Using IMPLEMENTation science and Studies Within A Trial (IMPLEMENT SWATs) to improve evidence-based participant recruitment and retention in randomised controlled trials

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 - Guideline development: Informed by WP1 and WP2, I will develop a guideline for evidence-based trial recruitment and retention. WP4 - 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 - 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 - Prioritisation: Months 1-21. WP2 - Simultaneous SWATs: Months 4-111. WP3 - Guideline development: Months 16-57. Living systematic review (Months 16-120). Guideline update (Months 93-99). WP4 - Implementation strategy: Months 46-117. Development (Months 46-63). Execute strategy (Months 63-117). WP5 - 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.