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.

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; Williams, Amanda C de C; Carlino, Elisa; Cerritelli, Francesco; Chaibi, Aleksander; Cherkin, Dan; Colloca, Luana; Côté, Pierre; Darnall, Beth D; Evans, Roni; Fabre, Laurent; Faria, Vanda; French, Simon; 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; Pogatzki-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     «

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; Williams, Amanda C de C; Carlino, Elisa; Cerritelli, Francesco; Chaibi, Aleksander; Cherkin, Dan; Colloca, Luana; Côté, Pierre; Darnall, Beth D; Evans, Roni; Fabre, Laurent; Faria, Vanda; French, Simon; Gerger, Heike; Häuser, Winfried; Hinman, Rana S; Ho, Dien; Janssens, Thomas; Jensen, Karin; Johnston, C...     »

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.     «

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 al...     »