Clinical documentation is a significant driver of burnout among physicians. Ambient artificial intelligence (AI) scribes, which leverage generative large language models to automate the creation of clinical notes from patient–physician conversations, are rapidly emerging as a potential solution. While these tools promise to enhance efficiency and reduce administrative tasks, concerns about the quality, accuracy and potential biases persist. There is now a need for a systematic synthesis of evidence to evaluate the impact of these technologies in clinical practice. To assess the effects of ambient AI scribes on physicians’ clinical documentation, the specific objectives are to: (1) evaluate the effectiveness of these tools on documentation, including accuracy and completeness; (2) synthesise evidence on the impact on physician efficiency after adoption, including time spent on documentation and (3) examine physicians’ satisfaction with these tools, including physicians’ perceived burden.

A systematic review of quantitative or mixed-method studies as well as preprints will be conducted. We will perform a comprehensive search of four electronic databases (PubMed, IEEE Xplore, APA PsycInfo and Web of Science, along with medRix and ClinicalTrials.gov for preprints) for empirical studies published between January 2023 and March 2026. The review will synthesise studies comparing physicians’ use of ambient AI scribes with traditional documentation approaches. Given the anticipated heterogeneity of the studies, a narrative synthesis will be employed to summarise the findings. Where common quantitative outcomes exist, effect sizes will be calculated using Hedges’ g, mean differences or risk ratios/odds ratios as appropriate. The overall quality of evidence will be assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework.

As no patient data are involved in the data collection, no ethical approval is acquired. Results will be disseminated in a peer-reviewed, open-access journal, and presented at relevant academic conferences.

CRD420251149086.

Respiratory syncytial virus (RSV) is a leading cause of hospitalisation in infants worldwide. New immunoprophylactic products, including long-acting monoclonal antibodies and maternal vaccines, have demonstrated high efficacy in prelicensure clinical trials. Understanding how these interventions perform outside controlled trials, and how viral evolution or host factors influence protection, is essential for sustaining confidence in RSV prevention programmes.

We will conduct a 5-year, test-negative case–control study among infants ≤12 months of age who present with acute respiratory illness (ARI) within a large healthcare delivery network serving a demographically diverse population. Cases will be infants testing positive for RSV by PCR, and controls will be RSV-negative infants meeting the same ARI criteria. Data will be obtained from electronic health records, structured caregiver surveys and state immunization registries to ensure accurate classification of exposures and covariates. Vaccine effectiveness will be estimated using multivariable logistic regression controlling for potential confounding. RSV-positive specimens will undergo full-genome sequencing to identify variant lineages and potential immune-escape mutations. A subset of participants will provide acute and convalescent blood samples for single-cell immune profiling to define innate and adaptive responses associated with breakthrough infection.

The study protocol has been approved by the Yale Human Investigation Committee (HIC #2000036550). Written informed consent will be obtained from all parents or legal guardians prior to participation. Study findings will be disseminated through peer-reviewed publications, scientific meetings and public repositories, with fully de-identified participant data to protect privacy and confidentiality. Viral genomic data will be shared in accordance with the National Institutes of Health Genomic Data Sharing Policy, and analytical code will be made publicly available to ensure reproducibility.

NCT06172660.

Risk reduction training for UK care home staff is limited, not standardised and challenging to implement. Virtual reality (VR) is an immersive, engaging method of education delivery that is being adopted in health and social care. VR may be an effective education tool in care homes, but this research has yet to be conducted.

The VR-CARE project aims to create a new VR risk reduction training programme for care homes that combines hand hygiene and falls prevention modules, and to evaluate this through a pilot trial to inform a future randomised controlled trial (RCT).

There are two research phases with patient and public involvement and engagement (PPIE) activities embedded throughout. Care home stakeholders are collaborating to design the training and toolkit, oversee methods, review resources for accessibility, support recruitment and ensure the project meets the needs of the workforce and positively impacts resident care.

In phase 1, we will use a mixed-methods and user-centred design approach to develop the VR training and an accompanying implementation toolkit needed to deliver it. The training will be developed and tested by 15 care home staff across three rounds to identify and inform changes that maximise usability and acceptability. We will conduct up to 20 interviews with staff from VR companies and care homes to support toolkit development.

