FreshRSS

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☐ ☆ ✇ BMJ Open

Sociodemographic and clinical factors associated with non-adherence to stroke medication: an analytical, multi-hospital cross-sectional survey in Punjab, Pakistan

Por: Arshed · M. · Gillani · A. H. · Kiran · M. · Ashraf · W. · Virk · M. K. S. · Umer · M. F. · Samkari · J. A. · Arshad · H. · Qamer · S. · Shahbaz · S. · Howard · N. · Fang · Y. — Noviembre 13th 2025 at 12:41
Objective

Studying issues related to stroke medication non-adherence is essential for secondary prevention of stroke. This study aimed to identify the prevalence of medication non-adherence and risk factors among stroke survivors. The reasons behind this are that some patients may not follow stroke medication plans, and potential ways to help patients adhere better to medication plans.

Design

This study employed a cross-sectional patient survey.

Setting

The study was conducted in 20 public and private healthcare facilities in a resource-constrained setting, in Punjab, the largest province of Pakistan.

Participants

We included 6538 stroke survivors aged 21–75 years with at least a 6 month history of stroke who were prescribed one or more anti-stroke medications and met the inclusion criteria.

Primary outcome measures

The main outcome was medication non-adherence, measured by the Self-Efficacy for Appropriate Medication Scale (SEAMS) and self-reported pill count. Descriptive statistics were used to summarise study variables. chi-square (²)/Fisher’s exact test and independent t-test/ANOVA were employed. A generalised linear model (logit model using multivariable logistic regression shows that several factors are associated with medication non-adherence and adherence. Odds ratio (OR) plots were generated using Seaborn and Matplotlib.

Results

Non-adherence based on pill counts was 49.7%, while the mean SEAMS score (31.3±7.7) showed moderate self-reported adherence. After adjusting for age, gender, marital status, education, income, health insurance, smoking status, comorbidities, stroke type, disease duration, blood pressure control, number of medications, dosing frequency, physiotherapy continuation, perceived side effects and doctor-patient satisfaction, we found that female gender (vs male: AOR 0.31, 95% CI 0.27 to 0.35), lower income (10k–25k PKR vs >100k PKR: AOR 0.31, 95% CI 0.23 to 0.41; 26k–50k PKR vs >100k PKR: AOR 0.57, 95% CI 0.47 to 0.68), primary/secondary education (vs postgraduate: AOR 0.74, 95% CI 0.64 to 0.87), controlled BP (vs uncontrolled: AOR 0.66, 95% CI 0.59 to 0.73), longer disease duration (≥5 years vs

Conclusion

This study addresses the significant issue of medication non-adherence in stroke patients in Pakistan, reflecting global patterns yet remaining under-explored locally. It emphasises the critical role of adherence in managing chronic conditions such as stroke, where consistent use of preventive therapies is vital for reducing recurrence and improving outcomes. While the non-adherence rates are consistent with global trends, there is a notable lack of observational studies and epidemiological data in the Pakistani context. Our findings support a comprehensive approach to enhance medication adherence, taking into account the complex connections among social, behavioural and clinical factors. It also highlights the importance of maintaining detailed records to monitor adherence trends, identify high-risk groups and inform targeted public health interventions.

☐ ☆ ✇ BMJ Open

A mixed-methods evaluation of a peer-led, co-produced, asset-based intervention for early diagnosis of prostate cancer for Black men: the PROCAN-B study

Por: Christie-de Jong · F. · Eberhardt · J. · Oyeniyi · O. S. · Ratcliffe · E. · Kabuye · J. · Kalemba · M. · Nnyanzi · L. A. · Murphy · M. K. · Robb · K. A. — Noviembre 10th 2025 at 05:24
Objective

To pilot a culturally tailored, peer-led, co-produced asset-based intervention workshop to encourage early diagnosis of prostate cancer for Black men.

Design

Mixed-methods pilot study.

Setting

Community centres in the North-East of England and Scotland.

Participants

The intervention was delivered in November 2023 with Black African and Caribbean men (n=21), and again in February 2024 (n=41). Participants were highly educated and aged between 42 and 63 years. The intervention was qualitatively evaluated with 40 of the intervention participants.

Intervention

Underpinned by the Integrated Screening Action Model (I-SAM), we co-produced a culturally tailored, peer-led 2-hour workshop consisting of multiple components, including small group discussions about barriers to accessing prostate cancer care, general practitioner (GP) health education, activities to facilitate effective communication with the GP and reception staff and videos with testimonials from survivors, women and religious leaders.

Primary outcomes

Knowledge, attitudes and intention to engage in prostate cancer testing were examined through a pre- and post-survey design. Intervention acceptability was qualitatively explored through focus groups.

Results

Participants (n=41) reported that the workshop increased their confidence in engaging with healthcare providers to discuss prostate cancer testing (I-SAM component: psychological capability). Knowledge (I-SAM component: psychological capability: Z=4.939, p

Conclusion

Asset-based strategies, focusing on community strengths, including faith-based health promotion, can promote health behaviours in a culturally and spiritually meaningful way. The PROCAN-B intervention effectively targeted components within the I-SAM and shows potential to increase prostate cancer awareness and build confidence to engage in behaviours conducive to early diagnosis. However, the sample was small, and more robust effectiveness testing is needed.

