FreshRSS

🔒
☐ ☆ ✇ BMJ Open

Using an outpatient physiotherapist-led behaviour change intervention to promote exercise adherence in people with vertebral fragility fracture: a longitudinal qualitative study

Por: Hannink · E. · Room · J. · Barker · K. L. — Octubre 13th 2025 at 16:51
Objectives

To explore the longitudinal experience of taking part in a physiotherapy-led exercise adherence programme as part of the OsteoPorosis Tailored exercise adherence INtervention (OPTIN) trial.

Design

Longitudinal qualitative study using semi-structured interviews analysed with reflexive thematic analysis—an interpretive approach.

Setting

UK National Health Service.

Participants

12 participants with vertebral fragility fracture (VFF) within the exercise adherence intervention arm of the OPTIN trial (n=63 in each arm). Interviews were undertaken with each participant at three time points: (1) within the first 2 weeks of initial assessment, (2) at the end of the 16-week intervention and (3) a year post-baseline.

Results

We distilled five themes. (1) One size does not fit all: this focuses on the importance of a physiotherapist individualising the exercise programme and how participants adapt it into their lives. (2) My mind and body can be in conflict or work together: this spotlights the strong link between one’s emotional and mental state with their physical state, and how they can work to positively or negatively affect exercise adherence behaviour. (3) Expanding my circle of support: this revolves around the need for support systems beyond family and friends to the physiotherapist and other people with osteoporosis. (4) Transitioning from an exercise programme to a lifestyle change: this encompasses a longitudinal perspective of the exercise programme tapering, becoming intermittent or dropping off after a year, then being replaced by sustained lifestyle changes. (5) Moving from fear to empowerment: this explores the fear and loss of former identity after VFF diagnosis transforming into hope, confidence and empowerment through knowledge, advice and coping strategies.

Conclusions

Findings highlight the need to work with mind and body to empower lifestyle changes and the importance of educating, tailoring, empathising and allying with the participant—all critical areas clinicians can target when treating patients with VFFs.

Trail registration number

ISRCTN14465704.

☐ ☆ ✇ BMJ Open

The leishmaniases in Kenya: a scoping review sub-analysis of diagnostics

Por: OBrien · K. · Grifferty · G. · Shirley · H. · George · S. · Binkley · A. · Orriols · A. M. · Espinola Coombs · P. · Williams · A. L. · Wong · M. G. · Roe · S. · Wallace · F. · Tschoepe · K. · Hirsch · J. L. · Wamai · R. — Octubre 13th 2025 at 16:51
Objectives

Leishmaniasis poses a significant public health problem in Kenya, where effective case management and treatment rely on accurate diagnosis. This review aims to summarise the research landscape on leishmaniasis diagnostics in Kenya and identify gaps.

Design

This scoping review expands a previously published scoping review on leishmaniasis in Kenya to further analyse studies focusing on diagnostics. The field of diagnostics was chosen because of recent pushes for novel tools and because of the role timely diagnosis plays in disease elimination. A comprehensive search of PubMed, Embase via Embase.com, Web of Science Core Collection, the Cochrane Library, ClinicalTrials.gov, WHO ICTRP and the Pan African Clinical Trials Registry was conducted, covering studies up to 5 January 2024.

Results

After dual, blind screening with conflict resolution by a third reviewer, 41 studies were included in the review. These studies examined a range of diagnostic tools; however most were assessed in one or few studies, and none evaluated real-time PCR. Additional gaps in the research landscape include a lack of diagnostics for cutaneous leishmaniasis and post-kala-azar dermal leishmaniasis in Kenya, outdated literature surrounding the Direct Agglutination Test and randomised trials for any diagnostic tool.

Conclusions

Future research should focus on solidifying the validity and reliability of diagnostic tools in the Kenyan context and updating previous work.

☐ ☆ ✇ PLOS ONE Medicine&Health

Conformation of HLA-E/peptide complex guides interaction with two novel HLA-E receptors: Stabilin 1 and 2

by Tom A. W. Schoufour, Linda Voogd, Kees L.M.C. Franken, Tom H.M. Ottenhoff, Ruud H.M. Wijdeven, Simone A. Joosten

Human leukocyte antigen E (HLA-E) communicates cellular health to natural killer (NK) cells through presentation of peptides derived from the leader sequence of classical major histocompatibility complex class I (MHC-I), inhibiting NK cell activation and lysis of healthy cells. Besides this canonical role, HLA-E can also present peptides from pathogens such as Mycobacterium tuberculosis (Mtb) to T cells and can inhibit phagocytosis by engaging with LILRB1/2. To identify additional HLA-E binding surface molecules, we utilized a CRISPR/Cas9 activation screen with HLA-E tetramers, which identified Stabilin (STAB)1 and STAB2 as novel interactors. This interaction depended on the nature of the peptide/HLA-E complex, whereby high affinity peptides did not permit the interaction while low affinity peptides did. Functionally, expression of STAB1 or STAB2 on THP-1 monocytes increased phagocytic uptake of HLA-E coated microbeads. These results provide the first evidence of an interaction between Stabilin receptors and specific HLA-E conformations.
☐ ☆ ✇ BMJ Open

Symptom tracking for endometriosis: a systematic review protocol for mobile applications focused on content, inclusivity and features

Por: Ortoleva Bucher · C. · Martin · L. A. · De Santo · A. · Pluchino · N. · Rio · L. — Octubre 10th 2025 at 11:24
Background

Endometriosis is a chronic gynaecological condition affecting 2%–10% of women worldwide, often leading to severe pain, organ dysfunction and infertility. Despite its prevalence, diagnosis is frequently delayed, and treatment options remain limited. Mobile health (mHealth) applications have gained popularity as tools for symptom tracking, yet concerns about their accessibility, evidence-based content and inclusivity persist. Ensuring that these digital tools are culturally relevant, user-friendly and available to diverse populations is crucial for improving patient care and engagement. This study aims to systematically review mobile applications designed for tracking endometriosis symptoms, with a focus on content quality, inclusivity and functionality. The objective is to identify gaps in existing apps and provide recommendations for developing more inclusive digital health solutions.

