To assess the level of alarm fatigue among intensive care unit (ICU), cardiac care unit (CCU) and emergency room (ER) nurses, identify associated demographic and occupational factors, determine the most frequent sources of alarms and evaluate nurses’ psychological reactions to alarms.

A cross-sectional, descriptive–analytical study.

ICUs, CCUs and ERs of six public teaching hospitals affiliated with Tehran and Kashan Universities of Medical Sciences in Iran.

Using a multistage stratified random sampling method, 285 nurses were approached, of whom 260 completed and returned the questionnaires (response rate: 91%). Participants were registered nurses with at least a bachelor’s degree or higher and 3 months of experience in ICUs, CCUs or ERs.

The primary outcome was the level of alarm fatigue measured using the validated Nurses’ Alarm Fatigue Questionnaire. Secondary outcomes included factors associated with alarm fatigue and nurses’ reported psychological responses to frequent alarms.

The mean score of alarm fatigue was 26.4±7.9, indicating a moderate level. After adjusting for confounders and hospital-level clustering using multivariable mixed-effects regression, higher monthly income was significantly associated with lower alarm fatigue (β=–0.15, p=0.03), and nurses working rotational shifts reported significantly higher fatigue compared with those with fixed shifts (β=0.18, p=0.02). Other demographic and occupational factors were not significant. Reported psychological reactions to alarms included indifference (14%), irritability (18%) and anxiety/stress (15%).

ICU, CCU and ER nurses experience a moderate level of alarm fatigue, with income and shift type as independent associated factors. The association between income and alarm fatigue may reflect the role of financial stress as an additional job demand that compounds the burden of frequent alarms, particularly in contexts where low base salaries lead nurses to rely on overtime and multiple shifts. These findings underscore the need for targeted managerial and educational interventions, including shift schedule optimisation and attention to workload-related stressors, alongside alarm prioritisation strategies. Due to the cross-sectional design, causal inferences cannot be drawn.

Chagas disease affects millions of individuals across Latin America and imposes a substantial economic burden on healthcare systems, particularly in rural and underserved regions. Chronic Chagasic cardiomyopathy remains one of the leading causes of heart failure-related mortality in endemic countries. Tissue inhibitor of metalloproteinases-1 (TIMP-1) has emerged as a potential biomarker of myocardial fibrosis in cardiomyopathies. This study was designed to investigate the association between TIMP-1 and myocardial fibrosis in chronic Chagas disease and to assess its potential as an early biomarker of fibrotic remodelling.

Bottom of form: The PTICH trial is a single-centre, prospective observational cohort study conducted at a government reference clinic in Pernambuco, Brazil. The study aims to enrol 210 adults with Chagas heart disease: 140 without ventricular dysfunction (left ventricular ejection fraction (LVEF) ≥52% in women and ≥54% in men) and 70 with ventricular dysfunction (LVEF

The Research Ethics Committee (REC) of Chagas disease and heart failure outpatient clinic—PROCAPE approved the PTICH trial (CAAE number: 65746322.8.1001.5192). Written informed consent has been obtained from all participants enrolled to date, and data handling is in compliance with applicable privacy and data protection regulations. Study findings will be disseminated through targeted outreach to civil society, the scientific community, healthcare professionals and Brazilian Unified Health System (SUS) policymakers; school-based science communication activities conducted in collaboration with state education departments (potentially including oral health educational materials); policy briefs and targeted reports for public health managers; technical meetings and institutional presentations; a plain-language summary published on the institutional website; and submissions to peer-reviewed journals and presentations at academic and health policy conferences.

RBR-3dcrj98.

Knee osteoarthritis (KOA) is a prevalent degenerative joint disorder, often accompanied by comorbidities like type 2 diabetes mellitus (T2DM). These conditions have a significant impact on patients’ sleep quality and metabolic health. Current treatments for KOA primarily focus on symptom management, while innovative approaches targeting interconnected health outcomes remain underexplored. The lumbar knee recovery device, a non-invasive device patented in Iran, offers potential benefits by enhancing lumbar-knee synchronisation, improving blood circulation and optimising cellular metabolism. This randomised controlled trial (RCT) aims to evaluate the device’s effectiveness in improving sleep quality and regulating blood glucose levels in diabetic patients with KOA.

