Significant differences remained at the 16 week assessment. Pooled time series regression analyses adjusted for age and sex in the 32 participants who had complete measures at baseline and 24-week follow-up revealed significant time effects for waist circumference and functional measures, with the greatest change from baseline observed at the 24-week assessment.These findings indicate that an evidence-based resistance training program administered in the community setting for those with or at risk of developing type 2 diabetes, can lead to favorable health benefits, including reductions in central obesity and improved physical function. Exercise, along with diet and medication, plays an important role in the management of type 2 diabetes. Resistance exercise may provide unique health and fitness benefits for the treatment of a number of chronic diseases ,2. SpeciTypically, the positive benefits of resistance training have been observed using programs that have involved supervised exercise sessions in well-controlled laboratory, clinical or gymnasium settings. An advantage of this approach is that exercise prescription can be carefully monitored to encourage both appropriate adherence and exercise progression to stimulate metabolic changes. However, from a public health perspective, it is important to understand the effectiveness of maintenance programs undertaken in the community setting. While maintenance programs conducted in the home can provide convenience and flexibility , we haveTraining programs in community facilities such as health and fitness centers or gymnasiums offer greater access to resistance exercise equipment, supervision and group interaction than home-based training. Such training attributes reflect several of the key social and environmental factors that can beneficially influence the maintenance of physical activity behaviors ,10. In ahttp://www.liftforlife.com.au). The goal was to translate the evidence-based resistance training program to existing community health and fitness facilities through the development of a network of accredited providers in Australian cities.In 2005, a major research-to-practice initiative was undertaken that included the development of a community-based resistance training program titled Lift for Life for people with or at risk of developing type 2 diabetes  in Melbourne, Victoria who had received accreditation to implement the Lift for Life program, and who had been an active provider for at least six months, was undertaken in February 2006. The audit encompassed the collation of data that had been collected for each participant in the respective facilities post-accreditation. This involved the photocopying of assessment forms for each participant who had received an initial assessment prior to commencing the program. During the audit process, it was identified that one provider had not complied with the intended assessment procedures and hence this provider was not included in the analysis. For the remaining four providers, the following information was collected for each participant: demographics , waist circumference, upper body strength (arm curl test), agility (timed up-and-go) and lower body strength (chair sit-to-stand). For each participant the initial baseline assessment and the most recent assessment were obtained.As a requirement of the accreditation process, all Lift for Life trainers attend a 2-day training workshop. Within this training, demonstrations of the testing protocols are reviewed along with the provision of written instructions. All trainers are required to provide a satisfactory level of competency with the testing protocols, as determined by a final written assessment.Lift for Life is a progressive resistance training program structured over three phases of approximately eight weeks each  absolute exercise contraindications  were notExisting equipment located in the respective facility was used to ascertain anthropometric measures. Within the Lift for Life procedures, height (cm) was measured using a stadiometer and body weight (kg) was assessed using calibrated scales to the nearest 0.1 kg. Waist circumference was measured using a non-elastic measuring tape at the mid-point between the lower border of the ribcage and the iliac crest. All of the data were collected by the program providers.A validated battery of three physical test items , developStatistical analysis was conducted using Stata version 10.0 . The net differences were calculated by subtracting the changes from baseline for each time point . Descriptive data at baseline was analyzed using paired t-tests. The time effects for anthropometric and functional variables were examined using pooled time series regression analysis for longitudinal data with random effects models. Missing baseline data were replaced with the mean measurement for the respective variable for the total group: waist circumference (1 imputation), chair sit-to-stand (1 imputation), arm curl test (2 imputations) and agility - up-and-go test (3 imputations).At the time the study was conducted, 146 active Lift for Life participants were identified from the four Lift for Life providers Figure . Sixty oThe mean changes in waist circumference, lower body strength (chair sit-to-stand), upper body strength (arm curl test) and timed agility test measurements from baseline to the week 8 assessment for the 86 participants are shown in Table Table The results of this study indicate that the community-based Lift for Life resistance training program was effective for improving waist circumference, lower and upper body strength and agility in adults with or at risk of developing type 2 diabetes. Greater improvements in these anthropometric and functional measurements were seen at the completion of the full 24-week program relative to other testing time points. The findings support the effectiveness of the Lift for Life program for improving health and physical function and reinforce the importance of encouraging individuals to adhere to the full 24-week program to maximize their gains.Previous studies conducted in well-controlled exercise testing laboratories have demonstrated significant reductions in central obesity (waist circumference) following resistance training in individuals with or at risk of type 2 diabetes -18. The Similarly, the improvement in upper body and lower body strength is consistent with previous investigations involving resistance training in this population . The 30%Lift for Life is an example of research translation to the wider community, an important step that is rarely achieved within scientific research. The implementation of an evidence-based program in the Australian community setting is timely given the increased recognition of preventative health care services within public health and government. Such an undertaking requires extensive collaboration between the scientists and the practitioners who are experienced in delivering exercise programs in the community. Invariably, considerable time is required to establish and foster these collaborative links, as evidenced by the fact that the Lift for Life program has been under development for approximately seven years.An increased emphasis on the establishment of community-based resistance training programs for older Australians with and without diabetes, such as Lift for Life, is clearly warranted . While nInterpretation of the study findings is limited by the lack of a randomized controlled study design, an approach that is difficult to achieve in community-based programs that are focused on dissemination rather than scientific research; therefore, the true effect of the intervention is difficult to ascertain. Furthermore, in contrast to the controlled scientific setting, in the 'real-life' community environment there is an increased exposure to having missing data points since data collection was contingent on the instructors adhering to the Lift for Life requirements. Additionally, the assessments at each time point may have been undertaken by different instructors and therefore could have affected the precision of the measurements.Our primary intention for the current study was to provide a snapshot of those participants who had engaged in the Lift for Life program in the metropolitan Melbourne providers. This approach is limited by the timing of each individuals' involvement in the program, as indicated by the fact that substantially less numbers were available for the assessment of the full program (24 weeks) compared to a shorter time frame (8 weeks). Furthermore, given that this evaluation is limited by a convenience sample of providers in one urban location, the results may not be wholly reflective to all Australians, and are more likely to represent urban populations. To enhance generalizability of community-based findings, future studies should seek equal gender representation and address additional socio-demographic characteristics .With the ageing population and the rising epidemics of type 2 diabetes and obesity, it is vital to support and maintain health-enhancing physical activity in the community setting [DWD (as the Lift for Life creator) receives a proportion of the annual payment that Baker IDI attracts from Fitness Australia under its Lift for Life licensing arrangements.KEM performed statistical analyses, contributed to study design and helped to draft the manuscript. GC participated in the design of the study and data acquisition. EU participated in the design of the study and data acquisition. DWD conceived the study, participated in its design, performed statistical analyses and helped to draft the manuscript. All authors read and approved the final manuscript.


