BMJ Open

Background: Medical Emergency Teams (METs) are intended to provide early expert assessment and treatment for deteriorating hospitalised patients. However, MET activation may occur only after prolonged physiological deterioration. Potential explanations include uncertainty about activation criteria, professional hierarchy, departmental culture, perceived pressure to manage deterioration without help, fear of criticism, and concerns that activation may reflect poorly on professional competence. This study aims to identify modifiable barriers and facilitators to timely MET activation among healthcare professionals caring for hospitalised adults. Methods: This multicentre cross-sectional web survey will be conducted sequentially at four Swiss hospitals: two cantonal hospitals and two tertiary university hospitals. Eligible participants are physicians, nurses, nurses in training, physiotherapists, occupational therapists, and speech and language therapists involved in the care of hospitalised adult patients in areas where MET activation may occur. Staff working primarily in paediatrics, emergency medicine, anaesthesia, intensive care, operating theatres, recovery areas, or outpatient care, and MET members themselves, are excluded. The German-language questionnaire was developed from relevant items identified in published MET and rapid response system surveys and was informed by the revised 14-domain Theoretical Domains Framework (TDF). The TDF was used to assess the theoretical breadth of the candidate item pool and to ensure coverage of all domains judged relevant to timely MET activation. Two physician investigators independently mapped candidate items to the single TDF domain judged most appropriate; disagreements were resolved by consensus. All 14 TDF(v2) domains were judged potentially relevant to the target behaviour, and additional items were developed when relevant domains were not adequately represented. The questionnaire was pilot tested by physicians and nurses. The four prespecified primary outcomes comprise one proximal self-reported behavioural indicator - non-activation despite fulfilment of MET criteria - and three potential determinants of timely activation: perceived pressure to avoid activation, concern that activation may reflect poorly on professional competence, and absence of a departmental culture supporting immediate activation. These outcomes were specified in the protocol and statistical analysis plan before inspection of the pooled multicentre results. The primary professional comparison is physicians versus nurses. Ordinal logistic regression will adjust for hospital, years of professional experience, clinical area, and previous personal MET activation. Secondary outcomes will be analysed descriptively and exploratorily. No comparison by MET maturity will be undertaken. Ethics and dissemination: The project was classified as research outside the scope of the Swiss Human Research Act. Site-specific ethics determinations and institutional endorsements will be reported. Participation is voluntary. Responses are confidential rather than fully anonymous because optional contact details may be entered in the same survey record. Results will be disseminated through a peer-reviewed publication, presentations, and aggregated feedback to participating hospitals. Registration: Because data collection has already been completed at one hospital, the registration will be described as a prospective registration of the pooled analysis rather than a fully prospective preregistration.

Abstract Introduction: Diarrheal diseases and acute respiratory infections (ARI) disproportionately affect young children and families facing disadvantages at the individual, household, and neighborhood level. This unequal burden especially impacts children in low-and middle-income countries, such as Nepal. Data limitations impede the ability to understand children's illness episodes and treatment trajectories across the course of early childhood and their relationship to household- and neighborhood-level social determinants of health. The Chitwan Valley Family Study (CVFS) is a 30-year panel study providing a wealth of information about household- and neighborhood-level social determinants in Southern Nepal. Drawing on a cohort of young children in CVFS households, this study will measure incidents of acute illness among children under five and leverage existing data from the panel study to understand how intergenerational disadvantages, place, and other social determinants affect the frequency and duration of childhood illness and subsequent healthcare utilization. Methods and Analysis: This study will use daily symptom diaries to track children's illness symptoms (diarrhea, fever, cough, runny nose, difficulty breathing or wheezing, fatigue, loss of appetite) over the course of a year. Mother respondents will complete a baseline interview, daily symptom diaries, and a weekly phone interview with a trained interviewer to describe the prior week's symptoms and, in the case of any symptoms, healthcare utilization, treatment, expenditures, and related information. All eligible children aged 3-59 months may participate in two waves of 52 weeks of data collection. We will measure the frequency and duration of diarrhea and ARI, healthcare utilization outcomes, socio-economic status, and distance to healthcare facilities, then merge these measures with prior CVFS data related to parents' childhood circumstances, health facility characteristics, and neighborhood characteristics. Ethics and Dissemination: We received IRB approval from the Nepal Health Research Council and the University of Michigan. Informed consent will be obtained from respondents for all aspects of data collection. Identifying information will be restricted to the data collection team in Nepal and stored separately from survey data. Interviewers will check that all children with danger signs identified according to WHO/UNICEF Integrated Management of Childhood Illness clinical guidelines have received adequate treatment; a study nurse will follow up and refer those who have not. We will disseminate study findings to respondents, local partners, and nationally in Nepal, as well as in academic journals and at conferences. Datasets will be available for public and restricted-use through the Data Sharing for Demographic Research program at the Inter-university Consortium for Political and Social Research at the University of Michigan.

