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Abstract Background Parental domestic violence and abuse (DVA), mental ill-health (MH), and substance misuse (SU) can have a negative impact on both parents and children. However, it remains unclear if and how parental DVA, MH, and SU cluster and the impacts this clustering might have. We examined how parental DVA, MH, and SU cluster during early childhood, the demographic/contextual profiles of these clusters, and how these clusters relate to child MH trajectories. Methods We examined data from 15,377 families in the UK Millennium Cohort Study. We used: (1) latent class analysis to create groups differentially exposed to parental DVA, MH, and SU at age three; (2) latent growth curve modelling to create latent trajectories of child MH from ages 3–17; and (3) a case-weight approach to relate latent classes to child MH trajectories. Results We identified three latent classes: high-frequency alcohol use (11.9%), elevated adversity (3.5%), and low-level adversity (84.6%). Children in the elevated adversity class had higher probabilities of being from low-socioeconomic backgrounds and having White, younger parents. Children exposed to elevated adversity displayed worse MH at age three (intercept = 2.274; p

Abstract Background In 2021, more than two-thirds of the world’s children lived in a conflict-affected country. In 2022, 13 million Ukrainians were forced to flee their homes after Russia’s full-scale invasion. Hope Groups are a 12-session psychosocial, mental health, and parenting support intervention designed to strengthen parents, caregivers, and children affected by war and crisis. The primary objective of this study is to evaluate the effectiveness of Hope Groups among Ukrainians affected by war, compared to a wait-list control group. This protocol describes a promising decentralized intervention delivery model and an innovative research design, which estimates the causal effect of Hope Groups while prioritizing prompt delivery of beneficial services to war-affected participants. Methods This protocol describes a pragmatic cluster randomized controlled trial (RCT) among Ukrainians externally displaced, internally displaced within Ukraine, and living at home in war-affected areas. This study consists of 90 clusters with 4–7 participants per cluster, totaling approximately n = 450 participants. Intervention clusters will receive 12-session Hope Groups led by peer facilitators, and control clusters will be wait-listed to receive the intervention after the RCT concludes. Clusters will be matched on the facilitator performing recruitment and intervention delivery. Primary outcomes are caregiver mental health, violence against children, and positive parenting practices. Secondary outcomes include prevention of violence against women and caregiver and child well-being. Outcomes will be based on caregiver report and collected at baseline and endline (1-week post-intervention). Follow-up data will be collected among the intervention group at 6–8 weeks post-intervention, with aims for quasi-experimental follow-ups after 6 and 12 months, pending war circumstances and funding. Analyses will utilize matching techniques, Bayesian interim analyses, and multi-level modeling to estimate the causal effect of Hope Groups in comparison to wait-list controls. Discussion This study is the first known randomized trial of a psychosocial, mental health, and parenting intervention among Ukrainians affected by war. If results demonstrate effectiveness, Hope Groups hold the potential to be adapted and scaled to other populations affected by war and crisis worldwide. Additionally, methodologies described in this protocol could be utilized in crisis-setting research to simultaneously prioritize the estimation of causal effects and prompt delivery of beneficial interventions to crisis-affected populations. Trial registration This trial was registered on Open Science Framework on November 9, 2023. Registration: OSF.IO/UVJ67 .

Abstract 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 .

Abstract 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.

Abstract 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).

Abstract Introduction Clinical trials show improved progression‐free survival (PFS) and overall survival (OS) in first‐line metastatic renal cell carcinoma (mRCC) patients with immunotherapy containing systemic anti‐cancer therapies (SACT). However, in the favourable international metastatic renal cell cancer database consortium (IMDC) group there is no trial evidence for OS benefit despite clear PFS improvement when comparing anti‐VEGF tyrosine kinase inhibitor (TKI) monotherapy and (immunotherapy and TKI) IO/TKI combinations. Objective To assess the impact of first‐line SACT choice on the clinical outcomes of PFS and OS in mRCC. To evaluate this impact of initial SACT for allcomers and the favourable IMDC group. Methods A multicentre retrospective review of patients who started SACT for mRCC (01/01/2018–30/06/2021) at 17 UK NHS trusts. Patient demographics and IMDC group were analysed. Survival data were compared using Kaplan–Meier curves, and the statistical significance of differences in outcome between the groups was assessed with the log‐rank test. Univariable and multivariable Cox proportional hazard modelling estimate the hazard ratios (HRs) for survival outcomes associated with IMDC and treatment subtype. Results One thousand three hundred and nineteen patients were identified with a median age of 64. 294 (22.3%), 695 (52.7%) and 321 (24.3%) were IMDC group favourable, intermediate and poor, respectively. 311 (23.6%), 197 (14.9%) and 778 (59%) patients received checkpoint inhibitor and anti‐CTLA4 monoclonal antibody (IO/IO), IO/TKI and TKI first‐line SACT across all IMDC groups. Significant PFS improvement favouring IO/TKI versus TKI was demonstrated in allcomers HR = 0.61. In the favourable risk group, Log rank testing demonstrated a significant benefit for IO/TKI over TKI for PFS (HR = 0.60, 95% CI [0.39, 0.91]) and OS (HR = 0.42, 95% CI [0.18, 0.99]). Conclusion In this real‐world evidence cohort, we have shown OS and PFS benefit with IO/TKI versus TKI in the favourable IMDC risk group. This has not been previously reported from trial outcomes and would support use of front‐line IO/TKI in mRCC favourable risk patients.

Abstract 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.

Abstract Background Evidence-based parenting programmes have strong evidence in preventing and mitigating violence, but in-person programmes are challenging to deliver at scale. ParentApp is an open-source, offline-first app-based adaptation of the Parenting for Lifelong Health for Parents and Teens programme to promote playful and positive parenting, reduce risks for sexual violence victimisation, and prevent violence against adolescents. This study aims to evaluate the effectiveness and cost-effectiveness of ParentApp compared to an attention-control group. Methods This study is a two-arm pragmatic cluster-randomised controlled trial to test whether ParentApp reduces adolescent physical abuse, emotional abuse, and sexual violence risks and victimisation at 1 month and 12 months post-intervention. Caregivers of adolescents aged 10–17 years and their adolescent children (N = 2400 caregiver-adolescent dyads) will be recruited in urban and peri-urban communities in the Mwanza region of Tanzania. A total of 80 study clusters will be stratified and randomised (1:1) to the intervention group, who will receive ParentApp with support through a WhatsApp group, or to an attention-control group, who will receive a water, sanitation, and hygiene app. Quantitative data will be collected through outcomes questionnaires with caregivers and adolescents, administered at baseline, 4 months post-baseline, and 16 months post-baseline, as well as through routine implementation data and ParentApp engagement data. Qualitative data will be collected through individual interviews and focus groups with caregivers, adolescents, and implementing partner staff. Discussion App-based interventions have the potential to expand access to evidence-based parenting support, but currently lack rigorous evidence in low- and middle-income countries. This is the first known randomised control trial of a hybrid digital parenting programme to prevent the abuse of adolescents in low- and middle-income settings. Trial registration The trial was registered on the Open Science Framework on 14 March 2023, registration: OSF.IO/T9FXZ .

