Carlino, Elisa

Colloca, Luana

Palermo, Sara

English

Institutional Research Information System University of Turin

17 October 2023AperTO - Archivio Istituzionale Open Access dell'Università di TorinoOriginal Citation:RECOMMENDATIONS FOR THE DEVELOPMENT, IMPLEMENTATION, AND REPORTING OF (SHAM)CONTROL INTERVENTIONS IN EFFICACY TRIALS OF PHYSICAL, PSYCHOLOGICAL, AND SELF-MANAGEMENT THERAPIES: THE CoPPS STATEMENTPublished version:DOI:10.17605/osf.io/jmyhqTerms of use:Open Access(Article begins on next page)Anyone can freely access the full text of works made available as "Open Access". Works made availableunder a Creative Commons license can be used according to the terms and conditions of said license. Useof all other works requires consent of the right holder (author or publisher) if not exempted from copyrightprotection by the applicable law.Availability:This is the author's manuscriptThis version is available http://hdl.handle.net/2318/1891190 since 2023-02-08T11:58:17ZRECOMMENDATIONS FOR THE DEVELOPMENT,IMPLEMENTATION, AND REPORTING OF (SHAM)CONTROL INTERVENTIONS IN EFFICACY TRIALS OFPHYSICAL, PSYCHOLOGICAL, AND SELF-MANAGEMENT THERAPIES: THE CoPPS STATEMENTThe Society for Back Pain Research (SBPR) Annual General Meeting,‘PANNING FOR GOLD’ 50+ Anniversary Meeting, Coventry, England, 30June – 1 July 2022.FULL ACCESS D Hohenschurz-Schmidt L Vase W Scott M Annoni J BarthK Bennell C Berna Renella J Bialosky F Braithwaite NB FinnerupA C de C Williams E Carlino F Cerritelli A Chaibi D CherkinL Colloca P Côte BD Darnall R Evans L Fabre V FariaS French H Gerger W Häuser RS Hinman D Ho T JanssensK Jensen S Juhl Lunde F Keefe RD Kerns H Koechlin A KongstedLA Michener D Moerman F Musial D Newell M NicholasTM Palermo S Palermo S Pashko KJ Peerdeman EM Pogatzki-ZahnAA Puhl L Roberts G Rossettini C Johnston S Tomczak MatthiesenM Underwood P Vaucher K Wartolowska K Weimer CP WernerASC Rice J Draper-RodiCite thisAbstractBackgroundSpeci cally designed control interventions can account for expectation effects in clinical trials.For the interpretation of ef cacy trials of physical, psychological, and self-managementinterventions for people living with pain, the design, conduct, and reporting of controlinterventions is crucial.ObjectivesTo establish a quality standard in the  eld, core recommendations are presented alongsideadditional considerations and a reporting checklist for control interventions.MethodsThree Delphi rounds with 64 experts in placebo research and/or non-pharmacological clinicaltrials were conducted. The panel was presented with a systematic review and meta-analysis ofcontrol and blinding methods. A draft guidance document included 63 consensus items (≥80%agreement) and was discussed with patient partners. Finally, the draft guidance and results fromstakeholder interviews were discussed at consensus meetings with Delphi participants andpatient representatives.ResultsForty-four experts completed the process. When treatment ef cacy or mechanisms are to bestudied, the advocated principle is to design control interventions as similar as possible to thetested intervention, apart from the components that the study examines. Structured reasoningin the planning phase, early engagement with stakeholders, feasibility work, and piloting willenhance the quality and acceptability of control interventions. With participant blinding being aprimary objective, blinding effectiveness should be routinely assessed and reported.Transparent and detailed reporting will improve interpretability and repeatability of clinicaltrials.ConclusionThis guideline provides the much-needed standards to enhance the quality of ef cacy clinicaltrials in physical, psychological, and self-management intervention research, ultimatelyimproving patient care.Study registration: https://osf.io/jmyhq/Con ict of interest: The authors declare no competing interests.© 2023 - Bone & Joint - Privacy Policy - Terms and Conditions - Refund Policy - AccessibilityStatementSources of Funding: Alain and Sheila Diamond Charitable Trust PhD Studentship.Email: d.hohenschurz-schmidt19@imperial.ac.uk

RECOMMENDATIONS FOR THE DEVELOPMENT, IMPLEMENTATION, AND REPORTING OF (SHAM) CONTROL INTERVENTIONS IN EFFICACY TRIALS OF PHYSICAL, PSYCHOLOGICAL, AND SELF-MANAGEMENT THERAPIES: THE CoPPS STATEMENT

https://iris.unito.it/bitstream/2318/1891190/1/RECOMMENDATIONS%20FOR%20THE%20DEVELOPMENT%2c%20IMPLEMENTATION%2c%20AND%20REPORTING%20OF%20%28SHAM%29%20CONTROL%20INTERVENTIONS%20IN%20EFFICACY%20TRIALS%20OF%20PHYSICAL%2c%20PSYCHOLOGICAL%2c%20AND%20SELF-MANAGEMENT%20THERAPIES_%20THE%20CoPPS%20STATEMENT%20_%20Bone%20%26%20Joint.pdf

RECOMMENDATIONS FOR THE DEVELOPMENT, IMPLEMENTATION, AND REPORTING OF (SHAM) CONTROL INTERVENTIONS IN EFFICACY TRIALS OF PHYSICAL, PSYCHOLOGICAL, AND SELF-MANAGEMENT THERAPIES: THE CoPPS STATEMENT

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