BMJ Open最新文献

Introduction: Cystic fibrosis (CF) is a life-shortening genetic disorder traditionally mischaracterised as affecting only populations of European descent. This framing has contributed to under-recognition of CF in African populations, despite emerging evidence of both common and region-specific cystic fibrosis transmembrane conductance regulator mutations across the continent. Diagnostic barriers, structural inequities and lack of surveillance further exacerbate disparities in care and visibility.

Methods and analysis: This scoping review aims to characterise CF in African populations by synthesising evidence on clinical presentation, diagnostic practices, genotypic diversity, prevalence and structural barriers to care. We will include case reports, cohort studies, registry analyses and other primary data sources involving individuals of African descent with suspected or confirmed CF. Key outcomes include clinical phenotype, age at diagnosis, mutation profile, diagnostic testing access and mortality. Data sources include Ovid Medline, Embase, Ebsco Global Health, CAB Abstracts and Web of Science Core Collection. Multiple-reviewer screening and extraction will be conducted. We will use narrative synthesis, thematic analysis and meta-analysis for prevalence where feasible.

Ethics and dissemination: No ethical approval is required as the review uses published data. Results will be shared with clinicians, researchers and CF networks in Africa and globally to inform diagnostic strategies and policy.

Introduction: Most adolescents fail to achieve recommended levels of vigorous-intensity physical activity, despite the established benefits for cardiorespiratory fitness and vascular health. Supervised interventions can be effective, but are resource-intensive and lack scalability. Mobile health (mHealth) technologies may provide a cost-effective and accessible approach to support structured, individualised training for adolescents. The Motivating Adolescent Fitness (MOTAFIT) trial will assess the feasibility and acceptability of an mHealth-supported exercise intervention for adolescents to inform the design of a definitive randomised controlled trial (RCT).

Methods and analysis: MOTAFIT is a three-arm feasibility RCT targeting 120 adolescents aged 13-16 years from the Okanagan Valley, British Columbia. Participants will be randomised (1:1:1) to: (1) MOTAFIT, (2) active control or (3) control group. The 12-week intervention targets ≥40 min/week of vigorous-intensity exercise (≥80% HRmax), co-designed with an exercise specialist and supported by mHealth technology. Primary outcomes for feasibility, including recruitment, retention, adherence, fidelity and acceptability, will be assessed as part of a process evaluation. Secondary measures (cardiorespiratory fitness, vascular health and blood pressure) will provide preliminary estimates to guide future sample size calculations.

Ethics and dissemination: The study has received approval from the University of British Columbia Clinical Research Ethics Board (H22-03183) and the University of Victoria Human Research Ethics Board. Parental consent and adolescent assent will be obtained prior to participation. Findings will be disseminated via peer-reviewed publications, conferences and community engagement.

Trial registration number: NCT06409793.

Background: Rheumatoid arthritis (RA) and spondyloarthritis (SpA) are chronic inflammatory rheumatic diseases characterised by pain, fatigue, mood disturbances, sleep problems and reduced quality of life. These symptoms are highly variable both between individuals and within individuals across days, reflecting the fluctuating nature of disease activity and daily functioning. Although physical activity is known to alleviate many of these symptoms, individuals with RA and SpA often encounter barriers that limit regular engagement. Capturing the dynamic interplay between symptoms and physical activity therefore requires methods that account for day-to-day and moment-to-moment variability. Ecological momentary assessment (EMA), especially when combined with actigraphy, enables real-time, context-sensitive monitoring of symptoms and physical activity in daily life. However, little is known about the feasibility and acceptability of such protocols in individuals with RA and SpA, for whom participant burden and adherence may represent significant challenges. This pilot study therefore aims to assess the feasibility and acceptability of a 14-day EMA protocol and to explore factors associated with objectively measured physical activity in individuals with RA and SpA.

Methods and analysis: 50 adults diagnosed with RA or SpA will be recruited through rheumatology clinics or via advertisement. Eligible participants must be smartphone users without cognitive or physical impairments affecting participation. After providing consent, participants will complete baseline questionnaires regarding disease activity, quality of life, sleep, pain, fatigue, affective states and will attend a remote session with a member of the research team to learn how to use the mobile app. They will then complete a 14-day EMA protocol, during which data on patient-related outcomes (PROs), including pain, fatigue, sleep quality and affective states (i.e. positive and negative affects) will be assessed four times daily: upon awakening, 11:00, 15:00 and 20:30. Physical activity and sleep will be continuously monitored using both a wrist-worn and a thigh-worn device. Feasibility will be evaluated based on adherence to EMA prompts and actigraphy wear time. Acceptability will be assessed via a study-specific questionnaire and qualitative interviews conducted at the end of the protocol. Exploratory analyses will examine real-time, temporal and lagged relationships between PROs (pain, fatigue affective states), sleep and physical activity levels.

