Patients receiving haemodialysis are at very high risk of fragility fracture, yet there are no proven treatments for fracture prevention. We will advance a pilot study on the feasibility of a large, pragmatic, randomised controlled trial (RCT) of denosumab for fragility fracture prevention in haemodialysis.

PRevEnting FracturEs in REnal Disease-1 is a pragmatic, open-label, pilot study of an RCT of a denosumab care pathway embedded in routine care haemodialysis centres.

We will recruit at least 60 participants at high risk of fracture from at least 6 haemodialysis centres in Ontario, Canada. They must be aged 40 years or older, have access to provincial drug coverage, have appropriate baseline calcium and parathyroid hormone levels and be deemed suitable for denosumab by their kidney care provider. Participants will be randomised 1:1 to denosumab (with supports to mitigate hypocalcaemia) versus usual care using block randomisation by a central statistician (computer-generated sequence). Primary outcomes include recruitment feasibility and adherence. Secondary outcomes include safety (hypocalcaemia) and participant satisfaction with our protocol and processes. Study investigators and data analysts will be blind to treatment allocation.

We will present results descriptively. The trial was approved by Clinical Trials Ontario and local research ethics boards across study sites.

Primary and secondary outcomes will be published on trial completion.

This pilot will inform the feasibility of conducting a large-scale, efficiently run, pragmatic RCT to test whether a denosumab care pathway safely reduces the risk of fragility fracture in patients receiving haemodialysis. Results have the potential to transform fracture care in real-world patients with kidney and metabolic bone disease.

NCT05096195.

Nipah virus (NiV) is a bat-transmitted paramyxovirus causing recurrent, high-mortality outbreaks in South and South-East Asia. As a WHO priority pathogen, efforts are underway to develop therapies like monoclonal antibodies and small-molecule antivirals, which require evaluation in clinical trials. However, trial design is challenging due to limited understanding of NiV’s clinical characteristics. Given the rarity of NiV infections, strategies targeting improved outcomes for the broader acute encephalitis syndrome (AES) patient population, including those with NiV, are essential for advancing therapeutic research. To address these gaps, we designed the Bangladesh AES cohort study to characterise the patient population, clinical features, treatment practices, common aetiologies and outcomes in patients presenting with AES, including NiV infection, as a clinical characterisation study to inform the design of clinical trials for NiV and AES more broadly.

This prospective cohort study will be conducted in Bangladesh, a NiV endemic country with annual outbreaks. In collaboration with the ongoing NiV surveillance programme in Bangladesh, we aim to enrol up to 2000 patients of all ages presenting with AES at three tertiary care hospitals within the Nipah belt. Patients who provide informed consent to participate will be monitored throughout their hospital stay until 90 days post enrolment. Data will be systematically collected through interviews and medical record reviews at several time points: on the day of enrolment, day 3, day 7, the day of critical care admission (if applicable), discharge day and 90 days post enrollment. Additionally, a portion of the cerebrospinal fluid collected under the concurrent NiV surveillance protocol will be tested for an array of viral and bacterial pathogens responsible for encephalitis at the International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b) laboratory.

The study received ethical approval from the Oxford Tropical Research Ethics Committee, University of Oxford, UK (OxTREC Ref: 576–23) and the institutional review board of icddr,b, Bangladesh (icddr,b protocol number: 24016). By characterising the AES patient population, this study will generate essential evidence on key clinical parameters, which will be pivotal in optimising the design of clinical trials for potential interventions aimed at improving outcomes in patients with AES, including those with NiV disease. Findings will be shared with participating hospitals, patients and relevant government stakeholders. Results will also be disseminated through conference presentations and peer-reviewed publications.

Not applicable (this is an observational study).

Maternal and child health remains a critical public health challenge in developing countries. Annually, an estimated 250 000–280 000 maternal deaths occur, with up to 95% attributed to inadequate access to timely, effective and quality healthcare. While digital health interventions have demonstrated significant potential in improving maternal health services, education and support in high-income settings, their effectiveness, feasibility and broader impact in resource-limited contexts remain understudied.

