Core outcome measures for chronic pain clinical trials: IMMPACT recommendations

No abstract

Aim

IMMPACT-II was convened to develop consensus recommendations for specific measures of each of the IMMPACT core outcome domains.

The objective of the present article is to present consensus recommendations for specific measures of each of the IMMPACT core outcome domains.

Contributors

Dworkin, R. H. Turk, D. C. Farrar, J. T. Haythornthwaite, J. A. Jensen, M. P. Katz, N. P. Kerns, R. D. Stucki, G. Allen, R. R. Bellamy, N. Carr, D. B. Chandler, J. Cowan, P. Dionne, R. Galer, B. S. Hertz, S. Jadad, A. R. Kramer, L. D. Manning, D. C. Martin, S. McCormick, C. G. McDermott, M. P. McGrath, P. Quessy, S. Rappaport, B. A. Robbins, W. Robinson, J. P. Rothman, M. Royal, M. A. Simon, L. Stauffer, J. W. Stein, W. Tollett, J. Wernicke, J. Witter, J.

Publication

Journal: Pain
Volume: 113
Issue: 1-2
Pages: 9 - 19
Year: 2005
DOI: 10.1016/j.pain.2004.09.012

Further Study Information

Current Stage: Not Applicable
Date: April 2003
Funding source(s): None stated


Health Area

Disease Category: Anaesthesia & pain control

Disease Name: Pain (chronic)

Target Population

Age Range: 18 - 100

Sex: Either

Nature of Intervention: Not specified

Stakeholders Involved

- Academic research representatives
- Governmental agencies
- Patient/ support group representatives
- Pharmaceutical industry representatives

Study Type

- Recommendations for outcome measures (measurement/how)

Method(s)

- Consensus meeting
- Literature review

The participants were selected on the basis of their research, clinical, or administrative expertise relevant to the design and evaluation of chronic pain treatment outcomes. Literature reviews of measures of the IMMPACT core outcome domains were commissioned specifically for the IMMPACT-II meeting and distributed to participants prior to the meeting. These reviews focused on measures that could be used in trials of all chronic pain conditions and did not examine measures that were specific to certain types of chronic pain. These background literature reviews and the slide presentations delivered at the meeting are available on the IMMPACT-II page at www.immpact.org/meetings.html. They should be consulted for detailed reviews and discussions of the measures that were considered, the evidence on which the present recommendations are based, and the reasons for selection or rejection of specific measures.

Among the criteria used in evaluating potential core outcome measures were:
(1) appropriateness of the measure’s content and conceptual model;
(2) reliability;
(3) validity;
(4) responsiveness;
(5) interpretability;
(6)precision of scores;
(7) respondent and administrator acceptability;
(8) respondent and administrator burden and feasibility;
(9) availability and equivalence of alternate forms and methods of administration (e.g. self-report, interviewer); and
(10) availability and equivalence of versions for different cultures and languages