Urgent and emergency care in Germany is delivered across multiple, loosely connected sectors. In the absence of coherent, time-resolved data on patient movements between emergency medical services (EMS), out-of-hours ambulatory care, emergency departments (EDs) and inpatient care, inefficiencies and coordination gaps remain difficult to quantify. A process-centric, trans-sectoral analysis is required to characterise real-world patient pathways and identify actionable levers for improvement. The study aims to reconstruct, model and analyse patient pathways for urgent health complaints across all relevant sectors of the healthcare system in a German model region.

We will employ a mixed-methods observational study design. Routine data from EMS, out-of-hours ambulatory care, EDs and subsequent inpatient care will be pseudonymised at source, linked via a trusted third party and analysed within a trusted research environment. Time-stamped event logs will support process mining for discovery, conformance and performance analysis alongside descriptive statistics with stratification by context, such as setting, time of day, urgency and patient cohorts. Anonymous cross-sectional surveys of patients and front-line professionals, complemented by quarterly snapshot surveys in out-of-hours ambulatory care and interviews, will provide convergent evidence on the motives, barriers and coordination of utilisation behaviour. Enrolment for surveys is anticipated from the fourth quarter of 2025; routine data capture covers 1 January–31 December 2026; analyses and dissemination run until 31 December 2027.

The study received ethical approval from the Ethics Committee of the Medical Faculty at RWTH Aachen University (EK 25-351). Survey modules are conducted anonymously with voluntary participation and without collection of direct identifiers; routine care data are processed in pseudonymised form and analysed within a trusted research environment. Stakeholder interviews will be conducted with informed consent. Results will be disseminated through peer-reviewed publications, conference presentations and summary reports for participating institutions and stakeholders, complemented by plain-language materials to support patient-centred navigation.

DRKS00035916.

To assess the sex-specific status of dietary diversity (DD) and its associated factors among older men and women (aged ≥60 years) in Bangladesh.

A nationally representative cross-sectional survey was conducted in 2018–2019 on food security, nutrition and health of older adults of both sexes.

Data were collected from 82 clusters (rural 57, non-slum urban 15 and slum 10) from all eight administrative divisions of Bangladesh.

A total of 4817 participants aged ≥60 years (2482 men and 2335 women) were enrolled.

A list-based (24-item) recall method was employed, and the items were later aggregated into 10 food groups. The outcome variable was the prevalence of inadequate DD, defined as consumption of less than 5 food groups out of 10.

Men and women had mean DD scores of 4.33±1.6 and 4.13±1.7, respectively. Women had a higher prevalence of inadequate DD than men (61.2% vs 56.3%, p=0.028). Among the food groups, women consumed significantly less fish and eggs than men (fish: 50.96% vs 57.76%, p=0.002; eggs: 17.13% vs 22.10%, p=0.004). Poor education, rural dwellings, living in homes with fewer individuals and living in food-insecure households were associated with inadequate DD in both sexes. Furthermore, among men, older age and not being currently married, and among women, lower age and living in households with middle wealth status were associated with inadequate DD.

The study found that older women consume relatively less diverse diets than men, and several sociodemographic factors influence inadequate DD among older adults of both sexes in Bangladesh. These factors should be considered while developing policies and programmes to promote equitable access to a diversified diet and improve geriatric health and nutritional outcomes.

Administering supplemental oxygen to prevent hypoxaemia is a fundamental treatment for patients hospitalised with acute injury or illness. However, the amount of oxygen administered frequently exceeds that needed to maintain normoxaemia, causing patients to experience hyperoxaemia and wasting supplemental oxygen. Closed-loop, autonomous oxygen titration systems are designed to optimise oxygen delivery by administering the lowest possible oxygen flow that maintains peripheral oxygen saturation (SpO₂) within a predefined range. For adults hospitalised with an acute injury or illness, it remains uncertain whether the use of a closed-loop, autonomous oxygen titration system safely increases the proportion of time spent in normoxaemia (SpO₂ 90%–96%) compared with usual care.

