title: Beyond the development of health-related quality-of-life (HRQOL) measures: a checklist for evaluating HRQOL outcomes in cancer clinical trials--does HRQOL evaluation in prostate cancer research inform clinical decision making?
abstract: OBJECTIVE
  The aim of this study was to evaluate whether the inclusion of health-related quality of life (HRQOL), as a part of the trial design in a randomized controlled trial (RCT) setting, has supported clinical decision making for the planning of future medical treatments in prostate cancer.
  
  
  METHODS
  A minimum standard checklist for evaluating HRQOL outcomes in cancer clinical trials was devised to assess the quality of the HRQOL reporting and to classify the studies on the grounds of their robustness. It comprises 11 key HRQOL issues grouped into four broader sections: conceptual, measurement, methodology, and interpretation. Relevant studies were identified in a number of databases, including MEDLINE and the Cochrane Controlled Trials Register. Both their HRQOL and traditional clinical reported outcomes were systematically analyzed to evaluate their consistency and their relevance for supporting clinical decision making.
  
  
  RESULTS
  Although 54% of the identified studies did not show any differences in traditional clinical end points between treatment arms and 17% showed a difference in overall survival, 74% of the studies showed some difference in terms of HRQOL outcomes. One third of the RCTs provided a comprehensive picture of the whole treatment including HRQOL outcomes to support their conclusions.
  
  
  CONCLUSIONS
  A minimum set of criteria for assessing the reported outcomes in cancer clinical trials is necessary to make informed decisions in clinical practice. Using a checklist developed for this study, it was found that HRQOL is a valuable source of information in RCTs of treatment in metastatic prostate cancer.
authors.affiliation: European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Unit and Genitourinary Unit, EORTC Data Center, Brussels, Belgium. fef@eortc.be
authors.forename: Fabio
authors.initials: F
authors.lastname: Efficace
authors.forename: Andrew
authors.initials: A
authors.lastname: Bottomley
authors.forename: David
authors.initials: D
authors.lastname: Osoba
authors.forename: Carolyn
authors.initials: C
authors.lastname: Gotay
authors.forename: Henning
authors.initials: H
authors.lastname: Flechtner
authors.forename: Sven
authors.initials: S
authors.lastname: D'haese
authors.forename: Alfredo
authors.initials: A
authors.lastname: Zurlo
mesh_terms: D023381:Endpoint Determination; D006304:Health Status; D006801:Humans; D008297:Male; D011471:Prostatic Neoplasms / Q000628:therapy*; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D012107:Research Design