Recommendations for the development, implementation, and reporting of control interventions in efficacy and mechanistic trials of physical, psychological, and self-management therapies: the CoPPS Statement
File(s)Manuscript R2 style formatted_CLEAN_V2.docx (1.17 MB)
Accepted version
Author(s)
Type
Journal Article
Abstract
Control interventions (often called “sham,” “placebo,” or “attention controls”) are essential for studying the efficacy or mechanism of physical, psychological, and self-management interventions in clinical trials. This article presents core recommendations for designing, conducting, and reporting control interventions to establish a quality standard in non-pharmacological intervention research. A framework of additional considerations supports researchers’ decision making in this context. We also provide a reporting checklist for control interventions to enhance research transparency, usefulness, and rigour.
Date Issued
2023-05-25
Date Acceptance
2023-04-05
Citation
BMJ: British Medical Journal, 2023, 381, pp.1-16
ISSN
0959-535X
Publisher
BMJ Publishing Group
Start Page
1
End Page
16
Journal / Book Title
BMJ: British Medical Journal
Volume
381
Copyright Statement
© 2023, BMJ Publishing Group Ltd. This article has been accepted for publication in the BMJ following peer review, and the Version of Record can be accessed online https://www.bmj.com/content/381/bmj-2022-072108
Identifier
http://dx.doi.org/10.1136/bmj-2022-072108
Publication Status
Published
Article Number
ARTN e072108
Date Publish Online
2023-05-25