Method

This study follows a systematic review methodology proposed by Gasteiger et al. The research process consists of seven steps, including defining research questions, identifying relevant applications, determining eligibility criteria, selecting and analysing apps and synthesising results. The apps will be sourced from the Apple App Store and Google Play Store via predefined search strategies. The evaluation criteria include content accuracy, usability, inclusivity, privacy protection and adherence to evidence-based medical guidelines. Data extraction focuses on app characteristics, including language availability, user accessibility, evidence-based symptom tracking and adherence to health equity principles. The Mobile App Rating Scale will be used to assess usability, functionality, aesthetics and information quality. The findings will be systematically compared to identify strengths, limitations and areas for improvement in existing applications.

Discussion

This systematic review of applications offers an overview of available apps that can be downloaded in Switzerland. Furthermore, it will present a detailed analysis of those that are specifically geared towards symptom tracking and will evaluate the level of evidence-based content, inclusivity, data protection and quality. A key strength of this review is its multidisciplinary approach, which involves engaging experts in healthcare, digital technology, inclusivity and individuals with lived experiences with endometriosis.

Ethics and dissemination

Approval from an ethics committee is not required. Data and material will be available on request from the authors.

☐ ☆ ✇ BMJ Open

Study protocol for a multicentre, randomised controlled trial in China to evaluate the efficacy and safety of precise subsegmental bronchoscopic thermal vapour ablation treatment in severe emphysema

Por: Yang · H. · Chen · S. · Ye · L. · Herth · F. J. · Sun · J. — Octubre 9th 2025 at 10:17
Introduction

Bronchoscopic thermal vapour ablation (BTVA) is a bronchoscopic lung volume reduction technique, also recommended by the global initiative for chronic obstructive lung disease (GOLD) guidelines. Previous studies on BTVA have primarily focused on segmental treatment, targeting the most severely affected lung segments while preserving healthier areas. However, there is considerable variability in the severity of emphysema within subsegments of these lung segments, suggesting that a more precise approach could potentially improve treatment outcomes. This study aims to evaluate the efficacy and safety of subsegmental BTVA, which may better preserve healthy lung tissue while more accurately targeting the most severely affected regions in patients with severe emphysema.

Methods and analysis

This is a prospective, multicentre, randomised, controlled, open-label clinical trial conducted in China. A total of 100 patients with severe emphysema, who continue to experience significant symptoms despite optimal medical therapy according to GOLD guidelines, will be enrolled. Participants will be randomly assigned in a 1:1 ratio to either the experimental group (subsegmental BTVA) or the control group (segmental BTVA), both receiving optimal medical therapy. BTVA will be performed in two separate procedures, with the second procedure occurring at least 6 weeks and no more than 6 months after the first. The primary endpoint is the change in forced expiratory volume in 1 s at 6 months following the second procedure. Secondary endpoints include changes in lung volumes, quality of life (measured by the St. George’s respiratory questionnaire for chronic obstructive pulmonary disease patients), other parameters in pulmonary function tests, and 6 min walk distance at 6 and 12 months, etc.

Ethics and dissemination

The trial protocol was approved by the Ethics Committee of Shanghai Chest Hospital (IS23073). Additionally, study approval was obtained from local regulatory boards at each site before the study commenced. The results will be published in a peer-reviewed journal.

Trial registration number

This trial was registered on ClinicalTrials.gov on 16 November 2023 (NCT06152107).

☐ ☆ ✇ BMJ Open

Rebozo and maternal postures to prevent persistent occiput posterior position of the fetal head: protocol for a randomised clinical trial 'the ReMaP-POPP RCT

Por: Ornaghi · S. · Fumagalli · S. · Antolini · L. · Panzeri · M. · Spandrio · R. · Ferrini · S. · Nespoli · A. · Maini · M. · Locatelli · A. — Octubre 9th 2025 at 10:17
Introduction

Occiput posterior position is the most common fetal malposition, complicating up to 35% of initial labours, and its persistence can lead to increased risks of adverse maternal and perinatal outcomes. The role of maternal postures, such as lateral recumbent and hands-and-knees, in promoting the anterior rotation of the fetal head has been investigated in several randomised trials in the last two decades, with mostly negative results. However, both methodological and study design limitations may have contributed to such findings. Recently, the use of forward-leaning inversion and side-lying release procedures and of the Rebozo technique has been implemented into clinical practice as a non-invasive alternative to promote the anterior rotation of the fetal head. Yet, neither intervention has been rigorously assessed in a controlled study. Our aim is to conduct a randomised controlled trial to assess whether a combination of forward-leaning inversion and side-lying release procedures and the Rebozo technique in a pre-specified sequence during the first stage of labour of women with a posterior fetus would favour its anterior rotation.

Methods and analyses

The ReMaP-POPP (Rebozo and maternal procedures to prevent persistent occiput posterior position of the fetal head) trial will be an open-label single-centre randomised controlled trial with two parallel groups. Women will be eligible if they are ≥18 years old, in labour (3 to 8 cm) and with a singleton term fetus (≥370/7 weeks) in an occiput posterior position confirmed by transabdominal sonography. Eligible women will be randomised into two groups: (1) intervention, a sequence of forward-leaning inversion and side-lying release procedures and Rebozo technique (duration 90–105 min); and (2) control, standard of care (maternal postures, including upright, lateral recumbent and hands-and-knees). Blinding will be guaranteed only for the physician assessing the fetal head position by sonography. Randomisation will be performed using randomly permuted blocks of varying sizes (4, 6 and 8), stratified by parity, in a 1:1 ratio. The primary outcome will be the probability of occiput posterior position of the fetal head 3 hours and 30 min after randomisation, diagnosed by sonography. Secondary outcomes will include the probability of occiput posterior position at full cervical dilation and at birth, maternal and neonatal health-related outcomes, as well as maternal pain intensity and ability to cope with pain and birth satisfaction level. We will also assess safety outcomes regarding challenges in adequate fetal heart rate monitoring during the time interval between randomisation and primary outcome assessment. Sample size estimation considered the possibility to decrease the probability of occiput posterior position from 35.8% (control, based on prior retrospective data at our Institution) to 22% with the proposed intervention. With a power of 0.90 and a two-sided value of 0.05, the estimated sample size will be n=462 (n=231/arm). Considering a potential attrition rate of 20%, n=578 women will be needed. Enrolment will require approximately 16 months. Primary and secondary outcomes will be analysed on an intention-to-treat basis. The effects of the intervention will be estimated by relative risks and their 95% CI.

