title: PROMIS measures of pain, fatigue, negative affect, physical function, and social function demonstrated clinical validity across a range of chronic conditions.
abstract: To present an overview of a series of studies in which the clinical validity of the National Institutes of Health's Patient Reported Outcome Measurement Information System (NIH; PROMIS) measures was evaluated, by domain, across six clinical populations.
  
  
  
  Approximately 1,500 individuals at baseline and 1,300 at follow-up completed PROMIS measures. The analyses reported in this issue were conducted post hoc, pooling data across six previous studies, and accommodating the different designs of the six, within-condition, parent studies. Changes in T-scores, standardized response means, and effect sizes were calculated in each study. When a parent study design allowed, known groups validity was calculated using a linear mixed model.
  
  
  
  The results provide substantial support for the clinical validity of nine PROMIS measures in a range of chronic conditions.
  
  
  
  The cross-condition focus of the analyses provided a unique and multifaceted perspective on how PROMIS measures function in "real-world" clinical settings and provides external anchors that can support comparative effectiveness research. The current body of clinical validity evidence for the nine PROMIS measures indicates the success of NIH PROMIS in developing measures that are effective across a range of chronic conditions.
authors.affiliation: Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, 633 N. St. Clair, 19th Floor, Chicago, IL 60611, USA. Electronic address: karon.cook@northwestern.edu.
authors.forename: Karon F
authors.initials: KF
authors.lastname: Cook
authors.affiliation: Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, 633 N. St. Clair, 19th Floor, Chicago, IL 60611, USA; Department of Surgery (Division of Organ Transplant), Northwestern University Feinberg School of Medicine, 251 E. Huron, Galter 3-150, Chicago, IL, USA.
authors.forename: Sally E
authors.initials: SE
authors.lastname: Jensen
authors.affiliation: Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, 633 N. St. Clair, 19th Floor, Chicago, IL 60611, USA.
authors.forename: Benjamin D
authors.initials: BD
authors.lastname: Schalet
authors.affiliation: Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, 633 N. St. Clair, 19th Floor, Chicago, IL 60611, USA.
authors.forename: Jennifer L
authors.initials: JL
authors.lastname: Beaumont
authors.affiliation: Department of Rehabilitation Medicine, University of Washington School of Medicine, 4907 25th Ave NE, Seattle, WA 98105, USA.
authors.forename: Dagmar
authors.initials: D
authors.lastname: Amtmann
authors.affiliation: National Heart Lung and Blood Institute (NHLBI), Building 31, Room 5A52, 31 Center Drive MSC 2486, Bethesda, MD 20892, USA.
authors.forename: Susan
authors.initials: S
authors.lastname: Czajkowski
authors.affiliation: Division of General Internal Medicine and Cecil G. Sheps Center for Health Services Research, University of North Carolina School of Medicine, CB# 7590, 725 Martin Luther King Jr. Blvd., Chapel Hill, NC 27599-7590, USA.
authors.forename: Darren A
authors.initials: DA
authors.lastname: Dewalt
authors.affiliation: Department of Medicine, Stanford University School of Medicine, 300 Pasteur Dr H3580, Stanford, CA 94305, USA.
authors.forename: James F
authors.initials: JF
authors.lastname: Fries
authors.affiliation: Department of Psychiatry, University of Pittsburgh School of Medicine, 3811 O'Hara Street, Pittsburgh, PA 15213, USA.
authors.forename: Paul A
authors.initials: PA
authors.lastname: Pilkonis
authors.affiliation: Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, CB# 7590, 725 Martin Luther King Jr. Blvd., Chapel Hill, NC 27599-7590, USA.
authors.forename: Bryce B
authors.initials: BB
authors.lastname: Reeve
authors.affiliation: University of Southern California, 635 Downey Way, Los Angeles, CA 9008, USA.
authors.forename: Arthur A
authors.initials: AA
authors.lastname: Stone
authors.affiliation: Department of Psychiatry, Duke University School of Medicine, 2400 Pratt Street, Durham, NC 27705, USA.
authors.forename: Kevin P
authors.initials: KP
authors.lastname: Weinfurt
authors.affiliation: Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, 633 N. St. Clair, 19th Floor, Chicago, IL 60611, USA.
authors.forename: David
authors.initials: D
authors.lastname: Cella
mesh_terms: D000203:Activities of Daily Living; D000293:Adolescent; D000328:Adult; D000339:Affect; D000368:Aged; D002908:Chronic Disease; D059350:Chronic Pain / Q000175:diagnosis* / Q000453:epidemiology / Q000523:psychology; D015897:Comorbidity; D057186:Comparative Effectiveness Research; D005221:Fatigue / Q000175:diagnosis* / Q000453:epidemiology / Q000523:psychology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D009316:National Institutes of Health (U.S.); D010147:Pain Measurement / Q000379:methods / Q000523:psychology / Q000706:statistics & numerical data; D011594:Psychometrics; D015203:Reproducibility of Results; D057566:Self Report; D012919:Social Behavior; D011795:Surveys and Questionnaires / Q000592:standards*; D014481:United States / Q000453:epidemiology; D055815:Young Adult
keywords: Outcomes research; Patient-reported outcomes; Psychometrics; Responsiveness; Validity