This RCT aims to evaluate the impact of using the lumbar knee recovery device (Kamarasa) on sleep quality, blood glucose levels, HbA1c (blood glucose control level over the past 90 days) and body mass index (BMI) in patients with T2DM and grade 1–3 KOA. The study will be conducted at the Orthopedic Clinic of Imam Khomeini Hospital, Tehran, and the Health and Wellness Clinic. Eligible participants will be randomly allocated into two groups: the intervention group (receiving 10 supervised sessions using the Recovery device over 3 months) and the control group (receiving standard KOA and diabetes care). A total of 37 participants will be included in each group. The primary outcome, sleep quality, will be assessed using the Pittsburgh Sleep Quality Index at baseline and 3 months post intervention. Secondary outcomes will include random blood glucose levels, which will be measured at 10 intervals during the study; BMI, measured at the start and end of the study and HbA1c, assessed at both baseline and post intervention. The Western Ontario and McMaster Universities Arthritis Index will be used to assess pain, stiffness and physical function, also at both baseline and 3 months. Appropriate statistical tests, including two-sample t-tests, ² tests, analysis of covariance or linear regression, will be performed based on the type of variables using SPSS V.23. Additionally, standardised intervention effect sizes will be calculated for each outcome.

Ethical approval for this study was obtained from the Research Ethics Committee of the School of Nursing and Midwifery at Tehran University of Medical Sciences with reference number (IR.TUMS.FNM.REC.1403.145). Additionally, the study protocol was registered with the IRCT under the identifier IRCT20191027045257N7 on 24 November 2024.

Iranian Registry of Clinical Trials (IRCT20191027045257N7). This clinical trial was registered on 24 November 2024.

The clinical practicum is a critical component of nursing education. In Spain, it is currently facing systemic challenges that compromise its quality and sustainability. A persistent nursing shortage, combined with increasing pressure on healthcare systems and a growing number of students intended to address this gap, is adding strain to clinical learning environments, which may compromise the capacity of nurses to provide adequate supervision and meaningful learning experiences for nursing students. This not only diminishes the quality of the training experiences, but also negatively affects the well-being of both students and nurses, further worsening the situation. This protocol outlines a study aimed at conducting an in-depth analysis of the current challenges affecting the clinical practicum and proposing a new model that effectively addresses them, with significant potential for adaptation and implementation across different health education fields and geographical locations.

The study will employ a sequential mixed-methods design comprising two integrated phases. In phase I, quantitative, qualitative and scoping review methodologies will be combined to identify current challenges and opportunities. Quantitative data will be obtained by administering questionnaires to nursing students and clinical mentors (CMs) tutoring them in Catalonia, examining potential barriers and facilitators to their mentoring role. Data will be analysed through descriptive and inferential statistics. Qualitative data will emerge from semistructured interviews with CMs and nurse coordinators, as well as from a visual elicitation technique, the ‘Emojional’ Calendar, conducted with students to understand their clinical practicum experiences. These will be analysed through an inductive thematic analysis approach. The scoping review, following the Arksey and O’Malley framework, will identify best practices in clinical practicums in nursing and other health studies globally. Phase II will involve a three-round qualitative Delphi study in which all preceding results will be presented to stakeholders and decision makers in order to redesign the clinical practicum model.

Ethical approval for this study was obtained from Hospital del Mar Clinical Research Ethics Committee (Ref #2023/11123). Results will be disseminated through peer-reviewed journals and conference presentations, as well as via strategic actions (forums and meetings with healthcare managers, deans and policymakers) and general outreach (talks, social media and websites) targeted at professionals, students and the public.

Patient decision aids (PtDAs) are effective interventions to support patient involvement in health decisions and have the potential to impact favourably on health inequities by reducing gender bias in clinical practice. The aim was to explore sex and gender reporting and differences in randomised controlled trials (RCTs) evaluating PtDAs for adults making treatment or screening decisions.

Secondary analysis of the Cochrane review of PtDAs of RCTs that reported sex and/or gender. The original review searched MEDLINE, Embase, PsychINFO and EBSCO from journal inception to March 2022. Two team members independently screened citations, extracted data and assessed risk of bias. For this secondary analysis, we only included primary outcomes from the original review. We assessed appropriate use of terminology for sex (biological attribute) and gender (social construct). When terms were used interchangeably, it was considered inaccurate. Findings were synthesised descriptively, and we used meta-analysis when two or more RCTs were conducted with females/women or males/men using similar outcome measures.

Informed values-choice congruence and the quality of the decision-making process (eg, knowledge, accurate risk perceptions, feeling informed, clear values, participation in decision making, undecided) and adverse events (eg, decision regret, emotional distress) by sex and gender.

Of 209 RCTs in the original review, 206 reported sex and/or gender, with 35 (17%) using accurate terminology. Of 206 RCTs, 70 were with females/women only, 27 males/men only, 12 analysed by sex/gender and 97 RCTs did not disaggregate findings by sex or gender. Meta-analysis comparing RCTs for females/women to usual care and RCTs for males/men only compared with usual care showed similar mean differences in knowledge scores (10.84 vs 9.38 out of 100; p=0.44). Males/men had significantly higher self-reported participation in decision making compared with females/women (RR 3.16 vs 0.95; p

In PtDA RCTs, sex and gender terms are used interchangeably and 6% analysed outcomes by sex or gender. Meta-analysis of males/men only given PtDAs showed higher self-reported decision making participation in clinical practice compared to usual care versus females/women only compared with usual care. Researchers must improve reporting sex and gender in PtDA RCTs to assess how it influences health inequities.