The Strategy to Avoid Excessive Oxygen using Autonomous Oxygen Titration Intervention trial is a multicentre, unblinded, parallel-group, randomised trial being conducted at four level 1 trauma centres in the USA. The trial compares an autonomous oxygen titration system versus usual care among 300 adults hospitalised for major trauma, burn, acute care surgery or acute respiratory illness. The primary outcome is the proportion of patient-time spent within the targeted normoxaemia range (SpO₂ 90%–96%) as measured by continuous non-invasive pulse oximetry, during the first 72 hours after randomisation. Secondary outcomes include the amount of supplemental oxygen administered and the proportion of time spent in hypoxaemia (SpO₂2 >96%). Specifying the protocol and statistical analysis plan before the conclusion of enrolment increases the rigour, reproducibility and interpretability of the trial. Enrolment began on 6 May 2024.

The trial protocol was approved by the single institutional review board at the University of Colorado School of Medicine and the Office of Human Research Oversight at the Department of Defense. We will present the results at scientific conferences and submit them for publication in a peer-reviewed journal.

NCT06374225.

Enteric fever, primarily caused by Salmonella enterica Typhi and Salmonella enterica Paratyphi A (SPA), is endemic mainly in South Asia, disproportionately affecting school-age children. Although typhoid conjugate vaccines (TCVs) are effective and implemented in many countries, no licensed vaccine exists against paratyphoid A. Bivalent vaccines targeting both S. Typhi and SPA may address this gap. Although field efficacy trials are not considered feasible, controlled human infection models (CHIMs) offer an alternative pathway for evaluating vaccine efficacy. This will be the first efficacy study of a bivalent vaccine against typhoid and paratyphoid A using a paratyphoid CHIM.

This is a phase II multicentre, double-blind, randomised controlled trial assessing the efficacy and immunogenicity of a bivalent conjugate vaccine candidate, Serum Institute of India Typhoid Conjugate Vaccine (Bivalent) (SII-TCV(B)), against SPA using a CHIM in healthy UK adults aged 18–55 years. A total of 192 participants will be randomised 1:1 to receive either SII-TCV(B) or a licensed Vi-polysaccharide typhoid vaccine (Vi-PS). All participants will be orally challenged with S. Paratyphi A (strain NVGH308) 28 days postvaccination. Participants will be monitored closely for 14 days and treated at 14 days postchallenge or promptly on diagnosis, according to prespecified criteria. The primary objective is to evaluate vaccine efficacy of SII-TCV(B) against paratyphoid infection using a CHIM. The coprimary immunogenicity objective is to assess non-inferiority of the typhoid IgG response compared with a licensed Vi-PS control.

The study has received ethical approval from the Berkshire Research Ethics Committee (24/SC/0309) and regulatory approval from the UK Medicines and Healthcare products Regulatory Agency. Results will be disseminated via peer-reviewed publications and scientific meetings.

ISRCTN65855590.

Each year, millions of people experience recurrent diverticulitis episodes. Elective sigmoid colon resection reduces the risk of recurrence, but The American Society of Colon and Rectal Surgeons recommends individualising surgical decisions based on the impact of the condition on a patient’s quality of life (QoL). However, no threshold for QoL impairment has been established to guide decision-making, and evidence comparing elective colectomy with medical management in terms of QoL limitation is limited. To address these gaps and to guide treatment decision-making, we designed the Comparison of Surgery and Medicine on the Impact of Diverticulitis (COSMID) trial.

The COSMID trial is a large, pragmatic randomised trial including patients with QoL-limiting diverticulitis that aims to determine if partial colectomy is superior to medical management and explore subgroups that are more likely to respond to each treatment.

COSMID will recruit 250 English-speaking and Spanish-speaking adults with imaging-confirmed and QoL-limiting diverticulitis (defined using a modified diverticulitis-related QoL survey). Participants are randomly assigned to undergo elective partial colectomy or receive comprehensive medical management (eg, selected from options including fibre, probiotics, mesalamine and rifaximin). A total of 100 patients who decline randomisation but consent to follow-up will be included in a parallel observational cohort. The primary outcome is the time-averaged score of the Gastrointestinal Quality of Life Index at 6, 9 and 12 months after randomisation. Secondary outcomes include clinical adverse events, healthcare utilisation, recurrent episodes of diverticulitis and additional patient-reported outcomes like the Diverticulitis Quality of Life instrument, decisional regret and work productivity. Exploratory analyses aim to identify differential treatment effects based on patients’ characteristics.

