Methods for Assessing Clinical Significance in Quality of Life Measurement

• Activity Number: 14
• Type: Topic Contributed
• Date/Time: Sunday, August 3, 2003 : 2:00 PM to 3:50 PM
• Sponsor: Biometrics Section
• Author(s): Jeff A. Sloan*+ and Joseph C. Cappelleri*+ and Charles B. Scott*+
• Companies: Mayo Clinic and Pfizer Gobal R&D and American College of Radiology
• Keywords: quality of life ; clinical significance ; oncology ; longitudinal data ; clinical trials

Abstract

The integration of quality of life (QOL) assessment is increasingly a routine part of oncology clinical research. The unmet challenge for the statistical research community is to tell when a clinically significant change in QOL has been achieved. This session will focus on statistical analysis of QOL measures in terms of clinically significant effects. Six papers on this topic recently appeared in the literature produced by thirty international experts on QOL assessment, specifically, methods used to date for clinical significance, group versus individual clinical significance differences, single item versus summated scale scores, patient versus clinician versus population perspectives of clinical significance, assessing changes over time, incorporating clinical significance into clinical practice/industry. Each speaker will present synopses for two of the six manuscript topics. A precis will also be given of a second series of manuscripts prepared for a meeting in Scottsdale, Arizona, October 2-4, 2003. The work is vital to the statistical community, as it is typically the statistician who is ultimately responsible for the design and analysis of a clinical trial's QOL components.