About 30% of depressed patients suffer from a protracted course in which the disorder continues to cause significant burden despite treatment efforts. While originally developed for relapse prevention, mindfulness-based cognitive therapy (MBCT) has increasingly been investigated in depressed patients with such ‘difficult-to-treat’ courses. This is a protocol for an individual participant data (IPD) meta-analysis aiming to determine efficacy and potential moderators of MBCT treatment effects in this group based on evidence from randomised controlled trials.

Systematic searches in PubMed, Web of Science, Scopus, PsycINFO, EMBASE and the Cochrane Controlled Trials Register for randomised controlled trials were completed on 17 June 2024. Authors of identified studies have contributed IPD, and data extractions have been completed. An update search will be conducted immediately before the start of data analyses. We will investigate the following outcomes: (a) self-reported and observer-reported severity of depression symptomatology, (b) remission and (c) clinically meaningful improvement and deterioration. One-stage and two-stage IPD-MA will be conducted with one-stage models using the observed IPD from all studies simultaneously as the primary approach. One-stage IPD models will include stratified study intercepts and error terms as well as random effects to capture between-study heterogeneity. Moderator analyses will test treatment-covariate interactions for both individual patient-level and study-level characteristics.

The results will inform understanding of the use of MBCT in patients with current ‘difficult-to-treat’ depression and will contribute to arguments in favour of or against implementing MBCT as a treatment for this group. They will be published in a peer-reviewed journal and made available to stakeholders in accessible formats. No local ethical review was necessary following consultation with the Ethics and Governance Board of the University of Surrey. Guidance on patient data storage and management will be adhered to throughout.

CRD42022332039.

To assess the magnitude and associated factors of suicidal behaviour and non-suicidal self-injury (NSSI) among youth of the Gurage Zone, Southern Nations, Nationalities, and Peoples Regional, Ethiopia, 2024.

A community-based cross-sectional study was conducted.

This research was carried out in the Gurage Zone.

This study was conducted among 719 Gurage Zone youths from 1 January 2024 to 1 February 2024.

Suicidal behaviours and non-suicidal self-injury were assessed using a pretested, interviewer-administered, structured questionnaire. Data were entered in EpiData V,3.1 and exported to SPSS V.25 for analysis. A binary logistic regression model was used to identify significant factors associated with suicidal behaviours and NSSI. Variables with a p-value less than 0.05 and adjusted ORs with 95% CI were used to declare association with the outcome variable in the final model.

Out of the total 820 study participants, 719 participants participated in the study, giving a response rate of 88%. Among 719 respondents 465 (64.7%) were males. The prevalence of high risk of suicidal behaviours was 11.7% (95% CI 8.14 to 14.30) and it is significantly associated with substance use in the last 3 months (adjusted OR (AOR)=6.84; 95% CI 3.48 to 13.47), having moderate insomnia (AOR=3.09; 95% CI 1.30 to 7.31) and having depression (AOR=6.84; 95% CI 3.48 to 13.47).

The prevalence of NSSI among youths was 38% (95% CI 34.52 to 41.86). Substance use in the last 3 months (AOR=2.459; 95% CI 1.59 to 3.81), youths having depression (AOR=3.348; 95% CI 2.29 to 4.91), youths who were exposed to stressful life events (AOR=9.86; 95% CI 6.46 to 15.07) were significantly associated with NSSI.

Nearly 1 in 10 youths in the Gurage Zone exhibited high-risk suicidal behaviour, and over one-third reported NSSI. Suicidal behaviour was significantly associated with substance use, depression and moderate insomnia, while NSSI was significantly associated with substance use, depression and exposure to stressful life events. These findings highlight the prevalence of self-harm and the key factors associated with these behaviours among youth in this region.

Hospital patients are at an increased risk of falls, which are a significant safety concern within healthcare settings.¹ Understanding how the COVID-19 pandemic has influenced fall risks is essential for identifying key factors that could inform future fall prevention strategies.² This scoping review aims to explore the barriers and challenges associated with preventing inpatient falls in the context of the post-COVID-19 environment.

