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Activity Number: 500
Type: Contributed
Date/Time: Wednesday, August 12, 2015 : 8:30 AM to 10:20 AM
Sponsor: Section on Medical Devices and Diagnostics
Abstract #315145
Title: Application of Receiver Operating Characteristic Method for Evaluating Optimal Threshold of Echocardiogram Parameters for Prediction of Clinical Outcome in a Medical Device Trial
Author(s): Hong Wang* and Peter Lam
Companies: Boston Scientific and Boston Scientific
Keywords: Logistic Regression ; ROC ; Threshold ; Simulation
Abstract:

Receiver operating characteristic (ROC) curve is widely used in the medical device trials to use surrogate endpoints to predict the clinical outcomes. In this application, the ROC curve is utilized to assess the correlations of the echocardiogram (ECHO) parameters with the clinical outcome of paravalvular regurgitation (PVR) in a heart valve trial. The examined ECHO endpoints will include the annulus, left ventricular outflow track in area, perimeter and the derived ratio with device size. The c-statistics will be computed with its 95% confidence interval for each ECHO parameter. Simulation with varying sample size and event rate will be applied to compare the performance of ROC and p value (0.05) based significance. A threshold from ECHO parameters to predict PVR using the Logistic regression risk function will be explored.


Authors who are presenting talks have a * after their name.

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