Allergic rhinoconjunctivitis (ARC) is a highly prevalent immune-mediated condition associated with substantial symptom burden, impaired quality of life and increased healthcare use. Emerging evidence highlights the role of the gut microbiome in immune regulation and allergic disease. Fermented foods may contain live microbes (when unpasteurised or uncooked) and bioactive postbiotic metabolites that can modulate immune responses. Despite growing interest in dietary strategies targeting the microbiome, no randomised controlled trial has compared fermented versus unfermented red cabbage for ARC.

This single-centre, randomised, controlled trial with a sensory-matched, unfermented cabbage comparator investigates the effects of daily consumption of fermented red cabbage for 8 weeks compared with an unfermented red cabbage control in young adults (18–35 years) with ARC. A total of 158 participants will be randomly assigned (1:1). The primary outcome is change in Total Nose and Eye Symptom Score from baseline to week 8. Secondary outcomes include daily symptoms and medication use captured via mobile ecological momentary assessments, quality of life, psychological well-being, gastrointestinal symptoms, systemic inflammatory markers, total IgE, immune cell profile and metagenomic characterisation of stool samples. A nested qualitative component explores participants’ experiences and acceptability of the intervention. Analyses will include mixed-effects models, time-series analyses incorporating daily pollen counts and comprehensive microbiome statistics. Safety outcomes and adverse events will also be assessed.

This study was approved by the Ethics Committee of Charité—Universitätsmedizin Berlin (EA4/043/25) and is conducted in accordance with the Declaration of Helsinki and Good Clinical Practice. Results will be disseminated through peer-reviewed publications, conference presentations and a lay summary provided to participants. Anonymised datasets and analysis scripts will be made available in public repositories, and metagenomic sequencing data will be deposited in an international sequence archive to ensure transparency and reproducibility.

DRKS00036475.

This study aimed to quantify how patient risk factors relate to COVID-19 severity across categories 1–5 in a prospective, hospital-based cohort. We hypothesised that greater severity would be associated with higher odds of intensive care unit (ICU) admission and in-hospital mortality. Secondary aims were to assess associations with age, viral variants, symptom clusters, lymphocyte count, fasting blood glucose and cytokine profiles.

Prospective cohort study.

A secondary-care/tertiary-care hospital and linked community settings in Cheras, Kuala Lumpur, Malaysia.

This study was nested within the COVGEN project, a prospective COVID-19 cohort conducted at Hospital Canselor Tuanku Muhriz UKM (HCTM), Cheras Health Clinic and the Bandar Tun Razak COVID-19 Assessment Centre in Cheras, Kuala Lumpur, Malaysia, from 1 August 2021 to 31 October 2022. 2532 participants were enrolled at baseline. Eligible participants were Malaysian citizens aged 12–18 years (paediatric/adolescent) or ≥18 years who had reverse transcription-polymerase chain reaction–confirmed COVID-19 at recruitment and resided in Kuala Lumpur or Selangor. Patients who had a clinically unstable condition and those who declined participation (personally or via a next-of-kin or legal representative) were excluded. This analysis included 559 patients hospitalised at HCTM; after excluding five with incomplete questionnaires, 554 remained for analysis (413 admitted to general wards and 141 to ICUs). Categories 3–5 comprised hospitalised patients, whereas categories 1–2 included hospitalised individuals and a subset recruited from community settings.

Primary outcomes included disease severity (categories 4–5 vs 1–3), ICU admission and in-hospital mortality. Secondary outcomes included associations with age strata, viral variant (delta vs omicron), symptom clusters, lymphocyte count, fasting blood glucose and cytokines: interferon gamma-inducible protein 10, interferon gamma, interleukins 8, 10, 2, 6 and 7 and tumour necrosis factor alpha.

141 of 554 (25.5%) patients required ICU care. Compared with milder categories, category 5 was associated with markedly higher odds of ICU admission (OR 204.50; 95% CI 37.54 to 1114.18; p55 versus

An increasing clinical severity category was strongly associated with ICU admission and mortality. Age, delta infection, specific symptom clusters, lymphopenia, hyperglycaemia and pro-inflammatory cytokines identified higher-risk patients, supporting risk-stratified management and prioritisation for enhanced monitoring.

