Developing inclusive public involvement and engagement activities with secondary school students and educational professionals: a protocol.

BACKGROUND: Public involvement and engagement (PI&E) is increasingly recognised as an important component of research. It can offer valuable insights from those with experiential knowledge to improve research quality, relevance, and reach. Similarly, schools are ever more common sites for health research and, more recently, PI&E. However, 'gold-standard' practice is yet to be established, and activities/approaches remain underreported. As a result, knowledge can remain localised or lost. Diversity and inclusion also remains a challenge. METHODS: This protocol has been informed by UK national guidance, evidence-based frameworks and available implementation literature. It describes both rationale and approach to conducting PI&E activities within a secondary school context. Activities are designed to be engaging, safe and accessible to young people with diverse experiences, with scope to be iteratively developed in line with public collaborator preference. DISCUSSION: Young people should be architects of their involvement and engagement. Ongoing appraisal and transparency of approaches to PI&E in school settings is crucial. Expected challenges of implementing this protocol include facilitating a safe space for the discussion of sensitive topics, absence and attrition, recruiting students with a diverse range of experiences, and potential knowledge and capacity barriers of both facilitator and contributors. Activities to mitigate these risks are suggested and explored.

Schools are increasingly becoming hubs for health research. However, there is a lack of knowledge about how researchers, schools and students can best work together to shape the studies we do. This is a problem as, in the world of research, involving those with first hand experiences (public collaborators) in the research process is seen as crucial.This protocol outlines our plan for conducting public involvement and engagement activities in secondary schools. It is based on national guidance and existing evidence. The goal is to make these activities interesting, safe, and accessible to young people with diverse experiences. The approach is designed to be flexible, allowing adjustments based on the preferences of the public collaborators.We acknowledge that we may face some difficulties with our approach. This may include challenges in recruitment of public collaborators, dealing with absence and attrition, and creating a safe space for discussing sensitive topics. Collaborators from both academic and lived backgrounds may also experience barriers in knowledge and capacity. This protocol suggests activities to address and overcome these challenges. We emphasise the need for ongoing evaluation and transparency in public involvement and engagement approaches within school settings.

A hybrid digital parenting programme to prevent abuse of adolescents in Tanzania: statistical analysis plan for a pragmatic cluster randomised controlled trial.

BACKGROUND: Globally, violence against children poses substantial health and economic challenges, with estimated costs nearing USD 7 trillion. This prompts the urgent call for effective evidence-based interventions in preventing and mitigating violence against children. ParentApp is a mobile, open-source application designed to offer a remote version of the Parenting for Lifelong Health (PLH) programme. ParentApp is the first digital parenting intervention for caregivers of adolescents aged 10-17 years to be tested in low- and middle-income settings. METHODS: This study is a pragmatic, two-arm, cluster-randomised trial in Mwanza, Tanzania's urban and peri-urban areas. Assessments are set for baseline, 1 month post-intervention, and 12 months post-intervention. We randomised 80 clusters, each with about 30 caregiver-adolescent dyads, with a 1:1 ratio stratified by urban or peri-urban location. Both arms receive an entry-level smartphone preloaded with Kiswahili apps-ParentApp for intervention and WashApp control. The primary method of analysis will be generalised linear mixed-effects models with adjustment for person-level characteristics and multiple imputation. In three-level models, measurement waves are nested within a person, nested within a sub-ward. Regressions will constrain groups to be equal at baseline and include covariates for stratification, percentage of male caregivers, and individual-level characteristics. DISCUSSIONS: Preparations for the trial began in December 2022, including community mobilisation and sensitisation. Rolling recruitment, baseline data collection, and implementation onboarding took place between April and September 2023. One-month post-test data collection began in August 2023 and thus far achieved 97% and 94% retention rates for caregivers and adolescents respectively. Final post-test data collection will begin in September 2024, anticipated to run until April 2025. This SAP was submitted to the journal before the interim analysis to preserve scientific integrity under a superiority hypothesis testing framework. TRIAL REGISTRATION: The trial was registered on the Open Science Framework on 14 March 2023: https://doi.org/10.17605/OSF.IO/T9FXZ . The trial protocol was published in Trials 25, 119 (2024): Baerecke, L., Ornellas, A., Wamoyi, J. et al. A hybrid digital parenting programme to prevent abuse of adolescents in Tanzania: study protocol for a pragmatic cluster-randomised controlled trial. Trials 25, 119 (2024). https://doi.org/10.1186/s13063-023-07893-x .

Interventions for primary prevention of cardiovascular disease: umbrella review of systematic reviews.

