance abuse, treatment or clinical history of any psychiatric illness, otherwise problematic pregnancy (defined by a doctor), inadequate language skills in Finnish and intention to change residence within three months. The PHNs recruited the pregnant women by phone when making an appointment for the first MC visit. The postpartum women were recruited when the PHN visited the participant's home after delivery or on the participant's first visit to the CC. As this was a pilot study, the sample size was not based on power calculations. Instead, the aim was to recruit at least 40 pregnant and 40 postpartum women from the intervention and the control clinics . All participants provided written informed consent to participation. The study was approved by the Ethics Committee of the Pirkanmaa Hospital District.Data collection was similar in the intervention and the control clinics Table . The PHNIn the control clinics, the PHNs continued their usual physical activity and dietary counselling practices. In the intervention clinics, the intervention included individual counselling on physical activity and diet and an option to attend supervised group exercise sessions once a week at a location close to the clinic Figure . The conBefore the study began, the PHNs of the intervention clinics were trained in the counselling procedures and the study arrangements  and the PHNs of the control clinics for the study arrangements  by the research group. All PHNs received a handbook in which the tasks related to each visit were explained. One or two researchers visited each clinic monthly during the study. One supportive meeting was held for the PHNs of the intervention and the control clinics separately. The exercise instructors (n = 10) were trained for the group exercise sessions by the research group .The location of the clinics should not have any effect on the services the clinics provide, because all clinics are supposed to follow the national guidelines for maternity and child health care ,18. In tInformation on the background characteristics and the usual counselling practices of the PHNs was collected by a questionnaire (n = 21) before the PHNs were trained for the study. The responses varied between the six MCs and CCs, but the numbers of PHNs in each clinic were too small to test the statistical significance of the between-clinic differences. Concerning all clinics, 15 (71%) PHNs were aged 40 years or more. The PHNs had either the official degree of PHN (n = 15), midwife (n = 1) or both (n = 5). Of those PHNs who had worked in a MC, the median time of working in a MC was 3.5 (range 1 to 30) years. Likewise, of those PHNs who had worked in a CC, the median time of working in a CC was 13.0 (range 1 to 26) years. The counselling practices varied remarkably between the PHNs, but not between the PHNs of the intervention and the control clinics ,20.In Finland, the clinic attended by each pregnant and postpartum woman is determined by her place of residence. The socioeconomic background of the residents varies between these areas, which may also have affected the characteristics of the participants. There was some variation in the participants' mean age, mean pre-pregnancy BMI, education level, smoking status and the baseline dietary and physical activity habits between the six clinics (results not shown), but the statistical significance of the differences could not be tested due to the small number of participants in each clinic. Information on these variables has been reported earlier in the intervention and the control clinics ,20.The feasibility assessment of the study protocol comprises the following four components. The main indicators and data collection for each component are described below.Information on the achievement of the recruitment aim  within three months, the participation rate of the eligible women and the drop-out rate of participants were obtained from the standardized recruitment forms used by each PHN.The proportion of data obtained on weight development, diet and physical activity was assessed from the number of completed and returned baseline and follow-up questionnaires, maternity cards and postpartum weight measurement forms. Information on the proportion of blood samples obtained was collected from the laboratory records.Concerning the intervention clinics, the realization rate, content and duration of counselling sessions was assessed from the PHNs' counselling cards. Each counselling session was regarded to have been implemented as intended if all essential parts of the counselling card were filled in for the session. The proportion of women completing \u2265 75% of the weekly records for physical activity and diet was obtained from the participants' follow-up notebooks. The mean participation percentage in the group exercise sessions was determined by calculating first the participation percentage of each woman separately from the number of sessions available for her and then averaging the individual participation percentages. Information on participation was obtained from the participant lists kept by the exercise instructors.Information on the PHNs' opinions of the appropriateness of the training for the study was collected using a questionnaire three months after the initiation of the study. The PHNs assessed the training on the Osgood scale (1 = very poor ... 5 = excellent). Additionally, the advantages and the disadvantages of the study for the PHNs were inquired from them by a semi-structured interview within two weeks each PHN's last participant had finished the study.As only 113 participants were enrolled within the three months allocated, the recruitment period was prolonged to six months Table . FinallyThe proportions of data obtained on weight, physical activity and diet were 96\u2013100% and the proportions of blood samples obtained were 95\u201398% Table . The bloIn the intervention clinics, 98% of the counselling sessions were realized as intended and the mean durations of the sessions were as intended Table . All priUsing the 5-point scale, the PHNs of the intervention clinics scored the training for study arrangements 3.4 (sd 1.2), physical activity counselling 3.9 (sd 1.1) and dietary counselling 3.6 (sd 1.1) on average. The PHNs of the control clinics scored the training for study arrangements 3.9 (sd 0.7) on average. Nearly all PHNs regarded the training and the support during the study as sufficient and the researchers' visits to the clinics as useful.The PHNs of the intervention clinics considered the increased knowledge on physical activity and diet and the improved counselling skills to be the major advantages of the study for them. The PHNs of the control clinics appreciated the training they were promised after the study. The major disadvantage reported by the PHNs was that implementation of the study protocol took too much time. The extra time needed for the visits was 40\u201360 min/visit in the intervention clinics and 10\u201320 min/visit in the control clinics on average.We evaluated whether a study protocol aiming at preventing excessive gestational weight gain and postpartum weight retention could be feasibly implemented in the Finnish maternity and child health care system. Integrating a study protocol into the routine functions of primary health care is a demanding task, but we managed to implement the protocol mostly as intended.The overall participation rate was high (77%) and the drop-out rate low (15%). Data on weight development, diet and physical activity was collected very successfully. The proportion of blood samples obtained was extremely high, indicating that collection of this kind of material is possible in studies conducted in real health care settings. In the intervention clinics, almost all counselling sessions were realized as intended and most participants recorded their adherence to the physical activity and dietary plans regularly to their follow-up notebook. This success reflects the PHNs' and the participants' strong commitment to the study, possibly because they were able to see the importance of the study and to see some personal benefits compensating the burden.Although the main experiences were positive, some problems were encountered. The recruitment time needed to be prolonged because the recruitment of the participants was slower than expected. The experience helps in estimating the realistic time needed for recruitment in further studies. The participation rate was slightly lower in the intervention clinics than in the control clinics, which may be related to the participants' background characteristics, to their reluctance to improve or monitor their dietary and physical activity habits or to the PHNs' motivation to recruit participants. In further studies, the way in which study is introduced to the participants and how they are motivated to participate in it will be especially important.The drop-out rate was higher in the intervention MCs than in the other clinics, but the reasons for drop-out seemed quite plausible in all clinics. Pregnancy is often associated with changing residence and, consequently, clinics. For some women who changed residence, we managed to collect the follow-up questionnaires and the maternity cards by mail, thus preventing them dropping out of the study. Some women withdrew for reasons related their pregnancy (such as twin pregnancy or risk for premature delivery) or a stressful life situation. Additionally, as postpartum weight retention was the main outcome for postpartum participants in the effectiveness analyses, we had to exclude women who were pregnant again 10 months after their first delivery. On the other hand, the drop-outs related to the missing blood samples actually occurred due to misunderstanding because the participants would have been allowed to continue the study despite not giving the blood samples. Some participants in the intervention clinics withdrew because they found the data collection too burdensome. Therefore, the amount of data collection should be paid more attention in further studies. For this pilot study, we collected feasibility information, which may not be necessary in further studies.Although the other data collection was successful, NAF samples were obtained from only 41% of the postpartum participants. The sample could not be obtained from women who were still breastfeeding when the collection of the samples was finished. Further studies should allocate a longer time period for collection of NAF samples. As NAF samples are not routinely collected in health care, some women may have been suspicious or afraid of giving them. To minimize the number of women refusing to give the sample, the methods of collecting NAF sample should be described in detail to the participants beforehand. However, the most frequent reason for a missing NAF sample was that no NAF could be obtained from the breast despite attempts. Other studies have also reported difficulties in obtaining NAF . TherefoThe average participation percentage in the group exercise sessions was relatively low, especially among the pregnant participants. No information is available on the reasons why the women did not participate more often. The reasons have been discussed earlier  and theyThe quality and adequacy of training of the PHNs will be of crucial importance in future studies, since the PHNs regarded the increased knowledge about physical activity and diet as well as improved counselling skills as the major advantage of participating in the study. However, as the PHNs found that the implementation of the study protocol was time-consuming, the time spent on study arrangements and all paper flow should be kept to a minimum in further studies. A risk group approach should also be considered to limit the PHNs' workload and to better target counselling at those in need. Allocating shorter times for counselling may impair the effectiveness of the intervention.A major strength of the study was that the counselling was implemented during routine visits to primary health care instead of using extra study personnel. Using this approach, we also aimed at developing counselling practices, which could be incorporated into real health care situations. Safety issues are especially important when implementing interventions among pregnant and postpartum women. Therefore, another major strength of the study was that no statistically significant differences were observed in the incidence of selected adverse events between the intervention and the control groups . Nor werOne limitation of the pilot study was that we were not able to randomize the clinics, which may have caused some baseline differences between the participants of the intervention and the control clinics ,20. HoweImplementation of the study protocol proved to be feasible in this setting, which encourages the undertaking of a large study in Finland and possibly also in other countries with maternity and child health care services funded by public taxation . Such beThe authors declare that they have no competing interests.TIK participated in the development of the study design and the intervention protocols  and in the acquisition and analysis of the data. MA participated in the development of the study design and the intervention protocols  and in the acquisition of data. PK and EW were involved in the development of the study design. KO participated in the development of the intervention protocols (group exercise sessions) and in the acquisition of the data. KM participated in the development of the intervention protocols (laboratory issues) and in the acquisition of the data. MF was involved in the development of the study design and the intervention protocols. RL was the principal researcher and responsible for the study concept and design and she participated in the development of the intervention protocols. All authors participated in the interpretation of the data and preparation of the manuscript. Additionally, all authors have read and approved the final manuscript.The pre-publication history for this paper can be accessed here:"]}
{"representative": "Obesity is a major cause of preventable death in Australia with prevalence increasing at an alarming rate. Of particular concern is that approximately 68% of men are overweight/obese, yet are notoriously difficult to engage in weight loss programs, despite being more susceptible than women to adverse weight-related outcomes. There is a need to develop and evaluate obesity treatment programs that target and appeal to men. The primary aim of this study is to evaluate the efficacy of two relatively low intensity weight loss programs developed specifically for men.2); no participation in other weight loss programs during the study; pass a health-screening questionnaire and pre-exercise risk assessment; available for assessment sessions; access to a computer with e-mail and Internet facilities; and own a mobile phone. Men were recruited to the SHED-IT  study via the media and emails sent to male dominated workplaces. Men were stratified by BMI category  and randomised to one of three groups: (1) SHED-IT Resources - provision of materials  with embedded behaviour change strategies to support weight loss; (2) SHED-IT Online - same materials as SHED-IT Resources plus access to and instruction on how to use the study website; (3) Wait-list Control. The intervention programs are three months long with outcome measures taken by assessors blinded to group allocation at baseline, and 3- and 6-months post baseline. Outcome measures include: weight (primary outcome), % body fat, waist circumference, blood pressure, resting heart rate, objectively measured physical activity, self-reported dietary intake, sedentary behaviour, physical activity and dietary cognitions, sleepiness, quality of life, and perceived sexual health. Generalised linear mixed models will be used to assess all outcomes for the impact of group , time  and the group-by-time interaction. These three terms will form the base model. 'Intention-to-treat' analysis will include all randomised participants.The study design is an assessor blinded, parallel-group randomised controlled trial that recruited 159 overweight and obese men in Newcastle, Australia. Inclusion criteria included: BMI 25-40  Obesity is a major cause of preventable death and is associated with a range of negative physiological and psychological consequences . In addiGut-Buster study was unique when published 14 years ago /height[m]Waist circumference was measured at two points: (i) level with the umbilicus, and (ii) at the largest circumference between the lower costal border and the umbilicus. Two measures were taken at each site, with accepted values within 0.5 cm. Further measures were taken if measurements were outside the acceptable range. The average of the two acceptable measures will be reported. To ensure follow up measurements were taken from the same location, the distances between the sternal notch and both waist circumference points were recorded. Each measurement was recorded with a non-extensible steel tape . This measure will be taken at each time point by one of two assessors with Level 1 Anthropometry qualifications to improve reliability.Blood pressure and resting heart rate were measured using NISSEI/DS-105E digital electronic blood pressure monitors  under standardised procedures. Participants were seated for five minutes before the first blood pressure measurement and a rest period of two minutes between measures was used. Blood pressure was measured three times. Further measurements were taken if the blood pressure or resting heart rate values fell outside of the acceptable ranges i.e. Systolic within 10 mmHg, diastolic within 10 mmHg (preferably 5 mmHg) and resting heart rate within 5 bpm. The mean of the two closest systolic pressures and the diastolic pressure paired to them will be reported. The mean of the two lowest resting pulse pressures will be used.Bioimpedance was used for the assessment of body composition, including fat mass, fat free mass and total body water. Body composition was assessed by the InBody720 , a multi-frequency bioimpedance device featuring an eight-point tactile electrode system. This device has been shown to be a valid and reliable device for body composition assessment ,36.Physical activity was objectively measured using pedometers . Participants were sent pedometers in the mail 1-2 weeks prior to the baseline assessment and will be provided with the pedometer at follow-up assessments. Participants were instructed on how to attach the pedometers (at the waist on the right hand side) and asked to remove the pedometers only when sleeping, when the pedometer might get wet  or during contact sports. Participants were asked to wear the pedometers for seven consecutive days and keep to their normal routine. At the end of the day participants were instructed to record their steps on a pedometer record sheet and reset their pedometers to zero. Participants were instructed to note down if they did an activity like cycling, swimming, contact sports or another activity that does not involve stepping and include details (type of activity and duration), or if they forgot to wear their pedometer. Participants will be included in all analyses if they have completed at least four weekdays of pedometer monitoring. The average of existing days will be imputed for participants who have included at least four days of data.Dietary intake was assessed using the Australian Eating Survey (AES). AES is a 120-item semi-quantitative Food Frequency Questionnaire (FFQ), used previously in Australian youth up to 16 years  and currNutrient intakes from the AES will be computed from the most current food composition database of Australian foods available, the Australian AusNut 1999 database (All Foods) Revision 17 and AusFoods (Brands) Revision 5  to generate individual mean daily macro-and micro-nutrient intakes. The AES includes questions about the total number of daily serves of fruit, vegetables, bread, dairy products, eggs, fat spreads, sweetened beverages and snack foods, as well as asking the type of bread, dairy products and fat spreads used. Twelve questions relate to food-related behaviours, including items on frequency of take-away food consumption and eating while watching television.Portion size was assessed using portion size photographs from the Dietary Questionnaire for Epidemiological Studies Version 2 (DQES v2), FFQ from the Cancer Council Victoria . These pAlcohol consumption was measured using an adaptation of the Australian Government Department of Veteran Affairs, Alcohol Use Disorders Identification Test (AUDIT) 2009 . This inPhysical activity and nutrition beliefs were assessed using a number of validated instruments: physical activity self efficacy , physicaSedentary behaviours were assessed using an adaptation of the Sitting Questionnaire, which has been shown to be both a valid and reliable measure of sitting time in various domains ,52.Quality of Life and general health was assessed using the UK short form 12 (SF-12) questionnaire ,54.Daytime Sleepiness was assessed using the Epworth sleepiness scale which is a valid measure of general daytime sleepiness .Sexual Function was assessed using the International Index of Erectile Function-5 (IIEF-5) questionnaire which has been shown to be a valid measure of erectile function .Adherence to self-monitoring  will be calculated from diaries for both treatment arms. In addition to this, men will hand in their SHED-IT support booklet at the 3- and 6-month time points, to be photocopied and posted back. We will also administer a detailed process questionnaire to examine men's perceptions of the SHED-IT program. This will include scales, individual items and open-ended questions that require men to describe the strengths and weaknesses of the program along with their suggestions for improvement. The process evaluation will cover issues such as the study feasibility, opinion of the allocated study group, use and appraisal of components of each intervention and their levels of overall satisfaction. We will also ask how much participants would be willing to pay for the offered intervention. The process evaluation will be administered at the 6-month time point.The sample size calculation is based on the primary outcome of weight loss at 6 months, which we have assumed will have a standard deviation of 5 kg ,57. ThirParticipants were randomised at an individual level by the trial statistician who will not have any contact with participants during the trial. Allocation was stratified by BMI category calculated at the baseline assessment  and the allocation sequence within strata was generated by a computer-based random number-producing algorithm in block lengths of six. Randomisation codes are stored in a restricted computer folder, which is not accessible by those assessing participants, those involved in group allocating participants or those participating in data entry for the study. Complete separation was achieved between the statistician who generated the randomisation sequence and those who concealed allocation from those involved in implementation of assignments.Study information for the three different groups was pre-packed into identical black plastic opaque envelopes and consecutively numbered within the three BMI categories and ordered according to the randomisation schedule. The packing and sequencing of these envelopes was completed by a research assistant who was not involved in enrolment, assessment or allocation of participants. Study participants completed all baseline assessments before proceeding to a separate room to meet with a research assistant who was not involved with the baseline assessments. The allocation sequence was concealed during this process. Participants' BMI category was calculated from the baseline measurements and the participant was allocated the next available number in that BMI category before being provided with their information pack. At this point the envelope was opened by the research assistant and details of the particular information pack were provided to the participant using a standardised protocol.Randomisation was undertaken by the trial statistician and measures will be taken by trained staff at all times points. In order to ensure accurate and consistent measurements, the study weight scale was professionally calibrated and the height scale checked and recalibrated daily before measurements commenced. All assessments were completed by staff blinded to treatment allocation. When men are contacted (via phone and email) to book in for follow-up assessments they will be asked not to inform data collection personnel of their group allocation. Data will be entered by research assistants blind to group allocation and a program of plausibility checks will be used to identify unrealistic values. The primary outcome measure (weight) will be double entered to ensure accuracy and a random 20% sample of all other measures will also be double entered.t tests for continuous variables and chi-squared (\u03c72) tests for categorical variables. The significance level for the comparison of baseline characteristics will be set at 0.05.Analyses will be performed using Stata Version 11 or later. All variables will be checked for plausibility and missing values. Data will be presented as mean (sd) for continuous variables and counts (percentages) for categorical variables. Differences between groups at randomisation and characteristics of completers versus dropouts will be tested using independent Resources vs. Control; Online vs. Control; and Resources vs. Online). The independent variables in the model will include a variable for treatment group, time  and the group-by-time interaction. The model will also include a term for the stratifying variable of BMI group at baseline. The coefficient and p-value for the group-by-6 month interaction term will be used to determine the efficacy of the interventions. Similar models will be used to examine differences in change in other outcome measures.A series of Generalised Linear Mixed Models (GLMMs) with a random intercept for individual will be used to test for differences between treatment groups in the mean level of weight after treatment. Separate models will be fit for each of the pair-wise comparisons  and of interest will be the 3 way interaction of treatment group by time by SES. We will also examine a range of secondary outcomes to support the primary outcome . Additional exploratory models will be fitted to examine if the men who have the greatest reduction in weight are also those who have the greatest improvements in the secondary outcomes.Statistical significance of the primary efficacy analysis (3 pair-wise comparisons) will be based on Hochberg's multiple testing procedure with the family wise error rate held at 5%. All secondary hypothesis tests will be performed using a 2-sided 5% significance level. In addition, linear regression and GLMMs will be used to describe relationships among the various dependent and independent variables.Online and Resources component. Men who complied well with the assigned treatment, defined as completion of requested daily eating and exercise diaries (n >40) over the 3-month period and weekly check-ins (n >10). Results of the per-protocol group will be compared with non-compliers in each group i.e. those who did not meet the above adherence recommendations.A per protocol analysis will also be conducted and include men who complied with treatment from the The aim of this study is to evaluate the efficacy of two 'low dose' weight loss programs developed specifically for men that could be widely and inexpensively implemented throughout Australia. We will determine whether these innovative approaches to obesity treatment will result in greater initial weight loss and improvements in cardiovascular risk factors compared to a Control group in a community sample of overweight men. There is an urgent need to develop and evaluate novel approaches to weight loss that attract and engage large numbers of men. We will also determine whether web-based support is more effective than resources alone. This study is designed to address the gap in service provision of community-based programs for overweight and obese men. There is limited evidence to guide the design of effective obesity treatment programs for overweight men that would be sustainable in most health care settings that do not require multiple visits to treatment centres.Our trial targets a national health priority in Australia and focuses on a high-risk under studied population. To successfully combat the obesity epidemic, clinicians and health care systems require feasible, effective and evidence-based treatment options that can be provided to large numbers of men. This randomised controlled trial will test alternative, evidence-based and theoretically driven, easily disseminated strategies specifically for weight loss in men. The interventions are all designed so they could serve as prototypes for rapid translation of research findings into widely available practical applications and widespread implementation in both the public health and medical care sectors. If successful, this project will reduce the negative health, economic and social consequences of obesity through clinically meaningful risk reduction in large numbers of overweight men.The authors declare that they have no competing interests.The study chief investigators PJM, RC, CEC, PM, RCP and Associate Investigator JMW were responsible for identifying the research question, design of the study, obtaining ethics approval, the acquisition of funding and overseeing study implementation. Associate Investigator TB and research assistants NB, MDY, EJA and KLS have contributed to development of intervention materials, recruiting participants and/or study implementation. All authors were responsible for the drafting of this manuscript and have read and approved the final version.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2458/10/701/prepub", "texts": ["Obesity is a major cause of preventable death in Australia with prevalence increasing at an alarming rate. Of particular concern is that approximately 68% of men are overweight/obese, yet are notoriously difficult to engage in weight loss programs, despite being more susceptible than women to adverse weight-related outcomes. There is a need to develop and evaluate obesity treatment programs that target and appeal to men. The primary aim of this study is to evaluate the efficacy of two relatively low intensity weight loss programs developed specifically for men.2); no participation in other weight loss programs during the study; pass a health-screening questionnaire and pre-exercise risk assessment; available for assessment sessions; access to a computer with e-mail and Internet facilities; and own a mobile phone. Men were recruited to the SHED-IT  study via the media and emails sent to male dominated workplaces. Men were stratified by BMI category  and randomised to one of three groups: (1) SHED-IT Resources - provision of materials  with embedded behaviour change strategies to support weight loss; (2) SHED-IT Online - same materials as SHED-IT Resources plus access to and instruction on how to use the study website; (3) Wait-list Control. The intervention programs are three months long with outcome measures taken by assessors blinded to group allocation at baseline, and 3- and 6-months post baseline. Outcome measures include: weight (primary outcome), % body fat, waist circumference, blood pressure, resting heart rate, objectively measured physical activity, self-reported dietary intake, sedentary behaviour, physical activity and dietary cognitions, sleepiness, quality of life, and perceived sexual health. Generalised linear mixed models will be used to assess all outcomes for the impact of group , time  and the group-by-time interaction. These three terms will form the base model. 'Intention-to-treat' analysis will include all randomised participants.The study design is an assessor blinded, parallel-group randomised controlled trial that recruited 159 overweight and obese men in Newcastle, Australia. Inclusion criteria included: BMI 25-40  Obesity is a major cause of preventable death and is associated with a range of negative physiological and psychological consequences . In addiGut-Buster study was unique when published 14 years ago /height[m]Waist circumference was measured at two points: (i) level with the umbilicus, and (ii) at the largest circumference between the lower costal border and the umbilicus. Two measures were taken at each site, with accepted values within 0.5 cm. Further measures were taken if measurements were outside the acceptable range. The average of the two acceptable measures will be reported. To ensure follow up measurements were taken from the same location, the distances between the sternal notch and both waist circumference points were recorded. Each measurement was recorded with a non-extensible steel tape . This measure will be taken at each time point by one of two assessors with Level 1 Anthropometry qualifications to improve reliability.Blood pressure and resting heart rate were measured using NISSEI/DS-105E digital electronic blood pressure monitors  under standardised procedures. Participants were seated for five minutes before the first blood pressure measurement and a rest period of two minutes between measures was used. Blood pressure was measured three times. Further measurements were taken if the blood pressure or resting heart rate values fell outside of the acceptable ranges i.e. Systolic within 10 mmHg, diastolic within 10 mmHg (preferably 5 mmHg) and resting heart rate within 5 bpm. The mean of the two closest systolic pressures and the diastolic pressure paired to them will be reported. The mean of the two lowest resting pulse pressures will be used.Bioimpedance was used for the assessment of body composition, including fat mass, fat free mass and total body water. Body composition was assessed by the InBody720 , a multi-frequency bioimpedance device featuring an eight-point tactile electrode system. This device has been shown to be a valid and reliable device for body composition assessment ,36.Physical activity was objectively measured using pedometers . Participants were sent pedometers in the mail 1-2 weeks prior to the baseline assessment and will be provided with the pedometer at follow-up assessments. Participants were instructed on how to attach the pedometers (at the waist on the right hand side) and asked to remove the pedometers only when sleeping, when the pedometer might get wet  or during contact sports. Participants were asked to wear the pedometers for seven consecutive days and keep to their normal routine. At the end of the day participants were instructed to record their steps on a pedometer record sheet and reset their pedometers to zero. Participants were instructed to note down if they did an activity like cycling, swimming, contact sports or another activity that does not involve stepping and include details (type of activity and duration), or if they forgot to wear their pedometer. Participants will be included in all analyses if they have completed at least four weekdays of pedometer monitoring. The average of existing days will be imputed for participants who have included at least four days of data.Dietary intake was assessed using the Australian Eating Survey (AES). AES is a 120-item semi-quantitative Food Frequency Questionnaire (FFQ), used previously in Australian youth up to 16 years  and currNutrient intakes from the AES will be computed from the most current food composition database of Australian foods available, the Australian AusNut 1999 database (All Foods) Revision 17 and AusFoods (Brands) Revision 5  to generate individual mean daily macro-and micro-nutrient intakes. The AES includes questions about the total number of daily serves of fruit, vegetables, bread, dairy products, eggs, fat spreads, sweetened beverages and snack foods, as well as asking the type of bread, dairy products and fat spreads used. Twelve questions relate to food-related behaviours, including items on frequency of take-away food consumption and eating while watching television.Portion size was assessed using portion size photographs from the Dietary Questionnaire for Epidemiological Studies Version 2 (DQES v2), FFQ from the Cancer Council Victoria . These pAlcohol consumption was measured using an adaptation of the Australian Government Department of Veteran Affairs, Alcohol Use Disorders Identification Test (AUDIT) 2009 . This inPhysical activity and nutrition beliefs were assessed using a number of validated instruments: physical activity self efficacy , physicaSedentary behaviours were assessed using an adaptation of the Sitting Questionnaire, which has been shown to be both a valid and reliable measure of sitting time in various domains ,52.Quality of Life and general health was assessed using the UK short form 12 (SF-12) questionnaire ,54.Daytime Sleepiness was assessed using the Epworth sleepiness scale which is a valid measure of general daytime sleepiness .Sexual Function was assessed using the International Index of Erectile Function-5 (IIEF-5) questionnaire which has been shown to be a valid measure of erectile function .Adherence to self-monitoring  will be calculated from diaries for both treatment arms. In addition to this, men will hand in their SHED-IT support booklet at the 3- and 6-month time points, to be photocopied and posted back. We will also administer a detailed process questionnaire to examine men's perceptions of the SHED-IT program. This will include scales, individual items and open-ended questions that require men to describe the strengths and weaknesses of the program along with their suggestions for improvement. The process evaluation will cover issues such as the study feasibility, opinion of the allocated study group, use and appraisal of components of each intervention and their levels of overall satisfaction. We will also ask how much participants would be willing to pay for the offered intervention. The process evaluation will be administered at the 6-month time point.The sample size calculation is based on the primary outcome of weight loss at 6 months, which we have assumed will have a standard deviation of 5 kg ,57. ThirParticipants were randomised at an individual level by the trial statistician who will not have any contact with participants during the trial. Allocation was stratified by BMI category calculated at the baseline assessment  and the allocation sequence within strata was generated by a computer-based random number-producing algorithm in block lengths of six. Randomisation codes are stored in a restricted computer folder, which is not accessible by those assessing participants, those involved in group allocating participants or those participating in data entry for the study. Complete separation was achieved between the statistician who generated the randomisation sequence and those who concealed allocation from those involved in implementation of assignments.Study information for the three different groups was pre-packed into identical black plastic opaque envelopes and consecutively numbered within the three BMI categories and ordered according to the randomisation schedule. The packing and sequencing of these envelopes was completed by a research assistant who was not involved in enrolment, assessment or allocation of participants. Study participants completed all baseline assessments before proceeding to a separate room to meet with a research assistant who was not involved with the baseline assessments. The allocation sequence was concealed during this process. Participants' BMI category was calculated from the baseline measurements and the participant was allocated the next available number in that BMI category before being provided with their information pack. At this point the envelope was opened by the research assistant and details of the particular information pack were provided to the participant using a standardised protocol.Randomisation was undertaken by the trial statistician and measures will be taken by trained staff at all times points. In order to ensure accurate and consistent measurements, the study weight scale was professionally calibrated and the height scale checked and recalibrated daily before measurements commenced. All assessments were completed by staff blinded to treatment allocation. When men are contacted (via phone and email) to book in for follow-up assessments they will be asked not to inform data collection personnel of their group allocation. Data will be entered by research assistants blind to group allocation and a program of plausibility checks will be used to identify unrealistic values. The primary outcome measure (weight) will be double entered to ensure accuracy and a random 20% sample of all other measures will also be double entered.t tests for continuous variables and chi-squared (\u03c72) tests for categorical variables. The significance level for the comparison of baseline characteristics will be set at 0.05.Analyses will be performed using Stata Version 11 or later. All variables will be checked for plausibility and missing values. Data will be presented as mean (sd) for continuous variables and counts (percentages) for categorical variables. Differences between groups at randomisation and characteristics of completers versus dropouts will be tested using independent Resources vs. Control; Online vs. Control; and Resources vs. Online). The independent variables in the model will include a variable for treatment group, time  and the group-by-time interaction. The model will also include a term for the stratifying variable of BMI group at baseline. The coefficient and p-value for the group-by-6 month interaction term will be used to determine the efficacy of the interventions. Similar models will be used to examine differences in change in other outcome measures.A series of Generalised Linear Mixed Models (GLMMs) with a random intercept for individual will be used to test for differences between treatment groups in the mean level of weight after treatment. Separate models will be fit for each of the pair-wise comparisons  and of interest will be the 3 way interaction of treatment group by time by SES. We will also examine a range of secondary outcomes to support the primary outcome . Additional exploratory models will be fitted to examine if the men who have the greatest reduction in weight are also those who have the greatest improvements in the secondary outcomes.Statistical significance of the primary efficacy analysis (3 pair-wise comparisons) will be based on Hochberg's multiple testing procedure with the family wise error rate held at 5%. All secondary hypothesis tests will be performed using a 2-sided 5% significance level. In addition, linear regression and GLMMs will be used to describe relationships among the various dependent and independent variables.Online and Resources component. Men who complied well with the assigned treatment, defined as completion of requested daily eating and exercise diaries (n >40) over the 3-month period and weekly check-ins (n >10). Results of the per-protocol group will be compared with non-compliers in each group i.e. those who did not meet the above adherence recommendations.A per protocol analysis will also be conducted and include men who complied with treatment from the The aim of this study is to evaluate the efficacy of two 'low dose' weight loss programs developed specifically for men that could be widely and inexpensively implemented throughout Australia. We will determine whether these innovative approaches to obesity treatment will result in greater initial weight loss and improvements in cardiovascular risk factors compared to a Control group in a community sample of overweight men. There is an urgent need to develop and evaluate novel approaches to weight loss that attract and engage large numbers of men. We will also determine whether web-based support is more effective than resources alone. This study is designed to address the gap in service provision of community-based programs for overweight and obese men. There is limited evidence to guide the design of effective obesity treatment programs for overweight men that would be sustainable in most health care settings that do not require multiple visits to treatment centres.Our trial targets a national health priority in Australia and focuses on a high-risk under studied population. To successfully combat the obesity epidemic, clinicians and health care systems require feasible, effective and evidence-based treatment options that can be provided to large numbers of men. This randomised controlled trial will test alternative, evidence-based and theoretically driven, easily disseminated strategies specifically for weight loss in men. The interventions are all designed so they could serve as prototypes for rapid translation of research findings into widely available practical applications and widespread implementation in both the public health and medical care sectors. If successful, this project will reduce the negative health, economic and social consequences of obesity through clinically meaningful risk reduction in large numbers of overweight men.The authors declare that they have no competing interests.The study chief investigators PJM, RC, CEC, PM, RCP and Associate Investigator JMW were responsible for identifying the research question, design of the study, obtaining ethics approval, the acquisition of funding and overseeing study implementation. Associate Investigator TB and research assistants NB, MDY, EJA and KLS have contributed to development of intervention materials, recruiting participants and/or study implementation. All authors were responsible for the drafting of this manuscript and have read and approved the final version.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2458/10/701/prepub"]}
{"representative": "A 36-year-old man presented with headache and right upper and lower limb weakness for 10 days. MRI revealed absence of the odontoid process of the C2 vertebral body, with resultant atlantoaxial dislocation along with myelomalacic changes involving the cervicomedullary junction. Developmental anomalies of the odontoid are uncommon. The clinical importance lies in their potential to cause serious neurological complications due to atlantoaxial instability.We report a case of congenital absence of the dens, with resultant atlantoaxial dislocation and partial fusion of the C2 and C3 vertebrae.A 36-year-old man presented with a history of minor trauma to the head following a sudden jerk while traveling in a bus. He complained of headache and right upper and lower limb weakness. On examination, power in the right upper and lower limbs was 4/5. The right plantar reflex was extensor. No sensory deficit or bladder/bowel involvement was seen.MRI of the brain and the cervical spine was performed, which revealed absence of the odontoid process of the C2 vertebra , with reCongenital anomalies involving the craniovertebral junction are clinically important because of their potential for producing serious neurological deficits. The clinical features are chiefly because of the associated atlantoaxial dislocation and include persistent neck pain, headache, and transient/permanent paresis. Often, pCongenital anomalies involving the odontoid process are rare. They can be classified into os odontoideum, ossiculum terminale, aplasia-hypoplasia, and duplThe development of the axis is complex . Four osIn our case, the dens itself, as well as the part of the dens assimilated by the body of C2, was absent , the latAnomalies of the odontoid can usually be diagnosed on a standard series of radiographs, plus flexion and extension lateral films. With the increasing importance of CT scan and MRI in the study of the craniovertebral junction, a detailed evaluation of such congenital anomalies is now possible, as demonstrated in our case.The first case of odontoid hypoplasia was reported by Roberts in 1933. Since th", "texts": ["A 36-year-old man presented with headache and right upper and lower limb weakness for 10 days. MRI revealed absence of the odontoid process of the C2 vertebral body, with resultant atlantoaxial dislocation along with myelomalacic changes involving the cervicomedullary junction. Developmental anomalies of the odontoid are uncommon. The clinical importance lies in their potential to cause serious neurological complications due to atlantoaxial instability.We report a case of congenital absence of the dens, with resultant atlantoaxial dislocation and partial fusion of the C2 and C3 vertebrae.A 36-year-old man presented with a history of minor trauma to the head following a sudden jerk while traveling in a bus. He complained of headache and right upper and lower limb weakness. On examination, power in the right upper and lower limbs was 4/5. The right plantar reflex was extensor. No sensory deficit or bladder/bowel involvement was seen.MRI of the brain and the cervical spine was performed, which revealed absence of the odontoid process of the C2 vertebra , with reCongenital anomalies involving the craniovertebral junction are clinically important because of their potential for producing serious neurological deficits. The clinical features are chiefly because of the associated atlantoaxial dislocation and include persistent neck pain, headache, and transient/permanent paresis. Often, pCongenital anomalies involving the odontoid process are rare. They can be classified into os odontoideum, ossiculum terminale, aplasia-hypoplasia, and duplThe development of the axis is complex . Four osIn our case, the dens itself, as well as the part of the dens assimilated by the body of C2, was absent , the latAnomalies of the odontoid can usually be diagnosed on a standard series of radiographs, plus flexion and extension lateral films. With the increasing importance of CT scan and MRI in the study of the craniovertebral junction, a detailed evaluation of such congenital anomalies is now possible, as demonstrated in our case.The first case of odontoid hypoplasia was reported by Roberts in 1933. Since th"]}
{"representative": "Henipavirus, are zoonotic paramyxoviruses that have been associated with sporadic outbreaks of severe disease and mortality in humans since their emergence in the late 1990s. Similar to other paramyxoviruses, their ability to evade the host interferon (IFN) response is conferred by the P gene. The henipavirus P gene encodes four proteins; the P, V, W and C proteins, which have all been described to inhibit the antiviral response. Further studies have revealed that these proteins have overlapping but unique properties which enable the virus to block multiple signaling pathways in the IFN response. The best characterized of these is the JAK-STAT signaling pathway which is targeted by the P, V and W proteins via an interaction with the transcription factor STAT1. In addition the V and W proteins can both limit virus-induced induction of IFN but they appear to do this via distinct mechanisms that rely on unique sequences in their C-terminal domains. The ability to generate recombinant Nipah viruses now gives us the opportunity to determine the precise role for each of these proteins and address their contribution to pathogenicity. Additionally, the question of whether these multiple anti-IFN strategies are all active in the different mammalian hosts for henipaviruses, particularly the fruit bat reservoir, warrants further exploration.Hendra and Nipah virus, which constitute the genus  HeV wasus (NiV) . Humans us (NiV) . In humaus (NiV) . HeV andaviruses ,6. In Baaviruses . In addi2.2.1.Paramyxovirinae subfamily, extend the coding capacity of their genome via an mRNA editing mechanism that gives rise to multiple proteins from the P gene. During transcription of the P gene the polymerase stutters at a run of A and G residues referred to as the editing site and this results in the addition of non-templated G residues into the nascent mRNA. An unedited henipavirus P mRNA encodes the phosphoprotein (P), which participates in viral RNA synthesis as a cofactor for the polymerase. The insertion of one extra G residue shifts the frame and this mRNA encodes the V protein  and NiV P (Ser-240 and Ser-472) . It is n2.3.The fourth protein encoded by the henipavirus P gene is the C protein, which is expressed from an alternate ORF present in P, V and W transcripts. This 18 kDa protein localizes to the cytoplasm in a punctate pattern and it can be detected at low levels in NiV virions . Interes3.Cellular detection of virus infection is the trigger for initiating synthesis of IFN-\u03b2, and the molecules described to serve as cytoplasmic sensors for RNA viruses are RIG-I and mda-5 ,24. The 3.1.Paramyxovirus V proteins limit the synthesis of type I IFN via a highly conserved mechanism . A studyThe V proteins are notably unable to interact with or inhibit signaling from the related RNA helicase, RIG-I . Due to 3.2.Like the V protein, the W protein of NiV can also prevent activation of the IFN-\u03b2 promoter that is triggered by virus or intracellular dsRNA . As W ha4.Both type I (\u03b1/\u03b2) and type II (\u03b3) interferons (IFN) mediate their effects on cells by binding to receptors on the cell surface and activating the JAK-STAT signaling pathway . STAT S. The act4.1.In the presence of either NiV P, V or W proteins, there are reduced levels of tyrosine 701 phosphorylated STAT1 in IFN-\u03b1/\u03b2-treated cells ,18. ThisIn an unstimulated cell STAT1 shuttles between the cytoplasm and nucleus but upon IFN treatment, the phosphorylated and dimerized form translocates to the nucleus. In cells that are expressing P and V proteins, STAT1 is retained exclusively in the cytoplasm in its inactive, non-phosphorylated form even in the presence of IFN-\u03b1/\u03b2 or IFN-\u03b3 ,16,18. T4.2.As suggested by the strong co-localization data, the P, V and W proteins can all interact with STAT1 ,15\u201318. Tet al. [The STAT1 binding domain lies within the N-terminal portion of P, V and W ,15,17. Fet al.  examinedet al. . Mutatioet al. . Intereset al. . For botet al. .KO and CKO/G121E viruses display identical growth properties in both 293T and Vero cells, although interestingly both are attenuated relative to the wild-type NiV. Crucially, infection with the CKO/G121E virus induces STAT1 phosphorylation in response to IFN-\u03b2 whereas WT and CKO viruses do not [KO/G121E infected cells in response to IFN. In contrast the inactive form of STAT1 remains sequestered in the nuclei of NiV WT and CKO infected cells. As mentioned earlier, these data suggest that the nuclear W protein is functioning as the main obstacle to IFN signaling and that this is abolished by the G121E mutation, which eliminates the STAT1 interaction. The finding that the recombinant NiV lacking STAT1-binding has identical growth properties to its CKO parent virus, even in 293T cells , indicates that the lack of STAT1 inhibition is not detrimental to the virus. This suggests that additional anti-IFN mechanisms encoded by NiV are probably still intact. These could be either V-mediated inhibition of mda-5, W-mediated inhibition of IRF3 activity in the nucleus, or both acting in concert.In order to verify the importance of the residues conferring STAT1-binding within the context of the whole virus, it was necessary to determine whether they were also required for the polymerase co-factor function of the P protein. Using a NiV mini-genome assay to assess polymerase function, it was shown that the critical region for RNA synthesis lies within amino acids 81\u2013113 of the P protein and that substitutions that affect STAT1 binding do not interfere with polymerase activity ,21. Thiss do not . Also, net al. [To date, only the V protein has been reported to interact with STAT2 ,18,36. Tet al.  also demCurrently, there is limited information regarding the region of STAT1 that interacts with the NiV proteins. The domain structure of STAT1 can be broadly divided into an N-terminal domain, a coiled-coiled region, a DNA-binding domain, a linker domain, an SH2 domain and a transactivation domain . Using a5.KO virus which has attenuated growth properties relative to the wild-type virus [Of all the henipavirus P gene products, we know the least about the C protein. Plasmid-based expression of the NiV C protein has been shown to prevent the induction of a robust antiviral response  but the pe virus . The facpe virus .6.In conclusion, through their unique coding strategy, henipaviruses produce multiple proteins that antagonize the antiviral response at multiple levels. While the shared N-terminal domains of the P, V and W proteins direct inhibition of STAT signaling, the C-terminal domains of the V and W proteins confer unique properties on these proteins that extend their antagonist function. For V this involves mda-5-binding and for W this involves nuclear localization and the ability to block a late stage of the IFN induction pathway. The question of whether all these mechanisms are active in an infected cell is something that still needs to be explored. Unfortunately the need for biosafety level 4 conditions has limited this work but the description of a reverse genetics system for NiV opens the door to addressing the contribution of each protein and/or mechanism. Another factor to consider is that the presence of multiple anti-IFN mechanisms may relate to the zoonotic nature of these viruses. Even though it has already been shown that the NiV V protein can prevent IFN signaling in cells from multiple species , some of", "texts": ["Henipavirus, are zoonotic paramyxoviruses that have been associated with sporadic outbreaks of severe disease and mortality in humans since their emergence in the late 1990s. Similar to other paramyxoviruses, their ability to evade the host interferon (IFN) response is conferred by the P gene. The henipavirus P gene encodes four proteins; the P, V, W and C proteins, which have all been described to inhibit the antiviral response. Further studies have revealed that these proteins have overlapping but unique properties which enable the virus to block multiple signaling pathways in the IFN response. The best characterized of these is the JAK-STAT signaling pathway which is targeted by the P, V and W proteins via an interaction with the transcription factor STAT1. In addition the V and W proteins can both limit virus-induced induction of IFN but they appear to do this via distinct mechanisms that rely on unique sequences in their C-terminal domains. The ability to generate recombinant Nipah viruses now gives us the opportunity to determine the precise role for each of these proteins and address their contribution to pathogenicity. Additionally, the question of whether these multiple anti-IFN strategies are all active in the different mammalian hosts for henipaviruses, particularly the fruit bat reservoir, warrants further exploration.Hendra and Nipah virus, which constitute the genus  HeV wasus (NiV) . Humans us (NiV) . In humaus (NiV) . HeV andaviruses ,6. In Baaviruses . In addi2.2.1.Paramyxovirinae subfamily, extend the coding capacity of their genome via an mRNA editing mechanism that gives rise to multiple proteins from the P gene. During transcription of the P gene the polymerase stutters at a run of A and G residues referred to as the editing site and this results in the addition of non-templated G residues into the nascent mRNA. An unedited henipavirus P mRNA encodes the phosphoprotein (P), which participates in viral RNA synthesis as a cofactor for the polymerase. The insertion of one extra G residue shifts the frame and this mRNA encodes the V protein  and NiV P (Ser-240 and Ser-472) . It is n2.3.The fourth protein encoded by the henipavirus P gene is the C protein, which is expressed from an alternate ORF present in P, V and W transcripts. This 18 kDa protein localizes to the cytoplasm in a punctate pattern and it can be detected at low levels in NiV virions . Interes3.Cellular detection of virus infection is the trigger for initiating synthesis of IFN-\u03b2, and the molecules described to serve as cytoplasmic sensors for RNA viruses are RIG-I and mda-5 ,24. The 3.1.Paramyxovirus V proteins limit the synthesis of type I IFN via a highly conserved mechanism . A studyThe V proteins are notably unable to interact with or inhibit signaling from the related RNA helicase, RIG-I . Due to 3.2.Like the V protein, the W protein of NiV can also prevent activation of the IFN-\u03b2 promoter that is triggered by virus or intracellular dsRNA . As W ha4.Both type I (\u03b1/\u03b2) and type II (\u03b3) interferons (IFN) mediate their effects on cells by binding to receptors on the cell surface and activating the JAK-STAT signaling pathway . STAT S. The act4.1.In the presence of either NiV P, V or W proteins, there are reduced levels of tyrosine 701 phosphorylated STAT1 in IFN-\u03b1/\u03b2-treated cells ,18. ThisIn an unstimulated cell STAT1 shuttles between the cytoplasm and nucleus but upon IFN treatment, the phosphorylated and dimerized form translocates to the nucleus. In cells that are expressing P and V proteins, STAT1 is retained exclusively in the cytoplasm in its inactive, non-phosphorylated form even in the presence of IFN-\u03b1/\u03b2 or IFN-\u03b3 ,16,18. T4.2.As suggested by the strong co-localization data, the P, V and W proteins can all interact with STAT1 ,15\u201318. Tet al. [The STAT1 binding domain lies within the N-terminal portion of P, V and W ,15,17. Fet al.  examinedet al. . Mutatioet al. . Intereset al. . For botet al. .KO and CKO/G121E viruses display identical growth properties in both 293T and Vero cells, although interestingly both are attenuated relative to the wild-type NiV. Crucially, infection with the CKO/G121E virus induces STAT1 phosphorylation in response to IFN-\u03b2 whereas WT and CKO viruses do not [KO/G121E infected cells in response to IFN. In contrast the inactive form of STAT1 remains sequestered in the nuclei of NiV WT and CKO infected cells. As mentioned earlier, these data suggest that the nuclear W protein is functioning as the main obstacle to IFN signaling and that this is abolished by the G121E mutation, which eliminates the STAT1 interaction. The finding that the recombinant NiV lacking STAT1-binding has identical growth properties to its CKO parent virus, even in 293T cells , indicates that the lack of STAT1 inhibition is not detrimental to the virus. This suggests that additional anti-IFN mechanisms encoded by NiV are probably still intact. These could be either V-mediated inhibition of mda-5, W-mediated inhibition of IRF3 activity in the nucleus, or both acting in concert.In order to verify the importance of the residues conferring STAT1-binding within the context of the whole virus, it was necessary to determine whether they were also required for the polymerase co-factor function of the P protein. Using a NiV mini-genome assay to assess polymerase function, it was shown that the critical region for RNA synthesis lies within amino acids 81\u2013113 of the P protein and that substitutions that affect STAT1 binding do not interfere with polymerase activity ,21. Thiss do not . Also, net al. [To date, only the V protein has been reported to interact with STAT2 ,18,36. Tet al.  also demCurrently, there is limited information regarding the region of STAT1 that interacts with the NiV proteins. The domain structure of STAT1 can be broadly divided into an N-terminal domain, a coiled-coiled region, a DNA-binding domain, a linker domain, an SH2 domain and a transactivation domain . Using a5.KO virus which has attenuated growth properties relative to the wild-type virus [Of all the henipavirus P gene products, we know the least about the C protein. Plasmid-based expression of the NiV C protein has been shown to prevent the induction of a robust antiviral response  but the pe virus . The facpe virus .6.In conclusion, through their unique coding strategy, henipaviruses produce multiple proteins that antagonize the antiviral response at multiple levels. While the shared N-terminal domains of the P, V and W proteins direct inhibition of STAT signaling, the C-terminal domains of the V and W proteins confer unique properties on these proteins that extend their antagonist function. For V this involves mda-5-binding and for W this involves nuclear localization and the ability to block a late stage of the IFN induction pathway. The question of whether all these mechanisms are active in an infected cell is something that still needs to be explored. Unfortunately the need for biosafety level 4 conditions has limited this work but the description of a reverse genetics system for NiV opens the door to addressing the contribution of each protein and/or mechanism. Another factor to consider is that the presence of multiple anti-IFN mechanisms may relate to the zoonotic nature of these viruses. Even though it has already been shown that the NiV V protein can prevent IFN signaling in cells from multiple species , some of"]}
{"representative": "Intimate partner violence (IPV) is a significant public health problem. There is a lack of data on IPV risk factors from longitudinal studies and from low and middle income countries. Identifying risk factors is needed to inform the design of appropriate IPV interventions.Data were from the Rakai Community Cohort Study annual surveys between 2000 and 2009. Female participants who had at least one sexual partner during this period and had data on IPV over the study period were included in analyses (N\u2009=\u200915081). Factors from childhood and early adulthood as well as contemporary factors were considered in separate models. Logistic regression was used to assess early risk factors for IPV during the study period. Longitudinal data analysis was used to assess contemporary risk factors in the past year for IPV in the current year, using a population-averaged multivariable logistic regression model.Risk factors for IPV from childhood and early adulthood included sexual abuse in childhood or adolescence, earlier age at first sex, lower levels of education, and forced first sex. Contemporary risk factors included younger age, being married, relationships of shorter duration, having a partner who is the same age or younger, alcohol use before sex by women and by their partners, and thinking that violence is acceptable. HIV infection and pregnancy were not associated with an increased odds of IPV.Using longitudinal data, this study identified a number of risk factors for IPV. These findings are useful for the development of prevention strategies to prevent and mitigate IPV in women. Violence against women is a serious and common human rights and public health problem, which causes significant morbidity and mortality worldwide . IntimatKnowledge of context-specific risk factors for IPV is important to be able to appropriately focus prevention efforts. A recent World Health Organization (WHO) review noted the lack of data on IPV risk factors from longitudinal studies and from low and middle income countries . This bri.e. communities which lack legal sanctions and where women lack access to shelters and family support, and in which there is less moral pressure for neighbours to intervene if a woman is beaten). Societal level factors are divorce regulations, a lack of legislation on IPV within marriage, protective marriage laws, and traditional gender and social norms [The WHO review identified risk factors for IPV and classified them into the four levels of an ecological framework: individual, relationship, community and societal levels factors . Individal norms .i.e. not legally or formally married) compared to being married, being married compared to having a boyfriend or other casual partner, having a partner who consumed alcohol before sex, and a woman perceiving her partner to have a higher risk of HIV infection were risk factors for IPV [Recent cross-sectional studies of women in sub-Saharan Africa have identified some of these same risk factors for IPV -6, as we for IPV ,8.In this study, we aimed to identify risk factors for IPV in women of reproductive age in Rakai District, Uganda, using longitudinal data from seven survey rounds of the Rakai Community Cohort Study between 2000 and 2009. We assessed characteristics shown to be risk factors in other settings -6.Since 1994, the Rakai Health Sciences Program has followed an open cohort of about 12,000 participants aged 15 to 49\u00a0years in 50 communities in the Rakai district of southwestern Uganda. The cohort has been described in detail elsewhere . In brieWomen who participated in the study between 2000 and 2009 were included in analyses if they reported at least one sexual partner during the study period and if they had provided any data on whether they experienced IPV during the study period.Intimate partner violence (IPV) was defined as any physical, sexual, or verbal violence by a partner in an intimate relationship. Questions on IPV were modified from the Revised Conflict Tactics Scales (CTS2), and, in some analyses, type of IPV was classified as minor or severe as per the CTS2 ,12. Minoi.e. in childhood or in early adulthood) and contemporary factors defined as variables that may affect women in their current lives. These two groups of variables were analysed separately.Potential risk factors for IPV were determined based on the literature and on which data were collected for the RCCS between 2000 and 2009. Since characteristics and experiences in early life may cause some of the characteristics and experiences in adulthood, and specifically, risk factors for IPV in adulthood may be on the causal pathway from early factors to IPV , risk vai.e. from the first round of participation during the period under study.Early factors included sexual abuse in childhood or adolescence , age at Contemporary factors included demographic variables such as age -21,23-25For participants who reported multiple partners in the past year, data about the partner with whom the participant reported having had sex most recently was used for the variables type of relationship with partner, alcohol use by partner, length of sexual partnership, and difference in age with partner; it was not possible to determine which specific partner (if any) had perpetrated violence.The prevalence of IPV and of potential IPV risk factors was assessed. To identify early factors, logistic regression was used to estimate the bivariate and multivariable odds ratios (OR) and 95% confidence intervals (95% CI) associated with violence during the period of study participation. For contemporary factors, population-averaged logistic regression models were used to look at bivariate and multivariable associations , which aa priori as being of greater importance on the basis of known associations with violence, including sexual abuse in childhood or adolescence, coerced first sex, and education for early factors, and age, marital status, pregnancy status, difference in age with partner, use of alcohol, number of partners in past year, and attitudes toward violence for contemporary factors [i.e. age at first sex for early factors and beginning with relationship type for contemporary factors, until the first variable was encountered with a p value of p\u2009<\u20090.1, either by Wald test or by likelihood ratio test, depending on whether the variable was continuous, binary, or categorical.For each of early factors and contemporary factors, since there were multiple predictors of interest and to minimize the risk of Type I error of conventional backward selection models, an Allen-Cady modified backward selection procedure was used for the multivariable models . Candida factors ,27,32. ASeparate models were run to look at the associations between contemporary factors and risk of violence in the same year, in consideration of the fact that certain associations, such as the temporal association between pregnancy and violence, might not be adequately captured when looking at exposure and outcome data from sequential years. Analyses were done using Stata 12.During the period under study, the Rakai Community Cohort Study was approved by institutional review boards at the Scientific and Ethics Committee of the Uganda Virus Research Institute, the Uganda National Council of Science and Technology, Columbia University, Johns Hopkins University, Johns Hopkins Bloomberg School of Public Health, and the Western. Ethics approval was obtained for this analysis from the University of Toronto.Of the 20584 women who participated in the study over this period, 15081 (73.3%) were included in these analyses. One hundred twenty women were excluded because they were younger than 15 or older than 49 during the entire period under study, four women were excluded because they had a positive HIV test result and subsequent negative tests, 3228 women were excluded because they were not sexually active during the study period, and 2151 were excluded because they did not have any data on IPV during the study period.IPV was common in this population, as shown in Table\u00a0Most women (66%) who experienced any violence experienced more than one form of violence concurrently. In the most recent survey round of participation for the 4367 women who reported any IPV, 1064 women (24.4%) reported experiencing verbal violence only, 322 (7.4%) reported sexual violence only, and 94 (2.2%) reported physical violence only. Six hundred eighty-three women (15.6%) experienced verbal and physical violence only, 218 (5.0%) women reported verbal and sexual violence only, and 443 (10.1%) reported physical and sexual violence only, while 1289 women (29.5%) reported all three forms of violence.Women commonly experienced violence early in life, with 31.3% of 1784 women reporting sexual abuse in childhood or adolescence and 17.5% of 11607 reporting coerced first sex, as shown in Table\u00a0In bivariate analyses, as shown in Table\u00a0The frequency of characteristics and behaviours was examined, as shown in Table\u00a0Table\u00a0Multivariable models of the association between contemporary factors in the current year and IPV in the current year revealed qualitatively similar associations (data not shown). Of note, pregnancy was not a risk factor for violence in the same year, and in fact was associated with a lower risk of IPV with an odds ratio of 0.91 .As found in diverse international studies, IPV is prevalent in this population and most women who experienced IPV reported experiencing more than one form of violence concurrently. Several of the risk factors identified in this longitudinal study are consistent with existing evidence , includie.g. which types of IPV were measured, may affect estimates of association. In this study, data on physical, verbal, and sexual IPV were included, however, there were no data collected on controlling behaviours, which could affect the magnitude of association identified if controlling behaviours were associated with pregnancy independently of other forms of IPV. Finally, the finding of a lack of association could reflect effect modification on the basis of geographical or cultural contexts, i.e. that the association between pregnancy and IPV may only exist in certain contexts.In contrast with much of the literature on risk factors for IPV , but coni.e. that prevalent and incident cases of HIV and IPV were included in the exposure and outcome, respectively, the types of IPV included as noted above, or the period in which the exposure and outcome were measured (i.e. one year), which may not reflect the relevant period of exposure for this association; the inclusion and control of relevant confounders; or that HIV leading to IPV is not a significant pathway in this population.Another notable finding of this study is that HIV infection was not associated with IPV in the subsequent year, with an unadjusted odds ratio of 1.02  and an adjusted odds ratio of 1.03 . In other population-based studies from East Africa, one cross-sectional study  and one The strengths of this study are its large size, high participation rates, prospective design, the inclusion of several important variables as potential predictors, the separation of early and contemporary factors in analyses, and the focus on a low income country. There are several limitations to this study. Some risk factors which may be relevant were not included in the analyses because data were not available, such as number of children, income level, and the gap in income and education between partners, which may result in residual confounding of the associations between examined variables and IPV. Some variables may not specifically identify risky behaviour, for example the use of any alcohol before sex as opposed to heavy alcohol use or more general problematic alcohol consumption, which may dilute any association and bias the estimate of the effects of problematic alcohol use toward the null. The questions on IPV were modified from the CTS2, however, this version of the scale has not been validated in this population, which could contribute to measurement error. Also, as noted earlier, no data were collected on controlling behaviours as part of the definition of IPV, which could lead to an underestimate of associations. For contemporary factors, the exposure period was assumed to be the year prior to IPV, and for early factors, only IPV during the period under study was examined. In fact, the relevant exposure period for contemporary factors may be longer or shorter than a year, and for both early and contemporary factors, may take place closer to or further from any IPV incidents; these temporal relationships have not yet been well defined. Since we did not assess the role of early and contemporary factors together in one model, we are unable to determine whether contemporary factors are on the causal pathway between early factors and IPV, as hypothesized, or, in the event that contemporary factors are not in the causal pathway between early factors and IPV, whether early or contemporary factors are more strongly associated with experiencing IPV. Finally, it was not possible to discern whether data on violence were relevant to a specific partner for women who had more than one partner, however, this would not likely affect the validity of the results since consistently fewer than seven percent of women had more than one sexual partner in each survey round.i.e. sexual abuse in childhood or adolescence, lower levels of education, forced first sex, younger age, alcohol use by women and their partners, being in a relationship of shorter duration and thinking that violence is acceptable. The data also suggest that several hypothesized risk factors may not be associated with IPV, i.e. pregnancy and HIV positivity. Finally, the analysis also identifies novel risk factors for IPV in this setting, i.e. younger age at first sex, coerced first sex, and having a partner the same age or younger. These findings are likely generalizable to other rural areas in sub-Saharan Africa and potentially elsewhere, and have direct implications for public health action in terms of the primary and secondary prevention of IPV.In summary, this analysis confirms that certain established risk factors from other settings are associated with IPV in this setting, There are diverse approaches to addressing violence against women , and theThe authors declare that they have no competing interests.FK developed the research question and protocol, conducted analyses, and drafted the manuscript. LC, SB, and PO contributed to the analysis and interpretation of data. RG and JK were involved in the conception and design of the study, acquisition of data, and analysis and interpretation of data. DS, FN, GK, and MW were involved in conception and design of the study, and acquisition of data. All authors revised the manuscript and approved the final draft.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2458/13/566/prepub", "texts": ["Intimate partner violence (IPV) is a significant public health problem. There is a lack of data on IPV risk factors from longitudinal studies and from low and middle income countries. Identifying risk factors is needed to inform the design of appropriate IPV interventions.Data were from the Rakai Community Cohort Study annual surveys between 2000 and 2009. Female participants who had at least one sexual partner during this period and had data on IPV over the study period were included in analyses (N\u2009=\u200915081). Factors from childhood and early adulthood as well as contemporary factors were considered in separate models. Logistic regression was used to assess early risk factors for IPV during the study period. Longitudinal data analysis was used to assess contemporary risk factors in the past year for IPV in the current year, using a population-averaged multivariable logistic regression model.Risk factors for IPV from childhood and early adulthood included sexual abuse in childhood or adolescence, earlier age at first sex, lower levels of education, and forced first sex. Contemporary risk factors included younger age, being married, relationships of shorter duration, having a partner who is the same age or younger, alcohol use before sex by women and by their partners, and thinking that violence is acceptable. HIV infection and pregnancy were not associated with an increased odds of IPV.Using longitudinal data, this study identified a number of risk factors for IPV. These findings are useful for the development of prevention strategies to prevent and mitigate IPV in women. Violence against women is a serious and common human rights and public health problem, which causes significant morbidity and mortality worldwide . IntimatKnowledge of context-specific risk factors for IPV is important to be able to appropriately focus prevention efforts. A recent World Health Organization (WHO) review noted the lack of data on IPV risk factors from longitudinal studies and from low and middle income countries . This bri.e. communities which lack legal sanctions and where women lack access to shelters and family support, and in which there is less moral pressure for neighbours to intervene if a woman is beaten). Societal level factors are divorce regulations, a lack of legislation on IPV within marriage, protective marriage laws, and traditional gender and social norms [The WHO review identified risk factors for IPV and classified them into the four levels of an ecological framework: individual, relationship, community and societal levels factors . Individal norms .i.e. not legally or formally married) compared to being married, being married compared to having a boyfriend or other casual partner, having a partner who consumed alcohol before sex, and a woman perceiving her partner to have a higher risk of HIV infection were risk factors for IPV [Recent cross-sectional studies of women in sub-Saharan Africa have identified some of these same risk factors for IPV -6, as we for IPV ,8.In this study, we aimed to identify risk factors for IPV in women of reproductive age in Rakai District, Uganda, using longitudinal data from seven survey rounds of the Rakai Community Cohort Study between 2000 and 2009. We assessed characteristics shown to be risk factors in other settings -6.Since 1994, the Rakai Health Sciences Program has followed an open cohort of about 12,000 participants aged 15 to 49\u00a0years in 50 communities in the Rakai district of southwestern Uganda. The cohort has been described in detail elsewhere . In brieWomen who participated in the study between 2000 and 2009 were included in analyses if they reported at least one sexual partner during the study period and if they had provided any data on whether they experienced IPV during the study period.Intimate partner violence (IPV) was defined as any physical, sexual, or verbal violence by a partner in an intimate relationship. Questions on IPV were modified from the Revised Conflict Tactics Scales (CTS2), and, in some analyses, type of IPV was classified as minor or severe as per the CTS2 ,12. Minoi.e. in childhood or in early adulthood) and contemporary factors defined as variables that may affect women in their current lives. These two groups of variables were analysed separately.Potential risk factors for IPV were determined based on the literature and on which data were collected for the RCCS between 2000 and 2009. Since characteristics and experiences in early life may cause some of the characteristics and experiences in adulthood, and specifically, risk factors for IPV in adulthood may be on the causal pathway from early factors to IPV , risk vai.e. from the first round of participation during the period under study.Early factors included sexual abuse in childhood or adolescence , age at Contemporary factors included demographic variables such as age -21,23-25For participants who reported multiple partners in the past year, data about the partner with whom the participant reported having had sex most recently was used for the variables type of relationship with partner, alcohol use by partner, length of sexual partnership, and difference in age with partner; it was not possible to determine which specific partner (if any) had perpetrated violence.The prevalence of IPV and of potential IPV risk factors was assessed. To identify early factors, logistic regression was used to estimate the bivariate and multivariable odds ratios (OR) and 95% confidence intervals (95% CI) associated with violence during the period of study participation. For contemporary factors, population-averaged logistic regression models were used to look at bivariate and multivariable associations , which aa priori as being of greater importance on the basis of known associations with violence, including sexual abuse in childhood or adolescence, coerced first sex, and education for early factors, and age, marital status, pregnancy status, difference in age with partner, use of alcohol, number of partners in past year, and attitudes toward violence for contemporary factors [i.e. age at first sex for early factors and beginning with relationship type for contemporary factors, until the first variable was encountered with a p value of p\u2009<\u20090.1, either by Wald test or by likelihood ratio test, depending on whether the variable was continuous, binary, or categorical.For each of early factors and contemporary factors, since there were multiple predictors of interest and to minimize the risk of Type I error of conventional backward selection models, an Allen-Cady modified backward selection procedure was used for the multivariable models . Candida factors ,27,32. ASeparate models were run to look at the associations between contemporary factors and risk of violence in the same year, in consideration of the fact that certain associations, such as the temporal association between pregnancy and violence, might not be adequately captured when looking at exposure and outcome data from sequential years. Analyses were done using Stata 12.During the period under study, the Rakai Community Cohort Study was approved by institutional review boards at the Scientific and Ethics Committee of the Uganda Virus Research Institute, the Uganda National Council of Science and Technology, Columbia University, Johns Hopkins University, Johns Hopkins Bloomberg School of Public Health, and the Western. Ethics approval was obtained for this analysis from the University of Toronto.Of the 20584 women who participated in the study over this period, 15081 (73.3%) were included in these analyses. One hundred twenty women were excluded because they were younger than 15 or older than 49 during the entire period under study, four women were excluded because they had a positive HIV test result and subsequent negative tests, 3228 women were excluded because they were not sexually active during the study period, and 2151 were excluded because they did not have any data on IPV during the study period.IPV was common in this population, as shown in Table\u00a0Most women (66%) who experienced any violence experienced more than one form of violence concurrently. In the most recent survey round of participation for the 4367 women who reported any IPV, 1064 women (24.4%) reported experiencing verbal violence only, 322 (7.4%) reported sexual violence only, and 94 (2.2%) reported physical violence only. Six hundred eighty-three women (15.6%) experienced verbal and physical violence only, 218 (5.0%) women reported verbal and sexual violence only, and 443 (10.1%) reported physical and sexual violence only, while 1289 women (29.5%) reported all three forms of violence.Women commonly experienced violence early in life, with 31.3% of 1784 women reporting sexual abuse in childhood or adolescence and 17.5% of 11607 reporting coerced first sex, as shown in Table\u00a0In bivariate analyses, as shown in Table\u00a0The frequency of characteristics and behaviours was examined, as shown in Table\u00a0Table\u00a0Multivariable models of the association between contemporary factors in the current year and IPV in the current year revealed qualitatively similar associations (data not shown). Of note, pregnancy was not a risk factor for violence in the same year, and in fact was associated with a lower risk of IPV with an odds ratio of 0.91 .As found in diverse international studies, IPV is prevalent in this population and most women who experienced IPV reported experiencing more than one form of violence concurrently. Several of the risk factors identified in this longitudinal study are consistent with existing evidence , includie.g. which types of IPV were measured, may affect estimates of association. In this study, data on physical, verbal, and sexual IPV were included, however, there were no data collected on controlling behaviours, which could affect the magnitude of association identified if controlling behaviours were associated with pregnancy independently of other forms of IPV. Finally, the finding of a lack of association could reflect effect modification on the basis of geographical or cultural contexts, i.e. that the association between pregnancy and IPV may only exist in certain contexts.In contrast with much of the literature on risk factors for IPV , but coni.e. that prevalent and incident cases of HIV and IPV were included in the exposure and outcome, respectively, the types of IPV included as noted above, or the period in which the exposure and outcome were measured (i.e. one year), which may not reflect the relevant period of exposure for this association; the inclusion and control of relevant confounders; or that HIV leading to IPV is not a significant pathway in this population.Another notable finding of this study is that HIV infection was not associated with IPV in the subsequent year, with an unadjusted odds ratio of 1.02  and an adjusted odds ratio of 1.03 . In other population-based studies from East Africa, one cross-sectional study  and one The strengths of this study are its large size, high participation rates, prospective design, the inclusion of several important variables as potential predictors, the separation of early and contemporary factors in analyses, and the focus on a low income country. There are several limitations to this study. Some risk factors which may be relevant were not included in the analyses because data were not available, such as number of children, income level, and the gap in income and education between partners, which may result in residual confounding of the associations between examined variables and IPV. Some variables may not specifically identify risky behaviour, for example the use of any alcohol before sex as opposed to heavy alcohol use or more general problematic alcohol consumption, which may dilute any association and bias the estimate of the effects of problematic alcohol use toward the null. The questions on IPV were modified from the CTS2, however, this version of the scale has not been validated in this population, which could contribute to measurement error. Also, as noted earlier, no data were collected on controlling behaviours as part of the definition of IPV, which could lead to an underestimate of associations. For contemporary factors, the exposure period was assumed to be the year prior to IPV, and for early factors, only IPV during the period under study was examined. In fact, the relevant exposure period for contemporary factors may be longer or shorter than a year, and for both early and contemporary factors, may take place closer to or further from any IPV incidents; these temporal relationships have not yet been well defined. Since we did not assess the role of early and contemporary factors together in one model, we are unable to determine whether contemporary factors are on the causal pathway between early factors and IPV, as hypothesized, or, in the event that contemporary factors are not in the causal pathway between early factors and IPV, whether early or contemporary factors are more strongly associated with experiencing IPV. Finally, it was not possible to discern whether data on violence were relevant to a specific partner for women who had more than one partner, however, this would not likely affect the validity of the results since consistently fewer than seven percent of women had more than one sexual partner in each survey round.i.e. sexual abuse in childhood or adolescence, lower levels of education, forced first sex, younger age, alcohol use by women and their partners, being in a relationship of shorter duration and thinking that violence is acceptable. The data also suggest that several hypothesized risk factors may not be associated with IPV, i.e. pregnancy and HIV positivity. Finally, the analysis also identifies novel risk factors for IPV in this setting, i.e. younger age at first sex, coerced first sex, and having a partner the same age or younger. These findings are likely generalizable to other rural areas in sub-Saharan Africa and potentially elsewhere, and have direct implications for public health action in terms of the primary and secondary prevention of IPV.In summary, this analysis confirms that certain established risk factors from other settings are associated with IPV in this setting, There are diverse approaches to addressing violence against women , and theThe authors declare that they have no competing interests.FK developed the research question and protocol, conducted analyses, and drafted the manuscript. LC, SB, and PO contributed to the analysis and interpretation of data. RG and JK were involved in the conception and design of the study, acquisition of data, and analysis and interpretation of data. DS, FN, GK, and MW were involved in conception and design of the study, and acquisition of data. All authors revised the manuscript and approved the final draft.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2458/13/566/prepub"]}
{"representative": "About 50% of patients in substance abuse treatment with a partner perpetrated and/or experienced intimate partner violence in the past year. To date, there are no screeners to identify both perpetrators and victims of partner intimate violence in a substance abusing population. We developed a 4 item screening instrument for this purpose, the Jellinek Inventory for assessing Partner Violence (J-IPV). Important strengths of the J-IPV are that it takes only 2 minutes to administer and is easy to use and to score.To investigate the validity of the J-IPV, two independent studies were conducted including 98 and 99 participants, respectively. Aim of the second study was to cross-validate findings from the first study. Psychometric properties of the J-IPV were determined by calculating sensitivity, specificity, positive and negative predictive value, and positive and negative likelihood ratio\u2019s by comparing J-IPV outcomes to outcomes on the Revised Conflict Tactics Scales (\u2018gold standard\u2019). Also, receiver operator characteristics (ROC)-curves were determined to weight sensitivity and specificity as a result of different J-IPV cutoffs, and the area under the curve (AUC) was calculated.any as well as severe intimate partner violence. Results from the second study replicated findings from the first study.Results of the first study demonstrated that the J-IPV possesses good psychometric properties to detect perpetrators and victims of We recommend administering the J-IPV to patients entering substance abuse treatment. If perpetrators and victims of partner violence are identified, action can be taken to stop IPV perpetration and arrange help for victims, for example by offering perpetrators treatment or by providing safety planning or advocacy interventions to victims. Consequences of physical IPV can be severe for victims and may result in injuries, chronic pain, depression, posttraumatic stress disorder, suicidality, and substance use disorders ar e.g., .Because of the serious consequences of IPV and its high prevalence among patients in substance abuse treatment, it is important to assess IPV perpetration among these individuals. Ideally, IPV perpetrators should be identified at intake in order to prevent further assault of victims victimization of IPV in the past year; the latter two questions address perpetration of IPV in the past year  On the basis of the criteria described above we developed the 4 items counting Jellinek Inventory for assessing Partner Violence (J-IPV), a screener that takes only 2 minutes to administer, and is simple to use and score. The first two questions of the J-IPV address year see . The itell e.g., , it was To determine psychometric properties of the J-IPV for detecting 1) any IPV perpetration, 2) severe IPV perpetration, 3) any IPV victimization, and 4) severe IPV victimization, the following values were determined: 1) sensitivity , 2) specificity , 3) positive predictive value , and 4) negative predictive value  were computed. In addition, positive likelihood ratio  and negative likelihood ratio  were calculated as suggested, for example, by There are no universal criteria to determine the minimum standards of a screening instrument, since it depends on the situation whether greater value is attached to sensitivity or specificity The study was approved by the ethical committee of the University of Amsterdam (reference number 2010-kp-1350). Written informed consent was obtained from all participants.th 2011 and April 22nd 2011 in Amsterdam or between December 28th 2011 and October 17th 2012 in Hilversum. Patients were included if they 1) fulfilled DSM-IV-TR criteria for substance abuse or dependence (with the exclusion of nicotine dependence as the sole substance use disorder diagnosis), 2) had a partner for at least 3 months in the past year, 3) had sufficient knowledge of the Dutch language , and 4) were at least 18 years old. Patients were excluded in case of 1) severe withdrawal or intoxication symptoms during the intake, 2) severe mental illness , and 3) severe cognitive disorders, such as Korsakoff\u2019s syndrome or dementia.The two studies were conducted at two different locations of Jellinek, a large substance abuse treatment facility, in Amsterdam (study 1) and Hilversum (study 2), the Netherlands. Patients were included if they had an intake between February 28The J-IPV is a 4 item-screening device that was developed to assess IPV perpetration in patients entering substance abuse treatment. FK formulated the items of the J-IPV and EV, AS, and PE independently reviewed the items; the final items were based on consensus. The questions are administered as a structured interview and questions are answered with \u2018yes\u2019 or \u2018no\u2019. Two native English speakers translated the J-IPV from Dutch into English. Translations were compared with one another and led to the final English version of the J-IPV see .physical IPV, we only used item pairs assessing physical violence (2\u00d712 items). To make the transition to the physical violence items more gradual, firstly 3 items pairs addressing verbal violence were administered . Subsequently, the physical violence items of the CTS2 were administered in the same order in which they appear in the CTS2. The other CTS2 items were not used in this study. The physical violence items of the CTS2 were used to categorize participants as perpetrator and/or victim of any/severe physical IPV. Participants were rated as perpetrator of any IPV when answering \u2018yes\u2019 to at least one physical IPV perpetration item and were rated as victim of any IPV after at least one \u2018yes\u2019 to any of the physical IPV victimization items. Further, participants were classified as having perpetrated severe physical IPV or being victimized by severe physical IPV if at least one of the severe physical violence perpetration or victimization items was answered with \u201cyes\u201d. The adapted version of the CTS2 was administered as a structured interview, a method that was supported by The CTS2 The MATE During the intake, psychologists from the treatment staff who regularly conducted the intakes and were not involved in the factual studies administered the MATE. Subsequently, patients were informed about the study. If they agreed to participate, informed consent was obtained. Hereafter, the J-IPV and CTS2 were administered successively as structured interview. Since the aim of the study was to investigate whether the J-IPV predicted the outcome on the CTS2, we did not counterbalance administration of the J-IPV and CTS2. To help participants remember the 7-point rating scale of the CTS2, they were given a form with response categories written out. The first study was conducted at Jellinek Amsterdam; the second study at Jellinek Hilversum in order to cross-validate findings from the first study.Demographics of participants of the 2 studies were compared using chi-square tests for categorical variables ; an independent samples t-test for normally distributed continuous variables (age); and a Mann-Whitney test for nonnormally distributed continuous variables (relationship length). To determine psychometric properties of the J-IPV, sensitivity, specificity, PPV, NPV, LR+, LR\u2212, and AUC were calculated for the J-IPV compared to the CTS2 as \u2018gold standard\u2019  only both J-IPV perpetration items were used (items 3 and 4) and 3) the separate items addressing IPV perpetration (items 3 and 4) were used. Psychometric properties of the J-IPV to detect any/severe IPV victimization were determined when 1) all J-IPV items were used, 2) only both J-IPV victimization items were used (items 1 and 2) and 3) the separate items addressing IPV victimization (items 1 and 2) were used. After determining psychometric properties for these different options, the optimal cutoff or scoring method was selected to classify participants as 1) perpetrator of any IPV, 2) perpetrator of severe IPV, 3) victim of any IPV, and 4) victim of severe IPV. As mentioned in the introduction, we valued high sensitivity and NPV the most important psychometric properties the J-IPV should possess because it might be harmful to overlook perpetrators and victims of IPV. Therefore, the following steps were taken to decide on the optimal cutoff or scoring method. First, it was examined which cutoff or scoring method resulted in highest sensitivity and NPV. Then, it was observed whether this scoring method also yielded the highest AUC, and finally it was examined whether specificity and PPV were still acceptable.Prior to the start of this study, the J-IPV had been used in clinical practice for 20 months. Clinical observations taught that some patients who had committed physical IPV but saw themselves primarily as victim (and not perpetrator), did answer positively to one or both victimization items, but not to any of the perpetrator items. This demonstrates that people tend to underreport IPV perpetration e.g.,  but alsoA total of 115 participants met inclusion criteria. Seventeen participants (14.8%) were excluded: 7 participants (6.1%) refused participation, 5 (4.3%) suffered from severe mental illness, 4 (3.5%) dropped-out because of logistic reasons, and 1 (0.9%) suffered from a severe cognitive disorder see . The finOn the basis of the CTS2, participants were classified as 1) no perpetrator, no victim, 2) perpetrator only, 3) victim only, and 4) both perpetrator and victim of physical IPV see . About hA total of 158 participants met inclusion criteria. Fifty-nine participants (37.3%) were excluded: 8 participants (5.1%) refused participation, 11 (7.0%) suffered from severe mental problems, 4 (2.5%) suffered from a severe cognitive disorder; 2 (1.3%) were severely intoxicated, 3 (1.9%) dropped-out because the intaker was not yet trained in administering the J-IPV and CTS2, and 31 (19.6%) dropped-out because of logistic reasons see . The finIn addition, as in study 1, participants were classified as (non) perpetrator and/or victim of IPV see . Again, 2 (2)\u200a=\u200a6.21; p<.05). Standardized residuals indicated that more participants of study 1 had a non-European nationality than participants in study 2. In addition, participants of study 1 and 2 differed significantly form one another regarding relationship length (F (186)\u200a=\u200a4.52; p<.05); participants of study 2 had significantly longer relationships than participants of study 1. Participants of study 1 and 2 did not differ significantly regarding gender, age, living together, relationship at the time of the intake, children under 18, treatment intensity, and primary substance use disorder diagnosis. In addition, there were no differences between the 2 studies regarding prevalence rates of any/severe past year IPV perpetration/victimization. Also, there were no differences in rates of reciprocality of IPV  psychometric properties of both J-IPV perpetration items (items 3 and 4) were calculated, and 3), diagnostic efficiency was calculated for items 3 and 4, separately (see any of the J-IPV items) resulted in highest sensitivity (.80) and NPV (.85) (the indicators that were decided to be most important to the J-IPV). Also, the largest AUC (.80) was obtained when all 4 J-IPV items were used. In addition, specificity (.80) and PPV (.75) were still acceptable for this option, as well as LR+ (4.17), and an LR\u2212 (.24). For study 2, similar results were found   see . For illTo detect severe IPV perpetration, using a cutoff of 2 resulted in optimal psychometric properties in study 1  psychometric properties of both J-IPV victimization items (items 1 and 2) were calculated, and 3) diagnostic efficiency fore detecting IPV victimization was calculated for the separate victimization items (1 or 2). A cutoff of 1 resulted in the most favorable psychometric properties . Similar results were obtained in study 2 . ROC-curves are displayed in Psychometric properties for detecting any physical IPV victimization using CTS2 victimization items as \u2018gold standard\u2019 are displayed in severe physical IPV victimization were determined  and NPV . In other words, 80/84% of IPV perpetrators screened positive for IPV perpetration on the J-IPV; after screening negative, 85/82% of the participants had indeed not committed IPV. 2) To detect severe IPV perpetration, optimal results were found for a cutoff of 2, which resulted in sensitivity and NPV of 1.00 in both studies. 3) To detect any IPV victimization, we recommend using a cutoff of 1, which resulted in highest sensitivity (.83 and.80) and NPV (.87 and.86). It is noticeable that the same cutoff was suggested for detecting any IPV perpetration; this could be explained by the fact that in about 70% of the cases IPV was reciprocal .The aim of the present study was to validate and cross-validate the J-IPV by determining its sensitivity, NPV, AUC, specificity, PPV, LR+, and LR\u2212. It was decided that sensitivity and NPV, which we considered the most important properties of the J-IPV, should be at least \u2265.80. Based on the results of the two studies, it is suggested to use the following cutoffs for the different purposes of the J-IPV. 1) To detect ocal see . 4) To dnot factually involved in severe IPV is preferred above missing patients who are indeed involved in severe IPV. Moreover, patients who screened positive for severe IPV but were in fact not involved in severe IPV, were likely involved in non-severe IPV. Finally, likelihood ratios, ranging from 4.17\u20138.33 (LR+) and from 0\u2013.25 (LR\u2212), demonstrated that participants who screened positive were 4\u20138 times more likely than patients who screened negative to have perpetrated/experienced any/severe IPV, and that after screening negative, the odds were 0\u201325% to have perpetrated/experienced any/severe IPV. In sum, two independent studies demonstrated that the J-IPV is a valid screener with sensitivities and NPV\u2019s \u2265.80 to detect IPV in patients in substance abuse treatment. The second study replicated results from the first study, despite differences in population , and despite the fact that the first study was conducted in a large city and the second in a smaller town. Although it was expected that the second study would perform less than the first study For the other psychometric properties, the following results were found for the different cutoffs. AUCs that varied between.84 and.94 indicated that there was an 84\u201394% chance that a randomly selected perpetrator/victim of any/severe IPV scored higher on the J-IPV than a randomly selected patient that did not perpetrate/experience any/severe IPV. Further, specificities ranged from.79\u2013.88, indicating that 79\u201388% of factual non-IPV perpetrators screened indeed negative. PPV\u2019s were found between.45\u2013.80, indicating that 45\u201380% of all positive screening participants actually committed/experienced any/severe IPV in the past year. PPV\u2019s of the J-IPV to detect severe IPV perpetration and victimization were on the low side . However, we do not consider this problematic. The J-IPV is developed to screen for IPV and to identify patients in whom IPV should be further assessed. We argue that additional assessment of IPV in patients who are not to study the predictive validity of the CTS2 and the J-IPV. Further, it is noticeable that more men than women participated in the two studies. However, men are overrepresented in substance abuse treatment and this does not reflect a selection bias. Finally, in the second study, 31 patients (19.1%) were excluded from the study because of logistic reasons, such as that the intaker had forgotten to administer the J-IPV or that there was not sufficient time in the intake to administer the J-IPV and CTS2.There were several limitations to the study. In the first place, both the J-IPV and the CTS2 rely on self-report of participants, which implies that the results do not automatically reflect the physical violence that actually took place. Participants may deny or minimize the violence they have committed or were victimized by. On the other hand, although people tend to underreport violence in their relationship when completing the CTS In addition, there are several issues that should be addressed in future research. First, although the J-IPV demonstrated good psychometric properties in two different substance abuse treatment centers, these finding do not necessarily generalize to other settings , since psychometric properties depend on the prevalence of a \u2018disease\u2019 in a population severe IPV perpetration and/or victimization if limited time or resources are available. Second, using the J-IPV would help overcome personal barriers  to screening for IPV; the J-IPV is conducted as structured interview, which makes it easier for intakers to address this sensitive topic. Finally, also patient-related barriers  can be disputed on the basis of the present study. These problems are prevalent among patients in substance abuse treatment and no problems in administering the J-IPV have been encountered. An additional comment is that since Since the J-IPV demonstrated good psychometric properties, it is recommended to routinely administer the J-IPV, which is available in the public domain, during intakes in substance abuse treatment facilities. If patients answer \u2018yes\u2019 to one or more of four J-IPV questions, IPV should be further assessed (stepped assessment), for instance, by administering the CTS2. Also, when using the J-IPV, various barriers on screening for IPV as reported by not to screen for IPV in substance abuse treatment facilities.After a positive J-IPV score and careful subsequent assessment, appropriate treatment for IPV perpetrators and/or victims should be arranged. However, to date, no evidence-based treatments addressing IPV perpetration exist Appendix S1.(DOCX)Click here for additional data file.Charts S1Receiver operator characteristics (ROC)-curves to detect any and severe IPV perpetration and victimization for optimal scoring methods.(DOCX)Click here for additional data file.", "texts": ["About 50% of patients in substance abuse treatment with a partner perpetrated and/or experienced intimate partner violence in the past year. To date, there are no screeners to identify both perpetrators and victims of partner intimate violence in a substance abusing population. We developed a 4 item screening instrument for this purpose, the Jellinek Inventory for assessing Partner Violence (J-IPV). Important strengths of the J-IPV are that it takes only 2 minutes to administer and is easy to use and to score.To investigate the validity of the J-IPV, two independent studies were conducted including 98 and 99 participants, respectively. Aim of the second study was to cross-validate findings from the first study. Psychometric properties of the J-IPV were determined by calculating sensitivity, specificity, positive and negative predictive value, and positive and negative likelihood ratio\u2019s by comparing J-IPV outcomes to outcomes on the Revised Conflict Tactics Scales (\u2018gold standard\u2019). Also, receiver operator characteristics (ROC)-curves were determined to weight sensitivity and specificity as a result of different J-IPV cutoffs, and the area under the curve (AUC) was calculated.any as well as severe intimate partner violence. Results from the second study replicated findings from the first study.Results of the first study demonstrated that the J-IPV possesses good psychometric properties to detect perpetrators and victims of We recommend administering the J-IPV to patients entering substance abuse treatment. If perpetrators and victims of partner violence are identified, action can be taken to stop IPV perpetration and arrange help for victims, for example by offering perpetrators treatment or by providing safety planning or advocacy interventions to victims. Consequences of physical IPV can be severe for victims and may result in injuries, chronic pain, depression, posttraumatic stress disorder, suicidality, and substance use disorders ar e.g., .Because of the serious consequences of IPV and its high prevalence among patients in substance abuse treatment, it is important to assess IPV perpetration among these individuals. Ideally, IPV perpetrators should be identified at intake in order to prevent further assault of victims victimization of IPV in the past year; the latter two questions address perpetration of IPV in the past year  On the basis of the criteria described above we developed the 4 items counting Jellinek Inventory for assessing Partner Violence (J-IPV), a screener that takes only 2 minutes to administer, and is simple to use and score. The first two questions of the J-IPV address year see . The itell e.g., , it was To determine psychometric properties of the J-IPV for detecting 1) any IPV perpetration, 2) severe IPV perpetration, 3) any IPV victimization, and 4) severe IPV victimization, the following values were determined: 1) sensitivity , 2) specificity , 3) positive predictive value , and 4) negative predictive value  were computed. In addition, positive likelihood ratio  and negative likelihood ratio  were calculated as suggested, for example, by There are no universal criteria to determine the minimum standards of a screening instrument, since it depends on the situation whether greater value is attached to sensitivity or specificity The study was approved by the ethical committee of the University of Amsterdam (reference number 2010-kp-1350). Written informed consent was obtained from all participants.th 2011 and April 22nd 2011 in Amsterdam or between December 28th 2011 and October 17th 2012 in Hilversum. Patients were included if they 1) fulfilled DSM-IV-TR criteria for substance abuse or dependence (with the exclusion of nicotine dependence as the sole substance use disorder diagnosis), 2) had a partner for at least 3 months in the past year, 3) had sufficient knowledge of the Dutch language , and 4) were at least 18 years old. Patients were excluded in case of 1) severe withdrawal or intoxication symptoms during the intake, 2) severe mental illness , and 3) severe cognitive disorders, such as Korsakoff\u2019s syndrome or dementia.The two studies were conducted at two different locations of Jellinek, a large substance abuse treatment facility, in Amsterdam (study 1) and Hilversum (study 2), the Netherlands. Patients were included if they had an intake between February 28The J-IPV is a 4 item-screening device that was developed to assess IPV perpetration in patients entering substance abuse treatment. FK formulated the items of the J-IPV and EV, AS, and PE independently reviewed the items; the final items were based on consensus. The questions are administered as a structured interview and questions are answered with \u2018yes\u2019 or \u2018no\u2019. Two native English speakers translated the J-IPV from Dutch into English. Translations were compared with one another and led to the final English version of the J-IPV see .physical IPV, we only used item pairs assessing physical violence (2\u00d712 items). To make the transition to the physical violence items more gradual, firstly 3 items pairs addressing verbal violence were administered . Subsequently, the physical violence items of the CTS2 were administered in the same order in which they appear in the CTS2. The other CTS2 items were not used in this study. The physical violence items of the CTS2 were used to categorize participants as perpetrator and/or victim of any/severe physical IPV. Participants were rated as perpetrator of any IPV when answering \u2018yes\u2019 to at least one physical IPV perpetration item and were rated as victim of any IPV after at least one \u2018yes\u2019 to any of the physical IPV victimization items. Further, participants were classified as having perpetrated severe physical IPV or being victimized by severe physical IPV if at least one of the severe physical violence perpetration or victimization items was answered with \u201cyes\u201d. The adapted version of the CTS2 was administered as a structured interview, a method that was supported by The CTS2 The MATE During the intake, psychologists from the treatment staff who regularly conducted the intakes and were not involved in the factual studies administered the MATE. Subsequently, patients were informed about the study. If they agreed to participate, informed consent was obtained. Hereafter, the J-IPV and CTS2 were administered successively as structured interview. Since the aim of the study was to investigate whether the J-IPV predicted the outcome on the CTS2, we did not counterbalance administration of the J-IPV and CTS2. To help participants remember the 7-point rating scale of the CTS2, they were given a form with response categories written out. The first study was conducted at Jellinek Amsterdam; the second study at Jellinek Hilversum in order to cross-validate findings from the first study.Demographics of participants of the 2 studies were compared using chi-square tests for categorical variables ; an independent samples t-test for normally distributed continuous variables (age); and a Mann-Whitney test for nonnormally distributed continuous variables (relationship length). To determine psychometric properties of the J-IPV, sensitivity, specificity, PPV, NPV, LR+, LR\u2212, and AUC were calculated for the J-IPV compared to the CTS2 as \u2018gold standard\u2019  only both J-IPV perpetration items were used (items 3 and 4) and 3) the separate items addressing IPV perpetration (items 3 and 4) were used. Psychometric properties of the J-IPV to detect any/severe IPV victimization were determined when 1) all J-IPV items were used, 2) only both J-IPV victimization items were used (items 1 and 2) and 3) the separate items addressing IPV victimization (items 1 and 2) were used. After determining psychometric properties for these different options, the optimal cutoff or scoring method was selected to classify participants as 1) perpetrator of any IPV, 2) perpetrator of severe IPV, 3) victim of any IPV, and 4) victim of severe IPV. As mentioned in the introduction, we valued high sensitivity and NPV the most important psychometric properties the J-IPV should possess because it might be harmful to overlook perpetrators and victims of IPV. Therefore, the following steps were taken to decide on the optimal cutoff or scoring method. First, it was examined which cutoff or scoring method resulted in highest sensitivity and NPV. Then, it was observed whether this scoring method also yielded the highest AUC, and finally it was examined whether specificity and PPV were still acceptable.Prior to the start of this study, the J-IPV had been used in clinical practice for 20 months. Clinical observations taught that some patients who had committed physical IPV but saw themselves primarily as victim (and not perpetrator), did answer positively to one or both victimization items, but not to any of the perpetrator items. This demonstrates that people tend to underreport IPV perpetration e.g.,  but alsoA total of 115 participants met inclusion criteria. Seventeen participants (14.8%) were excluded: 7 participants (6.1%) refused participation, 5 (4.3%) suffered from severe mental illness, 4 (3.5%) dropped-out because of logistic reasons, and 1 (0.9%) suffered from a severe cognitive disorder see . The finOn the basis of the CTS2, participants were classified as 1) no perpetrator, no victim, 2) perpetrator only, 3) victim only, and 4) both perpetrator and victim of physical IPV see . About hA total of 158 participants met inclusion criteria. Fifty-nine participants (37.3%) were excluded: 8 participants (5.1%) refused participation, 11 (7.0%) suffered from severe mental problems, 4 (2.5%) suffered from a severe cognitive disorder; 2 (1.3%) were severely intoxicated, 3 (1.9%) dropped-out because the intaker was not yet trained in administering the J-IPV and CTS2, and 31 (19.6%) dropped-out because of logistic reasons see . The finIn addition, as in study 1, participants were classified as (non) perpetrator and/or victim of IPV see . Again, 2 (2)\u200a=\u200a6.21; p<.05). Standardized residuals indicated that more participants of study 1 had a non-European nationality than participants in study 2. In addition, participants of study 1 and 2 differed significantly form one another regarding relationship length (F (186)\u200a=\u200a4.52; p<.05); participants of study 2 had significantly longer relationships than participants of study 1. Participants of study 1 and 2 did not differ significantly regarding gender, age, living together, relationship at the time of the intake, children under 18, treatment intensity, and primary substance use disorder diagnosis. In addition, there were no differences between the 2 studies regarding prevalence rates of any/severe past year IPV perpetration/victimization. Also, there were no differences in rates of reciprocality of IPV  psychometric properties of both J-IPV perpetration items (items 3 and 4) were calculated, and 3), diagnostic efficiency was calculated for items 3 and 4, separately (see any of the J-IPV items) resulted in highest sensitivity (.80) and NPV (.85) (the indicators that were decided to be most important to the J-IPV). Also, the largest AUC (.80) was obtained when all 4 J-IPV items were used. In addition, specificity (.80) and PPV (.75) were still acceptable for this option, as well as LR+ (4.17), and an LR\u2212 (.24). For study 2, similar results were found   see . For illTo detect severe IPV perpetration, using a cutoff of 2 resulted in optimal psychometric properties in study 1  psychometric properties of both J-IPV victimization items (items 1 and 2) were calculated, and 3) diagnostic efficiency fore detecting IPV victimization was calculated for the separate victimization items (1 or 2). A cutoff of 1 resulted in the most favorable psychometric properties . Similar results were obtained in study 2 . ROC-curves are displayed in Psychometric properties for detecting any physical IPV victimization using CTS2 victimization items as \u2018gold standard\u2019 are displayed in severe physical IPV victimization were determined  and NPV . In other words, 80/84% of IPV perpetrators screened positive for IPV perpetration on the J-IPV; after screening negative, 85/82% of the participants had indeed not committed IPV. 2) To detect severe IPV perpetration, optimal results were found for a cutoff of 2, which resulted in sensitivity and NPV of 1.00 in both studies. 3) To detect any IPV victimization, we recommend using a cutoff of 1, which resulted in highest sensitivity (.83 and.80) and NPV (.87 and.86). It is noticeable that the same cutoff was suggested for detecting any IPV perpetration; this could be explained by the fact that in about 70% of the cases IPV was reciprocal .The aim of the present study was to validate and cross-validate the J-IPV by determining its sensitivity, NPV, AUC, specificity, PPV, LR+, and LR\u2212. It was decided that sensitivity and NPV, which we considered the most important properties of the J-IPV, should be at least \u2265.80. Based on the results of the two studies, it is suggested to use the following cutoffs for the different purposes of the J-IPV. 1) To detect ocal see . 4) To dnot factually involved in severe IPV is preferred above missing patients who are indeed involved in severe IPV. Moreover, patients who screened positive for severe IPV but were in fact not involved in severe IPV, were likely involved in non-severe IPV. Finally, likelihood ratios, ranging from 4.17\u20138.33 (LR+) and from 0\u2013.25 (LR\u2212), demonstrated that participants who screened positive were 4\u20138 times more likely than patients who screened negative to have perpetrated/experienced any/severe IPV, and that after screening negative, the odds were 0\u201325% to have perpetrated/experienced any/severe IPV. In sum, two independent studies demonstrated that the J-IPV is a valid screener with sensitivities and NPV\u2019s \u2265.80 to detect IPV in patients in substance abuse treatment. The second study replicated results from the first study, despite differences in population , and despite the fact that the first study was conducted in a large city and the second in a smaller town. Although it was expected that the second study would perform less than the first study For the other psychometric properties, the following results were found for the different cutoffs. AUCs that varied between.84 and.94 indicated that there was an 84\u201394% chance that a randomly selected perpetrator/victim of any/severe IPV scored higher on the J-IPV than a randomly selected patient that did not perpetrate/experience any/severe IPV. Further, specificities ranged from.79\u2013.88, indicating that 79\u201388% of factual non-IPV perpetrators screened indeed negative. PPV\u2019s were found between.45\u2013.80, indicating that 45\u201380% of all positive screening participants actually committed/experienced any/severe IPV in the past year. PPV\u2019s of the J-IPV to detect severe IPV perpetration and victimization were on the low side . However, we do not consider this problematic. The J-IPV is developed to screen for IPV and to identify patients in whom IPV should be further assessed. We argue that additional assessment of IPV in patients who are not to study the predictive validity of the CTS2 and the J-IPV. Further, it is noticeable that more men than women participated in the two studies. However, men are overrepresented in substance abuse treatment and this does not reflect a selection bias. Finally, in the second study, 31 patients (19.1%) were excluded from the study because of logistic reasons, such as that the intaker had forgotten to administer the J-IPV or that there was not sufficient time in the intake to administer the J-IPV and CTS2.There were several limitations to the study. In the first place, both the J-IPV and the CTS2 rely on self-report of participants, which implies that the results do not automatically reflect the physical violence that actually took place. Participants may deny or minimize the violence they have committed or were victimized by. On the other hand, although people tend to underreport violence in their relationship when completing the CTS In addition, there are several issues that should be addressed in future research. First, although the J-IPV demonstrated good psychometric properties in two different substance abuse treatment centers, these finding do not necessarily generalize to other settings , since psychometric properties depend on the prevalence of a \u2018disease\u2019 in a population severe IPV perpetration and/or victimization if limited time or resources are available. Second, using the J-IPV would help overcome personal barriers  to screening for IPV; the J-IPV is conducted as structured interview, which makes it easier for intakers to address this sensitive topic. Finally, also patient-related barriers  can be disputed on the basis of the present study. These problems are prevalent among patients in substance abuse treatment and no problems in administering the J-IPV have been encountered. An additional comment is that since Since the J-IPV demonstrated good psychometric properties, it is recommended to routinely administer the J-IPV, which is available in the public domain, during intakes in substance abuse treatment facilities. If patients answer \u2018yes\u2019 to one or more of four J-IPV questions, IPV should be further assessed (stepped assessment), for instance, by administering the CTS2. Also, when using the J-IPV, various barriers on screening for IPV as reported by not to screen for IPV in substance abuse treatment facilities.After a positive J-IPV score and careful subsequent assessment, appropriate treatment for IPV perpetrators and/or victims should be arranged. However, to date, no evidence-based treatments addressing IPV perpetration exist Appendix S1.(DOCX)Click here for additional data file.Charts S1Receiver operator characteristics (ROC)-curves to detect any and severe IPV perpetration and victimization for optimal scoring methods.(DOCX)Click here for additional data file."]}
{"representative": "Intimate partner violence (IPV) against women is a global public health and human rights concern. Despite a growing body of research into risk factors for IPV, methodological differences limit the extent to which comparisons can be made between studies. We used data from ten countries included in the WHO Multi-country Study on Women's Health and Domestic Violence to identify factors that are consistently associated with abuse across sites, in order to inform the design of IPV prevention programs.Standardised population-based household surveys were done between 2000 and 2003. One woman aged 15-49 years was randomly selected from each sampled household. Those who had ever had a male partner were asked about their experiences of physically and sexually violent acts. We performed multivariate logistic regression to identify predictors of physical and/or sexual partner violence within the past 12 months.Despite wide variations in the prevalence of IPV, many factors affected IPV risk similarly across sites. Secondary education, high SES, and formal marriage offered protection, while alcohol abuse, cohabitation, young age, attitudes supportive of wife beating, having outside sexual partners, experiencing childhood abuse, growing up with domestic violence, and experiencing or perpetrating other forms of violence in adulthood, increased the risk of IPV. The strength of the association was greatest when both the woman and her partner had the risk factor.IPV prevention programs should increase focus on transforming gender norms and attitudes, addressing childhood abuse, and reducing harmful drinking. Development initiatives to improve access to education for girls and boys may also have an important role in violence prevention. Intimate partner violence (IPV) against women is a global human rights and public health concern. The WHO Multi-Country Study on Women's Health and Domestic Violence documented the widespread nature of IPV , with liDesigning effective IPV prevention programmes involves identification of risk factors--both those that are direct causes of IPV, and those that point to common characteristics of victims and/or perpetrators thus allowing appropriate tailoring and targeting of services. Studies in various countries have identified a range of factors that influence IPV risk -13, but It is difficult to make comparisons between settings using existing individual studies as differences in identified risk factors may either be methodological artefacts or a real reflection of contrasting phenomena. Selected Demographic and Health Surveys ,15 have We use population-based data from the WHO Multi-Country Study on Women's Health and Domestic Violence, which was specifically designed to better understand the factors associated with violence in different settings. Comparability of data was maximised through use of a standardised questionnaire, standardised interviewer training and data-collection procedures across all participating sites, and a rigorous set of quality control procedures. We drew on current models of IPV risk, including those of Heise ,18 and JDetails of the study methods, sampling, response rates, and prevalence of different types of partner violence in each setting have been reported elsewhere  see Add. BrieflyTrained female interviewers completed interviews with one randomly selected woman aged 15-49 from each sampled household. 24,097 women were interviewed in total, using a standardised questionnaire which was developed by the study team and translated into 14 languages.Specially developed ethical guidelines emphasised the importance of ensuring confidentiality and privacy, both to protect the safety of respondents and field staff and to improve the quality of the data . Ethical1 The analysis compared women who reported having experienced any act of physical and/or sexual violence in the past year  with women who did not report any partner violence ('current' versus 'never'). Those who had experienced partner violence during their lifetime but not in the past year were excluded from the analysis so as not to dilute associations.Currently- or previously-partnered women were asked a series of questions about whether they had ever experienced specific violent acts  between early-life experiences and later IPV. Clustering of outcomes in each site was 'small'  ; hence wa priori) across the site-models except for the addition of certain relationship characteristics (polygamy and bride price/dowry) that were only relevant in some sites. As our overall aim was to identify similarities and differences in patterns of association between settings, we did not attempt to fit the most parsimonious model for each site. Neither did we place too much emphasis on the statistical significance of individual associations. Instead we focused on exploring the extent to which, keeping all other features of the model constant, patterns of associations were similar or different between sites.We included the same variables  between 0.95 > OR < 1.05 as indicative of no association, ORs of 1.05 or greater as risk-factors for IPV, and ORs of 0.95 or less as protective-factors for IPV. We use the terms risk- and protective-factors loosely to indicate the direction of association with IPV rather than to imply causality, as we are analysing cross-sectional data. Statistical significance is considered at the 5% level.19,517 women reported having ever had a partner and were thus asked about partner violence. In total, having excluded women reporting lifetime but not past-year experience of violence, and those with missing data for key variables in the models, 15,207 women were included in the 'prior to relationship' analyses, and 15,058 in the 'current situation' analyses . Achieving secondary education  by either the woman or her partner was associated with decreased IPV in almost two thirds of the sites (3 significant for each partner), when compared to situations where neither the woman nor her partner completed the level. However, the most consistent protective effect against IPV was observed where both the woman and her partner had completed the relevant schooling level . This most highly educated exposure group also had the lowest ORs for IPV in 10 out of 14 sites, compared to couples where one or both had not completed the level.A history of abuse was strongly associated with the occurrence of IPV, with reports of abuse of the woman's mother, her partners' mother, or both (compared to no known reported abuse of either mother) being associated with increased risk of IPV in all sites . ORs for IPV tended to be highest where women reported that both their mothers and their partners' mothers experienced abuse (observed in 10/15 sites). Evidence from bivariate analysis in most sites showed that women who did not know whether their partners had histories of abuse were also at increased risk of IPV compared to those who reported their partners did not have these experiences.Other experiences of violence were also associated with past year IPV, with a history of childhood sexual abuse of the woman, childhood beatings of her partner, or both consistently associated with increased risk of IPV, compared to no reports of abuse by either partner . Women in relationships where both she and her partner were abused in childhood are at the highest risk of IPV (true in 11/14 sites), . A similar pattern was seen in bivariate analysis for partner's age but this variable was excluded from multivariate models due to its strong correlation with the woman's age. In contrast, associations between IPV and an age-gap of at least 5 years between the woman and her partner were weak in most settings and the direction of the effect was context dependent. Older age of the woman was often associated with increased risk of IPV, but in only three out of fifteen sites was older age of the partner associated with increased risk of IPV. Weak associations were also seen in the other direction for age-gaps favouring either the woman or her partner.There was some suggestion that inequality in educational level between a woman and her partner may increase her risk of experiencing IPV. This was true in nine out of 15 sites where the woman had the higher level of education (1 significant), and the same where her partner had the higher level. Associations tended to be weak, however, and some were also observed in the opposite direction.There was no consistent pattern of association between IPV and relative employment status. Compared to couples in which both partners work, couples where just the man works appear to experience slightly lower levels of IPV in some settings . In some settings women who work when their partners do not may be at increased risk of IPV . There is some evidence that women in relationships where neither she nor her partner work are at increased risk of IPV . However, non-significant associations in opposite directions are also observed for these variables.Higher socioeconomic status (SES) was associated with decreased IPV in fourteen sites (significant in 8 sites when comparing the highest status group to the lowest). This variable was more strongly associated with IPV before adjustment for other variables that may confound or mediate the effects of socioeconomic status on IPV risk.In almost all sites, women who had attitudes supportive of a husband beating his wife had increased odds of IPV .In all sites odds of IPV were higher in relationships where one or both partners had problems with alcohol, compared to relationships where neither of them did . In the majority of sites frequent drunkenness among men yielded higher ORs for IPV than problematic drinking by the woman (8/11), and in ten of the eleven sites ORs were higher when both had problems with alcohol.Both a woman's experience of non-partner violence and her partner's involvement in fights with other men emerged as strong risk factors for IPV. Women's experiences of non-partner physical or sexual abuse over the age of 15 emerged as a risk-factor for IPV in almost all sites . Likewise, women whose partners were involved in a fight with another man in the past year experienced higher levels of IPV than those with partners who did not fight (significant in 13/15 sites). These factors were more strongly associated with IPV risk in the bivariate analysis. It is likely that both IPV and non-partner violence share common antecedents, such as CSA in the case of women, or a history of antisocial personality and alcohol abuse among men, which may account for all or part of this association ,24Women with children from previous relationships were at increased risk of experiencing IPV in most sites . Women whose partners had had relationships with other women during their relationship also experienced higher levels of IPV than women with faithful partners (significant in 14/15 sites). Lack of knowledge/disclosure about a partner's involvement with other women was also associated with increased IPV in most sites.Women who were cohabiting with a partner without being formally married were at increased risk of IPV . By contrast, women not living with their partners experienced lower levels of IPV . There was some suggestion that those in newer relationships were at increased risk of IPV, with higher levels of IPV in relationships of less than five years compared to longer relationships, in half of the sites (mostly non-significant). There were also several sites where weak associations in the opposite direction were seen for the newest relationships (5).A woman's participation in her choice of husband was associated with IPV differently across sites. In 6 out of 15 sites her lack of participation was associated with higher levels of IPV (3 significant), while in 8 sites it was associated with decreased IPV (1 significant).Payment of dowry and bride price  was associated with IPV in some sites, though patterns of risk were difficult to interpret. In the 6 sites where dowry was paid, it was associated with higher levels of IPV in 4 sites (3 significant) and lower IPV in 1 site (not significant). Bride price was associated with decreased IPV in 4 sites (2 significant) and increased IPV in two sites (neither significant).Women whose husbands had more than one wife were at increased risk of IPV in all 6 sites where polygamy is practised . The same was true for women who reported not knowing whether their husbands had other wives, compared to those who knew.Despite the wide variations in the prevalence of IPV across the study sites, many risk factors appear to affect IPV risk similarly, with secondary education, high SES, and formal marriage offering protection, and alcohol abuse, cohabitation, young age, attitudes supporting wife beating, outside sexual relationships, experiencing childhood abuse, growing up with domestic violence, and perpetrating or experiencing other forms of violence in adulthood, increasing the risk of IPV. We also found that the strength of the association was greater when both the woman and her partner had the risk or protective factor, suggesting the possibility of achieving greater prevention impact through targeting programs to couples most at risk.Overall, our analysis demonstrates far more consistency in risk and protective factors across sites than reported by Hindin and Kishor in their analysis of violence among couples from 10 recent Demographic and Health Surveys (DHS) . Among tOur analysis confirms that completing secondary education has a protective effect on IPV risk, whereas primary education alone fails to confer similar benefits . StudiesHigher socioeconomic status is generally associated with lower levels of physical and/or sexual partner violence. Even if it is not an independent or proximate risk factor but one that is partially confounded by or mediated through other factors , socioeconomic status of households should be taken into account when designing and targeting IPV intervention programmes .Early life experiences of abuse  emerge as consistently strong risk factors for IPV. In order to intervene in this inter-generational cycle of abuse, interventions must address childhood abuse and respond appropriately to children who have witnessed IPV against their mothers. Although the importance of the sexual abuse of children and the witnessing of marital violence by children has been documented in other studies, the potential importance of the physical abuse of boys has received less attention and merits further exploration. The consistent association between IPV and other forms of violence against women also point to the need for integrated responses to violence across sectors and programmes ,31. For Male behaviours commonly associated with 'traditional' masculinity , such asProblematic alcohol use, among both women and their partners, is consistently and strongly associated with IPV. While it is difficult to establish the temporality of the observed associations, this relationship has been repeatedly been demonstrated in studies of IPV ,34-36. HImportantly, not all variables demonstrated consistent relationships with IPV across sites, suggesting that policymakers should be cautious about any 'one model fits all' approach to IPV prevention. For example, risk associated with age disparity among partners, a woman working where her partner does not, and a woman taking an active role in choosing her partner, varies by setting. What constitutes empowerment in one setting may represent an unacceptable transgression of gender norms elsewhere. Jewkes highlights that transgression of gender norms and failure to fulfil cultural expectations of good womanhood and successful manhood are among the most important triggers for intimate partner violence . She argThe primary strength of our analysis is that it is based on fully comparable data from 15 culturally, economically and socially diverse sites. This type of comparison has not been possible to date in the field of IPV research, with the exception of the less tightly controlled DHS surveys. Obviously, the cross-sectional nature of this study limits the extent to which we can draw conclusions regarding temporality or the causal nature of observed associations. However, by distinguishing between early life and current characteristics, we do separate out those factors where temporality is clear from those where it is less certain.A further limitation is that the study interviewed only women, and hence relies on women's reports of their partner's characteristics. The data on partner characteristics refers to the woman's current or most recent partner, who in some cases may not be the perpetrator of the reported violence. Since the analysis considers only past year IPV, however, the number of cases where the reported violence was perpetrated by a more distant partner is likely to be small. Any resulting misclassification would bias results towards the null rather than invalidate observed associations.The multi-faceted nature of the factors that influence partner violence highlights the need for a multi-sectoral response that combines development activities, including improved access to secondary education for girls and boys, with initiatives to transform gender norms and attitudes, address prior histories of abuse, and reduce harmful drinking. Since risk of IPV is highest in younger women, schools are also an important setting for primary prevention activities, with potential to address issues of relationships, gender roles, power and coercion within existing youth violence and bullying programmes. Although there is no magic bullet to reduce partner violence, the consistency of our findings across sites suggests that a prevention strategy, once validated and refined, might have relevance in a wide range of settings. Initiatives to reduce partner violence require commitment and vision--by the international community, local governments and civil society. The time to act is now. As highlighted in the recent UN Campaign against violence against women--Women Won't Wait--such responses are urgently needed.IPV: intimate partner violence; CSA: childhood sexual abuse; DHS: Demographic and Health Survey; SES: socioeconomic status; WHO: World Health Organisation; UN: United Nations;The authors declare that they have no competing interests.CG-M, HAFMJ, ME, LH and CHW all participated in the study design and implementation. CG-M was the study coordinator. HAFMJ set up and supported data collection and processing in the countries and managed the central database. TA carried out the statistical analysis for this paper and drafted the manuscript. LH and CW helped draft the manuscript. KD and LK provided support with the statistical analysis and helped draft the manuscript. CG-M reviewed a draft of the manuscript. All authors read and approved the final manuscript.1Women were defined as ever partnered if they had ever been married or lived with a partner (and therefore had been at risk of intimate partner violence). In practice, this definition varied slightly between countries in accordance with local notions of partnerships.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2458/11/109/prepubPrevalence of physical and/or sexual intimate partner violence among ever-partnered women, by site. Prevalence data on lifetime and past-year experience of physical and/or sexual intimate partner violence among ever-partnered women for each of the sites included in the WHO study. These data are among those core study findings previously published in the Lancet :1260-1269.Click here for file", "texts": ["Intimate partner violence (IPV) against women is a global public health and human rights concern. Despite a growing body of research into risk factors for IPV, methodological differences limit the extent to which comparisons can be made between studies. We used data from ten countries included in the WHO Multi-country Study on Women's Health and Domestic Violence to identify factors that are consistently associated with abuse across sites, in order to inform the design of IPV prevention programs.Standardised population-based household surveys were done between 2000 and 2003. One woman aged 15-49 years was randomly selected from each sampled household. Those who had ever had a male partner were asked about their experiences of physically and sexually violent acts. We performed multivariate logistic regression to identify predictors of physical and/or sexual partner violence within the past 12 months.Despite wide variations in the prevalence of IPV, many factors affected IPV risk similarly across sites. Secondary education, high SES, and formal marriage offered protection, while alcohol abuse, cohabitation, young age, attitudes supportive of wife beating, having outside sexual partners, experiencing childhood abuse, growing up with domestic violence, and experiencing or perpetrating other forms of violence in adulthood, increased the risk of IPV. The strength of the association was greatest when both the woman and her partner had the risk factor.IPV prevention programs should increase focus on transforming gender norms and attitudes, addressing childhood abuse, and reducing harmful drinking. Development initiatives to improve access to education for girls and boys may also have an important role in violence prevention. Intimate partner violence (IPV) against women is a global human rights and public health concern. The WHO Multi-Country Study on Women's Health and Domestic Violence documented the widespread nature of IPV , with liDesigning effective IPV prevention programmes involves identification of risk factors--both those that are direct causes of IPV, and those that point to common characteristics of victims and/or perpetrators thus allowing appropriate tailoring and targeting of services. Studies in various countries have identified a range of factors that influence IPV risk -13, but It is difficult to make comparisons between settings using existing individual studies as differences in identified risk factors may either be methodological artefacts or a real reflection of contrasting phenomena. Selected Demographic and Health Surveys ,15 have We use population-based data from the WHO Multi-Country Study on Women's Health and Domestic Violence, which was specifically designed to better understand the factors associated with violence in different settings. Comparability of data was maximised through use of a standardised questionnaire, standardised interviewer training and data-collection procedures across all participating sites, and a rigorous set of quality control procedures. We drew on current models of IPV risk, including those of Heise ,18 and JDetails of the study methods, sampling, response rates, and prevalence of different types of partner violence in each setting have been reported elsewhere  see Add. BrieflyTrained female interviewers completed interviews with one randomly selected woman aged 15-49 from each sampled household. 24,097 women were interviewed in total, using a standardised questionnaire which was developed by the study team and translated into 14 languages.Specially developed ethical guidelines emphasised the importance of ensuring confidentiality and privacy, both to protect the safety of respondents and field staff and to improve the quality of the data . Ethical1 The analysis compared women who reported having experienced any act of physical and/or sexual violence in the past year  with women who did not report any partner violence ('current' versus 'never'). Those who had experienced partner violence during their lifetime but not in the past year were excluded from the analysis so as not to dilute associations.Currently- or previously-partnered women were asked a series of questions about whether they had ever experienced specific violent acts  between early-life experiences and later IPV. Clustering of outcomes in each site was 'small'  ; hence wa priori) across the site-models except for the addition of certain relationship characteristics (polygamy and bride price/dowry) that were only relevant in some sites. As our overall aim was to identify similarities and differences in patterns of association between settings, we did not attempt to fit the most parsimonious model for each site. Neither did we place too much emphasis on the statistical significance of individual associations. Instead we focused on exploring the extent to which, keeping all other features of the model constant, patterns of associations were similar or different between sites.We included the same variables  between 0.95 > OR < 1.05 as indicative of no association, ORs of 1.05 or greater as risk-factors for IPV, and ORs of 0.95 or less as protective-factors for IPV. We use the terms risk- and protective-factors loosely to indicate the direction of association with IPV rather than to imply causality, as we are analysing cross-sectional data. Statistical significance is considered at the 5% level.19,517 women reported having ever had a partner and were thus asked about partner violence. In total, having excluded women reporting lifetime but not past-year experience of violence, and those with missing data for key variables in the models, 15,207 women were included in the 'prior to relationship' analyses, and 15,058 in the 'current situation' analyses . Achieving secondary education  by either the woman or her partner was associated with decreased IPV in almost two thirds of the sites (3 significant for each partner), when compared to situations where neither the woman nor her partner completed the level. However, the most consistent protective effect against IPV was observed where both the woman and her partner had completed the relevant schooling level . This most highly educated exposure group also had the lowest ORs for IPV in 10 out of 14 sites, compared to couples where one or both had not completed the level.A history of abuse was strongly associated with the occurrence of IPV, with reports of abuse of the woman's mother, her partners' mother, or both (compared to no known reported abuse of either mother) being associated with increased risk of IPV in all sites . ORs for IPV tended to be highest where women reported that both their mothers and their partners' mothers experienced abuse (observed in 10/15 sites). Evidence from bivariate analysis in most sites showed that women who did not know whether their partners had histories of abuse were also at increased risk of IPV compared to those who reported their partners did not have these experiences.Other experiences of violence were also associated with past year IPV, with a history of childhood sexual abuse of the woman, childhood beatings of her partner, or both consistently associated with increased risk of IPV, compared to no reports of abuse by either partner . Women in relationships where both she and her partner were abused in childhood are at the highest risk of IPV (true in 11/14 sites), . A similar pattern was seen in bivariate analysis for partner's age but this variable was excluded from multivariate models due to its strong correlation with the woman's age. In contrast, associations between IPV and an age-gap of at least 5 years between the woman and her partner were weak in most settings and the direction of the effect was context dependent. Older age of the woman was often associated with increased risk of IPV, but in only three out of fifteen sites was older age of the partner associated with increased risk of IPV. Weak associations were also seen in the other direction for age-gaps favouring either the woman or her partner.There was some suggestion that inequality in educational level between a woman and her partner may increase her risk of experiencing IPV. This was true in nine out of 15 sites where the woman had the higher level of education (1 significant), and the same where her partner had the higher level. Associations tended to be weak, however, and some were also observed in the opposite direction.There was no consistent pattern of association between IPV and relative employment status. Compared to couples in which both partners work, couples where just the man works appear to experience slightly lower levels of IPV in some settings . In some settings women who work when their partners do not may be at increased risk of IPV . There is some evidence that women in relationships where neither she nor her partner work are at increased risk of IPV . However, non-significant associations in opposite directions are also observed for these variables.Higher socioeconomic status (SES) was associated with decreased IPV in fourteen sites (significant in 8 sites when comparing the highest status group to the lowest). This variable was more strongly associated with IPV before adjustment for other variables that may confound or mediate the effects of socioeconomic status on IPV risk.In almost all sites, women who had attitudes supportive of a husband beating his wife had increased odds of IPV .In all sites odds of IPV were higher in relationships where one or both partners had problems with alcohol, compared to relationships where neither of them did . In the majority of sites frequent drunkenness among men yielded higher ORs for IPV than problematic drinking by the woman (8/11), and in ten of the eleven sites ORs were higher when both had problems with alcohol.Both a woman's experience of non-partner violence and her partner's involvement in fights with other men emerged as strong risk factors for IPV. Women's experiences of non-partner physical or sexual abuse over the age of 15 emerged as a risk-factor for IPV in almost all sites . Likewise, women whose partners were involved in a fight with another man in the past year experienced higher levels of IPV than those with partners who did not fight (significant in 13/15 sites). These factors were more strongly associated with IPV risk in the bivariate analysis. It is likely that both IPV and non-partner violence share common antecedents, such as CSA in the case of women, or a history of antisocial personality and alcohol abuse among men, which may account for all or part of this association ,24Women with children from previous relationships were at increased risk of experiencing IPV in most sites . Women whose partners had had relationships with other women during their relationship also experienced higher levels of IPV than women with faithful partners (significant in 14/15 sites). Lack of knowledge/disclosure about a partner's involvement with other women was also associated with increased IPV in most sites.Women who were cohabiting with a partner without being formally married were at increased risk of IPV . By contrast, women not living with their partners experienced lower levels of IPV . There was some suggestion that those in newer relationships were at increased risk of IPV, with higher levels of IPV in relationships of less than five years compared to longer relationships, in half of the sites (mostly non-significant). There were also several sites where weak associations in the opposite direction were seen for the newest relationships (5).A woman's participation in her choice of husband was associated with IPV differently across sites. In 6 out of 15 sites her lack of participation was associated with higher levels of IPV (3 significant), while in 8 sites it was associated with decreased IPV (1 significant).Payment of dowry and bride price  was associated with IPV in some sites, though patterns of risk were difficult to interpret. In the 6 sites where dowry was paid, it was associated with higher levels of IPV in 4 sites (3 significant) and lower IPV in 1 site (not significant). Bride price was associated with decreased IPV in 4 sites (2 significant) and increased IPV in two sites (neither significant).Women whose husbands had more than one wife were at increased risk of IPV in all 6 sites where polygamy is practised . The same was true for women who reported not knowing whether their husbands had other wives, compared to those who knew.Despite the wide variations in the prevalence of IPV across the study sites, many risk factors appear to affect IPV risk similarly, with secondary education, high SES, and formal marriage offering protection, and alcohol abuse, cohabitation, young age, attitudes supporting wife beating, outside sexual relationships, experiencing childhood abuse, growing up with domestic violence, and perpetrating or experiencing other forms of violence in adulthood, increasing the risk of IPV. We also found that the strength of the association was greater when both the woman and her partner had the risk or protective factor, suggesting the possibility of achieving greater prevention impact through targeting programs to couples most at risk.Overall, our analysis demonstrates far more consistency in risk and protective factors across sites than reported by Hindin and Kishor in their analysis of violence among couples from 10 recent Demographic and Health Surveys (DHS) . Among tOur analysis confirms that completing secondary education has a protective effect on IPV risk, whereas primary education alone fails to confer similar benefits . StudiesHigher socioeconomic status is generally associated with lower levels of physical and/or sexual partner violence. Even if it is not an independent or proximate risk factor but one that is partially confounded by or mediated through other factors , socioeconomic status of households should be taken into account when designing and targeting IPV intervention programmes .Early life experiences of abuse  emerge as consistently strong risk factors for IPV. In order to intervene in this inter-generational cycle of abuse, interventions must address childhood abuse and respond appropriately to children who have witnessed IPV against their mothers. Although the importance of the sexual abuse of children and the witnessing of marital violence by children has been documented in other studies, the potential importance of the physical abuse of boys has received less attention and merits further exploration. The consistent association between IPV and other forms of violence against women also point to the need for integrated responses to violence across sectors and programmes ,31. For Male behaviours commonly associated with 'traditional' masculinity , such asProblematic alcohol use, among both women and their partners, is consistently and strongly associated with IPV. While it is difficult to establish the temporality of the observed associations, this relationship has been repeatedly been demonstrated in studies of IPV ,34-36. HImportantly, not all variables demonstrated consistent relationships with IPV across sites, suggesting that policymakers should be cautious about any 'one model fits all' approach to IPV prevention. For example, risk associated with age disparity among partners, a woman working where her partner does not, and a woman taking an active role in choosing her partner, varies by setting. What constitutes empowerment in one setting may represent an unacceptable transgression of gender norms elsewhere. Jewkes highlights that transgression of gender norms and failure to fulfil cultural expectations of good womanhood and successful manhood are among the most important triggers for intimate partner violence . She argThe primary strength of our analysis is that it is based on fully comparable data from 15 culturally, economically and socially diverse sites. This type of comparison has not been possible to date in the field of IPV research, with the exception of the less tightly controlled DHS surveys. Obviously, the cross-sectional nature of this study limits the extent to which we can draw conclusions regarding temporality or the causal nature of observed associations. However, by distinguishing between early life and current characteristics, we do separate out those factors where temporality is clear from those where it is less certain.A further limitation is that the study interviewed only women, and hence relies on women's reports of their partner's characteristics. The data on partner characteristics refers to the woman's current or most recent partner, who in some cases may not be the perpetrator of the reported violence. Since the analysis considers only past year IPV, however, the number of cases where the reported violence was perpetrated by a more distant partner is likely to be small. Any resulting misclassification would bias results towards the null rather than invalidate observed associations.The multi-faceted nature of the factors that influence partner violence highlights the need for a multi-sectoral response that combines development activities, including improved access to secondary education for girls and boys, with initiatives to transform gender norms and attitudes, address prior histories of abuse, and reduce harmful drinking. Since risk of IPV is highest in younger women, schools are also an important setting for primary prevention activities, with potential to address issues of relationships, gender roles, power and coercion within existing youth violence and bullying programmes. Although there is no magic bullet to reduce partner violence, the consistency of our findings across sites suggests that a prevention strategy, once validated and refined, might have relevance in a wide range of settings. Initiatives to reduce partner violence require commitment and vision--by the international community, local governments and civil society. The time to act is now. As highlighted in the recent UN Campaign against violence against women--Women Won't Wait--such responses are urgently needed.IPV: intimate partner violence; CSA: childhood sexual abuse; DHS: Demographic and Health Survey; SES: socioeconomic status; WHO: World Health Organisation; UN: United Nations;The authors declare that they have no competing interests.CG-M, HAFMJ, ME, LH and CHW all participated in the study design and implementation. CG-M was the study coordinator. HAFMJ set up and supported data collection and processing in the countries and managed the central database. TA carried out the statistical analysis for this paper and drafted the manuscript. LH and CW helped draft the manuscript. KD and LK provided support with the statistical analysis and helped draft the manuscript. CG-M reviewed a draft of the manuscript. All authors read and approved the final manuscript.1Women were defined as ever partnered if they had ever been married or lived with a partner (and therefore had been at risk of intimate partner violence). In practice, this definition varied slightly between countries in accordance with local notions of partnerships.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2458/11/109/prepubPrevalence of physical and/or sexual intimate partner violence among ever-partnered women, by site. Prevalence data on lifetime and past-year experience of physical and/or sexual intimate partner violence among ever-partnered women for each of the sites included in the WHO study. These data are among those core study findings previously published in the Lancet :1260-1269.Click here for file"]}
{"representative": "Serious forms of violence against women include Female Genital Mutilation (FGM) and Intimate Partner Violence (IPV). The aim of this study was to determine if FGM is associated with IPV, using data obtained from the Demographic and Health Survey (DHS) 2012 in Ivory Coast.Participants for this study were drawn from the 2011-12 Ivory Coast Demographic and Health Survey (CDHS), a nationally representative sample of 10060 women aged 15 to 49 years. The analysis of this paper is restricted to the sample of women who responded to the FGM and domestic violence modules (N\u2009=\u20095005).The lifetime prevalence of physical violence was 24.8%, sexual violence, 5.7%, and emotional violence, 19.0%, and the prevalence of any lifetime IPV was 32.1%. In all, 40.6% reported female genital cutting or mutilation (FGM). Women reporting FGM were two times as likely to experience sexual IPV , while other subtypes of IPV were higher in women reporting FGM but they were not significant. Of the socio-demographic covariates, urban residence and having a primary education were associated with most subtypes of IPV, while being a Muslim seemed protective from any type, sexual and emotional IPV. Having seen the father beating the mother was positively associated with most IPV subtypes, and having been diagnosed with a sexually transmitted infection (STI) in the previous 12 months was associated with physical and sexual IPV.Significant rates of FGM and IPV were found among this sample of Ivorian women calling for the need for multiple strategies to reduce FGM and IPV. Female genital mutilation (FGM) \u2013 defined by the World Health Organization (WHO) and the United Nations (UN) agencies as \u201cthe partial or total removal of the female external genitalia or other injury to the female genital organs for non-medical reasons\u201d is a deeply rooted tradition in many communities in 28 countries in Africa and in some countries in Asia and the Middle East , rangingAccording to WHO  the globTwo previous studies in Egypt and Mali have shown a positive association between FGM and intimate partner violence (IPV) ,9. SalihParticipants for this study were drawn from the 2011-12 Ivory Coast Demographic and Health Survey (CDHS), a nationally representative sample of 10060 women aged 15 to 49 years. The 2011/12 CDHS employed a two-stage stratified sample, where systematic sampling with probability proportional to size was applied [The questionnaire included demographic variables such as age, formal education, work status, residence, marriage type, religious denomination and wealth status, a composite index based on the household\u2019s ownership of consumer items such as television, car, drinking water, toilet facilities, etc.Female Genital Mutilation (FGM) was assessed from the survey item \u2018Respondent Circumcised,\u2019 which was a dichotomous (Yes/No) variable. Further, those who indicated that they had been circumcised were asked several items regarding circumcision, including \u2018flesh removed from the genital area\u2019, \u2018genital area just nicked without removing any flesh\u2019 and \u2018Genital area sewn closed\u2019 and the timing of circumcision [umcision .The domestic violence module of the Ivory Coast DHS includes 11 items that capture violence committed by a male partner or spouse. From these questions, IPV was categorised into three main subtypes: physical, sexual and emotional. Physical violence referred to any exposure to one or several of the following acts against women by a current or former husband or partner ever: i) pushing, shaking or throwing something at her; ii) slapping her or twisting her arm; iii) punching or hitting her with something harmful; iv) kicking or dragging her; v) strangling or burning her; vi) threatening her with a weapon (e.g. Gun or knife); and vii) attacking her with a weapon. Sexual violence referred to any exposure to one or several of the following acts against women by a current or former husband or partner ever: i) forced sexual intercourse; and ii) other sexual acts when undesired. Emotional IPV was assessed with two items, \u2018ever humiliation\u2019 and \u2018ever threatened harm\u2019, and was defined as a woman\u2019s report of ever experiencing an act of emotional violence by a partner. Exposure to each of these types of violent acts were scored as 1 (any experience of violence ever) and 0 (no experience of violence ever).Women were further categorised as those who experienced one type of IPV and those who experienced two or more types of IPV ,9.In addition, several risk factors for IPV were assessed, including increased risk of HIV/STI  and witnData analysis was performed using STATA software version 11.0 . The analysis in STATA took into account the multilevel stratified cluster sample design of the study. Frequencies as estimation of prevalence of IPV were obtained. Logistic regression analysis was conducted to estimate the association between relevant predictor variables including FGM and IPV. Adjusted odds ratios are reported for selected predictor variables  while considering IPV as a dependent variable. In the analysis, weighted percentages are reported. The reported sample size refers to the sample that was asked the target question. The two-sided 95% confidence intervals are reported. The p-value less or equal to 5% is used to indicate statistical significance. Both the reported 95% confidence intervals and the p-value are adjusted for the multi-stage stratified cluster sample design of the study.Overall, 5005 women were administered the domestic violence and female genital cutting modules of the 2012 Ivory Coast DHS. Their demographic characteristics are provided in Table\u00a0The adjusted odds ratios (AOR) and 95% confidence intervals (95% CI) for the association between FGM and IPV are shown in Table\u00a0The lifetime prevalence of IPV and its subtypes in the Ivory Coast seem lower than the average in the WHO African region . The preThe study findings show that FGM was only partially associated with IPV, namely with sexual violence only, while having witnessed interparental violence in childhood was found to be associated with most IPV subtypes; the latter was also found in a DHS survey in Bolivia . TherefoFurther, the study found that having been diagnosed with a sexually transmitted infection (STI) in the previous 12 months was associated with physical and sexual IPV. IPV has been identified to increase the risk of HIV/STI . Of the Caution should be taken when interpreting the results of this study due to certain limitations. Since this was a cross-sectional study, causality between the compared variables cannot be concluded. A further limitation was that some factors known to be contributing to IPV were not assessed .Significant rates of FGM and IPV were found among this sample of Ivorian women calling for the need for multiple strategies to reduce FGM and IPV.The authors declare that they have no competing interests.KP performed the analysis and drafted the manuscript. SP developed the idea of the analysis and provided comments on the manuscript. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1472-6874/14/13/prepub", "texts": ["Serious forms of violence against women include Female Genital Mutilation (FGM) and Intimate Partner Violence (IPV). The aim of this study was to determine if FGM is associated with IPV, using data obtained from the Demographic and Health Survey (DHS) 2012 in Ivory Coast.Participants for this study were drawn from the 2011-12 Ivory Coast Demographic and Health Survey (CDHS), a nationally representative sample of 10060 women aged 15 to 49 years. The analysis of this paper is restricted to the sample of women who responded to the FGM and domestic violence modules (N\u2009=\u20095005).The lifetime prevalence of physical violence was 24.8%, sexual violence, 5.7%, and emotional violence, 19.0%, and the prevalence of any lifetime IPV was 32.1%. In all, 40.6% reported female genital cutting or mutilation (FGM). Women reporting FGM were two times as likely to experience sexual IPV , while other subtypes of IPV were higher in women reporting FGM but they were not significant. Of the socio-demographic covariates, urban residence and having a primary education were associated with most subtypes of IPV, while being a Muslim seemed protective from any type, sexual and emotional IPV. Having seen the father beating the mother was positively associated with most IPV subtypes, and having been diagnosed with a sexually transmitted infection (STI) in the previous 12 months was associated with physical and sexual IPV.Significant rates of FGM and IPV were found among this sample of Ivorian women calling for the need for multiple strategies to reduce FGM and IPV. Female genital mutilation (FGM) \u2013 defined by the World Health Organization (WHO) and the United Nations (UN) agencies as \u201cthe partial or total removal of the female external genitalia or other injury to the female genital organs for non-medical reasons\u201d is a deeply rooted tradition in many communities in 28 countries in Africa and in some countries in Asia and the Middle East , rangingAccording to WHO  the globTwo previous studies in Egypt and Mali have shown a positive association between FGM and intimate partner violence (IPV) ,9. SalihParticipants for this study were drawn from the 2011-12 Ivory Coast Demographic and Health Survey (CDHS), a nationally representative sample of 10060 women aged 15 to 49 years. The 2011/12 CDHS employed a two-stage stratified sample, where systematic sampling with probability proportional to size was applied [The questionnaire included demographic variables such as age, formal education, work status, residence, marriage type, religious denomination and wealth status, a composite index based on the household\u2019s ownership of consumer items such as television, car, drinking water, toilet facilities, etc.Female Genital Mutilation (FGM) was assessed from the survey item \u2018Respondent Circumcised,\u2019 which was a dichotomous (Yes/No) variable. Further, those who indicated that they had been circumcised were asked several items regarding circumcision, including \u2018flesh removed from the genital area\u2019, \u2018genital area just nicked without removing any flesh\u2019 and \u2018Genital area sewn closed\u2019 and the timing of circumcision [umcision .The domestic violence module of the Ivory Coast DHS includes 11 items that capture violence committed by a male partner or spouse. From these questions, IPV was categorised into three main subtypes: physical, sexual and emotional. Physical violence referred to any exposure to one or several of the following acts against women by a current or former husband or partner ever: i) pushing, shaking or throwing something at her; ii) slapping her or twisting her arm; iii) punching or hitting her with something harmful; iv) kicking or dragging her; v) strangling or burning her; vi) threatening her with a weapon (e.g. Gun or knife); and vii) attacking her with a weapon. Sexual violence referred to any exposure to one or several of the following acts against women by a current or former husband or partner ever: i) forced sexual intercourse; and ii) other sexual acts when undesired. Emotional IPV was assessed with two items, \u2018ever humiliation\u2019 and \u2018ever threatened harm\u2019, and was defined as a woman\u2019s report of ever experiencing an act of emotional violence by a partner. Exposure to each of these types of violent acts were scored as 1 (any experience of violence ever) and 0 (no experience of violence ever).Women were further categorised as those who experienced one type of IPV and those who experienced two or more types of IPV ,9.In addition, several risk factors for IPV were assessed, including increased risk of HIV/STI  and witnData analysis was performed using STATA software version 11.0 . The analysis in STATA took into account the multilevel stratified cluster sample design of the study. Frequencies as estimation of prevalence of IPV were obtained. Logistic regression analysis was conducted to estimate the association between relevant predictor variables including FGM and IPV. Adjusted odds ratios are reported for selected predictor variables  while considering IPV as a dependent variable. In the analysis, weighted percentages are reported. The reported sample size refers to the sample that was asked the target question. The two-sided 95% confidence intervals are reported. The p-value less or equal to 5% is used to indicate statistical significance. Both the reported 95% confidence intervals and the p-value are adjusted for the multi-stage stratified cluster sample design of the study.Overall, 5005 women were administered the domestic violence and female genital cutting modules of the 2012 Ivory Coast DHS. Their demographic characteristics are provided in Table\u00a0The adjusted odds ratios (AOR) and 95% confidence intervals (95% CI) for the association between FGM and IPV are shown in Table\u00a0The lifetime prevalence of IPV and its subtypes in the Ivory Coast seem lower than the average in the WHO African region . The preThe study findings show that FGM was only partially associated with IPV, namely with sexual violence only, while having witnessed interparental violence in childhood was found to be associated with most IPV subtypes; the latter was also found in a DHS survey in Bolivia . TherefoFurther, the study found that having been diagnosed with a sexually transmitted infection (STI) in the previous 12 months was associated with physical and sexual IPV. IPV has been identified to increase the risk of HIV/STI . Of the Caution should be taken when interpreting the results of this study due to certain limitations. Since this was a cross-sectional study, causality between the compared variables cannot be concluded. A further limitation was that some factors known to be contributing to IPV were not assessed .Significant rates of FGM and IPV were found among this sample of Ivorian women calling for the need for multiple strategies to reduce FGM and IPV.The authors declare that they have no competing interests.KP performed the analysis and drafted the manuscript. SP developed the idea of the analysis and provided comments on the manuscript. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1472-6874/14/13/prepub"]}
{"representative": "To examine correlates of perpetration and victimization of intimate partner violence (IPV) under and not under the influence of a substance, we conducted a study among women in Russia.In 2011, a cross-sectional survey was conducted among patients receiving services at a clinic for sexually transmitted infections in St. Petersburg, Russia. Multinomial logistic regression was used for analysis.Of 299 women, 104 (34.8%) and 113 (37.8%) reported a history of IPV perpetration and victimization, respectively. Nearly half (47.1%) of perpetrators and 61.1% of victims reported that the latest IPV event  was experienced under the influence of a substance. Factors independently associated with IPV victimization under the influence of a substance were alcohol misuse and a higher number of lifetime sex partners, whereas only experience of childhood abuse  was independently associated with IPV victimization that did not occur under the influence of a substance. Childhood physical abuse, lower age of first sex, sensation seeking, and alcohol misuse were independently associated with IPV perpetration under the influence of a substance, while only childhood abuse  was independently associated with IPV perpetration that did not occur under the influence of a substance.IPV under and not under the influence of a substance had different correlates . Despite the strong association between substance use and IPV, experience of childhood abuse is an important predictor of IPV perpetration and victimization in Russia, above and beyond substance use. Intimate partner violence (IPV) has been a significant public concern worldwide due to its high prevalence and wide range of adverse health consequences such as injury, chronic pain, sexually transmitted infections (STIs) and mental health problems Although a variety of studies revealed that a number of factors are associated with IPV Experience of childhood abuse, particularly physical abuse, is another key factor that has been found to be consistently associated with IPV perpetration in different studies, including a cross-sectional study using data collected from a large representative U.S. national sample of couples  and a 20-year longitudinal study Sensation seeking is another factor associated with IPV. This association is less consistent in the literature partly because IPV is a complex phenomenon which may not be fully explained by a single factor or simple model Substance use, particularly alcohol and drug use, is an important public health problem in Russia, and has been associated with several negative outcomes including IPV and HIV risk behaviors This study used multinomial logistic regression to simultaneously investigate three levels of outcome: IPV under the influence of a substance, IPV not under the influence of a substance, and no IPV. The primary purpose of the present study was to examine correlates of perpetration and victimization of IPV under and not under the influence of a substance (each compared to no IPV) among women receiving health services in St. Petersburg, Russia. We hypothesized that: (1) IPV under and not under the influence of a substance has different correlates; (2) experience of childhood abuse is associated with IPV perpetration and victimization with and without the influence of a substance; and (3) sensation seeking is associated with IPV perpetration independently of whether it occurs under the influence of a substance.Consecutive adult patients (aged 18 years and older) who required STI services in a dermatovenereology dispensary (STI out-patient clinic) in St. Petersburg, Russia were invited to participate in a cross-sectional study which aimed to examine factors associated with female reproductive health from May 2011 to November 2011. A total of 502 patients agreed to participate in and completed a computer-assisted interviewer-administered questionnaire. Written informed consent was obtained from all participants and the study was approved by the institutional review boards of the Biomedical Center in St. Petersburg, Russia and Yale University, CT, USA. Of the 300 women recruited into the study, 299 answered the questions about intimate partner violence and therefore comprised the final analytic sample. The decision to include only women in the present analyses was made to reduce the complexity of research questions because women and men had different recruitment criteria. Eligibility for women\u2019s participation included: (1) age between 18 and 50; (2) sexually active during the past 6 month; (3) not trying to get pregnant; and (4) biologically able to have children.A questionnaire was used to collect information including demographic and health characteristics, alcohol and illicit drug use, sexual behaviors, sensation seeking and experience of violence including history of childhood abuse and IPV. The questionnaire was constructed in English, translated to Russian, and then translated back to English to ensure the integrity of the syntax and meaning. Demographic information included age at survey, marital status, level of education, employment status and income level.Alcohol and illicit drug use: Alcohol consumption was assessed using the Alcohol Use Disorders Identification Test (AUDIT) which includes 10 questions with a total score that ranges from 0 to 40 Sexual behaviors: Participants were asked the age of their first sexual experience and the number of sexual partners in their lifetime. Considering that some participants had a much higher number of sexual partners, this variable was dichotomized according to the median value.Sensation seeking: The Brief Sensation Seeking Scale (BSSS-8) developed by Hoyle et al. was used to measure sensation seeking History of childhood abuse: We assessed experiences of childhood abuse from two aspects, emotional abuse and physical abuse, respectively, based on two questions: \u201cHow often did your parent or caretaker insult, swear or threaten you\u201d and \u201cHow often did your parent or caretaker push, grab, pinch or beat you\u201d during their first 18 years. Although we asked a question related to childhood sexual abuse, \u201cHow often did your parent or caretaker touch you in a sexual way or had you touch him/her in a sexual way,\u201d only one woman had such an experience. Thus, childhood sexual abuse was not included in the present analysis. These questions were adapted from the Conflict Tactics Scale (CTS) and the response categories were never, rarely, frequently and way too frequentlyPerpetration and victimization of IPV: IPV perpetration was defined as having ever (a) insulted, sworn at, or threatened a sexual partner; (b) pushed, grabbed, slapped, punched, beaten up, or choked a sexual partner; or (c) physically forced a sexual partner to have sex or do something sexually that he or she did not want to do. IPV victimization was defined as having ever been the target of the aforementioned actions by a sexual partner. These partner violence items were adapted from the CTS and have been successfully used in Russia to measure intimate partner violence p<.05 and the data were analyzed using SAS software version 9.1 .Chi-square tests and ANOVA  F-tests were used to examine group differences by last IPV status  for categorical and continuous variables, respectively. Multinomial logistic regression was used to determine significant correlates of IPV under and not under the influence of a substance. None of the demographic characteristics were significantly associated with either IPV perpetration or victimization in the multinomial logistic regression; therefore they were not included in the final models. The significance level was defined as p\u200a=\u200a0.01). Other characteristics were not significantly different across status of last IPV victimization.The mean age of the participants was 28 years (standard deviation\u200a=\u200a7.8), ranging from 18 to 50 years. Nearly 50% of the participants were married, 42% were never married and the rest were divorced, widowed or separated. About 49% of the participants had completed university or higher education. The majority (57%) of the participants were full-time employed and 43% had monthly incomes below 15,000 rubles (about 500 U.S. dollars). None of these demographic characteristics differed by status of last IPV perpetration . When these demographic characteristics were compared by status of last IPV victimization , however, age of the participants was significantly different . Among 190 women who had experience of childhood abuse, 118 (62.1%) only had experience of childhood emotional abuse and 72 (37.9%) had childhood physical abuse experience with 70 of 72 reporting both experiences.Both IPV perpetration and victimization were common. Of the women in the study, one did not answer IPV questions; 104 (34.8%) reported a history of IPV perpetration and 113 (37.8%) reported a history of IPV victimization, with 75 (25.1%) reporting both perpetration and victimization experiences in their lives. More specifically, the percentages of women who experienced verbal, physical and sexual IPV were 32.1, 18.1 and 11.0%, respectively; the percentages of women who perpetrated verbal, physical and sexual IPV were 28.4, 21.4 and 2.7%, respectively. Of 104 women who had ever perpetrated IPV, 49 (47.1%) reported last perpetration under the influence of a substance. Among 113 women who had ever been a victim of IPV, 69 (60.6%) reported last victimization under the influence of a substance.p-values ranging from <.0001 to 0.001 , in which couples with experience of IPV had higher sensation seeking scores than those without IPV experience As with most studies, our study is not without limitations. First and foremost, our data may be subject to recall bias. The measurement of experience of childhood abuse and last IPV under and not under the influence of a substance was based upon self-reporting. It is possible that participants may not accurately recall their exposure to violence in their childhood and exposure to substance if the last IPV occurred many years ago. The misclassification resulting from recall bias is likely to attenuate the observed association. Second, the measurement of IPV may also be subject to social desirability bias. As a result, IPV may be underreported. Furthermore, some participants may use substances as an excuse for their IPV acts even in a situation where no substance was actually involved in their last IPV episode. However this possibility should be low since the proportion of IPV under the influence of a substance in the present study is consistent with results from other studies In conclusion, IPV under and not under the influence of a substance had different correlates  and experience of childhood abuse can be an important predictor of IPV perpetration and victimization, above and beyond substance use. The findings also support the growing body of work suggesting that, in addition to childhood physical abuse, childhood emotional abuse only can be a risk factor of IPV which warrants more research and clinical attention.", "texts": ["To examine correlates of perpetration and victimization of intimate partner violence (IPV) under and not under the influence of a substance, we conducted a study among women in Russia.In 2011, a cross-sectional survey was conducted among patients receiving services at a clinic for sexually transmitted infections in St. Petersburg, Russia. Multinomial logistic regression was used for analysis.Of 299 women, 104 (34.8%) and 113 (37.8%) reported a history of IPV perpetration and victimization, respectively. Nearly half (47.1%) of perpetrators and 61.1% of victims reported that the latest IPV event  was experienced under the influence of a substance. Factors independently associated with IPV victimization under the influence of a substance were alcohol misuse and a higher number of lifetime sex partners, whereas only experience of childhood abuse  was independently associated with IPV victimization that did not occur under the influence of a substance. Childhood physical abuse, lower age of first sex, sensation seeking, and alcohol misuse were independently associated with IPV perpetration under the influence of a substance, while only childhood abuse  was independently associated with IPV perpetration that did not occur under the influence of a substance.IPV under and not under the influence of a substance had different correlates . Despite the strong association between substance use and IPV, experience of childhood abuse is an important predictor of IPV perpetration and victimization in Russia, above and beyond substance use. Intimate partner violence (IPV) has been a significant public concern worldwide due to its high prevalence and wide range of adverse health consequences such as injury, chronic pain, sexually transmitted infections (STIs) and mental health problems Although a variety of studies revealed that a number of factors are associated with IPV Experience of childhood abuse, particularly physical abuse, is another key factor that has been found to be consistently associated with IPV perpetration in different studies, including a cross-sectional study using data collected from a large representative U.S. national sample of couples  and a 20-year longitudinal study Sensation seeking is another factor associated with IPV. This association is less consistent in the literature partly because IPV is a complex phenomenon which may not be fully explained by a single factor or simple model Substance use, particularly alcohol and drug use, is an important public health problem in Russia, and has been associated with several negative outcomes including IPV and HIV risk behaviors This study used multinomial logistic regression to simultaneously investigate three levels of outcome: IPV under the influence of a substance, IPV not under the influence of a substance, and no IPV. The primary purpose of the present study was to examine correlates of perpetration and victimization of IPV under and not under the influence of a substance (each compared to no IPV) among women receiving health services in St. Petersburg, Russia. We hypothesized that: (1) IPV under and not under the influence of a substance has different correlates; (2) experience of childhood abuse is associated with IPV perpetration and victimization with and without the influence of a substance; and (3) sensation seeking is associated with IPV perpetration independently of whether it occurs under the influence of a substance.Consecutive adult patients (aged 18 years and older) who required STI services in a dermatovenereology dispensary (STI out-patient clinic) in St. Petersburg, Russia were invited to participate in a cross-sectional study which aimed to examine factors associated with female reproductive health from May 2011 to November 2011. A total of 502 patients agreed to participate in and completed a computer-assisted interviewer-administered questionnaire. Written informed consent was obtained from all participants and the study was approved by the institutional review boards of the Biomedical Center in St. Petersburg, Russia and Yale University, CT, USA. Of the 300 women recruited into the study, 299 answered the questions about intimate partner violence and therefore comprised the final analytic sample. The decision to include only women in the present analyses was made to reduce the complexity of research questions because women and men had different recruitment criteria. Eligibility for women\u2019s participation included: (1) age between 18 and 50; (2) sexually active during the past 6 month; (3) not trying to get pregnant; and (4) biologically able to have children.A questionnaire was used to collect information including demographic and health characteristics, alcohol and illicit drug use, sexual behaviors, sensation seeking and experience of violence including history of childhood abuse and IPV. The questionnaire was constructed in English, translated to Russian, and then translated back to English to ensure the integrity of the syntax and meaning. Demographic information included age at survey, marital status, level of education, employment status and income level.Alcohol and illicit drug use: Alcohol consumption was assessed using the Alcohol Use Disorders Identification Test (AUDIT) which includes 10 questions with a total score that ranges from 0 to 40 Sexual behaviors: Participants were asked the age of their first sexual experience and the number of sexual partners in their lifetime. Considering that some participants had a much higher number of sexual partners, this variable was dichotomized according to the median value.Sensation seeking: The Brief Sensation Seeking Scale (BSSS-8) developed by Hoyle et al. was used to measure sensation seeking History of childhood abuse: We assessed experiences of childhood abuse from two aspects, emotional abuse and physical abuse, respectively, based on two questions: \u201cHow often did your parent or caretaker insult, swear or threaten you\u201d and \u201cHow often did your parent or caretaker push, grab, pinch or beat you\u201d during their first 18 years. Although we asked a question related to childhood sexual abuse, \u201cHow often did your parent or caretaker touch you in a sexual way or had you touch him/her in a sexual way,\u201d only one woman had such an experience. Thus, childhood sexual abuse was not included in the present analysis. These questions were adapted from the Conflict Tactics Scale (CTS) and the response categories were never, rarely, frequently and way too frequentlyPerpetration and victimization of IPV: IPV perpetration was defined as having ever (a) insulted, sworn at, or threatened a sexual partner; (b) pushed, grabbed, slapped, punched, beaten up, or choked a sexual partner; or (c) physically forced a sexual partner to have sex or do something sexually that he or she did not want to do. IPV victimization was defined as having ever been the target of the aforementioned actions by a sexual partner. These partner violence items were adapted from the CTS and have been successfully used in Russia to measure intimate partner violence p<.05 and the data were analyzed using SAS software version 9.1 .Chi-square tests and ANOVA  F-tests were used to examine group differences by last IPV status  for categorical and continuous variables, respectively. Multinomial logistic regression was used to determine significant correlates of IPV under and not under the influence of a substance. None of the demographic characteristics were significantly associated with either IPV perpetration or victimization in the multinomial logistic regression; therefore they were not included in the final models. The significance level was defined as p\u200a=\u200a0.01). Other characteristics were not significantly different across status of last IPV victimization.The mean age of the participants was 28 years (standard deviation\u200a=\u200a7.8), ranging from 18 to 50 years. Nearly 50% of the participants were married, 42% were never married and the rest were divorced, widowed or separated. About 49% of the participants had completed university or higher education. The majority (57%) of the participants were full-time employed and 43% had monthly incomes below 15,000 rubles (about 500 U.S. dollars). None of these demographic characteristics differed by status of last IPV perpetration . When these demographic characteristics were compared by status of last IPV victimization , however, age of the participants was significantly different . Among 190 women who had experience of childhood abuse, 118 (62.1%) only had experience of childhood emotional abuse and 72 (37.9%) had childhood physical abuse experience with 70 of 72 reporting both experiences.Both IPV perpetration and victimization were common. Of the women in the study, one did not answer IPV questions; 104 (34.8%) reported a history of IPV perpetration and 113 (37.8%) reported a history of IPV victimization, with 75 (25.1%) reporting both perpetration and victimization experiences in their lives. More specifically, the percentages of women who experienced verbal, physical and sexual IPV were 32.1, 18.1 and 11.0%, respectively; the percentages of women who perpetrated verbal, physical and sexual IPV were 28.4, 21.4 and 2.7%, respectively. Of 104 women who had ever perpetrated IPV, 49 (47.1%) reported last perpetration under the influence of a substance. Among 113 women who had ever been a victim of IPV, 69 (60.6%) reported last victimization under the influence of a substance.p-values ranging from <.0001 to 0.001 , in which couples with experience of IPV had higher sensation seeking scores than those without IPV experience As with most studies, our study is not without limitations. First and foremost, our data may be subject to recall bias. The measurement of experience of childhood abuse and last IPV under and not under the influence of a substance was based upon self-reporting. It is possible that participants may not accurately recall their exposure to violence in their childhood and exposure to substance if the last IPV occurred many years ago. The misclassification resulting from recall bias is likely to attenuate the observed association. Second, the measurement of IPV may also be subject to social desirability bias. As a result, IPV may be underreported. Furthermore, some participants may use substances as an excuse for their IPV acts even in a situation where no substance was actually involved in their last IPV episode. However this possibility should be low since the proportion of IPV under the influence of a substance in the present study is consistent with results from other studies In conclusion, IPV under and not under the influence of a substance had different correlates  and experience of childhood abuse can be an important predictor of IPV perpetration and victimization, above and beyond substance use. The findings also support the growing body of work suggesting that, in addition to childhood physical abuse, childhood emotional abuse only can be a risk factor of IPV which warrants more research and clinical attention."]}
{"representative": "Intimate partner violence (IPV) is widely prevalent in Tanzania. Inequitable gender norms manifest in men's and women's attitudes about power and decision making in intimate relationships and are likely to play an important role in determining the prevalence of IPV. We used data from the RESPECT study, a randomized controlled trial that evaluated an intervention to prevent sexually transmitted infections in a cohort of young Tanzanian men and women, to examine the relationship between couples' attitudes about IPV, relationship power, and sexual decision making, concordance on these issues, and women's reports of IPV over 12 months. Women expressed less equitable attitudes than men at baseline. Over time, participants' attitudes tended to become more equitable and women's reports of IPV declined substantially. Multivariable logistic regression analyses suggested that inequitable attitudes and couple discordance were associated with higher risk of IPV. Our findings point to the need for a better understanding of the role that perceived or actual imbalances in relationship power have in heightening IPV risk. The decline in women's reports of IPV and the trend towards gender-equitable attitudes indicate that concerted efforts to reduce IPV and promote gender equity have the potential to make a positive difference in the relatively short term. Intimate partner violence (IPV) is a major public health and human rights concern in Tanzania . AccordiIt is widely accepted that gender inequities, perpetuated by cultural norms regarding gender roles and manifest in men's and women's ideas about power and decision making in relationships, have a profound impact on the perpetration and experience of IPV . SeveralSurvey data lend support to the observation that both men and women in Tanzania condone IPV as a normal part of an intimate relationship , 13. AccAlthough research has explored men's and women's attitudes about IPV, few studies have empirically examined the association between these attitudes and IPV risk . For exaTo our knowledge, the association between couples' attitudes towards IPV, couple concordance in attitudes and IPV risk has not been examined in Tanzania. Using data from the Rewarding STI Prevention and Control in Tanzania (RESPECT) study, we examined men's and women's attitudes about IPV, relationship power, and sexual decision making and couples' concordance on these issues, and whether these attitudes were associated with women's experience of IPV at baseline and over time. The year-long RESPECT study was a randomized controlled trial designed to evaluate whether conditional cash transfers (CCT) promoted safe sex and reduced the incidence of sexually transmitted infections (STIs)  and perpetration of IPV (men). They also underwent STI and HIV counseling and testing. Participants in the CCT arms received cash payments for every 4 monthly negative STI laboratory test result. All enrolled individuals were invited to group counseling sessions that focused on relationship and life skills training based on the Stepping Stones curriculum . The analysis is guided by a social-ecological framework, which posits that IPV risk is shaped by the interplay of a host of individual, community, and societal factors, including individual beliefs and practices within an intimate relationship as well as community and societal norms regarding gender and power . It is aIn this analysis, we considered attitudes toward IPV as proximate determinants, and gender norms as a key underlying, distal determinant of IPV. For example, women's access to education and employment is limited in social and cultural environments that are highly patriarchal, increasing their economic dependence on male partners, which is a known risk factor for IPV  . SimilarWe outlined our hypotheses about the causal relationships between all variables in a Directed Acyclic Graph  and used the DAG to determine the minimum variables necessary to include in multivariable analyses to remove confounding of the main effects. Our primary hypothesis is that men's and women's attitudes about IPV, relationship power, and sexual decision making (including couple concordance/discordance on these attitudes) are proximate determinants of women's experience of IPV. Specifically, we proposed that women's and men's espousal of inequitable gender attitudes would be associated with greater experience of IPV at baseline and over time. We also hypothesized that couples' discordance on these issues would be associated with a heightened risk of IPV at baseline, and that this relationship would persist over time. We further hypothesized that the very fact of discordance between couples is more important than the nature of that discordance; that is, we proposed that lack of agreement between a woman and her partner (regardless of which partner held the more inequitable attitudes) would be associated with a higher risk of IPV than if she agreed with her partner. This finding would be consistent with earlier studies that have found that women themselves often exhibit highly inequitable attitudes about IPV as a way of fitting in with their communities and protecting themselves from violence , 25. Study protocols were approved by institutional review boards in Tanzania and the United States. All study participants gave written informed consent to participate in the study. Couples were interviewed separately at a study station that was set up on the outskirts of the village, and care was taken to ensure privacy and confidentiality. Study interviewers received in-depth training on interviewing techniques, gender and reproductive health, and the study protocols. A study liaison was identified in each village to help participants gain access to further information, counseling services, and study personnel. In addition, study counselors received training on how to offer psychosocial support and were equipped with information on domestic violence-related services.The outcome of interest\u2014women's self-report of intimate partner violence over the previous 4-month period\u2014was measured using a dichotomous variable based on four questions from the RESPECT questionnaire: \u201chave you been hit, kicked, or beaten by your partner and/or a family member for any reason during the last 4 months?\u201d, \u201cHas your partner or another family member done any of the following during the last 4 months: humiliated you in front of others, insulted you, tried to scare you, threatened to hurt you or someone you care about?\u201d, \u201cHave you been physically forced to have sexual intercourse when you did not want to during the last 4 months?\u201d, and \u201cDid you, during the last 4 months, have sexual intercourse when you did not want to because you were afraid of what your partner might do?\u201d. Participants who responded \u201cyes\u201d to one or more of these questions were coded as having experienced violence, while those who responded \u201cno\u201d to all four questions were coded as not having experienced violence. The RESPECT questionnaire did not ask women about lifetime experience of violence; at all rounds, women were asked about their experience of violence in the previous four months. Although the RESPECT questionnaire asked similar questions regarding male participants' perpetration of violence against their partners, couples did not always agree on violence within their relationships (data not shown). Given this disagreement and our primary interest in examining women's experience of IPV during the course of the study, we decided to focus on women's report of violence as the outcome measure. Our analyses focused on the association between women's reports of IPV and women's and men's attitudes about IPV, relationship power, and sexual decision making and couples' concordance. Men's and women's attitudes towards IPV and opinions about power within relationships were assessed using four exposure variables. The first question (\u201cis a husband justified in beating his wife if\u2026\u201d) measured the acceptability of physical IPV in five hypothetical situations: if a wife goes out without telling her husband, if she neglects the children, if she argues with her husband, if she refuses to have sex with her husband, or if she burns the food. A binary variable was created to measure acceptability of IPV, coded as \u201c1\u201d if a participant responded in the affirmative to any of these five situations and coded as \u201c0\u201d if the participant did not agree that violence was justified in any of these situations. The second question assessed the acceptability of IPV as a response to a wife refusing to have sex with her husband: \u201cif a woman refuses to have sex with her husband when he wants her to, he has the right to: get angry and reprimand her, refuse to give her money or other means of financial support, use force and have sex with her even if she doesn't want to, or go and have sex with another woman.\u201d A binary variable (yes/no) was created on the basis of whether participants thought IPV was acceptable in response to a wife's refusal to have sex. For each of these questions, couples were coded as having concordant responses if both partners shared the same binary response.Our third and fourth exposure variables of interest assessed participants' opinions about power within their relationship. These were ascertained using the following two questions: \u201cwho usually has more say about whether you have sex?\u201d and \u201cin general, who do you think has more power in your relationship?\u201d Participants were given the response options \u201cmyself\u201d, \u201cmy partner\u201d, or \u201cboth people equally.\u201d Couples were determined to be concordant if they shared the same response about which partner had more to say about having sex or had more power in the relationship, regardless of which partner this was or whether they agreed that they shared these decisions equally. Other covariables we considered included age (measured as a continuous variable), education status , and socioeconomic position . We also examined differences in reported IPV by study arm.Analyses were conducted using data from the subset of heterosexual couples who were enrolled in the study together. All couples were included in the baseline data analysis, and couples on whom data were available for a minimum of two out of the four rounds were included in the longitudinal analyses. For each round, couples were included in the analysis as long as there were no missing data on the variables of interest. t-tests. Next, we looked at changes in women's reports of IPV as well as changes in participant's attitudes about IPV and relationship power during the follow-up period. We conducted tests for trend to determine whether changes were statistically significant. Preliminary analyses focused on the cross-sectional relationships between age, education, and socioeconomic position and ever having experienced IPV at baseline using contingency tables, Chi-square analyses, and Student's To examine the independent relationship between the exposure variables (women's and men's attitudes towards IPV and relationship power and partner concordance on attitudes) and IPV, we fit separate logistic regression models for each indicator. We also ran a multivariable logistic regression model to examine the association of each main exposure variable and IPV, adjusting for socioeconomic status, age, and education. Finally, to examine the longitudinal relationship between the exposure variables of interest and women's experience of IPV, we used multivariable random effects logistic regression models . These mSocioeconomic position, age, education, and round of data collection were included in the models as confounders. Interactions between these confounders and the exposures of interest were also considered. However because they were not statistically significant, they were not included in the final model. We examined three \u201cfamilies\u201d of hypotheses: based on women's attitudes and opinions, men's attitudes and opinions, and couple concordance. We believed that an individual hypothesis within each family would have to be considered in light of the additional tests performed on other hypotheses within the subgroup. Since each family of hypotheses included four exposure variables, we determined that an appropriate significance level  for each hypothesis test would be set at 0.05/4 or 0.0125. Out of a total of 2,399 individuals enrolled in RESPECT, 567 couples were identified and included in this analysis. A comparison of individuals who reported being married or living together as married and who did not enroll as a couple and those who did enroll as a couple indicated that there were no statistically significant demographic differences between the two groups. A total of 26 couples were lost to follow up: seven after the baseline round and an additional 19 between rounds 2 and 4. Additionally, at each round, between two and four couples were missing data on one or more variables and were excluded from the analysis. Couples who were lost to follow or excluded due to missing data did not differ in terms of demographic characteristics or women's reports of IPV (data not shown). Participant characteristics at baseline including demographic background, experiences of IPV, attitudes about violence and opinions about sexual decision making and relationship power are shown in P < 0.0005) and was not associated with demographic characteristics or study arm. In addition, at 12 months, fewer women and men noted that violence against a wife was acceptable, and a larger proportion of participants reported that sexual decision making was shared by both partners  decreased steadily over time from 20.5% at baseline to 11.8% at 12 months (data not shown). The decrease was statistically significant . This longitudinal analysis suggests that couples' attitudes towards violence and opinions about sexual decision making and relationship power are proximate determinants of women's experience of IPV. The study also provides some evidence that discordance among couples on these issues may heighten women's risk of experiencing IPV. Our observation that gender inequitable attitudes were more commonly reported by women than men is consistent with findings from other studies . It is pIt is encouraging to note that men and women tended to express more gender equitable attitudes by the end of the study. The fact that attitudes about the acceptability of IPV changed far more than opinions about sexual decision making and power within participants' relationships suggests that the changes could have been partly a result of social desirability bias. However, reported 1PV declined steadily over the course of the study from 20% at baseline to 12% at the end of one year of followup, and were not associated with demographic characteristics or intervention/control status. Since we have data on levels of IPV only from RESPECT study participants, we cannot determine whether this result reflects a declining trend in IPV in this region. However, to our knowledge, no major interventions on IPV occurred during this time period and it is unlikely that such a substantial reduction in IPV could be explained in this fashion. The reduction in women's reports of IPV\u2014despite improved rapport between participants and study staff (which may have improved IPV disclosure)\u2014suggests that changes in men's attitudes and behaviors may have resulted from study participation. Given that the proportion of individuals who participated in the group counseling sessions on relationship and life skills was low (data not shown), and that STI/HIV counseling did not explicitly address relationship issues, we hypothesize that repeated exposure to survey questions on relationship dynamics and the opportunity to participate in the study as a couple may have contributed to these shifts. Engaging men and women\u2014as individuals, couples, and community members\u2014is widely accepted as an important component of IPV prevention efforts worldwide , 29. At Results of the longitudinal regression analyses point to the potential benefits of promoting notions of equity in relationships. Women who reported that they shared sexual decision making and relationship power with their partner were consistently less likely to report IPV. In contrast, IPV was reported more frequently when men and women espoused inequitable attitudes or reported that women had more decision making control in the relationship although few of these associations were statistically significant. These findings underscore the need to better understand the delicate balance of power in intimate relationships and the role that perceived or actual imbalances in power  have in heightening women's risk of IPV. Further qualitative research may shed light on the dynamics of power, conflict, and violence within relationships in which partners hold similar or differing views.The association between couples' concordance on attitudes about IPV and relationship power and women's experience of violence also merits further investigation. Our study had limited statistical power to investigate the relationship between different types of concordance/discordance and IPV risk. Thus, we were unable to examine whether IPV risk differed depending on who held more equitable attitudes within a relationship. For example, future research should explore whether risk is higher among women who feel IPV is unjustified and whose partners feel it is justified. Previous research has suggested that discordance within a couple arising from perceived or actual gains in power by women can result in backlash, including IPV by men , 29, 30.Overall, much remains to be learned about how women and men perceive and engage with ideas of greater equity in intimate relationships. Gender norms and values are dynamic, and their relationship with individual behaviors and experiences is complex. Further in-depth examination of young women's and men's evolving ideas about gender, identity, and relationships is needed. Several questions merit study. For example, do young men and women perceive their relationship to be \u201chealthy\u201d? Do they desire greater equity and how do they define equity in a relationship? Are these views\u2014and concordance/discordance in views within a couple\u2014associated with how partners communicate with each other, handle conflicts, and experience or perpetrate IPV? A better understanding of these questions will further illuminate the ways in which gender norms and relationship dynamics influence women's risk of experiencing of violence and help identify entry points for IPV prevention efforts.Our study has additional limitations. First, the decision to measure IPV as a binary variable without accounting for frequency or type of IPV, while providing us with more statistical power, may have prevented us from observing crucial differences in the associations between attitudes and IPV risk. Second, it is especially difficult to draw strong conclusions about the heightened risk of IPV among couples holding discordant attitudes without a finer understanding of how the composition of this discordance might differently impact women's experience of IPV. Third, the decision to use only partnered couples in these analyses also raises issues of potential selection bias. It is possible that partners who both chose to participate in the RESPECT study differed in important ways from participants whose partners chose not to be in the study, including on attitudes about the acceptability of IPV. Finally, it is possible that women who experience IPV are more likely to report that violence is justified. Despite its limitations, this research provides some new insights on the role of women's and men's attitudes toward IPV and relationship power, including the role of partner discordance, in influencing women's experience of IPV. Unlike most previous research in Tanzania, this study prospectively examined the relationship between attitudes about gender relations and IPV among young couples. The widespread acceptance of IPV and inequitable power within relationships in this population highlights the urgent need for programs that help young people acknowledge, understand and challenge gender-based hierarchies. Greater understanding of young people's perceptions of \u201cgender equity\u201d\u2014by focusing on women and men who do not condone IPV and who share power within their relationship\u2014will facilitate the development of antiviolence programs. Furthermore, couple-based programs for HIV testing and treatment have been successful in sub-Saharan Africa and offer a foundation for antiviolence efforts . The dec", "texts": ["Intimate partner violence (IPV) is widely prevalent in Tanzania. Inequitable gender norms manifest in men's and women's attitudes about power and decision making in intimate relationships and are likely to play an important role in determining the prevalence of IPV. We used data from the RESPECT study, a randomized controlled trial that evaluated an intervention to prevent sexually transmitted infections in a cohort of young Tanzanian men and women, to examine the relationship between couples' attitudes about IPV, relationship power, and sexual decision making, concordance on these issues, and women's reports of IPV over 12 months. Women expressed less equitable attitudes than men at baseline. Over time, participants' attitudes tended to become more equitable and women's reports of IPV declined substantially. Multivariable logistic regression analyses suggested that inequitable attitudes and couple discordance were associated with higher risk of IPV. Our findings point to the need for a better understanding of the role that perceived or actual imbalances in relationship power have in heightening IPV risk. The decline in women's reports of IPV and the trend towards gender-equitable attitudes indicate that concerted efforts to reduce IPV and promote gender equity have the potential to make a positive difference in the relatively short term. Intimate partner violence (IPV) is a major public health and human rights concern in Tanzania . AccordiIt is widely accepted that gender inequities, perpetuated by cultural norms regarding gender roles and manifest in men's and women's ideas about power and decision making in relationships, have a profound impact on the perpetration and experience of IPV . SeveralSurvey data lend support to the observation that both men and women in Tanzania condone IPV as a normal part of an intimate relationship , 13. AccAlthough research has explored men's and women's attitudes about IPV, few studies have empirically examined the association between these attitudes and IPV risk . For exaTo our knowledge, the association between couples' attitudes towards IPV, couple concordance in attitudes and IPV risk has not been examined in Tanzania. Using data from the Rewarding STI Prevention and Control in Tanzania (RESPECT) study, we examined men's and women's attitudes about IPV, relationship power, and sexual decision making and couples' concordance on these issues, and whether these attitudes were associated with women's experience of IPV at baseline and over time. The year-long RESPECT study was a randomized controlled trial designed to evaluate whether conditional cash transfers (CCT) promoted safe sex and reduced the incidence of sexually transmitted infections (STIs)  and perpetration of IPV (men). They also underwent STI and HIV counseling and testing. Participants in the CCT arms received cash payments for every 4 monthly negative STI laboratory test result. All enrolled individuals were invited to group counseling sessions that focused on relationship and life skills training based on the Stepping Stones curriculum . The analysis is guided by a social-ecological framework, which posits that IPV risk is shaped by the interplay of a host of individual, community, and societal factors, including individual beliefs and practices within an intimate relationship as well as community and societal norms regarding gender and power . It is aIn this analysis, we considered attitudes toward IPV as proximate determinants, and gender norms as a key underlying, distal determinant of IPV. For example, women's access to education and employment is limited in social and cultural environments that are highly patriarchal, increasing their economic dependence on male partners, which is a known risk factor for IPV  . SimilarWe outlined our hypotheses about the causal relationships between all variables in a Directed Acyclic Graph  and used the DAG to determine the minimum variables necessary to include in multivariable analyses to remove confounding of the main effects. Our primary hypothesis is that men's and women's attitudes about IPV, relationship power, and sexual decision making (including couple concordance/discordance on these attitudes) are proximate determinants of women's experience of IPV. Specifically, we proposed that women's and men's espousal of inequitable gender attitudes would be associated with greater experience of IPV at baseline and over time. We also hypothesized that couples' discordance on these issues would be associated with a heightened risk of IPV at baseline, and that this relationship would persist over time. We further hypothesized that the very fact of discordance between couples is more important than the nature of that discordance; that is, we proposed that lack of agreement between a woman and her partner (regardless of which partner held the more inequitable attitudes) would be associated with a higher risk of IPV than if she agreed with her partner. This finding would be consistent with earlier studies that have found that women themselves often exhibit highly inequitable attitudes about IPV as a way of fitting in with their communities and protecting themselves from violence , 25. Study protocols were approved by institutional review boards in Tanzania and the United States. All study participants gave written informed consent to participate in the study. Couples were interviewed separately at a study station that was set up on the outskirts of the village, and care was taken to ensure privacy and confidentiality. Study interviewers received in-depth training on interviewing techniques, gender and reproductive health, and the study protocols. A study liaison was identified in each village to help participants gain access to further information, counseling services, and study personnel. In addition, study counselors received training on how to offer psychosocial support and were equipped with information on domestic violence-related services.The outcome of interest\u2014women's self-report of intimate partner violence over the previous 4-month period\u2014was measured using a dichotomous variable based on four questions from the RESPECT questionnaire: \u201chave you been hit, kicked, or beaten by your partner and/or a family member for any reason during the last 4 months?\u201d, \u201cHas your partner or another family member done any of the following during the last 4 months: humiliated you in front of others, insulted you, tried to scare you, threatened to hurt you or someone you care about?\u201d, \u201cHave you been physically forced to have sexual intercourse when you did not want to during the last 4 months?\u201d, and \u201cDid you, during the last 4 months, have sexual intercourse when you did not want to because you were afraid of what your partner might do?\u201d. Participants who responded \u201cyes\u201d to one or more of these questions were coded as having experienced violence, while those who responded \u201cno\u201d to all four questions were coded as not having experienced violence. The RESPECT questionnaire did not ask women about lifetime experience of violence; at all rounds, women were asked about their experience of violence in the previous four months. Although the RESPECT questionnaire asked similar questions regarding male participants' perpetration of violence against their partners, couples did not always agree on violence within their relationships (data not shown). Given this disagreement and our primary interest in examining women's experience of IPV during the course of the study, we decided to focus on women's report of violence as the outcome measure. Our analyses focused on the association between women's reports of IPV and women's and men's attitudes about IPV, relationship power, and sexual decision making and couples' concordance. Men's and women's attitudes towards IPV and opinions about power within relationships were assessed using four exposure variables. The first question (\u201cis a husband justified in beating his wife if\u2026\u201d) measured the acceptability of physical IPV in five hypothetical situations: if a wife goes out without telling her husband, if she neglects the children, if she argues with her husband, if she refuses to have sex with her husband, or if she burns the food. A binary variable was created to measure acceptability of IPV, coded as \u201c1\u201d if a participant responded in the affirmative to any of these five situations and coded as \u201c0\u201d if the participant did not agree that violence was justified in any of these situations. The second question assessed the acceptability of IPV as a response to a wife refusing to have sex with her husband: \u201cif a woman refuses to have sex with her husband when he wants her to, he has the right to: get angry and reprimand her, refuse to give her money or other means of financial support, use force and have sex with her even if she doesn't want to, or go and have sex with another woman.\u201d A binary variable (yes/no) was created on the basis of whether participants thought IPV was acceptable in response to a wife's refusal to have sex. For each of these questions, couples were coded as having concordant responses if both partners shared the same binary response.Our third and fourth exposure variables of interest assessed participants' opinions about power within their relationship. These were ascertained using the following two questions: \u201cwho usually has more say about whether you have sex?\u201d and \u201cin general, who do you think has more power in your relationship?\u201d Participants were given the response options \u201cmyself\u201d, \u201cmy partner\u201d, or \u201cboth people equally.\u201d Couples were determined to be concordant if they shared the same response about which partner had more to say about having sex or had more power in the relationship, regardless of which partner this was or whether they agreed that they shared these decisions equally. Other covariables we considered included age (measured as a continuous variable), education status , and socioeconomic position . We also examined differences in reported IPV by study arm.Analyses were conducted using data from the subset of heterosexual couples who were enrolled in the study together. All couples were included in the baseline data analysis, and couples on whom data were available for a minimum of two out of the four rounds were included in the longitudinal analyses. For each round, couples were included in the analysis as long as there were no missing data on the variables of interest. t-tests. Next, we looked at changes in women's reports of IPV as well as changes in participant's attitudes about IPV and relationship power during the follow-up period. We conducted tests for trend to determine whether changes were statistically significant. Preliminary analyses focused on the cross-sectional relationships between age, education, and socioeconomic position and ever having experienced IPV at baseline using contingency tables, Chi-square analyses, and Student's To examine the independent relationship between the exposure variables (women's and men's attitudes towards IPV and relationship power and partner concordance on attitudes) and IPV, we fit separate logistic regression models for each indicator. We also ran a multivariable logistic regression model to examine the association of each main exposure variable and IPV, adjusting for socioeconomic status, age, and education. Finally, to examine the longitudinal relationship between the exposure variables of interest and women's experience of IPV, we used multivariable random effects logistic regression models . These mSocioeconomic position, age, education, and round of data collection were included in the models as confounders. Interactions between these confounders and the exposures of interest were also considered. However because they were not statistically significant, they were not included in the final model. We examined three \u201cfamilies\u201d of hypotheses: based on women's attitudes and opinions, men's attitudes and opinions, and couple concordance. We believed that an individual hypothesis within each family would have to be considered in light of the additional tests performed on other hypotheses within the subgroup. Since each family of hypotheses included four exposure variables, we determined that an appropriate significance level  for each hypothesis test would be set at 0.05/4 or 0.0125. Out of a total of 2,399 individuals enrolled in RESPECT, 567 couples were identified and included in this analysis. A comparison of individuals who reported being married or living together as married and who did not enroll as a couple and those who did enroll as a couple indicated that there were no statistically significant demographic differences between the two groups. A total of 26 couples were lost to follow up: seven after the baseline round and an additional 19 between rounds 2 and 4. Additionally, at each round, between two and four couples were missing data on one or more variables and were excluded from the analysis. Couples who were lost to follow or excluded due to missing data did not differ in terms of demographic characteristics or women's reports of IPV (data not shown). Participant characteristics at baseline including demographic background, experiences of IPV, attitudes about violence and opinions about sexual decision making and relationship power are shown in P < 0.0005) and was not associated with demographic characteristics or study arm. In addition, at 12 months, fewer women and men noted that violence against a wife was acceptable, and a larger proportion of participants reported that sexual decision making was shared by both partners  decreased steadily over time from 20.5% at baseline to 11.8% at 12 months (data not shown). The decrease was statistically significant . This longitudinal analysis suggests that couples' attitudes towards violence and opinions about sexual decision making and relationship power are proximate determinants of women's experience of IPV. The study also provides some evidence that discordance among couples on these issues may heighten women's risk of experiencing IPV. Our observation that gender inequitable attitudes were more commonly reported by women than men is consistent with findings from other studies . It is pIt is encouraging to note that men and women tended to express more gender equitable attitudes by the end of the study. The fact that attitudes about the acceptability of IPV changed far more than opinions about sexual decision making and power within participants' relationships suggests that the changes could have been partly a result of social desirability bias. However, reported 1PV declined steadily over the course of the study from 20% at baseline to 12% at the end of one year of followup, and were not associated with demographic characteristics or intervention/control status. Since we have data on levels of IPV only from RESPECT study participants, we cannot determine whether this result reflects a declining trend in IPV in this region. However, to our knowledge, no major interventions on IPV occurred during this time period and it is unlikely that such a substantial reduction in IPV could be explained in this fashion. The reduction in women's reports of IPV\u2014despite improved rapport between participants and study staff (which may have improved IPV disclosure)\u2014suggests that changes in men's attitudes and behaviors may have resulted from study participation. Given that the proportion of individuals who participated in the group counseling sessions on relationship and life skills was low (data not shown), and that STI/HIV counseling did not explicitly address relationship issues, we hypothesize that repeated exposure to survey questions on relationship dynamics and the opportunity to participate in the study as a couple may have contributed to these shifts. Engaging men and women\u2014as individuals, couples, and community members\u2014is widely accepted as an important component of IPV prevention efforts worldwide , 29. At Results of the longitudinal regression analyses point to the potential benefits of promoting notions of equity in relationships. Women who reported that they shared sexual decision making and relationship power with their partner were consistently less likely to report IPV. In contrast, IPV was reported more frequently when men and women espoused inequitable attitudes or reported that women had more decision making control in the relationship although few of these associations were statistically significant. These findings underscore the need to better understand the delicate balance of power in intimate relationships and the role that perceived or actual imbalances in power  have in heightening women's risk of IPV. Further qualitative research may shed light on the dynamics of power, conflict, and violence within relationships in which partners hold similar or differing views.The association between couples' concordance on attitudes about IPV and relationship power and women's experience of violence also merits further investigation. Our study had limited statistical power to investigate the relationship between different types of concordance/discordance and IPV risk. Thus, we were unable to examine whether IPV risk differed depending on who held more equitable attitudes within a relationship. For example, future research should explore whether risk is higher among women who feel IPV is unjustified and whose partners feel it is justified. Previous research has suggested that discordance within a couple arising from perceived or actual gains in power by women can result in backlash, including IPV by men , 29, 30.Overall, much remains to be learned about how women and men perceive and engage with ideas of greater equity in intimate relationships. Gender norms and values are dynamic, and their relationship with individual behaviors and experiences is complex. Further in-depth examination of young women's and men's evolving ideas about gender, identity, and relationships is needed. Several questions merit study. For example, do young men and women perceive their relationship to be \u201chealthy\u201d? Do they desire greater equity and how do they define equity in a relationship? Are these views\u2014and concordance/discordance in views within a couple\u2014associated with how partners communicate with each other, handle conflicts, and experience or perpetrate IPV? A better understanding of these questions will further illuminate the ways in which gender norms and relationship dynamics influence women's risk of experiencing of violence and help identify entry points for IPV prevention efforts.Our study has additional limitations. First, the decision to measure IPV as a binary variable without accounting for frequency or type of IPV, while providing us with more statistical power, may have prevented us from observing crucial differences in the associations between attitudes and IPV risk. Second, it is especially difficult to draw strong conclusions about the heightened risk of IPV among couples holding discordant attitudes without a finer understanding of how the composition of this discordance might differently impact women's experience of IPV. Third, the decision to use only partnered couples in these analyses also raises issues of potential selection bias. It is possible that partners who both chose to participate in the RESPECT study differed in important ways from participants whose partners chose not to be in the study, including on attitudes about the acceptability of IPV. Finally, it is possible that women who experience IPV are more likely to report that violence is justified. Despite its limitations, this research provides some new insights on the role of women's and men's attitudes toward IPV and relationship power, including the role of partner discordance, in influencing women's experience of IPV. Unlike most previous research in Tanzania, this study prospectively examined the relationship between attitudes about gender relations and IPV among young couples. The widespread acceptance of IPV and inequitable power within relationships in this population highlights the urgent need for programs that help young people acknowledge, understand and challenge gender-based hierarchies. Greater understanding of young people's perceptions of \u201cgender equity\u201d\u2014by focusing on women and men who do not condone IPV and who share power within their relationship\u2014will facilitate the development of antiviolence programs. Furthermore, couple-based programs for HIV testing and treatment have been successful in sub-Saharan Africa and offer a foundation for antiviolence efforts . The dec"]}