Ethics and dissemination

The study has been approved by the Lombardy Ethics Committee n.3 (n. 5499, 20 December 2024). Written informed consent will be obtained from all participants. Women will be free to decline participation or to withdraw at any time. Findings will be presented at scientific meetings and published in peer-reviewed scientific journals in the field of midwifery and obstetrics. Also, they will be disseminated to the public through outreach activities involving families and healthcare specialists.

Trial registration number

The study has been registered in the Clinical Trials database (NCT06887634).

☐ ☆ ✇ BMJ Open

Current pesticide suicide surveillance methods used across the African continent: a scoping review

Por: Jonker · M. · Karunarathne · A. · Utyasheva · L. · Eddleston · M. · Konradsen · F. · Rother · H.-A. — Octubre 9th 2025 at 10:17
Background

Suicide poses a significant global health challenge in low- and middle-income countries and is a leading cause of death worldwide. Although global suicide rates have decreased by 36% between 2000 and 2019, the decline in Africa has not been as substantial. Suicide surveillance data, particularly from pesticide ingestion, is lacking.

Objectives

This scoping review aimed to identify pesticide suicide surveillance methods currently used in African countries and to assess their viability for improving reporting of pesticide suicide deaths.

Design

A scoping review was conducted using a five-stage methodological framework across several databases.

Eligibility criteria

Peer-reviewed articles published in English that investigated (a) pesticide poisoning and (b) suicide in humans only and specific to the African continent.

Sources of evidence

MEDLINE (via PubMed), Scopus (with substantial Embase content), Web of Science Core Collection, Biological Abstracts, SciELO (on Web of Science platform), Academic Search Premier, Africa-Wide Information, Biological and Agricultural Index, CINAHL, Health Source Nursing/Academic, APA PsycInfo and General Science (EBSCOhost platform). The search was performed in January 2022, and the review of the results took place from February to May 2022.

Data charting methods

All authors developed and tested the data extraction tool. The charting framework remained dynamic, continuously updated as reviewers gained a deeper understanding of the studies included. Four independent reviewers charted the data to ensure inter-rater reliability. To address discrepancies, a sample of eligible articles was cross-rated by the reviewers.

Results

We identified 110 relevant studies describing eight different surveillance systems, conducted in 30 different African countries. Of these studies, 50.1% (56/110) reported on the number of pesticide suicides (totalling 1554); however, 49% (54/110) did not differentiate the cause of death further than either a poisoning death or a suicide, making it difficult to determine if pesticides were involved in the death or if the death was an intentional poisoning case. The surveillance systems identified included health facility records (hospital admissions data), poison control centre (PCC) data, forensic/mortuary data (including police reports), media reports, surveys/interviews with patient/family, case reports, systematic/literature reviews and civil registration and vital statistics (CRVS) data. Hospital admissions data was the most frequently used surveillance system (61/110, 55.5%).

Conclusions

The number of studies and surveillance methods found was higher than anticipated. While this is a positive sign, several areas of improvement were identified for pesticide suicide surveillance in Africa. These included improving reporting of the specific pesticides (including the active ingredient) linked to suicide cases for improving policy (since this is required for pesticide regulation) and making use of more than one surveillance system to enhance surveillance of pesticide suicides, allowing for under-used sources, such as PCCs, to be used more effectively in pesticide suicide surveillance. Finally, although a comparison of these surveillance methods outside of Africa was not directly possible for each surveillance system due to a lack of similar high-quality reviews, we did refer to publications where similar pesticide suicide surveillance systems were discussed.

☐ ☆ ✇ BMJ Open

Perceived Social Risk Scale: development and validation in relation to social status and depression in the UK

Por: Newton · J. · Andrews · J. L. — Octubre 9th 2025 at 10:17
Objective

To develop and validate the Perceived Social Risk Scale (PSRS) for assessing perceptions of socially risky behaviours, and to validate it against existing psychological measures such as perceived social status and depressive symptoms in a UK sample of older adolescents and adults.

Design

A cross-sectional study involving exploratory and confirmatory factor analyses.

Setting

Participants were recruited from the Cardiff University’s Department of Psychology participant pool (students completing studies for course credit) and Prolific Academic (a crowdsourcing platform for research volunteers). Data collection occurred between 17 February and 6 May 2024.

Participants

A total of 640 UK participants, including both men and women, aged 18-65.

Main outcome measures

We measured the internal consistency of the PSRS, test-retest reliability and validity against measures including rejection sensitivity, perceived social status, depressive symptoms and resistance to peer influence. Moderation analyses examined the role of perceived social status, age and a sense of belonging in the relationship between PSRS scores and depressive symptoms.