Background: Cardiovascular diseases are the leading cause of death globally. The aim of this overview of systematic reviews was to compare the effectiveness of different pharmacological and non-pharmacological interventions for the primary prevention of cardiovascular disease. Methods: A structured search of the Cochrane Database of Systematic Reviews, MEDLINE, EMBASE and the Database of Abstracts of Reviews of Effects archive was conducted to find systematic reviews that reported the effect of various pharmacological and non-pharmacological interventions for the primary prevention of cardiovascular disease from inception to March 2021. References of included studies were also checked. The included systematic reviews' methodological quality was assessed using the Assessment of Multiple Systematic Reviews 2 instrument (range, 0-16). The outcomes of each included review's meta-analysis were extracted and described narratively. Results: This study analysed 95 systematic reviews, including 41 on non-pharmacological interventions and 54 on pharmacological interventions for cardiovascular health. The majority of the reviews focused on lipid-lowering interventions (n = 25) and antiplatelet medications (n = 21), followed by nutritional supplements, dietary interventions, physical activity, health promotion and other interventions. Only 1 of the 10 reviews addressing cardiovascular mortality showed a potential benefit, while the others found no effect. Antiplatelets were found to have a beneficial effect on all-cause mortality in 2 out of 12 meta-analyses and on major cardiovascular disease events in 8 out of 17 reviews. Lipid-lowering interventions showed beneficial effects on cardiovascular disease mortality, all-cause mortality and major cardiovascular disease events in varying numbers of the reviews. Glucose-lowering medications demonstrated significant benefits for major cardiovascular events, coronary heart disease events and mortality. However, the combination of dietary interventions, physical activities, nutritional supplements and polypills showed little or no significant benefit for major cardiovascular outcomes or mortality. Future work and limitations: More research is needed to determine whether the effect of treatment varies depending on population characteristics. The findings of this review should be interpreted with caution because the majority of studies of non-pharmacological interventions compare primary prevention with usual care, which may include recommended pharmacological treatment in higher-risk patients (e.g. statins and/or antihypertensive medications, etc.). In addition, randomised controlled trial evidence may be better suited to the study of pharmacological interventions than dietary and lifestyle interventions. Conclusions: This umbrella review captured the variability in different interventions on randomised controlled trial evidence on interventions for primary prevention of cardiovascular disease and identified areas that may benefit from further research. Specifically, this review focused on randomised controlled trial evidence on interventions for primary prevention of cardiovascular disease. Researchers may use these findings as a resource to direct new intervention studies and network meta-analyses to compare the efficacy of various interventions based on these findings. Funding: This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) programme as award number 17/148/05.

Heart and blood vessel diseases are the top cause of death worldwide. This study aimed to compare the effectiveness of various drug-based and non-drug-based methods in preventing these diseases. We searched databases like Cochrane, MEDLINE, EMBASE and the Database of Abstracts of Reviews of Effects archive to find reviews about different ways to prevent heart and blood vessel diseases up until March 2021. The results showed that only 1 out of 10 reviews found a possible benefit in reducing heart-related deaths, while the other 9 found no effect. Medicines that lower blood sugar levels had a positive impact on reducing major heart events, heart disease and death. However, combining dietary changes, exercise, nutritional supplements and polypills had little or no effect on reducing heart-related events, deaths due to heart disease or deaths from all causes. This review examined the available evidence on ways to prevent heart and blood vessel diseases and identified areas where more research could be beneficial. Future studies could compare the effectiveness of different interventions using new methods and analyses.

Hard to reach? Methodological challenges researching vulnerable, gang-involved, young people.

INTRODUCTION: Research with young people (YP) is ethically challenging and bound in a complex maze of issues relating to power, voice and representation. Such sensitivities mean that the challenges raised in researching marginalised YP are often hard to navigate. This paper reports on research carried out with YP to explore links between mental health, school exclusion and involvement in criminal gangs. It aims to provide a practical guide to negotiating some of the methodological and ethical challenges experienced. METHOD: In-depth interviews conducted with 28 YP (aged 14-24 years) who were gang involved or seen to be at risk of gang involvement. Research was conducted in youth clubs, alternative provision and youth justice settings. RESULTS: OBSERVATIONS/REFLECTIONS: We reflect on how navigating ethics can create barriers to involving YP as primary informants in research. We consider why it is important to overcome these hurdles and how public engagement work with recognised gatekeepers and the use of creative interview methods can facilitate meaningful encounters, where YP feel able to share valuable insights into their lives. CONCLUSION: Alongside a number of specific learning points, the paper reflects on theories behind research with YP, including the need for recognition of power imbalances and reflexivity. It concludes with thoughts on the practical realities of achieving meaningful participation or an 'authentic voice' with marginalised groups and the importance of this in informing policy and practice. PATIENT OR PUBLIC CONTRIBUTION: The focus of this work was to collect experiences of YP who are recognised as gang-involved or at risk of being so, with a view to informing health and education policies. The scoping study for the project involved extensive public engagement work with YP exploring and trialling suitable methods of accessing, recruiting and ultimately interviewing this target group. This is central to the discussion within the body of the paper.

Development of a school-based programme for mental health promotion and prevention among adolescents in Nepal and South Africa.

