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We present the results of the user studies of the CareMe prototype telecare service for supporting older adults with remote telecare services. The CareMe solution targets older adults who are capable of living independently and outside of a dedicated medical institution or a nursing home, but require occasional medical attention, and formal or informal care. The studies were conducted between November 2013 and March 2014 and followed the participatory design approach. The research questions focused on understanding the difference in the participatory design approach when older adults use paper prototypes vs interactive prototypes, and the difference when older adults use interactive prototypes with poor interface design vs interactive prototypes with rich interface design. In total, 45 older adults living in Slovenia participated in the field trial. They were retired, 32 of whom were nursing home residents and 13 were living independently at home. The study sample's age distribution was between 64 and 91 years. The analysis of the filed trial results indicated the importance of the factors that influence users' decision about how and when they use new technology, i.e., the perceived usefulness and the perceived ease-of-use. Main insights gained from the studies show, that it is very difficult to keep older people focused on the topics of discussion and that they have often difficulties to clearly present/express their ideas. Furthermore, abstract concepts, such as paper only prototypes proved to be challenging to cope with, whereas using real applications and services when trying out scenarios using interactive prototypes provided much better experience and feedback. [ABSTRACT FROM AUTHOR]

This scoping review provides an overview of cancer interventions implemented with Arab Americans across the cancer control continuum, including an examination of outcomes and implementation processes. The search strategy included database searching and reviewing reference lists and forward citations to identify articles describing interventions with Arab adults living in the US, with no restrictions on date of publication or research methodology. The review included 23 papers describing 12 unique cancer interventions. Most interventions focused on individual-level determinants of breast and cervical cancer screening; used non-quasi-experimental research designs to evaluate intervention effectiveness; and demonstrated improvements in short-term cancer screening knowledge. Implementation processes were less commonly described. Most interventions were culturally and linguistically tailored to communities of focus; were delivered in educational sessions in community settings; engaged with the community mostly for recruitment and implementation; and were funded by foundation grants. Suggestions for research and intervention development are discussed. [ABSTRACT FROM AUTHOR]

Purpose: Maternal substance use and deaths due to overdoses are increasing nationwide. Evidence suggests that the rate of resumed substance use, and fatal and non-fatal overdose is greatest in the first year after birth, particularly around six months postpartum, compared to other parts of the perinatal period. Doula care has been linked to improvements in perinatal health and outcomes. Description: In response to the opioid epidemic, the Philadelphia Department of Public Health developed and implemented the Doula Support Program (DSP), with a focus on one year of postpartum care for birthing people with a substance use disorder (SUD). In this paper, we describe the program and its formation and report on the early challenges and successes of the program implementation, based on information we received from program founders and managers in a group interview. Assessment: Early successes of the program include partnering with local community-based programs to recruit and retain doulas, supplementing traditional doula education with perinatal SUD-specific trainings, and maximizing client referrals by collaborating with local organizations and treatment centers that serve birthing people with SUD. Client retention, however, has proven to be challenging, especially during the COVID-19 pandemic. Conclusion: The DSP continues to grow, and lessons learned will facilitate program improvements. The goal of this paper is to outline the development and launch of the DSP and to act as a model for other state and local health departments interested in providing doula care for birthing people with SUD. Significance: Maternal substance use and fatal overdoses are increasing in Philadelphia, Pennsylvania. In response to this crisis, the Philadelphia Department of Public Health's Division of Maternal, Child and Family Health developed the Doula Support Program (DSP), offering doula care to pregnant people with a current or past SUD history up to one-year postpartum. To our knowledge, this is the only doula program in Pennsylvania offering one-year postpartum support to birthing people affected by SUD. [ABSTRACT FROM AUTHOR]

Public-academic partnership-based program evaluations can generate actionable evidence for policymaking, program design and implementation in improving school-based mental health service delivery. The University of Pennsylvania Center for Mental Health and public behavioral health care agencies in Philadelphia in the United States have evaluated Philadelphia's school mental health programs reimbursable through Medicaid billing since 2008. The variety of evaluations include (1) examining acute mental health service use of children receiving school-based mental health care and Medicaid expenditure, (2) examining children's externalizing and internalizing behaviors to measure school mental health providers' performance, and (3) examining effects of different types of school mental health programs on children's behavioral health functioning, school outcomes, and other out-of-school service use. This paper reports key findings of these evaluations, discusses how programs have been refined based on evaluation results, and shares lessons learned for successful public-academic partnership-based evaluations to promote use of actionable evidence. [ABSTRACT FROM AUTHOR]

Purpose: Cervical cancer disproportionately burdens low-resource populations where access to quality screening services is limited. A greater understanding of sustainable approaches to implement cervical cancer screening services is needed.Methods: We conducted a systematized literature review of evaluations from cervical cancer screening programs implemented in resource-limited settings globally that included a formal evaluation and intention of program sustainment over time. We categorized the included studies using the continuum of implementation research framework which categorizes studies progressively from "implementation light" to more implementation intensive.Results: Fifty-one of 13,330 initially identified papers were reviewed with most study sites in low-resource settings of middle-income countries (94.1%) ,while 9.8% were in low-income countries. Across all studies, visual inspection of the cervix with acetic acid (58.8%) was the most prevalent screening method followed by cytology testing (39.2%). Demand-side (client and community) considerations were reported in 86.3% of the articles, while 68.6% focused scientific inquiry on the supply side (health service). Eighteen articles (35.3%) were categorized as "Informing Scale-up" along the continuum of implementation research.Conclusions: The number of cervical cancer screening implementation reports is limited globally, especially in low-income countries. The 18 papers we classified as Informing Scale-up provide critical insights for developing programs relevant to implementation outcomes. We recommend that program managers report lessons learnt to build collective implementation knowledge for cervical cancer screening services, globally. [ABSTRACT FROM AUTHOR]

Researchers are often faced with evaluating the effect of a policy or program that was simultaneously initiated across an entire population of units at a single point in time, and its effects over the targeted population can manifest at any time period afterwards. In the presence of data measured over time, Bayesian time series models have been used to impute what would have happened after the policy was initiated, had the policy not taken place, in order to estimate causal effects. However, the considerations regarding the definition of the target estimands, the underlying assumptions, the plausibility of such assumptions, and the choice of an appropriate model have not been thoroughly investigated. In this paper, we establish useful estimands for the evaluation of large-scale policies. We discuss that imputation of missing potential outcomes relies on an assumption which, even though untestable, can be partially evaluated using observed data. We illustrate an approach to evaluate this key causal assumption and facilitate model elicitation based on data from the time interval before policy initiation and using classic statistical techniques. As an illustration, we study the Hospital Readmissions Reduction Program (HRRP), a US federal intervention aiming to improve health outcomes for patients with pneumonia, acute myocardial infraction, or congestive failure admitted to a hospital. We evaluate the effect of the HRRP on population mortality among the elderly across the US and in four geographic subregions, and at different time windows. We find that the HRRP increased mortality from pneumonia and acute myocardial infraction across at least one geographical region and time horizon, and is likely to have had a detrimental effect on public health. [ABSTRACT FROM AUTHOR]

Aim: Sexually transmitted diseases (STD) are one of the most common infections worldwide. The current study aimed to determine what the current STD prevention programs are and their effectiveness. Subject and methods: A systematic review of the literature was done for a period of 10 years (2009–2019) in two databases (PubMed and Cochrane) based on PICO strategy. Inclusion criteria were articles published in the English language only, involving clinical trials with control groups. In order to determine the quality of studies, two reviewers reviewed all qualifying papers independently. Twelve studies met our inclusion criteria. Results: Five of the studies were about tenofovir effectiveness, followed by three about community-based intervention, two regarding vaginal gel effectiveness and two about school-based intervention. The two studies on vaginal gel concluded no effectiveness. Conclusion: As a conclusion, community-based prevention programs targeting adolescent and tenofovir gel showed promising results but more studies and at different locations in the world are needed so that some recommendations can be made in the future. [ABSTRACT FROM AUTHOR]