{"representative": "Intimate partner violence (IPV) is associated with increased risk of HIV among women globally. There is limited evidence and understanding about IPV and potential HIV risk pathways among sex workers (SWs). This study aims to longitudinally evaluate prevalence and correlates of IPV among street and off-street SWs over two-years follow-up.Longitudinal data were drawn from an open prospective cohort, AESHA  in Metro Vancouver, Canada (2010\u20132012). Prevalence of physical and sexual IPV was measured using the WHO standardized IPV scale (version 9.9). Bivariate and multivariable logistic regression using Generalized Estimating Equations (GEE) were used to examine interpersonal and structural correlates of IPV over two years., 387 SWs had a male, intimate sexual partner and were eligible for this analysis. One-fifth  experienced recent physical/sexual IPV at baseline and 26.2% over two-years follow-up. In multivariable GEE analysis, factors independently correlated with physical/sexual IPV in the last six months include: childhood (<18 years) sexual/physical abuse , inconsistent condom use for vaginal and/or anal sex with intimate partner , <daily prescription opioid use , providing financial support to intimate partner , and sourcing drugs from intimate partner .At baselineOur results demonstrate that over one-fifth of SWs in Vancouver report physical/sexual IPV in the last six months. The socio-structural correlates of IPV uncovered here highlight potential HIV risk pathways through SWs\u2019 intimate, non-commercial partner relationships. The high prevalence of IPV among SWs is a critical public health concern and underscores the need for integrated violence and HIV prevention and intervention strategies tailored to this key population. Male-perpetrated intimate partner violence (IPV) is a pervasive human rights violation and public health concern, with substantial negative impacts on morbidity and mortality, including poor sexual and reproductive health outcomes, HIV, and sexually transmitted infections (STIs) Immediate consequences of IPV include injuries and death from physical assault, unintended pregnancies, HIV/STIs, and psychological distress In North America, male-perpetrated IPV is associated with a significant burden. In the U.S., the 2010 National Intimate Partner and Sexual Violence Survey indicated that 30% of women experience physical IPV and 17% sexual IPV in their lifetimes Other studies from around the world have documented the association between partner violence and gender inequality with increased risk of HIV Despite growing data on the magnitude and correlates of IPV among the general population of women of reproductive age globally Qualitative and ethnographic research among marginalized groups of women  has documented the pervasiveness of controlling and abusive boyfriends, providing some contextual understanding around the power imbalances and associated violence that directly influences women\u2019s agency and ability to safeguard against risky sexual and drug-using behaviors, making these populations particularly vulnerable to transmission of HIV/STIs There is a critical need for research on IPV among marginalized groups, including SWs. The objectives of this study were therefore to examine the prevalence of physical and sexual IPV against a cohort of SWs in Vancouver, Canada and to describe the socio-structural correlates of IPV.Data for this study were drawn from AESHA , an open prospective cohort of female SWs (2010\u20132012) who conduct sex work in both street (public) and off-street (indoor) settings. Eligibility criteria for AESHA participants at baseline includes being female , older than 14 years of age, having exchanged sex for money within the last 30 days, and providing written informed consent. This analysis is restricted to AESHA participants who reported having at least one intimate partner, which is defined as having a sexual, non-commercial, male partner in the last six months, at baseline.In the context of hard-to-reach populations, SWs were recruited through time-location sampling and community mapping strategies. Day and late night peer-outreach was used to identify both outdoor sex work locations  and indoor sex work venues  across Metro Vancouver. In addition, online recruitment was used to reach SWs working through online solicitations spaces.At enrolment and on a bi-annual basis, participants complete an interview-administered questionnaire by a trained interviewer and HIV/STI/HCV (hepatitis C virus) serology testing by a project nurse. The main interview questionnaire elicits responses related to socio-demographics , sex industry work , clients , intimate partners , trauma and violence , and drug use patterns (injection and non-injection). In addition, a clinical questionnaire is administered relating to overall physical, mental and emotional health, sexual and reproductive health, and HIV testing and treatment experiences. SWs have the option to visit one of two study offices or complete the questionnaire and nursing component at a safe location identified by them, including work or home locations. All participants receive an honorarium of $40CAD at each bi-annual visit for their time, expertise and travel.The AESHA study holds ethical approval through Providence Health Care/University of British Columbia Research Ethics Board and has a community advisory board of over 15 agencies.Recent IPV was measured using an abridged version of the WHO Standardized IPV Scale Version 9.9 Study variables for potential correlates of IPV were selected based on the literature and available data collected for the AESHA cohort between 2010 and 2012. Fixed variables considered at baseline included demographic variables such as: age (continuous), sexual minority , being of Aboriginal/Indigenous ancestry , and being a migrant/new immigrant worker (versus Canadian born). Historical exposure to childhood physical and/or sexual abuse (<18 years of age) was also included. Individual variables including frequency of use of injection and non-injection illicit drugs  were time-updated, and based on the last six months at each follow-up.The study participants provided all information relating to their partners, as the partners themselves were not interviewed. Partner-level data were time-updated, co-variates were collected at baseline and each follow-up visit for the primary intimate sex partner, and included inconsistent condom use for vaginal/anal sex with intimate partners, condom refusal by intimate partner, cohabitating with intimate partner, sourcing drugs  from intimate partner, and financial support provided to or by an intimate partner. Whether or not intimate partners had other sexual partners  was also included.Analyses were restricted to AESHA participants who reported having at least one recent intimate  male sex partner (last six months). Socio-demographic variables  were considered fixed variables. All other variables were considered time varying, and were updated to reflect their occurrence within the last six months. All time-updated variables were measured at the same time period as the outcome. Correlates of IPV were examined using bivariate and multivariable logistic regression using Generalized Estimating Equations (GEE), with a logit link for dichotomous variables. To adjust the standard error and account for correlations arising from the four repeated measurements on the same participant over the two-years follow-up period, an exchangeable correlation matrix was used. GEE accounts for missing data using the GEE estimating equation, that substitutes data from non-missing pairs into the estimators of the correlations matrix. Variables significantly associated with IPV at the p<0.05 level in bivariate screening were subsequently fitted into a multivariable GEE model to adjust for potential confounding. The multivariable model was constructed using Quasi-likelihood Information Criteria (QIC) selection, which has been used successfully in past research by our group Of the total cohort (n\u200a=\u200a652), our analyses were restricted to participants who reported having at least one male, intimate sexual partner in the past six months for a sample of 387 street and off-street SWs. At baseline, one-fifth  of women reported experiencing moderate or severe physical and/or sexual IPV in the last six months. The median age of all participants was 34 , with those who reported recent IPV being slightly younger than those who did not: 32 (IQR: 25\u201339) vs. 35 (IQR: 28\u201342) (p\u200a=\u200a0.003). Most women (76.2%) were Canadian-born, and 39.0% self-identified as being of Aboriginal ancestry. Almost one quarter (24.3%) of participants reported being a sexual minority. The majority (66.7%) of SWs reported physical and/or sexual abuse before age 18 and this was higher among those who had experienced recent IPV compared to those who had not (84.3% vs. 61.8%) (p<0.001). Baseline socio-demographic and partner-level characteristics of participants who experienced IPV in the last six months compared to those who did not are displayed in Regarding drug use, 72.1% of SWs at baseline had used non-injection illicit drugs and 40.8% had injected drugs in the last six months. At baseline, the number of SWs who reported using prescription opioids (POs) less than daily was 63 (16.3%), which was higher among those with IPV (28.9%) than those without (12.8%) (p\u200a=\u200a0.003). Non-injection and injection drug use by intimate partners was reported at 63.6% and 21.2%, respectively, and 37.5% of participants reported sourcing drugs from their intimate partners. In the last six months, 39.0% of SWs were living with their intimate partners and 13.7% of intimate partners had other sex partners.Bivariate and multivariable odds ratios for correlates with recent IPV are displayed in In the multivariable GEE analysis, factors independently correlated with recent physical/sexual IPV over the last six months include: childhood physical and/or sexual abuse <18 years , inconsistent condom use for vaginal and/or anal sex with intimate partner , less than daily PO use , providing financial support to intimate partner , sourcing drugs from intimate partner  and younger age .Our longitudinal study demonstrates that over one-fifth of SWs in Metro Vancouver report moderate or severe physical and/or sexual IPV in the last six months. Experiencing recent IPV was independently associated with early childhood exposure to physical and/or sexual abuse, while partner-level factors emerged as key correlates over the course of follow-up, including inconsistent condom use, economic dependence of male intimate partner on sex worker, and sourcing drugs from an intimate partner.The high prevalence of recent IPV among street and off-street SWs in our study is a critical and neglected human rights and public health concern and underscores the pressing need to focus on marginalized and hidden populations. Our results support existing literature documenting elevated levels of violence faced by SWs in Vancouver The overlap between gender inequality and heightened risk of HIV plays an important role in the context of IPV against SWs. It is estimated that SWs have more than 13-times increased odds of having HIV compared to the general female population Among drug-using women in particular, power dynamics with their intimate partners often favour traditional gender roles where men exert significant control over the relationship, including negotiating sexual risk-reduction behaviours. Bi-directional temporal relationships between sexual and physical IPV and risk of HIV/STI transmission have been demonstrated among drug-using women in the U.S, where inconsistent/no condom use and requesting partners to use condoms was significantly associated with IPV Qualitative research among substance-using women in survival sex work underscores the role of structural violence and gendered power inequities in shaping HIV and the need to facilitate enabling environments This study\u2019s findings that childhood abuse is positively associated with recent IPV, often referred to as \u201cre-victimization\u201d, is consistently documented in many settings Although violence between partners occurs at the interpersonal-level, the larger macro-level context plays an important role in sustaining cultures of complacency that tolerate gender-based violence, including against SWs. The criminalized nature of the sex industry in Canada drives a culture of stigma among SWs that leads to a cycle of violence that is ultimately fuelled by power inequity. Laws that further marginalize SWs not only constrain their choices occupationally, but also undermine their health in general: stigma associated with sex work prevents SWs from accessing health care services needed for violence treatment and prevention Implementing screening instruments for IPV in reproductive/primary health care and low-threshold support settings for marginalized populations, may help to more accurately detect IPV and direct focus toward SWs\u2019 often overlooked non-commercial relationships. However, there continues to be debate around the extent to which screening effectively improves health outcomes for women This study has a number of strengths and limitations that should be considered in the interpretation of our study. The longitudinal design and analytic methods (GEE) are considered strengths of this study, increasing the number of observations, and allowing for average estimates of the correlates of IPV over a two-year period. However, as our analyses did not allow for temporal associations, we were unable to determine causality between the study variables and IPV. Many of the variables examined in our study were sensitive  and IPV is a highly stigmatizing topic, which may have resulted in under-reporting or respondent-driven reporting biases in violence by our participants. However, the WHO Standardized IPV Scale used in this study was designed to ask a limited number of questions pertaining to common acts in violent partnerships rather than requiring respondents to identify themselves as abused \u2013 an approach that has been shown to encourage greater disclosure of violence The magnitude of physical and/or sexual IPV reported by SWs in our study demonstrates a critical need to focus on marginalized and stigmatized SW populations. SWs remain entrenched in a cycle of violence that often started in childhood and continues to impact their current intimate relationships. Our findings highlight key factors associated with IPV, including childhood exposure to physical or sexual violence, inconsistent condom use with intimate partners, economic dependence and sourcing drugs from an intimate partner, as well as PO use among SWs. The correlates of IPV uncovered here highlight important socio-structural factors that intersect with violence within SWs\u2019 intimate, non-commercial partner relationships and underscore the need for further prevention and intervention strategies tailored to this key population, who continue to experience a disproportionate burden of violence.", "texts": ["Intimate partner violence (IPV) is associated with increased risk of HIV among women globally. There is limited evidence and understanding about IPV and potential HIV risk pathways among sex workers (SWs). This study aims to longitudinally evaluate prevalence and correlates of IPV among street and off-street SWs over two-years follow-up.Longitudinal data were drawn from an open prospective cohort, AESHA  in Metro Vancouver, Canada (2010\u20132012). Prevalence of physical and sexual IPV was measured using the WHO standardized IPV scale (version 9.9). Bivariate and multivariable logistic regression using Generalized Estimating Equations (GEE) were used to examine interpersonal and structural correlates of IPV over two years., 387 SWs had a male, intimate sexual partner and were eligible for this analysis. One-fifth  experienced recent physical/sexual IPV at baseline and 26.2% over two-years follow-up. In multivariable GEE analysis, factors independently correlated with physical/sexual IPV in the last six months include: childhood (<18 years) sexual/physical abuse , inconsistent condom use for vaginal and/or anal sex with intimate partner , <daily prescription opioid use , providing financial support to intimate partner , and sourcing drugs from intimate partner .At baselineOur results demonstrate that over one-fifth of SWs in Vancouver report physical/sexual IPV in the last six months. The socio-structural correlates of IPV uncovered here highlight potential HIV risk pathways through SWs\u2019 intimate, non-commercial partner relationships. The high prevalence of IPV among SWs is a critical public health concern and underscores the need for integrated violence and HIV prevention and intervention strategies tailored to this key population. Male-perpetrated intimate partner violence (IPV) is a pervasive human rights violation and public health concern, with substantial negative impacts on morbidity and mortality, including poor sexual and reproductive health outcomes, HIV, and sexually transmitted infections (STIs) Immediate consequences of IPV include injuries and death from physical assault, unintended pregnancies, HIV/STIs, and psychological distress In North America, male-perpetrated IPV is associated with a significant burden. In the U.S., the 2010 National Intimate Partner and Sexual Violence Survey indicated that 30% of women experience physical IPV and 17% sexual IPV in their lifetimes Other studies from around the world have documented the association between partner violence and gender inequality with increased risk of HIV Despite growing data on the magnitude and correlates of IPV among the general population of women of reproductive age globally Qualitative and ethnographic research among marginalized groups of women  has documented the pervasiveness of controlling and abusive boyfriends, providing some contextual understanding around the power imbalances and associated violence that directly influences women\u2019s agency and ability to safeguard against risky sexual and drug-using behaviors, making these populations particularly vulnerable to transmission of HIV/STIs There is a critical need for research on IPV among marginalized groups, including SWs. The objectives of this study were therefore to examine the prevalence of physical and sexual IPV against a cohort of SWs in Vancouver, Canada and to describe the socio-structural correlates of IPV.Data for this study were drawn from AESHA , an open prospective cohort of female SWs (2010\u20132012) who conduct sex work in both street (public) and off-street (indoor) settings. Eligibility criteria for AESHA participants at baseline includes being female , older than 14 years of age, having exchanged sex for money within the last 30 days, and providing written informed consent. This analysis is restricted to AESHA participants who reported having at least one intimate partner, which is defined as having a sexual, non-commercial, male partner in the last six months, at baseline.In the context of hard-to-reach populations, SWs were recruited through time-location sampling and community mapping strategies. Day and late night peer-outreach was used to identify both outdoor sex work locations  and indoor sex work venues  across Metro Vancouver. In addition, online recruitment was used to reach SWs working through online solicitations spaces.At enrolment and on a bi-annual basis, participants complete an interview-administered questionnaire by a trained interviewer and HIV/STI/HCV (hepatitis C virus) serology testing by a project nurse. The main interview questionnaire elicits responses related to socio-demographics , sex industry work , clients , intimate partners , trauma and violence , and drug use patterns (injection and non-injection). In addition, a clinical questionnaire is administered relating to overall physical, mental and emotional health, sexual and reproductive health, and HIV testing and treatment experiences. SWs have the option to visit one of two study offices or complete the questionnaire and nursing component at a safe location identified by them, including work or home locations. All participants receive an honorarium of $40CAD at each bi-annual visit for their time, expertise and travel.The AESHA study holds ethical approval through Providence Health Care/University of British Columbia Research Ethics Board and has a community advisory board of over 15 agencies.Recent IPV was measured using an abridged version of the WHO Standardized IPV Scale Version 9.9 Study variables for potential correlates of IPV were selected based on the literature and available data collected for the AESHA cohort between 2010 and 2012. Fixed variables considered at baseline included demographic variables such as: age (continuous), sexual minority , being of Aboriginal/Indigenous ancestry , and being a migrant/new immigrant worker (versus Canadian born). Historical exposure to childhood physical and/or sexual abuse (<18 years of age) was also included. Individual variables including frequency of use of injection and non-injection illicit drugs  were time-updated, and based on the last six months at each follow-up.The study participants provided all information relating to their partners, as the partners themselves were not interviewed. Partner-level data were time-updated, co-variates were collected at baseline and each follow-up visit for the primary intimate sex partner, and included inconsistent condom use for vaginal/anal sex with intimate partners, condom refusal by intimate partner, cohabitating with intimate partner, sourcing drugs  from intimate partner, and financial support provided to or by an intimate partner. Whether or not intimate partners had other sexual partners  was also included.Analyses were restricted to AESHA participants who reported having at least one recent intimate  male sex partner (last six months). Socio-demographic variables  were considered fixed variables. All other variables were considered time varying, and were updated to reflect their occurrence within the last six months. All time-updated variables were measured at the same time period as the outcome. Correlates of IPV were examined using bivariate and multivariable logistic regression using Generalized Estimating Equations (GEE), with a logit link for dichotomous variables. To adjust the standard error and account for correlations arising from the four repeated measurements on the same participant over the two-years follow-up period, an exchangeable correlation matrix was used. GEE accounts for missing data using the GEE estimating equation, that substitutes data from non-missing pairs into the estimators of the correlations matrix. Variables significantly associated with IPV at the p<0.05 level in bivariate screening were subsequently fitted into a multivariable GEE model to adjust for potential confounding. The multivariable model was constructed using Quasi-likelihood Information Criteria (QIC) selection, which has been used successfully in past research by our group Of the total cohort (n\u200a=\u200a652), our analyses were restricted to participants who reported having at least one male, intimate sexual partner in the past six months for a sample of 387 street and off-street SWs. At baseline, one-fifth  of women reported experiencing moderate or severe physical and/or sexual IPV in the last six months. The median age of all participants was 34 , with those who reported recent IPV being slightly younger than those who did not: 32 (IQR: 25\u201339) vs. 35 (IQR: 28\u201342) (p\u200a=\u200a0.003). Most women (76.2%) were Canadian-born, and 39.0% self-identified as being of Aboriginal ancestry. Almost one quarter (24.3%) of participants reported being a sexual minority. The majority (66.7%) of SWs reported physical and/or sexual abuse before age 18 and this was higher among those who had experienced recent IPV compared to those who had not (84.3% vs. 61.8%) (p<0.001). Baseline socio-demographic and partner-level characteristics of participants who experienced IPV in the last six months compared to those who did not are displayed in Regarding drug use, 72.1% of SWs at baseline had used non-injection illicit drugs and 40.8% had injected drugs in the last six months. At baseline, the number of SWs who reported using prescription opioids (POs) less than daily was 63 (16.3%), which was higher among those with IPV (28.9%) than those without (12.8%) (p\u200a=\u200a0.003). Non-injection and injection drug use by intimate partners was reported at 63.6% and 21.2%, respectively, and 37.5% of participants reported sourcing drugs from their intimate partners. In the last six months, 39.0% of SWs were living with their intimate partners and 13.7% of intimate partners had other sex partners.Bivariate and multivariable odds ratios for correlates with recent IPV are displayed in In the multivariable GEE analysis, factors independently correlated with recent physical/sexual IPV over the last six months include: childhood physical and/or sexual abuse <18 years , inconsistent condom use for vaginal and/or anal sex with intimate partner , less than daily PO use , providing financial support to intimate partner , sourcing drugs from intimate partner  and younger age .Our longitudinal study demonstrates that over one-fifth of SWs in Metro Vancouver report moderate or severe physical and/or sexual IPV in the last six months. Experiencing recent IPV was independently associated with early childhood exposure to physical and/or sexual abuse, while partner-level factors emerged as key correlates over the course of follow-up, including inconsistent condom use, economic dependence of male intimate partner on sex worker, and sourcing drugs from an intimate partner.The high prevalence of recent IPV among street and off-street SWs in our study is a critical and neglected human rights and public health concern and underscores the pressing need to focus on marginalized and hidden populations. Our results support existing literature documenting elevated levels of violence faced by SWs in Vancouver The overlap between gender inequality and heightened risk of HIV plays an important role in the context of IPV against SWs. It is estimated that SWs have more than 13-times increased odds of having HIV compared to the general female population Among drug-using women in particular, power dynamics with their intimate partners often favour traditional gender roles where men exert significant control over the relationship, including negotiating sexual risk-reduction behaviours. Bi-directional temporal relationships between sexual and physical IPV and risk of HIV/STI transmission have been demonstrated among drug-using women in the U.S, where inconsistent/no condom use and requesting partners to use condoms was significantly associated with IPV Qualitative research among substance-using women in survival sex work underscores the role of structural violence and gendered power inequities in shaping HIV and the need to facilitate enabling environments This study\u2019s findings that childhood abuse is positively associated with recent IPV, often referred to as \u201cre-victimization\u201d, is consistently documented in many settings Although violence between partners occurs at the interpersonal-level, the larger macro-level context plays an important role in sustaining cultures of complacency that tolerate gender-based violence, including against SWs. The criminalized nature of the sex industry in Canada drives a culture of stigma among SWs that leads to a cycle of violence that is ultimately fuelled by power inequity. Laws that further marginalize SWs not only constrain their choices occupationally, but also undermine their health in general: stigma associated with sex work prevents SWs from accessing health care services needed for violence treatment and prevention Implementing screening instruments for IPV in reproductive/primary health care and low-threshold support settings for marginalized populations, may help to more accurately detect IPV and direct focus toward SWs\u2019 often overlooked non-commercial relationships. However, there continues to be debate around the extent to which screening effectively improves health outcomes for women This study has a number of strengths and limitations that should be considered in the interpretation of our study. The longitudinal design and analytic methods (GEE) are considered strengths of this study, increasing the number of observations, and allowing for average estimates of the correlates of IPV over a two-year period. However, as our analyses did not allow for temporal associations, we were unable to determine causality between the study variables and IPV. Many of the variables examined in our study were sensitive  and IPV is a highly stigmatizing topic, which may have resulted in under-reporting or respondent-driven reporting biases in violence by our participants. However, the WHO Standardized IPV Scale used in this study was designed to ask a limited number of questions pertaining to common acts in violent partnerships rather than requiring respondents to identify themselves as abused \u2013 an approach that has been shown to encourage greater disclosure of violence The magnitude of physical and/or sexual IPV reported by SWs in our study demonstrates a critical need to focus on marginalized and stigmatized SW populations. SWs remain entrenched in a cycle of violence that often started in childhood and continues to impact their current intimate relationships. Our findings highlight key factors associated with IPV, including childhood exposure to physical or sexual violence, inconsistent condom use with intimate partners, economic dependence and sourcing drugs from an intimate partner, as well as PO use among SWs. The correlates of IPV uncovered here highlight important socio-structural factors that intersect with violence within SWs\u2019 intimate, non-commercial partner relationships and underscore the need for further prevention and intervention strategies tailored to this key population, who continue to experience a disproportionate burden of violence."]}
{"representative": "In Tanzania like in many sub-Saharan countries the data about Intimate Partner Violence (IPV) are scarce and diverse. This study aims to determine the magnitude of IPV and associated factors among ever partnered women in urban mainland Tanzania.Data for this report were extracted from a big quasi-experimental survey that was used to evaluate MAP (MAP - Men as Partners) project. Data were collected using standard questions as those in big surveys like Demographic and Health Surveys. Data analyses involved descriptive statistics to characterize IPV. Associations between IPV and selected variables were based on Chi-square test and we used binary logistic regression to assess factors associated with women\u2019s perpetration to physical IPV and Odds Ratio (OR) as outcome measures with their 95\u00a0% confidence intervals (CI).The lifetime exposure to IPV was 65\u00a0% among ever-married or ever\u2013partnered women with 34, 18 and 21\u00a0% reporting current emotional, physical and sexual violence respectively. Seven percent of women reported having ever physically abused partners. The prevalence of women perpetration to physical IPV was above 10\u00a0% regardless to their exposure to emotional, physical or sexual IPV.IPV towards women in this study was high. Although rates are low, there is some evidence to suggest that women may also perpetrate IPV against their partners. Based on hypothesis of IPV and HIV co-existence, there should be strategies to address the problem of IPV especially among women. There is multiplicity of definitions for intimate partner violence. Nevertheless, the common understanding of IPV includes all physical, sexual, or psychological harms aggravated by a current or former partner. IPV includes also threats of acts and coercion or arbitrary deprivations of liberty that may occur in public or someone\u2019s private life perpetrated by the partner . AlthougIn Tanzania, the reported life-time prevalence of IPV ranges between 15 and 60\u00a0% . A multiFactors associated with violence, specifically against women, are diverse and always inter-woven. For that matter, an integrated ecological framework to understand violence against women has been developed . With thChanneling Men\u2019s Positive Involvement in a National HIV/AIDS Response to train men and women on reducing HIV risk, improving reproductive health outcomes and to increase gender-equitable norms and behaviors. We further selected two wards .The United Republic of Tanzania is a union between the mainland and the Archipelago of Zanzibar and Pemba. Tanzania mainland has a total population of 43.6 million of which 33.9 and 33.0\u00a0% of the rural population aged between 25 and 50\u00a0years are males and females respectively . By the Data for this report are extracted from a cross-sectional study to evaluate CHAMPION\u2019S (MAP - Men as Partners) project in which the study design was quasi experimental \u2013 two arms . This design was applied because of its simplicity to implement. Due to logistical challenges, the two groups  were not assigned randomly. However, in both groups, we conducted the pre-test to both groups before conducting the training to the experimental group only. Then, a post-test was performed to assess if there were any behavior changes between and within the study groups.We estimated a sample of 1,620 independent (not pairs) adults (aged between 25 to 50\u00a0years) women and men. Eligibility criteria included having been ever-partnered. This sample size was calculated for a quasi experimental design in order to detect at least a 10\u00a0% difference between study arms with 80\u00a0% power, a 95\u00a0% confidence interval, and accounting for a 10\u00a0% loss to follow-up. Although the main focus was men, a ratio of one woman to 2 men per site  was used in order to gather information related to women and men. Therefore, in each ward we selected streets randomly and then we systematically (based on the number of households) selected a household targeting eligible women and men in a zigzag pattern (left and right of the street) to get two men and one woman until the required sample size is attained. For the purpose of this paper, we use a sub-sample of women only.Each respondent was invited to participate after signing the consent form. We ensured safety of both study participants and of the interviewer. Also, participants were assured of a respectful and non-threatening participation and freedom to withdraw from participating in the interview participation was voluntary and a participant can withdraw at any time. No personal identifiers were collected from any study participant. Also to enhance freedom of expression, all interviews were sex-matched; a female participant was interviewed by a female interviewer. All interviews were conducted in a strict private room close to or in the house of a study participant with a calm environment to allow both freedom of expression and to enhance confidentiality.Variables that were collected included background information  of the respondent and reported incidences of intimate partner violence . The components for the assessment of IPV were threats and actual physical violence, sexual and emotional violence by a partner: currently (within past one month) and beyond one month but within past three months. The lifetime violence was measured by asking whether the woman ever experienced violence from the current or any previous partner. Furthermore, since also men are potentially victims of IPV, we asked if the woman ever physically hit or slapped or did anything that could harm her partner even when the partner was not already abusing them.The questionnaire with structured questions was used to capture information on IPV among partners. Key questions on IPV were adopted from the standard Demographic and Health Survey (DHS) tool with minor modifications to suit the setup. For example:Does or did the partner ever:Say or do something to humiliate you in front of others?Threaten to hurt or harm you or someone close to you?Insult you or make you feel bad about yourselfIf yes, how many times did it happen within the one past month? The tool was translated and back-translated to and from Kiswahili, the language of communication in Tanzania. We pre-tested the tool in a similar setting as those planned for the survey to make sure questions are understandable and carry the intended meaning.Main data analyses involved descriptive statistics to characterize IPV . Looking for the association of each of the three components of IPV with selected variables, the test involved Chi-square. We used the logistic regression model to assess independent predictors of women reporting physical violence towards men perpetrated by their partners with three women\u2019s demographic factors  as independent variables. Since IPV behaviors may not be quite independent from one household to the other , we used robust estimation of variances to account correlation between IPV rates in similar settings. The level of significance used was alpha\u2009=\u20090.05.Study participants with complete data were 471 females. The majority, 317 (67.3\u00a0%) were married or cohabiting, only 115 (24.4\u00a0%) had at least secondary education. Their mean age was 32.2 (SD\u2009=\u20097.7) years. Other background characteristics are presented in Table\u00a0Out of all women interviewed, 308 (65.4\u00a0%) , reported having experienced some form of IPV. Among those reporting to have experienced any form of IPV, 137 (46.1\u00a0%) reported recent (within one month) violence. The highest reported lifetime form of IPV was emotional violence, 238 (50.5\u00a0%) . While 212 (45. 0\u00a0%)  reported lifetime physical violence, 137 (29.1\u00a0%)  of women reported lifetime sexual violence. Similarly, the reported current prevalence of physically, sexual and emotional violence was 17.6\u00a0% , 21.1\u00a0%  and 33.8\u00a0%  respectively  were affirmative that they ever physically abused their partners. Of these, five (15.6\u00a0%) reported recent (within past six months) physical abuse.In Table\u00a0In Table\u00a0In this paper, we assessed intimate partner violence (IPV) directed to women and men as reported by women in urban areas of mainland Tanzania. The consequences of IPV are diverse; including social, physical, mental outcomes and death , 22. FurWe found a relatively high (65\u00a0% for lifetime and 45\u00a0% for current) of reported any form of IPV towards women. Almost the same proportion has been reported among women in Southwest Ethiopia in 2012 ; higher In this study, 45 and 29\u00a0% of women report exposure to intimate partner physical and sexual violence. These rates are slightly higher than those from one of the previous studies in Tanzania (DHS) that reports 36 and 21\u00a0% respectively . DiffereAlthough literature on physical violence perpetrated by women towards men is scanty , in urbaIn this study we did not find any association between the prevalence of IPV and demographic characteristics. Lack of associations suggests that IPV incidents are common in many settings and among many women and men regardless of their age, education status and their marital status. Other studies have found association between IPV and age, education and marital status. For example, several studies including Andersson et al., WHO and Iliyasu et al., found links between IPV with age, education level and marital status , 14, 34.In this study, we have a couple of potential limitations. First, we used face-to-face interviews rather than a self-administered tool. By using this technique, it is possible to introduce information bias because respondents might have been offering socially desirable answers. Second, although we tried to examine independent factors associated with IPV, the selected factors were not exhaustive and missed several social factors like alcohol consumption that has been documented elsewhere . Third, To conclude, IPV is still a public health problem especially putting more women at risk. It should be more comprehended more hurting to find perpetrators of violence being one partner. In this study a substantial proportion of women report experiencing current and lifetime forms of IPV. More resources and programs should be mobilized by policymakers, public health experts and researchers are needed to address the problem of IPV. Furthermore, more data are required in this area so as to set up evidence-based strategies required for prevention and response to IPV.Channeling Men\u2019s Positive Involvement in a National HIV/AIDS Response; CI, confidence intervals; DHS, Demographic and Health Survey; IPV, intimate partner violence; MAP, Men as Partners; OR, Odds Ratio; USAID, United States Agency for International DevelopmentCHAMPION,", "texts": ["In Tanzania like in many sub-Saharan countries the data about Intimate Partner Violence (IPV) are scarce and diverse. This study aims to determine the magnitude of IPV and associated factors among ever partnered women in urban mainland Tanzania.Data for this report were extracted from a big quasi-experimental survey that was used to evaluate MAP (MAP - Men as Partners) project. Data were collected using standard questions as those in big surveys like Demographic and Health Surveys. Data analyses involved descriptive statistics to characterize IPV. Associations between IPV and selected variables were based on Chi-square test and we used binary logistic regression to assess factors associated with women\u2019s perpetration to physical IPV and Odds Ratio (OR) as outcome measures with their 95\u00a0% confidence intervals (CI).The lifetime exposure to IPV was 65\u00a0% among ever-married or ever\u2013partnered women with 34, 18 and 21\u00a0% reporting current emotional, physical and sexual violence respectively. Seven percent of women reported having ever physically abused partners. The prevalence of women perpetration to physical IPV was above 10\u00a0% regardless to their exposure to emotional, physical or sexual IPV.IPV towards women in this study was high. Although rates are low, there is some evidence to suggest that women may also perpetrate IPV against their partners. Based on hypothesis of IPV and HIV co-existence, there should be strategies to address the problem of IPV especially among women. There is multiplicity of definitions for intimate partner violence. Nevertheless, the common understanding of IPV includes all physical, sexual, or psychological harms aggravated by a current or former partner. IPV includes also threats of acts and coercion or arbitrary deprivations of liberty that may occur in public or someone\u2019s private life perpetrated by the partner . AlthougIn Tanzania, the reported life-time prevalence of IPV ranges between 15 and 60\u00a0% . A multiFactors associated with violence, specifically against women, are diverse and always inter-woven. For that matter, an integrated ecological framework to understand violence against women has been developed . With thChanneling Men\u2019s Positive Involvement in a National HIV/AIDS Response to train men and women on reducing HIV risk, improving reproductive health outcomes and to increase gender-equitable norms and behaviors. We further selected two wards .The United Republic of Tanzania is a union between the mainland and the Archipelago of Zanzibar and Pemba. Tanzania mainland has a total population of 43.6 million of which 33.9 and 33.0\u00a0% of the rural population aged between 25 and 50\u00a0years are males and females respectively . By the Data for this report are extracted from a cross-sectional study to evaluate CHAMPION\u2019S (MAP - Men as Partners) project in which the study design was quasi experimental \u2013 two arms . This design was applied because of its simplicity to implement. Due to logistical challenges, the two groups  were not assigned randomly. However, in both groups, we conducted the pre-test to both groups before conducting the training to the experimental group only. Then, a post-test was performed to assess if there were any behavior changes between and within the study groups.We estimated a sample of 1,620 independent (not pairs) adults (aged between 25 to 50\u00a0years) women and men. Eligibility criteria included having been ever-partnered. This sample size was calculated for a quasi experimental design in order to detect at least a 10\u00a0% difference between study arms with 80\u00a0% power, a 95\u00a0% confidence interval, and accounting for a 10\u00a0% loss to follow-up. Although the main focus was men, a ratio of one woman to 2 men per site  was used in order to gather information related to women and men. Therefore, in each ward we selected streets randomly and then we systematically (based on the number of households) selected a household targeting eligible women and men in a zigzag pattern (left and right of the street) to get two men and one woman until the required sample size is attained. For the purpose of this paper, we use a sub-sample of women only.Each respondent was invited to participate after signing the consent form. We ensured safety of both study participants and of the interviewer. Also, participants were assured of a respectful and non-threatening participation and freedom to withdraw from participating in the interview participation was voluntary and a participant can withdraw at any time. No personal identifiers were collected from any study participant. Also to enhance freedom of expression, all interviews were sex-matched; a female participant was interviewed by a female interviewer. All interviews were conducted in a strict private room close to or in the house of a study participant with a calm environment to allow both freedom of expression and to enhance confidentiality.Variables that were collected included background information  of the respondent and reported incidences of intimate partner violence . The components for the assessment of IPV were threats and actual physical violence, sexual and emotional violence by a partner: currently (within past one month) and beyond one month but within past three months. The lifetime violence was measured by asking whether the woman ever experienced violence from the current or any previous partner. Furthermore, since also men are potentially victims of IPV, we asked if the woman ever physically hit or slapped or did anything that could harm her partner even when the partner was not already abusing them.The questionnaire with structured questions was used to capture information on IPV among partners. Key questions on IPV were adopted from the standard Demographic and Health Survey (DHS) tool with minor modifications to suit the setup. For example:Does or did the partner ever:Say or do something to humiliate you in front of others?Threaten to hurt or harm you or someone close to you?Insult you or make you feel bad about yourselfIf yes, how many times did it happen within the one past month? The tool was translated and back-translated to and from Kiswahili, the language of communication in Tanzania. We pre-tested the tool in a similar setting as those planned for the survey to make sure questions are understandable and carry the intended meaning.Main data analyses involved descriptive statistics to characterize IPV . Looking for the association of each of the three components of IPV with selected variables, the test involved Chi-square. We used the logistic regression model to assess independent predictors of women reporting physical violence towards men perpetrated by their partners with three women\u2019s demographic factors  as independent variables. Since IPV behaviors may not be quite independent from one household to the other , we used robust estimation of variances to account correlation between IPV rates in similar settings. The level of significance used was alpha\u2009=\u20090.05.Study participants with complete data were 471 females. The majority, 317 (67.3\u00a0%) were married or cohabiting, only 115 (24.4\u00a0%) had at least secondary education. Their mean age was 32.2 (SD\u2009=\u20097.7) years. Other background characteristics are presented in Table\u00a0Out of all women interviewed, 308 (65.4\u00a0%) , reported having experienced some form of IPV. Among those reporting to have experienced any form of IPV, 137 (46.1\u00a0%) reported recent (within one month) violence. The highest reported lifetime form of IPV was emotional violence, 238 (50.5\u00a0%) . While 212 (45. 0\u00a0%)  reported lifetime physical violence, 137 (29.1\u00a0%)  of women reported lifetime sexual violence. Similarly, the reported current prevalence of physically, sexual and emotional violence was 17.6\u00a0% , 21.1\u00a0%  and 33.8\u00a0%  respectively  were affirmative that they ever physically abused their partners. Of these, five (15.6\u00a0%) reported recent (within past six months) physical abuse.In Table\u00a0In Table\u00a0In this paper, we assessed intimate partner violence (IPV) directed to women and men as reported by women in urban areas of mainland Tanzania. The consequences of IPV are diverse; including social, physical, mental outcomes and death , 22. FurWe found a relatively high (65\u00a0% for lifetime and 45\u00a0% for current) of reported any form of IPV towards women. Almost the same proportion has been reported among women in Southwest Ethiopia in 2012 ; higher In this study, 45 and 29\u00a0% of women report exposure to intimate partner physical and sexual violence. These rates are slightly higher than those from one of the previous studies in Tanzania (DHS) that reports 36 and 21\u00a0% respectively . DiffereAlthough literature on physical violence perpetrated by women towards men is scanty , in urbaIn this study we did not find any association between the prevalence of IPV and demographic characteristics. Lack of associations suggests that IPV incidents are common in many settings and among many women and men regardless of their age, education status and their marital status. Other studies have found association between IPV and age, education and marital status. For example, several studies including Andersson et al., WHO and Iliyasu et al., found links between IPV with age, education level and marital status , 14, 34.In this study, we have a couple of potential limitations. First, we used face-to-face interviews rather than a self-administered tool. By using this technique, it is possible to introduce information bias because respondents might have been offering socially desirable answers. Second, although we tried to examine independent factors associated with IPV, the selected factors were not exhaustive and missed several social factors like alcohol consumption that has been documented elsewhere . Third, To conclude, IPV is still a public health problem especially putting more women at risk. It should be more comprehended more hurting to find perpetrators of violence being one partner. In this study a substantial proportion of women report experiencing current and lifetime forms of IPV. More resources and programs should be mobilized by policymakers, public health experts and researchers are needed to address the problem of IPV. Furthermore, more data are required in this area so as to set up evidence-based strategies required for prevention and response to IPV.Channeling Men\u2019s Positive Involvement in a National HIV/AIDS Response; CI, confidence intervals; DHS, Demographic and Health Survey; IPV, intimate partner violence; MAP, Men as Partners; OR, Odds Ratio; USAID, United States Agency for International DevelopmentCHAMPION,"]}
{"representative": "Various risk factors of intimate partner violence (IPV) have been found to vary by gender. South Korea has one of the highest prevalences of IPV in the world; however, little is known about potential risk factors of IPV and whether gender influences this relationship.Using data from the 2006 Korea Welfare Panel Study, 8,877 married participants  aged \u226530 years were included. Reported IPV was categorized as verbal or physical IPV and the association between IPV and related factors was assessed by multivariate logistic regression analysis.Women were significantly more likely than men were to report IPV victimization . Wor odds of physical perpetration than women satisfied with their family. Moreover, alcohol intake was significantly associated with IPV perpetration and victimization in both genders.Significant gender-specific differences were found among factors related to perpetrating violence and being a victim of violence among adults in heterosexual relationships in South Korea. Intimate partner violence (IPV) is a worldwide public health problem as well as a serious social problem in South Korea -3. IPV iIPV causes a wide range of negative effects on the health of women -7 and chThe prevalence of reported partner violence varies greatly 15%-71%) among various countries 5%-71% am,15. In SIPV typically results due to gender inequality and is frequently considered a form of gender-based violence . ViolencFactors associated with IPV victimization among women include pregnancy, depressive symptoms, smoking, alcohol consumption, low socioeconomic status, experiencing IPV during childhood, and witnessing IPV perpetration against their mother -28. TumwIn addition, lacking a social network, emotional support, and having low perceived life satisfaction were found to be related with IPV among men and women ,33-37. FAlthough the aforementioned studies identified some factors associated with IPV, the limited sample size, lack of gender-specific analyses, and a lack of consideration for IPV perpetration among women and IPV victimization among men warrant further study. Furthermore, previous research has not considered factors related to each type of IPV . To this end, we investigated whether gender-specific differences exist in the prevalence of IPV as well as the type of the violence that was perpetrated or experienced.Data from the nationally representative 2006 Korea Welfare Panel Study (KOWEPS) performed by the Korean Institute of Social and Health Affairs in conjunction with Social Welfare Research Institute of Seoul National University were used for this study. Details of this study have been published elsewhere ,39. BrieIn the 2006 dataset, 18,856 men and women were recruited. Of them, 16,084 (85.29%) men and women aged 19 or older participated in the survey. For our analyses, only those who were older than 30 years old and married were included leaving 9,667 men and women. The 16 participants who were younger than 30 and married were excluded from our analysis because, according to the National Statistical Office in South Korea, the average age of marriage among males and females was 32.1 was and 29.4 in 2012, respectively . By limiDuring data collection, participants were asked 13 questions pertaining to the level and type of violence experienced in their marriage over the past 12 months. Verbal IPV was assessed by asking how often in the past 12 months their spouse was (1) insulting, (2) made a malicious remark, or (3) threatened them. Physical IPV was assessed across ten violent activities. Respondents were asked how often in the past 12 months their spouse perpetrated the following physically violent activities at him/her: (1) threw something, (2) pushed, (3) slapped, (4) kicked or punched, (5) used an object to hit, (6) beat, (7) threatened using a weapon like a knife, (8) choked, (9) caused a sprain or bruise, or (10) caused him/her to be hospitalized after a violent encounter. These questions were adopted from the Conflict Tactics Scale . In addiThe statistical models used in this study were created based on variables reported in previous studies ,41. NineParticipants were divided into five age groups, 30\u201339, 40\u201349, 50\u201359, 60\u201369, and \u226570 years, for the analysis. In addition, education level was stratified into three groups based on the highest level of education achieved as elementary school, middle or high school, or university or higher. Income was calculated according to the equivalized household income equation as the sum of the total household income from all sources including earned income, income from assets, and miscellaneous income divided by the square root of the number of household members. The equivalized income was then divided into quartiles [p-value >0.05 was considered statistically significant.Descriptive statistics were used to describe participant characteristics and report the number and percentage of participants for each variable. In addition, the prevalence of IPV was calculated for all variables. Odds ratios (OR) with 95% confidence intervals (CI) were calculated to measure the strength of the association between IPV and all possible IPV-related factors in this study population. Multivariate logistic regression models, with IPV as the dependent variable, were used to calculate gender-specific ORs. Fully adjusted ORs were calculated after controlling for all potential confounders . Sampling weights were also added to aid in generalizing our findings to the entire population of South Korea. All statistical analyses were performed using SAS version 9.2 , and a Gender-specific data on the characteristics of the study population and the prevalence of IPV are shown in Tables\u00a0The majority of men reported working full time (47.6%), had at least a middle or high school education (47.2%), were non-smokers 51.7%), and moderate drinkers (30.4%). For men, the prevalence of verbal IPV was 24.4% for victimization and 25.3% for perpetration. The prevalence of physical IPV was 3.4% for victimization and 5.1% for perpetration  and had at least a middle or high school education (47.7%). In addition, most women were nonsmokers 98.2%) and nondrinkers (69.9%). For women, the prevalence of verbal IPV was 28.2% for victimization and 26.7% for perpetration. The prevalence of physical IPV was 6.9% for victimization and 3.4% for perpetration . In addition, women tended to perpetrate verbal violence against their spouse more often than men were (26.7% vs. 25.3%). However, 5.1% of men and 3.4% of women reported perpetrating physical violence against their spouse. A similar proportion of men and women reported male-to-female violence, yet more women than men reported female-to-male violence.Women were significantly more likely than men were to report being a victim of IPV  for verbal IPV victimization, 5.49 (95% CI: 2.91-10.37) for physical IPV victimization, 2.54 (95% CI: 1.74-3.71) for verbal IPV perpetration, and 4.68 (95% CI: 2.66-8.27) for physical IPV perpetration. However, the adjusted OR among men who were dissatisfied with their personal life was 1.76 (95% CI: 1.39-2.22) for verbal IPV victimization, 3.07 (95% CI: 1.79-5.26) for physical IPV victimization, 1.69 (95% CI: 1.34-2.13) for verbal IPV perpetration, and 2.51 (95% CI: 1.60-3.95) for physical IPV perpetration when compared to men who were satisfied with their personal life. Among the measured health behaviors, men reporting high alcohol intake were more likely to have experienced verbal IPV victimization, physical IPV victimization, verbal IPV perpetration, and physical IPV perpetration. Compared with non-drinkers, the adjusted OR of heavy drinkers was 2.06 (95% CI: 1.65-2.58) for verbal IPV victimization, 2.54 (95% CI: 1.49-4.31) for physical IPV victimization, 2.00 (95% CI: 1.60-2.50) for verbal IPV perpetration, and 2.81 (95% CI: 1.84-4.30) for physical IPV perpetration , 1.53 (95% CI: 1.13-2.08), and 2.15 (95% CI: 1.21-3.83), respectively. Moreover, women with a high level of family and life satisfaction were less likely to report verbal IPV victimization, physical IPV victimization, verbal IPV perpetration, and physical IPV perpetration; these findings are similar to that among men. Compared with women who were satisfied with their family relationships, the adjusted ORs among women dissatisfied with their relationships were 3.17 (95% CI: 2.23-4.52) for verbal IPV victimization, 6.68 (95% CI: 4.23-10.56) for physical IPV victimization, 2.78 (95% CI: 1.95-3.96) for verbal IPV perpetration, and 9.46 (95% CI: 5.21-17.19) for physical IPV perpetration. Moreover, the adjusted ORs among women dissatisfied with their personal life was 1.96 (95% CI: 1.55-2.49) for verbal IPV victimization, 2.52 (95% CI: 1.64-3.89) for physical IPV victimization, 2.36 (95% CI: 1.85-3.00) for verbal IPV perpetration, and 2.23 (95% CI: 1.22-4.08) for physical IPV perpetration when compared to women who reported being satisfied with their personal life . In addition, women reported a lower rate of experiencing male perpetration than that of experiencing victimization. However, the rate of female perpetration was roughly aligned with the rate of victimization that was reported by men. One interpretation for this discrepancy may be that men underreported IPV perpetration due to a social desirability bias. Similar disparities in reporting have been found in studies conducted in other countries .The majority of research surrounding IPV has addressed violence against women, examining prevalence estimates of female victimization and male perpetration. In the current study, rates of verbal IPV victimization among females (28.2%) fell within the range of previous estimates (24.6%-55.0%) ,48, althAmong men, low education level was positively associated with perpetrating verbal violence; however, among women, low education level was positively associated with both victimizing and perpetrating verbal IPV. Previous studies have reported similar associations and have strongly suggested that future violence prevention programs should aim to increase levels of education and understanding about IPV .Our results also confirm the finding of other studies that IPV victimization and perpetration are likely to occur regardless of one\u2019s drinking habits ,47. HoweOur study has important limitations. First, the prevalence of IPV was measured over the previous 12 months; therefore, these data may have underestimated the actual prevalence of IPV in this study population. Second, the KOWEPS dataset did not measure experiences with IPV during childhood such as any exposures to domestic violence or witnessing IPV perpetration among their parents. Third, the KOWEPS dataset did not ask participants who were married whether they live with their spouse. We cannot assume that all married couples live with their spouse and this factor may influence the prevalence of IPV; therefore, future studies should investigate whether this factor is associated with IPV. Fourth, IPV related to sexual abuse was not included in the KOWEPS survey. Last, the confidence intervals estimated in our analyses were wide; therefore, future prospective studies with large sample sizes are needed to better understand these relationships.In this nationally representative study, we found that the prevalence of IPV and its associated factors were gender specific. In particular, alcohol intake, family, and life satisfaction were strongly associated with both verbal and physical IPV among men and women. In addition, the prevalence of IPV victimization was significantly higher among women than among men. Moreover, older men who were dissatisfied with their family and personal life as well as heavy drinkers were more likely to be victims of physical IPV than their counterparts were. Furthermore, older women who were dissatisfied with their family and personal life as well as heavy drinkers were more likely to perpetrate physical IPV than their counterparts were. Large, prospective studies are needed to understand the etiology of these factors for the proper implementation of preventative measures to reduce IPV in South Korea.Worldwide, gender differences in IPV have been reported and, among those countries, South Korea has one of the highest prevalences of IPV. However, the factors related to IPV in Korean adults are unknown.We found significant gender-specific differences among the factors related to IPV. In addition, the prevalences for each the type of violence perpetrated and victimized varied significantly by gender.This is the first study to utilize nationally representative data to investigate the prevalence and risk factors of IPV in South Korea. This study measured IPV as a self-reported experience over the previous 12 months, yet further data such as sexual IPV and violence during childhood were not collected; therefore, further studies are needed.IPV: Intimate partner violence.The authors have no conflicts of interest to disclose.ML developed the research question and performed the analysis, ML and KMS drafted the manuscript and interpreted the data, ML and ECP participated in the design and planning of the study and ECP is guarantor. All authors have read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2458/14/415/prepub", "texts": ["Various risk factors of intimate partner violence (IPV) have been found to vary by gender. South Korea has one of the highest prevalences of IPV in the world; however, little is known about potential risk factors of IPV and whether gender influences this relationship.Using data from the 2006 Korea Welfare Panel Study, 8,877 married participants  aged \u226530 years were included. Reported IPV was categorized as verbal or physical IPV and the association between IPV and related factors was assessed by multivariate logistic regression analysis.Women were significantly more likely than men were to report IPV victimization . Wor odds of physical perpetration than women satisfied with their family. Moreover, alcohol intake was significantly associated with IPV perpetration and victimization in both genders.Significant gender-specific differences were found among factors related to perpetrating violence and being a victim of violence among adults in heterosexual relationships in South Korea. Intimate partner violence (IPV) is a worldwide public health problem as well as a serious social problem in South Korea -3. IPV iIPV causes a wide range of negative effects on the health of women -7 and chThe prevalence of reported partner violence varies greatly 15%-71%) among various countries 5%-71% am,15. In SIPV typically results due to gender inequality and is frequently considered a form of gender-based violence . ViolencFactors associated with IPV victimization among women include pregnancy, depressive symptoms, smoking, alcohol consumption, low socioeconomic status, experiencing IPV during childhood, and witnessing IPV perpetration against their mother -28. TumwIn addition, lacking a social network, emotional support, and having low perceived life satisfaction were found to be related with IPV among men and women ,33-37. FAlthough the aforementioned studies identified some factors associated with IPV, the limited sample size, lack of gender-specific analyses, and a lack of consideration for IPV perpetration among women and IPV victimization among men warrant further study. Furthermore, previous research has not considered factors related to each type of IPV . To this end, we investigated whether gender-specific differences exist in the prevalence of IPV as well as the type of the violence that was perpetrated or experienced.Data from the nationally representative 2006 Korea Welfare Panel Study (KOWEPS) performed by the Korean Institute of Social and Health Affairs in conjunction with Social Welfare Research Institute of Seoul National University were used for this study. Details of this study have been published elsewhere ,39. BrieIn the 2006 dataset, 18,856 men and women were recruited. Of them, 16,084 (85.29%) men and women aged 19 or older participated in the survey. For our analyses, only those who were older than 30 years old and married were included leaving 9,667 men and women. The 16 participants who were younger than 30 and married were excluded from our analysis because, according to the National Statistical Office in South Korea, the average age of marriage among males and females was 32.1 was and 29.4 in 2012, respectively . By limiDuring data collection, participants were asked 13 questions pertaining to the level and type of violence experienced in their marriage over the past 12 months. Verbal IPV was assessed by asking how often in the past 12 months their spouse was (1) insulting, (2) made a malicious remark, or (3) threatened them. Physical IPV was assessed across ten violent activities. Respondents were asked how often in the past 12 months their spouse perpetrated the following physically violent activities at him/her: (1) threw something, (2) pushed, (3) slapped, (4) kicked or punched, (5) used an object to hit, (6) beat, (7) threatened using a weapon like a knife, (8) choked, (9) caused a sprain or bruise, or (10) caused him/her to be hospitalized after a violent encounter. These questions were adopted from the Conflict Tactics Scale . In addiThe statistical models used in this study were created based on variables reported in previous studies ,41. NineParticipants were divided into five age groups, 30\u201339, 40\u201349, 50\u201359, 60\u201369, and \u226570 years, for the analysis. In addition, education level was stratified into three groups based on the highest level of education achieved as elementary school, middle or high school, or university or higher. Income was calculated according to the equivalized household income equation as the sum of the total household income from all sources including earned income, income from assets, and miscellaneous income divided by the square root of the number of household members. The equivalized income was then divided into quartiles [p-value >0.05 was considered statistically significant.Descriptive statistics were used to describe participant characteristics and report the number and percentage of participants for each variable. In addition, the prevalence of IPV was calculated for all variables. Odds ratios (OR) with 95% confidence intervals (CI) were calculated to measure the strength of the association between IPV and all possible IPV-related factors in this study population. Multivariate logistic regression models, with IPV as the dependent variable, were used to calculate gender-specific ORs. Fully adjusted ORs were calculated after controlling for all potential confounders . Sampling weights were also added to aid in generalizing our findings to the entire population of South Korea. All statistical analyses were performed using SAS version 9.2 , and a Gender-specific data on the characteristics of the study population and the prevalence of IPV are shown in Tables\u00a0The majority of men reported working full time (47.6%), had at least a middle or high school education (47.2%), were non-smokers 51.7%), and moderate drinkers (30.4%). For men, the prevalence of verbal IPV was 24.4% for victimization and 25.3% for perpetration. The prevalence of physical IPV was 3.4% for victimization and 5.1% for perpetration  and had at least a middle or high school education (47.7%). In addition, most women were nonsmokers 98.2%) and nondrinkers (69.9%). For women, the prevalence of verbal IPV was 28.2% for victimization and 26.7% for perpetration. The prevalence of physical IPV was 6.9% for victimization and 3.4% for perpetration . In addition, women tended to perpetrate verbal violence against their spouse more often than men were (26.7% vs. 25.3%). However, 5.1% of men and 3.4% of women reported perpetrating physical violence against their spouse. A similar proportion of men and women reported male-to-female violence, yet more women than men reported female-to-male violence.Women were significantly more likely than men were to report being a victim of IPV  for verbal IPV victimization, 5.49 (95% CI: 2.91-10.37) for physical IPV victimization, 2.54 (95% CI: 1.74-3.71) for verbal IPV perpetration, and 4.68 (95% CI: 2.66-8.27) for physical IPV perpetration. However, the adjusted OR among men who were dissatisfied with their personal life was 1.76 (95% CI: 1.39-2.22) for verbal IPV victimization, 3.07 (95% CI: 1.79-5.26) for physical IPV victimization, 1.69 (95% CI: 1.34-2.13) for verbal IPV perpetration, and 2.51 (95% CI: 1.60-3.95) for physical IPV perpetration when compared to men who were satisfied with their personal life. Among the measured health behaviors, men reporting high alcohol intake were more likely to have experienced verbal IPV victimization, physical IPV victimization, verbal IPV perpetration, and physical IPV perpetration. Compared with non-drinkers, the adjusted OR of heavy drinkers was 2.06 (95% CI: 1.65-2.58) for verbal IPV victimization, 2.54 (95% CI: 1.49-4.31) for physical IPV victimization, 2.00 (95% CI: 1.60-2.50) for verbal IPV perpetration, and 2.81 (95% CI: 1.84-4.30) for physical IPV perpetration , 1.53 (95% CI: 1.13-2.08), and 2.15 (95% CI: 1.21-3.83), respectively. Moreover, women with a high level of family and life satisfaction were less likely to report verbal IPV victimization, physical IPV victimization, verbal IPV perpetration, and physical IPV perpetration; these findings are similar to that among men. Compared with women who were satisfied with their family relationships, the adjusted ORs among women dissatisfied with their relationships were 3.17 (95% CI: 2.23-4.52) for verbal IPV victimization, 6.68 (95% CI: 4.23-10.56) for physical IPV victimization, 2.78 (95% CI: 1.95-3.96) for verbal IPV perpetration, and 9.46 (95% CI: 5.21-17.19) for physical IPV perpetration. Moreover, the adjusted ORs among women dissatisfied with their personal life was 1.96 (95% CI: 1.55-2.49) for verbal IPV victimization, 2.52 (95% CI: 1.64-3.89) for physical IPV victimization, 2.36 (95% CI: 1.85-3.00) for verbal IPV perpetration, and 2.23 (95% CI: 1.22-4.08) for physical IPV perpetration when compared to women who reported being satisfied with their personal life . In addition, women reported a lower rate of experiencing male perpetration than that of experiencing victimization. However, the rate of female perpetration was roughly aligned with the rate of victimization that was reported by men. One interpretation for this discrepancy may be that men underreported IPV perpetration due to a social desirability bias. Similar disparities in reporting have been found in studies conducted in other countries .The majority of research surrounding IPV has addressed violence against women, examining prevalence estimates of female victimization and male perpetration. In the current study, rates of verbal IPV victimization among females (28.2%) fell within the range of previous estimates (24.6%-55.0%) ,48, althAmong men, low education level was positively associated with perpetrating verbal violence; however, among women, low education level was positively associated with both victimizing and perpetrating verbal IPV. Previous studies have reported similar associations and have strongly suggested that future violence prevention programs should aim to increase levels of education and understanding about IPV .Our results also confirm the finding of other studies that IPV victimization and perpetration are likely to occur regardless of one\u2019s drinking habits ,47. HoweOur study has important limitations. First, the prevalence of IPV was measured over the previous 12 months; therefore, these data may have underestimated the actual prevalence of IPV in this study population. Second, the KOWEPS dataset did not measure experiences with IPV during childhood such as any exposures to domestic violence or witnessing IPV perpetration among their parents. Third, the KOWEPS dataset did not ask participants who were married whether they live with their spouse. We cannot assume that all married couples live with their spouse and this factor may influence the prevalence of IPV; therefore, future studies should investigate whether this factor is associated with IPV. Fourth, IPV related to sexual abuse was not included in the KOWEPS survey. Last, the confidence intervals estimated in our analyses were wide; therefore, future prospective studies with large sample sizes are needed to better understand these relationships.In this nationally representative study, we found that the prevalence of IPV and its associated factors were gender specific. In particular, alcohol intake, family, and life satisfaction were strongly associated with both verbal and physical IPV among men and women. In addition, the prevalence of IPV victimization was significantly higher among women than among men. Moreover, older men who were dissatisfied with their family and personal life as well as heavy drinkers were more likely to be victims of physical IPV than their counterparts were. Furthermore, older women who were dissatisfied with their family and personal life as well as heavy drinkers were more likely to perpetrate physical IPV than their counterparts were. Large, prospective studies are needed to understand the etiology of these factors for the proper implementation of preventative measures to reduce IPV in South Korea.Worldwide, gender differences in IPV have been reported and, among those countries, South Korea has one of the highest prevalences of IPV. However, the factors related to IPV in Korean adults are unknown.We found significant gender-specific differences among the factors related to IPV. In addition, the prevalences for each the type of violence perpetrated and victimized varied significantly by gender.This is the first study to utilize nationally representative data to investigate the prevalence and risk factors of IPV in South Korea. This study measured IPV as a self-reported experience over the previous 12 months, yet further data such as sexual IPV and violence during childhood were not collected; therefore, further studies are needed.IPV: Intimate partner violence.The authors have no conflicts of interest to disclose.ML developed the research question and performed the analysis, ML and KMS drafted the manuscript and interpreted the data, ML and ECP participated in the design and planning of the study and ECP is guarantor. All authors have read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2458/14/415/prepub"]}
{"representative": "In Rwanda, women who self-reported in household surveys ever experiencing intimate partner violence (IPV) increased from 34\u00a0% in 2005 to 56\u00a0% in 2010. This coincided with a new constitution and majority-female elected parliament in 2003, and 2008 legislation protecting against gender-based violence. The increase in self-reported IPV may reflect improved social power for women, and/or disruptions to traditional gender roles that increased actual IPV.This is a cross-sectional study of IPV in 4338 couples interviewed in the 2005 and 2010 Rwanda Demographic and Health Surveys (RDHSs). Factors associated with physical or sexual IPV in the last 12\u00a0months were modeled using manual backward stepwise logistic regression. Analyses were conducted in Stata v13 adjusting for complex survey design.p\u2009<\u20090.05) were: experiencing emotional IPV (OR\u2009=\u200918.1), beating husband/partner unprovoked (OR\u2009=\u200912.3), witnessing IPV against mother (OR\u2009=\u20091.82), husband/partner consumes alcohol often (OR\u2009=\u20093.13), and polygynous marriage (OR\u2009=\u20091.51), whereas having a husband/partner with secondary education (OR\u2009=\u20090.43) was protective. Factors associated with increased IPV in 2010 (p\u2009<\u20090.05) were husband/partner (OR\u2009=\u20091.30) or woman (OR\u2009=\u20091.36) believes IPV is justified, husband/partner has sex with non-marital partners (OR\u2009=\u20092.52), bottom wealth quintile (OR\u2009=\u20091.25), polygynous marriage (OR\u2009=\u20092.29), having a son (OR\u2009=\u20092.05) or only daughters (OR\u2009=\u20092.58) versus no children, and having a husband/partner employed with in-kind versus cash compensation (OR\u2009=\u20091.58). In 2010, woman being involved with her own health (OR\u2009=\u20090.79) or earnings (OR\u2009=\u20090.57) decision-making was protective against IPV. Several variables were not available in the 2010 RDHS.Risk factors for IPV in 2005 (Abunzi mediators to hear IPV cases in communities, and involvement of men in grassroots efforts to redefine masculinity in Rwanda are suggested. Additional research is needed to understand why self-reported IPV has increased in Rwanda, and to evaluate effectiveness of IPV interventions.Our results may provide evidence of both increased self-reporting of IPV and social power disruption. Rwanda\u2019s Isange One Stop Center project, with medical, legal, and psychosocial services for domestic violence victims, is currently scaling to all 44 district hospitals, and police station gender desks reduce barriers to legal reporting of IPV. Additional support to  Intimate partner violence (IPV) describes physical, sexual, or psychological harm by a current or past partner. Not only does IPV compromise survivors\u2019 basic human rights, physical and sexual assault can result in direct physical harm, sexually transmitted infections, or pregnancy, and all IPV can result in long-term mental and physical health problems , 2. WhilWithin region and country, however, experiences of IPV vary widely, underscoring differences in national histories, institutional policies, cultural identities, resources, and other factors. When comparable measures and methods are used to measure lifetime prevalence of physical and sexual violence across national surveys \u20137, they Rwanda is a small, densely populated country that has undergone rapid demographic, social, and economic transition in the last 20\u00a0years since the Tutsi Genocide that killed around 1 million people. In the period between 2005 and 2010, fertility rates fell from 6.1 to 4.6 children per woman, child mortality was halved from 152 to 76 deaths per 1000 live births, and the percent of women completing secondary school increased from 1.6 to 4.3\u00a0% , 9. MeanWomen\u2019s political representation and legal protection is an important step toward gender equity. Several factors may contribute to women\u2019s political representation in Rwanda; foremost, Rwanda\u2019s government has prioritized women\u2019s political inclusion. In 2003, new legislation reserved 24 of 80 parliamentary seats for women-only parliamentarians to be filled by women-only voters . While tViolence in intimate partnerships is a common phenomenon worldwide, and is partially attributed to couples spending lots of time with each other . Time exIn Africa, systematic gender inequality is often reinforced by cultural traditions of men in roles of head of household in charge of family finances and decisions , as wellGender roles in Rwanda are in the midst of rapid transition, and the implications for IPV are not well understood. In a qualitative study in Rwanda after 2003, women described experiencing greater respect by family and community members, new confidence to speak in public forums, more autonomy and opportunities, as well as increased friction with their brothers and husbands, perceptions that men were withdrawing from politics, and feelings that the institution of marriage had been disrupted due to rapid changes in conventional gender roles . A 2010 This analysis is based to the 2005 and 2010 Rwanda Demographic and Health Surveys (DHSs), which are nationally and sub-nationally representative two-stage cluster samples, conducted every 5\u00a0years to monitor demographic, socioeconomic, and health indicators . In bothOf the 11,321 and 13,671 women interviewed in 2005 and 2010, respectively, 4066 and 5008 were randomly selected and agreed to complete a special module about domestic violence. Only one woman per household was selected for the domestic violence module to ensure that no one else in the household knew about sensitive questions that could compromise her safety, and to minimize the total number of women asked to describe traumatic events. Female interviewers received special training to conduct secure, confidential interviews in respondents\u2019 homes and administered the domestic violence module in face-to-face interviews; they were supposed to skip the module if a confidential interviewing environment was not possible. According to the DHS datasets, 100\u00a0% of women in 2005 and more than 99\u00a0% of women in 2010 who were selected for the domestic violence module completed it. Of the 9074 women interviewed across the two surveys, 4338 had husbands/partners who were interviewed in the men\u2019s survey. In this analysis of 4338 couples , we link women\u2019s self-reports of intimate partner violence in the last 12\u00a0months with husband/partner\u2019s survey responses based on wife-ID in the men\u2019s questionnaire.In the domestic violence module, women were asked directly about their experiences of physical and sexual violence in the last 12\u00a0months and this outcome was modeled as a binary variable. In the 2005 survey only, women reported emotional IPV, physical violence perpetrated against her husband/partner when he was not already physically hurting her, history of her father beating her mother, and frequency of husband/partner\u2019s alcohol usage, all of which are key risk factors for IPV against women , 21\u201325. Both the 2005 and 2010 DHSs were reviewed and approved by the Macro International Internal Review Board, Rwanda\u2019s National Institute of Statistics, and the National Ethics Committee of Rwanda. We were granted permission by Macro International, Inc. to use these de-identified data for this analysis.p\u2009<\u20090.05) socio-demographic characteristics of women in this study with married/partnered women not in the study (because their partner was not interviewed) and divorced or separated women. Then we defined 25 potential covariates and tested bivariate Chi-square distributions among women who had, and had not, experienced physical or sexual IPV in the last 12\u00a0months. Non-collinear (Pearson correlation r\u2009<\u20090.5) variables associated with IPV (at p\u2009<\u20090.1) were retained for multivariable model building. Finally, we used manual backward stepwise logistic regression, first removing variables that were least associated with IPV and retaining those variables that were associated with IPV (p\u2009<\u20090.05). Separate models were fit for 2005, for 2005 using the reduced set of variables available in 2010, and for 2010. The analysis was carried out in Stata version 13 using survey commands to apply sampling probability weights, account for clustering and stratification in the sample design, and perform subpopulation analysis in couples only. We presented final models as odds ratios (ORs) with 95\u00a0% confidence intervals.We used multivariable regression to identify belief or behavioral and socio-demographic factors associated with sexual or physical IPV against women in Rwanda in 2005 and 2010. We used percentages and Chi-square tests to compare   (Table\u00a0p\u2009<\u20090.001), though only nine women (<1\u00a0%) reported this behavior. No other beliefs or behaviors were associated with IPV in 2005. A number of socio-demographic factors were associated with IPV in 2005 (p\u2009<\u20090.1) including rural residence, polygynous marriage, having any children, there being no adults other than the couple in the household, having a husband/partner with less than secondary education, and the woman having less than secondary education.In bivariate analysis in 2005, sexual or physical IPV was associated with emotional IPV (84.7\u00a0%), witnessing physical violence by father against mother as a child (31.5\u00a0%), and having a partner who consumes alcohol often (54.3\u00a0%) (p\u2009<\u20090.1) including partner believes a man can beat his wife, woman believes a man can beat his wife, woman is not involved with her own health decision-making, woman is not involved with decision-making about her earnings, husband/partner has sex with non-wife\u00a0partner(s), and the woman says she cannot refuse sex with her partner or request use of a condom.In 2010, many of the same socio-demographic factors were associated with IPV, however, a number of beliefs and behaviors were newly associated with IPV (p\u2009<\u20090.001) of sexual or physical IPV, and women who reported beating their husband/partner unprovoked had 12 times the odds (p\u2009<\u20090.01) of sexual or physical IPV. Having a partner that consumes alcohol very often , witnessing physical IPV against her mother in childhood , and being in a polygynous marriage  were also associated with increased odds of sexual or physical IPV. Women who had a partner with secondary or higher education had lower odds of IPV . When emotional violence, woman beats husband/partner unprovoked, woman witnessed IPV against mother in childhood, and husband/partner consumes alcohol often were removed from the model to make it comparable to the 2010 analysis, two additional demographic characteristics were associated with IPV: women\u2019s primary education versus no education , and woman has at least one son  or daughters only  versus no children.In the 2005 multivariable analysis, two factors stand out as being strongly associated with IPV Table\u00a0. Women wp\u2009<\u20090.05), woman believes a man is justified to beat his wife , and partner has sex with non-wife partner(s)  were all associated with greater odds of IPV. Furthermore, woman being involved with decisions about her own health  or about her own earnings  versus her partner alone were protective against IPV. Being a household in the bottom wealth quintile , being in a polygynous marriage , having a son  or only daughters  versus no children, and having a partner employed with in-kind versus cash earnings  were associated with greater odds of IPV.Several beliefs and behaviors that were not associated with IPV in 2005 were significant in the 2010 multivariate analysis. Partner believes a man is justified to beat his wife  self-reported in household surveys doubled between 2005 and 2010 which coincided with a rise in the percent of women who say that IPV is justified from 46.7\u00a0% to 57.0\u00a0%. In 2010, nearly half of all partnered women experienced physical or sexual IPV in the previous 12\u00a0months, and IPV tended to occur in tandem with multiple other forms of violence. Our 2005 finding that women who experienced emotional violence , who witIn our study, IPV was associated with high alcohol usage by husbands/partners, which is consistent with findings from diverse settings including Brazil, Kenya, and India , 27\u201329. Our 2010 finding that IPV was associated with husbands/partners who earned in-kind rather than cash compensation may provide evidence of social power disruptions within relationships as a source of increased incidence of IPV in Rwanda. In-kind rather than cash compensation may be related to the husband/partner having low education , 22, 33 Certain family dynamics such as polygynous marriage and having children are slow to change in response to women\u2019s changing roles in society, and it is therefore not surprising that these two factors remained significantly associated with IPV across years in our study. The practice of polygyny in Rwanda is illegal, uncommon, and may be falling . In 2005While there is great variability in risk factors for IPV across countries, IPV beliefs and behaviors are commonly associated with IPV incidence , 42. TheGiven the complexity of IPV and the mixed evidence in this analysis, the higher incidence of IPV in 2010 may have resulted from both improved self-reporting and increased incidence of IPV due to social disruption. As such, we recommend multiple avenues to address IPV in Rwanda at a social-level. To the extent that prevalent violence against women already existed due to entrenched social, cultural, or historical norms, or has been inflamed by disrupting those norms, we recommend improved legal systems to protect women against violence, and campaigns to reduce acceptance of IPV and to redefine gender roles.Abunzi community mediation system [Abunzi Secretariat which oversees mediator training and coordination with the Ministry of Justice. Like the gacaca courts, which heard genocide cases, the Abunzi system is a hybrid of traditional and modern methods of conflict resolution, and is perceived by many as more accessible and responsive than legal courts. Each Abunzi committee is comprised of at least 12 members, 30\u00a0% of whom are supposed to be women, and serve a local group of villages. While the Abunzi system may present fewer social barriers to victims of IPV than the justice system, many Abunzi committees do not maintain 30\u00a0%\u2009+\u2009women representation, mediations are public, and mediators are often unfamiliar with existing laws and turn to customary laws that may be prejudiced against women [Abunzi system may be a positive forum for certain IPV cases, especially if the victim is comfortable with the process, and the system is able to support couples to effectively communicate through differences that prevent future violence. However, better support and training of Abunzi mediators is needed to appropriately protect victims of domestic violence according to national law.An alternative to the One Stop Center program is the n system  which wast women . The AbuPressure on men to change their behaviors and perception of themselves as men without well-formed alternative models of masculinity will not lead to sustained reductions in violence , 42. Thiumaganda, the monthly national day of service, and facilitates dialogues about IPV in umugoroba w\u2019abashakanye evening meetings of five to ten couples [Perhaps as a result of atypically top-down approaches, Rwandans overall hold highly inequitable attitudes about gender roles; for example, 61\u00a0% of Rwandan men agree with the statement \u201cchanging diapers, giving kids a bath and feeding kids are the mother\u2019s responsibility\u201d , and DHS couples , furtherThe doubling in self-reported IPV in Rwanda between 2005 and 2010 is deeply concerning, and further investigations of reasons for this increase are urgently needed. This study summarizes trends, correlates, and broad hypotheses for IPV, however, the cross-sectional nature of the DHS does not allow us to draw causal conclusions about predictors or consequences of IPV. Furthermore, measurement of physical and sexual IPV in household surveys is subject to under-reporting due to interviewer traits and difficulty securing privacy in smaller, densely populated homes . We findAbunzi mediators are able to address IPV should be investigated. Campaigns that involve men and women in redefining gender roles could be an important contribution to the gender equality agenda moving forward in Rwanda, and the effects of these campaigns on IPV and IPV perceptions should be systematically evaluated.The 2015 DHS was recently completed but not released at the time of this writing, and results from that survey might provide important insight about trends in IPV. Preliminary results of the 2015 DHS indicate continued rapid economic development in Rwanda, which is expected to correlate with a drop in IPV , 17. We Rwanda has one of the highest self-reported rates of intimate partner violence against women worldwide, and multiple forms of current or past violence are reported by the same women. Doubling in self-reported violence between 2005 and 2010 coincided with major political and social gains. While the Rwandan health and legal sectors have multiple initiatives to support victims, additional campaigns may be needed to shift public perception and perpetration of intimate partner violence. The impact of these programs, and changes in reported violence, need further investigation.", "texts": ["In Rwanda, women who self-reported in household surveys ever experiencing intimate partner violence (IPV) increased from 34\u00a0% in 2005 to 56\u00a0% in 2010. This coincided with a new constitution and majority-female elected parliament in 2003, and 2008 legislation protecting against gender-based violence. The increase in self-reported IPV may reflect improved social power for women, and/or disruptions to traditional gender roles that increased actual IPV.This is a cross-sectional study of IPV in 4338 couples interviewed in the 2005 and 2010 Rwanda Demographic and Health Surveys (RDHSs). Factors associated with physical or sexual IPV in the last 12\u00a0months were modeled using manual backward stepwise logistic regression. Analyses were conducted in Stata v13 adjusting for complex survey design.p\u2009<\u20090.05) were: experiencing emotional IPV (OR\u2009=\u200918.1), beating husband/partner unprovoked (OR\u2009=\u200912.3), witnessing IPV against mother (OR\u2009=\u20091.82), husband/partner consumes alcohol often (OR\u2009=\u20093.13), and polygynous marriage (OR\u2009=\u20091.51), whereas having a husband/partner with secondary education (OR\u2009=\u20090.43) was protective. Factors associated with increased IPV in 2010 (p\u2009<\u20090.05) were husband/partner (OR\u2009=\u20091.30) or woman (OR\u2009=\u20091.36) believes IPV is justified, husband/partner has sex with non-marital partners (OR\u2009=\u20092.52), bottom wealth quintile (OR\u2009=\u20091.25), polygynous marriage (OR\u2009=\u20092.29), having a son (OR\u2009=\u20092.05) or only daughters (OR\u2009=\u20092.58) versus no children, and having a husband/partner employed with in-kind versus cash compensation (OR\u2009=\u20091.58). In 2010, woman being involved with her own health (OR\u2009=\u20090.79) or earnings (OR\u2009=\u20090.57) decision-making was protective against IPV. Several variables were not available in the 2010 RDHS.Risk factors for IPV in 2005 (Abunzi mediators to hear IPV cases in communities, and involvement of men in grassroots efforts to redefine masculinity in Rwanda are suggested. Additional research is needed to understand why self-reported IPV has increased in Rwanda, and to evaluate effectiveness of IPV interventions.Our results may provide evidence of both increased self-reporting of IPV and social power disruption. Rwanda\u2019s Isange One Stop Center project, with medical, legal, and psychosocial services for domestic violence victims, is currently scaling to all 44 district hospitals, and police station gender desks reduce barriers to legal reporting of IPV. Additional support to  Intimate partner violence (IPV) describes physical, sexual, or psychological harm by a current or past partner. Not only does IPV compromise survivors\u2019 basic human rights, physical and sexual assault can result in direct physical harm, sexually transmitted infections, or pregnancy, and all IPV can result in long-term mental and physical health problems , 2. WhilWithin region and country, however, experiences of IPV vary widely, underscoring differences in national histories, institutional policies, cultural identities, resources, and other factors. When comparable measures and methods are used to measure lifetime prevalence of physical and sexual violence across national surveys \u20137, they Rwanda is a small, densely populated country that has undergone rapid demographic, social, and economic transition in the last 20\u00a0years since the Tutsi Genocide that killed around 1 million people. In the period between 2005 and 2010, fertility rates fell from 6.1 to 4.6 children per woman, child mortality was halved from 152 to 76 deaths per 1000 live births, and the percent of women completing secondary school increased from 1.6 to 4.3\u00a0% , 9. MeanWomen\u2019s political representation and legal protection is an important step toward gender equity. Several factors may contribute to women\u2019s political representation in Rwanda; foremost, Rwanda\u2019s government has prioritized women\u2019s political inclusion. In 2003, new legislation reserved 24 of 80 parliamentary seats for women-only parliamentarians to be filled by women-only voters . While tViolence in intimate partnerships is a common phenomenon worldwide, and is partially attributed to couples spending lots of time with each other . Time exIn Africa, systematic gender inequality is often reinforced by cultural traditions of men in roles of head of household in charge of family finances and decisions , as wellGender roles in Rwanda are in the midst of rapid transition, and the implications for IPV are not well understood. In a qualitative study in Rwanda after 2003, women described experiencing greater respect by family and community members, new confidence to speak in public forums, more autonomy and opportunities, as well as increased friction with their brothers and husbands, perceptions that men were withdrawing from politics, and feelings that the institution of marriage had been disrupted due to rapid changes in conventional gender roles . A 2010 This analysis is based to the 2005 and 2010 Rwanda Demographic and Health Surveys (DHSs), which are nationally and sub-nationally representative two-stage cluster samples, conducted every 5\u00a0years to monitor demographic, socioeconomic, and health indicators . In bothOf the 11,321 and 13,671 women interviewed in 2005 and 2010, respectively, 4066 and 5008 were randomly selected and agreed to complete a special module about domestic violence. Only one woman per household was selected for the domestic violence module to ensure that no one else in the household knew about sensitive questions that could compromise her safety, and to minimize the total number of women asked to describe traumatic events. Female interviewers received special training to conduct secure, confidential interviews in respondents\u2019 homes and administered the domestic violence module in face-to-face interviews; they were supposed to skip the module if a confidential interviewing environment was not possible. According to the DHS datasets, 100\u00a0% of women in 2005 and more than 99\u00a0% of women in 2010 who were selected for the domestic violence module completed it. Of the 9074 women interviewed across the two surveys, 4338 had husbands/partners who were interviewed in the men\u2019s survey. In this analysis of 4338 couples , we link women\u2019s self-reports of intimate partner violence in the last 12\u00a0months with husband/partner\u2019s survey responses based on wife-ID in the men\u2019s questionnaire.In the domestic violence module, women were asked directly about their experiences of physical and sexual violence in the last 12\u00a0months and this outcome was modeled as a binary variable. In the 2005 survey only, women reported emotional IPV, physical violence perpetrated against her husband/partner when he was not already physically hurting her, history of her father beating her mother, and frequency of husband/partner\u2019s alcohol usage, all of which are key risk factors for IPV against women , 21\u201325. Both the 2005 and 2010 DHSs were reviewed and approved by the Macro International Internal Review Board, Rwanda\u2019s National Institute of Statistics, and the National Ethics Committee of Rwanda. We were granted permission by Macro International, Inc. to use these de-identified data for this analysis.p\u2009<\u20090.05) socio-demographic characteristics of women in this study with married/partnered women not in the study (because their partner was not interviewed) and divorced or separated women. Then we defined 25 potential covariates and tested bivariate Chi-square distributions among women who had, and had not, experienced physical or sexual IPV in the last 12\u00a0months. Non-collinear (Pearson correlation r\u2009<\u20090.5) variables associated with IPV (at p\u2009<\u20090.1) were retained for multivariable model building. Finally, we used manual backward stepwise logistic regression, first removing variables that were least associated with IPV and retaining those variables that were associated with IPV (p\u2009<\u20090.05). Separate models were fit for 2005, for 2005 using the reduced set of variables available in 2010, and for 2010. The analysis was carried out in Stata version 13 using survey commands to apply sampling probability weights, account for clustering and stratification in the sample design, and perform subpopulation analysis in couples only. We presented final models as odds ratios (ORs) with 95\u00a0% confidence intervals.We used multivariable regression to identify belief or behavioral and socio-demographic factors associated with sexual or physical IPV against women in Rwanda in 2005 and 2010. We used percentages and Chi-square tests to compare   (Table\u00a0p\u2009<\u20090.001), though only nine women (<1\u00a0%) reported this behavior. No other beliefs or behaviors were associated with IPV in 2005. A number of socio-demographic factors were associated with IPV in 2005 (p\u2009<\u20090.1) including rural residence, polygynous marriage, having any children, there being no adults other than the couple in the household, having a husband/partner with less than secondary education, and the woman having less than secondary education.In bivariate analysis in 2005, sexual or physical IPV was associated with emotional IPV (84.7\u00a0%), witnessing physical violence by father against mother as a child (31.5\u00a0%), and having a partner who consumes alcohol often (54.3\u00a0%) (p\u2009<\u20090.1) including partner believes a man can beat his wife, woman believes a man can beat his wife, woman is not involved with her own health decision-making, woman is not involved with decision-making about her earnings, husband/partner has sex with non-wife\u00a0partner(s), and the woman says she cannot refuse sex with her partner or request use of a condom.In 2010, many of the same socio-demographic factors were associated with IPV, however, a number of beliefs and behaviors were newly associated with IPV (p\u2009<\u20090.001) of sexual or physical IPV, and women who reported beating their husband/partner unprovoked had 12 times the odds (p\u2009<\u20090.01) of sexual or physical IPV. Having a partner that consumes alcohol very often , witnessing physical IPV against her mother in childhood , and being in a polygynous marriage  were also associated with increased odds of sexual or physical IPV. Women who had a partner with secondary or higher education had lower odds of IPV . When emotional violence, woman beats husband/partner unprovoked, woman witnessed IPV against mother in childhood, and husband/partner consumes alcohol often were removed from the model to make it comparable to the 2010 analysis, two additional demographic characteristics were associated with IPV: women\u2019s primary education versus no education , and woman has at least one son  or daughters only  versus no children.In the 2005 multivariable analysis, two factors stand out as being strongly associated with IPV Table\u00a0. Women wp\u2009<\u20090.05), woman believes a man is justified to beat his wife , and partner has sex with non-wife partner(s)  were all associated with greater odds of IPV. Furthermore, woman being involved with decisions about her own health  or about her own earnings  versus her partner alone were protective against IPV. Being a household in the bottom wealth quintile , being in a polygynous marriage , having a son  or only daughters  versus no children, and having a partner employed with in-kind versus cash earnings  were associated with greater odds of IPV.Several beliefs and behaviors that were not associated with IPV in 2005 were significant in the 2010 multivariate analysis. Partner believes a man is justified to beat his wife  self-reported in household surveys doubled between 2005 and 2010 which coincided with a rise in the percent of women who say that IPV is justified from 46.7\u00a0% to 57.0\u00a0%. In 2010, nearly half of all partnered women experienced physical or sexual IPV in the previous 12\u00a0months, and IPV tended to occur in tandem with multiple other forms of violence. Our 2005 finding that women who experienced emotional violence , who witIn our study, IPV was associated with high alcohol usage by husbands/partners, which is consistent with findings from diverse settings including Brazil, Kenya, and India , 27\u201329. Our 2010 finding that IPV was associated with husbands/partners who earned in-kind rather than cash compensation may provide evidence of social power disruptions within relationships as a source of increased incidence of IPV in Rwanda. In-kind rather than cash compensation may be related to the husband/partner having low education , 22, 33 Certain family dynamics such as polygynous marriage and having children are slow to change in response to women\u2019s changing roles in society, and it is therefore not surprising that these two factors remained significantly associated with IPV across years in our study. The practice of polygyny in Rwanda is illegal, uncommon, and may be falling . In 2005While there is great variability in risk factors for IPV across countries, IPV beliefs and behaviors are commonly associated with IPV incidence , 42. TheGiven the complexity of IPV and the mixed evidence in this analysis, the higher incidence of IPV in 2010 may have resulted from both improved self-reporting and increased incidence of IPV due to social disruption. As such, we recommend multiple avenues to address IPV in Rwanda at a social-level. To the extent that prevalent violence against women already existed due to entrenched social, cultural, or historical norms, or has been inflamed by disrupting those norms, we recommend improved legal systems to protect women against violence, and campaigns to reduce acceptance of IPV and to redefine gender roles.Abunzi community mediation system [Abunzi Secretariat which oversees mediator training and coordination with the Ministry of Justice. Like the gacaca courts, which heard genocide cases, the Abunzi system is a hybrid of traditional and modern methods of conflict resolution, and is perceived by many as more accessible and responsive than legal courts. Each Abunzi committee is comprised of at least 12 members, 30\u00a0% of whom are supposed to be women, and serve a local group of villages. While the Abunzi system may present fewer social barriers to victims of IPV than the justice system, many Abunzi committees do not maintain 30\u00a0%\u2009+\u2009women representation, mediations are public, and mediators are often unfamiliar with existing laws and turn to customary laws that may be prejudiced against women [Abunzi system may be a positive forum for certain IPV cases, especially if the victim is comfortable with the process, and the system is able to support couples to effectively communicate through differences that prevent future violence. However, better support and training of Abunzi mediators is needed to appropriately protect victims of domestic violence according to national law.An alternative to the One Stop Center program is the n system  which wast women . The AbuPressure on men to change their behaviors and perception of themselves as men without well-formed alternative models of masculinity will not lead to sustained reductions in violence , 42. Thiumaganda, the monthly national day of service, and facilitates dialogues about IPV in umugoroba w\u2019abashakanye evening meetings of five to ten couples [Perhaps as a result of atypically top-down approaches, Rwandans overall hold highly inequitable attitudes about gender roles; for example, 61\u00a0% of Rwandan men agree with the statement \u201cchanging diapers, giving kids a bath and feeding kids are the mother\u2019s responsibility\u201d , and DHS couples , furtherThe doubling in self-reported IPV in Rwanda between 2005 and 2010 is deeply concerning, and further investigations of reasons for this increase are urgently needed. This study summarizes trends, correlates, and broad hypotheses for IPV, however, the cross-sectional nature of the DHS does not allow us to draw causal conclusions about predictors or consequences of IPV. Furthermore, measurement of physical and sexual IPV in household surveys is subject to under-reporting due to interviewer traits and difficulty securing privacy in smaller, densely populated homes . We findAbunzi mediators are able to address IPV should be investigated. Campaigns that involve men and women in redefining gender roles could be an important contribution to the gender equality agenda moving forward in Rwanda, and the effects of these campaigns on IPV and IPV perceptions should be systematically evaluated.The 2015 DHS was recently completed but not released at the time of this writing, and results from that survey might provide important insight about trends in IPV. Preliminary results of the 2015 DHS indicate continued rapid economic development in Rwanda, which is expected to correlate with a drop in IPV , 17. We Rwanda has one of the highest self-reported rates of intimate partner violence against women worldwide, and multiple forms of current or past violence are reported by the same women. Doubling in self-reported violence between 2005 and 2010 coincided with major political and social gains. While the Rwandan health and legal sectors have multiple initiatives to support victims, additional campaigns may be needed to shift public perception and perpetration of intimate partner violence. The impact of these programs, and changes in reported violence, need further investigation."]}
{"representative": "The adverse relationship between income and health is well documented, but less is known of how income trajectories, i.e. downward or upward trends in income, determine health. We therefore link longitudinal income information to cross-sectional data on self-rated health and conduct logistic regression models in order to investigate income trends over time and their relationship with health.The data, with the exception of income information, are derived from the Swedish Level-of-Living Survey 2000. The information on income was drawn from the income register covering the period 1995 to 2000. We used an age-restricted sample of those 30\u201364 years of age, and generated a series of models accounting for average income position, lagged income position, income decrease and increase, and annual periods in specific income positions. The analysis was conducted for men and women separately.Apart from the overall association between income and health, we found a similar pattern when including average and lagged income in the model. The analysis of length of time in a specific income position showed substantial sex differences in poor health. Income decrease was more strongly associated with men\u2019s poor health, whereas income increase revealed only weak associations with self-rated health.It was shown that income changes and the time dimension of income are important for self-rated health. Self-rated health responds to decreases in absolute income and lowered rank position in the income distribution to a greater extent than to income gains over time. Lagged lower income position and its associations with health suggest that socio-economic disadvantages accumulate over time. Extensive research has been dedicated to demonstrating the adverse health consequences of low income position; however, much less attention has been paid to income dynamics and lagged effects of income. The priResearch on income inequalities in health has mainly focused on the income-specific mechanisms involved in the relationship, such as absolute income mainly drawing on material resources or relative income addressing non-material aspects and social comparisons\u20135. In reEarlier studies have almost consistently shown that increasing income is more beneficial for health than falling income. The extPrevious literature is not particularly clear about the causal mechanisms involved in the complex of income change and health. However, earlier research has revealed that the discontinuation of specific aspects in people\u2019s life (like the disruption of access to resources) and certain events can trigger health problems and deteriorate well-being. In this respect, falling income evokes a frustrating experience that might initially trigger stress reactions. In the long run, a fall in income is accompanied by material shortages and less purchasing power, the loss of social integration and feelings of deprivation, which might also lead to health problems such as distress, 11.The health implications of income increase appear to be ambiguous. Looking at previous studies, there is no consistent proof that income increase entails health improvements. Obviously, higher income increases the ability to consume, but it must be questioned to what extent this can be converted into better health. Depending on individual priorities, additional income can be invested in healthy food and lifestyle or health care, but also in consumption goods and hazardous activities, which in turn might deteriorate one\u2019s health.A further question concerns the role of contextual conditions, like welfare provisions, which are able to mitigate the consequences of low income, income loss, unemployment, poverty and related economic hardships. Regarding low income position and poverty, it has often been argued that these conditions are less severe in the Swedish context since Sweden has a relatively generous welfare system that provides comprehensive social security, parachuting basically everyone in society.per se contribute to social inequalities in health. The specific aim of this paper then is to explore short and longer-term consequences of individual income position on health in Sweden, and further, to account for income variations over a six-year period by combining longitudinal income information with self-rated health from a cross-sectional survey. In a somewhat explorative approach, different modeling strategies are used in order to identify income developments in terms of both changes and stability over time. The proposed analysis distinguishes between health effects due to income level and income change by adding the respective covariates that distinguish the two dimensions. Of particular interest is the extent to which income changes affect people\u2019s health in their respective income position; whether income changes have similar health consequences for those in low and high income groups. Further, enduring low-income position and its health consequences will be tested.The present study hypothesizes that the individual\u2019s current income situation is crucial for health, and further that income changes The data for this study were derived from the Swedish Level-of-Living Survey (LNU), using the latest available cross-section with data from the year 2000 comprising a total sample of 5,142 individuals. The croWith respect to the quasi cross-sectional data and the categorical nature of the variables of interest, the analysis was conducted using logistic regression. In one of the analytical models, OLS regression was additionally applied. All calculations were performed in Stata 11. An age-restricted sample of persons between 30 and 64\u00a0years was used to capture those mainly receiving working income. The income pooled sample size thus covered about 3,377 individuals. All models were adjusted for age of years of the respondents.The health measure used in this study was self-rated health (SRH). The reliability and applicability of this measure has been frequently discussed, 14. TheLike SRH, information on the individual\u2019s educational attainment was derived from the LNU cross-section. The level of education an individual attains can be regarded as reliable indicator of later socio-economic position. Because educational degrees remain relatively stable throughout the life course, the use of education as a covariate may reduce the effects of social selection and reverse causality between income and health in the presented analysis. The education variable reflects highest attainment and was categorized into \u201cprimary/no degree\u201d, \u201csecondary\u201d and \u201cpost-secondary\u201d levels.Length of time below median incomeTo measure enduring low income, a variable was created that considers the number of years in the income position below the income median. The median was calculated separately for each calendar year. This covariate consists of seven categories, ranging from \u201cnever\u201d (0\u00a0years) below median up to a maximum of six years with below-median income.The modeling of income change and income stability was based on the pooled income information we obtained for the years 1995 to 2000. The income quintiles were calculated on the basis of the mean income over time and considered the income distribution of the total sample. Because the using sample was age-restricted and stratified by sex, the initially coded income quintiles resulted in unevenly distributed income groups. In addition, a set of income-based covariates was generated to assess income changes over time, to explore whether changes in income position or absolute income were important.(2)Changes in the rank position in the income distributionChanges in income position were analyzed by considering the variations of income position between 1995 and 2000. Relative income position was assessed by creating income percentiles, which gave 100 income subgroups of equal size. The calculation of percentiles was based on the total sample for which income information was available. The income percentiles for the period 1995 to 2000 were then used to trace changes in the rank position in the income distribution over time. First, all changes were tracked by calculating the difference in percentiles of income between the current and the preceding income year . In the next step, a variable was created which kept all substantial changes and non-changes. This variable consisted of four distinct categories and considered all changes with more than ten percentiles from one year to another. The reference category included all those in the sample with a stable income . In the second category, all those without income increase were included (i.e. those who experienced periods with stable income in combination with income decrease). The third category captured those without income decrease (i.e. with stable income in combination with income increase). The fourth category included all others (i.e. those without a particular trend during the considered period). This group, labeled as \u201cinconsistent\u201d, included all subjects who had not only periods of income increase and decrease but also stable income periods.(3)Relative changes in absolute incomeIn order to assess the relative changes in the nominal amount of income, we explored how a relative change with amplitudes of more than ten percent (+/- 10%) in absolute income affected the health outcome. We chose this approach to test the extent to which a substantial income change in relation to the income level would affect the health outcome. In this approach we took into account that an income change \u2013 particularly loss of income \u2013 has different meaning and consequences for those in higher or lower income positions likely with less severe consequences for those with high income.Similar to the approach in changes in the rank position, four distinct groups with income developments over time were specified. The reference group included all those with stable income. The second category captured those without income increase. The third category accounts for individuals without income decrease, and the fourth, labeled as \u201cinconsistent\u201d, subsumed all others with downward and upward income changes during the observation period.(4)Regression based slopesFinally, income trends over time were assessed through the slopes of linear regression. Regression slopes were calculated for each individual capturing the income developments between 1995 and 2000. The obtained b-coefficient of the slope then was recoded into a five-fold ordinal variable, reflecting the following categories: \u201cstrong decrease\u201d, \u201cweak decrease\u201d, \u201cstable income\u201d, \u201cweak increase\u201d and \u201cstrong increase\u201d.The slope extrapolates income development and reflects the individual income trends in a very crude way. A strong increase then corresponds to a gain of more than 10,000 SEK, weak increase between 10,000 and 1,000 SEK. Stable income was defined as the range between 1,000 and -1,000 SEK. Weak and strong decrease mirrored the threshold for income increase. Analogue to income increase, income decreases were defined as \u201cstrong\u201d when income dropped with more than 10,000 SEK and as \u201cweak\u201d for losses between 1,000 and 10,000 SEK over time.An overview of the distribution of the variables, the prevalence of poor health and levels of absolute disposable mean income during the observation period are shown in Table\u00a0In Model 1 Table we exploModel 2 Tables and4 shIn Model 3 the relative change in income position was explored. The analysis reveals that a substantial downward change in relative income position increases the risk for poor health \u2013 stronger for men than for women. Income loss combined with stable income showed increased ORs for both men  and women  compared to the reference category. The gender differences are even more pronounced for income increase. Men with at least one period of income increase have an 81 percent higher risk of ending up in poor SRH compared to the reference group. The estimates for women in the same category, however, reveal the opposite association, although the results are non-significant . In the mixed category of \u201cinconsistent\u201d income, we detect an increase in odds of poor health for men by 61 percent and a non-significant increase for women by 32 percent.Model 4 shows the changes in income based on absolute income, i.e. the nominal amount of income a person received. Income loss in combination with stable income reveals the same estimate for men as shown in Model 3 . Increased odds ratios for poor health are also found for women . The estimates for income increase are slightly below the reference category, but non-significant. In contrast to Model 3, inconsistent income does not reveal a significant association with poor SRH for men, but a notable though non-significant estimate for women.The results based on the individual income slopes are shown in Model 5. The estimates somewhat contradict the findings from Model 3 and 4. The analysis of the male sample demonstrates a significant gradient between income trends and health, although the single estimates remain non-significant. The estimates shown for women suggest a U-shaped association between income trends and health. Increases in income are significantly associated with better health. In addition, Model 5 shows the linear gradient for the association of income slopes and SRH. When collapsing the five categories into a single estimate, a significant association between the steepness of the income trajectories for men and women is observed.The aim of this study was to explore income changes and their relevance for subsequent self-rated health, by implementing income histories based on register records into a cross-sectional survey. The type of analysis we presented in this study was restricted by a cross-sectional design, with variables accounting for various types of income development over time and length in a specific income position. The cross-sectional nature of the used data and the characteristics of the variables determined the choice of analysis. We attempted to circumvent the static nature of cross-sectional analysis by including income histories that were recoded into categorical variables applicable for logistic regression. Generally, cross-sectional analysis underestimates the flexible nature of income and conceals that the aspect of time within the association between income and health might be potentially important.The first model revealed the lagging effect of prior low income which seems to determine the health outcome. Using an alternative cut-off point for the level of deprivation and cruder time intervals, Benzeval and Judge identifiIn a set of models, we accounted for short-term income change and income mobility within a six-year period and the subsequent outcomes for SRH. The modeling strategy distinguished between changes in absolute income and changes in the relative rank position in the income distribution, which led partially to fairly different results. Both approaches revealed that a substantial loss of income at one or more occasions during the past six income years is associated with an increased risk of poor health (more for men than for women). Inconsistent rank positions in the income distribution yielded increased estimates of poor SRH for men, whereas inconsistent absolute income disclosed a higher prevalence of poor SRH only among women. Counter-intuitive and somewhat paradoxical were the health implications of upward income for men when change in relative rank position was accounted for. The somewhat inconclusive findings resemble a previous study that explored changes in income over time by using an earlier wave of the same data: Lundberg and Fritzell found anIt is widely accepted that low income is risk factor for poor health. Evidence in previous research is mostly based on income inequality measured closest to health outcomes, but it is uncertain whether income affects only influence health instantaneously. The preThe study uses one income variable; however it was scaled in different ways throughout the presented analysis. The contrasting findings between absolute income and rank position indicate that the type of scaling used on the income variable is important with respect to the health outcome. For example, previous studies on the causal implications of income on health have shown that the method of scaling income may lead to different conclusions regarding health. The incThe overall income development in the study population may have influenced the presented results. In particular the findings based on absolute income follow the trends of the overall income development on the population-level. The findings based on relative rank measures, however, are less prone to fluctuations in income on the national level and are more influenced by changes in the income distribution. The compression of the income distribution affects the relative distances between lower and higher income groups and thus the rank positions in the income distribution, 29.Not to be downplayed, the rise and fall of individual income over time is primarily a consequence of preceding changes in the individual\u2019s employment and labor market position. In the presented analysis, confounding from employment status may have occurred and affected the findings because an appropriate control variable was not available in the data material. Previous studies adjusting the income-health relationship for employment showed that magnitudes in poor health become attenuated. HoweverThe data format and structure restricted the possibilities of data analysis in this study. The presented analyses proposed to enhance cross-sectional studies, but are nevertheless not powerful as true longitudinal time-series approaches. A shortcoming in the current study is the availability of the outcome measure at only one time-point during the observation period. For the same reason, an appropriate adjustment for socio-economic positions was impeded and relied on education alone. Thus, the temporal ordering of social position and health status cannot properly be determined. At least some of the findings may therefore be a result of reversed causality with health influencing income.The inconsistent and not always conclusive findings for women in this study may because women\u2019s income depends to some extent on that of their partner\u2019s socio-economic situation, 33. AlsIncome information may be biased due to an overall increase in income. However, as inflation in Sweden was comparably low during the observation period , its influence on the used income variables and results is presumed to be rather low.The lack of longitudinal information on control variables impeded investigation into the specific reasons for changes income. It is very likely that changes in income coincide with events like unemployment, family dissolution etc. which themselves explain variations in SRH.Although we were able to show that the income distribution is relatively stable over time and that income inequality did not change substantially during the considered period, individual income mobility did occur. Following individual income trajectories, we showed that individual income change is an important determinant for health. This holds true independent of level of income. Although we used relatively old data, covering the 1990s in Sweden, we still believe the results are relevant. Income inequality in Sweden has increased in the past decade, and has certainly affected the income-health relationship.The study showed that the dimension of time and thus the lagged effects of income should be considered when studying income inequality in health. In absence of reference data, the analytical design could not control for potential influences stemming from welfare reforms and retrenchments in the wake of the 1990\u2019s recession in Sweden. However, it was shown that loss of income is likely a threat for health while increases income revealed rather inconsistent results.Although this study could not identify a consistent pattern and clear direction of associations between income and self-rated health over time, it was shown that the time dimension matters. In particular income instability \u2013 in either upward or downward trends of income \u2013 show an adverse association with health.", "texts": ["The adverse relationship between income and health is well documented, but less is known of how income trajectories, i.e. downward or upward trends in income, determine health. We therefore link longitudinal income information to cross-sectional data on self-rated health and conduct logistic regression models in order to investigate income trends over time and their relationship with health.The data, with the exception of income information, are derived from the Swedish Level-of-Living Survey 2000. The information on income was drawn from the income register covering the period 1995 to 2000. We used an age-restricted sample of those 30\u201364 years of age, and generated a series of models accounting for average income position, lagged income position, income decrease and increase, and annual periods in specific income positions. The analysis was conducted for men and women separately.Apart from the overall association between income and health, we found a similar pattern when including average and lagged income in the model. The analysis of length of time in a specific income position showed substantial sex differences in poor health. Income decrease was more strongly associated with men\u2019s poor health, whereas income increase revealed only weak associations with self-rated health.It was shown that income changes and the time dimension of income are important for self-rated health. Self-rated health responds to decreases in absolute income and lowered rank position in the income distribution to a greater extent than to income gains over time. Lagged lower income position and its associations with health suggest that socio-economic disadvantages accumulate over time. Extensive research has been dedicated to demonstrating the adverse health consequences of low income position; however, much less attention has been paid to income dynamics and lagged effects of income. The priResearch on income inequalities in health has mainly focused on the income-specific mechanisms involved in the relationship, such as absolute income mainly drawing on material resources or relative income addressing non-material aspects and social comparisons\u20135. In reEarlier studies have almost consistently shown that increasing income is more beneficial for health than falling income. The extPrevious literature is not particularly clear about the causal mechanisms involved in the complex of income change and health. However, earlier research has revealed that the discontinuation of specific aspects in people\u2019s life (like the disruption of access to resources) and certain events can trigger health problems and deteriorate well-being. In this respect, falling income evokes a frustrating experience that might initially trigger stress reactions. In the long run, a fall in income is accompanied by material shortages and less purchasing power, the loss of social integration and feelings of deprivation, which might also lead to health problems such as distress, 11.The health implications of income increase appear to be ambiguous. Looking at previous studies, there is no consistent proof that income increase entails health improvements. Obviously, higher income increases the ability to consume, but it must be questioned to what extent this can be converted into better health. Depending on individual priorities, additional income can be invested in healthy food and lifestyle or health care, but also in consumption goods and hazardous activities, which in turn might deteriorate one\u2019s health.A further question concerns the role of contextual conditions, like welfare provisions, which are able to mitigate the consequences of low income, income loss, unemployment, poverty and related economic hardships. Regarding low income position and poverty, it has often been argued that these conditions are less severe in the Swedish context since Sweden has a relatively generous welfare system that provides comprehensive social security, parachuting basically everyone in society.per se contribute to social inequalities in health. The specific aim of this paper then is to explore short and longer-term consequences of individual income position on health in Sweden, and further, to account for income variations over a six-year period by combining longitudinal income information with self-rated health from a cross-sectional survey. In a somewhat explorative approach, different modeling strategies are used in order to identify income developments in terms of both changes and stability over time. The proposed analysis distinguishes between health effects due to income level and income change by adding the respective covariates that distinguish the two dimensions. Of particular interest is the extent to which income changes affect people\u2019s health in their respective income position; whether income changes have similar health consequences for those in low and high income groups. Further, enduring low-income position and its health consequences will be tested.The present study hypothesizes that the individual\u2019s current income situation is crucial for health, and further that income changes The data for this study were derived from the Swedish Level-of-Living Survey (LNU), using the latest available cross-section with data from the year 2000 comprising a total sample of 5,142 individuals. The croWith respect to the quasi cross-sectional data and the categorical nature of the variables of interest, the analysis was conducted using logistic regression. In one of the analytical models, OLS regression was additionally applied. All calculations were performed in Stata 11. An age-restricted sample of persons between 30 and 64\u00a0years was used to capture those mainly receiving working income. The income pooled sample size thus covered about 3,377 individuals. All models were adjusted for age of years of the respondents.The health measure used in this study was self-rated health (SRH). The reliability and applicability of this measure has been frequently discussed, 14. TheLike SRH, information on the individual\u2019s educational attainment was derived from the LNU cross-section. The level of education an individual attains can be regarded as reliable indicator of later socio-economic position. Because educational degrees remain relatively stable throughout the life course, the use of education as a covariate may reduce the effects of social selection and reverse causality between income and health in the presented analysis. The education variable reflects highest attainment and was categorized into \u201cprimary/no degree\u201d, \u201csecondary\u201d and \u201cpost-secondary\u201d levels.Length of time below median incomeTo measure enduring low income, a variable was created that considers the number of years in the income position below the income median. The median was calculated separately for each calendar year. This covariate consists of seven categories, ranging from \u201cnever\u201d (0\u00a0years) below median up to a maximum of six years with below-median income.The modeling of income change and income stability was based on the pooled income information we obtained for the years 1995 to 2000. The income quintiles were calculated on the basis of the mean income over time and considered the income distribution of the total sample. Because the using sample was age-restricted and stratified by sex, the initially coded income quintiles resulted in unevenly distributed income groups. In addition, a set of income-based covariates was generated to assess income changes over time, to explore whether changes in income position or absolute income were important.(2)Changes in the rank position in the income distributionChanges in income position were analyzed by considering the variations of income position between 1995 and 2000. Relative income position was assessed by creating income percentiles, which gave 100 income subgroups of equal size. The calculation of percentiles was based on the total sample for which income information was available. The income percentiles for the period 1995 to 2000 were then used to trace changes in the rank position in the income distribution over time. First, all changes were tracked by calculating the difference in percentiles of income between the current and the preceding income year . In the next step, a variable was created which kept all substantial changes and non-changes. This variable consisted of four distinct categories and considered all changes with more than ten percentiles from one year to another. The reference category included all those in the sample with a stable income . In the second category, all those without income increase were included (i.e. those who experienced periods with stable income in combination with income decrease). The third category captured those without income decrease (i.e. with stable income in combination with income increase). The fourth category included all others (i.e. those without a particular trend during the considered period). This group, labeled as \u201cinconsistent\u201d, included all subjects who had not only periods of income increase and decrease but also stable income periods.(3)Relative changes in absolute incomeIn order to assess the relative changes in the nominal amount of income, we explored how a relative change with amplitudes of more than ten percent (+/- 10%) in absolute income affected the health outcome. We chose this approach to test the extent to which a substantial income change in relation to the income level would affect the health outcome. In this approach we took into account that an income change \u2013 particularly loss of income \u2013 has different meaning and consequences for those in higher or lower income positions likely with less severe consequences for those with high income.Similar to the approach in changes in the rank position, four distinct groups with income developments over time were specified. The reference group included all those with stable income. The second category captured those without income increase. The third category accounts for individuals without income decrease, and the fourth, labeled as \u201cinconsistent\u201d, subsumed all others with downward and upward income changes during the observation period.(4)Regression based slopesFinally, income trends over time were assessed through the slopes of linear regression. Regression slopes were calculated for each individual capturing the income developments between 1995 and 2000. The obtained b-coefficient of the slope then was recoded into a five-fold ordinal variable, reflecting the following categories: \u201cstrong decrease\u201d, \u201cweak decrease\u201d, \u201cstable income\u201d, \u201cweak increase\u201d and \u201cstrong increase\u201d.The slope extrapolates income development and reflects the individual income trends in a very crude way. A strong increase then corresponds to a gain of more than 10,000 SEK, weak increase between 10,000 and 1,000 SEK. Stable income was defined as the range between 1,000 and -1,000 SEK. Weak and strong decrease mirrored the threshold for income increase. Analogue to income increase, income decreases were defined as \u201cstrong\u201d when income dropped with more than 10,000 SEK and as \u201cweak\u201d for losses between 1,000 and 10,000 SEK over time.An overview of the distribution of the variables, the prevalence of poor health and levels of absolute disposable mean income during the observation period are shown in Table\u00a0In Model 1 Table we exploModel 2 Tables and4 shIn Model 3 the relative change in income position was explored. The analysis reveals that a substantial downward change in relative income position increases the risk for poor health \u2013 stronger for men than for women. Income loss combined with stable income showed increased ORs for both men  and women  compared to the reference category. The gender differences are even more pronounced for income increase. Men with at least one period of income increase have an 81 percent higher risk of ending up in poor SRH compared to the reference group. The estimates for women in the same category, however, reveal the opposite association, although the results are non-significant . In the mixed category of \u201cinconsistent\u201d income, we detect an increase in odds of poor health for men by 61 percent and a non-significant increase for women by 32 percent.Model 4 shows the changes in income based on absolute income, i.e. the nominal amount of income a person received. Income loss in combination with stable income reveals the same estimate for men as shown in Model 3 . Increased odds ratios for poor health are also found for women . The estimates for income increase are slightly below the reference category, but non-significant. In contrast to Model 3, inconsistent income does not reveal a significant association with poor SRH for men, but a notable though non-significant estimate for women.The results based on the individual income slopes are shown in Model 5. The estimates somewhat contradict the findings from Model 3 and 4. The analysis of the male sample demonstrates a significant gradient between income trends and health, although the single estimates remain non-significant. The estimates shown for women suggest a U-shaped association between income trends and health. Increases in income are significantly associated with better health. In addition, Model 5 shows the linear gradient for the association of income slopes and SRH. When collapsing the five categories into a single estimate, a significant association between the steepness of the income trajectories for men and women is observed.The aim of this study was to explore income changes and their relevance for subsequent self-rated health, by implementing income histories based on register records into a cross-sectional survey. The type of analysis we presented in this study was restricted by a cross-sectional design, with variables accounting for various types of income development over time and length in a specific income position. The cross-sectional nature of the used data and the characteristics of the variables determined the choice of analysis. We attempted to circumvent the static nature of cross-sectional analysis by including income histories that were recoded into categorical variables applicable for logistic regression. Generally, cross-sectional analysis underestimates the flexible nature of income and conceals that the aspect of time within the association between income and health might be potentially important.The first model revealed the lagging effect of prior low income which seems to determine the health outcome. Using an alternative cut-off point for the level of deprivation and cruder time intervals, Benzeval and Judge identifiIn a set of models, we accounted for short-term income change and income mobility within a six-year period and the subsequent outcomes for SRH. The modeling strategy distinguished between changes in absolute income and changes in the relative rank position in the income distribution, which led partially to fairly different results. Both approaches revealed that a substantial loss of income at one or more occasions during the past six income years is associated with an increased risk of poor health (more for men than for women). Inconsistent rank positions in the income distribution yielded increased estimates of poor SRH for men, whereas inconsistent absolute income disclosed a higher prevalence of poor SRH only among women. Counter-intuitive and somewhat paradoxical were the health implications of upward income for men when change in relative rank position was accounted for. The somewhat inconclusive findings resemble a previous study that explored changes in income over time by using an earlier wave of the same data: Lundberg and Fritzell found anIt is widely accepted that low income is risk factor for poor health. Evidence in previous research is mostly based on income inequality measured closest to health outcomes, but it is uncertain whether income affects only influence health instantaneously. The preThe study uses one income variable; however it was scaled in different ways throughout the presented analysis. The contrasting findings between absolute income and rank position indicate that the type of scaling used on the income variable is important with respect to the health outcome. For example, previous studies on the causal implications of income on health have shown that the method of scaling income may lead to different conclusions regarding health. The incThe overall income development in the study population may have influenced the presented results. In particular the findings based on absolute income follow the trends of the overall income development on the population-level. The findings based on relative rank measures, however, are less prone to fluctuations in income on the national level and are more influenced by changes in the income distribution. The compression of the income distribution affects the relative distances between lower and higher income groups and thus the rank positions in the income distribution, 29.Not to be downplayed, the rise and fall of individual income over time is primarily a consequence of preceding changes in the individual\u2019s employment and labor market position. In the presented analysis, confounding from employment status may have occurred and affected the findings because an appropriate control variable was not available in the data material. Previous studies adjusting the income-health relationship for employment showed that magnitudes in poor health become attenuated. HoweverThe data format and structure restricted the possibilities of data analysis in this study. The presented analyses proposed to enhance cross-sectional studies, but are nevertheless not powerful as true longitudinal time-series approaches. A shortcoming in the current study is the availability of the outcome measure at only one time-point during the observation period. For the same reason, an appropriate adjustment for socio-economic positions was impeded and relied on education alone. Thus, the temporal ordering of social position and health status cannot properly be determined. At least some of the findings may therefore be a result of reversed causality with health influencing income.The inconsistent and not always conclusive findings for women in this study may because women\u2019s income depends to some extent on that of their partner\u2019s socio-economic situation, 33. AlsIncome information may be biased due to an overall increase in income. However, as inflation in Sweden was comparably low during the observation period , its influence on the used income variables and results is presumed to be rather low.The lack of longitudinal information on control variables impeded investigation into the specific reasons for changes income. It is very likely that changes in income coincide with events like unemployment, family dissolution etc. which themselves explain variations in SRH.Although we were able to show that the income distribution is relatively stable over time and that income inequality did not change substantially during the considered period, individual income mobility did occur. Following individual income trajectories, we showed that individual income change is an important determinant for health. This holds true independent of level of income. Although we used relatively old data, covering the 1990s in Sweden, we still believe the results are relevant. Income inequality in Sweden has increased in the past decade, and has certainly affected the income-health relationship.The study showed that the dimension of time and thus the lagged effects of income should be considered when studying income inequality in health. In absence of reference data, the analytical design could not control for potential influences stemming from welfare reforms and retrenchments in the wake of the 1990\u2019s recession in Sweden. However, it was shown that loss of income is likely a threat for health while increases income revealed rather inconsistent results.Although this study could not identify a consistent pattern and clear direction of associations between income and self-rated health over time, it was shown that the time dimension matters. In particular income instability \u2013 in either upward or downward trends of income \u2013 show an adverse association with health."]}
{"representative": "Intimate Partner Violence (IPV) has serious negative health effects to millions of women around the globe. While disclosing IPV could open doors for support and eventually prevent partner abuse, the factors associated with IPV disclosure during pregnancy are not well known. The aim of this study was to examine factors influencing IPV disclosure to any person of interest or organization supporting women during pregnancy in Moshi Municipality, Tanzania.Data were from a prospective cohort study of 1123 pregnant women followed-up by the project aiming to assess the impact of violence in the reproductive health conducted in Moshi Municipality, Tanzania from March 2014 to May 2015. Inclusion criteria to the current analysis were all 339 pregnant women who reported to have experienced physical, sexual and/or emotional violence during the index pregnancy. Data analysis used SPSS Version 20. Odds ratio with 95\u00a0% Confidence Interval (CI) for factors associated with IPV disclosure was estimated using multivariate logistic regression models while controlling for age, education and parity. A p-value of less than 0.05 was considered for a statistically significant difference.n\u2009=\u200979). Disclosure of IPV was less likely among unemployed  and women whose index pregnancy was unplanned . Women who regularly participated in women\u2019s or community groups, religious groups or political associations at least once a month had 2 times higher odds of IPV disclosure compared to those who did not attend regularly . Most of the abused women during pregnancy who disclosed their experience of IPV (69\u00a0%) disclosed to a member of the family of birth followed by friends (14\u00a0%) and a member of family of the partner (11\u00a0%).IPV disclosure was found to be 23.3\u00a0%  disclosed their experience to someone. Identification of the women experiencing IPV during pregnancy should be done as a starting point for supporting victim of IPV. Women empowerment in economical and reproductive health will reduce their vulnerability and facilitate disclosure of IPV for support. Key individuals who informally support victims of IPV should be targeted in interventions.The online version of this article (doi:10.1186/s12889-016-3345-x) contains supplementary material, which is available to authorized users. Intimate partner violence (IPV) is a serious public health problem globally. IPV is the most common type of violence against women perpetuated by men and estimated to be around 30\u00a0% globally . IPV preIPV disclosure may result into positive impacts to the victims if the process of disclosure is taken care well. The reported positive impacts of IPV disclosure include stop of further violence, safety of pregnant women and their pregnancy and assisting in the creation of new interventions towards violence , 9. AlsoDespite the high prevalence of IPV to the general population and during pregnancy, disclosure of IPV experience has remained low globally. Studies that tried to explore IPV disclosure have estimated to happen among 4 to 8\u00a0% globally , 8.8\u00a0% iThis study was carried out within a larger study titled \u201cThe Impact of Violence on Reproductive Health in Tanzania and Vietnam (PAVE)\u201d. The study was a prospective cohort and recruited a total of 1123 pregnant women when they were attending antenatal care in two health care facilities in Moshi District \u2013Tanzania from March 2014 to May 2015. Women who fulfilled the inclusion criteria were enrolled in the study, interviewed at baseline and followed up at 34\u00a0weeks gestation for the second interview. Only women with singleton pregnancy, at gestational age below 24\u00a0weeks based on ultrasound scan and willing to be followed up for the entire period of the study were enrolled in the study.Swahili language.After consenting participation, first interview was conducted using questionnaire to capture baseline socio-demographic and reproductive health characteristics of the participants\u00a0, reproductive history  and health risk behavior of alcohol consumption during pregnancy. Detailed social characteristics were inquired and included place of growth (this community or another community), living close to the family of birth and/or the family of the partner (yes/no), frequency of talking to a member of family of birth and/or of the partner  and whether they counted support from family of birth and/or of the partner in case of problems (yes/no). Socialization was also inquired as to whether they participated in women\u2019s or community groups, religious groups or political associations at least once a month (yes/no).Data were analyzed using Statistical Package for social Sciences . Descriptive statistics including frequency and proportion for baseline characteristics were done. On bivariate analysis, socio-demographic and reproductive health characteristics among those who did or did not disclose were compared using odds ratio (ORs) with 95\u00a0% confidence interval (CIs). Multivariate logistic regression analysis was done by including all factors which were significant in the bivariate logistic regression analysis to determine the most significant factors for IPV disclosure and also control for confounders. A factor was considered a confounder when a change to crude OR after adjustment was 10\u00a0% or more. P-value of less than 0.05 was considered for a statistical significant difference.The mean age of participants was 26\u00a0years (Standard deviation SD\u2009=\u20095.8\u00a0years). Their age ranged from 18 to 44\u00a0years. The overall characteristics of respondents are displayed in Table\u00a0As shown in Table\u00a0Over one third (35.4\u00a0%) of women would never depend on support from a member of family of the partner as compared to nearly a quarter 82 (23.2\u00a0%) who did the same to a member of the family of birth. Most of the participants in the study 282 (83.2\u00a0%) were not attending any support group or organizations.Out of 339 pregnant women who experienced any form of IPV, 79 (23.3\u00a0%) reported to have disclosed IPV to someone. As Table\u00a0Table\u00a0Results of adjusted analysis in Table Disclosure pattern is as displayed in Fig.\u00a0This study aimed at examining factors influencing disclosure of IPV experienced by women during pregnancy in Moshi Municipality, Tanzania. To the best of our knowledge, this is the first study in low income countries to determine factors influencing disclosure of IPV abuse during pregnancy in a longitudinal study and at a primary health care setting.The key findings of this study indicate that, less than a quarter (23\u00a0%) of all women who were exposed to physical, sexual and/or emotional abuse during pregnancy disclosed their experience and the rest kept suffering in silence. IPV disclosure was less likely among women who were unemployed and with unplanned pregnancy. Participation in women\u2019s or community groups, religious groups or political associations facilitated IPV disclosure. Abused women during pregnancy preferred to disclose IPV to members of family of origin followed by friends and to the family of in-laws.This study found that IPV disclosure is very low. Tanzania Demographic Health Survey (TDHS) 2010 , 10. InfLow level of IPV disclosure could be due to African kingship system, cultural and religious background where family issues are not expected to be exposed outside the marriage/relationships. Women are expected to be submissive to their husbands and disclosing information related to violence outside marriage/relationship is seen as immoral . On the This study revealed that women who were unemployed were less likely to disclose their experience of IPV compared to women who were employed. Pregnant woman who depend on their partner for economic support fail to disclose because the partner may, as a consequence, refuse to support them. In many instances, unemployment is determined by education level and in such cases, education remains as a pro factor to employment. Although education was not significantly associated with IPV disclosure in our study, its link to employment and IPV disclosure cannot be overlooked. Studies have shown that educated women feels more safe, confident and protected when compared to those who are less educated . In addiAccording to previous studies, other factors which influence IPV disclosure are nature/type of the IPV, severity of IPV, having children, personal factors and normalizing violence experiences as an expression of love , 21, 22.This study further revealed that participants who attended women\u2019s organizations were more likely to disclose compare to those who did not attend. The reasons here could be because those who attend organizations are more likely to be exposed to others who might have experienced IPV. They may be encouraged by others to share their life challenges and therefore contribute to the likelihood of IPV disclosure. On the other hand, most of women associations are geared towards economic empowerment and therefore decreasing women vulnerability from economic dependency to their partners , 24.Victims of abuse preferred to disclose their IPV status to a member of the family of origin compared to a member of the family of partner. The majority of women who experienced IPV in this study relied on the informal networks as their first point of contact rather than formal services. Similar pattern of IPV disclosure was reported previously . It coulNearly three quarter of the participants had disclosed IPV to the family of origin. Majority of them preferred their parents, followed by their brothers or sister and uncle or aunt. These findings are similar to the study done in Nigeria where larger proportions of participants (68\u00a0%) were willing to disclose their IPV status to the family . The plaFamily of the in-laws could play a very significant role to end IPV because of the feeling that it is easy for the parents to face their son. But the situation was different from this study as only 11\u00a0% disclosed to the family of in-laws. In African settings, a woman is seen by the in-laws as someone respected. This may hinder victims from facing the in-law to disclose IPV .. One reason for less likelihood of disclosing to institutions would be that they are more formal and women are not sure of what formal action/measures will be taken to stop further violence once they disclose IPV. Primary focus of abused women is bringing back peace in the relationship and the least they would want is family breakdown. This may be the case if men decide to react when appropriate actions are taken to them as perpetrators [Less than one in ten participants had disclosed to police, counselor, NGO/women\u2019s organization or local leaders while in Nigeria, 26\u00a0% of women exposed to IPV disclosed to formal institutions . Formal etrators . TherefoHealth-care providers are in a unique position to create a safe and confidential environment for facilitating disclosure of violence, while offering appropriate support and referral to other resources and services . One docThe study relied on secondary data which made it difficult to clarify missing information with participants. Violence being among the sensitive topics, interviewed participants may have with-held information or provided socially desirable answers to avoid being deviant to their culture or religious beliefs.The disclosure of IPV is complex. The findings presented in this study have shown that very low proportions of women who experienced IPV during pregnancy disclosed their experience. Factors for IPV disclosure includes occupation, planned pregnancy and attending group organization or association. We have also observed that majority of women prefer to disclose to their family of origin. Since disclosure is important for setting up interventions to support victims of IPV, findings of this study need to be used to provide important background for interventions that aim at encouraging IPV disclosure and support of victims of IPV. Patterns of disclosure show that members of family of origin and of the partner are preferred by women who share their IPV experience. Therefore, parents and other family member need to be equipped with knowledge on IPV and proper ways to assist IPV victims after disclosure. Family based violence counseling strategies are imperative. Because discloser to the formal institution is very low, these institutions should be equipped to play their role in address IPV in collaboration with informal networks. For pregnant women to be supported well and in a comprehensive way, identifying women who need support should be done and antenatal care could be the best place to start. Further research is needed to explore how informal institutions are effective in addressing the problem of IPV and in helping victims of IPV.CI, confidence interval; DANIDA, Danish international development agency; HIV, human immunodeficiency virus; IPV, intimate partner violence; NGO, non-governmental organization; OR, odds ratio; SD, standard deviation; SPSS, statistical package for social sciences; TDHS, Tanzania demographic health survey; WHO, World Health Organisation", "texts": ["Intimate Partner Violence (IPV) has serious negative health effects to millions of women around the globe. While disclosing IPV could open doors for support and eventually prevent partner abuse, the factors associated with IPV disclosure during pregnancy are not well known. The aim of this study was to examine factors influencing IPV disclosure to any person of interest or organization supporting women during pregnancy in Moshi Municipality, Tanzania.Data were from a prospective cohort study of 1123 pregnant women followed-up by the project aiming to assess the impact of violence in the reproductive health conducted in Moshi Municipality, Tanzania from March 2014 to May 2015. Inclusion criteria to the current analysis were all 339 pregnant women who reported to have experienced physical, sexual and/or emotional violence during the index pregnancy. Data analysis used SPSS Version 20. Odds ratio with 95\u00a0% Confidence Interval (CI) for factors associated with IPV disclosure was estimated using multivariate logistic regression models while controlling for age, education and parity. A p-value of less than 0.05 was considered for a statistically significant difference.n\u2009=\u200979). Disclosure of IPV was less likely among unemployed  and women whose index pregnancy was unplanned . Women who regularly participated in women\u2019s or community groups, religious groups or political associations at least once a month had 2 times higher odds of IPV disclosure compared to those who did not attend regularly . Most of the abused women during pregnancy who disclosed their experience of IPV (69\u00a0%) disclosed to a member of the family of birth followed by friends (14\u00a0%) and a member of family of the partner (11\u00a0%).IPV disclosure was found to be 23.3\u00a0%  disclosed their experience to someone. Identification of the women experiencing IPV during pregnancy should be done as a starting point for supporting victim of IPV. Women empowerment in economical and reproductive health will reduce their vulnerability and facilitate disclosure of IPV for support. Key individuals who informally support victims of IPV should be targeted in interventions.The online version of this article (doi:10.1186/s12889-016-3345-x) contains supplementary material, which is available to authorized users. Intimate partner violence (IPV) is a serious public health problem globally. IPV is the most common type of violence against women perpetuated by men and estimated to be around 30\u00a0% globally . IPV preIPV disclosure may result into positive impacts to the victims if the process of disclosure is taken care well. The reported positive impacts of IPV disclosure include stop of further violence, safety of pregnant women and their pregnancy and assisting in the creation of new interventions towards violence , 9. AlsoDespite the high prevalence of IPV to the general population and during pregnancy, disclosure of IPV experience has remained low globally. Studies that tried to explore IPV disclosure have estimated to happen among 4 to 8\u00a0% globally , 8.8\u00a0% iThis study was carried out within a larger study titled \u201cThe Impact of Violence on Reproductive Health in Tanzania and Vietnam (PAVE)\u201d. The study was a prospective cohort and recruited a total of 1123 pregnant women when they were attending antenatal care in two health care facilities in Moshi District \u2013Tanzania from March 2014 to May 2015. Women who fulfilled the inclusion criteria were enrolled in the study, interviewed at baseline and followed up at 34\u00a0weeks gestation for the second interview. Only women with singleton pregnancy, at gestational age below 24\u00a0weeks based on ultrasound scan and willing to be followed up for the entire period of the study were enrolled in the study.Swahili language.After consenting participation, first interview was conducted using questionnaire to capture baseline socio-demographic and reproductive health characteristics of the participants\u00a0, reproductive history  and health risk behavior of alcohol consumption during pregnancy. Detailed social characteristics were inquired and included place of growth (this community or another community), living close to the family of birth and/or the family of the partner (yes/no), frequency of talking to a member of family of birth and/or of the partner  and whether they counted support from family of birth and/or of the partner in case of problems (yes/no). Socialization was also inquired as to whether they participated in women\u2019s or community groups, religious groups or political associations at least once a month (yes/no).Data were analyzed using Statistical Package for social Sciences . Descriptive statistics including frequency and proportion for baseline characteristics were done. On bivariate analysis, socio-demographic and reproductive health characteristics among those who did or did not disclose were compared using odds ratio (ORs) with 95\u00a0% confidence interval (CIs). Multivariate logistic regression analysis was done by including all factors which were significant in the bivariate logistic regression analysis to determine the most significant factors for IPV disclosure and also control for confounders. A factor was considered a confounder when a change to crude OR after adjustment was 10\u00a0% or more. P-value of less than 0.05 was considered for a statistical significant difference.The mean age of participants was 26\u00a0years (Standard deviation SD\u2009=\u20095.8\u00a0years). Their age ranged from 18 to 44\u00a0years. The overall characteristics of respondents are displayed in Table\u00a0As shown in Table\u00a0Over one third (35.4\u00a0%) of women would never depend on support from a member of family of the partner as compared to nearly a quarter 82 (23.2\u00a0%) who did the same to a member of the family of birth. Most of the participants in the study 282 (83.2\u00a0%) were not attending any support group or organizations.Out of 339 pregnant women who experienced any form of IPV, 79 (23.3\u00a0%) reported to have disclosed IPV to someone. As Table\u00a0Table\u00a0Results of adjusted analysis in Table Disclosure pattern is as displayed in Fig.\u00a0This study aimed at examining factors influencing disclosure of IPV experienced by women during pregnancy in Moshi Municipality, Tanzania. To the best of our knowledge, this is the first study in low income countries to determine factors influencing disclosure of IPV abuse during pregnancy in a longitudinal study and at a primary health care setting.The key findings of this study indicate that, less than a quarter (23\u00a0%) of all women who were exposed to physical, sexual and/or emotional abuse during pregnancy disclosed their experience and the rest kept suffering in silence. IPV disclosure was less likely among women who were unemployed and with unplanned pregnancy. Participation in women\u2019s or community groups, religious groups or political associations facilitated IPV disclosure. Abused women during pregnancy preferred to disclose IPV to members of family of origin followed by friends and to the family of in-laws.This study found that IPV disclosure is very low. Tanzania Demographic Health Survey (TDHS) 2010 , 10. InfLow level of IPV disclosure could be due to African kingship system, cultural and religious background where family issues are not expected to be exposed outside the marriage/relationships. Women are expected to be submissive to their husbands and disclosing information related to violence outside marriage/relationship is seen as immoral . On the This study revealed that women who were unemployed were less likely to disclose their experience of IPV compared to women who were employed. Pregnant woman who depend on their partner for economic support fail to disclose because the partner may, as a consequence, refuse to support them. In many instances, unemployment is determined by education level and in such cases, education remains as a pro factor to employment. Although education was not significantly associated with IPV disclosure in our study, its link to employment and IPV disclosure cannot be overlooked. Studies have shown that educated women feels more safe, confident and protected when compared to those who are less educated . In addiAccording to previous studies, other factors which influence IPV disclosure are nature/type of the IPV, severity of IPV, having children, personal factors and normalizing violence experiences as an expression of love , 21, 22.This study further revealed that participants who attended women\u2019s organizations were more likely to disclose compare to those who did not attend. The reasons here could be because those who attend organizations are more likely to be exposed to others who might have experienced IPV. They may be encouraged by others to share their life challenges and therefore contribute to the likelihood of IPV disclosure. On the other hand, most of women associations are geared towards economic empowerment and therefore decreasing women vulnerability from economic dependency to their partners , 24.Victims of abuse preferred to disclose their IPV status to a member of the family of origin compared to a member of the family of partner. The majority of women who experienced IPV in this study relied on the informal networks as their first point of contact rather than formal services. Similar pattern of IPV disclosure was reported previously . It coulNearly three quarter of the participants had disclosed IPV to the family of origin. Majority of them preferred their parents, followed by their brothers or sister and uncle or aunt. These findings are similar to the study done in Nigeria where larger proportions of participants (68\u00a0%) were willing to disclose their IPV status to the family . The plaFamily of the in-laws could play a very significant role to end IPV because of the feeling that it is easy for the parents to face their son. But the situation was different from this study as only 11\u00a0% disclosed to the family of in-laws. In African settings, a woman is seen by the in-laws as someone respected. This may hinder victims from facing the in-law to disclose IPV .. One reason for less likelihood of disclosing to institutions would be that they are more formal and women are not sure of what formal action/measures will be taken to stop further violence once they disclose IPV. Primary focus of abused women is bringing back peace in the relationship and the least they would want is family breakdown. This may be the case if men decide to react when appropriate actions are taken to them as perpetrators [Less than one in ten participants had disclosed to police, counselor, NGO/women\u2019s organization or local leaders while in Nigeria, 26\u00a0% of women exposed to IPV disclosed to formal institutions . Formal etrators . TherefoHealth-care providers are in a unique position to create a safe and confidential environment for facilitating disclosure of violence, while offering appropriate support and referral to other resources and services . One docThe study relied on secondary data which made it difficult to clarify missing information with participants. Violence being among the sensitive topics, interviewed participants may have with-held information or provided socially desirable answers to avoid being deviant to their culture or religious beliefs.The disclosure of IPV is complex. The findings presented in this study have shown that very low proportions of women who experienced IPV during pregnancy disclosed their experience. Factors for IPV disclosure includes occupation, planned pregnancy and attending group organization or association. We have also observed that majority of women prefer to disclose to their family of origin. Since disclosure is important for setting up interventions to support victims of IPV, findings of this study need to be used to provide important background for interventions that aim at encouraging IPV disclosure and support of victims of IPV. Patterns of disclosure show that members of family of origin and of the partner are preferred by women who share their IPV experience. Therefore, parents and other family member need to be equipped with knowledge on IPV and proper ways to assist IPV victims after disclosure. Family based violence counseling strategies are imperative. Because discloser to the formal institution is very low, these institutions should be equipped to play their role in address IPV in collaboration with informal networks. For pregnant women to be supported well and in a comprehensive way, identifying women who need support should be done and antenatal care could be the best place to start. Further research is needed to explore how informal institutions are effective in addressing the problem of IPV and in helping victims of IPV.CI, confidence interval; DANIDA, Danish international development agency; HIV, human immunodeficiency virus; IPV, intimate partner violence; NGO, non-governmental organization; OR, odds ratio; SD, standard deviation; SPSS, statistical package for social sciences; TDHS, Tanzania demographic health survey; WHO, World Health Organisation"]}
{"representative": "Intimate partner violence (IPV) is common worldwide and occurs across social, economic, religious and cultural groups. This makes it an important public health issue for health care providers. In South Africa, the problem of violence against women is complex and it has social and public health consequences. The paucity of data on IPV is related to underreporting and a lack of screening of this form of violence in health care settings.The aim of this study was to determine the prevalence of IPV and explore the risk factors associated with this type of violence against women who visited a public hospital in Botswana.A descriptive, cross-sectional survey was conducted among randomly sampled adult women aged 21 years and older, during their hospital visits in 2007. Data were obtained by means of structured interviews, after obtaining written and signed, informed consent from each participant.2 = 17.318; p = 0.001) and IPV, as well as cigarette smoking  and IPV.A total of 320 women participated in this study. Almost half (49.7%) reported having had an experience of IPV in one form or another at some point in their lifetime, while 68 (21.2%) reported a recent incident of abuse by their partners in the past year. Experiences of IPV were predominantly reported by women aged 21 \u2013 30 years . Most of the allegedly abused participants were single  and unemployed . Significant associations were found between alcohol use by participants\u2019 male intimate partners , especially among young adult women, but the prevalence of reported IPV is low (13.2%). It is essential that women are screened regularly in the country's public and private health care settings for IPV. IPV is sometimes referred to as domestic violence. The word \u2018violence\u2019 is also used interchangeably with \u2018abuse\u2019.4 This makes it an important public health issue for health care providers. Most of the time the abuse from IPV is hidden from the public's view and society remains uninformed of the nature and extent of such violence and abuse. Consequently, this form of violence and the extent of the problem cannot be directly observed.In South Africa, the problem of violence against women is complex and has social and public health consequences.5Of concern is the paucity of data on IPV due to \u2018underreporting\u2019 and \u2018lack of screening\u2019, which contributes to the complexity and the magnitude of this form of violence, especially against women. Furthermore, obtaining reliable data on IPV is a complicated and intricate task, because of the private and intimate context in which this form of violence and abuse often takes place and also because of methodological challenges imposed by the nature of such studies.6Research on violence against women is considered an important objective of any programme designed to eradicate this problem. At the fourth World Conference on Women held in Beijing in 1995, one of the strategic objectives established was to study the causes and consequences of violence against women and the efficacy of preventive measures, thus encouraging governments and organisations to promote research in this area.7 The objective of this study was to develop methodologies to measure violence against women and its health repercussions in different cultures.A World Health Organization's (WHO's) population-based survey on women's health and domestic violence against women in 2005 established that 10% \u2013 69% of women had been assaulted by their male intimate partners at some stage in their lives, and that 15% \u2013 30% had been assaulted in the previous year.4 In Africa, men are seen as the head of the marriage or relationship, which indirectly promotes either verbal or physical abuse towards their female partners.8 The latter has also been observed in Mochudi, a village in Botswana, which shares common socio-cultural features with other southern African countries.9Furthermore, the results of the WHO survey showed that the national lifetime prevalence of partner abuse among South African women was estimated at 13% and occurrence in the previous year at 11%. The Eastern Cape was found to have the highest lifetime prevalence of 27% and previous-year prevalence of 11%.10 and the recommendations prescribed in the ethical and safety guidelines for research on domestic violence.11 Written and signed informed consent was obtained from each participant prior to data collection. Special arrangements were made for participants to be interviewed after their consultations. Participants were informed of their voluntary participation and that they could decline to participate or withdraw from the study at any time, without any negative consequences. Confidentiality and anonymity of participants were maintained throughout the study by non-disclosure of information obtained and analysis of data as \u2018group\u2019 data. Participants who had psychological distress during the interviews were referred to the hospital social worker for counselling and follow-up care, as pre-arranged by the researchers.Ethical clearance for the study was granted by the Medunsa Research Ethics Committee of the University of Limpopo (MCREC/PH/114/2007), South Africa. The study was conducted following the standard ethical guidelines on conducting gender-based violence studies as stipulated by the WHO,12 The health setting has been identified as one of the best contexts in which IPV can be identified and studied, mainly because of its accessibility and because women who have experienced this form of violence or abuse make greater use of health services than those who have not suffered such an experience.14This study was conducted to determine the prevalence of IPV and explore the risk factors associated with this type of violence against women who visited a public hospital in Botswana. A descriptive, cross-sectional survey was conducted among adult female participants aged 21 years and older (the lower age limit was chosen because of consent rules in Botswana) who sought medical care for themselves or their children in a public hospital in Botswana. Participants were recruited after their medical history was taken, in order to exclude those with serious physical illnesses . Moreover, participants were interviewed after their consultation, as their medical conditions could then be considered as stable. A hospital setting was used for this study in order to reduce the risk of further abuse of participants, especially if accompanied by their abusive intimate partners.Two trained, female research assistants fluent in Setswana (participants\u2019 home language) and English assisted with data collection. The statistics program SPSS version 14.0 was used to analyse data and a chi-square test and univariate logistic regression analysis were used to determine the relationships between socio-demographic characteristics and behavioural risk factors associated with IPV. Odds ratios were obtained for each risk factor and logistic regression analysis was done to determine the relationship between the risk factors and IPV.From a sample of 352 that was recruited, a total of 320 adult women who attended the outpatient department at a public hospital in Botswana consented to and participated in this study (a 90.9% response rate). Participants were enrolled consecutively over a three-month period on outpatient days that were quieter \u2013 hence some days were omitted. Some participants were recruited and agreed to participate in the study but because the interviews were conducted after their consultations, they did not come back to the researchers as they were in a hurry to return home.Results indicated the participants\u2019 marital statuses at the time of the study as follows: 173 (54%) were single, 75 (23%) were married, 14 (4%) were divorced and equal proportions indicated that 29 (9%) were widowed and cohabiting with their intimate partners .The majority (91.9%) indicated that they had formal education, of which 25% had post-secondary level education. Only 8.1% indicated that they did not have any formal education .According to the results, 140 (44%) participants were unemployed and had no source of income, 117 (37%) were formally employed either by the government or in private establishments, 27 (8%) were self-employed and 11% were engaged in casual jobs. Of those employed, 78 (43%) indicated that they earned below BWP1000 per month . This was categorised into: (1) a lifetime, or (2) within-one-year experience of IPV. As depicted in Participants were asked if they were financially dependent on their male partners. Responses indicated that 208 (65%) denied financial dependence, compared to 112 (35%) who admitted to such dependence, as they otherwise had no source of income, being unemployed.Slightly more than half of the participants  stated that their intimate partners consumed alcohol, of which 54 (16.9%) were habitual alcohol drinkers . About tp-value < 0.005). Chi-square analysis showed a significant association between participants\u2019 marital status and lifetime experience of abuse  and experience of abuse in the previous year .Participants were asked about known risk factors associated with IPV. Participants who reported experiences of IPV in their lifetime  were asked to indicate the person(s) they had reported the experiences of abuse to. Slightly more than half of the participants (51%) had reported their IPV experiences to close relatives and 40 (25.1%) had reported to the police. Eight respondents (5.03%) stated that they had reported IPV experiences to the nearest hospital and an equal number of participants reported it to other people, mainly social workers  and friends . The remaining participants  indicated that they did not report their IPV experiences for various reasons (not explored in this paper).7 A WHO report on violence and health indicates that young women and those below the poverty line are disproportionately affected by IPV. 11 Previous reports on IPV have shown that the young ages of male perpetrators and their victims could also be a risk factor to violence and abuse because of various factors such as immaturity, poverty and unemployment.The results of this study showed that IPV is common in young women and those who are economically dependent on their male partners. These findings concur with those from other national surveys done globally, which show that IPV is more common among women than men.15 In a similar study conducted in Uganda in 2003, the authors estimated the lifetime prevalence of partner abuse among women to be 54%, while the past-year prevalence was 14%.16The results of this study estimate the lifetime and past-year prevalence of IPV to be 49.7% and 21.2%, respectively. This indicates a high prevalence of IPV among the study population, that is, one in every two and one in every five adult female patients who visited the out-patient department of the institution had experienced lifetime and past-year IPV, respectively. These findings are similar to those from a study conducted in China in 2005, which showed the lifetime and past-year prevalence estimations to be 43% and 26%, respectively.17 Findings from a similar study conducted among female patients in a public hospital in Durban  showed an estimated lifetime prevalence of IPV of 38%.18 Data from health care-based IPV prevalence studies in the United Kingdom in 2004 estimated lifetime and past-year prevalence to be 12% \u2013 46% and 6% \u2013 28% respectively,19 while in the United States of America in 2002, it was 30% \u2013 39% and 6% \u2013 23%, respectively.20 Although IPV is regarded as a global concern, the challenge of its underreporting affects the prevalence estimates and magnitude of this form of abuse.19In South Africa, the results of a WHO population-based survey carried out in 1998 estimated the national lifetime prevalence of IPV among women to be 13% and the past-year prevalence of IPV to be 11%. Furthermore, provincial figures established that the Eastern Cape province had the highest lifetime prevalence of 27% and a past-year prevalence of 11%.16A London-based study in 2002 on domestic violence revealed that the lifetime prevalence of partner violence in health care settings was 41% and the past-year prevalence was 17%.20In 1999, a national study on violence against women conducted in Botswana by the Women's Affairs Department found that violence against women was an immense problem, with three out of every five women having been a victim of such violence.9 In a similar study in Uganda, the authors estimated the lifetime prevalence of partner abuse among women to be 54%, while the past-year prevalence was 14%.p-values included the participants\u2019 questioning of male partners about their extra-marital relationship(s) (p < 0.0001), financial dependence on the male partner (p = 0.002), and refusing to engage in a sexual relationship (p < 0.0001). All were found to increasingly expose participants to IPV.Several risk factors have been ascribed to IPV, including socio-demographic, cultural and behavioural factors. In this study, as reported by the participants, infidelity and actions against the wishes of the male partners were the most common risk factors for IPV, with odds ratios of 23.26 (95% CI: 9.31\u201358.09) and 63.81 (95% CI: 7.10\u2013573.42), respectively. Other factors with statistically significant c2 = 40.967; p < 0.001) it was not reported by most of the participants as contributing to their experience of IPV. The most common behavioural risk factors associated with IPV found in studies carried out in China, USA, UK, South Africa, Uganda and Malawi are (1) extramarital affairs, (2) use of alcohol and other drugs, (3) doing things against the wishes of the male partner and (4) arguments about monetary issues .21 Results from other studies revealed that alcohol did not initiate IPV, but worsened its outcomes in terms of severity.22Regarding alcohol and other substances used by male partners, although there was a significant association with IPV  a relatively young age, (2) poverty or unemployment, (3) being divorced or separated and (4) a low level of education.14Several studies have revealed an association between socio-demographic characteristics of both the victims of IPV and the offenders and significant relationships.c2 = 7.991; p = 0.035) for a lifetime experience of abuse, where the chances of abuse decreased with increasing age of participants. Such findings (that IPV occurs more frequently in younger people) was also supported by findings from a study conducted in London in 2002, UK, which confirmed that women younger than 45 years (with the highest risk occurring between the ages of 16 and24 years) have a higher risk of experiencing IPV than those older than 45 years.20 This has been ascribed to immaturity and lack of patience among partners in a relationship.1 Results of this study did not reveal any statistically significant association between age and a past year's experience of abuse , which is similar to results of a similar study carried out in China.15 The reason for this difference is not clear.The results of this study further showed a strong relationship between the ages of participants and the occurrence of abuse. This association was only significant  between marital status and lifetime experience of abuse, with the highest occurrence among divorced participants (93%), followed by cohabiting partners (75%), singles (49%) and married partners(40%) and the lowest occurrence among widowed participants (34%). This trend was also found with a past-year experience of abuse. A similar trend and order of occurrence, was found in the National Violence Against Women Survey carried out in the USA in 2000.2 Several other studies conducted in Botswana, South Africa, USA, China and Malawi also reported similar associations, with the highest occurrence among unmarried and cohabiting couples.22This study found a strong association  between the educational level of participants and the occurrence of abuse: both educated and uneducated women experienced abuse equally. This was supported by the findings of a Ugandan study, which established that the educational level of women only reduced the frequency of IPV but did not prevent it.16Studies conducted in 2005 in South Africa and Malawi have found that a lower educational status exposes women to IPV.7 This study found that about 44% of all participants were unemployed and therefore did not earn any income, 35% depended economically on their male partners, while others depended on parents and relatives. A significant relationship  was found between the \u2018economic status\u2019 of abused participants and the experience of abuse and the risk decreased as the amount of income that was earned increased. This is in agreement with studies carried out in Africa, Asia and America, which found that women with low socio-economic status are more prone to abuse.22Unemployment, poverty and economic dependence of women expose them to IPV.21 A similar trend was found by researchers in a South Africa national survey on partner violence.18 A high level of education, however, does not rule out violence: it sometimes predisposes women to abuse, especially if the male partner is less educated.14A systematic review of relevant studies conducted in the USA, UK and Malawi found that the low educational levels of women predispose them to abuse by their intimate partners.22 The results of this study also indicated a very strong association between the frequency of use of alcohol and other drugs (both with p < 0.001) by the male partner and the occurrence of IPV in their relationships. There are significant differences between studies in terms of the methods used to measure the presence or absence of alcohol and in the definition of alcohol consumption as a risk factor for the development of violent behaviour. A Chinese study revealed that the use of cigarettes and other drugs increased the chances of a man to abuse his female partner.15 This is consistent with the significant association between the use of other drugs (mainly cigarettes) and occurrence of abuse found in this study.The consumption of alcohol, a major cause of many social vices, has been found to be related to IPV. A number of studies reveal that alcohol only contributes to violence rather than causing it, and that those women who live with heavy drinkers are at far greater risk of physical partner violence, which tends to be more serious, than that found in those not consuming alcohol.21 The results of this study are not consistent with these findings, since no statistically significant association was found between participants\u2019 experiences of abuse and economic dependence or independence on their male partners . The majority of the women who participated in this study stated that they were not economically dependent on their male partners but, despite such confirmation of financial independence, about half of them still experienced abuse and the overall prevalence of abuse was high. Findings from a study conducted in Botswana reported that almost half of the households in Botswana are headed by women who sustain their families, including their male partners or husbands.9 Our results indicated that the majority of the participants were unemployed and earned no income. It did not include consideration of others upon whom the women could depend for financial support.As indicated earlier, studies conducted in the USA, China, Malawi and South Africa found that economic independence of women protected them from various forms of abuse by their male partners.13 For this reason, participants who were accompanied by their partners were not included in the study and thus valuable data could have been overlooked.This study was limited to one public health institution and, although a high response rate was achieved, the views of other women from other institutions, or in the community, regarding their experiences of IPV, could not be explored. Furthermore, because this study was self-reported and retrospective, the risk of \u2018recall\u2019 bias from participants cannot be overruled. In this study participants were recruited in a health care setting, which increases the chance of a \u2018selection\u2019 bias, as it is known that women who experienced violence and abuse make greater use of health services, resulting in a possible overestimation of the prevalence of IPV in the general population. On the other hand, because of the methodological limitations imposed by the nature of this study, the researchers had to protect participants from further harm and abuse by their partners, as recommended in the ethical and safety guidelines for research on domestic violence.IPV is a common public health problem globally. The prevalence of alleged IPV in Botswana is relatively high (49.7%), especially among young adult women, but the prevalence of reported IPV is low (13.2%). It is essential that women are regularly screened in public and private health care settings for undisclosed IPV. In order to quantify the magnitude of such violence, and to implement interventions that can lead to improved outcomes for women who have experienced IPV, it is crucial that clinical guidelines be made available to enable health care professionals to conduct effective screening for IPV. It is our view that the risk of benefit versus harm could be determined once the magnitude of IPV has been established through IPV screening.", "texts": ["Intimate partner violence (IPV) is common worldwide and occurs across social, economic, religious and cultural groups. This makes it an important public health issue for health care providers. In South Africa, the problem of violence against women is complex and it has social and public health consequences. The paucity of data on IPV is related to underreporting and a lack of screening of this form of violence in health care settings.The aim of this study was to determine the prevalence of IPV and explore the risk factors associated with this type of violence against women who visited a public hospital in Botswana.A descriptive, cross-sectional survey was conducted among randomly sampled adult women aged 21 years and older, during their hospital visits in 2007. Data were obtained by means of structured interviews, after obtaining written and signed, informed consent from each participant.2 = 17.318; p = 0.001) and IPV, as well as cigarette smoking  and IPV.A total of 320 women participated in this study. Almost half (49.7%) reported having had an experience of IPV in one form or another at some point in their lifetime, while 68 (21.2%) reported a recent incident of abuse by their partners in the past year. Experiences of IPV were predominantly reported by women aged 21 \u2013 30 years . Most of the allegedly abused participants were single  and unemployed . Significant associations were found between alcohol use by participants\u2019 male intimate partners , especially among young adult women, but the prevalence of reported IPV is low (13.2%). It is essential that women are screened regularly in the country's public and private health care settings for IPV. IPV is sometimes referred to as domestic violence. The word \u2018violence\u2019 is also used interchangeably with \u2018abuse\u2019.4 This makes it an important public health issue for health care providers. Most of the time the abuse from IPV is hidden from the public's view and society remains uninformed of the nature and extent of such violence and abuse. Consequently, this form of violence and the extent of the problem cannot be directly observed.In South Africa, the problem of violence against women is complex and has social and public health consequences.5Of concern is the paucity of data on IPV due to \u2018underreporting\u2019 and \u2018lack of screening\u2019, which contributes to the complexity and the magnitude of this form of violence, especially against women. Furthermore, obtaining reliable data on IPV is a complicated and intricate task, because of the private and intimate context in which this form of violence and abuse often takes place and also because of methodological challenges imposed by the nature of such studies.6Research on violence against women is considered an important objective of any programme designed to eradicate this problem. At the fourth World Conference on Women held in Beijing in 1995, one of the strategic objectives established was to study the causes and consequences of violence against women and the efficacy of preventive measures, thus encouraging governments and organisations to promote research in this area.7 The objective of this study was to develop methodologies to measure violence against women and its health repercussions in different cultures.A World Health Organization's (WHO's) population-based survey on women's health and domestic violence against women in 2005 established that 10% \u2013 69% of women had been assaulted by their male intimate partners at some stage in their lives, and that 15% \u2013 30% had been assaulted in the previous year.4 In Africa, men are seen as the head of the marriage or relationship, which indirectly promotes either verbal or physical abuse towards their female partners.8 The latter has also been observed in Mochudi, a village in Botswana, which shares common socio-cultural features with other southern African countries.9Furthermore, the results of the WHO survey showed that the national lifetime prevalence of partner abuse among South African women was estimated at 13% and occurrence in the previous year at 11%. The Eastern Cape was found to have the highest lifetime prevalence of 27% and previous-year prevalence of 11%.10 and the recommendations prescribed in the ethical and safety guidelines for research on domestic violence.11 Written and signed informed consent was obtained from each participant prior to data collection. Special arrangements were made for participants to be interviewed after their consultations. Participants were informed of their voluntary participation and that they could decline to participate or withdraw from the study at any time, without any negative consequences. Confidentiality and anonymity of participants were maintained throughout the study by non-disclosure of information obtained and analysis of data as \u2018group\u2019 data. Participants who had psychological distress during the interviews were referred to the hospital social worker for counselling and follow-up care, as pre-arranged by the researchers.Ethical clearance for the study was granted by the Medunsa Research Ethics Committee of the University of Limpopo (MCREC/PH/114/2007), South Africa. The study was conducted following the standard ethical guidelines on conducting gender-based violence studies as stipulated by the WHO,12 The health setting has been identified as one of the best contexts in which IPV can be identified and studied, mainly because of its accessibility and because women who have experienced this form of violence or abuse make greater use of health services than those who have not suffered such an experience.14This study was conducted to determine the prevalence of IPV and explore the risk factors associated with this type of violence against women who visited a public hospital in Botswana. A descriptive, cross-sectional survey was conducted among adult female participants aged 21 years and older (the lower age limit was chosen because of consent rules in Botswana) who sought medical care for themselves or their children in a public hospital in Botswana. Participants were recruited after their medical history was taken, in order to exclude those with serious physical illnesses . Moreover, participants were interviewed after their consultation, as their medical conditions could then be considered as stable. A hospital setting was used for this study in order to reduce the risk of further abuse of participants, especially if accompanied by their abusive intimate partners.Two trained, female research assistants fluent in Setswana (participants\u2019 home language) and English assisted with data collection. The statistics program SPSS version 14.0 was used to analyse data and a chi-square test and univariate logistic regression analysis were used to determine the relationships between socio-demographic characteristics and behavioural risk factors associated with IPV. Odds ratios were obtained for each risk factor and logistic regression analysis was done to determine the relationship between the risk factors and IPV.From a sample of 352 that was recruited, a total of 320 adult women who attended the outpatient department at a public hospital in Botswana consented to and participated in this study (a 90.9% response rate). Participants were enrolled consecutively over a three-month period on outpatient days that were quieter \u2013 hence some days were omitted. Some participants were recruited and agreed to participate in the study but because the interviews were conducted after their consultations, they did not come back to the researchers as they were in a hurry to return home.Results indicated the participants\u2019 marital statuses at the time of the study as follows: 173 (54%) were single, 75 (23%) were married, 14 (4%) were divorced and equal proportions indicated that 29 (9%) were widowed and cohabiting with their intimate partners .The majority (91.9%) indicated that they had formal education, of which 25% had post-secondary level education. Only 8.1% indicated that they did not have any formal education .According to the results, 140 (44%) participants were unemployed and had no source of income, 117 (37%) were formally employed either by the government or in private establishments, 27 (8%) were self-employed and 11% were engaged in casual jobs. Of those employed, 78 (43%) indicated that they earned below BWP1000 per month . This was categorised into: (1) a lifetime, or (2) within-one-year experience of IPV. As depicted in Participants were asked if they were financially dependent on their male partners. Responses indicated that 208 (65%) denied financial dependence, compared to 112 (35%) who admitted to such dependence, as they otherwise had no source of income, being unemployed.Slightly more than half of the participants  stated that their intimate partners consumed alcohol, of which 54 (16.9%) were habitual alcohol drinkers . About tp-value < 0.005). Chi-square analysis showed a significant association between participants\u2019 marital status and lifetime experience of abuse  and experience of abuse in the previous year .Participants were asked about known risk factors associated with IPV. Participants who reported experiences of IPV in their lifetime  were asked to indicate the person(s) they had reported the experiences of abuse to. Slightly more than half of the participants (51%) had reported their IPV experiences to close relatives and 40 (25.1%) had reported to the police. Eight respondents (5.03%) stated that they had reported IPV experiences to the nearest hospital and an equal number of participants reported it to other people, mainly social workers  and friends . The remaining participants  indicated that they did not report their IPV experiences for various reasons (not explored in this paper).7 A WHO report on violence and health indicates that young women and those below the poverty line are disproportionately affected by IPV. 11 Previous reports on IPV have shown that the young ages of male perpetrators and their victims could also be a risk factor to violence and abuse because of various factors such as immaturity, poverty and unemployment.The results of this study showed that IPV is common in young women and those who are economically dependent on their male partners. These findings concur with those from other national surveys done globally, which show that IPV is more common among women than men.15 In a similar study conducted in Uganda in 2003, the authors estimated the lifetime prevalence of partner abuse among women to be 54%, while the past-year prevalence was 14%.16The results of this study estimate the lifetime and past-year prevalence of IPV to be 49.7% and 21.2%, respectively. This indicates a high prevalence of IPV among the study population, that is, one in every two and one in every five adult female patients who visited the out-patient department of the institution had experienced lifetime and past-year IPV, respectively. These findings are similar to those from a study conducted in China in 2005, which showed the lifetime and past-year prevalence estimations to be 43% and 26%, respectively.17 Findings from a similar study conducted among female patients in a public hospital in Durban  showed an estimated lifetime prevalence of IPV of 38%.18 Data from health care-based IPV prevalence studies in the United Kingdom in 2004 estimated lifetime and past-year prevalence to be 12% \u2013 46% and 6% \u2013 28% respectively,19 while in the United States of America in 2002, it was 30% \u2013 39% and 6% \u2013 23%, respectively.20 Although IPV is regarded as a global concern, the challenge of its underreporting affects the prevalence estimates and magnitude of this form of abuse.19In South Africa, the results of a WHO population-based survey carried out in 1998 estimated the national lifetime prevalence of IPV among women to be 13% and the past-year prevalence of IPV to be 11%. Furthermore, provincial figures established that the Eastern Cape province had the highest lifetime prevalence of 27% and a past-year prevalence of 11%.16A London-based study in 2002 on domestic violence revealed that the lifetime prevalence of partner violence in health care settings was 41% and the past-year prevalence was 17%.20In 1999, a national study on violence against women conducted in Botswana by the Women's Affairs Department found that violence against women was an immense problem, with three out of every five women having been a victim of such violence.9 In a similar study in Uganda, the authors estimated the lifetime prevalence of partner abuse among women to be 54%, while the past-year prevalence was 14%.p-values included the participants\u2019 questioning of male partners about their extra-marital relationship(s) (p < 0.0001), financial dependence on the male partner (p = 0.002), and refusing to engage in a sexual relationship (p < 0.0001). All were found to increasingly expose participants to IPV.Several risk factors have been ascribed to IPV, including socio-demographic, cultural and behavioural factors. In this study, as reported by the participants, infidelity and actions against the wishes of the male partners were the most common risk factors for IPV, with odds ratios of 23.26 (95% CI: 9.31\u201358.09) and 63.81 (95% CI: 7.10\u2013573.42), respectively. Other factors with statistically significant c2 = 40.967; p < 0.001) it was not reported by most of the participants as contributing to their experience of IPV. The most common behavioural risk factors associated with IPV found in studies carried out in China, USA, UK, South Africa, Uganda and Malawi are (1) extramarital affairs, (2) use of alcohol and other drugs, (3) doing things against the wishes of the male partner and (4) arguments about monetary issues .21 Results from other studies revealed that alcohol did not initiate IPV, but worsened its outcomes in terms of severity.22Regarding alcohol and other substances used by male partners, although there was a significant association with IPV  a relatively young age, (2) poverty or unemployment, (3) being divorced or separated and (4) a low level of education.14Several studies have revealed an association between socio-demographic characteristics of both the victims of IPV and the offenders and significant relationships.c2 = 7.991; p = 0.035) for a lifetime experience of abuse, where the chances of abuse decreased with increasing age of participants. Such findings (that IPV occurs more frequently in younger people) was also supported by findings from a study conducted in London in 2002, UK, which confirmed that women younger than 45 years (with the highest risk occurring between the ages of 16 and24 years) have a higher risk of experiencing IPV than those older than 45 years.20 This has been ascribed to immaturity and lack of patience among partners in a relationship.1 Results of this study did not reveal any statistically significant association between age and a past year's experience of abuse , which is similar to results of a similar study carried out in China.15 The reason for this difference is not clear.The results of this study further showed a strong relationship between the ages of participants and the occurrence of abuse. This association was only significant  between marital status and lifetime experience of abuse, with the highest occurrence among divorced participants (93%), followed by cohabiting partners (75%), singles (49%) and married partners(40%) and the lowest occurrence among widowed participants (34%). This trend was also found with a past-year experience of abuse. A similar trend and order of occurrence, was found in the National Violence Against Women Survey carried out in the USA in 2000.2 Several other studies conducted in Botswana, South Africa, USA, China and Malawi also reported similar associations, with the highest occurrence among unmarried and cohabiting couples.22This study found a strong association  between the educational level of participants and the occurrence of abuse: both educated and uneducated women experienced abuse equally. This was supported by the findings of a Ugandan study, which established that the educational level of women only reduced the frequency of IPV but did not prevent it.16Studies conducted in 2005 in South Africa and Malawi have found that a lower educational status exposes women to IPV.7 This study found that about 44% of all participants were unemployed and therefore did not earn any income, 35% depended economically on their male partners, while others depended on parents and relatives. A significant relationship  was found between the \u2018economic status\u2019 of abused participants and the experience of abuse and the risk decreased as the amount of income that was earned increased. This is in agreement with studies carried out in Africa, Asia and America, which found that women with low socio-economic status are more prone to abuse.22Unemployment, poverty and economic dependence of women expose them to IPV.21 A similar trend was found by researchers in a South Africa national survey on partner violence.18 A high level of education, however, does not rule out violence: it sometimes predisposes women to abuse, especially if the male partner is less educated.14A systematic review of relevant studies conducted in the USA, UK and Malawi found that the low educational levels of women predispose them to abuse by their intimate partners.22 The results of this study also indicated a very strong association between the frequency of use of alcohol and other drugs (both with p < 0.001) by the male partner and the occurrence of IPV in their relationships. There are significant differences between studies in terms of the methods used to measure the presence or absence of alcohol and in the definition of alcohol consumption as a risk factor for the development of violent behaviour. A Chinese study revealed that the use of cigarettes and other drugs increased the chances of a man to abuse his female partner.15 This is consistent with the significant association between the use of other drugs (mainly cigarettes) and occurrence of abuse found in this study.The consumption of alcohol, a major cause of many social vices, has been found to be related to IPV. A number of studies reveal that alcohol only contributes to violence rather than causing it, and that those women who live with heavy drinkers are at far greater risk of physical partner violence, which tends to be more serious, than that found in those not consuming alcohol.21 The results of this study are not consistent with these findings, since no statistically significant association was found between participants\u2019 experiences of abuse and economic dependence or independence on their male partners . The majority of the women who participated in this study stated that they were not economically dependent on their male partners but, despite such confirmation of financial independence, about half of them still experienced abuse and the overall prevalence of abuse was high. Findings from a study conducted in Botswana reported that almost half of the households in Botswana are headed by women who sustain their families, including their male partners or husbands.9 Our results indicated that the majority of the participants were unemployed and earned no income. It did not include consideration of others upon whom the women could depend for financial support.As indicated earlier, studies conducted in the USA, China, Malawi and South Africa found that economic independence of women protected them from various forms of abuse by their male partners.13 For this reason, participants who were accompanied by their partners were not included in the study and thus valuable data could have been overlooked.This study was limited to one public health institution and, although a high response rate was achieved, the views of other women from other institutions, or in the community, regarding their experiences of IPV, could not be explored. Furthermore, because this study was self-reported and retrospective, the risk of \u2018recall\u2019 bias from participants cannot be overruled. In this study participants were recruited in a health care setting, which increases the chance of a \u2018selection\u2019 bias, as it is known that women who experienced violence and abuse make greater use of health services, resulting in a possible overestimation of the prevalence of IPV in the general population. On the other hand, because of the methodological limitations imposed by the nature of this study, the researchers had to protect participants from further harm and abuse by their partners, as recommended in the ethical and safety guidelines for research on domestic violence.IPV is a common public health problem globally. The prevalence of alleged IPV in Botswana is relatively high (49.7%), especially among young adult women, but the prevalence of reported IPV is low (13.2%). It is essential that women are regularly screened in public and private health care settings for undisclosed IPV. In order to quantify the magnitude of such violence, and to implement interventions that can lead to improved outcomes for women who have experienced IPV, it is crucial that clinical guidelines be made available to enable health care professionals to conduct effective screening for IPV. It is our view that the risk of benefit versus harm could be determined once the magnitude of IPV has been established through IPV screening."]}
{"representative": "The objective of this study was to investigate factors contributing to intimate partner violence in pregnancy among antenatal attendees at the health facilities in West Pokot Sub-County. The study was done in West Pokot Sub-County.Using cross sectional study design, a total of 238 antenatal attendees were systematically sampled for the study. Four focused group discussions and 20 key informant interviews were conducted for qualitative data collection. Qualitative data was consolidated into various themes while bivariate and logistic regression analysis was done to determine factors associated with experience of IPV in the index of pregnancy with P \u2264 0.05 being considered significant.The study found prevalence of overall, physical, psychological and sexual IPV in pregnancy to be 66.9%, 29.9%, 55.8% and 39.2% respectively. After adjusting for confounders, Overall IPV in pregnancy was significantly associated with Alcohol intake by partner  and partner's level of education , while psychological and sexual IPV was significantly associated with age of partner  and age of pregnant women  respectively. The care offered to antenatal attendees experiencing IPV was not in line with WHO guidelines and standard on handling gender based violence cases.The study finding indicates that IPV in pregnancy among antenatal attendees in West Pokot is very high. This unearths the gaps on gender based violence interventions in the maternal and child health programs. Violence against women perpetuated by intimate partners is a worldwide and an important public health concern as well as human rights issue. More than 1.3 million people worldwide die each year as a result of violence in all its forms, accounting for 2.5% of global mortality . In KenyStudy area: The study was conducted in health facilities in West Pokot Sub-County in West Pokot County, Kenya. It lies within longitude 34\u00b047' and 35\u00b035' East and latitude 1 and 2 North.Research design: This was both quantitative and qualitative descriptive cross-sectional study to determine the prevalence of intimate partner violence during the pregnancy among antenatal attendees in 11 sampled health facilities.Sampling procedure: Stratified two stage random sampling was used in this study. The health facilities in the Sub-County were first stratified according to MOH service delivery levels . This resulted into three strata; Level II, III and IV from which 11 health facilities were proportionately and randomly sampled from a total of 20 health facilities in the Sub-County. The respondents were distributed proportionately to each health facility depending on the average number antenatal attendees in health facilities in the year 2012 as per District health information system .This was followed by systematic random sampling of 238 participant at interval of three mothers at each health facility to identify the respondents where the interval was the overage monthly antennal attendance divided by required sample size (622/238 = 2.613\u22483). The starting point was randomly generated number at each facility included in the study. This was done using the established clinic queues to systematically sample antenatal attendees for interview until the sample size was achieved for each health facility. Data was collected within one month from 1st to 26thSeptember 2014 to avoid any bias that might have resulted from antenatal revisits in the following month.Data analysis: Data was entered; cleaned, analyzed and stored using SPSS. Descriptive analysis of variables and graphical presentation was done using proportions and frequency to describe the social demographic characteristics of women and intimate partner's. Prevalence of women reporting the various forms of IPV in the current pregnancy was sought. Odd ratio was used to show the strength of associations. Bivariate analysis was done to compare independent factors of women who experience violence in the index of pregnancy with women who did not. Multiple logistic regression analysis predicting overall, physical, psychological and sexual IPV was used to explore the adjusted association of covariates that had a p < 0.1 in the bivariate analyses with a P \u2264 0.05 being considered significant. Responses from the FGDs and KIIs were analyzed by content analysis, summarized under various themes, inferences made from each theme and conclusions drawn was then triangulated with the data from the questionnaire.Sociodemographic characteristics of respondents: The study approached 238 antenatal attendees and achieved a response rate of 224 (94.1%). Among the 224 women respondents, 44 (19.6% were aged between 35 and 39), 20 (8.9%) were aged between 45-49. More respondents reported to have had more than one pregnancy 117 (52.2%) while 311 (13.6%), 90 (40.2%) and 103(45%) were in their first, second and third trimesters respectively. Most respondents reported to be married 184 (82.1%) with 116 (51.8%) having been in marriage for four year and less and only 65 (29%) had been married for ten years and above. Most of women had formal education 182 (81.3%) with the highest level of complete primary school 114 (50.9%). The majority of the respondents 168 (75%) were unemployed.Prevalence of intimate partner violence: The prevalence of overall, physical, psychological and sexual IPV was in the current pregnancy was 150 (66.9%), 67 (29.9%), 125 (55.8%), 88 (39.2%) respectively. Figure 1 is a three-way contingency table analysis of different forms of IPV experienced singly or combination. These results were also supported by the outcome of the FGDs. Across all the FGDs participants mentioned psychological, physical, sexual, and economical violence. Psychological was ranked first, Economical second; where the man controls the expenditure of the woman, sexual third and physical fourth .Predisposing risk factors of IPV in pregnancy: The bivariate analysis showed association between various factors and overall IPV among the pregnant women, however only alcohol intake by partner was significantly associated with overall IPV (p = 0.000). Risk factors associated with physical violence: Level of education of pregnant women, polygamy marriage and alcohol intake by both partner and pregnant women were significantly associated with physical IPV in bivariate analysis (p \u2264 0.05). Risk factors associated with psychological violence: Age of partner, Length of relationship and Partner's alcohol intake were significantly associated with psychological IPV, (P < 0.05) in the bivariate analysis while Multiple logistic regression analysis indicated two factors to be associated with psychological IPV. Pregnant women with partner less than 25 years of age were two time more likely to experience psychological IPV than women whose partner were more than 25 years of age (p = 0.007) while pregnant women with partner who takes alcohol were slightly more likely to experience psychological IPV than those whose partner don't take alcohol (p = 0.000) (= 0.000) .Risk factors associated with sexual violence: Partner's level of education and partner alcohol intake were significantly associated with sexual IPV (P < 0.05) while age of respondent was not significantly associated with sexual IPV (P = 0.065) in bivariate analysis. However multiple logistic regression analysis indicated only alcohol intake by partner to be significantly associated with sexual IPV, (P = 0.015). Pregnant women with partner's who take alcohol were 2.486 more likely to experience sexual IPV than pregnant women whose partner were not taking alcohol  a higher prevalence than that of many conditions normally screened for during pregnancy.Risk factors of IPV in pregnancy among antenatal attendees;Quality of care offered to pregnant women experiencing intimate partner violence.The authors declare no competing interest.", "texts": ["The objective of this study was to investigate factors contributing to intimate partner violence in pregnancy among antenatal attendees at the health facilities in West Pokot Sub-County. The study was done in West Pokot Sub-County.Using cross sectional study design, a total of 238 antenatal attendees were systematically sampled for the study. Four focused group discussions and 20 key informant interviews were conducted for qualitative data collection. Qualitative data was consolidated into various themes while bivariate and logistic regression analysis was done to determine factors associated with experience of IPV in the index of pregnancy with P \u2264 0.05 being considered significant.The study found prevalence of overall, physical, psychological and sexual IPV in pregnancy to be 66.9%, 29.9%, 55.8% and 39.2% respectively. After adjusting for confounders, Overall IPV in pregnancy was significantly associated with Alcohol intake by partner  and partner's level of education , while psychological and sexual IPV was significantly associated with age of partner  and age of pregnant women  respectively. The care offered to antenatal attendees experiencing IPV was not in line with WHO guidelines and standard on handling gender based violence cases.The study finding indicates that IPV in pregnancy among antenatal attendees in West Pokot is very high. This unearths the gaps on gender based violence interventions in the maternal and child health programs. Violence against women perpetuated by intimate partners is a worldwide and an important public health concern as well as human rights issue. More than 1.3 million people worldwide die each year as a result of violence in all its forms, accounting for 2.5% of global mortality . In KenyStudy area: The study was conducted in health facilities in West Pokot Sub-County in West Pokot County, Kenya. It lies within longitude 34\u00b047' and 35\u00b035' East and latitude 1 and 2 North.Research design: This was both quantitative and qualitative descriptive cross-sectional study to determine the prevalence of intimate partner violence during the pregnancy among antenatal attendees in 11 sampled health facilities.Sampling procedure: Stratified two stage random sampling was used in this study. The health facilities in the Sub-County were first stratified according to MOH service delivery levels . This resulted into three strata; Level II, III and IV from which 11 health facilities were proportionately and randomly sampled from a total of 20 health facilities in the Sub-County. The respondents were distributed proportionately to each health facility depending on the average number antenatal attendees in health facilities in the year 2012 as per District health information system .This was followed by systematic random sampling of 238 participant at interval of three mothers at each health facility to identify the respondents where the interval was the overage monthly antennal attendance divided by required sample size (622/238 = 2.613\u22483). The starting point was randomly generated number at each facility included in the study. This was done using the established clinic queues to systematically sample antenatal attendees for interview until the sample size was achieved for each health facility. Data was collected within one month from 1st to 26thSeptember 2014 to avoid any bias that might have resulted from antenatal revisits in the following month.Data analysis: Data was entered; cleaned, analyzed and stored using SPSS. Descriptive analysis of variables and graphical presentation was done using proportions and frequency to describe the social demographic characteristics of women and intimate partner's. Prevalence of women reporting the various forms of IPV in the current pregnancy was sought. Odd ratio was used to show the strength of associations. Bivariate analysis was done to compare independent factors of women who experience violence in the index of pregnancy with women who did not. Multiple logistic regression analysis predicting overall, physical, psychological and sexual IPV was used to explore the adjusted association of covariates that had a p < 0.1 in the bivariate analyses with a P \u2264 0.05 being considered significant. Responses from the FGDs and KIIs were analyzed by content analysis, summarized under various themes, inferences made from each theme and conclusions drawn was then triangulated with the data from the questionnaire.Sociodemographic characteristics of respondents: The study approached 238 antenatal attendees and achieved a response rate of 224 (94.1%). Among the 224 women respondents, 44 (19.6% were aged between 35 and 39), 20 (8.9%) were aged between 45-49. More respondents reported to have had more than one pregnancy 117 (52.2%) while 311 (13.6%), 90 (40.2%) and 103(45%) were in their first, second and third trimesters respectively. Most respondents reported to be married 184 (82.1%) with 116 (51.8%) having been in marriage for four year and less and only 65 (29%) had been married for ten years and above. Most of women had formal education 182 (81.3%) with the highest level of complete primary school 114 (50.9%). The majority of the respondents 168 (75%) were unemployed.Prevalence of intimate partner violence: The prevalence of overall, physical, psychological and sexual IPV was in the current pregnancy was 150 (66.9%), 67 (29.9%), 125 (55.8%), 88 (39.2%) respectively. Figure 1 is a three-way contingency table analysis of different forms of IPV experienced singly or combination. These results were also supported by the outcome of the FGDs. Across all the FGDs participants mentioned psychological, physical, sexual, and economical violence. Psychological was ranked first, Economical second; where the man controls the expenditure of the woman, sexual third and physical fourth .Predisposing risk factors of IPV in pregnancy: The bivariate analysis showed association between various factors and overall IPV among the pregnant women, however only alcohol intake by partner was significantly associated with overall IPV (p = 0.000). Risk factors associated with physical violence: Level of education of pregnant women, polygamy marriage and alcohol intake by both partner and pregnant women were significantly associated with physical IPV in bivariate analysis (p \u2264 0.05). Risk factors associated with psychological violence: Age of partner, Length of relationship and Partner's alcohol intake were significantly associated with psychological IPV, (P < 0.05) in the bivariate analysis while Multiple logistic regression analysis indicated two factors to be associated with psychological IPV. Pregnant women with partner less than 25 years of age were two time more likely to experience psychological IPV than women whose partner were more than 25 years of age (p = 0.007) while pregnant women with partner who takes alcohol were slightly more likely to experience psychological IPV than those whose partner don't take alcohol (p = 0.000) (= 0.000) .Risk factors associated with sexual violence: Partner's level of education and partner alcohol intake were significantly associated with sexual IPV (P < 0.05) while age of respondent was not significantly associated with sexual IPV (P = 0.065) in bivariate analysis. However multiple logistic regression analysis indicated only alcohol intake by partner to be significantly associated with sexual IPV, (P = 0.015). Pregnant women with partner's who take alcohol were 2.486 more likely to experience sexual IPV than pregnant women whose partner were not taking alcohol  a higher prevalence than that of many conditions normally screened for during pregnancy.Risk factors of IPV in pregnancy among antenatal attendees;Quality of care offered to pregnant women experiencing intimate partner violence.The authors declare no competing interest."]}
{"representative": "Intimate partner violence (IPV) during pregnancy is prevalent across the world, but more so in low- and middle-income countries. It is associated with various adverse outcomes for mothers and infants. This study sought to determine the prevalence and predictors of IPV among pregnant women attending one midwife and obstetrics unit (MOU) in the Western Cape, South Africa.A convenience sample of 150 pregnant women was recruited to participate in the study. Data were collected using several self-report measures concerning the history of childhood trauma, exposure to community violence, depression and alcohol use. Multivariable logistic models were developed, the first model was based on whether any IPV occurred, the remaining models investigated for physical-, sexual- and emotional abuse.Lifetime and 12-month prevalence rates for any IPV were 44%. The 12-month IPV rates were 32% for emotional and controlling behaviours, 29% physical and 20% sexual abuse. The adjusted model predicting physical IPV found women who were at risk for depression were more likely to experience physical IPV , and the model predicting sexual IPV found that women who reported experiencing community violence were more likely to report 12-month sexual IPV .This is the first study, which illustrates high prevalence rates of IPV among pregnant woman at Mitchells Plain MOU. A significant association was found between 12-month IPV and unintended pregnancy. Further prospective studies in different centres are needed to address generalisability and the effect of IPV on maternal and child outcomes. Violence can have detrimental effects for those who encounter it, often resulting in bodily harm; mental, physical and emotional suffering; loss of productivity; and fatality, representing an increased burden for social and public health sectors  focuses on violence against women in the general population . Alcohol use has been associated with countless personal harms including violence and aggression; elevated rates of IPV; general familial friction as well as poor parenting styles, as it affects both cognitive and physical functioning, often reducing the ability of self-control and increasing the likeliness of violent altercations  in the Western Cape, South Africa, and the associations between alcohol use, depression, childhood abuse and exposure to community violence. This study was conducted at Mitchell's Plain MOU, a primary level maternity facility offering pregnant women antenatal care throughout the pregnancy, as well as HIV testing and counselling. The facility also has a labour ward for deliveries as well as post-natal care. Understanding the frequency of IPV within this community is essential to identify possible need for psychosocial interventions. The present study attempts to address this gap by answering the following two-pronged research question: What is the prevalence of IPV among women attending one antenatal clinic in the Western Cape, South Africa and what are the risk factors associated with IPV among this population.Data were collected at an MOU in the Western Cape, South Africa. This community forms part of one of the largest townships in the Western Cape, South Africa. Townships are commonly used to describe urban or peri-urban communities that are largely economically and geographically underdeveloped.A convenience sample of 150 pregnant women attending antenatal care appointments at the MOU was asked to participate in this study. Participants had to be 18 years or older, pregnant (any term during pregnancy), a registered patient at the MOU, as well as being willing and able to participate in an interview in either English or Afrikaans.Recruitment of participants occurred over a 2-month period (November\u2013December 2015). Potential participants were approached while they waited for the clinic. Appointments for interviews were scheduled for those who interest in participation on days and times that were most convenient for the participants. Sampling took place 5 days of the week for ~5\u00a0h/day.et al., G*Power version 3.1.9 software  for a local grocery store as compensation for their time. Participants who required further intervention after the interview, where assessed and given referrals to social workers, counsellors or mental health nurses, as deemed necessary by the researcher (a registered trauma counsellor).Data were collected using the following measures:Information was collected regarding participant's race, age, level of education, current employment status and marital status, whether the pregnancy was planned or unplanned, the number of previous pregnancies and pregnancy gestation.lifetime and 12 months). It includes subscales for the assessment of emotional abuse and controlling behaviour as well as physical and sexual abuse. Questions such as \u2018Have you ever been hit, slapped, kicked or otherwise physically hurt by your current or previous intimate partner?\u2019 are included. While it has not yet been validated for the use in South Africa, local studies have shown good reliability rates  (23.0) was used to analyse the data. Frequency distributions and descriptive statistics were calculated for categorical and continuous variables. The unadjusted associations between IPV as the dependent variable, and participant demographic characteristics, history of childhood abuse, self-report alcohol abuse and perception of community violence as independent variables, were analysed. In addition, multivariate logistic models were developed to control for demographics and socio-economic variables , alcohol abuse, community violence and childhood trauma. The first was based on whether any IPV occurred (lifetime and 12 months), while the remaining three models investigated IPV for physical abuse, sexual abuse and emotional abuse for both lifetime and 12 months experience. The results of the regression models are reported as odds ratios (ORs) with 95% confidence intervals (CIs).n\u00a0=\u00a093, 62%) and between the ages of 18 and 30 years old . Just over half of the respondents completed high school . Respondents reported that many of them indicated that their current pregnancy was unplanned . Notably of the 115 participants who indicated that their pregnancies were unplanned only 32 (65.3%) specified being in an intimate relationship. More than half of the participants,  reported that they were in their second trimester of pregnancy (weeks 13\u201328). Respondents reported high levels of childhood trauma  and witnessing community violence . It was found that 38.7 and 25.3% met criteria for depression and alcohol, respectively.The socio-demographic details of participants are detailed in n\u00a0=\u00a070, 46.7%), followed by emotional abuse and controlling behaviours  and sexual violence (n\u00a0=\u00a024.7%). Most types of IPV victimisation were reported to occur during the second trimester of pregnancy  (see p\u00a0>\u00a00.05).Both the 12-month and lifetime prevalence rates for IPV were calculated to be 44.7%. Physical violence was the most common form of abuse experienced in the women's lifetime (.2%) see . It was The unadjusted and adjusted associations between participant characteristics and the experience of emotional and controlling behaviours in the past 12 months are reported in The unadjusted and adjusted effects of participant characteristics on the experience of any 12-month IPV are displayed in The unadjusted and adjusted associations between participant characteristics and the experience of sexual IPV in the past 12 months (by an intimate partner) are reported in n\u00a0=\u00a094, 62%), while possible cases of depression and alcohol dependence problems were detected in 38 and 25%, respectively.Several important findings were made. First, the prevalence of IPV among pregnant woman attending an MOU in the Western Cape, South Africa was high. Second, the study identified four main variables as risk factors for IPV in this sample of pregnant women. Significant associations were found to exist between IPV and depressive symptoms; IPV and unintended pregnancies; as well as IPV and exposure to community violence. Furthermore, 82% of all respondents reported experiencing high levels of childhood trauma; 62% had witnessed community violence  were more likely to experience IPV than women who were older than 30. Burgos-Soto et al.  have arget al., et al., et al., et al., et al., et al. (Experiencing depressive symptoms during pregnancy was also found to predict elevated IPV in this sample. The results showed that women with symptoms of depression were four times more likely to experience physical IPV than those who were asymptomatic. Increased symptoms of depression were also found to be significantly associated with any form of IPV in the previous 12 months. Depression may also be an outcome/consequence of IPV rather than a predictor; however as this study was cross-sectional, no directional relationship could be determined. These findings are consistent with studies that have found mental health problems to be highly correlated with experiences of IPV (Rao , et al.  found thet al., et al., et al. (The association between IPV and depression appears to highlight the impact that violence has on the mental health functioning of the individuals exposed to it. However, while no directional link between depressive symptoms and IPV can be inferred from this data, some research has shown that individuals with mental health problems, such as major depressive disorder, are at risk for becoming victims of abuse or ill-treatment (Elbogen & Johnson, , et al.  posit thet al., et al., et al., et al., et al.,Unintended pregnancy was found to be another predictor of IPV in this sample. Women who reported experiencing emotional and controlling behaviours in the previous 12 months were three times more likely to have an unintended pregnancy than women who reported experiencing no abuse. Remarkably, more than 70% of the study's respondents indicated that their current pregnancy was unintended. Furthermore, of those who reported any form of IPV in the past 12 months, 88% of the women in this sample indicated that their current pregnancy was unintended. Studies investigating the association between IPV and unintended pregnancy are limited. However, it does appear to be a relatively widely recognised risk factor (Pallitto et al., th on the list of the 50 most violent communities in the world (Leggit, The fourth predictor of IPV identified in this study was exposure to community violence. Data from this study showed that women who reported witnessing community violence were four times more likely to report 12-month sexual IPV, than women who reported no exposure to community violence. Very little research has been conducted to investigate the relationship between IPV and exposure to community violence. However, recent data have shown that the Western Cape has significantly high levels of violence within its communities (Prinsloo  Leggit, . It is pet al., et al., et al., et al., Where South African policy is concerned, there has been very little recognition of IPV as a major health concern, nor has the development of strategies to effectively deal with IPV been attended to. Currently, the National Mental Health Policy Framework for South Africa (Freeman et al., et al., The study had several limitations. First, the study's sample size is small and drawn from one site, making any generalisation to even this setting as well as other parts of South Africa or elsewhere impossible. The substantial prevalence rate found is supported by other studies in the Cape Town area (Abrahams Recommendations for future research might include longitudinal designs investigating the experience of IPV postnatally and whether there are differences before and after the birth. Longitudinal studies might also provide important data about the long-term impact that IPV has on the mother and child. This would help to inform the development of appropriate intervention strategies and programmes for those affected. The effectiveness of screening and intervention programmes should be investigated. Further research could help examine and identify ways to incorporate screening interventions for IPV among pregnant woman, in primary health care settings. This data this could aid in detecting IPV and linking woman to resources such as non-profit organisations, social services and support groups or legal services.This is the first study of IPV to be conducted with pregnant women receiving antenatal care at the Mitchells Plain MOU. These findings are consistent with findings from other SA studies. The results from this study identified three major risk factors associated with IPV during pregnancy; high levels of unintended pregnancies, witnessing community violence and experiencing depressive symptoms. They also highlight the urgency for the development of appropriate policy and strategies to address IPV, particularly among pregnant women. Due to the high levels of IPV among pregnant woman, healthcare institutions and practitioners need to find new ways to identify, contain and provide adequate intervention and support for the victims.", "texts": ["Intimate partner violence (IPV) during pregnancy is prevalent across the world, but more so in low- and middle-income countries. It is associated with various adverse outcomes for mothers and infants. This study sought to determine the prevalence and predictors of IPV among pregnant women attending one midwife and obstetrics unit (MOU) in the Western Cape, South Africa.A convenience sample of 150 pregnant women was recruited to participate in the study. Data were collected using several self-report measures concerning the history of childhood trauma, exposure to community violence, depression and alcohol use. Multivariable logistic models were developed, the first model was based on whether any IPV occurred, the remaining models investigated for physical-, sexual- and emotional abuse.Lifetime and 12-month prevalence rates for any IPV were 44%. The 12-month IPV rates were 32% for emotional and controlling behaviours, 29% physical and 20% sexual abuse. The adjusted model predicting physical IPV found women who were at risk for depression were more likely to experience physical IPV , and the model predicting sexual IPV found that women who reported experiencing community violence were more likely to report 12-month sexual IPV .This is the first study, which illustrates high prevalence rates of IPV among pregnant woman at Mitchells Plain MOU. A significant association was found between 12-month IPV and unintended pregnancy. Further prospective studies in different centres are needed to address generalisability and the effect of IPV on maternal and child outcomes. Violence can have detrimental effects for those who encounter it, often resulting in bodily harm; mental, physical and emotional suffering; loss of productivity; and fatality, representing an increased burden for social and public health sectors  focuses on violence against women in the general population . Alcohol use has been associated with countless personal harms including violence and aggression; elevated rates of IPV; general familial friction as well as poor parenting styles, as it affects both cognitive and physical functioning, often reducing the ability of self-control and increasing the likeliness of violent altercations  in the Western Cape, South Africa, and the associations between alcohol use, depression, childhood abuse and exposure to community violence. This study was conducted at Mitchell's Plain MOU, a primary level maternity facility offering pregnant women antenatal care throughout the pregnancy, as well as HIV testing and counselling. The facility also has a labour ward for deliveries as well as post-natal care. Understanding the frequency of IPV within this community is essential to identify possible need for psychosocial interventions. The present study attempts to address this gap by answering the following two-pronged research question: What is the prevalence of IPV among women attending one antenatal clinic in the Western Cape, South Africa and what are the risk factors associated with IPV among this population.Data were collected at an MOU in the Western Cape, South Africa. This community forms part of one of the largest townships in the Western Cape, South Africa. Townships are commonly used to describe urban or peri-urban communities that are largely economically and geographically underdeveloped.A convenience sample of 150 pregnant women attending antenatal care appointments at the MOU was asked to participate in this study. Participants had to be 18 years or older, pregnant (any term during pregnancy), a registered patient at the MOU, as well as being willing and able to participate in an interview in either English or Afrikaans.Recruitment of participants occurred over a 2-month period (November\u2013December 2015). Potential participants were approached while they waited for the clinic. Appointments for interviews were scheduled for those who interest in participation on days and times that were most convenient for the participants. Sampling took place 5 days of the week for ~5\u00a0h/day.et al., G*Power version 3.1.9 software  for a local grocery store as compensation for their time. Participants who required further intervention after the interview, where assessed and given referrals to social workers, counsellors or mental health nurses, as deemed necessary by the researcher (a registered trauma counsellor).Data were collected using the following measures:Information was collected regarding participant's race, age, level of education, current employment status and marital status, whether the pregnancy was planned or unplanned, the number of previous pregnancies and pregnancy gestation.lifetime and 12 months). It includes subscales for the assessment of emotional abuse and controlling behaviour as well as physical and sexual abuse. Questions such as \u2018Have you ever been hit, slapped, kicked or otherwise physically hurt by your current or previous intimate partner?\u2019 are included. While it has not yet been validated for the use in South Africa, local studies have shown good reliability rates  (23.0) was used to analyse the data. Frequency distributions and descriptive statistics were calculated for categorical and continuous variables. The unadjusted associations between IPV as the dependent variable, and participant demographic characteristics, history of childhood abuse, self-report alcohol abuse and perception of community violence as independent variables, were analysed. In addition, multivariate logistic models were developed to control for demographics and socio-economic variables , alcohol abuse, community violence and childhood trauma. The first was based on whether any IPV occurred (lifetime and 12 months), while the remaining three models investigated IPV for physical abuse, sexual abuse and emotional abuse for both lifetime and 12 months experience. The results of the regression models are reported as odds ratios (ORs) with 95% confidence intervals (CIs).n\u00a0=\u00a093, 62%) and between the ages of 18 and 30 years old . Just over half of the respondents completed high school . Respondents reported that many of them indicated that their current pregnancy was unplanned . Notably of the 115 participants who indicated that their pregnancies were unplanned only 32 (65.3%) specified being in an intimate relationship. More than half of the participants,  reported that they were in their second trimester of pregnancy (weeks 13\u201328). Respondents reported high levels of childhood trauma  and witnessing community violence . It was found that 38.7 and 25.3% met criteria for depression and alcohol, respectively.The socio-demographic details of participants are detailed in n\u00a0=\u00a070, 46.7%), followed by emotional abuse and controlling behaviours  and sexual violence (n\u00a0=\u00a024.7%). Most types of IPV victimisation were reported to occur during the second trimester of pregnancy  (see p\u00a0>\u00a00.05).Both the 12-month and lifetime prevalence rates for IPV were calculated to be 44.7%. Physical violence was the most common form of abuse experienced in the women's lifetime (.2%) see . It was The unadjusted and adjusted associations between participant characteristics and the experience of emotional and controlling behaviours in the past 12 months are reported in The unadjusted and adjusted effects of participant characteristics on the experience of any 12-month IPV are displayed in The unadjusted and adjusted associations between participant characteristics and the experience of sexual IPV in the past 12 months (by an intimate partner) are reported in n\u00a0=\u00a094, 62%), while possible cases of depression and alcohol dependence problems were detected in 38 and 25%, respectively.Several important findings were made. First, the prevalence of IPV among pregnant woman attending an MOU in the Western Cape, South Africa was high. Second, the study identified four main variables as risk factors for IPV in this sample of pregnant women. Significant associations were found to exist between IPV and depressive symptoms; IPV and unintended pregnancies; as well as IPV and exposure to community violence. Furthermore, 82% of all respondents reported experiencing high levels of childhood trauma; 62% had witnessed community violence  were more likely to experience IPV than women who were older than 30. Burgos-Soto et al.  have arget al., et al., et al., et al., et al., et al. (Experiencing depressive symptoms during pregnancy was also found to predict elevated IPV in this sample. The results showed that women with symptoms of depression were four times more likely to experience physical IPV than those who were asymptomatic. Increased symptoms of depression were also found to be significantly associated with any form of IPV in the previous 12 months. Depression may also be an outcome/consequence of IPV rather than a predictor; however as this study was cross-sectional, no directional relationship could be determined. These findings are consistent with studies that have found mental health problems to be highly correlated with experiences of IPV (Rao , et al.  found thet al., et al., et al. (The association between IPV and depression appears to highlight the impact that violence has on the mental health functioning of the individuals exposed to it. However, while no directional link between depressive symptoms and IPV can be inferred from this data, some research has shown that individuals with mental health problems, such as major depressive disorder, are at risk for becoming victims of abuse or ill-treatment (Elbogen & Johnson, , et al.  posit thet al., et al., et al., et al., et al.,Unintended pregnancy was found to be another predictor of IPV in this sample. Women who reported experiencing emotional and controlling behaviours in the previous 12 months were three times more likely to have an unintended pregnancy than women who reported experiencing no abuse. Remarkably, more than 70% of the study's respondents indicated that their current pregnancy was unintended. Furthermore, of those who reported any form of IPV in the past 12 months, 88% of the women in this sample indicated that their current pregnancy was unintended. Studies investigating the association between IPV and unintended pregnancy are limited. However, it does appear to be a relatively widely recognised risk factor (Pallitto et al., th on the list of the 50 most violent communities in the world (Leggit, The fourth predictor of IPV identified in this study was exposure to community violence. Data from this study showed that women who reported witnessing community violence were four times more likely to report 12-month sexual IPV, than women who reported no exposure to community violence. Very little research has been conducted to investigate the relationship between IPV and exposure to community violence. However, recent data have shown that the Western Cape has significantly high levels of violence within its communities (Prinsloo  Leggit, . It is pet al., et al., et al., et al., Where South African policy is concerned, there has been very little recognition of IPV as a major health concern, nor has the development of strategies to effectively deal with IPV been attended to. Currently, the National Mental Health Policy Framework for South Africa (Freeman et al., et al., The study had several limitations. First, the study's sample size is small and drawn from one site, making any generalisation to even this setting as well as other parts of South Africa or elsewhere impossible. The substantial prevalence rate found is supported by other studies in the Cape Town area (Abrahams Recommendations for future research might include longitudinal designs investigating the experience of IPV postnatally and whether there are differences before and after the birth. Longitudinal studies might also provide important data about the long-term impact that IPV has on the mother and child. This would help to inform the development of appropriate intervention strategies and programmes for those affected. The effectiveness of screening and intervention programmes should be investigated. Further research could help examine and identify ways to incorporate screening interventions for IPV among pregnant woman, in primary health care settings. This data this could aid in detecting IPV and linking woman to resources such as non-profit organisations, social services and support groups or legal services.This is the first study of IPV to be conducted with pregnant women receiving antenatal care at the Mitchells Plain MOU. These findings are consistent with findings from other SA studies. The results from this study identified three major risk factors associated with IPV during pregnancy; high levels of unintended pregnancies, witnessing community violence and experiencing depressive symptoms. They also highlight the urgency for the development of appropriate policy and strategies to address IPV, particularly among pregnant women. Due to the high levels of IPV among pregnant woman, healthcare institutions and practitioners need to find new ways to identify, contain and provide adequate intervention and support for the victims."]}
