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☐ ☆ ✇ BMJ Open

Comparative effectiveness and safety of digital health delivery models for pulmonary rehabilitation in patients with chronic obstructive pulmonary disease: a protocol for systematic review and network meta-analysis of randomised controlled trials

Por: Xu · L. · Chen · X. · Yang · C. · Feng · M. · Wu · Y. — Marzo 3rd 2026 at 13:40
Introduction

Chronic obstructive pulmonary disease (COPD) affects approximately 480 million individuals globally and is projected to reach 600 million by 2050, representing a substantial burden on healthcare systems and patient quality of life. Pulmonary rehabilitation is a cornerstone intervention for COPD management, delivering clinically meaningful improvements in exercise capacity, health-related quality of life and dyspnoea. Despite strong guideline recommendations and established efficacy, only 2%–4% of eligible patients with COPD access traditional centre-based pulmonary rehabilitation due to geographical barriers, transportation difficulties, scheduling conflicts and limited healthcare resources. Digital health technologies offer promising alternatives to overcome these access barriers while potentially maintaining therapeutic benefits. Various digital delivery models have emerged, including video-based telerehabilitation, virtual reality platforms, mobile health applications and web-based programmes. However, their comparative effectiveness remains unclear, limiting evidence-based clinical decision making. This systematic review and network meta-analysis will aim to compare and rank the effectiveness and safety of different digital health delivery models for pulmonary rehabilitation in patients with COPD, providing evidence to inform optimal intervention selection in clinical practice.

Methods and analysis

We will conduct a systematic review and Bayesian network meta-analysis following Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Network Meta-Analyses guidelines. Comprehensive searches will be performed across five electronic databases (PubMed, Embase, Cochrane Central Register of Controlled Trials, Web of Science, CINAHL) from inception to January 2026, without language restrictions. Eligible studies will include randomised controlled trials comparing digital health delivery models for pulmonary rehabilitation in adults with COPD. Digital health interventions will be categorised into four distinct delivery models: video-based telerehabilitation, virtual reality rehabilitation, mobile health rehabilitation and web-based platform rehabilitation. Interventions combining multiple modalities will be categorised according to the predominant component based on intervention frequency, duration and primary therapeutic mechanism. Two independent reviewers will perform study selection, data extraction and risk of bias assessment using the Cochrane Risk of Bias 2 tool. The primary outcome will be change in 6 min walk distance. Key secondary outcomes will include disease-specific quality of life measures, dyspnoea severity, hospitalisation rates, exacerbation frequency, intervention adherence and adverse events. A Bayesian random-effects network meta-analysis will be conducted, calculating mean differences or ORs with 95% credible intervals. Treatment rankings will be estimated using surface under the cumulative ranking curve probabilities. Evidence certainty will be assessed using the Confidence in Network Meta-Analysis framework. Planned subgroup analyses will explore potential effect modifiers including disease severity, intervention duration, supervision mode and technological features.

Ethics and dissemination

As this systematic review will use data from previously published studies, formal ethical approval is not required. Findings will be disseminated through peer-reviewed publication, presentations at relevant scientific conferences and communication to healthcare providers, policymakers and patient advocacy organisations.

PROSPERO registration number

CRD420251268701.

☐ ☆ ✇ BMJ Open

Pragmatic, open-label, multicentre, randomised controlled trial to guide initial therapy for immune checkpoint inhibitor-induced inflammatory arthritis comparing standard of care (prednisolone) to adalimumab without glucocorticoids: REACT trial protocol

Por: Fisher · B. A. · Rowe · A. · Hodson · C. · Wilkhu · M. · Williams · E. · Turner · E. · Allard · A. · Blake · T. · Bombardieri · M. · Cope · A. P. · Dubey · S. · Mankia · K. · Malley · T. · Moore · O. · Payne · M. · Plummer · R. · Tilby · M. · Tillett · T. · Wong · E. · Wu · Y. · Filer · A. · Pra — Marzo 3rd 2026 at 13:40
Introduction

Immune checkpoint inhibitors (ICIs) have revolutionised cancer treatment through targeted disruption of the physiological pathways that maintain tissue tolerance, but which are co-opted by cancers to evade immunosurveillance. Thus, the resultant T-cell activity often causes immune-related adverse events including immune checkpoint inhibitor-induced inflammatory arthritis (ICI-IA). ICI-IA results in functional impairment that frequently persists, even after ICI discontinuation, with substantial quality-of-life impacts for cancer survivors.

A high-quality body of evidence to guide ICI-IA management remains an unmet need. Pharmacological treatment may be prolonged, typically begins with non-specific immunosuppression, including systemic steroids, and is usually only rationalised to more targeted therapy in resistant cases. Moreover, retrospective data suggest the high dose glucocorticoids sometimes used in new-onset ICI-IA may be associated with worse cancer outcomes.

Tumour necrosis factor (TNF) inhibition strategies are well established with excellent efficacy and safety profiles in ‘spontaneous’ inflammatory arthritides including rheumatoid and psoriatic arthritis. Mechanistic evidence from ex vivo and murine studies also supports the utility of anti-TNF therapy for steroid-refractory cases of ICI-IA. Although good clinical responses have been reported in this setting, the REACT trial (REmission induction of Arthritis caused by Cancer ImmunoTherapy) aims to provide randomised and robust clinical evidence for deploying targeted therapy earlier in ICI-IA management. It will test whether up-front anti-TNF therapy can more effectively and quickly control symptoms, reduce glucocorticoid exposure, prevent early ICI discontinuation and increase the frequency of drug-free ICI-IA remission.

Methods and analysis

REACT is a prospective, multicentre, open-label, superiority, two-arm, randomised controlled clinical trial to guide initial therapy for patients with ICI-IA. The trial will compare the current standard of care (initial prednisolone; Arm A) with the anti-TNF drug, adalimumab without glucocorticoids (Arm B).

The primary outcome is glucocorticoid-free arthritis remission rate at 24 weeks where remission is defined as: (i) No use of systemic or intra-articular glucocorticoids (except when used for adrenal insufficiency) within 4 weeks prior to assessment at 24 weeks; and (ii) absence of synovitis on clinical examination.

Ethics and dissemination

The protocol was approved by East Midlands—Leicester South Research Ethics Committee on 31-Oct-2024 (Ref: 24/EM/0202). Participants are required to provide written informed consent. The results of this trial will be disseminated through national and international presentations and peer-reviewed publications.