Phase 2 is a mixed-methods pilot cluster RCT, with a waitlist control and process evaluation with up to 80 unregistered staff members from six North England care homes, to develop the measures and methods to inform a future trial. The process evaluation will generate knowledge about VR as a training mechanism in care homes. This phase will focus on the practicality of using VR, broader impacts (eg, on residents), contextual considerations and how it might be scaled up.

The University of Manchester Proportionate University Research Ethics Committee has approved phase 1 (Reference: 2025-24416-44642). We will obtain further approval before commencing phase 2.

Outputs will include user-friendly and acceptable VR risk reduction training for care homes, accompanied by an implementation toolkit adaptable for other VR training in social care settings. Materials (eg, training overviews, infographics and videos) will be developed to support uptake. Findings will be presented at conferences and published in journals. Lay summaries will be co-created with our PPIE group, and additional dissemination methods will be co-developed to broaden reach.

Indian immigrants experience significant dietary acculturation post-migration, shifting from traditional diets to more westernised eating patterns influenced by socioeconomic and environmental factors. This transition, often marked by increased processed food consumption and reduced intake of traditional staples, contributes to elevated risks of obesity and type 2 diabetes. Despite the growing Indian diaspora in Australia, Canada, New Zealand and the UK, the evidence on their dietary acculturation remains limited.

This review will adopt the Joanna Briggs Institute (JBI) methodology for scoping reviews. A three-step search strategy will be applied across databases including MEDLINE (via PubMed), CINAHL, Scopus and Web of Science. Google Scholar will be used as a supplementary search tool to identify additional relevant studies. The search will include peer-reviewed studies and grey literature published in English between 1 January 2000 and 22 May 2025. First-generation Indian immigrants of all ages will be included, while second-generation immigrants, refugee populations and studies linked to non-communicable disease interventions will be excluded. Screening will be conducted in Covidence by two independent reviewers, with discrepancies resolved by a third reviewer. Data will be extracted using a standard JBI tool, charted in tabular form, and synthesised narratively and thematically.

As this review will use published and publicly available data, formal ethics approval is not required. Findings will be disseminated through peer-reviewed publication, conference presentations and community engagement.

The Infant Gut Bacterial Study in Nigeria (INBUGS-NG) investigates how delivery mode, antibiotic exposure, feeding practices and environmental factors shape gut microbiome development and acquisition of antibiotic resistance genes (ARGs) during the first year of life in northern Nigeria.

Between February and July 2024, 90 mother–infant dyads were enrolled at a tertiary hospital in Kano city, Nigeria. This was a prospective longitudinal cohort with follow-ups at 10 scheduled time points: days 0, 1, 3, 5, 7, 14, 28, 90, 180 and 365. We also intensified stool sampling after infant antibiotic administration, enabling dense early-life sampling. To date, the cohort has contributed 480 infant stool samples, 232 maternal rectal swabs, 254 breast milk samples and 806 environmental samples (total 1772). In parallel, socio-demographic, clinical and cultural data were collected using Research Electronic Data Capture (REDCap) and household visit diaries.

Baseline data show that 84/90 mothers (93.3%) received postpartum antibiotics, and 26/90 infants (28.9%) received antibiotics within the first 3 months of life. Only 8% of infants were exclusively breastfed, with early water supplementation common. Caesarean deliveries accounted for 25% of births, and the mean gestational age was 38.5 weeks. Across the cohort, high retention was achieved, and the study has generated a unique long-read metagenomic resource from an African infant population, with analyses ongoing.

Shotgun long-read metagenomic sequencing (Oxford Nanopore) will enable strain-level and plasmid-level profiling of microbial communities and ARGs. Planned analyses include associations between early-life exposures and resistome dynamics, as well as cross-cohort comparisons with a parallel study in Pakistan. Follow-up will continue through 12 months.

