Abstract
| Original language | English |
|---|---|
| Article number | e072108 |
| Number of pages | 16 |
| Journal | BMJ |
| Volume | 381 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - 25 May 2023 |
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In: BMJ, Vol. 381, No. 1, e072108, 25.05.2023.
Research output: Contribution to journal › Article › Academic › peer-review
TY - JOUR
T1 - Recommendations for the development, implementation, and reporting of control interventions in efficacy and mechanistic trials of physical, psychological, and self-management therapies
T2 - the CoPPS Statement
AU - Hohenschurz-Schmidt, David
AU - Vase, Lene
AU - Scott, Whitney
AU - Annoni, Marco
AU - Ajayi, Oluwafemi K.
AU - Barth, Jürgen
AU - Bennell, Kim
AU - Berna, Chantal
AU - Bialosky, Joel
AU - Braithwaite, Felicity
AU - Finnerup, Nanna B.
AU - Williams, Amanda C.De C.
AU - Carlino, Elisa
AU - Cerritelli, Francesco
AU - Chaibi, Aleksander
AU - Cherkin, Dan
AU - Colloca, Luana
AU - Côté, Pierre
AU - Darnall, Beth D.
AU - Evans, Roni
AU - Fabre, Laurent
AU - Faria, Vanda
AU - French, Simon
AU - Gerger, Heike
AU - Häuser, Winfried
AU - Hinman, Rana S.
AU - Ho, Dien
AU - Janssens, Thomas
AU - Jensen, Karin
AU - Johnston, Chris
AU - Juhl Lunde, Sigrid
AU - Keefe, Francis
AU - Kerns, Robert D.
AU - Koechlin, Helen
AU - Kongsted, Alice
AU - Michener, Lori A.
AU - Moerman, Daniel E.
AU - Musial, Frauke
AU - Newell, David
AU - Nicholas, Michael
AU - Palermo, Tonya M.
AU - Palermo, Sara
AU - Peerdeman, Kaya J.
AU - Pogatzki-Zahn, Esther M.
AU - Puhl, Aaron A.
AU - Roberts, Lisa
AU - Rossettini, Giacomo
AU - Tomczak Matthiesen, Susan
AU - Underwood, Martin
AU - Vaucher, Paul
AU - Et al.
N1 - Funding Information: The following authors declare other relationships or activities that could appear to have influenced the submitted work: OA (unpaid leadership or fiduciary roles for Gail Sickle Initiative, Pan Africa Sickle Cell Federation, Rare Disease South Africa, and Global Alliance of Partners for Pain Advocacy Task Force), CB (Swiss Pain Society, board member; European Pain Federation [EFIC], councillor; Swiss Society for Psychosomatic Medicine, scientific advisory board), FB (speaker fees for talks related to pain and blinding; support from Flinders University, the Australian Pain Society, and the South Australian Association of Internal Medicine to support attending meetings and travel), LC (treasurer of Society for Interdisciplinary Placebo Studies), PC (reimbursement of travel expenses to attend meetings from Eurospine and European Chiropractic Union), BD (book royalties for four books; consulting fees from AppliedVR, Chief Science Advisor; travel fees for national and international conferences, travel to International Neuropsychological Society meting in May 2022; participation on a Data Safety Monitoring Board or Advisory Board for NIH grants, Medical Advisory Board of Facial Pain Association; Board of Directors, Institute for Brain Potential; Board of Directors, American Academy of Pain Medicine; Co-Chair of the Behavioural Medicine Committee; NIH Interagency Pain Research Coordinating Committee), RE (leadership or fiduciary role on the National Advisory Council for Complementary and Integrative Health), NF (past chair of Neuropathic Pain Special Interest Group), RSH (Journal of Physiotherapy Editorial Board), LAM (honorariums from Memorial Hermann Hospital, Houston, TX; roles on NIAMS Advisory Board and PCORI Advisory Board; leadership or fiduciary role in American Physical Therapy Association – Academy of Orthopaedic Physical Therapy), MN (honorariums from Taiwan Pain Society; Sydney Medical School, University of Sydney reimbursement of expenses for attending Australian Pain Society conference in Hobart, 2022; member of the executive committee (unpaid) for Agency for Clinic Innovation, NSW Ministry of Health; shares in Commonwealth Bank of Australia and Insurance Australia Group), CJ (patient advocacy for BC Patient