The methodology for this scoping review follows the framework established by Arksey and O’Malley. A comprehensive literature search will be conducted using specific keywords to identify relevant published studies. Searches will be performed across selected electronic databases, including PubMed/MEDLINE, CINAHL, Scopus, ProQuest and Web of Science, covering publications from 2014 to 2024. This review will focus on a global perspective. Two authors will independently screen titles and abstracts to identify potential studies for inclusion. Studies meeting the inclusion criteria will be retrieved for full-text review, and their references will be assessed for relevance using the same criteria. The PRISMA flow diagram will guide the review process. Data will be extracted, analysed and charted according to categories from the selected publications.

This scoping review will provide a comprehensive overview of the barriers and challenges in preventing inpatient falls in the post-pandemic context. The findings will be disseminated through submission for publication in a scientific journal.

This scoping review protocol is registered with Open Science Framework (OSF) available at https://osf.io/.

Falls are highly prevalent among individuals with dementia, largely due to the cognitive and physical impairments associated with the condition. Understanding the barriers and challenges to fall prevention in community-dwelling individuals with dementia is essential for developing tailored strategies that address their unique risks. Despite the existing evidence on fall prevention in older adults, few reviews specifically examine the obstacles faced by persons with dementia and their caregivers in community settings. This scoping review, therefore, aims to map the barriers and challenges to preventing falls among community-dwelling individuals with dementia.

This review will follow Arksey and O’Malley’s five-stage framework and be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses—Extension for Scoping Reviews checklist. Six electronic databases (PsycINFO, PubMed, Web of Science, Cumulative Index to Nursing and Allied Health Literature, Scopus and Embase) will be searched for relevant studies published between 2014 and 2024. Grey literature sources, including dissertations and conference proceedings, will also be included. Data will be charted and synthesised thematically to provide an overview of barriers and contextual factors influencing fall prevention. The study commenced in August 2025 and is expected to be completed by February 2026.

As this review involves the analysis of existing literature, ethical approval is not required. Findings will be disseminated through peer-reviewed publications, conference presentations and summaries tailored for healthcare providers and caregiver groups.

The protocol is registered with the Open Science Framework: https://osf.io/gnw47/(dataset).

To explore the challenges and opportunities in clinical skills teaching and learning among faculty, final-year medical students and patients at a private medical university in Pakistan, within the context of a low- and middle-income country (LMIC) medical education system.

An exploratory descriptive qualitative design using inductive thematic analysis utilising in-depth interviews and focus group discussions, framed within a metaphorical lens.

A single private-sector tertiary care teaching hospital and affiliated undergraduate medical college in an urban setting in Pakistan.

A total of 48 participants were included in the study: 12 clinical faculty members representing various disciplines and levels of experience, 16 final-year medical students and 10 house officers and 10 patients from adult inpatient wards. Participants were purposively selected to ensure maximum variation in perspectives.

Six key metaphorical themes emerged, each reflecting both the challenges and opportunities within the clinical learning journey: (1) The Safety Harness—simulation as an opportunity for structured, risk-free skill development, yet limited by authenticity; (2) The Underwater Life—the irreplaceable but unpredictable nature of bedside learning in fostering empathy and communication; (3) The Stormy Seas—systemic and cultural barriers such as patient availability, gender constraints and limited faculty resources; (4) The Ship—students navigating self-development amid evolving expectations, digital distractions and shifting motivations; (5) The Engine Room Tools—balancing diverse teaching modalities while seeking optimal time distribution between simulation and bedside learning; and (6) The Guiding Compass—the pivotal role of clinical teachers as mentors and professional exemplars. Triangulated perspectives revealed that while structured simulation and bedside experiences complement one another, significant institutional, ethical and pedagogical challenges persist, many amplified by the realities of resource-limited LMIC settings.

This study underscores the complexities of clinical teaching and learning in an LMIC context, highlighting the need for a balanced, context-sensitive model that integrates simulation with authentic bedside exposure, supported by mentorship and reflective practice. Addressing structural and faculty-related barriers is essential to advancing equitable, patient-centred clinical education in resource-constrained environments.