Introduction Trials investigating hypofractionated radiotherapy in carcinoma cervix have demonstrated an increased risk of acute gastrointestinal toxicity. Patients with node negative disease have a very low risk of pelvic nodal relapse, a dose painting approach integrating differential doses to the primary and elective nodal clinical target volumes may allow safe hypofractionated radiotherapy by reducing the acute gastro-intestinal toxicity. Methods and Analysis Patients with Human Papillomavirus (HPV) associated squamous cell carcinoma who have no pelvic nodal involvement as documented on PET CT and MRI will be eligible. Patients will be randomly allocated to receive standard whole pelvic radiotherapy (CRT) covering the primary clinical target volume (CTVp) and the nodal clinical target volume (CTVn) to a dose of 45 Gy (25 fractions, 1.8 Gy per fraction) with concurrent weekly cisplatin at a dose of 40 mg/m2 weekly for five cycles. In the experimental arm (HDRT), a dose of 42.5 Gy (2.125 Gy per fraction) and 36 Gy (1.8 Gy per fraction) will be delivered in 20 fractions to the CTVp and CTVn respectively. Concurrent cisplatin will be delivered at a dose of 50 mg/m2 weekly for four cycles. The primary objective will be to compare the proportion of patients with grade 2 or higher acute gastrointestinal toxicity (nausea, vomiting and diarrhea). Secondary outcomes will include disease free survival, quality of life and late toxicity. The primary statistical analysis will be reported on the intention-to-treat population. The primary outcome will be analysed using a covariate adjusted log binomial model to compare the relative risk of grade 2 or higher acute gastrointestinal toxicity. We assume that HDRT will reduce the toxicity rate from 35% to 21% (14% absolute risk reduction). Using an asymmetric two-sided group sequential design with three planned interim analyses, the target sample size is 274 patients for 80% power with a 5% (1-sided) type I error. Ethics and dissemination The trial will be initiated at the participating centers after institutional review board approval at the respective centers. All patients will provide written informed consent. The results will be presented in peer reviewed literature as well as academic conferences. Trial Registration The trial has been prospectively registered in the clinical trial registry of India.

Background Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and post-COVID condition are complex, debilitating illnesses characterized by persistent fatigue and post-exertional malaise. Recovery is uncommon without targeted intervention; however, emerging clinical reports suggest that a subset of patients experience full resolution of symptoms after engaging in mind-body approaches. Patient perspectives on these interventions are divided, and qualitative evidence exploring successful recovery pathways is rare. This protocol outlines a study to investigate the contextual factors and patient-constructed explanations surrounding full recovery from ME/CFS or post-COVID condition using mind-body approaches. Methods and analysis We will employ a qualitative descriptive design rooted in a constructivist paradigm. Purposive and snowball sampling will be used to recruit approximately 20 adults from established infection-associated fatigue networks who self-report full recovery (lasting three months or more) from ME/CFS or post-COVID condition following a mind-body approach. Data will be collected through semi-structured interviews conducted via Zoom, and investigator reflexivity will be reported. Demographic information, including comorbidities, will be documented to contextualize the sample. Data will be analyzed inductively using reflexive thematic analysis. To ensure research rigor and reporting transparency, the study will adhere to the 15-point checklist of criteria for good thematic analysis proposed by Braun and Clarke. Dissemination We will publish our findings in a peer-reviewed, open-access journal and present at relevant academic conferences. A lay summary of the results will also be shared directly with participating patient recovery networks.

