BMJ Open最新文献

Introduction: Transgender and gender-diverse individuals often face significant barriers to accessing gender-affirming care, such as hormones and/or surgery, leading to poorer mental health, lower quality of life, and higher rates of substance use and suicidal ideation. Vaginoplasty, the most commonly sought genital gender-affirming surgery (GGAS), is desired by over half of all trans women but has been performed in only a minority. This is due largely to limited surgeon availability and long wait times. Peer support has been shown to improve health outcomes and reduce stigma in marginalised populations, including trans communities, but has never been studied for efficacy during the perioperative period of GGAS. Building on priorities identified by multi-stakeholder engagement from the Transgender & Non-Binary Surgery Allied Research Collective, the Support for Transgender and Nonbinary Individuals Seeking Vaginoplasty (STRIVE) study aims to evaluate the efficacy of a centralised peer support and education intervention for patients seeking vaginoplasty, addressing a critical gap in perioperative care.

Methods and analysis: The STRIVE Study is a pragmatic, multi-site randomised controlled trial enrolling trans adults seeking full depth vaginoplasty. Participants are randomised to one of two arms; enhanced usual care, or a facilitated group intervention. The primary outcome is coping self-efficacy at 6 months, with a secondary outcome of surgical readiness. Primary analysis uses an intention-to-treat approach with linear mixed effects modelling, adjusting for selected baseline values and site. The feasibility evaluation data collected via qualitative interviews will be analysed thematically.

Ethics and dissemination: Approvals were granted by the primary site's Institutional Review Board on 10 May 2024 (STUDY00026957). The trial was registered on 24 May 2024. Results will be published in open access journals and made available to community members in plain language formats.

Trial registration number: NCT06436560.

Introduction: Community support for individuals with mental health problems is a global public health issue. Poor mental health literacy and high levels of stigmatising attitudes among the general population can hinder both help-seeking behaviours and limit the capacity of community members to provide support to people experiencing mental health challenges. The Mental Health First Aid (MHFA) training course was created to educate community members to provide initial help towards a person developing a mental health problem. MHFA training has spread to high-income countries, but there is relatively little research on cultural adaptation to lower-resource settings. This study aims to fill that gap and is the first cluster randomised controlled trial (cRCT) assessing the effectiveness of MHFA training in Chile and Argentina.

Methods and analysis: The study involves a two-arm wait-list cRCT with 240 participants (120 in each country). The study will be conducted in three settings in each of Chile and Argentina (eg, universities, health services and workplaces). Two clusters per setting in each country will be paired and randomly allocated to the intervention (the MHFA training for Chile and Argentina) or the wait-list control group. Participants in the intervention arm will be asked to complete questionnaires at baseline (T1), after training completion (T2) and 6 months after completion (T3), with control arm participants completing data collection at corresponding time points. The primary outcome will be intended support towards someone experiencing a mental health problem or experiencing a mental health crisis. Secondary outcome measures will include the ability to recognise depression and psychosis in vignettes; beliefs about the helpfulness of different types of interventions and helping actions, confidence in providing MHFA and stigmatising attitudes towards a person with depression or psychosis. Findings will demonstrate whether the culturally adapted MHFA training for Chile and Argentina can effectively enhance intended support, knowledge, attitudes and supportive actions towards other individuals within the community.

Ethics and dissemination: Ethics approval has been granted by the Human Research Ethics Committee at the University of Melbourne (Australia), Proyecto Suma (Argentina) and the University of Chile (Chile). Dissemination will be via academic publications and conference presentations. These will also be made available to participants and other interested parties on request.

Trial registration number: ISRCTN63724445.

Objective: The objective of this study was to examine patient experiences with virtual (telephone and video) encounters in primary care and make recommendations to inform the broader adoption of virtual care.

Design: A descriptive qualitative study using semi-structured interviews for data collection.

Setting: Ontario, Canada.

Participants: Fifty-five primary care patients across Ontario, Canada, who had experienced at least one virtual (telephone or video) encounter with a healthcare provider in primary care, participated in semi-structured individual interviews conducted between 15 January 2021 and 22 March 2021.

