title: Patient-reported outcomes in randomized clinical trials: development of ISOQOL reporting standards.
abstract: OBJECTIVE
  To develop expert consensus on a suite of reporting standards for HRQL outcomes of RCTs.
  
  
  METHODS
  A Task Force of The International Society of Quality of Life Research (ISOQOL) undertook a systematic review of the literature to identify candidate reporting standards for HRQL in RCTs. Subsequently, a web-based survey was circulated to the ISOQOL membership. Respondents were asked to rate candidate standards on a 4-point Likert scale based on their perceived value in reporting studies in which HRQL was a study outcome (primary or secondary). Results were synthesized into draft reporting guidelines, which were further reviewed by the membership to inform the final guidance.
  
  
  RESULTS
  Forty-six existing candidate standards for reporting HRQL results in RCTs were synthesized to produce a 40 item survey that was completed electronically by 161 respondents. The majority of respondents rated all 40 items to be either 'essential' or 'desirable' when HRQL was a primary RCT outcome. Ratings changed when HRQL was a secondary study outcome. Feedback on the survey findings resulted in the Task Force generalizing the guidance to include patient-reported outcomes (PROs). The final guidance, which recommends standards for use in reporting PROs generally, and more specifically, for PROs identified as primary study outcomes, was approved by the ISOQOL Board of Directors.
  
  
  CONCLUSIONS
  ISOQOL has developed a suite of recommended standards for reporting PRO results of RCTs. Improved reporting of PROs will enable accurate interpretation of evidence to inform patient choice, aid clinical decision making, and inform health policy.
authors.affiliation: Queen's University, Kingston, ON, Canada.
authors.forename: Michael
authors.initials: M
authors.lastname: Brundage
authors.forename: Jane
authors.initials: J
authors.lastname: Blazeby
authors.forename: Dennis
authors.initials: D
authors.lastname: Revicki
authors.forename: Brenda
authors.initials: B
authors.lastname: Bass
authors.forename: Henrica
authors.initials: H
authors.lastname: de Vet
authors.forename: Helen
authors.initials: H
authors.lastname: Duffy
authors.forename: Fabio
authors.initials: F
authors.lastname: Efficace
authors.forename: Madeleine
authors.initials: M
authors.lastname: King
authors.forename: Cindy L K
authors.initials: CL
authors.lastname: Lam
authors.forename: David
authors.initials: D
authors.lastname: Moher
authors.forename: Jane
authors.initials: J
authors.lastname: Scott
authors.forename: Jeff
authors.initials: J
authors.lastname: Sloan
authors.forename: Claire
authors.initials: C
authors.lastname: Snyder
authors.forename: Susan
authors.initials: S
authors.lastname: Yount
authors.forename: Melanie
authors.initials: M
authors.lastname: Calvert
mesh_terms: D026683:Advisory Committees; D032921:Consensus; D003245:Consensus Statements as Topic; D003657:Decision Making; D006304:Health Status; D006801:Humans; D017063:Outcome Assessment, Health Care / Q000379:methods / Q000592:standards*; D063868:Patient Outcome Assessment; D011788:Quality of Life / Q000523:psychology*; D016032:Randomized Controlled Trials as Topic / Q000592:standards*