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