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

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

Adult emergency departments of comprehensive specialised hospitals in northwest Ethiopia.

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

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

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

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

To assess health-related quality of life (HRQoL), treatment satisfaction and associated factors among older adults with acute heart failure in Northwest Ethiopia.

Prospective, multicentre observational study.

Three tertiary hospitals in Northwest Ethiopia provide secondary and tertiary care services.

A total of 422 patients aged ≥60 years with a confirmed diagnosis of acute heart failure were consecutively enrolled between December 2024 and April 2025. Patients with unstable psychiatric conditions or advanced kidney disease were excluded.

HRQoL was assessed using the WHO Quality of Life – Brief Version questionnaire, and treatment satisfaction was measured using the Treatment Satisfaction Questionnaire for Medication (TSQM). Multiple linear regression identified factors associated with HRQoL and treatment satisfaction.

95% of participants reported moderate HRQoL, and 3% reported poor HRQoL. Weight loss was positively associated with HRQoL (β=1.52; 95% CI 0.04 to 3.07; p=0.021), whereas asthma was negatively associated with HRQoL (β = –3.28; 95% CI 6.94 to 0.37; p=0.001). Regarding treatment satisfaction, 65% of patients were moderately satisfied, with notable concerns regarding medication safety and overall experience. Rural residents reported lower satisfaction than urban residents (β = –0.20; 95% CI 0.34 to 0.05; p=0.007). Patients with New York Heart Association (NYHA) class III had higher satisfaction (β=0.25; 95% CI 0.05 to 0.45; p=0.016). Effective hypertension management was linked to increased satisfaction (β=0.20; 95% CI 0.02 to 0.37; p=0.026), whereas coronary heart disease was associated with lower satisfaction (β = –0.40; 95% CI 0.64 to 0.88; p=0.012).

Among older adults with heart failure in Northwest Ethiopia, 98% reported moderate to low HRQoL. Asthma and polypharmacy negatively affected HRQoL, whereas weight loss was positively associated with HRQoL. An NYHA class III status and well-managed hypertension improved treatment satisfaction, whereas rural residency and coronary heart disease were associated with lower satisfaction. These findings underscore the need for targeted interventions to enhance outcomes and QoL in this vulnerable population.

Providing peer support can benefit youth peer support workers (peers)et by supporting self-determination, recovery and resilience to self-stigma. There is a need to clarify the role of the organisation in providing benefits for peers. We aimed to identify the organisational contexts and mechanisms that result in the creation of healthy workplaces for peers.

Rapid realist review guided by the Realist and Meta-Narrative Evidence Syntheses–Evolving Standards guidelines and Pawson’s iterative approach.

MEDLINE, CINAHL, PsycINFO, ERIC, SocINDEX, Google Scholar and Embase were searched from 1979 to 2025.

We included qualitative and quantitative peer-reviewed studies and grey literature that captured characteristics of organisational practices and employment considerations in youth peer support programmes.

Articles were screened independently by multiple reviewers. Inclusion criteria were adjusted to capture literature on organisational practices, and employment considerations for youth peer support programmes. Data were extracted and analysed retroductively to develop Context-Mechanism-Outcome Configurations (CMOCs).

Five employment-related risks to peer well-being were identified: (1) difficulty entering the job market, (2) lack of role clarity, (3) pressure to live up to ideals, (4) retraumatisation and (5) stigma. Six CMOCs were developed; all focused on the creation of equitable employment and supporting peer development and empowerment were developed.

Community-based mental health organisations can facilitate equitable peer employment through strategies that reduce professional stigma, enhance peer resilience and promote professional and personal development. Policy reform that addresses precarious work conditions is needed to support healthy work environments.

Glucocorticoid therapy is prescribed for a variety of inflammatory conditions and is associated with severe adverse effects. A glucocorticoid withdrawal syndrome (GWS) may occur after prolonged glucocorticoid treatment—with or without biochemical glucocorticoid-induced adrenal insufficiency (GIAI). Previously, GWS was not considered an entity, probably due to the overlap between symptoms of GWS and GIAI. The Addison’s disease-specific quality of life questionnaire (AddiQoL-30) is a validated tool for quantifying symptoms of adrenal insufficiency resembling GWS. In the present study, we test the hypothesis that patients with a low AddiQoL-30 score and/or low cortisol response to a short Synacthen test (SST), after cessation of prednisolone treatment, may benefit from low-dose hydrocortisone therapy without increasing the risk of metabolic and cardiovascular disease during prolonged cortisol exposure.