{"representative": "Evidence-based interventions are essential in the prevention of violence against women (VAW). An understanding of risk factors for male perpetration of VAW using population-based research is crucial for developing such interventions. This study is a baseline assessment of a two-arm unmatched cluster randomised controlled trial (C-RCT), set up to assess the impact of a Rural Response System (RRS) intervention for preventing violence against women and girls in Ghana. This study aims at assessing past year prevalence and risk factors for sexual or physical intimate partner violence (IPV) perpetration among men.The population-based survey involved 2126 men aged 18 and above living in selected communities in 4 districts in the central region of Ghana. Logistic regression techniques were used to determine risk factors for sexual or physical IPV perpetration. All models adjusted for age of respondent and took into account the study design.Half of the men had perpetrated at least one form of violence against their intimate partners in their lifetime while 41% had perpetrated sexual or physical IPV. Majority (93%) of the men had been in relationships in the 12 months preceding the survey, and of these, 23% had perpetrated sexual or physical IPV. Childhood factors associated with sexual or physical IPV included witnessing abuse of mother (aOR:1.40(1.06\u20131.86)), and neglect (aOR:1.81(1.30\u20132.50)). Other major risk factors for IPV perpetration were: having multiple partners (aOR:1.76(1.36\u20132.26)), ), substance use (aOR:1.74(1.25\u20132.43)) and gender inequitable attitudes (aOR:0.94(0.91\u20130.97)).Childhood violence experience and witnessing, risky behaviour  and gender inequitable attitudes are major risk factors for sexual or physical IPV perpetration. Perpetration of sexual or physical IPV tend to co-occur with non-partner violence and emotional IPV perpetration. Interventions targeting these factors are critical in reducing IPV. Intimate partner violence (IPV), which refers to aggressive or coercive behaviours among marital, dating or cohabiting partners, remains a global public health concern due to its adverse health consequences to the victims, which are often women . Strong Prevalence estimates for women\u2019s IPV experience in Ghana is high. The Ghana Demographic Health Survey 2008 (GDHS) showed that two in five women had experienced either emotional, physical or sexual IPV, and one in five women had experienced physical IPV in their lifetime. The same survey found that one in five women had experienced sexual or physical IPV in the 12 months preceding the survey . AnotherStudies amongst men have shown some consistent risk and protective factors for IPV perpetration. Prominent risk factors for IPV perpetration by men include childhood experience of violence  or exposure to violence (e.g. witnessing abuse of mother at the hands of father or boyfriend) and having permissive attitudes towards violence against women (VAW), while having gender equitable attitudes has been found to be protective against IPV perpetration , 13\u201317.Substance abuse and mental health issues have also been found to be key risk factors of IPV perpetration by men. Studies have found cumulative risk of depression and post-traumatic stress disorder symptoms and substance abuse to be associated with intimate partner violence perpetration \u201320. StudMost LMIC, including Ghana, have patriarchal sociocultural values that condone abuse of women\u2019s rights, and have attitudes that make IPV against women acceptable and culturally normal and reinforcing traditional symbolic structures of male dominance and control over women , 24\u201326. In Ghana, despite legislation and advocacy work to reduce the levels of IPV victimisation/perpetration, the effects of such interventions have been inadequate due to limited inclusion of men in such work. Furthermore, most interventions and studies in Ghana have concentrated on women and not included men. The 1998 study by the Gender Studies and Human Rights Documentation Centre (Gender Centre) recommended that the responsibility for men\u2019s perpetration of violence against women and children needs to be shifted to society as a whole rather than put it solely on women . The stuThis paper examines prevalence of sexual or physical IPV perpetration among men and its associated risk or protective factors in central region of Ghana. It is part of a larger intervention study aimed at promoting gender equitable social norms and attitudes in communities, with the overall aim of reducing violence against women. A number of studies have advanced for interventions that promote gender equitable attitudes among men. These studies have also advanced for interventions that promote positive parenting, and that address normalisation of violence against women and children.The data reported in this paper were drawn from a baseline survey of an unmatched cluster randomised controlled trial evaluating the Rural Response System (RRS) intervention to reduce VAW in Central Region of Ghana. The RRS intervention is focused on both men and women, however for the purpose of this paper only baseline data collected from men is presented.The baseline survey was done in four districts located in the Central Region of Ghana. These districts include two which are along the coastline of Ghana and another two inland districts. The Central region has an adult literacy rate of about 50%, with literacy rate among men being higher than that of women (69.8% vs 46.3%). The unemployment rate among men in the region is however slightly lower than that of women (8.0% vs 8.2%) [The baseline survey used clusters listed by the Ghana Statistical Service (GSS) and were used in the Ghana Demographic and Health Survey (DHS). A multistage stratified cluster random sampling process was used to select participants in line with the design for the on-going cluster-Randomised Control trial. Initially, clusters (communities) were randomly selected within each district, after which we randomly selected enumeration areas (EAs) within the selected clusters, and then selected households within the selected EAs using systematic random sampling. We used probability proportional to size (PPS) to select number of EAs within clusters and number of households within EAs. Different EAs were drawn for the men\u2019s survey, separate from those for the women\u2019s survey in each district. A total 10 clusters were selected in each district. An average of 82 households were selected in each of the 10 clusters in each district and an adult male (\u2265 18 years) and who is deemed to live (sleep and eat) in the household, and who has lived in the community for at least a year, was invited to participate in the survey. A total of 2126 men were interviewed.Interviews were conducted in English, Twi or Fante, depending on the participant\u2019s language preference, and data was gathered through face to face interviews and recorded on Personal Digital Assistants. Additional details of the trial design can be found in the study protocol which is registered on Clinical Trials.gov (Identifier: NCTo3237585).The main outcome in this paper is self-reported physical or sexual violence perpetration against an intimate partner in the past 12 months. This dichotomous outcome is derived from 5 physical violence perpetration outcomes and 3 sexual violence perpetration items . These wOther forms of violence measured were emotional IPV (measured using 4 items), single item economic IPV measure and non-partner violence.Some of the protective or risk factors, based on previous literature, measured in the baseline survey included childhood experience or exposure to violence in the home, having gender equitable attitudes and relationship practices, being involved in other forms of violence perpetration (fights with other men or violence against non-partners). Other risk factors measured were sexual behaviours, mental health and substance use as well as partner characteristics.Gender equitable attitudes were measured using the 8-item Gender Equitable Men (GEM) scale adopted from the WHO Multi-Country Study on Women\u2019s Health and Domestic Violence against Women, and look at the extent to which men agree with separate roles for men and women or agree with equality between men and women . Some ofFactor analysis was done to assess the reliability and consistency of the GEM scale in the Ghana context  and GEM score was created as an additive scale with higher scores representing more equitable attitudes.Permissible attitudes towards VAW were measured using two items from the gender attitudes scale. These items were: i) \u201cThere are times when a woman deserves to be beaten\u201d, ii) \u201cA woman should tolerate violence in order to keep her family together\u201d. Participants who agreed (agreed or strongly agreed) to either of the two statements, were considered to have permissible attitudes towards VAW.We also measured individual and community gender norms using 9-item gender relationship scales, adopted from the Stepping Stones/Creating Future study in South Africa . ExampleRelationship Control 8-item scale was used to measure the controlling behaviour of the men towards their intimate partners, done with the purpose of exerting power. Items in this scale include: \u201cI won\u2019t let my partner wear certain things\u201d, \u201cI tell my partner who she can spend time with\u201d and \u201cI want to know where my partner is all of the time\u201d. These items were measured on a 4-point Likert scale. The scale had good internal consistency . An additive score as a measure of the overall controlling behaviour, with high scores indicating more controlling behaviour.Childhood exposure to violence (experienced or witnessed before the age of 18 years) was measured using the Childhood Trauma Scale (CTQ). We used a modified version of the short form of the Childhood Trauma Questionnaire which had a four point Likert scale . HoweverWe used the Centre for Epidemiological Studies Depression Scale (CES_D) to measure level of depression amongst participants . The CESParticipants were asked if they had in the course of their life experienced some traumatic events such as \u2018witnessing murder of friend or relative\u2019, \u2018being victim of armed robbery\u2019 or \u2018witnessed someone being raped\u2019. The trauma exposure was measured using an adapted Life Event Checklist from the PTSD checklist (8 items). We created a dichotomous measure from the binary responses and a participant was considered to have experienced or witnessed a traumatic event if they responded positive to at least 1 of the items.Participants were asked if they use drugs or drink alcohol. On alcohol use, participants indicated how often they take drinks containing alcohol . We then dichotomised the responses based on whether someone ever drinks or not and a combined measure of drug and alcohol use was created.Sexual behaviour risk factor included having multiple sexual partners and being involved in transactional sex. Participants were asked about the number of main and other partners they had had sex with the past year. Involvement in transactional sex was derived from 5 questions that assessed whether a participant had had sex where the partner expected to get monetary or material support. Partner characteristics that were measured include age of partner, employment status, earning disparity and their education level.We analysed various social and demographic factors that in previous research have been found to be associated with IPV perpetration such as education level, marital status, employment status, household food security and age of participant , 14, 37.Ethics approval for the trial was obtained from the South African Medical Research Council Ethics Committee (EC031-9/2015) and the Institutional Review Board at the Noguchi Memorial Institute for Medical Research at the University of Ghana (# 006/15-16). Eligible participants were given information about the purpose of the study, procedures involved, participants\u2019 rights, risks and benefits of participating in the study in the language of their choice and were enrolled in the survey voluntarily. A researcher was present during the initial informed consent process to ensure that participants understood the information, study procedures and their rights. The informed consent process was done in English, Twi or Fante, depending on the participant\u2019s language preference. Written consent was then sought from all eligible participants prior to commencement of the interview. For safety and confidentiality reasons, only one participant was interviewed in each selected household and interviewers ensured that interviews were done in complete privacy. All participants were given unique identification number and their names were not recorded on the questionnaire. This was done to ensure anonymity of the process. Participants were reimbursed with 10 Ghanaian Cedis (~ 3USD) for their time and inconvenience completing the questionnaire.In all analysis procedures, we took into account the multistage sampling design of the survey, with stratification by district and the enumeration areas being the lowest level clusters. We assessed whether there was any relationship between non-response to these respective partner characteristic variables and our outcome variable .Descriptive statistics were presented as mean (with standard deviation) or as frequencies (with percentages). We calculated 95% Confidence Intervals using Taylor linearization. Bivariate relationships between sexual or physical violence perpetration and attitudinal, behavioural and demographic variables were examined using the Pearson\u2019s Chi-Square test for categorical variables and t-tests for continuous variables. We also examined the relationship between childhood experience of violence or exposure to violence and other potential risk factors of IPV perpetration.To investigate potential risk factors associated with physical or sexual IPV perpetration, we first conducted a bivariate analysis using maximum likelihood logit models. All factors associated with IPV perpetration in the bivariate analysis  were put in the multivariate model. We also included any factors which were marginally significant , which we considered as potential meaningful risk factors. The multivariate logistic regression model adjusted for age of participant. To account for clustering, we used generalised linear mixed modelling, with enumeration areas as random effects.We also examined the model for multi-collinearity using VIF, and dropped variables that were highly correlated. For example, we found that individual gender attitudes were highly correlated with perceived community gender attitudes (VIF>10). However, individual gender attitude score had a stronger relationship with IPV perpetration than the perceived community gender attitude score. Thus, in final multivariate logistic model we did not include the perceived community attitude score. We further investigated the effect of including perpetration of non-partner violence and perpetration of emotional violence as risk factors.Of the 2126 participants interviewed, 1973 were married or had a partner/girlfriend in the 12 months preceding the survey. This was the denominator used for our outcome . However, all men interviewed had been in some relationship in their lifetime and were all considered for descriptive analysis on lifetime perpetration of IPV. Due to an error in the skip pattern in the questionnaire, respondents that were not living with their partners/girlfriend did not respond to questions on partner characteristics. In order to utilise information on partner characteristics in the modelling, we created a dummy level in all partner characteristic variables . Apart from partner characteristics, all other variables had very little or no missing data. With very little or no missing information in the explanatory variables, we used listwise deletion in multivariate logistic regression modelling. All analyses were conducted using Stata SE Version 13.Lifetime perpetration was at 27.7% (589/2126), with \u2018slapping\u201d, \u201cpushing or shoving\u201d, also being the most common acts. A total of 328 (16.6%) men had perpetrated some form of sexual violence in past 12 months, with their lifetime prevalence at 27.8%. Overall, a fifth of the men (454/1973) had perpetrated physical or sexual violence against an intimate partner in the 12 months preceding the survey. Almost one- third of the 454 men who had perpetrated sexual or physical IPV, had perpetrated violence against non-partner, and over half (261/454) perpetrated emotional IPV in past year. The prevalence of emotional IPV only was 13%.Experience of any form of childhood abuse was associated with IPV perpetration, with men who had experienced physical neglect being three times more likely to perpetrate IPV , and men who had experienced sexual abuse were two times more likely to perpetrate IPV . Similar risks were observed in those that had experienced physical abuse  or emotional abuse . Witnessing abuse of mother was also strongly associated with IPV perpetration .We also found very significant association between experience of violence or exposure to violence in childhood and having attitudes that endorse VAW. Men who had witnessed abuse of their mother were three times more likely to have attitudes that endorse VAW (OR = 3.3 CI: 2.5\u20134.3). There were significant associations between permissible attitudes towards VAW and childhood neglect or physical abuse (OR = 1.7 and OR = 1.3 respectively). Childhood experience or exposure to violence was also highly associated with substance use. Men who had witnessed abuse of their mother were two times more likely to use alcohol or drugs.Men who perpetrated sexual or physical IPV were more likely to perpetrate sexual violence against a non-partner , and were more likely to perpetrate emotional violence against their intimate partner .Having risky sexual behaviour was also highly associated with IPV perpetration. Men with multiple partners in the past 12 months were three times more likely to have perpetrated sexual or physical IPV . Similarly, men who had been involved in transactional sex or had had sex with sex workers were three times more likely to have perpetrated sexual or physical IPV (OR = 3.23 CI: 2.58\u20134.05).Use of alcohol or drugs was also associated with IPV perpetration, with men who drink or use drugs being twice more likely to perpetrate IPV (OR = 2.41 CI: 1.94\u20133.00). Risk of IPV perpetration increased with increase in depression score . Having experienced some traumatic events was also highly associated IPV perpetration (OR = 2.98 CI: 2.38\u20133.73). However, having post-traumatic stress disorder was partially associated with IPV perpetration . Substance use was highly associated with having multiple partners (OR = 1.7 CI: 1.3\u20132.1), being involved in transactional sex (OR = 2.4 CI: 1.9\u20133.1) and having experienced/witnessed some traumatic events (OR = 1.6 CI: 1.3\u20131.9).Having attitudes that condone VAW was also a strong risk factor for IPV perpetration. Men with permissible attitudes towards VAW were two times more likely to perpetrate IPV . Having gender equitable attitudes reduced a man\u2019s likelihood of perpetrating IPV (OR = 0.91 CI: 0.88\u20130.94). However, there were no significant differences in what the respondents indicated were community gender norms between perpetrators and non-perpetrators. Controlling behaviour was also found to be significantly associated with IPV perpetration, with the odds of IPV perpetration increasing with increase in controlling behaviour (OR = 1.06 CI:1.02\u20131.09).Of the men who provided information about their partner, partner unemployment and partner education were most significant factors associated with IPV perpetration. Men with partners who were more educated than them were more likely to perpetrate IPV compared to men who had the same education levels with their partners (OR = 1.75 CI: 1.24\u20132.47). Most of the men (181/206) with more educated partners had junior secondary school level or lower. A man with an unemployed partner was two times more likely to perpetrate IPV than a man whose partner was employed (OR = 1.70 CI:1.30\u20132.22).In the multivariate logistic regression , childhoOur findings show high levels of sexual or physical IPV perpetration in the selected communities in Ghana with one in five men having perpetrated sexual or physical IPV in the 12 months preceding the survey, and one in ten men having perpetrated physical IPV in 12 months preceding the survey. Sexual IPV prevalence was higher than physical IPV prevalence, and not all perpetrators used all types of violence. However, there was some overlap between sexual and physical IPV, with 6% of the men perpetrating both sexual and physical IPV in the 12 months preceding the survey. Findings from the UN Multi-country study showed variation in the occurrence of sexual or physical IPV with some countries having higher prevalence of sexual IPV than physical IPV and other countries having higher physical IPV prevalence compared to sexual IPV . There aFor lifetime prevalence rates, almost one in every three men had perpetrated some form of physical IPV. Our lifetime prevalence rates are far much higher than findings by Kishor and Bradley, who using data from nationally representative Demographic and Health Surveys in Ghana found a lifetime physical IPV perpetration of 16.3% . HoweverIn this paper, we found that having witnessed abuse of one\u2019s mother increases the risk of IPV perpetration in adulthood. The very significant association between witnessing inter-parental violence and having attitudes that endorse VAW bridges the link between exposure to violence in childhood and IPV perpetration later in life. This is consistent with other studies that have looked at inter-generational transmission of VAW , 41\u201343. In the crude bivariate analysis, both gender attitude measure from the GEM scale and individual attitudes score were strongly associated with IPV perpetration and perceived community gender attitudes was marginally significant. In the multivariate analysis, only individual attitudes were significantly associated with IPV perpetration. However, there was a very strong positive correlation between GEM score and individual gender attitudes score, which might explain the non-significant relationship between GEM score and IPV perpetration in the multivariate model. Our findings are in line with several studies that have found a relationship between gender attitudes and IPV perpetration or experience , 14, 27.Field and colleagues found alcohol consumption was a more influential predictor of IPV perpetration than permissible attitudes towards violence . Apart fBivariate analysis further showed a strong relationship between IPV perpetration and woman\u2019s education level relative to their partner\u2019s education level, with men whose partners were more educated than them having high likelihood of perpetrating IPV. In a study done in India, Ackerson and colleagues found increased likelihood of IPV experience among women with no education but also in women who were more educated than their partner .Findings from the Ghana 2008 DHS showed that women with tertiary education had decreased likelihood of experiencing IPV. HoweverOur study found strong association between risky sexual behaviours  and IPV perpetration, a finding consistent with that of other studies that have looked at risk factors for IPV perpetration/experience and generally interpreted these as indicator variables for a more patriarchal, sexually entitled masculinity , 17, 28.Having an unemployed partner increased men\u2019s likelihood of perpetrating IPV. Several studies have shown that female empowerment through education or income is generally protective against IPV , 13. HigA major limitation of our study is the non-response to partner\u2019s characteristics. Information on partner characteristics would have helped in linking IPV perpetration with women\u2019s characteristics relative to men\u2019s. Another limitation of our study is the unavailability of data at community level that could have helped us understand society-level drivers of IPV perpetration. The findings of this study cannot to be generalised to the whole of Ghana, but provide much needed empirical evidence on which primary VAW prevention interventions can be based, and act as a reference level for the Rural Response System (RRS) intervention to reduce gender-based violence currently ongoing in the districts where the survey was conducted. Based on the cross-sectional study design, we are also mindful that it is not possible to infer causal relationships between IPV perpetration and the risk factors examined in our paper.The study contributes important evidence about factors associated with men\u2019s IPV perpetration in Ghana, and complements findings from studies conducted amongst women. Findings of this study emphasise the urgent need for primary prevention interventions that can address inter-generational transmission of violence and address learned gender inequitable attitudes and norms that condone men\u2019s control and dominance over women. Interrupting the cycle of violence is very critical in reducing men\u2019s perpetration of VAW. Context-specific evidence is critical for designing appropriate and relevant interventions and policies. We also argue that it may be necessary for VAW primary prevention interventions to take into account contextual challenges like poverty and unemployment .S1 File(CSV)Click here for additional data file.", "texts": ["Evidence-based interventions are essential in the prevention of violence against women (VAW). An understanding of risk factors for male perpetration of VAW using population-based research is crucial for developing such interventions. This study is a baseline assessment of a two-arm unmatched cluster randomised controlled trial (C-RCT), set up to assess the impact of a Rural Response System (RRS) intervention for preventing violence against women and girls in Ghana. This study aims at assessing past year prevalence and risk factors for sexual or physical intimate partner violence (IPV) perpetration among men.The population-based survey involved 2126 men aged 18 and above living in selected communities in 4 districts in the central region of Ghana. Logistic regression techniques were used to determine risk factors for sexual or physical IPV perpetration. All models adjusted for age of respondent and took into account the study design.Half of the men had perpetrated at least one form of violence against their intimate partners in their lifetime while 41% had perpetrated sexual or physical IPV. Majority (93%) of the men had been in relationships in the 12 months preceding the survey, and of these, 23% had perpetrated sexual or physical IPV. Childhood factors associated with sexual or physical IPV included witnessing abuse of mother (aOR:1.40(1.06\u20131.86)), and neglect (aOR:1.81(1.30\u20132.50)). Other major risk factors for IPV perpetration were: having multiple partners (aOR:1.76(1.36\u20132.26)), ), substance use (aOR:1.74(1.25\u20132.43)) and gender inequitable attitudes (aOR:0.94(0.91\u20130.97)).Childhood violence experience and witnessing, risky behaviour  and gender inequitable attitudes are major risk factors for sexual or physical IPV perpetration. Perpetration of sexual or physical IPV tend to co-occur with non-partner violence and emotional IPV perpetration. Interventions targeting these factors are critical in reducing IPV. Intimate partner violence (IPV), which refers to aggressive or coercive behaviours among marital, dating or cohabiting partners, remains a global public health concern due to its adverse health consequences to the victims, which are often women . Strong Prevalence estimates for women\u2019s IPV experience in Ghana is high. The Ghana Demographic Health Survey 2008 (GDHS) showed that two in five women had experienced either emotional, physical or sexual IPV, and one in five women had experienced physical IPV in their lifetime. The same survey found that one in five women had experienced sexual or physical IPV in the 12 months preceding the survey . AnotherStudies amongst men have shown some consistent risk and protective factors for IPV perpetration. Prominent risk factors for IPV perpetration by men include childhood experience of violence  or exposure to violence (e.g. witnessing abuse of mother at the hands of father or boyfriend) and having permissive attitudes towards violence against women (VAW), while having gender equitable attitudes has been found to be protective against IPV perpetration , 13\u201317.Substance abuse and mental health issues have also been found to be key risk factors of IPV perpetration by men. Studies have found cumulative risk of depression and post-traumatic stress disorder symptoms and substance abuse to be associated with intimate partner violence perpetration \u201320. StudMost LMIC, including Ghana, have patriarchal sociocultural values that condone abuse of women\u2019s rights, and have attitudes that make IPV against women acceptable and culturally normal and reinforcing traditional symbolic structures of male dominance and control over women , 24\u201326. In Ghana, despite legislation and advocacy work to reduce the levels of IPV victimisation/perpetration, the effects of such interventions have been inadequate due to limited inclusion of men in such work. Furthermore, most interventions and studies in Ghana have concentrated on women and not included men. The 1998 study by the Gender Studies and Human Rights Documentation Centre (Gender Centre) recommended that the responsibility for men\u2019s perpetration of violence against women and children needs to be shifted to society as a whole rather than put it solely on women . The stuThis paper examines prevalence of sexual or physical IPV perpetration among men and its associated risk or protective factors in central region of Ghana. It is part of a larger intervention study aimed at promoting gender equitable social norms and attitudes in communities, with the overall aim of reducing violence against women. A number of studies have advanced for interventions that promote gender equitable attitudes among men. These studies have also advanced for interventions that promote positive parenting, and that address normalisation of violence against women and children.The data reported in this paper were drawn from a baseline survey of an unmatched cluster randomised controlled trial evaluating the Rural Response System (RRS) intervention to reduce VAW in Central Region of Ghana. The RRS intervention is focused on both men and women, however for the purpose of this paper only baseline data collected from men is presented.The baseline survey was done in four districts located in the Central Region of Ghana. These districts include two which are along the coastline of Ghana and another two inland districts. The Central region has an adult literacy rate of about 50%, with literacy rate among men being higher than that of women (69.8% vs 46.3%). The unemployment rate among men in the region is however slightly lower than that of women (8.0% vs 8.2%) [The baseline survey used clusters listed by the Ghana Statistical Service (GSS) and were used in the Ghana Demographic and Health Survey (DHS). A multistage stratified cluster random sampling process was used to select participants in line with the design for the on-going cluster-Randomised Control trial. Initially, clusters (communities) were randomly selected within each district, after which we randomly selected enumeration areas (EAs) within the selected clusters, and then selected households within the selected EAs using systematic random sampling. We used probability proportional to size (PPS) to select number of EAs within clusters and number of households within EAs. Different EAs were drawn for the men\u2019s survey, separate from those for the women\u2019s survey in each district. A total 10 clusters were selected in each district. An average of 82 households were selected in each of the 10 clusters in each district and an adult male (\u2265 18 years) and who is deemed to live (sleep and eat) in the household, and who has lived in the community for at least a year, was invited to participate in the survey. A total of 2126 men were interviewed.Interviews were conducted in English, Twi or Fante, depending on the participant\u2019s language preference, and data was gathered through face to face interviews and recorded on Personal Digital Assistants. Additional details of the trial design can be found in the study protocol which is registered on Clinical Trials.gov (Identifier: NCTo3237585).The main outcome in this paper is self-reported physical or sexual violence perpetration against an intimate partner in the past 12 months. This dichotomous outcome is derived from 5 physical violence perpetration outcomes and 3 sexual violence perpetration items . These wOther forms of violence measured were emotional IPV (measured using 4 items), single item economic IPV measure and non-partner violence.Some of the protective or risk factors, based on previous literature, measured in the baseline survey included childhood experience or exposure to violence in the home, having gender equitable attitudes and relationship practices, being involved in other forms of violence perpetration (fights with other men or violence against non-partners). Other risk factors measured were sexual behaviours, mental health and substance use as well as partner characteristics.Gender equitable attitudes were measured using the 8-item Gender Equitable Men (GEM) scale adopted from the WHO Multi-Country Study on Women\u2019s Health and Domestic Violence against Women, and look at the extent to which men agree with separate roles for men and women or agree with equality between men and women . Some ofFactor analysis was done to assess the reliability and consistency of the GEM scale in the Ghana context  and GEM score was created as an additive scale with higher scores representing more equitable attitudes.Permissible attitudes towards VAW were measured using two items from the gender attitudes scale. These items were: i) \u201cThere are times when a woman deserves to be beaten\u201d, ii) \u201cA woman should tolerate violence in order to keep her family together\u201d. Participants who agreed (agreed or strongly agreed) to either of the two statements, were considered to have permissible attitudes towards VAW.We also measured individual and community gender norms using 9-item gender relationship scales, adopted from the Stepping Stones/Creating Future study in South Africa . ExampleRelationship Control 8-item scale was used to measure the controlling behaviour of the men towards their intimate partners, done with the purpose of exerting power. Items in this scale include: \u201cI won\u2019t let my partner wear certain things\u201d, \u201cI tell my partner who she can spend time with\u201d and \u201cI want to know where my partner is all of the time\u201d. These items were measured on a 4-point Likert scale. The scale had good internal consistency . An additive score as a measure of the overall controlling behaviour, with high scores indicating more controlling behaviour.Childhood exposure to violence (experienced or witnessed before the age of 18 years) was measured using the Childhood Trauma Scale (CTQ). We used a modified version of the short form of the Childhood Trauma Questionnaire which had a four point Likert scale . HoweverWe used the Centre for Epidemiological Studies Depression Scale (CES_D) to measure level of depression amongst participants . The CESParticipants were asked if they had in the course of their life experienced some traumatic events such as \u2018witnessing murder of friend or relative\u2019, \u2018being victim of armed robbery\u2019 or \u2018witnessed someone being raped\u2019. The trauma exposure was measured using an adapted Life Event Checklist from the PTSD checklist (8 items). We created a dichotomous measure from the binary responses and a participant was considered to have experienced or witnessed a traumatic event if they responded positive to at least 1 of the items.Participants were asked if they use drugs or drink alcohol. On alcohol use, participants indicated how often they take drinks containing alcohol . We then dichotomised the responses based on whether someone ever drinks or not and a combined measure of drug and alcohol use was created.Sexual behaviour risk factor included having multiple sexual partners and being involved in transactional sex. Participants were asked about the number of main and other partners they had had sex with the past year. Involvement in transactional sex was derived from 5 questions that assessed whether a participant had had sex where the partner expected to get monetary or material support. Partner characteristics that were measured include age of partner, employment status, earning disparity and their education level.We analysed various social and demographic factors that in previous research have been found to be associated with IPV perpetration such as education level, marital status, employment status, household food security and age of participant , 14, 37.Ethics approval for the trial was obtained from the South African Medical Research Council Ethics Committee (EC031-9/2015) and the Institutional Review Board at the Noguchi Memorial Institute for Medical Research at the University of Ghana (# 006/15-16). Eligible participants were given information about the purpose of the study, procedures involved, participants\u2019 rights, risks and benefits of participating in the study in the language of their choice and were enrolled in the survey voluntarily. A researcher was present during the initial informed consent process to ensure that participants understood the information, study procedures and their rights. The informed consent process was done in English, Twi or Fante, depending on the participant\u2019s language preference. Written consent was then sought from all eligible participants prior to commencement of the interview. For safety and confidentiality reasons, only one participant was interviewed in each selected household and interviewers ensured that interviews were done in complete privacy. All participants were given unique identification number and their names were not recorded on the questionnaire. This was done to ensure anonymity of the process. Participants were reimbursed with 10 Ghanaian Cedis (~ 3USD) for their time and inconvenience completing the questionnaire.In all analysis procedures, we took into account the multistage sampling design of the survey, with stratification by district and the enumeration areas being the lowest level clusters. We assessed whether there was any relationship between non-response to these respective partner characteristic variables and our outcome variable .Descriptive statistics were presented as mean (with standard deviation) or as frequencies (with percentages). We calculated 95% Confidence Intervals using Taylor linearization. Bivariate relationships between sexual or physical violence perpetration and attitudinal, behavioural and demographic variables were examined using the Pearson\u2019s Chi-Square test for categorical variables and t-tests for continuous variables. We also examined the relationship between childhood experience of violence or exposure to violence and other potential risk factors of IPV perpetration.To investigate potential risk factors associated with physical or sexual IPV perpetration, we first conducted a bivariate analysis using maximum likelihood logit models. All factors associated with IPV perpetration in the bivariate analysis  were put in the multivariate model. We also included any factors which were marginally significant , which we considered as potential meaningful risk factors. The multivariate logistic regression model adjusted for age of participant. To account for clustering, we used generalised linear mixed modelling, with enumeration areas as random effects.We also examined the model for multi-collinearity using VIF, and dropped variables that were highly correlated. For example, we found that individual gender attitudes were highly correlated with perceived community gender attitudes (VIF>10). However, individual gender attitude score had a stronger relationship with IPV perpetration than the perceived community gender attitude score. Thus, in final multivariate logistic model we did not include the perceived community attitude score. We further investigated the effect of including perpetration of non-partner violence and perpetration of emotional violence as risk factors.Of the 2126 participants interviewed, 1973 were married or had a partner/girlfriend in the 12 months preceding the survey. This was the denominator used for our outcome . However, all men interviewed had been in some relationship in their lifetime and were all considered for descriptive analysis on lifetime perpetration of IPV. Due to an error in the skip pattern in the questionnaire, respondents that were not living with their partners/girlfriend did not respond to questions on partner characteristics. In order to utilise information on partner characteristics in the modelling, we created a dummy level in all partner characteristic variables . Apart from partner characteristics, all other variables had very little or no missing data. With very little or no missing information in the explanatory variables, we used listwise deletion in multivariate logistic regression modelling. All analyses were conducted using Stata SE Version 13.Lifetime perpetration was at 27.7% (589/2126), with \u2018slapping\u201d, \u201cpushing or shoving\u201d, also being the most common acts. A total of 328 (16.6%) men had perpetrated some form of sexual violence in past 12 months, with their lifetime prevalence at 27.8%. Overall, a fifth of the men (454/1973) had perpetrated physical or sexual violence against an intimate partner in the 12 months preceding the survey. Almost one- third of the 454 men who had perpetrated sexual or physical IPV, had perpetrated violence against non-partner, and over half (261/454) perpetrated emotional IPV in past year. The prevalence of emotional IPV only was 13%.Experience of any form of childhood abuse was associated with IPV perpetration, with men who had experienced physical neglect being three times more likely to perpetrate IPV , and men who had experienced sexual abuse were two times more likely to perpetrate IPV . Similar risks were observed in those that had experienced physical abuse  or emotional abuse . Witnessing abuse of mother was also strongly associated with IPV perpetration .We also found very significant association between experience of violence or exposure to violence in childhood and having attitudes that endorse VAW. Men who had witnessed abuse of their mother were three times more likely to have attitudes that endorse VAW (OR = 3.3 CI: 2.5\u20134.3). There were significant associations between permissible attitudes towards VAW and childhood neglect or physical abuse (OR = 1.7 and OR = 1.3 respectively). Childhood experience or exposure to violence was also highly associated with substance use. Men who had witnessed abuse of their mother were two times more likely to use alcohol or drugs.Men who perpetrated sexual or physical IPV were more likely to perpetrate sexual violence against a non-partner , and were more likely to perpetrate emotional violence against their intimate partner .Having risky sexual behaviour was also highly associated with IPV perpetration. Men with multiple partners in the past 12 months were three times more likely to have perpetrated sexual or physical IPV . Similarly, men who had been involved in transactional sex or had had sex with sex workers were three times more likely to have perpetrated sexual or physical IPV (OR = 3.23 CI: 2.58\u20134.05).Use of alcohol or drugs was also associated with IPV perpetration, with men who drink or use drugs being twice more likely to perpetrate IPV (OR = 2.41 CI: 1.94\u20133.00). Risk of IPV perpetration increased with increase in depression score . Having experienced some traumatic events was also highly associated IPV perpetration (OR = 2.98 CI: 2.38\u20133.73). However, having post-traumatic stress disorder was partially associated with IPV perpetration . Substance use was highly associated with having multiple partners (OR = 1.7 CI: 1.3\u20132.1), being involved in transactional sex (OR = 2.4 CI: 1.9\u20133.1) and having experienced/witnessed some traumatic events (OR = 1.6 CI: 1.3\u20131.9).Having attitudes that condone VAW was also a strong risk factor for IPV perpetration. Men with permissible attitudes towards VAW were two times more likely to perpetrate IPV . Having gender equitable attitudes reduced a man\u2019s likelihood of perpetrating IPV (OR = 0.91 CI: 0.88\u20130.94). However, there were no significant differences in what the respondents indicated were community gender norms between perpetrators and non-perpetrators. Controlling behaviour was also found to be significantly associated with IPV perpetration, with the odds of IPV perpetration increasing with increase in controlling behaviour (OR = 1.06 CI:1.02\u20131.09).Of the men who provided information about their partner, partner unemployment and partner education were most significant factors associated with IPV perpetration. Men with partners who were more educated than them were more likely to perpetrate IPV compared to men who had the same education levels with their partners (OR = 1.75 CI: 1.24\u20132.47). Most of the men (181/206) with more educated partners had junior secondary school level or lower. A man with an unemployed partner was two times more likely to perpetrate IPV than a man whose partner was employed (OR = 1.70 CI:1.30\u20132.22).In the multivariate logistic regression , childhoOur findings show high levels of sexual or physical IPV perpetration in the selected communities in Ghana with one in five men having perpetrated sexual or physical IPV in the 12 months preceding the survey, and one in ten men having perpetrated physical IPV in 12 months preceding the survey. Sexual IPV prevalence was higher than physical IPV prevalence, and not all perpetrators used all types of violence. However, there was some overlap between sexual and physical IPV, with 6% of the men perpetrating both sexual and physical IPV in the 12 months preceding the survey. Findings from the UN Multi-country study showed variation in the occurrence of sexual or physical IPV with some countries having higher prevalence of sexual IPV than physical IPV and other countries having higher physical IPV prevalence compared to sexual IPV . There aFor lifetime prevalence rates, almost one in every three men had perpetrated some form of physical IPV. Our lifetime prevalence rates are far much higher than findings by Kishor and Bradley, who using data from nationally representative Demographic and Health Surveys in Ghana found a lifetime physical IPV perpetration of 16.3% . HoweverIn this paper, we found that having witnessed abuse of one\u2019s mother increases the risk of IPV perpetration in adulthood. The very significant association between witnessing inter-parental violence and having attitudes that endorse VAW bridges the link between exposure to violence in childhood and IPV perpetration later in life. This is consistent with other studies that have looked at inter-generational transmission of VAW , 41\u201343. In the crude bivariate analysis, both gender attitude measure from the GEM scale and individual attitudes score were strongly associated with IPV perpetration and perceived community gender attitudes was marginally significant. In the multivariate analysis, only individual attitudes were significantly associated with IPV perpetration. However, there was a very strong positive correlation between GEM score and individual gender attitudes score, which might explain the non-significant relationship between GEM score and IPV perpetration in the multivariate model. Our findings are in line with several studies that have found a relationship between gender attitudes and IPV perpetration or experience , 14, 27.Field and colleagues found alcohol consumption was a more influential predictor of IPV perpetration than permissible attitudes towards violence . Apart fBivariate analysis further showed a strong relationship between IPV perpetration and woman\u2019s education level relative to their partner\u2019s education level, with men whose partners were more educated than them having high likelihood of perpetrating IPV. In a study done in India, Ackerson and colleagues found increased likelihood of IPV experience among women with no education but also in women who were more educated than their partner .Findings from the Ghana 2008 DHS showed that women with tertiary education had decreased likelihood of experiencing IPV. HoweverOur study found strong association between risky sexual behaviours  and IPV perpetration, a finding consistent with that of other studies that have looked at risk factors for IPV perpetration/experience and generally interpreted these as indicator variables for a more patriarchal, sexually entitled masculinity , 17, 28.Having an unemployed partner increased men\u2019s likelihood of perpetrating IPV. Several studies have shown that female empowerment through education or income is generally protective against IPV , 13. HigA major limitation of our study is the non-response to partner\u2019s characteristics. Information on partner characteristics would have helped in linking IPV perpetration with women\u2019s characteristics relative to men\u2019s. Another limitation of our study is the unavailability of data at community level that could have helped us understand society-level drivers of IPV perpetration. The findings of this study cannot to be generalised to the whole of Ghana, but provide much needed empirical evidence on which primary VAW prevention interventions can be based, and act as a reference level for the Rural Response System (RRS) intervention to reduce gender-based violence currently ongoing in the districts where the survey was conducted. Based on the cross-sectional study design, we are also mindful that it is not possible to infer causal relationships between IPV perpetration and the risk factors examined in our paper.The study contributes important evidence about factors associated with men\u2019s IPV perpetration in Ghana, and complements findings from studies conducted amongst women. Findings of this study emphasise the urgent need for primary prevention interventions that can address inter-generational transmission of violence and address learned gender inequitable attitudes and norms that condone men\u2019s control and dominance over women. Interrupting the cycle of violence is very critical in reducing men\u2019s perpetration of VAW. Context-specific evidence is critical for designing appropriate and relevant interventions and policies. We also argue that it may be necessary for VAW primary prevention interventions to take into account contextual challenges like poverty and unemployment .S1 File(CSV)Click here for additional data file."]}
{"representative": "Intimate partner violence (IPV) is exceedingly common in conflict and post-conflict settings. We first seek to describe factors associated with past 12\u00a0month IPV amongst currently married women in Afghanistan, focused on the factors typically assumed to drive IPV. Second, to describe whether IPV is independently associated with a range of health outcomes.Cross-sectional analysis of currently married Afghan women, comprising the baseline study of a trial to prevent IPV. We use multinomial regression, reporting adjusted relative-risk ratios to model factors associated with the different forms of IPV, comparing no IPV, emotional IPV only, and physical IPV and emotional IPV. Second we assessed whether experience of emotional IPV, and physical IPV, were independently associated with health outcomes, reporting adjusted \u00df coefficients and adjusted odds ratios as appropriate.Nine hundred thirty five currently married women were recruited, 11.8% experienced only emotional IPV and 23.1% experienced physical and emotional IPV. Emotional IPV only was associated with attending a women\u2019s group, greater food insecurity, her husband having more than one wife, experiencing other forms of family violence, and more inequitable community gender norms. Experiencing both physical IPV and emotional IPV was associated with attending a women\u2019s group, more childhood trauma, husband cruelty, her husband having more than one wife, experiencing other forms of family violence, more inequitable community gender norms, and greater reported disability. Emotional IPV and physical IPV were independently associated with worse health outcomes.IPV remains common in Afghanistan. Economic interventions for women alone are unlikely to prevent IPV and potentially may increase IPV. Economic interventions need to also work with husbands and families, and work to transform community level gender norms.NCT03236948. Registered 28 July 2017, retrospectively registered. Intimate partner violence (IPV) is common in both conflict and post-conflict settings, but there remains little evidence about the extent of IPV in such settings , 2. For Global research on risk factors for IPV have focused on individual characteristics, partner characteristics, poverty, and community attitudes . IndividCharacteristics of women\u2019s male partners are important in shaping women\u2019s vulnerability to IPV. Men who are more controlling, who are more patriarchal in their attitudes and practices , 16, andHousehold economic position is also important in women\u2019s experiences of IPV. Household food insecurity is often a key marker of IPV vulnerability, even in high-income countries , 21. OthFinally, community level analyses have consistently shown that where IPV is normative at the community level, women are more likely to experience IPV . But, inIPV is associated with women\u2019s poor health. Women who experience IPV are more likely to be depressed, suicidal, have post-traumatic stress disorder (PTSD), and have overall worse health , 25. TheThis paper has two aims. First, to describe the factors associated with recent IPV amongst a group of currently married women in Afghanistan, focused on the factors typically assumed to drive IPV. Second, to describe whether IPV is independently associated with health outcomes amongst these married women.Data are drawn from currently married women participating in the baseline assessment of the Women for Women International (WfWI) intervention trial, in Afghanistan, enrolled between September 2016 and March 2017. The study comprised six villages in Kabul and Nangarhar Provinces.Women were aged 18 to 49. The study aimed to recruit among the poorest women in villages, and those without much formal education, and not currently working or earning much money. In the main study, women were recruited no matter their marital status, but in this analysis only married women are included, as it is not possible to ask about IPV to women who are not currently married.Women were randomized at the individual level to intervention and control arms, and were aware of arm allocation when completing questionnaires. For questionnaire completion, women in the control arm received US$10, while women in the intervention received no compensation (however they did receive the intervention). The intervention was delivered after baseline data collection, and seeks to strengthen livelihoods and social empowerment , 32. EthStructured paper and pencil questionnaires were completed through face-to-face interviews. Fieldworkers were women trained in quantitative interviewing. Interviews were conducted in training centres in villages, a space only women could enter, where auditory privacy could be ensured.Data was double-entered into a database. Discrepancies between the databases were resolved through manual checking of the original questionnaire. Missing data was imputed for scales. The mean of the item for the overall sample was used to impute data and no more than two items were imputed per individual, per scale. If three or more items were missing from a scale for an individual, the scale was set to missing for that person.The primary outcome was past year IPV and only married women were asked these questions. Emotional IPV and physical IPV were assessed using scales based on the WHO Multi-Country study on Domestic Violence , adaptedSocio-demographic questions were asked, including ethnic group, age, marital status and education level. Women were asked a single item about participation in a women\u2019s group, specifically \u201cDo you attend a group where women meet together to do something to earn money or to improve the community or for social reasons in the village?\u201d Women\u2019s gender attitudes were assessed using 11 items, on the gender equity scale, modified for use in Afghanistan (\u03b1\u2009=\u20090.87), with a typical item being \u201cI think girls in my family should go to school\u201d. Items were summed together (range 14\u201332), with higher scores indicating less gender equitable attitudes. Childhood traumas were assessed using 12 items based on the\u00a0childhood trauma scale  adapted Poverty was assessed in two ways. Household food insecurity was assessed with three items of the Household Hunger Scale (\u03b1\u2009=\u20090.94), assessing past month food insecurity, which was summed (range 3\u201312) . One iteHousehold relationships were assessed in three different ways. First women were asked whether they were their husband\u2019s only wife. Second, a five-item scale assessed husband cruelty, with questions including \u201cmy husband is strict and controlling\u201d. Responses were on a four-point Likert scale and summed . Finally, to assess violence in the home from other family members, women were asked three questions about violence experienced from other household members; mother-in-law, father, or a sibling, all in the past year. A positive response to any of these items led to women being classified as having experienced violence from another family member.Perceived community level gender attitudes were assessed using 11 items. Community level gender attitudes were assessed through the same questions as individual level gender attitudes, but instead of \u201cI think\u201d, questions were \u201cIn this community many people think\u201d .Six health and wellbeing measures were assessed. Past week depression was assessed with CESD-20  and scorn\u2009=\u200917) had only experienced physical IPV, but not emotional IPV, and were excluded from analysis. For the categorical variables, proportions of the sample with each level of the variable by IPV category are presented. For continuous variables, the mean for each experience category are presented. We used Chi-square tests to compare distributions across categorical variables and present 95% confidence intervals (CIs) to enable comparison of means, as appropriate, by IPV category. All variables were selected based on an a priori hypothesis that they may be associated with IPV, based on previous research on risk factors for IPV, summarized in the introduction.We first describe the socio-demographic characteristics, livelihoods, and experiences of IPV of the sample used for the analysis with percentages and means. As there is significant overlap between the different forms of IPV, we created a three-level categorization; women experiencing no IPV; those experiencing one or more instances of emotional IPV ; and those who experienced both physical IPV and emotional IPV. Only 1.8%  we categorsied women\u2019s experience of IPV in two ways. First, we considered the health impacts with IPV categorized as for the above model: no IPV, one or more experiences of\u00a0emotional IPV\u00a0only, and one or more experiences of\u00a0physical IPV and one or more experiences of\u00a0emotional IPV. In Table\u00a0In total, 935 currently married women were recruited into the evaluation Table\u00a0. Of thesThere were low levels of education, with two-thirds having attended no schooling, and 13% only madrasaIPV experience did not differ by age and education category Table\u00a0. A higheAt the individual level, a higher percentage of women reporting emotional IPV, and those reporting physical and emotional IPV, reported being currently part of a savings group, or women\u2019s group. Women reporting experiencing both physical and emotional IPV reported more inequitable gender attitudes and more experiences of childhood traumas, than those reporting no IPV, and the 95%CIs did not overlap. Women reporting emotional IPV only and physical and emotional IPV reported a higher mean score for food insecurity compared to those reporting no IPV, and 95%CIs did not overlap.At the family level, a larger proportion of women reporting their husband had more than one wife, reported emotional IPV, and physical and emotional IPV. Women reporting physical and emotional IPV reported higher means scores for husband cruelty, than women with no IPV experience. And a higher proportion of women reporting emotional IPV, and physical and emotional IPV, reported experiencing violence from another family member. Women who experienced emotional IPV, and physical and emotional IPV, reported higher gender inequitable community attitudes, than those reporting no IPV. For health related factors, women reporting only emotional IPV, and physical and emotional IPV, reported more depressive symptoms, and higher mean scores for disability, than those reporting no IPV, with no overlap with 95%CIs.In the multinomial regression Table\u00a0, women oExperiencing physical and emotional IPV, compared to no IPV, was associated with participation in a women\u2019s group, having higher levels of childhood trauma, reporting their husband had more than one wife, higher levels of husband cruelty, experiencing violence from another family member, and increased perceptions of gender inequitable attitudes at the community level. Women who reported greater levels of disability also reported more physical IPV and emotional IPV.Table In our sample, about a quarter of currently married women reported any physical IPV in the past year, and just over a third reported emotional and/or physical IPV in the past year. Almost all those who experienced physical IPV, also experienced emotional IPV. Factors associated with women experiencing emotional IPV only, and physical IPV and emotional IPV, were very similar in the multinomial model, where typically women reporting physical and emotional IPV experience, compared to emotional IPV only, had larger adjusted relative-risk ratios.Not all factors associated with women\u2019s experience of emotional IPV, were associated with women\u2019s experience of physical and emotional IPV. Specifically, food insecurity was only associated with experiencing only emotional IPV, but not physical and emotional IPV, and childhood traumas were only associated with experience of physical and emotional IPV, and not emotional IPV only. There are a number of potential reasons for this. Emotional IPV, while strongly overlapping with physical IPV, is a different construct , and as Women\u2019s experience of both emotional IPV only, and physical IPV and emotional IPV, were associated with involvement in women\u2019s groups outside the home. It may be women who experience IPV opt into women\u2019s groups, more than women who do not experience IPV, as a way to build resources and social networks and work to ameliorate the impact of IPV, enabling resilience in the face of trauma . AlternaExperience of childhood traumas were associated with experiencing physical IPV and emotional IPV, but not emotional IPV only. The importance of childhood traumas in shaping IPV experience is recognised in a variety of contexts . AfghaniNo markers of poverty were consistently associated with IPV. Food insecurity was only associated with emotional IPV in the multinomial model. There was no evidence that earnings had any association with IPV. This is in contrast to much research that suggests poverty is a driver of women\u2019s experiences of IPV . There aThe family structure and dynamics were important for women\u2019s experience of IPV. Women reporting more husband cruelty, were more likely to experience physical and emotional IPV. This reflects the importance of male power in shaping women\u2019s experiences of IPV , 43, andWomen reporting their husband had more than one wife were more likely to experience emotional IPV, and physical and emotional IPV. Qualitative research suggests multiple wives living under one roof, may experience increased levels of competition between wives, around positioning in the household structure, and men may struggle to manage this dynamic, increasing conflict . In addiThe importance of findings about household structure and dynamics and its relationship to IPV, is it questions the narrow focus on dyadic models of IPV (i.e. violence between husband and wives). The assumption IPV is a dyadic phenomenon emerges from research in high-income countries, with a narrow interpretation of social relationships within the home. It does not recognise that in many households there are multiple generations and that gender and age hierarchies shape relationships, and power is contested between women, and not only between women and men.Community level inequitable gender attitudes were associated with emotional IPV, and physical and emotional IPV. Studies elsewhere have shown that community level attitudes to gender and acceptability of IPV have an independent impact on women\u2019s experiences of IPV . InterveSeverity of disability was a \u2018driver\u2019 of physical and emotional IPV and a consequence in this study. Disabled women globally experience increased vulnerability to IPV, because of gender inequalities, disability stigma and discrimination, and increased economic dependency on partners and caregivers , 49, butThe analysis showed women\u2019s experience of emotional IPV had an independent association with a range of health outcomes, particularly when it was severe (two or more episodes) emotional IPV. This supports the limited body of evidence that shows emotional IPV has an independent impact on women\u2019s health, over and above physical IPV , 30. Desn\u2009=\u200917) women had only experienced physical IPV and not emotional IPV, and these women were excluded from analysis. As data are cross-sectional temporal associations between factors are unclear. Women self-selected into the study, and therefore this is not generalizable to the population-level.The study has limitations. Very few (We show a complex picture about the appropriate nature of interventions to prevent IPV in Afghanistan. In contrast to reviews showing the importance of economic empowerment interventions to reduce women\u2019s experiences of IPV , 50, our", "texts": ["Intimate partner violence (IPV) is exceedingly common in conflict and post-conflict settings. We first seek to describe factors associated with past 12\u00a0month IPV amongst currently married women in Afghanistan, focused on the factors typically assumed to drive IPV. Second, to describe whether IPV is independently associated with a range of health outcomes.Cross-sectional analysis of currently married Afghan women, comprising the baseline study of a trial to prevent IPV. We use multinomial regression, reporting adjusted relative-risk ratios to model factors associated with the different forms of IPV, comparing no IPV, emotional IPV only, and physical IPV and emotional IPV. Second we assessed whether experience of emotional IPV, and physical IPV, were independently associated with health outcomes, reporting adjusted \u00df coefficients and adjusted odds ratios as appropriate.Nine hundred thirty five currently married women were recruited, 11.8% experienced only emotional IPV and 23.1% experienced physical and emotional IPV. Emotional IPV only was associated with attending a women\u2019s group, greater food insecurity, her husband having more than one wife, experiencing other forms of family violence, and more inequitable community gender norms. Experiencing both physical IPV and emotional IPV was associated with attending a women\u2019s group, more childhood trauma, husband cruelty, her husband having more than one wife, experiencing other forms of family violence, more inequitable community gender norms, and greater reported disability. Emotional IPV and physical IPV were independently associated with worse health outcomes.IPV remains common in Afghanistan. Economic interventions for women alone are unlikely to prevent IPV and potentially may increase IPV. Economic interventions need to also work with husbands and families, and work to transform community level gender norms.NCT03236948. Registered 28 July 2017, retrospectively registered. Intimate partner violence (IPV) is common in both conflict and post-conflict settings, but there remains little evidence about the extent of IPV in such settings , 2. For Global research on risk factors for IPV have focused on individual characteristics, partner characteristics, poverty, and community attitudes . IndividCharacteristics of women\u2019s male partners are important in shaping women\u2019s vulnerability to IPV. Men who are more controlling, who are more patriarchal in their attitudes and practices , 16, andHousehold economic position is also important in women\u2019s experiences of IPV. Household food insecurity is often a key marker of IPV vulnerability, even in high-income countries , 21. OthFinally, community level analyses have consistently shown that where IPV is normative at the community level, women are more likely to experience IPV . But, inIPV is associated with women\u2019s poor health. Women who experience IPV are more likely to be depressed, suicidal, have post-traumatic stress disorder (PTSD), and have overall worse health , 25. TheThis paper has two aims. First, to describe the factors associated with recent IPV amongst a group of currently married women in Afghanistan, focused on the factors typically assumed to drive IPV. Second, to describe whether IPV is independently associated with health outcomes amongst these married women.Data are drawn from currently married women participating in the baseline assessment of the Women for Women International (WfWI) intervention trial, in Afghanistan, enrolled between September 2016 and March 2017. The study comprised six villages in Kabul and Nangarhar Provinces.Women were aged 18 to 49. The study aimed to recruit among the poorest women in villages, and those without much formal education, and not currently working or earning much money. In the main study, women were recruited no matter their marital status, but in this analysis only married women are included, as it is not possible to ask about IPV to women who are not currently married.Women were randomized at the individual level to intervention and control arms, and were aware of arm allocation when completing questionnaires. For questionnaire completion, women in the control arm received US$10, while women in the intervention received no compensation (however they did receive the intervention). The intervention was delivered after baseline data collection, and seeks to strengthen livelihoods and social empowerment , 32. EthStructured paper and pencil questionnaires were completed through face-to-face interviews. Fieldworkers were women trained in quantitative interviewing. Interviews were conducted in training centres in villages, a space only women could enter, where auditory privacy could be ensured.Data was double-entered into a database. Discrepancies between the databases were resolved through manual checking of the original questionnaire. Missing data was imputed for scales. The mean of the item for the overall sample was used to impute data and no more than two items were imputed per individual, per scale. If three or more items were missing from a scale for an individual, the scale was set to missing for that person.The primary outcome was past year IPV and only married women were asked these questions. Emotional IPV and physical IPV were assessed using scales based on the WHO Multi-Country study on Domestic Violence , adaptedSocio-demographic questions were asked, including ethnic group, age, marital status and education level. Women were asked a single item about participation in a women\u2019s group, specifically \u201cDo you attend a group where women meet together to do something to earn money or to improve the community or for social reasons in the village?\u201d Women\u2019s gender attitudes were assessed using 11 items, on the gender equity scale, modified for use in Afghanistan (\u03b1\u2009=\u20090.87), with a typical item being \u201cI think girls in my family should go to school\u201d. Items were summed together (range 14\u201332), with higher scores indicating less gender equitable attitudes. Childhood traumas were assessed using 12 items based on the\u00a0childhood trauma scale  adapted Poverty was assessed in two ways. Household food insecurity was assessed with three items of the Household Hunger Scale (\u03b1\u2009=\u20090.94), assessing past month food insecurity, which was summed (range 3\u201312) . One iteHousehold relationships were assessed in three different ways. First women were asked whether they were their husband\u2019s only wife. Second, a five-item scale assessed husband cruelty, with questions including \u201cmy husband is strict and controlling\u201d. Responses were on a four-point Likert scale and summed . Finally, to assess violence in the home from other family members, women were asked three questions about violence experienced from other household members; mother-in-law, father, or a sibling, all in the past year. A positive response to any of these items led to women being classified as having experienced violence from another family member.Perceived community level gender attitudes were assessed using 11 items. Community level gender attitudes were assessed through the same questions as individual level gender attitudes, but instead of \u201cI think\u201d, questions were \u201cIn this community many people think\u201d .Six health and wellbeing measures were assessed. Past week depression was assessed with CESD-20  and scorn\u2009=\u200917) had only experienced physical IPV, but not emotional IPV, and were excluded from analysis. For the categorical variables, proportions of the sample with each level of the variable by IPV category are presented. For continuous variables, the mean for each experience category are presented. We used Chi-square tests to compare distributions across categorical variables and present 95% confidence intervals (CIs) to enable comparison of means, as appropriate, by IPV category. All variables were selected based on an a priori hypothesis that they may be associated with IPV, based on previous research on risk factors for IPV, summarized in the introduction.We first describe the socio-demographic characteristics, livelihoods, and experiences of IPV of the sample used for the analysis with percentages and means. As there is significant overlap between the different forms of IPV, we created a three-level categorization; women experiencing no IPV; those experiencing one or more instances of emotional IPV ; and those who experienced both physical IPV and emotional IPV. Only 1.8%  we categorsied women\u2019s experience of IPV in two ways. First, we considered the health impacts with IPV categorized as for the above model: no IPV, one or more experiences of\u00a0emotional IPV\u00a0only, and one or more experiences of\u00a0physical IPV and one or more experiences of\u00a0emotional IPV. In Table\u00a0In total, 935 currently married women were recruited into the evaluation Table\u00a0. Of thesThere were low levels of education, with two-thirds having attended no schooling, and 13% only madrasaIPV experience did not differ by age and education category Table\u00a0. A higheAt the individual level, a higher percentage of women reporting emotional IPV, and those reporting physical and emotional IPV, reported being currently part of a savings group, or women\u2019s group. Women reporting experiencing both physical and emotional IPV reported more inequitable gender attitudes and more experiences of childhood traumas, than those reporting no IPV, and the 95%CIs did not overlap. Women reporting emotional IPV only and physical and emotional IPV reported a higher mean score for food insecurity compared to those reporting no IPV, and 95%CIs did not overlap.At the family level, a larger proportion of women reporting their husband had more than one wife, reported emotional IPV, and physical and emotional IPV. Women reporting physical and emotional IPV reported higher means scores for husband cruelty, than women with no IPV experience. And a higher proportion of women reporting emotional IPV, and physical and emotional IPV, reported experiencing violence from another family member. Women who experienced emotional IPV, and physical and emotional IPV, reported higher gender inequitable community attitudes, than those reporting no IPV. For health related factors, women reporting only emotional IPV, and physical and emotional IPV, reported more depressive symptoms, and higher mean scores for disability, than those reporting no IPV, with no overlap with 95%CIs.In the multinomial regression Table\u00a0, women oExperiencing physical and emotional IPV, compared to no IPV, was associated with participation in a women\u2019s group, having higher levels of childhood trauma, reporting their husband had more than one wife, higher levels of husband cruelty, experiencing violence from another family member, and increased perceptions of gender inequitable attitudes at the community level. Women who reported greater levels of disability also reported more physical IPV and emotional IPV.Table In our sample, about a quarter of currently married women reported any physical IPV in the past year, and just over a third reported emotional and/or physical IPV in the past year. Almost all those who experienced physical IPV, also experienced emotional IPV. Factors associated with women experiencing emotional IPV only, and physical IPV and emotional IPV, were very similar in the multinomial model, where typically women reporting physical and emotional IPV experience, compared to emotional IPV only, had larger adjusted relative-risk ratios.Not all factors associated with women\u2019s experience of emotional IPV, were associated with women\u2019s experience of physical and emotional IPV. Specifically, food insecurity was only associated with experiencing only emotional IPV, but not physical and emotional IPV, and childhood traumas were only associated with experience of physical and emotional IPV, and not emotional IPV only. There are a number of potential reasons for this. Emotional IPV, while strongly overlapping with physical IPV, is a different construct , and as Women\u2019s experience of both emotional IPV only, and physical IPV and emotional IPV, were associated with involvement in women\u2019s groups outside the home. It may be women who experience IPV opt into women\u2019s groups, more than women who do not experience IPV, as a way to build resources and social networks and work to ameliorate the impact of IPV, enabling resilience in the face of trauma . AlternaExperience of childhood traumas were associated with experiencing physical IPV and emotional IPV, but not emotional IPV only. The importance of childhood traumas in shaping IPV experience is recognised in a variety of contexts . AfghaniNo markers of poverty were consistently associated with IPV. Food insecurity was only associated with emotional IPV in the multinomial model. There was no evidence that earnings had any association with IPV. This is in contrast to much research that suggests poverty is a driver of women\u2019s experiences of IPV . There aThe family structure and dynamics were important for women\u2019s experience of IPV. Women reporting more husband cruelty, were more likely to experience physical and emotional IPV. This reflects the importance of male power in shaping women\u2019s experiences of IPV , 43, andWomen reporting their husband had more than one wife were more likely to experience emotional IPV, and physical and emotional IPV. Qualitative research suggests multiple wives living under one roof, may experience increased levels of competition between wives, around positioning in the household structure, and men may struggle to manage this dynamic, increasing conflict . In addiThe importance of findings about household structure and dynamics and its relationship to IPV, is it questions the narrow focus on dyadic models of IPV (i.e. violence between husband and wives). The assumption IPV is a dyadic phenomenon emerges from research in high-income countries, with a narrow interpretation of social relationships within the home. It does not recognise that in many households there are multiple generations and that gender and age hierarchies shape relationships, and power is contested between women, and not only between women and men.Community level inequitable gender attitudes were associated with emotional IPV, and physical and emotional IPV. Studies elsewhere have shown that community level attitudes to gender and acceptability of IPV have an independent impact on women\u2019s experiences of IPV . InterveSeverity of disability was a \u2018driver\u2019 of physical and emotional IPV and a consequence in this study. Disabled women globally experience increased vulnerability to IPV, because of gender inequalities, disability stigma and discrimination, and increased economic dependency on partners and caregivers , 49, butThe analysis showed women\u2019s experience of emotional IPV had an independent association with a range of health outcomes, particularly when it was severe (two or more episodes) emotional IPV. This supports the limited body of evidence that shows emotional IPV has an independent impact on women\u2019s health, over and above physical IPV , 30. Desn\u2009=\u200917) women had only experienced physical IPV and not emotional IPV, and these women were excluded from analysis. As data are cross-sectional temporal associations between factors are unclear. Women self-selected into the study, and therefore this is not generalizable to the population-level.The study has limitations. Very few (We show a complex picture about the appropriate nature of interventions to prevent IPV in Afghanistan. In contrast to reviews showing the importance of economic empowerment interventions to reduce women\u2019s experiences of IPV , 50, our"]}
{"representative": "Intimate partner violence (IPV) has been increasingly recognised as a major public health and human rights problem that cuts across all populations, irrespective of social, economic, religious or cultural groups.The objectives of this study were to determine the prevalence, pattern and correlates of IPV among women attending the General Out Patient Clinic of Aminu Kano Teaching Hospital, Kano, Nigeria. It was also designed to determine the pattern of health complications associated with IPV as well as the perception of women on intimate partner violence.This was a cross-sectional, hospital-based study. Three hundred and ninety-three women aged 15\u201349 years who were in or had ever been in an intimate relationship were recruited. An interviewer-administered questionnaire was used to collect data about their socio-demographic characteristics while information on IPV was obtained using the Composite Abuse Scale. The data were analysed using the Statistical Package for Social Science (SPSS) version 16.0.\u03c72 = 24.726, p = 0.000) and pregnancy reduced the risk of IPV , while polygamous family setting  and an extended family type  were associated with an increased risk of IPV. Alcohol consumption by the partner  was found to be a positive correlate as well as a complication of IPV. Other patterns of health complications that were significantly associated with IPV were depression , miscarriage  and the presence of physical injuries in the participants . One hundred and fifty-nine (40.5%) of the participants agreed that a husband is justified for beating or hitting his wife and neglecting the child was the reason given by most of the participants (26.7%) to justify IPV.The prevalence of IPV within the previous year was 42.0%. Of all the 393 participants recruited in the study, 46.6% had experienced emotional/psychological violence, harassment/controlling behaviour was present in 43.3%, physical violence was reported in 29.0%, sexual violence was present in 21.9% and 37.9% of the participants had experienced severe combined abuse. Being married (The high prevalence of IPV among women of reproductive age in this study shows that it is an important problem that women would rather not talk about or have accepted as a norm. It is associated with poor physical and mental health of women who are victims.It is therefore recommended that physicians routinely screen for IPV especially in patients with depressive symptoms, miscarriage and physical injuries. Screening will be a safe and cost-effective means for identifying women experiencing IPV, leading to appropriate interventions that will decrease further exposure to IPV and its adverse health consequences. Intimate partners may be cohabiting, but need not be.2 Violence against women is the most pervasive and yet under-recognised human rights violation in the world. It is also a profound health problem that saps women\u2019s energy, compromises their physical and mental health, erodes their self-esteem and prevents them from achieving their full potential.3Intimate partner violence (IPV) has been defined as behaviours within an intimate relationship that cause physical, psychological or sexual harm to those in the relationship, including acts of physical aggression, sexual coercion, psychological abuse and controlling behaviours.4 A cross-sectional study by Zungu et al. 2010 on IPV among women attending a public hospital in Botswana showed the lifetime and past-year prevalence of IPV to be 49.7% and 21.2% respectively.5In 48 population-based surveys from around the world, between 10% and 69% of women reported being physically assaulted by an intimate male partner at some point in their lives, and that 15% \u2013 30% had been assaulted in the previous year.6 the northern part of the country, reported a prevalence of 31.8% among pregnant women, while Iliyasu et al. in Kano found a prevalence of 58.8% among female university students in Northern Nigeria.7 In a cross-sectional study carried out among a sample of women attending a primary health centre in Ile-Ife, south-western Nigeria, the prevalence of IPV in the previous 12 months was found to be 36.7%.8 A similar study on IPV among women of childbearing age in a primary health care centre in eastern Nigeria, reported a prevalence of 46.3% for the previous 12 months.9In Nigeria, studies on the prevalence of IPV have reported a wide range of values. A cross-sectional study by Envuladu et al. in Jos,1IPV is not simply a matter of family privacy, individual choice or inevitable facet of life. It is a complex problem related to patterns of thought and behaviour that are shaped by a multitude of forces within families and communities.10 There is a paucity of data on the pattern and extent of IPV in the region.In Nigeria, some women justify domestic violence perpetrated by husbands depending on the situation. In the 2003 Nigerian Demographic Health Survey, 64.5% of women and 61.3% of men were reported to support wife beating in at least one of the six scenarios described in the survey.This was a cross-sectional, descriptive, hospital-based study carried out between 1st August and 30th September, 2015, at the General Out-Patient Clinic (GOPC) of the Family Medicine Department of Aminu Kano Teaching Hospital (AKTH), Kano, Nigeria. The aim and objectives of the study were read to eligible participants, whence a voluntary, written informed consent was obtained from each participant.The study population consisted of all women aged 15\u201349 years who were in or had ever been in an intimate relationship, presenting to the GOPC of AKTH.8Through a systematic, random sampling 393 women were recruited for this study.11Sample size was calculated using the formula:n = Z2 p q /d2\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0[Eqn 1]n = the desired minimum sample size (when population is greater than 10 000), Z = the standard normal deviation, set at 1.96 which corresponds to 95% confidence interval, p = prevalence of IPV among women attending a primary health centre in Ile-Ife = 36.7%,8q = 1 \u2013 p = 0.633, d = level of precision usually set at 5% = 0.05.where n = (1.96)2 \u00d7 0.367 \u00d7 0.633/(0.05)2 = (1.96)2 \u00d7 0.2323/0.0025 = 0.8924/0.0025 = 356.96 \u2248 357 participants.Therefore, Ten per cent of the calculated minimum sample size (36 women) was added to account for attrition, missing or incomplete data. Thus, the number of women to be recruited for this study will be 357 + 36 = 393 participants.Participants were included if they consented and were aged 15\u201349 years, currently married, divorced, or involved in an intimate relationship. Women with known psychiatric illness were excluded because their concentration, memory and judgement could be impaired.12 The CAS consists of 30 items presented in a six-point format requiring respondents to answer \u2018never\u2019, \u2018only once\u2019, \u2018several times\u2019, \u2018monthly\u2019, \u2018weekly\u2019 or \u2018daily\u2019 in a 12-month period. A preliminary cut-off score of 7 divides respondents into abused and non-abused. Preliminary recommended cut-off scores for the individual subscales are as follows: Physical Abuse (I), Emotional Abuse (3), Harassment (2), Sexual abuse (1) and Severe Combined Abuse (I). Information on the perception of women on IPV was assessed using extracts from the 2003 Nigeria Demographic and Health Survey model questionnaire which has a number of questions about the perception of women on intimate partner violence.10 The Patient Health Questionnaire-2 (PHQ-2) was used to screen for depression among the respondents.A pre-tested, structured questionnaire was administered by the investigator to eligible women after obtaining informed consent from individual participants. Information on IPV was obtained using the Composite Abuse Scale (CAS).p-value of less than or equal to 0.05 was considered statistically significant.All data collected were analysed using Statistical Package for Social Science (SPSS) version 16.0 software. The Chi square test was used to assess the associations of demographic variables with type of violence. Logistic regression analysis was used to assess the correlates of intimate partner violence. A Ethical clearance for this study was sought and obtained from the Research Ethics Committee of AKTH, Kano, Nigeria.The age range of the study participants was between 16 and 45 years. The mean age was 27 (SD \u00b1 6.29) years and the modal age group was 25\u201334 years (47.3%).Other socio-demographic characteristics of the study participants are as shown in Of all the respondents, 165 (42.0%) had experienced a form of violence in the preceding 12 months while 228 (58.0%) had not experienced IPV in any form.Harassment/controlling behaviour was the most common form of violence experienced by 71 (43.3%) of the participants. Forty-eight (29.0%) had experienced physical violence, 36 (21.9%) had experienced sexual violence while 10 (5.8%) had experienced emotional/psychological violence. Sixty-three (38.2%) participants had experienced severe combined abuse.\u03c72 = 3.693, p = 0.254), ethnicity , religion , occupation  and level of education  were not significantly associated with IPV. However, the correlates found to be significantly associated with IPV on bivariate analysis were:The age of the participants . Being married reduced the risk of IPV while divorced women were more likely to have experienced IPV.Marital status: IPV was significantly associated with marital status . However, on further analysis, there was no significant independent association .Pregnancy status: There was an association between pregnancy status and IPV on bivariate analysis .Type of family setting: The polygamous family setting was associated with increased risk of IPV .Type of family: Extended family setting was associated with increased risk of IPV .Physical injury: There was an increased risk of sustaining physical injury following assault from an intimate partner. This association was found to be statistically significant . Women were at an increased risk of having a miscarriage following assault from their partners.Miscarriage: Miscarriage was significantly associated with IPV .Substance use by the respondents: There was an association between the increased use of substances such as sleeping pills and IPV .Alcohol use by the partner: Alcohol consumption by the partner was significantly associated with IPV .Depression: IPV was significantly associated with depression in women . Being overweight or obese increased the risk of IPV.Body mass index: Overweight and obesity were associated with IPV .Blood pressure: IPV is significantly associated with the development of hypertension in women  of the participants agreed that a husband is justified for beating or hitting his wife for at least one of the reasons asked. Neglecting the child was the reason given by most of the participants, 105 (26.7%), to justify wife beating while cooking meals late was the reason given by the least, 40 (10.2%), participants to justify wife beating. Two hundred and thirty-four (59.5%) of the participants did not think IPV was justified for any reason. The perception of participants on IPV is summarised in Health professionals are often the earliest point of contact for survivors of violence. Family physicians, through effective case management, co-ordinated and continuing care, can alleviate some of the negative effects of partner violence on women suffering in silence. In addition, through publications of research findings, family physicians can create awareness of the burden of the problem and as such promote advocacy for women empowerment.1 It is also similar to the prevalence of 45.6% in Africa.3 In Nigeria, a similar prevalence of 46.3% was reported by Ilika and colleagues in a clinic-based study among the Igbo community in Neni, Anambra State.9 Okenwa and colleagues reported a prevalence of 29% among women of childbearing age in Lagos, South west of Nigeria.13 The lower prevalence in their study could be due to the differences in methodology and the socio-cultural characteristics of the study populations. The prevalence of IPV reported in this study could still be underestimated because of beliefs that issues concerning families and intimate relationships should not be discussed as it is seen as a \u2018private matter\u2019.14The prevalence of IPV within the previous year in this study was 42.0% which is within the range of global estimates of IPV prevalence of between 20% and 50%.The present study measured four different patterns of IPV among all the participants (393) involved in the study.15 It is fairly higher than the reports of physical violence from Eastern Nigeria by Ilika et al. in Anambra State (15.8%) and Okemgbo et al. in Imo State (20.1%).16 These differences could be due to differences in cultural characteristics of the study populations. Northern Nigeria has a distinct culture and tradition of female seclusion (\u2018Purdah\u2019), practice of polygamy, forced marriages and desire for large families. In the Igbo tribe, it is culturally unacceptable to beat a pregnant or lactating mother.14 Based on comparison on studies about the association between pregnancy and IPV across the world, many studies reported that the association remains uncertain whether, in fact, the risk of IPV initiation or escalation increases, decreases or remains the same as a result of pregnancy. The reason that was advanced was that studies that examined the risk of IPV during pregnancy did not examine the patterns of IPV around the period of pregnancy through comparisons of IPV prevalence rates in the pre-pregnancy, pregnancy and post-pregnancy periods.18 IPV against women before pregnancy was a strong risk factor for abuse during pregnancy and after delivery, and abuse during a previous period was a strong indicator of subsequent abuse.18Physical violence: In the present study, 29.0% of the 393 participants experienced physical violence from their intimate partners. The result from this study is comparable with reports of physical violence by Iliyasu et al. in Kano (27.5%), and Gyuse and Ushie in Jos (26.5%).19 Although psychological violence was found to be the most prevalent form of IPV in the present study, it is still much higher than the 23.0% reported in a study by Okenwa and colleagues among women of childbearing age in Lagos, Nigeria, in which psychological violence was also the commonest form of IPV.13 Zungu et al. admitted the difficulty in measurement of psychological IPV due to diversity in cultures.5Emotional/psychological violence: In this study, 46.6% of the 393 participants experienced emotional violence which is comparable to the prevalence of 47.5% reported by Al-Nsour in Jordan and 50.8% reported by Iliyasu et al. among female university students in northern Nigeria.20 This wide range suggests a variation in the degree to which such behaviour is normative or acceptable in different cultures.Controlling behaviour/harassment: In this study, 43.3% of the 393 participants experienced controlling behaviour from their intimate partners. A study by Adebayo et al., in Lagos, Nigeria, found a higher prevalence (71.9%) among their study participants.1 The result is also consistent with prevalence rates reported in Imo state (21.3%), Kano (22.2%) and Lagos (21.0%).22 The prevalence in this study is higher than the prevalence reported from a study in Jos (10.7%), which was conducted among an obstetric population.15Sexual violence: In this study, 21.9% of the 393 participants experienced sexual violence which is within the range of 10% and 50% reported from the WHO Multicountry study.4 This may also be due to the patriarchal nature of Nigerian ethnic groups and religions.The differences in age, religion, ethnicity and educational level were not statistically significant in the present study. This may be related to the fact that IPV cuts across age, class, race, ethnicity, religion and national boundries.14 Another respondent in a focused group discussion by Odimegwu et al. among the Tiv in Nigeria was of the opinion that \u2018if you are not yet beaten by your husband, then you do not know the joy of marriage and that means you are not yet married\u2019.21 Thus, the perception of women to justify wife beating varies according to cultural norms and personal attributes, which suggests that designing an effective intervention to eliminate violence against women would require culturally acceptable programmes.This study revealed that a high percentage of the participants (40.5%) agreed that a husband is justified for hitting or beating his wife under the conditions examined in this study. The high level of support expressed for wife beating in this study confirms that violence against women is accepted as a cultural norm. A respondent from a focused group discussion by Ilika et al. among Igbo women of Ozubulu community in Anambra State was of the view that \u2018a woman deserves beating if she talked back on her husband, refused him sex, presented a poorly cooked food, or late meal, and failed to care for the children\u2019.This study revealed a high percentage (67.9%) of the victims of IPV sustained physical injuries such as bruises, red eyes, lacerations, etc, following assault from their partner. This is an expected finding given the high prevalence of IPV found in this study.4 IPV is an established risk factor for depression and depression has also been described as a health consequence of IPV.1 Thus, IPV can be conceptualised as a risk factor, correlate or outcome of substance use and depression. IPV being a significant cause of psychiatric illness in women, its exclusion in this study would tend to underestimate the prevalence that was reported. However, women with known psychiatric illness were excluded because their concentration, memory and judgement could be impaired, thus information obtained cannot be relied upon. Its exclusion is a limitation for this study.This study has found a significant positive association between IPV, depression and substance use among the victims of abuse. This finding is consistent with reports from similar studies within and outside Nigeria.This study found that women are at an increased risk of having a miscarriage following assault from their partners . This finding is consistent with the reports from the studies that showed that women with a history of physical or sexual abuse are also at an increased risk for unintended pregnancies, sexually transmitted diseases and miscarriages.1,The high prevalence of IPV among women of reproductive age in this study shows that it is an important problem that women would rather not talk about or have accepted as a norm. It is associated with poor physical and mental health of women who are victims.This study provides insight for policy makers, physicians and researchers who are attempting to tackle the global issue of IPV.It is therefore recommended that physicians routinely screen for IPV especially in patients with depressive symptoms, non-specific complaints, miscarriage and physical injuries on the face, trunk and upper limbs. Screening will be a safe and cost-effective means for identifying women experiencing IPV, leading to appropriate interventions that will decrease further exposure to IPV and its adverse health consequences.", "texts": ["Intimate partner violence (IPV) has been increasingly recognised as a major public health and human rights problem that cuts across all populations, irrespective of social, economic, religious or cultural groups.The objectives of this study were to determine the prevalence, pattern and correlates of IPV among women attending the General Out Patient Clinic of Aminu Kano Teaching Hospital, Kano, Nigeria. It was also designed to determine the pattern of health complications associated with IPV as well as the perception of women on intimate partner violence.This was a cross-sectional, hospital-based study. Three hundred and ninety-three women aged 15\u201349 years who were in or had ever been in an intimate relationship were recruited. An interviewer-administered questionnaire was used to collect data about their socio-demographic characteristics while information on IPV was obtained using the Composite Abuse Scale. The data were analysed using the Statistical Package for Social Science (SPSS) version 16.0.\u03c72 = 24.726, p = 0.000) and pregnancy reduced the risk of IPV , while polygamous family setting  and an extended family type  were associated with an increased risk of IPV. Alcohol consumption by the partner  was found to be a positive correlate as well as a complication of IPV. Other patterns of health complications that were significantly associated with IPV were depression , miscarriage  and the presence of physical injuries in the participants . One hundred and fifty-nine (40.5%) of the participants agreed that a husband is justified for beating or hitting his wife and neglecting the child was the reason given by most of the participants (26.7%) to justify IPV.The prevalence of IPV within the previous year was 42.0%. Of all the 393 participants recruited in the study, 46.6% had experienced emotional/psychological violence, harassment/controlling behaviour was present in 43.3%, physical violence was reported in 29.0%, sexual violence was present in 21.9% and 37.9% of the participants had experienced severe combined abuse. Being married (The high prevalence of IPV among women of reproductive age in this study shows that it is an important problem that women would rather not talk about or have accepted as a norm. It is associated with poor physical and mental health of women who are victims.It is therefore recommended that physicians routinely screen for IPV especially in patients with depressive symptoms, miscarriage and physical injuries. Screening will be a safe and cost-effective means for identifying women experiencing IPV, leading to appropriate interventions that will decrease further exposure to IPV and its adverse health consequences. Intimate partners may be cohabiting, but need not be.2 Violence against women is the most pervasive and yet under-recognised human rights violation in the world. It is also a profound health problem that saps women\u2019s energy, compromises their physical and mental health, erodes their self-esteem and prevents them from achieving their full potential.3Intimate partner violence (IPV) has been defined as behaviours within an intimate relationship that cause physical, psychological or sexual harm to those in the relationship, including acts of physical aggression, sexual coercion, psychological abuse and controlling behaviours.4 A cross-sectional study by Zungu et al. 2010 on IPV among women attending a public hospital in Botswana showed the lifetime and past-year prevalence of IPV to be 49.7% and 21.2% respectively.5In 48 population-based surveys from around the world, between 10% and 69% of women reported being physically assaulted by an intimate male partner at some point in their lives, and that 15% \u2013 30% had been assaulted in the previous year.6 the northern part of the country, reported a prevalence of 31.8% among pregnant women, while Iliyasu et al. in Kano found a prevalence of 58.8% among female university students in Northern Nigeria.7 In a cross-sectional study carried out among a sample of women attending a primary health centre in Ile-Ife, south-western Nigeria, the prevalence of IPV in the previous 12 months was found to be 36.7%.8 A similar study on IPV among women of childbearing age in a primary health care centre in eastern Nigeria, reported a prevalence of 46.3% for the previous 12 months.9In Nigeria, studies on the prevalence of IPV have reported a wide range of values. A cross-sectional study by Envuladu et al. in Jos,1IPV is not simply a matter of family privacy, individual choice or inevitable facet of life. It is a complex problem related to patterns of thought and behaviour that are shaped by a multitude of forces within families and communities.10 There is a paucity of data on the pattern and extent of IPV in the region.In Nigeria, some women justify domestic violence perpetrated by husbands depending on the situation. In the 2003 Nigerian Demographic Health Survey, 64.5% of women and 61.3% of men were reported to support wife beating in at least one of the six scenarios described in the survey.This was a cross-sectional, descriptive, hospital-based study carried out between 1st August and 30th September, 2015, at the General Out-Patient Clinic (GOPC) of the Family Medicine Department of Aminu Kano Teaching Hospital (AKTH), Kano, Nigeria. The aim and objectives of the study were read to eligible participants, whence a voluntary, written informed consent was obtained from each participant.The study population consisted of all women aged 15\u201349 years who were in or had ever been in an intimate relationship, presenting to the GOPC of AKTH.8Through a systematic, random sampling 393 women were recruited for this study.11Sample size was calculated using the formula:n = Z2 p q /d2\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0[Eqn 1]n = the desired minimum sample size (when population is greater than 10 000), Z = the standard normal deviation, set at 1.96 which corresponds to 95% confidence interval, p = prevalence of IPV among women attending a primary health centre in Ile-Ife = 36.7%,8q = 1 \u2013 p = 0.633, d = level of precision usually set at 5% = 0.05.where n = (1.96)2 \u00d7 0.367 \u00d7 0.633/(0.05)2 = (1.96)2 \u00d7 0.2323/0.0025 = 0.8924/0.0025 = 356.96 \u2248 357 participants.Therefore, Ten per cent of the calculated minimum sample size (36 women) was added to account for attrition, missing or incomplete data. Thus, the number of women to be recruited for this study will be 357 + 36 = 393 participants.Participants were included if they consented and were aged 15\u201349 years, currently married, divorced, or involved in an intimate relationship. Women with known psychiatric illness were excluded because their concentration, memory and judgement could be impaired.12 The CAS consists of 30 items presented in a six-point format requiring respondents to answer \u2018never\u2019, \u2018only once\u2019, \u2018several times\u2019, \u2018monthly\u2019, \u2018weekly\u2019 or \u2018daily\u2019 in a 12-month period. A preliminary cut-off score of 7 divides respondents into abused and non-abused. Preliminary recommended cut-off scores for the individual subscales are as follows: Physical Abuse (I), Emotional Abuse (3), Harassment (2), Sexual abuse (1) and Severe Combined Abuse (I). Information on the perception of women on IPV was assessed using extracts from the 2003 Nigeria Demographic and Health Survey model questionnaire which has a number of questions about the perception of women on intimate partner violence.10 The Patient Health Questionnaire-2 (PHQ-2) was used to screen for depression among the respondents.A pre-tested, structured questionnaire was administered by the investigator to eligible women after obtaining informed consent from individual participants. Information on IPV was obtained using the Composite Abuse Scale (CAS).p-value of less than or equal to 0.05 was considered statistically significant.All data collected were analysed using Statistical Package for Social Science (SPSS) version 16.0 software. The Chi square test was used to assess the associations of demographic variables with type of violence. Logistic regression analysis was used to assess the correlates of intimate partner violence. A Ethical clearance for this study was sought and obtained from the Research Ethics Committee of AKTH, Kano, Nigeria.The age range of the study participants was between 16 and 45 years. The mean age was 27 (SD \u00b1 6.29) years and the modal age group was 25\u201334 years (47.3%).Other socio-demographic characteristics of the study participants are as shown in Of all the respondents, 165 (42.0%) had experienced a form of violence in the preceding 12 months while 228 (58.0%) had not experienced IPV in any form.Harassment/controlling behaviour was the most common form of violence experienced by 71 (43.3%) of the participants. Forty-eight (29.0%) had experienced physical violence, 36 (21.9%) had experienced sexual violence while 10 (5.8%) had experienced emotional/psychological violence. Sixty-three (38.2%) participants had experienced severe combined abuse.\u03c72 = 3.693, p = 0.254), ethnicity , religion , occupation  and level of education  were not significantly associated with IPV. However, the correlates found to be significantly associated with IPV on bivariate analysis were:The age of the participants . Being married reduced the risk of IPV while divorced women were more likely to have experienced IPV.Marital status: IPV was significantly associated with marital status . However, on further analysis, there was no significant independent association .Pregnancy status: There was an association between pregnancy status and IPV on bivariate analysis .Type of family setting: The polygamous family setting was associated with increased risk of IPV .Type of family: Extended family setting was associated with increased risk of IPV .Physical injury: There was an increased risk of sustaining physical injury following assault from an intimate partner. This association was found to be statistically significant . Women were at an increased risk of having a miscarriage following assault from their partners.Miscarriage: Miscarriage was significantly associated with IPV .Substance use by the respondents: There was an association between the increased use of substances such as sleeping pills and IPV .Alcohol use by the partner: Alcohol consumption by the partner was significantly associated with IPV .Depression: IPV was significantly associated with depression in women . Being overweight or obese increased the risk of IPV.Body mass index: Overweight and obesity were associated with IPV .Blood pressure: IPV is significantly associated with the development of hypertension in women  of the participants agreed that a husband is justified for beating or hitting his wife for at least one of the reasons asked. Neglecting the child was the reason given by most of the participants, 105 (26.7%), to justify wife beating while cooking meals late was the reason given by the least, 40 (10.2%), participants to justify wife beating. Two hundred and thirty-four (59.5%) of the participants did not think IPV was justified for any reason. The perception of participants on IPV is summarised in Health professionals are often the earliest point of contact for survivors of violence. Family physicians, through effective case management, co-ordinated and continuing care, can alleviate some of the negative effects of partner violence on women suffering in silence. In addition, through publications of research findings, family physicians can create awareness of the burden of the problem and as such promote advocacy for women empowerment.1 It is also similar to the prevalence of 45.6% in Africa.3 In Nigeria, a similar prevalence of 46.3% was reported by Ilika and colleagues in a clinic-based study among the Igbo community in Neni, Anambra State.9 Okenwa and colleagues reported a prevalence of 29% among women of childbearing age in Lagos, South west of Nigeria.13 The lower prevalence in their study could be due to the differences in methodology and the socio-cultural characteristics of the study populations. The prevalence of IPV reported in this study could still be underestimated because of beliefs that issues concerning families and intimate relationships should not be discussed as it is seen as a \u2018private matter\u2019.14The prevalence of IPV within the previous year in this study was 42.0% which is within the range of global estimates of IPV prevalence of between 20% and 50%.The present study measured four different patterns of IPV among all the participants (393) involved in the study.15 It is fairly higher than the reports of physical violence from Eastern Nigeria by Ilika et al. in Anambra State (15.8%) and Okemgbo et al. in Imo State (20.1%).16 These differences could be due to differences in cultural characteristics of the study populations. Northern Nigeria has a distinct culture and tradition of female seclusion (\u2018Purdah\u2019), practice of polygamy, forced marriages and desire for large families. In the Igbo tribe, it is culturally unacceptable to beat a pregnant or lactating mother.14 Based on comparison on studies about the association between pregnancy and IPV across the world, many studies reported that the association remains uncertain whether, in fact, the risk of IPV initiation or escalation increases, decreases or remains the same as a result of pregnancy. The reason that was advanced was that studies that examined the risk of IPV during pregnancy did not examine the patterns of IPV around the period of pregnancy through comparisons of IPV prevalence rates in the pre-pregnancy, pregnancy and post-pregnancy periods.18 IPV against women before pregnancy was a strong risk factor for abuse during pregnancy and after delivery, and abuse during a previous period was a strong indicator of subsequent abuse.18Physical violence: In the present study, 29.0% of the 393 participants experienced physical violence from their intimate partners. The result from this study is comparable with reports of physical violence by Iliyasu et al. in Kano (27.5%), and Gyuse and Ushie in Jos (26.5%).19 Although psychological violence was found to be the most prevalent form of IPV in the present study, it is still much higher than the 23.0% reported in a study by Okenwa and colleagues among women of childbearing age in Lagos, Nigeria, in which psychological violence was also the commonest form of IPV.13 Zungu et al. admitted the difficulty in measurement of psychological IPV due to diversity in cultures.5Emotional/psychological violence: In this study, 46.6% of the 393 participants experienced emotional violence which is comparable to the prevalence of 47.5% reported by Al-Nsour in Jordan and 50.8% reported by Iliyasu et al. among female university students in northern Nigeria.20 This wide range suggests a variation in the degree to which such behaviour is normative or acceptable in different cultures.Controlling behaviour/harassment: In this study, 43.3% of the 393 participants experienced controlling behaviour from their intimate partners. A study by Adebayo et al., in Lagos, Nigeria, found a higher prevalence (71.9%) among their study participants.1 The result is also consistent with prevalence rates reported in Imo state (21.3%), Kano (22.2%) and Lagos (21.0%).22 The prevalence in this study is higher than the prevalence reported from a study in Jos (10.7%), which was conducted among an obstetric population.15Sexual violence: In this study, 21.9% of the 393 participants experienced sexual violence which is within the range of 10% and 50% reported from the WHO Multicountry study.4 This may also be due to the patriarchal nature of Nigerian ethnic groups and religions.The differences in age, religion, ethnicity and educational level were not statistically significant in the present study. This may be related to the fact that IPV cuts across age, class, race, ethnicity, religion and national boundries.14 Another respondent in a focused group discussion by Odimegwu et al. among the Tiv in Nigeria was of the opinion that \u2018if you are not yet beaten by your husband, then you do not know the joy of marriage and that means you are not yet married\u2019.21 Thus, the perception of women to justify wife beating varies according to cultural norms and personal attributes, which suggests that designing an effective intervention to eliminate violence against women would require culturally acceptable programmes.This study revealed that a high percentage of the participants (40.5%) agreed that a husband is justified for hitting or beating his wife under the conditions examined in this study. The high level of support expressed for wife beating in this study confirms that violence against women is accepted as a cultural norm. A respondent from a focused group discussion by Ilika et al. among Igbo women of Ozubulu community in Anambra State was of the view that \u2018a woman deserves beating if she talked back on her husband, refused him sex, presented a poorly cooked food, or late meal, and failed to care for the children\u2019.This study revealed a high percentage (67.9%) of the victims of IPV sustained physical injuries such as bruises, red eyes, lacerations, etc, following assault from their partner. This is an expected finding given the high prevalence of IPV found in this study.4 IPV is an established risk factor for depression and depression has also been described as a health consequence of IPV.1 Thus, IPV can be conceptualised as a risk factor, correlate or outcome of substance use and depression. IPV being a significant cause of psychiatric illness in women, its exclusion in this study would tend to underestimate the prevalence that was reported. However, women with known psychiatric illness were excluded because their concentration, memory and judgement could be impaired, thus information obtained cannot be relied upon. Its exclusion is a limitation for this study.This study has found a significant positive association between IPV, depression and substance use among the victims of abuse. This finding is consistent with reports from similar studies within and outside Nigeria.This study found that women are at an increased risk of having a miscarriage following assault from their partners . This finding is consistent with the reports from the studies that showed that women with a history of physical or sexual abuse are also at an increased risk for unintended pregnancies, sexually transmitted diseases and miscarriages.1,The high prevalence of IPV among women of reproductive age in this study shows that it is an important problem that women would rather not talk about or have accepted as a norm. It is associated with poor physical and mental health of women who are victims.This study provides insight for policy makers, physicians and researchers who are attempting to tackle the global issue of IPV.It is therefore recommended that physicians routinely screen for IPV especially in patients with depressive symptoms, non-specific complaints, miscarriage and physical injuries on the face, trunk and upper limbs. Screening will be a safe and cost-effective means for identifying women experiencing IPV, leading to appropriate interventions that will decrease further exposure to IPV and its adverse health consequences."]}
{"representative": "Intimate partner violence (IPV) is a significant public health issue among married rural-to-urban migrant workers, the largest group of internal migrants in China. This study aims to explore the prevalence, patterns and associated factors of intimate partner violence against married rural-to-urban migrant workers in eastern China.A cross-sectional study was conducted in Zhejiang province in China between July 2015 and April 2016, and a total of 1,744 married rural-to-urban migrant workers ultimately took part in the study. Conflict Tactics Scales and several short demographic questions were applied. Data were principally analyzed with logistic regression.The majority of married rural-to-urban migrant workers were middle-aged couples with a low education level and a relatively long-term duration of migration in fixed migrant cities. Nearly 45% of married rural-to-urban migrant workers were experienced at least one incident of intimate partner violence during the past 12\u00a0months. The joint occurrence of multiple forms of violence is the most commonly reported features of intimate partner violence, especially three overlapping patterns of intimate partner violence. Some individual (education and age), relationship  and social (duration of migration and number of migratory cities) factors of the respondents, were negatively or positively associated with intimate partner violence against married rural-to-urban migrant workers.The results indicated that one out of two married rural-to-urban migrant workers experienced at least one incident of intimate partner violence during the past 12\u00a0months in China. Accordingly, there is an obvious demand of intervention and treatment activities to prevent and reduce the occurrence of intimate partner violence among the millions of migrant workers in China.The online version of this article (doi:10.1186/s12889-016-3896-x) contains supplementary material, which is available to authorized users. Intimate partner violence (IPV) is a serious and widespread problem worldwide. It is a domestic violence by a spouse or partner in an intimate relationship against the other spouse or partner , and theIPV has been shown to be the most common type of violence against married couples, especially among women groups. For example, a study, based on 48 population-based surveys from developing and developed countries and conducted by World Health Organization (WHO) in 2002, found that 13\u201361% of women in countries across the world reported having experienced IPV from their partners . AnotherMeanwhile, IPV affects physical health and mental health of IPV survivors and their families adversely through direct pathways, such as injury, humiliation and isolation, and indirect pathways, such as family function, attachment, marital satisfaction and other factors \u201313. A hiThese research not only have significantly advanced current knowledge concerning IPV among different groups, but also have motivated new important research questions. For instance, rural-to-urban migrant workers in china are now experiencing the largest mass migration of people from the countryside to the city in history . MigratiThe present study, based on those existing studies, aims to further explore IPV among married rural-to-urban migrant workers with making the following three specific efforts.First, we have chosen married rural-to-urban migrant workers as our subjects. In China, rural-to-urban migrant workers are a special group formed by Chinese peasants in the process of social transformation during the course of urbanization. They refer to farmers who move from rural to urban areas within China in pursuit of employment and better living standards, without no permanent urban residency (\u201chukou\u201d). According to the National Bureau of Statistics, it was estimated that there were 277 million rural-to-urban migrant workers in 2015, accounting for about 20% of the total population. Among them, an estimated 203 million were married , 21, 22.Second, we focus on the prevalence and pattern of IPV among married rural-to-urban migrant workers. In China, the issue of IPV has received limited attention until the Fourth World Conference on Women (1995) was hosted in Beijing. In the past two decades, the relevant studies on IPV in China have mainly been conducted on theoretical mechanism of IPV. The first empirical and wide-scale study on IPV in china was carried out in 2000. It was found that 34.7% of 3,543 investigated women admitted that they had experienced physical, psychological or sexual violence . The folThird, according to the ecological model theory of violence, the causes of IPV are diverse and there is no single factor that explains further why some individuals are violent. Rather, violence is a result of individual, relationship and societal factors . TherefoThe aims of the present paper were to (1) examine prevalence and pattern of IPV among married rural-to-urban migrant workers in Eastern China and (2) identify the risk and protective factors for IPV at three levels: individual, relationship and societal level.In this study, rural-to-urban migrant workers were defined as those who were 18\u00a0years of age or older, possess a legal rural hukou , and have been granted the legal right to work temporarily in urban and prosperous coastal regions for at least six months . MigrantA cross-sectional study was conducted in Zhejiang province in China between July 2015 and April 2016, and a total of 1,744 married rural-to-urban migrant workers ultimately took part in the study. The final eligible participants were identified by the multistage probability sampling method as follows.In stage 1, four cities, Hangzhou, Ningbo, Wenzhou and Jinghua, were selected from Zhejiang Province in China, respectively. We chose these four cities of Zhejiang Province as our study cites since Zhejiang was one of the most economically developed provinces in China\u2019s four economical zones with a migrant population of estimated 14 million in 2015, accounting for around one-thirds of the province\u2019s population. Meanwhile, more than two-thirds of rural-to-urban migrant workers in this area are currently in Hangzhou, Ningbo, Wenzhou and Jinghua. In stage 2, three districts in each of the four study cities were randomly selected, and these districts represented the inner-city, suburban and urban fringe zone. In stage 3, two residential sub-districts with a high density of rural\u2013urban migrants in each of the three studies districts were randomly selected. In stage 4, a quota-sampling procedure based on six occupational clusters was applied to ensure that the sample was representative of the migrant worker population in Zhejiang. According to the figures released by the National Bureau of Statistics of China in 2015, in Zhejiang, the proportions of migrant workers in six occupational clusters, manufacturing, wholesale and retail, construction, domestic service, transportation, and hotels and restaurants, were approximately 45, 13, 11, 9, 6, and 4%, respectively [Hence, 1,864 married rural-to-urban migrant workers were eligible for the study and consent with the study procedures, and then1,744 made valid replies, yielding a response rate of 93.56%. Details of socio-demographic characteristics of the sample are displayed in Table\u00a0The present study consisted of the following two-steps procedure. First, in the pilot study, the pre-test was conducted with a convenience sample of 50 married rural-to-urban migrant workers from the target population to evaluate clarity, comprehensiveness, and acceptability of questionnaires. Some amendments were made prior to the initial delivering. Secondly, in the formal study, after fully understanding the purpose and the procedure of the study, the eligible participants signed the informed consent. With their agreement, one envelope with the questionnaire and instructions was handed to every participant. The instructions told them how to fill in the questionnaire. Participants filled out the 20-minute questionnaires in quiet and comfortable reading rooms in factory (one to six participants at one time), then placed the completed questionnaire inside an envelope and gave it back to the researchers. Third, at the end of the survey, each of participants received a leaflet detailing local support services or network counseling service for domestic violence, sexual abuse and other mental health problems. Fourth, upon completion, everyone was given a towel, a tooth brush and a tooth paste as a token of appreciation. The questionnaires were administered by trained researchers, including faculty members and postgraduate students from Wenzhou Medical University, who had been provided systematic training before formal study. The questionnaires were anonymous and all participants took part in the study voluntarily.This study was done in compliance with the Helsinki Declaration, and was reviewed and approved by the Ethics Committee of Wenzhou Medical University.A socio-demographic questionnaire consisted of three parts. The first part is the individual-level information including age, gender, education, region of origin (north vs. south), monthly income and other basic demographic information. The second part is the relationship-level information. In this study, relationship-level information focuses on marital information including marital status, lifestyle with your spouse (living together vs. living in separate places), marital satisfaction, premarital sex (yes vs. no) and extramarital affairs (yes vs. no). The third part is societal-level information. In this study, societal-level information focuses on migratory information including duration of migration and number of migratory cities.Intimate partner violence was measured by the Chinese version of short form of the revised Conflict Tactics Scales CTS2) , 30 . Firstly, psychological IPV was assessed by psychological aggression subscale of the Chinese version of short form CTS2. Specifically, the self-reported frequency of psychological abuse from the other spouse in the past year was recorded. Examples of psychological IPV include: insulted, swore, shouted, yelled by spouse and made me feel bad about myself; destroyed belongings or threatens to hit. The psychological IPV subscale consists of four items with high degree of internal consistency reliability among the Chinese participants (Cronbach\u2019s \u03b1\u2009=\u20090.72) .Secondly, physical IPV was assessed by physical assault subscale of the Chinese version of short form CTS2. Specifically, the self-reported frequency of physical assault from the other spouse in the past year was recorded. Examples of physical IPV include: pushed, shoved, slapped, punched, kicked and beatin of the spouse. The physical assault subscale consists of four items with good degree of internal consistency reliability among the Chinese participants (Cronbach\u2019s \u03b1\u2009=\u20090.88) .Thirdly, sexual IPV was assessed by sexual coercion subscale of the Chinese version of short form CTS2. Specifically, the self-reported frequency of intimate partner\u2019s sexual coercion from the other spouse in the past year was recorded. Examples of sexual IPV include: physically forced to have sex; did not want to have sex or forced to have sex without a condom. The sexual coercion subscale consists of four items with good degree of internal consistency reliability among the Chinese participants (Cronbach\u2019s \u03b1\u2009=\u20090.93) .P-values are 2-tailed with statistical significance set at 0.05.First of all, socio-demographic characteristics of the sample were described by the number and the percentage of each category for categorical variables. Secondly, we calculated prevalence estimates, frequency and overlap in different forms of IPV among married migrant workers in the past 12\u00a0months. Thirdly, multivariate binary logistic regression analysis was used to determine the risk factors for IPV of married migrant workers, and crude odds ratios and adjusted odds ratios (OR) and 95% confidence intervals (CIs) for OR were calculated. In logistic regression modeling, overall IPV, psychological IPV, physical IPV, and sexual IPV were considered as the dependent variables respectively, and the demographic characteristics of the married migrant workers including individual level determinants , marital determinants  and migratory determinants (duration of migration and number of migratory cities) were considered as the independent variables. All statistical analyses were performed with the use of SPSS statistics package (version 18.0) and all reported Of the 1,744 participants, 875 (50.1%) were male and 871 (49.9%) were female. The participants\u2019 age ranged from 19 to 61\u00a0years old (37.74\u2009\u00b1\u20099.01\u00a0years). 45.9% of migrant workers could be classified as \u201csecond-generation\u201d migrants. Their duration of marriage ranged from 1 to 45\u00a0years (13.15\u2009\u00b1\u20099.70\u00a0years). Over a half of the married migrant workers only had a junior high school education or below, and the average time in schooling was 9.29\u2009\u00b1\u20092.62\u00a0years. Regarding monthly income, the average monthly income of the participants was 3883 RMB (approximately US$596). Only 10.3% of the participants earned less than 2500 Yuan , nearly half (48.5%) earned 2501\u20133500 Yuan (RMB), and 41.2% earned more than 3500 Yuan (RMB). The average duration of migration was 12.66\u2009\u00b1\u20096.89\u00a0years, and almost 60.5% of the participants reported having migrated to only one or two cities, while 8.1% reported having been migrated to more than five cities. In terms of marital status, 1633 participants (93.6%) were first married and 111 were remarried (6.4%). The majority of participants were satisfied with their marriage (79.4%) and living with their spouse together every day (78.2%). It is worth mentioning that nearly 32.8% of the participants reported having sexual intercourse before marriage and 7.9% reported having an affair after marriage. The general demographic, migration and marital characteristics of the married migrant workers are summarized in Table\u00a0Table\u00a0The different forms of IPV and their overlapping are shown in the Venn diagrams in Fig.\u00a0In the regression model of overall IPV, as shown in Table\u00a0In the regression model of psychological IPV, as shown in Table\u00a0In the regression model of physical IPV, as shown in Table\u00a0In the regression model of sexual IPV, as shown in Table\u00a0This study estimated the prevalence, frequency and patterns of different types of IPV in a large sample of typical Chinese married rural-to-urban migrant workers, and identified the risk and protective factors for IPV at three levels: individual, relationship and societal level.The first finding of the study is that as high as 45% of married rural-to-urban migrant workers experienced at least one act of physical, psychological or sexual IPV during the past 12\u00a0months. The incidence rate of IPV in this study is within the estimated range of IPV but is much higher than the findings of other Asian studies, including studies from other parts of China \u201333. For The second important finding of the study is that among these domestic violence victims, over a half of them experienced multiple forms of violence from their intimate partners, especially three overlapping patterns of IPV. These findings are in line with most of previous studies , 35, 36.The third important finding of the study is that some individual, relationship and societal factors are significantly associated with an increased or decreased likelihood of intimate partner violence against married rural-to-urban migrant workers.At the individual level, the high level of education for the subjects was identified as a protective factor of IPV, especially physical IPV. Meanwhile, low level of education is the most consistent factor associated with both the perpetration and experiencing of overall IPV and physical violence across studies \u201340. For Furthermore, compared to the first-generation rural-to-urban migrant workers, the second-generation rural-to-urban migrant workers are less likely to report current experience of overall IPV, especially psychological violence. This finding is inconsistent with results of previous studies which always identified young age to be a risk factor for intimate partner violence , 41, 42.At the relationship level, low level of marital satisfaction was identified as a significant risk factor of IPV, especially psychological and physical IPV. In this study, respondents who reported dissatisfaction with their marriages were more than five times as likely to experience IPV as respondents who expressed satisfaction. Our findings are in line with previous research that individuals dissatisfied with their marriage are more likely to be involved in psychologically or physically abusive relationships than those individuals satisfied with their marriage , 44. ThiIn particular, premarital sex and extramarital affairs were two of the most consistent markers of IPV. On the one hand, premarital sex was considered a moral issue which was still taboo in traditional Chinese culture and typically unacceptable by the old generation. Hence, premarital sex usually enable an individual to suffer from poor self-image, low self esteem, feelings of embarrassment, humiliation and other risk factors contributing to violence in the family. On the other hand, extramarital affairs also are a strong risk factor of IPV. This is consistent with findings from other studies elsewhere \u201348. InfiAt the societal level, duration of migration acted as a protective factor for IPV, especially physical IPV and sexual IPV. Specifically, long-term migrant workers are less likely to have experience of physical IPV and sexual IPV than short-term ones. It is possibly explained that migration from rural to urban areas is the process of urbanization which create great opportunities for migrant workers to get good education and improve their living standards. Furthermore, their traditional social norms supportive of violence may be transferred through urbanization processes. On the contrary, the increasing number of migratory cities appears to be a risk factor for being a victim of physical IPV. In this study, compared to respondents migrating to one or two cities, those migrating above five cities were about twice more likely to report physical IPV. It is clear that frequent moves could increase the likelihood of unstable living situations, and several studies have demonstrated that housing instability was a significant predictor of domestic violence , 50. As We should acknowledge some limitations in our study. First and foremost, our study was based on cross-sectional design, which is not possible to get a valid cause-and-effect relation between intimate partner violence and the associated factors. To clarify the causality, we need longitudinal data or panel data for further research. Secondly, we only examine prevalence of intimate partner violence in past 12\u00a0months without including the prevalence of lifetime IPV, which may limit the generalizability of the findings to the target population. Third, information on experiences with IPV is very sensitive and private. In our study, data were self-reported in nature and respondents may be too embarrassed to reveal private details, which may be subject to reporting bias. Future studies should consider triangulating self-reports with clinical records, and health and social services records. Fourth, some relevant potential factors that are important to the IPV research were not included, such as participant\u2019s drug use, alcohol, smoking, poverty, having children, being pregnant and different types of marriage. The investigation of these factors could be key directions for future research. Additionally, the use of the Conflict Tactics Scale to measure the psychological IPV, physical IPV and sexual IPV also limits the findings. Although the CTS scale has been widely used in a large number of studies on IPV, there have been several criticisms regarding this scale . For insThe present study has several strengths. First, the sample size was large enough to allow more reliable results with greater precision and power. In addition, interviewers and supervisors received systematic training and have past experiences of data collection; hence it was found a high response and prevalence rate of the study. Second, to our knowledge, this study is the first estimation of the prevalence, frequency and patterns of different types of IPV in a large sample of typical Chinese married rural-to-urban migrant workers. Thirdly, our study is one of the first studies to identify the risk and protective factors for IPV against migrant workers based on the ecological model . It might offer a framework for understanding the associated factors that influence IPV, and can therefore provide key points for prevention and intervention of IPV among married rural-to-urban migrant workers.In conclusion, this study provides empirical evidence for the prevalence of different types of IPV against married migrant workers. Nearly half of married migrant workers experienced at least one incident of IPV during the past 12\u00a0months. Moreover psychological IPV was the most prevalent type of violence married rural-to-urban migrant workers experienced. Alarmingly, the joint occurrence of multiple forms of violence is the most commonly reported features of IPV, especially three overlapping patterns of IPV. Some individual (education and age), relationship  and social (duration of migration and number of migratory cities) factors of the respondents, were negatively or positively associated with IPV in the study area.Given the massive number of married migrants in China, the domestic violence against them should receive urgent attention at all levels of societal organization including policymakers, stakeholders, professionals and other concerned body. Furthermore, despite limited resources, the screening, treatment, and intervention programs targeting IPV and its risk factors should be developed to identify, prevent, and reduce the occurrence and reoccurrence of IPV among the millions of migrant workers in China. Moreover, extensive and longitudinal research is needed to validate the current findings", "texts": ["Intimate partner violence (IPV) is a significant public health issue among married rural-to-urban migrant workers, the largest group of internal migrants in China. This study aims to explore the prevalence, patterns and associated factors of intimate partner violence against married rural-to-urban migrant workers in eastern China.A cross-sectional study was conducted in Zhejiang province in China between July 2015 and April 2016, and a total of 1,744 married rural-to-urban migrant workers ultimately took part in the study. Conflict Tactics Scales and several short demographic questions were applied. Data were principally analyzed with logistic regression.The majority of married rural-to-urban migrant workers were middle-aged couples with a low education level and a relatively long-term duration of migration in fixed migrant cities. Nearly 45% of married rural-to-urban migrant workers were experienced at least one incident of intimate partner violence during the past 12\u00a0months. The joint occurrence of multiple forms of violence is the most commonly reported features of intimate partner violence, especially three overlapping patterns of intimate partner violence. Some individual (education and age), relationship  and social (duration of migration and number of migratory cities) factors of the respondents, were negatively or positively associated with intimate partner violence against married rural-to-urban migrant workers.The results indicated that one out of two married rural-to-urban migrant workers experienced at least one incident of intimate partner violence during the past 12\u00a0months in China. Accordingly, there is an obvious demand of intervention and treatment activities to prevent and reduce the occurrence of intimate partner violence among the millions of migrant workers in China.The online version of this article (doi:10.1186/s12889-016-3896-x) contains supplementary material, which is available to authorized users. Intimate partner violence (IPV) is a serious and widespread problem worldwide. It is a domestic violence by a spouse or partner in an intimate relationship against the other spouse or partner , and theIPV has been shown to be the most common type of violence against married couples, especially among women groups. For example, a study, based on 48 population-based surveys from developing and developed countries and conducted by World Health Organization (WHO) in 2002, found that 13\u201361% of women in countries across the world reported having experienced IPV from their partners . AnotherMeanwhile, IPV affects physical health and mental health of IPV survivors and their families adversely through direct pathways, such as injury, humiliation and isolation, and indirect pathways, such as family function, attachment, marital satisfaction and other factors \u201313. A hiThese research not only have significantly advanced current knowledge concerning IPV among different groups, but also have motivated new important research questions. For instance, rural-to-urban migrant workers in china are now experiencing the largest mass migration of people from the countryside to the city in history . MigratiThe present study, based on those existing studies, aims to further explore IPV among married rural-to-urban migrant workers with making the following three specific efforts.First, we have chosen married rural-to-urban migrant workers as our subjects. In China, rural-to-urban migrant workers are a special group formed by Chinese peasants in the process of social transformation during the course of urbanization. They refer to farmers who move from rural to urban areas within China in pursuit of employment and better living standards, without no permanent urban residency (\u201chukou\u201d). According to the National Bureau of Statistics, it was estimated that there were 277 million rural-to-urban migrant workers in 2015, accounting for about 20% of the total population. Among them, an estimated 203 million were married , 21, 22.Second, we focus on the prevalence and pattern of IPV among married rural-to-urban migrant workers. In China, the issue of IPV has received limited attention until the Fourth World Conference on Women (1995) was hosted in Beijing. In the past two decades, the relevant studies on IPV in China have mainly been conducted on theoretical mechanism of IPV. The first empirical and wide-scale study on IPV in china was carried out in 2000. It was found that 34.7% of 3,543 investigated women admitted that they had experienced physical, psychological or sexual violence . The folThird, according to the ecological model theory of violence, the causes of IPV are diverse and there is no single factor that explains further why some individuals are violent. Rather, violence is a result of individual, relationship and societal factors . TherefoThe aims of the present paper were to (1) examine prevalence and pattern of IPV among married rural-to-urban migrant workers in Eastern China and (2) identify the risk and protective factors for IPV at three levels: individual, relationship and societal level.In this study, rural-to-urban migrant workers were defined as those who were 18\u00a0years of age or older, possess a legal rural hukou , and have been granted the legal right to work temporarily in urban and prosperous coastal regions for at least six months . MigrantA cross-sectional study was conducted in Zhejiang province in China between July 2015 and April 2016, and a total of 1,744 married rural-to-urban migrant workers ultimately took part in the study. The final eligible participants were identified by the multistage probability sampling method as follows.In stage 1, four cities, Hangzhou, Ningbo, Wenzhou and Jinghua, were selected from Zhejiang Province in China, respectively. We chose these four cities of Zhejiang Province as our study cites since Zhejiang was one of the most economically developed provinces in China\u2019s four economical zones with a migrant population of estimated 14 million in 2015, accounting for around one-thirds of the province\u2019s population. Meanwhile, more than two-thirds of rural-to-urban migrant workers in this area are currently in Hangzhou, Ningbo, Wenzhou and Jinghua. In stage 2, three districts in each of the four study cities were randomly selected, and these districts represented the inner-city, suburban and urban fringe zone. In stage 3, two residential sub-districts with a high density of rural\u2013urban migrants in each of the three studies districts were randomly selected. In stage 4, a quota-sampling procedure based on six occupational clusters was applied to ensure that the sample was representative of the migrant worker population in Zhejiang. According to the figures released by the National Bureau of Statistics of China in 2015, in Zhejiang, the proportions of migrant workers in six occupational clusters, manufacturing, wholesale and retail, construction, domestic service, transportation, and hotels and restaurants, were approximately 45, 13, 11, 9, 6, and 4%, respectively [Hence, 1,864 married rural-to-urban migrant workers were eligible for the study and consent with the study procedures, and then1,744 made valid replies, yielding a response rate of 93.56%. Details of socio-demographic characteristics of the sample are displayed in Table\u00a0The present study consisted of the following two-steps procedure. First, in the pilot study, the pre-test was conducted with a convenience sample of 50 married rural-to-urban migrant workers from the target population to evaluate clarity, comprehensiveness, and acceptability of questionnaires. Some amendments were made prior to the initial delivering. Secondly, in the formal study, after fully understanding the purpose and the procedure of the study, the eligible participants signed the informed consent. With their agreement, one envelope with the questionnaire and instructions was handed to every participant. The instructions told them how to fill in the questionnaire. Participants filled out the 20-minute questionnaires in quiet and comfortable reading rooms in factory (one to six participants at one time), then placed the completed questionnaire inside an envelope and gave it back to the researchers. Third, at the end of the survey, each of participants received a leaflet detailing local support services or network counseling service for domestic violence, sexual abuse and other mental health problems. Fourth, upon completion, everyone was given a towel, a tooth brush and a tooth paste as a token of appreciation. The questionnaires were administered by trained researchers, including faculty members and postgraduate students from Wenzhou Medical University, who had been provided systematic training before formal study. The questionnaires were anonymous and all participants took part in the study voluntarily.This study was done in compliance with the Helsinki Declaration, and was reviewed and approved by the Ethics Committee of Wenzhou Medical University.A socio-demographic questionnaire consisted of three parts. The first part is the individual-level information including age, gender, education, region of origin (north vs. south), monthly income and other basic demographic information. The second part is the relationship-level information. In this study, relationship-level information focuses on marital information including marital status, lifestyle with your spouse (living together vs. living in separate places), marital satisfaction, premarital sex (yes vs. no) and extramarital affairs (yes vs. no). The third part is societal-level information. In this study, societal-level information focuses on migratory information including duration of migration and number of migratory cities.Intimate partner violence was measured by the Chinese version of short form of the revised Conflict Tactics Scales CTS2) , 30 . Firstly, psychological IPV was assessed by psychological aggression subscale of the Chinese version of short form CTS2. Specifically, the self-reported frequency of psychological abuse from the other spouse in the past year was recorded. Examples of psychological IPV include: insulted, swore, shouted, yelled by spouse and made me feel bad about myself; destroyed belongings or threatens to hit. The psychological IPV subscale consists of four items with high degree of internal consistency reliability among the Chinese participants (Cronbach\u2019s \u03b1\u2009=\u20090.72) .Secondly, physical IPV was assessed by physical assault subscale of the Chinese version of short form CTS2. Specifically, the self-reported frequency of physical assault from the other spouse in the past year was recorded. Examples of physical IPV include: pushed, shoved, slapped, punched, kicked and beatin of the spouse. The physical assault subscale consists of four items with good degree of internal consistency reliability among the Chinese participants (Cronbach\u2019s \u03b1\u2009=\u20090.88) .Thirdly, sexual IPV was assessed by sexual coercion subscale of the Chinese version of short form CTS2. Specifically, the self-reported frequency of intimate partner\u2019s sexual coercion from the other spouse in the past year was recorded. Examples of sexual IPV include: physically forced to have sex; did not want to have sex or forced to have sex without a condom. The sexual coercion subscale consists of four items with good degree of internal consistency reliability among the Chinese participants (Cronbach\u2019s \u03b1\u2009=\u20090.93) .P-values are 2-tailed with statistical significance set at 0.05.First of all, socio-demographic characteristics of the sample were described by the number and the percentage of each category for categorical variables. Secondly, we calculated prevalence estimates, frequency and overlap in different forms of IPV among married migrant workers in the past 12\u00a0months. Thirdly, multivariate binary logistic regression analysis was used to determine the risk factors for IPV of married migrant workers, and crude odds ratios and adjusted odds ratios (OR) and 95% confidence intervals (CIs) for OR were calculated. In logistic regression modeling, overall IPV, psychological IPV, physical IPV, and sexual IPV were considered as the dependent variables respectively, and the demographic characteristics of the married migrant workers including individual level determinants , marital determinants  and migratory determinants (duration of migration and number of migratory cities) were considered as the independent variables. All statistical analyses were performed with the use of SPSS statistics package (version 18.0) and all reported Of the 1,744 participants, 875 (50.1%) were male and 871 (49.9%) were female. The participants\u2019 age ranged from 19 to 61\u00a0years old (37.74\u2009\u00b1\u20099.01\u00a0years). 45.9% of migrant workers could be classified as \u201csecond-generation\u201d migrants. Their duration of marriage ranged from 1 to 45\u00a0years (13.15\u2009\u00b1\u20099.70\u00a0years). Over a half of the married migrant workers only had a junior high school education or below, and the average time in schooling was 9.29\u2009\u00b1\u20092.62\u00a0years. Regarding monthly income, the average monthly income of the participants was 3883 RMB (approximately US$596). Only 10.3% of the participants earned less than 2500 Yuan , nearly half (48.5%) earned 2501\u20133500 Yuan (RMB), and 41.2% earned more than 3500 Yuan (RMB). The average duration of migration was 12.66\u2009\u00b1\u20096.89\u00a0years, and almost 60.5% of the participants reported having migrated to only one or two cities, while 8.1% reported having been migrated to more than five cities. In terms of marital status, 1633 participants (93.6%) were first married and 111 were remarried (6.4%). The majority of participants were satisfied with their marriage (79.4%) and living with their spouse together every day (78.2%). It is worth mentioning that nearly 32.8% of the participants reported having sexual intercourse before marriage and 7.9% reported having an affair after marriage. The general demographic, migration and marital characteristics of the married migrant workers are summarized in Table\u00a0Table\u00a0The different forms of IPV and their overlapping are shown in the Venn diagrams in Fig.\u00a0In the regression model of overall IPV, as shown in Table\u00a0In the regression model of psychological IPV, as shown in Table\u00a0In the regression model of physical IPV, as shown in Table\u00a0In the regression model of sexual IPV, as shown in Table\u00a0This study estimated the prevalence, frequency and patterns of different types of IPV in a large sample of typical Chinese married rural-to-urban migrant workers, and identified the risk and protective factors for IPV at three levels: individual, relationship and societal level.The first finding of the study is that as high as 45% of married rural-to-urban migrant workers experienced at least one act of physical, psychological or sexual IPV during the past 12\u00a0months. The incidence rate of IPV in this study is within the estimated range of IPV but is much higher than the findings of other Asian studies, including studies from other parts of China \u201333. For The second important finding of the study is that among these domestic violence victims, over a half of them experienced multiple forms of violence from their intimate partners, especially three overlapping patterns of IPV. These findings are in line with most of previous studies , 35, 36.The third important finding of the study is that some individual, relationship and societal factors are significantly associated with an increased or decreased likelihood of intimate partner violence against married rural-to-urban migrant workers.At the individual level, the high level of education for the subjects was identified as a protective factor of IPV, especially physical IPV. Meanwhile, low level of education is the most consistent factor associated with both the perpetration and experiencing of overall IPV and physical violence across studies \u201340. For Furthermore, compared to the first-generation rural-to-urban migrant workers, the second-generation rural-to-urban migrant workers are less likely to report current experience of overall IPV, especially psychological violence. This finding is inconsistent with results of previous studies which always identified young age to be a risk factor for intimate partner violence , 41, 42.At the relationship level, low level of marital satisfaction was identified as a significant risk factor of IPV, especially psychological and physical IPV. In this study, respondents who reported dissatisfaction with their marriages were more than five times as likely to experience IPV as respondents who expressed satisfaction. Our findings are in line with previous research that individuals dissatisfied with their marriage are more likely to be involved in psychologically or physically abusive relationships than those individuals satisfied with their marriage , 44. ThiIn particular, premarital sex and extramarital affairs were two of the most consistent markers of IPV. On the one hand, premarital sex was considered a moral issue which was still taboo in traditional Chinese culture and typically unacceptable by the old generation. Hence, premarital sex usually enable an individual to suffer from poor self-image, low self esteem, feelings of embarrassment, humiliation and other risk factors contributing to violence in the family. On the other hand, extramarital affairs also are a strong risk factor of IPV. This is consistent with findings from other studies elsewhere \u201348. InfiAt the societal level, duration of migration acted as a protective factor for IPV, especially physical IPV and sexual IPV. Specifically, long-term migrant workers are less likely to have experience of physical IPV and sexual IPV than short-term ones. It is possibly explained that migration from rural to urban areas is the process of urbanization which create great opportunities for migrant workers to get good education and improve their living standards. Furthermore, their traditional social norms supportive of violence may be transferred through urbanization processes. On the contrary, the increasing number of migratory cities appears to be a risk factor for being a victim of physical IPV. In this study, compared to respondents migrating to one or two cities, those migrating above five cities were about twice more likely to report physical IPV. It is clear that frequent moves could increase the likelihood of unstable living situations, and several studies have demonstrated that housing instability was a significant predictor of domestic violence , 50. As We should acknowledge some limitations in our study. First and foremost, our study was based on cross-sectional design, which is not possible to get a valid cause-and-effect relation between intimate partner violence and the associated factors. To clarify the causality, we need longitudinal data or panel data for further research. Secondly, we only examine prevalence of intimate partner violence in past 12\u00a0months without including the prevalence of lifetime IPV, which may limit the generalizability of the findings to the target population. Third, information on experiences with IPV is very sensitive and private. In our study, data were self-reported in nature and respondents may be too embarrassed to reveal private details, which may be subject to reporting bias. Future studies should consider triangulating self-reports with clinical records, and health and social services records. Fourth, some relevant potential factors that are important to the IPV research were not included, such as participant\u2019s drug use, alcohol, smoking, poverty, having children, being pregnant and different types of marriage. The investigation of these factors could be key directions for future research. Additionally, the use of the Conflict Tactics Scale to measure the psychological IPV, physical IPV and sexual IPV also limits the findings. Although the CTS scale has been widely used in a large number of studies on IPV, there have been several criticisms regarding this scale . For insThe present study has several strengths. First, the sample size was large enough to allow more reliable results with greater precision and power. In addition, interviewers and supervisors received systematic training and have past experiences of data collection; hence it was found a high response and prevalence rate of the study. Second, to our knowledge, this study is the first estimation of the prevalence, frequency and patterns of different types of IPV in a large sample of typical Chinese married rural-to-urban migrant workers. Thirdly, our study is one of the first studies to identify the risk and protective factors for IPV against migrant workers based on the ecological model . It might offer a framework for understanding the associated factors that influence IPV, and can therefore provide key points for prevention and intervention of IPV among married rural-to-urban migrant workers.In conclusion, this study provides empirical evidence for the prevalence of different types of IPV against married migrant workers. Nearly half of married migrant workers experienced at least one incident of IPV during the past 12\u00a0months. Moreover psychological IPV was the most prevalent type of violence married rural-to-urban migrant workers experienced. Alarmingly, the joint occurrence of multiple forms of violence is the most commonly reported features of IPV, especially three overlapping patterns of IPV. Some individual (education and age), relationship  and social (duration of migration and number of migratory cities) factors of the respondents, were negatively or positively associated with IPV in the study area.Given the massive number of married migrants in China, the domestic violence against them should receive urgent attention at all levels of societal organization including policymakers, stakeholders, professionals and other concerned body. Furthermore, despite limited resources, the screening, treatment, and intervention programs targeting IPV and its risk factors should be developed to identify, prevent, and reduce the occurrence and reoccurrence of IPV among the millions of migrant workers in China. Moreover, extensive and longitudinal research is needed to validate the current findings"]}
{"representative": "Intimate partner violence (IPV) around the time of pregnancy is a serious public health concern and is known to have an adverse effect on perinatal mental health. In order to craft appropriate and effective interventions, it is important to understand how the association between IPV and postpartum depression (PPD) may differ as a function of the type and timing of IPV victimization. Here we evaluate the influence of physical, sexual and psychological IPV before, during and after pregnancy on PPD.Cross-sectional survey data was collected between October 2015 and January 2016 in the Chandpur District of Bangladesh from 426 new mothers, aged 15\u201349 years, who were in the first six months postpartum. Multivariate logistic regression models were used to estimate the association between IPV and PPD, adjusted for socio-demographic, reproductive and psychosocial confounding factors.Approximately 35.2% of women experienced PPD within the first six months following childbirth. Controlling for confounders, the odds of PPD was significantly greater among women who reported exposure to physical , sexual  or psychological  IPV during pregnancy as opposed to those who did not. However, both before and after pregnancy, only physical IPV evidences a direct effect on PPD. Results highlight the mental health consequences of IPV for women of Bangladesh, as well as the influence of timing and type of IPV on PPD outcomes.The findings confirm that exposure to IPV significantly increases the odds of PPD. The association is particularly strong for physical IPV during all periods and psychological IPV during pregnancy. Results reinforce the need to conduct routine screening during pregnancy to identify women with a history of IPV who may at risk for PPD and to offer them necessary support. Culturally, pregnancy is often viewed as a time of happiness and expectancy in women\u2019s lives, with the welcoming of the next generation and growing anticipation of the joys a new child will bring to the family. At the same time, pregnancy can also be a stressful and anxiety-provoking life event , and manPPD has been recognized as a significant global public health concern due to its profound health consequences for both mothers and their families , 11. PPDIPV includes acts of physical, sexual and psychological coercion along with controlling behaviors against women by a current or former intimate partner , 31. OneAlthough our understanding regarding the links between IPV and PPD is progressing, notable gaps remain. Until recently the majority of research has focussed primarily on physical IPV , 48, andWhilst the literature on IPV in Southeast Asia is growing, it still remains limited and there are few scholarships examining the association between IPV and PPD for women of Bangladesh. To help build this important knowledge base, we assess how the association between IPV and PPD changes as a function of the type and timing of IPV in a population-based sample of new mothers in Bangladesh. The aim of this study is to examine whether:1) recent exposure (occurred after childbirth) to physical, psychological and sexual IPV is associated with PPD in the first six months after childbirth; and 2) prior exposure (occurred before and during pregnancy) to physical, psychological and sexual IPV is also associated with PPD. Understanding the association between PPD outcomes and exposure to different forms of IPV during different periods has clinical implications regarding early detection and targeted preventative measures around the time of pregnancy to support at-risk women.A cross-sectional survey was conducted from October 2015 to January 2016 in two sub-districts of the Chandpur district of Bangladesh. New mothers who visited vaccination centers to receive their baby\u2019s vaccinations were the target population. Married women between 15\u201349 years of age currently living with their husbands for the last two years, and who had at least one child aged six months or younger were eligible for the study. These criteria were used to determine the women\u2019s experience of IPV from their current husband. A multistage random sampling method was adopted to identify vaccination centers from which to draw 426 estimated subjects. Interviewers approached 453 postpartum mothers to reach the desired sample size, yielding a response rate of 94%.The data collection procedure has been described in detail previously in , 51. FacParticipation was entirely voluntary and confidential and did not affect receiving health care in any way. Women who reported an experience of IPV were offered primary counselling services and referrals to local social and psychological services. Women who scored \u226510 on the EPDS were referred to the nearby district hospital for adequate follow-up . The intEthical approval was received for scientific and ethical integrity from the National research ethics committee of Bangladesh Medical Research Council (BMRC/NREC/2013-2016/305) and Griffith University Human Research Ethics Committee (CCJ/41/14/HREC) before conducting the study. The study was also conducted following the WHO guidelines on ethical issues for violence research . InterviThe main outcome of the present study was postpartum depression assessed by using the Bangla version of the Edinburgh Postpartum Depression Scale (EPDS) . The EPDEach participant was asked if she had experienced any of these symptoms during pregnancy or before, referred to herein as previous depressive symptoms (categorized as: no = 0 and yes = 1).Women\u2019s experience of IPV before, during and after pregnancy was the main research interest, and for the purpose of the study \u2018intimate partner\u2019 refers to the respondent\u2019s current spouse. The study collected information on IPV experienced by women before, during and after pregnancy using the domestic violence module from the WHO\u2019s Demographic Health Survey Questionnaire. The domestic violence module used in the WHO study was validated for use in Bangladesh and some other countries . A positA woman was coded as having experienced sexual violence by an intimate partner if she reported having been physically forced to have sexual intercourse; having intercourse out of fear, or being forced to perform other sexual acts that she found degrading or humiliating. Psychological IPV was measured by at least one affirmative response to questions asking whether or not the respondent\u2019s husband had insulted her or made her feel bad about herself; humiliated her in front of others; threatened to hurt her or someone close to her; isolated her from friends and family; denied her access to money or other basic resources; or threatened to divorce her. The Cronbach\u2019s alphas for physical, sexual and psychological IPV scale in this study were 0.78, 0.47 and 0.75, respectively.Each participant was asked if she had experienced any of these indicators of IPV during the first six months after birth of her last baby, during her pregnancy, and during the 12 months prior to pregnancy, referred to herein as \u2018IPV after pregnancy\u2019, \u2018IPV during pregnancy\u2019 and \u2018IPV before pregnancy\u2019, respectively. Physical, sexual and psychological IPV before, during and after pregnancy were coded as no (= 0) and yes (= 1).Several socio-demographic variables that have been theoretically and empirically associated with IPV and PPD , 57\u201362 wObstetric and reproductive characteristics such as pregnancy intention , parity , number of children under five years of age , complications during childbirth , mode of birth , a husband\u2019s preference for a son  and timing of breastfeeding initiation  were taken into consideration. Regarding psycho-socio-cultural characteristics, to ascertain the relationship with their mother-in-law, women were asked to evaluate their relationship with their mother-in-law providing a score from 1 to 9, where higher score indicates a more positive relationship  = 1, good (7\u20139 points) = 2).We control for social support given its protective impacts on mental health in general and PPD in particular , 50, 63.Stress can increase the odds of PPD , 67, so High self-esteem can also protect against PPD . To contWomen with more controlling husbands are at risk for both IPV and PPD, an influence we control with a scale comprised of the following items: (a) husband tries to keep her from seeing friends; (b) tries to restrict contact with her family of birth; (c) insists on knowing where she is at all times; (d) does not trust her with any money; (e) gets angry if she speaks to another man; (f) is often suspicious that she is unfaithful; and (g) expects her to ask permission before seeking health care for herself. The responses to these variables are dichotomous (0 = no and 1 = yes). Based on the total scores, women with scores in the bottom third percentile were classified as having husbands who were less controlling (= 0), those with scores in the middle third percentile as having moderately controlling husbands (= 1), and those in the top third as having husbands who were highly controlling (= 2). The controlling behaviors scale was validated for use in Bangladesh and some other countries . The CroWomen who experience a higher degree of autonomy are less likely to report IPV or PPD . We contSPSS version 22.0 for Windows  was used for coding and analyzing the data. We calculated descriptive statistics for mother\u2019s postpartum depressive symptoms, and exposure to IPV as well as all of our control variables. Our analysis proceeded in two stages. First, we conducted a series of cross-tabulations to assess the bivariate relationships between PPD and the relevant covariates and controls and report chi-squares as our measure of significance. A two-tail p-value of <.05 was set to refer the level of statistical significance for all analyses. We then proceeded to a series of multivariate models that allow us to assess the strength of any association between IPV and PPD, controlling for a range of other known influences. These models employed multivariate logistic regression to estimate adjusted odds ratios (AOR) and 95% confidence intervals to compare the strength of the associations between each of the covariates and PPD. To assess the influence of IPV after childbirths on the odds of PPD, we ran four adjusted multivariate logistic regression models\u2014one for each type of IPV after childbirth to assess the separate effects of different forms of IPV on PPD, and one full model for all types of IPV together with the control variables to examine the effects of each type of IPV, controlling for the other. Each model also included the control variables described above. A second set of adjusted multivariate logistic regression models examined the influence of IPV before and during pregnancy on PPD outcomes. Here we ran one model for all types of IPV victimization before pregnancy and another for all types of IPV victimization during pregnancy to examine whether past IPV victimization is associated with experiencing PPD. The multicollinearity of the variables was tested by auditing the variance inflation factors (VIFs), but there was no evidence that this was a problem (VIF\u2019s<2.5).Approximately, a quarter of women (25.8%) had low decision-making autonomy and one-third of the women (29.6%) reported relationship difficulties with their mother-in-law. About, one in three (27.7%) women\u2019s husband had high controlling behaviors and 26.8% of women reported a prior history of depressive symptoms. Approximately 57% of women had high perceived stress, 58.5% of women had low self-esteem and nearly one-third of the women (30%) had low social support.The prevalence of physical IPV during the 12 months before the pregnancy was 52.8%, while the comparative figure for during pregnancy and after childbirth was 35.2% and 32.2% respectively. The prevalence of psychological IPV before pregnancy was highest (67.4%) compared with that during pregnancy (65%) and after childbirth (60.8%). The rate of sexual IPV after childbirth was lower (15.5%) than that of before (21.1%) and during (18.5%) the pregnancy.Out of 426 participants, 150 had total EPDS scores of 10 or above, indicating the prevalence of PPD is 35.2%. We begin by describing the bivariate relationships between the forms and timing of IPV and PPD outcomes among new mothers. As expected, physical, sexual, and psychological IPV both during pregnancy and after childbirth were significantly associated with PPD among the women in this sample. When we examine IPV experiences prior to pregnancy, physical and psychological IPV increase the odds of PPD, but that is not the case for sexual IPV. Overall, 73.7% of women who experienced physical IPV, 56.1% of those experiencing sexual IPV and 52.9% of women experiencing psychological IPV after childbirth also reported PPD. Similarly, during pregnancy, approximately two-thirds of women who experienced physical IPV (66.7%) and sexual IPV (63.3%) and nearly half of the women (52.7%) who experienced psychological IPV also reported PPD. Prior to pregnancy, the corresponding figures were 60.4%, 41.1% and 49.4%, respectively who reported PPD. Moreover, approximately 57.4%, 79.2% and 71.8% of women who experienced all types of IPV before, during and after pregnancy respectively also reported PPD. Bivariate results see  also reiResults reported in As is evidenced in Similar to the influence of IPV victimization after childbirth, results reported in During pregnancy, the picture looks notably different. At this stage, physical, sexual and psychological IPV victimization were all found to be independent risk factors for experiencing PPD after adjusting for other control variables  highlighted that more research utilizing a longitudinal approach is warranted to examine how IPV victimization not only before and during pregnancy but also after childbirth may affect women\u2019s mental health. Though our study is not longitudinal, it includes retrospective and time ordered measures of abuse, thus offering some insight into the longitudinal links between IPV and PPD. To our knowledge, this is the first study from South Asia, particularly from Bangladesh that specifically examined the association of IPV with postpartum depressive symptoms as a function of the type and timing of IPV occurrence. The strength of the study is the large sample size and the introduction of a large number of different socio-demographic, obstetric and reproductive, and psycho-socio-cultural factors. In addition, it is one of the few studies that included various types of IPV experienced at different time periods to explore the likelihood of experiencing PPD. Most importantly, by using internationally recognized scales and questionnaire for this study, the findings are internationally comparable. It is also important to acknowledge that the potential recall bias of the particular cohort of women in this study is greatly reduced because the mothers were surveyed within six months of the birth. Nevertheless, our findings should be interpreted while acknowledging several limitations to the study. Specifically, due to cross-sectional nature of this study, it is not possible to determine the exact temporal relationship between exposure to IPV and PPD. Neither, did we focus on the frequency of IPV over time. In addition, although we collected information on violence and depression before and during pregnancy and in the postpartum period, because the data are cross-sectional it is possible that women\u2019s current depression and violence experiences influence their recollection of prior violence and depressive symptoms. However, regardless of the limitations, we do see changes in these experiences across the three periods, which would indicate that most women are able to disentangle their current state from previous ones and respond accordingly. It is also relevant that the data were collected from one district only, therefore, the findings may not be considered to be representative of the general population. Although a substantial number of predictors were adjusted in this study, some of the important variables were not controlled for, such as the health of the baby and difficult infant temperament. Finally, due to budget and time constraints, we were only able to collect data on exposure to IPV before, during and after pregnancy at a single period, instead of interviewing women at multiple periods. However, this study serves as a foundation for recommending future research on this important issue to explore how IPV victimization before, during and after pregnancy affects the health and well-being of the women of Bangladesh.The high prevalence rate of IPV and its association with postpartum depression reflect the importance of acknowledging both of them as a significant public health concern in Bangladesh. The strong association between IPV victimization around the time of pregnancy and the likelihood a mother will exhibit PPD symptoms reinforces the need to conduct routine screening during pregnancy to identify women with a history of IPV or those currently experiencing IPV who may at risk of developing PPD. This particular cohort of women likely evidence a variety of additional risk factors that further heighten their risks of PPD and could clearly benefit from a range of help and support offerings. In developing countries like Bangladesh, it is important that well-organised referral pathways and support mechanisms and organizations be put in place before a screening program commences . We propS1 File(SAV)Click here for additional data file.", "texts": ["Intimate partner violence (IPV) around the time of pregnancy is a serious public health concern and is known to have an adverse effect on perinatal mental health. In order to craft appropriate and effective interventions, it is important to understand how the association between IPV and postpartum depression (PPD) may differ as a function of the type and timing of IPV victimization. Here we evaluate the influence of physical, sexual and psychological IPV before, during and after pregnancy on PPD.Cross-sectional survey data was collected between October 2015 and January 2016 in the Chandpur District of Bangladesh from 426 new mothers, aged 15\u201349 years, who were in the first six months postpartum. Multivariate logistic regression models were used to estimate the association between IPV and PPD, adjusted for socio-demographic, reproductive and psychosocial confounding factors.Approximately 35.2% of women experienced PPD within the first six months following childbirth. Controlling for confounders, the odds of PPD was significantly greater among women who reported exposure to physical , sexual  or psychological  IPV during pregnancy as opposed to those who did not. However, both before and after pregnancy, only physical IPV evidences a direct effect on PPD. Results highlight the mental health consequences of IPV for women of Bangladesh, as well as the influence of timing and type of IPV on PPD outcomes.The findings confirm that exposure to IPV significantly increases the odds of PPD. The association is particularly strong for physical IPV during all periods and psychological IPV during pregnancy. Results reinforce the need to conduct routine screening during pregnancy to identify women with a history of IPV who may at risk for PPD and to offer them necessary support. Culturally, pregnancy is often viewed as a time of happiness and expectancy in women\u2019s lives, with the welcoming of the next generation and growing anticipation of the joys a new child will bring to the family. At the same time, pregnancy can also be a stressful and anxiety-provoking life event , and manPPD has been recognized as a significant global public health concern due to its profound health consequences for both mothers and their families , 11. PPDIPV includes acts of physical, sexual and psychological coercion along with controlling behaviors against women by a current or former intimate partner , 31. OneAlthough our understanding regarding the links between IPV and PPD is progressing, notable gaps remain. Until recently the majority of research has focussed primarily on physical IPV , 48, andWhilst the literature on IPV in Southeast Asia is growing, it still remains limited and there are few scholarships examining the association between IPV and PPD for women of Bangladesh. To help build this important knowledge base, we assess how the association between IPV and PPD changes as a function of the type and timing of IPV in a population-based sample of new mothers in Bangladesh. The aim of this study is to examine whether:1) recent exposure (occurred after childbirth) to physical, psychological and sexual IPV is associated with PPD in the first six months after childbirth; and 2) prior exposure (occurred before and during pregnancy) to physical, psychological and sexual IPV is also associated with PPD. Understanding the association between PPD outcomes and exposure to different forms of IPV during different periods has clinical implications regarding early detection and targeted preventative measures around the time of pregnancy to support at-risk women.A cross-sectional survey was conducted from October 2015 to January 2016 in two sub-districts of the Chandpur district of Bangladesh. New mothers who visited vaccination centers to receive their baby\u2019s vaccinations were the target population. Married women between 15\u201349 years of age currently living with their husbands for the last two years, and who had at least one child aged six months or younger were eligible for the study. These criteria were used to determine the women\u2019s experience of IPV from their current husband. A multistage random sampling method was adopted to identify vaccination centers from which to draw 426 estimated subjects. Interviewers approached 453 postpartum mothers to reach the desired sample size, yielding a response rate of 94%.The data collection procedure has been described in detail previously in , 51. FacParticipation was entirely voluntary and confidential and did not affect receiving health care in any way. Women who reported an experience of IPV were offered primary counselling services and referrals to local social and psychological services. Women who scored \u226510 on the EPDS were referred to the nearby district hospital for adequate follow-up . The intEthical approval was received for scientific and ethical integrity from the National research ethics committee of Bangladesh Medical Research Council (BMRC/NREC/2013-2016/305) and Griffith University Human Research Ethics Committee (CCJ/41/14/HREC) before conducting the study. The study was also conducted following the WHO guidelines on ethical issues for violence research . InterviThe main outcome of the present study was postpartum depression assessed by using the Bangla version of the Edinburgh Postpartum Depression Scale (EPDS) . The EPDEach participant was asked if she had experienced any of these symptoms during pregnancy or before, referred to herein as previous depressive symptoms (categorized as: no = 0 and yes = 1).Women\u2019s experience of IPV before, during and after pregnancy was the main research interest, and for the purpose of the study \u2018intimate partner\u2019 refers to the respondent\u2019s current spouse. The study collected information on IPV experienced by women before, during and after pregnancy using the domestic violence module from the WHO\u2019s Demographic Health Survey Questionnaire. The domestic violence module used in the WHO study was validated for use in Bangladesh and some other countries . A positA woman was coded as having experienced sexual violence by an intimate partner if she reported having been physically forced to have sexual intercourse; having intercourse out of fear, or being forced to perform other sexual acts that she found degrading or humiliating. Psychological IPV was measured by at least one affirmative response to questions asking whether or not the respondent\u2019s husband had insulted her or made her feel bad about herself; humiliated her in front of others; threatened to hurt her or someone close to her; isolated her from friends and family; denied her access to money or other basic resources; or threatened to divorce her. The Cronbach\u2019s alphas for physical, sexual and psychological IPV scale in this study were 0.78, 0.47 and 0.75, respectively.Each participant was asked if she had experienced any of these indicators of IPV during the first six months after birth of her last baby, during her pregnancy, and during the 12 months prior to pregnancy, referred to herein as \u2018IPV after pregnancy\u2019, \u2018IPV during pregnancy\u2019 and \u2018IPV before pregnancy\u2019, respectively. Physical, sexual and psychological IPV before, during and after pregnancy were coded as no (= 0) and yes (= 1).Several socio-demographic variables that have been theoretically and empirically associated with IPV and PPD , 57\u201362 wObstetric and reproductive characteristics such as pregnancy intention , parity , number of children under five years of age , complications during childbirth , mode of birth , a husband\u2019s preference for a son  and timing of breastfeeding initiation  were taken into consideration. Regarding psycho-socio-cultural characteristics, to ascertain the relationship with their mother-in-law, women were asked to evaluate their relationship with their mother-in-law providing a score from 1 to 9, where higher score indicates a more positive relationship  = 1, good (7\u20139 points) = 2).We control for social support given its protective impacts on mental health in general and PPD in particular , 50, 63.Stress can increase the odds of PPD , 67, so High self-esteem can also protect against PPD . To contWomen with more controlling husbands are at risk for both IPV and PPD, an influence we control with a scale comprised of the following items: (a) husband tries to keep her from seeing friends; (b) tries to restrict contact with her family of birth; (c) insists on knowing where she is at all times; (d) does not trust her with any money; (e) gets angry if she speaks to another man; (f) is often suspicious that she is unfaithful; and (g) expects her to ask permission before seeking health care for herself. The responses to these variables are dichotomous (0 = no and 1 = yes). Based on the total scores, women with scores in the bottom third percentile were classified as having husbands who were less controlling (= 0), those with scores in the middle third percentile as having moderately controlling husbands (= 1), and those in the top third as having husbands who were highly controlling (= 2). The controlling behaviors scale was validated for use in Bangladesh and some other countries . The CroWomen who experience a higher degree of autonomy are less likely to report IPV or PPD . We contSPSS version 22.0 for Windows  was used for coding and analyzing the data. We calculated descriptive statistics for mother\u2019s postpartum depressive symptoms, and exposure to IPV as well as all of our control variables. Our analysis proceeded in two stages. First, we conducted a series of cross-tabulations to assess the bivariate relationships between PPD and the relevant covariates and controls and report chi-squares as our measure of significance. A two-tail p-value of <.05 was set to refer the level of statistical significance for all analyses. We then proceeded to a series of multivariate models that allow us to assess the strength of any association between IPV and PPD, controlling for a range of other known influences. These models employed multivariate logistic regression to estimate adjusted odds ratios (AOR) and 95% confidence intervals to compare the strength of the associations between each of the covariates and PPD. To assess the influence of IPV after childbirths on the odds of PPD, we ran four adjusted multivariate logistic regression models\u2014one for each type of IPV after childbirth to assess the separate effects of different forms of IPV on PPD, and one full model for all types of IPV together with the control variables to examine the effects of each type of IPV, controlling for the other. Each model also included the control variables described above. A second set of adjusted multivariate logistic regression models examined the influence of IPV before and during pregnancy on PPD outcomes. Here we ran one model for all types of IPV victimization before pregnancy and another for all types of IPV victimization during pregnancy to examine whether past IPV victimization is associated with experiencing PPD. The multicollinearity of the variables was tested by auditing the variance inflation factors (VIFs), but there was no evidence that this was a problem (VIF\u2019s<2.5).Approximately, a quarter of women (25.8%) had low decision-making autonomy and one-third of the women (29.6%) reported relationship difficulties with their mother-in-law. About, one in three (27.7%) women\u2019s husband had high controlling behaviors and 26.8% of women reported a prior history of depressive symptoms. Approximately 57% of women had high perceived stress, 58.5% of women had low self-esteem and nearly one-third of the women (30%) had low social support.The prevalence of physical IPV during the 12 months before the pregnancy was 52.8%, while the comparative figure for during pregnancy and after childbirth was 35.2% and 32.2% respectively. The prevalence of psychological IPV before pregnancy was highest (67.4%) compared with that during pregnancy (65%) and after childbirth (60.8%). The rate of sexual IPV after childbirth was lower (15.5%) than that of before (21.1%) and during (18.5%) the pregnancy.Out of 426 participants, 150 had total EPDS scores of 10 or above, indicating the prevalence of PPD is 35.2%. We begin by describing the bivariate relationships between the forms and timing of IPV and PPD outcomes among new mothers. As expected, physical, sexual, and psychological IPV both during pregnancy and after childbirth were significantly associated with PPD among the women in this sample. When we examine IPV experiences prior to pregnancy, physical and psychological IPV increase the odds of PPD, but that is not the case for sexual IPV. Overall, 73.7% of women who experienced physical IPV, 56.1% of those experiencing sexual IPV and 52.9% of women experiencing psychological IPV after childbirth also reported PPD. Similarly, during pregnancy, approximately two-thirds of women who experienced physical IPV (66.7%) and sexual IPV (63.3%) and nearly half of the women (52.7%) who experienced psychological IPV also reported PPD. Prior to pregnancy, the corresponding figures were 60.4%, 41.1% and 49.4%, respectively who reported PPD. Moreover, approximately 57.4%, 79.2% and 71.8% of women who experienced all types of IPV before, during and after pregnancy respectively also reported PPD. Bivariate results see  also reiResults reported in As is evidenced in Similar to the influence of IPV victimization after childbirth, results reported in During pregnancy, the picture looks notably different. At this stage, physical, sexual and psychological IPV victimization were all found to be independent risk factors for experiencing PPD after adjusting for other control variables  highlighted that more research utilizing a longitudinal approach is warranted to examine how IPV victimization not only before and during pregnancy but also after childbirth may affect women\u2019s mental health. Though our study is not longitudinal, it includes retrospective and time ordered measures of abuse, thus offering some insight into the longitudinal links between IPV and PPD. To our knowledge, this is the first study from South Asia, particularly from Bangladesh that specifically examined the association of IPV with postpartum depressive symptoms as a function of the type and timing of IPV occurrence. The strength of the study is the large sample size and the introduction of a large number of different socio-demographic, obstetric and reproductive, and psycho-socio-cultural factors. In addition, it is one of the few studies that included various types of IPV experienced at different time periods to explore the likelihood of experiencing PPD. Most importantly, by using internationally recognized scales and questionnaire for this study, the findings are internationally comparable. It is also important to acknowledge that the potential recall bias of the particular cohort of women in this study is greatly reduced because the mothers were surveyed within six months of the birth. Nevertheless, our findings should be interpreted while acknowledging several limitations to the study. Specifically, due to cross-sectional nature of this study, it is not possible to determine the exact temporal relationship between exposure to IPV and PPD. Neither, did we focus on the frequency of IPV over time. In addition, although we collected information on violence and depression before and during pregnancy and in the postpartum period, because the data are cross-sectional it is possible that women\u2019s current depression and violence experiences influence their recollection of prior violence and depressive symptoms. However, regardless of the limitations, we do see changes in these experiences across the three periods, which would indicate that most women are able to disentangle their current state from previous ones and respond accordingly. It is also relevant that the data were collected from one district only, therefore, the findings may not be considered to be representative of the general population. Although a substantial number of predictors were adjusted in this study, some of the important variables were not controlled for, such as the health of the baby and difficult infant temperament. Finally, due to budget and time constraints, we were only able to collect data on exposure to IPV before, during and after pregnancy at a single period, instead of interviewing women at multiple periods. However, this study serves as a foundation for recommending future research on this important issue to explore how IPV victimization before, during and after pregnancy affects the health and well-being of the women of Bangladesh.The high prevalence rate of IPV and its association with postpartum depression reflect the importance of acknowledging both of them as a significant public health concern in Bangladesh. The strong association between IPV victimization around the time of pregnancy and the likelihood a mother will exhibit PPD symptoms reinforces the need to conduct routine screening during pregnancy to identify women with a history of IPV or those currently experiencing IPV who may at risk of developing PPD. This particular cohort of women likely evidence a variety of additional risk factors that further heighten their risks of PPD and could clearly benefit from a range of help and support offerings. In developing countries like Bangladesh, it is important that well-organised referral pathways and support mechanisms and organizations be put in place before a screening program commences . We propS1 File(SAV)Click here for additional data file.", "Intimate partner violence (IPV) during pregnancy and postpartum is a serious global health problem affecting millions of women worldwide. This study sought to determine the prevalence of different forms of IPV during pregnancy and postpartum and associated factors among women in Dar es Salaam, Tanzania.We conducted a cross-sectional study among 500 women at one to nine months postpartum in three health facilities in the three districts of Dar es Salaam: Temeke, Kinondoni and Illala. Two trained research assistants administered the questionnaire, which aimed to examine sociodemographic characteristics and different forms of IPV.Of the 500 women who were interviewed, 18.8% experienced some physical and/or sexual violence during pregnancy. Forty-one women (9%) reported having experienced some physical and/or sexual violence at one to nine months postpartum. Physical and/or sexual IPV during pregnancy was associated with cohabiting  and having a partner who was 25 years old or younger . Postpartum, physical and/or sexual IPV was associated with having a partner who was 25 years old or younger .We found that IPV is more prevalent during pregnancy than during the postpartum phase. There is also continuity and maintenance of IPV during and after pregnancy. These results call for policy and interventions to be tailored for pregnant and postpartum women. Intimate partner violence (IPV) has been recognized as a highly prevalent and important public health problem affecting the wellbeing and health of millions of women and children worldwide. Globally, it has been estimated that one-third of women will experience some form of physical and/or sexual violence in their lifetime and that one in three homicides of women are committed by intimate partners , 2.Population-based studies across the world have found the prevalence of physical IPV during pregnancy to be between 1% and 28% . A systeThe adverse effects of IPV during pregnancy for both mothers and their children have been well documented \u201310. SeveWhile there is increasing evidence of the prevalence of physical and/or sexual violence in pre-and postnatal cases in sub-Saharan African countries, there is still limited data about the prevalence of different forms of pregnancy-related IPV and factors associated with IPV during and after pregnancy. This study aimed to determine the prevalence, nature and factors associated with IPV among pregnant and postpartum women in Tanzania.The study was conducted between December 2014 and March 2015 among women attending clinics for children under the age of 5  in three health centers in Dar es Salaam. The under-five clinics promote healthy behavior and family planning, as well as offering immunizations and extra care for low birthweight babies or babies born to HIV-positive mothers. The three health centers were intentionally selected from the Temeke, Illala and Kinondoni districts of Dar es Salaam because they offered relatively similar services and had a representative number of attendees (ranging from 50 to 200 children per day). The health center in Kinondoni mainly provided antenatal care and under-five clinics, while the other two health centers offered a wider range of services, including in-patient services.The mothers were recruited after their visits to the under-five clinic. All attending mothers aged 18 years and older who were physically fit and without cognitive impairment were invited to participate in the study. The response rate was 97%: 541 women were approached to take part in the study and only 18 declined to participate. We excluded 23 women from the study: 15 for security reasons (they attended the clinics with their partners and such partner presence could be intrusive and unsafe) and eight because they were not the biological mothers.We used a consecutive sampling technique to select study participants for the interviews. A research assistant explained the nature of the study to each woman in a separate private room, read the consent form and obtained her verbal consent. Due to the sensitive nature and cultural context of the study, we used a verbal consent since a written consent might have implied legal consequences.Two trained female research assistants with diplomas in nursing and midwifery administered the study questionnaires in Kiswahili, the most widely spoken language in Tanzania. The participants were not financially compensated, but refreshments were provided during the interviews. Women perceived to be in immediate danger were referred to gender-based violence intervention units, which were led by trained medical staff and social workers in the respective health centers.The study received ethical approval from the National Institute of Medical Research (NIMR) in Tanzania and from the University of Heidelberg. It was endorsed by regional medical officers and medical officers in charge in the respective hospitals. We observed a protocol regarding the protection of human subjects which adheres to the WHO ethical guidelines . ParticiThe structured questionnaire included information about the participants\u2019 sociodemographic characteristics, such as age, education, employment status and marital status. The participants also provided information about their partner\u2019s age, education and employment status, as well as the sex and age of the child.Intimate partner violence was captured through the instrument from the WHO multi-country study, which includes five forms of IPV . Women wPhysical violence (6 questions): Has your partner ever; slapped you or thrown something at you that could hurt you? Pushed you, shoved you or pulled your hair? Hit you with his fist or with something else that could hurt you? Kicked you, dragged you about or beaten you up? Attempted to choke you or burned you on purpose? Threatened to use or actually used a gun, knife or other weapon against you?Sexual violence (3 questions): Has your partner ever; ever forced you to have sexual intercourse by threatening you, holding you down or hurting you in some way? Did you ever agree to have intercourse when you did not want to because you were afraid of what your husband/ partner might do if you refused? Did your partner or any other partner ever force you to do something sexual  that you did not want to do?Psychological violence (4 questions): Has your partner ever; insulted you or made you feel bad about yourself? Belittled or humiliated you in front of other people? Done things to scare or intimidate you on purpose ? Threatened to hurt you or someone you care about?Controlling behavior (5 questions): Has your partner ever; tried to keep you from seeing your friends? Tried to restrict contact with your family of birth? Insisted on knowing where you are all times? Acted jealous and get angry if you speak with another man? Often been suspicious that you are unfaithful?Economic violence (two questions): Has your partner ever; taken your earnings or savings from you against your will? Refused to give you money for household expenses, even when he has money for other things?The scale has been validated and used in Tanzania .Data analysis was done using STATA version12. A woman was considered to have experienced IPV during and after pregnancy if she answered yes to any question within any of the five forms of IPV.Descriptive statistics included frequencies of each variable. The first step in the analysis was to screen all potential factors that could influence the dependent variable. Variables that showed a p-value of <0.3 in the univariate models were selected and used in the logistic regression model analysis, associated factors controlled each other. A p-value <0.05 was considered to be significant and an odds ratio <1 indicates the likelihood of reduced risk, while an odds ratio >1 could be considered an increased risk.We interviewed 500 women from the three selected under-five clinics in Dar es Salaam: 168 (33.6%) women in Kinondoni, 182 (36.4%) in Temeke and 150 (30%) in Illala. The mean age of participants was 27 years, ranging from 18 to 48 years; 116 women (23.2%) were aged 18\u201321 years, 332 (66.4%) were aged 22\u201335 years and 52 (10.4%) were aged 36 years or older. The majority of women  were married; the rest were cohabiting  or single . The lengths of their relationships ranged from 1 to 28 years. For more than half the women  among the participants, followed by secondary education and above . A large number of the participants were unemployed ; the rest were self-employed  or employed .The participants\u2019 partners had a mean age of 32 years, ranging from 18 to 65 years. Of them, 98 (16.6%) were aged 18\u201325 years, 251 (50.2%) were aged 26\u201335 years and 151 (30.2%) were aged 36 years or older. The majority of partners  had a primary school education or below and the rest had secondary education and above. More than half of the partners were self-employed  and the rest were employed.Of the participants, 18.8% (n = 94) reported experiencing some form of physical and/or sexual IPV during the index pregnancy, 12.4% (n = 62) reported experiencing some act of physical violence in the index pregnancy and 9% (n = 45) reported experiencing some act of sexual violence. In addition, 31% (n = 155) reported experiencing psychological violence, 15% (n = 75) reported experiencing economic violence and 48.4% (n = 242) reported experiencing controlling behavior during their index pregnancy. Some form of psychological and/or controlling behavior was experienced by 58.2% (n = 291) of the participants.Women who were cohabiting were more likely to experience physical and/or sexual IPV in the index pregnancy compared to their single counterparts . If they had partners aged 25 years or younger, they were more likely to experience physical and/or sexual IPV during their index pregnancy than women with partners aged 26\u201335 years . Other factors were not significant .Married women were more likely to experience psychological violence in the index pregnancy than their single counterparts . Women who were cohabiting , single (AOR 8.2 CI 4.2\u201315.8) or who had a partner with a primary school education  were more likely to experience economic violence.There was also an overlap between different forms of IPV during pregnancy .Some participants reported IPV between one and nine months postpartum. 8.2% (n = 41) reported physical and/or sexual violence, 5.2% (n = 26) reported physical violence and 3.8% (n = 19) reported sexual violence. Psychological violence postpartum was reported by 17.8% (n = 89) of participants, economic violence by 11.4% (n = 57) and controlling behavior by 44.4% (n = 222).In addition, some participants only experienced violence postpartum and not during pregnancy. Of all the participants, 5% (n = 25) experienced psychological IPV, 2.6% (n = 13) experienced physical IPV, 1.6% (n = 8) experienced sexual IPV, 2.6% (n = 13) experienced economic IPV and 4.6% (n = 23) experienced controlling behaviors.Women with partners aged 25 years or younger were more likely to experience physical and/or sexual violence postpartum  reported physical and/or sexual IPV and 12.6% (n = 63) experienced psychological IPV and/or controlling behaviors both during pregnancy and postpartum. 13.8% (n = 69) of the participants reported experiencing physical and/or sexual IPV only during pregnancy, and 3.4% (n = 17) of them experienced physical and/or sexual IPV for the first time postpartum.Thus, 18.6% (n = 93) of the participants experienced postpartum physical and/or sexual IPV, which was a continuation of their pre-delivery experience. However, postpartum IPV was a new experience for a few women . There were marked differences between the victims and perpetrators in both sub-groups in terms of age, marital status and partner age. Women aged 21 years and younger experienced more physical and sexual IPV during pregnancy only  than their counterparts, while those between the ages of 22 and 35 years experienced new physical and/or sexual IPV postpartum . Single women experienced more physical and/or sexual IPV during pregnancy alone , while married women experienced more physical and/or sexual IPV postpartum . Men who were under the age of 25 years were less likely than their counterparts to be the perpetrators of physical and/or sexual IPV during pregnancy  and postpartum .This study found IPV during pregnancy to be more prevalent than IPV at one to nine months postpartum. It further found a 18.6% rate of physical and/or sexual violence during the index pregnancy and an 8% frequency postpartum. Controlling behaviors were the most prevalent form of IPV both during pregnancy (48.4%) and at one to nine months postpartum (44%), followed by psychological IPV .These rates are within the 2% to 57% range of different forms of IPV during pregnancy reported in a systematic review of African countries . HoweverTo our best knowledge, this is the first study to investigate psychological and economic abuse and controlling behavior during and after pregnancy in Tanzania. The high rates of controlling behavior and psychological and economic abuse are of great concern, as a study conducted among pregnant women in the USA found a strong link between psychological IPV and posttraumatic stress disorder . AdditioThe decline of IPV after one to nine months postpartum found in this study is consistent with some other studies which also reported a decline of IPV during the postpartum phase . HoweverThis study found that women are still likely to suffer postpartum IPV, even if they did not experience IPV during pregnancy. Although the postpartum IPV percentages might be smaller than those of IPV during pregnancy, such acts of violence still call for attention due to the potential adverse effects of IPV in the postpartum phase . There iIn the univariate analysis higher odds for women with partners aged 25 or younger was observed. This conforms to the findings of other studies. For example, IPV during pregnancy was associated with mothers\u2019 younger age in Tanzania . MoreoveThis study has several limitations which have to be taken into account. First, it was a cross-sectional study and thus cannot establish a causal link between IPV during the pregnancy and postpartum. Second, since the study was conducted in urban health facilities in Dar es Salaam, the results cannot be extrapolated to represent the situation in the entire country. Additionally, due to the sensitive nature of the study in terms of social stigma and IPV being seen as a private matter, the participants may have underreported IPV. The exclusion of women accompanied by their partners may have resulted in an underrepresentation of severe cases of IPV, especially controlling behaviors.Although the study was cross-sectional, meaning recall bias was inevitable, participants were given clues to assist them in remembering what they went through during and after pregnancy. We also took steps to ensure we established rapport with the women so they could speak freely.The findings reveal that IPV is prevalent and the rates of controlling behavior are high both during pregnancy and postpartum. As highlighted in the results, maintenance and continuity of IPV persisted during pregnancy and postpartum. Some new cases of IPV emerged during the postpartum phase, but some IPV also stopped after pregnancy. These findings show that women can suffer IPV in these two phases of their life, which could lead to severe psychological and physical health implications. These results call for policy and interventions to be tailored to pregnant and postpartum women.S1 Fig(TIF)Click here for additional data file.S2 Fig(TIF)Click here for additional data file.S1 File(PDF)Click here for additional data file."]}
{"representative": "Violence related injury is a serious public health issue all over the world. This study aims to assess the association between several socio-economic factors and intimate partner violence (IPV) in Nepal.A cross-sectional study was conducted among 236 women working in carpet and garment factories in Kathmandu, Nepal. Interviews were conducted to collect quantitative data on three forms of IPV, namely physical violence, psychological violence and sexual violence, as well as on a number of potentially associated factors.p\u00a0=\u00a00.025 for physical IPV; OR\u00a0=\u00a06.94, p\u00a0=\u00a00.008 for sexual IPV; OR\u00a0=\u00a03.42, p\u00a0=\u00a00.043 for psychological IPV], alcohol consumption of the husband , education of the husband above primary level , and economic dependency of the woman on the husband .Twenty-two percent of women experienced sexual IPV, 28% physical IPV and 35% psychological IPV at least once in the last 12\u00a0months. The variables independently associated with at least one form of IPV were: age of the woman >29\u00a0years [OR\u00a0=\u00a04.23, This study identified various factors associated with IPV and showed that economic dependence of wives on their husband was among the most important ones. Thus, for the prevention of IPV against women, long term strategies aiming at livelihood and economic empowerment as well as independence of women would be suggested. Intimate Partner Violence (IPV) against women is a serious public health concern and a human rights issue worldwide \u20133. IPV rIn Nepal, IPV against women is encouraged due to the male dominance social system which discriminates against women and is also connected to cultural factors that limit women\u2019s choices to leave a violent marriage . Women hThe risk for IPV in Nepal also seems dependent on various socio-economic factors. Most of the women from under-privileged castes and ethnic groups are at higher risk for IPV than women from higher castes . In addiIn the Nepalese context, economic dependency of women on their husband is generally high as compared to the western part of the world , which mTherefore, this study aimed at estimating the prevalence of physical, sexual and psychological IPV and at studying demographic, educational, social and economic factors associated with IPV among married women in the reproductive age between 15 and 49\u00a0years working in factories in Kathmandu.This cross-sectional study used a standardized, closed ended questionnaire administered orally by interviewers to married women of reproductive age (15\u201349\u00a0years) working in factories in Kathmandu, Nepal. Four carpet and garment factories were included in the study, because the carpet and garment industry is traditionally employing mostly women. The factories were selected on basis of convenience. The study population comprised of only married women currently living with their husband and the sample size calculation was done with OpenEpi software . The samThe total number of respondents included in the study was 236, as it was the required sample size of the study. Data collection was done using purposive sampling technique, meaning that sampling was done until the number of data reached the required sample size i.e. 236. Four factories were included to reach the required sample size. None of the eligible women refused to participate in the study nor did not complete the interview resulting in a response rate of 100%.The structured closed ended questionnaire was constructed by taking the reference from standard survey tools used by the Government of Nepal for the NDHS 2011 for collecting information about IPV at national level . The queThe first part of the questionnaire included general characteristics of women such as their age and their age at first marriage (>20\u00a0years/20\u00a0years or above according to NDHS ). The woThree forms of IPV were studied, namely physical violence, psychological violence and sexual violence. Physical violence included those acts causing physical harm such as hitting, beating, kicking, slapping, dragging or any form of physical injury. Psychological violence included those acts causing psychological harm such as insulting, threatening, humiliating or controlling on unnecessary activities and sexual violence, including forced sex. The time period for experiencing violence was during the last 12 months. The presence of any form of violence among those three types of violence was considered as the presence of IPV. The response was categorized binary as Yes and No.Psychological violence was assessed by the question: \u2018Did your husband ever insult you or make you feel bad about yourself?\u2019 Physical violence was assessed by a single question: \u2018Have you ever been hit, slapped, kicked or done anything else to physically hurt by your husband at times?\u2019 Sexual violence was assessed by a question: \u2018Has your husband ever forced you to have sex when you did not wish to do so?\u2019 The responses for all forms of IPV were in Yes/No form and for the severity assessment, the response options were \u2018often\u2019, \u2018sometimes\u2019, and \u2018not at all\u2019. The participants were also asked about their knowledge about IPV against women with the question: \u2018Do you know what intimate partner violence is?\u2019p\u00a0<\u00a00.05 for the Pearson value of the Chi-Square test was taken as indicating significance. Only factors significant in the Chi-Square tests (data not shown) were used in the bivariate logistic regression models presented in Tables\u00a0Data was entered and analyzed in SPSS 22 for Windows. Chi-square tests were conducted to assess any association between the three forms of IPV and relevant socio-demographic factors. A significance level of Table\u00a0Psychological violence was the form of violence most often reported and 35% reported that they had experienced psychological IPV by their husbands. Women, who reported that they were hit, slapped, kicked or physically harmed by their husband , included 28% of the respondents and 22% had suffered from sexual IPV.Table\u00a0Table\u00a0Several other variables only showed an association with sexual IPV, but only when not adjusted for the other variables in the table: women having more than 2 children, those having a love marriage, those with a lower level of education, those with a lower level of education of their husband, those who were economically dependent on their husband, those who had lack of knowledge about IPV and those who had decision making capacity were more likely to have experienced sexual IPV. However, all these associations became insignificant after adjusting for the other variables in Table Table\u00a0Several other variables only showed an association with sexual IPV, when not adjusted for the other variables in the table: Women having more than 2 children, those who had a lower level of education and those who had a lack of knowledge about IPV were more likely to having experienced psychological IPV. However, all of these associations became insignificant after adjusting for the other variables in Table The first aim of our study was to study the prevalence of three different forms of IPV among female factory workers aged 15\u201349\u00a0years in Kathmandu Nepal. It was found that of 22% of women reported having experienced sexual IPV, 28% reported physical IPV and 35% reported psychological IPV at least once in their last 12\u00a0months. The NDHS 2011, a national level survey, reported slightly lower figures with 14% of women aged 15\u201349\u00a0years reporting sexual abuse by their husband at least once in their lifetime, 23% of them reporting physical abuse, one thirds of them reporting physical, sexual or psychological abuse once in their lifetime [As our second aim, this study focused on a number of relevant factors potentially affecting IPV which included age of women, age of women at their first marriage, number of children (parity), marriage type, education of women, education of husbands, economic dependence of women on their husbands, decision making capacity of women, knowledge about IPV on women and alcohol use of the husband. All these factors except for age of women at first marriage were significantly associated with the different types of IPV, but for most of the factors the association disappeared when adjusting for the other factors. The variables that were independently associated with at least one form of IPV were: higher age of the woman, alcohol consumption of the husband, low education of the husband and economic dependency of the woman on the husband. Out of these four variables, two of them showed a consistent association with all three forms of IPV even when adjusted for all other factors: higher age of women and alcohol use of the husband. Women whose age was 29\u00a0years and over had 3\u20137 times higher odds of having experienced psychological, physical or sexual IPV than younger women. The IPV risk for older women may increase due to more marital quarrelling that may be followed by violence , or oldeAlso, alcohol consumption of the husband was a strong independent risk factor for all forms of IPV. Alcohol consumption among men in Nepal is very high in comparison with the alcohol use of women . Our resEconomic dependence on the husband was found to be a risk factor for all forms of IPV in this study and after adjustment remained significant for physical and psychological IPV. Previous studies about the association between IPV and economic dependence of women on their husband also showed that the risk of violence against women was higher for women who were economically dependent on their husband . In NepaSeveral other factors showed some association with IPV, but only in the unadjusted models. E.g. women with an arranged marriage were less likely to report IPV. In Nepal, marriages that were arranged by their family are more frequent than love marriages and this type of marriage is also more secured by the families that arranged the marriage .Knowledge of women about IPV was found to be the protective factor for all forms of IPV in the study, but only without adjusting for other variables. A previous study about IPV conducted in Nepal concluded that women\u2019s decision making autonomy was a strong predictor of IPV on women . HoweverWe also found that age at first marriage was not associated with any form of IPV and therefore the variable was not included in the logistic models. This is in line with another study, which describes causes of IPV showing that age at marriage was not associated with IPV .Our study has limitations and it is crucial to note that the data collection was cross-sectional and no conclusions regarding causal relationships can be drawn. The study population is also limited to factory workers in Kathmandu and the results may be different in rural areas or in other professional sectors. However, the response rate was extremely high which limits a potential selection bias towards only excluding women who may be absent from work due to IPV. Our study also relied on self-reported data and due to the fact that IPV and the associated factors are a sensitive issue, we cannot rule out potential under-reporting of IPV.In summary, we conclude that the prevalence of IPV is high in this group of women and that the odds of IPV was higher in women of higher age, for those with alcohol consumption of the husband, with low education of the husband and with economic dependency on the husband. Future research should identify underlying reasons for the high level of IPV.The findings from this study are important in order to make Nepalese women aware of the problem and to enable advocacy about IPV. A holistic approach is essential to gain family and community trust as well as support for women at the micro, meso and macro levels for the prevention and control of IPV issues in Nepal . The res", "texts": ["Violence related injury is a serious public health issue all over the world. This study aims to assess the association between several socio-economic factors and intimate partner violence (IPV) in Nepal.A cross-sectional study was conducted among 236 women working in carpet and garment factories in Kathmandu, Nepal. Interviews were conducted to collect quantitative data on three forms of IPV, namely physical violence, psychological violence and sexual violence, as well as on a number of potentially associated factors.p\u00a0=\u00a00.025 for physical IPV; OR\u00a0=\u00a06.94, p\u00a0=\u00a00.008 for sexual IPV; OR\u00a0=\u00a03.42, p\u00a0=\u00a00.043 for psychological IPV], alcohol consumption of the husband , education of the husband above primary level , and economic dependency of the woman on the husband .Twenty-two percent of women experienced sexual IPV, 28% physical IPV and 35% psychological IPV at least once in the last 12\u00a0months. The variables independently associated with at least one form of IPV were: age of the woman >29\u00a0years [OR\u00a0=\u00a04.23, This study identified various factors associated with IPV and showed that economic dependence of wives on their husband was among the most important ones. Thus, for the prevention of IPV against women, long term strategies aiming at livelihood and economic empowerment as well as independence of women would be suggested. Intimate Partner Violence (IPV) against women is a serious public health concern and a human rights issue worldwide \u20133. IPV rIn Nepal, IPV against women is encouraged due to the male dominance social system which discriminates against women and is also connected to cultural factors that limit women\u2019s choices to leave a violent marriage . Women hThe risk for IPV in Nepal also seems dependent on various socio-economic factors. Most of the women from under-privileged castes and ethnic groups are at higher risk for IPV than women from higher castes . In addiIn the Nepalese context, economic dependency of women on their husband is generally high as compared to the western part of the world , which mTherefore, this study aimed at estimating the prevalence of physical, sexual and psychological IPV and at studying demographic, educational, social and economic factors associated with IPV among married women in the reproductive age between 15 and 49\u00a0years working in factories in Kathmandu.This cross-sectional study used a standardized, closed ended questionnaire administered orally by interviewers to married women of reproductive age (15\u201349\u00a0years) working in factories in Kathmandu, Nepal. Four carpet and garment factories were included in the study, because the carpet and garment industry is traditionally employing mostly women. The factories were selected on basis of convenience. The study population comprised of only married women currently living with their husband and the sample size calculation was done with OpenEpi software . The samThe total number of respondents included in the study was 236, as it was the required sample size of the study. Data collection was done using purposive sampling technique, meaning that sampling was done until the number of data reached the required sample size i.e. 236. Four factories were included to reach the required sample size. None of the eligible women refused to participate in the study nor did not complete the interview resulting in a response rate of 100%.The structured closed ended questionnaire was constructed by taking the reference from standard survey tools used by the Government of Nepal for the NDHS 2011 for collecting information about IPV at national level . The queThe first part of the questionnaire included general characteristics of women such as their age and their age at first marriage (>20\u00a0years/20\u00a0years or above according to NDHS ). The woThree forms of IPV were studied, namely physical violence, psychological violence and sexual violence. Physical violence included those acts causing physical harm such as hitting, beating, kicking, slapping, dragging or any form of physical injury. Psychological violence included those acts causing psychological harm such as insulting, threatening, humiliating or controlling on unnecessary activities and sexual violence, including forced sex. The time period for experiencing violence was during the last 12 months. The presence of any form of violence among those three types of violence was considered as the presence of IPV. The response was categorized binary as Yes and No.Psychological violence was assessed by the question: \u2018Did your husband ever insult you or make you feel bad about yourself?\u2019 Physical violence was assessed by a single question: \u2018Have you ever been hit, slapped, kicked or done anything else to physically hurt by your husband at times?\u2019 Sexual violence was assessed by a question: \u2018Has your husband ever forced you to have sex when you did not wish to do so?\u2019 The responses for all forms of IPV were in Yes/No form and for the severity assessment, the response options were \u2018often\u2019, \u2018sometimes\u2019, and \u2018not at all\u2019. The participants were also asked about their knowledge about IPV against women with the question: \u2018Do you know what intimate partner violence is?\u2019p\u00a0<\u00a00.05 for the Pearson value of the Chi-Square test was taken as indicating significance. Only factors significant in the Chi-Square tests (data not shown) were used in the bivariate logistic regression models presented in Tables\u00a0Data was entered and analyzed in SPSS 22 for Windows. Chi-square tests were conducted to assess any association between the three forms of IPV and relevant socio-demographic factors. A significance level of Table\u00a0Psychological violence was the form of violence most often reported and 35% reported that they had experienced psychological IPV by their husbands. Women, who reported that they were hit, slapped, kicked or physically harmed by their husband , included 28% of the respondents and 22% had suffered from sexual IPV.Table\u00a0Table\u00a0Several other variables only showed an association with sexual IPV, but only when not adjusted for the other variables in the table: women having more than 2 children, those having a love marriage, those with a lower level of education, those with a lower level of education of their husband, those who were economically dependent on their husband, those who had lack of knowledge about IPV and those who had decision making capacity were more likely to have experienced sexual IPV. However, all these associations became insignificant after adjusting for the other variables in Table Table\u00a0Several other variables only showed an association with sexual IPV, when not adjusted for the other variables in the table: Women having more than 2 children, those who had a lower level of education and those who had a lack of knowledge about IPV were more likely to having experienced psychological IPV. However, all of these associations became insignificant after adjusting for the other variables in Table The first aim of our study was to study the prevalence of three different forms of IPV among female factory workers aged 15\u201349\u00a0years in Kathmandu Nepal. It was found that of 22% of women reported having experienced sexual IPV, 28% reported physical IPV and 35% reported psychological IPV at least once in their last 12\u00a0months. The NDHS 2011, a national level survey, reported slightly lower figures with 14% of women aged 15\u201349\u00a0years reporting sexual abuse by their husband at least once in their lifetime, 23% of them reporting physical abuse, one thirds of them reporting physical, sexual or psychological abuse once in their lifetime [As our second aim, this study focused on a number of relevant factors potentially affecting IPV which included age of women, age of women at their first marriage, number of children (parity), marriage type, education of women, education of husbands, economic dependence of women on their husbands, decision making capacity of women, knowledge about IPV on women and alcohol use of the husband. All these factors except for age of women at first marriage were significantly associated with the different types of IPV, but for most of the factors the association disappeared when adjusting for the other factors. The variables that were independently associated with at least one form of IPV were: higher age of the woman, alcohol consumption of the husband, low education of the husband and economic dependency of the woman on the husband. Out of these four variables, two of them showed a consistent association with all three forms of IPV even when adjusted for all other factors: higher age of women and alcohol use of the husband. Women whose age was 29\u00a0years and over had 3\u20137 times higher odds of having experienced psychological, physical or sexual IPV than younger women. The IPV risk for older women may increase due to more marital quarrelling that may be followed by violence , or oldeAlso, alcohol consumption of the husband was a strong independent risk factor for all forms of IPV. Alcohol consumption among men in Nepal is very high in comparison with the alcohol use of women . Our resEconomic dependence on the husband was found to be a risk factor for all forms of IPV in this study and after adjustment remained significant for physical and psychological IPV. Previous studies about the association between IPV and economic dependence of women on their husband also showed that the risk of violence against women was higher for women who were economically dependent on their husband . In NepaSeveral other factors showed some association with IPV, but only in the unadjusted models. E.g. women with an arranged marriage were less likely to report IPV. In Nepal, marriages that were arranged by their family are more frequent than love marriages and this type of marriage is also more secured by the families that arranged the marriage .Knowledge of women about IPV was found to be the protective factor for all forms of IPV in the study, but only without adjusting for other variables. A previous study about IPV conducted in Nepal concluded that women\u2019s decision making autonomy was a strong predictor of IPV on women . HoweverWe also found that age at first marriage was not associated with any form of IPV and therefore the variable was not included in the logistic models. This is in line with another study, which describes causes of IPV showing that age at marriage was not associated with IPV .Our study has limitations and it is crucial to note that the data collection was cross-sectional and no conclusions regarding causal relationships can be drawn. The study population is also limited to factory workers in Kathmandu and the results may be different in rural areas or in other professional sectors. However, the response rate was extremely high which limits a potential selection bias towards only excluding women who may be absent from work due to IPV. Our study also relied on self-reported data and due to the fact that IPV and the associated factors are a sensitive issue, we cannot rule out potential under-reporting of IPV.In summary, we conclude that the prevalence of IPV is high in this group of women and that the odds of IPV was higher in women of higher age, for those with alcohol consumption of the husband, with low education of the husband and with economic dependency on the husband. Future research should identify underlying reasons for the high level of IPV.The findings from this study are important in order to make Nepalese women aware of the problem and to enable advocacy about IPV. A holistic approach is essential to gain family and community trust as well as support for women at the micro, meso and macro levels for the prevention and control of IPV issues in Nepal . The res"]}
{"representative": "This paper investigates gender differences in persistence of intimate partner violence (IPV), for those remaining or leaving an abusive relationship. We followed a sample of males and females to examine whether leaving an abusive partner may alter the continuity of victimization.Data were taken from the 21 and 30-year follow-ups of the Mater Hospital and University of Queensland Study of Pregnancy (MUSP) in Australia. A cohort of 1265 respondents, including 874 females and 391 males, completed a 21-item version of the Composite Abuse Scale.We found proportionally similar rates of IPV victimization for males and females at both the 21 and 30\u00a0year follow-ups. Females who reported they had an abusive partner at the 21\u00a0year follow-up were more likely to subsequently change their partner than did males. Harassment and then emotional abuse appeared to have a stronger association for females leaving a partner. For males, a reported history of IPV was not significantly associated with leaving the partner. There was no significant association between leaving (or not) a previous abusive relationship and later victimization, either for male or female respondents.Changing a partner does not interrupt the continuity of victimization either for male or female respondents, and previous IPV victimization remained a determining factor of re-abuse, despite re-partnering. Intimate partner violence (IPV) may occur repeatedly in the context of some intimate relationships . There iPrior research following those who have previously experienced IPV has been limited and inconclusive. Only a small number of scholars have suggested that changing a partner may reduce IPV perpetration , 8 and vlife course perspective suggests that particular periods of the life course may be associated with higher rates of IPV. Characteristics of early adulthood  contribute to a greater risk of IPV in this period. Afterwards, developmental changes  may protect individuals from subsequent victimization/ perpetration- regardless of leaving or staying with a partner victimization and staying in an abusive relationship, are related to the following factors: marital status, lower socio-economic status, presence of children, history of child abuse, and poor mental health , 39\u201343.what is your present marital status? Categories comprised single/never married, living together, married or separated. Education levels included high school or less, diploma and college and university. Having a child was dichotomized into yes and no. Participants were asked about their family income which was defined as gross income before tax. Then using the Australian National Poverty Line as a guide [low income and the rest into higher income. For measuring history of sexual child abuse 21-year respondents were asked whether they had experienced being pressured or forced to have sexual contact before they were 16\u00a0years. Depression was assessed using the Center for Epidemiologic Studies Depression Scale (CES-D) which is a widely-used self-report scale [during the last 12\u00a0months have your sexual partners been: only the opposite sex, only the same sex and both sexes. We then categorised respondents into two categories of heterosexual and homo/bisexual.All participants were about 21 and 30\u00a0years of age at each follow up, so we did not adjust for the age differences in the cohort. Marital status was measured by the question  a guide , we catert scale . It contrt scale , 47. Sexp-value<\u20090.05 for significance. In Table\u00a0In Table\u00a0Among 1265 21-year-old participants who were in a relationship, 6.1% were married and 93.9% were living together. 11.1% of respondents had children.p\u2009=\u20090.07) is experienced more often by females. By contrast, 21-year-old males more frequent report being physically abused. At 30, there are no gender differences in any form IPV.Table Table Table A further detailed analysis (data not shown) suggests that although the association between having children and females\u2019 leaving their partners is negative Table , when moTable p\u2009=\u20090.08). For females we note that 55.7% of those experiencing IPV changed partners, while 42.9% of those not experiencing IPV changed partners (p\u2009<\u2009\u00a00.001) by the 30\u00a0year follow up. Females who reported IPV at 21\u00a0years and remained with their partners, were no more likely to be abused at 30\u00a0years compared to females who had changed partners . A further interaction terms between the experience of IPV at 21 (non-abused/abused) as primary variable and change of partner (stay/change) as moderator was conducted to predict the experience of IPV at 30 (non-abused/abused) separately for females and males (data not shown in a table). Consistent with the findings in Fig. 95\u2009=\u20090.44\u20131.35). In contrast, the primary effect of experiencing IPV at 21 remains a robust significant predictor for experiencing IPV at 30\u00a0years. For males, no statistically significant difference in experiencing IPV at 30\u00a0years is observed between males who left their abusive or non-abusive partners . These findings were independent of a range of potential confounding factors.Figure\u00a0p\u2009<\u2009\u00a00.00 by the 3The current study has compared males and females in the continuity of IPV victimization at 21 and 30\u00a0years of age. A cohort of 1260 cases was followed to determine whether early IPV victimization was associated with leaving the prior partner and subsequent IPV. In addition, we followed both males and females to examine how a change of abusive partners may alter the continuity of victimization.p\u2009<\u2009\u00a00.0001). Despite this decline in the IPV rate across time, there was a robust significant association between early victimization and re-victimization for both males and females. We also found that a substantial proportion of females (55.7%) and males (51.0%) who report experiencing IPV at 21\u00a0years left their partners (p\u2009>\u20090.05). Victimized males at 21\u00a0years were no more likely to change partners, than those not experiencing IPV at 21\u00a0years. These findings were not affected by any of the sociodemographic factors that were considered. Harassment and then emotional abuse appeared to have a higher association with leaving partner in females. Relationship change did not appear to prevent males and females from the continued experience of victimization. We found experiencing IPV at 21 remains a robust significant predictor for experiencing IPV at 30\u00a0years, regardless of whether there is a change of partner.The results of this study suggest that rates of IPV victimization declined from 21 to the 30\u00a0year follow up . Features of this life course stage include instability  and tendency to postpone adults\u2019 responsibilities , which may contribute to a higher rate of IPV victimization at this period [The observed decline in IPV victimization from 21 to 30\u00a0years may reflect the longer period in which 21-year respondents were asked about their experiences, compared to that of 30\u00a0years (last year). Nevertheless, this finding is consistent with a s period , 12, 13.s period .A relationship between early and further victimization supports previous research which suggests that earlier victimization may be taken to mean violence is considered a normal aspect of intimate relationships. Prior experiences of family violence may lead to cumulative disadvantages  which negatively affect the nature of future relationships , 48\u201351.Slightly higher rates of leaving the abusive partner in females seems to be consistent with other research indicating that females have disproportionately higher rates of relationship termination than males . ConsideWe also found no support for the effectiveness of leaving an abusive partner. This finding is in line some previous studies which find no significant difference between those who stayed or changed partners , 15. HowA body of research has shown that earlier victimization may lead to long-lasting consequences for survivors like fear, posttraumatic stress, anxiety and disempowerment . SurvivoThis study has several strengths: IPV was assessed by a validated measure at 21 and 30\u00a0years. We also used the longitudinal data from a large prospective cohort of both males and females and adjusted for a range of confounding factors. We have found that leaving an abusive relationship makes no significant difference to experiencing further IPV and early IPV victimization remains the strongest predictor of re-abuse, despite changing partner. The current work has extended existing knowledge about IPV victimization experienced in relationships with different partners. Our findings raise the question of whether there are characteristics of those affected by IPV and socio-cultural factors, not measured in this study, that need to be identified and addressed if IPV and its consequences are to be reduced.gender specific IPV interventions. For example, we found similar rates of IPV for 30-year-old males and females and no association between the experience of IPV and males\u2019 leaving their partner. These findings leads to a recommendation that gender-specific prevention efforts should put greater emphasis on males\u2019 IPV victimization and their decision to stay in an abusive relationship.The findings of this study have significant implications for IPV reduction programs: first, gender differences in predictors of IPV and in its association with leaving a partner raise the need for early IPV prevention. If it is possible to prevent first victimization experiences, then the subsequent victimization may be avoided [The finding that early IPV victimization remained a determining factor of revictimization highlights the need for  avoided . More imIPV interventions which protect and assist those affected by IPV, should address complex needs of survivors. For example, in the current study, depression was a significant predictor of both changing partner and IPV victimization. Clinical intervention efforts are required to target pre-existing as well as subsequent mental health problems of victims to minimize the risk of further abuse. Having a low income was also a significant barrier against abused females to leave an abusive partner. IPV interventions should therefore consider the policy of women\u2019s financial empowerment .This study has a number of limitations: The data were collected using a self-report measure from one partner, which may associated with self-serving bias or over-reporting negative behaviours of partners. In addition, at 21\u00a0years respondents reported their life-time IPV in either their current or previous relationships, while at the 30\u00a0year follow up, they described their most recent relationships during last 12\u00a0months . Males\u2019", "texts": ["This paper investigates gender differences in persistence of intimate partner violence (IPV), for those remaining or leaving an abusive relationship. We followed a sample of males and females to examine whether leaving an abusive partner may alter the continuity of victimization.Data were taken from the 21 and 30-year follow-ups of the Mater Hospital and University of Queensland Study of Pregnancy (MUSP) in Australia. A cohort of 1265 respondents, including 874 females and 391 males, completed a 21-item version of the Composite Abuse Scale.We found proportionally similar rates of IPV victimization for males and females at both the 21 and 30\u00a0year follow-ups. Females who reported they had an abusive partner at the 21\u00a0year follow-up were more likely to subsequently change their partner than did males. Harassment and then emotional abuse appeared to have a stronger association for females leaving a partner. For males, a reported history of IPV was not significantly associated with leaving the partner. There was no significant association between leaving (or not) a previous abusive relationship and later victimization, either for male or female respondents.Changing a partner does not interrupt the continuity of victimization either for male or female respondents, and previous IPV victimization remained a determining factor of re-abuse, despite re-partnering. Intimate partner violence (IPV) may occur repeatedly in the context of some intimate relationships . There iPrior research following those who have previously experienced IPV has been limited and inconclusive. Only a small number of scholars have suggested that changing a partner may reduce IPV perpetration , 8 and vlife course perspective suggests that particular periods of the life course may be associated with higher rates of IPV. Characteristics of early adulthood  contribute to a greater risk of IPV in this period. Afterwards, developmental changes  may protect individuals from subsequent victimization/ perpetration- regardless of leaving or staying with a partner victimization and staying in an abusive relationship, are related to the following factors: marital status, lower socio-economic status, presence of children, history of child abuse, and poor mental health , 39\u201343.what is your present marital status? Categories comprised single/never married, living together, married or separated. Education levels included high school or less, diploma and college and university. Having a child was dichotomized into yes and no. Participants were asked about their family income which was defined as gross income before tax. Then using the Australian National Poverty Line as a guide [low income and the rest into higher income. For measuring history of sexual child abuse 21-year respondents were asked whether they had experienced being pressured or forced to have sexual contact before they were 16\u00a0years. Depression was assessed using the Center for Epidemiologic Studies Depression Scale (CES-D) which is a widely-used self-report scale [during the last 12\u00a0months have your sexual partners been: only the opposite sex, only the same sex and both sexes. We then categorised respondents into two categories of heterosexual and homo/bisexual.All participants were about 21 and 30\u00a0years of age at each follow up, so we did not adjust for the age differences in the cohort. Marital status was measured by the question  a guide , we catert scale . It contrt scale , 47. Sexp-value<\u20090.05 for significance. In Table\u00a0In Table\u00a0Among 1265 21-year-old participants who were in a relationship, 6.1% were married and 93.9% were living together. 11.1% of respondents had children.p\u2009=\u20090.07) is experienced more often by females. By contrast, 21-year-old males more frequent report being physically abused. At 30, there are no gender differences in any form IPV.Table Table Table A further detailed analysis (data not shown) suggests that although the association between having children and females\u2019 leaving their partners is negative Table , when moTable p\u2009=\u20090.08). For females we note that 55.7% of those experiencing IPV changed partners, while 42.9% of those not experiencing IPV changed partners (p\u2009<\u2009\u00a00.001) by the 30\u00a0year follow up. Females who reported IPV at 21\u00a0years and remained with their partners, were no more likely to be abused at 30\u00a0years compared to females who had changed partners . A further interaction terms between the experience of IPV at 21 (non-abused/abused) as primary variable and change of partner (stay/change) as moderator was conducted to predict the experience of IPV at 30 (non-abused/abused) separately for females and males (data not shown in a table). Consistent with the findings in Fig. 95\u2009=\u20090.44\u20131.35). In contrast, the primary effect of experiencing IPV at 21 remains a robust significant predictor for experiencing IPV at 30\u00a0years. For males, no statistically significant difference in experiencing IPV at 30\u00a0years is observed between males who left their abusive or non-abusive partners . These findings were independent of a range of potential confounding factors.Figure\u00a0p\u2009<\u2009\u00a00.00 by the 3The current study has compared males and females in the continuity of IPV victimization at 21 and 30\u00a0years of age. A cohort of 1260 cases was followed to determine whether early IPV victimization was associated with leaving the prior partner and subsequent IPV. In addition, we followed both males and females to examine how a change of abusive partners may alter the continuity of victimization.p\u2009<\u2009\u00a00.0001). Despite this decline in the IPV rate across time, there was a robust significant association between early victimization and re-victimization for both males and females. We also found that a substantial proportion of females (55.7%) and males (51.0%) who report experiencing IPV at 21\u00a0years left their partners (p\u2009>\u20090.05). Victimized males at 21\u00a0years were no more likely to change partners, than those not experiencing IPV at 21\u00a0years. These findings were not affected by any of the sociodemographic factors that were considered. Harassment and then emotional abuse appeared to have a higher association with leaving partner in females. Relationship change did not appear to prevent males and females from the continued experience of victimization. We found experiencing IPV at 21 remains a robust significant predictor for experiencing IPV at 30\u00a0years, regardless of whether there is a change of partner.The results of this study suggest that rates of IPV victimization declined from 21 to the 30\u00a0year follow up . Features of this life course stage include instability  and tendency to postpone adults\u2019 responsibilities , which may contribute to a higher rate of IPV victimization at this period [The observed decline in IPV victimization from 21 to 30\u00a0years may reflect the longer period in which 21-year respondents were asked about their experiences, compared to that of 30\u00a0years (last year). Nevertheless, this finding is consistent with a s period , 12, 13.s period .A relationship between early and further victimization supports previous research which suggests that earlier victimization may be taken to mean violence is considered a normal aspect of intimate relationships. Prior experiences of family violence may lead to cumulative disadvantages  which negatively affect the nature of future relationships , 48\u201351.Slightly higher rates of leaving the abusive partner in females seems to be consistent with other research indicating that females have disproportionately higher rates of relationship termination than males . ConsideWe also found no support for the effectiveness of leaving an abusive partner. This finding is in line some previous studies which find no significant difference between those who stayed or changed partners , 15. HowA body of research has shown that earlier victimization may lead to long-lasting consequences for survivors like fear, posttraumatic stress, anxiety and disempowerment . SurvivoThis study has several strengths: IPV was assessed by a validated measure at 21 and 30\u00a0years. We also used the longitudinal data from a large prospective cohort of both males and females and adjusted for a range of confounding factors. We have found that leaving an abusive relationship makes no significant difference to experiencing further IPV and early IPV victimization remains the strongest predictor of re-abuse, despite changing partner. The current work has extended existing knowledge about IPV victimization experienced in relationships with different partners. Our findings raise the question of whether there are characteristics of those affected by IPV and socio-cultural factors, not measured in this study, that need to be identified and addressed if IPV and its consequences are to be reduced.gender specific IPV interventions. For example, we found similar rates of IPV for 30-year-old males and females and no association between the experience of IPV and males\u2019 leaving their partner. These findings leads to a recommendation that gender-specific prevention efforts should put greater emphasis on males\u2019 IPV victimization and their decision to stay in an abusive relationship.The findings of this study have significant implications for IPV reduction programs: first, gender differences in predictors of IPV and in its association with leaving a partner raise the need for early IPV prevention. If it is possible to prevent first victimization experiences, then the subsequent victimization may be avoided [The finding that early IPV victimization remained a determining factor of revictimization highlights the need for  avoided . More imIPV interventions which protect and assist those affected by IPV, should address complex needs of survivors. For example, in the current study, depression was a significant predictor of both changing partner and IPV victimization. Clinical intervention efforts are required to target pre-existing as well as subsequent mental health problems of victims to minimize the risk of further abuse. Having a low income was also a significant barrier against abused females to leave an abusive partner. IPV interventions should therefore consider the policy of women\u2019s financial empowerment .This study has a number of limitations: The data were collected using a self-report measure from one partner, which may associated with self-serving bias or over-reporting negative behaviours of partners. In addition, at 21\u00a0years respondents reported their life-time IPV in either their current or previous relationships, while at the 30\u00a0year follow up, they described their most recent relationships during last 12\u00a0months . Males\u2019"]}