Adverse pregnancy and perinatal outcomes (APPOs), including pre-term birth, pre-eclampsia and gestational diabetes, can result in maternal and neonatal morbidity and mortality, parental anxiety and increased healthcare costs. A better understanding of the causes of APPOs is essential to inform lifestyle and pharmaceutical interventions for their prevention and management. Given the difficulty of undertaking randomised controlled trials in pregnant women, triangulating evidence from across methods with different sources of bias may improve causal inference for APPOs. The purpose of the Mendelian randomisation in pregnancy (MR-PREG) collaboration is to support such triangulation using genetic (eg, Mendelian randomisation (MR)) and non-genetic (eg, partner negative controls) approaches to investigate the causal effects of maternal exposures on a comprehensive set of APPOs.

The MR-PREG collaboration includes individual participant data from three birth cohorts (two from the UK and one from Norway) and UK Biobank, as well as summary data from FinnGen and publicly available genome-wide association studies (GWAS). Data have been harmonised across studies and currently include information on up to 35 APPOs in up to 707 797 women.

The main aims of MR-PREG are to strengthen the evidence base for (1) prevention, by advancing understanding of maternal lifestyle factors on APPOs, (2) the role of pre-conceptional health, by improving understanding of the effect of maternal pre-existing conditions on APPOs, and (3) treatments, by evaluating the efficacy and safety of existing medications used for pre-existing conditions, and by identifying and testing novel or repurposed therapies for APPOs. To date, our published work has mainly addressed aims 1 and 3. Examples include triangulation of evidence from MR, conventional multivariable regression and paternal negative control, showing that higher maternal body mass index increases the risk of multiple APPOs, as well as the identification of maternal circulating metabolites and proteins that may influence birth weight.

Future priorities include increasing diversity within the MR-PREG collaboration by expanding representation of participants from non-European ancestries. We are also integrating molecular data, including circulating protein levels and placental transcriptomics, to better characterise the molecular mechanisms underlying APPOs. Additionally, we are using whole-exome and whole-genome sequencing to identify novel causal genes and to inform the prioritisation of candidate therapeutic targets for APPOs.

Increasing demand for haematological specialist care makes the optimisation of referrals and outpatient workflow a priority. Automated placing of standardised test orders prior to the first appointment may provide haematologists with necessary information to reach diagnoses and initiate treatment at the first patient encounter, reducing low-value follow-up appointments. We aimed to evaluate rates of patient participation in an initiative using artificial intelligence to place standardised test orders as well as reasons for non-participation, differences in the number of participants and non-participants discharged back to primary care with a diagnosis or appropriate treatment plan, and potentially avoidable referrals.

A retrospective, multicentric cohort study.

Four academic hospitals in Madrid, Spain.

18 190 patients referred for a first haematologist appointment for 11 included presenting complaints.

Referral notes from primary care were classified using natural language processing and automated placement of standardised test order sets was carried out prior to first appointment for participating patients.

We compared demographic differences between participants and non-participants, the main motives for not participating, and the number of patients discharged back to primary care at first appointment with a diagnosis and treatment plan. Most frequent International Classification of Diseases, tenth revision codes for each of the included presenting complaints were described.

During the study period, 18 190 (41%) patients were referred for a first haematologist appointment for presenting complaints included in the intervention (‘eligible patients’), of which 612 (3.3%) patients agreed to participate in the intervention. Participants were significantly younger than non-participants. Most common motives for not participating were administrative reasons (6268, 76.9%). Only 122 (1.5%) patients expressed explicit unwillingness to participate. A significant increase in the number of patients discharged upon first appointment was observed for participants (146 (23.9%) vs 3375 (19.36%); p=0.041), signifying a 22% relative reduction in avoidable follow-up. The diagnosis ‘haematological disorders ruled out’ was constantly observed as one of the ten most common diagnoses made by the haematology specialist for all but one of the included presenting complaints.

Natural language processing of referrals from primary to specialist haematology care with automated placing of standardised test orders can decrease low-value follow-up appointments. Explicit refusal to participate was low. Participants tended to be younger than non-participants, underlining the importance of designing strategies to target the older population in order to improve participation.