Results: With respect to patients' experiences with virtual care appointments, we identified the following seven themes: (1) Enhancing access, (2) Importance of patient-provider relationship, (3) Active communication and attunement, (4) Assuring privacy and confidentiality, (5) Shorter appointments, (6) Asynchronous technologies being underutilised and (7) Strengthening the future of virtual care. Despite the rapid adoption of synchronous virtual care, participants generally reported positive experiences. Virtual care enhanced access to care and was overwhelmingly supported for continued use. While new patient-provider relationships faced challenges, pre-existing, positive relationships thrived. Concerns about the shortness of virtual care appointments were reported.

Conclusions: Virtual care offers a promising modality for patients to experience care. Moving forward, primary care practices should consider expanding options for asynchronous virtual care, consider the length of virtual care appointments and offer patients greater choice in the modality of their care appointments.

Objectives: To investigate the incidence, prevalence and mortality of anorexia nervosa (AN) among individuals with childhood-onset type 1 diabetes (T1D) compared with matched controls in Sweden.

Design: Retrospective nationwide cohort study using linked registry data.

Setting: Nationwide, Sweden; population-based registers (covering the period 1977-2019).

Participants: 12 202 individuals diagnosed with T1D before age 15 years (5618 females; 6584 males) and 48 484 age-matched, sex-matched and municipality-matched controls without diabetes (23 618 females; 24 866 males).

Primary and secondary outcome measures: AN diagnoses (International Classification of Diseases-10 codes F50.0 and F50.1) identified via the National Patient Register. Outcomes were period prevalence, point prevalence at ages 15 and 20 years, 10-year incidence rates and proportional mortality ratios (PMR), stratified by sex. ORs and incidence rate ratios (IRR) with 95% CIs were estimated using Mantel-Haenszel methods; Kaplan-Meier analysis compared time to AN diagnosis between groups.

Results: The period prevalence of AN among females with T1D was 1.9% compared with 1.1% in controls (OR 1.64, 95% CI 1.31 to 2.06; p<0.001). The 10-year incidence rate for females with T1D was 74.7 per 100 000 person-years vs 45.2 per 100 000 person-years in controls (IRR 1.77, 95% CI 1.35 to 2.32). Point prevalence at age 15 years was 0.87% (T1D) vs 0.53% (controls) (IRR 1.65, 95% CI 1.16 to 2.35), and at age 20 years was 1.73% (T1D) vs 1.11% (controls) (IRR 1.55, 95% CI 1.20 to 1.99). The PMR for females with both T1D and AN compared with controls without either condition was 20.4 (95% CI 6.6 to 47.6). Male cases were few (n=4 in the T1D group; n=12 in controls).

Conclusions: Females with childhood-onset T1D in Sweden have an elevated risk of AN and markedly higher mortality when both conditions are present. Despite the increased relative risk, the absolute risk of AN in females with T1D remained below 2%. These findings support routine screening for eating disorders in the T1D population, particularly among adolescent and young adult females.

Introduction: Pulmonary embolism (PE) is a potentially fatal condition requiring timely diagnosis and treatment. CT pulmonary angiography (CTPA) is the gold standard for diagnosis and indicates PE severity through radiological markers of right heart strain. However, accurate interpretation and communication of these findings is often suboptimal in real-world practice. Artificial intelligence (AI) could alleviate pressure on radiology services by supporting PE identification, risk stratification and worklist prioritisation. Before widespread adoption, AI tools must be rigorously validated for diagnostic accuracy, safety and clinical impact.

Methods and analysis: This pragmatic single-centre, non-randomised quasi-experimental study will evaluate the diagnostic accuracy, feasibility, and clinical-cost impact of AI-assisted PE detection and risk stratification using AIDOC and IMBIO software. We will recruit two consecutive cohorts of adult patients undergoing CTPAs for suspected PE: a comparator cohort (12 months pre-AI implementation) and an intervention cohort (12 months post-AI implementation). AI will be applied retrospectively to the comparator cohort, while in the intervention cohort, radiologists will have contemporaneous access to the AI's interpretation of CTPA images.A subset of retrospective scans, both PE-positive and PE-negative, will undergo expert thoracic radiologist review to establish a reference standard. Data on patient demographics, clinical management and outcomes will be collected. Clinical management pathways and patient outcomes will be compared between cohorts to assess AI's influence on acute PE management. Health economic modelling will assess the cost-effectiveness of integrating AI technology within the diagnostic workflow of acute PE.