Abstract Introduction We conducted a systematic review of qualitative evidence to improve understanding of the processes and outcomes of redress and reconciliation following a life‐changing event from the perspectives of individuals experiencing the event and their families. Methods We searched six bibliographic databases for primary qualitative evidence exploring the views of individuals who have experienced a life‐changing event, and/or their family or carers, of redress or reconciliation processes. This was supplemented with targeted database searches, forward and backward citation chasing and searches of Google Scholar and relevant websites. Title and abstract and full‐text screening were undertaken independently by two reviewers. Data extraction and quality appraisal were conducted by one reviewer and checked by a second. We used a best‐fit framework synthesis approach, drawing upon procedural and restorative justice concepts. Findings Fifty‐three studies (61 papers) were eligible for inclusion. Forty‐one studies (47 papers) were included in the synthesis, from which we identified four themes. Three themes ‘Transparency’, ‘Person‐centered’ and ‘Trustworthy’ represent the procedural elements required to support a fair and objective process. The fourth, ‘Restorative justice’ encapsulates how a fair process feels to those who have experienced a life‐changing event. This theme highlights the importance of an empathic relationship between the different parties involved in the redress‐reconciliation process and the significance of being able to engage in meaningful action. Conclusion Our findings highlight the procedural aspects and context of redress‐reconciliation processes required to ensure that the process and outcomes are experienced as fair. These criteria may be applied to the processes used to investigate both recent and historical patient safety events. Public Contribution One member of the public affiliated with the Exeter Policy Research Programme Evidence Review Facility helped develop the review protocol. Two people with experience of medically life‐changing events provided insight which corroborated our findings and identified important limitations of the evidence included in this review.

Abstract Background Affirming socio-cultural settings are essential for protecting the mental health and wellbeing of lesbian, bisexual or pansexual, trans and gender diverse, asexual and queer (LGBTQA +) youth. However, limited research has explored the role of affirming educational and workplace settings, as reported by LGBTQA + youth themselves, with respect to their mental health and wellbeing. Moreover, existing research maintains a focus on mitigating poor mental health outcomes, with little attention to positive wellbeing outcomes among LGBTQA + youth. Methods Using data from the largest national survey of LGBTQA + youth aged 14–21 in Australia, multivariable regression analyses were conducted to explore associations between affirming educational and workplace settings and psychological distress and subjective wellbeing among 4,331 cisgender and 1,537 trans and gender diverse youth. Additionally, a series of multivariable regression analyses were conducted to explore individual sociodemographic traits that are associated with reporting affirming educational or workplace settings. Results Both cisgender and trans or gender diverse participants who reported that their education institution or workplace were affirming of their LGBTQA + identity reported lower levels of psychological distress as well as higher levels of subjective happiness. Additionally, affirming environments were not experienced equally across all subsections of LGBTQA + youth, with reporting of an affirming educational or workplace setting differing most noticeably across gender, type of educational institution and residential location. Conclusion The findings demonstrate that affirming educational and workplace settings can result not only in better mental health, but also greater levels of subjective happiness among LGBTQA + youth. The outcomes illustrate the importance of ensuring all LGBTQA + youth are afforded the opportunity to thrive in environments where they feel validated and confident to express their identities. The findings further highlight a need to target education institutions and workplaces to ensure the implementation of policies and practices that promote not just inclusion of LGBTQA + youth but affirmation of their identities.

Abstract Background The mental health and wellbeing of care-experienced children and young people (i.e. foster care, kinship care, residential care) is poorer than non-care-experienced populations. The Care-experienced cHildren and young people’s Interventions to improve Mental health and wEll-being outcomes Systematic review (CHIMES) aimed to synthesise the international evidence base for interventions targeting subjective wellbeing, mental health and suicide amongst care-experienced young people aged ≤ 25 years. Methods For the first phase of the review, we constructed an evidence map identifying key clusters and gaps in interventions and evaluations. Studies were identified through 16 electronic databases and 22 health and social care websites, in addition to expert recommendations, citation tracking and screening of relevant systematic reviews. We charted interventions and evaluations with a summary narrative, tables and infographics. Results In total, 64 interventions with 124 associated study reports were eligible. The majority of study reports were from the USA (n = 77). Interventions primarily targeted children and young people’s skills and competencies (n = 9 interventions), the parental functioning and practices of carers (n = 26), or a combination of the two (n = 15). While theoretically under-specified, interventions were largely informed by theories of Attachment, Positive Youth Development, and Social Learning Theory. Current evaluations prioritised outcomes (n = 86) and processes (n = 50), with a paucity of study reports including theoretical descriptions (n = 24) or economic evaluations (n = 1). Interventions most frequently targeted outcomes related to mental, behavioural or neurodevelopmental disorders, notably total social, emotional and behavioural problems (n = 48 interventions) and externalising problem behaviours (n = 26). There were a limited number of interventions targeting subjective wellbeing or suicide-related outcomes. Conclusions Future intervention development might focus on structural-level intervention theories and components, and target outcomes related to subjective wellbeing and suicide. In accordance with current methodological guidance for intervention development and evaluation, research needs to integrate theoretical, outcome, process and economic evaluation in order to strengthen the evidence base. Systematic review registration PROSPERO CRD42020177478.

Abstract Background Violence against adolescents is a universal reality, with severe individual and societal costs. There is a critical need for scalable and effective violence prevention strategies such as parenting programmes, particularly in low- and middle-income countries where rates of maltreatment are highest. Digital interventions may be a scalable and cost-effective alternative to in-person delivery, yet maximising caregiver engagement is a substantial challenge. This trial employs a cluster randomised factorial experiment and a novel mixed-methods analytic approach to assess the effectiveness, cost-effectiveness, and feasibility of intervention components designed to optimise engagement in an open-source parenting app, ParentApp for Teens. The app is based on the evidence-based Parenting for Lifelong Health for Teens programme, developed collaboratively by academic institutions in the Global South and North, the WHO, and UNICEF. Methods/design Sixteen neighbourhoods, i.e., clusters, will be randomised to one of eight experimental conditions which consist of any combination of three components (Support: self-guided/moderated WhatsApp groups; App Design: sequential workshops/non-sequential modules; Digital Literacy Training: on/off). The study will be conducted in low-income communities in Tanzania, targeting socioeconomically vulnerable caregivers of adolescents aged 10 to 17 years (16 clusters, 8 conditions, 640 caregivers, 80 per condition). The primary objective of this trial is to estimate the main effects of the three components on engagement. Secondary objectives are to explore the interactions between components, the effects of the components on caregiver behavioural outcomes, moderators and mediators of programme engagement and impact, and the cost-effectiveness of components. The study will also assess enablers and barriers to engagement qualitatively via interviews with a subset of low, medium, and high engaging participants. We will combine quantitative and qualitative data to develop an optimised ParentApp for Teens delivery package. Discussion This is the first known cluster randomised factorial trial for the optimisation of engagement in a digital parenting intervention in a low- and middle-income country. Findings will be used to inform the evaluation of the optimised app in a subsequent randomised controlled trial. Trial registration Pan African Clinical Trial Registry, PACTR202210657553944. Registered 11 October 2022, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=24051 .

Abstract Background Healthcare-based Independent Domestic Violence Advisors (hIDVA) are evidence-based programmes that provide emotional and practical support to service users experiencing domestic abuse. hIDVA programmes are found to improve health outcomes for service users and are increasingly delivered across a range of healthcare settings. However, it is unclear how hIDVA programmes are implemented across maternity services and the key facilitators and barriers to their implementation. The aim of this study was to identify; how many English National Health Service (NHS) Trusts with maternity services have a hIDVA programme; which departments within the Trust they operate in; what format, content, and variation in hIDVA programmes exist; and key facilitators and barriers of implementation in maternity services. Methods A national survey of safeguarding midwives (Midwives whose role specifically tasks them to protect pregnant women from harm including physical, emotional, sexual and financial harm and neglect) within all maternity services across England; descriptive statistics were used to summarise responses. A World Café event (a participatory method, which aims to create a café atmosphere to facilitate informal conversation) with 38 national key stakeholders to examine barriers and facilitators to hIDVA programme implementation. Results 86/124 Trusts (69%) with a maternity service responded to the survey; 59(69%) of respondents reported that they had a hIDVA programme, and 47(55%) of the hIDVA programmes operated within maternity services. Key facilitators to implementation of hIDVA programmes included training of NHS staff about the hIDVA role and regular communication between Trust staff and hIDVA staff; hIDVA staff working directly from the Trust; co-creation of hIDVA programmes with experts by experience; governance and middle- and senior-management support. Key barriers included hIDVA staff having a lack of access to a private space for their work, insecure funding for hIDVA programmes and issues with recruitment and retention of hIDVA staff. Conclusions Despite hIDVA programmes role in improving the health outcomes of service users experiencing domestic abuse, increased funding and staff training is needed to successfully implement hIDVA staff in maternity services. Integrated Care Board commissioning of acute and mental health trust services would benefit from ensuring hIDVA programmes and clinician DVA training are prioritised.

