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Abstract Background Use of electronic methods to support informed consent (‘eConsent’) is increasingly popular in clinical research. This commentary reports the approach taken to implement electronic consent methods and subsequent experiences from a range of studies at the Leeds Clinical Trials Research Unit (CTRU), a large clinical trials unit in the UK. Main text We implemented a remote eConsent process using the REDCap platform. The process can be used in trials of investigational medicinal products and other intervention types or research designs. Our standard eConsent system focuses on documenting informed consent, with other aspects of consent (e.g. providing information to potential participants and a recruiter discussing the study with each potential participant) occurring outside the system, though trial teams can use electronic methods for these activities where they have ethical approval. Our overall process includes a verbal consent step prior to confidential information being entered onto REDCap and an identity verification step in line with regulator guidance. We considered the regulatory requirements around the system’s generation of source documents, how to ensure data protection standards were upheld and how to monitor informed consent within the system. We present four eConsent case studies from the CTRU: two randomised clinical trials and two other health research studies. These illustrate the ways eConsent can be implemented, and lessons learned, including about differences in uptake. Conclusions We successfully implemented a remote eConsent process at the CTRU across multiple studies. Our case studies highlight benefits of study participants being able to give consent without having to be present at the study site. This may better align with patient preferences and trial site needs and therefore improve recruitment and resilience against external shocks (such as pandemics). Variation in uptake of eConsent may be influenced more by site-level factors than patient preferences, which may not align well with the aspiration towards patient-centred research. Our current process has some limitations, including the provision of all consent-related text in more than one language, and scalability of implementing more than one consent form version at a time. We consider how enhancements in CTRU processes, or external developments, might affect our approach.

Abstract Background People with type 1 diabetes and raised glucose levels are at greater risk of retinopathy, nephropathy, neuropathy, cardiovascular disease, sexual health problems and foot disease. The UK National Institute for Health and Care Excellence (NICE) recommends continuous subcutaneous ‘insulin pump’ therapy for people with type 1 diabetes whose HbA1c is above 69 mmol/mol. Insulin pump use can improve quality of life, cut cardiovascular risk and increase treatment satisfaction. About 90,000 people in England and Wales meet NICE criteria for insulin pumps but do not use one. Insulin pump use also varies markedly by deprivation, ethnicity, sex and location. Increasing insulin pump use is a key improvement priority. Audit and feedback is a common but variably effective intervention. Limited capabilities of healthcare providers to mount effective responses to feedback from national audits, such as the National Diabetes Audit (NDA), undermines efforts to improve care. We have co-developed a theoretically and empirically informed quality improvement collaborative (QIC) to strengthen local responses to feedback with patients and carers, national audits and healthcare providers. We will evaluate whether the QIC improves the uptake of insulin pumps following NDA feedback. Methods We will undertake an efficient cluster randomised trial using routine data. The QIC will be delivered alongside the NDA to specialist diabetes teams in England and Wales. Our primary outcome will be the proportion of people with type 1 diabetes and an HbA1c above 69 mmol/mol who start and continue insulin pump use during the 18-month intervention period. Secondary outcomes will assess change in glucose control and duration of pump use. Subgroup analyses will explore impacts upon inequalities by ethnicity, sex, age and deprivation. A theory-informed process evaluation will explore diabetes specialist teams’ engagement, implementation, fidelity and tailoring through observations, interviews, surveys and documentary analysis. An economic evaluation will micro-cost the QIC, estimate cost-effectiveness of NDA feedback with QIC and estimate the budget impact of NHS-wide QIC roll out. Discussion Our study responds to a need for more head-to-head trials of different ways of reinforcing feedback delivery. Our findings will have implications for other large-scale audit and feedback programmes. Trial registration ISRCTN82176651 Registered 18 October 2022.

