Infant Program: a group-based obesity prevention program facilitated by maternal and child health nurses within first-time parent groups. Six 1.5 h sessions were delivered at three-month intervals when the infants were 3–18 months. A multi-site qualitative exploratory approach was used, and program service providers and parents were interviewed. Numerous interrelated factors were identified, linked to two themes: the transition to parenthood, and program processes. Personal factors enabling engagement included parents’ heightened need for knowledge, affirmation and social connections. Adjusting to the baby’s routine and increased parental self-efficacy were associated with diminished engagement. Organisational factors that challenged embedding program delivery into routine practice included aspects of program promotion, referral and scheduling and workforce resources. Program factors encompassed program content, format, resources and facilitators, with the program being described as meeting parental expectations, although some messages were perceived as difficult to implement. The study findings provide insight into potential strategies to address modifiable barriers to parental engagement in early-year interventions.The ‘early years’ is a crucial period for the prevention of childhood obesity. Health services are well placed to deliver preventive programs to families, however, they usually rely on voluntary attendance, which is challenging given low parental engagement. This study explored factors influencing engagement in the  The ‘early years’, more recently defined as the first 1000 days (conception to 24 months), is widely acknowledged as a crucial period in laying the foundation for life-long learning and development . GloballParents and carers play a significant role in influencing the health and development of their children, and supporting parents to develop their knowledge, skills and confidence regarding child health and development is considered an important public health strategy ,10,11. FAustralian parents are highly receptive to information and support during the first year of their infant’s life, making an average of 11 visits to their general practitioner and 14 visits to their maternal and child health nurse, with the majority of these unrelated to illness . The uniExamining patterns of attendance is considered important to determine if there are sensitive periods when attrition is more likely to occur , and theEnablers and barriers to engagement are most commonly categorised into personal, organisational and program factors. Personal  factors include socio-demographics; physical, financial and emotional resources; and social supports ,35,36,37Studies of the enablers and barriers to engagement have most frequently been conducted in the context of children with behavioural ,25,30,32This study is an exploration of the factors influencing the engagement of first time parents in an early childhood group-based obesity prevention program, from the perspectives of both program service providers and parents across all levels  of program attendance. For the purposes of this study, parental engagement is defined as program recruitment (promotion and enrolment) and program retention (ongoing attendance). Infant Program. R.L. is a postdoctoral researcher with experience in research translation, with specific involvement in evaluating the community-wide implementation of the Infant Program. K.C. is a professor and chief investigator of the Infant Program, responsible for its development, randomised control trial, community-wide implementation, and ongoing evaluation. Ethical approval for this study was obtained through Deakin University (HEAG-H 160_2016) and the Victorian Department of Education and Training (DET 2016_003167). This study used a multi-site qualitative exploratory approach, underpinned by a contextualist epistemology, where knowledge emerges from and is situated within the contexts of the data . UnderstInfant Program is a low dose, efficacious, group-based program for first time parents . There were a lot of things that I was, like, ‘oh now we can do this’ and ‘I should be doing this’. It was really good. I took a lot of notes”“I learned a lot from it. I knew nothing about solids or how to introduce them or when to introduce them. I walked away with a clearer idea … That was the first place that I really learned about that. If I hadn’t gone there I don’t know where I actually would have learned that except from a relative” “It was just nice to have somebody there who was going through the same thing really … you didn’t feel judged because you were all going through that, yeah, having that level of friendship really helped” overwhelming”, “daunting” and “stressful” period, hampering attempts to self-refer or attend program sessions. The desire not to interrupt baby’s routine  was a commonly described barrier across all categories of attendance, further reducing the likelihood of self-referral and attendance. Non- and low attendees, and parents with lower levels of education, described a reliance on informal sources of information, such as family members, friends with children, the internet, and social media, which was viewed as a substitute for program attendance. Parenthood posed some barriers to program attendance in the form of low levels of parental self-efficacy, receiving conflicting information and guidance from informal sources (such as family and the internet), and returning to work. Non-attendees described parenthood as an ““I know it’s really good to get out of the house, but I just felt—and there’s so much pressure to do it. I actually felt like a bit of a failure, because I wasn’t getting there” “I’d attend if it wasn’t his sleep time. I wasn’t going to wake him to go” growing sense of confidence as a parent, especially once infants had transitioned to solid foods; and with mothers returning to work at around 12 months. For high attendees, returning to work was also described as resulting in a loss of social connections with other mothers, which reduced their likelihood of attending the remaining (15- and 18-month) program sessions. Across all study sites, program service providers identified two time periods when program attendance declined; session 3 (infants about nine months) and session 4 (infants about 12 months). Program service providers and low attendees concurred that the main reason for program attrition around nine months was a A number of enablers and barriers to program attendance were described in relation to aspects of program promotion, referral, recruitment, enrolment, scheduling, and delivery. Program promotion and referral‘Key Ages and Stages’ appointments by new parents, program service providers considered the maternal and child health services to be an appropriate mechanism for program promotion and referral. Non, low and high program attendees concurred with this, describing the maternal and child health service as a “highly trusted source of information and referral”. Limited program awareness was considered a barrier by program service providers and participants across all categories of attendance. Parents suggested that promotion of the program should ideally be before the birth of the baby to create early awareness and encourage attendance ahead of (feeding) issues arising, and that this could be done via usual appointments with midwives, general practitioners, obstetrics and gynaecological services during pregnancy. Program promotion through local government websites, libraries, lactation consultants, child care centres, social media, community events and local newspapers was suggested, with non- and low attendees recommending that promotional material should include information about the program content.Given the high uptake of the Program recruitmentnew parent groups as highly efficient, providing a captive audience with existing social connections. Low and high attendees also described new parent groups as important in establishing trusted friendships, which encouraged program enrolment and attendance. Across all study sites, program service providers considered recruitment through existing “I think it’s probably the best way, I would say between 80 and 90% of parents going to those groups would actually express interest … and that cut out a lot of the admin of me trying to follow-up with people, because they were already coming together”“It probably helped hearing about it in the [new parent] group, because I think I went along to at least the first session with some other mums from the same group”every child is different”.The recruitment of new parents who were not members of new parent groups was a challenge for program service providers, and a concern shared by some parents, with the suggestion that multiple promotional channels be used. Some parents commented on the program only being offered to first-time mothers, suggesting that multiparous women be able to attend as ““I’ve got a 2 year gap between my two, so my little one is 6 months old, and there are things that you forget … Perhaps a little refresher course” “It would be great to be able to attend as a second or third time mum for a refresher”Across all study sites, program service providers were concerned about reaching vulnerable parents, specifically Aboriginal parents, culturally and linguistically diverse (CALD) parents, adolescent mothers and disadvantaged parents, who were unlikely to attend new parent groups. Working in partnership with other organisations already accessing these communities was a common suggestion to extend program reach, although this was also considered to be time intensive, requiring additional financial and human resources to adapt program content and delivery. “I don’t think we’re doing a fabulous job of reaching, perhaps, vulnerable families as well as we could be, because they’re not necessarily the families that are going to participate in a new parents group for whatever reason … We’ve probably got the groups there that we could partner with, and I think that’s been one of my really big learnings—don’t try and do it yourself, partner with the agencies that are already in contact with those groups, because there’s absolutely no point in setting it up and doing it yourself” “Often what it takes to engage those more vulnerable families is a lot more work. A lot more time—probably more funding in terms of you know—you’d often need an interpreter. Sometimes you would need an extra staff member, potentially to run a program or to run a session if you had families there who were, you know, English as a second language” Program enrolmentopt-out enrolment approach, with participants automatically enrolled in all sessions from the start, was described positively by program service providers and high attendees. In addition, the integration of the first session of the Infant Program as the last session of new parent groups provided immediate exposure to the program content and format, encouraging program enrolment. While an opt-in  enrolment approach was considered by some program service providers as providing flexibility and a degree of accountability to parents, most described this as an administratively burdensome task. Low attendees also described self-referral as an activity likely to be forgotten given the spacing of the program sessions at three-monthly intervals. Reminder notifications, sent by text message at least a week ahead of a scheduled session, were considered useful, especially given the spacing between sessions and changes to the baby’s routine. Parents suggested that the content of the forthcoming session be promoted with the reminder notification to enhance interest and attendance.An Program scheduling and deliveryprogram venues were considered safe, comfortable and accessible , with adequate parking and space for prams. Providing multiple session options on different days/times was a challenge for program service providers, constrained by the availability of staff and the need to ensure an adequate group size with infants of the same/similar age. Parents reported that limited session options reduced flexibility to attend when circumstances such as the baby’s routine changed, or to accommodate working parents, including fathers. For all study sites and across all attendance categories, “I’m still sort of thinking how we could do that … engage a bit better with fathers … as far as what their working arrangements are” “It’s difficult because your baby obviously does sometimes change their sleep patterns and that sort of thing … It would have been nice to have a bit more options for time” “I thought maybe it would be nice to have two sessions, one in the afternoon and one in the morning, not necessarily on the same day, because that might be really difficult, but maybe in the same week. Just to give parents an option … even after-hours so dads might be able to come”appropriate group size with infants of the same/similar ages was described