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☐ ☆ ✇ BMJ Open

Reduced-fluence photodynamic therapy versus placebo for central serous chorioretinopathy (REPLAY trial): rationale and study protocol of a pivotal double-blind randomised controlled trial

Por: Miyake · M. · Takahashi · A. · Baba · T. · Maruko · I. · Ohnaka · M. · Kuroda · A. · Tada · H. · Hidaka · Y. · Ibi · Y. · Muraoka · Y. · Ito · T. · Morita · S. · Sakamoto · T. · Imai · H. · Yamamoto · S. · Iida · T. · Tsujikawa · A. — Abril 21st 2026 at 12:58
Introduction

Chronic central serous chorioretinopathy (CSC) can cause progressive and permanent vision loss. Although photodynamic therapy (PDT) is a primary treatment option globally, it is not approved for CSC worldwide, limiting therapeutic access. The REPLAY trial is a phase III, investigator-initiated trial to evaluate the efficacy and safety of reduced-fluence PDT (rf-PDT) for chronic CSC to seek the first regulatory approval globally.

Methods and analysis

This study comprises two cohorts. The ‘untreated cohort’ is a multicentre, randomised, placebo-controlled, double-masked trial involving 60 patients with untreated, fovea-involving chronic CSC, randomised 2:1 to receive a single rf-PDT or placebo treatment. The ‘previously treated cohort’ is a single-arm, open-label trial for up to 10 patients with recurrent CSC after PDT. The primary endpoint for both cohorts is the proportion of eyes with a complete resolution of subfoveal fluid at 12 weeks post-treatment, assessed by optical coherence tomography. Secondary endpoints include changes in best-corrected visual acuity, central choroidal thickness, recurrence rates and incidence of adverse events over a 48 week follow-up.

Ethics and dissemination

The study protocol was approved by the Kyoto University Hospital Institutional Review Board, IRB of Chiba University Hospital, Tokyo Women’s Medical University Institutional Review Board and Institutional Review Board of Kansai Medical University Hospital. Written informed consent is obtained from all participants. The results will be disseminated through publication in a peer-reviewed journal and presentations at scientific conferences.

Trial registration number

jRCT2051230156 (URL: https://jrct.mhlw.go.jp/latest-detail/jRCT2051230156).

☐ ☆ ✇ BMJ Open

Use of wearable technology in improving emergency care and health outcomes for patients with urgent health complaints: protocol for a scoping review

Por: Alotaibi · R. · Alghaith · A. · Noehrer · L. H. · Kitchen · G. B. · Body · R. — Marzo 3rd 2026 at 13:40
Introduction

Since the 1970s, telemedicine has transformed significantly, becoming a critical component of modern healthcare delivery. Over time, technological innovation has increasingly emphasised the integration of the human body with digital systems to develop non-invasive methods for monitoring physiological parameters. Among these technologies, wearable sensors demonstrate substantial potential for continuous patient monitoring. These devices can facilitate real-time data collection, enable more rapid clinical decision-making and promote active patient participation in health management. Such capabilities are particularly valuable in emergency contexts, including prehospital care provided by ambulance services and telephone triage systems. Despite the growing interest in wearable health technologies, their integration into emergency medical services (EMS) remains insufficiently explored and warrants further investigation. We aim to map current research, explore the use of wearables in EMS settings and identify gaps in knowledge regarding their use in EMS.

Methods and analysis

This scoping review will follow the Joanna Briggs Institute’s (JBI) methodology for scoping reviews. A systematic search of relevant databases (MEDLINE, EMBASE, Cochrane Library, CINAHL, ProQuest and Web of Science) will be conducted, from inception to March 2026. All types of study designs, including quantitative and qualitative studies, will be considered in this scoping review. The inclusion is limited to studies published in English. Two independent reviewers (RA and AA) will conduct a thorough screening of titles and abstracts against the predefined inclusion criteria. Studies that meet the inclusion criteria will be reviewed in full text. Quality and risk of bias will be assessed using the JBI’s critical appraisal tools for the relevant study types. The findings will be presented using diagrams or tables, supplemented by narrative summaries following the JBI guidelines.

Ethics and dissemination

Ethical approval is not required. The findings of this study will be disseminated via publication in a peer-reviewed journal.

Registration

Open Science Framework (10.17605/OSF.IO/MUEFX).

