In individuals at-risk of rheumatoid arthritis (RA), to investigate how joint tenderness and patient-reported joint pain (PRJP) relate to ultrasound abnormalities and assess whether these exploratory results could be used to assist future evaluation of symptom/signs-guided ultrasound scanning approaches in this population.

This is a cross-sectional analysis from a Leeds (UK) cohort of anti-cyclic citrullinated peptide (anti-CCP) positive individuals with new musculoskeletal complaints and no clinical arthritis. Assessments included physical examination, a mannequin where participants ticked joints that were painful and ultrasound scans of wrists, metacarpo-phalangeal joints 1–5 (MCPs1-5), proximal interphalangeal joints 1–5 (PIPs1-5), elbows, knees, ankles, metatarso-phalangeal joints 1–5 (MTPs1-5), finger flexor tendons (2-5) and extensor carpi ulnaris. Grey scale (GS), power Doppler (PD), tenosynovitis and erosions were assessed. A generalised estimating equations model was used to evaluate potential associations between tenderness/PRJP and ultrasound findings at the joint-level, adjusting for age and sex. Positive and negative predictive values for ultrasound changes were calculated.

323 participants were analysed. Joint tenderness was associated with ultrasound abnormalities, predominantly PD in wrists, MCPs, PIPs, elbows, knees and MTPs. GS and erosions were also associated with tenderness, but to a lesser degree. Association of PRJP with ultrasound abnormalities was more inconsistent and mostly for GS in the feet (all p≤0.05). Absence of symptoms and signs had a negative predictive value between 97% and 100% in all joints, except in wrists; which was slightly lower.

In anti-CCP positive individuals at risk of RA, tenderness, predominantly in the small joints, was associated with local inflammatory changes on ultrasound. The association of PRJP and ultrasound was limited. In the absence of tenderness, the presence of PD, tenosynovitis or erosions was uncommon. These findings may inform future studies evaluating symptom/sign-guided ultrasound assessment approaches in at-risk populations.

NCT02012764.

To examine the prevalence and sociodemographic factors associated with tobacco smoking, smokeless tobacco and dual use among adults in Ghana using the 2022 Demographic and Health Survey (GDHS).

Ghana, nationwide sample of males and females aged ≥15 years.

This was a cross-sectional secondary analysis of the 2022 GDHS.

A representative sample of 22 058 individuals (females, 15 014 aged 15–49; males, 7044 aged 15–59)

Current tobacco smoking, smokeless tobacco use and dual use.

Prevalence for smoking, smokeless tobacco and dual use was 4.7 (4.1–5.4), 1.6 (1.3–2.0) and 0.6 (0.4–0.9) among males and 1.0 (0.8–1.3), 0.08 (0.05–0.1) and 0.1 (0.05–0.1) among females, respectively. Among males, smoking was associated with higher age (30–44 years: AOR: 2.3, 95% CI 1.7 to 3.1; 45–59 years: AOR: 2.6, 95% CI 1.8 to 3.7). Higher education was protective for both sexes [(males: AOR: 0.4, 95% CI 0.2 to 0.8) and (females: AOR: 0.4, 95% CI 0.2 to 0.8)] compared with their counterparts who had no education. Males in the Coastal zone had higher odds of use (AOR: 1.8, 95% CI 1.3 to 2.3) compared with males in the Middle zone, while females in the Northern/Savanna zone had lower odds of tobacco use (AOR: 0.5, 95% CI 0.3 to 0.8) compared with the Middle zone. Being Christian was associated with lower odds of smoking among males (AOR: 0.3, 95% CI 0.2 to 0.5) compared with others, while being Mole-Dagbani ethnic is associated with higher odds of smoking among females (AOR: 3.0, 95% CI 1.7 to 5.4).

The study provides the first national analysis across Ghana’s 16 regions and investigates patterns of smoking, smokeless tobacco and dual tobacco use. While tobacco use in Ghana remains predominantly smoked and male-driven, the divergent patterns of use across educational, regional and ethnic groups, especially the emerging risk among females, represent a significant public health shift that demands focused gender-sensitive tobacco control interventions.

