JSM 2005 Online Program

Abstract #304644

This is the preliminary program for the 2005 Joint Statistical Meetings in Minneapolis, Minnesota. Currently included in this program is the "technical" program, schedule of invited, topic contributed, regular contributed and poster sessions; Continuing Education courses (August 7-10, 2005); and Committee and Business Meetings. This on-line program will be updated frequently to reflect the most current revisions.

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Activity Number:	309
Type:	Topic Contributed
Date/Time:	Tuesday, August 9, 2005 : 2:00 PM to 3:50 PM
Sponsor:	Biometrics Section
Abstract - #304644
Title:	Assessing Clinical Significance for Quality-of-life Measures
Author(s):	Jeff Sloan*+
Companies:	Mayo Clinic
Address:	200 first st sw, Rochester, MN, 55905, United States
Keywords:	quality of life ; oncology ; measurement error
Abstract:	This presentation attempts to summarize the state of the science regarding efforts to characterize what can be declared a clinically meaningful result for patient-reported outcomes in clinical trials. In recent years, there has been much discussion and controversy surrounding the clinical significance of quality-of-life (QOL) variables as endpoints in clinical trials. Healthy skepticism has been expressed regarding the value added, implementation methods, and analytical approaches of QOL assessments. Discourse among practitioners, psychometricians, and pharmaceutical institutions have focused more on problems instead of solutions. We will describe and delineate some of these solutions in the hopes of facilitating the scientific discourse. The good news is that, despite a myriad of approaches taken to assess the clinical significance of QOL variables, the literature is conveying to an emerging consensus. All that is needed is time and experience with QOL assessments for their clinical significance to be as familiar as other endpoints, such as tumor response and toxicity.

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