☐ ☆ ✇ BMJ Open

Lack of association between the brain penetrance of calcium channel blockers and the incidence of neuropsychiatric outcomes: a retrospective, multidatabase cohort study

Por: Kern · D. M. · Bohn · J. · Maher · M. P. · Dymshyts · D. · Shoaibi · A. — Febrero 26th 2026 at 13:47
Objective

To use best practices in pharmacoepidemiology to assess the association between new use of brain-penetrant calcium channel blockers (BP-CCBs) compared with use of non-brain-penetrant CCBs (NP-CCBs) and the incidence of neuropsychiatric outcomes.

Design

Retrospective comparative cohort study.

Setting

Secondary data from nine claims and electronic health record databases from across the globe were used.

Participants

First use of a CCB was the index date. There were 1.2 million BP-CCB patients and 9.3 million NP-CCB patients identified across all databases, with 881 758 matched in each group.

Interventions

Patients were categorised as either initiating BP-CCBs or NP-CCBs. On-treatment and intention-to-treat analyses were conducted. Large-scale propensity models were used to match cohorts and control for observed confounding. Cox models were used to analyse the time to incident neuropsychiatric disorders. Negative control outcomes were used to calibrate estimates, CIs and p values to account for residual confounding. Diagnostics were used to assess the validity of the analysis.

Primary and secondary outcome measures

The time to first diagnosis of schizophrenia, schizoaffective disorder, major depressive disorder (MDD) and bipolar disorder was assessed independently. HRs compared the BP-CCB group to the NP-CCB group.

Results

For the outcome of incident MDD in the intention-to-treat design, the meta-analytic HR (95% CI) was 1.02 (0.97, 1.08). Meta-analytic HRs for bipolar disorder (1.04 (0.96, 1.13)), schizophrenia (1.05 (0.94, 1.18)) and schizoaffective disorder (1.04 (0.87, 1.23)) showed similar null effects. The on-treatment analysis was largely consistent: MDD (1.01 (0.96, 1.06)), bipolar (1.05 (0.86, 1.27)), schizophrenia (1.09 (0.87, 1.38)) and schizoaffective (1.00 (0.71, 1.40)).

Conclusions

There was no evidence of an association with any of the neuropsychiatric conditions of interest between use of BP-CCB and NP-CCB. This does not rule out the potential beneficial effect of CCB formulations and doses targeted specifically for the brain rather than the cardiovascular system.

☐ ☆ ✇ BMJ Open

ALARUM: Active One Health surveillance in LMICs to monitor and predict Antimicrobial Resistance Using Metagenomics - a cross-sectional study protocol

Por: van der Sande · M. A. B. · Valia · D. · Tigoi · C. · Stoesser · N. · Stamm · L. · Marten · A. · Riems · B. · Musyimi · R. · Sibidou · Y. · Schurch · A. C. · Tiendrebeogo · E. W. · Mwaringa · S. · Kohns Vasconcelos · M. · Ingelbeen · B. · Tinto · H. · Bielicki · J. A. · Cooper · B. S. · B — Febrero 24th 2026 at 16:52
Background

In rural sub-Saharan Africa (sSA), the burden of antimicrobial resistance (AMR) remains high. As AMR continues to rise, there is a strong need for practical, implementable surveillance to monitor and mitigate risks, as well as inform timely, evidence-based clinical decision-making. Emerging evidence points to possible community-level drivers, such as transmission between human, animal and environmental reservoirs as contributing factors, yet microbiological surveillance or opportunities for wastewater-based surveillance are often limited and insufficient in these settings. Therefore, alternative sustainable and affordable approaches are needed. We intend to build on the demonstrated potential of metagenomic profiling of pooled faecal material, which accurately predicted population-level AMR prevalence in invasive Enterobacterales infections.

Methods and analysis

We aim to validate this metagenomic pooled approach on additional populations, and to evaluate whether AMR patterns could be similarly predicted from surveillance of community One Health reservoirs. We will assemble existing data from hospital-based microbiology diagnostic laboratories in rural Burkina Faso and Kenya, and determine to what extent community-level metagenomic data, and/or faecal material of patients on hospital admission, can predict AMR in clinical isolates. We will perform community-level surveys in eight clusters per country, randomly selecting 15 households per cluster. We will systematically sample suspected environmental AMR exposure sites in and around households (soil, drinking water, latrines, chicken faeces) and collect data on community-level antibiotic use, hygiene practices, contact with domestic animals and sanitary facilities. Samples and data will be collected twice: during the dry and during the rainy season.