Physical, neurological and psychological changes are often experienced differently by male and female adolescents. Positive self-esteem, emotional well-being, school achievements, and family connectedness are considered as protective factors against health-compromising behaviors. This study examines the gender differences in respect to the effect of a school-based interactive wellness program – “In Favor of Myself” – on self-image, body image, eating attitudes and behaviors of young adolescents.Two hundred and ten adolescents (mean age 13.5) participated in the intervention group, 55% were girls and 45% boys. Program consisted of eight 90-minutes structured sessions integrated into a regular school coping skills curriculum. The program focused on self-esteem, self-image, body image, media literacy and cognitive dissonance. The overall impact of the program and the study protocol were previously published.Overall, there are gender related differences in respect to body image and self-image in young adolescents in response to “In Favor of Myself”. Compared to boys, girls reported at baseline higher self-esteem, being more contingent by appearance, and their self-image was more influenced by popularity, appearance, interpersonal communication and admired people. Furthermore girls presented greater gap between current body figure and perceived ideal figure. Not only were girls more dissatisfied with their body, but they were more active in attempts to become and/or remain “thin”. At program termination, gender × time effect was detected in reduction of self-worth contingent by others, change in importance given to achievements at schools, parents' perceptions, as well as the impact of comparisons to friends and family members on self-image.Girls exhibited more gains than boys from ‘In Favor of Myself’ which raise the questions about how effective would be the program when delivered in mixed gender groups vs. mono-gender groups. School-based intervention is a viable mechanism for widespread intervention which has the particular advantage of near universal enrollment of children and adolescents. School-based programs can facilitate change in the environment as well as encourage adopting a healthy lifestyle Previous findings on eating disorder prevention programs have been mixed. Paxton It was suggested that school-based programs should include strongly interactive and participatory components In Favor of Myself addresses the four main areas that were found effective when incorporated in preventive programs A frequently asked question is whether an intervention should incorporate boys and girls together or should be gender specific. This question has not been addressed specifically so far in the research field.Physical, neurological and psychological changes are often experienced differently by male and female adolescents. It has been observed that men assess their physique in terms of strength , while women express concerns related to weight and the shape of certain body parts .Concern for body image differs according to the gender. While boys are concerned with having a muscular body image, girls have beauty ideals that are inseparable from thinness, in most cases below a healthy size Interestingly, some research found that for men, thinking you are less muscular than you really are, is related to higher depression scores and eating disorder symptomology Amongst the sociocultural factors that influence most negatively female and, progressively more, male body image perceptions, are stereotypical ideal body representations, transmitted through different socialization agents and most notably the mass media Although girls have more correct BMI than boys, girls show greater prevalence when it comes to suffering misperceptions of their body image and this creates a greater number of behaviors dedicated to control their weight Although females, more likely than males, might experience eating disorder symptoms and associated risk factors like thin-ideal internalization and self-objectification, there are also many men who feel dissatisfied and concerned about their physical appearance, and may be affected by eating disorders or use steroids The majority of prevention interventions had a focus on the needs of females Our study explored the genders' differences responses to ‘In Favor of Myself’, a wellness program that was evaluated via a longitudinal, controlled intervention study.The study was approved by Tel Hai institutional research board and every parent signed a written consent.Two hundred and ten adolescents  participated in the intervention group. All adolescents in the studied school participated in this study. Only those who filled out the questionnaire on at least two occasions, were analyzed for the evaluation of the program. No differences were observed in baseline variables between those who filled the questionnaire on two or three occasions and those that did not (filled only on baseline) For the purpose of discussing the gender differences in respect to the program impact, only the intervention-group data will be reported according to gender. The overall results of the intervention vs. control were previously published Detailed description of program and process is given in previous publication After receiving Tel Hai Institutional review board approval and parents' informed consent, the baseline status of participants and controls were assessed using a computerized questionnaire which was filled also at program termination and at 3 months follow-up. Twenty trainers (school counselors and teachers) were trained to deliver the program while the task of data collection was assigned to research students. Each participant was given an identification number to ensure confidentiality and anonymity.Demographics, including personal and familial details, were obtained from each participant at baseline. The psychometric properties of the self-report measures were previously described Participants were clustered in 9 program-groups. In order to take into consideration the unit treatment additivity the intraclass correlation coefficient (ICC) was calculated for each variable. Due to reasonable ICC (range of 0.03–0.07) the analyses were performed with all data sets together.2 tests were utilized to assess comparability between boys and girls on baseline measures.The change in scores over time was analyzed after the intervention (pre->post) and over the 6 months study (pre->3 months follow-up). One way analysis of variance (ANOVA) and χ2×3 MANOVA (gender × time) with repeated measure on time was used to assess the difference between genders in changes over time. Statistical analysis was conducted only for those who completed the questionnaire in the three assessment times (210 out of 300 students). No differences in baseline variables were observed between those who filled the questionnaire on three occasions and those that did not (filled only on two occasions).2η  where 0.01 constitutes a small effect, 0.059 a medium effect and 0.138 a large effect Effect size is described using partial For the purpose of discussing gender differences and since the intervention vs. control conditions differences were presented in previous manuscript, we will present and discuss hereby the gender differences among the intervention group participants only.The intervention group included 210 participants, 55% girls and 45% boys, aged 12-14 years old .No statistically significant differences were found between genders in the intervention group in respect to mean age, country of birth, family size and socioeconomic status (assessed by parents' occupation and education).The differences between boys and girls at baseline and at program conclusion in respect to awareness to changes associated with getting older, Rosenberg self-esteem, Others' approval and appearance contingencies of self-worth, knowledge about advertising strategies as well as impact of media on pressure to change oneself and current vs. ideal body image will be described.2 = 0.068). Girls reported on being more aware to life burdens and at the same time perceiving life as more exciting and interesting.At baseline, there were statistically significant differences between genders in awareness to adolescents changes . Gender × time effect was also statistically significant  = 3.23, p = 0.02, partial η2 = 0.053) mainly due to girls reporting on higher increase in perception of life as exciting and interesting when getting older.At program conclusion, MANOVA revealed a significant change with large size effect in both genders' perception about adolescence . Gender × time did not have a significant effect.At follow-up, MANOVA revealed a significant change with large size effect size in both genders perception about adolescence  with no time × gender impact  = 13.03, p<0.000, ηr impact .2 = 0.25]. Moreover, a significant gender × time effect was found in program impact between baseline and program conclusion  Boys exhibited greater reduction in contingencies of self-worth by others, than girls. No gender × time impact has been noted between baseline and follow-up.  = 40.6, p = 0.000, ηllow-up. .Gender differences were also noted when adolescents were asked to estimate on a scale of 1 to 4, the influence of different factors on their self-image .At baseline, girls reported on statistically significant higher values, compared to boys, in their perception of the level of the impact of popularity (14%), appearance (27%), and impact of admired ‘heroes’ on their self-image (18%) . Boys pe2 = 0.056], parents perceptions  and appearance   = 5.77, p = 0.01, partial η = 0.06] . Followi = 0.06] .In respect to identification of media strategies that are endorsed with advertisements, no differences were found between genders at baseline and at program conclusion. A statistically significant time effect with large effect size had been found between program conclusion and baseline in both genders  = 26.6, p =  0.000, partial η2 = 0.12) but no gender × time effect. The improvement in identification of media strategies remained at follow-up .2 = 0.10). Girls reported to be more influenced than boys by the media.In respect to awareness to the pressure to “fix” oneself, endorsed by the media, at baseline, significant differences were found between girls and boys .At program conclusion analysis revealed, in both genders, a significant improvement (reduction in induced pressure) with medium effect size  as well as significant gender × time effect . Univariate analysis revealed a medium size effect of time on drive for thinness  and no effect in body satisfaction  as well as low gender × time effect .At program conclusion MANOVA revealed a statistically significant reduction in EDI in both genders with medium effect size [F = 6.23, p = 0.002, partial η2  = 0.12). No gender × time effect had been noted.At program follow-up, MANOVA revealed a statistically significant reduction in EDI in both genders with large effect size [F = 3.5, p = 0.01, partial ηThe current study aimed to explore the gender differences in respect to the impact of “In Favor of Myself” - a widely disseminated wellness program to promote positive attitude towards growing, positive sense of self and self-esteem and positive body image among adolescents. The program also aimed to promote ability to filter external media and culturally inappropriate messages about diversity of beauty.Overall, the results of this study support and extend previous research suggesting that there are gender differences in respect to body image and self-image in young adolescents. Further, there appear to be some differences but some similarities in how girls and boys are affected by preventive program.Gender differences were statistically significant, already at baseline, in most of the variables. Compared to boys, girls reported to be more contingent by appearance, and that their self-image is more influenced by popularity, appearance, interpersonal communication and admired people. These findings seem to agree with the results of most studies conducted on gender and its relation with appearance, achievement and with self- efficacy and self- esteem In respect to body image, a larger gap has been noted among girls between current body figure and perceived ideal figure at baseline as well as higher awareness to the pressure imposed by media and higher wish to ‘fix’ oneself. Not only were they more dissatisfied with their body, but girls were more active in attempts to become and/or remain “thin”.Researchers support the idea that there are gender disparities in adolescent self-esteem with some claiming that girls having lower self-esteem Studies reported by Fairburn indicate that when adolescent girls are insecure, they become significantly more self-conscious and have greater concerns about popularity, lower body esteem, and lower self-esteem. Self-consciousness leads to increased self-criticism, leaving the adolescent extremely vulnerable to disordered eating Young girls are searching for positive themes with which to identify, to make them feel like they fit in with a group and to make them feel confident. Ideally, the teenager will emerge from the process stronger and more confident, knowing who they are and thinking they know what they want out of life. Unfortunately, this is not always the case The large effect size of gender at baseline questions the appropriateness of providing universal preventive programs to mix gender groups.2 = 0.38) with statistically significance had been found in awareness to changes associated with adolescent due to the intervention but with only small gender × time effect (η2 = 0.053). Girls reported on larger increase in perception of life as exciting and interesting when getting older. Most differences between girls and boys were also detected at follow-up.At program termination, gender × time effect was detected with only girls exhibiting significant increase in awareness to changes associated with adolescence, reduction in contingencies of self-worth by others, increase in importance given to achievements at schools, parents' perceptions and decrease in importance given to appearance in relation to self-image. Boys did not show this trend. A large effect size , while smaller and disperse among boys. Both genders exhibited reduction in drive for thinness with no gender × time effect.below boy's attractive and healthy figures. This trend had been observed during all three assessment point. The impact of intervention on body image was different among genders, but it did not reach a statistically significant effect. In contrast to boys who had demonstrated, during time of assessments, increase in the gap between their current figure vs. ideal or attractive figuresm, in girls the gap decreased. Since the change in boys' gap was not statistically significant it is hard to draw conclusions in respect to these gender opposite trends. Although research documents that some adolescent boys experience body dissatisfaction, these concerns appear to be less pronounced for boys than they are for girls in this age range and less than those of adult males. Hargreaves and Tiggeman Other studies employing the Figure Body Images also showed that in the case of girls the ideal body is substantially smaller than their own, whereas no difference in choice occurred in the case of boys Moreover, the use of body figure ratings to assess men's body image dissatisfaction is problematic because many men want to become more muscular rather than fatter but the figure ratings do not allow them to express this goal. The use of these figure rating scales could explain why previous research has found that men and boys experience fewer body image problems. Most males are not likely to indicate a desire to look like a chubbier figure than they already are  when their real desire is to become more muscular.Flament et al As has been previously reported by us Thus, preventive program should incorporate contents that address global self-esteem as well as appearance-esteem and not only focus on weight-esteem.Since our study has showed that boys exhibited fewer gains from the program in comparison to girls and showed a tendency towards increase in the gap between current figure and ideal or healthy figure, it is very important to explore whether prevention intervention programs may actually have a counter-productive effect on boys and may be girls might gain more from the program when the program is delivered in mixed gender groups. Since boys tend to be less emotionally matured than girls, and less self-conscious about their appearance in mid adolescents years, (when this program is delivered), a long-term follow up should be performed to observe the program impact for both genders.Paxton Limitations of the present study must be acknowledged. Self-report measures may fail to provide reliable information, mainly in respect to eating behaviors and to body misperceptions since we did not use anthropometrical parameters. Moreover, due to limited resources, longer-term follow-up with the current population was not possible. Despite such limitations, the study's longitudinal nature, the intervention that targets multiple risk factors  and the gender × time analysis are major advantages which may provide causal associations among the variables examined.Moreover, it provides information on both male and female adolescents, which enable us to focus on the gender differences and consider which topics might be extended for each gender.Given the differences in individualization-separation processes and ideal body image for males and females, males report pressure for increased masculinity and higher BMI In conclusion, the main objectives of prevention programs conducted in schools should be to identify and criticize the aesthetic beauty model, to develop critical thinking skills and to challenge the glorification of thinness for girls and muscular ideal for boys Since changes brought about by interventions are typically, though not always, short-lived, it is insufficient to have one intervention and then no further support of the ideas and attitudes introduced in the program. Most likely, developmentally appropriate interventions should continue to be introduced throughout childhood, adolescence and young adulthood. Continued interventions or booster sessions need to be considered mainly in light of the reports that programs that were offered to participants over 15 years of age had a greater effect Today, there is no reliable evidence supporting the superiority of either mixed or uni-gender groups thus future studies may benefit from comparing the impact of the program when delivered to mixed gender groups vs. uni-gender groups as well as longer-term follow-up.


