Rates of mental health difficulties among girls and young women in the UK have risen sharply, and disproportionately so for those from marginalised groups. My Story and Me is a new digital public mental health intervention that uses storytelling to reduce stigma, increase awareness and support early help-seeking among girls and young women aged 14–18. The feasibility study aims to determine the acceptability of the intervention and future full trial, including assessing optimal settings and meaningful changes in the primary outcome measure (anxiety and depression).

This is an 18-month mixed-methods, uncontrolled feasibility study conducted in secondary schools, further education colleges and community organisations across the UK. We will recruit 120–180 participants. Quantitative data will be collected at baseline and 7-month follow-up. The primary outcomes are anxiety and depression, and secondary outcomes are social support, mentalising, stigma, quality of life, loneliness, empowerment, intervention acceptability, resource use and randomisation acceptability. Platform-level engagement data will assess adherence and fidelity. Qualitative interviews with young women and staff will explore acceptability, feasibility, mechanisms of change and views on trial procedures, including randomisation in a future full trial. Analysis will be descriptive and exploratory, including comparisons across settings and priority groups (LGBTQIA+, neurodivergent and those experiencing digital poverty). A framework and reflexive thematic analysis approach will be used for qualitative data. Prespecified progression criteria will inform decisions about advancing to a full cluster randomised trial.

The University College London Research Ethics Committee (0692) has approved the My Story and Me protocol. Interested participants will be required to complete an expression of interest and consent form to take part in the study, and young people under 16 years old will be required to obtain parent/carer informed consent. Results will be disseminated through peer-reviewed publications, lived experience summaries, a policy briefing and academic conference presentations.

ISRCTN12191423.

The Circle of Security-Parenting (COS-P) group intervention has demonstrated efficacy in reducing maternal perinatal mental health difficulty (PMHD) symptoms in some contexts. The Circle of Security Intervention (COSI) study, a multisite, individually randomised, single-blind, parallel-arm controlled trial, was conducted in England to assess the clinical effectiveness of COS-P in reducing perinatal psychopathology, parenting and infant development, as well as its acceptability among the National Health Service (NHS) participants and staff. The main aim of this work is to estimate the cost-utility of COS-P plus treatment as usual (TAU) relative to TAU among mothers and birthing parents receiving NHS perinatal mental health services (PMHS) in England.

A within-trial economic evaluation was performed comparing COS-P plus TAU with TAU alone, using data from the COSI trial, which employed a 2:1 randomisation ratio. Analyses were conducted from both NHS and personal social services (PSS) and societal perspectives. A 12-month time horizon was used, consistent with the final trial follow-up.

Secondary care NHS perinatal health services across multiple centres in England.

A total of 371 mothers and birthing parents with PMHD were randomised and had complete economic outcome data; 248 received COS-P plus TAU and 123 received TAU alone. Participants were eligible if they were receiving NHS PMHS; exclusion criteria were defined in the trial protocol.

Participants in the intervention arm received the COS-P group programme in addition to TAU. The control group received TAU alone.

The primary economic outcome was quality-adjusted life years (QALYs) over 12 months, derived from the 5-level EuroQol five-dimensional (EQ-5D-5L) questionnaire - responses. Costs were estimated from NHS and PSS as well as societal perspectives, including healthcare utilisation and productivity losses due to work absence.

Compared with TAU, COS-P was associated with higher costs from both NHS and PSS (£180.58; 95% CI –£1075 to £1436) and societal (£72.94; 95% CI –£1473 to £1619) perspectives. COS-P was marginally less effective in terms of QALYs (–0.01; 95% CI –0.06 to 0.05). Probabilistic sensitivity analyses indicated substantial uncertainty around cost and effectiveness estimates.

On average, COS-P was associated with higher costs and did not demonstrate improvements in health-related quality of life compared with TAU alone. Given the uncertainty surrounding the estimates, further research is warranted to explore potential longer term economic and clinical impacts of COS-P in perinatal mental health settings.

SRCTN18308962.