REPLACE is a multi-centre, double-blinded, placebo-controlled randomised controlled trial in patients with polymyalgia rheumatica or giant cell arteritis after cessation of prednisolone treatment. Criteria for randomisation are an AddiQoL-30 score ≤85 and/or plasma cortisol response to SST, 30-min p-cortisol >100 and 85; and (2) patients with a SST-stimulated cortisol ≤100 nmol/L.

The study is conducted in accordance with the Declaration of Helsinki, registered at the Clinical Trials Information System (CTIS: 2024-513822-53-00) and Clinicaltrials.gov (NCT05193396), and publications will be in accordance with the recommendations of the International Committee of Medical Journal Editors. The trial is monitored by local independent Good Clinical Practice units and overseen by the Danish Data Protection Agency (journal no. 21/27119), the Regional Committees on Health Research Ethics for Southern Denmark (project ID: S-20210076), the Danish Patient Safety Authority and the Danish Medicines Agency.

NCT05193396.

The Happy Healthy Active Children (HHAC) initiative is a multicomponent community-based initiative aimed at promoting physical activity, food literacy and nature literacy among children in early childhood kindergarten and primary school settings. Developed in collaboration between Activity Experts and Community Stakeholders, HHAC integrates thematic activities (Play, Nature, Food) across kindergartens, schools and the broader community. The initiative responds to growing concerns about declining physical activity levels, insufficient contact with nature and poor dietary habits in childhood, factors known to influence long-term health and well-being. This protocol outlines the design, implementation and planned evaluation of the HHAC initiative.

HHAC is carried out within the long-term strategic initiative Tingbjerg Changing Diabetes. Following the Supersetting approach, HHAC addresses inequity in health by mobilising resources across local settings (kindergartens, schools and the local community arenas) and population groups (children, parents, staff and other community members) to develop and implement contextually relevant activities promoting outdoor play, cooking and nature experiences. Activities are evaluated using a within-subject design in kindergartens, while in schools a quasi-experimental design with matched control groups is applied. Data is collected at baseline and follow-up through accelerometry, validated questionnaires and structured observations. Primary outcomes include physical activity levels, food literacy and nature literacy. Analyses apply linear mixed-effects models to account for repeated measures and clustering at the institutional level. The evaluation also investigates implementation processes and context-mechanism configurations through a comprehensive realist evaluation. This includes developing a programme theory, conducting interviews with children, parents, staff and other local stakeholders and participant observations aiming to explore experiences and the mechanisms through which the activities contribute to changes in behaviour and well-being. All data will be analysed and condensed for a model for transferability.

Findings will be disseminated through peer-reviewed journals, conference presentations and public engagement activities targeting educators, policymakers and health professionals. The intervention materials will also be made freely available to support broader implementation. The study procedures were registered and approved by The Capital Region’s centre for data reviews ‘Videnscenter for Dataanmeldelser’ (Reference: P-2023–14277). All procedures were carried out under relevant regulations and guidelines. Written information about the study was given to all school principals, teachers and parents/guardians before the start of the study, and written informed consent is obtained from all legal guardians of all participants in their native language prior to child enrolment.

To test the agreement and usability of a novel quality appraisal tool: A MeaSurement Tool to Assess systematic Reviews of Prognostic Factor studies (AMSTAR-PF).

Observational study.

14 appraisers of varied experience levels and backgrounds, including undergraduate, master’s and PhD students, postgraduate researchers, research fellows and clinicians.

Eight systematic reviews were rated by all reviewers using AMSTAR-PF.

Planned measures included intrapair and inter-pair agreement using Cohen’s and Fleiss’ kappa, time of use and time to reach consensus. Interrater agreement was an added measure, and Gwet’s agreement coefficient was calculated and presented due to its greater stability across agreement levels. The percentage of intrapair agreements identical or one category apart was also presented.

