Pregnancy in women with pre-existing type 1 or type 2 diabetes (T1D, T2D) is associated with increased risk of complications, largely driven by maternal glucose control. Hormonal changes during pregnancy make glucose management more challenging. Physical activity (PA) may improve glucose control and reduce complications; however, little is known about PA patterns in this population and no pregnancy-specific PA guidance exists for women with pre-existing diabetes. Understanding the behaviours and experiences of both pregnant women and the healthcare professionals (HCPs) who support them is needed to inform evidence-based guidance.

This mixed-methods study comprises three sub-studies. The first will recruit 175 pregnant women (75 with T1D and 100 with T2D) who will complete three 7-day monitoring periods, one per trimester. PA will be assessed using wrist-worn accelerometers and exercise diaries, dietary intake via remote food photography, and corresponding continuous glucose monitor and diabetes-related well-being data will be collected.

The second involves a subsample of ~16 women participating in focus groups to explore experiences of being physically active during pregnancy.

The third invites ~100 HCPs involved in diabetes in pregnancy care to complete an online survey, ~10 HCPS will take part in an optional interview about their experiences of providing PA guidance.

The primary outcome is the change in PA across pregnancy. Secondary outcomes include associations between PA, glucose metrics, diet and diabetes-related well-being, and qualitative themes relating to experiences of women and HCP. Quantitative data will be analysed using multilevel modelling and regression analysis, and qualitative data using reflexive thematic analysis.

Ethical approval was granted by the East Midlands Nottingham 1 Research Ethics Committee (25/EM/0190) and University of Exeter Public Health and Sport Sciences ethics committee. Findings will be disseminated through peer-reviewed publications and conference presentations.

The initiation of buprenorphine for patients with opioid use disorder (OUD) in the emergency department (ED) has been associated with improved outcomes including reduced ED visits and increased treatment engagement. Though both standard-dose (8 mg buprenorphine equivalent) and high-dose (24 mg buprenorphine equivalent) strategies to initiate buprenorphine have been used in the ED, no prospective trials comparing outcomes among patients receiving these treatments have been reported.

This multisite randomised clinical trial is a multisite double-blind, double-dummy, randomised clinical trial enrolling 360 emergency department patients with moderate-to-severe OUD. Enrolled patients will be randomised to one of two study arms: standard-dose induction or high-dose induction, both provided in the ED. This study will engage, train and provide resources to five EDs throughout the US to recruit patients with untreated OUD into a randomised clinical trial. The primary aim is to evaluate the effects of the standard-dose induction and high-dose induction on rates of OUD treatment participation within 10 days post-randomisation. The secondary aims are to evaluate differences between standard-dose induction and high-dose induction on the outcomes of opioid craving, opioid withdrawal symptoms and illicit drug use assessed during 10 days post randomisation and evaluate the effects between treatment arms on rates of OUD treatment participation within 30 days post randomisation.

This study is funded by the National Institute on Drug Abuse and has been approved by the WCG Instutitional Review Board. It has been registered at clinicaltrials.gov. This study will inform the strategy for treatment initiation with buprenorphine among diverse ED settings and will provide ongoing evidence to support the safety and efficacy of initiating treatment for OUD in the ED.

NCT06494904.

To explore healthcare professionals’ perspectives on the potential role of molecular breast imaging (MBI) for breast cancer imaging and to inform future clinical study design and implementation.

Qualitative interview study.

UK National Health Service (NHS) breast screening and diagnostic pathways.

Purposively sampled stakeholders.

Semistructured interviews with key professional stakeholders explored potential MBI pathways and routes to adoption, including barriers and facilitators. Data were analysed thematically.

22 participants were recruited between January 2020 and October 2021. Barriers to MBI adoption were identified at three levels: scan-related, system-level, and cultural within the screening programme. Overcoming these is likely necessary for implementation. A further theme highlighted the potential for MBI to improve screening in selected patient groups, contingent on addressing these barriers. Specifically, adoption would require advances in next-generation MBI systems, particularly reductions in radiation dose and scan time, alongside prospective clinical studies in UK populations to assess diagnostic accuracy.

Once identified barriers are overcome, participants perceived that MBI could improve screening pathways, particularly for women with dense breast tissue.

Diabetes mellitus is a highly prevalent metabolic disorder associated with chronic, low-grade inflammation. Of recent interest is the association between diabetes and circadian rhythm disruption. The aim of this review is to evaluate and synthesise clinical evidence for whether diabetes affects homeostatic diurnal patterns to proinflammatory markers in the human body. This could inform the optimal timing of immune-targeted therapies over the course of the day.

