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The number of people living with multiple long-term conditions (MLTCs or ‘multimorbidity’) is growing. Evidence indicates that exercise-based rehabilitation can improve health-related quality of life and reduce hospital admissions for a number of single long-term conditions. However, it is increasingly recognised that such condition-focused rehabilitation programmes do not meet the needs of people living with MLTCs. The aims for this study were to (1) evaluate the acceptability and feasibility of the newly developed Personalised Exercise Rehabilitation FOR people with Multiple long-term conditions (PERFORM) intervention; (2) assess the feasibility of study methods to inform progression to a definitive randomised controlled trial (RCT) and (3) refine our intervention programme theory.
Semi-structured qualitative interviews were conducted with patients receiving and healthcare practitioners delivering the PERFORM intervention, to seek their experiences of the intervention and taking part in the study. Interviews were analysed thematically, informed by Normalisation Process Theory and the programme theory.
Three UK sites (two acute hospital settings, one community-based healthcare setting).
18 of the 60 PERFORM participants and 6 healthcare professionals were interviewed.
The intervention consisted of 8 weeks of supervised group-based exercise rehabilitation and structured self-care symptom-based support.
All participants and staff interviewed found PERFORM useful for physical and mental well-being and noted positive impacts of participation, although some specific modifications to the intervention delivery and training and study methods were identified. Scheduling, staffing and space limitations were barriers that must be considered for future evaluation and implementation. Key intervention mechanisms identified were social support, patient education, building routines and habits, as well as support from healthcare professionals.
We found the PERFORM intervention to be acceptable and feasible, with the potential to improve the health and well-being of people with MLTCs. The findings of the process evaluation inform the future delivery of the PERFORM intervention and the design of our planned full RCT. A definitive trial is needed to assess the clinical and cost-effectiveness.
Existing exercise-based rehabilitation services, such as cardiac and pulmonary rehabilitation, are traditionally commissioned around single long-term conditions (LTCs) and therefore may not meet the complex needs of adults with multiple long-term conditions (MLTCs) or multimorbidity. The aim of this study was to assess the feasibility and acceptability of the newly developed personalised exercise-rehabilitation programme for people with multiple long-term conditions (PERFORM) and the trial methods.
A parallel two-group mixed-methods feasibility randomised controlled trial (RCT) with embedded process and economic evaluation.
Three UK sites (two acute hospital settings, one community-based healthcare setting).
60 adults with MLTCs (defined as the presence of ≥2 LTCs) with at least one known to benefit from exercise therapy were randomised 2:1 to PERFORM intervention plus usual care (PERFORM group) or usual care alone (control group).
The intervention consisted of 8 weeks of supervised group-based exercise rehabilitation and structured self-care symptom-based support.
Primary feasibility outcomes included: trial recruitment (percentage of a target of 60 participants recruited within 4.5 months), retention (percentage of participants with complete EuroQol data at 3 months) and intervention adherence (percentage of intervention group attending ≥60% sessions). Other feasibility measures included completion of outcome measures at baseline (pre-randomisation), 3 months post-randomisation (including patient-reported outcomes, exercise capacity and collection of health and social care resource use) and intervention fidelity.
Target recruitment (40 PERFORM group, 20 control group) was met within the timeframe. Participants were 57% women with a mean (SD) age of 62 (13) years, body mass index of 30.8 (8.0) kg/m2 and a median of 4 LTCs (most common: diabetes (41.7%), hypertension (38.3%), asthma (36.7%) and a painful condition (35.0%)). We achieved EuroQol outcome retention of 76.7% (95% CI: 65.9% to 87.1%; 46/60 participants) and intervention adherence of 72.5% (95% CI: 56.3% to 84.4%; 29/40 participants). Data completion for attendees was over 90% for 11/18 outcome measures.
Our findings support the feasibility and rationale for delivering the PERFORM comprehensive self-management and exercise-based rehabilitation intervention for people living with MLTCs and progression to a full multicentre RCT to formally assess clinical effectiveness and cost-effectiveness.
To identify and synthesise the ethical, feasibility and acceptability challenges associated with implementing eye-tracking research with clinicians in acute care settings and to explore strategies to address these concerns.
Scoping review using the Joanna Briggs Institute methodology.
Six databases (MEDLINE, CINAHL, EMBASE, Web of Science, APA PsycInfo and ProQuest Dissertations & Theses Global) were searched for peer-reviewed articles. Reference lists of included studies were also hand-searched.
Eligible studies involved clinicians using or interacting with eye-tracking devices in acute care environments and addressed at least one ethical, feasibility, or acceptability consideration. Data were extracted and thematically analysed. Knowledge users, including clinicians, ethicists and a patient partner, were engaged during protocol development and findings synthesis.
Twenty-five studies published from 2010 to 2024 were included. Seven challenges were identified: obtaining ethical approval, managing consent, privacy and confidentiality concerns, collecting data in unpredictable environments, interference with care, participant comfort and data loss or unreliability. Knowledge users highlighted the importance of early institutional engagement, clear protocols, continuous consent and context-sensitive ethical reflection.
