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
BMJ, vol. 381, pp. e072108
Abstract
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.
Authors 54
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University College of Osteopathy · Imperial College London
Affiliation as printed
Pain Research, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK
Research Department, University College of Osteopathy, London, UK
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Affiliation as printed
Department of Psychology and Behavioural Sciences, School of Business and Social Sciences, Aarhus University, Denmark
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St Thomas' Hospital · King's College London · Guy's and St Thomas' NHS Foundation Trust
Affiliation as printed
Health Psychology Section, Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King’s College London; INPUT Pain Management Unit, Guy’s and St Thomas’ NHS Foundation Trust, London, UK
Health Psychology Section, Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London
INPUT Pain Management Unit, Guy's and St Thomas' NHS Foundation Trust, London, UK
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Affiliation as printed
Italian National Research Council, Interdepartmental Centre for Research Ethics and Integrity, Rome, Italy
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Affiliation as printed
Department of Arts and Music, College of Human Sciences, University of South Africa, Pretoria, South Africa
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University of Zurich · University Hospital Zurich
Affiliation as printed
Institute for Complementary and Integrative Medicine, University Hospital Zurich and University of Zurich, Switzerland
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Affiliation as printed
Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, University of Melbourne, VIC, Australia
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Centre Hospitalier Universitaire Vaudois · University of Lausanne
Affiliation as printed
Centrer for Integrative and Complementary Medicine, Pain Center, Division of Anesthesiology, Sense Institute, Lausanne University Hospital, Lausanne University, Lausanne, Switzerland
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University of Florida Health · University of Florida
Affiliation as printed
Department of Physical Therapy, University of Florida, Gainesville FL, USA; Brooks-PHHP Research Collaboration, Jacksonville, FL, USA
Brooks-PHHP Research Collaboration, Jacksonville, FL, USA
Department of Physical Therapy, University of Florida, Gainesville FL, USA
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Affiliation as printed
IIMPACT in Health, University of South Australia, Adelaide, SA, Australia
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Aarhus University · Danish Pain Research Center
Affiliation as printed
Danish Pain Research Centre, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark
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Affiliation as printed
Research Department of Clinical, Educational & Health Psychology, University College London, London, UK
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Affiliation as printed
Department of Neuroscience Rita Levi Montalcini, University of Turin, Turin, Italy
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Affiliation as printed
Foundation COME Collaboration, University of Chieti-Pescara, Italy
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Affiliation as printed
Department for Interdisciplinary Health Sciences, Institute of Health and Society, Faculty of Medicine, University of Oslo, Oslo, Norway
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Affiliation as printed
Osher Center for Integrative Health, Department of Family Medicine, University of Washington, Seattle, WA, USA
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University of Maryland, Baltimore
Affiliation as printed
Department of Pain and Translational Symptom Science, School of Nursing; Department of Anesthesiology, School of Medicine; University of Maryland, Baltimore, MD, USA
Department of Anesthesiology, School of Medicine
Department of Pain and Translational Symptom Science, School of Nursing
University of Maryland, Baltimore, MD, USA
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Affiliation as printed
Faculty of Health Sciences, Institute for Disability and Rehabilitation Research, Ontario Tech University, Oshawa, ON, Canada
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Stanford Medicine · Stanford University
Affiliation as printed
Stanford Pain Relief Innovations Lab; Stanford University School of Medicine, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford, CA, USA
Stanford Pain Relief Innovations Lab
Stanford University School of Medicine, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford, CA, USA
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Affiliation as printed
Integrative Health & Wellbeing Research Program; Center for Spirituality and Healing, University of Minnesota, Minneapolis, MN, USA
Center for Spirituality and Healing, University of Minnesota, Minneapolis, MN, USA
Integrative Health & Wellbeing Research Program
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Uppsala University · Boston Children's Hospital · Harvard University · Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde · Technische Universität Dresden
Affiliation as printed
Department of Psychology, Uppsala University, Uppsala, Sweden; Smell & Taste Clinic, Department of Otorhinolaryngology, TU Dresden, Dresden, Germany; Brain and Eye Pain Imaging Lab, Pain and Affective Neuroscience Center, Boston Children’s Hospital, Harvard Medical School, Boston, MA, USA; Department of Anesthesiology, Critical Care and Pain Medicine, Boston Children’s Hospital, Harvard Medical School, Boston, MA, USA
Brain and Eye Pain Imaging Lab, Pain and Affective Neuroscience Center, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA
Department of Anesthesiology, Critical Care and Pain Medicine, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA
Department of Psychology, Uppsala University, Uppsala, Sweden
Smell & Taste Clinic, Department of Otorhinolaryngology, TU Dresden, Dresden, Germany
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Affiliation as printed
Department of Chiropractic, Faculty of Medicine, Health and Human Sciences, Macquarie University, NSW, Australia
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Erasmus MC · Maastricht University · Care and Public Health Research Institute
Affiliation as printed
Erasmus MC, University Medical Centre Rotterdam, Department of General Practice, Rotterdam, the Netherlands; Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, the Netherlands
Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, the Netherlands
Erasmus MC, University Medical Centre Rotterdam, Department of General Practice, Rotterdam, the Netherlands
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Technical University of Munich
Affiliation as printed
Department Psychosomatic Medicine and Psychotherapy, Technische Universität München, Munich, Germany
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Affiliation as printed
Centre for Health, Exercise & Sports Medicine, University of Melbourne, Melbourne, VIC, Australia
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Dien Ho corresponding
Massachusetts College of Pharmacy and Health Sciences
Affiliation as printed
Center for Health Humanities, School of Arts and Sciences, Massachusetts College of Pharmacy and Health Sciences, Boston MA, USA
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Affiliation as printed
Health Psychology, KU Leuven; Ebpracticenet, Leuven, Belgium
Ebpracticenet, Leuven, Belgium
Health Psychology, KU Leuven