Trial registration number

ISRCTN18217497.

☐ ☆ ✇ BMJ Open

Hepatitis B virus infection and its determinants among pregnant women in Ethiopia: protocol for umbrella review of systematic review and meta-analysis 2025

Por: Bekele · M. · Oche · W. O. · Geltore · T. E. · Sileshi · E. · Hadaro · T. S. · Alano · B. A. · Abera · W. — Marzo 3rd 2026 at 13:40
Introduction

Among the five hepatitis viruses, the hepatitis B virus (HBV) is a major cause of serious acute and chronic liver infections worldwide. The major public health impact of HBV infection arises from chronic liver disease, including cirrhosis and hepatocellular carcinoma, which predominantly affects young and middle-aged adults of both sexes. Therefore, preventive interventions focusing on mothers and infants are critical due to vertical and early childhood transmission dynamics.

HBV prevalence largely varies among pregnant women in Ethiopia because of multiple interrelated factors. This umbrella review will consolidate all existing systematic reviews and create a more reliable picture of HBV infection and its determinants among pregnant women in Ethiopia.

Methods and analysis

This umbrella review will be conducted according to Preferred Reporting Items for Systematic reviews and Meta-Analyses reporting standards. The review will focus on identifying and integrating evidence from eligible systematic reviews and meta-analyses, with methodological quality appraised using the MeaSurement Tool to Assess systematic Reviews instrument. A comprehensive literature search strategy will be developed using relevant Medical Subject Headings alongside free-text keywords. Electronic searches will be conducted in PubMed/MEDLINE, African Journals Online, Web of Science, Scopus and Google Scholar. Statistical heterogeneity among the included reviews will be quantified using the I² statistic. Data management and meta-analytic procedures will be performed using STATA version 17, and effect estimates will be presented with corresponding 95% CIs to determine statistical precision.

Ethics and dissemination

This review uses only published or publicly available data, so ethics approval is not required. Findings will be disseminated via peer-reviewed publications, conference presentations and shared with policymakers, healthcare partners, clinicians and patients to inform policy, enhance education and guide future research.

PROSPERO registration number

PROSPERO (CRD420251118982).

☐ ☆ ✇ BMJ Open

Mapping the evidence on dietary acculturation post-migration among Indian immigrants in Australia, Canada, New Zealand and the UK: a scoping review protocol

Por: Bachani Singh · S. · George · M. S. · Upton · P. · Knight-Agarwal · C. R. — Marzo 3rd 2026 at 13:40
Introduction

Indian immigrants experience significant dietary acculturation post-migration, shifting from traditional diets to more westernised eating patterns influenced by socioeconomic and environmental factors. This transition, often marked by increased processed food consumption and reduced intake of traditional staples, contributes to elevated risks of obesity and type 2 diabetes. Despite the growing Indian diaspora in Australia, Canada, New Zealand and the UK, the evidence on their dietary acculturation remains limited.

Methods and analysis

This review will adopt the Joanna Briggs Institute (JBI) methodology for scoping reviews. A three-step search strategy will be applied across databases including MEDLINE (via PubMed), CINAHL, Scopus and Web of Science. Google Scholar will be used as a supplementary search tool to identify additional relevant studies. The search will include peer-reviewed studies and grey literature published in English between 1 January 2000 and 22 May 2025. First-generation Indian immigrants of all ages will be included, while second-generation immigrants, refugee populations and studies linked to non-communicable disease interventions will be excluded. Screening will be conducted in Covidence by two independent reviewers, with discrepancies resolved by a third reviewer. Data will be extracted using a standard JBI tool, charted in tabular form, and synthesised narratively and thematically.

Ethics and dissemination

As this review will use published and publicly available data, formal ethics approval is not required. Findings will be disseminated through peer-reviewed publication, conference presentations and community engagement.

☐ ☆ ✇ BMJ Open

From mother to child: a protocol paper on the longitudinal effects of a perinatal intervention on maternal self-efficacy and emotion regulation and child outcomes

Por: Montreuil · T. · Skinner · J. · Humez · L. · Gratton · C. · Herba · C. M. · Cote · S. M. — Marzo 3rd 2026 at 13:40
Introduction

Parental psychological challenges and poor well-being are key factors in shaping both the quality of parent-child interactions and child development. Specifically, maternal psychological distress is a central determinant of child development. Elevated levels of distress in mothers are associated with poorer child cognitive, behavioural and social-emotional outcomes, with effects persisting into adolescence and adulthood. While this highlights the critical importance of early prevention and intervention efforts to support parents, postpartum mental healthcare remains limited, despite ongoing and evident needs.

Methods and analysis

This protocol outlines a 2-year longitudinal follow-up study investigating the impact of a secondary perinatal programme (ie, Toi, Moi, Bébé), completed by mothers during pregnancy, and its impact on children’s cognitive and social-emotional functioning at 24 and 48 months. Further, the study aims to explore whether maternal self-efficacy and emotion regulation may serve as potential mediators or moderators of the relationship between programme participation and child development outcomes. The research aims to leverage the Toi, Moi, Bébé programme, by recruiting mother-child dyads (n=250) in which the mothers participated in the programme during pregnancy. Mothers were randomly assigned to complete the parenting well-being intervention either independently or with added telephone support. Participants who consent will be invited to take part in a two-wave follow-up at 24 months (T1) and 48 months postpartum (T2). At both time points, mothers will complete demographic questionnaires and standardised measures assessing maternal well-being (Generalised Anxiety Disorder-7, Edinburgh Postnatal Depression Scale and Perceived Stress Scale), child cognitive functioning (Ages and Stages Questionnaire-3 and MacArthur-Bates Communicative Development Inventory), child social-emotional functioning (Ages and Stages Questionnaire, Social Emotional—second Edition-2 and Child Behaviour Checklist for Ages 1.5–5), maternal emotion regulation (Cognitive Emotion Regulation Questionnaire) and maternal self-efficacy (Parental Cognitions and Conduct Towards the Infant Scale & Me as a Parent Scale). Parents’ perceptions of their parenting experience will be measured using the Parental Reflective Functioning Questionnaire. Mother-child interaction, parenting quality and cognitive stimulation in the home environment will be measured using a brief virtual interview (StimQ2-Toddler) and a naturalistic observation assessment (Parenting Interactions with Children: Checklist of Observations Linked to Outcomes). Using RStudio, linear mixed models will be used to assess the impact of the intervention (online intervention only vs only with telephone support) on child cognitive and social-emotional development at T1 and T2. In parallel, separate models will be conducted to examine associations between maternal emotion regulation and self-efficacy on the child development outcomes at the same timepoints. Exploratory analyses will be conducted to examine potential moderating effects of child sex and group assignment on the associations between maternal emotion regulation and self-efficacy and child developmental (cognitive and socioemotional) outcomes, using causal inference models.

