Point-of-care technologies (POCTs) are essential to providing clinical care for patients, with their potential for rapid and accurate results on site supporting efficient clinical decision-making.

To understand the current key needs, barriers and challenges of POCT developers for effective development and implementation of POCTs across diverse settings particularly in the domain of cancer, nutrition and infections.

A qualitative semi-structured focus group discussion (FGDs) was employed. The FGDs were guided by the needs assessment process and the Phase Gate Framework. The qualitative data were coded and analysed in NVivo and refined into various themes.

The study was conducted in person at Cornell Tech Campus in May 2024, New York, USA.

24 participants were purposively sampled from the PORTENT (Point-of-Care Technologies for Nutrition, Infection and Cancer) network. Participants included technical developers (eg, engineers, scientists, startup leads) and expert stakeholders (eg, funders, policy advisors, clinicians and academic partners) involved in POCT development, evaluation and implementation.

A total of 24 participants participated in the in-person FGDs in New York (n=24). Key themes identified included gaps in stakeholder engagement, limited regulatory preparedness, insufficient market analysis, challenges in scaling and manufacturing and the need for context-specific adaptation in low- and middle-income country (LMIC) settings. Participants emphasised the importance of user-centred and context-responsive design, strategic partnerships and early planning for regulatory and implementation pathways.

Technical developers and expert stakeholders in the POCT landscape face various barriers to efficient and effective development and implementation of POCTs. It is important to consider their needs when adapting POCTs in LMICs and diverse settings.

The growing advancement of innovative stem cell technologies requires careful evaluation of their economic, clinical and societal impacts. Early economic evaluations are essential for developing new medical technologies and supporting key decisions about commercialisation and market access. This scoping review explores Early Health Technology Assessment (eHTA) approaches specifically related to human stem cell technologies. By examining how eHTA can support the commercialisation of these therapies, we aim to clarify its role in optimising resource allocation and enhancing both the clinical and societal benefits of stem cell technologies.

To explore the use of eHTA in the development of stem cell-related technologies, a scoping review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses - Scoping Review Extension guidelines. Systematic searches were conducted across scientific databases (MEDLINE, International HTA database, EconLit, PAIS Index and EconPapers), grey literature sources (Overton) and through hand-searching to identify eligible articles published from inception to 14 April 2026. No limits were imposed on language. Reviewers will independently record data from eligible studies using a standard data abstraction form. The gathered information will be synthesised both quantitatively and narratively.

Formal ethical approval is not required, as this study does not involve the collection of primary data. The findings will be shared through professional stem cell networks, published in national and international health technology assessment conference proceedings and submitted for open-access, peer-reviewed publication.

The survival rate of patients with life-threatening diseases primarily depends on the speed of diagnosis. Too often, diseases are detected only after symptoms appear, which usually occurs at later stages of a disease when available treatments may be less effective. Current detection techniques primarily depend on identifying metabolites in biofluids such as blood and urine. The analysis of these fluids is typically performed in laboratories, resulting in lengthy waiting times for patients to receive their results. In severe cases, invasive biopsies and radiative methods are used to diagnose conditions such as cancer. These biopsies can cause distress for patients who are already experiencing significant emotional or physical stress, while imaging techniques involving ionising radiation may pose additional health risks. Additionally, these methods can be costly. In recent years, exhaled breath has become a biofluid matrix of interest for disease detection, allowing for the identification of volatile organic compounds (VOCs) or VOC profiles associated with specific conditions. To improve early disease detection through breath analysis, the VOCORDER project aims to develop a device that provides a fast, simple, user-friendly and cost-effective method for continuous health monitoring to identify diseases in their early stages before symptoms appear.

A literature review was initially conducted to identify five reference diseases of interest (lung cancer, stomach/colon cancer, breast cancer and kidney insufficiency) and previously reported VOC profiles associated with these diseases. In this trial, the project team from the MITERA Hospital will select patients, and the hospital staff will conduct personal interviews with these subjects. Each participant will also complete a questionnaire for the acquisition of demographic and medical history data, after being informed in detail about the purposes of the questionnaire and signing a consent form. The study protocol consists of two phases. Phase 1 is a baseline study designed to detect and identify breath biomarkers for the early diagnosis of the diseases mentioned above using gas chromatography-mass spectrometry (GC-MS) and secondary electrospray ionisation high-resolution mass spectrometry (SESI-HR-MS). Prescreening will select 120 healthy controls and 175 patients for the baseline phase of the clinical trial, for which breath samples will be collected in 1 L Supel-Inert Multi-Layer Foil gas sampling bags. New biomarkers and VOC profiles will be extracted from these data, and further statistical analysis will allow for artificial intelligence (AI) models to be produced and tested. For phase 2 (validation phase), 120 healthy controls and 100 patients will be selected. Breath samples will again be collected in 1 L gas sampling bags for analyses with GC-MS and SESI-HR-MS. The VOCORDER device will also be used, and its functioning with the newly developed AI models will be evaluated.

