BMJ, pages e072108

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

David Hohenschurz-Schmidt ^{1, 2}

Lene Vase ³

Scott Whitney ⁴

Marco Annoni ⁵

Oluwafemi K Ajayi ⁶

Jürgen Barth ⁷

Kim Bennell ⁸

Chantal Berna ⁹

Joel Bialosky ¹⁰

Felicity Braithwaite ¹¹

Nanna B. Finnerup ¹²

Amanda C de C Williams ¹³

Elisa Carlino ¹⁴

Francesco Cerritelli ¹⁵

Aleksander Chaibi ¹⁶

DAN CHERKIN ¹⁷

Luana Colloca ¹⁸

Pierre Côté ¹⁹

Beth D. Darnall ²⁰

Roni Evans ²¹

Laurent Fabre ²²

Vanda Faria ²³

Simon French ²⁴

Heike Gerger ²⁵

Winfried Häuser ²⁶

RANA S. HINMAN ²⁷

Dien Ho ²⁸

Thomas Janssens ²⁹

Karin Jensen ³⁰

Chris Johnston ³¹

Sigrid Juhl Lunde ³

Francis Keefe ³²

Robert D. Kerns ³³

Helen Koechlin ³⁴

Alice Kongsted ³⁵

Lori A. Michener ³⁶

Daniel E. Moerman ³⁷

Frauke Musial ³⁸

David Newell ³⁹

NICHOLAS MICHAEL ⁴⁰

Tonya M. Palermo ⁴¹

Sara Palermo ⁴²

Kaya J. Peerdeman ⁴³

Esther M. Pogatzki-Zahn ⁴⁴

Aaron A. Puhl ⁴⁵

Lisa Roberts ⁴⁶

Giacomo Rossettini ⁴⁷

Susan Tomczak Matthiesen ³

Martin Underwood ⁴⁸

Paul Vaucher ⁴⁹

Jan Vollert ⁵⁰

Karolina Wartolowska ⁵¹

Katja Weimer ⁵²

Christoph Patrick Werner ⁵³

Andrew S.C. Rice ¹

Jerry Draper-Rodi ^{2, 54}

Show full list: 56 authors

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Pain Research, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK |

Research Department, University College of Osteopathy, London, UK |

Department of Psychology and Behavioural Sciences, School of Business and Social Sciences, Aarhus University, Denmark |

⁴

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 |

⁵

Italian National Research Council, Interdepartmental Centre for Research Ethics and Integrity, Rome, Italy |

⁶

Department of Arts and Music, College of Human Sciences, University of South Africa, Pretoria, South Africa |

⁷

Institute for Complementary and Integrative Medicine, University Hospital Zurich and University of Zurich, Switzerland |

⁸

Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, University of Melbourne, VIC, Australia |

⁹

Centrer for Integrative and Complementary Medicine, Pain Center, Division of Anesthesiology, Sense Institute, Lausanne University Hospital, Lausanne University, Lausanne, Switzerland |

¹⁰

Department of Physical Therapy, University of Florida, Gainesville FL, USA; Brooks-PHHP Research Collaboration, Jacksonville, FL, USA |

¹¹

IIMPACT in Health, University of South Australia, Adelaide, SA, Australia |

¹²

Danish Pain Research Centre, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark |

¹³

Research Department of Clinical, Educational & Health Psychology, University College London, London, UK |

¹⁴

Department of Neuroscience Rita Levi Montalcini, University of Turin, Turin, Italy |

¹⁵

Foundation COME Collaboration, University of Chieti-Pescara, Italy |

¹⁶

Department for Interdisciplinary Health Sciences, Institute of Health and Society, Faculty of Medicine, University of Oslo, Oslo, Norway |

¹⁷

Osher Center for Integrative Health, Department of Family Medicine, University of Washington, Seattle, WA, USA |

¹⁸

Department of Pain and Translational Symptom Science, School of Nursing; Department of Anesthesiology, School of Medicine; University of Maryland, Baltimore, MD, USA |

¹⁹

Faculty of Health Sciences, Institute for Disability and Rehabilitation Research, Ontario Tech University, Oshawa, ON, Canada |

²⁰

Stanford Pain Relief Innovations Lab; Stanford University School of Medicine, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford, CA, USA |

²¹

Integrative Health & Wellbeing Research Program; Center for Spirituality and Healing, University of Minnesota, Minneapolis, MN, USA |

