The global prevalence of type 2 diabetes (T2D) is rising and disproportionately affects South Asian adults, including those in the United Kingdom. South Asians develop T2D at a higher rate and at a younger age than their white British counterparts, at a lower body mass index. Active efforts to reduce adiposity can improve glycaemic control and in some cases achieve T2D remission. However, a substantial proportion of lean mass is lost while achieving weight loss, which may have physiological and metabolic consequences, affecting long-term health outcomes and quality of life for people living with T2D and obesity. We are examining the impact of a combined low energy diet and supervised exercise intervention versus a low energy diet alone for the preservation of lean mass in an understudied South Asian population living with T2D and excess adiposity.

This prospective, randomised, two-arm parallel-group, open-label, blinded-endpoint trial is being conducted in Leicester, UK. 36 South Asian adults aged 40–65 years within 10 years of T2D diagnosis and not on insulin therapy will be enrolled. Both intervention arms will receive an 800–900 kcal/day low energy diet for 12 weeks. Those randomised to the exercise group will additionally receive a mixture of supervised and home-based resistance and aerobic exercise training three times per week. The primary outcome is the difference in the change of lean mass between groups measured using dual-energy X-ray absorptiometry at baseline and 12 weeks and will be analysed using linear regression modelling.

The trial was approved by the NHS research ethics service (23/WM/0201). All participants will provide informed consent prior to enrolment, and the study will be conducted in accordance with the Declaration of Helsinki. Findings will be shared widely (publications, presentations, press releases, social media platforms) and will inform an effectiveness trial.

ISRCTN11175684.

Hand osteoarthritis (OA) is a prevalent and debilitating joint disorder that impairs daily functioning and quality of life. Current treatments are often inadequate in managing the symptoms and progression of the disease. The cytokine interleukin (IL)-17 has been implicated in the inflammatory processes associated with OA, making it a potential target for therapeutic intervention. This trial aims to evaluate the efficacy of vunakizumab, an IL-17A inhibitor, in reducing pain and improving functional outcomes in patients with erosive hand OA.

This multicentre, randomised, placebo-controlled, double-blind trial will enrol 150 participants aged 30–80 years with symptomatic erosive hand OA. Participants will be randomised in a 1:1 ratio to receive either vunakizumab 120 mg or placebo subcutaneously every 4 weeks for 24 weeks, with a loading dose injection period during the first 4 weeks. The primary outcome is the change in hand pain assessed by the Visual Analogue Scale at 28 weeks. Secondary outcomes include changes in physical function measured by the Functional Index for Hand Osteoarthritis, the Quick Disabilities of the Arm, Shoulder and Hand questionnaire and the Health Assessment Questionnaire, as well as changes in grip strength and radiographic and MRI evaluations of the hands.

Written informed consent will be obtained from all participants. The study was approved by the Ethics Committee of Shanghai Sixth People’s Hospital (2024–217) and will adhere to the Declaration of Helsinki. Research results will be published in peer-reviewed journals.

ChiCTR2500101031; https://www.chictr.org.cn/showproj.html?proj=264789.

Self-injurious thoughts and behaviours (SITBs) represent a critical public and mental health challenge. Adolescents are disproportionately at risk for engaging in SITBs. Intervening early and addressing pathogenic and proximal risk/vulnerability factors is of critical importance for this vulnerable population. Digital Single-Session Interventions (D-SSIs) offer a promising solution to unmet need for accessible, scalable and engaging care. This pilot study aims to evaluate the acceptability and feasibility of the interventions and clinical trial protocol for Programme LIFT (Little Interventions for Teens), a newly developed suite of D-SSIs targeting emotional regulation, self-criticism, rumination and hopelessness as key risk processes involved in the maintenance of SITBs.

