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Lessons Learned in the Assessment of Health-Related Quality of Life: Selected Examples From the National Cancer Institute of Canada Clinical Trials Group

Michael Brundage, David Osoba, Andrea Bezjak, Dongsheng Tu, Michael Palmer, Joseph Pater

From the Departments of Oncology and Community Health and Epidemiology, and National Cancer Institute of Canada Clinical Trials Group Queen's Cancer Research Institute, Queens University, Kingston; Department of Radiation Oncology, Princess Margaret Hospital; University Health Network, University of Toronto, Toronto, Ontario; and QOL Consulting, West Vancouver, British Columbia, Canada

Address reprint requests to Michael Brundage, MD, MSc, Cancer Clinic of Southeastern Ontario at Kingston General Hospital, 25 King St W, Kingston, Ontario, Canada, K7L 5P9; e-mail: michael.brundage{at}krcc.on.ca

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.

Supported in part by the National Cancer Institute of Canada.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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