Evidence suggests a 38% risk reduction in breast and bowel cancer-specific mortality with higher levels of exercise, however, most of this evidence is observational. More clinical trials are needed to build strong evidence for exercise’s impact on recurrence and survival. This study aims to assess the feasibility, acceptability and potential efficacy of a remote, tailored exercise programme on disease-free survival in patients recently completing curative treatment for early-stage, high-risk lung, breast or bowel cancer.

This UK-based, multicentre randomised controlled basket feasibility trial compares a personalised, remote-delivered exercise programme supported by exercise professionals against usual care. Potential participants are approached if they are: aged 18 or over, diagnosed with high-risk, early-stage breast, bowel or lung cancer, and within 24 weeks of completing primary curative treatments. Participants complete objective measures of physical function (submaximal cardiovascular fitness, endurance, muscle strength and balance), body composition (bioelectrical impedance) and self-reported outcomes (total physical activity, sleep quality, general quality of life (QoL), cancer-related QoL and exercise confidence/motivation). Clinical case note review provides disease-free survival outcomes at 6, 12 and 24 months. The 12-week programme is delivered remotely (via phone, email and/or video conference) with trainer contact tapering off over the subsequent 12 weeks (24 weeks total). Recruitment is ongoing with a 660-participant goal. Descriptive measures (quantitative and qualitative) will be reported for feasibility outcomes: recruitment, adherence, retention rates, data collection quality, adverse events, intervention acceptability and fidelity. A process evaluation is being conducted concurrently and is reported separately. Kaplan-Meier curves will be plotted and median disease-free survival calculated for each arm. To determine intervention impact, a log-rank test (unadjusted) will compare 2-year disease-free survival between groups within and among cancer types. Secondary outcomes (physical function status, general/cancer-specific QoL and determinants of meeting activity guidelines) will be reported at each time point.

Ethical approvals were obtained through Hull York Medical School (ID: 23/SS/0060) and UK NHS Health Research Authority (ID: 327663). Findings will be submitted for publication in high-impact journals, presentation at national and international conferences, press releases where appropriate, and dissemination activities to be decided on with the Patient Advisory Group.

ISRCTN97662203.

Participation in physical activity (PA) is a cornerstone of the secondary prevention of stroke. Given the heterogeneous nature of stroke, PA interventions that are adaptive to individual performance capability and associated co-morbidity levels are recommended. Mobile health (mHealth) has been identified as a potential approach to supporting PA post-stroke. To this end, we used a Sequential Multiple Assignment Randomised Trial design to develop an adaptive, mHealth intervention to improve PA post-stroke – The Adaptive Physical Activity programme in Stroke (TAPAS) (Clinicaltrials.Gov NCT05606770). As the first trial in stroke recovery literature to use this design, there is an opportunity to conduct a process evaluation for this type of adaptive intervention. The aim of this process evaluation is to examine the implementation process, mechanism of change and contextual influences of TAPAS among ambulatory people with stroke in the community.

Guided by the Medical Research Council Framework for process evaluations, qualitative and quantitative methods will be used to examine the (1) implementation process and the content of TAPAS (fidelity adaptation, dose and reach); (2) mechanisms of change (participants’ response to the intervention; mediators; unexpected pathways and consequences) and (3) influence of the context of the intervention. Quantitative data will be presented descriptively, for example, adherence to exercise sessions. Qualitative data will be collected among TAPAS participants and the interventionist using semi-structured one-to-one or focus group interviews. Transcribed interviews will be analysed using reflexive thematic analysis. Key themes and sub-themes will be developed.

Ethical approval has been granted by the Health Service Executive Mid-Western Ethics Committee (REC Ref: 026/2022) (25/03/2024). The findings will be submitted for publication and presented at relevant national and international academic conferences.

Relational continuity of care (RCC) refers to the sustained therapeutic relationship between a patient and a clinician, which fosters trust, enhances communication and facilitates the accumulation of knowledge about the patient. RCC is associated with enhanced patient outcomes, reduced hospital admissions, lower mortality rates, decreased healthcare costs and improved patient experience. Despite these benefits, reorganisations within the NHS and workforce challenges have led to an increased reliance on multidisciplinary and part-time working, resulting in fragmented care and a decline in RCC. Our study aims to explore who needs RCC, under what circumstances, to what extent and why, with the goal of informing optimal implementation strategies.

