Core outcome domains for chronic pain clinical trials: IMMPACT recommendations

Dennis C. Turk, Robert H. Dworkin, Robert R. Allen, Nicholas Bellamy, Nancy Brandenburg, Daniel B. Carr, Charles Cleeland, Raymond Dionne, John T. Farrar, Bradley S. Galer, David J. Hewitt, Alejandro R. Jadad, Nathaniel P. Katz, Lynn D. Kramer, Donald C. Manning, Cynthia G. McCormick, Michael P. McDermott, Patrick McGrath, Steve Quessy, Bob A. RappaportJames P. Robinson, Mike A. Royal, Lee Simon, Joseph W. Stauffer, Wendy Stein, Jane Tollett, James Witter

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)337-345
Number of pages9
JournalPain
Volume106
Issue number3
DOIs
StatePublished - Dec 2003

Keywords

  • Adverse events
  • Assessment
  • Chronic pain
  • Clinical trials
  • Emotional functioning
  • Global ratings
  • Outcomes
  • Physical functioning
  • Quality of life

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology
  • Anesthesiology and Pain Medicine

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  • Cite this

    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., ... Witter, J. (2003). Core outcome domains for chronic pain clinical trials: IMMPACT recommendations. Pain, 106(3), 337-345. https://doi.org/10.1016/j.pain.2003.08.001