This clinical study has been approved by the scientific council at the MITERA hospital in Athens, Greece (#513/2024). The outcomes will be disseminated through peer-reviewed journal publications and presentations at scientific conferences.

NCT06711939.

Maternal and newborn morbidity and mortality are a global concern. Understanding the epidemiology of post-discharge complications could identify opportunities for interventions. We aimed to quantify mortality, care-seeking events and readmission among mothers and newborns in Uganda following facility-based delivery.

This prospective observational study (Apr 2022-Sep 2023) enrolled women presenting for delivery at two regional referral hospitals in Uganda. Data were collected during admission and 6 weeks after delivery by phone.

Overall, 7131 women delivered 7359 newborns, of whom 7129 (99%) women and 6968 (94%) newborns were discharged alive. The newborn mortality rate was 2.7% and 32% of deaths occurred post-discharge. Following discharge, 230 (3%) women and 287 (4%) newborns were readmitted. Suspected sepsis and infections were the most common reasons for readmission among mothers (62.2%) and newborns (89.9%). Caesarean delivery (OR:2·26 (1·75-2·93)) and perinatal death (OR:3·18 (2·09-4·69)) were associated with post-discharge maternal readmission. Both maternal and newborn readmission were associated with household food insecurity during pregnancy (maternal OR:1·56 (1·15-2·08); newborn OR: 1·73 (1·31-2·25)). Newborn resuscitation with oxygen was associated with maternal readmission (OR:2.24 (1.24–3·78)), newborn readmission (OR: 2·74 (1·54-4·56)) and newborn death (OR: 4·01 (1·73-8·21)). Although >99% of women had ≥1 antenatal care visit, only 511 (7%) had ≥1 routine postnatal care visit. There were no routine postnatal care visits among 211 (91·7%) readmitted mothers, 276 (96·2%) newborns and 57 (91·9%) newborns who died.

Post-discharge complications occur in a context of low routine postnatal care use. Risk-informed discharge planning, postnatal care and health education strategies may improve outcomes in mothers, newborns and their families.

Proactive deprescribing is the process of stopping a medicine and comprises four steps: (1) identify a patient for potential stop of a medicine, (2) evaluate a patient for potential stop of a medicine, (3) stop a medicine and (4) monitor after stopping.

The CHARMER (CompreHensive geriAtRician-led MEdication Review) trial is a stepped-wedge design to evaluate the effectiveness and cost-effectiveness of a behaviour change intervention to increase proactive deprescribing in hospitals. The CHARMER intervention comprises a deprescribing action plan, deprescribing briefings, videos of successful deprescribing consultations, deprescribing case studies workshop and a deprescribing performance dashboard. The process evaluation will explore trial processes, CHARMER intervention implementation, CHARMER behavioural mechanisms of action and contextual factors influencing these aspects.

The convergent parallel design process evaluation will follow the UK Medical Research Council guidance. We will interview: staff involved in CHARMER implementation, geriatricians and pharmacists who receive the intervention and research delivery staff involved in patient/carer recruitment and data collection. We will also interview patients/carers and primary care practitioners. Interviews will be supplemented with recordings of implementation activities and completed implementation manuals. Questionnaires will capture the extent to which the four proactive deprescribing steps are enacted by intervention recipients, measure the behavioural mechanisms by which the CHARMER intervention operates and capture the patient experience of proactive deprescribing. Qualitative data will be analysed thematically and then mapped to Normalisation Process Theory to explore implementation and the Theoretical Domains Framework to explore behaviour change. Most quantitative data will be analysed descriptively; however, changes in staff questionnaire responses preintervention and postintervention will be analysed using a Mann-Whitney test. We will triangulate qualitative and quantitative findings to explain intervention effects.

Ethical and governance approvals have been obtained by the Wales 2 Research Ethics Committee and the Health Research Authority, respectively. The dissemination strategy will be underpinned by the evidence-based Guide to Disseminating Research (GuiDiR) targeting healthcare practitioners, policy makers and patient-facing organisations.

ISRCTN13248281.