Results

The PSRS showed excellent internal consistency (α=0.96) and good test-retest reliability (Intraclass Correlation Coefficient (ICC)=0.70). Perceptions of social risks significantly declined with age (r=–0.20, p) and factor analyses confirmed that the PSRS differentiates among four distinct but related social risk constructs: authenticity and integrity (α=0.91), social assertiveness (α=0.72), reservedness (α=0.83) and social non-conformity (α=0.72). For evidence of convergent validity, higher PSRS scores were associated with increased sensitivity to social rejection (r=0.23, p elevated depressive symptoms (r=0.13, p=0.012) and negatively correlated with resistance to peer influence (r=–0.13, p=0.013). Local perceived social status significantly moderated the relationship between PSRS scores and depressive symptoms (β=0.005, SE=0.002, t=2.36, p=0.019). A general sense of belonging did not moderate this relationship.

Conclusions

Our results confirm that social risk is not a uniform construct but is instead multidimensional. The PSRS offers a reliable and valid tool for assessing multidimensional social risk-taking, with strong internal consistency and test–retest reliability. The interaction between depression and local perceived social status highlights the importance of perceived status on social risk perception.

☐ ☆ ✇ BMJ Open

Cost analysis of post-stroke dysphagia during acute hospitalisation: a cross-sectional study in Vietnam

Por: Thong · T. H. · Hien · N. T. T. · Tung · L. T. · Thang · P. · Trung · T. H. · Tien · V. D. · Hanh · H. T. · Lam · T. H. — Octubre 8th 2025 at 05:59
Objectives

To estimate the healthcare costs associated with post-stroke dysphagia during acute hospitalisation and to identify factors influencing these costs in a tertiary hospital setting in Vietnam.

Design

A cross-sectional study using clinical and billing data from hospital records.

Setting

The study was conducted at the Neurology Center of Bach Mai Hospital, a tertiary care facility in Hanoi, Vietnam, between June 2020 and January 2022.

Participants

A total of 951 patients aged ≥18 years with acute ischaemic stroke confirmed by CT or MRI were included. Dysphagia was assessed using the Gugging Swallowing Screen.

Outcome measures

Direct healthcare costs during hospitalisation were collected from the hospital billing system and categorised as medications, diagnostic imaging, medical supplies, accommodation, food, procedures and laboratory tests. All costs were converted to USD. Associations between patient characteristics and total healthcare costs were analysed using generalised linear models (Gamma distribution with log link), applying robust standard errors.

Results

The median treatment cost was 10.08 million VND (436.24 USD) in the dysphagia group vs 6.37 million VND (275.78 USD) in the non-dysphagia group. Costs increased with dysphagia severity, reaching 22.64 million VND (979.49 USD) among patients with severe dysphagia. In multivariate analysis, dysphagia was associated with a 21% increase in costs (exp(β) = 1.21; 95% CI 1.10 to 1.33; p14, pneumonia, prolonged hospitalisation and higher educational level.

Conclusions

Post-stroke dysphagia substantially increases acute hospitalisation costs in Vietnam. Early screening, standardised management and preventive care for complications may improve outcomes and reduce costs.

Trial registration number

The study was registered on the Research Registry website (https://www.researchregistry.com/) under the unique identification number: researchregistry8203.

☐ ☆ ✇ BMJ Open

Impact of telemedicine on reducing travel-related CO2 emissions in chronic disease care: a cross-sectional study in Northeast Brazil

Por: Gadenz · S. D. · Sperling · S. · Moraes · L. B. · Bezerra · V. R. · Motter · F. R. — Octubre 8th 2025 at 05:59
Objective

This study aimed to estimate reductions in travel-related carbon dioxide (CO2) emissions, travel time and distance resulting from a telemedicine service for patients with chronic conditions, and to assess its potential to contribute to more equitable access to specialised care in Northeast Brazil.

Design

Cross-sectional study.

Setting

Primary healthcare units in the Northeast region of Brazil.

Participants

Patients between birth and 104 years of age with chronic conditions who received video-based teleconsultations between June 2022 and November 2023.

Primary and secondary outcome measures

The primary outcome was the reduction in travel-related carbon emissions due to avoided in-person referrals. Secondary outcomes included travel time and travel distance savings. Round-trip distances between primary healthcare units and referral centres were estimated using geolocation data. CO2 emissions were calculated using the Greenhouse Gas (GHG) Protocol adapted to Brazil (Brazilian GHG Protocol Programme), focusing on Scope 3 emissions from patient travel.

Results

A total of 4642 teleconsultations were conducted with 4106 patients. Of these, 4021 (86.6%) avoided in-person referrals, resulting in estimated savings of 226 900 miles in travel distance and 488 584 min in travel time. The estimated CO2 emissions avoided totalled 21 593 kg (21 930 kg CO2 equivalent), with a mean of 5.37 kg (SD±5.5) per teleconsultation (5.4 kg CO2 equivalent ; SD±5.5). Greater travel distance savings were observed among patients living in municipalities with lower Municipal Human Development Index (mean 92.3±104.2 miles vs 17.3±8.4 miles; p

Conclusions

Telemedicine use in Northeast Brazil significantly reduced patient travel, leading to substantial savings in CO2 emissions. These savings were more pronounced for patients in smaller, less developed municipalities. By reducing the need for travel, telemedicine can improve access to healthcare for remote or underserved populations, while also supporting environmental sustainability.

☐ ☆ ✇ BMJ Open

Effects of compression therapy on the upper limb of patients with stroke: a systematic review protocol

Por: Lee · J. M. · Chai · S. C. · Shi · D. · Gan · K. B. · Chu · S. Y. · Li · K. · Lim · A. L. — Octubre 8th 2025 at 05:59
Introduction

Stroke is a leading cause of disability and mortality worldwide, with upper limb dysfunction being among its most common effects. Compression therapy has recently gained growing interest as an adjunct to other rehabilitation interventions for managing upper limb dysfunction among stroke survivors. However, the evidence for its effectiveness remains inconsistent and equivocal. Therefore, this systematic review aims to assess the effectiveness of compression therapy in managing upper limb dysfunction in patients with stroke.