Abstract Background Opportunities for social connection between generations have diminished over the last few decades around the world as a result of changes in the way that we live and work. The COVID‐19 pandemic has exacerbated loneliness for many with young and old being kept apart for safety. The Public Health England prevention concordat for better mental health (Office for Health Improvement and Disparities) aims to bring a prevention‐focused approach to improving public mental health. The concordat promotes evidence‐based planning and commissioning to increase the impact on reducing health inequalities using sustainable and cost‐effective interventions that impact on the wider determinants of mental health and wellbeing for children and young people and older people. Intergenerational activities could provide an opportunity to support both populations. In 2023, we produced an evidence and gap map to illustrate the amount and variety of research on intergenerational interventions and the gaps in research that still exist in this area. The review conducted here is based on the evidence in that map. Objectives This systematic review examines the impact of intergenerational interventions on the wellbeing and mental health of older people and identifies areas for future research as well as key messages for service commissioners. Search Methods We searched an evidence and gap map published in 2022 (comprehensive searches conducted July 2021 and updated June 2023) to identify randomised controlled trials of intergenerational interventions that report mental health and wellbeing outcomes for older people. Selection Criteria Randomised controlled trials of intergenerational interventions that involved unrelated younger and older people with at least one skipped generation between them and reported mental health or wellbeing outcomes for older people were included in this review. Data Collection and Analysis We used standard methodological procedures expected by The Campbell Collaboration. We conducted data extraction and Cochrane risk of bias assessments in EPPI reviewer. Where data allowed meta‐analyses were conducted in STATA. Main Results This review includes 14 trials from six different countries. The trials had some important methodological weaknesses. Interventions were mainly delivered in‐person and often in groups. They included visiting programmes, school volunteering programmes, music‐based interventions and task‐oriented interventions such as activities set in a multigenerational park, reminiscing activities, aggression management programmes, learning a language, making local environmental changes and in‐school project work. Intergenerational interventions showed a small positive trend towards improving self‐esteem (effect size [ES]: 0.33, 95% confidence interval [CI]: −0.35, 1.01) and depression (ES: 0.19, 95% CI: −0.23, 0.60) for older people participating. However, due to the small study sizes and low number of studies available, we cannot be confident about any effects. The results for other mental health and wellbeing outcomes are reported but due to little overlap in similar assessments across the studies, we could not combine them to assess the strength of evidence. There were no data about social isolation, spiritual health or sense of community. There are no long‐term studies and no data on equity. We still know very little about what works and how or why. Whilst some interventions do use theories and logic to inform their development others do not. More exploration of this is needed. Authors’ Conclusions Commissioners and intervention developers should ensure interventions provide sufficient theoretical evidence for the logic behind the proposed intervention and should improve their consideration of equity within the interventions Research on intergenerational interventions need more consistent and agreed measures for reporting outcomes including community outcomes (core outcome sets). More understanding is needed on how best to measure ‘community’ outcomes. Research on intergenerational interventions should measure outcomes for BOTH the older and younger population engaged in the intervention—these may or may not be the same outcomes reflected in both populations. Further research is needed on the long‐term impact of interventions on outcomes (whether participants need to keep being involved in an ‘intervention’ to continue to benefit) and sustainability of interventions beyond the initial funding of the research project. Supporting this our stakeholders highlighted that interventions that are initiated for research and then end (usually within a year) are not helpful.

Abstract Background Addressing persistent and pervasive health inequities is a global moral imperative, which has been highlighted and magnified by the societal and health impacts of the COVID-19 pandemic. Observational studies can aid our understanding of the impact of health and structural oppression based on the intersection of gender, race, ethnicity, age and other factors, as they frequently collect this data. However, the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guideline, does not provide guidance related to reporting of health equity. The goal of this project is to develop a STROBE-Equity reporting guideline extension. Methods We assembled a diverse team across multiple domains, including gender, age, ethnicity, Indigenous background, disciplines, geographies, lived experience of health inequity and decision-making organizations. Using an inclusive, integrated knowledge translation approach, we will implement a five-phase plan which will include: (1) assessing the reporting of health equity in published observational studies, (2) seeking wide international feedback on items to improve reporting of health equity, (3) establishing consensus amongst knowledge users and researchers, (4) evaluating in partnership with Indigenous contributors the relevance to Indigenous peoples who have globally experienced the oppressive legacy of colonization, and (5) widely disseminating and seeking endorsement from relevant knowledge users. We will seek input from external collaborators using social media, mailing lists and other communication channels. Discussion Achieving global imperatives such as the Sustainable Development Goals (e.g., SDG 10 Reduced inequalities, SDG 3 Good health and wellbeing) requires advancing health equity in research. The implementation of the STROBE-Equity guidelines will enable a better awareness and understanding of health inequities through better reporting. We will broadly disseminate the reporting guideline with tools to enable adoption and use by journal editors, authors, and funding agencies, using diverse strategies tailored to specific audiences.

Abstract Background A relationship between smoking and interpersonal influences has been well established within the literature. There have been cultural shifts in denormalisation and a reduction in tobacco smoking in many countries. Hence there is a need to understand social influences on adolescents’ smoking across smoking normalisation contexts. Methods The search was conducted in July 2019 and updated in March 2022 within 11 databases and secondary sources. Search terms included schools, adolescents, smoking, peers, social norms and qualitative research. Screening was conducted by two researchers independently and in duplicate. Study quality was assessed using the eight-item Evidence for Policy and Practice Information and Co-ordinating Centre (EPPI-centre) tool for the appraisal of qualitative studies. Results were synthesised using a meta-narrative lens for meta-ethnography and compared across smoking normalisation contexts. Results Forty one studies were included and five themes were developed, mapping onto the socio ecological model. The social processes by which adolescents take up smoking differed according to a mixture of school type, peer group structure and the smoking culture within the school, as well as the wider cultural context. Data available from smoking denormalised contexts, described changes in social interactions around smoking to cope with its stigmatisation. This was manifested through i) direct peer influence, whereby subtle techniques were employed, ii) group belonging whereby smoking was less likely to be seen as a key determinant of group membership and smoking was less commonly reported to be used as a social tool, and iii) popularity and identity construction, whereby smoking was perceived more negatively in a denormalised context, compared with a normalised context. Conclusions This meta-ethnography is the first study to demonstrate, drawing on international data, that peer processes in adolescent smoking may undergo changes as smoking norms within society change. Future research should focus on understanding differences across socioeconomic contexts, to inform the adaptation of interventions.

Abstract Background Whole-school interventions go beyond classroom health education to modify the school environment to promote health. A sub-set aim to promote student commitment to school to reduce substance use and violence (outcomes associated with low commitment). It is unclear what factors influence implementation of such interventions. Methods We conducted a systematic review including synthesis of evidence from process evaluations examining what factors affect implementation. Meta-ethnographic synthesis was informed by May’s General Theory of Implementation. Results Sixteen reports, covering 13 studies and 10 interventions were included in our synthesis. In terms of May’s concept of ‘sense-making’, we found that school staff were more likely to understand what was required in implementing an intervention when provided with good-quality materials and support. Staff could sometimes wilfully or unintentionally misinterpret interventions. In terms of May’s concept of ‘cognitive participation’, whereby staff commit to implementation, we found that lack of intervention adaptability could in particular undermine implementation of whole-school elements. Interventions providing local data were reported as helping build staff commitment. School leaders were more likely to commit to an intervention addressing an issue they already intended to tackle. Collaborative planning groups were reported as useful in ensuring staff ‘collective action’ (May’s term for working together) to enact interventions. Collective action was also promoted by the presence of sufficient time, leadership and relationships. Implementation of whole-school interventions took time to build. Considering May’s concept of ‘reflexive monitoring’ (formal or informal review of progress), this was important in assessing and enhancing implementation. ‘Quick wins’ could help maintain collective impetus to implement further intervention activities. Conclusion We identified novel factors influencing implementation of whole-school elements such as: local adaptability of interventions; providing local data to build commitment; interventions addressing an issue already on school leaders’ agenda; collaborative planning groups; and ‘reflexive monitoring’ as an explicit intervention component.