Introduction: Adolescence is a critical time for mental health promotion and prevention and establishing healthy behaviours. Implementing universal, school-based psychosocial interventions can improve short- and long-term health trajectories for adolescents. While these interventions may offer important opportunities for fostering skills and relationships, few school-based interventions have been developed for and tested in low- and middle-income countries (LMICs) where adolescent mental health needs may be significant and under-served. This manuscript details the development of a multi-component, universal school-based intervention, Health Action in ScHools for a Thriving Adolescent Generation (HASHTAG), for adolescents aged 12-15 years in Nepal and South Africa. Methods and results: We describe HASHTAG's development over four phases, combining methods and results as each phase was iteratively conducted between 2018 and 2021. Phase 1 included a systematic review and components analysis, building from WHO guidelines for adolescent mental health. Seven components were strongly supported by the evidence: emotional regulation, stress management, mindfulness, problem-solving, interpersonal skills, assertiveness training, and alcohol and drug education. Phase 2 encompassed site selection, theory of change development, and formative research engagements; research teams in each site engaged adolescents and key adult stakeholders to identify priorities for intervention. Stakeholders voiced preferences for external facilitators and key content and delivery for intervention sessions. These findings informed Phase 3, a draft manual of HASHTAG, including a whole-school component, called Thriving Environment in Schools, and a classroom-based, six-session component, Thrive Together. In Phase 4, participants engaged in consultative workshops to review and contextualise content by country, preparing HASHTAG for implementation in a feasibility trial. Minor adaptations were made in Nepal, including using school nurses and adjusting take-home materials; both country's workshops identified practical considerations for implementing activities. Conclusions: HASHTAG was designed around core evidence-based components to increase translatability across LMICs, while enabling country-specific tailoring to enhance feasibility. Future research will test whether this multi-component, whole-school approach can improve adolescent mental health.

A Factorial Randomized Controlled Trial to Optimize User Engagement With a Chatbot-Led Parenting Intervention: Protocol for the ParentText Optimisation Trial.

BACKGROUND: Violence against children (VAC) is a serious public health concern with long-lasting adverse effects. Evidence-based parenting programs are one effective means to prevent VAC; however, these interventions are not scalable in their typical in-person group format, especially in low- and middle-income countries where the need is greatest. While digital delivery, including via chatbots, offers a scalable and cost-effective means to scale up parenting programs within these settings, it is crucial to understand the key pillars of user engagement to ensure their effective implementation. OBJECTIVE: This study aims to investigate the most effective and cost-effective combination of external components to optimize user engagement with ParentText, an open-source chatbot-led parenting intervention to prevent VAC in Mpumalanga, South Africa. METHODS: This study will use a mixed methods design incorporating a 2 × 2 factorial cluster-randomized controlled trial and qualitative interviews. Parents of adolescent girls (32 clusters, 120 participants [60 parents and 60 girls aged 10 to 17 years] per cluster; N=3840 total participants) will be recruited from the Ehlanzeni and Nkangala districts of Mpumalanga. Clusters will be randomly assigned to receive 1 of the 4 engagement packages that include ParentText alone or combined with in-person sessions and a facilitated WhatsApp support group. Quantitative data collected will include pretest-posttest parent- and adolescent-reported surveys, facilitator-reported implementation data, and digitally tracked engagement data. Qualitative data will be collected from parents and facilitators through in-person or over-the-phone individual semistructured interviews and used to expand the interpretation and understanding of the quantitative findings. RESULTS: Recruitment and data collection started in August 2023 and were finalized in November 2023. The total number of participants enrolled in the study is 1009, with 744 caregivers having completed onboarding to the chatbot-led intervention. Female participants represent 92.96% (938/1009) of the sample population, whereas male participants represent 7.03% (71/1009). The average participant age is 43 (SD 9) years. CONCLUSIONS: The ParentText Optimisation Trial is the first study to rigorously test engagement with a chatbot-led parenting intervention in a low- or middle-income country. The results of this study will inform the final selection of external delivery components to support engagement with ParentText in preparation for further evaluation in a randomized controlled trial in 2024. TRIAL REGISTRATION: Open Science Framework (OSF); https://doi.org/10.17605/OSF.IO/WFXNE. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/52145.

What is the volume, quality and characteristics of evidence relating to the effectiveness and cost-effectiveness of multi-disciplinary occupational health interventions aiming to improve work-related outcomes for employed adults? An evidence and gap map of systematic reviews.