This systematic review will include primary clinical research studies reporting on diurnal variations, defined as an afternoon/evening (PM) minus a morning (AM) value, within a timeframe of 12±4 hours, for predefined proinflammatory markers, in individuals with diabetes (type 1 or type 2) compared with healthy controls. A search of online databases (Cochrane CENTRAL, Ovid MEDLINE and Ovid Embase) will be performed. Grey literature searches will be performed in clinical trial registries. Two review authors will independently screen retrieved citation records at the title/abstract and full-text levels. Study quality will be assessed using an appropriate National Institute of Health quality assessment tool. A meta-analysis will be performed if more than one study reports equivalent data for any outcome. Statistical heterogeneity will be assessed using the ² test. Where a meta-analysis is not possible or unlikely to be meaningful, a narrative synthesis of the findings will be provided.

Ethics approval is not required for this systematic review as no original data will be collected. The results will be disseminated through peer-reviewed publication and conference presentations.

CRD420251115780.

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.

Research and mental health services agree that more youth co-production in service design and delivery is needed, but there is little consensus on how to do it well. This study is trying to find agreement about the best ways to do this.

A realist eDelphi study will be conducted. People with experience of co-production and engagement in youth mental health services will be invited to participate. This will include young people with relevant lived experience, family members/carers of young people with mental ill health, youth mental health researchers and other professionals with experience of youth engagement work (eg, mental healthcare staff, mental health service managers and participation/engagement professionals in the sector). The target is to recruit 10–20 participants from each of these four groups (40–80 participants total).

The following steps will be taken: (1) an advisory group of young people will use results from a realist literature review completed prior to this study, to generate the first list of items for the survey; (2) using the online survey tool Qualtrics, participants will be invited to rate these items in an online survey. A prompt question formatted using a realist framework will allow participants to comment on their rating and how this survey item works (or does not work) in this context, for young people or other stakeholders. Participants will be able to add further suggestions at this stage; (3) using Qualtrics, a second survey round will be completed which will include the new suggestions from participants, and original items with their average participant ratings and comments displayed. Participants will be asked to rerate items in this round; (4) a list of items will be generated that comprises survey items believed to be ‘essential’ or ‘important’ by 80% or more of the participants; (5) this list will be discussed with the Youth Advisory Group to generate a final recommendations document and consider creative outputs and dissemination methods. Data analysis will include raw numbers, means and frequencies.

Ethical approval has been granted by the University of Birmingham Research Ethics Committee (Ref: ERN_1550-Apr2024). Both traditional and non-traditional outputs will be created (eg, conference presentations, publications, a plain English summary and social media infographics).

In the UK, a range of services provide same day, urgent and emergency care (UEC). Urgent medical needs can be addressed through pharmacy services, same day general practice (GP) appointments, phone or online triage services, out-of-hours GP appointments and urgent treatment centres (or equivalents). For emergency medical needs, patients can access emergency departments (EDs) and ambulance services. These services are highly vulnerable to excessive strain due to rising, unpredictable demand and limitations in patient flow across the system. The workforce operates in time-critical situations, often with limited resources, which can lead to staff burnout, low job satisfaction and retention and poor health. The organisation of services and their workforce continues to evolve in response to local and national pressures and varies considerably across the UK, where there are four distinct, publicly funded healthcare systems managed separately in each country. This makes it difficult to describe and compare services within and across regions and understand the impact of workforce organisation on service delivery, staff well-being and patient care. This study aims to develop a comprehensive understanding of the range and types of UK UEC services, the relative experiences of the workforce and the available workforce data.

This mixed-methods study includes two components, integrated through an explanatory sequential design. Study 1 will use data on NHS service availability and direct enquiry to map UEC services and populate a structured database, which will facilitate the generation of a UEC typology of the range and types of services and regional variation across the UK. Multiple case studies will be conducted in a subset of services using qualitative interviews (n=136–220) with service leaders (n=3–5), workforce (n=10–12), and patients or carers (n=4–5), as well as document analysis where relevant, in each service of interest (n=8–10). Study 2 will create a metadata catalogue of workforce data and produce descriptive summaries of key metrics (eg, staffing levels and skill mix). The study will be supported by our Community Inclusion and Engagement (CIE) panel and Patient and Public Advisory Group (PPAG) to ensure relevance, inclusivity and impact.