Abstract Background To address the limited provision of longer-term stroke care, we conducted a programme of research (LoTS2Care) to develop and test an intervention to form part of a replicable longer-term care strategy. New Start, a programme of facilitated self-management, was developed to be delivered at 6 months post-stroke by trained facilitators. Here, we report the findings from the final workstream of this programme, which aimed to evaluate the feasibility and acceptability of implementing a future definitive cluster randomised controlled trial of the developed intervention (New Start) to support stroke survivors and their carers in the longer term. Methods A feasibility cluster randomised controlled trial was conducted in English and Welsh NHS stroke services. Stroke services (clusters) were randomised on a 1:1 basis to implement New Start or continue with usual care only. Community-dwelling stroke survivors between 4 and 6 months post-stroke were invited to participate in the trial by post. Outcome measures were collected via post at 3, 6 and 9 months after recruitment. Recruitment and follow-up rates, delivery and uptake of the intervention, data collection feasibility (including postal outcome measures of health and disability, mental well-being at 3, 6, and 9 months post-recruitment) and safety were assessed. Results Ten stroke services were recruited. A total of 1127 stroke survivors were screened for participation, and 269 were registered (New Start, n = 145; usual care, n = 124). Retention was high with 239 (89%) stroke survivors being available for follow-up at 9 months, and high return rates of postal questionnaires were achieved (80.3% at 9 months). Intervention training was successfully delivered, and New Start was offered to 95.2% of trial participants in the intervention arm. Uptake was variable, however, ranging from 11.8 to 75.0%. There were no safety concerns. Conclusions Stroke service recruitment and longer-term stroke survivor postal recruitment and outcome data collection are feasible; however, refinement of intervention targeting and delivery is required prior to undertaking a definitive trial. Trial registration ISRCTN38920246. Registered 22 June 2016 ( http://www.isrctn.com/ISRCTN38920246 ).

Introduction Stroke survivors spend long periods of time engaging in sedentary behaviour (SB) even when their functional recovery is good. In the RECREATE programme, an intervention aimed at reducing SB (‘Get Set Go’) will be implemented and evaluated in a pragmatic external pilot cluster randomised controlled trial with embedded process and economic evaluations. We report the protocol for the process evaluation which will address the following objectives: (1) describe and clarify causal assumptions about the intervention, and its mechanisms of impact; (2) assess implementation fidelity; (3) explore views, perceptions and acceptability of the intervention to staff, stroke survivors and their carers; (4) establish the contextual factors that influence implementation, intervention mechanisms and outcomes.Methods and analysis This pilot trial will be conducted in 15 UK-based National Health Service stroke services. This process evaluation study, underpinned by the Medical Research Council guidance, will be undertaken in six of the randomised services (four intervention, two control). Data collection includes the following: observations of staff training sessions, non-participant observations in inpatient and community settings, semi-structured interviews with staff, patients and carers, and documentary analysis of key intervention components. Additional quantitative implementation data will be collected in all sites. Training observations and documentary analysis data will be summarised, with other observational and interview data analysed using thematic analysis. Relevant theories will be used to interpret the findings, including the theoretical domains framework, normalisation process theory and the theoretical framework of acceptability. Anticipated outputs include the following: recommendations for intervention refinements (both content and implementation); a revised implementation plan and a refined logic model.Ethics and dissemination The study was approved by Yorkshire & The Humber - Bradford Leeds Research Ethics Committee (REC reference: 19/YH/0403). Findings will be disseminated via peer review publications, and national and international conference presentations.Trial registration number ISRCTN82280581.

