Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
10484836 | Value in Health | 2015 | 8 Pages |
Abstract
We propose an a priori responder definition derived from an empirical criterion according to the Food and Drug Administration guidance: a reduction of six points or more in the RSI score at week 12. This preliminary estimate provides a clinically meaningful change at an individual level, although additional studies and validations across various languages are required.
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Authors
Han-Chung MD, MPH, Chen-Chi MD, Shou-Wu MD, Jeng-Yuan MD, Hong-Zen MD, Chung-Wang MD, Chi-Sen MD, PhD, Wen-Miin PhD,