BMJ Open最新文献

Introduction: Upper aerodigestive tract (UADT) malignancies, involving oral cavity, pharynx, larynx and related anatomical regions, are associated with substantial morbidity and mortality worldwide. Early diagnosis remains challenging because conventional diagnostic approaches are often invasive, costly and frequently detect disease at advanced stages. MicroRNAs (miRNAs) involved in post-transcriptional gene regulation have recently emerged as promising minimally invasive biomarkers due to their remarkable stability in biological fluids and their dysregulated expression in cancer. Although literature showcases the diagnostic value of miRNA signatures for UADT malignancies, the reported diagnostic performance remains inconsistent. Therefore, a comprehensive synthesis of current evidence is essential to determine the overall diagnostic precision and clinical applicability of miRNA-based assays.

Methods and analysis: We will report the results of the systematic review as per Preferred Reporting Items for a Systematic Review and Meta-analysis of Diagnostic Test Accuracy Studies (PRISMA-DTA) reporting guidelines and adhere to the recommendations of the Cochrane Collaboration Handbook for Diagnostic Test Accuracy Reviews for conducting this review. The electronic databases of PubMed, Scopus, Web of Science and Embase will be systematically searched from inception onwards. Studies assessing the diagnostic performance of miRNA biomarkers in histopathologically confirmed UADT malignancies will be included. Two authors will independently perform study selection, data extraction and quality assessment (Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2)). Diagnostic accuracy meta-analysis will be conducted using a hierarchical bivariate random-effects model (Reitsma model) to jointly pool sensitivity and specificity estimates while accounting for heterogeneity and threshold effects. Hierarchical summary receiver operating characteristic curves will be constructed, and we will analyse pooled estimates of sensitivity, specificity, positive likelihood ratio, negative likelihood ratio and diagnostic OR at 95% CIs. Meta-regression followed by subgroup analysis will be undertaken to explore potential sources of heterogeneity, including specimen type, miRNA profiling method, study design and patient characteristics.

Ethics and dissemination: This study will synthesise data from previously published literature without involving individual patient data or direct participant involvement. Findings from this review will be dispersed via publication in a peer-reviewed journal and through presentations at National/International scientific platforms.

Prospero registration details: CRD420261384413.

Background: Older Chinese adults in the UK face unique needs when engaging in physical activity (PA), yet culturally appropriate strategies to promote PA remain limited.

Objective: To develop culturally appropriate PA promotion strategies for older Chinese adults living in the UK.

Methods: The intervention development comprised two stages: design and optimisation. It was informed by previous research findings and input from public and community involvement and engagement. Stage 1 combined the person-based approach (PBA), which involved developing guiding principles, an intervention planning table and a logic model, with seven steps of the Behaviour Change Wheel (BCW) to identify intervention functions, behaviour change techniques (BCTs) and delivery modes to enhance older Chinese adults' capability, opportunity and motivation for PA. Stage 2 used think-aloud interviews with 10 older Chinese adults to optimise the intervention.

Results: Six intervention functions (education, persuasion, incentivisation, training, modelling and enablement), 27 BCTs and multiple delivery modes were identified in stage 1. In stage 2, based on think-aloud interviews with 10 participants, three prototypes were retained in their original form, one new element was added and three were removed. The remaining components were retained with either minor or major modifications. The final strategies included culturally tailored PA booklets, monthly workshops and social media support groups.

Conclusions: By integrating evidence, theory and stakeholder perspectives, and by combining the PBA with the BCW, this study developed the first culturally appropriate PA promotion strategies for older Chinese adults in the UK. Further research is needed to evaluate their feasibility, acceptability and effectiveness.

Introduction: Hypertrophic cardiomyopathy (HCM) is a genetic cardiovascular disorder affecting approximately 1 in 200 to 1 in 500 adults, with nearly 70% exhibiting the obstructive phenotype Hypertrophic Obstructive Cardiomyopathy (HOCM). Randomised trials have demonstrated the efficacy of mavacamten, a first-in-class cardiac myosin inhibitor which significantly reduced outflow tract gradients and improved symptoms, exercise capacity and quality of life in the HOCM cases. Despite these findings, prospective real-world data on its safety and effectiveness remain limited, particularly in non-Western populations and further evidence from routine clinical practice is needed.

