Developing a measure of participant experience of trials: qualitative study and cognitive testing

Abstract

Background To encourage participation in trials, people need to have a positive experience. However, researchers do not routinely measure participant experience. Our aim is to facilitate routine measurement by developing a measure that captures the participant perspective, in a way that is meaningful, acceptable and useful to trial teams and participants. Methods We conducted a focus group and 25 interviews with trial professionals and trial participants to explore how participant experiences of trials should be measured, and to identify domains and items to include in the measure. Interviewees were also asked to comment on a list of candidate domains and items informed by a previous review of the literature on participant experience measures. Interviews were analysed thematically. Candidate domains and items were incorporated into a draft measure. Cognitive testing was undertaken in two rounds to ensure the items were comprehensible and grounded in participant experience. Results Interviewees and patient and public contributors reported that standardising the measurement of participant experience of trials had the potential to improve trial experience but described issues around the timing of measurement. Cognitive testing highlighted issues with comprehension, recall and response and numerous items were removed or refined. We developed a standard and a short version of the measure for feasibility testing. Conclusions We developed a measure covering important domains of participant experience of trials, which could assist trial teams and participants to improve trial design and enhance delivery of a meaningful participant experience.