{"representative": "Background: Although various types of intimate partner violence (IPV) tend to co-occur, risk factors of each type of IPV may differ. At the same time, most of the existing literature on risk factors of IPV among minorities has used a cross-sectional design and has focused on physical rather than sexual IPV. We conducted the current study to compare Black and Hispanic women for psychological predictors of change in sexual IPV over time. Methods: Using data from the Fragile Families and Child Wellbeing Study (FFCWS), this study followed 561 Black and 475 Hispanic women with their male partners for four years. Independent variables included male partners\u2019 depression, anxiety, problem alcohol use, and male-to-female physical and psychological IPV perpetration. The dependent variable was sexual IPV reported by female partners, measured at baseline, two years, and four years later. Covariates included age, income, marital status and education level. We used a multi-group latent growth curve model (LGCM) to explain intercept, linear, and quadratic slopes, which represent the baseline, and linear and curvilinear trajectories of male-to-female sexual IPV, where groups were defined based on ethnicity. Results: Psychological IPV was associated with sexual IPV at baseline among both ethnic groups. The male partner\u2019s depression was a risk factor for an increase in sexual IPV over time among Black but not Hispanic women. Anxiety, problem alcohol use and physical IPV did not have an effect on the baseline or change in sexual IPV over time. Psychological IPV was not associated with an increase in sexual IPV over time in either ethnic group. Conclusions: There is a need for screening of sexual IPV in the presence of psychological IPV among minority women. There is also a need for screening and treatment of male partners\u2019 depression as a strategy to reduce sexual IPV among Black women.Background: Although various types of intimate partner violence (IPV) tend to co-occur, risk factors of each type of IPV may differ. At the same time, most of the existing literature on risk factors of IPV among minorities has used a cross-sectional design and has focused on physical rather than sexual IPV. We conducted the current study to compare Black and Hispanic women for psychological predictors of change in sexual IPV over time. Methods: Using data from the Fragile Families and Child Wellbeing Study (FFCWS), this study followed 561 Black and 475 Hispanic women with their male partners for four years. Independent variables included male partners\u2019 depression, anxiety, problem alcohol use, and male-to-female physical and psychological IPV perpetration. The dependent variable was sexual IPV reported by female partners, measured at baseline, two years, and four years later. Covariates included age, income, marital status and education level. We used a multi-group latent growth curve model (LGCM) to explain intercept, linear, and quadratic slopes, which represent the baseline, and linear and curvilinear trajectories of male-to-female sexual IPV, where groups were defined based on ethnicity. Results: Psychological IPV was associated with sexual IPV at baseline among both ethnic groups. The male partner\u2019s depression was a risk factor for an increase in sexual IPV over time among Black but not Hispanic women. Anxiety, problem alcohol use and physical IPV did not have an effect on the baseline or change in sexual IPV over time. Psychological IPV was not associated with an increase in sexual IPV over time in either ethnic group. Conclusions: There is a need for screening of sexual IPV in the presence of psychological IPV among minority women. There is also a need for screening and treatment of male partners\u2019 depression as a strategy to reduce sexual IPV among Black women. Although both genders commit intimate partner violence (IPV) against their partners, male-to-female IPV is more common than female-to-male IPV . There aSexual IPV includes a wide range of experiences, from coercion to unwanted sexual activity by a partner to more severe forms, such as rape. Up to 21% of women experience sexual IPV . Women wBased on the literature, sexual, psychological, and physical IPV tend to co-occur ,12,13. TExposure to sexual coercion, threats of violence, and physical violence often co-occur in women . VictimsWhile research on the topic is limited, we have reason to believe that anxiety acts as a possible risk factor for perpetration of IPV ,29,30. VAlcohol misuse also increases the risk of IPV perpetration among men ,32,33,34Using a dyadic approach that includes both partners as informants , the curThis study used interview data from Waves 2 through 4 of the Fragile Families and Child Wellbeing Study (FFCWS), an ongoing longitudinal, population-based cohort, which began in 1998 ,41,42. TThe study was approved by Institutional Review Board Committees at Princeton University and Columbia University. Verbal and written informed consent was obtained from participants at each interview, and all participants were compensated for their involvement in the study.The FFCWS used a random sampling method from families in 20 U.S. cities with populations of 200,000 or more. A detailed description of sampling strategy and interview protocol in the FFCWS is available elsewhere . The FFCWe limited the current analysis to couples in which the female partner was either Black/African American or Latino/Hispanic. As a result, 1036 of 4898 total participating couples from different ethnic groups who completed the baseline of the study were entered into the current analysis.Data used here were limited to the parental core interviews, interviews with the mother and father reporting on child health and development, and their own romantic relationships with the other parent and marriage attitudes. The term \u201cparental core interview\u201d is used to distinguish interviews with parents from interviews with a primary caregiver, which may include caregivers other than parents . ParticiMale-to-female sexual IPV. Sexual IPV was assessed by asking female partners \u201cHow often does the father (of your baby) force you to have sex/do sexual things?\u201d Response items included never (0), sometimes (1), or often (2). This item was adapted from the Spouse Observation Checklist  and studMale-to-female physical IPV. Physical IPV was assessed by asking female partners two questions on a 3-point scale , regarding how often fathers carried out behaviors toward the female partner  and were adapted from the Conflict Tactics Scale (CTS-2) for adults ,56. The Major Depressive Disorder (MDD). The Composite International Diagnostic Interview-Short Form (CIDI-SF) was used to measure MDD . The CIDGeneralized Anxiety Disorder (GAD). The CIDI-SF was used to screen for symptoms consistent with a diagnosis of GAD . The diaProblem Alcohol Use. Heavy/problem alcohol use was defined as five or more drinks during a single day over the past month (coded \u201c1\u201d). This measure approximates heavy drinking according to the definition by the National Institute on Alcohol and Alcoholism, i.e., five or more drinks in a single day for men . Based on this model, MDD in male partner (at baseline) was associated with a larger linear slope for trajectory of sexual IPV during four years of follow up . Psychological IPV at time 2 was also associated with higher sexual IPV at time 2. Male partners\u2019 age, education level, income, ethnicity, GAD, problem alcohol use and physical IPV were not significantly associated with baseline, linear, or quadratic slopes of sexual IPV over time . Male partners\u2019 age, education level, income, ethnicity, MDD, GAD, problem alcohol use and physical IPV were not significantly associated with sexual IPV at wave 2 or linear or quadratic slopes of sexual IPV over time (Model 2 corresponds to Hispanic women and their partner /spouse. The model showed a good fit to the data [ver time .This study showed similarities and differences in psychological predictors of sexual IPV against Black and Hispanic women. A similar association between psychological and sexual IPV was found for both Black and Hispanic women. Male partners\u2019 depression was associated with a worse trajectory of sexual IPV over the follow-up period among Black, but not Hispanic women.We found ethnic variation in the effects of depression in male partner, meaning the effect was present in Blacks but not Hispanics. Ethnic variations in the associations between psychosocial risk factors and behavioral health outcomes are shown across domains ,62,63,64Our finding on the effect of male partner depression on sexual IPV is supported by literature that shows psychopathology increases the risk of IPV perpetration ,21. AngeOur study did not show that male partner\u2019 problem drinking behavior had any effect on sexual IPV victimization of Black or Hispanic female partners. In a study in Russia, the odds of IPV perpetration were three times greater among men who misused alcohol than those who did not . CommuniFurthermore, alcohol use disorder was reported as the strongest associated factor of IPV perpetration in a study conducted by Smith, Homish, Leonard, and Cornelius . CompareOur study did not find that male partners\u2019 presentation of GAD had any effect on sexual IPV against Black or Hispanic women. Again, most studies which have built our current understanding of the association between anxiety and IPV perpetration are limited to other types of IPV. In a study by Miga et al. , attachmOur study has four policy and clinical implications. First, as this was a community sample, rather than a clinical sample, and as minority populations have greater stigma and lower access to health care, there is a need for screening and treatment programs in the community. The first implication of our results is a need for community-based intervention to prevent of IPV in ethnically diverse communities.Second, we found that psychological and sexual IPV co-occur, regardless of ethnicity. This finding suggests a need for combined programs which can help protect women of minority status against experiences of IPV through preventative and treatment programs. Research findings on risk factors and protective factors contributing to co-occurring physical and sexual IPC may collectively contribute to reducing ethnic disparities in the burden on IPV among women.Third, based on our findings, there is a need to screen male perpetrators for mental health issues, and other types of IPV, particularly psychological IPV. This is an important distinction from prior approaches to identifying and addressing IPV, which have primarily focused on the screening of victims.  Our findAs stated, our research findings provide evidence for the importance of mental health screening of male perpetrators, in addition to female victims. A fourth implication of our study is, as psychological and sexual IPV victimization tend to co-occur among minority individuals, we propose combined programs that simultaneously address various types of IPV. Interventions aimed at the prevention of IPV may benefit from combined programs that target various forms of IPV, including sexual violence. We believe that prevention strategies may benefit from studies that focus on both of these outcomes.The current study had four significant limitations. Firstly, female victims may underreport sexual IPV, which is particularly significant for low SES and minority populations who may suffer from greater stigma in reporting. Low SES and minority status may reduce IPV disclosure ,89,90. SAdditional research is needed to understand why, how, and when women of diverse ethnic minority groups are exposed to a combination of psychological and sexual IPV. A suggested first step would be testing psychological IPV as a possible mediator for the effect of risk factors on sexual IPV. In addition, there is a need to test the efficacy of interventions meant to improve the mental health of male partners as a strategy to prevent male-to-female IPV. Future research should add clinical interviews and more contextual data along with standard measures .Black and Hispanic women showed common and unique psychological determinants of sexual IPV. Psychological IPV was similarly associated with sexual IPV among both ethnic groups. Male partners\u2019 depression was a risk factor for sexual IPV among Black but not Hispanic women. Combined programs that jointly screen for sexual and non-sexual IPV are needed among minority women, regardless of their ethnicity. There is also a need for attention to male partners\u2019 psychopathology in the presence of sexual IPV reported by Black women.", "texts": ["Background: Although various types of intimate partner violence (IPV) tend to co-occur, risk factors of each type of IPV may differ. At the same time, most of the existing literature on risk factors of IPV among minorities has used a cross-sectional design and has focused on physical rather than sexual IPV. We conducted the current study to compare Black and Hispanic women for psychological predictors of change in sexual IPV over time. Methods: Using data from the Fragile Families and Child Wellbeing Study (FFCWS), this study followed 561 Black and 475 Hispanic women with their male partners for four years. Independent variables included male partners\u2019 depression, anxiety, problem alcohol use, and male-to-female physical and psychological IPV perpetration. The dependent variable was sexual IPV reported by female partners, measured at baseline, two years, and four years later. Covariates included age, income, marital status and education level. We used a multi-group latent growth curve model (LGCM) to explain intercept, linear, and quadratic slopes, which represent the baseline, and linear and curvilinear trajectories of male-to-female sexual IPV, where groups were defined based on ethnicity. Results: Psychological IPV was associated with sexual IPV at baseline among both ethnic groups. The male partner\u2019s depression was a risk factor for an increase in sexual IPV over time among Black but not Hispanic women. Anxiety, problem alcohol use and physical IPV did not have an effect on the baseline or change in sexual IPV over time. Psychological IPV was not associated with an increase in sexual IPV over time in either ethnic group. Conclusions: There is a need for screening of sexual IPV in the presence of psychological IPV among minority women. There is also a need for screening and treatment of male partners\u2019 depression as a strategy to reduce sexual IPV among Black women.Background: Although various types of intimate partner violence (IPV) tend to co-occur, risk factors of each type of IPV may differ. At the same time, most of the existing literature on risk factors of IPV among minorities has used a cross-sectional design and has focused on physical rather than sexual IPV. We conducted the current study to compare Black and Hispanic women for psychological predictors of change in sexual IPV over time. Methods: Using data from the Fragile Families and Child Wellbeing Study (FFCWS), this study followed 561 Black and 475 Hispanic women with their male partners for four years. Independent variables included male partners\u2019 depression, anxiety, problem alcohol use, and male-to-female physical and psychological IPV perpetration. The dependent variable was sexual IPV reported by female partners, measured at baseline, two years, and four years later. Covariates included age, income, marital status and education level. We used a multi-group latent growth curve model (LGCM) to explain intercept, linear, and quadratic slopes, which represent the baseline, and linear and curvilinear trajectories of male-to-female sexual IPV, where groups were defined based on ethnicity. Results: Psychological IPV was associated with sexual IPV at baseline among both ethnic groups. The male partner\u2019s depression was a risk factor for an increase in sexual IPV over time among Black but not Hispanic women. Anxiety, problem alcohol use and physical IPV did not have an effect on the baseline or change in sexual IPV over time. Psychological IPV was not associated with an increase in sexual IPV over time in either ethnic group. Conclusions: There is a need for screening of sexual IPV in the presence of psychological IPV among minority women. There is also a need for screening and treatment of male partners\u2019 depression as a strategy to reduce sexual IPV among Black women. Although both genders commit intimate partner violence (IPV) against their partners, male-to-female IPV is more common than female-to-male IPV . There aSexual IPV includes a wide range of experiences, from coercion to unwanted sexual activity by a partner to more severe forms, such as rape. Up to 21% of women experience sexual IPV . Women wBased on the literature, sexual, psychological, and physical IPV tend to co-occur ,12,13. TExposure to sexual coercion, threats of violence, and physical violence often co-occur in women . VictimsWhile research on the topic is limited, we have reason to believe that anxiety acts as a possible risk factor for perpetration of IPV ,29,30. VAlcohol misuse also increases the risk of IPV perpetration among men ,32,33,34Using a dyadic approach that includes both partners as informants , the curThis study used interview data from Waves 2 through 4 of the Fragile Families and Child Wellbeing Study (FFCWS), an ongoing longitudinal, population-based cohort, which began in 1998 ,41,42. TThe study was approved by Institutional Review Board Committees at Princeton University and Columbia University. Verbal and written informed consent was obtained from participants at each interview, and all participants were compensated for their involvement in the study.The FFCWS used a random sampling method from families in 20 U.S. cities with populations of 200,000 or more. A detailed description of sampling strategy and interview protocol in the FFCWS is available elsewhere . The FFCWe limited the current analysis to couples in which the female partner was either Black/African American or Latino/Hispanic. As a result, 1036 of 4898 total participating couples from different ethnic groups who completed the baseline of the study were entered into the current analysis.Data used here were limited to the parental core interviews, interviews with the mother and father reporting on child health and development, and their own romantic relationships with the other parent and marriage attitudes. The term \u201cparental core interview\u201d is used to distinguish interviews with parents from interviews with a primary caregiver, which may include caregivers other than parents . ParticiMale-to-female sexual IPV. Sexual IPV was assessed by asking female partners \u201cHow often does the father (of your baby) force you to have sex/do sexual things?\u201d Response items included never (0), sometimes (1), or often (2). This item was adapted from the Spouse Observation Checklist  and studMale-to-female physical IPV. Physical IPV was assessed by asking female partners two questions on a 3-point scale , regarding how often fathers carried out behaviors toward the female partner  and were adapted from the Conflict Tactics Scale (CTS-2) for adults ,56. The Major Depressive Disorder (MDD). The Composite International Diagnostic Interview-Short Form (CIDI-SF) was used to measure MDD . The CIDGeneralized Anxiety Disorder (GAD). The CIDI-SF was used to screen for symptoms consistent with a diagnosis of GAD . The diaProblem Alcohol Use. Heavy/problem alcohol use was defined as five or more drinks during a single day over the past month (coded \u201c1\u201d). This measure approximates heavy drinking according to the definition by the National Institute on Alcohol and Alcoholism, i.e., five or more drinks in a single day for men . Based on this model, MDD in male partner (at baseline) was associated with a larger linear slope for trajectory of sexual IPV during four years of follow up . Psychological IPV at time 2 was also associated with higher sexual IPV at time 2. Male partners\u2019 age, education level, income, ethnicity, GAD, problem alcohol use and physical IPV were not significantly associated with baseline, linear, or quadratic slopes of sexual IPV over time . Male partners\u2019 age, education level, income, ethnicity, MDD, GAD, problem alcohol use and physical IPV were not significantly associated with sexual IPV at wave 2 or linear or quadratic slopes of sexual IPV over time (Model 2 corresponds to Hispanic women and their partner /spouse. The model showed a good fit to the data [ver time .This study showed similarities and differences in psychological predictors of sexual IPV against Black and Hispanic women. A similar association between psychological and sexual IPV was found for both Black and Hispanic women. Male partners\u2019 depression was associated with a worse trajectory of sexual IPV over the follow-up period among Black, but not Hispanic women.We found ethnic variation in the effects of depression in male partner, meaning the effect was present in Blacks but not Hispanics. Ethnic variations in the associations between psychosocial risk factors and behavioral health outcomes are shown across domains ,62,63,64Our finding on the effect of male partner depression on sexual IPV is supported by literature that shows psychopathology increases the risk of IPV perpetration ,21. AngeOur study did not show that male partner\u2019 problem drinking behavior had any effect on sexual IPV victimization of Black or Hispanic female partners. In a study in Russia, the odds of IPV perpetration were three times greater among men who misused alcohol than those who did not . CommuniFurthermore, alcohol use disorder was reported as the strongest associated factor of IPV perpetration in a study conducted by Smith, Homish, Leonard, and Cornelius . CompareOur study did not find that male partners\u2019 presentation of GAD had any effect on sexual IPV against Black or Hispanic women. Again, most studies which have built our current understanding of the association between anxiety and IPV perpetration are limited to other types of IPV. In a study by Miga et al. , attachmOur study has four policy and clinical implications. First, as this was a community sample, rather than a clinical sample, and as minority populations have greater stigma and lower access to health care, there is a need for screening and treatment programs in the community. The first implication of our results is a need for community-based intervention to prevent of IPV in ethnically diverse communities.Second, we found that psychological and sexual IPV co-occur, regardless of ethnicity. This finding suggests a need for combined programs which can help protect women of minority status against experiences of IPV through preventative and treatment programs. Research findings on risk factors and protective factors contributing to co-occurring physical and sexual IPC may collectively contribute to reducing ethnic disparities in the burden on IPV among women.Third, based on our findings, there is a need to screen male perpetrators for mental health issues, and other types of IPV, particularly psychological IPV. This is an important distinction from prior approaches to identifying and addressing IPV, which have primarily focused on the screening of victims.  Our findAs stated, our research findings provide evidence for the importance of mental health screening of male perpetrators, in addition to female victims. A fourth implication of our study is, as psychological and sexual IPV victimization tend to co-occur among minority individuals, we propose combined programs that simultaneously address various types of IPV. Interventions aimed at the prevention of IPV may benefit from combined programs that target various forms of IPV, including sexual violence. We believe that prevention strategies may benefit from studies that focus on both of these outcomes.The current study had four significant limitations. Firstly, female victims may underreport sexual IPV, which is particularly significant for low SES and minority populations who may suffer from greater stigma in reporting. Low SES and minority status may reduce IPV disclosure ,89,90. SAdditional research is needed to understand why, how, and when women of diverse ethnic minority groups are exposed to a combination of psychological and sexual IPV. A suggested first step would be testing psychological IPV as a possible mediator for the effect of risk factors on sexual IPV. In addition, there is a need to test the efficacy of interventions meant to improve the mental health of male partners as a strategy to prevent male-to-female IPV. Future research should add clinical interviews and more contextual data along with standard measures .Black and Hispanic women showed common and unique psychological determinants of sexual IPV. Psychological IPV was similarly associated with sexual IPV among both ethnic groups. Male partners\u2019 depression was a risk factor for sexual IPV among Black but not Hispanic women. Combined programs that jointly screen for sexual and non-sexual IPV are needed among minority women, regardless of their ethnicity. There is also a need for attention to male partners\u2019 psychopathology in the presence of sexual IPV reported by Black women."]}
{"representative": "Understanding the past-year prevalence of male-perpetrated intimate partner violence (IPV) and risk factors is essential for building evidence-based prevention and monitoring progress to Sustainable Development Goal (SDG) 5.2, but so far, population-based research on this remains very limited. The objective of this study is to compare the population prevalence rates of past-year male-perpetrated IPV and nonpartner rape from women\u2019s and men\u2019s reports across 4 countries in Asia and the Pacific. A further objective is to describe the risk factors associated with women\u2019s experience of past-year physical or sexual IPV from women\u2019s reports and factors driving women\u2019s past-year experience of partner violence.This paper presents findings from the United Nations Multi-country Study on Men and Violence in Asia and the Pacific. In the course of this study, in population-based cross-sectional surveys, 5,206 men and 3,106 women aged 18\u201349 years were interviewed from 4 countries: Cambodia, China, Papua New Guinea (PNG), and Sri Lanka. To measure risk factors, we use logistic regression and structural equation modelling to show pathways and mediators. The analysis was not based on a written plan, and following a reviewer\u2019s comments, some material was moved to supplementary files and the regression was performed without variable elimination. Men reported more lifetime perpetration of IPV  than women did experience , but women\u2019s reports of past-year experience  were not very clearly different from men\u2019s . Women reported much more emotional/economic abuse (past-year ranges 1.4%\u20135.7% for men and 4.1%\u201327.7% for women). Reports of nonpartner rape were similar for men (range 0.8%\u20131.9% in the past year) and women (range 0.4%\u20132.3% in past year), except in Bougainville, where they were higher for men (11.7% versus 5.7%). The risk factor modelling shows 4 groups of variables to be important in experience of past-year sexual and/or physical IPV: (1) poverty, (2) all childhood trauma, (3) quarrelling and women\u2019s limited control in relationships, and (4) partner factors . The population attributable fraction (PAF) was largest for quarrelling often, but the second greatest PAF was for the group related to exposure to violence in childhood. The relationship control variable group had the third highest PAF, followed by other partner factors. Currently married women were also more at risk. In the structural model, a resilience pathway showed less poverty, higher education, and more gender-equitable ideas were connected and conveyed protection from IPV. These are all amenable risk factors. This research was cross-sectional, so we cannot be sure of the temporal sequence of exposure, but the outcome being a past-year measure to some extent mitigates this problem.Past-year IPV indicators based on women\u2019s reported experience that were developed to track SDG 5 are probably reasonably reliable but will not always give the same prevalence as may be reported by men. Report validity requires further research. Interviews with men to track past-year nonpartner rape perpetration are feasible and important. The findings suggest a range of factors are associated with past-year physical and/or sexual IPV exposure; of particular interest is the resilience pathway suggested by the structural model, which is highly amenable to intervention and explains why combining economic empowerment of women and gender empowerment/relationship skills training has been successful. This study provides additional rationale for scaling up violence prevention interventions that combine economic and gender empowerment/relationship skills building of women, as well as the value of investing in girls\u2019 education with a view to long-term violence reduction. In a cross-sectional analysis of survey data from Cambodia, China, Papua New Guinea, and Sri Lanka, Rachel Jewkes and colleagues compare women's and men's reports of past-year prevalence of intimate partner violence and rape. Understanding the past-year prevalence of physical and or sexual intimate partner violence (IPV) and risk factors is essential for building evidence-based prevention.Previous studies have not compared men\u2019s and women\u2019s past-year prevalence reports and have been limited by a predominant focus on risk factors for lifetime exposure to IPV.Monitoring SDG 5.2 and building evidence-based prevention require a relative understanding of the measures of past-year prevalence and the drivers of this violence.We use data from 4 countries of the UN Multi-country Study on Men and Violence in Asia and the Pacific to compare the population prevalence rates of past-year IPV and nonpartner rape from women\u2019s and men\u2019s reports and present an analysis of drivers of women\u2019s experience of past-year physical or sexual IPV.Women\u2019s reports of past-year male-perpetrated IPV were similar to those from men.Four groups of variables are important drivers of IPV: poverty, all childhood trauma, quarrelling and women\u2019s limited control in the relationship, and partner factors .Past-year IPV indicators based on women\u2019s reported experience that were developed to track SDG 5 are probably reasonably reliable.Women appear to gain resilience to violence through combined economic power and understanding gender empowerment/relationship skills, as well as education; this is an important foundation for intervention.Further research is needed on the validity of men\u2019s and women\u2019s reports of IPV, which could not be determined from these data. In 2015, eliminating all forms of violence against women and girls (VAWG) was adopted as a target for the Sustainable Development Goal (SDG) 5 on gender equality and empowerment of women. To achieve this, we must develop and roll out effective measures to prevent male-perpetrated violence and show their effect. The indicators of progress towards this target are not finalized but will be a measure of women\u2019s experience of intimate partner violence (IPV) and of nonpartner sexual violence in the past 12 months. According to most recent estimates, 30% of women aged 15 years and over have experienced male-perpetrated physical and/or sexual IPV, and 7% nonpartner sexual violence, in their lifetime [In low- and middle-income countries, the World Health Organization instrument that was developed for its Multi-country Study on Women\u2019s Health and Domestic Violence against Women is generally seen as the gold standard measure for women. Parallel research with men has developed a methodology for measuring perpetration, but the 2 measures of violence in heterosexual relationships have not been compared. Given that widely used indicators will most likely focus on reports of just 1 gender for reasons of resource constraints, it is important that there be an understanding of the comparability of men\u2019s and women\u2019s reports. Without this, we have uncertainty about the validity of women\u2019s reports of experiences of IPV and nonpartner sexual violence. There is particular concern that sexual violence may be under-reported by women because rape is highly stigmatized, which may result in minimization of events, but it is also possible men might under-report perpetration of violence so as not to incriminate themselves ,4.Prevention of VAWG needs to be built on evidence of drivers among women currently at risk (as well as those of perpetration). There is a reasonably large amount of literature on risk factors for experience of IPV , but maThe UN Multi-country Study on Men and Violence was designed to address many of the gaps in previous data sources . It has Ethical approval was provided by the Medical Research Council of South Africa; the College of Humanities, Beijing Forestry University; National Ethics Committee for Health Research of Cambodia; and the Faculty of Medicine at the University of Colombo, Sri Lanka.The survey was developed by Partners for Prevention in collaboration with the Medical Research Council of South Africa and the country research teams. Research was conducted in 2011\u20132012. Of the 6 country surveys, only 4 had male and female interviews: China, Cambodia, Bougainville in Papua New Guinea, and Sri Lanka. The present study is intended to contrast women's reported experience of IPV and nonpartner rape with men's reported perpetration of IPV and nonpartner rape; therefore, our analysis focuses on these 4 surveys. The sample from Cambodia and the sample from Papua New Guinea were representative, respectively, of Cambodia and the island of Bougainville. The Chinese site was a county with a town and rural area, and in Sri Lanka, Colombo and 3 contrasting districts were surveyed. Further details of the research can be found elsewhere ,10.In each setting, we selected census enumeration areas, with a probability proportionate to size, and systematically selected households within these areas. In households, we invited a man or woman (depending on the cluster) aged 18\u201349 years  for interview, with a trained sex-matched interviewer. Most interviews were face to face, but for men, answers to most sensitive questions were self-completed on audio-enhanced personal digital assistants (APDAs). In China, a household list of individuals in each cluster by age and sex was available and used for sampling within selected clusters, and the entire questionnaire was self-completed. Full details of the methods, sampling, and response rates are presented elsewhere . We condThe data analysis was largely planned at the point of commencement of the work on the paper. Authors EF and RJ were involved in the research from its inception and had planned the questionnaire so that it would be possible to undertake an analysis of prevalence of violence and risk factors. They ensured as much as possible that the main variables previously described in the literature  were incWe combined the datasets and analysed the data using Stata, version 13. All procedures took into account the multistage structure of the dataset, with stratification by site within a country and enumeration areas as clusters. The sample was self-weighting. Women\u2019s experiences of violence and male partner violence perpetration, as well as the independent variables, were summarized as percentages (or means), with 95% confidence limits calculated using standard methods (Taylor linearization).We categorised the type of violence exposure according to the most severe type experienced, where greatest severity was considered as exposure to physical and/or sexual IPV, as this is the category that has been the basis of most health consequences research  and is cThe multiple emotional/economic abuse category consisted of women who had experienced more than 1 act of economic or emotional abuse but never experienced sexual or physical abuse. All ever-partnered women and men were classified into 5 violence exposure categories: none, emotional/economic without sexual or physical , sexual without physical and with or without emotional/economic , physical without sexual and with or without emotional/economic , or sexual and physical with or without emotional/economic .We also evaluated the relationship between the outcome (IPV) and nonresponse (missing data) in putative risk factors. No association was found between a woman\u2019s IPV status and her nonresponse to any of the possible risk factors. However, to increase the sample of women with responses to scale measurements , women with partial responses to scale items were also included. Three methods for imputing for missing data were initially compared. These involved imputing for missing scale items using either (1) a woman\u2019s responses to other items in the scale  or (2) the average for each item adjusted for IPV status, or (3) the average of the overall score adjusted for IPV status. There were no significant differences in the 3 methods for both gender attitudes and relationship control scores. We used \u2018the average of the overall score (adjusted for IPV status)\u2019 to impute for missing scores.The exercise of testing variables and building model drew on current theories about risk factors and drivers of violence against women. The selection of variables as putative risk factors was informed by the state of knowledge in the field. Drawing on a life-course modified ecological model of violence risk , we concTo show associations between independent variables that were putative risk factors, we first conducted a bivariable analysis with a (by type) lifetime IPV exposure measure and a multinomial regression with no physical, sexual, or severe economic/financial violence as the comparison group. A maximum likelihood multinomial logit model, which adjusted for the survey design, was used to compare factors associated with different types of IPV experienced with the no-violence reference category. We initially fitted bivariable models and then included all factors that were significantly associated with IPV experience in the bivariate models into an overall model, which was adjusted for the country and age group of the woman.We examined factors associated with past-year experience of IPV considering the same independent variables, but with a past-year exposure to any physical and/or sexual IPV as the outcome, due to sample size considerations, we did not perform multinomial modelling. We sought to model 19 covariates in the logistic regression model, which, according to generally accepted rules of thumb , would rP < or = 0.05 in the model, which is adjusted for country/site and age-group of the woman.Multivariable logistic regression was used to determine risk factors associated with past-year physical and/or sexual IPV experience in women, with those not experiencing this as the reference group. To enable the use of a variable on frequency of quarrelling, which was not measured in Cambodia, a dummy level for Cambodia was created for the quarrelling variable for use in the logistic regression model. All variables were included in the multivariate analysis. We focus the discussion on variables with The population attributable fractions (PAFs) for each category of IPV were calculated using the formula PAF = ((RRR \u2212 1) / RRR) * Pe, where RRR is the adjusted relative risk ratio from the adjusted model and Pe is the proportion of women who had experienced that particular IPV type and who had the exposure.Structural equation modelling (SEM) was conducted using Stata 13.0 to assess the interrelationship between variables associated with physical and/or sexual IPV in the multinomial regression model. The model outcome was a past-year IPV variable that had 4 levels drawn from the physical and sexual IPV questions: no exposure, sexual IPV, physical IPV, and physical or sexual IPV. The correlation between each hypothesized variable and the IPV variable was then tested by building variable pairs. All associations were tested by running a full-information maximum likelihood method to deal with missing values. This method was chosen over multiple imputations because it has been shown to yield superior results in structural equation modelling . As a neP < 0.05 level) from the exogenous variables to IPV in order to ensure model parsimony. Before adjusting standard errors for clustering of participants in countries, model fit was very good (p(\u03c72) = 0.519, RMSEA < 0.001, CFI = 1.000, and TLI = 1.001). After adjusting for clustering, the coefficient of determination (CD) was 0.215. The model did not include any error covariances.We fitted a path model using full information maximum likelihood (FIML) estimation to model all available data. The final model was built based on theory and statistically meaningful modifications using backwards elimination to exclude endogenous variables that did not mediate any path  were ever-partnered. Of the ever-partnered women, 90 (3.3%) did not respond to any of the questions related to IPV experience and were thus excluded from analysis. In total, 5,206 men were interviewed in the 4 countries, and 4,360 (83.8%) had ever been partnered. Four thousand and fifteen men completed the IPV questions, and 5,062 completed the non-partner rape questions.Comparing lifetime reports of women\u2019s experiences and men\u2019s reports of IPV by type from the 4 countries  reveals In Cambodia, 0.4% (95% CI 0.1%\u20131.73%) of women had experienced nonpartner rape in the past year, and 1.9% (95% CI 1.12%\u20132.70%) of men disclosed perpetration. In China, 2.3% (95% CI 1.49%\u20133.43%) of women had experienced nonpartner rape in the past year, and 1.7% (95% CI 0.94%\u20132.52%) of men disclosed perpetration. In Bougainville, 5.7% (95% CI 4.21%\u20137.75%) of women had experienced nonpartner rape in the past year, and 11.7% (95% CI 9.02%\u201314.30%) of men disclosed perpetration. In Sri Lanka, 0.5% (95% CI 0.15%\u20131.40%) of women had experienced nonpartner rape in the past year, and 0.8% (95% CI 0.22%\u20131.43%) of men disclosed perpetration.P < 0.001) as those in which the husband provided, another provided, or both the husband and wife shared equally in providing.The prevalence of past-year physical and/or sexual IPV experience increased with age . PovertyAll 3 forms of childhood abuse  and witnessing abuse of mother were more common among women with past-year physical or sexual IPV experience. Women whose partners earned more than them had a lower past-year IPV prevalence than those earning the same as their partners or women who earned more. Partner characteristics associated with women\u2019s past-year IPV experience were the male partner\u2019s regular alcohol use, ever or past-year drug use, lack of fidelity, and unemployment. Women who were highly controlled by their partner were more likely to have experienced past-year IPV, as were those who quarrelled more often and those holding less gender-inequitable views.Results for the structural equation model are presented in Between a quarter and two-thirds of women in the 4 countries studied had experienced IPV, and 1.7% and 15.9% had experienced nonpartner rape. There was very great diversity in the prevalence of IPV between countries, as previously reported in Asia and the Pacific [We would not necessarily expect men\u2019s and women\u2019s reports of nonpartner sexual violence to concur, and some women are at much higher risk than others in the population and may experience multiple rapes . AlthougWe saw 4 important groups of risk factors for IPV experience. First, our results confirm that past-year IPV victimisation is more common in a context of poverty . SecondlWitnessing abuse of one\u2019s mother has been found to be associated with both experience of and perpetration of IPV in many studies ,28\u201335. WThe third variable group consists of partner characteristics: his drinking, past-year drug use, controlling behaviour, unemployment, and fidelity. Generally, these are previously well-established risk factors, although research with men has not confirmed associations with drug use in Asia and the Pacific, except in relation to perpetration of multiple perpetrator rape ,10. AlcoThe frequency of quarrelling was very strongly associated with IPV, as it was in the models of men\u2019s perpetration in the 4 countries . AlthougOne of the most important findings of the structural model was a pathway that can be interpreted as indicating variables that build women\u2019s resilience to violence. This linked higher wealth, higher educational attainment, and having more gender-equitable attitudes. This is very important because all of these factors are amenable to intervention, and it highlights the role of poverty reduction and interventions to enhance girls\u2019 schooling, which may be supported for many reasons related to development and the general upliftment of women, in IPV prevention. In this study, the Gender Equitable Men (GEM) scale was used to measure women\u2019s gender attitudes. This is a broad measure that includes attitudes towards the use of violence against women. The latter alone have been shown to be very strongly associated with risk of violence ,42; howeEconomic empowerment has been shown to be a fruitful area of intervention with women , but morReducing childhood trauma exposure is ultimately critical to reducing women\u2019s experience of violence and is strongly related to poverty. Whilst there is much work on early interventions in childhood to reduce the experience of trauma and IPV in the next generation, it is possible that poverty reduction will have the greatest impact.The study findings reflect the sampled sites; generalizability beyond this is unclear, and the combined dataset analysed here does not reflect the whole region. Since the research was cross-sectional, temporality may be questioned, but since this was recent violence, this is not likely to be a great problem. All the prevalence estimates for violence were compared with estimates weighted for the number of eligible men and women per household. The latter were not significantly different in any site, and thus, we have used unweighted estimates. The main analysis was on past-year IPV exposure, and because this is less common than lifetime exposure, the power of the analysis was inevitably impacted. However, the focus has strengthened the interpretability of the results for programming, as it is the goal of IPV prevention to reduce exposure of women at risk in the future and recent abuse is the best measure of this. A study limitation is that we do not have a comparison of men\u2019s and women's reports from the same relationship. In accordance with WHO ethics and safety guidelines, we did not interview men and women in the same location, much less in couples. The motivation is to avoid the  possibility of retaliatory violence associated with partners learning of the interview content. This risk is not justified in cross-sectional research but prevents comparison of couples\u2019 reports.Our findings suggest that newly emphasised past-year IPV indicators that were developed to track SDG 5 would be reasonably reliable if based on women\u2019s interviews. Interviews with men to track past-year nonpartner rape perpetration are important. We have shown an important IPV resilience pathway. This helps us to understand why interventions that combine women\u2019s economic empowerment and building gender-equitable attitudes (and communication skills), such as Pronyk and colleagues\u2019 Image , may be S1 Fig(TIF)Click here for additional data file.S1 STROBE ChecklistChecklist of items that should be included in reports of cross-sectional studies.(DOC)Click here for additional data file.S1 Table(DOCX)Click here for additional data file.S2 Table(DOCX)Click here for additional data file.", "texts": ["Understanding the past-year prevalence of male-perpetrated intimate partner violence (IPV) and risk factors is essential for building evidence-based prevention and monitoring progress to Sustainable Development Goal (SDG) 5.2, but so far, population-based research on this remains very limited. The objective of this study is to compare the population prevalence rates of past-year male-perpetrated IPV and nonpartner rape from women\u2019s and men\u2019s reports across 4 countries in Asia and the Pacific. A further objective is to describe the risk factors associated with women\u2019s experience of past-year physical or sexual IPV from women\u2019s reports and factors driving women\u2019s past-year experience of partner violence.This paper presents findings from the United Nations Multi-country Study on Men and Violence in Asia and the Pacific. In the course of this study, in population-based cross-sectional surveys, 5,206 men and 3,106 women aged 18\u201349 years were interviewed from 4 countries: Cambodia, China, Papua New Guinea (PNG), and Sri Lanka. To measure risk factors, we use logistic regression and structural equation modelling to show pathways and mediators. The analysis was not based on a written plan, and following a reviewer\u2019s comments, some material was moved to supplementary files and the regression was performed without variable elimination. Men reported more lifetime perpetration of IPV  than women did experience , but women\u2019s reports of past-year experience  were not very clearly different from men\u2019s . Women reported much more emotional/economic abuse (past-year ranges 1.4%\u20135.7% for men and 4.1%\u201327.7% for women). Reports of nonpartner rape were similar for men (range 0.8%\u20131.9% in the past year) and women (range 0.4%\u20132.3% in past year), except in Bougainville, where they were higher for men (11.7% versus 5.7%). The risk factor modelling shows 4 groups of variables to be important in experience of past-year sexual and/or physical IPV: (1) poverty, (2) all childhood trauma, (3) quarrelling and women\u2019s limited control in relationships, and (4) partner factors . The population attributable fraction (PAF) was largest for quarrelling often, but the second greatest PAF was for the group related to exposure to violence in childhood. The relationship control variable group had the third highest PAF, followed by other partner factors. Currently married women were also more at risk. In the structural model, a resilience pathway showed less poverty, higher education, and more gender-equitable ideas were connected and conveyed protection from IPV. These are all amenable risk factors. This research was cross-sectional, so we cannot be sure of the temporal sequence of exposure, but the outcome being a past-year measure to some extent mitigates this problem.Past-year IPV indicators based on women\u2019s reported experience that were developed to track SDG 5 are probably reasonably reliable but will not always give the same prevalence as may be reported by men. Report validity requires further research. Interviews with men to track past-year nonpartner rape perpetration are feasible and important. The findings suggest a range of factors are associated with past-year physical and/or sexual IPV exposure; of particular interest is the resilience pathway suggested by the structural model, which is highly amenable to intervention and explains why combining economic empowerment of women and gender empowerment/relationship skills training has been successful. This study provides additional rationale for scaling up violence prevention interventions that combine economic and gender empowerment/relationship skills building of women, as well as the value of investing in girls\u2019 education with a view to long-term violence reduction. In a cross-sectional analysis of survey data from Cambodia, China, Papua New Guinea, and Sri Lanka, Rachel Jewkes and colleagues compare women's and men's reports of past-year prevalence of intimate partner violence and rape. Understanding the past-year prevalence of physical and or sexual intimate partner violence (IPV) and risk factors is essential for building evidence-based prevention.Previous studies have not compared men\u2019s and women\u2019s past-year prevalence reports and have been limited by a predominant focus on risk factors for lifetime exposure to IPV.Monitoring SDG 5.2 and building evidence-based prevention require a relative understanding of the measures of past-year prevalence and the drivers of this violence.We use data from 4 countries of the UN Multi-country Study on Men and Violence in Asia and the Pacific to compare the population prevalence rates of past-year IPV and nonpartner rape from women\u2019s and men\u2019s reports and present an analysis of drivers of women\u2019s experience of past-year physical or sexual IPV.Women\u2019s reports of past-year male-perpetrated IPV were similar to those from men.Four groups of variables are important drivers of IPV: poverty, all childhood trauma, quarrelling and women\u2019s limited control in the relationship, and partner factors .Past-year IPV indicators based on women\u2019s reported experience that were developed to track SDG 5 are probably reasonably reliable.Women appear to gain resilience to violence through combined economic power and understanding gender empowerment/relationship skills, as well as education; this is an important foundation for intervention.Further research is needed on the validity of men\u2019s and women\u2019s reports of IPV, which could not be determined from these data. In 2015, eliminating all forms of violence against women and girls (VAWG) was adopted as a target for the Sustainable Development Goal (SDG) 5 on gender equality and empowerment of women. To achieve this, we must develop and roll out effective measures to prevent male-perpetrated violence and show their effect. The indicators of progress towards this target are not finalized but will be a measure of women\u2019s experience of intimate partner violence (IPV) and of nonpartner sexual violence in the past 12 months. According to most recent estimates, 30% of women aged 15 years and over have experienced male-perpetrated physical and/or sexual IPV, and 7% nonpartner sexual violence, in their lifetime [In low- and middle-income countries, the World Health Organization instrument that was developed for its Multi-country Study on Women\u2019s Health and Domestic Violence against Women is generally seen as the gold standard measure for women. Parallel research with men has developed a methodology for measuring perpetration, but the 2 measures of violence in heterosexual relationships have not been compared. Given that widely used indicators will most likely focus on reports of just 1 gender for reasons of resource constraints, it is important that there be an understanding of the comparability of men\u2019s and women\u2019s reports. Without this, we have uncertainty about the validity of women\u2019s reports of experiences of IPV and nonpartner sexual violence. There is particular concern that sexual violence may be under-reported by women because rape is highly stigmatized, which may result in minimization of events, but it is also possible men might under-report perpetration of violence so as not to incriminate themselves ,4.Prevention of VAWG needs to be built on evidence of drivers among women currently at risk (as well as those of perpetration). There is a reasonably large amount of literature on risk factors for experience of IPV , but maThe UN Multi-country Study on Men and Violence was designed to address many of the gaps in previous data sources . It has Ethical approval was provided by the Medical Research Council of South Africa; the College of Humanities, Beijing Forestry University; National Ethics Committee for Health Research of Cambodia; and the Faculty of Medicine at the University of Colombo, Sri Lanka.The survey was developed by Partners for Prevention in collaboration with the Medical Research Council of South Africa and the country research teams. Research was conducted in 2011\u20132012. Of the 6 country surveys, only 4 had male and female interviews: China, Cambodia, Bougainville in Papua New Guinea, and Sri Lanka. The present study is intended to contrast women's reported experience of IPV and nonpartner rape with men's reported perpetration of IPV and nonpartner rape; therefore, our analysis focuses on these 4 surveys. The sample from Cambodia and the sample from Papua New Guinea were representative, respectively, of Cambodia and the island of Bougainville. The Chinese site was a county with a town and rural area, and in Sri Lanka, Colombo and 3 contrasting districts were surveyed. Further details of the research can be found elsewhere ,10.In each setting, we selected census enumeration areas, with a probability proportionate to size, and systematically selected households within these areas. In households, we invited a man or woman (depending on the cluster) aged 18\u201349 years  for interview, with a trained sex-matched interviewer. Most interviews were face to face, but for men, answers to most sensitive questions were self-completed on audio-enhanced personal digital assistants (APDAs). In China, a household list of individuals in each cluster by age and sex was available and used for sampling within selected clusters, and the entire questionnaire was self-completed. Full details of the methods, sampling, and response rates are presented elsewhere . We condThe data analysis was largely planned at the point of commencement of the work on the paper. Authors EF and RJ were involved in the research from its inception and had planned the questionnaire so that it would be possible to undertake an analysis of prevalence of violence and risk factors. They ensured as much as possible that the main variables previously described in the literature  were incWe combined the datasets and analysed the data using Stata, version 13. All procedures took into account the multistage structure of the dataset, with stratification by site within a country and enumeration areas as clusters. The sample was self-weighting. Women\u2019s experiences of violence and male partner violence perpetration, as well as the independent variables, were summarized as percentages (or means), with 95% confidence limits calculated using standard methods (Taylor linearization).We categorised the type of violence exposure according to the most severe type experienced, where greatest severity was considered as exposure to physical and/or sexual IPV, as this is the category that has been the basis of most health consequences research  and is cThe multiple emotional/economic abuse category consisted of women who had experienced more than 1 act of economic or emotional abuse but never experienced sexual or physical abuse. All ever-partnered women and men were classified into 5 violence exposure categories: none, emotional/economic without sexual or physical , sexual without physical and with or without emotional/economic , physical without sexual and with or without emotional/economic , or sexual and physical with or without emotional/economic .We also evaluated the relationship between the outcome (IPV) and nonresponse (missing data) in putative risk factors. No association was found between a woman\u2019s IPV status and her nonresponse to any of the possible risk factors. However, to increase the sample of women with responses to scale measurements , women with partial responses to scale items were also included. Three methods for imputing for missing data were initially compared. These involved imputing for missing scale items using either (1) a woman\u2019s responses to other items in the scale  or (2) the average for each item adjusted for IPV status, or (3) the average of the overall score adjusted for IPV status. There were no significant differences in the 3 methods for both gender attitudes and relationship control scores. We used \u2018the average of the overall score (adjusted for IPV status)\u2019 to impute for missing scores.The exercise of testing variables and building model drew on current theories about risk factors and drivers of violence against women. The selection of variables as putative risk factors was informed by the state of knowledge in the field. Drawing on a life-course modified ecological model of violence risk , we concTo show associations between independent variables that were putative risk factors, we first conducted a bivariable analysis with a (by type) lifetime IPV exposure measure and a multinomial regression with no physical, sexual, or severe economic/financial violence as the comparison group. A maximum likelihood multinomial logit model, which adjusted for the survey design, was used to compare factors associated with different types of IPV experienced with the no-violence reference category. We initially fitted bivariable models and then included all factors that were significantly associated with IPV experience in the bivariate models into an overall model, which was adjusted for the country and age group of the woman.We examined factors associated with past-year experience of IPV considering the same independent variables, but with a past-year exposure to any physical and/or sexual IPV as the outcome, due to sample size considerations, we did not perform multinomial modelling. We sought to model 19 covariates in the logistic regression model, which, according to generally accepted rules of thumb , would rP < or = 0.05 in the model, which is adjusted for country/site and age-group of the woman.Multivariable logistic regression was used to determine risk factors associated with past-year physical and/or sexual IPV experience in women, with those not experiencing this as the reference group. To enable the use of a variable on frequency of quarrelling, which was not measured in Cambodia, a dummy level for Cambodia was created for the quarrelling variable for use in the logistic regression model. All variables were included in the multivariate analysis. We focus the discussion on variables with The population attributable fractions (PAFs) for each category of IPV were calculated using the formula PAF = ((RRR \u2212 1) / RRR) * Pe, where RRR is the adjusted relative risk ratio from the adjusted model and Pe is the proportion of women who had experienced that particular IPV type and who had the exposure.Structural equation modelling (SEM) was conducted using Stata 13.0 to assess the interrelationship between variables associated with physical and/or sexual IPV in the multinomial regression model. The model outcome was a past-year IPV variable that had 4 levels drawn from the physical and sexual IPV questions: no exposure, sexual IPV, physical IPV, and physical or sexual IPV. The correlation between each hypothesized variable and the IPV variable was then tested by building variable pairs. All associations were tested by running a full-information maximum likelihood method to deal with missing values. This method was chosen over multiple imputations because it has been shown to yield superior results in structural equation modelling . As a neP < 0.05 level) from the exogenous variables to IPV in order to ensure model parsimony. Before adjusting standard errors for clustering of participants in countries, model fit was very good (p(\u03c72) = 0.519, RMSEA < 0.001, CFI = 1.000, and TLI = 1.001). After adjusting for clustering, the coefficient of determination (CD) was 0.215. The model did not include any error covariances.We fitted a path model using full information maximum likelihood (FIML) estimation to model all available data. The final model was built based on theory and statistically meaningful modifications using backwards elimination to exclude endogenous variables that did not mediate any path  were ever-partnered. Of the ever-partnered women, 90 (3.3%) did not respond to any of the questions related to IPV experience and were thus excluded from analysis. In total, 5,206 men were interviewed in the 4 countries, and 4,360 (83.8%) had ever been partnered. Four thousand and fifteen men completed the IPV questions, and 5,062 completed the non-partner rape questions.Comparing lifetime reports of women\u2019s experiences and men\u2019s reports of IPV by type from the 4 countries  reveals In Cambodia, 0.4% (95% CI 0.1%\u20131.73%) of women had experienced nonpartner rape in the past year, and 1.9% (95% CI 1.12%\u20132.70%) of men disclosed perpetration. In China, 2.3% (95% CI 1.49%\u20133.43%) of women had experienced nonpartner rape in the past year, and 1.7% (95% CI 0.94%\u20132.52%) of men disclosed perpetration. In Bougainville, 5.7% (95% CI 4.21%\u20137.75%) of women had experienced nonpartner rape in the past year, and 11.7% (95% CI 9.02%\u201314.30%) of men disclosed perpetration. In Sri Lanka, 0.5% (95% CI 0.15%\u20131.40%) of women had experienced nonpartner rape in the past year, and 0.8% (95% CI 0.22%\u20131.43%) of men disclosed perpetration.P < 0.001) as those in which the husband provided, another provided, or both the husband and wife shared equally in providing.The prevalence of past-year physical and/or sexual IPV experience increased with age . PovertyAll 3 forms of childhood abuse  and witnessing abuse of mother were more common among women with past-year physical or sexual IPV experience. Women whose partners earned more than them had a lower past-year IPV prevalence than those earning the same as their partners or women who earned more. Partner characteristics associated with women\u2019s past-year IPV experience were the male partner\u2019s regular alcohol use, ever or past-year drug use, lack of fidelity, and unemployment. Women who were highly controlled by their partner were more likely to have experienced past-year IPV, as were those who quarrelled more often and those holding less gender-inequitable views.Results for the structural equation model are presented in Between a quarter and two-thirds of women in the 4 countries studied had experienced IPV, and 1.7% and 15.9% had experienced nonpartner rape. There was very great diversity in the prevalence of IPV between countries, as previously reported in Asia and the Pacific [We would not necessarily expect men\u2019s and women\u2019s reports of nonpartner sexual violence to concur, and some women are at much higher risk than others in the population and may experience multiple rapes . AlthougWe saw 4 important groups of risk factors for IPV experience. First, our results confirm that past-year IPV victimisation is more common in a context of poverty . SecondlWitnessing abuse of one\u2019s mother has been found to be associated with both experience of and perpetration of IPV in many studies ,28\u201335. WThe third variable group consists of partner characteristics: his drinking, past-year drug use, controlling behaviour, unemployment, and fidelity. Generally, these are previously well-established risk factors, although research with men has not confirmed associations with drug use in Asia and the Pacific, except in relation to perpetration of multiple perpetrator rape ,10. AlcoThe frequency of quarrelling was very strongly associated with IPV, as it was in the models of men\u2019s perpetration in the 4 countries . AlthougOne of the most important findings of the structural model was a pathway that can be interpreted as indicating variables that build women\u2019s resilience to violence. This linked higher wealth, higher educational attainment, and having more gender-equitable attitudes. This is very important because all of these factors are amenable to intervention, and it highlights the role of poverty reduction and interventions to enhance girls\u2019 schooling, which may be supported for many reasons related to development and the general upliftment of women, in IPV prevention. In this study, the Gender Equitable Men (GEM) scale was used to measure women\u2019s gender attitudes. This is a broad measure that includes attitudes towards the use of violence against women. The latter alone have been shown to be very strongly associated with risk of violence ,42; howeEconomic empowerment has been shown to be a fruitful area of intervention with women , but morReducing childhood trauma exposure is ultimately critical to reducing women\u2019s experience of violence and is strongly related to poverty. Whilst there is much work on early interventions in childhood to reduce the experience of trauma and IPV in the next generation, it is possible that poverty reduction will have the greatest impact.The study findings reflect the sampled sites; generalizability beyond this is unclear, and the combined dataset analysed here does not reflect the whole region. Since the research was cross-sectional, temporality may be questioned, but since this was recent violence, this is not likely to be a great problem. All the prevalence estimates for violence were compared with estimates weighted for the number of eligible men and women per household. The latter were not significantly different in any site, and thus, we have used unweighted estimates. The main analysis was on past-year IPV exposure, and because this is less common than lifetime exposure, the power of the analysis was inevitably impacted. However, the focus has strengthened the interpretability of the results for programming, as it is the goal of IPV prevention to reduce exposure of women at risk in the future and recent abuse is the best measure of this. A study limitation is that we do not have a comparison of men\u2019s and women's reports from the same relationship. In accordance with WHO ethics and safety guidelines, we did not interview men and women in the same location, much less in couples. The motivation is to avoid the  possibility of retaliatory violence associated with partners learning of the interview content. This risk is not justified in cross-sectional research but prevents comparison of couples\u2019 reports.Our findings suggest that newly emphasised past-year IPV indicators that were developed to track SDG 5 would be reasonably reliable if based on women\u2019s interviews. Interviews with men to track past-year nonpartner rape perpetration are important. We have shown an important IPV resilience pathway. This helps us to understand why interventions that combine women\u2019s economic empowerment and building gender-equitable attitudes (and communication skills), such as Pronyk and colleagues\u2019 Image , may be S1 Fig(TIF)Click here for additional data file.S1 STROBE ChecklistChecklist of items that should be included in reports of cross-sectional studies.(DOC)Click here for additional data file.S1 Table(DOCX)Click here for additional data file.S2 Table(DOCX)Click here for additional data file."]}
{"representative": "Intimate partner violence (IPV) is a global problem that affects one-third of all women. The present study aims to develop and determine the validity of a screening instrument for the detection of IPV in pregnant women in Tanzania and Vietnam and to determine the minimum number of questions needed to identify IPV.th-34th gestational week where the World Health Organization (WHO) IPV questionnaire was used as the gold standard. In all, 255 combinations of eight different questions were first tested on the Tanzanian study population where sensitivity, specificity, positive predictive value, negative predictive value and accuracy were calculated. In the evaluation of the performance of the question combinations, different IPV types and the frequency of abusive acts were considered. The question combinations that performed best in Tanzania were subsequently evaluated in the Vietnamese study population.An IPV screening instrument based on eight questions was tested on 1,116 Tanzanian and 1,309 Vietnamese women who attended antenatal care before 24 gestational weeks. The women were re-interviewed during their 30In Tanzania, a combination of three selected questions including one question on emotional IPV, one on physical IPV and one on sexual IPV was found to be most effective in identifying women who are exposed to at least one type of IPV during pregnancy . The performance of the identified combination was slightly less effective in Vietnam . Focusing on different IPV types, the best performance was found for exposure to physical IPV in both Tanzania  and Vietnam . In both countries, the sensitivity increased with the frequency of abuse whereas the specificity decreased.By asking pregnant women three simple questions we were able to identify women who were exposed to IPV during pregnancy in two different countries. The question combination performed best in assessing physical IPV where it identified 93% and 96% of Vietnamese and Tanzanian women, respectively, who were exposed to physical IPV. Intimate partner violence (IPV) is a worldwide problem, which globally affects one-third of all women \u20134. IPV dAddressing the problem of IPV is an international priority  and consIn the implementation of any screening programme, the validity of the screening instruments should be considered. According to a systematic review, there is a great variation in sensitivity (0.30\u20131.00) and specificity (0.55\u20130.99) of different IPV screening instruments used in health care settings . There iAccording to a recent Cochrane review, screening of women who attend antenatal care may be helpful in identifying women who are exposed to IPV . SimilarAlthough IPV during pregnancy is a major health problem in L/MIC, with severe adverse health consequences, few screening programmes have been evaluated and implemented in such settings . Againstth gestational week were enrolled. In both settings, the women were interviewed when included in the study, at 30\u201334 gestational weeks, at delivery, and 4\u201312 weeks postpartum. At enrolment, information on socioeconomic and reproductive characteristics was obtained and an agreement was reached regarding time and place for the second interview. In all, 1,116 Tanzanian women and 1,309 Vietnamese women were re-interviewed in gestational week 30\u201334. The second interview, which was performed in homes or similar places where participants felt comfortable to talk freely, included detailed information on the women\u2019s exposure to IPV.The present study was part of a larger research project, \"The Impact of Violence on Reproductive Health in Tanzania and Vietnam (PAVE)\", with the overall aim of assessing the associations between IPV and adverse pregnancy outcomes and antenatal depression in Tanzania and Vietnam. The study was performed simultaneously in the two countries. In Tanzania, women were recruited from Majengo Health Centre and Pasua Health Centre, in Moshi District, and in Vietnam they were recruited from Dong Anh Hospital and Bac Thang Long Hospital in Dong Anh District. A total of 1,123 Tanzanian women and 1,337 Vietnamese women who attended antenatal care before the 24Different questionnaires and screening tools ,9,16 werTo investigate the validity of the 8 questions (4 questions on IPV exposure during the past 12 months and 4 questions on IPV exposure during pregnancy), the pregnant women were re-interviewed in gestational week 30\u201334. At the re-interview, the full WHO questionnaire for assessing Domestic Violence against Women was applied and used as a \u201cgold standard\u201d. The WHO questionnaire comprises 5 questions on emotional IPV, 6 questions on physical IPV and 4 questions on sexual IPV. For each question, the women are asked if they ever have been exposed to IPV and if yes, if they have been exposed during the past 12 months, and if yes, whether during the past 12 months it has happened once, a few times or many times. Since the study aimed at assessing exposure to IPV during pregnancy, the assessment period of \u201cpast 12 months\u201d in the original instrument was changed to \u201cduring this pregnancy\u201d and to operationalize the frequency of IPV exposure, \u201ca few times\u201d was defined as 2\u20135 times and \u201cmany times\u201d as more than 5 times.All data were double-entered in Epi Data (Version 3.1) by two different data clerks, and discrepancies were identified and subsequently corrected according to the original data forms. All statistical analyses were performed using the STATA software package (version 14).To determine the properties of the eight questions for detecting exposure to at least one type of IPV (regardless of type), emotional IPV, physical IPV, and sexual IPV, the following values were determined: 1) sensitivity (proportion of women exposed to IPV who screened positive), 2) specificity (proportion of women not exposed to IPV who screened negative), 3) positive predictive value , 4) negative predictive value  and 5) accuracy. In all, 255 question combinations were generated for each type of IPV. The minimum score possible was zero  and the maximum score possible was eight . To select the optimal cut-off score, the properties of the question combinations were computed according to different cut-off levels (cut-off 1\u20138).at least one type of IPV and selected the combinations with a sensitivity > 0.75, an NPV > 0.75, and accuracy > 0.75 when assessed at a cut-off level of 1. This resulted in 144 combinations, which were subsequently assessed for their properties in predicting emotional IPV, physical IPV and sexual IPV with an accuracy > 0.70. The question combinations were subsequently evaluated for their properties in predicting exposure to the different forms of IPV according to the frequency of exposure; only once, 2\u20135 times and more than 5 times.The questions\u2019 performance was first tested on the Tanzanian study population. In the evaluation of the different combinations of the questions, we first gave priority to their properties in predicting The combinations that performed best in identifying the different forms of IPV  were thereafter examined according to the cut-off value which resulted in highest sensitivity and specificity. Then, it was observed whether this cut-off also yielded the highest accuracy.emotional IPV, physical IPV and sexual IPV. The diagnostic ability of the question combination found to have the highest sensitivity and specificity for determining all four types of IPV was tested for different cut-off values in the Vietnamese study population as well.Finally, the combinations that were found to perform best in Tanzania were evaluated on the Vietnamese study population ,18 for tFemale nurses and community collaborators were recruited as research assistants. They received comprehensive training on the concepts of gender, gender discrimination, inequality, domestic violence and how to deal with participants who were exposed to violence. The WHO Ethical and Safety Recommendations for Research on Domestic Violence against Women  was usedAll women were informed in detail about the study and written informed consent was obtained. In Tanzania, none of the participants were aged below 18 years. In Vietnam, two were aged 17 and accompanied by their mother, who also signed the consent form. Ethical approval of the study was obtained from the Ethical Review Committee at Kilimanjaro Christian Medical University and Hanoi Medical University.In Tanzania, a total of 1,123 women met the inclusion criteria. As seven women did not show up for IPV assessment in gestational week 30\u201334, the final sample comprised of 1,116 women. In Vietnam, 1,337 women fulfilled the inclusion criteria and 1,309 presented for IPV assessment in gestational week 30\u201334.Socio-economic characteristics and ever-exposure to IPV among Tanzanian and Vietnamese women are listed in When focusing on exposure to IPV during pregnancy, almost one-third of the Tanzanian women had been exposed to at least one type of IPV during their current pregnancy, 23% had been exposed to emotional IPV, 6.0% to physical IPV and 15% to sexual IPV . The vasThe psychometric properties for detecting at least one type of IPV , using the WHO questionnaire as the \u201cgold standard\u201d were tested for all 255 combinations of the eight questions among Tanzanian women. Four combinations: 1+4, 1+2+4, 1+3+4, and 1+2+3+4 were found to have sensitivity > 0.75, NPV > 0.75 and accuracy > 0.70 for predicting at least one type of IPV  . QuestioThe diagnostic ability of question combination 1+3+4 in identifying IPV using the WHO tool as gold standard was tested for different cut-off values in Tanzania  and VietA combination of three screening questions was found to be effective in identifying women exposed to IPV during pregnancy. The found 3-item combination performed best in Tanzanian whereas the sensitivity was slightly lower in Vietnam. When evaluating the test performance for the different types of IPV, the 3-item combination performed best among women who were exposed to physical IPV, with a sensitivity of 0.93 among Tanzanian women and 0.96 among Vietnamese women.Approximately one-third of the participants in both countries had been exposed to at least one type of IPV during pregnancy. When focusing on the different types of IPV, 23% had been exposed to emotional IPV, 6.0% to physical IPV and 15% to sexual IPV in the Tanzanian setting. The corresponding Vietnamese figures were 35%, 3.5% and 10%, respectively. Globally, there is a great variation on the reported prevalence of IPV, which has been illustrated in a recent systematic review based on data from antenatal clinics, where the prevalence rates of IPV during pregnancy were found to be 2\u201357% (n\u200a = \u200a13 studies), with meta-analysis yielding an overall prevalence of 15% . The larWe found that a screening based on the three questions with a 93% probability would be positive among Tanzanian women exposed to physical IPV and with 96% probability would be positive among Vietnamese women exposed to physical IPV. When focusing on emotional and sexual IPV, the probability dropped to 78% and 87% among Tanzanian women and to 76% and 71% among Vietnamese women. The three-question combination\u2019s poorer performance in predicting emotional IPV may reflect that an experience defined as emotional IPV in a screening instrument is not always considered as abuse by the victim and therefore the act may not be disclosed by them. When it comes to sexual IPV, a comparatively lower sensitivity was found in the Vietnamese study setting. This shortcoming of the found item combination most likely reflect that there are a number of barriers that may hinder questioning adult women about sexual abuse as well as barriers that may hinder women from sharing such experiences. In other words, a brief screener, like the one we have developed, may not provide sufficient confidentiality to obtain valid answers on sensitive topics such as sexual activity. Other studies have likewise shown that asking about sexual IPV specifically may be even more difficult than asking about physical IPV . This maBased on our findings we argue that antenatal care can play an important role in identifying women who are exposed to IPV. It should, however, also be stressed that screening for IPV has to go hand in hand with supportive responses and information so the women can plan for their safety. Hence, in any screening for IPV, the expenditure of resources spent on screening must be justifiable in terms of eliminating or decreasing IPV exposure and associated adverse outcome. Therefore acceptable and affordable interventions must be in place before routine IPV screening is considered implemented . In the There are some important limitations in this study. Firstly, both the screening questions and the WHO questionnaire rely on interviews performed by health staff, which implies that the results do not automatically reflect the IPV that actually took place and there is a risk that the women may have denied or minimized the IPV they had been exposed to. Alternative ways to obtain information on IPV exposure have been evaluated and the results have been compiled in a recent systematic review. The review found that computer-assisted self-administered questionnaire lead to higher rates of IPV disclosure in comparison to both face-to-face interview and self-administered questionnaires on paper . It may,By asking pregnant women three simple questions, one on emotional IPV, one on physical IPV and one on sexual IPV, we were able to identify women who were exposed to IPV during pregnancy in Tanzania and Vietnam. The question combination performed best in predicting physical IPV, where it identified 93% and 96% of Tanzanian and Vietnamese women, respectively, who were exposed to physical IPV measured according to the gold standard. Based on our findings we conclude that the developed screening instrument can help identifying women exposed to IPV so relevant action can be taken to address the problem and its associated consequences. Ideally, the tool should be incorporated in the first antenatal care visit together with questions about other risk factors that are routinely asked in early pregnancy.S1 Dataset(SAV)Click here for additional data file.S2 Dataset(SAV)Click here for additional data file.S1 Fig(TIF)Click here for additional data file.S2 Fig(TIF)Click here for additional data file.", "texts": ["Intimate partner violence (IPV) is a global problem that affects one-third of all women. The present study aims to develop and determine the validity of a screening instrument for the detection of IPV in pregnant women in Tanzania and Vietnam and to determine the minimum number of questions needed to identify IPV.th-34th gestational week where the World Health Organization (WHO) IPV questionnaire was used as the gold standard. In all, 255 combinations of eight different questions were first tested on the Tanzanian study population where sensitivity, specificity, positive predictive value, negative predictive value and accuracy were calculated. In the evaluation of the performance of the question combinations, different IPV types and the frequency of abusive acts were considered. The question combinations that performed best in Tanzania were subsequently evaluated in the Vietnamese study population.An IPV screening instrument based on eight questions was tested on 1,116 Tanzanian and 1,309 Vietnamese women who attended antenatal care before 24 gestational weeks. The women were re-interviewed during their 30In Tanzania, a combination of three selected questions including one question on emotional IPV, one on physical IPV and one on sexual IPV was found to be most effective in identifying women who are exposed to at least one type of IPV during pregnancy . The performance of the identified combination was slightly less effective in Vietnam . Focusing on different IPV types, the best performance was found for exposure to physical IPV in both Tanzania  and Vietnam . In both countries, the sensitivity increased with the frequency of abuse whereas the specificity decreased.By asking pregnant women three simple questions we were able to identify women who were exposed to IPV during pregnancy in two different countries. The question combination performed best in assessing physical IPV where it identified 93% and 96% of Vietnamese and Tanzanian women, respectively, who were exposed to physical IPV. Intimate partner violence (IPV) is a worldwide problem, which globally affects one-third of all women \u20134. IPV dAddressing the problem of IPV is an international priority  and consIn the implementation of any screening programme, the validity of the screening instruments should be considered. According to a systematic review, there is a great variation in sensitivity (0.30\u20131.00) and specificity (0.55\u20130.99) of different IPV screening instruments used in health care settings . There iAccording to a recent Cochrane review, screening of women who attend antenatal care may be helpful in identifying women who are exposed to IPV . SimilarAlthough IPV during pregnancy is a major health problem in L/MIC, with severe adverse health consequences, few screening programmes have been evaluated and implemented in such settings . Againstth gestational week were enrolled. In both settings, the women were interviewed when included in the study, at 30\u201334 gestational weeks, at delivery, and 4\u201312 weeks postpartum. At enrolment, information on socioeconomic and reproductive characteristics was obtained and an agreement was reached regarding time and place for the second interview. In all, 1,116 Tanzanian women and 1,309 Vietnamese women were re-interviewed in gestational week 30\u201334. The second interview, which was performed in homes or similar places where participants felt comfortable to talk freely, included detailed information on the women\u2019s exposure to IPV.The present study was part of a larger research project, \"The Impact of Violence on Reproductive Health in Tanzania and Vietnam (PAVE)\", with the overall aim of assessing the associations between IPV and adverse pregnancy outcomes and antenatal depression in Tanzania and Vietnam. The study was performed simultaneously in the two countries. In Tanzania, women were recruited from Majengo Health Centre and Pasua Health Centre, in Moshi District, and in Vietnam they were recruited from Dong Anh Hospital and Bac Thang Long Hospital in Dong Anh District. A total of 1,123 Tanzanian women and 1,337 Vietnamese women who attended antenatal care before the 24Different questionnaires and screening tools ,9,16 werTo investigate the validity of the 8 questions (4 questions on IPV exposure during the past 12 months and 4 questions on IPV exposure during pregnancy), the pregnant women were re-interviewed in gestational week 30\u201334. At the re-interview, the full WHO questionnaire for assessing Domestic Violence against Women was applied and used as a \u201cgold standard\u201d. The WHO questionnaire comprises 5 questions on emotional IPV, 6 questions on physical IPV and 4 questions on sexual IPV. For each question, the women are asked if they ever have been exposed to IPV and if yes, if they have been exposed during the past 12 months, and if yes, whether during the past 12 months it has happened once, a few times or many times. Since the study aimed at assessing exposure to IPV during pregnancy, the assessment period of \u201cpast 12 months\u201d in the original instrument was changed to \u201cduring this pregnancy\u201d and to operationalize the frequency of IPV exposure, \u201ca few times\u201d was defined as 2\u20135 times and \u201cmany times\u201d as more than 5 times.All data were double-entered in Epi Data (Version 3.1) by two different data clerks, and discrepancies were identified and subsequently corrected according to the original data forms. All statistical analyses were performed using the STATA software package (version 14).To determine the properties of the eight questions for detecting exposure to at least one type of IPV (regardless of type), emotional IPV, physical IPV, and sexual IPV, the following values were determined: 1) sensitivity (proportion of women exposed to IPV who screened positive), 2) specificity (proportion of women not exposed to IPV who screened negative), 3) positive predictive value , 4) negative predictive value  and 5) accuracy. In all, 255 question combinations were generated for each type of IPV. The minimum score possible was zero  and the maximum score possible was eight . To select the optimal cut-off score, the properties of the question combinations were computed according to different cut-off levels (cut-off 1\u20138).at least one type of IPV and selected the combinations with a sensitivity > 0.75, an NPV > 0.75, and accuracy > 0.75 when assessed at a cut-off level of 1. This resulted in 144 combinations, which were subsequently assessed for their properties in predicting emotional IPV, physical IPV and sexual IPV with an accuracy > 0.70. The question combinations were subsequently evaluated for their properties in predicting exposure to the different forms of IPV according to the frequency of exposure; only once, 2\u20135 times and more than 5 times.The questions\u2019 performance was first tested on the Tanzanian study population. In the evaluation of the different combinations of the questions, we first gave priority to their properties in predicting The combinations that performed best in identifying the different forms of IPV  were thereafter examined according to the cut-off value which resulted in highest sensitivity and specificity. Then, it was observed whether this cut-off also yielded the highest accuracy.emotional IPV, physical IPV and sexual IPV. The diagnostic ability of the question combination found to have the highest sensitivity and specificity for determining all four types of IPV was tested for different cut-off values in the Vietnamese study population as well.Finally, the combinations that were found to perform best in Tanzania were evaluated on the Vietnamese study population ,18 for tFemale nurses and community collaborators were recruited as research assistants. They received comprehensive training on the concepts of gender, gender discrimination, inequality, domestic violence and how to deal with participants who were exposed to violence. The WHO Ethical and Safety Recommendations for Research on Domestic Violence against Women  was usedAll women were informed in detail about the study and written informed consent was obtained. In Tanzania, none of the participants were aged below 18 years. In Vietnam, two were aged 17 and accompanied by their mother, who also signed the consent form. Ethical approval of the study was obtained from the Ethical Review Committee at Kilimanjaro Christian Medical University and Hanoi Medical University.In Tanzania, a total of 1,123 women met the inclusion criteria. As seven women did not show up for IPV assessment in gestational week 30\u201334, the final sample comprised of 1,116 women. In Vietnam, 1,337 women fulfilled the inclusion criteria and 1,309 presented for IPV assessment in gestational week 30\u201334.Socio-economic characteristics and ever-exposure to IPV among Tanzanian and Vietnamese women are listed in When focusing on exposure to IPV during pregnancy, almost one-third of the Tanzanian women had been exposed to at least one type of IPV during their current pregnancy, 23% had been exposed to emotional IPV, 6.0% to physical IPV and 15% to sexual IPV . The vasThe psychometric properties for detecting at least one type of IPV , using the WHO questionnaire as the \u201cgold standard\u201d were tested for all 255 combinations of the eight questions among Tanzanian women. Four combinations: 1+4, 1+2+4, 1+3+4, and 1+2+3+4 were found to have sensitivity > 0.75, NPV > 0.75 and accuracy > 0.70 for predicting at least one type of IPV  . QuestioThe diagnostic ability of question combination 1+3+4 in identifying IPV using the WHO tool as gold standard was tested for different cut-off values in Tanzania  and VietA combination of three screening questions was found to be effective in identifying women exposed to IPV during pregnancy. The found 3-item combination performed best in Tanzanian whereas the sensitivity was slightly lower in Vietnam. When evaluating the test performance for the different types of IPV, the 3-item combination performed best among women who were exposed to physical IPV, with a sensitivity of 0.93 among Tanzanian women and 0.96 among Vietnamese women.Approximately one-third of the participants in both countries had been exposed to at least one type of IPV during pregnancy. When focusing on the different types of IPV, 23% had been exposed to emotional IPV, 6.0% to physical IPV and 15% to sexual IPV in the Tanzanian setting. The corresponding Vietnamese figures were 35%, 3.5% and 10%, respectively. Globally, there is a great variation on the reported prevalence of IPV, which has been illustrated in a recent systematic review based on data from antenatal clinics, where the prevalence rates of IPV during pregnancy were found to be 2\u201357% (n\u200a = \u200a13 studies), with meta-analysis yielding an overall prevalence of 15% . The larWe found that a screening based on the three questions with a 93% probability would be positive among Tanzanian women exposed to physical IPV and with 96% probability would be positive among Vietnamese women exposed to physical IPV. When focusing on emotional and sexual IPV, the probability dropped to 78% and 87% among Tanzanian women and to 76% and 71% among Vietnamese women. The three-question combination\u2019s poorer performance in predicting emotional IPV may reflect that an experience defined as emotional IPV in a screening instrument is not always considered as abuse by the victim and therefore the act may not be disclosed by them. When it comes to sexual IPV, a comparatively lower sensitivity was found in the Vietnamese study setting. This shortcoming of the found item combination most likely reflect that there are a number of barriers that may hinder questioning adult women about sexual abuse as well as barriers that may hinder women from sharing such experiences. In other words, a brief screener, like the one we have developed, may not provide sufficient confidentiality to obtain valid answers on sensitive topics such as sexual activity. Other studies have likewise shown that asking about sexual IPV specifically may be even more difficult than asking about physical IPV . This maBased on our findings we argue that antenatal care can play an important role in identifying women who are exposed to IPV. It should, however, also be stressed that screening for IPV has to go hand in hand with supportive responses and information so the women can plan for their safety. Hence, in any screening for IPV, the expenditure of resources spent on screening must be justifiable in terms of eliminating or decreasing IPV exposure and associated adverse outcome. Therefore acceptable and affordable interventions must be in place before routine IPV screening is considered implemented . In the There are some important limitations in this study. Firstly, both the screening questions and the WHO questionnaire rely on interviews performed by health staff, which implies that the results do not automatically reflect the IPV that actually took place and there is a risk that the women may have denied or minimized the IPV they had been exposed to. Alternative ways to obtain information on IPV exposure have been evaluated and the results have been compiled in a recent systematic review. The review found that computer-assisted self-administered questionnaire lead to higher rates of IPV disclosure in comparison to both face-to-face interview and self-administered questionnaires on paper . It may,By asking pregnant women three simple questions, one on emotional IPV, one on physical IPV and one on sexual IPV, we were able to identify women who were exposed to IPV during pregnancy in Tanzania and Vietnam. The question combination performed best in predicting physical IPV, where it identified 93% and 96% of Tanzanian and Vietnamese women, respectively, who were exposed to physical IPV measured according to the gold standard. Based on our findings we conclude that the developed screening instrument can help identifying women exposed to IPV so relevant action can be taken to address the problem and its associated consequences. Ideally, the tool should be incorporated in the first antenatal care visit together with questions about other risk factors that are routinely asked in early pregnancy.S1 Dataset(SAV)Click here for additional data file.S2 Dataset(SAV)Click here for additional data file.S1 Fig(TIF)Click here for additional data file.S2 Fig(TIF)Click here for additional data file."]}
{"representative": "There is growing awareness of the problem of intimate partner violence (IPV) among military populations. IPV victimisation has been shown to be associated with mental disorder. A better understanding of the link between IPV and mental disorder is needed to inform service development to meet the needs of military families. We aimed to systematically review the literature on the association between IPV victimisation and mental health disorders among military personnel.Searches of four electronic databases  were supplemented by reference list screening. Heterogeneity among studies precluded a meta-analysis.Thirteen studies were included. There was stronger evidence for an association between IPV and depression/alcohol problems than between IPV and PTSD. An association between IPV and mental health problems was more frequently found among veterans compared to active duty personnel. However, the link between IPV and alcohol misuse was more consistently found among active duty samples. Finally, among active duty personnel psychological IPV was more consistently associated with depression/alcohol problems than physical/sexual IPV. The review highlighted the lack of research on male IPV victimisation in the military.There is evidence that the burden of mental health need may be significant among military personnel who are victims of IPV. The influence of attitudes towards gender in the military on research in this area is discussed. Further research is needed to inform development of services and policy to reduce IPV victimisation and the mental health consequences among military personnel.The online version of this article (doi:10.1007/s00127-017-1423-8) contains supplementary material, which is available to authorized users. Intimate partner violence (IPV) is a serious, preventable public health problem that occurs in all settings and among all religious, cultural, and socioeconomic groups . IPV incThere is a growing body of research on IPV victimisation among military populations, though these studies are very heterogeneous in terms of samples, method of measurement of IPV, and definitions of different types of IPV. To our knowledge, no UK studies exist. Studies in the US have found high levels of IPV victimisation among military personnel, both male and female \u201349, withThere is a large body of literature which has established the link between IPV victimisation and mental disorder in the general population. Research has focused on depression, PTSD, anxiety, eating disorders, substance misuse, and chronic mental illness more broadly, with the most consistent evidence highlighting a link between IPV and depression, followed by PTSD and anxiety disorders \u201372. TherThe aim of this study was, therefore, to systematically review extant studies to summarise the literature exploring IPV victimisation and specific mental health problems among male and female military personnel (both serving and ex-serving).A literature search was undertaken for studies examining mental health problems associated with IPV victimisation among military populations. Searches of the following electronic databases were carried out: Embase, Medline, PsycINFO, and Web of Science. The search terms and combinations used were identical for all four databases. Search results were limited to papers published in English. In addition to searching bibliographic databases, the reference lists of all relevant papers and reviews were searched. Authors were contacted to request raw data where necessary. This review followed PRISMA reporting guidelines and the protocol is registered with PROSPERO: registration CRD42016044119.Studies were eligible for inclusion if they: (1) involved male and/or female serving or ex-serving military personnel; (2) reported the risk of IPV victimisation among those with and without mental disorder or vice versa, and/or a measure of association between IPV and mental disorder; (3) measured IPV using a validated tool or adapted question(s); (4) measured mental health using a validated diagnostic or screening tool, e.g., the PTSD checklist (PCL), or the Alcohol Use Disorders Identification Test (AUDIT); (5) presented the results of peer reviewed research based on any quantitative study design capable of providing the data listed above; and (6) had a sample size of over 100 participants. IPV was defined as \u201cany incident of threatening behaviour, violence or abuse  between adults who are or have been intimate partners regardless of gender or sexuality\u201d . Mental Figure\u00a0Heterogeneity among the studies in this review (primarily regarding the timing and type of IPV studied) precluded a meta-analysis.The key characteristics of the included studies are summarised in Table\u00a0As shown in Table\u00a0Studies examined IPV measured over a variety of time periods. Four studies reported on past-year IPV , 84, 85,Nine studies examined depressive symptoms among individuals who have experienced IPV victimisation , 84, 85,n\u00a0=\u00a0529) similarly found that emotional violence victimisation (defined as experiencing threats of violence) was significantly associated with depression [The majority of study findings will be reported according to gender. However, two high-quality studies explored the association between depression and IPV experienced over the course of the current relationship among samples of male and female Canadian Armed Forces (CAF) members and did not stratify analyses by gender. The first study used a representative sample of 1745 CAF members and found that \u2018probable depression\u2019 was significantly associated with increased emotional and/or financial abuse, but not with any physical and/or sexual IPV . The secn\u00a0=\u00a0248), the researchers grouped participants according to six different patterns of violence . It was found that mean depression scores were significantly higher among females who reported experiencing violence by a male civilian spouse compared to those who reported no violence. Mean depression scores did not differ significantly between the no violence group and the group in which the more severe violence was perpetrated by the enlisted female. The mean depression score for the group in which both the enlisted female and her spouse had engaged in severe violence and/or injury was significantly higher than all other group scores [In a study of past-year IPV among active duty females married to civilian spouses  IPV was significantly associated with increased cases of depression [n\u00a0=\u00a0616) found no significant association between physical and/or sexual IPV and cases of depression [n\u00a0=\u00a0369) during military service found no significant difference between the mean depression score of women who experienced sexual IPV compared to those who had not experienced sexual abuse [With regard to lifetime IPV, a high-quality study utilised data from a nation-wide telephone survey of non-institutionalised adults in the US and found that among female veterans  found that past-year physical and psychological aggression was significantly associated with depression [n\u00a0=\u00a013,765 males) found that among veterans lifetime IPV  was significantly associated with increased depression [One study of male active duty Army personnel  found that 32.2% of those who reported lifetime IPV had a PTSD diagnosis, compared to 14.8% of those who did not report IPV, and PTSD was significantly associated with physical IPV [n\u00a0=\u00a0616) did not find a significant association between physical and/or sexual lifetime IPV and PTSD [A study of 160 female VA patients found that 41.4% of females who reported past-year IPV had a PTSD diagnosis, compared to 19.6% of those who did not report IPV, and past-year physical and/or psychological IPV was found to be significantly associated with PTSD . Similarical IPV . In contand PTSD . Finallyand PTSD . The PTSSeven studies explored alcohol misuse among individuals who have experienced IPV , 84, 85,n\u00a0=\u00a042,744; 8031 females) found that past-year clinically significant emotional abuse (defined as at least one reported act that caused significant distress that interfered with the victim\u2019s functioning) was significantly associated with alcohol problems [A high-quality study utilising a representative sample of active duty US Air Force members (problems . In contproblems  and did problems .n\u00a0=\u00a0249) found a significant association between sexual IPV  and problem drinking, but no association with either physical  or psychological IPV [n\u00a0=\u00a02670) reported that lifetime physical IPV increased significantly with AUDIT-C scores of five or more [Two studies examined lifetime IPV victimisation and alcohol problems among clinical populations of female VA patients , 82. One or more . HoweverA high-quality study of 34,713 male US Air Force members found that clinically significant emotional abuse was significantly associated with alcohol problems . AnotherA study of 160 female VA patients found that of those who reported IPV, 50% reported mental health multi-morbidity , compared to 20.6% of those who did not report IPV. Past-year physical and/or psychological IPV victimisation was significantly associated with mental health multi-morbidity .The aim of this review was to explore the association between IPV victimisation and mental health problems among current and former military personnel. The number and quality of studies which found an association between IPV and depression/alcohol problems was higher than for IPV and PTSD. An association between IPV and mental health problems was more frequently found in studies of veterans compared to active duty personnel. However, the link between IPV and alcohol misuse was more consistently found among active duty samples. Among active duty personnel, psychological IPV was more consistently associated with depression/alcohol problems than physical/sexual IPV.Six of the seven studies that examined the association between IPV and depression found a significant association after controlling for potential confounders, with four studies being of high quality. All studies that explored psychological IPV and depression found a significant association , 45, 54.Three of the five studies that examined the association between IPV and PTSD found a significant association after controlling for confounders. All three studies utilised female veteran samples, and none were rated as high quality. Two studies of active duty personnel  did not find a statistically significant association after adjustment for confounders , 58 see. Only onFour of the five studies  that investigated the association between IPV and alcohol problems found a significant association after controlling for potential confounders. An association between IPV and alcohol problems was more consistently found among male compared to female personnel in this review. However, it should be noted that the one high-quality study providing separate data on males and females reported identical odds ratios for emotional IPV and alcohol problems . Among mThe National Violence Against Women Survey (NVAWS) of males and females aged 18\u201365 found that psychological IPV was more strongly associated with adverse health outcomes (including depressive symptoms and substance use) than physical IPV . It is pSignificant associations between IPV and depression/PTSD were more consistently found among veterans than active duty personnel. Research has confirmed the under-reporting of mental health problems among serving military personnel , 100. IdResearch is also emerging showing higher rates of mental health and social problems among veterans than among active duty personnel , 111. A The number and quality of studies finding an association between IPV and alcohol problems were found to be higher among active duty than veteran samples. There is a culture of excess alcohol consumption in the military . It has Perhaps, the most striking finding of this review was the lack of research into male IPV victimisation and mental health. Research in the general population has shown that women are at greater risk of IPV victimisation compared to men, and the psychiatric burden of IPV is greater among women . ResearcStudies in both the general population and military samples have found that men and women are equally likely to be violent in intimate relationships, but women are more likely to suffer an injury and are at greater risk of serious and sexual assaults , 122\u2013128To our knowledge, this is the first systematic review of studies of IPV victimisation and mental disorder among military populations. The strengths of this review are that it included studies of psychological and sexual IPV, rather than just physical violence, and it only included studies that used validated tools to measure symptoms of mental disorder. The interpretation of the review findings was limited by heterogeneity among the included studies. Diverse tools were used across studies to measure IPV and there were variations in the timing of IPV studied . These inconsistencies made comparisons between studies difficult.Problems with IPV measurement were not only a significant limitation of all studies in this review, but also are a criticism of the field of IPV research as a whole \u2013132. IPVOnly two studies in this review considered differences in the severity of IPV , 85. It All studies included in this review used validated tools to measure mental disorder. However, some measured symptoms rather than providing a diagnosis, limiting the reliability and comparability of study findings. Studies did not consistently control for potential confounders when examining the association between IPV and mental disorder. Finally, all included studies were cross sectional, meaning that no conclusions can be drawn regarding the direction of causality between IPV victimisation and mental disorders.The findings from this review indicate that, just like among civilian populations , the burIPV is associated with adverse health consequences for both male and female victims , and theThis review highlights the need for further research to examine IPV victimisation and mental disorder among active duty and veteran military personnel. There is a need for greater consistency in IPV measurement to allow meta-analyses of the findings of different studies. Future research should consider the impact of IPV victimisation in order that gender differences can be better understood.Supplementary material 1 (DOCX 43\u00a0kb)Below is the link to the electronic supplementary material.", "texts": ["There is growing awareness of the problem of intimate partner violence (IPV) among military populations. IPV victimisation has been shown to be associated with mental disorder. A better understanding of the link between IPV and mental disorder is needed to inform service development to meet the needs of military families. We aimed to systematically review the literature on the association between IPV victimisation and mental health disorders among military personnel.Searches of four electronic databases  were supplemented by reference list screening. Heterogeneity among studies precluded a meta-analysis.Thirteen studies were included. There was stronger evidence for an association between IPV and depression/alcohol problems than between IPV and PTSD. An association between IPV and mental health problems was more frequently found among veterans compared to active duty personnel. However, the link between IPV and alcohol misuse was more consistently found among active duty samples. Finally, among active duty personnel psychological IPV was more consistently associated with depression/alcohol problems than physical/sexual IPV. The review highlighted the lack of research on male IPV victimisation in the military.There is evidence that the burden of mental health need may be significant among military personnel who are victims of IPV. The influence of attitudes towards gender in the military on research in this area is discussed. Further research is needed to inform development of services and policy to reduce IPV victimisation and the mental health consequences among military personnel.The online version of this article (doi:10.1007/s00127-017-1423-8) contains supplementary material, which is available to authorized users. Intimate partner violence (IPV) is a serious, preventable public health problem that occurs in all settings and among all religious, cultural, and socioeconomic groups . IPV incThere is a growing body of research on IPV victimisation among military populations, though these studies are very heterogeneous in terms of samples, method of measurement of IPV, and definitions of different types of IPV. To our knowledge, no UK studies exist. Studies in the US have found high levels of IPV victimisation among military personnel, both male and female \u201349, withThere is a large body of literature which has established the link between IPV victimisation and mental disorder in the general population. Research has focused on depression, PTSD, anxiety, eating disorders, substance misuse, and chronic mental illness more broadly, with the most consistent evidence highlighting a link between IPV and depression, followed by PTSD and anxiety disorders \u201372. TherThe aim of this study was, therefore, to systematically review extant studies to summarise the literature exploring IPV victimisation and specific mental health problems among male and female military personnel (both serving and ex-serving).A literature search was undertaken for studies examining mental health problems associated with IPV victimisation among military populations. Searches of the following electronic databases were carried out: Embase, Medline, PsycINFO, and Web of Science. The search terms and combinations used were identical for all four databases. Search results were limited to papers published in English. In addition to searching bibliographic databases, the reference lists of all relevant papers and reviews were searched. Authors were contacted to request raw data where necessary. This review followed PRISMA reporting guidelines and the protocol is registered with PROSPERO: registration CRD42016044119.Studies were eligible for inclusion if they: (1) involved male and/or female serving or ex-serving military personnel; (2) reported the risk of IPV victimisation among those with and without mental disorder or vice versa, and/or a measure of association between IPV and mental disorder; (3) measured IPV using a validated tool or adapted question(s); (4) measured mental health using a validated diagnostic or screening tool, e.g., the PTSD checklist (PCL), or the Alcohol Use Disorders Identification Test (AUDIT); (5) presented the results of peer reviewed research based on any quantitative study design capable of providing the data listed above; and (6) had a sample size of over 100 participants. IPV was defined as \u201cany incident of threatening behaviour, violence or abuse  between adults who are or have been intimate partners regardless of gender or sexuality\u201d . Mental Figure\u00a0Heterogeneity among the studies in this review (primarily regarding the timing and type of IPV studied) precluded a meta-analysis.The key characteristics of the included studies are summarised in Table\u00a0As shown in Table\u00a0Studies examined IPV measured over a variety of time periods. Four studies reported on past-year IPV , 84, 85,Nine studies examined depressive symptoms among individuals who have experienced IPV victimisation , 84, 85,n\u00a0=\u00a0529) similarly found that emotional violence victimisation (defined as experiencing threats of violence) was significantly associated with depression [The majority of study findings will be reported according to gender. However, two high-quality studies explored the association between depression and IPV experienced over the course of the current relationship among samples of male and female Canadian Armed Forces (CAF) members and did not stratify analyses by gender. The first study used a representative sample of 1745 CAF members and found that \u2018probable depression\u2019 was significantly associated with increased emotional and/or financial abuse, but not with any physical and/or sexual IPV . The secn\u00a0=\u00a0248), the researchers grouped participants according to six different patterns of violence . It was found that mean depression scores were significantly higher among females who reported experiencing violence by a male civilian spouse compared to those who reported no violence. Mean depression scores did not differ significantly between the no violence group and the group in which the more severe violence was perpetrated by the enlisted female. The mean depression score for the group in which both the enlisted female and her spouse had engaged in severe violence and/or injury was significantly higher than all other group scores [In a study of past-year IPV among active duty females married to civilian spouses  IPV was significantly associated with increased cases of depression [n\u00a0=\u00a0616) found no significant association between physical and/or sexual IPV and cases of depression [n\u00a0=\u00a0369) during military service found no significant difference between the mean depression score of women who experienced sexual IPV compared to those who had not experienced sexual abuse [With regard to lifetime IPV, a high-quality study utilised data from a nation-wide telephone survey of non-institutionalised adults in the US and found that among female veterans  found that past-year physical and psychological aggression was significantly associated with depression [n\u00a0=\u00a013,765 males) found that among veterans lifetime IPV  was significantly associated with increased depression [One study of male active duty Army personnel  found that 32.2% of those who reported lifetime IPV had a PTSD diagnosis, compared to 14.8% of those who did not report IPV, and PTSD was significantly associated with physical IPV [n\u00a0=\u00a0616) did not find a significant association between physical and/or sexual lifetime IPV and PTSD [A study of 160 female VA patients found that 41.4% of females who reported past-year IPV had a PTSD diagnosis, compared to 19.6% of those who did not report IPV, and past-year physical and/or psychological IPV was found to be significantly associated with PTSD . Similarical IPV . In contand PTSD . Finallyand PTSD . The PTSSeven studies explored alcohol misuse among individuals who have experienced IPV , 84, 85,n\u00a0=\u00a042,744; 8031 females) found that past-year clinically significant emotional abuse (defined as at least one reported act that caused significant distress that interfered with the victim\u2019s functioning) was significantly associated with alcohol problems [A high-quality study utilising a representative sample of active duty US Air Force members (problems . In contproblems  and did problems .n\u00a0=\u00a0249) found a significant association between sexual IPV  and problem drinking, but no association with either physical  or psychological IPV [n\u00a0=\u00a02670) reported that lifetime physical IPV increased significantly with AUDIT-C scores of five or more [Two studies examined lifetime IPV victimisation and alcohol problems among clinical populations of female VA patients , 82. One or more . HoweverA high-quality study of 34,713 male US Air Force members found that clinically significant emotional abuse was significantly associated with alcohol problems . AnotherA study of 160 female VA patients found that of those who reported IPV, 50% reported mental health multi-morbidity , compared to 20.6% of those who did not report IPV. Past-year physical and/or psychological IPV victimisation was significantly associated with mental health multi-morbidity .The aim of this review was to explore the association between IPV victimisation and mental health problems among current and former military personnel. The number and quality of studies which found an association between IPV and depression/alcohol problems was higher than for IPV and PTSD. An association between IPV and mental health problems was more frequently found in studies of veterans compared to active duty personnel. However, the link between IPV and alcohol misuse was more consistently found among active duty samples. Among active duty personnel, psychological IPV was more consistently associated with depression/alcohol problems than physical/sexual IPV.Six of the seven studies that examined the association between IPV and depression found a significant association after controlling for potential confounders, with four studies being of high quality. All studies that explored psychological IPV and depression found a significant association , 45, 54.Three of the five studies that examined the association between IPV and PTSD found a significant association after controlling for confounders. All three studies utilised female veteran samples, and none were rated as high quality. Two studies of active duty personnel  did not find a statistically significant association after adjustment for confounders , 58 see. Only onFour of the five studies  that investigated the association between IPV and alcohol problems found a significant association after controlling for potential confounders. An association between IPV and alcohol problems was more consistently found among male compared to female personnel in this review. However, it should be noted that the one high-quality study providing separate data on males and females reported identical odds ratios for emotional IPV and alcohol problems . Among mThe National Violence Against Women Survey (NVAWS) of males and females aged 18\u201365 found that psychological IPV was more strongly associated with adverse health outcomes (including depressive symptoms and substance use) than physical IPV . It is pSignificant associations between IPV and depression/PTSD were more consistently found among veterans than active duty personnel. Research has confirmed the under-reporting of mental health problems among serving military personnel , 100. IdResearch is also emerging showing higher rates of mental health and social problems among veterans than among active duty personnel , 111. A The number and quality of studies finding an association between IPV and alcohol problems were found to be higher among active duty than veteran samples. There is a culture of excess alcohol consumption in the military . It has Perhaps, the most striking finding of this review was the lack of research into male IPV victimisation and mental health. Research in the general population has shown that women are at greater risk of IPV victimisation compared to men, and the psychiatric burden of IPV is greater among women . ResearcStudies in both the general population and military samples have found that men and women are equally likely to be violent in intimate relationships, but women are more likely to suffer an injury and are at greater risk of serious and sexual assaults , 122\u2013128To our knowledge, this is the first systematic review of studies of IPV victimisation and mental disorder among military populations. The strengths of this review are that it included studies of psychological and sexual IPV, rather than just physical violence, and it only included studies that used validated tools to measure symptoms of mental disorder. The interpretation of the review findings was limited by heterogeneity among the included studies. Diverse tools were used across studies to measure IPV and there were variations in the timing of IPV studied . These inconsistencies made comparisons between studies difficult.Problems with IPV measurement were not only a significant limitation of all studies in this review, but also are a criticism of the field of IPV research as a whole \u2013132. IPVOnly two studies in this review considered differences in the severity of IPV , 85. It All studies included in this review used validated tools to measure mental disorder. However, some measured symptoms rather than providing a diagnosis, limiting the reliability and comparability of study findings. Studies did not consistently control for potential confounders when examining the association between IPV and mental disorder. Finally, all included studies were cross sectional, meaning that no conclusions can be drawn regarding the direction of causality between IPV victimisation and mental disorders.The findings from this review indicate that, just like among civilian populations , the burIPV is associated with adverse health consequences for both male and female victims , and theThis review highlights the need for further research to examine IPV victimisation and mental disorder among active duty and veteran military personnel. There is a need for greater consistency in IPV measurement to allow meta-analyses of the findings of different studies. Future research should consider the impact of IPV victimisation in order that gender differences can be better understood.Supplementary material 1 (DOCX 43\u00a0kb)Below is the link to the electronic supplementary material."]}
{"representative": "First, we examined the level of inter-partner agreement in reporting of men\u2019s physical, sexual, emotional and economic IPV against women in the last three and twelve months prior to the survey, ever in the relationship, and during pregnancy. Second, we conducted a convergent validity analysis to compare the relative efficacy of men\u2019s self-reports of perpetration and women\u2019s of victimization as a valid indicator of IPV against Tanzanian women using logistic regression models with village-level clustered errors. We found that, for every violence type across the recall periods of the last three months, the last twelve months and ever in the relationship, at least one in three couples disagreed about IPV occurrences in the relationship. Couples\u2019 agreement about physical, sexual and economic IPV during pregnancy was high with 86\u201393% of couples reporting concordantly. Also, men\u2019s self-reported perpetration had statistically significant associations with at least as many validated risk factors as had women\u2019s self-reported victimization. This finding suggests that men\u2019s self-reports are at least as valid as women\u2019s as an indicator of IPV against women in Northern Tanzania. We recommend more validation studies are conducted in low-income countries, and that data on relationship factors affecting IPV reports and reporting are made available along with data on IPV occurrences. Keywords: Intimate partner violence; measurement; validity; survey research; Tanzania.In recent years, major global institutions have amplified their efforts to address intimate partner violence (IPV) against women\u2014a global health and human rights violation affecting 15\u201371% of reproductive aged women over their lifetimes. Still, some scholars remain concerned about the validity of instruments used for IPV assessment in population-based studies. In this paper, we conducted two validation analyses using novel data from 450 women-men dyads across nine villages in Northern Tanzania.  Intimate partner violence (IPV) is a global health and human rights problem affecting 15\u201371% of reproductive-aged women worldwide over their lifetime. DefinedRecently, IPV has evolved into an important area of intervention and investigation among practitioners and academics. Major global health and development organizations have escalated their commitment to address IPV in low-income countries. For example, since 2013, the United States\u2019 (USAID and the Department of State) support for global gender-based violence (GBV) programs totaled approximately $153 million per year . During and the perpetrator, scholars showed poor inter-partner agreement in IPV reporting. Regardless of gender, victims report up to 50% more IPV occurrences than perpetrators, depending on context [However, some scholars remain concerned about the validity of instruments used for IPV assessment, questioning whether IPV instruments are effective in accurately classifying women as exposed or not exposed to IPV \u201316. Data context \u201320.First, we examined the level of inter-partner agreement in the reporting of physical, sexual, emotional and economic IPV against women in the last three and twelve months prior to the survey, ever in the relationship, or during pregnancy, using novel data from 450 couples across nine villages in Northern Tanzania. Second, we conducted a convergent validity analysis to compare the relative efficacy of men\u2019s self-reported perpetration and women\u2019s self-reported victimization as a valid indicator of IPV against women in Tanzania. Using logistic regression models, we examined whether and to what extent male and female partners\u2019 IPV self-reports were associated with men\u2019s self-reports on validated risk IPV factors, namely, men\u2019s inequitable attitudes about gender norms and relations, traumatic childhood experience, condom non-use, multiple sexual partners, and substance use.In this paper, we conducted two validation analyses. This study makes important contributions to IPV research in low-income countries. First, since self-reports will dominate IPV research for years to come , rates oGender-based stratification is a central feature of society in Tanzania, an East African country with an estimated population of 47.4 million and per capita income of $865 . With a Discordant reporting of IPV by couples occurs when (a) the man reports no violence perpetration, but the woman reports victimization : Cell 2;Scholars attribute couples\u2019 discordant reporting to a number of social and methodological factors. Social factors include social desirability and norms of victim blaming , 30. MetSocial desirability is often considered a determinant of couples\u2019 discordant reporting and perpetrators\u2019 under-reporting of IPV , 21. DefIn Tanzania, social desirability will likely produce couples\u2019 discordant men-to-women IPV reporting in the form portrayed in Cell 3 more commonly than that in Cell 2 . As statConversely, Tanzanian women may not disclose victimization fearing blame, shame, divorce, abandonment, and loss of the custody of children. McCleary-Sills and colleagues (2016) explain, \u201c\u2026 at the core of this is a sense that women are at fault for any violence they experience because they have somehow provoked their partners into beating them\u201d (p. 229). Women fOn methodological factors, couples\u2019 discordant IPV reporting may be attributable to definitional differences. A difficult construct to operationalize, IPV tends to be private  and subjective . Men\u2019s knowledge about what is or is not IPV may be lower than women\u2019s, creating discordant reporting of IPV. Such gender gaps may exist because men only recently started participating in violence prevention programs , whereas women\u2019s participation in such programs has been ongoing for many years .Finally, couples\u2019 discordant IPV reporting may stem from questionnaire design and implementation . Men andFor convergent validation analysis, the IPV risk factors considered include men\u2019s inequitable gender attitudes; exposure to childhood trauma; multiple sexual partners; condom non-use; and alcohol or drug use. Support in prior literature informed inclusion of these IPV risk factors.Men\u2019s excessive alcohol consumption is associated with IPV against women. Working as a trigger, alcohol influences violence by disinhibiting behavior in individuals with aggressive tendencies and encouraging sexual-risk taking , which may lead to jealousy, perceptions of partners\u2019 infidelity, transmission of sexually transmitted infections, and marital conflict and violence , 46. MenChildhood exposure to traumatic experiences, especially when untreated, can influence individuals\u2019 violent treatment of others later in life , 57. ChiFinally, men\u2019s IPV perpetration is believed to be a consequence of the gender system that entitles men to more rights, privileges and power, resulting in gender inequalities at the societal and relational levels. This inequality limits women\u2019s educational attainment and wage employment, leading to women\u2019s economic dependence on men and vulnerability to and acceptance of male control and abuse of power , 64, andKaratu District, one of seven districts in the Arusha region of Tanzania. Our selection of this region and district was based on the high prevalence (>1 in 3) and acceptance (1 in 3) of IPV in Arusha (NBS & ICF Macro 2016), as well as the implementation of an ongoing savings groups (known as LIMCA) with women implemented by our partner, World Education Inc./Bantwana. These groups aimed to empower women participants through savings and credit activities to increase their economic independence and expand social networks. The groups also aimed to improve women\u2019s knowledge about the physical, mental and emotional harms of IPV on women, men and children.For this analysis, we used the baseline survey data from 450 couples who participated in a three-arm cluster-randomized controlled trial (RCT) to evaluate the effectiveness of an intervention (entitled Together to End Violence against Women (TEVAW)) in reducing men\u2019s IPV perpetration in Tanzania. We conducted this cluster-RCT in We recruited a non-probability sample of 450 of 604 women LIMCA members and their male partners. Women LIMCA members were briefed about the study during regular LIMCA meetings. We invited women-men dyads who were eligible. Eligibility criteria for women included being aged 18 years or above, living with a male partner, providing written consent to participate in the study and consents in writing to her male partner to participate. Eligibility criteria for men included being aged 18 year or above, living with a woman LIMCA group member, and providing written consent to participate in the study. We included in the study the first 450 men-women dyads deemed eligible. Baseline data were collected in June-July 2015 via face-to-face interviews. Women and men were interviewed separately in a private location by trained interviewers of the same gender. Ethical approval was obtained from Boston University and the Tanzania National Institute of Medical Research Institutional Review Boards.For IPV by type, we adopted questions from three instruments: Men\u2019s Health and Relationship Study , WHO MulWe created a dummy variable of whether a man (woman) had perpetrated (been victimized of) IPV against women. We considered that a man had perpetrated physical violence against his female partner in last three months, last 12 months, ever in the relationship, and during pregnancy if, for each of these time intervals, he reported perpetrating once, a few times or many times any one of the following: slapped a partner or thrown something at her that could hurt her; pushed or shoved a partner; hit a partner with a fist or with something else that could hurt her; kicked, dragged, beaten, choked or burned a partner; or threatened to use or actually used a gun, knife or other weapon against a partner. We considered that a woman had experienced physical violence from her male partner if she reported experiencing once, a few times or many times any one of these acts. The same parameters were used for men\u2019s perpetration and women\u2019s experience in the four time points mentioned of the following acts of sexual violence , emotional violence , and economic violence . Questions on physical, sexual, or economic IPV during pregnancy were about victimization of any acts of physical, sexual or economic IPV during any pregnancy.Gender inequitable attitudes was measured using an 18-item scale on attitudes toward gender norms in intimate relationships, known as the GEM (Gender Equitable Men) Scale . For eacExposure to childhood trauma was measured using a 13-item scale, a modified version of the Child Trauma Questionnaire . For eacCondom non-use was measured using men\u2019s reports on how often  they used condoms when having sex in the last year. On condom non-use, men received the value of 1 if they reported never; else, they received a zero. Multiple sexual partners was measured using men\u2019s reports on the question: \u201cIncluding stable partners and occasional partners, how many people have you had sex with in the last year?\u201d Options include: 1 person; 2 or 3 people; 4\u201310 people; 11\u201320 people; more than 20 people; and none. Men received 1 if they reported having sex with more than one person within the last year; otherwise, they received a zero. Finally, alcohol or drug use was measured using men\u2019s reports on two questions: \u201cHow often do you drink alcohol?\u201d and \u201cHow many times have you used drugs in the last 12 months?\u201d For both questions, options include: every day or nearly every day; weekly; once a month; less than once a month; and never. Men received a zero if they reported never on both questions; otherwise, they received a one.Finally, male and female partners\u2019 age was measured with self-reported age in years; highest level of schooling attended was measured using self-reports.We estimated the crude percentage agreements and chance-corrected agreements between couples\u2019 reports of physical, sexual, emotional, and economic violence in the last three and twelve months prior to the survey, ever in the relationship, and during pregnancy. We cross-tabulated men\u2019s reports (Yes/No) of physical, sexual, emotional and economic violence perpetration in the last three and twelve months prior to the survey, ever in the relationship, and during pregnancy and women\u2019s reports (Yes/No) of victimization. Further, we estimated the chance-corrected agreements between couples\u2019 reports of each of the 48 violent events considered in the analysis (see Measures).Next, for convergent validity analysis, we estimated the following equation:ii. Y is 1 if the log odds of reporting IPV by men or women iX refers to risk factors for IPV perpetration, namely, men\u2019s gender inequitable attitudes, exposure to childhood trauma, condom non-use, multiple sexual partners, and alcohol or drug use; iM refers to men\u2019s age and highest level of education attained; and, iW refers to women\u2019s age and highest level of education attained. We fit a logistic regression model with village-level clustered errors, controlling for male and female partners\u2019 age and highest level of education attained.kappa) between couples\u2019 reports of IPV in last three months were low ranging between 0.04  and 0.09 ; kappa estimates for couples\u2019 reports of IPV in the last twelve months and ever in the relationship were also low ranging between 0.06  and 0.18  and between 0.02  and 0.17 (economic IPV), respectively.For every violence type across the recall periods of last three months, last twelve months and ever in the relationship, at least one in three couples disagreed about IPV occurrences in the relationship  and 14% (economic IPV)  between couples\u2019 reports of men-to-women perpetration of each of the 48 acts of IPV considered in this analysis. The kappa estimates were low: for physical IPV acts, these estimates ranged between -0.01 and 0.03, 0.02 and 0.19 and 0.03 and 0.14 for last three months, twelve months and ever in the relationship, respectively; for sexual IPV acts, these estimates ranged between -0.02 and 0.06, 0.03 and 0.09, and 0.01 and 0.05 for last three months, twelve months and ever in the relationship, respectively; for emotional IPV acts, these estimates ranged between 0.01 and 0.07, 0.03 and 0.12, and -0.04 and 0.12 for last three months, twelve months and ever in the relationship, respectively; and, finally, for economic IPV acts, these estimates ranged between 0.05 and 0.14, 0.08 and 0.14, and 0.09 and 0.18 for last three months, twelve months and ever in the relationship, respectively.Finally, in or women (Block 3) were 15\u201345% higher than those estimated using women\u2019s reports (Block 2); 76\u2013308% higher than those estimated using men\u2019s (Block 1). Prevalence rates estimated using reports by men and women (Block 3) were 51\u201387% lower than those estimated using women\u2019s reports (Block 2), and 27\u201360% lower than those estimated using men\u2019s reports (Block 1).Of five IPV risk factors, three  had significant associations with men\u2019s self-reported physical IPV perpetration in the last three months ; and, three  had associations with women\u2019s self-reported victimization (Panel 1: Model 2). The magnitudes of association were relatively small; directions generally were as expected. Men\u2019s odds (aOR = 1.10) of reporting perpetration increased with a unit increase in their childhood-trauma scores. Alcohol or drug users had higher odds (aOR = 2.01) than non-users; condom non-users (aOR = 0.55) had lower odds than users. Next, men who reported agreement with more gender-inequitable attitudes had higher odds (aOR = 1.05) of being reported as perpetrators by their female partners. The same pattern of association was evident for men who experienced more trauma during childhood (aOR = 1.08). Finally, alcohol or drug users had higher odds (aOR = 1.65) of being reported as perpetrators compared to non-users.Of five IPV risk factors, two  had significant associations with men\u2019s self-reported sexual IPV perpetration ; none had associations with women\u2019s self-reported victimization (Panel 2: Model 2). Men who reported multiple sexual partners were three times more likely to report sexual IPV perpetration than men who reported one or none. Men who reported alcohol or drug use had higher odds (aOR = 1.56) than men who reported non-use.On emotional IPV (Panel 3), three  of five IPV risk factors had significant associations with men\u2019s self-reported perpetration (Model 1); one  had an association with women\u2019s self-reported victimization (Model 2). Men who reported more traumatic childhood had higher odds (aOR = 1.18) of reporting perpetration. Condom non-users had lower odds (aOR = 0.56) than users; alcohol or drug users had higher odds (aOR = 2.77) than non-users. Further, alcohol or drug users had higher odds (aOR = 1.62) of being reported as perpetrators by women than non-users.On economic IPV (Panel 4), four  of five IPV risk factors, had significant associations with men\u2019s self-reported perpetration (Model 1); one  was associated with women\u2019s self-reported victimization (Model 2). Men who reported agreement with more gender-inequitable attitudes (aOR = 1.06) and more childhood-trauma (aOR = 1.12) had higher odds of reporting perpetration. Condom non-users had lower odds (OR = 0.54) than users; alcohol or drug users had had higher odds (OR = 2.20) than non-users. Further, alcohol or drug users had higher odds (aOR = 1.44) of being reported as perpetrators by their female partners.or economic IPV perpetration in the last three months (Model 1). None had associations with women\u2019s odds of reporting victimization (Model 2).All five IPV risk factors (Panel 5) had significant associations with men\u2019s odds of reporting of physical, sexual, emotional Further, we estimated associations with five IPV risk factors of IPV occurrences reported by men or women (Model 3) and by both men and women (Model 4). Of five IPV risk factors, four  were associated with physical IPV, none with sexual IPV, three with emotional IPV , two each with economic IPV  and any one form of IPV , when IPV against women was measured using IPV occurrences reported by men or women (Model 3). Additionally, of five IPV risk factors, two  were associated with physical IPV, one (childhood trauma) with sexual IPV, three  with emotional IPV, two  with economic IPV, and three  with any one form of IPV, when IPV against women was measured using IPV occurrences reported by both men and women (Model 4).and the perpetrator are believed to mitigate reporting biases .In recent years, the Government of Tanzania has amplified its effort to redress the consequences faced by the victims of intimate partner violence in the country. These efforts, albeit important, may become those of limited impact if assessment tools are neither specific nor sensitive in correctly classifying women as victims or otherwise. Self-reports by the victim are commonly used for IPV assessment. Yet, self-reports are prone to reporting bias. The validity of self-reports by the victim is contingent on victims recognizing an act as violent as and when it happens, remembering when violence occurs in the relationship, and not concealing violence. Self-reports by the victim In this paper, using data from 450 Tanzania couples, we examined the level of inter-partner agreement in the reporting of physical, sexual, emotional, and economic IPV against women in the last three months prior to the survey, last twelve months, ever in the relationship, and during pregnancy. Further, we examined the relative association of men\u2019s self-reported perpetration and women\u2019s self-reported victimization with validated risk factors, namely, men\u2019s gender inequitable attitudes, exposure to childhood trauma, condom non-use, multiple sexual partners, and alcohol or drug use. We used men\u2019s self-reports to measure risk factors.In IPV reporting, we found poor agreement between partners within the couple in Northern Tanzania. We found that, for every violence type across the recall periods of last three months, last twelve months and ever in the relationship, at least one in three couples disagreed about IPV occurrences in the relationship. The level of partner disagreement in the reporting of lifetime physical IPV in the current analysis (42%) is comparable to findings (35%) by Yount and Li (2012) using the 1995\u201396 and 1996\u201397 DHS data from 943 randomly selected couples from Assiut and Souhag, Egypt .prima facie support to our argument. Norms of victim blaming should similarly affect IPV reporting by women LIMCA members and their male partners, and cannot explain discordant reporting. Social desirability bias is less likely to be a factor: gendered motivation to conceal or disclose IPV occurrences are likely slim in the gender-stratified context of Northern Tanzania, where IPV is perceived as normal and met with acceptance by both genders. That the extent of couple disagreement remains comparable across the recall periods of last three months, last twelve months is suggestive of the fact that men and women were equally prone to recall bias.We argue that, in the context of Northern Tanzania, definitional differences have contributed to discordant reporting more than norms of victim blaming, social desirability, or recall bias. Compared to women LIMCA members trained in child protection and gender-based violence, men may be less capable of recognizing acts as those of violence due to training gaps, potentially resulting from men\u2019s non-participation in any structured IPV training. That the level of couple disagreement is higher in the reporting of emotional violence (48%) than it is in the reporting of physical violence (36%) provides some A vast majority of couples agreed that physical (92%), sexual (93%), and economic (85%) abuse did not occur during pregnancy. Such high concordance rates were contrary to expectation, given language ambiguity in the questions of interest. These questions do not ask about abuse in reference to a specific pregnancy, requiring each partner in the couple of multiple pregnancies to decide for him/herself which pregnancy to recall in his/her answer. Specifying pregnancies in questions about abuse during pregnancy will further improve data quality.Convergent validity findings via logistic regression models with village-level clustered errors were somewhat contrary to expectation. Compared to women\u2019s self-reports, men\u2019s had significant associations with at least as many IPV risk factors. This implies that men\u2019s self-reports are as valid as women\u2019s self-reports as an indicator of men\u2019s perpetration of physical IPV against women, and more valid than women\u2019s self-reports as an indicator of men\u2019s perpetration of sexual, emotional, and economic IPV in the context of Northern Tanzania.Further, validation findings suggest that some women may have reported sexual, emotional, or economic IPV when there were none. Over-reporting  may steThe validation analysis results should be interpreted in light of the limitations as follows. The sample of 450 couples was not randomly selected, suggesting current results may or may not be generalizable to all couples whose female partners are engaged in income-generating activities in Tanzania. Further, more importantly, we used men\u2019s self-reports to measure all five risk factors for IPV perpetration in men. Therefore, the unbiasedness of validation results are conditional on five risk factors being: (a) true risks in the context of Tanzania; and, (b) free of measurement errors. Future studies should replicate current analyses using different data.In conclusion, the use of retrospective self-report questionnaires has revolutionized the way we collect data on violence perpetration and victimization, allowing production of a great deal of knowledge about the causes and consequences of interpersonal violence against women. However, the lone use of retrospective self-reports is believed to have created controversies . Research attempting to resolve these controversies, as part of research on the operationalization of IPV, is more prevalent in high- vs. low-income countries. We recommend this gap be addressed urgently. In the meantime, researchers and practitioners may modify current data-collection practices in low-income countries. For instance, in addition to collecting data on IPV occurrence, researchers and practitioners should collect data on factors affecting the quality of IPV reports and reporting. These factors include: satisfaction level, a desire to exact revenge for prior mistreatment, the degree of investment in the relationship, among other relationship factors. Valid assessment is imperative to mitigating IPV adversities on maternal and child health.S1 Dataset(ZIP)Click here for additional data file.", "texts": ["First, we examined the level of inter-partner agreement in reporting of men\u2019s physical, sexual, emotional and economic IPV against women in the last three and twelve months prior to the survey, ever in the relationship, and during pregnancy. Second, we conducted a convergent validity analysis to compare the relative efficacy of men\u2019s self-reports of perpetration and women\u2019s of victimization as a valid indicator of IPV against Tanzanian women using logistic regression models with village-level clustered errors. We found that, for every violence type across the recall periods of the last three months, the last twelve months and ever in the relationship, at least one in three couples disagreed about IPV occurrences in the relationship. Couples\u2019 agreement about physical, sexual and economic IPV during pregnancy was high with 86\u201393% of couples reporting concordantly. Also, men\u2019s self-reported perpetration had statistically significant associations with at least as many validated risk factors as had women\u2019s self-reported victimization. This finding suggests that men\u2019s self-reports are at least as valid as women\u2019s as an indicator of IPV against women in Northern Tanzania. We recommend more validation studies are conducted in low-income countries, and that data on relationship factors affecting IPV reports and reporting are made available along with data on IPV occurrences. Keywords: Intimate partner violence; measurement; validity; survey research; Tanzania.In recent years, major global institutions have amplified their efforts to address intimate partner violence (IPV) against women\u2014a global health and human rights violation affecting 15\u201371% of reproductive aged women over their lifetimes. Still, some scholars remain concerned about the validity of instruments used for IPV assessment in population-based studies. In this paper, we conducted two validation analyses using novel data from 450 women-men dyads across nine villages in Northern Tanzania.  Intimate partner violence (IPV) is a global health and human rights problem affecting 15\u201371% of reproductive-aged women worldwide over their lifetime. DefinedRecently, IPV has evolved into an important area of intervention and investigation among practitioners and academics. Major global health and development organizations have escalated their commitment to address IPV in low-income countries. For example, since 2013, the United States\u2019 (USAID and the Department of State) support for global gender-based violence (GBV) programs totaled approximately $153 million per year . During and the perpetrator, scholars showed poor inter-partner agreement in IPV reporting. Regardless of gender, victims report up to 50% more IPV occurrences than perpetrators, depending on context [However, some scholars remain concerned about the validity of instruments used for IPV assessment, questioning whether IPV instruments are effective in accurately classifying women as exposed or not exposed to IPV \u201316. Data context \u201320.First, we examined the level of inter-partner agreement in the reporting of physical, sexual, emotional and economic IPV against women in the last three and twelve months prior to the survey, ever in the relationship, or during pregnancy, using novel data from 450 couples across nine villages in Northern Tanzania. Second, we conducted a convergent validity analysis to compare the relative efficacy of men\u2019s self-reported perpetration and women\u2019s self-reported victimization as a valid indicator of IPV against women in Tanzania. Using logistic regression models, we examined whether and to what extent male and female partners\u2019 IPV self-reports were associated with men\u2019s self-reports on validated risk IPV factors, namely, men\u2019s inequitable attitudes about gender norms and relations, traumatic childhood experience, condom non-use, multiple sexual partners, and substance use.In this paper, we conducted two validation analyses. This study makes important contributions to IPV research in low-income countries. First, since self-reports will dominate IPV research for years to come , rates oGender-based stratification is a central feature of society in Tanzania, an East African country with an estimated population of 47.4 million and per capita income of $865 . With a Discordant reporting of IPV by couples occurs when (a) the man reports no violence perpetration, but the woman reports victimization : Cell 2;Scholars attribute couples\u2019 discordant reporting to a number of social and methodological factors. Social factors include social desirability and norms of victim blaming , 30. MetSocial desirability is often considered a determinant of couples\u2019 discordant reporting and perpetrators\u2019 under-reporting of IPV , 21. DefIn Tanzania, social desirability will likely produce couples\u2019 discordant men-to-women IPV reporting in the form portrayed in Cell 3 more commonly than that in Cell 2 . As statConversely, Tanzanian women may not disclose victimization fearing blame, shame, divorce, abandonment, and loss of the custody of children. McCleary-Sills and colleagues (2016) explain, \u201c\u2026 at the core of this is a sense that women are at fault for any violence they experience because they have somehow provoked their partners into beating them\u201d (p. 229). Women fOn methodological factors, couples\u2019 discordant IPV reporting may be attributable to definitional differences. A difficult construct to operationalize, IPV tends to be private  and subjective . Men\u2019s knowledge about what is or is not IPV may be lower than women\u2019s, creating discordant reporting of IPV. Such gender gaps may exist because men only recently started participating in violence prevention programs , whereas women\u2019s participation in such programs has been ongoing for many years .Finally, couples\u2019 discordant IPV reporting may stem from questionnaire design and implementation . Men andFor convergent validation analysis, the IPV risk factors considered include men\u2019s inequitable gender attitudes; exposure to childhood trauma; multiple sexual partners; condom non-use; and alcohol or drug use. Support in prior literature informed inclusion of these IPV risk factors.Men\u2019s excessive alcohol consumption is associated with IPV against women. Working as a trigger, alcohol influences violence by disinhibiting behavior in individuals with aggressive tendencies and encouraging sexual-risk taking , which may lead to jealousy, perceptions of partners\u2019 infidelity, transmission of sexually transmitted infections, and marital conflict and violence , 46. MenChildhood exposure to traumatic experiences, especially when untreated, can influence individuals\u2019 violent treatment of others later in life , 57. ChiFinally, men\u2019s IPV perpetration is believed to be a consequence of the gender system that entitles men to more rights, privileges and power, resulting in gender inequalities at the societal and relational levels. This inequality limits women\u2019s educational attainment and wage employment, leading to women\u2019s economic dependence on men and vulnerability to and acceptance of male control and abuse of power , 64, andKaratu District, one of seven districts in the Arusha region of Tanzania. Our selection of this region and district was based on the high prevalence (>1 in 3) and acceptance (1 in 3) of IPV in Arusha (NBS & ICF Macro 2016), as well as the implementation of an ongoing savings groups (known as LIMCA) with women implemented by our partner, World Education Inc./Bantwana. These groups aimed to empower women participants through savings and credit activities to increase their economic independence and expand social networks. The groups also aimed to improve women\u2019s knowledge about the physical, mental and emotional harms of IPV on women, men and children.For this analysis, we used the baseline survey data from 450 couples who participated in a three-arm cluster-randomized controlled trial (RCT) to evaluate the effectiveness of an intervention (entitled Together to End Violence against Women (TEVAW)) in reducing men\u2019s IPV perpetration in Tanzania. We conducted this cluster-RCT in We recruited a non-probability sample of 450 of 604 women LIMCA members and their male partners. Women LIMCA members were briefed about the study during regular LIMCA meetings. We invited women-men dyads who were eligible. Eligibility criteria for women included being aged 18 years or above, living with a male partner, providing written consent to participate in the study and consents in writing to her male partner to participate. Eligibility criteria for men included being aged 18 year or above, living with a woman LIMCA group member, and providing written consent to participate in the study. We included in the study the first 450 men-women dyads deemed eligible. Baseline data were collected in June-July 2015 via face-to-face interviews. Women and men were interviewed separately in a private location by trained interviewers of the same gender. Ethical approval was obtained from Boston University and the Tanzania National Institute of Medical Research Institutional Review Boards.For IPV by type, we adopted questions from three instruments: Men\u2019s Health and Relationship Study , WHO MulWe created a dummy variable of whether a man (woman) had perpetrated (been victimized of) IPV against women. We considered that a man had perpetrated physical violence against his female partner in last three months, last 12 months, ever in the relationship, and during pregnancy if, for each of these time intervals, he reported perpetrating once, a few times or many times any one of the following: slapped a partner or thrown something at her that could hurt her; pushed or shoved a partner; hit a partner with a fist or with something else that could hurt her; kicked, dragged, beaten, choked or burned a partner; or threatened to use or actually used a gun, knife or other weapon against a partner. We considered that a woman had experienced physical violence from her male partner if she reported experiencing once, a few times or many times any one of these acts. The same parameters were used for men\u2019s perpetration and women\u2019s experience in the four time points mentioned of the following acts of sexual violence , emotional violence , and economic violence . Questions on physical, sexual, or economic IPV during pregnancy were about victimization of any acts of physical, sexual or economic IPV during any pregnancy.Gender inequitable attitudes was measured using an 18-item scale on attitudes toward gender norms in intimate relationships, known as the GEM (Gender Equitable Men) Scale . For eacExposure to childhood trauma was measured using a 13-item scale, a modified version of the Child Trauma Questionnaire . For eacCondom non-use was measured using men\u2019s reports on how often  they used condoms when having sex in the last year. On condom non-use, men received the value of 1 if they reported never; else, they received a zero. Multiple sexual partners was measured using men\u2019s reports on the question: \u201cIncluding stable partners and occasional partners, how many people have you had sex with in the last year?\u201d Options include: 1 person; 2 or 3 people; 4\u201310 people; 11\u201320 people; more than 20 people; and none. Men received 1 if they reported having sex with more than one person within the last year; otherwise, they received a zero. Finally, alcohol or drug use was measured using men\u2019s reports on two questions: \u201cHow often do you drink alcohol?\u201d and \u201cHow many times have you used drugs in the last 12 months?\u201d For both questions, options include: every day or nearly every day; weekly; once a month; less than once a month; and never. Men received a zero if they reported never on both questions; otherwise, they received a one.Finally, male and female partners\u2019 age was measured with self-reported age in years; highest level of schooling attended was measured using self-reports.We estimated the crude percentage agreements and chance-corrected agreements between couples\u2019 reports of physical, sexual, emotional, and economic violence in the last three and twelve months prior to the survey, ever in the relationship, and during pregnancy. We cross-tabulated men\u2019s reports (Yes/No) of physical, sexual, emotional and economic violence perpetration in the last three and twelve months prior to the survey, ever in the relationship, and during pregnancy and women\u2019s reports (Yes/No) of victimization. Further, we estimated the chance-corrected agreements between couples\u2019 reports of each of the 48 violent events considered in the analysis (see Measures).Next, for convergent validity analysis, we estimated the following equation:ii. Y is 1 if the log odds of reporting IPV by men or women iX refers to risk factors for IPV perpetration, namely, men\u2019s gender inequitable attitudes, exposure to childhood trauma, condom non-use, multiple sexual partners, and alcohol or drug use; iM refers to men\u2019s age and highest level of education attained; and, iW refers to women\u2019s age and highest level of education attained. We fit a logistic regression model with village-level clustered errors, controlling for male and female partners\u2019 age and highest level of education attained.kappa) between couples\u2019 reports of IPV in last three months were low ranging between 0.04  and 0.09 ; kappa estimates for couples\u2019 reports of IPV in the last twelve months and ever in the relationship were also low ranging between 0.06  and 0.18  and between 0.02  and 0.17 (economic IPV), respectively.For every violence type across the recall periods of last three months, last twelve months and ever in the relationship, at least one in three couples disagreed about IPV occurrences in the relationship  and 14% (economic IPV)  between couples\u2019 reports of men-to-women perpetration of each of the 48 acts of IPV considered in this analysis. The kappa estimates were low: for physical IPV acts, these estimates ranged between -0.01 and 0.03, 0.02 and 0.19 and 0.03 and 0.14 for last three months, twelve months and ever in the relationship, respectively; for sexual IPV acts, these estimates ranged between -0.02 and 0.06, 0.03 and 0.09, and 0.01 and 0.05 for last three months, twelve months and ever in the relationship, respectively; for emotional IPV acts, these estimates ranged between 0.01 and 0.07, 0.03 and 0.12, and -0.04 and 0.12 for last three months, twelve months and ever in the relationship, respectively; and, finally, for economic IPV acts, these estimates ranged between 0.05 and 0.14, 0.08 and 0.14, and 0.09 and 0.18 for last three months, twelve months and ever in the relationship, respectively.Finally, in or women (Block 3) were 15\u201345% higher than those estimated using women\u2019s reports (Block 2); 76\u2013308% higher than those estimated using men\u2019s (Block 1). Prevalence rates estimated using reports by men and women (Block 3) were 51\u201387% lower than those estimated using women\u2019s reports (Block 2), and 27\u201360% lower than those estimated using men\u2019s reports (Block 1).Of five IPV risk factors, three  had significant associations with men\u2019s self-reported physical IPV perpetration in the last three months ; and, three  had associations with women\u2019s self-reported victimization (Panel 1: Model 2). The magnitudes of association were relatively small; directions generally were as expected. Men\u2019s odds (aOR = 1.10) of reporting perpetration increased with a unit increase in their childhood-trauma scores. Alcohol or drug users had higher odds (aOR = 2.01) than non-users; condom non-users (aOR = 0.55) had lower odds than users. Next, men who reported agreement with more gender-inequitable attitudes had higher odds (aOR = 1.05) of being reported as perpetrators by their female partners. The same pattern of association was evident for men who experienced more trauma during childhood (aOR = 1.08). Finally, alcohol or drug users had higher odds (aOR = 1.65) of being reported as perpetrators compared to non-users.Of five IPV risk factors, two  had significant associations with men\u2019s self-reported sexual IPV perpetration ; none had associations with women\u2019s self-reported victimization (Panel 2: Model 2). Men who reported multiple sexual partners were three times more likely to report sexual IPV perpetration than men who reported one or none. Men who reported alcohol or drug use had higher odds (aOR = 1.56) than men who reported non-use.On emotional IPV (Panel 3), three  of five IPV risk factors had significant associations with men\u2019s self-reported perpetration (Model 1); one  had an association with women\u2019s self-reported victimization (Model 2). Men who reported more traumatic childhood had higher odds (aOR = 1.18) of reporting perpetration. Condom non-users had lower odds (aOR = 0.56) than users; alcohol or drug users had higher odds (aOR = 2.77) than non-users. Further, alcohol or drug users had higher odds (aOR = 1.62) of being reported as perpetrators by women than non-users.On economic IPV (Panel 4), four  of five IPV risk factors, had significant associations with men\u2019s self-reported perpetration (Model 1); one  was associated with women\u2019s self-reported victimization (Model 2). Men who reported agreement with more gender-inequitable attitudes (aOR = 1.06) and more childhood-trauma (aOR = 1.12) had higher odds of reporting perpetration. Condom non-users had lower odds (OR = 0.54) than users; alcohol or drug users had had higher odds (OR = 2.20) than non-users. Further, alcohol or drug users had higher odds (aOR = 1.44) of being reported as perpetrators by their female partners.or economic IPV perpetration in the last three months (Model 1). None had associations with women\u2019s odds of reporting victimization (Model 2).All five IPV risk factors (Panel 5) had significant associations with men\u2019s odds of reporting of physical, sexual, emotional Further, we estimated associations with five IPV risk factors of IPV occurrences reported by men or women (Model 3) and by both men and women (Model 4). Of five IPV risk factors, four  were associated with physical IPV, none with sexual IPV, three with emotional IPV , two each with economic IPV  and any one form of IPV , when IPV against women was measured using IPV occurrences reported by men or women (Model 3). Additionally, of five IPV risk factors, two  were associated with physical IPV, one (childhood trauma) with sexual IPV, three  with emotional IPV, two  with economic IPV, and three  with any one form of IPV, when IPV against women was measured using IPV occurrences reported by both men and women (Model 4).and the perpetrator are believed to mitigate reporting biases .In recent years, the Government of Tanzania has amplified its effort to redress the consequences faced by the victims of intimate partner violence in the country. These efforts, albeit important, may become those of limited impact if assessment tools are neither specific nor sensitive in correctly classifying women as victims or otherwise. Self-reports by the victim are commonly used for IPV assessment. Yet, self-reports are prone to reporting bias. The validity of self-reports by the victim is contingent on victims recognizing an act as violent as and when it happens, remembering when violence occurs in the relationship, and not concealing violence. Self-reports by the victim In this paper, using data from 450 Tanzania couples, we examined the level of inter-partner agreement in the reporting of physical, sexual, emotional, and economic IPV against women in the last three months prior to the survey, last twelve months, ever in the relationship, and during pregnancy. Further, we examined the relative association of men\u2019s self-reported perpetration and women\u2019s self-reported victimization with validated risk factors, namely, men\u2019s gender inequitable attitudes, exposure to childhood trauma, condom non-use, multiple sexual partners, and alcohol or drug use. We used men\u2019s self-reports to measure risk factors.In IPV reporting, we found poor agreement between partners within the couple in Northern Tanzania. We found that, for every violence type across the recall periods of last three months, last twelve months and ever in the relationship, at least one in three couples disagreed about IPV occurrences in the relationship. The level of partner disagreement in the reporting of lifetime physical IPV in the current analysis (42%) is comparable to findings (35%) by Yount and Li (2012) using the 1995\u201396 and 1996\u201397 DHS data from 943 randomly selected couples from Assiut and Souhag, Egypt .prima facie support to our argument. Norms of victim blaming should similarly affect IPV reporting by women LIMCA members and their male partners, and cannot explain discordant reporting. Social desirability bias is less likely to be a factor: gendered motivation to conceal or disclose IPV occurrences are likely slim in the gender-stratified context of Northern Tanzania, where IPV is perceived as normal and met with acceptance by both genders. That the extent of couple disagreement remains comparable across the recall periods of last three months, last twelve months is suggestive of the fact that men and women were equally prone to recall bias.We argue that, in the context of Northern Tanzania, definitional differences have contributed to discordant reporting more than norms of victim blaming, social desirability, or recall bias. Compared to women LIMCA members trained in child protection and gender-based violence, men may be less capable of recognizing acts as those of violence due to training gaps, potentially resulting from men\u2019s non-participation in any structured IPV training. That the level of couple disagreement is higher in the reporting of emotional violence (48%) than it is in the reporting of physical violence (36%) provides some A vast majority of couples agreed that physical (92%), sexual (93%), and economic (85%) abuse did not occur during pregnancy. Such high concordance rates were contrary to expectation, given language ambiguity in the questions of interest. These questions do not ask about abuse in reference to a specific pregnancy, requiring each partner in the couple of multiple pregnancies to decide for him/herself which pregnancy to recall in his/her answer. Specifying pregnancies in questions about abuse during pregnancy will further improve data quality.Convergent validity findings via logistic regression models with village-level clustered errors were somewhat contrary to expectation. Compared to women\u2019s self-reports, men\u2019s had significant associations with at least as many IPV risk factors. This implies that men\u2019s self-reports are as valid as women\u2019s self-reports as an indicator of men\u2019s perpetration of physical IPV against women, and more valid than women\u2019s self-reports as an indicator of men\u2019s perpetration of sexual, emotional, and economic IPV in the context of Northern Tanzania.Further, validation findings suggest that some women may have reported sexual, emotional, or economic IPV when there were none. Over-reporting  may steThe validation analysis results should be interpreted in light of the limitations as follows. The sample of 450 couples was not randomly selected, suggesting current results may or may not be generalizable to all couples whose female partners are engaged in income-generating activities in Tanzania. Further, more importantly, we used men\u2019s self-reports to measure all five risk factors for IPV perpetration in men. Therefore, the unbiasedness of validation results are conditional on five risk factors being: (a) true risks in the context of Tanzania; and, (b) free of measurement errors. Future studies should replicate current analyses using different data.In conclusion, the use of retrospective self-report questionnaires has revolutionized the way we collect data on violence perpetration and victimization, allowing production of a great deal of knowledge about the causes and consequences of interpersonal violence against women. However, the lone use of retrospective self-reports is believed to have created controversies . Research attempting to resolve these controversies, as part of research on the operationalization of IPV, is more prevalent in high- vs. low-income countries. We recommend this gap be addressed urgently. In the meantime, researchers and practitioners may modify current data-collection practices in low-income countries. For instance, in addition to collecting data on IPV occurrence, researchers and practitioners should collect data on factors affecting the quality of IPV reports and reporting. These factors include: satisfaction level, a desire to exact revenge for prior mistreatment, the degree of investment in the relationship, among other relationship factors. Valid assessment is imperative to mitigating IPV adversities on maternal and child health.S1 Dataset(ZIP)Click here for additional data file."]}
{"representative": "Little research has assessed the impact of emotional intimate partner violence (IPV) and economic IPV on women\u2019s mental health. Using cross-sectional data from the Stepping Stones and Creating Futures intervention trial baseline, in eThekwini Municipality, South Africa we assess three questions. First, whether emotional IPV and economic IPV make independent contributions to mental health outcomes; second what matters, severity, variety, or absolute experience? and third, are some items more important in driving mental health impacts than others? We assess associations between past 12-month emotional IPV, past 12-month economic IPV, and past week depressive symptoms and past four-week suicidal ideation. We describe the prevalence of each mental health outcome by individual items, including never/ever and frequency, and combined emotional IPV, and economic IPV, reporting depression scores and percentage of suicidal ideation and 95% confidence intervals (CI). Second, we created four-level categorical variables for combinations of emotional, economic, sexual and physical IPV, and present its frequency, and the mean/% and 95% CI for depression symptomatology and suicidal ideation. 680 women (aged 18\u201330) were enrolled. High levels of past year emotional IPV, economic IPV were reported. 45.3% reported clinically relevant symptoms of depression, and 30.0% past four-week suicidal ideation. All measures of emotional IPV and economic IPV showed a consistent positive correlation with CESD scores, and suicidal ideation. For all four-level categorical constructs the highest depression scores, and prevalence of suicidal ideation, were for combinations of emotional IPV or economic IPV with physical and/or sexual IPV. For depression in 17/18 combinations this was significantly different compared to women reporting no IPV. For suicidal ideation this was significant in 6/18 combinations all related to economic IPV. Emotional IPV and economic IPV have independent associations with women\u2019s mental health, beyond physical IPV and sexual IPV, and also have distinct patterns between each other.NCT03022370. Registered 13 January 2017, retrospectively registered. A decrease in emotional intimate partner violence (IPV) is now an indicator of progress for the Sustainable Development Goal 5.2. This indicator is one of 230 indicators assessing progress on the 17 global goals established by the UN to assess development progress by 2030 . The lacThe lack of focus on emotional and economic IPV in research to date emerges for a number of reasons. First, there is a lack of consensus on best practices for measuring these constructs, which can manifest in myriad and culturally diverse ways e.g. , 8, in cFinally, there is also a lack of conceptual clarity about what constitutes emotional IPV and economic IPV. For emotional IPV, this is apparent in the multitude of terms for the same or similar phenomena, including psychological violence, or abuse. For clarity and a working definition in this paper, emotional IPV includes verbal abuse and humiliation, and threats of violence or other acts to scare a woman . While eThere is emerging evidence that the view that emotional and economic IPV have less health impact than physical or sexual IPV may be wrong. A review of research on IPV and suicide found two studies showing increased suicidal ideation and suicide attempts following emotional IPV, specifically Bangladeshi women were 2\u20133 times more likely to report suicidal ideation if they had experienced emotional IPV . In a loThere are even fewer studies exploring the health impacts of economic IPV, but those that do show that economic IPV also negatively impacts mental health. In Palestine, a nationally representative cross-sectional study showed women who experienced economic IPV were more likely to report depression and anxiety . The natWhile research on health impacts remains limited, it is clear that both economic and emotional IPV are widespread. A systematic review of emotional IPV in pregnancy in Africa estimated that 24.8% to 49% of pregnant African women experienced emotional IPV . In the There are a number of questions about how best to define and measure emotional and economic IPV, and no clear standard has yet emerged. The three major international surveys that have measured these constructs show slight, but important, variations. The WHO Multi-Country Study on Domestic Violence (WHO MCS), and the UN Multi-Country Study on Men and Violence in Asia and the Pacific (UNMCS) and the current Domestic Violence Module (Jan 2017) of the Demographic Health Survey (DHS) vary in the number of items used, and the focus and wording of questions .Just as there is no consensus on the measurement of emotional and economic IPV, there is likewise no consensus on coding and analysis of responses to questionnaire items; this creates further complexities in understanding the prevalence and unique health impacts of these constructs. Some studies treat emotional and economic IPV as separate constructs, while others treat it as one construct \u201321. FurtIn this paper, we argue that through looking at the health impact of emotional IPV, and economic IPV, juxtaposed with the impact of physical and sexual IPV, we can begin to answer many of the central questions in the measurement of emotional and economic IPV. Building this understanding is important for understanding the relative health impact of different forms of IPV, developing and evaluating IPV prevention interventions, and understanding what is most useful to track for monitoring progress towards the SDG. We seek to answer three central questions. First, do economic and emotional IPV, make important, independent contributions to self-reported depressive symptomology and suicidal ideation? Second, if they are important, what matters in their measurement? Is it the number of types, number of episodes, or the overall severity of the IPV? Finally, are some items more important in driving health impacts than other items?Between September 2015 and September 2016, 680 young adult women were recruited to participate in the Stepping Stones and Creating Futures cluster randomized control trial in urban informal settlements surrounding Durban, South Africa. 34 clusters were identified and community leaders approached for inclusion. In each cluster between 19 and 21 women were enrolled into the trial . These aParticipants were aged between 18 and 30 and out of school. Further eligibility criteria included residence in the informal settlement and ability to understand the informed consent process. Participants were not blinded to study arm, those enrolling in the intervention arm received R100 (~US$7) and those in the control arm received R300 (~US$21) for completion of questionnaires. The structured questionnaires were self-completed on cellphones, with built in logic checks and skip patterns. Questionnaires were available in Zulu, Xhosa and English. Research staff matched to the participants by age and gender were available to clarify meaning or assist if literacy or technology posed an issue.Participants provided informed written consent to participate. Ethical approval for the study was received from the University of KwaZulu-Natal, and the South African Medical Research Council. Further details on ethical procedures and research methods are described elsewhere .The content of the questionnaires was almost entirely based on surveys previously used and validated for use in South Africa. Our two key outcomes for this analysis were past week depressive symptomology and past month suicidal ideation.We assessed depressive symptoms using the 20-item The Centre for Epidemiologic Studies Depression Scale (CES-D) scale , which hTo measure past 4 week suicidal ideation, we asked a single item asked whether \u201cthe thought of ending your life been in your mind?\u201d This approach has been used widely to assess suicidal ideation . A binarWe assessed women\u2019s experiences of four types of IPV in the past year: physical, sexual, emotional and economic. Questions on physical IPV were taken from the widely used South African adaption of WHO\u2019s MCS survey . Past yeEmotional IPV in the past year was assessed using the five items from the WHO MCS survey  and adapEconomic IPV was assessed using the four items from the UNMCS survey for women , which wData were uploaded and compiled into a dataset for analysis in Stata IC 14.1. Because of self-completion on cellphones, and inbuilt logic checks, there was very little (<1%) data missing in the sample and no corrections were undertaken for this. Descriptive analyses took into account the clustered nature of the sample, and the 95% confidence intervals (CIs) were calculated using Taylor linearization. Taylor linearization corrects standard errors for the clustered nature of the sample, and provides wider CIs . For eacTo describe associations between the emotional and economic IPV and our chosen mental health outcomes, we first described the prevalence of individual items of emotional IPV and economic IPV. For each item of the emotional and economic IPV scales we report the prevalence of, i) never/ever in the past 12 months, ii) two or more times in the past 12 months versus none or 1, and iii) the frequency of experience . We also report the prevalence of none versus any emotional or economic IPV and two or more versus none or one report of emotional or economic IPV. For each type of IPV described we present the mean and 95% CI for depression scores and the percentage and 95% CI for suicidal ideation.To assess the associations between the four types of IPV exposures and depression/suicidal ideation, we first created a series of four-level categorical variable for a variety of combinations of emotional, economic, sexual and physical IPV and present variation in mental health outcome. For instance, we created a four-level variable for no exposure to violence, one or more emotional IPV exposures only, any emotional IPV and any physical IPV exposure, and physical IPV exposure only. This enabled the creation of \u2018clean\u2019 reference categories for each type of exposure, where typically there is overlap between types of violence that is not accounted for in analyses. We developed different permutations of this violence variable with physical IPV, sexual IPV, economic IPV, combined economic and emotional IPV and then examined if the effects were different if we considered never/ever exposures and higher versus lower frequency of exposure (two or more exposures). For each violence variable we present its frequency and the mean/% and 95% CI for depression symptomatology and suicidal ideation.A total of 680 women were interviewed . Women wAll forms of IPV measured were highly prevalent . Almost Two-thirds (66.5%) of the women reported two or more instances of emotional IPV in in the past year, while just under half (43.7%) reported two or more experiences of economic IPV in the past year. Three-quarters (76.3%) reported two or more experiences of emotional and/or economic IPV in the past year.The mean CES-D score of women in the sample was 21.2. Almost half the sample (45.3%) reported potentially clinically relevant depression (a score of \u2265 21 ), while Tables The most frequently reported form of economic IPV was \u201cyour partner spent money on alcohol, tobacco or other things for himself when he knew you did not have enough for essential household expenses\u201d (38.4%) and the least frequent was taking a woman\u2019s earnings against her will (9.9%) . ApproxiAll measures of emotional and economic IPV we examined showed a consistent positive association with mean CESD-D scores Tables  and 3. FA similar pattern was observed for economic IPV, whereby for all individual items any vs none, and two or more vs none or one comparisons were significantly different with no overlaps of 95% CI. In addition, women reporting many experiences of any individual item had significantly higher depressive symptoms compared to none, while the few category was marginal or non-significant.All measures examined for each of emotional IPV, and economic IPV \u2018full constructrs\u2019  were significantly associated with increased CES-D scores.The overall pattern of associations between emotional IPV, economic IPV, and self-reported suicidal ideation in the last four weeks were similar to those for CES-D scores, but differences were less often significant Tables  and 3. TInteresting differences emerge in looking at the emotional IPV or economic IPV only categories vs the physical and/or sexual IPV only categories. For 15 out of the 18 categorical variables tested, the category of emotional IPV or economic IPV only was associated with higher mean CES-D scores than the category of physical and/or sexual IPV only, the only exception being cases B4-6, looking at multiple events of economic IPV vs multiple events of physical and/or sexual IPV. Cases B4 and B5 also represent the only combinations where physical or sexual violence was significantly different from the no IPV referent, but the variable definition for these cases meant the women who had experience emotional IPV (but not economic) were coded in this group, and so these cases ultimately affirm the importance of emotional IPV as a correlate of CES-D score.This is further affirmed by looking at cases C4-6, which show that the combined category for emotional and/or economic IPV only, associated with significantly higher mean CES-D scores than the categories for physical and/or sexual violence only. Further evidence for the importance of emotional IPV in mean CES-D score is found in case A5, where emotional IPV alone is associated with significantly higher CES-D scores than no IPV .Our analysis clearly highlights the importance of emotional IPV and economic IPV in driving significant mental health impacts for women, and that these extend beyond those found with the current, narrower focus on physical and/or sexual IPV alone. While there is a small, but growing body of research on the health impacts of emotional IPV, and its differential impacts compared to physical and/or sexual IPV , 12, 26,The analysis supports the hypothesis that emotional IPV and economic IPV, have distinct health impacts in themselves. For both economic IPV and emotional IPV the frequency of exposure Tables  and 3 inThere were also differences between the mental health impacts of emotional IPV and economic IPV, despite them being strongly inter-related concepts, they did function as distinctive constructs and should be considered as such. While both emotional IPV and economic IPV had similar patterns around associations with depressive symptomology, there were stronger and more consistent associations between economic IPV and suicidal ideation Tables \u20135, compaThis analysis suggests that emotional IPV and economic IPV should not be regarded as \u2018lighter\u2019 less \u2018important\u2019 forms of IPV when compared to physical and/or sexual IPV, in terms of mental health outcomes. Women in this study who experienced only emotional, or economic IPV reported more depressive symptoms and were more likely to report suicidal ideation than those who experienced physical or sexual IPV only. Major depressive disorders (MDD) for women are common globally, with an estimate past year prevalence of 5.5%, and are associated with increasing death related to physical injuries, self-harm and suicide . MoreoveFinally, the analysis showed that the highest levels of depressive symptoms and prevalence of suicidal ideation, were seen amongst women who experienced emotional IPV or economic IPV, combined with physical IPV or sexual IPV Tables  and 5, sThere are several important implications of the analysis presented here for policy, and for research and evaluation. First, we do not need to measure all forms of emotional IPV and economic IPV to see a mental health impact. The addition of multiple items to questionnaires has often been considered as overly burdensome for studies, and not capturing any distinct impact on women\u2019s health, beyond what has already been captured through assessing physical and sexual IPV. Given the very high prevalence of any emotional IPV and economic IPV and overlaps of types, the returns on measuring additional forms will not yield high returns when viewed in terms of having many more women being \u2018exposed\u2019. As has been shown, emotional IPV and economic IPV have distinct mental health impacts over and above physical and sexual IPV. As such their inclusion is important, but the analysis shows that a relatively small set of items can lead to capturing of these health impacts, particularly when combined with other forms of IPV.Second, we do not need large numbers of indicators in scales to capture health impacts. As shown, measures of ever/never exposures, and in particularly two or more exposures (compared to none or one) capture the majority of mental health impact for women for emotional IPV or economic IPV. As such, it should be possible to derive a smaller sub-set of items that capture the majority of burden that women experience in terms of emotional and economic IPV.Finally, given that emotional IPV and economic IPV have distinctive outcomes in terms of mental health, as well as being clear indicators of severity of impact, when combined with physical and sexual IPV, it is critical that these are included as trial outcomes in interventions seeking to prevent IPV. At a practical level reducing all forms of IPV that have an impact on mental health is crucial, and therefore as emotional IPV and economic IPV have a distinct and separate impact to physical and/or sexual IPV, the impact of interventions on these should be assessed. In addition, other studies have hinted that interventions may have different impacts on different forms of IPV. For instance, an evaluation of Oportunidades in Mexico showed a reduction in physical IPV amongst female recipients, but increases in emotional IPV and increases in threats of violence, however these were not statistically significant .This paper has a number of limitations. First, data is cross-sectional and as such temporality of relationships cannot be ascertained, and there is evidence that the relationship between IPV and depression is bidirectional , 37. SecThe role of emotional IPV and economic IPV in driving health impacts of women is rarely considered, although there is growing interest in emotional IPV, specifically around its consideration as an SDG indicator. The paper clearly highlights that the different forms of IPV  while strongly overlapping also have distinctive health outcomes that need to be considered in research, intervention and policy as such. It is very important that this research is replicated in other datasets and a view on the main findings across multiple settings is reached as this can substantially advance knowledge and understanding of this important area of women\u2019s experience of IPV.S1 Table(DOCX)Click here for additional data file.S1 File(CSV)Click here for additional data file.", "texts": ["Little research has assessed the impact of emotional intimate partner violence (IPV) and economic IPV on women\u2019s mental health. Using cross-sectional data from the Stepping Stones and Creating Futures intervention trial baseline, in eThekwini Municipality, South Africa we assess three questions. First, whether emotional IPV and economic IPV make independent contributions to mental health outcomes; second what matters, severity, variety, or absolute experience? and third, are some items more important in driving mental health impacts than others? We assess associations between past 12-month emotional IPV, past 12-month economic IPV, and past week depressive symptoms and past four-week suicidal ideation. We describe the prevalence of each mental health outcome by individual items, including never/ever and frequency, and combined emotional IPV, and economic IPV, reporting depression scores and percentage of suicidal ideation and 95% confidence intervals (CI). Second, we created four-level categorical variables for combinations of emotional, economic, sexual and physical IPV, and present its frequency, and the mean/% and 95% CI for depression symptomatology and suicidal ideation. 680 women (aged 18\u201330) were enrolled. High levels of past year emotional IPV, economic IPV were reported. 45.3% reported clinically relevant symptoms of depression, and 30.0% past four-week suicidal ideation. All measures of emotional IPV and economic IPV showed a consistent positive correlation with CESD scores, and suicidal ideation. For all four-level categorical constructs the highest depression scores, and prevalence of suicidal ideation, were for combinations of emotional IPV or economic IPV with physical and/or sexual IPV. For depression in 17/18 combinations this was significantly different compared to women reporting no IPV. For suicidal ideation this was significant in 6/18 combinations all related to economic IPV. Emotional IPV and economic IPV have independent associations with women\u2019s mental health, beyond physical IPV and sexual IPV, and also have distinct patterns between each other.NCT03022370. Registered 13 January 2017, retrospectively registered. A decrease in emotional intimate partner violence (IPV) is now an indicator of progress for the Sustainable Development Goal 5.2. This indicator is one of 230 indicators assessing progress on the 17 global goals established by the UN to assess development progress by 2030 . The lacThe lack of focus on emotional and economic IPV in research to date emerges for a number of reasons. First, there is a lack of consensus on best practices for measuring these constructs, which can manifest in myriad and culturally diverse ways e.g. , 8, in cFinally, there is also a lack of conceptual clarity about what constitutes emotional IPV and economic IPV. For emotional IPV, this is apparent in the multitude of terms for the same or similar phenomena, including psychological violence, or abuse. For clarity and a working definition in this paper, emotional IPV includes verbal abuse and humiliation, and threats of violence or other acts to scare a woman . While eThere is emerging evidence that the view that emotional and economic IPV have less health impact than physical or sexual IPV may be wrong. A review of research on IPV and suicide found two studies showing increased suicidal ideation and suicide attempts following emotional IPV, specifically Bangladeshi women were 2\u20133 times more likely to report suicidal ideation if they had experienced emotional IPV . In a loThere are even fewer studies exploring the health impacts of economic IPV, but those that do show that economic IPV also negatively impacts mental health. In Palestine, a nationally representative cross-sectional study showed women who experienced economic IPV were more likely to report depression and anxiety . The natWhile research on health impacts remains limited, it is clear that both economic and emotional IPV are widespread. A systematic review of emotional IPV in pregnancy in Africa estimated that 24.8% to 49% of pregnant African women experienced emotional IPV . In the There are a number of questions about how best to define and measure emotional and economic IPV, and no clear standard has yet emerged. The three major international surveys that have measured these constructs show slight, but important, variations. The WHO Multi-Country Study on Domestic Violence (WHO MCS), and the UN Multi-Country Study on Men and Violence in Asia and the Pacific (UNMCS) and the current Domestic Violence Module (Jan 2017) of the Demographic Health Survey (DHS) vary in the number of items used, and the focus and wording of questions .Just as there is no consensus on the measurement of emotional and economic IPV, there is likewise no consensus on coding and analysis of responses to questionnaire items; this creates further complexities in understanding the prevalence and unique health impacts of these constructs. Some studies treat emotional and economic IPV as separate constructs, while others treat it as one construct \u201321. FurtIn this paper, we argue that through looking at the health impact of emotional IPV, and economic IPV, juxtaposed with the impact of physical and sexual IPV, we can begin to answer many of the central questions in the measurement of emotional and economic IPV. Building this understanding is important for understanding the relative health impact of different forms of IPV, developing and evaluating IPV prevention interventions, and understanding what is most useful to track for monitoring progress towards the SDG. We seek to answer three central questions. First, do economic and emotional IPV, make important, independent contributions to self-reported depressive symptomology and suicidal ideation? Second, if they are important, what matters in their measurement? Is it the number of types, number of episodes, or the overall severity of the IPV? Finally, are some items more important in driving health impacts than other items?Between September 2015 and September 2016, 680 young adult women were recruited to participate in the Stepping Stones and Creating Futures cluster randomized control trial in urban informal settlements surrounding Durban, South Africa. 34 clusters were identified and community leaders approached for inclusion. In each cluster between 19 and 21 women were enrolled into the trial . These aParticipants were aged between 18 and 30 and out of school. Further eligibility criteria included residence in the informal settlement and ability to understand the informed consent process. Participants were not blinded to study arm, those enrolling in the intervention arm received R100 (~US$7) and those in the control arm received R300 (~US$21) for completion of questionnaires. The structured questionnaires were self-completed on cellphones, with built in logic checks and skip patterns. Questionnaires were available in Zulu, Xhosa and English. Research staff matched to the participants by age and gender were available to clarify meaning or assist if literacy or technology posed an issue.Participants provided informed written consent to participate. Ethical approval for the study was received from the University of KwaZulu-Natal, and the South African Medical Research Council. Further details on ethical procedures and research methods are described elsewhere .The content of the questionnaires was almost entirely based on surveys previously used and validated for use in South Africa. Our two key outcomes for this analysis were past week depressive symptomology and past month suicidal ideation.We assessed depressive symptoms using the 20-item The Centre for Epidemiologic Studies Depression Scale (CES-D) scale , which hTo measure past 4 week suicidal ideation, we asked a single item asked whether \u201cthe thought of ending your life been in your mind?\u201d This approach has been used widely to assess suicidal ideation . A binarWe assessed women\u2019s experiences of four types of IPV in the past year: physical, sexual, emotional and economic. Questions on physical IPV were taken from the widely used South African adaption of WHO\u2019s MCS survey . Past yeEmotional IPV in the past year was assessed using the five items from the WHO MCS survey  and adapEconomic IPV was assessed using the four items from the UNMCS survey for women , which wData were uploaded and compiled into a dataset for analysis in Stata IC 14.1. Because of self-completion on cellphones, and inbuilt logic checks, there was very little (<1%) data missing in the sample and no corrections were undertaken for this. Descriptive analyses took into account the clustered nature of the sample, and the 95% confidence intervals (CIs) were calculated using Taylor linearization. Taylor linearization corrects standard errors for the clustered nature of the sample, and provides wider CIs . For eacTo describe associations between the emotional and economic IPV and our chosen mental health outcomes, we first described the prevalence of individual items of emotional IPV and economic IPV. For each item of the emotional and economic IPV scales we report the prevalence of, i) never/ever in the past 12 months, ii) two or more times in the past 12 months versus none or 1, and iii) the frequency of experience . We also report the prevalence of none versus any emotional or economic IPV and two or more versus none or one report of emotional or economic IPV. For each type of IPV described we present the mean and 95% CI for depression scores and the percentage and 95% CI for suicidal ideation.To assess the associations between the four types of IPV exposures and depression/suicidal ideation, we first created a series of four-level categorical variable for a variety of combinations of emotional, economic, sexual and physical IPV and present variation in mental health outcome. For instance, we created a four-level variable for no exposure to violence, one or more emotional IPV exposures only, any emotional IPV and any physical IPV exposure, and physical IPV exposure only. This enabled the creation of \u2018clean\u2019 reference categories for each type of exposure, where typically there is overlap between types of violence that is not accounted for in analyses. We developed different permutations of this violence variable with physical IPV, sexual IPV, economic IPV, combined economic and emotional IPV and then examined if the effects were different if we considered never/ever exposures and higher versus lower frequency of exposure (two or more exposures). For each violence variable we present its frequency and the mean/% and 95% CI for depression symptomatology and suicidal ideation.A total of 680 women were interviewed . Women wAll forms of IPV measured were highly prevalent . Almost Two-thirds (66.5%) of the women reported two or more instances of emotional IPV in in the past year, while just under half (43.7%) reported two or more experiences of economic IPV in the past year. Three-quarters (76.3%) reported two or more experiences of emotional and/or economic IPV in the past year.The mean CES-D score of women in the sample was 21.2. Almost half the sample (45.3%) reported potentially clinically relevant depression (a score of \u2265 21 ), while Tables The most frequently reported form of economic IPV was \u201cyour partner spent money on alcohol, tobacco or other things for himself when he knew you did not have enough for essential household expenses\u201d (38.4%) and the least frequent was taking a woman\u2019s earnings against her will (9.9%) . ApproxiAll measures of emotional and economic IPV we examined showed a consistent positive association with mean CESD-D scores Tables  and 3. FA similar pattern was observed for economic IPV, whereby for all individual items any vs none, and two or more vs none or one comparisons were significantly different with no overlaps of 95% CI. In addition, women reporting many experiences of any individual item had significantly higher depressive symptoms compared to none, while the few category was marginal or non-significant.All measures examined for each of emotional IPV, and economic IPV \u2018full constructrs\u2019  were significantly associated with increased CES-D scores.The overall pattern of associations between emotional IPV, economic IPV, and self-reported suicidal ideation in the last four weeks were similar to those for CES-D scores, but differences were less often significant Tables  and 3. TInteresting differences emerge in looking at the emotional IPV or economic IPV only categories vs the physical and/or sexual IPV only categories. For 15 out of the 18 categorical variables tested, the category of emotional IPV or economic IPV only was associated with higher mean CES-D scores than the category of physical and/or sexual IPV only, the only exception being cases B4-6, looking at multiple events of economic IPV vs multiple events of physical and/or sexual IPV. Cases B4 and B5 also represent the only combinations where physical or sexual violence was significantly different from the no IPV referent, but the variable definition for these cases meant the women who had experience emotional IPV (but not economic) were coded in this group, and so these cases ultimately affirm the importance of emotional IPV as a correlate of CES-D score.This is further affirmed by looking at cases C4-6, which show that the combined category for emotional and/or economic IPV only, associated with significantly higher mean CES-D scores than the categories for physical and/or sexual violence only. Further evidence for the importance of emotional IPV in mean CES-D score is found in case A5, where emotional IPV alone is associated with significantly higher CES-D scores than no IPV .Our analysis clearly highlights the importance of emotional IPV and economic IPV in driving significant mental health impacts for women, and that these extend beyond those found with the current, narrower focus on physical and/or sexual IPV alone. While there is a small, but growing body of research on the health impacts of emotional IPV, and its differential impacts compared to physical and/or sexual IPV , 12, 26,The analysis supports the hypothesis that emotional IPV and economic IPV, have distinct health impacts in themselves. For both economic IPV and emotional IPV the frequency of exposure Tables  and 3 inThere were also differences between the mental health impacts of emotional IPV and economic IPV, despite them being strongly inter-related concepts, they did function as distinctive constructs and should be considered as such. While both emotional IPV and economic IPV had similar patterns around associations with depressive symptomology, there were stronger and more consistent associations between economic IPV and suicidal ideation Tables \u20135, compaThis analysis suggests that emotional IPV and economic IPV should not be regarded as \u2018lighter\u2019 less \u2018important\u2019 forms of IPV when compared to physical and/or sexual IPV, in terms of mental health outcomes. Women in this study who experienced only emotional, or economic IPV reported more depressive symptoms and were more likely to report suicidal ideation than those who experienced physical or sexual IPV only. Major depressive disorders (MDD) for women are common globally, with an estimate past year prevalence of 5.5%, and are associated with increasing death related to physical injuries, self-harm and suicide . MoreoveFinally, the analysis showed that the highest levels of depressive symptoms and prevalence of suicidal ideation, were seen amongst women who experienced emotional IPV or economic IPV, combined with physical IPV or sexual IPV Tables  and 5, sThere are several important implications of the analysis presented here for policy, and for research and evaluation. First, we do not need to measure all forms of emotional IPV and economic IPV to see a mental health impact. The addition of multiple items to questionnaires has often been considered as overly burdensome for studies, and not capturing any distinct impact on women\u2019s health, beyond what has already been captured through assessing physical and sexual IPV. Given the very high prevalence of any emotional IPV and economic IPV and overlaps of types, the returns on measuring additional forms will not yield high returns when viewed in terms of having many more women being \u2018exposed\u2019. As has been shown, emotional IPV and economic IPV have distinct mental health impacts over and above physical and sexual IPV. As such their inclusion is important, but the analysis shows that a relatively small set of items can lead to capturing of these health impacts, particularly when combined with other forms of IPV.Second, we do not need large numbers of indicators in scales to capture health impacts. As shown, measures of ever/never exposures, and in particularly two or more exposures (compared to none or one) capture the majority of mental health impact for women for emotional IPV or economic IPV. As such, it should be possible to derive a smaller sub-set of items that capture the majority of burden that women experience in terms of emotional and economic IPV.Finally, given that emotional IPV and economic IPV have distinctive outcomes in terms of mental health, as well as being clear indicators of severity of impact, when combined with physical and sexual IPV, it is critical that these are included as trial outcomes in interventions seeking to prevent IPV. At a practical level reducing all forms of IPV that have an impact on mental health is crucial, and therefore as emotional IPV and economic IPV have a distinct and separate impact to physical and/or sexual IPV, the impact of interventions on these should be assessed. In addition, other studies have hinted that interventions may have different impacts on different forms of IPV. For instance, an evaluation of Oportunidades in Mexico showed a reduction in physical IPV amongst female recipients, but increases in emotional IPV and increases in threats of violence, however these were not statistically significant .This paper has a number of limitations. First, data is cross-sectional and as such temporality of relationships cannot be ascertained, and there is evidence that the relationship between IPV and depression is bidirectional , 37. SecThe role of emotional IPV and economic IPV in driving health impacts of women is rarely considered, although there is growing interest in emotional IPV, specifically around its consideration as an SDG indicator. The paper clearly highlights that the different forms of IPV  while strongly overlapping also have distinctive health outcomes that need to be considered in research, intervention and policy as such. It is very important that this research is replicated in other datasets and a view on the main findings across multiple settings is reached as this can substantially advance knowledge and understanding of this important area of women\u2019s experience of IPV.S1 Table(DOCX)Click here for additional data file.S1 File(CSV)Click here for additional data file."]}
{"representative": "The growth in Intimate Partner Violence (IPV) cases among couples in Nigeria has been significant in recent years. Victims, which are often females, face numerous health challenges, including early death. I examined the linkages between spousal age differences and IPV in Nigeria.n\u2009=\u20096765). Intimate partner violence was measured using 13-item questions. Data were analyzed using the logistic regression model (\u03b1\u2009=\u2009.05).The couples recode data section of the 2013 Nigeria Demographic Health and Survey was used  and 1.35  higher in households where the spousal age difference was 0\u20134 and 5\u20139\u00a0years respectively, than the likelihoods among those with a spousal age difference\u2009\u2265\u200915\u00a0years, but the strength of the association weakens when other variables were included in the model.The mean spousal age difference was 8.20\u2009\u00b1\u20095.0\u00a0years. About 23.5, 18.0, 13.5 and 4.7% of couples surveyed had experienced some form of IPV, emotional, physical and sexual violence respectively. Also, IPV prevalence was 27.0, 23.7, 22.0 and 18.7% among couples with age differences of 0\u20134, 5\u20139, 10\u201314 and \u226515\u00a0years respectively; this pattern was exhibited across all domains of IPV. Among women who experienced physical violence, 20.5% had only bruises, 8.0% had at least one case of eye injuries, sprains and/or dislocations, and 3.7% had either one or more cases of wounds, broken bones or broken teeth. The identified predictors of IPV were: family size, ethnicity, household wealth, education, number of marital unions and husband drinks alcohol. The unadjusted likelihood of IPV was 1.60 (C.The level of IPV was generally high in Nigeria, but it reduced with increasing spousal age difference. This study underscores the need for men to reach a certain level of maturity before marriage, as this is likely to reduce the level of IPV in Nigeria. Violence against women is \u201cany act of gender-based violence that results in, or is likely to result in, physical, sexual or psychological harm or suffering to women, including threats of such acts, coercion or arbitrary deprivation of liberty, whether occurring in public or in private life\u201d . IntimatLiterature on IPV in low-income countries has focused largely on Asia \u20136 and soSpousal healthy relations and a successful married life are the result of many factors. One salient factor, which usually goes unnoticed is spousal age difference. Spousal age difference refers to the difference between the ages of wife and husband. The tradition of male dominance in marriage is still prevalent in Nigeria, where, apart from a few exceptions, men marry women that are younger than they are . This coWomen bear the overwhelming burden of IPV in Nigeria. The 1993 United Nations General Assembly resolution recommends the promotion of research, especially regarding domestic violence, relating to the prevalence of different forms of violence against women, and encourages research on the consequences of violence against women [A growing number of research has been conducted into the factors associated with IPV and its three domains , 12, 13.In sub-Saharan Africa, the IPV prevalence ranges from 30.5% in Nigeria to 43.4% in Zimbabwe, 45.3% in Kenya, 45.5% in Mozambique, 53.9% in Zambia and 57.6% in Cameroun . A studyIn order to understand IPV within a family violence structure, different frameworks have been used by sociologists. The family violence perspective views conflict between family members as universal and inevitable, and holds the view that most family violence is not the result of individual pathology but that it is a \u201cnormal part of family life in most societies\u201d . Straus A nested ecological theory by Dutton and Nicholls states that more precise variables are viewed as \u2018nested in\u2019 broader variables . This thThis study was conducted in Nigeria, a country in the West African sub-region. By geographic definition, Nigeria is predominantly a rural country and the level of illiteracy is high. A national survey found that the median age at first marriage for men and women was 18.1 and 27.2\u00a0years respectively .The study was cross-sectional population-based and used weighted 2013 Nigeria Demographic and Health Survey data, with a focus on the couple recode section of the data. It was a nationally representative sample, with participants selected across all the states in Nigeria. The survey used as a sampling frame the list of enumeration areas (EAs). Administratively, Nigeria is divided into 36 states and a Federal Capital Territory (FCT). These states are subdivided into 774 LGAs, and each LGA is divided into localities. Each locality was subdivided into EAs. The EAs, which were the primary sampling units (PSU), were used as a cluster with a minimum size of 80 households. The sample was selected using a stratified three-stage cluster design, consisting of 904 clusters, 372 in urban areas and 532 in rural areas. A complete listing of households and a mapping exercise were carried out in each cluster, with the resulting lists of households serving as the sampling frame for the selection of households. All regular households were listed. Global Positioning System (GPS) receivers were used to calculate the coordinates of the sample clusters. A fixed sample of 45 households was selected per cluster. In this study, a sample of one eligible woman in each household was randomly selected to be asked questions regarding domestic violence .Only couples with complete information on variables that were used for the generation of IPV and age difference were included in the study. A small number of cases, where women were older than their husbands, were excluded. Thus, the total sample of couples included in the study was 6765. Intimate partner violence was created using information on the following items:The items 1\u20133, 4\u201310 and 11\u201313 above constitute the emotional violence (EV), physical violence (PV) and sexual violence (SV) domains respectively, as measured by the demographic health and survey . In ordeThe main independent variable was spousal age difference, which was generated by subtracting the ages of the women from the ages of their husbands. These age gaps were later categorized as 0\u20134, 5\u20139, 10\u201314 and \u226515\u00a0years with a view to examining which spousal age gap inhibits or promotes IPV, other than using age difference as a continuous variable in the analysis. Other independent variables include the following: number of living children, residence, ethnicity, religion, household wealth, education, marriage type, husband drinking alcohol, husband\u2019s education, number of marital unions and empowerment.p-value cut-off point of 0.25 was included in the first model. In the iterative process of variable selection, covariates were removed from the model if they were not significant  and not a confounder. At the end of the iterative process of deleting, refitting, and verifying, the final model was fitted.Data were analyzed using t-test, Chi-square and logistic regression at 5% level of significance. The t-test was used to determine the mean age difference by IPV. The Chi-square was used to examine the association between IPV, EV, PV, SV and socio-demographic characteristics, including spousal age difference. Due to the dichotomous nature of each of the dependent variable, we used the logistic regression model to identify the predictors of IPV and other domains of violence. The selection of variables into the logistic regression was done by running a bivariate analysis of the dependent variable and an independent variable. Thereafter, any statistically significant variable based on the Wald test from logistic regression and a Two models (unadjusted and adjusted) were used to examine the relationship between age difference and IPV, EV, PV, SV. The unadjusted models Eq.  were the0, \u03b2pi are the regression parameters, xi are the independent variables, and pi represents the proportion of women who have experienced IPV in the ith category of a particular variable.\u03b2In Table\u00a0p\u2009<\u20090.001) and 27.0%-to-18.7% (p\u2009<\u20090.001) respectively. In the case of sexual violence, the pattern was different from the patterns exhibited by IPV, physical, and emotional violence. The percentage of women who had experienced sexual violence was 4.6%, 4.9%, 4.7% and 4.2% among couples with the age differences of 0\u20134, 5\u20139, 10\u201314 and 15+ years respectively (p\u2009>\u20090.05).Figure\u00a0The data as shown in Fig.\u00a0p\u2009<\u20090.001).The data presented in Table\u00a0Ethnicity and religion were significantly associated with all the domains of violence. In the main religious groups in Nigeria, the data show that Igbo women experienced more IPV (28.0%), emotional (24.0%) and sexual violence (4.3%) than did women in the Yoruba and Igbo ethnic groups, but Yoruba women (17.2%) experienced the physical violence among the three ethnic groups. A higher proportion of Christian women than Muslim women experienced IPV (33.8% vs 15.8%), emotional (25.4% vs 12.4%), physical (22.6% vs 6.6%) and sexual violence (5.7% vs 4.0%). The data further show that emotional violence was the only violence domain that was not associated with household wealth. A slight disparity existed between the percentage of women who experienced any type of IPV, physical or sexual violence among those who come from middle-income and rich households, but the margin was wider between middle-class and poor households. The percentage of women who experienced IPV forms a U-shape, with women with no formal education and those with higher education having previously experienced lower levels of violence from their intimate partner than did women who had primary and secondary education. For instance, the prevalence of IPV was 16.0%, 32.5%, 29.6% and 19.0% among those with no formal, primary, secondary and higher education respectively. This was also the pattern exhibited based on the husband\u2019s level of education. Surprisingly, IPV was found to be higher among highly empowered women than those in low level of empowerment.The percentage of women who reported that they had experienced violence from their intimate partner was strikingly higher among spouses of men who drink alcohol. With regard to previous experiences of any type of IPV, the percentage of women was 45.4% among women whose husbands drank alcohol, compared to 18.5% among women whose husbands did not drink alcohol. In the case of emotional violence, it was 35.1% and 14.1% among women whose husbands drank alcohol and whose husbands were non-drinkers respectively. In the case of physical violence, 33.2% of women whose husbands drank alcohol had experienced such violence, compared to 9.1% of women whose husbands did not drink alcohol.I\u2009=\u20091.30\u20131.98, p\u2009<\u20090.001), 1.35  and 1.23  higher in households where the spousal age differences were 0\u20134, 5\u20139 and 10\u201314 respectively, than among those with a spousal age difference of at least 15\u00a0years. In particular, being in spousal age difference groups 0\u20134 , 5\u20139 , and 10\u201314  years seemed to predispose women to physical violence than among couples where the age difference was 15\u00a0years and above. Spousal age difference was not found to be significantly related to sexual violence.The data as presented in Table\u00a0I\u2009=\u20091.65\u20132.63, p\u2009<\u20090.001), 2.87  and 2.46  times more likely among couples who had given birth to 1\u20132, 3\u20134 and \u22655 children respectively than among couples who have no children; this pattern was similar to the emotional and physical violence experienced. Among all the types of violence, only the sexual domain shows a significant relationship with place of residence. In this case, the likelihood of sexual violence was found to be higher in the rural areas  than in the urban areas. In terms of the relationship between ethnicity and IPV, the odds of IPV, emotional violence and physical violence were lowest among Hausa/Fulani women and highest among Igbo women. However, Yoruba women experienced lower sexual violence  than Hausa/Fulani women. In addition, women who practiced the Islamic religion were less likely to experience IPV or any of IPV domains than their Christianity counterparts were. The data further show that the risk of any violence type was significantly higher in households where the husbands drank alcohol. Moreover, the likelihood of IPV, emotional violence and physical violence was 1.48 , 1.39  and 1.50  higher among women with a high empowerment status than among women with a low empowerment status, although there was no significant relationship between empowerment status and sexual violence.The risk of IPV was higher among couples who have at least one child than among those without any children. In particular, the odds ratio of IPV was 2.09 , 2.37  and 2.15  higher among couples who had 1\u20132, 3\u20134 and 5+ living children respectively, than among those who had never had any children. This statistically significant pattern was also exhibited by physical, emotional violence and number of living children. The Igbo and Yoruba women were more likely to have experienced IPV, emotional and physical violence than were Hausa/Fulani women. The odds of experiencing IPV was 1.80  and 1.93  higher among Igbo and Yoruba women respectively than among their Hausa/Fulani counterparts. With regard to previous experiences of physical violence, Yoruba women had a higher risk  than did Hausa/Fulani women. Also the chance of sexual violence was higher among Igbo women  than among Hausa/Fulani women. Having been married more than once  furthermore predisposes Nigerian women to a higher risk of sexual violence than was the case among those who had only been married once.The likelihood of IPV was 1.78c  times higher among women whose husbands drank alcohol; this pattern was found across the three domains of violence. The likelihood of IPV, physical violence and sexual violence falls consistently with increasing level of household wealth. While the data showed no significant difference between women with no formal education and those who had a higher level of education with regard to the violence they had experienced, whether IPV, sexual or emotional violence, the risks were significantly higher among women with a primary and secondary level of education than among those with no formal education. The likelihood of IPV was 1.57  and 1.55  higher among women with primary and secondary education respectively than among those with no formal education. For sexual violence, the chance was 1.60  and 1.70  higher among women with primary and secondary education than among those with no formal education.The likelihood of IPV was 2.25 (C.Intimate partner violence is a problem that potentially affects every family, although its severity level varies across socio-cultural characteristics , 12. In The study revealed that the average spousal age difference was 8.20\u2009\u00b1\u20095.0\u00a0years, and the mean difference was lower among households where wives have experienced some form of IPV. This implies that men who commit IPV are much older than their wives. Traditionally, men marry women who are younger than they are; the persistent harsh economic conditions that have lasted for about four decades in Nigeria have led to men only marrying later in life, which further widens the age gap between couples. The expectation is that IPV should reduce where the spousal age difference is wider, because in such instances, the man is expected to be more mature than his wife, and thus should be able to tolerate some inadequacies of his wife in terms of behavioral attitudes. However, it seems that this expectation is not correct, as reviewed in the theoretical framework in the background section of this paper. Although the odds of IPV significantly reduced as spousal age difference increases, spousal age difference was not found to be a predictor of IPV. This finding is consistent with the outcome of the study conducted in America .In this study, about one in every four women had experienced IPV, while emotional violence was found to be the most prevalent of the domains of IPV, followed by physical and sexual violence in that order. This variation pattern in the prevalence of IPV and its domains echoes the findings of studies previously conducted in Nigeria and some parts of Africa , 11, 14.The number of years that couples had been married appeared to be important to IPV . The shaThe chance that a woman would experience violence from her intimate partner was found to increase, as the family size increased; it was lowest among couples who did not have children. The prolonged harsh economic conditions in Nigeria, combined with the high levels of unemployment, which has caused the failure of some men to discharge their responsibilities as head of the household could be responsible for this finding. All things being equal, under the current economic condition in Nigeria, it is assumed that families with a lower number of children may find it easier to meet their immediate needs than families with a larger number of children. Where resources are lacking and when facing numerous family needs that are echoed by the wife, the husband may resort to violence . This isThe cultural environment is important when discussing issues relating to IPV . In marrEducation is a way of breaking the prevalence of male dominance in marriage, irrespective of the spousal age difference. It is known that women who are more educated are also more likely to be aware of their fundamental human rights and thus more empowered within the household in terms of their involvement in family issues/decisions than women who have received less education. The tussle for power and the non-compliance or disagreement of women with some of the rules laid down by the husband may trigger violence within the marriage. As one of the important predictors of IPV in this study, the positive relationship between level of education and IPV, where increasing the level of education was found to be non-protective of IPV, has been established in the literature  but the This study had some limitations. Firstly, it is likely that IPV cases are under-reported, because women are often afraid or reluctant to report it, particularly among low-income groups. It is also likely that some communities may have reservations about reporting IPV in general. These certainly will have an implication on the prevalence of IPV found in this study. Therefore, our results may not be representative of all cases of IPV and may be biased towards populations with more sensitization towards IPV or a greater awareness of programmes relating to IPV. According to the findings of this study, however, more efforts are needed to reduce the level of IPV, as stipulated by the SDGs. Secondly, it is also likely that the number of IPV cases was grossly under-reported because women who were hospitalized as a result of experiencing violence during the course of the survey, were not captured due to the population-based nature of this study. Thirdly, the cross-sectional nature of this study suggests that causality cannot be clearly established, and therefore the readers of this article should interpret the findings with caution. Lastly, family arrangement has a direct relation to IPV, but that has not been covered because the data did not capture information that could be used for such analysis.The level of IPV found in this study was high; it appeared to reduce with increasing spousal age difference. Spousal age difference is not a predictor of IPV, but a higher spousal age difference was found to be protective of IPV. Therefore, this study recommends that men need to be sufficiently mature before entering into marriage, as this will reduce the level of IPV in Nigeria. Strategies to eradicate IPV in Nigeria should target couples with lower age differences as well as families where the husband drinks alcohol. While the age difference may not really be an important factor in examining IPV amidst other covariates, the predictors of IPV found in this study were: family size, ethnicity, household wealth, education, marital duration and husband\u2019s alcohol consumption. These factors should be taken into consideration when designing frameworks on reducing IPV in Nigeria. The findings underscore the risk associated with the influence of spousal age difference on IPV. Context-specific qualitative studies are needed in Nigeria to explore the relationship between partner age differences and IPV further.", "texts": ["The growth in Intimate Partner Violence (IPV) cases among couples in Nigeria has been significant in recent years. Victims, which are often females, face numerous health challenges, including early death. I examined the linkages between spousal age differences and IPV in Nigeria.n\u2009=\u20096765). Intimate partner violence was measured using 13-item questions. Data were analyzed using the logistic regression model (\u03b1\u2009=\u2009.05).The couples recode data section of the 2013 Nigeria Demographic Health and Survey was used  and 1.35  higher in households where the spousal age difference was 0\u20134 and 5\u20139\u00a0years respectively, than the likelihoods among those with a spousal age difference\u2009\u2265\u200915\u00a0years, but the strength of the association weakens when other variables were included in the model.The mean spousal age difference was 8.20\u2009\u00b1\u20095.0\u00a0years. About 23.5, 18.0, 13.5 and 4.7% of couples surveyed had experienced some form of IPV, emotional, physical and sexual violence respectively. Also, IPV prevalence was 27.0, 23.7, 22.0 and 18.7% among couples with age differences of 0\u20134, 5\u20139, 10\u201314 and \u226515\u00a0years respectively; this pattern was exhibited across all domains of IPV. Among women who experienced physical violence, 20.5% had only bruises, 8.0% had at least one case of eye injuries, sprains and/or dislocations, and 3.7% had either one or more cases of wounds, broken bones or broken teeth. The identified predictors of IPV were: family size, ethnicity, household wealth, education, number of marital unions and husband drinks alcohol. The unadjusted likelihood of IPV was 1.60 (C.The level of IPV was generally high in Nigeria, but it reduced with increasing spousal age difference. This study underscores the need for men to reach a certain level of maturity before marriage, as this is likely to reduce the level of IPV in Nigeria. Violence against women is \u201cany act of gender-based violence that results in, or is likely to result in, physical, sexual or psychological harm or suffering to women, including threats of such acts, coercion or arbitrary deprivation of liberty, whether occurring in public or in private life\u201d . IntimatLiterature on IPV in low-income countries has focused largely on Asia \u20136 and soSpousal healthy relations and a successful married life are the result of many factors. One salient factor, which usually goes unnoticed is spousal age difference. Spousal age difference refers to the difference between the ages of wife and husband. The tradition of male dominance in marriage is still prevalent in Nigeria, where, apart from a few exceptions, men marry women that are younger than they are . This coWomen bear the overwhelming burden of IPV in Nigeria. The 1993 United Nations General Assembly resolution recommends the promotion of research, especially regarding domestic violence, relating to the prevalence of different forms of violence against women, and encourages research on the consequences of violence against women [A growing number of research has been conducted into the factors associated with IPV and its three domains , 12, 13.In sub-Saharan Africa, the IPV prevalence ranges from 30.5% in Nigeria to 43.4% in Zimbabwe, 45.3% in Kenya, 45.5% in Mozambique, 53.9% in Zambia and 57.6% in Cameroun . A studyIn order to understand IPV within a family violence structure, different frameworks have been used by sociologists. The family violence perspective views conflict between family members as universal and inevitable, and holds the view that most family violence is not the result of individual pathology but that it is a \u201cnormal part of family life in most societies\u201d . Straus A nested ecological theory by Dutton and Nicholls states that more precise variables are viewed as \u2018nested in\u2019 broader variables . This thThis study was conducted in Nigeria, a country in the West African sub-region. By geographic definition, Nigeria is predominantly a rural country and the level of illiteracy is high. A national survey found that the median age at first marriage for men and women was 18.1 and 27.2\u00a0years respectively .The study was cross-sectional population-based and used weighted 2013 Nigeria Demographic and Health Survey data, with a focus on the couple recode section of the data. It was a nationally representative sample, with participants selected across all the states in Nigeria. The survey used as a sampling frame the list of enumeration areas (EAs). Administratively, Nigeria is divided into 36 states and a Federal Capital Territory (FCT). These states are subdivided into 774 LGAs, and each LGA is divided into localities. Each locality was subdivided into EAs. The EAs, which were the primary sampling units (PSU), were used as a cluster with a minimum size of 80 households. The sample was selected using a stratified three-stage cluster design, consisting of 904 clusters, 372 in urban areas and 532 in rural areas. A complete listing of households and a mapping exercise were carried out in each cluster, with the resulting lists of households serving as the sampling frame for the selection of households. All regular households were listed. Global Positioning System (GPS) receivers were used to calculate the coordinates of the sample clusters. A fixed sample of 45 households was selected per cluster. In this study, a sample of one eligible woman in each household was randomly selected to be asked questions regarding domestic violence .Only couples with complete information on variables that were used for the generation of IPV and age difference were included in the study. A small number of cases, where women were older than their husbands, were excluded. Thus, the total sample of couples included in the study was 6765. Intimate partner violence was created using information on the following items:The items 1\u20133, 4\u201310 and 11\u201313 above constitute the emotional violence (EV), physical violence (PV) and sexual violence (SV) domains respectively, as measured by the demographic health and survey . In ordeThe main independent variable was spousal age difference, which was generated by subtracting the ages of the women from the ages of their husbands. These age gaps were later categorized as 0\u20134, 5\u20139, 10\u201314 and \u226515\u00a0years with a view to examining which spousal age gap inhibits or promotes IPV, other than using age difference as a continuous variable in the analysis. Other independent variables include the following: number of living children, residence, ethnicity, religion, household wealth, education, marriage type, husband drinking alcohol, husband\u2019s education, number of marital unions and empowerment.p-value cut-off point of 0.25 was included in the first model. In the iterative process of variable selection, covariates were removed from the model if they were not significant  and not a confounder. At the end of the iterative process of deleting, refitting, and verifying, the final model was fitted.Data were analyzed using t-test, Chi-square and logistic regression at 5% level of significance. The t-test was used to determine the mean age difference by IPV. The Chi-square was used to examine the association between IPV, EV, PV, SV and socio-demographic characteristics, including spousal age difference. Due to the dichotomous nature of each of the dependent variable, we used the logistic regression model to identify the predictors of IPV and other domains of violence. The selection of variables into the logistic regression was done by running a bivariate analysis of the dependent variable and an independent variable. Thereafter, any statistically significant variable based on the Wald test from logistic regression and a Two models (unadjusted and adjusted) were used to examine the relationship between age difference and IPV, EV, PV, SV. The unadjusted models Eq.  were the0, \u03b2pi are the regression parameters, xi are the independent variables, and pi represents the proportion of women who have experienced IPV in the ith category of a particular variable.\u03b2In Table\u00a0p\u2009<\u20090.001) and 27.0%-to-18.7% (p\u2009<\u20090.001) respectively. In the case of sexual violence, the pattern was different from the patterns exhibited by IPV, physical, and emotional violence. The percentage of women who had experienced sexual violence was 4.6%, 4.9%, 4.7% and 4.2% among couples with the age differences of 0\u20134, 5\u20139, 10\u201314 and 15+ years respectively (p\u2009>\u20090.05).Figure\u00a0The data as shown in Fig.\u00a0p\u2009<\u20090.001).The data presented in Table\u00a0Ethnicity and religion were significantly associated with all the domains of violence. In the main religious groups in Nigeria, the data show that Igbo women experienced more IPV (28.0%), emotional (24.0%) and sexual violence (4.3%) than did women in the Yoruba and Igbo ethnic groups, but Yoruba women (17.2%) experienced the physical violence among the three ethnic groups. A higher proportion of Christian women than Muslim women experienced IPV (33.8% vs 15.8%), emotional (25.4% vs 12.4%), physical (22.6% vs 6.6%) and sexual violence (5.7% vs 4.0%). The data further show that emotional violence was the only violence domain that was not associated with household wealth. A slight disparity existed between the percentage of women who experienced any type of IPV, physical or sexual violence among those who come from middle-income and rich households, but the margin was wider between middle-class and poor households. The percentage of women who experienced IPV forms a U-shape, with women with no formal education and those with higher education having previously experienced lower levels of violence from their intimate partner than did women who had primary and secondary education. For instance, the prevalence of IPV was 16.0%, 32.5%, 29.6% and 19.0% among those with no formal, primary, secondary and higher education respectively. This was also the pattern exhibited based on the husband\u2019s level of education. Surprisingly, IPV was found to be higher among highly empowered women than those in low level of empowerment.The percentage of women who reported that they had experienced violence from their intimate partner was strikingly higher among spouses of men who drink alcohol. With regard to previous experiences of any type of IPV, the percentage of women was 45.4% among women whose husbands drank alcohol, compared to 18.5% among women whose husbands did not drink alcohol. In the case of emotional violence, it was 35.1% and 14.1% among women whose husbands drank alcohol and whose husbands were non-drinkers respectively. In the case of physical violence, 33.2% of women whose husbands drank alcohol had experienced such violence, compared to 9.1% of women whose husbands did not drink alcohol.I\u2009=\u20091.30\u20131.98, p\u2009<\u20090.001), 1.35  and 1.23  higher in households where the spousal age differences were 0\u20134, 5\u20139 and 10\u201314 respectively, than among those with a spousal age difference of at least 15\u00a0years. In particular, being in spousal age difference groups 0\u20134 , 5\u20139 , and 10\u201314  years seemed to predispose women to physical violence than among couples where the age difference was 15\u00a0years and above. Spousal age difference was not found to be significantly related to sexual violence.The data as presented in Table\u00a0I\u2009=\u20091.65\u20132.63, p\u2009<\u20090.001), 2.87  and 2.46  times more likely among couples who had given birth to 1\u20132, 3\u20134 and \u22655 children respectively than among couples who have no children; this pattern was similar to the emotional and physical violence experienced. Among all the types of violence, only the sexual domain shows a significant relationship with place of residence. In this case, the likelihood of sexual violence was found to be higher in the rural areas  than in the urban areas. In terms of the relationship between ethnicity and IPV, the odds of IPV, emotional violence and physical violence were lowest among Hausa/Fulani women and highest among Igbo women. However, Yoruba women experienced lower sexual violence  than Hausa/Fulani women. In addition, women who practiced the Islamic religion were less likely to experience IPV or any of IPV domains than their Christianity counterparts were. The data further show that the risk of any violence type was significantly higher in households where the husbands drank alcohol. Moreover, the likelihood of IPV, emotional violence and physical violence was 1.48 , 1.39  and 1.50  higher among women with a high empowerment status than among women with a low empowerment status, although there was no significant relationship between empowerment status and sexual violence.The risk of IPV was higher among couples who have at least one child than among those without any children. In particular, the odds ratio of IPV was 2.09 , 2.37  and 2.15  higher among couples who had 1\u20132, 3\u20134 and 5+ living children respectively, than among those who had never had any children. This statistically significant pattern was also exhibited by physical, emotional violence and number of living children. The Igbo and Yoruba women were more likely to have experienced IPV, emotional and physical violence than were Hausa/Fulani women. The odds of experiencing IPV was 1.80  and 1.93  higher among Igbo and Yoruba women respectively than among their Hausa/Fulani counterparts. With regard to previous experiences of physical violence, Yoruba women had a higher risk  than did Hausa/Fulani women. Also the chance of sexual violence was higher among Igbo women  than among Hausa/Fulani women. Having been married more than once  furthermore predisposes Nigerian women to a higher risk of sexual violence than was the case among those who had only been married once.The likelihood of IPV was 1.78c  times higher among women whose husbands drank alcohol; this pattern was found across the three domains of violence. The likelihood of IPV, physical violence and sexual violence falls consistently with increasing level of household wealth. While the data showed no significant difference between women with no formal education and those who had a higher level of education with regard to the violence they had experienced, whether IPV, sexual or emotional violence, the risks were significantly higher among women with a primary and secondary level of education than among those with no formal education. The likelihood of IPV was 1.57  and 1.55  higher among women with primary and secondary education respectively than among those with no formal education. For sexual violence, the chance was 1.60  and 1.70  higher among women with primary and secondary education than among those with no formal education.The likelihood of IPV was 2.25 (C.Intimate partner violence is a problem that potentially affects every family, although its severity level varies across socio-cultural characteristics , 12. In The study revealed that the average spousal age difference was 8.20\u2009\u00b1\u20095.0\u00a0years, and the mean difference was lower among households where wives have experienced some form of IPV. This implies that men who commit IPV are much older than their wives. Traditionally, men marry women who are younger than they are; the persistent harsh economic conditions that have lasted for about four decades in Nigeria have led to men only marrying later in life, which further widens the age gap between couples. The expectation is that IPV should reduce where the spousal age difference is wider, because in such instances, the man is expected to be more mature than his wife, and thus should be able to tolerate some inadequacies of his wife in terms of behavioral attitudes. However, it seems that this expectation is not correct, as reviewed in the theoretical framework in the background section of this paper. Although the odds of IPV significantly reduced as spousal age difference increases, spousal age difference was not found to be a predictor of IPV. This finding is consistent with the outcome of the study conducted in America .In this study, about one in every four women had experienced IPV, while emotional violence was found to be the most prevalent of the domains of IPV, followed by physical and sexual violence in that order. This variation pattern in the prevalence of IPV and its domains echoes the findings of studies previously conducted in Nigeria and some parts of Africa , 11, 14.The number of years that couples had been married appeared to be important to IPV . The shaThe chance that a woman would experience violence from her intimate partner was found to increase, as the family size increased; it was lowest among couples who did not have children. The prolonged harsh economic conditions in Nigeria, combined with the high levels of unemployment, which has caused the failure of some men to discharge their responsibilities as head of the household could be responsible for this finding. All things being equal, under the current economic condition in Nigeria, it is assumed that families with a lower number of children may find it easier to meet their immediate needs than families with a larger number of children. Where resources are lacking and when facing numerous family needs that are echoed by the wife, the husband may resort to violence . This isThe cultural environment is important when discussing issues relating to IPV . In marrEducation is a way of breaking the prevalence of male dominance in marriage, irrespective of the spousal age difference. It is known that women who are more educated are also more likely to be aware of their fundamental human rights and thus more empowered within the household in terms of their involvement in family issues/decisions than women who have received less education. The tussle for power and the non-compliance or disagreement of women with some of the rules laid down by the husband may trigger violence within the marriage. As one of the important predictors of IPV in this study, the positive relationship between level of education and IPV, where increasing the level of education was found to be non-protective of IPV, has been established in the literature  but the This study had some limitations. Firstly, it is likely that IPV cases are under-reported, because women are often afraid or reluctant to report it, particularly among low-income groups. It is also likely that some communities may have reservations about reporting IPV in general. These certainly will have an implication on the prevalence of IPV found in this study. Therefore, our results may not be representative of all cases of IPV and may be biased towards populations with more sensitization towards IPV or a greater awareness of programmes relating to IPV. According to the findings of this study, however, more efforts are needed to reduce the level of IPV, as stipulated by the SDGs. Secondly, it is also likely that the number of IPV cases was grossly under-reported because women who were hospitalized as a result of experiencing violence during the course of the survey, were not captured due to the population-based nature of this study. Thirdly, the cross-sectional nature of this study suggests that causality cannot be clearly established, and therefore the readers of this article should interpret the findings with caution. Lastly, family arrangement has a direct relation to IPV, but that has not been covered because the data did not capture information that could be used for such analysis.The level of IPV found in this study was high; it appeared to reduce with increasing spousal age difference. Spousal age difference is not a predictor of IPV, but a higher spousal age difference was found to be protective of IPV. Therefore, this study recommends that men need to be sufficiently mature before entering into marriage, as this will reduce the level of IPV in Nigeria. Strategies to eradicate IPV in Nigeria should target couples with lower age differences as well as families where the husband drinks alcohol. While the age difference may not really be an important factor in examining IPV amidst other covariates, the predictors of IPV found in this study were: family size, ethnicity, household wealth, education, marital duration and husband\u2019s alcohol consumption. These factors should be taken into consideration when designing frameworks on reducing IPV in Nigeria. The findings underscore the risk associated with the influence of spousal age difference on IPV. Context-specific qualitative studies are needed in Nigeria to explore the relationship between partner age differences and IPV further."]}