The Awareness program was designed as a part of the EU-funded Saving and Empowering Young Lives in Europe (SEYLE) intervention study to promote mental health of adolescents in 11 European countries by helping them to develop problem-solving skills and encouraging them to self-recognize the need for help as well as how to help peers in need.For this descriptive study all coordinators of the SEYLE Awareness program answered an open-ended evaluation questionnaire at the end of the project implementation. Their answers were synthesized and analyzed and are presented here.The results show that the program cultivated peer understanding and support. Adolescents not only learned about mental health by participating in the Awareness program, but the majority of them also greatly enjoyed the experience.Recommendations for enhancing the successes of mental health awareness programs are presented. Help and cooperation from schools, teachers, local politicians and other stakeholders will lead to more efficacious future programs. Every completed suicide has a devastating effect, but when a young life is cut short, the shock is oftentimes even greater. Suicide is a complex phenomenon, thus, the prevention of it needs to be tailored accordingly ,2. PreveStigma, developmental changes and peer pressure lead to adolescents being particularly in need of specifically tailored preventive strategies ,9. YouthTh Framework Health Theme.It is well known that the majority of young people will not actively seek help from professionals, parents, teachers, and oftentimes not even from their peers . With thSEYLE is a randomized-controlled intervention trial (RCT) designed to assess the effects of three different health-promoting intervention programs in comparison with a control group in which a minimal intervention was carried out. The study methodology has been described previously in detail . The int1. Awareness Program – a health promotion program, designed to empower pupils by increasing their awareness of mental health, as well as healthy/unhealthy behavior and teaching them skills to diminish unhealthy behaviors [developed for the SEYLE study by Columbia University and Karolinska Institutet/National Centre for Suicide Research and Prevention of Mental Ill-Health (NASP)].2. QPR  – a gate keeping program designed to educate teachers and other school-based adults in identifying at–risk adolescents and referring them to mental health facilities .3. ProfScreen – screening by professionals for the purpose of identifying pupils at high risk for mental illness and/or suicidal behavior. The program includes a referral procedure, wherein pupils identified as at-risk of mental illness or suicidality were referred to mental health treatment; this program was specifically tailored for the SEYLE study, by the Heidelberg University and Karolinska Institutet/NASP research groups.4. Minimal Intervention (control group) – providing pupils with information materials , containing basic information about mental health . This intervention served as the control arm.In the SEYLE study, effectiveness of the respective interventions on adolescents was compared between the interventions and the control group.In the SEYLE study, the Awareness program was developed to target adolescents between 14–16 years old and to meet their mental health-related needs. The strategy of the program was to integrate different types of learning in order to guide the adolescents through difficult topics. One of the most effective ways to target changes in youth is to combine both a cognitive and emotional training program ,19. CognBefore the implementation of the program and during the preparatory phase, site-visits were made by members of the SEYLE consortium steering group in order to ascertain that the protocol was followed. The site leaders, along with the coordinators of the Awareness program and the instructors appointed to lead the role-play sessions were trained in the many facets of the study methodology; the procedures were stipulated in a detailed 31-page instruction manual . The AwaThe program started with a baseline assessment. The core of the program consists of an opening lecture, three role-play sessions, and a closing lecture with a discussion. In the SEYLE study, each session lasted 45–60 min and the whole program was carried out during four weeks, in a total of five hours plus one additional hour for the baseline questionnaire that served as an introduction and first contact with the students Figure .A didactic and pedagogical booklet Figure : “Affect1) Awareness of mental health2) Self-help advice3) Stress and Crisis4) Depression and Suicidal thoughts5) Helping a troubled friend and6) Getting advice: Who to contactThe booklet of approximately 25 pages was designed for the SEYLE study in close collaboration with a graphic designer who had prior experience in public mental health research and prevention. It was translated, back translated and, when needed, culturally adapted to fit the local languages of the participating sites. In Israel the booklet was translated into both Hebrew and Arabic. The booklet was designed so that it could be kept as a future resource for the pupils at the end of the Awareness program. The content of the booklet served as a framework for the role-play sessions and was introduced to the pupils during the opening lecture in a power point presentation. Similar information was also briefly summarized in the six posters that were hung in the classrooms.In the SEYLE study it was recommended that 10–15 students per instructor participate in the role-play sessions. Through role-play sessions and the ensuing discussions, the students learn about mental health related problems, whilst developing a set of problem-solving skills to assist them in distress, as well as the ability to identify circumstances in which the skills should be applied. They get the opportunity to identify reasons for, and ways to prevent the escalation of problems and to explore the potential effects on the people directly and indirectly involved. In order for role-play to be an effective tool, all questions and thoughts expressed by the pupils need to be thoroughly discussed. This provides the pupils with an opportunity to explore specific situations  that could otherwise appear threatening or difficult in an unsafe environment. They were taught and given the chance to practice how to express empathy, to appreciate other peoples’ perspectives and how to stand up against peer-pressure. The sessions gave also the opportunity to talk about the responsibility of school staff and adults, for example in the case of bullying. Finally, in the closing lecture, all the topics discussed are summarized by using the same power point presentation as in the opening lecture. In this final meeting with the students, particular attention is given to the contact information found at the end of the booklets. In every SEYLE site, local information with the names and telephone numbers of people in the healthcare system and other community-based support networks were provided for students to seek help.In addition to the Awareness coordinators, the program was carried out by a team of competent instructors . The procedures manual stated that the instructor should hold a Masters or higher degree in psychology, public health, social work, pedagogy, or of an equivalent discipline. It was also recommended that the instructor have at least one assistant during the labor-intensive role-play sessions. Some sites even decided to hire professional psychodrama therapists to lead the role-play sessions. The instructors were asked to keep a journal during the time of the intervention program, keeping track of any and all deviations from the protocol and all cultural adaptations.In this descriptive study, the Awareness program field experiences are captured by using first-hand information from the 11 SEYLE sites, as such, generating recommendations and enhancing the future potential of such a suicide prevention strategy.Ethical permission for the project, including the permission to follow up individual pupils, was obtained in each one of the eleven participating countries by their respective Research Ethics Committees, namely: Austria: Ethikkomission der Medizinischen Universität Innsbruck; Estonia: Tallinna Meditsiiniuuringute Eetikakomitee; France: Comité de Protection des Personnes Sud-Méditerranée II; Germany: Ethikkommission Medizinische Fakultät Heidelberg; Hungary: Egészségügyi Tudományos Tanács Titkárság, Tudományos És Kutatásetikai Bizottság; Ireland: Clinical Research Ethics Committee of the Cork Teaching Hospital; Israel: Helsinki Committee at the Rabin Medical Center; Italy: Comitato Bioetico Di Ateneo, Università Degli Studi Del Molise; Romania: Comisia De Etica, A Universitatii De Medicina Si Farmacie, Cluj Napoca; Slovenia: Komisija Republike Slovenije za medicinsko etiko; Spain: Comité Ètico de Investigación Clinica, regional del Principado de Asturias.The SEYLE Awareness program was carried out within well-defined catchment areas in eleven countries: Austria, Estonia, France, Germany, Hungary, Ireland, Israel, Italy, Romania, Slovenia and Spain. In those eleven catchment areas, 179 schools were randomized into one of the four non-overlapping intervention study Arms. The participation rate of pupils was 88% at baseline. A total of 12, 395 pupils from both metropolitan and micropolitan areas participated in the study, of which 6799 were females and 5529 were males (67 subjects had missing gender data), with a mean age of 14.9 ± 0.9. Description of the methodology and material employed is given in another paper . A totalIn this paper, we examine the experiences and opinions about the Awareness program of the 11 SEYLE Awareness coordinators.In order to examine the strengths and weaknesses of the program in this descriptive study, we asked all the Awareness coordinators the following set of open-ended questions about the program implementation.1) What did you like most about the Awareness program?2) What did you like least about the Awareness program?3) What did the pupils like most about the Awareness program?4) What did the pupils like least about the Awareness program?5) How did the schools and teachers like the Awareness program?6) What would you change in the Awareness program if you could?7) What parts of the intervention needed to be culturally adapted for your specific country?8) Was there a difference between the participating schools? Classes? In their willingness to participate, how they participated, what they thought, etc.9) How much effort did the organisation of the Awareness program take?10) In your opinion, was the effort worth the outcome?Upon completion of the Awareness program, the coordinators in all sites were asked to answer the above-mentioned questions in writing.The written answers to the open-ended questions were analyzed by the first and the last author of this paper independently, with the processing of the material performed in a number of steps. As recommended by Pope et al.  the codiTo begin, each response was reviewed independently by two assessors (VP and CW). Secondly, in order to identify emergent topics and to ascertain meaningful and broader themes, words and sentences were grouped together -25. Afterole play and expressing feelings includes what the coordinators described as the possibility of practicing the expression of emotions through acting and improved