☐ ☆ ✇ BMJ Open

Validation and cost-effectiveness of an mHealth tool for cognitive impairment detection in Peru: protocol for the IMPACT Salud observational study

Por: Cardenas · M. K. · Anza-Ramirez · C. · Bernabe-Ortiz · A. · Custodio · N. · Montesinos · R. · Miranda · J. J. · Da Re · M. · Belon-Hercilla · M. V. · Lazo-Porras · M. · Hawkins · J. · Diez-Canseco · F. · Moore · G. · Whiteley · W. · Calvo · R. A. · Cuba-Fuentes · M. S. · Landeiro · F. — Noviembre 10th 2025 at 05:24
Introduction

Dementia is a chronic and progressive neurological condition characterised by cognitive and functional impairment. It is often associated with multimorbidity and imposes a significant economic burden on healthcare systems and families, especially in low-income and middle-income countries. In Peru, where dementia cases are increasing rapidly, timely detection and referral for diagnosis is crucial. This protocol is part of the IMPACT Salud project in Peru. Here, we focus on a specific component aimed at validating an mHealth tool for the detection of cognitive and functional impairment and assessing its cost-effectiveness. We will also assess changes in cognitive and functional impairment as well as health economic outcomes over 1 year.

Methods and analysis

This observational study will be conducted in four geographically diverse regions of Peru. Community health workers are expected to contact approximately 32 000 participants (≥60 years) to apply an mHealth-enabled tool that includes cognitive and functional instruments: Ascertain Dementia 8, Peruvian version of Rowland Universal Dementia Assessment Scale and Pfeffer Functional Activities Questionnaire. From this large sample, we aim to find 3600 participants and their study partners to enrol and interview at baseline regarding sociodemographic characteristics, lifestyles, comorbidities and health economic data including resource use, costs and health-related quality of life (HR-QoL). Psychologists, blind to previous results, will assess dementia stage of the participants using an abbreviated Clinical Dementia Rating (CDR) scale. At 6-month follow-up, participants will complete a brief health economics questionnaire on resource use, costs and HR-QoL. To validate the accuracy of the detection tool, a subsample of 600 participants who completed the baseline will undergo a gold-standard clinical neuropsychological assessment. This subsample will participate in a 12-month follow-up, including health economics, cognitive and functional impairment tests and the CDR scale. Results will be analysed and presented by cognitive status, site, sex and multimorbidity profile. Finally, data from all stages and external sources will inform a decision model to implement a cost-effectiveness analysis of the detection tool at the national level.

Ethics and dissemination

The study received ethics approval in Peru (Universidad Peruana Cayetano Heredia: CONSTANCIA-CIEI-378-33-23) and in the UK (Imperial College London: ICREC/SETREC reference number 6647445). Informed consent will be obtained from participants and their study partners, considering the participant’s capacity to consent. For illiterate participants, consent will be obtained through a witnessed procedure involving study partners, with a fingerprint obtained instead of a signature. The results will be disseminated through conferences, published articles, public presentations (particularly to those involved in dementia care) and presentations or meetings with local health authorities.

☐ ☆ ✇ BMJ Open

Mixed-methods longitudinal evaluation of the mental health first aid (MHFA) for freshman university students in Hong Kong: a study protocol

Por: Capio · C. M. · Kwok · M. K. · Liu · T. W. · Wong · W. K. · Wong · J. Y.-H. — Noviembre 5th 2025 at 06:23
Introduction

The mental health first aid (MHFA) training is an evidence-based programme that is known to improve undergraduate students’ attitudes towards mental illness and confidence in helping people with mental health problems. MHFA training will be implemented at a university in Hong Kong to address growing concerns about mental health challenges among students. Given the context of a university-wide systematic MHFA training implementation, this evaluation uses an intervention logic framework to evaluate the processes and longitudinal outcomes.

Methods and analysis

A mixed-method approach will be used where the quantitative component will gather data from a review of records and a case-control study for outcome evaluation; the qualitative component will gather data from individual interviews. All first-year students from the university in the academic year 2024–2025 (ie, September 2024 to August 2025) will be enrolled in the mandatory MHFA training. The outcome evaluation will assess effectiveness through short-, intermediate- and long-term outcomes. An online questionnaire will be distributed to the students before (pre) and immediately after (post) the MHFA training. For comparison, second-year students who had not participated in MHFA training will be invited to complete the same online questionnaire. The questionnaires will be administered further to those who completed the MHFA training at 12 months (ie, academic year 2025–2026) and 24 months (ie, academic year 2026–2027) post-training to evaluate intermediate-term and long-term effects, respectively. The process evaluation explores feasibility, fidelity, adoption and the barriers and enablers to implementation.

Ethics and dissemination

This evaluation has been approved by the Human Research Ethics Committee of Hong Kong Metropolitan University (reference number HE-SF2024/35). The findings are expected to contribute to establishing long-term effects on mental health literacy and on the actual mental health support actions provided by participants, which goes beyond the intention to help. This evaluation would also facilitate a better understanding of the processes that need to be considered in a systematic MHFA training implementation in a university context. The findings will be disseminated in academic and public health community settings.

Data statement and project registration

This project has been registered in the Open Science Framework. Fully anonymised data will be saved and subsequently made available through the following OSF registration: https://doi.org/10.17605/OSF.IO/92N5Q.