Method

A systematic search of databases (PubMed, Scopus, Web of Science, CINAHL, Cochrane Library, Embase, PEDro, OTseeker, ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform) will be conducted to identify peer-reviewed studies and relevant grey literature on compression therapy on upper limb dysfunction after stroke. Two reviewers will independently screen, select and extract data, with discrepancies resolved through discussion or involvement of a third reviewer. Outcomes of interest include clinical measures of upper limb function, activity, participation and safety (ie, adverse effects). Risk of bias will be assessed using the Cochrane RoB 2 for randomised studies, the Risk Of Bias In Non-randomised Studies of Interventions for non-randomised studies. The certainty of evidence across types of compression therapy and outcomes will be evaluated using the Grading of Recommendations, Assessment, Development and Evaluation approach. Data will be narratively synthesised, and a meta-analysis will be performed if feasible. The review will be reported following the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines and will be conducted from September 2025 to December 2025.

Ethics and dissemination

This systematic review does not require ethical approval as only secondary data will be used. This review will synthesise the body of evidence on the effectiveness of compression therapy in managing poststroke upper limb dysfunction. Results will then be disseminated through a peer-reviewed publication to inform research and clinical practice.

PROSPERO registration number

CRD42024625815.

☐ ☆ ✇ BMJ Open

Study protocol for the DISTINCT trial: inDividual, targeted thrombosIS prophylaxis versus the standard 'one-size-fits-all approach in patients undergoing Total hIp or total kNee replaCemenT - a national, multicentre, randomised, multiarm, open-label trial

Por: Kok · R. Y. · van Bodegom-Vos · L. · Ettema · H. B. · Groenwold · R. H. H. · van den Hout · W. B. · Huisman · M. V. · Klok · F. A. · Nelissen · R. G. H. H. · van Rein · N. · van Veen · M. · Vehmeijer · S. B. W. · Wiegerinck · J. J. I. · Cannegieter · S. C. · Nemeth · B. — Octubre 7th 2025 at 08:15
Introduction

Patients undergoing total hip arthroplasty (THA) and total knee arthroplasty (TKA) are considered to have a symptomatic venous thromboembolism (VTE) risk of 1.0%–1.5% despite thromboprophylaxis. Fast-track treatment protocols have substantially lowered the VTE risk in most patients. Hence, the majority of patients may be unnecessarily exposed to the burden and risk of thromboprophylaxis. On the contrary, there are still patients with a high VTE risk who develop VTE despite thromboprophylaxis. Thus, tailored thromboprophylaxis treatment may potentially reduce both VTE and bleeding risk.

Methods and analysis

The DISTINCT (inDividual, targeted thrombosIS prophylaxis versus the standard ‘one-size-fits-all’ approach in patients undergoing Total hIp or total kNee replaCemenT) trial is a national, multicentre, randomised, multiarm, open-label trial. The main objective is to study whether tailored thromboprophylaxis reduces the occurrence of symptomatic VTE (primary outcome) and major bleeding (primary safety outcome) within 90 days after THA/TKA in comparison with standard thromboprophylaxis. Patients with a low, intermediate or high predicted VTE risk (based on the Thrombosis Risk Prediction following total hip and knee arthroplasty score (TRiP(plasty) score)) will be included in the DISTINCT-1, DISTINCT-2 or DISTINCT-3 studies, respectively. In the DISTINCT-1 trial, 3478 patients will be randomly allocated to receive either in-hospital thromboprophylaxis or standard prophylaxis. In the DISTINCT-2 cohort study, 2500 patients will receive standard prophylaxis. In the DISTINCT-3 trial, 4100 patients will be randomly allocated to receive either 6 weeks of high-dose thromboprophylaxis or standard prophylaxis. Standard prophylaxis consists of a low dose of any approved thromboprophylactic agent for 4 weeks. We hypothesise that (1) the efficacy of in-hospital only thromboprophylaxis is non-inferior in preventing VTE and equally safe compared with standard prophylaxis in patients with a low VTE risk (DISTINCT-1) and (2) prolonged high-dose thromboprophylaxis is superior in preventing VTE as compared with standard prophylaxis in patients with a high VTE risk (DISTINCT-3). Patients with intermediate VTE risk will be observed to evaluate VTE and bleeding rates (DISTINCT-2).

Ethics and dissemination

The protocol has been approved by the Medical Research Ethics Committee Leiden-Den Haag-Delft, EU-trial-number 2023-510186-98. Study results will be disseminated through peer-reviewed journals and during international conferences.

Trial registration number

NCT06581965.

☐ ☆ ✇ BMJ Open

Randomised hybrid type 1 pilot trial evaluating preliminary effectiveness and implementation of an emergency care action plan (ECAP) for infants with medical complexity within a rural health network: a study protocol

Por: Palaza · A. · Callas · P. · Dayan · P. S. · Kuo · D. Z. · Riney · L. · Spencer · S. P. · Stapleton · R. · Stevens · M. · Studts · C. R. · Pulcini · C. D. — Octubre 7th 2025 at 08:15
Introduction

Children with medical complexity (CMC) are a subset of children with special healthcare needs, defined by high healthcare utilisation, severe single or multisystem organ dysfunction, and in many cases, reliance on medical technology. In the emergency care setting, known challenges for this population include poor quality of care, avoidable admissions and high caregiver and provider burden. While experts and professional societies recommend emergency care planning tools to address these concerns, evidence to support effectiveness and implementation of such tools is lacking. Through a human-centred design approach, we recently engaged key partners to create and optimise an emergency care action plan (ECAP) for infants with medical complexity. Here, we describe the protocol for a pilot type 1 hybrid effectiveness-implementation randomised controlled trial (RCT) for infants with medical complexity aimed to evaluate ECAP effectiveness and implementation.