We will conduct a realist review to develop an evidence-based programme theory explaining the mechanisms underlying RCC, the populations that benefit most, the contextual factors influencing RCC and effective care models. Following Pawson’s five iterative stages, we will: (1) Locate existing theories, (2) Search for relevant evidence, (3) Select appropriate articles, (4) Extract and organise data and (5) Synthesise findings to draw conclusions. A stakeholder advisory group, comprising policymakers, healthcare professionals, public contributors and patients, will be engaged throughout the process. We will adhere to Realist And Meta-narrative Evidence Synthesis: Evolving Standards (RAMESES) for realist reviews to ensure methodological rigor.

Our findings will inform practical, evidence-based recommendations for optimising RCC within general practice. Outputs will include peer-reviewed publications, conference presentations, plain English summaries, social media infographics, a short video and end-of-study events. Collaborations with stakeholders and public involvement will ensure both accessibility and impact. Ethical approval is not required for this review.

To describe the available literature on the epidemiology and factors associated with osteoporosis, falls and fractures in four chronic inflammatory rheumatic diseases (CIRD): rheumatoid arthritis (RA); psoriatic arthritis (PsA); ankylosing spondylitis (AS); and systemic lupus erythematosus (SLE).

Scoping review, using the Joanna Briggs Institute framework.

MEDLINE, Embase and CINAHL from January 2000 to December 2023.

Observational studies reporting on the epidemiology and/or associated factors for osteoporosis, falls and fractures in RA, PsA, AS or SLE.

Two independent reviewers used a standard data extraction form including report methods, definitions, outcomes and associated factors. Results are summarised with descriptive statistics.

288 studies met inclusion criteria, with 170 studies on RA, 19 on PsA, 49 on AS and 60 on SLE. Most studies were cross-sectional, with Europe and Asia having the greatest output. Most papers reported on osteoporosis and fractures as outcomes, with only 27 reporting falls, of which 24 were in RA. Participants’ demographics and disease-related parameters were the most frequently explored potential associated factors.

RA was the most well-studied CIRD with regard to the epidemiology and associated factors for osteoporosis, fractures and falls. Cross-sectional was the most common study design, with a higher proportion of cohort studies in RA. There is a paucity of studies assessing falls in CIRDs other than RA. Future observational research should be conducted with large prospective CIRD cohorts, with falls as an outcome and associated factor for fractures. This may enable better understanding of the risk and consequences of osteoporosis, fractures and falls, which may improve preventive care.

In the UK National Health Service (NHS), most people with cancer are cared for at oncology outpatient services, where there are no standardised procedures for managing pain. As a result, patients with cancer may receive inadequate care for pain. The Cancer Pain-assessment Toolkit for Use in RoutinE oncology outpatient services aims to assess the feasibility of conducting a multicentre cluster-randomised trial of a systematic pain assessment and management programme integrated within routine care at UK NHS oncology outpatient services. This protocol describes an embedded process evaluation that aims to evaluate the acceptability, fidelity and implementation of the intervention and trial procedures.

A combination of methods will be used in the process evaluation. Quantitative data on fidelity and intervention implementation will be collected using case report forms completed at sites, capturing details on training, intervention delivery and adherence. Qualitative data on acceptability and trial experience will be collected through semistructured interviews with intervention recipients (participants), intervention deliverers (healthcare professionals), research nurses and intervention champions. Researcher fieldnotes will also document trial acceptability throughout the trial. Quantitative data will be summarised descriptively. Qualitative data will be analysed using thematic analysis, guided by the framework of acceptability.

The trial received ethical approval from South Yorkshire Research Ethics Committee and Health Research Authority (21/HRA/5245). Site-specific approvals were obtained from the research and innovation offices at Leeds Teaching Hospital and Hull Teaching Hospital. Trial findings will be disseminated through peer-reviewed publications and via participating sites.

ISRCTN86926298.

For every 100 women having a vaginal birth, approximately four will experience a severe (third-degree or fourth-degree) perineal tear. Severe perineal tears are associated with significant short-term and long-term consequences if not recognised and repaired. There are global efforts to reduce incidence of severe perineal tears including initiatives to strengthen education and training of clinicians in perineal anatomy and perineal tear assessment and classification. This systematic review aimed to describe and evaluate the effectiveness of these initiatives.

Systematic review, reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.

Medline (Ovid), CINAHL Complete (EBSCO), MIDIRS and EMBASE (Ovid) were searched through 15 February 2024.