This study protocol combines clinical simulations with climatic chamber experiments, to evaluate 1) the impact of heat stress on hospital nurses physiological strain, physical and mental fatigue, vigilance, and clinical performance; and 2) the efficacy of a practical cooling intervention (i.e. electric fan) in mitigating the negative impact of heat stress. UK-based, registered adult nurses working in hospital settings will be recruited to partake in a repeated-measures cross-over design study, consisting of five separate 3-hour experimental sessions simulating clinical work, and taking place within a climatic chamber at Southampton General Hospital (UK). Sessions will differ by ambient temperature and cooling intervention as follows: 1) control (CTR; 18{degrees}C, 50% relative humidity [RH]); 2) warm (WARM; 26{degrees}C, 50%RH); 3) warm with electric fan (WARM+FAN; 26{degrees}C, 50%RH); 4) hot (HOT; 34{degrees}C, 50%RH); 5) hot with electric fan (HOT+FAN; 34{degrees}C, 50%RH). This study has been registered on a publicly accessible clinical trial registry (ISRCTN45793399). During each session, participants will first complete a standardised fatigue-induction protocol simulating shift work (i.e. low-intensity cycling with cognitive tasks); followed by a simulated hospital ward round involving six simulated patients and two simulated cardiac arrest scenarios. Nursing cognitive and physical performance will be assessed using a standardised observational assessment battery, along with objective cardiopulmonary resuscitation (CPR) performance metrics. Physiological responses will be assessed by monitoring changes in core temperature (Tcore), skin temperature (Tskin), heart rate, and whole-body sweat loss (WBSL). Fatigue and vigilance will be measured using the Swedish Occupational Fatigue Inventory (SOFI) and Brief Psychomotor Vigilance Task (PVT-B), respectively. Baseline (i.e. prior to fatiguing protocol) to post simulation changes in 1) vigilance assessed via the PVT-B (i.e. a determinant of role-specific cognitive performance); 2) CPR quality score (i.e. a determinant of role-specific physical performance); and 3) Tcore (i.e. a determinant of thermo-physiological state); will be analysed using linear mixed models to determine the effects of ambient temperature and cooling intervention on nurses clinical and physiological performance. By providing a controlled methodological framework for assessing the effects of heat exposure on hospital nurses physiological, perceptual, and clinical performance, this study will provide empirical evidence on air temperature-related changes in nursing performance and physiological strain and the role of cooling interventions in modifying these responses. This will support the development of evidence-based climate adaptation strategies to protect healthcare staff wellbeing and maintain patient safety during periods of extreme heat.

Background: Qualitative research provides insights into human behavior, perspectives, and lived experience. While existing standards like the Consolidated Criteria for Reporting Qualitative Research (COREQ) have improved transparency and rigor, the integration of large language models (LLMs) into qualitative research introduces new challenges for not covered by current guidelines. LLMs transform analytic processes and blur the line between human interpretation and algorithmic text generation, raising concerns about transparency, authorship, and epistemic trust. The here presented COREQ+LLM guideline extends COREQ to establish comprehensive reporting standards for LLM use in qualitative research. Methods: The study followed the EQUATOR Network's guideline development framework in two phases: (1) a systematic scoping review to identify best practices for reporting LLM use in qualitative research, and (2) a Delphi consensus process with international experts in qualitative research, AI, medicine, ethics, and journal editing to develop a comprehensive reporting checklist. Findings: The scoping review identified 149 studies relevant for full-text review. From this literature, 29 preliminary reporting items were extracted. In the first Delphi round, international experts (N=141) assessed the items' relevance. 20 items were accepted for inclusion in the guideline (>75% agreement); however, four required reevaluation in the second round, five underwent wording revisions, and six new items were proposed. In the second Delphi round (N=115; retention rate 82%), one was excluded, while four items still lacked consensus. Remaining items were discussed in a virtual consensus conference with nine representatives of the expert panel, resulting in the inclusion of two and the exclusion of two others. The final checklist comprises 31 items grouped into seven categories, serving as an extension of the original COREQ checklist. Interpretation: COREQ+LLM offers structured, consensus-based guidance to enhance transparency, reproducibility, and methodological rigor in qualitative research using LLMs. Its adoption will support researchers, reviewers, and editors in maintaining trust and scientific integrity.

