JSM 2005 - Toronto

Abstract #304094

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Legend: = Applied Session, = Theme Session, = Presenter
Activity Number: 439
Type: Topic Contributed
Date/Time: Wednesday, August 10, 2005 : 2:00 PM to 3:50 PM
Sponsor: Section on Statistics in Epidemiology
Abstract - #304094
Title: Sample Size and Study Design Considerations for Method Comparison Studies Based on Regression Analyses
Author(s): Estelle Russek-Cohen*+ and Marina Kondratovich
Companies: U.S. Food and Drug Administration and U.S. Food and Drug Administration
Address: 1350 Piccard Drive, Rockville, MD, 20850, United States
Keywords: Method Comparisons ; Design ; Diagnostic devices
Abstract:

Several methods have been proposed to calculate a regression to compare two methods for the same chemical or analyte. When the analyte in question has a wide reference range (set of potential values), it is plausible to assume the structure of the error may vary over regions. We propose looking at regression methods where the variance is constant over lower values of the analyte but variance goes up with the magnitude of the analyte when the true values are larger. The change point for switching from one error structure to the other is estimated from the data. We compare our methods with other previously proposed methods for estimating the regression line. In addition, because the error variance is not constant, this may suggest alternative sample size strategies, including repeatedly analyzing some samples more often than others.

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Revised March 2005