Asthma is one of the most prevalent long-term health conditions affecting pregnant women. Poorly controlled asthma during pregnancy is associated with adverse maternal and fetal outcomes and may predispose offspring to long-term respiratory morbidity. The current ‘one size fits all’ approach to asthma management during pregnancy is not optimally effective for approximately half of the pregnant women with asthma. A personalised medicine approach to managing airways disease is required. The treatable traits approach focuses on the identification and treatment of traits in the pulmonary, extra-pulmonary and behavioural domains, which are identifiable, measurable, clinically relevant (linked to exacerbation risk or poor asthma control) and treatable. This manuscript outlines the protocol for the Treatable Traits for Asthma Management in Pregnancy (TTAP) study. The purpose of the TTAP study is to prospectively determine the prevalence of a range of treatable traits from these three domains in pregnant women with asthma and determine which traits are associated with exacerbation risk, poor asthma control and poor asthma-related quality of life. Additionally, this study will assess differences in trait prevalence and clinical relevance in pregnant women from regional versus metropolitan hospitals in Australia and in different antenatal models of care.

The TTAP study is a multicentre, prospective observational cohort study. Study participants are pregnant women with asthma attending antenatal clinics at 10 metropolitan and regional hospitals (public and private) in NSW and Victoria, Australia. Assessment of traits from the pulmonary, extrapulmonary and behavioural domains as well as asthma outcomes is conducted at three gestational timepoints: 12–16 weeks, 22–26 weeks and 32–36 weeks of pregnancy. A follow-up assessment of asthma outcomes is conducted at 2–4 weeks postpartum. The outcomes assessed are asthma exacerbations requiring medical intervention (primary outcome), asthma symptom control and asthma-related quality of life. Traits and outcomes will be assessed using questionnaires, direct questioning, measurement of biomarkers, physical measurements and assessment of routinely collected data from medical records.

The Hunter New England Human Ethics Committee (2024/ETH01289) has approved the TTAP study protocol. Outcomes will be published in peer-reviewed journals, presented at scientific conferences and disseminated online to participants, clinicians and other pregnant women with asthma and their families via the Asthma in Pregnancy Toolkit website https://asthmapregnancytoolkit.org.au/.

Intracerebral haemorrhage (ICH) accounts for approximately 15% of all strokes in Denmark and remains associated with high mortality and morbidity. It is challenging to distinguish neoplastic from non-neoplastic causes of ICH in the acute setting, and CT findings that may aid early differentiation have not been fully characterised. Existing ICH-classification systems (SMASH-U, H-ATOMIC and CLAS-ICH) have not been directly compared for diagnostic accuracy in this setting. Identifying radiological and clinical factors associated with underlying aetiology may support faster diagnosis, reduce time to workup related to potential underlying cancer and facilitate early targeted treatment of the underlying cause of ICH.

This study is a retrospective observational cohort including all patients admitted with acute ICH to the Department of Neurology, University Hospital of Southern Denmark, Aabenraa between January 2014 and December 2024 (estimated approximately n=610). Medical records and initial non-enhanced CT scans will be reviewed. Two neurologists and two radiologists, blinded to final diagnosis, will independently extract clinical presentation, topographical and volumetric haemorrhage characteristics, and classify each case using the abovementioned ICH-classification systems. Primary analyses will assess associations between clinical and radiological features and underlying neoplastic vs non-neoplastic aetiology. Secondary analyses will compare diagnostic performance of classification systems using sensitivity, specificity and receiver operating characteristic curves. Multivariate logistic regression models will be applied with Holm correction for multiple comparisons.

The study has been submitted to the National Danish Research Ethics Committee and the Danish Data Protection Agency. As data derive from completed disease courses, no patient contact is expected. Results will be disseminated through peer-reviewed journals, conferences and scientific presentations.

The United Nations (UN) Sustainable Development Goal 6 seeks to ensure universal access to safe drinking water by 2030, but vast inequities in access exist, especially among vulnerable communities including limited resource, rural, disaster-affected areas. Flood disasters, exacerbated by the climate crisis, hinder the ability of individuals and families to meet essential drinking water needs and increase their susceptibility to waterborne illnesses. Point-of-use (POU) water treatment is an effective solution for water-insecure populations during and immediately following flood emergencies. However, an initial literature search identified knowledge gaps surrounding implementation of POU water systems. This scoping review aims to synthesise published evidence between January 2015 and July 2025 on barriers and facilitators to utilisation of POU water treatment systems during and immediately following flood-related disasters. The findings will inform efforts to promote resilience and agency among water insecure communities, specifically by equipping them with actionable knowledge on sustainable access to safe drinking water.