This study received ethical approval from Yorkshire and The Humber - Sheffield Research Ethics Committee (04/08/2025, IRAS ID: 357276, REC Reference: 25/YH/0125) and HRA and Health and Care Research Wales approval (12/08/2025). Data collection poses minimal risk, informed consent will be obtained, and participants may withdraw at any time. Dissemination will follow knowledge mobilisation principles to maximise impact. We will build on our existing networks and work with our CIE panel and PPAG to tailor study outputs to different audiences. The outputs will improve understanding of the variation in how UEC services and workforces are organised across the UK, as well as the type and format of available workforce data, and provide benchmarks for future research.

Research Registry (REF: researchregistry11555; https://www.researchregistry.com/register-now/%23home/registrationdetails/68d402672341e502cd0ce888/)

Across Canadian postsecondary educational institutions, sexual violence persists as a serious yet largely undisclosed harm with profound impacts on students’ mental, physical and academic well-being. Canadian scholarship has not been systemically synthesised to clarify how sexual violence disclosure processes are framed or experienced within postsecondary contexts despite disclosure often being the primary way students seek support. The aim of this scoping review was to: (1) characterise existing perceptions of disclosure within Canadian postsecondary sexual violence evidence; (2) identify key sources and perspectives informing the Canadian postsecondary sexual violence evidence; (3) synthesise reported impacts of disclosure for students pertaining to Canadian postsecondary sexual violence and (4) highlight gaps and research priorities for Canadian postsecondary sexual violence.

A scoping review conducted using Arksey and O’Malley framework, with incorporated enhancements from Levac and colleagues.

Documents published between 1 January 2014 and 7 March 2025 were reviewed. These were located through searches in PsycINFO, ERIC, Sociological Abstracts, Criminal Justice Abstracts and SCOPUS, along with targeted searches of organisational and government websites.

Peer-reviewed and grey evidence in English, published from 2014 onward that addressed sexual violence in Canadian postsecondary settings were included. Eligible evidence included empirical studies, theoretical papers, reviews, dissertations, commentaries, books, book chapters and organisational reports. Letters to the editor, book reviews and conference abstracts were excluded.

Extraction and synthesis examined how disclosure is defined, its purpose, associated barriers and outcomes; the role of intersectionality and power relations; and recommendations to improve sexual violence responses.

A total of 224 documents (164 peer-reviewed articles and 60 grey literature documents) were included in the review. Results indicate disclosure is a complex, iterative process, shaped by systems of power that differentially affect students across intersecting identities. Barriers to disclosure were most often linked to both institutional and structural inequities that influence students’ experiences and outcomes. Findings clarify that advancing the safety of sexual violence response and research depends on centring student perspectives and expertise.

This scoping review provides an overview of the power dynamics and risk involved in sexual violence disclosures among students in Canadian postsecondary institutions. Meaningful and transparent application of intersectional and trauma-informed approaches is critical to supporting epistemic safety and cultivating institutional cultures of care rather than perpetuating further harm for Canadian students.

To investigate how patients with sarcoma present prior to diagnosis—through a general practitioner (GP) or another healthcare professional (HCP)—and describe presenting symptoms.

International observational cohort study.

Data were obtained from the longitudinal ‘QUality of life and Experiences of Sarcoma Trajectories’ (QUEST) cohort study, conducted across the Netherlands, the United Kingdom (UK), Australia and New Zealand.

Among 572 patients, 487 (85.1%) started their diagnostic trajectory at the GP (subcohort 1) and 85 (14.9%) with another HCP (subcohort 2)—mainly medical specialists treating unrelated conditions (36/85; 42.4%). Soft tissue sarcoma patients most often reported swelling, whereas bone sarcoma patients reported unexplained pain. Notably, 31/85 (36.5%) of subcohort 2 were asymptomatic. Reasons for delaying GP visits included assuming symptoms were minor and expecting them to resolve. Patients sought care when, among others, symptoms persisted and worsened.

Most patients first consulted a GP, underlining the role of primary care in sarcoma diagnosis internationally. Due to rarity and nonspecific symptoms, faster diagnosis remains challenging, requiring improvements in both primary and specialist care.

NCT03441906; Results.

