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.
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 language | English |
|---|---|
| Pages (from-to) | 49-58 |
| Number of pages | 10 |
| Journal | Journal of Clinical Epidemiology |
| Volume | 123 |
| Early online date | 27 Mar 2020 |
| DOIs | |
| Publication status | Published - Jul 2020 |
Bibliographical note
AcknowledgmentsThe authors would like to acknowledge the trial participants, Surgeons and Research Nurses for agreeing to be audio-recorded as part of the main trial. Thanks also to Professor Craig Ramsay and Mr Irfan Ahmed the Chief Investigators of the trial. Thanks also to Karen Innes the Trial Manager and Becky Bruce the Data Coordinator for their support of the study.
Ethics approval and consent to participate: This study was approved through the parent trial from NHS North of Scotland Research Ethics Committee (16/NS/0053). Informed consent was obtained from all participants.
Declarations of interest: None.
Role of funding source: KG held a Medical Research Council UK Methodology Fellowship during the delivery of this project (MR/L01193X/1). The Health Services Research Unit, Institute of Applied Health Sciences (University of Aberdeen), is core-funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates. The funders had no involvement in study design, collection, analysis and interpretation of data, reporting or the decision to publish.
Keywords
- Clinical trials
- Retention
- Communication
- Informed consent