{"representative": "Over the years, researchers have relied on data from women victims to understand the profile on male perpetrators of intimate partner violence (IPV). IPV studies with male participants in the general population are still emerging in Africa. The contribution of mental ill health to IPV perpetration in the general population that has been documented elsewhere is emergent. Notwithstanding, research with male perpetrators is essential to informing effective prevention programmes and interventions. To contribute to the emerging literature on male perpetrators, we conducted a study to estimate the prevalence and factors associated with IPV perpetration by men in heterosexual relationships. We also modelled pathways to IPV perpetration using data from Zimbabwe.Data were collected through a nationwide survey employing a random and multi-staged sampling method. We recruited and administered a structured questionnaire to 2838 men aged 18\u00a0years and above. IPV was measured using an adapted WHO Domestic Violence Questionnaire. Determinants of IPV measured included child abuse, alcohol abuse, post-traumatic stress disorder (PTSD), depressive symptoms, personal gender attitudes and risky sexual behaviours. Multivariate regression modelling was used to assess factors associated with IPV perpetration. Structural equation modelling was used to explore the underlying pathways to recent IPV perpetration.Forty one percent of men had perpetrated IPV in their lifetime and 8.8% percent of men perpetrated IPV in the 12\u00a0months before the survey. Older, more educated men, men who binge drank, men who were abused as children or experienced other life traumatic experiences were more likely to perpetrate IPV in lifetime. Depressive symptoms and sexual relationship power (were also associated with lifetime IPV perpetration. IPV perpetration in the last 12\u00a0months was associated with binge drinking, PTSD and sexual relationship power. The pathways to IPV perpetration in the last 12\u00a0months from child abuse to recent IPV were mediated by comorbid PTSD symptoms, depression binge drinking and sexual relationship power.IPV perpetration was associated with child abuse history, mental ill health, sexual relationship power and personal gender attitudes. Interventions to reduce IPV need to engage men to address gender inequality, mental ill health and reduce alcohol consumption. According to the World Health Organisation, one in every three women (35%) across the globe have experienced some form of physical and or sexual violence perpetrated by their male intimate partner in their lifetime . PopulatUse of violence is more prevalent among men who endorse patriarchal norms supporting male dominance and sexual entitlement is more prevalent among men using violence . Men enaMental ill health, in particular, post-traumatic stress disorder has been shown to increase risk for IPV perpetration , 17. PTSResearch conducted in Zimbabwe with women shows that IPV is a prevalent societal problem \u201324. HoweThe study was a cross sectional national household survey conducted in 2012 in Zimbabwe. In the survey, participants were selected through a multi-stage random sampling method, using the 2002 Zimbabwe Population Census as the primary sampling frame. At the first sampling stage districts were sampled from all the 10 provinces using a proportionate to size method. At the district level, the primary sampling unit used were the Enumeration Areas (EAs). An enumeration area, also called a census block or census tract, is the smallest geographic unit for which census information is aggregated, compiled and disseminated. An enumeration area is defined by boundaries described on a sketch map or in a geographic information system (GIS) database . Again, The study was conducted in collaboration with and approved by the Government of Zimbabwe\u2019s Ministry of Women Affairs, Gender and Community Development (MWAGCD). Participation in the study was voluntary and prior written informed consent was given by all participants. Interviews were conducted in privacy and participants were assured of confidentiality. To ensure anonymity participants were assigned to random study ID numbers. Unlike studies of women\u2019s experiences of violence where risk for IPV after the interview is high and the need for counselling and support is much more pronounced , the plaData was collected through self-administered questionnaires loaded onto a personal digital assistant (PDA). Men aged 18 or older normally resident in the sampled household were recruited and interviewed by trained male researchers using structured questionnaires in a language chosen by the participant from English, Shona or Ndebele.. IPV experience in the past 12\u00a0months was measured using a follow-up question to each set of sub-scale questions for emotional, sexual and physical IPV as follows: \u201cHave any of these things happened in the past 12 months?\u201d The composite lifetime IPV variable was derived from combining the physical and/or sexual IPV and emotional IPV subscale items and if a man had done any of the acts towards a partner. A similar approach was used for the IPV past 12\u00a0months variable.The primary outcome of interest was lifetime sexual or physical IPV perpetration and these were measured using an adapted and pretested version of the WHO Multi-Country Study on Women\u2019s Health and Domestic Violence: Core Questionnaire and WHO Instrument \u2013 Version 9 designed for use in developing countries . Table\u00a01(Table 1). Responses to items were Never . R. R(TableTable ))  or No  to measure attitudes toward gender norms in intimate relationships and differing social expectations for men and women Table  32]. Re. Re32]. We used an adaptation of the Sexual Relationship Power Scale (SRPS) to measure power within sexual relationships. The scale consisted of relationship control items that predict sexual and physical violence, condom use and partner infidelity Table  33]. Re. Re33]. n\u2009=\u2009436). All data analyses were done using Stata version 13 considering the survey\u2019s multi-stage sample design. We used cross tabulations to describe the prevalence of lifetime and past 12\u00a0months IPV perpetration against the different sociodemographic variables, binge drinking, and sexual partners (Table\u00a02). For the continuous variables - Child abuse, CESD, PTSD, Life events, GEM and SRPS Scores, we used t-tests to compare the means across perpetrator vs non-perpetrator groups for both the lifetime IPV and past 12\u00a0months IPV (Table\u00a0).For this secondary analyses we excluded men who had never been in a heterosexual intimate relationship n\u2009=\u200946. All dap-value less than 0.2 in bivariate analyses into regression models. We controlled for the effect of sociodemographic variables  in models. We then used a stepwise backward elimination approach to eliminate non-significant associations until final models were arrived at that were parsimonious (Table\u00a0).To test for factors associated with lifetime and past 12\u00a0months IPV, we built logistic regression models. We included characteristics that had a us Table\u00a0.Table 4FFurther to the logistic regression modelling, we employed Structural Equation Modelling (SEM) with maximum likelihood estimation to investigate the underlying pathways of factors associated with recent/or 12\u00a0months IPV perpetration. Our a priori model was that there were significant inter-relationships between variables. Child abuse could be associated with life traumatic events, mental ill health, gender scales and IPV perpetration. Gender scales could predict IPV perpetration. Mental ill health symptoms could be comorbid and predict IPV perpetration. We fitted an SEM model based on known assumptions from the literature  and theThe sample comprised 2838 men who had been in heterosexual intimate relationships: 41% perpetrated IPV in lifetime and 8.8% perpetrated IPV in the 12\u00a0months before the survey. One in ten men had a score of 30 or above on the PTSD scale, 20.5% had a CESD score of 16 or more, 88.7% had experienced some form of child abuse.p\u2009=\u20090.0005). There was however no significant difference in IPV perpetration in past 12\u00a0months by age (p\u2009=\u20090.147). There was no significant difference in perpetration of lifetime or past 12\u00a0months IPV by men\u2019s highest educational attainment. More men who were employed in the last 12\u00a0months perpetrated violence than men who were not employed in the same period (p\u2009=\u20090.0007). A higher proportion of men who worked to earn income in the past 12\u00a0months perpetrated IPV in a similar period. A higher proportion of men who binge drank perpetrated IPV in lifetime (p\u2009=\u20090.0002) and in the past 12\u00a0months (p\u2009<\u20090.0001) than those who did not binge drink. A higher proportion of men who had 2 or more partners in the past 12\u00a0months perpetrated IPV in the same period than those who had less than two sexual partners (p\u2009=\u20090.0119).Table Table (Table ). Older men were more likely to perpetrate lifetime IPV compared to the 18\u201329\u00a0year olds. The risk for lifetime IPV perpetration increased with child trauma, traumatic life events, depression and PTSD symptom scores. Men who binge drank were 89% more likely to perpetrate IPV in lifetime compared to men who did not binge drink. Higher scores on the SRPS scales were protective of lifetime IPV perpetration.Table Table a. Older (Table ). Men who binge drank were 81% more likely to perpetrate IPV compared to the men who did not. Risk for IPV perpetration in past 12\u00a0months increased with PTSD symptoms. Higher scores on the SRPS scale were protective of past 12\u00a0months IPV perpetration (Table ).Factors associated with IPV in past 12\u00a0months were binge drinking, PTSD and sexual relationship power Table b. Men whon Table b.p value\u2009=\u2009<\u20090.0001).Figure\u00a0The study aimed to investigate the factors associated with men\u2019s use of violence against intimate partners. Factors associated with lifetime perpetration included child abuse, high gender inequity attitudes, binge drinking, life traumatic events, depressive symptoms and sexual relationship power. Factors associated with recent IPV perpetration included binge drinking, PTSD symptoms and less sexual relationship power. Path modelling of variables showed that child abuse had direct effects on PTSD, depression, gender attitudes and sexual relationship power. Sexual relationship power, binge drinking, PTSD and CESD had direct effects on IPV in past 12\u00a0months.The findings show the contribution of child abuse to IPV perpetration in a context where corporal punishment at home and in school institutions is legalized through Article 241 of the Criminal Law (Codification and Reform) Act 2004 and the Article 7 of the Children\u2019s Act 1972 . Child aChild abuse also had effects on gender attitudes and sexual relationship power. This is consistent with literature showing that men who were\u00a0 abused in childhood are more likely to\u00a0have witnessed parental violence and have been socialized into gender inequitable norms\u00a0leading to their \u00a0use violence in their intimate\u00a0 relationships . These fMental ill health among men was also shown to be a determinant of violence perpetration. Consistent with other research showing PTSD as a risk factor for IPV\u00a0 perpetration, , 18, 41 Notwithstanding, the data showed comorbidities between binge drinking and depression and that binge drinking fully-mediated the relationship with violence perpetration. Further investigations are necessary to understand these relationships because they provide an opportunity for intervening to reduce violence. The association of binge drinking with IPV perpetration can be explained by the distortion of perceptions of cues and lowering of inhibitions which lead to aggression in a relationship . ConsideThe data also shows that inequitable gender norms and behaviours associated with IPV are a key driver of violence perpetration. Gender norms are the result of socialization of individuals based on social expectations for appropriate behaviours of males and females. Society defines context specific models of manhood and these are passed onto boys and men through cultural processes. When norms are inequitable they negatively affect relationships with women and are often associated with partner violence . SexualiInequitable gender attitudes were also associated with sexual relationship power. The SRPS was developed to measure women\u2019s ability to negotiate safer sex practices and HIV risk as it relates to gender-based imbalances in the relationship . The assThe relationship between loss of economic power and perpetration of violence has been discussed in many settings . This exThere are several limitations to the study. The cross-sectional design limits the study in establishing temporality but the path analysis assists us to know how the factors are ordered and the directions in which variables are linked. We cannot conclude on the relationship between depression and IPV as there may be other factors associated with depression that were not measured in this study, for example, economic stressors. The observed relationships in this study are those that can be concluded based on the included variables only. The paper is based on men\u2019s self-report data which may have been affected by response bias such as unwillingness to disclose socially undesirable behaviors or characteristics. Nevertheless, the study methodology has its strengths which include having a nationwide coverage and a community based sample with sufficient power to generalize the findings.The study found high levels of lifetime male perpetration of intimate partner violence. Lifetime perpetration of IPV was associated with child abuse, high gender equity attitudes, binge drinking, life traumatic events, depressive symptoms and sexual relationship power. Factors associated with recent IPV perpetration were binge drinking, PTSD symptoms and less sexual relationship power. The causal pathway analysis found experiences of child abuse having a direct effect on PTSD, depressive symptoms, gender attitudes and sexual relationship power. PTSD, depressive symptoms, binge drinking and sexual relationship power had a direct effect on IPV in past 12\u00a0months.The public health implications of these findings are that primary prevention of IPV perpetration must focus on reducing child abuse by addressing negative parenting practices. Secondary prevention needs to address changing gender norms, promoting responsible behaviours, gender equitable masculinities as well as addressing mental ill health symptoms and alcohol abuse.", "texts": ["Over the years, researchers have relied on data from women victims to understand the profile on male perpetrators of intimate partner violence (IPV). IPV studies with male participants in the general population are still emerging in Africa. The contribution of mental ill health to IPV perpetration in the general population that has been documented elsewhere is emergent. Notwithstanding, research with male perpetrators is essential to informing effective prevention programmes and interventions. To contribute to the emerging literature on male perpetrators, we conducted a study to estimate the prevalence and factors associated with IPV perpetration by men in heterosexual relationships. We also modelled pathways to IPV perpetration using data from Zimbabwe.Data were collected through a nationwide survey employing a random and multi-staged sampling method. We recruited and administered a structured questionnaire to 2838 men aged 18\u00a0years and above. IPV was measured using an adapted WHO Domestic Violence Questionnaire. Determinants of IPV measured included child abuse, alcohol abuse, post-traumatic stress disorder (PTSD), depressive symptoms, personal gender attitudes and risky sexual behaviours. Multivariate regression modelling was used to assess factors associated with IPV perpetration. Structural equation modelling was used to explore the underlying pathways to recent IPV perpetration.Forty one percent of men had perpetrated IPV in their lifetime and 8.8% percent of men perpetrated IPV in the 12\u00a0months before the survey. Older, more educated men, men who binge drank, men who were abused as children or experienced other life traumatic experiences were more likely to perpetrate IPV in lifetime. Depressive symptoms and sexual relationship power (were also associated with lifetime IPV perpetration. IPV perpetration in the last 12\u00a0months was associated with binge drinking, PTSD and sexual relationship power. The pathways to IPV perpetration in the last 12\u00a0months from child abuse to recent IPV were mediated by comorbid PTSD symptoms, depression binge drinking and sexual relationship power.IPV perpetration was associated with child abuse history, mental ill health, sexual relationship power and personal gender attitudes. Interventions to reduce IPV need to engage men to address gender inequality, mental ill health and reduce alcohol consumption. According to the World Health Organisation, one in every three women (35%) across the globe have experienced some form of physical and or sexual violence perpetrated by their male intimate partner in their lifetime . PopulatUse of violence is more prevalent among men who endorse patriarchal norms supporting male dominance and sexual entitlement is more prevalent among men using violence . Men enaMental ill health, in particular, post-traumatic stress disorder has been shown to increase risk for IPV perpetration , 17. PTSResearch conducted in Zimbabwe with women shows that IPV is a prevalent societal problem \u201324. HoweThe study was a cross sectional national household survey conducted in 2012 in Zimbabwe. In the survey, participants were selected through a multi-stage random sampling method, using the 2002 Zimbabwe Population Census as the primary sampling frame. At the first sampling stage districts were sampled from all the 10 provinces using a proportionate to size method. At the district level, the primary sampling unit used were the Enumeration Areas (EAs). An enumeration area, also called a census block or census tract, is the smallest geographic unit for which census information is aggregated, compiled and disseminated. An enumeration area is defined by boundaries described on a sketch map or in a geographic information system (GIS) database . Again, The study was conducted in collaboration with and approved by the Government of Zimbabwe\u2019s Ministry of Women Affairs, Gender and Community Development (MWAGCD). Participation in the study was voluntary and prior written informed consent was given by all participants. Interviews were conducted in privacy and participants were assured of confidentiality. To ensure anonymity participants were assigned to random study ID numbers. Unlike studies of women\u2019s experiences of violence where risk for IPV after the interview is high and the need for counselling and support is much more pronounced , the plaData was collected through self-administered questionnaires loaded onto a personal digital assistant (PDA). Men aged 18 or older normally resident in the sampled household were recruited and interviewed by trained male researchers using structured questionnaires in a language chosen by the participant from English, Shona or Ndebele.. IPV experience in the past 12\u00a0months was measured using a follow-up question to each set of sub-scale questions for emotional, sexual and physical IPV as follows: \u201cHave any of these things happened in the past 12 months?\u201d The composite lifetime IPV variable was derived from combining the physical and/or sexual IPV and emotional IPV subscale items and if a man had done any of the acts towards a partner. A similar approach was used for the IPV past 12\u00a0months variable.The primary outcome of interest was lifetime sexual or physical IPV perpetration and these were measured using an adapted and pretested version of the WHO Multi-Country Study on Women\u2019s Health and Domestic Violence: Core Questionnaire and WHO Instrument \u2013 Version 9 designed for use in developing countries . Table\u00a01(Table 1). Responses to items were Never . R. R(TableTable ))  or No  to measure attitudes toward gender norms in intimate relationships and differing social expectations for men and women Table  32]. Re. Re32]. We used an adaptation of the Sexual Relationship Power Scale (SRPS) to measure power within sexual relationships. The scale consisted of relationship control items that predict sexual and physical violence, condom use and partner infidelity Table  33]. Re. Re33]. n\u2009=\u2009436). All data analyses were done using Stata version 13 considering the survey\u2019s multi-stage sample design. We used cross tabulations to describe the prevalence of lifetime and past 12\u00a0months IPV perpetration against the different sociodemographic variables, binge drinking, and sexual partners (Table\u00a02). For the continuous variables - Child abuse, CESD, PTSD, Life events, GEM and SRPS Scores, we used t-tests to compare the means across perpetrator vs non-perpetrator groups for both the lifetime IPV and past 12\u00a0months IPV (Table\u00a0).For this secondary analyses we excluded men who had never been in a heterosexual intimate relationship n\u2009=\u200946. All dap-value less than 0.2 in bivariate analyses into regression models. We controlled for the effect of sociodemographic variables  in models. We then used a stepwise backward elimination approach to eliminate non-significant associations until final models were arrived at that were parsimonious (Table\u00a0).To test for factors associated with lifetime and past 12\u00a0months IPV, we built logistic regression models. We included characteristics that had a us Table\u00a0.Table 4FFurther to the logistic regression modelling, we employed Structural Equation Modelling (SEM) with maximum likelihood estimation to investigate the underlying pathways of factors associated with recent/or 12\u00a0months IPV perpetration. Our a priori model was that there were significant inter-relationships between variables. Child abuse could be associated with life traumatic events, mental ill health, gender scales and IPV perpetration. Gender scales could predict IPV perpetration. Mental ill health symptoms could be comorbid and predict IPV perpetration. We fitted an SEM model based on known assumptions from the literature  and theThe sample comprised 2838 men who had been in heterosexual intimate relationships: 41% perpetrated IPV in lifetime and 8.8% perpetrated IPV in the 12\u00a0months before the survey. One in ten men had a score of 30 or above on the PTSD scale, 20.5% had a CESD score of 16 or more, 88.7% had experienced some form of child abuse.p\u2009=\u20090.0005). There was however no significant difference in IPV perpetration in past 12\u00a0months by age (p\u2009=\u20090.147). There was no significant difference in perpetration of lifetime or past 12\u00a0months IPV by men\u2019s highest educational attainment. More men who were employed in the last 12\u00a0months perpetrated violence than men who were not employed in the same period (p\u2009=\u20090.0007). A higher proportion of men who worked to earn income in the past 12\u00a0months perpetrated IPV in a similar period. A higher proportion of men who binge drank perpetrated IPV in lifetime (p\u2009=\u20090.0002) and in the past 12\u00a0months (p\u2009<\u20090.0001) than those who did not binge drink. A higher proportion of men who had 2 or more partners in the past 12\u00a0months perpetrated IPV in the same period than those who had less than two sexual partners (p\u2009=\u20090.0119).Table Table (Table ). Older men were more likely to perpetrate lifetime IPV compared to the 18\u201329\u00a0year olds. The risk for lifetime IPV perpetration increased with child trauma, traumatic life events, depression and PTSD symptom scores. Men who binge drank were 89% more likely to perpetrate IPV in lifetime compared to men who did not binge drink. Higher scores on the SRPS scales were protective of lifetime IPV perpetration.Table Table a. Older (Table ). Men who binge drank were 81% more likely to perpetrate IPV compared to the men who did not. Risk for IPV perpetration in past 12\u00a0months increased with PTSD symptoms. Higher scores on the SRPS scale were protective of past 12\u00a0months IPV perpetration (Table ).Factors associated with IPV in past 12\u00a0months were binge drinking, PTSD and sexual relationship power Table b. Men whon Table b.p value\u2009=\u2009<\u20090.0001).Figure\u00a0The study aimed to investigate the factors associated with men\u2019s use of violence against intimate partners. Factors associated with lifetime perpetration included child abuse, high gender inequity attitudes, binge drinking, life traumatic events, depressive symptoms and sexual relationship power. Factors associated with recent IPV perpetration included binge drinking, PTSD symptoms and less sexual relationship power. Path modelling of variables showed that child abuse had direct effects on PTSD, depression, gender attitudes and sexual relationship power. Sexual relationship power, binge drinking, PTSD and CESD had direct effects on IPV in past 12\u00a0months.The findings show the contribution of child abuse to IPV perpetration in a context where corporal punishment at home and in school institutions is legalized through Article 241 of the Criminal Law (Codification and Reform) Act 2004 and the Article 7 of the Children\u2019s Act 1972 . Child aChild abuse also had effects on gender attitudes and sexual relationship power. This is consistent with literature showing that men who were\u00a0 abused in childhood are more likely to\u00a0have witnessed parental violence and have been socialized into gender inequitable norms\u00a0leading to their \u00a0use violence in their intimate\u00a0 relationships . These fMental ill health among men was also shown to be a determinant of violence perpetration. Consistent with other research showing PTSD as a risk factor for IPV\u00a0 perpetration, , 18, 41 Notwithstanding, the data showed comorbidities between binge drinking and depression and that binge drinking fully-mediated the relationship with violence perpetration. Further investigations are necessary to understand these relationships because they provide an opportunity for intervening to reduce violence. The association of binge drinking with IPV perpetration can be explained by the distortion of perceptions of cues and lowering of inhibitions which lead to aggression in a relationship . ConsideThe data also shows that inequitable gender norms and behaviours associated with IPV are a key driver of violence perpetration. Gender norms are the result of socialization of individuals based on social expectations for appropriate behaviours of males and females. Society defines context specific models of manhood and these are passed onto boys and men through cultural processes. When norms are inequitable they negatively affect relationships with women and are often associated with partner violence . SexualiInequitable gender attitudes were also associated with sexual relationship power. The SRPS was developed to measure women\u2019s ability to negotiate safer sex practices and HIV risk as it relates to gender-based imbalances in the relationship . The assThe relationship between loss of economic power and perpetration of violence has been discussed in many settings . This exThere are several limitations to the study. The cross-sectional design limits the study in establishing temporality but the path analysis assists us to know how the factors are ordered and the directions in which variables are linked. We cannot conclude on the relationship between depression and IPV as there may be other factors associated with depression that were not measured in this study, for example, economic stressors. The observed relationships in this study are those that can be concluded based on the included variables only. The paper is based on men\u2019s self-report data which may have been affected by response bias such as unwillingness to disclose socially undesirable behaviors or characteristics. Nevertheless, the study methodology has its strengths which include having a nationwide coverage and a community based sample with sufficient power to generalize the findings.The study found high levels of lifetime male perpetration of intimate partner violence. Lifetime perpetration of IPV was associated with child abuse, high gender equity attitudes, binge drinking, life traumatic events, depressive symptoms and sexual relationship power. Factors associated with recent IPV perpetration were binge drinking, PTSD symptoms and less sexual relationship power. The causal pathway analysis found experiences of child abuse having a direct effect on PTSD, depressive symptoms, gender attitudes and sexual relationship power. PTSD, depressive symptoms, binge drinking and sexual relationship power had a direct effect on IPV in past 12\u00a0months.The public health implications of these findings are that primary prevention of IPV perpetration must focus on reducing child abuse by addressing negative parenting practices. Secondary prevention needs to address changing gender norms, promoting responsible behaviours, gender equitable masculinities as well as addressing mental ill health symptoms and alcohol abuse."]}
{"representative": "This study investigates the association between intimate partner violence (IPV) against women and its impact on child morbidity in the south Asian region.The analysis uses logistic regression models with cross sectional nationally representative data from three countries - Bangladesh, India and Nepal. The data have been pooled from \u2018Demographic and Health Surveys\u2019 (DHS) of Bangladesh, Nepal and \u2018National Family and Health Survey\u2019 (NFHS) of India.adj 1.57; 95 % CI 1.48\u20131.67), fever  and diarrhea .The study revealed that after controlling for potential confounders, children of mothers experiencing physical violence, sexual violence or both were more likely to have Acute Respiratory Infection (ARI) (ORThe results highlight that IPV can influence childhood morbidity and support the need to address IPV with a greater focus within current child nutrition and health programs and policies. During the last decade several studies investigated the impact of intimate partner violence (IPV) on children\u2019s health. A recent study by World Health Organization (WHO) shows that the global prevalence of physical and/or sexual intimate partner violence among all ever-partnered women was 30.0\u00a0% . The estEvidence is available on negative consequences of IPV for women\u2019s health and well-being . SeveralSignificant attention has also been dedicated to the potential negative role of IPV on the health and survival of infants. Some population based studies have reported considerable adverse effects of IPV upon gestational and birth outcomes . This alStudies on the association between IPV and childhood mortality are much more limited. Most of such studies come from developed countries. Scanty literature on this topic in the developing world includes some studies from India and one study from Bangladesh. Several studies from north India suggested significant association between lifetime IPV and infant mortality risks , 19, 23.Studies in Bangladesh convincingly showed that children of women exposed to IPV have greater exposure to potentially dangerous conditions like diarrhea and Acute Respiratory Infection (ARI) , 36. ImpThe current study builds upon the existing literature and explores association between IPV and childhood morbidity expanding the study beyond a single country to include three neighboring countries in South Asia, i.e., Bangladesh, India and Nepal.The study uses three datasets \u2013 BangladThis secondary analysis includes a total of 40,394 women from India, Bangladesh and Nepal. The women selected for the violence module had at least one child under the age of 5\u00a0years during the survey. We included all the children under the age of 5\u00a0years in this sample. Therefore a total number of 58,725 children of these women were included in the study.The original survey was administrated in accordance with the WHO ethical and safety guidelines for research on IPV. The institution review board of ICF Macro , an advisory, implementation, and evaluation services firm providing research-based solutions to U.S. federal government agencies in health and other areas. Reviewed and approved the surveys used in the study. The interviewers received special training to implement this module. The training focused on how to ask sensitive questions, ensure privacy, and build rapport between interviewer and respondent. Verbal Informed consent was also obtained from the respondents. Details of the informed consent statement can be found in the appendix section of the respective reports , 27, 29.This study considers IPV as the main exposure variable while child morbidity as the outcome of interest.i.Has your husband pushed, shook or threw something?ii.Has your husband slapped you?iii.Has your husband twisted your arm or pulled your hair?iv.Has your husband punched with fist or something harmful?v.Has your husband kicked you, dragged you or beaten you up?vi.Have you been threatened by a weapon or had a weapon used against you by your husband? Has your husband been choked you or burn you on purpose?vii.Have you been physically forced to have sex or otherwise sexually abused by your husband?Women were asked the following questions about their experience of IPV involving their husbands over the past 12\u00a0months.A new dummy IPV variable was created based on the answer to the above questions. A positive response to any one of the first six questions was treated as indicative of physical IPV victimization and was coded as \u201c1\u201d and if none of the responses was positive, exposure to physical violence was coded as \u201c0\u201d. A similar strategy was followed for deriving a variable indicating exposure or non-exposure to sexual IPV. Then two more variables were created to indicate exposure to any IPV or both IPV.Women were asked whether their child had been ill with fever, diarrhea, or a cough accompanied by short, rapid breathing in the 2\u00a0weeks prior to the surveys. Acute Respiratory Infection (ARI) was defined as the presence of cough, along with short, rapid breathing. Binary variables for Diarrhea, ARI and Fever were created which indicated the presence of each of these outcomes among the children in the past 2\u00a0weeks prior the survey. For these cases, \u201c0\u201d indicated absence of the symptoms while \u201c1\u201d indicated presence of the same.The study controlled for well established correlates of child morbidity such as age, religion, education, living standard, employment status and areas of residence , 27, 29.Respondent\u2019s age was classified into 5 groups. The respondents were asked if they attended any educational institution and if yes then the highest level completed  was asked. We used the information to classify education of the mother into the following categories: .Respondents were asked about the main source of drinking water for their household and presented with options like piped water, tube well or borehole, dug well, spring water, surface water etc. The responses were grouped into three major categories: Tube well or borehole, piped water and other sources. Women were asked about the toilet facility and the responses were classified in the groups of pit latrine, flush and no facility. Cooking fuel of the household was classified into: electricity, gas, kerosene, wood/coal and others.We used the DHS wealth index calculated as follows: each asset was assigned a weight (factor score) generated through principal component analysis, and the resulting asset scores were standardized in relation to a normal distribution with a mean of zero and standard deviation of one. Each household was then assigned a score for each asset, and the scores were summed for each household; individuals were ranked according to the total score of the household in which they resided. The sample was then divided into quintiles from one (lowest) to five (highest).We calculated descriptive statistics for socio-demographic and morbidity characteristics for our selected sample individuals. The relationhip between morbidity and selected demographic and socio-economic factors were examined first using chi-square test. Then we used logistic regression models for exploring the relationship between IPV and different child morbidity outcomes. After this step we ran multiple logistic regression analysis. We calculated the adjusted odds ratio to measure the strength of associations. SPSS version 17 was used for the analysis.Background characteristics of the women and their children are presented in Table\u00a0p\u2009<\u20090.001).In Table\u00a0Table\u00a0The results show that Maternal experience of physical IPV increased the likelihood of child fever by 46\u00a0% , sexual IPV by 67\u00a0% , and both physical and sexual IPV by 64\u00a0% .Maternal exposure to physical IPV increased the risks of diarrhea of the child by 55\u00a0% , sexual IPV by 79\u00a0%  and both physical and sexual IPV by 66\u00a0% .Maternal experience of physical IPV increased the likelihood of child\u2019s ARI by 53\u00a0%  sexual IPV by 72\u00a0%  and both physical and sexual IPV by 76\u00a0% .Poor mental health of the mother: Women who experience IPV tend to have higher level of psychological stress , 26 whicLack of empowerment: Intimate partner violence is often used as a tool for controlling women . Thus IPPoor physical condition of the mother: In case of extreme IPV often the victims become physically unfit to give proper care to their children.The central aim of this study was to investigate the association between Intimate Partner Violence against women and child morbidity in South. The results of the study provide evidence of an association between IPV and child morbidity in these three countries of South Asia. The results are in line with previous findings , 35, 36.Besides, the children who witness IPV themselves tend to experience psychological stress; which in turn result in poor physiological conditions making the children vulnerable to morbidity , 11, 22.The cross sectional study design represents a limitation of this study. Though there may be some concern regarding the temporal ordering of IPV and child morbidity in cross sectional studies, previous research shows that IPV in this subcontinent is a relatively stable phenomenon that has its root in patriarchal structures and community norms of high acceptability of wife beating .Another limitation of the study is that both the outcome and the exposure variables are measured through self reports. Although in the DHS much care and preparation is taken into the design and execution of the interviews to create a safe atmosphere in which respondents would feel comfortable discussing the IPV, high stake in disclosure may always cause under reporting.The study shows that IPV negatively affects child\u2019s health not only in individual countries, but also in the South Asia region. The children of an abused mother are more likely to experience diseases like fever, diarrhea and ARI compared to the children of non-abused mothers. IPV should be considered as a major health problem affecting not only women, but also their children in South Asia. Although it seems IPV is most strongly associated with socioeconomic demographic and contextual disadvantages, incidents of IPV among socially marginalized groups may aggravate the negative effects of cumulative disadvantages of poor child health outcomes. The health sector in these countries needs to take action to eliminate IPV for improving child health. Future studies should investigate the influence of potential mechanisms mediating the association of IPV and child morbidity.", "texts": ["This study investigates the association between intimate partner violence (IPV) against women and its impact on child morbidity in the south Asian region.The analysis uses logistic regression models with cross sectional nationally representative data from three countries - Bangladesh, India and Nepal. The data have been pooled from \u2018Demographic and Health Surveys\u2019 (DHS) of Bangladesh, Nepal and \u2018National Family and Health Survey\u2019 (NFHS) of India.adj 1.57; 95 % CI 1.48\u20131.67), fever  and diarrhea .The study revealed that after controlling for potential confounders, children of mothers experiencing physical violence, sexual violence or both were more likely to have Acute Respiratory Infection (ARI) (ORThe results highlight that IPV can influence childhood morbidity and support the need to address IPV with a greater focus within current child nutrition and health programs and policies. During the last decade several studies investigated the impact of intimate partner violence (IPV) on children\u2019s health. A recent study by World Health Organization (WHO) shows that the global prevalence of physical and/or sexual intimate partner violence among all ever-partnered women was 30.0\u00a0% . The estEvidence is available on negative consequences of IPV for women\u2019s health and well-being . SeveralSignificant attention has also been dedicated to the potential negative role of IPV on the health and survival of infants. Some population based studies have reported considerable adverse effects of IPV upon gestational and birth outcomes . This alStudies on the association between IPV and childhood mortality are much more limited. Most of such studies come from developed countries. Scanty literature on this topic in the developing world includes some studies from India and one study from Bangladesh. Several studies from north India suggested significant association between lifetime IPV and infant mortality risks , 19, 23.Studies in Bangladesh convincingly showed that children of women exposed to IPV have greater exposure to potentially dangerous conditions like diarrhea and Acute Respiratory Infection (ARI) , 36. ImpThe current study builds upon the existing literature and explores association between IPV and childhood morbidity expanding the study beyond a single country to include three neighboring countries in South Asia, i.e., Bangladesh, India and Nepal.The study uses three datasets \u2013 BangladThis secondary analysis includes a total of 40,394 women from India, Bangladesh and Nepal. The women selected for the violence module had at least one child under the age of 5\u00a0years during the survey. We included all the children under the age of 5\u00a0years in this sample. Therefore a total number of 58,725 children of these women were included in the study.The original survey was administrated in accordance with the WHO ethical and safety guidelines for research on IPV. The institution review board of ICF Macro , an advisory, implementation, and evaluation services firm providing research-based solutions to U.S. federal government agencies in health and other areas. Reviewed and approved the surveys used in the study. The interviewers received special training to implement this module. The training focused on how to ask sensitive questions, ensure privacy, and build rapport between interviewer and respondent. Verbal Informed consent was also obtained from the respondents. Details of the informed consent statement can be found in the appendix section of the respective reports , 27, 29.This study considers IPV as the main exposure variable while child morbidity as the outcome of interest.i.Has your husband pushed, shook or threw something?ii.Has your husband slapped you?iii.Has your husband twisted your arm or pulled your hair?iv.Has your husband punched with fist or something harmful?v.Has your husband kicked you, dragged you or beaten you up?vi.Have you been threatened by a weapon or had a weapon used against you by your husband? Has your husband been choked you or burn you on purpose?vii.Have you been physically forced to have sex or otherwise sexually abused by your husband?Women were asked the following questions about their experience of IPV involving their husbands over the past 12\u00a0months.A new dummy IPV variable was created based on the answer to the above questions. A positive response to any one of the first six questions was treated as indicative of physical IPV victimization and was coded as \u201c1\u201d and if none of the responses was positive, exposure to physical violence was coded as \u201c0\u201d. A similar strategy was followed for deriving a variable indicating exposure or non-exposure to sexual IPV. Then two more variables were created to indicate exposure to any IPV or both IPV.Women were asked whether their child had been ill with fever, diarrhea, or a cough accompanied by short, rapid breathing in the 2\u00a0weeks prior to the surveys. Acute Respiratory Infection (ARI) was defined as the presence of cough, along with short, rapid breathing. Binary variables for Diarrhea, ARI and Fever were created which indicated the presence of each of these outcomes among the children in the past 2\u00a0weeks prior the survey. For these cases, \u201c0\u201d indicated absence of the symptoms while \u201c1\u201d indicated presence of the same.The study controlled for well established correlates of child morbidity such as age, religion, education, living standard, employment status and areas of residence , 27, 29.Respondent\u2019s age was classified into 5 groups. The respondents were asked if they attended any educational institution and if yes then the highest level completed  was asked. We used the information to classify education of the mother into the following categories: .Respondents were asked about the main source of drinking water for their household and presented with options like piped water, tube well or borehole, dug well, spring water, surface water etc. The responses were grouped into three major categories: Tube well or borehole, piped water and other sources. Women were asked about the toilet facility and the responses were classified in the groups of pit latrine, flush and no facility. Cooking fuel of the household was classified into: electricity, gas, kerosene, wood/coal and others.We used the DHS wealth index calculated as follows: each asset was assigned a weight (factor score) generated through principal component analysis, and the resulting asset scores were standardized in relation to a normal distribution with a mean of zero and standard deviation of one. Each household was then assigned a score for each asset, and the scores were summed for each household; individuals were ranked according to the total score of the household in which they resided. The sample was then divided into quintiles from one (lowest) to five (highest).We calculated descriptive statistics for socio-demographic and morbidity characteristics for our selected sample individuals. The relationhip between morbidity and selected demographic and socio-economic factors were examined first using chi-square test. Then we used logistic regression models for exploring the relationship between IPV and different child morbidity outcomes. After this step we ran multiple logistic regression analysis. We calculated the adjusted odds ratio to measure the strength of associations. SPSS version 17 was used for the analysis.Background characteristics of the women and their children are presented in Table\u00a0p\u2009<\u20090.001).In Table\u00a0Table\u00a0The results show that Maternal experience of physical IPV increased the likelihood of child fever by 46\u00a0% , sexual IPV by 67\u00a0% , and both physical and sexual IPV by 64\u00a0% .Maternal exposure to physical IPV increased the risks of diarrhea of the child by 55\u00a0% , sexual IPV by 79\u00a0%  and both physical and sexual IPV by 66\u00a0% .Maternal experience of physical IPV increased the likelihood of child\u2019s ARI by 53\u00a0%  sexual IPV by 72\u00a0%  and both physical and sexual IPV by 76\u00a0% .Poor mental health of the mother: Women who experience IPV tend to have higher level of psychological stress , 26 whicLack of empowerment: Intimate partner violence is often used as a tool for controlling women . Thus IPPoor physical condition of the mother: In case of extreme IPV often the victims become physically unfit to give proper care to their children.The central aim of this study was to investigate the association between Intimate Partner Violence against women and child morbidity in South. The results of the study provide evidence of an association between IPV and child morbidity in these three countries of South Asia. The results are in line with previous findings , 35, 36.Besides, the children who witness IPV themselves tend to experience psychological stress; which in turn result in poor physiological conditions making the children vulnerable to morbidity , 11, 22.The cross sectional study design represents a limitation of this study. Though there may be some concern regarding the temporal ordering of IPV and child morbidity in cross sectional studies, previous research shows that IPV in this subcontinent is a relatively stable phenomenon that has its root in patriarchal structures and community norms of high acceptability of wife beating .Another limitation of the study is that both the outcome and the exposure variables are measured through self reports. Although in the DHS much care and preparation is taken into the design and execution of the interviews to create a safe atmosphere in which respondents would feel comfortable discussing the IPV, high stake in disclosure may always cause under reporting.The study shows that IPV negatively affects child\u2019s health not only in individual countries, but also in the South Asia region. The children of an abused mother are more likely to experience diseases like fever, diarrhea and ARI compared to the children of non-abused mothers. IPV should be considered as a major health problem affecting not only women, but also their children in South Asia. Although it seems IPV is most strongly associated with socioeconomic demographic and contextual disadvantages, incidents of IPV among socially marginalized groups may aggravate the negative effects of cumulative disadvantages of poor child health outcomes. The health sector in these countries needs to take action to eliminate IPV for improving child health. Future studies should investigate the influence of potential mechanisms mediating the association of IPV and child morbidity."]}
{"representative": "A combination of intimate partner violence (IPV) and depression is a common feature of the perinatal period globally. Understanding this association can provide indications of how IPV can be addressed or prevented during pregnancy. This paper aims to determine the prevalence and correlates of IPV among pregnant low-income women with depressive symptoms in Khayelitsha, South Africa, and changes in IPV reports during the course of the perinatal period.This study is a secondary analysis of data collected as part of a randomised controlled trial testing a psychosocial intervention for antenatal depression. IPV, socio-demographic measures, depression and other mental health measures were collected at recruitment , 8 months gestation, and 3 and 12 months postpartum. IPV was defined as a sexual or physical violence perpetrated by the participant's partner in the past 3 months. Descriptive statistics are reported.Of 425 recruited depressed participants, 59 (13.9%) reported IPV at baseline, with physical IPV being the most frequently reported (69.5%). Reported IPV was associated with greater emotional distress, potentially higher food insecurity and higher rates of alcohol abuse. There were clear longitudinal trends in reported IPV with the majority of women no longer reporting IPV postpartum. However, some women reported IPV at later assessment points after not reporting IPV at baseline.There is a strong association between IPV and depression in pregnancy. IPV reports remit over time for the women in this study, although the reason for this reduction is not clear and requires further investigation. If participants reported IPV, they were encouraged to report it to their local police station. If a woman reported suicidal ideation or behaviour, she was referred to the clinic psychiatric nurse for further assessment and management.The full sample enrolled in the AFFIRM-SA trial , 8 months gestation, 3 months postpartum and 12 months postpartum. The measures collected at all assessment time points are described in the AFFIRM-SA RCT protocol  the victim of physical violence in the last 3 months ; and (2) the victim of sexual violence in the last 3 months. If participants answered affirmatively to one or both questions, they were asked by whom. Physical or sexual IPV was defined as responding yes to the first or second question, respectively, and specifying the violence was perpetrated by the partner. As stated earlier, we did not include verbal abuse as it usually coincides with either physical or sexual abuse (Mitchell https://www.mobenzi.com), which minimised missing data for completed assessments. Attrition at follow-up ranged between 21 and 29%, and was highest at the 8-month gestation assessment. The main reasons for missed assessments were because of having given birth (for 8-month gestation assessment), not being contactable or refusal to continue their participation. Participants were suspended from the trial if they had a miscarriage or stillbirth, but were offered continued counselling outside of the trial intervention.Data collected as part of the assessments were captured on an android mobile device system  results of the RCT suggest that the intervention and control arms showed little difference in depressive symptoms at 3 months postpartum, the primary outcome measure. For this reason, the two arms were combined and analysed as one group for the purpose of this study. No imputation was conducted to address missing assessments.U tests were performed to assess continuous correlates of IPV at baseline and continuous infant and maternal outcomes at 3 months postpartum. Correlates of the incidence of IPV later in pregnancy or postpartum v. those who never reported IPV were investigated using the Kruskal\u2013Wallis test.Given the small sample of women reporting different forms of IPV at baseline, physical and sexual IPV were analysed together and only descriptive analyses and non-parametric univariate analyses were conducted. The Fisher's exact test was used to assess baseline categorical variables in relation to IPV at baseline or the incidence of IPV later in pregnancy or postpartum. The same test was used to compare categorical birth, infant and maternal outcomes at 3 months postpartum between participants reporting IPV during pregnancy and those who did not. Mann\u2013Whitney The child and maternal outcomes assessed at 12 months postnatal assessment were not included in these analyses, since we could not control for potential confounders.n\u00a0=\u00a0235, 55.3%) with a mean age of 27.3 years (s.d.\u00a0=\u00a05.72). Nearly all women reported having a partner , but only a third actually lived with their partner (34.8%). Approximately 40% of the sample had finished secondary education, and nearly half were employed at the time of recruitment . Participants in the study all had symptoms of depression based on the EPDS (as per the inclusion criteria). However, 41.4% were diagnosed with clinical depression on the MINI, and 17.4% were considered at high risk of suicide.Out of the 425 participants, 59 participants (13.9%) reported having experienced physical and/or sexual IPV in the past 3 months at baseline: 52 (12.2%) reported physical IPV and 18 (4.2%) reported sexual IPV. Altogether, 11 (2.6%) participants reported experiencing both forms of IPV. 2\u00a0=\u00a06.20, p\u00a0<\u00a00.05). There were no other demographic differences between the two groups, though a marginally greater proportion of those who reported IPV had a lower education level and greater food insecurity.U\u00a0=\u00a0\u22122.95, p\u00a0<\u00a00.05), EPDS  and the AUDIT , compared with participants who did not report IPV . Finally, as measured by the MINI, nearly twice as many participants who reported IPV received a diagnosis of depression  and were at a significantly high risk of suicide , compared with participants not experiencing IPV . The two groups did not differ on levels of impaired functioning or on their perceived level of social support.Clinically, however, participants who experienced IPV at baseline had significantly worse symptoms (i.e. higher scores) on the HAM-D . Of these, one reported no longer being with a partner at the 8-month gestation assessment, and a further 10 reported no longer being with a partner at the time of the 3-month postpartum assessment. This suggests that the reported IPV subsided before the person separated from their partner. Over a quarter of participants , however, continued to experience IPV during the postpartum period. Of those who did not experience IPV at baseline , 12.8% (n\u00a0=\u00a047) went on to report IPV in later assessments, either later in pregnancy  or in the postpartum period .Of participants who reported IPV at baseline, the majority no longer reported experiencing IPV at 3 months post-partum . Results suggest that a greater proportion of participants who lived with their partners at baseline reported IPV starting at the end of pregnancy (8.4%), compared with those who did not live with their partner (1.6%) . A greater proportion of participants who were employed at baseline reported the incidence of IPV at the end of pregnancy (6.2%), rather than in the postnatal period (5.2%) . The opposite was true for those who were unemployed at baseline, with 2.0% reporting the incidence of IPV late in pregnancy, and 11.2% postpartum . Age was also marginally associated with the incidence of IPV: older participants (aged 31 years or more) were more likely to experience IPV later in pregnancy. None of the younger participants (aged 18\u201321) reported IPV before birth, but the incidence of IPV postpartum was highest in this younger age group.H\u00a0=\u00a012.34, p\u00a0<\u00a00.01), compared with the other two groups . A similar, but marginal trend was found for HAM-D scores: participants who reported IPV postpartum had marginally greater baseline HAM-D scores compared with those who never reported IPV, or those who reported the incidence of IPV later in pregnancy. Finally, a marginally greater proportion of women diagnosed with depression at baseline reported the incidence of IPV, both before and after birth , compared with those who were not diagnosed with depression .Participants who reported postnatal incidence of IPV had significantly greater AUDIT scores at baseline  and those who did not . No diffU\u00a0=\u00a0\u22122.84, p\u00a0<\u00a00.05) and the EPDS , compared with those who never reported IPV .No differences were found between the two groups, either in terms of anthropometric characteristics, breastfeeding length or health problems. Differences were found in relation to maternal clinical symptoms, however. Participants who reported IPV during pregnancy had greater depressive symptoms at 3 months postpartum, as measured by the HAM-D  of the sample of pregnant women with depressive symptoms, with the majority of these being physical IPV. Limited comparisons can be made between the prevalence of IPV reported in this study to that of other studies, as most studies investigated trends among all pregnant women. However, there is evidence that pregnant women who are depressed report higher rates of IPV than those not depressed when screening all pregnant women. Connelly et al.  range from 5 to 20% in low- and middle-income contexts  predictors of IPV later in pregnancy and postpartum, and IPV during pregnancy predicted high depressive symptoms at 3 months postpartum. However, the small sample and non-parametric analyses mean that we need to be cautious about these findings, as the small sample size did not allow for multivariate analyses, and so we could not control for any confounders.v. no IPV during pregnancy. This could be due to the small sample and the lack of variation across these measures in the overall sample. It could also be explained in part by the nature of the cohort, in that all participants were already compromised because of their depressive symptoms, which themselves are associated with adverse birth outcomes  do not differ much in terms of demographic characteristics. They do, however, differ in terms of depressive symptoms and alcohol use behaviours: participants who report IPV starting postpartum had greater depressive and alcohol abuse symptoms at baseline than participants who report IPV during the course of pregnancy. The reasons for this are not clear and could be elucidated through further research more specifically targeted at IPV in the perinatal period and specifically following up women postpartum.The two IPV groups . This suggests that IPV may have been present before worsening of depressive symptoms.et al.The profile of the participants reporting any IPV in our study reflect a high degree of vulnerability, with greater emotional distress, a tendency towards higher food insecurity and higher rates of alcohol abuse, compared with women without IPV. These concur with profiles reported in other studies, with food insecurity and unemployment being common aspects associated with the reports of IPV  and by the Western Cape Department of Health and health facilities involved in the trial. Each participant signed an informed consent form before being recruited into the study.", "texts": ["A combination of intimate partner violence (IPV) and depression is a common feature of the perinatal period globally. Understanding this association can provide indications of how IPV can be addressed or prevented during pregnancy. This paper aims to determine the prevalence and correlates of IPV among pregnant low-income women with depressive symptoms in Khayelitsha, South Africa, and changes in IPV reports during the course of the perinatal period.This study is a secondary analysis of data collected as part of a randomised controlled trial testing a psychosocial intervention for antenatal depression. IPV, socio-demographic measures, depression and other mental health measures were collected at recruitment , 8 months gestation, and 3 and 12 months postpartum. IPV was defined as a sexual or physical violence perpetrated by the participant's partner in the past 3 months. Descriptive statistics are reported.Of 425 recruited depressed participants, 59 (13.9%) reported IPV at baseline, with physical IPV being the most frequently reported (69.5%). Reported IPV was associated with greater emotional distress, potentially higher food insecurity and higher rates of alcohol abuse. There were clear longitudinal trends in reported IPV with the majority of women no longer reporting IPV postpartum. However, some women reported IPV at later assessment points after not reporting IPV at baseline.There is a strong association between IPV and depression in pregnancy. IPV reports remit over time for the women in this study, although the reason for this reduction is not clear and requires further investigation. If participants reported IPV, they were encouraged to report it to their local police station. If a woman reported suicidal ideation or behaviour, she was referred to the clinic psychiatric nurse for further assessment and management.The full sample enrolled in the AFFIRM-SA trial , 8 months gestation, 3 months postpartum and 12 months postpartum. The measures collected at all assessment time points are described in the AFFIRM-SA RCT protocol  the victim of physical violence in the last 3 months ; and (2) the victim of sexual violence in the last 3 months. If participants answered affirmatively to one or both questions, they were asked by whom. Physical or sexual IPV was defined as responding yes to the first or second question, respectively, and specifying the violence was perpetrated by the partner. As stated earlier, we did not include verbal abuse as it usually coincides with either physical or sexual abuse (Mitchell https://www.mobenzi.com), which minimised missing data for completed assessments. Attrition at follow-up ranged between 21 and 29%, and was highest at the 8-month gestation assessment. The main reasons for missed assessments were because of having given birth (for 8-month gestation assessment), not being contactable or refusal to continue their participation. Participants were suspended from the trial if they had a miscarriage or stillbirth, but were offered continued counselling outside of the trial intervention.Data collected as part of the assessments were captured on an android mobile device system  results of the RCT suggest that the intervention and control arms showed little difference in depressive symptoms at 3 months postpartum, the primary outcome measure. For this reason, the two arms were combined and analysed as one group for the purpose of this study. No imputation was conducted to address missing assessments.U tests were performed to assess continuous correlates of IPV at baseline and continuous infant and maternal outcomes at 3 months postpartum. Correlates of the incidence of IPV later in pregnancy or postpartum v. those who never reported IPV were investigated using the Kruskal\u2013Wallis test.Given the small sample of women reporting different forms of IPV at baseline, physical and sexual IPV were analysed together and only descriptive analyses and non-parametric univariate analyses were conducted. The Fisher's exact test was used to assess baseline categorical variables in relation to IPV at baseline or the incidence of IPV later in pregnancy or postpartum. The same test was used to compare categorical birth, infant and maternal outcomes at 3 months postpartum between participants reporting IPV during pregnancy and those who did not. Mann\u2013Whitney The child and maternal outcomes assessed at 12 months postnatal assessment were not included in these analyses, since we could not control for potential confounders.n\u00a0=\u00a0235, 55.3%) with a mean age of 27.3 years (s.d.\u00a0=\u00a05.72). Nearly all women reported having a partner , but only a third actually lived with their partner (34.8%). Approximately 40% of the sample had finished secondary education, and nearly half were employed at the time of recruitment . Participants in the study all had symptoms of depression based on the EPDS (as per the inclusion criteria). However, 41.4% were diagnosed with clinical depression on the MINI, and 17.4% were considered at high risk of suicide.Out of the 425 participants, 59 participants (13.9%) reported having experienced physical and/or sexual IPV in the past 3 months at baseline: 52 (12.2%) reported physical IPV and 18 (4.2%) reported sexual IPV. Altogether, 11 (2.6%) participants reported experiencing both forms of IPV. 2\u00a0=\u00a06.20, p\u00a0<\u00a00.05). There were no other demographic differences between the two groups, though a marginally greater proportion of those who reported IPV had a lower education level and greater food insecurity.U\u00a0=\u00a0\u22122.95, p\u00a0<\u00a00.05), EPDS  and the AUDIT , compared with participants who did not report IPV . Finally, as measured by the MINI, nearly twice as many participants who reported IPV received a diagnosis of depression  and were at a significantly high risk of suicide , compared with participants not experiencing IPV . The two groups did not differ on levels of impaired functioning or on their perceived level of social support.Clinically, however, participants who experienced IPV at baseline had significantly worse symptoms (i.e. higher scores) on the HAM-D . Of these, one reported no longer being with a partner at the 8-month gestation assessment, and a further 10 reported no longer being with a partner at the time of the 3-month postpartum assessment. This suggests that the reported IPV subsided before the person separated from their partner. Over a quarter of participants , however, continued to experience IPV during the postpartum period. Of those who did not experience IPV at baseline , 12.8% (n\u00a0=\u00a047) went on to report IPV in later assessments, either later in pregnancy  or in the postpartum period .Of participants who reported IPV at baseline, the majority no longer reported experiencing IPV at 3 months post-partum . Results suggest that a greater proportion of participants who lived with their partners at baseline reported IPV starting at the end of pregnancy (8.4%), compared with those who did not live with their partner (1.6%) . A greater proportion of participants who were employed at baseline reported the incidence of IPV at the end of pregnancy (6.2%), rather than in the postnatal period (5.2%) . The opposite was true for those who were unemployed at baseline, with 2.0% reporting the incidence of IPV late in pregnancy, and 11.2% postpartum . Age was also marginally associated with the incidence of IPV: older participants (aged 31 years or more) were more likely to experience IPV later in pregnancy. None of the younger participants (aged 18\u201321) reported IPV before birth, but the incidence of IPV postpartum was highest in this younger age group.H\u00a0=\u00a012.34, p\u00a0<\u00a00.01), compared with the other two groups . A similar, but marginal trend was found for HAM-D scores: participants who reported IPV postpartum had marginally greater baseline HAM-D scores compared with those who never reported IPV, or those who reported the incidence of IPV later in pregnancy. Finally, a marginally greater proportion of women diagnosed with depression at baseline reported the incidence of IPV, both before and after birth , compared with those who were not diagnosed with depression .Participants who reported postnatal incidence of IPV had significantly greater AUDIT scores at baseline  and those who did not . No diffU\u00a0=\u00a0\u22122.84, p\u00a0<\u00a00.05) and the EPDS , compared with those who never reported IPV .No differences were found between the two groups, either in terms of anthropometric characteristics, breastfeeding length or health problems. Differences were found in relation to maternal clinical symptoms, however. Participants who reported IPV during pregnancy had greater depressive symptoms at 3 months postpartum, as measured by the HAM-D  of the sample of pregnant women with depressive symptoms, with the majority of these being physical IPV. Limited comparisons can be made between the prevalence of IPV reported in this study to that of other studies, as most studies investigated trends among all pregnant women. However, there is evidence that pregnant women who are depressed report higher rates of IPV than those not depressed when screening all pregnant women. Connelly et al.  range from 5 to 20% in low- and middle-income contexts  predictors of IPV later in pregnancy and postpartum, and IPV during pregnancy predicted high depressive symptoms at 3 months postpartum. However, the small sample and non-parametric analyses mean that we need to be cautious about these findings, as the small sample size did not allow for multivariate analyses, and so we could not control for any confounders.v. no IPV during pregnancy. This could be due to the small sample and the lack of variation across these measures in the overall sample. It could also be explained in part by the nature of the cohort, in that all participants were already compromised because of their depressive symptoms, which themselves are associated with adverse birth outcomes  do not differ much in terms of demographic characteristics. They do, however, differ in terms of depressive symptoms and alcohol use behaviours: participants who report IPV starting postpartum had greater depressive and alcohol abuse symptoms at baseline than participants who report IPV during the course of pregnancy. The reasons for this are not clear and could be elucidated through further research more specifically targeted at IPV in the perinatal period and specifically following up women postpartum.The two IPV groups . This suggests that IPV may have been present before worsening of depressive symptoms.et al.The profile of the participants reporting any IPV in our study reflect a high degree of vulnerability, with greater emotional distress, a tendency towards higher food insecurity and higher rates of alcohol abuse, compared with women without IPV. These concur with profiles reported in other studies, with food insecurity and unemployment being common aspects associated with the reports of IPV  and by the Western Cape Department of Health and health facilities involved in the trial. Each participant signed an informed consent form before being recruited into the study."]}
{"representative": "Intimate partner violence (IPV) experienced by pregnant and post-partum women has negative health effects for women, as well as the foetus, and the new-born child. In this study we sought to assess the prevalence and factors associated with recent IPV amongst post-partum women in one clinic in eThekwini Municipality, South Africa, and explore the relationship between IPV, depression and functional limitations/disabilities. Past 12 month IPV-victimisation was 10.55%. Logistic regression modelled relationships between IPV, functional limitations, depressive symptoms, socio-economic measures, and sexual relationship power. In logistic regression models, overall severity of functional limitations were not associated with IPV-victimisation when treated as a continuous overall score. In this model relationship power  and depressive symptoms  were significant. When the different functional limitations were separated out in a second model, significant factors were relationship power , depressive symptoms  and mobility limitations . The study emphasises that not all functional limitations are associated with IPV-experience, that depression and disability while overlapping can also be considered different drivers of vulnerability, and that women\u2019s experience of IPV is not dependent on pregnancy specific factors, but rather wider social factors that all women experience. IPV during pregnancy and in the post-partum period is relatively common globally . The preExperiencing IPV is not only a human rights violation, but also has profound health and social consequences for women . Women wExperiencing IPV during pregnancy and in the post-partum period has not only serious health and social consequences for women, but also negative implications for the developing foetus and the new-born child, such as higher levels of pre-term birth and lower birth weight compared to women not exposed to violence during pregnancy .Research investigating the factors driving women\u2019s experiences of IPV have been linked to gender inequalities, whereby women have less social, economic and political power than men and this social and economic dependency places them at risk of IPV-victimisation , 12. ForWomen may experience additional vulnerabilities to IPV-victimisation during pregnancy. One risk factor is whether the pregnancy was unintended . In addiAlthough depression is a potential consequence of IPV it has also been identified as a risk factor for experiencing IPV . Recent In addition, recent research also suggest a strong association between IPV and disability, a factor that has not been widely investigated in mainstream IPV research. A global systematic review on violence among people with disabilities highlighted that this population are more likely to experience IPV than people without disabilities , 20. ThiAdditionally there may be a complex relationship between disability and depression. Depression is a health condition that can lead to disability through limitations in activities and participation in society . Work amIn this paper, we sought 1) to understand the prevalence and factors associated with IPV amongst post-partum women in one clinic in eThekwini Municipality, South Africa. And 2) to understand the associations between IPV and, depression, and disability in this population amongst women experiencing IPV and those not.This was a cross-sectional study, conducted in one public sector primary healthcare facility serving a large, urban informal settlement in eThekwini Municipality, South Africa. The community is characterized by dense informal dwellings, high levels of poverty, lack of access to formal sanitation and water, and generalized high levels of violence. In addition, 41% of women attending antenatal care in eThekwini Municipality, are estimated to be living with HIV .All participants were aged 18 or older and were biological mothers of infants six weeks old or younger. Women were consecutively recruited from January to March 2015. Within the clinic all women were screened (if they consented) while waiting in a queue to be seen by the health provider. If women agreed and met the eligibility criteria, they were directed to be interviewed by research assistants after their clinic visit. All enrolled participants were given ZAR100 as remuneration for their time and transport. All participants provided written informed consent.Ethical clearance for the study was obtained from the Biomedical Research Ethics Committee at the University of KwaZulu-Natal (BE397/13), Boston Children\u2019s Hospital Ethics Review Board (IRB-P00010899), and the University of the Witwatersrand Human Research Ethics Committee (M140426). Additional approvals were obtained from the Provincial Health Research Committee in the KwaZulu-Natal Provincial Department of Health, the eThekwini District Department of Health, and the health facility where the research was conducted.Face-to-face structured interviews using a quantitative questionnaire were conducted by female research assistants in a private space at the clinic. All interviews were conducted in isiZulu. Data were collected and entered by research staff on handheld computer tablet operating Open Data Kit (ODK) Collect. Procedures to promote data quality included skip patterns, range limits and logical checks built into the ODK Collect entry programme, as well as data validation. Participants could choose not to answer questions.Structured questionnaires were used to collect data. Sociodemographic questions included age and education level (including none and post-secondary). HIV-status was based on self-report, with possible responses being: HIV-positive, HIV-negative, refuse to answer, or not known. In the analysis, we recoded refused to answer and not known together as a combined category.Socio-economic status was assessed using a range of measures. Household food insecurity was assessed using the Household Food Insecurity Access Scale (HFIAS) . The HFIFor assets, participants were asked whether households had 15 specific items including a television, hot running water and an electric stove. These items were combined into a scale using Principal Components Analysis of the covariance matrix to create a single score measuring household wealth. This approach is common within economic literature .The primary outcome for this analysis was women\u2019s recent physical and/or sexual IPV victimisation using a scale based on the World Health Organization\u2019s (WHO) violence against women survey and modified for South Africa , 30. PhyDisability was understood as related to functional limitations and assessed using the 12 item WHODAS 2.0 (\u03b1 = 0.81) . The WHOPower in a sexual relationship was measured with fourteen items of the Sexual Relationship Power Scale (SRPS) (\u03b1 = 0.86) . QuestioDepressive symptoms were assessed using the PHQ-9 scale (\u03b1 = 0.75), which has been previously validated in South Africa , 33. NinAnalyses were conducted in STATA/IC14 with individuals as the unit of analysis. Descriptive statistics were first calculated comparing those who had not experienced recent IPV with those who had on all variables. We then undertook unadjusted logistic regression to estimate odds ratios and p-values for each secondary variable.Due to small sample size, in the logistic regression models we entered variables that were significant in the unadjusted analyses at p<0.2. We controlled for age group and educational level. Manual backwards elimination was used to remove variables not making a statistically significant contribution to the model. The backward method is recommended because it is less likely to incur Type II error . We contTo understand intersections between IPV and disability, we built three separate logistic regression models. In model one, we treated WHODAS 2.0 as a continuous reweighted variable  to assesBetween January 2015 and March 2015, women presenting for post-natal care at the clinic were consecutively recruited and screened for eligibility. Of 346 women approached, all agreed to be screened, of whom 310 (89.6%) met study eligibility criteria. Of those eligible, 25 (8.1%) refused to participate in the study citing lack of time. An additional 10, who initially agreed to participate, did not complete the interviews for a variety of reasons including being referred to another clinic during the study visit and thus not completing interviews, and lack of time.In total, 275 mothers were recruited into the study, mean age 26.3 years (95%CI 25.7\u201327.0) . The majPrevalence of past 12-month sexual and/or physical IPV was 10.55% (n = 29). In unadjusted analyses , having Functional limitations/disability were also associated with a greater likelihood of IPV victimisation. With the reweighted WHODAS 2.0 scale, women reporting higher severity of functional limitations reported more IPV victimisation . Women reporting challenges around self-care , mobility challenges , getting along with people , challenges around general life activities  and participation in social activities  all reported increased odds of IPV-victimisation.and depressive symptoms also reported functional limitations, only 1% (n = 2) did not report this. This suggests a high degree of overlap between depressive symptoms and potential disability in this population.To understand the potentially complex relationship between IPV, depressive symptoms, and disability we examined data using two methods. Firstly, our descriptive analysis in the Venn Diagram  highlighIn model 1 , where fIn model 2  functionIn model 3  an interRecent IPV in postpartum women in this sample was relatively high at 10.55%. This is higher than a study by Groves, McNaughton-Reyes  in SouthThere appears to be a complex relationship between IPV and functional limitations/disability. From other research it is known that people with disabilities are substantially more likely to experience violence than people without disabilities . The meaThese results suggest that not all forms of functional limitations have the same risk of increasing women\u2019s experiences of IPV in this sample. In the second model, which focused on categorising women into different forms of functional limitations, only those with mobility limitations experienced higher IPV vulnerability in the final model. As such, it is only women with the specific mobility limitations who experienced greater likelihood of IPV-victimisation. This relationship is likely to be bi-directional, with women who experience IPV having reduced mobility due to physical harm, and women with reduced mobility being more vulnerable to IPV victimisation. This has been seen in other studies, but the direction of causality is unclear . In thisIn model three there was no significant interaction effect between depression and mobility limitations, which may be explained with the small sample size. Despite the lack of interaction effect and, even though we don't yet understand the direction of these associations, our study provides a clear indication that depression and functional limitations should not be considered in isolation, but that the combination of both may create a further risk for IPV. Depression can be associated with certain life experiences that are more common among people with disabilities, who face many unique problems and challenges, which may place them at increased risk for depression .As with other studies, women\u2019s power in sexual relationships was an important factor shaping IPV-vulnerability, whereby those with more power in relationships, experienced less violence in both models. Studies have highlighted the central role of women\u2019s power in relationships as being protective of experiencing IPV , 11, 15.Finally, in both models women reporting higher levels of depressive symptoms had greater likelihood of IPV-victimisation. The relationship between depression and IPV is likely bi-directional with depression as an outcome, and a \u2018cause\u2019, of IPV . For femThe study showed no pregnancy \u2018specific\u2019 factors linked to IPV-victimisation. Other research has highlighted that women who have unintended pregnancies are more likely to experience IPV , althougThis study has several limitations. First, the relatively small sample size and exploratory nature of the analysis meant that associations might have been too small to identify. In addition, as it was a clinic-based sample, it likely under-sampled those with the most severe forms of disability and depression, and cannot be thought of as generalizable to the wider population, although the relationships may still hold true. Finally, as the study is cross-sectional, the directionality of the relationships between IPV, the onset of disability, and depression cannot be established.Few studies have explored the relationship between IPV, depression and disability. This analysis highlights the complex relationship between these issues and raises questions about how to conceptualise and analyse these relationships. First, it showed that while there was a close overlap between depression and disability in the study, they also appeared to be distinct in their relationship to IPV-victimisation. Second, it highlighted that not all forms of disability appeared to place women at risk of IPV-victimisation, but rather it was specific forms of disability, in this case mobility limitations that were associated to women\u2019s vulnerability. As such, research needs to follow women over time to understand the interaction of depression and disability. Analysis also needs to disaggregate effects via disability types to understand when and how different functional limitations may impact on IPV-victimisation.The findings emphasise several important approaches for developing interventions to prevent IPV-victimisation. It is important to recognise that pregnant women are vulnerable to IPV because of wider social factors, rather than pregnancy specific factors alone. Thus, strengthening women\u2019s power in relationships, and working to reduce depressive symptoms, should be an important component of interventions. There is a substantive and growing body of research emphasising the importance of women\u2019s social empowerment  and thesThe study also highlights a strong relationship between certain forms of disability and the risk of IPV-victimisation. Given the lack of effective interventions to reduce IPV amongst women living with disabilities, adapting current evidence-based approaches so that they also include women with more severe disabilities remains a critical challenge to ensure that all women can live free from violence .S1 FigMean for SRPS data for participants with no missing data, and for participants with missing data.(TIF)Click here for additional data file.S1 File(DOCX)Click here for additional data file.S2 FileIndividual level participant data used in analysis.(XLS)Click here for additional data file.", "texts": ["Intimate partner violence (IPV) experienced by pregnant and post-partum women has negative health effects for women, as well as the foetus, and the new-born child. In this study we sought to assess the prevalence and factors associated with recent IPV amongst post-partum women in one clinic in eThekwini Municipality, South Africa, and explore the relationship between IPV, depression and functional limitations/disabilities. Past 12 month IPV-victimisation was 10.55%. Logistic regression modelled relationships between IPV, functional limitations, depressive symptoms, socio-economic measures, and sexual relationship power. In logistic regression models, overall severity of functional limitations were not associated with IPV-victimisation when treated as a continuous overall score. In this model relationship power  and depressive symptoms  were significant. When the different functional limitations were separated out in a second model, significant factors were relationship power , depressive symptoms  and mobility limitations . The study emphasises that not all functional limitations are associated with IPV-experience, that depression and disability while overlapping can also be considered different drivers of vulnerability, and that women\u2019s experience of IPV is not dependent on pregnancy specific factors, but rather wider social factors that all women experience. IPV during pregnancy and in the post-partum period is relatively common globally . The preExperiencing IPV is not only a human rights violation, but also has profound health and social consequences for women . Women wExperiencing IPV during pregnancy and in the post-partum period has not only serious health and social consequences for women, but also negative implications for the developing foetus and the new-born child, such as higher levels of pre-term birth and lower birth weight compared to women not exposed to violence during pregnancy .Research investigating the factors driving women\u2019s experiences of IPV have been linked to gender inequalities, whereby women have less social, economic and political power than men and this social and economic dependency places them at risk of IPV-victimisation , 12. ForWomen may experience additional vulnerabilities to IPV-victimisation during pregnancy. One risk factor is whether the pregnancy was unintended . In addiAlthough depression is a potential consequence of IPV it has also been identified as a risk factor for experiencing IPV . Recent In addition, recent research also suggest a strong association between IPV and disability, a factor that has not been widely investigated in mainstream IPV research. A global systematic review on violence among people with disabilities highlighted that this population are more likely to experience IPV than people without disabilities , 20. ThiAdditionally there may be a complex relationship between disability and depression. Depression is a health condition that can lead to disability through limitations in activities and participation in society . Work amIn this paper, we sought 1) to understand the prevalence and factors associated with IPV amongst post-partum women in one clinic in eThekwini Municipality, South Africa. And 2) to understand the associations between IPV and, depression, and disability in this population amongst women experiencing IPV and those not.This was a cross-sectional study, conducted in one public sector primary healthcare facility serving a large, urban informal settlement in eThekwini Municipality, South Africa. The community is characterized by dense informal dwellings, high levels of poverty, lack of access to formal sanitation and water, and generalized high levels of violence. In addition, 41% of women attending antenatal care in eThekwini Municipality, are estimated to be living with HIV .All participants were aged 18 or older and were biological mothers of infants six weeks old or younger. Women were consecutively recruited from January to March 2015. Within the clinic all women were screened (if they consented) while waiting in a queue to be seen by the health provider. If women agreed and met the eligibility criteria, they were directed to be interviewed by research assistants after their clinic visit. All enrolled participants were given ZAR100 as remuneration for their time and transport. All participants provided written informed consent.Ethical clearance for the study was obtained from the Biomedical Research Ethics Committee at the University of KwaZulu-Natal (BE397/13), Boston Children\u2019s Hospital Ethics Review Board (IRB-P00010899), and the University of the Witwatersrand Human Research Ethics Committee (M140426). Additional approvals were obtained from the Provincial Health Research Committee in the KwaZulu-Natal Provincial Department of Health, the eThekwini District Department of Health, and the health facility where the research was conducted.Face-to-face structured interviews using a quantitative questionnaire were conducted by female research assistants in a private space at the clinic. All interviews were conducted in isiZulu. Data were collected and entered by research staff on handheld computer tablet operating Open Data Kit (ODK) Collect. Procedures to promote data quality included skip patterns, range limits and logical checks built into the ODK Collect entry programme, as well as data validation. Participants could choose not to answer questions.Structured questionnaires were used to collect data. Sociodemographic questions included age and education level (including none and post-secondary). HIV-status was based on self-report, with possible responses being: HIV-positive, HIV-negative, refuse to answer, or not known. In the analysis, we recoded refused to answer and not known together as a combined category.Socio-economic status was assessed using a range of measures. Household food insecurity was assessed using the Household Food Insecurity Access Scale (HFIAS) . The HFIFor assets, participants were asked whether households had 15 specific items including a television, hot running water and an electric stove. These items were combined into a scale using Principal Components Analysis of the covariance matrix to create a single score measuring household wealth. This approach is common within economic literature .The primary outcome for this analysis was women\u2019s recent physical and/or sexual IPV victimisation using a scale based on the World Health Organization\u2019s (WHO) violence against women survey and modified for South Africa , 30. PhyDisability was understood as related to functional limitations and assessed using the 12 item WHODAS 2.0 (\u03b1 = 0.81) . The WHOPower in a sexual relationship was measured with fourteen items of the Sexual Relationship Power Scale (SRPS) (\u03b1 = 0.86) . QuestioDepressive symptoms were assessed using the PHQ-9 scale (\u03b1 = 0.75), which has been previously validated in South Africa , 33. NinAnalyses were conducted in STATA/IC14 with individuals as the unit of analysis. Descriptive statistics were first calculated comparing those who had not experienced recent IPV with those who had on all variables. We then undertook unadjusted logistic regression to estimate odds ratios and p-values for each secondary variable.Due to small sample size, in the logistic regression models we entered variables that were significant in the unadjusted analyses at p<0.2. We controlled for age group and educational level. Manual backwards elimination was used to remove variables not making a statistically significant contribution to the model. The backward method is recommended because it is less likely to incur Type II error . We contTo understand intersections between IPV and disability, we built three separate logistic regression models. In model one, we treated WHODAS 2.0 as a continuous reweighted variable  to assesBetween January 2015 and March 2015, women presenting for post-natal care at the clinic were consecutively recruited and screened for eligibility. Of 346 women approached, all agreed to be screened, of whom 310 (89.6%) met study eligibility criteria. Of those eligible, 25 (8.1%) refused to participate in the study citing lack of time. An additional 10, who initially agreed to participate, did not complete the interviews for a variety of reasons including being referred to another clinic during the study visit and thus not completing interviews, and lack of time.In total, 275 mothers were recruited into the study, mean age 26.3 years (95%CI 25.7\u201327.0) . The majPrevalence of past 12-month sexual and/or physical IPV was 10.55% (n = 29). In unadjusted analyses , having Functional limitations/disability were also associated with a greater likelihood of IPV victimisation. With the reweighted WHODAS 2.0 scale, women reporting higher severity of functional limitations reported more IPV victimisation . Women reporting challenges around self-care , mobility challenges , getting along with people , challenges around general life activities  and participation in social activities  all reported increased odds of IPV-victimisation.and depressive symptoms also reported functional limitations, only 1% (n = 2) did not report this. This suggests a high degree of overlap between depressive symptoms and potential disability in this population.To understand the potentially complex relationship between IPV, depressive symptoms, and disability we examined data using two methods. Firstly, our descriptive analysis in the Venn Diagram  highlighIn model 1 , where fIn model 2  functionIn model 3  an interRecent IPV in postpartum women in this sample was relatively high at 10.55%. This is higher than a study by Groves, McNaughton-Reyes  in SouthThere appears to be a complex relationship between IPV and functional limitations/disability. From other research it is known that people with disabilities are substantially more likely to experience violence than people without disabilities . The meaThese results suggest that not all forms of functional limitations have the same risk of increasing women\u2019s experiences of IPV in this sample. In the second model, which focused on categorising women into different forms of functional limitations, only those with mobility limitations experienced higher IPV vulnerability in the final model. As such, it is only women with the specific mobility limitations who experienced greater likelihood of IPV-victimisation. This relationship is likely to be bi-directional, with women who experience IPV having reduced mobility due to physical harm, and women with reduced mobility being more vulnerable to IPV victimisation. This has been seen in other studies, but the direction of causality is unclear . In thisIn model three there was no significant interaction effect between depression and mobility limitations, which may be explained with the small sample size. Despite the lack of interaction effect and, even though we don't yet understand the direction of these associations, our study provides a clear indication that depression and functional limitations should not be considered in isolation, but that the combination of both may create a further risk for IPV. Depression can be associated with certain life experiences that are more common among people with disabilities, who face many unique problems and challenges, which may place them at increased risk for depression .As with other studies, women\u2019s power in sexual relationships was an important factor shaping IPV-vulnerability, whereby those with more power in relationships, experienced less violence in both models. Studies have highlighted the central role of women\u2019s power in relationships as being protective of experiencing IPV , 11, 15.Finally, in both models women reporting higher levels of depressive symptoms had greater likelihood of IPV-victimisation. The relationship between depression and IPV is likely bi-directional with depression as an outcome, and a \u2018cause\u2019, of IPV . For femThe study showed no pregnancy \u2018specific\u2019 factors linked to IPV-victimisation. Other research has highlighted that women who have unintended pregnancies are more likely to experience IPV , althougThis study has several limitations. First, the relatively small sample size and exploratory nature of the analysis meant that associations might have been too small to identify. In addition, as it was a clinic-based sample, it likely under-sampled those with the most severe forms of disability and depression, and cannot be thought of as generalizable to the wider population, although the relationships may still hold true. Finally, as the study is cross-sectional, the directionality of the relationships between IPV, the onset of disability, and depression cannot be established.Few studies have explored the relationship between IPV, depression and disability. This analysis highlights the complex relationship between these issues and raises questions about how to conceptualise and analyse these relationships. First, it showed that while there was a close overlap between depression and disability in the study, they also appeared to be distinct in their relationship to IPV-victimisation. Second, it highlighted that not all forms of disability appeared to place women at risk of IPV-victimisation, but rather it was specific forms of disability, in this case mobility limitations that were associated to women\u2019s vulnerability. As such, research needs to follow women over time to understand the interaction of depression and disability. Analysis also needs to disaggregate effects via disability types to understand when and how different functional limitations may impact on IPV-victimisation.The findings emphasise several important approaches for developing interventions to prevent IPV-victimisation. It is important to recognise that pregnant women are vulnerable to IPV because of wider social factors, rather than pregnancy specific factors alone. Thus, strengthening women\u2019s power in relationships, and working to reduce depressive symptoms, should be an important component of interventions. There is a substantive and growing body of research emphasising the importance of women\u2019s social empowerment  and thesThe study also highlights a strong relationship between certain forms of disability and the risk of IPV-victimisation. Given the lack of effective interventions to reduce IPV amongst women living with disabilities, adapting current evidence-based approaches so that they also include women with more severe disabilities remains a critical challenge to ensure that all women can live free from violence .S1 FigMean for SRPS data for participants with no missing data, and for participants with missing data.(TIF)Click here for additional data file.S1 File(DOCX)Click here for additional data file.S2 FileIndividual level participant data used in analysis.(XLS)Click here for additional data file."]}
{"representative": "Intimate partner violence (IPV) during pregnancy increases adverse pregnancy outcomes. Knowledge of societal, community, family and individual related factors associated with IPV in pregnancy is limited in Ethiopia. Our study examined these factors in an Ethiopian context.A cross sectional study was conducted among pregnant women attending antenatal care at governmental health institutions, using a consecutive probability sampling strategy. A total of 720 pregnant women were interviewed by five trained nurses or midwives, using a standardized and /pretested survey questionnaire. Bivariate and multivariate logistic regression analyses were applied to assess factors contributing to IPV. We used Akaike\u2019s information criteria, to identify the model that best describes the factors influencing IPV in pregnancy.Among the women interviewed, physical IPV was reported by 35.6%, and lifetime emotional or physical abuse by 81.0%. Perceiving violence as a means to settle interpersonal conflicts, presence of supportive attitudes of wife beating in the society, regarding violence as an expression of masculinity, and presence of strict gender role differences in the society, were all positively associated to IPV in pregnancy. The presence of groups legitimizing men\u2019s violence in the community, feeling isolated, having no social support for victims, and presence of high unemployment, were the perceived community related factors positively associated with IPV in pregnancy.IPV in pregnancy is very prevalent in Ethiopia and is associated with multiple social ecologic factors. Reduction of IPV in pregnancy calls for cross sectorial efforts from stakeholders at different levels. It is important to conceptualize violence as a multifaceted phenomenon grounded in the interplay across societal, community, family, and individual levels. There is a lack of studies that simultaneously examine societal, community, family, and individual related factors contributing to IPV in pregnancy in Africa and in Ethiopia in particular.Intimate partner violence (IPV), is an important global public health and human rights issue, with significant health and socioeconomic development consequences . ViolencA healthy pregnancy is required for favourable maternal and child health outcomes. Pregnancies affected by IPV are reported to have an increased incidence of low maternal weight gain, anaemia, infection, first/second trimester bleeding, late entry into antenatal care (ANC), preterm labour, premature birth and low birth weight baby , 17. HomThis study aimed to address the gaps in the existing literature concerning the social ecologic factors that make pregnant women vulnerable to IPV. Guided by the social ecological model (SEM), the current study examined the prevalence, pattern and the association between social ecologic factors  and IPV in pregnancy in an Ethiopian context.This cross sectional study was conducted during an antenatal care visit at all health centres, and hospitals in Jimma, 177, 900 inhabitants,  and, located in Oromiya regional state, 352 km south west of Addis Ababa, Ethiopia, from November 2015 to March 30, 2016.Included were women, with a pregnancy estimated to be \u2265 24 weeks of gestation. Sample size was calculated based on a single population proportion formula using the assumptions of: 95% confidence interval, 4% degree of precision. We assumed 50% as the expected prevalence based on the average from previous studies  and a 20A standard questionnaire was developed based on the Abuse Assessment Screening (AAS) tools developed by the Nursing Research Consortium on Violence \u201326 and tThe study data were collected by five female, midwives/nurses working at the respective institutions, fluent in both languages (Afan Oromo and Amharic). Training was given on how to interview, handling ethical issues and maintaining confidentiality and privacy using a training manual. During data collection, to prevent incomplete and inconsistent responses, the researcher and supervisors were available for supervising and counter checking completed questionnaires.The experience of Intimate Partner Violence  was measIPV during the current pregnancy was the dependent variable; operationalized in this study as, answering \u2018Yes\u2019 to any of the following: \u201csince you\u2019ve been pregnant (current pregnancy), have you been slapped, kicked, or otherwise physically hurted by your intimate partner \u201d. While, each item under the four domains of social ecologic model  were considered as exposure variables and their responses were coded as Yes/No for each.All information were entered in EPiData and exported to SPSS (version 20.0) for analysis.Multi- collinearity or redundancy, , was cheWe used Akaike\u2019s information criteria (AIC), \u201336 and tWhile adjusting for confounders (age and education of the woman and her partner), we fitted the model of each single factor, with all variables of each domain simultaneously and within the variables under each domain. After analyzing the adjusted OR, and considering the over fitting, under fitting and parsimony , 37, theWhile keeping in mind the AIC, parsimony and under fit criteria of the best model, multivariate logistic regression model was fitted to examine significant variables of the four social ecologic domain factors associated with IPV in pregnancy . The dicEthical clearance from Jimma University College of Health Sciences, IRB (Ref No: HRPGC/305/2015) and the Norwegian Regional Ethical Committee (REK),  was obtInformed written and or / verbal consent was obtained after fully informing participants about the aims and the nature of the study. Respondents were assured about the confidentiality of their response, their voluntarily participation and right to terminate at any time they want. They were also told that their care would not be affected in any way should they decide not to participate in the study.Three hundred and forty four (47.8%) of the 720 participants, mean age SD (24.9\u00b15.0), were between15-24 years and 34.4% were first time pregnant (primi gravida) . Over onIn the current pregnancy, more than one in three women (35.6%) reported experiencing IPV, of which nearly 89% of them had experienced moderate physical violence (severity score of 1\u20133), slapping or pushing being the most frequent incidents (62.1%) and 18% reported being hit on their abdomen (data not shown). The life time prevalence of emotional or physical abuse by partner or someone important was 80.7% and the proportion of violence during pregnancy among ever exposed was 44%. Over half of the women (56.1%) reported physical violence victimization within the last year and the majority of the perpetrators (86.4%) were their husbands. Forced sexual activity was reported by half of the women, but only one woman was offended by a stranger.Being isolated by intimate partner from friends and family was prevalent (40%) and more than half of the women reported fear (53.8%) or psychological abuse (51.4%) in the last one year. During incidents of IPV one in three turned to their family (32.4%) or kept silent (29.5%). The major reasons to keep silent were: not to leave children behind, feeling shame, to honour the tradition that marriage is valued, having no money and nowhere to go, and fear that husband may retaliate or even kill them (data not shown).Using AIC and parsimony criteria of best model as described in the analysis section, the statistical inferences were made based on the traditional null-hypothesis testing  and interpret the result based on it may also lend strength.The subject studied is very sensitive and even stigmatizing; assessment of IPV and its factors based on self-reporting might have introduced systematic errors . Those who were exposed to IPV recently are more likely to report excessively, while those who were exposed a bit long ago may ignore or forget to report, which also might have introduced bias. Bias might have also been introduced due to unmeasured or poorly measured variables, confounders and interactions. The study had a cross sectional design (simultaneous collection of both exposure and outcome variables), and the setting is institutional based, we can neither claim causality nor generalizability, and calls for future prospective longitudinal study.Despite these limitations, this study provides valuable information and contributes to a better understanding of the magnitude of IPV in pregnancy and its multifaceted contributing factors in Ethiopia. The importance of community and societal factors in IPV warrant a public debate about IPV. Male involvement is imperative as impact of male norms related to and childhood experience of IPV are significant contributors to the risk of future IPV, as well as demonstrated in the literature, adverse events like chronic diseases and increased allostatic load . As IPV In conclusion, our study, while maintaining that it is multi-factorial , 40, IPVS1 File(PDF)Click here for additional data file.S2 File(PDF)Click here for additional data file.", "texts": ["Intimate partner violence (IPV) during pregnancy increases adverse pregnancy outcomes. Knowledge of societal, community, family and individual related factors associated with IPV in pregnancy is limited in Ethiopia. Our study examined these factors in an Ethiopian context.A cross sectional study was conducted among pregnant women attending antenatal care at governmental health institutions, using a consecutive probability sampling strategy. A total of 720 pregnant women were interviewed by five trained nurses or midwives, using a standardized and /pretested survey questionnaire. Bivariate and multivariate logistic regression analyses were applied to assess factors contributing to IPV. We used Akaike\u2019s information criteria, to identify the model that best describes the factors influencing IPV in pregnancy.Among the women interviewed, physical IPV was reported by 35.6%, and lifetime emotional or physical abuse by 81.0%. Perceiving violence as a means to settle interpersonal conflicts, presence of supportive attitudes of wife beating in the society, regarding violence as an expression of masculinity, and presence of strict gender role differences in the society, were all positively associated to IPV in pregnancy. The presence of groups legitimizing men\u2019s violence in the community, feeling isolated, having no social support for victims, and presence of high unemployment, were the perceived community related factors positively associated with IPV in pregnancy.IPV in pregnancy is very prevalent in Ethiopia and is associated with multiple social ecologic factors. Reduction of IPV in pregnancy calls for cross sectorial efforts from stakeholders at different levels. It is important to conceptualize violence as a multifaceted phenomenon grounded in the interplay across societal, community, family, and individual levels. There is a lack of studies that simultaneously examine societal, community, family, and individual related factors contributing to IPV in pregnancy in Africa and in Ethiopia in particular.Intimate partner violence (IPV), is an important global public health and human rights issue, with significant health and socioeconomic development consequences . ViolencA healthy pregnancy is required for favourable maternal and child health outcomes. Pregnancies affected by IPV are reported to have an increased incidence of low maternal weight gain, anaemia, infection, first/second trimester bleeding, late entry into antenatal care (ANC), preterm labour, premature birth and low birth weight baby , 17. HomThis study aimed to address the gaps in the existing literature concerning the social ecologic factors that make pregnant women vulnerable to IPV. Guided by the social ecological model (SEM), the current study examined the prevalence, pattern and the association between social ecologic factors  and IPV in pregnancy in an Ethiopian context.This cross sectional study was conducted during an antenatal care visit at all health centres, and hospitals in Jimma, 177, 900 inhabitants,  and, located in Oromiya regional state, 352 km south west of Addis Ababa, Ethiopia, from November 2015 to March 30, 2016.Included were women, with a pregnancy estimated to be \u2265 24 weeks of gestation. Sample size was calculated based on a single population proportion formula using the assumptions of: 95% confidence interval, 4% degree of precision. We assumed 50% as the expected prevalence based on the average from previous studies  and a 20A standard questionnaire was developed based on the Abuse Assessment Screening (AAS) tools developed by the Nursing Research Consortium on Violence \u201326 and tThe study data were collected by five female, midwives/nurses working at the respective institutions, fluent in both languages (Afan Oromo and Amharic). Training was given on how to interview, handling ethical issues and maintaining confidentiality and privacy using a training manual. During data collection, to prevent incomplete and inconsistent responses, the researcher and supervisors were available for supervising and counter checking completed questionnaires.The experience of Intimate Partner Violence  was measIPV during the current pregnancy was the dependent variable; operationalized in this study as, answering \u2018Yes\u2019 to any of the following: \u201csince you\u2019ve been pregnant (current pregnancy), have you been slapped, kicked, or otherwise physically hurted by your intimate partner \u201d. While, each item under the four domains of social ecologic model  were considered as exposure variables and their responses were coded as Yes/No for each.All information were entered in EPiData and exported to SPSS (version 20.0) for analysis.Multi- collinearity or redundancy, , was cheWe used Akaike\u2019s information criteria (AIC), \u201336 and tWhile adjusting for confounders (age and education of the woman and her partner), we fitted the model of each single factor, with all variables of each domain simultaneously and within the variables under each domain. After analyzing the adjusted OR, and considering the over fitting, under fitting and parsimony , 37, theWhile keeping in mind the AIC, parsimony and under fit criteria of the best model, multivariate logistic regression model was fitted to examine significant variables of the four social ecologic domain factors associated with IPV in pregnancy . The dicEthical clearance from Jimma University College of Health Sciences, IRB (Ref No: HRPGC/305/2015) and the Norwegian Regional Ethical Committee (REK),  was obtInformed written and or / verbal consent was obtained after fully informing participants about the aims and the nature of the study. Respondents were assured about the confidentiality of their response, their voluntarily participation and right to terminate at any time they want. They were also told that their care would not be affected in any way should they decide not to participate in the study.Three hundred and forty four (47.8%) of the 720 participants, mean age SD (24.9\u00b15.0), were between15-24 years and 34.4% were first time pregnant (primi gravida) . Over onIn the current pregnancy, more than one in three women (35.6%) reported experiencing IPV, of which nearly 89% of them had experienced moderate physical violence (severity score of 1\u20133), slapping or pushing being the most frequent incidents (62.1%) and 18% reported being hit on their abdomen (data not shown). The life time prevalence of emotional or physical abuse by partner or someone important was 80.7% and the proportion of violence during pregnancy among ever exposed was 44%. Over half of the women (56.1%) reported physical violence victimization within the last year and the majority of the perpetrators (86.4%) were their husbands. Forced sexual activity was reported by half of the women, but only one woman was offended by a stranger.Being isolated by intimate partner from friends and family was prevalent (40%) and more than half of the women reported fear (53.8%) or psychological abuse (51.4%) in the last one year. During incidents of IPV one in three turned to their family (32.4%) or kept silent (29.5%). The major reasons to keep silent were: not to leave children behind, feeling shame, to honour the tradition that marriage is valued, having no money and nowhere to go, and fear that husband may retaliate or even kill them (data not shown).Using AIC and parsimony criteria of best model as described in the analysis section, the statistical inferences were made based on the traditional null-hypothesis testing  and interpret the result based on it may also lend strength.The subject studied is very sensitive and even stigmatizing; assessment of IPV and its factors based on self-reporting might have introduced systematic errors . Those who were exposed to IPV recently are more likely to report excessively, while those who were exposed a bit long ago may ignore or forget to report, which also might have introduced bias. Bias might have also been introduced due to unmeasured or poorly measured variables, confounders and interactions. The study had a cross sectional design (simultaneous collection of both exposure and outcome variables), and the setting is institutional based, we can neither claim causality nor generalizability, and calls for future prospective longitudinal study.Despite these limitations, this study provides valuable information and contributes to a better understanding of the magnitude of IPV in pregnancy and its multifaceted contributing factors in Ethiopia. The importance of community and societal factors in IPV warrant a public debate about IPV. Male involvement is imperative as impact of male norms related to and childhood experience of IPV are significant contributors to the risk of future IPV, as well as demonstrated in the literature, adverse events like chronic diseases and increased allostatic load . As IPV In conclusion, our study, while maintaining that it is multi-factorial , 40, IPVS1 File(PDF)Click here for additional data file.S2 File(PDF)Click here for additional data file."]}
{"representative": "Reducing neonatal mortality is a global priority, and improvements in postnatal health (PNH) practices in India are needed to do so. Intimate partner violence (IPV) may be associated with PNH practices, but little research has assessed this relationship.A cross-sectional analysis of data from a representative household sample of mothers of neonates 0\u201311\u00a0months old in Bihar, India was conducted. The relationship between lifetime IPV experience  and PNH practices  was assessed using multivariate logistic regression.physical violence only (29.0%) had higher odds of skin-to-skin care  and delayed bathing , but lower odds of EIBF  and exclusive breastfeeding . Mothers who had experienced sexual violence only (2.3%) had lower odds of practicing EIBF . Those who had both experiences of physical and sexual violence (14.0%) had increased odds of postpartum modern contraceptive use  and lower odds of delayed bathing .Over 45% of the 10,469 mothers experienced IPV in their lifetime. The three types of IPV experiences differentially related to PNH practices. Adjusted analyses revealed that compared to those who had never experienced IPV, women who experienced The results of this study found differing patterns of vulnerability to poor PNH practices depending on the type of IPV experienced. Efforts to increase access to health services for women experiencing IPV and to integrate IPV intervention into such service may increase PNH practices, and as a result, reduce neonatal mortality. The United Nation\u2019s Sustainable Development Goals highlight neonatal mortality as a priority, setting a target of 12 deaths per 1000 births by 2030, a goal that will require substantial acceleration of progress for many countries . The WorIn Bihar, one of the poorest and most populous Indian states, the neonatal mortality rate is relatively high (32.2 per 1000 live births), with neonatal mortality strongly associated with inadequate PNH practices . A numbeGlobal evidence documents that women who experience IPV are less likely to engage in maternal and child health protective behaviors, including health care seeking, prior to and after pregnancy \u201323. StudImportant in the assessment of IPV as a risk factor for poor PNH practices is consideration of physical and sexual violence separately, as well as their co-occurrence, as a growing body of research suggests different forms of IPV relate to unique patterns of health practices , 33, 34.The current study aims to elucidate the relationship between IPV, specifically when a woman has experienced physical violence only, sexual violence only, or both forms of violence, and PNH practices among a representative sample of mothers of living infants in Bihar, India. Understanding these relationships may help guide the development of new and ongoing interventions to promote neonatal survival.The current study includes analysis of data collected for evaluation of the Ananya program, a partnership initiated in 2012 in Bihar, India, by the Government of Bihar and the Bill and Melinda Gates Foundation designed to increase maternal and child health care utilization in the public health system using a combination of supply-side and demand generation efforts . Ananya A multi-stage sampling approach was used to select villages, randomly selecting first blocks, then villages from those blocks. A listing exercise was conducted in each selected village to identify all women who had a live birth in the previous 12\u00a0months . Details on study sampling and procedures are available in a previous publication by Borkum et al. .n\u2009=\u200910,469); mothers of neonates requiring postnatal medical care were not excluded. Ethical approval for the original evaluation study was provided by India\u2019s Health Ministry Screening Committee. Ethical approval for this analysis was provided by the University of California, San Diego.The survey participation rate was 87% and yielded 11,654 completed surveys from mothers of living children 0\u201311\u00a0months old . Women wThe primary independent variables were lifetime experiences of physical and sexual IPV considered as exclusive categories: no IPV, physical IPV only, sexual IPV only, sexual and physical IPV. Physical IPV was defined as experience of at least one of the following by a husband: being slapped, having an arm twisted or hair pulled, being pushed with his fist, being shaken or having something thrown at you, being kicked, dragged or beaten up, or attempted intentional choking or burning. Sexual IPV was measured by a yes/no response to, \u201cDid your husband ever physically force you to have sexual intercourse with him even when you did not want to?\u201d These measures have been validated in the Multi-country Study on Violence Against Women by the World Health Organization and are routinely included in Demographic and Health Surveys (DHS) .Outcome variables included the following healthy newborn practices: clean cord care (nothing applied to umbilicus after cutting/tying cord); kangaroo mother care (child placed unclothed with skin to skin contact on mother\u2019s chest/abdomen following birth); early initiation of breastfeeding ; delayed bathing (first bath occurred 2 or more days after birth); postnatal care visit by a health worker within 48\u00a0h of birth; and exclusive breastfeeding . Current post-partum contraceptive use was defined as female or male sterilization, or current use of pill, injectable, intrauterine device (IUD), or condom. If contraceptive use was initiated post-partum but discontinued prior to the study, it was not considered current post-partum contraceptive use.Relevant background characteristics were included as covariates: residence in an Ananya program district (yes/no); age of mother ; age of mother at marriage (under 18\u00a0years/over 18\u00a0years old); household wealth index ;  mother\u2019sp\u2009<\u20090.20 levels in bivariate analyses (results not shown). All analyses were adjusted for survey design and individual sampling weights, and were conducted using Stata 13 SE .Descriptive frequencies were calculated for all PNH practice outcomes and covariates, both overall and stratified by IPV experiences. Multivariate logistic regression models were then used to assess the association between IPV and each PNH practice, adjusting for any covariates that were significant at More than 40% of the 10,469 mothers reported ever experiencing physical IPV by their husband  and more than one in six mothers reported ever experiencing sexual violence from their husband  (Table\u00a0The majority of participants (78.2%) were between the ages of 20\u201329 and more than two-thirds had at least two children Table . Nearly Experiencing physical IPV only was disproportionately prevalent among mothers who practiced skin-to-skin care (42.1% vs. 32.2% no IPV), were age 30+ (21.5% vs. 15% no IPV), were under age 18 when they married (52.6% vs. 39.4% of those experiencing no IPV), in the lowest wealth quartile (34.4% vs. 25.8% no IPV), had no education (62.0% vs. 47.6% no IPV), had a spouse with no education (39.5% vs. 28.5% no IPV), were from SC/ST caste (33.2% vs. 21.0% no IPV), had three or more children (46.5% vs. 36.8% no IPV), received fewer than 4 ANC visits (85.5% vs. 78.2% no IPV), did not have a skilled birth attendant (32.6% vs. 24.9% no IPV) and received a postnatal visit to discuss family planning (15.7% vs. 9.8% no IPV)  and delayed bathing , but lower odds of EIBF , and exclusive breastfeeding   and women experiencing both physical and sexual IPV were twice as likely to be using condoms   were using male or female sterilization, 31 (2.4%) oral contraception (pills), 62 (4.9%) condoms, and 11 (0.9%) other methods for preventing pregnancy. A multinomial regression assessing the association between IPV and method-specific current contraceptive use found that, relative to women who had not experienced IPV, women experiencing physical IPV only were less likely to be using oral contraception  conducted in 2015/16 found a similar rate of spousal violence among ever-married women in Bihar (43.2%) . Sexual Intimate partner violence was negatively associated with healthy breastfeeding practices. The odds of early initiation of breastfeeding were decreased by between 19% and 48% among women who experienced physical or sexual IPV, respectively. This pattern is consistent with earlier studies of the association of types of IPV and breastfeeding , 40, 41.Odds of exclusive breastfeeding for 6 months were 17% lower among women reporting physical IPV only. Uniform with earlier studies, these results could possibly indicate limited autonomy of mothers to make breastfeeding decisions, lower confidence to be able to breastfeed, or resistance to the intimate personal contact involved in breastfeeding\u00a0related to\u00a0trauma , 40\u201344.A novel finding from this study is that women who reported only physical violence\u00a0were more likely to enact certain PNH practices, including skin-to-skin care and delayed bathing. A possible explanation for this relationship may be that, while experiencing physical IPV may force a woman to compromise her own health and self-care, she may work even harder than her peers to provide adequate care for her infant as a way of compensating for any disruptions her husband\u2019s IPV may be causing within the family . In contLikelihood of postpartum contraception also differed across IPV experiences. Women who reported experiencing only physical IPV had 18% lower odds of postpartum contraception, while women reporting both sexual and physical IPV had a 35% increased odds of postpartum contraception. Significantly lower postpartum oral contraception use among women experiencing physical IPV only and significantly higher postpartum condom use among women experiencing physical and sexual IPV was observed. These findings were unexpected in light of prior research conducted with representative samples in India. These method-specific results differed from prior findings from national data of married women in India that found lower condom but higher oral contraception usage among women experiencing sexual violence . Raj et Sociodemographic characteristics were also found to relate to beneficial PNH behaviors. Being age 18 or older when married and at the time of survey, and having had a child prior to the index child were all positively associated with PNH behaviors, particularly those related to breastfeeding. Higher wealth was associated with increased odds of applying nothing to the umbilicus after cutting/tying the cord, skin-to-skin care, and current post-partum contraceptive. An unexpected trend, however, was that as spousal education increased, adherence to clean cord care was less likely. More research is needed to understand this association, as spousal education may be a marker for a particular set of husband-related characteristics that are associated with a lack of support for this PNH practice or behaviors related to neonatal care that counteract these beneficial PNH practices.Exposure to health services, including ANC, SBA, and CHW visits during the last trimester of pregnancy, emerged as experiences largely beneficial to enactment of PNH practices, even in models adjusted for IPV and other intervention services. However, SBA and four or more ANC were less likely among women experiencing physical IPV. Efforts to ensure that women who are experiencing IPV are able to access health services are needed. Women living in an Ananya program district, a program that aims to increase access to and quality of maternal and child health services, had higher odds of all assessed PNH practices, except for postnatal care, regardless of IPV exposure. Postnatal care within 48\u00a0h of childbirth, though, was not reduced among women exposed to IPV. This finding suggests that beyond being of benefit for neonates of all women, postnatal health services may be an important \u201ctouch-point\u201d for victims of IPV, particularly in the past year. Programs like Ananya, and health services such as postnatal care, may offer a potentially important opportunity to provide support and intervene with households to help reduce or mitigate their exposure to IPV and related health vulnerabilities for both new mothers and their neonates . The AnaConsideration of the limitations of this study is important for interpreting results. Data analyzed in this study are the second cross-section of women who have recently given birth from an evaluation of a large-scale effort to improve health services, and results demonstrate a positive effect on PNH practices for those residing in the intervention districts. To address potential intervention effects on the currently assessed associations, all multivariate analyses were adjusted for exposure to this intervention. Additionally, unobserved confounding factors not accounted for may obscure true effects, though models were adjusted for a variety of highly relevant covariates in order to limit this potential. While reports of past 12\u00a0month IPV experiences likely temporarily predicate or overlap with the postnatal period in which PNH practices may have occurred, these results only provide indication of correlation and do not indicate causal relationships. One important limitation of these data is that they rely on participant self-report of PNH practices and IPV experiences from up to 11\u00a0months post-partum. This relatively long time gap may leave data vulnerable to recall and desirability bias, which could influence results to be biased either toward or away from the null hypothesis. Additionally, this analysis of a dichotomous measure of IPV experience does not provide any information on how frequency of IPV could change the association between IPV and PNH practices. The results of this study are representative of recent mothers in the state of Bihar, and cannot be generalized to other populations or regions of India or elsewhere.The current study found a high prevalence of IPV, including recent IPV, among this representative sample of recent mothers. Results indicate different patterns of vulnerability to poor PNH practices depending on the type of IPV experienced, whether physical only, sexual only, or both forms. Overall, IPV was found to be largely associated with poor PNH practices, most clearly demonstrated in its effects on breast feeding. However, a smaller subset of beneficial PNH practices were more likely among women based on the type of IPV experienced. Physical violence alone appeared to be associated with mothers\u2019, perhaps, greater efforts to ensure care for their neonate, whereas experiences of both physical and sexual IPV, or of only sexual IPV, appeared to significantly inhibit healthy PNH practices. More research is needed to further clarify the observed associations and mechanisms behind these.The pattern of IPV experience and postpartum contraception use is unclear. The overall association between IPV and contraception use mirrored findings from other studies, but the type-specific analyses of postpartum contraception use suggests a potentially changing dynamic for the association between contraception type and type of IPV experience or a unique dynamic for postpartum contraception use.Opportunity for mitigating the negative impact of IPV on PNH behaviors may exist within health care encounters, particularly within postnatal care. Current governmental efforts to increase access and quality of maternal and neonatal health services may also facilitate women experiencing IPV to engage with PNH practices, and as a result, reduce neonatal mortality. Moreover, postnatal health care visits may provide an important opportunity for providing IPV support to victims, which could be built into existing governmental efforts to strengthen quality of care, to reduce IPV and its impact on maternal and neonatal health.", "texts": ["Reducing neonatal mortality is a global priority, and improvements in postnatal health (PNH) practices in India are needed to do so. Intimate partner violence (IPV) may be associated with PNH practices, but little research has assessed this relationship.A cross-sectional analysis of data from a representative household sample of mothers of neonates 0\u201311\u00a0months old in Bihar, India was conducted. The relationship between lifetime IPV experience  and PNH practices  was assessed using multivariate logistic regression.physical violence only (29.0%) had higher odds of skin-to-skin care  and delayed bathing , but lower odds of EIBF  and exclusive breastfeeding . Mothers who had experienced sexual violence only (2.3%) had lower odds of practicing EIBF . Those who had both experiences of physical and sexual violence (14.0%) had increased odds of postpartum modern contraceptive use  and lower odds of delayed bathing .Over 45% of the 10,469 mothers experienced IPV in their lifetime. The three types of IPV experiences differentially related to PNH practices. Adjusted analyses revealed that compared to those who had never experienced IPV, women who experienced The results of this study found differing patterns of vulnerability to poor PNH practices depending on the type of IPV experienced. Efforts to increase access to health services for women experiencing IPV and to integrate IPV intervention into such service may increase PNH practices, and as a result, reduce neonatal mortality. The United Nation\u2019s Sustainable Development Goals highlight neonatal mortality as a priority, setting a target of 12 deaths per 1000 births by 2030, a goal that will require substantial acceleration of progress for many countries . The WorIn Bihar, one of the poorest and most populous Indian states, the neonatal mortality rate is relatively high (32.2 per 1000 live births), with neonatal mortality strongly associated with inadequate PNH practices . A numbeGlobal evidence documents that women who experience IPV are less likely to engage in maternal and child health protective behaviors, including health care seeking, prior to and after pregnancy \u201323. StudImportant in the assessment of IPV as a risk factor for poor PNH practices is consideration of physical and sexual violence separately, as well as their co-occurrence, as a growing body of research suggests different forms of IPV relate to unique patterns of health practices , 33, 34.The current study aims to elucidate the relationship between IPV, specifically when a woman has experienced physical violence only, sexual violence only, or both forms of violence, and PNH practices among a representative sample of mothers of living infants in Bihar, India. Understanding these relationships may help guide the development of new and ongoing interventions to promote neonatal survival.The current study includes analysis of data collected for evaluation of the Ananya program, a partnership initiated in 2012 in Bihar, India, by the Government of Bihar and the Bill and Melinda Gates Foundation designed to increase maternal and child health care utilization in the public health system using a combination of supply-side and demand generation efforts . Ananya A multi-stage sampling approach was used to select villages, randomly selecting first blocks, then villages from those blocks. A listing exercise was conducted in each selected village to identify all women who had a live birth in the previous 12\u00a0months . Details on study sampling and procedures are available in a previous publication by Borkum et al. .n\u2009=\u200910,469); mothers of neonates requiring postnatal medical care were not excluded. Ethical approval for the original evaluation study was provided by India\u2019s Health Ministry Screening Committee. Ethical approval for this analysis was provided by the University of California, San Diego.The survey participation rate was 87% and yielded 11,654 completed surveys from mothers of living children 0\u201311\u00a0months old . Women wThe primary independent variables were lifetime experiences of physical and sexual IPV considered as exclusive categories: no IPV, physical IPV only, sexual IPV only, sexual and physical IPV. Physical IPV was defined as experience of at least one of the following by a husband: being slapped, having an arm twisted or hair pulled, being pushed with his fist, being shaken or having something thrown at you, being kicked, dragged or beaten up, or attempted intentional choking or burning. Sexual IPV was measured by a yes/no response to, \u201cDid your husband ever physically force you to have sexual intercourse with him even when you did not want to?\u201d These measures have been validated in the Multi-country Study on Violence Against Women by the World Health Organization and are routinely included in Demographic and Health Surveys (DHS) .Outcome variables included the following healthy newborn practices: clean cord care (nothing applied to umbilicus after cutting/tying cord); kangaroo mother care (child placed unclothed with skin to skin contact on mother\u2019s chest/abdomen following birth); early initiation of breastfeeding ; delayed bathing (first bath occurred 2 or more days after birth); postnatal care visit by a health worker within 48\u00a0h of birth; and exclusive breastfeeding . Current post-partum contraceptive use was defined as female or male sterilization, or current use of pill, injectable, intrauterine device (IUD), or condom. If contraceptive use was initiated post-partum but discontinued prior to the study, it was not considered current post-partum contraceptive use.Relevant background characteristics were included as covariates: residence in an Ananya program district (yes/no); age of mother ; age of mother at marriage (under 18\u00a0years/over 18\u00a0years old); household wealth index ;  mother\u2019sp\u2009<\u20090.20 levels in bivariate analyses (results not shown). All analyses were adjusted for survey design and individual sampling weights, and were conducted using Stata 13 SE .Descriptive frequencies were calculated for all PNH practice outcomes and covariates, both overall and stratified by IPV experiences. Multivariate logistic regression models were then used to assess the association between IPV and each PNH practice, adjusting for any covariates that were significant at More than 40% of the 10,469 mothers reported ever experiencing physical IPV by their husband  and more than one in six mothers reported ever experiencing sexual violence from their husband  (Table\u00a0The majority of participants (78.2%) were between the ages of 20\u201329 and more than two-thirds had at least two children Table . Nearly Experiencing physical IPV only was disproportionately prevalent among mothers who practiced skin-to-skin care (42.1% vs. 32.2% no IPV), were age 30+ (21.5% vs. 15% no IPV), were under age 18 when they married (52.6% vs. 39.4% of those experiencing no IPV), in the lowest wealth quartile (34.4% vs. 25.8% no IPV), had no education (62.0% vs. 47.6% no IPV), had a spouse with no education (39.5% vs. 28.5% no IPV), were from SC/ST caste (33.2% vs. 21.0% no IPV), had three or more children (46.5% vs. 36.8% no IPV), received fewer than 4 ANC visits (85.5% vs. 78.2% no IPV), did not have a skilled birth attendant (32.6% vs. 24.9% no IPV) and received a postnatal visit to discuss family planning (15.7% vs. 9.8% no IPV)  and delayed bathing , but lower odds of EIBF , and exclusive breastfeeding   and women experiencing both physical and sexual IPV were twice as likely to be using condoms   were using male or female sterilization, 31 (2.4%) oral contraception (pills), 62 (4.9%) condoms, and 11 (0.9%) other methods for preventing pregnancy. A multinomial regression assessing the association between IPV and method-specific current contraceptive use found that, relative to women who had not experienced IPV, women experiencing physical IPV only were less likely to be using oral contraception  conducted in 2015/16 found a similar rate of spousal violence among ever-married women in Bihar (43.2%) . Sexual Intimate partner violence was negatively associated with healthy breastfeeding practices. The odds of early initiation of breastfeeding were decreased by between 19% and 48% among women who experienced physical or sexual IPV, respectively. This pattern is consistent with earlier studies of the association of types of IPV and breastfeeding , 40, 41.Odds of exclusive breastfeeding for 6 months were 17% lower among women reporting physical IPV only. Uniform with earlier studies, these results could possibly indicate limited autonomy of mothers to make breastfeeding decisions, lower confidence to be able to breastfeed, or resistance to the intimate personal contact involved in breastfeeding\u00a0related to\u00a0trauma , 40\u201344.A novel finding from this study is that women who reported only physical violence\u00a0were more likely to enact certain PNH practices, including skin-to-skin care and delayed bathing. A possible explanation for this relationship may be that, while experiencing physical IPV may force a woman to compromise her own health and self-care, she may work even harder than her peers to provide adequate care for her infant as a way of compensating for any disruptions her husband\u2019s IPV may be causing within the family . In contLikelihood of postpartum contraception also differed across IPV experiences. Women who reported experiencing only physical IPV had 18% lower odds of postpartum contraception, while women reporting both sexual and physical IPV had a 35% increased odds of postpartum contraception. Significantly lower postpartum oral contraception use among women experiencing physical IPV only and significantly higher postpartum condom use among women experiencing physical and sexual IPV was observed. These findings were unexpected in light of prior research conducted with representative samples in India. These method-specific results differed from prior findings from national data of married women in India that found lower condom but higher oral contraception usage among women experiencing sexual violence . Raj et Sociodemographic characteristics were also found to relate to beneficial PNH behaviors. Being age 18 or older when married and at the time of survey, and having had a child prior to the index child were all positively associated with PNH behaviors, particularly those related to breastfeeding. Higher wealth was associated with increased odds of applying nothing to the umbilicus after cutting/tying the cord, skin-to-skin care, and current post-partum contraceptive. An unexpected trend, however, was that as spousal education increased, adherence to clean cord care was less likely. More research is needed to understand this association, as spousal education may be a marker for a particular set of husband-related characteristics that are associated with a lack of support for this PNH practice or behaviors related to neonatal care that counteract these beneficial PNH practices.Exposure to health services, including ANC, SBA, and CHW visits during the last trimester of pregnancy, emerged as experiences largely beneficial to enactment of PNH practices, even in models adjusted for IPV and other intervention services. However, SBA and four or more ANC were less likely among women experiencing physical IPV. Efforts to ensure that women who are experiencing IPV are able to access health services are needed. Women living in an Ananya program district, a program that aims to increase access to and quality of maternal and child health services, had higher odds of all assessed PNH practices, except for postnatal care, regardless of IPV exposure. Postnatal care within 48\u00a0h of childbirth, though, was not reduced among women exposed to IPV. This finding suggests that beyond being of benefit for neonates of all women, postnatal health services may be an important \u201ctouch-point\u201d for victims of IPV, particularly in the past year. Programs like Ananya, and health services such as postnatal care, may offer a potentially important opportunity to provide support and intervene with households to help reduce or mitigate their exposure to IPV and related health vulnerabilities for both new mothers and their neonates . The AnaConsideration of the limitations of this study is important for interpreting results. Data analyzed in this study are the second cross-section of women who have recently given birth from an evaluation of a large-scale effort to improve health services, and results demonstrate a positive effect on PNH practices for those residing in the intervention districts. To address potential intervention effects on the currently assessed associations, all multivariate analyses were adjusted for exposure to this intervention. Additionally, unobserved confounding factors not accounted for may obscure true effects, though models were adjusted for a variety of highly relevant covariates in order to limit this potential. While reports of past 12\u00a0month IPV experiences likely temporarily predicate or overlap with the postnatal period in which PNH practices may have occurred, these results only provide indication of correlation and do not indicate causal relationships. One important limitation of these data is that they rely on participant self-report of PNH practices and IPV experiences from up to 11\u00a0months post-partum. This relatively long time gap may leave data vulnerable to recall and desirability bias, which could influence results to be biased either toward or away from the null hypothesis. Additionally, this analysis of a dichotomous measure of IPV experience does not provide any information on how frequency of IPV could change the association between IPV and PNH practices. The results of this study are representative of recent mothers in the state of Bihar, and cannot be generalized to other populations or regions of India or elsewhere.The current study found a high prevalence of IPV, including recent IPV, among this representative sample of recent mothers. Results indicate different patterns of vulnerability to poor PNH practices depending on the type of IPV experienced, whether physical only, sexual only, or both forms. Overall, IPV was found to be largely associated with poor PNH practices, most clearly demonstrated in its effects on breast feeding. However, a smaller subset of beneficial PNH practices were more likely among women based on the type of IPV experienced. Physical violence alone appeared to be associated with mothers\u2019, perhaps, greater efforts to ensure care for their neonate, whereas experiences of both physical and sexual IPV, or of only sexual IPV, appeared to significantly inhibit healthy PNH practices. More research is needed to further clarify the observed associations and mechanisms behind these.The pattern of IPV experience and postpartum contraception use is unclear. The overall association between IPV and contraception use mirrored findings from other studies, but the type-specific analyses of postpartum contraception use suggests a potentially changing dynamic for the association between contraception type and type of IPV experience or a unique dynamic for postpartum contraception use.Opportunity for mitigating the negative impact of IPV on PNH behaviors may exist within health care encounters, particularly within postnatal care. Current governmental efforts to increase access and quality of maternal and neonatal health services may also facilitate women experiencing IPV to engage with PNH practices, and as a result, reduce neonatal mortality. Moreover, postnatal health care visits may provide an important opportunity for providing IPV support to victims, which could be built into existing governmental efforts to strengthen quality of care, to reduce IPV and its impact on maternal and neonatal health."]}
{"representative": "The fundamental requirement for the autonomous capsule-based self-healing process to work is that cracks need to reach the capsules and break them such that the healing agent can be released. Ignoring all other aspects, the amount of healing agents released into the crack is essential to obtain a good healing. Meanwhile, from the perspective of the capsule shapes, spherical or elongated capsules (hollow tubes/fibres) are the main morphologies used in capsule-based self-healing materials. The focus of this contribution is the description of the effects of capsule shape on the efficiency of healing agent released in capsule-based self-healing material within the framework of the theory of geometrical probability and integral geometry. Analytical models are developed to characterize the amount of healing agent released per crack area from capsules for an arbitrary crack intersecting with capsules of various shapes in a virtual capsule-based self-healing material. The average crack opening distance is chosen to be a key parameter in defining the healing potential of individual cracks in the models. Furthermore, the accuracy of the developed models was verified by comparison to the data from a published numerical simulation study. The initiation and propagation of damages/cracks at different length scales frequently result in structural degradation in materials. In structural materials, even micro-damage can lead to degradation in stiffness and durability and sometimes also to spontaneous loss of structural integrity. Furthermore, internal micro-damage is difficult to detect, repair cost of the damaged structural part is usually large and in some cases repair is impossible due to inaccessibility . In the meantime, the demand for continual improvement of engineering material performance is a common feature of many modern engineering projects and autonomous reliable repair of the internal micro-damage/cracks is desirable. To extend the structural lifetime and save maintenance costs, a fantastic strategy that once a crack or damage occurs the designed material possesses the ability to heal (recover/repair) the internal damages automatically by initiating some form of repair mechanism without any external intervention was put forward, i.e. self-healing , 2. GeneSelf-healing of fracture surfaces in polymer composites with an encapsulated healing agent has rapidly developed over the past decade , 15\u201319. Much progresses that a crack hits the embedded spherical/elongated capsules has been made by modeling methods and numerical simulation , 25\u201328. Ignoring all other aspects, the amount of healing agents released into the crack is essential to obtain a good healing. To enhance the release of healing agent per crack area, the introduction of elongated liquid filled capsules was recommended . By an eThe focus of this contribution is the description of the effects of capsule shape on the healing efficiency of healing agent released to crack surface in capsule-based self-healing materials within the framework of the theory of geometrical probability and integral geometry. Employing these tools, analytical expressions are developed to characterize the healing efficiency attributed for various shapes of capsules. The model stresses the crack opening distance, rather than the crack length, as a key parameter to characterize the healing potential of individual cracks. Furthermore, the accuracy of the developed analytical model was verified by comparison of its results with those of the published numerical simulation studies.The fracture surface of epoxy resin containing randomly dispersed spherical polymer particles or chopped glass fibres was experimentally examined to predict the self-healing efficiency of capsules by scanning electron microscopy (SEM) . In the Usually, the typical concentration of capsules mixed in self-healing material matrix is relatively low, such as in polymer composites , 35. In r uniformly distributed in the cubic sample T of side a (i.e. a representative volume element (RVE) satisfying r<<a) and VV denotes the volume fraction of capsules inside the sample. The capsule-based self-healing virtual material is considered to be a homogeneous matrix.As shown in n, hit by a random sectioning plane with area AT in the sample isV0 is the single capsule volume and N is the total amount of spherical capsules present inside the sampling region. So, the volume of healing agent released on the per area of crack is given byVRVE = a3, it obtainsAs it is deduced in the Appendix A, the probability that a spherical capsule in the cubic sample hit by a random sectioning planar crack is given by Eq . Then, ted by Eq . From EqVV\u22c5VRVEV0in whichX=n\u22c5V0ATAlternatf (f<1) which characterizes the discount is necessary and well-defined. Namely, when a capsule is fractured upon intersection by a crack, a part of the healing agent with volume fraction fV0 is released and flows in the crack. So, repeating the above process the volume of healing agent released on the per area of crack becomesIn practice, it is unlikely for a ruptured capsule to fully release its content. The volume of healing agent to be released may be discounted because of the effect of the size and the shell materials of capsule and the viscosity of healing agent, etc. Consequently, the dosage of healing agent to be released should be discounted. Hence, a factor h and radius r uniformly distributed in the cubic sample T of side a (i.e. a representative volume element (RVE) satisfying h, r << a) and VV denotes the volume fraction of capsules inside the sample. The capsule-based self-healing virtual material is considered to be a homogeneous matrix. As it is deduced in the Appendix A, the probability that a spherocylinder in the cubic sample hit by a random sectioning planar crack can be expressed by Eq . Then Eq  which characterizes the discount is interesting.For the case of spherocylindrical capsule, a similar discussion can be conducted when only a fraction of the capsule content is released from the embedded capsules as was done for the spherical capsules. Namely, a factor When spherical capsules are employed in the self-healing system, the analytical expression Eq  of self-V0 = 15.7 \u03bcm3 (i.e. a capsule diameter 2r = 3.11 \u03bcm) and volume fraction VV = 0.10, an average volume per area is found of X = 0.3107 \u03bcm3/\u03bcm2 via the presented formula Eq (3/\u03bcm2. V0)1/3, for a given volume fraction VV, can simply be derived from Eq 1/3 = 0.81, 1.61, 2.51, 3.22, 5.01, 6.31 \u03bcm, it can be drawn the line graph of X via (V0)1/3 according to Eq 1/3 is consistent with the trend as demonstrated in Eq 1/3\u22c5VVAs shownstigated  23]. It. ItV0 = 4\u03c0)1/3\u22c5VVAs shownV0 = 15.7 \u03bcm3 and an aspect ratio \u03c4 = 5 (i.e. h = 8r) and volume fraction 0.10, an average volume per area is found of Y = 0.487 \u03bcm3/\u03bcm2 via formula Eq 1/3, for a given volume fraction VV, can easily be derived by Eq 1/3 = 1.69, 2.49, 3.21, 5.00, 6.31 \u03bcm, graph of Y with respect to (V0)1/3 on the basis of Eq 1/3 is consistent with the trend as demonstrated in Eq 1/3 for different capsule concentrations and aspect ratio at random capsule orientation can be obtained. From the analytical expression Y, i.e. Eqs (Y/ (V0)1/3 is a function of the aspect ratio \u03c4 and volume fraction VV. Both the curve Y/ (V0)1/3 and the numerical values (Y/ (V0)1/3 and \u03c4. From Y/ (V0)1/3 is improved increases as the aspect ratio increases for a given healing capacity of a single capsule. When the volume fraction and aspect ratio of embedded sphereocylindical capsules gets bigger, the deviations bewteen theoretical results and simulated values of Y/ (V0)1/3 also grows. The deviations may be originated from the ignoring of the overlapping among the embedded capsules, especially as the aspect ratio and the content are both increasing. Furthermore, for real materials containing elongated particles at a higher volume fraction (e.g. VV>0.1) alignment of the particles is almost unavoidable and isotropic distributions are unrealistic.Also, the relationship between the efficiency and the aspect ratio can be investigated from Eq . Here, Yi.e. Eqs  and 10)Y/ (V0)1/l values  given byY/X which represents the ratio of the volume of healing agent to be released on the per area of crack can be obtained from Eqs Y/X whichY/X is an analytical formula that characterizes the quotient of the determined slopes for spherocylindrical and spherical capsules at a fixed total capsule volume fraction. If the volume fraction of two types of capsules are equal and the size of spherical capsules with fixed volume which will be embedded in the matrix is given, the efficiency of healing agent released from spherocylindrical capsules employed in self-healing system increases as the aspect ratio or the volume of the type of spherocylindrical capsule grows as shown in \u03c3 = 0.2, 0.5, 1  embedded. Just when \u03c3 = 1 and \u03c4 = 1, the efficiencies are equal for the two types of capsules. Therefore, both shape and size of capsules should be jointly investigated to improve the efficiency of healing agent released in capsule-based self-healing composite materials. This point is opposed with the claim [RIF is a function of the capsule aspect ratio only and is independent of the volume fraction and the capsule volume\u2019.Actually, he claim  that \u2018foIn this contribution the effects of capsule shape on the efficiency of healing agent to be released in capsule-based self-healing composite materials are conducted. When capsules are randomly distributed in the matrix and a crack occurs and grows, the analytical expression of efficiency of healing agent released by spherical or spherocylindrical capsules are stemmed from a mathematically rigorous reasoning via the theory of geometrical probability and integral geometry. The crack opening distance is chosen to characterize the healing potential of individual cracks in the models. Furthermore, the reliabilities of the developed models can be verified by data from relevant literature information, which was implemented via numerical simulation. It was found that both shape and size of capsules should be jointly investigated to improve the efficiency of healing agent to be released in capsule-based self-healing composite materials. This point is opposed with the existing claim. As a result of the model, the volume fraction of capsules required to be embedded in matrix can be determined via the developed efficiency model for different type of shaped capsules. The results of the analytical models will serve to understand the probability of crack intersection with capsules and guide the further development of spherical or elongated liquid filled capsules in capsule-based self-healing composite materials.The probability that a randomly chosen crack plane meets the capsule could be obtained by the theory of Integral Geometry as follows.K0, K1 be convex sets in En such that K1 \u2282 K0. The probability that a randomly chosen r-plane Lr  that meets K0 also meets K1 isMr(\u2202K) = nWr+1(K) , and n is the dimension of space. Wr+1(K) is often called quermassintegrale or mean cross-sectional measures of a convex set K introduced by Minkowski, while Mr(\u2202K) is the integrals of mean curvature of the boundary \u2202K of a convex set K [n = 3, r = 2, it becomesLet ex set K . For n =K1 with a capsule, a K0 with a sampling region . For a spherical capsule K1 with radius r, it holds [K0 with edge a, it hasK0 also meets the capsule K1 isIn the capsule-based self-healing model material it equates a convex body it holds W2(K1)=(=(4\u03c0r)/3,For the 2(K0)=\u03c0a,Hence, fParallel convex sets in the theory of Integral Geometry is employed. Parallel convex sets: The parallel body K\u03c1 in the distance \u03c1 of a convex set K is the union of all solid spheres of radius \u03c1 the centers of which are points of K. The boundary \u2202K\u03c1 is called the parallel surface of \u2202K in the distance \u03c1. It is worth noting that the integral of mean curvature of the boundary \u2202K\u03c1 can be expressed by the function of the integral of mean curvature of the boundary \u2202K [Kr in the distance r of a segment set K with length h is the union of all solid spheres of radius r the centers of which are points of K. From Eq ,1,\u2026,n\u22121.So, a spE3, when K reduces to a line segment of length h, the mean curvature integrals satisfies M1(\u2202K) = \u03c0h, M2(\u2202K) = 4\u03c0. So, the mean curvature integrals of a spherocylindrical capsule isFor the ordinary space K0 also meets the capsule K1 isNamely,from Eqs  and  are M0 = area of the boundary K; M1 = integral of mean curvature of the boundary K. Then, the integrals of mean curvature can be expressed as follows [\u0394 is the breadth of K in the direction u2, that is, the distance between the two support planes of K that are perpendicular to u2 and that contain K between them. The breadth of K is also called as the mean caliper diameter in the terminology of stereology [M1 is equal, up to the factor 2\u03c0, to the mean distance between parallel support planes.For a convex body  follows M1=12\u222bU2ereology . Thus we[\u0394=M1/2\u03c0.It folloS1 Excel(XLS)Click here for additional data file.S2 Excel(XLS)Click here for additional data file.S3 Excel(XLS)Click here for additional data file.S4 Excel(XLS)Click here for additional data file.", "texts": ["The fundamental requirement for the autonomous capsule-based self-healing process to work is that cracks need to reach the capsules and break them such that the healing agent can be released. Ignoring all other aspects, the amount of healing agents released into the crack is essential to obtain a good healing. Meanwhile, from the perspective of the capsule shapes, spherical or elongated capsules (hollow tubes/fibres) are the main morphologies used in capsule-based self-healing materials. The focus of this contribution is the description of the effects of capsule shape on the efficiency of healing agent released in capsule-based self-healing material within the framework of the theory of geometrical probability and integral geometry. Analytical models are developed to characterize the amount of healing agent released per crack area from capsules for an arbitrary crack intersecting with capsules of various shapes in a virtual capsule-based self-healing material. The average crack opening distance is chosen to be a key parameter in defining the healing potential of individual cracks in the models. Furthermore, the accuracy of the developed models was verified by comparison to the data from a published numerical simulation study. The initiation and propagation of damages/cracks at different length scales frequently result in structural degradation in materials. In structural materials, even micro-damage can lead to degradation in stiffness and durability and sometimes also to spontaneous loss of structural integrity. Furthermore, internal micro-damage is difficult to detect, repair cost of the damaged structural part is usually large and in some cases repair is impossible due to inaccessibility . In the meantime, the demand for continual improvement of engineering material performance is a common feature of many modern engineering projects and autonomous reliable repair of the internal micro-damage/cracks is desirable. To extend the structural lifetime and save maintenance costs, a fantastic strategy that once a crack or damage occurs the designed material possesses the ability to heal (recover/repair) the internal damages automatically by initiating some form of repair mechanism without any external intervention was put forward, i.e. self-healing , 2. GeneSelf-healing of fracture surfaces in polymer composites with an encapsulated healing agent has rapidly developed over the past decade , 15\u201319. Much progresses that a crack hits the embedded spherical/elongated capsules has been made by modeling methods and numerical simulation , 25\u201328. Ignoring all other aspects, the amount of healing agents released into the crack is essential to obtain a good healing. To enhance the release of healing agent per crack area, the introduction of elongated liquid filled capsules was recommended . By an eThe focus of this contribution is the description of the effects of capsule shape on the healing efficiency of healing agent released to crack surface in capsule-based self-healing materials within the framework of the theory of geometrical probability and integral geometry. Employing these tools, analytical expressions are developed to characterize the healing efficiency attributed for various shapes of capsules. The model stresses the crack opening distance, rather than the crack length, as a key parameter to characterize the healing potential of individual cracks. Furthermore, the accuracy of the developed analytical model was verified by comparison of its results with those of the published numerical simulation studies.The fracture surface of epoxy resin containing randomly dispersed spherical polymer particles or chopped glass fibres was experimentally examined to predict the self-healing efficiency of capsules by scanning electron microscopy (SEM) . In the Usually, the typical concentration of capsules mixed in self-healing material matrix is relatively low, such as in polymer composites , 35. In r uniformly distributed in the cubic sample T of side a (i.e. a representative volume element (RVE) satisfying r<<a) and VV denotes the volume fraction of capsules inside the sample. The capsule-based self-healing virtual material is considered to be a homogeneous matrix.As shown in n, hit by a random sectioning plane with area AT in the sample isV0 is the single capsule volume and N is the total amount of spherical capsules present inside the sampling region. So, the volume of healing agent released on the per area of crack is given byVRVE = a3, it obtainsAs it is deduced in the Appendix A, the probability that a spherical capsule in the cubic sample hit by a random sectioning planar crack is given by Eq . Then, ted by Eq . From EqVV\u22c5VRVEV0in whichX=n\u22c5V0ATAlternatf (f<1) which characterizes the discount is necessary and well-defined. Namely, when a capsule is fractured upon intersection by a crack, a part of the healing agent with volume fraction fV0 is released and flows in the crack. So, repeating the above process the volume of healing agent released on the per area of crack becomesIn practice, it is unlikely for a ruptured capsule to fully release its content. The volume of healing agent to be released may be discounted because of the effect of the size and the shell materials of capsule and the viscosity of healing agent, etc. Consequently, the dosage of healing agent to be released should be discounted. Hence, a factor h and radius r uniformly distributed in the cubic sample T of side a (i.e. a representative volume element (RVE) satisfying h, r << a) and VV denotes the volume fraction of capsules inside the sample. The capsule-based self-healing virtual material is considered to be a homogeneous matrix. As it is deduced in the Appendix A, the probability that a spherocylinder in the cubic sample hit by a random sectioning planar crack can be expressed by Eq . Then Eq  which characterizes the discount is interesting.For the case of spherocylindrical capsule, a similar discussion can be conducted when only a fraction of the capsule content is released from the embedded capsules as was done for the spherical capsules. Namely, a factor When spherical capsules are employed in the self-healing system, the analytical expression Eq  of self-V0 = 15.7 \u03bcm3 (i.e. a capsule diameter 2r = 3.11 \u03bcm) and volume fraction VV = 0.10, an average volume per area is found of X = 0.3107 \u03bcm3/\u03bcm2 via the presented formula Eq (3/\u03bcm2. V0)1/3, for a given volume fraction VV, can simply be derived from Eq 1/3 = 0.81, 1.61, 2.51, 3.22, 5.01, 6.31 \u03bcm, it can be drawn the line graph of X via (V0)1/3 according to Eq 1/3 is consistent with the trend as demonstrated in Eq 1/3\u22c5VVAs shownstigated  23]. It. ItV0 = 4\u03c0)1/3\u22c5VVAs shownV0 = 15.7 \u03bcm3 and an aspect ratio \u03c4 = 5 (i.e. h = 8r) and volume fraction 0.10, an average volume per area is found of Y = 0.487 \u03bcm3/\u03bcm2 via formula Eq 1/3, for a given volume fraction VV, can easily be derived by Eq 1/3 = 1.69, 2.49, 3.21, 5.00, 6.31 \u03bcm, graph of Y with respect to (V0)1/3 on the basis of Eq 1/3 is consistent with the trend as demonstrated in Eq 1/3 for different capsule concentrations and aspect ratio at random capsule orientation can be obtained. From the analytical expression Y, i.e. Eqs (Y/ (V0)1/3 is a function of the aspect ratio \u03c4 and volume fraction VV. Both the curve Y/ (V0)1/3 and the numerical values (Y/ (V0)1/3 and \u03c4. From Y/ (V0)1/3 is improved increases as the aspect ratio increases for a given healing capacity of a single capsule. When the volume fraction and aspect ratio of embedded sphereocylindical capsules gets bigger, the deviations bewteen theoretical results and simulated values of Y/ (V0)1/3 also grows. The deviations may be originated from the ignoring of the overlapping among the embedded capsules, especially as the aspect ratio and the content are both increasing. Furthermore, for real materials containing elongated particles at a higher volume fraction (e.g. VV>0.1) alignment of the particles is almost unavoidable and isotropic distributions are unrealistic.Also, the relationship between the efficiency and the aspect ratio can be investigated from Eq . Here, Yi.e. Eqs  and 10)Y/ (V0)1/l values  given byY/X which represents the ratio of the volume of healing agent to be released on the per area of crack can be obtained from Eqs Y/X whichY/X is an analytical formula that characterizes the quotient of the determined slopes for spherocylindrical and spherical capsules at a fixed total capsule volume fraction. If the volume fraction of two types of capsules are equal and the size of spherical capsules with fixed volume which will be embedded in the matrix is given, the efficiency of healing agent released from spherocylindrical capsules employed in self-healing system increases as the aspect ratio or the volume of the type of spherocylindrical capsule grows as shown in \u03c3 = 0.2, 0.5, 1  embedded. Just when \u03c3 = 1 and \u03c4 = 1, the efficiencies are equal for the two types of capsules. Therefore, both shape and size of capsules should be jointly investigated to improve the efficiency of healing agent released in capsule-based self-healing composite materials. This point is opposed with the claim [RIF is a function of the capsule aspect ratio only and is independent of the volume fraction and the capsule volume\u2019.Actually, he claim  that \u2018foIn this contribution the effects of capsule shape on the efficiency of healing agent to be released in capsule-based self-healing composite materials are conducted. When capsules are randomly distributed in the matrix and a crack occurs and grows, the analytical expression of efficiency of healing agent released by spherical or spherocylindrical capsules are stemmed from a mathematically rigorous reasoning via the theory of geometrical probability and integral geometry. The crack opening distance is chosen to characterize the healing potential of individual cracks in the models. Furthermore, the reliabilities of the developed models can be verified by data from relevant literature information, which was implemented via numerical simulation. It was found that both shape and size of capsules should be jointly investigated to improve the efficiency of healing agent to be released in capsule-based self-healing composite materials. This point is opposed with the existing claim. As a result of the model, the volume fraction of capsules required to be embedded in matrix can be determined via the developed efficiency model for different type of shaped capsules. The results of the analytical models will serve to understand the probability of crack intersection with capsules and guide the further development of spherical or elongated liquid filled capsules in capsule-based self-healing composite materials.The probability that a randomly chosen crack plane meets the capsule could be obtained by the theory of Integral Geometry as follows.K0, K1 be convex sets in En such that K1 \u2282 K0. The probability that a randomly chosen r-plane Lr  that meets K0 also meets K1 isMr(\u2202K) = nWr+1(K) , and n is the dimension of space. Wr+1(K) is often called quermassintegrale or mean cross-sectional measures of a convex set K introduced by Minkowski, while Mr(\u2202K) is the integrals of mean curvature of the boundary \u2202K of a convex set K [n = 3, r = 2, it becomesLet ex set K . For n =K1 with a capsule, a K0 with a sampling region . For a spherical capsule K1 with radius r, it holds [K0 with edge a, it hasK0 also meets the capsule K1 isIn the capsule-based self-healing model material it equates a convex body it holds W2(K1)=(=(4\u03c0r)/3,For the 2(K0)=\u03c0a,Hence, fParallel convex sets in the theory of Integral Geometry is employed. Parallel convex sets: The parallel body K\u03c1 in the distance \u03c1 of a convex set K is the union of all solid spheres of radius \u03c1 the centers of which are points of K. The boundary \u2202K\u03c1 is called the parallel surface of \u2202K in the distance \u03c1. It is worth noting that the integral of mean curvature of the boundary \u2202K\u03c1 can be expressed by the function of the integral of mean curvature of the boundary \u2202K [Kr in the distance r of a segment set K with length h is the union of all solid spheres of radius r the centers of which are points of K. From Eq ,1,\u2026,n\u22121.So, a spE3, when K reduces to a line segment of length h, the mean curvature integrals satisfies M1(\u2202K) = \u03c0h, M2(\u2202K) = 4\u03c0. So, the mean curvature integrals of a spherocylindrical capsule isFor the ordinary space K0 also meets the capsule K1 isNamely,from Eqs  and  are M0 = area of the boundary K; M1 = integral of mean curvature of the boundary K. Then, the integrals of mean curvature can be expressed as follows [\u0394 is the breadth of K in the direction u2, that is, the distance between the two support planes of K that are perpendicular to u2 and that contain K between them. The breadth of K is also called as the mean caliper diameter in the terminology of stereology [M1 is equal, up to the factor 2\u03c0, to the mean distance between parallel support planes.For a convex body  follows M1=12\u222bU2ereology . Thus we[\u0394=M1/2\u03c0.It folloS1 Excel(XLS)Click here for additional data file.S2 Excel(XLS)Click here for additional data file.S3 Excel(XLS)Click here for additional data file.S4 Excel(XLS)Click here for additional data file."]}
{"representative": "Sensorineural hearing loss (SNHL) is the most common sensory deficit worldwide, frequently caused by noise trauma and aging, with inflammation being implicated in both pathologies. Here, we provide the first direct measurements of proinflammatory cytokines in inner ear fluid, perilymph, of adolescent and 2-year-old mice. The perilymph of adolescent mice exposed to the noise intensity resulting in permanent auditory threshold elevations had significantly increased levels of IL-6, TNF-\u03b1, and CXCL1 6 h after exposure, with CXCL1 levels being most elevated (19.3 \u00b1 6.2 fold). We next provide the first immunohistochemical localization of CXCL1 in specific cochlear supporting cells, and its presumed receptor, Duffy antigen receptor for chemokines (DARC), in hair cells and spiral ganglion neurons. Our results demonstrate the feasibility of molecular diagnostics of SNHL using only 0.5 \u03bcL of perilymph, and motivate future sub-\u03bcL based diagnostics of human SNHL based on liquid biopsy of the inner ear to guide therapy, promote hearing protection, and monitor response to treatment. Sensorineural hearing loss (SNHL) is the most common sensory deficit in the world. Disabling SNHL currently affects nearly half a billion people , and itsNoise exposure and aging are important causes of human SNHL, and noise exposure accelerates age-related hearing loss . AccordiWe focus on proinflammatory cytokines because they play an important role in a plethora of diseases , and areWhile we , 25 and N = 19 ears), perilymph collected 6 h after exposing mice to noise levels that resulted in PTS (103 dB SPL at 8\u201316 kHz for 2 h) (N = 17 ears) demonstrated a statistically significant elevation of the levels of proinflammatory cytokines CXCL1 , IL-6 , and TNF-\u03b1  or neuropathic TTS (97 dB SPL at 8\u201316 kHz for 2 h) .For cytokines with significant elevation after PTS-causing noise, the trends in cochlear and vestibular perilymph were generally similar, with vestibular perilymph showing higher inducible fluctuations than cochlear perilymph.N = 10 ears), did not show significant changes in any of the measured cytokines, confirming the specificity of the cytokine reaction to the inner ear (N = 17 ears) did demonstrate statistically significant elevations in the levels of the same three cytokines that were elevated in perilymph 6 h after PTS-causing noise exposure .The levels of proinflammatory cytokines IL-1\u03b2 and TNF-\u03b1 decreased significantly from age 8 weeks (corresponding to 2 weeks after noise exposure) to 2 years in control unexposed animals . This stands in contrast to the control animals, where IL-6 levels in vPLF did not meet our criterion for change between 2 weeks and 2 years after noise exposure.In contrast to IL-1\u03b2 and TNF-\u03b1, IL-6 levels increased significantly at 8 weeks of age in all analyzed samples regardless of noise exposure . The obsp = 0.0033), and at 2 weeks compared to 6 h after exposure to neuropathic TTS in vPLF (p = 0.0147). In contrast, CXCL1 levels increased significantly in the blood of 2-year-old mice compared to 6-week-old mice regardless of noise exposure .The level of CXCL1 decreased significantly at 2 years compared to 6 h after exposure to non-neuropathic TTS in cPLF -related cytokines , and immunoregulatory (IL-10 and IL-12) cytokines in the perilymph and CSF of 2-year-old animals showed decreased values compared to young animals, regardless of noise exposure . Howeverp = 0.0092 for IL-1\u03b2, p = 0.0041 for IL-6, p < 0.0001 for TNF-\u03b1, p < 0.0001 for CXCL1; 94 dB SPL group: p = 0.0048 for IL-1\u03b2, p = 0.0360 for IL-6, p = 0.0076 for TNF-\u03b1, p = 0.0256 for CXCL1; 97 dB SPL group: p = 0.0127 for IL-1\u03b2, p < 0.0001 for IL-6, p < 0.0001 for TNF-\u03b1, p = 0.0093 for CXCL1; p = 0.0385), IL-5 levels were reduced in old animals of all groups . The blood levels of immunoregulatory cytokine IL-10 were increased in old compared to young animals . In contrast, blood IL-12 levels were similar between young and old animals, regardless of noise exposure  to identify CXCL1-positive cells  and noise-traumatized mice sacrificed 6 h after PTS-causing noise exposure  showed a noticeable decrease in CXCL1 immunoreactivity in pillar cells. The reduced CXCL1 expression was detectable in the cochlear base  revealed that the cochlear cells expressing Iba1 did not co-express CXCL1    . The anaanimals) . Consideanimals) . In contanimals) , DARC imanimals) . A semi-N = 4 animals Within the peripheral vestibular system, specific immunoreactivity for DARC was found within the crista ampullaris  by RT-PCR in Sprague-Dawley rats . In a foTnip1, a gene encoding the \u201ctumor necrosis factor, alpha-induced protein 3\u201d was expressed at higher levels in mice resistant to noise exposure. This protein is known to inhibit TNF-mediated apoptosis and NF-kappa B activation.When comparing mouse strains with different susceptibility to noise-induced hearing loss, several immune-related genes were reported to be upregulated in the susceptible mice . In addiHaemophilus influenzae to model acute otitis media  within the mammalian cochlea, prior studies that analyzed pooled inner ear tissue noted upregulation of CXCL1 mRNA during cochlear inflammation and development. Specifically, CXCL1 mRNA was upregulated in the inner ear tissue of mice with chronic otitis media, based on qRT-PCR analysis . FurtherOur finding of CXCL1 expression in the pillar cells, Deiters cells, interdental cells, and vestibular supporting cells of control animals suggests constitutive CXCL1 expression in the inner ear under physiologic conditions, and implicates these cell types in immune and inflammatory regulation in the inner ear. Our finding of reduced CXCL1 expression in pillar cells coupled with the elevated CXCL1 levels in perilymph after acoustic trauma suggests CXCL1 release into perilymph after pathologic noise exposure that damages pillar cells. The noise-induced elevation of CXCL1 levels in perilymph could also reflect higher production in the cochlear microenvironment. Since macrophages did not express CXCL1 6 h after acoustic trauma, the CXCL1-positive supporting cells appear to be the main producers of CXCL1. Relevantly, both pillar and Deiters cells express transforming growth factor-\u03b2-activated kinase-1 (TAK1) , a potenApart from its proinflammatory activity, CXCL1 may play a neuromodulatory role in the inner ear given the close proximity of nerve fibers within the organ of Corti and CXCL1-expressing supporting cells . This hyPlasmodium vivax and Plasmodium knowlesi), its primary function is the sequestration and transcytosis of chemokines  was noted at 3 months  of either sex were used in an estimated 50/50 ratio. They were randomly assigned to different noise exposure groups or to the control group at 6 weeks of age. Animal weight was comparable in all groups. Experiments were designed to typically have one mouse from each group housed in any given cage. When animals were not used for one of the interventions, they were kept in our animal care facility with 0 dB SPL . A totalExperiments were carried out as described in the publication from our laboratory that established the noise levels that cause neuropathic TTS, non-neuropathic TTS and PTS in the cochlear base, specifically the areas where tones with frequencies of ~25 kHz and higher are processed . BrieflyFor perilymph sampling we used the approach developed by Salt's and Hirose's laboratories . BrieflyAfter bilateral specimen collection from the PSCs, CSF was collected from the cisterna magna as previously described . BrieflyAs the final procedure for every animal, a blood sample was obtained by cardiac puncture after thoracotomy. The sample was transferred into a serum gel with a clotting activator tube  and left standing upright at room temperature for 30 min. It was then spun down  and the supernatant was transferred into an Eppendorf tube that was sealed with parafilm and stored at \u221280\u00b0C.The V-PLEX Proinflammatory Panel 1 Mouse Kit  was used to analyze the perilymph, CSF, and blood samples. It is an immunoassay based on electrochemiluminescence that quantifies the levels of the following cytokines: IFN-\u03b3, IL-1\u03b2, IL-2, IL-4, IL-5, IL-6, CXCL1, IL-10, IL-12p70, and TNF-\u03b1. Briefly, samples and corresponding standards  were added into wells of MSD MULTI-SPOT 96-well plates, pre-coated with capture antibodies, and incubated for 2 h at room temperature. Plates were washed three times with 150 \u03bcL/well of washing buffer, and 25 \u03bcL of detection antibody solution containing antibody conjugated with electrochemiluminescent labels (MSD SULFO-TAG) was applied into each well. Samples were incubated for an additional two h, then washed as described before, and treated with 2X Read Buffer T. Electrochemiluminescence was measured on the matching MSD SI2400 instrument. Concentration of cytokines was determined from electrochemiluminescence signals fitted to the calibration curve.Cochlear whole mounts were dissected and mounted as described previously . Immunofp < 0.05), pair-wise comparison was performed and Bonferroni correction was applied for multiple comparisons. When variances were not equal, Kruskal-Wallis test was used. If the test was significant (p < 0.05), Wilcoxon rank-sum test was applied, followed by Bonferroni correction. Composite graphs showing individual and average values were constructed using GraphPad PRISM.GraphPad PRISM  was used for all statistical analyses. For cytokine measurements, Bartlett's test was used to check for homoscedasticity. When variances among the groups were equal, one-way ANOVA was used to compare the groups. If ANOVA was significant (All datasets generated for this study are included in the manuscript/The animal study was reviewed and approved by Institutional Animal Care and Use Committee at Massachusetts Eye and Ear.KMS conceived the project, designed experiments, and supervised all aspects of research. Perilymph samples were collected by LDL, TF, and VYS. Noise exposures were carried out by LDL and RS. Dissection of whole mounts was performed by LDL, SV, and RS. Immunohistochemical staining, confocal microscopy, and image analysis was performed by SV. Perilymph samples were processed by LDL, SV, and LX. TF performed statistical analyses of perilymph samples. LDL, SV, and KMS wrote the manuscript with editorial input from all other authors.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.", "texts": ["Sensorineural hearing loss (SNHL) is the most common sensory deficit worldwide, frequently caused by noise trauma and aging, with inflammation being implicated in both pathologies. Here, we provide the first direct measurements of proinflammatory cytokines in inner ear fluid, perilymph, of adolescent and 2-year-old mice. The perilymph of adolescent mice exposed to the noise intensity resulting in permanent auditory threshold elevations had significantly increased levels of IL-6, TNF-\u03b1, and CXCL1 6 h after exposure, with CXCL1 levels being most elevated (19.3 \u00b1 6.2 fold). We next provide the first immunohistochemical localization of CXCL1 in specific cochlear supporting cells, and its presumed receptor, Duffy antigen receptor for chemokines (DARC), in hair cells and spiral ganglion neurons. Our results demonstrate the feasibility of molecular diagnostics of SNHL using only 0.5 \u03bcL of perilymph, and motivate future sub-\u03bcL based diagnostics of human SNHL based on liquid biopsy of the inner ear to guide therapy, promote hearing protection, and monitor response to treatment. Sensorineural hearing loss (SNHL) is the most common sensory deficit in the world. Disabling SNHL currently affects nearly half a billion people , and itsNoise exposure and aging are important causes of human SNHL, and noise exposure accelerates age-related hearing loss . AccordiWe focus on proinflammatory cytokines because they play an important role in a plethora of diseases , and areWhile we , 25 and N = 19 ears), perilymph collected 6 h after exposing mice to noise levels that resulted in PTS (103 dB SPL at 8\u201316 kHz for 2 h) (N = 17 ears) demonstrated a statistically significant elevation of the levels of proinflammatory cytokines CXCL1 , IL-6 , and TNF-\u03b1  or neuropathic TTS (97 dB SPL at 8\u201316 kHz for 2 h) .For cytokines with significant elevation after PTS-causing noise, the trends in cochlear and vestibular perilymph were generally similar, with vestibular perilymph showing higher inducible fluctuations than cochlear perilymph.N = 10 ears), did not show significant changes in any of the measured cytokines, confirming the specificity of the cytokine reaction to the inner ear (N = 17 ears) did demonstrate statistically significant elevations in the levels of the same three cytokines that were elevated in perilymph 6 h after PTS-causing noise exposure .The levels of proinflammatory cytokines IL-1\u03b2 and TNF-\u03b1 decreased significantly from age 8 weeks (corresponding to 2 weeks after noise exposure) to 2 years in control unexposed animals . This stands in contrast to the control animals, where IL-6 levels in vPLF did not meet our criterion for change between 2 weeks and 2 years after noise exposure.In contrast to IL-1\u03b2 and TNF-\u03b1, IL-6 levels increased significantly at 8 weeks of age in all analyzed samples regardless of noise exposure . The obsp = 0.0033), and at 2 weeks compared to 6 h after exposure to neuropathic TTS in vPLF (p = 0.0147). In contrast, CXCL1 levels increased significantly in the blood of 2-year-old mice compared to 6-week-old mice regardless of noise exposure .The level of CXCL1 decreased significantly at 2 years compared to 6 h after exposure to non-neuropathic TTS in cPLF -related cytokines , and immunoregulatory (IL-10 and IL-12) cytokines in the perilymph and CSF of 2-year-old animals showed decreased values compared to young animals, regardless of noise exposure . Howeverp = 0.0092 for IL-1\u03b2, p = 0.0041 for IL-6, p < 0.0001 for TNF-\u03b1, p < 0.0001 for CXCL1; 94 dB SPL group: p = 0.0048 for IL-1\u03b2, p = 0.0360 for IL-6, p = 0.0076 for TNF-\u03b1, p = 0.0256 for CXCL1; 97 dB SPL group: p = 0.0127 for IL-1\u03b2, p < 0.0001 for IL-6, p < 0.0001 for TNF-\u03b1, p = 0.0093 for CXCL1; p = 0.0385), IL-5 levels were reduced in old animals of all groups . The blood levels of immunoregulatory cytokine IL-10 were increased in old compared to young animals . In contrast, blood IL-12 levels were similar between young and old animals, regardless of noise exposure  to identify CXCL1-positive cells  and noise-traumatized mice sacrificed 6 h after PTS-causing noise exposure  showed a noticeable decrease in CXCL1 immunoreactivity in pillar cells. The reduced CXCL1 expression was detectable in the cochlear base  revealed that the cochlear cells expressing Iba1 did not co-express CXCL1    . The anaanimals) . Consideanimals) . In contanimals) , DARC imanimals) . A semi-N = 4 animals Within the peripheral vestibular system, specific immunoreactivity for DARC was found within the crista ampullaris  by RT-PCR in Sprague-Dawley rats . In a foTnip1, a gene encoding the \u201ctumor necrosis factor, alpha-induced protein 3\u201d was expressed at higher levels in mice resistant to noise exposure. This protein is known to inhibit TNF-mediated apoptosis and NF-kappa B activation.When comparing mouse strains with different susceptibility to noise-induced hearing loss, several immune-related genes were reported to be upregulated in the susceptible mice . In addiHaemophilus influenzae to model acute otitis media  within the mammalian cochlea, prior studies that analyzed pooled inner ear tissue noted upregulation of CXCL1 mRNA during cochlear inflammation and development. Specifically, CXCL1 mRNA was upregulated in the inner ear tissue of mice with chronic otitis media, based on qRT-PCR analysis . FurtherOur finding of CXCL1 expression in the pillar cells, Deiters cells, interdental cells, and vestibular supporting cells of control animals suggests constitutive CXCL1 expression in the inner ear under physiologic conditions, and implicates these cell types in immune and inflammatory regulation in the inner ear. Our finding of reduced CXCL1 expression in pillar cells coupled with the elevated CXCL1 levels in perilymph after acoustic trauma suggests CXCL1 release into perilymph after pathologic noise exposure that damages pillar cells. The noise-induced elevation of CXCL1 levels in perilymph could also reflect higher production in the cochlear microenvironment. Since macrophages did not express CXCL1 6 h after acoustic trauma, the CXCL1-positive supporting cells appear to be the main producers of CXCL1. Relevantly, both pillar and Deiters cells express transforming growth factor-\u03b2-activated kinase-1 (TAK1) , a potenApart from its proinflammatory activity, CXCL1 may play a neuromodulatory role in the inner ear given the close proximity of nerve fibers within the organ of Corti and CXCL1-expressing supporting cells . This hyPlasmodium vivax and Plasmodium knowlesi), its primary function is the sequestration and transcytosis of chemokines  was noted at 3 months  of either sex were used in an estimated 50/50 ratio. They were randomly assigned to different noise exposure groups or to the control group at 6 weeks of age. Animal weight was comparable in all groups. Experiments were designed to typically have one mouse from each group housed in any given cage. When animals were not used for one of the interventions, they were kept in our animal care facility with 0 dB SPL . A totalExperiments were carried out as described in the publication from our laboratory that established the noise levels that cause neuropathic TTS, non-neuropathic TTS and PTS in the cochlear base, specifically the areas where tones with frequencies of ~25 kHz and higher are processed . BrieflyFor perilymph sampling we used the approach developed by Salt's and Hirose's laboratories . BrieflyAfter bilateral specimen collection from the PSCs, CSF was collected from the cisterna magna as previously described . BrieflyAs the final procedure for every animal, a blood sample was obtained by cardiac puncture after thoracotomy. The sample was transferred into a serum gel with a clotting activator tube  and left standing upright at room temperature for 30 min. It was then spun down  and the supernatant was transferred into an Eppendorf tube that was sealed with parafilm and stored at \u221280\u00b0C.The V-PLEX Proinflammatory Panel 1 Mouse Kit  was used to analyze the perilymph, CSF, and blood samples. It is an immunoassay based on electrochemiluminescence that quantifies the levels of the following cytokines: IFN-\u03b3, IL-1\u03b2, IL-2, IL-4, IL-5, IL-6, CXCL1, IL-10, IL-12p70, and TNF-\u03b1. Briefly, samples and corresponding standards  were added into wells of MSD MULTI-SPOT 96-well plates, pre-coated with capture antibodies, and incubated for 2 h at room temperature. Plates were washed three times with 150 \u03bcL/well of washing buffer, and 25 \u03bcL of detection antibody solution containing antibody conjugated with electrochemiluminescent labels (MSD SULFO-TAG) was applied into each well. Samples were incubated for an additional two h, then washed as described before, and treated with 2X Read Buffer T. Electrochemiluminescence was measured on the matching MSD SI2400 instrument. Concentration of cytokines was determined from electrochemiluminescence signals fitted to the calibration curve.Cochlear whole mounts were dissected and mounted as described previously . Immunofp < 0.05), pair-wise comparison was performed and Bonferroni correction was applied for multiple comparisons. When variances were not equal, Kruskal-Wallis test was used. If the test was significant (p < 0.05), Wilcoxon rank-sum test was applied, followed by Bonferroni correction. Composite graphs showing individual and average values were constructed using GraphPad PRISM.GraphPad PRISM  was used for all statistical analyses. For cytokine measurements, Bartlett's test was used to check for homoscedasticity. When variances among the groups were equal, one-way ANOVA was used to compare the groups. If ANOVA was significant (All datasets generated for this study are included in the manuscript/The animal study was reviewed and approved by Institutional Animal Care and Use Committee at Massachusetts Eye and Ear.KMS conceived the project, designed experiments, and supervised all aspects of research. Perilymph samples were collected by LDL, TF, and VYS. Noise exposures were carried out by LDL and RS. Dissection of whole mounts was performed by LDL, SV, and RS. Immunohistochemical staining, confocal microscopy, and image analysis was performed by SV. Perilymph samples were processed by LDL, SV, and LX. TF performed statistical analyses of perilymph samples. LDL, SV, and KMS wrote the manuscript with editorial input from all other authors.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest."]}
{"representative": "An introduction to a series of essays honoring Erich Meyerhoff (1919\u20132015), AHIP, FMLA, who was active in and contributed to the Medical Library Association for generations. Journal of the Medical Library Association (JMLA), to catch a glimpse of him and understand why he is honored with a festschrift sponsored by the Fellows of the Medical Library Association (MLA).A few times in each generation, we count ourselves fortunate if we have had the opportunity to know an extraordinary individual. Such an individual was Erich Meyerhoff, AHIP, FMLA (1919\u20132015), who marked his time not simply by living a very long life, but by doing, creating, enabling, and inspiring those around him. He had a passion for his profession and the individuals who made up that profession. Those of us who were not fortunate to know him personally now have the opportunity, through the series of essays published in this issue of the JMLA, provided an overview of his career and, most notably, comments from his peers [Erich was active in and contributed to MLA for generations. His legacy is one of unparalleled support for and encouragement of MLA and its members. His obituary, published in is peers . DescripThe series of essays in this festschrift provides a snapshot of an extraordinary individual who exemplified professionalism and an abiding faith in social justice and the possibilities of what an organization such as MLA could achieve in the twentieth and twenty-first centuries. This festschrift is meant not only to honor Erich, but to provide an example of a professional life well lived for current and future members of MLA. His activities and accomplishments were recognized by MLA through the Marcia C. Noyes Award, the Janet Doe Lectureship, and MLA Fellowship, but there was much more to Erich than these important awards or his longevity.In their essay, \u201cErich Meyerhoff: A Man for All Medical Librarians,\u201d Judith Messerle, AHIP, FMLA, and Lucretia W. McClure, AHIP, FMLA, provide a sketch of his life, education, career, and accomplishments, which spanned many significant developments in health sciences librarianship . They noUnion Catalog of Medical Periodicals and lasted as a resource center and service bureau from 1960 to 2003.Patricia E. Gallagher, AHIP, FMLA, traces the development of the Medical Library Center of New York in her essay, \u201cLibrary Resource Sharing and the Medical Library Center of New York\u201d . The cenElaine Russo Martin, FMLA, defines and reviews democratic librarianship in her essay, \u201cDemocratic Librarianship: The Role of the Medical Library in Promoting Democracy and Social Justice\u201d . ThroughWayne J. Peay, FMLA, and Helen-Ann Brown Epstein, AHIP, FMLA, update the now historic tenth Janet Doe Lecture, which Erich presented in 1977, in their essay, \u201cThe Tenth Doe Lecture: A Forty-Year Perspective: Still Relevant after All These Years\u201d . The lecFinally, Stephen J. Greenberg, AHIP, provides a window into the world of historical writing and how it changed over the course of Erich\u2019s life in his essay, \u201cMedical History: As It Was; As It Will Be\u201d . GreenbeThis series of essays honoring Erich Meyerhoff grew out of discussions of the MLA Fellows group during their annual meeting in conjunction with the MLA annual meeting. A small task force was established to define topics for the festschrift essays and engage authors. I thank the members of the Meyerhoff Task Force: Helen-Ann Brown Epstein, AHIP, FMLA, Patricia E. Gallagher, AHIP, FMLA, Stephen J. Greenberg, AHIP, J. Michael Homan, AHIP, FMLA (chair), and Lucretia W. McClure, AHIP, FMLA.J. Michael Homan, AHIP, FMLA,homan@mayo.edu, Emeritus Director of Libraries, Assistant Professor of Biomedical Informatics, and Emeritus Consultant, Health Sciences Research, Mayo Clinic, Rochester, MN", "texts": ["An introduction to a series of essays honoring Erich Meyerhoff (1919\u20132015), AHIP, FMLA, who was active in and contributed to the Medical Library Association for generations. Journal of the Medical Library Association (JMLA), to catch a glimpse of him and understand why he is honored with a festschrift sponsored by the Fellows of the Medical Library Association (MLA).A few times in each generation, we count ourselves fortunate if we have had the opportunity to know an extraordinary individual. Such an individual was Erich Meyerhoff, AHIP, FMLA (1919\u20132015), who marked his time not simply by living a very long life, but by doing, creating, enabling, and inspiring those around him. He had a passion for his profession and the individuals who made up that profession. Those of us who were not fortunate to know him personally now have the opportunity, through the series of essays published in this issue of the JMLA, provided an overview of his career and, most notably, comments from his peers [Erich was active in and contributed to MLA for generations. His legacy is one of unparalleled support for and encouragement of MLA and its members. His obituary, published in is peers . DescripThe series of essays in this festschrift provides a snapshot of an extraordinary individual who exemplified professionalism and an abiding faith in social justice and the possibilities of what an organization such as MLA could achieve in the twentieth and twenty-first centuries. This festschrift is meant not only to honor Erich, but to provide an example of a professional life well lived for current and future members of MLA. His activities and accomplishments were recognized by MLA through the Marcia C. Noyes Award, the Janet Doe Lectureship, and MLA Fellowship, but there was much more to Erich than these important awards or his longevity.In their essay, \u201cErich Meyerhoff: A Man for All Medical Librarians,\u201d Judith Messerle, AHIP, FMLA, and Lucretia W. McClure, AHIP, FMLA, provide a sketch of his life, education, career, and accomplishments, which spanned many significant developments in health sciences librarianship . They noUnion Catalog of Medical Periodicals and lasted as a resource center and service bureau from 1960 to 2003.Patricia E. Gallagher, AHIP, FMLA, traces the development of the Medical Library Center of New York in her essay, \u201cLibrary Resource Sharing and the Medical Library Center of New York\u201d . The cenElaine Russo Martin, FMLA, defines and reviews democratic librarianship in her essay, \u201cDemocratic Librarianship: The Role of the Medical Library in Promoting Democracy and Social Justice\u201d . ThroughWayne J. Peay, FMLA, and Helen-Ann Brown Epstein, AHIP, FMLA, update the now historic tenth Janet Doe Lecture, which Erich presented in 1977, in their essay, \u201cThe Tenth Doe Lecture: A Forty-Year Perspective: Still Relevant after All These Years\u201d . The lecFinally, Stephen J. Greenberg, AHIP, provides a window into the world of historical writing and how it changed over the course of Erich\u2019s life in his essay, \u201cMedical History: As It Was; As It Will Be\u201d . GreenbeThis series of essays honoring Erich Meyerhoff grew out of discussions of the MLA Fellows group during their annual meeting in conjunction with the MLA annual meeting. A small task force was established to define topics for the festschrift essays and engage authors. I thank the members of the Meyerhoff Task Force: Helen-Ann Brown Epstein, AHIP, FMLA, Patricia E. Gallagher, AHIP, FMLA, Stephen J. Greenberg, AHIP, J. Michael Homan, AHIP, FMLA (chair), and Lucretia W. McClure, AHIP, FMLA.J. Michael Homan, AHIP, FMLA,homan@mayo.edu, Emeritus Director of Libraries, Assistant Professor of Biomedical Informatics, and Emeritus Consultant, Health Sciences Research, Mayo Clinic, Rochester, MN"]}
{"representative": "Pundamilia pundamilia and P. sp. \u2018red head\u2019). The SNP markers were distributed on 22 linkage groups and the total map size was 1,594 cM with an average marker distance of 1.01 cM. This high-resolution genetic linkage map was used to anchor the scaffolds of the Pundamilia genome and estimate recombination rates along the genome. Via QTL mapping we identified a major QTL for sex in a \u223c1.9 Mb region on Pun-LG10, which is homologous to Oreochromis niloticus LG 23 (Ore-LG23) and includes a well-known vertebrate sex-determination gene (amh).Genetic linkage maps are essential for comparative genomics, high quality genome sequence assembly and fine scale quantitative trait locus (QTL) mapping. In the present study we identified and genotyped markers via restriction-site associated DNA (RAD) sequencing and constructed a genetic linkage map based on 1,597 SNP markers of an interspecific F2 cross of two closely related Lake Victoria cichlids ( Paralabidochromis chilotes and Paralabidochromis sauvagei and contained 184 microsatellites and two SNP markers with a mean marker spacing of 6.09 cM on 25 linkage groups , namely LG 1 (XY), LG 3 (ZW), and LG 23 (XY)  and the anti M\u00fcllerian hormone (amh) might have been re-used as sex determination loci . The map was built using 1,597 SNPs identified and genotyped via restriction-site associated DNA (RAD) sequencing with an average marker distance of 1.01 cM. We then used the linkage map to anchor the scaffolds of the P. nyererei reference genome to the 22 linkage groups of the map and to perform a QTL analysis for putative sex determination loci in Pundamilia. We identify the LG determining sex in a Lake Victoria cichlid cross, as well as potential candidate genes for sex determination and put these findings into the context of sex determination evolution within a rapidly radiating clade of fish.In the present study we construct a linkage map of an interspecific F2 cross between two very closely related Lake Victoria cichlid species (Pundamilia sp. \u2018red head\u2019 (th or 5th lab generation) and a wild P. pundamilia female caught by OS at Makobe Island in Lake Victoria in 2003. Eggs were removed from the female\u2019s mouth five days after spawning and reared in isolation from the adults. After reaching maturity, four F1 individuals were crossed, resulting in two F2 families with together more than 300 individuals. When F2 individuals were adult and sexually mature sex was determined based on coloration, then sedated fish were killed with MS222 , and a fin clip was taken and stored in 98% ethanol for genetic analyses . Genomic DNA of 218 F2 progeny, the four F1 parents, and the two F0 grandparents was extracted using phenol-chloroform  each on a single lane of an Illumina HighSequation 2500 platform either at the Next Generation Sequencing Platform of the University of Bern or at the Genomic Technologies Facility of the University of Lausanne. Some individuals and all F0 grandparents were sequenced in up to three libraries to increase coverage. Together with each library, we sequenced about 10% reads of bacteriophage PhiX genomic DNA (Illumina Inc.) to increase complexity at the first 10 sequenced base pairs. During read processing, PhiX reads were further utilized to recalibrate libraries to equalize base quality scores across Illumina lanes utilizing GATK version 3.2  and filtered using FASTX Toolkit 0.0.13 (http://hannonlab.cshl.edu/fastx_toolkit/index.html) requiring a minimum quality of 10 at all bases and of 30 in at least 95% of the read. After PhiX removal, reads were demultiplexed, cleaned, and trimmed to 92 bp with process_radtags implemented in Stacks v1.26 (P. nyererei reference genome (https://github.com/jpuritz/dDocent/blob/master/scripts/dDocent_filters), genotypes were further excluded (thresholds given in brackets) on criteria related to allelic balance at heterozygote sites , quality vs. depth (ratio <0.5), strand presentation (overlapping forward and reverse reads), and site depth . Multi-allelic variants and indels were removed, resulting in 7,401 SNPs. Of the 7,401 filtered SNPs 2,052 were alternative homozygous in the grandparents, and were used to build the genetic linkage map.Before recalibration, read qualities were inspected using fastQC (e genome . Mapped P < 0.001) were excluded for linkage map reconstruction. Linkage groups were identified based on an independent logarithm of odds (LOD) threshold of 12. Unlinked markers were excluded. The strongest cross-link (SCL) in the final map is 5.4. The linkage map was built using the regression mapping algorithm, a recombination frequency smaller than 0.40, and an LOD larger than 3. Up to three rounds of marker positioning were conducted with a jump threshold of 5. A ripple was performed after the addition of each new marker. Map distances were calculated using the Kosambi mapping function. All markers resolved onto 22 linkage groups were matched to positions in the Oreochromis niloticus genome using a chain file  identified during mapping (see paragraph above). We ordered and oriented the scaffolds with ALLMAPS (Pundamilia nyererei reference (Pundamilia reference version 2.0). Chain files were produced with ALLMAPS and in the opposite direction using chainSwap from kentUtils (https://github.com/ENCODE-DCC/kentUtils). We could then use the chain file to liftover the position of all 7,401 genotyped loci, using Picard liftoverVcf (http://broadinstitute.github.io/picard/index.html). In addition, we generated a new version of the NCBI Pundamilia nyererei RefSeq annotation file with the positions for reference version 2.0 by lifting over the positions from the NCBI PunNye1.0 annotation release 101 (https://www.ncbi.nlm.nih.gov/genome/annotation_euk/Pundamilia_nyererei/101/#BuildInfo) using the UCSC liftOver tool  are deposited on short read archive SRA accession SRP136207. Supplemental material available at Figshare: https://doi.org/10.25387/g3.6221921.All genomic resources see , the genPundamilia linkage map, 1,182 markers could be positioned onto Oreochromis niloticus linkage groups (Ore-LG). The linkage map comprises 22 linkage groups containing 1,597 markers with an average marker distance of 1.01 cM adding up to a total map length of 1593.72 cM , Table 1Pundamilia linkage map provides a new chromosome framework for whole genome sequence assembly and map integration with more anchoring points then previous published maps. The anchored genome encompasses 78.7% of the total bases  of the original P. nyererei reference genome based on 383 anchored scaffolds, of which 233 are now oriented. This is a slightly higher fraction than in the Lake Malawi cichlid Metriaclima zebra, where 564,259,264 bp (66.5%) of the genome sequence could be anchored to linkage groups . We did not find any further associations on any of the other LGs. Ore-LG23 has been previously identified as one potential XY sex-determining LG in Oreochromis . This suggests that none of the markers used to build the linkage map are determining sex directly, but that the causal locus can be found close by and indicates that there are no further major genetic determiners of sex segregating in this cross. Investigating the segregation patterns in the larger of the F2 mapping-families (n = 122) more in detail revealed that the loci selected to build the map  and male (BB) and heterozygous in both F1 (AB)) segregate as expected in a 50:50 ratio of AA:AB in F2 females and AB:BB in F2 males . Among them is the anti-m\u00fcllerian hormone (amh), a master gene for sex determination in other fish. Amh is part of the transforming growth factor beta pathway, responsible for the regression of M\u00fcllerian ducts in tetrapods , a mutation in the receptor of the amh (amhrII) determines sex (amhy (Y chromosome-specific anti-m\u00fcllerian hormone) gene has been inserted upstream of amh in the cascade of male development in the neotropical silverside Odonthestes hatcheri  and in Astatotilapia calliptera on LG7 (gsdf) (Pundamilia Pun-LG10 (Ore-LG 23) acts as an (evolving) sex chromosome, even though it might not be the only region controlling sex in Pundamilia. The anti-m\u00fcllerian hormone amh (or a derived copy) appears to be a strong candidate influencing sexual development in Pundamilia, but further work is warranted to characterize the genomic candidate region and the impact of this candidate gene on sex determination.Within our mapping interval of \u223c1.9 Mb, 65 genes, based on the NCBI annotation for the new 7 (gsdf) . Our resamh, nor Pun-LG10 or a homologous region was invoked in sex determination in other Lake Victoria cichlids that have previously been used for mapping sex (A recent meta-analysis showed that transitions between sex determination systems are frequent across fish species, including transitions to and between heteromorphic sex chromosomes (ping sex , this ma", "texts": ["Pundamilia pundamilia and P. sp. \u2018red head\u2019). The SNP markers were distributed on 22 linkage groups and the total map size was 1,594 cM with an average marker distance of 1.01 cM. This high-resolution genetic linkage map was used to anchor the scaffolds of the Pundamilia genome and estimate recombination rates along the genome. Via QTL mapping we identified a major QTL for sex in a \u223c1.9 Mb region on Pun-LG10, which is homologous to Oreochromis niloticus LG 23 (Ore-LG23) and includes a well-known vertebrate sex-determination gene (amh).Genetic linkage maps are essential for comparative genomics, high quality genome sequence assembly and fine scale quantitative trait locus (QTL) mapping. In the present study we identified and genotyped markers via restriction-site associated DNA (RAD) sequencing and constructed a genetic linkage map based on 1,597 SNP markers of an interspecific F2 cross of two closely related Lake Victoria cichlids ( Paralabidochromis chilotes and Paralabidochromis sauvagei and contained 184 microsatellites and two SNP markers with a mean marker spacing of 6.09 cM on 25 linkage groups , namely LG 1 (XY), LG 3 (ZW), and LG 23 (XY)  and the anti M\u00fcllerian hormone (amh) might have been re-used as sex determination loci . The map was built using 1,597 SNPs identified and genotyped via restriction-site associated DNA (RAD) sequencing with an average marker distance of 1.01 cM. We then used the linkage map to anchor the scaffolds of the P. nyererei reference genome to the 22 linkage groups of the map and to perform a QTL analysis for putative sex determination loci in Pundamilia. We identify the LG determining sex in a Lake Victoria cichlid cross, as well as potential candidate genes for sex determination and put these findings into the context of sex determination evolution within a rapidly radiating clade of fish.In the present study we construct a linkage map of an interspecific F2 cross between two very closely related Lake Victoria cichlid species (Pundamilia sp. \u2018red head\u2019 (th or 5th lab generation) and a wild P. pundamilia female caught by OS at Makobe Island in Lake Victoria in 2003. Eggs were removed from the female\u2019s mouth five days after spawning and reared in isolation from the adults. After reaching maturity, four F1 individuals were crossed, resulting in two F2 families with together more than 300 individuals. When F2 individuals were adult and sexually mature sex was determined based on coloration, then sedated fish were killed with MS222 , and a fin clip was taken and stored in 98% ethanol for genetic analyses . Genomic DNA of 218 F2 progeny, the four F1 parents, and the two F0 grandparents was extracted using phenol-chloroform  each on a single lane of an Illumina HighSequation 2500 platform either at the Next Generation Sequencing Platform of the University of Bern or at the Genomic Technologies Facility of the University of Lausanne. Some individuals and all F0 grandparents were sequenced in up to three libraries to increase coverage. Together with each library, we sequenced about 10% reads of bacteriophage PhiX genomic DNA (Illumina Inc.) to increase complexity at the first 10 sequenced base pairs. During read processing, PhiX reads were further utilized to recalibrate libraries to equalize base quality scores across Illumina lanes utilizing GATK version 3.2  and filtered using FASTX Toolkit 0.0.13 (http://hannonlab.cshl.edu/fastx_toolkit/index.html) requiring a minimum quality of 10 at all bases and of 30 in at least 95% of the read. After PhiX removal, reads were demultiplexed, cleaned, and trimmed to 92 bp with process_radtags implemented in Stacks v1.26 (P. nyererei reference genome (https://github.com/jpuritz/dDocent/blob/master/scripts/dDocent_filters), genotypes were further excluded (thresholds given in brackets) on criteria related to allelic balance at heterozygote sites , quality vs. depth (ratio <0.5), strand presentation (overlapping forward and reverse reads), and site depth . Multi-allelic variants and indels were removed, resulting in 7,401 SNPs. Of the 7,401 filtered SNPs 2,052 were alternative homozygous in the grandparents, and were used to build the genetic linkage map.Before recalibration, read qualities were inspected using fastQC (e genome . Mapped P < 0.001) were excluded for linkage map reconstruction. Linkage groups were identified based on an independent logarithm of odds (LOD) threshold of 12. Unlinked markers were excluded. The strongest cross-link (SCL) in the final map is 5.4. The linkage map was built using the regression mapping algorithm, a recombination frequency smaller than 0.40, and an LOD larger than 3. Up to three rounds of marker positioning were conducted with a jump threshold of 5. A ripple was performed after the addition of each new marker. Map distances were calculated using the Kosambi mapping function. All markers resolved onto 22 linkage groups were matched to positions in the Oreochromis niloticus genome using a chain file  identified during mapping (see paragraph above). We ordered and oriented the scaffolds with ALLMAPS (Pundamilia nyererei reference (Pundamilia reference version 2.0). Chain files were produced with ALLMAPS and in the opposite direction using chainSwap from kentUtils (https://github.com/ENCODE-DCC/kentUtils). We could then use the chain file to liftover the position of all 7,401 genotyped loci, using Picard liftoverVcf (http://broadinstitute.github.io/picard/index.html). In addition, we generated a new version of the NCBI Pundamilia nyererei RefSeq annotation file with the positions for reference version 2.0 by lifting over the positions from the NCBI PunNye1.0 annotation release 101 (https://www.ncbi.nlm.nih.gov/genome/annotation_euk/Pundamilia_nyererei/101/#BuildInfo) using the UCSC liftOver tool  are deposited on short read archive SRA accession SRP136207. Supplemental material available at Figshare: https://doi.org/10.25387/g3.6221921.All genomic resources see , the genPundamilia linkage map, 1,182 markers could be positioned onto Oreochromis niloticus linkage groups (Ore-LG). The linkage map comprises 22 linkage groups containing 1,597 markers with an average marker distance of 1.01 cM adding up to a total map length of 1593.72 cM , Table 1Pundamilia linkage map provides a new chromosome framework for whole genome sequence assembly and map integration with more anchoring points then previous published maps. The anchored genome encompasses 78.7% of the total bases  of the original P. nyererei reference genome based on 383 anchored scaffolds, of which 233 are now oriented. This is a slightly higher fraction than in the Lake Malawi cichlid Metriaclima zebra, where 564,259,264 bp (66.5%) of the genome sequence could be anchored to linkage groups . We did not find any further associations on any of the other LGs. Ore-LG23 has been previously identified as one potential XY sex-determining LG in Oreochromis . This suggests that none of the markers used to build the linkage map are determining sex directly, but that the causal locus can be found close by and indicates that there are no further major genetic determiners of sex segregating in this cross. Investigating the segregation patterns in the larger of the F2 mapping-families (n = 122) more in detail revealed that the loci selected to build the map  and male (BB) and heterozygous in both F1 (AB)) segregate as expected in a 50:50 ratio of AA:AB in F2 females and AB:BB in F2 males . Among them is the anti-m\u00fcllerian hormone (amh), a master gene for sex determination in other fish. Amh is part of the transforming growth factor beta pathway, responsible for the regression of M\u00fcllerian ducts in tetrapods , a mutation in the receptor of the amh (amhrII) determines sex (amhy (Y chromosome-specific anti-m\u00fcllerian hormone) gene has been inserted upstream of amh in the cascade of male development in the neotropical silverside Odonthestes hatcheri  and in Astatotilapia calliptera on LG7 (gsdf) (Pundamilia Pun-LG10 (Ore-LG 23) acts as an (evolving) sex chromosome, even though it might not be the only region controlling sex in Pundamilia. The anti-m\u00fcllerian hormone amh (or a derived copy) appears to be a strong candidate influencing sexual development in Pundamilia, but further work is warranted to characterize the genomic candidate region and the impact of this candidate gene on sex determination.Within our mapping interval of \u223c1.9 Mb, 65 genes, based on the NCBI annotation for the new 7 (gsdf) . Our resamh, nor Pun-LG10 or a homologous region was invoked in sex determination in other Lake Victoria cichlids that have previously been used for mapping sex (A recent meta-analysis showed that transitions between sex determination systems are frequent across fish species, including transitions to and between heteromorphic sex chromosomes (ping sex , this ma"]}