Persistent postsurgical pain (PPSP) affects up to 15% of patients after major surgery, impairing physical function, quality of life and increasing risk for long-term opioid use. Current PPSP prediction models rely on static or retrospective data and fail to incorporate dynamic perioperative factors. The Personalised Prediction of Persistent Postsurgical Pain (P5) study aims to develop individualised, multimodal prediction models by integrating preoperative behavioural, psychophysical and neurocognitive assessments and high-frequency symptom monitoring.

P5 is a prospective, single-centre cohort study enrolling 2500 adults aged 18–75 undergoing major surgery at a tertiary academic hospital. Participants complete baseline surveys, cognitive testing and quantitative sensory testing preoperatively. Ecological momentary assessments (EMAs) are collected via smartphone three times per day through 30 days postoperatively, capturing pain, mood, catastrophising and medication use. Participants are assessed on postoperative day 1 and complete online surveys at 3 and 6 months, evaluating pain persistence, interference, neuropathic symptoms and related outcomes. Clinical and perioperative data are extracted from the electronic health record. The primary outcome is PPSP at 3 months. Predictive models will be developed using supervised machine learning and dynamic structural equation modelling to extract latent features from EMA data. Model performance will be assessed using area under the receiver operating characteristic curve, area under the precision-recall curve and SHapley Additive exPlanations for interpretability.

This study has received ethics approval from the Washington University School of Medicine Institutional Review Board #202101123. Informed consent is required. Results will be submitted for publication in peer-reviewed journals and presented at research conferences.

NCT04864275.

The implantable cardioverter defibrillator (ICD) is a cardiac device recommended for use to prevent the occurrence of sudden cardiac death (SCD) in post-myocardial infarction (MI) patients with reduced left ventricular ejection fraction (LVEF). The evidence informing this guidance comes from landmark trials that are now more than 20 years old. The risk-benefit profile of ICD for the contemporary target population may have changed substantially since then, which raises the question of whether there is evidence for sparing patients a procedure associated with potentially severe complications and high healthcare costs. A main part of the PRevention Of sudden cardiac death aFter myocardial Infarction by Defibrillator implantation (PROFID) project is the PROFID EHRA trial, which is supported by the European Heart Rhythm Association. PROFID EHRA is a European Union-funded, prospective, randomised, multi-centre, non-inferiority study designed to compare optimal medical therapy (OMT) alone to ICD with OMT, for post-MI patients with reduced LVEF. The study also describes economic evaluation methods to quantify the cost and health implications of using OMT alone in place of ICD implantation plus OMT in this group of patients.

The economic evaluation has been designed to conduct a pre-trial cost-effectiveness analysis (CEA) prior to the availability of trial data, followed by a within-trial cost-consequences analysis (CCA) and a long-term post-trial CEA, conducted from the National Health Service and Personal Social Service perspective in England. The pre-trial CEA uses simulation modelling informed by available evidence to assess the lifetime costs and quality-adjusted life years of OMT alone and ICD+OMT in post-MI patients with reduced LVEF at risk of SCD, as defined in the PROFID EHRA trial. The within-trial CCA is intended to summarise the health-related quality of life (HRQoL), healthcare resource use and associated costs observed during the PROFID EHRA trial follow-up period. The post-trial CEA updates the pre-trial model by incorporating contemporary evidence about the HRQoL and costs observed during the trial and the occurrence of those events and outcomes accruing during the trial follow-up period and projecting them into the expected lifetime of the patients. Sensitivity analyses are performed to assess the robustness of the CEA results with respect to both model assumptions and uncertainty in the value of the model input parameters. Finally, a value of information analysis will identify the key drivers of uncertainty surrounding the model conclusions regarding the optimal treatment strategy, establishing if further research may be required.

The PROFID EHRA trial, under legal sponsorship of Charité—Universitätsmedizin Berlin, Germany, received its first ethics approval by the Medicine Research Ethics Committee of the La Paz University Hospital in Madrid, Spain (reference number LHS-2019-0209). Before including patients, for all participating study centres, the required local, central and/or national ethical approval has to be obtained. As of the date 13 November 2025, at least one participating study centre in the following countries has received ethical approvals from relevant ethics committees: Austria, Belgium, Czech Republic, Denmark, France, Germany, Great Britain, Hungary, Israel, the Netherlands, Poland and Spain. Results will be shared with the general public through various media channels and additionally with healthcare professionals and the scientific community through scientific meetings, conferences and publications.

