Abstract
Objectives: Pre-trial acceptability studies may boost recruitment, especially in trials comparing distinctly different interventions. We evaluated the impact of an acceptability study on recruitment to a randomised trial of antipsychotic
reduction versus maintenance treatment and explored demographic and clinical predictors of subsequent enrolment.
Methods: Participants with a diagnosis of a schizophrenia spectrum disorder who were taking antipsychotic medication were interviewed about their views of taking part in a future trial.
Results: In a sample of 210 participants, 151 (71.9%) expressed an interest in taking part in the future trial, 16 (7.6%) said they might be interested, and 43 (20.5%) said they were not. Altruistic reasons were most commonly given for
wanting to take part, and concern about randomisation for not wanting to. Ultimately 57 people enrolled in the trial (27.1% of the original sample). Eighty-five people who initially expressed an interest did not enrol due to declining or not being eligible (for clinical reasons). Women and people from a white ethnic background were more likely to enrol in the trial, but no illness or treatment-related characteristics were associated with enrolment.
Conclusion: An acceptability study can be a useful tool for recruitment to challenging trials, but it may over-estimate recruitment.
reduction versus maintenance treatment and explored demographic and clinical predictors of subsequent enrolment.
Methods: Participants with a diagnosis of a schizophrenia spectrum disorder who were taking antipsychotic medication were interviewed about their views of taking part in a future trial.
Results: In a sample of 210 participants, 151 (71.9%) expressed an interest in taking part in the future trial, 16 (7.6%) said they might be interested, and 43 (20.5%) said they were not. Altruistic reasons were most commonly given for
wanting to take part, and concern about randomisation for not wanting to. Ultimately 57 people enrolled in the trial (27.1% of the original sample). Eighty-five people who initially expressed an interest did not enrol due to declining or not being eligible (for clinical reasons). Women and people from a white ethnic background were more likely to enrol in the trial, but no illness or treatment-related characteristics were associated with enrolment.
Conclusion: An acceptability study can be a useful tool for recruitment to challenging trials, but it may over-estimate recruitment.
Original language | English |
---|---|
Article number | 78 |
Number of pages | 8 |
Journal | BMC Medical Research Methodology |
Volume | 23 |
Issue number | 1 |
Early online date | 29 Mar 2023 |
DOIs | |
Publication status | E-pub ahead of print - 29 Mar 2023 |
Bibliographical note
Funding Information:Thank you to North East London NHS Foundation Trust for sponsoring this research.
Funding Information:
This study was conducted as part of research funded by the National Institute for Health and care Research (NIHR); grant number RP-PG-0514-20004. The funder had no role in the design and conduct of the study; collection, management, analysis and interpretation of the data; preparation of the manuscript.
Publisher Copyright:
© 2023, The Author(s).
Keywords
- Randomised Controlled Trials
- Psychotic disorders
- Schizophrenia
- Acceptability
- Recruitment
- RCT