An embedded mixed-methods study highlighted a lack of discussions on retention in clinical trial consultations

Abstract

Objectives: This study investigated trial consultations to identify whether and to what extent discussions of retention are present.

Study design and setting: This embedded mixed-methods study design included a purposive sample of audio-recorded trial consultations obtained from four sites of a large multicenter UK-based surgical RCT. Study participants included potential trial participants, trial surgeons (TSs), and research nurses (RNs).

Results: Forty-four participants were included in this study: potential trial participants (n = 37); TSs (n = 4); and RNs (n = 3). Analysis revealed no discussion of retention across 79% of consultations. Of the remaining 21% where discussions of retention were present, only 3% (maximum) of the conversation related to retention. There was some evidence of good practice, but on the whole the discussions contained inaccuracies about timing and delivery of questionnaires and the right to withdraw often highlighted without providing trial consequences.

Conclusion: This study is the first to explore trial consultations for discussions of retention. It suggests that there may be room for improvement within current practice. Further research is required to determine the generalizability of the findings reported to other clinical trials.

Keywords: Clinical trials; Communication; Informed consent; Retention.