Studies reporting simple or complex interventions aimed at improving the skills and knowledge of clinicians in perineal anatomy and/or the clinical assessment and classification of perineal tears were eligible.

Two reviewers independently screened studies for eligibility and appraised the quality of individual studies using the Cochrane Risk of Bias (RoB) 2.0 tool or Risk of Bias in Non-Randomised Studies of Interventions (ROBINS-I) tool.

In total, 7645 citations were screened and 39 studies included. We identified nine unique interventions including training programmes, short workshops and senior obstetrician supervision. Many studies were from high-income countries, in primary care settings and at high risk of bias.

Effective education included practical components, such as hands-on skills and training in perineal anatomy, assessment and classification, rather than senior supervision alone. Ongoing review of practice appears to be crucial for maintaining knowledge and skills. Future research should focus on interventions tailored to limited-resource settings, and the optimal length and intensity of training programmes to assess and classify perineal tears.

CRD42020185431.

Gaps in research evidence lead to research waste. In burns treatment, there is a paucity of reliable evidence or data. This contributes to inconsistent patient care, especially on a global scale, where low-resource countries often lack access to the latest research advancements. This umbrella review was undertaken as part of the James Lind Alliance Priorities in Global Burns Research Prioritisation Setting Partnership (PSP) and aimed to identify and assess the quality of evidence in thermal burns care. The objective was to map which interventions in thermal burns care are supported by a reliable evidence base and for which the evidence is lacking.

Systematic reviews of randomised controlled trials in thermal burns were identified and assessed using reliability criteria determined a priori. Multiple systematic review databases were searched in June 2023, including the Cochrane Library, KSR Evidence database and NIHR Journals Library. Summary of findings and, where available, Grading of Recommendations Assessment, Development and Evaluation was used to assess certainty of evidence. Reliable reviews were mapped onto clinical categories identified by patients, carers and healthcare professionals as part of the PSP.

232 systematic reviews were identified, of which 83 met reliability criteria and were included. The main reason for not meeting reliability criteria was poorly defined eligibility criteria (n=128). Of the 83 reliable reviews, most were conducted in pain (n=28) or wound management (n=14) and acute care (n=13). Certainty of evidence was mixed. Reviews mapped onto nine of the 17 clinical categories identified by the PSP.

This review summarises the available high-quality evidence in burns care and identifies evidence gaps, indicating that many important clinical questions remain unanswered. There is a discrepancy between the treatments investigated in high-quality research and the clinical areas considered as most important to stakeholders. These findings provide direction for future research to improve global burns care.

To estimate the proportion and correlates of self-reported financial difficulty among patients with multiple myeloma (MM) or chronic lymphocytic leukaemia (CLL).

Sixty-six US community and minority oncology practices affiliated with the National Cancer Institute Community Oncology Research Programme (NCORP).

A total of 521 patients (≥18 years) with MM or CLL consented and 416 responded to a survey (completion rate=79.8%). Respondents had a MM diagnosis (74.0%), an associate degree or higher (53.4%), were White (89.2%), insured (100%) and treated with clinician-administered drugs (68.0%).

Observational, theoretical model and protocol-based patient survey administered between May 2019 and June 2020.

Financial difficulty was assessed using a single-item measure, the EORTC QLQC30: ‘Has your physical condition or medical treatment caused you financial difficulties in the past year?’ and using an ‘any-or-none’ composite measure of 22 items assessing financial difficulty, worries and the use of cost-coping strategies. Multivariable logistic regression models assessed the association of financial difficulty with diagnosis, socioeconomic and treatment characteristics.

About 16.8% reported experiencing financial difficulty using the single-item measure and 60.3% using the composite measure. Most frequently endorsed items in the composite measure were financial worry about having to pay large medical bills related to cancer and difficulty paying medical bills. Financial difficulty using the single-item measure was associated with having MM vs CLL (adjusted OR (aOR), 0.34; 95% CI, 0.13 to 0.84; p=0.02), having insurance other than Medicare (aOR, 2.53; 95% CI, 1.37 to 4.66; p=0.003), being non-White (aOR, 2.21; 95% CI, 1.04 to 4.72; p=0.04) and having a high school education or below (aOR, 0.36; 95% CI, 0.21 to 0.64; p=0.001). Financial difficulty using the composite measure was associated with having a high school education or below (aOR, 0.62; 95% CI, 0.41 to 0.94; p=0.03).

US patients with MM and CLL report financial difficulty, especially those with low socio-economic status. Interventions are needed to mitigate patients’ financial difficulty.

