To develop a questionnaire to assess parents' experiences and satisfaction with care during very preterm birth.Questionnaire development.Parents whose babies had been cared for at five tertiary neonatal units in England.A total of 145 women who gave birth before 32 weeks of gestation, and 85 of their partners.A 30-item questionnaire was developed on the basis of qualitative interviews with parents of very preterm babies, a literature review and discussion with relevant experts. The questionnaire was posted to a second group of parents, and its reliability and validity were explored.α.The Preterm Birth Experience and Satisfaction Scale (P-BESS) was correlated with two global questions measuring satisfaction with care during the birth. Internal consistency was measured using Cronbach's Parents of 458 babies were invited to take part and 147 (32%) responded. Two women and 22 partners were excluded or ineligible, leaving 145 women and 85 partners. Factor analysis produced three clear dimensions: Staff professionalism and empathy, Information and explanations, and Confidence in staff. The total scale and three subscales showed high reliability. Strong positive correlations were found between the questionnaire scales and the two global questions, indicating convergent validity. For women whose partners were present at the birth, a fourth factor was identified ‘Partner Involvement’.The P-BESS appears to be a valid measure of satisfaction with care during very preterm birth. Preterm birth is the largest risk factor of perinatal mortality and morbidity and is associated with a reduced quality of life, negative psychosocial and emotional impact on the family, and high costs for health services. The highest mortality and morbidity affects the very preterm babies, born at <32 weeks of gestation.Understanding of the patients' experiences of healthcare services has improved considerably over recent decades, and patient satisfaction is now one of the most frequently reported health outcomes.11Satisfaction with maternity services, especially care during labour and birth, have become increasingly important to healthcare providers, administrators and policy makers.The aim of this study was to develop a multidimensional questionnaire to assess parents' satisfaction with care during the birth of their very preterm baby.The objective of this study was to develop a questionnaire to assess parents' experiences and satisfaction with care during the birth of their very preterm baby. The initial questionnaire was developed on the basis of interviews carried out with 39 parents of very preterm babies,An initial collection of 97 potential questions was generated to cover the above seven areas identified in the interviews. This collection included newly constructed questions, and questions from existing birth satisfaction questionnaires for term births. To minimise any response bias, questions were positively and negatively phrased. All of these questions were then screened by two expert reviewers; 30 were chosen, which best covered each of the seven domains identified above and avoided repetition, unclear wording, ambiguous meaning, or overlap with other constructs. Of these final 30 questions: one was from the Labour and Delivery Satisfaction Index;To examine the relationship between the P-BESS and overall satisfaction, a series of questions were included. These comprised two rating scales for overall satisfaction with care  scored on a five-point Likert scale; and three open-ended questions exploring parents' experiences and satisfaction with care .Questions were also included covering basic demographic , obstetric and neonatal details .Questionnaires were posted to parents with very preterm babies delivered at five tertiary care centres in England. Ethics approval was from the South East Coast—Brighton and Sussex NHS Research Ethics Committee. Parents were eligible for the study if they had a baby born before 32 weeks of gestation and were over 16 years of age. Parents were also eligible if only one member of the couple wanted to take part or if they were single.n = 19).Questionnaire packs were sent to parents of babies born in the previous 12 months by the neonatal consultant at each hospital. Information about the study was also available on the neonatal units in the form of posters . If parents did not respond they were sent a reminder letter and another copy of the questionnaire pack 2–4 weeks later. Bereaved parents were not sent a reminder letter. Parents were also given the option of completing and submitting the questionnaire online  was conducted with the women's P-BESS questionnaires to explore whether questions could be combined into subscales that represent different aspects of satisfaction with care during very preterm birth. Three of the 30 questions asked about partner's involvement in the birth so were only relevant to the women whose partners attended the birth. These questions were therefore excluded from the initial analysis, and 27 questions were entered into the factor analysis. The number of factors to be retained was determined using the scree plot and eigenvalues >1. Questions that loaded on a factor at >0.4 were considered significant and were retained. Questions that loaded on more than one factor ≥0.3 were removed and the analysis was re-run.To check whether questions and subscales in the women's P-BESS were applicable to partners, a confirmatory factor analysis was conducted. The fit of the women's questionnaire to the sample of partners was evaluated using the following model fit indices: chi-square test, the comparative fit index, and the root mean-square-error of approximation.spss 20  and amos 20 (SPSS Inc).There was a minimal amount of missing data (<5%) and missing points were imputed. Analyses were conducted with α coefficient, which is a measure of the interrelatedness between a set of questions designed to measure an overall construct ;Content validity describes whether an instrument adequately covers the domains to be evaluated. This should be evident through the systematic series of steps taken when designing the P-BESS. Convergent validity refers to the degree to which scores on an instrument correlate with scores on other instruments that measure a similar construct and was explored by examining the relationship between the total P-BESS score  with two questions assessing overall satisfaction with care during the birth. Reliability of the P-BESS was explored by looking at three indicators of internal consistency: (i) Cronbach's Between May 2012 and August 2012 458 couples/single parents were invited to take part in the study and 147 (32%) returned a completed questionnaire (147 women and 107 partners). Of these, 24 had to be excluded for various reasons: one woman and her partner whose baby was born in an ambulance, another woman who did not complete the questionnaire, and a further 21 partners who were not present at the birth and therefore could not complete the care questionnaire. The final sample therefore consisted of 145 women and 85 partners. Mean time between the birth and questionnaire completion for women was 264 days (SD 126) and for partners it was 266 days (SD 127). For six couples and one woman their baby died after birth. Demographic and obstetric characteristics are shown in TableInitial data screening was conducted to remove questions that were not performing well. First, the range of each question was examined using the entire sample (i.e. both parents) and questions were removed that did not use the full range of the scale. This resulted in three questions being removed . Second, the distributions of the questions were also examined through inspection of skewness values and histograms. Satisfaction scales are frequently skewed and this was expected in this sample of parents. All of the P-BESS questions were positively skewed, therefore it was not appropriate to remove any questions on this basis. Finally, questions were screened and removed either if they were too highly correlated with other questions >0.9 (zero questions) or did not significantly correlate with other questions (three questions). These latter questions correlated ≤0.3 with over 80% of questions .χ2 (210) = 2168.1, P < 0.001]. A further four questions had to be removed because of cross-loadings , low-loadings (‘The staff did not panic’) or because it was the only question loading on a factor (‘Each member of staff introduced themselves’).The remaining 21 questions were entered into the factor analysis. Statistical checks confirmed the sample was adequate for factor analysis (Kaiser–Meyer Olkin measure = 0.9) and correlations between questions were suitably large  indicating that women who had an emergency caesarean section were more satisfied with their care overall  than women who had a vaginal birth . Women were also more satisfied with staff professionalism and empathy  and confidence in staff  if they had an emergency caesarean section compared with a vaginal birth. Women who reported complications during pregnancy were more satisfied with their care overall  in comparison to those who did not report complications , U = −2.3, P < 0.05. Women were also more satisfied with information and explanation  and confidence in staff  if they reported complications during pregnancy. Time since birth and completion of the questionnaire was not associated with the total score, or any of the three subscales . Women's scores on the P-BESS and individual subscales did not differ significantly across the five centres.The majority of demographic variables were not associated with total scores on the rs = 0.22, P < 0.05). Partners' satisfaction with care at birth was not associated with time since birth, gestation, and whether the baby was alive or not. Partners' scores on the P-BESS did not differ significantly across the five centres.In partners, age was positively associated with overall satisfaction, with older partners reporting higher levels of satisfaction . The total scale and all three subscales showed high reliability and there was evidence for validity. A fourth subscale can be added to assess Partner Involvement for women whose partners' attended birth.Staff Professionalism and Empathy explained the largest proportion of variance. This is not surprising as support from staff is widely recognised as an important factor in determining birth satisfaction. Also, the stress and uncertainty surrounding very preterm birth are likely to increase the need for emotional support and reassurance from the staff.Information and Explanations and Confidence in Staff have been previously identified as important factors of satisfaction for during very preterm birth.α, and there were strong correlations between individual questions and scale scores.The factor analysis provided support of the P-BESS being multidimensional. The three identified domains are consistent with the literature, interviews with parents and input from healthcare professionals. The first subscale To our knowledge the P-BESS is the first questionnaire to assess satisfaction with care during very preterm birth. The P-BESS was comprehensively developed, can be completed quickly, administered by post or in the hospital, and is easy to score. The questions and domains were derived from parent interviews, discussion with healthcare professionals, and pilot tested with mothers. Also, the wording of many of the questions was based on interviews with women.Limitations include a relatively low response rate (approximately 30%), although this is a good response for studies of this kind. Also the sample size was relatively small for a factor analysis, which limits the validation process of the questionnaire. Moreover, the sample is not representative of all parents who have had a very preterm birth. For example, the sample mainly consisted of white, highly educated, married/co-habiting women. This is especially relevant because there is evidence to suggest that there is a higher incidence of very preterm birth in certain ethnic groupsshould be like and therefore just evaluate the status quo.Consistent with other studies of maternity satisfactionSome studies suggest that the timing of administering the questionnaire may have an influence on satisfaction. In the current study parents completed the questionnaire approximately 9 months after the birth. Studies suggest that parents' reports may be less positive 7–12 months after birth, compared with the first 6 months.The factor structure identified using the women's data did not fit with the partner's data well. There are a number of possible explanations for this. First, the questions were based primarily on previous interviews with parentsIn summary, this study reports the development and testing of the first questionnaire to assess satisfaction with care during very preterm birth. The P-BESS has three domains that are consistent with previous research and include important components of satisfaction. Depending on the needs of the researcher/clinician, questions can be summed to produce a total score, or factors can be looked at individually. A total score may be useful to compare across hospitals and differing practices, whereas individual aspects of the care environment can be evaluated using the separate subscales. The findings suggest good reliability and validity. Recommendations for future testing of the P-BESS include testing in a larger and broader population, and further testing of the construct validity.Project Group: Alexandra Sawyer, Heike Rabe, Jane Abbott, Gill Gyte, Lelia Duley, Susan Ayers; Principal Investigators at each site: Narendra Aladangady, Jon Dorling, Joe Fawke, Heike Rabe, Tim Scorrer; Research/Neonatal Nurses: Gillian Ager, Johnette Brown, Valerie Harper, Marie Hubbard, Liz Lance.The authors declare that there are no conflicts of interest.AS contributed to the protocol, co-ordinated the study, analysed the data and drafted the manuscript; HR contributed to the protocol and the revision and final approval of the manuscript. JA and GG (representatives from parent groups) contributed to the protocol and the revision and final approval of the manuscript. LD designed the study, contributed to the protocol and the revision and final approval of the manuscript and SA designed the study, contributed to the protocol, data analysis, revision and final approval of the manuscript.The study received approval from the NRES South East Coast—Brighton and Sussex NHS Research Ethics Committee. Reference: 12/LO/0145. Date of approval: 8 February 2012.National Institute of Health Research (Reference RP-PG-0609-10107): Improving quality of care and outcome at very preterm birth. This paper presents independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research funding scheme (RP-PG-0609-10107). The views expressed in this paper are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.