The National Health Service (NHS) faces mounting pressure from an ageing population and the backlog of care following the COVID-19 pandemic. The NHS Long Term Workforce Plan sets out a strategic framework to address these pressures through three priorities: train, retain and reform. The plan outlines a range of measures, including the doubling of medical school places over the next decade. Realisation of these ambitions is constrained by limited training capacity, as existing educators face significant pressures due to clinical demands. Clinical Teaching Fellow (CTF) programmes provide resident doctors with protected time for education and may help expand capacity and alleviate workforce pressures on established educators. Despite their rapid growth, CTF programmes remain under-described, and their contribution to NHS workforce priorities has not been systematically examined. To address this gap, this scoping review will map published and unpublished evidence on UK-based CTF programmes, engaging knowledge users to ensure findings are relevant to practice and workforce priorities.

The review will follow the Joanna Briggs Institute methodology for scoping reviews and reported in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) extension for Scoping Reviews. Evidence will be identified from academic databases (British Education Index, EMBASE, ERIC, MEDLINE, Scopus, Web of Science) and grey literature sources (Google Scholar, NHS and medical school websites, deanery pages and job-advertising platforms). Two reviewers will independently screen and extract data using a piloted form, with discrepancies resolved by discussion or a third reviewer. Extracted data will undergo descriptive analysis and narrative synthesis, guided by a Theory of Change framework to identify how CTF programme inputs, activities and outcomes relate to NHS workforce priorities. Knowledge users will be engaged throughout the review to refine research questions, inform source selection, interpret findings, and shape dissemination.

Ethical approval has been granted. All participants will provide informed consent. Participant contributions will be pseudonymised, and data will be managed in accordance with UK data protection legislation. Dissemination will be informed by knowledge users to ensure that findings on CTF programmes, including reported outcomes and identified gaps, are shared with those involved in delivering or supporting CTF programmes and with NHS stakeholders responsible for workforce priorities in training, retention and reform.

Induction of labour (IOL) is a commonly performed obstetric intervention, particularly when delivery is deemed more beneficial than continuing the pregnancy due to maternal or fetal indications. When the cervix is unfavourable for delivery, cervical ripening is performed prior to IOL. A wide variety of mechanical, pharmacological and combination methods are used, but the optimal approach balancing efficacy, safety and patient experience remains uncertain. Conventional aggregate data (AD) meta-analyses lack individual-level data, limiting exploration of patient-level factors for personalised medicine and do not address concerns about the trustworthiness of data presented in peer-reviewed randomised controlled trials (RCTs). This protocol describes an individual participant data (IPD) network meta-analysis (NMA) designed to evaluate and rank cervical ripening methods for IOL using only high quality, trustworthy data.

We will identify eligible parallel-group RCTs enrolling pregnant women with a singleton, cephalic fetus at ≥34 weeks’ gestation requiring cervical ripening, through comprehensive searches of Ovid MEDLINE, Embase, Emcare, Scopus, Cochrane Pregnancy and Childbirth Register, WHO International Clinical Trials Registry Platform, clinicaltrials.gov and reference lists of prior reviews. The interventions we consider will be selected via Delphi consensus with international clinical experts. Eligible trial investigators will be invited to contribute de-identified IPD; AD will be used if IPD is unavailable. Trials will be assessed for trustworthiness using the Trustworthiness in RAndomised Clinical Trials checklist and the IPD Integrity Tool, with only eligible studies included in the primary analysis. All statistical analyses will follow a pre-specified statistical analysis plan (SAP) finalised before any analyses are conducted. A two-stage, contrast-based, frequentist IPD-NMA will compare cervical ripening methods for three co-primary outcomes: vaginal birth, composite adverse perinatal outcomes and composite adverse maternal outcomes. Subgroup analyses will assess effect modifiers (eg, parity, age and previous caesarean), with treatment rankings presented using the surface under the cumulative ranking curve and rank-heat plots. Sensitivity analyses will examine the impact of bias, missing data and population criteria.

This study has been approved by the Monash University Human Research Ethics Committee (No. 48189). IPD will be de-identified and securely transferred for storage on a Monash University-hosted shared network drive. Findings will be disseminated via peer-reviewed publications, conference abstracts and the Cervical Ripening for Induction of Labour Collaborative Evidence Network Meta-Analysis (CIRCLE-NMA) website (https://circlenma.com). Patient and public involvement will guide the communication and interpretation of results.

CRD420251077464.

