Abstract
Background: Recruitment and retention of participants in surgical trials is challenging. Knowledge of the most common and problematic issues will aid future trial design. This study aimed to identify trial staff perspectives on the main issues affecting participant recruitment and retention in UK surgical trials.
Methods: An online survey of UK surgical trial staff was performed. Respondents were asked whether or not they had experienced a range of recruitment and retention issues, and, if yes, how relatively problematic these were (no, mild, moderate or serious problem).
Results: The survey was completed by 155 respondents including 60 trial managers, 53 research nurses, 20 trial methodologists and 19 chief investigators. The three most common recruitment issues were: patients preferring one treatment over another (81.5 per cent of respondents); clinicians' time constraints (78.1 per cent); and clinicians preferring one treatment over another (76.8 per cent). Seven recruitment issues were rated moderate or serious problems by a majority of respondents, the most problematic being a lack of eligible patients (60.3 per cent). The three most common retention issues were: participants forgetting to return questionnaires (81.4 per cent); participants found to be ineligible for the trial (74.3 per cent); and long follow-up period (70.7 per cent). The most problematic retention issues, rated moderate or serious by the majority of respondents, were participants forgetting to return questionnaires (56.4 per cent) and insufficient research nurse time/funding (53.6 per cent).
Conclusion: The survey identified a variety of common recruitment and retention issues, several of which were rated moderate or serious problems by the majority of participating UK surgical trial staff. Mitigation of these problems may help boost recruitment and retention in surgical trials.
| Original language | English |
|---|---|
| Pages (from-to) | 1238–1245 |
| Number of pages | 8 |
| Journal | BJS Open |
| Volume | 4 |
| Issue number | 6 |
| Early online date | 4 Oct 2020 |
| DOIs | |
| Publication status | Published - Dec 2020 |
Bibliographical note
Source of FundingThis research was supported by the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC) (NIHR-BRC-1215-20008) and by the Medical Research Council (MRC) Network of Hubs for Trials Methodology Research (MR/L004933/1-N66), as part of the wider PIRRIST project. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. The Health Services Research Unit, University of Aberdeen, receives core funding from the Chief Scientist Office of the Scottish Government Health Directorates. The funders had no input into the study design, data collection, analysis, interpretation or manuscript writing.
ACKNOWLEDGEMENTS
We are grateful to all survey respondents and to PIRRIST study collaborators and advisers who helped to promote survey. We thank Caroline Jordan and Liz Woolliams for providing administrative support; Rebecca Harmston for providing valuable advice from a patient perspective; Murat Akkulak at the Royal College of Surgeons for providing the RCS portfolio of surgical trials; Amadea Turk for helping to identify potential participants; and colleagues who kindly piloted and helped to improve the survey including Kerry Avery, Karen Barnett, Helen Bulbeck, Marloes Franssen, Nicola Higgins, Jennifer Hirst, Lynne Maddocks, Peter McCulloch, James Shepperd, Jean Simmonds and Sharon Tonner. Anonymised survey data can be made available on request. Please contact the corresponding author. This study was not preregistered. The authors declare no potential competing interests.
Keywords
- RANDOMIZED CONTROLLED-TRIALS