NCT05665608.

Chronic dyspnoea is a prevalent symptom, and primary care is ideally placed to identify and manage it. However, chronic dyspnoea is under-reported by patients and can be a diagnostic dilemma for practitioners. A fully automated system of patient screening, coupled with a clinical decision support system (CDSS) that uses a validated and evidence-based dyspnoea algorithm, may improve detection, diagnosis and management of the condition. There is currently no CDSS validated for chronic dyspnoea diagnosis and management in primary care in Australia. The objectives of this study are to assess the clinical impact of a CDSS for chronic dyspnoea in primary care. We hypothesise that the use of the CDSS will lead to a clinically significant improvement in patient-reported dyspnoea scores, reduced time to diagnosis and healthcare costs at 12 months compared with standard care.

The BREATHE study is an open-label, cluster-randomised controlled trial of standard of care compared with a CDSS. General practices (n=40) in metropolitan, regional/rural and rural/remote settings will be recruited and randomised equally to pre-screening for chronic dyspnoea and usual standard-of-care management or pre-screening and CDSS-guided management. The CDSS includes an algorithm derived from a robust data and clinical knowledge model and incorporates evidence-based recommendations for the assessment and management of chronic dyspnoea. It is integrated into general practice medical software systems, fitting in the workflow of general practitioners (GPs). Eligible patients will be ≥18 years old and will have previously consented to receive SMS communication from their practice. In-scope patients will receive an automated text message prior to their GP appointment and will be screened for chronic dyspnoea (≥4 weeks). Patients identified with chronic dyspnoea will be invited to participate in the BREATHE study and followed up for 12 months. The primary outcome is improvement in the Dyspnoea-12 (D-12) score from baseline to 12 months, measured by the Dyspnoea-12 (D-12) questionnaire. Secondary outcomes include disease-specific questionnaires to assess changes in clinical outcomes, time to final diagnosis, quality of life, healthcare utilisation and costs incurred to patients.

The trial is registered at ANZCTR (ACTRN12624001451594). ANZCTR is a primary registry that meets the requirements of the ICMJE and is listed on the ICTRP Registry Network.

The study protocol has been approved by the University of New South Wales Human Research Ethics Committee (HREC) (iRECS6645) and complies with the National Health and Medical Research Council ethical guidelines. Participating practices and each GP will provide written, informed consent. All patients being screened will provide electronic informed consent. Results of the study will be disseminated through various forums, including peer-reviewed publications and presentation at national and international conferences. Following the study, participating practices will be provided with a summary of the findings of the study, together with a full copy of any publications and a plain language statement for participants, which will be made available in the practice reception area.

Effect size and event rate estimation is necessary for sample size calculation in randomised clinical trials. Overestimation of the effect size and event rate can lead to inadequately powered studies and increased probability of false negative results. This is common in trials involving critically ill patients. However, such overestimation has not been systematically evaluated in trials involving neurocritical care. We aimed to conduct a systematic review of published randomised clinical trials involving critically ill neurological patients, to determine the accuracy of effect size and event rate estimation.

We will review randomised clinical trials involving adult critically ill neurological patients that were published from 2015 onwards in selected clinically useful and high-impact journals. We will include randomised clinical trials reporting a binary or time to event outcome, using two study groups, and a superiority design testing the efficacy of diagnostic, monitoring, therapeutic or process interventions. All eligible studies must report an estimated event rate in the control group and estimated effect size. All relevant studies will be identified through database searches. All study selection and data extraction will be conducted by two independent reviewers. We will use a random-effects model for pooling data. This review will be conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting guidelines. Accuracy of effect size and event rate estimation will be evaluated by comparing the estimated and observed values. The association between the accuracy of the individual randomised clinical trial effect size and event rate estimation and rejection of the null hypothesis will be evaluated using logistic regression analysis. Multivariable linear regression analysis will be used to explore the factors associated with accuracy of effect size and event rate estimation. In addition, we will perform subgroup analysis by impact factor of the published journals, sample size of the studies and risk of bias.

