文档介绍：Volume 13 • Number 4 • 2010
VALUE IN HEALTH
Quantifying Women’s Stated Benefit–Risk Trade-Off
Preferences for IBS Treatment esvhe_694 418..423
F. Reed Johnson, PhD,1 A. Brett Hauber, PhD,1 Semra Özdemir, MS,2 Larry Lynd, PhD3
1RTI International, Research Triangle Park, NC, USA; 2University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; 3University of British
Columbia,Vancouver, BC, Canada
ABSTRACT
Background: The Food and Drug Administration, currently, is exploring least 18 years of age with a self-reported diagnosis of diarrhea-
quantitative benefit–risk methods to support regulatory decision-making. predominant IBS.
A scientifically valid method for assessing patients’ benefit–risk trade-off Measures: Preference weights and MAR were estimated using mixed-logit
preferences is needed pare risks and benefits in mon metric. methods.
Objectives: The study aims to quantify the maximum acceptable risk Results: Subjects were willing to accept higher risks of serious AEs in
(MAR) of treatment-related adverse events (AEs) that women with return for treatments offering better symptom control. For an improve-
diarrhea-predominant irritable bowel syndrome (IBS) are willing to accept ment from the lowest to the highest of four benefit levels, subjects were
in exchange for symptom relief. willing to tolerate a % increase in impacted-bowel risk, but only a
Methods: R