We aim to recruit 216 Australian adolescents aged 15–19 years who have experienced SITBs in the past 2 months into an online, 2x2 factorial randomised controlled trial to pilot the acceptability and feasibility of the intervention protocol (D-SSI+28 days of skill practice) and trial procedures, and establish study retention. Random allocation procedures will be used to test factors that may affect adherence to the intervention protocol (primary feasibility outcome), by testing the effect of: (1) intervention assignment method (free choice vs clinician prescribed), and (2) a postintervention brief, supportive phone check-in at 7 days postcompletion of the D-SSI (phone call vs no call). Feasibility and acceptability will be assessed using online surveys at postintervention (T1) and 30 days follow-up (T3), along daily brief assessments of skill practice between T1 and T2 (T2). The trial and its protocol were developed and reported in accordance with the Standard Protocol Items for Interventional Trials checklist.

This study is approved by the University of New South Wales Human Research Ethics Committee (HREC#9032). Results will be published in an open access peer-reviewed journal, and key study findings will be shared with participants and stakeholders within 3 months after completion of the study.

ACTRN12625000963426.

The REgulate your SItting Time (RESIT) is a tailored intervention targeting reductions and breaks in sitting in adults with type 2 diabetes mellitus (T2DM). A feasibility trial of RESIT had been conducted and the purpose of this paper is to report findings from the process evaluation.

A mixed-methods process evaluation within a randomised controlled feasibility trial.

The study was conducted remotely in the community.

Ambulatory individuals with T2DM aged 18–85 years.

A tailored intervention comprising an online education session, regular health coaching and technology for self-monitoring behaviour and prompting breaks in sitting.

Questionnaires (intervention participants n=22 at both 3 and 6 months; control participants n=21 at 3 months, n=29 at 6 months) and interviews (n=30, with n=13 intervention participants, n=12 control participants, n=5 health coaches) to assess perceptions of the intervention components, strategies and barriers for sitting less, the role of the study evaluation measures, and reasons for taking part.

The trial operated a largely successful online education element for those in the intervention group (82% completion; ≥76% engagement in individual educational elements). There was good use of self-monitoring and prompt technology (apps and wearables) with 73% of participants reporting using these at 6 months. Health coaching had high engagement and was perceived as enjoyable and useful. Data revealed strategies used for behaviour change (eg, active functional tasks) alongside barriers to change (eg, restrictions at work). There were also potential behavioural influences from the study evaluation measures (eg, activity measures increasing awareness and execution of behaviours) for both intervention and control participants.

A comprehensive process evaluation identified successful intervention elements (ie, online education, health coaching, wearables and smartphone apps) alongside strategies and barriers to behaviour change. These findings can inform future sedentary behaviour interventions for adults with T2DM and a definitive randomised controlled trial evaluating RESIT.

ISRCTN14832389.

Recent research indicates that around 8% of older people living in prison have signs or symptoms of dementia or mild cognitive impairment (MCI), yet the care they receive is not equivalent to care in the community and this means their needs may not be met. We co-developed an intervention specifically for older people living in prison with dementia/MCI (Dementia and Mild Cognitive Impairment in prison care pathway and training package–DECISION). To date, this has not been implemented or evaluated. This paper presents our protocol for a study to assess the feasibility and acceptability of DECISION.

This is a non-randomised, realist-informed mixed-methods feasibility study with integrated process evaluation, which will take place in two prisons in England. The intervention was codeveloped with experts with lived experience. Participants will include older people living in prison, staff working in prison and peer supporters. We will assess the feasibility and acceptability of the intervention (eg, numbers eligible; rates of recruitment and retention), and the evaluation design (eg, completion rates of standardised outcome measures). Methods will include semistructured, realist-informed interviews; an audit to assess implementation fidelity; focused ethnography; training questionnaires; and collection of resource use data. We will refine the DECISION programme theory using realist-informed methods to examine and refine how contexts and mechanisms interact to produce the intervention’s outcomes.

This study received a favourable ethical opinion from the Wales REC 3 Research Ethics Committee in January 2025 (reference number 24/WA/0323). HMPPS National Research Committee approval was also granted in January 2025 (reference number 2024-1451). Findings will be disseminated through a range of avenues, including stakeholder engagement events, open-access papers, conference presentations, evidence briefings for commissioners, providers and practitioners, and newsletters for service users.

