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.
The objective of the IMMPACT meeting was to develop a consensus on outcome domains that would transcend specific chronic pain syndromes. Our goal in this paper is to present the consensus recommendations from the first IMMPACT meeting for a core set of outcome domains that should be considered for all clinical trials of treatments for chronic pain.
ContributorsTurk, 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.
Disease Category: Anaesthesia & pain control
Disease Name: Pain (chronic)
Age Range: 18 - 100
Sex: Either
Nature of Intervention: Any
- Pharmaceutical industry representatives
- Administrative experts
- Clinical experts
- Researchers
- Epidemiologists
- Statisticians
- COS for clinical trials or clinical research
- Consensus meeting
A meeting consisting of 27 people representing academia, governmental agencies, and the pharmaceutical industry was held on November 1–2, 2002. The participants attending the meeting were selected to represent health care disciplines that cover chronic pain broadly defined and included anesthesiology, biostatistics, clinical pharmacology, epidemiology, geriatrics, internal medicine, neurology, nursing, oncology, pediatric pain, physical medicine
and rehabilitation, psychology, and rheumatology; all have research, clinical, or administrative expertise relevant to evaluating chronic pain treatment outcomes. In addition, representatives from the pharmaceutical industry who are engaged in chronic pain clinical trials and an attorney were included to provide specific expertise.
The process of the consensus meeting was semistructured, with the first two authors leading discussions. Prior to the meeting, all participants were provided copies of a recent edited volume on pain assessment (Turk and Melzack, 2001), as well as four published clinical trials that are representative of chronic pain trials. Outcomes included in these studies were used to illustrate the diversity of domains examined in recent trials. The list of various domains generated by the participants was discussed and consensus was reached based on the results of the discussion and a formal vote.