The aims of this study were to examine and compare the development of parenting cognitions and principles in mothers following preterm and term deliveries. Parenting cognitions about child development, including thinking that is restricted to single causes and single outcomes  and thinking that takes into account multiple perspectives (perspectivist thinking), have been shown to relate to child outcomes. Parenting principles about using routines (structure) or infant cues (attunement) to guide daily caregiving have been shown to relate to caregiving practices. We investigated the continuity and stability of parenting cognitions and principles in the days following birth to 5 months postpartum for mothers of infants born term and preterm. All parenting cognitions were stable across time. Categorical thinking increased at a group level across time in mothers of preterm, but not term, infants. Perspectivist thinking increased at a group level for first-time mothers (regardless of birth status) and tended to be lower in mothers of preterm infants. Structure at birth did not predict later structure (and so was unstable) in mothers of preterm, but not term, infants and neither group changed in mean level across time. Attunement was consistent across time in both groups of mothers. These results indicate that prematurity has multiple, diverse effects on parenting beliefs, which may in turn influence maternal behavior and child outcomes. However1.1One aim of developmental research is to understand how constructs develop across time , whereas others support or oppose both principles. Structure and attunement are related to parenting practices. For example, attunement is positively related to bed-sharing, breastfeeding, and holding in parents of infants under 18 months  to guide caregiving is crucial to ensure that such care is developmentally appropriate, as evidenced by the focus of many NICU-based interventions on new parents learning to use infants’ cues about hunger, distress, and sleepiness . NICU-baFlacking, Ewald, & Wallin, 2011Parenting cognitions and principles have generally been found to be stable in samples of parents of term infants of middle-SES European American background . However1.4This study aimed to chart maternal beliefs following preterm birth, and so child chronological age  was used to schedule visits. This decision was based on our plan to equate amounts of extrauterine experience across dyads at both time points. By contrast, using corrected age  to ensure equivalent biological maturity, mothers of preterm and term infants would necessarily differ in the quantity of postnatal and dyadic experience. Corrected age is problematic when studying social development and, in particular, the effects of preterm birth on early parent-infant interactions .When studying parenting following premature delivery, it is also imperative to distinguish between prematurity itself and the other factors associated with prematurity . For exaGutierrez & Sameroff, 19901.5This study examined how maternal complexity of thought and caregiving principles develop from the days following a premature or term delivery to a time when the parenting role is more established, 5 months later. Therefore, we assessed the continuity and stability of complexity of thought and caregiving principles in mothers of preterm vs. term infants. Our first aim was to examine whether the continuity and stability of maternal complexity of thought and caregiving principles differed by birth status when measured at birth and again 5 months later. We chose to schedule the follow-up data collection at 5 months to ensure parents had become established in the parenting role and infants were settled . We expeFew studies have systematically examined basic developmental properties of maternal complexity of thought and caregiving principles following premature deliveries. These assessments will increase our understanding of the development of maternal complexity of thought and caregiving principles in general and specifically in response to premature deliveries. Furthermore, this study examined whether prematurity had uniform or differentiated effects on complexity of thought and caregiving principles.22.1n = 41) or term (n = 64) infants’ development. Parents of infants born between 30 and 42 weeks gestational age were recruited. Mothers were divided into two groups by the birth status of their infant based on infant's gestational age; infants below 37 completed weeks of gestation were in the preterm sample , with the remaining 15 parents recruited through the Cardiff city registry office and other community links, such as the National Childbirth Trust . An additional 3 dyads were excluded due to a history of maternal depression or placement on the child-in-need register by local authorities to monitor the child due to concerns about the social environment of the child—for example, exposure to domestic abuse. Families were not approached if their infants had serious medical conditions beyond prematurity alone or congenital abnormalities that could affect growth and development, including requiring surgical intervention during hospitalization. Additionally, multiple births and parents under 16 years old were excluded. Suitable infants were identified as fitting inclusion and exclusion criteria through discussions with medical staff  responsible for their care.A total sample of 105 mothers completed questionnaires within the first month from delivery and 5 months later as part of a study about mothers’ and their preterm ; others had difficult life circumstances (27%), their infant had developed health problems (10%), or no longer wished to participate (10%).2.2All study procedures were reviewed by the Cardiff University School of Psychology's research ethics committee, the National Health Service's Research & Development, and Local Research Ethics Committee. Mothers consented to participate soon after delivering their baby at which time they completed the Baby Care Questionnaire BCQ;  and Conc2.32.3.1strongly disagree (1) to strongly agree (4). The BCQ contains 2 subscales—structure and attunement. Subscale scores were calculated by averaging across relevant items (17 items for structure and 13 items for attunement). Structure represents parent support of regularity and routines in their infant's daily life. For example, It is important to introduce a sleeping schedule as early as possible. Structure showed adequate internal consistency at birth  and 5 months . Attunement represents parent trust and attention to their infant's cues and support of close physical contact. For example, Responding quickly to a crying baby leads to less crying in the long run. Three items for the attunement subscale had poor distributions and did not relate with overall attunement or other items making up the attunement subscale and so were not used in calculating the average attunement score. The resulting 10-item attunement scale showed adequate internal consistency at birth  and 5 months .The BCQ  asks par2.3.2strongly disagree (0) to strongly agree (3). The CODQ measures parent cognitions about child development, in particular parent ability to think complexly about children. The CODQ contains two subscales – categorical and perspectivist – and a summary scale of complexity. For each subscale an average score is calculated. At the categorical level, parent cognitions are restricted to single determinants and single outcomes. For example, Parents must keep to their standards and rules no matter what their child is like. Three items for the categorical subscale had poor distributions and did not relate with the subscale overall or with the other items making up the subscale and so were not used to calculate the categorical subscale score. The remaining 7-item categorical subscale showed adequate internal consistency at birth  and 5 months . At the perspectivist level, child development is viewed from multiple perspectives, allowing parents to understand that multiple factors can interact and change over time to result in different outcomes. For example, Parents change in response to their children. Cognizing at the perspectivist level allows parents to view and evaluate a large range of developmental possibilities. Three items for the perspectivist subscale had poor distributions and did not relate with the subscale overall or with the other items making up the subscale, so were not used to calculate the perspectivist subscale score. The remaining 7-item perspectivist subscale showed adequate internal consistency at birth  and 5 months . Previous studies have found similar internal consistency coefficients when using the CODQ /2. Therefore, complexity represents the balance between categorical and perspectivist thinking and also ranges from 0 to 3. To ensure the BCQ and CODQ used equivalent scales, after calculating complexity, all subscales of the CODQ were transformed to range from 1 to 4 . Therefore, a complexity score of 4 means that parents strongly agree with items related to the perspectivist subscale and strongly disagree with items related to the categorical subscale. Conversely, a complexity score of 1 means that parents strongly disagree with items related to the perspectivist subscale and strongly agree with items related to the categorical subscale.Correlations among maternal structure, attunement, categorical, perspectivist, and complexity for birth and 5-month variables by birth status indicated that structure was not related to any of the cognitions, but attunement was positively related to perspectivist scores and to a smaller extent complexity scores. However, the correlation coefficients did not indicate singularity for any of these measures (shared variance = 0–28%) and so were treated independently.2.4Mothers completed a demographic questionnaire after delivery that collected information about demographic variables, previous pregnancies, and the current or most recent pregnancy and delivery. In addition, researchers accessed the medical records of the infant after discharge and created records of the infants’ health during their hospitalization.33.1Prior to data analysis, distributions of categorical thinking, perspectivist thinking, complexity of thought, structure, and attunement at both time points were examined for normality, homogeneity of variance, and influential outliers. All variables met assumptions for parametric tests.The first aim was to assess the continuity and stability of complexity of thought and caregiving principles in mothers of preterm and term infants. Therefore, the effects of child age (birth vs. 5 months) and birth status (preterm vs. term) were tested using repeated-measures Analysis of Variance (RM-ANOVA). Child age (birth vs. 5 months) was treated as a within-subjects variable and birth status (preterm vs. term) was treated as a between-subjects variable. In addition, stability estimates were reported across ages for maternal complexity of thought and caregiving principles by birth status using correlation. The next aim was to identify what variables may account for any developmental changes observed in complexity of thought and caregiving principles. Multiple regression analyses were used to examine predictors of differential