We investigated symptoms reported before and after heart failure (HF) diagnosis and their associations with 3-month hospitalisation and mortality.

To examine associations between symptoms recorded in primary care and short-term hospitalisation and mortality in HF patients.

Landmark analysis using Royston-Parmar survival models at baseline (diagnosis), 6 and 12 months post-diagnosis.

Primary care database (Clinical Practice Research Datalink) linked to hospital and mortality data (1998–2020).

Adults (>40 years) with a first HF diagnosis.

Shortness of breath, ankle swelling, oedema, fatigue, chest pain, depression and anxiety in the 3 months before diagnosis and at 6 and 12 months.

3-month all-cause hospitalisation and mortality; secondary outcomes included HF and non-cardiovascular hospitalisation.

Among 86 882 HF patients (62 742 and 54 555 surviving to 6 and 12 months, respectively), the magnitude of symptom risk varied by timepoint. Specifically, the symptoms with the strongest associations with adverse outcomes were: depression for all-cause hospitalisation at diagnosis (HR: 1.26; 95% CI 1.15 to 1.39) and 6 months (1.46; 1.25 to 1.70); ankle swelling for mortality (1.49; 1.14 to 1.94) at 6 months and SOB for HF hospitalisation (1.18; 1.12 to 1.26) at diagnosis and 12 months (1.99; 1.68 to 2.35).

Symptoms persisted and were more prominent at 6 and 12 months post-diagnosis than at diagnosis.

Mental health and substance use problems among people released from prison contribute substantially to premature mortality and emergency services demand. Understanding of mental health and substance use-related health service contacts prior to these severe and costly outcomes is limited. We assessed mental health and substance use-related contact with multiple services, comparing rates of contact among people released from prison to a matched general population sample who had not recently been in prison.

To compare rates of health service contacts for mental health and substance use between people released from prison and a matched general population sample.

We conducted a retrospective cohort study using linked administrative data with nationwide coverage. The cohort contained all people released from any Scottish prison in 2015 (exposed group), and a random general population sample matched (ratio 1:5) on sex, age, postcode and deprivation indices, who had no imprisonment in the 5 years prior (unexposed group). We linked individual-level administrative healthcare (prescriptions, outpatient, inpatient, emergency/unscheduled care: 2010–2020), prison (admissions, releases: 2010–2020) and deaths records (2015–2020). We estimated adjusted incidence rate ratios (aIRRs) with 95% CIs using fixed-effects Poisson regression with cluster-robust standard errors, controlling for time-in-community, pre-index mental health and substance use-related health service contacts, and comorbidities. We stratified models by mental health (MH), substance use (SU) and dual diagnosis (attributable to both MH and SU).

Scotland.

We linked records for 8313 people released from prison, and 41 213 matched individuals. Mental health and substance use-related contact rates were significantly higher for people released from prison across all services, and particularly for emergency and unscheduled care. aIRRs for ambulance contacts were MH=7.75 (95% CI 5.76 to 10.42), SU=7.58 (95% CI 5.71 to 10.08), dual diagnosis=8.28 (95% CI 6.50 to 10.55); and accident and emergency department contacts were MH=4.88 (95% CI 3.78 to 6.29) and SU=7.98 (95% CI 5.71 to 11.17). aIRRs for community prescriptions were MH=1.80 (95% CI 1.67 to 1.94), SU=5.95 (95% CI 4.83 to 7.32), dual diagnosis=5.33 (95% CI 3.70 to 7.68); drug and alcohol services were 7.13 (95% CI 6.00 to 8.48); and outpatient attendances were 2.61 (95% CI 2.17 to 3.16). aIRRs for 24-hour unscheduled telephone support were MH=7.63 (95% CI 4.93 to 11.83) and SU=8.29 (95% CI 3.99 to 17.22); and out-of-hours general practice were MH=5.14 (95% CI 3.66 to 7.22), SU=5.89 (95% CI 3.11 to 11.14) and dual diagnosis=8.85 (95% CI 2.94 to 26.63). aIRRs for general/acute hospital admissions and day cases were MH=2.97 (95% CI 1.43 to 6.16), SU=7.85 (95% CI 4.42 to 13.91), dual diagnosis=13.11 (95% CI 7.95 to 21.61); and for psychiatric admissions were MH=3.62 (95% CI 2.39 to 5.49), SU=10.74 (95% CI 6.12 to 18.84) and dual diagnosis=7.74 (95% CI 4.30 to 13.94).

