title: Disregarding clinical trial-based patient-reported outcomes is unwarranted: Five advances to substantiate the scientific stringency of quality-of-life measurement.
abstract: BACKGROUND
  The clinical impact of trial-based quality of life (QL) outcomes is frequently underestimated due, in part, to prejudice and lack of knowledge by the medical community. The objectives of this paper are to show that QL assessments build upon an empirically based and stringent approach to measurement and QL outcomes should not be viewed nor handled differently than any other parameter in medical research.
  
  
  METHODS
  Literature overview.
  
  
  RESULTS
  The objectives are substantiated with empirical evidence showing that: (1) existing QL measures are as reliable as most other clinical outcomes; (2) available guidelines improve the quality of trial-based QL data; (3) QL data have strong prognostic value for survival; (4) clinical significance of QL data can be established; and (5) accounting for response-shift effects in QL data over time is feasible. Finally, the investigation of the genetic disposition of QL is described as an emerging area of research.
  
  
  CONCLUSIONS
  It is a waste of effort and money and also unethical when collected trial-based QL data are not used to their full power. QL and other patient-reported outcomes deserve to be included in more trials, with full disclosure of all results, and standardized interpretation. Only the combined use of patient-reported and clinical outcomes will enable the examination of the extent to which cancer patients live a qualitatively good life as long as possible.
authors.affiliation: Department of Medical Psychology, Academic Medical Center, University of Amsterdam, Amsterdam, Amsterdam, The Netherlands. m.a.sprangers@amc.uva.nl
authors.forename: Mirjam A G
authors.initials: MA
authors.lastname: Sprangers
mesh_terms: D002986:Clinical Trials as Topic; D017408:Guidelines as Topic; D006801:Humans; D009369:Neoplasms / Q000628:therapy*; D011379:Prognosis; D011788:Quality of Life; D016896:Treatment Outcome