Methods and analysis: PERSIA-HOCM is a prospective, multicentre, observational study to be conducted at 19 cardiovascular referral centres in Iran. Adults aged 18 years or older with symptomatic obstructive HCM, defined as New York Heart Association (NYHA) class II to IV and a left ventricular outflow tract (LVOT) gradient of at least 50 mm Hg at rest or with provocation, who are prescribed mavacamten, will be enrolled. Key exclusions include left ventricular ejection fraction below 55%, non-obstructive phenotype and lack of consent. Participants will be followed for 1 year at 4-week intervals. Data collection will include symptoms, NYHA class, vital signs, echocardiographic parameters (including outflow gradients and ejection fraction), mavacamten dosing and adjustments and concomitant therapies. Echocardiography will be performed at weeks 4, 8, 12 and 24. Safety will be assessed using a predefined adverse event framework that includes mortality, hospitalisations and major clinical events. At weeks 12 and 48, cardiac troponin, N-terminal pro B-type natriuretic peptide and quality of life will be assessed. Primary endpoints will be safety, change in the NYHA class, resting and provoked LVOT gradient, quality of life, cardiac biomarkers and left ventricular ejection fraction. Secondary endpoints will include cardiac magnetic resonance imaging parameters for cardiac fibrosis, peak oxygen intake and genotype-based outcome. Analyses will be performed using R V.4.5.1, employing descriptive statistics, paired sample t tests and McNemar's test.

Ethics and dissemination: Ethical approval was obtained from the Research Ethics Committee of Rajaie Cardiovascular, Medical and Research Institute/Iran National Committee for Ethics in Biomedical Research (Code: IR.RHC.REC.1404.210). Written informed consent will be required and filled by the patients. Considering full data confidentiality, analysis reports will be public every 6 months. Findings will be disseminated through peer-reviewed publications and scientific conferences.

Objectives: Automated surveillance of endoscopy-related adverse events (AEs) from non-English free-text reports remains insufficiently evaluated. We compared rule-based and transformer-based natural language processing (NLP) for classifying index procedure reports according to 30-day clinician-adjudicated AE status.

Design: Retrospective, single-centre diagnostic accuracy study.

Setting: Tertiary endoscopy unit in Türkiye, August 2015 to August 2025.

Participants: The source cohort comprised 140 385 reports. All 1512 lexicon-positive and 2000 randomly sampled lexicon-negative reports underwent clinician adjudication, identifying 1208 AE-positive reports. A 13 333-report corpus was allocated at patient level to training (n=9333), validation (n=2000) and a locked, fully adjudicated test set (n=2000; 180 AE-positive).

Primary and secondary outcome measures: The primary outcome was confirmation of an attributable AE within 30 days. Models analysed the index report only, whereas adjudication included subsequent documentation. Secondary outcomes were AE category and documentation timing. Diagnostic accuracy measures included sensitivity, specificity, predictive values, F1 score and transformer precision-recall area under the curve (PR-AUC).

Results: The rule-based model achieved 84.4% sensitivity (95% CI 78.4% to 89.0%) and 99.5% specificity (95% CI 99.1% to 99.7%). The transformer achieved higher sensitivity (92.2%, 95% CI 87.4% to 95.3%; McNemar's test, p=0.01) and 98.4% specificity (95% CI 97.7% to 98.9%). Positive predictive values were 94.4% and 85.1%, and negative predictive values were 98.5% and 99.2%, for the rule-based and transformer models, respectively; both had F1 scores of 0.89. Transformer PR-AUC was 0.91 (95% CI 0.87 to 0.94). The transformer reduced false negatives from 28 to 14 but increased false positives from 9 to 29. Cohort-wide AE incidence was not estimated because lexicon-negative reports were only partially verified.

Conclusions: Both approaches had high specificity. The transformer reduced false-negative classifications but increased false-positive classifications. These findings support clinician-supervised retrospective case identification and quality assurance, but not autonomous diagnosis, prospective prediction or point-of-care use. External validation is required.

Introduction: The social determinants of health are the conditions in which people live and the systems around them that shape these conditions. Social determinants of health may affect diagnosis and treatment for people with multiple sclerosis (MS) even in countries with universal healthcare systems. This study will investigate whether a person's age, sex and/or gender, living in a more socioeconomically deprived area and being of a minoritised ethnicity impact access to a diagnosis of MS and disease-modifying treatments (DMTs) for people living in the catchments of specialist neurology centres with a total estimated catchment population of approximately 7 million people in England and Wales.

Methods and analysis: EQUITY-MS is a multicentre retrospective cohort study using routinely collected healthcare data. Study participants are people aged 16 and above who received a new diagnosis of MS between 1 January 2018 and 31 December 2024 while living within the catchment of five specialist neurology centres (located in Leeds, Bradford, Greater Manchester, Cardiff and East London). Data will be collected from patients' hospital records by clinical teams. The primary outcome is the length of time between MS diagnosis and prescription of any DMT. Secondary outcomes are prescriptions of a high-efficacy DMT and the duration between patient-reported symptom onset and MS diagnosis. We plan to adjust for clinical and demographic factors that could impact prescribing decisions.