Community pharmacies are increasingly recognised as accessible providers of public health services. Integrating cardiovascular health checks and behaviour change strategies with the community pharmacy vaccination service has the potential to improve population health outcomes. This scoping review aims to identify potential pharmacist-led cardiovascular-related services suitable for such integration, and to explore the acceptability and feasibility of pharmacy-led services among both service users and providers.

MEDLINE, EMBASE, CINAHL and Web of Science were systematically searched for UK-based empirical studies published between January 2013 and December 2024.

Primary studies reporting on pharmacist-led cardiovascular-related interventions (eg, blood pressure monitoring, cholesterol screening, smoking cessation) delivered to adults (≥18 years) in community pharmacy settings and reporting on clinical outcomes, feasibility or acceptability were included.

Data were extracted using a standardised form on Excel and synthesised narratively. Key domains of interest included intervention characteristics, facilitators, barriers, perceived outcomes, delivery mode and intervention content including behavioural change strategies or components to support implementation.

Of 8322 records screened, 53 studies met the inclusion criteria. Cardiovascular-related interventions were broadly feasible and acceptable to both patients and pharmacy staff. High patient satisfaction was attributed to the accessibility and convenience of pharmacy locations, as well as the ability of pharmacy staff to establish rapport during interactions. Facilitators of service delivery included private consultation spaces, structured training and access to digital screening tools (eg, devices for atrial fibrillation detection). Barriers included workload constraints and limited public awareness of pharmacy services. Five studies described successful integration of lifestyle interventions within pharmacy-based settings, but the long-term clinical outcomes produced by the intervention were rarely reported. Patients valued the convenience and trusted relationships with pharmacists, though concerns about privacy were raised. Pharmacists reported the need for clearer clinical protocols, and multidisciplinary support and training to improve their confidence in delivering health checks as part of their routine work.

Community pharmacies offer an optimal setting for integrating cardiovascular-related screening interventions with the vaccination service delivered within community pharmacy. Successful implementation will require attention to the identified facilitators including the quality of staff training, competing priorities and optimisation and utilisation of pharmacy space. Future research should prioritise definitive controlled trials and cost-effectiveness analyses to assess long-term health outcomes. Policy action is also needed to support service integration and expand pharmacists’ public health roles within the wider National Health Service.

While almost half of older adults admitted to hospital are prescribed potentially inappropriate medicines, less than 1% have a medicine proactively deprescribed during admission in the UK. The CompreHensive geriAtRician-led MEdication Review (CHARMER) intervention is designed to address geriatricians’ and pharmacists’ barriers and enablers to deprescribing. The CHARMER definitive trial will evaluate effectiveness, cost-effectiveness and safety.

A stepped-wedge cluster randomised controlled trial will be conducted in 20 hospitals in England, with four hospitals in reserve. All hospitals will collect baseline data. Every 3 months, five hospitals will be randomised to receive the intervention. The intervention, implemented by a local project manager, comprises a hospital action plan to set deprescribing as an organisational goal; workshops for pharmacists and geriatricians to change beliefs about deprescribing; weekly briefings between geriatricians and pharmacists to discuss opportunities for deprescribing; benchmarking reports to compare deprescribing performance across participating hospitals. With an average of 200 patients admitted and discharged during each step, the study will have 89.5% power at 5% significance level and intra-class correlation coefficient of 0.05 to detect a 3% difference in 90-day re-admission rate from 16.7% versus 13.7%. Anonymised routinely collected data, including readmissions, will be obtained for all patients admitted during the study period. Enhanced data collection periods of 1 month during control and intervention periods will be used to recruit patients and data for secondary outcomes and process evaluation.

A stepped-wedge design enabled a smaller number of hospitals and patients to be included than a traditional cluster-randomised design. The complexity of intervention implementation necessitated a project manager in addition to the principal investigator responsible for trial conduct. Using routinely collected data for the primary outcome measure should ensure that the trial has sufficient power on completion. Planned enhanced data collection for short periods of time improves trial efficiency.

ISRCTN13248281.

To identify barriers and facilitators to implementing an electronic shared decision-making tool for managing anticoagulant-related drug-drug interactions that affect bleeding risk in routine clinical care.

Preimplementation qualitative study using semistructured interviews.

Three academic medical centres in the southeastern and western USA. Interviews were conducted between 27 March and 25 September 2024.

36 participants, including 19 clinicians involved in prescribing or managing anticoagulants and seventeen patients prescribed anticoagulants, were recruited using purposive and convenience sampling.