Methods and analysis

Infants with medical complexity and their caregivers will be randomly assigned to the intervention group (ECAP) or control group (standard care) in a pilot type 1 hybrid effectiveness-implementation RCT. The primary outcome is number of inpatient hospital days for infant participants. Additional effectiveness outcomes include perceived avoidance of emergency department (ED) visits, healthcare costs, caregiver stress and self-efficacy. Preliminary implementation outcomes include acceptability, feasibility, appropriateness and usability, as well as contextual barriers and facilitators to reach, adoption and implementation. Key partners, including caregivers of CMC and healthcare providers, will be engaged throughout the implementation of the ECAP and execution of the trial.

Ethics and dissemination

This study was approved by the University of Vermont Institutional Review Board (STUDY00002937). Findings will be disseminated through peer-reviewed publications, conference presentations, and focus groups and interviews with key stakeholders.

Trial registration number

NCT06444282.

☐ ☆ ✇ BMJ Open

Evaluation of natriuresis-guided depletion after cardiac surgery: protocol for a single-centre, open-label, randomised controlled trial--the EASY-CS study

Por: Beyls · C. · Mollet · N. · Gibert · L. · Huette · P. · Khamari · M. · Meynier · J. · Abou-Arab · O. · Mahjoub · Y. — Octubre 7th 2025 at 08:15
Introduction

Fluid overload (FO) is a common complication following cardiac surgery with cardiopulmonary bypass (CPB) and is associated with increased morbidity and mortality. Loop diuretics, particularly furosemide, are widely used to promote sodium and water excretion, but their postoperative use remains largely empirical. International guidelines recommend early assessment of diuretic response using spot urinary sodium concentration, traditionally measured by automated laboratory analysers. Recent advances now enable bedside measurement of natriuresis using point-of-care (POC) urinary sodium sensors. This trial aims to determine whether real-time bedside natriuresis monitoring using a POC device can guide safer and more effective diuretic strategies in the postoperative management of FO.

Materials and methods

The EASY-CS trial is a prospective, single-centre, open-label, randomised controlled trial designed to evaluate whether a natriuresis-guided furosemide titration protocol improves diuresis within 48 hours following cardiac surgery with CPB. A total of 102 adult patients undergoing elective cardiac surgery with CPB and requiring postoperative intravenous (IV) furosemide for FO will be randomised in a 1:1 ratio to either standard care (n=51; furosemide titration based on clinical judgement) or a natriuresis-guided arm (n=51), in which furosemide dosing is adjusted according to urinary sodium concentration. All patients will receive an initial 20 mg dose of IV furosemide. In the intervention group, urinary sodium will be measured every 6 hours using a POC sodium sensor (LAQUAtwin Na+ metre, Horiba, Japan). If the spot urinary sodium is

Secondary outcomes include urinary sodium concentration and urine output at 24 hours, natriuresis at 48 hours, and the venous excess ultrasound score at 48 hours, as determined by transthoracic echocardiography. The study will also assess total loop diuretic dose administered, cumulative fluid balance over 48 hours and the incidence of postoperative complications at day 30, including cardiovascular, renal, respiratory and gastrointestinal events. Safety endpoints include the presence of hypotension, hypokalaemia or acute kidney injury before each diuretic administration. Randomisation will be stratified by EuroSCORE II (

Ethics and dissemination

Ethical approval has been obtained from the Institutional Review Board (IRB) of Amiens University hospital (IRB-ID: 2025-A00925-44). The study’s results will be disseminated through peer-reviewed publications and presentations at national and international conferences.

Trial registration number

ClinicalTrials.gov Identifier: NCT07077772.

☐ ☆ ✇ BMJ Open

Barriers to mental health services for children and adolescents with autism spectrum disorder in Brazil: protocol for a qualitative evidence synthesis and citizen panel (BARRIER-Free-BR Project)

Por: Lopes · L. P. N. · Boeira · L. d. S. · Figueiredo Modesto · A. C. · Ramos-Silva · A. · Menin · V. P. · Abe · F. C. · Lopes · L. C. — Octubre 7th 2025 at 08:15
Introduction

The perspectives of stakeholders directly affected by mental health services for autism spectrum disorder (ASD) are essential for the quality of these services. However, it is crucial that these perspectives are informed by the best available evidence and adapted to the local context. This study aims to analyse barriers related to mental health services for children and adolescents with ASD from the perspective of families and caregivers, considering social, racial and gender aspects.

Methods

Three steps will be taken: stakeholder engagement through an online meeting to refine the research question and understand the magnitude of the problem; (b) qualitative evidence synthesis using five databases and grey literature to identify studies that have collected and analysed qualitative data on barriers to mental health services for children and adolescents with ASD in Brazil. Only studies conducted in Brazil that consider the perspectives of family members and caregivers will be included. (c) A citizen panel with families of children and adolescents with ASD will be used to discuss and validate the synthesis findings.

Ethics and dissemination

We will provide a set of evidence-informed and stakeholder-experienced barriers to mental health services for children with ASD in Brazil. This represents an effort to engage stakeholders in evidence descriptions to inform policy. We plan to disseminate the findings through various means, including peer-reviewed journal publications, presentations at national conferences, invited workshops and webinars, patient associations and academic social media platforms. The project was approved by the Ethics Committee for Research at the University of Sorocaba (approval number 78747224.7.0000.5500).

Trial registration number

Open Science Framework—10.17605/OSF.IO/DVAKG.

☐ ☆ ✇ BMJ Open

Effects of photobiomodulation therapy combined with static magnetic field on pain and function in patients with lateral epicondylitis: a multicentre, randomised, placebo-controlled trial

Por: de Oliveira · M. F. D. · Leal-Junior · E. C. P. · Machado · C. d. S. M. · Ribeiro · N. F. · Dias · L. B. · Lino · M. M. A. · Araujo-Silva · O. M. · Casalechi · H. L. · Johnson · D. S. · Tomazoni · S. S. — Octubre 6th 2025 at 02:14
Introduction

Photobiomodulation therapy (PBMT), particularly when combined with a static magnetic field (PBMT-sMF), is a promising non-pharmacological approach for managing musculoskeletal disorders. However, high-quality evidence for its efficacy in lateral epicondylitis remains limited.