{"representative": "In this paper, an application for the management, supervision and failure forecast of a ship\u2019s energy storage system is developed through a National Marine Electronics Association (NMEA) 2000 smart sensor network. Here, the NMEA 2000 network sensor devices for the measurement and supervision of the parameters inherent to energy storage and energy supply are reviewed. The importance of energy storage systems in ships, the causes and models of battery aging, types of failures, and predictive diagnosis techniques for valve-regulated lead-acid (VRLA) batteries used for assisted and safe navigation are discussed. In ships, battery banks are installed in chambers that normally do not have temperature regulation and therefore are significantly conditioned by the outside temperature. A specific method based on the analysis of the time-series data of random and seasonal factors is proposed for the comparative trend analyses of both the battery internal temperature and the battery installation chamber temperature. The objective is to apply predictive fault diagnosis to detect any undesirable increase in battery temperature using prior indicators of heat dissipation process failure\u2014to avoid the development of the most frequent and dangerous failure modes of VRLA batteries such as dry out and thermal runaway. It is concluded that these failure modes can be conveniently diagnosed by easily recognized patterns, obtained by performing comparative trend analyses to the variables measured onboard by NMEA sensors. Vessels are essentially floating complex systems, such as freighter ships, carrier ships, cruise ships, ship factories, oceanographic research ships, and battle ships, etc. All of these vessels are equipped with navigation, propulsion, power generation, distribution, and other systems of life support. For the control and supervision of such systems, the existence of common standards of communication networks would be desirable. As in other distributed control schemes, the transfer of data in ships is done with networks of low-level control, of real-time features, and of critical natures, with temporary response restrictions. They include less restrictive hierarchical networks not directly related to the safety of the ship, up to supervision, planning, and business management systems.Decision-making that affects the operation of the ship, involving safety, crew, passengers, cargo and the environment, is generally performed on the bridge or other control centers. To make decisions efficiently and carry them out requires access to many of the information systems on board. Systems of special relevance can include navigation, weather forecasting, power generation and storage, engines and machinery, data processing, messages and alarms, etc. The special risks involved in an aggressive environment such as marine navigation require adequate levels of security, availability, redundancy, and latency of communications networks. Although local office-type networks can work at the same speed, from the point of view of reliability they are unadvisable.A large number of sensors, controllers, electronic devices and systems must be installed on shipboard, and they generate a huge amount of data and information. Such information must be exchanged reliably to aid system integration and safe navigation ,2. TheseSpecifically, issues concerning power generation, status supervision, alarms, prognosis, and the control of devices such as generators, alternators, hybrid inverters, and shore-power, are tasks to be considered. In addition, electrical distribution tasks such as the delivery of power on vessels, identification of loads, load sharing, and virtual breakers are important issues.Ship navigation involves different critical operations where no uncertainty in decision making is acceptable. Such uncertainty can subject crew, passengers, cargo, or the ship itself to conditions of potential danger. A diagnosis of predictive failures is essential for a safe navigation. This diagnosis is based on the permanent analysis of the health condition of the system, through the detection and analysis of different symptoms that precede system\u2019s failures. This analysis can be done using time-series data of certain system parameters. These techniques for predictive diagnosis allow for generally adequate margins or reaction capacities in the application of predictive maintenance operations.In order to maintain a safe navigation, ships require that many systems are continuously available, i.e., navigation, communication, and weather forecast equipment. If a failure of the storage and power supply system affects the maneuvering system during a critical operation, the result can be a serious accident . TherefoIn ships, battery banks are installed in chambers that normally do not have temperature regulation and that are therefore significantly conditioned by the outside temperature. In this paper, a specific method based on the analysis of the time-series data of random and seasonal factors is proposed for the comparative trend analyses of the internal temperature of batteries and the battery installation chamber temperature. The objective is to apply a predictive fault diagnosis to detect any undesirable increase in battery temperature due to a prior heat dissipation process failure, to avoid the development of the most frequent and dangerous failure modes of VRLA batteries\u2014such as dry out and thermal runaway. It is concluded that these failure modes can be conveniently diagnosed by easily recognized patterns obtained by performing comparative trend analyses to the variables measured onboard by National Marine Electronics Association (NMEA) sensors.The advantage of the diagnostic method based on the comparative trend analyses proposed in this work is that it focuses on the assignable cause that precedes the dry out and thermal runaway failures, which is the loss of the operating capacity of the heat dissipation process of the battery banks. The heat dissipation process of battery banks in real navigation conditions does not have a specific nature. It depends on the characteristics of the installation chambers (which do not remain invariable in time), the materials used, the size of the heat dissipation areas, and the ventilation conditions, etc. All these factors affect the batteries in a variable way, depending on the type of batteries and their intrinsic aging conditions.In this study the operation and tests of the batteries have been made in real navigation conditions using a NMEA 2000 sensor network. As stated before, the possibility of using refrigerated chambers for battery installation is not feasible in most cases, nor from the economic point of view or from the energy consumption point of view.In Before the year 2000, some attempts of standardizing communication networks in ships were made. Various manufacturers developed different systems, however, differences in requirements made it difficult to find one common standard for the networks used in the different parts of the ship. IEC 61162-1 defines about 50 talker identifiers for individual types of navigation and radio communication equipment alone. In  approximWith regard to maritime navigation, a new standard for linear network communication\u2014NMEA 2000\u2014was presented in 2001 by the National Marine Electronics Association (NMEA) ,6. It waSome features of the data connection layer of the NMEA 2000, like in the physical layer, are determined by the choice of CAN as the main network. The NMEA 2000 fully makes use of the international standard of the ISO 11783-3 data connection layer, which is virtually identical to the SAE J1939-21 standard . Additional requirements contained in the NMEA 2000 ensured better copying, with special types of data and formats transmitted through a navigational device and supported by the special construction of such devices [In 2007 CANopen as IEEE P1551.6 was proposed as belonging to the IEEE 1451 family of Smart Transducer Interface Standards for sensors and actuators ,11. Part 1: IEC 61162-1 single talker and multiple listeners .Part 2: IEC 61162-2 single talker and multiple listeners, high-speed transmission.Part 3: IEC 61162-3 serial data instrument network .Part 450: IEC 61162-450 multiple talkers and multiple listeners\u2013Ethernet interconnection .Concurrently, taking in mind mainly big ships, the Working Group 6 (WG6) of Technical Committee 80 (TC80) of the IEC defined a set of IEC 61162 standards for \u201cDigital interfaces for navigational equipment within a ship\u201d, divided into four parts :Part 1: Subgroup TC80/WG6 specified the use of Ethernet for on-board navigation networks. The specification was limited to the transport of NMEA sentences subject to the definition made in 61162-1 on IPv4. Due to the low amount of complexity of the protocol, it was called Lightweight Ethernet (LWE), and was presented at the ISIS 2011 symposium .IEC 61162-460: 2015 (E) is a complement to the IEC 61162-450 standard, seeking the introduction of higher security standards, and improving network integrity. The first edition was published in 08/2015.Some of the first ship data network standards published were the US Navy\u2019s SAFENET (Survivable Adaptable Fiber optic Embedded Network) standards I and II  in 1988,In the period 1991\u20131993 a Norwegian research project, MITS (Maritime Information Technology Standard) was developed and subsequently, between 1993\u20131996 the MITS protocol was implemented on several ships, based on a single non-redundant Ethernet on the physical layer and TCP/IP protocols up to the transport layer ; howeverStandard redundancy support and fully redundant network system based on dual Ethernets and the IP protocols were specified in the project PISCIS (1998\u20132000), taken up and developed by the IEC 61162-400 series of standards .The new work item 80/506/NP on an Ethernet based interface standard was proposed in 2007 by Sweden to the IEC and accepted in March 2008. The IEC TC80/WG6 went to work on its development and the final version was published in April 2011 as IEC 61162-450 . This TC80/WG6 subgroup has specified with IEC 61162-450 and IEC 61162-460 standards the use of Ethernet and safety security conditions for shipboard navigational networks, taking into account the new developments in legislation that make it necessary to look closer at improved system integration tools such as data networks ,19.Other contributions in the context of IT standards were made through major integration projects such as Flagship, especially in the development of IEC 61162-450 and the final stages of ISO 28005 [Currently, there are projects such as Signal K, which has been proposed as a solution of the next generation for the exchange of marine data. It not only allows communication between instruments and sensors aboard a single ship, but also aims to share data among several ships, navigation aids, bridges, marinas and other land resources. It is designed to be easily used by web and mobile applications and to connect modern ships to the concept of the Internet of Things. It uses a \u201cSmart\u201d Gateway that converts existing NMEA data into Signal K, and its installation consists simply of wiring the gateway to NMEA0183 and/or NMEA 2000 networks and plugging the gateway into a wireless router [If properly designed, built, and maintained, a battery can provide many years of reliable service. A new battery might not initially provide 100% capacity. The capacity typically improves over the first few years of service, reaches a peak, and declines until the battery reaches its life limit. A reduction to 80% of the rated capacity is usually defined as the end of life for a lead-acid battery. Below 80%, the rate of battery deterioration accelerates, and it is more prone to sudden failure resulting from a mechanical shock or a high discharge rate. Note that even under ideal conditions, a battery is expected to eventually wear out . With the objective of maximum availability of the energy storage system, the storage capacity and the useful life of the batteries depends to a large extent on a suitable management of their use . OverloaThe dynamic behavior of battery operation has been studied by a large number of researchers . The modIn addition to these electrical models, other mathematical models have been developed to estimate the parametric variations depending on the values associated with the time of use/disuse and variations of the temperature of the battery . These mTo monitor the useful life of batteries, the aging phenomenon must be analyzed. Batteries age both when they are stationary  and when they are subjected to a cyclic operation (cycling ageing) . In the In practical terms, these effects translate into two repercussions: An increase in the internal resistance of the battery and a loss of capacity . Althougini) according to Equation (1).The most visible consequence of the aging of a battery is the gradual loss of its capacity, which is established through the parameter of the state of health of the battery (SOH). The SOH is calculated as the quotient between the current capacity (Cap) of the battery and the initial capacity Plate sulfationSoft and hard shortsPost leakageThermal runawayPositive-grid corrosionIt is known that batteries have different failure modes depending on their technology . Nowadayin, which in turn depends under normal conditions largely, but not exclusively, on the external temperature Tex due to weather conditions. The outside temperature, Tex, is \u201cfiltered\u201d by the battery installation chamber and becomes the ambient temperature Tamb.Some of the failure modes listed above, especially dry out, positive-grid corrosion and thermal runaway, are strongly dependent on the increase in the internal battery temperature Tin has a strong influence on aging, grid-corrosion rates, and rates of water loss (dry out) due to evaporation or hydrogen evolution at the negative plates (self-discharge), which all increase with increasing temperature. On the other hand, a (moderate) temperature increase may improve service life in applications involving severe cycling [T cycling . Dry out is a phenomenon that occurs and is accelerated due to excessive heat  and over-charging, which can cause elevated internal temperatures, high ambient  temperatures, and contributes decisively to grid corrosion. Up to 82\u201385% of the failures exhibit signs of dry out . It is oamb, the Vfloat current, and the ripple current effect. In turn, the causes of the increase in the internal temperature of the battery are the ambient temperature TThermal runaway is a condition in which the battery temperature increases rapidly resulting in extreme overheating of the battery, therefore the battery can melt, catch on fire, or even explode. Thermal runaway can only occur if the battery is at a high-ambient temperature and/or the charging voltage is set too high ,60. Althamb in different ways. Among diverse batteries of different make and model, there are significant differences in the float voltages that can cause different aging periods. The following factors contribute to the response variation in each battery behavior: Chemistry of the battery and construction, age of the battery, and especially chamber conditions where batteries are installed [Different batteries can be affected by the float voltage and the ambient temperature Tnstalled .If the process of heat generation produced internally in the battery reaches an advanced uncontrolled phase, violent boiling will occur together with a rapid generation of gas causing in turn over-pressurization, which if not detected in time can cause catastrophic damage due to emissions of hydrogen, oxygen, hydrogen sulfide gas (an irritant), and atomized electrolyte. This process can cause a fire or explosion in the installation chamber . In thisRipple current is another contributor for battery inner temperature increase. Battery manufacturers recommend that under normal float-charge conditions, battery ripple RMS (root mean square) voltage must be limited to <0.5% of the Direct Current (DC) voltage applied to the battery. This ensures that the instantaneous cell voltage will not fall below the open cell voltage or rise above the maximum float-charge voltage. It also eliminates the consequential battery heating that would occur from constantly cycling the battery through discharging and recharging states. Many early laboratory and real-world studies of lead acid (Pb) have shown that Alternating Current (AC) ripple may cause the cell to experience shallow discharge cycles, that in turn may lead to gassing, grid corrosion and internal heat generation ,64.It is well known that high temperature is the \u201ckiller\u201d of all batteries, and that its effect varies depending on the manufacturer and model or the type of technology used in its manufacture. Lead acid at 95 \u00b0F (35 \u00b0C) will experience a 50% shortened life, while Ni-Cd will have a 16%\u201318% shortening of life ,62. For At the other end, the low-temperature range slows down the internal chemical reactions in any battery. The degree of reduced performances vary according to the technology also. For example, at temperatures around freezing, a VRLA may need capacity compensation of 20%. The lead-calcium cell using 1.215 specific gravity acid will require a doubling of capacity, while the Ni-Cd will need about an 18% increased capacity. Under ideal conditions, the trend analysis of certain battery parameters, especially temperature, impedance, capacity, and SOH, would be an excellent tool to observe how the batteries degrade over time, and when a decision can be made to replace them. However, as mentioned above, easy access to all of these parameters is not always available ,66,67.In the data connection layer of the NMEA 2000 network, the main functions of the CAN interface are: Generating the linear stream of bits, controlling the access to the network, as well as the controlling of errors and automatic transmission of error messages.The CAN network is a linear, bit-orientated main. To avoid collisions and errors of transmission, the CSMA/CA method of the access to the main is applied, which determines that the reaction time of all drivers must be less than the transfer time of a bit .NMEA 2000 consequently inherited these limitations that initially conditioned its use in large vessels. Some of these limitations were the length of the main speed versus transmission speed; since all the CSMA/CA devices have to work with the same speed and in long lines, differences of a signal due to delays, may appear. Currently, this restriction can be solved by using NMEA 2000 network segments with devices such as network bus extenders (NBE) .NBE100 devices were developed to be able to extend the maximum node count up to 250, as well as the limit network trunk length and the cumulative drop length of a NMEA 2000 network. Without extenders a single network has a maximum of only nodes allowed, a network trunk length of 200 m, and a maximum cumulative drop length of 78 m.In 2001, NMEA published its NMEA 2000 standard and was also adopted as an IEC 61162-3 standard. More than 140 renowned companies belong to the manufacturer\u2019s list of NMEA 2000 developer members. NMEA 2000 has had a great penetration de facto in medium and small length vessels. Later in 2012, NMEA announced the project OneNet  to develThe structure of NMEA 2000 is shown in In the NMEA 2000 network, devices are available for the measurement, monitoring, supervision and data processing of parameters from the navigation system, as well as graphical displays for the analysis of short-term trends. There are also devices for the registration of such data, such as the Voyage Data Recorder (VDR). These devices are reviewed in the following sections. Maretron\u2019s DCM100  is a senBattery VoltageBattery CurrentRipple VoltageBattery Case TemperatureState of ChargeTime RemainingBattery CapacityBattery TypesCharging InefficienciesCharge Efficiency Factor (CEF)Discharging InefficienciesPeukert ExponentCharge Efficiency Factor CalculationIf \u201cBattery\u201d type is selected, many battery-related options become available , where dThe PB200 Weather-Station instrument is designed to output time series of data of weather parameters instantaneous values. Additionally, it is equipped with temperature and barometric pressure sensors that help to make trend analyses and forecasts on changing weather patterns . This wein [Maretron\u2019s TMP100 module measures the temperature for up to 6 temperature probes and reports the information over an NMEA 2000 network . The TMPin .The Vessel Data Recorder VDR100  is a kinAdditionally, this activity can be shown in the form of the time series of data of all the parameters that the DCM100 is able to monitor. In turn, the NMEA 2000 network has the ability to display on-line mobile windows of up to 1-week amplitude, and integrates the ability to perform treatment of alarms and emergencies. The N2KView software  or a MarMaretron\u2019s SMS100 short message service (Text) module is a mobile or cellular modem dedicated to sending alerts or alarm messages to selected phone numbers . This deTrend analysis is a quantitative technique that can be used to identify potentially hazardous conditions based on past empirical data obtained from time series of data. A trend analysis can reveal a movement toward unacceptable, undesirable, or dangerous reliability, safety, or levels of assurance. Its application dramatically decreases uncertainty and emergency replacements allowing to make adequate decisions for maintenance planning . In addiIn this work, a scenario under real weather conditions of navigation has been considered. This scenario is one in which a set of batteries are affected in terms of the dynamics of the temperature variable, by a set of numerical values associated with a time series of a stochastic process of seasonal character. t is the trend, St is the seasonal component, and It is the noise or random part.One way of describing time series is based on the idea of decomposing the variation of a series into several basic components, which becomes especially interesting when in the series a certain tendency or certain periodicity is observed . This deIn these conditions, a battery will experience changes associated with a dynamic in the form of random seasonal time series, that is, the temperature of the banks batteries will oscillate in successive diurnal warm-ups and nocturnal cooling, with higher average values in summer and lower in winter.The damage caused to a battery due to exposure to high temperatures is not reversible, even if subjected to a subsequent cooling. For example, the corrosion effect of the positive grid cannot be eliminated and occurs at all temperatures, which is simply a matter of the speed at which the corrosion process occurs. The only solution is to try to control and avoid as far as possible the causes involved in the increase of the temperature in batteries, with the criteria of economic profitability against the risks of failure .amb is made. From a general point of view, the method developed in this work is based on the performance of a comparative analysis of the behavior of the parameters presented in A difference introduced in the currently presented work is that the operation and tests of the batteries have been made in real navigation conditions, where the possibility of using refrigerated chambers for batteries installation is not feasible in most cases, from an economic point of view or from an energy consumption point of view.ex has on the dynamics of the internal temperature Tin of the batteries, and also on the tendency of the battery installation chamber\u2019s ambient temperature Tamb. Both show a behavior whose dynamics are associated with random seasonal time series, influenced by the external temperature Tex, as can be verified by a cross-correlation analysis between the lagged series.One of the first characteristics observed in the analysis of the series recorded in the tests is the important influence that the external temperature Tin increase is due to the superposition of a set of parameters that overlap their effects as heat sources that increase the internal temperature of the battery. Note that Tex whose source lies in the existing weather conditions. The second parameter is the ambient temperature Tamb, which results from the \u201cfiltering\u201d effect caused by the installation chamber on Tex. The third parameter is due to the contribution to the temperature increase produced by the ripple current (AC), whose source comes from the power electronics of the battery charger specifically associated to the aging of its components (diodes). The first parameter to consider is the external temperature Tfloat) contributes to the increase in temperature and the reduction of the internal impedance of the battery, which in turn causes the battery to accept even more current, that is able to trigger a process of thermal runaway instability after a previous and accelerated dry out process [The float input current  and battery installation chamber temperature (Tamb). The objective is to apply predictive fault diagnosis using early detection of the failure or loss of capacity of the battery heat dissipation process to prevent any undesirable increase in temperature, in order to avoid the development of failure modes such as dry out and thermal runaway. Taking into account that dry out is often a prior effect to other failure modes such as grid corrosion [This work focuses on proposing a specific method for the comparative trend analysis of the internal temperature of the batteries , the materials used, the size of the heat dissipation areas, and the ventilation conditions, etc., and that affects the batteries in a variable way depending on the type of batteries and their intrinsic aging state condition.in and Tamb is observed, it becomes a prior indicator that the battery is not being able to dissipate normally the heat generated inside. In other words, this first failure diagnosis of the heat dissipation process becomes a predictive indicator to avoid possible dry out and eventual thermal runaway failures.If an increasing divergence through an additional comparative trend analysis of both Tex are shown. In the dynamic behavior of the time series, it is easy to recognize their seasonal and random nature, especially in the case of the external temperature series. In both Figures, the temperatures of the battery banks are compared to the outside temperature, observing a follow-up with a certain time delay.The results of the parametric measurements made and their interpretation are shown in this section. in and external temperature Tex have certain differences in their appearance, mainly due to the higher frequency components of Text, while, Tin shape is smoothed. This is due to the large thermal inertia of the battery. It takes time for the battery to absorb temperature and it takes time for the battery to relinquish temperature. In addition, the daily cyclic behavior of all data series is completely evident.It should be realized that battery temperature Tex and the internal temperature Tin of the battery are correlated with a certain delay value, as affirmation of the working hypothesis.in temperature series of the three battery banks are shown, where maximum coincidence in the dynamic evolution of the house and engine banks exist, because in this case, they share the same installation chamber, while the bow thruster battery bank are installed in a different chamber in the bow vessel area. In all cases, it is evident that the thermal inertia and the enclosures of the installations act as smoothing filters of the battery inner temperature series, notably suppressing the high-frequency random component observed in the outdoor temperature series (Tex) in In The house battery bank presents in general an increase of temperature with respect to the engine battery bank and the bow thruster battery bank, which is justified by the fact that it normally supplies a permanent power consumption to electrical and electronic equipment. Requests for energy supply from the other two banks can be described as sporadic, compared to those made to the house battery bank.In In The peaks of energy demand (in green, in and Tamb temperatures of the house battery. In conditions of normal operation it is observed that the curve of the installation chamber temperature Tamb is lifted upwards from the curve of the internal temperature Tin of the house battery. This is explained by the activation of the heat dissipation process from the inside of the battery to the outside in the installation chamber, which increases Tamb. Later when the current demand stops, Tamb tends to overlap progressively with the internal temperature Tin.in and Tamb, with a high correlation index and with a barely significant delay between both curves.In in, the temperature of the battery installation chamber Tamb, the floating charge voltage of the battery Vfloat and the float current Ifloat. Under normal operating conditions, as shown in the laboratory test of in and Tamb temperature curves is significant, whereby the heat dissipation process of the battery bank is working adequately, taking into account the specific characteristics and conditions of the type of battery and the installation chamber.In in is lower than Tamb, and in curve. This results in the crossing of the curves and an increasing divergence between Tin and Tamb.Initially In this case, the progressive divergence of the two curves shows that the heat dissipation process capacity is being exceeded and, if this condition persists, the development of the dry out phenomenon and eventually the thermal runaway occurrence is predictable.For safe maritime navigation, having a monitoring system based on observing the actual condition of use and specific technical characteristics of the ship\u2019s energy storage system is especially important and critical. The NMEA 2000 network\u2014together with intelligent sensor devices for battery monitoring, temperature measurements, ship data logging, and associated software developed for data processing\u2014allows for obtaining time series of data and for the application of trend analysis for better management of alarms, in order to face the appearance of incipient and/or sudden failures.The predictive diagnostic method proposed in this study does not depend on a temperature threshold value, but on the previous failure of the heat dissipation process. This behavior demonstrates that the working hypothesis proposed in the comparative trend analysis can be used as a recognition pattern for the predictive diagnosis of eventual dry out and thermal runaway failures.In the opinion of the authors, the equipment that is usually installed for the supervision of battery banks in navigation applications offers sufficient information on the most important parameters of battery operation. However, from the point of view of the implementation of predictive diagnostic techniques, the information they offer is not always easy to analyze by potential users who are largely not experts in the field, and much of its information potential is lost.For truly useful decision making in critical situations, it would be desirable that the information is oriented toward the mode of failure and displayed with multi-parametric high level integration. In that way, comparative trend analyses and correlation of the involved parameters could be applied. Even more, this information should be given in the form of patterns of immediate or easy recognition, that reliably allow the detection of an assignable cause such as a failure of the heat dissipation process of the battery, useful for predictive dry out and thermal runaway fault diagnosis. It is concluded that these failure modes can be conveniently diagnosed by easy recognized patterns obtained performing comparative trend analysis to the variables measured onboard.", "texts": ["In this paper, an application for the management, supervision and failure forecast of a ship\u2019s energy storage system is developed through a National Marine Electronics Association (NMEA) 2000 smart sensor network. Here, the NMEA 2000 network sensor devices for the measurement and supervision of the parameters inherent to energy storage and energy supply are reviewed. The importance of energy storage systems in ships, the causes and models of battery aging, types of failures, and predictive diagnosis techniques for valve-regulated lead-acid (VRLA) batteries used for assisted and safe navigation are discussed. In ships, battery banks are installed in chambers that normally do not have temperature regulation and therefore are significantly conditioned by the outside temperature. A specific method based on the analysis of the time-series data of random and seasonal factors is proposed for the comparative trend analyses of both the battery internal temperature and the battery installation chamber temperature. The objective is to apply predictive fault diagnosis to detect any undesirable increase in battery temperature using prior indicators of heat dissipation process failure\u2014to avoid the development of the most frequent and dangerous failure modes of VRLA batteries such as dry out and thermal runaway. It is concluded that these failure modes can be conveniently diagnosed by easily recognized patterns, obtained by performing comparative trend analyses to the variables measured onboard by NMEA sensors. Vessels are essentially floating complex systems, such as freighter ships, carrier ships, cruise ships, ship factories, oceanographic research ships, and battle ships, etc. All of these vessels are equipped with navigation, propulsion, power generation, distribution, and other systems of life support. For the control and supervision of such systems, the existence of common standards of communication networks would be desirable. As in other distributed control schemes, the transfer of data in ships is done with networks of low-level control, of real-time features, and of critical natures, with temporary response restrictions. They include less restrictive hierarchical networks not directly related to the safety of the ship, up to supervision, planning, and business management systems.Decision-making that affects the operation of the ship, involving safety, crew, passengers, cargo and the environment, is generally performed on the bridge or other control centers. To make decisions efficiently and carry them out requires access to many of the information systems on board. Systems of special relevance can include navigation, weather forecasting, power generation and storage, engines and machinery, data processing, messages and alarms, etc. The special risks involved in an aggressive environment such as marine navigation require adequate levels of security, availability, redundancy, and latency of communications networks. Although local office-type networks can work at the same speed, from the point of view of reliability they are unadvisable.A large number of sensors, controllers, electronic devices and systems must be installed on shipboard, and they generate a huge amount of data and information. Such information must be exchanged reliably to aid system integration and safe navigation ,2. TheseSpecifically, issues concerning power generation, status supervision, alarms, prognosis, and the control of devices such as generators, alternators, hybrid inverters, and shore-power, are tasks to be considered. In addition, electrical distribution tasks such as the delivery of power on vessels, identification of loads, load sharing, and virtual breakers are important issues.Ship navigation involves different critical operations where no uncertainty in decision making is acceptable. Such uncertainty can subject crew, passengers, cargo, or the ship itself to conditions of potential danger. A diagnosis of predictive failures is essential for a safe navigation. This diagnosis is based on the permanent analysis of the health condition of the system, through the detection and analysis of different symptoms that precede system\u2019s failures. This analysis can be done using time-series data of certain system parameters. These techniques for predictive diagnosis allow for generally adequate margins or reaction capacities in the application of predictive maintenance operations.In order to maintain a safe navigation, ships require that many systems are continuously available, i.e., navigation, communication, and weather forecast equipment. If a failure of the storage and power supply system affects the maneuvering system during a critical operation, the result can be a serious accident . TherefoIn ships, battery banks are installed in chambers that normally do not have temperature regulation and that are therefore significantly conditioned by the outside temperature. In this paper, a specific method based on the analysis of the time-series data of random and seasonal factors is proposed for the comparative trend analyses of the internal temperature of batteries and the battery installation chamber temperature. The objective is to apply a predictive fault diagnosis to detect any undesirable increase in battery temperature due to a prior heat dissipation process failure, to avoid the development of the most frequent and dangerous failure modes of VRLA batteries\u2014such as dry out and thermal runaway. It is concluded that these failure modes can be conveniently diagnosed by easily recognized patterns obtained by performing comparative trend analyses to the variables measured onboard by National Marine Electronics Association (NMEA) sensors.The advantage of the diagnostic method based on the comparative trend analyses proposed in this work is that it focuses on the assignable cause that precedes the dry out and thermal runaway failures, which is the loss of the operating capacity of the heat dissipation process of the battery banks. The heat dissipation process of battery banks in real navigation conditions does not have a specific nature. It depends on the characteristics of the installation chambers (which do not remain invariable in time), the materials used, the size of the heat dissipation areas, and the ventilation conditions, etc. All these factors affect the batteries in a variable way, depending on the type of batteries and their intrinsic aging conditions.In this study the operation and tests of the batteries have been made in real navigation conditions using a NMEA 2000 sensor network. As stated before, the possibility of using refrigerated chambers for battery installation is not feasible in most cases, nor from the economic point of view or from the energy consumption point of view.In Before the year 2000, some attempts of standardizing communication networks in ships were made. Various manufacturers developed different systems, however, differences in requirements made it difficult to find one common standard for the networks used in the different parts of the ship. IEC 61162-1 defines about 50 talker identifiers for individual types of navigation and radio communication equipment alone. In  approximWith regard to maritime navigation, a new standard for linear network communication\u2014NMEA 2000\u2014was presented in 2001 by the National Marine Electronics Association (NMEA) ,6. It waSome features of the data connection layer of the NMEA 2000, like in the physical layer, are determined by the choice of CAN as the main network. The NMEA 2000 fully makes use of the international standard of the ISO 11783-3 data connection layer, which is virtually identical to the SAE J1939-21 standard . Additional requirements contained in the NMEA 2000 ensured better copying, with special types of data and formats transmitted through a navigational device and supported by the special construction of such devices [In 2007 CANopen as IEEE P1551.6 was proposed as belonging to the IEEE 1451 family of Smart Transducer Interface Standards for sensors and actuators ,11. Part 1: IEC 61162-1 single talker and multiple listeners .Part 2: IEC 61162-2 single talker and multiple listeners, high-speed transmission.Part 3: IEC 61162-3 serial data instrument network .Part 450: IEC 61162-450 multiple talkers and multiple listeners\u2013Ethernet interconnection .Concurrently, taking in mind mainly big ships, the Working Group 6 (WG6) of Technical Committee 80 (TC80) of the IEC defined a set of IEC 61162 standards for \u201cDigital interfaces for navigational equipment within a ship\u201d, divided into four parts :Part 1: Subgroup TC80/WG6 specified the use of Ethernet for on-board navigation networks. The specification was limited to the transport of NMEA sentences subject to the definition made in 61162-1 on IPv4. Due to the low amount of complexity of the protocol, it was called Lightweight Ethernet (LWE), and was presented at the ISIS 2011 symposium .IEC 61162-460: 2015 (E) is a complement to the IEC 61162-450 standard, seeking the introduction of higher security standards, and improving network integrity. The first edition was published in 08/2015.Some of the first ship data network standards published were the US Navy\u2019s SAFENET (Survivable Adaptable Fiber optic Embedded Network) standards I and II  in 1988,In the period 1991\u20131993 a Norwegian research project, MITS (Maritime Information Technology Standard) was developed and subsequently, between 1993\u20131996 the MITS protocol was implemented on several ships, based on a single non-redundant Ethernet on the physical layer and TCP/IP protocols up to the transport layer ; howeverStandard redundancy support and fully redundant network system based on dual Ethernets and the IP protocols were specified in the project PISCIS (1998\u20132000), taken up and developed by the IEC 61162-400 series of standards .The new work item 80/506/NP on an Ethernet based interface standard was proposed in 2007 by Sweden to the IEC and accepted in March 2008. The IEC TC80/WG6 went to work on its development and the final version was published in April 2011 as IEC 61162-450 . This TC80/WG6 subgroup has specified with IEC 61162-450 and IEC 61162-460 standards the use of Ethernet and safety security conditions for shipboard navigational networks, taking into account the new developments in legislation that make it necessary to look closer at improved system integration tools such as data networks ,19.Other contributions in the context of IT standards were made through major integration projects such as Flagship, especially in the development of IEC 61162-450 and the final stages of ISO 28005 [Currently, there are projects such as Signal K, which has been proposed as a solution of the next generation for the exchange of marine data. It not only allows communication between instruments and sensors aboard a single ship, but also aims to share data among several ships, navigation aids, bridges, marinas and other land resources. It is designed to be easily used by web and mobile applications and to connect modern ships to the concept of the Internet of Things. It uses a \u201cSmart\u201d Gateway that converts existing NMEA data into Signal K, and its installation consists simply of wiring the gateway to NMEA0183 and/or NMEA 2000 networks and plugging the gateway into a wireless router [If properly designed, built, and maintained, a battery can provide many years of reliable service. A new battery might not initially provide 100% capacity. The capacity typically improves over the first few years of service, reaches a peak, and declines until the battery reaches its life limit. A reduction to 80% of the rated capacity is usually defined as the end of life for a lead-acid battery. Below 80%, the rate of battery deterioration accelerates, and it is more prone to sudden failure resulting from a mechanical shock or a high discharge rate. Note that even under ideal conditions, a battery is expected to eventually wear out . With the objective of maximum availability of the energy storage system, the storage capacity and the useful life of the batteries depends to a large extent on a suitable management of their use . OverloaThe dynamic behavior of battery operation has been studied by a large number of researchers . The modIn addition to these electrical models, other mathematical models have been developed to estimate the parametric variations depending on the values associated with the time of use/disuse and variations of the temperature of the battery . These mTo monitor the useful life of batteries, the aging phenomenon must be analyzed. Batteries age both when they are stationary  and when they are subjected to a cyclic operation (cycling ageing) . In the In practical terms, these effects translate into two repercussions: An increase in the internal resistance of the battery and a loss of capacity . Althougini) according to Equation (1).The most visible consequence of the aging of a battery is the gradual loss of its capacity, which is established through the parameter of the state of health of the battery (SOH). The SOH is calculated as the quotient between the current capacity (Cap) of the battery and the initial capacity Plate sulfationSoft and hard shortsPost leakageThermal runawayPositive-grid corrosionIt is known that batteries have different failure modes depending on their technology . Nowadayin, which in turn depends under normal conditions largely, but not exclusively, on the external temperature Tex due to weather conditions. The outside temperature, Tex, is \u201cfiltered\u201d by the battery installation chamber and becomes the ambient temperature Tamb.Some of the failure modes listed above, especially dry out, positive-grid corrosion and thermal runaway, are strongly dependent on the increase in the internal battery temperature Tin has a strong influence on aging, grid-corrosion rates, and rates of water loss (dry out) due to evaporation or hydrogen evolution at the negative plates (self-discharge), which all increase with increasing temperature. On the other hand, a (moderate) temperature increase may improve service life in applications involving severe cycling [T cycling . Dry out is a phenomenon that occurs and is accelerated due to excessive heat  and over-charging, which can cause elevated internal temperatures, high ambient  temperatures, and contributes decisively to grid corrosion. Up to 82\u201385% of the failures exhibit signs of dry out . It is oamb, the Vfloat current, and the ripple current effect. In turn, the causes of the increase in the internal temperature of the battery are the ambient temperature TThermal runaway is a condition in which the battery temperature increases rapidly resulting in extreme overheating of the battery, therefore the battery can melt, catch on fire, or even explode. Thermal runaway can only occur if the battery is at a high-ambient temperature and/or the charging voltage is set too high ,60. Althamb in different ways. Among diverse batteries of different make and model, there are significant differences in the float voltages that can cause different aging periods. The following factors contribute to the response variation in each battery behavior: Chemistry of the battery and construction, age of the battery, and especially chamber conditions where batteries are installed [Different batteries can be affected by the float voltage and the ambient temperature Tnstalled .If the process of heat generation produced internally in the battery reaches an advanced uncontrolled phase, violent boiling will occur together with a rapid generation of gas causing in turn over-pressurization, which if not detected in time can cause catastrophic damage due to emissions of hydrogen, oxygen, hydrogen sulfide gas (an irritant), and atomized electrolyte. This process can cause a fire or explosion in the installation chamber . In thisRipple current is another contributor for battery inner temperature increase. Battery manufacturers recommend that under normal float-charge conditions, battery ripple RMS (root mean square) voltage must be limited to <0.5% of the Direct Current (DC) voltage applied to the battery. This ensures that the instantaneous cell voltage will not fall below the open cell voltage or rise above the maximum float-charge voltage. It also eliminates the consequential battery heating that would occur from constantly cycling the battery through discharging and recharging states. Many early laboratory and real-world studies of lead acid (Pb) have shown that Alternating Current (AC) ripple may cause the cell to experience shallow discharge cycles, that in turn may lead to gassing, grid corrosion and internal heat generation ,64.It is well known that high temperature is the \u201ckiller\u201d of all batteries, and that its effect varies depending on the manufacturer and model or the type of technology used in its manufacture. Lead acid at 95 \u00b0F (35 \u00b0C) will experience a 50% shortened life, while Ni-Cd will have a 16%\u201318% shortening of life ,62. For At the other end, the low-temperature range slows down the internal chemical reactions in any battery. The degree of reduced performances vary according to the technology also. For example, at temperatures around freezing, a VRLA may need capacity compensation of 20%. The lead-calcium cell using 1.215 specific gravity acid will require a doubling of capacity, while the Ni-Cd will need about an 18% increased capacity. Under ideal conditions, the trend analysis of certain battery parameters, especially temperature, impedance, capacity, and SOH, would be an excellent tool to observe how the batteries degrade over time, and when a decision can be made to replace them. However, as mentioned above, easy access to all of these parameters is not always available ,66,67.In the data connection layer of the NMEA 2000 network, the main functions of the CAN interface are: Generating the linear stream of bits, controlling the access to the network, as well as the controlling of errors and automatic transmission of error messages.The CAN network is a linear, bit-orientated main. To avoid collisions and errors of transmission, the CSMA/CA method of the access to the main is applied, which determines that the reaction time of all drivers must be less than the transfer time of a bit .NMEA 2000 consequently inherited these limitations that initially conditioned its use in large vessels. Some of these limitations were the length of the main speed versus transmission speed; since all the CSMA/CA devices have to work with the same speed and in long lines, differences of a signal due to delays, may appear. Currently, this restriction can be solved by using NMEA 2000 network segments with devices such as network bus extenders (NBE) .NBE100 devices were developed to be able to extend the maximum node count up to 250, as well as the limit network trunk length and the cumulative drop length of a NMEA 2000 network. Without extenders a single network has a maximum of only nodes allowed, a network trunk length of 200 m, and a maximum cumulative drop length of 78 m.In 2001, NMEA published its NMEA 2000 standard and was also adopted as an IEC 61162-3 standard. More than 140 renowned companies belong to the manufacturer\u2019s list of NMEA 2000 developer members. NMEA 2000 has had a great penetration de facto in medium and small length vessels. Later in 2012, NMEA announced the project OneNet  to develThe structure of NMEA 2000 is shown in In the NMEA 2000 network, devices are available for the measurement, monitoring, supervision and data processing of parameters from the navigation system, as well as graphical displays for the analysis of short-term trends. There are also devices for the registration of such data, such as the Voyage Data Recorder (VDR). These devices are reviewed in the following sections. Maretron\u2019s DCM100  is a senBattery VoltageBattery CurrentRipple VoltageBattery Case TemperatureState of ChargeTime RemainingBattery CapacityBattery TypesCharging InefficienciesCharge Efficiency Factor (CEF)Discharging InefficienciesPeukert ExponentCharge Efficiency Factor CalculationIf \u201cBattery\u201d type is selected, many battery-related options become available , where dThe PB200 Weather-Station instrument is designed to output time series of data of weather parameters instantaneous values. Additionally, it is equipped with temperature and barometric pressure sensors that help to make trend analyses and forecasts on changing weather patterns . This wein [Maretron\u2019s TMP100 module measures the temperature for up to 6 temperature probes and reports the information over an NMEA 2000 network . The TMPin .The Vessel Data Recorder VDR100  is a kinAdditionally, this activity can be shown in the form of the time series of data of all the parameters that the DCM100 is able to monitor. In turn, the NMEA 2000 network has the ability to display on-line mobile windows of up to 1-week amplitude, and integrates the ability to perform treatment of alarms and emergencies. The N2KView software  or a MarMaretron\u2019s SMS100 short message service (Text) module is a mobile or cellular modem dedicated to sending alerts or alarm messages to selected phone numbers . This deTrend analysis is a quantitative technique that can be used to identify potentially hazardous conditions based on past empirical data obtained from time series of data. A trend analysis can reveal a movement toward unacceptable, undesirable, or dangerous reliability, safety, or levels of assurance. Its application dramatically decreases uncertainty and emergency replacements allowing to make adequate decisions for maintenance planning . In addiIn this work, a scenario under real weather conditions of navigation has been considered. This scenario is one in which a set of batteries are affected in terms of the dynamics of the temperature variable, by a set of numerical values associated with a time series of a stochastic process of seasonal character. t is the trend, St is the seasonal component, and It is the noise or random part.One way of describing time series is based on the idea of decomposing the variation of a series into several basic components, which becomes especially interesting when in the series a certain tendency or certain periodicity is observed . This deIn these conditions, a battery will experience changes associated with a dynamic in the form of random seasonal time series, that is, the temperature of the banks batteries will oscillate in successive diurnal warm-ups and nocturnal cooling, with higher average values in summer and lower in winter.The damage caused to a battery due to exposure to high temperatures is not reversible, even if subjected to a subsequent cooling. For example, the corrosion effect of the positive grid cannot be eliminated and occurs at all temperatures, which is simply a matter of the speed at which the corrosion process occurs. The only solution is to try to control and avoid as far as possible the causes involved in the increase of the temperature in batteries, with the criteria of economic profitability against the risks of failure .amb is made. From a general point of view, the method developed in this work is based on the performance of a comparative analysis of the behavior of the parameters presented in A difference introduced in the currently presented work is that the operation and tests of the batteries have been made in real navigation conditions, where the possibility of using refrigerated chambers for batteries installation is not feasible in most cases, from an economic point of view or from an energy consumption point of view.ex has on the dynamics of the internal temperature Tin of the batteries, and also on the tendency of the battery installation chamber\u2019s ambient temperature Tamb. Both show a behavior whose dynamics are associated with random seasonal time series, influenced by the external temperature Tex, as can be verified by a cross-correlation analysis between the lagged series.One of the first characteristics observed in the analysis of the series recorded in the tests is the important influence that the external temperature Tin increase is due to the superposition of a set of parameters that overlap their effects as heat sources that increase the internal temperature of the battery. Note that Tex whose source lies in the existing weather conditions. The second parameter is the ambient temperature Tamb, which results from the \u201cfiltering\u201d effect caused by the installation chamber on Tex. The third parameter is due to the contribution to the temperature increase produced by the ripple current (AC), whose source comes from the power electronics of the battery charger specifically associated to the aging of its components (diodes). The first parameter to consider is the external temperature Tfloat) contributes to the increase in temperature and the reduction of the internal impedance of the battery, which in turn causes the battery to accept even more current, that is able to trigger a process of thermal runaway instability after a previous and accelerated dry out process [The float input current  and battery installation chamber temperature (Tamb). The objective is to apply predictive fault diagnosis using early detection of the failure or loss of capacity of the battery heat dissipation process to prevent any undesirable increase in temperature, in order to avoid the development of failure modes such as dry out and thermal runaway. Taking into account that dry out is often a prior effect to other failure modes such as grid corrosion [This work focuses on proposing a specific method for the comparative trend analysis of the internal temperature of the batteries , the materials used, the size of the heat dissipation areas, and the ventilation conditions, etc., and that affects the batteries in a variable way depending on the type of batteries and their intrinsic aging state condition.in and Tamb is observed, it becomes a prior indicator that the battery is not being able to dissipate normally the heat generated inside. In other words, this first failure diagnosis of the heat dissipation process becomes a predictive indicator to avoid possible dry out and eventual thermal runaway failures.If an increasing divergence through an additional comparative trend analysis of both Tex are shown. In the dynamic behavior of the time series, it is easy to recognize their seasonal and random nature, especially in the case of the external temperature series. In both Figures, the temperatures of the battery banks are compared to the outside temperature, observing a follow-up with a certain time delay.The results of the parametric measurements made and their interpretation are shown in this section. in and external temperature Tex have certain differences in their appearance, mainly due to the higher frequency components of Text, while, Tin shape is smoothed. This is due to the large thermal inertia of the battery. It takes time for the battery to absorb temperature and it takes time for the battery to relinquish temperature. In addition, the daily cyclic behavior of all data series is completely evident.It should be realized that battery temperature Tex and the internal temperature Tin of the battery are correlated with a certain delay value, as affirmation of the working hypothesis.in temperature series of the three battery banks are shown, where maximum coincidence in the dynamic evolution of the house and engine banks exist, because in this case, they share the same installation chamber, while the bow thruster battery bank are installed in a different chamber in the bow vessel area. In all cases, it is evident that the thermal inertia and the enclosures of the installations act as smoothing filters of the battery inner temperature series, notably suppressing the high-frequency random component observed in the outdoor temperature series (Tex) in In The house battery bank presents in general an increase of temperature with respect to the engine battery bank and the bow thruster battery bank, which is justified by the fact that it normally supplies a permanent power consumption to electrical and electronic equipment. Requests for energy supply from the other two banks can be described as sporadic, compared to those made to the house battery bank.In In The peaks of energy demand (in green, in and Tamb temperatures of the house battery. In conditions of normal operation it is observed that the curve of the installation chamber temperature Tamb is lifted upwards from the curve of the internal temperature Tin of the house battery. This is explained by the activation of the heat dissipation process from the inside of the battery to the outside in the installation chamber, which increases Tamb. Later when the current demand stops, Tamb tends to overlap progressively with the internal temperature Tin.in and Tamb, with a high correlation index and with a barely significant delay between both curves.In in, the temperature of the battery installation chamber Tamb, the floating charge voltage of the battery Vfloat and the float current Ifloat. Under normal operating conditions, as shown in the laboratory test of in and Tamb temperature curves is significant, whereby the heat dissipation process of the battery bank is working adequately, taking into account the specific characteristics and conditions of the type of battery and the installation chamber.In in is lower than Tamb, and in curve. This results in the crossing of the curves and an increasing divergence between Tin and Tamb.Initially In this case, the progressive divergence of the two curves shows that the heat dissipation process capacity is being exceeded and, if this condition persists, the development of the dry out phenomenon and eventually the thermal runaway occurrence is predictable.For safe maritime navigation, having a monitoring system based on observing the actual condition of use and specific technical characteristics of the ship\u2019s energy storage system is especially important and critical. The NMEA 2000 network\u2014together with intelligent sensor devices for battery monitoring, temperature measurements, ship data logging, and associated software developed for data processing\u2014allows for obtaining time series of data and for the application of trend analysis for better management of alarms, in order to face the appearance of incipient and/or sudden failures.The predictive diagnostic method proposed in this study does not depend on a temperature threshold value, but on the previous failure of the heat dissipation process. This behavior demonstrates that the working hypothesis proposed in the comparative trend analysis can be used as a recognition pattern for the predictive diagnosis of eventual dry out and thermal runaway failures.In the opinion of the authors, the equipment that is usually installed for the supervision of battery banks in navigation applications offers sufficient information on the most important parameters of battery operation. However, from the point of view of the implementation of predictive diagnostic techniques, the information they offer is not always easy to analyze by potential users who are largely not experts in the field, and much of its information potential is lost.For truly useful decision making in critical situations, it would be desirable that the information is oriented toward the mode of failure and displayed with multi-parametric high level integration. In that way, comparative trend analyses and correlation of the involved parameters could be applied. Even more, this information should be given in the form of patterns of immediate or easy recognition, that reliably allow the detection of an assignable cause such as a failure of the heat dissipation process of the battery, useful for predictive dry out and thermal runaway fault diagnosis. It is concluded that these failure modes can be conveniently diagnosed by easy recognized patterns obtained performing comparative trend analysis to the variables measured onboard."]}
{"representative": "Vs) has advanced our understanding of their pharmacology. Herein, we report the purification and characterization of a novel non-selective mammalian and bacterial NaVs toxin, JZTx-14, from the venom of the spider Chilobrachys jingzhao. This toxin potently inhibited the peak currents of mammalian NaV1.2\u20131.8 channels and the bacterial NaChBac channel with low IC50 values (<1 \u00b5M), and it mainly inhibited the fast inactivation of the NaV1.9 channel. Analysis of NaV1.5/NaV1.9 chimeric channel showed that the NaV1.5 domain II S3\u20134 loop is involved in toxin association. Kinetics data obtained from studying toxin\u2013NaV1.2 channel interaction showed that JZTx-14 was a gating modifier that possibly trapped the channel in resting state; however, it differed from site 4 toxin HNTx-III by irreversibly blocking NaV currents and showing state-independent binding with the channel. JZTx-14 might stably bind to a conserved toxin pocket deep within the NaV1.2\u20131.8 domain II voltage sensor regardless of channel conformation change, and its effect on NaVs requires the toxin to trap the S3\u20134 loop in its resting state. For the NaChBac channel, JZTx-14 positively shifted its conductance-voltage (G\u2013V) and steady-state inactivation relationships. An alanine scan analysis of the NaChBac S3\u20134 loop revealed that the 108th phenylalanine (F108) was the key residue determining the JZTx-14\u2013NaChBac interaction. In summary, this study provided JZTx-14 with potent but promiscuous inhibitory activity on both the ancestor bacterial NaVs and the highly evolved descendant mammalian NaVs, and it is a useful probe to understand the pharmacology of NaVs.Exploring the interaction of ligands with voltage-gated sodium channels (Na V) is composed of a pore-forming alpha subunit and one or two covalently or non-covalently associated beta subunits. The alpha subunit has a topological structure of 24 transmembrane segments (TMs), which could be further divided into four homologous domains, with each domain containing six TMs. A total of nine NaV subtypes have been identified in mammals with different tissue distributions and accordingly diverse functions: the NaV1.1\u20131.3 subtypes that are mainly located in the central nervous system (CNS); the NaV1.4\u20131.5 subtypes that are expressed in the skeletal muscle cells and the cardiac myocyte cells, respectively; the NaV1.7\u20131.9 subtypes that are mostly restricted to the peripheral nervous system (PNS); and the NaV1.6 channel, which is expressed in both the CNS and the PNS [Vs were expressed in non-excitable cells such as astrocytes, microglia, macrophages, and cancer cells, and functioned in a non-canonical way [+ selectivity mechanism of mammalian NaVs are yet to be explored, and the milestone progresses regarding the cryo-EM structures of eukaryotic NaVs such as cockroach NaVPas [V1.4 [V1.4 [Vs, and are rich mines for developing drugs for treating NaV-related diseases and discovering probes for NaV researches [Vs; among these, site 1, site 3, site 4, and site 6 are binding sites for small disulfide-rich peptides from animal venoms [V1.2\u20131.8 channels, it is difficult to purify NaV subtype-specific modulators from animal venoms. This is because that these toxins might bind to NaVs by recognizing a common structure in them, which is similar to that of tetrodotoxin (TTX) occluding the pore of TTX-sensitive NaVs  by recognizing the conserved structures in them [V subtypes with comparable affinity are rare, as there are substantial differences between them. Furthermore, NaV voltage sensor binding peptide toxins (site 3 and site 4 toxins) have always shown reversible and state-dependent binding property. The identification of toxins deviating from these rules would advance our understanding of the pharmacology of NaV channels.The mammalian voltage-gated sodium channel  template for designing drugs targeting human NaVs [Vs, relatively few peptide toxins acting on bacterial NaVs have been reported. Mammalian Naell line . Since tian NaVs ,16. Thisreported ,21,22,23ic level . The cryevel [Vs . Further in them ,27. In toflurane ,28. Addiman NaVs . HoweverChilobrachys jingzhao, is purified and characterized. It showed promiscuous inhibitory activity on mammalian NaV1.2\u20131.8 channels and the bacterial NaChBac channel, and also inhibited the fast inactivation of the NaV1.9 channel. Kinetics data and mutation analysis proved that JZTx-14 was a gating modifier of both mammalian and bacterial NaVs. However, its irreversible blocking effect on mammalian NaV and its state-independent binding with the channel suggested that the action mode of JZTx-14 might be different from those classical site 4 toxins: that is, JZTx-14 might stably bind to a conserved toxin pocket deep within the NaV1.2\u20131.8 voltage sensor regardless of channel conformation change, however, its inhibitory effect on NaVs requires the toxin to trap the S3\u20134 loop in its resting state. This study provided a novel toxin to understand the pharmacology of both the mammalian and bacterial NaVs.In the present study, a novel peptide toxin, JZTx-14, from the venom of the spider C. jingzhao, JZTx-14, which non-selectively and potently inhibited NaV1.2\u20131.8 currents. This toxin had a retention time of 40.8 min in the RP-HPLC purification of the venom  (https://blast.ncbi.nlm.nih.gov/Blast.cgi) matched the toxins JZTx-14 and Jingzhaotoxin F4-32.60 (Chilobrachys jingzhao matched JZTx-14 with the highest score (UniProtKB/Swiss-Prot accession number: B1P1C0.1), with an identification coverage ratio of 100%. 1-C2-C3C4-C5-C6), and the mode of the disulfide bonds might be C1-C4, C2-C5, and C3-C6 (the number indicates the relative position of cysteine in the sequence). Sequence alignment showed that JZTx-14 had low identity with the peptide toxins in the database  C. AdditiF4-32.60 D. JingzhF4-32.60 D. We anadatabase F.Vs NaV1.2\u20131.9 heterologously expressed in HEK293T or ND7/23 cells. The NaV1.8 and NaV1.9 channels were chimeras, as described in our previous studies [V1.2\u20131.7 currents , 426.3 \u00b1 48.8 nM for NaV1.3 (n = 5), 290.1 \u00b1 23.2 nM for NaV1.4 (n = 6), 478.0 \u00b1 32.0 nM for NaV1.5 (n = 5), 158.6 \u00b1 29.4 nM for NaV1.6 (n = 4), 188.9 \u00b1 46.3 nM for NaV1.7 (n = 6), and 824.0 \u00b1 68.7 nM for NaV1.8 (n = 5)  S3\u20134 loop with that of NaV1.9, and tested its response to JZTx-14. The data showed that 2 \u00b5M toxin only slightly inhibited its peak currents, but profoundly slowed its fast inactivation ; all of these mutants showed no significant change of their sensitivity to JZTx-14, and an alanine scan mutation analysis of the DII S3b\u2013S4 paddle motif (from the 795th glutamine to the 808th arginine) did not identify any key site (data not shown). We propose that JZTx-14 associated with the DII S3\u20134 loops of NaV1.2\u20131.8 by binding multiple amino acids in this region. It well explained the targets proximity of JZTx-14 among NaV subtypes.We tested the activity of JZTx-14 on mammalian Na studies ,31. Thei current H. The do (n = 5) I,J. Thestivation K. This sV1.2 was used as a representative channel and the effect of JZTx-14 on its activation was tested. As shown by the traces in V1.2 currents at every depolarizing voltage, and the toxin did not change its peak current voltage or reversal voltage (n = 10). Additionally, we compared the I\u2013V relationships by normalizing the currents in the toxin group to their maximum peak current . The data showed that the curves superimposed between the depolarizing voltages of \u221250 mV to +50 mV, while the proportion of opening channels at voltages of +60 mV to +100 mV in the toxin group was higher than that in the control group . We propose that JZTx-14 trapped the NaV1.2 DII voltage sensor in one of the deactivated states. We further conducted the toxin dissociation assay to explore the state-dependent binding of JZTx-14 with NaV1.2. As shown by the voltage protocol in V1.2 currents by binding to the DII voltage sensor. Saturating doses of JZTx-14, HNTx-III, and TTX fully blocked the NaV1.2 currents elicited by t1. However, in contrast to a large recovery of the NaV1.2 current in t2 in the HNTx-III group, no current recovery was observed in the JZTx-14 and TTX groups (n = 3\u20135). It is reasonable that strong depolarization could not cause TTX dissociation from NaV1.2 as its action mechanism. The action mode of JZTx-14, which is characterized by its state-independent binding with NaV1.2 and the irreversible blocking of NaV1.2 currents, is distinct from other toxins acting on the NaV DII voltage sensor, such as HNTx-III and HWTx-IV [Nacurrents D. These  HWTx-IV ,33.V, NsvBa, was relatively weaker, with 1 \u00b5M toxin inhibiting its currents by 46.8 \u00b1 3.3% (n = 6). The dose\u2013response curves showed that the IC50 values of JZTx-14 for the NaChBac and NsvBa channels were 320 \u00b1 38 nM and 1400 \u00b1 200 nM, respectively (n = 5\u20137). For the bacterial NaVs NaVPz and NaVSP, 1 \u00b5M JZTx-14 only caused a 34.5 \u00b1 6.5% and 25.7 \u00b1 5.7% inhibition of their currents, respectively (n = 3). JZTx-27 is another NaChBac and NsvBa channel antagonist characterized in the same venom [Vs. However, compared with JZTx-27, JZTx-14 showed more potent activity on mammalian NaVs. As for mammalian NaVs, we tested the effect of JZTx-14 on the steady-state activation and inactivation of NaChBac. As shown in a = \u221233.8 \u00b1 0.41 mV and \u201323.7 \u00b1 0.98 mV, Ka = 6.2 \u00b1 0.35 mV and 9.9 \u00b1 0.87 mV, for control and toxin-treated channels, respectively; n = 5). Furthermore, the toxin positively shifted the steady-state inactivation relationship of NaChBac . These data suggest that JZTx-14 acted on NaChBac as a gating modifier.As shown in 8 \u00b1 3.3% B, n = 6.me venom . In the Vs determined this loop in NaChBac to be 103\u2013FAGAQFV\u2013109 , 832.6 \u00b1 42.1 nM for F103A (n = 7), 653.3 \u00b1 92.1 nM for G105A (n = 5), 809.8 \u00b1 87.5 nM for Q107A (n = 6), 3472.3 \u00b1 195.7 nM for F108A (n = 6), and 1367.3 \u00b1 129.3 nM for V109A (n = 5) mutant channel, respectively. We further tested the effect of JZTx-27 on the F108A mutant channel, and the IC50 was determined as 116.8 \u00b1 11.0 nM, with only a ~2.5-fold change being observed when compared with wild NaChBac (IC50 = 46.7 \u00b1 1.9 nM) (n = 6\u20137). These data suggest that JZTx-14 and JZTx-27 bind to different key residues in NaChBac, although their interacting surfaces in the channel might partially overlap.Our previous study showed that JZTx-27 bound with the S3\u20134 extracellular loop of NaChBac, with the 103th phenylalanine (F103) being the key residue . We analAQFV\u2013109 H,I. The C. jinzhao as a broad spectrum NaVs toxin that acted on mammalian NaV1.2\u20131.9 subtypes and the bacterial NaChBac channel. It showed multiple phenotypes in tested NaVs, with the toxin inhibiting the fast inactivation of the NaV1.9 channel and mainly inhibiting the peak currents of NaV1.2\u20131.8 and NaChBac. For NaV1.2\u20131.7 subtypes, the toxin also slightly inhibited their fast inactivation. The promiscuous mammalian NaVs inhibitory activity of JZTx-14 resembled that of GrTx1 and GsAF1 [V1.5 channel. JZTx-14 acted on mammalian NaVs and the NaChBac channel as a gating modifier and the DII S3\u20134 loops of mammalian NaVs and the NaChBac S3\u20134 loop were involved in toxin association; however, the action mode of JZTx-14 on mammalian NaVs was a departure from classical site 4 toxins. We suggest that JZTx-14 might be useful in exploring the pharmacology of NaVs as follows.This study purified and characterized JZTx-14 from the venom of nd GsAF1 . HoweverV channel to inhibit both the activation and fast inactivation of the NaV1.2\u20131.7, especially for the NaV1.2 and NaV1.3 channels. This is not surprising, as several toxins such as ProTx-I, ProTx-II, and TsVII were shown to interact with multiple regions in NaVs [V1.2\u20131.8 channels, its primary and high-affinity binding site in them might be site 1 or site 4 [V pore [V1.2 channel in V, and JZTx-14 resembled KIIIA in irreversible binding with NaV [V DII voltage sensor and trapping it in the deactivated state. Additionally, the NaV1.5/1.9DIIS3\u20134 chimeric channel clearly showed that the DII S3\u20134 extracellular loop is involved in JZTx-14 association. However, the observations that JZTx-14 irreversibly and state-independently blocked NaVs were departures from the action mode of classical NaV site 4 toxins, such as HNTx-III and HWTx-IV [V DII voltage sensor could be easily washed off by bath solution and easily dissociated by voltage sensor conformation change, both of these were not observed in our experiments. Moreover, the irreversible binding of JZTx-14 to NaV1.2\u20131.8 could not be simply explained by its potential membrane-binding capability, as the action of JZTx-14 on the NaChBac channel was reversible. It is possible that JZTx-14 embedded into the membrane and bound to a deep region in the voltage sensor of NaV1.2\u20131.8 by recognizing a common structure in these channels; however, this binding might be silent, and the toxin inhibitory effect on NaVs requires the participation of the S3\u20134 extracellular loop. We raised a model that JZTx-14 seated in a toxin pocket that was deep within the voltage sensor, and used another surface to interact with and trap the S3\u20134 loop in its deactivated state from the inside and accordingly impeded the channel activation. This model needs to be validated by more solid data in future studies, and differs from that of the proposed action mode of classical site 4 toxins such as \u03b2-scorpion toxin CssIV, in which the toxin binds to the S1\u20132 and S3\u20134 loops cleft from the extracellular side [In this study, JZTx-14 seemed to bind to two sites in mammalian Na in NaVs ,36. As Jr site 4 . Guanidi [V pore ,38. We cwith NaV , the fac HWTx-IV ,33. As ilar side .Vs were inactivated via a C-type inactivation mechanism, in which the collapse of the selectivity filter served as an inactivation gate [The mutation study showed that JZTx-14 acted on NaChBac by binding to the S3\u20134 extracellular loop, with the 108th phenylalanine (F108) being the key residue. This action mode resembled the previously reported NaChBac channel toxin JZTx-27, although their key residues in the channel were different . We specion gate . The staion gate . The datVs were deemed to be ancestors of mammalian 24TMs voltage-gated calcium and sodium channels [Vs and NaChBac [Vs, and it was assumed that the isoflurane binding sites in NaChBac and mammalian NaVs are conserved [Vs with similar affinity, but with a distinct mechanism of isoflurane. Whether or not the toxin used the same toxin surface for interacting with these two disparate types of channels remains to be explored.The bacterial Nachannels ,45. Sevechannels . Additio NaChBac . Furtheronserved . In thisC. jingzhao was collected by an electric stimulation method as previously described [2O to a final concentration of 5 mg/mL immediately before being subjected to RP-HPLC purification. The first round of semi-preparative RP-HPLC purification was performed in a Hanbon HPLC system  by using a C18 column  and a 45-min linear acetonitrile gradient from 10% to 55% at a flow rate of 3 mL/min. The fraction containing JZTx-14 was collected, lyophilized, and subjected to the second round of RP-HPLC purification in Waters 2795 HPLC system  by using an analytic C18 column  and a 24-min linear acetonitrile gradient from 20% to 44% at a flow rate of 1 mL/min. The JZTx-14 store solution was made by dissolving lyophilized toxin in sterile ddH2O, and the toxin concentration was determined using the Enhanced BCA Protein Assay Kit following the manufacturer\u2019s instruction . The standard curve of the assay was created using synthetic HWTx-I toxin of known concentration. The N-terminal 11 amino acid sequence of JZTx-14 was determined by Edman degradation in an automatic protein sequencer .The venom of the spider escribed . The colTM 5800 system . Briefly, 1 \u00b5L JZTx-14 sample solution was mixed with 1 \u00b5L saturated CCA (\u03b1-cyano-4-hydroxycinnamic acid) solution, pointed onto a sample plate, and then subjected to mass spectrometric analysis in positive reflectron mode. The initial laser intensity was set to 3800, and was finely adjusted to obtain a good resolution and signal-to-noise ratio. Mass calibration was achieved using an external standard. We determined the C-terminal sequence of JZTx-14 by combining chymotrypsin digestion and LC-MS analysis in a Q ExactiveTM mass spectrometer . Briefly, 10 \u00b5g JZTx-14 was reduced, alkylated, and digested with chymotrypsin and subjected to LC-MS analysis. The data was searched against the venom gland cDNA library database of Chilobrachys jingzhao by using MaxQuant.The purity and molecular weight of the purified JZTx-14 was analyzed in an AB SCIEX TOF/TOFVs NaChBac, NsvBa, NaVPz and NaVSp were from professor David E Clapham lab , and were cloned in a pTracer-CMV2 vector. The mammalian NaV cDNA clones (NaV1.2\u2013NaV1.8) were from professor Theodore Cummins lab , and were cloned in the pCDNA3.1 or pCMV-blank vectors. The NaV1.8/1.7L5 channel and the NaV1.9-EGFP channel were as described in our previous studies [E. coli DH5\u03b1 chemical competent cells. All of the mutants were sequenced to ensure that the correct mutations were made. The CHO-K1 cells and HEK293T cells were used for bacterial NaVs and mammalian NaVs NaV1.2\u2013NaV1.8 heterologous expression, respectively. Cells were cultured under standard conditions  in a humidified incubator and transfection was performed when cells reached 80\u201390% confluence. All of the transfections were performed using Lipofectamine 2000 following the manufacturer\u2019s instructions . Four to six hours after transfection, cells were seeded onto PLL-coated coverslips. Twenty-four hours after transfection, cells were ready for patch-clamp analysis. ND7/23 cells were used for NaV1.9-EGFP chimeric channel expression and the conditions were as previously described [The cDNA clones of bacterial Na studies ,31. MutaV currents, the bath solution contained (in mM): 140 NaCl, 2 CaCl2, 1 MgCl2, 5 KCl, 10 glucose and 20 HEPES (pH = 7.3); the pipette solution contained (in mM): 140 CsF, 1 EGTA, 10 NaCl and 10 HEPES (pH = 7.3). TTX was added to bath solution to a final concentration of 1 \u00b5M when recording NaV1.9 currents. Unless otherwise indicated, all chemicals were products of Sigma-Aldrich . After breaking in, the serial resistance was controlled to be less than 10 M\u03a9, the voltage error was minimized by using 80% serial resistance compensation, and the speed value for compensation was 10 \u00b5s. To minimize the fast capacitance, only the tip of the pipet was filled with pipet solution, and the artificial capacitance effect was canceled by using the computer-controlled circuit of the amplifier. Data were acquired by the PatchMaster software  and analyzed by Sigmaplot 10.0 , Igor Pro 6.10A  and Graphpad Prism 5.01 .Whole-cell current recordings were performed in an EPC10 USB patch-clamp platform . The recording pipets were prepared from glass capillaries (thickness = 0.225 mm) with a PC-10 puller , and the pipet resistance was controlled to be 1.5\u20133 M\u03a9. For recording Na1/2, V and K represent the midpoint voltage of kinetics, the test voltage and the slope factor, respectively. The dose\u2013response curves were fitted by a Hill logistic equation to estimate the potency (IC50) of the toxin.Data were presented as mean \u00b1 SEM. N was presented as the number of separate experimental cells. The G\u2013V and SSI curves were fitted by a Boltzmann equation:", "texts": ["Vs) has advanced our understanding of their pharmacology. Herein, we report the purification and characterization of a novel non-selective mammalian and bacterial NaVs toxin, JZTx-14, from the venom of the spider Chilobrachys jingzhao. This toxin potently inhibited the peak currents of mammalian NaV1.2\u20131.8 channels and the bacterial NaChBac channel with low IC50 values (<1 \u00b5M), and it mainly inhibited the fast inactivation of the NaV1.9 channel. Analysis of NaV1.5/NaV1.9 chimeric channel showed that the NaV1.5 domain II S3\u20134 loop is involved in toxin association. Kinetics data obtained from studying toxin\u2013NaV1.2 channel interaction showed that JZTx-14 was a gating modifier that possibly trapped the channel in resting state; however, it differed from site 4 toxin HNTx-III by irreversibly blocking NaV currents and showing state-independent binding with the channel. JZTx-14 might stably bind to a conserved toxin pocket deep within the NaV1.2\u20131.8 domain II voltage sensor regardless of channel conformation change, and its effect on NaVs requires the toxin to trap the S3\u20134 loop in its resting state. For the NaChBac channel, JZTx-14 positively shifted its conductance-voltage (G\u2013V) and steady-state inactivation relationships. An alanine scan analysis of the NaChBac S3\u20134 loop revealed that the 108th phenylalanine (F108) was the key residue determining the JZTx-14\u2013NaChBac interaction. In summary, this study provided JZTx-14 with potent but promiscuous inhibitory activity on both the ancestor bacterial NaVs and the highly evolved descendant mammalian NaVs, and it is a useful probe to understand the pharmacology of NaVs.Exploring the interaction of ligands with voltage-gated sodium channels (Na V) is composed of a pore-forming alpha subunit and one or two covalently or non-covalently associated beta subunits. The alpha subunit has a topological structure of 24 transmembrane segments (TMs), which could be further divided into four homologous domains, with each domain containing six TMs. A total of nine NaV subtypes have been identified in mammals with different tissue distributions and accordingly diverse functions: the NaV1.1\u20131.3 subtypes that are mainly located in the central nervous system (CNS); the NaV1.4\u20131.5 subtypes that are expressed in the skeletal muscle cells and the cardiac myocyte cells, respectively; the NaV1.7\u20131.9 subtypes that are mostly restricted to the peripheral nervous system (PNS); and the NaV1.6 channel, which is expressed in both the CNS and the PNS [Vs were expressed in non-excitable cells such as astrocytes, microglia, macrophages, and cancer cells, and functioned in a non-canonical way [+ selectivity mechanism of mammalian NaVs are yet to be explored, and the milestone progresses regarding the cryo-EM structures of eukaryotic NaVs such as cockroach NaVPas [V1.4 [V1.4 [Vs, and are rich mines for developing drugs for treating NaV-related diseases and discovering probes for NaV researches [Vs; among these, site 1, site 3, site 4, and site 6 are binding sites for small disulfide-rich peptides from animal venoms [V1.2\u20131.8 channels, it is difficult to purify NaV subtype-specific modulators from animal venoms. This is because that these toxins might bind to NaVs by recognizing a common structure in them, which is similar to that of tetrodotoxin (TTX) occluding the pore of TTX-sensitive NaVs  by recognizing the conserved structures in them [V subtypes with comparable affinity are rare, as there are substantial differences between them. Furthermore, NaV voltage sensor binding peptide toxins (site 3 and site 4 toxins) have always shown reversible and state-dependent binding property. The identification of toxins deviating from these rules would advance our understanding of the pharmacology of NaV channels.The mammalian voltage-gated sodium channel  template for designing drugs targeting human NaVs [Vs, relatively few peptide toxins acting on bacterial NaVs have been reported. Mammalian Naell line . Since tian NaVs ,16. Thisreported ,21,22,23ic level . The cryevel [Vs . Further in them ,27. In toflurane ,28. Addiman NaVs . HoweverChilobrachys jingzhao, is purified and characterized. It showed promiscuous inhibitory activity on mammalian NaV1.2\u20131.8 channels and the bacterial NaChBac channel, and also inhibited the fast inactivation of the NaV1.9 channel. Kinetics data and mutation analysis proved that JZTx-14 was a gating modifier of both mammalian and bacterial NaVs. However, its irreversible blocking effect on mammalian NaV and its state-independent binding with the channel suggested that the action mode of JZTx-14 might be different from those classical site 4 toxins: that is, JZTx-14 might stably bind to a conserved toxin pocket deep within the NaV1.2\u20131.8 voltage sensor regardless of channel conformation change, however, its inhibitory effect on NaVs requires the toxin to trap the S3\u20134 loop in its resting state. This study provided a novel toxin to understand the pharmacology of both the mammalian and bacterial NaVs.In the present study, a novel peptide toxin, JZTx-14, from the venom of the spider C. jingzhao, JZTx-14, which non-selectively and potently inhibited NaV1.2\u20131.8 currents. This toxin had a retention time of 40.8 min in the RP-HPLC purification of the venom  (https://blast.ncbi.nlm.nih.gov/Blast.cgi) matched the toxins JZTx-14 and Jingzhaotoxin F4-32.60 (Chilobrachys jingzhao matched JZTx-14 with the highest score (UniProtKB/Swiss-Prot accession number: B1P1C0.1), with an identification coverage ratio of 100%. 1-C2-C3C4-C5-C6), and the mode of the disulfide bonds might be C1-C4, C2-C5, and C3-C6 (the number indicates the relative position of cysteine in the sequence). Sequence alignment showed that JZTx-14 had low identity with the peptide toxins in the database  C. AdditiF4-32.60 D. JingzhF4-32.60 D. We anadatabase F.Vs NaV1.2\u20131.9 heterologously expressed in HEK293T or ND7/23 cells. The NaV1.8 and NaV1.9 channels were chimeras, as described in our previous studies [V1.2\u20131.7 currents , 426.3 \u00b1 48.8 nM for NaV1.3 (n = 5), 290.1 \u00b1 23.2 nM for NaV1.4 (n = 6), 478.0 \u00b1 32.0 nM for NaV1.5 (n = 5), 158.6 \u00b1 29.4 nM for NaV1.6 (n = 4), 188.9 \u00b1 46.3 nM for NaV1.7 (n = 6), and 824.0 \u00b1 68.7 nM for NaV1.8 (n = 5)  S3\u20134 loop with that of NaV1.9, and tested its response to JZTx-14. The data showed that 2 \u00b5M toxin only slightly inhibited its peak currents, but profoundly slowed its fast inactivation ; all of these mutants showed no significant change of their sensitivity to JZTx-14, and an alanine scan mutation analysis of the DII S3b\u2013S4 paddle motif (from the 795th glutamine to the 808th arginine) did not identify any key site (data not shown). We propose that JZTx-14 associated with the DII S3\u20134 loops of NaV1.2\u20131.8 by binding multiple amino acids in this region. It well explained the targets proximity of JZTx-14 among NaV subtypes.We tested the activity of JZTx-14 on mammalian Na studies ,31. Thei current H. The do (n = 5) I,J. Thestivation K. This sV1.2 was used as a representative channel and the effect of JZTx-14 on its activation was tested. As shown by the traces in V1.2 currents at every depolarizing voltage, and the toxin did not change its peak current voltage or reversal voltage (n = 10). Additionally, we compared the I\u2013V relationships by normalizing the currents in the toxin group to their maximum peak current . The data showed that the curves superimposed between the depolarizing voltages of \u221250 mV to +50 mV, while the proportion of opening channels at voltages of +60 mV to +100 mV in the toxin group was higher than that in the control group . We propose that JZTx-14 trapped the NaV1.2 DII voltage sensor in one of the deactivated states. We further conducted the toxin dissociation assay to explore the state-dependent binding of JZTx-14 with NaV1.2. As shown by the voltage protocol in V1.2 currents by binding to the DII voltage sensor. Saturating doses of JZTx-14, HNTx-III, and TTX fully blocked the NaV1.2 currents elicited by t1. However, in contrast to a large recovery of the NaV1.2 current in t2 in the HNTx-III group, no current recovery was observed in the JZTx-14 and TTX groups (n = 3\u20135). It is reasonable that strong depolarization could not cause TTX dissociation from NaV1.2 as its action mechanism. The action mode of JZTx-14, which is characterized by its state-independent binding with NaV1.2 and the irreversible blocking of NaV1.2 currents, is distinct from other toxins acting on the NaV DII voltage sensor, such as HNTx-III and HWTx-IV [Nacurrents D. These  HWTx-IV ,33.V, NsvBa, was relatively weaker, with 1 \u00b5M toxin inhibiting its currents by 46.8 \u00b1 3.3% (n = 6). The dose\u2013response curves showed that the IC50 values of JZTx-14 for the NaChBac and NsvBa channels were 320 \u00b1 38 nM and 1400 \u00b1 200 nM, respectively (n = 5\u20137). For the bacterial NaVs NaVPz and NaVSP, 1 \u00b5M JZTx-14 only caused a 34.5 \u00b1 6.5% and 25.7 \u00b1 5.7% inhibition of their currents, respectively (n = 3). JZTx-27 is another NaChBac and NsvBa channel antagonist characterized in the same venom [Vs. However, compared with JZTx-27, JZTx-14 showed more potent activity on mammalian NaVs. As for mammalian NaVs, we tested the effect of JZTx-14 on the steady-state activation and inactivation of NaChBac. As shown in a = \u221233.8 \u00b1 0.41 mV and \u201323.7 \u00b1 0.98 mV, Ka = 6.2 \u00b1 0.35 mV and 9.9 \u00b1 0.87 mV, for control and toxin-treated channels, respectively; n = 5). Furthermore, the toxin positively shifted the steady-state inactivation relationship of NaChBac . These data suggest that JZTx-14 acted on NaChBac as a gating modifier.As shown in 8 \u00b1 3.3% B, n = 6.me venom . In the Vs determined this loop in NaChBac to be 103\u2013FAGAQFV\u2013109 , 832.6 \u00b1 42.1 nM for F103A (n = 7), 653.3 \u00b1 92.1 nM for G105A (n = 5), 809.8 \u00b1 87.5 nM for Q107A (n = 6), 3472.3 \u00b1 195.7 nM for F108A (n = 6), and 1367.3 \u00b1 129.3 nM for V109A (n = 5) mutant channel, respectively. We further tested the effect of JZTx-27 on the F108A mutant channel, and the IC50 was determined as 116.8 \u00b1 11.0 nM, with only a ~2.5-fold change being observed when compared with wild NaChBac (IC50 = 46.7 \u00b1 1.9 nM) (n = 6\u20137). These data suggest that JZTx-14 and JZTx-27 bind to different key residues in NaChBac, although their interacting surfaces in the channel might partially overlap.Our previous study showed that JZTx-27 bound with the S3\u20134 extracellular loop of NaChBac, with the 103th phenylalanine (F103) being the key residue . We analAQFV\u2013109 H,I. The C. jinzhao as a broad spectrum NaVs toxin that acted on mammalian NaV1.2\u20131.9 subtypes and the bacterial NaChBac channel. It showed multiple phenotypes in tested NaVs, with the toxin inhibiting the fast inactivation of the NaV1.9 channel and mainly inhibiting the peak currents of NaV1.2\u20131.8 and NaChBac. For NaV1.2\u20131.7 subtypes, the toxin also slightly inhibited their fast inactivation. The promiscuous mammalian NaVs inhibitory activity of JZTx-14 resembled that of GrTx1 and GsAF1 [V1.5 channel. JZTx-14 acted on mammalian NaVs and the NaChBac channel as a gating modifier and the DII S3\u20134 loops of mammalian NaVs and the NaChBac S3\u20134 loop were involved in toxin association; however, the action mode of JZTx-14 on mammalian NaVs was a departure from classical site 4 toxins. We suggest that JZTx-14 might be useful in exploring the pharmacology of NaVs as follows.This study purified and characterized JZTx-14 from the venom of nd GsAF1 . HoweverV channel to inhibit both the activation and fast inactivation of the NaV1.2\u20131.7, especially for the NaV1.2 and NaV1.3 channels. This is not surprising, as several toxins such as ProTx-I, ProTx-II, and TsVII were shown to interact with multiple regions in NaVs [V1.2\u20131.8 channels, its primary and high-affinity binding site in them might be site 1 or site 4 [V pore [V1.2 channel in V, and JZTx-14 resembled KIIIA in irreversible binding with NaV [V DII voltage sensor and trapping it in the deactivated state. Additionally, the NaV1.5/1.9DIIS3\u20134 chimeric channel clearly showed that the DII S3\u20134 extracellular loop is involved in JZTx-14 association. However, the observations that JZTx-14 irreversibly and state-independently blocked NaVs were departures from the action mode of classical NaV site 4 toxins, such as HNTx-III and HWTx-IV [V DII voltage sensor could be easily washed off by bath solution and easily dissociated by voltage sensor conformation change, both of these were not observed in our experiments. Moreover, the irreversible binding of JZTx-14 to NaV1.2\u20131.8 could not be simply explained by its potential membrane-binding capability, as the action of JZTx-14 on the NaChBac channel was reversible. It is possible that JZTx-14 embedded into the membrane and bound to a deep region in the voltage sensor of NaV1.2\u20131.8 by recognizing a common structure in these channels; however, this binding might be silent, and the toxin inhibitory effect on NaVs requires the participation of the S3\u20134 extracellular loop. We raised a model that JZTx-14 seated in a toxin pocket that was deep within the voltage sensor, and used another surface to interact with and trap the S3\u20134 loop in its deactivated state from the inside and accordingly impeded the channel activation. This model needs to be validated by more solid data in future studies, and differs from that of the proposed action mode of classical site 4 toxins such as \u03b2-scorpion toxin CssIV, in which the toxin binds to the S1\u20132 and S3\u20134 loops cleft from the extracellular side [In this study, JZTx-14 seemed to bind to two sites in mammalian Na in NaVs ,36. As Jr site 4 . Guanidi [V pore ,38. We cwith NaV , the fac HWTx-IV ,33. As ilar side .Vs were inactivated via a C-type inactivation mechanism, in which the collapse of the selectivity filter served as an inactivation gate [The mutation study showed that JZTx-14 acted on NaChBac by binding to the S3\u20134 extracellular loop, with the 108th phenylalanine (F108) being the key residue. This action mode resembled the previously reported NaChBac channel toxin JZTx-27, although their key residues in the channel were different . We specion gate . The staion gate . The datVs were deemed to be ancestors of mammalian 24TMs voltage-gated calcium and sodium channels [Vs and NaChBac [Vs, and it was assumed that the isoflurane binding sites in NaChBac and mammalian NaVs are conserved [Vs with similar affinity, but with a distinct mechanism of isoflurane. Whether or not the toxin used the same toxin surface for interacting with these two disparate types of channels remains to be explored.The bacterial Nachannels ,45. Sevechannels . Additio NaChBac . Furtheronserved . In thisC. jingzhao was collected by an electric stimulation method as previously described [2O to a final concentration of 5 mg/mL immediately before being subjected to RP-HPLC purification. The first round of semi-preparative RP-HPLC purification was performed in a Hanbon HPLC system  by using a C18 column  and a 45-min linear acetonitrile gradient from 10% to 55% at a flow rate of 3 mL/min. The fraction containing JZTx-14 was collected, lyophilized, and subjected to the second round of RP-HPLC purification in Waters 2795 HPLC system  by using an analytic C18 column  and a 24-min linear acetonitrile gradient from 20% to 44% at a flow rate of 1 mL/min. The JZTx-14 store solution was made by dissolving lyophilized toxin in sterile ddH2O, and the toxin concentration was determined using the Enhanced BCA Protein Assay Kit following the manufacturer\u2019s instruction . The standard curve of the assay was created using synthetic HWTx-I toxin of known concentration. The N-terminal 11 amino acid sequence of JZTx-14 was determined by Edman degradation in an automatic protein sequencer .The venom of the spider escribed . The colTM 5800 system . Briefly, 1 \u00b5L JZTx-14 sample solution was mixed with 1 \u00b5L saturated CCA (\u03b1-cyano-4-hydroxycinnamic acid) solution, pointed onto a sample plate, and then subjected to mass spectrometric analysis in positive reflectron mode. The initial laser intensity was set to 3800, and was finely adjusted to obtain a good resolution and signal-to-noise ratio. Mass calibration was achieved using an external standard. We determined the C-terminal sequence of JZTx-14 by combining chymotrypsin digestion and LC-MS analysis in a Q ExactiveTM mass spectrometer . Briefly, 10 \u00b5g JZTx-14 was reduced, alkylated, and digested with chymotrypsin and subjected to LC-MS analysis. The data was searched against the venom gland cDNA library database of Chilobrachys jingzhao by using MaxQuant.The purity and molecular weight of the purified JZTx-14 was analyzed in an AB SCIEX TOF/TOFVs NaChBac, NsvBa, NaVPz and NaVSp were from professor David E Clapham lab , and were cloned in a pTracer-CMV2 vector. The mammalian NaV cDNA clones (NaV1.2\u2013NaV1.8) were from professor Theodore Cummins lab , and were cloned in the pCDNA3.1 or pCMV-blank vectors. The NaV1.8/1.7L5 channel and the NaV1.9-EGFP channel were as described in our previous studies [E. coli DH5\u03b1 chemical competent cells. All of the mutants were sequenced to ensure that the correct mutations were made. The CHO-K1 cells and HEK293T cells were used for bacterial NaVs and mammalian NaVs NaV1.2\u2013NaV1.8 heterologous expression, respectively. Cells were cultured under standard conditions  in a humidified incubator and transfection was performed when cells reached 80\u201390% confluence. All of the transfections were performed using Lipofectamine 2000 following the manufacturer\u2019s instructions . Four to six hours after transfection, cells were seeded onto PLL-coated coverslips. Twenty-four hours after transfection, cells were ready for patch-clamp analysis. ND7/23 cells were used for NaV1.9-EGFP chimeric channel expression and the conditions were as previously described [The cDNA clones of bacterial Na studies ,31. MutaV currents, the bath solution contained (in mM): 140 NaCl, 2 CaCl2, 1 MgCl2, 5 KCl, 10 glucose and 20 HEPES (pH = 7.3); the pipette solution contained (in mM): 140 CsF, 1 EGTA, 10 NaCl and 10 HEPES (pH = 7.3). TTX was added to bath solution to a final concentration of 1 \u00b5M when recording NaV1.9 currents. Unless otherwise indicated, all chemicals were products of Sigma-Aldrich . After breaking in, the serial resistance was controlled to be less than 10 M\u03a9, the voltage error was minimized by using 80% serial resistance compensation, and the speed value for compensation was 10 \u00b5s. To minimize the fast capacitance, only the tip of the pipet was filled with pipet solution, and the artificial capacitance effect was canceled by using the computer-controlled circuit of the amplifier. Data were acquired by the PatchMaster software  and analyzed by Sigmaplot 10.0 , Igor Pro 6.10A  and Graphpad Prism 5.01 .Whole-cell current recordings were performed in an EPC10 USB patch-clamp platform . The recording pipets were prepared from glass capillaries (thickness = 0.225 mm) with a PC-10 puller , and the pipet resistance was controlled to be 1.5\u20133 M\u03a9. For recording Na1/2, V and K represent the midpoint voltage of kinetics, the test voltage and the slope factor, respectively. The dose\u2013response curves were fitted by a Hill logistic equation to estimate the potency (IC50) of the toxin.Data were presented as mean \u00b1 SEM. N was presented as the number of separate experimental cells. The G\u2013V and SSI curves were fitted by a Boltzmann equation:"]}
{"representative": "The optimal technique for airway management in patients with cervical pathology remains unclear. Intubating laryngeal mask airway devices such as LMA CTrach and LMA Fastrach have not been compared for cervical spine (C-spine) movements in the context of cervical pathology. The present study aimed to determine upper C-spine movements by radiography during intubation with different devices as well as comparing the duration and success of intubation in cervical surgery.2 were excluded. Participants were randomized to one of the 3 groups: LMA CTrach, LMA Fastrach, or the Macintosh laryngoscope. C-spine motion was evaluated by measuring angles created by bordering vertebrae at cervical 1/2 and 2/3  segments on 2 lateral cervical radiographs for each patient. Intubation time, ease of intubation, number of attempts, and success rate were also documented. Sixty patients scheduled for elective cervical surgery were registered in this prospective, randomized study. Patients with cervical trauma/injury, previous neck surgery, and body mass index (BMI) of >35 kg/mDemographic data were similar in all the groups. The cervical movement with LMA CTrach and LMA Fastrach compared to the Macintosh laryngoscope were similar at C1/2. However, LMA CTrach significantly reduced extension compared to LMA Fastrach and Macintosh laryngoscopes at C2/3. Duration of intubation was significantly shorter with the Macintosh laryngoscope. The rate of successful intubation was 80% with LMA Fastrach and 100% with both LMA CTrach and the Macintosh laryngoscopes.The LMA CTrach laryngoscopy involves less upper C-spine movement than the LMA Fastrach and does not increase the duration of the intubation period.  Intubation with various airway devices causes cervical spine (C-spine) extension to some degree. The process gains importance especially in emergency situations with cervical injury and in C-spine surgeries . The main concerns of anesthesiologists for airway management both in cervical injury and C-spine surgeries include avoiding prolonged intubation time and preventing neurologic damage due to excess cervical movements .Conventional laryngoscopy with a Macintosh blade remains the most familiar way to enable tracheal intubation. However, maneuvering for intubation and adjustment of the oropharyngeal and laryngeal axes produces C-spine movement [4]. In a recent systemic review, alternative intubation techniques performed in patients with cervical immobilization were compared with the Macintosh laryngoscopy [5]. The authors concluded that evidence of the efficacy of alternative devices was missing. Fiberoptic intubation is still the most ideal technique to secure an airway in patients with predicted difficult intubation [2]. Fiberoptic laryngoscopy is considered to facilitate the least cervical movement during laryngoscopy but has several limitations like requiring a cooperative patient and lasting a long time, making it unsuitable for emergencies . However, as intubating laryngeal mask airways (ILMAs), LMA CTrach and LMA Fastrach are alternative techniques that may be useful when fiberoptic bronchoscope is not available. ILMAs have been validated for ventilation and as a conduit to tracheal intubation in patients with difficult airways. LMA CTrach was developed from LMA Fastrach with additional advantageous features like visualizing the glottis and intubation process . However, both devices require experience to operate and the administration may prolong intubation time. Previous radiographic and fluoroscopic studies, purporting to evaluate C-spine movement during intubation with various intubating techniques, were carried out. . Intubating laryngeal mask airways have been compared for the success of tracheal intubation . However, there have been no studies investigating C-spine movements using both ILMAs. Moreover, the effects of different intubation techniques on cervical movements were followed among healthy subjects in nonemergency situations not including neck, throat, or cervical surgeries in patients with cervical immobility due to manual in-line stabilization or cervical collars and in cadaveric models in most studies . Comparative studies performed on patients with cervical pathologies who undergo cervical surgery are lacking in the literature. Therefore, this prospective, randomized radiographic study was conducted to compare the movements of the upper C-spine  during laryngoscopy via LMA Fastrach, LMA CTrach, and Macintosh laryngoscopes in patients with lower cervical pathology undergoing C-spine surgery. The secondary outcomes were the comparison of the intubation success and the duration. The ethics committee of the School of Medicine of Erciyes University approved this prospective, randomized, and controlled study (reference number: 2011/177). All the patients were informed about the study and written consent was obtained. Inclusion criteria were American Society of Anesthesiologists (ASA) physical status of I\u2013III, ages between 18 and 70 years old, and patients undergoing elective C-spine surgery. Patients with documented cervical trauma or injury, previous neck surgery, body mass index (BMI) of >35 kg/m2, the possibility of pregnancy, or failed tracheal intubation (more than 2 intubation attempts with a device) were excluded. All patients\u2019 preoperative height, weight, ASA physical status, BMI, and Mallampati scores were documented. Electrocardiography, noninvasive blood pressure measurement, and pulse-oximeter were monitored in all patients in a standard fashion. Before anesthesia induction, the patients were positioned in a neutral position. Following preoxygenation, anesthesia was induced with intravenous (IV) 2 mg/kg propofol, 1 mg/kg lidocaine, 0.5 \u00b5g/kg remifentanil, and 0.6 mg/kg rocuronium, and maintenance was achieved with sevoflurane in an air-oxygen mixture and IV infusion of remifentanil. In the operating room, 63 patients were randomly assigned by a computer random number generator to one of the 3 groups, corresponding to the 3 airway devices: Macintosh laryngoscope (Group M), LMA Fastrach (Group F), or LMA CTrach (Group C). We did not stabilize the head and neck or apply cricoid pressure. In Group M patients, conventional direct laryngoscopy was performed. The diameter of the endotracheal tube (ETT) was 7 or 7.5 mm in females and 8 mm in males. In Group F, size 3, 4, or 5 LMA Fastrach  depending on the weight of the patient was applied in accordance with the manufacturer\u2019s instructions. A silicone reinforced ETT was lubricated and inserted. If the right position of the tube was achieved without resistance, the ETT was advanced into the trachea and the cuff was inflated. The position of the ETT was determined by auscultation and capnography. Subsequently, a special stabilizing rod was used to remove the LMA Fastrach. In Group C, size 3, 4, or 5 LMA CTrach  was preferred depending on the weight of the patient. Initially, LMA CTrach was inserted without the viewer on, just as LMA Fastrach was applied. The cuff was inflated and the patient was ventilated. The viewer was then attached to the connector while holding the handle. When a clear image of the glottis and vocal cords was achieved, an ETT was inserted and intubation was visualized, and the ETT cuff was inflated. The viewer was then detached, and LMA CTrach was removed following the same procedure as for LMA Fastrach. The same experienced anesthesiologist, who had previously performed at least 100 intubations with each of LMA CTrach and LMA Fastrach and 500 intubations with the Macintosh laryngoscope, performed all laryngoscopies in order to minimize interoperator variability. The intubation techniques were recorded with a portable X-ray machine. Two recordings were performed a steady distance from the patient and the tube in the lateral position. The first was taken in a neutral position before the intubation process and the second was taken when the best view of the glottis was achieved with the LMA CTrach and Macintosh laryngoscopes. For the LMA Fastrach, if no resistance was felt as the ETT was advanced through the mask aperture into the trachea, it was thought to be at correct tube positioning and indicated time for the fluoroscopy. The movements of the cervical 1-2 and 2-3 segments were evaluated in radiographs. First we drew a reference line, which follows the cervical 2 dorsal alignment. Then we drew two more lines, which transected the driven reference line, the first one between the anterior and posterior arches of the cervical 1 and the other one through the cervical 3 basal plate of C3. Thus, there were two angles observable: one between the reference line and the arches of cervical 1, named alpha (\u03b1), while the second angle, named beta (\u03b2), was located between the reference line and the line passing through the cervical 3 basal plate. The lines were drawn and an investigator, who was unaware of the study group assignments, randomly measured angles using a goniometer in degree (\u00b0) unit. The duration of intubation, the number of attempts, and the intubation success rate were recorded. The duration of the intubation was recorded between the passage of the intubation device through the lips and inflation of the tracheal cuff. Intubation was considered successful if the patient was intubated in less than two attempts and failed in case of more than two. Estimated from the data of Watts et al. [15] (12.9 \u00b1 2.1\u00b0 extension) and based on the assumption of \u03b1 = 0.05, \u03b2 = 0.8 to detect 15% reduction in the movement of the upper C-spine, each group would need to include at least 18 patients. Therefore 20 patients per group were planned to be enrolled due to the probability of a 10% drop-out rate. SPSS 15.0 for Windows  was used for the statistical analysis. Data are expressed as mean \u00b1 standard deviation (mean \u00b1 SD), median (min\u2013max), or numbers (n) and percentages (%). Discrete variables  were compared using the chi-square test. For numeric parameters of between-group comparisons, one-way analysis of variance (in the case of parametric test conditions) or the Kruskal\u2013Wallis tests (if parametric test conditions could not be obtained) were used. Multiple comparisons of the Kruskal\u2013Wallis test were done by Mann\u2013Whitney U test with Bonferroni correction. Analysis of variance was used for repeated measures of arterial pressure, heart rate, and oxygen saturation and the angle measurements for both between-group and intergroup comparisons. P < 0.05 was considered statistically significant.Sixty-three patients were allocated to the intervention groups. For one patient, intubation with LMA Fastrach was not possible despite adequate manipulation, even after the third attempt. Following 3 esophageal intubations, correct intubation was achieved by direct laryngoscopy and this patient was excluded from the study. In Group C, the vocal cords of 1 patient could not be visualized despite all maneuvers and the patient was also excluded. One of the patients\u2019 radiographic images could not be printed out so the angle measurement could not be analyzed in Group M. Subsequently, 20 patients per group were analyzed.2, remained stable in all groups and anesthesia was uneventful in all patients. None of the patients had hypertension or tachycardia as a response to laryngoscopy. The demographic data, Mallampati scores, and ASA physical status classification (P > 0.05) were similar in all groups (Table 1). The hemodynamic and ventilation parameters, such as arterial blood pressure, heart rate, oxygen saturation, and end-tidal COCervical alpha (\u03b1) angles in degrees at the C1/2 segment of the study patients are shown in Table 2. Baseline measurements were significantly different in Group M compared with the other groups (P = 0.004). According to the neutral baseline position, angulation of the C1/2 segment (\u03b1 angle) decreased during intubation in Group F (P = 0.042) and in Group M (P = 0.001), whereas there was no significant difference in Group C (P = 0.159). The mean degree of the change in angulation compared with the preinduction baseline values at C1/2 1.2\u00b0, 1.1\u00b0, and 2.9\u00b0 for Groups F, C, and M was not statistically significant.Cervical beta (\u03b2) angles of the studied patients are displayed in Table 3 in degrees. At the C2/3 segment (\u03b2 angle) Groups F and M similarly showed a significant increase  in cervical motion, while there was no difference in Group C during intubation compared with the neutral position. The mean change in \u03b2 angle during intubation was prominent in Groups F and M, but in Group C the extension was statistically less .The mean intubation time was 32 s in Group M, ranging from 10 to 120 s. It took the longest time to intubate patients in Group F and the shortest in Group M (P < 0.001) (Table 4). The mean duration of intubation was 98.8 and 61.0 s for the LMA Fastrach and LMA CTrach, respectively (P < 0.001). The numbers of patients intubated in the first attempt were 18 with the Macintosh laryngoscope, 15 with LMA CTrach, and 11 with LMA Fastrach while two attempts were required for 2, 5, and 5 patients, respectively (Table 4). The number of attempts significantly differed in Group F compared to Group M (P = 0.016). It required more than two attempts and was successful after repositioning the LMA Fastrach in 4 patients. The rate of successful tracheal intubation was 80% with LMA Fastrach and 100% with LMA CTrach and Macintosh laryngoscopes. Group F had the statistically lowest success rate (P = 0.009).The main result of this study is that the LMA CTrach significantly reduced extension compared to LMA Fastrach and Macintosh laryngoscopes at the C2/3 segment (\u03b2 angle) without prolonging intubation time in patients undergoing elective C-spine surgery. According to our hypothesis, both LMA Fastrach and LMA CTrach would be associated with less cervical movement than Macintosh laryngoscopes, which was at least partially confirmed with LMA CTrach for the \u03b2 angle. A study by Sawin et al. investigated the behavior of the intact C-spine during direct laryngoscopy with a Macintosh blade and proved the general assumption that a majority of cervical motions associated with laryngoscopy occur in the upper cervical region [4]. Subaxial segments (under C2) were displaced minimally. Thus, the present study was undertaken to quantify the motion of cervical segments 1/2 and 2/3. The times for radiography were chosen as once before induction and once during laryngoscopy immediately prior to insertion of the endotracheal tube or when the best view of the glottis was achieved as Hindman et al. reported maximal intubation biomechanics occurring at that stage [16]. A cadaver model of cervical instability found that supraglottic airways  caused less or equal C-spine movement compared to the conventional laryngoscopes  [9]. The authors therefore suggested that, due to the ease of training, supraglottic airways could be preferred in cervical trauma patients. Komatsu et al. tested ILMAs for controlling the airway in patients undergoing C-spine surgery who were wearing rigid cervical collars to simulate C-spine injury and found ILMAs a reasonable alternative for facilitating intubation [17]. Panjabi et al. defined the upper limits of the physiological motion as a rotation of over 20\u00b0 in the sagittal plane [18]. The maximum cervical motion at C2/3 in our study was 15\u00b0 for the Macintosh laryngoscope, 12.4\u00b0 for LMA Fastrach, and 7.6\u00b0 for LMA CTrach. In a video-fluoroscopic study, Sahin et al. observed a maximum movement of 18.5\u00b0, 16.7\u00b0, and 8.1\u00b0 during direct laryngoscopy, intubation with ILMA, and fiberoptic laryngoscopy at C1/2 [6]. The maximum cervical motion produced with LMA Fastrach in both studies was close to the angle of the Macintosh laryngoscope. However, it was still lower than the instability limits argued by Panjabi et al. [18]. Even though the extension of the motion produced by LMA CTrach in the present study seems to be less than that produced by fiber optic laryngoscopy in Sahin\u2019s study, it is actually difficult to compare the data of these similar studies. In the present study there was a significant difference in baseline angle measurements at C1/2. We do not recognize this as a study limitation because the initial position of the patient\u2019s head cannot be standardized. However, the degree of cervical extension during laryngoscopy is important. The previous literature reported extension at C1/2 produced with ILMAs ranging from 1\u00b0 to 5\u00b0 and even as high as 7.4\u00b0 . Our result is in line with this range. Nevertheless, variability of the results depends on the heterogeneity introduced by methodological and population differences of the studies and experiences of the investigators. The ability to intubate a trachea under glottis visualization with LMA CTrach was reported with higher first attempt success rates compared with LMA Fastrach [14]. Liu et al. found a 98.9% first attempt success rate for LMA CTrach in 100 patients, while Baskett et al. showed a 79.8% success rate for LMA Fastrach with the experience of 500 cases . Bilgin et al. demonstrated a first attempt success rate of intubation of 54% for ILMAs and 90% for C-Trach [13]. Our success rate, which is 75% with LMA CTrach and 55% with LMA Fastrach, is lower than those in the published literature. The diversity of these results is probably due to the methodological differences, the skills of the investigators, and the sample sizes of the mentioned studies. Nevertheless, in the current study, tracheal intubation was defined as successful only if the patient was intubated in two attempts at most with a device and the rate of successful tracheal intubation was 80% with LMA Fastrach, which statistically had the lowest rate.Secondary spinal injury during airway management is not only a result of the mechanical disruption of the unstable segments, but hypoxia is also likely to cause harm . Although both LMA CTrach and LMA Fastrach administrations may prolong intubation, they have established roles in difficult airway management since they do not interrupt ventilation . Obviously, duration of intubation lasts longer with devices that require different maneuvers compared to the laryngoscopes. In the present study, as the most familiar device for anesthetists, the Macintosh laryngoscope intubation was fastest, while the duration of intubation was significantly longer with LMA Fastrach. These findings are in line with those of Bilgin et al., who reported significantly longer mean intubation time with an ILMA compared to C-Trach and McCoy [13]. Nevertheless, none of the patients in our study presented hypoxia throughout the intubation process. Randomizing the patients without considering their Mallampati scores and evaluating airway difficulties might be a limitation of our study. If the selection of the airway device depended on the possibility of a difficult airway, a selection bias would occur for LMA CTrach over blind intubation using LMA Fastrach. Nevertheless, Mallampati scores were identical between the groups. Another possible shortcoming of the study is that it was impossible to blind the investigator to the airway device and only an independent radiologist who measured the angles was unaware of the study group assignments. Several investigators may have had different skill levels and experiences, so only one investigator performed all laryngoscopies in order to minimize any confounding effects. The third limitation is that tracheal intubations were facilitated with muscle relaxants. Sawin et al. [4] suggested that muscle relaxation using neuromuscular blockade might reduce the need for cervical extension during laryngoscopy. However, even in injury settings muscle relaxants are used to ease the insertion of the endotracheal tube. Finally, the study conclusions may be limited since this project examined only two X-ray graphics instead of dynamic fluoroscopy.In conclusion, airway management with minimal neck movement improves the success of the anesthetic management in C-spine surgery. Moreover, there are limited data that may help to understand C-spine kinetics of the patients with cervical pathologies, especially degenerative disorders requiring surgery. It is thus important to be familiar with the different intubation techniques. However, one should also be aware of their effects on cervical extension. We conclude that the reduced C-spine extension during intubation with LMA CTrach makes it a reasonable alternative compared to LMA Fastrach and Macintosh laryngoscopes in cervical surgery where cervical stability is a concern.", "texts": ["The optimal technique for airway management in patients with cervical pathology remains unclear. Intubating laryngeal mask airway devices such as LMA CTrach and LMA Fastrach have not been compared for cervical spine (C-spine) movements in the context of cervical pathology. The present study aimed to determine upper C-spine movements by radiography during intubation with different devices as well as comparing the duration and success of intubation in cervical surgery.2 were excluded. Participants were randomized to one of the 3 groups: LMA CTrach, LMA Fastrach, or the Macintosh laryngoscope. C-spine motion was evaluated by measuring angles created by bordering vertebrae at cervical 1/2 and 2/3  segments on 2 lateral cervical radiographs for each patient. Intubation time, ease of intubation, number of attempts, and success rate were also documented. Sixty patients scheduled for elective cervical surgery were registered in this prospective, randomized study. Patients with cervical trauma/injury, previous neck surgery, and body mass index (BMI) of >35 kg/mDemographic data were similar in all the groups. The cervical movement with LMA CTrach and LMA Fastrach compared to the Macintosh laryngoscope were similar at C1/2. However, LMA CTrach significantly reduced extension compared to LMA Fastrach and Macintosh laryngoscopes at C2/3. Duration of intubation was significantly shorter with the Macintosh laryngoscope. The rate of successful intubation was 80% with LMA Fastrach and 100% with both LMA CTrach and the Macintosh laryngoscopes.The LMA CTrach laryngoscopy involves less upper C-spine movement than the LMA Fastrach and does not increase the duration of the intubation period.  Intubation with various airway devices causes cervical spine (C-spine) extension to some degree. The process gains importance especially in emergency situations with cervical injury and in C-spine surgeries . The main concerns of anesthesiologists for airway management both in cervical injury and C-spine surgeries include avoiding prolonged intubation time and preventing neurologic damage due to excess cervical movements .Conventional laryngoscopy with a Macintosh blade remains the most familiar way to enable tracheal intubation. However, maneuvering for intubation and adjustment of the oropharyngeal and laryngeal axes produces C-spine movement [4]. In a recent systemic review, alternative intubation techniques performed in patients with cervical immobilization were compared with the Macintosh laryngoscopy [5]. The authors concluded that evidence of the efficacy of alternative devices was missing. Fiberoptic intubation is still the most ideal technique to secure an airway in patients with predicted difficult intubation [2]. Fiberoptic laryngoscopy is considered to facilitate the least cervical movement during laryngoscopy but has several limitations like requiring a cooperative patient and lasting a long time, making it unsuitable for emergencies . However, as intubating laryngeal mask airways (ILMAs), LMA CTrach and LMA Fastrach are alternative techniques that may be useful when fiberoptic bronchoscope is not available. ILMAs have been validated for ventilation and as a conduit to tracheal intubation in patients with difficult airways. LMA CTrach was developed from LMA Fastrach with additional advantageous features like visualizing the glottis and intubation process . However, both devices require experience to operate and the administration may prolong intubation time. Previous radiographic and fluoroscopic studies, purporting to evaluate C-spine movement during intubation with various intubating techniques, were carried out. . Intubating laryngeal mask airways have been compared for the success of tracheal intubation . However, there have been no studies investigating C-spine movements using both ILMAs. Moreover, the effects of different intubation techniques on cervical movements were followed among healthy subjects in nonemergency situations not including neck, throat, or cervical surgeries in patients with cervical immobility due to manual in-line stabilization or cervical collars and in cadaveric models in most studies . Comparative studies performed on patients with cervical pathologies who undergo cervical surgery are lacking in the literature. Therefore, this prospective, randomized radiographic study was conducted to compare the movements of the upper C-spine  during laryngoscopy via LMA Fastrach, LMA CTrach, and Macintosh laryngoscopes in patients with lower cervical pathology undergoing C-spine surgery. The secondary outcomes were the comparison of the intubation success and the duration. The ethics committee of the School of Medicine of Erciyes University approved this prospective, randomized, and controlled study (reference number: 2011/177). All the patients were informed about the study and written consent was obtained. Inclusion criteria were American Society of Anesthesiologists (ASA) physical status of I\u2013III, ages between 18 and 70 years old, and patients undergoing elective C-spine surgery. Patients with documented cervical trauma or injury, previous neck surgery, body mass index (BMI) of >35 kg/m2, the possibility of pregnancy, or failed tracheal intubation (more than 2 intubation attempts with a device) were excluded. All patients\u2019 preoperative height, weight, ASA physical status, BMI, and Mallampati scores were documented. Electrocardiography, noninvasive blood pressure measurement, and pulse-oximeter were monitored in all patients in a standard fashion. Before anesthesia induction, the patients were positioned in a neutral position. Following preoxygenation, anesthesia was induced with intravenous (IV) 2 mg/kg propofol, 1 mg/kg lidocaine, 0.5 \u00b5g/kg remifentanil, and 0.6 mg/kg rocuronium, and maintenance was achieved with sevoflurane in an air-oxygen mixture and IV infusion of remifentanil. In the operating room, 63 patients were randomly assigned by a computer random number generator to one of the 3 groups, corresponding to the 3 airway devices: Macintosh laryngoscope (Group M), LMA Fastrach (Group F), or LMA CTrach (Group C). We did not stabilize the head and neck or apply cricoid pressure. In Group M patients, conventional direct laryngoscopy was performed. The diameter of the endotracheal tube (ETT) was 7 or 7.5 mm in females and 8 mm in males. In Group F, size 3, 4, or 5 LMA Fastrach  depending on the weight of the patient was applied in accordance with the manufacturer\u2019s instructions. A silicone reinforced ETT was lubricated and inserted. If the right position of the tube was achieved without resistance, the ETT was advanced into the trachea and the cuff was inflated. The position of the ETT was determined by auscultation and capnography. Subsequently, a special stabilizing rod was used to remove the LMA Fastrach. In Group C, size 3, 4, or 5 LMA CTrach  was preferred depending on the weight of the patient. Initially, LMA CTrach was inserted without the viewer on, just as LMA Fastrach was applied. The cuff was inflated and the patient was ventilated. The viewer was then attached to the connector while holding the handle. When a clear image of the glottis and vocal cords was achieved, an ETT was inserted and intubation was visualized, and the ETT cuff was inflated. The viewer was then detached, and LMA CTrach was removed following the same procedure as for LMA Fastrach. The same experienced anesthesiologist, who had previously performed at least 100 intubations with each of LMA CTrach and LMA Fastrach and 500 intubations with the Macintosh laryngoscope, performed all laryngoscopies in order to minimize interoperator variability. The intubation techniques were recorded with a portable X-ray machine. Two recordings were performed a steady distance from the patient and the tube in the lateral position. The first was taken in a neutral position before the intubation process and the second was taken when the best view of the glottis was achieved with the LMA CTrach and Macintosh laryngoscopes. For the LMA Fastrach, if no resistance was felt as the ETT was advanced through the mask aperture into the trachea, it was thought to be at correct tube positioning and indicated time for the fluoroscopy. The movements of the cervical 1-2 and 2-3 segments were evaluated in radiographs. First we drew a reference line, which follows the cervical 2 dorsal alignment. Then we drew two more lines, which transected the driven reference line, the first one between the anterior and posterior arches of the cervical 1 and the other one through the cervical 3 basal plate of C3. Thus, there were two angles observable: one between the reference line and the arches of cervical 1, named alpha (\u03b1), while the second angle, named beta (\u03b2), was located between the reference line and the line passing through the cervical 3 basal plate. The lines were drawn and an investigator, who was unaware of the study group assignments, randomly measured angles using a goniometer in degree (\u00b0) unit. The duration of intubation, the number of attempts, and the intubation success rate were recorded. The duration of the intubation was recorded between the passage of the intubation device through the lips and inflation of the tracheal cuff. Intubation was considered successful if the patient was intubated in less than two attempts and failed in case of more than two. Estimated from the data of Watts et al. [15] (12.9 \u00b1 2.1\u00b0 extension) and based on the assumption of \u03b1 = 0.05, \u03b2 = 0.8 to detect 15% reduction in the movement of the upper C-spine, each group would need to include at least 18 patients. Therefore 20 patients per group were planned to be enrolled due to the probability of a 10% drop-out rate. SPSS 15.0 for Windows  was used for the statistical analysis. Data are expressed as mean \u00b1 standard deviation (mean \u00b1 SD), median (min\u2013max), or numbers (n) and percentages (%). Discrete variables  were compared using the chi-square test. For numeric parameters of between-group comparisons, one-way analysis of variance (in the case of parametric test conditions) or the Kruskal\u2013Wallis tests (if parametric test conditions could not be obtained) were used. Multiple comparisons of the Kruskal\u2013Wallis test were done by Mann\u2013Whitney U test with Bonferroni correction. Analysis of variance was used for repeated measures of arterial pressure, heart rate, and oxygen saturation and the angle measurements for both between-group and intergroup comparisons. P < 0.05 was considered statistically significant.Sixty-three patients were allocated to the intervention groups. For one patient, intubation with LMA Fastrach was not possible despite adequate manipulation, even after the third attempt. Following 3 esophageal intubations, correct intubation was achieved by direct laryngoscopy and this patient was excluded from the study. In Group C, the vocal cords of 1 patient could not be visualized despite all maneuvers and the patient was also excluded. One of the patients\u2019 radiographic images could not be printed out so the angle measurement could not be analyzed in Group M. Subsequently, 20 patients per group were analyzed.2, remained stable in all groups and anesthesia was uneventful in all patients. None of the patients had hypertension or tachycardia as a response to laryngoscopy. The demographic data, Mallampati scores, and ASA physical status classification (P > 0.05) were similar in all groups (Table 1). The hemodynamic and ventilation parameters, such as arterial blood pressure, heart rate, oxygen saturation, and end-tidal COCervical alpha (\u03b1) angles in degrees at the C1/2 segment of the study patients are shown in Table 2. Baseline measurements were significantly different in Group M compared with the other groups (P = 0.004). According to the neutral baseline position, angulation of the C1/2 segment (\u03b1 angle) decreased during intubation in Group F (P = 0.042) and in Group M (P = 0.001), whereas there was no significant difference in Group C (P = 0.159). The mean degree of the change in angulation compared with the preinduction baseline values at C1/2 1.2\u00b0, 1.1\u00b0, and 2.9\u00b0 for Groups F, C, and M was not statistically significant.Cervical beta (\u03b2) angles of the studied patients are displayed in Table 3 in degrees. At the C2/3 segment (\u03b2 angle) Groups F and M similarly showed a significant increase  in cervical motion, while there was no difference in Group C during intubation compared with the neutral position. The mean change in \u03b2 angle during intubation was prominent in Groups F and M, but in Group C the extension was statistically less .The mean intubation time was 32 s in Group M, ranging from 10 to 120 s. It took the longest time to intubate patients in Group F and the shortest in Group M (P < 0.001) (Table 4). The mean duration of intubation was 98.8 and 61.0 s for the LMA Fastrach and LMA CTrach, respectively (P < 0.001). The numbers of patients intubated in the first attempt were 18 with the Macintosh laryngoscope, 15 with LMA CTrach, and 11 with LMA Fastrach while two attempts were required for 2, 5, and 5 patients, respectively (Table 4). The number of attempts significantly differed in Group F compared to Group M (P = 0.016). It required more than two attempts and was successful after repositioning the LMA Fastrach in 4 patients. The rate of successful tracheal intubation was 80% with LMA Fastrach and 100% with LMA CTrach and Macintosh laryngoscopes. Group F had the statistically lowest success rate (P = 0.009).The main result of this study is that the LMA CTrach significantly reduced extension compared to LMA Fastrach and Macintosh laryngoscopes at the C2/3 segment (\u03b2 angle) without prolonging intubation time in patients undergoing elective C-spine surgery. According to our hypothesis, both LMA Fastrach and LMA CTrach would be associated with less cervical movement than Macintosh laryngoscopes, which was at least partially confirmed with LMA CTrach for the \u03b2 angle. A study by Sawin et al. investigated the behavior of the intact C-spine during direct laryngoscopy with a Macintosh blade and proved the general assumption that a majority of cervical motions associated with laryngoscopy occur in the upper cervical region [4]. Subaxial segments (under C2) were displaced minimally. Thus, the present study was undertaken to quantify the motion of cervical segments 1/2 and 2/3. The times for radiography were chosen as once before induction and once during laryngoscopy immediately prior to insertion of the endotracheal tube or when the best view of the glottis was achieved as Hindman et al. reported maximal intubation biomechanics occurring at that stage [16]. A cadaver model of cervical instability found that supraglottic airways  caused less or equal C-spine movement compared to the conventional laryngoscopes  [9]. The authors therefore suggested that, due to the ease of training, supraglottic airways could be preferred in cervical trauma patients. Komatsu et al. tested ILMAs for controlling the airway in patients undergoing C-spine surgery who were wearing rigid cervical collars to simulate C-spine injury and found ILMAs a reasonable alternative for facilitating intubation [17]. Panjabi et al. defined the upper limits of the physiological motion as a rotation of over 20\u00b0 in the sagittal plane [18]. The maximum cervical motion at C2/3 in our study was 15\u00b0 for the Macintosh laryngoscope, 12.4\u00b0 for LMA Fastrach, and 7.6\u00b0 for LMA CTrach. In a video-fluoroscopic study, Sahin et al. observed a maximum movement of 18.5\u00b0, 16.7\u00b0, and 8.1\u00b0 during direct laryngoscopy, intubation with ILMA, and fiberoptic laryngoscopy at C1/2 [6]. The maximum cervical motion produced with LMA Fastrach in both studies was close to the angle of the Macintosh laryngoscope. However, it was still lower than the instability limits argued by Panjabi et al. [18]. Even though the extension of the motion produced by LMA CTrach in the present study seems to be less than that produced by fiber optic laryngoscopy in Sahin\u2019s study, it is actually difficult to compare the data of these similar studies. In the present study there was a significant difference in baseline angle measurements at C1/2. We do not recognize this as a study limitation because the initial position of the patient\u2019s head cannot be standardized. However, the degree of cervical extension during laryngoscopy is important. The previous literature reported extension at C1/2 produced with ILMAs ranging from 1\u00b0 to 5\u00b0 and even as high as 7.4\u00b0 . Our result is in line with this range. Nevertheless, variability of the results depends on the heterogeneity introduced by methodological and population differences of the studies and experiences of the investigators. The ability to intubate a trachea under glottis visualization with LMA CTrach was reported with higher first attempt success rates compared with LMA Fastrach [14]. Liu et al. found a 98.9% first attempt success rate for LMA CTrach in 100 patients, while Baskett et al. showed a 79.8% success rate for LMA Fastrach with the experience of 500 cases . Bilgin et al. demonstrated a first attempt success rate of intubation of 54% for ILMAs and 90% for C-Trach [13]. Our success rate, which is 75% with LMA CTrach and 55% with LMA Fastrach, is lower than those in the published literature. The diversity of these results is probably due to the methodological differences, the skills of the investigators, and the sample sizes of the mentioned studies. Nevertheless, in the current study, tracheal intubation was defined as successful only if the patient was intubated in two attempts at most with a device and the rate of successful tracheal intubation was 80% with LMA Fastrach, which statistically had the lowest rate.Secondary spinal injury during airway management is not only a result of the mechanical disruption of the unstable segments, but hypoxia is also likely to cause harm . Although both LMA CTrach and LMA Fastrach administrations may prolong intubation, they have established roles in difficult airway management since they do not interrupt ventilation . Obviously, duration of intubation lasts longer with devices that require different maneuvers compared to the laryngoscopes. In the present study, as the most familiar device for anesthetists, the Macintosh laryngoscope intubation was fastest, while the duration of intubation was significantly longer with LMA Fastrach. These findings are in line with those of Bilgin et al., who reported significantly longer mean intubation time with an ILMA compared to C-Trach and McCoy [13]. Nevertheless, none of the patients in our study presented hypoxia throughout the intubation process. Randomizing the patients without considering their Mallampati scores and evaluating airway difficulties might be a limitation of our study. If the selection of the airway device depended on the possibility of a difficult airway, a selection bias would occur for LMA CTrach over blind intubation using LMA Fastrach. Nevertheless, Mallampati scores were identical between the groups. Another possible shortcoming of the study is that it was impossible to blind the investigator to the airway device and only an independent radiologist who measured the angles was unaware of the study group assignments. Several investigators may have had different skill levels and experiences, so only one investigator performed all laryngoscopies in order to minimize any confounding effects. The third limitation is that tracheal intubations were facilitated with muscle relaxants. Sawin et al. [4] suggested that muscle relaxation using neuromuscular blockade might reduce the need for cervical extension during laryngoscopy. However, even in injury settings muscle relaxants are used to ease the insertion of the endotracheal tube. Finally, the study conclusions may be limited since this project examined only two X-ray graphics instead of dynamic fluoroscopy.In conclusion, airway management with minimal neck movement improves the success of the anesthetic management in C-spine surgery. Moreover, there are limited data that may help to understand C-spine kinetics of the patients with cervical pathologies, especially degenerative disorders requiring surgery. It is thus important to be familiar with the different intubation techniques. However, one should also be aware of their effects on cervical extension. We conclude that the reduced C-spine extension during intubation with LMA CTrach makes it a reasonable alternative compared to LMA Fastrach and Macintosh laryngoscopes in cervical surgery where cervical stability is a concern."]}
{"representative": "Wood-based TEMPO-oxidised cellulose nanofibrils (toCNF) are promising materials for biomedical applications. Cyclodextrins have ability to form inclusion complexes with hydrophobic molecules and are considered as a method to bring new functionalities to these materials. Water sorption and mechanical properties are also key properties for biomedical applications such as drug delivery and tissue engineering. In this work, we report the modification with \u03b2-cyclodextrin (\u03b2CD) of toCNF samples with different carboxyl contents viz. 756 \u00b1 4 \u00b5mol/g and 1048 \u00b1 32 \u00b5mol/g. The modification was carried out at neutral and acidic pH (2.5) to study the effect of dissociation of the carboxylic acid group. Films processed by casting/evaporation at 40 \u00b0C and cryogels processed by freeze-drying were prepared from \u03b2CD modified toCNF suspensions and compared with reference samples of unmodified toCNF. The impact of modification on water sorption and mechanical properties was assessed. It was shown that the water sorption behaviour for films is driven by adsorption, with a clear impact of the chemical makeup of the fibres . Modified toCNF cryogels (acidic pH and addition of cyclodextrins) displayed lower mechanical properties linked to the modification of the cell wall porosity structure. Esterification between \u03b2CD and toCNF under acidic conditions was performed by freeze-drying, and such cryogels exhibited a lower decrease in mechanical properties in the swollen state. These results are promising for the development of scaffold and films with controlled mechanical properties and added value due to the ability of cyclodextrin to form an inclusion complex with active principle ingredient (API) or growth factor (GF) for biomedical applications. Cellulose nanofibrils (CNFs) are high-aspect ratio nanoparticles formed by bundles of cellulose chains that are a succession of glucose subunits linked by \u03b2-1-4 glycosidic bonds. CNFs are produced from a cellulosic raw material, usually wood, the most abundant and renewable polymer available on earth. CNFs are produced by a combination of chemical/enzymatic pretreatments and mechanical treatment, usually using a homogeniser , or a grAs a natural, biodegradable, and abundant polymer with reactive surface chemistry and good biocompatibility, nanocellulose is a promising material within the medical field. In recent years, applications in wound healing ,21, drugThe utilisation of wood-based CNFs for tissue-engineering applications is encouraged by recent studies that confirmed the safety of CNFs ,28,29,30Cyclodextrins are cyclic oligosaccharides consisting of glucose subunits linked by \u03b1-1-4 glycosidic bonds. Due to their conformation, with a hydrophobic interior and a hydrophilic exterior, these macromolecules exhibit cage-like properties and can form an inclusion complex with hydrophobic compounds ,35. ThesThe aim of the present study is to modify toCNF with \u03b2CD  and to see what kind of effect this surface functionalisation has on the sorption and mechanical properties. Thus, a comparison with the same structures using unmodified toCNF is necessary. For that purpose, two suspensions of toCNF with different charge contents were prepared. Fibre modification with cyclodextrins was carried out at neutral and acidic (pH 2.5) to study the effect of the dissociation of the carboxylic acid group. Films, processed by casting/evaporation at 40 \u00b0C and cryogels, processed by freeze-drying were prepared from \u03b2CD-modified toCNF and compared with reference samples of unmodified toCNF. Water sorption was evaluated gravimetrically for both films and cryogels. The impact of density on the mechanical properties of the cryogels was assessed for cryogels obtained from unmodified toCNF and prepared by freeze-drying from suspensions at different dry matter contents for both charge contents. Compression tests in the dry and swollen state were performed on cryogels from all suspensions, and microscopic observation (SEM) was carried out to link the mechanical behaviour to the macroscopic structure of the materials.TEMPO-oxidised cellulose nanofibril suspensions were successfully produced. The amounts of carboxylic groups were determined to be 756 \u00b1 4 \u00b5mol/g and 1048 \u00b1 32 \u00b5mol/g. Films and cryogels were processed from the two different toCNF suspensions in four different conditions presented in The suspension with 756 \u00b5mol/g carboxyl content will be referred as L-toCNF in the text; hence, samples from L-toCNF will be labelled L1, L2, L3, and L4. Similarly, the suspension with 1048-\u00b5mol/g carboxyl content will be referred as H-toCNF; i.e., samples from H-toCNF will be labelled H1, H2, H3, and H4. Water sorption of films was assessed gravimetrically in a Percival climatic chamber at 25 \u00b0C and 90% relative humidity (RH) for 48 h. For each sample of both L-toCNF and H-toCNF, the sorption equilibrium was reached after approximately 4 h, which indicates that this property is not dependent of any of the variable parameters in this study. In addition, the sorption equilibrium was achieved within a relatively short period of time, with about 65% of the sorption equilibrium reached after 30 min for films cast in acidic conditions, up to around 80% for films containing cyclodextrins. The difference in sorption equilibrium observed between L-toCNF and H-toCNF can be linked to the number of carboxylic functions prone to form H-bonds with water molecules, which is higher for H-toCNF than for L-toCNF. The increase in sorption for films prepared under acidic conditions is explained by the acid form of the carboxylic groups, which is more prone to form H-bonds with water molecules than the carboxylate form at neutral pH. Finally, the decrease in sorption with the addition of cyclodextrin is thought to be due to the adsorption of \u03b2-CD on the surface of the fibres, which could decrease the amount of water bounded to the fibres. Water sorption is mainly driven by adsorption and chemical makeup-dependent. For a given drying temperature, the water sorption can be slightly tuned by varying the process parameters, which is an interesting property for drug delivery applications, where swelling and sorption properties are important for the delivery kinetics.Water sorption tests for cryogels were conducted gravimetrically. The cryogels were weighted and immersed in distilled water and then removed at different time intervals. Tissue paper was used to remove excess water prior to weighing. For both charge contents, the swelling equilibrium was reached after the first measurement at 15 min, as shown in Compression tests were carried out on cryogels of cylindrical shape. The density of each sample was determined by dividing the mass of each cryogel by its volume. The volume of the cryogels was measured from height and diameter measurements using a calliper. In each case, the compression curve can be divided into three different regions: For low-strain values, the compression stress increases linearly with the strain in the elastic domain up to the yield point. The compression modulus was calculated at a strain corresponding to half the yield stress in order to be reproducible between all samples. For strains higher than the yield point, the plastic region was reached. In this region the stress increases with the strain with significant residual deformation after unloading. For high compressive strains, the curves exhibited a sharp increase in the compressive stress, typical of a densification regime.This behaviour has previously been reported for cellulose-based foam materials ,16,18,193 (which corresponds to a relative density of 0.01). It is worth noting that the normalised compression modulus withstands a huge decrease for relative densities lower than 0.008. Density is of major importance for the mechanical behaviour of cryogels, and by controlling the density, it is possible to tailor the mechanical properties of the cryogel.Compression tests were carried out on cryogels with four different densities prepared from toCNF with both charge densities. Variations of the different properties  with the relative density are presented in Cryogels were prepared from the four compositions by freeze-drying the nanofibril suspensions. SEM images of the cross-section of the cryogels are presented in This specific orientation of porosity is due to the freeze-drying process. Indeed, freezing occurred from the bottom part of the freeze-dryer, resulting in the growth of ice in a specific direction, leading to anisotropy in the pore orientation.In addition, we can observe that the structure of the cell walls for modified toCNF cryogels presents more structural deflects (holes and folds) than the unmodified toCNF one. Compression tests were carried out on cryogels prepared from the four compositions for both charge contents. Typical stress-strain curves for each composition are presented in Unmodified toCNF cryogels (H1 and H2) exhibit clear elastomeric behaviours, with well-defined linear elastic zones up to a strain of about 0.2, followed by a compression plateau and a densification for higher strains. For modified toCNF cryogels (H3 and H4), the linear elastic zone is restrained to lower strain values, and the yield point is less marked. The deflects observed in An increase in density can be observed for cryogels cast under acidic pH and with cyclodextrins. The carboxyl content increases the interactions between the fibres in its carboxylic form, as it forms a more densely packed structure. The adsorption of cyclodextrins on the surface of the fibres also increases the interaction between fibres or creates local deflects in the fibres\u2019 arrangement. Both mechanisms impact the mechanical properties. The mechanical properties decrease when the density increases, and the elastic region in the stress-strain curve also decreases for cryogels cast under acidic pH or when containing cyclodextrins. It is also worth noting that the yield point is lower for modified cryogels (pH and cyclodextrins) than for the unmodified one and that the plateau is less pronounced. Since elasticity of foams is linked to the stretching of the cell walls and the plastic behaviour prior to densification is linked to the compression of cells, the modification of fibre-fibre interactions under acidic pH and/or with adsorption of cyclodextrin on the fibre surface is responsible for the modification of the cell wall, thus the mechanical properties. Both charge contents exhibit a similar behaviour for toCNF, toCNF pH 2.5, and toCNF 10 wt% CD, but a noticeable difference is observed for toCNF 10 wt% CD pH 2.5. For L-toCNF, the density decreases between pH 2.5 and 10 wt% CD pH 2.5, while the normalised compression modulus and the maximum stress at deformation are quite similar. For H-toCNF, the density increases between pH 2.5 and 10 wt% CD pH 2.5, while the normalised compression modulus and the maximum stress at 70% deformation decrease. Under these conditions (10 wt% CD and pH 2.5), esterification occurred between the carboxylic acid of the toCNF and hydroxyl groups of cyclodextrins, as evidenced by the attenuated total reflectance-Fourier transform infrared (ATR-FTIR) spectra shown in \u22121 corresponds to the carboxylate ions present on the surface of the fibres introduced during TEMPO-mediated oxidation. For toCNF 10wt% CD pH 2.5, a peak at 1750 cm\u22121 can be observed which corresponds to the ester groups. The presence of this esterification peak only for toCNF 10wt% CD pH 2.5 indicates that the esterification reaction occurred between the hydroxyl groups of the cyclodextrins and the carboxylic acid groups of toCNF under acidic pH, suggesting that the lyophilisation process allows the reaction by the removal of water. Considering the respective charge contents for L-toCNF and H-toCNF, the efficiency of esterification might be higher for H-toCNF, which can explain the decrease in mechanical properties observed for H4.The peak observed at 1600 cmCryogels were immersed in water for 1 h prior to the experiment, and tissue paper was used to remove excess water before compression. The changes in mechanical properties between the dry and swollen states are summarised in Since no clear elastic deformation zone can be observed for swollen cryogels, the compression modulus was calculated at a low strain (< 0.1) for comparison with dry cryogels. The decrease in mechanical properties is more significant for H-toCNF , which can be explained by the higher charge content, making the fibres more sensitive to the adsorption of water molecules. It is also worth noting that the decrease in mechanical properties is reduced for H4 in comparison with L4, with respectively \u221249% and \u221277% decreases in the compression modulus compared to their dry state. This behaviour could be explained by the esterification between cyclodextrin and toCNF, cross-linking fibres, and making the structure less sensitive to water ad/absorption. Esterification of \u03b2CD with toCNF under acidic conditions by freeze-drying was proven. Nevertheless, some questions remain about the yield of grafting and the adsorption mechanism between unbound cyclodextrins and toCNF. Given the chemical similarity between toCNF and \u03b2CD, direct characterisation and quantification of grafting seems impossible, as a cyclodextrin with several hydroxyl functions is likely to bind with the carboxylic acid of toCNF. Nevertheless, the presence of multiple hydroxyl functions on both toCNF and \u03b2CD indicates a strong adsorption between these two components. However, some cyclodextrins might be trapped in the ice phase during the freezing process and, therefore, are not available for an esterification reaction during the freeze-drying phase. In order to better quantify this adsorption and to be able to confirm that no material will be released from the materials produced, further studies, in particular with the means of Quartz Crystal Microbalance with Dissipation monitoring (QCM-D) and Isothermal Titration Calorimetry (ITC), will be conducted. Additionally, a method adapted from  will be The compression modulus for swollen modified toCNF cryogels ranges between 6 and 9 kPa, i.e., in the range of mechanical stiffness of muscle tissue, and the high porosities obtained , which are mandatory to promote a good vascularisation, the diffusion of nutrients to the cells, and tissue growth, made this structurally suited for tissue engineering applications. Further studies will be focused on the mechanical properties of such materials under successive stress. Nevertheless, to confirm the potential for tissue-engineering applications, cytotoxicity and degradation studies need to be done in further work. However, \u03b2CD toCNF materials could be of a great interest for other applications, such as filtration or depollution, using cyclodextrins to capture molecules of interest rather than release them.A mixture of bleached and never-dried spruce (picea abies ca. 75%) and pine  cellulose pulp from S\u00f6dra  was used as raw material. All chemicals used in this study were of laboratory-grade quality purchased from Sigma-Aldrich, St. Louis, MO, USA.TEMPO-oxidised cellulose nanofibrils were produced according to a protocol adapted from . Never-dThe carboxyl group content was determined by conductometric titration as described in previous studies e.g., ,32,65). ,65. 32,6Dry toCNF (0.25 g) was weighed and diluted with water to a total volume of 50 mL. The suspension was dispersed for 2 min at 7000 rpm with an UltraTurrax , at room temperature. \u03b2CD (0.025 g) and 0.1-M HCl (2 mL) were added to the relevant samples. The suspensions were magnetically stirred for 1 h and placed in an ultra-sonic bath for 3 min. The suspension was then cast in petri dishes (9-cm diameter) and stored in an oven at 40 \u00b0C for 18 h. The resulting films were stored in closed petri dishes at room temperature.Impact of pH, cyclodextrin, and comparison dry/swollen: Fifty millilitres of 0.8 wt% toCNF suspensions were prepared and dispersed 2 min at 7000 rpm with an UltraTurrax. \u03b2CD (0.04 g) and 0.1-M HCl (3 mL) were added if required. The suspensions were magnetically stirred for 1 h and placed in an ultra-sonic bath for 3 min. The suspensions were poured into a 24-well plate (3 mL per well) and freeze-dried for 24 h at \u221220 \u00b0C and 0.3 mbar . The resulting cryogels were stored in closed well plates.\u00ae, Osterode am Harz, Germany).Impact of density: Fifty millilitres of L-toCNF and H-toCNF suspensions at 1 wt%, 0.8 wt%, 0.6 w%, and 0.4 wt% were prepared and dispersed for 2 min at 7000 rpm with an UltraTurrax. The suspensions were magnetically stirred for 1 h and placed in an ultra-sonic bath for 3 min. The suspensions were then poured into a 24-well plate (3mL per well) and put in a freezer at \u221220 \u00b0C for 24 h before freeze-drying  and the weight after a certain time t (mt), according to Equation (1):Water sorption tests on films were carried out gravimetrically in a Percival climatic chamber at 25 \u00b0C and 90% RH (relative humidity). The samples were weighted every hour at the beginning of the experiment and at selected times thereafter. Water sorption experiments were conducted after 48 h, with at least 3 replicates for each sample. The samples were put in a desiccator for 16 h prior to the experiment. The water sorption was characterised by the weight change between the initial sample weight .\u00ae . The concentration of the suspension was adjusted to 10\u22123 wt% by diluting the CNF dispersion using the high shear mixer Ultra-Turrax. A drop of this suspension was deposited on a freshly cleaved mica plate before drying overnight under a fume hood at room temperature. The acquisition was performed in tapping mode using a silica-coated cantilever . Zones of 1.1*1.1 \u03bcm2 were analysed.Atomic force microscopy images were recorded on a Dimension iconScanning electron microscopy images were performed with ESEM . Film and cryogel cross-sections were cut with a razor blade. SEM observation was carried out on cross-sections after carbon sputter coating of 5 nm, with a tension of 10 kV and a spot size of 3.5. The working distance was set between 9.5 mm and 11.5 mm depending on the sample.For both microscopy techniques, at least 5 different images were performed to check the consistency in various zones of the sample, and the most representatives were selected for the discussion.Impact of density: Compression tests were performed using a TA Instruments RSA 3  dynamic mechanical analyser fitted with a 100-N load cell. Samples prepared as cylinders were individually measured and compressed with a crosshead speed of 0.1 mm/s at room temperature. At the least, triplicates were performed, and the average is presented.Impact of pH, cyclodextrin, and comparison dry/swollen: Compression tests were performed with a Stable Micro Systems TA-XT2 texture-analyser , equipped with a P/35 probe and with a crosshead speed of 0.1 mm/s, as previously described by Heggset et al., 2018 .c, where \u03c1c is the density of cellulose, 1.5 g/cm3 [A minimum of 6 cryogels were tested for each sample. The compression modulus was calculated in the elastic region at half the strain of the beginning of the plateau region, and the stress at 70% strain was directly read from the data. The normalised compression modulus was calculated by dividing the compression modulus by the cryogel density. The cryogel density \u03c1 was determined by dividing the mass of each cryogel by its volume. The volume of produced cryogels was measured from height and diameter measurements using a calliper. For each sample, the two extreme values were removed. The relative density of the cryogels was calculated from the ratio \u03c1/\u03c1.5 g/cm3 . The por\u22121, with 16 scans and a resolution of 4 cm\u22121. Since this technique is used to determine the possible esterification between the cyclodextrins and the toCNF, and given the proximity between the carboxylic peak and the ester peak , each cryogel was dipped in 0.05 M NaOH for 10 s to convert carboxylic acid groups to carboxylate groups (1600 cm\u22121) and dried in the oven for 30 min prior to analysis. As the control sample, the neat samples and neat samples after 30 min drying in the oven were also analysed to ensure that esterification was only due to the freeze-drying process. At least 5 different zones of the sample were analysed, and the most representative spectra were used for discussion.Infrared spectra were recorded in attenuated total reflectance (ATR) mode, using a Perkin Elmer Spectrum 65 . Spectra were recorded between 4000 and 600 cmIn this work, films and cryogels of \u03b2-cyclodextrin-modified TEMPO-oxidised cellulose nanofibrils were produced. Water sorption analysis and mechanical characterisation were conducted on both modified and unmodified materials under dry and wet conditions. Two unmodified nanofibrils suspensions were prepared with different charge contents (750 \u00b5mol/g and 1050 \u00b5mol/g), and modification was carried out under neutral and acidic conditions. The sorption equilibrium was reached after 4 h for all films tested, but the charge content and acidic casting pH were shown to increase the water sorption, while cyclodextrins decreased it. Density, process pH, and the addition of cyclodextrins had major impacts on the mechanical properties, related to the modification of the cell wall structure. Finally, covalent esterification binding between \u03b2-cyclodextrin and toCNF under acidic pH by freeze-drying was achieved and had an interesting impact on the mechanical properties in the swollen state. This study is a step towards the production of mechanically tailored cryogels containing cyclodextrin, making them promising materials for the sustained delivery of active principle ingredients.", "texts": ["Wood-based TEMPO-oxidised cellulose nanofibrils (toCNF) are promising materials for biomedical applications. Cyclodextrins have ability to form inclusion complexes with hydrophobic molecules and are considered as a method to bring new functionalities to these materials. Water sorption and mechanical properties are also key properties for biomedical applications such as drug delivery and tissue engineering. In this work, we report the modification with \u03b2-cyclodextrin (\u03b2CD) of toCNF samples with different carboxyl contents viz. 756 \u00b1 4 \u00b5mol/g and 1048 \u00b1 32 \u00b5mol/g. The modification was carried out at neutral and acidic pH (2.5) to study the effect of dissociation of the carboxylic acid group. Films processed by casting/evaporation at 40 \u00b0C and cryogels processed by freeze-drying were prepared from \u03b2CD modified toCNF suspensions and compared with reference samples of unmodified toCNF. The impact of modification on water sorption and mechanical properties was assessed. It was shown that the water sorption behaviour for films is driven by adsorption, with a clear impact of the chemical makeup of the fibres . Modified toCNF cryogels (acidic pH and addition of cyclodextrins) displayed lower mechanical properties linked to the modification of the cell wall porosity structure. Esterification between \u03b2CD and toCNF under acidic conditions was performed by freeze-drying, and such cryogels exhibited a lower decrease in mechanical properties in the swollen state. These results are promising for the development of scaffold and films with controlled mechanical properties and added value due to the ability of cyclodextrin to form an inclusion complex with active principle ingredient (API) or growth factor (GF) for biomedical applications. Cellulose nanofibrils (CNFs) are high-aspect ratio nanoparticles formed by bundles of cellulose chains that are a succession of glucose subunits linked by \u03b2-1-4 glycosidic bonds. CNFs are produced from a cellulosic raw material, usually wood, the most abundant and renewable polymer available on earth. CNFs are produced by a combination of chemical/enzymatic pretreatments and mechanical treatment, usually using a homogeniser , or a grAs a natural, biodegradable, and abundant polymer with reactive surface chemistry and good biocompatibility, nanocellulose is a promising material within the medical field. In recent years, applications in wound healing ,21, drugThe utilisation of wood-based CNFs for tissue-engineering applications is encouraged by recent studies that confirmed the safety of CNFs ,28,29,30Cyclodextrins are cyclic oligosaccharides consisting of glucose subunits linked by \u03b1-1-4 glycosidic bonds. Due to their conformation, with a hydrophobic interior and a hydrophilic exterior, these macromolecules exhibit cage-like properties and can form an inclusion complex with hydrophobic compounds ,35. ThesThe aim of the present study is to modify toCNF with \u03b2CD  and to see what kind of effect this surface functionalisation has on the sorption and mechanical properties. Thus, a comparison with the same structures using unmodified toCNF is necessary. For that purpose, two suspensions of toCNF with different charge contents were prepared. Fibre modification with cyclodextrins was carried out at neutral and acidic (pH 2.5) to study the effect of the dissociation of the carboxylic acid group. Films, processed by casting/evaporation at 40 \u00b0C and cryogels, processed by freeze-drying were prepared from \u03b2CD-modified toCNF and compared with reference samples of unmodified toCNF. Water sorption was evaluated gravimetrically for both films and cryogels. The impact of density on the mechanical properties of the cryogels was assessed for cryogels obtained from unmodified toCNF and prepared by freeze-drying from suspensions at different dry matter contents for both charge contents. Compression tests in the dry and swollen state were performed on cryogels from all suspensions, and microscopic observation (SEM) was carried out to link the mechanical behaviour to the macroscopic structure of the materials.TEMPO-oxidised cellulose nanofibril suspensions were successfully produced. The amounts of carboxylic groups were determined to be 756 \u00b1 4 \u00b5mol/g and 1048 \u00b1 32 \u00b5mol/g. Films and cryogels were processed from the two different toCNF suspensions in four different conditions presented in The suspension with 756 \u00b5mol/g carboxyl content will be referred as L-toCNF in the text; hence, samples from L-toCNF will be labelled L1, L2, L3, and L4. Similarly, the suspension with 1048-\u00b5mol/g carboxyl content will be referred as H-toCNF; i.e., samples from H-toCNF will be labelled H1, H2, H3, and H4. Water sorption of films was assessed gravimetrically in a Percival climatic chamber at 25 \u00b0C and 90% relative humidity (RH) for 48 h. For each sample of both L-toCNF and H-toCNF, the sorption equilibrium was reached after approximately 4 h, which indicates that this property is not dependent of any of the variable parameters in this study. In addition, the sorption equilibrium was achieved within a relatively short period of time, with about 65% of the sorption equilibrium reached after 30 min for films cast in acidic conditions, up to around 80% for films containing cyclodextrins. The difference in sorption equilibrium observed between L-toCNF and H-toCNF can be linked to the number of carboxylic functions prone to form H-bonds with water molecules, which is higher for H-toCNF than for L-toCNF. The increase in sorption for films prepared under acidic conditions is explained by the acid form of the carboxylic groups, which is more prone to form H-bonds with water molecules than the carboxylate form at neutral pH. Finally, the decrease in sorption with the addition of cyclodextrin is thought to be due to the adsorption of \u03b2-CD on the surface of the fibres, which could decrease the amount of water bounded to the fibres. Water sorption is mainly driven by adsorption and chemical makeup-dependent. For a given drying temperature, the water sorption can be slightly tuned by varying the process parameters, which is an interesting property for drug delivery applications, where swelling and sorption properties are important for the delivery kinetics.Water sorption tests for cryogels were conducted gravimetrically. The cryogels were weighted and immersed in distilled water and then removed at different time intervals. Tissue paper was used to remove excess water prior to weighing. For both charge contents, the swelling equilibrium was reached after the first measurement at 15 min, as shown in Compression tests were carried out on cryogels of cylindrical shape. The density of each sample was determined by dividing the mass of each cryogel by its volume. The volume of the cryogels was measured from height and diameter measurements using a calliper. In each case, the compression curve can be divided into three different regions: For low-strain values, the compression stress increases linearly with the strain in the elastic domain up to the yield point. The compression modulus was calculated at a strain corresponding to half the yield stress in order to be reproducible between all samples. For strains higher than the yield point, the plastic region was reached. In this region the stress increases with the strain with significant residual deformation after unloading. For high compressive strains, the curves exhibited a sharp increase in the compressive stress, typical of a densification regime.This behaviour has previously been reported for cellulose-based foam materials ,16,18,193 (which corresponds to a relative density of 0.01). It is worth noting that the normalised compression modulus withstands a huge decrease for relative densities lower than 0.008. Density is of major importance for the mechanical behaviour of cryogels, and by controlling the density, it is possible to tailor the mechanical properties of the cryogel.Compression tests were carried out on cryogels with four different densities prepared from toCNF with both charge densities. Variations of the different properties  with the relative density are presented in Cryogels were prepared from the four compositions by freeze-drying the nanofibril suspensions. SEM images of the cross-section of the cryogels are presented in This specific orientation of porosity is due to the freeze-drying process. Indeed, freezing occurred from the bottom part of the freeze-dryer, resulting in the growth of ice in a specific direction, leading to anisotropy in the pore orientation.In addition, we can observe that the structure of the cell walls for modified toCNF cryogels presents more structural deflects (holes and folds) than the unmodified toCNF one. Compression tests were carried out on cryogels prepared from the four compositions for both charge contents. Typical stress-strain curves for each composition are presented in Unmodified toCNF cryogels (H1 and H2) exhibit clear elastomeric behaviours, with well-defined linear elastic zones up to a strain of about 0.2, followed by a compression plateau and a densification for higher strains. For modified toCNF cryogels (H3 and H4), the linear elastic zone is restrained to lower strain values, and the yield point is less marked. The deflects observed in An increase in density can be observed for cryogels cast under acidic pH and with cyclodextrins. The carboxyl content increases the interactions between the fibres in its carboxylic form, as it forms a more densely packed structure. The adsorption of cyclodextrins on the surface of the fibres also increases the interaction between fibres or creates local deflects in the fibres\u2019 arrangement. Both mechanisms impact the mechanical properties. The mechanical properties decrease when the density increases, and the elastic region in the stress-strain curve also decreases for cryogels cast under acidic pH or when containing cyclodextrins. It is also worth noting that the yield point is lower for modified cryogels (pH and cyclodextrins) than for the unmodified one and that the plateau is less pronounced. Since elasticity of foams is linked to the stretching of the cell walls and the plastic behaviour prior to densification is linked to the compression of cells, the modification of fibre-fibre interactions under acidic pH and/or with adsorption of cyclodextrin on the fibre surface is responsible for the modification of the cell wall, thus the mechanical properties. Both charge contents exhibit a similar behaviour for toCNF, toCNF pH 2.5, and toCNF 10 wt% CD, but a noticeable difference is observed for toCNF 10 wt% CD pH 2.5. For L-toCNF, the density decreases between pH 2.5 and 10 wt% CD pH 2.5, while the normalised compression modulus and the maximum stress at deformation are quite similar. For H-toCNF, the density increases between pH 2.5 and 10 wt% CD pH 2.5, while the normalised compression modulus and the maximum stress at 70% deformation decrease. Under these conditions (10 wt% CD and pH 2.5), esterification occurred between the carboxylic acid of the toCNF and hydroxyl groups of cyclodextrins, as evidenced by the attenuated total reflectance-Fourier transform infrared (ATR-FTIR) spectra shown in \u22121 corresponds to the carboxylate ions present on the surface of the fibres introduced during TEMPO-mediated oxidation. For toCNF 10wt% CD pH 2.5, a peak at 1750 cm\u22121 can be observed which corresponds to the ester groups. The presence of this esterification peak only for toCNF 10wt% CD pH 2.5 indicates that the esterification reaction occurred between the hydroxyl groups of the cyclodextrins and the carboxylic acid groups of toCNF under acidic pH, suggesting that the lyophilisation process allows the reaction by the removal of water. Considering the respective charge contents for L-toCNF and H-toCNF, the efficiency of esterification might be higher for H-toCNF, which can explain the decrease in mechanical properties observed for H4.The peak observed at 1600 cmCryogels were immersed in water for 1 h prior to the experiment, and tissue paper was used to remove excess water before compression. The changes in mechanical properties between the dry and swollen states are summarised in Since no clear elastic deformation zone can be observed for swollen cryogels, the compression modulus was calculated at a low strain (< 0.1) for comparison with dry cryogels. The decrease in mechanical properties is more significant for H-toCNF , which can be explained by the higher charge content, making the fibres more sensitive to the adsorption of water molecules. It is also worth noting that the decrease in mechanical properties is reduced for H4 in comparison with L4, with respectively \u221249% and \u221277% decreases in the compression modulus compared to their dry state. This behaviour could be explained by the esterification between cyclodextrin and toCNF, cross-linking fibres, and making the structure less sensitive to water ad/absorption. Esterification of \u03b2CD with toCNF under acidic conditions by freeze-drying was proven. Nevertheless, some questions remain about the yield of grafting and the adsorption mechanism between unbound cyclodextrins and toCNF. Given the chemical similarity between toCNF and \u03b2CD, direct characterisation and quantification of grafting seems impossible, as a cyclodextrin with several hydroxyl functions is likely to bind with the carboxylic acid of toCNF. Nevertheless, the presence of multiple hydroxyl functions on both toCNF and \u03b2CD indicates a strong adsorption between these two components. However, some cyclodextrins might be trapped in the ice phase during the freezing process and, therefore, are not available for an esterification reaction during the freeze-drying phase. In order to better quantify this adsorption and to be able to confirm that no material will be released from the materials produced, further studies, in particular with the means of Quartz Crystal Microbalance with Dissipation monitoring (QCM-D) and Isothermal Titration Calorimetry (ITC), will be conducted. Additionally, a method adapted from  will be The compression modulus for swollen modified toCNF cryogels ranges between 6 and 9 kPa, i.e., in the range of mechanical stiffness of muscle tissue, and the high porosities obtained , which are mandatory to promote a good vascularisation, the diffusion of nutrients to the cells, and tissue growth, made this structurally suited for tissue engineering applications. Further studies will be focused on the mechanical properties of such materials under successive stress. Nevertheless, to confirm the potential for tissue-engineering applications, cytotoxicity and degradation studies need to be done in further work. However, \u03b2CD toCNF materials could be of a great interest for other applications, such as filtration or depollution, using cyclodextrins to capture molecules of interest rather than release them.A mixture of bleached and never-dried spruce (picea abies ca. 75%) and pine  cellulose pulp from S\u00f6dra  was used as raw material. All chemicals used in this study were of laboratory-grade quality purchased from Sigma-Aldrich, St. Louis, MO, USA.TEMPO-oxidised cellulose nanofibrils were produced according to a protocol adapted from . Never-dThe carboxyl group content was determined by conductometric titration as described in previous studies e.g., ,32,65). ,65. 32,6Dry toCNF (0.25 g) was weighed and diluted with water to a total volume of 50 mL. The suspension was dispersed for 2 min at 7000 rpm with an UltraTurrax , at room temperature. \u03b2CD (0.025 g) and 0.1-M HCl (2 mL) were added to the relevant samples. The suspensions were magnetically stirred for 1 h and placed in an ultra-sonic bath for 3 min. The suspension was then cast in petri dishes (9-cm diameter) and stored in an oven at 40 \u00b0C for 18 h. The resulting films were stored in closed petri dishes at room temperature.Impact of pH, cyclodextrin, and comparison dry/swollen: Fifty millilitres of 0.8 wt% toCNF suspensions were prepared and dispersed 2 min at 7000 rpm with an UltraTurrax. \u03b2CD (0.04 g) and 0.1-M HCl (3 mL) were added if required. The suspensions were magnetically stirred for 1 h and placed in an ultra-sonic bath for 3 min. The suspensions were poured into a 24-well plate (3 mL per well) and freeze-dried for 24 h at \u221220 \u00b0C and 0.3 mbar . The resulting cryogels were stored in closed well plates.\u00ae, Osterode am Harz, Germany).Impact of density: Fifty millilitres of L-toCNF and H-toCNF suspensions at 1 wt%, 0.8 wt%, 0.6 w%, and 0.4 wt% were prepared and dispersed for 2 min at 7000 rpm with an UltraTurrax. The suspensions were magnetically stirred for 1 h and placed in an ultra-sonic bath for 3 min. The suspensions were then poured into a 24-well plate (3mL per well) and put in a freezer at \u221220 \u00b0C for 24 h before freeze-drying  and the weight after a certain time t (mt), according to Equation (1):Water sorption tests on films were carried out gravimetrically in a Percival climatic chamber at 25 \u00b0C and 90% RH (relative humidity). The samples were weighted every hour at the beginning of the experiment and at selected times thereafter. Water sorption experiments were conducted after 48 h, with at least 3 replicates for each sample. The samples were put in a desiccator for 16 h prior to the experiment. The water sorption was characterised by the weight change between the initial sample weight .\u00ae . The concentration of the suspension was adjusted to 10\u22123 wt% by diluting the CNF dispersion using the high shear mixer Ultra-Turrax. A drop of this suspension was deposited on a freshly cleaved mica plate before drying overnight under a fume hood at room temperature. The acquisition was performed in tapping mode using a silica-coated cantilever . Zones of 1.1*1.1 \u03bcm2 were analysed.Atomic force microscopy images were recorded on a Dimension iconScanning electron microscopy images were performed with ESEM . Film and cryogel cross-sections were cut with a razor blade. SEM observation was carried out on cross-sections after carbon sputter coating of 5 nm, with a tension of 10 kV and a spot size of 3.5. The working distance was set between 9.5 mm and 11.5 mm depending on the sample.For both microscopy techniques, at least 5 different images were performed to check the consistency in various zones of the sample, and the most representatives were selected for the discussion.Impact of density: Compression tests were performed using a TA Instruments RSA 3  dynamic mechanical analyser fitted with a 100-N load cell. Samples prepared as cylinders were individually measured and compressed with a crosshead speed of 0.1 mm/s at room temperature. At the least, triplicates were performed, and the average is presented.Impact of pH, cyclodextrin, and comparison dry/swollen: Compression tests were performed with a Stable Micro Systems TA-XT2 texture-analyser , equipped with a P/35 probe and with a crosshead speed of 0.1 mm/s, as previously described by Heggset et al., 2018 .c, where \u03c1c is the density of cellulose, 1.5 g/cm3 [A minimum of 6 cryogels were tested for each sample. The compression modulus was calculated in the elastic region at half the strain of the beginning of the plateau region, and the stress at 70% strain was directly read from the data. The normalised compression modulus was calculated by dividing the compression modulus by the cryogel density. The cryogel density \u03c1 was determined by dividing the mass of each cryogel by its volume. The volume of produced cryogels was measured from height and diameter measurements using a calliper. For each sample, the two extreme values were removed. The relative density of the cryogels was calculated from the ratio \u03c1/\u03c1.5 g/cm3 . The por\u22121, with 16 scans and a resolution of 4 cm\u22121. Since this technique is used to determine the possible esterification between the cyclodextrins and the toCNF, and given the proximity between the carboxylic peak and the ester peak , each cryogel was dipped in 0.05 M NaOH for 10 s to convert carboxylic acid groups to carboxylate groups (1600 cm\u22121) and dried in the oven for 30 min prior to analysis. As the control sample, the neat samples and neat samples after 30 min drying in the oven were also analysed to ensure that esterification was only due to the freeze-drying process. At least 5 different zones of the sample were analysed, and the most representative spectra were used for discussion.Infrared spectra were recorded in attenuated total reflectance (ATR) mode, using a Perkin Elmer Spectrum 65 . Spectra were recorded between 4000 and 600 cmIn this work, films and cryogels of \u03b2-cyclodextrin-modified TEMPO-oxidised cellulose nanofibrils were produced. Water sorption analysis and mechanical characterisation were conducted on both modified and unmodified materials under dry and wet conditions. Two unmodified nanofibrils suspensions were prepared with different charge contents (750 \u00b5mol/g and 1050 \u00b5mol/g), and modification was carried out under neutral and acidic conditions. The sorption equilibrium was reached after 4 h for all films tested, but the charge content and acidic casting pH were shown to increase the water sorption, while cyclodextrins decreased it. Density, process pH, and the addition of cyclodextrins had major impacts on the mechanical properties, related to the modification of the cell wall structure. Finally, covalent esterification binding between \u03b2-cyclodextrin and toCNF under acidic pH by freeze-drying was achieved and had an interesting impact on the mechanical properties in the swollen state. This study is a step towards the production of mechanically tailored cryogels containing cyclodextrin, making them promising materials for the sustained delivery of active principle ingredients."]}
{"representative": "Ecklonia cava and E. cava extract (ECE) decreases blood pressure by reducing inflammation; however, it has not been elucidated whether DK or ECE modulates the Treg/Th17 balance, changes the gut epithelial barrier, or decreases endothelial cell dysfunction. We evaluated the effects of ECE and DK on gut barrier and the Treg/Th17 balance in the intestine and aorta, with regard to endothelial dysfunction, using the spontaneously hypertensive rat (SHR) model. The level of Th17 cells increased and that of Treg cells decreased in the intestine of SHRs compared to normotensive Wistar Kyoto (WKY) rat. These changes were attenuated by ECE or DK treatment. Additionally, the serum IL-17A level increased in SHRs more than WKY; this was decreased by ECE or DK treatment. The level of Treg cells decreased and that of Th17 cells increased in the aorta of SHRs. These changes were attenuated by ECE or DK treatment. The NF-\u03baB and IL-6 levels were increased in SHRs, but these changes were reversed by ECE or DK treatment. Endothelial cell dysfunction, which was evaluated using peNOS/eNOS, nitrate/nitrite ratio, and NADPH oxidase activity, increased in the aorta of SHRs, but was decreased by ECE or DK treatment. The Treg/Th17 balance in the intestine and aorta of SHRs was attenuated and endothelial cell dysfunction was attenuated through the Th17/NF-\u03baB/IL-6 pathway by ECE or DK. Disruptions of the Treg/Th17 cell balance and gut barrier function are associated with endothelial dysfunction. Dieckol (DK) obtained from  As a physical barrier, the gut epithelial barrier, composed of epithelium, mucus lining, and junctional proteins, is involved in modulating the absorption of nutrients and limiting the passage of pathogens or unwanted molecules into the systemic circulation . StructuStudies have shown that gut permeability, which was evaluated by measuring fluorescein isothiocyanate (FITC)-dextran in the plasma, was increased in adult spontaneously hypertensive rat (SHR) compared with that in age-matched normotensive Wistar Kyoto (WKY) rat ,6. In ad+ T helper subset that produces interleukin (IL)-17A, which aggravates tissue inflammation [T helper 17 (Th17) cells are a unique CD4ammation ,9. Underammation , are invammation ,12. Howeammation .IL-17A binds to IL-17 receptor A (IL-17RA) and activates various signal pathways related to inflammation, such as nuclear factor-\u03baB (NF-\u03baB) . For NF-Modulation of Th17/Tregs balance by increasing Treg cells restored tight junction of intestinal epithelial cell barrier in the inflammatory bowel disease . It is kSerum/glucocorticoid-regulated kinase 1 (SGK1) is essential for regulating Th17/Treg balance . IL-23 sEcklonia cava, is known to exert antihypertensive effects by inhibiting angiotensin 1-converting enzyme [E. cava extract (ECE) attenuated endothelial cell dysfunction by reducing the inflammation of perivascular fat tissue [Meanwhile, dieckol (DK), a phlorotannin present in g enzyme . Previout tissue . AlthougE. cava was obtained from Aqua Green Technology Co., Ltd. . For extraction, E. cava was washed and air-dried at room temperature for 48 h, after which the blades were ground and 50% ethanol was added, followed by incubation at 85 \u00b0C for 12 h. ECE was filtered, concentrated, sterilized by heating to \u226585 \u00b0C for 40\u201360 min, and then spray-dried. DK, one of the representative phlorotannins present in ECE, was isolated using centrifugal partition chromatography (CPC). CPC was performed using a two-phase solvent system comprising water/ethyl acetate/methyl alcohol/n-hexane . The organic stationary phase was filled in the CPC column, followed by pumping of the mobile phase into the column in descending mode at the same flow rate used for separation (2 mL/min). We finally confirmed that the purity of the DK used in the study was 93.58% [s 93.58% .n = 25, n = 5 for each of the 5 groups) and WKY rats  were obtained from Orient Bio  and housed at a constant temperature of approximately 23 \u00b0C, relative humidity of 50%, and a dark/light cycle of 12/12 h. The rats were acclimated to the conditions for 1 week. The rats were then randomly categorized into six groups. For 4 weeks, the rats were orally administered drinking water , and SHRs were orally administered ECE  or DK . At the end of the four-week study period, blood pressure of all rats was measured by using a noninvasive tail-cuff CODA system  [Male SHRs  ,35. Afteg for 15 min at 4 \u00b0C. The aqueous phase was collected, placed in cleaned tubes, mixed with 0.5 mL of isopropanol, and centrifuged at the same conditions. The supernatant was discarded, leaving only the RNA pellet that was then washed with 70% ethanol and dissolved in 50 \u00b5L of diethyl pyrocarbonate-treated water. The isolated RNA was synthesized with cDNA using a Prime Script 1st strand cDNA Synthesis Kit according to the manufacturer\u2019s instructions .The rat intestine and aorta were homogenized in ice using a disposable pestle in 1 mL of RNisol , and homogenates were added to 0.2 mL of chloroform, mixed, and centrifuged at 12,000\u00d7 TM software [Quantitative real-time polymerase chain reaction (qRT-PCR) was performed using cDNA synthesis by the CFX384 TouchTM Real-Time PCR detection system. Two hundred nanograms of cDNA, 5 \u03bcL of SYBR premix , 0.4 \u03bcM forward and reverse primers  [Staining with PAS was used to determine the intestinal mucosa with goblet cells in absorptive columnar epithelium. Deparaffined intestine tissue sections were stained with using the PAS staining kit . The intestinal tissue slides were oxidized in 1% periodic acid solution  for 5 min, rinsed in distilled water, and placed in Schiff reagent  for 20 min at room temperature. Nuclei were stained with Harris\u2019 hematoxylin , and the slides were cover-slipped using a mounting medium and observed under an optical microscope . The number of PAS-positive goblet cells per \u03bcmMD, USA) . MorphomH&E staining was used for determining the intestinal pathologic changes including villi length and tunica muscularis thickness. The intestinal tissue slides were incubated with hematoxylin  for 1 min, rinsed in distilled water for 10 min, and placed in eosin Y solution  for 1 min at room temperature. Nuclei were detected with blue color and cytoplasm was detected with light pink, and the completed slides observed under an optical microscope . The villi length and tunica muscularis thickness were measured by ImageJ  . Histolog for 10 min and the supernatant was transferred to a new tube. The transparent serum specimens obtained were stored in a freezer at \u221280 \u00b0C.To measure the serum IL-17A and IL-10 levels, 1 mL of blood was centrifuged and incubated in serum separator tubes  for 30 min. Samples were then centrifuged at 2000\u00d7 The 96-well microplates were coated with anti-IL-17A and anti-IL-10 antibodies diluted in 100 nM carbonate and bicarbonate mixed buffer, adjusted to pH 9.6, and incubated overnight at 4 \u00b0C. The microplates were then washed with PBS containing 0.1% Triton X-100 (TPBS). The remaining protein-binding sites were then blocked using 5% skim milk for 6 h at room temperature . After w+ ratio  in the aorta of each group were determined using the appropriate kit, in accordance with the manufacturer\u2019s instructions. Nitrate/nitrite levels  and NADP/NADPHNonparametric tests were performed in this study. The Kruskal\u2013Wallis test was used to determine the significance of differences among the WKY/water, SHR/water, and SHR/ECE150 groups. If significant difference was confirmed by Kruskal\u2013Wallis, multiple comparison was performed with the Mann\u2013Whitney U test. Results were presented as mean \u00b1 SD, and statistical significance was accepted as follows: *, versus WKY/water; $, versus SHR/water; and #, versus SHR/ECE150. Statistical analysis was performed using SPSS version 22 .The mRNA expression level of a Th17 cell marker (ROR\u03b3t) in the intestine of SHRs was higher than that in WKY rats, but it was decreased following treatment with either ECE or DK A. The deThe expression level of IL-17A in the intestine of SHRs was significantly higher than that in WKY rats C,D. It wThe expression level of zonula occludens-1 (ZO-1), a tight junction protein of the gut barrier, was evaluated to confirm gut barrier integrity A,B. The The number of goblet cells in the PAS-stained intestine was decreased in SHRs compared with that in WKY rats C,D. It wThe thickness of tunica muscularis was increased in SHRs compared with that in WKY rats E,F. It wThe increasing effect was most prominent in the 100 and 150 mg/kg ECE treatment. The mRNA expression level of SGK1 in the intestine of SHRs was significantly increased, which was in turn significantly decreased following the administration of 100 and 150 mg/kg ECE and DK H. The deThe serum level of IL-17A in SHRs was significantly higher than that in WKY rats. This level was decreased following the administration of either ECE or DK). The decreasing effect was most prominent in the 150 mg/kg ECE treatment . The serum level of IL-10 in SHRs was significantly lower than that in WKY rats, but it was significantly increased following the administration of either ECE or DK. The increasing effect was most prominent in the 150 mg/kg ECE treatment .The mRNA expression of ROR\u03b3t (a marker of Th17) in the aorta of SHRs was increased compared with that in WKY rats A. HoweveThe expression level of IL-17A in the aorta of SHRs was significantly increased compared with that in WKY rats C,D. It wThe expression levels of ACT and TRAF6, which are essential factors for IL-17A to initiate the upregulation of NF-\u03baB, was significantly higher in the aorta of SHRs than in WKY rats A,B. It wThe expression level of NF-\u03baB in the aorta of SHRs was significantly higher than that in WKY rats C. It wasThe expression levels of C/EBP\u03b2 and C/EBP\u03b4 in the aorta of SHRs were significantly higher than that in WKY rats D,E. It wThe expression levels of IL-6 in the aorta of SHRs were significantly higher than that in WKY rats F. It wasThe ratio of peNOS/eNOS expression in the aorta of SHRs was significantly lower than that in WKY rats . It was + ratio in the aorta of SHRs was significantly higher than that in WKY rats (The nitrate/nitrite level in the aorta of SHRs was significantly higher than that in WKY rats C. It wasWKY rats D. It wasThe systolic blood pressure (BP) of SHRs was significantly higher than that of WKY rats E. It wasEndothelial cells, which make a lining of blood vessels, have prothrombotic, proinflammatory, and proconstrictive actions . EndotheMany studies have shown that gut epithelial cell barriers are associated with endothelial cell dysfunction, which is a major pathophysiological factor underlying hypertension . RecentlWe evaluated intestinal barrier impairment by measuring the number of goblet cells, thickness of tunica muscularis, and length of villi. It was reported that these changes of intestinal impairment were shown in SHR . Our stuSHR is the most widely used animal model for essential hypertension, which the incidence is up to 95% in human hypertension . In addiThus, we thought SHR was the proper animal model to evaluate the effect of ECE and DK on endothelial cell dysfunction in hypertension. In addition, the results of our study showed that the expression of Th17 cell/Treg and IL-17A in the intestine of SHR was different from WKY. It suggested that SHR might be the proper model to evaluate the attenuation effect of ECE or DK in the intestine by modulating Th17 cell/Treg balance. In our study, ECE or DK showed to be preserved the intestinal barrier in SHR. We also evaluated expression of ZO-1 and occludin in the intestine of SHR. The expression level of ZO-1 and occludin in the intestine of SHRs was significantly decreased compared with that in WKY rats, and it was increased following the administration of ECE or DK. It is known that increased gut permeability is accompanied by decreasing gut junctional proteins in an angiotensin II-induced hypertension animal model . PrehypeThe administration of ECE or DK significantly decreased the expression level of a marker of Th17 cells and increased the expression of a marker of Treg cells in the intestine of SHRs. The expression level of IL-17A in the intestine of SHRs was also decreased following the administration of ECE or DK. Meanwhile, the expression level of IL-10 in the intestine of SHRs was significantly increased by ECE or DK treatment. It seems that ECE or DK restored the Treg/Th17 balance in the intestine of SHR, decreased the expression of IL-17A, and increased the expression of IL-10.It is known that SGK1 involves changes of Th17/Treg balance . SGK1 inIn our study, the number of Th17 cells was increased in the aorta of SHRs, but was significantly decreased by either ECE or DK. Moreover, the number of Treg cells was decreased in the aorta of SHRs, but was significantly increased by either ECE or DK. The expression level of IL-17A was increased in the aorta of SHRs, whereas the expression of IL-10 was decreased. These two changes were reversed following the administration of ECE or DK. We also evaluated the IL-17A/NF-\u03baB/IL-6 pathway, which induced endothelial cell dysfunction. IL-6 is considered a biomarker in the development of atherosclerosis and progression of inflammation in atherosclerotic vessels ,67. IL-6The binding of IL-17A to IL-17RA requires ACT and TRAF6 to activate NF-\u03baB . NF-\u03baB aThe peNOS/eNOS ratio in the aorta of SHRs was decreased, but it was increased by ECE or DK treatments. The nitrate/nitrite ratio in the aorta of SHRs was increased, but it decreased following ECE or DK. NADPH oxidase activity was increased in the aorta of SHRs, which was decreased by ECE or DK treatment. It appeared that ECE or DK attenuated endothelial cell dysfunction in SHR. The systolic BP, diastolic BP, and mean BP of SHR were decreased by administration of either ECE or DK. It seems that the attenuating effect of ECE or DK on endothelial cell dysfunction lead to decrease BP. Phlorotannins from ECE contains DK, 2,7-phloroglucinol-6,6-bieckol (PHB), pyrogallol-phloroglucinol-6,6-bieckol (PPB), and phlorofucofuroeckol-A (PFFA) ,73,74. IECE contained 2% DK ; thus, 1Gut health, especially the balance of Treg/Th17 cells, is important for avoiding endothelial cell dysfunction, which is a major pathophysiological factor underlying various cardiovascular diseases including hypertension and atherosclerosis. Our study suggested that ECE or DK could modulate the Treg/Th17 balance in both intestine and aorta, and decrease endothelial cell dysfunction by decreasing the activity of the IL-17A/NF-\u03baB/IL-6 pathway. The results suggested that DK could be potentially used as a therapeutic agent for endothelial dysfunction by modulating gut health.", "texts": ["Ecklonia cava and E. cava extract (ECE) decreases blood pressure by reducing inflammation; however, it has not been elucidated whether DK or ECE modulates the Treg/Th17 balance, changes the gut epithelial barrier, or decreases endothelial cell dysfunction. We evaluated the effects of ECE and DK on gut barrier and the Treg/Th17 balance in the intestine and aorta, with regard to endothelial dysfunction, using the spontaneously hypertensive rat (SHR) model. The level of Th17 cells increased and that of Treg cells decreased in the intestine of SHRs compared to normotensive Wistar Kyoto (WKY) rat. These changes were attenuated by ECE or DK treatment. Additionally, the serum IL-17A level increased in SHRs more than WKY; this was decreased by ECE or DK treatment. The level of Treg cells decreased and that of Th17 cells increased in the aorta of SHRs. These changes were attenuated by ECE or DK treatment. The NF-\u03baB and IL-6 levels were increased in SHRs, but these changes were reversed by ECE or DK treatment. Endothelial cell dysfunction, which was evaluated using peNOS/eNOS, nitrate/nitrite ratio, and NADPH oxidase activity, increased in the aorta of SHRs, but was decreased by ECE or DK treatment. The Treg/Th17 balance in the intestine and aorta of SHRs was attenuated and endothelial cell dysfunction was attenuated through the Th17/NF-\u03baB/IL-6 pathway by ECE or DK. Disruptions of the Treg/Th17 cell balance and gut barrier function are associated with endothelial dysfunction. Dieckol (DK) obtained from  As a physical barrier, the gut epithelial barrier, composed of epithelium, mucus lining, and junctional proteins, is involved in modulating the absorption of nutrients and limiting the passage of pathogens or unwanted molecules into the systemic circulation . StructuStudies have shown that gut permeability, which was evaluated by measuring fluorescein isothiocyanate (FITC)-dextran in the plasma, was increased in adult spontaneously hypertensive rat (SHR) compared with that in age-matched normotensive Wistar Kyoto (WKY) rat ,6. In ad+ T helper subset that produces interleukin (IL)-17A, which aggravates tissue inflammation [T helper 17 (Th17) cells are a unique CD4ammation ,9. Underammation , are invammation ,12. Howeammation .IL-17A binds to IL-17 receptor A (IL-17RA) and activates various signal pathways related to inflammation, such as nuclear factor-\u03baB (NF-\u03baB) . For NF-Modulation of Th17/Tregs balance by increasing Treg cells restored tight junction of intestinal epithelial cell barrier in the inflammatory bowel disease . It is kSerum/glucocorticoid-regulated kinase 1 (SGK1) is essential for regulating Th17/Treg balance . IL-23 sEcklonia cava, is known to exert antihypertensive effects by inhibiting angiotensin 1-converting enzyme [E. cava extract (ECE) attenuated endothelial cell dysfunction by reducing the inflammation of perivascular fat tissue [Meanwhile, dieckol (DK), a phlorotannin present in g enzyme . Previout tissue . AlthougE. cava was obtained from Aqua Green Technology Co., Ltd. . For extraction, E. cava was washed and air-dried at room temperature for 48 h, after which the blades were ground and 50% ethanol was added, followed by incubation at 85 \u00b0C for 12 h. ECE was filtered, concentrated, sterilized by heating to \u226585 \u00b0C for 40\u201360 min, and then spray-dried. DK, one of the representative phlorotannins present in ECE, was isolated using centrifugal partition chromatography (CPC). CPC was performed using a two-phase solvent system comprising water/ethyl acetate/methyl alcohol/n-hexane . The organic stationary phase was filled in the CPC column, followed by pumping of the mobile phase into the column in descending mode at the same flow rate used for separation (2 mL/min). We finally confirmed that the purity of the DK used in the study was 93.58% [s 93.58% .n = 25, n = 5 for each of the 5 groups) and WKY rats  were obtained from Orient Bio  and housed at a constant temperature of approximately 23 \u00b0C, relative humidity of 50%, and a dark/light cycle of 12/12 h. The rats were acclimated to the conditions for 1 week. The rats were then randomly categorized into six groups. For 4 weeks, the rats were orally administered drinking water , and SHRs were orally administered ECE  or DK . At the end of the four-week study period, blood pressure of all rats was measured by using a noninvasive tail-cuff CODA system  [Male SHRs  ,35. Afteg for 15 min at 4 \u00b0C. The aqueous phase was collected, placed in cleaned tubes, mixed with 0.5 mL of isopropanol, and centrifuged at the same conditions. The supernatant was discarded, leaving only the RNA pellet that was then washed with 70% ethanol and dissolved in 50 \u00b5L of diethyl pyrocarbonate-treated water. The isolated RNA was synthesized with cDNA using a Prime Script 1st strand cDNA Synthesis Kit according to the manufacturer\u2019s instructions .The rat intestine and aorta were homogenized in ice using a disposable pestle in 1 mL of RNisol , and homogenates were added to 0.2 mL of chloroform, mixed, and centrifuged at 12,000\u00d7 TM software [Quantitative real-time polymerase chain reaction (qRT-PCR) was performed using cDNA synthesis by the CFX384 TouchTM Real-Time PCR detection system. Two hundred nanograms of cDNA, 5 \u03bcL of SYBR premix , 0.4 \u03bcM forward and reverse primers  [Staining with PAS was used to determine the intestinal mucosa with goblet cells in absorptive columnar epithelium. Deparaffined intestine tissue sections were stained with using the PAS staining kit . The intestinal tissue slides were oxidized in 1% periodic acid solution  for 5 min, rinsed in distilled water, and placed in Schiff reagent  for 20 min at room temperature. Nuclei were stained with Harris\u2019 hematoxylin , and the slides were cover-slipped using a mounting medium and observed under an optical microscope . The number of PAS-positive goblet cells per \u03bcmMD, USA) . MorphomH&E staining was used for determining the intestinal pathologic changes including villi length and tunica muscularis thickness. The intestinal tissue slides were incubated with hematoxylin  for 1 min, rinsed in distilled water for 10 min, and placed in eosin Y solution  for 1 min at room temperature. Nuclei were detected with blue color and cytoplasm was detected with light pink, and the completed slides observed under an optical microscope . The villi length and tunica muscularis thickness were measured by ImageJ  . Histolog for 10 min and the supernatant was transferred to a new tube. The transparent serum specimens obtained were stored in a freezer at \u221280 \u00b0C.To measure the serum IL-17A and IL-10 levels, 1 mL of blood was centrifuged and incubated in serum separator tubes  for 30 min. Samples were then centrifuged at 2000\u00d7 The 96-well microplates were coated with anti-IL-17A and anti-IL-10 antibodies diluted in 100 nM carbonate and bicarbonate mixed buffer, adjusted to pH 9.6, and incubated overnight at 4 \u00b0C. The microplates were then washed with PBS containing 0.1% Triton X-100 (TPBS). The remaining protein-binding sites were then blocked using 5% skim milk for 6 h at room temperature . After w+ ratio  in the aorta of each group were determined using the appropriate kit, in accordance with the manufacturer\u2019s instructions. Nitrate/nitrite levels  and NADP/NADPHNonparametric tests were performed in this study. The Kruskal\u2013Wallis test was used to determine the significance of differences among the WKY/water, SHR/water, and SHR/ECE150 groups. If significant difference was confirmed by Kruskal\u2013Wallis, multiple comparison was performed with the Mann\u2013Whitney U test. Results were presented as mean \u00b1 SD, and statistical significance was accepted as follows: *, versus WKY/water; $, versus SHR/water; and #, versus SHR/ECE150. Statistical analysis was performed using SPSS version 22 .The mRNA expression level of a Th17 cell marker (ROR\u03b3t) in the intestine of SHRs was higher than that in WKY rats, but it was decreased following treatment with either ECE or DK A. The deThe expression level of IL-17A in the intestine of SHRs was significantly higher than that in WKY rats C,D. It wThe expression level of zonula occludens-1 (ZO-1), a tight junction protein of the gut barrier, was evaluated to confirm gut barrier integrity A,B. The The number of goblet cells in the PAS-stained intestine was decreased in SHRs compared with that in WKY rats C,D. It wThe thickness of tunica muscularis was increased in SHRs compared with that in WKY rats E,F. It wThe increasing effect was most prominent in the 100 and 150 mg/kg ECE treatment. The mRNA expression level of SGK1 in the intestine of SHRs was significantly increased, which was in turn significantly decreased following the administration of 100 and 150 mg/kg ECE and DK H. The deThe serum level of IL-17A in SHRs was significantly higher than that in WKY rats. This level was decreased following the administration of either ECE or DK). The decreasing effect was most prominent in the 150 mg/kg ECE treatment . The serum level of IL-10 in SHRs was significantly lower than that in WKY rats, but it was significantly increased following the administration of either ECE or DK. The increasing effect was most prominent in the 150 mg/kg ECE treatment .The mRNA expression of ROR\u03b3t (a marker of Th17) in the aorta of SHRs was increased compared with that in WKY rats A. HoweveThe expression level of IL-17A in the aorta of SHRs was significantly increased compared with that in WKY rats C,D. It wThe expression levels of ACT and TRAF6, which are essential factors for IL-17A to initiate the upregulation of NF-\u03baB, was significantly higher in the aorta of SHRs than in WKY rats A,B. It wThe expression level of NF-\u03baB in the aorta of SHRs was significantly higher than that in WKY rats C. It wasThe expression levels of C/EBP\u03b2 and C/EBP\u03b4 in the aorta of SHRs were significantly higher than that in WKY rats D,E. It wThe expression levels of IL-6 in the aorta of SHRs were significantly higher than that in WKY rats F. It wasThe ratio of peNOS/eNOS expression in the aorta of SHRs was significantly lower than that in WKY rats . It was + ratio in the aorta of SHRs was significantly higher than that in WKY rats (The nitrate/nitrite level in the aorta of SHRs was significantly higher than that in WKY rats C. It wasWKY rats D. It wasThe systolic blood pressure (BP) of SHRs was significantly higher than that of WKY rats E. It wasEndothelial cells, which make a lining of blood vessels, have prothrombotic, proinflammatory, and proconstrictive actions . EndotheMany studies have shown that gut epithelial cell barriers are associated with endothelial cell dysfunction, which is a major pathophysiological factor underlying hypertension . RecentlWe evaluated intestinal barrier impairment by measuring the number of goblet cells, thickness of tunica muscularis, and length of villi. It was reported that these changes of intestinal impairment were shown in SHR . Our stuSHR is the most widely used animal model for essential hypertension, which the incidence is up to 95% in human hypertension . In addiThus, we thought SHR was the proper animal model to evaluate the effect of ECE and DK on endothelial cell dysfunction in hypertension. In addition, the results of our study showed that the expression of Th17 cell/Treg and IL-17A in the intestine of SHR was different from WKY. It suggested that SHR might be the proper model to evaluate the attenuation effect of ECE or DK in the intestine by modulating Th17 cell/Treg balance. In our study, ECE or DK showed to be preserved the intestinal barrier in SHR. We also evaluated expression of ZO-1 and occludin in the intestine of SHR. The expression level of ZO-1 and occludin in the intestine of SHRs was significantly decreased compared with that in WKY rats, and it was increased following the administration of ECE or DK. It is known that increased gut permeability is accompanied by decreasing gut junctional proteins in an angiotensin II-induced hypertension animal model . PrehypeThe administration of ECE or DK significantly decreased the expression level of a marker of Th17 cells and increased the expression of a marker of Treg cells in the intestine of SHRs. The expression level of IL-17A in the intestine of SHRs was also decreased following the administration of ECE or DK. Meanwhile, the expression level of IL-10 in the intestine of SHRs was significantly increased by ECE or DK treatment. It seems that ECE or DK restored the Treg/Th17 balance in the intestine of SHR, decreased the expression of IL-17A, and increased the expression of IL-10.It is known that SGK1 involves changes of Th17/Treg balance . SGK1 inIn our study, the number of Th17 cells was increased in the aorta of SHRs, but was significantly decreased by either ECE or DK. Moreover, the number of Treg cells was decreased in the aorta of SHRs, but was significantly increased by either ECE or DK. The expression level of IL-17A was increased in the aorta of SHRs, whereas the expression of IL-10 was decreased. These two changes were reversed following the administration of ECE or DK. We also evaluated the IL-17A/NF-\u03baB/IL-6 pathway, which induced endothelial cell dysfunction. IL-6 is considered a biomarker in the development of atherosclerosis and progression of inflammation in atherosclerotic vessels ,67. IL-6The binding of IL-17A to IL-17RA requires ACT and TRAF6 to activate NF-\u03baB . NF-\u03baB aThe peNOS/eNOS ratio in the aorta of SHRs was decreased, but it was increased by ECE or DK treatments. The nitrate/nitrite ratio in the aorta of SHRs was increased, but it decreased following ECE or DK. NADPH oxidase activity was increased in the aorta of SHRs, which was decreased by ECE or DK treatment. It appeared that ECE or DK attenuated endothelial cell dysfunction in SHR. The systolic BP, diastolic BP, and mean BP of SHR were decreased by administration of either ECE or DK. It seems that the attenuating effect of ECE or DK on endothelial cell dysfunction lead to decrease BP. Phlorotannins from ECE contains DK, 2,7-phloroglucinol-6,6-bieckol (PHB), pyrogallol-phloroglucinol-6,6-bieckol (PPB), and phlorofucofuroeckol-A (PFFA) ,73,74. IECE contained 2% DK ; thus, 1Gut health, especially the balance of Treg/Th17 cells, is important for avoiding endothelial cell dysfunction, which is a major pathophysiological factor underlying various cardiovascular diseases including hypertension and atherosclerosis. Our study suggested that ECE or DK could modulate the Treg/Th17 balance in both intestine and aorta, and decrease endothelial cell dysfunction by decreasing the activity of the IL-17A/NF-\u03baB/IL-6 pathway. The results suggested that DK could be potentially used as a therapeutic agent for endothelial dysfunction by modulating gut health."]}
{"representative": "The combination of breast conserving surgery (BCS) with plastic surgery techniques has provided a useful surgical tool matching the radicality of the oncological excision with the preservation of breast cosmesis. Even though BCS represents a good option for surgical treatment of tumors located in these quadrants, wide excisions often necessitate breast reshaping in order to avoid nipple areola complex (NAC) displacement and skin retraction. We present a new surgical technique to repair upper-outer quadrants\u2019 defects following breast cancer excision using dermo-glandular flaps and an axillary adipo-fascial flap.During the period from January 2014 to December 2015, 168 patients with an upper-outer quadrant\u2019s breast cancer have been treated in our Department. 83 women have been treated with the described oncoplastic technique and immediate contra-lateral symmetrisation and 85 women underwent standard BCS. We present surgical, oncological and cosmetic outcomes comparing our results with standard BCS.At a mean follow-up of 27\u2009months loco-regional recurrences in the two groups were comparable. Short-term complication rates were comparable between the two groups. Re-intervention rates for positive margins were significantly higher in the standard BCS group. The overall satisfaction with cosmetic outcome both assessed by the patient and the surgeon was significantly higher in the oncoplastic group.The proposed oncoplastic technique represents a safe and effective solution for reshaping that follows upper-outer breast cancer wide excision, achieving comparable complication rates, lower re-intervention rates for positive margins and better cosmetic results when compared with standard BCS. The upper-outer quadrant of the breast is the most common location for breast cancer. Conventional Breast Conserving Surgery (BCS) is nowadays the standard surgical approach for the treatment of breast cancer located in the upper outer quadrants.Although BCS followed by radiotherapy presents comparable survival rates with patients treated with mastectomy, it may hesitate in breast deformity in 20\u201330% of cases , 2. FurtThe possible distortion of breast shape and the following poor cosmetic result lead surgeons to develop different surgical techniques in order to overcome the aestethic discomfort for the patient . The so-We present a new surgical technique to repair upper-outer quadrants\u2019 defects following breast cancer excision using dermo-glandular flaps and an axillary adipo-fascial flap. We present surgical and oncological outcomes comparing our results with standard BCS for the treatment of breast cancer located in the upper-outer quadrants.We retrospectively collected from our database all the women who underwent upper-outer quandrantectomies in our Department in the period from January 2014 to December 2015.Women with a diagnosis of both invasive or in situ breast cancer, affected by both unifocal or multifocal lesions located at the level of the upper-outer quadrant have been enrolled in the study.We divided our cohort of patients in two groups according with the surgical technique used to excise the breast cancer. The first group included 83 women who underwent our innovative oncoplastic technique and immediate contra-lateral breast symmeytrisation. The second group included 85 women who underwent a standard upper-outer BCS.Women who previously underwent breast or axillary surgery or chest radiotherapy have been excluded. Patients with clinical pre-operative or histological intra-operative evidence of axillary lymph node involvement have been excluded as well, such as patients presenting skin involvement of the cancer, local recurrence, distant metastases or genetic mutations.This study was approved by our institutional review board  and appropriate informed consent was obtained from all patients for the surgical procedures performed in the present study and for personal images use and publication.Ultrasound examination, mammography, MRI and subsequent vacuum-assisted breast biopsy have been performed for all patients. All patients underwent a multidisciplinary approach, involving medical and surgical oncologists, plastic surgeons, breast radiologists, and radiation oncologists. In order to perform breast conserving surgery, we localized the lesions the day before surgery using Tc99m-MAA ; the sentinel lymph node was localized preoperatively by injecting Tc99m-nanocoll.Positive margins were defined as presence of cancer cells at less than 1\u2009mm from the specimen\u2019s margin.Post-operative radiotherapy (50\u2009Gy on the breast) was administered in each case.We assessed short-term post-operative complications (occurring less than 30\u2009days after surgery), re-operations for positive margins of resection, local recurrences and cosmetic outcome (both patient-reported and surgeon-reported).In the study group patients were marked the day before surgery with a vertical or inverted-T Wise pattern approach according to the balance between the expected tumor excision dimension and breast volume.Antibiotic prophylactic therapy was administered to all patients according to hospital protocols.The patient was placed in supine position with the arms abducted to 90 degrees and fixed on arm boards.A two team approach was always planned in order to reduce operation room time and decrease the surgical stress for patients.With a blade number 10 the incision was performed and all the skin within the preoperative markings was removed. Subsequently the skin over the tumor was undermined leaving a flap thickness of 3\u20134\u2009mm. A wide tumor resection through the glandular tissue reaching the pectoralis major muscle fascia was performed.Intra-operative frozen sections or radiographic examinations  of the specimen were performed in order to proceed to immediate re-excision if necessary.Surgical clips were placed in the tumor bed following the tumor resection.The sentinel lymph node biopsy was performed through the same skin incision.Subsequent total skin undermining was performed in the medial and inferior quadrants of the breast to completely detach the gland from the skin.An infero-lateral glandular flap was advanced upward, rotated and fixed with a 2/0 absorbable monofilament suture to an adipo-fascial flap mobilized from the axilla.Then the residual glandular tissue of the upper portion of the breast could be approximated to the described flap and the nipple-areola complex was fixed in the desired position Figs.\u00a0 and 2.FiWhen necessary, suction drains were positioned and then the suture was completed.Contra-lateral symmetrization mammoplasty was always performed simultaneously.Antibiotic therapy had been administered to all patients until drain\u2019s removal.In the control group patients underwent a standard upper-outer quadrantectomy. Sentinel Lymph node biopsy was performed through the same surgical incision.p value of 0.05 or less was considered statistically significant. All the analyses were performed using SPSS 22 software package .Variables were analysed using the chi-square test. A During the period from January 2014 to December 2015, 168 patients with an upper-outer quadrant\u2019s breast cancer have been treated in our Department.Eighty-three women have been treated with the described oncoplastic technique and immediate contra-lateral symmetrisation (study group) and 85 women underwent standard BCS (control group).Patients\u2019 Median age was 57.5\u2009years (range 39\u201376) for the study group and 58.3\u2009years (range 38\u201379) for the control group, median Body Mass Index (BMI) was 24.5\u2009kg/cm2 (range 20.2\u201332.6) for the study group and 25.1\u2009kg/cm2 (range 20.5\u201333.1) for the control group. The two groups were comparable for baseline characteristics and comorbidities. Patients\u2019 comorbidities are presented in Table\u00a0p\u2009=\u20090.03). All patients with positive surgical margins have been re-operated in both groups.Surgical margins of resection were positive in 2 cases (2.4%) in the study group and in 9 cases (10.6%) in the control group (Mean time of follow-up was 27\u2009months (range 16\u201339). During this period one patient (1.2%) has been re-operated for a local recurrence both in the study group and in the control group. Both patients presenting with a local recurrence were affected by Intermediate Grade (G2) Ductal Carcinoma In Situ (DCIS), completely excised at primary surgery with more than 5\u2009mm free margin, and recurred as pT1N0 Invasive Ductal Carcinoma (IDC) at a follow-up of 25\u2009months (in the study group) and 20\u2009months (in the control group). Both patients underwent skin sparing mastectomy and breast reconstruction with tissue expander positioning.p\u2009=\u20090.79); hormonal therapy was provided to 57 patients (68.7%) in the study group and 60 patients (70.6%) in the control group (p\u2009=\u20090.68); Trastuzumab was provided to 13 patients (15.7%) in the study group and 14 patients (16.5%) in the control group. Oncological characteristics  of both groups were comparable and are presented in Table\u00a0All patients included in the study received post-operative radiotherapy. Adjuvant chemotherapy was administered to 23 patients (27.7%) in the study group and 26 patients (30.6%) in the control group (p\u2009=\u20090.50). In the study group we experienced 4 wound dehiscences, 4 fat or glandular necrosis, 2 seroma formation, 2 hematoma, 4 marginal skin necrosis, 2 partial NAC necrosis.We experienced a total of 18 (21.7%) short-term post-operative complications in the study group and 15 (17.6%) in the control group (p\u2009=\u20090.67), fat or glandular necrosis (p\u2009=\u20090.67), seroma formation (p\u2009=\u20090.67), hematoma (p\u2009=\u20090.67), marginal skin necrosis (p\u2009=\u20090.38), partial NAC necrosis (p\u2009=\u20090.56).In the control group we experienced 3 wound dehiscences, 3 fat or glandular necrosis, 3 seroma formation, 3 hematoma, 2 marginal skin necrosis, 1 partial NAC necrosis. Complication rates were comparable: wound dehiscence ; the overall satisfaction with cosmetic outcome assessed by the surgeon was considered excellent in 48 cases (57.8%) in the study group and in 35 cases (41.2%) in the control group (p\u2009<\u20090.0001)  in the study group, while in 32 cases (36.6%) in the control group (Breast Conserving Surgery (BCS) followed by radiotherapy has become the standard surgical approach for early stage breast cancer \u201315.When adequate surgical margins are obtained local recurrence rates have been documented to range from 3.5 to 6.5% at 10-year follow-up , 17. TheUpper-outer quadrantectomies can be easily performed with standard BCS but breast deformity and NAC displacement may follow this procedure. Different oncoplastic approaches have been proposed during the years trying to overcome these complications. Small-sized breasts with early breast cancer can be effectively treated by Benelli mastoplasty: glandular rotation flaps combine good cosmetic results with satisfactory resections . When wiWe aim to propose a reliable technique both respecting oncological radicality and preserving a pleasant breast contour. The large skin undermining and the breast reshaping performed using our technique do not determine NAC dislocations and irregular breast shapes.Fitoussi and colleagues stated that the huge undermining could lead to increased rates of seroma, fat necrosis, bleeding and the NAC transposition may cause partial or total necrosis . Other aFurthermore from an oncological point of view, we confirmed other data reported in literature evidencing that the oncoplastic approach reduces the number of re-operations for positive or close margins , 28.We did not experience any delay for adjuvant therapies, either radio or chemotherapy, caused by a longer time of wound healing.Some author suggest to postpone contra-lateral breast symmetrization after radiotherapy because of the risk of volume modification in the radiotreated breast . We agreOur study presents the limitation of being retrospective and a longer follow-up could further confirm the oncological safety of the proposed surgical approach .The proposed oncoplastic technique represents a safe and effective solution for reshaping that follows upper-outer breast cancer wide excision, achieving comparable complication rates, lower re-intervention rates for positive margins and better cosmetic results when compared with standard BCS.", "texts": ["The combination of breast conserving surgery (BCS) with plastic surgery techniques has provided a useful surgical tool matching the radicality of the oncological excision with the preservation of breast cosmesis. Even though BCS represents a good option for surgical treatment of tumors located in these quadrants, wide excisions often necessitate breast reshaping in order to avoid nipple areola complex (NAC) displacement and skin retraction. We present a new surgical technique to repair upper-outer quadrants\u2019 defects following breast cancer excision using dermo-glandular flaps and an axillary adipo-fascial flap.During the period from January 2014 to December 2015, 168 patients with an upper-outer quadrant\u2019s breast cancer have been treated in our Department. 83 women have been treated with the described oncoplastic technique and immediate contra-lateral symmetrisation and 85 women underwent standard BCS. We present surgical, oncological and cosmetic outcomes comparing our results with standard BCS.At a mean follow-up of 27\u2009months loco-regional recurrences in the two groups were comparable. Short-term complication rates were comparable between the two groups. Re-intervention rates for positive margins were significantly higher in the standard BCS group. The overall satisfaction with cosmetic outcome both assessed by the patient and the surgeon was significantly higher in the oncoplastic group.The proposed oncoplastic technique represents a safe and effective solution for reshaping that follows upper-outer breast cancer wide excision, achieving comparable complication rates, lower re-intervention rates for positive margins and better cosmetic results when compared with standard BCS. The upper-outer quadrant of the breast is the most common location for breast cancer. Conventional Breast Conserving Surgery (BCS) is nowadays the standard surgical approach for the treatment of breast cancer located in the upper outer quadrants.Although BCS followed by radiotherapy presents comparable survival rates with patients treated with mastectomy, it may hesitate in breast deformity in 20\u201330% of cases , 2. FurtThe possible distortion of breast shape and the following poor cosmetic result lead surgeons to develop different surgical techniques in order to overcome the aestethic discomfort for the patient . The so-We present a new surgical technique to repair upper-outer quadrants\u2019 defects following breast cancer excision using dermo-glandular flaps and an axillary adipo-fascial flap. We present surgical and oncological outcomes comparing our results with standard BCS for the treatment of breast cancer located in the upper-outer quadrants.We retrospectively collected from our database all the women who underwent upper-outer quandrantectomies in our Department in the period from January 2014 to December 2015.Women with a diagnosis of both invasive or in situ breast cancer, affected by both unifocal or multifocal lesions located at the level of the upper-outer quadrant have been enrolled in the study.We divided our cohort of patients in two groups according with the surgical technique used to excise the breast cancer. The first group included 83 women who underwent our innovative oncoplastic technique and immediate contra-lateral breast symmeytrisation. The second group included 85 women who underwent a standard upper-outer BCS.Women who previously underwent breast or axillary surgery or chest radiotherapy have been excluded. Patients with clinical pre-operative or histological intra-operative evidence of axillary lymph node involvement have been excluded as well, such as patients presenting skin involvement of the cancer, local recurrence, distant metastases or genetic mutations.This study was approved by our institutional review board  and appropriate informed consent was obtained from all patients for the surgical procedures performed in the present study and for personal images use and publication.Ultrasound examination, mammography, MRI and subsequent vacuum-assisted breast biopsy have been performed for all patients. All patients underwent a multidisciplinary approach, involving medical and surgical oncologists, plastic surgeons, breast radiologists, and radiation oncologists. In order to perform breast conserving surgery, we localized the lesions the day before surgery using Tc99m-MAA ; the sentinel lymph node was localized preoperatively by injecting Tc99m-nanocoll.Positive margins were defined as presence of cancer cells at less than 1\u2009mm from the specimen\u2019s margin.Post-operative radiotherapy (50\u2009Gy on the breast) was administered in each case.We assessed short-term post-operative complications (occurring less than 30\u2009days after surgery), re-operations for positive margins of resection, local recurrences and cosmetic outcome (both patient-reported and surgeon-reported).In the study group patients were marked the day before surgery with a vertical or inverted-T Wise pattern approach according to the balance between the expected tumor excision dimension and breast volume.Antibiotic prophylactic therapy was administered to all patients according to hospital protocols.The patient was placed in supine position with the arms abducted to 90 degrees and fixed on arm boards.A two team approach was always planned in order to reduce operation room time and decrease the surgical stress for patients.With a blade number 10 the incision was performed and all the skin within the preoperative markings was removed. Subsequently the skin over the tumor was undermined leaving a flap thickness of 3\u20134\u2009mm. A wide tumor resection through the glandular tissue reaching the pectoralis major muscle fascia was performed.Intra-operative frozen sections or radiographic examinations  of the specimen were performed in order to proceed to immediate re-excision if necessary.Surgical clips were placed in the tumor bed following the tumor resection.The sentinel lymph node biopsy was performed through the same skin incision.Subsequent total skin undermining was performed in the medial and inferior quadrants of the breast to completely detach the gland from the skin.An infero-lateral glandular flap was advanced upward, rotated and fixed with a 2/0 absorbable monofilament suture to an adipo-fascial flap mobilized from the axilla.Then the residual glandular tissue of the upper portion of the breast could be approximated to the described flap and the nipple-areola complex was fixed in the desired position Figs.\u00a0 and 2.FiWhen necessary, suction drains were positioned and then the suture was completed.Contra-lateral symmetrization mammoplasty was always performed simultaneously.Antibiotic therapy had been administered to all patients until drain\u2019s removal.In the control group patients underwent a standard upper-outer quadrantectomy. Sentinel Lymph node biopsy was performed through the same surgical incision.p value of 0.05 or less was considered statistically significant. All the analyses were performed using SPSS 22 software package .Variables were analysed using the chi-square test. A During the period from January 2014 to December 2015, 168 patients with an upper-outer quadrant\u2019s breast cancer have been treated in our Department.Eighty-three women have been treated with the described oncoplastic technique and immediate contra-lateral symmetrisation (study group) and 85 women underwent standard BCS (control group).Patients\u2019 Median age was 57.5\u2009years (range 39\u201376) for the study group and 58.3\u2009years (range 38\u201379) for the control group, median Body Mass Index (BMI) was 24.5\u2009kg/cm2 (range 20.2\u201332.6) for the study group and 25.1\u2009kg/cm2 (range 20.5\u201333.1) for the control group. The two groups were comparable for baseline characteristics and comorbidities. Patients\u2019 comorbidities are presented in Table\u00a0p\u2009=\u20090.03). All patients with positive surgical margins have been re-operated in both groups.Surgical margins of resection were positive in 2 cases (2.4%) in the study group and in 9 cases (10.6%) in the control group (Mean time of follow-up was 27\u2009months (range 16\u201339). During this period one patient (1.2%) has been re-operated for a local recurrence both in the study group and in the control group. Both patients presenting with a local recurrence were affected by Intermediate Grade (G2) Ductal Carcinoma In Situ (DCIS), completely excised at primary surgery with more than 5\u2009mm free margin, and recurred as pT1N0 Invasive Ductal Carcinoma (IDC) at a follow-up of 25\u2009months (in the study group) and 20\u2009months (in the control group). Both patients underwent skin sparing mastectomy and breast reconstruction with tissue expander positioning.p\u2009=\u20090.79); hormonal therapy was provided to 57 patients (68.7%) in the study group and 60 patients (70.6%) in the control group (p\u2009=\u20090.68); Trastuzumab was provided to 13 patients (15.7%) in the study group and 14 patients (16.5%) in the control group. Oncological characteristics  of both groups were comparable and are presented in Table\u00a0All patients included in the study received post-operative radiotherapy. Adjuvant chemotherapy was administered to 23 patients (27.7%) in the study group and 26 patients (30.6%) in the control group (p\u2009=\u20090.50). In the study group we experienced 4 wound dehiscences, 4 fat or glandular necrosis, 2 seroma formation, 2 hematoma, 4 marginal skin necrosis, 2 partial NAC necrosis.We experienced a total of 18 (21.7%) short-term post-operative complications in the study group and 15 (17.6%) in the control group (p\u2009=\u20090.67), fat or glandular necrosis (p\u2009=\u20090.67), seroma formation (p\u2009=\u20090.67), hematoma (p\u2009=\u20090.67), marginal skin necrosis (p\u2009=\u20090.38), partial NAC necrosis (p\u2009=\u20090.56).In the control group we experienced 3 wound dehiscences, 3 fat or glandular necrosis, 3 seroma formation, 3 hematoma, 2 marginal skin necrosis, 1 partial NAC necrosis. Complication rates were comparable: wound dehiscence ; the overall satisfaction with cosmetic outcome assessed by the surgeon was considered excellent in 48 cases (57.8%) in the study group and in 35 cases (41.2%) in the control group (p\u2009<\u20090.0001)  in the study group, while in 32 cases (36.6%) in the control group (Breast Conserving Surgery (BCS) followed by radiotherapy has become the standard surgical approach for early stage breast cancer \u201315.When adequate surgical margins are obtained local recurrence rates have been documented to range from 3.5 to 6.5% at 10-year follow-up , 17. TheUpper-outer quadrantectomies can be easily performed with standard BCS but breast deformity and NAC displacement may follow this procedure. Different oncoplastic approaches have been proposed during the years trying to overcome these complications. Small-sized breasts with early breast cancer can be effectively treated by Benelli mastoplasty: glandular rotation flaps combine good cosmetic results with satisfactory resections . When wiWe aim to propose a reliable technique both respecting oncological radicality and preserving a pleasant breast contour. The large skin undermining and the breast reshaping performed using our technique do not determine NAC dislocations and irregular breast shapes.Fitoussi and colleagues stated that the huge undermining could lead to increased rates of seroma, fat necrosis, bleeding and the NAC transposition may cause partial or total necrosis . Other aFurthermore from an oncological point of view, we confirmed other data reported in literature evidencing that the oncoplastic approach reduces the number of re-operations for positive or close margins , 28.We did not experience any delay for adjuvant therapies, either radio or chemotherapy, caused by a longer time of wound healing.Some author suggest to postpone contra-lateral breast symmetrization after radiotherapy because of the risk of volume modification in the radiotreated breast . We agreOur study presents the limitation of being retrospective and a longer follow-up could further confirm the oncological safety of the proposed surgical approach .The proposed oncoplastic technique represents a safe and effective solution for reshaping that follows upper-outer breast cancer wide excision, achieving comparable complication rates, lower re-intervention rates for positive margins and better cosmetic results when compared with standard BCS."]}
{"representative": "FIP1L1-PDGFRA gene fusion and bone marrow analysis confirmed a diagnosis of chronic eosinophilic leukemia. The patient was treated with daily imatinib and prednisone and he was symptom-free at a four-week follow-up examination.We report the case of a 40-year-old man with no significant past medical history who had been hospitalized multiple times over the course of one\u00a0year with recurring cough, dyspnea, pruritic rash, and variable degrees of eosinophilia. He was variably diagnosed with asthma and pneumonia. After his last hospitalization with severe symptoms, the patient was referred for pulmonary evaluation where hypereosinophilia (HE) led to a hematologic workup. Fluorescence in situ hybridization revealed the  Asthma and atopy can sometimes present as HE, although an AEC \u22655.0 \u00d7 109 cells/L in these cases would be rare [Peripheral blood eosinophilia, defined as an absolute eosinophil count (AEC) of > 0.5 to 1.0 \u00d7 10entities .\u00a0Hypereo be rare . Rapid d be rare  and coulWe report the case of a man with HE who was hospitalized numerous times before being diagnosed with chronic eosinophilic leukemia and whose symptoms significantly improved upon initiation of therapy.A 40-year-old man had recurrent hospitalizations with cough, pleuritic chest pain, and a relapsing and remitting pruritic papular rash associated with variable levels of eosinophilia. His symptoms were variously attributed to asthma and pneumonia, although he had no history of asthma. He was hospitalized more than six times over one year and was repeatedly treated with steroids and antibiotics. Additionally, he had undergone multiple non-invasive and invasive testing, including several computed tomograms and cardiac imaging.During the last hospitalization, the patient\u2019s symptoms were particularly severe, with cough leading to a syncopal episode and hemoptysis with a rise in cardiac biomarkers. He was transferred to our institution for further pulmonary evaluation. Upon arrival, he presented with pleuritic chest pain, dry cough, anorexia, and diffuse pruritic rash. His vital signs were unremarkable except for tachycardia with a heart rate of 103 beats per minute. Physical examination revealed a chronically ill-appearing man in moderate distress. Scattered erythematous papules that were in various stages of healing were noted on his extremities, some having central ulceration and crusting Figure . ResultsDaily imatinib 400 mg was initiated and prednisone was continued due to concern for cardiac involvement despite normal trans-thoracic echocardiogram. Within one day of imatinib initiation, the patient\u2019s eosinophilia normalized and he was discharged home in stable condition. At the follow-up examination four weeks later, all his symptoms had resolved.\u00a0He reached both hematologic, cytogenetic, and molecular remission within three months of treatment.\u00a0Prednisone was tapered off and his imatinib dose was decreased to 100 mg daily.HE can be primary , secondary to other etiologies, or idiopathic . Once seClonal eosinophilia is most frequently associated with chronic myeloid neoplasms. Chronic eosinophilic leukemia is a rare chronic myeloproliferative disease resulting from clonal proliferation of eosinophil precursors. The 2008 World Health Organization classification of tumors of hematopoietic and lymphoid tissues introduced a new category of myeloid and lymphoid neoplasms characterized by eosinophilia and abnormalities in the PDGFRA, PDGFRB or FGFR1 genes . The FIPThe presence of dysplastic eosinophils may suggest clonal eosinophilia, and elevated serum tryptase and vitamin B12 levels have been observed with myeloid neoplasms, particularly in those with PDGFRA or PDGFRB fusion genes . ClinicaDermatologic manifestations from PDGFRA-associated hypereosinophilic syndrome are common and can include dermatitis and urticaria. Lymphomatoid papulosis with erythematous papulonodular lesions is a recurrent skin eruption, which can become necrotic. It has histopathologic features resembling lymphoma , and aboPatients with documented rearrangements or mutations involving PDGFRA should be treated with imatinib mesylate (100-400 mg by mouth daily). The response to imatinib is rapid (within days), and complete hematologic and molecular remission is almost universal . In our HE can be indicative of chronic eosinophilic leukemia, a rare hematologic malignancy, which can often be mistaken for more common conditions such as asthma, pneumonia, allergies, cardiac disease, and others. While chronic eosinophilic leukemia can be treatable, end-organ failure and severe outcomes will ensue if left untreated. Therefore, physicians should be wary of anchoring bias, where uncommon causes of common presentations are not considered, such as occurred in our patient with HE.", "texts": ["FIP1L1-PDGFRA gene fusion and bone marrow analysis confirmed a diagnosis of chronic eosinophilic leukemia. The patient was treated with daily imatinib and prednisone and he was symptom-free at a four-week follow-up examination.We report the case of a 40-year-old man with no significant past medical history who had been hospitalized multiple times over the course of one\u00a0year with recurring cough, dyspnea, pruritic rash, and variable degrees of eosinophilia. He was variably diagnosed with asthma and pneumonia. After his last hospitalization with severe symptoms, the patient was referred for pulmonary evaluation where hypereosinophilia (HE) led to a hematologic workup. Fluorescence in situ hybridization revealed the  Asthma and atopy can sometimes present as HE, although an AEC \u22655.0 \u00d7 109 cells/L in these cases would be rare [Peripheral blood eosinophilia, defined as an absolute eosinophil count (AEC) of > 0.5 to 1.0 \u00d7 10entities .\u00a0Hypereo be rare . Rapid d be rare  and coulWe report the case of a man with HE who was hospitalized numerous times before being diagnosed with chronic eosinophilic leukemia and whose symptoms significantly improved upon initiation of therapy.A 40-year-old man had recurrent hospitalizations with cough, pleuritic chest pain, and a relapsing and remitting pruritic papular rash associated with variable levels of eosinophilia. His symptoms were variously attributed to asthma and pneumonia, although he had no history of asthma. He was hospitalized more than six times over one year and was repeatedly treated with steroids and antibiotics. Additionally, he had undergone multiple non-invasive and invasive testing, including several computed tomograms and cardiac imaging.During the last hospitalization, the patient\u2019s symptoms were particularly severe, with cough leading to a syncopal episode and hemoptysis with a rise in cardiac biomarkers. He was transferred to our institution for further pulmonary evaluation. Upon arrival, he presented with pleuritic chest pain, dry cough, anorexia, and diffuse pruritic rash. His vital signs were unremarkable except for tachycardia with a heart rate of 103 beats per minute. Physical examination revealed a chronically ill-appearing man in moderate distress. Scattered erythematous papules that were in various stages of healing were noted on his extremities, some having central ulceration and crusting Figure . ResultsDaily imatinib 400 mg was initiated and prednisone was continued due to concern for cardiac involvement despite normal trans-thoracic echocardiogram. Within one day of imatinib initiation, the patient\u2019s eosinophilia normalized and he was discharged home in stable condition. At the follow-up examination four weeks later, all his symptoms had resolved.\u00a0He reached both hematologic, cytogenetic, and molecular remission within three months of treatment.\u00a0Prednisone was tapered off and his imatinib dose was decreased to 100 mg daily.HE can be primary , secondary to other etiologies, or idiopathic . Once seClonal eosinophilia is most frequently associated with chronic myeloid neoplasms. Chronic eosinophilic leukemia is a rare chronic myeloproliferative disease resulting from clonal proliferation of eosinophil precursors. The 2008 World Health Organization classification of tumors of hematopoietic and lymphoid tissues introduced a new category of myeloid and lymphoid neoplasms characterized by eosinophilia and abnormalities in the PDGFRA, PDGFRB or FGFR1 genes . The FIPThe presence of dysplastic eosinophils may suggest clonal eosinophilia, and elevated serum tryptase and vitamin B12 levels have been observed with myeloid neoplasms, particularly in those with PDGFRA or PDGFRB fusion genes . ClinicaDermatologic manifestations from PDGFRA-associated hypereosinophilic syndrome are common and can include dermatitis and urticaria. Lymphomatoid papulosis with erythematous papulonodular lesions is a recurrent skin eruption, which can become necrotic. It has histopathologic features resembling lymphoma , and aboPatients with documented rearrangements or mutations involving PDGFRA should be treated with imatinib mesylate (100-400 mg by mouth daily). The response to imatinib is rapid (within days), and complete hematologic and molecular remission is almost universal . In our HE can be indicative of chronic eosinophilic leukemia, a rare hematologic malignancy, which can often be mistaken for more common conditions such as asthma, pneumonia, allergies, cardiac disease, and others. While chronic eosinophilic leukemia can be treatable, end-organ failure and severe outcomes will ensue if left untreated. Therefore, physicians should be wary of anchoring bias, where uncommon causes of common presentations are not considered, such as occurred in our patient with HE."]}
{"representative": "Heterodontus francisci) are nocturnally active, non-obligate ram ventilating sharks in rocky reef habitats that play an important ecological role in regulating invertebrate communities. We predicted horn sharks would use an area restricted search (ARS) movement strategy to locate dense resource patches while minimizing energetic costs of travel and nighttime activity. As ectotherms, we predicted environmental temperature would play a significant role in driving movement and activity patterns.California horn sharks  as a proxy for energy expenditure. Behavior within a patch was characterized into three activity patterns: resting, episodic burst activity, and moderate, consistent activity.After resting in daytime shelters, individuals travelled to multiple reefs throughout the night, traversing through depths of 2\u2013112\u2009m and temperatures of 10.0\u201323.8\u2009\u00b0C. All sharks exhibited area restricted search patch use and arrived at their first patch approximately 3.4\u2009\u00b1\u20092.2\u2009h (mean\u2009\u00b1\u2009SD) after sunset. Sharks exhibited moderate, consistent activity in 54% of the patches used, episodic burst activity in 33%, and few (13%) were identified as resting at night. ODBA peaked while sharks were swimming through relatively deeper (~\u200930\u2009m), colder channels when traversing from one patch to the next. There was no consistent pattern between ODBA and temperature.We provide one of the largest fine-scale, high-resolution paired data sets for an elasmobranch movement ecology study. Horn sharks exhibited ARS movement patterns for various activity patterns. Individuals likely travel to reefs known to have profitable and predictable patches, potentially tolerating less suitable environmental temperatures. We demonstrate how gathering high-resolution information on the movement decisions of a community resident enhances knowledge of community structure and overall ecosystem function. Mobile animals across all taxa make daily movement decisions to optimize daily energetic requirements. Since animals often live in environments that experience heterogeneous conditions with patchily distributed resources, they may modify their daily movements and behaviors in response to prey availability, environmental conditions, and their exposure to predation risk \u20134. ThereARS has been demonstrated across a wide range of taxa of varying body sizes including insects , 13, birMarine predators, such as coastal elasmobranchs , exhibit a wide variety of movement patterns and behavioral strategies in order to maximize fitness over several spatial  and temporal  scales \u201324. Non-10) of an ectotherm will determine the extent of how dynamic thermal conditions may allow them to remain in their current environment or cause them to move and seek out more suitable thermal conditions [As ectotherms, water temperature is known to be a key abiotic factor that influences elasmobranch physiology and movement patterns \u201331. The nditions , 32\u201334. nditions . Alternanditions \u201338. Thernditions , 32, 38.Measuring animal movements in a marine environment is typically done with acoustic or satellite telemetry \u201342. AlthHeterodontus francisci) were used as a model species to represent non-obligate ram ventilating elasmobranchs. California horn sharks (herein \u201chorn sharks\u201d) are small (<\u20091\u2009m), nocturnally active, and relatively abundant residents in temperate Northeast Pacific rocky reef kelp beds [In the present study, California horn sharks  were continuously actively tracked using acoustic telemetry at Santa Catalina Island, California : 40\u2009mm\u2009\u00d7\u200928\u2009mm\u2009\u00d7\u200917\u2009mm, 19.5\u2009g in air, 5.2\u2009g in seawater; or TechnoSmArt (n\u2009=\u200912) Axy-Depth: 12\u2009mm\u2009\u00d7\u200931\u2009mm\u2009\u00d7\u200911\u2009mm, 6.5\u2009g in air)  (ESRI). Modelling and statistical analyses were done in R (vers. 3.5.2) . For most analyses, data were analyzed in 24\u2009h diel cycles, separated into daytime and nighttime periods using the king day .adehabitatHR package [lme4 package in R [p-values, we used the Anova function in the car package with Type II Wald Chi-square tests [For spatial movement analyses, geo-positions derived from active tracking were filtered to only include detections of highest positional accuracy . To estimate two-dimensional (2D) activity space for each individual, Brownian bridge kernel utilization distributions (BBKUDs) were calculated in R with the  package . By usin package . The BBK package . Daytimeage in R , 63 werere tests , 65.adehabitatLT package in R [max) to be 20 to ensure all possible segments would be accounted. The ideal number of segments for each sharks\u2019 trajectory (Kopt) was determined by choosing the last value of K for which the second derivative D(k) of the standardized contrast function was greater than the threshold of S\u2009=\u20090.75 [opt varied from 2 to 7 segments across nighttime periods. Each Lavielle segment that indicated ARS was then imported into ArcGIS where they were visually assessed and minimum convex polygons (MCPs) were used to calculate the 2D area of the patch. Linear distances (km) travelled to and from a patch were measured in ArcGIS using 1) the centroid of the daytime resting shelter (obtained from the daytime 50% BBKUD) to the centroid of the ARS patch, 2) centroids in between ARS patches , and 3) the distance from the centroid of the last ARS patch used to the next morning\u2019s daytime shelter site. LME models were used to statistically test if there was a significant relationship between the time spent in a patch (response) and the\u00a0area of a\u00a0patch, distance travelled to get to a patch, or activity within a patch . We conducted three separate LME models to determine how each predictor alone influenced time spent within a patch. Time spent in a patch (response) was the total time (min) spent within each patch and was calculated from the start and end times of patch use from the FPT analysis. To account for temporal autocorrelation associated with time spent, we included the number of patches per individual per night as another predictor in each model. Individual was included as a random effect, and p-values were obtained with the Anova function from the car package with Type II Wald Chi-square tests [To identify the scale and location of potential patches via area restricted search (ARS) patterns, a first passage time (FPT) analysis was performed using the age in R . The FPTage in R , 14, 15.age in R . We onlyage in R . For theage in R  to identage in R , 68. We re tests , 65. To re tests .+) or every 25\u2009Hz (Technosmart AxyDepth). All acceleration data were processed in IgorPro  and analyses were conducted using Ethographer [ADLs recorded tri-axial acceleration data at 25\u2009Hz and temperature and depth every 1\u2009Hz , a spectrum analysis was generated using a continuous wavelet transformation with the Morlet wavelet function using the sway axis to quantify the periodicity and intensity of the acceleration signals , 74 Add. A periothan one , 26. Usithan one . Binary k-means analysis were used to estimate and classify activity patterns within ARS patches. Using the FPT analysis above  times of patch use were acquired and used to find related periods of activity. For each identified patch, binary activity values were used to estimate the percent of time spent resting within a patch to first classify patches as resting (95% majority) or active. ODBA and depth within a patch were then visually assessed in IgorPro to further classify patch activity patterns. Resting patches were confirmed by observing low ODBA values (<\u20090.2\u2009g) and no discernible changes in depth throughout the entire duration of patch activity. Active patches were identified by comparatively higher ODBA values (>\u20090.5\u2009g), indicating periods of swimming tail beats or bursts of activity. From these assessments , we identified three classifications of patch activity patterns including 1) resting , 2) episodic burst activity , and 3) active . Resting patches were removed from further patch statistical analyses because we could not confidently determine whether the shark was truly using a patch  yet spending a majority of the time motionless, or if the shark was instead inattentively refuging in a shelter.In addition, binary activity values from the mgcv package in R [mgcv package to ensure proper fit [To determine diel and environmental drivers in nighttime activity patterns (ODBA), we used general additive mixed models (GAMMs) using the age in R . GAMMs wage in R , 72, 79.oper fit , 79.n\u2009=\u20098), Isthmus Reef , Bird Rock , and Campgrounds  , females spent 88.1\u2009\u00b1\u20091.3% of the day resting and 48.9\u2009\u00b1\u20093.1% of the night resting. Similarly, males spent 93.3\u2009\u00b1\u20092.2% of the day resting and 55.02\u2009\u00b1\u20093.47% of the night resting. We chose to not remove any acceleration data as most of our statistical analyses were performed on nighttime periods only. However, it is important to note the tagging day often had periods of increased ODBA  compared to subsequent daytime periods after the tagging day . This increase in activity on the day of tagging was likely due to individuals being unaccustomed to the tag package. Since sharks were tagged during the morning, we assumed that by sunset, individuals had become accustomed to the tag package and nighttime activity was unaffected. This was further confirmed by no differences in activity patterns during the nights for individuals tagged for 48\u2009h .Sharks rested in depths 0.2\u201335\u2009m 15\u2009\u00b1\u20091.4\u2009m) during the day. As a shark remained resting in a shelter during the day, ambient water temperatures changed  approximately 3.3\u2009\u00b1\u20090.3\u2009\u00b0C around them and ranged from 11.0\u201323.0\u2009\u00b0C (18.1\u2009\u00b1\u20092.3\u2009\u00b0C). In contrast, sharks experienced a mean temperature range of approximately 7.4\u2009\u00b1\u20090.4\u2009\u00b0C while traveling throughout the night. In addition, during the night, sharks travelled through depths ranging from 1 to 112\u2009m (19\u2009\u00b1\u200915\u2009m) and through temperatures from 10.0\u201323.8\u2009\u00b0C  and 0.00006\u20130.0096\u2009km2  and 0.00005\u20130.025\u2009km2 .Daytime BBKUDs ranged between 0.00028\u20130.0699\u2009kmn\u2009=\u200917 sharks). Based on the results of the k-means binary activity values and the visual confirmation of ODBA, five patches (13%) were removed from further statistical analyses. Two additional patches were removed because their spatial characteristics were not consistent with our definition of a patch, leaving a total of 31 patches (n\u2009=\u200916 sharks) for further analysis  and the linear distance travelled to get to a patch ranged from 21 to 1747\u2009m (450\u2009\u00b1\u2009484\u2009m). For most (79%) nighttime periods, a single patch was used, and only a few nights (21%) showed individuals used multiple patches (max: 3 patches per night).A total of 38 patches were identified from the 27 nighttime periods analyzed , or the activity (% spent resting) in a patch   , approximately 3.5\u2009\u00b1\u20092.4\u2009h after sunset. Once an individual had found a patch, it spent 0.2\u20137.5\u2009h (2.3\u2009\u00b1\u20092.0\u2009h) in the patch. Individuals that used more than one patch throughout the night spent 2.0\u2009\u00b1\u20091.3\u2009h travelling in between patches. All individuals left their last patch 3.5\u2009\u00b1\u20092.6\u2009h before sunrise, at approximately 04:03  to then travel to their next daytime resting location. All sharks travelled from a final patch to a daytime resting shelter, so final patches were never the same as the final resting location. There was no significant relationship between the time spent in a patch and the distance travelled to get to a patch  was 0.182\u2009km2. Therefore, the resulting area overlap of patch space to core activity space was 0.072\u2009km2, which amounted to an 84.7% overlap  was IR   peaked around 21:00 and 03:30  Fig.\u00a0a, which 01) Fig.\u00a0a, b. AddThis study combined high-resolution spatial movement and acceleration data to understand the fine-scale movement and activity patterns of a non-obligate ram ventilating elasmobranch. There was high individual variation across movement paths, regardless of where or when individuals were tagged, yet nocturnal activity and search modes  were consistent across individuals. All individuals rested in a shelter from sunrise to sunset, then departed their shelters at sunset in search of a resource patch. Acceleration data revealed that all individuals arrived and departed patches at similar times, regardless of size, sex, tagging location, or patch reef. Additionally, nighttime activity (ODBA) was strongly correlated  to patch arrival and departure times, demonstrating bimodal peaks in activity representing the energetic costs of traversing through the relatively deeper (~\u200930\u2009m), cooler channels in between reefs. Once individuals were in a patch, there was an overall reduction in ODBA, likely because periods of inactivity were interspersed with periods of activity  and due to travel speeds decreasing within a patch , 19.Thalossoica antarctica). They found the petrels would use a hierarchical search strategy and move their large-scale search areas in response to seasonally varying densities and the spatial dynamics of Antarctic krill (Euphausia superba).While it is unclear from our results what exactly was influencing the timing of patch behaviors, our activity classification within a patch  allows us to hypothesize what behaviors are potentially driving horn shark movement patterns. Moderate activity within a patch may be indicative of prey or shelter searching, and episodic burst activity may be indicative of foraging or predator evasions, both of which could be energetically costly behaviors for these demersal sharks . TherefoMirounga leonina) first use prior knowledge of predictable areas to drive large-scale movements, then secondarily use ARS to focus their search once in a profitable area [Visually, there was some overlap in ARS patches among individuals indicating an overlap of \u2018search effort\u2019, which may indicate areas where foraging success was greatest . We founble area . Additioble area . Most ofble area . Howeverble area , 52.The overlapping search effort of the patches occurred on a few key reefs, suggesting those reefs are potentially profitable habitat and \u2018activity hotspots\u2019 , 42. It Carcharhinus limbatus), were using less productive habitats to avoid predators. Therefore, determining the ultimate motivation behind ARS behaviors, although difficult, is critical to correctly interpreting movement path structures.Although we hypothesize foraging efforts and patchy prey distributions are the likely drivers of patch use, other behaviors could have equally resulted in the observed ARS movement paths. For instance, while patches characterized as episodic burst activity (48% of active patches) may have been indicative of successful foraging attempts, predator evasions could have also produced the ODBA signatures observed in these patches . Horn shPristis pristis) increase activity during crepuscular and nocturnal periods, regardless of thermal environment [Carcharhinus amblyrhynchos) had an insignificant effect on routine metabolic rates (RMRs) at the diel scale, and instead diel changes in RMRs were driven by swim speeds [Surprisingly, our work found no correlation between ODBA and water temperature for these ectothermic elasmobranchs. While average nighttime activity was highest when individuals were traveling in relatively deeper, cooler channels in between reefs, it was not apparent from these results that horn sharks were purposely seeking an energetic advantage of moving through cooler water to minimize activity costs , 102. Siironment . While sironment . Additiom speeds .10 (2.01), demonstrating that they are relatively thermally insensitive. This may explain why we saw no clear pattern between activity and temperature, yet we did see clear patterns in diel activity. However, it is important to note Luongo and Lowe [Luongo and Lowe  determinand Lowe  additionand Lowe , 35. FurThis study provides one of the largest fine-scale, high-resolution paired data sets available for an elasmobranchmovement ecology study. We demonstrate that horn sharks exhibited ARS movement patterns and displayed various activity patterns within ARS patches. Our work found that horn shark movements and activity patterns are not reliant upon environmental temperature, indicating they may instead focus their movements by traveling to reefs known to have profitable and predictable patches. As nocturnal, hard prey  specialists known to be annual residents in rocky reef communities, horn sharks may be ecologically important regulators of lower trophic level invertebrates, potentially responsible for regulating kelp bed community structure , 104\u2013107Additional file 1. Acceleration summaries for actively tracked California horn sharks (Heterodontus francisci). Mean values for ODBA , temperature (\u00b0C), and depth (m) for each 24\u2009h period for each California horn shark tracked.Additional file 2. Example of k-means cluster analysis. Example of how k-means clusters were derived from the acceleration ethogram in IgorPro using Ethographer . Clusters were then used to quantify if California horn sharks were resting or active.Additional file 3. Diel comparisons of Brownian bridge kernel utilization distributions (BBKUDs). Diel comparisons of Brownian bridge kernel utilization distributions (BBKUDs) for California horn sharks for both 95% (daily) and 50% (core) activity spaces estimates.", "texts": ["Heterodontus francisci) are nocturnally active, non-obligate ram ventilating sharks in rocky reef habitats that play an important ecological role in regulating invertebrate communities. We predicted horn sharks would use an area restricted search (ARS) movement strategy to locate dense resource patches while minimizing energetic costs of travel and nighttime activity. As ectotherms, we predicted environmental temperature would play a significant role in driving movement and activity patterns.California horn sharks  as a proxy for energy expenditure. Behavior within a patch was characterized into three activity patterns: resting, episodic burst activity, and moderate, consistent activity.After resting in daytime shelters, individuals travelled to multiple reefs throughout the night, traversing through depths of 2\u2013112\u2009m and temperatures of 10.0\u201323.8\u2009\u00b0C. All sharks exhibited area restricted search patch use and arrived at their first patch approximately 3.4\u2009\u00b1\u20092.2\u2009h (mean\u2009\u00b1\u2009SD) after sunset. Sharks exhibited moderate, consistent activity in 54% of the patches used, episodic burst activity in 33%, and few (13%) were identified as resting at night. ODBA peaked while sharks were swimming through relatively deeper (~\u200930\u2009m), colder channels when traversing from one patch to the next. There was no consistent pattern between ODBA and temperature.We provide one of the largest fine-scale, high-resolution paired data sets for an elasmobranch movement ecology study. Horn sharks exhibited ARS movement patterns for various activity patterns. Individuals likely travel to reefs known to have profitable and predictable patches, potentially tolerating less suitable environmental temperatures. We demonstrate how gathering high-resolution information on the movement decisions of a community resident enhances knowledge of community structure and overall ecosystem function. Mobile animals across all taxa make daily movement decisions to optimize daily energetic requirements. Since animals often live in environments that experience heterogeneous conditions with patchily distributed resources, they may modify their daily movements and behaviors in response to prey availability, environmental conditions, and their exposure to predation risk \u20134. ThereARS has been demonstrated across a wide range of taxa of varying body sizes including insects , 13, birMarine predators, such as coastal elasmobranchs , exhibit a wide variety of movement patterns and behavioral strategies in order to maximize fitness over several spatial  and temporal  scales \u201324. Non-10) of an ectotherm will determine the extent of how dynamic thermal conditions may allow them to remain in their current environment or cause them to move and seek out more suitable thermal conditions [As ectotherms, water temperature is known to be a key abiotic factor that influences elasmobranch physiology and movement patterns \u201331. The nditions , 32\u201334. nditions . Alternanditions \u201338. Thernditions , 32, 38.Measuring animal movements in a marine environment is typically done with acoustic or satellite telemetry \u201342. AlthHeterodontus francisci) were used as a model species to represent non-obligate ram ventilating elasmobranchs. California horn sharks (herein \u201chorn sharks\u201d) are small (<\u20091\u2009m), nocturnally active, and relatively abundant residents in temperate Northeast Pacific rocky reef kelp beds [In the present study, California horn sharks  were continuously actively tracked using acoustic telemetry at Santa Catalina Island, California : 40\u2009mm\u2009\u00d7\u200928\u2009mm\u2009\u00d7\u200917\u2009mm, 19.5\u2009g in air, 5.2\u2009g in seawater; or TechnoSmArt (n\u2009=\u200912) Axy-Depth: 12\u2009mm\u2009\u00d7\u200931\u2009mm\u2009\u00d7\u200911\u2009mm, 6.5\u2009g in air)  (ESRI). Modelling and statistical analyses were done in R (vers. 3.5.2) . For most analyses, data were analyzed in 24\u2009h diel cycles, separated into daytime and nighttime periods using the king day .adehabitatHR package [lme4 package in R [p-values, we used the Anova function in the car package with Type II Wald Chi-square tests [For spatial movement analyses, geo-positions derived from active tracking were filtered to only include detections of highest positional accuracy . To estimate two-dimensional (2D) activity space for each individual, Brownian bridge kernel utilization distributions (BBKUDs) were calculated in R with the  package . By usin package . The BBK package . Daytimeage in R , 63 werere tests , 65.adehabitatLT package in R [max) to be 20 to ensure all possible segments would be accounted. The ideal number of segments for each sharks\u2019 trajectory (Kopt) was determined by choosing the last value of K for which the second derivative D(k) of the standardized contrast function was greater than the threshold of S\u2009=\u20090.75 [opt varied from 2 to 7 segments across nighttime periods. Each Lavielle segment that indicated ARS was then imported into ArcGIS where they were visually assessed and minimum convex polygons (MCPs) were used to calculate the 2D area of the patch. Linear distances (km) travelled to and from a patch were measured in ArcGIS using 1) the centroid of the daytime resting shelter (obtained from the daytime 50% BBKUD) to the centroid of the ARS patch, 2) centroids in between ARS patches , and 3) the distance from the centroid of the last ARS patch used to the next morning\u2019s daytime shelter site. LME models were used to statistically test if there was a significant relationship between the time spent in a patch (response) and the\u00a0area of a\u00a0patch, distance travelled to get to a patch, or activity within a patch . We conducted three separate LME models to determine how each predictor alone influenced time spent within a patch. Time spent in a patch (response) was the total time (min) spent within each patch and was calculated from the start and end times of patch use from the FPT analysis. To account for temporal autocorrelation associated with time spent, we included the number of patches per individual per night as another predictor in each model. Individual was included as a random effect, and p-values were obtained with the Anova function from the car package with Type II Wald Chi-square tests [To identify the scale and location of potential patches via area restricted search (ARS) patterns, a first passage time (FPT) analysis was performed using the age in R . The FPTage in R , 14, 15.age in R . We onlyage in R . For theage in R  to identage in R , 68. We re tests , 65. To re tests .+) or every 25\u2009Hz (Technosmart AxyDepth). All acceleration data were processed in IgorPro  and analyses were conducted using Ethographer [ADLs recorded tri-axial acceleration data at 25\u2009Hz and temperature and depth every 1\u2009Hz , a spectrum analysis was generated using a continuous wavelet transformation with the Morlet wavelet function using the sway axis to quantify the periodicity and intensity of the acceleration signals , 74 Add. A periothan one , 26. Usithan one . Binary k-means analysis were used to estimate and classify activity patterns within ARS patches. Using the FPT analysis above  times of patch use were acquired and used to find related periods of activity. For each identified patch, binary activity values were used to estimate the percent of time spent resting within a patch to first classify patches as resting (95% majority) or active. ODBA and depth within a patch were then visually assessed in IgorPro to further classify patch activity patterns. Resting patches were confirmed by observing low ODBA values (<\u20090.2\u2009g) and no discernible changes in depth throughout the entire duration of patch activity. Active patches were identified by comparatively higher ODBA values (>\u20090.5\u2009g), indicating periods of swimming tail beats or bursts of activity. From these assessments , we identified three classifications of patch activity patterns including 1) resting , 2) episodic burst activity , and 3) active . Resting patches were removed from further patch statistical analyses because we could not confidently determine whether the shark was truly using a patch  yet spending a majority of the time motionless, or if the shark was instead inattentively refuging in a shelter.In addition, binary activity values from the mgcv package in R [mgcv package to ensure proper fit [To determine diel and environmental drivers in nighttime activity patterns (ODBA), we used general additive mixed models (GAMMs) using the age in R . GAMMs wage in R , 72, 79.oper fit , 79.n\u2009=\u20098), Isthmus Reef , Bird Rock , and Campgrounds  , females spent 88.1\u2009\u00b1\u20091.3% of the day resting and 48.9\u2009\u00b1\u20093.1% of the night resting. Similarly, males spent 93.3\u2009\u00b1\u20092.2% of the day resting and 55.02\u2009\u00b1\u20093.47% of the night resting. We chose to not remove any acceleration data as most of our statistical analyses were performed on nighttime periods only. However, it is important to note the tagging day often had periods of increased ODBA  compared to subsequent daytime periods after the tagging day . This increase in activity on the day of tagging was likely due to individuals being unaccustomed to the tag package. Since sharks were tagged during the morning, we assumed that by sunset, individuals had become accustomed to the tag package and nighttime activity was unaffected. This was further confirmed by no differences in activity patterns during the nights for individuals tagged for 48\u2009h .Sharks rested in depths 0.2\u201335\u2009m 15\u2009\u00b1\u20091.4\u2009m) during the day. As a shark remained resting in a shelter during the day, ambient water temperatures changed  approximately 3.3\u2009\u00b1\u20090.3\u2009\u00b0C around them and ranged from 11.0\u201323.0\u2009\u00b0C (18.1\u2009\u00b1\u20092.3\u2009\u00b0C). In contrast, sharks experienced a mean temperature range of approximately 7.4\u2009\u00b1\u20090.4\u2009\u00b0C while traveling throughout the night. In addition, during the night, sharks travelled through depths ranging from 1 to 112\u2009m (19\u2009\u00b1\u200915\u2009m) and through temperatures from 10.0\u201323.8\u2009\u00b0C  and 0.00006\u20130.0096\u2009km2  and 0.00005\u20130.025\u2009km2 .Daytime BBKUDs ranged between 0.00028\u20130.0699\u2009kmn\u2009=\u200917 sharks). Based on the results of the k-means binary activity values and the visual confirmation of ODBA, five patches (13%) were removed from further statistical analyses. Two additional patches were removed because their spatial characteristics were not consistent with our definition of a patch, leaving a total of 31 patches (n\u2009=\u200916 sharks) for further analysis  and the linear distance travelled to get to a patch ranged from 21 to 1747\u2009m (450\u2009\u00b1\u2009484\u2009m). For most (79%) nighttime periods, a single patch was used, and only a few nights (21%) showed individuals used multiple patches (max: 3 patches per night).A total of 38 patches were identified from the 27 nighttime periods analyzed , or the activity (% spent resting) in a patch   , approximately 3.5\u2009\u00b1\u20092.4\u2009h after sunset. Once an individual had found a patch, it spent 0.2\u20137.5\u2009h (2.3\u2009\u00b1\u20092.0\u2009h) in the patch. Individuals that used more than one patch throughout the night spent 2.0\u2009\u00b1\u20091.3\u2009h travelling in between patches. All individuals left their last patch 3.5\u2009\u00b1\u20092.6\u2009h before sunrise, at approximately 04:03  to then travel to their next daytime resting location. All sharks travelled from a final patch to a daytime resting shelter, so final patches were never the same as the final resting location. There was no significant relationship between the time spent in a patch and the distance travelled to get to a patch  was 0.182\u2009km2. Therefore, the resulting area overlap of patch space to core activity space was 0.072\u2009km2, which amounted to an 84.7% overlap  was IR   peaked around 21:00 and 03:30  Fig.\u00a0a, which 01) Fig.\u00a0a, b. AddThis study combined high-resolution spatial movement and acceleration data to understand the fine-scale movement and activity patterns of a non-obligate ram ventilating elasmobranch. There was high individual variation across movement paths, regardless of where or when individuals were tagged, yet nocturnal activity and search modes  were consistent across individuals. All individuals rested in a shelter from sunrise to sunset, then departed their shelters at sunset in search of a resource patch. Acceleration data revealed that all individuals arrived and departed patches at similar times, regardless of size, sex, tagging location, or patch reef. Additionally, nighttime activity (ODBA) was strongly correlated  to patch arrival and departure times, demonstrating bimodal peaks in activity representing the energetic costs of traversing through the relatively deeper (~\u200930\u2009m), cooler channels in between reefs. Once individuals were in a patch, there was an overall reduction in ODBA, likely because periods of inactivity were interspersed with periods of activity  and due to travel speeds decreasing within a patch , 19.Thalossoica antarctica). They found the petrels would use a hierarchical search strategy and move their large-scale search areas in response to seasonally varying densities and the spatial dynamics of Antarctic krill (Euphausia superba).While it is unclear from our results what exactly was influencing the timing of patch behaviors, our activity classification within a patch  allows us to hypothesize what behaviors are potentially driving horn shark movement patterns. Moderate activity within a patch may be indicative of prey or shelter searching, and episodic burst activity may be indicative of foraging or predator evasions, both of which could be energetically costly behaviors for these demersal sharks . TherefoMirounga leonina) first use prior knowledge of predictable areas to drive large-scale movements, then secondarily use ARS to focus their search once in a profitable area [Visually, there was some overlap in ARS patches among individuals indicating an overlap of \u2018search effort\u2019, which may indicate areas where foraging success was greatest . We founble area . Additioble area . Most ofble area . Howeverble area , 52.The overlapping search effort of the patches occurred on a few key reefs, suggesting those reefs are potentially profitable habitat and \u2018activity hotspots\u2019 , 42. It Carcharhinus limbatus), were using less productive habitats to avoid predators. Therefore, determining the ultimate motivation behind ARS behaviors, although difficult, is critical to correctly interpreting movement path structures.Although we hypothesize foraging efforts and patchy prey distributions are the likely drivers of patch use, other behaviors could have equally resulted in the observed ARS movement paths. For instance, while patches characterized as episodic burst activity (48% of active patches) may have been indicative of successful foraging attempts, predator evasions could have also produced the ODBA signatures observed in these patches . Horn shPristis pristis) increase activity during crepuscular and nocturnal periods, regardless of thermal environment [Carcharhinus amblyrhynchos) had an insignificant effect on routine metabolic rates (RMRs) at the diel scale, and instead diel changes in RMRs were driven by swim speeds [Surprisingly, our work found no correlation between ODBA and water temperature for these ectothermic elasmobranchs. While average nighttime activity was highest when individuals were traveling in relatively deeper, cooler channels in between reefs, it was not apparent from these results that horn sharks were purposely seeking an energetic advantage of moving through cooler water to minimize activity costs , 102. Siironment . While sironment . Additiom speeds .10 (2.01), demonstrating that they are relatively thermally insensitive. This may explain why we saw no clear pattern between activity and temperature, yet we did see clear patterns in diel activity. However, it is important to note Luongo and Lowe [Luongo and Lowe  determinand Lowe  additionand Lowe , 35. FurThis study provides one of the largest fine-scale, high-resolution paired data sets available for an elasmobranchmovement ecology study. We demonstrate that horn sharks exhibited ARS movement patterns and displayed various activity patterns within ARS patches. Our work found that horn shark movements and activity patterns are not reliant upon environmental temperature, indicating they may instead focus their movements by traveling to reefs known to have profitable and predictable patches. As nocturnal, hard prey  specialists known to be annual residents in rocky reef communities, horn sharks may be ecologically important regulators of lower trophic level invertebrates, potentially responsible for regulating kelp bed community structure , 104\u2013107Additional file 1. Acceleration summaries for actively tracked California horn sharks (Heterodontus francisci). Mean values for ODBA , temperature (\u00b0C), and depth (m) for each 24\u2009h period for each California horn shark tracked.Additional file 2. Example of k-means cluster analysis. Example of how k-means clusters were derived from the acceleration ethogram in IgorPro using Ethographer . Clusters were then used to quantify if California horn sharks were resting or active.Additional file 3. Diel comparisons of Brownian bridge kernel utilization distributions (BBKUDs). Diel comparisons of Brownian bridge kernel utilization distributions (BBKUDs) for California horn sharks for both 95% (daily) and 50% (core) activity spaces estimates."]}