Pneumonia and diarrhoea are two of the major causes of child mortality globally. Countries affected by conflict and other humanitarian emergencies, such as Somalia, have a particularly high burden of these diseases. Published reports from UNICEF and WHO have shown that various factors, including social, economic and environmental factors, are all associated with the occurrence of childhood pneumonia and diarrhoea. The objective of this study was to determine the prevalence, burden and associated sociodemographic determinants of pneumonia and diarrhoea among children younger than 5 years (under-5 children) in Somalia.

A community-based survey using an interviewer-administered questionnaire was conducted employing a modified WHO Expanded Program on Immunization (EPI) 30-Cluster sampling technique to identify households and respondents in nine selected districts across six member states in Somalia. The interviewers began selecting households starting from house number 1 and continued until 75 households were surveyed in each cluster.

We considered the catchment areas of 12 target maternal and child health (MCH) centres as our study areas. Villages were considered as primary sampling units (PSU) while households within villages were considered as secondary sampling units, where women (with under-5 children) within households were the respondents.

A total of 36 clusters (villages) were selected from the catchment areas of 12 target MCH centres. All households within the selected villages’ PSUs were listed. The interviewer started interviewing from house number 1 and continued till 75 households were covered to conduct interviews with mothers of under-5 children. Data collection took place between October and December 2023.

The prevalence and burden of childhood pneumonia and diarrhoea were estimated. A logistic regression model was employed to examine the determinants of childhood pneumonia and diarrhoea.

A total of 2483 under-5 morbidities were reported, 1712 probable pneumonia cases and 825 diarrhoea cases. Our calculations suggest that the prevalence of overall under-5 morbidity was 458.4 per 1000 children (95% CI 444.3 to 472.6) in the last 90 days. The prevalence of pneumonia and diarrhoea was 316.0 (95% CI 303.5 to 328.8) and 152.3 (95% CI 142.2 to 162.8) per 1000 under-5 children, respectively. A total of 70 under-5 deaths occurred in the past year, of which 37 were infants. Our exploration depicts an under-5 mortality rate of 39.3 deaths per 1000 live births per year (95% CI 30.6 to 49.7), and the infant mortality rate was 20.8 per 1000 live births per year (95% CI 14.8 to 28.6) in the study area, which is much lower than earlier estimates. The crude birth rate was 106.6 per 1000 population, and the stillbirth rate was 149.8 per 1000 births (95% CI 134.9 to 165.7), which is very high. We explored probable causes of 70 under-5 deaths and found that the highest proportion of under-5 deaths (22.9%) was due to acute respiratory infections (ARI), and about 15.7% were due to diarrhoea. Among other probable causes, congenital diseases (12.9%), accidents (11.4%) and measles (8.6%) were noteworthy.

This study revealed a high burden of pneumonia and diarrhoea among the studied population in Somalia. The study also identified important sociodemographic and environmental determinants that tend to increase the risk of pneumonia and diarrhoea among under-5 children.

Patients undergoing total hip arthroplasty (THA) and total knee arthroplasty (TKA) are considered to have a symptomatic venous thromboembolism (VTE) risk of 1.0%–1.5% despite thromboprophylaxis. Fast-track treatment protocols have substantially lowered the VTE risk in most patients. Hence, the majority of patients may be unnecessarily exposed to the burden and risk of thromboprophylaxis. On the contrary, there are still patients with a high VTE risk who develop VTE despite thromboprophylaxis. Thus, tailored thromboprophylaxis treatment may potentially reduce both VTE and bleeding risk.