as an administrative challenge across all sites, and particularly problematic for  areas with low birth rates. Reaching vulnerable parents through existing infrastructure, such as supported playgroups, added further complexity to scheduling, as these groups comprised multiparous mothers and infants of varying ages. Scheduling infants of approximately the same age within groups, however, was appreciated by low and high attendees as it enabled the delivery of program content using an anticipatory guidance approach, providing age-appropriate, timely information. The scheduling of participants to ensure an “I think getting a critical mass of babies at the right age is actually quite difficult … and that is the case for a number of [rural] areas. I think you need a really good system for that, otherwise it becomes all-consuming” “It was going to be age appropriate … If someone had have just thrown a book at us when the kids were born, it wouldn’t have been helpful”group-based format of the program was regarded as an enabler by program service providers and low and high attendees. This format was viewed as providing a relaxed, friendly environment that encouraged peer discussion, social connections and trust, with suggestions that a group size of 10–15 parents was appropriate for good group dynamics.The “The real advantage of these groups is that you do build that trust, and families do feel supported”“I’m a bit of a shy person, so I liked that I could just sit there quietly but still feel part of it. There was no pressure. People asked questions; I didn’t have to, because other people asked valid questions. Then there were conversations going on. It was nice to hear that everyone is on the same page as you”“The main thing I got out of it was listening to other people, their experiences … some real reassurance I suppose and knowing that you were in the same situation as other people, having the same week as other new mums”formal sources of information, with group facilitators described as “trusted”, “knowledgeable” and “approachable”. Dietitians were valued for their specific nutritional knowledge and maternal and child health nurses for their expertise in child health. While parents appreciated the technical knowledge and professional expertise of group facilitators, they expressed a need for them to have experience as a parent, or at least some practical experience working with infants.Across all categories of attendance, parents with higher levels of education showed a preference for hands on” advice, especially recipe ideas. The program resources were valued by parents, with a preference for hardcopy handouts at sessions “to refer to at home” and digital sources that could be accessed if unable to attend.Parents enjoyed external speakers (such as dentists or first aid instructors), and practical ““It would have been good to have extra information emailed to you if you couldn’t attend a session”“Perhaps it could be recorded … like if someone misses a session or you want to re-look at something … or be available online”“I’ve stuck it [handout] on the fridge … from the first session and I still refer to it. It’s good to have something to take away because it’s just really overwhelming”program content appeared to be a barrier for low attendees with higher levels of education, who considered certain messages to be either “too prescriptive”, “too general” or a duplication of the information received at their maternal and child health appointments. Program content regarding screen time recommendations was recalled most often as behaviour that would be difficult to implement given the insidious use of digital technology. Certain aspects of the “They [participants] were often quite surprised to hear the recommendations were no screen time up to two years, and there were lots of questions about ‘well what do we do as parents then for our own sanity?’”“I guess I was a bit disappointed, it didn’t really tell me anything that I didn’t already know. I guess I expected to get more hands on experience out of it. I felt like it was really just general healthy eating guidelines” “Parts of it were great and I got a lot out of it but there were parts where I just thought, ‘I feel a bit judged now’. It was like ‘this is the recommendation’”frequency and spacing of sessions, with a preference for fewer sessions (2–4 rather than 6), spaced closer together (“perhaps monthly” rather than three months apart), completed earlier (within 12 as opposed to 18 months), and linked to reliable sources of digital information. Linked with periods of program attrition, especially after session 4, suggestions were made by program service providers and program regarding the “Three months is a long time in between … if we were to condense it into a shorter timeframe that would be helpful because really, you know, they really need the advice maybe monthly”“We weren’t getting many 15 and 18 month attendees … now we go to the 12 month and we send them out a text message with a link to the [program] website so they can still have access to the information, and they’re more than welcome to call up” Infant Program were related to two interconnected themes: the transition to parenthood and program processes; and across these themes, enablers and barriers were linked to personal, organisational and program factors. This is one of few studies examining the parental engagement specifically of first-time parents in an early childhood obesity prevention program from the perspectives of program service providers and program participants with varying patterns of attendance. The factors affecting parental engagement in the parental knowledge and self-efficacy; social connections, and sources of information and support. A heightened need for knowledge and assurances, especially infant feeding information, and opportunities to share experiences and develop social connections, were described as primary motivators for enrolling in the Infant Program. These enablers, however, were thwarted if parenthood was experienced as stressful and overwhelming, adjusting to the baby’s routine was challenging, and informal sources of information were substituted for program attendance. Personal factors included Program attendance appeared to diminish with the acquisition of knowledge and growing confidence as a parent, especially once infants had transitioned to solid foods; and early program termination appeared to be linked to a loss of social connections with the group once parents returned to work. The link between reduced program attendance and increased parental self-efficacy is consistent with other studies where parents with a lack of confidence in their parenting abilities and a belief in the program benefits were more likely to see the relevance and importance of program attendance ,32,33,35Infant Program is considered a success, despite it potentially leading to reduced program attendance. To this end, the program encourages the attendance of sessions by others involved in the care of the infant  to build a shared understanding of program messages and increase the likelihood of their implementation. Research also continues regarding the efficacy of social media  as a means of directing Infant Program participants to reliable sources of information [Increased parental self-efficacy as a result of attending the ormation ,54,55.A reliance on informal sources of information and support from family, friends with children, the internet and social media, appeared to become a substitute for program attendance, especially for program participants with lower levels of education. Participants with higher levels of education appeared to seek out ‘reliable’ information and showed a preference for formal sources of support, in particular the maternal and child health nurse. These findings are supported by other studies, where the preference to access formal sources of information was found to increase when parents developed a good relationship with the source ,21,34,56program promotion and referral; recruitment; enrolment, scheduling and access. Promotion and referral through the maternal and child health service via routine ‘Key Ages and Stages’ consultations was regarded as an efficient mechanism, given the high uptake of this service and frequency of contact. Broader program promotion, especially prior to the birth of the baby, was recommended, however, to increase program awareness. A lack of program awareness, as identified in this study, is frequently cited as a practical barrier to engagement [Organisational factors affecting parental engagement included gagement ,32,36, ogagement . Effectigagement . Studiesgagement ,60, to pgagement ,18,20. Infant Program via new parent groups was considered an enabler, providing access to parents with infants of the same/similar ages and with existing social bonds. The source of program referral is described in the literature as an important contributor to the likelihood of attendance, with referrals from trusted sources [Recruitment to the  sources  . Providing a narrow range of program times has been reported to limit the attendance of parents with busy schedules , time coThe program venues were described by study participants as accessible, safe and comfortable, thus enabling program attendance; with high patterns of attendance within the rural study site (62.5%). Physical access to programs is described as an important enabler in many studies, especially in rural areas where public transport may be limited or costly ,32,33,36content, format and resources; and delivery by trusted individuals. Program content focused predominantly on infant feeding and active play and therefore met the expectations of participants, however, messages perceived by participants as difficult to implement, such as screen time recommendations, were described as ‘prescriptive’ and ‘judgemental’, especially by program participants with low patterns of attendance. Similar findings have been seen among low program attendees expressing fears of being judged by others or not possessing the necessary skills [Infant Program, participants enjoyed the inclusion of external speakers (such as dentists or first aid instructors) and peer advice (recipe ideas) to augment program information. The group-based approach was described positively by program participants and program service providers, encouraging group discussions and providing opportunities to form social contacts. Nobles and co-authors describe group size as a strong predictor of parental engagement, and found that groups of fewer than 20 participants, as opposed to one-on-one, encouraged social interaction and promoted a sense of belonging [Program factors affecting engagement encompassed the program y skills ,36 and sy skills . The eviy skills ,32. Simielonging . The important role played by group facilitators in creating an environment for social bonding is closely linked to the personal need of participants to share experiences and seek reassurance, often reducing feelings of isolation and normalising concerns . The abiAcross the study sites, the provision of experienced professionals to facilitate groups was a challenge when workforce capacity was stretched by existing clinical workloads. The integration of program implementation as routine practice, thereby attracting organisational resourcing, was described by one study site as a means of addressing workforce capacity. Studies note that the turnover of staff is likely to affect relationship-building and impact program attendance, suggesting the continuity of group facilitators throughout program delivery ,27. These findings align with those identified by others, where parental engagement was enhanced when the program met the expectations and needs of the participants , the proThe study findings provide insights into the factors influencing parental engagement in an early childhood obesity prevention program, and therefore also highlight the changes needed to address modifiable barriers to engagement. While numerous studies focus on the influence of personal factors on parental engagement, there is growing acknowledgement that the majority of modifiable factors are likely to be found within the program and/or its implementation ,27,37. TFuture research considerations include obtaining perspectives from a larger sample of non-attendees, as well as fathers and parents of different ethnicities. Understanding the predictors of engagement for these cohorts could provide additional insights into the strategies needed for equitable program access and uptake, thereby extending the reach, cost-effectiveness and health benefits of the program.Box 1Broader program promotion through multiple channels, with more information about program content and benefitsEarlier program promotion during pregnancy and through initial home visits/home support service, with an opportunity to address potential barriers to attendanceContinued program promotion and referral through trusted