Interpretation of chronic pain clinical trial outcomes: IMMPACT recommended considerations

  • Shannon M. Smith
    Department of Anesthesiology and Perioperative Medicine, University of Rochester Medical Center, Rochester, NY, United States
  • Robert H. Dworkin
    Department of Anesthesiology and Perioperative Medicine, University of Rochester Medical Center, Rochester, NY, United States
  • Dennis C. Turk
    Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, United States
  • Michael P. McDermott
    Department of Neurology, University of Rochester Medical Center, Rochester, NY, United States
  • Christopher Eccleston
    Centre for Pain Research, The University of Bath, Bath, United Kingdom
  • John T. Farrar
    Departments of Epidemiology, Neurology, and Anesthesia, University of Pennsylvania, Philadelphia, PA, United States
  • Michael C. Rowbotham
    CPMC Research Institute, Sutter Health, San Francisco, CA, United States
  • Zubin Bhagwagar
    Department of Psychiatry, Yale School of Medicine, New Haven, CT, United States
  • Laurie B. Burke
    School of Pharmacy, University of Maryland, Baltimore, MD, United States
  • Penney Cowan
    American Chronic Pain Association, Rocklin, CA, United States
  • Susan S. Ellenberg
    Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA, United States
  • Scott R. Evans
    Department of Epidemiology and Biostatistics, The George Washington University, Washington, DC, United States
  • Roy L. Freeman
    Department of Neurology, Harvard Medical School, Boston, MA, United States
  • Louis P. Garrison
    Department of Pharmacy, University of Washington, Seattle, WA, United States
  • Smriti Iyengar
    Eli Lilly and Company, Indianapolis, IN, United States
  • Alejandro Jadad
    Department of Anesthesia, Faculty of Medicine, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada
  • Mark P. Jensen
    Department of Rehabilitation Medicine, University of Washington, Seattle, WA, United States
  • Roderick Junor
    Eisai Ltd, Hatfield, United Kingdom
  • Cornelia Kamp
    Center for Health and Technology, University of Rochester Medical Center, Rochester, NY, United States
  • Nathaniel P. Katz
    Tufts University School of Medicine, Boston, MA, United States
  • James Patrick Kesslak
    Revance Therapeutics, Newark, CA, United States
  • Ernest A. Kopecky
    Collegium Pharmaceutical, Inc, Stoughton, MA, United States
  • Dmitri Lissin
    Scilex Pharmaceuticals, Palo Alto, CA, United States
  • John D. Markman
    Neuromedicine Pain Management and Translational Pain Research, University of Rochester School of Medicine and Dentistry, Rochester, NY, United States
  • Philip J. Mease
    Rheumatology Clinical Research, Swedish Medical Center, Seattle, WA, United States
  • Alec B. O'Connor
    Department of Medicine, University of Rochester Medical Center, Rochester, NY, United States
  • Kushang V. Patel
    Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, United States
  • Srinivasa N. Raja
    Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, United States
  • Cristina Sampaio
    Faculdade Medicinda de Lisboa, Universidade de Lisboa, Lisboa, Portugal
  • David Schoenfeld
    Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, United States
  • Jasvinder Singh
    Departments of Medicine and Epidemiology, University of Alabama at Birmingham School of Medicine, Birmingham, AB, United States
  • Ilona Steigerwald
    Neumentum, Inc, Palo Alto, CA, United States
  • Vibeke Strand
    Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, United States
  • Leslie A. Tive
    Pfizer, Inc, New York, NY, United States
  • Jeffrey Tobias
    Aquila Consulting Group, LLC, Petaluma, CA, United States
  • Ajay D. Wasan
    Departments of Anesthesiology and Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA, United States
  • 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

  • Pain

    Pain 161 (11), 2446-2461, 2020-06-08

    Ovid Technologies (Wolters Kluwer Health)

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