title: Lessons learned in the assessment of health-related quality of life: selected examples from the National Cancer Institute of Canada Clinical Trials Group.
abstract: In this article, we provide a brief historical review of the development of patient-reported outcome measurement, analysis, and reporting in clinical trials of the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG). In doing so, we examine selected lessons learned in furthering the quality of these data and their application to clinical practice. We conclude that sequential institution of key policies within the NCIC CTG and the development of a collective philosophy within the group has enabled the routine incorporation of health-related quality of life into clinical trial protocols according to robust scientific principles; that collection of quality data is possible in a variety of circumstances (although not universally so); that patient-reported data on subjective experiences is likely to be more reliable and valid than conventional toxicity information; and that simple analyses that report group trends as well as individual patient response rates are preferred.
authors.affiliation: Department of Oncology, and National Cancer Institute of Canada Clinical Trials Group Queen's Cancer Research Institute, Queens University, Kingston, Kingston, Ontario, Canada. michael.brundage@krcc.on.ca
authors.forename: Michael
authors.initials: M
authors.lastname: Brundage
authors.forename: David
authors.initials: D
authors.lastname: Osoba
authors.forename: Andrea
authors.initials: A
authors.lastname: Bezjak
authors.forename: Dongsheng
authors.initials: D
authors.lastname: Tu
authors.forename: Michael
authors.initials: M
authors.lastname: Palmer
authors.forename: Joseph
authors.initials: J
authors.lastname: Pater
mesh_terms: D002170:Canada; D002986:Clinical Trials as Topic; D003627:Data Interpretation, Statistical; D003657:Decision Making; D006801:Humans; D009369:Neoplasms / Q000628:therapy*; D017060:Patient Satisfaction; D019984:Quality Indicators, Health Care; D011788:Quality of Life; D018434:Sickness Impact Profile; D016896:Treatment Outcome