As this systematic review will use data from previously published studies, it does not require ethics approval. Findings of this systematic review will be published in a peer-reviewed journal and will be presented at specialty-based conferences. The study will be included in the higher degree research thesis of the primary author.

CRD420251106394.

To elicit the benefits of shared decision-making to doctors who are champions of this approach.

A qualitative interview study that used practical thematic analysis.

We identified a purposive international sample of doctors in active clinical practice who were recognised champions of shared decision-making, working in various clinical disciplines.

24 doctors in active clinical practice were interviewed; 14 were male and 10 were female; 20 had been in clinical practice for over 10 years (range 1–30). 12 practised in North America, 10 in Europe, 1 in South America and 1 in Asia; 4 doctors worked in internal medicine, 4 in primary care, 5 in surgery, 3 in paediatrics, 3 in oncology and 1 in each of the following disciplines: emergency medicine, palliative care, geriatrics, physical medicine and rehabilitation, anaesthesiology, and cardiology.

This selected sample of doctors consistently reported that shared decision-making provided benefits to themselves, their patients and their teams. Shared decision-making reinforced and enhanced their self-identity as ethical professionals, supporting patient autonomy, increasing their professional fulfilment and reducing their risk of burnout. These intrinsic benefits accompanied reports of other consequential benefits, namely, patients’ achieving better-informed, preference-sensitive decisions, a higher likelihood of improved patient outcomes, improved efficiency and team function. The doctors viewed the approach as providing connectedness, shared responsibility resulting in a lighter burden, acting as a buttress against moral injury and the emotional strain of clinical work and, where relevant, mitigation against becoming the second victim of a bad or unexpected outcome.

Doctors who champion shared decision-making report significant benefits to themselves and their patients. These benefits have not been widely reported, which has implications for motivating doctors to adopt shared decision-making. Instead of addressing presumed gaps in communication skills, it might be better to highlight the positive impact on professional fulfilment and the protective effect of shared decision-making.

Our primary objectives were (1) to develop and validate an administrative data algorithm for the identification of hand trauma cases using clinical diagnoses documented in medical records as the reference standard and (2) to estimate the incidence of hand trauma in a universal public healthcare system from 1993 to 2023 using a population-based research cohort constructed using a validated case identification algorithm.

A population-based retrospective validation study.

Ontario, Canada, from 2022 to 2023 (validation) and from 1993 to 2023 (estimation).

Our reference standard was the known hand trauma status of 301 patients (N=147 with hand trauma) who presented to an urban tertiary-care hand trauma centre in Toronto, Ontario.

(1) The sensitivity, specificity, positive and negative predictive values of the optimal algorithm to identify hand trauma using provincial health administrative data and (2) age-standardised and sex-standardised incidence rates of hand trauma among men and women, by age, and by area of patient residence.

The optimal algorithm had a sensitivity of 73.8% (95% CI 66.6% to 81.0%), specificity of 80.1% (95% CI 73.8% to 86.5%), positive predictive value of 78.1% (95% CI 71.2% to 85.0%) and negative predictive value of 76.1% (95% CI 69.5% to 82.7%). Over the study period, the age-standardised and sex-standardised incidence of hand trauma increased from 384 to 530 per 100 000. The greatest increase was observed in males and individuals aged 0–19 and 80+, with higher incidence rates in Southern compared with Northern Ontario.

Our algorithm enabled identification of hand trauma cases using health administrative data suitable for population-level surveillance and health services research, revealing a rising burden of hand trauma from 1993 to 2023. These findings can support improved surveillance, resource allocation and care delivery for this public health problem.

Polysubstance use (PSU), particularly opioid-involved and stimulant-involved PSU, is a growing issue in the USA. PSU increases the risk of negative health consequences, including infectious diseases, worsening physical and mental health conditions, and overdose-related deaths. These consequences occur in the context of varying health risk behaviours, substance-related preferences, and treatment engagements among people with PSU. To inform improvements in prevention, harm reduction, and substance use disorder (SUD) treatment, additional research is needed to comprehensively understand the current context and drivers of PSU preferences, motivations, and behaviours.