Improved post-release mental health and substance use care is vital for individual and public health. Despite elevated rates of contact with community mental health and substance use services, people released from prison have disproportionately high rates of contact with emergency and unscheduled care services. This suggests that early support is either inadequate or not accessed by those in greatest need.

Policymakers and service providers should consider investment in tailored transitional and post-release intervention at individual and population level, to improve health and thus prevent later high-cost service use and avoidable mortality. Our results also suggest high-quality care must be available and accessible beyond the immediate post-release period to permit sustained engagement or engagement at a later date.

Although breastfeeding is associated with lower postnatal depression and anxiety, limited research exists regarding long-term maternal mental health outcomes. This study examined the association between breastfeeding and depression and anxiety in women of later reproductive age (mid 30s to menopause).

This was a 10-year prospective longitudinal cohort study. Self-reported questionnaires were used to collect lifetime breastfeeding behaviour at 10 years, and health history including depression, anxiety and medication use was collected at each study timepoint.

A tertiary level maternity hospital in Dublin, Ireland.

168 parous women from the ROLO Longitudinal Cohort with lifetime breastfeeding behaviour and health history data available at 10 years were included (22% of total cohort). Women currently pregnant or breastfeeding at 10-year follow-up were excluded.

Mean (SD) age at study end was 42.4 (3.8) years. 72.6% (n=122) of women reported ever breastfeeding. Median lifetime exclusive breastfeeding was 5.5 weeks (IQR 35.8, range 0–190). 37.5% of women (n=63) breastfed for ≥12 months over their lifetime. 13.1% (n=22) reported depression or anxiety at 10 years, and 20.8% (n=35) reported depression or anxiety over the whole study period. Ever breastfeeding was associated with less depression and anxiety at 10 years (OR 0.34, 95% CI 0.12 to 0.94, p=0.04). Ever breastfeeding, longer exclusive breastfeeding and lifetime breastfeeding ≥12 months were associated with lower depression and anxiety over the whole study period (ever breastfeeding OR 0.4, p=0.03; exclusive breastfeeding OR 0.98/week, p=0.03; lifetime breastfeeding ≥12 months OR 0.38, p=0.04).

There may be a protective association between breastfeeding and self-reported depression and anxiety. Further studies are required to confirm the findings.

ISRCTN54392969.

To examine the barriers and facilitators of anorexia nervosa (AN) recovery in adults with autism.

Qualitative study using semi-structured interviews with autistic adults who identified as being in recovery or having recovered from AN.

Participants were recruited via advertisements on social media and an eating disorder (ED) forum. Online Zoom interviews with 12 participants were conducted from October to November 2023.

Overall, 12 autistic adults who identified as being in recovery or recovered from AN were included (11 women and 1 man; aged between 18–50 years).

Four key themes were identified: ‘Sensory Experiences’, ‘Recovery in progress’, ‘Changing to healthy mindsets’ and ‘Engaging with treatment’. Results indicated that recovery for participants did not follow a linear path, with the role of autistic traits, such as sensory sensitivities, interoception and the internal voice, making recovery challenging.

This study provides insight into the challenges and motivations experienced during the recovery process. Findings highlight the need for further research to improve guidelines and autism awareness in ED services.