Mental health challenges have been recognized as one of the most prevalent issues impacting children and families within the United States. Children and families of color are disproportionately affected by this due to lack of access to preventative and ongoing supports, and programs that can help address their overall well-being. These issues are even more severe for those that are at risk or interact with the child welfare system. Social workers use various clinical modalities to assess and support them. In the recent years, child welfare agencies have turned to Evidence based programs (EBPs) as a best practice to meet the needs of children and families. The Title IV-E Prevention Services Clearinghouse, established by the Administration of Children and Families is a landmark effort to review and promote such EBP's that prevents foster care placements, including mental health programs. While the Clearinghouse has reviewed 141 programs and services, out of which 71 have been rated as promising, supported, or well-supported, there is a dearth of culturally responsive programs that have met the Clearinghouse criteria. Given the overrepresentation of African American and Native American Families in the child welfare system, and the critical role of the Clearinghouse in reviewing and promoting EBPs, this paper highlights the philosophical, administrative, cultural and logistical barriers for culturally relevant programs to be accepted into the Clearinghouse. It also provides specific recommendations on how the Clearinghouse and researchers can build EBPs that account for the intersection between mental health, social location and cultural identities of the children and families that social workers serve. [ABSTRACT FROM AUTHOR]

The impact of adverse childhood experiences (ACEs) is well documented and poses challenges for all those living and working with children who have experienced early adversity. The need to be trauma-informed when working with children in all educational settings is now recognised as essential if healing and learning are to take place. There are an increasing number of trauma-informed approaches available, but empirical evidence that supports their efficacy, particularly in the early years of education, is currently scarce. This paper presents the findings of a small-scale study which explored early childhood professionals' perceptions of the effectiveness and sustainability of one trauma-informed approach, Trust Based Relational Intervention (TBRI®). Used widely across the US and Europe, TBRI® is relatively new to Australia and was trialled for the first time in this Tasmanian study. Substance Abuse and Mental Health Services Administration's (SAMHSA, 2014) concept of trauma and guidance for a trauma-informed approach was used to provide a theoretical framework. Online surveys were used to gather data after each professional learning workshop and three and six-months later. Participants reported several positives of TBRI®, including self-development and improved outcomes for children. Whilst challenges/barriers to using the approach were noted, many related to contextual issues rather than to TBRI® specifically. Findings also showed that equipping families with a similar skill set would be advantageous and integral to effecting sustainable change. [ABSTRACT FROM AUTHOR]

Religion and spirituality are an important part of the human experience for many of our clients. Clients often turn to their religion or spirituality as one of their first resources when faced with significant stressors; however, therapists often feel ill-equipped when spiritual or religious content is discussed in therapy. The efforts of clinicians to ethically and competently address spirituality and religion with clients hinges on the work of supervisors and faculty members of Couple, Marriage, and Family Therapy programs. This paper seeks to explain how the supervision process can help therapists overcome the barriers they face when attempting to integrate spirituality and religion into session. A case vignette is presented where a supervisor and supervisee use an Internal Family Systems lens to consult about a case where religious concerns are present. Utilizing IFS, we believe that therapists can better acknowledge their spiritual or religious biases and begin to consider how religion and spirituality can be respected as a diverse part of clients. [ABSTRACT FROM AUTHOR]

In Uganda, low resources for mental health provision combine with disadvantage and inadequate supports for family and community-based care. Catalysed by the need to reduce overcrowded psychiatric hospital wards and frequent readmissions at Butabika National Referral Mental Hospital (BNRMH) in Kampala, the nongovernment organisation YouBelong Uganda (YBU) developed the YouBelong Home (YBH) intervention. YBH is a theoretically eclectic pre and post hospital discharge intervention. This paper reports on qualitative findings of the project Curtailing Hospital Readmissions for Patients with Severe Mental Illness in Africa (CHaRISMA), which explored how to refine the YBH intervention. The project was funded by a UK Joint Global Health Trials (JGHT) Development Grant. Data was collected through structured interviews with service users and caregivers, reflective practice by the YBH implementing team and a stakeholder focus group. A summary of refinements to the YBH intervention follows the TIDieR format (Template for Intervention Description and Replication). [ABSTRACT FROM AUTHOR]

There is increasing interest in working at the intersections of intimate partner violence (IPV) and violence against children (VAC), especially in the family, yet few programmatic strategies exist or have been evaluated to assess the combined impact of strategies on both types of violence. This paper addresses this gap by exploring the influence that Indashyikirwa—a programme designed to reduce IPV in Rwanda— had on VAC in the families of couples participating in the programme. Indashyikirwa included a 21-session couples' curriculum, safe spaces for IPV survivors, and community activism against violence. In addition to reductions in IPV, a randomized control trial found significant reductions in parent's reports of children witnessing IPV, parents' attitudes condoning harsh physical punishment of children, and parents' use of corporal punishment as discipline. This paper uses qualitative data to better understand how and why the couples' curriculum influenced parenting and VAC. Twenty-eight participants (fourteen male-female couples) were individually interviewed at three time points, once before and twice after the couples' curriculum implementation. Six men and six women who completed the curriculum and subsequently carried out activism were also interviewed at two time points. The data were analyzed thematically. Pathways motivating couples' attitude and behavior changes towards children included reflecting on the consequences of IPV for children and appreciating the benefits for children of non-violent, gender equitable households. This analysis suggests that working with co-habiting couples presents a viable strategy for working to prevent IPV, VAC and promote more gender equitable family dynamics. [ABSTRACT FROM AUTHOR]

Objectives: The South Carolina Pregnancy Assistance Fund (SCPAF) funded four counties to increase the amount, quality, and awareness of services for young parents; increase educational attainment among expectant and parenting youth; reduce the number of repeat teen pregnancies among youth; and improve parenting skills. The purpose of this paper is twofold: (1) to describe our application of the Ripple Effect Mapping (REM) technique as an innovative evaluation strategy to gather perspectives from SCPAF stakeholders and (2) to share key findings generated by participants in REM sessions on the perceived success of local SCPAF community collaboratives. Methods: REM, an innovative evaluation strategy, was used to gather perspectives from SCPAF stakeholders. Five REM sessions were conducted with 52 participants. REM sessions included partner interviews and collective development of visual maps to illustrate stakeholder perspectives of program successes. Visual maps, as well as transcripts of discussions, were analyzed using an inductive approach. Results: Stakeholders reported that the connections to resources, supports, and services provided through SCPAF had the potential to alter the life trajectories of expectant and parenting teens (EPT). Stakeholders also described that SCPAF fostered growth in collaboration among partners and reduced duplication of services in funded communities Conclusions for Practice: This paper describes how an innovative evaluation strategy was used to provide a space for stakeholders to dialogue, synthesize their experiences, and construct a collective narrative of key program successes. This paper also illustrates how such approaches can be applied to complex community initiatives. [ABSTRACT FROM AUTHOR]

Intimate partner and sexual violence (IPV and SV) remain significant public health problems for young women and men, and both IPV and SV have short and long-term psychological and physical health impacts for all. Through consistent direction and support from Centers for Disease Control's National Center for Injury Prevention and Control (NCIPC), IPV/SV violence prevention research has shown its potential to prevent these forms of violence. This change is highly significant; many did not believe it was possible to prevent rape and intimate partner violence. In recognition of this emerging field of study, the 2013 Campus Sexual Violence Elimination Act required US public colleges to provide bystander-based training to reduce sexual violence, yet no requirement for evaluation of this recommendation was included in this law. Further, while bystander approaches are recognized as "promising prevention strategies" by the 2014 White House Task Force to Protect Students from Sexual Assault, few rigorous and sufficiently powered studies evaluate the efficacy of bystander programs to reduce violence victimization and perpetration at college and community levels. The papers in this special issue catalogue methods, measures, and outcomes to guide successful implementation and investigations of bystander prevention programs, considering demographic and situational contexts that have traditionally been understudied. Lessons learned from these investigations provide a roadmap of strategies to guide the next generation of researchers, program developers, and policymakers toward effective interpersonal violence prevention. [ABSTRACT FROM AUTHOR]