sources of information and support, especially maternal and child health services with routine contactCross-promotion and referral through interagency collaborations, especially to reach vulnerable parentsRecruitment through established groups, especially new parent groups, with existing social bonds and groups reaching vulnerable parentsEasy, “opt out” enrolment processes, with automated text reminders a week in advance reminding parents of the focus of the next sessionAlignment of program messages with maternal and child health services, to reach those not attending, and reinforce messages for those attending the programProgram facilitation by maternal and child health nurses and dietitians for their specific expertise, and continuity of group facilitators to build relationships Program adaptations to deliver all sessions within 12 months, to accommodate parents returning to workWhere feasible, providing a variety of session times , accompanied by online program delivery and resources, to ensure a reliable source of information and to support a flexible mode of delivery , especially for working parents, fathers, and geographically dispersed communitiesA key strength of this study is the review of the whole engagement process, from program promotion, referral and enrolment, to implementation and attendance. The study is strengthened further by the inclusion of perspectives from program service providers experienced in all aspects of program implementation across three diverse geographic locations. Although the characteristics of the interviewees were comparable with those of the total sample of survey respondents, this study only interviewed English-speaking, female parents, and had a low overall response rate (10.6%). The study findings may therefore not be representative of all program participants and should be extrapolated with caution. The enablers and barriers identified in this study are similar to those in the literature, however, and therefore could be considered to have broader relevance and transferability to similar programs.As is usual for qualitative studies, the sample size and diversity were challenged by the fact that the responding individuals were likely to be more motivated and to have been more engaged in the program, and that not all participants who expressed interest were interviewed as they were uncontactable or declined. Stratification by program attendance assisted the inclusion of multiple perspectives from non, low and high program attendees. While numbers were small, the inclusion of non-attendees also provided insights into attendance decisions for this typically under-reported cohort. Infant Program, appears to meet this need. Maternal and child health nurses who have an established relationship with parents through routine and regular contact, provide a trusted point of referral to the program, and are in a position to positively influence attitudes to program enrolment from the first home visit after birth. Adaptations to program delivery may be necessary to extend recruitment beyond new parent groups in order to reach more vulnerable parents, where groups are more likely to have infants of mixed ages, and parents from multicultural backgrounds. The transition to parenthood is associated with a period of heightened receptiveness to information and guidance, especially in relation to infant feeding. This transition is also associated with the need for social connections and shared experiences with other parents. A group-based program delivered during the first year of parenthood providing reliable, age-appropriate messages on relevant topics such as feeding, active play, sleep and safety, such as the Infant Program highlight a number of personal, organisational and program barriers and enablers that are interconnected around the adjustment to parenthood and the need for knowledge, reassurances, and social connections. Identifying and understanding these factors is important so that appropriate strategies can be developed to enhance parental engagement and participation in ‘early years’ interventions.The factors influencing parental engagement in the The study findings provide important insights into the decision-making processes of new parents adjusting to parenthood and factors influencing program attendance. An exploration of the enablers and barriers experienced by program service providers advances our understanding of the implementation context and ability to support parental engagement.


Non-technical skills are emerging as an important component of postgraduate medical education. Between 2013 and 2016, a new blended training program incorporating non-technical skills was introduced at an Australian university affiliated hospital. Program participants were medical officers in years 1 and 2 of postgraduate training.n = 68).An interdisciplinary faculty trained in simulation-based education led the program. The blended approach combined open access online resources with multiple opportunities to participate in simulation-based learning. The aim of the study was to examine the value of the program to the participants and the effects on the wider hospital system. The mixed methods evaluation included data from simulation centre records, hospital quality improvement data, and a post-hoc reflective survey of the enrolled participants . Supplementary revision sessions were made available to the cohort with a median weekly attendance of five participants. 56/68 (82.4%) of survey respondents reported increased confidence in managing deteriorating patients. During the period of implementation, the overall rate of hospital cardiac arrests declined by 42.3%. Future objectives requested by participants included training in graded assertiveness and neurological emergencies.Implementation of a non-technical skills program was achieved with limited simulation resources and was associated with observable improvements in clinical performance. The participants surveyed reported increased confidence in managing deteriorating patients, and the program introduction coincided with a significant reduction in the rate of in-hospital cardiac arrests. Transitioning from undergraduate to postgraduate practice is a recognised challenge . Junior ‘Non-technical skills’ in healthcare include communication proficiency, decision-making, and teamwork , 6. The Non-technical skills can be acquired through both hands-on experience and through specific ‘Crisis Resource Management’ (CRM) training. The latter refers to the combination of teaching technical skills and non-technical skills with the recognition that both are essential components of safe patient care . While lIn 2013, our interdisciplinary faculty reviewed a series of local adverse events involving junior doctors attending Medical Emergency Teams (MET) calls. Specific analysis of these adverse events led by the local Advanced Life Support (ALS) committee suggested an association between clinical errors and suboptimal non-technical skills. As a result, it was postulated that specific training could be beneficial. The overall aim of the new program was to improve patient care by making sustainable improvements in meaningful areas such as handover and communication, while giving the doctors an approach to common MET call emergencies. Given the tension that exists between a junior doctor’s service provision and their need for training, it was determined that an innovative approach was required. After stakeholder consultation, we developed a targeted program . The protocols for the study were examined and approved by the Western Sydney Local Health District (WSLHD) research and ethics committee.For the purpose of this study, a ‘Junior Doctor’ was defined as a postgraduate year 1 ‘intern’ or postgraduate year 2 ‘resident’ starting their training between 2014 and 2016. Invited participants were junior doctors employed by the hospital on a 2-year contract. During pre-briefings, participants reported a variety of past exposure to simulation-based medical education in their undergraduate studies. Faculty were from both medical and nursing backgrounds and had specific skills in emergency medicine, anaesthesia, and critical care. In addition, hospital management and secretarial staff provided key support to the program.The design of the program was divided into three distinct parts Fig.  13–15].–15.13–15Part 2 consisted of a 4-h face-to-face course. The program objectives were divided into approximately vailable .breathing’, ‘circulation’, or ‘disability’) with a matched 40-min simulation activity. The content for Part 3 was derived from core content presented in Parts 1 and 2 of the program [Part 3 consisted of scheduled revision sessions for participants who had enrolled in Part 1 and 2 of the program as well as other after-hours junior doctors that were on duty . Part 3  program .The target audience were doctors rostered on after-hours (afternoon) shifts. In the afternoon, there is a period of double staffing and therefore significant redundancy created by overlapping shifts. Faculty also reported that this time period (3.30 pm–4.30 pm) was favourable for them. While pragmatic, this approach to allocation led to unequal distribution in access across the cohort due to the variance in clinical rostering. As a result, a portion of enrolled doctors did not participate in all components of the program.By using a relatively quiet portion of the doctors’ clinical commitment, Part 3 allowed for simulation-based learning without many of the typically associated costs . The timn = 13) and nursing (n = 8) backgrounds. Training in simulation-based education included the completion of the National Health Education and Training in Simulation (NHET-Sim) course [Participant debriefing was undertaken by trained faculty from medical  course .Following a 20-min skills station and 10-min simulation, a debrief was facilitated for 30 min. The terminal debriefs were not scripted. However, the debrief was structured into four phases . Time was equally allocated to clinical issues and non-technical skills . The debThe program was evaluated using a mixed method evaluation Fig. . Simulatn = 169) were invited by e-mail to respond to an anonymous online survey about their experience of the program in April 2016. Sixteen questions  was achieved by 169/283 (59.7%). The online course materials (Part 1) were accessed a total of 939 times . The folThe faculty delivered 82 brief simulation-based revision sessions (Part 3) over the study period. Each revision session had a median attendance of five doctors (range 2–9). Overall, 48/68 (70.5%) of surveyed participants attended one or more of these sessions. Variance in rostering resulted in revision sessions being attended by rotating doctors who had not enrolled in the Part 2 course and some enrolled participants attending multiple sessions.Overall experience of the program was rated ≥6/10 by 65/68 (95.6%) of survey respondents Table . 56/68 . 49/68  [From a local point of view, the main perceived benefit of this program was an initiation of culture change in our medical emergency teams. The importance of the relationship between team training and patient safety has been described in other settings (e.g. STEPPS™) . In our STEPPS™) .Simulation-based education is applicable to many different disciplines and levels of experience , 25. FroIn regard to costs, the simulation portion of the program was significantly strengthened by the use of ‘in kind’ resources and an interdisciplinary faculty Table . From ouWhile the majority of participants stated that they would benefit from more simulation training Table , our repIn terms of limitations, our survey response rate (40.2%) was lower than anticipated which may have led to non-response bias. The sub-optimal response rate was in part due to restrictions placed by the approving ethics committee in contacting participants (limited to an e-mail invitation from the postgraduate manager). While the approach of our program aimed to maximise long-term recall through regular revision, we did not assess participants with objective measures of their performance. From the results, we note that increased confidence following training is pleasing but that ‘self-rating’ following simulation should be considered a low-level outcome measure . FurtherAcquisition and retention of non-technical skills is a current challenge in postgraduate medical education. Successful implementation of a new non-technical skills program was aided by support from hospital management and direct involvement of the faculty in quality improvement committees. In our experience, training for junior doctors was achievable even with limited simulation resources. Retention of new skills and culture change was supported by longitudinal opportunities for additional simulation. Program implementation coincided with a yearly decline in the hospital cardiac arrest rate and resulted in a self-reported increase in confidence by the participants.