Venous thromboembolism (VTE) is a common complication of traumatic brain injury (TBI) and is associated with increased morbidity and mortality. Low molecular weight heparin (LMWH) is recommended for prophylaxis against VTE after trauma but may increase the risk of progression of intracranial bleeding. Limited evidence exists to guide clinicians regarding the optimal timing of VTE prophylaxis in patients with acute TBI. This randomised controlled trial (RCT) will directly compare the safety and effectiveness of early versus delayed initiation of LMWH in patients with moderate to severe TBI.

The study design is a Bayesian adaptive RCT comparing early (within three calendar days of injury) versus delayed (after study Day 7) VTE prophylaxis with the LMWH, dalteparin. All patients receive sequential compression devices until study Day 8. The co-primary effectiveness outcome is the development of clinically important VTE at study Day 8. The co-primary safety outcome is the development of clinically important intracranial bleeding at study Day 8. Secondary outcomes are mortality and functional outcomes (Glasgow Outcome Scale Extended and EQ-5D) measured at study Days 30 and 180; clinically diagnosed VTE to Day 30 and progression of intracranial bleeding to Day 8.

This study has been approved through Clinical Trials Ontario’s streamlined ethics review process (board of record, Sunnybrook Health Sciences Centre) and all participating centres. It is conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines and Health Canada regulatory requirements. We anticipate that the trial will achieve wide dissemination through publication in a peer-reviewed medical journal and presentation at international conferences targeting the fields of critical care, trauma and neurosurgery. The results of this trial will help guide clinicians aiming to balance the risks and benefits of early anticoagulant prophylaxis after TBI and will inform guideline development.

NCT03559114.

To develop prediction models for short-term outcomes following a first acute myocardial infarction (AMI) event (index) or for past AMI events (prevalent) in a national primary care cohort.

Retrospective cohort study using logistic regression models to estimate 1-year and 5-year risks of all-cause mortality and composite cardiovascular outcomes.

Primary care practices in England contributing data to the Clinical Practice Research Datalink (CPRD) Aurum and CPRD GOLD databases between 2006 and 2019.

Patients with an incident (index) or prevalent AMI event. Models were trained on a random 80% sample of CPRD Aurum (n=1018 practices), internally validated on the remaining 20% (n=255) and externally validated using CPRD GOLD (n=248).

Discrimination assessed using sensitivity, specificity and area under the receiver operating characteristic curve (AUC). Calibration assessed using calibration plots.

In the index (prevalent) cohorts, 94 241 (64 789) patients were included in the training and internal validation sets, and 16 832 (7479) in the external validation set. For the index cohort, AUCs for 1-year [5-year] all-cause mortality were 0.802 (95% CI 0.793 to 0.812) [0.847 (0.841 to 0.853)] internally and 0.800 (0.790 to 0.810) [0.841 (0.835 to 0.847)] externally. For the primary composite outcome (stroke, heart failure and all-cause death), AUCs were 0.763 (0.756 to 0.771) [0.824 (0.818 to 0.830)] internally and 0.748 (0.739 to 0.756) [0.808 (0.801 to 0.815)] externally. Discrimination was higher in the prevalent cohort, particularly for 1-year mortality (AUC: 0.896, 95% CI 0.887 to 0.904). Models excluding treatment variables showed slightly lower but comparable performance. Calibration was acceptable across models.

These models can support clinicians in identifying patients at increased risk of short-term adverse outcomes following AMI, whether newly diagnosed or with a prior history. This can inform monitoring strategies and secondary prevention and guide patient counselling on modifiable risk factors.

Racialised older adults living with dementia face various challenges and barriers in receiving culturally sensitive care in hospital settings. Stigma, discrimination and healthcare provider bias toward racialised older adults living with dementia infringe on their right to access quality care services in acute hospital settings and can negatively affect their quality of life. Despite the growing need to integrate culturally sensitive dementia care into acute hospital care, little research has been done in this area. Therefore, the aim of this scoping review is to summarise and map what is known about the hospitalisation experience of racialised older adults with dementia in receiving care and identify research gaps.