Thanks to advances in care, most children with congenital heart disease nowadays survive into adulthood. The majority of patients remain at high risk for future complications. Hence, life-long follow-up is mandatory. Care needs of patients evolve, especially when reaching adulthood. A structured transition period to adult care is advocated. Currently, a fully detailed and structured transition program is not available for patients with congenital heart disease. The aim is to describe the development and design of a multicomponent transition program for adolescents with congenital heart disease, called "Transition with a heart." Transition with a heart was developed based on the Dutch program "On your own feet," starting at the age of 12 years and continuing after transfer. The most vital core components include a general and individualized flowchart, adolescent-centered communication, a joined transfer consultation, and an appointed transition coordinator. Adolescents are gradually informed about their condition and potential late consequences in adult life and stimulated to take medical care in their own hands.Conclusion: Transition with a heart is a practical, multicomponent, comprehensive transition program developed to cover the essential aspects of transitional care for adolescents with congenital heart disease (i.e., continuity of care, disease knowledge, and self-management skills). Interventions were selected from the highest sources of scientific evidence currently available.Clinical trial registration: Not applicableWhat is Known:• Transition towards adult life and health care is a complex process, requiring careful patients' guidance. Various task forces have described the need and potential benefits of transition programs in young people with chronic conditions. Details about the practical development and content of such programs in congenital heart disease are, however, currently lacking.What is New:• This method paper presents the development and design of a person-centered multicomponent transition program for adolescents with congenital heart disease comprising interventional components covering the most important aspects of transitional care: promoting autonomy, disease knowledge, and continuity of care. [ABSTRACT FROM AUTHOR]

The efficacy of short-term cancer research educational programs in meeting its immediate goals and long-term cancer research career objectives has not been well studied. The purpose of this report is to describe the immediate impact on, and the long-term career outcomes of, 499 medical students and graduate students who completed the Cancer Research Experiences for Students (CaRES) program at the University of Alabama at Birmingham (UAB) from 1999 to 2013. In summer 2014, all 499 program alumni were located and 96.4 % (481 of 499) agreed to complete a longitudinal tracking survey. About 23 % of CaRES alumni (110 of 499) have published at least one cancer-related paper. Overall 238 cancer-related papers have been published by CaRES alumni, one third of this number being first-authored publications. Nearly 15 % (71 of 481 respondents) reported that their current professional activities include cancer research, primarily clinical research and outcomes research. Of these 71 individuals, 27 (38 %) have completed their training and 44 (62 %) remain in training. Of all respondents, 58 % reported that they administered care to cancer patients and 30 % reported other cancer-related professional responsibilities such as working with a health department or community group on cancer control activities. Of the 410 respondents not currently engaged in cancer research, 118 (29 %) stated intentions to conduct cancer research in the next few years. Nearly all respondents (99.6 %) recommended CaRES to today's students. Challenging short-term educational cancer research programs for medical students and graduate health professional students can help them refine and solidify their career plans, with many program alumni choosing cancer research careers. [ABSTRACT FROM AUTHOR]

Objectives: With the rapid development and spread of information technology, mobile healthcare (M-healthcare) is emerging as a feasible option for improved monitoring and treatment of patients with chronic diseases such as diabetes, particularly for those with limited access to medical institutions. Our study group has developed and evaluated an M-healthcare system that provides remote guidance for diabetic patients. This paper introduces the diabetic M-healthcare system and describes progress in implementation for remote and mobile healthcare in China. We provide evidence that this system improves diabetic patient management and can contribute to the establishment of a new model for patient-centered mobile healthcare. Target audience: The main groups that this paper is aimed at are doctors, nurses, nutritionists, and sportspersons engaged in the design of mobile medical systems, and computer engineers involved in the construction of intelligent medical software systems. Scope: The present article has as its scope designing the M-healthcare clinical follow-up system, identifying the advantages that the M-healthcare system has in comparison with traditional medical treatment, the clinical application effect of the M-healthcare system, and the development status of remote/mobile medical research in China and abroad. [ABSTRACT FROM AUTHOR]

In the United States, adults from marginalized communities experience disproportionate barriers to healthcare which can have a profound impact on overall health and well-being. This phenomenon is especially true for those within the African American, Latinx, and Native American communities. These barriers include Social Determinants of Health (SDOH) which refer to environmental conditions including economic stability, access to quality education, access to quality healthcare, access to quality housing, and community resources that profoundly impact health. One way to address healthcare barriers is to provide Home-Based Primary Care (HBPC) which brings care to individuals with complex healthcare needs where they are most comfortable. Despite the importance, many HBPC teams do not include social work services. Patients may benefit when these services are offered because social workers are experts in social care and work with adults with complex healthcare needs to address SDOH. In this paper, we discuss RUSH@Home which is one HBPC program where social work plays a critical role in patient care. [ABSTRACT FROM AUTHOR]

Family-centered care (FCC) is widely established as the standard professional practice model in pediatric hospital settings (Arabiat, D., Whitehead, L., Foster, M., Shields, L., & Harris, L. (2018). Parents' experiences of family centred care practices. Journal of Pediatric Nursing, 42, 39–44. https://doi.org/10.1016/j.pedn.2018.06.012; Espe-Sherwindt, M. (2008). Family-centred practice: Collaboration, competency and evidence. Support for Learning, 23(3), 136–143. https://doi.org/10.1111/j.1467-9604.2008.00384.x). It embraces social work values that promote self-determination and family empowerment by positioning family members as partners in healthcare treatment, delivery, and decision-making (Kuo, D. Z., Houtrow, A. J., Arango, P., Kuhlthau, K. A., Simmons, J. M., & Neff, J. M. (2012). Family-centered care: Current applica?tions and future directions in pediatric health care. Maternal and Child Health Journal, 16(2), 297–305. https://doi.org/10.1007/s10995-011-0751-7). To promote and advance FCC principles, healthcare organizations collaborate with patients and families as lived experience volunteers, or family leaders, to ensure program design and education reflect users' perspectives and experiences. Despite evidence for its efficacy and uptake (Arabiat, D., Whitehead, L., Foster, M., Shields, L., & Harris, L. (2018). Parents' experiences of family centred care practices. Journal of Pediatric Nursing, 42, 39–44. https://doi.org/10.1016/j.pedn.2018.06.012), translating FCC principles into practice can be challenging (McCarthy, E., & Guerin, S. (2022). Family-centred care in early intervention: A systematic review of the processes and out?comes of family-centred care and impacting factors. Child: Care Health and Development, 48(1), 1–32. https://doi.org/10.1111/cch.12901). In this paper, we introduce an innovative training program for family leaders that embodies the core principles of FCC. The training program was developed in collaboration with families, healthcare and higher education stakeholders, and engagement specialists by a social worker in a pediatric rehabilitation setting in Toronto, Ontario. The program prepares family leaders to engage in teaching and facilitation roles in healthcare education. The Teaching and Facilitation Course for Family as Faculty is the first program of its kind in Canada and was recently recognized by the Health Standards Organization of Canada as a leading practice in healthcare. Since launching in 2019, over 50 participants connected with healthcare organizations across Ontario have completed the course. Graduates have partnered with educators in designing and facilitating over 85 initiatives and workshops across healthcare and academic institutions. The outcomes of a utilization-focused program evaluation, including the strengths and lessons learned are discussed. [ABSTRACT FROM AUTHOR]