Ethics and dissemination

The current study has been registered, reviewed and approved (MP-37-2025-10894) by the Research Institute of the McGill University Health Centre Research Ethics Board. Findings from this research will be disseminated through peer-reviewed open access publications, and presentations at national and international conferences.

Trial registration number

NCT05110456.

☐ ☆ ✇ BMJ Open

Associations between indices of body composition and metabolic status in normal-weight adults: a cross-sectional study of the Tehran Lipid and Glucose Study

Por: Maleki · S. · Hosseinpanah · F. · Mahdavi · M. · Momenan · A. A. · Ebadi · S. A. · Rahmani · F. · Azizi · F. · Valizadeh · M. — Marzo 3rd 2026 at 13:40
Objective

To investigate associations between body composition indices and metabolic status among normal-weight adults.

Design

Cross-sectional study using data from the Tehran Lipid and Glucose Study (phaseVII: 2019–2021).

Setting

Primary care and community health services in an urban Tehran population.

Participants

1298 adults (40.5% men, 59.5% women), aged 18–80years, body mass index (BMI) 18.5–24.9 kg/m². Exclusions: known diabetes, cardiovascular disease, kidney failure, malignancy, pregnancy or lactation, diuretic or glucocorticoid use. Participants were classified as metabolically healthy normal weight (MHNW) or unhealthy (MUHNW).

Primary and secondary outcome measures

The primary outcome was the association between body composition and anthropometric indices with metabolic status. The secondary outcome was identification of the strongest predictors of MUHNW. Body composition was assessed by bioelectrical impedance analysis to obtain fat mass (FM), body fat percentage (BFP), skeletal muscle mass percentage (SMM%), fat mass index (FMI), fat-free mass index, skeletal muscle indices and the fat-to-muscle mass ratio (FMR). Anthropometric measures included waist circumference (WC) and waist-to-hip ratio (WHR). Associations were examined using logistic regression adjusted for age, smoking and physical activity.

Results

Mean age: 37.5±12.8 y; MUHNW participants were older than MHNW (44.5±13.2 vs 35.8±12.1 years, p

Conclusions

BMI, WC, WHR and body fat indices were positively associated with metabolically unhealthy status among normal-weight adults of both sexes. WHR was the strongest predictor, highlighting its value for identifying at-risk individuals where advanced body composition tools are unavailable.

☐ ☆ ✇ BMJ Open

Effectiveness and cost-effectiveness of a 9 week multi-component cycling programme versus an existing single cycling training session: protocol for the Cycle Nation Communities randomised controlled trial

Por: Lawlor · E. R. · Gabler Trisotti · M. F. · McIntosh · E. · McConnachie · A. · Gill · J. M. R. · Gray · C. M. — Marzo 3rd 2026 at 13:40
Introduction

Cycling can be beneficial for health, well-being and the environment; however, cycling participation in the UK remains low. Effective and cost-effective strategies are needed to support people in the community to increase cycling. The Cycle Nation Communities randomised controlled trial (RCT) will evaluate whether a 9 week multi-component cycling programme (Cycle Nation) is more effective and cost-effective than an existing national cycle training session on cycling participation, transport use and health and well-being.

Methods and analysis

This pragmatic, single-blinded, two-arm RCT will recruit ≥268 adults who cycle infrequently. Participants will be randomised to the 9 week multi-component individual/social-level group-based Cycle Nation programme or an existing national standard single group-based cycle training session. Both arms will be delivered by community-based cycling organisations in Glasgow. Participants will complete self-reported measurements at baseline, 12 weeks and 12 months. The primary outcome is the proportion of participants cycling at least weekly at 12 months. Secondary outcomes include proportion of participants cycling at least weekly at 12 weeks; change in weekly number of rides and minutes of cycling and use of private car, taxi, public transport and walking at 12 weeks and 12 months; change in motivation, perceptions of cycling safety, confidence to cycle, self-esteem, vitality, health-related quality of life and perceived general physical health at 12 weeks and 12 months. A within-trial economic evaluation from a National Health Service/personal social service and a broader societal perspective will be undertaken. Pending within-trial results, a long-term model may be developed. An embedded process evaluation will use participant and facilitator interviews, participant acceptability questionnaires, facilitator delivery proforma and session observations.

Ethics and dissemination

Ethical approval has been obtained from the University of Glasgow Medical, Veterinary and Life Sciences Ethics Committee (11 April 25). Findings will be published in peer-reviewed journals and communicated to stakeholders and the public.

Trial registration number

NCT07005674.

☐ ☆ ✇ BMJ Open

Prevalence of potentially inappropriate medication prescribing, inappropriate medication use, prescription omission and drug interactions among older adults in Ethiopia: a systematic review and meta-analysis

Por: Yazie · T. S. · Alemu · M. A. · Zewdu · W. S. · Asmare Emiru · Z. · Tarekegn · G. Y. · Meharie · B. G. · Belete · A. M. · Debasu Addisu · Z. — Marzo 3rd 2026 at 13:40
Objective

To determine the prevalence of potentially inappropriate prescribing (PIP), potentially inappropriate medication (PIM), potential prescription omission (PPO), potentially harmful drug–drug interactions (PDDI) and identify associated factors among older Ethiopians.

Design

Systematic review and meta-analysis

Data source

We searched PubMed, HINARI, Scopus and Web of Science databases to identify eligible studies published up to 31 October 2025.

Study selection

Observational studies reported the prevalence of PIP, PIM, PPO and PDDI among older adults from any healthcare settings were screened.