☐ ☆ ✇ PLOS ONE Medicine&Health

Effect of semen dilution rate and dimethyl acetamide levels on post-thaw motility and fertility parameters of rooster sperm

by Mohamed Shawky, Ahmed F. Fawy, Ahmed M. Elomda, Mohamed A. Elmenawey, Abd El-Rahman M. Atta, Ahmed O. Abbas, Gamal M. K. Mehaisen

This study evaluated the impact of pre-freezing semen dilution rate and dimethyl acetamide (DMA) concentration on the post-thaw motility and fertility of cryopreserved rooster sperm. Rooster ejaculates were diluted with a standard EK extender to achieve low (LSC; 1 × 10⁹ sperm/mL) and high (HSC; 2 × 10⁹ sperm/mL) sperm concentrations. Each dilution group was further treated with three DMA concentrations (3%, 6%, or 9%) before cryopreservation. Post-thaw sperm motility traits were obtained by computer-assisted sperm analysis (CASA), and fertility features were evaluated through artificial insemination in hens. The current results showed that HSC significantly improved total motility (TM), curvilinear velocity (VCL), amplitude of lateral head displacement (ALH), and beat cross frequency (BCF), but reduced linearity (LIN) and straightness (STR) compared to LSC. DMA concentration had a quadratic effect on motility, with 6% yielding the highest progressive motility (PM), straight line velocity (VSL), and BCF. Fertility outcomes revealed that HSC resulted in higher fertilization rates, while neither DMA concentrations nor their interaction with dilution rates exerted significant effects on fertility traits. VCL, ALH, and BCF showed positive correlations with pipping-chicks rates, whereas STR, LIN, and WOB displayed negative correlations. These findings underscore the critical interplay between dilution rate and cryoprotectant concentration and provide practical guidance for developing more reliable cryopreservation protocols that can be applied under field conditions to enhance fertility management in poultry production.
☐ ☆ ✇ BMJ Open

Association between voice-activated technology interventions and well-being in older adults living alone: a protocol for a systematic review and meta-analysis

Por: Kang · B. · Hong · D. · Park · M. K. · Park · S. · Jeong · S. · Park · Y. S. — Octubre 29th 2025 at 16:48
Introduction

A growing number of community-dwelling older adults living alone face a range of physical, psychological and social challenges that negatively impact their well-being. Various technologies have been developed to support healthy ageing, with voice-activated technology (VAT) offering particularly promising opportunities to improve later life well-being. However, its effect on older adults living alone has not yet been systematically evaluated. Thus, this study aims to provide an evidence base for the effectiveness of VAT interventions in enhancing the physical, psychological and social well-being of older adults living alone.

Methods and analysis

We will conduct a systematic review and meta-analysis of studies examining the use of VAT interventions among older adults living alone. The eligible study designs include randomised controlled trials and quasi-experimental studies. Primary outcomes will focus on physical, psychological and social well-being. A comprehensive search will be conducted across international (PubMed, Embase, Cochrane Library, CINAHL, PsycINFO, ProQuest and Web of Science) and Korean databases (RISS, DBpia and KISS). Two reviewers will independently conduct study selection, risk-of-bias assessment and data extraction. A meta-analysis will be conducted to synthesise the effects of VAT interventions on psychological, physical and social domains of well-being.

Ethics and dissemination

Synthesising existing evidence, this review aims to inform the development of targeted interventions and support strategies to improve the well-being of older adults living alone. As no new data will be collected, ethical approval is not required. Findings will be published in a peer-reviewed journal to guide targeted intervention strategies and engage both academic and policy audiences.

PROSPERO registration number

CRD420251084621.

☐ ☆ ✇ BMJ Open

Family caregiver burden and associated factors among caregivers of people with mental illness attending outpatient treatment in public hospital in Eastern Ethiopia, Ethiopia: hospital-based cross-sectional study

Por: Leta · F. O. · Genna · K. M. · Ibirahim · M. K. · Dechasa · T. D. — Octubre 28th 2025 at 18:00
Objective

To assess family caregiver burden and associated factors among caregivers of people with mental illness in Eastern Ethiopia.

Design

Cross-sectional study.

Setting

Three hospitals in Eastern Ethiopia.

Participants

A total of 422 family caregivers of people with mental illness were recruited using systematic random sampling, of whom 417 participated (response rate 98.8%).

Primary outcome measures

Caregiver burden was assessed using the Zarit Burden Interview (ZBI-22). Linear regression was used to measure the associations between dependent and independent variables.

Results

The mean score of the ZBI was 47.971 (SD=14.539). In our study, factors associated with caregiver burden included age of caregivers (β=0.143, p=0.006), sex of the caregiver (β=0.121, p=0.007), time spent in providing care (β=0.194, p=0.006), presence of comorbid medical illness (β=0.309, p0.001), substance use in the last 12 months (β=0.265, p=0.024), perceived stigma (β=0.207, p

Conclusions

89 (22.2%) of caregivers reported severe burden and 220 (52.8%) reported moderate-to-severe burden. Family caregivers play a critical role in the treatment of mental illness; there is a need to establish family caregiver support services, such as group therapy and psychoeducation.

☐ ☆ ✇ BMJ Open

Study protocol for an open-label, single-arm, mixed methods feasibility study of the MWIQ AI-powered decision support tool for diabetes management in GP practices

Por: Dickson · J. · Cunningham · S. G. · Sainsbury · C. · Rutter · M. K. · Kanumilli · N. · Pearson · E. · Brodie · D. · Stevens · M. · Wake · D. J. · Conway · N. — Octubre 6th 2025 at 02:14
Introduction

Diabetes affects ~10% of the world’s population and is rising. Treatment costs in the UK are ~15% of the NHS budget. Diabetes-related complications can be lowered through better evidence-based clinician management and patient self-management. MyWay intelligence quotient (MWIQ) is an electronic platform that will provide clinical decision support around the diagnosis and treatment of patients with diabetes. This study evaluates the safety and clinical performance (clinical appropriateness/applicability, clinical impact and clinical usability) of MWIQ.

Methods and analysis

The system will be implemented in real time in four to seven general practitioner (GP) practices. Clinicians with diabetes expertise will be recruited as validators, who will inspect records to ensure system robustness before use, and up to 14 healthcare professionals will use and evaluate the system.