To develop a simple screening scale to predict depression after discharge in patients with acute coronary syndrome after percutaneous coronary intervention (ACS-PCI) and to verify its reliability, validity and cutoff value.

Prospective longitudinal study was conducted 1 week and 3 months after discharge.

Two hospitals where PCI is performed in Japan.

A total of 183 patients were potential candidates for the survey, of whom 42 provided valid responses (response rate: 23.0%).

The number of items was reduced from 14 to 12 with item-total correlations and principal component analysis. Cronbach’s alpha coefficient was 0.832 and the intraclass correlation coefficient (1, 2) was 0.811 (95% CI 0.650 to 0.898). Significant correlations were observed for concurrent validity (r=0.699, p

This study developed a simple screening scale for predicting postdischarge depression in patients with ACS-PCI (SDACS-12) and demonstrated its reliability, validity and predictive ability with 12 items. Nevertheless, its results should be interpreted cautiously given the moderate variance explained by PCA and the low specificity and PPV.

The important role of responsible media reporting as a low-cost, effective population-level suicide prevention strategy is well documented. However, research into its potential to generate protective effects and how this is perceived by audiences is underexplored in the Indian context. This qualitative study aimed to explore young adults’ experiences of exposure to current suicide-related and purpose-designed content in the media.

This qualitative study was nested within a larger randomised controlled trial. A semi-structured interview guide was designed to explore participant perspectives and experiences regarding exposure to media content.

The study was conducted with media professionals in Nepal.

A purposive sample of 20 young adults (10 males, 10 females) participated in the study. Interviews were audio-recorded and transcribed, and an inductive-deductive approach to thematic analysis was followed.

Participants shared a range of contrasting experiences related to suicide content in the media and their responses to purpose-designed media content. They reported typical characteristics of current media reporting of suicides involving sensationalism, exaggeration and simplistic assumptions and underscored its impact on mental health. The purpose-designed content elicited a sense of surprise among participants. It stimulated curiosity, improved understanding, challenged misconceptions and instilled hope. In contrast to existing media coverage, they viewed protective content as a valuable means of educating people about recovery and encouraging help-seeking.

This study uncovers unique insights into how young adults in the Indian context perceive and experience suicide reporting in the media. Our audience research indicates that current reporting styles may have harmful effects, while a more hopeful, recovery-oriented approach could offer significant benefits. These insights can be used to support meaningful collaborations between stakeholders in our efforts to encourage safe and respectful reporting that meets audiences’ needs to be kept informed.

CTRI/2022/09/045439.

Falls among community-dwelling older adults are prevalent and have serious individual, societal and economic consequences. Allied health professionals provide key falls prevention interventions yet their representation in current clinical practice guidelines is inconsistent. Increased recognition of allied health roles and delivering context-specific guidelines for falls care could help to address workforce gaps and optimise care approaches. This scoping review explored the roles of the allied health professions in falls prevention screening, assessment and intervention for community-dwelling older adults.

Scoping review, using the Joanna Briggs Institute methodology for scoping reviews.

PubMed, CINAHL, Scopus, Cochrane, Web of Science and Allied and Complementary Medicine Database databases. The initial search was completed in November 2023, with a secondary search performed in July 2025.

Sources were eligible if they identified or described a specific role of at least one allied health professional in falls prevention care for older adults. No restrictions were placed on publication type or date. Study protocols and conference abstracts were excluded, and only English-language sources were included.

ChatGPT-4o was used for initial data extraction. Authors then cross-checked and updated inaccuracies as required. A numerical descriptive analysis, and a qualitative content analysis were performed to answer the research questions.

The search identified 442 relevant sources from 34 countries. The roles of 17 allied health professions in falls prevention for community-dwelling older adults were discussed. Screening, assessment and intervention roles were identified spanning medical, physical capacity, environmental, education and behavioural–psychological domains. Profession-specific interventions closely aligned with their primary scope of practice, and notable areas of overlap between professions were highlighted.

