Tobacco use is the most significant modifiable risk factor for adverse health outcomes, and early research indicates there are also significant harms associated with vaping. National targets aim to reduce smoking and vaping during pregnancy for Aboriginal and Torres Strait Islander people. While most Aboriginal and Torres Strait Islander people want to quit, cessation is frequently attempted without support, increasing the chance of relapse. Group-based smoking cessation programmes increase quit success by 50%–130% in the general population; however, they have never been evaluated in Aboriginal and/or Torres Strait Islander communities.

The Gulibaa study is an Indigenous-led and community-embedded project that will co-design, implement and evaluate a group-based model of care to support Aboriginal and Torres Strait Islander women to be smoke- and vape-free. Staff of Health Services in New South Wales, Australia, will receive training to deliver a face-to-face group-based smoking and vaping cessation intervention. Aboriginal and/or Torres Strait Islander people who identify as a woman or non-binary, are pregnant or of reproductive age (16 to 49 years), currently smoke or vape at least once per day and are willing to attend the programme are eligible to participate. Up to 500 participants will be recruited. A mixed method evaluation approach will be implemented guided by the RE-AIM framework. Outcomes will include intervention reach, intervention effectiveness (determined primarily by self-reported 7-day point prevalence abstinence at 6 months follow-up), acceptability and feasibility of the intervention, programme fidelity and maintenance and cost effectiveness.

Embedding culturally safe support to quit during pregnancy can result in improved outcomes for both mother and child and immediately improve intergenerational health and well-being. Ethics approval has been provided by the Aboriginal Health and Medical Research Council and the University of Newcastle. Study findings will be disseminated to Aboriginal and Torres Strait Islander communities in ways that are meaningful to them, as well as through Aboriginal health services, key national bodies, relevant state and federal government departments.

ACTRN12625001050448.

Duchenne and Becker muscular dystrophies (DMD and BMD) are devastating conditions characterised by progressive muscle degeneration and weakness. Despite advances in understanding their pathogenetic processes, there is a critical need for reliable biomarkers to aid in patient stratification and inform clinical decision-making, predict disease progression and evaluate therapeutic responses. Several promising protein biomarkers have been investigated as potential diagnostic/prognostic tools, but, to date, this evidence has not been systematically synthesised. We aim to comprehensively and critically review and summarise published studies reporting the use of protein signatures of muscular damage in DMD and BMD.

We will systematically search Ovid MEDLINE (PubMed), OVID Embase, OVID Evidence-Based Medicine Reviews and Cochrane Library to retrieve all relevant articles. For ongoing trials, we will search WHO International clinical trials registry and ClinicalTrials.gov registry. We will include studies that measure circulating and urine levels of established and/or promising protein biomarkers associated with skeletal muscular damage and disease progression, such as creatine kinase, myoglobin, skeletal troponin I fast-twitch (type II), myostatin, creatine/creatinine ratio, creatinine and titin. We will consider randomised controlled trials, observational studies and longitudinal cohort studies with serial sampling, without restrictions on sample size, geographic location or language, while excluding animal and in vitro studies. Two independent reviewers will screen articles for inclusion using predefined eligibility criteria and extract data of retained articles. A third author will be consulted in case of disagreement. The approach recommended by the Agency for Healthcare Research and Quality’s Methods Guide for Effectiveness and Comparative Effectiveness Reviews will be used. The risk of bias and reporting quality will be assessed with standardised scales. The analysis will involve a structured narrative synthesis and evidentiary tables. If a meta-analysis is possible, biomarker data for each outcome will be pooled using random effects models. Subgroup analyses have been planned as a function of age, genetic mutation, disease severity, imaging and clinical assessment, length of the observation and risk of bias.

Ethics approval is not required for this study as no original data will be collected. The findings will be shared through peer-reviewed publications and conference presentations. Additionally, this systematic review will guide the recommendations of the Duchenne Regulatory Science Consortium. This work will provide a rigorous, exhaustive and accessible evidence synthesis to identify candidate biomarkers of potential clinical value. Furthermore, it is expected that these results could be used to facilitate the development of future research strategies and guidelines, inform resource allocation decisions and accelerate the route towards clinical implementation of biomarkers for DMD and BMD.

CRD42024549471. Available from: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42024549471

As care and rehabilitation poststroke are increasingly moving into persons’ home environment, the importance of support from social networks in self-management and rehabilitation has emerged as an important topic for research and practice. While there are instruments used to assess social support and collective efficacy, a clearer scope of the availability and quality of these instruments is needed. This clarification will enable the development of interventions integrating social network perspectives in poststroke rehabilitation.