This trial was approved by the Vanderbilt Institutional Review Board (IRB) on 26 August 2019 (IRB #191217). Vanderbilt serves as the institutional review board of record for the following study sites: Albany Medical College, Allegheny Health, Atrium Health Carolinas Medical Center, Virginia Mason Medical Center, Boston University Medical Center, Cedars-Sinai Medical Center, UT Health Lyndon B. Johnson Hospital, Medical University of South Carolina, New York-Presbyterian Queens, Stanford University, University of Pennsylvania, University of California San Diego, University of California San Francisco, University of Colorado Denver, University of Florida, University of Iowa, University of Utah, University of Washington Medical Center, University of South Florida, University of Rochester Medical Center, University of Texas Southwestern Medical Center, Virginia Commonwealth University, Lahey Hospital & Medical Center, Weill Cornell Medical Center and Northwell Health. Rush University Medical Center (approved 8 January 2020), Columbia University Medical Center (approved 28 January 2020), Northwestern University (approved 19 March 2020), Mount Carmel Health System (approved 5 May 2020) and Memorial Health University Medical Center (approved 4 April 2022) are regulated and were approved by their respective IRBs. Results from this trial will be presented at international conferences and published in peer-reviewed journals.

NCT04095663.

Rubella and parvovirus B19 (B19V) infections can present with arthritis-like symptoms in adults instead of typical dermatological symptoms. We quantify associations between rubella and B19V, respectively, with arthritis-like complications using real-world diagnostic testing.

Cross-sectional and retrospective cohort study.

Reference laboratories across the USA.

Participants with IgM tests for rubella (N=211 917) or B19V (N=644 473) performed at Labcorp from 2014 to 2023. Among these participants, participants with IgM tests for rubella (N=1867) or B19V (N=22 683) and longitudinal laboratory testing through Labcorp were followed for diagnostic tests for rheumatoid arthritis (RA) up to 1.5 years after the viral IgM tests.

Primary outcomes were arthritis-like suspicions by providers and diagnostic testing for RA-associated biomarkers.

Higher proportions of suspicions of arthritis (1.4%, p

Increased awareness of non-typical RA symptoms may facilitate differential diagnosis between rubella, B19V and RA. Recent B19V infections do not occur concurrently with RA; recent B19V infections should be considered in the differential diagnosis for RA when patients present with polyarticular joint symptoms.

The COmmunity HEalth System InnovatiON (COHESION) project (2016–2019) was a 4-year collaboration between research teams from Mozambique, Nepal, Peru and Switzerland. It conducted formative health system research using tracer chronic conditions, non-communicable diseases (diabetes and hypertension) and one neglected tropical disease per country (schistosomiasis in Mozambique, leprosy in Nepal and neurocysticercosis in Peru).

Findings guided the co-creation of interventions to improve diagnosis and management through a participatory approach with communities, primary healthcare workers and regional health authorities.

As a continuation of this effort, the research team initiated the COHESION Implementation project (COHESION-I) with two objectives: (1) implement and evaluate the context-specific co-created interventions in Mozambique, Nepal and Peru (Component 1) and (2) adapt the COHESION approach to India, a country that did not benefit from a formative phase previously (Component 2). This protocol manuscript focuses on Component 1.

A mixed-methods, pre–post quasi-experimental design will be used, including quantitative, qualitative, economic and process evaluations. Each country will have three arms: (1) co-created and co-designed interventions; (2) only co-designed intervention and (3) the usual care arm. Data will be collected longitudinally over 18 months to assess the effect of the interventions. The main outcomes include patient satisfaction (Patient Satisfaction Questionnaire Short Form), health system responsiveness (WHO responsiveness domains) and quality of life (EuroQol 5 dimensions 5 levels). The qualitative evaluation will explore how satisfaction is perceived among service users with chronic conditions and healthcare workers. Other outcomes per type of evaluation will be considered such as perceived value of health services, cost estimation and acceptability of the intervention components, among others.

Approvals were obtained from Ethics Committees of Universidad Peruana Cayetano Heredia (Peru), Universidade Eduardo Mondale (Mozambique) and Nepal Health Research Council (Nepal). Results will be disseminated through peer-reviewed publications and scientific conferences.

NCT06989502.

Metabolic dysfunction-associated steatotic liver disease (MASLD) and gestational diabetes mellitus (GDM) are prevalent metabolic disorders in pregnancy, posing significant risks to maternal and fetal health. This study evaluates the effectiveness of metformin, in combination with lifestyle modifications, compared with lifestyle modifications alone, in reducing the incidence of diabetes, pro-inflammatory liver markers, adverse maternal and neonatal outcomes and total gestational weight gain in pregnant women diagnosed with MASLD in the first trimester.

