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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

Permanent link
https://hdl.handle.net/10037/32904
DOI
https://doi.org/10.1136/bmj-2022-072108
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Accepted manuscript version (PDF)
Date
2023-05-25
Type
Journal article
Tidsskriftartikkel
Peer reviewed

Author
Hohenschurz-Schmidt, David; Vase, Lene; Scott, Whitney; Annoni, Marco; Ajayi, Oluwafemi K; Barth, Jürgen; Bennell, Kim; Berna, Chantal; Bialosky, Joel; Braithwaite, Felicity; Finnerup, Nanna B.; de C Williams, Amanda C; carlino, elisa; Ceritelli, Francesco; Chaibi, Aleksander; Cherkin, Dan; Colloca, Luana; Cote, Pierre; Darnall, Beth D; Evans, Roni; Fabre, Laurent; Faria, Vanda; French, Simon D; Gerger, Heike; Häuser, Winfried; Hinman, Rana S.; Ho, Dien; Janssens, Thomas; Jensen, Karin; Johnston, Chris; Juhl Lunde, Sigrid; Keefe, Francis; Kerns, Robert D; Koechlin, Helen; Kongsted, Alice; Michener, Lori A; Moerman, Daniel E; Musial, Frauke; Newell, David; Nicholas, Michael; Palermo, Tonya M; Palermo, Sara; Peerdeman, Kaya J.; Pogatzky-Zahn, Esther M; Puhl, Aaron A; Roberts, Lisa; Rossettini, Giacomo; Tomczak Matthiesen, Susan; Underwood, Martin; Vaucher, Paul; Vollert, Jan; Wartolowska, Karolina; Weimer, Katja; Werner, Christoph Patrick; Rice, Andrew S C; Draper-Rodi, Jerry
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.
Publisher
BMJ Publishing Group
Citation
Hohenschurz-Schmidt D, Vase L, Scott W, Annoni M, Ajayi, Barth J, Bennell K, Berna C, Bialosky J, Braithwaite F, Finnerup NB, de C Williams, carlino e, Ceritelli, Chaibi A, Cherkin D, Colloca L, Cote, Darnall, Evans R, Fabre L, Faria V, French SD, Gerger H, Häuser W, Hinman RS, Ho D, Janssens T, Jensen K, Johnston C, Juhl Lunde S, Keefe F, Kerns RD, Koechlin H, Kongsted A, Michener, Moerman, Musial F, Newell D, Nicholas M, Palermo, Palermo S, Peerdeman KJ, Pogatzky-Zahn, Puhl, Roberts L, Rossettini G, Tomczak Matthiesen S, Underwood M, Vaucher P, Vollert J, Wartolowska K, Weimer K, Werner CP, Rice ASC, Draper-Rodi J. 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. The BMJ. 2023;381
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