To assess the availability and quality of instruments assessing social support and collective efficacy, a scoping review will be conducted and reported following the Preferred Reporting Items for Systematic Reviews and Meta-analyses Extension for Scoping Reviews guidelines (PRISMA-ScR). Literature searches conducted between 14 November 2024 and 15 November 2024 in the CINAHL and PubMed/Medline databases resulted in 4631 articles potentially eligible. After removing duplicates, 4121 articles’ titles and abstracts were initially screened. Full-text screening, searches of reference lists and data extraction started in June 2025. Starting August 2025, two reviewers will assess the full texts against the inclusion criteria in Covidence using a coding template. Identified instruments will be appraised following the COSMIN (Consensus-based Standards for the selection of health Measurement INstruments guidelines) and analysed using a narrative descriptive method. Results will be reported in February 2026 according to PRISMA-ScR guidelines.

Ethical approval is not required for this scoping review, as it does not involve primary data. However, this review follows established ethical guidelines and best practices, and included studies will be reviewed to ensure that they received ethical approval and included informed consent. Results from the review will be disseminated through an article in a scientific journal, at relevant conferences and surmised to stroke organisations. A policy brief will be developed for health and social care professionals and policy makers.

Child undernutrition is linked to substantial national economic and health losses in low- and middle-income countries, including Rwanda. Although the causal and contextual factors contributing to chronic malnutrition in children in Rwanda have been explored, the role of the mothers’ mental health has not been fully investigated. This study aims to determine the prevalence of major depressive disorders, generalised anxiety and suicide risk among mothers in Rwanda and to explore their association with child stunting.

This study used a cross-sectional, population-based design.

Participants included children aged 1–36 months (n=601) and their mothers (n=601) in Rwanda’s Northern Province. Mothers’ mental health was assessed using four modules from the Mini International Neuropsychiatric Interview, based on the Diagnostic and Statistical Manual of Mental Disorders. Child anthropometric measurements followed WHO guidelines.

The primary outcome of the study was child stunting that was defined as a height-for-age Z (HAZ) score

Among the 601 mothers assessed, generalised anxiety disorder had the highest prevalence (36.6%), followed by recurrent major depressive disorder (27.3%), current major depressive disorder (22.7%) and current suicide risk (18.2%). Among the children, 27.1% were stunted, with prevalence rising from 9.8% in infants (1–12 months) to 39.9% in toddlers (25–36 months). Current major depressive disorders in mothers were associated with child stunting (adjusted OR 1.67; 95% CI 1.06 to 2.61). Affected children had lower HAZ scores (–1.68±1.36 vs –1.30±1.09; p=0.004), and excess relative risk (ERR) analysis confirmed depression as a significant risk factor (ERR: 1.56; p=0.005).

Mental health disorders in mothers, especially depression, showed a significant association with child stunting. Addressing mental health disorders in mothers is essential for improving child nutritional outcomes.

The use of digitally enabled technology is considered a promising platform to prevent morbidity and enhance youth mental health as youth are growing up in the digital world and accessing the Internet at increasingly younger age. This scoping review will identify, describe and categorise the models, frameworks and strategies that have been used to study the implementation of digital mental health interventions targeted at youth aged 15–34 years.

We will conduct a scoping review following the Arksey-O’Malley five-stage scoping review method and the Scoping Review Methods Manual by the Joanna Briggs Institute. Implementation methods will be operationalised according to pre-established aims: (1) process models that describe or guide the implementation process; (2) evaluation frameworks evaluating or measuring the success of implementation; and (3) implementation strategies used in isolation or combination in implementation research and practice. Primary research studies in all languages will be identified in CINAHL, Cochrane Central Register of Controlled Trials, Embase, ERIC, Education Research Complete, MEDLINE and APA PsycINFO on 6 January 2025. Two reviewers will calibrate screening criteria and the data charting form and will independently screen records and abstract data. We will use the Evidence Standards Framework for Digital Health Technologies by the National Institute for Health and Care Excellence to classify digital interventions based on functions, and a pre-established working taxonomy to synthesise conceptually distinct implementation outcomes. Convergent integrated data synthesis will be performed.

Ethical approval is not applicable as this scoping review will be conducted only on data presented in the published literature. Findings will be published and directly infused into our multidisciplinary team of academic researchers, youth partners, health professionals and knowledge users (healthcare and non-governmental organisation decision makers) to co-design and pilot test a digital psychoeducational health intervention to engage, educate and empower youth to be informed stewards of their mental health.

To develop and validate educational clinical vignettes (CVs) based on real-life patients with serious pathology from the disciplines of oncology, internal medicine and orthopaedics that are relevant for physiotherapists (PTs) working in a non-direct access system.

A mixed-methods study using an iterative design was employed to develop and validate CVs that focused on serious pathology.

Academic and clinical settings within health faculties at three universities in Austria and the UK.