Interrater agreement averaged 0.59 (range 0.21–0.90), inter-pair agreement 0.61 (range 0.24–0.91) and intrapair agreement 0.75 (range 0.45–0.95) across the domains, with agreement for the overall rating 0.46 (95% CI 0.30 to 0.62) for interrater agreement, 0.46 (95% CI 0.17 to 0.74) for inter-pair agreement and 0.68 (range of averages 0.22–1.00) for intrapair agreement. The majority (60.7%) of intrapair ratings were identical, with 94.6% of final ratings either identical or only one category different for the overall appraisal. The time taken to appraise a study with AMSTAR-PF improved with use and averaged around 34 min after the first two appraisals.

Despite some variance in agreement for different domains and between different appraisers, the testing results suggest that AMSTAR-PF has clear utility for appraising the quality of systematic reviews of prognostic factor studies.

Respiratory infections like influenza and SARS-CoV-2 pose significant global health risks due to their high transmissibility and severity. SARS-CoV-2 has caused over 7 million deaths worldwide, and the Lancet Commission estimates a >20% chance of a similar respiratory virus pandemic within a decade. Schools, often poorly ventilated, are high-risk settings for transmission. While COVID-19 school closures may have reduced transmission, they likely caused learning loss, mental health issues and increased burdens on parents and caregivers. Air purifiers with High Efficiency Particulate Air (HEPA) filters may offer a non-disruptive mitigation strategy, but the evidence to support their effectiveness in reducing viral transmission is weak. This protocol describes a cluster-randomised, parallel, two-arm, group sequential superiority trial with an interim analysis—to allow early stopping for efficacy or futility—to estimate the effect of portable air purifiers with HEPA filters in primary school classrooms on student absenteeism.

This group sequential trial will randomise schools (clusters) 1:1 to intervention or control arms in two stages: winter 2025/2026 (N=32 schools; ~736 students) and winter 2026/2027 (N=30 schools; ~690 students). The study setting is Norway. Eligible schools must have classrooms suitable for portable air purifiers, >10 students in grades 5–7 (typically aged 10–13 years) and principal consent. Intervention and control classrooms will each receive two portable air purifiers with HEPA filters operating at a performance equivalent to 3.0 and 0.3 air changes per hour, respectively, with control purifiers acting as shams. Outcomes will be measured during and at the end of a 12-week period. The primary outcome is student absenteeism, measured as full child days of absence aggregated at the class level. An interim analysis is planned at the end of the first stage, with error-spending O’Brien-Fleming stopping boundaries that are binding for efficacy and non-binding for futility. The primary estimand is the marginal incidence rate ratio of student absences, estimated using generalised estimating equations with a negative binomial model to account for overdispersion. Prespecified stopping boundaries will determine stopping, with efficacy boundaries being binding. Treatment effects will be estimated using cluster-bootstrapped CIs adjusted to provide strong control on overall type I and II error probabilities, and a bias correction will be applied if the trial is stopped early for efficacy. All analyses will follow the intention-to-treat principle. The primary question is whether installing and operating air purifiers with HEPA filters (intervention) reduces student absenteeism due to sickness (primary outcome) compared with sham air purifiers (control). Secondary questions examine whether the intervention reduces teacher absenteeism due to respiratory infections, rate and 12-week risk of self-reported respiratory infections among teachers, and teachers’ perceptions of air quality, compared with sham air purifiers. If the trial estimates a statistically significant effect for the primary outcome, a cost-consequence analysis will evaluate the direct and indirect costs associated with operating air purifiers against the potential benefits of reduced student and teacher absenteeism. A process evaluation will explore mechanisms of effect.

The trial has been approved by the Regional Committees for Medical and Health Research Ethics and the National Research Ethics Committee (ref. 737650). Absence data, routinely collected and fully anonymised at the class level, will serve as the primary outcome and does not require informed consent. Informed consent will be obtained from teachers participating in weekly surveys or interviews. Results will be disseminated to stakeholders, participants and the public through peer-reviewed journals, scientific meetings and social media.

NCT07119333.

Stillbirth remains a major global health challenge, with India bearing a substantial share of the burden. Despite the availability of evidence-based interventions, stillbirth rates (SBRs) remain high due to gaps in healthcare access, quality and the effective delivery of maternal and neonatal care. This study aims to develop and implement an optimised, context-specific model to reduce SBRs in Sangrur district, Punjab.