coordination (with schools and staff) represents organisational difficulties such as scheduling with schools, meeting teachers and headmasters as well as recruiting staff. As a last step, a general description of the responses was written, serving as the basis for the results reported in this article. Issues that were voiced by some sites in particular are emphasised in the result description by adding the name of the country in parenthesis. The Awareness coordinators as well as the principal investigators of each of the sites were given the opportunity to comment on the interpretation of the responses.Importantly, the themes describe multifaceted phenomena that are broad in nature, but for the purpose of analysis are grouped together . SeveralThe Awareness coordinators from all sites drew attention to the particular design of the program that gave space for discussing important mental-health related topics, which otherwise go unaddressed. In 6 of the 11 participating sites , the coordinators underscore that talking about mental health problems and emotions is still uncommon, shameful and stigmatised. Figure From the evaluation results, and as intended, the adolescents used the role-play as an opportunity to discuss their feelings, and they were eager for this kind of experience (Austria). Adolescents particularly appreciated the opportunity to talk about topics such as problem-solving, depression, anxiety, bullying , stress and crisis situations (Spain), pregnancy, conflicts with parents and teachers (Romania), and also suicidal behavior . The experience in France also showed that it was important that positive aspects of health were addressed. In Estonia, it was noticed that, in schools with a higher proportion of children with social problems, more serious topics emerged during the role-play sessions.According to the Awareness coordinators, the program successfully promoted social networks in all countries. Pupils often reported that, when they are in distress, they do not have anyone to talk to . The Awareness program addresses this problem in two ways: First, pupils are informed about different kinds of professional support. Second, the Awareness program promotes peer support. The importance of peer support is emphasised directly with guidelines on how to help a friend in need and indirectly by developing empathy. By participating in the program, the youth got to know each other in a deeper way, often realising that they were not alone with their problems, and that classmates, who they often didn’t know very well, shared similar problems (Hungary). Students also learned the importance of offering support to peers, instead of avoiding their problems, and learned how to do it more effectively. All countries report positive outcomes in this regard. In some cases, the Awareness program also contributed to stronger class bonds (Hungary) or an improved general school-climate (Israel) as reported by students to the instructors.The adolescents and instructors alike appreciated the interactive approach of the Awareness program. The relaxed atmosphere of the role-play sessions proved to be a good point of departure for discussion, and a way to approach the youths’ thoughts and feelings. The instructors often noticed that pupils had difficulties expressing their feelings in words . The role-play sessions provided them with the opportunity to communicate, express and verbalise their feelings, not only to the facilitator, but also to their peers. They were able to overcome their fears of expression, and open up in a more relaxed way . The interactive approach engaged pupils, and they preferred it to the standard classroom set-up, or the ex-cathedra approach, which is still the predominant way of teaching in many schools across Europe. Not only the pupils, but also the instructors, liked the variety of verbal and written materials used in the Awareness program, as well as the more interactive components in contrast to the lectures (Austria). There were reports from all participating countries about students approaching the facilitators after the end of the program, telling them about their problems. Moreover, school counsellors noted that the Awareness program lead to the development of networks with the clinical sector, specifically by providing information on the treatment of pupils in distress, much to the benefit of the perceived quality of care in the schools (Slovenia).The instructor from the Irish site gave the example of how a young boy actively used the booklet as a means to speak to his mother about his feelings and worries. The mother came to the school after one of the sessions to speak to the instructor; she had noticed a marked change in his mood and was very thankful. The instructor also noticed that the boy had become more vocal as the Awareness sessions proceeded.Moreover, the instructors reported changes in the adolescents’ behaviors as the 4-week program progressed; it was evident that, from participating in the role-play sessions, the youth developed problem-solving skills when faced with different situations (Ireland). Additional analyses are required to learn how this potentially translates into everyday life and in preventing mental health problems.The schoolteachers expressed the importance of having a person from outside the school-system to perform the program (Austria), avoiding possible distrust of more familiar instructors. The emotion that they could express their views and emotions in a safe environment, without prejudice and fear of ridicule, was a very powerful aspect . Pupils indicated that they liked that the instructors were open-minded and young, and someone to whom the pupils easily could make a connection with and feel close to. With all of this in mind, it is very important to assemble, train and manage a team able to deliver this kind of program to young people .The shortcomings of the Awareness program, as voiced by the instructors, mostly concern the lack of flexibility due to the RCT design and the tight time frame in the implementation of the workshops. It was difficult to assure that the needs of all pupils were met, or that all topics were equally addressed, explained and/or understood with the same depth. Some topics  were more difficult to comprehend for some adolescents and, thus, a challenge for the instructors to convey in such a brief period of time.The question of allocating more time for role-play sessions, e.g. 2 h instead of 45–60 min, was raised. The current program included an opening lecture that was considered by some to be too theoretical in nature and, consequently, not as well accepted as the interactive role-play sessions . Moreover, pupils thought the time frame for each session was too short (France).A potential obstacle to successfully implementing the Awareness program is the response of the school authorities, school staff, and their parents. In some cases, teachers and school staff were sceptical about the pupils’ motivation to participate in such a program. Ensuring that the entire teaching body appreciates the benefits and efforts of such a program is beneficial to the implementation (Ireland). As the Awareness coordinator typically was in touch with the school principal and guidance counsellors across their site, many coordinators underscored that it proved to be helpful when the principal and/or guidance counsellor were asked to inform all teaching staff about the program. It also happened that some parents and teachers refused or discouraged pupil participation in the program, because they would miss too many classes . It would be helpful therefore to place hand-outs with information about the Awareness program in the staff room in order to ensure familiarity among the entire teaching staff (Ireland). In fact, the benefits of this kind of intervention program may not be obvious to everyone, especially parents . In some schools, the Awareness sessions were scheduled after school and since many pupils attend other after-school activities, this could have influenced participation rates in the program.The most important aspects that the coordinators wish to change in the program are shown in Figure In addition to the role-play, discussions and problem solving that were part of the SEYLE Awareness program, adding other kinds of interactive teaching could further strengthen the program. Among these learning from videos  expressive arts techniques or even action teaching were mentioned (Slovenia).Moreover, in some countries  pupils did not like the posters, as their design or style was not appealing and was sometimes considered too intrusive. This issue can be dealt with by minimising the amount of text on them and by giving more attention to the design. One problem with the posters, in addition to their somewhat simple design, was that they were printed locally, and the quality of the prints varied greatly from site to site. The Awareness and instruction booklets were all printed in Sweden at a printing company and, consequently, were of high quality and uniform across sites.In the SEYLE study, the Awareness program was implemented in an identical fashion across the 11 countries. According to the SEYLE protocol, the sites were encouraged to, if needed, culturally adjust the content of the role-play examples and to account for these adjustments by keeping a journal at the time of program. In some cases, some of the role-play examples from the instruction manual were not used or, if used, applied in a modified fashion. Nonetheless, all participating sites addressed the same topics, as it is important in a cross-country primary preventive RCT to have well-structured tools and clear guidelines on how to work with pupils, so that the instructors could be easily trained, and the obtained intervention results to be comparable across schools and countries.The short time frame of the program (four weeks) was stipulated because of the SEYLE study research-design, aiming to compare different intervention outcomes. For future implementation of this kind of preventive program, the structure and the time frame of the intervention can also be tested, since it is often difficult to offer it in an identical way in different countries and school-settings. The Awareness program stimulates the pupils’ thoughts and feelings, as such, creating a need for a space for continuous discussion, something that should probably be integrated into the ordinary school curriculum. In the Hungarian case, a group of pupils decided to continue meeting together weekly to discuss their problems among themselves at the end of the program. Moreover, coordinators from most of the sites underscored that the program was more successful in those schools where the number of pupils per session was fewer, as well as when more time was given for discussion. It was interesting to note that, in Austria, girls were more interested and open than the participating boys and, in Ireland, boys offered better advice when taking part in the role-play sessions compared to girls, especially, around the topic of pregnancy. In Romania, pupils from smaller towns were more involved and had a lot of questions during the introductory lecture, whilst pupils from bigger towns had higher expectations, expressing views about mental health that they had read about on the Internet and in other sources. Schools with pupils of lower Social Economic Status (SES) had lower participation rates (Hungary) and some adjustments of