Outcomes for degenerative cervical myelopathy (DCM) patients are limited by delayed and missed diagnoses, driven in part by poor professional awareness. Despite DCM being the most common cause of adult spinal cord injury, it remains under-recognised and undertaught in clinical education. Lessons from other common pathology like stroke and acute myocardial infarction highlight the potential of education to improve early diagnosis. This study will develop a professional education strategy to improve early DCM diagnosis. It will define key audiences and identify an effective delivery method, laying the groundwork for a sustained, targeted intervention.

The study aims to define who needs to know about DCM, what they need to know and how they can learn it. This will be carried out in three phases: phase 1—who and what: to establish the target population and to define core competencies for the educational intervention; phase 2—how: to create and review the educational intervention; phase 3—evaluation: to test whether the framework is an improvement to existing strategies.

Ethical approval is in place from the University of Cambridge (HBREC.2024.24). Results from the study will be disseminated through scientific publication, conference presentation, blog posts and podcasts.

CRD42023461838

We aim to identify trajectories of probable maternal common mental disorders (CMD), as well as risk and protective factors associated with maternal mental health among postpartum women during the pandemic using life course theory approach.

Prospective individual level cohort study from the Iracema-COVID Study.

Mothers (n=335) at postpartum period who delivered during the COVID-19 pandemic in the fourth largest city in Brazil.

Probable CMDs were accessed using validated instruments in five cohort waves at postpartum period. Sequence analyses (SA) were employed to extract CMD trajectories, and a set of generalised binomial logistic and log-Poisson multivariable regression models with robust variance were employed to assess risk and protective factors for probable CMDs diagnosis.

Trajectories patterns of probable maternal common mental disorders.

Fit indices demonstrated a two-cluster-SA solution of probable CMD. The patterns of probable CMDs indicated that 335 mothers were clustered into occasional/transitory (n=240, 71.64%) and mostly/persistent (n=95, 28.36%) CMD trajectories. We found that mothers with low education (OR: 2.44; 95% CI 1.13 to 5.23), single (OR: 1.97; 95% CI 1.03 to 3.75) or in a stable union (OR: 2.00; 95% CI 1.02 to 3.90) and travel time spent to access the nearest primary healthcare unit (OR: 1.02; 95% CI 1.006 to 1.04) were associated with increased OR of belonging to the mostly/persistent CMD trajectory. Deprived green areas acted as a risk factor to maternal CMDs prevalence (OR: 1.37; 95% CI 1.002 to 1.87).

This study provides evidence that individual vulnerabilities and neighbourhood deprivation play an important role in understanding maternal mental health, beyond the patterns and trajectories of probable maternal CMD due to issues confronted during the COVID-19 outbreak in the northeastern region of Brazil. Policies to prevent and treat maternal mental health issues and improvement in neighbourhood deprivation need to be developed and addressed to avoid exacerbation of probable maternal CMDs.

Bipolar disorder affects around 2% of the population and is linked with reduced life expectancy and socioeconomic burden. Depressive episodes are difficult to treat and typically more prevalent, enduring and burdensome than manic episodes. The use of antidepressants alone has limited effect and is associated with significant clinical risk through polarity switch. Current National Institute for Health and Care Excellence guidelines recommend quetiapine, olanzapine (with or without fluoxetine) and lamotrigine; however, these medications have limited efficacy, tolerability and acceptability. The ASCEnD study aims to assess the clinical and cost-effectiveness of aripiprazole plus sertraline compared with quetiapine, offering potential improvements for outcomes in bipolar depression. The study is funded by the National Institute for Health and Care Research Health Technology Assessment programme (NIHR132773).

ASCEnD is a prospective, two-arm, superiority, individually 1:1 randomised, controlled, pragmatic, parallel group, type A open-label clinical trial of aripiprazole/sertraline medication combination compared with quetiapine for bipolar depression. The study is conducted in the UK National Health Service setting with the aim of recruiting and randomising 270 participants followed-up for 24 weeks. Adults with bipolar disorder self-refer or are recruited through primary and secondary care services. The primary outcome is change in depressive symptoms 12–16 weeks after randomisation. Secondary outcomes include measures of symptom change, treatment satisfaction, tolerability, medication adherence, concomitant medication use, psychosocial functioning, quality of life and cost-effectiveness and informal carer measures of quality of life and costs of caring. The exploratory outcome is change in participant reward and punishment responsiveness. Analysis will follow a prespecified statistical analysis plan. A nested qualitative study is included to examine feasibility and acceptability of the trial design.

A Clinical Trial Authorisation from Medicines and Healthcare products Regulatory Agency, and approval from the Health Research Authority (IRAS 1007468) and North East – Newcastle and North Tyneside 1 Research Ethics Committee (23/NE/0132) were obtained. Results will be disseminated through peer-reviewed publications, conference presentations and lay summaries for participants and patient and public groups.

ISRCTN63917405.

