Title: Using IMPLEMENTation science and Studies Within A Trial (IMPLEMENT SWATs) to improve evidence-based participant recruitment and retention in randomised controlled trials
Funder: Department of Health and Social Care

Abstract: Background Randomised trials are the gold standard for evaluating interventions. However, approximately 50% of trials fail to recruit and retain sufficient participants, causing immense waste described as a scandal, and missing opportunities to save many lives. A 'Study Within A Trial' (SWAT) is a rigorous method for evaluating recruitment and retention strategies; however, very few strategies have robust evidence of effectiveness and cost-effectiveness. Research suggests that trialists do not use evidence to inform their recruitment and retention activities. Through the MRC-funded PROMETHEUS programme, colleagues and I successfully demonstrated the methodological feasibility of evaluating the same recruitment or retention strategy across multiple host trials simultaneously. This paves the way to significantly scale up and accelerate evidence generation for recruitment and retention, which could be aided by guidelines to support their implementation by trial teams. Aims and objectives Identify and prioritise recruitment and retention strategies (Work-package 1 [WP1]). Undertake simultaneous SWATs of the highest priority recruitment and retention strategies [WP2]. Develop guidelines for evidence-based, cost-effective recruitment and retention [WP3]. Develop and execute a guideline implementation strategy [WP4]. Evaluate the effectiveness, cost-effectiveness of the guidelines and implementation strategy, alongside a process evaluation [WP5].Methods The research adopts an implementation science approach. Patient, public and stakeholder involvement will inform each WP. WP1 - Prioritisation: A document review will identify recruitment and retention strategies in NIHR and non-NIHR trials. I will link these strategies to the evidence on effectiveness and cost-effectiveness, and to existing priorities for recruitment and retention, to identify the top ten strategies each for recruitment and retention for future evaluation. WP2 - Simultaneous SWATs: Informed by WP1, I will rapidly build the evidence-base by recruiting host trials to evaluate the effectiveness and cost-effectiveness of the highest priority recruitment and retention strategies using simultaneous SWATs. WP3 -h; Guideline development: Informed by WP1 and WP2, I will develop a guideline for evidence-based trial recruitment and retention. WP4 -h; Implementation strategy: Informed by WP4 and the Theoretical Domains Framework (TDF), I will identify barriers and enablers to the uptake of the guideline, to inform the selection of components to develop and execute an implementation strategy. WP5 -h; Evaluation: I will evaluate guideline uptake using an interrupted time series design, alongside cost-effectiveness and process evaluations. I will look for associations between use of the guideline and recruitment/retention success.Timeline for delivery I will complete the Fellowship over 120 months (50% WTE) to accommodate guideline implementation and evaluation, and to provide opportunities for development outside the Fellowship. WP1 -h; Prioritisation: Months 1-21. WP2 -h; Simultaneous SWATs: Months 4-111. WP3 -h; Guideline development: Months 16-57. Living systematic review (Months 16-120). Guideline update (Months 93-99).WP4 -h; Implementation strategy: Months 46-117. Development (Months 46-63). Execute strategy (Months 63-117).WP5 -h; Evaluation: Months 58-117. Impact and dissemination Academic impact Improved evidence-base for recruitment/retention. Guideline for trialists. Cheaper, faster, efficient trials.Societal/economic impacts Accelerate health benefits from trial results. Reduced research waste. Support NIHR achieve goal of increasing research participation.Dissemination Journal publications. Dissemination events. Presenting at conferences, meetings, and webinars.

Lay abstract: Aims of the research My broad aim is to promote the use of research evidence for recruiting and following up participants in randomised trials testing health treatments. Background Trials are the best way to test how effective health treatments are. However, about half of all trials fail to recruit enough participants, and many participants drop out once they are recruited. These problems with recruitment and retention cause huge amounts of research waste that has been described as a scandal. Poor recruitment and retention have a human cost, too. A study of a COVID-19 trial found that if it had recruited 50% of all suitable patients instead of just 15% (typical for trials of its type), nearly 3000 more lives could have been saved in the UK alone, from patients receiving the effective treatment earlier. A good way to test recruitment and retention strategies is to use a 'Study Within A Trial' (SWAT), which is a piece of research built into a 'host' trial. But not many SWATs have been done, and there are almost no effective and cost-effective strategies for recruiting and retaining participants in trials. In the MRC-funded PROMETHEUS programme, which I was a co-applicant on, we successfully showed that a recruitment or retention strategy can be tested across different host trials and patient groups at the same time to significantly speed up and increase the evidence-base. However, researchers tend to not use evidence when planning recruitment and retention. This may be because there are no guidelines to support the use of evidence-based recruitment and retention strategies, so that strategies that are effective are used, and those that are not effective are avoided. Design and methodsI will use 'implementation science', which is the study of methods to promote the use of research findings. There will be five stages to the research. Firstly, I will identify and prioritise strategies that are used to recruit and retain participants by doing a review of trials published in the UK and elsewhere. Secondly, I will test the highest priority recruitment and retention strategies to see if they are effective and cost-effective, by doing several SWATs at the same time for each strategy. Thirdly, I will bring together all the evidence on the effectiveness and cost-effectiveness of recruitment and retention strategies to develop 'guidelines for evidence-based recruitment and retention'. Fourthly, I will develop and apply a strategy to support members of the trial community to use the guidelines (an 'implementation strategy'), which will be based on the psychology of behaviour. Finally, I will use different methods to test the effectiveness and cost-effectiveness of the implementation strategy, and to explore whether using the guideline is associated with better recruitment and retention. Patient and public involvement (PPI) To plan this research, I met with nine patients and carers. There was enthusiasm for the research, which was felt to be important for future patient health. Structured feedback was given on the relevance of the research question and planned outcomes, ethics, risks, burden, logistics, information, and dissemination. Feedback on the plain language summary led to significant revisions. A PPI Panel of six members will be formed for the Fellowship. Members will contribute to all parts of the research, include the Guideline. They will help to develop the following for the entire trial community, including other PPI members: A plain language version of the Guideline. An animated video. Easy-to-understand summaries using visual 'infographics'.Dissemination My dissemination plans include: Publishing findings in academic journals. Sharing summaries of findings, presenting at conferences, to trial teams as well as patient groups. Organising dissemination events to share findings.

Research activity codes: 8.4 RESEARCH DESIGN AND METHODOLOGIES (HEALTH SERVICES)
Health categories: GENERIC HEALTH RELEVANCE