This review highlights the diverse and overlapping contributions of allied health professionals to falls prevention in community-dwelling older adults. Varying levels of evidence are available across the professions and evidence gaps were highlighted for smaller allied health professions, indicating a need for foundational research to substantiate their roles and facilitate their inclusion in future practice guidelines.

https://doi.org/10.17605/OSF.IO/7SV3F.

Same-sex marriage legalisation improves mental health among sexual and gender minority (SGM) people. In Japan, where same-sex marriage is not legalised, some municipalities have introduced ‘partnership certificate’ schemes (PCSs) to offer same-sex couples social recognition without legal recognition. We examined whether mental health status in SGM adults differed between municipalities with and without PCSs.

We used cross-sectional data on adults aged ≥18 years from a nationwide internet survey conducted in September and October 2022. We estimated the relative difference by comparing the differences in mental distress and suicidal thoughts reported by SGM adults residing in municipalities with and without PCSs to the corresponding differences among cisgender heterosexual adults.

Mental distress (Kessler 6 Scale score ≥5) and self-reported suicidal thoughts, adjusted for sociodemographic characteristics, health status and municipal characteristics.

We analysed 28 106 participants (mean (SD) age, 48.2 (17.3) years), including 3169 (11.3%) SGM individuals. Despite no significant difference in mental distress, we found a statistically significant difference in rates of self-reported suicidal thoughts between municipalities with and without the scheme for the SGM group (average marginal effects (AME), +5.1 percentage points (pp); 95% CI +0.4 to +9.8 pp) and the cisgender heterosexual group (AME, –1.6 pp; 95% CI –3.0 to –0.1 pp; relative difference, +6.7 pp; 95% CI +1.8 to +11.5 pp).

Residing in a municipality with PCSs was not associated with better mental health among SGM people in Japan. This may reflect limited scheme uptake or perceptions of inequality with legal marriage. These schemes without national legislation may not adequately address internalised stigma or promote acceptance, and they may have lowered the self-esteem of SGM people, leading to worse mental health. Further research is needed to clarify the underlying mechanisms of this association.

The Comprehensive High-dose Aphasia Treatment (CHAT) programme is an intensive comprehensive aphasia programme, which aims to address evidence-practice gaps in aphasia rehabilitation where there are known barriers to service delivery requiring implementation strategies. The aims of this study are to (1) evaluate the clinical implementation of the CHAT programme, (2) assess the clinical effectiveness of CHAT compared with usual care in rehabilitation services and (3) determine whether the real-world implementation of CHAT compared with usual care is cost-effective.

Four participant groups will be recruited across six hospital and health services Australia-wide to participate in a type 3 hybrid effectiveness-implementation study: (1) people with aphasia, (2) support persons, (3) treating clinicians and students and (4) clinical stakeholders (eg, managers). This before-and-after study will include three time periods: (1) ‘usual care’ where people with aphasia will receive their usual care aphasia therapy, (2) ‘implementation transition’ where clinicians will be trained to deliver CHAT and (3) ‘intervention implementation’ where people with aphasia will receive the CHAT programme (ie, 50 hours of evidence-based aphasia therapy over 8 weeks). Evidence-based implementation strategies will be used to facilitate implementation within participating rehabilitation services. The primary outcome is delivery of evidence-based aphasia treatment (ie, CHAT) as measured by a composite score of quality indicators. Clinical effectiveness outcomes, measuring change in language impairment, communication effectiveness, confidence and quality of life, and implementation outcomes will also be examined. We will also conduct an embedded mixed-methods process evaluation and economic evaluation.

This study has been approved by the Royal Brisbane and Women’s Hospital Human Research Ethics Committee (HREC/2021/QRBW/72154). Outputs will include conference presentations, publications and a training package to optimise implementation of aphasia treatment in rehabilitation service contexts.

Australian New Zealand Clinical Trials Registry (ANZCTR) prospective registration ACTRN12621001765819. Trial registered 23 December 2021. https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=381365&isReview=true.

Rare skeletal disorders (RSDs) cause lifelong functional impairment, chronic pain and reduced quality of life. Evidence-based rehabilitation strategies remain underdeveloped, particularly for adolescents and young adults. We previously demonstrated preliminary feasibility of a 5-day adapted sailing intervention but observed benefit attenuation at 3-month follow-up. This pilot trial evaluates feasibility, acceptability and safety of intensive adapted sailing therapy followed by home-based telerehabilitation maintenance versus telerehabilitation alone.