IntroductionFalls are a major cause of injury-related morbidity, mortality, and healthcare utilisation among older adults, with the greatest burden occurring in those aged [≥]80 years. Multicomponent exercise programmes that include balance and resistance exercises reduce falls, whereas the effect of resistance training delivered as a standalone fall-prevention intervention remains uncertain. Existing resistance-training trials have generally been small, underpowered for fall outcomes, and have produced inconsistent findings, despite reduced muscle strength being an important modifiable risk factor in the oldest old. The resistance training prescription used in these studies has not always aligned with recommendations for optimal strength adaptations in terms of intensity or progressive overload, which may explain this uncertain efficacy. Therefore, this study aims to determine whether 12 months of high-intensity progressive resistance training reduces fall rates in community-dwelling adults aged [≥]80 years with reduced muscle strength. Methods and analysisThis single-centre, randomised controlled trial conducted in Trondheim, Norway, includes 241 community-dwelling adults aged [≥]80 years with reduced muscle strength. Participants are randomly assigned (1:1) to either standard care with written physical activity guidance or a twice-weekly high-intensity progressive resistance training intervention for 12 months. The primary outcome is the rate of falls over 12 months. Secondary outcomes include time to first fall, fall-related injuries, muscular function, physical performance, balance, body composition, cardiometabolic health, cognition, and participant-reported outcomes. Cost-effectiveness is assessed from a healthcare perspective over the 12-month intervention period using costs and quality-adjusted life years. Analyses follow the intention-to-treat principle, using negative binomial regression for the primary outcome. The first participant was included on 30 March 2023, and the last participant was included on 29 September 2025. The 12-month intervention period is expected to be completed by September 2026. Ethics and disseminationThe study has received approval from the Regional Committee for Medical and Health Research Ethics in Norway (REK; reference number 462261). All participants provided written informed consent before participating. Findings will be shared via peer-reviewed publications, conference presentations, and communication with stakeholders and the public. Trial registration numberClinicalTrials.gov (NCT05691166), registered 11 January 2023. Available at: https://clinicaltrials.gov/study/NCT05691166

Abstract Objectives To conduct a Delphi process to inform an international, consensus definition of manuscript peer review. Design Three-round Delphi consensus study including two surveys and one virtual consensus meeting. Peer review features identified through a prior scoping review were rated on a 5-point Likert scale in Rounds 1 and 2 and voted on using include, exclude, and abstain options in Round 3. Consensus was defined as [≥]80% agreement. Setting International experts representing interest holders affected by manuscript peer review across the fields of biomedical, health, and social sciences, economics, and healthcare-related industries. Participants Round 1 participants were purposively recruited via email from corresponding authors of articles included in the preceding scoping review. Round 2 participants were those who completed Round 1. Round 3 participants were purposely selected to address gaps in representation from earlier rounds, with attention to diversity of perspectives and equity-relevant characteristics informed by PROGRESS-Plus (e.g., geographic location, gender, race/ethnicity, occupation, and socioeconomic context). Participants were required to communicate in English. Main outcome measures Consensus on the terminology, scope, characteristics, functions, processes, and reviewer characteristics that should inform a definition of manuscript peer review. Results Across the three rounds (N=143, 109, and 16 participants, respectively), 44 peer review features across six domains (Characteristics, Function, Motivation, Assessment, Process, and Challenges) and six peer reviewer characteristics met the consensus threshold for inclusion. Consensus was also reached on terminology to describe manuscript peer review and the peer review workflow. Results were synthesized into a final conceptualization of manuscript peer review, consisting of one definition and eight pillars.The consensus definition is: Manuscript peer review is a structured process by which human reviewers assess scholarly manuscripts, with the aim of improving the quality and trustworthiness of published research in line with norms of reciprocity to the research community. The eight pillars characterize manuscript peer review and are as follows: Principled, Constructive, Timely, Transparent, Professional, Quality, Confidential, and Pluralistic. Conclusions This three-round international Delphi established a consensus-based, normative conceptualization of manuscript peer review as a distinct, human-led process to improve the quality and trustworthiness of scholarly research. The resulting definition and eight pillars may provide a shared foundation for research, evaluation, education, and improvement across publishing contexts while allowing operational features to remain adaptable.

Purpose: Rapid Assessment of Avoidable Blindness (RAAB) surveys are widely used to estimate the prevalence and causes of blindness and vision impairment among adults aged 50 years and older. We examined how far estimates of eye-care need depend on whether presenting or pinhole acuity, and unilateral or bilateral impairment, is used. Methods: We analysed 12 RAAB surveys undertaken between 2018 and 2023 in India, Nepal, Pakistan, Kenya, Tanzania and Uganda. Three person-level measures were compared: presenting visual acuity (PVA) in at least one eye, PVA in the better-seeing eye, and pinhole acuity in the better-seeing eye. Estimates were adjusted for the two-stage cluster design and age-standardised to the WHO world standard population. Results: Of 48,185 participants examined (response rate 94.3%), vision impairment based on pinhole acuity in the better eye (9-19%) was substantially lower than on PVA in the better eye (18-37%) or in at least one eye (33-51%). Increasing age (adjusted odds ratio [AOR] per year 1.106; 95% confidence interval [CI] 1.103-1.109), female sex (AOR 1.13; CI 1.08-1.19) and South Asian survey location (AOR 3.04; CI 2.78-3.33) were independently associated with impairment. Age-standardisation widened the difference between survey locations (prevalence ratio 1.50 crude, 1.66 standardised). Conclusions: Substantial vision impairment persists in the surveyed districts of both regions. The large gap between presenting and pinhole acuity indicates a considerable addressable burden, and restricting estimates to bilateral impairment in the better-seeing eye omits a further substantial share of need. The higher prevalence in the South Asian locations most plausibly reflects survey site selection and uncorrected refractive error rather than a regional epidemiological difference.

