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

JOURNAL OF PAIN

卷:9

Review

Dworkin, Robert H.¹  Turk, Dennis C.²  Wyrwich, Kathleen W.³  Beaton, Dorcas⁴  Cleeland, Charles S.⁵  Farrar, John T.⁶  Haythornthwaite, Jennifer A.⁷  Jensen, Mark P.²  Kerns, Robert D.⁸  Ader, Deborah N.⁹  Brandenburg, Nancy¹⁰  Burke, Laurie B.¹¹  Cella, David¹²  Chandler, Julie¹³  Cowan, Penny¹⁴  Dimitrova, Rozalina¹⁵  Dionne, Raymond¹⁶  Hertz, Sharon¹¹  Jadad, Alejandro R.¹⁷  Katz, Nathaniel P.¹⁸  Kehlet, Henrik¹⁹  Kramer, Lynn D.²⁰  Manning, Donald C.²¹  McCormick, Cynthia²²  McDermott, Michael P.²³  McQuay, Henry J.²⁴  Patel, Sanjay²⁵  Porter, Linda²⁶  Quessy, Steve²⁷  Rappaport, Bob A.¹¹  Rauschkolb, Christine²⁸  Revickl, Dennis A.²⁹  Rothman, Margaret²⁸  Schmader, Kenneth E.³⁰  Stacey, Brett R.³¹  Stauffer, Joseph W.³²  Von Stein, Thorsten³³  White, Richard E.³⁴  Witter, James¹¹  Zavislc, Stojan³⁵ 

[1] Univ Rochester, Sch Med & Dent, Dept Anesthesiol, Dept Neurol, Rochester, NY 14627 USA

[2] Univ Washington, Seattle, WA 98195 USA

[3] St Louis Univ, St Louis, MO 63103 USA

[4] Univ Toronto, Inst Work & Hlth, Toronto, ON, Canada

[5] MD Anderson Canc Ctr, Houston, TX USA

[6] Univ Penn, Philadelphia, PA 19104 USA

[7] Johns Hopkins Univ, Baltimore, MD USA

[8] Yale Univ, VA Connecticut Hlthcare Syst, New Haven, CT 06520 USA

[9] NIAMSD, Bethesda, MD USA

[10] Pfizer Inc, New York, NY USA

[11] US FDA, Rockville, MD USA

[12] Northwestern Univ, Evanston Nothwestern Hlthcare, Evanston, IL 60208 USA

[13] Merck & Co Inc, Blue Bell, PA USA

[14] Amer Chron Pain Assoc, Rocklin, CA USA

[15] Allergan Pharmaceut Inc, Irvine, CA USA

[16] NINR, Bethesda, MD USA

[17] Univ Toronto, Univ Hlth Network, Toronto, ON, Canada

[18] Analgesic Res, Needham, MA USA

[19] Univ Copenhagen, Rigshosp, DK-1168 Copenhagen, Denmark

[20] Purdue Pharma, Stamford, CT USA

[21] Celgene Corp, Warren, NJ USA

[22] McCormick Consultat, Bethesda, MD USA

[23] Univ Rochester, Rochester, NY 14627 USA

[24] Univ Oxford, Oxford OX1 2JD, England

[25] Elan Pharmaceut Inc, San Diego, CA USA

[26] NINDS, Bethesda, MD USA

[27] GlaxoSmithKline, Res Triangle Pk, NC USA

[28] Johnson & Johnson, Raritan, NJ USA

[29] United Biosource Corp, Hlth Care Anal Grp, Bethesda, MD USA

[30] Duke Univ, Med Ctr, VA Med ctr, GRECC, Durham, NC USA

[31] Oregon Hlth & Sci Univ, Portland, OR 97201 USA

[32] Alpharma, Elizabeth, NJ USA

[33] Tercica, Brisbane, CA USA

[34] Endo Pharmaceut Inc, Chadds Ford, PA USA

[35] AstraZeneca, Sodertalje, Sweden

关键词: chronic pain;    randomized clinical trials;    outcome measures;    clinical importance;    assessment;    quality of life;    physical functioning;    emotional functioning;    global ratings;   

DOI  :  10.1016/j.jpain.2007.09.005

来源: Elsevier

【 摘 要 】

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. (c) 2008 by the American Pain Society.

【 授权许可】

Free