title: Health-related quality of life in non-small-cell lung cancer: an update of a systematic review on methodologic issues in randomized controlled trials.
abstract: OBJECTIVE
  This study is an update of a systematic review of health-related quality-of-life (HRQOL) methodology reporting in non-small-cell lung cancer (NSCLC) randomized controlled trials (RCTs). The objective was to evaluate HRQOL methodology reporting over the last decade and its benefit for clinical decision making.
  
  
  METHODS
  A MEDLINE systematic literature review was performed. Eligible RCTs implemented patient-reported HRQOL assessments and regular oncology treatments for newly diagnosed adult patients with NSCLC. Included studies were published in English from August 2002 to July 2010. Two independent reviewers evaluated all included RCTs.
  
  
  RESULTS
  Fifty-three RCTs were assessed. Of the 53 RCTs, 81% reported that there was no significant difference in overall survival (OS). However, 50% of RCTs that were unable to find OS differences reported a significant difference in HRQOL scores. The quality of HRQOL reporting has improved; both reporting of clinically significant differences and statistical testing of HRQOL have improved. A European Organisation for Research and Treatment of Cancer HRQOL questionnaire was used in 57% of the studies. However, reporting of HRQOL hypotheses and rationales for choosing HRQOL instruments were significantly less than before 2002 (P < .05).
  
  
  CONCLUSIONS
  The number of NSCLC RCTs incorporating HRQOL assessments has considerably increased. HRQOL continues to demonstrate its importance in RCTs, especially in those studies in which no OS difference is found. Despite the improved quality of HRQOL methodology reporting, certain aspects remain underrepresented. Our findings suggest need for an international standardization of HRQOL reporting similar to the CONSORT guidelines for clinical findings.
authors.affiliation: Erasmus Medical Centre, Rotterdam, the Netherlands.
authors.forename: Lily
authors.initials: L
authors.lastname: Claassens
authors.forename: Jan
authors.initials: J
authors.lastname: van Meerbeeck
authors.forename: Corneel
authors.initials: C
authors.lastname: Coens
authors.forename: Chantal
authors.initials: C
authors.lastname: Quinten
authors.forename: Irina
authors.initials: I
authors.lastname: Ghislain
authors.forename: Elizabeth K
authors.initials: EK
authors.lastname: Sloan
authors.forename: Xin Shelly
authors.initials: XS
authors.lastname: Wang
authors.forename: Galina
authors.initials: G
authors.lastname: Velikova
authors.forename: Andrew
authors.initials: A
authors.lastname: Bottomley
mesh_terms: D002289:Carcinoma, Non-Small-Cell Lung / Q000523:psychology*; D006304:Health Status; D006801:Humans; D008175:Lung Neoplasms / Q000523:psychology*; D017063:Outcome Assessment, Health Care / Q000592:standards*; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design / Q000592:standards