Abstract This is the protocol for a Campbell systematic review. The objectives are as follows: This systematic review will examine the impact of intergenerational interventions on the mental health and wellbeing of older people and will identify areas for future research as well as key messages for service commissioners.

Abstract Background The healthy context paradox, originally described with respect to school-level bullying interventions, refers to the generation of differences in mental wellbeing amongst those who continue to experience bullying even after interventions successfully reduce victimisation. Using data from the INCLUSIVE trial of restorative practice in schools, we relate this paradox to the need to theorise potential harms when developing interventions; formulate the healthy context paradox in a more general form defined by mediational relationships and cluster-level interventions; and propose two statistical models for testing the healthy context paradox informed by multilevel mediation methods, with relevance to structural and individual explanations for this paradox. Methods We estimated two multilevel mediation models with bullying victimisation as the mediator and mental wellbeing as the outcome: one with a school-level interaction between intervention assignment and the mediator; and one with a random slope component for the student-level mediator-outcome relationship predicted by school-level assignment. We relate each of these models to contextual or individual-level explanations for the healthy context paradox. Results Neither model suggested that the INCLUSIVE trial represented an example of the healthy context paradox. However, each model has different interpretations which relate to a multilevel understanding of the healthy context paradox. Conclusions Greater exploration of intervention harms, especially when those accrue to population subgroups, is an essential step in better understanding how interventions work and for whom. Our proposed tests for the presence of a healthy context paradox provide the analytic tools to better understand how to support development and implementation of interventions that work for all groups in a population. Trial registration Current Controlled Trials, ISRCTN10751359 .

Abstract Background Whilst prevalence of youth smoking in middle and high income countries has decreased, inequality has prevailed. The introduction of legislation regulating tobacco use in public spaces varies across countries, impacting the tobacco control context. Thus reviewing our knowledge of how social networks may influence smoking differently within different contexts is required to facilitate the development of context-specific interventions. Methods The search, conducted on 31st May 2019, included the following smoking-related terms; schools, adolescents, peers and social networks. Inclusion and exclusion criteria were applied throughout the title and abstract screening and full text screening. Quality assessment and synthesis followed. Studies were narratively synthesised to identify changes according to legislative context. This synthesis was conducted separately for findings relating to three categories: socioeconomic status; social selection and influence; and network position. Results Thirty studies were included. Differences in the relationship between network characteristics and smoking according to socioeconomic status were measured in five out of fifteen studies in Europe. Results varied across studies, with differences in network characteristics and their association with smoking varying both between schools of a differing and those of a similar socioeconomic composition. For studies conducted both before and after the introduction of comprehensive smoking legislation, the evidence for selection processes was more consistent than influence, which varied according to reciprocity. Findings showed that isolates were more likely to smoke and in-degree and out-degree centrality were related to smoking both before and after the introduction of legislation. The relationship between popularity and smoking was contingent on school level smoking prevalence in studies conducted before the introduction of legislation, but not after. Conclusions Overall, effects according to socioeconomic status were underreported in the included studies and no consistent evidence of change after the introduction of a comprehensive smoking ban was observed. Further network analyses are required using more recent data to obtain a comprehensive understanding of how network processes may influence smoking differently according to socioeconomic status, and how adaptation could be used to enhance intervention effectiveness. Systematic review registration International Prospective Register of Systematic Reviews (PROSPERO) registration number: CRD42019137358 .

Abstract We previously proposed that realist randomised controlled trials could be used to evaluate how, for whom and under what conditions complex interventions can be used to activate mechanisms to improve health. While this idea was accepted by some, it was also met with resistance, particularly from some realist evaluators who believe that trials are inextricably positivist and dependent on constant conjunctions to understand causation, and that realist trials are unfeasible because participants and contexts will be insufficiently diverse to enable the testing of context-mechanism-outcome configurations. In this paper, we reflect on analyses of qualitative and quantitative data from the Initiating Change Locally in Bullying and Aggression through the School Environment (INCLSUIVE) trial, and whether these are useful and aligned with realism. We summarise the concerns expressed by realists and reflect on the philosophical and practical challenges that we encountered and whether or not they are related to the trial’s design. Finally, we reflect on the trial’s weaknesses and highlight areas that future researchers might consider when running realist trials. We conclude that realist randomised controlled trials are philosophically coherent, practically feasible, and can produce nuanced findings.

Abstract Aims Preventing the occurrence of depression/anxiety and suicide during adolescence can lead to substantive health gains over the course of an individual person’s life. This study set out to identify the expected population-level costs and health impacts of implementing universal and indicated school-based socio-emotional learning (SEL) programs in different country contexts. Methods A Markov model was developed to examine the effectiveness of delivering universal and indicated school-based SEL programs to prevent the onset of depression/anxiety and suicide deaths among adolescents. Intervention health impacts were measured in healthy life years gained (HLYGs) over a 100-year time horizon. Country-specific intervention costs were calculated and denominated in 2017 international dollars (2017 I$) under a health systems perspective. Cost-effectiveness findings were subsequently expressed in terms of I$ per HLYG. Analyses were conducted on a group of 20 countries from different regions and income levels, with final results aggregated and presented by country income group – that is, low and lower middle income countries (LLMICs) and upper middle and high-income countries (UMHICs). Uncertainty and sensitivity analyses were conducted to test model assumptions. Results Implementation costs ranged from an annual per capita investment of I$0.10 in LLMICs to I$0.16 in UMHICs for the universal SEL program and I$0.06 in LLMICs to I$0.09 in UMHICs for the indicated SEL program. The universal SEL program generated 100 HLYGs per 1 million population compared to 5 for the indicated SEL program in LLMICs. The cost per HLYG was I$958 in LLMICS and I$2,006 in UMHICs for the universal SEL program and I$11,123 in LLMICs and I$18,473 in UMHICs for the indicated SEL program. Cost-effectiveness findings were highly sensitive to variations around input parameter values involving the intervention effect sizes and the disability weight used to estimate HLYGs. Conclusions The results of this analysis suggest that universal and indicated SEL programs require a low level of investment (in the range of I$0.05 to I$0.20 per head of population) but that universal SEL programs produce significantly greater health benefits at a population level and therefore better value for money (e.g., less than I$1,000 per HLYG in LLMICs). Despite producing fewer population-level health benefits, the implementation of indicated SEL programs may be justified as a means of reducing population inequalities that affect high-risk populations who would benefit from a more tailored intervention approach.