This scoping review will be guided by the work of Arksey and O’Malley and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews. Search terms will be identified through an iterative process using the PICOT method and Boolean logic. Four databases—Scopus, PubMed, Web of Science and Google Scholar—with the addition of grey literature from UN agencies and non-governmental organisations focused on water-related issues will be searched. Two independent reviewers will apply a priori eligibility criteria to select studies. Conflicts will be resolved through discussion and a third independent reviewer absent agreement between the first two reviewers. Cohen’s kappa statistic will be calculated to assess inter-rater reliability. Data extraction will be guided by predefined data points, and the Consolidated Framework for Implementation Research will guide evidence synthesis through a solution-based approach.

Institutional research ethics review is not required because no human subjects are involved. Findings will be disseminated through a peer-reviewed publication, a policy brief, conference presentations and infographics for use by organisations serving flood disaster impacted communities.

Loneliness and social isolation are increasingly recognised as determinants of cardiovascular and brain health, particularly among older adults. Evidence from high-income settings links social disconnection to higher risk of coronary heart disease, stroke, cognitive decline and mortality, yet few interventions have been adapted for rural, resource-limited environments. In rural coastal Ecuador, demographic stability, low migration and strong community engagement provide a unique context to evaluate a culturally grounded intervention. This study aims to determine whether a multi-component social connection intervention programme (SCIP), informed by the Social Cognitive Theory, can reduce loneliness and social isolation and improve cardiovascular, cognitive and psychosocial outcomes among older adults living in three rural villages participating in a population-based cohort.

This quasi-experimental matched-control study will be conducted in Atahualpa (intervention site) and the neighbouring villages of El Tambo and Prosperidad (control sites). Eligible participants are adults aged ≥60 years without disability, dementia or major psychiatric illness. Intervention participants will be matched to controls using variable-ratio propensity score methods. The 12-month SCIP includes monthly community educational activities, peer-support group sessions and individualised coaching (two times per month) focused on skill-building, goal-setting and cognitive-behavioural strategies. Participants in the control villages will receive usual community and primary care services without exposure to SCIP activities. Baseline and 12-month assessments will measure social isolation, loneliness, cardiovascular health, sleep quality, cognitive performance, depressive symptoms and quality of life. Incident stroke, cardiovascular disease and mortality will be monitored quarterly. Analyses will use mixed-effects models for continuous and categorical outcomes and Cox proportional hazards models for incident events, adjusting for relevant confounders.

The protocol was approved by the Ethics Committee of Hospital-Clinica Kennedy, Guayaquil. All participants will provide written informed consent. Findings will be disseminated through peer-reviewed publications, conference presentations and community reports. Results may inform scalable strategies to enhance psychosocial well-being and reduce cardiovascular and cognitive risk in underserved rural populations.

NCT07319663.

The transition from hospital to home is a vulnerable stage in the patient pathway. Patients and carers often report unmet information needs regarding diagnoses, medication changes, follow-up arrangements and escalation pathways during the post-hospital discharge period. Digital information interventions—such as electronic health records, patient portals or remote communication systems—have been proposed to improve discharge pathways. However, evidence on their impact is unproven. The aim of this review is to understand what works for whom, how, why and in what circumstances in relation to digital information interventions during the hospital-to-home journey.

Pawson’s realist review approach will be used. The Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols and Realist and Meta-narrative Evidence Syntheses: Evolving Standards quality and reporting standards will also be followed. The review will follow five steps: (1) Development of the initial programme theory; (2) evidence search; (3) selection and appraisal of data; (4) extraction and organisation of data and (5) data synthesis and analysis. The search will be conducted in MEDLINE (Ovid); Embase; PsycINFO; Web of Science and Cochrane Library and supplemented with citation tracking, grey literature, relevant organisational websites, programme evaluation reports and through consultation with stakeholders. The realist review will be an iterative process, and the initial realist programme theory will be tested (confirmed, refuted or refined) in response to the data searches and stakeholder discussions. Patient and public involvement and engagement will be embedded throughout the review. Patients, carers and health and care stakeholders will contribute to refining the initial programme theory, interpreting emerging programme theory and co-developing dissemination outputs to ensure findings remain grounded in lived realities.

Ethical approval is not required for this review as it involves secondary analysis of published literature. The review will be conducted in accordance with principles of research integrity, transparency and responsible stakeholder involvement. Findings will inform the co-design of future digital discharge interventions and contribute to national priorities around digital transformation, safety and equity in transitional care. Dissemination will include conference presentations, a peer-reviewed journal article and accessible summaries co-developed with stakeholders to support equitable implementation and impact.