Objectives

The study aims to investigate the effectiveness of PBMT-sMF vs placebo in reducing pain, improving function and modulating inflammatory markers in individuals with lateral epicondylitis.

Design

Multicentre, randomised, triple-blinded, placebo-controlled trial.

Setting

Three outpatient physiotherapy clinics in Brazil.

Participants

50 adults (18–50 years) with unilateral lateral epicondylitis and baseline pain ≥50 on the visual analogue scale (VAS).

Interventions

Participants received either active PBMT-sMF (n=25) or placebo (n=25), 2 times per week for 3 weeks. PBMT-sMF involved multi-wavelength irradiation at 4 epicondyle sites (60 s; 27.1 J/site). The placebo group underwent the same procedure without active irradiation.

Primary and secondary outcome measures

The primary outcome was degree of pain rating (VAS). Secondary outcomes included forearm disability (Patient-Rated Tennis Elbow Evaluation, PRTEE), grip strength, serum tumour necrosis factor-alpha (TNF-α) levels and treatment satisfaction. Assessments were conducted at baseline, post-treatment (3 weeks) and at 4-week follow-up.

Results

PBMT-sMF yielded a higher responder rate (defined as the proportion of participants achieving at least a 30% reduction in pain intensity relative to baseline) than placebo (72% vs 40%, p=0.045), with a clinically and statistically significant between-group difference. Compared with placebo, the PBMT-sMF group showed significantly greater reductions in pain intensity both at the end of treatment (51.4±19.8 vs 36.9±22.6; p=0.0223) and at follow-up (37.4±24.1 vs 20.3±21.2; p=0.0049). TNF-α levels also decreased significantly in the PBMT-sMF group compared with placebo at both time points (p

Conclusions

PBMT-sMF significantly reduced pain intensity and TNF-α levels, suggesting an anti-inflammatory mechanism. Although functional outcomes were not improved, PBMT-sMF may be a valuable short-term, non-invasive option for lateral epicondylitis pain management.

Trial registration number

NCT04829734 on ClinicalTrials.gov

☐ ☆ ✇ BMJ Open

Comparative efficacy and safety of high-dose rifamycin regimens for tuberculosis treatment: a Bayesian network meta-analysis

Por: Feng · Z. · Wu · H. · Li · Q. · Zhang · X. · He · Q. · Wang · H. · Yu · J. · Ge · S. · Song · L. · Zhang · Y. · Zhou · X. · Sun · F. · Zhang · J. · Li · Y. · Zhang · W. — Octubre 6th 2025 at 02:14
Objectives

High-dose rifamycin (HDR) regimens have demonstrated significant potential in tuberculosis (TB) treatment. This study aims to evaluate the efficacy and safety profile of different HDR regimens.

Design

Using a systematic review and Bayesian network meta-analysis (NMA).

Data sources

PubMed, Web of Science, Cochrane Library and Embase were searched up to 2 November 2024.

Eligibility criteria for selecting studies

Randomised controlled trials that compared the efficacy and safety of HDR regimens (rifampin 15–30 mg/kg/day and rifapentine 7.5–20 mg/kg/day) to standard-dose rifampin in patients with pulmonary drug-susceptible TB were included.

Data extraction and synthesis

The risk of bias was assessed using Cochrane tools. We conducted NMA with GEMTC in R. The simulation was performed using the Markov Chain Monte Carlo technique set on four parallel chains, with 20 000 burn-in iterations, 50 000 inference iterations and a thinning factor of n=2.5. To check for model convergence, Gelman and Rubin diagnostic plots and density plots were applied. We assessed heterogeneity using the I² test, evaluated transitivity by comparing effect modifiers across studies and examined consistency via node-splitting analysis. The confidence in network meta-analysis online tool and Cochrane Risk of Bias 2.0 Tool were used to assess evidence certainty and risk of bias, respectively. Higher surface area under the cumulative rank curve scores indicated a higher probability of top-ranking treatments.

Results

Out of 15 766 citations screened, 15 randomised controlled trials were included, encompassing 6456 subjects. The risk of bias was low in 14 studies, with some concerns in one. Patients receiving rifapentine 20 mg/kg/day (risk ratio, 1.09; 95% credible interval, 1.03 to 1.17) had higher culture conversion rates at 8 weeks in solid culture compared with the control. There was no significant difference in primary efficacy within all HDR regimens. Rifapentine 20 mg/kg/day was ranked as the most effective intervention for primary efficacy. No statistical difference in the incidence of serious adverse events was found between all regimens.

Conclusions

Rifapentine 20 mg/kg/day may be the most effective for achieving the strongest anti-TB activity. All HDR regimens demonstrated good safety.

PROSPERO registration number

CRD42024504575.

☐ ☆ ✇ BMJ Open

Knowledge and attitude of parents towards the human papillomavirus vaccine for their daughters and associated factors in Debre Tabor town, northwest Ethiopia: a community-based cross-sectional study

Por: Aragaw · G. M. · Aynalem · G. L. · Abiy · S. A. · Taye · E. B. · Chernet · S. A. · Haile · T. T. · Tsega · N. T. · Mesele · T. T. · Seyoum · A. T. · Tsega · A. G. · Mengistie · B. A. — Octubre 6th 2025 at 02:14
Objective

This study aims to assess parents’ knowledge and attitude towards the human papillomavirus (HPV) vaccination of their daughters and the associated factors in Debre Tabor town, northwest Ethiopia.

Design

A community-based cross-sectional study.

Setting

Debre Tabor town, Northwest Ethiopia.

Participants

A total of 702 participants were included in the study, with a response rate of 98.2%. Three out of the six kebeles in the town were randomly selected, and participants within the selected kebeles were recruited through a cluster sampling technique. An interviewer-administered structured questionnaire was used to collect data from 15 December 2021 to 15 February 2022.