In addition to evaluating the accuracy of predicting resistance in clinical isolates, we will quantify community-level exposure risks. We will conduct metagenomic profiling on pooled DNA extracts from human stool samples (hospital and community-level) and from household environments. Bayesian statistical models will quantify relationships between AMR gene abundance in the environment and in human stool, and invasive bacteria identified among clinical patients, accounting for geography and seasonality. A cost-utility analysis will determine under what circumstances the use of pooled metagenomic data to inform empirical antibiotic policies would represent an efficient use of resources.

Ethics and dissemination

The proposed surveillance protocol is developed in partnership with local communities and local and international researchers and has received ethical approval in Kenya and Burkina Faso. It will assess whether intermittent, pooled-sample metagenomics provides a viable, low-cost and practical approach for population-level AMR surveillance in settings that—like many in rural sSA—lack systematic microbiological diagnostics and where sewage systems for wastewater-based surveillance are absent. By providing an alternative to routine microbiological-based surveillance where this proves challenging to implement, this approach may help improve treatment outcomes, contribute to equity and public health. Findings will be disseminated through peer-reviewed publications and academic conferences and will contribute to the recently proposed WHO AMR surveillance strategy, which combines survey-based approaches with routine AMR surveillance.

☐ ☆ ✇ BMJ Open

Stakeholders perspectives on implementation of a clean fuel: clean stove intervention for reduction of household air pollution and hypertension in Lagos, Nigeria - a qualitative study

Por: Onakomaiya · D. O. · Mishra · S. · Colvin · C. · Ogunyemi · R. · Aderibigbe · A. A. · Fagbemi · T. · Adeniji · M. R. · Li · S. · Kanneh · N. · Aifah · A. · Vedanthan · R. · Olopade · C. O. · Wright · K. · Ogedegbe · G. · Wall · S. P. — Enero 9th 2026 at 14:17
Objectives

To identify stakeholder perceived challenges and facilitators for implementing a clean fuel and clean stove intervention to reduce household air pollution and hypertension in Lagos, Nigeria.

Design

Qualitative study guided by the Exploration and Preparation phases of the Exploration, Preparation, Implementation, and Sustainment (EPIS) framework, using focus group discussions and in-depth semi-structured interviews with inductive and deductive thematic analysis.

Setting

Peri-urban communities across the five administrative divisions of Lagos State, Nigeria.

Participants

128 stakeholders from 32 communities, including community, religious, market and youth leaders, primary healthcare staff, and household decision makers. Approximately half were female.

Interventions

This was a pre-implementation needs assessment that included demonstrations of the clean stove and fuel.

Primary and secondary outcome measures

Thematic domains describing barriers and enablers to adoption and implementation, mapped to EPIS inner, outer, and bridging factors.

Results

Stakeholders reported barriers that included stove stacking, upfront stove cost, concerns about long-term fuel price and availability, equipment durability and maintenance, safety, mistrust of new technology, and uncertainty about stove performance for dishes requiring high heat and long cooking times. Reported facilitators included payment flexibility and subsidies, opportunities to test the stove, perceived benefits of cleaner and faster cooking with less soot, endorsement by community leaders, and interest in local retail and distribution to improve access.

Conclusions

Implementation planning for clean fuel and clean stove programmes should address affordability, reliable fuel supply chains, durability and service, culturally relevant cooking needs, and trust building through community leadership. These findings inform adaptation strategies for scale-up in similar low-resource settings.

Trial registration number

NCT05048147.