Fibromyalgia is a polysymptomatic central sensitisation disorder characterised by widespread pain, fatigue, sleep disturbances and neuropsychiatric features. Hyperbaric oxygen therapy modulates neuroinflammation, mitochondrial function and neuroplasticity, thereby yielding analgesic and functional benefits.

Evaluate the efficacy and optimal timing of hyperbaric oxygen therapy as an adjunct to standard care for fibromyalgia.

This single-centre, randomised, cross-over group, assessor-blinded clinical trial was conducted in the Department of Rheumatology at the University Hospital of the Federal University of Juiz de Fora, Juiz de Fora, Brazil, and adhered to Consolidated Standards of Reporting Trials (CONSORT) guidelines. Women (18–70 years) with a diagnosis of fibromyalgia for ≥2 years were randomised 1:1 to early hyperbaric oxygen therapy plus standard care or standard care alone (delayed group). Intention-to-treat (ITT) analysis was conducted with all 56 participants (mean age: 51.0±9.8 years; mean body mass index: 30.5±5.1 kg/m²).

Standardised care (education, exercise and pharmacotherapy) plus hyperbaric oxygen therapy was delivered at 2.3 atmospheres absolute for 90 min, five times per week, over 8 weeks (total 32–40 sessions). The early group received hyperbaric oxygen therapy during weeks 0–8, while the delayed group received it during weeks 8–16, following the same protocol.

Primary endpoints included the Fibromyalgia Impact Questionnaire-Brazilian Portuguese (FIQR-Br), the pain visual analogue scale (VAS) and the Symptoms Assessment Scale-40 (EAS-40) for psychopathology. Secondary endpoints included the 12-Item Short-Form Health Survey (SF-12) physical and mental components and adverse effects. Assessments were conducted at baseline, 8 weeks and 16 weeks, and analysed using a mixed-design 2x3 analysis of variance (group: early vs delayed; time: baseline, 8 weeks and 16 weeks) with Greenhouse-Geisser corrections as needed, followed by Bonferroni post hoc tests. Missing data were assessed using Little’s missing completely at random (MCAR), and considering the ITT analysis, the means imputed for missing data were estimated through expectation maximisation. Effect sizes were reported as partial ² and Cohen’s d with α=0.05.

44 participants completed the study, and the overall withdrawal rate was 21.4% with no baseline between-group differences. Significant time effects were observed for all primary outcomes and the SF-12 outcome (pxtime interactions were significant for FIQR-Br, VAS, EAS-40 and SF-12 physical and mental (p≤0.02; interaction ² up to 0.23), indicating improvements during active hyperbaric oxygen therapy exposure. Compared with standard care alone over 8 weeks, combined treatment achieved greater gains: FIQR-Br, –31.1% vs –14.4%; VAS, –54.0% vs –33.5%; EAS-40, –28.4% vs –3.7%; SF-12 physical, +39.1% vs +14.8%; SF-12 mental, +57.4% vs +31.9%. Large within-group effect sizes were observed (eg, VAS d=2.5–2.7; FIQR-Br d=1.4–1.7). Efficacy was equivalent regardless of time started, and the benefits converged by the end of each hyperbaric oxygen therapy phase. After stopping hyperbaric oxygen therapy, the FIQR-Br and SF-12 mental component scores regressed towards standard care levels, whereas residual improvements persisted for up to 8 weeks in VAS, EAS-40 and SF-12 physical component scores. Adverse events were infrequent; one case of otalgia required extended management. Withdrawals were primarily due to non-compliance or intolerance to chamber confinement. No serious or unexpected safety concerns were reported.

Hyperbaric oxygen therapy, delivered under a standardised protocol, is an effective and well-tolerated adjunct to multimodal fibromyalgia care. Timing can be individualised: early initiation for rapid relief or stepped introduction after optimised usual care, with comparable overall efficacy. The durability of the benefit appears to be exposure dependent, and maintenance or booster schedules merit further evaluation.

RBR-6prps8g.

Academic medical careers remain marked by persistent gender inequalities, despite the growing feminisation of the medical workforce. The objective of this study was to examine whether gender differences exist in key individual and institutional determinants of academic medical career aspirations among medical residents, including research motivation, mentoring, work centrality, self-efficacy, perceived discrimination and stress.

This was a national cross-sectional online survey.

Multicentre study conducted across 36 medical schools in France.

A total of 1570 medical residents (997 women and 573 men) voluntarily participated between November 2022 and February 2023. All participants completed validated self-report questionnaires. There were no exclusion criteria beyond being enrolled in a French residency programme.