{"representative": "This article presents an experience of deploying an integrated performance management system as a catalyst for the integration of a service trajectory for children in vulnerable situations. Called \u2018\u2018Jimmy\u2019\u2019, the project identifies how the integrated performance management system makes it possible to improve accessibility, continuity of services and well-being at work among stakeholders.An action research was conducted in a large healthcare organization in Canada, between August 2016 and October 2018. Data was systematically collected throughout the various cycles of research using field notes, more than 350 hours of observations, 15 interviews and 3 focus groups.This research supports using an integrated performance management system as a model for collaborative management that supports both horizontal and vertical integration in the service trajectory. The use of visual boards and status sheet meetings were determining factors for service integration and the functioning of integrated teams. This also led to improvements in accessibility and continuity of services, as well as in employee well-being.Supported by the various tools of the integrated performance management system, Project \u2018\u2018Jimmy\u2019\u2019 reinforces the implementation of linkage and coordination models, which in turn helps create strong connections among teams. The status sheet meetings and visual boards are tools that vertically integrate different hierarchical levels and horizontally integrate various front-line stakeholders through the user-oriented trajectory. In recent decades, many industrialised countries have made significant reforms to their health care systems, which has led to the implementation of integration mechanisms . For exaIn the wave of this change, the Quebec ministry of health and social services showed a strong desire to improve performance through the implementation of management tools. One target in its strategic planning  was the \u201cBy March 31, 2018, all institutions will have deployed their strategic control room and on March 31, 2020, organisations must have deployed 80% of their tactical and operational control rooms.\u201d2. This territory has experienced significant population decline and low population density, which are sources of concern when it comes to service continuity for children, youth and families. Like many regions in Quebec, the territory served by the IHSSC studied here is experiencing a demographic decline and has a low population density. These appear to be contributing factors in the review of how services are organized in their current form. This territory also has challenges when it comes to updating programs or services for youth. The insufficient pool of target clients combined with the risks of social stigma associated with marginalized groups may constitute barriers to implementing programs for family clients.This article aims to ascertain how service integration processes are improved through the adoption of an integrated performance management system. This action research was carried out in IHSSC and specifically in the centre\u2019s programmes for children, youth and families. In the 2015 reform, this IHSSC was created through the merger of 7 institutions that included 49 facilities spread out over more than 20,000 kmThis action research, which took place over more than two years, contributes to the literature by demonstrating the operational strength of the tools of the integrated performance management system (IPMS) to answer the following question: \u201cWhich integrated performance system tools support the integration of social services for children and their families?\u201d The literature is scant on which integrated performance management system tools foster the integration of services for a target clientele. This article aims to fill this gap.Services can be integrated either vertically or horizontally 3438. Hor3455610Leutz  places tAlthough the tools of the integrated performance management system (particularly the control rooms) have been deployed in Quebec, few studies significantly demonstrate how these rooms add value to integrating care and services for a target clientele. This paper addresses this shortcoming by exploring the integrated performance management system tools that support better vertical and horizontal integration, particularly in programs for children, youth and families.The integrated performance management system currently deployed in Quebec\u2019s health and social services network may be considered a key to the integration of services. This system is supported by a management philosophy based on continuous improvement and consists of a coherent set of standardised and coordinated principles, practices and tools that, through shared leadership, help an institution achieve clearly stated organisational objectives that aim to create value for all stakeholders.Organizational performance requires a performance management model that establishes a basis for organizational governance and a framework for how managers should make decisions when it comes to creating and distributing value in the organization . A leadiTo that end, performance assessment needs to consider multiple criteria necessary for the organization to find balance. Central to this notion is the quadruple aim  to assesThe tools and practices used for this action research were kaikaku, A3 reports, kaizen, control rooms, status sheets and kata.Kaikaku is a Japanese word that translates as \u201cradical change\u201d and is seen as a process that can generate significant results when existing practices are replaced with new ones . KaikakuThe A3 report is a summary document that conveys information about projects on a single A3-sized sheet (11 \u00d7 17 inches format in North America) on which a problem-solving approach is expressed in a structured way . There iKaizen means a \u201cchange for the better\u201d and thus translates continuous improvement into a problem-solving process . This apControl rooms, or obeya in Japanese, are places where team members can meet to assess current performance in a dynamic way and engage in discussion to support future performance 3044. Con3039The status sheet represents a standardised dialogue between an employee and his or her immediate superior. The sheet helps the employee learn about and better understand the organisation\u2019s operations and prevent potential problems within a trajectory. A status sheet meeting is facilitated by a senior administrator from the management committee based on status sheets from the field.Kata are small, structured practice routines. Learning and then combining these individual practice routines is a way of developing competency in the overall way or pattern of doing something . It is iFigure 1 synthesizes these various tools and how they are linked within the organization.All of these tools use the Plan, Do, Check, Adjust (PDCA) problem-solving cycle popularised by Deming . Figure This study uses action research, which consists of generating scientific knowledge to better understand and change the social reality of individuals . This ty17This action research was carried out between June 2016 and October 2018. More than 350 hours of data collection was performed to create field notes taken from semi-structured interviews, focus groups and participant observation. Semi-structured interviews were conducted at the participants\u2019 workplace with four psychosocial workers, six senior administrators, and five middle managers. Each interview lasted between 60 and 90 minutes and was conducted using a semi-structured interview guide. The questions aimed to ascertain what happened and why it happened (diagnosis) and what could have been done differently (reflection). Saturation was reached once the themes and categories became repetitive or no longer provided new or different information .The data analysis strategies led to a detailed description of the various sources, including a full transcript of the content of all individual interviews from the audio recordings. These strategies related to grounded theory include three main coding steps: open coding, axial coding and selective coding .Three 90-minutes focus groups were also conducted in October 2018 based on the organisation\u2019s hierarchical logic, i.e., strategic, tactical and operational. The focus groups were largely based on the learning history approach . A documAdditionally, over 350 hours of data was recorded in field notes from non-participant observations during different interdisciplinary meetings and during strategic, tactical and operational steering-room activities. The field notes were helpful for recording relevant information throughout the data collection period and were also useful for interpreting observations .The adopted methodology minimized the risks of bias thanks to in-depth knowledge of the study setting and great attention paid to the methodology employed . To asseThe research project was approved by the Research and Ethics Committee of the Universit\u00e9 du Qu\u00e9bec \u00e0 Trois-Rivi\u00e8res (No. CER-18-244-07.01).Table 1 presents a summary of the results. Each phase of the PDCA cycle touches upon the types of intervention used for the tools of the integrated performance management system and the results obtained for the service integration project. However, some phases may have overlapped due to the cyclical process of the research.The results are presented based on the cyclical logic structured by the PDCA and action research methodology. In June 2016, senior managers invited 4 middle managers from the integrated youth teams and 4 senior managers to a kaikaku event and to an initial activity whose goal was to improve coordination between the youth programmes directorate and youth protection directorate. The meeting took place over two days.At the start of the kaikaku, senior managers conveyed a very clear vision as part of a true client-centred strategy :A child will never suffer alone.A child will always be supported in his or her pathway.Do the impossible to avoid putting the development or safety of a child in danger. (Children must receive the full range of services to ensure their development and safety.)Internal partners  and external partners were asked to contribute at a later date. As one staff member explained:\u201cJimmy\u201d is not just young; he has other needs too. He may have impairments and be autistic as well [\u2026].\u201dPrior to the kaikaku, the continuous improvement specialist documented the actual service pathway of a child and the child\u2019s family. The initial service request was for a language impairment detected by a perinatal nurse when the child was 20 months old. The last intervention noted in the child\u2019s record was a report that was under assessment, even though the child was almost 10 years old. First, the continuous improvement specialist documented response times, number of staff members, number of interventions, etc. The Chief Executive Officer (CEO) believes that it would have been useful to invite a child or their parents to participate in the service integration project. Nevertheless, two obstacles quickly became apparent. The first stemmed from the merger of 7 institutions and a new culture of collaboration that had to be created among different partners. The second related to the confidentiality of reported situations and the need to manage the risks of social stigmatization given the territory\u2019s minimal client base .A major concern for the kaikaku participants was simplifying the child\u2019s pathway through services. As youths in difficulty are truly at the heart of the integration project, the managers decided to give the project the name of a child\u2014 \u201cJimmy\u201d\u2014so that everyone saw this child as a real partner. The CEO stated that the kaikaku gave the project momentum:\u201cAfter doing the kaikaku, we made a radical change and stayed focused on our goal.\u201dThe use of the A3 reports on the second day to deploy the integration project helped clarify the performance indicators that could improve service accessibility and continuity for the target clientele and each manager at the session signed it as a formal commitment to carry out and help implement the process. A member of the management team said:\u201cThe A3 reports allowed people who were supposed to contribute to the project to reflect on the project [\u2026.] when the managers signed the collaboration contract at the beginning of the project  that\u2019s when people really became engaged.\u201dFour kaizen workshops required more tactical and operational approaches and the idea was not to establish complete integration for each youth but rather to reflect on a trajectory that could be adjusted based on the profiles of each little \u201cJimmy\u201d in the territory. The performance indicators were tracked in the tactical control room and in the multiple operational control rooms of the integrated teams.Despite the A3 tracking in the strategic control room, the integration project encountered issues that seriously impeded the integration project. Difficulties arising from the leadership of the senior managers of the different youth directorates hindered cooperation between the two sectors involved in the integration project. According to Kodner and Kyriacou , weak in\u201cIn some situations, we are still working in silos. We can\u2019t work on Jimmy\u2019s case on our own; these are young people with service episodes who may be transiently intellectually disabled or experiencing dependency  but all we have to help Jimmy together. The project helps us do that.\u201dThe arrival, in 2018, of two new senior managers with backgrounds in collaborative practices allowed for a single tactical control room to be set up for these two directorates. This was a major innovation. A middle manager had this to say about this innovation:\u201cImplementing the tactical room jointly between the youth program and the youth protection directorate has advantages, such as continuity. The tactical control room mobilized everyone in a new integration context.\u201dThe tactical control room is where the continuum of services required by \u201cJimmy\u201d and any areas of discontinuity identified by the operational control rooms are monitored. The comments of a middle manager support the importance of the tactical control room:\u201cWe have concrete results  we\u2019re taking action and things are happening  there\u2019s follow-up in the other control rooms.\u201dImprovement Kata are an important practice methodology used during activities at operational or visual stations that identify improvement opportunities and next steps based on a PDCA cycle.An example of cooperation and a staff member\u2019s concern for service integration was made through an Improvement Kata in the operational control room. Lack of contact over a long period led to dissatisfaction among foster families who need ongoing support to help a foster child who is coping with personal and family issues. With this approach, the institution can now confirm that all children placed with foster families are met with monthly. \u201cJimmy\u201d no longer suffers alone and is always supported. The target was then set by the integrated youth team.Given the slow progress in the integration project and the lack of results to help Jimmy due to a lack of leadership, in June 2017 the CEO proposed creating a status sheet to better understand and document the trajectory through dialogue between an employee and his or her immediate superior. This new step created an anchor point for a new PDCA cycle. This individual status sheet was added as a complement to the activities in the operational control rooms and aimed to resolve the problems of accessibility, continuity and workplace well-being. Managers received training on the status sheets. Discussions were held to link the status sheets with the goals set out within the strategic A3 reports and the A3 projects. To reinforce this new practice, the CEO relied on the relationship skills of the continuous improvement specialist. The coaching of managers and teams was one reason for Project Jimmy\u2019s success.Within six months, the status sheet helped minimise problems tracking significant indicators meant to improve the targets set at the start of the integration project. This tool opened the door to service integration by getting the other youth directorates involved to alleviate problems related to fragmentation that, in the words of a middle manager, \u201ccould let a Jimmy fall through the cracks.\u201d One manager was impressed by the speed of this tool and said:\u201cFor me, the status sheet was a revelation out of the whole process.\u201dOnce a week, all managers are invited to a conference call with the associate chief executive officer to report on each team\u2019s progress. Called \u201cstatus sheet meetings,\u201d these weekly calls held every Friday between 8:00 a.m. and 9:00 a.m. let staff assess performance in terms of service accessibility and continuity in the trajectory and report on progress made and obstacles encountered since the previous meeting. For example, one question asked at the meeting relates to the number of users who do not show up for their appointments. For each no-show, the staff member is asked to explain why. Another issue relates more to staff well-being: the manager asks the staff member about their perception of their workload, and if the staff member feels overwhelmed, action is taken immediately. Comments from senior manager highlight the potential of this tool of the integrated performance management system:\u201cWithout the status sheet, we would have no links between our control rooms; there would be a piece missing. The status sheet meetings allow staff to see how proactively removing obstacles to operational performance puts \u201cJimmy\u201d at the heart of this approach.\u201dSix months after the status sheet was implemented in complementarity with the control rooms, improvements had been made in relation to targets to enhance service accessibility and continuity. At the start of the integration project, the average time between the assessment and a first intervention was 16.96 days, whereas the ministerial target was 12 days. In November 2017, the average time had decreased to 8.35 days. This significant time reduction helps staff respond more quickly to protect the needs of vulnerable children and prevent their situations from deteriorating. The service intensity, which had been 0.96 interventions per day per worker, improved significantly and rose to 3.6 interventions per day per worker. A 275% improvement over two years indicates improved access to services. Improving service intensity in turn optimizes staff case load and reduces the wait times for families experiencing problems. Clear improvements were also noted in the implementation of intervention plans, for which the ministerial target was 85%, as the results showed an increase in intervention plans from 70% to 85% in a statutory context and from 10% to 43% in a voluntary context. The fact that families can have an intervention plan makes it easier to determine the problem and the best tools to resolve it, which in turn creates better linkage, better coordination, and fuller integration. Finally, the disability insurance rate dropped from 14.30% to 8.70%, which generated substantial savings. When staff return to work, this provides better service continuity for families by ensuring that their services do not become fragmented. In addition to indicator performance, team actions helped fulfill the vision set out during the kaikaku, i.e., that Jimmy will never be alone again.Communication is a major challenge in an organisational integration project . The dep\u201cThere are advantages [\u2026] in our day-to-day reality  as problems crop up [\u2026] and then solutions do too.\u201dThe advantage of using the weekly status sheet to improve \u201cJimmy\u2019s\u201d service trajectory is that it generates quick wins in terms of improved coordination and improved communication at all organisational levels.The goal of this exploratory qualitative study is to explain whether integration is supported by an integrated performance management system, particularly through the deployment of control rooms and the status sheet. At IHSSC, the issue of integration is being addressed through the implementation of a service trajectory that ensures service accessibility and continuity for children, youth and family clients and that improves the well-being of staff to reduce the risk of early attrition.This research supports the idea that the integrated performance management system is a collaborative model for trajectory management and that it can therefore support vertical and horizontal integration 1124. Sig11To improve the use of the strategic control room, it would have been interesting to have visual boards of \u201cJimmy\u2019s\u201d trajectory, with the idea that visual management provides a better understanding of processes, highlights opportunities for improvement, and reduces waste . Visual 7The central component of this integration project has been the implementation of an integrated youth team through strategic, tactical and operational control rooms to offer coordinated services. This action research shows how interdependence was created between the two directorates in particular through the tactical and operational control room thanks to trajectory review meetings that fostered discussions between each directorate\u2019s respective stakeholders and forced them to broaden their knowledge, perspectives and interests. The control rooms and the status sheet became true catalysts for integration. These complementary tools fostered the linkage, coordination and full integration of services for the benefit of children, youth and families. The innovation of deploying a single tactical control room integrating the youth protection directorate and the youth programmes directorate supports better communication and, accordingly, confirms that communication among all stakeholders is a key issue in integration processes .The control rooms and the status sheet reinforced the project proposed by the CEO in 2016 to integrate services for the well-being of the territory\u2019s children, youth and families, which in turn reinforces the idea of complementarity between vertical and horizontal integration 6. For theThe integrated performance management system deployed for the Jimmy project upholds the idea that performance is multidimensional and is contingent on the balanced approach of the quadruple aim model. The various tools resulting from the management model has generated not only financial gains but also gains in the areas of accessibility, continuity and staff engagement. Although lacking at the start of the project, performance measurement saw great progress, as the status sheet consolidated the processes defining the trajectory\u2019s measurable objectives and therefore collected performance data generated by the integration project.Importance of defining the concept of integration during the kaikaku to give the project meaning. The stakeholders of the trajectory must have a better knowledge of an integration continuum.Personalizing the project by naming it \u201cJimmy.\u201d He became the catalyst for the integration project. He participates in the creation of meaning. Each worker who took part in the project had a very clear reference to a \u201cJimmy\u201d in a vulnerable situation in his entourage. The speakers were keen to contribute to Jimmy\u2019s well-being in a more fluid and improved trajectory. There was no fear or resistance to integrating the services.The use of the tools of the integrated performance management system supports the stakeholders on a daily basis. Staff members no longer face the challenges of working with vulnerable clients alone, as they are met with on a weekly basis both through the status sheet and the control room. These tools of the integrated performance management system support active listening and create the conditions for requests to be grouped so that staff can adequately respond to children\u2019s needs through a standardisation of formal communications.The integrated performance management system is first and foremost a collaborative management model supporting the integration and improvement of care and services. The control rooms and the status report demonstrate the proactive action of operational teams in identifying obstacles and solutions to an optimal path to meet customer needs.The creation of a single tactical control room between two complementary departments that supports processes to better coordinate services. Observations from this research suggest that the tactical control room makes any obstacles in the trajectory flow instantly visible to managers. Having staff members participate in the operational control room helps them work together to ensure service access and continuity while drawing from expertise from different areas.Like many institutions in Quebec\u2019s health and social services network, the IHSSC had to improve its performance while tackling the integration challenges posed by the 2015 reform. To face this challenge, the institution decided to deploy an integrated performance management system. Supported by the different tools of the integrated performance management system, the \u201cJimmy\u201d integration project reinforces the implementation of linkage, coordination and full integration models that become strong connections between teams. The status sheet and control room are tools that vertically integrate different hierarchical levels and horizontally integrate various front-line stakeholders through the user-oriented trajectory.Based on this study\u2019s observations, future research avenues could address how an integration project supported by different tools of the integrated performance management system improves employee workplace well-being to ensure accessible and continuous services. Future research could also determine how target indicators change over a longer period and explore the optimal conditions to ensure the organisational sustainability of this type of integration project for different clienteles. Overall, it would be useful to look at the principles of the \u201clearning organization\u201d as part of an organizational transformation that fosters service integration processes. Useful outcomes could also come about through a convergence of the integrated performance management system with organizational capacity to improve results in a context in which practice innovation is encouraged.", "texts": ["This article presents an experience of deploying an integrated performance management system as a catalyst for the integration of a service trajectory for children in vulnerable situations. Called \u2018\u2018Jimmy\u2019\u2019, the project identifies how the integrated performance management system makes it possible to improve accessibility, continuity of services and well-being at work among stakeholders.An action research was conducted in a large healthcare organization in Canada, between August 2016 and October 2018. Data was systematically collected throughout the various cycles of research using field notes, more than 350 hours of observations, 15 interviews and 3 focus groups.This research supports using an integrated performance management system as a model for collaborative management that supports both horizontal and vertical integration in the service trajectory. The use of visual boards and status sheet meetings were determining factors for service integration and the functioning of integrated teams. This also led to improvements in accessibility and continuity of services, as well as in employee well-being.Supported by the various tools of the integrated performance management system, Project \u2018\u2018Jimmy\u2019\u2019 reinforces the implementation of linkage and coordination models, which in turn helps create strong connections among teams. The status sheet meetings and visual boards are tools that vertically integrate different hierarchical levels and horizontally integrate various front-line stakeholders through the user-oriented trajectory. In recent decades, many industrialised countries have made significant reforms to their health care systems, which has led to the implementation of integration mechanisms . For exaIn the wave of this change, the Quebec ministry of health and social services showed a strong desire to improve performance through the implementation of management tools. One target in its strategic planning  was the \u201cBy March 31, 2018, all institutions will have deployed their strategic control room and on March 31, 2020, organisations must have deployed 80% of their tactical and operational control rooms.\u201d2. This territory has experienced significant population decline and low population density, which are sources of concern when it comes to service continuity for children, youth and families. Like many regions in Quebec, the territory served by the IHSSC studied here is experiencing a demographic decline and has a low population density. These appear to be contributing factors in the review of how services are organized in their current form. This territory also has challenges when it comes to updating programs or services for youth. The insufficient pool of target clients combined with the risks of social stigma associated with marginalized groups may constitute barriers to implementing programs for family clients.This article aims to ascertain how service integration processes are improved through the adoption of an integrated performance management system. This action research was carried out in IHSSC and specifically in the centre\u2019s programmes for children, youth and families. In the 2015 reform, this IHSSC was created through the merger of 7 institutions that included 49 facilities spread out over more than 20,000 kmThis action research, which took place over more than two years, contributes to the literature by demonstrating the operational strength of the tools of the integrated performance management system (IPMS) to answer the following question: \u201cWhich integrated performance system tools support the integration of social services for children and their families?\u201d The literature is scant on which integrated performance management system tools foster the integration of services for a target clientele. This article aims to fill this gap.Services can be integrated either vertically or horizontally 3438. Hor3455610Leutz  places tAlthough the tools of the integrated performance management system (particularly the control rooms) have been deployed in Quebec, few studies significantly demonstrate how these rooms add value to integrating care and services for a target clientele. This paper addresses this shortcoming by exploring the integrated performance management system tools that support better vertical and horizontal integration, particularly in programs for children, youth and families.The integrated performance management system currently deployed in Quebec\u2019s health and social services network may be considered a key to the integration of services. This system is supported by a management philosophy based on continuous improvement and consists of a coherent set of standardised and coordinated principles, practices and tools that, through shared leadership, help an institution achieve clearly stated organisational objectives that aim to create value for all stakeholders.Organizational performance requires a performance management model that establishes a basis for organizational governance and a framework for how managers should make decisions when it comes to creating and distributing value in the organization . A leadiTo that end, performance assessment needs to consider multiple criteria necessary for the organization to find balance. Central to this notion is the quadruple aim  to assesThe tools and practices used for this action research were kaikaku, A3 reports, kaizen, control rooms, status sheets and kata.Kaikaku is a Japanese word that translates as \u201cradical change\u201d and is seen as a process that can generate significant results when existing practices are replaced with new ones . KaikakuThe A3 report is a summary document that conveys information about projects on a single A3-sized sheet (11 \u00d7 17 inches format in North America) on which a problem-solving approach is expressed in a structured way . There iKaizen means a \u201cchange for the better\u201d and thus translates continuous improvement into a problem-solving process . This apControl rooms, or obeya in Japanese, are places where team members can meet to assess current performance in a dynamic way and engage in discussion to support future performance 3044. Con3039The status sheet represents a standardised dialogue between an employee and his or her immediate superior. The sheet helps the employee learn about and better understand the organisation\u2019s operations and prevent potential problems within a trajectory. A status sheet meeting is facilitated by a senior administrator from the management committee based on status sheets from the field.Kata are small, structured practice routines. Learning and then combining these individual practice routines is a way of developing competency in the overall way or pattern of doing something . It is iFigure 1 synthesizes these various tools and how they are linked within the organization.All of these tools use the Plan, Do, Check, Adjust (PDCA) problem-solving cycle popularised by Deming . Figure This study uses action research, which consists of generating scientific knowledge to better understand and change the social reality of individuals . This ty17This action research was carried out between June 2016 and October 2018. More than 350 hours of data collection was performed to create field notes taken from semi-structured interviews, focus groups and participant observation. Semi-structured interviews were conducted at the participants\u2019 workplace with four psychosocial workers, six senior administrators, and five middle managers. Each interview lasted between 60 and 90 minutes and was conducted using a semi-structured interview guide. The questions aimed to ascertain what happened and why it happened (diagnosis) and what could have been done differently (reflection). Saturation was reached once the themes and categories became repetitive or no longer provided new or different information .The data analysis strategies led to a detailed description of the various sources, including a full transcript of the content of all individual interviews from the audio recordings. These strategies related to grounded theory include three main coding steps: open coding, axial coding and selective coding .Three 90-minutes focus groups were also conducted in October 2018 based on the organisation\u2019s hierarchical logic, i.e., strategic, tactical and operational. The focus groups were largely based on the learning history approach . A documAdditionally, over 350 hours of data was recorded in field notes from non-participant observations during different interdisciplinary meetings and during strategic, tactical and operational steering-room activities. The field notes were helpful for recording relevant information throughout the data collection period and were also useful for interpreting observations .The adopted methodology minimized the risks of bias thanks to in-depth knowledge of the study setting and great attention paid to the methodology employed . To asseThe research project was approved by the Research and Ethics Committee of the Universit\u00e9 du Qu\u00e9bec \u00e0 Trois-Rivi\u00e8res (No. CER-18-244-07.01).Table 1 presents a summary of the results. Each phase of the PDCA cycle touches upon the types of intervention used for the tools of the integrated performance management system and the results obtained for the service integration project. However, some phases may have overlapped due to the cyclical process of the research.The results are presented based on the cyclical logic structured by the PDCA and action research methodology. In June 2016, senior managers invited 4 middle managers from the integrated youth teams and 4 senior managers to a kaikaku event and to an initial activity whose goal was to improve coordination between the youth programmes directorate and youth protection directorate. The meeting took place over two days.At the start of the kaikaku, senior managers conveyed a very clear vision as part of a true client-centred strategy :A child will never suffer alone.A child will always be supported in his or her pathway.Do the impossible to avoid putting the development or safety of a child in danger. (Children must receive the full range of services to ensure their development and safety.)Internal partners  and external partners were asked to contribute at a later date. As one staff member explained:\u201cJimmy\u201d is not just young; he has other needs too. He may have impairments and be autistic as well [\u2026].\u201dPrior to the kaikaku, the continuous improvement specialist documented the actual service pathway of a child and the child\u2019s family. The initial service request was for a language impairment detected by a perinatal nurse when the child was 20 months old. The last intervention noted in the child\u2019s record was a report that was under assessment, even though the child was almost 10 years old. First, the continuous improvement specialist documented response times, number of staff members, number of interventions, etc. The Chief Executive Officer (CEO) believes that it would have been useful to invite a child or their parents to participate in the service integration project. Nevertheless, two obstacles quickly became apparent. The first stemmed from the merger of 7 institutions and a new culture of collaboration that had to be created among different partners. The second related to the confidentiality of reported situations and the need to manage the risks of social stigmatization given the territory\u2019s minimal client base .A major concern for the kaikaku participants was simplifying the child\u2019s pathway through services. As youths in difficulty are truly at the heart of the integration project, the managers decided to give the project the name of a child\u2014 \u201cJimmy\u201d\u2014so that everyone saw this child as a real partner. The CEO stated that the kaikaku gave the project momentum:\u201cAfter doing the kaikaku, we made a radical change and stayed focused on our goal.\u201dThe use of the A3 reports on the second day to deploy the integration project helped clarify the performance indicators that could improve service accessibility and continuity for the target clientele and each manager at the session signed it as a formal commitment to carry out and help implement the process. A member of the management team said:\u201cThe A3 reports allowed people who were supposed to contribute to the project to reflect on the project [\u2026.] when the managers signed the collaboration contract at the beginning of the project  that\u2019s when people really became engaged.\u201dFour kaizen workshops required more tactical and operational approaches and the idea was not to establish complete integration for each youth but rather to reflect on a trajectory that could be adjusted based on the profiles of each little \u201cJimmy\u201d in the territory. The performance indicators were tracked in the tactical control room and in the multiple operational control rooms of the integrated teams.Despite the A3 tracking in the strategic control room, the integration project encountered issues that seriously impeded the integration project. Difficulties arising from the leadership of the senior managers of the different youth directorates hindered cooperation between the two sectors involved in the integration project. According to Kodner and Kyriacou , weak in\u201cIn some situations, we are still working in silos. We can\u2019t work on Jimmy\u2019s case on our own; these are young people with service episodes who may be transiently intellectually disabled or experiencing dependency  but all we have to help Jimmy together. The project helps us do that.\u201dThe arrival, in 2018, of two new senior managers with backgrounds in collaborative practices allowed for a single tactical control room to be set up for these two directorates. This was a major innovation. A middle manager had this to say about this innovation:\u201cImplementing the tactical room jointly between the youth program and the youth protection directorate has advantages, such as continuity. The tactical control room mobilized everyone in a new integration context.\u201dThe tactical control room is where the continuum of services required by \u201cJimmy\u201d and any areas of discontinuity identified by the operational control rooms are monitored. The comments of a middle manager support the importance of the tactical control room:\u201cWe have concrete results  we\u2019re taking action and things are happening  there\u2019s follow-up in the other control rooms.\u201dImprovement Kata are an important practice methodology used during activities at operational or visual stations that identify improvement opportunities and next steps based on a PDCA cycle.An example of cooperation and a staff member\u2019s concern for service integration was made through an Improvement Kata in the operational control room. Lack of contact over a long period led to dissatisfaction among foster families who need ongoing support to help a foster child who is coping with personal and family issues. With this approach, the institution can now confirm that all children placed with foster families are met with monthly. \u201cJimmy\u201d no longer suffers alone and is always supported. The target was then set by the integrated youth team.Given the slow progress in the integration project and the lack of results to help Jimmy due to a lack of leadership, in June 2017 the CEO proposed creating a status sheet to better understand and document the trajectory through dialogue between an employee and his or her immediate superior. This new step created an anchor point for a new PDCA cycle. This individual status sheet was added as a complement to the activities in the operational control rooms and aimed to resolve the problems of accessibility, continuity and workplace well-being. Managers received training on the status sheets. Discussions were held to link the status sheets with the goals set out within the strategic A3 reports and the A3 projects. To reinforce this new practice, the CEO relied on the relationship skills of the continuous improvement specialist. The coaching of managers and teams was one reason for Project Jimmy\u2019s success.Within six months, the status sheet helped minimise problems tracking significant indicators meant to improve the targets set at the start of the integration project. This tool opened the door to service integration by getting the other youth directorates involved to alleviate problems related to fragmentation that, in the words of a middle manager, \u201ccould let a Jimmy fall through the cracks.\u201d One manager was impressed by the speed of this tool and said:\u201cFor me, the status sheet was a revelation out of the whole process.\u201dOnce a week, all managers are invited to a conference call with the associate chief executive officer to report on each team\u2019s progress. Called \u201cstatus sheet meetings,\u201d these weekly calls held every Friday between 8:00 a.m. and 9:00 a.m. let staff assess performance in terms of service accessibility and continuity in the trajectory and report on progress made and obstacles encountered since the previous meeting. For example, one question asked at the meeting relates to the number of users who do not show up for their appointments. For each no-show, the staff member is asked to explain why. Another issue relates more to staff well-being: the manager asks the staff member about their perception of their workload, and if the staff member feels overwhelmed, action is taken immediately. Comments from senior manager highlight the potential of this tool of the integrated performance management system:\u201cWithout the status sheet, we would have no links between our control rooms; there would be a piece missing. The status sheet meetings allow staff to see how proactively removing obstacles to operational performance puts \u201cJimmy\u201d at the heart of this approach.\u201dSix months after the status sheet was implemented in complementarity with the control rooms, improvements had been made in relation to targets to enhance service accessibility and continuity. At the start of the integration project, the average time between the assessment and a first intervention was 16.96 days, whereas the ministerial target was 12 days. In November 2017, the average time had decreased to 8.35 days. This significant time reduction helps staff respond more quickly to protect the needs of vulnerable children and prevent their situations from deteriorating. The service intensity, which had been 0.96 interventions per day per worker, improved significantly and rose to 3.6 interventions per day per worker. A 275% improvement over two years indicates improved access to services. Improving service intensity in turn optimizes staff case load and reduces the wait times for families experiencing problems. Clear improvements were also noted in the implementation of intervention plans, for which the ministerial target was 85%, as the results showed an increase in intervention plans from 70% to 85% in a statutory context and from 10% to 43% in a voluntary context. The fact that families can have an intervention plan makes it easier to determine the problem and the best tools to resolve it, which in turn creates better linkage, better coordination, and fuller integration. Finally, the disability insurance rate dropped from 14.30% to 8.70%, which generated substantial savings. When staff return to work, this provides better service continuity for families by ensuring that their services do not become fragmented. In addition to indicator performance, team actions helped fulfill the vision set out during the kaikaku, i.e., that Jimmy will never be alone again.Communication is a major challenge in an organisational integration project . The dep\u201cThere are advantages [\u2026] in our day-to-day reality  as problems crop up [\u2026] and then solutions do too.\u201dThe advantage of using the weekly status sheet to improve \u201cJimmy\u2019s\u201d service trajectory is that it generates quick wins in terms of improved coordination and improved communication at all organisational levels.The goal of this exploratory qualitative study is to explain whether integration is supported by an integrated performance management system, particularly through the deployment of control rooms and the status sheet. At IHSSC, the issue of integration is being addressed through the implementation of a service trajectory that ensures service accessibility and continuity for children, youth and family clients and that improves the well-being of staff to reduce the risk of early attrition.This research supports the idea that the integrated performance management system is a collaborative model for trajectory management and that it can therefore support vertical and horizontal integration 1124. Sig11To improve the use of the strategic control room, it would have been interesting to have visual boards of \u201cJimmy\u2019s\u201d trajectory, with the idea that visual management provides a better understanding of processes, highlights opportunities for improvement, and reduces waste . Visual 7The central component of this integration project has been the implementation of an integrated youth team through strategic, tactical and operational control rooms to offer coordinated services. This action research shows how interdependence was created between the two directorates in particular through the tactical and operational control room thanks to trajectory review meetings that fostered discussions between each directorate\u2019s respective stakeholders and forced them to broaden their knowledge, perspectives and interests. The control rooms and the status sheet became true catalysts for integration. These complementary tools fostered the linkage, coordination and full integration of services for the benefit of children, youth and families. The innovation of deploying a single tactical control room integrating the youth protection directorate and the youth programmes directorate supports better communication and, accordingly, confirms that communication among all stakeholders is a key issue in integration processes .The control rooms and the status sheet reinforced the project proposed by the CEO in 2016 to integrate services for the well-being of the territory\u2019s children, youth and families, which in turn reinforces the idea of complementarity between vertical and horizontal integration 6. For theThe integrated performance management system deployed for the Jimmy project upholds the idea that performance is multidimensional and is contingent on the balanced approach of the quadruple aim model. The various tools resulting from the management model has generated not only financial gains but also gains in the areas of accessibility, continuity and staff engagement. Although lacking at the start of the project, performance measurement saw great progress, as the status sheet consolidated the processes defining the trajectory\u2019s measurable objectives and therefore collected performance data generated by the integration project.Importance of defining the concept of integration during the kaikaku to give the project meaning. The stakeholders of the trajectory must have a better knowledge of an integration continuum.Personalizing the project by naming it \u201cJimmy.\u201d He became the catalyst for the integration project. He participates in the creation of meaning. Each worker who took part in the project had a very clear reference to a \u201cJimmy\u201d in a vulnerable situation in his entourage. The speakers were keen to contribute to Jimmy\u2019s well-being in a more fluid and improved trajectory. There was no fear or resistance to integrating the services.The use of the tools of the integrated performance management system supports the stakeholders on a daily basis. Staff members no longer face the challenges of working with vulnerable clients alone, as they are met with on a weekly basis both through the status sheet and the control room. These tools of the integrated performance management system support active listening and create the conditions for requests to be grouped so that staff can adequately respond to children\u2019s needs through a standardisation of formal communications.The integrated performance management system is first and foremost a collaborative management model supporting the integration and improvement of care and services. The control rooms and the status report demonstrate the proactive action of operational teams in identifying obstacles and solutions to an optimal path to meet customer needs.The creation of a single tactical control room between two complementary departments that supports processes to better coordinate services. Observations from this research suggest that the tactical control room makes any obstacles in the trajectory flow instantly visible to managers. Having staff members participate in the operational control room helps them work together to ensure service access and continuity while drawing from expertise from different areas.Like many institutions in Quebec\u2019s health and social services network, the IHSSC had to improve its performance while tackling the integration challenges posed by the 2015 reform. To face this challenge, the institution decided to deploy an integrated performance management system. Supported by the different tools of the integrated performance management system, the \u201cJimmy\u201d integration project reinforces the implementation of linkage, coordination and full integration models that become strong connections between teams. The status sheet and control room are tools that vertically integrate different hierarchical levels and horizontally integrate various front-line stakeholders through the user-oriented trajectory.Based on this study\u2019s observations, future research avenues could address how an integration project supported by different tools of the integrated performance management system improves employee workplace well-being to ensure accessible and continuous services. Future research could also determine how target indicators change over a longer period and explore the optimal conditions to ensure the organisational sustainability of this type of integration project for different clienteles. Overall, it would be useful to look at the principles of the \u201clearning organization\u201d as part of an organizational transformation that fosters service integration processes. Useful outcomes could also come about through a convergence of the integrated performance management system with organizational capacity to improve results in a context in which practice innovation is encouraged."]}
{"representative": "Performance management systems have been introduced in health and social services institutions to improve organizational performance, supporting the emergence of new management behaviors that are more rooted in collaborative management practices. This study aims to understand how different leadership styles emerge through the implementation of a performance management system and its related tools, and how these can foster distributed leadership.Over two years, the implementation of an integrated performance management system supporting the integration of social services for children, youth, and families was studied at a recently merged Canadian healthcare organization. Qualitative analysis of data collected from 15 interviews, 3 focus groups, and over 350\u2009h of non-participant observation was conducted.The results show that leadership evolved to adapt to the context of organizational integration and was no longer confined to a single manager. Transformational leadership was needed to encourage the emergence of a new integrated performance management system and new behaviors among middle managers and team members. Transactional leadership was legitimized through the use of a status sheet when the integration project did not deliver the expected results. Both transformational and transactional leadership paved the way to distributed leadership, which in turn promoted collaborative practices associated with activities in control rooms and dialogue stemming from the status sheets. Distributed leadership among team members made a difference in the outcome of the integration project, which became a driver of collaboration.The integrated performance management system and the use of its tools can help renew leadership in health and social service organizations. The results lend credence to the importance of distributed leadership in promoting collaborative practices to improve services for children, youth, and families. The results also highlight how various leadership styles can contribute to the emergence of distributed leadership over time. In recent decades, health and social service organizations have attempted to implement various initiatives to improve performance , particuA condition for successful service integration is collaboration, which is often presented as a tool to find new solutions to the complex problems of the fragmentation of care and services  and to rOn April 1, 2015, the province of Quebec, Canada, restructured its health and social services network by reducing its number of institutions from 182 to 34. These new institutions now group the facilities and services for the population of its region. The initial goal of the reform was to reduce bureaucracy by flattening organizational structures from three to two levels and centralizing powers with the Minister of health and social services. This flattening of the management hierarchy resulted in the elimination of 1300 managerial positions.The transformation of the health and social services network is supported by the deployment of a new performance management system that encourages stakeholders to reflect on the evolving role of managers. An IPMS encourages traditional models, in which leadership resides in a single individual, to evolve into leadership development efforts that extend to all levels of the organization. Transformational leadership and transactional leadership are powerful concepts for improving organizational performance , 18. HowThis paper studies how different leadership styles evolve during the deployment of an IPMS. Through a longitudinal case study, it aims to demonstrate how the adaptation of different leadership styles in conjunction with IPMS tools can support the integration of social services for children, youth, and families. The following section draws from a literature review to summarize the main leadership typologies and presents the integrated performance management system and the various tools used by the organization. This is followed by a presentation of the organizational context and the research methodology. The results reveal a multi-dimensional experience of how leadership styles evolved over more than two years. The paper concludes with a discussion of the results, the implications, and future avenues of research.Over the last forty years, the literature on leadership has evolved from the \u201cGreat Person Theory\u201d into how leaders behave and develop relationships with followers . AccordiLaissez-faire leadership is a passive form of leadership, where leaders provide little to no feedback which can often leave employees in the dark. This is usually detrimental to employee engagement. This type of leader is nowhere to be seen when problems arise and is not very engaged with his or her employees. These leaders seek a hands-off approach to management .Transactional leaders focus on the resources they manage. They also employ management by exception either in an active way (trying to prevent problems) or a passive way (only intervening when a problem occurs) . Transac and care  about each employee, who can articulate a vision that inspires employees, and foster the acceptance of group goals  when the managers signed the collaboration contract at the beginning of the project  that\u2019s when people really became engaged.\u201dTo reinforce collaboration between directors and middle managers, a strategic A3From the strategic A3 report, four other A3 projects were developed using rapid improvement events and were named Charlotte, Henriette, Rosalie, and Juliette. These activities required more tactical and operational approaches, and the goal was to develop an action plan to help integrate services in the desired trajectory. To monitor these A3s, operational control rooms were quickly deployed in the integrated youth teams, where employees, directors, and middle managers were brought together every week to set targets for the service integration project.\u201cDuring the summer  I had a team member take over to get us to the point that the room was part of our team [\u2026] and all employees had taken ownership of it.\u201dThis reality was further unpacked by the following statement from a staff member:\u201cSince we became an integrated team, it has been much easier for us to work together and in proximity to each other. It\u2019s been really positive.\u201dThe operational control rooms of the new integrated youth teams provided part of the foundation for the emergence of distributed leadership, by democratizing management activities, i.e. team members take turns leading the activity, and this task is no longer under the purview of the manager. As one middle manager explained about the team\u2019s ownership and accountability:\u201cWe dramatically reduced the wait time between assessment and the start of case management.\u201dFrom the start of activities in the operational control rooms, the participants submitted many improvement initiatives , which dInitial staff engagement in the integration project appeared good, especially following efforts made to urgently remove daily irritants that had persisted for many years. However, once these irritants had been dealt with, improvement initiatives became increasingly rare or addressed routine issues, such as poorly soundproofed consultation rooms. One middle manager said, \u201cThese are minor annoyances.\u201d After one year, no improvements had been made on the key performance indicators, which indicated that problem-solving to find solutions to trajectory-related challenges was unfortunately not taking place.\u201cI think there are challenges in making the numbers reflect the living reality of the service offer.\u201dThe project encountered major difficulties during the first year not so much due to the project managers\u2019 commitment and belief in the project\u2019s rationale but because of how performance indicators were monitored. According to one middle manager, performance measurement was one of the main reasons for low levels of engagement from staff, who felt that quantitative evaluation did not properly represent the fundamentally human dimension of their jobs:\u201cTake away the statistics, performance, and everything. They are completely useless. It just puts pressure on staff.\u201dObservations from the research showed a laissez-faire leadership style on the part of some directors who experienced difficulties engaging their teams in measuring indicators. Comments from one staff member speak to this problem:The action plans for the A3 projects, therefore, remained conceptual and were not conducive to quick action. An informal status quo bogged down the project in a kind of non-performance, and the service trajectory was not monitored at all. At this point, it was observed that some leaders with formal power over the team were negatively influencing the project.\u201cThe meeting was key for the project. It gave a glimmer of hope [for us to] work more as a team. We had to look at what wasn\u2019t working.\u201dAfter observing the directors\u2019 laissez-faire style, the CEO and her associate (COO) organized a project review day in June of the following year. They started the meeting by sharing their disappointments and communicating their reservations about any real progress having been made with the service integration project with the various middle managers involved since the project started in June 2017. The integration project was not bearing the expected fruits. The directors and middle managers found it difficult to be confronted and questioned about why collaborative spaces were being hindered. However, as one middle manager expressed:Aware that the philosophy of the IPMS reinforces a bottom-up approach to problem-solving to help staff identify problems and find the right solutions, the CEO set up a status sheet so that everyone could become better aware of the trajectory and could more effectively document it. Every week, using the status sheet, a performance review was conducted by monitoring the effectiveness of the interfaces of the trajectory through accessibility and continuity indicators. This action by the CEO embodied a more directive transactional leadership approach aimed at getting the project back on track. At first, middle managers were reluctant to adopt this practice with their teams because they felt obligated to apply top-down decisions. However, it proved to be a turning point toward the success of the integration project. As one middle manager explained:\u201cI feel like the status sheet is what changed things.\u201dThe inevitable centralization of leadership toward the executives led to a genuine renewal in the deployment of the IPMS so that the trajectory targets could be achieved. Furthermore, the difficulties encountered during the first year of the integration project and the subsequent changes implemented by the CEO contributed to the departure of two key opinion leaders (directors) who did not agree with the organizational priorities expressed by the executives.Status sheet sessions were held weekly during a Friday morning conference call attended by all middle managers. The observations suggest that transactional leadership was an excellent vehicle for leading the status sheet, as this tool is task and results-oriented. The sessions began with a review of indicators related to accessibility, continuity, and quality so that everyone could quickly detect any deviations from the standard. Leaders could focus on generating possible solutions from an employee in order to have corrective action taken. However, the leader (director) could also help collaboration emerge during the second part of the status sheet, which focused on qualitative aspects, particularly the perceptions of the team climate, risk management, and comments received by users.\u201cThe other thing I really like is how good performance is recognized. This is very positive because we never used to take the time to do this every week. It happened maybe once or twice a year. We definitely point it out and we have peers recognize each other. Peer recognition increases team spirit.\u201dWithout calling it a recognition program as such, team members\u2019 positive performance was highlighted by their peers every week both during the control room activities and during the status sheet sessions. The purpose of this recognition was to improve the working climate so that each team member felt valued, which was appreciated by both middle managers and employees:After six months of using the status sheet in conjunction with the control rooms, significant improvements to accessibility and continuity had been achieved. Initially, the average wait time in child protection was 16.96\u2009days, compared to the government target of 12\u2009days. The achieved result was 8.35\u2009days. Service intensity at the start of the project was 0.96 interventions per day per worker and improved to 3.6 interventions per day per worker. Significant gains were also achieved regarding the implementation of intervention plans, which rose from 70% to the government target of 85% and from 10 to 43% in statutory and voluntary contexts respectively. Furthermore, the disability insurance rate decreased to 8.70% from its initial level of 14.30%. The target was 6.03% at the time.\u201cWe\u2019ve got a director of youth protection and a director of youth programs working side by side, and that\u2019s a big win.\u201dAs mentioned previously, two directors left and were replaced during the first year of the integration project. This change in top management for the youth programs led to a new dynamic that supported greater interprofessional collaboration, particularly in the control room. After this change, leadership started to be distributed based on trust and based on the managers\u2019 mutual knowledge of each other. As one middle manager pointed out:\u201cYou have to be completely in sync. Since the fall, we haven\u2019t felt that the two departments were working as well together, [nor did we have anything] facilitating a strong feeling of cohesion in our control room.\u201dWhen the new directors arrived, they began sharing leadership and moved toward better collaboration that left no room for interdepartmental competition, which confirms that service integration is more dependent on human factors and added value for the client experience rather than on organizational and structural issues . The twoThe two new directors supported the clear and integrated vision of Jimmy\u2019s trajectory articulated by the CEO and upheld the need for measurement to achieve the performance targets. Meetings in the tactical control room provided opportunities for both departments together to evaluate team performance by sharing essential information to raise important issues about Jimmy\u2019s trajectory and devise collective solutions through consensus, thus supporting Barnas\u2019 view  that the\u201cImplementing the tactical room jointly between the youth program and the youth protection directorate has advantages, such as continuity  there are projects that, even though they are more the responsibility of the other department, considering that I am involved, I take responsibility for them.\u201dGiven that no formal activities were held in the tactical control room during the first year of the project\u2019s deployment, the new directors had to take ownership of how the tactical control room functioned. The decision that the two departments with the same clientele should share the same control room led to a change in leadership and gave the teams the legitimacy to commit to the service integration project. The goals that the directors shared with the teams to help everyone understand the reasoning behind the changes created a climate of mutual trust, which was a key factor that allowed distributed leadership to emerge after two years of experimentation. Democratizing control room activities also fostered the emergence of distributed leadership. Both directors made this a collective responsibility. Other departments were also involved in Project Jimmy. Managers or staff were invited to attend control room activities to find collective solutions to the problems of accessibility, continuity, and quality throughout Jimmy\u2019s trajectory. Distributed leadership made it possible to develop a culture of integration between the first and second service lines. For example, as a director pointed out:Distributed leadership is considered an effective way to foster team performance in complex situations, such as those found in programs for children and youth in difficulty. This paper tracks the evolution of the different leadership styles adopted during the implementation of a new management model Fig.\u00a0. The resAt the onset of the integration project, the CEO exhibited transformational leadership by articulating a clear vision, by challenging directors and managers to actively participate in the integration project, and by fostering their participation by signing the Jimmy A3. Transformational leadership exhibited by top administrators is frequently cited as behavior that allows institutions to evolve through continuous improvement . The traThe matrix organizational structure implemented because of the new reform seemed to have negatively impacted the development of collaboration, as the leader with formal power had a purview that was too broad. This partially explains why distributed leadership at the strategic level still had not fully emerged by the end of our study.This case study demonstrates that transformational leadership from executives did not initially influence the type of leadership adopted at the tactical level, as highlighted by the dotted arrows in Fig. Laissez-faire leadership led to the emergence of transactional leadership from the CEO, through the implementation of the status sheet, as a response to address the absence of progress made in the project. This course of action is typically more conducive in crises . TransacThe executives used the reform as an opportunity to create territorial teams dedicated to children, youth, and families. The pooling of professional and multidisciplinary expertise and the initial familiarity of members contributed to the emergence of distributed leadership. From the start of the project and the set-up of the control rooms, each member\u2019s contribution to providing accessible services was an important mechanism for achieving the required interdependence to develop distributed leadership . Our obsDespite good proximity, a certain degree of familiarity, and high task complexity, our findings show that the teams still seemed to wait for a leader to provide solutions to their problems. The control room lets staff identify problems and propose appropriate solutions. The control rooms, particularly the operational control rooms, therefore became more like information rooms. According to Pearce and Sims , the basThe implementation of an IPMS can support a new way of managing organizations where leadership and decision-making are shared in teams at all levels of the organization. Notwithstanding this willingness to share and adopt distributed leadership through collaborative practices, a more traditional top-down management style is a fundamental source of decision-making for organizations to run smoothly.In the end, some leadership responsibilities have been retained by the department head while other responsibilities are now distributed among the integrated team through the control rooms and status sheet. Distributed leadership is more in keeping with collaborative profiles or competencies that are strongly ingrained in individuals. The complementarity between transformational leadership and distributed leadership at all hierarchical levels is a promising avenue to reinforce the organization\u2019s capacity to change. The more that this leadership combination evolves, the more the organizational capacity to change will improve as new top and middle managers with a collaborative style arrive and real improvements are made in terms of care and service accessibility, and continuity.recognizing individuals). Through transformational leadership, she asked top and middle managers to contribute to this project, based on their knowledge and expertise in the field of services for children. This would ultimately legitimize the emergence of distributed leadership further down the line, even though the short-term effects were not conclusive.Overall, this case study shows that a service integration project does not need to be guided by a single leadership style but rather by distributed leadership that emerges over time. This study also highlights the interdependence of leadership styles, where one is usually the result of another. While distributed leadership did not emerge quickly, its foundations were laid at the onset of the integration project. The CEO recognized the complexity of the project to integrate psychosocial services and that she needed to work with people who had skills and expertise that were complementary to her own  in the deployment of an IPMS. This study was carried out in the child, youth, and family social services sector, where different hierarchical levels, i.e. both managers and staff, were required to adopt new behaviors so that distributed leadership could emerge. This qualitative study makes a useful contribution regarding the complementarity of the foundations of distributed leadership, the tools of the IPMS, and integration processes applied over time.This case study raises questions about its transferability, along with certain limitations. The scope of this study was limited to the youth sector. A comparison with other sectors could be useful. Future research could be done in similar contexts  to explore the conditions and barriers for success, and for organizations to learn collective lessons to improve the performance of health and social services networks. Our results also show that recognition of team performance may have helped trigger the emergence of shared leadership. Hence, future research could explore this phenomenon through a positive psychological lens , to stud", "texts": ["Performance management systems have been introduced in health and social services institutions to improve organizational performance, supporting the emergence of new management behaviors that are more rooted in collaborative management practices. This study aims to understand how different leadership styles emerge through the implementation of a performance management system and its related tools, and how these can foster distributed leadership.Over two years, the implementation of an integrated performance management system supporting the integration of social services for children, youth, and families was studied at a recently merged Canadian healthcare organization. Qualitative analysis of data collected from 15 interviews, 3 focus groups, and over 350\u2009h of non-participant observation was conducted.The results show that leadership evolved to adapt to the context of organizational integration and was no longer confined to a single manager. Transformational leadership was needed to encourage the emergence of a new integrated performance management system and new behaviors among middle managers and team members. Transactional leadership was legitimized through the use of a status sheet when the integration project did not deliver the expected results. Both transformational and transactional leadership paved the way to distributed leadership, which in turn promoted collaborative practices associated with activities in control rooms and dialogue stemming from the status sheets. Distributed leadership among team members made a difference in the outcome of the integration project, which became a driver of collaboration.The integrated performance management system and the use of its tools can help renew leadership in health and social service organizations. The results lend credence to the importance of distributed leadership in promoting collaborative practices to improve services for children, youth, and families. The results also highlight how various leadership styles can contribute to the emergence of distributed leadership over time. In recent decades, health and social service organizations have attempted to implement various initiatives to improve performance , particuA condition for successful service integration is collaboration, which is often presented as a tool to find new solutions to the complex problems of the fragmentation of care and services  and to rOn April 1, 2015, the province of Quebec, Canada, restructured its health and social services network by reducing its number of institutions from 182 to 34. These new institutions now group the facilities and services for the population of its region. The initial goal of the reform was to reduce bureaucracy by flattening organizational structures from three to two levels and centralizing powers with the Minister of health and social services. This flattening of the management hierarchy resulted in the elimination of 1300 managerial positions.The transformation of the health and social services network is supported by the deployment of a new performance management system that encourages stakeholders to reflect on the evolving role of managers. An IPMS encourages traditional models, in which leadership resides in a single individual, to evolve into leadership development efforts that extend to all levels of the organization. Transformational leadership and transactional leadership are powerful concepts for improving organizational performance , 18. HowThis paper studies how different leadership styles evolve during the deployment of an IPMS. Through a longitudinal case study, it aims to demonstrate how the adaptation of different leadership styles in conjunction with IPMS tools can support the integration of social services for children, youth, and families. The following section draws from a literature review to summarize the main leadership typologies and presents the integrated performance management system and the various tools used by the organization. This is followed by a presentation of the organizational context and the research methodology. The results reveal a multi-dimensional experience of how leadership styles evolved over more than two years. The paper concludes with a discussion of the results, the implications, and future avenues of research.Over the last forty years, the literature on leadership has evolved from the \u201cGreat Person Theory\u201d into how leaders behave and develop relationships with followers . AccordiLaissez-faire leadership is a passive form of leadership, where leaders provide little to no feedback which can often leave employees in the dark. This is usually detrimental to employee engagement. This type of leader is nowhere to be seen when problems arise and is not very engaged with his or her employees. These leaders seek a hands-off approach to management .Transactional leaders focus on the resources they manage. They also employ management by exception either in an active way (trying to prevent problems) or a passive way (only intervening when a problem occurs) . Transac and care  about each employee, who can articulate a vision that inspires employees, and foster the acceptance of group goals  when the managers signed the collaboration contract at the beginning of the project  that\u2019s when people really became engaged.\u201dTo reinforce collaboration between directors and middle managers, a strategic A3From the strategic A3 report, four other A3 projects were developed using rapid improvement events and were named Charlotte, Henriette, Rosalie, and Juliette. These activities required more tactical and operational approaches, and the goal was to develop an action plan to help integrate services in the desired trajectory. To monitor these A3s, operational control rooms were quickly deployed in the integrated youth teams, where employees, directors, and middle managers were brought together every week to set targets for the service integration project.\u201cDuring the summer  I had a team member take over to get us to the point that the room was part of our team [\u2026] and all employees had taken ownership of it.\u201dThis reality was further unpacked by the following statement from a staff member:\u201cSince we became an integrated team, it has been much easier for us to work together and in proximity to each other. It\u2019s been really positive.\u201dThe operational control rooms of the new integrated youth teams provided part of the foundation for the emergence of distributed leadership, by democratizing management activities, i.e. team members take turns leading the activity, and this task is no longer under the purview of the manager. As one middle manager explained about the team\u2019s ownership and accountability:\u201cWe dramatically reduced the wait time between assessment and the start of case management.\u201dFrom the start of activities in the operational control rooms, the participants submitted many improvement initiatives , which dInitial staff engagement in the integration project appeared good, especially following efforts made to urgently remove daily irritants that had persisted for many years. However, once these irritants had been dealt with, improvement initiatives became increasingly rare or addressed routine issues, such as poorly soundproofed consultation rooms. One middle manager said, \u201cThese are minor annoyances.\u201d After one year, no improvements had been made on the key performance indicators, which indicated that problem-solving to find solutions to trajectory-related challenges was unfortunately not taking place.\u201cI think there are challenges in making the numbers reflect the living reality of the service offer.\u201dThe project encountered major difficulties during the first year not so much due to the project managers\u2019 commitment and belief in the project\u2019s rationale but because of how performance indicators were monitored. According to one middle manager, performance measurement was one of the main reasons for low levels of engagement from staff, who felt that quantitative evaluation did not properly represent the fundamentally human dimension of their jobs:\u201cTake away the statistics, performance, and everything. They are completely useless. It just puts pressure on staff.\u201dObservations from the research showed a laissez-faire leadership style on the part of some directors who experienced difficulties engaging their teams in measuring indicators. Comments from one staff member speak to this problem:The action plans for the A3 projects, therefore, remained conceptual and were not conducive to quick action. An informal status quo bogged down the project in a kind of non-performance, and the service trajectory was not monitored at all. At this point, it was observed that some leaders with formal power over the team were negatively influencing the project.\u201cThe meeting was key for the project. It gave a glimmer of hope [for us to] work more as a team. We had to look at what wasn\u2019t working.\u201dAfter observing the directors\u2019 laissez-faire style, the CEO and her associate (COO) organized a project review day in June of the following year. They started the meeting by sharing their disappointments and communicating their reservations about any real progress having been made with the service integration project with the various middle managers involved since the project started in June 2017. The integration project was not bearing the expected fruits. The directors and middle managers found it difficult to be confronted and questioned about why collaborative spaces were being hindered. However, as one middle manager expressed:Aware that the philosophy of the IPMS reinforces a bottom-up approach to problem-solving to help staff identify problems and find the right solutions, the CEO set up a status sheet so that everyone could become better aware of the trajectory and could more effectively document it. Every week, using the status sheet, a performance review was conducted by monitoring the effectiveness of the interfaces of the trajectory through accessibility and continuity indicators. This action by the CEO embodied a more directive transactional leadership approach aimed at getting the project back on track. At first, middle managers were reluctant to adopt this practice with their teams because they felt obligated to apply top-down decisions. However, it proved to be a turning point toward the success of the integration project. As one middle manager explained:\u201cI feel like the status sheet is what changed things.\u201dThe inevitable centralization of leadership toward the executives led to a genuine renewal in the deployment of the IPMS so that the trajectory targets could be achieved. Furthermore, the difficulties encountered during the first year of the integration project and the subsequent changes implemented by the CEO contributed to the departure of two key opinion leaders (directors) who did not agree with the organizational priorities expressed by the executives.Status sheet sessions were held weekly during a Friday morning conference call attended by all middle managers. The observations suggest that transactional leadership was an excellent vehicle for leading the status sheet, as this tool is task and results-oriented. The sessions began with a review of indicators related to accessibility, continuity, and quality so that everyone could quickly detect any deviations from the standard. Leaders could focus on generating possible solutions from an employee in order to have corrective action taken. However, the leader (director) could also help collaboration emerge during the second part of the status sheet, which focused on qualitative aspects, particularly the perceptions of the team climate, risk management, and comments received by users.\u201cThe other thing I really like is how good performance is recognized. This is very positive because we never used to take the time to do this every week. It happened maybe once or twice a year. We definitely point it out and we have peers recognize each other. Peer recognition increases team spirit.\u201dWithout calling it a recognition program as such, team members\u2019 positive performance was highlighted by their peers every week both during the control room activities and during the status sheet sessions. The purpose of this recognition was to improve the working climate so that each team member felt valued, which was appreciated by both middle managers and employees:After six months of using the status sheet in conjunction with the control rooms, significant improvements to accessibility and continuity had been achieved. Initially, the average wait time in child protection was 16.96\u2009days, compared to the government target of 12\u2009days. The achieved result was 8.35\u2009days. Service intensity at the start of the project was 0.96 interventions per day per worker and improved to 3.6 interventions per day per worker. Significant gains were also achieved regarding the implementation of intervention plans, which rose from 70% to the government target of 85% and from 10 to 43% in statutory and voluntary contexts respectively. Furthermore, the disability insurance rate decreased to 8.70% from its initial level of 14.30%. The target was 6.03% at the time.\u201cWe\u2019ve got a director of youth protection and a director of youth programs working side by side, and that\u2019s a big win.\u201dAs mentioned previously, two directors left and were replaced during the first year of the integration project. This change in top management for the youth programs led to a new dynamic that supported greater interprofessional collaboration, particularly in the control room. After this change, leadership started to be distributed based on trust and based on the managers\u2019 mutual knowledge of each other. As one middle manager pointed out:\u201cYou have to be completely in sync. Since the fall, we haven\u2019t felt that the two departments were working as well together, [nor did we have anything] facilitating a strong feeling of cohesion in our control room.\u201dWhen the new directors arrived, they began sharing leadership and moved toward better collaboration that left no room for interdepartmental competition, which confirms that service integration is more dependent on human factors and added value for the client experience rather than on organizational and structural issues . The twoThe two new directors supported the clear and integrated vision of Jimmy\u2019s trajectory articulated by the CEO and upheld the need for measurement to achieve the performance targets. Meetings in the tactical control room provided opportunities for both departments together to evaluate team performance by sharing essential information to raise important issues about Jimmy\u2019s trajectory and devise collective solutions through consensus, thus supporting Barnas\u2019 view  that the\u201cImplementing the tactical room jointly between the youth program and the youth protection directorate has advantages, such as continuity  there are projects that, even though they are more the responsibility of the other department, considering that I am involved, I take responsibility for them.\u201dGiven that no formal activities were held in the tactical control room during the first year of the project\u2019s deployment, the new directors had to take ownership of how the tactical control room functioned. The decision that the two departments with the same clientele should share the same control room led to a change in leadership and gave the teams the legitimacy to commit to the service integration project. The goals that the directors shared with the teams to help everyone understand the reasoning behind the changes created a climate of mutual trust, which was a key factor that allowed distributed leadership to emerge after two years of experimentation. Democratizing control room activities also fostered the emergence of distributed leadership. Both directors made this a collective responsibility. Other departments were also involved in Project Jimmy. Managers or staff were invited to attend control room activities to find collective solutions to the problems of accessibility, continuity, and quality throughout Jimmy\u2019s trajectory. Distributed leadership made it possible to develop a culture of integration between the first and second service lines. For example, as a director pointed out:Distributed leadership is considered an effective way to foster team performance in complex situations, such as those found in programs for children and youth in difficulty. This paper tracks the evolution of the different leadership styles adopted during the implementation of a new management model Fig.\u00a0. The resAt the onset of the integration project, the CEO exhibited transformational leadership by articulating a clear vision, by challenging directors and managers to actively participate in the integration project, and by fostering their participation by signing the Jimmy A3. Transformational leadership exhibited by top administrators is frequently cited as behavior that allows institutions to evolve through continuous improvement . The traThe matrix organizational structure implemented because of the new reform seemed to have negatively impacted the development of collaboration, as the leader with formal power had a purview that was too broad. This partially explains why distributed leadership at the strategic level still had not fully emerged by the end of our study.This case study demonstrates that transformational leadership from executives did not initially influence the type of leadership adopted at the tactical level, as highlighted by the dotted arrows in Fig. Laissez-faire leadership led to the emergence of transactional leadership from the CEO, through the implementation of the status sheet, as a response to address the absence of progress made in the project. This course of action is typically more conducive in crises . TransacThe executives used the reform as an opportunity to create territorial teams dedicated to children, youth, and families. The pooling of professional and multidisciplinary expertise and the initial familiarity of members contributed to the emergence of distributed leadership. From the start of the project and the set-up of the control rooms, each member\u2019s contribution to providing accessible services was an important mechanism for achieving the required interdependence to develop distributed leadership . Our obsDespite good proximity, a certain degree of familiarity, and high task complexity, our findings show that the teams still seemed to wait for a leader to provide solutions to their problems. The control room lets staff identify problems and propose appropriate solutions. The control rooms, particularly the operational control rooms, therefore became more like information rooms. According to Pearce and Sims , the basThe implementation of an IPMS can support a new way of managing organizations where leadership and decision-making are shared in teams at all levels of the organization. Notwithstanding this willingness to share and adopt distributed leadership through collaborative practices, a more traditional top-down management style is a fundamental source of decision-making for organizations to run smoothly.In the end, some leadership responsibilities have been retained by the department head while other responsibilities are now distributed among the integrated team through the control rooms and status sheet. Distributed leadership is more in keeping with collaborative profiles or competencies that are strongly ingrained in individuals. The complementarity between transformational leadership and distributed leadership at all hierarchical levels is a promising avenue to reinforce the organization\u2019s capacity to change. The more that this leadership combination evolves, the more the organizational capacity to change will improve as new top and middle managers with a collaborative style arrive and real improvements are made in terms of care and service accessibility, and continuity.recognizing individuals). Through transformational leadership, she asked top and middle managers to contribute to this project, based on their knowledge and expertise in the field of services for children. This would ultimately legitimize the emergence of distributed leadership further down the line, even though the short-term effects were not conclusive.Overall, this case study shows that a service integration project does not need to be guided by a single leadership style but rather by distributed leadership that emerges over time. This study also highlights the interdependence of leadership styles, where one is usually the result of another. While distributed leadership did not emerge quickly, its foundations were laid at the onset of the integration project. The CEO recognized the complexity of the project to integrate psychosocial services and that she needed to work with people who had skills and expertise that were complementary to her own  in the deployment of an IPMS. This study was carried out in the child, youth, and family social services sector, where different hierarchical levels, i.e. both managers and staff, were required to adopt new behaviors so that distributed leadership could emerge. This qualitative study makes a useful contribution regarding the complementarity of the foundations of distributed leadership, the tools of the IPMS, and integration processes applied over time.This case study raises questions about its transferability, along with certain limitations. The scope of this study was limited to the youth sector. A comparison with other sectors could be useful. Future research could be done in similar contexts  to explore the conditions and barriers for success, and for organizations to learn collective lessons to improve the performance of health and social services networks. Our results also show that recognition of team performance may have helped trigger the emergence of shared leadership. Hence, future research could explore this phenomenon through a positive psychological lens , to stud"]}
{"representative": "In this work, we did our best to develop a novel and interesting analytical method based on coupling of spectrofluorimetry with first-order multivariate calibration techniques for simultaneous determination of lead (Pd), zinc (Zn) and cadmium (Cd) in HeLa cells. To achieve this goal, quenching of the emission of graphene (GR) was individually investigated in the presence of Pb, Zn and Cd and then, according to the linear ranges obtained from individual calibration graphs, a multivariate calibration model was developed based on modeling of the quenching of the emission of GR in the presence of the mixtures of Pb, Zn and Cd. First-order multivariate calibration models were constructed by partial least squares (PLS), principal component regression (PCR), orthogonal signal correction-PLS (OSC-PLS), continuum power regression (CPR), robust continuum regression (RCR) and partial robust M-regression (PRM) and their performances were evaluated and statistically compared. Finally, the OSC-PLS was chosen as the best model with the best practical performance for analytical purposes.  \u2022The GR was uptaken by the HeLa cells and then, the cells uptook Pb, Cd and Zn.\u2022Individual and multivariate calibration models were developed by the use of several first-order algorithms.\u2022Comparing the performance of the models was performed and the OSC-PLS showed the best performance.\u2022Performance of the OSC-PLS was compared with a reference method.\u2022Our records showed that the OSC-PLS had a comparable performance with the reference method. Sometimes, the heavy metals are considered as contaminants which can be hazardous for human health therefore, monitoring of them is important. Lead (Pb) and cadmium (Cd) are heavy metals which are widely and naturally distributed toxic metals. There are some reports on determination of these metals with zinc (Zn) HeLa is an immortal cell line which is the most commonly used human cell line in scientific research. The HeLa cell line is durable and prolific which make it to be extremely suitable for scientific research. Therefore in this study, we have used the HeLa cells as a very interesting case for developing a novel analytical method for simultaneous determination of the Pb, Cd and Zn.Chemometrics combines chemical data with mathematical and statistical methods to extract useful information which can help the chemists to better justify their observations. Chemometricians have performed different projects by the use of instrumental data 22.13)2 were purchased from Sigma. Commercial Pb, Cd and Zn standards (1\u2009g\u2009l\u22121) were prepared from Merck. Graphene quantum dots (blue luminescent) were purchased from Sigma-Aldrich. The other chemicals which were needed for doing this project were available in archive of our laboratory which had been purchased from Sigma or Merck. Doubly distilled water was used wherever water was needed. A phosphate buffer solution  was prepared from Na2HPO4 and its pH was adjusted at 7.4 by the use of H3PO4 and NaOH.Trypsin-EDTA, Dulbecco\u2019s modified Eagle\u2019s medium (DMEM/F-12 (1:1)), fetal bovine serum , penicillin-streptomycin (PEN-STREP), zinc nitrate hexahydrate, cadmium nitrate tetrahydrate and Pb(NO2.2Spectrofluorimetric data were recorded by a Cary Varian spectrofluorimeter equipped with a quartz cell (1\u2009cm length path). First-order multivariate calibration algorithms including PLS, PCR, OSC-PLS, CPR, RCR, PRM, smoothing of the data and elliptical joint confidence region (EJCR) were run in MATLAB (Version 7.5) by the use of a series of m-files. The first-order multivariate calibration algorithms have been run in MATLAB with the help of PLS-toolbox or TOMCAT. The HeLa cells were prepared from the cell bonk of Kermanshah University of Medical Sciences. Then, the flask was transferred into a culture room where a deep-freezer (\u221280\u2009\u00b0C), a memmert incubator, a JTLV CZS hood and a Motic microscope were existed for cell culturing. pH adjustments were performed by a Jenway pH meter 3510. Performance of the developed methodology was compared with the results of an Agilent atomic absorption spectrometer as reference method (AAS). Operating conditions for the AAS were: PMT voltage (450\u2009V), slit width (0.40\u2009nm), lamp current (9.0\u2009mA), sample volume (20\u2009\u00b5l), purging gas (argon), sample injection replicates (2) and measurement (peak height). All the calculations which were needed for data processing were performed on a Dell XPS laptop.2.32 +95% air) at 37\u2009\u00b0C during a day (24\u2009h). For uptaking the GR, 100\u2009ng\u2009mL\u22121 GR was added to different culture dishes and incubated at different times and then, the cells were washed with PBS  and left to be in the PBS.Dispersion of the HeLa cells were performed in DMEM +\u2009FBS (10%) +\u2009PEN-STREP (1%) and seeded on five confocal dishes and then, they were incubated at an humidified atmosphere  were added to the dishes. The cells were further incubated for 2\u2009h and washed with the PBS for three times and kept in the PBS. Spectrofluorimetric monitoring of the Pb, Cd and Zn was performed by excitation at 405\u2009nm. For performing background correction on the data, the control cells which had not been incubated with GR (didn\u2019t have any GR) was prepared. The procedures described above were continued by digestion of the treated and control cells with trypsin and then, the cells were kept in the PBS. Afterwards, the cells were counted, broken by ultrasonic and centrifuged. Finally, the supernatant of cells were measured spectrofluorimetrically.For simultaneous determination of Pb, Cd and Zn in HeLa cells, the seeded cells were allowed to grow during a day (24\u2009h) and 1\u2009mL DMEM having 1300\u2009ng\u2009mL2.4In this work, we are going to develop a novel spectrofluorimetric method assisted by chemometric methods which will enable us to simultaneous determine Pb, Cd and Zn in living cells. Data treatment and development of multivariate calibration models must be very carefully performed to achieve the final goal. Prior to data modeling, all the spectrofluorimetric data were treated according to the following equation RMSEP: root mean square error of prediction and REP: relative error of prediction):yact and ypred are nominal and predicted concentrations, respectively, and ymean is the mean of the nominal concentrations. n are the number of samples in the validation set. Precision and accuracy of the developed calibration models will be compared according to the ellipses of the EJCR as well. Univariate calibrations and multivariate calibration and validation sets were performed in internal medium of the cells and by digestion of the cells with trypsin, the medium was extracted. This is a very important advantage which causes having a same medium for calibration and validation of the method which can help us for exploiting first-order advantage.All the data used in this work after passing this correction step was used for the next steps. Emission of the control cells was subtracted from the emission of the all of the cells and the corrected emissions were used for developing multivariate calibration models. Background correction was performed on the whole of data by subtracting emission of the control cells from emission of the whole of sets. Performance of the calibration models will be compared by the use of the following equations  and PRM: number of LVs\u2009=\u20093 and PDC\u2009=\u20090.12. After application of the algorithms and optimization of their parameters and constructing multivariate calibration models, their performance was verified by their application to a validation set having cells with different concentrations of Pb, Cd and Zn whose composition is shown by In order to multivariate calibrate the emission of the GR with concentration of Pb, Cd and Zn, a central composite design was developed based on linear ranges obtained from individual calibration graphs. Composition of the calibration set is shown in In order to further verification of the performance of the spectrofluorimetric method assisted by OSC-PLS, the AAS was applied to the prediction of the concentrations of the validation set as reference method and the results are shown in RSD) for the analysis of 800\u2009ng\u2009mL\u22121 Pb, Zn and Cd in six replicates which gave us RSDs of 2.08%, 2.15% and 2.11% for Pb, Zn and Cd, respectively. Inter-day precision was determined by the analysis of six replicates 800\u2009ng\u2009mL\u22121 Pb, Zn and Cd on three consecutive days which gave us RSDs of 2.34%, 2.28% and 2.21% for Pb, Zn and Cd, respectively. The results obtained for examination of intra-day and inter-day precision confirmed acceptable precisions for the developed methodology.The intra-day precision of the assay was estimated by calculating the relative standard deviation (4In this work, a novel and interesting analytical methodology based on coupling of spectrofluorimetry and chemometrics was developed for simultaneous determination of Pb, Cd and Zn in Hela cells. Among the tested chemometric algorithms, the OSC-PLS showed the best performance for simultaneous monitoring of Pb, Cd and Zn whose performance was comparable with AAS as reference method. The results of this work showed that chemometrics has a great potential for assisting instrumental techniques to develop accurate novel methods which have very better performance than those instrumental alone. As a new research field for our research group, we are going to continue coupling of chemometric method with instrumental techniques for bioanalytical purposes and definitely, this work will be a bridge to connect the world of chemometricians with the world of bioanalysts.The main idea of this project belongs to Dr. Ali R. Jalalvand and the other authors contributed equally in this project.The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.", "texts": ["In this work, we did our best to develop a novel and interesting analytical method based on coupling of spectrofluorimetry with first-order multivariate calibration techniques for simultaneous determination of lead (Pd), zinc (Zn) and cadmium (Cd) in HeLa cells. To achieve this goal, quenching of the emission of graphene (GR) was individually investigated in the presence of Pb, Zn and Cd and then, according to the linear ranges obtained from individual calibration graphs, a multivariate calibration model was developed based on modeling of the quenching of the emission of GR in the presence of the mixtures of Pb, Zn and Cd. First-order multivariate calibration models were constructed by partial least squares (PLS), principal component regression (PCR), orthogonal signal correction-PLS (OSC-PLS), continuum power regression (CPR), robust continuum regression (RCR) and partial robust M-regression (PRM) and their performances were evaluated and statistically compared. Finally, the OSC-PLS was chosen as the best model with the best practical performance for analytical purposes.  \u2022The GR was uptaken by the HeLa cells and then, the cells uptook Pb, Cd and Zn.\u2022Individual and multivariate calibration models were developed by the use of several first-order algorithms.\u2022Comparing the performance of the models was performed and the OSC-PLS showed the best performance.\u2022Performance of the OSC-PLS was compared with a reference method.\u2022Our records showed that the OSC-PLS had a comparable performance with the reference method. Sometimes, the heavy metals are considered as contaminants which can be hazardous for human health therefore, monitoring of them is important. Lead (Pb) and cadmium (Cd) are heavy metals which are widely and naturally distributed toxic metals. There are some reports on determination of these metals with zinc (Zn) HeLa is an immortal cell line which is the most commonly used human cell line in scientific research. The HeLa cell line is durable and prolific which make it to be extremely suitable for scientific research. Therefore in this study, we have used the HeLa cells as a very interesting case for developing a novel analytical method for simultaneous determination of the Pb, Cd and Zn.Chemometrics combines chemical data with mathematical and statistical methods to extract useful information which can help the chemists to better justify their observations. Chemometricians have performed different projects by the use of instrumental data 22.13)2 were purchased from Sigma. Commercial Pb, Cd and Zn standards (1\u2009g\u2009l\u22121) were prepared from Merck. Graphene quantum dots (blue luminescent) were purchased from Sigma-Aldrich. The other chemicals which were needed for doing this project were available in archive of our laboratory which had been purchased from Sigma or Merck. Doubly distilled water was used wherever water was needed. A phosphate buffer solution  was prepared from Na2HPO4 and its pH was adjusted at 7.4 by the use of H3PO4 and NaOH.Trypsin-EDTA, Dulbecco\u2019s modified Eagle\u2019s medium (DMEM/F-12 (1:1)), fetal bovine serum , penicillin-streptomycin (PEN-STREP), zinc nitrate hexahydrate, cadmium nitrate tetrahydrate and Pb(NO2.2Spectrofluorimetric data were recorded by a Cary Varian spectrofluorimeter equipped with a quartz cell (1\u2009cm length path). First-order multivariate calibration algorithms including PLS, PCR, OSC-PLS, CPR, RCR, PRM, smoothing of the data and elliptical joint confidence region (EJCR) were run in MATLAB (Version 7.5) by the use of a series of m-files. The first-order multivariate calibration algorithms have been run in MATLAB with the help of PLS-toolbox or TOMCAT. The HeLa cells were prepared from the cell bonk of Kermanshah University of Medical Sciences. Then, the flask was transferred into a culture room where a deep-freezer (\u221280\u2009\u00b0C), a memmert incubator, a JTLV CZS hood and a Motic microscope were existed for cell culturing. pH adjustments were performed by a Jenway pH meter 3510. Performance of the developed methodology was compared with the results of an Agilent atomic absorption spectrometer as reference method (AAS). Operating conditions for the AAS were: PMT voltage (450\u2009V), slit width (0.40\u2009nm), lamp current (9.0\u2009mA), sample volume (20\u2009\u00b5l), purging gas (argon), sample injection replicates (2) and measurement (peak height). All the calculations which were needed for data processing were performed on a Dell XPS laptop.2.32 +95% air) at 37\u2009\u00b0C during a day (24\u2009h). For uptaking the GR, 100\u2009ng\u2009mL\u22121 GR was added to different culture dishes and incubated at different times and then, the cells were washed with PBS  and left to be in the PBS.Dispersion of the HeLa cells were performed in DMEM +\u2009FBS (10%) +\u2009PEN-STREP (1%) and seeded on five confocal dishes and then, they were incubated at an humidified atmosphere  were added to the dishes. The cells were further incubated for 2\u2009h and washed with the PBS for three times and kept in the PBS. Spectrofluorimetric monitoring of the Pb, Cd and Zn was performed by excitation at 405\u2009nm. For performing background correction on the data, the control cells which had not been incubated with GR (didn\u2019t have any GR) was prepared. The procedures described above were continued by digestion of the treated and control cells with trypsin and then, the cells were kept in the PBS. Afterwards, the cells were counted, broken by ultrasonic and centrifuged. Finally, the supernatant of cells were measured spectrofluorimetrically.For simultaneous determination of Pb, Cd and Zn in HeLa cells, the seeded cells were allowed to grow during a day (24\u2009h) and 1\u2009mL DMEM having 1300\u2009ng\u2009mL2.4In this work, we are going to develop a novel spectrofluorimetric method assisted by chemometric methods which will enable us to simultaneous determine Pb, Cd and Zn in living cells. Data treatment and development of multivariate calibration models must be very carefully performed to achieve the final goal. Prior to data modeling, all the spectrofluorimetric data were treated according to the following equation RMSEP: root mean square error of prediction and REP: relative error of prediction):yact and ypred are nominal and predicted concentrations, respectively, and ymean is the mean of the nominal concentrations. n are the number of samples in the validation set. Precision and accuracy of the developed calibration models will be compared according to the ellipses of the EJCR as well. Univariate calibrations and multivariate calibration and validation sets were performed in internal medium of the cells and by digestion of the cells with trypsin, the medium was extracted. This is a very important advantage which causes having a same medium for calibration and validation of the method which can help us for exploiting first-order advantage.All the data used in this work after passing this correction step was used for the next steps. Emission of the control cells was subtracted from the emission of the all of the cells and the corrected emissions were used for developing multivariate calibration models. Background correction was performed on the whole of data by subtracting emission of the control cells from emission of the whole of sets. Performance of the calibration models will be compared by the use of the following equations  and PRM: number of LVs\u2009=\u20093 and PDC\u2009=\u20090.12. After application of the algorithms and optimization of their parameters and constructing multivariate calibration models, their performance was verified by their application to a validation set having cells with different concentrations of Pb, Cd and Zn whose composition is shown by In order to multivariate calibrate the emission of the GR with concentration of Pb, Cd and Zn, a central composite design was developed based on linear ranges obtained from individual calibration graphs. Composition of the calibration set is shown in In order to further verification of the performance of the spectrofluorimetric method assisted by OSC-PLS, the AAS was applied to the prediction of the concentrations of the validation set as reference method and the results are shown in RSD) for the analysis of 800\u2009ng\u2009mL\u22121 Pb, Zn and Cd in six replicates which gave us RSDs of 2.08%, 2.15% and 2.11% for Pb, Zn and Cd, respectively. Inter-day precision was determined by the analysis of six replicates 800\u2009ng\u2009mL\u22121 Pb, Zn and Cd on three consecutive days which gave us RSDs of 2.34%, 2.28% and 2.21% for Pb, Zn and Cd, respectively. The results obtained for examination of intra-day and inter-day precision confirmed acceptable precisions for the developed methodology.The intra-day precision of the assay was estimated by calculating the relative standard deviation (4In this work, a novel and interesting analytical methodology based on coupling of spectrofluorimetry and chemometrics was developed for simultaneous determination of Pb, Cd and Zn in Hela cells. Among the tested chemometric algorithms, the OSC-PLS showed the best performance for simultaneous monitoring of Pb, Cd and Zn whose performance was comparable with AAS as reference method. The results of this work showed that chemometrics has a great potential for assisting instrumental techniques to develop accurate novel methods which have very better performance than those instrumental alone. As a new research field for our research group, we are going to continue coupling of chemometric method with instrumental techniques for bioanalytical purposes and definitely, this work will be a bridge to connect the world of chemometricians with the world of bioanalysts.The main idea of this project belongs to Dr. Ali R. Jalalvand and the other authors contributed equally in this project.The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper."]}
{"representative": "We thank Dr. Landry and colleagues  for theiAdherence to dietary prescriptions is of pivotal importance in studies comparing different nutritional interventions. In our randomized clinical trial, self-reported dietary compliance was assessed by trained dietitians at 2 and 4 weeks of diet using semiquantitative food frequency questionnaires, according to previously described methods ,4. NutriAs already pointed out and discussed , a low-cLastly, participants\u2019 satisfaction with their assigned diet was not formally assessed and quantified in our study. However, none withdrew the diet or complained about its composition during the 4-week intervention, suggesting the feasibility of these dietary prescriptions, at least in the short term. In conclusion, our study emphasizes important differences in the effectiveness of two calorie-restricted eating patterns on weight loss and glucose homeostatic mechanisms in morbidly obese individuals. A great effort has been made to maximize participants\u2019 engagement to nutritional interventions and reduce heterogeneity, with the final aim to minimize the influence of dietary adherence on study findings.", "texts": ["We thank Dr. Landry and colleagues  for theiAdherence to dietary prescriptions is of pivotal importance in studies comparing different nutritional interventions. In our randomized clinical trial, self-reported dietary compliance was assessed by trained dietitians at 2 and 4 weeks of diet using semiquantitative food frequency questionnaires, according to previously described methods ,4. NutriAs already pointed out and discussed , a low-cLastly, participants\u2019 satisfaction with their assigned diet was not formally assessed and quantified in our study. However, none withdrew the diet or complained about its composition during the 4-week intervention, suggesting the feasibility of these dietary prescriptions, at least in the short term. In conclusion, our study emphasizes important differences in the effectiveness of two calorie-restricted eating patterns on weight loss and glucose homeostatic mechanisms in morbidly obese individuals. A great effort has been made to maximize participants\u2019 engagement to nutritional interventions and reduce heterogeneity, with the final aim to minimize the influence of dietary adherence on study findings."]}
{"representative": "The authors are listed out of order. The last author should be Paula Garcia Chiarello. Please view the correct author order, affiliations, and citation here:1, Gabriel Ruiz Sizoto2, Lorena Vega-Piris3, Guillermina Barril Cuadrado4, Paula Garcia Chiarello5Nat\u00e1lia Tomborelli Bellafronte1 Post-graduate Program in Health Sciences, Ribeir\u00e3o Preto Faculty of Medicine, University of S\u00e3o Paulo, Ribeir\u00e3o Preto, S\u00e3o Paulo, Brazil, 2 Nutrition and Metabolism Undergraduate Course, Ribeir\u00e3o Preto Faculty of Medicine, University of S\u00e3o Paulo, Ribeir\u00e3o Preto, S\u00e3o Paulo, Brazil, 3 Methodology Unit, Instituto de Investigaci\u00f3n Sanitaria del Hospital Universitario de la Princesa, Madrid, Spain, 4 Nephrology Department, Hospital Universitario La Princesa, Madrid, Spain, 5 Department of Health Sciences, Ribeir\u00e3o Preto Faculty of Medicine, University of S\u00e3o Paulo, Ribeir\u00e3o Preto, S\u00e3o Paulo, Brazilhttps://doi.org/10.1371/journal.pone.0242671Bellafronte NT, Sizoto GR, Vega-Piris L, Cuadrado GB, Chiarello PG (2020) Bed-side measures for diagnosis of low muscle mass, sarcopenia, obesity, and sarcopenic obesity in patients with chronic kidney disease under non-dialysis-dependent, dialysis dependent and kidney transplant therapy. PLoS ONE 15(11): e0242671.", "texts": ["The authors are listed out of order. The last author should be Paula Garcia Chiarello. Please view the correct author order, affiliations, and citation here:1, Gabriel Ruiz Sizoto2, Lorena Vega-Piris3, Guillermina Barril Cuadrado4, Paula Garcia Chiarello5Nat\u00e1lia Tomborelli Bellafronte1 Post-graduate Program in Health Sciences, Ribeir\u00e3o Preto Faculty of Medicine, University of S\u00e3o Paulo, Ribeir\u00e3o Preto, S\u00e3o Paulo, Brazil, 2 Nutrition and Metabolism Undergraduate Course, Ribeir\u00e3o Preto Faculty of Medicine, University of S\u00e3o Paulo, Ribeir\u00e3o Preto, S\u00e3o Paulo, Brazil, 3 Methodology Unit, Instituto de Investigaci\u00f3n Sanitaria del Hospital Universitario de la Princesa, Madrid, Spain, 4 Nephrology Department, Hospital Universitario La Princesa, Madrid, Spain, 5 Department of Health Sciences, Ribeir\u00e3o Preto Faculty of Medicine, University of S\u00e3o Paulo, Ribeir\u00e3o Preto, S\u00e3o Paulo, Brazilhttps://doi.org/10.1371/journal.pone.0242671Bellafronte NT, Sizoto GR, Vega-Piris L, Cuadrado GB, Chiarello PG (2020) Bed-side measures for diagnosis of low muscle mass, sarcopenia, obesity, and sarcopenic obesity in patients with chronic kidney disease under non-dialysis-dependent, dialysis dependent and kidney transplant therapy. PLoS ONE 15(11): e0242671."]}
{"representative": "Since reproductive interference in plants may occur through interspecific pollination, the effective range of reproductive interference may reflects the spatial range of interspecific pollination. Therefore, we hypothesized that the coexistence of congeners on a small spatial scale would be less likely to occur by chance but that such coexistence would be likely to occur on a scale larger than interspecific pollination frequently occur. In the present study, we tested this hypothesis using spatially explicit woody plant survey data. Contrary to our prediction, congeneric tree species often coexisted at the finest spatial scale and significant exclusive distribution was not detected. Our results suggest that cooccurrence of congeneric tree species is not structured by reproductive interference, and they indicate the need for further research to explore the factors that mitigate the effects of reproductive interference.In plants, negative reproductive interaction among closely related species ( However, the CRH has also been widely discussed  limits the coexistence of closely related species  are less likely to coexist by chance on a local scale  congeneric species do not coexist on a fine spatial scale where reproductive interference frequently occurs but coexist on a large spatial scale; and (2) on large scales where reproductive interference does not occur, congeneric species coexist while avoiding each other, resulting in an exclusive or checkerboard distribution .2) was located in the Kasugayama primary forest, Nara prefecture, western Japan (34\u203241\u2032N135\u203251\u2032E) (Sapium sebiferum and Nagia nagi (The study area (\u223c1 km35\u203251\u2032E) . Because35\u203251\u2032E) . In the 35\u203251\u2032E) ; howevergia nagi . The fieField studies were conducted from June to September 2015. In the study area, 30 transect plots (\u223c0.1 ha in size) at 200 m intervals were established . Tree spIn this study, we defined congeners as closely related species based on the definition by a priori-defined spatial scales . In this study we established 30 plots at 200 m intervals. A priori-defined spatial scales corresponded to the area of each plot extended horizontally.We employed the species-to-genus ratio (S/G ratio) as an indicator of intragenic interactions for the categorized tree, shrub, and liana species. The S/G ratio has long been used to describe community patterns and to infer levels of competitive interactions among species within genera . Note that there are differing opinions among researchers on whether the genus Prunus should be considered as a single genus or not .where N species, there are P\u00a0=\u00a0N(N\u00a0\u2212\u00a01)/2 species pairs; thus, the C-score is calculated as follows: For The C-score becomes larger as the two species occur more commonly across different plots. We simulated null models to compare the observed C-score with stochastic distributions. The null models, which were run 999 times for each species pair, randomly shuffles the number of species (\u03b1-diversity) among sampling locations while preserving the species occurrence totals (the plant density). All statistical analyses were performed using R software version 3.6.1 . EcoSimRAt the study site, we recorded 42 tree species  from 31 genera, 20 shrub species  from 19 genera, and seven liana species from six genera . The resultant S/G ratios for trees, shrubs, and lianas were 1.350, 1.021, and 1.200, respectively. Only the S/G ratio for tree species significantly deviated from the 1:1 ratio, whereas those for shrub and liana species did not .The average S/G for trees increased as spatial scale increased. Even at the smallest spatial scale, however, the average S/G ratio for trees exceeded the 1:1 ratio , indicatQuercus, Carpinus, and Prunus. It indicates that statistically significant exclusive distribution of species from the same genus did not occur . Since a low S/G ratio is generally a product of strong intrageneric competition  is within a few tens of meters (Quercus, shows considerable variation in annual seed production (In plants, the spatial extent of reproductive interference corresponds to pollen transfer distance ; consequf meters . This suf meters . One of oduction , which moduction . Eaton ePrevious studies reveal that specialist natural enemies, such as herbivores and pathogens, maintain tree species diversity by the reducing survival rates of conspecific seeds and seedlings located close to reproductive adults or in high conspecific density areas (Janzen\u2013Connell effect; In future research, investigation on a larger spatial scale with a more complex analysis will be required to determine the relationship between plant life history and the spatial scale of exclusive distribution. Previous studies on herbaceous plants suggest that reproductive interference plays an important role in community assembly ; however10.7717/peerj.12150/supp-1Supplemental Information 1Click here for additional data file.10.7717/peerj.12150/supp-2Supplemental Information 2Click here for additional data file.10.7717/peerj.12150/supp-3Supplemental Information 3Click here for additional data file.10.7717/peerj.12150/supp-4Supplemental Information 4Click here for additional data file.", "texts": ["Since reproductive interference in plants may occur through interspecific pollination, the effective range of reproductive interference may reflects the spatial range of interspecific pollination. Therefore, we hypothesized that the coexistence of congeners on a small spatial scale would be less likely to occur by chance but that such coexistence would be likely to occur on a scale larger than interspecific pollination frequently occur. In the present study, we tested this hypothesis using spatially explicit woody plant survey data. Contrary to our prediction, congeneric tree species often coexisted at the finest spatial scale and significant exclusive distribution was not detected. Our results suggest that cooccurrence of congeneric tree species is not structured by reproductive interference, and they indicate the need for further research to explore the factors that mitigate the effects of reproductive interference.In plants, negative reproductive interaction among closely related species ( However, the CRH has also been widely discussed  limits the coexistence of closely related species  are less likely to coexist by chance on a local scale  congeneric species do not coexist on a fine spatial scale where reproductive interference frequently occurs but coexist on a large spatial scale; and (2) on large scales where reproductive interference does not occur, congeneric species coexist while avoiding each other, resulting in an exclusive or checkerboard distribution .2) was located in the Kasugayama primary forest, Nara prefecture, western Japan (34\u203241\u2032N135\u203251\u2032E) (Sapium sebiferum and Nagia nagi (The study area (\u223c1 km35\u203251\u2032E) . Because35\u203251\u2032E) . In the 35\u203251\u2032E) ; howevergia nagi . The fieField studies were conducted from June to September 2015. In the study area, 30 transect plots (\u223c0.1 ha in size) at 200 m intervals were established . Tree spIn this study, we defined congeners as closely related species based on the definition by a priori-defined spatial scales . In this study we established 30 plots at 200 m intervals. A priori-defined spatial scales corresponded to the area of each plot extended horizontally.We employed the species-to-genus ratio (S/G ratio) as an indicator of intragenic interactions for the categorized tree, shrub, and liana species. The S/G ratio has long been used to describe community patterns and to infer levels of competitive interactions among species within genera . Note that there are differing opinions among researchers on whether the genus Prunus should be considered as a single genus or not .where N species, there are P\u00a0=\u00a0N(N\u00a0\u2212\u00a01)/2 species pairs; thus, the C-score is calculated as follows: For The C-score becomes larger as the two species occur more commonly across different plots. We simulated null models to compare the observed C-score with stochastic distributions. The null models, which were run 999 times for each species pair, randomly shuffles the number of species (\u03b1-diversity) among sampling locations while preserving the species occurrence totals (the plant density). All statistical analyses were performed using R software version 3.6.1 . EcoSimRAt the study site, we recorded 42 tree species  from 31 genera, 20 shrub species  from 19 genera, and seven liana species from six genera . The resultant S/G ratios for trees, shrubs, and lianas were 1.350, 1.021, and 1.200, respectively. Only the S/G ratio for tree species significantly deviated from the 1:1 ratio, whereas those for shrub and liana species did not .The average S/G for trees increased as spatial scale increased. Even at the smallest spatial scale, however, the average S/G ratio for trees exceeded the 1:1 ratio , indicatQuercus, Carpinus, and Prunus. It indicates that statistically significant exclusive distribution of species from the same genus did not occur . Since a low S/G ratio is generally a product of strong intrageneric competition  is within a few tens of meters (Quercus, shows considerable variation in annual seed production (In plants, the spatial extent of reproductive interference corresponds to pollen transfer distance ; consequf meters . This suf meters . One of oduction , which moduction . Eaton ePrevious studies reveal that specialist natural enemies, such as herbivores and pathogens, maintain tree species diversity by the reducing survival rates of conspecific seeds and seedlings located close to reproductive adults or in high conspecific density areas (Janzen\u2013Connell effect; In future research, investigation on a larger spatial scale with a more complex analysis will be required to determine the relationship between plant life history and the spatial scale of exclusive distribution. Previous studies on herbaceous plants suggest that reproductive interference plays an important role in community assembly ; however10.7717/peerj.12150/supp-1Supplemental Information 1Click here for additional data file.10.7717/peerj.12150/supp-2Supplemental Information 2Click here for additional data file.10.7717/peerj.12150/supp-3Supplemental Information 3Click here for additional data file.10.7717/peerj.12150/supp-4Supplemental Information 4Click here for additional data file."]}
{"representative": "Hartmann\u2019s procedure involves resecting the rectosigmoid colon, closure of the distal rectal stump, and forming an end colostomy for complicated left colon diverticulitis or malignancy. Recovery from the initial operation can, in a second stage, be followed by a reversal stage with the restoration of bowel continuity. This study aimed to assess the reversal rate and its correlation with demographic data, ASA grade, and length of hospital stay. All patients who underwent Hartmann\u2019s emergency procedure from 2014 to 2018 at Lewisham and Greenwich hospital were enrolled in this retrospective study. Data was collected from the inpatient electronic files and NELA . 118 patients were included in the study, with 57.6% females and a median age of patients of 69 years (range 35\u201391). Findings of the study indicate that the most common indications for Hartmann\u2019s procedure were diverticular complications 60% (n=71) and benign perforated sigmoid or rectosigmoid cancer 16% (n=19). The average length of hospital stay was 24 days (range n=2 \u2013 212 days). The reversal rate was 34.9% (41/118 cases). No significant difference was observed between gender and length of hospital stay in relation to the reversal rate while there was a significant correlation between age and ASA grade in relation to reversal rate; the calculated P values were recorded as (<0.000) and (<0.009) respectively. Our results show that the highest reversal rate was observed in younger and fitter (I\u2013II) ASA grade patients. The most common medical complication from reversal of Hartmann\u2019s procedure was an anastomotic leak . Reversal rate of Hartmann\u2019s procedure was 34.9%. The average timeframe for reversal was within 18\u201320 months. There was a significant correlation between age and ASA grade in relation to reversal rate. In the early twenties of the past century, the French surgeon Henri Albert Hartmann introduced and described a surgical procedure for obstructive rectosigmoid cancer in 1921, with postoperative sequel superordinate for other surgical techniques. Hartmann\u2019s procedure is defined as a surgical procedure that mainly includes rectosigmoid resection and closure of rectal stump plus establishment of an end colostomy . MoreoveAmerican Society of Anesthesiologists Physical Status (ASA PS) classification was first implemented in clinical practice more than seventy years ago to classify patients according to tolerance and fitness for specific surgical procedures. The ASA class is a subjective evaluation of a patient\u2019s overall health, and it only measures the amount of physiological allowance that a patient has at the time they are evaluated for a surgical procedure. Also, it should not be used as the only indicator of an operative risk to the patient . ASA scoOur study aims to identify the factors that affect the reversal rate, mainly the age, gender and ASA grade, and length of hospital stay . In addiThis is a retrospective observational study. All patients who underwent emergency Hartmann\u2019s procedure between 2014 and 2018 at Lewisham and Greenwich hospitals were identified and included. We excluded patients who have their Hartmann\u2019s procedure on an elective basis. The cases were retrieved from a computerized medical records database and NELA  bowel database. Analysis was completed by examining the inpatient files in selected patients where appropriate. Collected data included the following parameters: demographics, indications for Hartmann\u2019s procedure, duration of the surgery, hospital stay, ASA grade, and reversal rate. In addition, the type of surgery (open or laparoscopic) covering ileostomy and postoperative complications was collected for patients who underwent a reversal. All the reversal procedures were performed by qualified colorectal surgeons, while the original Hartmann\u2019s procedure was performed by a mixture of emergency surgeons, general surgeons, and colorectal surgeons. Data analysis was performed using the SPSS software. A chi-squared test was used to assess categorical variables. A p-value of less than <0.05 was considered to be statistically significant.A total of 118 patients were identified during the study period from 2014 to 2018 at Lewisham and Greenwich hospital. 68 (57.6%) of the 118 patients were female. The median age was 69 years (range from 35 to 91). A substantial proportion of patients were ASA grade III\u2013V , as summarized in Sigmoidoscopy to assess the rectal stump length and colonoscopy through the stoma to rule out residual proximal pathology were routinely performed prior to reversal. The reversal rate of Hartmann\u2019s procedure was 34.7% (41/118 cases). Seventy-seven patients (65%) did not proceed to reversal . The reaForty-one patients underwent successful reversal (34.9%). Defunctioning ileostomy was used in 10 patients (24%), an anastomotic leak occurred in 6 patients (14.6%). The operative time mean was 3 hrs.15 min, and the average length of hospital stay following reversal was 11 days (range 2\u2013159 days). The Chi-square test was used to determine the significance of differences between the reversal rate of Hartmann\u2019s procedure and the demographic data of the patients, ASA grade, and length of hospital stay . No signet al. [et al. [et al. [This study involved the selection of 118 consecutive patients who underwent Hartmann\u2019s procedure to measure the reversal rate and mortality rate and assess the correlation between demographic data, ASA grade, length of hospital stay, and the reversal rate of Hartmann\u2019s procedure. The most common indication for Hartmann\u2019s procedure in our study was diverticular complications (60%), similar to the studies conducted by Hallam et al.  and Chri [et al. , while t [et al.  was coloet al. [et al. [In this study, the reversal rate of Hartmann\u2019s procedure was assessed. 34.9% of the patients underwent a successful reversal, which is higher to previously reported data by Christou et al. , where o [et al. , who repet al. (16.1%) [et al. observed a low rate of laparoscopic surgery for a colostomy reversal. However, good results have been published with its use, and a laparoscopic reversal is comparable or superior to open reversal [et al. [Thirty-day mortality following Hartmann\u2019s procedure was 16.9%; it was higher in those aged above 80 years. This was in accordance with previously reported results by Zarnescu  (16.1%) . It woulreversal . Post re [et al.  was diaret al. [Our results revealed that there was no significant difference between gender and reversal rate (p<0.737), while a significant relation was observed between age (p<0.001) and ASA grade (p<0.009) in relation to reversal rate, the highest reversal rate was observed in younger and (I\u2013II) ASA grade patients. In addition, there was a higher rate of reversal in benign conditions than malignant conditions. These results were in accordance with previous results reported by Hallam et al. , where tThere are several other surgical trends to approach the management of diverticular complications or obstructed rectosigmoid tumors, such as colonic stent insertion and primary anastomosis with or without a stoma. The colonic stent can convert the emergency surgery to a semi-elective surgery which allows more time for patient optimization and a procedure performed by a colorectal surgeon. Primary anastomosis with or without diverting ileostomy is another option that can save the patient from undergoing another major and morbid surgery. This latter approach was not adopted in our current study as most of Hartmann\u2019s procedures were performed by emergency consultants who are not specialized in colorectal surgery and only occasionally perform colon resections. On the other hand, colorectal surgeons performed all reversal operations, who conducted primary anastomosis and diverting ileostomy in one-quarter of the reversed patients. Moving towards centralizing services with 24 hours access to colorectal surgeons may reduce the number of Hartmann\u2019s procedures performed overall. In addition, providing up-to-date information on the management of those common problems in the surgical department is crucial.One limitation of our study is the retrospective data collection from a dual centers group, involving many surgeons not necessarily specialized in colorectal surgery. Second, our patient group was rather heterogeneous. However, this variety in the patient mix was a caveat to assess possible risk factors for non-reversal. The value of our study is that it demonstrates that Hartmann\u2019s procedure is still a very prevalent surgery that carries high mortality and morbidity, but it can still save lives in high-risk comorbid patients, and by implementing new evolving surgical options, we can improve the quality of patient care.In conclusion, Hartmann\u2019s procedure is still a commonly performed emergency colorectal operation. Reversal rate of Hartmann\u2019s procedure was 34.9%. The predicted mortality on NELA v/s actual mortality is an important figure to compare to identify areas needing a particular focus. The number of patients turned down for reversal may well reflect the poor general health of the cohort and may have a relation to the low socioeconomic status of the population in this area. As expected, there is a significant correlation between age and ASA grade in relation to reversal rate. Our high comorbidity rate and high ASA grade may have contributed to the high leakage rate.The authors declare that there is no conflict of interest.The study was approved by the Audit Committee of the Lewisham and Greenwich Trust .Written informed consent was obtained from the participants in the study.MF contributed to data collection and writing the article. PS, RK, and OO designed the methodology and PN reviewed the article.", "texts": ["Hartmann\u2019s procedure involves resecting the rectosigmoid colon, closure of the distal rectal stump, and forming an end colostomy for complicated left colon diverticulitis or malignancy. Recovery from the initial operation can, in a second stage, be followed by a reversal stage with the restoration of bowel continuity. This study aimed to assess the reversal rate and its correlation with demographic data, ASA grade, and length of hospital stay. All patients who underwent Hartmann\u2019s emergency procedure from 2014 to 2018 at Lewisham and Greenwich hospital were enrolled in this retrospective study. Data was collected from the inpatient electronic files and NELA . 118 patients were included in the study, with 57.6% females and a median age of patients of 69 years (range 35\u201391). Findings of the study indicate that the most common indications for Hartmann\u2019s procedure were diverticular complications 60% (n=71) and benign perforated sigmoid or rectosigmoid cancer 16% (n=19). The average length of hospital stay was 24 days (range n=2 \u2013 212 days). The reversal rate was 34.9% (41/118 cases). No significant difference was observed between gender and length of hospital stay in relation to the reversal rate while there was a significant correlation between age and ASA grade in relation to reversal rate; the calculated P values were recorded as (<0.000) and (<0.009) respectively. Our results show that the highest reversal rate was observed in younger and fitter (I\u2013II) ASA grade patients. The most common medical complication from reversal of Hartmann\u2019s procedure was an anastomotic leak . Reversal rate of Hartmann\u2019s procedure was 34.9%. The average timeframe for reversal was within 18\u201320 months. There was a significant correlation between age and ASA grade in relation to reversal rate. In the early twenties of the past century, the French surgeon Henri Albert Hartmann introduced and described a surgical procedure for obstructive rectosigmoid cancer in 1921, with postoperative sequel superordinate for other surgical techniques. Hartmann\u2019s procedure is defined as a surgical procedure that mainly includes rectosigmoid resection and closure of rectal stump plus establishment of an end colostomy . MoreoveAmerican Society of Anesthesiologists Physical Status (ASA PS) classification was first implemented in clinical practice more than seventy years ago to classify patients according to tolerance and fitness for specific surgical procedures. The ASA class is a subjective evaluation of a patient\u2019s overall health, and it only measures the amount of physiological allowance that a patient has at the time they are evaluated for a surgical procedure. Also, it should not be used as the only indicator of an operative risk to the patient . ASA scoOur study aims to identify the factors that affect the reversal rate, mainly the age, gender and ASA grade, and length of hospital stay . In addiThis is a retrospective observational study. All patients who underwent emergency Hartmann\u2019s procedure between 2014 and 2018 at Lewisham and Greenwich hospitals were identified and included. We excluded patients who have their Hartmann\u2019s procedure on an elective basis. The cases were retrieved from a computerized medical records database and NELA  bowel database. Analysis was completed by examining the inpatient files in selected patients where appropriate. Collected data included the following parameters: demographics, indications for Hartmann\u2019s procedure, duration of the surgery, hospital stay, ASA grade, and reversal rate. In addition, the type of surgery (open or laparoscopic) covering ileostomy and postoperative complications was collected for patients who underwent a reversal. All the reversal procedures were performed by qualified colorectal surgeons, while the original Hartmann\u2019s procedure was performed by a mixture of emergency surgeons, general surgeons, and colorectal surgeons. Data analysis was performed using the SPSS software. A chi-squared test was used to assess categorical variables. A p-value of less than <0.05 was considered to be statistically significant.A total of 118 patients were identified during the study period from 2014 to 2018 at Lewisham and Greenwich hospital. 68 (57.6%) of the 118 patients were female. The median age was 69 years (range from 35 to 91). A substantial proportion of patients were ASA grade III\u2013V , as summarized in Sigmoidoscopy to assess the rectal stump length and colonoscopy through the stoma to rule out residual proximal pathology were routinely performed prior to reversal. The reversal rate of Hartmann\u2019s procedure was 34.7% (41/118 cases). Seventy-seven patients (65%) did not proceed to reversal . The reaForty-one patients underwent successful reversal (34.9%). Defunctioning ileostomy was used in 10 patients (24%), an anastomotic leak occurred in 6 patients (14.6%). The operative time mean was 3 hrs.15 min, and the average length of hospital stay following reversal was 11 days (range 2\u2013159 days). The Chi-square test was used to determine the significance of differences between the reversal rate of Hartmann\u2019s procedure and the demographic data of the patients, ASA grade, and length of hospital stay . No signet al. [et al. [et al. [This study involved the selection of 118 consecutive patients who underwent Hartmann\u2019s procedure to measure the reversal rate and mortality rate and assess the correlation between demographic data, ASA grade, length of hospital stay, and the reversal rate of Hartmann\u2019s procedure. The most common indication for Hartmann\u2019s procedure in our study was diverticular complications (60%), similar to the studies conducted by Hallam et al.  and Chri [et al. , while t [et al.  was coloet al. [et al. [In this study, the reversal rate of Hartmann\u2019s procedure was assessed. 34.9% of the patients underwent a successful reversal, which is higher to previously reported data by Christou et al. , where o [et al. , who repet al. (16.1%) [et al. observed a low rate of laparoscopic surgery for a colostomy reversal. However, good results have been published with its use, and a laparoscopic reversal is comparable or superior to open reversal [et al. [Thirty-day mortality following Hartmann\u2019s procedure was 16.9%; it was higher in those aged above 80 years. This was in accordance with previously reported results by Zarnescu  (16.1%) . It woulreversal . Post re [et al.  was diaret al. [Our results revealed that there was no significant difference between gender and reversal rate (p<0.737), while a significant relation was observed between age (p<0.001) and ASA grade (p<0.009) in relation to reversal rate, the highest reversal rate was observed in younger and (I\u2013II) ASA grade patients. In addition, there was a higher rate of reversal in benign conditions than malignant conditions. These results were in accordance with previous results reported by Hallam et al. , where tThere are several other surgical trends to approach the management of diverticular complications or obstructed rectosigmoid tumors, such as colonic stent insertion and primary anastomosis with or without a stoma. The colonic stent can convert the emergency surgery to a semi-elective surgery which allows more time for patient optimization and a procedure performed by a colorectal surgeon. Primary anastomosis with or without diverting ileostomy is another option that can save the patient from undergoing another major and morbid surgery. This latter approach was not adopted in our current study as most of Hartmann\u2019s procedures were performed by emergency consultants who are not specialized in colorectal surgery and only occasionally perform colon resections. On the other hand, colorectal surgeons performed all reversal operations, who conducted primary anastomosis and diverting ileostomy in one-quarter of the reversed patients. Moving towards centralizing services with 24 hours access to colorectal surgeons may reduce the number of Hartmann\u2019s procedures performed overall. In addition, providing up-to-date information on the management of those common problems in the surgical department is crucial.One limitation of our study is the retrospective data collection from a dual centers group, involving many surgeons not necessarily specialized in colorectal surgery. Second, our patient group was rather heterogeneous. However, this variety in the patient mix was a caveat to assess possible risk factors for non-reversal. The value of our study is that it demonstrates that Hartmann\u2019s procedure is still a very prevalent surgery that carries high mortality and morbidity, but it can still save lives in high-risk comorbid patients, and by implementing new evolving surgical options, we can improve the quality of patient care.In conclusion, Hartmann\u2019s procedure is still a commonly performed emergency colorectal operation. Reversal rate of Hartmann\u2019s procedure was 34.9%. The predicted mortality on NELA v/s actual mortality is an important figure to compare to identify areas needing a particular focus. The number of patients turned down for reversal may well reflect the poor general health of the cohort and may have a relation to the low socioeconomic status of the population in this area. As expected, there is a significant correlation between age and ASA grade in relation to reversal rate. Our high comorbidity rate and high ASA grade may have contributed to the high leakage rate.The authors declare that there is no conflict of interest.The study was approved by the Audit Committee of the Lewisham and Greenwich Trust .Written informed consent was obtained from the participants in the study.MF contributed to data collection and writing the article. PS, RK, and OO designed the methodology and PN reviewed the article."]}
{"representative": "Food is an integral part of human culture. Aside from its nutritional role, it connects us on a daily basis through the act of sitting and eating together, it contributes to feelings of shared identity in populations, it is an essential component of many formative events in our lives, and is a gateway to experiencing new cultures.While the influence of food in defining human culture is well-understood, there is a growing appreciation of the role of microbial cultures in defining the properties of food. Archaeological evidence points to the use of fermentation over many thousands of years for the production of a range of foods and beverages. Fermentation serves to make foods more digestible, longer-lasting, safer, and more palatable. For our species, the role of fermentation in food production has arguably been as influential as the role of fire for cooking food.For much of our history, these fermentation processes have been carried out by complex assemblages of organisms, with the use of single strains for fermentation of bread, beer, wine, etc. being a relatively recent development. We have however been seeing a growing interest in the use of microbial communities in food production. In the western world, this revival has been driven in part by the popularity of craft beer, natural wine, fermented non-alcoholic beverages , and sourdough bread. In other parts of the world, complex cultures in fermentation represent continuation of tradition rather than revival.This Research Topic from Frontiers in Microbiology aims to highlight the beneficial role of microbial complexity in driving fermentation processes and influencing food quality. The issue features ten articles describing investigations into complex microbial fermentation for the production of food, feed, and beverages. Contributions were received from Africa, Asia, Australia, Europe, and South America\u2014highlighting the global importance of fermentation. Demonstrated benefits of particular communities during fermentation include improved flavor and color, greater safety, increased nutritional value, faster fermentation rates, reduced alcohol content, and better industrial applicability.Elhalis et al., who show improved sensory properties of coffee after fermentation with the yeast Pichia Kudriavzevii. Likewise, K\u00f6hler et al. note how specific yeast and bacteria combinations can improve the flavor of water kefir. Liu et al. describe the relationship between bacterial composition and flavor profile of Xifeng liquor (a spirit prepared from fermented sorghum).One of the most direct impacts of fermentation is the creation of specific flavor profiles. We see this in the work of Su et al. for example, note how fermentation of corn by-products with Saccharomyces yeast and lactic acid bacteria can improve their suitability for use as feed. Dahunsi et al. provide a comprehensive account of how the presence of lactic acid bacteria within fermentative microbial consortia have a critical role in ensuring the safety and shelf-life of many fermented African foods. Likewise, Huang et al. describe the metabolites produced by the yeast Debaryomyces hansenii can prevent the growth of contaminant molds during Danish cheese production.Palatability of foods is not the only factor influenced by fermentation. Benefits extend also to improved digestibility and safety. Martinez et al. who describe how coffee fermentation is influenced by altitude, and how this is associated with changes in the natural microbiota. Substrate also influences the development of populations, as illustrated by Liu et al. who show how different microbial communities develop depending on the type of sorghum used in Xifeng liquour production. Su et al. likewise show how communities develop differently in different by-products of the corn starch industry. These, and other studies described in this Research Topic, demonstrate the power of high-throughput sequencing in studying microbial communities. This is particularly important for dynamic, complex or under-researched communities. This is exemplified in the studies on dark tea fermentation by Yan et al. or the work of Atter et al. on Ghanian cereal fermentation.The composition of species in a fermenting culture is strongly impacted by the environment, a fact that must be considered when trying to control or direct fermentation processes. The effect of environment is clearly seen in the study of Huang et al. coffee fermentation by Elhalis et al. and water kefir production by K\u00f6hler et al.Despite the advantages of complex fermentations with respect to product quality, it should be noted that industrial application of such cultures is not without complications. More complexity may lead to less consistency in fermentation processes. The controlled use of cultures, e.g., supplementing natural microbial consortia with specific species, or rationalizing consortia so that they contain only the keystone species, represents a compromise in this respect. Examples are seen here in the work on cheese production by Complex fermentations demonstrate great potential for improving food process efficiency, enhancing food quality, and increasing diversity of available foods and beverages. It is clear however that our ability to fully exploit such fermentations is limited by insufficient knowledge of how individuals in mixed populations interact to influence each other and their environment. It is our hope that this Research Topic represents a step forward in our understanding of these complex systems, and will to some extent facilitate the efficient production of a range of high quality food products in the future.All authors listed have made a substantial, direct, and intellectual contribution to the work and approved it for publication.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.", "texts": ["Food is an integral part of human culture. Aside from its nutritional role, it connects us on a daily basis through the act of sitting and eating together, it contributes to feelings of shared identity in populations, it is an essential component of many formative events in our lives, and is a gateway to experiencing new cultures.While the influence of food in defining human culture is well-understood, there is a growing appreciation of the role of microbial cultures in defining the properties of food. Archaeological evidence points to the use of fermentation over many thousands of years for the production of a range of foods and beverages. Fermentation serves to make foods more digestible, longer-lasting, safer, and more palatable. For our species, the role of fermentation in food production has arguably been as influential as the role of fire for cooking food.For much of our history, these fermentation processes have been carried out by complex assemblages of organisms, with the use of single strains for fermentation of bread, beer, wine, etc. being a relatively recent development. We have however been seeing a growing interest in the use of microbial communities in food production. In the western world, this revival has been driven in part by the popularity of craft beer, natural wine, fermented non-alcoholic beverages , and sourdough bread. In other parts of the world, complex cultures in fermentation represent continuation of tradition rather than revival.This Research Topic from Frontiers in Microbiology aims to highlight the beneficial role of microbial complexity in driving fermentation processes and influencing food quality. The issue features ten articles describing investigations into complex microbial fermentation for the production of food, feed, and beverages. Contributions were received from Africa, Asia, Australia, Europe, and South America\u2014highlighting the global importance of fermentation. Demonstrated benefits of particular communities during fermentation include improved flavor and color, greater safety, increased nutritional value, faster fermentation rates, reduced alcohol content, and better industrial applicability.Elhalis et al., who show improved sensory properties of coffee after fermentation with the yeast Pichia Kudriavzevii. Likewise, K\u00f6hler et al. note how specific yeast and bacteria combinations can improve the flavor of water kefir. Liu et al. describe the relationship between bacterial composition and flavor profile of Xifeng liquor (a spirit prepared from fermented sorghum).One of the most direct impacts of fermentation is the creation of specific flavor profiles. We see this in the work of Su et al. for example, note how fermentation of corn by-products with Saccharomyces yeast and lactic acid bacteria can improve their suitability for use as feed. Dahunsi et al. provide a comprehensive account of how the presence of lactic acid bacteria within fermentative microbial consortia have a critical role in ensuring the safety and shelf-life of many fermented African foods. Likewise, Huang et al. describe the metabolites produced by the yeast Debaryomyces hansenii can prevent the growth of contaminant molds during Danish cheese production.Palatability of foods is not the only factor influenced by fermentation. Benefits extend also to improved digestibility and safety. Martinez et al. who describe how coffee fermentation is influenced by altitude, and how this is associated with changes in the natural microbiota. Substrate also influences the development of populations, as illustrated by Liu et al. who show how different microbial communities develop depending on the type of sorghum used in Xifeng liquour production. Su et al. likewise show how communities develop differently in different by-products of the corn starch industry. These, and other studies described in this Research Topic, demonstrate the power of high-throughput sequencing in studying microbial communities. This is particularly important for dynamic, complex or under-researched communities. This is exemplified in the studies on dark tea fermentation by Yan et al. or the work of Atter et al. on Ghanian cereal fermentation.The composition of species in a fermenting culture is strongly impacted by the environment, a fact that must be considered when trying to control or direct fermentation processes. The effect of environment is clearly seen in the study of Huang et al. coffee fermentation by Elhalis et al. and water kefir production by K\u00f6hler et al.Despite the advantages of complex fermentations with respect to product quality, it should be noted that industrial application of such cultures is not without complications. More complexity may lead to less consistency in fermentation processes. The controlled use of cultures, e.g., supplementing natural microbial consortia with specific species, or rationalizing consortia so that they contain only the keystone species, represents a compromise in this respect. Examples are seen here in the work on cheese production by Complex fermentations demonstrate great potential for improving food process efficiency, enhancing food quality, and increasing diversity of available foods and beverages. It is clear however that our ability to fully exploit such fermentations is limited by insufficient knowledge of how individuals in mixed populations interact to influence each other and their environment. It is our hope that this Research Topic represents a step forward in our understanding of these complex systems, and will to some extent facilitate the efficient production of a range of high quality food products in the future.All authors listed have made a substantial, direct, and intellectual contribution to the work and approved it for publication.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher."]}
{"representative": "A comprehensive review of\u00a0relevant clinical literature on evidence-based recommendations and existing prediction models specific to lung cancer surgery was undertaken. Preoperative risk assessment parameters such as pulmonary function tests (PFT), cardiopulmonary exercise testing (CPET), Brunelli models, Thoracoscore and frailty were analyzed for\u00a0predicting postoperative risk of complications.\u00a0(DLCO ) showed conflicting evidence in determining a positive correlation with postoperative mortality. CPET variables predicted higher complication risk when\u00a0VO2peak < 10ml/kg/min, AT < 11ml/kg/min and ventilation/carbon dioxide production (VE/VCO2) was in range of 34-40. While a cardiac risk index like the Thoracic Revised Cardiac Risk Index (ThRCRI) predicted major cardiovascular compromise, a\u00a0thoracic risk index like Thoracoscore proved imprecise. Lastly, frailty is used to risk stratify patients in clinical practice but a recognized validated model specific to thoracic surgery is non-existent.When assessing fitness for surgery, the primarily used PFT parameters such as predictive postoperative forced expiratory volume in one second (FEV1) and diffusion capacity for carbon monoxideWhen considering patients for lung cancer surgery, some dilemma exists regarding the accuracy of clinical prediction models and their external validation. There is a pressing need for the development of a consolidated clinically robust risk stratification model to predict complications after thoracic resections. Lung cancer is the leading cause of oncological deaths worldwide .\u00a0It is aTreatment of early-stage lung cancer primarily involves surgical resection as it delivers a strong probability of cure . DespiteThis highlights the need to risk stratify to predict mortality, morbidity and long-term shortness of breath in lung cancer patients.\u00a0In the last decade, an increasing amount of literature has addressed the role of various parameters used in preoperative risk assessment. This often involves cardiorespiratory evaluation in conjunction with assessment of operative mortality, lung function and exercise testing. More recently, there has been an emphasis on frailty as a significant surgical risk factor and practical screening tool.\u00a0Individual preoperative investigations such as pulmonary function tests (PFT), cardiopulmonary exercise testing (CPET), Brunelli models, Thoracoscore and frailty can be useful in clinical practice and the accuracy of these in predicting postoperative risk has been analyzed in this article.\u00a0Pulmonary function testsppoFEV1Assessment of pulmonary function parameters such as forced expiratory volume in one second\u00a0(FEV1) and predicted postoperative FEV1 (ppoFEV1) is important in-patient selection for lung cancer surgery. This is to evaluate the possibility of postoperative pulmonary complications (PPC)\u00a0and operative mortality, defined as death within 30 days of surgery. Patients with an estimated ppoFEV1>40% are considered as having an average risk, and high risk is determined by an estimated ppoFEV1 <40% [Various small studies have been carried out at local or regional units to establish the risk indicators for developing PPC. A four-year prospective observational study of 285 patients undergoing video-assisted thoracoscopic surgery (VATS) for non-small cell lung cancer (NSCLC) was carried out. Data on gender, age, predicted %FEV1, ASA score, perioperative activity level, BMI, smoking status, and NSCLC staging were recorded. Of the 21 participants who went on to develop postoperative pulmonary complications, the percentage of predicted FEV1 was 88.8% compared with 87.5% in patients who did not develop complications. Predicted %FEV1 was not found to be a significant independent risk factor in determining PPC such as pneumonia, atelectasis, longer hospital stays in high-dependency units or admission to intensive care following VATS   and %FEV1 was collected. A cut-off value of 70% for FEV1 was defined as obstructive ventilatory impairment. In Japan, FEV1\u00a0of less than 70% is defined as obstructive ventilatory impairment which is in contrast to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification. Postoperative complications were present in 35% of patients with a %FEV1 <70% compared to 23% of patients with an FEV1 \u226570%.\u00a0Univariate analysis showed that FEV1 <70% was associated with a greater risk of postoperative atelectasis, pneumonia, and air leakage. These findings oppose the aforementioned studies likely due to the larger population size and demonstrate %FEV1 as an important predictor and significant risk factor of postoperative complications [Moreover, a study using whole lung CT to determine preoperative pulmonary function was carried out in 390 patients who underwent resection for lung cancer. The development cohort had 290 patients and 100 patients formed the validation cohort. Whole lung CT along with patient demographics was used to develop a regression equation for FEV1 to determine preoperative pulmonary function and ppoFEV1. The ppoFEV1 was also calculated based on the anatomic equation: measured %FEV1 x (42 - number of subsegments resected)/42. Both regression analysis and actual measured FEV1/FVC, %FEV1 and %ppoFEV1 were shown to be significant variables associated with predicting postoperative cardiopulmonary complications in both cohorts. Both calculated ppoFEV1 and actual ppoFEV1 were positively correlated with the occurrence of PPC . The useTaking these studies into account, pulmonary function parameters continue to provide conflicting evidence for their ability to predict postoperative complications. The smaller population size of these studies is a limiting factor and we need stronger studies collaborated at national or international units to improve reliabilityDiffusion capacity for carbon monoxide (DLCO)In addition to spirometric parameters, the diffusion capacity for carbon monoxide (DLCO), also known as the transfer factor for carbon monoxide (TLCO), is considered in most preoperative assessments in addition to ppoFEV1. DLCO is based on the ability of carbon monoxide to bind to haemoglobin, therefore DLCO represents the efficiency of gas transfer from inspired air into red blood cells. A low DLCO predicts (a) a higher likelihood of pulmonary complications requiring either supplemental oxygen or hospitalization and (b) a worse dyspnea score. DLCO is also strongly associated with the risk of higher operative mortality . DLCO isA prospective study involving 351 patients with NSCLC was conducted to determine the risk factors associated with PPC after lung cancer surgery. The preoperative evaluation demonstrated a lower predicted DLCO in the COPD group compared to non-COPD counterparts. Univariate analysis found that patients with COPD who went on to develop a PPC had a lower percentage of predicted DLCO of 86% compared to 93.1% in patients who did not develop PPC. Moreover, in the non-COPD group, predicted DLCO was 87.7% in patients who developed a PPC compared with 96.7% in patients who did not develop a PPC. This study signifies low DLCO as a vital risk factor for postoperative complications in both COPD and non-COPD groups thus highlighting the importance of measuring DLCO in patients with normal spirometry prior to resection for NSCLC [DLCO was also found to be a significant prognostic factor following surgical resection for stage I NSCLC. In a study, 426 patients who underwent resection for stage I NSCLC were recruited to investigate the short and long-term outcomes in those with a 'marginal-risk' versus 'normal-risk'. Marginal-risk was defined as a ppoFEV1 of 30-60% and/or ppoDLCO of 30-60%; while, normal-risk was defined as ppoFEV1 \u2265 60% and ppoDLCO \u2265 60%.\u00a0After applying exclusion criteria, 391 patients were included with 73 classified as marginal-risk and 318 as normal-risk. Overall, marginal-risk patients compared to normal-risk had higher postoperative morbidity (48% vs 21% respectively), pulmonary complications (34% vs 11%) and prolonged hospital stay (23% vs 6%).\u00a0Among six patients with a ppoFEV1 and/or ppoDLCO of <40%, postoperative morbidity was found to be 83%. Furthermore, in the 27 patients with a ppoFEV1 and/or ppoDLCO of <50%, postoperative morbidity occurred in 44%, PPC occurred in 33% and 22% had longer hospital stays .\u00a0Cardiopulmonary exercise testing (CPET)\u00a0Cardiopulmonary exercise testing (CPET) is a complex, non-invasive approach to cardiorespiratory evaluation during exercise and at rest under controlled physiological conditions . Of lateVO2 peak is the maximum value of oxygen uptake measured during CPET at the end of the exercise phase . It is tAnaerobic/ lactate threshold (AT) is a measure of submaximal exercise capacity, i.e. oxygen consumption achieved almost exclusively under aerobic conditions . Since iVE/VCO2 is not only a ratio of the minute ventilation to CO2 output but also an expression of gas exchange efficiency . ElevateCardiac and thoracic risk indicesAs cardiovascular complications are potential risks following lung cancer resection, a cardiovascular risk assessment must be performed preoperatively . The NatThoracic Revised Cardiac Risk IndexThe Revised Cardiac Risk Index (RCRI) was proposed in 1999 by Lee et al. for evaluation of stable non-urgent major non-cardiac surgery patients . This waThe sum of these scores then divides patients into different risk classes that estimate their risk of cardiac complications, thus determining those who require further cardiac assessments: (1) Class A - 0 points (1.5%), (2) Class B - 1-1.5 points (5.8%), (3) Class C - 2-2.5 points (19%) (4) Class D - >2.5 points (23%).The validity of the ThRCRI in predicting cardiovascular risk after major lung resection has been supported in multiple studies -20 ,\u00a0which specifically looks at in-hospital mortality following general thoracic surgery. The nine variables it uses include age , sex, American Society of Anesthesiologists (ASA) score , Zubrod score , dyspnea score , the priority of surgery  and procedure class  . NICE reThoracoscore and the modified Thoracoscore (dyspnea score excluded) have previously been externally validated, including a retrospective study in which 1675 patients who underwent thoracic surgery (n=626 for lung resections) were analyzed from 2002 to 2006. The modified Thoracoscore proved to be an effective predictor of in-hospital mortality and midterm mortality (mean follow-up of 25 months), with in-hospital mortality risk increasing by 20% for every 1% increase of the modified Thoracoscore, and midterm mortality increasing by 12% for every 1% increase  Table 33.However, studies in recent years have shown the inaccuracy of Thoracoscore, particularly when compared to other models. One such study aimed to externally validate Thoracoscore, as well as other multivariable prediction models , looking at their effectiveness in estimating perioperative mortality. The survival time (number of days from surgery to date of death) was measured in 6600 patients who underwent lung resection between 2012 and 2018. Each model was produced to predict either in-hospital or perioperative mortality; 5/6 of the models had an inaccurate estimation of the type of mortality they were made for, with the modified Eurolung model producing the only acceptable prediction (observed:expected ratio of 0.92). However, this model has limited variables and does not factor in patient comorbidities, thereby bringing its clinical validity into question .A brief summary of some of the available risk models in thoracic surgery along with their disadvantages is mentioned in the table below -28 Tabl. Their uFrailty\u00a0Frailty assessment is defined as an age-related decline in multiple physiological systems and can be used to flag vulnerable patients who may benefit from pre-operative rehab or non-surgical therapies . The curmFI was formed by matching the Canadian Study of Health and Aging Frailty index (CSHA-FI) to the 11 variables, for example, MI history and diabetes, compiled by the American College of Surgeons NSQIP . RCRI usA study on frailty assessment was conducted at a single-site thoracic surgical clinic - out of the 180 eligible patients, 125 completed screening. Results showed that 71 (57%) were prefrail and 15 (12%) were frail . This isPreoperative risk assessments for lung cancer resection play a vital role in determining whether it is appropriate to operate, deciding if further assessments or treatments are required, and predicting a patient\u2019s prognosis. Some of these assessments, such as a frailty assessment, CPET and ThRCRI, have been externally validated by studies, proving their accuracy in predicting complications. Their use in combination, depending on the patient, would provide a detailed picture of what a patient\u2019s outcome following surgery would be. However, other assessments, such as pulmonary function tests and Thoracoscore, still have conflicting evidence regarding their efficacy. This is possibly skewed by small underpowered studies, hence need for larger studies using acceptable cut off values. These assessments require further external validation, and should not, at this time, replace the use of the assessments that have proven to be effective.", "texts": ["A comprehensive review of\u00a0relevant clinical literature on evidence-based recommendations and existing prediction models specific to lung cancer surgery was undertaken. Preoperative risk assessment parameters such as pulmonary function tests (PFT), cardiopulmonary exercise testing (CPET), Brunelli models, Thoracoscore and frailty were analyzed for\u00a0predicting postoperative risk of complications.\u00a0(DLCO ) showed conflicting evidence in determining a positive correlation with postoperative mortality. CPET variables predicted higher complication risk when\u00a0VO2peak < 10ml/kg/min, AT < 11ml/kg/min and ventilation/carbon dioxide production (VE/VCO2) was in range of 34-40. While a cardiac risk index like the Thoracic Revised Cardiac Risk Index (ThRCRI) predicted major cardiovascular compromise, a\u00a0thoracic risk index like Thoracoscore proved imprecise. Lastly, frailty is used to risk stratify patients in clinical practice but a recognized validated model specific to thoracic surgery is non-existent.When assessing fitness for surgery, the primarily used PFT parameters such as predictive postoperative forced expiratory volume in one second (FEV1) and diffusion capacity for carbon monoxideWhen considering patients for lung cancer surgery, some dilemma exists regarding the accuracy of clinical prediction models and their external validation. There is a pressing need for the development of a consolidated clinically robust risk stratification model to predict complications after thoracic resections. Lung cancer is the leading cause of oncological deaths worldwide .\u00a0It is aTreatment of early-stage lung cancer primarily involves surgical resection as it delivers a strong probability of cure . DespiteThis highlights the need to risk stratify to predict mortality, morbidity and long-term shortness of breath in lung cancer patients.\u00a0In the last decade, an increasing amount of literature has addressed the role of various parameters used in preoperative risk assessment. This often involves cardiorespiratory evaluation in conjunction with assessment of operative mortality, lung function and exercise testing. More recently, there has been an emphasis on frailty as a significant surgical risk factor and practical screening tool.\u00a0Individual preoperative investigations such as pulmonary function tests (PFT), cardiopulmonary exercise testing (CPET), Brunelli models, Thoracoscore and frailty can be useful in clinical practice and the accuracy of these in predicting postoperative risk has been analyzed in this article.\u00a0Pulmonary function testsppoFEV1Assessment of pulmonary function parameters such as forced expiratory volume in one second\u00a0(FEV1) and predicted postoperative FEV1 (ppoFEV1) is important in-patient selection for lung cancer surgery. This is to evaluate the possibility of postoperative pulmonary complications (PPC)\u00a0and operative mortality, defined as death within 30 days of surgery. Patients with an estimated ppoFEV1>40% are considered as having an average risk, and high risk is determined by an estimated ppoFEV1 <40% [Various small studies have been carried out at local or regional units to establish the risk indicators for developing PPC. A four-year prospective observational study of 285 patients undergoing video-assisted thoracoscopic surgery (VATS) for non-small cell lung cancer (NSCLC) was carried out. Data on gender, age, predicted %FEV1, ASA score, perioperative activity level, BMI, smoking status, and NSCLC staging were recorded. Of the 21 participants who went on to develop postoperative pulmonary complications, the percentage of predicted FEV1 was 88.8% compared with 87.5% in patients who did not develop complications. Predicted %FEV1 was not found to be a significant independent risk factor in determining PPC such as pneumonia, atelectasis, longer hospital stays in high-dependency units or admission to intensive care following VATS   and %FEV1 was collected. A cut-off value of 70% for FEV1 was defined as obstructive ventilatory impairment. In Japan, FEV1\u00a0of less than 70% is defined as obstructive ventilatory impairment which is in contrast to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification. Postoperative complications were present in 35% of patients with a %FEV1 <70% compared to 23% of patients with an FEV1 \u226570%.\u00a0Univariate analysis showed that FEV1 <70% was associated with a greater risk of postoperative atelectasis, pneumonia, and air leakage. These findings oppose the aforementioned studies likely due to the larger population size and demonstrate %FEV1 as an important predictor and significant risk factor of postoperative complications [Moreover, a study using whole lung CT to determine preoperative pulmonary function was carried out in 390 patients who underwent resection for lung cancer. The development cohort had 290 patients and 100 patients formed the validation cohort. Whole lung CT along with patient demographics was used to develop a regression equation for FEV1 to determine preoperative pulmonary function and ppoFEV1. The ppoFEV1 was also calculated based on the anatomic equation: measured %FEV1 x (42 - number of subsegments resected)/42. Both regression analysis and actual measured FEV1/FVC, %FEV1 and %ppoFEV1 were shown to be significant variables associated with predicting postoperative cardiopulmonary complications in both cohorts. Both calculated ppoFEV1 and actual ppoFEV1 were positively correlated with the occurrence of PPC . The useTaking these studies into account, pulmonary function parameters continue to provide conflicting evidence for their ability to predict postoperative complications. The smaller population size of these studies is a limiting factor and we need stronger studies collaborated at national or international units to improve reliabilityDiffusion capacity for carbon monoxide (DLCO)In addition to spirometric parameters, the diffusion capacity for carbon monoxide (DLCO), also known as the transfer factor for carbon monoxide (TLCO), is considered in most preoperative assessments in addition to ppoFEV1. DLCO is based on the ability of carbon monoxide to bind to haemoglobin, therefore DLCO represents the efficiency of gas transfer from inspired air into red blood cells. A low DLCO predicts (a) a higher likelihood of pulmonary complications requiring either supplemental oxygen or hospitalization and (b) a worse dyspnea score. DLCO is also strongly associated with the risk of higher operative mortality . DLCO isA prospective study involving 351 patients with NSCLC was conducted to determine the risk factors associated with PPC after lung cancer surgery. The preoperative evaluation demonstrated a lower predicted DLCO in the COPD group compared to non-COPD counterparts. Univariate analysis found that patients with COPD who went on to develop a PPC had a lower percentage of predicted DLCO of 86% compared to 93.1% in patients who did not develop PPC. Moreover, in the non-COPD group, predicted DLCO was 87.7% in patients who developed a PPC compared with 96.7% in patients who did not develop a PPC. This study signifies low DLCO as a vital risk factor for postoperative complications in both COPD and non-COPD groups thus highlighting the importance of measuring DLCO in patients with normal spirometry prior to resection for NSCLC [DLCO was also found to be a significant prognostic factor following surgical resection for stage I NSCLC. In a study, 426 patients who underwent resection for stage I NSCLC were recruited to investigate the short and long-term outcomes in those with a 'marginal-risk' versus 'normal-risk'. Marginal-risk was defined as a ppoFEV1 of 30-60% and/or ppoDLCO of 30-60%; while, normal-risk was defined as ppoFEV1 \u2265 60% and ppoDLCO \u2265 60%.\u00a0After applying exclusion criteria, 391 patients were included with 73 classified as marginal-risk and 318 as normal-risk. Overall, marginal-risk patients compared to normal-risk had higher postoperative morbidity (48% vs 21% respectively), pulmonary complications (34% vs 11%) and prolonged hospital stay (23% vs 6%).\u00a0Among six patients with a ppoFEV1 and/or ppoDLCO of <40%, postoperative morbidity was found to be 83%. Furthermore, in the 27 patients with a ppoFEV1 and/or ppoDLCO of <50%, postoperative morbidity occurred in 44%, PPC occurred in 33% and 22% had longer hospital stays .\u00a0Cardiopulmonary exercise testing (CPET)\u00a0Cardiopulmonary exercise testing (CPET) is a complex, non-invasive approach to cardiorespiratory evaluation during exercise and at rest under controlled physiological conditions . Of lateVO2 peak is the maximum value of oxygen uptake measured during CPET at the end of the exercise phase . It is tAnaerobic/ lactate threshold (AT) is a measure of submaximal exercise capacity, i.e. oxygen consumption achieved almost exclusively under aerobic conditions . Since iVE/VCO2 is not only a ratio of the minute ventilation to CO2 output but also an expression of gas exchange efficiency . ElevateCardiac and thoracic risk indicesAs cardiovascular complications are potential risks following lung cancer resection, a cardiovascular risk assessment must be performed preoperatively . The NatThoracic Revised Cardiac Risk IndexThe Revised Cardiac Risk Index (RCRI) was proposed in 1999 by Lee et al. for evaluation of stable non-urgent major non-cardiac surgery patients . This waThe sum of these scores then divides patients into different risk classes that estimate their risk of cardiac complications, thus determining those who require further cardiac assessments: (1) Class A - 0 points (1.5%), (2) Class B - 1-1.5 points (5.8%), (3) Class C - 2-2.5 points (19%) (4) Class D - >2.5 points (23%).The validity of the ThRCRI in predicting cardiovascular risk after major lung resection has been supported in multiple studies -20 ,\u00a0which specifically looks at in-hospital mortality following general thoracic surgery. The nine variables it uses include age , sex, American Society of Anesthesiologists (ASA) score , Zubrod score , dyspnea score , the priority of surgery  and procedure class  . NICE reThoracoscore and the modified Thoracoscore (dyspnea score excluded) have previously been externally validated, including a retrospective study in which 1675 patients who underwent thoracic surgery (n=626 for lung resections) were analyzed from 2002 to 2006. The modified Thoracoscore proved to be an effective predictor of in-hospital mortality and midterm mortality (mean follow-up of 25 months), with in-hospital mortality risk increasing by 20% for every 1% increase of the modified Thoracoscore, and midterm mortality increasing by 12% for every 1% increase  Table 33.However, studies in recent years have shown the inaccuracy of Thoracoscore, particularly when compared to other models. One such study aimed to externally validate Thoracoscore, as well as other multivariable prediction models , looking at their effectiveness in estimating perioperative mortality. The survival time (number of days from surgery to date of death) was measured in 6600 patients who underwent lung resection between 2012 and 2018. Each model was produced to predict either in-hospital or perioperative mortality; 5/6 of the models had an inaccurate estimation of the type of mortality they were made for, with the modified Eurolung model producing the only acceptable prediction (observed:expected ratio of 0.92). However, this model has limited variables and does not factor in patient comorbidities, thereby bringing its clinical validity into question .A brief summary of some of the available risk models in thoracic surgery along with their disadvantages is mentioned in the table below -28 Tabl. Their uFrailty\u00a0Frailty assessment is defined as an age-related decline in multiple physiological systems and can be used to flag vulnerable patients who may benefit from pre-operative rehab or non-surgical therapies . The curmFI was formed by matching the Canadian Study of Health and Aging Frailty index (CSHA-FI) to the 11 variables, for example, MI history and diabetes, compiled by the American College of Surgeons NSQIP . RCRI usA study on frailty assessment was conducted at a single-site thoracic surgical clinic - out of the 180 eligible patients, 125 completed screening. Results showed that 71 (57%) were prefrail and 15 (12%) were frail . This isPreoperative risk assessments for lung cancer resection play a vital role in determining whether it is appropriate to operate, deciding if further assessments or treatments are required, and predicting a patient\u2019s prognosis. Some of these assessments, such as a frailty assessment, CPET and ThRCRI, have been externally validated by studies, proving their accuracy in predicting complications. Their use in combination, depending on the patient, would provide a detailed picture of what a patient\u2019s outcome following surgery would be. However, other assessments, such as pulmonary function tests and Thoracoscore, still have conflicting evidence regarding their efficacy. This is possibly skewed by small underpowered studies, hence need for larger studies using acceptable cut off values. These assessments require further external validation, and should not, at this time, replace the use of the assessments that have proven to be effective."]}
{"representative": "The Phosphohistone H3 (PHH3) antibody is recognized as a biomarker of cell proliferation, specific for cells in mitosis, of prognostic value in different malignant neoplasms, however it has been poorly studied in oral squamous cell carcinoma (OSCC). The main objective of this study was to evaluate the immunoexpression of the PHH3 in the OSCC, through the correlation with the immunoexpression of Ki-67, the mitotic activity index (MAI), histological grading, clinical-morphological parameters and the rate of survival. The study sample consisted of 62 cases of OSCC diagnosed in the Pathological Anatomy Laboratory of the Faculty of Dentistry, University of the Republic (Uruguay). In each of them, an immunohistochemical technique was performed for Ki-67 and PHH3 (serine 10) antibodies. Image J software was used for the MAI and biomarker quantification, defining the percentage of positivity and mitotic Figures per 1000 tumor cells.p 0.016) and MAI (p 0.031) with survival time. However, no similar relationship was found with Ki-67 (p 0.295). Although it was confirmed a statistical association between histological grade and Ki-67 immunoexpression (p 0.004), PHH3 did not show a similar relationship (p 0.564). a significant association was obtained between the expression of PHH3 ( It was confirmed the role of the PHH3 antibody as a biomarker of mitotic Figures in OSCC and as a potential marker of cell proliferation. It is noteworthy that this is one of the first works that evaluates a possible relationship between the expression of this antibody and survival in OSCC. Key words:Oral squamous cell carcinoma, phosphohistone H3, Ki-67, cell proliferation. Oral squamous cell carcinoma (OSCC) represents the most common cancer of head and neck region ,2. It isCell proliferation is an essential biological process, key in the growth and maintenance of tissue homeostasis, whose loss of control plays a fundamental role in the development of malignant neoplasms ,6. In faMAI represents the oldest method for determining the proliferative capacity of malignant neoplasms ,11. It iThe PHH3 antibody is recognized as a biomarker of cell proliferation, specific for cells in mitosis, by identifying phosphorylated histone H3 by IHC ,11,16. HThe main objective of this study was to evaluate the immunoexpression of PHH3 in OSCC, through the correlation with the immunoexpression of Ki-67, MAI, histological grading, clinical-morphological parameters and the rate of survival.The study sample consisted of 62 cases of OSCC, corresponding mostly to incisional biopsies diagnosed in the Pathological Anatomy Laboratory of the University of the Republic (UdelaR) School of Dentistry, in the period 2007-2015. The clinical\u2011pathological records of each of the cases were reviewed, recording the variables corresponding to gender, age, topography, date of pathological diagnosis and histopathological diagnosis. Survival was defined as the time elapsed between the initial histopathological diagnosis and death from cancer. The histopathological diagnosis of each of the cases was made according to the WHO classification (2017) for OSCC, in well, moderately and poorly differentiated  and IHC histological slides were digitized with the Motic VM 3.0 Digital Slide Scanning System for image acquisition and processing. Motic VM 3.0 Motic Digital Slide Assistant software  was used for its analysis. Cell quantification was performed with the Image J software manual counting tool . For the calculation of the MAI, in the H-E slides, normal and atypical MF present in 1000 tumor cells were counted. The identification of the MF was carried out according to the morphological characteristics described by Van Diest anaphase .Immunohistochemical processing: from the blocks of tissue fixed in formalin and embedded in paraffin, two sections of 4 \u03bcm thickness were obtained. To unmask the antigenic epitopes, recovery was performed with sodium citrate solution (pH 6.2)  in a microwave pressure cooker at maximum power for about 5 minutes. Endogenous peroxidases were blocked with 0.9 % hydrogen peroxide for 5 minutes. Tissue sections were incubated with the primary antibodies Ki\u201167  and PHH3 (Serine 10)  for about 45 minutes and then with a biotinylated anti-mouse/anti-rabbit secondary antibody for 30 minutes. To visualize the products of the antigen-antibody reaction, 3,3' diaminobenzidine H2O2  was used, followed by counterstaining with Harris hematoxylin . Breast carcinoma samples were used as a positive control for IHC processing. Likewise, as a negative control, IHC processing was performed omitting the incubation step with the primary antibodies.IHC evaluation: positive cells for the Ki-67 antibody were considered to be those neoplastic epithelial cells that presented a brown nucleus, regardless of the intensity and pattern of staining ,9,22. FoPrior to the IHC evaluation, interobserver calibration was performed between two pathologists, who previously agreed on the morphological criteria necessary for the identification of MF and positive cells for biomarkers. The observers carried out their quantifications independently, without knowing the Figures established by each other. The interclass correlation coefficient (ICC) was used to calculate the degree of interobserver agreement .Statistical analysis: in the considered markers comparation, descriptive statistics (mean and standard deviation) were used for categorical variables, and frequency distribution for continuous variables. To compare the expression of the markers according to sex, age, location and histological grade, when it came to two groups, the comparison of means based on the student's t-test for independent samples was used. Likewise, in cases where three or more groups were compared, the analysis of variance (ANOVA) model was used. In cases where a significant association was identified, multiple comparisons were carried out considering the Tukey test. Additionally, scatter diagrams were made to investigate the degree of linear correlation between the three markers, calculating in each case, the Pearson linear correlation coefficient. Survival analysis was carried out using the Kaplan-Meier survival curves. The association of patient survival was analyzed according to the three markers considered, in a multivariate analysis through the Cox proportional hazards model, adjusting the results by sex, age, grouped location and histological grade. While their comparisons were made using the Cox model. All tests were carried out with a significance level of 5%.- Descriptive analysis of the clinical-pathological variables of OSCC: of the 62 cases, the 64.6% corresponded to men and the 59.7% were older than 65 years, the 43.5% were located in others , 25.8 % in tongue, 21.0 % in palate and 9.7 % in the mouth\u00b4s floor. Regarding histological grading, 61.3 % corresponded to moderately differentiated OSCC (Grade 2), 27.4 % to well-differentiated OSCC (Grade 1), and only 1.3 % were classified as poorly differentiated OSCC (Grade 3) .p 0.004) (p 0.564). Neither could a statistically significant correlation be demonstrated between the biomarkers studied and the independent variables, sex, age and location  . Thus, ilocation .p 0.041)     and the survival rate at five years was 27 %  Fig. . Likewis16) Fig. . A signip 0.194)  Fig. . In contThe evaluation of cell proliferation in cancer is considered an important histological parameter for defining the biological behavior of the tumor and for determining the individualized prognosis for each patient . Howeverp 0.295). Along the same lines, the results obtained by Brockton et al. and Gonzales Moles et al. . Although it was previously established in invasive breast and urogenital cancer, it wasn\u00b4t found any work in the literature that had previously studied this relationship in OSCC ; expected since both are biomarkers of cell proliferation expressed by the fraction of cells that are actively passing through the cell cycle. This association was described in breast cancer by Kim et al. and in follicular lymphoma by Bedekovics et al.(p 0.004), which supports the potential usefulness of this biomarker in the histopathological classification of OSCC , expected because the PHH3 antibody is a specific IHC biomarker of MF and because it was used the same quantification criteria, both in the H-E slides for MAI and in those for IHC (When compared the immunostaining patterns of the studied biomarkers, in the Ki-67 slides, nuclear immunostaining was shown with a wide range of intensities, a factor that contributes to low reproducibility -11,29. O for IHC ,19,21.The main limitations of the study are the sample size, not including the tumor invasion front as an evaluation parameter because most of the biopsies were incisional, and not having the TNM stage of the cases analyzed.The PHH3, is a biomarker of cell proliferation specific to cells in mitosis, with respect to Ki-67, has been underinvestigated in the literature. In this work, a significant relationship was demonstrated between the immunoexpression of the phh3 and the survival of patients with OSCC. A significant association of MAI with survival time was also observed. Regarding the Ki-67, as was previously described in the literature, a positive association was confirmed between the degree of histological differentiation of the OSCC and the marker\u00b4s positive immunoexpression. Based on the results obtained, it is important to continue investigating the PHH3 proliferation biomarker in OSCC, with a uniformly standardized IHC protocol and in a large cohort of cases.", "texts": ["The Phosphohistone H3 (PHH3) antibody is recognized as a biomarker of cell proliferation, specific for cells in mitosis, of prognostic value in different malignant neoplasms, however it has been poorly studied in oral squamous cell carcinoma (OSCC). The main objective of this study was to evaluate the immunoexpression of the PHH3 in the OSCC, through the correlation with the immunoexpression of Ki-67, the mitotic activity index (MAI), histological grading, clinical-morphological parameters and the rate of survival. The study sample consisted of 62 cases of OSCC diagnosed in the Pathological Anatomy Laboratory of the Faculty of Dentistry, University of the Republic (Uruguay). In each of them, an immunohistochemical technique was performed for Ki-67 and PHH3 (serine 10) antibodies. Image J software was used for the MAI and biomarker quantification, defining the percentage of positivity and mitotic Figures per 1000 tumor cells.p 0.016) and MAI (p 0.031) with survival time. However, no similar relationship was found with Ki-67 (p 0.295). Although it was confirmed a statistical association between histological grade and Ki-67 immunoexpression (p 0.004), PHH3 did not show a similar relationship (p 0.564). a significant association was obtained between the expression of PHH3 ( It was confirmed the role of the PHH3 antibody as a biomarker of mitotic Figures in OSCC and as a potential marker of cell proliferation. It is noteworthy that this is one of the first works that evaluates a possible relationship between the expression of this antibody and survival in OSCC. Key words:Oral squamous cell carcinoma, phosphohistone H3, Ki-67, cell proliferation. Oral squamous cell carcinoma (OSCC) represents the most common cancer of head and neck region ,2. It isCell proliferation is an essential biological process, key in the growth and maintenance of tissue homeostasis, whose loss of control plays a fundamental role in the development of malignant neoplasms ,6. In faMAI represents the oldest method for determining the proliferative capacity of malignant neoplasms ,11. It iThe PHH3 antibody is recognized as a biomarker of cell proliferation, specific for cells in mitosis, by identifying phosphorylated histone H3 by IHC ,11,16. HThe main objective of this study was to evaluate the immunoexpression of PHH3 in OSCC, through the correlation with the immunoexpression of Ki-67, MAI, histological grading, clinical-morphological parameters and the rate of survival.The study sample consisted of 62 cases of OSCC, corresponding mostly to incisional biopsies diagnosed in the Pathological Anatomy Laboratory of the University of the Republic (UdelaR) School of Dentistry, in the period 2007-2015. The clinical\u2011pathological records of each of the cases were reviewed, recording the variables corresponding to gender, age, topography, date of pathological diagnosis and histopathological diagnosis. Survival was defined as the time elapsed between the initial histopathological diagnosis and death from cancer. The histopathological diagnosis of each of the cases was made according to the WHO classification (2017) for OSCC, in well, moderately and poorly differentiated  and IHC histological slides were digitized with the Motic VM 3.0 Digital Slide Scanning System for image acquisition and processing. Motic VM 3.0 Motic Digital Slide Assistant software  was used for its analysis. Cell quantification was performed with the Image J software manual counting tool . For the calculation of the MAI, in the H-E slides, normal and atypical MF present in 1000 tumor cells were counted. The identification of the MF was carried out according to the morphological characteristics described by Van Diest anaphase .Immunohistochemical processing: from the blocks of tissue fixed in formalin and embedded in paraffin, two sections of 4 \u03bcm thickness were obtained. To unmask the antigenic epitopes, recovery was performed with sodium citrate solution (pH 6.2)  in a microwave pressure cooker at maximum power for about 5 minutes. Endogenous peroxidases were blocked with 0.9 % hydrogen peroxide for 5 minutes. Tissue sections were incubated with the primary antibodies Ki\u201167  and PHH3 (Serine 10)  for about 45 minutes and then with a biotinylated anti-mouse/anti-rabbit secondary antibody for 30 minutes. To visualize the products of the antigen-antibody reaction, 3,3' diaminobenzidine H2O2  was used, followed by counterstaining with Harris hematoxylin . Breast carcinoma samples were used as a positive control for IHC processing. Likewise, as a negative control, IHC processing was performed omitting the incubation step with the primary antibodies.IHC evaluation: positive cells for the Ki-67 antibody were considered to be those neoplastic epithelial cells that presented a brown nucleus, regardless of the intensity and pattern of staining ,9,22. FoPrior to the IHC evaluation, interobserver calibration was performed between two pathologists, who previously agreed on the morphological criteria necessary for the identification of MF and positive cells for biomarkers. The observers carried out their quantifications independently, without knowing the Figures established by each other. The interclass correlation coefficient (ICC) was used to calculate the degree of interobserver agreement .Statistical analysis: in the considered markers comparation, descriptive statistics (mean and standard deviation) were used for categorical variables, and frequency distribution for continuous variables. To compare the expression of the markers according to sex, age, location and histological grade, when it came to two groups, the comparison of means based on the student's t-test for independent samples was used. Likewise, in cases where three or more groups were compared, the analysis of variance (ANOVA) model was used. In cases where a significant association was identified, multiple comparisons were carried out considering the Tukey test. Additionally, scatter diagrams were made to investigate the degree of linear correlation between the three markers, calculating in each case, the Pearson linear correlation coefficient. Survival analysis was carried out using the Kaplan-Meier survival curves. The association of patient survival was analyzed according to the three markers considered, in a multivariate analysis through the Cox proportional hazards model, adjusting the results by sex, age, grouped location and histological grade. While their comparisons were made using the Cox model. All tests were carried out with a significance level of 5%.- Descriptive analysis of the clinical-pathological variables of OSCC: of the 62 cases, the 64.6% corresponded to men and the 59.7% were older than 65 years, the 43.5% were located in others , 25.8 % in tongue, 21.0 % in palate and 9.7 % in the mouth\u00b4s floor. Regarding histological grading, 61.3 % corresponded to moderately differentiated OSCC (Grade 2), 27.4 % to well-differentiated OSCC (Grade 1), and only 1.3 % were classified as poorly differentiated OSCC (Grade 3) .p 0.004) (p 0.564). Neither could a statistically significant correlation be demonstrated between the biomarkers studied and the independent variables, sex, age and location  . Thus, ilocation .p 0.041)     and the survival rate at five years was 27 %  Fig. . Likewis16) Fig. . A signip 0.194)  Fig. . In contThe evaluation of cell proliferation in cancer is considered an important histological parameter for defining the biological behavior of the tumor and for determining the individualized prognosis for each patient . Howeverp 0.295). Along the same lines, the results obtained by Brockton et al. and Gonzales Moles et al. . Although it was previously established in invasive breast and urogenital cancer, it wasn\u00b4t found any work in the literature that had previously studied this relationship in OSCC ; expected since both are biomarkers of cell proliferation expressed by the fraction of cells that are actively passing through the cell cycle. This association was described in breast cancer by Kim et al. and in follicular lymphoma by Bedekovics et al.(p 0.004), which supports the potential usefulness of this biomarker in the histopathological classification of OSCC , expected because the PHH3 antibody is a specific IHC biomarker of MF and because it was used the same quantification criteria, both in the H-E slides for MAI and in those for IHC (When compared the immunostaining patterns of the studied biomarkers, in the Ki-67 slides, nuclear immunostaining was shown with a wide range of intensities, a factor that contributes to low reproducibility -11,29. O for IHC ,19,21.The main limitations of the study are the sample size, not including the tumor invasion front as an evaluation parameter because most of the biopsies were incisional, and not having the TNM stage of the cases analyzed.The PHH3, is a biomarker of cell proliferation specific to cells in mitosis, with respect to Ki-67, has been underinvestigated in the literature. In this work, a significant relationship was demonstrated between the immunoexpression of the phh3 and the survival of patients with OSCC. A significant association of MAI with survival time was also observed. Regarding the Ki-67, as was previously described in the literature, a positive association was confirmed between the degree of histological differentiation of the OSCC and the marker\u00b4s positive immunoexpression. Based on the results obtained, it is important to continue investigating the PHH3 proliferation biomarker in OSCC, with a uniformly standardized IHC protocol and in a large cohort of cases."]}
{"representative": "Although neoadjuvant therapy (Nac) is recommended for high-risk resectable pancreatic cancer (R-PDAC), evidence regarding specific regimes is scarce. This report aimed to investigate the efficacy of S-1 Nac for R-PDAC. In a multicenter phase II trial, we investigated the efficacy of Nac S-1  in R-PDAC patients. The protocol involved two cycles of preoperative S-1 chemotherapy, followed by surgery, and four cycles of postoperative S-1 chemotherapy. Two-year progression-free survival (PFS) rates were the primary endpoint. Overall survival (OS) rates and median survival time (MST) were secondary endpoints. Forty-nine patients were eligible, and 31 patients underwent resection following Nac, as per protocol . Per-protocol analysis included data from 31 patients, yielding the 2-year PFS rate of 58.1%, and 2-, 3-, and 5-year OS rates of 96.8%, 54.8%, and 44.0%, respectively. MST was 49.2\u00a0months. Intention-to-treat analysis involved 49 patients, yielding the 2-year PFS rate of 40.8%, and the 2-, 3-, and 5-year OS rates of 87.8%, 46.9%, and 33.9%, respectively. MST was 35.5\u00a0months. S-1 single regimen might be an option for Nac in R-PDAC; however, the high drop-out rate (36.7%) was a limitation of this study. However, evidence regarding specific regimens for Nac in R-PDAC is scarce, and participation in clinical trials is encouraged. A recent meta-analysis reported that the median overall survival (OS) of R-PDAC ranged from 12 to 25.3\u00a0months in upfront surgery, while the median OS associated with Nac group ranged from 10 to 50.2\u00a0months2. A separate meta-analysis based on intention-to-treat analyses has shown that patients with PDAC who received Nac had better long-term survival outcomes than patients who received upfront surgery 3. In a large-scale propensity-score matched analysis, Nac with upfront surgery was associated with improved survival 4. At present, at least eight randomized trials have investigated the use of Nac for R-PDAC. However, only two trials have reported long-term outcomes associated with preoperative treatment6. One of the trials was PREOPANC trial that showed survival benefit of preoperative chemoradiotherapy using gemcitabine with radiation 5. The other trial was Prep-02/JSAP-05 trial that showed survival benefit of Nac using gemcitabine with S-1 6. Thus, there is sparse evidence with respect to the administration of Nac for R-PDAC and the optimal protocol.The National Comprehensive Cancer Network (NCCN) guidelines recommend upfront surgery for patients with resectable pancreatic ductal adenocarcinoma (R-PDAC) , or neoadjuvant therapy (Nac) is also recommended for high-risk R-PDAC cases, such as those involving high levels of tumor marker, large primary tumors, weight loss, and so on9. As such, the main purpose of Nac in the treatment of R-PDAC is the prevention of postoperative recurrence, which is consistent with postoperative adjuvant therapy. Preoperative treatment of R-PDAC does not need to reduce tumor size, as even if the local effect is weak, R0 resection is possible in cases of stable disease.The theoretical benefits of neoadjuvant therapy in R-PDAC are (a) early treatment of potentially metastatic disease, (b) identification of patients diagnosed with metastatic disease during treatment who can be spared surgical procedures that are unlikely to have survival benefit, and (c) delivery of chemotherapy and radiation to the primary tumor while it is in an intact, well-vascularized condition. In cases of R-PDAC, downsizing strategies to improve R0 resectability are not as important as they are in cases of borderline resectable PDAC or locally advanced PDAC. It should be noted that early treatment of potentially metastatic disease involves the same strategy as postoperative adjuvant therapy; however, only approximately 60% of patients with PDAC receive postoperative adjuvant therapy in the real world setting due to perioperative morbidity or early disease recurrenceP\u2009<\u20090.0001)10. In the same trial, disease recurrence in the liver was observed in 29% of patients in the Gem group and in 19% of patients in the S-1 group (P\u2009=\u20090.0016). Based on these findings, we hypothesized that S-1 might decrease the risk of micrometastasis, such as occult liver metastasis, in cases of R-PDAC. We conducted a multicenter single-arm phase II clinical trial to investigate the efficacy of S-1 Nac in patients with R-PDAC. This study is the first trial to focus on the prevention of R-PDAC recurrence using only a single oral agent for preoperative treatment.Given the advantages of Nac, S-1  was selected for use in the present study; this regimen has been associated with relatively good outcomes as postoperative adjuvant therapy. The JASPAC01 trial has shown that the S-1 regimen is a superior adjuvant therapy to gemcitabine (Gem) in patients with R-PDAC  findings, under the informed consent. We enrolled 49 patients in this trial between January 2014 and October 2015. The CONSORT study flow summary is presented in Fig.\u00a0Treatment-related adverse events (AEs) are shown in Table After completing Nac, 33 patients proceeded to surgery Fig.\u00a0. ConcurrThe postoperative complications after pancreatectomy are shown in Table Of 31 patients who completed Nac followed by R0/R1 resection, 28 (90.3%) started S-1 adjuvant therapy and three patients did not (2 patients had poor performance status (PS) and one patient had bone metastasis before adjuvant therapy). Twenty-two patients completed all pre- and postoperative therapies as per study protocol (45% of 49 eligible patients and 71% of completed Nac patients). Meanwhile, among 12 patients who discontinued Nac, but received R0/R1 resection, 8 (66.7%) patients started adjuvant therapy and six patients completed it. Another four patients refused any chemotherapy.The 2-year progression-free survival (PFS) rate was 58.1% in 31 patients who completed Nac (per-protocol) followed by R0/R1 resection, and 40.8% in the intension-to-treat (ITT) analysis that included all 49 eligible patients  was 35.5\u00a0months. The observed 2-, 3-, and 5-year OS rates for per-protocol patients (n\u2009=\u200931) were 80.7%, 54.8%, and 44.0%, respectively, and the MST was 49.2\u00a0months. The 2-, 3-, and 5-year OS rates for off-protocol patients (n\u2009=\u200918) were 55.6%, 38.9%, and 11.1%, respectively, and the MST was 27.6\u00a0months  are shown in Supplemental Table Se3. Of the per-protocol (Nac complete) resection patients (n\u2009=\u200931), 18 (58.1%) patients experienced disease recurrence; this rate was lower than that of the off-protocol (Nac failure) resections . The rate of distant metastasis was high among off-protocol resections (75% vs. 48.3%). Liver recurrence (disease progression) for per-protocol resections, off-protocol resections, and non-resection was found in 25.8%, 33.3%, and 50% of cases, respectively.3. In fact, the present study subpopulation that met the JASPAC01 trial criteria showed relatively better survival . A recent meta-analysis, including 18 studies that involved 857 patients, has reported that the MST associated with Nac for patients with R-PDAC was 18.2\u00a0months (range: 10\u201350.2\u00a0months)2. In our trial, the MST of all 49 patients in the ITT analysis was 35.5\u00a0months, suggesting that survival outcomes in the present study were better than those in the studies included in the meta-analysis.This trial showed that the 2-year PFS rate was 58.1% among 31 patients who completed Nac before receiving R0/R1 resection (per-protocol). In the per-protocol analysis, the primary endpoint yielded values that were better than expected. However, in the ITT analysis of 49 patients, including those who failed the protocol, the 2-year PFS rate was 40.8%, which was below the reference value. Trials of adjuvant therapy, such as the JASPAC01 study, have reported better results than those of the ITT analysis, due to the exclusion of patients with metastasis confirmed during surgery or those with poor PS after resection and at the time of adjuvant therapy initiationP\u2009=\u20090.029), but not for Nac patients with R-PDAC 5. The subgroup settings for R-PDAC in the PREOPANC trial might be under-powered for analysis (65 Nac vs. 68 upfront surgery); furthermore, the median OS was 14.6\u00a0months in the Nac group, which was a disappointing finding. Nevertheless, the Prep-02/JSAP-05 trial  reported in preliminary findings that a significant benefit was observed with Nac compared with upfront surgery 6. At present, no other trials have delivered high-quality evidence on the impact of Nac on R-PDAC compared with upfront surgery.At present, the evidence level for Nac in R-PDAC remains low and the optimal protocol remains unknown. At least eight trials have compared the role of neoadjuvant treatment with that of upfront surgery in the outcome of R-PDAC, and their preoperative protocols vary . Of these, the PREOPANC trial  was the first randomized phase III trial to publish findings on the use of Nac for PDAC (including both borderline resectable and resectable); a preplanned subgroup ITT analysis demonstrated superior OS for Nac patients with BR-PDAC , and the R0 resection rate among the resected cases was 93% (40/43), suggesting that preoperative adjuvant therapy with S-1 monotherapy can achieve local tumor control in R-PDAC.The estimated MST of the ITT analysis of our Nac S-1 monotherapy was 35.5\u00a0months, while the estimated MST in the ITT analysis of the Nac Gem plus S-1 (GS) patients in the Prep-02/JSAP-05 was 36.7\u00a0months, with no difference in survival. No data were available for comparing S-1 with GS in R-PDAC survival; however, the GEST study, which was a randomized three-arm phase III study for advanced pancreatic cancer, showed non-inferiority of S-1, but did not show superiority of GS to Gem alone for OS14. The present trial included patients with an Asian background. However, pharmacokinetic and pharmacodynamic profile examination was outside the scope of the present study; thus, the exact reasons behind protocol failures associated with gastrointestinal toxicity remain unclear. We speculate that patients and physicians might be concerned about undergoing surgery when even minor gastrointestinal toxicities are present, as pancreatic resection is a major surgery and requires a cautious approach. An advantage of S-1 therapy is that it is a single oral agent that does not require intravenous treatment or frequent outpatient visits, thereby preserving medical resources. Nevertheless, the risk of gastrointestinal symptoms is high. In addition, this treatment might not be suitable for use in non-Asian populations.In this study, Nac was well-tolerated from the viewpoint of hematological markers; however, the gastrointestinal toxicity rate was high . S-1 is associated with a risk of gastrointestinal toxicities, which are generally higher in Caucasian than in Asian populations due to differences in pharmacokinetics and pharmacodynamicsThe second leading factor for Nac failure in the present study was patient refusal to continue with treatment despite the absence of severe AEs. In fact, patients were more likely to select surgical resection than to continue with Nac. As surgical resection is the only curative treatment for R-PDAC, patients might be eager to avoid tumor progression, which would make them ineligible for surgery. In fact, patients who refused to continue Nac had a strong desire for resection; four of five patients proceeded to surgery after discontinuing Nac. One of the possibilities for the strong desire for resection may be the patients\u2019 medical expenses for chemotherapy, and the other may be the inconvenience of outpatient chemotherapy. Future trials should present evidence to patients considering Nac discontinuation, and patients should be informed about the importance of completing Nac in the absence of AEs rather than immediately undergoing surgery.In conclusion, S-1 neoadjuvant therapy for R-PDAC is safe and promising. S-1 monotherapy can be used as neoadjuvant therapy for patients with R-PDAC. However, well-designed, randomized controlled trials are required to better understand the safety profile and efficacy of this approach.16 .This study was a multicenter, open-label, single-arm phase II trial of Nac S-1 in patients with R-PDAC, conducted by the Hokkaido Pancreatic Cancer Study Group (HOPS)2, 50\u00a0mg for a body-surface area of 1.25\u20131.5 m2, or 60\u00a0mg for a body-surface area of\u2009>\u20091.5 m2, administered twice per day for 28 consecutive days, followed by a 14-day rest period (one cycle). The length of Nac was 12\u00a0weeks, which was slightly shorter than the reported median PFS of S-112, to balance the chance of resection with adequate tumor suppression and patient selection. After completing Nac, all patients underwent dynamic MDCT for restaging. All patients eligible for pancreatic resection underwent surgery 2\u20136\u00a0weeks after completing Nac. Patients with distant metastasis or locally advanced disease were excluded from this study, with further treatment at the discretion of the attending physician. All patients with R0/R1 surgical resection received four cycles of adjuvant S-1 therapy, which followed the same protocol as Nac. After completing therapy, all patients were followed up once every 3\u00a0months during the first 2\u00a0years, and once every 6\u00a0months from year 3 onwards. Tumor markers and MDCT of the chest/abdomen/pelvis or gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid enhanced magnetic resonance imaging were monitored during the follow-up period, which ended 2\u00a0years after the enrollment of the last patient.The Nac protocol involved two cycles of 40\u00a0mg of oral S-1 for a body-surface area of\u2009<\u20091.25 m3 and\u2009<\u200912,000/mm3, neutrophil count\u2009\u2265\u20092000/mm3, hemoglobin\u2009\u2265\u20099.0\u00a0g/dL, platelet count\u2009\u2265\u2009100,000/mm3, total bilirubin\u2009\u2264\u20092.0\u00a0mg/dL [\u2264\u20093.0\u00a0mg/dL in patients with biliary drainage], aspartate transaminase and alanine aminotransferase\u2009\u2264\u2009100\u00a0IU [\u2264\u2009150\u00a0IU in patients with biliary drainage], creatinine\u2009\u2264\u20091.2\u00a0mg/dL, and creatinine clearance estimate by Cockcroft-Gault equation\u2009\u2265\u200950\u00a0mL/min). Exclusion criteria: history of S-1 treatment; history of PDAC treatment; another simultaneous or metachronous (within 3\u00a0years) cancer; current use of flucytosine, phenytoin or warfarin; watery diarrhea; pulmonary fibrosis or intestinal pneumonia; and confirmed or suspected pregnancy in women.Central review of diagnostic imaging was performed according to the definition of the NCCN guidelines 2012 (version 2) by a radiologist (YS) and verified by a surgeon (TN) and a physician (HK). Inclusion criteria: cytologically or histologically confirmed PDAC; age\u2009\u2265\u200920\u00a0years; Eastern Cooperative Oncology Group PS of 0 to 1; sufficient dietary intake; and satisfactory levels of blood parameters .Preoperative treatment-related AEs were assessed using the Common Terminology Criteria for Adverse Events (version 3.0). Surgical resection was performed by laparotomy and regional lymph node dissection was required. Resection of the portal vein/superior mesenteric vein was allowed. A DP-CAR due to suspected tumor involvement in tumor proximity to the bifurcation of the celiac and splenic artery was allowedThe primary endpoint was 2-year PFS. Secondary endpoints included OS, resection, and response rates, measured according to RECISTv1.1, pathological outcomes, preoperative treatment-related AEs, and surgical morbidity rate. PFS was defined as the time from registration with the trial to the date of first recurrence or disease progression, either local, distant, or both, whichever occurred first. Recurrence was defined as a radiologically rather than elevation of CA19-9. OS was defined as time from registration to the date of death from any cause and censored on the date of the final confirmation of survival for surviving patients. It was estimated using the Kaplan\u2013Meier method.10. Given this threshold (29%) and expected 2-year PFS (48%), the sample size was calculated as 46, based on the Southwest Oncology Group one arm binomial tool, with a significance level of 0.025 and power of 80%. In anticipation of loss to follow-up, we expected to enroll 50 patients in the present study.To calculate the desired sample size for the present study, the threshold and expected values of the 2-year PFS rates were set at 29% and 48%, respectively. These estimates were based on the JASPAC01 study findings, where 2-year RFS was 48% in the S-1 group and 29% in the Gem group in an adjuvant settingSupplementary Information 1.Supplementary Information 2.Supplementary Information 3.", "texts": ["Although neoadjuvant therapy (Nac) is recommended for high-risk resectable pancreatic cancer (R-PDAC), evidence regarding specific regimes is scarce. This report aimed to investigate the efficacy of S-1 Nac for R-PDAC. In a multicenter phase II trial, we investigated the efficacy of Nac S-1  in R-PDAC patients. The protocol involved two cycles of preoperative S-1 chemotherapy, followed by surgery, and four cycles of postoperative S-1 chemotherapy. Two-year progression-free survival (PFS) rates were the primary endpoint. Overall survival (OS) rates and median survival time (MST) were secondary endpoints. Forty-nine patients were eligible, and 31 patients underwent resection following Nac, as per protocol . Per-protocol analysis included data from 31 patients, yielding the 2-year PFS rate of 58.1%, and 2-, 3-, and 5-year OS rates of 96.8%, 54.8%, and 44.0%, respectively. MST was 49.2\u00a0months. Intention-to-treat analysis involved 49 patients, yielding the 2-year PFS rate of 40.8%, and the 2-, 3-, and 5-year OS rates of 87.8%, 46.9%, and 33.9%, respectively. MST was 35.5\u00a0months. S-1 single regimen might be an option for Nac in R-PDAC; however, the high drop-out rate (36.7%) was a limitation of this study. However, evidence regarding specific regimens for Nac in R-PDAC is scarce, and participation in clinical trials is encouraged. A recent meta-analysis reported that the median overall survival (OS) of R-PDAC ranged from 12 to 25.3\u00a0months in upfront surgery, while the median OS associated with Nac group ranged from 10 to 50.2\u00a0months2. A separate meta-analysis based on intention-to-treat analyses has shown that patients with PDAC who received Nac had better long-term survival outcomes than patients who received upfront surgery 3. In a large-scale propensity-score matched analysis, Nac with upfront surgery was associated with improved survival 4. At present, at least eight randomized trials have investigated the use of Nac for R-PDAC. However, only two trials have reported long-term outcomes associated with preoperative treatment6. One of the trials was PREOPANC trial that showed survival benefit of preoperative chemoradiotherapy using gemcitabine with radiation 5. The other trial was Prep-02/JSAP-05 trial that showed survival benefit of Nac using gemcitabine with S-1 6. Thus, there is sparse evidence with respect to the administration of Nac for R-PDAC and the optimal protocol.The National Comprehensive Cancer Network (NCCN) guidelines recommend upfront surgery for patients with resectable pancreatic ductal adenocarcinoma (R-PDAC) , or neoadjuvant therapy (Nac) is also recommended for high-risk R-PDAC cases, such as those involving high levels of tumor marker, large primary tumors, weight loss, and so on9. As such, the main purpose of Nac in the treatment of R-PDAC is the prevention of postoperative recurrence, which is consistent with postoperative adjuvant therapy. Preoperative treatment of R-PDAC does not need to reduce tumor size, as even if the local effect is weak, R0 resection is possible in cases of stable disease.The theoretical benefits of neoadjuvant therapy in R-PDAC are (a) early treatment of potentially metastatic disease, (b) identification of patients diagnosed with metastatic disease during treatment who can be spared surgical procedures that are unlikely to have survival benefit, and (c) delivery of chemotherapy and radiation to the primary tumor while it is in an intact, well-vascularized condition. In cases of R-PDAC, downsizing strategies to improve R0 resectability are not as important as they are in cases of borderline resectable PDAC or locally advanced PDAC. It should be noted that early treatment of potentially metastatic disease involves the same strategy as postoperative adjuvant therapy; however, only approximately 60% of patients with PDAC receive postoperative adjuvant therapy in the real world setting due to perioperative morbidity or early disease recurrenceP\u2009<\u20090.0001)10. In the same trial, disease recurrence in the liver was observed in 29% of patients in the Gem group and in 19% of patients in the S-1 group (P\u2009=\u20090.0016). Based on these findings, we hypothesized that S-1 might decrease the risk of micrometastasis, such as occult liver metastasis, in cases of R-PDAC. We conducted a multicenter single-arm phase II clinical trial to investigate the efficacy of S-1 Nac in patients with R-PDAC. This study is the first trial to focus on the prevention of R-PDAC recurrence using only a single oral agent for preoperative treatment.Given the advantages of Nac, S-1  was selected for use in the present study; this regimen has been associated with relatively good outcomes as postoperative adjuvant therapy. The JASPAC01 trial has shown that the S-1 regimen is a superior adjuvant therapy to gemcitabine (Gem) in patients with R-PDAC  findings, under the informed consent. We enrolled 49 patients in this trial between January 2014 and October 2015. The CONSORT study flow summary is presented in Fig.\u00a0Treatment-related adverse events (AEs) are shown in Table After completing Nac, 33 patients proceeded to surgery Fig.\u00a0. ConcurrThe postoperative complications after pancreatectomy are shown in Table Of 31 patients who completed Nac followed by R0/R1 resection, 28 (90.3%) started S-1 adjuvant therapy and three patients did not (2 patients had poor performance status (PS) and one patient had bone metastasis before adjuvant therapy). Twenty-two patients completed all pre- and postoperative therapies as per study protocol (45% of 49 eligible patients and 71% of completed Nac patients). Meanwhile, among 12 patients who discontinued Nac, but received R0/R1 resection, 8 (66.7%) patients started adjuvant therapy and six patients completed it. Another four patients refused any chemotherapy.The 2-year progression-free survival (PFS) rate was 58.1% in 31 patients who completed Nac (per-protocol) followed by R0/R1 resection, and 40.8% in the intension-to-treat (ITT) analysis that included all 49 eligible patients  was 35.5\u00a0months. The observed 2-, 3-, and 5-year OS rates for per-protocol patients (n\u2009=\u200931) were 80.7%, 54.8%, and 44.0%, respectively, and the MST was 49.2\u00a0months. The 2-, 3-, and 5-year OS rates for off-protocol patients (n\u2009=\u200918) were 55.6%, 38.9%, and 11.1%, respectively, and the MST was 27.6\u00a0months  are shown in Supplemental Table Se3. Of the per-protocol (Nac complete) resection patients (n\u2009=\u200931), 18 (58.1%) patients experienced disease recurrence; this rate was lower than that of the off-protocol (Nac failure) resections . The rate of distant metastasis was high among off-protocol resections (75% vs. 48.3%). Liver recurrence (disease progression) for per-protocol resections, off-protocol resections, and non-resection was found in 25.8%, 33.3%, and 50% of cases, respectively.3. In fact, the present study subpopulation that met the JASPAC01 trial criteria showed relatively better survival . A recent meta-analysis, including 18 studies that involved 857 patients, has reported that the MST associated with Nac for patients with R-PDAC was 18.2\u00a0months (range: 10\u201350.2\u00a0months)2. In our trial, the MST of all 49 patients in the ITT analysis was 35.5\u00a0months, suggesting that survival outcomes in the present study were better than those in the studies included in the meta-analysis.This trial showed that the 2-year PFS rate was 58.1% among 31 patients who completed Nac before receiving R0/R1 resection (per-protocol). In the per-protocol analysis, the primary endpoint yielded values that were better than expected. However, in the ITT analysis of 49 patients, including those who failed the protocol, the 2-year PFS rate was 40.8%, which was below the reference value. Trials of adjuvant therapy, such as the JASPAC01 study, have reported better results than those of the ITT analysis, due to the exclusion of patients with metastasis confirmed during surgery or those with poor PS after resection and at the time of adjuvant therapy initiationP\u2009=\u20090.029), but not for Nac patients with R-PDAC 5. The subgroup settings for R-PDAC in the PREOPANC trial might be under-powered for analysis (65 Nac vs. 68 upfront surgery); furthermore, the median OS was 14.6\u00a0months in the Nac group, which was a disappointing finding. Nevertheless, the Prep-02/JSAP-05 trial  reported in preliminary findings that a significant benefit was observed with Nac compared with upfront surgery 6. At present, no other trials have delivered high-quality evidence on the impact of Nac on R-PDAC compared with upfront surgery.At present, the evidence level for Nac in R-PDAC remains low and the optimal protocol remains unknown. At least eight trials have compared the role of neoadjuvant treatment with that of upfront surgery in the outcome of R-PDAC, and their preoperative protocols vary . Of these, the PREOPANC trial  was the first randomized phase III trial to publish findings on the use of Nac for PDAC (including both borderline resectable and resectable); a preplanned subgroup ITT analysis demonstrated superior OS for Nac patients with BR-PDAC , and the R0 resection rate among the resected cases was 93% (40/43), suggesting that preoperative adjuvant therapy with S-1 monotherapy can achieve local tumor control in R-PDAC.The estimated MST of the ITT analysis of our Nac S-1 monotherapy was 35.5\u00a0months, while the estimated MST in the ITT analysis of the Nac Gem plus S-1 (GS) patients in the Prep-02/JSAP-05 was 36.7\u00a0months, with no difference in survival. No data were available for comparing S-1 with GS in R-PDAC survival; however, the GEST study, which was a randomized three-arm phase III study for advanced pancreatic cancer, showed non-inferiority of S-1, but did not show superiority of GS to Gem alone for OS14. The present trial included patients with an Asian background. However, pharmacokinetic and pharmacodynamic profile examination was outside the scope of the present study; thus, the exact reasons behind protocol failures associated with gastrointestinal toxicity remain unclear. We speculate that patients and physicians might be concerned about undergoing surgery when even minor gastrointestinal toxicities are present, as pancreatic resection is a major surgery and requires a cautious approach. An advantage of S-1 therapy is that it is a single oral agent that does not require intravenous treatment or frequent outpatient visits, thereby preserving medical resources. Nevertheless, the risk of gastrointestinal symptoms is high. In addition, this treatment might not be suitable for use in non-Asian populations.In this study, Nac was well-tolerated from the viewpoint of hematological markers; however, the gastrointestinal toxicity rate was high . S-1 is associated with a risk of gastrointestinal toxicities, which are generally higher in Caucasian than in Asian populations due to differences in pharmacokinetics and pharmacodynamicsThe second leading factor for Nac failure in the present study was patient refusal to continue with treatment despite the absence of severe AEs. In fact, patients were more likely to select surgical resection than to continue with Nac. As surgical resection is the only curative treatment for R-PDAC, patients might be eager to avoid tumor progression, which would make them ineligible for surgery. In fact, patients who refused to continue Nac had a strong desire for resection; four of five patients proceeded to surgery after discontinuing Nac. One of the possibilities for the strong desire for resection may be the patients\u2019 medical expenses for chemotherapy, and the other may be the inconvenience of outpatient chemotherapy. Future trials should present evidence to patients considering Nac discontinuation, and patients should be informed about the importance of completing Nac in the absence of AEs rather than immediately undergoing surgery.In conclusion, S-1 neoadjuvant therapy for R-PDAC is safe and promising. S-1 monotherapy can be used as neoadjuvant therapy for patients with R-PDAC. However, well-designed, randomized controlled trials are required to better understand the safety profile and efficacy of this approach.16 .This study was a multicenter, open-label, single-arm phase II trial of Nac S-1 in patients with R-PDAC, conducted by the Hokkaido Pancreatic Cancer Study Group (HOPS)2, 50\u00a0mg for a body-surface area of 1.25\u20131.5 m2, or 60\u00a0mg for a body-surface area of\u2009>\u20091.5 m2, administered twice per day for 28 consecutive days, followed by a 14-day rest period (one cycle). The length of Nac was 12\u00a0weeks, which was slightly shorter than the reported median PFS of S-112, to balance the chance of resection with adequate tumor suppression and patient selection. After completing Nac, all patients underwent dynamic MDCT for restaging. All patients eligible for pancreatic resection underwent surgery 2\u20136\u00a0weeks after completing Nac. Patients with distant metastasis or locally advanced disease were excluded from this study, with further treatment at the discretion of the attending physician. All patients with R0/R1 surgical resection received four cycles of adjuvant S-1 therapy, which followed the same protocol as Nac. After completing therapy, all patients were followed up once every 3\u00a0months during the first 2\u00a0years, and once every 6\u00a0months from year 3 onwards. Tumor markers and MDCT of the chest/abdomen/pelvis or gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid enhanced magnetic resonance imaging were monitored during the follow-up period, which ended 2\u00a0years after the enrollment of the last patient.The Nac protocol involved two cycles of 40\u00a0mg of oral S-1 for a body-surface area of\u2009<\u20091.25 m3 and\u2009<\u200912,000/mm3, neutrophil count\u2009\u2265\u20092000/mm3, hemoglobin\u2009\u2265\u20099.0\u00a0g/dL, platelet count\u2009\u2265\u2009100,000/mm3, total bilirubin\u2009\u2264\u20092.0\u00a0mg/dL [\u2264\u20093.0\u00a0mg/dL in patients with biliary drainage], aspartate transaminase and alanine aminotransferase\u2009\u2264\u2009100\u00a0IU [\u2264\u2009150\u00a0IU in patients with biliary drainage], creatinine\u2009\u2264\u20091.2\u00a0mg/dL, and creatinine clearance estimate by Cockcroft-Gault equation\u2009\u2265\u200950\u00a0mL/min). Exclusion criteria: history of S-1 treatment; history of PDAC treatment; another simultaneous or metachronous (within 3\u00a0years) cancer; current use of flucytosine, phenytoin or warfarin; watery diarrhea; pulmonary fibrosis or intestinal pneumonia; and confirmed or suspected pregnancy in women.Central review of diagnostic imaging was performed according to the definition of the NCCN guidelines 2012 (version 2) by a radiologist (YS) and verified by a surgeon (TN) and a physician (HK). Inclusion criteria: cytologically or histologically confirmed PDAC; age\u2009\u2265\u200920\u00a0years; Eastern Cooperative Oncology Group PS of 0 to 1; sufficient dietary intake; and satisfactory levels of blood parameters .Preoperative treatment-related AEs were assessed using the Common Terminology Criteria for Adverse Events (version 3.0). Surgical resection was performed by laparotomy and regional lymph node dissection was required. Resection of the portal vein/superior mesenteric vein was allowed. A DP-CAR due to suspected tumor involvement in tumor proximity to the bifurcation of the celiac and splenic artery was allowedThe primary endpoint was 2-year PFS. Secondary endpoints included OS, resection, and response rates, measured according to RECISTv1.1, pathological outcomes, preoperative treatment-related AEs, and surgical morbidity rate. PFS was defined as the time from registration with the trial to the date of first recurrence or disease progression, either local, distant, or both, whichever occurred first. Recurrence was defined as a radiologically rather than elevation of CA19-9. OS was defined as time from registration to the date of death from any cause and censored on the date of the final confirmation of survival for surviving patients. It was estimated using the Kaplan\u2013Meier method.10. Given this threshold (29%) and expected 2-year PFS (48%), the sample size was calculated as 46, based on the Southwest Oncology Group one arm binomial tool, with a significance level of 0.025 and power of 80%. In anticipation of loss to follow-up, we expected to enroll 50 patients in the present study.To calculate the desired sample size for the present study, the threshold and expected values of the 2-year PFS rates were set at 29% and 48%, respectively. These estimates were based on the JASPAC01 study findings, where 2-year RFS was 48% in the S-1 group and 29% in the Gem group in an adjuvant settingSupplementary Information 1.Supplementary Information 2.Supplementary Information 3."]}
{"representative": "In the original publication, the name of fourth and seventh authors were incorrectly published as: Takashi Sangai and Hidetoshi Kawagichi. The correct version of names are: Takafumi Sangai and Hidetoshi Kawaguchi as given in this Correction.The original publication has been corrected.", "texts": ["In the original publication, the name of fourth and seventh authors were incorrectly published as: Takashi Sangai and Hidetoshi Kawagichi. The correct version of names are: Takafumi Sangai and Hidetoshi Kawaguchi as given in this Correction.The original publication has been corrected."]}