☐ ☆ ✇ BMJ Open

Mentorship-infused initiatives for postgraduate research supervision in African higher institutions of learning: a systematic review and meta-synthesis protocol

Por: Oladimeji · O. · Londani · M. · Moyo · S. · Seekoe · E. · Saidi · A. · Mothiba · T. M. · Feza · N. N. · Davhana-Maselesele · M. · Maart · R. · Babalola · J. O. · Okoh · A. I. · Okonofua · F. · Ntusi · N. A. B. · Sibiya · M. N. — Enero 5th 2026 at 12:39
Introduction

Strengthening research capacity in Africa is vital for tackling pressing health, educational and socioeconomic challenges facing the continent. At the core of this effort is the cultivation of innovative research leaders through postgraduate training programmes that incorporate mentorship-infused supervision. Such models have demonstrated potential in improving research skills, boosting academic productivity and fostering leadership development among emerging scholars. This systematic review and meta-synthesis protocol aims to examine existing mentorship-infused supervision practices across African higher education institutions. The review seeks to identify effective models, uncover common challenges and barriers, and generate evidence-based recommendations to develop sustainable, contextually relevant strategies. Insights from this work will inform policies and practices to enhance postgraduate research training, advance research leadership and contribute to the broader goal of strengthening research ecosystems across Africa.

Methods and analysis

A systematic review and thematic meta-synthesis will be undertaken, focusing on qualitative research studies as well as the qualitative components of mixed-methods studies. Relevant studies published in English will be identified through a comprehensive search strategy. The electronic databases, including Medline/PubMed, Scopus, Web of Science, African Journals Online, EMBASE and CINAHL, will be searched to capture a wide range of peer-reviewed articles and grey literature. Databases will be searched from March 2026. Two reviewers will independently perform study selection, data extraction, quality assessment and evaluation of risk of bias, using the Critical Appraisal Skills Programme checklist.

Ethics and dissemination

This systematic review and meta-synthesis will analyse publicly available literature and does not require ethical approval, as it involves no primary data collection. It will adhere to established ethical and methodological standards, including proper citation and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The findings will be widely disseminated through open-access journal publication, conference presentations and targeted reports for universities, research institutions and policymakers to inform and support mentorship-based postgraduate research supervision across Africa.

PROSPERO registration number

CDR420251049878. Available from https://www.crd.york.ac.uk/PROSPERO/view/CRD420251049878.

☐ ☆ ✇ BMJ Open

Obinutuzumab versus Rituximab to maintain remission in children with steroid-dependent and frequently relapsing nephrotic syndrome: the OBIRINS study protocol, a double-blind randomised controlled trial

Por: Dossier · C. · Sellier-Leclerc · A.-L. · Simon · T. · Parmentier · C. · Boyer · O. · Samaille · C. · Fila · M. · Roussey-Kesler · G. · Magnavacca · M. · Chartier · Y. · Louillet · F. · Zaloszyc · A. · Vrillon · I. · Elaribi · D. · Bouatia · S. · Kaguelidou · F. · Guilmin-Crepon · S. · Ho — Diciembre 25th 2025 at 05:45
Introduction

There is an unmet clinical need for the development of novel treatment strategies to improve the outcome of children with frequent relapsing or steroid-dependent nephrotic syndrome. Obinutuzumab (OBI) is a second-generation anti-CD20 monoclonal antibody that has demonstrated its superiority to rituximab (RTX) in vitro and in vivo. Our assumption is that a single infusion of low-dose OBI will induce longer B-cell depletion, longer sustained remission and reduce the frequency of relapses and the use of oral immunosuppressors compared with a single infusion of RTX.

Methods and analysis

We conduct a double-blind, multicentre, randomised, parallel group in a 1:1 ratio controlled trial. In the experimental group, patients receive 1 infusion of OBI (300 mg/1.73 m2) and in the control group, the patients receive 1 infusion of RTX (375 mg/m2). The primary outcome of the study is the occurrence of the first relapse within 12 months following the initiation of treatment and secondary outcomes include the time to first relapse, the total number of relapses during the 24-month follow-up period, and any adverse events such as infusion-related complications, infectious complications, hypogammaglobulinaemia and neutropenia.

Ethics and dissemination

The study has been approved by the ethics committee (Comité de Protection des Personnes) of Sud Méditerrannée 2 and authorised by the French drug regulatory agency (Agence Nationale de Sécurité du Médicament et des Produits de Santé). Results of the primary study and the secondary aims will be disseminated through peer-reviewed publications.

Trial registration number

NCT05786768.

Eudract N°

2022-003336-59.

☐ ☆ ✇ BMJ Open

Psychosocial adjustment in patients with diabetic retinopathy in northeastern Iran: a qualitative study based on the transactional stress theory

Por: Salehnezhad · A.-S. · Sedghi · F. · Mahdizadeh · M. · Jamali · J. · Shoeibi · N. · Vahedian-Shahroodi · M. — Noviembre 27th 2025 at 03:23
Objectives

This study aimed to explore the psychosocial adaptation processes and coping methods among patients with diabetic retinopathy (DR), emphasising the importance of understanding their lived experiences.