This mixed-methods implementation research will adopt a sequential explanatory design. The study will be conducted over 3 years in four blocks of Sangrur. Data will be collected through baseline and endline surveys, verbal autopsies of stillbirths, direct observations of antenatal and intrapartum care, and qualitative interviews with community members and healthcare providers. The intervention package will focus on preconception and antepartum care, intrapartum care and strengthening health systems. The study will use the plan-do-check-act model for continuous improvement, and real-time data collection through electronic systems will support timely decision-making.

The study expects to achieve a 25% reduction in SBRs through the optimised delivery of high-quality antenatal and intrapartum care services. Additionally, the research will provide critical evidence on the barriers and facilitators to optimise service delivery, as well as insights into the health system and community factors influencing stillbirth outcomes. This study aims to create a scalable and adaptable intervention model to reduce SBRs in low-resource settings like Sangrur and Punjab. The findings will inform future maternal and neonatal health policies and provide a framework for the broader implementation of similar interventions in other regions of India.

The study protocol has been approved by the International Institute of Health Management Research, Delhi (IIHMR) Institutional Ethics Committee (IRB/2024-2025/01). The study is funded through a competitive call for proposals on stillbirths by the Indian Council of Medical Research (ICMR) under the National Health Research Priority Projects (5/7BMIPR/2022-RBMCH). The research has been awarded by ICMR (project ID NHRP05586) to IIHMR under grant number 5/7/BMIPR/2022-RCN.

Hysterectomy, a common surgical procedure, is frequently associated with moderate-to-severe postoperative pain and a high incidence of postoperative nausea and vomiting (PONV). Dexamethasone, a corticosteroid, may help alleviate these symptoms; however, existing evidence is largely drawn from mixed surgical populations and does not specifically address its efficacy and safety in hysterectomy patients. This meta-analysis provides a focused and updated synthesis of randomised controlled trials (RCTs) in this population, incorporating time-stratified pain outcomes and subgroup analyses by dose, surgical approach, timing and route of administration to evaluate the role of dexamethasone in postoperative recovery.

Systematic review and meta-analysis using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.

PubMed, Scopus, Google Scholar and The Cochrane Central Register of Controlled Trials (CENTRAL) were searched through 1 November 2024.

We included RCTs comparing dexamethasone with placebo for postoperative outcomes in hysterectomy patients.

Two independent reviewers used standardised methods to search, screen and code included studies. Risk of bias was assessed using the Cochrane Collaboration and Evidence Project tools. Meta-analysis was conducted using random effects models. Findings were summarised in GRADE evidence profiles and synthesised qualitatively.

15 RCTs (1362 patients) were included. Dexamethasone significantly reduced PONV (risk ratio (RR): 0.53, 95% CI 0.47 to 0.61, p2: 0% high certainty) and pain scores at 24 hours (mean difference (MD): –0.20, 95% CI –0.35 to –0.05, p=0.009, I²=0%, moderate certainty), 8–12 hours (MD: –0.60, 95% CI –0.88 to –0.31, p2: 27%, moderate certainty and 4 hours (MD: –0.43, 95% CI –1.07 to 0.21, p=0.19, 93%, moderate certainty). It also decreased the use of rescue antiemetics (RR: 0.57, 95% CI 0.43 to 0.75, I²: 39%, high certainty) and postoperative opioid consumption (standardised MD: –0.48, 95% CI –0.90 to –0.05, p=0.03, I²: 74%, low certainty). The effects of rescue analgesics and hospital stay duration were nonsignificant. Subgroup analyses showed consistent antiemetic efficacy of dexamethasone across doses, timings, routes and procedures. For pain, greater analgesic effects were seen with higher doses and perineural administration, particularly at 8–12 hours. The risk of bias was low in most studies, but evidence of publication bias was observed for the pain score outcome.

Dexamethasone is an effective adjunct in hysterectomy, significantly reducing PONV and postoperative pain at 8–12 and 24 hours, particularly with 4–10 mg doses. Benefits are consistent across routes, timings and surgical approaches, with greater early analgesia after perineural use. It reduces opioid consumption but has a limited effect on rescue analgesia, supporting its role as a complementary analgesic. While generally considered safe, current safety data are limited, highlighting the need for further research. These results support its use in multimodal recovery protocols and identify priorities for future studies in high-risk and diverse surgical populations.

