Core outcome domains for chronic pain clinical trials: IMMPACT recommendations

Turk, D. C., Dworkin, R. H., Allen, R. R., Bellamy, N., Brandenburg, N., Carr, D. B., Cleeland, C., Dionne, R., Farrar, J. T., Galer, B. S., Hewitt, D. J., Jadad, A. R., Katz, N. P., Kramer, L. D., Manning, D. C., McCormick, C. G., McDermott, M. P., McGrath, P., Quessy, S., Rappaport, B. A., Robinson, J. P., Royal, M. A., Simon, L., Stauffer, J. W., Stein, W., Tollett, J. and Witter, J. (2003) Core outcome domains for chronic pain clinical trials: IMMPACT recommendations. Pain, 106 3: 337-345. doi:10.1016/j.pain.2003.08.001

Author Turk, D. C.
Dworkin, R. H.
Allen, R. R.
Bellamy, N.
Brandenburg, N.
Carr, D. B.
Cleeland, C.
Dionne, R.
Farrar, J. T.
Galer, B. S.
Hewitt, D. J.
Jadad, A. R.
Katz, N. P.
Kramer, L. D.
Manning, D. C.
McCormick, C. G.
McDermott, M. P.
McGrath, P.
Quessy, S.
Rappaport, B. A.
Robinson, J. P.
Royal, M. A.
Simon, L.
Stauffer, J. W.
Stein, W.
Tollett, J.
Witter, J.
Title Core outcome domains for chronic pain clinical trials: IMMPACT recommendations
Journal name Pain   Check publisher's open access policy
ISSN 0304-3959
Publication date 2003-01-01
Sub-type Article (original research)
DOI 10.1016/j.pain.2003.08.001
Open Access Status Not yet assessed
Volume 106
Issue 3
Start page 337
End page 345
Total pages 9
Editor A. I. Basbaum
Place of publication Amsterdam
Publisher Elsevier BV
Language eng
Subject C1
321028 Rheumatology and Arthritis
730306 Evaluation of health outcomes
Abstract Objective. To provide recommendations for the core outcome domains that should be considered by investigators conducting clinical trials of the efficacy and effectiveness of treatments for chronic pain. Development of a core set of outcome domains would facilitate comparison and pooling of data, encourage more complete reporting of outcomes, simplify the preparation and review of research proposals and manuscripts, and allow clinicians to make informed decisions regarding the risks and benefits of treatment. Methods. Under the auspices of the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT), 27 specialists from academia. governmental agencies, and the pharmaceutical industry participated in a consensus meeting and identified core outcome domains that should be considered in clinical trials of treatments for chronic pain. Conclusions. There was a consensus that chronic pain clinical trials should assess outcomes representing six core domains: (1) pain, (2) physical functioning, (3) emotional functioning, (4) participant ratings of improvement and satisfaction with treatment, (5) symptoms and adverse events, (6) participant disposition (e.g. adherence to the treatment regimen and reasons for premature withdrawal from the trial). Although consideration should be given to the assessment of each of these domains, there may be exceptions to the general recommendation to include all of these domains in chronic pain trials. When this occurs, the rationale for not including domains should be provided. It is not the intention of these recommendations that assessment of the core domains should be considered a requirement for approval of product applications by regulatory agencies or that a treatment must demonstrate statistically significant effects for all of the relevant core domains to establish evidence of its efficacy. (C) 2003 International Association for the Study of Pain.
Keyword Anesthesiology
Clinical Neurology
Chronic Pain
Clinical Trials
Quality Of Life
Physical Functioning
Emotional Functioning
Adverse Events
Global Ratings
Consort Statement
Q-Index Code C1
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Excellence in Research Australia (ERA) - Collection
2004 Higher Education Research Data Collection
School of Medicine Publications
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Citation counts: TR Web of Science Citation Count  Cited 549 times in Thomson Reuters Web of Science Article | Citations
Scopus Citation Count Cited 603 times in Scopus Article | Citations
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Created: Wed, 15 Aug 2007, 05:22:06 EST