This is a prospective, randomised, assessor-blinded, parallel two-arm pilot feasibility trial. 24 participants aged 12–30 years with confirmed RSDs will randomise with a 1:1 allocation ratio to: (1) 5-day adapted sailing therapy followed by 3-month telerehabilitation (n=12) or (2) 3-month telerehabilitation alone (n=12). Primary outcomes assess feasibility through recruitment efficiency (≥80% eligible patients enrolled), intervention adherence (≥75% sessions completed), participant retention (≥80% at 6-month follow-up), and safety (zero serious adverse events attributable to interventions). Secondary outcomes include sensor-based motor function (balance, gait, upper extremity mobility via inertial measurement units) and patient-reported outcomes (health-related quality of life, functional capacity, kinesiophobia, pain), measured at baseline, 3-month and 6-month follow-up. Exploratory analyses will estimate preliminary between-group effect sizes. Statistical analysis uses intention-to-treat principles with linear mixed-effects models.

The study received approval from the Area Vasta Emilia Centro Ethics Committee (363/2025/Sper/IOR) on 7 July 2025. The study is ongoing, and data collection is expected to be completed by March 2026. Results will be disseminated through peer-reviewed open-access publications, conference presentations, patient organisation partnerships and plain-language summaries.

NCT07102875.

Addition of bevacizumab and paclitaxel as induction therapy prior to standard atezolizumab and nab-paclitaxel in patients with programmed death-ligand 1 (PD-L1)-positive metastatic triple-negative breast cancer (mTNBC) may help to overcome vascular endothelial growth factor-associated resistance mechanisms that limit the immune-mediated antitumour efficacy of atezolizumab and nab-paclitaxel.

The Induction Therapy of PTX+BV Followed by Atezolizumab+Nab-PTX for PD-L1+TNBC (INDUCE) study is a multicentre, randomised, open-label, phase II trial designed to evaluate the efficacy and safety of two cycles of induction therapy with bevacizumab and paclitaxel followed by atezolizumab and nab-paclitaxel compared with standard atezolizumab and nab-paclitaxel in patients with PD-L1-positive mTNBC. The primary outcome of the study is progression-free survival (PFS) per Response Evaluation Criteria In Solid Tumours, V.1.1. We have estimated that 89 PFS events are needed to allow a power of 80% to detect a difference between treatment groups at a one-sided significance level of 10% in this study. The target sample size is set to 106 patients to account for dropouts.

The study protocol and informed consent form have been approved by the Certified Research Review Board at the Nagoya University Graduate School of Medicine, Nagoya, Japan. Study results will be presented at international conferences and published in a peer-reviewed journal.

jRCTs041240039 NCT06793553.

This study examines the prevalence of and risk factors associated with cognitive impairment among Indian stroke survivors aged ≥60 using data from the Longitudinal Ageing Study in India (LASI).

Cross-sectional comparative analysis.

Secondary analysis of Wave 1 (2017–2019) data from the nationally representative LASI.

A total of 844 individuals aged ≥60 years with a self-reported history of stroke and 2532 age-matched and gender-matched non-stroke controls selected at a 3:1 ratio from the LASI dataset.

The outcome measure was the prevalence of cognitive impairment among older adults with a history of stroke, assessed using a composite cognitive index (score ≤14) derived from five cognitive domains. We also aimed to identify socio-demographic, socioeconomic, behavioural and health-related factors associated with post-stroke cognitive impairment using multivariable logistic regression models.

Stroke survivors had a higher prevalence of cognitive impairment (15.3%) compared with non-stroke individuals (11.6%) and significantly lower cognitive function (composite score: 22.23 vs 23.78, p

Stroke survivors in India face increased risk of cognitive impairment, with associated risk factors including age, female gender, inactivity, depression and low body mass index, while higher education and expenditure status were associated with a reduced risk. Early detection and targeted interventions, including screening, lifestyle changes and personalised rehabilitation, are vital for preserving cognitive health after stroke.