This parallel-arm, randomised controlled trial will recruit pregnant women (≤14 weeks of gestation) with confirmed MASLD from antenatal clinics of tertiary care public hospitals in Puducherry, India. Participants will be consecutively enrolled until a sample size of 296 is reached. Block randomisation will ensure balanced group allocation, with allocation concealment maintained using sequentially numbered opaque sealed envelopes. The intervention group will receive oral metformin (500 mg two times per day) alongside structured lifestyle modification counselling, while the control group will receive lifestyle modification counselling alone. Primary outcomes include GDM incidence, changes in pro-inflammatory markers, MASLD grading (assessed via liver function tests and ultrasound) and adverse maternal outcomes such as hypertensive disorders, polyhydramnios, genitourinary infections, caesarean delivery and postpartum haemorrhage. Neonatal outcomes assessed include macrosomia, stillbirth, intrauterine death, birth injury, shoulder dystocia, respiratory distress and neonatal hypoglycaemia. The secondary outcome is total gestational weight gain. Participants will be followed at 24–28 weeks, 34–36 weeks and post partum (within 6 weeks of delivery). Data collection will be conducted using a pretested structured questionnaire, with data entry and management performed using REDCap software. Statistical analysis will be conducted using STATA V.4, applying both intention-to-treat and per-protocol analyses. Effect sizes will be reported as proportions and relative risks with 95% CIs, ensuring robust statistical inference.

This study provides a rigorous framework to assess metformin’s role in managing MASLD and preventing GDM, thereby promoting favourable maternal and neonatal outcomes. Findings will contribute to improved clinical management, public health strategies and policy recommendations.

The study was approved by the JIPMER Institutional Ethics Committee (JIP/AEC/2023/01/011), and the findings will be disseminated through peer-reviewed journals and academic conferences.

CTRI/2023/12/060930.

Malnutrition among under-5 children is a major challenge in low-income and middle-income countries, contributing to poor growth and development. Growth monitoring and promotion (GMP) is recommended by WHO for early detection, yet its implementation remains weak due to limited resources and health system gaps. While many studies focus on utilisation, little is known about facility readiness, especially from multicountry analyses. This study aimed to assess the readiness of health facilities to provide growth monitoring (GM) service and associated factors using nationally representative data.

Secondary analysis of existing cross-sectional survey data.

Secondary data from service provision assessment surveys of Afghanistan, Bangladesh, Ethiopia, Haiti, Nepal and Tanzania was used.

We included 6595 health facilities, which have complete information. Health facilities’ readiness score was constructed as a counting score with regard to the availability of essential indicators required to provide GM services by using WHO service availability and readiness assessment.

Among 6595 health facilities, 28.5% (95% CI 27.4% to 29.6%) of the facilities reported at least 75% of the relevant items for GM service provision. The factors associated with health facilities’ readiness to provide GM service were quality assurance activities (incident rate ratio (IRR): 1.15; 95% CI 1.07 to 1.24), separate user fees (IRR: 1.10; 95% CI 1.00 to 1.20), fixed user fees (IRR: 1.20; 95% CI 1.10 to 1.31) and presence of trained health provider at facility 24 hours (IRR: 1.09; 95% CI 1.02 to 1.17).

Health facilities in six countries showed low readiness for GMP services. Strengthening facility capacity, staffing, equipment and quality assurance is essential to improve readiness.

Despite global commitments to eliminate malnutrition, over half the world’s population remains affected. Multisectoral nutrition interventions targeting both proximate and distal causes of malnutrition are essential across the lifespan. Yet, current data collection lacks comprehensive nutrition intervention coverage measures, risking inaccuracies in tracking progress. The One Nutrition Coverage Survey (ONCS) aims to test new and refined coverage measurement methods, assess coverage equity and guide integration into large-scale household surveys.

The ONCS will be a cross-sectional, population-representative household survey conducted in four districts of Bangladesh (Rangpur, Sylhet, Dhaka and Khulna), selected for their geographic spread and urban–rural balance. A stratified multistage sampling approach will be used to select enumeration areas, and a total of approximately 3280 households randomly selected within each EA will be included in the survey. The survey will interview women of reproductive age (15–49 years), caregivers of children (0–9 years), adolescents (10–19 years) and pregnant women, collecting data on multisectoral nutrition interventions relevant to these groups. It will use both existing and new measures, while also capturing monetary and non-monetary costs for survey design to implementation. Data will be analysed to assess coverage, co-coverage and equity by sociodemographic characteristics, as well as the feasibility, accuracy and costs of the survey approach.

