Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations
Autor: | Charles S. Cleeland, Robert D. Kerns, Kathleen W. Wyrwich, Stojan Zavisic, Richard E. White, Linda Porter, David Cella, Dennis C. Turk, Nathaniel P. Katz, Dorcas E. Beaton, Rozalina Dimitrova, Joseph W. Stauffer, Deborah N. Ader, Mark P. Jensen, Nancy A. Brandenburg, Bob A. Rappaport, Cynthia McCormick, Lynn D. Kramer, Raymond A. Dionne, Brett R. Stacey, Donald C. Manning, Michael P. McDermott, Christine Rauschkolb, John T. Farrar, James Witter, Margaret Rothman, Thorsten von Stein, Robert H. Dworkin, Sanjay Patel, Steve Quessy, Kenneth E. Schmader, Dennis A. Revicki, Julie Chandler, Laurie B. Burke, Henry J McQuay, Jennifer A. Haythornthwaite, Sharon Hertz, Alejandro R. Jadad, Penny Cowan, Henrik Kehlet |
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Rok vydání: | 2007 |
Předmět: |
Research design
medicine.medical_specialty Clinical Trials as Topic business.industry Beck Depression Inventory Chronic pain medicine.disease law.invention Clinical trial Anesthesiology and Pain Medicine Quality of life (healthcare) Treatment Outcome Neurology Randomized controlled trial Pain assessment law Research Design Physical therapy Medicine Humans Pain Management Neurology (clinical) Brief Pain Inventory business Pain Measurement |
Zdroj: | University of Copenhagen |
ISSN: | 1526-5900 |
Popis: | 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. |
Databáze: | OpenAIRE |
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