Interpretation of chronic pain clinical trial outcomes: IMMPACT recommended considerations
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- Shannon M. Smith
- Department of Anesthesiology and Perioperative Medicine, University of Rochester Medical Center, Rochester, NY, United States
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- Robert H. Dworkin
- Department of Anesthesiology and Perioperative Medicine, University of Rochester Medical Center, Rochester, NY, United States
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- Dennis C. Turk
- Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, United States
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- Michael P. McDermott
- Department of Neurology, University of Rochester Medical Center, Rochester, NY, United States
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- Christopher Eccleston
- Centre for Pain Research, The University of Bath, Bath, United Kingdom
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- John T. Farrar
- Departments of Epidemiology, Neurology, and Anesthesia, University of Pennsylvania, Philadelphia, PA, United States
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- Michael C. Rowbotham
- CPMC Research Institute, Sutter Health, San Francisco, CA, United States
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- Zubin Bhagwagar
- Department of Psychiatry, Yale School of Medicine, New Haven, CT, United States
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- Laurie B. Burke
- School of Pharmacy, University of Maryland, Baltimore, MD, United States
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- Penney Cowan
- American Chronic Pain Association, Rocklin, CA, United States
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- Susan S. Ellenberg
- Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA, United States
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- Scott R. Evans
- Department of Epidemiology and Biostatistics, The George Washington University, Washington, DC, United States
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- Roy L. Freeman
- Department of Neurology, Harvard Medical School, Boston, MA, United States
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- Louis P. Garrison
- Department of Pharmacy, University of Washington, Seattle, WA, United States
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- Smriti Iyengar
- Eli Lilly and Company, Indianapolis, IN, United States
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- Alejandro Jadad
- Department of Anesthesia, Faculty of Medicine, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada
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- Mark P. Jensen
- Department of Rehabilitation Medicine, University of Washington, Seattle, WA, United States
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- Roderick Junor
- Eisai Ltd, Hatfield, United Kingdom
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- Cornelia Kamp
- Center for Health and Technology, University of Rochester Medical Center, Rochester, NY, United States
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- Nathaniel P. Katz
- Tufts University School of Medicine, Boston, MA, United States
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- James Patrick Kesslak
- Revance Therapeutics, Newark, CA, United States
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- Ernest A. Kopecky
- Collegium Pharmaceutical, Inc, Stoughton, MA, United States
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- Dmitri Lissin
- Scilex Pharmaceuticals, Palo Alto, CA, United States
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- John D. Markman
- Neuromedicine Pain Management and Translational Pain Research, University of Rochester School of Medicine and Dentistry, Rochester, NY, United States
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- Philip J. Mease
- Rheumatology Clinical Research, Swedish Medical Center, Seattle, WA, United States
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- Alec B. O'Connor
- Department of Medicine, University of Rochester Medical Center, Rochester, NY, United States
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- Kushang V. Patel
- Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, United States
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- Srinivasa N. Raja
- Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, United States
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- Cristina Sampaio
- Faculdade Medicinda de Lisboa, Universidade de Lisboa, Lisboa, Portugal
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- David Schoenfeld
- Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, United States
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- Jasvinder Singh
- Departments of Medicine and Epidemiology, University of Alabama at Birmingham School of Medicine, Birmingham, AB, United States
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- Ilona Steigerwald
- Neumentum, Inc, Palo Alto, CA, United States
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- Vibeke Strand
- Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, United States
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- Leslie A. Tive
- Pfizer, Inc, New York, NY, United States
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- Jeffrey Tobias
- Aquila Consulting Group, LLC, Petaluma, CA, United States
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- Ajay D. Wasan
- Departments of Anesthesiology and Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA, United States
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- Hilary D. Wilson
- Boehringer Ingelheim, Seattle, WA, United States
抄録
<jats:title>Abstract</jats:title> <jats:p>Interpreting randomized clinical trials (RCTs) is crucial to making decisions regarding the use of analgesic treatments in clinical practice. In this article, we report on an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) consensus meeting organized by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks, the purpose of which was to recommend approaches that facilitate interpretation of analgesic RCTs. We review issues to consider when drawing conclusions from RCTs, as well as common methods for reporting RCT results and the limitations of each method. These issues include the type of trial, study design, statistical analysis methods, magnitude of the estimated beneficial and harmful effects and associated precision, availability of alternative treatments and their benefit–risk profile, clinical importance of the change from baseline both within and between groups, presentation of the outcome data, and the limitations of the approaches used.</jats:p>
収録刊行物
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- Pain
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Pain 161 (11), 2446-2461, 2020-06-08
Ovid Technologies (Wolters Kluwer Health)