Quantitative and qualitative analyses will be triangulated to assess the MWIQ system. Assessment of clinical outcomes will be made using pseudonymised routinely collected clinical data, including adherence to quality performance indicators, diabetes diagnosis, diabetes investigations (eg, genetic testing), HbA1c, blood pressure, body mass index, cholesterol and foot risk score for the diabetes population concerned. Clinical and validator participants will also submit a weekly questionnaire, and these, along with interviews, which are scheduled during the testing process, will be analysed to provide data on the utility, safety and usability of the system.

Ethics and dissemination

This study was approved, 08/01/2024, by the North of Scotland Research Ethics Committee (REC), IRAS project ID: 305267, REC, reference 23/NS/0134. The study has gained confidentiality advisory group (CAG) support (reference: 24/CAG/0002), medicines and healthcare products regulatory agency (MHRA) and health research authority (27/08/2024) approvals.

Findings will be reported to (1) The funding body, (2) The participating GP practices, (3) The study PPIE group, (4) The MHRA to support a submission for recognition as a class 2 CE/UKCA marked device, (5) Presented at local, national and international conferences and (6) Disseminated by peer-reviewed publications.

Trial registration number

ISRCTN17422256.

☐ ☆ ✇ BMJ Open

Identification of gestational diabetes mellitus in European electronic healthcare databases: insights from the ConcePTION project

Por: Molgaard-Nielsen · D. · Mitter · V. · Lupattelli · A. · Hoxhaj · V. · Andaur Navarro · C. L. · Hayati · S. · Lopez-Leon · S. · Morris · J. K. · Geldof · A. · Jordan · S. · Leinonen · M. K. · Martikainen · V. · Manfrini · M. · Cammarota · L. · Neville · A. · Barrachina-Bonet · L. · Cave — Octubre 6th 2025 at 02:14
Objective

To develop and compare algorithms for identifying gestational diabetes mellitus (GDM) across European electronic healthcare databases and evaluate their impact on the estimated prevalence.

Design

Multi-national cohort study using routinely collected electronic healthcare data

Setting

National and regional databases in five European countries (Norway, Finland, Italy, Spain and France), in primary and/or secondary care.

Participants

Pregnancy cohorts resulting in stillbirths or live births between 2009 and 2020, comprising 602 897 pregnancies in Norway, 507 904 in Finland, 374 009 in Italy, 193 495 in Spain and 116 762 in France.

Primary and secondary outcomes

The primary outcome was the prevalence of GDM identified using six algorithms: (1) Only diagnosis; (2) Diagnosis or prescription; (3) Two diagnoses or prescriptions (2DxRx); (4) Diagnosis including unspecified diabetes in pregnancy or prescription (DxRx broad); (5) Diagnosis excluding pre-existing diabetes in pregnancy or prescription; (6) Registration of GDM in a birth registry (BR).

Results

The strictest algorithm (2DxRx) resulted in the lowest GDM prevalence, while the broadest (DxRx broad) resulted in the highest, except in France where it was BR. In the Nordic countries, GDM prevalence varied only slightly by algorithm; greater variations were observed in other countries. The prevalence ranged from 3.5% (95% CI: 3.5% to 3.5%) to 4.6% (95% CI: 4.5% to 4.7%) in Norway; 12.1% (95% CI: 12.0% to 12.2%) to 15.8% (95% CI: 15.7% to 15.9%) in Finland, where prevalence was much higher than elsewhere. The prevalence ranged from 1.3% (95% CI: 1.3% to 1.3%) to 5.4% (95% CI: 5.3% to 5.5%) in Italy; 1.6% (95% CI: 1.5% to 1.7%) to 6.2% (95% CI: 6.1% to 6.3%) in Spain; and 1.7% (95% CI: 1.6% to 1.8%) to 5.8% (95% CI: 5.7% to 5.9%) in France.

Conclusions

In this multinational study, GDM prevalence ranged from 1.3% to 15.8% depending on the algorithm and database. Nordic countries showed smaller differences in prevalence between algorithms, while the other countries showed larger variations, likely due to differences in coding practices, healthcare systems and database coverage.

☐ ☆ ✇ BMJ Open

Integrating social drivers of health screening and management into prenatal care: protocol for a mixed-methods implementation evaluation

Por: Anderson · P. · Neustrom · V. · Hepting · S. · Menard · M. K. · Cash · K. · Gbozah · K. · Tang · J. — Octubre 6th 2025 at 02:14
Background

Social drivers of health (SDOH), such as housing stability, food security and access to transportation, profoundly influence both healthcare access and health outcomes. In pregnancy, screening positively for SDOH domains correlates with poorer perinatal outcomes. While the American college of Obstetricians and Gynaecologists recommends screening for SDOH at every routine prenatal visit, many prenatal practices struggle to systematically screen patients for SDOH. This study evaluates the implementation of a universal SDOH screening and management protocol in prenatal care and aims to bridge the gap between the recommendation for universal SDOH screening in prenatal care and its actual integration by evaluating implementation strategies that can serve as a guide for other prenatal care clinics.

Methods and analysis

This multi-site, prospective formative implementation evaluation will assess the integration of standardised SDOH screening and management into prenatal care workflows at four prenatal clinic sites within an academic Obstetrics and Gynaecology department. The study employs a concurrent triangulation mixed-methods approach integrating chart-abstracted patient data, staff surveys, and staff and patient semi-structured interviews, guided by established implementation science frameworks (exploration, preparation, implementation and sustainment, consolidated framework for implementation research and implementation outcomes framework). Key implementation strategies include workflow integration, electronic medical record optimisation, role clarification and comprehensive training. Implementation outcomes to be evaluated include feasibility, acceptability, appropriateness, adoption, fidelity and sustainability.

