JSM 2004 - Toronto

Abstract #300018

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Activity Number: 318
Type: Invited
Date/Time: Wednesday, August 11, 2004 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #300018
Title: Covariate-adjusted Reference Intervals for Diagnostic Data with Application to Electrocardiographic Data
Author(s): Alexei Dmitrienko*+
Companies: Eli Lilly and Company
Address: Lilly Research Laboratories, Indianapolis, IN, 46285,
Keywords: QT interval ; reference interval ; quantile regression
Abstract:

The analysis of extreme diagnostic measurements--e.g., QTc interval--in clinical trials relies on reference intervals that help drug developers quickly determine whether a particular value is typical or atypical. The distribution of QTc interval is greatly influenced by various covariates such as patient's age, and it is important to properly account for this influence in the analysis of extreme QTc values. This presentation discusses several approaches to constructing covariate-adjusted reference intervals for QTc interval based on quantile smoothing and stepwise quantile approximations. A detailed review of methods for optimizing the quantile estimation procedures is provided. The described methods for computing covariate-adjusted reference intervals are applied to the derivation of reference intervals for absolute values of and changes in QTc interval and other ECG parameters.

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