Introduction Sedentary behaviour (sitting or lying during waking hours without being otherwise active) is strongly associated with adverse health outcomes, including all-cause, cancer and cardiovascular mortality in adults. Stroke survivors are consistently reported as being more sedentary than healthy age-matched controls, spending more hours sedentary daily and sustaining longer unbroken bouts of sedentary time. An evidence-based and clinically feasible intervention (‘Get Set Go’) was developed. A pragmatic definitive trial to evaluate Get Set Go was planned; however, due to the unprecedented effects of the COVID-19 pandemic on National Health Service (NHS) services this study was reduced in size and scope to become an external pilot trial. We report the protocol for this external pilot trial, which aims to undertake a preliminary exploration of whether Get Set Go is likely to improve ability to complete extended activities of daily living in the first year post-stroke and inform future trial designs in stroke rehabilitation.Methods and analysis This study is a pragmatic, multicentre, two-arm, external pilot cluster randomised controlled trial with embedded process and economic evaluations. UK-based stroke services will be randomised 1:1 to the intervention (usual care plus Get Set Go) or control (usual care) arm. Fifteen stroke services will recruit 300–400 stroke inpatient and carer participants, with follow-up at 6, 12 and 24 months. The proposed primary endpoint is stroke survivor self-reported Nottingham Extended Activities of Daily Living scale at 12 months. Endpoint analyses will be exploratory and provide preliminary estimates of intervention effect. The process evaluation will provide valuable information on intervention fidelity, acceptability and how it can be optimised.Ethics and dissemination The study has been approved by Yorkshire and The Humber – Bradford-Leeds Research Ethics Committee (Ref: 19/YH/0403). Results will be disseminated through journal publications and conference presentations.Trial registration number This trial was registered prospectively on 01 April 2020 (ISRCTN ref: ISRCTN82280581).

Background: Blood transfusion is a common but costly treatment. Repeated national audits in the UK suggest that up to one-fifth of transfusions are unnecessary when judged against recommendations for good clinical practice. Audit and feedback seeks to improve patient care and outcomes by comparing clinical care against explicit standards. It is widely used internationally in quality improvement. Audit and feedback generally has modest but variable effects on patient care. A considerable scope exists to improve the impact that audit and feedback has, particularly through head-to-head trials comparing different ways of delivering feedback. Objectives: The AFFINITIE (Development & Evaluation of Audit and Feedback INterventions to Increase evidence-based Transfusion practIcE) programme aimed to design and evaluate enhanced feedback interventions, within a national blood transfusion audit programme, to promote evidence-based guidance and reduce the unnecessary use of blood components. We developed, piloted and refined two feedback interventions, ‘enhanced content’ and ‘enhanced follow-on’ (workstream 1), evaluated the effectiveness and cost-effectiveness of the two feedback interventions compared with standard feedback practice (workstream 2), examined intervention fidelity and contextual influences (workstream 3) and developed general implementation recommendations and tools for other audit and feedback programmes (workstream 4). Design: Interviews, observations and documentary analysis in four purposively sampled hospitals explored contemporary practice and opportunities for strengthening feedback. We developed two interventions: ‘enhanced content’, to improve the clarity and utility of feedback reports, and ‘enhanced follow-on’, to help hospital staff with action-planning (workstream 1). We conducted two linked 2 × 2 factorial cross-sectional cluster-randomised trials within transfusion audits for major surgery and haematological oncology, respectively (workstream 2). We randomised hospital clusters (the organisational level at which hospital transfusion teams operate) to enhanced or standard content or enhanced or standard follow-on. Outcome assessment was masked to assignment. Decision-analytic modelling evaluated the costs, benefits and cost-effectiveness of the feedback interventions in both trials from the perspective of the NHS. A parallel process evaluation used semistructured interviews, documentary analyses and web analytics to assess the fidelity of delivery, receipt and enactment and to identify contextual influences (workstream 3). We explored ways of improving the impact of national audits with their representatives (workstream 4). Setting and participants: All NHS hospital trusts and health boards participating in the National Comparative Audit of Blood Transfusions were invited to take part. Among 189 hospital trusts and health boards screened, 152 hospital clusters participated in the surgical audit. Among 187 hospital trusts and health boards screened, 141 hospital clusters participated in the haematology audit. Interventions: ‘Enhanced content’ aimed to ensure that the content and format of feedback reports were consistent with behaviour change theory and evidence. ‘Enhanced follow-on’ comprised