CRD42024608067.

Ensuring gender equity in leadership is crucial for fair representation and diversity in academic medicine. This study aims to investigate the representation of women in leadership positions in Turkish academic medicine, including medical schools, specialty boards, conferences and medical journals.

A cross-sectional study was conducted between August and December 2023. The study analysed data from members of medical faculties, specialty boards, medical conferences and medical journals across Turkey. The source of information was publicly accessible websites.

The study included data from 17 939 members of 113 medical faculties, 112 specialty boards, 73 medical conferences and 246 medical journals in Turkey.

This study has no interventions.

Women made up 40.4% of all medical-school faculty but only 22.5% of deans (95% CI 15.5 to 31.6; p

Turkey’s academic medicine pipeline contains substantial numbers of women, yet marked gaps persist in senior positions. Bridging these gaps will require targeted policies that look beyond overall workforce proportions to the specific decision-making roles where shortfalls remain.

HIV pre-exposure prophylaxis (PrEP) is an effective HIV prevention tool, reducing infection risk by up to 99% when used as prescribed. Despite its proven efficacy, PrEP uptake remains suboptimal, particularly among high-risk populations in Canada. Barriers to access and uptake, including stigma, financial constraints and healthcare accessibility, persist, highlighting the need for targeted interventions. The objective of this scoping review is to identify and map the extent and types of interventions, programmes, practices and policies aimed at increasing the acceptance, access, uptake and sustained use of HIV PrEP in Canada.

This review will use the Joanna Briggs Institute (JBI) Scoping Review methodology. Databases to be searched are MEDLINE, Embase, PsycINFO, Cochrane Library, CINAHL, Scopus and Web of Science from 2016 onwards. Two independent reviewers will screen studies, based on the inclusion criteria. The search results will be presented in a Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram. Data will be extracted from relevant studies by two independent reviewers and summarised to inform future research and policy development. This review will include studies focusing on individuals in Canada who are eligible for or using PrEP for HIV prevention. The interventions considered will address the awareness, acceptance, access, uptake and sustained use of PrEP. Studies must be set within the Canadian context, considering geographic, cultural and systemic factors. Exclusions include studies conducted outside Canada or those not addressing HIV prevention interventions.

This research will rely exclusively on previously published data and will not include human participants. Therefore, ethics approval is not required. For further clarification, please contact Stephen Hwang, Director, MAP Centre for Urban Health Solutions, Unity Health Toronto, at Stephen.Hwang@unityhealth.to. The findings of this research will be shared through peer-reviewed journal articles, conference presentations and may be relevant to governmental health agencies and local HIV/AIDS service organisations.

The protocol has been registered with Open Science Framework at https://doi.org/10.17605/OSF.IO/C7S4Z.

The use of digitally enabled technology is considered a promising platform to prevent morbidity and enhance youth mental health as youth are growing up in the digital world and accessing the Internet at increasingly younger age. This scoping review will identify, describe and categorise the models, frameworks and strategies that have been used to study the implementation of digital mental health interventions targeted at youth aged 15–34 years.

We will conduct a scoping review following the Arksey-O’Malley five-stage scoping review method and the Scoping Review Methods Manual by the Joanna Briggs Institute. Implementation methods will be operationalised according to pre-established aims: (1) process models that describe or guide the implementation process; (2) evaluation frameworks evaluating or measuring the success of implementation; and (3) implementation strategies used in isolation or combination in implementation research and practice. Primary research studies in all languages will be identified in CINAHL, Cochrane Central Register of Controlled Trials, Embase, ERIC, Education Research Complete, MEDLINE and APA PsycINFO on 6 January 2025. Two reviewers will calibrate screening criteria and the data charting form and will independently screen records and abstract data. We will use the Evidence Standards Framework for Digital Health Technologies by the National Institute for Health and Care Excellence to classify digital interventions based on functions, and a pre-established working taxonomy to synthesise conceptually distinct implementation outcomes. Convergent integrated data synthesis will be performed.

Ethical approval is not applicable as this scoping review will be conducted only on data presented in the published literature. Findings will be published and directly infused into our multidisciplinary team of academic researchers, youth partners, health professionals and knowledge users (healthcare and non-governmental organisation decision makers) to co-design and pilot test a digital psychoeducational health intervention to engage, educate and empower youth to be informed stewards of their mental health.