the program had to be made according the type of school (Slovenia).In summary, the key lesson is to uphold flexibility in discussion with the adolescents, taking into consideration the specific context of every classroom. Despite many challenges with the scheduling of the workshops in different schools and classes and other organisational efforts, all site Awareness coordinators reported that these were well worth it in relation to the satisfaction and appreciation expressed by the pupils . It is also important to have close collaboration with other systems  as specified in the SEYLE protocol, to be able to provide professional help and back-up to adolescents in need.By asking the field coordinators open-ended questions about their experiences we have been able to gain a deeper understanding of the implementation of the Awareness program, complete with its’ difficulties and real-life situations. Research shows that a self-administered instrument of open-ended questions is practical and useful tool for evaluation .The major strength of the Awareness program as proclaimed by the coordinators is its’ subtlety in content and execution. When addressing sensitive issues such as mental health, risky life-styles and suicide, it is important not only to be cautious and sensitive to cultural differences, but also to personal histories. Awareness programs for adolescents that are both effective and culturally adaptable need to be carefully developed, considering attitudes towards suicide and mental healthcare in general. Moreover, suicidal behaviors vary across countries, by gender and across the lifespan -28, withThe SEYLE Awareness program helps the adolescents to develop a large set of skills and knowledge about mental-health: functional knowledge , procedural knowledge (knowing how/having skills) and conditional knowledge (knowing the circumstances in which to use the skills). This know-how is expected to lead to a heightened responsiveness to individuals with psychiatric, behavioral and/or emotional problems, or suicidal individuals, whilst diminishing the general stigma surrounding mental health. Accounts from the field demonstrate that the pupils not only learned new information by participating in the Awareness program, but the majority of them greatly enjoyed the experience.priori defined rules that can be compared across different countries in spite of the many potential, imagined and real cultural differences. Though the school environment provides us with the best setting for programs aimed at adolescents, it is by no means an easy system to navigate and one of the more difficult aspects of the Awareness program was, in fact, the enormous organisational effort required from of the coordinators and their teams working with many different schools and teachers, during a short time period, especially to achieve adequate time in the school curriculum. Of course, the conditions of a study are in many ways much different than those encountered in real life, and we recommend that future Awareness programs take into account the problems encountered in the SEYLE field and the suggestions given here. The structured nature of the current program is inherent to a research study, but in a real-life setting, the time frame for each of the topics raised could be more flexible according to the specific class context and issues raised during the session. The incorporation of video materials and other types of learning methods may also be effective, but needs to be evaluated.Schools provide a well-structured environment that allows large international interventions, such as the SEYLE Awareness program, to run according to a Suppleness in organisation and structure and listening to the thoughts and wishes of the participating adolescents is key to a successful program. The Awareness program is highly contextual and the feedback from the coordinators shows that the local context significantly influences the outcome of the program; every classroom is different, and consequently flexibility is central to a successful implementation. In the case of the SEYLE randomized controlled trial, it was necessary to execute the program in a structured manner to allow for effective comparison across sites through standardised methods. Much of the criticism from the Awareness coordinators dealt specifically with the more rigid aspects of the program; specifically the time frame but also the posters that were deemed too conspicuous in relation to other more adaptable aspects of the program.In summary, the following guidelines can be helpful for people working with youth mental health awareness:• Prepare a well-structured program with clearly defined aims, but allow flexibility and an individual approach.• More time should be allocated to the variety of topics raised and to role-play and discussions with at least an additional five hours added to the program, resulting in a ten-hour program.• Facilitators need to have a proper professional background and training, but also need to have specific personality traits  to create a safe environment.• Topics should be addressed in a way that gives an opportunity to develop problem-solving skills and empathic attitude whilst creating an enjoyable and inspiring experience. Difficult topics should not be avoided, rather need to be addressed with care and close involvement of the participants.• The key messages need to be disseminated through different materials and tools of interaction.• Cooperation, understanding and support from stakeholders are crucial for success; the school system is the most effective system to use. Therefore, logistical issues  need to be tailored according to the needs and available resources.• Holding an information event prior to the Awareness program to encourage teachers and parents to allow the children to participate by providing them with the opportunity to gain a better understanding of the aims and benefits of the program is beneficial. This informal meeting gives the parents an opportunity to meet the awareness coordinator and helps to demystify the program and make it more tangible for parents.• Evaluation of the program should be done with pre-post assessments and also with process-evaluation.The above-mentioned suggestions for successful awareness programs only take into account the issues raised by the set of questions the SEYLE Awareness coordinators were asked. For a more profound understanding of the program and it’s successes and failures, similar questions need to be asked to the participating adolescents as well as to teachers and other school personnel.Only questions with open-ended answers were used in this evaluation. On the one hand, this enabled us to gather a variety of unexpected answers, important for exploring the field experiences. On the other hand, this approach limited the measurable comparisons of the responses to the same items, which is possible when using visual analogue scales. Importantly, this limitation was countered by using a systematic and rigorous approach in the content analysis of the material and summarising results in a meaningful way.The SEYLE Awareness program was developed with a large heterogeneous group of adolescents in mind. The main goals, to increase general mental health awareness whilst encouraging youth to self-recognize the need for help, were, of course, very ambitious. In such large-scale efforts, it is difficult to ensure that the needs of all participants are addressed and that all topics raised are adequately explained and actually understood. However, reports from the SEYLE sites in 11 European countries show that the adolescents not only learned about mental health by participating in the Awareness program, but that it was also an enjoyable and inspiring experience. The role-play sessions and ensuing discussions were a welcome diversion from ordinary classes and as such an excellent tool for communicating knowledge and diminishing mental health related stigma. Different from many other school endeavours, the program engendered understanding between pupils, encouraged peer support and allowed the pupils to get to know each other better, hopefully them to understand that they are not alone with their problems.The school-environment is the best system we have to perform primary prevention programs designed to improve mental health and give information about unhealthy life-styles among youth, whilst at the same time raising the general awareness-level about mental health and mental problems. However, the help and support of schools, local politicians and other stakeholders, along with teachers, parents and adolescents, is needed for efficacious implementation of forthcoming awareness programs. Finally, the healthy functioning and understanding of mental health related issues for children and adolescents have profound consequences for society, both presently and in the future. Therefore, our expectations for the future are that comparable mental health and suicide preventive awareness programs will be included in the curriculums of schools across Europe.The authors declare that they have no competing interests.CW ideated and developed the content of the Awareness intervention program, coordinated the implementation, trained the personnel, analyzed the data and jointly drafted the manuscript. CH ideated and developed the content of the Awareness intervention program, coordinated the implementation, trained the personnel and contributed to the manuscript for relevant intellectual content. DW is the principal investigator of SEYLE, ideated and developed the content of the Awareness intervention program, coordinated the implementation and contributed to the manuscript for relevant intellectual content. VC coordinated the implementation of SEYLE, trained the personnel and contributed to the manuscript for relevant intellectual content. SAH, LF, GF, NG, DCH, MI, JMC, JZ led the Awareness intervention program at the respective study sites, collected the information presented in this manuscript and contributed to the manuscript for relevant intellectual content. DF, KK, PV, AT collected the information presented in this manuscript and contributed to the manuscript for relevant intellectual content. AA, JB, JB, DC, CH, JPK, HK, AV, MS are site leaders of SEYLE in the respective countries. They coordinated and provided support to the implementation of the Awareness intervention program in the respective study sites and contributed to the manuscript for relevant intellectual content. VP was site-coordinator and oversaw the implementation of the Awareness intervention program in Slovenia, analyzed the data and jointly drafted the manuscript with CW. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2458/12/776/prepub


