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

Pamela Tunji-Ajayi, Eilidh M. Duncan, Kate Gillies*

*Corresponding author for this work

Research output: Contribution to journalArticle

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.
Original languageEnglish
Pages (from-to)49-58
Number of pages10
JournalJournal of Clinical Epidemiology
Volume123
Early online date27 Mar 2020
DOIs
Publication statusPublished - Jul 2020

Keywords

  • Clinical trials
  • Retention
  • Communication
  • Informed consent

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