Treatment for high-risk locally advanced prostate cancer typically includes radiation or radical prostatectomy plus androgen deprivation therapy (ADT), but the optimal use of neoadjuvant and adjuvant ADT in practice remains unclear. Relugolix and enzalutamide have demonstrated strong efficacy independently in the setting of advanced disease, but their combined use in neoadjuvant/adjuvant therapy has not been studied. This trial investigates their safety and efficacy as neoadjuvant/adjuvant therapy in patients undergoing definitive local treatment.

Relugolix and Enzalutamide as Neoadjuvant/Adjuvant to Local-regional treatment in Patients with High-risk, Locally Advanced Prostate Cancer (RENAPCA) is a prospective, single-arm, open-label phase Ib trial with blinded outcome assessment. The study is conducted across four tertiary oncology centres within the United States. Eligible participants are adult men with pathologically confirmed locally advanced high-risk prostate cancer who are candidates for definitive local therapy. Patients with significant comorbidities or a life expectancy of less than 6 months are excluded. The trial includes a 3+3 dose-escalation safety lead-in cohort (up to 12 patients) to determine dose-limiting toxicities and recommended phase 2 dose, followed by a dose expansion cohort (up to 46 patients). Interventions consist of 6 months of neoadjuvant therapy with relugolix plus enzalutamide, definitive local therapy (radical prostatectomy or radiation therapy), and 18 months of adjuvant therapy with relugolix plus enzalutamide. Primary outcomes include pathologic CR rate and minimal residual disease rate. Secondary outcomes include prostate-specific antigen response, progression-free survival, objective response rate, frequency and severity of adverse events, and positive margin/pathologic downgrade rate. Exploratory objectives include patient-reported outcomes and quality of life measures. RENAPCA will assess the safety and efficacy of neoadjuvant/adjuvant relugolix+enzalutamide in high-risk, locally advanced prostate cancer to support future larger-scale studies and potentially improve treatment outcomes.

This research protocol has been approved by the Institutional Review Board of the University of Oklahoma Health Sciences Center (7 March 2024). The study is based on voluntary participation with informed written consent.

NCT06130995.

Androgen deprivation therapy (ADT) improves survival in advanced prostate cancer but may lead to debilitating side effects, including sarcopenic obesity and a 10–45% increased risk of other comorbidities. Guidelines recommend exercise and nutrition interventions during ADT, but access to these services is often limited, and referral pathways are unclear. This study aims to evaluate the feasibility and preliminary efficacy of an online, home-based, multi-faceted, exercise, nutrition and education programme (ProHealth) for men with prostate cancer treated with ADT. ProHealth was co-designed with consumers and healthcare professionals to include (i) education on prostate cancer and treatment-related side effects and (ii) multimedia behaviour change resources to support individualised nutrition and exercise behaviour change.

This 12-week randomised controlled trial (target n=50) will include men treated with ADT for >3 months or who have completed ADT in the last 24 months, are overweight or obese and are not under the care of a dietitian or exercise professional. Participants will be randomised (1:1) to the ProHealth intervention or usual care. The intervention group will receive four consultations with an Accredited Practising Dietitian to promote a high protein and energy reduced diet, and five consultations with an Accredited Exercise Physiologist to follow a home-based progressive resistance training and aerobic exercise programme. The primary outcomes are feasibility (recruitment rate, retention, data completeness, reach, safety, consultation attendance and adherence, and usage of the ProHealth web platform), acceptability and satisfaction of the ProHealth intervention. Exploratory secondary outcomes will be assessed at baseline and 12 weeks and include changes in body weight and composition (total and appendicular fat-free mass, fat mass), quality of life (Functional Assessment of Cancer Therapy (FACT)—General, FACT-Prostate, FACT-Fatigue), physical function (30-second sit-to-stand), dietary intake (3-day food diary) and physical activity (7-day accelerometer). Linear regression models will estimate differences between the intervention and usual care group. Qualitative interviews on participant satisfaction will be transcribed verbatim for thematic analysis.