The study protocol and instruments were reviewed and approved by the International Centre for Diarrhoeal Disease Research, Bangladesh’s (icddr,b) Ethical Review Board in Bangladesh and the International Food Policy Research Institute’s Institutional Review Board in Washington, DC, USA. Adults provided signed informed consent and adolescents their assent. Findings will be shared through peer-reviewed publications, conferences and presentations in Bangladesh with key stakeholders. This study will yield new tools, methods and evidence for measuring multisectoral nutrition intervention coverage, applicable to other low-income and middle-income countries. Learnings from ONCS will enhance data collection aligned with national strategies, helping governments improve coverage assessments, inform decisions and strengthen programme monitoring.

Compared with other high-income countries, the USA continues to have the highest rates of pregnancy-related and associated mortality and morbidity (PRAMM), particularly in rural areas and among non-Hispanic black pregnancies. Over 80% of pregnancy-related deaths are preventable; however, the intensity of existing interventions has proven difficult to broadly disseminate. Technology offers the potential to address such barriers. This study will develop a multilevel digital intervention to reduce PRAMM and evaluate its effects using a site-randomised trial.

The Michigan Healthy Mom (MI MOM) intervention will be developed using a community-partnered approach and will seek to address PRAMM risks at four distinct levels: individual, support system, provider and community. Pregnant participants and up to three members of their personal support system will receive an initial brief interactive session through a mobile web app and will thereafter receive a series of text messages with links to extended content. Healthcare providers will receive biweekly text messages and/or flyers distributed in clinic staff areas, and community health workers—who can facilitate access to local services—will be available via secure live chat text access. MI MOM effects will be evaluated using a cluster-randomised trial in 10 antenatal care clinics throughout Michigan (N=500 pregnant participants aged 18+ years receiving Medicaid). We will compare intervention and control arms on two coprimary outcomes: total PRAMM through 1 year post partum as measured using a universally collected linked dataset of Medicaid claims and vital records and an index of PRAMM risk factors directly targeted by MI MOM.

The Michigan State University Institutional Review Board has provided ethical approval (STUDY00011005). Results will be disseminated via presentations at academic conferences and community forums, as well as publications in peer-reviewed journals.

NCT07213284.

The predictive value of carotid-femoral pulse wave velocity (cfPWV) for cardiovascular (CV) events in individuals with blood pressure (BP) 120–159/80–99 mm Hg, where more accurate risk stratification has the greatest clinical effect, is unknown. This study aims to determine whether cfPWV improves the prediction of CV events beyond traditional risk factors in individuals with moderate BP.

A systematic review and meta-analysis.

PubMed and EMBASE were searched through April 2023.

We included prospective, population-based cohort studies with ≥1 year follow-up that directly measured cfPWV as an index of arterial stiffness and reported incident CV disease (CVD), atherosclerotic CVD (ASCVD), coronary heart disease, stroke or all-cause mortality outcomes.

Individual participant data from 11 cohorts (n=15 987) were harmonised and analysed using two-stage random-effects meta-analysis. Incremental predictive and clinical utility analyses compared 10-year risk models with and without cfPWV.

There were 1279 first atherosclerotic CV events over a median follow-up of 9.9 years. A 1-SD increase in log_e(cfPWV) was associated with a 1.21-fold (95% CI 1.08 to 1.36) increase in risk of ASCVD. Adding cfPWV to traditional risk factors improved ASCVD prediction: change in discrimination (C-index): 0.0048 (95% CI 0.0002 to 0.0094), p=0.041. In hypothetical populations of 100 000 individuals with moderate BP, cfPWV-guided treatment could reduce event rates by 2.7% and 3.1% under European and US guidelines, respectively.

Adding cfPWV to traditional CV risk factors may improve the prediction and classification of first CV events in individuals with moderate BP. Additional screening with cfPWV could enhance risk stratification for antihypertensive treatment initiations.

Studying issues related to stroke medication non-adherence is essential for secondary prevention of stroke. This study aimed to identify the prevalence of medication non-adherence and risk factors among stroke survivors. The reasons behind this are that some patients may not follow stroke medication plans, and potential ways to help patients adhere better to medication plans.

This study employed a cross-sectional patient survey.

The study was conducted in 20 public and private healthcare facilities in a resource-constrained setting, in Punjab, the largest province of Pakistan.