The DISTINCT (inDividual, targeted thrombosIS prophylaxis versus the standard ‘one-size-fits-all’ approach in patients undergoing Total hIp or total kNee replaCemenT) trial is a national, multicentre, randomised, multiarm, open-label trial. The main objective is to study whether tailored thromboprophylaxis reduces the occurrence of symptomatic VTE (primary outcome) and major bleeding (primary safety outcome) within 90 days after THA/TKA in comparison with standard thromboprophylaxis. Patients with a low, intermediate or high predicted VTE risk (based on the Thrombosis Risk Prediction following total hip and knee arthroplasty score (TRiP(plasty) score)) will be included in the DISTINCT-1, DISTINCT-2 or DISTINCT-3 studies, respectively. In the DISTINCT-1 trial, 3478 patients will be randomly allocated to receive either in-hospital thromboprophylaxis or standard prophylaxis. In the DISTINCT-2 cohort study, 2500 patients will receive standard prophylaxis. In the DISTINCT-3 trial, 4100 patients will be randomly allocated to receive either 6 weeks of high-dose thromboprophylaxis or standard prophylaxis. Standard prophylaxis consists of a low dose of any approved thromboprophylactic agent for 4 weeks. We hypothesise that (1) the efficacy of in-hospital only thromboprophylaxis is non-inferior in preventing VTE and equally safe compared with standard prophylaxis in patients with a low VTE risk (DISTINCT-1) and (2) prolonged high-dose thromboprophylaxis is superior in preventing VTE as compared with standard prophylaxis in patients with a high VTE risk (DISTINCT-3). Patients with intermediate VTE risk will be observed to evaluate VTE and bleeding rates (DISTINCT-2).

The protocol has been approved by the Medical Research Ethics Committee Leiden-Den Haag-Delft, EU-trial-number 2023-510186-98. Study results will be disseminated through peer-reviewed journals and during international conferences.

NCT06581965.

Breast cancer is the most common cancer among women globally. While the impact of lifestyle factors like smoking and obesity on breast cancer risk and survival is well documented, the effect of working conditions is not fully understood. Moreover, breast cancer can reduce employability, making it crucial to identify factors that facilitate return to work and improve life satisfaction. Since breast cancer is affected by sleep and lifestyle, which are related to working conditions, understanding how they affect breast cancer outcomes is key. This study aims to explore the relationship between working conditions and breast cancer outcomes, including incidence, mortality and survival within a causal framework. Our specific aims are to understand the relationship between (1) working conditions and occupational groups and breast cancer outcomes, including the extent to which sleep, lifestyle and breast cancer screening uptake explain these relationships and (2) prediagnosis working conditions, sleep and lifestyle and their effect on return to work and life satisfaction among breast cancer survivors.

We will use data from the UK Biobank, a large-scale cohort study with data on 273 825 women between 40 and 69 years old at baseline, followed from 2006 to 2022. The data has been linked with death and cancer registries and includes 8309 incident breast cancer cases. To quantify the effect of working conditions on breast cancer outcomes (aim 1) and their effect on return to work and life satisfaction (aim 2), we will implement g-methods to estimate the average causal effect and employ counterfactual-based mediation analysis to quantify how much mediating factors, such as sleep and lifestyle, explain this effect.

UK Biobank received ethical approval from the North West Multi-Centre Research Ethics Committee. No further ethical approval was required for the proposed research project. In line with the two aims, four original research manuscripts will be published in open-access peer-reviewed journals to disseminate the findings. In addition, findings will be disseminated at international conferences and scientific meetings.

Mental health issues such as depression and anxiety are highly and disproportionally prevalent among university students. Beyond the academic rigour, stressors imposed by a new environment result in them being vulnerable to the onset and manifestation of mental health symptomatology. Leveraging smartphones and wearables for digital phenotyping capabilities is an innovative approach for monitoring and intervening in the mental health conditions of university students. This provides a unique opportunity to collect and identify digital and behavioural biomarkers, subsequently enabling the development of predictive models to identify university students at risk.

This study—Brightline—will employ an observational study design over a 6-month period, recruiting 500 students from a major public university in Singapore. Passive data collection will occur continuously throughout the monitoring period through a wearable device (Fitbit Charge 6) and smartphone sensors via the Brightline app, which uses a digital phenotyping data collection platform. Active data collection will consist of self-report questionnaires to be completed at the beginning of the study and follow-up assessments at 1, 3 and 6 months after. The passive and active data collected will be analysed to identify the digital biomarkers associated with depression, anxiety, stress, loneliness and affect among university students. Predictive models of these mental health issues will also be developed.