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

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

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

NCT06581965.

Health emergencies continue to stimulate greater interest in health systems and services, particularly their ability to respond to such shock. While studies have been done on health system response to health emergencies, there has been no attempt to synthesise this body of evidence to inform future emergency preparedness and response plan, particularly in low- and middle-income countries (LMICs) where health systems are deemed to be weak. This paper aims to provide a systematic review protocol for synthesising evidence on health system response to health emergencies in LMICs.

The WHO building blocks of health system functioning will be used as a conceptual framework for the review. The review will be conducted and reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Nine electronic databases will be searched: Medline, Embase, Ovid Emcare, Scopus, ScienceDirect, Academic Search Complete, HINARI, CINAHL and African Index Medicus. The search will be supplemented by citation searching, searching reference lists of included articles, search for grey literature in Google Scholar and relevant websites. Studies focusing on health system response to health emergencies in LMICs, published in English and between 2007 and 2025, will be eligible for inclusion. A narrative synthesis will be performed on all the included studies. Studies will be mapped and categorised into the WHO six building blocks of health system functioning, exploring relationships between and within studies, identifying the response mechanisms of the health system during health emergencies and their barriers and facilitators.

The data to be used do not include individual patient data, so ethical approval is not required. The results of the systematic review will be disseminated through a peer-reviewed journal publication, presentations at conferences and seminars.

CRD42024556271

Identifying anxiety disorders in autistic youth can be challenging due to the unique presentation of anxiety symptoms in autistic youth and the difficulties youth may have reporting on their own anxiety symptoms. These challenges underscore the need for objective and reliable measures. Understanding whether autonomic activity is associated with the presence of anxiety may lead to its use as an objective anxiety assessment tool in individuals who may otherwise struggle to communicate their feelings of anxiety. Most published studies examining autonomic activity and anxiety in autistic individuals lack information regarding racial demographic information, and those that do are predominantly composed of White individuals. These findings highlight the critical need for future research that includes more diverse samples and uses consistent, ecologically valid methods to examine the relation between anxiety and autonomic activity in autistic populations. This study aims to recruit a large sample of racially diverse adolescents to evaluate whether atypical autonomic activity serves as a biomarker of anxiety in autistic and non-autistic youth. This manuscript outlines the recruitment strategies for this study protocol, providing a framework for understanding the interplay between physiological, psychological and contextual factors including self-identified race in anxiety among autistic and non-autistic adolescents.

Autistic (n=80) and non-autistic (n=80) adolescents aged 11–14 years and their caregivers will be invited to participate in the current study. Autism diagnosis will be confirmed by gold-standard assessments. All participants will complete an in-person visit assessing their child’s cognitive abilities and trait-level anxiety and mental health symptoms, learn how to wear a non-invasive heart rate band that will collect ECG and respiration data, complete a 5-minute in-lab baseline of autonomic activity and enroll in experience sampling. Next, participants will complete three 5-minute baselines of autonomic activity at home, followed by 5 days of wearing the heart rate band for 5 hours per day, overlapping with ecological momentary assessment of their mood. Primary outcome measures include trait-level parent and self-reports of anxiety, real-time self-reports of anxiety captured through ecological momentary assessment, and both baseline and in-the-moment heart rate variability.

The study protocol has been approved by the University of Maryland’s Institutional Review Board. Results will be disseminated through peer-reviewed publications and conferences. Deidentified data from participants who consent to have their data shared with other researchers will be uploaded to the National Data Archive Collection C5316.

Health coaching is the process of working with a trained coach, peer, or healthcare professional towards self-determined health and wellness goals. Health coaching is being increasingly adopted in multiple healthcare settings and has been shown to improve overall health outcomes and long-term maintenance of chronic conditions in multiple countries and healthcare settings. Research surrounding the costs of implementing health coaching and its effects on healthcare costs, particularly long-term costs, has been limited. Although analysis of healthcare costs has become an important priority in recent years, the available literature looking at the cost impacts of health coaching is small and inconclusive, finding mixed results with a variety of methodologies. This scoping review aims to identify gaps in the literature and help set a research agenda regarding the costs of health coaching implementation and its impacts.