Design

A qualitative study using semi-structured interviews.

Setting

A tertiary eye hospital in northeastern Iran.

Participants

The participants comprised patients with DR, their families and healthcare professionals.

Methods

Qualitative data were analysed based on transactional stress theory using deductive thematic analysis to identify psychosocial adaptation concepts.

Results

65% of participating patients had DR for more than 5 years. Analysis of 49 patient and 14 healthcare professional interviews revealed 6 key themes encompassing 15 categories and 33 subcategories: primary appraisal (threat perception, motivational assessment, self-blame), secondary appraisal (perceived control over disease outcomes, perceived control over emotions, self-efficacy), coping efforts (problem management, emotional regulation), meaning-based coping (positive reassessment, reinforcement of religious beliefs, constructive approach), moderators (seeking information, all-encompassing assistance) and adaptation (emotional health, individual-social functioning).

Conclusions

The analysis revealed that deficits in disease awareness, financial and systemic barriers and emotional distress significantly impeded adaptive coping. Conversely, self-efficacy, social and organisational support, and meaning-based coping strategies were key facilitators. Our findings suggest that facilitating positive psychosocial adjustment in patients with DR may require interventions that address these specific barriers and leverage these facilitators, such as providing comprehensive disease knowledge and constructing robust support systems. This study highlights the potential value of a holistic care approach that integrates medical treatment, targeted patient education and psychological support to improve the overall quality of life for these patients.

☐ ☆ ✇ 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

Understanding and reframing clinical errors through just culture: protocol for the DECIDE mixed-methods study in Spanish healthcare and community contexts

Por: Mira · J. J. · Lorenzo · S. · Aranaz-Andres · J. M. · Macias-Maroto · M. · Cobos-Vargas · A. · Moreno Campoy · E. E. · Perez-Perez · P. · Trillo-Lopez · P. · Corpas-Nogales · E. · Gea Velazquez de Castro · M. T. · Arencibia-Jimenez · M. · Asencio · A. · Diez Herrero · D. · Molina — Octubre 21st 2025 at 08:30
Introduction

Patient safety culture plays a crucial role in reducing clinical errors. By improving healthcare professionals’ and patients’ understanding of human fallibility and error attribution, patient care can be enhanced, fostering greater engagement from both groups. A Just Culture approach, which balances accountability and learning from errors, is a key factor in fostering this safety culture. The DECIDE Project aims to: (1) examine the conceptualisation of human fallibility within and beyond healthcare, (2) identify barriers and facilitators to Just Culture adoption, (3) assess the impact of psychoeducational interventions on professionals’ and social leaders’ attitudes toward clinical errors and (4) develop a roadmap for Just Culture implementation in healthcare.

Methods and analysis

A 36-month mixed-methods study including qualitative research, a survey of 1255 healthcare professionals, an experimental study with 180 participants (60 per arm) testing interventions based on cognitive dissonance and reasoned action theories and a consensus conference to develop a Just Culture roadmap. Participants include professionals from hospitals, primary care, long-term care, nursing homes and social leaders in Spain. The qualitative data collected during stages 1 and 4 will be analysed using MAXQDA software. In identifying factors related to the implementation of Just Culture during stage 2, ANOVA, t-tests and multiple linear regression will be conducted. To examine the effects of the interventions in phase 3, a linear mixed-effects model for repeated measures will be employed.

Ethics and dissemination

This study has received ethical approval from three institutional review boards. Findings will be disseminated through peer-reviewed publications, conference presentations and policy recommendations aimed at integrating Just Culture into national and international patient safety strategies. By promoting a constructive approach to errors, the project could enhance incident reporting, strengthen professional engagement in safety policies and foster a culture of learning and accountability. Its findings will guide policy recommendations for integrating Just Culture into national and international patient safety strategies, with potential applications beyond Spain.

ClinicalTrials.gov identifier

NCT06835517.