Objectives: To describe how the UNC Horizons program, a comprehensive women-centered program for pregnant and parenting women with substance use disorders, and its patient population have changed over time and summarize basic neonatal outcomes for infants born to women in treatment at Horizons. Methods: Yearly Annual Reports from fiscal years of 1994 to 2017 were abstracted. Patient characteristics and infant outcomes compared to normative North Carolina data were examined. Results: Highlights of findings include: The percentage of women for whom opioids were the primary substance of use increased from 0% in 1995–1996 to 62% in 2016–17, while cocaine decreased from 66 to 12%. Intravenous substance use history increased from 7% in 1994–1995 to 41% in 2016–2017. The number of women reporting a history of incarceration rose from 10–20% in the early years to 40%-50% beginning in 2007–2008. The proportion of women reporting a desire to hurt themselves rose from 20% in 2004–2005 to 40% in 2016–2017. Self-reported suicide attempt history remained consistent at 32% across years. While reporting of childhood physical abuse remained at 38% across years, reporting of sexual abuse and domestic violence trended upward. Horizons did not differ from North Carolina in the likelihood of patients giving birth prematurely [χ2(13) = 20.6,p =.082], or the likelihood of a patient giving birth to a low birthweight infant [χ2(13) = 14.7,p =.333]. Conclusions for Practice: Breaking the cycle of addiction for women and children must focus on helping women with substance use problems develop a sense of hope that their lives can improve, and a sense of feeling safe and nurtured. Significance: Systematic examinations of programs that provide treatment services to pregnant and parenting women with substance use disorders have typically been focused on a limited set of outcomes and have been cross-sectional in nature. The current paper presents a detailed examination of the patient populations over a 23-year period, with particular attention to the changes over time in the women served. The birth weight and prematurity of infants born to the women in this program were likewise examined over time, and in comparison to state-level data. [ABSTRACT FROM AUTHOR]

The United States (US) Food and Drug Administration (FDA) Investigational New Drug (IND) Final Rule (US FDA, Final rule: Investigational new drug safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans, 2010) applies to all human drugs and biological products being studied under an IND. The Final Rule specifies that a sponsor must file an IND safety report for any Suspected Unexpected Serious Adverse Reaction (SUSAR) of a medicinal product being investigated. To make a proper SUSAR classification, sponsors need to go beyond conventional Data Monitoring Committees (DMCs) with an interdisciplinary effort, using all relevant data (including data outside clinical trials), to make judgments on the possibility of serious adverse events being caused by the study drug—rather than the underlying condition of the patient or a concomitant therapy. Ball et al. (Ball et al. in Ther Innov Regul Sci 55:705–716, 2021) have reported on how the Final Rule has been implemented by large pharmaceutical companies. This paper explores the experiences of small sponsor companies regarding the Final Rule, to understand the current challenges that they have been facing to meet aggregate IND safety reporting requirements. [ABSTRACT FROM AUTHOR]

Background: Culinary nutrition education programs are increasingly used as a public health intervention for older adults. These programs often integrate nutrition education in addition to interactive cooking workshops or displays to create programs suitable for older adults' needs, ability and behaviour change. Synthesising the existing literature on nutrition education and interactive cooking programs for older adults is important to guide future program development to support healthy ageing. Objectives: To determine the extent of published literature and report the characteristics and outcomes of interactive culinary nutrition education programs for older adults (> 51 years). Design: This scoping review followed the PRISMA-ScR guidelines recommended for reporting and conducting a scoping review. Methods: Five databases were searched of relevant papers published to May 2022 using a structured search strategy. Inclusion criteria included: older adults (≥ 51 years), intervention had both an interactive culinary element and nutrition education and reported dietary outcome. Titles and abstracts were screened by two reviewers, followed by full-text retrieval. Data were charted regarding the characteristics of the program and outcomes assessed. Results: A total of 39 articles met the full inclusion criteria. The majority of these studies (n= 23) were inclusive of a range of age groups where older adults were the majority but did not target older adults exclusively. There were large variations in the design of the programs such as the number of classes (1 to 20), duration of programs (2 weeks to 2 years), session topics, and whether a theoretical model was used or not and which model. All programs were face-to-face (n= 39) with only two programs including alternatives or additional delivery approaches beside face-to-face settings. The most common outcomes assessed were dietary behaviour, dietary intake and anthropometrics. Conclusion: Culinary nutrition education programs provide an environment to improve dietary habits and health literacy of older adults. However, our review found that only a small number of programs were intentionally designed for older adults. This review provides a summary to inform researchers and policy makers on current culinary nutrition education programs for older adults. It also recommends providing face-to-face alternatives that will be accessible to a wider group of older adults with fewer restrictions. [ABSTRACT FROM AUTHOR]

Drawing on research that has identified specific predictors and trajectories of risk for violence and related negative outcomes, a multitude of small- and large-scale preventive interventions for specific risk behaviors have been developed, implemented, and evaluated. One of the principal challenges of these approaches is that a number of separate problem-specific programs targeting different risk areas have emerged. However, as many negative health behaviors such as substance abuse and violence share a multitude of risk factors, many programs target identical risk factors. There are opportunities to understand whether evidence-based programs can be leveraged for potential effects across a spectrum of outcomes and over time. Some recent work has documented longitudinal effects of evidence-based interventions on generalized outcomes. This work has potential for advancing our understanding of the effectiveness of promising and evidence-based prevention strategies. However, conducting longitudinal follow-up of established interventions presents a number of methodological and design challenges. To answer some of these questions, the Centers for Disease Control and Prevention convened a panel of multidisciplinary experts to discuss opportunities to take advantage of evaluations of early prevention programs and evaluating multiple long-term outcomes. This special section of the journal Prevention Science includes a series of papers that begin to address the relevant considerations for conducting longitudinal follow-up evaluation research. This collection of papers is intended to inform our understanding of the challenges and strategies for conducting longitudinal follow-up evaluation research that could be used to drive future research endeavors. [ABSTRACT FROM AUTHOR]

Introduction: The purpose of this paper is to describe the curriculum and self-reported outcomes on measures of interdisciplinary leadership skills for work within the field of developmental disabilities from trainees in one interprofessional training program. Methods: The paper highlights one program's curriculum and strategy for capturing self-report survey measures from trainees in cohorts from 2014–2018 (n = 86) on two surveys (Interdisciplinary Attitudes and Skills and Leadership Self-Evaluation Form) and three time points across the training year: before training (T1), mid-year (T2), and after training (T3). Results: Data from 86 trainees are reported including demographics (nearly 80% white, 92% female), non-descriptive statistics due to non-normative samples, and tertiles demonstrating changes between time points. Significant differences between medians are reported between T1-T3 specifically related to utilizing interdisciplinary skills and gains in leadership competencies. Specific utilization of skills was reported to be 'Greatly' attributable to the LEND program related to sharing ideas and asking for help across disciplines. Discussion: Trainees' self-report from before training to after training indicates an increase in competence and utilization of interdisciplinary skills to be expected from participation in the curriculum. Self-report measures are [ABSTRACT FROM AUTHOR]

