Interpreting the Clinical Importance of Treatment Outcomes in Chronic Pain Clinical Trials: IMMPACT Recommendations

Robert H. Dworkin, 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. KatzHenrik 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

Research output: Contribution to journalReview article

1606 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)105-121
Number of pages17
JournalJournal of Pain
Volume9
Issue number2
DOIs
StatePublished - Feb 1 2008

    Fingerprint

Keywords

  • Chronic pain
  • assessment
  • clinical importance
  • emotional functioning
  • global ratings
  • outcome measures
  • physical functioning
  • quality of life
  • randomized clinical trials

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology
  • Anesthesiology and Pain Medicine

Cite this

Dworkin, R. H., Turk, D. C., Wyrwich, K. W., Beaton, D., Cleeland, C. S., Farrar, J. T., Haythornthwaite, J. A., Jensen, M. P., Kerns, R. D., Ader, D. N., Brandenburg, N., Burke, L. B., Cella, D., Chandler, J., Cowan, P., Dimitrova, R., Dionne, R., Hertz, S., Jadad, A. R., ... Zavisic, S. (2008). Interpreting the Clinical Importance of Treatment Outcomes in Chronic Pain Clinical Trials: IMMPACT Recommendations. Journal of Pain, 9(2), 105-121. https://doi.org/10.1016/j.jpain.2007.09.005