Abstract Background Positive Choices is a whole-school social marketing intervention to promote sexual health among secondary school students. Intervention comprises school health promotion council involving staff and students coordinating delivery; student survey to inform local tailoring; teacher-delivered classroom curriculum; student-run campaigns; parent information; and review of sexual/reproductive health services to inform improvements. This trial builds on an optimisation/pilot RCT study which met progression criteria, plus findings from another pilot RCT of the Project Respect school-based intervention to prevent dating and relationship violence which concluded such work should be integrated within Positive Choices. Young people carry a disproportionate burden of adverse sexual health; most do not report competence at first sex. Relationships and sex education in schools can contribute to promoting sexual health but effects are small, inconsistent and not sustained. Such work needs to be supplemented by ‘whole-school’ (e.g. student campaigns, sexual health services) and ‘social marketing’ (harnessing commercial marketing to social ends) approaches for which there is good review-level evidence but not from the UK. Methods We will conduct a cluster RCT across 50 schools (minimum 6440, maximum 8500 students) allocated 1:1 to intervention/control assessing outcomes at 33 months. Our primary outcome is non-competent first sex. Secondary outcomes are non-competent last sex, age at sexual debut, non-use of contraception at first and last sex among those reporting heterosexual intercourse, number of sexual partners, dating and relationship violence, sexually transmitted infections, and pregnancy and unintended pregnancy for girls and initiation of pregnancy for boys. We will recruit 50 school and undertake baseline surveys by March 2022; implement the intervention over the 2022–2024 school years and conduct the economic and process evaluations by July 2024; undertake follow-up surveys by December 2024; complete analyses, all patient and policy involvement and draft the study report by March 2025; and engage in knowledge exchange from December 2024. Discussion This trial is one of a growing number focused on whole-school approaches to public health in schools. The key scientific output will be evidence about the effectiveness, costs and potential scalability and transferability of Positive Choices. Trial registration ISRCTN No: ISRCTN16723909 . Trial registration summary: Date:. Funded by: National Institute for Health Research Public Health Research Programme (NIHR131487). Sponsor: LSHTM. Public/scientific contact: Chris Bonell. Public title: Positive Choices trial. Scientific title: Phase-III RCT of Positive Choices: a whole-school social marketing intervention to promote sexual health and reduce health inequalities. Countries of recruitment: UK. Intervention: Positive Choices. Inclusion criteria: Students in year 8 (age 12–13 years) at baseline deemed competent by schools to participate in secondary schools excluding pupil referral units, schools for those with special educational needs and disabilities, and schools with ‘inadequate’ Ofsted inspections. Study type: interventional study with superiority phase III cluster RCT design. Enrollment: 1/9/21-31/3/22. Sample size: 50 schools and 6440–8500 students. Recruitment status: pending. Primary outcome: binary measure of non-competent first sex. Secondary outcomes: non-competent last sex; age at sexual debut; non-use of contraception at first and last sex; number of sexual partners; dating and relationship violence (DRV) victimisation; sexually transmitted infections; pregnancy and unintended pregnancy for girls and initiation of pregnancy for boys using adapted versions of the RIPPLE measures. Ethics review: LSHTM research ethics committee (reference 26411). Completion data: 1/3/25. Sharing statement: Data will be made available after the main trial analyses have been completed on reasonable request from researchers with ethics approval and a clear protocol. Amendments to the protocol will be communicated to the investigators, sponsor, funder, research ethics committee, trial registration and the journal publishing the protocol. Amendments affecting participants’ experience of the intervention or important amendments affecting the overall design and conduct of the trial will be communicated to participants.

Abstract Approaches for rapid reviews that focus on streamlining systematic review methods are not always suitable for exploring complex policy questions, as developing and testing theories to explain these complexities requires configuring diverse qualitative, quantitative, and mixed methods studies. Our objective was therefore to provide a guide to selecting approaches for rapidly (i.e., within days to months) addressing complex questions related to health policy and system issues. We provide a two-stage, transdisciplinary collaborative process to select a rapid review approach to address complex policy questions, which consists of scoping the breadth and depth of the literature and then selecting an optimal approach to synthesis. The first stage (scoping the literature) begins with a discussion with the stakeholders requesting evidence to identify and refine the question for the review, which is then used to conduct preliminary searches and conceptually map the documents identified. In the second stage (selection of an optimal approach), further stakeholder consultation is required to refine and tailor the question and approach to identifying relevant documents to include. The approach to synthesizing the included documents is then guided by the final question, the breadth and depth of the literature, and the time available and can include a static or evolving conceptual framework to code and analyze a range of evidence. For areas already covered extensively by existing systematic reviews, the focus can be on summarizing and integrating the review findings, resynthesizing the primary studies, or updating the search and reanalyzing one or more of the systematic reviews. The choice of approaches for conducting rapid reviews is intertwined with decisions about how to manage projects, the amount of work to be done, and the knowledge already available, and our guide offers support to help make these strategic decisions.

Abstract Background Positive Choices is a whole-school social-marketing intervention to promote sexual health among secondary school students. Intervention comprises the following: school health promotion council involving staff and students coordinating delivery, student survey to inform local tailoring, teacher-delivered classroom curriculum, student-run campaigns, parent information and review of sexual/reproductive health services to inform improvements. This trial builds on an optimisation/pilot-RCT study which met progression criteria, plus findings from another pilot RCT of the Project Respect school-based intervention to prevent dating and relationship violence which concluded such work should be integrated within Positive Choices. Young people carry a disproportionate burden of adverse sexual health; most do not report competence at first sex. Relationships and sex education in schools can contribute to promoting sexual health but effects are small, inconsistent and not sustained. Such work needs to be supplemented by ‘whole-school’ (e.g. student campaigns, sexual health services) and ‘social marketing’ (harnessing commercial marketing to social ends) approaches for which there is good review-level evidence but not from the UK. Methods We will conduct a cluster RCT across 50 schools (minimum 6440, maximum 8500 students) allocated 1:1 to intervention/control assessing outcomes at 33 months. Our primary outcome is non-competent first sex. Secondary outcomes are non-competent last sex, age at sexual debut, non-use of contraception at first and last sex among those reporting heterosexual intercourse, number of sexual partners, dating and relationship violence, sexually transmitted infections and pregnancy and unintended pregnancy for girls and initiation of pregnancy for boys. We will recruit 50 school and undertake baseline surveys by March 2022, implement the intervention over the 2022–2024 school years and conduct the economic and process evaluations by July 2024; undertake follow-up surveys by December 2024; complete analyses, all patient and policy involvement and draft the study report by March 2025 and engage in knowledge exchange from December 2024. Discussion This trial is one of a growing number focused on whole-school approaches to public health in schools. The key scientific output will be evidence about the effectiveness, costs and potential scalability and transferability of Positive Choices. Trial registration ISRCTN No: ISRCTN16723909 . Registered on 3 September 2021.

Abstract Background Women with previous gestational diabetes have an increased risk of developing type 2 diabetes later in life. Recommendations therefore urge these women to participate in follow-up screening, 4–12 weeks postpartum and every 1–3 years thereafter. We sought to theorize how reminder interventions to support early detection of diabetes work, for whom, and in what circumstances. Methods We used a method informed by realist review and synthesis. A systematic, iterative search in six electronic databases (PubMed, MEDLINE Ovid, The Cochrane Library, CINAHL, EMBASE) had a primary focus on experimental intervention studies and included additional information in relation to identified intervention studies. Analysis inductively identified context-mechanism-outcome configurations present in the evidence. Results We located 16 articles eligible for inclusion. A cross-case comparison identified seven grouped context-mechanism-outcome configurations leading to intervention mechanisms relating to changes in women’s reasoning and behavior. Configurations were thematically ordered in relation to Systems Resources, Women’s Circumstances, and Continuity of Care. These were mapped onto a socio-ecological model and discussed according to identified middle-range theories. Conclusion Our findings adds to the body of evidence, that reminders have the potential to be effective in increasing participation in the recommended follow-up screening. Our study may assist researchers and policy and decision makers to analyze and judge if reminders are feasible and/or likely to succeed in their specific context. Further research into the perspective of socially disadvantaged and overweight women is needed to avoid unintended consequences such as social inequality in service use and stigmatization in future programs.