Ethics and dissemination: This study was approved by the UK Healthcare Research authority (IRAS 311735, 10 May 2023). Ethical approval was granted by West of Scotland Research Ethics Service (23/WS/0067, 3 May 2023). Results will be shared with stakeholders, presented at national and international conferences, and published in open-access peer-reviewed journals.

Trial registration number: NCT06093217.

Introduction: Healthcare logistics involves the coordination of resources, services and infrastructure to ensure timely and efficient care delivery. Process mining offers data-driven insights into logistical workflows such as patient transport, inventory management and scheduling. This systematic review aims to synthesise evidence on the application of process mining in healthcare logistics, focusing on its impact on operational efficiency, resource utilisation and service delivery.

Methods and analysis: A systematic search will be conducted in MEDLINE, Embase, Google Scholar, Web of Science and ABI/Inform for studies published from 1999 onward. Eligible studies will include observational studies, case reports, conference papers and meta-analyses focusing on process mining applications to logistical processes in healthcare settings. Studies screening, data extraction and methodological quality assessment will be conducted using the Mixed Methods Appraisal Tool. Data will be extracted on key dimensions and performance indicators and will be presented in a structured format. A narrative synthesis will be conducted, and findings will be categorised and thematically analysed where appropriate. Primary outcomes include improvements in logistical efficiency, traceability, resource utilisation and sustainability. Secondary outcomes include implementation challenges, data integration issues and limitations in applying process mining techniques to logistical workflows.

Ethics and dissemination: The results of the systematic review will be disseminated via publication in a peer-reviewed journal and presented at a relevant conference. The data we will use do not include individual patient data, so ethical approval is not required.

Prospero registration number: CRD420251164812.

Introduction: High costs of screening and diagnostic tests remain a major barrier to timely tuberculosis (TB) identification in resource-limited settings. Evidence on the cost-effectiveness of scalable screening algorithms is limited. Start4All is a research project aimed at developing and evaluating algorithmic approaches to TB screening and diagnosis, with the goal of optimising technical and allocative efficiency when expanding diagnostic coverage to primary healthcare and community settings.

Methods and analysis: Five screening and diagnostic tests will be evaluated: a capillary blood-based assay (C-reactive protein (CRP)), sputum-based rapid molecular tests (PCR; individual and pooled Xpert MTB/RIF Ultra assay (Xpert Ultra, Cepheid®, California, USA)), a lateral-flow urine-based test for lipoarabinomannan (LF-LAM), and digital chest X-rays with artificial intelligence-based computer-aided detection (CXR-CAD). A microbiological reference standard of positive culture using the mycobacteria growth indicator tube will be used to confirm TB disease.We will compare the cost and effectiveness of concurrent and sequential positive serial combinations (screening algorithms) of CRP, CXR-CAD, LF-LAM, individual and pooled Xpert Ultra. Diagnostic performance will be estimated using sensitivity, specificity, predictive values and proportions of positive results, with Bayesian inference used to derive these estimates. The analysis will include adults (15 years and older) only and will be stratified by HIV status and level of care, including facility and community-based case finding. Effectiveness will be assessed based on the number of people with TB detected. Cost analysis will be conducted from the provider perspective, incorporating commodity and implementation costs. A decision tree model will be developed to assess the cost per number of persons with confirmed TB detected across all countries. Probabilistic sensitivity analysis will be conducted to account for uncertainty in model parameters, incorporating willingness-to-pay and willingness-to-accept thresholds.

Ethics and dissemination: WHO ethical review committee approval ERC.0003921. Data will be available on reasonable request to the principal investigator of the consortium.

Trial registration number: NCT05845112.

