Interpreting the Clinical Importance of Treatment Outcomes in Chronic Pain Clinical Trials: IMMPACT Recommendations - 08/08/11
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, Dennis C. Turk †, Kathleen W. Wyrwich ‡, Dorcas Beaton §, Charles S. Cleeland 
, John T. Farrar ¶, Jennifer A. Haythornthwaite #, Mark P. Jensen †, Robert D. Kerns , Deborah N. Ader ††, Nancy Brandenburg ‡‡, Laurie B. Burke §§, David Cella , Julie Chandler ¶¶, Penny Cowan ##, Rozalina Dimitrova , Raymond Dionne †††, Sharon Hertz §§, Alejandro R. Jadad ‡‡‡, Nathaniel P. Katz §§§, Henrik Kehlet , Lynn D. Kramer ¶¶¶, Donald C. Manning ###, Cynthia McCormick , Michael P. McDermott ††††, Henry J. McQuay ‡‡‡‡, Sanjay Patel §§§§, Linda Porter , Steve Quessy ¶¶¶¶, Bob A. Rappaport §§, Christine Rauschkolb ####, Dennis A. Revicki , Margaret Rothman ####, Kenneth E. Schmader †††††, Brett R. Stacey ‡‡‡‡‡, Joseph W. Stauffer §§§§§, Thorsten von Stein , Richard E. White ¶¶¶¶¶, James Witter §§, Stojan Zavisic ##### Departments of Anesthesiology and Neurology, University of Rochester School of Medicine and Dentistry, Rochester, New York. M.D. Anderson Cancer Center, Houston, Texas. VA Connecticut Healthcare System and Yale University, West Haven, Connecticut. Evanston Northwestern Healthcare and Northwestern University, Evanston, Illinois. Allergan, Inc., Irvine, California. Rigshospitalet, Copenhagen University, Copenhagen, Denmark. McCormick Consultation, Bethesda, Maryland. National Institute of Neurological Disorders and Stroke, Bethesda, Maryland. Health Care Analytics Group, United Biosource Corporation, Bethesda, Maryland. Tercica, Brisbane, California. Address reprint requests to Robert H. Dworkin, PhD, University of Rochester School of Medicine and Dentistry, 601 Elmwood Avenue, Box 604, Rochester, NY, 14642.Abstract |
A consensus meeting was convened by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) to provide recommendations for interpreting clinical importance of treatment outcomes in clinical trials of the efficacy and effectiveness of chronic pain treatments. A group of 40 participants from universities, governmental agencies, a patient self-help organization, and the pharmaceutical industry considered methodologic issues and research results relevant to determining the clinical importance of changes in the specific outcome measures previously recommended by IMMPACT for 4 core chronic pain outcome domains: (1) Pain intensity, assessed by a 0 to 10 numerical rating scale; (2) physical functioning, assessed by the Multidimensional Pain Inventory and Brief Pain Inventory interference scales; (3) emotional functioning, assessed by the Beck Depression Inventory and Profile of Mood States; and (4) participant ratings of overall improvement, assessed by the Patient Global Impression of Change scale. It is recommended that 2 or more different methods be used to evaluate the clinical importance of improvement or worsening for chronic pain clinical trial outcome measures. Provisional benchmarks for identifying clinically important changes in specific outcome measures that can be used for outcome studies of treatments for chronic pain are proposed.
Perspective |
Systematically collecting and reporting the recommended information needed to evaluate the clinical importance of treatment outcomes of chronic pain clinical trials will allow additional validation of proposed benchmarks and provide more meaningful comparisons of chronic pain treatments.
Le texte complet de cet article est disponible en PDF.Key words : Chronic pain, randomized clinical trials, outcome measures, clinical importance, assessment, quality of life, physical functioning, emotional functioning, global ratings
Plan
| Supported by unrestricted grants to the University of Rochester Office of Professional Education from Allergan, Alpharma, AstraZeneca, Celgene, Elan, Endo, GlaxoSmithKline, Johnson & Johnson, Merck, NeurogesX, Pfizer, Purdue, and Schwarz Biosciences. |
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| The views expressed in this article are those of the authors. No official endorsement by the US Department of Veterans Affairs, US Food and Drug Administration, US National Institutes of Health, or the pharmaceutical companies that provided unrestricted grants to the University of Rochester Office of Professional Education should be inferred. |
Vol 9 - N° 2
P. 105-121 - février 2008 Retour au numéro
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