What are the most important unanswered research questions in trial retention? A James Lind Alliance Priority Setting Partnership – The PRioRiTy II (Prioritising Retention in Randomised Trials) Study

Abstract Background One of the top three research priorities for the UK clinical trial community is to address the gap in evidence-based approaches to improving participant retention in randomised trials. Despite this, there is little evidence supporting methods to improve retention. This paper reports the PRioRiTy II project, a Priority Setting Partnership (PSP) that identified and prioritised unanswered questions and uncertainties around trial retention in collaboration with key stakeholders. Methods This PSP was conducted in collaboration with the James Lind Alliance, a non-profit making initiative to support key stakeholders (researchers, patients and public) in jointly identifying and agreeing priority research questions. There were three stages (i) An initial online survey consisting of six open-ended questions about retention in randomised trials. Responses were coded into thematic groups to create a longlist of questions. The longlist of questions was checked against existing evidence to ensure they had not been answered by existing research. (ii) An interim stage, which involved a further online survey where stakeholders were asked to select questions of key importance from the longlist.. (iii) A face-to-face consensus meeting, where key stakeholder representatives agreed an ordered list of 21 unanswered research questions for methods of improving retention in randomised trials. Results 456 respondents yielded 2,431 answers to six open ended questions, from which 372 questions specifically about retention were identified. Further analysis included thematically grouping all data items within answers and merging questions in consultation with the steering group. This produced 27 questions for further rating during the interim survey. The top 21 questions from the interim online survey were brought to a face-to-face consensus meeting, in which key stakeholder representatives prioritised the order. The Top 10 of these is reported in this paper. The number one ranked question was “What motivates a participant’s decision to complete a clinical trial?” The entire list will be available at www.priorityresearch.ie. Conclusion The Top 10 list can inform the direction of future research on trial methods and be used by funders to guide projects aiming to address and improve retention in randomised trials.