Abstract #301813

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JSM 2003 Abstract #301813
Activity Number: 437
Type: Topic Contributed
Date/Time: Thursday, August 7, 2003 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #301813
Title: Verification Bias in the Evaluation of Diagnostic Tests
Author(s): Marina Kondratovich*+
Companies: Food and Drug Administration
Address: CDRH, 1350 Piccard Dr., Division of Biostatistics, Rockville, MD, 20850-4307,
Keywords: diagnostic accuracy ; verification bias ; qualitative tests ; multiple imputation
Abstract:

In prospective studies for comparing the diagnostic accuracy of two qualitative tests or combinations of them, very often the gold standard is not applied to all study subjects. Such selective verification of disease status can cause bias (verification bias) in estimated diagnostic accuracies of the tests. The absence of the disease status for some subjects can be considered a problem of missing data. We discuss different patterns of missing disease status that can occur in the studies of evaluation of qualitative tests (for example, prostate specific antigen test and digital rectal examination for detection of prostate cancer, Papanicolaou test and human papillomavirus test for detection of cervical neoplasia, manual and automated cytology review methods). The multiple imputation technique (Monte Carlo simulation) is discussed.

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