Background: High-quality, longitudinal data from the Emergency Department (ED) are essential for understanding acute illness trajectories and for developing clinically deployable prediction models. However, most existing ED datasets are static, limited in modality or disconnected from long-term outcomes or biomaterials. Methods: We describe a two-year sample of Acutelines, a continuously operating ED-based data-biobank infrastructure at the University Medical Center Groningen. Acutelines is embedded in routine care and captures the full acute care trajectory and uses a stepped consent procedure. It integrates demographics, vital signs, laboratory results, diagnoses, treatments, waveforms, patient-reported outcomes, and prospectively collected biomaterials. Data are linked to in-hospital outcomes and post-discharge mortality. Results: The presented dataset comprises 29,314 ED visits from 18,850 adult patients. Clinical variables are available for nearly all visits, with additional data and questionnaires (n=4,963) and biomaterials (n=2,723) collected in predefined subgroups. Associations between early triage features (National Early Warning Score, vital signs, diagnostic categories) and outcomes, illustrate the clinical depth and longitudinal value of the infrastructure. Conclusion: Acutelines is a living, continuously expanding research infrastructure. Its combination of ED-first inclusion, multimodal data, linkage to long-term outcomes, and availability of biomaterials distinguishes it from existing datasets. Acutelines provides a robust foundation for hypothesis generation, translational research, and the development, validation, and benchmarking of data-driven clinical decision support tools and biomarker tests in acute medicine, while its ongoing expansion enables prospective studies and interventional research. Trial registration: Acutelines is registered at ClinicalTrials.gov under trial registration number NCT04615065.

Introduction No widely adopted guidelines exist for collecting and reporting donor-level metadata in tissue-based research, limiting interpretability, reproducibility, and potentially introducing bias. This study aimed to inform ethical and appropriate metadata practices. Methods Semi-structured interviews were conducted with 16 investigators from the Human BioMolecular Atlas Program. Thematic analysis using inductively derived codes identified metadata elements and perspectives on their collection and reporting. Results Participants identified 80 metadata variables across six domains: demographic, sociodemographic, medical history, personally identifying information, cause of death, and tissue/organ data. Most supported routine collection and reporting of demographics and medical history, whereas views on cause of death and sociodemographic data were mixed. Conclusion We recommend routinely collecting and reporting demographics and medical history, while restricting cause of death and sociodemographic variables to situations with explicit consent or justification. These findings provide initial evidence to inform ethical donor metadata guidelines, with further stakeholder engagement and consensus-building needed.

Introduction: Clinical deterioration in patients admitted to hospital wards is a major cause of preventable morbidity and mortality and is frequently preceded by abnormalities in vital signs that occur hours before serious adverse events occur. Early identification of patients at risk provides an opportunity for timely intervention before irreversible organ dysfunction develops. The objective of this trial is to evaluate whether implementing a wireless patient monitoring system reduces mortality and cardiopulmonary failure in patients admitted to hospital wards. Methods and analysis: The i-PROTECT trial is designed as a stepped-wedge cluster randomized controlled trial. Hospital wards (total of 28 wards, constituting clusters in this design) are randomized to have wireless monitoring for selected high-risk patients, 7 wards at a time, with every 7 wards constituting a sequence. In the first period, all wards will have no wireless monitoring. After a baseline period of 2 (+1 transition) months, the intervention is implemented in a randomly selected new sequence every 3-month period until the intervention is implemented in all sequences. The control group will receive usual care with standard intermittent monitoring and no wireless monitoring. The calculated sample size is 13160 patients. The primary endpoint is cardiopulmonary failure; a composite endpoint of 30-day in-hospital mortality, cardiac arrest, and need for vasopressor or intubation. The trial started on Feb 1, 2026, and is expected to complete patient follow-up by the end of May 2027. Ethics and dissemination: The trial was approved by the Institutional review board (IRB) of Ministry of National Guard Health Affairs (IRB/2623/23). The results will be presented at relevant national and international critical care conferences and published in international peer-reviewed journals.