Ethics and dissemination: The study was approved by the North West-Greater Manchester East Research Ethics Committee (National Health Service) (25/NW/0184) on 14 August 2025. Results will be published in peer-reviewed journals, and summaries will be provided to local MS societies and disseminated via the study website (https://bradfordresearch.nhs.uk/bradford-centre-for-health-data-science/equity-ms/).

Objectives: This study explored perspectives of practitioners providing weight management support for urban-dwelling young adults (18-35 years) with obesity in Sri Lanka, addressing an important evidence gap in understanding obesity management from a provider perspective.

Study design: This descriptive qualitative study employed face-to-face semi-structured interviews, and the data were analysed using a framework approach within thematic analysis.

Study setting and participants: Eight purposively selected practitioners involved in weight management in the Colombo District, Sri Lanka, were interviewed. Participants represented key domains of comprehensive obesity management, including dietary, physical activity, behaviour and medical management. Recruitment continued until thematic saturation was achieved.

Results: Two key themes emerged from the data: (1) Barriers to effective weight management and (2) Strategies to improve weight management. Within the first theme, five subthemes emerged, including limited knowledge and confidence among practitioners, provider attitudes towards clients, resource and service limitations, client motivation and adherence challenges and cultural and religious influences and myths. The second theme comprised four subthemes: early detection with a proper referral system, comprehensive and individualised care approach, continuous follow-up and self-monitoring and supportive social environment.

Conclusions: The findings indicate that obesity management is hindered by fragmented care, with provider, client and system-level factors constraining practitioners' weight management efforts and limiting opportunities for improved care. These findings suggest the potential value of strengthening interdisciplinary referral pathways and targeted training to support more coordinated care.

Introduction: The hepatitis C virus (HCV) is a significant healthcare burden across the globe and is a major cause of liver malignancies. However, patients with serious mental illness (SMI) living with HCV are disproportionately affected and underserved within the current care framework. A previous meta-analysis on this topic yielded a prevalence of 8%, which is considerably higher than that observed in the broader population. Since the original review was published in early 2022, an update is required to incorporate data published during and after the COVID-19 pandemic and to evaluate its effect on overall prevalence and care.

Methodology: This systematic review and meta-analysis will replicate the methodology of the original review. To ensure a thorough investigation, a systematic search strategy will be implemented across PubMed, Google Scholar, Scopus, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Embase and Web of Science to include studies published from 2 July 2020 to 22 June 2026. The review will include prospective observational and retrospective cross-sectional studies conducted among adults aged over 18 years with a verified SMI diagnosis and laboratory-confirmed HCV status. A dual-reviewer protocol will be employed to evaluate all retrieved titles, abstracts and full-text manuscripts to ensure unbiased selection. Any disagreements will be adjudicated by a third senior investigator. Methodological rigour will be assessed using the Joanna Briggs Institute (JBI) Critical Appraisal Checklist for Prevalence Studies Quality Assessment Tool for Systematic Reviews of Observational Studies. This validated instrument will ensure transparency and standardised quality assessment and will be supplemented by a customised 3-point global assessment. A Generalised Linear Mixed Model (GLMM) with a logit transformation will be used for the meta-analytical synthesis to effectively account for expected heterogeneity and extreme proportions, while the degree of inconsistency across studies will be quantified using the I² statistic.

Ethics and dissemination: Formal ethical clearance is not required for this study, as it relies entirely on the synthesis of secondary data from published articles.

Prospero registration number: CRD420261331799.

Introduction: Chronic pain is a public health priority that affects 18% of Dutch and 16% of German adults, representing a major societal burden. The Ems Dollart Region (EDR), which forms the northern part of the Dutch-German border area, is particularly characterised by lower incomes, more physically demanding jobs and lower health literacy, which are associated with higher pain prevalence. Individuals with lower socioeconomic status face greater pain-related disability and reduced quality of life. Public health campaigns underpinned by pain science education provide a strategy to improve understanding of pain among the wider public by addressing common misconceptions about its causes and management. However, large-scale population-level interventions and evaluations of such campaigns remain limited.