We will use Arksey and O’Malley’s framework and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews checklist to conduct and write the review. The search strategy will use keywords and index terms across selected databases: Google Scholar, PubMed, Scopus, Medline, PsycINFO and Cumulative Index for Nursing and Allied Health Literature, and hand-searching the reference lists from chosen literature. Grey literature will be searched using Google and the Alzheimer Society websites to find further evidence and literature. Two researchers will screen the titles and abstracts independently by referring to the inclusion criteria. Data from the extracted studies will be reported in tabular and narrative form that answer the scoping review’s questions. Research gaps and recommendations for future research will be identified and summarised. The review’s results will be shared with stakeholders, policymakers, healthcare professionals and community organisations working with the racialised community and dementia care.

This scoping review does not require ethics approval because it collects data from publicly available resources. The results will be disseminated through peer-reviewed scientific journals, professional conferences and with community organisations and healthcare providers.

This review is registered in the Open Science Framework registration link: osf.io/7rfje

Multimorbidity or the presence of two or more long-term conditions is now common in people undergoing surgery. However, current care pathways often miss these healthcare encounters to support long-term health promotion. Therefore, there is a need for practical, scalable approaches that can be integrated into routine surgical care, for which limited solutions exist at present. We have co-designed a structured preoperative checklist to help identify and manage long-term conditions in patients listed for elective surgery. This study aims to evaluate the feasibility and acceptability of this preoperative checklist in patients undergoing elective surgery.

This is a mixed-methods feasibility study in one National Health Service trust in the UK. We will recruit up to 50 adults scheduled for elective surgery and use the checklist during initial surgical clinic appointments. Quantitative data will include recruitment and retention rates, completion of the checklist and baseline clinical characteristics, analysed using descriptive statistics. Qualitative data will be collected through semistructured interviews with up to 16 patients and clinicians. These interviews will be analysed thematically, guided by the Consolidated Framework for Implementation Research. Triangulation of quantitative and qualitative data will allow us to explore fidelity, acceptability, barriers and facilitators to implementation and refine the intervention ahead of a future pilot cluster randomised trial.

This study has received approval from the Yorkshire & The Humber - Sheffield Research Ethics Committee (approval number: 25/YH/0045). All participants will give written informed consent. Results will be published in peer-reviewed journals and shared with participants, the public and policy stakeholders.

The vast majority of healthcare research in the UK is investigator-led. While national progress in patient and public involvement (PPI) increasingly mandates patient consultation, research questions and outcomes still frequently misalign with patient priorities. This is particularly important in rare disease research, as more than 95% of 11 000 conditions have no effective or curative treatment, and around 20% are not clinically defined, making them difficult to diagnose and manage. The unmet physical, mental and emotional needs of people living with rare diseases are immense. Extensive guidance and toolkits exist to support investigators with PPI, but none target patient communities attempting to promote their own priorities, initiate or co-lead research.

This communication article introduces the newly established patient-led Rare Disease Research Network (RDRN).

Launched in November 2024, the RDRN is an open-access collaborative platform designed to support patient-driven and co-produced research, connecting patient and professional partners with similar research interests. Originally conceived by an ultra-rare patient group, the network was co-produced with the rare disease community, including individuals living with rare conditions, parents, carers and charity advocates, whose lived experience and priorities shaped every aspect of its design. Supported by academic and research networks, its collaborative development ensures RDRN removes barriers to participation while complementing existing initiatives. RDRN is a novel approach to driving new impactful research by aligning investigator priorities with real-world needs and building capacity from patients outward. Rare disease communities bring lived expertise, creativity and motivation. Yet without a structured route to collaborate, their insights are often lost. RDRN offers an inclusive space, fostering new partnerships and supporting upstream collaboration. The approach enables patients to become ‘research ready’ and empowers them to have an active role in generating ideas and delivering research from inception, leading to innovative research and driving meaningful change in patients’ lives. With further development, RDRN could present a lasting, scalable and unified model for co-designed rare disease research. By enabling trust, capacity and shared purpose, it can drive discovery, improve outcomes and build a more resilient and self-sustaining research ecosystem, underpinning key pillars of the 2021 UK Rare Diseases Framework.