Purpose: Long-acting reversible contraception (LARC) is encouraged as a strategy to address racial disparities in birth outcomes. Black woman-led organizations and stakeholders recommend a thoughtful integration of Reproductive Justice for any LARC programs. This paper will describe how one state-funded maternal and child health program reconceptualized an evidence-based strategy (EBS) focused on increasing access to LARC, to a broader strategy that incorporated principles of Reproductive Justice to improve birth outcomes. Description: In 2016, North Carolina established the Improving Community Outcomes for Maternal and Child Health (ICO4MCH) program. As part of this program, five county health departments were awarded funding to "increase access to LARC". Noting community partners' concerns with this strategy, ICO4MCH leadership revised the strategy to focus on using the Reproductive Justice framework to improve utilization of reproductive life planning and access to LARC. Leaders modified the strategy by changing performance measures and scope of work/deliverables required by grantees. Assessment: Using quarterly reports and focus group data from ICO4MCH grantees, we identified key steps communities have taken to prioritize Reproductive Justice. Key findings include that sites hosted Reproductive Justice trainings for team members and changed language describing family planning services. These activities were tailored to fit community context and existing perceptions about reproductive health services. Conclusion: The ICO4MCH program was able to modify a LARC EBS to better emphasize Reproductive Justice. Local agencies desiring to shift their LARC programs should include and value feedback from those with lived experience and partner with organizations committed to Reproductive Justice. [ABSTRACT FROM AUTHOR]

Clearinghouses develop scientific criteria that they then use to vet existing research studies on a program to reach a verdict about how evidence-based it is. This verdict is then recorded on a website in hopes that stakeholders in science, public policy, the media, and even the general public, will consult it. This paper (1) compares the causal design and analysis preferences of 13 clearinghouses that assess the effectiveness of social and behavioral development programs, (2) estimates how consistently these clearinghouses rank the same program, and then (3) uses case studies to probe why their conclusions differ. Most clearinghouses place their highest value on randomized control trials, but they differ in how they treat program implementation, quasi-experiments, and whether their highest program ratings require effects of a given size that independently replicate or that temporally persist. Of the 2525 social and behavioral development programs sampled over clearinghouses, 82% (n = 2069) were rated by a single clearinghouse. Of the 297 programs rated by two clearinghouses, agreement about program effectiveness was obtained for about 55% (n = 164), but the clearinghouses agreed much more on program ineffectiveness than effectiveness. Most of the inconsistency is due to clearinghouses' differences in requiring independently replicated and/or temporally sustained effects. Without scientific consensus about matters like these, "evidence-based" will remain more of an aspiration than achievement in the social and behavioral sciences. [ABSTRACT FROM AUTHOR]

The increasing need for mental health support and a shortage of therapists have led to the development of the eXtended-reality Artificial Intelligence Assistant (XAIA). This platform combines spatial computing, virtual reality (VR), and artificial intelligence (AI) to provide immersive mental health support. Utilizing GPT-4 for AI-driven therapy, XAIA engaged participants with mild-to-moderate anxiety or depression in biophilic VR environments. Speaking with an AI therapy avatar in VR was considered acceptable, helpful, and safe, with participants observed to engage genuinely with the program. However, some still favored human interaction and identified shortcomings with using a digital VR therapist. The study provides initial evidence of the acceptability and safety of AI psychotherapy via spatial computing, warranting further research on technical enhancements and clinical impact. [ABSTRACT FROM AUTHOR]

This paper describes the development and initial chaplaincy user evaluation of 'Pastoral Narrative Disclosure' (PND) as a rehabilitation strategy developed for chaplains to address moral injury among veterans. PND is an empirically informed and integrated intervention comprising eight stages of pastoral counselling, guidance and education that was developed by combining two previously existing therapeutic techniques, namely Litz et al's (2017) 'Adaptive Disclosure' and 'Confessional Practice' (Joob & Kettunen, 2013). The development and results of PND can be categorized into five phases. Phase 1: PND Strategy Formation—based upon extensive international research demonstrating that MI is a complex bio-psycho-social-spiritual syndrome with symptoms sufficiently distinct from post-traumatic stress disorder. The review also provided evidence of the importance of chaplains being involved in moral injury rehabilitation. Phase II: Development and Implementation of 'Moral Injury Skills Training' (MIST)—which involved the majority of available Australian Defence Force (ADF) Chaplains (n = 242/255: 94.9%) completing a basic 'Introduction to Moral Injury' (MIST-1) as well as an 'Introduction to PND' (MIST-2). Phase III: MIST-3-PND-Pilot evaluation—involved a representative chaplaincy cohort (n = 13) undergoing the PND eight-stage strategy to ensure the integrity and quality of PND from a chaplaincy perspective prior to wider implementation. The pilot PND evaluation indicated a favourable satisfaction rating (n = 11/13: 84.6%; M = 4.73/5.0 satisfaction). Phase IV: MIST-3-PND Implementation—involved a larger cohort of ADF Chaplaincy participants (n = 210) completing a revised and finalized PND strategy which was regarded favourably by the majority of ADF Chaplains (n = 201/210: 95.7%; M = 4.73/5.0 satisfaction). Phase V: Summation. In conclusion the positive satisfaction ratings by a significant number of ADF chaplaincy personnel completing MIST-3-PND, provided evidence that chaplains evaluated PND as a suitable counselling, guidance and education strategy, which affirmed its utilisation and justifies further research for using PND to address MI among veterans, that may also prove valuable for other chaplains working in community health and first responder contexts. [ABSTRACT FROM AUTHOR]

The Social Competence Observation Scale (SCOS) is an objective observational measure developed to assess the social performance of children with autism spectrum disorder (ASD). This paper describes development of the SCOS and results of initial testing of reliability and treatment sensitivity for a sample of 12 children, ages 4–6 years, with ASD. Based on observations, the measure can yield three scores including a social impairment severity, change, and responder status score. Results suggested good-to-excellent reliability (inter-observer agreement and test–retest) and the SCOS was treatment sensitive to changes resulting from the intervention (at the social impairment severity score, change score, and responder status levels). Lastly, the effect size based on the SCOS social impairment severity score improvements (baseline-to-post-treatment) for the coders was large and was comparable to parent ratings on a standardized measure of ASD social impairment symptom severity. Implications and suggestions for future study are discussed. [ABSTRACT FROM AUTHOR]

Introduction: The National Maternal and Child Health Workforce Development Center provides training, coaching, and consultation to Title V programs. The flagship experience is the Cohort program, a 6-8-month leadership development program where Title V programs convene a multisector team to address a pre-selected state/jurisdictional challenge related to health systems transformation. The overall objective of this paper is to demonstrate the impact of skills developed via the Cohort program on state/jurisdictional capacities to address complex challenges. Methods: Qualitative, post-Cohort evaluation data were analyzed using inductive and deductive coding and the "Sort and Sift, Think and Shift" method. Themes and supporting text were summarized using episode profiles for each team and subsequently organized using the EvaluLEAD methodology for identifying and documenting impact. Results: Teams brought an array of challenges related to health systems transformation and 94% of teams reported achieving progress on their challenge six-months after the Cohort program. Teams described how the Cohort program improved workforce skills in strategic thinking, systems thinking, adaptive leadership, and communication. Teams also reported the Cohort program contributed to stronger partnerships, improved sustainability of their project, produced mindset shifts, and increased confidence. The Cohort program has also led to improved population health outcomes. Discussion: Through working with the Center, Title V leaders and their teams achieved episodic, developmental, and transformative results through application of Center tools and skills to complex challenges. Investment in the MCH workforce through skill development is critical for achieving transformative results and solving "wicked" public health problems. [ABSTRACT FROM AUTHOR]