Introduction Diabetes distress describes the psychological and emotional burden of living with diabetes and is associated with reduced self-management and adverse diabetes outcomes. Clinical guidelines recommend routine assessment and management of diabetes distress, but this is not always implemented. Therefore, there is a need to develop approaches to deliver emotional health support in routine clinical care more effectively. We describe here the protocol for a study to I) assess the feasibility of implementation of the D-stress Pathway, comprising Enhanced Usual Care (EUC) and an online, group-based, psychological diabetes distress reduction intervention called REDUCE, ii) evaluate the feasibility of the study protocol iii) detect an effect signal of diabetes distress score and Interstitial Glucose Time in Range and iv) refine initial programme theories of how both interventions (EUC and REDUCE) work, for whom, and under what circumstances. Methods This feasibility study includes a multicentre trial within a cohort design (TWICs) where sites have a staggered exposure to the interventions alongside a realist process evaluation. Four UK NHS diabetes services will recruit 80 adults with type 1 diabetes ([≥]1 year) using continuous glucose monitoring (CGM) ([≥]3 months). All participants will receive EUC and provide monthly data over 7 months on diabetes distress (measured by the Type 1 Diabetes Distress Assessment System (T1DDAS) and interstitial glucose measured by using continuous glucose monitoring. Participants with elevated diabetes distress, will be offered the six-week, group-based, online REDUCE intervention plus EUC, compared to EUC alone. Up to twenty participants with type 1 diabetes, ten family members/friends, sixteen healthcare professionals delivering EUC and five REDUCE facilitators will be interviewed to explore their experience of receiving training and delivering the D-stress Pathway. Up to 20 EUC consultations and REDUCE sessions will be observed. Analysis Feasibility will be assessed against pre-specified progression criteria and analysed descriptively using summary statistics. Primary outcomes include baseline level of diabetes distress, recruitment rate, intervention uptake, and data completeness, which will be analysed descriptively. Qualitative data will be analysed using framework analysis guided by realist programme theories developed for this study. Ethics Ethics approval has been granted by NHS Research Ethics Committee (REC) (Bromley REC: 25/LO/0469) and Health Research Authority obtained. All participants will provide informed consent. Trial registration no: Registered at ClinicalTrials.gov number NCT07193446 on 26/11/2025. Protocol and statistical analysis plan: The trial protocol and statistical analysis plan can be accessed at ClinicalTrials.gov.

Background Adverse childhood experiences are major determinants of mental disorders, health-risk behaviours and non-communicable diseases across the life course, but evidence from India remains limited. This study aims to estimate the prevalence and patterns of adverse childhood experiences among Indian adolescents, examine their associations with mental health and non-communicable disease risk factors, and evaluate a culturally adapted school-based intervention integrating trauma-informed care and social-emotional learning. Methods A sequential mixed-methods study will be conducted among approximately 1,632 adolescents in 16 public and private schools in Chandigarh and Mohali, India. Phase I is a cross-sectional survey of adverse childhood experiences, mental health, perceived stress, sleep, screen time and behavioural and biological risk factors for non-communicable diseases. Phase II comprises focus group discussions and key informant interviews with students, parents, teachers, counsellors and mental health professionals to inform intervention development. In Phase III, findings from both phases will guide development of the intervention using the ADDIE (Analysis, Design, Development, Implementation and Evaluation) instructional design framework. In Phase IV, adolescents reporting ACE exposure will participate in a school-based intervention delivered over 8-12 weeks by trained psychologists, comprising trauma-informed social-emotional learning sessions, individual counselling sessions for high-risk adolescents (at least six sessions), school-wide awareness activities and parental sensitization. Effectiveness will be evaluated using a quasi-experimental pre-post design. The primary outcome will be change in emotional and behavioural difficulties measured by the Strengths and Difficulties Questionnaire (SDQ). Secondary outcomes will include changes in depressive symptoms (Patient Health Questionnaire-9), perceived stress, sleep quality, school functioning, and behavioural risk factors for NCDs. Recruitment began in April 2026 and is ongoing; data collection is expected to be complete by June 2028, and no results have yet been generated.