Abstract Background Adolescent HIV and pregnancy rates in Southern Africa are amongst the highest in the world. Despite decades of sexual and reproductive health (SRH) programming targeting adolescents, recent trends suggest there is a continued need for interventions targeting condom use for this age group. Methods This review synthesises evidence from qualitative studies that describe the determinants of condom use among adolescents in Southern Africa. We conducted systematic searches in four databases. Data were extracted, appraised for quality and analysed using a ‘best-fit’ framework synthesis approach. Results We coded deductively findings from 23 original studies using an a priori framework and subsequently conducted thematic analysis. Synthesised findings produced six key themes relating to: 1) pervasive unequal gender norms and restrictive masculinities favouring male sexual decision-making and stigmatising condom use in committed relationships; 2) other social norms reflecting negative constructions of adolescent sexuality and non-traditional family planning; 3) economic and political barriers including poverty and a lack of policy support for condom use; 4) service-level barriers including a lack of youth-friendly SRH services and comprehensive sex education in schools; 5) interpersonal barriers and facilitators including unequal power dynamics in sexual partnerships, peer influences and encouraging condoning condom use, and inadequate communication about SRH from parents/caregivers; and 6) negative attitudes and beliefs about condoms and condom use among adolescents. A conceptual model was generated to describe determinants of condom use, illustrating individual-, interpersonal- and structural-level barriers and facilitating factors. Conclusion SRH programming targeting barriers and facilitators of condom use at multiple levels is recommended in Southern Africa. We present a multilevel integrated model of barriers and facilitators to guide adolescent SRH decision-making, programme planning and evaluation. Given the existence of multilevel barriers and facilitators, interventions should, likewise, take a multilevel approach that incorporates locally relevant understanding of the individual-, interpersonal- and structural-level barriers and facilitators to condom use among adolescents in the region.

Abstract Objective Family-based multi-component weight management programmes are recommended for adolescents with obesity in England and Wales, however, these programmes suffer from poor uptake and high attrition rates. This study aimed to gather the views of professional stakeholders in a UK weight management programme to identify potential areas to target to improve engagement and success for such programmes. Results Semi-structured interviews were conducted with those involved in the commissioning, referral, coordination or delivery of a weight management programme (n = 11). Interviews were analysed using qualitative content analysis. Three main categories developed: professional support, tailoring and intervention content. Participants recognised the importance of support from experienced professionals, as well as family and peers. There was agreement that longer-term support was needed for adolescents with obesity; suggestions included integrating follow-up support with schools and leisure services. Emotional and psychological support must be prioritised. Having a variety of delivery modes, such as group and one to one, particularly in the home environment, were recommended. Stakeholders agreed that weight management programmes for adolescents need to be more proactive at incorporating technology. By acting on the views of those that work closely with adolescents, engagement with weight management programmes may be improved.

Abstract Background Conceptual and theoretical links between politics and public health are longstanding. Internationally comparative systematic review evidence has shown links between four key political exposures – the welfare state, political tradition, democracy and globalisation – on population health outcomes. However, the pathways through which these influences may operate have not been systematically appraised. Therefore, focusing on child and maternal health outcomes, we present a realist re-analysis of the dataset from a recent systematic review. Methods The database from a recent systematic review on the political determinants of health was used as the data source for this realist review. Included studies from the systematic review were re-evaluated and those relating to child and/or maternal health outcomes were included in the realist synthesis. Initial programme theories were generated through realist engagement with the prior systematic review. These programme theories were adjudicated and refined through detailed engagement with the evidence base using a realist re-synthesis involving two independent reviewers. The revised theories that best corresponded to the evidence base formed the final programme theories. Results Out of the 176 included studies from the systematic review, a total of 67 included child and/or maternal health outcomes and were included in the realist re-analysis. Sixty-three of these studies were ecological and data were collected between 1950 and 2014. Six initial programme theories were generated. Following theory adjudication, three theories in revised form were supported and formed the final programme theories. These related to a more generous welfare state leading to better child and maternal health especially in developed countries through progressive social welfare policies, left-of-centre political tradition leading to lower child mortality and low birth weight especially in developed countries through greater focus on welfare measures, and increased globalisation leading to greater child and infant mortality and youth smoking rates in LMECs through greater influence of multinational corporations and neoliberal trade organisations. Conclusion We present a realist re-analysis of a large systematically identified body of evidence on how four key political exposures – the welfare state, democracy, political tradition and globalisation – relate to child and maternal health outcomes. Three final programme theories were supported.

Abstract Background Sexual risk, substance use, and mental ill health constitute a syndemic of co-occurring, mutually reinforcing epidemics amongst men who have sex with men (MSM). Developed since 1995, e-health interventions offer accessible, anonymous support and can be effective in addressing these outcomes, suggesting the potential value of developing e-health interventions that address these simultaneously amongst MSM. We conducted a systematic review of e-health interventions addressing one or more of these outcomes amongst MSM and in this paper describe the theories of change underpinning relevant interventions, what these offer and how they might complement each other. Methods We identified eligible reports via expert requests, reference-checking and database and Google searches. Results were screened for reports published in 1995 or later; focused on MSM; reporting on e-health interventions providing ongoing support to prevent HIV/STIs, sexual risk behaviour, substance use, anxiety or depression; and describing intervention theories of change. Reviewers assessed report quality, extracted intervention and theory of change data, and developed a novel method of synthesis using diagrammatic representations of theories of change. Results Thirty-three reports on 22 intervention theories of change were included, largely of low/medium-quality. Inductively grouping these theories according to their core constructs, we identified three distinct groupings of theorised pathways. In the largest, the ‘cognitive/skills’ grouping, interventions provide information and activities which are theorised to influence behaviour via motivation/intention and self-efficacy/perceived control. In the ‘self-monitoring’ grouping, interventions are theorised to trigger reflection, self-reward/critique and self-regulation. In the ‘cognitive therapy’ grouping, the theory of change is rooted in cognitive therapy techniques, aiming to reframe negative emotions to improve mental health. Conclusions The synthesised theories of change provide a framework for developing e-health interventions that might holistically address syndemic health problems amongst MSM. Improving reporting on theories of change in primary studies of e-health interventions would enable a better understanding of how they are intended to work and the evidence supporting this. The novel diagrammatic method of theory of change synthesis used here could be used for future reviews where interventions are driven by existing well-defined behaviour and behaviour change theories. Systematic review registration PROSPERO CRD42018110317

Abstract Background Pregnancy and parenthood are known to be high-risk times for mental health. However, less is known about the mental health of pregnant adolescents or adolescent parents. Despite the substantial literature on the risks associated with adolescent pregnancy, there is limited evidence on best practices for preventing poor mental health in this vulnerable group. This systematic review therefore aimed to identify whether psychosocial interventions can effectively promote positive mental health and prevent mental health conditions in pregnant and parenting adolescents. Methods We used the standardized systematic review methodology based on the process outlined in the World Health Organization’s Handbook for Guidelines Development. This review focused on randomized controlled trials of preventive psychosocial interventions to promote the mental health of pregnant and parenting adolescents, as compared to treatment as usual. We searched PubMed/Medline, PsycINFO, ERIC, EMBASE and ASSIA databases, as well as reference lists of relevant articles, grey literature, and consultation with experts in the field. GRADE was used to assess the quality of evidence. Results We included 17 eligible studies (n = 3245 participants). Interventions had small to moderate, beneficial effects on positive mental health (SMD = 0.35, very low quality evidence), and moderate beneficial effects on school attendance (SMD = 0.64, high quality evidence). There was limited evidence for the effectiveness of psychosocial interventions on mental health disorders including depression and anxiety, substance use, risky sexual and reproductive health behaviors, adherence to antenatal and postnatal care, and parenting skills. There were no available data for outcomes on self-harm and suicide; aggressive, disruptive, and oppositional behaviors; or exposure to intimate partner violence. Only two studies included adolescent fathers. No studies were based in low- or middle-income countries. Conclusion Despite the encouraging findings in terms of effects on positive mental health and school attendance outcomes, there is a critical evidence gap related to the effectiveness of psychosocial interventions for improving mental health, preventing disorders, self-harm, and other risk behaviors among pregnant and parenting adolescents. There is an urgent need to adapt and design new psychosocial interventions that can be pilot-tested and scaled with pregnant adolescents and adolescent parents and their extended networks, particularly in low-income settings.