Introduction: The Optimising older People's Transition from acute care Into residential aged care through Multidisciplinary Assessment and Liaison (OPTIMAL) trial is a multisite hybrid type II stepped wedge randomised controlled trial with an embedded process evaluation that aims to evaluate the effectiveness of implementing a bundle of evidence-based interventions to provide systematic support to older adults being discharged from hospital to residential aged care (RAC) homes for the first time. The trial is based on evidence from models of care used internationally to improve the quality of care transitions and addresses a need to provide evidence of transferability and effectiveness of these models in the Australian context. The embedded process evaluation will assess the acceptability, appropriateness, feasibility, adoption and fidelity of the OPTIMAL intervention, as well as the mechanisms of impact.

Methods and analysis: The OPTIMAL trial will be implemented across the three metropolitan local health networks (LHNs) in South Australia. The process evaluation will be conducted in parallel with the main trial and is theoretically informed by the integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) implementation framework, which theorises that the implementation success of OPTIMAL is determined by the facilitation of the intervention with the intended recipients in their inner and outer contextual setting. The process evaluation will employ a mixed methods approach. Qualitative and quantitative data will be collected through baseline context mapping of LHNs, interviews with key LHN and RAC stakeholders, online survey of clinical teams, fortnightly check-in forms, and activity logs and field notes maintained by the nurse facilitator in each LHN. Data will be mapped and reported based on the i-PARIHS framework.

Ethics and dissemination: Ethical approval for the OPTIMAL trial was obtained from the Southern Adelaide Clinical Human Research Ethics Committee (approval 2023/HRE00111), and the relevant governance approvals were obtained for each participating LHN. Ethical approval includes a waiver of the requirement for consent for routinely collected patient data. Study findings will be disseminated via journal publications, presentations at conferences, stakeholder discussions, consumer forums and advocacy to key decision makers to support knowledge translation.

Trial registration number: Australia New Zealand Clinical Trial Registry, ACTRN12624001008516, registered 20 August 2024.

Objectives: To investigate the impact of residual refraction within ±1.0 dioptre (D) on uncorrected distance visual acuity (UDVA) in pseudophakic eyes.

Design: Cross-sectional study.

Setting: This study was based on retrospectively collected electronic refraction records from a tertiary care academic ophthalmology centre in southern China between May 2022 and July 2025.

Participants: Patients aged ≥40 years who underwent uneventful phacoemulsification cataract surgery with in-the-bag monofocal intraocular lens implantation and achieved a postoperative corrected distance visual acuity (CDVA) of ≤0.1 logarithm of the minimum angle of resolution were enrolled. They were stratified by astigmatism subtypes: minimal astigmatism (<0.50 D), with-the-rule (WTR) astigmatism, against-the-rule (ATR) astigmatism and oblique astigmatism.

Outcomes measures: Postoperative evaluation (≥1 month) included spherical equivalent (SE) refraction, UDVA and CDVA. UDVA was compared across eyes with SE intervals of 0.50 D within ±1.0 D. ORs were calculated to assess the relative risk of failing to achieve a UDVA of 0.1 or better for postoperative SE within ±1.0 D, using 0.00 D as the reference.

Results: The study included 1333 eyes from 1333 patients (mean (SD) age, 66.1 (8.96) years; 532 male (39.9%)). Overall, and particularly in the minimal astigmatism (<0.50 D), ATR astigmatism and oblique astigmatism subgroups, hyperopic eyes exhibited significantly better UDVA than their myopic counterparts. Slight myopia [-0.50 D, 0 D) significantly worsened UDVA versus 0 D in both the overall population and the minimal astigmatism subgroup. Slight hyperopia (0 D, +0.50 D] minimally affected UDVA, whereas an equivalent degree of myopia increased the odds of not achieving UDVA ≤0.1 by 1.55-fold (95% CI 1.08 to 2.21) overall and by 3.14-fold (95% CI 1.49 to 6.58) in the minimal astigmatism subgroup. Additionally, UDVA was optimal with minimal astigmatism and decreased progressively with each 0.50 D increment in residual astigmatism magnitude, a dose-dependent trend consistent across astigmatism subtypes.

Conclusions: The impact of refractive errors (≤1.0 D) on UDVA was associated with the magnitude and type of astigmatism. Residual astigmatism of ≥0.50 D exerted a significant negative effect on UDVA. A plano SE (0 D) was optimal for minimum and WTR astigmatism, whereas slight hyperopia yielded superior UDVA in ATR and oblique astigmatism.