Accurate assessment of insulin resistance, sensitivity and β-cell function is essential for early detection and management of metabolic disorders. However, reference intervals (RIs) commonly used in Nepal have been adapted from Western populations, which may not accurately reflect local physiological characteristics. Thus, this study aimed to establish population-specific RIs for fasting insulin and key insulin-related indices using a direct priori method in healthy adults from Gandaki Province, Nepal.

This cross-sectional study recruited 135 healthy adults (20–69 years, body mass index 18.5–24.9 kg/m²) representing different districts of Gandaki Province, Nepal. Fasting blood samples were analysed for glucose, insulin and lipids using standardised assays. Insulin was measured using the chemiluminescence immunoassay method. Nineteen different insulin-derived indices (Homeostasis Model Assessment 1 of Insulin Resistance (HOMA1-IR), Homeostasis Model Assessment 2 of Insulin Resistance (HOMA2-IR), Homeostasis Model Assessment for Triglycerides, Fasting Insulin to Glucose Ratio, Fasting Insulin Resistance Index, Metabolic Score for Insulin Resistance (METS-IR), InsuTAG, HOMA1-%S, HOMA2-%S, Quantitative Insulin Sensitivity Check Index (QUICKI), McAuley, Bennett, Raynaud, Glucose-to-Insulin Ratio, Fasting Insulin Sensitivity Index, Single Point Insulin Sensitivity Estimator (SPISE), reciprocal insulin, HOMA1-%B and HOMA2-%B) were calculated. Non-parametric 95% double-sided RIs (2.5th–97.5th percentiles) were established following outlier removal per Clinical and Laboratory Standards Institute-International Federation of Clinical Chemistry and Laboratory Medicine EP28-A3c guidelines.

The RI for fasting insulin was 2.63–14.56 µIU/mL (median 7.69 µIU/mL). Among the 19 mathematically correlated insulin-derived indices which are calculated from core measurements (fasting serum insulin and glucose), consistent patterns emerged across functional categories. Insulin resistance indices (HOMA1-IR: 0.56–3.50; HOMA2-IR: 0.30–1.70; METS-IR: 25.14–38.94) exhibited concordant right-skewed distributions with elevated upper limits. Conversely, insulin sensitivity indices (QUICKI: 0.32–0.42; HOMA2-%S: 58.83–233.20; SPISE: 5.75–10.86) demonstrated inverse, left-skewed patterns. Beta-cell function indices (HOMA1-%B: 0.54–322.21; HOMA2-%β: 40.74–159.52) also exhibited right skewed characteristics and revealed wide interindividual variability, reflecting preserved pancreatic reserve despite varying insulin resistance. Composite indices incorporating lipid parameters showed broader ranges, capturing additional metabolic heterogeneity.

This is the first study to define the RIs of fasting insulin and a spectrum of insulin derived indices in a Nepalese population. These findings offer a valuable framework for early detection and management of metabolic disorders in South Asian populations.

Climate change has led to extreme heat events, disproportionately affecting vulnerable populations. Heat stress during pregnancy is linked to adverse health outcomes, yet the biological mechanisms remain poorly understood. This research study aims to investigate the effect of environmental heat on maternal, fetal and infant health and examine the biological pathways linking heat stress to adverse pregnancy outcomes.

This prospective cohort study will recruit 6000 pregnant women from three districts in Sindh, Pakistan. Eligible participants ≥18 years old, will have a minimum of five scheduled visits from

The study has received ethical approval from the Aga Khan University (AKU) (Ref: 26249) and the Pakistan National Bioethics Committee (Ref: 1065/23/1736). Written informed consent will be obtained from all participants before enrolment. Referral pathways to healthcare facilities will be established to ensure timely management of pregnancy complications. Findings will be disseminated through peer-reviewed publications, scientific conferences, and engagement with policymakers and public health stakeholders to inform climate-resilient maternal health strategies. Results will also be shared with participants and communities through meetings and informal sessions to raise awareness and support evidence-based heat adaptation.

NCT01234567.

Strong primary healthcare enhances resource efficiency and resilience. Type 2 diabetes poses a growing global health challenge, with Argentina’s healthcare system struggling to detect and manage the disease effectively. Many patients bypass primary healthcare for secondary facilities, undermining continuity of care and increasing costs. Following a diagnostic process in collaboration with policymakers, we propose evaluating a redesigned primary care model consisting of codesigned evidence-based implementation strategies to improve type 2 diabetes management in Mendoza, Argentina.