Aim: International comparisons of public health measures relative to observed best practice are increasingly important for evaluating community health promotion strategies and policies such as meeting or not meeting public health guidelines. This study aimed to identify methods enabling robust evaluation with such binary effect measures at a population level. Subject and methods: Conventional efficiency comparisons of binary effect proportions are problematic due to a lack of consistency with alternate framing of resulting relative risks. In this paper, we illustrate such inconsistent efficiency measures comparing the proportion of school age children (9–11 years) meeting or not meeting integrated movement guidelines (IMGs) across the 12 countries from the International Study of Childhood Obesity, Lifestyle and the Environment (ISCOLE) study. IMGs jointly consider physical activity, sleep and sedentary behaviours. An odds method is developed to enable consistent efficiency comparison with alternative framing of binary effects. Results: A novel odds solution to relative risk problems arising with conventional efficiency comparison of binary effects with alternative framing is shown to provide consistent efficiency measures relative to best practice. Furthermore, this technical advancement is shown to extend to consistent indirect comparison and evidence translation. Conclusion: Robust methods for international cross-country comparison of binary effect measures such as meeting or not meeting guidelines are identified with a novel odds ratio method. This novel solution is particularly important for health promotion evaluation of IMGs given the need for consistent comparison in evaluating practice evidence of what works now and consistent evidence translation of treatment effects as and when they emerge. [ABSTRACT FROM AUTHOR]

This methods paper describes the fractional factorial design within the context of an evaluation of campus bystander programming. Prior evaluations include relative program comparisons, but do not reflect campus implementation of specific aspects of prevention programming. Campuses use combinations of programs, delivered across modalities, audiences, intensity, and degrees of requirement. Bystander program evaluation, in a natural experiment, must consider combinations of these components. This evaluation offers a novel application of the fractional factorial framework, considering combinations of program components, as implemented, within a multi-campus quasi-experimental design. Leveraging qualitative data, cluster analysis provides an initial identification of bystander program component combinations, mapped to experimental conditions. SAS v9.4 PROC FACTEX constructs possible fractional factorial designs to estimate main effects. From key informant interviews, primary program components are determined: delivery method, level of skill-building, degree of requirement, and intended audience. A total of seven combinations are identified. Using presence or absence of program components, a partial factorial structure is identified, where component clusters comprised seven of the 24 = 16 possible combinations. The smallest number of experimental conditions necessary for estimating these effects is determined with PROC FACTEX. Resulting designs indicate the necessary experimental conditions for determining bystander program component effectiveness available within this study. Our fractional factorial approach offers a novel strategy for planning an evaluation of several bystander program component combinations. This paper provides foundational elements needed to implement a bystander evaluation design, with the requisite emphasis on program components and relevant combinations, while optimizing number of participating campuses. [ABSTRACT FROM AUTHOR]

As mandated by the 2013 Campus Sexual Violence Elimination Act, bystander programs to reduce sexual and intimate partner violence are being adopted in college communities throughout the United States. However, little is currently known about how bystander programs are selected, implemented and experienced by staff and students. In the Multi-College Bystander Efficacy Evaluation (mcBEE) project, we seek to evaluate the relative efficacy of bystander programs at multiple college campuses. In this paper, we describe our mixed methods strategies as a critical first step in achieving our overall goal. We are employing a multi-phase mixed methods triangulation design to gather qualitative and quantitative data on bystander programming and intervention components at 24 college campuses. Specific methods include website reviews of campus programming and staff (Phase 1), web-based key informant surveys (Phase 2), and key informant interviews (Phase 3) over the four-year study period. To date, Phase 1 of data collection is complete and Phases 2 and 3 are ongoing. Survey and key informant interview data will shed light on campus decision-making processes for the adoption of bystander programs and provide program implementation, dose, and fidelity data over time. Data from each phase is being integrated to determine specific bystander intervention components at each campus that will inform analyses measuring relative program efficacy. This paper outlines the protocol and methods for a large-scale evaluation of college-based bystander program efficacy using a multi-phase mixed methods design with multiple forms of data triangulation. [ABSTRACT FROM AUTHOR]

The International Rescue Committee's Life Skills Tailored Package for Early Marriage focuses on engaged, married, and divorced Syrian refugee girls aged 13–18 living in Lebanon. This paper details findings from a qualitative program evaluation. In-depth interviews (IDIs) and focus group discussions (FGDs) explored participants' viewpoints about program components. IDIs engaged program staff and adolescent girls. FGDs included adolescent girls, husbands/fathers, and mothers/mothers-in-law. Data were audio-recorded, transcribed, and assessed using inductive content analysis. Three themes emerged: (1) engaging influencers with discretion facilitated girls' participation, (2) reaching out to vulnerable girls required foresight and flexibility, and (3) participation fostered development of personal resources and adaptive capacities among adolescent girls, who described improvements in self-confidence for decision-making/time management, reproductive health knowledge, emotional regulation/understanding of healthy relationships, and self-protection. Efforts to improve psychosocial and reproductive health of refugee adolescent girls experiencing child marriage should integrate lessons learned through this program. [ABSTRACT FROM AUTHOR]

Faith-based organizations (FBOs) can play an important role in improving health outcomes. Lay community health advisors (CHAs) are integral to these efforts. This paper assesses the sustainability of a CHA training program for congregants in African-American and Latino FBOs and subsequent implementation of educational workshops. The program is unique in that a health care chaplain in an academic medical center was central to the program's development and implementation. Forty-eight CHAs in 11 FBOs were trained to teach workshops on cardiovascular health, mental health, diabetes, and smoking cessation. Two thousand four hundred and forty-four participants attended 70 workshops. This program has the potential to be a model to educate individuals and to address health inequities in underserved communities. Health care chaplains in other medical centers may use this as a model for enhancing community engagement and education. [ABSTRACT FROM AUTHOR]

This literature review presents a critical appraisal of the dominant approaches toward the sexuality and relationships of people with acquired brain injury. In particular, we sought to identify and review existing programs focusing on sexuality and relationships which use an educational and/or peer–peer approach. A systematic and comprehensive search of the EBSCOHOST database was conducted within an unlimited time-frame to yield the highest number of relevant results possible, along with hand-searching of key journals and databases. Reports, papers and webpages, documents commonly referred to as 'grey literature' that are not published in peer-reviewed journals, were also hand searched as a part of this review. The database search yielded 862 results, 14 of which were found to be relevant to our research interests. All of the sexuality education programs identified in this review were experienced positively by participants, families, caregivers, and professionals working with people with acquired brain injury. No peer–peer sexuality and relationships programs were identified. However, we found strong support for the use of peer–peer approaches in other programs for people with acquired brain injury. This literature review provides strong support for the development peer–peer sexuality and relationships programs for people with acquired brain injury. However, any future programs would have to overcome the limitations of existing sexuality and relationships programs. [ABSTRACT FROM AUTHOR]

Military veterans can experience spiritual/religious struggles such as weakening of beliefs, loss of meaning, increased guilt, difficulty forgiving, and moral challenges as a result of military trauma. While mainstream treatments (e.g., exposure therapy) have been shown to be effective for many, they often fail to address these issues adequately. This paper describes an 8-session spiritually-based group intervention designed to treat trauma-related spiritual wounds among military veterans. A program evaluation conducted with 24 veterans revealed significant reductions in PTSD symptoms, spiritual injury, and negative religious coping from pretest to posttest. The findings support the need for additional PTSD treatment approaches. [ABSTRACT FROM AUTHOR]

Treating patients with up-to-date medical knowledge is an ongoing goal for healthcare workers and implies efficient knowledge management at the point of care. Widely available mobile wireless technologies influence practices but a significant gap remains between technological possibilities and actual usage. The purpose of this study was to analyze residents' baseline practices in managing medical knowledge and to evaluate the use and impact of an innovative multiplatform application dedicated to anesthesiology and intensive care residents. This study took place in Rennes Teaching Hospital and comprised two distinct surveys. First, in April 2018, all residents received a ten-items online survey focusing on managing medical knowledge. Then, through a second online survey constituted of ten items, we sought to assess the use of a new multiplatform cloud-based application named "DansMaBlouse", dedicated to sharing and indexing medical knowledge, in anesthesiology and intensive care residents. Among 148 residents that answered the evaluation survey, the most sought out pieces of information in clinical setting were a phone or fax number (74%), drugs' characteristics (68%) and expert guidelines (57%). The main sources were senior staff (68%), medical databases (60%) and an Internet search engine (59%). Computers and smartphones were more frequently used than bound paper notebooks. After implementation of the multiplatform application DansMaBlouse, fifty-nine (82%) of the 72 residents that answered the evaluation survey reported using the application and 39% used it more than ten times. Among application users, 90% found it easy to use and 92% agreed that it improved point-of-care access to knowledge. Accessing appropriate medical knowledge at the point of care remains an issue for residents and can be improved by a multiplatform application combining personal and shared up-to-date resources. [ABSTRACT FROM AUTHOR]