Data extraction and synthesis

Two independent reviewers selected studies, extracted data and assessed the risk of bias. The quality and risk of bias of the studies were assessed using the Newcastle-Ottawa scale and Hoy risk of bias tool, respectively, while the certainty of evidence of outcomes was assessed using Grading of Recommendations, Assessment, Development and Evaluation based on Cochrane recommendations. We used a random-effects model for analyses to estimate the pooled prevalence and associated factors. All data analyses were done using Stata V.17 software.

Main outcomes and measures

The national prevalence of PIP, PIM, PPO and PDDI was estimated as main outcomes. Variations were estimated based on regions, age groups, outcome evaluation tool, disease type and healthcare setting.

Results

The review included 25 studies (n=5662 participants) for PIP or PIM, 14 studies (n=2706 participants) for PDDI and 6 studies (n=1342 participants) for PPO. The pooled prevalence estimate was 41% (95% CI 33% to 48%), I2=96.87% for PIP, 37% (95% CI 31% to 44%), I2=96.33% for PIM, 55% (95% CI 36% to 73%), I2=99.00% for PDDI and 14% (95% CI 6% to 24%), I2=95.07% for PPO. The majority of the studies have very good quality (very good=13, good=1, satisfactory=11 for PIP and PIM; very good=11, satisfactory=3 for PDDI; very good=6 for PPO) and low risk of bias (low risk=18, moderate risk=7 for PIP and PIM; low risk=12, moderate risk=2 for PDDI and low risk=6 for PPO), while all studies for each outcome have low certainty of evidence. Subgroup analyses revealed significant regional and contextual variations. Polypharmacy was significantly associated with PIP (OR=3.72, 95% CI 2.53 to 5.46, p2=69.56%), PIM (OR=4.20, 95% CI 2.91 to 6.06, p2=57.83%) and PDDI (OR=4.51, 95% CI 3.05 to 6.69, p2=0.00%), while hypertension (OR=2.46, 95% CI 1.38 to 4.36, p2=0.00%) was associated with PIP.

Conclusions and relevance

This review found a high prevalence of PIP, PIM, PDDI and PPO among older adults in Ethiopia, with notable heterogeneity across regions. Polypharmacy was associated with PIP, PIM and PDDI, while hypertension showed association with PIP. Despite generally good study quality, the certainty of evidence was low for the included studies due to the cross-sectional design nature, with high heterogeneity. Therefore, these findings should be interpreted cautiously. This study indicates a high burden of inappropriate medication prescribing and its associated factors, underscoring the importance of further robust studies to clarify prescribing practices and associated factors.

PROSPERO registration number

CRD42024556744.

☐ ☆ ✇ BMJ Open

Feasibility of the ICF CoreSets for Autism Strengths and Needs Assessment in NHS diagnostic services in England: protocol for a randomised pilot trial

Por: Day · M. · Scargill · K. · Poole · D. · Kellar · I. · Young · T. A. · Bölte · S. · Clarke · S. · Lodge · K.-M. · Woods · A. · Freeth · M. — Marzo 3rd 2026 at 13:40
Introduction

There are approximately 700 000 autistic people in the UK, and autism is increasingly being diagnosed in adulthood. Diagnosis on its own does not provide adequate information to plan post-diagnostic support for autistic people, and clinicians often plan support without the use of validated standardised tools which may exacerbate inequities in care. This study will evaluate a novel strengths and needs assessment, based on the WHO’s International Classification of Functioning, Disability and Health CoreSet for Autism, for use in adult diagnostic services immediately on receipt of an autism diagnosis. Potential issues, including the length of the assessment, timing of delivery and selection bias, will be explored as part of the trial process evaluation.

Methods and analysis

A two-arm, multisite, randomised pilot trial design will be used to evaluate the ICF CoreSets for Autism Strengths and Needs Assessment in three diagnostic services in England. A total of 72 newly diagnosed autistic adults will be recruited across the three sites over a 6-month period and randomised into an assessment group (strengths and needs assessment plus standard care) and a treatment as usual group (standard care only). The assessment group will receive a summary report of their strengths and needs on completion of the assessment. Both groups will complete measures of mental health and quality of life at baseline and 3 months follow-up (Patient Health Questionnaire-9, Generalised Anxiety Disorder questionnaire-7, Recovering Quality of Life questionnaire-10, EuroQoL-5D). Acceptability and feasibility will be measured for the strengths and needs assessment and for trial procedures using standardised measures, progression criteria and qualitative data from clinician focus groups and interviews with a subsample of autistic participants. The study design and procedures are being co-produced with an autistic advisor/patient and public involvement lead and with a steering group of autistic adults.

Ethics and dissemination

This study was reviewed by the East Midlands—Nottingham 2 Research Ethics Committee and was given Health Research Authority approval on 18 March 2025 (REC reference:25/EM/0041). The results will be disseminated via reports to the funder (NIHR), a peer-reviewed journal paper and academic conferences. We will email a summary report of findings to study participants and will invite participants to an information dissemination event at the end of the study. Links to reports and a lay summary will be provided on the research group’s website: https://sharl.sites.sheffield.ac.uk/home

Trial registration number

ISRCTN10283350.

☐ ☆ ✇ BMJ Open

Cross-sectional observational study evaluating social brain health in HIV using a research domain criteria-based approach: a protocol

Por: Vance · D. E. · Brennan-Ing · M. · Lambert · C. C. · Hellemann · G. · Zeng · X. · Lee · J. — Marzo 3rd 2026 at 13:40
Introduction

Some people with HIV (PWH) experience brain changes that affect neurocognition, but little is known about how HIV impacts social cognition or related brain regions. Social cognition, the ability to perceive, understand and respond to social information, is important for maintaining relationships and quality of life. This article provides the protocol for the first comprehensive study examining social brain function in PWH and people without HIV (PWoH). With three aims, this study will: (1) examine neural circuits related to social cognition; (2) examine social cognitive performance across two social cognitive domains and (3) examine the role of social cognition in everyday social functioning.

Methods and analysis

Referred to as Social Brain Health Study in HIV Study, this cross-sectional study will enrol 105 PWH and 105 demographically matched PWoH aged 18–65 years. The study administers a comprehensive assessment battery across two visits within a 2-week period. Visit 1 includes behavioural measures of social cognition (Perceiving Social Cues and Understanding Others), neurocognition and social functioning (social network size and loneliness). Visit 2 involves functional MRI procedures with three social cognitive tasks designed to activate key brain regions (ie, fusiform face area, superior temporal gyrus, temporo-parietal junction, dorsal medial prefrontal cortex).