To determine the role of immunoglobulin M (IgM) deposits in clinical manifestations, disease outcome, and treatment response of idiopathic and secondary focal segmental glomerulosclerosis (FSGS).Kidney biopsy specimens of 171 patients diagnosed with FSGS (primary and secondary) and 50 control patients were retrospectively included in the study. For each patient, clinical and outcome data were obtained and compared to morphological parameters, including immunofluorescence analysis of mesangial IgM and complement 3 (C3) deposits analyzed on kidney biopsy samples.P < 0.001) and between IgM and mesangial deposits detected by electron microscopy in secondary FSGS (P = 0.015), which indicated that higher IgM deposition correlated with higher C3 deposition and mesangial deposits only in secondary FSGS. Patients with secondary FSGS and the deposition of IgM showed inferior renal outcomes at earlier time points in comparison with patients with negative IgM expression (P = 0.022).There were significant positive correlations between IgM and C3 deposition in secondary FSGS (We detected a positive correlation between IgM and C3 in secondary FSGS. The association between IgM deposition and worse renal outcome in secondary FSGS indicates that IgM may play a role in the progression of this disease. Focal segmental glomerulosclerosis (FSGS) is a clinicopathological syndrome that usually manifests clinically as nephrotic syndrome and morphologically as focal and segmental glomerular sclerosis under light microscopy (LM), a foot-process effacement under electron microscopy (EM), and occasional immunoglobulin M (IgM) deposits in immunofluorescent (IF) analysis -5. Both In addition to FSGS, mesangial deposits of IgM can be found in various primary and secondary renal diseases, such as minimal change disease, mesangioproliferative glomerulonephritis, hypertensive nephrosclerosis, and diabetic nephropathy -12. The Recently, the presence of IgM in non-sclerotic areas of glomeruli has been explained by specific natural IgM binding to neoantigens exposed in injured or stressed glomeruli . The recThe aim of our study was to investigate the potential correlation between IgM and C3 mesangial deposits in kidney biopsy tissue of patients with both primary and secondary FSGS. The hypothesis tested was that the presence of IgM deposits in non-sclerotic areas may predict disease progression in some patients irrespective of disease etiology.We retrospectively analyzed kidney biopsy specimens and clinical data from diagnostic biopsies obtained between 2003 and 2014 at the Department of Pathology and Cytology of Dubrava University Hospital in Zagreb, Croatia, including kidney biopsy samples of 171 adult patients with biopsy-proven FSGS and 50 control subjects consisting of consecutive patients diagnosed with either thin glomerular basement nephropathy or without significant changes on renal biopsy specimen. The diagnosis of FSGS was made according to the FSGS definition in the Columbia classification , cholesterol level, triglycerides level, plasma protein level, blood pressure, plasma IgM level, creatinine level, creatinine clearance, 24-hour proteinuria level, and serum albumin level. Clinical data during treatments and follow-up were collected from medical records. Comparison analyses were performed on available collected data.2 and calculated according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula (Estimated glomerular filtration rate (eGFR) was expressed in mL/min/1.73 m formula .Standard therapy for patients with primary FSGS consisted of a corticosteroid with immunosuppressive agents including cyclophosphamide, cyclosporine A, and tacrolimus and combined with renin-angiotensin-aldosterone system (RAAS) blockade. Patients admitted after 2012 received treatments according to the Kidney Disease Improving Global Outcomes (KDIGO) guidelines .Renal biopsy was performed in all patients at the time of diagnosis. Renal specimens were evaluated using LM, IF, and EM. The material for LM was cut into serial sections. Each section was alternately stained with hematoxylin and eosin, periodic acid-Schiff, Masson’s trichrome, and Jones’ stain. Immunofluorescence was made on a frozen sample, and serial sections for direct IF were stained with antibodies against IgG, IgA, IgM, C3, C1q, fibrinogen, albumin, and the kappa and lambda light chains . The tissues for EM were processed using standard methods  and examined using a JEOL 1400  electron microscope.The histological type of FSGS, total number of glomeruli, number of glomeruli with global and segmental sclerosis, presence, quantity and distribution of IgM and C3 deposits, foot process effacement, degree of interstitial fibrosis and tubular atrophy, arteriolar hyalinosis, and arterial intimal thickening were determined. The histological type of FSGS was defined according to the criteria established by a group at Columbia University . The degPolyclonal rabbit anti-human IgM/ fluorescein isothiocyanate (FITC) and Dako FITC-conjugated rabbit anti-human C3c complement antibodies (Dako) were used according to the manufacturer’s directions. Positivity for IgM and C3 was determined semiquantitatively in snap-frozen sections. Only diffuse, global distribution of IgM and C3 in nonsclerotic areas was considered positive , and the2 test  and a Mann-Whitney U test . Spearman correlation coefficients were used to analyze associations between IgM, C3 levels, and EM mesangial deposits in primary and secondary FSGS. Kaplan-Meier survival curves were used to study prognostic relevance, and corresponding log-rank (Mantel-Cox) test of equality for survival distributions was used to analyze different levels of IgM and C3 in primary and secondary FSGS over time for renal outcomes and response to treatment. Binary logistic regression was performed to analyze the impact of the number of different predictors on the likelihood of disease progression or complete or partial remission. Results were expressed as odds ratios (OR) with 95% confidence intervals (95% CI). If the P value of the candidate predictor in univariate survival analysis was <0.05, the predictor was included in the multivariable regression model. All statistical analyses were two tailed, and a P value <0.05 was considered as statistically significant. The data analysis software system IBM SPSS Statistics, version 21.0 , was used for statistical analysis.The normality of the data distribution was assessed with the Kolmogorov-Smirnov test and appropriate non-parametric tests were used in additional analyses. Differences between the FSGS and control groups and between the primary and secondary FSGS groups were analyzed with a χOf a total of 221 patients included in the study, 50 patients were in the control group and 171 in the FSGS group. Male gender was predominant in the combined (primary and secondary) FSGS patient group . AdditioA comparison between the primary and secondary FSGS groups showed that the secondary FSGS group had significantly higher values of BMI, systolic blood pressure, total serum protein, albumin, serum creatinine, and number of globally sclerotic glomeruli . Serum cThe FSGS group had a significantly higher prevalence of positive IgM deposition and positive C3 deposition than the control group . CompariAccording to the correlation coefficients between IgM and C3 deposition with other clinical and histological variables in primary and secondary FSGS, there were significant positive correlations between the IgM and C3 deposition and between IgM and mesangial deposits on EM in the secondary FSGS group, indicating that IgM deposition is associated with C3 deposition and EM mesangial deposits only in the secondary FSGS group . There wTables 4 and 5P = 0.001).Although there was no significant difference in response to treatment between primary and secondary FSGS  when shown as a binary variable, the significantly higher prevalence of partial remission was found in secondary FSGS (P = 0.018).Log-rank Mantel-Cox test of equality for the survival distributions of different intensity of IgM and C3 on IF for response to treatment  in the primary and secondary FSGS groups over time showed that patients in the primary FSGS group with positive C3 on IF reached response to treatment at an earlier time point than patients who had negative results for C3 on IF (P = 0.048). Male gender was only significant predictor of disease remission among patients with primary FSGS .To determine the risk factors for response to treatment  among patients with secondary FSGS, we used univariate and multivariate analysis. On univariate level, three significant predictors were found: urinary protein level, eGFR, and interstitial fibrosis and tubular atrophy (IFTA). In multivariate analysis, only lower concentration of urinary protein was found to be a significant predictor of disease remission  and number of re-biopsies. Patients in the secondary FSGS group who had more IgM deposits on IF reached the composite renal outcome at an earlier time point than patients with lower or negative IgM deposition P = 0.022Our study showed that intraglomerular IgM and C3 deposits were frequently detected in both primary and secondary FSGS without the correlation with other relevant immunofluorescence parameters. Similarly to a previous study , our resZhang et al  were theThere is a historical controversy about the relevance of glomerular IgM deposits in the progression of nephrotic syndrome in pediatric and adult patients ,23-29. IThe limitations of our study are a small number of patients, especially those patients with primary FSGS, and retrospective design. Also, our study provides correlations and not a pathophysiologic proof of concept. However, we provide first human biopsy report in adult patients with secondary FSGS showing that two classical intraglomerular immunoflourescence parameters (IgM and C3) may contribute to the clarification of this very heterogeneous group of patients. Although interventions aimed at modulations of complement effector molecules are increasingly used in autoimmune renal diseases and transplantation, we believe that further analyses are necessary to draw conclusions about benefits of this kind of treatment in FSGS therapy .In conclusion, this study showed a possible role of IgM deposition in secondary FSGS, indicating that IgM may serve as a novel predictor of disease progression. In our opinion, a further survey of the presence and possible pathogenic role of IgM in glomerulonephritis should be performed. Prospective studies with a larger patient cohort and therapy information are warranted to definitely define the role of IgM in patients with faster progression of FSGS.