The scoping review will be structured according to Levac et al’s enhancement to Arksey and O’Malley’s framework for conducting scoping reviews. PubMed, Embase, and the Health and Medicine Collection will be searched for peer-reviewed research that includes health and wellness coaching and some measurement of cost. Details about the type of study, cost analysis, methodology and results from the included articles will be extracted and summarised. Full-text publications, excluding editorials and opinion pieces, included in this scoping review will be published in 2017 or later, will be written in English, will align with the definition of health coaching as described by the National Board for Health and Wellness Coaching, and will include cost measurement. This review will include publications not captured in the previous integrative literature review looking at the cost-effectiveness of health coaching.

Findings will be disseminated through a peer-reviewed publication and through presentations to both health system and community-based entities currently using or considering adopting health coaching. Ethics approval is not a requirement for this review as no human research participants will be involved. All data will be obtained from publicly available literature, with no primary data generated.

There is high interest in long-acting injectable antiretroviral therapy (LAI-ART) among people with HIV (PWH), with many conveniences for uptake and persistence. However, both patients and clinicians have expressed important barriers to effective implementation, including concerns about frequent clinic visits and strain on clinic resources. Administration of LAI-ART by a trained layperson injector (such as family, friend or partner of the patient) can help mitigate some of these patient-identified and clinician-identified barriers. Alternative LAI-ART delivery methods have the potential to increase the PWH and layperson injector’s confidence, empowerment, convenience, privacy and self-management skills and ultimately facilitate LAI-ART uptake and persistence.

INVITE-Home (innovative administration of long-acting injectables for HIV treatment enhancement at home) will support the expansion of LAI-ART in non-clinical settings by developing, implementing and evaluating a comprehensive, theory-informed training to support the administration of LAI-ART by a trained layperson injector. First, INVITE-Home will design and develop an innovative, theory-based layperson injector training to improve acceptability and uptake of LAI-ART in home-based settings, grounded in qualitative evaluation of training barriers and needs of PWH, layperson injectors and clinicians to develop the training. In Aim 2, INVITE-Home will enhance understanding of home-based LAI-ART using the training, by examining implementation and effectiveness of home-based LAI-ART injections.

This study and its protocols have been approved by the University of California, San Francisco (UCSF) Institutional Review Board and the scientific staff of HIV Research Branch, Division of HIV Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, at the Centers for Disease Control and Prevention. Study staff will disseminate findings locally (eg, to partnering clinics, via the UCSF Center for AIDS Prevention Studies’ Community Engagement Core), statewide (eg, the California Department of Public Health’s Office of AIDS) and nationally at conferences related to HIV.

NCT06488846.

An increasing number of teenagers and young adults (TYA) with chronic conditions and complex needs are transitioning from paediatric to adult services, including admission to intensive care units (ICUs). As these services are often ill-equipped to care for TYA, there is a risk of compromised care. Despite recent guidelines from the UK Paediatric Critical Care and Intensive Care Societies highlighting the importance and urgency of improving ICU transition, current recommendations are not evidence-based and established pathways for ICU transition remain limited.

This mixed-methods research study aims to generate evidence to underpin national policy on transition from paediatric to adult ICUs that will improve clinical care and patient experience. To do this, we will: (1) link and analyse UK national data (years 2017–2024) on paediatric and adult ICU admissions, hospital inpatient, outpatient and emergency care visits and survival status, to determine the clinical characteristics and healthcare resource utilisation from teenage years to early adulthood of people admitted to an ICU as a young person (admission aged 14 and 15), and how these relate to ICU admissions after age 16; (2) conduct semistructured interviews, online forums and surveys with TYA patients, carers and health professionals to understand their experience of transition in ICU services; and (3) synthesise these strands of evidence and use a structured process of stakeholder engagement to propose potential targeted improvements as appropriate.

This study was approved by the East of England - Cambridge South Research Ethics Committee on 1 August 2024 (research ethics committee number 24/EE/0108), and the Health Research Authority Confidentiality Advisory Group (CAG) on 7 October 2024 (CAG number 24/CAG/0068). Study results will be actively disseminated through peer-reviewed journals, conference presentations and accessible lay texts and graphic summaries for the use of charities and patients including those with learning disabilities and neurodevelopmental disorders.