Ethics and dissemination

This study was funded by the National Institute of Mental Health (MH139613) and approved by the Institutional Review Board of the University of Alabama at Birmingham (IRB-300013394). Data collection is ongoing. The first results are expected to be submitted for publication in 2030. Findings of this study will be published in peer-reviewed journals and presented at local, national and international conferences as well as patient organisations such as AIDS service organisations and community talks.

☐ ☆ ✇ BMJ Open

Effect of prehabilitation before total knee replacement on postoperative patient-reported joint awareness, enablement and knee function: protocol for the PROTEKT randomised controlled trial

Por: Ljung · M. · Gustafsson · K. · Kvist · J. — Marzo 3rd 2026 at 13:40
Introduction

Knee osteoarthritis (OA) causes pain, reduced function and disability and may require total knee replacement (TKR). Although TKR is effective, up to 20% of patients remain dissatisfied, partly due to poor preoperative function and unrealistic expectations. Long waiting times for surgery may worsen patients’ function, yet preoperative physiotherapy is rarely offered. Prehabilitation—exercise and education before surgery—could improve postoperative recovery, but current evidence is limited. This trial investigates whether adding prehabilitation to standard care before TKR improves postoperative patient-reported joint awareness, enablement and knee function.

Methods and analysis

This multicentre, randomised controlled parallel-group trial is planned to be conducted within two specialised orthopaedic outpatient rehabilitation units in the southeast healthcare region of Sweden. Eligible patients (40–85 years, awaiting unilateral TKR) are randomised 1:1, stratified by age (≤67, >67 years), to either 8 weeks of prehabilitation—comprising two times per week supervised exercise therapy (strength, range of motion and balance) and education—in addition to standard care, or to standard care alone. Standard care consists of self-care, a single standardised preoperative education session and standardised postoperative rehabilitation. Assessments are conducted at baseline, post-intervention, 1 week pre-surgery and 6, 12 and 52 weeks post-surgery. A total of 110 patients will be recruited to the trial. Primary outcomes are joint awareness (Forgotten Joint Score-12) and patient enablement (modified Patient Enablement Instrument-2). Secondary outcomes are patient satisfaction (5-category Likert scale), the Knee injury and Osteoarthritis Outcome Score, the EuroQol 5 Dimension 3 Level questionnaire, the International Physical Activity Questionnaire—short form, objective function and accelerometer-based physical activity. Analyses will follow intention-to-treat and per-protocol principles. Between-group and within-group differences will be tested using t-tests or non-parametric equivalents, and linear mixed models or generalised linear models. Multiple linear regression and logistic regression will be used to analyse predictor variables for the primary outcomes. Sensitivity analyses will be performed to quantify the magnitude of missing data from patients lost to follow-up.

Ethics and dissemination

The trial has received ethical approval from the Swedish Ethical Review Authority (reg. no.2023-05120-01) and complies with the Declaration of Helsinki. Signed informed consent is collected for all patients before entering the trial. Results will be submitted for publication in a peer-reviewed journal and presented at international/national conferences. The findings may improve future clinical guidelines and care pathways for patients undergoing TKR.

Trial registration number

NCT06290336.

☐ ☆ ✇ BMJ Open

Understanding integrated mental healthcare for people experiencing forced migration: a realist review protocol

Por: Clark · N. · Argüelles Bullon · A. · Huq · M. · Mukumbang · F. C. — Marzo 3rd 2026 at 13:40
Introduction

Forced migrants (i.e., asylum seekers and refugees) experience greater mental health disparities and inequities in care. Mental health services and systems lack clear policy on integrated mental healthcare. Understanding the causal mechanisms of integrated mental health for migrants can promote a resilient and adaptive health and social care system. However, to achieve a functional mental health service integration, there is a need to understand how and why mental health system integration works and under what health systems conditions. The purpose of this realist review protocol will be to outline a process for refining an initial programme theory (IPT), developed through deliberative dialogues with key interest groups in British Columbia, Canada, and to test the IPT against the global evidence base.

Methods and analysis

A realist review is an interpretive methodological approach to synthesising the literature based on the realist philosophy of science. Realist reviews are pragmatic approaches to theory development because they involve the participation of real-world actors or people who work within complex systems. Realist reviews are particularly useful for synthesising complex knowledge. We plan to conduct a seven-step review process, with iteration between each step. Steps 1–3 have already been completed in our previous work and included the development of an IPT, which will be refined systematically by exploring the global literature and consulting with an international advisory group. These will be used iteratively to identify, test and refine the programme theory. The quality of included literature will be appraised using the relevance, richness and rigour criteria and the realist quality appraisal tool, TAPUPASM (transparency, accessibility, propriety, utility, purposiveness, accuracy, specificity and modified objectivity). Steps 4–7 will include data extraction and realist analysis through retroductive theorising using the ICAMO (intervention, context, actor, mechanism and outcome) heuristic to help distinguish actors and resources from contexts, mechanisms and outcomes.

Ethics and dissemination

Ethics approval for the deliberative dialogue interviews that inform this realist review and IPT were obtained by the University of British Columbia (ref: REB Number: H22-03195). Study recruitment occurred between 21 November 2023 and 16 January 2024. All participants provided informed consent to take part in deliberative dialogues and to have their interviews audio recorded and transcribed for the purpose of this research. We will disseminate results of the review through academic papers, conference presentations and through iterative interest group workshops and discussions.

PROSPERO registration number

CRD42024580083.

☐ ☆ ✇ BMJ Open

Household determinants of healthcare utilisation in three informal settlements in Freetown, Sierra Leone: a cross-sectional survey

Por: Sesay · S. · Sesay · I. J. · Tengbe · S. M. · Wurie · H. · Fullah · S. · Vangahun · D. · Gandi · I. · Teixeira de Siqueira Filha · N. · Lakshman · R. W. D. · Conteh · A. · Saidu · S. · Koroma · B. · Mansaray · B. · Elsey · H. · Whittaker · L. · Dean · L. · Wiltgen Georgi · N. · Nganda · M — Marzo 3rd 2026 at 13:40
Objective

Healthcare utilisation (HU) is key to improving the health of residents in urban informal settlements. This study aimed to explore household-level factors influencing HU among informal settlement households in Freetown, Sierra Leone.

