This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 62
Type: Topic Contributed
Date/Time: Sunday, August 1, 2010 : 4:00 PM to 5:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #307358
Title: Statistical Characterization of QT Prolongation
Author(s): Robert Schall*+
Companies: University of the Free State
Address: , Bloemfontein, International, 9301, South Africa
Keywords: ECG ; heart rate correction ; QT interval ; thorough QT study ; Torsades de pointes ; Bazett
Abstract:

As a general framework for the assessment of QT prolongation we propose that an assessment of "uncorrected" QT prolongation is carried out through a between-treatment comparison of marginal distributions of QT data; assessment of "heart rate corrected" QT prolongation is carried out through a comparison of conditional distributions of QT data (conditional on RR interval). Conditional QT prolongation is, in general, a function of RR interval, and we discuss summary characteristics for that function. We show how current methods for the assessment of QT prolongation relate to the general approach, and to each other. Only the "one-step procedure" can provide a complete characterization of conditional QT prolongation. The "two-step procedure" provides an unbiased estimate of expected conditional QT prolongation, which may be a satisfactory characteristic. Fixed correction should be abandoned.


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