²²

Centre Européen d’Enseignement Supérieur de l’Ostéopathie, Paris, France |

²³

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

²⁴

Department of Chiropractic, Faculty of Medicine, Health and Human Sciences, Macquarie University, NSW, Australia |

²⁵

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

²⁶

Department Psychosomatic Medicine and Psychotherapy, Technische Universität München, Munich, Germany |

²⁷

Centre for Health, Exercise & Sports Medicine, University of Melbourne, Melbourne, VIC, Australia |

²⁸

Center for Health Humanities, School of Arts and Sciences, Massachusetts College of Pharmacy and Health Sciences, Boston MA, USA |

²⁹

Health Psychology, KU Leuven; Ebpracticenet, Leuven, Belgium |

³⁰

Department of clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden |

³¹

BC Patient Safety & Quality Council's Patient Voices Network; Health Research BC's Partnership-Ready Network; Health Standards Organization’s Emergency Management Technical Committee & Working Group

³²

Duke University, School of Medicine, Durham, NC, USA |

³³

Departments of Psychiatry, Neurology, and Psychology, Yale University, New Haven, CT, USA |

³⁴

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

³⁵

Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark; Chiropractic Knowledge Hub, Odense, Denmark |

³⁶

Division of Biokinesiology and Physical Therapy, University of Southern California, Los Angeles CA, USA |

³⁷

College of Arts, Sciences, and Letters, Behavioral Sciences, University of Michigan, Dearborn, MI, USA |

³⁸

National Research Centre in Complementary and Alternative Medicine, Department of Community Medicine, Faculty of Health Science UiT, Arctic University of Norway, Tromsø, Norway |

³⁹

AECC University College, Bournemouth, UK |

⁴⁰

Pain Management Research Institute, University of Sydney Medical School (Northern) and Kolling Institute of Medical Research at Royal North Shore Hospital, Sydney, Australia

⁴¹

Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA |

⁴²

Diagnostic and Technology Department, Neuroradiology Unit, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy; Department of Psychology, University of Turin, Turin, Italy

⁴³

Unit Health, Medical and Neuropsychology, Leiden University, Leiden, the Netherlands |

⁴⁴

Department of Anaesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany |

⁴⁵

Able Body Health Clinic, Lethbridge, AB, Canada |

⁴⁶

University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK |

⁴⁷

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

⁴⁸

Warwick Clinical Trials Unit; University of Warwick, Coventry, UK; University Hospitals Coventry and Warwickshire, Coventry, UK

⁴⁹

School of Health Sciences Fribourg, HES-SO University of Applied Sciences and Arts Western Switzerland, Switzerland |

⁵⁰

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

⁵¹

Nuffield Department of Clinical Neurosciences, University of Oxford, John Radcliffe Hospital, Oxford, UK |

⁵²

Department of Psychosomatic Medicine and Psychotherapy, Ulm University Medical Centre, Ulm, Germany |

⁵³

School of Psychology, Faculty of Science, University of Sydney, Australia; Department of Clinical Research, University Hospital Basel, Switzerland |

⁵⁴

National Council for Osteopathic Research, London, UK |

Publication type: Journal Article

Publication date: 2023-05-25

BMJ

Journal: BMJ

scimago Q1

SJR: 2.803

CiteScore: 19.9

Impact factor: 93.6

ISSN: 09598146, 17561833, 09598138, 14685833, 00071447

DOI: 10.1136/bmj-2022-072108

Copy DOI

General Environmental Science

General Earth and Planetary Sciences

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.

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TY - JOUR

DO - 10.1136/bmj-2022-072108

UR - https://doi.org/10.1136/bmj-2022-072108

TI - 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

T2 - BMJ

AU - Hohenschurz-Schmidt, David

AU - Vase, Lene

AU - Whitney, Scott

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 - MICHAEL, NICHOLAS

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 - Vollert, Jan

AU - Wartolowska, Karolina

AU - Weimer, Katja

AU - Werner, Christoph Patrick

AU - Rice, Andrew S.C.

AU - Draper-Rodi, Jerry

PY - 2023

DA - 2023/05/25

PB - BMJ

SP - e072108

SN - 0959-8146

SN - 1756-1833

SN - 0959-8138

SN - 1468-5833

SN - 0007-1447

ER -

BibTex

Found error?

Publisher

BMJ

Journal

BMJ

scimago Q1

SJR

2.803

CiteScore

19.9

Impact factor

93.6

ISSN

09598146 (Print)

17561833 (Electronic)

09598138 (Print)

14685833 (Electronic)

00071447 (Print)

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

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