Ethics and dissemination

This study was approved by the University of North Carolina at Chapel Hill’s Institutional Review Board (IRB #24-3104). Verbal informed consent will be obtained from all interview participants, and consent will be embedded in staff surveys. Results will be disseminated through peer-reviewed publications, conference presentations, stakeholder meetings and directly to participating clinical sites.

☐ ☆ ✇ BMJ Open

Improving reproducibility of data analysis and code in medical research: 5 recommendations to get started

Por: Streiber · A. M. · Hoepel · S. J. W. · Blok · E. · van Rooij · F. J. A. · Neitzel · J. · Labrecque · J. · Ikram · M. K. · Bos · D. — Octubre 3rd 2025 at 06:32

Due to the growing use of high-dimensional data and methodological advances in medical research, reproducibility of research is increasingly dependent on the availability of reproducible code. However, code is rarely made available and too often only partly reproducible. Here, we aim to provide practical and easily implementable recommendations for medical researchers to improve the reproducibility of their code. We reviewed current coding practices in the population-based Rotterdam Study cohort. Based on this review, we formulated the following five recommendations to improve the reproducibility of code used in data analysis: (1) make reproducibility a priority and allocate time and resources; (2) implement systematic code review by peers, as it further strengthens reproducibility. We provide a code review checklist, which serves as a practical tool to facilitate structured code review; (3) write comprehensible code that is well-structured; (4) report decisions transparently, for instance by providing the annotated workflow code for data cleaning, formatting and sample selection; and (5) focus on accessibility of code and data and share both, when possible, via an open repository to foster accessibility. Ideally, this repository should be managed by the institution and should be accessible to everyone. Based on these five recommendations, medical researchers can take actionable steps to improve the reproducibility of their research. Importantly, these recommendations are thought to provide a practical starting point for enhancing reproducibility rather than mandatory guidelines.

☐ ☆ ✇ BMJ Open

Leveraging emotional intelligence to alleviate mental health: protocol of a cluster randomised controlled trial among parents of children with neurodevelopmental disorders in Bangladesh

Por: Salwa · M. · Chowdhury · S. M. · Rois · R. · Uddin · M. K. · Akhter · S. · Nahar · K. · Mullick · A. R. · Mannan · M. · Kundu · G. K. · Fatema · K. · Maruf Haque Khan · M. · Haque · M. A. — Septiembre 30th 2025 at 09:49
Background

Parents of children with neurodevelopmental disorders often experience high levels of stress that impact their mental health, yet few interventions focus on their well-being. To address this gap, we developed a mental health intervention based on emotional intelligence (EI), designed for delivery in healthcare settings. We hypothesise that enhancing EI can reduce parenting stress and improve psychological well-being. This study aims to assess the effectiveness, cost-effectiveness and feasibility of this EI-based intervention in Bangladesh.

Methods and analysis

This hybrid type 1 effectiveness-implementation study will include a cluster randomised controlled trial, an implementation analysis and an economic evaluation. Eight child development centres will be randomly assigned in a 1:1 ratio to intervention and waitlist control groups. A total of 480 parents (mothers and fathers) will be recruited. The intervention consists of interactive sessions on EI skills, supported by personal diaries and a mobile app. Data will be collected at baseline and 12 weeks postintervention using validated tools to assess EI, parenting stress, psychological well-being and other mental health outcomes. Implementation will be evaluated using mixed methods to assess feasibility, acceptability and fidelity. Cost-effectiveness will be determined through a cost–utility analysis of direct and indirect costs.

Ethics and dissemination

Ethical approval was granted by the Institutional Review Board of Bangladesh Medical University (BSMMU/2022/10733). Written informed consent will be obtained at each stage of data collection and intervention. Findings will be disseminated through open-access publications, plain-language summaries, academic conferences, community workshops and policy briefs. Data will be shared in open-access platforms to inform mental health strategies in low-resource settings globally.

Trial registration number

NCT06166550.

☐ ☆ ✇ BMJ Open

Retrospective analysis of value-driven outcomes of diabetic foot ulcer in a tertiary hospital in Singapore

Por: Chia · A. C. K. · Tan · I. E.-H. · Tan · Z. N. · Yeo · W. J. · Zhao · Y. · Yap · C. J. Q. · Ang · K. A. · Au · M. K. H. · Chong · T. T. — Septiembre 29th 2025 at 07:52
Objective

This study analysed the clinical outcomes and healthcare costs associated with diabetic foot ulcer (DFU) within a tertiary healthcare centre in Singapore.

Design

This is a retrospective, single-centre study. Patient data were extracted from the hospital’s electronic health system, including demographic, clinical and hospitalisation information. Hospitalisation costs were categorised into DFU-related and other hospitalisation costs. A one-way sensitivity analysis was performed to estimate the total healthcare costs associated with DFU.

Setting

Tertiary centre within a population suffering from a diabetic epidemic.

Participants

All patients aged 18 years or older who received DFU treatment between January 2019 and December 2023 at the Singapore General Hospital were included.

Results

A total of 2857 DFU patients were included in the study. In-hospital mortality remained stable at 5%–6% annually. Among the cohort, 39.1% underwent minor amputations, 19.6% had major amputations and 9.0% experienced both minor and major amputations. The median length of stay for surgical patients ranged from 10 (IQR 4–24) to 13 days (IQR 6–31), compared with 4 (IQR 2–8) to 5 (IQR 3–9.5) days for non-surgical patients. Total costs per admission for patients with DFU-related surgery ranged from US$28 588.96 to US$34 204.77, while for those without surgery, costs ranged from US$6637.59 to US$7955.23. Total hospitalisation costs for DFU during the study period ranged from US$65.87 million to US$72.16 million. All figures were inflation adjusted to 2023 US dollars.