Methods and analysis: This protocol describes the design and implementation of a cross-border public health campaign in the EDR, aimed at improving public understanding of pain, changing attitudes and beliefs and promoting healthy behaviours. We will conduct a quasi-experimental before-after study in the EDR with a control group in Flanders (Belgium). The intervention is guided by behaviour change and biopsychosocial models. The campaign will deliver tailored content via social media, broadcast, print and online advertisements over a 24-month period. Two independent cross-sectional samples will be surveyed at baseline and at 2-year follow-up, comprising 3200 participants per measurement wave from three regions: the Netherlands and Germany as intervention regions, and Flanders, Belgium, as the control region. The primary outcome is the prespecified Pain Concepts Questionnaire ratio score, assessing pain-related knowledge, attitudes and beliefs. The primary analysis will use an adjusted difference-in-differences framework to estimate whether change in the primary outcome differs between the combined intervention regions and the control region. Secondary analyses will examine the Netherlands and Germany separately and will evaluate healthcare utilisation, medication use, health-related quality of life and work absenteeism.

Ethics and dissemination: This study protocol was reviewed by the Medical Ethics Review Board of the University Medical Center Groningen and the University of Oldenburg. The study was considered not subject to the Medical Research Involving Human Subjects Act (non-WMO declaration; reference number M24.345555, issued on 31 December 2024) and was approved by the University of Oldenburg Ethics Committee (reference number 2025-056, issued on 07 March 2025). Informed consent was obtained electronically by the research agency at the time of participants' registration with the research panel. Study findings, regardless of outcome, will be disseminated through peer-reviewed publications and presentations at national and international conferences.

Background: Endometriosis affects approximately one in seven women in Australia and is associated with substantial physical, psychological and social impacts. Informational support is critical for enabling informed decision-making and fostering women's agency in care. While healthcare providers play a central role in delivering such information, existing research has predominantly focused on General Practitioners, despite the pivotal role of gynaecologists in endometriosis management.

Objectives: This study aimed to explore Australian women's experiences of endometriosis informational support from gynaecologists.

Design/setting: A descriptive qualitative study was conducted using semi-structured online interviews.

Participants: 16 women over 18 years old living in Australia with suspected or confirmed endometriosis.

Results: Three main themes were generated: Finding a gynaecologist who felt right: navigating a complex care pathway; Variance in informational support before diagnostic surgery and the uncertainty of recovery time; and Understanding what comes next: informational support and its gaps after diagnosis. The women emphasised the importance of finding not just any gynaecologist, but one with specific expertise in endometriosis. Factors such as geographical location, health insurance and referral pathways shaped this process. Once laparoscopic surgery was scheduled, informational support became particularly important in preparing women for the procedure, with surgical techniques and recovery expectations identified as key areas of informational need. Following diagnosis, the women highlighted the importance of clear communication regarding the nature of endometriosis, available treatment options and fertility considerations.

Conclusion: Informational support was found to be essential across all stages of the diagnostic and post-diagnostic journey. However, the women identified ongoing gaps, suggesting that the provision of information by gynaecologists could be further strengthened to better meet women's needs.

Introduction: Tuberculous pericarditis is a severe, high-mortality manifestation of extrapulmonary tuberculosis. Its diagnosis is hindered by the invasive nature of specimen collection and the limited sensitivity of conventional microbiological tests. Third-generation sequencing (TGS) offers a promising, rapid and comprehensive molecular approach for detecting Mycobacterium tuberculosis, but its specific diagnostic accuracy for tuberculous pericarditis has not been systematically evaluated. This planned systematic review and meta-analysis aims to precisely determine the diagnostic performance of TGS for this condition.

Methods and analysis: A protocol has been prospectively registered with PROSPERO. We will comprehensively search multiple databases (PubMed, Embase, Web of Science, SCOPUS, Cochrane Library) from inception to July 2027. We will include diagnostic accuracy studies that evaluate TGS against a composite reference standard for tuberculous pericarditis. Where available, we will also separately analyse studies that use a definitive reference standard. Two independent reviewers will screen records, extract data and assess methodological quality using the QUADAS-2 tool. A bivariate random-effects model will be used to pool sensitivity and specificity, with results summarised using hierarchical summary receiver operating characteristic curves. Heterogeneity will be explored via subgroup analysis and meta-regression. The certainty of evidence will be graded using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework.

Ethics and dissemination: Given that this investigation exclusively draws on open-source, non-identifiable data, formal institutional ethics clearance is not required. On finalisation, the findings of this systematic review will be disseminated via a suitable peer-reviewed journal. In parallel, every research phase-spanning protocol design to the final report-will rigorously comply with the established methodological standards for systematic reviews and meta-analyses of diagnostic test accuracy.

Trial registration number: CRD420261429012.