This is an efficient, parallel-arm cluster randomised controlled Hybrid Type II trial with 12 clusters (administrative areas with 2–3 health facilities) allocated 1:1 to control (usual care) or intervention. In phase I, we will codesign, pilot and refine an implementation strategy package. In phase II, we will conduct the trial: 9-month baseline data collection, 15-month intervention and 6-month sustainability period. We will enrol a cohort of 396 patients with type 2 diabetes at primary healthcare centres and follow them for 12 months during the intervention and 6 months sustainment using routine clinical records and patient surveys. In phase III, we will conduct analysis, report and disseminate findings. The primary outcome will be a composite outcome including glycaemic control (glycated haemoglobin (HbA1c)

All study activities will comply with national and international ethics guidelines, presenting minimal risk to participants. The protocol was submitted and approved by the local independent ethics committee at the Mendoza Ministry of Health (Consejo Provincial de Evaluación ética en investigación en Salud-Provincial Health Research Ethics Review Board, Reference number: 149/2024). Facility-level permission will be obtained for participation and sharing of deidentified data. Written informed consent will be required from study participants, who will receive information on the study’s purpose, procedures, risks and benefits. Dissemination activities and outputs will include writing and submitting manuscripts for publication; writing policy briefs to support strategy implementation in other regions or countries; and tailoring outputs for patients, clinicians and researchers. We anticipate that improvements in disease management and patient experience will have clinical and economic benefits related to reduced usage of secondary-level and tertiary-level facilities, lower cost per visit and a reduced number of clinical events related to diabetes.

ISRCTN63277390.

Alcohol use disorder and treatment-resistant depression (TRD) often co-occur, presenting a major clinical challenge with limited effective treatments. However, ketamine produces rapid antidepressant effects and has shown promise in reducing alcohol use, and acceptance and commitment therapy (ACT) can be effective for both substance use and mood disorders. This study explores the feasibility and acceptability of combining ACT with ketamine within the framework of the Montreal Model—a structured, integrative psychedelic ketamine therapy developed for severe TRD.

This study is a single-group, open-label feasibility trial at the Centre hospitalier de l'Université de Montréal (CHUM) Neuromodulation Ketamine Clinic in Montreal, Canada. 30 participants diagnosed with both alcohol use disorder and treatment-resistant depression will receive eight weekly in-person or virtual ACT sessions in addition to six intravenous ketamine infusions. The primary outcome is feasibility, assessed through study completion and protocol adherence. Secondary outcomes include recruitment rate, tolerability, safety, data completeness and healthcare resource use. Exploratory measures will examine changes in depressive symptoms, alcohol use and quality of life using validated tools. A subset of participants will participate in semistructured qualitative interviews to explore their experiences.

This study was approved by the ethics committee of the CHUM on 14 May 2025. The results of the trial, including primary and secondary outcomes, will be published in peer-reviewed scientific journals.

NCT06620276.

Severe mental illness such as psychosis is among the most disabling illnesses worldwide, disproportionately affecting minoritised ethnic groups and those in socioeconomic disadvantage. In the UK, people from Black ethnic backgrounds are more likely to experience a first episode of psychosis and to be detained under the Mental Health Act than White British people. There is a clear need for mental health services to improve cultural awareness and understanding of the broader social needs of minoritised groups, as well as the need to improve mental health literacy (MHL) within Black communities to empower individuals to seek timely mental health support. This protocol describes our programme of work which aims to assess the feasibility, acceptability and cost-effectiveness of Co-STARS, which is a co-produced, culturally appropriate tiered training package.

We co-produced a culturally appropriate, place-based, tiered MHL training package (Co-STARS) to deliver within underserved Black communities and via an e-learning package implemented among staff within mental health trusts. The training will be evaluated in stages. First, a pilot cluster randomised controlled trial will assess the feasibility and acceptability (defined as participants’ perceptions of the training’s relevance, usefulness and delivery) of a lived experience-led MHL training package delivered by Black young people with experience of mental ill health, to underserved communities in Birmingham, UK. Acceptability will be quantified through participation and completion rates and explored qualitatively via focus groups and interviews. Second, a stepped-wedge cluster randomised trial will evaluate the feasibility of an e-learning training programme for mental health professionals. We will embed a process evaluation to explore change mechanisms and identify barriers and enablers for future implementation. Third, we will use realist-informed participatory systems mapping and novel epidemiological analyses to explore downstream effects (ie, improved care access for Black ethno-racial groups within the intervention areas). Last, a cost-effectiveness framework will be developed to assess whether the intervention is good value for money in future efficacy trials. In the cluster trial, eight clusters will be randomised to the intervention arm (face-to-face training in the community) and control arm (display of MHL materials) with pre- and post-assessments in 120 participants from 8 clusters, 3 weeks apart. In the stepped wedge trial, six clusters (clinical teams within NHS mental health trusts) including 120 NHS staff in total, will move from control phase to intervention phase in a stepped wedge manner, with pre-assessments and post-assessments.