Attitudes towards research (interest, motivation, significance) were measured using the Scale of Attitudes towards Research. Mentoring was assessed with the Mentor–Mentee Perception Questionnaire, work centrality with Hirschfeld and Feild’s scale, self-efficacy with the General Self-Efficacy Scale, perceived discrimination with the Sexual Harassment and Discrimination Experiences of Academic Medical Faculty instrument and stress with the Perceived Stress Scale. Gender differences were analysed using t-tests or ² tests with Holm-Bonferroni corrections for multiple comparisons.

Compared with men, women reported lower research motivation (mean (SD) 21.0 (5.5) vs 22.8 (5.5); p_adj=0.011), lower research interest (27.1 (5.5) vs 28.1 (5.7); p_adj=0.011), lower work centrality (26.7 (7.0) vs 28.2 (8.1); p_adj=0.011) and lower self-efficacy (28.3 (5.2) vs 29.9 (5.0); p_adj=0.011). Women were less likely to report having a mentor (38.5% vs 44.5%; p_adj=0.02). They also reported substantially higher levels of experienced gender discrimination (22.8% vs 3.8%; p_adj=0.005), sexual harassment (57.7% vs 18.2%; p_adj=0.005) and perceived stress (8.48 (3.29) vs 7.27 (3.43); p_adj=0.011)

Gender differences were observed across several individual and institutional factors associated with academic medical career aspirations. Reduced access to mentoring and greater exposure to discrimination and stress among women may contribute to lower research motivation and self-efficacy. These findings highlight the need for institutional strategies addressing mentoring, workplace culture and equity to support gender parity in academic medicine.

OSF preregistration for this study is available at https://osf.io/9yseq/?view_only=1c72743f542b402ba67beed6908e597d

Sports-related concussion (SRC) is an established research topic in the context of sport professionals suffering from mild traumatic brain injury (mTBI), but there is scant investigation of SRC arising in school-aged athletes. Effective management of SRC in adolescents is especially dependent on obtaining an understanding of its pathophysiology and the multifaceted nature of recovery. In this planned observational study, we shall investigate the associations among multimodal data comprising blood-based and saliva-based biomarkers, diffusion tensor imaging (DTI), quantified susceptibility imaging (QSM), resting state functional connectivity MRI (rsfMRI) and cognitive testing in school rugby players with a conventional diagnosis of concussion. Our objective is to map out a natural history of the post-concussion injury and recovery process as measured by diverse biomarkers.

This prospective cohort study will enrol 450 male adolescents who participate in sports (including rugby, basketball and swimming). We shall quantify blood biomarker levels (total tau, neurofilament light, glial fibrillar acidic protein and ubiquitin C-terminal hydrolase-L1), white matter integrity on DTI, cerebral venous oxygen saturation on QSM, connectivity metrics on rsfMRI and cognitive performance after SRC. We conduct measurements at pre-injury baseline measure and post-SRC at four to five pivotal times: day 1 (day of injury), 3, 6, 13 and 21 (if symptoms persist) post-concussion. Using mixed-effects and trajectory modelling, we shall assess biomarker trajectories.

We have secured ethical approval for this study from The University of Queensland’s Human Research Ethics Committee, Queensland. We shall inform participants and/or their guardians verbally and in writing of the study’s scope and procedures as a condition for informed consent. The dissemination of findings shall entail peer-reviewed publications and presentations at national and international conferences and via research and clinical networks. Completion of this study should provide a clearer understanding of anatomic and functional outcomes in adolescents with sports-related concussion.

The multimodal investigation of a cohort of adolescents suffering from concussion in the context of community sports should offer broad insight into the effects of mTBI on the developing brain.

The BioCaPPE (Biomarkers of Prostate Cancer/Prevention and Environment) study is a multicentre prospective observational cohort designed to identify biomarkers associated with prostate cancer (PCa) risk that may be modifiable through lifestyle factors. This paper describes the cohort, along with the data and bio-samples available for future studies in PCa risk assessment.

Canadian men at risk of PCa were enrolled based on one of two criteria (1) negative first prostate biopsy within 6 months from enrolment (Group 1); or (2) a prostate-specific antigen (PSA) blood level between 2.5 and 10 ng/mL without prior prostate biopsy (Group 2). At baseline, blood samples and comprehensive data were collected. PCa incidence and lifestyle factors were updated for all participants over 2 years, with extended follow-up for those who provided additional consent.

Recruitment was conducted across four health centres in Quebec, Canada. A total of 2053 men were enrolled—1499 in Group 1 and 554 in Group 2. All participants completed the initial visit, which included collection of medical and family history, anthropometric measurements, demographic information, dietary and alcohol intake, physical activity, tobacco use, medication use, and quality of life assessments, and candidate biomarker measurements. At the 2-year mark, 7.2% of participants had developed PCa; this figure has since increased to 15.3% (median follow-up: 6.1 years). Additionally, 84% (n=1718) consented to ongoing annual follow-up.