stability across groups, and RM-ANCOVAs were used to examine predictors of discontinuity. The predictors of change in mean level or discontinuity were examined using RM-ANCOVAs. First, the main effects of infant age (birth vs. 5 months) and birth status, and the effect of the infant age × birth status interaction on cognitions or principles at 5 months were examined. Then, covariates were included to examine their effect on the significance of the main effect of age and the infant age × birth status interaction. Reducing either the main effect of age or the infant age × birth status interaction to nonsignificance would indicate that the covariates, at least in part, accounted for the discontinuity of maternal cognitions or principles. For the predictors of differential stability of cognitions or principles, we used a similar process with multiple regressions. In the first step, cognitions or principles at birth (centered), birth status (preterm vs. term), and the interaction between cognitions or principles at birth and birth status were included as predictors, and cognitions or principles at 5 months was the outcome variable. Covariates were then included in the second step to examine whether their inclusion attenuated the cognitions or principles at birth or interaction term to nonsignificance. Potential health and demographic covariates were selected by examining zero-order correlations with 5-month scores for cognitions or principles of interest.3.2F = 12.28, p < 0.001, ηp2 = 0.107, no main effect of birth status, F = 0.00, p = 0.960, ηp2 = 0.002, and a significant interaction between infant age and birth status, F = 4.34, p = 0.040, ηp2 = 0.040. Simple effects analyses examined the interaction between infant age and birth status on categorical thinking. A main effect of age was found for mothers of preterm, F = 15.36, p < 0.001, ηp2 = 0.277, but not term infants, F = 1.17, p = 0.283, ηp2 = 0.018. Categorical thinking was continuous in mothers of term, but not preterm, infants. Mothers of preterm and term infants did not differ in their categorical thinking at birth, F = 1.03, p = 0.312, ηp2 = 0.010, or 5 months later, F = 1.61, p = 0.208, ηp2 = 0.015. Mothers of preterm infants increased their categorical thinking with age, whereas mothers of term infants did not change with age.For categorical thinking, there was a main effect of age, F, p, and ηp2 values for step 1—infant age, birth status, and infant age × birth status interaction – and step 2—adding covariates – in predicting categorical thinking. In step 1, there was a significant main effect of age, F = 11.83, p < 0.001, ηp2 = 0.114, but no main effect of birth status, F = 0.32, p = 0.573, ηp2 = 0.003, and a trend level interaction between infant age and birth status, F = 3.77, p = 0.055, ηp2 = 0.039, on categorical scores. Adding covariates attenuated the main effect of age to nonsignificance, F = 0.15, p = 0.705, ηp2 = 0.002 (a 0.112 reduction in the ηp2), but only very slightly reduced the interaction between age and birth status, F = 3.46, p = 0.066, ηp2 = 0.037 (a 0.002 reduction in the ηp2). None of the covariates independently predicted discontinuity in categorical thinking. The RM-ANCOVAs for mothers of preterm and term infants individually showed that the main effect of age was nonsignificant for both groups  = 0.97, p = 0.332, ηp2 = 0.027; term: F = 0.41, p = 0.523, ηp2 = 0.008). The only difference in the RM-ANCOVAs was that Apgar scores at 5 min independently predicted categorical scores at 5 months for mothers of preterm infants, F = 4.43, p = 0.042, ηp2 = 0.112 , but not term infants, F = 0.01, p = 0.932, ηp2 = 0.000. Together, Apgar at 5 min, number of siblings, and mother living with a partner accounted for discontinuity in categorical thinking for both groups, but only Apgar scores at 5 min independently predicted categorical scores at 5 months in mothers of preterm infants.We examined possible explanations for the discontinuity of categorical scores in mothers of preterm infants. Apgar scores at 5 min, number of siblings, and whether the mother was living with a partner (no vs. yes) were included as covariates because these variables were related to categorical thinking at 5 months. Apgar scores at 5 min were not recorded in medical records for 11 infants (2 preterm and 9 term), and therefore these dyads were excluded, resulting in a final sample of 94 (39 preterm and 55 term). F = 12.53, p < 0.001, ηp2 = 0.108, a main effect of birth status at a trend level, F = 3.70, p = 0.057, ηp2 = 0.035, but no significant interaction between infant age and birth status, F = 0.48, p = 0.491, ηp2 = 0.005. Mean differences demonstrated that perspectivist thinking was lower, on average, at birth  and in mothers of preterm infants . When controlling for previous children and previous preterm birth, the main effect of age remained, F = 17.39, p < 0.001, ηp2 = 0.149, as did the main effect of birth status, F = 4.00, p = 0.048, ηp2 = 0.039. However, there was also a significant interaction between age and birth order, F = 5.11, p = 0.026, ηp2 = 0.049. Simple effects analyses indicated that the main effect of age was only significant for mothers of firstborns, F = 20.39, p < 0.001, ηp2 = 0.251, and not mothers of laterborns, F = 0.02, p = 0.894, ηp2 = 0.000. Mothers of firstborns increased in their perspectivist thinking from birth to 5 months  but perspectivist thinking did not change for mothers of laterborns  for both groups of mothers. In addition, mothers of preterm infants were lower on perspectivist thinking than mothers of term infants.For perspectivist thinking, there was a main effect of age, F, p, and ηp2 values for step 1—infant age, birth status, and infant age × birth status interaction – and step 2—adding covariates – in predicting perspectivist thinking. In step 1, there were main effects of age, F = 16.20, p < 0.001, ηp2 = 0.210, but no significant main effect of birth status, F = 2.19, p = 0.144, ηp2 = 0.035, or interaction between infant age and birth status, F = 0.84, p = 0.364, ηp2 = 0.014, on perspectivist scores. Adding covariates attenuated the main effects of age, F = 2.83, p = 0.098, ηp2 = 0.046 (a 0.164 reduction in the ηp2) to nonsignificance. None of the covariates independently predicted perspectivist thinking. Therefore, highest maternal qualification, attending antenatal classes, and breastfeeding together accounted for the discontinuity of perspectivist thinking.We examined potential explanations for the discontinuity of perspectivist scores in the mothers of firstborn preterm and term infants. Mother's highest educational qualification, attending antenatal classes (no vs. yes), and breastfeeding at birth (no vs. yes) were included as covariates because these variables were related to perspectivist thinking at 5 months. Only first-time mothers were included, and one dyad was excluded due to missing data for breastfeeding at birth, resulting in a final sample of 63 (22 preterm and 41 term). F = 0.01, p = 0.937, ηp2 = 0.000, or birth status, F = 1.82, p = 0.181, ηp2 = 0.017, or interaction between infant age and birth status, F = 0.93, p = 0.336, ηp2 = 0.009, for complexity of thought. Complexity of thought did not differ by infant age or birth status and was therefore continuous for mothers of preterm and term infants.Finally, there were no main effects of age, Z-tests indicated that the stability coefficients did not differ between mothers of preterm and term infants for categorical scores , perspectivist scores , or complexity scores .Stability was found for all three CODQ variables in mothers of term and preterm infants . Z-tests3.3F = 0.12, p = 0.729, ηp2 = 0.001, or birth status, F = 3.28, p = 0.073, ηp2 = 0.031, or interaction between infant age and birth status, F = 0.18, p = 0.671, ηp2 = 0.002. When controlling for previous children and previous preterm birth, there was a significant main effect of birth status, F = 3.96, p = 0.050, ηp2 = 0.038, but still no main effect of age, F = 0.83, p = 0.364, ηp2 = 0.008, or interaction between infant age and birth status, F = 0.07, p = 0.789, ηp2 = 0.001. The main effect of birth status reflected that mothers of preterm infants  supported structure more, on average, than mothers of term infants .For structure, there was no main effect of age, F = 0.89, p = 0.349, ηp2 = 0.009, or birth status, F = 2.06, p = 0.154, ηp2 = 0.020, or interaction between infant age and birth status, F = 0.04, p = 0.838, ηp2 = 0.000. Therefore, structure and attunement did not differ across age or birth status and were continuous for mothers of preterm and term infants. However, when controlling for previous experience of caregiving, mothers of preterm infants were higher on structure than mothers of term infants.For attunement, there was no main effect of age, Z-tests indicated that the stability of structure was significantly lower for mothers of preterm infants than term infants . Stability was also found for attunement for mothers of preterm and term infants .Stability was found for structure for mothers of term infants but not mothers of preterm infants . Z-tests infants . The staR2 = 0.34, F = 16.72, p < 0.001. Neither structure at birth nor birth status predicted structure at 5 months, but the interaction between structure and birth status predicted structure at 5 months. This result reflects the earlier finding that structure was only stable in mothers of term infants and not in mothers of preterm infants. Step 2 did not account for significantly more variance than step 1, ΔR2 = 0.00, F = 0.53, p = 0.467. Adding family income as a covariate attenuated the interaction term to nonsignificance  but only just (a 0.02 absolute reduction in the β). Family income did not independently predict instability in structure. Therefore, family income accounts for some of the differential stability in structure between mothers of preterm and term infants but only to a limited degree.We examined potential explanations for the differential stability of structure in mothers of preterm and term infants. Family income was included as a covariate because this variable was related to structure at 5 months. Three dyads were missing data on family income and therefore were excluded from these analyses resulting in a final sample of 102 (40 preterm and 62 term). 