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.
Turk
Dennis C
DC
Department of Anesthesiology, University of Washington, Seattle, Washington, USA. turkdc@u.washington.edu
Dworkin
Robert H
RH
D002908:Chronic Disease; D002986:Clinical Trials as Topic / Q000639:trends*; D026241:Exercise Movement Techniques; D006801:Humans; D007398:Interpersonal Relations; D010146:Pain / Q000523:psychology; D059408:Pain Management; D017060:Patient Satisfaction; D016896:Treatment Outcome