Abstract Background Smoking remains a major public health concern. School-based social networks influence uptake of smoking among peers. During the past two decades, the UK macro-systemic context within which schools are nested and interact with has changed, with anti-smoking norms having become set at a more macro-systemic level. Whilst the overall prevalence of smoking in the UK has decreased, inequality has prevailed. It is plausible that the influence of school-based social networks on smoking uptake may vary according to socioeconomic status. Therefore, this study aims to understand how social influence on smoking among adolescents has changed in line with variance within and between contexts according to time and geography. Methods The following databases will be searched: Medline, PsycINFO, Embase, Applied Social Sciences Index and Abstracts (ASSIA), British Education Index, Sociological abstracts, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Education Resources Information Center (ERIC) and Scopus. Additional searches will include reference checking of key papers, citation tracking, word of mouth and grey literature searches. The search strategies will incorporate terms relating to smoking, adolescents, schools, peers, network analysis and qualitative research. Titles and abstracts and full texts will be independently screened and assessed for quality by at least two researchers. Included studies will be assessed for quality, and data will be extracted for synthesis, including participant characteristics, setting and tobacco control context, study design and methods, analysis and results and conclusions. Quantitative findings will be narratively synthesised, whilst a lines of argument synthesis combined with refutational analysis will be employed to synthesise qualitative data. Both sets of findings will be charted on a timeline to add context to network findings and obtain an enhanced understanding of changes over time. Discussion This protocol is for a mixed methods synthesis of both social network findings, to investigate social structures and qualitative studies, to elicit contextual information. The review will synthesise changes in the context of social influence on adolescent smoking over time and geographically. As context is increasingly recognised as a key source of complexity, this enhanced understanding will help to inform future interventions targeting smoking through social influence. This will help to enhance their relevance to context, subsequent effectiveness and targeting of inequalities. Systematic review registration PROSPERO CRD42019137358

Menstruation is a global public health issue with negative discourses of shame, embarrassment, and disgust. There is growing anecdotal evidence linking negative menstruation experiences at school to absenteeism. This systematic review and line-of-argument synthesis aims to develop a conceptual understanding of menstruation experiences in schools in high-income countries. MEDLINE (Ovid), PsycINFO (Ovid), EMBASE (Ovid), HMIC (Ovid), and ERIC databases were searched. NVivo was used for thematic synthesis and reciprocal translation to generate third-order constructs: overarching themes that interpretatively describe social processes around menstruation in schools. One thousand three hundred and thirty-three studies were screened, with 19 meeting inclusion criteria. Six third-order constructs were identified and integrated into a synthesized line-of-argument illustrating menstrual injustice at school. To ensure menstruating students do not face academic disadvantage because of schools' failure to accommodate menstrual needs, schools should challenge stigma, provide facilities to improve students' capability and confidence to manage menstruation, and provide academic support to menstruating students who miss classes. Future research should explore experiences of period poverty in HIC schools, examining the influence of gender identity, disability, race, and class on menstruation experiences.

Abstract Background Rapid infant weight gain (RIWG) is a very strong predictor of childhood overweight and obesity (COO). Socioeconomic position (SEP) is also related to the risk of COO and parents of different SEP may differ in their reaction to accelerated infant weight gain. Together this could lead to differences in how weight gain and COO risk relate across SEP. This study aimed to analyse possible interaction of SEP and RIWG on COO risk. Methods A register-based longitudinal cohort study followed 19,894 healthy, term infants, born in Denmark between December 2011 and May 2015. Logistic regression models were used to estimate odds ratios (OR) of COO risk at 2 years (22–26 months) of age with 95% confidence intervals (95% CI) for categories of infancy weight gain based on changes in weight-for-age z-scores between 0 and 8–10 months of age (slow ( 0.67–1.34) and very rapid (> 1.34)). Possible multiplicative and additive interaction of SEP (based on household income and maternal education) on the relationship between infancy weight gain and COO were analysed. Results In total, 19.1 and 15.1% experienced rapid or very rapid weight gain, respectively, and 1497 (7.5%) children were classified with COO at follow-up. These prevalences were higher in those with lower levels of SEP. Adjusted OR for COO were 3.09 (95% CI [2.66–3.59]) and 7.58 (95% CI [6.51–8.83]) for rapid and very rapid weight gain, respectively, when household income was included in the model. Results were similar in the model including maternal education. No signs of interactions were detected on a multiplicative scale. Weak signs of additive interaction were present, but these values did not reach significance. Conclusion Both rapid and very rapid weight gain were associated with substantially higher risks of COO but these associations were not modified by SEP. This indicates that promotion of healthy weight gain should take place in all population groups irrespective of their SEP.

Abstract Background A review of therapies for advanced cancers licenced by the EMA between 2009 and 2013 concluded that for more than half of these drugs there was little evidence of overall survival or quality of life benefit. Recent years have witnessed a growing number of licensed second-line pharmacotherapies for advanced/metastatic non-small cell lung cancer (NSCLC). With the aim of gauging patient survival benefit, we conducted a systematic review of randomised controlled trials (RCT) and compared survival outcomes from available licensed treatments for patients with advanced/metastatic NSCLC. Methods RCTs of second/third line treatments in participants with advanced/metastatic NSCLC and negative/low expression of Anaplastic Lymphoma Kinase (ALK) and of Epidermal Growth Factor Receptor (EGFR) were included. We searched electronic databases (MEDLINE; EMBASE; Web of Science) from January, 2000 up to July, 2017. Two or more independent reviewers screened bibliographic records, extracted data, and assessed risk of bias of studies. Published Kaplan Meier plots for OS and PFS along with restricted-mean-survival methods and parametric modelling were used to estimate the survival outcomes as mean number of months of survival. Network meta-analysis was undertaken to rank interventions and to make indirect comparisons. Results We included 11 RCTs with data for 7581 participants that compared nine different drugs. In studies of patients regardless of histology groups, targeted drugs (ramucirumab and nintedanib) yielded small overall survival gains of

Abstract Background Dating and relationship violence (DRV)—intimate partner violence during adolescence—encompasses physical, sexual and emotional abuse. DRV is associated with a range of adverse health outcomes including injuries, sexually transmitted infections, adolescent pregnancy and mental health issues. Experiencing DRV also predicts both victimisation and perpetration of partner violence in adulthood. Prevention targeting early adolescence is important because this is when dating behaviours begin, behavioural norms become established and DRV starts to manifest. Despite high rates of DRV victimisation in England, from 22 to 48% among girls and 12 to 27% among boys ages 14–17 who report intimate relationships, no RCTs of DRV prevention programmes have taken place in the UK. Informed by two school-based interventions that have shown promising results in RCTs in the USA—Safe Dates and Shifting Boundaries—Project Respect aims to optimise and pilot a DRV prevention programme for secondary schools in England. Methods Design: optimisation and pilot cluster RCT. Trial will include a process evaluation and assess the feasibility of conducting a phase III RCT with embedded economic evaluation. Cognitive interviewing will inform survey development. Participants: optimisation involves four schools and pilot RCT involves six (four intervention, two control). All are secondary schools in England. Baseline surveys conducted with students in years 8 and 9 (ages 12–14). Follow-up surveys conducted with the same cohort, 16 months post-baseline. Optimisation sessions to inform intervention and research methods will involve consultations with stakeholders, including young people. Intervention: school staff training, including guidance on reviewing school policies and addressing ‘hotspots’ for DRV and gender-based harassment; information for parents; informing students of a help-seeking app; and a classroom curriculum for students in years 9 and 10, including a student-led campaign. Primary outcome: the primary outcome of the pilot RCT will be whether progression to a phase III RCT is justified. Testing within the pilot will also determine which of two existing scales is optimal for assessing DRV victimisation and perpetration in a phase III RCT. Discussion This will be the first RCT of an intervention to prevent DRV in the UK. If findings indicate feasibility and acceptability, we will undertake planning for a phase III RCT of effectiveness. Trial registration ISRCTN, ISRCTN 65324176. Registered 8 June 2017.