Background: Systematic reviews of clinical prediction models increasingly include studies using artificial intelligence (AI) and machine learning (ML) methods alongside traditional multivariable regression approaches. A previously published Excel tool enabled standardised data extraction using the CHARMS checklist and risk of bias assessment using PROBAST. The recent publication of the PROBAST+AI framework, which distinguishes the assessment of model development quality from the assessment of model evaluation risk of bias and assesses applicability in both parts, necessitates an updated digital instrument applicable across prediction modelling methods. Methods: We updated an open-access Excel tool to incorporate the full PROBAST+AI framework. The updated template incorporates structural separation between assessment of model development quality and model evaluation risk of bias, with applicability assessed in both parts. It also incorporates updated signalling questions, including those addressing methodological issues particularly relevant to AI/ML, and automates the generation of summary tables and graphical displays. Results: The updated tool (CHARMS & PROBAST+AI Template) contains 11 worksheets and supports data extraction and appraisal for up to 30 prediction models. Dedicated, linked worksheets enable separate assessment of model development and model evaluation, with Domain 4 distinguishing among Apparent, Internal, and External evaluation settings. Key updates include dedicated assessments for predictor pre-processing, class imbalance handling and recalibration, data leakage prevention, and replication of the full model development pipeline within resampling procedures. Automated sheets dynamically format tables and summary charts covering PROBAST+AI parts. Conclusions: The CHARMS & PROBAST+AI Excel template provides a standardised, user-friendly, and rigorous digital framework for systematic reviewers appraising traditional statistical and AI-driven clinical prediction models.

Background Temperature instability during neonatal transport contributes to adverse outcomes in preterm and low birth weight infants. Hypothermia in this population is associated with increased risk of intraventricular haemorrhage (IVH), sepsis, and death. Current transport temperature management is reactive and manually controlled. The Heating On Transport WitH prEtErm and Low birth weight neonates using Servocontrol patient temperature management system (HOTWHEELS) trial aims to determine whether automated, servo-controlled thermoregulation provides superior thermal stability compared to standard care and reduces hypothermia-associated adverse outcomes. Methods This prospective, randomised, superiority trial is conducted by the Newborn Emergency Transport Service of Western Australia. Infants with a gestational age of less than or equal to 34 weeks and/or weight of 1500 g requiring transport are randomised to serve-controlled or standard thermal care. The primary outcome is the proportion of infants with a temperature between 36.5 and 37.5 degrees Celsius on arrival at the receiving neonatal unit. Secondary outcomes include the incidence of IVH in the first 7 days, mortality before discharge, the incidence of moderate (<36.0) and severe (<35.0) hypothermia for greater than 15 minutes and the temperature change during transport. Trial registration: ANZCTR12624000503527. Impact HOTWHEELS is the first randomised trial in neonatal transport to evaluate servo-controlled temperature control. We believe the findings will inform standards of temperature control during transport for preterm and low birth weight infants.

Objectives To investigate the association between time spent in NHS Type 1 emergency departments (EDs, consultant led 24 hour services with full resuscitation facilities) and risk of leaving employment and hospitalisation after leaving the department alive up to two years after attendance. Methods We conducted a retrospective cohort study using linked administrative data from the NHS Emergency Care Dataset, Hospital Episode Statistics, Census 2021, and mortality records. ED length of stay was categorised from under 2 hours to 12 hours or more. Cox proportional hazards models were fitted to estimate the association between ED length of stay and subsequently leaving employment or being hospitalised over a two year follow-up period, adjusting for demographic, socioeconomic, and clinical characteristics. Results Our study population comprised 3,347,008 individuals aged 25 to 64 who attended a Type 1 ED in England between April 2021 and March 2023. For leaving employment, adjusted hazard ratios (aHRs) increased from 1.04 (95% CI 1.03 to 1.06) for stays of 2 to <4 hours to 1.21 (1.17 to 1.24) for 12 hours or more, compared with stays under 2 hours. A similar but more pronounced gradient was observed for post-discharge hospitalisation, with aHRs rising from 1.06 (1.04 to 1.07) at 2 to <4 hours to 1.95 (1.91 to 1.99) for stays of 12 hours or more. Conclusions Prolonged time spent in the ED is associated with poorer outcomes among working-age employees, including reduced labour market participation and increased hospital use. These findings suggest that long ED stays may have wider and longer-term implications beyond immediate clinical outcomes, including potentially for national labour markets and economic growth.