This proposal was reviewed by the Research Governance of the University of Birmingham and UK Research and Innovation (UKRI) grant reviewers. Ethics approval was granted by East of Scotland Research Ethics Service. The findings will be communicated in research conferences, stakeholder meetings, via social media, through publication in peer-reviewed journals and as a policy document.

ISRCTN10517405.

Colorectal cancer (CRC) is one of the most common cancers worldwide. Stage II/III patients undergo curative-intent surgery yet still face the recurrence risk. Detecting recurrences early provides the best opportunity for optimal treatment. We aimed to develop a microsimulation model to evaluate CRC management-associated outcomes based on current guidelines, including the performance of guideline-recommended surveillance in detecting recurrences.

Two separate individual-level state transition (microsimulation) models for colon and rectal cancer were built with a lifetime horizon using monthly cycles. The models integrated treatment and surveillance strategies per current guidelines.

The currently recommended surveillance modalities by National Comprehensive Cancer Network guidelines for surveilling patients with CRC after curative-intent surgery.

65-year-old patients with stage II and stage III CRC who underwent curative-intent surgery in the USA.

Cumulative recurrences, detected recurrences, detection rate, overall survival and recurrence-free survival in a 5-year horizon, as well as average life expectancy, were the outcome measures used.

Over 5 years, disease recurrence was observed in 9.5% of patients with stage II–III colon cancer and in 38.0% of patients with stage II–III rectal cancer. Of these, 82.5% and 85.5% were detected via surveillance, respectively, within 5 years. The predicted 5-year overall survival was 86.0% for colon cancer and 69.3% for rectal cancer, with corresponding recurrence-free survival rates of 78.9% and 53.8%. Based on current guidelines-recommended surveillance, detecting one colon cancer recurrence requires 148 carcinoembryonic antigen (CEA) tests, 37 CT scans and 21 colonoscopies. In contrast, detecting one rectal cancer recurrence requires 31 CEA tests, 8 CT scans and 4 colonoscopies.

Our validated model suggests that relative to an optimal benchmark in which all recurrences are detected, recurrence detection under current guidelines may be suboptimal, indicating room for improvement. As new tests emerge, this model could be a valuable tool for evaluating existing clinical practices and the potential of new tests to enhance patient outcomes.

The COVID-19 pandemic threatened global HIV Test and Treat Efforts. We assessed whether it affected (1) the number of antiretroviral therapy (ART) initiations and (2) the proportion of timely ART initiations in people living with HIV (PLWH) globally.

Quasi-experimental, regression discontinuity design using routinely collected data from HIV clinics.

360 HIV care clinics across primary and secondary levels of care, participating in the International epidemiology Databases to Evaluate AIDS consortium, in 31 countries in Asia, Africa and the Americas.

177 391 PLWH (≥18 years old) who initiated ART 2 years before and 1 year after the onset of the COVID-19 pandemic in their country.

The primary outcome was the number of ART initiations per week; the secondary outcome was the proportion of timely ART initiations (ie, ART initiated within 7 days of enrolment). We assessed changes in these outcomes in the 52 weeks after compared to the 104 weeks before the pandemic onset, defined using each country’s peak Oxford Stringency Index score between January and June 2020.

Among 177 391 newly enrolled PLWH, 129 743 initiated during the pre-pandemic and 47 648 post-pandemic onset. 72.5% of ART initiations were timely pre-pandemic whereas 82.3% were during the pandemic. Absolute number of ART initiations remained stable during the pandemic period in 25 of 31 countries but decreased significantly in six countries: India (–5.0 p, 95% CI –9.2 to –0.7), Rwanda (–10.0 p, –18.6 to –1.4), Malawi (–33.4 p, –54.1 to –12.3), South Africa (–130.8 p, –188.6 to –73.1), Zimbabwe (–12.9 p, –20.0 to –5.8) and Togo (–19.6 p, –39.1 to –0.1). The proportion of timely initiations was stable in all countries except in Kenya (+4.2 pp, 95% CI +0.3 to +8.1) and in Mozambique (+2.7 pp, +0.5 to +4.9), where it increased significantly.

A deeper understanding of the factors that contributed to sustaining ART initiations, particularly in settings with stringent public health and social measures, is needed. These insights should inform preparedness strategies, resource allocation and policy development to ensure continuity of HIV services during future health emergencies, in line with World Health Organisation recommendations.

Previous studies suggest Ireland has the smallest osteoporosis treatment in Europe and very little inappropriate prescribing, in contrast to our experience. In this study, we examine the osteoporosis treatment gap in Ireland by assessing the prevalence of appropriate and inappropriate prescribing in 2 subgroups of the Irish dual-energy X-ray absorptiometry (DXA) Health Informatics Prediction (HIP) Project. Treatment eligibility was defined using established intervention thresholds, including prior fracture, femoral-neck T-score ≤–2.5, glucocorticoid use, or Fracture Risk Assessment Tool (FRAX) major osteoporotic fracture risk ≥20% or hip fracture risk ≥3%.