The operative and non-technical skills exposure of urology trainees has reduced due to a number of factors, including the European Working Time Directive, and the COVID-19 pandemic. Simulation-based education (SBE) is an innovative addition to clinical experience which can begin to address the skills-based learning deficiency in order to help trainees meet their curriculum requirements and optimise the exposure required for a trainee to become a competent general urology consultant. Surgical simulation is an effective training tool but has a complex implementation process, requiring considerable planning tailored to specific educational targets, to ensure it is sustainable and reproducible. Methodology from the field of implementation science offers an invaluable approach to design an effective simulation-based training adjunct, as exemplified by the example of the UK Urology Simulation Boot Camp (USBC), a comprehensive training course which incorporates core technical and non-technical skills based on the current Joint Committee on Surgical Training (JCST) urological training curriculum to equip newly appointed urology trainees to work as competent junior registrars. Delivered annually in Leeds since 2015, the course has had excellent feedback and results in improving the urological knowledge of trainees, as well as increases in trainees' confidence. This paper will provide a summary of how the course was designed, delivered, reproduced, sustained and evaluated. Its success is demonstrated by its incorporation into the UK urology training programme, and since 2018, it is now recommended to all new urology residents in the UK. The course implementation model would be applicable to other surgical specialties. [ABSTRACT FROM AUTHOR]

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Background: Mentoring programs pair non-familial adults with children and adolescents for the purposes of promoting positive youth development. Although these programs are widely popular, evaluations tend to show that mentoring programs have, on average, modest effects on youth outcomes. Some researchers have suggested that mentoring programs should homogenize mentoring activities as a means for increasing effect sizes of programs. : Objective: This paper describes why heterogeneity of mentoring activities should not necessarily be regarded as a problem (i.e., a bug) that needs correction; rather it is more representative of the construct of mentoring as it is popularly understood and also desirable because of the potential to improve access and quality of prevention services (i.e., it is a feature). Method: We present different simulated scenarios demonstrating how evaluations of mentoring programs may change the estimates of treatment effects depending on how evaluators measure programmatic activities and approach analyses. Results: Analyses illustrate that commonly used evaluation strategies that treatment effects may be underestimated when mentoring activities are not measured and are paired with common analytic approaches (e.g., intent-to-treat analyses). Simulated scenarios also highlight alternative approaches for defining programmatic elements and evaluating programs to produce a more robust estimate of effects. Conclusions: The optimal strategy for evaluating mentoring services depends on the particular features of the program as well as the goals of the evaluation. One approach researchers might take is to evaluate specific mentoring practices, before evaluating mentoring programs, to begin to understand program impact. [ABSTRACT FROM AUTHOR]

Introduction: The U.S. has the highest rate of preterm birth (PTB), of all developed countries, especially among African American women. Social determinants of health and inequalities in health outcomes are understudied areas. The intersectionality of race and socioeconomic status has been shown to contribute to chronic stress, stress has been shown to be associated with PTB, yet the mechanisms that affect pregnancy outcomes have not been explicit. Mindfulness-based Interventions that address stress reduction during pregnancy may improve quality of life during pregnancy, perhaps enhancing resilience, and be on the pathway to reducing the risk of negative pregnancy outcomes such as PTB. Methods: We over-enrolled African American women and those covered by Medicaid to reach women at higher risk for PTB and included women in substance use treatment. Participants were enrolled in a 6-week mindfulness in pregnancy (MIP) intervention at the obstetric clinic. Sociodemographic characteristics and psychosocial assessments were obtained at three time points. Results: We enrolled 35 women who self-identified as: non-white, Medicaid recipients, aged 25–35 years, with high school or less education. We found reductions in perceived stress, pregnancy specific stress, trait anxiety and depression and increases in mindfulness that sustained post-intervention at 2 and 7 months. Discussion: Social determinants and stress in particular have been associated with negative birth outcomes. This paper describes a brief intervention and results of MIP tailored to women who have significantly more stress due to race, poverty, homelessness, substance use treatment and other comorbid health risks including PTB. [ABSTRACT FROM AUTHOR]

Adolescents impacted by their own or a relative's cancer diagnosis experience significant psychosocial needs. Residential programmes provide opportunities to address these, yet limited evaluation research and unclear reporting of therapeutic and theoretical underpinnings complicate efforts to understand programme effects. This paper reports the development and process evaluation of PEER, a four-day programme with psychosocial (acceptance and commitment therapy, self-compassion) and recreational components for adolescents impacted by their own or a parent/sibling's cancer. Staff (N = 51) and adolescents (N = 148, 12–17 years) who attended a PEER programme participated in this evaluation. The evaluation of fidelity included measures of facilitators' confidence to deliver content, adherence to the programme manual, quality of programme delivery, participants' engagement, and overall satisfaction. The process evaluation included assessment of quality of life, distress, and process variables (psychological flexibility, mindfulness, self-compassion) at pre-programme, post-programme, and two-month follow-up, as well as qualitative feedback from participants and facilitators. Moderation analyses identified predictors of clinically significant improvement in psychosocial outcomes. The programme was delivered with good fidelity, and participants reported high satisfaction and engagement. Approximately 15–20% of participants experienced clinically-meaningful improvements in distress and quality of life; those who reported higher distress and lower baseline psychological flexibility, mindfulness and self-kindness experienced greater improvements. Qualitative feedback additionally evidenced the value of peer connection and support. The evaluation evidences PEER's feasibility, acceptability and value for adolescents impacted by cancer, particularly those experiencing greater distress. Its success indicates the potential of the therapeutic approaches used, and for community organisations to develop interventions complementing services offered by healthcare systems. Highlights: A new programme informed by Acceptance and Commitment Therapy and self-compassion was developed for adolescents impacted by cancer. The programme was delivered with high fidelity, and found to be feasible and acceptable for participating adolescents. 15–20% of participants reported clinically-meaningful improvements in distress and quality of life. Those with higher baseline distress and lower psychological flexibility, mindfulness and self-kindness reported greater benefits. [ABSTRACT FROM AUTHOR]

Purpose During 2009‒2013 a pilot project was carried out in Zurich which aimed to increase the income of disability insurance (DI) benefit recipients in order to reduce their entitlement to DI benefits. The project consisted of placement coaching carried out by a private company that specialized in this field. It was exceptional with respect to three aspects: firstly, it did not include any formal training and/or medical aid; secondly, the coaches did not have the possibility of providing additional financial incentives or sanctioning lack of effort; and thirdly due to performance bonuses, the company not only had incentives to bring the participants into (higher paid) work, but also to keep them there for 52 weeks. This paper estimates the medium-run effects of the pilot project and assesses the net benefit from the Swiss social security system. Methods Different propensity score matching estimators are applied to administrative longitudinal data in order to construct suitable control groups. Results The estimates indicate a reduction in DI benefits and an increase in income even in the medium-run. A simple cost-benefit analysis suggests that the pilot project was a profitable investment for the social security system. Conclusion Given a healthy labor market, it seems possible to enhance the employment prospects of disabled persons with a relatively inexpensive intervention, which does not include any explicit investments in human capital. [ABSTRACT FROM AUTHOR]