Design

Cross-sectional survey.

Setting

Three informal settlements (Cockle Bay, Dwarzark and Moyiba) in Freetown, Sierra Leone.

Participants

Primary data from 4871 households were collected during the Health and Wellbeing survey conducted between April and May 2023, targeting households with adults aged 18 years and older.

Primary outcome measures

The primary outcomes were households HU both within and outside informal settlements. Household-level predisposing and enabling explanatory variables were derived from Andersen’s Behavioural Model of HU.

Results

Disability in households increases HU within settlements (especially in Dwarzark, 13% and Moyiba, 10%) but is less likely outside. Households engaged in income-generating activities are more likely to seek healthcare within settlements, but 12% less likely outside in Cockle Bay and Dwarzark. Food insecurity decreases HU within Dwarzark (9%) and increases HU outside by 174% in Moyiba. Longer water fetching times and water shortages were associated with higher HU (between 6% and 16%) within settlements, especially in Cockle Bay and Dwarzark. Clean water sources (eg, piped dwelling, bowser, surface, bottled) were consistently associated with higher HU both within and outside settlements. Shared sanitation facilities (such as shared toilets) were positively associated with HU both within and outside settlements, particularly in Dwarzark and Moyiba. Households with income from fishing, informal salaried work and bike riding showed higher HU both within and outside settlements, especially in Dwarzark and Moyiba.

Conclusions

We identified strong settlement-specific patterns of household-level factors that influence HU both within and outside Freetown’s informal settlements. These findings provide a foundation for developing targeted policies such as strengthening local services, addressing affordability and accessibility barriers and supporting vulnerable occupation groups.

☐ ☆ ✇ BMJ Open

Determinants of barriers to accessing healthcare services among married women in Somalia: a multilevel analysis of nationwide survey data

Por: Ali · A. S. · Hassan · Y. S. A. · Ahmed · M. M. · Omar · M. A. — Marzo 3rd 2026 at 13:40
Objectives

To identify the individual and community-level factors associated with barriers to accessing healthcare services among currently married women in Somalia.

Design

A cross-sectional analysis using data from the 2020 Somalia Demographic and Health Survey.

Setting

Somalia.

Participants

A nationally representative sample of 30 311 currently married women aged 15–49 years with complete data on outcome and explanatory variables.

Primary outcome measures

The primary outcome was ‘reporting at least one barrier to accessing healthcare’, a composite binary variable based on four specific problems: obtaining permission to go for treatment, getting money for treatment, distance to the health facility and not wanting to go alone.

Results

A substantial majority (77.06%) of married women reported experiencing at least one barrier to accessing healthcare. Financial cost was the most common barrier (69.91%), followed by distance to health facilities (65.95%), reluctance to go alone (49.64%) and the requirement for permission (46.03%). Multilevel analysis confirmed that higher household wealth was strongly protective (richest vs poorest: adjusted OR (aOR)=0.27, 95% CI 0.24 to 0.32). Paradoxically, factors typically considered protective were associated with increased barriers: women with secondary education (aOR=1.19, 95% CI 1.00 to 1.41) and those with educated husbands (aOR=1.23, 95% CI 1.14 to 1.33) reported more obstacles. Similarly, urban residents faced higher odds of barriers than their nomadic counterparts (aOR=1.40, 95% CI 1.27 to 1.55). Significant regional disparities were evident, with community-level context explaining 26.30% of the total variance in reporting barriers.

Conclusion

Access to healthcare for married women in Somalia is predominantly hindered by economic, educational and community-level constraints. Targeted interventions addressing socioeconomic disparities, infrastructural deficits and specific community contexts are essential to alleviate these barriers.

☐ ☆ ✇ BMJ Open

Population-based study of pharmacogenetics and pharmacokinetics in Southern African patients with multidrug-resistant tuberculosis (PoPG): a protocol for the Namibian cohort

Por: Boois · L. · Ekandjo · H. · Shavuka · O. · Nepolo · E. · Ndong Sima · C. A. · Oelofse · C. · Uren · C. · Petersen · D. C. · Möller · M. · Wijk · M. · Kellermann · T. · Decloedt · E. · McIlleron · H. · Denti · P. · Claassens · M. M. — Marzo 3rd 2026 at 13:40
Background

Multidrug-resistant tuberculosis (MDR-TB) is an urgent public health challenge in Namibia, with profound socioeconomic consequences. The high burden of both tuberculosis and HIV complicates treatment and underscores the need for optimised drug therapies. Precision medicine, which leverages patient-specific genetic and molecular information, offers promise for improving MDR-TB outcomes. However, its effective application relies on population-specific data, particularly understanding how individuals metabolise tuberculosis drugs and how genetic diversity drives variability in treatment response. Currently, no pharmacokinetic (PK) or pharmacogenetic (PG) data on TB treatment exist for Namibian populations. This gap is particularly concerning, given the country’s genetic diversity, environmental factors and comorbidities that may uniquely influence drug metabolism. This study aims to generate PK and PG data to inform dose optimisation and support personalised treatment strategies for MDR-TB in Namibia. The findings will contribute to improved patient care and inform health system strengthening based on locally relevant evidence.

Methods

This cross-sectional study will consist of 100 Namibian participants with matched human DNA and PK data of MDR-TB cases receiving isoniazid, clofazimine, bedaquiline and the fluoroquinolones (levofloxacin or moxifloxacin). PK sampling will be divided as follows: 30 individuals will undergo intensive PK sampling, while the remaining (n=70) will undergo sparse PK sampling. DNA will be extracted at Stellenbosch University (SU), and samples will be genotyped using the H3Africa microarray. Sequences will be aligned to the human reference genome, hg38 (GRCh38p13), using the freely available Burrows-Wheeler Aligner. A subset of the samples (n=20–30) will undergo whole genome sequencing (WGS) to verify imputation results and identify novel genetic variants potentially affecting PK in this population.

Data analysis

Quality control and variant call format file generation will be performed using the Genome Analysis Toolkit best practices (V.3.5). Intensive and sparse PK data will be pooled for the development of a population PK (popPK) model using a non-linear mixed-effects modelling approach. The popPK model will characterise the relationship between TB drug dose and exposure, including quantifying covariates, including genetic variation, explaining PK variability, providing a foundation for dose optimisation and personalised treatment strategies.