From many empirical and theoretical points of view, the implementation of shared decision making (SDM) in work rehabilitation for pain due to a musculoskeletal disorder (MSD) is justified but typically the SDM model applies to a one on one encounter between a healthcare provider and a patient and not to an interdisciplinary team.To adapt and implement an SDM program adapted to the realities of work rehabilitation for pain associated with a MSD. More specific objectives are to adapt an SDM program applicable to existing rehabilitation programs, and to evaluate the extent of implementation of the SDM program in four rehabilitation centres.For objective one, we will use a mixed perspective combining a theory-based development program/intervention and a user-based perspective. The users are the occupational therapists (OTs) and clinical coordinators. The strategies for developing an SDM program will include consulting the scientific literature and group consensus with clinicians-experts. A sample of convenience of eight OTs, four clinical coordinators and four psychologists all of whom have been working full-time in MSD rehabilitation for more than two years will be recruited from four collaborating rehabilitation centres. For objective two, using the same criteria as for objective one, we will first train eight OTs in SDM. Second, using a descriptive design, the extent to which the SDM program has been implemented will be assessed through observations of the SDM process. The observation data will be triangulated with the dyadic working alliance questionnaire, and findings from a final individual interview with each OT. A total of five patients per trained OT will be recruited, for a total of 40 patients. Patients will be eligible if they have a work-related disability for more than 12 weeks due to musculoskeletal pain and plan to start their work rehabilitation programs.This study will be the first evaluation of the program and it is expected that improvements will be made prior to a broader-scale implementation. The ultimate aim is to improve the quality of decision making, patients' quality of life, and reduce the duration of their work-related disability by improving the services offered during the rehabilitation process. Thereolicies) . In the olicies) ,4. ConseThrough shared decision making (SDM), it may be possible to reduce gaps such as in understandings/representations, values, and expectancies between clinicians and patients. SDM is currently defined by the joint process of decision making of patient and clinician, in which information is exchanged, preferences are expressed and discussed, and agreement is reached regarding the goals and action plan to pursue. Follow-up is also planned for the purpose of evaluating and, if necessary, readjusting the goal or the plan in place . A systee.g., options for returning to work) that may involve a risk, loss, or regret, or go against personal values. The Ottawa Decision Support Framework (ODSF) [Through the exchange of information and discussion of preferences, the SDM process seeks to improve both patient's and clinician's decisional conflict, thus improving the quality of the decision itself and reducing uncertainty when the clinician cannot guarantee a specific result . The levk (ODSF)  specifick (ODSF) . This mok (ODSF) . These dk (ODSF) ,8. Thesek (ODSF) .Based on findings in disability prevention studies, in empirical data in health psychology and psychotherapy, and SDM literature, we therefore propose the general conceptual framework depicted in Figure The objective of this project is to adapt and implement an SDM program adapted to the realities of work rehabilitation for persistent pain associated with an MSD. This will allow for a first evaluation of the program so that improvements can be made prior to a broader-scale implementation during a second phase. The ultimate aim is to improve the quality of decision making, patients' quality of life, and reduce the duration of their work-related disability by improving the services offered during the rehabilitation process. To facilitate attainment of the project objective, we will pursue the following two specific objectives: to adapt an SDM program applicable to existing work rehabilitation programs; and to evaluate the extent of implementation of the SDM program in four work rehabilitation clinics.This study falls into the field of evaluative research . ProgramA mixed perspective, which we have used successfully in prior studies, will combine a theory-based perspective  and a usBy adopting a mixed perspective, combining those of rehabilitation theory and users, we will be able to adapt an SDM program/intervention adapted to the realities of rehabilitation practice. Over and above the users we have identified , we believe that the addition of psychologists, with their expertise regarding the establishment of a working alliance, will significantly contribute to the adaptation of the SDM program.A convenience sample comprised of eight OTs, four coordinators, and four psychologists will be recruited from the following four large rehabilitation centers that have agreed to collaborate: the Centre de réadaptation de l'Estrie; Centre Montérégien de Réadaptation; Centre de réadaptation Lucie Bruneau; and the Centre Hospitalier de l'Université de Sherbrooke. These centres were chosen because they all apply the same work disability evidence-based intervention principles . They wiFor the theory-based perspective, a first conceptual framework for the SDM process was developed based on a literature review and our empirical data. Using this conceptual framework, a first theoretical version will be operationalized  to definUsing this theoretical version, the users will be consulted to allow us to adapt the theory to the realities of work rehabilitation. For this purpose, the Technique for Research of Information by Animation of a Group of Experts (TRIAGE) method  will be 1. The objectives are necessary and essential for a share decision-making process in work rehabilitation. Propose objectives or clarifications of the objectives presented that you deem essential for a SDM process in work rehabilitation; Identify the objectives that are non-essential and that should be removed.2. The objectives are realistic for a context of SDM in work rehabilitation. Please make the necessary changes to the objectives that are not realistic.3. The activities are essential, related to the objectives, and both realistic and feasible. They are formulated in clear and concrete terms. Propose activities or clarifications of the activities presented that are related to the objectives, realistic, and feasible, formulating them in clear and concrete terms; Identify activities that are non-essential and that should be removed.4. The indicators proposed are necessary, sufficient, and appropriate to measure the attainment of the objectives. Propose essential indicators or clarifications of the essential indicators presented that are related to the objectives; Identify the indicators that are non-essential and should be removed.5. The resources  proposed will make it possible to attain the objectives and carry out the activities. They are also sufficient. Propose resources that are essential to attaining the objectives and carrying out the activities.6. Regarding the implementation of the SDM program, the following questions will be asked : The proThe participants' answers will be compiled in preparation for the group meetings. These answers will be written on separate cards, and be discussed in a series of approximately four meetings of the same participants. Each meeting will be limited to a maximum of three hours. At the outset, the participants will be told not to try to produce a perfect SDM program. The second specific objective (first implementation) will enable certain components of the SDM program to be further clarified or possibly modified.The meetings will be recorded to support the notes taken by the research assistant on the group's decisions. A summary will be written up for each group meeting and the literature may be consulted in order to document the emerging data. After the group meetings have been completed, an SDM program adapted to work rehabilitation will be ready for a first implementation.The study protocol has been approved by all affiliated research ethics committees of the participating rehabilitation centres. All experts who agreed to participate to the group consensus will sign an informed consent form. The group consensus session will be held during working hours. The research project will therefore provide financial compensation for the loss of clinical activity time.In order to evaluate the extent of implementation, an exploratory study with a descriptive design will be used . The extA total of eight OTs will be recruited and trained according to the criteria associated with specific objective one. OTs were selected as the relevant professionals because they conduct the initial diagnostic evaluation when a patient is referred to the rehabilitation centre. Also, they are frequently the main health professional involved in the rehabilitation process. The OTs will not be obliged to have participated in the specific objective one phase, given that training will be offered. Moreover, since the OTs have already displayed their interest in participating in this study, according to the innovation dissemination model, they are considered to be 'early adopters,' thus facilitating implementation .Five patients will be recruited for each OT, for a total of 40 patients. The patients will have to be of working age (between the ages of 18 and 64) have been off work for more than 12 weeks due to pain associated with a MSD, and be starting a work rehabilitation program. To promote external validity, only patients with a specific MSD  will be excluded.SDM training derived from theories on innovative intervention implementation ,24 will in vivo exposure. The specific moment during the rehabilitation program for offering the SDM will be clarified during the specific objective one phase. However, it is realistic to think that it will be done at the beginning of the rehabilitation program, following the initial evaluation but prior to establishing the treatment plan. As the patients are referred by a third party (private or public insurers), the referring party expects the goal of the rehabilitation to be a RTW. This goal cannot therefore be modified. In fact, patients who refuse to RTW may lose entitlement to their income replacement indemnities. Despite this situation, our prior studies show that other important decisions can be made [The SDM program will be implemented in the four participating centres that currently offer similar evidence-based rehabilitation programs. In work disability prevention, evidence-based intervention principles include staying physically active , reassur be made ,38. The The clinical program coordinators at the four centres will be our key informants, helping us to identify potential participants in light of the patient inclusion and exclusion criteria. Two weeks prior to the initial diagnostic evaluation, if an OT trained in SDM is asked to evaluate an eligible participant, the coordinator will request the patient's consent to being contacted by a research assistant who will describe the research project. The research assistant will then contact the person by telephone to present the details of the study. Should the patient be interested in participating, the research assistant will meet with the patient before the initial evaluation to have the consent form signed and to answer any questions the participant may have. This procedure will enable the patient to make a clear distinction between the research process and the usual clinical interventions.The patients who agree to participate will undergo their initial diagnostic evaluation as planned in the clinical procedures. Toward the end of this meeting, the SDM process will be launched. This last segment of the meeting will be audiotaped by the OT to avoid bringing a third person into the meeting and possibly changing the dyadic dynamic. At the end of the meeting, the research assistant will take the recording to be transcribed and will invite the participant and OT to complete a self-administered questionnaire independently and confidentially.Once an OT has completed this procedure with five participants, he or she will be asked to participate in a semi-structured individual interview for the purpose of documenting the factors hindering and facilitating implementation of the SDM process. The same research assistant will conduct the interviews.Informed consent will be sought from the injured workers. The OTs will have to sign a new consent form each time a patient agrees to be involved in the SDM process. The training in SDM will be held during working hours. The research project will therefore provide financial compensation for the loss of clinical activity time.The SDM activities carried out by the OT/patient dyad will be recorded and evaluated using the OPTION observation scale , for whiTo triangulate the observational data, a validated dyadic questionnaire on the working alliance  will be e.g., patient-related, legal or administrative context, et al.)