Giovanazzi, Alexia, Jones, Katherine orcid.org/0000-0003-0615-8442, Carr, Rachel Margaret orcid.org/0000-0001-6972-0100 et al. (3 more authors) (2022) Current practice in the measurement and interpretation of intervention adherence in randomised controlled trials:A systematic review. Contemporary Clinical Trials. 106788. ISSN 1551-7144
Abstract
Background Ideally all participants in a randomised controlled trial (RCT) should fully receive their allocated intervention; however, this rarely occurs in practice. Intervention adherence affects Type II error so influences the interpretation of trial results and subsequent implementation. We aimed to describe current practice in the definition, measurement, and reporting of intervention adherence in non-pharmacological RCTs, and how this data is incorporated into a trial's interpretation and conclusions. Methods We conducted a systematic review of phase III RCTs published between January 2018 and June 2020 in the National Institute for Health Research Journals Library for the Health Technology Assessment, Programme Grants for Applied Research, and Public Health Research funding streams. Results Of 237 reports published, 76 met the eligibility criteria and were included. Most RCTs (n = 68, 89.5%) reported adherence, though use of terminology varied widely; nearly three quarters of these (n = 49, 72.1%) conducted a sensitivity analysis. Adherence measures varied between intervention types: behavioural change (n = 10, 43.5%), psychological therapy (n = 5, 83.3%) and physiotherapy/rehabilitation (n = 8, 66.7%) interventions predominately measured adherence based on session attendance. Whereas medical device and surgical interventions (n = 17, 73.9%) primarily record the number of participants receiving the allocated intervention, a third (n = 33, 67.3%) of studies reported a difference in findings between primary and sensitivity analyses. Conclusions Although most trials report elements of adherence, terminology was inconsistent, and there was no systematic approach to its measurement, analyses, interpretation, or reporting. Given the importance of adherence within clinical trials, there is a pressing need for a standardised approach or framework.
Metadata
Item Type: | Article |
---|---|
Authors/Creators: |
|
Copyright, Publisher and Additional Information: | © 2022 Published by Elsevier Inc |
Dates: |
|
Institution: | The University of York |
Academic Units: | The University of York > Faculty of Sciences (York) > Health Sciences (York) |
Depositing User: | Pure (York) |
Date Deposited: | 09 Jun 2022 11:10 |
Last Modified: | 06 Nov 2024 01:48 |
Published Version: | https://doi.org/10.1016/j.cct.2022.106788 |
Status: | Published |
Refereed: | Yes |
Identification Number: | 10.1016/j.cct.2022.106788 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:187829 |
Download
Filename: 1_s2.0_S1551714422001148_main.pdf
Description: Current practice in the measurement and interpretation of intervention adherence in randomised controlled trials: A systematic review
Licence: CC-BY 2.5