Medical doctors (MD) (n=3) and PTs (n=4) developed CVs in the disciplines of internal medicine, oncology and orthopaedics. Validation of the CVs was undertaken in three stages: internal validation by the research team (n=7), external validation by MDs (n=3) and external validation by PTs (n=18).

25 CVs focusing on internal medicine (9), oncology (8) and orthopaedics (8) were developed. Results of the consensus method of Haute Autorité de Santé ranged between 7 and 9 in the internal validation stage. In the external validation stage with MDs, one orthopaedic CV was excluded, resulting in a final total of 24 validated CVs.

This is the first time educational CVs have been developed and validated across such a broad range of pathologies for countries without direct access to physiotherapy, for use in the education of PTs. Furthermore, the approach described in the Methods section of this paper may serve as a template in similar future projects.

Dysmenorrhoea (period pain) is a global public health issue affecting up to 91% of the 1.8 billion individuals who menstruate. While research has emphasised the improvement of menstrual health in low-middle-income countries, undertreated dysmenorrhoea remains an issue in high-income countries (HICs), where individuals often assume their pain experiences are normal. Studies report that individuals with dysmenorrhoea delay seeking medical care, avoid it entirely or are subjected to diagnostic and treatment delays. Difficulties accessing care are troubling, as individuals may suffer without access to evidence-based techniques, as well as the potential for underlying pathologies (eg, endometriosis, pelvic inflammatory disease) to go undiagnosed.

Many HICs have launched strategies for women’s health to address gaps in care access and knowledge around menstruation. Guided by Levesque and colleagues' (2013) Conceptual Framework of Access to Healthcare, this review will contribute to these strategies by providing an overview of factors affecting healthcare access for dysmenorrhoea in HICs from the point of perceiving a healthcare need to engaging with care, as well as factors affecting perceived quality of care.

This scoping review will follow the Joanna Briggs Institute’s (JBI) guidance for scoping reviews and will be conducted with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist extension for Scoping Reviews. Guided by Levesque and colleagues’ (2013) Conceptual Framework of Access to Healthcare, searching will seek to locate both peer-reviewed studies across PubMed, CINAHL, PsycINFO and Web of Science databases, as well as using web scraping to locate relevant grey literature. Results will be synthesised and mapped to construct a pathway to care, highlighting factors affecting the healthcare access for dysmenorrhoea, as well as factors related to the quality of healthcare interactions.

This review does not require ethical approval, as only existing data will be analysed. Results will be shared using peer-reviewed publications and conference presentations. Datasets emerging from the study will be made available on Open Science Framework.

This review was initially registered on Open Science Framework (https://osf.io/2dsrc/) in February 2024, with an updated protocol registered in February 2025.

Intrusive nightmares are a hallmark symptom of post-traumatic stress disorder (PTSD), contributing significantly to psychiatric comorbidities, impaired physical health and diminished social functioning. Currently, no pharmacological treatments are specifically approved for managing PTSD-related nightmares. However, emerging evidence suggests that adrenoceptor-targeting agents may offer therapeutic potential. Notably, clonidine and doxazosin have demonstrated efficacy in reducing PTSD-associated nightmares, as indicated by findings from open-label studies and small randomised controlled trials.

This study is a multicentre, double-blind, randomised (1:1:1), placebo-controlled, parallel-group interventional trial. A total of 189 eligible patients will be randomly assigned to receive clonidine, doxazosin or placebo, with a once-daily oral dose administered at bedtime for 10 weeks. The primary efficacy endpoint is the Clinician-Administered PTSD Scale B2 score at week 10, which measures the frequency and intensity of nightmares. Secondary efficacy endpoints include other PTSD-specific symptoms. Additionally, the safety of clonidine and doxazosin will be assessed.

The study was approved by the Ethics Committee of the State of Berlin (Ethik-Kommission des Landes Berlin) (Reference: 21-683-Haupt-IV E 13), on 14 March 2022 and by the relevant federal authority, the Bundesinstitut für Arzneimittel und Medizinprodukte, reference 4044931. The study was conducted in accordance with the relevant guidelines and regulations. The study results will be published in peer-reviewed journals and presented at both national and international conferences.

NCT05360953, EudraCT 2021-000319-21.

School environments that encourage children to be physically active can embed lifelong positive health behaviours and contribute towards reducing health inequalities. The Health and Activity of Pupils in the Primary Years (HAPPY) study aims to: (1) explore the extent to which the WHO criteria for creating active school environments are implemented by primary schools and (2) examine associations between active school environments and children’s physical activity, mental health and educational performance.