Participants identified multiple barriers and facilitators to tool implementation. Common barriers included limited visit time, challenges integrating the tool into existing workflows, role and scope-of-practice constraints, and variation in patient digital literacy. Facilitators included clear visualisation of bleeding risk, access to supporting evidence, familiar interface design and perceived potential to support patient engagement and shared decision-making. Several determinants functioned as both barriers and facilitators, depending on clinical context and user role.

This preimplementation qualitative study identified context-specific determinants that influence the adoption of an electronic shared decision-making tool for anticoagulant-related drug–drug interactions. Findings highlight the importance of early attention to workflow integration, role alignment and usability to support uptake in routine care. Addressing these factors during design and implementation may inform strategies to support adoption and future evaluation in real-world clinical settings.

To identify and prioritise research uncertainties regarding the assessment, management and rehabilitation of patients with problematic hip replacements through a national Priority Setting Partnership (PSP).

A national PSP using the James Lind Alliance (JLA) methodology.

UK.

Patients, carers and healthcare professionals (HCPs) involved in the care of patients with problematic hip replacements.

A steering group was established. The James Lind Alliance methodology was followed throughout. A nationwide survey was conducted to collect unanswered questions. These were refined, prioritised through an interim survey and ranked at a final consensus workshop.

The initial survey yielded 201 questions, refined to 32. The interim survey had 191 respondents, leading to 19 questions at the final workshop. The top 10 research priorities were agreed on.

This PSP identified key research priorities for problematic hip replacements, focusing on diagnosis, pain management, perioperative optimisation and infection. These priorities can inform researchers and funders to improve outcomes for affected patients.

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

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

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

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

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

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

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

A significant proportion of infants born at ≤29+6 weeks’ gestation develop lung disease during the neonatal period, thus putting them at risk of developing prematurity-associated lung disease in childhood and adulthood. After discharge from the neonatal unit, pre-existing lung disease in preterm-born infants is exacerbated by (often frequent) respiratory viral infections requiring greater health utilisation, including hospital admissions, than their term-born equivalents. Opportunities to prevent viral infections in infancy are largely limited to anti-respiratory syncytial virus (RSV) antibody prophylaxis and recently maternal RSV immunisation, but in term-born infants, trained immunity-based vaccines such as Bactek (MV130, Inmunotek, Spain) are increasingly used. Bactek provides a promising therapeutic avenue for preterm-born infants to target postdischarge respiratory viral infection in this vulnerable group of infants. The BALLOON study aims to assess this treatment in a very/extremely preterm-born population and determine if treatment with the trained immunity-based vaccine Bactek decreases the risk of unscheduled visits to healthcare professionals for lower respiratory tract infections, when compared with placebo. Included infants are born at ≤29+6 weeks’ gestation and treated daily from term-equivalent (37–43 weeks’ postmenstrual age, PMA) or from discharge, if earlier, up to 1 year of corrected age.

542 infants are being recruited prior to discharge by neonatal units in the UK. They are being randomised to receive Bactek or placebo, once daily dose of 2 sprays (each 0.1 mL) of IMP (300 Formazin Turbidity Units), from 37 to 43 weeks’ PMA or discharge if earlier up to 1 year of corrected age. The primary objective is to assess if sublingual Bactek spray decreases the risk of health professional diagnosed lower respiratory tract infections (LRTIs) (unscheduled visits to general practitioners, accident and emergency departments and hospital admissions) between enrolment and 1 year of corrected age. Secondary outcomes include the number of parent-reported, health professional-confirmed unscheduled visits for LRTIs, the time to first parent-reported, health professional-confirmed unscheduled visit for LRTI, parent-reported wheeze episodes (identification aided by WheezeScan (Omron, Japan)), parent-reported use of respiratory medications, growth (weight, length and head circumference), parent(s)/guardian(s) reported time missed from work and/or nursery time missed for the infant and volume of adverse reactions. Viruses associated with LRTIs will also be identified.

Ethics permission has been granted by the Wales Research Ethics Committee 3 (Ref 24/WA/0181), and regulatory permission by the Medicines and Healthcare Products Regulatory Agency (CTA reference 21323/0063/001-0004). The study is registered on ISRCTN (ISRCTN14019493). Findings will be disseminated via national and international peer-reviewed journals, and conferences. Oversight of the study is being provided by an Independent Data Monitoring Committee and an independent Trial Steering Committee (TSC). The Trial Management Group (TMG) meets every month.

ISRCTN14019493.