Herein, we describe the protocol for a prospective cohort study designed to capture detailed patterns, profiles, and trajectories of PSU, with the aim of comprehensively examining the drivers of PSU behaviours and SUD treatment utilisation. Adults (ages 18–75; n=400) who engage in PSU will be recruited from healthcare institutions, an established participant database maintained by an adjacent SUD research team, and online advertisements. Study assessments will capture dynamic patterns, choice preferences, and motivators of PSU via behavioural economic (BE) measures, detailed Timeline Follow-Back (TLFB) interviews, and self-administered surveys. The assessment timeline will include a baseline survey and TLFB interview, weekly TLFB interviews for 4 weeks post-baseline, and follow-up surveys and TLFB interviews at 4-, 8-, and 12-months post-baseline.

The study is funded through the National Institutes of Health Helping to End Addiction Long-term (HEAL) initiative and was approved by the University of Michigan Medical Institutional Review Board. Findings will be disseminated to academic, clinical, and community partners through the Michigan Innovations in Addiction Care through Research and Education programme. Results from this study will inform actionable and practical insights relevant to the delivery of personalised care in the context of PSU.

This study examined factors associated with the use of Indonesia’s National Health Insurance (NHI) among its beneficiaries in Maluku province.

Cross-sectional study.

The individual-level data were derived from the 2021 Social Health Insurance Sample Data. National health reports of Indonesia were used to provide the district-level variables. We performed multivariable logistic regression analyses to identify factors associated with NHI use among its beneficiaries in Maluku province.

Data were collected from 31 517 NHI beneficiaries registered in Maluku.

The primary outcome was the use of NHI insurance when accessing healthcare services (yes/no).

Only 14.79% of NHI beneficiaries in Maluku had ever used their insurance for healthcare services. Individual factors associated with higher NHI use included being under 60 years, females (adjusted OR (aOR)=1.29, p

Strengthening primary healthcare accessibility, improving the distribution of healthcare workers and addressing socioeconomic and geographical disparities are essential to ensure that the NHI scheme achieves equitable use across all regions in Maluku and other areas with similar settings.

Being exposed to adverse psychosocial working conditions contributes to poor mental health in young workers. This study explores whether psychosocial work adversities are a necessary condition for work-related emotional exhaustion in young workers.

Data from the ‘Netherlands Working Condition Survey 2021’ was used. By applying a novel method called Necessary Condition Analysis, we tested two psychosocial work adversities as necessary conditions for high work-related emotional exhaustion in young workers: (1) a composite score of high job demands and low job resources and (2) a composite score of high job demands. Additionally, we tested whether the threshold for job demands as a necessary condition for high work-related emotional exhaustion differed for young workers with low versus high resources.

Secondary data analysis on a national working population-based survey.

The sample included 5791 young workers in the Netherlands (aged

Work-related emotional exhaustion.

A high level of the composite on job demands and job resources is necessary for a high level of work-related emotional exhaustion in young workers (effect size=0.11, p

Both psychosocial work adversities were necessary conditions for high work-related emotional exhaustion in young workers. The necessity threshold for job demands was higher for young workers with high job resources, compared with the group with low resources. This indicates that removing psychosocial work adversities and ensuring the presence of job resources might contribute to the prevention of high work-related emotional exhaustion in young workers.

To evaluate adherence to National Health Service (NHS) patient registration ID guidelines among General Practitioners’ (GP) practices.

A mystery shopper study, including website reviews and phone calls.

Rural and urban parts of the United Kingdom’s West Midlands.

85 randomly selected GP practices.

In January–April 2024, GP’s websites were reviewed before phone calls in which our ‘mystery shopper’ was asked to register without photo ID and proof of address.

Of 85 GP practices, 60 (71%) breached NHS guidance either online or over the phone, with only 25 (29%) consistently following NHS guidance. Phone calls to rural (vs urban) GP practices were more likely to yield refusal of registration without photo ID and proof of address, despite rural (vs urban) GP practices making similar statements online. During some phone calls, practices sought to negotiate a compromise by requesting less robust ‘documentation’, such as an addressed parcel.