? Are there typical cases in which the SDM process did not work particularly well? What were the characteristics of these cases ? Which prescribed objectives or activities in the SDM program theory did you feel most comfortable using? With which ones did you feel least comfortable? Why? Can you make any suggestions to improve the program theory?Semi-structured individual interviews will serve to document the OTs' perception of the factors hindering and facilitating SDM implementation. The following questions will be asked: Are there typical cases in which the SDM process worked particularly well? What were the characteristics of these cases (At the end of these questions, the interviewer will present the interviewee with the aggregate results of the OPTION scale ratings for the five cases he or she is managing, to maintain the confidentiality of the individual results. These results will be presented in a respectful manner to avoid blame and to promote the emergence of explanations and theories as to the differences between what was done and what was prescribed.a priori codes. These codes will come from a taxonomy of barriers and facilitators of implementation of SDM [Descriptive analysis will be performed on the scores of the questionnaire completed by each member of the dyads. The transcript of the 40 SDM processes will be analyzed by two independent evaluators using the OPTION rating scale to obtain a score for implementation. Qualitative data analysis of the individual interviews with the OTs will be done to determine whether the OTs carried out the SDM process successfully as prescribed in the program theory. For this purpose, content analysis will be performed using a list of n of SDM . Howevern of SDM . The intn of SDM . The codn of SDM  is obtaiCurrent studies across the various health fields in SDM only offer objectives or general recommendations . To the This is a pragmatic study involving a limited number of clinicians. Therefore, further generalization and confirmation of the findings will be necessary with additional clinical environments and larger subject groups. This study, however, is a necessary step because the content of the innovative SDM process must be adapted to work in the disability prevention field. We realize that the conceptual framework is a simplified model addressing only a portion of the complex interactions between the stakeholders and patients in the work disability process.The design and multiple theory-driven basis of this study will help prevent the problem that frequently arises during the evaluation of complex interventions: that the program was not clearly defined or not thoroughly developed . We willThe authors declare that they have no competing interests.MFC wrote the study protocol and conceived the study. FL contributed with her expertise and in the writing on SDM concept and training, as well as identifying the assessment of the SDM activities. MJD brought her expertise in the methods section on program evaluation, she contributed to the elaboration of the interdisciplinary work rehabilitation program and acted has a mentor to MFC. MC participated with his expertise in working alliance concept and its assessment. DS contributed with her expertise on SDM concepts and training. PL participated with his expertise on work disability prevention he contributed to the elaboration of the interdisciplinary work rehabilitation program and acted has a mentor to MFC. LB brought her expertise in interprofessional education and knowledge transfer expertise in clinical settings. MFC is its guarantor. All authors contributed in obtaining the funding. All authors read, edited, and approved the final manuscript


Electron microscopy studies indicated that IgM+AnnV+PI+ apoptotic cells exhibited morphologically advanced apoptosis with marked plasma membrane disruption compared to IgM-AnnV+PI+ apoptotic cells, suggesting that access to intracellular epitopes is required for IgM to bind. Strong and comparable binding of IgM to permeabilised non-apoptotic and apoptotic cells suggests that IgM bound epitopes are 'apoptosis independent' such that IgM may bind any cell with profound disruption of cell plasma membrane integrity. In addition, permeabilised erythrocytes exhibited significant IgM binding thus supporting the importance of cell membrane epitopes. These data suggest that IgM may recognize and tag damaged nucleated cells or erythrocytes that exhibit significant cell membrane disruption. The role of IgM in vivo in conditions characterized by severe cell damage such as ischemic injury, sepsis and thrombotic microangiopathies merits further exploration.Autoimmunity is associated with defective phagocytic clearance of apoptotic cells. IgM deficient mice exhibit an autoimmune phenotype consistent with a role for circulating IgM antibodies in apoptotic cell clearance. We have extensively characterised IgM binding to non-apoptotic and apoptotic mouse thymocytes and human Jurkat cells using flow cytometry, confocal imaging and electron microscopy. We demonstrate strong specific IgM binding to a subset of Annexin-V (AnnV) The pathophysiology of many autoimmune diseases is associated with perturbations in the highly regulated processes of apoptosis and subsequent clearance of apoptotic cells by phagocytes –3. DurinThe development of autoantibodies, particularly against cytoplasmic or nuclear antigens which characterizes diseases such as systemic lupus erythematosus (SLE), has been suggested to be a consequence of excessive levels of apoptosis and/or compromised clearance . HoweverImmunoglobulin class M (IgM) antibodies have been shown to mediate and accelerate the clearance of apoptotic cells by phagocytes –27, a fuper se. These findings suggest an important role for IgM in the recognition of nucleated cells and erythrocytes that have lost significant membrane integrity.In this paper, we sought to explore why circulating IgM antibodies may exhibit preferential binding to late apoptotic cells. As membrane integrity differs considerably between early and late apoptotic cells –7 we hypad libitum access to food and water. Animal procedures were performed in accordance with guidelines set out by the United Kingdom’s Home Office under the Animal (Scientific Procedures) Act of 1986 and were approved by the University of Edinburgh’s Biological Services Department. Mice were sacrificed by cervical dislocation according to the United Kingdom’s Home Office Scientific Procedures Act Schedule 1 regulations. Total mice used: 99.Balb/c or RAG1-deficient mice were purchased from Harlan, UK or Charles River. Mice were housed in the Biomedical Research Resource Unit at the University of Edinburgh and were given Cell culture reagents were purchased from Life Technologies, Paisley, UK. Chemicals and reagents were purchased from Sigma Aldrich, UK unless stated otherwise.2 to generate a cell population with variable levels of apoptosis. Following incubation cells were centrifuged at 230 x g for 6-minutes, and washed with PBS.Following cervical dislocation thymi were dissected from 4–8 week old male Balb/c mice. Thymocytes were dissociated by grinding thymi through a cell strainer . Thymocytes were used immediately or aged overnight in RPMI 1640 at 37°C and 5% CO2. Cells were cultured at a density of 2x106/mL and apoptosis induced by incubation with 0.5μM camptothecin for 16-hours. Cells were then centrifuged at 300 x g for 6-minutes, and washed with PBS.Human Jurkat cells  were cul2. HK-2 cells were detached with trypsin or cell dissociation buffer. Morphology was assessed by microscopy using a Zeiss Axiovert S100 with an x32/0.4 objective and imaged using a CoolSnap RS Photometrics camera and OpenLab software. Whole image contrast/brightness and pseudocolour was adjusted using ImageJ (NIH).HK-2 cells  (kindly Cells (excluding erythrocytes) were permeabilised using the following saponin based reagents purchased from eBioscience and used according to manufactures instructions: Fixation/Permeabilisation Concentrate (Ref: 00-5123-43), Fixation/Permeabilisation Diluent (Ref: 00-5223-56) and Permeabilisation Buffer 10x (Ref: 00-8333-56). To confirm permeability 1μL PI [1mg/mL]  diluted 1:20 in PBS was added to samples before analysis by flow cytometry on a BD FACSCalibur. For confocal microscopy permeability was confirmed by Annexin-V staining only as described in ‘Annexin-V (AnnV) and Propidium Iodide (PI) staining’.5 cells (excluding erythrocytes) were incubated in PBS or 30% human serum (Sigma Aldrich) (Jurkat and HK-2) or 12.5% Balb/c or RAG1-deficient mouse plasma (thymocytes) for 30-minutes. For thymocytes APC Mouse  IgM κ isotype control  was used as control irrelevant mouse IgM antibodies to assess non-specific interaction. This was used at a high concentration to be comparable to levels of IgM found in mouse plasma (0.22 ±0.036 mg/L). IgM binding was detected by a 30-minute incubation with the following IgM μ chain specific antibodies: FITC mouse anti-human IgM  and APC rat anti-mouse IgM  diluted in 1% BSA. Annexin-V and PI staining was then performed.Approximately 5x102) and incubated for 15-minutes. PI was used as above. Cells were designated non-apoptotic (AnnV-PI-), early (AnnV+PI-) or late (AnnV+PI+) apoptotic. Staining was assessed by flow cytometry on a BD FACSCalibur  and analysed using FlowJo (TreeStar).PtdSer exposure was detected using Alexa Fluor-647, FITC or PE conjugated Annexin-V  diluted in AnnV binding buffer  according to manufactures instructions. Texas Red goat anti-mouse μ chain specific IgM (SouthernBiotech) was used and samples were stained with DAPI (Invitrogen) and PI staining was omitted. Jurkat cells were treated and stained as above with the addition of DAPI and omission of PI staining. Samples were mounted using ProLong Gold antifade reagent (Life Technologies) and viewed using a Leica SP5 with an x63/1.4 objective. Single stains were used to check for spectral-bleed through. Whole image contrast/brightness and pseudocolour was adjusted using ImageJ (NIH) or Adobe Photoshop CS5.Sorted thymocytes were fixed in 3% glutaraldehyde in 0.1M sodium cacodylate buffer, pH 7.3, for 2-hours and washed thrice in 0.1M sodium cacodylate for 10-minutes each. Post-fixation was performed by a 45-minute incubation in 1% osmium tetroxide in 0.1M sodium cacodylate before samples were washed thrice in 0.1M sodium