The Massachusetts (MA) Department of Public Health engaged the Injury Prevention Center at Boston Medical Center to develop a statewide baseline (2012) inventory of evidence-based (EB) community falls prevention programs for community-dwelling older adults.n = 825) serving older adults was deployed in two parts. The Directors’ survey determined if a falls prevention program had been offered in 2012, the salience (rating of importance) of falls prevention for the organization, and intention to offer future falls prevention programming. A falls prevention program offered in 2012 triggered a second survey of Director-designated Coordinators to obtain information on programs’ dates and locations. For the last program offered, data were collected on the number of participants, the training and occupations of program facilitators, and program funding. The last programs served as a cross-sectional sample of all programs offered during 2012.A web-based survey of organizations (N = 457) and 86 % (N = 112) for the Directors’ and Coordinators’ surveys, respectively. The mean salience score for falls prevention was 3.68, on a 1–5  scale; 12 % of respondents indicated offering ≥1 evidence-based program during 2012. We documented 107 EB programs, the majority of which (83 %) were offered by public agencies that serve older adults.Response rates were 55 % (Infrastructure for deployment of EB falls prevention programs is developing in MA, despite the absence of institutionalized funding, legislative mandates, widespread referrals from healthcare providers, or health insurance reimbursement. Falls are significant and costly public health problems that affect millions of older adults nationwide. At least 30 % of those ages 65 and older experience at least one fall each year and half of these fall repeatedly  for falls prevention , the Massachusetts Department of Public Health (DPH) engaged the Injury Prevention Center (IPC) at Boston Medical Center to develop a statewide baseline inventory of EB community falls prevention programs for older adult Massachusetts residents living independently. A web-based survey was developed to count and characterize these programs during the index year 2012. The aim was to provide the MCFP, DPH, organizations that serve older adults, and other stakeholders with baseline data on statewide community-based falls prevention infrastructure. By identifying gaps in program availability by geography, facilitator training, and funding, the results could inform the development of strategies and resource allocation to enhance the state’s infrastructure for community-based falls prevention. To our knowledge, this is the first statewide inventory of EB falls prevention programs for community-dwelling older adults.Listed in the second edition of the CDC’s falls prevention program compendiumListed as a third evidence tier falls prevention program by the AOA7. To satisfy the Sherrington criteria, the program must consist of at least 50 h of exercise, offer a balance component, and exclude a walking component  falls prevention is secondary to their missions and (2) each group has a large number of members, which would have made it difficult to obtain reliable response rates.N = 30), Councils on Aging , YMCAs , Community Health Centers , Assisting Living Residences , Home Health Agencies , and Community Action Agencies . For each category of organization, a tailored survey format was developed in collaboration with representatives of the organization . Tailoring included minor language changes in instructions, and for clinical organizations , language that distinguish therapeutic services from community-based falls prevention programs. The data collected, however, were consistent across organization categories.Categories of organizations targeted by the survey were Area Agencies on Aging/Aging Services Access Points  designated by the director.The survey was administered on the web in two parts. The first part, the Directors’ survey, screened for organizations that conducted falls prevention programs in 2012. If a director indicated that his/her organization conducted or hosted a falls program (evidence or non-EB) in 2012, a second more detailed survey (Coordinators’ survey) was sent to a staff person  details. Directors were asked, “Does your organization intend to directly provide or host a falls prevention program for your clients during 2012–2014?” Directors were also asked about the salience of falls prevention for their organization, using the following question: “Given the various services that comprise your organization’s mission, please indicate on a scale of 1 to 5 (1 = low priority and 5 = high priority) the priority of falls prevention programming for your clients.” The Directors’ survey took 5–10 min to complete.This survey was sent to individuals designated by directors who indicated that at least one falls prevention program had been conducted or hosted by the organization in 2012. Designated coordinators were asked to confirm that a falls prevention program had been conducted or hosted in 2012, and, as in the Directors’ survey, they were asked to identify which programs were conducted using lists of EB programs and other related activities. For each EB program identified by coordinators, we collected the following information for each iteration thereof: (1) start date, (2) end date, (3) location, and (4) whether the program was offered directly or hosted by the organization. When programs began in 2011, but ended in 2012 or began in 2012 and ended in 2013, they were considered to have occurred in 2012 the index year.In some cases, the director indicated that the organization had provided EB programs, but the coordinator indicated that this was not the case. When there was conflicting information regarding the offering of programs, we relied on the Coordinators’ data based on the assumption that coordinators were most apt to have accurate information. It is possible, however, that a few directors might have indicated that no falls prevention programs were offered by their organization during 2012, when there were in fact programs offered. In this case, the director would not designate an individual to complete the Coordinators’ survey, and if a program had been offered, it would not have been documented by this survey. Nonetheless, conflict in information provided by directors and coordinators was relatively rare, and thus, we assume that error in collected data was infrequent.We asked a series of questions related specifically to the last EB program offered. This served as a cross-sectional sample of the characteristics of all documented EB programs, without having to collect data on all programs. Although the last programs might differ in some respects with the preceding programs, we believe that the characteristics described below generally represent the characteristics of the EB programs we inventoried.For the last EB program delivered in 2012, the Coordinators’ survey asked about (1) the number of participants enrolled in the program, (2) the number of participants completing 80 % of the program, (3) whether the programs were led by lay people or human services professionals. , (4) whether facilitators had received training for the programs they led, (5) the professional background of the facilitators, (6) information about how the program was funded, and (7) whether fees were charged for program participation.Qualtrics™ online survey software was used to develop and deliver both the Directors’ and Coordinators’ surveys.Our data are descriptive. Much of it is aggregated across organizational categories. When relevant, however, some data are presented by organizational categories. The number of older adults served was calculated by averaging the reported number of participants for the last programs and multiplying this by the overall number of EB programs reported by responding organizations.At the conclusion of the survey for each category of the organization, we prepared a report for the DPH and MFPC and sent this organization specific report to the directors of all surveyed organizations in the category.The study was reviewed by the Institutional Review Board at Boston Medical Center.For each category of organization surveyed, there were two response rates: the rate for the Directors’ survey and the rate for the Coordinators’ survey. For the Directors’ survey, response rates varied across organization categories from 25 to 90 %; for the Coordinators’ survey, response rates varied from 67 to 100 %. The overall response rate was 55 % (457/825) for the Directors’ survey and 86 % (128/148) for the Coordinators’ survey. Figure AAA/ASAPs had the largest proportion (52 %) of organizations offering falls prevention programs in 2012, followed by COAs (43 %), ALRs (33 %), YMCAs (18 %), CAAs (17 %), and HHAs (12 %). None of the responding CHCs indicated that they had offered falls prevention programs. Overall, 32 % (148/457) of responding organizations reported offering falls prevention programming (EB or not) in 2012.ALRs had the largest proportion (79 %) indicating intentions to offer falls prevention programming during the years 2013–2014, followed by AAA/ASAPs (77 %), COAs (71 %), HHAs (61 %), YMCAs (45 %), CAAs (40 %), and CHCs (33 %). Overall, the number of organizations indicating intention to offer programs was double (310/148) the number that had actually offered programs during the 2012 baseline year.Salience of falls prevention was highest among the directors of HHAs; HHA directors had a mean score of 4.46 on the salience scale, followed by directors of ALRs (4.26), COAs (3.82), AAA/ASAPs (3.55), YMCAs (3.44), CHCs (2.64), and CAAs (1.33). The weighted average of the salience rating for all responding directors was 3.68, on a scale of 1–5.Overall, 12 % (53/457) of the organizations responding to our survey indicated that they had offered at least one EB falls prevention program during the index year 2012.Of the 107 EB programs we documented, 37 % (40/107) were conducted by AAA/ASAPs, 46 % (50/107) by COAs, 11 % (12/107) by home health agencies, 5 % (5/107) by ALRs, and 1 % (1/107) by a YMCA. CHCs and Community Action Agencies provided no evidence-based programs.Most of these programs were offered in the eastern portion of the state, with the greatest density in the Boston metro area.Of the 53 last EB falls prevention programs offered by the organizations we surveyed, 90 % (47/53) were A Matter of Balance  of the EB programs offered. For the 2012 index year, Home Health Agencies and ALRs had the highest average completion rate (100 %), followed by COAs (88 %), YMCAs (85 %), and AAA/ASAPS (85 %).Of the 53 last EB programs, information about facilitator training was provided for 81 % (43/53). Eighty-eight percent (41/43) of the falls prevention programs offered had at least one trained facilitator delivering the program.Of the 53 last EB programs, information about facilitator’s professional backgrounds was provided for 81 % (43/53). Forty-two percent (18/43) of the programs were facilitated by human services providers and 58 % (25/43) were facilitated by lay people.Of the 18 facilitators with backgrounds as human services providers, 39 % (7/18) were RNs. Physical Therapists and Social Workers made up 16 % (3/18) each. Case Managers, Education Specialists, Occupational Therapists, Personal Trainers, Health Promotions Managers, and Mental Health Counselors and other made up 6 % (1/18) each.Of the 53 last EB programs, information on funding was provided for 81 % (43/53). Forty-four percent (19/43) of these programs were funded internally, 26 % (11/43) were funded externally, and 30 % (13/43) were funded by both internal and external funds.Of the 53 last EB programs, information about fees charged to program participants was provided for 79 % (42/53). Eighty-one percent (34/42) indicated that they did not charge a fee for their falls prevention programs while 19 % (8/42) did.Organizations established to serve older adults have taken the lead in providing EB community falls prevention programs. Specifically, AAAs, ASAPs, and COAs, all part of the service network funded by the Federal and State offices on aging, provided the majority of programs. Falls prevention programs are natural complements for elder services organizations, many of which already provide chronic disease self-care management programs, senior centers, transportation