NCT03870633.

Patient activation (PAct)—a measure assessing an individual’s perceived knowledge, skills and confidence in managing their health and well-being—is often used to personalise and evaluate care, although its causal link to self-management behaviours (SMBs) and clinical outcomes remains uncertain. We aimed to synthesise the evidence on the causal association between PAct, SMBs and clinical outcomes in type 2 diabetes (T2D).

Systematic review and narrative synthesis of data summarised in a harvest plot.

We searched Medline, Embase, CENTRAL, PsycInfo, Web of Science and CINAHL up to April 2024 for relevant English articles.

We included studies of any quantitative design that reported on the association of PAct with clinical outcomes or SMBs in adult patients with T2D.

Two independent reviewers were involved, and any disagreements were discussed and resolved collaboratively. Risk-of-bias (RoB) was assessed using an adapted RoB Assessment Tool for Nonrandomised Studies. Levels of evidence were evaluated for each T2D-related outcome.

We identified 21 studies published between 2009 and 2023, including 15 cross-sectional studies and no randomised controlled trials. Eleven studies were conducted in the USA. Seventeen studies used the Patient Activation Measure questionnaire. There is moderate evidence that higher PAct scores are associated with better glycated haemoglobin levels (studies reporting on this association, n=14). There is very limited evidence that PAct improves diet (n=5) and physical activity (n=6). All other clinical outcomes and SMBs had inconclusive results due to either inconsistent or insufficient evidence, or both.

A causal relationship between PAct, clinical outcomes and SMBs in T2D cannot be established due to inconsistent evidence and a lack of high-quality studies. Thus, the use of PAct scores as a tailoring tool and an outcome measure in healthcare services requires further evaluation.

CRD42021230727.

This study aims to provide an in-depth analysis of the symptoms, coexisting conditions and service utilisation among people with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and long COVID. The major research questions include the clustering of symptoms, the relationship between key factors and diagnosis time, and the perceived impact of National Institute for Health and Care Excellence (NICE) guidelines on patient care.

Cross-sectional survey using secondary data analysis.

Community-based primary care level across the UK, incorporating online survey participation.

A total of 10 458 individuals responded to the survey, of which 8804 confirmed that they or a close friend/family member had ME/CFS or long COVID. The majority of respondents were female (83.4%), with participants from diverse regions of the UK.

Primary outcomes included prevalence and clustering of symptoms, time to diagnosis, and participant satisfaction with National Health Service (NHS) care, while secondary outcomes focused on symptom management strategies and the perceived effect of NICE guidelines.

Fatigue (88.2%), postexertional malaise (78.2%), cognitive dysfunction (88.4%), pain (87.6%) and sleep disturbances (88.2%) were the most commonly reported symptoms among participants with ME/CFS, with similar patterns observed in long COVID. Time to diagnosis for ME/CFS ranged widely, with 22.1% diagnosed within 1–2 years of symptom onset and 12.9% taking more than 10 years. Despite updated NICE guidelines, only 10.1% of participants reported a positive impact on care, and satisfaction with NHS services remained low (6.9% for ME/CFS and 14.4% for long COVID).

ME/CFS and long COVID share overlapping but distinct symptom clusters, indicating common challenges in management. The findings highlight significant delays in diagnosis and low satisfaction with specialist services, suggesting a need for improved self-management resources and better-coordinated care across the NHS.

To understand the help-seeking experiences of young people from culturally and linguistically diverse (CALD) backgrounds who have experienced suicidal thoughts and behaviours (STB).

Qualitative study using semistructured interviews and reflexive thematic analysis.

A specialist, youth-focused Hospital Outreach Post-suicidal Engagement (HOPE) aftercare service delivered by Orygen in North-West Melbourne, Australia.

Eight young people aged 16–24 years (mean: 18.7±3.1 years, 50% female) from various CALD backgrounds who had been discharged from the HOPE aftercare service within the past 12 months.

Four themes were identified: (1) cultural taboos and generational differences create challenges in communicating with family; (2) isolation is a barrier to reaching out; (3) it’s hard to disclose and discuss STB with clinicians and (4) not being taken seriously in clinical settings.

These findings highlight social, cultural and organisational barriers that shape the help-seeking journeys of young people from CALD backgrounds experiencing STB. Results suggest a need for culturally sensitive suicide prevention strategies, enhanced cultural competency in healthcare settings and efforts to improve mental health literacy within CALD communities.