4The first aim of the study was to examine developmental trajectories of maternal complexity of thought and caregiving principles following preterm and term deliveries in the first 5 months of their infant's life. We found prematurity had a differentiated effect on complexity of thought and caregiving principles, with different levels of complexity of thought and caregiving principles affected differently. The second aim was to examine demographic and medical variables that might explain changes in complexity of thought and caregiving principles. Below we first discuss the findings related to complexity of thought and then caregiving principles.4.1Categorical thinking was continuous for mothers of term, but not preterm, infants. Mothers of preterm infants showed increasing levels of categorical thinking from the delivery of their infant to 5 months later (and therefore an increase in less complex thinking). In combination, Apgar scores at 5 min, number of siblings, and whether mothers were living with a partner accounted for the discontinuity of categorical thinking in mothers of preterm infants. The only independent predictor of categorical thinking was 5-min Apgar scores for mothers of preterm, but not term, infants. For mothers of preterm infants, higher 5-min Apgar scores were related to higher categorical thinking scores at 5 months but not at birth. However, it must be noted that 5-min Apgar scores of the preterm infants reflected the low-risk nature of the sample, as scores ranged from 7 to 10 (but around 86% scored 9 or 10). Therefore, this finding needs to be further examined in a higher risk sample with a wider range of Apgar scores. For both groups of mothers of firstborn infants, perspectivist thinking increased over time and overall levels were lower in all mothers of preterm infants regardless of parity. The discontinuity of perspectivist thinking for first-time mothers was accounted for by a combination of highest maternal qualification, having attended antenatal classes, and breastfeeding at birth . Finally, complexity of thought was continuous for both birth status groups. Stability was found at equal levels for all three complexity of thought variables across birth status groups.Despite equal levels of complexity of thought, prematurity had an impact on categorical and perspectivist thinking. Categorical thinking increased in mothers of preterm infants from birth to 5 months but remained continuous in mothers of term infants. In addition, mothers of preterm infants were less able (at trend levels) to demonstrate perspectivist thinking. However, complexity of thought did not differ by the birth status or age of the infant. Despite being able to think as complexly about child development as mothers of term infants, mothers of preterm infants appear to increasingly rely on lower levels of thinking. This result could have important implications because lower levels of thinking have been shown to relate to more rigid and authoritarian parenting , and mor4.2Structure and attunement were both stable and continuous in mothers of term infants. In contrast, structure was continuous but unstable, and attunement was continuous and stable, for mothers of preterm infants. Therefore, only the caregiving principle of structure appeared to be affected by premature birth. In mothers of preterm infants, structure at birth did not predict structure 5 months later. Therefore, mothers of preterm infants appeared to change their support of structure over the first 5 months but not in a uniform way . The differential stability of structure by birth status was reduced to nonsignificance by controlling for family income. However, the reduction of the interaction term of structure at birth × birth status was small, and family income did not add to the variance accounted for in the regression model. Therefore, this result should be considered with caution. Perhaps characteristics of the infant  would provide a better explanation of the differential stability of structure than demographic or medical factors. For example, it could be that the lower stability of structure following preterm delivery reflects that these mothers are more willing to be flexible in structure and base that principle on their infant's willingness or ability to fit into a schedule. Alternatively, as preterm birth is often unexpected and accompanied by periods of hospitalization, mothers’ support of structure at birth may not be a representation of their true principles but instead reflect the structure of the hospital and medical staff. As such, mothers of preterm infants may only develop their own principles about structure on leaving the hospital and becoming fully responsible for their infants’ daily care. Both of these hypotheses fit with findings that, when controlling for previous experience with children, structure appeared to be higher in mothers of preterm, as compared to term, infants. Future work should examine such hypotheses.Attunement, in comparison, did not appear to be affected by premature deliveries as attunement showed stability and continuity for mothers of preterm and term infants. Many interventions implemented following premature deliveries or during NICU stays focus on teaching parents to respond to the cues and unique characteristics of their infant  increased in their perspectivist thinking as their infants grew older, while mothers of laterborns showed consistency across time. In addition, given that different cognitions about child development and caregiving principles showed different trajectories these results further highlight that parenting is multidimensional . FurtherEunice Kennedy Shriver National Institute of Child Health and Human Development; and Shobha Cherian, Department of Child Health, University Hospital of Wales.Alice Winstanley, Department of Psychology, University of Cambridge; Rebecca G. Sperotto and Merideth Gattis, School of Psychology, Cardiff University; Diane L. Putnick and Marc H. Bornstein,


The incidence of both gestational diabetes mellitus and preeclampsia is on the rise; however, these pregnancy complications may not be systematically reported. This study aimed to examine differences in reporting of preeclampsia and gestational diabetes between hospital records and birth certificate data, and to determine if such differences vary by maternal socioeconomic status indicators.We obtained over 70,000 birth records from 2001 to 2006 from the perinatal research database of the Memorial Care system, a network of four hospitals in Los Angeles and Orange Counties, California. Memorial birth records were matched to corresponding state birth certificate records and analyzed to determine differential rates of reporting of preeclampsia and diabetes. Additionally, the influence of maternal socioeconomic factors on the reported incidence of such adverse pregnancy outcomes was analyzed. Socioeconomic factors of interest included maternal education levels, race, and type of health insurance (private or public).It was found that the birth certificate data significantly underreported the incidence of both preeclampsia (1.38 % vs. 3.13 %) and diabetes (1.97 % vs. 5.56 %) when compared to Memorial data. For both outcomes of interest, the degree of underreporting was significantly higher among women with lower education levels, among Hispanic women compared to Non-Hispanic White women, and among women with public health insurance.The Memorial Care database is a more reliable source of information than birth certificate data for analyzing the incidence of preeclampsia and diabetes among women in Los Angeles and Orange Counties, especially for subpopulations of lower socioeconomic status. Adverse pregnancy outcomes such as gestational diabetes mellitus and preeclampsia have important consequences on the growth, development, and health of children and mothers alike. Gestational diabetes mellitus is defined as carbohydrate intolerance with onset or recognition during pregnancy . The truDespite the fact that the incidence of both gestational diabetes and preeclampsia is on the rise, there is concern that these and other pregnancy complications are not systematically recognized, diagnosed, or reported. In fact, numerous studies have found significant inconsistency between medical information that is reported on birth certificates and other medical records such as hospital-discharge records. A recent study found that in Washington State, most pregnancy complications in general, and gestational diabetes in particular, are substantially underreported on birth certificates compared to hospital-discharge data . AnotherIn addition to the question of systematic underreporting of adverse pregnancy outcomes, there is considerable interest in determining if this underreporting varies according to socioeconomic status. The socioeconomic gradient in preeclampsia is well established, with more recent data suggesting that there is a significant negative association between socioeconomic status and preeclampsia. Studies have found such an association using maternal education level , census Studies that have investigated the association between socioeconomic status and gestational diabetes, however, have generated conflicting results that vary according to the socioeconomic indicators used. Numerous studies have found low socioeconomic status to be associated with a higher risk of gestational diabetes using maternal employment status , neighboIt has not yet been determined if the discrepancies in the results of these studies may be accounted for by differential reporting rates among populations of varying socioeconomic levels, a feature that may vary across study settings. Additionally, the reliability of California’s birth certificate registry compared to available medical records has yet to be determined. Thus, this paper examines the possibility of underreporting of adverse pregnancy outcomes in patients in Los Angeles County and Orange County, California, using data from both birth certificates and hospital birth records, with a specific focus on possible differential rates of underreporting according to socioeconomic status.Birth record data from the period of 2001 to 2006 were obtained from the Memorial Care System, a network of four hospitals that maintains a perinatal database for research purposes . RecordsBirth records from the Memorial Care System were matched to birth certificate records using fuzzy matching logic through the SAS “COMPGED” function, which measures the “generalized edit distance” that summarizes the degree of difference between two text strings – i.e. the number of deletions, insertions, or replacements in the characters of a word required to arrive at the observed word . MemoriaWe summarized the basic socio-demographic variables in both the Memorial and the birth certificate data and in the matched and the unmatched groups for each dataset. T-tests for continuous variables and chi-square tests for categorical variables were used for the comparisons of the rates of preeclampsia and diabetes, and the socio-demographic variables between the matched and the unmatched groups within each specific dataset.Further, for the matched birth records, we compared the influence of socioeconomic factors ) on the reported incidences of preeclampsia or diabetes during pregnancy. The Memorial data contained only the lumped variable of diabetes  during pregnancy. Prior to 2006, gestational and pre-existing diabetes were grouped into a single variable in the birth certificate data. After 2006, gestational diabetes and pre-existing diabetes were reported separately. Therefore, we analyzed diabetes over 2001–2005 and conducted sensitivity analysis using 2001–2006 data as well.Given the potential for underreporting of adverse pregnancy outcomes on birth certificates, we did not specifically examine the agreement of the two databases using parameters such as sensitivity, specificity or Kappas. Rather, we focused on determining if underreporting of diabetes and preeclampsia would disproportionately affect low socioeconomic status groups when level of maternal education, type of health insurance, and race were used as socioeconomic indicators. In order to explore