services, exercise programs, meals on wheels, and other support activities. Also, driving the dissemination of falls prevention programs is the fact that, increasingly, public agencies funding services for older adults are requiring that a proportion of these services be EB. Since several falls prevention programs are EB, conducting these programs helps local agencies meet funding criteria.The most widely offered program by far was A Matter of Balance (MOB) , the per participant cost of MOB or Tai Chi could be relatively low. This has implications for the development of statewide falls prevention infrastructure, because it increases the likelihood that health insurers may eventually reimburse for these programs.Also of note was our finding that completion rates for falls prevention programs were high, indicating that older adults value and/or enjoy participating in these programs, thus enhancing program effectiveness  and increasing demand for program deployment. However, thus far most participants have been self-selected. There is little or no data on uptake and completion rates among patients who are referred to falls prevention programs by their physicians.http://www.cdc.gov/STEADI) and reimbursement for falls risk assessment as part of the annual wellness visit reimbursed by Medicare under the Affordable Care Act. The evidence base for falls prevention strategies continues to grow as more trials are conducted, results published, and findings compiled in literature reviews and meta-analyses. These findings may eventually lead to increased reimbursement for EB community falls prevention programs by public and commercial health insurers.It is likely that the number of community-based falls prevention programs will proliferate in Massachusetts and elsewhere. Our data suggest that for many organizations, the salience of falls prevention is high and the directors of many responding organizations indicated intentions to conduct future falls prevention programs. There is increasing awareness among healthcare providers and the public in general that many community-dwelling older adults can benefit from participation in falls prevention interventions. This trend should result in greater engagement of healthcare providers in falls prevention, which in turn will increase referrals and thus increase demand for community-based falls prevention programs. Healthcare provider awareness and engagement will be accelerated by the availability of instruments for assessing falls risk, such as the CDC’s STEADI toolkit .Some surveyed organizations that provided programs may not have responded to the survey.The directors of some surveyed organizations that provided programs may not have been aware of, or may not have recalled, these programs, in which case a Coordinators’ survey would not have been sent.It is likely that the results provide an incomplete inventory of Massachusetts EB falls prevention programs offered in 2012. The number of programs and the number of program participants are likely undercounted due to several factors:Even if the undercount was on an order of 100 %, the number of older adults served would have been very small relative to the nearly one million Massachusetts residents 65 years or older.Nonetheless, this study has several strengths. Our response rates, while modest for the Directors’ survey, were exceptional for the Coordinators’ survey. The study benefitted from the interest and cooperation of numerous public agencies and private associations representing the various categories of targeted organization. Our two-stage survey strategy allowed us to collect details about programs and their implementation, without compromising response rates.Our results indicate that infrastructure for the dissemination of evidence-based falls prevention programs, while limited, is developing in Massachusetts. Programs were offered throughout the state; the salience of falls prevention was high among directors and CEOs who responded to our survey; and most responding directors expressed intentions to offer future programs. Moreover, this dissemination occurred in the absence of institutionalized funding, organizational mandates, legislative policies, widespread referrals from healthcare providers, and health insurance reimbursement. In other words, for the most part, local organizations at the grass roots level have elected to offer fall prevention programs and market these directly to older adults.


The use of contraception is one of the most cost-effective public health interventions and has the potential to prevent about 30% of maternal and 10% of child deaths in developing countries. Voucher-based initiatives for family planning are an effective and viable means of increasing contraceptive use. In this paper, we present a protocol for a pilot study of a novel incentive, a family planning benefits card (FPBC) program to increase uptake of family planning services among urban poor youth in Uganda while leveraging private sector funding.The study employs both impact and health economic evaluation methods to assess the effect of the FPBC program. We propose a quasi-experimental study design with two separate pre- and post-samples to measure program effectiveness. The main outcome of the impact evaluation is the percentage change in the prevalence of modern contraceptive use and unmet need for contraception. We will also conduct model-based incremental cost-effectiveness and budget impact analyses. The main outcomes of the economic evaluation are the cost per enrolled youth and cost per pregnancy averted, and cost per disability-adjusted life-year (DALY) averted. We will also pilot a corporate social responsibility model of sponsorship for the FPBC program in partnership with local corporations. Budget impact analysis will examine the potential affordability of scaling up the FPBC program and the fiscal implications of this scale up to the corporate social responsibility (CSR) budgets of partner corporations, the government, and the individual taxpayer.In this study, we propose an impact and economic evaluation to establish the proof concept of using a FPBC program to increase uptake of family planning services among urban poor youth in Uganda. The results of this study will present stakeholders in Uganda and internationally with a potentially viable option for corporate-sponsored access to family planning in urban poor communities.MUREC1/7 No. 10/05-17. Registered 19th July 2017. The use of contraception contributes to the achievement of the Sustainable Development Goals (SDGs) by reducing the number of unplanned births and reducing maternal and child mortality. In low- income countries, the poor state of public health services and the multiple for-profit private providers mean that the cost remains a significant barrier to access to family planning services. The Government of Uganda is working towards achieving the family planning 2020 goals by closing down contraceptive use gaps but budget constraints remain a major impediment to these efforts. This paper presents an incentive-based family planning benefits card (FPBC) program to increase uptake of family planning services among urban poor youth in Uganda while leveraging private sector funding.The protocol describes the health and economic evaluation processes that will be used to assess the impact of the FPBC program. The study will recruit youth of age 18-30 years and provide them with a family planning benefits card that will allow them access to modern family planning services in the intervention area. We will carry out household surveys among 670 women of age 18-30 years at 0 and 6 months respectively in both the intervention and control sites. The study will also conduct model-based cost-effectiveness and budget impact analyses. We will pilot test a corporate social responsibility sponsorship for the FPBC program.If this study is successful, we will have provided stakeholders with a potential cost-effective model for increasing uptake of modern contraception in urban poor settings while leveraging on private sector funding.The use of contraception is one of the most cost-effective public health interventions and has the potential to prevent about 30% of maternal and 10% of child deaths in developing countries , 3. ProvIn low-income countries like Uganda, the poor state of public health services and the multiple for profit-private providers mean that cost remains a significant barrier to access to family planning services especially to persons in the lowest wealth quintile who have the highest unmet need for contraception . Other bStudies have demonstrated the potential cost savings of modern contraception relative to the costs incurred by unintended pregnancies in Uganda. Reducing the unmet need for modern contraception would reduce maternal mortality by over 40 % and unplanned births and induced abortions by over 44 % while saving over three dollars for every dollar invested in reducing this unmet need . A cost-The Government of Uganda acknowledges that limited access to family planning services hinders development and disenfranchises poor women and is committed to increasing contraceptive use by ensuring access to family planning services. To achieve this, the government has enlisted different strategies including the provision of integrated family planning services in all health facilities and procurement and distribution of contraceptives to men and women of reproductive age. However, budget constraints are a major impediment to these efforts . TherefoThe concept of using benefits as a vehicle for health care access is not new in Uganda. Companies have, in recent years, provided medical benefits to their employees. Research suggests that provision of medical benefits helped companies retain good employees and improved on their performance and job satisfaction –17. InceIn this paper, we present a protocol for a pilot study of a novel incentive benefits card system to increase uptake of family planning services leveraging the private sector. The proposed incentive system is called the Family Planning Benefits Card (FPBC) program. The FPBC program builds on the success of other voucher programs and is a partnership with hospitals and pharmacies. The FPCB program will target youth in the community using trained community health workers to provide counseling and guidance and recruit participants.Unlike previous demand creation programs whose post-pilot financial sustainability was hinged on public-sector funding, the FPBC program proposes to use corporate social responsibility (CSR) as a form of funding for transition to scale. Corporations by their very nature have different incentives than governments: they are designed to maximize profit. However, many corporations include in their structure various levels of CSR. CSR is a form of corporate self-regulation integrated into the business model . CSR goeA review of the literature suggests that activities related to CSR are rare in healthcare and public health in low-income countries. CSR has been suggested as a means to enhance the sustainability of immunization programs , preventThis paper describes the pilot implementation of a novel incentives-benefits card based model of increasing uptake of family planning in low-income settings. In performing this study, we hypothesize that the FPBC program will increase uptake of modern contraception and reduce the unmet need for contraception among the urban poor youth living in slums. Increased modern contraceptive coverage may lead to the reduction of maternal health-related deaths and consequently significantly reduce health care costs in the country. We also hypothesize that the FPBC program will be highly acceptable in the setting of urban slums. The study further hypothesizes that the FBPC program will be cost-effective from both the societal and payer  perspectives. If this program is cost-effective, we will have provided government and stakeholders with a potential cost-effective model for increasing uptake of modern contraception in urban poor settings. We also anticipate that corporate entities will be willing to commit funds that will pay for, and sustain the FPBC program.To evaluate the effectiveness of the FPBC program in increasing uptake of comprehensive family planning services among urban youth aged 18 to 30 years.To evaluate the acceptability and usability of the FPBC program among the urban youth aged 