Ethics and dissemination

Ethics approval was obtained from the University of Namibia Human Research Ethics Committee for Health (Ref. SOM18/2024), the Ministry of Health and Social Services (Ref. 22/4/2/3), the SU Health Research Ethics Committee (Ref. N21/11/136) and the University of Cape Town Human Research Ethics Committee (Ref. 500/2022).

☐ ☆ ✇ BMJ Open

Assessment of health-related quality of life, cognitive, physical and psychological impairments in critically ill adults after status epilepticus (POSEIDON 2): protocol for a multicentre longitudinal study

Por: Legriel · S. · Bernard · C. · Sboui · G. · Sigaud · F. · Lascarrou · J.-B. · Mayenco-Cardenal · N. · Chelly · J. · Bruel · C. · Mongardon · N. · Marzouk · M. · Quenot · J.-P. · Hugues · R. · Schnell · D. · Beuret · P. · Bailly · P. · Lesieur · O. · Argaud · L. · Chambon · R. · Jacq · G. — Marzo 3rd 2026 at 13:40
Introduction

Status epilepticus (SE) in adults is a serious neurological emergency that can lead to high morbidity and mortality rates. Although functional outcomes are often assessed using general scoring systems, limited data on health-related quality of life (HRQoL) in patients admitted to intensive care units (ICUs) are still limited. Furthermore, comprehensive evaluations of patient-reported physical, cognitive, mental health and psychological outcomes are lacking in this population. POSEIDON 2 aims to assess HRQoL and cognitive, physical and psychological impairments at 3 and 12 months after ICU discharge following SE and quantify caregiver burden.

Methods and analysis

POSEIDON 2 is a prospective, multicentre, longitudinal study conducted in 19 French ICUs. The study combines data from the SE ICTAL Registry with data from patients who survived admission to the ICU for SE, who will be recruited for the study. The study also includes patient-reported outcome (PRO) data collected 3 (M3) and 12 (M12) months after discharge from the ICU using validated instruments. The Zarit scale will be used to measure the burden on caregivers at M3 and M12. The primary endpoint is the prevalence of overall HRQOL impairment at M3 and M12, as defined by dichotomous scores on the physical and mental components of the 36-Item Short Form Health Survey compared with those of the general population. Secondary endpoints include domain-specific impairments, such as cognitive function, dependence, mental health and patient experiences. The sample size has been calculated based on an estimated prevalence of 75% for HRQoL impairment, with a planned sample size of 140 patients.

Ethics and dissemination

The POSEIDON 2 study protocol received ethical approval from the ethics committee ‘Comité de Protection des Personnes Ouest VI’ on 5 October 2023 (#2023-A01223-42). The study is conducted in accordance with the Declaration of Helsinki, Good Clinical Practice and the regulatory requirements of France. Written informed consent is obtained from participants, who are able to decline participation or withdraw from the study at any time. Findings will be disseminated through publication in peer-reviewed journals and presentations at scientific conferences.

Trial registration number

NCT06100978.

☐ ☆ ✇ BMJ Open

Common mental health outcomes among children in conflict with the law in Africa: a systematic review protocol

Por: Maotoana · M. · Phalane · K. · Ndlovu · S. M. · Rapau · M. · Quarshie · E. N.-B. · Ntho · T. A. · Sepadi · M. D. · Oppong Asante · K. · Sodi · T. · Themane · M. J. — Marzo 2nd 2026 at 13:30
Introduction

Common mental health outcomes among children in conflict with the law in correctional facilities in Africa are an under-researched area with significant public health implications. This review will synthesise available and accessible evidence on the prevalence and associated factors of common mental health outcomes among children in conflict with the law in Africa.

Methods and analysis

Comprehensive electronic searches will date from 01 January 2015 to 31 December 2025 and will be conducted in PubMed, Sabinet, Scopus, EBSCOhost, Web of Science and PsycINFO. Articles will be screened using defined inclusion and exclusion criteria and assessed for eligibility by three independent reviewers. Discrepancies will be reviewed by a ninth reviewer. The selection process of included articles will be reported by using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses will be used. The Mixed Methods Appraisal Tool will assess study quality, and data will be synthesised using meta-analysis or a narrative synthesis approach, depending on heterogeneity levels.

Ethics and dissemination

This study will not require ethical approval from an institutional review board, as it does not entail the direct collection of data from children in conflict with the law, nor does it pose any risk to their privacy. Once finalised, the full review report will be submitted for publication in a peer-reviewed journal. The key findings will also be shared at both local and international conferences, highlighting common mental health outcomes among children in conflict with the law.

PROSPERO registration number

CRD420251011484.

☐ ☆ ✇ BMJ Open

Hospitalisations and deaths due to ambulatory care sensitive conditions among adults with and without intellectual disabilities in Scotland: a cohort study

Por: Sosenko · F. · Cairns · D. · Jani · B. · Ward · L. M. · Truesdale · M. · Hughes-McCormack · L. · Henderson · A. · Melville · C. — Marzo 2nd 2026 at 13:30
Objectives

To explore how well the primary care system in Scotland works for adults with intellectual disabilities (ID), using the rate of unplanned hospital admissions for ambulatory care sensitive conditions (ACSC) as a proxy indicator. As part of this, to investigate those rates and rate ratios among adults with ID and without ID, adjusting for the prevalence of a given ACSC in each population. The secondary aim was to explore deaths due to ACSC among the ID and no-ID populations.

Design

A population-based retrospective cohort data linkage study of adult respondents to Scotland’s 2011 Census. Self-reported or proxy-reported ID status from the Census was linked to hospital admissions data and deaths data. The cohort was followed until the end of 2019. The prevalence of ACSCs in each population was calculated from aggregate-level data published by the National Health Service, as it was not possible to use the linked dataset for this purpose.

Setting

Whole population of Scotland.

Participants

People aged 18+ on census day (27 March 2011), including all adults with ID (n=16 840) and a 15% randomly selected comparator sample of adults without ID (n=566 074).

Primary and secondary outcome measures

Crude and age-sex standardised incidence rates and ratios; cumulative incidence; prevalence ratios. The exposure was ID status, and the outcomes were (1) unplanned ACSC hospital admission, (2) death with an ACSC condition listed as the main cause on the death certificate and (3) death with an ACSC condition listed as one of the causes on the death certificate.

