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
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 c...
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| Hauptverfasser: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
25 May 2023
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| In: |
The BMJ
Year: 2023, Jahrgang: 381, Pages: 1-16 |
| ISSN: | 1756-1833 |
| DOI: | 10.1136/bmj-2022-072108 |
| Online-Zugang: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1136/bmj-2022-072108 Verlag, lizenzpflichtig, Volltext: https://www.bmj.com/content/381/bmj-2022-072108 
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| Verfasserangaben: | David Hohenschurz-Schmidt, Lene Vase, Whitney Scott, Marco Annoni, Oluwafemi K. Ajayi, Jürgen Barth, Kim 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 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 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 |
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| 245 | 1 | 0 | |a Recommendations for the development, implementation, and reporting of control interventions in efficacy and mechanistic trials of physical, psychological, and self-management therapies |b the CoPPS Statement |c David Hohenschurz-Schmidt, Lene Vase, Whitney Scott, Marco Annoni, Oluwafemi K. Ajayi, Jürgen Barth, Kim 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 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 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 |
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| 520 | |a 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. | ||
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