title: Quality of life in clinical trials for children.
abstract: OBJECTIVE
  This review is aimed at: discussing the importance of measuring quality of life (QoL) in children, describing the measures actually available for measuring QoL in children, and listing methodological issues related to the inclusion of QoL outcomes in clinical trials.
  
  
  METHODS
  A literature review was carried out. Searches were conducted in Pubmed. All articles published within the last 20 years with the objectives of assessing and reviewing use and issues related to QoL instruments in children were reviewed.
  
  
  RESULTS
  Despite the numerous arguments in favour of assessing QoL, these data are not typically collected in paediatric clinical trials and research protocols. Because adult measures may fail to address the specific aspects of QoL that are important to the child, many different measures, both generic and disease-specific, have been developed to assess QoL in children; however, their quality in terms of psychometric properties often seems questionable. Methodological recommendations are provided for designing a study including QoL outcome.
  
  
  CONCLUSIONS
  This review confirms the importance of measuring QoL in children because of increased survival rates of children with chronic health conditions and because children account for the highest prevalence of disabling conditions. However, measuring QoL in children is still a challenge mainly because of the limitations of the currently available measures. Further research is needed to reach a consensus on the most appropriate formats for child-centred instruments.
authors.affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. annalisa.trama@istitutotumori.mi.it
authors.forename: Annalisa
authors.initials: A
authors.lastname: Trama
authors.forename: Massimiliano
authors.initials: M
authors.lastname: Dieci
mesh_terms: D002648:Child; D002986:Clinical Trials as Topic / Q000379:methods*; D006801:Humans; D010372:Pediatrics / Q000379:methods*; D011788:Quality of Life; D016896:Treatment Outcome