Three-quarters of mental health problems start before the age of 25. However, young people are the least likely to receive mental healthcare. Some young people (such as those from ethnic minorities) are even less likely to receive mental healthcare than others. Long-term impacts of mental health problems include poorer physical health, relationships, education and employment. We aim to elicit the views, experiences and needs of diverse young people (aged 16–24 years), to better understand (1) their experiences of under-representation, mental health and coping, (2) mechanisms that shape mental health trajectories and (3) how online arts and culture might be made engaging and useful for young people’s mental health. We also aim to do this with autistic young people.

Narrative inquiry will be employed as a tool for gathering young people’s perspectives for an iterative analysis. The narrative method proposes that critical insights and knowledge are distributed across social systems and can be discovered in personal stories and that knowledge can be relayed, stored and retrieved through these stories. Data will be transcribed and explored using a combination of thematic and intersectional analysis. Young people will be core members of the research team, shape the research and be involved in the coding of data and interpretation of the findings.

This study (IRAS project ID 340259) has received ethical approval from the HRA and Health and Care Research Wales (REC reference 24/SC/0083). The outputs will identify touch points and refine the logic model of how online arts and culture might support the mental health of those from under-represented backgrounds. We will share knowledge with young people, policy makers, health professionals, carers, teachers, social workers and people who work in arts and culture. We will produce research papers, blogs, newsletters, webinars, videos and podcasts.

To describe the association between place of residence in Alberta, Canada, and cardiovascular event risk among adults newly treated with metformin for type 2 diabetes.

Retrospective cohort study.

Administrative data from Alberta, Canada between 2008 and 2023.

Adult new metformin users, categorised by residence (rural, urban, metropolitan) from postal codes 1 year before metformin.

Cause-specific hazard models were constructed for the primary composite outcome (cardiovascular mortality, hospitalisation for an acute coronary syndrome or stroke) and each of the secondary outcomes (components of the primary outcome and all-cause mortality). Models were adjusted for baseline demographics, healthcare utilisation and diabetes complications.

A total of 236 005 adult new metformin users were identified and distributed across the rural-urban continuum (66% metropolitan, 10% urban, 24% rural). Mean age was 55 years, 55% were men, and mean follow-up time was 5.7 years. There were 19 059 primary composite outcome events, and rural residents were more likely to experience the outcome, adjusted HR (aHR): 1.09 (95% CI 1.06 to 1.13), compared with metropolitan. A significant interaction between residence and cardiovascular event history was identified. When stratified, risk of the primary outcome among those without cardiovascular history and living in a rural area was aHR: 1.16 (95% CI 1.11 to 1.20). Among rural residents with cardiovascular history, the risk was aHR: 0.84 (95% CI 0.78 to 0.91).

Quantifying the association between residence and risk of cardiovascular events may focus the allocation of healthcare resources. Development of targeted intervention programmes should focus on primary prevention in rural areas and secondary prevention in metropolitan areas.

Chronic limb-threatening ischaemia (CLTI) represents a severe and debilitating condition characterised by inadequate blood supply to the extremities, leading to acute and persistent pain, ulceration and a heightened risk of limb loss. Patients with CLTI often experience chronic pain that significantly impairs their quality of life. The pain experienced by patients with CLTI can be complex and challenging to manage, requiring a refined approach to balance analgesic efficacy with potential adverse pharmacological effects and pre-existing, competing comorbidities. This systematic review protocol aims to explore, critically assess and compare the effectiveness and safety of different pharmacological and locoregional analgesic approaches for managing pain occurring secondary to CLTI.

The methods will be performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Five electronic databases will be searched. At least two reviewers will perform study screening, data extraction and quality assessments. Any disagreements will be arbitrated by an additional independent reviewer. Randomised studies, observational cohort studies and case series consisting of four or more patients will be included. Grey literature will be excluded. The primary outcome will be the effectiveness of analgesia. Secondary outcomes will include adverse effects of analgesia and functional outcomes. Where the data allow, appropriate quantitative synthesis methods will be pursued.

This systematic review will not involve primary data collection; thus, no ethical approval is required. The results will be disseminated in a peer-reviewed publication and presented at conferences.

CRD42024561800