Background Falls in hospitals are associated with injuries, deaths and poor patient outcomes. Although clinical guidelines recommend educating hospital patients about how to prevent falls, not all hospitals systematically deliver evidence-based patient falls education. The primary aim of this study is to implement and evaluate the effectiveness of delivering a research-informed education program called the Safe Recovery Program with ward support on rates of falls and falls-related injuries in hospitals. The secondary aims include measuring changes in patient and staff knowledge and awareness about falls prevention and identifying barriers and facilitators to staff and patients taking action to reduce hospital falls. Methods The trial will adhere to the Consolidated Standards of Reporting Trials guidelines. Twelve wards will be recruited from five Australian hospitals over a 65-week period. A stepped-wedge cluster randomised controlled trial design will be used with unidirectional crossover from control to experimental conditions together with randomisation of when each cluster makes the transition. The crossovers will occur at 12 timepoints, each five weeks apart. Alongside the trial, patients and staff on participating wards will be recruited for interviews and qualitative data analyses will be conducted to understand how to optimise implementation. The experimental condition involves usual care plus delivery of the Safe Recovery Program. For the Safe Recovery Program, supervised allied health assistants will deliver brief falls education programs to all suitable patients in designated wards, reinforced by all ward staff. Falls champions, who are registered nurses and allied health professionals, will provide Safe Recovery Program training for staff, using a train-the-trainer model. The ward staff will also be trained in how to support hospital patients to adopt safe behaviours. The primary outcome will be falls per 1000 patient bed days. The secondary outcomes will be: (i) injurious falls per 1000 patient bed days (ii) patient and staff changes in falls awareness, knowledge and motivation; and (iii) barriers and enablers to hospital staff engaging in behaviour change and program implementation. An economic evaluation will also be conducted to estimate the incremental cost effectiveness of implementing the Safe Recovery intervention. Ethics and Dissemination Ethics approvals have been obtained from The Royal Melbourne Hospital Human Research Ethics Committee (HREC/113864/MH-2024). The findings will be disseminated through peer-reviewed journals, workshops and conferences. Consumer team investigators will guide the communication of findings to the target audiences, including older patients, hospital staff, healthcare managers and policy makers. Trial Registration Number: ACTRN12624001469505

Background Traditional participant information and consent forms (PICFs) have changed little over time and are often lengthy and complex. A novel consent process incorporating plain language, an infographic brochure and a short explanatory video was developed to improve communication of clinical trial information. The SImPLE study was designed to evaluate whether this novel consent process improves comprehension of clinical trial information, participant engagement and the consent experience compared with a traditional PICF. Design and Setting SImPLE is a randomised two-period crossover study involving adults receiving cancer treatment who are potentially eligible for clinical trial participation. Study materials were developed for the ANZadapt (ANZUP2101) prostate cancer clinical trial; however, participants are not being recruited to ANZadapt itself. Participants are randomised to receive either a standard 17-page NHMRC-style PICF followed by a novel consent process, or the reverse sequence, with a washout period of at least 7 days between study periods. The novel consent process comprises a simplified 4-page PICF, infographic brochure and short explanatory video. Twenty-four hours following each PICF review, participants complete a comprehension assessment and structured interview. Outcomes and Endpoints The primary endpoint is comprehension of clinical trial information, measured using a study-specific 22-item questionnaire comprising 10 true/false and 12 multiple-choice questions. Secondary endpoints include acceptability, assessed through participant preference for communication format, and engagement, assessed through confidence in explaining the trial and likelihood of agreeing to participate. Planned Analyses The primary analysis will compare comprehension scores between the novel and standard consent approaches using a paired t-test among participants completing both study periods. Secondary outcomes relating to acceptability and engagement will be summarised descriptively and compared between consent approaches as appropriate. Sensitivity analyses will be performed to assess the robustness of the primary findings and the potential impact of crossover design effects.

Background Sepsis is a life-threatening medical condition caused by the bodys extreme response to an infection. It can have lasting physical, cognitive, psychological and social consequences that extend beyond the acute illness. However, limited research has explored how people with a history of sepsis and their families experience these longer-term consequences and engage with healthcare services in Ireland. Methods A qualitative study was conducted using semi-structured interviews with 21 participants, including 14 people who had personally experienced sepsis and seven family members of people affected by sepsis. Participants were recruited through professional networks and a sepsis charity organisation in Ireland. Interviews were conducted by telephone or Zoom between May and June 2026, audio-recorded and transcribed verbatim. Data were analysed using Braun and Clarke's reflexive thematic analysis. Results Five themes were identified: (1) recovery - a prolonged journey of physical & cognitive rebuilding; (2) navigating a recovery journey: lack co-ordination and integration; (3) continuity of support was uneven and often depended on individual healthcare professionals; (4) recovery reshaped family roles, work and everyday life; and (5) participants suggested a more coordinated approach to recovery. Participants described persistent physical, cognitive and psychological difficulties, alongside substantial effects on family responsibilities, employment and everyday activities. While some participants experienced valuable support from individual healthcare professionals, many described fragmented services, limited information about recovery and uncertainty about where to seek ongoing support. Conclusion Individuals with a history of sepsis and their families described substantial and ongoing consequences and variable experiences of longer-term care. The findings highlight the need to better recognise and respond to longer-term health needs following sepsis and to develop coordinated, accessible approaches to ongoing support in Ireland.