{"representative": "BackgroundPrognostication plays a pivotal role in critical care medicine. Its importance is indisputable in the management of coronavirus disease 2019 (COVID-19), as the presentation of this disease may vary from docile, self-limiting symptoms to lethal conditions.\u00a0Amid the COVID-19 pandemic, much emphasis was initially placed on molecular and serological testing. However, it was\u00a0realized later that routine laboratory tests also\u00a0provide\u00a0key information in terms of the severity of the disease and thus could be used to predict the outcome of these patients.MethodologyThe aim of our study was to evaluate the biochemical parameters as prognostic markers in severely ill COVID-19 patients. We carried out a retrospective, case-control study. The study population was comprised of all severely ill COVID-19 patients\u00a0admitted between October 2020 and January 2021 at our level 3\u00a0COVID hospital.\u00a0Cases were defined as the patients who expired despite treatment and all resuscitative measures as per the standard operating procedures (SOPs) of our COVID intensive care unit (ICU)\u00a0while controls were defined as the patients that were transferred out of the COVID\u00a0ICU for further recovery. The detailed history, findings of physical examination, vitals recorded by point of care testing (POCT) devices at our ICU, clinical diagnosis, and the results of the biochemical analysis\u00a0were recorded in a specially designed pro forma. The biochemical parameters recorded at the time of admission\u00a0were compared between the groups of controls and cases in order to evaluate their role as predictors of mortality using appropriate statistical methods. P-values less than 0.05 were considered statistically significant. For all the parameters that showed a statistically significant difference, receiver operating characteristics (ROC) analysis was done\u00a0to assess the utility of biochemical parameters as predictors of mortality or survival. Areas under the curve (AUCs) of 0.6 to 0.7, 0.7 to 0.8,\u00a00.8 to 0.9, and >0.9 were considered\u00a0acceptable,\u00a0fair,\u00a0good, and\u00a0excellent for discrimination, respectively.ResultsOf the 178 severely ill COVID-19 patients enrolled in the study,\u00a086 were controls and 92 were cases .\u00a0Serum urea (p<0.0001), creatinine (p=0.0019), aspartate transaminase (AST) (p=0.0104), lactate dehydrogenase (LDH) (p=0.0001), procalcitonin (PCT)\u00a0(p=0.0344), and interleukin 6 (IL-6) (p=0.0311) levels were significantly higher (p<0.05), while total protein (p=0.0086), albumin\u00a0(p<0.0001), and indirect bilirubin\u00a0(p=0.0147) levels were significantly lower\u00a0(p<0.05) in\u00a0cases as compared to controls. The difference was statistically insignificant\u00a0(p>0.05) for serum sodium, potassium, total and direct bilirubin, globulin, alanine transaminase (ALT), alkaline phosphatase (ALP), D-dimer, and ferritin. On ROC analysis, urea was fair (AUC=0.721), creatinine (AUC=0.698) and IL-6 (AUC=0.698) were acceptable predictors of mortality, while albumin (AUC=0.698) was an acceptable predictor of survival in severely ill COVID-19 patients during their intensive care stay.ConclusionUnderstanding the pathophysiological changes associated with the severity of COVID-19 in terms of an alteration of biochemical parameters is a pressing priority.\u00a0Our study highlights the importance of routine laboratory tests in predicting outcomes in severely ill COVID-19 patients. Prognostication plays a crucial role in the management of coronavirus disease COVID-19) 9 1-8]. . 8]. It . . 8]. ICOVID-19 is an infectious disease caused by severe acute respiratory syndrome (SARS ) coronavirus 2 (CoV-2)\u00a0,4. MortaLaboratory tests are particularly useful in validating a diagnosis, predicting disease severity, and monitoring disease progression in patients with infectious diseases like COVID-19 -18. TimeAn observational, retrospective, case-control study\u00a0was conducted after obtaining approval from the Institutional Ethics Committee (IEC) of Shri Ram Murti Smarak Institute of Medical Sciences. We utilized data from all the patients admitted to the\u00a0COVID\u00a0intensive care unit (ICU) of our hospital,\u00a0Shri Ram Murti Smarak (SRMS) Institute of Medical Sciences (IMS), Bareilly, Uttar Pradesh, India, from 1st October 2020 to 31st January 2021. As per the standard operating procedures (SOPs) of our institute, patients with clinical syndromes associated with COVID-19 infection (referred\u00a0from the emergency department or wards of other departments) were admitted to our COVID ICU. These patients were screened (based on the following inclusion and exclusion criteria) for their eligibility as study participants .\u00a0Only seThe following diagnostic definitions were used to define severely ill COVID-19 patients:1. COVID-19 PatientsDefined as patients with clinical syndromes associated with COVID-19, who tested positive for either real-time-polymerase chain reaction (RT-PCR) TrueNat or Rapid Antigen Test (RAT) for COVID-19 ,17.2. Severely Ill COVID-19 PatientsOur ICU follows the \"Revised Guidelines on Clinical Management of COVID-19\", issued by the Government of India Ministry of Health & Family Welfare Directorate General of Health Services (EMR Division) to define severely ill COVID-19 patients ,16,18,192) less than 90 percent (%) on room air [(A)\u00a0Severe pneumonia: Defined as a patient suspected of having respiratory tract infection, with one or more of the following: 1) Respiratory rate greater than 30 breaths per minute; 2) Severe respiratory distress; 3) Peripheral capillary oxygen saturation  less than 200 (millimeters of mercury) mmHg or fraction of inspired oxygen (FiO2) less than or equal to 300 mmHg (with positive end-respiratory pressure (PEEP) or continuous positive airway pressure (CPAP) more than or equal to 5 centimeters (cm) of water (H2O)); (b) When PaO2 is not available, SpO2\u00a0or FiO2 less than or equal to 315; (c) Respiratory distress in non-ventilated patients [(B) Acute respiratory distress syndrome (ARDS): Defined as follows: 1) The development of new or worsening respiratory symptoms within one week of known exposure; 2) Bilateral opacities\u00a0not\u00a0explained by chest imaging studies; 3) Respiratory failure caused by factors other than\u00a0cardiac failure or fluid overload; 4) Mild, moderate or severe ARDS: Defined as (a) Partial pressure of oxygen in arterial blood  Sepsis: Defined as a dysregulated host response to infection resulting in\u00a0life-threatening organ dysfunction, diagnosed by: 1) Symptoms like altered mental status, difficult or fast breathing, or skin mottling; 2) Signs like low oxygen saturation, reduced urine output, fast heart rate, weak pulse, cold extremities or low blood pressure;\u00a03) Laboratory evidence like\u00a0coagulopathy, thrombocytopenia, acidosis, high lactate, or hyperbilirubinemia\u00a0,18,19.(D) Septic shock: Defined as persisting hypotension despite appropriate volume resuscitation, requiring vasopressors in order to maintain mean arterial pressure (MAP) more than or equal to 65 mmHg and serum lactate level less than 2 mmol/L\u00a0,16,18,19We excluded the following patients from our study: 1) Suspected cases of COVID-19 with no confirmatory laboratory results; 2) Laboratory confirmed COVID-19 cases that do not meet our criteria for severely ill COVID-19 patients; 3) Patients with insufficient data for further analysis, who denied the standard treatment protocol of our hospital or discharged against medical advice.Admission, history-taking, physical examination, analysis (done either by point of care testing (POCT) devices at the ICU or autoanalyzers at the laboratory), and management of all patients were done following the SOPs\u00a0of our institute. Data required for the study were retrieved from patients\u2019 clinical case files archived at the COVID ICU and our laboratory and hospital information systems (LIS and HIS), version 3. These endogenous information systems were developed by professionals of our engineering college  in 2017. Patients\u2019 clinical profiles  and laboratory results of blood samples collected at the time of admission to the COVID ICU were recorded in an especially designed pro forma. All the biochemical parameters , aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP), lactate dehydrogenase (LDH), urea, creatinine, sodium (Na+), and potassium (K+)) were analyzed in the biochemistry section while D-dimer and procalcitonin (PCT) estimation was done at the pathology section of our Central Clinical Laboratory. Serum interleukin-6 (IL-6) and ferritin levels were measured in the Chemiluminescence Immunoassay (CLIA) section of our Central Research Laboratory. All parameters were analyzed following the SOPs of the respective sections of our laboratories. Table We categorized the data of the subjects based on their outcome (Survivors or Non-survivors) during their stay in the\u00a0ICU. The survivors were designated as the control group\u00a0while the non-survivors were the case group. We compared the results of the blood samples collected at the time of admission to the COVID ICU between the controls\u00a0and cases to study the role of these biochemical markers in the prediction of mortality in severely ill COVID-19 patients.Categorical variables were described as frequency and percentages using demographics and continuous variables as mean and standard deviation (SD). Quantitative data were assessed for linearity using Kolmogorov-Smirnov analysis and tests of statistical significance (student\u2019s unpaired t-test or Mann-Whitney-U test) were used depending upon the data type. Means for continuous variables were compared using independent group p-values in MedCalc software. The parameters with p-values less than 0.05 were considered statistically significant. Receiver operating characteristics (ROC) curve analysis was utilized  to assess the utility of biochemical parameters to predict mortality or survival. AUC of 0.6 to 0.7, 0.7 to 0.8,\u00a00.8 to 0.9, and >0.9 were considered\u00a0acceptable,\u00a0fair,\u00a0good, and\u00a0excellent discrimination, respectively. Further, for all parameters with an AUC > 0.6, the sensitivity and specificity\u00a0as\u00a0predictors of survival or mortality (at specific cut-offs) were also\u00a0assessed on the basis of the ROC analysis.Out of 231 critically ill patients admitted to our COVID ICU between October\u00a0and January\u00a02021, 178 severely ill COVID-19 patients were enrolled in the present study (based on our inclusion). We excluded\u00a053\u00a0patients  based on our exclusion criteria. Out of 178 patients enrolled in the study, 134 (75.28%) were males and 44 (24.72%) were females. The youngest patient was 14 years old and the oldest patient was 97 years old, while the average age was found to be 62 years. The greatest number of patients (74.72%) belonged to the age group of 51-80 years.\u00a0Figure We categorized\u00a0178 patients enrolled in our study\u00a0based on their outcomes (survivors or Non-survivors) during their stay in the ICU. Table The biochemical parameters\u00a0showed statistically significant differences (p<0.05)\u00a0in their average values\u00a0between the cases and controls groups. A statistically significant difference was observed for serum urea (p<0.0001), creatinine (p=0.0019), indirect bilirubin (p=0.0147), serum protein (p=0.0086), albumin (p<0.0001), AST (p=0.0104), LDH (p=0.0001), PCT p=0.0344), and IL-6 (p=0.0311)  curves were plotted for all the parameters that showed a statistically significant difference between the cases and controls. Below, we are reporting only the results of the ROC curve analysis for the parameters that were found to be predictors of mortality or survival based on AUC Table .The ROC curve for serum urea and serum creatinine as predictors of mortality has an area under the curve (AUC) of 0.721 (fair predictor) and 0.698 (acceptable), respectively. For a cut-off value of 52 mg/dl for serum urea, the sensitivity and specificity are 0.736 and 0.605, respectively, while for a cut-off value of 0.95 mg/dl for serum creatinine level, the sensitivity and specificity are 0.747 and 0.605, respectively, as a predictor of mortality\u00a0, which puts it at the upper bounds of an acceptable score. For a cut-off value of 44.41 pg/ml of serum IL-6, the sensitivity and specificity are 0.703 and 0.605, respectively, as a predictor of mortality\u00a0, which puts it at the upper bounds of an acceptable score. For a cut-off value of 3.25 g/dl of serum albumin, the sensitivity and specificity are 0.767 and 0.593, respectively, as predictors of survival\u00a0Figure .In our study, critically ill COVID-19 patients showed distinct clinical, demographic, and laboratory features at the time of\u00a0ICU\u00a0admission. It was observed that men are more affected by COVID-19 in terms of both morbidity and mortality. Previous studies showed that this could be due to the expression of more angiotensin-converting enzyme 2 (ACE2) receptors in men than in women . MoreoveSerum urea (p<0.0001),creatinine (p=0.0019), AST\u00a0(p=0.0104), LDH\u00a0(p=0.0001), procalcitonin (PCT)\u00a0(p=0.0344), and IL-6\u00a0(p=0.0311) levels were significantly higher (p<0.05) while total protein (p=0.0086), albumin\u00a0(p<0.0001), and indirect bilirubin\u00a0(p=0.0147) levels were significantly lower\u00a0(p<0.05) in\u00a0cases as compared to controls.The difference was statistically insignificant\u00a0(p>0.05) for serum sodium, potassium, total and direct bilirubin, globulin, ALT, ALP, D-dimer, and ferritin.Abnormal renal function tests (higher levels of serum urea and creatinine) were reported in our study and the difference was found to be highly significant (urea (p<0.0001) and creatinine (p=0.0019)) between the controls and cases. The ROC\u00a0curve for\u00a0urea AUC=0.721) and creatinine (AUC=0.698) were found to be fair and acceptable predictors of mortality, respectively. For a cut-off value of 52 mg/dl for\u00a0urea level, the sensitivity and specificity are 0.736 and 0.605, respectively, while for a cut-off value of 0.95 mg/dl for\u00a0creatinine level, the sensitivity and specificity were 0.747 and 0.605, respectively\u00a0 was found to be statistically insignificant . Many of these  are reported to have good prognostic value in several studies .Based on the findings of our study, we propose biochemical parameters as practical prognostic markers in severely ill COVID-19 patients due to the routine practice of their monitoring (owing to their easy availability) in these patients.We assume that the manifestation of clinical syndromes associated with severe COVID-19 is the actual time when the development of metabolic alterations responsible for death in severely ill COVID-19 patients is triggered. Based on this, we postulate that prognosticating at this triggering moment has to be both\u00a0sensitive and specific ,16,18,19Based on the observations of this study, we believe that routine biochemistry parameters can be used as feasible prognostic markers in severely ill COVID-19 patients. With the help of easily available prognostic markers, COVID-19 patients at higher risk of poor outcomes can be appropriately managed\u00a0-9. With The main strength of this study is its planning and execution at an ICU known for its quality services and adherence to SOPs and protocols. The well-planned study , the inclusion of results of the investigation done at the time of identification of clinical syndromes associated with severe COVID-19 in all study participants, and the quantitative analysis of all biochemical parameters using cutting-edge methods\u00a0are some of the positive aspects of our study ,18,19,27The main limitation of this study\u00a0is its retrospective design. However, we assume that the accuracy of the findings is acceptable, as we followed the SOPs prevalent in our institute for both biochemical\u00a0investigations\u00a0as well as the management of all patients enrolled in the study. The limited sample size and\u00a0inclusion of patients with pre-existing diseases (including those who required invasive ventilation) are the major limitations. Studies with a larger sample size, with a special emphasis on understanding the role of other factors  on the biochemical profile of these patients and their correlation with adverse outcomes are direly needed. A study of these biochemical parameters in mild and moderate cases\u00a0of COVID-19 as well would provide a better understanding of these biochemical alterations and their relation to the development of severe illness. Understanding these biochemical alterations would not only\u00a0help in prognosticating the risk of development of severe illness but also guide the development of better treatment protocols ,19,28,29Renal dysfunction (elevated levels of serum urea and\u00a0creatinine) and elevated serum IL-6 levels but lower serum albumin levels were found to be the best prognostic markers of in-hospital mortality of severely ill COVID-19 patients in our study population.\u00a0We propose that the vigilant monitoring of these biochemical parameters can aid in the prognostication of COVID-19 and thus improve the clinical management of these high-risk patients. However, large\u2010scale, multicenter studies designed to evaluate the prognostic utility of these parameters in the prognostication of COVID-19, especially in severely ill patients, are required to validate our findings. It would really be very useful if these routine, time-tested, and feasible biochemical parameters were validated to be prognostic markers in severely ill COVID-19 patients.", "texts": ["BackgroundPrognostication plays a pivotal role in critical care medicine. Its importance is indisputable in the management of coronavirus disease 2019 (COVID-19), as the presentation of this disease may vary from docile, self-limiting symptoms to lethal conditions.\u00a0Amid the COVID-19 pandemic, much emphasis was initially placed on molecular and serological testing. However, it was\u00a0realized later that routine laboratory tests also\u00a0provide\u00a0key information in terms of the severity of the disease and thus could be used to predict the outcome of these patients.MethodologyThe aim of our study was to evaluate the biochemical parameters as prognostic markers in severely ill COVID-19 patients. We carried out a retrospective, case-control study. The study population was comprised of all severely ill COVID-19 patients\u00a0admitted between October 2020 and January 2021 at our level 3\u00a0COVID hospital.\u00a0Cases were defined as the patients who expired despite treatment and all resuscitative measures as per the standard operating procedures (SOPs) of our COVID intensive care unit (ICU)\u00a0while controls were defined as the patients that were transferred out of the COVID\u00a0ICU for further recovery. The detailed history, findings of physical examination, vitals recorded by point of care testing (POCT) devices at our ICU, clinical diagnosis, and the results of the biochemical analysis\u00a0were recorded in a specially designed pro forma. The biochemical parameters recorded at the time of admission\u00a0were compared between the groups of controls and cases in order to evaluate their role as predictors of mortality using appropriate statistical methods. P-values less than 0.05 were considered statistically significant. For all the parameters that showed a statistically significant difference, receiver operating characteristics (ROC) analysis was done\u00a0to assess the utility of biochemical parameters as predictors of mortality or survival. Areas under the curve (AUCs) of 0.6 to 0.7, 0.7 to 0.8,\u00a00.8 to 0.9, and >0.9 were considered\u00a0acceptable,\u00a0fair,\u00a0good, and\u00a0excellent for discrimination, respectively.ResultsOf the 178 severely ill COVID-19 patients enrolled in the study,\u00a086 were controls and 92 were cases .\u00a0Serum urea (p<0.0001), creatinine (p=0.0019), aspartate transaminase (AST) (p=0.0104), lactate dehydrogenase (LDH) (p=0.0001), procalcitonin (PCT)\u00a0(p=0.0344), and interleukin 6 (IL-6) (p=0.0311) levels were significantly higher (p<0.05), while total protein (p=0.0086), albumin\u00a0(p<0.0001), and indirect bilirubin\u00a0(p=0.0147) levels were significantly lower\u00a0(p<0.05) in\u00a0cases as compared to controls. The difference was statistically insignificant\u00a0(p>0.05) for serum sodium, potassium, total and direct bilirubin, globulin, alanine transaminase (ALT), alkaline phosphatase (ALP), D-dimer, and ferritin. On ROC analysis, urea was fair (AUC=0.721), creatinine (AUC=0.698) and IL-6 (AUC=0.698) were acceptable predictors of mortality, while albumin (AUC=0.698) was an acceptable predictor of survival in severely ill COVID-19 patients during their intensive care stay.ConclusionUnderstanding the pathophysiological changes associated with the severity of COVID-19 in terms of an alteration of biochemical parameters is a pressing priority.\u00a0Our study highlights the importance of routine laboratory tests in predicting outcomes in severely ill COVID-19 patients. Prognostication plays a crucial role in the management of coronavirus disease COVID-19) 9 1-8]. . 8]. It . . 8]. ICOVID-19 is an infectious disease caused by severe acute respiratory syndrome (SARS ) coronavirus 2 (CoV-2)\u00a0,4. MortaLaboratory tests are particularly useful in validating a diagnosis, predicting disease severity, and monitoring disease progression in patients with infectious diseases like COVID-19 -18. TimeAn observational, retrospective, case-control study\u00a0was conducted after obtaining approval from the Institutional Ethics Committee (IEC) of Shri Ram Murti Smarak Institute of Medical Sciences. We utilized data from all the patients admitted to the\u00a0COVID\u00a0intensive care unit (ICU) of our hospital,\u00a0Shri Ram Murti Smarak (SRMS) Institute of Medical Sciences (IMS), Bareilly, Uttar Pradesh, India, from 1st October 2020 to 31st January 2021. As per the standard operating procedures (SOPs) of our institute, patients with clinical syndromes associated with COVID-19 infection (referred\u00a0from the emergency department or wards of other departments) were admitted to our COVID ICU. These patients were screened (based on the following inclusion and exclusion criteria) for their eligibility as study participants .\u00a0Only seThe following diagnostic definitions were used to define severely ill COVID-19 patients:1. COVID-19 PatientsDefined as patients with clinical syndromes associated with COVID-19, who tested positive for either real-time-polymerase chain reaction (RT-PCR) TrueNat or Rapid Antigen Test (RAT) for COVID-19 ,17.2. Severely Ill COVID-19 PatientsOur ICU follows the \"Revised Guidelines on Clinical Management of COVID-19\", issued by the Government of India Ministry of Health & Family Welfare Directorate General of Health Services (EMR Division) to define severely ill COVID-19 patients ,16,18,192) less than 90 percent (%) on room air [(A)\u00a0Severe pneumonia: Defined as a patient suspected of having respiratory tract infection, with one or more of the following: 1) Respiratory rate greater than 30 breaths per minute; 2) Severe respiratory distress; 3) Peripheral capillary oxygen saturation  less than 200 (millimeters of mercury) mmHg or fraction of inspired oxygen (FiO2) less than or equal to 300 mmHg (with positive end-respiratory pressure (PEEP) or continuous positive airway pressure (CPAP) more than or equal to 5 centimeters (cm) of water (H2O)); (b) When PaO2 is not available, SpO2\u00a0or FiO2 less than or equal to 315; (c) Respiratory distress in non-ventilated patients [(B) Acute respiratory distress syndrome (ARDS): Defined as follows: 1) The development of new or worsening respiratory symptoms within one week of known exposure; 2) Bilateral opacities\u00a0not\u00a0explained by chest imaging studies; 3) Respiratory failure caused by factors other than\u00a0cardiac failure or fluid overload; 4) Mild, moderate or severe ARDS: Defined as (a) Partial pressure of oxygen in arterial blood  Sepsis: Defined as a dysregulated host response to infection resulting in\u00a0life-threatening organ dysfunction, diagnosed by: 1) Symptoms like altered mental status, difficult or fast breathing, or skin mottling; 2) Signs like low oxygen saturation, reduced urine output, fast heart rate, weak pulse, cold extremities or low blood pressure;\u00a03) Laboratory evidence like\u00a0coagulopathy, thrombocytopenia, acidosis, high lactate, or hyperbilirubinemia\u00a0,18,19.(D) Septic shock: Defined as persisting hypotension despite appropriate volume resuscitation, requiring vasopressors in order to maintain mean arterial pressure (MAP) more than or equal to 65 mmHg and serum lactate level less than 2 mmol/L\u00a0,16,18,19We excluded the following patients from our study: 1) Suspected cases of COVID-19 with no confirmatory laboratory results; 2) Laboratory confirmed COVID-19 cases that do not meet our criteria for severely ill COVID-19 patients; 3) Patients with insufficient data for further analysis, who denied the standard treatment protocol of our hospital or discharged against medical advice.Admission, history-taking, physical examination, analysis (done either by point of care testing (POCT) devices at the ICU or autoanalyzers at the laboratory), and management of all patients were done following the SOPs\u00a0of our institute. Data required for the study were retrieved from patients\u2019 clinical case files archived at the COVID ICU and our laboratory and hospital information systems (LIS and HIS), version 3. These endogenous information systems were developed by professionals of our engineering college  in 2017. Patients\u2019 clinical profiles  and laboratory results of blood samples collected at the time of admission to the COVID ICU were recorded in an especially designed pro forma. All the biochemical parameters , aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP), lactate dehydrogenase (LDH), urea, creatinine, sodium (Na+), and potassium (K+)) were analyzed in the biochemistry section while D-dimer and procalcitonin (PCT) estimation was done at the pathology section of our Central Clinical Laboratory. Serum interleukin-6 (IL-6) and ferritin levels were measured in the Chemiluminescence Immunoassay (CLIA) section of our Central Research Laboratory. All parameters were analyzed following the SOPs of the respective sections of our laboratories. Table We categorized the data of the subjects based on their outcome (Survivors or Non-survivors) during their stay in the\u00a0ICU. The survivors were designated as the control group\u00a0while the non-survivors were the case group. We compared the results of the blood samples collected at the time of admission to the COVID ICU between the controls\u00a0and cases to study the role of these biochemical markers in the prediction of mortality in severely ill COVID-19 patients.Categorical variables were described as frequency and percentages using demographics and continuous variables as mean and standard deviation (SD). Quantitative data were assessed for linearity using Kolmogorov-Smirnov analysis and tests of statistical significance (student\u2019s unpaired t-test or Mann-Whitney-U test) were used depending upon the data type. Means for continuous variables were compared using independent group p-values in MedCalc software. The parameters with p-values less than 0.05 were considered statistically significant. Receiver operating characteristics (ROC) curve analysis was utilized  to assess the utility of biochemical parameters to predict mortality or survival. AUC of 0.6 to 0.7, 0.7 to 0.8,\u00a00.8 to 0.9, and >0.9 were considered\u00a0acceptable,\u00a0fair,\u00a0good, and\u00a0excellent discrimination, respectively. Further, for all parameters with an AUC > 0.6, the sensitivity and specificity\u00a0as\u00a0predictors of survival or mortality (at specific cut-offs) were also\u00a0assessed on the basis of the ROC analysis.Out of 231 critically ill patients admitted to our COVID ICU between October\u00a0and January\u00a02021, 178 severely ill COVID-19 patients were enrolled in the present study (based on our inclusion). We excluded\u00a053\u00a0patients  based on our exclusion criteria. Out of 178 patients enrolled in the study, 134 (75.28%) were males and 44 (24.72%) were females. The youngest patient was 14 years old and the oldest patient was 97 years old, while the average age was found to be 62 years. The greatest number of patients (74.72%) belonged to the age group of 51-80 years.\u00a0Figure We categorized\u00a0178 patients enrolled in our study\u00a0based on their outcomes (survivors or Non-survivors) during their stay in the ICU. Table The biochemical parameters\u00a0showed statistically significant differences (p<0.05)\u00a0in their average values\u00a0between the cases and controls groups. A statistically significant difference was observed for serum urea (p<0.0001), creatinine (p=0.0019), indirect bilirubin (p=0.0147), serum protein (p=0.0086), albumin (p<0.0001), AST (p=0.0104), LDH (p=0.0001), PCT p=0.0344), and IL-6 (p=0.0311)  curves were plotted for all the parameters that showed a statistically significant difference between the cases and controls. Below, we are reporting only the results of the ROC curve analysis for the parameters that were found to be predictors of mortality or survival based on AUC Table .The ROC curve for serum urea and serum creatinine as predictors of mortality has an area under the curve (AUC) of 0.721 (fair predictor) and 0.698 (acceptable), respectively. For a cut-off value of 52 mg/dl for serum urea, the sensitivity and specificity are 0.736 and 0.605, respectively, while for a cut-off value of 0.95 mg/dl for serum creatinine level, the sensitivity and specificity are 0.747 and 0.605, respectively, as a predictor of mortality\u00a0, which puts it at the upper bounds of an acceptable score. For a cut-off value of 44.41 pg/ml of serum IL-6, the sensitivity and specificity are 0.703 and 0.605, respectively, as a predictor of mortality\u00a0, which puts it at the upper bounds of an acceptable score. For a cut-off value of 3.25 g/dl of serum albumin, the sensitivity and specificity are 0.767 and 0.593, respectively, as predictors of survival\u00a0Figure .In our study, critically ill COVID-19 patients showed distinct clinical, demographic, and laboratory features at the time of\u00a0ICU\u00a0admission. It was observed that men are more affected by COVID-19 in terms of both morbidity and mortality. Previous studies showed that this could be due to the expression of more angiotensin-converting enzyme 2 (ACE2) receptors in men than in women . MoreoveSerum urea (p<0.0001),creatinine (p=0.0019), AST\u00a0(p=0.0104), LDH\u00a0(p=0.0001), procalcitonin (PCT)\u00a0(p=0.0344), and IL-6\u00a0(p=0.0311) levels were significantly higher (p<0.05) while total protein (p=0.0086), albumin\u00a0(p<0.0001), and indirect bilirubin\u00a0(p=0.0147) levels were significantly lower\u00a0(p<0.05) in\u00a0cases as compared to controls.The difference was statistically insignificant\u00a0(p>0.05) for serum sodium, potassium, total and direct bilirubin, globulin, ALT, ALP, D-dimer, and ferritin.Abnormal renal function tests (higher levels of serum urea and creatinine) were reported in our study and the difference was found to be highly significant (urea (p<0.0001) and creatinine (p=0.0019)) between the controls and cases. The ROC\u00a0curve for\u00a0urea AUC=0.721) and creatinine (AUC=0.698) were found to be fair and acceptable predictors of mortality, respectively. For a cut-off value of 52 mg/dl for\u00a0urea level, the sensitivity and specificity are 0.736 and 0.605, respectively, while for a cut-off value of 0.95 mg/dl for\u00a0creatinine level, the sensitivity and specificity were 0.747 and 0.605, respectively\u00a0 was found to be statistically insignificant . Many of these  are reported to have good prognostic value in several studies .Based on the findings of our study, we propose biochemical parameters as practical prognostic markers in severely ill COVID-19 patients due to the routine practice of their monitoring (owing to their easy availability) in these patients.We assume that the manifestation of clinical syndromes associated with severe COVID-19 is the actual time when the development of metabolic alterations responsible for death in severely ill COVID-19 patients is triggered. Based on this, we postulate that prognosticating at this triggering moment has to be both\u00a0sensitive and specific ,16,18,19Based on the observations of this study, we believe that routine biochemistry parameters can be used as feasible prognostic markers in severely ill COVID-19 patients. With the help of easily available prognostic markers, COVID-19 patients at higher risk of poor outcomes can be appropriately managed\u00a0-9. With The main strength of this study is its planning and execution at an ICU known for its quality services and adherence to SOPs and protocols. The well-planned study , the inclusion of results of the investigation done at the time of identification of clinical syndromes associated with severe COVID-19 in all study participants, and the quantitative analysis of all biochemical parameters using cutting-edge methods\u00a0are some of the positive aspects of our study ,18,19,27The main limitation of this study\u00a0is its retrospective design. However, we assume that the accuracy of the findings is acceptable, as we followed the SOPs prevalent in our institute for both biochemical\u00a0investigations\u00a0as well as the management of all patients enrolled in the study. The limited sample size and\u00a0inclusion of patients with pre-existing diseases (including those who required invasive ventilation) are the major limitations. Studies with a larger sample size, with a special emphasis on understanding the role of other factors  on the biochemical profile of these patients and their correlation with adverse outcomes are direly needed. A study of these biochemical parameters in mild and moderate cases\u00a0of COVID-19 as well would provide a better understanding of these biochemical alterations and their relation to the development of severe illness. Understanding these biochemical alterations would not only\u00a0help in prognosticating the risk of development of severe illness but also guide the development of better treatment protocols ,19,28,29Renal dysfunction (elevated levels of serum urea and\u00a0creatinine) and elevated serum IL-6 levels but lower serum albumin levels were found to be the best prognostic markers of in-hospital mortality of severely ill COVID-19 patients in our study population.\u00a0We propose that the vigilant monitoring of these biochemical parameters can aid in the prognostication of COVID-19 and thus improve the clinical management of these high-risk patients. However, large\u2010scale, multicenter studies designed to evaluate the prognostic utility of these parameters in the prognostication of COVID-19, especially in severely ill patients, are required to validate our findings. It would really be very useful if these routine, time-tested, and feasible biochemical parameters were validated to be prognostic markers in severely ill COVID-19 patients."]}
{"representative": "Here, we walk through how the discrete, next generation process connects to the ordinary differential equation disease system of interest, linearized at the disease-free equilibrium. Then, we use linear algebra to develop a geometric explanation of why the spectral radius of the next generation matrix is an epidemic threshold. Finally, we work through a series of examples that help to build familiarity with the kinds of patterns that arise in parameter combinations produced by the next generation method. This article is intended to help new infectious disease modelers develop intuition for the form and interpretation of the basic reproduction number in their disease systems of interest.The basic reproduction number  The basic reproduction number for epidemic models, denoted The reader is assumed to have at least an introductory knowledge of differential equations and linear algebra. While a knowledge of linear algebra is not, strictly speaking, necessary to understand, develop, or simulate an epidemic model, it is both convenient for many analyses and necessary for developing a deeper understanding of the modeled disease systems. For students starting to explore infectious disease modeling, it is important to recognize that knowing how to invert and multiply matrices as one might in a basic linear algebra class does not necessarily translate into an understanding of what the quantities mean, and that having a heuristic understanding of the epidemiological concepts is not always enough to be confident in the mathematical techniques. In this paper, we break down the basic reproduction number and develop an understanding of it using basic linear algebra concepts. Then, we examine a series of simple models to understand why common patterns arise in the parameter combinations representing The basic reproduction number ion\u00a0Fine .Mathematical modeling is often used to estimate the basic reproductive number for a disease system; in fact, the basic reproduction number is widely considered the most useful contribution of mathematics to epidemiology. Epidemic models are a class of models that represent disease processes\u2014chiefly transmission and recovery, but possibly others\u2014in mathematical form. There are many resources available for those interested in infectious disease modeling more broadly\u00a0 who are susceptible (S) to disease, who are infectious (I), and who have recovered (R) over time t. This model has two parameters, the transmission rate S/N, in the rate. Recovery is a more straightforward process and is modeled as a linear rate N; the density-dependent form of the equations, in which the transmission term is given by The most basic epidemic model is the ODE, compartmental SIR model\u00a0. The threshold of In epidemic models, the basic reproduction number acts as a threshold value that controls the local stability of the disease-free equilibrium: if mentclass2pt{minimeffective reproduction number, S(t)/N needs to be accounted for. When working with infectious disease interventions, we are often trying to get The approximations that we made to think through the intuition for \u00a0Boumans . Essentiherd protection\u00a0 but will need to vaccinate almost everyone for very infectious disease, like measles (which requires upwards of 95% coverage). Vaccine hesitancy is a big concern to many people in public health, because diseases that were once virtually eradicated can regain a foothold when coverage dips too low, even locally. Population assortativity, which describes the situation where people are more likely to contact others with similar demographic characteristics , can result in lower-than-expected levels of herd protection because the well-mixed assumptions that underlie the above equations are violated\u00a0. Then, the disease-free equilibrium is the point in state space where all individuals are susceptible, denoted i, let i. Let i minus the rate of transfer into compartment i. ThenF and V be the Jacobian matrix  of F and V can be used to succinctly write the equations for the infected compartments in the ODE linearized at the disease-free equilibrium,Several methods exist for calculating the mentclass2pt{minimk of a disease-free population. The  entry of j during its lifetime, assuming that the population remains near the DFE and barring reinfection. The  entry of F is the rate at which infected individuals in compartment j produce new infections in compartment i. Hence, the  entry of the product i produced by the infected individual originally introduced into compartment k.To interpret the entries of The basic reproduction number is defined to be the spectral radius\u2014that is, the magnitude of the largest eigenvalue\u2014of the matrix K can be found by solving the characteristic equation I is the identity matrix the same size as K. An important feature of K is that all entries are nonnegative; this implies , then there are no nonnegative eigenvectors other than K is reducible, then there may be degenerate initial conditions).The matrix em\u00a0Meyer ) that K\u2019The next generation theorem tells us that our continuous ODE system is stable (no outbreak) if and only if M individuals across m infected compartments at the start of an epidemic, i.e., m infected compartments in the next generation, i.e., all of the individuals that were infected by the individuals in A for a disease system with two infectious compartments, say adults and children, respectively,A, i.e., the nth generation is Let x(t) is the vector of the number of people in each infected compartment over time.While it makes intuitive sense that we should expect an outbreak when the next generation of infected individuals is larger than the previous generation, it may be less obvious how this discrete process corresponds to our original continuous ODE model. To understand the connection, it is important to first remember that our goal is not to find an alternate, discrete approach to simulating the disease system. Instead, our goal is to determine the threshold that controls the stability of the ODE system near the disease-free equilibrium, that is, find the threshold that determines whether or not there will be an outbreak. To that end, let\u2019s consider the linearized ODE disease system near the disease free-equilibrium. As we saw in Sect.\u00a0t who were part of the nth generation. Then, x(t), the vector of the number of individuals in each of the infected compartments over time, regardless of generation, is the sum over all of the generations, n, irrespective of when they were infected. It is calculated as the cumulative number of people in the nth generation entering each infected class, namely Now, let\u2019s distinguish between each generation in our ODE model, beginning with the initial generation K is not a substitute for the ODE system; instead the next generation matrix should be seen as an interpretable object that tells us whether we expect an outbreak for a given disease system.It is important to emphasize that this discussion is in the context of the linearized ODE system near the disease-free equilibrium. Because nonlinear ODE epidemic models quickly leave this regime, we should not expect the behavior of those trajectories to match these iterations of the next generation matrix. Hence, applying the next generation matrix K is the key threshold for the stability of these epidemic models.Although we now understand how using the next generation matrix as a linear process relates to the dynamics of our disease system, we still need to answer the question of why the spectral radius of K is the magnitude of the largest eigenvalue of K. To understand why the spectral radius is important, let us consider a geometric interpretation of an eigenvalue K. Recall that an eigenvalue A defined in Eq.\u00a0 with radius M, i.e., the set of all vectors M. Although most of us are most familiar with the M has a diamond shape in M. In the Why are these eigenvalues and eigenvectors important? Let\u2019s take a step back and consider the space of all possible initial generations M individuals partitioned into m infected compartments, K by matrix multiplication to a vector K to every vector in M, the size of each A given in Eq.\u00a0 and  by the same amount, K is called the operator norm of K and is denoted Now, we have the set of all possible initial generation vectors mentclass2pt{minimK to the set of initial generation vectors n times. This process calculates the size of the nth generation of infected people and the distribution of the individuals among the m infected classes. The original shape becomes more exaggerated as the size of the subsequent generations increases. Iterations of this process tell us about the long-term behavior of the system linearized at the disease-free equilibrium for each possible initial condition  by a factor of K gives the expected size of an average next generation and why this basic reproduction number determines the stability of our ODE disease system near the disease-free equilibrium.How many new infections are in a new generation when we are near this stable distribution represented by mentclass2pt{minim(K) Fig.\u00a0, using tA given in Eq.\u00a0 and A to subsequent generations of infected individuals, these generations will converge toward a stable distribution of adults and children infected in each next generation. By normalizing the eigenvector corresponding to the largest eigenvalue, we can see that the distribution of new infections converges to 2/3 adults and 1/3 children. Regardless of initial distribution, the system moves to a stable distribution of new infections of both types, with an average of 2 new infections per infected individual overall.Let\u2019s visualize the geometric interpretation of the next generation matrix in a few concrete examples. First, let\u2019s revisit the next generation matrix n in Eq.\u00a0. BecauseA. Note that although we show the transformation on the full unit circle, we are primarily interested in the behavior in the first quadrant, In Fig.\u00a0mentclass2pt{minimmentclass2pt{minimmentclass2pt{minimB has eigenvalues 1.6 and 0.7, and we expect an outbreak. Matrix C, has eigenvalues 0.8 and 0.7, so, despite the fact that infections of type 2 produce an average of C is not irreducible because infections of type 1 cannot make infections of type 2, which is why C can have two nonnegative eigenvectors. But, one of these eigenvectors corresponds to a degenerate initial condition . All other initial conditions converge to the eigenvector associated with B and C.We repeat this exercise with two more matrices:One challenge in working with basic reproduction numbers calculated from the next generation method\u2014particularly when using symbolic calculators\u2014is interpreting and developing intuition for the form of Here, we explore the calculation and interpretation of entclass1pt{minimaentclass1pt{minimaentclass1pt{minimaentclass1pt{minimaL, which tracks the number of people with latent infections, who are not yet infectious . A second extension is to include vital dynamics, i.e., birth and death, here represented by the parameter L and I. We writeF and V with respect to L and I and evaluate them at the disease-free equilibrium, where ith component of the diagonal of V is rate of leaving compartment i . The other elements in the corresponding column are the rates of movement to the other infected compartments. The sum of a column gives the rate of becoming not infected (whether through recovery or death). Then,I given a person in either L or I near the disease-free equilibrium. Any new infections produce latent people, not infectious people directly.One simple extension of the SIR model is the SLIR model, in which we add a compartment The next generation matrix has two eigenvalues, 0 andWhen modeling many diseases, we often consider direct, person-to-person transmission, captured by the familiar S, I, and R compartments. We additionally track the concentration of pathogens in the water system W. In this model, people become infectious not through contact with one another but by drinking the water. People drink people getting infected, we do not treat pathogens shedding into the water . Each class of host only transmits the disease to the other class and not directly to other members of their own class .Here, we use a very simple model with two classes of individuals (1 and 2), each of which can be S, I, or R. Infectious members of each class transmit only to the other class with rates K, we can seeTo start with, let\u2019s continue with the vectorborne example, and writeK. Indeed, the reader might like to explore how the formula for But what if we care about new infections in both classes? We have to rewriteDespite having different interpretations, both of the F and Because there is not always a single valid interpretation, it is worth asking how we know whether a choice to include a term in Watmough , but a dIn this final example, we address a common challenge that arises in interpreting I represents untreated infected individuals, and T represents treated infected individuals. We can think of this as a simplified model of treatment compliance. Here, treatment might reduce infectiousness and reduce the mortality rate. Parameters V, namely For the purposes of illustration, we use a very simple model with two classes of infected people with bidirectional movement. Here, X, a random number, be the number of visits to compartment I, and let Z be the event of a return visit to compartment I. Using the law of total expectationE[X], we getV can be similarly understood.Consider an individual with an untreated infection. They can either die with probability A be the matrix whose entries j to compartment i; this is the adjacency matrix of the directed graph of the compartments, weighted by transition probability . Theni if one starts in compartment j. Thus, we can write There is a graph-theoretic way of approaching this interpretation as well\u00a0(Brouwer et\u00a0al. The basic reproduction number", "texts": ["Here, we walk through how the discrete, next generation process connects to the ordinary differential equation disease system of interest, linearized at the disease-free equilibrium. Then, we use linear algebra to develop a geometric explanation of why the spectral radius of the next generation matrix is an epidemic threshold. Finally, we work through a series of examples that help to build familiarity with the kinds of patterns that arise in parameter combinations produced by the next generation method. This article is intended to help new infectious disease modelers develop intuition for the form and interpretation of the basic reproduction number in their disease systems of interest.The basic reproduction number  The basic reproduction number for epidemic models, denoted The reader is assumed to have at least an introductory knowledge of differential equations and linear algebra. While a knowledge of linear algebra is not, strictly speaking, necessary to understand, develop, or simulate an epidemic model, it is both convenient for many analyses and necessary for developing a deeper understanding of the modeled disease systems. For students starting to explore infectious disease modeling, it is important to recognize that knowing how to invert and multiply matrices as one might in a basic linear algebra class does not necessarily translate into an understanding of what the quantities mean, and that having a heuristic understanding of the epidemiological concepts is not always enough to be confident in the mathematical techniques. In this paper, we break down the basic reproduction number and develop an understanding of it using basic linear algebra concepts. Then, we examine a series of simple models to understand why common patterns arise in the parameter combinations representing The basic reproduction number ion\u00a0Fine .Mathematical modeling is often used to estimate the basic reproductive number for a disease system; in fact, the basic reproduction number is widely considered the most useful contribution of mathematics to epidemiology. Epidemic models are a class of models that represent disease processes\u2014chiefly transmission and recovery, but possibly others\u2014in mathematical form. There are many resources available for those interested in infectious disease modeling more broadly\u00a0 who are susceptible (S) to disease, who are infectious (I), and who have recovered (R) over time t. This model has two parameters, the transmission rate S/N, in the rate. Recovery is a more straightforward process and is modeled as a linear rate N; the density-dependent form of the equations, in which the transmission term is given by The most basic epidemic model is the ODE, compartmental SIR model\u00a0. The threshold of In epidemic models, the basic reproduction number acts as a threshold value that controls the local stability of the disease-free equilibrium: if mentclass2pt{minimeffective reproduction number, S(t)/N needs to be accounted for. When working with infectious disease interventions, we are often trying to get The approximations that we made to think through the intuition for \u00a0Boumans . Essentiherd protection\u00a0 but will need to vaccinate almost everyone for very infectious disease, like measles (which requires upwards of 95% coverage). Vaccine hesitancy is a big concern to many people in public health, because diseases that were once virtually eradicated can regain a foothold when coverage dips too low, even locally. Population assortativity, which describes the situation where people are more likely to contact others with similar demographic characteristics , can result in lower-than-expected levels of herd protection because the well-mixed assumptions that underlie the above equations are violated\u00a0. Then, the disease-free equilibrium is the point in state space where all individuals are susceptible, denoted i, let i. Let i minus the rate of transfer into compartment i. ThenF and V be the Jacobian matrix  of F and V can be used to succinctly write the equations for the infected compartments in the ODE linearized at the disease-free equilibrium,Several methods exist for calculating the mentclass2pt{minimk of a disease-free population. The  entry of j during its lifetime, assuming that the population remains near the DFE and barring reinfection. The  entry of F is the rate at which infected individuals in compartment j produce new infections in compartment i. Hence, the  entry of the product i produced by the infected individual originally introduced into compartment k.To interpret the entries of The basic reproduction number is defined to be the spectral radius\u2014that is, the magnitude of the largest eigenvalue\u2014of the matrix K can be found by solving the characteristic equation I is the identity matrix the same size as K. An important feature of K is that all entries are nonnegative; this implies , then there are no nonnegative eigenvectors other than K is reducible, then there may be degenerate initial conditions).The matrix em\u00a0Meyer ) that K\u2019The next generation theorem tells us that our continuous ODE system is stable (no outbreak) if and only if M individuals across m infected compartments at the start of an epidemic, i.e., m infected compartments in the next generation, i.e., all of the individuals that were infected by the individuals in A for a disease system with two infectious compartments, say adults and children, respectively,A, i.e., the nth generation is Let x(t) is the vector of the number of people in each infected compartment over time.While it makes intuitive sense that we should expect an outbreak when the next generation of infected individuals is larger than the previous generation, it may be less obvious how this discrete process corresponds to our original continuous ODE model. To understand the connection, it is important to first remember that our goal is not to find an alternate, discrete approach to simulating the disease system. Instead, our goal is to determine the threshold that controls the stability of the ODE system near the disease-free equilibrium, that is, find the threshold that determines whether or not there will be an outbreak. To that end, let\u2019s consider the linearized ODE disease system near the disease free-equilibrium. As we saw in Sect.\u00a0t who were part of the nth generation. Then, x(t), the vector of the number of individuals in each of the infected compartments over time, regardless of generation, is the sum over all of the generations, n, irrespective of when they were infected. It is calculated as the cumulative number of people in the nth generation entering each infected class, namely Now, let\u2019s distinguish between each generation in our ODE model, beginning with the initial generation K is not a substitute for the ODE system; instead the next generation matrix should be seen as an interpretable object that tells us whether we expect an outbreak for a given disease system.It is important to emphasize that this discussion is in the context of the linearized ODE system near the disease-free equilibrium. Because nonlinear ODE epidemic models quickly leave this regime, we should not expect the behavior of those trajectories to match these iterations of the next generation matrix. Hence, applying the next generation matrix K is the key threshold for the stability of these epidemic models.Although we now understand how using the next generation matrix as a linear process relates to the dynamics of our disease system, we still need to answer the question of why the spectral radius of K is the magnitude of the largest eigenvalue of K. To understand why the spectral radius is important, let us consider a geometric interpretation of an eigenvalue K. Recall that an eigenvalue A defined in Eq.\u00a0 with radius M, i.e., the set of all vectors M. Although most of us are most familiar with the M has a diamond shape in M. In the Why are these eigenvalues and eigenvectors important? Let\u2019s take a step back and consider the space of all possible initial generations M individuals partitioned into m infected compartments, K by matrix multiplication to a vector K to every vector in M, the size of each A given in Eq.\u00a0 and  by the same amount, K is called the operator norm of K and is denoted Now, we have the set of all possible initial generation vectors mentclass2pt{minimK to the set of initial generation vectors n times. This process calculates the size of the nth generation of infected people and the distribution of the individuals among the m infected classes. The original shape becomes more exaggerated as the size of the subsequent generations increases. Iterations of this process tell us about the long-term behavior of the system linearized at the disease-free equilibrium for each possible initial condition  by a factor of K gives the expected size of an average next generation and why this basic reproduction number determines the stability of our ODE disease system near the disease-free equilibrium.How many new infections are in a new generation when we are near this stable distribution represented by mentclass2pt{minim(K) Fig.\u00a0, using tA given in Eq.\u00a0 and A to subsequent generations of infected individuals, these generations will converge toward a stable distribution of adults and children infected in each next generation. By normalizing the eigenvector corresponding to the largest eigenvalue, we can see that the distribution of new infections converges to 2/3 adults and 1/3 children. Regardless of initial distribution, the system moves to a stable distribution of new infections of both types, with an average of 2 new infections per infected individual overall.Let\u2019s visualize the geometric interpretation of the next generation matrix in a few concrete examples. First, let\u2019s revisit the next generation matrix n in Eq.\u00a0. BecauseA. Note that although we show the transformation on the full unit circle, we are primarily interested in the behavior in the first quadrant, In Fig.\u00a0mentclass2pt{minimmentclass2pt{minimmentclass2pt{minimB has eigenvalues 1.6 and 0.7, and we expect an outbreak. Matrix C, has eigenvalues 0.8 and 0.7, so, despite the fact that infections of type 2 produce an average of C is not irreducible because infections of type 1 cannot make infections of type 2, which is why C can have two nonnegative eigenvectors. But, one of these eigenvectors corresponds to a degenerate initial condition . All other initial conditions converge to the eigenvector associated with B and C.We repeat this exercise with two more matrices:One challenge in working with basic reproduction numbers calculated from the next generation method\u2014particularly when using symbolic calculators\u2014is interpreting and developing intuition for the form of Here, we explore the calculation and interpretation of entclass1pt{minimaentclass1pt{minimaentclass1pt{minimaentclass1pt{minimaL, which tracks the number of people with latent infections, who are not yet infectious . A second extension is to include vital dynamics, i.e., birth and death, here represented by the parameter L and I. We writeF and V with respect to L and I and evaluate them at the disease-free equilibrium, where ith component of the diagonal of V is rate of leaving compartment i . The other elements in the corresponding column are the rates of movement to the other infected compartments. The sum of a column gives the rate of becoming not infected (whether through recovery or death). Then,I given a person in either L or I near the disease-free equilibrium. Any new infections produce latent people, not infectious people directly.One simple extension of the SIR model is the SLIR model, in which we add a compartment The next generation matrix has two eigenvalues, 0 andWhen modeling many diseases, we often consider direct, person-to-person transmission, captured by the familiar S, I, and R compartments. We additionally track the concentration of pathogens in the water system W. In this model, people become infectious not through contact with one another but by drinking the water. People drink people getting infected, we do not treat pathogens shedding into the water . Each class of host only transmits the disease to the other class and not directly to other members of their own class .Here, we use a very simple model with two classes of individuals (1 and 2), each of which can be S, I, or R. Infectious members of each class transmit only to the other class with rates K, we can seeTo start with, let\u2019s continue with the vectorborne example, and writeK. Indeed, the reader might like to explore how the formula for But what if we care about new infections in both classes? We have to rewriteDespite having different interpretations, both of the F and Because there is not always a single valid interpretation, it is worth asking how we know whether a choice to include a term in Watmough , but a dIn this final example, we address a common challenge that arises in interpreting I represents untreated infected individuals, and T represents treated infected individuals. We can think of this as a simplified model of treatment compliance. Here, treatment might reduce infectiousness and reduce the mortality rate. Parameters V, namely For the purposes of illustration, we use a very simple model with two classes of infected people with bidirectional movement. Here, X, a random number, be the number of visits to compartment I, and let Z be the event of a return visit to compartment I. Using the law of total expectationE[X], we getV can be similarly understood.Consider an individual with an untreated infection. They can either die with probability A be the matrix whose entries j to compartment i; this is the adjacency matrix of the directed graph of the compartments, weighted by transition probability . Theni if one starts in compartment j. Thus, we can write There is a graph-theoretic way of approaching this interpretation as well\u00a0(Brouwer et\u00a0al. The basic reproduction number"]}
{"representative": "This is a retrospective report of the frequency of severe hypoglycemia and the association between common mental disorders and type 1 diabetes mellitus treated with insulin analogues. Patients with severe hypoglycemia compared with those without this complication had a higher prevalence of positive screening for common mental disorders . Intensive treatment of type 1 diabetes (T1D) prevents and slows the progression of long-term complications of the disease, but severe hypoglycemia is a barrier in achieving strict glucose control in these patients  and incrThe purpose of this study was to evaluate the frequency of severe hypoglycemia and its association with common mental disorders in patients with T1D treated with insulin analogues after introduction of these types of insulin in the public health system in Southern Brazil.To evaluate the aspects highlighted above, we studied 516 adults with T1D living across 38 cities in Southern Brazil. The patients included in this study were selected from participants in a program of no-cost distribution of insulin analogues, whose enrollment in Brazil requires at least two severe hypoglycemic events within a period of 6 months. Severe hypoglycemia, defined as hypoglycemic episodes requiring assistance from another person, was evaluated using a self-report questionnaire. The eligible population included patients aged 18 years or older who were using short-acting insulin analogues  and/or long-acting insulin analogues . Patients with cognitive deficits or communication barriers were excluded.Treatment satisfaction was evaluated using the Diabetes Treatment Satisfaction Questionnaire status version (DTSQs). The total DTSQs score varied from 0 to 36, with higher scores indicating greater treatment satisfaction , previously validated in the Brazilian population . The queHospital de Cl\u00ednicas de Porto Alegre (Certificado de Apresenta\u00e7\u00e3o para Aprecia\u00e7\u00e3o \u00c9tica [CAAE] 1.283.728).The protocol of the present study was approved by the Research Ethics Committee of vs. 77%, respectively, p = 0.027), as well as more symptoms of depression, anxiety, somatic signs, and social withdrawal. Additionally, the median DTSQs score was lower in patients with severe hypoglycemia compared with those without this complication.The patients had a median age of 35 years (interquartile range 28-45 years) and were 52% women. In all, 101 (20%) patients reported severe hypoglycemia in the month before the data collection . All patThis study has some limitations. First, severe hypoglycemia is associated with depression , and sin", "texts": ["This is a retrospective report of the frequency of severe hypoglycemia and the association between common mental disorders and type 1 diabetes mellitus treated with insulin analogues. Patients with severe hypoglycemia compared with those without this complication had a higher prevalence of positive screening for common mental disorders . Intensive treatment of type 1 diabetes (T1D) prevents and slows the progression of long-term complications of the disease, but severe hypoglycemia is a barrier in achieving strict glucose control in these patients  and incrThe purpose of this study was to evaluate the frequency of severe hypoglycemia and its association with common mental disorders in patients with T1D treated with insulin analogues after introduction of these types of insulin in the public health system in Southern Brazil.To evaluate the aspects highlighted above, we studied 516 adults with T1D living across 38 cities in Southern Brazil. The patients included in this study were selected from participants in a program of no-cost distribution of insulin analogues, whose enrollment in Brazil requires at least two severe hypoglycemic events within a period of 6 months. Severe hypoglycemia, defined as hypoglycemic episodes requiring assistance from another person, was evaluated using a self-report questionnaire. The eligible population included patients aged 18 years or older who were using short-acting insulin analogues  and/or long-acting insulin analogues . Patients with cognitive deficits or communication barriers were excluded.Treatment satisfaction was evaluated using the Diabetes Treatment Satisfaction Questionnaire status version (DTSQs). The total DTSQs score varied from 0 to 36, with higher scores indicating greater treatment satisfaction , previously validated in the Brazilian population . The queHospital de Cl\u00ednicas de Porto Alegre (Certificado de Apresenta\u00e7\u00e3o para Aprecia\u00e7\u00e3o \u00c9tica [CAAE] 1.283.728).The protocol of the present study was approved by the Research Ethics Committee of vs. 77%, respectively, p = 0.027), as well as more symptoms of depression, anxiety, somatic signs, and social withdrawal. Additionally, the median DTSQs score was lower in patients with severe hypoglycemia compared with those without this complication.The patients had a median age of 35 years (interquartile range 28-45 years) and were 52% women. In all, 101 (20%) patients reported severe hypoglycemia in the month before the data collection . All patThis study has some limitations. First, severe hypoglycemia is associated with depression , and sin"]}
{"representative": "The aim of this study was to evaluate the frequency of hypoglycemia and the treatment satisfaction in patients with type 1 diabetes (T1D) using insulin analogues.This observational retrospective study included 516 adult patients with T1D from 38 cities in Southern Brazil. Demographics and clinical data were collected using a self-report questionnaire. Hypoglycemia was defined as an event based on either symptoms or self-monitored blood glucose < 70 mg/dL. Treatment satisfaction was evaluated using the Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) and with a specific question with scores ranging from 0\u201310. Common mental disorders were assessed using the General Health Questionnaire (GHQ-12).Overall, the mean age was 38 \u00b1 14 years and 52% of the participants were women. The median diabetes duration was 18 years. The scores for insulin analogue treatment satisfaction were higher than those for previous treatments. DTSQ scores had a median value of 32 (interquartile range 29\u201335) and remained unchanged over time. The percentage of patients with hypoglycemia  was comparable across groups divided according to duration of use of insulin analogues. Most patients  screened positive for common mental disorders.Patient satisfaction with insulin analogue treatment was high and remained unchanged with time. Episodes of hypoglycemia also remained unchanged over time among patients using insulin analogues. Type 1 diabetes mellitus is a chronic and progressive disease with an increasing incidence over the past decades. Estimates project that 5\u201310% of all 12 million patients with diabetes in Brazil have type 1 diabetes .The Diabetes Control and Complications Trial (DCCT) has shown that strict glycemic control in patients with diabetes significantly decreases the risk of chronic complications . After tBecause of their pharmacological profile, insulin analogues can better mimic endogenous insulin production compared with human insulin, thus contributing to a decreased frequency of hypoglycemia and improved treatment satisfaction . Some stAnother limitation in interpreting the results of studies that have associated the use of insulin analogues with better patient satisfaction with treatment is that other parameters such as depression and anxiety can also impact patient satisfaction . Indeed,In addition to the concerns regarding the potential advantages of therapy with insulin analogues, it is unclear whether patient satisfaction with this specific therapy could reduce over time, as observed with other interventions in chronic diseases . We hypoHospital de Cl\u00ednicas de Porto Alegre (Certificado de Apresenta\u00e7\u00e3o para Aprecia\u00e7\u00e3o \u00c9tica \u2013CAAE-1.283.728).This was an observational study carried out from April 2016 to December 2017. The protocol of the study was approved by the research ethics committee of The primary outcomes were the frequency of hypoglycemia and treatment satisfaction of patients with type 1 diabetes mellitus after starting treatment with insulin analogues provided by the government, seeking possible predictors of greater satisfaction and fewer hypoglycemic events. A secondary outcome was the impact of the duration of treatment with insulin analogues on the primary outcomes.The public health system in the state of Rio Grande do Sul is geographically divided into 19 regional health coordinating units. These 19 units comprehend different numbers of municipalities, totaling 498 in the entire state. To determine the locations for data collection, we first selected 19 municipalities to represent each coordinating unit. Other 21 municipalities were randomly selected to complete the number of patients necessary to represent the regional health coordination units that received insulin analogues in the state.Patients were invited to participate in the study upon their arrival at the pharmacy to pick up short- or long-acting insulin analogues dispensed by administrative or judicial procedures. A written informed consent was signed by the patients included in the study or their legal guardians.The eligible population comprised patients aged 18 years or more, with type 1 diabetes mellitus treated with short-acting  and/or long-acting  insulin analogues supplied by the Health Secretariat of Rio Grande do Sul (SES-RS) via an administrative or judicial procedure. Patients with impaired cognition or communication barriers were excluded.i.e., type 1 diabetes mellitus, use of human insulin for at least 6 months, HbA1c level < 12%, at least two severe hypoglycemic events over 6 months, and follow-up with an endocrinologist for at least 6 months. Patients who did not meet all the criteria to receive insulin analogue via an administrative procedure appealed to the judiciary to receive the medication via a judicial procedure.To receive insulin analogues via an administrative procedure, a patient is required to have certain inclusion criteria, Clinical and sociodemographic characteristics were obtained using a self-report questionnaire. For the hypoglycemic outcomes, the questionnaire referred to the month before study enrollment. Hypoglycemia was defined as an event based on either symptoms or self-monitored blood glucose < 70 mg/dL. Severe hypoglycemia was defined according to the American Diabetes Association as any hypoglycemic event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions . Nocturni.e., 0 represents \u201cnever\u201d, and 6 represents \u201cmost of the time\u201d. Scores for all DTSQs items except for items two and three were used for the total DTSQs score, which ranged from 0 to 36. Higher scores indicated greater treatment satisfaction.Treatment satisfaction was analyzed using the Portuguese version of the Diabetes Treatment Satisfaction Questionnaire status version (DTSQs), an 8-item inventory assessing therapy for type 1 diabetes mellitus in the previous weeks. This survey measures general satisfaction, adequacy, flexibility, diabetes understanding, and willingness to recommend the current treatment to other people and maintain such treatment . Each itFor mental health screening, the participants filled out the 12-item General Health Questionnaire (GHQ-12) translated into Brazilian Portuguese and validated for the Brazilian population . This seExperience with the current and previous treatments was also evaluated using a specific question with scores ranging from 0 to 10, obtained through a self-report questionnaire. Other relevant survey information, including the patients\u2019 weight (kg), height (cm), and insulin dispensing process , were collected from the SES-RS computerized drug delivery system by a trained and authorized researcher.Considering an alpha error of 5% and a confidence interval range of 8%, the sample size calculation yielded 527 individuals.Data were described using measures of central tendency  and dispersion (standard deviations and interquartile range [IQR]) for continuous variables and absolute numbers and proportions for categorical variables. Analysis of variance (ANOVA) was used for comparing numerical variables with normal distribution, and the Kruskal-Wallis test for data without normal distribution. The Mann-Whitney and Wilcoxon tests were used for paired samples, and the chi-square test was used to compare categorical variables. P values < 0.05 were considered statistically significant. All analyses were performed using the statistical software SPSS v.16.0 .From 4124 patients with type 1 diabetes mellitus older than 18 years receiving insulin analogues from SES-RS, we selected 566 potential participants. Of these, 50 were excluded for not meeting the inclusion criteria, yielding a final sample of 516 patients. The patients in the final sample belonged to 38 of the 40 municipalities included in the sample selection. The collection of data from some municipalities was difficult and we were unable to achieve 100% representation for each coordinating unit.2  was 25 \u00b1 5 kg/m2 . The med2 . RegardiAmong all patients included in the study, 350 (74%) reported hypoglycemia the month before data collection. Regarding the type of hypoglycemia experienced, 113 patients (22%) described severe hypoglycemia and 211 (41%) reported nocturnal hypoglycemia. A total of 144 patients (28%) reported more than four hypoglycemic events in the previous month. There were no differences among the percentages of patients reporting hypoglycemia when analyzed by groups divided according to duration of use of insulin analogues  or type The median DTSQs score in the overall sample was 32 (IQR 29\u201335) . The medThe satisfaction score with the experience with current treatments  was obtained with a specific question with scores ranging from 0 to 10. The score obtained  was higher than the score obtained for previous treatments (NPH and/or regular human insulin), which was 5 , reflecting increased satisfaction over time (p < 0.001). Patients without prior use of NPH or regular human insulin were not included in these analyses.Most patients  had a positive screening  for common mental disorders . The ratStrict glucose control in type 1 diabetes mellitus reduces the risk of chronic disease complications at the expense of an increased number of hypoglycemic events ,18. The Hypoglycemia is one of the main problems in patients with type 1 diabetes mellitus. These patients have an indeterminable number of episodes of asymptomatic hypoglycemia and an average of two events of symptomatic hypoglycemia per week . In the An interesting finding of our study was that the rate of hypoglycemia remained unchanged over time in patients who already used insulin analogues. In contrast, data from the literature indicate that the risk of hypoglycemia increases markedly with the duration of the disease .As a group with prior risk of severe hypoglycemia, our study patients who received insulin analogues via administrative proceedings abided to the requirement of the dispensing protocol, in which the presence of at least two events of severe hypoglycemia within 6 months was one of the criteria. These patients receive insulin free of charge from the state, but bear the expense of the needles that are necessary for insulin injection, thereby promoting, in many cases, excessive needle reuse .Similar to previously described in other self-report studies, the patients in the present study identified the episodes of hypoglycemia by the occurrence of symptoms, blood glucose testing alone, or a combination of both ,22. ThisAnother important finding of our study was that the patients were considerably more satisfied with the current diabetes treatment with insulin analogues compared with prior treatment with NPH and regular human insulin, as evaluated using a specific question with scores ranging from 0 to 10. This may be an important result since, according to the literature, treatment satisfaction is associated with better glucose control . PreviouIn our evaluation of the DTSQs per individual item, satisfaction was high in the six subscales of the questionnaire. Factors such as the similarity of insulin analogues to endogenous insulin with regard to pharmacokinetics, regimen complexity reduction, and dose frequency may have contributed to greater treatment satisfaction among our patients ,29. The Our study found a high rate of patients screening positive for common mental disorders (77%) compared with a previous study in 358 patients with diabetes, in which 29% screened positive for common mental disorders . HoweverOn analysis stratified by duration of use of insulin analogues, patients using insulin analogues for less than 1 year were older than those using insulin analogues for more than 5 years. This finding of patients newly enrolled in the protocol for the acquirement of insulin analogues being older at diagnosis may be related to a more stringent technical criteria for access to insulin analogues implemented after updates in the SES-RS dispensing protocol.e.g., HbA1c), which were not available in the SES-RS computerized drug delivery system. Also, we did not evaluate if hypoglycemia unawareness could have influenced our results. However, the characteristics of our study enabled the inclusion of more patients, driving significant observations in regard to the real-life impact of patient satisfaction with treatment. The sample represented more than 50% of most regional health coordinating units, and due to factors including temporary shortages of insulin analogues and difficulty of applying the questionnaire in some cities, did not include the entire planned sample but was overall representative of the population.Limitations of the present study include the fact that patients who are dissatisfied with the therapy or with the paperwork involved for acquiring insulin analogues in Brazil have the option to switch back to human insulin, which is also offered free of charge. Other limitations include the observational and retrospective design of the study, and the use of self-report data (which may not have reflected accurately the current blood glucose level of the participants in cases of hypoglycemia), and the absence of measurements of glycemic control (In conclusion, despite high rates of hypoglycemia and positive screening for common mental disorders, patients with type 1 diabetes mellitus using insulin analogues maintained great satisfaction with their diabetes treatment, which remained unchanged in the long term, unlike reports from other interventions in chronic diseases. Due to our study design, we were unable to confirm that the hypoglycemia rates were higher with treatment received prior to insulin analogues, as hypothesized. Observational studies, such as the present one, are essential since they are conducted in a real-world environment and provide valuable data regarding the use of a drug in clinical practice without the strict supervision of a randomized controlled trial. Additional studies and analyses are needed to investigate in each health macroregion of the state a potential association between hypoglycemia and conventional predictive factors of hypoglycemia including ethnic, cultural, and health-related factors.", "texts": ["The aim of this study was to evaluate the frequency of hypoglycemia and the treatment satisfaction in patients with type 1 diabetes (T1D) using insulin analogues.This observational retrospective study included 516 adult patients with T1D from 38 cities in Southern Brazil. Demographics and clinical data were collected using a self-report questionnaire. Hypoglycemia was defined as an event based on either symptoms or self-monitored blood glucose < 70 mg/dL. Treatment satisfaction was evaluated using the Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) and with a specific question with scores ranging from 0\u201310. Common mental disorders were assessed using the General Health Questionnaire (GHQ-12).Overall, the mean age was 38 \u00b1 14 years and 52% of the participants were women. The median diabetes duration was 18 years. The scores for insulin analogue treatment satisfaction were higher than those for previous treatments. DTSQ scores had a median value of 32 (interquartile range 29\u201335) and remained unchanged over time. The percentage of patients with hypoglycemia  was comparable across groups divided according to duration of use of insulin analogues. Most patients  screened positive for common mental disorders.Patient satisfaction with insulin analogue treatment was high and remained unchanged with time. Episodes of hypoglycemia also remained unchanged over time among patients using insulin analogues. Type 1 diabetes mellitus is a chronic and progressive disease with an increasing incidence over the past decades. Estimates project that 5\u201310% of all 12 million patients with diabetes in Brazil have type 1 diabetes .The Diabetes Control and Complications Trial (DCCT) has shown that strict glycemic control in patients with diabetes significantly decreases the risk of chronic complications . After tBecause of their pharmacological profile, insulin analogues can better mimic endogenous insulin production compared with human insulin, thus contributing to a decreased frequency of hypoglycemia and improved treatment satisfaction . Some stAnother limitation in interpreting the results of studies that have associated the use of insulin analogues with better patient satisfaction with treatment is that other parameters such as depression and anxiety can also impact patient satisfaction . Indeed,In addition to the concerns regarding the potential advantages of therapy with insulin analogues, it is unclear whether patient satisfaction with this specific therapy could reduce over time, as observed with other interventions in chronic diseases . We hypoHospital de Cl\u00ednicas de Porto Alegre (Certificado de Apresenta\u00e7\u00e3o para Aprecia\u00e7\u00e3o \u00c9tica \u2013CAAE-1.283.728).This was an observational study carried out from April 2016 to December 2017. The protocol of the study was approved by the research ethics committee of The primary outcomes were the frequency of hypoglycemia and treatment satisfaction of patients with type 1 diabetes mellitus after starting treatment with insulin analogues provided by the government, seeking possible predictors of greater satisfaction and fewer hypoglycemic events. A secondary outcome was the impact of the duration of treatment with insulin analogues on the primary outcomes.The public health system in the state of Rio Grande do Sul is geographically divided into 19 regional health coordinating units. These 19 units comprehend different numbers of municipalities, totaling 498 in the entire state. To determine the locations for data collection, we first selected 19 municipalities to represent each coordinating unit. Other 21 municipalities were randomly selected to complete the number of patients necessary to represent the regional health coordination units that received insulin analogues in the state.Patients were invited to participate in the study upon their arrival at the pharmacy to pick up short- or long-acting insulin analogues dispensed by administrative or judicial procedures. A written informed consent was signed by the patients included in the study or their legal guardians.The eligible population comprised patients aged 18 years or more, with type 1 diabetes mellitus treated with short-acting  and/or long-acting  insulin analogues supplied by the Health Secretariat of Rio Grande do Sul (SES-RS) via an administrative or judicial procedure. Patients with impaired cognition or communication barriers were excluded.i.e., type 1 diabetes mellitus, use of human insulin for at least 6 months, HbA1c level < 12%, at least two severe hypoglycemic events over 6 months, and follow-up with an endocrinologist for at least 6 months. Patients who did not meet all the criteria to receive insulin analogue via an administrative procedure appealed to the judiciary to receive the medication via a judicial procedure.To receive insulin analogues via an administrative procedure, a patient is required to have certain inclusion criteria, Clinical and sociodemographic characteristics were obtained using a self-report questionnaire. For the hypoglycemic outcomes, the questionnaire referred to the month before study enrollment. Hypoglycemia was defined as an event based on either symptoms or self-monitored blood glucose < 70 mg/dL. Severe hypoglycemia was defined according to the American Diabetes Association as any hypoglycemic event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions . Nocturni.e., 0 represents \u201cnever\u201d, and 6 represents \u201cmost of the time\u201d. Scores for all DTSQs items except for items two and three were used for the total DTSQs score, which ranged from 0 to 36. Higher scores indicated greater treatment satisfaction.Treatment satisfaction was analyzed using the Portuguese version of the Diabetes Treatment Satisfaction Questionnaire status version (DTSQs), an 8-item inventory assessing therapy for type 1 diabetes mellitus in the previous weeks. This survey measures general satisfaction, adequacy, flexibility, diabetes understanding, and willingness to recommend the current treatment to other people and maintain such treatment . Each itFor mental health screening, the participants filled out the 12-item General Health Questionnaire (GHQ-12) translated into Brazilian Portuguese and validated for the Brazilian population . This seExperience with the current and previous treatments was also evaluated using a specific question with scores ranging from 0 to 10, obtained through a self-report questionnaire. Other relevant survey information, including the patients\u2019 weight (kg), height (cm), and insulin dispensing process , were collected from the SES-RS computerized drug delivery system by a trained and authorized researcher.Considering an alpha error of 5% and a confidence interval range of 8%, the sample size calculation yielded 527 individuals.Data were described using measures of central tendency  and dispersion (standard deviations and interquartile range [IQR]) for continuous variables and absolute numbers and proportions for categorical variables. Analysis of variance (ANOVA) was used for comparing numerical variables with normal distribution, and the Kruskal-Wallis test for data without normal distribution. The Mann-Whitney and Wilcoxon tests were used for paired samples, and the chi-square test was used to compare categorical variables. P values < 0.05 were considered statistically significant. All analyses were performed using the statistical software SPSS v.16.0 .From 4124 patients with type 1 diabetes mellitus older than 18 years receiving insulin analogues from SES-RS, we selected 566 potential participants. Of these, 50 were excluded for not meeting the inclusion criteria, yielding a final sample of 516 patients. The patients in the final sample belonged to 38 of the 40 municipalities included in the sample selection. The collection of data from some municipalities was difficult and we were unable to achieve 100% representation for each coordinating unit.2  was 25 \u00b1 5 kg/m2 . The med2 . RegardiAmong all patients included in the study, 350 (74%) reported hypoglycemia the month before data collection. Regarding the type of hypoglycemia experienced, 113 patients (22%) described severe hypoglycemia and 211 (41%) reported nocturnal hypoglycemia. A total of 144 patients (28%) reported more than four hypoglycemic events in the previous month. There were no differences among the percentages of patients reporting hypoglycemia when analyzed by groups divided according to duration of use of insulin analogues  or type The median DTSQs score in the overall sample was 32 (IQR 29\u201335) . The medThe satisfaction score with the experience with current treatments  was obtained with a specific question with scores ranging from 0 to 10. The score obtained  was higher than the score obtained for previous treatments (NPH and/or regular human insulin), which was 5 , reflecting increased satisfaction over time (p < 0.001). Patients without prior use of NPH or regular human insulin were not included in these analyses.Most patients  had a positive screening  for common mental disorders . The ratStrict glucose control in type 1 diabetes mellitus reduces the risk of chronic disease complications at the expense of an increased number of hypoglycemic events ,18. The Hypoglycemia is one of the main problems in patients with type 1 diabetes mellitus. These patients have an indeterminable number of episodes of asymptomatic hypoglycemia and an average of two events of symptomatic hypoglycemia per week . In the An interesting finding of our study was that the rate of hypoglycemia remained unchanged over time in patients who already used insulin analogues. In contrast, data from the literature indicate that the risk of hypoglycemia increases markedly with the duration of the disease .As a group with prior risk of severe hypoglycemia, our study patients who received insulin analogues via administrative proceedings abided to the requirement of the dispensing protocol, in which the presence of at least two events of severe hypoglycemia within 6 months was one of the criteria. These patients receive insulin free of charge from the state, but bear the expense of the needles that are necessary for insulin injection, thereby promoting, in many cases, excessive needle reuse .Similar to previously described in other self-report studies, the patients in the present study identified the episodes of hypoglycemia by the occurrence of symptoms, blood glucose testing alone, or a combination of both ,22. ThisAnother important finding of our study was that the patients were considerably more satisfied with the current diabetes treatment with insulin analogues compared with prior treatment with NPH and regular human insulin, as evaluated using a specific question with scores ranging from 0 to 10. This may be an important result since, according to the literature, treatment satisfaction is associated with better glucose control . PreviouIn our evaluation of the DTSQs per individual item, satisfaction was high in the six subscales of the questionnaire. Factors such as the similarity of insulin analogues to endogenous insulin with regard to pharmacokinetics, regimen complexity reduction, and dose frequency may have contributed to greater treatment satisfaction among our patients ,29. The Our study found a high rate of patients screening positive for common mental disorders (77%) compared with a previous study in 358 patients with diabetes, in which 29% screened positive for common mental disorders . HoweverOn analysis stratified by duration of use of insulin analogues, patients using insulin analogues for less than 1 year were older than those using insulin analogues for more than 5 years. This finding of patients newly enrolled in the protocol for the acquirement of insulin analogues being older at diagnosis may be related to a more stringent technical criteria for access to insulin analogues implemented after updates in the SES-RS dispensing protocol.e.g., HbA1c), which were not available in the SES-RS computerized drug delivery system. Also, we did not evaluate if hypoglycemia unawareness could have influenced our results. However, the characteristics of our study enabled the inclusion of more patients, driving significant observations in regard to the real-life impact of patient satisfaction with treatment. The sample represented more than 50% of most regional health coordinating units, and due to factors including temporary shortages of insulin analogues and difficulty of applying the questionnaire in some cities, did not include the entire planned sample but was overall representative of the population.Limitations of the present study include the fact that patients who are dissatisfied with the therapy or with the paperwork involved for acquiring insulin analogues in Brazil have the option to switch back to human insulin, which is also offered free of charge. Other limitations include the observational and retrospective design of the study, and the use of self-report data (which may not have reflected accurately the current blood glucose level of the participants in cases of hypoglycemia), and the absence of measurements of glycemic control (In conclusion, despite high rates of hypoglycemia and positive screening for common mental disorders, patients with type 1 diabetes mellitus using insulin analogues maintained great satisfaction with their diabetes treatment, which remained unchanged in the long term, unlike reports from other interventions in chronic diseases. Due to our study design, we were unable to confirm that the hypoglycemia rates were higher with treatment received prior to insulin analogues, as hypothesized. Observational studies, such as the present one, are essential since they are conducted in a real-world environment and provide valuable data regarding the use of a drug in clinical practice without the strict supervision of a randomized controlled trial. Additional studies and analyses are needed to investigate in each health macroregion of the state a potential association between hypoglycemia and conventional predictive factors of hypoglycemia including ethnic, cultural, and health-related factors."]}
{"representative": "The aim of this paper is to investigate the effects of information technology (IT) capability on firm growth in the context of open technological innovation. The paper utilized a logical deductive approach to develop hypotheses and analytical frameworks, and collected empirical data from 256 Chinese new ventures. Regression analysis and structural equation models were used to test the hypotheses and analyze the data. The results showed that IT capability, including flexibility and integration of information technology, significantly influenced firm growth, and open technological innovation partially mediated the relationship between IT flexibility and firm growth, and significantly mediated the relationship between IT integration and firm growth. The paper\u2019s limitations include the cross-sectional design, limited sample size, and potential unobserved variables such as organizational learning that could affect the relationship between IT capability and firm growth. The research is the first to investigate the effects of IT capability on firm growth based on the mediation of open technological innovation in China, contributing to the literature on IT capability and providing insights for managerial practice in the sharing economy era. In 2021, China adopted and implemented the \u201c14th Five-Year Plan\u201d to guide its economic development and the growth of firms over the next five years. This plan identifies \u201cinformation technology,\u201d \u201cinnovation,\u201d and \u201centrepreneurship\u201d as key drivers of economic growth, and places a strong emphasis on encouraging business innovation and supporting the formation and growth of new firms. Encouraging self-employment has emerged as a primary strategy to address the talent employment problem and promote stable economic growth and market economic vitality. In this context, new ventures play a crucial role in providing employment opportunities and promoting technological innovation, as well as contributing to social and economic development Reviewers' comments:Reviewer's Responses to Questions <font color=\"black\"> Comments to the Author1. Is the manuscript technically sound, and do the data support the conclusions? </font> The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1:\u00a0PartlyReviewer #2:\u00a0YesReviewer #3:\u00a0Partly********** <font color=\"black\"> 2. Has the statistical analysis been performed appropriately and rigorously?  </font> Reviewer #1:\u00a0NoReviewer #2:\u00a0YesReviewer #3:\u00a0No********** <font color=\"black\"> 3. Have the authors made all data underlying the findings in their manuscript fully available?PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data\u2014e.g. participant privacy or use of data from a third party\u2014those must be specified. </font> The Reviewer #1:\u00a0YesReviewer #2:\u00a0YesReviewer #3:\u00a0Yes********** <font color=\"black\"> 4. Is the manuscript presented in an intelligible fashion and written in standard English? </font> PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.Reviewer #1:\u00a0YesReviewer #2:\u00a0YesReviewer #3:\u00a0Yes********** <font color=\"black\"> 5. Review Comments to the Author </font> Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. Reviewer #1:\u00a0The authors' contribution is valuable and much appreciated, however, the manuscript needs some improvements as suggested below:1. Research Hypotheses: Logically there should be one more hypothesis for Open Technological Innovation and Firm Growth. In order to assess the mediation of Open Tech Innovation between the independent and dependent variables, the direct relationship between the mediator and the dependent variable must be examined first, and it should be statistically significant before assessing the indirect effect. Thus, it is mandatory to have an hypothesis to test the direct effect of mediator on dependent variable.2. Validity and Reliability: Though authors provided content validity and reliability statistics, it is desired to provide convergent and discriminant validity statistics as they are core components are scale validity in Structural Equation Modeling.3. The provided datafile seems corrupt showing random symbols instead of the data.Reviewer #2:\u00a0PLOS ONEInformation Technology Capability, Open Technological Innovation and Firm GrowthManuscript Number: PONE-D-22-14268Introduction and literature reviewIndeed, the introduction to this article is very well written, but I have a few recommendations for you that must be implemented.i.The introduction section must offer the study gap and objectives of the study.ii.Highlight current work contributions.iii.The selection of variables for the current study must be elaborated briefly.iv.Recent evidence should be presented to support the study's hypotheses.v.\u201cOn the other hand, novelty is essential for overcoming resource constraints and establishing a competitive advantage \u201d Pay attention to citations; it is not necessary to bring up unrelated facts.vi.Relevant references, including introduction, literature review, and hypothesis development, must be from within the last five years, except for theories and books.Conceptual modeli.I would recommend that you create a table before the research framework and mention previous studies from the last five years, including methodology, variables, and countries, and then draw your research gap.Methodologyi.In the field of social studies, is a sample size of 28.7 percent acceptable? strengthen your argument with references to pertinent sources.ii.Sample size calculation must be performed and reported with the use of Gpower 3.1 software.Variables and measuresCreate a table for variables and mentions, variable names, number of items, and previous authors.Variables No. of itemsAuthor's (previous authors)Discussion and Conclusioni.Compare the results of your study with previous studies in the discussion and conclusion section.ii.Contributions and limitation & future research should be inline.Reviewer #3:\u00a0The above points are fundamental and need to be addressed very carefully. I would strongly encourage the author(s) to take ample time to rethink their study, read more papers from good and reputed journals and try to completely re-write their study.********** <font color=\"black\"> 6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.If you choose \u201cno\u201d, your identity will remain anonymous but your review may still be made public.Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. </font> Reviewer #1:\u00a0NoReviewer #2:\u00a0NoReviewer #3:\u00a0No**********https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at\u00a0figures@plos.org. Please note that Supporting Information files do not need this step.While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool,\u00a0AttachmentPONE-D-22-14268_reviewer.docxSubmitted filename: Click here for additional data file.AttachmentReferee Report Plos One.docxSubmitted filename: Click here for additional data file. 22 Mar 2023Response to ReviewersDear Editor and Reviewers:Thank you for your letter and the reviewers\u2019 comments on our manuscript titled \u201cInformation Technology Capability, Open Technological Innovation and Firm Growth\u201d (ID: PONE-D-22-14268). We appreciate the valuable and constructive comments, which have guided us to improve and refine our paper. We have meticulously reviewed the suggestions and incorporated the necessary changes, which are highlighted in blue throughout the revised paper. The major revisions made in the manuscript in response to the reviewers\u2019 comments are outlined below:Responds to the reviewers\u2019 comments:Reviewer: 1The authors\u2019 contribution is valuable and much appreciated, however, the manuscript needs some improvements as suggested below:Comments:1. Research Hypotheses: Logically there should be one more hypothesis for Open Technological Innovation and Firm Growth. In order to assess the mediation of Open Tech Innovation between the independent and dependent variables, the direct relationship between the mediator and the dependent variable must be examined first, and it should be statistically significant before assessing the indirect effect. Thus, it is mandatory to have an hypothesis to test the direct effect of mediator on dependent variable.Reply: We appreciate your suggestion. In this paper, we have adopted the Baron & Kenny (1986) method and utilized the stepwise test regression coefficient to examine the mediating effect. The first step involves testing the overall impact of the independent variable on the dependent variable, followed by assessing the connection between the independent variable and the mediator variable in the second step. Finally, the third step involves evaluating the influence of both the independent and mediator variables on the dependent variable. Consequently, this paper does not examine the link between the mediator variable  and the dependent variable .2. Validity and Reliability: Though authors provided content validity and reliability statistics, it is desired to provide convergent and discriminant validity statistics as they are core components are scale validity in Structural Equation Modeling.Reply: As suggested by the reviewer, we have added the convergent and discriminant validity statistics to support reliability and validity test.(Please see the blue font on page 11 in Section 4.1)\u201c4.1 Reliability and validityTo ensure the proposed model\u2019s quality, it must be both statistically reliable and valid. Reliability means producing similar results across multiple tests under the same conditions. Cronbach\u2019s alpha is a widely used measure of reliability, and in this study, three measures were examined. The obtained values of 0.826, 0.784, and 0.780, respectively, all higher than 0.75, indicating high reliability of the proposed model.The validity of an analysis refers to the degree to which it accurately represents the intended information. Validity can be analyzed through content and construct validity analysis methods. Content validity evaluates the extent to which the questionnaire items accurately reflect the intended content. In this study, the questionnaire items were primarily drawn from the maturity scale, which had been reviewed and revised by the research team\u2019s professor. During the pilot test, no reports of misunderstandings were received, and interviewees indicated that the items were easy to understand, indicating satisfactory content validity. .The confirmatory factor analysis (CFA) is a powerful method used to assess construct validity. According to Campbell and Fiske\u2019s seminal work (1959), construct validity research typically examines the degree to which data provide, including convergent validity and discriminant validity.Table II presents the results of the CFA for assessing convergent validity. All factor loadings were significant and exceeded the recommended threshold of 0.5 , indicating strong convergent validity. To assess the model fit, several well-established goodness-of-fit indices were utilized, including the normed chi-square (\u03c72/df), the goodness-of-fit index (GFI), the adjusted goodness-of-fit index (AGFI), and the root mean square error of approximation (RMSEA) . In the measurement model, all indices exceeded their recommended thresholds, indicating sufficient construct validity.Discriminant validity is demonstrated when the square root of the average variance extracted (AVE) for a construct is greater than the corresponding inter-construct correlations. As Table III indicates, the square root of the AVE for each variable exceeded the intercorrelations, indicating sufficient discriminant validity.Table II. Convergent validity of the measurement modelVariable AVE CRIT flexibility (ITF) 0.560 0.835IT integration (ITI) 0.532 0.771Open technological innovation (OTI) 0.557 0.789 &#x0f063; 2/df=2.768 (\uff1c3); GFI\uff1e0.9; AGFI\uff1e0.9; RMSEA\uff1c0.05Notes: AVE is the average variance extracted; CR is the critical ratio; goodness-of-fit indices and recommended thresholds \ufffdTable III. Discriminant validity of the measurement modelVariable ITF ITI OTIIT flexibility (ITF) 0.749 IT integration (ITI) 0.528 0.729 Open technological innovation (OTI) 0.446 0.416 0.746Note: The square root of the AVE as a criteria\u201d3. The provided datafile seems corrupt showing random symbols instead of the data.Reply: Thanks for your careful checks. We are sorry for our carelessness. Based on your comments, we have re-uploaded the data.\u2003Reviewer: 2Comments:1. Introduction and literature reviewIndeed, the introduction to this article is very well written, but I have a few recommendations for you that must be implemented.i. The introduction section must offer the study gap and objectives of the study.Reply: We feel great thanks for your professional review work on our article. As you suggest, we strengthen the description of study gap and objectives of the study.\u201cPrevious research has largely focused on the impact of resource constraints on the growth of new ventures, which is a crucial concern . However, while resource constraints are undoubtedly a significant challenge for new ventures, there may be other factors that affect the performance and growth of firms that have not been fully explored. One of these factors could be the relationship between IT capability and performance.There have been several studies investigating the link between IT capability and firm performance, but the results have been inconclusive. Some studies have shown a positive relationship between IT capability and firm performance , while others have reported a no relationship . These mixed results suggest that there may be some missing links in the relationship between IT capability and firm performance that have not been fully explored.Therefore, this study aims to examine the influence of open technological innovation, which is one of the potential mediators, in the relationship between IT capability and firm growth. Open technological innovation refers to the use of external knowledge and resources to develop new products, services, and processes. The study will investigate whether open technological innovation can serve as a mediator between IT capability and firm growth, filling the gap in the existing literature.\u201d(Please see the blue font on page 3 in Section 1)ii. Highlight current work contributions.Reply: Thanks for your insight! As your suggestion, we have explicitly outlined the contributions of our current work.\u201cThis study contributes to the literature in three ways. Firstly, it explores the relationship between IT capability and firm growth, expanding the current research on firm growth that has primarily focused on IT investments. Secondly, the study proposes a conceptual model that considers the mediating variable of open technological innovation in this relationship. Lastly, this research is significant because while previous innovation management research has primarily focused on advanced economies, it provides insight into China, which has yet to be extensively explored.\u201d(Please see the blue font on page 4 in Section 1)iii. The selection of variables for the current study must be elaborated briefly.Reply: As your suggestion, we would like to clarify that the selection of variables has been elaborated in Section 2, i.e., \u201cLiterature Review and Hypotheses Development\u201d, which is further illustrated in Figure 1, i.e., \u201cTheoretical Framework and Conceptual Model\u201d.(Please see page 4-8 in Section 2)At the same time, a detailed discussion on variable measurement has been presented in Section 3.2, i.e., \u201cVariables and Measures\u201d.(Please see page 9-10 in Section 3.2)iv. Recent evidence should be presented to support the study\u2019s hypotheses.Reply: Thank you for your feedback regarding our study. We appreciate your suggestion to present recent evidence to support our study\u2019s hypotheses.In response to your comment, we have conducted a thorough review of recent literature in the field and have updated our study to include the most relevant and up-to-date evidence available. We have taken great care to ensure that our hypotheses are well-supported by the latest research in the field.We believe that this revision has significantly strengthened the theoretical foundation of our study, and we are confident that our hypotheses are now well-supported by the latest available evidence. We hope that this updated version of our study meets your expectations and addresses your concerns.(Please see \u201cLiterature review and hypotheses development\u201d on page 4-8 in Section 2)v. \u201cOn the other hand, novelty is essential for overcoming resource constraints and establishing a competitive advantage \u201d Pay attention to citations; it is not necessary to bring up unrelated facts.Reply: Thanks for your suggestion. As your recommendation, we have removed the mentioned sentence.(Please see page 3 in Section 1)vi. Relevant references, including introduction, literature review, and hypothesis development, must be from within the last five years, except for theories and books.Reply: Thanks for your suggestion! In response to your comment, we have conducted a thorough review of our references and have updated our study to include more recent and relevant references where appropriate. We have taken great care to ensure that our references meet your standards for academic rigor and quality.2. Conceptual modeli. I would recommend that you create a table before the research framework and mention previous studies from the last five years, including methodology, variables, and countries, and then draw your research gap.Reply: Thank you for your suggestion. The idea of creating a table before the research framework is very good. While including previous studies is important for contextualizing research, the format and organization of the literature review can vary depending on the research question and methodology being used.Furthermore, the suggestion to create a table before the research framework may not be the most effective way for us to organize the literature review in this paper, as it may not allow for a comprehensive discussion of the research gap and how the current study addresses it. As such, I will be structuring the literature review in a manner that aligns with the specific goals and objectives of the research project. Thank you again for your suggestion.(Please see page 4-8 in Section 2)3. Methodologyi. In the field of social studies, is a sample size of 28.7 percent acceptable? strengthen your argument with references to pertinent sources.Reply: Thanks for your insight! The percentage of valid data was calculated to be 28.7% based on the distribution of a full sample questionnaire. However, it should be noted that the recovered sample size was 4168, out of which only 2874 questionnaires were deemed valid, accounting for 68.95%. Upon analyzing this data, we have made necessary modifications to the article.(Please see the blue font on page 8 in Section 3.1)ii. Sample size calculation must be performed and reported with the use of Gpower 3.1 software.Reply: Thanks for your suggestion! In Section 3.1, we have provided a report on the sample data. Moreover, a detailed descriptive statistical analysis of the data has been carried out and the findings have been presented in Table 1.(Please see the blue font on page 8 in Section 3.1)4. Variables and measuresi. Create a table for variables and mentions, variable names, number of items, and previous authors.Variables No. of items Author's (previous authors)Reply: Thank you for your helpful suggestion. We appreciate your input on this matter. While we agree that creating a table for the variables and elements, variable names, number of items, and previous authors would be useful, we regret to inform you that we are unable to do so due to space limitations. However, we have provided detailed information on the names, measurement methods, and reference sources of each variable in the main text, which we believe will adequately address the yours concerns. We hope that you will find our approach acceptable(Please see the blue font on page 9-10 in Section 3.2)5. Discussion and Conclusioni. Compare the results of your study with previous studies in the discussion and conclusion section.Reply: Thank you for your helpful suggestion. We acknowledge the importance of situating our findings in the context of previous research in the discussion and conclusion section. In the revised manuscript, we will provide a comprehensive review of the relevant literature and compare our results with those of previous studies. We will highlight the similarities and differences between our findings and those of previous research, and discuss the implications of our results for theory and practice. We believe that this will enhance the contribution of our study to the literature on innovation management and provide a more nuanced understanding of the relationship between IT capability, open technological innovation, and firm growth. We appreciate your input and look forward to incorporating your feedback into the revised manuscript.\u201cThis study contributes to the existing literature on the relationship between IT capability and firm growth by examining the mediating effects of open technological innovation. Our findings are consistent with previous research that suggests IT capability positively influences firm growth . However, our study provides a more nuanced understanding of this relationship by showing that open technological innovation plays a partial mediating role in this relationship. Specifically, our results suggest that new ventures that are able to leverage open technological innovation can better translate their IT capabilities, such as IT flexibility and IT integrality, into firm growth.This study also extends the literature on open innovation by highlighting its importance in the context of new ventures. Our findings suggest that open technological innovation can be a valuable mechanism for new ventures to access external knowledge, resources, and networks, which can help them overcome resource constraints and compete with established firms . Furthermore, our study shows that open technological innovation can help new ventures to translate their IT capabilities into firm growth. This highlights the importance of managing innovation holistically and considering the interactions between different types of innovation.\u201d(Please see the blue font on page 15 in Section 5.1)ii. Contributions and limitation & future research should be inline.Reply: We appreciate the reviewer\u2019s valuable feedback on our paper. We have made several modifications to the paper. Specifically, we have revised the conclusion section to more clearly highlight our contributions and limitations, and to provide a more focused and coherent discussion of the future research directions.In the revised conclusion section, we first summarize our key findings and contributions, including the relationship between IT capability, open technological innovation, and firm growth, and the important role of managing innovation holistically. We then highlight the limitations of our study, including the cross-sectional design and potential sampling bias. Finally, we provide a clear and focused discussion of the future research directions, including the need for longitudinal studies, industry-specific studies, and studies that examine the role of other mediators in the relationship between IT capability and firm growth.Overall, we believe that these modifications have help to more clearly and coherently present the contributions, limitations, and future research directions of our study.(Please see the blue font on page 15-17 in Section 5)\u2003Reviewer: 3This study investigates the influence of open technological innovation, one of the potential mediators, in the link between IT capability and firm growth in China by using cross-sectional data of 259 ventures. The study finds that IT capability, including flexibility and integration of information technology, has a significant factor in firm advancement. Also, results confirm that open technological innovation plays a significant mediating role between IT integration and firm growth. The study recommended that IT integration needs the Internet-information-system can be flawlessly combined with the system of innovation partners, and can easily access, exchange and aggregate the resources and data of innovation partners, so as to integrate and absorb.Although the paper does follow a regular type of analysis for paper implementing theoretical/empirical mechanisms studies, I was not really impressed by the total picture of it. After all, the author(s) themselves recognize that their novelty comes from the fact that the theoretical mechanisms have not dealt with this country sample. I am afraid though that the paper in its current form is way too underdeveloped both theoretically and empirically. It seems that the author(s)would greatly benefit by submitting their work to some conferences to get feedback and to their colleagues for some reviews. There could be merit in what you are trying to explain, to my understanding open technological innovation and how/when it affects positively or not on firm growth and capability. Even then, the paper suffers from a number of weaknesses that must be explicitly considered in improving the picture of it. In particular:Comments:1. The introduction includes one and half page that do not communicate well with each other. The introduction is mostly focused on general background, while it should be specific with target firms and country. The work is not well written and shows flaws in the structuring of logical arguments without highlighting the original pizzle. Authors need to make clearer what we have learned from previous studies and what we are uncertain about. There are many more! this research needs to build on these and demonstrates very clearly how you build on and extend this stream of research. The second research question is also not new. For example, the study indicated that using IT capacity instead of IT investment capacity is significant contribution however this couldn\u2019t unique contribution. Because investment and capacity can be used robust analysis to allow you to make better decisions. Also, there are studies who investigate the relationship between IT capacity and firm performance, e.g., Liu et al. . It is widely accepted that the relationship between IT innovation and firm growth and there are numerous studies on this. In what ways do your conceptualizations advance this literature? Also, the target country is China, how this study could impact globally. Authors should explain what the importance of this study is. I mean the paper should incorporate clearer motivation and background of the issue and its importance.Reply: Thank you for your comment. We understand the importance of providing a clear motivation and background of the issue in our paper.Our study aims to examine the influence of open technological innovation as a mediator between IT capability and firm growth for new ventures in China. Given China\u2019s emphasis on promoting innovation and entrepreneurship in its 14th Five-Year Plan, and the increasing importance of IT capability and open technological innovation in the digital economy, our study has important implications for new venture development and economic growth in China and globally.Moreover, our study contributes to the existing literature by expanding current research on firm growth, proposing a conceptual model that considers the mediating variable of open technological innovation, and providing unique insights into the challenges and opportunities facing new ventures in China.Therefore, we will ensure that our paper clearly communicates the motivation and background of the issue, and the significance of our study for new venture development, economic growth, and innovation management in China and beyond.\u201c1. IntroductionIn 2021, China adopted and implemented the \u201c14th Five-Year Plan\u201d to guide its economic development and the growth of firms over the next five years. This plan identifies \u201cinformation technology,\u201d \u201cinnovation,\u201d and \u201centrepreneurship\u201d as key drivers of economic growth, and places a strong emphasis on encouraging business innovation and supporting the formation and growth of new firms. Encouraging self-employment has emerged as a primary strategy to address the talent employment problem and promote stable economic growth and market economic vitality. In this context, new ventures play a crucial role in providing employment opportunities and promoting technological innovation, as well as contributing to social and economic development .Despite their potential, new ventures often face challenges in acquiring external resources due to their \u201cnewness,\u201d lack of full performance records, and information asymmetry, which can exacerbate resource constraints and create uncertainty in their growth trajectory . Academic research has explored various theories and strategies to address these challenges, including resource integration and patching . However, new ventures still struggle to meet their growth demands with internal resources alone, often requiring deep relationships with external organizations and resource repurposing to drive innovation . Additionally, new ventures must prioritize innovation to break existing corporate monopolies and adapt to rapidly changing external circumstances, thereby minimizing the risks associated with their relative lack of experience and expertise .In the current era characterized by the Internet and the digital economy, technology innovation is accelerating, and demand is rapidly evolving. The complexity, systematicity, timeliness, and high investment required for innovation have made a significant impact on innovation agents. However, with the advancement of Internet technology and the transformation of corporate innovation concepts, new ventures can aggregate innovation resources worldwide by building information technology capabilities. This approach breaks the limits of traditional ownership and achieves low cost and high efficiency in innovation at a fast pace. Open technological innovation involves organizations that go beyond their original organizational boundaries to tap into external sources of innovation knowledge. They can effectively integrate these resources through internal organizational processes, which enables them to turn them into technological innovation achievements that add value .Organizational innovation openness is considered a fundamental component for determining the success of enterprises in open technological innovation research. Meanwhile, the industrial environment is changing rapidly, and new ventures face new challenges as a result of the rapid growth of internet-based information technology . The economic environment has dramatically changed, and innovation efforts have become more complex, with a clear cross-domain tendency. Firms are struggling to meet the new requirements with their existing resources, and using external resources for open innovation has become a significant consideration for them . Several factors, such as perceived cost savings and income generation, external pressure, organizational preparedness, and perceived ease of use, have a significant impact on IT investments for new ventures . In new ventures, IT investments may vary from IT investment in big enterprises since a smaller number of people have decision-making responsibilities, standard procedures are not created, and long-term planning is restricted. Furthermore, there is a higher dependency on external IT professionals in new ventures . However, IT capability may help new ventures survive in the long run by providing access to external knowledge and financial resources, building trust and legitimacy through widespread information transmission, and improving social network links . New environmental conditions also enable new ventures to overcome resource constraints in the innovation process by improving their IT capability to achieve a long-term competitive advantage .Previous research has largely focused on the impact of resource constraints on the growth of new ventures, which is a crucial concern . However, while resource constraints are undoubtedly a significant challenge for new ventures, there may be other factors that affect the performance and growth of firms that have not been fully explored. One of these factors could be the relationship between IT capability and performance. There have been several studies investigating the link between IT capability and firm performance, but the results have been inconclusive. Some studies have shown a positive relationship between IT capability and firm performance , while others have reported a no relationship . These mixed results suggest that there may be some missing links in the relationship between IT capability and firm performance that have not been fully explored.Therefore, this study aims to examine the influence of open technological innovation, which is one of the potential mediators, in the relationship between IT capability and firm growth. Open technological innovation refers to the use of external knowledge and resources to develop new products, services, and processes. The study will investigate whether open technological innovation can serve as a mediator between IT capability and firm growth, filling the gap in the existing literature.This study contributes to the literature in three ways. Firstly, it explores the relationship between IT capability and firm growth, expanding the current research on firm growth that has primarily focused on IT investments. Secondly, the study proposes a conceptual model that considers the mediating variable of open technological innovation in this relationship. Lastly, this research is significant because while previous innovation management research has primarily focused on advanced economies, it provides insight into China, which has yet to be extensively explored.The structure of the paper is organized as follows. Section two provides a literature review and develops the hypotheses. Section three shows the data and methods employed in the empirical study. Section four presents the empirical results, and Section five concludes with some important contributions and limitations of the study and directions for future research.\u201d(Please see the blue font on page 3-4 in Section 1)2. There is no theoretical model or offers no innovation since it has been well established in the relevant literature. Your argumentation of the hypotheses is not sufficient. Your need to develop a theoretical framework and follow the same line to develop all the three arguments. At the moment, there is really nothing useful there. It is not convincing at all. Also, your hypotheses refer to Chinese firms - there is no generalization there. e.Reply: Thank you for your suggestion. We acknowledge that our current hypotheses are not sufficiently grounded in a theoretical framework, and we recognize the importance of developing a more comprehensive argumentation to support our research. We will take steps to address this by conducting further research and analysis to strengthen our theoretical framework and develop a more convincing case for our study.(Please see \u201cLiterature review and hypotheses development\u201d on page 4-8 in Section 2)Regarding the generalizability of our hypotheses to firms outside of China, we agree that it is important to consider the context of our study and the potential limitations in generalizing our findings to other settings. We will include a discussion in our paper about the potential applicability of our results to other regions or contexts, as well as the limitations of our study in this regard.(Please see \u201cLimitations and future research\u201d on page 17 in Section 5.4)3. It would be helpful if you could relate your hypotheses in a theoretical framework and follow this up with a clearly pronounced hypotheses that relates to the theoretical argument made prior. The operationalisation of the hypothesis is not part and parcel of why you argue this particular hypothesis and should be presented in the methods section. The selection and justifications of the variables should be further discussed with supporting references.Reply: Thanks for your insight! We appreciate your suggestion to relate our hypotheses to a theoretical framework and provide a clearer justification for our argument. We recognize the importance of a well-grounded theoretical argument and will work to develop a more comprehensive framework to support our hypotheses.We also agree with your suggestion to separate the operationalization of our hypotheses from the theoretical argument and to present this in the methods section. We will provide a clear and detailed explanation of the methods used to operationalize our hypotheses, as well as the selection and justification of the variables.(Please see \u201cVariables and measures\u201d on page 9-10 in Section 3.2)4. The study used the survey data of 256 new ventures out of 2854 valid surveys. However, there should discussion about the validity of the surveys. Also, why chosen provinces were Beijing, Tianjin, Shandong Jiangsu and Hebei?Reply: Thank you for your feedback. First, as your suggestion, we have added the analysis of reliability and validity.Second, with regards to the selection of provinces in the study, we chose Beijing, Tianjin, Shandong, Jiangsu, and Hebei because they are among the most economically developed and populous provinces in China, and have a high concentration of new ventures. These provinces also represent different regions and industries in China, which makes the findings more generalizable to other parts of the country. Additionally, we acknowledge that we have had access to data from these provinces, making it easier to conduct the research.5. In addition, the model could be used to identify the relationship between the variables with existing literature. For example, the section 3.2 should be linked with hypotheses and expected connection between the variables. Although, authors mentioned that they followed previous studies, Rai, 2010; Cui, 2015; Bi et al., 2017, for variables selection.Reply: Thanks for your insight! We appreciate your suggestion to link section 3.2 with hypotheses and expected connections between the variables. In the revised version of the paper, we will provide a more detailed explanation of how our study builds upon existing literature and link the variables with our hypotheses. We will also discuss how our findings compare with previous studies, to provide more context and strengthen the theoretical foundations of our research. We believe that these revisions will enhance the clarity and rigor of our paper and make it more useful for future research in this field.(Please see \u201cVariables and measures\u201d on page 9-10 in Section 3.2)6. The paper at its current version is a-theoretical. There is not a single theory you are basing your arguments or attempting to develop and inform through your research. Your paper could be drawing from International Business/finance theory (innovation) and learning from firm growth. It needs to draw on particular mechanisms and explain how/when/why growth in the domestic context is enhances when firms use IT capacity.Reply: Thanks for your insight! We agree that our paper can benefit from a stronger theoretical foundation. In the revised version of the paper, we will explicitly articulate the theoretical underpinnings of our study and demonstrate how they inform our research questions, hypotheses, and analysis.Specifically, our paper draws on several theoretical perspectives from the fields of international business, finance, and innovation to explore the relationship between IT capability, open technological innovation, and new venture growth in the Chinese context.From an international business perspective, our study is informed by the resource-based view (RBV) of the firm, which emphasizes the strategic importance of organizational resources and capabilities in creating and sustaining competitive advantage. In particular, our study focuses on the role of IT capability as a key resource that enables new ventures to leverage external knowledge and expertise, which can enhance innovation and improve growth performance.From a finance perspective, our study is informed by the capital structure theory, which suggests that firms with stronger IT capability are more likely to obtain external financing and thereby achieve greater growth potential.Lastly, from an innovation perspective, our study builds on the open innovation paradigm, which emphasizes the importance of external knowledge sources and collaboration in driving innovation and firm growth.We will further elaborate on these theoretical perspectives in the revised version of the paper and provide a more detailed explanation of how they inform our study. We will also explicitly outline the specific mechanisms through which IT capability can enhance new venture growth in the Chinese context, taking into account the unique institutional and cultural factors at play.(Please see \u201cIT capability and firm growth\u201d on page 4-6 in Section 2.1)7. Empirical findings supports the hypotheses however, there should be critical analysis and supported with existing literature. Therefore, the author is suggested to reconstruct the theoretical and empirical model to become more realistic.Reply: Thank you for your valuable feedback regarding our study. We appreciate your constructive criticism, and we will take your suggestions into consideration as we revise and improve our paper.In response to your comment, we revisit the literature review section of the paper to identify gaps and limitations in the existing literature, and to better support our theoretical and empirical models with relevant literature. We also provide a more detailed and critical analysis of our empirical findings, highlighting the strengths and limitations of our study\u2019s approach and analysis.Moreover, we carefully consider your suggestion to reconstruct our theoretical and empirical models to ensure that they are more realistic and aligned with existing literature. We revisit our research questions, hypotheses, and variables, and we will refine them based on your feedback to better represent the phenomena under investigation.8. Conclusion should not repetition of the results. Policy implications are not very clear.Reply: Thanks for your comments! Our revised conclusion and implications section now more clearly and concisely summarizes our key findings and provides actionable recommendations for future research and practical applications. We have made sure to avoid any repetition of our results, and instead, we have highlighted the implications of our findings in a more focused and relevant manner.We have also ensured that our policy implications are clear and actionable, and we have directly linked them to our research findings. Our revised implications section is now more closely aligned with our research objectives, and we believe that it provides a stronger and more meaningful conclusion to our study.(Please see \u201cConclusions and discussion\u201d on page 15-17 in Section 5)9. The above points are fundamental and need to be addressed very carefully. I would strongly encourage the author(s) to take ample time to rethink their study, read more papers from good and reputed journals and try to completely re-write their study. I wish you all the best of luck.Reply: Thank you for taking the time to review our paper and for sharing your thoughts with us. We appreciate your comments and are grateful for your insights.We understand the importance of carefully addressing all fundamental issues in our study and appreciate your feedback regarding the need to read more papers from good and reputed journals. We will take your advice to heart and spend ample time rethinking our study, examining relevant literature, and completely re-writing our paper to ensure that it meets the highest standards of quality and rigor.We are committed to producing high-quality research that contributes to the field and will take all necessary steps to achieve that goal. We appreciate your encouragement and will work hard to meet your expectations and the standards of the journal.Once again, thank you for your feedback, and we welcome any additional comments or suggestions you may have to improve our paper.AttachmentResponse to Reviewers.docxSubmitted filename: Click here for additional data file. 31 May 2023 <div> PONE-D-22-14268R1 </div>  <div> Information Technology Capability, Open Technological Innovation and Firm Growth </div>  <div> PLOS ONEDear Dr. Yao,Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE\u2019s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.Please submit your revised manuscript by Jul 15 2023 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at\u00a0 </div> A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'. <div> If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter.Please include the following items when submitting your revised manuscript:https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols.If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: We look forward to receiving your revised manuscript.Kind regards,Mohsin Shafi, Ph.D.Academic EditorPLOS ONEJournal Requirements:Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article\u2019s retracted status in the References list and also include a citation and full reference for the retraction notice.[Note: HTML markup is below. Please do not edit.]Reviewers' comments:Reviewer's Responses to Questions <font color=\"black\"> Comments to the Author </font> 1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the \u201cComments to the Author\u201d section, enter your conflict of interest statement in the \u201cConfidential to Editor\u201d section, and submit your \"Accept\" recommendation.Reviewer #1:\u00a0All comments have been addressedReviewer #4:\u00a0All comments have been addressed********** <font color=\"black\"> 2. Is the manuscript technically sound, and do the data support the conclusions? </font> The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1:\u00a0YesReviewer #4:\u00a0Partly********** <font color=\"black\"> 3. Has the statistical analysis been performed appropriately and rigorously?  </font> Reviewer #1:\u00a0YesReviewer #4:\u00a0Yes********** <font color=\"black\"> 4. Have the authors made all data underlying the findings in their manuscript fully available?PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data\u2014e.g. participant privacy or use of data from a third party\u2014those must be specified. </font> The Reviewer #1:\u00a0YesReviewer #4:\u00a0Yes********** <font color=\"black\"> 5. Is the manuscript presented in an intelligible fashion and written in standard English? </font> PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.Reviewer #1:\u00a0YesReviewer #4:\u00a0Yes********** <font color=\"black\"> 6. Review Comments to the Author </font> Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. Reviewer #1:\u00a0(No Response)Reviewer #4:\u00a0Thank you for submitting your article on the effects of Information Technology capability on firm growth in the context of open technological innovation. The findings are interesting and contribute to the literature on IT capability and firm growth. The research is also sound and has possible policy implications. All previous comments have been adequately addressed but it needs some minor revisions, which are recommended as follows:1. The methodology section is good; however, the authors should justify the use of regression analysis for the estimations. The study is based on a cross-sectional design which limits the ability to draw causal conclusions as mentioned by the authors under the limitations of the study.2. Please check Line 390 under \u201cSummary statistics and correlations\u201d, the Table number needs to be changed (Table IV instead of Table II). If possible, the authors may divide Table IV into two separate tables.3. The generalizability of the findings to other contexts may be limited due to a relatively smaller sample size. The Authors can further justify it or present it in the limitation section.********** <font color=\"black\"> 7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.If you choose \u201cno\u201d, your identity will remain anonymous but your review may still be made public.Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. </font> Yes:\u00a0Shabir AhmadReviewer #1:\u00a0Reviewer #4:\u00a0No**********https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at\u00a0figures@plos.org. Please note that Supporting Information files do not need this step.While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool,\u00a0 1 Jun 2023Response to ReviewersDear Editor and Reviewers:Thank you for your letter and the reviewers\u2019 comments on our manuscript titled \u201cInformation Technology Capability, Open Technological Innovation and Firm Growth\u201d (ID: PONE-D-22-14268R1). We appreciate the valuable and constructive comments, which have guided us to improve and refine our paper. We have meticulously reviewed the suggestions and incorporated the necessary changes, which are highlighted throughout the revised paper. The minor revisions made in the manuscript in response to the reviewers\u2019 comments are outlined below:Responds to the reviewers\u2019 comments:Reviewer #1No ResponseReviewer #2Thank you for submitting your article on the effects of Information Technology capability on firm growth in the context of open technological innovation. The findings are interesting and contribute to the literature on IT capability and firm growth. The research is also sound and has possible policy implications. All previous comments have been adequately addressed but it needs some minor revisions, which are recommended as follows:Comments:1. The methodology section is good; however, the authors should justify the use of regression analysis for the estimations. The study is based on a cross-sectional design which limits the ability to draw causal conclusions as mentioned by the authors under the limitations of the study.Reply: Thank you for your valuable feedback on our manuscript. We appreciate your positive remarks regarding the methodology section. We understand your concern regarding the use of regression analysis in our study, especially considering its cross-sectional design. We would like to address this concern and provide further justification for our choice of analysis.While we acknowledge that cross-sectional designs have inherent limitations in establishing causality, they are commonly used in many social science and survey research studies. In our case, a cross-sectional design was appropriate as it allowed us to capture a snapshot of the variables of interest at a specific point in time. Our primary goal was to examine the associations and relationships between these variables, rather than establish causal links.Regression analysis, despite its limitations in determining causality, remains a widely accepted statistical method for exploring relationships between variables. By utilizing regression analysis, we were able to assess the strength and direction of these relationships, controlling for potential confounding factors. This analytical approach allowed us to generate meaningful insights into the associations observed in our data.To ensure transparency, we have included a discussion in the limitations section of our manuscript, acknowledging the limitations of the cross-sectional design and the potential for reverse causality or unmeasured confounders. We emphasize the need for further longitudinal research to establish causal relationships and address these limitations.We hope that our explanation clarifies the rationale behind our use of regression analysis in a cross-sectional design. We appreciate your feedback and are open to any further suggestions or recommendations you may have to strengthen our manuscript.2. Please check Line 390 under \u201cSummary statistics and correlations\u201d, the Table number needs to be changed (Table IV instead of Table II). If possible, the authors may divide Table IV into two separate tables.Reply: Thank you for bringing this to our attention and providing valuable feedback on our manuscript. We apologize for the oversight in the labeling of the table. We have made the correction and ensure that the correct table number (Table IV) is reflected in the revised version of the manuscript.(Please see the edit texts on page 12 in Section 4.2)Regarding your suggestion to divide Table IV into two separate tables, we appreciate your recommendation. However, we have decided to maintain the current table formatting and present the data as a combined table. By doing so, we believe we can still present the information in an organized and concise manner, allowing readers to navigate and comprehend the data effectively. We have carefully considered your suggestion, but ultimately determined that preserving the existing table format would be more efficient for conveying the findings.3. The generalizability of the findings to other contexts may be limited due to a relatively smaller sample size. The Authors can further justify it or present it in the limitation section.Reply: Thank you for your insightful comments and feedback on our manuscript. We appreciate your concern regarding the generalizability of our findings due to the relatively smaller sample size. We agree that addressing the limitations of our study, including sample size, is crucial for providing a comprehensive understanding of the scope and applicability of our findings.In the revised version of our manuscript, we will explicitly address the limitations associated with the sample size in the limitation section. We will discuss the potential impact of the smaller sample size on the generalizability of our findings and acknowledge that caution should be exercised when extrapolating our results to broader populations or different contexts.While our study sample was carefully selected and represented a specific population of interest, we acknowledge that a larger and more diverse sample would strengthen the external validity of our findings. We will emphasize the need for future research to replicate our study using larger sample sizes and encompassing a wider range of participants, settings, or contexts to enhance the generalizability of the results.We appreciate your valuable input in helping us improve the clarity and completeness of our manuscript.(Please see the edit texts on page 17 in Section 5.4 Limitations and future research)AttachmentResponse to Reviewers.docxSubmitted filename: Click here for additional data file. 25 Aug 2023Information Technology Capability, Open Technological Innovation and Firm GrowthPONE-D-22-14268R2Dear Dr. Yao,We\u2019re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.Within one week, you\u2019ll receive an e-mail detailing the required amendments. When these have been addressed, you\u2019ll receive a formal acceptance letter and your manuscript will be scheduled for publication.http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org.An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at onepress@plos.org.If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they\u2019ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact Kind regards,Iv\u00e1n Barreda-Tarrazona, PhDAcademic EditorPLOS ONEAdditional Editor Comments :Reviewers' comments:Reviewer's Responses to Questions <font color=\"black\"> Comments to the Author </font> 1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the \u201cComments to the Author\u201d section, enter your conflict of interest statement in the \u201cConfidential to Editor\u201d section, and submit your \"Accept\" recommendation.Reviewer #2:\u00a0All comments have been addressed********** <font color=\"black\"> 2. Is the manuscript technically sound, and do the data support the conclusions? </font> The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #2:\u00a0Yes********** <font color=\"black\"> 3. Has the statistical analysis been performed appropriately and rigorously?  </font> Reviewer #2:\u00a0Yes********** <font color=\"black\"> 4. Have the authors made all data underlying the findings in their manuscript fully available?PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data\u2014e.g. participant privacy or use of data from a third party\u2014those must be specified. </font> The Reviewer #2:\u00a0Yes********** <font color=\"black\"> 5. Is the manuscript presented in an intelligible fashion and written in standard English? </font> PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.Reviewer #2:\u00a0Yes********** <font color=\"black\"> 6. Review Comments to the Author </font> Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. Reviewer #2:\u00a0Dear Authors,I have carefully reviewed your manuscript titled \"Information Technology Capability, Open Technological Innovation, and Firm Growth,\" and I appreciate the effort you have put into investigating this important topic.********** <font color=\"black\"> 7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.If you choose \u201cno\u201d, your identity will remain anonymous but your review may still be made public.Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. </font> Reviewer #2:\u00a0No**********AttachmentReview.docxSubmitted filename: Click here for additional data file. 16 Oct 2023PONE-D-22-14268R2 Information technology capability, open technological innovation and firm growth Dear Dr. Yao:I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. onepress@plos.org.If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact plosone@plos.org. If we can help with anything else, please email us at Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staffon behalf ofDr. Iv\u00e1n Barreda-Tarrazona Academic EditorPLOS ONE", "texts": ["The aim of this paper is to investigate the effects of information technology (IT) capability on firm growth in the context of open technological innovation. The paper utilized a logical deductive approach to develop hypotheses and analytical frameworks, and collected empirical data from 256 Chinese new ventures. Regression analysis and structural equation models were used to test the hypotheses and analyze the data. The results showed that IT capability, including flexibility and integration of information technology, significantly influenced firm growth, and open technological innovation partially mediated the relationship between IT flexibility and firm growth, and significantly mediated the relationship between IT integration and firm growth. The paper\u2019s limitations include the cross-sectional design, limited sample size, and potential unobserved variables such as organizational learning that could affect the relationship between IT capability and firm growth. The research is the first to investigate the effects of IT capability on firm growth based on the mediation of open technological innovation in China, contributing to the literature on IT capability and providing insights for managerial practice in the sharing economy era. In 2021, China adopted and implemented the \u201c14th Five-Year Plan\u201d to guide its economic development and the growth of firms over the next five years. This plan identifies \u201cinformation technology,\u201d \u201cinnovation,\u201d and \u201centrepreneurship\u201d as key drivers of economic growth, and places a strong emphasis on encouraging business innovation and supporting the formation and growth of new firms. Encouraging self-employment has emerged as a primary strategy to address the talent employment problem and promote stable economic growth and market economic vitality. In this context, new ventures play a crucial role in providing employment opportunities and promoting technological innovation, as well as contributing to social and economic development Reviewers' comments:Reviewer's Responses to Questions <font color=\"black\"> Comments to the Author1. Is the manuscript technically sound, and do the data support the conclusions? </font> The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1:\u00a0PartlyReviewer #2:\u00a0YesReviewer #3:\u00a0Partly********** <font color=\"black\"> 2. Has the statistical analysis been performed appropriately and rigorously?  </font> Reviewer #1:\u00a0NoReviewer #2:\u00a0YesReviewer #3:\u00a0No********** <font color=\"black\"> 3. Have the authors made all data underlying the findings in their manuscript fully available?PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data\u2014e.g. participant privacy or use of data from a third party\u2014those must be specified. </font> The Reviewer #1:\u00a0YesReviewer #2:\u00a0YesReviewer #3:\u00a0Yes********** <font color=\"black\"> 4. Is the manuscript presented in an intelligible fashion and written in standard English? </font> PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.Reviewer #1:\u00a0YesReviewer #2:\u00a0YesReviewer #3:\u00a0Yes********** <font color=\"black\"> 5. Review Comments to the Author </font> Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. Reviewer #1:\u00a0The authors' contribution is valuable and much appreciated, however, the manuscript needs some improvements as suggested below:1. Research Hypotheses: Logically there should be one more hypothesis for Open Technological Innovation and Firm Growth. In order to assess the mediation of Open Tech Innovation between the independent and dependent variables, the direct relationship between the mediator and the dependent variable must be examined first, and it should be statistically significant before assessing the indirect effect. Thus, it is mandatory to have an hypothesis to test the direct effect of mediator on dependent variable.2. Validity and Reliability: Though authors provided content validity and reliability statistics, it is desired to provide convergent and discriminant validity statistics as they are core components are scale validity in Structural Equation Modeling.3. The provided datafile seems corrupt showing random symbols instead of the data.Reviewer #2:\u00a0PLOS ONEInformation Technology Capability, Open Technological Innovation and Firm GrowthManuscript Number: PONE-D-22-14268Introduction and literature reviewIndeed, the introduction to this article is very well written, but I have a few recommendations for you that must be implemented.i.The introduction section must offer the study gap and objectives of the study.ii.Highlight current work contributions.iii.The selection of variables for the current study must be elaborated briefly.iv.Recent evidence should be presented to support the study's hypotheses.v.\u201cOn the other hand, novelty is essential for overcoming resource constraints and establishing a competitive advantage \u201d Pay attention to citations; it is not necessary to bring up unrelated facts.vi.Relevant references, including introduction, literature review, and hypothesis development, must be from within the last five years, except for theories and books.Conceptual modeli.I would recommend that you create a table before the research framework and mention previous studies from the last five years, including methodology, variables, and countries, and then draw your research gap.Methodologyi.In the field of social studies, is a sample size of 28.7 percent acceptable? strengthen your argument with references to pertinent sources.ii.Sample size calculation must be performed and reported with the use of Gpower 3.1 software.Variables and measuresCreate a table for variables and mentions, variable names, number of items, and previous authors.Variables No. of itemsAuthor's (previous authors)Discussion and Conclusioni.Compare the results of your study with previous studies in the discussion and conclusion section.ii.Contributions and limitation & future research should be inline.Reviewer #3:\u00a0The above points are fundamental and need to be addressed very carefully. I would strongly encourage the author(s) to take ample time to rethink their study, read more papers from good and reputed journals and try to completely re-write their study.********** <font color=\"black\"> 6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.If you choose \u201cno\u201d, your identity will remain anonymous but your review may still be made public.Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. </font> Reviewer #1:\u00a0NoReviewer #2:\u00a0NoReviewer #3:\u00a0No**********https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at\u00a0figures@plos.org. Please note that Supporting Information files do not need this step.While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool,\u00a0AttachmentPONE-D-22-14268_reviewer.docxSubmitted filename: Click here for additional data file.AttachmentReferee Report Plos One.docxSubmitted filename: Click here for additional data file. 22 Mar 2023Response to ReviewersDear Editor and Reviewers:Thank you for your letter and the reviewers\u2019 comments on our manuscript titled \u201cInformation Technology Capability, Open Technological Innovation and Firm Growth\u201d (ID: PONE-D-22-14268). We appreciate the valuable and constructive comments, which have guided us to improve and refine our paper. We have meticulously reviewed the suggestions and incorporated the necessary changes, which are highlighted in blue throughout the revised paper. The major revisions made in the manuscript in response to the reviewers\u2019 comments are outlined below:Responds to the reviewers\u2019 comments:Reviewer: 1The authors\u2019 contribution is valuable and much appreciated, however, the manuscript needs some improvements as suggested below:Comments:1. Research Hypotheses: Logically there should be one more hypothesis for Open Technological Innovation and Firm Growth. In order to assess the mediation of Open Tech Innovation between the independent and dependent variables, the direct relationship between the mediator and the dependent variable must be examined first, and it should be statistically significant before assessing the indirect effect. Thus, it is mandatory to have an hypothesis to test the direct effect of mediator on dependent variable.Reply: We appreciate your suggestion. In this paper, we have adopted the Baron & Kenny (1986) method and utilized the stepwise test regression coefficient to examine the mediating effect. The first step involves testing the overall impact of the independent variable on the dependent variable, followed by assessing the connection between the independent variable and the mediator variable in the second step. Finally, the third step involves evaluating the influence of both the independent and mediator variables on the dependent variable. Consequently, this paper does not examine the link between the mediator variable  and the dependent variable .2. Validity and Reliability: Though authors provided content validity and reliability statistics, it is desired to provide convergent and discriminant validity statistics as they are core components are scale validity in Structural Equation Modeling.Reply: As suggested by the reviewer, we have added the convergent and discriminant validity statistics to support reliability and validity test.(Please see the blue font on page 11 in Section 4.1)\u201c4.1 Reliability and validityTo ensure the proposed model\u2019s quality, it must be both statistically reliable and valid. Reliability means producing similar results across multiple tests under the same conditions. Cronbach\u2019s alpha is a widely used measure of reliability, and in this study, three measures were examined. The obtained values of 0.826, 0.784, and 0.780, respectively, all higher than 0.75, indicating high reliability of the proposed model.The validity of an analysis refers to the degree to which it accurately represents the intended information. Validity can be analyzed through content and construct validity analysis methods. Content validity evaluates the extent to which the questionnaire items accurately reflect the intended content. In this study, the questionnaire items were primarily drawn from the maturity scale, which had been reviewed and revised by the research team\u2019s professor. During the pilot test, no reports of misunderstandings were received, and interviewees indicated that the items were easy to understand, indicating satisfactory content validity. .The confirmatory factor analysis (CFA) is a powerful method used to assess construct validity. According to Campbell and Fiske\u2019s seminal work (1959), construct validity research typically examines the degree to which data provide, including convergent validity and discriminant validity.Table II presents the results of the CFA for assessing convergent validity. All factor loadings were significant and exceeded the recommended threshold of 0.5 , indicating strong convergent validity. To assess the model fit, several well-established goodness-of-fit indices were utilized, including the normed chi-square (\u03c72/df), the goodness-of-fit index (GFI), the adjusted goodness-of-fit index (AGFI), and the root mean square error of approximation (RMSEA) . In the measurement model, all indices exceeded their recommended thresholds, indicating sufficient construct validity.Discriminant validity is demonstrated when the square root of the average variance extracted (AVE) for a construct is greater than the corresponding inter-construct correlations. As Table III indicates, the square root of the AVE for each variable exceeded the intercorrelations, indicating sufficient discriminant validity.Table II. Convergent validity of the measurement modelVariable AVE CRIT flexibility (ITF) 0.560 0.835IT integration (ITI) 0.532 0.771Open technological innovation (OTI) 0.557 0.789 &#x0f063; 2/df=2.768 (\uff1c3); GFI\uff1e0.9; AGFI\uff1e0.9; RMSEA\uff1c0.05Notes: AVE is the average variance extracted; CR is the critical ratio; goodness-of-fit indices and recommended thresholds \ufffdTable III. Discriminant validity of the measurement modelVariable ITF ITI OTIIT flexibility (ITF) 0.749 IT integration (ITI) 0.528 0.729 Open technological innovation (OTI) 0.446 0.416 0.746Note: The square root of the AVE as a criteria\u201d3. The provided datafile seems corrupt showing random symbols instead of the data.Reply: Thanks for your careful checks. We are sorry for our carelessness. Based on your comments, we have re-uploaded the data.\u2003Reviewer: 2Comments:1. Introduction and literature reviewIndeed, the introduction to this article is very well written, but I have a few recommendations for you that must be implemented.i. The introduction section must offer the study gap and objectives of the study.Reply: We feel great thanks for your professional review work on our article. As you suggest, we strengthen the description of study gap and objectives of the study.\u201cPrevious research has largely focused on the impact of resource constraints on the growth of new ventures, which is a crucial concern . However, while resource constraints are undoubtedly a significant challenge for new ventures, there may be other factors that affect the performance and growth of firms that have not been fully explored. One of these factors could be the relationship between IT capability and performance.There have been several studies investigating the link between IT capability and firm performance, but the results have been inconclusive. Some studies have shown a positive relationship between IT capability and firm performance , while others have reported a no relationship . These mixed results suggest that there may be some missing links in the relationship between IT capability and firm performance that have not been fully explored.Therefore, this study aims to examine the influence of open technological innovation, which is one of the potential mediators, in the relationship between IT capability and firm growth. Open technological innovation refers to the use of external knowledge and resources to develop new products, services, and processes. The study will investigate whether open technological innovation can serve as a mediator between IT capability and firm growth, filling the gap in the existing literature.\u201d(Please see the blue font on page 3 in Section 1)ii. Highlight current work contributions.Reply: Thanks for your insight! As your suggestion, we have explicitly outlined the contributions of our current work.\u201cThis study contributes to the literature in three ways. Firstly, it explores the relationship between IT capability and firm growth, expanding the current research on firm growth that has primarily focused on IT investments. Secondly, the study proposes a conceptual model that considers the mediating variable of open technological innovation in this relationship. Lastly, this research is significant because while previous innovation management research has primarily focused on advanced economies, it provides insight into China, which has yet to be extensively explored.\u201d(Please see the blue font on page 4 in Section 1)iii. The selection of variables for the current study must be elaborated briefly.Reply: As your suggestion, we would like to clarify that the selection of variables has been elaborated in Section 2, i.e., \u201cLiterature Review and Hypotheses Development\u201d, which is further illustrated in Figure 1, i.e., \u201cTheoretical Framework and Conceptual Model\u201d.(Please see page 4-8 in Section 2)At the same time, a detailed discussion on variable measurement has been presented in Section 3.2, i.e., \u201cVariables and Measures\u201d.(Please see page 9-10 in Section 3.2)iv. Recent evidence should be presented to support the study\u2019s hypotheses.Reply: Thank you for your feedback regarding our study. We appreciate your suggestion to present recent evidence to support our study\u2019s hypotheses.In response to your comment, we have conducted a thorough review of recent literature in the field and have updated our study to include the most relevant and up-to-date evidence available. We have taken great care to ensure that our hypotheses are well-supported by the latest research in the field.We believe that this revision has significantly strengthened the theoretical foundation of our study, and we are confident that our hypotheses are now well-supported by the latest available evidence. We hope that this updated version of our study meets your expectations and addresses your concerns.(Please see \u201cLiterature review and hypotheses development\u201d on page 4-8 in Section 2)v. \u201cOn the other hand, novelty is essential for overcoming resource constraints and establishing a competitive advantage \u201d Pay attention to citations; it is not necessary to bring up unrelated facts.Reply: Thanks for your suggestion. As your recommendation, we have removed the mentioned sentence.(Please see page 3 in Section 1)vi. Relevant references, including introduction, literature review, and hypothesis development, must be from within the last five years, except for theories and books.Reply: Thanks for your suggestion! In response to your comment, we have conducted a thorough review of our references and have updated our study to include more recent and relevant references where appropriate. We have taken great care to ensure that our references meet your standards for academic rigor and quality.2. Conceptual modeli. I would recommend that you create a table before the research framework and mention previous studies from the last five years, including methodology, variables, and countries, and then draw your research gap.Reply: Thank you for your suggestion. The idea of creating a table before the research framework is very good. While including previous studies is important for contextualizing research, the format and organization of the literature review can vary depending on the research question and methodology being used.Furthermore, the suggestion to create a table before the research framework may not be the most effective way for us to organize the literature review in this paper, as it may not allow for a comprehensive discussion of the research gap and how the current study addresses it. As such, I will be structuring the literature review in a manner that aligns with the specific goals and objectives of the research project. Thank you again for your suggestion.(Please see page 4-8 in Section 2)3. Methodologyi. In the field of social studies, is a sample size of 28.7 percent acceptable? strengthen your argument with references to pertinent sources.Reply: Thanks for your insight! The percentage of valid data was calculated to be 28.7% based on the distribution of a full sample questionnaire. However, it should be noted that the recovered sample size was 4168, out of which only 2874 questionnaires were deemed valid, accounting for 68.95%. Upon analyzing this data, we have made necessary modifications to the article.(Please see the blue font on page 8 in Section 3.1)ii. Sample size calculation must be performed and reported with the use of Gpower 3.1 software.Reply: Thanks for your suggestion! In Section 3.1, we have provided a report on the sample data. Moreover, a detailed descriptive statistical analysis of the data has been carried out and the findings have been presented in Table 1.(Please see the blue font on page 8 in Section 3.1)4. Variables and measuresi. Create a table for variables and mentions, variable names, number of items, and previous authors.Variables No. of items Author's (previous authors)Reply: Thank you for your helpful suggestion. We appreciate your input on this matter. While we agree that creating a table for the variables and elements, variable names, number of items, and previous authors would be useful, we regret to inform you that we are unable to do so due to space limitations. However, we have provided detailed information on the names, measurement methods, and reference sources of each variable in the main text, which we believe will adequately address the yours concerns. We hope that you will find our approach acceptable(Please see the blue font on page 9-10 in Section 3.2)5. Discussion and Conclusioni. Compare the results of your study with previous studies in the discussion and conclusion section.Reply: Thank you for your helpful suggestion. We acknowledge the importance of situating our findings in the context of previous research in the discussion and conclusion section. In the revised manuscript, we will provide a comprehensive review of the relevant literature and compare our results with those of previous studies. We will highlight the similarities and differences between our findings and those of previous research, and discuss the implications of our results for theory and practice. We believe that this will enhance the contribution of our study to the literature on innovation management and provide a more nuanced understanding of the relationship between IT capability, open technological innovation, and firm growth. We appreciate your input and look forward to incorporating your feedback into the revised manuscript.\u201cThis study contributes to the existing literature on the relationship between IT capability and firm growth by examining the mediating effects of open technological innovation. Our findings are consistent with previous research that suggests IT capability positively influences firm growth . However, our study provides a more nuanced understanding of this relationship by showing that open technological innovation plays a partial mediating role in this relationship. Specifically, our results suggest that new ventures that are able to leverage open technological innovation can better translate their IT capabilities, such as IT flexibility and IT integrality, into firm growth.This study also extends the literature on open innovation by highlighting its importance in the context of new ventures. Our findings suggest that open technological innovation can be a valuable mechanism for new ventures to access external knowledge, resources, and networks, which can help them overcome resource constraints and compete with established firms . Furthermore, our study shows that open technological innovation can help new ventures to translate their IT capabilities into firm growth. This highlights the importance of managing innovation holistically and considering the interactions between different types of innovation.\u201d(Please see the blue font on page 15 in Section 5.1)ii. Contributions and limitation & future research should be inline.Reply: We appreciate the reviewer\u2019s valuable feedback on our paper. We have made several modifications to the paper. Specifically, we have revised the conclusion section to more clearly highlight our contributions and limitations, and to provide a more focused and coherent discussion of the future research directions.In the revised conclusion section, we first summarize our key findings and contributions, including the relationship between IT capability, open technological innovation, and firm growth, and the important role of managing innovation holistically. We then highlight the limitations of our study, including the cross-sectional design and potential sampling bias. Finally, we provide a clear and focused discussion of the future research directions, including the need for longitudinal studies, industry-specific studies, and studies that examine the role of other mediators in the relationship between IT capability and firm growth.Overall, we believe that these modifications have help to more clearly and coherently present the contributions, limitations, and future research directions of our study.(Please see the blue font on page 15-17 in Section 5)\u2003Reviewer: 3This study investigates the influence of open technological innovation, one of the potential mediators, in the link between IT capability and firm growth in China by using cross-sectional data of 259 ventures. The study finds that IT capability, including flexibility and integration of information technology, has a significant factor in firm advancement. Also, results confirm that open technological innovation plays a significant mediating role between IT integration and firm growth. The study recommended that IT integration needs the Internet-information-system can be flawlessly combined with the system of innovation partners, and can easily access, exchange and aggregate the resources and data of innovation partners, so as to integrate and absorb.Although the paper does follow a regular type of analysis for paper implementing theoretical/empirical mechanisms studies, I was not really impressed by the total picture of it. After all, the author(s) themselves recognize that their novelty comes from the fact that the theoretical mechanisms have not dealt with this country sample. I am afraid though that the paper in its current form is way too underdeveloped both theoretically and empirically. It seems that the author(s)would greatly benefit by submitting their work to some conferences to get feedback and to their colleagues for some reviews. There could be merit in what you are trying to explain, to my understanding open technological innovation and how/when it affects positively or not on firm growth and capability. Even then, the paper suffers from a number of weaknesses that must be explicitly considered in improving the picture of it. In particular:Comments:1. The introduction includes one and half page that do not communicate well with each other. The introduction is mostly focused on general background, while it should be specific with target firms and country. The work is not well written and shows flaws in the structuring of logical arguments without highlighting the original pizzle. Authors need to make clearer what we have learned from previous studies and what we are uncertain about. There are many more! this research needs to build on these and demonstrates very clearly how you build on and extend this stream of research. The second research question is also not new. For example, the study indicated that using IT capacity instead of IT investment capacity is significant contribution however this couldn\u2019t unique contribution. Because investment and capacity can be used robust analysis to allow you to make better decisions. Also, there are studies who investigate the relationship between IT capacity and firm performance, e.g., Liu et al. . It is widely accepted that the relationship between IT innovation and firm growth and there are numerous studies on this. In what ways do your conceptualizations advance this literature? Also, the target country is China, how this study could impact globally. Authors should explain what the importance of this study is. I mean the paper should incorporate clearer motivation and background of the issue and its importance.Reply: Thank you for your comment. We understand the importance of providing a clear motivation and background of the issue in our paper.Our study aims to examine the influence of open technological innovation as a mediator between IT capability and firm growth for new ventures in China. Given China\u2019s emphasis on promoting innovation and entrepreneurship in its 14th Five-Year Plan, and the increasing importance of IT capability and open technological innovation in the digital economy, our study has important implications for new venture development and economic growth in China and globally.Moreover, our study contributes to the existing literature by expanding current research on firm growth, proposing a conceptual model that considers the mediating variable of open technological innovation, and providing unique insights into the challenges and opportunities facing new ventures in China.Therefore, we will ensure that our paper clearly communicates the motivation and background of the issue, and the significance of our study for new venture development, economic growth, and innovation management in China and beyond.\u201c1. IntroductionIn 2021, China adopted and implemented the \u201c14th Five-Year Plan\u201d to guide its economic development and the growth of firms over the next five years. This plan identifies \u201cinformation technology,\u201d \u201cinnovation,\u201d and \u201centrepreneurship\u201d as key drivers of economic growth, and places a strong emphasis on encouraging business innovation and supporting the formation and growth of new firms. Encouraging self-employment has emerged as a primary strategy to address the talent employment problem and promote stable economic growth and market economic vitality. In this context, new ventures play a crucial role in providing employment opportunities and promoting technological innovation, as well as contributing to social and economic development .Despite their potential, new ventures often face challenges in acquiring external resources due to their \u201cnewness,\u201d lack of full performance records, and information asymmetry, which can exacerbate resource constraints and create uncertainty in their growth trajectory . Academic research has explored various theories and strategies to address these challenges, including resource integration and patching . However, new ventures still struggle to meet their growth demands with internal resources alone, often requiring deep relationships with external organizations and resource repurposing to drive innovation . Additionally, new ventures must prioritize innovation to break existing corporate monopolies and adapt to rapidly changing external circumstances, thereby minimizing the risks associated with their relative lack of experience and expertise .In the current era characterized by the Internet and the digital economy, technology innovation is accelerating, and demand is rapidly evolving. The complexity, systematicity, timeliness, and high investment required for innovation have made a significant impact on innovation agents. However, with the advancement of Internet technology and the transformation of corporate innovation concepts, new ventures can aggregate innovation resources worldwide by building information technology capabilities. This approach breaks the limits of traditional ownership and achieves low cost and high efficiency in innovation at a fast pace. Open technological innovation involves organizations that go beyond their original organizational boundaries to tap into external sources of innovation knowledge. They can effectively integrate these resources through internal organizational processes, which enables them to turn them into technological innovation achievements that add value .Organizational innovation openness is considered a fundamental component for determining the success of enterprises in open technological innovation research. Meanwhile, the industrial environment is changing rapidly, and new ventures face new challenges as a result of the rapid growth of internet-based information technology . The economic environment has dramatically changed, and innovation efforts have become more complex, with a clear cross-domain tendency. Firms are struggling to meet the new requirements with their existing resources, and using external resources for open innovation has become a significant consideration for them . Several factors, such as perceived cost savings and income generation, external pressure, organizational preparedness, and perceived ease of use, have a significant impact on IT investments for new ventures . In new ventures, IT investments may vary from IT investment in big enterprises since a smaller number of people have decision-making responsibilities, standard procedures are not created, and long-term planning is restricted. Furthermore, there is a higher dependency on external IT professionals in new ventures . However, IT capability may help new ventures survive in the long run by providing access to external knowledge and financial resources, building trust and legitimacy through widespread information transmission, and improving social network links . New environmental conditions also enable new ventures to overcome resource constraints in the innovation process by improving their IT capability to achieve a long-term competitive advantage .Previous research has largely focused on the impact of resource constraints on the growth of new ventures, which is a crucial concern . However, while resource constraints are undoubtedly a significant challenge for new ventures, there may be other factors that affect the performance and growth of firms that have not been fully explored. One of these factors could be the relationship between IT capability and performance. There have been several studies investigating the link between IT capability and firm performance, but the results have been inconclusive. Some studies have shown a positive relationship between IT capability and firm performance , while others have reported a no relationship . These mixed results suggest that there may be some missing links in the relationship between IT capability and firm performance that have not been fully explored.Therefore, this study aims to examine the influence of open technological innovation, which is one of the potential mediators, in the relationship between IT capability and firm growth. Open technological innovation refers to the use of external knowledge and resources to develop new products, services, and processes. The study will investigate whether open technological innovation can serve as a mediator between IT capability and firm growth, filling the gap in the existing literature.This study contributes to the literature in three ways. Firstly, it explores the relationship between IT capability and firm growth, expanding the current research on firm growth that has primarily focused on IT investments. Secondly, the study proposes a conceptual model that considers the mediating variable of open technological innovation in this relationship. Lastly, this research is significant because while previous innovation management research has primarily focused on advanced economies, it provides insight into China, which has yet to be extensively explored.The structure of the paper is organized as follows. Section two provides a literature review and develops the hypotheses. Section three shows the data and methods employed in the empirical study. Section four presents the empirical results, and Section five concludes with some important contributions and limitations of the study and directions for future research.\u201d(Please see the blue font on page 3-4 in Section 1)2. There is no theoretical model or offers no innovation since it has been well established in the relevant literature. Your argumentation of the hypotheses is not sufficient. Your need to develop a theoretical framework and follow the same line to develop all the three arguments. At the moment, there is really nothing useful there. It is not convincing at all. Also, your hypotheses refer to Chinese firms - there is no generalization there. e.Reply: Thank you for your suggestion. We acknowledge that our current hypotheses are not sufficiently grounded in a theoretical framework, and we recognize the importance of developing a more comprehensive argumentation to support our research. We will take steps to address this by conducting further research and analysis to strengthen our theoretical framework and develop a more convincing case for our study.(Please see \u201cLiterature review and hypotheses development\u201d on page 4-8 in Section 2)Regarding the generalizability of our hypotheses to firms outside of China, we agree that it is important to consider the context of our study and the potential limitations in generalizing our findings to other settings. We will include a discussion in our paper about the potential applicability of our results to other regions or contexts, as well as the limitations of our study in this regard.(Please see \u201cLimitations and future research\u201d on page 17 in Section 5.4)3. It would be helpful if you could relate your hypotheses in a theoretical framework and follow this up with a clearly pronounced hypotheses that relates to the theoretical argument made prior. The operationalisation of the hypothesis is not part and parcel of why you argue this particular hypothesis and should be presented in the methods section. The selection and justifications of the variables should be further discussed with supporting references.Reply: Thanks for your insight! We appreciate your suggestion to relate our hypotheses to a theoretical framework and provide a clearer justification for our argument. We recognize the importance of a well-grounded theoretical argument and will work to develop a more comprehensive framework to support our hypotheses.We also agree with your suggestion to separate the operationalization of our hypotheses from the theoretical argument and to present this in the methods section. We will provide a clear and detailed explanation of the methods used to operationalize our hypotheses, as well as the selection and justification of the variables.(Please see \u201cVariables and measures\u201d on page 9-10 in Section 3.2)4. The study used the survey data of 256 new ventures out of 2854 valid surveys. However, there should discussion about the validity of the surveys. Also, why chosen provinces were Beijing, Tianjin, Shandong Jiangsu and Hebei?Reply: Thank you for your feedback. First, as your suggestion, we have added the analysis of reliability and validity.Second, with regards to the selection of provinces in the study, we chose Beijing, Tianjin, Shandong, Jiangsu, and Hebei because they are among the most economically developed and populous provinces in China, and have a high concentration of new ventures. These provinces also represent different regions and industries in China, which makes the findings more generalizable to other parts of the country. Additionally, we acknowledge that we have had access to data from these provinces, making it easier to conduct the research.5. In addition, the model could be used to identify the relationship between the variables with existing literature. For example, the section 3.2 should be linked with hypotheses and expected connection between the variables. Although, authors mentioned that they followed previous studies, Rai, 2010; Cui, 2015; Bi et al., 2017, for variables selection.Reply: Thanks for your insight! We appreciate your suggestion to link section 3.2 with hypotheses and expected connections between the variables. In the revised version of the paper, we will provide a more detailed explanation of how our study builds upon existing literature and link the variables with our hypotheses. We will also discuss how our findings compare with previous studies, to provide more context and strengthen the theoretical foundations of our research. We believe that these revisions will enhance the clarity and rigor of our paper and make it more useful for future research in this field.(Please see \u201cVariables and measures\u201d on page 9-10 in Section 3.2)6. The paper at its current version is a-theoretical. There is not a single theory you are basing your arguments or attempting to develop and inform through your research. Your paper could be drawing from International Business/finance theory (innovation) and learning from firm growth. It needs to draw on particular mechanisms and explain how/when/why growth in the domestic context is enhances when firms use IT capacity.Reply: Thanks for your insight! We agree that our paper can benefit from a stronger theoretical foundation. In the revised version of the paper, we will explicitly articulate the theoretical underpinnings of our study and demonstrate how they inform our research questions, hypotheses, and analysis.Specifically, our paper draws on several theoretical perspectives from the fields of international business, finance, and innovation to explore the relationship between IT capability, open technological innovation, and new venture growth in the Chinese context.From an international business perspective, our study is informed by the resource-based view (RBV) of the firm, which emphasizes the strategic importance of organizational resources and capabilities in creating and sustaining competitive advantage. In particular, our study focuses on the role of IT capability as a key resource that enables new ventures to leverage external knowledge and expertise, which can enhance innovation and improve growth performance.From a finance perspective, our study is informed by the capital structure theory, which suggests that firms with stronger IT capability are more likely to obtain external financing and thereby achieve greater growth potential.Lastly, from an innovation perspective, our study builds on the open innovation paradigm, which emphasizes the importance of external knowledge sources and collaboration in driving innovation and firm growth.We will further elaborate on these theoretical perspectives in the revised version of the paper and provide a more detailed explanation of how they inform our study. We will also explicitly outline the specific mechanisms through which IT capability can enhance new venture growth in the Chinese context, taking into account the unique institutional and cultural factors at play.(Please see \u201cIT capability and firm growth\u201d on page 4-6 in Section 2.1)7. Empirical findings supports the hypotheses however, there should be critical analysis and supported with existing literature. Therefore, the author is suggested to reconstruct the theoretical and empirical model to become more realistic.Reply: Thank you for your valuable feedback regarding our study. We appreciate your constructive criticism, and we will take your suggestions into consideration as we revise and improve our paper.In response to your comment, we revisit the literature review section of the paper to identify gaps and limitations in the existing literature, and to better support our theoretical and empirical models with relevant literature. We also provide a more detailed and critical analysis of our empirical findings, highlighting the strengths and limitations of our study\u2019s approach and analysis.Moreover, we carefully consider your suggestion to reconstruct our theoretical and empirical models to ensure that they are more realistic and aligned with existing literature. We revisit our research questions, hypotheses, and variables, and we will refine them based on your feedback to better represent the phenomena under investigation.8. Conclusion should not repetition of the results. Policy implications are not very clear.Reply: Thanks for your comments! Our revised conclusion and implications section now more clearly and concisely summarizes our key findings and provides actionable recommendations for future research and practical applications. We have made sure to avoid any repetition of our results, and instead, we have highlighted the implications of our findings in a more focused and relevant manner.We have also ensured that our policy implications are clear and actionable, and we have directly linked them to our research findings. Our revised implications section is now more closely aligned with our research objectives, and we believe that it provides a stronger and more meaningful conclusion to our study.(Please see \u201cConclusions and discussion\u201d on page 15-17 in Section 5)9. The above points are fundamental and need to be addressed very carefully. I would strongly encourage the author(s) to take ample time to rethink their study, read more papers from good and reputed journals and try to completely re-write their study. I wish you all the best of luck.Reply: Thank you for taking the time to review our paper and for sharing your thoughts with us. We appreciate your comments and are grateful for your insights.We understand the importance of carefully addressing all fundamental issues in our study and appreciate your feedback regarding the need to read more papers from good and reputed journals. We will take your advice to heart and spend ample time rethinking our study, examining relevant literature, and completely re-writing our paper to ensure that it meets the highest standards of quality and rigor.We are committed to producing high-quality research that contributes to the field and will take all necessary steps to achieve that goal. We appreciate your encouragement and will work hard to meet your expectations and the standards of the journal.Once again, thank you for your feedback, and we welcome any additional comments or suggestions you may have to improve our paper.AttachmentResponse to Reviewers.docxSubmitted filename: Click here for additional data file. 31 May 2023 <div> PONE-D-22-14268R1 </div>  <div> Information Technology Capability, Open Technological Innovation and Firm Growth </div>  <div> PLOS ONEDear Dr. Yao,Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE\u2019s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.Please submit your revised manuscript by Jul 15 2023 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at\u00a0 </div> A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'. <div> If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter.Please include the following items when submitting your revised manuscript:https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols.If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: We look forward to receiving your revised manuscript.Kind regards,Mohsin Shafi, Ph.D.Academic EditorPLOS ONEJournal Requirements:Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article\u2019s retracted status in the References list and also include a citation and full reference for the retraction notice.[Note: HTML markup is below. Please do not edit.]Reviewers' comments:Reviewer's Responses to Questions <font color=\"black\"> Comments to the Author </font> 1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the \u201cComments to the Author\u201d section, enter your conflict of interest statement in the \u201cConfidential to Editor\u201d section, and submit your \"Accept\" recommendation.Reviewer #1:\u00a0All comments have been addressedReviewer #4:\u00a0All comments have been addressed********** <font color=\"black\"> 2. Is the manuscript technically sound, and do the data support the conclusions? </font> The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1:\u00a0YesReviewer #4:\u00a0Partly********** <font color=\"black\"> 3. Has the statistical analysis been performed appropriately and rigorously?  </font> Reviewer #1:\u00a0YesReviewer #4:\u00a0Yes********** <font color=\"black\"> 4. Have the authors made all data underlying the findings in their manuscript fully available?PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data\u2014e.g. participant privacy or use of data from a third party\u2014those must be specified. </font> The Reviewer #1:\u00a0YesReviewer #4:\u00a0Yes********** <font color=\"black\"> 5. Is the manuscript presented in an intelligible fashion and written in standard English? </font> PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.Reviewer #1:\u00a0YesReviewer #4:\u00a0Yes********** <font color=\"black\"> 6. Review Comments to the Author </font> Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. Reviewer #1:\u00a0(No Response)Reviewer #4:\u00a0Thank you for submitting your article on the effects of Information Technology capability on firm growth in the context of open technological innovation. The findings are interesting and contribute to the literature on IT capability and firm growth. The research is also sound and has possible policy implications. All previous comments have been adequately addressed but it needs some minor revisions, which are recommended as follows:1. The methodology section is good; however, the authors should justify the use of regression analysis for the estimations. The study is based on a cross-sectional design which limits the ability to draw causal conclusions as mentioned by the authors under the limitations of the study.2. Please check Line 390 under \u201cSummary statistics and correlations\u201d, the Table number needs to be changed (Table IV instead of Table II). If possible, the authors may divide Table IV into two separate tables.3. The generalizability of the findings to other contexts may be limited due to a relatively smaller sample size. The Authors can further justify it or present it in the limitation section.********** <font color=\"black\"> 7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.If you choose \u201cno\u201d, your identity will remain anonymous but your review may still be made public.Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. </font> Yes:\u00a0Shabir AhmadReviewer #1:\u00a0Reviewer #4:\u00a0No**********https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at\u00a0figures@plos.org. Please note that Supporting Information files do not need this step.While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool,\u00a0 1 Jun 2023Response to ReviewersDear Editor and Reviewers:Thank you for your letter and the reviewers\u2019 comments on our manuscript titled \u201cInformation Technology Capability, Open Technological Innovation and Firm Growth\u201d (ID: PONE-D-22-14268R1). We appreciate the valuable and constructive comments, which have guided us to improve and refine our paper. We have meticulously reviewed the suggestions and incorporated the necessary changes, which are highlighted throughout the revised paper. The minor revisions made in the manuscript in response to the reviewers\u2019 comments are outlined below:Responds to the reviewers\u2019 comments:Reviewer #1No ResponseReviewer #2Thank you for submitting your article on the effects of Information Technology capability on firm growth in the context of open technological innovation. The findings are interesting and contribute to the literature on IT capability and firm growth. The research is also sound and has possible policy implications. All previous comments have been adequately addressed but it needs some minor revisions, which are recommended as follows:Comments:1. The methodology section is good; however, the authors should justify the use of regression analysis for the estimations. The study is based on a cross-sectional design which limits the ability to draw causal conclusions as mentioned by the authors under the limitations of the study.Reply: Thank you for your valuable feedback on our manuscript. We appreciate your positive remarks regarding the methodology section. We understand your concern regarding the use of regression analysis in our study, especially considering its cross-sectional design. We would like to address this concern and provide further justification for our choice of analysis.While we acknowledge that cross-sectional designs have inherent limitations in establishing causality, they are commonly used in many social science and survey research studies. In our case, a cross-sectional design was appropriate as it allowed us to capture a snapshot of the variables of interest at a specific point in time. Our primary goal was to examine the associations and relationships between these variables, rather than establish causal links.Regression analysis, despite its limitations in determining causality, remains a widely accepted statistical method for exploring relationships between variables. By utilizing regression analysis, we were able to assess the strength and direction of these relationships, controlling for potential confounding factors. This analytical approach allowed us to generate meaningful insights into the associations observed in our data.To ensure transparency, we have included a discussion in the limitations section of our manuscript, acknowledging the limitations of the cross-sectional design and the potential for reverse causality or unmeasured confounders. We emphasize the need for further longitudinal research to establish causal relationships and address these limitations.We hope that our explanation clarifies the rationale behind our use of regression analysis in a cross-sectional design. We appreciate your feedback and are open to any further suggestions or recommendations you may have to strengthen our manuscript.2. Please check Line 390 under \u201cSummary statistics and correlations\u201d, the Table number needs to be changed (Table IV instead of Table II). If possible, the authors may divide Table IV into two separate tables.Reply: Thank you for bringing this to our attention and providing valuable feedback on our manuscript. We apologize for the oversight in the labeling of the table. We have made the correction and ensure that the correct table number (Table IV) is reflected in the revised version of the manuscript.(Please see the edit texts on page 12 in Section 4.2)Regarding your suggestion to divide Table IV into two separate tables, we appreciate your recommendation. However, we have decided to maintain the current table formatting and present the data as a combined table. By doing so, we believe we can still present the information in an organized and concise manner, allowing readers to navigate and comprehend the data effectively. We have carefully considered your suggestion, but ultimately determined that preserving the existing table format would be more efficient for conveying the findings.3. The generalizability of the findings to other contexts may be limited due to a relatively smaller sample size. The Authors can further justify it or present it in the limitation section.Reply: Thank you for your insightful comments and feedback on our manuscript. We appreciate your concern regarding the generalizability of our findings due to the relatively smaller sample size. We agree that addressing the limitations of our study, including sample size, is crucial for providing a comprehensive understanding of the scope and applicability of our findings.In the revised version of our manuscript, we will explicitly address the limitations associated with the sample size in the limitation section. We will discuss the potential impact of the smaller sample size on the generalizability of our findings and acknowledge that caution should be exercised when extrapolating our results to broader populations or different contexts.While our study sample was carefully selected and represented a specific population of interest, we acknowledge that a larger and more diverse sample would strengthen the external validity of our findings. We will emphasize the need for future research to replicate our study using larger sample sizes and encompassing a wider range of participants, settings, or contexts to enhance the generalizability of the results.We appreciate your valuable input in helping us improve the clarity and completeness of our manuscript.(Please see the edit texts on page 17 in Section 5.4 Limitations and future research)AttachmentResponse to Reviewers.docxSubmitted filename: Click here for additional data file. 25 Aug 2023Information Technology Capability, Open Technological Innovation and Firm GrowthPONE-D-22-14268R2Dear Dr. Yao,We\u2019re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.Within one week, you\u2019ll receive an e-mail detailing the required amendments. When these have been addressed, you\u2019ll receive a formal acceptance letter and your manuscript will be scheduled for publication.http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org.An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at onepress@plos.org.If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they\u2019ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact Kind regards,Iv\u00e1n Barreda-Tarrazona, PhDAcademic EditorPLOS ONEAdditional Editor Comments :Reviewers' comments:Reviewer's Responses to Questions <font color=\"black\"> Comments to the Author </font> 1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the \u201cComments to the Author\u201d section, enter your conflict of interest statement in the \u201cConfidential to Editor\u201d section, and submit your \"Accept\" recommendation.Reviewer #2:\u00a0All comments have been addressed********** <font color=\"black\"> 2. Is the manuscript technically sound, and do the data support the conclusions? </font> The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #2:\u00a0Yes********** <font color=\"black\"> 3. Has the statistical analysis been performed appropriately and rigorously?  </font> Reviewer #2:\u00a0Yes********** <font color=\"black\"> 4. Have the authors made all data underlying the findings in their manuscript fully available?PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data\u2014e.g. participant privacy or use of data from a third party\u2014those must be specified. </font> The Reviewer #2:\u00a0Yes********** <font color=\"black\"> 5. Is the manuscript presented in an intelligible fashion and written in standard English? </font> PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.Reviewer #2:\u00a0Yes********** <font color=\"black\"> 6. Review Comments to the Author </font> Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. Reviewer #2:\u00a0Dear Authors,I have carefully reviewed your manuscript titled \"Information Technology Capability, Open Technological Innovation, and Firm Growth,\" and I appreciate the effort you have put into investigating this important topic.********** <font color=\"black\"> 7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.If you choose \u201cno\u201d, your identity will remain anonymous but your review may still be made public.Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. </font> Reviewer #2:\u00a0No**********AttachmentReview.docxSubmitted filename: Click here for additional data file. 16 Oct 2023PONE-D-22-14268R2 Information technology capability, open technological innovation and firm growth Dear Dr. Yao:I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. onepress@plos.org.If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact plosone@plos.org. If we can help with anything else, please email us at Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staffon behalf ofDr. Iv\u00e1n Barreda-Tarrazona Academic EditorPLOS ONE"]}
{"representative": "Clostridiodes difficile (C. difficile) infection. A barrier to increasing Fidaxomicin usage has been the medication\u2019s potential high co-pay. The objective of this study was to evaluate the discharge success rate and financial/co-pay barriers for inpatients initiated on Fidaxomicin at our institution.Current IDSA guidelines prefer Fidaxomicin for initial and first recurrent C. difficile during 2022. For inpatient discharges, a transitions of care (TOC) pharmacy evaluation is available for high co-pay medications. Charts were retrospectively reviewed for demographic, clinical, insurance, and pharmacy data.\u202f\u202fThe primary outcome was the proportion of patients successfully discharged on Fidaxomicin. Secondary outcomes included proportion of patients with co-pays >$50 and direct out-of-pocket patient cost after TOC pharmacy intervention.Our cohort consisted of inpatients that received Fidaxomicin for the treatment of 29 patients were initiated on Fidaxomicin for CDI treatment in 2022. The majority of patients had Medicare (62%), a prior history of CDI (75%), were immunocompromised (55%), and met non-severe IDSA criteria (62%) (Table 1). 7% (2/29) switched to oral vancomycin early due to ID consult or stewardship recommendations and 28% (8/29) completed the course prior to discharge . All the remaining patients (19/19) discharged to extended care or home were able to be discharged on Fidaxomicin.74% (14/19) of patients discharged on Fidaxomicin had TOC pharmacy evaluations with co-pay data available . 50% of these patients (7/14) had high co-pays  with a mean co-pay of $470.25 (range $65-1384.95) (Table 2). The majority (5/7) of the \u201chigh co-pay\u201d group had Medicare; three Medicare patients had out-of-pocket cost reduced after TOC pharmacy intervention (Table 2). Post-TOC intervention, the mean patient out-of-pocket cost was $181.20 (range $0-566.44).C. difficile were able to be \u201csuccessfully\u201d discharged with the medication. However, the co-pay remains potentially high for certain individuals, particularly those with Medicare and prolonged tapers. TOC pharmacy evaluations, if available, are critical for financial assistance prior to discharge.All inpatients continued on Fidaxomicin for the treatment of All Authors: No reported disclosures", "texts": ["Clostridiodes difficile (C. difficile) infection. A barrier to increasing Fidaxomicin usage has been the medication\u2019s potential high co-pay. The objective of this study was to evaluate the discharge success rate and financial/co-pay barriers for inpatients initiated on Fidaxomicin at our institution.Current IDSA guidelines prefer Fidaxomicin for initial and first recurrent C. difficile during 2022. For inpatient discharges, a transitions of care (TOC) pharmacy evaluation is available for high co-pay medications. Charts were retrospectively reviewed for demographic, clinical, insurance, and pharmacy data.\u202f\u202fThe primary outcome was the proportion of patients successfully discharged on Fidaxomicin. Secondary outcomes included proportion of patients with co-pays >$50 and direct out-of-pocket patient cost after TOC pharmacy intervention.Our cohort consisted of inpatients that received Fidaxomicin for the treatment of 29 patients were initiated on Fidaxomicin for CDI treatment in 2022. The majority of patients had Medicare (62%), a prior history of CDI (75%), were immunocompromised (55%), and met non-severe IDSA criteria (62%) (Table 1). 7% (2/29) switched to oral vancomycin early due to ID consult or stewardship recommendations and 28% (8/29) completed the course prior to discharge . All the remaining patients (19/19) discharged to extended care or home were able to be discharged on Fidaxomicin.74% (14/19) of patients discharged on Fidaxomicin had TOC pharmacy evaluations with co-pay data available . 50% of these patients (7/14) had high co-pays  with a mean co-pay of $470.25 (range $65-1384.95) (Table 2). The majority (5/7) of the \u201chigh co-pay\u201d group had Medicare; three Medicare patients had out-of-pocket cost reduced after TOC pharmacy intervention (Table 2). Post-TOC intervention, the mean patient out-of-pocket cost was $181.20 (range $0-566.44).C. difficile were able to be \u201csuccessfully\u201d discharged with the medication. However, the co-pay remains potentially high for certain individuals, particularly those with Medicare and prolonged tapers. TOC pharmacy evaluations, if available, are critical for financial assistance prior to discharge.All inpatients continued on Fidaxomicin for the treatment of All Authors: No reported disclosures"]}
{"representative": "Static and DTP radiomics features were extracted from baseline static PET images and DTP Ki parametric maps. Spearman\u2019s rank correlations were calculated between static and DTP features to identify features with potential additional information. We first employed univariate analysis to determine correlations between individual features, and subsequently utilized multivariate analysis to derive predictive models utilizing DTP and static radiomics features before and after ComBat harmonization. For multivariate modeling, we utilized both the minimum redundancy maximum relevance feature selection technique and the XGBoost classifier. To evaluate our model, we partitioned the patient datasets into training/validation and testing sets using an 80/20% split. Different metrics for classification including area under the curve (AUC), sensitivity (SEN), specificity (SPE), and accuracy (ACC) were reported in test sets.We analyzed 126 lesions from 45 lymphoma patients (responding \u03c1\u2009<\u20090.7); all the other 33 features showed high correlations (\u03c1\u2009\u2265\u20090.7). In univariate modeling, no significant difference between AUC of DTP and static features was observed. GLRLM_RLNU from static features demonstrated a strong correlation  with therapy response. The most predictive DTP features were GLCM_Energy, GLCM_Entropy, and Uniformity, each with AUC\u2009=\u20090.73, p value\u2009=\u20090.0001, and q value\u2009<\u20090.0005. In multivariate analysis, the mean ranges of AUCs increased following harmonization. Use of harmonization plus combining DTP and static features was shown to provide significantly improved predictions . All models depicted significant performance in terms of AUC, ACC, SEN, and SPE .Via Spearman\u2019s rank correlations, there was negligible to moderate correlation between 32 out of 65 DTP features and some static features (Our results demonstrate significant value in harmonization of radiomics features as well as combining DTP and static radiomics models for predicting response to chemotherapy in lymphoma patients.The online version contains supplementary material available at 10.1186/s13550-023-01022-0. In clinical oncology, medical imaging technologies have evolved from simple diagnostic tools to a source of valuable clinical information over the years , 2. In a18F]FDG or other PET radiopharmaceutical uptake patterns within a tumor have been characterized by identifying imaging features  reflecting biological characteristics, such as cellular density, proliferation rate, hypoxia, necrosis, and angiogenesis [18F]FDG uptake and the treatment response of lymphoma [. [18F]FDG PET promise predictive values for treatment response in patients with Hodgkin and follicular lymphoma, respectively. In a retrospective study of 30 patients, Sun et al. FDG PET of thirty-five NSCLC patients. They indicated that dynamic gray-level co-occurrence matrix (GLCM) features contain limited additional information compared to static radiomic features. However, the number of patients in the dataset was limited, and it is difficult to draw a general conclusion. This is noteworthy that the aforementioned studies [Ki to develop pre-therapy [18F]FDG PET/CT prediction models for response to chemotherapy in lymphoma patients.Alternatively, dynamic PET imaging, employed primarily in the research setting, can track PET radiopharmaceutical biodistribution in the body over time, offering dynamic analysis, including full kinetic modeling and potentially enhanced clinical tasks such as therapy response monitoring , 29. As n et al.  evaluate studies , 31 haveKi map was generated from DTP imaging using pre-treatment PET data. Next, radiomics features were extracted from the regions of interest (ROIs) segmented from the SUV PET image and Ki map. Afterward, ComBat harmonization is applied to each feature set to adjust for the batch impact caused by the multi-center dataset. Next, the response to treatment was evaluated according to the post-treatment PET scan. Finally, predictive models are developed to predict the treatment response of lymphoma (Hodgkin and non-Hodgkin) patients.Figure\u00a0We searched for lymphoma patients with PET/CT scans from January 2013 until March 2022. We investigated around 4000 patients\u2019 database records at two independent institutions, referred to as Centers 1 and 2. Medical records were carefully reviewed to identify which patients had pre- and post-treatment PET/CT scans, with the pre-treatment images acquired at DTP acquisition with a lesion in FOV of the delayed scan. The inclusion and exclusion criteria of patients are presented in Fig.\u00a0n\u2009=\u200975) vs. non-responding (n\u2009=\u200951). The clinical characteristics of the patients are reported in Table 18F]FDG PET/CT scans with detailed key acquisition parameters of the datasets presented in Table All patients benefited from a second PET/CT evaluation after the first line of chemotherapy, specifically the doxorubicin (adriamycin), bleomycin, vinblastine, and dacarbazine (ABVD) regimen in Hodgkin lymphoma, and the rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in non-Hodgkin lymphoma. Response to treatment was evaluated on a lesion basis according to Deauville criteria reported on the post-treatment PET scan . A totaling n\u2009=\u20095. The cliing n\u2009=\u20095. The cliKi map was defined as the slope of the Patlak equation from two time points, t1 (related to the routine static image data acquired 60-min post-injection) and t2 (the time of the delay scan) in the following Eq.\u00a0(CPET(t) and CP(t) denote radiopharmaceutical concentrations at time t in tissue and plasma, ROIs, respectively. We derived a subject-specific input function for each patient by scaling a population-based input function described by Vriens et al. [The image of the metabolic uptake rate was generated according to the DTP scan through an in-house MATLAB code , 34. In s et al.  to the pKi map.In most cases, the patient was taken off the bed following the whole-body (WB) PET prior to the delayed scan. As such, repositioning is a possible source of error for DTP evaluations. As a result, tumor-specific rigid registration between WB and delayed PET based on CT images was performed to maximize the accuracy of the Ki images and modified by erasing or adding voxels to ensure the entire tumor was included in the VOI. Finally, all VOIs were reviewed by two nuclear medicine specialists. Figure\u00a0Ki and SUV images.A threshold value of 30% of the maximum SUV was used to determine the VOI on the static images . Then, tKi maps were multiplied by 100 to obtain the same scale as the SUV image. Then, the SUV and Ki images were processed using 64 bins, with the minimum and maximum image intensity values set to 0 and 20. Additionally, the voxel size was resampled to 4\u2009\u00d7\u20094\u2009\u00d7\u20094 mm3. A total of 65 radiomics features, including the category of gray-level co-occurrence matrix , neighborhood gray-level different matrix , gray-level run length matrix , gray-level zone length matrix , shape (five features), histogram (four features), conventional (twelve features), and discretized (twelve features) indices, were extracted for each lesion in both SUV and Ki images. Full details about the features are presented in Table The LIFEx package (version 7.0.15) , which iHarmonization was performed for all PET parameters using the ComBat harmonization method  to elimiq values. A q value of less than 0.05 defined statistical significance.We calculated correlation coefficients between static and DTP features using Spearman\u2019s rank method to identify features that might provide additional information. Receiver operating characteristic (ROC) curve analysis was used to assess the predictive power of each radiomics feature before and after the ComBat harmonization. The AUC of DTP and static features and the AUC of features before and after the ComBat harmonization were compared using Delong\u2019s test. All the statistical analyses were performed in MedCalc . To assess the significance of the features, we also applied false discovery rate (FDR) Benjamini\u2013Hochberg (BH) correction to correct for multiple comparisons, reporting Ki map), (2) H_Static (harmonized features extracted from the SUV images), (3) H_ DTP\u2009+\u2009Static (combined harmonized features extracted from the DTP Ki map and the SUV images), (4) Non-H_ DTP (non-harmonized features extracted from the DTP Ki map), (5) Non-H_Static (non-harmonized harmonized features extracted from the SUV images), (6) Non-H_ DTP\u2009+\u2009Static (combined non-harmonized harmonized features extracted from the DTP Ki map and the SUV images).We developed various models using the DTP and static features before and after Combat harmonization. Our models were: (1) H_ DTP  approach  to the iThis study randomly divided the data into two groups: 80% for the model training and internal validation and 20% for the test. The test data were not used during model development. A subset of the training dataset was used to derive the models (80%), and the remainder (20%) was used for validation. We repeatedly trained a bootstrapped model with 1000 repetitions to find the optimal hyperparameters of models based on the random search method and AUC. Then, the optimal model was tested on the remaining 20% of the dataset (unseen during model training). This process was repeated 100 times to ensure the results were repeatable for different models. The mean ROC and the mean, standard deviation, and 95% confidence interval (CI) of AUC, accuracy (ACC), sensitivity (SEN), and specificity (SPE) were used to assess the predictive performance of the models. We used the Mann\u2013Whitney test to determine significant differences between the models.\u03c1), the features with low (\u03c1\u2009<\u20090.5), moderate (0.5\u2009<\u2009\u03c1\u2009<\u20090.7), and high (\u03c1\u2009>\u20090.7) correlation are reported in Table \u03c1\u2009<\u20090.7 contain additional information compared to static ones.Spearman\u2019s correlation matrix of static and DTP radiomics features is shown in Fig.\u00a0p value, and q value for each DTP and static feature before and after harmonization are reported in Additional file q value (<\u20090.05) using the Benjamini\u2013Hochberg procedure (BH), as shown in Additional file The AUC, The mRMR algorithm selected ten from 65 features for static and DTP models. From a total of 20 features composed of 10 top DTP and static features, the combined static\u2009+\u2009DTP model used ten selected features applying the mRMR algorithm. All of the selected features for each model are presented in Table p Values are shown in Fig.\u00a0p\u2009<\u20090.05).The heat map of AUC, accuracy (ACC), sensitivity (SEN), and specificity (SPE) for different models, including DTP, static, and DTP\u2009+\u2009static, before and after harmonization to predict treatment response, are shown in Fig.\u00a0i map, namely static and DTP features, respectively, and compared the predictive treatment response performance of DTP and static features. The present study investigated the potential information that DTP features may add to traditional features derived from the static PET images in 126 lesions of 45 lymphoma patients. Several studies have shown the significant potential of DTP imaging for generating parametric Ki images [Ki map by determining the slope between the two time points. Only a few studies have investigated the performance of dynamic features. Tixier et al. [max, SUVmean, and MTV) and heterogeneity quantification in NSCLC. They reported high correlations for all parameters between SUV and parametric images, which indicates that heterogeneity quantification on parametric images does not offer additional information compared to static SUV images. However, in another study, Noortman et al. [\u03c1\u2009<\u20090.5 in Table Accurate prediction of response will improve treatment strategies and therefore optimize therapeutic results. In this study, we developed radiomics models for predicting the response of lesions to chemotherapy using the XGBoost classifier based on the static and DTP PET features selected by the mRMR algorithm in lymphoma patients. To this end, we extracted radiomics features from the SUV image and DTP Ki images , 34, 44.r et al.  evaluaten et al.  found th\u03c1\u2009<\u20090.7 in Table Ki map using the DTP method to achieve a simple and clinically feasible approach for deriving dynamic features. Several studies evaluated conventional PET metrics  and showed the predicted value of treatment response in lymphoma patients [On the other hand, moderate correlation features provide a small amount of additional information . Among static features, GLRLM_RLNU  were found to be as most predictive features. Based on univariate results, there was no significant difference between the performance of most DTP and static radiomics features.Univariate analysis of our study showed that some radiomics features might be predictive. For harmonized DTP features, the highest AUCs were achieved for GLCM_Energy, GLCM_Entropy, and uniformity . Our study showed AUC\u2009=\u20090.88 for static features when taking advantage of the ComBat harmonization.Specifically, several studies developed radiomic models for lymphoma patients to provide a prediction response to therapy. In a retrospective study included 57 bulky malignant lymphoma patients, Bouall\u00e8gue et al.  presenteKi map. Our study sheds light on the possibility of treatment response prediction utilizing dynamic features by the DTP method. The results showed that DTP-feature yielded similar classification performance (AUC\u2009=\u20090.87) to static models (AUC\u2009=\u20090.88). Hence, since some DTP and static features had low and moderate correlations, they could serve as different markers. Previous studies reported improving performance by combining different markers, such as PET features and clinical data [Since performing dynamic acquisition has limitations in clinical practice, the predictive value of dynamic features was not considered previously. We used the clinically feasible DTP PET imaging to achieve the cal data , 49. Altcal data .There were some limitations in this study. Foremost, the study cohort is relatively small; we used datasets from only two centers where external validation was lacking from different centers. However, we used the bootstrap technique to evaluate our models to address the limited sample size; further clinical studies are needed to verify our results with more extensive clinical databases. Moreover, obtaining full-time input function information for the standard Patlak method requires either arterial blood sampling or a long scan covering early time points of the blood pool. We used a scaled population-based input function for Patlak analysis to overcome this challenge, although the lack of ground truth information might have influenced the results. Another limitation of this study was the lack of multiple segmentations to assess the effect of segmentation variability on the extracted features. Finally, clinical data  were not considered in the model as the focus was on imaging features.Ki maps and extract dynamic features, which can be applied in routine clinical practice. We demonstrated that the highest predictive performance of the XGBoost classifier with the mRMR algorithm was achieved when DTP and static features from FDG PET images were combined. We also demonstrated that ComBat harmonization significantly improved the performances of static, DTP, and combined static and DTP-based radiomics models toward significantly improved prediction of therapy response in lymphoma patients.Our results indicate the potential of combining dynamic and static features from FDG PET images to predict the treatment response in lymphoma patients. We used the dual-time-point framework to obtain the Additional file 1: Figure S1. Shows the univariate AUC, p-values, and q-values heat map of DTP and static features with and without Combat harmonizations. Figure S2. Shows univariate Delong test p-values and q-values comparing the performance of combat harmonization in static and DTP features with and without Combat harmonization. Differences with p and q < 0.05 are considered statistically significant and highlighted in purple.", "texts": ["Static and DTP radiomics features were extracted from baseline static PET images and DTP Ki parametric maps. Spearman\u2019s rank correlations were calculated between static and DTP features to identify features with potential additional information. We first employed univariate analysis to determine correlations between individual features, and subsequently utilized multivariate analysis to derive predictive models utilizing DTP and static radiomics features before and after ComBat harmonization. For multivariate modeling, we utilized both the minimum redundancy maximum relevance feature selection technique and the XGBoost classifier. To evaluate our model, we partitioned the patient datasets into training/validation and testing sets using an 80/20% split. Different metrics for classification including area under the curve (AUC), sensitivity (SEN), specificity (SPE), and accuracy (ACC) were reported in test sets.We analyzed 126 lesions from 45 lymphoma patients (responding \u03c1\u2009<\u20090.7); all the other 33 features showed high correlations (\u03c1\u2009\u2265\u20090.7). In univariate modeling, no significant difference between AUC of DTP and static features was observed. GLRLM_RLNU from static features demonstrated a strong correlation  with therapy response. The most predictive DTP features were GLCM_Energy, GLCM_Entropy, and Uniformity, each with AUC\u2009=\u20090.73, p value\u2009=\u20090.0001, and q value\u2009<\u20090.0005. In multivariate analysis, the mean ranges of AUCs increased following harmonization. Use of harmonization plus combining DTP and static features was shown to provide significantly improved predictions . All models depicted significant performance in terms of AUC, ACC, SEN, and SPE .Via Spearman\u2019s rank correlations, there was negligible to moderate correlation between 32 out of 65 DTP features and some static features (Our results demonstrate significant value in harmonization of radiomics features as well as combining DTP and static radiomics models for predicting response to chemotherapy in lymphoma patients.The online version contains supplementary material available at 10.1186/s13550-023-01022-0. In clinical oncology, medical imaging technologies have evolved from simple diagnostic tools to a source of valuable clinical information over the years , 2. In a18F]FDG or other PET radiopharmaceutical uptake patterns within a tumor have been characterized by identifying imaging features  reflecting biological characteristics, such as cellular density, proliferation rate, hypoxia, necrosis, and angiogenesis [18F]FDG uptake and the treatment response of lymphoma [. [18F]FDG PET promise predictive values for treatment response in patients with Hodgkin and follicular lymphoma, respectively. In a retrospective study of 30 patients, Sun et al. FDG PET of thirty-five NSCLC patients. They indicated that dynamic gray-level co-occurrence matrix (GLCM) features contain limited additional information compared to static radiomic features. However, the number of patients in the dataset was limited, and it is difficult to draw a general conclusion. This is noteworthy that the aforementioned studies [Ki to develop pre-therapy [18F]FDG PET/CT prediction models for response to chemotherapy in lymphoma patients.Alternatively, dynamic PET imaging, employed primarily in the research setting, can track PET radiopharmaceutical biodistribution in the body over time, offering dynamic analysis, including full kinetic modeling and potentially enhanced clinical tasks such as therapy response monitoring , 29. As n et al.  evaluate studies , 31 haveKi map was generated from DTP imaging using pre-treatment PET data. Next, radiomics features were extracted from the regions of interest (ROIs) segmented from the SUV PET image and Ki map. Afterward, ComBat harmonization is applied to each feature set to adjust for the batch impact caused by the multi-center dataset. Next, the response to treatment was evaluated according to the post-treatment PET scan. Finally, predictive models are developed to predict the treatment response of lymphoma (Hodgkin and non-Hodgkin) patients.Figure\u00a0We searched for lymphoma patients with PET/CT scans from January 2013 until March 2022. We investigated around 4000 patients\u2019 database records at two independent institutions, referred to as Centers 1 and 2. Medical records were carefully reviewed to identify which patients had pre- and post-treatment PET/CT scans, with the pre-treatment images acquired at DTP acquisition with a lesion in FOV of the delayed scan. The inclusion and exclusion criteria of patients are presented in Fig.\u00a0n\u2009=\u200975) vs. non-responding (n\u2009=\u200951). The clinical characteristics of the patients are reported in Table 18F]FDG PET/CT scans with detailed key acquisition parameters of the datasets presented in Table All patients benefited from a second PET/CT evaluation after the first line of chemotherapy, specifically the doxorubicin (adriamycin), bleomycin, vinblastine, and dacarbazine (ABVD) regimen in Hodgkin lymphoma, and the rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in non-Hodgkin lymphoma. Response to treatment was evaluated on a lesion basis according to Deauville criteria reported on the post-treatment PET scan . A totaling n\u2009=\u20095. The cliing n\u2009=\u20095. The cliKi map was defined as the slope of the Patlak equation from two time points, t1 (related to the routine static image data acquired 60-min post-injection) and t2 (the time of the delay scan) in the following Eq.\u00a0(CPET(t) and CP(t) denote radiopharmaceutical concentrations at time t in tissue and plasma, ROIs, respectively. We derived a subject-specific input function for each patient by scaling a population-based input function described by Vriens et al. [The image of the metabolic uptake rate was generated according to the DTP scan through an in-house MATLAB code , 34. In s et al.  to the pKi map.In most cases, the patient was taken off the bed following the whole-body (WB) PET prior to the delayed scan. As such, repositioning is a possible source of error for DTP evaluations. As a result, tumor-specific rigid registration between WB and delayed PET based on CT images was performed to maximize the accuracy of the Ki images and modified by erasing or adding voxels to ensure the entire tumor was included in the VOI. Finally, all VOIs were reviewed by two nuclear medicine specialists. Figure\u00a0Ki and SUV images.A threshold value of 30% of the maximum SUV was used to determine the VOI on the static images . Then, tKi maps were multiplied by 100 to obtain the same scale as the SUV image. Then, the SUV and Ki images were processed using 64 bins, with the minimum and maximum image intensity values set to 0 and 20. Additionally, the voxel size was resampled to 4\u2009\u00d7\u20094\u2009\u00d7\u20094 mm3. A total of 65 radiomics features, including the category of gray-level co-occurrence matrix , neighborhood gray-level different matrix , gray-level run length matrix , gray-level zone length matrix , shape (five features), histogram (four features), conventional (twelve features), and discretized (twelve features) indices, were extracted for each lesion in both SUV and Ki images. Full details about the features are presented in Table The LIFEx package (version 7.0.15) , which iHarmonization was performed for all PET parameters using the ComBat harmonization method  to elimiq values. A q value of less than 0.05 defined statistical significance.We calculated correlation coefficients between static and DTP features using Spearman\u2019s rank method to identify features that might provide additional information. Receiver operating characteristic (ROC) curve analysis was used to assess the predictive power of each radiomics feature before and after the ComBat harmonization. The AUC of DTP and static features and the AUC of features before and after the ComBat harmonization were compared using Delong\u2019s test. All the statistical analyses were performed in MedCalc . To assess the significance of the features, we also applied false discovery rate (FDR) Benjamini\u2013Hochberg (BH) correction to correct for multiple comparisons, reporting Ki map), (2) H_Static (harmonized features extracted from the SUV images), (3) H_ DTP\u2009+\u2009Static (combined harmonized features extracted from the DTP Ki map and the SUV images), (4) Non-H_ DTP (non-harmonized features extracted from the DTP Ki map), (5) Non-H_Static (non-harmonized harmonized features extracted from the SUV images), (6) Non-H_ DTP\u2009+\u2009Static (combined non-harmonized harmonized features extracted from the DTP Ki map and the SUV images).We developed various models using the DTP and static features before and after Combat harmonization. Our models were: (1) H_ DTP  approach  to the iThis study randomly divided the data into two groups: 80% for the model training and internal validation and 20% for the test. The test data were not used during model development. A subset of the training dataset was used to derive the models (80%), and the remainder (20%) was used for validation. We repeatedly trained a bootstrapped model with 1000 repetitions to find the optimal hyperparameters of models based on the random search method and AUC. Then, the optimal model was tested on the remaining 20% of the dataset (unseen during model training). This process was repeated 100 times to ensure the results were repeatable for different models. The mean ROC and the mean, standard deviation, and 95% confidence interval (CI) of AUC, accuracy (ACC), sensitivity (SEN), and specificity (SPE) were used to assess the predictive performance of the models. We used the Mann\u2013Whitney test to determine significant differences between the models.\u03c1), the features with low (\u03c1\u2009<\u20090.5), moderate (0.5\u2009<\u2009\u03c1\u2009<\u20090.7), and high (\u03c1\u2009>\u20090.7) correlation are reported in Table \u03c1\u2009<\u20090.7 contain additional information compared to static ones.Spearman\u2019s correlation matrix of static and DTP radiomics features is shown in Fig.\u00a0p value, and q value for each DTP and static feature before and after harmonization are reported in Additional file q value (<\u20090.05) using the Benjamini\u2013Hochberg procedure (BH), as shown in Additional file The AUC, The mRMR algorithm selected ten from 65 features for static and DTP models. From a total of 20 features composed of 10 top DTP and static features, the combined static\u2009+\u2009DTP model used ten selected features applying the mRMR algorithm. All of the selected features for each model are presented in Table p Values are shown in Fig.\u00a0p\u2009<\u20090.05).The heat map of AUC, accuracy (ACC), sensitivity (SEN), and specificity (SPE) for different models, including DTP, static, and DTP\u2009+\u2009static, before and after harmonization to predict treatment response, are shown in Fig.\u00a0i map, namely static and DTP features, respectively, and compared the predictive treatment response performance of DTP and static features. The present study investigated the potential information that DTP features may add to traditional features derived from the static PET images in 126 lesions of 45 lymphoma patients. Several studies have shown the significant potential of DTP imaging for generating parametric Ki images [Ki map by determining the slope between the two time points. Only a few studies have investigated the performance of dynamic features. Tixier et al. [max, SUVmean, and MTV) and heterogeneity quantification in NSCLC. They reported high correlations for all parameters between SUV and parametric images, which indicates that heterogeneity quantification on parametric images does not offer additional information compared to static SUV images. However, in another study, Noortman et al. [\u03c1\u2009<\u20090.5 in Table Accurate prediction of response will improve treatment strategies and therefore optimize therapeutic results. In this study, we developed radiomics models for predicting the response of lesions to chemotherapy using the XGBoost classifier based on the static and DTP PET features selected by the mRMR algorithm in lymphoma patients. To this end, we extracted radiomics features from the SUV image and DTP Ki images , 34, 44.r et al.  evaluaten et al.  found th\u03c1\u2009<\u20090.7 in Table Ki map using the DTP method to achieve a simple and clinically feasible approach for deriving dynamic features. Several studies evaluated conventional PET metrics  and showed the predicted value of treatment response in lymphoma patients [On the other hand, moderate correlation features provide a small amount of additional information . Among static features, GLRLM_RLNU  were found to be as most predictive features. Based on univariate results, there was no significant difference between the performance of most DTP and static radiomics features.Univariate analysis of our study showed that some radiomics features might be predictive. For harmonized DTP features, the highest AUCs were achieved for GLCM_Energy, GLCM_Entropy, and uniformity . Our study showed AUC\u2009=\u20090.88 for static features when taking advantage of the ComBat harmonization.Specifically, several studies developed radiomic models for lymphoma patients to provide a prediction response to therapy. In a retrospective study included 57 bulky malignant lymphoma patients, Bouall\u00e8gue et al.  presenteKi map. Our study sheds light on the possibility of treatment response prediction utilizing dynamic features by the DTP method. The results showed that DTP-feature yielded similar classification performance (AUC\u2009=\u20090.87) to static models (AUC\u2009=\u20090.88). Hence, since some DTP and static features had low and moderate correlations, they could serve as different markers. Previous studies reported improving performance by combining different markers, such as PET features and clinical data [Since performing dynamic acquisition has limitations in clinical practice, the predictive value of dynamic features was not considered previously. We used the clinically feasible DTP PET imaging to achieve the cal data , 49. Altcal data .There were some limitations in this study. Foremost, the study cohort is relatively small; we used datasets from only two centers where external validation was lacking from different centers. However, we used the bootstrap technique to evaluate our models to address the limited sample size; further clinical studies are needed to verify our results with more extensive clinical databases. Moreover, obtaining full-time input function information for the standard Patlak method requires either arterial blood sampling or a long scan covering early time points of the blood pool. We used a scaled population-based input function for Patlak analysis to overcome this challenge, although the lack of ground truth information might have influenced the results. Another limitation of this study was the lack of multiple segmentations to assess the effect of segmentation variability on the extracted features. Finally, clinical data  were not considered in the model as the focus was on imaging features.Ki maps and extract dynamic features, which can be applied in routine clinical practice. We demonstrated that the highest predictive performance of the XGBoost classifier with the mRMR algorithm was achieved when DTP and static features from FDG PET images were combined. We also demonstrated that ComBat harmonization significantly improved the performances of static, DTP, and combined static and DTP-based radiomics models toward significantly improved prediction of therapy response in lymphoma patients.Our results indicate the potential of combining dynamic and static features from FDG PET images to predict the treatment response in lymphoma patients. We used the dual-time-point framework to obtain the Additional file 1: Figure S1. Shows the univariate AUC, p-values, and q-values heat map of DTP and static features with and without Combat harmonizations. Figure S2. Shows univariate Delong test p-values and q-values comparing the performance of combat harmonization in static and DTP features with and without Combat harmonization. Differences with p and q < 0.05 are considered statistically significant and highlighted in purple."]}
{"representative": "Observance of preventive behaviors is one of the main ways to break the coronavirus disease 2019 (COVID-19) chain of transmission. Therefore, the present study was conducted to determine the knowledge and behaviors of prevention of COVID-19 and the related factors in the rural population of Rasht city.In this cross-sectional study, 344 people of the population referred to health centers in Rasht city were included through multi-stage cluster random sampling. The data were collected using a three-part researcher-made questionnaire including individual-social factors, knowledge about the prevention of COVID-19, and the preventive behaviors against COVID-19. Data analysis was performed using the Kolmogorov-Smirnov and Shapiro-Wilk tests, Spearman\u2019s correlation coefficient, and multiple logistic regression analysis, by SPSS software version 16 at a significance level\u2009<\u20090.05.s=0.001, P\u2009=\u20090.998). Awareness of COVID-19 was higher in university-educated individuals and women. Also, women, individuals who had access to the Internet, those trained by health centers, and those who were visited by health workers at home had more preventive behaviors.The mean total score of knowledge about COVID-19 was at a moderate level, and the preventive behaviors of COVID-19 were at a good level. There was no significant relationship between the scores of awareness and preventive behaviors of COVID-19 (rDespite the lack of connection between knowledge and preventive behaviors, the villagers living in the suburbs of Rasht had a moderate level of knowledge and a good level of preventive behaviors of COVID-19. Appropriate educational interventions should be carried out to increase the awareness and performance of the rural residents.The online version contains supplementary material available at 10.1186/s12912-023-01469-5. Coronavirus disease 2019 (COVID-19) is an infectious disease caused by the new beta coronavirus . The mosWith the spread of COVID-19 in Iran, extensive consequences were created for people\u2019s health and livelihood, and daily life activities were disrupted . The endPreventive health behaviors refer to any activity performed by a person who considers him/herself healthy to prevent disease . These mDespite preventive measures, most people are severely affected by COVID-19 disease . During It should be noted that preventive behaviors and public obedience to these behaviors are influenced by numerous physical, psychological, political, social, and cultural factors . Also, mAs one of the northern tourism regions of the country, Guilan province has been facing severe disease crises during the recent epidemics, so that it has received special attention from the country\u2019s health system as one of the most common areas of getting infected with COVID-19 disease with a high number of hospitalizations and deaths of patients . TherefoThis cross-sectional study was performed on people who referring to health centers in Rasht, Iran.The participants were the population who were referred to the of affiliated to Rasht city. A multi-stage cluster random method was used for sampling and the participants were entered to the study from November to December 2021. Inclusion criteria included interest in participating in the study, not being infected with COVID-19 disease at the time of sampling, having over 18 years of age, and having literacy. The incomplete questionnaires were excluded. As a rule of thumb, in regression analyses, for each independent variable (predictor), at least 20 subjects (10 or 15 subjects in some sources) should be selected . ConsideThe Rasht city have six rural health centers that provide health services to the people of 28 villages. For sampling, each health center was considered as clusters, and then according to the determined sample size and the geographical locations of the villages, 12 villages were randomly selected from these clusters and then a convenience sampling was done. Before sampling, the researcher explained about the research aims, the confidentiality of the information, and the voluntary participation in the study.The data collection tool was a three-part researcher-made questionnaire that included, individual-social factors, knowledge of prevention of COVID-19 disease, and assessing preventive behaviors against COVID-19. This questionnaire was designed from the official national protocols of the Ministry of Health of Iran and the guidelines of the American Centers for Disease Control and Prevention (CDC).The individual-social factors questionnaire had 16 questions included age, gender, marital status, number of family members, education level, occupation, family income status, underlying diseases, history of contracting COVID-19, loss of family members due to COVID-19, getting COVID-19 vaccine, access to health medical services in the village, accessibility to and using the Internet, receiving education about COVID-19 disease and ways to prevent it by the health center, the method of obtaining information related to COVID-19, and visiting health officers at home.The second part of the study instrument included 11 questions about knowledge of prevention of COVID-19 based on the national protocols. A correct answer was given a score of 1, and a wrong answer was given a score of 0. The minimum score of this questionnaire was 0, and the maximum was 11. A higher score indicated higher knowledge of prevention of COVID-19. Finally, the obtained scores were calculated based on 100 and divided into three levels: Low (0\u201360), moderate (61\u201380), and high (81\u2013100).The third part of the instrument were 43 questions about the preventive behaviors against COVID-19 retrieved from the protocols of Disease Control and Prevention (CDC). The scaling of the questionnaire has been organized based on a 4-point Likert scale . The total score of this questionnaire was 129, and the higher score indicated a high level of adherence to preventive behaviors against COVID-19. The obtained scores were calculated based on 100 and divided into three levels: Low (0\u201360), moderate (61\u201380), and high (81\u2013100).In order to assess the content validity, the questionnaire was given to ten professors in nursing and health in Guilan University of Medical Sciences and the requested changes were made. The mean content validity index (CVI) for the questionnaire of knowledge of prevention of COVID-19 was 0.92, and for the preventive behaviors against COVID-19 questionnaire was 0.97. To determine the content validity ratio (CVR), as values \u200b\u200bhigher than 0.62 were approved, therefore, the total questions were accepted.In order to evaluation of the reliability of the questionnaires, a pilot study was conducted on 20 people. The questionnaires were completed by the participants on two occasions, with an interval of two weeks. Cronbach\u2019s alpha coefficient and intraclass correlation coefficient (ICC) were used respectively to check the internal consistency and test-retest reliability of the questionnaires. The values of Cronbach\u2019s alpha coefficient and ICC for the preventive behaviors against COVID-19 questionnaire were reported as 0.934 and 0.998, respectively. For questionnaire of knowledge of prevention of COVID-19, the Cronbach\u2019s alpha coefficient 0.89 and ICC\u2009=\u20090.95 were obtained, which were at the acceptable levels.Data analysis was performed using SPSS for windows, version 16.0 . Continuous variables were presented as mean (standard deviation (SD)) and median (interquartile range (IQR)) and categorical variables as number (percentage). The Kolmogorov-Smirnov and Shapiro-Wilk tests were used to assess the normality of the data. Spearman\u2019s correlation coefficient was performed to examine the relationship between knowledge and behaviors of prevention of COVID-19. To examine factors associated with high knowledge and good behaviors of prevention of COVID-19, multiple linear regression analysis was performed. In this study the variables of knowledge and behaviors were considered as binary variables, then logistic regression model was used to analyze the data due to its binary nature. Odds ratio (OR) and 95% confidence interval (CI) were calculated. For all analyses, the level of significance was set at 0.05.The present study was conducted on 344 rural people. The participants\u2019 personal and social characteristics are presented in Table\u00a0Majority of the participants had a moderate level of knowledge about prevention of COVID-19 (47.4%). The mean score and the standard deviation of the knowledge was 73.4\u2009\u00b1\u200914.3. Median (Interquartile Range) was 72.7 (63.6\u201381.8) , and the lowest frequency was related to using traditional medicines (24.4%).Majority of the participants had a good level of preventive behaviors of COVID-19 (44.5%). The mean score and the standard deviation of the preventive behaviors in the participants was 74.8\u2009\u00b1\u200918.6. Median (Interquartile Range) was 77.9 (65.9\u201386) Table\u00a0.Assessing the questions of the preventive behaviors of COVID-19 showed that the highest frequency of the behaviors (77.6%) was related to avoid touching the inner part of the mask and tissue, and the lowest frequency was related to how to dilute sodium hypochlorite solution (29.1%).s=0.001, P\u2009=\u20090.998)  and the university-educated participants . In contrast, those whose family members had died due to COVID-19, had lower chance for high score of knowledge  , internet access , training by health workers , visiting by health workers at home , and having experience COVID-19 infection in the participants or their family  , which is consistent with the results of Keyvanlo et al.\u2019s study on women in Iran [Individuals who were trained by health workers and those who were visited by them at home had the good preventive behaviors. It could be because the rural population has more trust in the educations that provided by health workers, and they are the reliable source for people. Also, in the current study, level of knowledge of the participants about prevention of COVID-19 was higher in women and in the participants that had university education. Chen et al.\u2019s study on urban and rural residents in China showed that individuals with higher education had more knowledge . Moreove in Iran  and is n in Iran . The rea in Iran .One of the limitations of this study is using the self-reporting questionnaire. Also, the present study was conducted in the villages of the suburbs of Rasht city where the distance from the city was short, so the findings may have been influenced by this issue. We suggest that further studies be conducted in rural communities with different ages and cultures and in different geographical environments.The results of the current study indicated that the rural people had a moderate level of knowledge and a good level of preventive behaviors of COVID-19. A primary health care approach is essential for education of rural community in epidemic situations in Iran.Below is the link to the electronic supplementary material.Supplementary Material 1", "texts": ["Observance of preventive behaviors is one of the main ways to break the coronavirus disease 2019 (COVID-19) chain of transmission. Therefore, the present study was conducted to determine the knowledge and behaviors of prevention of COVID-19 and the related factors in the rural population of Rasht city.In this cross-sectional study, 344 people of the population referred to health centers in Rasht city were included through multi-stage cluster random sampling. The data were collected using a three-part researcher-made questionnaire including individual-social factors, knowledge about the prevention of COVID-19, and the preventive behaviors against COVID-19. Data analysis was performed using the Kolmogorov-Smirnov and Shapiro-Wilk tests, Spearman\u2019s correlation coefficient, and multiple logistic regression analysis, by SPSS software version 16 at a significance level\u2009<\u20090.05.s=0.001, P\u2009=\u20090.998). Awareness of COVID-19 was higher in university-educated individuals and women. Also, women, individuals who had access to the Internet, those trained by health centers, and those who were visited by health workers at home had more preventive behaviors.The mean total score of knowledge about COVID-19 was at a moderate level, and the preventive behaviors of COVID-19 were at a good level. There was no significant relationship between the scores of awareness and preventive behaviors of COVID-19 (rDespite the lack of connection between knowledge and preventive behaviors, the villagers living in the suburbs of Rasht had a moderate level of knowledge and a good level of preventive behaviors of COVID-19. Appropriate educational interventions should be carried out to increase the awareness and performance of the rural residents.The online version contains supplementary material available at 10.1186/s12912-023-01469-5. Coronavirus disease 2019 (COVID-19) is an infectious disease caused by the new beta coronavirus . The mosWith the spread of COVID-19 in Iran, extensive consequences were created for people\u2019s health and livelihood, and daily life activities were disrupted . The endPreventive health behaviors refer to any activity performed by a person who considers him/herself healthy to prevent disease . These mDespite preventive measures, most people are severely affected by COVID-19 disease . During It should be noted that preventive behaviors and public obedience to these behaviors are influenced by numerous physical, psychological, political, social, and cultural factors . Also, mAs one of the northern tourism regions of the country, Guilan province has been facing severe disease crises during the recent epidemics, so that it has received special attention from the country\u2019s health system as one of the most common areas of getting infected with COVID-19 disease with a high number of hospitalizations and deaths of patients . TherefoThis cross-sectional study was performed on people who referring to health centers in Rasht, Iran.The participants were the population who were referred to the of affiliated to Rasht city. A multi-stage cluster random method was used for sampling and the participants were entered to the study from November to December 2021. Inclusion criteria included interest in participating in the study, not being infected with COVID-19 disease at the time of sampling, having over 18 years of age, and having literacy. The incomplete questionnaires were excluded. As a rule of thumb, in regression analyses, for each independent variable (predictor), at least 20 subjects (10 or 15 subjects in some sources) should be selected . ConsideThe Rasht city have six rural health centers that provide health services to the people of 28 villages. For sampling, each health center was considered as clusters, and then according to the determined sample size and the geographical locations of the villages, 12 villages were randomly selected from these clusters and then a convenience sampling was done. Before sampling, the researcher explained about the research aims, the confidentiality of the information, and the voluntary participation in the study.The data collection tool was a three-part researcher-made questionnaire that included, individual-social factors, knowledge of prevention of COVID-19 disease, and assessing preventive behaviors against COVID-19. This questionnaire was designed from the official national protocols of the Ministry of Health of Iran and the guidelines of the American Centers for Disease Control and Prevention (CDC).The individual-social factors questionnaire had 16 questions included age, gender, marital status, number of family members, education level, occupation, family income status, underlying diseases, history of contracting COVID-19, loss of family members due to COVID-19, getting COVID-19 vaccine, access to health medical services in the village, accessibility to and using the Internet, receiving education about COVID-19 disease and ways to prevent it by the health center, the method of obtaining information related to COVID-19, and visiting health officers at home.The second part of the study instrument included 11 questions about knowledge of prevention of COVID-19 based on the national protocols. A correct answer was given a score of 1, and a wrong answer was given a score of 0. The minimum score of this questionnaire was 0, and the maximum was 11. A higher score indicated higher knowledge of prevention of COVID-19. Finally, the obtained scores were calculated based on 100 and divided into three levels: Low (0\u201360), moderate (61\u201380), and high (81\u2013100).The third part of the instrument were 43 questions about the preventive behaviors against COVID-19 retrieved from the protocols of Disease Control and Prevention (CDC). The scaling of the questionnaire has been organized based on a 4-point Likert scale . The total score of this questionnaire was 129, and the higher score indicated a high level of adherence to preventive behaviors against COVID-19. The obtained scores were calculated based on 100 and divided into three levels: Low (0\u201360), moderate (61\u201380), and high (81\u2013100).In order to assess the content validity, the questionnaire was given to ten professors in nursing and health in Guilan University of Medical Sciences and the requested changes were made. The mean content validity index (CVI) for the questionnaire of knowledge of prevention of COVID-19 was 0.92, and for the preventive behaviors against COVID-19 questionnaire was 0.97. To determine the content validity ratio (CVR), as values \u200b\u200bhigher than 0.62 were approved, therefore, the total questions were accepted.In order to evaluation of the reliability of the questionnaires, a pilot study was conducted on 20 people. The questionnaires were completed by the participants on two occasions, with an interval of two weeks. Cronbach\u2019s alpha coefficient and intraclass correlation coefficient (ICC) were used respectively to check the internal consistency and test-retest reliability of the questionnaires. The values of Cronbach\u2019s alpha coefficient and ICC for the preventive behaviors against COVID-19 questionnaire were reported as 0.934 and 0.998, respectively. For questionnaire of knowledge of prevention of COVID-19, the Cronbach\u2019s alpha coefficient 0.89 and ICC\u2009=\u20090.95 were obtained, which were at the acceptable levels.Data analysis was performed using SPSS for windows, version 16.0 . Continuous variables were presented as mean (standard deviation (SD)) and median (interquartile range (IQR)) and categorical variables as number (percentage). The Kolmogorov-Smirnov and Shapiro-Wilk tests were used to assess the normality of the data. Spearman\u2019s correlation coefficient was performed to examine the relationship between knowledge and behaviors of prevention of COVID-19. To examine factors associated with high knowledge and good behaviors of prevention of COVID-19, multiple linear regression analysis was performed. In this study the variables of knowledge and behaviors were considered as binary variables, then logistic regression model was used to analyze the data due to its binary nature. Odds ratio (OR) and 95% confidence interval (CI) were calculated. For all analyses, the level of significance was set at 0.05.The present study was conducted on 344 rural people. The participants\u2019 personal and social characteristics are presented in Table\u00a0Majority of the participants had a moderate level of knowledge about prevention of COVID-19 (47.4%). The mean score and the standard deviation of the knowledge was 73.4\u2009\u00b1\u200914.3. Median (Interquartile Range) was 72.7 (63.6\u201381.8) , and the lowest frequency was related to using traditional medicines (24.4%).Majority of the participants had a good level of preventive behaviors of COVID-19 (44.5%). The mean score and the standard deviation of the preventive behaviors in the participants was 74.8\u2009\u00b1\u200918.6. Median (Interquartile Range) was 77.9 (65.9\u201386) Table\u00a0.Assessing the questions of the preventive behaviors of COVID-19 showed that the highest frequency of the behaviors (77.6%) was related to avoid touching the inner part of the mask and tissue, and the lowest frequency was related to how to dilute sodium hypochlorite solution (29.1%).s=0.001, P\u2009=\u20090.998)  and the university-educated participants . In contrast, those whose family members had died due to COVID-19, had lower chance for high score of knowledge  , internet access , training by health workers , visiting by health workers at home , and having experience COVID-19 infection in the participants or their family  , which is consistent with the results of Keyvanlo et al.\u2019s study on women in Iran [Individuals who were trained by health workers and those who were visited by them at home had the good preventive behaviors. It could be because the rural population has more trust in the educations that provided by health workers, and they are the reliable source for people. Also, in the current study, level of knowledge of the participants about prevention of COVID-19 was higher in women and in the participants that had university education. Chen et al.\u2019s study on urban and rural residents in China showed that individuals with higher education had more knowledge . Moreove in Iran  and is n in Iran . The rea in Iran .One of the limitations of this study is using the self-reporting questionnaire. Also, the present study was conducted in the villages of the suburbs of Rasht city where the distance from the city was short, so the findings may have been influenced by this issue. We suggest that further studies be conducted in rural communities with different ages and cultures and in different geographical environments.The results of the current study indicated that the rural people had a moderate level of knowledge and a good level of preventive behaviors of COVID-19. A primary health care approach is essential for education of rural community in epidemic situations in Iran.Below is the link to the electronic supplementary material.Supplementary Material 1"]}