This systematic review will assess the effectiveness, feasibility and impact of digital health interventions for pregnant women and new mothers in resource-limited settings across developing countries. We will conduct a comprehensive search of MEDLINE (via PubMed), Embase, Scopus, Google Scholar and grey literature sources to identify randomised controlled trials, quasi-experimental studies and observational studies published in any language. The quality of included studies will be assessed using the Cochrane‘s risk of bias tools, RoB 2 for randomised trials and the ROBINS-I tool for non-randomised studies. A standardised data extraction form will be developed, piloted and used to systematically collect study data. We will employ the web-based CADIMA platform to facilitate screening, data extraction and evidence synthesis while minimising bias. Data will be synthesised narratively by summarising study characteristics and, where appropriate, through meta-analysis using random-effects models to calculate pooled effect sizes. Finally, we will evaluate the strength of the evidence for each outcome using the Grading of Recommendations Assessment, Development and Evaluation approach to assess confidence in the findings.

No ethical approval was required for this systematic review, as it uses only previously published data. The findings will be submitted for publication in a peer-reviewed journal and presented at relevant international conferences to disseminate them to the broader academic community. To ensure practical application of our results, we will develop a policy brief summarising key findings and recommendations.

This protocol is registered to PROSPERO, and the registration number is CRD42025631164.

Alzheimer’s disease (AD) impacts over 55 million individuals worldwide and remains the leading cause of dementia (60–70% of cases). By 2050, South and Southeast Asia are projected to have an older adult population more than double, bearing a major share of Alzheimer’s disease burden. This will exert a heavy strain on healthcare systems, particularly in resource-limited countries where support and infrastructure are already stretched. Despite this, no review has yet explored the regional epidemiology and associated risk factors in this context. Thus, this study protocol outlines to synthesise prevailing evidence from these densely populated regions, particularly low- and middle-income nations within South and Southeast Asia.

This review will include studies that reported epidemiological characteristics including prevalence, age of onset, mortality, and risk factors of AD and related dementias comprising in South and Southeast Asian regions. Studies published in any language from inception to date will be extracted from PubMed, Scopus, CINAHL, EMBASE and APA PsycNet, following Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) and Meta-Analysis of Observational Studies in Epidemiology (MOOSE) guidelines. We will also search grey literature sources and screen the reference lists of the articles selected for full-text review to identify additional relevant studies. Observational studies including case–control, cohort, and cross-sectional designs reporting desired outcomes will be included and appraised for quality assessment with the modified Newcastle-Ottawa Scale (mNOS). The included articles will be appraised by two independent reviewers, with a third resolving any conflicts. Pooled estimates of prevalence, age of onset and mortality will be analysed using random effect meta-analysis (REML) model. Associated risk factors, including modifiable and non-modifiable will be narratively synthesised. Forest plots will be used to visualise the findings, and heterogeneity across the included studies will be assessed using the I² and Cochrane’s Q statistics. Potential publication bias will be assessed using a funnel plot along with the Begg’s and Egger’s tests. Sensitivity and subgroup analyses will also be conducted to assess the robustness of pooled estimates and to explore potential sources of heterogeneity. Statistical analysis will be conducted using Rstudio (v.4.3.2) and GraphPad Prism V.9.0.2.

The systematic review is focused on the analysis of secondary data from published literature; thus, no ethical approval will be needed. The protocol will follow international standard guidelines, findings will be reported in a reputed journal and disseminated through (inter)national conferences, webinars and key stakeholders to inform policy, research and AD management strategies.

CRD 420251047105.

Depression, affecting 350 million people globally, is notably prevalent among medical students, particularly in South Asia, including Bangladesh. Despite several studies, no meta-analysis has systematically examined the prevalence and contributing factors of depression to address the mental health burden. This systematic review and meta-analysis protocol aims to consolidate findings on the regional prevalence and key risk factors among Bangladeshi medical students.

The research team will search the Medline (Pubmed), Scopus, Web of science, Embase, PsycInfo, BanglaJOL and Google Scholar electronic databases following the Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) guidelines for published studies from their inception till 1^St March 2025, using truncated and phrase-searched keywords and relevant Medical Subject Headings (MeSHs). Observational studies, including cross-sectional, cohort and case-control studies published within the timeframe and following any validated depression assessment tools, with no language restriction, reporting bangladeshi medical students, will be included for the review. Review papers, intervention studies, commentaries, preprints, meeting abstracts, protocols, unpublished studies and letters will be excluded. Two independent reviewers (SS, IA) will screen the retrieved papers using Rayyan, a web-based application, while any disagreements between them will be resolved by a third reviewer (ATS). Exposure will refer to different factors associated with depression among Bangladeshi medical students. Prevalence of depression and associated factors will be extracted. Narrative synthesis (Qualitative information) and meta-analysis (Quantitative data) will be conducted to assess the pooled prevalence using the random-effects meta-analysis (REML) model. For enhanced visualisation of the included studies, forest and funnel plots will be constructed. Heterogeneity among the studies will be assessed using the I ² statistic, sensitivity,and subgroup analyses will be conducted, if necessary, based on study heterogeneity. The quality of the included studies will be assessed using the modified Newcastle-Ottawa Scale (mNOS) tool developed for observational study designs. All statistical analyses and visualization will be conducted using the R studio v.4.3.2 with built-in "meta"-packages and GraphPad Prism v.9.0.2.