This large, prospective cohort of men at risk of PCa offers valuable resources for risk stratification and primary prevention. The BioCaPPE biosamples and data are available to support the identification of lifestyle-related biomarkers associated with PCa risk in this population.

ClinicalTrials.gov Identifier: NCT03383016.

Hypertensive disorders of pregnancy, such as pre-eclampsia (PE), are one of the leading causes of maternal and perinatal deaths in low- and middle-income countries (LMICs). Although clinical practice guidelines (CPGs) for PE prevention and management are available, there is limited information on their implementation in LMIC contexts. This realist synthesis therefore aims to uncover the causal explanations underpinning the implementation of CPG recommendations for PE prevention and management in Eastern, Central and Southern African contexts. By developing and refining initial programme theories (IPTs), we will generate a pragmatic evidence base explaining how contextual factors trigger mechanisms that lead to intended and unintended outcomes and why implementation varies across the different settings.

We conceptualise the implementation of CPGs for PE prevention and management as complex social interventions operating within complex adaptive systems. The realist synthesis method will be employed to systematically review the literature for evidence synthesis. The review process will be conducted in five phases, each iteratively building on the previous phase to uncover generative causation and refine the IPTs. We will identify articles through iterative purposive searching in six electronic databases and search engines (Google Scholar, PubMed, Cochrane, MEDLINE, EMBASE Global Health) and through screening WHO sources. Advisory group consultations will be held to formulate, prioritise and refine IPTs. To conceptualise our realist theories through generative causation, we will analyse the data using a retroductive approach, an integration of inductive, deductive and abductive reasoning. We will inductively examine theoretical insights related to five established care moments and explore how CPGs operate during these moments, including where and how they fail to work as intended. The five care moments are: (1) Risk assessment/prevention, (2) Diagnosing disease, (3) Management of PE without severe features, (4) With severe features and (5) Decision making around birth. Deductive reasoning will support sense-making of evidence-based theories through the lens of theories that have been used to explain the adoption of guidelines in healthcare settings. Lastly, abductive reasoning, centring researcher hunches, will help to unearth mechanisms that have been insufficiently detailed in the literature. The intervention-context-actor-mechanism-outcome heuristic will be used to configure programme theories and articulate the theories using the if-then statements.

This project is part of the larger PREvention of Severe Hypertensive Adverse events (PRESHA) project, which aims to improve the detection, prevention and management of PE in Tanzania. PRESHA has ethical clearance from the Regional Ethics Board in Norway and the National Health Research Ethics Committee in Tanzania. Findings of the review will support the contextual development of CPGs for the prevention and management of PE, which will be implemented within the context of the PRESHA trial.

Iron-folic acid (IFA) supplementation in pregnancy is recommended by the WHO, with a dose of 60 mg of iron in contexts where anaemia remains a severe public health problem. Iron-containing supplements may cause side effects that affect acceptability and adherence in a dose-response manner. Maternal multiple micronutrient supplements (MMS), which include iron and folic acid plus additional micronutrients, are also recommended in the context of rigorous research, and programmes are considering transitioning from IFA to MMS containing 30 mg of iron. We will evaluate the effect of iron dose in MMS on maternal acceptability, side effects, adherence and preferences.

The Multiple Micronutrient Supplementation (MMS) Iron Dose Acceptability Crossover Trial is an individually randomised, quadruple-blind, non-inferiority crossover trial of daily antenatal MMS supplementation formulations that contain 60 mg, 45 mg and 30 mg elemental iron among pregnant women in Dar es Salaam, Tanzania. A total of 156 pregnant participants will be randomised to a sequence in which they receive each of the three MMS formulations for 1 month. Participants, investigators, outcome assessors and data analysts will be blinded to the treatment sequence. The primary trial outcome is participant-reported acceptability of each MMS formulation, measured on a Likert scale. Secondary and tertiary outcomes include preferred and least preferred formulation, identification of MMS formulation, reported side effects and adherence assessed by pill count. Regression analyses will be used to assess differences between formulations and will account for sequence and period effects of the crossover trial design. Qualitative in-depth interviews from a subsample of participants will be conducted to understand women’s perceptions and experiences taking the different MMS formulations.

The trial protocol was approved by Harvard T. H. Chan School of Public Health Institutional Review Board (IRB), the Ifakara Health Institute IRB, the Muhimbili University of Health and Allied Sciences IRB, the National Health Research Ethics Sub-Committee and the Tanzania Medicine and Medical Device Authority. Results will be shared through publications and presentations at the local, regional and international levels.