This study was approved by the Nanyang Technological University Institutional Review Board (IRB-2023-894). Findings from this study will be published in peer-reviewed journals and presented at academic conferences.

NCT06770075.

Diabetes mellitus (DM) and depression commonly coexist. Each condition increases the risk of developing the other and adversely affects treatment outcomes. Such complex interactions of diseases, referred to as syndemics, have not been well studied. This study aims to assess the syndemics of depression, sick role and activation status among newly diagnosed adults living with DM.

A prospective 6-month follow-up study will be conducted with 485 participants. Depression will be assessed with the 9-item Patient Health Questionnaire, applying a cut-off score of 10. The primary outcome will be glycaemic control, and the secondary outcomes will be health-related quality of life (HRQoL) and functional disability status. Depression, the primary outcome and the secondary outcomes, will be measured at baseline, 3 months and 6 months. The sick role, activation status and health system perspectives will be explored using qualitative methods following the second measurement. Data will be collected from adults living with DM, healthcare providers and healthcare managers. Qualitative sampling will continue until data saturation is reached.

Quantitative analysis will be done using STATA V.17. The prevalence of depression will be determined at baseline. Associated factors will be analysed using Poisson regression with a robust variance estimator. Incidence rate of depression, glycaemic control, HRQoL and disability status will be measured at 3 and 6 months. A multilevel mixed-effects generalised linear model will be fitted, with the three measurement time points nested within individuals, and individuals nested within health institutions. Qualitative data will be analysed thematically using NVivo V.12 software.

Ethics approval has been granted by the institutional review board of Bahir Dar University (protocol number 3098/25). Findings will be disseminated through peer-reviewed publications, conference presentations and local channels for community audiences.

Protocol number 3098/25.

The mental health of people living with HIV (PLWH) is a growing concern globally, particularly in sub-Saharan Africa (SSA), where there is limited access to mental healthcare, with evidence showing high levels of depression, anxiety and neurocognitive disorders among this population. While Mental Health Disorders (MHDs) can impede HIV care and promote adverse health outcomes, there is limited literature on MHDs among PLWH. This scoping review will explore the existing literature on the burden and factors associated with MHDs among adults living with HIV in SSA.

Arksey and O’Malley’s methodological framework will guide the search of this scoping review. Relevant original research articles published in English from 1 January 2000 to 31 May 2025 on MHDs among PLWH in SSA will be identified through searches in the African Index Medicus, African Journal Online, PubMed and Embase databases. Four independent reviewers, working in pairs (one reviewer and one verifier), will screen the titles, abstracts and later the full texts, adopting the population, concept and context framework. Other coauthors will serve as tiebreakers whenever there is disagreement on the eligibility. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews flowchart will be presented. We will perform a narrative synthesis to report our findings.

This scoping review protocol does not require ethical approval, as it relies solely on publicly available existing data and does not involve human participants. We will disseminate the findings from this review through peer-reviewed publications and presentations at local and international conferences.

The protocol was registered in the Open Science Framework (https://osf.io/8ymqu).

Frontotemporal lobar degeneration (FTLD) is the second most common early-onset dementia. Several studies demonstrated that neuroinflammation and iron accumulation occur in FTLD. However, the timing and relevance of these processes and whether these two are merely cause or consequence remains unclear. Elucidating the role is crucial to assess the rationale for using anti-inflammatory therapies in FTLD. Additionally, the process of glymphatic brain clearance has gained attention as a potential contributor in the disease pathophysiology.