Background: In the UK, tens of millions of working days are lost due to work-related ill health every year, costing billions of pounds. The role of Occupational Health (OH) services is vital in helping workers to maintain employment when they encounter injury or illness. OH providers traditionally rely on a clinical workforce to deliver these services, particularly doctors and nurses with OH qualifications. However, the increasing demand for OH services is unlikely to be met in the future using this traditional model, due to the declining number of OH-trained doctors and nurses in the UK. Multi-disciplinary models of OH delivery, including a more varied range of healthcare and non-healthcare professionals, could provide a way to meet this new demand for OH services. There is a need to identify collaborative models of OH service delivery and review their effectiveness on return-to work outcomes. There is an existing pool of systematic review evidence evaluating workplace based, multi-disciplinary OH interventions, but it is difficult to identify which aspects of the content and/or delivery of these interventions may be associated with improved work-related outcomes. Objectives: The aim of this evidence and gap map (EGM) was to provide an overview of the systematic review evidence that evaluates the effectiveness and cost-effectiveness of multi-disciplinary OH interventions intending to improve work-related outcomes. Search Methods: In June 2021 we searched a selection of bibliographic databases and other academic literature resources covering a range of relevant disciplines, including health care and business studies, to identify systematic review evidence from a variety of sectors of employment. We also searched Google Search and a selection of topically relevant websites and consulted with stakeholders to identify reports already known to them. Searches were updated in February 2023. Selection Criteria: Systematic reviews needed to be about adults (16 years or over) in employment, who have had absence from work for any medical reason. Interventions needed to be multi-disciplinary (including professionals from different backgrounds in clinical and non-clinical professions) and designed to support employees and employers to manage health conditions in the workplace and/or to help employees with health conditions retain and/or return to work following medical absence. Effectiveness needed to be measured in terms of return to work, work retention or measures of absence, or economic evaluation outcomes. These criteria were applied to the title and abstract and full text of each systematic review independently by two reviewers, with disagreements resolved through discussion. We awarded each systematic review a rating of 'High', 'Medium' or 'Low' relevance to indicate the extent to which the populations, interventions and their contexts synthesised within the review were consistent with our research question. We also recorded the number of primary studies included within each of the 'High' and 'Medium' reviews that were relevant to research question using the same screening process applied at review level. Data Collection and Analysis: Summary data for each eligible review was extracted. The quality of the systematic reviews, rated as 'High' or 'Medium' relevance following full text screening, was appraised using the AMSTAR-2 quality appraisal tool. All data were extracted by one reviewer and checked by a second, with disagreements being settled through discussion. Summary data for all eligible systematic reviews were tabulated and described narratively. The data extracted from reviews of 'High' and 'Medium' relevance was imported into EPPI-Mapper software to create an EGM. Stakeholder Involvement: We worked alongside commissioners and policy makers from the Department of Health and Social Care (DHSC) and Department of Work and Pensions (DWP), OH personnel, and people with lived experience of accessing OH services themselves and/or supporting employees to access OH services. Individuals contributed to decision making at all stages of the project. This ensured our EGM reflects the needs of individuals who will use it. Main Results: We identified 98 systematic reviews that contained relevant interventions, which involved a variety of professionals and workplaces, and which measured effectiveness in terms of return to work (RTW). Of these, we focused on the 30 reviews where the population and intervention characteristics within the systematic reviews were considered to be of high or medium relevance to our research questions. The 30 reviews were of varying quality, split evenly between High/Moderate quality and Low/Critically-Low quality ratings. We did not identify any relevant systematic review evidence on any other work-related outcome of interest. Interventions were heterogenous, both within and across included systematic reviews. The EGM is structured according to the health condition experienced by participants, and the effectiveness of the interventions being evaluated, as reported within the included systematic reviews. It is possible to view (i) the quality and quantity of systematic review evidence for a given health condition, (ii) how review authors assessed the effectiveness or cost-effectiveness of the interventions evaluated. The EGM also details the primary studies relevant to our research aim included within each review. Authors' Conclusions: This EGM map highlights the array of systematic review evidence that exists in relation to the effectiveness or cost-effectiveness of multi-disciplinary, workplace-based OH interventions in supporting RTW. This evidence will allow policy makers and commissioners of services to determine which OH interventions may be most useful for supporting different population groups in different contexts. OH professionals may find the content of the EGM useful in identifying systematic review evidence to support their practice. The EGM also identifies where systematic review evidence in this area is lacking, or where existing evidence is of poor quality. These may represent areas where it may be particularly useful to conduct further systematic reviews.

COVID-19, lockdowns, and the mental wellbeing of LGBTQ people in Australia.

LGBTQ communities around the world entered the COVID-19 pandemic with generally high rates of poor mental health and faced additional challenges including stigma, discrimination, and barriers to care. This study sample was drawn from a survey of 3135 LGBTQ adults residing in Australia during the pandemic. Regression analysis was used to explore individual differences in psychological distress and perceived change in mental wellbeing since the onset of the pandemic as well as the impact of lockdowns, by taking advantage of a natural experiment comparing the states that experienced more extensive lockdowns (Victoria and New South Wales) to the rest of Australia. The burden of mental health was found to vary across gender, sexual orientation, age, and area of residence. While no impact of lockdowns on psychological distress was observed, participants living in the states of Victoria (ß = -0.15; 95% CI = -0.23, -0.07) and New South Wales (ß = -0.13; 95% CI = -0.21, -0.05) self-reported a more negative impact of the pandemic on their mental wellbeing compared to the rest of the country. The findings suggest that the COVID-19 pandemic had a negative impact on the mental wellbeing of LGBTQ populations, particularly among those who experienced extensive lockdowns and highlight the need for increased efforts to enable access to mental health supports during times of crisis.

Disruptive child behavior severity and parenting program session attendance: Individual participant data meta-analysis.