Primary and secondary outcome measures

Parents’ level of knowledge and attitude towards the HPV vaccination of their daughters, and the associated factors.

Results

In the study, parents’ knowledge and attitude towards HPV vaccination were found to be 46.4% (95% CI 42.7% to 50.1%) and 61.5% (95% CI 58.0% to 65.2%), respectively. Parents with a higher level of education (adjusted OR (AOR)=2.27; 95% CI 1.39 to 3.69), media exposure (AOR=3.36; 95% CI 1.21 to 9.33) and a good attitude towards the HPV vaccine (AOR=8.81; 95% CI 5.78 to 13.44) were significantly associated factors that affect parents’ level of knowledge. Positive subjective norms (AOR=1.53; 95% CI 1.01 to 2.31) and perceived behavioural control towards the HPV vaccine (AOR=3.48; 95% CI 2.37 to 5.10) had statistically significant associations with parents’ attitude.

Conclusions

In this study, more than half of parents had poor knowledge of the HPV and its vaccination, while the majority of the participants showed a favourable attitude to the vaccine. Educational attainment, media exposure and a positive attitude were significantly associated with parental knowledge, and parents’ attitude was positively influenced by subjective norms and perceived behavioural control. This suggests a need to increase the parents’ level of awareness through educational interventions, particularly via media and community engagement. To improve the acceptance and uptake of the HPV vaccination, it is important to address negative attitudes and common misconceptions among parents on the safety, efficacy and necessity of the vaccine for their daughters.

☐ ☆ ✇ BMJ Open

How do metacognitive beliefs about memory differ between older adults with low and high dementia worry? A focus group study

Por: Lund · A. E. · von Stein zu Nord- und Ostheim · A. F. · Ridley · H. · Bobyreva · K. · Foster · J. L. H. · Russell · C. — Octubre 3rd 2025 at 06:32
Objectives

This study aimed to examine how older adults form beliefs about their memory and how these beliefs are influenced by their level of concern about dementia. Inaccurate beliefs and excessive worrying, indicative of erroneous metacognition, are associated with negative health outcomes. This research can help identify mitigation for these harmful effects.

Design

Qualitative focus groups; thematic analysis.

Setting

Focus group discussion with healthy older adults hosted at a university in central London.

Participants

35 healthy older individuals (women=29) without any psychiatric or neurological diagnoses, over the age of 65 years (mean 75.31, SD: 6.15). 13 participants were identified as having a high level of worry about dementia and 22 as having low worry. Groups were matched for cognitive performance on the Telephone Mini Addenbrooke’s cognitive assessment (Tele-MACE).

Outcome measures

Participants were assigned to a focus group depending on their level of worry about dementia. During focus groups, a vignette prompted discussion around lifespan changes in memory and how this affected concerns around memory. This allowed investigation of the differences in beliefs about memory.

Results

Thematic analysis revealed two key themes. First, older adults appear to base their definition of ‘normality’ of their own memory on comparisons. These comparisons were between themselves and others and between themselves now and their own past self. Despite similar strategies to define ‘normality’, those with high dementia worry had stricter definitions of what they determined as normal. The second theme described narratives around the ‘self’ and the ‘other’. There was a difference between those with high versus low worry; those with high worry had a strong focus on the ‘self’, while those with low dementia worry focused on ‘others’.

Conclusion

Comparison is a common metacognitive strategy used in forming beliefs about memory. Targeting the use of comparison is potentially valuable in interventions aiming to alleviate older adults’ memory concerns. Addressing self-focused thinking, for example, with cognitive behavioural therapy, could improve harmful levels of high worry.

☐ ☆ ✇ BMJ Open

Getting recovery right after neck dissection for head and neck cancer (GRRAND): trial protocol for a multicentre, pragmatic randomised controlled trial with health economic evaluation and process evaluation

Por: Evans · C. · Greene · L. · Hossain · A. · Klear · P. · Ratna · M. · Bradley · H. · Lall · R. · Mistry · H. · Naghdi · S. · Reategui · M. · Stevens · T. · Bruce · J. · Price · R. · Schache · A. · Dean · S. G. · Lamb · S. E. · Smith · T. · Winter · S. C. — Octubre 3rd 2025 at 06:32
Introduction

Head and neck cancer (HNC) affects the mouth, throat, salivary glands, voice box, nose or sinuses. Every year, over 12 000 people in the UK are diagnosed with HNC. Neck dissection is a key, surgical component of patient care. However, many people experience postoperative restriction in shoulder and neck movements, pain, fatigue and low mood, with only half ever returning to work.

Methods and analysis

Getting Recovery Right After Neck Dissection (GRRAND) is a two-arm, multicentre, pragmatic randomised controlled trial. The trial aims to compare clinical and cost-effectiveness of a personalised physiotherapy programme (GRRAND programme) versus usual practice, National Health Service (NHS), postdischarge care.

The planned sample size is 390 participants. Participants will be recruited from across UK sites and followed up for 12 months. The primary outcome is the shoulder pain and disability index at 12 months. Economic evaluation will be conducted from a healthcare system and personal social services perspective. Secondary outcome data, including pain, function, health-related quality of life, mental well-being, health resource use and adverse events, will be collected at 6 weeks, 3, 6 and 12 months, with exercise adherence at 6 weeks. A process evaluation will determine how GRRAND is implemented, delivered and received across clinical settings, exploring what works, for whom and under what conditions. Analysis will be on an intention-to-treat basis and reported inline with the Consolidated Standards of Reporting Trials statement.

Ethics and dissemination

The trial was approved by the London-Brent Research Ethics Committee (ref: 24/LO/0722) on 15 October 2024. Trial results will be disseminated via peer-reviewed publications, presentations at national and international conferences, in lay summaries and social media. This protocol adheres to the recommended Standard Protocol Items: Recommendations for Interventional Trials checklist.

Trial registration number

ISRCTN13855775.

❌