cacodylate for 10-minutes each. Samples were dehydrated by 10-minute incubations in 50%, 70%, 90% and 100% normal grade acetones before a further two 10-minute washes in analar acetone. Samples were embedded in Araldite resin and 1μM sections cut on a Reichert OMU4 ultramicrotome. Sections were stained with Toluidine Blue and suitable areas for investigation selected by light microscopy. From selected areas 60nM ultrathin sections were cut and stained with uranyl acetate and lead citrate before viewing in a Philips CM120 transmission electron microscope. Images were taken on a Gatan Orius CCD camera. Whole image contrast/brightness was adjusted using ImageJ.g for 10-minutes. The buffy coat was discarded and erythrocyte pellet was washed in PBS and centrifuged at 600 x g for 10-minutes thrice before being diluted x3.5 in PBS.Total blood was collected via cardiac puncture from terminally anesthetized mice into Multivette 600 Lithium Heparin coated tubes (Sarstedt). Plasma was collected following centrifugation at 1500 x x g for 10-minutes. Permeabilisation was achieved by a 10-minute incubation in 0.05% saponin after which erythrocytes were washed. Erythrocytes were incubated in PBS or Balb/c or RAG1-deficient mice plasma at a ratio of 1:1 (erythrocyte volume:plasma volume) for 30-minutes before being washed. APC Mouse  IgM κ isotype control was used as control irrelevant mouse IgM antibodies. IgM binding was detected by a 30-minute incubation with APC rat anti-mouse IgM. AnnV staining was performed as above to confirm permeabilisation. Samples were diluted in AnnV binding buffer before staining was assessed by flow cytometry on a BD FACSCalibur. Erythrocytes were identified by Ter-119 positivity (defined by isotype controls) and 5000–10000 Ter-119+ events were collected and analysed using FlowJo.Isolated erythrocytes (200μL) were stained with Alexa Fluor-488 rat anti-mouse Ter-119/Erythroid cells antibody  for 30-minutes before being washed with PBS and centrifuged at 600 t-test, Kruskal-Wallis one-way ANOVA or two-way ANOVA with Dunn’s or Bonferroni multiple comparisons test when appropriate. P < 0.05 was considered to be statistically significant. Statistical analysis performed using Prism 6 .Results expressed as means ±SEM. Statistical tests used: student + thymocytes and assessed the percentage of AnnV+IgM+ thymocytes   or plasma from RAG1-deficient mice, which are deficient in both IgG and IgM –66. Prevymocytes . IgM binnti-IgM) . Additioymocytes . ApproxiM+ cells . AnalysiM+ cells . As expeur plots . The abseraction .+PI+ cells and the differing FSC/SSC profiles of the AnnV+IgM+ and AnnV+IgM- cell populations. CellTracker Green labelled thymocytes were sorted into AnnV-IgM-, AnnV+IgM- and AnnV+IgM+ populations by FACS and examined by confocal microscopy. Unsurprisingly AnnV and IgM staining was absent in sorted AnnV-IgM- cell populations . For flow cytometry analysis PI staining was used to indicate permeabilisation. Saponin treated non-apoptotic thymocytes were PI+ indicating successful permeabilisation and demonstrated a dramatic shift in IgM positivity whilst non-saponin treated non-apoptotic thymocytes remained negative for both PI and IgM (n = 4 per group). A small proportion of apoptotic thymocytes were PI positive representing late apoptotic thymocytes but nearly all cells became PI positive (>99%) following permeabilisation with saponin  compared to those incubated in PBS . For flow cytometry analysis PI staining was used to indicate permeabilisation. Following permeablisation non-apoptotic Jurkat cells were predominantly PI and IgM positive (>98%), whilst non-saponin treated non-apoptotic Jurkat cells remained consistently PI and IgM negative .To determine if circulating IgM could interact with intracellular antigens present within non-lymphoid cells we examined IgM binding to saponin permeabilised human proximal tubular epithelial (HK-2) cells; a cell line derived from normal adult human kidney . A distiere IgM+  .Although confocal microscopy studies of AnnVhrocytes . Successhrocytes  and the assessed . IgM bin+ cells by complement components that may be recognised by phagocytes [Circulating IgM antibodies play a non-redundant role in apoptotic cell clearance, evident by the development of autoimmune disease in IgM-deficient mice , 32. IgMagocytes , 28–30. +PI+ apoptotic thymocytes with IgM+ cells exhibiting a different FSC/SSC profile to AnnV+PI+ apoptotic thymocytes that were IgM-. These data suggested a fundamental difference in the properties of IgM+AnnV+PI+ apoptotic thymocytes, with potential epitopes bound by IgM either being absent or inaccessible in IgM-AnnV+PI+ thymocytes. Apoptosis consists of multiple temporal stages defined by morphological changes such as nuclear pyknosis, vacuolation, cell shrinkage and the presence or absence of plasma membrane integrity [+IgM+, with the membrane of said cells exhibiting marked disruption with obvious ‘holes’ evident. This contrasted IgM negative AnnV+PI+ cells, which retained a predominantly intact cell membrane. These profound morphological changes are likely to account for their different FSC/SSC profile evident on flow cytometry. The relevance of our carefully controlled mouse IgM binding data to human cells was provided by similar findings in studies of apoptotic Jurkat cells. These flow cytometry and morphological studies of IgM+ or IgM- apoptotic cells suggest that the binding of IgM (MW 970kDa) requires physical access to the cellular interior via a severely disrupted cell membrane and that such access is not provided by the loss of cell membrane integrity that is defined by positive staining with propidium iodide (MW 0.67kDa). This model is schematically depicted in IgM antibodies preferentially bind late apoptotic cells , 47–49. ntegrity . Confocaide MW 0.kDa. Thisde novo during apoptosis by caspases or other enzymes, or by other forms of cell stress, such as oxidation. Following saponin permeabilisation both human and mouse thymocytes became strongly IgM+, irrespective of whether they were non-apoptotic or apoptotic. Also, human renal tubular (HK-2) cells became strongly IgM+ following permeabilisation indicating that the presence of intracellular epitopes capable of IgM recognition is not confined to lymphoid cells. Furthermore, we found that IgM bound a significant proportion of permeabilised mouse erythrocytes. Erythrocytes are anucleate with few organelles and a biochemically less complicated cell membrane compared to nucleated cells, such as lymphocytes. These data suggested that at least a proportion of epitopes recognized and bound by IgM within this study are cell membrane associated. IgM antibodies bind a diverse range of epitopes, although it is clear that studies predominantly report binding to membrane phospholipids that are modified during apoptosis such as by oxidation [et al., (2002) indicates that IgM binding occurs following the activation of a specific phospholipase (iPLA2). This phospholipase remodels apoptotic cell membranes exposing IgM bound phospholipids. This further supports the concept that IgM binding is restricted by accessibility to IgM bound epitopes.A key question concerned the nature of the epitopes recognized by IgM and whether these epitopes were generated xidation , 54–59. These data indicate that IgM is able to recognize and bind epitopes present within both normal and apoptotic nucleated cells thereby suggesting that IgM bound epitopes are not generated by the activation of caspase cascades associated with apoptosis. Indeed, the presence of such apoptosis-independent epitopes within normal cells could provide the substrate for IgM binding to cells that have undergone any form of cell lysis such as primary necrosis secondary to ischaemia etc. or cell injury induced by granzyme/perforin or complement . The binin vivo in conditions such as ischemic injury, sepsis and thrombotic microangiopathies.In conclusion, these flow cytometric and morphological studies indicate that circulating IgM specifically binds to cells that have progressed through apoptosis such that they have developed marked plasma membrane disruption that allows IgM to access intracellular epitopes. Studies of IgM binding to permeabilised lymphoid and parenchymal tissue cells indicate that both normal and apoptotic cells possess intracellular epitopes that can be recognised by IgM. Lastly, permeabilised erythrocytes also exhibit specific IgM binding. The totality of these data suggest that an important function of circulating IgM is to recognize and tag any nucleated circulating or resident tissue cell or erythrocytes that is severely damaged and exhibits significant plasma membrane disruption. Subsequent activation of complement and opsonisation would promote clearance of these severely damaged cells by phagocytes. Further work is required to define the role of circulating IgM in the specific clearance of nucleated cells and erythrocytes with severely compromised cell membranes S1 Fig-) and apoptotic (AnnV+) thymocytes. A) Representative histogram indicating that unconjugated mouse IgM control antibodies do not bind to AnnV+ thymocytes. B) Apoptotic thymocytes were gated on the basis of AnnV positivity and the percentage of AnnV+IgM+ thymocytes was assessed. IgM binding in isotype control and PBS treatment groups remained non-significant whilst samples exposed to Balb/c plasma exhibited significant binding . Data representative of n = 5 per group. Data expressed as means ±SEM.Mouse thymocytes were rendered apoptotic by overnight culture. Thymocytes were then exposed to either purified mouse pentameric isotype control antibodies  IgMκ isotype control), PBS or Balb/c plasma (as a source of IgM). Following incubation with an anti-IgM antibody, the binding of IgM was assessed by flow cytometry. Annexin-V (AnnV) staining, assessed by flow cytometry, was used to determine the level of non-apoptotic (AnnV(TIF)Click here for additional data file.S2 FigMouse thymocytes were rendered apoptotic by overnight culture. Thymocytes were then exposed to either PBS, Balb/c plasma (as a source of IgG) or plasma from immunodeficient RAG1-deficient mice that does not contain IgG. Following incubation with an anti-IgG secondary antibody binding was assessed by flow cytometry. IgG binding in PBS, Balb/c plasma and RAG1-deficient mice plasma remained minimal. Data shown for a representative histogram (n = 4 per group).(TIF)Click here for additional data file.S3 Fig-IgM-, AnnV+IgM- and AnnV+IgM+ populations Click here for additional data file.S4 Fig-) and apoptotic (AnnV+) cells. Apoptotic Jurkat cells were gated on the basis of AnnV positivity and the proportion of AnnV+IgM+ Jurkat cells was assessed. A proportion of apoptotic Jurkat cells exposed to human serum or Balb/c plasma exhibited IgM binding. Representative histograms are depicted (n = 4 per group).Human Jurkat cells were treated with camptothecin for 16-hours to induce apoptosis. Jurkat cells were then exposed to PBS or human serum as a source of IgM prior to incubation with anti-human IgM antibody. Some Jurkat cells were exposed to PBS, Balb/c plasma as a source of mouse IgM or purified mouse pentameric isotype control antibodies  IgMκ isotype control). Samples were then incubated with an anti-mouse IgM antibody. IgM binding was assessed by flow cytometry. Annexin-V (AnnV) staining, assessed by flow cytometry, was used to determine the level of non-apoptotic (AnnV(TIF)Click here for additional data file.