OBJECTIVE: We tested if baseline disruptive child behavior problem severity predicts parental attendance at sessions of a parenting group program. METHOD: We used a database of randomized trials of the Incredible Years parenting program in Europe and restricted the sample to participants randomized to the intervention arm. Using baseline Eyberg Child Behavior Inventory scores, we distinguished between trial-level problem severity and child-level problem severity, compared linear and quadratic functional forms at both levels, and considered cross-level interactions, all in a multilevel Poisson regression framework. RESULTS: Drawing on 918 participants in 12 trials, we found that within trials, parents of children with the least and most severe problems attended fewer sessions. Between trials, each additional 10-point increase in the Eyberg Child Behavior Inventory trial mean predicted an 11% increase in attendance. Models including child sex, age, or family low-income did not change coefficients or their interpretation. CONCLUSIONS: Our findings suggest that although generally attendance is higher in parents of children with more challenging behavior, it seems difficult for group programs to keep families with the least or most severe problems engaged. Our findings call for the need to better understand the conditions under which lower attendance translates into equivalent or lesser program benefits. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Support for primary care prescribing for adult ADHD in England: national survey.

BACKGROUND: Attention deficit hyperactivity disorder (ADHD) is a common neurodevelopmental disorder with effective pharmacological treatments that improve symptoms and reduce complications. NICE guidelines recommend primary care practitioners prescribe medication for adult ADHD under shared care agreements with adult mental health services (AMHS). However, provision remains uneven, with some practitioners reporting a lack of support. AIM: This study aimed to describe supportive elements (prescribing, shared care, AMHS availability) of primary care prescribing for adult ADHD medication in England, to inform service improvement and improve access for this underserved population. DESIGN AND SETTING: Three interlinked cross-sectional surveys asked every integrated care board (ICB) in England (Commissioners), and convenience samples of healthcare professionals (HP) and people with lived experience (LE), about elements supporting pharmacological treatment of ADHD in primary care. METHOD: Descriptive analyses used percentages and confidence intervals to summarise responses by stakeholder group. Variations in reported provision and practice were explored and displayed visually using mapping software. RESULTS: Data from 782 respondents (42 Commissioners; 331 HP; 409 LE) revealed differences in reported provision by stakeholder group, including for prescribing (94.6% of HP vs 62.6% of LE). Over 40% of respondents reported extended AMHS waiting times of two years or more. There was some variability by NHS region, for example London had highest rates of HP reported prescribing (100%), and lowest reported extended waiting times (25.0%). CONCLUSION: Elements supporting appropriate shared care prescribing of ADHD medication via primary care are not universally available in England. Co-ordinated approaches are needed to address these gaps.

Treatment Effect Waning Assumptions: A Review of National Institute of Health and Care Excellence Technology Appraisals.

OBJECTIVES: This study aims to review the National Institute of Health and Care Excellence (NICE) technology assessments to gain insights into the implementation of treatment effect (TE) waning, whereby the hazard or survival in an assessed technology converges to that of the comparator. This analysis aims to contribute to inform future guidance in this area. METHODS: Technology appraisals published October 20, 2021 to September 20, 2023 were reviewed and data extracted on TE waning circumstances, methods, and rationale to compile a database based on 3 research questions: When are TE waning assumptions used? What methods are used? Why have the company/Evidence Assessment Group/committee preferred these methods? RESULTS: Both the evidence assessment group/company and the committee included TE waning assumptions in 28 appraisals. There was no pattern of waning assumptions between shorter (<20 years) and longer (>20 years) time horizons. The most prominent time point for applying waning assumptions was at 5 years, with 30 out of 59 (50.8%) of the methods applied used 5 years. Stopping rules were used in 21 out of 30 (70.1%) of the appraisals for which the committee included waning, and waning assumptions were used more in oncology. The most common reason given for including TE waning assumptions was precedent from prior appraisals. CONCLUSIONS: Considerable heterogeneity existed in both the methods used and justifications given for TE waning assumptions. This variability poses a risk of inconsistent decision making. Reliance on past appraisals emphasizes the necessity to advocate for evidence-driven approaches and underscores the demand for guidance on suitable methods for incorporating assumptions.

Protocol for the Adolescent Menstrual Experiences and Health Cohort (AMEHC) Study in Khulna, Bangladesh: A Prospective cohort to quantify the influence of menstrual health on adolescent girls' health and education outcomes.

BACKGROUND: Menstrual health is essential for gender equity and the well-being of women and girls. Qualitative research has described the burden of poor menstrual health on health and education; however, these impacts have not been quantified, curtailing investment. The Adolescent Menstrual Experiences and Health Cohort (AMEHC) Study aims to describe menstrual health and its trajectories across adolescence, and quantify the relationships between menstrual health and girls' health and education in Khulna, Bangladesh. METHODS AND ANALYSIS: AMEHC is a prospective longitudinal cohort of 2016 adolescent girls recruited at the commencement of class 6 (secondary school, mean age=12) across 101 schools selected through a proportional random sampling approach. Each year, the cohort will be asked to complete a survey capturing (1) girls' menstrual health and experiences, (2) support for menstrual health, and (3) health and education outcomes. Survey questions were refined through qualitative research, cognitive interviews and pilot survey in the year preceding the cohort. Girls' guardians will be surveyed at baseline and wave 2 to capture their perspectives and household demographics. Annual assessments will capture schools' water, sanitation and hygiene, and support for menstruation and collect data on participants' education, including school attendance and performance (in maths, literacy). Cohort enrolment and baseline survey commenced in February 2023. Follow-up waves are scheduled for 2024, 2025 and 2026, with plans for extension. A nested subcohort will follow 406 post-menarche girls at 2-month intervals throughout 2023 (May, August, October) to describe changes across menstrual periods. This protocol outlines a priori hypotheses regarding the impacts of menstrual health to be tested through the cohort. ETHICS AND DISSEMINATION: AMEHC has ethical approval from the Alfred Hospital Ethics Committee (369/22) and BRAC James P Grant School of Public Health Institutional Review Board (IRB-06 July 22-024). Study materials and outputs will be available open access through peer-reviewed publication and study web pages.