Eye-tracking offers valuable insights into clinician behaviour and cognition, but its implementation in acute care raises complex ethical and methodological issues. Responsible use requires anticipatory planning, stakeholder engagement and flexible yet rigorous protocols.
By informing the development of ethically sound study protocols and consent practices, this work contributes to safer, more transparent and patient-centred research that respects participant autonomy and protects clinical workflows.
The protocol was registered with the Open Science Framework (https://osf.io/jn4yx).
Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA; Page et al., 2021) and its Extension for Scoping Reviews (Tricco et al., 2018).
A patient partner was involved in protocol development, interpretation of findings and development of study recommendations. Their contributions included participating in advisory groups and providing feedback alongside clinicians and ethicists during focus groups. This input helped ensure the research addressed patient-relevant priorities and informed the development of ethically responsible practices for conducting eye-tracking research in clinical care settings.
Individual participant data meta-analysis (IPD-MA) is regarded as the gold standard for evidence synthesis. However, diverse recommendations and guidance on its conduct exist, and there is no consensus-based tool for the critical appraisal of a completed IPD-MA. We aim to close this gap by systematically identifying quality items and developing and validating a critical appraisal checklist for IPD-MA.
This study will comprise three phases, as follows:
Phase 1: a systematic methodology review to identify potential checklist domains and items; this will be conducted according to the Cochrane methods for systematic reviews and reported following the Preferred Reporting Items for Systematic Reviews and Meta-analysis 2020 guidance. We will include studies that address methodological guides and essential statistical requirements for IPD-MA. We will use the proposed items to prepare a preliminary checklist for the e-Delphi study.
Phase 2: at least two rounds of an e-Delphi survey will be conducted among panels with expertise in IPD-MA research, consensus development, healthcare providers, journal editors, healthcare policymakers, patients and public partners from diverse geographic locations with experience in IPD-MA. Participants will use Qualtrics software to rate items on a 5-point Likert scale. The Wilcoxon matched signed rank test will estimate response stability across rounds. Consensus on including an item will be achieved if ≥75% of the panel rates the item as ‘strongly agree’ or ‘agree’ and items will be excluded if ≥75% rates it as ‘strongly disagree’ or ‘disagree’. A convenience sample of 10 reviewers with experience in conducting an IPD-MA will pilot-test the checklist to provide practical feedback that will be used to refine the checklist.
Phase 3: critical appraisal checklist validation: to improve confidence in the tool’s uptake, a subset of the e-Delphi participants and graduate students of epidemiology and biostatistics will conduct content validity and reliability testing, respectively, per the Consensus-based Standards for the Selection of Health Measurement Instruments.
Ethics approval has been obtained from the Western University Health Science Research Ethics Board in Canada. The validated checklist will be published in a peer-reviewed open-access journal and shared across the networks of this study’s steering committee, Cochrane IPD-MA group and the institutions’ social media platforms.
Heart failure with preserved ejection fraction (HFpEF) is common and causes functional limitation, poor health-related quality of life (HRQoL) and impairs prognosis. Exercise-based cardiac rehabilitation is a promising intervention for HFpEF, but there is currently insufficient evidence to support its routine use. This trial will assess the clinical and cost-effectiveness of a 12-week health professional-facilitated, home-based rehabilitation intervention (REACH-HF), in people with HFpEF, for participants and their caregivers.
REACH-HFpEF is a parallel two group multicentre randomised controlled trial with 1:1 individual allocation to the REACH-HF intervention plus usual care (intervention group) or usual care alone (control group) with a target sample size of 372 participants with HFpEF and their caregivers recruited from secondary care centres in United Kingdom. Outcome assessment and statistical analysis will be performed blinded; outcomes will be assessed at baseline and 4-month and 12-month follow-up. The primary outcome measure will be patients’ disease-specific HRQoL, measured using the Minnesota Living with Heart Failure questionnaire, at 12 months. Secondary outcomes include patient's exercise capacity, psychological well-being, level of physical activity, generic HRQoL, self-management, frailty, blood biomarkers, mortality, hospitalisations, and serious adverse events, and caregiver's HRQoL and burden. A process evaluation and substudy will assess the fidelity of intervention delivery and adherence to the home-based exercise regime and explore potential mediators and moderators of changes in HRQoL with the intervention. Qualitative studies will describe facilitators’ experiences of delivery of the intervention. A cost-effectiveness analysis (CEA) of the REACH-HF intervention in participants with HFpEF will estimate incremental cost per quality-adjusted life year at 12 months. The CEA will be conducted from a UK NHS and Personal Social Services perspective and a wider societal perspective. The adequacy of trial recruitment in an initial 6-month internal pilot period will also be checked.
The study is approved by the West of Scotland Research Ethics Committee (ref 21/WS/0085). Results will be disseminated via peer-reviewed journal publication and conference presentations to researchers, service users and policymakers.
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