Assessment of physical function and participation in chronic pain clinical trials: IMMPACT/OMERACT recommendations
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- Ann M. Taylor
- Centre for Medical Education, School of Medicine, Cardiff University, Cardiff, Wales, United Kingdom
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- Kristine Phillips
- Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA
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- Kushang V. Patel
- Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA
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- Dennis C. Turk
- Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA
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- Robert H. Dworkin
- Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA
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- Dorcas Beaton
- Department of Occupational Science and Occupational Therapy, University of Toronto, ON, Canada
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- Daniel J. Clauw
- Department of Anesthesiology, University of Michigan, Ann Arbor, MI, USA
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- Monique A.M. Gignac
- Institute for Work and Health, University of Toronto, ON, Canada
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- John D. Markman
- Department of Neurology, University of Rochester, Rochester, NY, USA
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- David A. Williams
- Department of Anesthesiology, University of Michigan, Ann Arbor, MI, USA
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- Shay Bujanover
- Depomed, Newark, CA, USA
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- Laurie B. Burke
- LORAGroup LLC, Royal Oak, MD, USA
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- Daniel B. Carr
- Public Health and Community Medicine, Tufts University School of Medicine, Boston, MA, USA
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- Ernest H. Choy
- Division of Infection and Immunity, Cardiff University, Cardiff, Wales, United Kingdom
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- Philip G. Conaghan
- NIHR Leeds Musculoskeletal Biomedical Research Unit, University of Leeds, Leeds, United Kingdom
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- Penney Cowan
- American Chronic Pain Association, Rocklin, CA, USA
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- John T. Farrar
- Department of Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA, USA
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- Roy Freeman
- Department of Neurology, Harvard University, Cambridge, MA, USA
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- Jennifer Gewandter
- Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA
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- Ian Gilron
- Department of Anesthesiology, Queen's University, Ottawa, ON, Canada
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- Veeraindar Goli
- Department of Psychiatry, Duke University Medical Center, Durham, NC, USA
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- Tony D. Gover
- Clinical and Rehabilitative Medicine Research Program, United States Army Medical Research and Materiel Command
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- J. David Haddox
- Purdue Pharma L.P., Stamford, CT, USA
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- Robert D. Kerns
- Department of Veterans Affairs, Veteran Affairs Connecticut Healthcare System, West Haven, CT, USA
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- Ernest A. Kopecky
- Collegium Pharmaceuticals, Inc, Canton, MA, USA
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- David A. Lee
- Chadds Ford, Pennsylvania, PA, USA
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- Richard Malamut
- Teva Pharmaceuticals, North Wales, PA, USA
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- Philip Mease
- Rheumatology Clinic Research Division, Swedish Medical Center, Seattle, WA, USA
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- Bob A. Rappaport
- Analgesic Concepts LLC, Arlington, VA, USA
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- Lee S. Simon
- SDG Consulting LLC, Cambridge, MA, USA
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- Jasvinder A. Singh
- Medical Service, Birmingham Veterans Affairs Medical Center, Birmingham, AL, USA
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- Shannon M. Smith
- Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA
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- Vibeke Strand
- Division of Immunology/Rheumatology, Stanford University School of Medicine, Palo Alto, CA, USA
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- Peter Tugwell
- Faculty of Medicine, the Centre for Global Health, University of Ottawa, Ottawa, ON, Canada
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- Gertrude F. Vanhove
- Jazz Pharmaceuticals, Palo Alto, CA, USA
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- Christin Veasley
- Chronic Pain Research Alliance
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- Gary A. Walco
- Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA
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- Ajay D. Wasan
- Department of Anesthesiology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA
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- James Witter
- National Institutes of Health, Bethesda, MD, USA
抄録
<jats:title>Abstract</jats:title> <jats:p>Although pain reduction is commonly the primary outcome in chronic pain clinical trials, physical functioning is also important. A challenge in designing chronic pain trials to determine efficacy and effectiveness of therapies is obtaining appropriate information about the impact of an intervention on physical function. The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) and Outcome Measures in Rheumatology (OMERACT) convened a meeting to consider assessment of physical functioning and participation in research on chronic pain. The primary purpose of this article is to synthesize evidence on the scope of physical functioning to inform work on refining physical function outcome measurement. We address issues in assessing this broad construct and provide examples of frequently used measures of relevant concepts. Investigators can assess physical functioning using patient-reported outcome (PRO), performance-based, and objective measures of activity. This article aims to provide support for the use of these measures, covering broad aspects of functioning, including work participation, social participation, and caregiver burden, which researchers should consider when designing chronic pain clinical trials. Investigators should consider the inclusion of both PROs and performance-based measures as they provide different but also important complementary information. The development and use of reliable and valid PROs and performance-based measures of physical functioning may expedite development of treatments, and standardization of these measures has the potential to facilitate comparison across studies. We provide recommendations regarding important domains to stimulate research to develop tools that are more robust, address consistency and standardization, and engage patients early in tool development.</jats:p>
収録刊行物
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- Pain
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Pain 157 (9), 1836-1850, 2016-04-07
Ovid Technologies (Wolters Kluwer Health)