Results

Adults with ID under the age of 55 had only a slightly higher risk of an unplanned ACSC hospitalisation than their general population counterparts (standardised incidence ratio 1.11; 95% CI 1.03 to 1.20). After adjusting for different ACSC prevalence in ID and non-ID cohorts, this difference in risk disappeared. These findings contrast with existing evidence from England, where a much higher unadjusted risk of unplanned ACSC hospitalisations was found among people with ID. Adults with ID had a higher risk of dying due to ACSC than adults without ID (standardised mortality ratio 2.54; 95% CI 2.19 to 2.95).

Conclusions

Our findings on unplanned ACSC hospitalisations suggest that the primary care system in Scotland appears to be similarly effective for adults with ID than for adults without ID. However, the higher risk of dying from ACSC among people with ID suggests that this system is less effective for people with ID. Future research should investigate this tension and aim to understand why the operation of the primary healthcare system seems to be worse with regards to ACSC mortality than with regards to unplanned ACSC hospitalisations.

☐ ☆ ✇ BMJ Open

ReFIT study (reversing frailty in transplantation): protocol for a longitudinal study to assess clinical and biomedical changes in frailty through kidney transplantation

Por: Payne · T. · Shaw · A. · Hanjani · L. S. · Homes · R. · Giddens · F. · Ravuri · H. G. · Yap · C. X. · Walsh · J. · Kumar · V. · Garton · F. C. · Rhee · H. · Huang · A. · Francis · R. S. · Reid · N. · McAdams-DeMarco · M. · Gordon · E. · Midwinter · M. · Hubbard · R. — Marzo 2nd 2026 at 13:30
Introduction

Losses of functional reserve across multiple physiological systems have been identified in frail patients, yet the exact aetiology of frailty remains unclear. Although strongly associated with chronological age, frailty often develops at a younger age in patients with organ failure. Frailty is prevalent in patients with kidney failure; however, individuals experience improvements in physical frailty measures following kidney transplantation. This makes younger patients with kidney failure a unique population for studying both the accelerated onset of frailty and its reversal. This research project aims to test the hypothesis that frailty secondary to organ failure and age-related frailty are associated with similar molecular and physiological measures.

Methods and analysis

This longitudinal study will recruit 150 patients in three groups. Group A (kidney transplant recipients aged ≥40 years; n=50) and Group B (patients aged ≥40 years active on the kidney transplant waitlist; n=50) will comprise younger adults with frailty from organ failure. Group C (adults aged ≥65 years (or ≥55 years for Aboriginal and Torres Strait Islander patients); n=50) will comprise older community dwellers. The primary outcome is the Frailty Index (FI). Secondary outcomes include the change in FI over time, and at baseline when considering various clinical metadata, immune parameters, kidney function and nutrition intake which will be measured at baseline and 12-month time points. Longitudinal changes in frailty will be analysed using linear mixed models with multiple testing corrections for false discovery rates.

Endocrine profiles and metabolomics, measures of immune function and microcirculatory dysfunction, will be measured by liquid chromatography-mass spectrometry and/or gas chromatography-mass spectrometry. The gut microbiome will be sequenced via shotgun metagenomics (Illumina NextSeq500, 150 bp paired-end, 3Gbp/sample). Circulating cell-free DNA/mitochondrial DNA will be quantified through droplet digital PCR. Microcirculation will be assessed via sublingual dark field videomicroscopy with glycocalyx markers measured by ELISA.

Ethics and dissemination

This study will be conducted with all stipulations of this protocol, and the conditions of the ethics committee approval. Ethical principles have their origin in the Declaration of Helsinki, all Australian and local regulations and in the spirit of the standard of Good Clinical Practice (as defined by the International Conference on Harmonisation). Organs/tissues will be sourced ethically and will not be sourced from executed prisoners or prisoners of conscience or other vulnerable groups.

Ethics approval was received by the Metro South Health Research Ethics Committee (HREC/2023/QMS/95392) and ratified by the University of Queensland.

Results will be disseminated through peer-reviewed publications, academic conferences, participant newsletters and health organisation collaboration.

☐ ☆ ✇ BMJ Open

Beyond the doctors office: a longitudinal study mapping womens experiences of the maternal healthcare journey as a pathway to reducing maternal mortality in Nigeria

Por: Ope · B. W. · Attwood · P. · Mullins · E. · Hirst · J. E. · Norton · R. · Peden · M. — Marzo 2nd 2026 at 13:30
Objectives

Nigeria has one of the highest maternal mortality burdens globally. Improving maternal outcomes requires a better understanding of how women experience care across pregnancy, childbirth and the postnatal period. This study explored women’s maternal healthcare experiences across the perinatal continuum in Nigeria, with a focus on how challenges emerge and interact over time.

Design

Longitudinal qualitative study using patient journey mapping.

Setting

Public primary, secondary and tertiary healthcare facilities in Abuja, Nigeria.

Participants

12 pregnant women were purposively sampled. Each woman participated in two rounds of in-depth interviews: once in late pregnancy and again 2–6 weeks postpartum. All participants completed both interview rounds.

Methods

Data were collected through 24 semistructured in-depth interviews conducted longitudinally to capture changes in women’s experiences before and after childbirth. Interview guides were informed by existing maternal health frameworks. Transcripts were analysed using reflexive thematic analysis and organised across five stages of the maternal healthcare journey: Awareness, Consideration, Access, Treatment and Recovery.

Findings

This study introduces a five-stage framework: Awareness, Consideration, Access, Treatment and Recovery, to comprehensively explore maternal healthcare experiences. The findings reveal systemic inefficiencies at every stage of the pregnancy journey, from limited awareness of pregnancy test kits to unreliable booking systems and inadequate postpartum mental health support. This study highlights how early-stage barriers cascade into later phases, unlike traditional research that focuses only on clinical interactions. This study emphasises the importance of maternal care accessibility and recovery support, moving beyond a treatment-centric lens. 

Conclusion

This study presents a transformative framework for understanding maternal healthcare as a continuum of interconnected experiences. The research offers actionable insights to enhance maternal health outcomes through stage-specific strategies. The globally adaptable framework provides policymakers and healthcare practitioners with a roadmap to improve maternal healthcare systems in Nigeria and beyond. This holistic approach lays the foundation for reducing maternal mortality while ensuring equitable care for all.

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