This review will analyse existing published evidence. Findings will be submitted to a peer-reviewed journal and disseminated through conferences, policy forums and stakeholders to guide future research and interventions.

CRD 420251006480.

The hospital-at-home (HaH) model has gained traction as a viable alternative to traditional inpatient care, allowing patients to receive care in their own homes. Despite its growing popularity, there is a lack of comprehensive research addressing effectiveness, safety and factors critical to the successful implementation of HaH programmes. We conducted a scoping review to comprehensively map and summarise the evidence on both admission avoidance and early-supported discharge up until now.

A scoping review of randomised controlled trials (RCTs), conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis: extension for Scoping Reviews (PRISMA-ScR) guidelines.

Ovid MEDLINE, Embase, CINAHL and Web of Science were systematically searched up to July 2024

We included English-language RCTs published from 2005 onwards, involving adults (≥18 years) receiving acute care at home who would otherwise require hospital admission. Eligible studies evaluated admission avoidance or early supported discharge within HaH settings for acutely ill patients. Studies focusing on outpatient care, non-acute conditions or interventions not aligning with the widely accepted HaH definition were excluded. COVID-19-related studies were also excluded to avoid context-specific bias.

Two reviewers independently extracted data on study characteristics, interventions and outcomes including mortality, length of stay, escalation rates, costs and patient and caregiver satisfaction. Implementation facilitators and barriers were also collected. Discrepancies were resolved by a third reviewer. Results were synthesised descriptively in accordance with PRISMA-ScR guidelines.

Nine RCTs were identified. The review shows that the HaH model is at least as safe as usual care, with lower or comparable mortality rates. Length of stay varied, with some studies reporting longer stays in the HaH group due to cautious clinical practices. Cost analyses often indicate lower healthcare costs with staffing as the largest expense. Patient and caregiver satisfaction was high, but essential implementation factors were not clearly addressed.

The HaH model represents a promising alternative to acute inpatient care for suitable patients. Future research should focus on conducting larger RCTs, expanding the range of conditions suitable for HaH. Despite favourable clinical outcomes, substantial implementation barriers remain underexplored in current RCTs. This underscores the need to identify strategies for successful implementation, including the integration of technological advancements and qualitative insights into patient and caregiver experiences.

Caesarean birth (CB) under neuraxial anaesthesia (NA) is the most performed inpatient operation in the UK. The incidence of intraoperative pain during caesarean delivery performed under neuraxial anaesthesia is unclear, with limited data that used patient-reported measures to investigate intraoperative pain. The short- and medium-term impacts on patients of this adverse event are unknown.

We will undertake a multicentre, prospective observational cohort study to evaluate the incidence and impact of pain experienced by patients during CB performed under neuraxial anaesthesia. Routine audit data will be collected for all patients undergoing caesarean delivery for any indication during a 1 week window at participating hospitals within the UK and Queensland, Australia. The dataset will include patient, anaesthetic, obstetric and neonatal risk factors for intraoperative pain. Local investigators will then seek informed consent from patients either before or within 24 hours of delivery to record patient experience and patient-reported outcomes at 24 hours and 6 weeks postdelivery. Local investigators at participating hospitals will also complete a survey evaluating compliance with evidence-based structural standards at their sites. The patient characteristics, structures, processes and outcomes will be described. Inferential techniques will be used to evaluate the relationship between risk factors and postoperative outcomes.

This study received ethical approval from the Leicester Health Research Authority and Care Research Wales, REC reference 24/EM/0084) on 24 May 24. The study received ethical approval from the Human Research Ethics Committee of Metro North Health in Australia on 25 March 2024 (REC Ref HREC/2024/MNHA/103767). The results of the study will be reported in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology statement. The results will be disseminated via conference presentations, peer-reviewed academic journals and reports prepared for patients, the public and policy makers.

ISRCTN15269213.