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
- PMID: 37230508
- DOI: 10.1136/bmj-2022-072108
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
Conflict of interest statement
Competing interests: All authors have completed the ICMJE uniform disclosure form at https://www.icmje.org/disclosure-of-interest/ and declare: 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. The following authors declare financial relationships with any organisations that might have an interest in the submitted work in the previous three years: DHS (research grant from The Osteopathic Foundation; royalties from the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials [IMMPACT]; consulting fees from Altern Health Ltd; travel fellowship from Society for Back Pain Research), MA (consulting fees from GLG - Deep Mind, Human Technopole Foundation), FB (John Stuart Colville Fellowship from Arthritis Foundation of South Australia), PC (grants from Canadian Institutes of Health Research, Canadian Chiropractic Research Foundation, Social Sciences and Humanities Research Council of Canada, College of Chiropractors of British Columbia, Canadian Chiropractic Association; payments for expert testimony from Canadian Chiropractic Protective Association and NCMIC), BD (Patient-Centered Outcomes Research Institute [PCORI] #PCS_2021C1_22347, PCORI #1610-3700; stock options in AppliedVR), RE (grants and/or contracts from National Institutes of Health [NIH] and US. Department of Defence), VF (support from Swedish Research Council 437-2014-6767; support to attend meetings and/or travel), NF (support from Innovative Medicines Initiative (IMI) 2 Pain Care - an EU IMI 2 public-private consortium that involves the following companies: Grünenthal, Bayer, Eli Lilly, Esteve, and Teva; consulting fees from Merck, Almirall, NeuroPN, Vertex, Novartis Pharma, Biogen, Merz, and Confo Therapeutics), RSH (NHMRC, Australian Research Council, Medibank), HK (Swiss National Science Foundation, Postdoc.Mobility Fellowship [P400PS_186658/1] and Postdoc.Mobility Return Grant [P5R5PS_203064/1]; project specific research support to affiliated institution by Stiftung für psychosomatische, ganzheitliche Medizin; invited crosstalk on “Chronic pain in children and adolescents: chances and hurdles in clinical practice” at the University of Basel, Faculty of Psychology; invited teaching of a module on “Communication with children and their families in the context of chronic pain,” Bern University of Applied Sciences; travel grant for the 2nd official Society in Placebo Studies conference in Leiden, NL, from the Travel Fund of the University of Basel), LAM (grants or contracts from PAC-12 Student-Athlete Health and Well Being Grant, NIH National Institute of Arthritis and Musculoskeletal and Skin Diseases [NIAMS], American Physical Therapy Association, The Charles D. and Mary A. Bauer Foundation), MN (Department of Health [Australian Government] Grant GO2810 9: Health Professional Pain Management Education and Training Project [2020-2024]; Harper Collins Books royalties for joint authorship of “Manage Your Pain”), FK (support as a co-principal investigator on NIH grant 1U24-NS114416-01 and a co-investigator on a number of NIH grants [1R21-DA052729-01A1, 315-55811085033391-10000116454, 17-112, 5R01-CA193673-05, 5R01-CA202779-05, 5P30-AG064201-02, 2004832463/5UH3-AR077360-03, 239631/1-R01AG064947-01A1, 239631/1-R01AG064947-01A1, 1U24-NS114416-01 (PI), 5R01-CA237892-03, 5R01-CA229425-03, 5R01-NR017801-04, 5UH3-AT009790-05, 5R01-CA249959-03, 577985/U01-DK123813-03, 315-5581108503339/1UG3-NR019196-01, 5113091/5R01-AG058702-04, 359-32491-11000000084/3UG1-CA189824-08S1] and a grant from the American Cancer Society; royalties for a book he co-authored on the self-management of pain; consulting to the Health Innovations Network in London regarding strategies for training physical therapists in teaching coping skills to their patients; honorarium for giving an online lecture on pain to the IMMPACT XXV meeting), TP (NIH research grants; royalties for two books on cognitive-behaviour therapy published with Oxford University Press; consulting fees from Mahana Therapeutics, a digital therapeutics company that made payments for consulting on their cognitive-behaviour therapy product), KJP (Early Career Research Grant from the International Association for the Study of Pain [IASP]; Leiden University Fund research grant), EMP-Z (grants or contracts from the German Research Foundation, the German Federal Ministry of Education and Research, the German Federal Joint Committee, the IMI 2 Joint Undertaking under grant agreement 777500 [the Joint Undertaking receives support from the EU’s Horizon 2020 research and innovation programme and the European Federation of Pharmaceutical Industries and Associations]; payments and honorariums from Grünenthal, Novartis, Medtronic; all money went to affiliated institutions [WWU/UKM]), WS (grants from Medical Research Council and Versus Arthritis MR/W002388/1, National Institute for Health and Care Research PDF2015-08-059), MU has been chief investigator or co-investigator on multiple research projects funded by the NIHR under financial relationships with organisations that might have an interest in the submitted work, PV (grants or contracts from University of Applied Sciences and Arts Western Switzerland, Swiss Osteopathic Science Foundation, Swiss National Fund, CARA; consulting fees from SuisseOsteo for advice to the professional association ethical board; payments and/or honorariums from University of Applied Sciences and Arts Western Switzerland, CIDO, Kookies, SuisseOsteo, SCNJ), CPW (grants from Australian Commonwealth International Research and Training Program; payments or honorariums from The University of Sydney; support for attending meetings and/or travel: World Sleep Conference 2019, Young Investigator Award), JV (consulting fees from Vertex Pharmaceuticals, Embody Orthopaedic, Casquar), ASCR (grants and studentships from UK Research and Innovation [Medical Research Council and Biotechnology and Biological Sciences Research Council], Versus Arthritis, Alan and Sheila Diamond Trust, Royal British Legion, European Commission, Dr Jennie Gwynn Bequests, Royal Society of Medicine; remunerated consultancy work for Imperial College Consultants, including for work for Confo, Pharmnovo, Lateral, Mundipharma, Vertex, Novartis, Orion, Shanghai SIMR Biotech; speaker honorarium for MD Anderson Cancer Center; patents [none being commercialised]: Rice ASC, Vandevoorde S, and Lambert DM. Methods using N-(2-propenyl)hexadecanamide and related amides to relieve pain. WO 2005/079771 and Okuse K et al. Methods of treating pain by inhibition of vgf activity. EP13702262.0/ WO2013 110945; owner of share options in Spinifex Pharmaceuticals from which personal benefit accrued upon the acquisition of Spinifex by Novartis in July 2015 [final payment was made in 2019]). The following authors declare no financial relationships with any organisations that might have an interest in the submitted work in the previous three years: OA, JBa, KB, CB, JBi, EC, FC, AC, DC, LC, JDR, LF, SF, HG, DH, WH, CJ, TJ, KJ, RDK, AK, SJL, STM, DEM, FM, DN, SP, AAP, LR, GR, LV, KWa, KWe, ACDCW. 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.
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