A Hybrid Digital Parenting Program Delivered Within the Malaysian Preschool System: Protocol for a Feasibility Study of a Small-Scale Factorial Cluster Randomized Trial.

BACKGROUND: The United Nations' Sustainable Development Goal 4, and particularly target 4.2, which seeks to ensure that, by 2030, all children have access to quality early childhood development, care, and preprimary education so that they are ready for primary education, is far from being achieved. The COVID-19 pandemic compromised progress by disrupting education, reducing access to well-being resources, and increasing family violence. Evidence from low- and middle-income countries suggests that in-person parenting interventions are effective at improving child learning and preventing family violence. However, scaling up these programs is challenging because of resource constraints. Integrating digital and human-delivered intervention components is a potential solution to these challenges. There is a need to understand the feasibility and effectiveness of such interventions in low-resource settings. OBJECTIVE: This study aims to determine the feasibility and effectiveness of a digital parenting program (called Naungan Kasih in Bahasa Melayu [Protection through Love]) delivered in Malaysia, with varying combinations of 2 components included to encourage engagement. The study is framed around the following objectives: (1) to determine the recruitment, retention, and engagement rates in each intervention condition; (2) to document implementation fidelity; (3) to explore program acceptability among key stakeholders; (4) to estimate intervention costs; and (5) to provide indications of the effectiveness of the 2 components. METHODS: This 10-week factorial cluster randomized trial compares ParentText, a chatbot that delivers parenting and family violence prevention content to caregivers of preschool-aged children in combination with 2 engagement components: (1) a WhatsApp support group and (2) either 1 or 2 in-person sessions. The trial aims to recruit 160 primary and 160 secondary caregivers of children aged 4-6 years from 8 schools split equally across 2 locations: Kuala Lumpur and Negeri Sembilan. The primary outcomes concern the feasibility and acceptability of the intervention and its components, including recruitment, retention, and engagement. The effectiveness outcomes include caregiver parenting practices, mental health and relationship quality, and child development. The evaluation involves mixed methods: quantitative caregiver surveys, digitally tracked engagement data of caregivers' use of the digital intervention components, direct assessments of children, and focus group discussions with caregivers and key stakeholders. RESULTS: Overall, 208 parents were recruited at baseline December 2023: 151 (72.6%) primary caregivers and 57 (27.4%) secondary caregivers. In January 2024, of these 208 parents, 168 (80.8%) enrolled in the program, which was completed in February. Postintervention data collection was completed in March 2024. Findings will be reported in the second half of 2024. CONCLUSIONS: This is the first factorial cluster randomized trial to assess the feasibility of a hybrid human-digital playful parenting program in Southeast Asia. The results will inform a large-scale optimization trial to establish the most effective, cost-effective, and scalable version of the intervention. TRIAL REGISTRATION: OSF Registries; https://osf.io/f32ky. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/55491.

Effectiveness of Trauma-Informed Care Implementation in Health Care Settings: Systematic Review of Reviews and Realist Synthesis.

PURPOSE: Given the ubiquity of traumatic exposures and the profound impact of trauma on health, a trauma-informed care (TIC) approach in health care is critical. TIC seeks to promote safety within health care and prevent retraumatization. The lack of systems-level data has been a major barrier to TIC implementation. This study aimed to understand the mechanisms and outcomes effective in implementing TIC across health systems using a systematic review of reviews and realist synthesis. METHODS: A systematic search of MEDLINE, Embase, PsycINFO, Cumulative Index to Nursing and Allied Health Literature (CINAHL), and Applied Social Science Index & Abstracts identified reviews addressing TIC in health care published in the last 10 years in peer-reviewed journals. Realist synthesis methodology was used to develop context-mechanism-outcome configurations. Thematic analysis was performed to generate a framework for the mechanisms of implementation that produce successful TIC outcomes. RESULTS: Sixteen articles featuring varied review types were included. The results, highlighting the strategies that lead to improved outcomes for patients and systems, were mapped to SAMHSA's 10 TIC implementation domains, including engagement and involvement; training and workforce development; cross-sector collaboration; screening, assessment, and treatment services; governance and leadership; policy; evaluation; progress monitoring and quality assurance; financing; and physical environment. CONCLUSION: The findings support the use of SAMHSA's 10 implementation domains in varied health care contexts to facilitate effective TIC processes. Future work should continue to evaluate the effectiveness of TIC approaches and may consider how health equity and strengths-based approaches fit within SAMHSA's framework.

Reporting of equity in observational epidemiology: A methodological review.

