title: Identifying important outcome domains for chronic pain clinical trials: an IMMPACT survey of people with pain.
abstract: This two-phase study was conducted to identify relevant domains of patient-reported outcomes from the perspective of people who experience chronic pain. In Phase 1, focus groups were conducted to generate a pool of patient outcome-related domains and their components. The results of the focus groups identified 19 aspects of their lives that were significantly impacted by the presence of their symptoms and for which improvements were important criteria they would use in evaluating the effectiveness of any treatment. Phase 2 was conducted to examine the importance and relevance of domains identified from a much larger and diverse sample of people with chronic pain. A survey was developed and posted on the American Chronic Pain Association website. Participants were asked to rate the importance of each item or domain identified by the focus groups on a scale of 0 to10 (i.e., 0="not at all important" and 10="extremely important"). The survey was completed by 959 individuals. The results indicate that all 19 aspects of daily life derived from the focus groups were considered important with a majority of respondents indicating a score of 8 or greater. In addition to pain reduction, the most important aspects were enjoyment of life, emotional well-being, fatigue, weakness, and sleep-related problems. Chronic pain clearly impacts health-related quality of life. The results of the two phases of the study indicate that people with chronic pain consider functioning and well-being as important areas affected by the presence of symptoms and as appropriate targets of treatment. These multiple outcomes should be considered when evaluating the efficacy and effectiveness of chronic pain treatments.
authors.affiliation: University of Washington, Seattle, WA, USA University of Rochester, Rochester, NY, USA United BioSource Corporation, Bethesda, MD, USA United States Food and Drug Administration, Rockville, MD, USA Northwestern University, Chicago, IL, USA MD Anderson Cancer Center, Houston, TX, USA American Chronic Pain Association, Rocklin, CA, USA University of Pennsylvania, Philadelphia, PA, USA National Institute of Dental and Craniofacial Research, National Institutes of Health, Department of Health and Human Services, Bethesda, MD, USA.
authors.forename: Dennis C
authors.initials: DC
authors.lastname: Turk
authors.forename: Robert H
authors.initials: RH
authors.lastname: Dworkin
authors.forename: Dennis
authors.initials: D
authors.lastname: Revicki
authors.forename: Gale
authors.initials: G
authors.lastname: Harding
authors.forename: Laurie B
authors.initials: LB
authors.lastname: Burke
authors.forename: David
authors.initials: D
authors.lastname: Cella
authors.forename: Charles S
authors.initials: CS
authors.lastname: Cleeland
authors.forename: Penney
authors.initials: P
authors.lastname: Cowan
authors.forename: John T
authors.initials: JT
authors.lastname: Farrar
authors.forename: Sharon
authors.initials: S
authors.lastname: Hertz
authors.forename: Mitchell B
authors.initials: MB
authors.lastname: Max
authors.forename: Bob A
authors.initials: BA
authors.lastname: Rappaport
mesh_terms: D000203:Activities of Daily Living / Q000523:psychology; D000328:Adult; D002908:Chronic Disease / Q000523:psychology / Q000628:therapy; D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards*; D004185:Disability Evaluation; D005260:Female; D017144:Focus Groups / Q000379:methods; D019538:Health Care Surveys / Q000379:methods*; D006801:Humans; D008297:Male; D008603:Mental Health / Q000706:statistics & numerical data; D008875:Middle Aged; D017063:Outcome Assessment, Health Care / Q000379:methods*; D010147:Pain Measurement / Q000379:methods*; D010148:Intractable Pain / Q000523:psychology* / Q000628:therapy; D017060:Patient Satisfaction; D011788:Quality of Life / Q000523:psychology*; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D016896:Treatment Outcome