Ethics and dissemination: This study was approved by the French national ethics committee [Comité de protection des personnes Nord Ouest I, 2025-A01349-40] on 24/07/2025. The results will be disseminated in peer-reviewed journals and at international conferences.

Trial registration number: NCT07167784.

Introduction: Peripheral artery disease (PAD) affected approximately 800 000 Canadians aged 25 years or older in 2015 and it poses a substantial risk of lower extremity amputation (LEA). While clinical risk factors for amputation are well-established, the impact of social determinants of health (SDoH) on amputation risk remains unclear, particularly in a Canadian context.

Objectives: This systematic review aims to: (1) synthesise evidence on the associations between multilevel SDoH domains and LEA (both major and/or minor) risk in Canadian PAD patients including intersectional effects of race and ethnicity with another SDoH domain, and (2) evaluate the statistical methodologies used in the researched literature to inform future study design and analysis approaches.

Methods and analysis: We will systematically search MEDLINE, Embase, EmCare, Global Health, Cumulative Index to Nursing and Allied Health Literature and Web of Science for studies examining SDoH and LEA in Canadian patients with PAD (including chronic limb-threatening ischaemia which is a severe form of PAD). Date limits for each database will be from inception through December 2025. SDoH will be categorised using a modified Healthy People 2030 SDoH framework under six domains: economic stability, education, food, neighbourhood and physical environment, healthcare system and community and social context. Two reviewers will independently screen titles, abstracts and full texts, with discrepancies resolved by a third reviewer. Data will be extracted on study characteristics, SDoH measures, outcomes and statistical methods. Risk of bias will be assessed using RoB 2 for randomised trials, ROBINS-I for non-randomised studies of interventions and ROBINS-E for studies investigating exposures. A narrative synthesis, and where data permit, a Bayesian hierarchical meta-analysis using both effect size and contingency table approaches will be conducted. Statistical heterogeneity will be explored through subgroup analyses and meta-regression, examining study design, SDoH measurement approaches and population characteristics.

Ethics and dissemination: As a systematic review and meta-analysis, ethics approval is not required. For institutional oversight, we provide the contact of Dr Sonia Anand (Associate Vice-President, Global Health, McMaster University; anands@mcmaster.ca). Results will be reported following PRISMA guidelines and disseminated through a peer-reviewed publication.

Prospero registration number: CRD420251115759.

Objectives: Patient self-testing (PST) for warfarin management is well-established in developed countries but remains underused in developing regions. This study compared the safety and effectiveness of PST with usual care (UC) in China.

Design: A multicentre, open-label, randomised, controlled trial.

Setting: A total of five centres participated in this study, including one provincial tertiary hospital, two municipal tertiary hospitals and two primary hospitals.

Participants: Patients undergoing mechanical heart valve (MHV) replacement at five centres were prospectively enrolled. Patients were trained and stratified according to time on warfarin at enrolment and were randomly assigned to the PST or UC group.

Interventions: The PST group used a point-of-care testing device for at-home international normalised ratio (INR) monitoring with pharmacist-guided warfarin dosing, while the UC group attended outpatient clinics for INR monitoring and dosing.

Primary and secondary outcome measures: The primary outcome was the difference in time in therapeutic range (TTR). The secondary outcomes were incidences of major bleeding, thromboembolism and all-cause deaths in 12 months.

Results: From March 2021 to March 2023, a total of 556 patients were enrolled, with a mean age of 47.5 years, 45.1% being male. 342 were newly initiating warfarin therapy, while 214 had been on warfarin for over 6 months. Baseline characteristics were similar between the PST and UC groups. The PST group showed significantly higher TTR (67.2% vs 55.1%, p<0.001) and lower incidences of major bleeding (0.7% vs 7.9%, p<0.001) and thromboembolism (0.4% vs 6.8%, p<0.001), with no difference in all-cause mortality (0.4% vs 1.8%, p=0.22). Logistic regression identified that using PST and younger age were independent factors associated with fewer warfarin-related adverse events.

Conclusions: A pharmacist-led PST intervention with ongoing education and counselling led to improved TTR and clinical outcomes in patients with MHV in China.

Trial registration number: China Clinical Trial Registry (ChiCTR2000038984).

Introduction: Research has increasingly underscored the impact of factors such as socioeconomic status, education, healthcare access, housing and environmental conditions in shaping population health outcomes. These factors, collectively called social determinants of health (SDOH), provide crucial context for understanding drivers of health outcomes. In sub-Saharan Africa (SSA), the study of SDOH is critical due to the region's unique sociocultural and economic conditions. Understanding how SDOH interacts with health systems and capturing SDOH in data is crucial for informing modelling efforts and policies improving population health more effectively. This scoping review aims to map the types of data used to capture SDOH in research conducted in SSA, to identify research gaps and to summarise key findings.