this, we calculated the ratio of incidences of diabetes  and preeclampsia using birth certificate data compared to Memorial data. A permutation based statistical test was used to check whether the incidence of preeclampsia and diabetes was significantly underreported on birth certificate data when compared to Memorial data. The socioeconomic variables used for the comparison were those based on birth certificate data, which have been shown to provide reliable information on these variables –34. MateAfter removing multiple births (e.g. twins and triplicates) and the records with missing matching variables, we obtained 66,352 and 71,512 records in the Memorial and the birth certificate data, respectively. After excluding these records, a total of 62,200 records  were matched and subsequently used in our analysis (Table N = 4162 to 62200), the majority of t-tests and chi-square tests showed statistically significant results when comparing the matched and the unmatched group in each dataset. Nevertheless, the pattern of difference in the unmatched vs. matched group was consistent in the Memorial data and the birth certificate data.Summary statistics showed some differences in the characteristics of the study population between the Memorial and the birth certificate data and between the matched and unmatched records in each specific dataset Table . The majp < 0.01). The underreporting in birth certificate data was also observed in subcategories of the socioeconomic variables we examined.It was found that the birth certificate data significantly underreported the incidence of preeclampsia when compared to the Memorial data (1.38 % vs. 3.13 %) Table  (p < 0.0p = 0.02) (Table p = 0.01).Of the mothers with known education level, the birth certificate data showed that the incidence of preeclampsia was significantly higher among mothers with education levels of college or higher compared with mothers with education levels of high school or lower  Table . No diffp < 0.01). The same held true for the birth certificate data. In addition, Hispanic women had significantly lower rates of preeclampsia than Non-Hispanic White women (p = 0.03) in the birth certificate data, while Asian women had significantly lower rates of preeclampsia than Non-Hispanic White women (p = 0.01) in the Memorial data.Both the Memorial and birth certificate data indicated the highest rate of preeclampsia in Black women  among the four major race/ethnicity categories. Within the Memorial data, Asian and Hispanic women had significantly lower rates of preeclampsia than Black women (p = 0.01). No significant difference for the degree of underreporting in birth certificate data was observed between the other race/ethnicity groups.Compared to the Memorial data, the birth certificate data showed a significantly higher degree of underreporting of preeclampsia in Hispanic women compared to Non-Hispanic White women (p = 0.05). A different but insignificant pattern was observed in the birth certificate data. Compared to the Memorial data, the birth certificate data showed a significantly higher degree of underreporting of preeclampsia within the public insurance group compared to the private insurance group (p = 0.02).The Memorial data indicated a marginally significantly lower rate of preeclampsia in women with private insurance compared to those with public insurance . Memorial data indicated that the incidence rate of diabetes during pregnancy was higher among women with lower socioeconomic status, but the pattern was insignificant in the birth certificate data. Sensitivity analysis showed similar results based on data in the 2001–2006 period (results not shown).Similar to preeclampsia, the birth certificate data significantly underreported the incidence of diabetes when compared to the Memorial data (1.97 % vs. 5.56 %) Table  (p < 0.0p < 0.01) (Table p = 0.01).No significant patterns were observed in birth certificate data. However, of the women whose educational level was known, the Memorial data indicated that the incidence of diabetes was significantly higher among women with levels of education of high school or lower compared to college or higher  Table . The birp < 0.01) between all the race/ethnicity group pairs except Asian and Hispanics. Furthermore, the degree of underreporting using birth certificate data compared to Memorial data was significantly higher among Hispanic women compared to Non-Hispanic White women (p < 0.01).The birth certificate data found that the incidence of diabetes was highest among Asian women (2.65 %) and lowest among Non-Hispanic White women (1.54 %), while the Memorial data indicated the highest incidence rate among women of race/ethnicities classified as “other” (8.19 %) and Asian (7.41 %) and lowest among Non-Hispanic White women (3.63 %). For both the Memorial and birth certificate data, the difference in incidence rates was significant (p < 0.01). The birth certificate data showed a similar but insignificant pattern. The degree of underreporting of diabetes using birth certificate data compared to Memorial data was significantly higher among women with public insurance compared to those with private insurance (p = 0.05).Memorial data found that the incidence of diabetes was significantly higher among women with public health insurance compared to women with private health insurance  and likely moderate to serious problems in misspelling of the names, respectively. We found differences in the matched and unmatched groups in the rates of preeclampsia and diabetes and in socio-demographic parameters. But since the patterns of difference in the matched and the unmatched groups was consistent between the Memorial data and the birth certificate data, we do not expect it to change our main conclusion of the underreporting problem in the birth certificate data.Since the Memorial data did not differentiate between gestational diabetes and diabetes when reporting pregnancy outcomes, it was not possible to investigate gestational diabetes specifically in this study. However, because the birth certificate data began reporting gestational diabetes separately starting in 2006, we were able to perform two separate analyses on diabetes using 2001–2005 and 2001–2006 as periods of interest. Both periods showed the same patterns of underreporting of diabetes, and we thus suspect that our findings on total diabetes likely hold for gestational diabetes as well. It has been estimated that approximately 90 % of pregnancies that are complicated by diabetes mellitus represent women with gestational diabetes mellitus . In the These results are consistent with previous studies, particularly those that determined that birth certificates are not reliable sources of information regarding preeclampsia, gestational diabetes, and other maternal complications and characteristics, particularly when compared to hospital discharge records –11. ThusThe socioeconomic differences seen in the underreporting of preeclampsia and gestational diabetes as specific outcomes of interest is a unique observation that has not been studied in southern California. However, similar results have been found by studies that have analyzed related, though not identical, variables elsewhere in the United States. Most notably, a study on the sensitivity of birth certificate reports of birth defects in Atlanta found that Non-Hispanic Black maternal race/ethnicity and maternal education levels lower than high school were independently associated with a lower probability of a birth defect diagnosis being reported on a birth certificate . The autFurther research must be performed to elucidate an explanation for the poor reliability of this particular set of birth certificate data for pregnancy complications, as well as the observed socioeconomic gradient in underreporting of such outcomes. Nevertheless, these findings have important implications for future public health research. Studies that rely solely on birth certificate data to draw conclusions regarding pregnancy complications should be aware of a potential bias towards underestimating the incidence of these conditions, particularly in low socioeconomic groups. This is critical for the descriptive study of socioeconomic disparities in pregnancy complications, and might contribute to explain why discrepant results were reported in the past –28, besiin-utero exposure on various long-term health effects . Standardizing data collection and reporting procedures across hospitals would help minimize the discrepancies seen between birth certificate data and hospital databases such as the Memorial database. Because diabetes and preeclampsia are conditions that are oftentimes diagnosed prior to delivery and not at the hospital of delivery, there is also a need to improve the integration of prior medical records from other sources with hospital and birth certificate records. What is more, the fact that the birth certificate data underreported both preeclampsia and diabetes and did so to a higher degree among groups of lower socioeconomic status suggests that it would be most effective to focus standardization efforts on these particular conditions and among these identified groups, including Black and Hispanic women, women with lower levels of education, and women with public insurance. Finally, the most disadvantaged women may not have access to health care; thus improving health care access for low-income and minority people may also improve the reporting of pregnancy complications.Furthermore, these findings indicate that there is a considerable need to improve the quality of birth certificate data in California, as far as pregnancy complications are concerned. There is a possibility that the quality of birth certificate has improved since 2006, the last year of this analysis. It would be beneficial to assess the quality of current birth certificate data in order to identify areas that still require improvement. However, historical birth certificate data are still of high importance for research studies that examine the impact of In summary, this comparison of two birth record databases found that the Memorial database is a more reliable source of information than birth certificate data for analyzing the incidence of preeclampsia and gestational diabetes among women in Los Angeles County. This is especially true for subpopulations of lower socioeconomic status. Efforts to improve the available sources of data for the study of adverse pregnancy outcomes should thus focus on improving the reliability of birth certificate data, particularly for women of lower socioeconomic status.The study has been approved by the Institutional Review Board of the University of California, Irvine and by the Institutional Review Board of MemorialCare Health System and Long Beach Memorial Medical Center. However, informed consent from study participants was not required because the nature of the study was analysis of existing data, which posed minimal risk to the subjects. In addition, it was not practically feasible to contact all the subjects.Not applicable.The birth record data used in this study will not be shared because they contained confidential information including the name of the mother and the date of birth of both the mother and the infant.