Conclusions

DFU poses a significant clinical and economic burden in Singapore. Understanding the costs associated with DFU is essential for resource allocation and planning in DFU management.

☐ ☆ ✇ BMJ Open

Evidence map of oesophageal surgery: protocol for a living systematic review and meta-analysis

Por: Benignus · C. · Schiedeck · T. · Avramovska · I. · Evers · L. M. · Giulini · L. · Heger · P. · Diener · M. K. · Hüttner · F. J. — Septiembre 19th 2025 at 06:54
Introduction

Surgery represents the cornerstone for the treatment of several benign and malignant oesophageal disorders. Yet synthesising the growing body of evidence from clinical research is becoming increasingly challenging. Evidence mapping with living systematic reviews (SRs) and living meta-analyses offers a structured, continuously updated approach to navigating emerging data. This study aims to provide a real-time, interactive resource to support evidence-based decision-making for oesophageal surgery.

Methods and analysis

This study follows PRISMA guidelines and uses the EVIglance Studio web application to develop a living evidence map in oesophageal surgery. A systematic literature search will be conducted across the Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science and MEDLINE (PubMed) to identify randomised controlled trials (RCTs) and SRs related to oesophageal surgery, without any date or language restrictions. Study selection and data extraction will be performed independently by two reviewers. Key clinical and surgical outcomes, including morbidity, mortality, quality of life and oncological endpoints, will be extracted. Risk of bias in RCTs will be assessed using the Cochrane Risk of Bias 2.0 tool, and the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) system will be applied to evaluate the certainty of evidence. If at least three randomised trials address the same research question, a living meta-analysis will be conducted using random-effects models. The evidence map will be updated at least every 6 months.

Ethics and dissemination

This study does not involve individual patient data or any private information. Therefore, ethical approval is not required. As it uses only publicly available data, this study design qualifies as exempt from institutional review. The resulting evidence map is designed to support fast and structured access to high-quality surgical data - an approach not yet available in oesophageal surgery. The tool is expected to aid patients, clinicians and researchers alike by improving access to reliable information, supporting clinical decision-making and highlighting gaps in current evidence. On completion, results will be published in an open-access format and made permanently accessible via www.evidencemap.surgery, with continuous updates.

PROSPERO registration number

CRD420251022736 (https://www.crd.york.ac.uk/prospero/)

☐ ☆ ✇ BMJ Open

Effect on healthcare professionals self-efficacy of a 45-min versus 3-hour educational intervention on communication and play in paediatric clinical practice in Denmark: a randomised controlled trial study protocol

Por: Thestrup · J. · Sorensen · J. L. · Bidstrup · P. E. · Rosthoj · S. · Hybschmann · J. · Esbjorn · B. H. · Dybdal · D. · Barslund · K. · Topperzer · M. K. · Frandsen · T. L. · Gjaerde · L. K. — Septiembre 15th 2025 at 05:56
Introduction

Communication is a professional competence that all paediatric healthcare professionals must learn and maintain to provide age and developmentally appropriate care. Child-centred communication encourages direct communication with children and adolescents, incorporating the use of play as a communicative strategy. Still, many paediatric healthcare professionals receive little or no formal training in communication and play. A critical barrier to communication training is the limited possibilities for healthcare professionals to take time from their clinical duties. Moreover, few randomised controlled trials have evaluated educational programmes on communication and play for paediatric healthcare professionals, and existing programmes vary significantly in design and duration. This study aims to compare the effects of a 45-min and a 3-hour educational intervention for healthcare professionals on age-appropriate communication and the use of play in clinical paediatric practice.

Methods and analysis

We will describe a single-centre, randomised, controlled, two-arm, non-inferiority trial. We will recruit 150 healthcare professionals with different professional backgrounds who will be randomised to one of two arms: a 45-min or 3-hour educational intervention on communication and play in paediatric clinical practice. The primary outcome will be their self-efficacy in patient-centredness at 12-week post-intervention, while secondary outcomes will be self-efficacy immediately after the intervention, motivation to engage in the educational activity, cognitive load, self-evaluated knowledge, satisfaction and the impact on individual practice and training needs. Data will be collected through questionnaires at baseline, immediately after the intervention, and 12 weeks post-intervention and will be analysed using linear mixed models with random effects to account for clustering and within-subject correlation.

Ethics and dissemination

The Danish Data Protection Agency approved the study (P-2020–1144), which will be conducted in accordance with the Declaration of Helsinki. Findings will be published in a peer-reviewed open-access scientific journal and presented at international conferences.

Trial registration number

NCT06859632 (ClinicalTrials.gov).

☐ ☆ ✇ BMJ Open

Factors associated with generalised anxiety disorder and depression among adults living with diabetes and hypertension comorbidity in rural Bangladesh: findings from a cross-sectional study

Por: Chakravartty · M. · Shuvo · M. M. S. · Kumari · S. · Jhilik · T. C. · Sarker · T. · Akter · F. · Hossain · M. M. · Ahsan · A. · Latif · M. · Mridha · M. K. — Septiembre 5th 2025 at 13:49
Objective

The rising burden of non-communicable diseases (NCDs), including mental health disorders (MHDs) such as anxiety and depression, poses a significant public health challenge globally. Evidence suggests that both diabetes and hypertension, the two most prevalent NCDs, are linked to a higher prevalence of MHDs. However, there is a lack of evidence on prevalence of generalised anxiety disorder (GAD) and depression among adults living with both diabetes and hypertension in Bangladesh. We aimed to assess the prevalence of GAD and depression and explore the associated factors among adults living with diabetes and hypertension comorbidity in rural Bangladesh.