a web-based toolkit and telephone support to facilitate local dissemination, planning and response to feedback. Main outcome measures: Proportions of acceptable transfusions, based on existing evidence and guidance and algorithmically derived from national audit data. Data sources: Trial primary outcomes were derived from manually collected, patient-level audit data. Secondary outcomes included routinely collected data for blood transfusion. Results: With regard to the transfusions in the major surgery audit, 135 (89%) hospital clusters participated from 152 invited. We randomised 69 and 66 clusters to enhanced and standard content, respectively, and 68 and 67 clusters to enhanced and standard follow-on, respectively. We analysed a total of 2222 patient outcomes at 12 months in 54 and 58 (enhanced and standard content, respectively) and 54 and 58 (enhanced and standard follow-on, respectively) hospital clusters. With regard to the haematology audit, 134 hospital clusters (95%) participated from 141 invited. We randomised 66 and 68 clusters to enhanced and standard content, respectively, and 67 clusters to both enhanced and standard follow-on. We analysed a total of 3859 patient outcomes at 12 months in 61 and 61 (enhanced and standard content, respectively) and 63 and 59 (enhanced and standard follow-on) hospital clusters. We found no effect of either of the enhanced feedback interventions in either trial across all outcomes. Incremental enhanced intervention costs ranged from £18 to £248 per site. The enhanced feedback interventions were dominated by the standard intervention in cost-effectiveness analyses. The interventions were delivered as designed and intended, but subsequent local engagement was low. Although the enhancements were generally acceptable, doubts about the credibility of the blood transfusion audits undermined the case for change. Limitations: Limitations included the number of participating clusters; loss to follow-up of trial clusters, reducing statistical power and validity; incomplete audit and cost data contributing to outcome measures; participant self-selection; reporting; missing data related to additional staff activity generated in response to receiving feedback; and recall biases in the process evaluation interviews. Conclusions: The enhanced feedback interventions were acceptable to recipients but were more costly and no more effective than standard feedback in reducing unnecessary use of blood components, and, therefore, should not be recommended on economic grounds. Future work: We have demonstrated the feasibility of embedding ambitious large-scale rigorous research within national audit programmes. Further head-to-head comparisons of different feedback interventions are needed in these programmes to identify cost-effective ways of increasing the impact of the interventions. Trial registration: This trial is registered as ISRCTN15490813. Funding: This project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 10, No. 2. See the NIHR Journals Library website for further project information.

Background: It is reported that the longer-term outcomes for stroke survivors are poor, with a range of unmet needs identified. Objectives: The aims were to develop and test a longer-term stroke care strategy focused on improving the quality of life of stroke survivors and their carers by addressing unmet needs, and maintenance and enhancement of participation (i.e. involvement in life situations). Design: Five overlapping workstreams were undertaken – (1) refinement of content by semistructured interviews with stroke survivors and their carers and by a review of the literature to inform content and delivery of the care strategy; (2) exploration of service models by national survey and focus groups with purposely selected services; (3) intervention development by interaction with a reference group of stroke survivors, carers, and health and social care professionals; (4) refinement and pilot implementation of the developed intervention in three stroke services (case studies); and (5) a cluster randomised controlled feasibility trial in 10 stroke services across England and Wales. Setting: The intervention development work and feasibility trial were in stroke services (inclusive of primary, secondary, community and social care provision) across England and Wales. Participants: Participants were stroke survivors resident in the community and their carers, and health and social care professionals in the included stroke services. Data sources: Interviews with 28 stroke survivors and their carers at least 9 months post stroke ascertained their needs and the barriers to and facilitators of addressing those needs. Additional literature reviews identified 23 needs. No evidence-based interventions to address these needs were reported; self-management was highlighted as a possible delivery mechanism. In workstream 2, a national survey revealed that the most common model of stroke service provision was care up to 12 months post stroke, reported by 46 (40%) services. Thirty-five (30%) services provided care up to 6 months post stroke and 35 (30%) provided care beyond 12 months, thus identifying 6 months post stroke as an appropriate delivery point for a new intervention. Through focus groups in a range of services, stroke survivors’ perceived unmet needs and the barriers to and enablers of service provision were