Recruitment to a trial of antipsychotic reduction: impact of an acceptability study

Georgina Ramsay, Zoë Haime, Nadia E Crellin, Joanna Moncrieff*

*Corresponding author for this work

Research output: Contribution to journalArticle (Academic Journal)peer-review

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.
Original languageEnglish
Article number78
Number of pages8
JournalBMC Medical Research Methodology
Volume23
Issue number1
Early online date29 Mar 2023
DOIs
Publication statusE-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

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