JSM 2004 - Toronto

Abstract #300742

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Activity Number: 407
Type: Contributed
Date/Time: Thursday, August 12, 2004 : 8:30 AM to 10:20 AM
Sponsor: General Methodology
Abstract - #300742
Title: Study Design for Evaluation of a Diagnostic Test with Partially Missing Gold Standard
Author(s): Ying Chen*+ and Andrzej Kosinski
Companies: Emory University and Duke University
Address: 1404C Druid Valley Dr., Atlanta, GA, 30329,
Keywords: sensitivity ; specificity ; diagnostic test ; study design ; partially missing gold standard
Abstract:

Sensitivity and specificity are often used to evaluate performance of a diagnostic test. Sufficiently large number of patients is required for the confidence interval for the true sensitivity or specificity to be narrow enough to provide a prespecified precision. In practice, it is common that not all study patients have gold standard ascertained. To achieve the same precision as for the complete gold standard verification situation one requires more patients. The required sample size increases when the proportion of unverified disease status patients increases. We first give the sample size computation approach under the MAR missing data mechanism. Second, the sample size computation with no knowledge of the missing data mechanism is proposed.

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Revised March 2004