This study is approved by Deakin University Human Research Ethics Committee (DUHREC2024-038) and registered on Australian and New Zealand Clinical Trials Registry (ACTRN12624000874516). Findings will be disseminated through peer-reviewed journals, scientific meetings and other public forums.

ACTRN12624000874516.

Over 50% of patients participating in cardiac rehabilitation (CR) experience poor sleep and/or, closely related, psychological stress. Although stress management interventions are generally available, they are typically underutilised in CR, and sleep remains an underaddressed component within CR. This is concerning, as poor sleep and stress not only reinforce each other but are also associated with poorer cardiovascular health and lower quality of life. Therefore, the primary aim of the OPtimising CArdiac REhabilitation by REfining Sleep and STress (RESST) study is to investigate the (cost-)effectiveness of adding a behavioural intervention targeted at improving sleep and managing stress during CR (RESST intervention) on sleep and psychological stress. Furthermore, the study aims to explore the (bidirectional) associations between sleep, stress and lifestyle behaviours.

This parallel-arm multicentre randomised controlled trial will include 200 CR patients across 3 major CR centres in the Netherlands who experience poor sleep and/or stress. Patients will be randomised in a 1:1 ratio to standard CR or standard CR with the RESST intervention. Standard CR is a structured programme combining exercise, lifestyle guidance and risk management. On top of standard CR, the RESST intervention consists of 5 in-person group sessions targeting sleep and stress and is based on Acceptance and Commitment Therapy and Cognitive Behavioural Therapy. Primary outcomes are accelerometer-assessed and self-reported sleep and perceived stress. Secondary outcomes include quality of life, psychosocial well-being, chronic stress biomarkers (hair cortisol and cortisone), momentary fatigue, momentary stress and physical activity. Linear mixed models will be used to assess changes in outcomes at 3-month (after intervention and/or CR completed) and 6-month follow-up. The momentary data collected with ecological momentary assessment and accelerometry will be analysed using multilevel linear mixed models to explore the (bidirectional) relationship between sleep, stress and other lifestyle components such as physical activity.

This study was approved by the ethics committee of Erasmus MC, Erasmus University Medical Centre, Rotterdam, the Netherlands (MEC-2024-0238). The findings will be disseminated through publications in peer-reviewed journals, presentations at academic conferences and professional and patient publications.

NCT06505109.

Diabetic foot is an infection, ulceration or destruction of the tissue of the foot of a person diagnosed with diabetes mellitus (DM). Diabetic foot ulcer (DFU) is a major and preventable complication of DM. Adequate knowledge and foot self-care practices are crucial to reduce the risk of DFU complications, particularly in resource-limited healthcare settings.

To assess the knowledge and practices related to foot self-care and associated factors among individuals diagnosed with diabetes attending diabetic clinics at all base hospitals in Colombo District, Sri Lanka.

An analytical cross-sectional study was conducted among 423 individuals diagnosed with diabetes attending the diabetic clinic at all three base hospitals in Colombo district, from January 2023 to March 2024 (study period). Participants were selected by using a systematic random sampling. Data were collected using a validated and pre-tested interviewer-administered questionnaire. Descriptive and inferential analyses were performed using Statistical Packages for Social Sciences V.26 software. Associations were examined using ² tests, independent sample t-tests and one-way ANOVA (Analysis of Variance), with a p value

The majority of the participants were females (71.2%). Among the participants, 33.8% of them had a poor level of knowledge regarding foot self-care. Knowledge level was significantly associated with the participants’ family history of diabetes and the hospital where they attended the clinic (p

Nearly one-third of participants demonstrated poor knowledge of foot self-care, despite over half exhibiting satisfactory foot-care practices. This gap highlights the need for targeted education to boost awareness and promote consistent foot care, which is a key step in preventing diabetic foot complications and improving long-term outcomes for individuals diagnosed with diabetes.