ClinicalTrials.gov Identifier: NCT06069869.

In sub-Saharan African countries, the population-based assisted vaginal birth (AVB) rate is approximately 1% as compared with 16% in Western Europe. Consequently, women experiencing prolonged labour often face limited access to prompt intervention, leading to maternal and perinatal complications or unnecessary caesarean sections (CS). The OdonAssist device has been developed to be safe, user-friendly and more acceptable than currently used AVB devices. We propose to conduct a study in Ethiopia to evaluate if the implementation of this innovation is feasible and may contribute to improving the access to AVB while reducing unnecessary CSs.

We designed a single-centre feasibility study at Saint Luke Catholic Hospital (Wolisso, Ethiopia), a secondary facility where AVB is routinely performed by midwives and health officers under gynaecologist supervision, reflecting the local health system. Following a quasi-experimental design, we will include three groups of 20 women: an intervention group (OdonAssist), a vacuum extraction cohort and a control group of second-stage CS (performed without a prior trial of instrumental birth). The primary objective is to assess the clinical and methodological feasibility of the OdonAssist by collecting preliminary data on safety, acceptability and quantifying potential efficacy relative to the current standard of care. An exploratory economic evaluation of direct healthcare costs will be performed.

Approved by the Oromia Regional Health Bureau. The study results will be published in peer-reviewed journals to inform future impact evaluations of the OdonAssist device in global maternal and perinatal health.

NCT06918509.

Ageing is associated with declines in physical and cognitive function that increase the risk of disability and dependence. Intrinsic capacity (IC), proposed by the WHO, provides a multidimensional framework to assess health in older adults. This study aims to evaluate whether a multicomponent recreational exercise programme (Fun Exercise for Older Adults (FEXO)) improves IC, motivation and adherence compared with a conventional programme (OTAGO).

A randomised controlled trial with two groups (2:1 ratio) will be conducted among 120 community-dwelling older adults (≥60 years). Participants will be randomly assigned to FEXO (intervention) or OTAGO (control). Both programmes will consist of 3 weekly sessions for 14 weeks. Primary outcomes: IC, assessed through validated measures (Short Physical Performance Battery, Mini Nutritional Assessment, Mini-Mental State Examination, Cornell Scale for Depression in Dementia and sensory evaluation), motivation (BREQ-3) and adherence rate. Secondary outcomes include body composition, cardiovascular parameters, frailty, cognition and resilience (PRIFOR). Data will be analysed using two-way ANOVA (groupxtime) under an intention-to-treat approach. Effect sizes (p²) and 95% CIs will be reported. Additional analyses (correlation, regression, mediation and moderation) will explore associations and intervention effects.

Approved by the Ethics Committee of Universidad CEU Cardenal Herrera (Ref. CEEI23/487 and CEEI25/639). Results will be disseminated through peer-reviewed journals and scientific conferences. The findings of this study will contribute to improving evidence-based strategies for promoting healthy ageing and will support the development of more engaging and effective exercise interventions for older adults.

This study has been prospectively registered at ClinicalTrials.gov (identifier: NCT07133568).

To develop a core information set for induction of labour. Rates of induction of labour for childbirth are rising in many high-income countries. In England, a third of women have their labours induced. National guidelines recommend women receive information to make informed decisions about induction.

Two-stage consensus study using modified Delphi.

UK.

Pregnant people, parents and professionals.

Stage 1: A long list of information points was identified through a systematic review of reviews, reviewing patient leaflets, qualitative interviews and a stakeholder survey, with ongoing patient, public and professional involvement. Stage 2: Think-aloud interviews were undertaken to refine the Delphi survey before a two-round modified Delphi process where participants voted on the importance of the information items. Pre-specified criteria were used to select items taken forward to a consensus meeting.

199 information points were identified through systematic review (110), patient information leaflets (162), qualitative interviews (58) and a survey (93). 46 unique information items entered the first Delphi round after four think-aloud interviews, 2 items were added following round 2. 368 people (310 parents/58 professionals) participated in round 1 and 177 people (154 parents/23 professionals) in round 2. 44 items met inclusion criteria; one item excluded, and three items were carried forward for consensus meeting discussion where 12 overarching information points were agreed on.

This study has established a consensus-based core information set for induction of labour from a sample of the birthing population and staff providing their care. The resultant set has been populated with evidence in line with national guidelines. It can be used by women and clinicians as a standardised starting point from which to personalise discussions about birth.

COMET Initiative registration 2600: Developing a core information set for induction of labour.