Background: Observational studies can inform how we understand and address persisting health inequities through the collection, reporting and analysis of health equity factors. However, the extent to which the analysis and reporting of equity-relevant aspects in observational research are generally unknown. Thus, we aimed to systematically evaluate how equity-relevant observational studies reported equity considerations in the study design and analyses. Methods: We searched MEDLINE for health equity-relevant observational studies from January 2020 to March 2022, resulting in 16 828 articles. We randomly selected 320 studies, ensuring a balance in focus on populations experiencing inequities, country income settings, and coronavirus disease 2019 (COVID-19) topic. We extracted information on study design and analysis methods. Results: The bulk of the studies were conducted in North America (n = 95, 30%), followed by Europe and Central Asia (n = 55, 17%). Half of the studies (n = 171, 53%) addressed general health and well-being, while 49 (15%) focused on mental health conditions. Two-thirds of the studies (n = 220, 69%) were cross-sectional. Eight (3%) engaged with populations experiencing inequities, while 22 (29%) adapted recruitment methods to reach these populations. Further, 67 studies (21%) examined interaction effects primarily related to race or ethnicity (48%). Two-thirds of the studies (72%) adjusted for characteristics associated with inequities, and 18 studies (6%) used flow diagrams to depict how populations experiencing inequities progressed throughout the studies. Conclusions: Despite over 80% of the equity-focused observational studies providing a rationale for a focus on health equity, reporting of study design features relevant to health equity ranged from 0-95%, with over half of the items reported by less than one-quarter of studies. This methodological study is a baseline assessment to inform the development of an equity-focussed reporting guideline for observational studies as an extension of the well-known Strengthening Reporting of Observational Studies in Epidemiology (STROBE) guideline.

The impact of school-based creative bibliotherapy interventions on child and adolescent mental health: a systematic review and realist synthesis protocol.

BACKGROUND: There is a need to identify evidence-based interventions to be delivered in schools that can be used to improve child and adolescent mental health and wellbeing. Creative bibliotherapy is one proposed intervention. However, there has been, to date, no comprehensive assessment of the evidence for its impact on mental health and wellbeing. To fill this gap, we will conduct a systematic review and realist synthesis. METHODS: A systematic search of the bibliographic databases APA PsycINFO, Medline (via Ovid), CINAHL, ERIC, Education Research Complete (via EBSCOhost) and Web of Science (SCI, SSCI, AHCI, ESCI) for school-based creative bibliotherapy interventions on child and adolescent mental health. Types of study to be included: cohort studies, non-randomised comparative evaluations, randomised controlled trials. The data from all included studies will be summarised descriptively and strength of evidence appraised. This is a potentially large field of practice, with heterogeneous interventions; we will use methods from intervention components analysis to describe and categorise the range of components and approaches used in included interventions. To understand how interventions work and in which contexts, we will use methods from realist synthesis to develop an exploratory account of mechanisms in different settings and for different young people (contexts). DISCUSSION: Findings will assess the range of evidence for the impact of creative bibliotherapy on child and adolescent mental health and wellbeing, the strength of evidence for the impact identified, and describe potential mechanisms. This review will be useful for a wide range of stakeholders considering implementing or developing interventions using creative bibliotherapy in school-based settings. SYSTEMATIC REVIEW REGISTRATION: This protocol was registered at the International Prospective Register of Systematic Reviews ( https://www.crd.york.ac.uk/prospero/ ), registration number CRD42023410333. This review is funded by Wellcome Trust (221457/Z/20/Z).

Study Preregistration: Individual Participant Data Meta-Analysis: Individual Differences in Mediators of Parenting Program Effects on Disruptive Behavior.

Parenting programs are the most widely used strategy to prevent and reduce children's disruptive behavior,1 and yet we know very little about what exact changes in parenting behavior underlie program effects on disruptive child behavior. In fact, most studies have been unable to identify any mediators of parenting program effects.2 This is likely because, at least in part, individual trials tend to be underpowered to detect mediation effects,3 and are unable to take the known heterogeneity in program effects4 into account.

School-based interventions TO Prevent Dating and Relationship Violence and Gender-Based Violence: STOP-DRV-GBV systematic review.

