title: ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research.
abstract: OBJECTIVE
  An essential aspect of patient-centered outcomes research (PCOR) and comparative effectiveness research (CER) is the integration of patient perspectives and experiences with clinical data to evaluate interventions. Thus, PCOR and CER require capturing patient-reported outcome (PRO) data appropriately to inform research, healthcare delivery, and policy. This initiative's goal was to identify minimum standards for the design and selection of a PRO measure for use in PCOR and CER.
  
  
  METHODS
  We performed a literature review to find existing guidelines for the selection of PRO measures. We also conducted an online survey of the International Society for Quality of Life Research (ISOQOL) membership to solicit input on PRO standards. A standard was designated as "recommended" when >50 % respondents endorsed it as "required as a minimum standard."
  
  
  RESULTS
  The literature review identified 387 articles. Survey response rate was 120 of 506 ISOQOL members. The respondents had an average of 15 years experience in PRO research, and 89 % felt competent or very competent providing feedback. Final recommendations for PRO measure standards included: documentation of the conceptual and measurement model; evidence for reliability, validity (content validity, construct validity, responsiveness); interpretability of scores; quality translation, and acceptable patient and investigator burden.
  
  
  CONCLUSIONS
  The development of these minimum measurement standards is intended to promote the appropriate use of PRO measures to inform PCOR and CER, which in turn can improve the effectiveness and efficiency of healthcare delivery. A next step is to expand these minimum standards to identify best practices for selecting decision-relevant PRO measures.
authors.affiliation: Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, 1101-D McGavran-Greenberg Building, 135 Dauer Drive, CB 7411, Chapel Hill, NC, 27599-7411, USA, bbreeve@email.UNC.edu.
authors.forename: Bryce B
authors.initials: BB
authors.lastname: Reeve
authors.forename: Kathleen W
authors.initials: KW
authors.lastname: Wyrwich
authors.forename: Albert W
authors.initials: AW
authors.lastname: Wu
authors.forename: Galina
authors.initials: G
authors.lastname: Velikova
authors.forename: Caroline B
authors.initials: CB
authors.lastname: Terwee
authors.forename: Claire F
authors.initials: CF
authors.lastname: Snyder
authors.forename: Carolyn
authors.initials: C
authors.lastname: Schwartz
authors.forename: Dennis A
authors.initials: DA
authors.lastname: Revicki
authors.forename: Carol M
authors.initials: CM
authors.lastname: Moinpour
authors.forename: Lori D
authors.initials: LD
authors.lastname: McLeod
authors.forename: Jessica C
authors.initials: JC
authors.lastname: Lyons
authors.forename: William R
authors.initials: WR
authors.lastname: Lenderking
authors.forename: Pamela S
authors.initials: PS
authors.lastname: Hinds
authors.forename: Ron D
authors.initials: RD
authors.lastname: Hays
authors.forename: Joanne
authors.initials: J
authors.lastname: Greenhalgh
authors.forename: Richard
authors.initials: R
authors.lastname: Gershon
authors.forename: David
authors.initials: D
authors.lastname: Feeny
authors.forename: Peter M
authors.initials: PM
authors.lastname: Fayers
authors.forename: David
authors.initials: D
authors.lastname: Cella
authors.forename: Michael
authors.initials: M
authors.lastname: Brundage
authors.forename: Sara
authors.initials: S
authors.lastname: Ahmed
authors.forename: Neil K
authors.initials: NK
authors.lastname: Aaronson
authors.forename: Zeeshan
authors.initials: Z
authors.lastname: Butt
mesh_terms: D057186:Comparative Effectiveness Research / Q000379:methods / Q000592:standards*; D017408:Guidelines as Topic; D006801:Humans; D017063:Outcome Assessment, Health Care / Q000379:methods / Q000592:standards*; D063868:Patient Outcome Assessment; D017060:Patient Satisfaction; D018802:Patient-Centered Care / Q000592:standards*; D011594:Psychometrics; D011788:Quality of Life; D015203:Reproducibility of Results; D012107:Research Design / Q000592:standards; D057566:Self Report / Q000592:standards*; D011795:Surveys and Questionnaires