Secondary cross-sectional analysis of a subgroup of the DXA HIP Project Cohort.

3 hospitals in the West of Ireland. DXA referrals come from primary care providers, hospital consultants and the osteoporosis service.

5564 participants of a previously described convenience cohort including: (i) 3474 subjects referred for a DXA scan, and (ii) 2090 patients who completed a DXA scan.

82.4% were female with a mean age of 66.6 years, 59.6% of whom had a prior fracture. Prescribing data of calcium and vitamin D were available for 3738 (67.2%) subjects, and osteoporosis medication for 4157 (74.7%) subjects. Prescribing information was available for more than 99% of the DXA group, but just over 50% of the referral group. When examined in aggregate, the treatment gap is 6% for calcium and vitamin D and 38% for osteoporosis medication, in line with prior publications. However, among those with prescribing information and at least one indication for treatment, only 58.3% were prescribed calcium and vitamin D and 39.1% an osteoporosis medication. Furthermore, among patients without a clear indication for treatment, 50.6% were prescribed calcium and vitamin D, and 32.5% an osteoporosis medication.

These data suggest the majority of patients with osteoporosis or at high risk of fracture in Ireland today do not receive appropriate osteoporosis treatment, while inappropriate prescribing is substantial. These findings suggest that the true treatment gap in Ireland is substantially larger than aggregate estimates imply.

To establish consensus definitions for non-visually impairing eye conditions (NVICs) and their methods of assessments to provide standards for use in population-based eye surveys.

A literature review of NVICs in sub-Saharan Africa, a questionnaire of inquiry based on the literature review developed by an expert panel and a modified Delphi exercise with three iterative rounds with eye health experts.

Eye health academia and community eye health in Nigeria.

Nigerian ophthalmologists, including subspecialists experienced in population-based eye health surveys.

Definitions and statements where at least 70% of the respondents agreed or strongly agreed.

Forty-two ophthalmologists practising in Nigeria with experience in conducting population-based eye health surveys were invited to take part in the Delphi exercise. There were three rounds with response rates of 39/42 (92.9%) in round 1, (94.9%) in round 2 and 100% in round 3. Consensus for NVICs to be included in population-based eye surveys, their definitions and methods for assessment was reached by the third round.

We propose case definitions for NVICs to be assessed in population-based eye surveys through a modified Delphi approach with an expert panel of ophthalmologists from across Nigeria. These case definitions will allow for standardisation of NVICs in population-based eye surveys to assess the prevalence and magnitude of the different types of NVICs for planning purposes. Further studies are needed to validate these case definitions and inform their evolution.

Geriatric patients often face issues related to polypharmacy and adverse drug events. Re-evaluating prescribed medications and considering deprescribing is critical. Medication discrepancies (MDs) during care transitions can compromise patient safety, as over 60% of medication errors occur at these points. This study aimed to assess the magnitude of MDs and their contributing factors through the medication reconciliation (MedRec) process among geriatric patients in emergency departments of comprehensive specialised hospitals in northwest Ethiopia, as well as to determine the acceptance of pharmaceutical interventions.

In this multicentre prospective observational study, the best possible medication history (BPMH) was obtained within 24 hours of emergency department admission from at least two sources. A comparison of the BPMH list with medication orders from treating physicians revealed discrepancies. Data were analysed using STATA V.17.0, using multivariable logistic regression to assess variable associations.

Adult emergency departments of comprehensive specialised hospitals in northwest Ethiopia.

Overall, 384 geriatric patients with chronic conditions and current medication use who visited the adult emergency department of the hospital from 10 January 2025 to 30 March 2025 were involved in this study.

Magnitude and types of MDs, acceptance of pharmacist interventions, and factors associated with MDs.

In total, 384 patients with chronic diseases visiting the hospital emergency department were recruited in the present study. Out of 384 patients involved in the study, 218 (56.77%) had encountered at least one MD. Omission error 190 (45.24%) was the most common type of MD, followed by wrong dose 82 (19.50%). Among 420 interventions, 80.48% of the total cases were accepted. Number of previous/home medications (≥5 medicines; adjusted OR (AOR)=3.12; 95% CI 1.190 to 8.151), older age (≥75 years; AOR=1.62; 95% CI 1.054 to 2.495), and number of comorbidities (≥3; AOR=1.65; 95% CI 1.066 to 2.546) were associated factors with MDs.

This study revealed a high prevalence of MDs in the emergency department. Polypharmacy, comorbidities and older age were factors associated with MDs. The study findings show the need for a clinical pharmacist-led MedRec implementation to enhance patient safety.