Methods: This scoping review will follow the Arksey and O'Malley methodological framework, enhanced by Levac et al, providing best practices for identifying, selecting and analysing eligible studies. Key steps include (1) identifying the research question, (2) identifying relevant studies, (3) selecting eligible studies via a locally curated search, (4) extracting information, (5) collating, summarising and reporting results and (6) consultation with stakeholders.

Ethics and dissemination: Ethical approval is not required, as this review relies solely on published literature. Findings will be disseminated across academic channels (journals, conferences) and through targeted stakeholder engagement efforts, such as policy briefs and public health workshops, to reach policymakers, healthcare practitioners and community health organisations. This dissemination strategy aims to inform health policy and drive programme development in SSA.

Objectives: To describe the incidence, presentation and long-term health outcomes of suicidal thoughts and behaviours (STBs) in children aged 12 years or under.

Methods: This population-based study included children identified through the Rochester Epidemiology Project who presented between 2005 and 2023 with STBs across primary, secondary and tertiary care centres in Olmsted County, Minnesota, USA. Information related to the patient and family characteristics, presentation, prior history and outcomes was manually extracted by two independent researchers. Patients were excluded if the index visit note could not be located, the patient had no suicidal ideation, attempts, intent or plan, was older than 12 years 11 months at the index date, less than 2 years old or was a duplicate entry.

Results: The average annual population was 28,035 children, of which 637 presented with STBs (mean (SD) age, 10.6 (1.7) years; 51.2% girls, 76.3% White, average follow-up 7 years). The majority of the cases presented to the emergency department (ED) 491 (77.1%). The annual incidence per 100,000 person-years tripled from 68.8 in 2005 to 208.6 in 2023. Overall, 105 patients (16.5%) presented with a suicidal attempt. There were no cases of death by suicide. A prior psychiatric diagnosis was present in 454 (71.3%). STB events were preceded by a precipitating event in 471 (73.9%), the most common of which was an argument with a parent, followed by a bullying event and family distress. A specific suicide plan was reported by 328 (51.5%) with laceration reported most frequently, followed by hanging and overdose. Significant predictors of a suicide attempt were previous use of mood stabilisers (OR 3.21; 95% CI 1.24 to 7.97) and having a specific plan (OR 2.73; 95% CI 1.72 to 4.41). Children who had suicidal attempts had more subsequent ED visits (3.50 vs 2.58; p=0.009) and hospitalisations for psychiatric reasons (1.90 vs 1.30; p=0.003) and psychiatric hospitalisation days (12.70 vs 9.04; p=0.048). Subsequent suicide attempts occurred in 31% of the cohort during follow-up.

Conclusion: STBs in preadolescent children are rare but are increasing in incidence. Such children have significant psychological diagnoses, use of mental health services, and subsequent suicide attempts. Novel age-appropriate interventions are needed.

Background: Despite several intensive interventions, HIV remains a major public health challenge affecting many individuals worldwide and highlighting ongoing gaps in HIV testing.

Objectives: To assess the proportion of 'never been tested for HIV' and the risk factors associated therewith among women aged 15-49 years.

Methods: The 2022 Tanzania Demographic and Health Survey data were used for this study. The variable of interest was whether women of reproductive age (WRA) reported never being tested for HIV. A total weighted sample of 15 254 WRA participated in the study. A survey logistic regression model was employed to determine factors associated with never being tested for HIV, as it accounts for the complexity of the sampling design. Analysis was performed at a 5% level of significance using R statistical software V. 4.5.2.

Results: Of the 15 254 WRA that participated, 3082 (20.2%) reported never being tested for HIV. The median (IQR) age of participants was 28 (21-37) years. The odds of never being tested for HIV decreased with increasing age (OR=0.96; 95% CI 0.95 to 0.97). Furthermore, factors such as having primary or secondary education, being pregnant or breastfeeding, marital status (married, living with a partner, widowed, divorced or separated), living in a female-headed household, using the internet, abstaining from sex, being aware of HIV test kits but never using them, media exposure, belonging to the middle wealth index category, using contraceptives and having other sexual partners besides a spouse within the past 12 months was found to be associated with never being tested for HIV among WRA in Tanzania.

Conclusion: This current study identified several factors associated with never being tested for HIV among WRA. To enhance HIV testing uptake in this population, government and public health stakeholders should design targeted interventions that address these determinants, particularly by improving access to education, promoting health awareness and integrating HIV testing into routine reproductive health services.