We included 6538 stroke survivors aged 21–75 years with at least a 6 month history of stroke who were prescribed one or more anti-stroke medications and met the inclusion criteria.

The main outcome was medication non-adherence, measured by the Self-Efficacy for Appropriate Medication Scale (SEAMS) and self-reported pill count. Descriptive statistics were used to summarise study variables. chi-square (²)/Fisher’s exact test and independent t-test/ANOVA were employed. A generalised linear model (logit model using multivariable logistic regression shows that several factors are associated with medication non-adherence and adherence. Odds ratio (OR) plots were generated using Seaborn and Matplotlib.

Non-adherence based on pill counts was 49.7%, while the mean SEAMS score (31.3±7.7) showed moderate self-reported adherence. After adjusting for age, gender, marital status, education, income, health insurance, smoking status, comorbidities, stroke type, disease duration, blood pressure control, number of medications, dosing frequency, physiotherapy continuation, perceived side effects and doctor-patient satisfaction, we found that female gender (vs male: AOR 0.31, 95% CI 0.27 to 0.35), lower income (10k–25k PKR vs >100k PKR: AOR 0.31, 95% CI 0.23 to 0.41; 26k–50k PKR vs >100k PKR: AOR 0.57, 95% CI 0.47 to 0.68), primary/secondary education (vs postgraduate: AOR 0.74, 95% CI 0.64 to 0.87), controlled BP (vs uncontrolled: AOR 0.66, 95% CI 0.59 to 0.73), longer disease duration (≥5 years vs

This study addresses the significant issue of medication non-adherence in stroke patients in Pakistan, reflecting global patterns yet remaining under-explored locally. It emphasises the critical role of adherence in managing chronic conditions such as stroke, where consistent use of preventive therapies is vital for reducing recurrence and improving outcomes. While the non-adherence rates are consistent with global trends, there is a notable lack of observational studies and epidemiological data in the Pakistani context. Our findings support a comprehensive approach to enhance medication adherence, taking into account the complex connections among social, behavioural and clinical factors. It also highlights the importance of maintaining detailed records to monitor adherence trends, identify high-risk groups and inform targeted public health interventions.

To pilot a culturally tailored, peer-led, co-produced asset-based intervention workshop to encourage early diagnosis of prostate cancer for Black men.

Mixed-methods pilot study.

Community centres in the North-East of England and Scotland.

The intervention was delivered in November 2023 with Black African and Caribbean men (n=21), and again in February 2024 (n=41). Participants were highly educated and aged between 42 and 63 years. The intervention was qualitatively evaluated with 40 of the intervention participants.

Underpinned by the Integrated Screening Action Model (I-SAM), we co-produced a culturally tailored, peer-led 2-hour workshop consisting of multiple components, including small group discussions about barriers to accessing prostate cancer care, general practitioner (GP) health education, activities to facilitate effective communication with the GP and reception staff and videos with testimonials from survivors, women and religious leaders.

Knowledge, attitudes and intention to engage in prostate cancer testing were examined through a pre- and post-survey design. Intervention acceptability was qualitatively explored through focus groups.

Participants (n=41) reported that the workshop increased their confidence in engaging with healthcare providers to discuss prostate cancer testing (I-SAM component: psychological capability). Knowledge (I-SAM component: psychological capability: Z=4.939, p

Asset-based strategies, focusing on community strengths, including faith-based health promotion, can promote health behaviours in a culturally and spiritually meaningful way. The PROCAN-B intervention effectively targeted components within the I-SAM and shows potential to increase prostate cancer awareness and build confidence to engage in behaviours conducive to early diagnosis. However, the sample was small, and more robust effectiveness testing is needed.

Dementia is a chronic and progressive neurological condition characterised by cognitive and functional impairment. It is often associated with multimorbidity and imposes a significant economic burden on healthcare systems and families, especially in low-income and middle-income countries. In Peru, where dementia cases are increasing rapidly, timely detection and referral for diagnosis is crucial. This protocol is part of the IMPACT Salud project in Peru. Here, we focus on a specific component aimed at validating an mHealth tool for the detection of cognitive and functional impairment and assessing its cost-effectiveness. We will also assess changes in cognitive and functional impairment as well as health economic outcomes over 1 year.

