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

Autor: Ramsay G; Research and Development, North East London NHS Foundation Trust, Ilford, Essex, UK., Haime Z; University College London, Bloomsbury , UK., Crellin NE; Nuffield Trust, East London, UK., Stansfeld JL; Research and Development, North East London NHS Foundation Trust, Ilford, Essex, UK.; University College London, Bloomsbury , UK., Priebe S; Unit for Social and Community Psychiatry, Queen Mary University of London, Mile End, East London, UK., Long M; Research and Development, North East London NHS Foundation Trust, Ilford, Essex, UK.; University College London, Bloomsbury , UK., Moncrieff J; Research and Development, North East London NHS Foundation Trust, Ilford, Essex, UK. j.moncrieff@ucl.ac.uk.; University College London, Bloomsbury , UK. j.moncrieff@ucl.ac.uk.
Jazyk: angličtina
Zdroj: BMC medical research methodology [BMC Med Res Methodol] 2023 Mar 29; Vol. 23 (1), pp. 78. Date of Electronic Publication: 2023 Mar 29.
DOI: 10.1186/s12874-023-01881-0
Abstrakt: 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.
(© 2023. The Author(s).)
Databáze: MEDLINE
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