The health effects of suspended particulate matter (PM) may depend on its chemical composition. Associations between maternal exposure to chemical constituents of PM and newborn’s size have been little examined.We aimed to investigate the associations of exposure to elemental constituents of PM with term low birth weight , mean birth weight, and head circumference, relying on standardized fine-scale exposure assessment and with extensive control for potential confounders.2.5 and PM10) at maternal home addresses during pregnancy were estimated using land-use regression models. Adjusted associations between each birth measurement and concentrations of eight elements  were calculated using random-effects regression on pooled data.We pooled data from eight European cohorts comprising 34,923 singleton births in 1994–2008. Annual average concentrations of elemental constituents of PM ≤ 2.5 and ≤ 10 μm . Increased nickel and zinc in PM2.5 concentrations were also associated with an increased risk of LBW. Head circumference was reduced at higher exposure to all elements except potassium. All associations with sulfur were most robust to adjustment for PM2.5 mass concentration. All results were similar for PM10.A 200-ng/mSulfur, reflecting secondary combustion particles in this study, may adversely affect LBW and head circumference, independently of particle mass.http://dx.doi.org/10.1289/ehp.1409546Pedersen M, Gehring U, Beelen R, Wang M, Giorgis-Allemand L, Andersen AM, Basagaña X, Bernard C, Cirach M, Forastiere F, de Hoogh K, Gražulevičienė R, Gruzieva O, Hoek G, Jedynska A, Klümper C, Kooter IM, Krämer U, Kukkonen J, Porta D, Postma DS, Raaschou-Nielsen O, van Rossem L, Sunyer J, Sørensen M, Tsai MY, Vrijkotte TG, Wilhelm M, Nieuwenhuijsen MJ, Pershagen G, Brunekreef B, Kogevinas M, Slama R. 2016. Elemental constituents of particulate matter and newborn’s size in eight European cohorts. Environ Health Perspect 124:141–150;  Low birth weight  is a predictor of infant morbidity and mortality. The evidence for associations between exposure to airborne particulate matter (PM) and LBW is growing . Recent PM is a complex mixture of solid matter and liquid droplets made up of a number of components, including elemental carbon, metals, organic chemicals, acids, and soil material, which vary in composition by place and time . The hea2.5) with LBW and/or birth weight were investigated in four large study populations from the United States (2.5 and PM with an aerodynamic diameter ≤ 10 μm (PM10) mass concentration  models have also been developed for eight s Europe  where bis Europe , providis Europe .In the present study, we estimated the impact of exposures to these eight PM constituents on term LBW, birth weight, and birth head circumference in a large European study population with standardized fine-scale exposure assessment and extensive control for potential confounders.Study population. We pooled data from eight European mother–child cohorts conducted in areas where exposure to elemental composition of PM was assessed as part of the TRANSPHORM  project  was defined as the interval between the start of the last menstrual period and delivery when possible (53% of births) . UltrasoAir pollution exposure assessment. We estimated exposure to PM elements in two size fractions (PM2.5 and PM10), using standardized methods developed within the ESCAPE and TRANSPHORM projects and relying on a LUR approach  within each study area. Sites were selected to represent spatial variation of air pollution in the residential areas of the participants. Measurements were performed during 2008–2011 . PM2.5 and PM10 filters were weighed before and after each measurement centrally at IRAS (Institute for Risk Assessment Sciences), Utrecht University, and were then sent to Cooper Environmental Services  to detect elements. All filters were analyzed for elemental composition using X-ray Fluorescence (XRF)  . The thrce (XRF) . The selce (XRF) .2.5, and PM10 were estimated at the maternal home addresses during pregnancy with area-specific LUR models , sex, parity , maternal height (centimeters), prepregnancy weight (broken stick model with a knot at 60 kg), mean number of cigarettes smoked during second trimester of gestation (cigarettes/day), maternal age (years), maternal education , and season of conception .Crude and adjusted models were examined. Adjustment variables were selected Each exposure variable was entered separately as a continuous variable in regression models.2.5, PM10), other elements or traffic density on nearest street (vehicles per day), separately. We used variance inflation factors (VIF) diagnostics to assess collinearity problems, low values of VIF (< 5) being considered to be indicative that collinearity concerns are minor. We report two-pollutant models for pairs of pollutants selected from the results of the one-pollutant models.Because of the correlations between some elemental constituents and particle mass, associations with elements may be biased and instead reflect relationships with particle mass. We therefore also performed analyses with two-pollutant models for each element adjusted for particle mass (PMa) restriction to women who did not change home address during pregnancy ; b) restriction to areas where exposure models had the highest predictive value ; c) restriction to women from cohorts other than the DNBC, which accounted for half of the overall study population; d) restriction to women who participated with one pregnancy only ; e) further adjustment for maternal nationality (native vs. other) and self-reported maternal exposure to secondhand smoke (SHS) during pregnancy ; f) analyses stratified on maternal nationality (defined as above), maternal age , sex, parity , maternal active smoking , maternal education , or season of conception, to examine potential effect measure modification; and finally, we repeated analyses on term LBW and birth weight for the smaller study population with information on birth head circumference.Sensitivity analyses included p > 0.05) between these factors and the outcomes assessed in the present study population.We tested for the effect of meteorological factors  on the birth outcomes of interest to decide whether adjustment was warranted; both linear and restricted cubic spline coding were considered. In sensitivity analyses, LBW and birth weight models were additionally adjusted for atmospheric pressure averaged over the full pregnancy, and head circumference was adjusted for average temperature (both fitted as a restricted cubic spline); we did not adjust for other meteorological factors because there were no evidence of associations  correction to correct for multiple testing  and chosAir pollution exposure was estimated for 34,923 mother–child pairs from eight cohorts in seven European countries . DemograExposure levels. Air pollution pregnancy exposure levels were on average 17.0 μg/m3 for PM2.5 and 26.9 μg/m3 for PM10 . The highest concentrations and exposure gradients of Cu and Fe were observed for the Italian cohort , others  mainly in the coarse fraction (PM10–PM2.5). The eight selected elements represented 6% and 7% of the total mass of PM2.5 and PM10, respectively. Exposure to particle mass and particle constituents did not differ by maternal nationality (results not shown).for PM10 . The ratn cohort . The SweParticle mass concentrations were correlated with some elemental concentrations as shown in The correlation coefficients between PM constituents varied from –0.001 to 0.97 . The correlations between elemental and particle mass concentrations varied between cohorts, and the within-area correlations between mass and elements were smaller in each individual cohort than in the pooled sample .PM constituents and term low birth weight. Significant ORs of term LBW were estimated for particle mass, S, and Ni in the PM2.5 fraction, and for particle mass and S in PM10  was stronger than the association with PM2.5 mass concentration . This was also the case for S in PM10  and Ni in PM2.5 . All VIFs were < 5 in the presented two-pollutant models. in PM10 . In two-2.5 and PM10 fractions . The ORs changed very little after exclusion of the DNBC, of women who moved, and of women who participated with more than one pregnancy, and after additional adjustment for nationality and SHS. Excluding areas in which the LUR exposure models had the lowest R2 attenuated associations, but OR remained elevated and significant for PM10. Stratified analyses showed that the adjusted ORs for S (PM2.5 and PM10) were somewhat higher for women born elsewhere than in the country of the cohort, women who smoked, and women who gave birth for the first time, but none of these differences were significant. No significant differences (interaction p > 0.05) were seen by maternal education level, sex, maternal age, and season of conception. There was no consistent pattern of PM components having greater effects in boys or in girls .Sensitivity analyses supported an association between S and LBW both for the PM2.5 and PM10 after further adjustment for atmospheric pressure .The ORs remained elevated and significant for S in both PM2.5 and PM10 . Opposite to the findings for LBW, the change in birth weight associated with the