identified. Intervention: Using information obtained in workstreams 1 and 2 and working closely with a stakeholder reference group, we developed an intervention based on the unmet needs prioritised by stroke survivors and their carers (workstream 3). In workstream 4, action groups (clinicians, stroke survivors and researchers) were established in three stroke services that led implementation in their service and contributed to the iterative refinement of the intervention, associated training programme and implementation materials. The intervention (called New Start) was delivered at 6 months post stroke. Key components were problem-solving self-management with survivors and carers, help with obtaining usable information, and helping survivors and their carers build sustainable, flexible support networks. Results: A cluster randomised feasibility trial (workstream 5) was successfully implemented in 10 stroke services across England and Wales, with associated process and health economic evaluations. Five services were randomised to provide New Start, while five continued with usual care; 269 participants were recruited. Progression criteria – in terms of our pre-determined (red, amber, green) criteria for progress to a full trial: target stroke survivor recruitment rates were achieved, on average, across sites (24.1 per site over 6 months, green); 216 (80.3%) registered stroke survivors returned follow-up questionnaires at 9 months (84.1% in the intervention arm and 75.8% in the usual care arm, green); according to data reported by sites, overall, 95.2% of registered stroke survivors were offered at least one session of the intervention (green); all five intervention sites had at least two facilitators deemed competent, delivered the New Start intervention and provided it to stroke survivors (green). However, at some sites, there were concerns regarding the number of stroke survivors being offered, accepting and receiving the intervention. Only small differences in outcomes and costs were observed between the New Start and usual care groups, and considerable uncertainty around the cost-effectiveness remains. Conclusions: We report a complex programme of work that has described the longer-term needs of stroke survivors and highlighted evidence and service gaps. Working closely with stroke survivors, an intervention was developed that has been refined in three services and feasibility tested in a cluster randomised controlled trial. Further refinement of the target population and optimisation of the intervention materials is required prior to a full randomised controlled trial evaluation. Future work: Optimisation of the intervention, and clearer specification of recipients, are required prior to a full trial evaluation. Trial registration: Current Controlled Trials ISRCTN38920246. Funding: This project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 9, No. 3. See the NIHR Journals Library website for further project information.

Abstract Background Despite the evidence that many stroke survivors report longer term unmet needs, the provision of longer term care is limited. To address this, we are conducting a programme of research to develop an evidence-based and replicable longer term care strategy. The developed complex intervention (named New Start), which includes needs identification, exploration of social networks and components of problem solving and self-management, was designed to improve quality of life by addressing unmet needs and increasing participation. Methods/Design A multicentre, cluster randomised controlled feasibility trial designed to inform the design of a possible future definitive cluster randomised controlled trial (cRCT) and explore the potential clinical and cost-effectiveness of New Start. Ten stroke services across the UK will be randomised on a 1:1 basis either to implement New Start or continue with usual care only. New Start will be delivered by trained facilitators and will be offered to all stroke survivors within the services allocated to the intervention arm. Stroke survivors will be eligible for the trial if they are 4–6 months post-stroke and residing in the community. Carers (if available) will also be invited to take part. Invitation to participate will be initiated by post and outcome measures will be collected via postal questionnaires at 3, 6 and 9 months after recruitment. Outcome data relating to perceived health and disability, wellbeing and quality of life as well as unmet needs will be collected. A ‘study within a trial’ (SWAT) is planned to determine the most acceptable format in which to provide the postal questionnaires. Details of health and social care service usage will also be collected to inform the economic evaluation. The feasibility of recruiting services and stroke survivors to the trial and of collecting postal outcomes will be assessed and the potential for effectiveness will be investigated. An embedded process evaluation (reported separately) will assess implementation fidelity and explore and clarify causal assumptions regarding implementation. Discussion This feasibility trial with embedded process evaluation will allow us to gather important and detailed data regarding methodological and implementation issues to inform the design of a possible future definitive cRCT of this complex intervention. Trial Registration ISRCTN38920246. Registered 22 June 2016.