18 to 30 years.To estimate the cost-effectiveness and potential budget impact of the FPBC program on the taxpayer.To pilot test a corporate social responsibility financing model that will pay for and potentially sustain the FPBC program.This is a one-year pilot project implementation and evaluation study. We are proposing to design a novel incentive benefits card based system that will be used to increase uptake of family planning services. We will partner with a local insurance firm to design and manage the FPBC system. The research team will manage the evaluation of the effectiveness of the program and conduct other stakeholder engagements. In partnership with the local insurance firm and its partner clinics and pharmacies in the intervention area, the FPBC program will provide family planning services to the youth aged 18 to 30 years. We will recruit and train community health workers (CHWs) on the counseling and guidance necessary to recruit and access the family planning services. The CHWs will mobilize, sensitize, and recruit individuals in the community. Each recruited participant will be provided with a benefits card and a list of hospitals and pharmacies where the card can be used. The benefits card will contain the beneficiary’s photograph, names, and a unique identifier. The card will allow beneficiaries access family planning counseling and guidance, long-acting reversible contraception such as implants or intrauterine devices, hormonal contraception such as contraceptive pills, injections and vaginal rings and barrier methods such as condoms and diaphragms. The FPBC program will also provide free testing and care needed to inform the choice of family planning method. These tests will include among others pregnancy counseling and testing, referrals to primary health care providers for health conditions such as high blood pressure or diabetes, HIV counseling and testing, and screening and treatment of sexually transmitted infections. We will exclude permanent contraception, such as vasectomy and tubal ligation from our card benefits since our target group is expected, for the most part, to be interested in delaying as opposed to discontinuing fertility.The study is being implemented in the city slums located in the suburbs of Kampala, Uganda’s capital city. The two city slums have been purposively identified for the pilot. The study sites are Kifumbira slum as an intervention area and Kalerwe slum as a comparator. Kifumbira slum is located northeast of Kampala city in Kampala Central division and neighbors Mulago to the west, Bukoto to the east, Kyebando to the north and Kamwokya to the south. Kalerwe slum is located north of Kampala city in Kawempe division. The two slums have populations that share the socio-demographic characteristics and hence provide a good intervention-comparison pair for the study. The majority of the two slum’s residents fall in the lowest wealth quintile and record the high levels of unmet need for contraception — 42% as compared to the national average of 34% . Studiespilot project implementation, and prospective impact and economic evaluation. The project includes three main complimentary sub-studies: 1) an impact evaluation, 2) an acceptability and usability study, and 3) model-based health economics evaluation.The proposed study is a The impact evaluation will utilize a pre- and post- quasi-experimental study design with a control group. We propose a household quantitative survey both in the intervention and control sites to assess the study outcomes at 1 and 6 months respectively. The impact evaluation study will have two primary outcomes: percentage change in the prevalence of modern contraceptive use and the percentage change in the prevalence of unmet need for contraception by study group. The secondary outcomes will include the percentage change in the knowledge of different methods of family planning, and satisfaction levels with the services provided among the study groups. The household survey shall only be conducted among females that are aged between 18 and 30 years, residents of the study areas, and willing to provide informed consent to participate in the survey , the prevalence of modern contraception is 26% and the prevalence of unmet need for contraception among women in the lowest wealth quintile is 42%. The study’s aim is to cause an increase in the prevalence of modern contraception use by about 10 percentage points by the end of the program. The study utilizes the sample size formula for behavioral studies  stated bWhere:n =sample size.d = design effect.p1 = the prevalence of modern contraception.p2 = projected prevalence at the end of the study, so that (p2 − p1) is the magnitude of change you want to be able to detect.p = (p1 +p2)/2.Zα1 − = the z-score corresponding to desired level of significance.Zβ1 −  = the z-score corresponding to the desired level of power.The Table The survey tool will contain sections on socio-economic and demographic characteristics , reproduction , access to family planning information , history of family planning, current use of modern contraception, desire to stop or delay pregnancy (unmet need), reasons for choosing family planning methods, perceived barriers to family planning access and satisfaction levels with provided services and the FPBC program. Questions on socio-economic and demographic characteristics, reproduction, current use and unmet need for modern contraception will be modified from the 2011 UDHS questionnaires.We will carry out data collection for the house survey at both baseline and end-line using the personal digital assistant (PDA) data collection systems. We propose to use open data toolkit (ODK) for questionnaire design and data collection, and a dedicated server to receive data in real time. The electronic system will have data checks and necessary skips in order to improve data quality. The data from the server will be downloaded in excel format and sent to respective software for further analysis. The analysis will be done using R studio  and STATA version 13.0 .To assess if the control group is as similar as possible to the intervention group in terms of pre-intervention characteristics, we will compare the observed demographic and socioeconomic characteristics by group. Group differences for each variable will be summarized using means and proportions. In the event that the observed baseline characteristics show no similarity, we will use propensity score matching to identify the region of common support and discard observations that are substantially dissimilar in the analysis. The primary analysis of this evaluation is an intention to treat analysis (ITA). The magnitude of change in proportion between the two groups provides a potentially unbiased estimate of the average treatment effect (ATE) of the FPBC program. We will use a two-sample proportion z-test to test the null hypothesis that the two sample proportions are significantly different at six months between the intervention and control groups at 5% level of significance. We will also carry out a difference in difference (DID) analysis to identify the magnitude of change as a result of the program if any.p-values will be reported. All results will be considered statistically significant at a 5% level of significance.We shall conduct a number of secondary analyses. We propose to assess the effect of the intervention on the participant’s change in family planning knowledge and satisfaction with the services using two-sample proportion z tests. Comparisons of proportions of changes in knowledge of different methods of family planning and satisfaction levels by intervention group will be conducted. Binary logistic regression analysis using modern contraception use as the outcome variable and demographic characteristics, satisfaction, and knowledge as explanatory variables will be conducted. Both adjusted and crude odds ratios with their corresponding confidence intervals and Upon finishing the baseline survey, we will embark on the process of mobilizing study participants in the Kifumbira slum to enroll for the FPBC program. The acceptability study will utilize a mixed  methods study. The quantitative part will use data from the recruitment forms (acceptability forms) and the family planning medical records form (usability form), and the qualitative part will use data from the key informant interviews (KIIs) and Focus group discussions (FGDs).This study will approach study participants from their homes and invite them to enroll into the FPBC program. Recruitment will be done by moving from house to house and screening youth for eligibility and willingness to participate into the program. This will be done with the help of CHWs and the study’s trained research assistants. All persons eligible for the study will first be taken through a counseling and guidance session about family planning before enrolling into the program. Only participants; 1) aged between 18 to 30 years, 2) self-reported non-use of contraception methods, 3) for females, not currently pregnant, and 4) willing to provide consent will be considered eligible to receive the FPBC will be selected to participate into the program. We propose to recruit a purposive sample of 300 participants for the family planning benefits card for this pilot. A total of 250 persons will be females and 50 will be males of the same age brackets. This sample is based on resource availability for the study. The inclusion of men will help the study team to test a way of attracting males to embrace contraceptives use.Persons meeting the stated inclusion criteria and accepting to enroll for the FPBC program will be requested to provide passport photograph and their biodata. All recruited members shall then be provided with the FPBC that shall contain their full names and a photograph, and a list of clinics and pharmacies where the FPBC can be used. They will then be guided on how to use this card to visit the selected licensed hospitals and pharmacies to access free family planning services. The FPBC will have unique numbers that shall be used to track the use of the card at the clinics and pharmacies. An updated list of the beneficiaries shall also be provided to the service providers for cross-validation to avoid misuse of the card by the non-beneficiaries. Trained community health workers will continuously visit the enrolled participants and provide them with counseling and guidance.Acceptability will be quantitatively measured by estimating the proportion of eligible participants who accept to enroll into the program. Persons who refuse to join the FPBC program will be probed further to identify reasons for refusal. Quantitative categories for reasons for refusal will be created for analysis purposes.Usability of the FPBC will be measured by the number of times the card beneficiaries visited the service providers to seek care. The data will be disaggregated by the type of method and sex. This data will be generated from the health utilization reports generated from the medical records.Data for the acceptability will be collected with the help of trained research assistants exactly after the baseline. Approached participants will be requested to complete a study recruitment form. This form shall also be completed by those declining to join the program to help the study understand reasons for declining to join the program. The study will also collect usability data using the family planning medical records form that shall be completed at the clinics and pharmacies. Focus group discussions and key informant interviews will also be carried to provide a detailed understanding of the program achievements and challenges. Trained qualitative research assistants shall be used to collect qualitative data.All enrolled participants will complete recruitment form. The recruitment form will capture participant’s demographics and an acceptability question. For those who will accept to enroll into the program, more personal details such as names, phone contacts, and passport photograph will be collected.In partnership with a local insurance firm, we propose to design the FPBC medical records form (FMRF) which will be given to the partner clinics and pharmacies to collect data on clients such as date, benefits card number, purpose of the visit, services received, new or continuing clients, nature of contraceptive supplies given, need for referral and any