Safety and Quality Council's Patient Voices Network; Health Research BC's Partnership-Ready Network; Health Standards Organisation's Emergency Management Technical Committee and Working Group), FK (Duke University, on behalf of FK, holds a patent to an online training program in pain coping skills called PainTRAINER; this online program is free to all - neither Duke University nor FK receives any funds related to this free program), TP (leadership or fiduciary role in Society of Paediatric Psychology), KJP (support for attending meetings and/or travel from Landelijk Netwerk Vrouwelijke Hoogleraren (LNVH) Distinguished Women Scientists Fund), EMP-Z (participation on a Data Safety Monitoring Board or Advisory Board for Grünenthal; council member of IASP, board member (scribe) of the German Pain Society, Chair of the Acute Pain Special Interest Group of the IASP, past chair of the subcommittee Acute and Chronic Pain and Palliative Medicine Pain Management of the European Society of Anaesthesiology and Intensive Care (ESAIC), member of the research committee of ESAIC and member of the European Society of Regional Anaesthesia and Pain Therapy Prospect group, Deputy Editor in Chief for the European Journal of Anaesthesiology), MU (participation on a Data Safety Monitoring Board or Advisory Board for the UK National Institute of Health and Care Research), PV (participation on a Data Safety Monitoring Board or Advisory Board for University College of Osteopathy, Still University, Swiss Osteopathic Science Foundation, Permanence rue du Lac; leadership or fiduciary role in COME and HES-SO domaine santé; receipt of equipment, materials, drugs, medical writing, gifts, or other services from Kookies; other financial or non-financial interests as an independent clinician at OsteoPole), KWe (member of the steering committee of the Society for Interdisciplinary Placebo Studies), ASCR (participation on a Data Safety Monitoring Board or Advisory Board: Medicines and Healthcare Products Regulatory Agency Commission on Human Medicines - Neurology, Pain and Psychiatry Expert Advisory Group; Joint Committee on Vaccine and Immunisation Member - varicella subcommittee; Councillor and President Elect from 9/22 of IASP; executive committee member of Analgesic Clinical Trial Translation: Innovations, Opportunities, and Networks). The following authors declare no other relationships or activities that could appear to have influenced the submitted work: DHS, MA, JBa, KB, JBi, EC, FC, AC, DC, JDR, LF, VF, SF, HG, DH, WH, TJ, KJ, RDK, HK, AK, SJL, STM, DEM, FM, DN, SP, AAP, LR, GR, WS, LV, JV, KWa, CPW, ACDCW. Funding Information: Support for the submitted work was received by the following authors: DHS (Alan and Sheila Diamond Charitable Trust, PhD stipend), BD (National Institute on Drug Abuse DA053564), JDR (Alan and Sheila Diamond Charitable Trust, payment to affiliated institution to develop a PhD studentship), RSH (National Health and Medical Research Council [NHMRC] Senior Research Fellowship), ASCR (Alan and Sheila Diamond Trust). The following authors declare no support from any organisation for the submitted work: OA, MA, JBa, KB, CB, JBi, FB, EC, FC, AC, DC, LC, PC, RE, LF, VF, NF, SF, HG, DH, WH, CJ, TJ, KJ, RDK, HK, AK, FK, SJL, STM, LAM, DEM, FM, MN, DN, SP, TP, KJP, EMP-Z, AAP, LR, GR, WS, MU, LV, PV, JV, KWa, KWe, CPW, ACDCW. Funding Information: Funding and sponsors: This work was supported by a PhD studentship from the Alan and Sheila Diamond Charitable Trust awarded to DHS. Neither this funder nor the funders of any of the authors’ positions had any role in the design, conduct, analysis, or dissemination of this study.
PY - 2023/5/25
Y1 - 2023/5/25
N2 - 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.
AB - 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.
U2 - 10.1136/bmj-2022-072108
DO - 10.1136/bmj-2022-072108
M3 - Article
C2 - 37230508
SN - 1756-1833
VL - 381
JO - BMJ
JF - BMJ
IS - 1
M1 - e072108
ER -