This observational study will be conducted in four geographically diverse regions of Peru. Community health workers are expected to contact approximately 32 000 participants (≥60 years) to apply an mHealth-enabled tool that includes cognitive and functional instruments: Ascertain Dementia 8, Peruvian version of Rowland Universal Dementia Assessment Scale and Pfeffer Functional Activities Questionnaire. From this large sample, we aim to find 3600 participants and their study partners to enrol and interview at baseline regarding sociodemographic characteristics, lifestyles, comorbidities and health economic data including resource use, costs and health-related quality of life (HR-QoL). Psychologists, blind to previous results, will assess dementia stage of the participants using an abbreviated Clinical Dementia Rating (CDR) scale. At 6-month follow-up, participants will complete a brief health economics questionnaire on resource use, costs and HR-QoL. To validate the accuracy of the detection tool, a subsample of 600 participants who completed the baseline will undergo a gold-standard clinical neuropsychological assessment. This subsample will participate in a 12-month follow-up, including health economics, cognitive and functional impairment tests and the CDR scale. Results will be analysed and presented by cognitive status, site, sex and multimorbidity profile. Finally, data from all stages and external sources will inform a decision model to implement a cost-effectiveness analysis of the detection tool at the national level.

The study received ethics approval in Peru (Universidad Peruana Cayetano Heredia: CONSTANCIA-CIEI-378-33-23) and in the UK (Imperial College London: ICREC/SETREC reference number 6647445). Informed consent will be obtained from participants and their study partners, considering the participant’s capacity to consent. For illiterate participants, consent will be obtained through a witnessed procedure involving study partners, with a fingerprint obtained instead of a signature. The results will be disseminated through conferences, published articles, public presentations (particularly to those involved in dementia care) and presentations or meetings with local health authorities.

The mental health first aid (MHFA) training is an evidence-based programme that is known to improve undergraduate students’ attitudes towards mental illness and confidence in helping people with mental health problems. MHFA training will be implemented at a university in Hong Kong to address growing concerns about mental health challenges among students. Given the context of a university-wide systematic MHFA training implementation, this evaluation uses an intervention logic framework to evaluate the processes and longitudinal outcomes.

A mixed-method approach will be used where the quantitative component will gather data from a review of records and a case-control study for outcome evaluation; the qualitative component will gather data from individual interviews. All first-year students from the university in the academic year 2024–2025 (ie, September 2024 to August 2025) will be enrolled in the mandatory MHFA training. The outcome evaluation will assess effectiveness through short-, intermediate- and long-term outcomes. An online questionnaire will be distributed to the students before (pre) and immediately after (post) the MHFA training. For comparison, second-year students who had not participated in MHFA training will be invited to complete the same online questionnaire. The questionnaires will be administered further to those who completed the MHFA training at 12 months (ie, academic year 2025–2026) and 24 months (ie, academic year 2026–2027) post-training to evaluate intermediate-term and long-term effects, respectively. The process evaluation explores feasibility, fidelity, adoption and the barriers and enablers to implementation.

This evaluation has been approved by the Human Research Ethics Committee of Hong Kong Metropolitan University (reference number HE-SF2024/35). The findings are expected to contribute to establishing long-term effects on mental health literacy and on the actual mental health support actions provided by participants, which goes beyond the intention to help. This evaluation would also facilitate a better understanding of the processes that need to be considered in a systematic MHFA training implementation in a university context. The findings will be disseminated in academic and public health community settings.

This project has been registered in the Open Science Framework. Fully anonymised data will be saved and subsequently made available through the following OSF registration: https://doi.org/10.17605/OSF.IO/92N5Q.

A growing number of community-dwelling older adults living alone face a range of physical, psychological and social challenges that negatively impact their well-being. Various technologies have been developed to support healthy ageing, with voice-activated technology (VAT) offering particularly promising opportunities to improve later life well-being. However, its effect on older adults living alone has not yet been systematically evaluated. Thus, this study aims to provide an evidence base for the effectiveness of VAT interventions in enhancing the physical, psychological and social well-being of older adults living alone.

We will conduct a systematic review and meta-analysis of studies examining the use of VAT interventions among older adults living alone. The eligible study designs include randomised controlled trials and quasi-experimental studies. Primary outcomes will focus on physical, psychological and social well-being. A comprehensive search will be conducted across international (PubMed, Embase, Cochrane Library, CINAHL, PsycINFO, ProQuest and Web of Science) and Korean databases (RISS, DBpia and KISS). Two reviewers will independently conduct study selection, risk-of-bias assessment and data extraction. A meta-analysis will be conducted to synthesise the effects of VAT interventions on psychological, physical and social domains of well-being.