Abstract Background Within increasingly constrained school timetables, interventions that integrate academic and health education to reduce substance use and violence may hold promise as a category of intervention that can positively affect both academic and health outcomes. There are no current systematic reviews exploring the effectiveness of such interventions or factors that affect their implementation. Methods A total of 19 bibliographic databases and 32 websites were searched. References were also extracted from the reference lists of included studies, and experts and authors were contacted to identify relevant studies. We included reports with no restrictions on language or date. References were screened on title/abstract and those not thus excluded were screened on full report. Data extraction and appraisal followed the Critical Appraisal Skills Programme, Evidence for Policy and Practice Information and Co-ordinating Centre and Cochrane tools. Extracted process data were qualitatively meta-synthesised for common themes. Results Seventy-eight thousand four hundred fifty-one unique references were identified, and 62 reports were included. A total of 16 reports (reporting on 15 studies of 12 interventions) evaluated process. Key facilitators of integrated academic and health curricula were supportive senior management and alignment of the intervention with school ethos; a positive teaching environment, including positive perceptions around the ability to be flexible in the adaptation and delivery of integrated academic and health curricula; positive pre-existing student and teacher attitudes towards intervention content; and parental support of interventions, largely through reinforcement of messaging at home. Important barriers were over-burdened teachers, with little time to learn and implement integrated curricula. Conclusion Several useful facilitating and inhibiting factors linked to the implementation of interventions that integrate academic and health education for reduced substance use and/or violence were identified, providing tentative but insightful evidence of context-specific issues that may impact intervention success. However, overall, there is still a considerable gap in our understanding of how to achieve the successful implementation of these interventions.

Abstract Background Schools can play an important role in promoting health. However, many education policies and institutions are increasingly emphasising academic attainment targets, which appear to be diminishing the time available for health education lessons. Interventions that integrate both health and academic learning may present an ideal solution, simultaneously addressing health education and academic development. The theories of change underlying these interventions are therefore of interest, but are poorly studied. Methods A systematic review of evaluations of interventions that integrate academic and health education for reduced substance use and/or violence was carried out. As part of this, reports describing theory were assessed for quality and data extracted. Theoretical data were synthesised within and across individual interventions using reciprocal translation and meta-ethnographic line of argument synthesis to produce an overall theory of change for interventions that integrate health and academic education to prevent substance use and violence. Results Forty-eight reports provided theoretical descriptions of 18 interventions. An overarching theory that emerged was that eroding ‘boundaries’ at multiple and mutually reinforcing levels—by integrating academic and health education, by transforming relationships between teachers and students, by generalising learning from classrooms to the wider school environment and by ensuring consistent messages from schools and families—is intended to lead to the development of a community of engaged students oriented towards pro-social behaviour and away from substance use, violence and other risk behaviours. Conclusions Eroding ‘boundaries’ between health and academic education, teachers and students, classrooms and the wider school and schools and families were seen to be the most critical to establishing new frameworks of family, classroom or school organisation that are conducive to promoting both academic and social-emotional outcomes. Whether such interventions are feasible to implement and effective in reducing risk behaviours will be examined in other reports arising from the review.

Abstract Background We systematically reviewed the comparative effectiveness of injectable beta-interferons (IFN-β) and glatiramer acetate (GA) on annualised relapse rate (ARR), progression and discontinuation due to adverse events (AEs) in RRMS, using evidence from within the drugs’ recommended dosages. Methods We updated prior comprehensive reviews, checked references of included studies, contacted experts in the field, and screened websites for relevant publications to locate randomised trials of IFN-β and GA with recommended dosages in RRMS populations, compared against placebo or other recommended dosages. Abstracts were screened and assessed for inclusion in duplicate and independently. Studies were appraised using the Cochrane risk of bias tool. Rate ratios for ARR, hazard ratios for time to progression, and risk ratios for discontinuation due to AEs were synthesised in separate models using random effects network meta-analysis. Results We identified 24 studies reported in 42 publications. Most studies were at high risk of bias in at least one domain. All drugs had a beneficial effect on ARR as compared to placebo, but not compared to each other, and findings were robust to sensitivity analysis. We considered time to progression confirmed at 3 months and confirmed at 6 months in separate models; while both models suggested that the included drugs were effective, findings were not consistent between models. Discontinuation due to AEs did not appear to be different between drugs. Conclusions Meta-analyses confirmed that IFN-β and GA reduce ARR and generally delay progression as defined in these trials, though there was no clear ‘winner’ across outcomes. Findings are additionally tempered by the high risk of bias across studies, and the use of an impairment/mobility scale to measure disease progression. Future research should consider more relevant measures of disability and, given that most trials have been short-term, consider a longitudinal approach to comparative effectiveness. Review registration PROSPERO CRD42016043278.

Abstract Background Since the introduction of the Teenage Pregnancy Strategy (TPS), England’s under-18 conception rate has fallen by 55%, but a continued focus on prevention is needed to maintain and accelerate progress. The teenage birth rate remains higher in the UK than comparable Western European countries. Previous trials indicate that school-based social marketing interventions are a promising approach to addressing teenage pregnancy and improving sexual health. Such interventions are yet to be trialled in the UK. This study aims to optimise and establish the feasibility and acceptability of one such intervention: Positive Choices. Methods Design: Optimisation, feasibility testing and pilot cluster randomised trial. Interventions: The Positive Choices intervention comprises a student needs survey, a student/staff led School Health Promotion Council (SHPC), a classroom curriculum for year nine students covering social and emotional skills and sex education, student-led social marketing activities, parent information and a review of school sexual health services. Systematic optimisation of Positive Choices will be carried out with the National Children’s Bureau Sex Education Forum (NCB SEF), one state secondary school in England and other youth and policy stakeholders. Feasibility testing will involve the same state secondary school and will assess progression criteria to advance to the pilot cluster RCT. Pilot cluster RCT with integral process evaluation will involve six different state secondary schools (four interventions and two controls) and will assess the feasibility and utility of progressing to a full effectiveness trial. The following outcome measures will be trialled as part of the pilot:1.Self-reported pregnancy and unintended pregnancy (initiation of pregnancy for boys) and sexually transmitted infections,2.Age of sexual debut, number of sexual partners, use of contraception at first and last sex and non-volitional sex3.Educational attainment The feasibility of linking administrative data on births and termination to self-report survey data to measure our primary outcome (unintended teenage pregnancy) will also be tested. Discussion This will be the first UK-based pilot trial of a school-wide social marketing intervention to reduce unintended teenage pregnancy and improve sexual health. If this study indicates feasibility and acceptability of the optimised Positive Choices intervention in English secondary schools, plans will be initiated for a phase III trial and economic evaluation of the intervention. Trial registration ISRCTN registry (ISCTN12524938. Registered 03/07/2017).

An amendment to this paper has been published and can be accessed via the original article.

Background: The mitigation of unfair and avoidable differences in health is an increasing global priority. Observational studies including cohort, cross-sectional and case-control studies tend to report social determinants of health which could inform evidence syntheses on health equity and social justice. However, the extent of reporting and analysis of equity in equity-relevant observational studies is unknown. Methods: We define studies which report outcomes for populations at risk of experiencing inequities as “equity-relevant”. Using a random sampling technique we will identify 320 equity-relevant observational studies published between 1 January 2020 to 27 April 2022 by searching the MEDLINE database. We will stratify sampling by 1) studies in high-income countries (HIC) and low- and middle-income countries (LMIC) according to the World Bank classification, 2) studies focused on COVID and those which are not, 3) studies focused on populations at risk of experiencing inequities and those on general populations that stratify their analyses. We will use the PROGRESS framework which stands for place of residence, race or ethnicity, occupation, gender or sex, religion, education, socioeconomic status, social capital, to identify dimensions where inequities may exist. Using a previously developed data extraction form we will pilot-test on eligible studies and revise as applicable. Conclusions: The proposed methodological assessment of reporting will allow us to systematically understand the current reporting and analysis practices for health equity in observational studies. The findings of this study will help inform the development of the equity extension for the STROBE (Strengthening the Reporting of Observational studies in Epidemiology) reporting guidelines.