Table of Contents
FDA - ODAC Quality of Life Subcommittee
PPT Slide
Why is defining “clinical significance” difficult?
What Clinical significance is NOT
General Classification for Methods Assessing Clinical Significance
Meaningful Change in Group Comparison
Meaningful Change in Individual Measurement
Clinical Interpretability
Proposal: A Unified Theory Approach
Is a Unified Approach Achievable / Simplistic?
Discussion
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Author: Rochester
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