Background: Schools have a duty of care to prevent violence between students but a significant amount of dating and relationship violence and gender-based violence occurs in schools. These are important public health issues with important longitudinal consequences for young people. Objectives: To understand functioning and effectiveness of school-based interventions for the prevention of dating and relationship violence and gender-based violence. Review methods: We undertook a mixed-methods systematic review to synthesise different types of evidence relating to school-based interventions for the prevention of dating and relationship violence and gender-based violence to understand if, how and in what ways these interventions are effective. We searched 21 databases and 2 trial registers and undertook forwards and backwards citation chasing, author contact and other supplementary search methods. Searches identified all literature published to June 2021. All screening was undertaken in duplicate and independently, and we quality appraised all included studies. Results: We included 247 reports (68 outcome evaluations, 137 process evaluations). Synthesis of intervention components produced an intervention typology: single-component, curricular, multicomponent, and multilevel programmes. Synthesis of intervention theories suggested that interventions aiming to increase students' sense of school belonging and sense of safety in the school building could encourage increased learning of prosocial skills and increased prosocial peer norms, and so potentially reducing dating and relationship violence and gender-based violence. Synthesis of factors affecting delivery highlighted school organisation and leaders who believed in the importance of addressing dating and relationship violence/gender-based violence, along with time and resources to deliver the interventions. The ease with which the intervention could be delivered and modified was also important. Meta-analysis found stronger evidence for intervention effectiveness in reducing dating and relationship violence than for gender-based violence, with significant long-term impacts on dating and relationship violence victimisation and perpetration, and some evidence that interventions in high-income countries could be effective for reducing victimisation and perpetration of gender-based violence in the long-term. Impacts on knowledge and attitudes were primarily short-term. Network meta-analysis did not suggest superiority of any intervention type. Moderation evidence suggested interventions reduced dating and relationship violence perpetration in boys more than girls, but reduced gender-based violence perpetration more in girls. Metaregression by intervention component did not explain heterogeneity in effectiveness, but qualitative comparative analysis suggested that reducing perpetration was important to reducing victimisation, and that perpetration could be reduced via focus on interpersonal skills, guided practice and (for gender-based violence) implementation of social structural components. Limitations: Despite an exhaustive search, trials may have been missed and risk of publication bias was high for several analyses. Conclusions: This is the most comprehensive systematic review of school-based interventions for dating and relationship violence and gender-based violence to date. It is clear that the prevention of dating and relationship violence and gender-based violence in schools will require longer-term investment to show benefit. Future work: Future research is needed to understand why intervention effectiveness appears stronger for dating and relationship violence than gender-based violence. Study registration: The study is registered as PROSPERO CRD42020190463. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme (NIHR award ref: NIHR130144) and is published in full in Public Health Research; Vol. 12, No. 3. See the NIHR Funding and Awards website for further award information.

Schools are places where dating and relationship violence and gender-based violence occur. Therefore, interventions conducted within schools are ideally placed to prevent and reduce dating and relationship violence and gender-based violence. We reviewed existing research on these interventions, exploring how they were expected to work, what factors affected their implementation in practice, how they had an impact on dating and relationship violence and gender-based violence, and what specific parts of the interventions were most effective and in what contexts. We defined what sort of evidence to include in the review, carried out a comprehensive search and found 247 reports on school-based interventions to prevent dating and relationship violence or gender-based violence, most of which were conducted in North America. Most interventions aimed to provide students with the knowledge, attitudes and skills needed to prevent perpetration and victimisation. They varied in complexity; some had one activity, others had multiple activities, some were integrated into the existing school curricula and others were complex in that they sought to change how schools as a whole respond to dating and relationship violence or gender-based violence. We theorised that complex interventions would bring about greater and more sustainable change, but this was not supported by our findings. The implementation of interventions was affected by factors such as school organisation and leaders who believed in the importance of addressing dating and relationship violence/gender-based violence, along with time and resources to deliver the interventions. The ease with which the intervention could be delivered and modified was also important. There was stronger evidence for intervention effectiveness in reducing dating and relationship violence than for gender-based violence, with significant long-term impacts on dating and relationship violence victimisation and perpetration. There was some evidence that interventions in high-income countries could be effective for reducing victimisation and perpetration of gender-based violence in the long-term. More complicated interventions were not more effective, and interventions tended to reduce dating and relationship violence perpetration in boys more than in girls. We have also been able to identify where there are gaps in available evidence, which may provide avenues for future research.

What is the quantity, quality and type of systematic review evidence available to inform the optimal prescribing of statins and antihypertensives? A systematic umbrella review and evidence and gap map.

OBJECTIVES: We aimed to map the systematic review evidence available to inform the optimal prescribing of statins and antihypertensive medication. DESIGN: Systematic umbrella review and evidence and gap map (EGM). DATA SOURCES: Eight bibliographic databases (Cochrane Database of Systematic Reviews, CINAHL, EMBASE, Health Management Information Consortium, MEDLINE ALL, PsycINFO, Conference Proceedings Citation Index-Science and Science Citation Index) were searched from 2010 to 11 August 2020. Update searches conducted in MEDLINE ALL 2 August 2022. We searched relevant websites and conducted backwards citation chasing. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: We sought systematic reviews of quantitative or qualitative research where adults 16 years+ were currently receiving, or being considered for, a prescription of statin or antihypertensive medication. Eligibility criteria were applied to the title and abstract and full text of each article independently by two reviewers. DATA EXTRACTION AND SYNTHESIS: Quality appraisal was completed by one reviewer and checked by a second. Review characteristics were tabulated and incorporated into an EGM based on a patient care pathway. Patients with lived experience provided feedback on our research questions and EGM. RESULTS: Eighty reviews were included within the EGM. The highest quantity of evidence focused on evaluating interventions to promote patient adherence to antihypertensive medication. Key gaps included a lack of reviews synthesising evidence on experiences of specific interventions to promote patient adherence or improve prescribing practice. The evidence was predominantly of low quality, limiting confidence in the findings from individual reviews. CONCLUSIONS: This EGM provides an interactive, accessible format for policy developers, service commissioners and clinicians to view the systematic review evidence available relevant to optimising the prescribing of statin and antihypertensive medication. To address the paucity of high-quality research, future reviews should be conducted and reported according to existing guidelines and address the evidence gaps identified above.