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.

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.

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.

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

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.

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.

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

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

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.

Retrospective comparative cohort study.

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

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.

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.

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.

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)).

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.

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.

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.

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.

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.

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.

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

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

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

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

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.

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.

NCT05048147.

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.

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.

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.

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

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.

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.

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.

NCT05786768.

2022-003336-59.

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.

A qualitative study using semi-structured interviews.

A tertiary eye hospital in northeastern Iran.

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

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

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).

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.

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

Cross-sectional study.

Three hospitals in Eastern Ethiopia.

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%).

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

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

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.

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.

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.

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.

NCT06835517.