between-center exposures to particle mass, Ni, S, and Zn in both PM2.5 and PM10 were statistically significantly larger than the change associated with within-center exposures . There was no consistent pattern of the PM components having greater effects on birth weight or head circumference in boys than in girls .ntration . FurtherPM constituents and birth head circumference. The correlation coefficient between birth weight and head circumference is 0.60 in full-term infants , which means that indeed birth weight does not explain all the variation in head circumference. All pollutants but K (PM2.5 and PM10) were associated with significant reductions in birth head circumference (mference .2.5 and PM10) and Ni (PM2.5 only) were stronger than the associations with PM mass concentration. Also the association for Ni PM2.5 remained statistically significant in two-pollutant models after adjustment for S PM2.5. The association with Ni in PM10 was null after adjustment for S in PM10, whereas associations with S in PM10 and PM2.5 persisted after adjustment for Ni.In two-pollutant models for head circumference, the associations with S (in both PM2.5 do not change much after adjustment for traffic density (results not shown). Further adjustment for temperature and atmospheric pressure averaged during the full pregnancy did not change any of the associations . The effects of between- and within-center exposures on head circumference were significantly different for some but not all pollutants . For this outcome, the overall effects reflected more the effects of the within-center variations in exposures. The within-center effects on head circumference were significantly larger than the between-center effects for particle mass, Ni, S, and V in PM2.5 as well as S and V in PM10. For Zn, the between-center effects were stronger than the within-center effects. For K in PM2.5, there was a stronger positive association within-center.For all outcomes, the effects estimates of both S and Zn in PM2.5, the OR for term LBW in the full study population was 1.36 , which was slightly smaller than the OR of 1.43  in the restricted study population with head circumference information. There was no difference in the associations of S in PM2.5 with birth weight .The study population for head circumference analyses was smaller than the population for birth weight analyses ; in term2.5 lost their statistical significance for term LBW , but the effects of mass (PM2.5) and S (both PM fractions) remained significant. For birth weight, only the effect estimates of S in PM2.5 remained statistically significant, whereas for head circumference, all effects were significant, except for K in PM10 (results not shown).After we applied an FDR correction, the effects of Ni and Zn in PM2.5 and PM10 with newborn’s size in eight cohorts from seven European countries. S in both PM2.5 and PM10 and Ni in PM2.5 were associated with an increased risk of term LBW, reduced birth weight, and smaller birth head circumference. The association between S and LBW was robust to adjustment for co-pollutants including particle mass as well as FDR correction. The particle mass effect estimates were reduced and became statistically nonsignificant after adjustment for S.We examined associations of eight elemental constituents in PM2.5 has been associated with increased ORs for LBW in two studies from the United States   and –2 g , respectively, compared to –40 g  in our study). The differences between ours and previous studies may be explained by differences in study design and the fact that the previous U.S. studies on elemental composition of PM relied on exposure estimates based on data from the nearest regulatory air quality monitor, which do capture temporal trends (which our model did not capture), but less efficiently capture within-city exposure contrasts, and may have resulted in misclassification of exposure. Moreover, we were able to estimate both the effects of between-center and within-center variations in air pollution concentrations. The nonsignificant differences of the effects of between center and within center exposure on LBW may be seen as indicating that both regional and local pollution contribute to the associations with LBW. Previous studies were not always able to consider known and suspected risk factors of LBW such as maternal stature, smoking, parity, atmospheric pressure, humidity, and season of conception. This is not a purely theoretical concern; as an illustration, in our study most elemental components were statistically significantly associated with birth weight in crude models and in models without adjustment for parity, but not in the most comprehensive models we used, which included parity.S in PMd States . The est7, 1.13)  and 1.027, 1.13) . PreviouOur comparison of between-center and within-center effects indicates that between-center differences in exposure contribute more to the reductions in mean birth weight than within-center exposure contrasts. These findings could reflect the smaller exposure contrasts within each center compared with the larger exposure contrasts derived from the pooled population  and perhOur findings on head circumference indicate that the within-center variation of these elements is important and that the reductions in head circumference were driven by within-center exposure contrasts for most pollutants except for K and Zn .2.5 components and birth head circumference. In our study all the elemental components except K were significantly associated with smaller head circumference.Head circumference has been associated with cognitive ability  and chil2.5  emissions [2.5 and PM10 varied less within centers than between centers  the study areas, and the spatial variation of S within areas was explained mostly by various traffic, land use, and residential density variables . In Euromissions . In our  centers , and the2) and SO2 has been associated with risk of LBW (2 is explained partly by the association with PM (which is correlated with NO2) and LBW. Mechanisms for the association between air pollution exposure and pregnancy outcomes are not well understood, but several hypotheses exist , and good precision of measurements in all eight cohorts; the harmonized and detailed information on potential confounders; and the large population spread over a large geographical area. Detailed information on individual characteristics  was collected prospectively in a manner that enabled us to reduce potential biases through adjustment.2 have been shown to be stable over time in a study, which covered the Italian study area included in the present study . The adjusted OR for LBW associated with PM2.5 was 1.21  in the present study, which is similar to the OR of 1.18  from our previous study  because nonworking women differed from the working group of women  in terms of nationality, age, parity, smoking habits, and other risk factors (results not shown), and it was unknown whether these nonworking women spend more time at home than the working women. Incomplete information on residential mobility may introduce exposure misclassification. Most women (84%), however, did not move residence during pregnancy, and analyses restricted to women who did not change home address during pregnancy gave very similar results to those reported for the full study population.Our exposure assessment was limited to home address(es), and exposures elsewhere such as at work or during commuting were not estimated, because detailed information on time–activity patterns or personal measures were not available. We had information on work status during pregnancy for five out of the eight cohorts, but we did not perform sensitivity analyses restricted to nonworking women  in order to separate effects on fetal growth from effects on inadequate time to growth (preterm delivery). In our study we chose not to study small-for-gestational-age because different country-specific reference growth curves were applied in the different centers. Moreover, it is not straightforward to apply a common growth curve for quantification of the deviation in birth weight relative to the expected weight at birth to a study population enrolled from a large heterogeneous study area because fetal growth not only differs by gestational age but also by, for example, nationality, sex, parity, and maternal stature. For this reason we choose to focus on simple measures of newborn’s size at birth.Finally, we acknowledge that because low birth weight is associated with altered growth patterns in childhood, it would be relevant to consider effects of air pollution on child weight and height at other time points in and after pregnancy, as done in a few studies .a priori selected elements in both the PM2.5 and PM10 fraction, so there might be issues related to multiple comparisons, and the correlation between different elements and the extent to which they can act as surrogate for the exposures causing the effect. Associations with S remained after applying an FDR, though other associations weakened. One should keep in mind that correction for multiple testing in situations like the present one, with several (related) end points and correlations between exposures, is complex  PDFClick here for additional data file.