☐ ☆ ✇ BMJ Open

Prepectoral no mesh versus mesh immediate implant-based reconstruction after mastectomy (Restore-B): a multicentre single-blinded randomised controlled feasibility study protocol

Por: Rolph · R. · Ziebland · S. · Cook · J. A. · Iglesias · C. · Wakefield-Scurr · J. · Malyon · C. · Scaife · J. · Taylor · A. · Hennessy · A. · Markham · S. · Bernstein · M. · Douek · M. · Restore-B Feasibility Collaborative Group · Roy · Rusby · Bonomi · St-John · Agrawal · Smith · Beta — Octubre 17th 2025 at 11:49
Introduction

Breast cancer is common and women requiring mastectomy will be offered a breast reconstruction if they are surgically suitable candidate. Breast reconstruction can be performed at the same time as the mastectomy (immediate) or delayed to a second operation after cancer treatments. The reconstruction can either use the patients’ own tissue to make the breast (autologous) or use a prosthesis to make the breast in the form of a fixed or expandable volume implant (implant-based breast reconstruction, IBBR). Immediate breast reconstruction on top of the chest wall muscles (prepectoral) is performed worldwide. This operation involves the use of a synthetic or biological mesh placed around the implant under the skin. Increasingly, surgeons are performing this technique without the use of mesh. Both techniques, with and without mesh, have not been compared in a head-to-head randomised controlled trial (RCT); therefore, surgeons and patients do not have high quality data to guide their decision making in this area.

Methods and analysis

UK-based pragmatic multicentre randomised controlled feasibility trial. The primary aim is to determine the feasibility of a definitive RCT comparing the clinical and cost-effectiveness of no-mesh versus mesh-assisted prepectoral breast reconstruction. Secondary objectives will explore patient understanding of mesh and willingness to be randomised within an RCT; determine if it is possible to collect data to inform a future economic analysis on the use of mesh in breast reconstruction and determine the feasibility of measuring breast biomechanics pre-surgery and post breast reconstruction surgery. Total number of patients to be included: 40 (20 per arm).

Ethics and dissemination

This study will be conducted in compliance with the Declaration of Helsinki. Ethical approval has been obtained. Ethics Ref: 23/SC/0302; IRAS Project ID: 301 423. The results of this study will be published in a peer-reviewed medical journal, independent of the results, following the Consolidated Standards of Reporting Trials standards for RCTs.

Trial registration numbers

NCT06112977; ISRCTN17470747.

☐ ☆ ✇ BMJ Open

Determinants of vaccine hesitancy among pregnant women in South-West Nigeria: an explanatory sequential mixed method design

Por: Ogundele · O. A. · Omoloja · O. · Zibiri · A. O. · Dinehin · A. V. · Adewusi · A. O. · Nwabueze · J. — Octubre 3rd 2025 at 06:32
Objective

This study aimed to assess the prevalence and determinants of vaccine hesitancy among pregnant women in South-West Nigeria.

Design

An explanatory sequential mixed-methods study was conducted between January and March 2023. Participants for the quantitative phase were selected using a systematic sampling technique, while those for the qualitative phase were purposively selected. A modified parent attitude about childhood vaccines questionnaire was used for data collection and analysed using IBM SPSS V.25.0. Qualitative data were collected through focus group discussions and analysed using NVivo V.14. Univariable, bivariable and multivariable logistic regression analysis was done. A p

Setting

A tertiary health facility in South-West Nigeria.

Participants

Three hundred and forty-five pregnant women participated in the quantitative phase, while 24 pregnant women were involved in the qualitative phase.

Results

The overall prevalence of vaccine hesitancy was 32%. Based on the domains, only 15.4% of the respondents were hesitant due to vaccination behaviour, 38.6% for safety and efficacy, and 49.6% were hesitant due to general attitude and trust for healthcare providers. Maternal age, number of children, religion and occupation showed significant association with vaccine hesitancy. Regarding the predictors of vaccine hesitancy, employed pregnant women (adjusted OR (aOR), 4.33; 95% CI: 1.60 to 9.70) and younger pregnant women (aOR, 2.53; 95% CI: 1.04 to 7.70) had a significantly higher odds of being vaccine-hesitant. The qualitative analyses revealed several major themes that contributed to vaccine hesitancy, including concerns about vaccine safety and efficacy, distrust of healthcare providers and the government, and the spread of misinformation through social networks and peers.

Conclusion

A significant proportion of pregnant women in this study were vaccine-hesitant. The major reasons for vaccine hesitancy are concerns about the safety of vaccines and lack of trust for healthcare providers. Policies and programmes should be aimed at improving vaccination behaviour, addressing safety concerns and building trust in vaccination systems.

