title: Quality of life assessment of randomized controlled trials.
abstract: OBJECTIVE
  According to the USA Food and Drug Administration, quality of life (QOL) and/or survival are a priority for new anticancer drug approval. This study was performed to review approaches to QOL in randomized controlled clinical trials (RCCTs) and to survey the use of such measures in trials.
  
  
  METHODS
  A literature survey was carried out using the Medline/Medscape, Embase, Cochrane Library, and Ovid databases. Included in the survey were all publications in the set period (from 1966 to June 2005) with "quality of life" in the title or in the abstract in the field of "randomized, controlled clinical trials". Each trial was evaluated according to the level of importance of QOL as a measure of outcome (primary, important and secondary) and was analyzed using the quality scoring system reported by Nicolucci et al. with some items regarding QOL.
  
  
  RESULTS
  Four hundred and five RCCT articles in the oncology setting were found. Fifty-six of the 405 (13.8%) publications had QOL as primary end point. The overall quality score of these trials ranged from 40% to 100%, with a median overall score of 80%. The overall score was correlated with the year of publication (P = 0.007), the type of journal (P = 0.05), the presence of a biostatistician among the authors (P = 0.001), and the number of participating institutions (P = 0.009).
  
  
  CONCLUSIONS
  More attention to QOL in all components of RCCTs (design, choice of instruments, data management and processing) is required from both clinicians and statisticians.
authors.affiliation: Department of Medical Oncology, Infermi Hospital, Rimini, Italy. ipanzini@auslrn.net
authors.forename: Ilaria
authors.initials: I
authors.lastname: Panzini
authors.forename: Angelo
authors.initials: A
authors.lastname: Fioritti
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Gianni
authors.forename: Davide
authors.initials: D
authors.lastname: Tassinari
authors.forename: Debora
authors.initials: D
authors.lastname: Canuti
authors.forename: Carla
authors.initials: C
authors.lastname: Fabbri
authors.forename: Britt
authors.initials: B
authors.lastname: Rudnas
authors.forename: Franco
authors.initials: F
authors.lastname: Desiderio
authors.forename: Alberto
authors.initials: A
authors.lastname: Ravaioli
mesh_terms: D006801:Humans; D009369:Neoplasms / Q000628:therapy*; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D015203:Reproducibility of Results; D011795:Surveys and Questionnaires