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Affiliation as printed
Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
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Affiliation as printed
Department of Psychology and Behavioural Sciences, School of Business and Social Sciences, Aarhus University, Denmark
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Affiliation as printed
Duke University, School of Medicine, Durham, NC, USA
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Affiliation as printed
Departments of Psychiatry, Neurology, and Psychology, Yale University, New Haven, CT, USA
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Boston Children's Hospital · Harvard University · University of Zurich · University Children's Hospital Zurich
Affiliation as printed
Division of Psychosomatics and Psychiatry, University Children’s Hospital Zurich; Division of Child and Adolescent Health Psychology, Department of Psychology, University of Zurich, Zurich, Switzerland; Department of Anesthesiology, Critical Care and Pain Medicine, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA
Department of Anesthesiology, Critical Care and Pain Medicine, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA
Division of Child and Adolescent Health Psychology, Department of Psychology, University of Zurich, Zurich, Switzerland
Division of Psychosomatics and Psychiatry, University Children's Hospital Zurich
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University of Southern Denmark
Affiliation as printed
Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark; Chiropractic Knowledge Hub, Odense, Denmark
Chiropractic Knowledge Hub, Odense, Denmark
Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark
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University of Southern California
Affiliation as printed
Division of Biokinesiology and Physical Therapy, University of Southern California, Los Angeles CA, USA
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University of Michigan–Dearborn
Affiliation as printed
College of Arts, Sciences, and Letters, Behavioral Sciences, University of Michigan, Dearborn, MI, USA
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UiT The Arctic University of Norway
Affiliation as printed
National Research Centre in Complementary and Alternative Medicine, Department of Community Medicine, Faculty of Health Science UiT, Arctic University of Norway, Tromsø, Norway
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Affiliation as printed
AECC University College, Bournemouth, UK
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The University of Sydney · Royal North Shore Hospital
Affiliation as printed
Pain Management Research Institute, University of Sydney Medical School (Northern) and Kolling Institute of Medical Research at Royal North Shore Hospital, Sydney, Australia
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Affiliation as printed
Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA
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Fondazione IRCCS Istituto Neurologico Carlo Besta · University of Turin
Affiliation as printed
Diagnostic and Technology Department, Neuroradiology Unit, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy; Department of Psychology, University of Turin, Turin, Italy
Department of Psychology, University of Turin, Turin, Italy
Diagnostic and Technology Department, Neuroradiology Unit, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy
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Affiliation as printed
Unit Health, Medical and Neuropsychology, Leiden University, Leiden, the Netherlands
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University of Münster · University Hospital Münster
Affiliation as printed
Department of Anaesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany
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Affiliation as printed
Able Body Health Clinic, Lethbridge, AB, Canada
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University Hospital Southampton NHS Foundation Trust · University of Southampton
Affiliation as printed
University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK
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University of Verona · University of Genoa
Affiliation as printed
Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genoa, Campus of Savona, Savona, Italy; School of Physiotherapy, University of Verona, Verona, Italy
Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genoa, Campus of Savona, Savona, Italy
School of Physiotherapy, University of Verona, Verona, Italy
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Affiliation as printed
Department of Psychology and Behavioural Sciences, School of Business and Social Sciences, Aarhus University, Denmark
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University Hospitals Coventry and Warwickshire NHS Trust · University of Warwick
Affiliation as printed
Warwick Clinical Trials Unit; University of Warwick, Coventry, UK; University Hospitals Coventry and Warwickshire, Coventry, UK
University Hospitals Coventry and Warwickshire, Coventry, UK
University of Warwick, Coventry, UK
Warwick Clinical Trials Unit
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HES-SO University of Applied Sciences and Arts Western Switzerland · HES-SO Fribourg
Affiliation as printed
School of Health Sciences Fribourg, HES-SO University of Applied Sciences and Arts Western Switzerland, Switzerland
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Heidelberg University · University of Münster · University Hospital Münster · University Hospital Schleswig-Holstein · Medizinische Fakultät Mannheim · Imperial College London
Affiliation as printed
Pain Research, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK; Division of Neurological Pain Research and Therapy, Department of Neurology, University Hospital of Schleswig-Holstein, Campus Kiel, Germany; Neurophysiology, Mannheim Centre of Translational Neuroscience, Medical Faculty Mannheim, Heidelberg University, Germany; Department of Anaesthesiology, Intensive Care and Pain Medicine, University Hospital Muenster, Germany
Department of Anaesthesiology, Intensive Care and Pain Medicine, University Hospital Muenster, Germany
Division of Neurological Pain Research and Therapy, Department of Neurology, University Hospital of Schleswig-Holstein, Campus Kiel, Germany
Neurophysiology, Mannheim Centre of Translational Neuroscience, Medical Faculty Mannheim, Heidelberg University, Germany
Pain Research, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK
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John Radcliffe Hospital · University of Oxford
Affiliation as printed
Nuffield Department of Clinical Neurosciences, University of Oxford, John Radcliffe Hospital, Oxford, UK
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Affiliation as printed
Department of Psychosomatic Medicine and Psychotherapy, Ulm University Medical Centre, Ulm, Germany
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The University of Sydney · University Hospital of Basel
Affiliation as printed
School of Psychology, Faculty of Science, University of Sydney, Australia; Department of Clinical Research, University Hospital Basel, Switzerland
Department of Clinical Research, University Hospital Basel, Switzerland
School of Psychology, Faculty of Science, University of Sydney, Australia
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Affiliation as printed
Pain Research, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK
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University College of Osteopathy
Affiliation as printed
National Council for Osteopathic Research, London, UK
Research Department, University College of Osteopathy, London, UK
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