title: Health related quality of life in prostate carcinoma patients: a systematic review of randomized controlled trials.
abstract: BACKGROUND
  Health related quality of life (HRQOL) is increasingly reported as an important endpoint in cancer clinical trials. However, evidence suggests that HRQOL reporting is often inadequate. Given this, the authors undertook a systematic review to evaluate HRQOL assessment methodology and reported outcomes of randomized controlled clinical trials (RCTs) with prostate carcinoma patients.
  
  
  METHODS
  A comprehensive search of the literature from 1980 to 2001, mainly on the following databases, was undertaken: MedLine, Cancerlit, and the Cochrane Controlled Trials Register. Studies were identified according to a predefined coding scheme, including HRQOL measure, cultural validity, compliance data reported and the clinical significance of the results.
  
  
  RESULTS
  Twenty-five RCTs were identified, involving 8015 patients primarily with metastatic cancer. Bicalutamide was the medical treatment against which most treatment comparisons were made. Limitations identified included the fact that only 44% of the studies gave a rationale for selecting a specific HRQOL measure, 64% of the studies failed to report information about the administration of the HRQOL measure, and 56% failed to report compliance at baseline. The measure most often used was the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Care 30 (EORTC QLQ-C30), although some studies used non-validated HRQOL tools.
  
  
  CONCLUSIONS
  The current study revealed a lack of a uniform approach to HRQOL assessment and several methodologic limitations. It is possible that such methodologic limitations have influenced trial findings for HRQOL outcomes.
authors.affiliation: Quality of Life Unit, European Organisation for Research and Treatment of Cancer, 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: George
authors.initials: G
authors.lastname: van Andel
mesh_terms: D006801:Humans; D008297:Male; D011471:Prostatic Neoplasms / Q000628:therapy*; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D018434:Sickness Impact Profile; D016896:Treatment Outcome