What should be the core outcomes in chronic pain clinical trials?

A consensus conference with representatives from academia, governmental agencies, and the pharmaceutical industry met and concluded that clinical trials designed to assess the efficacy and effectiveness of treatments for chronic pain should consider outcomes in six core domains: pain, physical functioning, emotional functioning, patient global ratings of satisfaction, negative health states and adverse events, and patient disposition. In addition, it was acknowledged that there are many secondary domains that might be of importance and should be included in trials depending on the nature of the treatment and population to whom the treatment is targeted.

Aim

The IMMPACT group meeting focused on the identification of a core set of domains that should be considered in all clinical trials of treatments for chronic pain.

Contributors

Turk, Dennis C. Dworkin, Robert H.

Publication

Journal: Arthritis Research & Therapy
Volume: 6
Issue: 4
Pages: 151 - 4
Year: 2004
DOI: 10.1186/ar1196

Further Study Information

Current Stage: Not Applicable
Date: November 2002
Funding source(s): The IMMPACT meeting was supported by unrestricted educational grants to the University of Rochester Office of Professional Education by Abbott Laboratories, AstraZeneca, Elan Pharmaceuticals, Endo Pharmaceuticals, GlaxoSmithKline, Novartis Pharmaceuticals, Ortho-McNeil Pharmaceuticals, Pfizer, and Purdue Pharma.

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Method(s)

- Consensus meeting

This paper is based on the consensus meeting of the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials
(IMMPACT) held in Annapolis, Maryland, on 1 and 2 November 2002. An extended version of the material summarized in this paper appeared in Pain 2003, 106:337-345.

Linked Studies

• Core outcome set for pediatric chronic pain clinical trials: results from a Delphi poll and consensus meeting
• Core outcome domains for chronic pain clinical trials: IMMPACT recommendations
• Core outcome domains and measures for pediatric acute and chronic/recurrent pain clinical trials: PedIMMPACT recommendations
• Identifying important outcome domains for chronic pain clinical trials: an IMMPACT survey of people with pain
• Core outcome measures for chronic pain clinical trials: IMMPACT recommendations
• Updated recommendations on measures for clinical trials in pediatric chronic pain: a multiphase approach from the Core Outcomes in Pediatric Persistent Pain (Core-OPPP) Workgroup

Related Links

• IMMPACT