Design

We implemented a cross-sectional study.

Setting

The study was conducted in Chirirbandar, a sub-district of Dinajpur, Bangladesh.

Participants

We interviewed a total of 387 adults living with diabetes and hypertension comorbidity.

Primary outcome measures

We had two primary outcome measures: GAD and depression. Individuals scoring ≥10 on the General Anxiety Disorder-7 scale were considered as having GAD and individuals scoring ≥10 on the Patient Health Questionnaire-9 scale were considered as having depression. The outcome variables were dichotomised based on these scores.

Results

The prevalence of GAD was 7.24% (95% CI 5.04 to 10.29). Education level (grades 5–9) (adjusted OR (AOR): 3.40, 95% CI 1.26 to 9.19) and household wealth status (highest wealth tertile) (AOR: 0.12, 95% CI 0.02 to 0.62) were associated with GAD. The prevalence of depression was 17.83% (95% CI 14.32 to 21.98). Socioeconomic factors associated with depression included unemployment (AOR: 3.26, 95% CI 1.05 to 10.10) and household wealth status (highest wealth tertile) (AOR: 0.45, 95% CI 0.21 to 0.98). Higher odds of depression were also observed among participants with controlled hypertension (AOR: 3.88, 95% CI 1.81 to 8.35). Other factors, such as tobacco use, dietary diversity and physical activity, were not associated with GAD or depression.

Conclusion

A high prevalence of GAD and depression was observed among adults living with diabetes and hypertension comorbidity. The findings from the study emphasise the need for integration of mental health services into the existing non-communicable disease care. The identified factors associated with GAD or depression should be considered to develop targeted interventions for people with hypertension and diabetes comorbidity in Bangladesh.

☐ ☆ ✇ BMJ Open

Janus kinase inhibitors in palmoplantar pustulosis: a mixed-methods feasibility (JAKPPPOT) trial protocol

Por: Gleeson · D. · Chapman · S. · McAteer · H. · Qin · A. · Gregory · J. · Pizzato · J. · Powell · K. · Sagoo · M. K. · Ye · W. · Naylor · A. · Moorhead · L. · Pink · A. E. · Woolf · R. · Barker · J. · Galloway · J. B. · Cro · S. · K Mahil · S. · Smith · C. H. — Agosto 21st 2025 at 10:00
Background

Palmoplantar pustulosis (PPP) is a rare, debilitating inflammatory skin disease involving painful pustules on the palms and soles. Janus kinase (JAK) inhibitors target pathways relevant to PPP disease biology but also confer a risk of major adverse cardiovascular events and malignancy in certain ‘at risk’ individuals; this includes those with PPP given prevalent smoking and cardiovascular risk factors in the PPP population. The feasibility of JAK inhibitor therapy for PPP requires assessment prior to a randomised controlled trial evaluation of drug efficacy and safety for this indication.

Methods and analysis

The ‘Janus kinase inhibitors in palmoplantar pustulosis: a mixed-methods feasibility’ trial is an open-label, single-centre, single-arm, mixed-methods feasibility trial of JAK inhibition in PPP (REC reference: 24/NE/0147; ISRCTN61751241). Participants (n=20) will receive 8 weeks of treatment with the JAK inhibitor upadacitinib (‘Rinvoq’, 30 mg, once daily). Qualitative semistructured interviews (up to n=40) will be undertaken with trial participants, trial decliners and healthcare professionals. The primary outcome will be a composite assessment of feasibility across three domains: recruitment, adherence and acceptability, using a mixed-methods analysis approach. Secondary objectives include the identification of trial recruitment optimisation strategies, using the ‘Quintet Recruitment Intervention’, and the generation of an indication of effect size on disease severity (measured using the Palmoplantar Pustulosis Psoriasis Area and Severity Index) to inform future sample size calculations. Historic placebo control data from the Anakinra for Pustular Psoriasis: Response in a Controlled Trial (National Institute of Health and Social Care reference: 13/50/17; Research Ethics Commitee reference: 16/LO/0436) will be used as the effect size comparator. Study recruitment will be undertaken over a 24-month period, commencing in November 2024.

Ethics and dissemination

This study has been approved by the Newcastle North Tyneside 2 Research Ethics Committee, 24/NE/0132. Our findings will inform the feasibility of a future adequately powered RCT evaluating the efficacy of JAK inhibitor therapy in PPP.

Trial registration number

ISRCTN61751241.

☐ ☆ ✇ BMJ Open

Compassion fatigue and coping strategies among healthcare providers in Central Uganda: a facility-based cross-sectional study

Por: Kabunga · A. · Kigongo · E. · Udho · S. · Auma · A. G. · Tumwesigye · R. · Musinguzi · M. · Anyolitho · M. K. — Agosto 19th 2025 at 15:52
Objective

This study aimed to investigate the relationship between coping strategies and compassion fatigue among healthcare professionals in Central Uganda.

Design

A facility-based cross-sectional study conducted between June and July 2023. Three tools were used for data collection: a socio-demographic survey, the Professional Quality of Life Scale (ProQOL-5) and the Brief-Coping, Orientation to Problem Experienced tool. Participants were asked to recall experiences from the previous 30 days.

Setting

The study was conducted in five prominent hospitals in Central Uganda.

Participants

A total of 548 healthcare providers, including 191 physicians, 256 nurses and 103 technicians.

Main outcome measures

Compassion fatigue scores.

Results

Most participants were under 29 years old (50.9%) and women (62.0%). High levels of compassion fatigue were reported by 37.8% of participants. Active coping, self-distraction and denial were associated with higher compassion fatigue, while informational support, positive reframing and venting were linked to lower fatigue levels. Seeking social support effectively reduced compassion fatigue.