Visual inspection with Acetic Acid (VIA) and Visual Inspection with Lugol’s Iodine (VILI) are increasingly recommended in various cervical cancer screening protocols in low-resource settings. Although VIA is more widely used, VILI has been advocated as an easier and more specific screening test. VILI has not been well-validated as a stand-alone screening test, compared to VIA or validated for use in HIV-infected women. We carried out a randomized clinical trial to compare the diagnostic accuracy of VIA and VILI among HIV-infected women. Women attending the Family AIDS Care and Education Services (FACES) clinic in western Kenya were enrolled and randomized to undergo either VIA or VILI with colposcopy. Lesions suspicious for cervical intraepithelial neoplasia 2 or greater (CIN2+) were biopsied. Between October 2011 and June 2012, 654 were randomized to undergo VIA or VILI. The test positivity rates were 26.2% for VIA and 30.6% for VILI (p = 0.22). The rate of detection of CIN2+ was 7.7% in the VIA arm and 11.5% in the VILI arm (p = 0.10). There was no significant difference in the diagnostic performance of VIA and VILI for the detection of CIN2+. Sensitivity and specificity were 84.0% and 78.6%, respectively, for VIA and 84.2% and 76.4% for VILI. The positive and negative predictive values were 24.7% and 98.3% for VIA, and 31.7% and 97.4% for VILI. Among women with CD4+ count < 350, VILI had a significantly decreased specificity (66.2%) compared to VIA in the same group  and compared to VILI performed among women with CD4+ count ≥ 350 . VIA and VILI had similar diagnostic accuracy and rates of CIN2+ detection among HIV-infected women.NCT02237326ClinicalTrials.gov  Cervical cancer is the fourth most common cancer in women, with an estimated 527,624 cases diagnosed globally in 2012. High ratCytology-based screening strategies have been effective in reducing rates of cervical cancer in the United States and other developed countries but are infeasible in low-resource settings. The need for skilled personnel, laboratory equipment, and the transport and storing of cervical specimens are key barriers for many rural areas in countries facing considerable infrastructure and cost constraints. Referrals for follow-up and treatment can also lead to high rates of attrition, highlighting the importance of same day results. To avoidVisual inspection with acetic acid (VIA) and visual inspection with Lugol’s iodine (VILI) are low-cost screening technologies that have been implemented as alternatives to cytology-based programs, with VIA being the most widely studied and used. By highlighting precancerous lesions in a way that can be seen by the naked eye, visual inspection techniques can be administered in clinics by trained non-physician clinicians with immediate results. Although there are some drawbacks to the use of visual screening methods, including the tests’ subjectivity which leads to varying accuracy in different settings, numerous studies have found VIA to have acceptable sensitivity and specificity and costWith a number of developing countries introducing visual inspection screening methods on a national or pilot basis, it is crWe conducted a randomized clinical trial to compare the sensitivity, specificity, and positive and negative predictive values of VIA and VILI for the detection of cervical intraepithelial neoplasia 2 or worse (CIN2+). Recruitment and enrollment took place between October 2011 and June 2012. Women attending the Family AIDS Care and Education Services (FACES) clinics in Kisumu, Kenya were consecutively recruited to participate if they were eligible for cervical cancer screening per the Kenya Ministry of Health guidelines  and had not been previously diagnosed with or treated for CIN2+. After providing informed consent, women were randomized to undergo either VIA or VILI in a 1:1 allocation. Randomization was done at a central site by the data manager in blocks of five through the computer program Stata 11 . Randomization assignment was given after enrollment by the study coordinator. Regardless of randomization arm, women underwent a pelvic inspection with naked visual inspection of the cervix to confirm eligibility. Women with evidence of cervicitis (mucopurulent discharge or friability) were considered ineligible and offered treatment per the clinic’s guidelines for syndromic management of cervicitis.Cervical exams were performed by three study staff  who had been trained and certified to perform VIA, VILI and colposcopy and had each performed over 1200 VIAs, 400 VILIs and 400 colposcopies prior to study initiation. Women in the VIA arm had a naked eye evaluation of the cervix to identify landmarks, followed by application of 5% acetic acid and a re-evaluation of the squamocolumnar junction (SCJ) after one to two minutes, using a standard exam lamp as a light source. VIA was considered satisfactory if the entire SCJ was identified. The appearance of well-defined or raised dense aceto-white lesions near the SCJ indicated a positive result. This was immediately followed by a colposcopy, performed by a second provider, blinded to the VIA results. Colposcopic exam included naked eye inspection, re-application of acetic acid, green filter and Lugol’s iodine. A cotton swab was used to assist clinicians in visualizing the endocervical canal if the entire SCJ was not seen. Colposcopy results were reported as normal, inflammation, probably CIN1, probably CIN2+, or suspicious for cancer. Biopsies were based on colposcopic findings, regardless of VIA or VILI result. Women underwent colposcopically-directed biopsy for any unsatisfactory colposcopies or for lesions suspicious for CIN2+ or cancer. No biopsies were performed in women with normal colposcopic exams; these women were determined to have “no disease” based on colposcopic findings. Due to interference in the colposcopic exam from the staining properties of Lugol’s iodine, women in the VILI arm underwent colposcopic exam first, followed by VILI performed by a second, blinded provider. A VILI was considered to be positive if the clinician identified any mustard-yellow non-iodine staining flat or raised lesions near the SCJ. After VILI was completed, the clinician performing the colposcopy returned to the room in order to evaluate the cervix with Lugol’s iodine and make the final decision to perform a biopsy.Biopsy specimens were stored in 10% buffered formalin at room temperature in the FACES lab for up to week, then sent in batches to the Department of Human Pathology anatomical pathology lab at the University of Nairobi for interpretation. Specimens were read separately by two histopathologists who were blinded to the results of the VIA. Results were reported using the WHO classification system for gynecologic tumors. For specBaseline demographic and clinical data was collected at the time of the visit, including age, marital status, education, reproductive history, last menstrual period, contraceptive use and current HAART regimen. The three-drug HAART regimens were those available at FACES, per the Kenya Ministry of Health Guidelines. First-line nucleoside reverse transcriptase inhibitor- (NRTI) based regimens contained zidovudine, stavudine or tenofivir plus lamivudine plus a non-nucleoside reverse transcriptase inhibitor (NNRTI), either nevirapine or efavirenz. Second-line NRTI-based regimens included lopinavir/ritonavir, plus lamivudine or abacavir and an NRTI. Additional clinical variables were obtained from the paper file (reviewed at the time of the study visit) and the electronic medical record. These included verification of current and previous HAART regimens, WHO Stage, all documented CD4+ counts, time since HIV-diagnosis and duration of enrollment into HIV-care. CD4+ nadir has been shown to be an effective indicator of immune status as it relates to risk for cervical disease, so we defined the lowest CD4+ count measured while in care as a proxy for CD4+ nadir.For test performance calculations for the primary outcome, VIA or VILI results were categorized as negative or positive. Colposcopy results were categorized as presence or absence of biopsy-confirmed CIN2+. We based our sample size calculations on the CIN2+ prevalence of 7% in this clinic. AssumingClinicaltrials.gov, NCT:02237326, See This study was approved by the ethical review boards at the University of California, San Francisco  and the Kenya Medical Research Institute . This study is registered as a clinical trial  or VILI (N = 330). Reasons for exclusion are shown in There was no significant difference in the performance of VIA and VILI for the detection of biopsy-confirmed CIN2+. The test positivity rates were 26.2% for VIA and 30.6% for VILI (p = 0.22). For VIA, sensitivity was 84.0% and specificity was 78.6%. For VILI, sensitivity was 84.2% and specificity was 76.4%. The positive and negative predictive values were 24.7% and 98.3% for VIA, and 31.7% and 97.4% for VILI. There was a non-significant trend toward increased detection of CIN2+ among women in the VILI arm . When evaluating clinically or histologically diagnosed CIN1+ as an outcome, the sensitivity of both tests decreased, and the specificity increased .When stratifying the cohort by age, CD4+ count, and HAART status, there were several differences on test performance between tests within clinical strata and between strata for a specified test . When coThis large, clinic-based study provides well-validated estimates of the sensitivity and specificity of VIA and VILI among HIV-infected women. In this randomized trial of 654 women, VIA and VILI performed similarly as screening tests for biopsy confimed CIN2+ among HIV-infected women. Sensitivity and specificity were similar to that seen in general populations for both cytology and VIA, although somewhat lower in this study for VILI.,17,27 OvVIA is much more widely studied, recommended and implemented than VILI. ,32 VILI We did find some differences in the performance of VIA and VILI in this population when stratifying by different clinical or demographic characteristics. For example, in contrast to prior work, we saw a decrement in the specificity of VILI, but not VIA in the setting of more severe immunosuppression. Some of that difference may be attributable to increases in sub-clinical infection and inflammation present among women with lower CD4+ counts. We did not, however, adjust for multiple comparisons and, as secondary analyses, these findings are more hypothesis generating than practice changing. Thus, we do not feel that these differences are significant enough to warrant recommending one method over the other.Our study had substantial power to compare the performance of VIA and VILI among HIV-infected women with relative precision and to evaluate the impact of clinical and demographic factors on test performance. Two additional strengths are the use of two separate clinicians for the screening test and confirmatory biopsy to reduce verification bias, and the use of colposcopy and biopsy instead of cytology to determine the outcome measure. While limiting the use of biopsy to only colposcopic exams suggestive of disease or a small proportion of negative exams has been an accepted method for studies validating cervical cancer screening tests, especially those done in resource-limited settings, ,29,30 thThis study contributes to the ongoing evaluation of visual inspection methods for use in resource-limited settings, either in HIV-care and treatment clinics or in high HIV-prevalence areas. The test characteristics presented here will help with program planning, including protocol development and resource allocation. Our findings suggest that both tests performed with similar diagnostic accuracy, with only marginal influence by HIV-related co-factors or age. VIA was more consistent across different clinical or demographic strata. Our findings provide validation of screening tests for resource-limited settings and do not necessarily suggest a change in management or recommendations. In these settings where supplies, time, training, and continued mentorship are limited, it may make sense to focus efforts on a single screening method.S1 CONSORT Checklist(DOC)Click here for additional data file.S1 Dataset(DTA)Click here for additional data file.S1 Protocol(DOCX)Click here for additional data file.