GP practices commonly refuse registration to people without photo ID or proof of address, thus creating ‘sludge’ and undermining access to healthcare especially for poor, vulnerable patients, including immigrants. Changing GP practices’ websites would not address this problem if erroneous information is still provided over the phone. GPs and practice managers should ensure that all staff follow NHS guidance to allow registration without these documents.

Stress is a major health issue in contemporary society, and mindfulness-based approaches reduce stress and anxiety but face practical barriers to consistent practice; this protocol evaluates a Virtual Reality (VR)-based observation meditation programme with an artificial intelligence (AI) coach (‘Otti’) that delivers real-time empathic, tailored prompts to support present-focused attention and emotion regulation in university students in the United States. A single-centre randomised controlled trial in Pennsylvania will assess immediate psychophysiological effects and user acceptability after a single 15 min session following a standardised Stroop stressor in a university laboratory setting.

An a priori power analysis (f=0.25, α=0.05, power=0.80) supports recruitment of 34 students (n=17 per group) in a single-centre randomised controlled design comparing AI-coached VR observation meditation to a no-treatment leisure control within a 30 min visit. Participants complete pre-intervention surveys Perceived Stress Scale-10 (PSS-10), Depression Anxiety Stress Scales (DASS-21), State–Trait Anxiety Inventory (STAI-State, STAI-Trait) and baseline heart rate/Heart Rate Variability (HRV) via smartwatch, undergo the 15 min intervention or control, then complete postintervention surveys and repeated heart rate/HRV recording; effects will be tested using repeated-measures analysis of variance, with heart-rate data exported and preprocessed per the prespecified plan. Primary outcomes include perceived stress (PSS-10), emotional state (DASS-21, STAI-State, STAI-Trait), physiological stress response (heart rate/HRV) and participant satisfaction via a structured postintervention survey (usability, perceived effectiveness, comfort).

The study received IRB approval from The Pennsylvania State University Institutional Review Board (PSU CATS IRB: STUDY00025978; ClinicalTrials.gov: NCT06704282), and all participants will provide written informed consent prior to procedures. Findings will be disseminated via open access publication, conference presentations and stakeholder-focused briefs, with an anonymised primary-outcome dataset available on reasonable request in line with BMJ Open policies and Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)/International Committee of Medical Journal Editors (ICMJE) guidance.

NCT06704282.

Patients with acute psychiatric symptoms are often referred to the emergency department (ED) for medical evaluation to exclude medical causes before psychiatric admission. The absence of a prospectively validated medical screening tool leads to wide practice variation. This study aims to develop a new, evidence-based and consensus-based medical screening tool through a collaborative, interdisciplinary, international Delphi approach.

This modified Delphi study will include representatives from emergency medicine and psychiatry societies across four continents, as well as patient representatives with prior experience of medical screening in the ED. A minimum sample size of 24 participants is planned to account for potential dropouts. The Delphi procedure consists of four rounds. Round 1 will present current evidence and identify key items for the new medical screening tool. Round 2 will evaluate and refine statements from Round 1. Round 3 will seek consensus on the variables to be included in a medical screening tool. In Round 4, hypothetical clinical vignettes will be used to assess the agreement on the recommendations of the newly developed medical screening tool in order to test for content and construct validity. Surveys will be conducted via Research Electronic Data Capture (REDCap), with participants rating statements on a 6-point Likert scale. Response stability will be evaluated using the intraclass correlation coefficient, and consensus defined as ≥80% agreement. Results will be reported according to the ACcurate COnsensus Reporting Document guidelines and the Guidance for Reporting Involvement of Patients and the Public 2 short form.

The Ethics Committee of Northwestern and Central Switzerland exempted the project from committee approval under the Human Research Act on 11 September 2024. Written consent will be obtained from all participants. Results of this study will be summarised as a medical screening tool which will be validated in a prospective, multicentre study in a second step.

NCT06936826.

Infants born to pregnant women living with HIV (WLHIV) are at greater risk for morbidity and mortality and may also have poorer developmental outcomes as compared with infants who are not exposed to HIV. Nutrition interventions in pregnancy may affect developmental outcomes.

This study evaluated the effect of maternal vitamin D supplementation on infant development outcomes.

