• Impact of active placebo controls on estimated drug effects in randomised trials: a systematic review of trials with both active placebo and standard placebo 

      Laursen, David RT; Nejstgaard, Camilla Hansen; Bjørkedal, Espen; Dreyer Frost, Anders; Rix Hansen, Morten; Paludan-Müller, Asger S; Prosenz, Julian; Werner, Christoph Patrick; Hrjóbjartsson, Asbjørn (Journal article; Tidsskriftartikkel; Peer reviewed, 2023-03-06)
      Background - An estimated 60% of pharmacological randomised trials use placebo control interventions to blind (i.e. mask) participants. However, standard placebos do not control for perceptible non‐therapeutic effects (i.e. side effects) of the experimental drug, which may unblind participants. Trials rarely use active placebo controls, which contain pharmacological compounds designed to mimic the ...
    • 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.; 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 (Journal article; Tidsskriftartikkel; Peer reviewed, 2023-05-25)
      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 ...