PROMs use in primary care has expanded from simply describing patient populations to contributing to decision-making, in response to the increasingly complex, ever-changing healthcare environment. In Alberta, primary care is organized into primary care networks (PCNs), where family physicians are grouped geographically and supported by allied health professionals. PCNs implement programs and services in response to local population health needs with frequent evaluation, often incorporating PROMs for this purpose. As PCN programs and services vary greatly across Alberta, so do their use of PROMs. An area of commonality is the use of the EQ-5D-5L instrument; 29 out of 41 PCNs are registered and licensed to use the instrument. It is often administrated by paper, pre- and post-program, and in combination with other specific measures, depending on the program or target population. Some PCNs share programming and therefore outcome measurement, but often the selection, implementation (including training and administration procedures) and evaluation/reporting of PROMs are unique to the PCN. As well, data analysis is largely dependent on the size and capacity of the PCN. Using PROMs for PCN program evaluation supports clinical understanding and complements clinical outcomes. PROMs describe the population attending a program, as well as provide an element of consistency when examining trends across multiple programs or timepoints. This contributes to inquiries and decisions around program development, components, administrative features, resource allocation and delivery. Challenges of PROMs use in primary care include the absence of cohesive data capture technology. This limits data capabilities and presents difficulties with data fidelity, storage, export, and analysis. Additionally, this real-world application lacks a control arm and presents methodological challenges for comparative research purposes. Furthermore, capturing long term patient outcomes poses administrative challenges of multiple follow ups. More research is required into best reporting mechanisms to ensure the data is used to its full potential. To overcome these challenges, leadership and clinician engagement are key. As well, determining consistent PCN PROM reporting requirements will ensure data are comparable across PCNs and contribute to provincial level evaluations, further supporting the movement towards overall health system quality improvement. [ABSTRACT FROM AUTHOR]

Background: There have been several calls for estimations of costs and consequences of headache interventions to inform European public-health policies. In a previous paper, in the absence of universally accepted methodology, we developed headache-type-specific analytical models to be applied to implementation of structured headache services in Europe as the health-care solution to headache. Here we apply this methodology and present the findings. Methods: Data sources were published evidence and expert opinions, including those from an earlier economic evaluation framework using the WHO-CHOICE model. We used three headache-type-specific analytical models, for migraine, tension-type-headache (TTH) and medication-overuse-headache (MOH). We considered three European Region case studies, from Luxembourg, Russia and Spain to include a range of health-care systems, comparing current (suboptimal) care versus target care (structured services implemented, with provider-training and consumer-education). We made annual and 5-year cost estimates from health-care provider and societal perspectives (2020 figures, euros). We expressed effectiveness as healthy life years (HLYs) gained, and cost-effectiveness as incremental cost-effectiveness-ratios (ICERs; cost to be invested/HLY gained). We applied WHO thresholds for cost-effectiveness. Results: The models demonstrated increased effectiveness, and cost-effectiveness (migraine) or cost saving (TTH, MOH) from the provider perspective over one and 5 years and consistently across the health-care systems and settings. From the societal perspective, we found structured headache services would be economically successful, not only delivering increased effectiveness but also cost saving across headache types and over time. The predicted magnitude of cost saving correlated positively with country wage levels. Lost productivity had a major impact on these estimates, but sensitivity analyses showed the intervention remained cost-effective across all models when we assumed that remedying disability would recover only 20% of lost productivity. Conclusions: This is the first study to propose a health-care solution for headache, in the form of structured headache services, and evaluate it economically in multiple settings. Despite numerous challenges, we demonstrated that economic evaluation of headache services, in terms of outcomes and costs, is feasible as well as necessary. Furthermore, it is strongly supportive of the proposed intervention, while its framework is general enough to be easily adapted and implemented across Europe. [ABSTRACT FROM AUTHOR]

Background: This paper examines two state-led public-private demand-side financial support programs aiming to raise hospital delivery rates in two neighbouring Indian states-Gujarat and Madhya Pradesh. The national Janani Suraksha Yojana (JSY) was complemented with a public-private partnership program Janani Sahayogi Yojana (JSaY) in Madhya Pradesh in which private obstetricians were paid to deliver poor women. A higher amount was paid for caesarean sections (CS) than for vaginal deliveries (VD). In Gujarat state, the state program Chiranjeevi Yojana (CY) paid private obstetricians a fixed amount for a block 100 deliveries irrespective of delivery mode. The two systems thus offered an opportunity to observe the influence of supplier-induced demand (SID) from opposite incentives related to delivery mode. Methods: The data from the two programs was sourced from the Departments of Health and Family Welfare, Governments of Gujarat and Madhya Pradesh, India. Results: In JSaY program the CS rate increased from 26.6 % (2007-2008) to 40.7 % (2010-2011), against the background rate for CS in Madhya Pradesh, of only 4.9 % (2004-2006). Meanwhile in CY program in Gujarat, the CS rate decreased to 4.3 % (2010-2011) against a background CS rate of 8.1 % (2004-2006). Conclusions: The findings from India are unique in that they not only point to a significant impact from the introduction of the financial incentives but also how disincentives have an inverse impact on the choice of delivery method. [ABSTRACT FROM AUTHOR]

Youth with autism spectrum disorders (ASD) without intellectual disability frequently experience academic problems, in part due to executive functioning (EF) deficits. There are currently no evidence-based interventions targeting academic EF skills (e.g., organization, prioritization, etc.) for middle school youth with ASD. The need is critical given increasing demands on these skills during the transition from elementary to middle school. An intervention targeting academic EF skills, Achieving Independence and Mastery in School (AIMS), was recently developed. This paper reports on an open trial of the AIMS—Outpatient intervention with 21 middle schoolers with ASD. Results suggest high feasibility/satisfaction, and improved EF, particularly in the domains of organization and materials management. These promising results support further intervention development work and suggest that academic EF skills are malleable in youth with ASD. [ABSTRACT FROM AUTHOR]

The current study describes the design, implementation, and analysis of a professional development programme using a Lesson Study model to enhance awareness in preschool professionals regarding inclusive education for children with autism spectrum disorder. The mixed method approach included pre- and post-intervention questionnaires, audio-recordings of group seminars, and an interview. The results indicated an increase in autism awareness among the professionals, suggesting that professionals changed their practice as a result of the programme. This was particularly clear regarding making adjustments to the learning environment and taking measures to prevent challenging situations. In addition to describing the implementation of a professional development programme in a preschool, this paper emphasises the importance of appropriate conditions for such initiatives. [ABSTRACT FROM AUTHOR]

The school-based mental health promotion and suicide prevention universal program Youth Aware of Mental Health (YAM) significantly reduces incident suicide attempts and severe suicidal ideation. This paper aims at elucidating psychological mechanisms underlying YAM's efficacy. Our hypothesis is that YAM operates through interactions with coping strategies (CS) on the reduction of suicidal ideation (SI). In the Saving and Empowering Young Lives in Europe (SEYLE) study, five coping strategies were assessed at baseline (T0) and 12-month follow-up (T12): "learning", "help-seeking", "arts", "sports" and "fight". We analyzed interactions between the YAM intervention, coping strategies and SI in the YAM group (N = 1693) and the minimal intervention group (N = 1909), after excluding prevalent cases with SI and previous suicide attempts from our total sample (N = 5654). General Linear Mixed Model regressions were performed. The present study confirms that coping strategies play an influential role on suicidal ideation. Our results showed that YAM acts whatever the prevailing coping strategies used. It is particularly efficient for pupils insufficiently using adaptive coping strategies such as LEARN and HELP-SEEKING or using maladaptive coping strategies, such as ARTS and FIGHT. The socialization induced by the YAM intervention seems to be a strong component of its efficiency. [ABSTRACT FROM AUTHOR]