The HAPPY study is a quasi-experimental study comprising: (1) a survey of state-funded Greater London primary schools to identify implementation of the WHO’s six criteria and (2) a cross-sectional study to examine associations between schools’ active environment score (derived from the school survey) and pupils’ physical activity, mental health and educational performance. For our cross-sectional study, we will recruit up to 1000 year-three children (aged 7–8 years). Our primary outcome is accelerometer (GENEActiv) assessed physical activity, our secondary outcomes are parent-reported child mental health (Strengths and Difficulties Questionnaire) and teacher-reported educational performance (age-related expectations). Using multilevel mixed-effects regression models, we will examine associations between the active environment score and physical activity. Physical activity will be included as a measure of acceleration and also different intensities (light, moderate, vigorous). We will repeat this analysis to examine associations between the active environment score and mental health and educational performance. We will adjust for school characteristics and area-level deprivation and include pupil characteristics (eg, sex, ethnic group) as covariates. Clustering at the school level will be included as a random effect.

Ethical approval has been obtained from Imperial College Research Ethics Committee (ref: 6800895). Findings will be disseminated through a summary report to all participating schools, peer-reviewed publications, presentations at national and international conferences and National Institute for Health and Care Research policy briefings.

Cancer and its treatment can negatively impact physical function, general well-being and quality of life. An evidence-based strategy to manage this is to prescribe exercise. One approach is to prescribe exercise prehabilitation to improve pretreatment health and function. However, current exercise prehabilitation programmes are under-researched, and the quality of their reporting has not been systematically assessed.

This review aimed to identify the following: the characteristics of prehabilitation exercise programmes; how intensity, physical function, patient-reported outcomes and treatment-related outcomes were measured; the quality of reporting and programme implementation.

Studies were eligible for inclusion if they reported a cancer prehabilitation exercise intervention, reported outcomes relating to physical function and patient-reported outcomes, and full-text copies were available in English.

PubMed, Mednar and Scopus were screened for studies from inception until 4 of April 2024.

Exercise characteristics were extracted and manually charted in Microsoft Excel using the Template for Intervention Description and Replication. The tool for the assessment of study quality and reporting in exercise (TESTEX) framework was used to assess study quality and intervention reporting.

1495 results were retrieved, 28 of which were included. Exercise sessions lasted a mean of 42.5±21.9 min and were completed 3.7±1.3 times per week. 22 studies implemented concurrent exercise, five prescribed aerobic, and one prescribed resistance. High-intensity exercise was prescribed in four studies, moderate-high in 12, seven prescribed moderate, three prescribed low-moderate, and one was low intensity. 10 studies prescribed exercise intensity using the Borg Rating of Perceived Exertion Scale, five prescribed heart rate (HR) zones, six used a set workload, and seven did not monitor intensity. A mean TESTEX score of 9.3±2.3 out of 15 was achieved. The lowest scoring criterion (n=3) related to the reporting of the exercise dose.

There was heterogeneity among studies regarding exercise intervention characteristics and measures of effectiveness. The overall quality of reporting was satisfactory, yet inconsistencies were apparent regarding quantifying and monitoring exercise dose, which limits the ability of researchers and clinicians to replicate, evaluate or scale cancer prehabilitation exercise interventions, impeding evidence-based practice. As such, to be able to optimise cancer prehabilitation exercise programmes, research must first focus on improving the quality of reporting and standardising outcome measures and methods of monitoring and prescribing exercise.

Despite an increasing amount of research related to gender-affirming treatment (GAT) outcomes among transgender and gender-diverse (TGD) people (ie, people who experience discomfort or distress in the misalignment between their gender and sex assigned at birth) in recent years, the evidence base for current recommendations is suboptimal. One contributing factor is the heterogeneity in the outcomes and outcome measures used. This study seeks to address this challenge by developing a foundational core outcome set (COS) to be used for TGD adults receiving GAT in Sweden.

Recommendations from the Core Outcome Measures in Effectiveness Trials initiative will be used to address this aim in four phases. Phase 1, an umbrella review of peer-reviewed literature and international guidelines in GAT will be conducted to identify relevant outcomes. In phase 2, we will solicit input from TGD individuals through the review of patient and interest organisations’ reports and an anonymous survey to identify outcomes of personal significance. In phase 3, using the Delphi method, 2–3 rounds of assessment will be conducted where researchers, healthcare professionals, policy-makers and TGD adults rate the identified outcomes by perceived importance. In phase 4, a consensus meeting will convene representatives from all stakeholder groups to finalise the COS.

The results of this study will consist of a COS for GAT regarding TGD adults in Sweden. Participant survey responses will be evaluated using interpretive analysis to identify core outcomes. During each of the Delphi rounds, Likert-type scale ratings will be aggregated for outcomes to advance or be eliminated in each round.

The study has received ethical approval by the Swedish Ethical Review Authority (Umeå medicine department, Registration number: 2024-04672-01). The results of this study will be published open-access and disseminated through TGD interest organisations and a Swedish research network for gender dysphoria.

COMET registration number 3223.