We conducted a secondary analysis of a randomised, triple-blind, placebo-controlled trial of maternal vitamin D supplementation from June 2015 to October 2019.

Antenatal care clinics in Dar es Salaam, Tanzania.

Pregnant WLHIV and their offspring.

Daily 3000 IU vitamin D₃ or placebo supplements taken during pregnancy and lactation.

Infants were assessed for cognitive, language and motor development at 1 year of age with the Caregiver Reported Early Development Instruments (CREDI).

A total of 2167 infants were eligible, and 1312 of them completed CREDI assessments at 1 year of age. Vitamin D supplementation had no effect on overall CREDI z-scores (standardised mean difference (SMD) 0.03, 95% CI –0.09, 0.15, p value 0.66). There was also no evidence of a difference between vitamin D and placebo groups in language (SMD 0.06, 95% CI –0.08, 0.21, p value 0.40), motor (SMD 0.02, 95% CI –0.09, 0.14, p value 0.69) or cognitive domain z-scores (SMD 0.05, 95% CI –0.08, 0.17, p 0.48).

Maternal vitamin D supplementation during pregnancy and lactation did not affect infant development outcomes.

ClinicalTrials.gov identifier: NCT02305927.

Food insecurity is increasing in the UK, impacting choice and diet quality. The current means-tested free school meals (FSM) policy was put in place to address dietary inequalities and food insecurity in school children. In secondary schools, approximately 20% of students who are eligible and registered do not take their FSM. Working across a range of schools that have variable levels of FSM uptake, this study aims to evaluate the effectiveness and cost-effectiveness of the current means-tested FSM policy in UK secondary schools on diet and food insecurity outcomes, understand what factors are associated with uptake and test the potential impact of any proposed policy change.

Secondary schools (n=32) in both Northern Ireland and the Midlands region of the UK are being recruited into the study. Data will be collected from school staff, governors, students and parents via questionnaires, as well as observational data of school eating environments. Qualitative data will be collected in selected case study schools (n=6–8). Multilevel modelling will be undertaken to evaluate the association between FSM uptake and fruit and vegetable intake, overall diet quality and food insecurity in all students. Economic evaluation will be conducted using a cost–utility approach. The effect of policy change will be modelled and school factors associated with FSM uptake explored using multiple methods.

Ethical approval has been obtained from Queen’s University Belfast Faculty of Medicine, Health and Life Sciences Research Ethical Committee (MHLS 23_55). Findings will be disseminated to key national and local agencies, to schools through reports and presentations, and to the public through media and open access publications.

Children with medical complexity (CMC) are a subset of children with special healthcare needs, defined by high healthcare utilisation, severe single or multisystem organ dysfunction, and in many cases, reliance on medical technology. In the emergency care setting, known challenges for this population include poor quality of care, avoidable admissions and high caregiver and provider burden. While experts and professional societies recommend emergency care planning tools to address these concerns, evidence to support effectiveness and implementation of such tools is lacking. Through a human-centred design approach, we recently engaged key partners to create and optimise an emergency care action plan (ECAP) for infants with medical complexity. Here, we describe the protocol for a pilot type 1 hybrid effectiveness-implementation randomised controlled trial (RCT) for infants with medical complexity aimed to evaluate ECAP effectiveness and implementation.

Infants with medical complexity and their caregivers will be randomly assigned to the intervention group (ECAP) or control group (standard care) in a pilot type 1 hybrid effectiveness-implementation RCT. The primary outcome is number of inpatient hospital days for infant participants. Additional effectiveness outcomes include perceived avoidance of emergency department (ED) visits, healthcare costs, caregiver stress and self-efficacy. Preliminary implementation outcomes include acceptability, feasibility, appropriateness and usability, as well as contextual barriers and facilitators to reach, adoption and implementation. Key partners, including caregivers of CMC and healthcare providers, will be engaged throughout the implementation of the ECAP and execution of the trial.

This study was approved by the University of Vermont Institutional Review Board (STUDY00002937). Findings will be disseminated through peer-reviewed publications, conference presentations, and focus groups and interviews with key stakeholders.

NCT06444282.