Synthesising existing evidence, this review aims to inform the development of targeted interventions and support strategies to improve the well-being of older adults living alone. As no new data will be collected, ethical approval is not required. Findings will be published in a peer-reviewed journal to guide targeted intervention strategies and engage both academic and policy audiences.

CRD420251084621.

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.

Diabetes affects ~10% of the world’s population and is rising. Treatment costs in the UK are ~15% of the NHS budget. Diabetes-related complications can be lowered through better evidence-based clinician management and patient self-management. MyWay intelligence quotient (MWIQ) is an electronic platform that will provide clinical decision support around the diagnosis and treatment of patients with diabetes. This study evaluates the safety and clinical performance (clinical appropriateness/applicability, clinical impact and clinical usability) of MWIQ.

The system will be implemented in real time in four to seven general practitioner (GP) practices. Clinicians with diabetes expertise will be recruited as validators, who will inspect records to ensure system robustness before use, and up to 14 healthcare professionals will use and evaluate the system.

Quantitative and qualitative analyses will be triangulated to assess the MWIQ system. Assessment of clinical outcomes will be made using pseudonymised routinely collected clinical data, including adherence to quality performance indicators, diabetes diagnosis, diabetes investigations (eg, genetic testing), HbA1c, blood pressure, body mass index, cholesterol and foot risk score for the diabetes population concerned. Clinical and validator participants will also submit a weekly questionnaire, and these, along with interviews, which are scheduled during the testing process, will be analysed to provide data on the utility, safety and usability of the system.

This study was approved, 08/01/2024, by the North of Scotland Research Ethics Committee (REC), IRAS project ID: 305267, REC, reference 23/NS/0134. The study has gained confidentiality advisory group (CAG) support (reference: 24/CAG/0002), medicines and healthcare products regulatory agency (MHRA) and health research authority (27/08/2024) approvals.

Findings will be reported to (1) The funding body, (2) The participating GP practices, (3) The study PPIE group, (4) The MHRA to support a submission for recognition as a class 2 CE/UKCA marked device, (5) Presented at local, national and international conferences and (6) Disseminated by peer-reviewed publications.

ISRCTN17422256.

To develop and compare algorithms for identifying gestational diabetes mellitus (GDM) across European electronic healthcare databases and evaluate their impact on the estimated prevalence.

Multi-national cohort study using routinely collected electronic healthcare data

National and regional databases in five European countries (Norway, Finland, Italy, Spain and France), in primary and/or secondary care.

Pregnancy cohorts resulting in stillbirths or live births between 2009 and 2020, comprising 602 897 pregnancies in Norway, 507 904 in Finland, 374 009 in Italy, 193 495 in Spain and 116 762 in France.

The primary outcome was the prevalence of GDM identified using six algorithms: (1) Only diagnosis; (2) Diagnosis or prescription; (3) Two diagnoses or prescriptions (2DxRx); (4) Diagnosis including unspecified diabetes in pregnancy or prescription (DxRx broad); (5) Diagnosis excluding pre-existing diabetes in pregnancy or prescription; (6) Registration of GDM in a birth registry (BR).

The strictest algorithm (2DxRx) resulted in the lowest GDM prevalence, while the broadest (DxRx broad) resulted in the highest, except in France where it was BR. In the Nordic countries, GDM prevalence varied only slightly by algorithm; greater variations were observed in other countries. The prevalence ranged from 3.5% (95% CI: 3.5% to 3.5%) to 4.6% (95% CI: 4.5% to 4.7%) in Norway; 12.1% (95% CI: 12.0% to 12.2%) to 15.8% (95% CI: 15.7% to 15.9%) in Finland, where prevalence was much higher than elsewhere. The prevalence ranged from 1.3% (95% CI: 1.3% to 1.3%) to 5.4% (95% CI: 5.3% to 5.5%) in Italy; 1.6% (95% CI: 1.5% to 1.7%) to 6.2% (95% CI: 6.1% to 6.3%) in Spain; and 1.7% (95% CI: 1.6% to 1.8%) to 5.8% (95% CI: 5.7% to 5.9%) in France.

In this multinational study, GDM prevalence ranged from 1.3% to 15.8% depending on the algorithm and database. Nordic countries showed smaller differences in prevalence between algorithms, while the other countries showed larger variations, likely due to differences in coding practices, healthcare systems and database coverage.