Article In Press
Volume 2 Issue 1
Analysis of Sensitivity Index for Assessing Generalizability in Clinical Research
Ying Lu, Yuanyuan Kong*, and Shein-Chung Chow
In clinical research, it is often of interest to determine whether the observed clinical results from the original target patient population (e.g., adults) can be generalized to another similar but different patient population (e.g., pediatrics or elderly). Under certain assumptions, it can be shown that the effect sizes adjusted for standard deviation between two patient populations differs by a factor, which is usually referred to as a sensitivity index. If the confidence interval of the sensitivity index is totally within a pre-specified equivalence limits, then we conclude that the clinical results from the original target patient population can be generalized to the similar but different patient population.