☐ ☆ ✇ BMJ Open

Tailored exercise management versus usual care for people aged 80 years or older with hip/knee osteoarthritis and comorbidities (TEMPO): multicentre feasibility randomised controlled trial in England

Por: Nicolson · P. J. A. · Holden · M. A. · Marian · I. · Saeedi · E. · Williamson · E. · Moylan · D. · Stone · M. · Hopewell · S. · Lamb · S. E. · TEMPO feasibility trial collaborators · Barker · Dickson · Price · Webber — Septiembre 23rd 2025 at 03:05
Objective

To assess the feasibility of conducting a definitive randomised controlled trial (RCT) to test the clinical and cost-effectiveness of a tailored exercise intervention compared with usual care for people aged 80 years and older with hip and/or knee osteoarthritis (OA) and comorbidities.

Design

Two-arm, parallel-design, multicentre, pragmatic, feasibility RCT.

Setting

Four National Health Service outpatient physiotherapy services across England.

Participants

Adults aged 80 years and over with clinical hip and/or knee OA and ≥1 comorbidity.

Interventions

Participants were randomised 1:1 via a central web-based system to be offered: (1) a 12-week tailored exercise programme or (2) usual care. Participants and outcome assessors were not blinded to treatment allocation.

Feasibility objectives

(1) Ability to screen and recruit participants; (2) retention of participants at 14-week follow-up; (3) intervention fidelity (proportion of participants who received ≥4 intervention sessions as per protocol) and (4) participant engagement (assessed by home exercise adherence).

Results

Between 12 May 2022 and 26 January 2023, 133 potential participants were screened, of whom 94 were eligible. The main reasons for ineligibility were symptoms not consistent with hip or knee OA (10/39, 25.6%) or already having had a physiotherapy appointment (8/39, 20.5%). 51 of 94 (54%) eligible participants were recruited. Participants had a mean age of 84 years (SD 3.5), 31 (60.8%) were female and 96.1% reported their ethnicity as White British (n=49/51). 45 of 51 participants (88%) provided outcome data at the 14-week follow-up time point. Four or more intervention sessions were attended by 13/25 (52%) participants. Home exercise log completion declined over time: 6/23 participants (26.1%) returned completed exercise logs for all 12 weeks. The median number of days home exercises were recorded each week was 5 (range 0–7).

Conclusions

This study demonstrated that a definitive trial would be feasible. Before proceeding, modifications to ensure recruitment of a diverse population and intervention fidelity should be addressed.

Trial registration number

ISRCTN75983430.

☐ ☆ ✇ BMJ Open

High flow oxygen for vaso-occlusive crisis: a multicentre, prospective, randomised, multi-arm, multi-stage clinical trial (OSONE)

Por: Mekontso Dessap · A. · Habibi · A. · Guillaud · C. · Kassasseya · C. · Larrat · C. · Agbakou · M. · Tchoubou · T. · Candille · C. · Carpentier · B. · Landais · M. · Arlet · J.-B. · Fartoukh · M. · Desclaux · A. · Masseau · A. · Oziel · J. · Bouharaoua · S. · Affo · C. · Viglino · D. · Bouk — Septiembre 18th 2025 at 03:51
Introduction

Sickle cell disease (SCD) is due to the mutation of haemoglobin (Hb), from HbA to HbS and characterised by recurrent vaso-occlusive crises (VOC), which can progress to acute chest syndrome (ACS), a leading cause of death in adults with SCD. Hypoxia is a key modifiable factor in the polymerisation of HbS and the pathogenesis of VOC. High-flow nasal oxygen (HFNO) delivers humidified gas at high oxygen concentrations and flow rates: the former may reverse sickling (metabolic effect) to accelerate VOC resolution and prevent ACS, while the latter may reduce the risk of ACS by mitigating hypercapnia and generating positive airway pressure that limits hypoventilation and atelectasis (pulmonary effect). The study hypothesises that HFNO is a safe and effective strategy for treating VOC and preventing secondary ACS, and will assess this using a multi-arm multi-stage (MAMS) trial design.