notes taken on the client. Each provider will be trained on the implementation of this routine medical data collection form and other project activities. These forms shall be completed in triplicate. A copy shall be retained by clinics and pharmacies, and other copies given to the local insurance firm provider and research team. This will make monitoring the card usage by the research team credible. Data from the FMRF will be used to assess the usability of the card services. We will at the end of the study match the usability and acceptability data sets for analysis of the acceptability and usability of the FPBC program.We propose to conduct 15 key informant interviews (KIIs) with the community health workers and health facility workers implementing the program. The KIIs will be conducted at the end of project implementation to identify the implementation challenges, and document successes realized during the study period. The respondents will also be asked to make recommendations to help the team make improvements on the program.We also propose to conduct 6 focus group discussions (FGDs) of 8-10 participants per group in the intervention group at the end of the program. The FGDs will be disaggregated by sex, age, and acceptance of participation in the FPBC program. The FGDs will inform knowledge of youth in slum communities about family planning, their attitudes, practices, and barriers towards family planning, drivers of youth choices towards the use of certain family planning methods, health workers’ perceptions about the program, including its benefits, challenges experienced, and suggestions improvement of the program. Persons that declined to participate in the program will be probed further to identify reasons for refusal.All the data collected from the recruitment forms and FMRF will be coded and double entered in Epidata version 3.1. Consistency checks and cross-validation will be done at data entry to remove discrepancies in the final datasets. The analysis will be done using R studio  and STATA version 13.0  .We will perform descriptive analyses of the demographic characteristics of participants included in the study using means and proportions. Univariate and bivariate analyses will be performed to further characterize the study sample. We will report means and proportions of the different variables such as the mean number of times of the card usage per method, proportions of different contraception methods undergone and will be disaggregated by sex and age group. We will explore the association between different variables and acceptability of FPBC program, usability of the card services and the reasons for declining screening using the chi-square test. Binary logistic regression will also be conducted with acceptability (accepted vs. refused) as the outcome variable. We will also perform poison regression analysis with number of times card used as the outcome variable against the participant’s socio-economic demographic characteristics.Qualitative interviews will be audio recorded and notes will be taken during the interviews. The recordings will be transcribed verbatim and translated into English if the recording is in the local language. Analysis will be done using Atlas Ti software. Different themes will be identified and logged into the analytical frame work and will be used to develop code definitions, code categories and themes. Transcripts will be entered into Atlas Ti scientific software as primary documents and free codes generated based on the codebook while allowing for open coding where new codes emerge. Magnitudes of responses as well as patterns in the data using code frequencies in the codes-primary documents table will be identified. Key themes identified in the discussions will be reported.We propose to conduct a model-based incremental cost-effectiveness analysis (CEA) and budget impact analysis (BIA). We will develop a model of the cost-effectiveness of the FPBC program using Microsoft Excel. The main outcomes of the economic evaluation are the cost per enrolled youth, cost per pregnancy averted and cost per DALY averted. We also propose to perform a static aggregate budget impact analysis (BIA) to examine the potential economic value of scaling up the FPBC program and the fiscal implications of this scale up to the CSR budgets of partner corporations, to the government, and to the individual tax payer of implementing this FPBC program.We will perform a primary micro-costing of FPBC program from the payer’s perspective i.e. include all direct medical and all direct non-medical costs and the modified societal perspective i.e. add indirect costs of lost productivity . The dirThe model of cost-effectiveness will be validated by varying inputs to check if the expected values are logical. We will also set costs and outcomes to 0 separately and check if identical expected values are obtained for the comparators. The baseline analysis will consist of the calculation of the costs, the proportion of participants on family planning by contraception method, and the incremental cost-effectiveness ratios—cost per youth enrolled, and cost per method. Sensitivity analyses will be performed to investigate the impact of parameter uncertainty on payoffs. Empirically derived confidence intervals will be used when available. One-way sensitivity analyses will be performed on all parameter inputs to generate tornado diagrams representing the most influential parameters. Distributions will be assigned to all input parameters and probabilistic sensitivity analysis will be performed using a second-order Monte Carlo simulation. This will enable the generation of a cost-effectiveness acceptability curve to represent the impact of parameter uncertainty on estimates of cost-effectiveness.We will also estimate the aggregate national budget impact as well as the cost per Ugandan taxpayer per year of implementing a possible FPBC program. The BIA will involve the following steps: 1) characterization of the population of Uganda to estimate the potential number of people to be impacted by a possible FPBC program, 2) selection of a time horizon between 1 and 3 years, 3) documenting the current state of family planning nationally, 4) estimating the cost of FPBC program at scale, and 5) presenting budget impacts tailored to different audiences. The main analysis will be the generation of an estimate of the potential annual fiscal implication for the CSR budgets of potential corporate sponsors.The aim of the corporation-sponsored sustainability drive is to pilot test a way for funding a possible FPBC program beyond the immediate pilot program phase. Our vision is that corporate entities, through their CSR budgets, will be willing to fund an effective and cost-effective FPBC program. The first three aims of this study will provide effectiveness and economic efficiency data and the fourth aim will pilot test our idea of corporate partnership. The study will identify corporations with CSR budgets and approach them for potential partnership. The study’s media and publicity team will work with our corporate partners to design a media and community publicity plan to enable their good work to find an audience. We will design different metrics to reward and recognize different corporations depending on the expenditure on the FPBC program. All metrics for recognition will be adjusted based on corporations published book value or market capitalization to incentivize a wide range of small, medium, and large corporations.The study has so far recruited and trained 10 community health workers (CHWs) in the study areas to continuously sensitize the youth on family planning services and the associated benefits. Mapping of the study area to delineate boundaries and compile household lists has been completed. A total of six health facilities have also been enlisted for partnership to provide family planning services. The local medical insurance firm (benefits provider) has also been identified and partnerships discussions finalized.This paper describes the protocol for a pilot project implementation, a quasi-experimental impact evaluation, and economic evaluation of a family planning benefits card program. The impact evaluation will help the research team establish the proof of concept of provision of family planning benefits to poor urban youth in Uganda. The results from the model-based health economic evaluation will provide estimates the economic value provided by the program. The potential budget impact analysis of the program will provide estimates of the affordability and potential fiscal impact to multiple stake holders of the program.The proposed study will assess the impact of a family planning benefits card on uptake of modern contraceptives targeting the urban poor with the highest unmet need for contraceptives and that are unable to afford these services. We hypothesize that this program will be highly acceptable and has the potential to reduce unintended pregnancies by over 50% in the study area over the one-year project period. Unlike other programs whose post-pilot financial sustainability is hinged on public sector funding, this study is proposing to use corporate social responsibility financing as a form of funding on the transition to scale. We anticipate that if the program is effective and efficient, corporate companies through their CSR budgets would be willing to support it.If the proposed study is successful, we will have presented to the stakeholders in Uganda, and internationally with a potentially viable option for a corporate-sponsored benefits system to increase uptake of family planning in urban poor communities. The FBBC program might also expand the services coverage to include all sexual and reproductive health services and scale up the program to all the country’s urban slums, refugee camps, and fishing communities that record high levels of poverty and unmet need for contraception.Our study protocol employs rigorous evaluation methods to measure the effect of the FPBC program. The study proposes to use a quasi-experimental study design with a separate pre and post survey sample in each study group. This design will make it possible for the study to test causal hypotheses and detect any differences arising out of the program..The study is limited to only youth aged 18 to 30 years living in urban slums. As a result, the study’s findings may not be generalizable to other groups of women, and in other study settings. Also, quasi-experimental designs by definition lack random assignment. This characteristic comes with challenges of confounding variables that pose threats to the study’s internal validity.In this paper, we describe planned impact and economic evaluation methods to assess a family planning benefits program to increase uptake of family planning services among the urban youth aged 18 to 30 years in poor urban areas in Uganda. The study will establish the proof concept of using the benefits program to increase uptake of family planning services. The study will also asses the efficiency and potential affordability of the program to different stake holders. The final part of the study will assess the feasibility of using corporate social responsibility financing as a form of transition to scale of the program.


This study attempted to examine the changes and related factors in discharged chronic mental patients attending a psychiatric rehabilitation program in Hong Kong adopting a self-help group (SHG) approach with holistic care emphases on the physical, psychological, social, and spiritual functioning of the program participants. A quasi-experimental design involving an experimental group (109 participants attending the program) and a control group (154 patients from a psychiatric outpatient clinic who had never attended any SHG before) was adopted with the participants responding to measures assessing their functioning in the physical, psychological, social, and spiritual domains. Results showed that those who joined the SHG with holistic care elements had more friends and more social satisfaction than the control subjects. Duration of attendance, religious involvement, and group involvement were three key factors related to the outcomes of the program participants. This pioneering study provides support for the effective use of the SHG approach with holistic care elements to help discharged chronic mental patients in the Chinese culture.