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Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations.

Publication ,  Journal Article
Dworkin, RH; Turk, DC; Wyrwich, KW; Beaton, D; Cleeland, CS; Farrar, JT; Haythornthwaite, JA; Jensen, MP; Kerns, RD; Ader, DN; Brandenburg, N ...
Published in: J Pain
February 2008

UNLABELLED: 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.

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Published In

J Pain

DOI

ISSN

1526-5900

Publication Date

February 2008

Volume

9

Issue

2

Start / End Page

105 / 121

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Research Design
  • Pain Measurement
  • Pain Management
  • Humans
  • Clinical Trials as Topic
  • Anesthesiology
  • 17 Psychology and Cognitive Sciences
  • 11 Medical and Health Sciences
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Dworkin, R. H., Turk, D. C., Wyrwich, K. W., Beaton, D., Cleeland, C. S., Farrar, J. T., … Zavisic, S. (2008). Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain, 9(2), 105–121. https://doi.org/10.1016/j.jpain.2007.09.005
Dworkin, Robert H., Dennis C. Turk, Kathleen W. Wyrwich, Dorcas Beaton, Charles S. Cleeland, John T. Farrar, Jennifer A. Haythornthwaite, et al. “Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations.J Pain 9, no. 2 (February 2008): 105–21. https://doi.org/10.1016/j.jpain.2007.09.005.
Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, et al. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008 Feb;9(2):105–21.
Dworkin, Robert H., et al. “Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations.J Pain, vol. 9, no. 2, Feb. 2008, pp. 105–21. Pubmed, doi:10.1016/j.jpain.2007.09.005.
Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, Haythornthwaite JA, Jensen MP, Kerns RD, Ader DN, Brandenburg N, Burke LB, Cella D, Chandler J, Cowan P, Dimitrova R, Dionne R, Hertz S, Jadad AR, Katz NP, Kehlet H, Kramer LD, Manning DC, McCormick C, McDermott MP, McQuay HJ, Patel S, Porter L, Quessy S, Rappaport BA, Rauschkolb C, Revicki DA, Rothman M, Schmader KE, Stacey BR, Stauffer JW, von Stein T, White RE, Witter J, Zavisic S. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008 Feb;9(2):105–121.
Journal cover image

Published In

J Pain

DOI

ISSN

1526-5900

Publication Date

February 2008

Volume

9

Issue

2

Start / End Page

105 / 121

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Research Design
  • Pain Measurement
  • Pain Management
  • Humans
  • Clinical Trials as Topic
  • Anesthesiology
  • 17 Psychology and Cognitive Sciences
  • 11 Medical and Health Sciences