Pamela Tunji-Ajayi1, Eilidh M Duncan1, Katie Gillies2. 1. Health Services Research Unit, University of Aberdeen, Aberdeen, AB25 2ZD, UK. 2. Health Services Research Unit, University of Aberdeen, Aberdeen, AB25 2ZD, UK. Electronic address: k.gillies@abdn.ac.uk.
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.
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.
Authors: Van Thu Nguyen; Philippe Ravaud; Viet Thi Tran; Bridget Young; Isabelle Boutron Journal: J Med Internet Res Date: 2022-02-01 Impact factor: 5.428
Authors: Anna Kearney; Polly-Anna Ashford; Laura Butlin; Thomas Conway; William J Cragg; Declan Devane; Heidi Gardner; Daisy M Gaunt; Katie Gillies; Nicola L Harman; Andrew Hunter; Athene J Lane; Catherine McWilliams; Louise Murphy; Carrie O'Nions; Edward N Stanhope; Akke Vellinga; Paula R Williamson; Carrol Gamble Journal: Clin Trials Date: 2021-10-24 Impact factor: 2.599