In this multimodal biomarker study, we use a combination of ultra-high field (7T) MR, blood and cerebrospinal fluid (CSF) biomarkers to investigate the role of neuroinflammation, iron accumulation and brain clearance in FTLD, and to identify biomarkers to differentiate FTLD-TDP from FTLD-tau. We aim to include 25 patients with probable FTLD-tau, 25 with probable FTLD-TDP and 50 healthy individuals with 50% risk to develop FTLD. We will use several MRI techniques, including magnetic resonance spectroscopy, diffusion weighted spectroscopy and quantitative susceptibility mapping. In addition, we will assess the prevalence of perivascular spaces (PVS) and the mobility of CSF to address glymphatic brain clearance. We will compare quantitative MR markers between patients with FTLD-tau and FTLD-TDP, presymptomatic mutation carriers and healthy controls, and correlate these measures with clinical data and biomarkers in blood and CSF.

We obtained ethical approval from the Medical Ethics Committee Leiden Den Haag Delft (NL78272.058.21). The results will be disseminated through presentations at national and international conferences, open-access peer-reviewed publications, ClinicalTrials.gov and to the public through social media posts and annual newsletters.

NCT06870838; Pre-results.

Prescribing antibiotics may reinforce patients’ beliefs that antibiotics are needed and increase future consultations for similar symptoms. This review determines the effect of antibiotic prescribing for respiratory infections in primary care on future reattendance.

A systematic review and meta-analysis of randomised controlled trials (RCTs) and cohort studies and reported following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Participants were adults or children presenting with respiratory infection in primary care.

MEDLINE (Ovid), PubMed, Embase, the Cochrane Central Register of Controlled Trials, clinical trial registries and grey literature sources were searched from inception until 6 February 2024.

Eligible studies included open-label RCTs or cohort studies of antibiotics compared with no antibiotics in adults or children with respiratory infections. The outcome of interest was reattendance at least 28 days after the initial consultation.

Two reviewers independently screened, selected, assessed the quality and extracted data. Separate meta-analyses were presented for RCT and cohort studies and a combined meta-analysis of all studies.

We identified 2128 records and reviewed 48 full texts, of which five met the inclusion criteria. These reported three RCTs (1207 randomised to antibiotics, 672 controls) and three cohort studies (209 138 exposed to antibiotics, 46 469 controls). In the meta-analysis of RCTs, relative risk (RR) of reattendance with antibiotics was 1.10 (95% CI: 0.99 to 1.23), and in cohort studies, RR was 1.21 (95% CI: 0.94 to 1.49). An important limitation is that most studies were in UK primary care.

Evidence suggests prescribing antibiotics for acute respiratory tract infections in primary care probably modestly increases future reattendance for similar conditions. Reducing antibiotic prescribing may help decrease demand for primary care.

CRD42023470731.

It is unclear how mis- and disinformation regarding healthcare policy changes propagate throughout Latino communities via social media. This may lead to chilling effects that dissuade eligible individuals from enrolling in critical safety net programmes such as Medicaid. This study will examine pathways and mechanisms by which sentiment in response to mis- and disinformation regarding healthcare policies on social media differentially impact health disparity populations, thus supporting the design of tailored social media interventions to mitigate this.

We will search social media from X/Twitter, Facebook/Instagram and Reddit for keywords relating to health benefit programmes. Demographic, geographical location and other characteristics of users will be used to stratify social media data. Posts will be classified as fake-news-related or fact-related based on curated lists of fake-news-related websites. The number, temporal dissemination and positive or negative sentiment in reacting to posts and threads will be examined using the Python-based Valence Aware Dictionary and sEntiment Reasoner (VADER). Using a crowd-sourcing methodology, a novel Spanish-language VADER (S-VADER) will be created to rate sentiment to social media among Spanish-speaking Latinos. With the proposed approach, we will explore reactions to the dissemination of fake-news- or fact-related social media tweets and posts and their sources. Analyses of social media posts in response to healthcare-related policies will provide insights into fears faced by Latinos and Spanish speakers, as well as positive or negative perceptions relating to the policy over time among social media users.

Our study protocol was approved by the University of California, Los Angeles IRB (IRB#23–0 01 123). Results from this study will be disseminated in peer-reviewed journals and conference presentations, and S-VADER will be disseminated to public repositories such as GitHub.