Methods and analysis

This is a prospective, multicentre, randomised, open-label controlled trial following an MAMS design with three phases and four arms: one control (low-flow oxygen) and three HFNO intervention arms with varying fraction of inspired oxygen levels (low, intermediate, high). The pilot stage will assess safety and feasibility, using the rate of cardiac and neurological events as the primary endpoint. In the activity stage, arms demonstrating acceptable safety will be compared for efficacy based on the rate of VOC resolution without complications by day 5, allowing selection of the most promising arm. The final efficacy stage will compare the selected HFNO strategy to control, with prevention of secondary ACS by day 14 as the primary endpoint. The study aims to enrol up to 350 VOC episodes in total.

Ethics and dissemination

The study has been granted ethical approval (CPP SUD MEDITERRANEE IV). Following the provision of informed consent, patients will be included in the study. The results will be submitted for publication in peer-reviewed journals.

Trial registration number

NCT03976180.

☐ ☆ ✇ BMJ Open

Challenges of cancer survivorship care in Chile: a longitudinal study comparing the quality of care and quality of life for cancer survivors in a primary care network and a cancer centre in Chile

Por: Puschel · K. · Arancibia · V. · Rioseco · A. · Paz · S. · Soto · M. G. · Martinez · J. · Faundez · M. · Acevedo · F. · Di Biase · F. · Emery · J. · Leon · A. · Are · C. · Thompson · B. — Agosto 11th 2025 at 03:13
Objective

The rapid growth in the cancer survivor population in Chile and Latin America raises new challenges in addressing their care needs. This study assesses the health status and compares the quality of care and quality of life in cancer survivors at a primary care network and a private cancer centre in Santiago, Chile.

Design

Retrospective cohort study.

Setting

Three primary care clinics and one cancer centre in Chile.

Participants

All breast and colorectal cancer patients identified from a primary care retrospective cohort of 61 174 were followed from 2018 to 2023 and compared with an equivalent sample of patients from a university cancer centre identified during the same period.

Outcome measures

Quality of care was assessed based on American Cancer Society standards, while quality of life was measured using the EuroQol 5 Dimensions-5 Levels survey instrument.

Results

A total of 420 cancer survivors participated in the study; 208 from primary care and 212 from the cancer centre. All participants received substandard care. Patients in primary care had lower educational levels and higher rates of comorbidity. They reported a lower quality of life score (72.22 vs 78.43, p

Conclusion

Cancer survivors face a significant disease burden and receive substandard care in Chile. As the primary source of care for this population, primary care is challenged to better integrate with speciality care to develop an effective shared care model for cancer survivors.

☐ ☆ ✇ BMJ Open

New generation of paediatricians in the health care system: are paediatric residents ready to manage children without supervision? A survey using respiratory infections as a model

Por: Del Bene · M. · Diana · A. · Corsello · A. · Cecere · F. · Indolfi · C. · Mozzillo · E. · Nunziata · F. · Pascarella · F. · Rossi · F. · Sibilio · M. · Ummarino · M. · Guarino · A. — Julio 25th 2025 at 10:04
Objectives

To measure the perceived autonomy level in managing lower respiratory tract infections (LRTIs) among paediatric residents and to compare perceived autonomy with the assessments by tutors who directly supervise and evaluate residents

Design/setting

A survey on managing LRTIs was distributed among all Italian paediatric residents and tutors via Google Forms between January 1 and 31, 2024.

Participants, residents and tutors were classified according to their training year and clinical setting: primary care paediatrics (PCP), emergency department (ED) and hospital ward (HW).

Outcome

Perceived autonomy of paediatric residents in managing LRTI in different settings; overall perceived autonomy and interest in employment.

Results

A total of 391 questionnaires were returned, with 273 completed by residents and 118 by tutors. Among residents, 3% in their first year felt fully capable of managing LRTIs without supervision in both ED and HW settings. This percentage remained below 25% until the third year and increased to 72% in ED and 83% in HW by the fifth year. In PCP settings, autonomy ranged from 15% in the first year to 96% in the final year. No differences were found between residents’ self-evaluations and tutors’ assessments. Confidence in skills showed no regional differences across Italy.

Conclusion

Most residents did not feel ready to manage winter respiratory infections in children without supervision, especially in the ED compared with the HW; however, self-confidence was higher in the PCP setting. Tutors shared similar perceptions. The location did not affect the response pattern. These findings caution against employing residents to work autonomously, particularly in emergency settings.

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