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

David Hohenschurz-Schmidt*, Lene Vase, Whitney Scott, Marco Annoni, Oluwafemi Ajayi, Jürgen Barth, Kim L. Bennell, Chantal Berna, Joel Bialosky, Felicity Braithwaite, Nanna B. Finnerup, Amanda C. de C. Williams, Elisa Carlino, Francesco Cerritelli, Aleksander Chaibi, Dan Cherkin, Luana Colloca, Pierre Côté, Beth D. Darnall, Roni EvansLaurent Fabre, Vanda Faria, Simon French, Heike Gerger, Winfried Häuser, Rana S. Hinman, Dien Ho, Thomas Janssens, Karin Jensen, Chris Johnston, Sigrid Juhl Lunde, Francis Keefe, Robert D. Kerns, Helen Koechlin, Alice Kongsted, Lori A. Michener, Daniel E. Moerman, Frauke Musial, David Newell, Michael Nicholas, Tonya M. Palermo, Sara Palermo, Kaya J. Peerdeman, Esther M. Pogatzki-Zahn, Aaron A. Puhl, Lisa Roberts, Giacomo Rossettini, Susan Tomczak Matthiesen, Martin Underwood, Paul Vaucher, Jan Vollert, Karolina Wartolowska, Katja Weimer, Christoph Patrick Werner, Andrew S. C. Rice, Jerry Draper-Rodi

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

15 Citations (Scopus)

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.
Original languageEnglish
Article numbere072108
Pages (from-to)1-16
Number of pages16
JournalBMJ
Volume381
Issue numbere072108
DOIs
Publication statusPublished - 25 May 2023

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