Non-communicable diseases, particularly cardiovascular diseases (CVDs), have become major contributors to morbidity and mortality in sub-Saharan Africa (SSA) and are projected to surpass infectious diseases as the leading cause of death among adults by 2030. Although CVDs have traditionally been associated with older age and obesity, adverse cardiovascular phenotypes are increasingly being observed in younger and leaner individuals in SSA. This pattern suggests that pathways to CVD risk in SSA may differ from those described in high-income countries. Early-life infectious exposures, undernutrition and socio-demographic conditions common in many SSA settings have been proposed as potential risk factors. Still, empirical evidence linking these exposures to cardiovascular risk in early adulthood remains limited due to a scarcity of long-running birth cohorts in the region.

This protocol describes a new round of data collection nested within the Entebbe Mother and Baby Study (EMaBS), a population-based Ugandan birth cohort established originally as a clinical trial (ISRCTN32849447) between 2003 and 2006 with prospective follow-up from pregnancy through adolescence. All participants currently under follow-up will be invited to participate at approximately 21 years of age. Primary outcomes are physiological determinants of CVD measured in early adulthood, including blood pressure, blood lipid levels, body mass index, body composition and markers of glucose metabolism. Secondary outcomes include behavioural CVD risk factors (diet, physical inactivity, alcohol use and tobacco use) and qualitative measures of CVD knowledge and risk perception. Key exposures of interest include prospectively collected early-life and childhood infectious exposures (malaria and helminth infections), markers of growth and undernutrition, micronutrient status, inflammatory markers, socio-demographic factors and selected genetic variants. Quantitative analyses will use multivariable regression and causal modelling approaches and will be complemented by qualitative interviews and focus group discussions.

The study protocol has been reviewed and approved by the Uganda Virus Research Institute Research and Ethics Committee (UVRI REC Ref: GC/127/35), the Uganda National Council for Science and Technology (UNCST Ref: MV625), and the London School of Hygiene & Tropical Medicine Research Ethics Committee (LSHTM Ethics Ref: 8811). Written informed consent will be obtained from all participants before study activities. Study findings will be shared and discussed with participants and community stakeholders through established engagement platforms. Results will be disseminated to the scientific community through peer-reviewed publications and conference presentations, and data will be made available to other researchers via established data-sharing platforms. We will engage policymakers at the district, national and international levels to facilitate the translation of findings into policy-relevant outputs.

Patient decision aids (PtDAs) are effective interventions to support patient involvement in health decisions and have the potential to impact favourably on health inequities by reducing gender bias in clinical practice. The aim was to explore sex and gender reporting and differences in randomised controlled trials (RCTs) evaluating PtDAs for adults making treatment or screening decisions.

Secondary analysis of the Cochrane review of PtDAs of RCTs that reported sex and/or gender. The original review searched MEDLINE, Embase, PsychINFO and EBSCO from journal inception to March 2022. Two team members independently screened citations, extracted data and assessed risk of bias. For this secondary analysis, we only included primary outcomes from the original review. We assessed appropriate use of terminology for sex (biological attribute) and gender (social construct). When terms were used interchangeably, it was considered inaccurate. Findings were synthesised descriptively, and we used meta-analysis when two or more RCTs were conducted with females/women or males/men using similar outcome measures.

Informed values-choice congruence and the quality of the decision-making process (eg, knowledge, accurate risk perceptions, feeling informed, clear values, participation in decision making, undecided) and adverse events (eg, decision regret, emotional distress) by sex and gender.

Of 209 RCTs in the original review, 206 reported sex and/or gender, with 35 (17%) using accurate terminology. Of 206 RCTs, 70 were with females/women only, 27 males/men only, 12 analysed by sex/gender and 97 RCTs did not disaggregate findings by sex or gender. Meta-analysis comparing RCTs for females/women to usual care and RCTs for males/men only compared with usual care showed similar mean differences in knowledge scores (10.84 vs 9.38 out of 100; p=0.44). Males/men had significantly higher self-reported participation in decision making compared with females/women (RR 3.16 vs 0.95; p

In PtDA RCTs, sex and gender terms are used interchangeably and 6% analysed outcomes by sex or gender. Meta-analysis of males/men only given PtDAs showed higher self-reported decision making participation in clinical practice compared to usual care versus females/women only compared with usual care. Researchers must improve reporting sex and gender in PtDA RCTs to assess how it influences health inequities.