Conclusion

The findings highlight significant compassion fatigue among healthcare providers in Central Uganda, impacting their well-being and patient care. Coping strategies like active problem-solving and social support are promising in mitigating compassion fatigue. Interventions should focus on reducing self-distraction, enhancing problem-solving skills and fostering supportive work environments to improve healthcare workers’ well-being and patient care quality.

☐ ☆ ✇ BMJ Open

TRIAGE-GS: protocol for a randomised controlled trial of a genomics-first approach to rare disease diagnosis for patients awaiting assessment by a clinical geneticist

Por: Stanley · K. J. · Chisholm · C. · Gillespie · M. K. · Caluseriu · O. · del Signore · N. · Elango · S. · Hartley · T. · Hewson · S. · Kim · R. H. · McSheffrey · G. · Mendoza-Londono · R. · Sawyer · S. L. · Somerville · M. · Venkataramanan · V. · White-Brown · A. · Telesca · S. · Shickh — Agosto 11th 2025 at 03:13
Introduction

Rare diseases (RD) are collectively common and often genetic. Families value and can benefit from precise molecular diagnoses. Prolonged diagnostic odysseys exacerbate the burden of RD on patients, families and the healthcare system. Genome sequencing (GS) is a near-comprehensive test for genetic RD, but existing care models—where consultation with a medical geneticist is a prerequisite for testing—predate GS and may limit access or delay diagnosis. Evidence is needed to guide the optimal positioning of GS in care pathways. While initiating GS prior to geneticist consultation has been trialled in acute care settings, there are no data to inform the utility of this approach in outpatient care, where most patients with RD seek genetics services. We aim to evaluate the diagnostic yield, time to diagnosis, clinical and personal utility and incremental cost-effectiveness of GS initiated at the time of referral triage (pre-geneticist evaluation) compared with standard of care.

Methods and analysis

200 paediatric patients referred to one of two large genetics centres in Ontario, Canada, for suspected genetic RD will be randomised into a 1:1 ratio to the intervention (GS first) or standard of care (geneticist first) arm. An unblinded, permuted block randomisation design will be used, stratified within each recruitment site by phenotype and prior genetic testing. The primary outcome measure is time to genetic diagnosis or to cessation of active follow-up. Survival analysis will be used to analyse time-to-event data. Additional measures will include patient-reported and family-reported measures of satisfaction, understanding and perceived test utility, clinician-reported measures of perceived test utility and management impact, and healthcare system utilisation and costs.

Ethics and dissemination

This study was approved by Clinical Trials Ontario. Results will be disseminated, at minimum, via peer-reviewed journals, professional conferences and internal reports to funding bodies. Efforts will be made to share aggregated study results with participants and their families.

Trial registration number

NCT06935019.

☐ ☆ ✇ BMJ Open

Psychosocial outcomes of risk-adapted prevention for prostate cancer predisposition: study protocol for a longitudinal observational mixed-methods study

Por: Klett · M. K. · Albers · P. · Lakes · J. · Niegisch · G. · Antoch · G. · Boschheidgen · M. · Dinger · U. · Fehm · T. · Jäger · B. · Redler · S. · Wieczorek · D. · Schäfer · R. · Carl · G. · Karger · A. — Julio 21st 2025 at 02:01
Introduction

Prostate cancer (PCa) is the second most common cancer in men worldwide and genetic factors and family history significantly increase the risk of PCa. Men at increased risk for PCa often experience higher PCa-specific anxiety and distress. Comprehensive prevention strategies for men with familial or genetic PCa predisposition are lacking. Consequently, the psychological impact, facilitators and barriers for risk-adapted PCa prevention lack comprehensive study. The novel prospective registry and prevention clinic ‘ProFam-Risk’ (prevention clinic for familial PCa risk) at the University Hospital Düsseldorf offers personalised risk assessment and risk-adapted prevention recommendations for men with familial or genetic PCa predisposition. As part of this research project, this study (‘ProFam-Psych’ - risk-adapted prevention clinic for familial and genetic prostate cancer: psychosocial effects; funded by German Cancer Aid) aims to evaluate the longitudinal psychosocial trajectories associated with this novel prevention clinic.

Methods and analysis

In a longitudinal observational mixed-methods design, psychosocial outcomes will be assessed in participants of the prevention clinic (case group, CAG) and compared with urology patients without increased risk for PCa (control group, COG). Psychosocial outcomes will be collected at four time points in the CAG (T0: baseline; T1: after first visit; T2: after risk stratification consultation; T3: follow-up 6 months after T2) and at two time points in the COG (T0: baseline during inpatient stay; T1: post-inpatient stay). Recruitment started in 2023, and the recruitment target is n=225 participants (CAG) and n=118 participants (COG). Primary endpoint is the longitudinal course of PCa-specific anxiety (Memorial Anxiety Questionnaire for Prostate Cancer) in the CAG. Secondary endpoints include the comparison of T0 and T1 outcomes between the CAG and COG and the assessment of changes in perceived PCa risk and perceived personal control in the CAG. To assess facilitators and barriers to participation in the risk-adapted PCa prevention clinic, a minimum of n=12 semi-structured qualitative interviews will be conducted, with recruitment continuing until data saturation is reached. Qualitative data will be analysed using qualitative content analysis.

Ethics and dissemination

Ethics approval from the Medical Faculty of the Heinrich Heine University Düsseldorf was obtained (2023-2551). Results of the main objective and each of the secondary endpoints will be submitted for publication in a peer-reviewed journal.

Trial registration number

DRKS.de, DRKS00032350. Prospectively registered with the German Clinical Trials Register (DRKS) on 14 September 2023.

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