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Observed Differences in Diagnostic Test Accuracy between Patient Subgroups: Is It Real or Due to Reference Standard Misclassification?

¹ Screening and Test Evaluation Program, School of Public Health, University of Sydney, Sydney, New South Wales, Australia.
² Department of Clinical Epidemiology and Biostatistics, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.

^aAddress correspondence to this author at: Screening and Test Evaluation Program, School of Public Health, Building A27, University of Sydney, Sydney, New South Wales 2006, Australia. Fax 61-2-93515049; e-mail lesi{at}health.usyd.edu.au.

Abstract

Before a new test is introduced in clinical practice, its accuracy should be assessed. In the past decade, researchers have put an increased emphasis on exploring differences in test sensitivity and specificity between patient subgroups. If the reference standard is imperfect and the prevalence of the target condition differs among subgroups, apparent differences in test sensitivity and specificity between subgroups may be caused by reference standard misclassification. We provide guidance on how to determine whether observed differences may be explained by reference standard misclassification. Such misclassification may be ascertained by examining how the apparent sensitivity and specificity change with the prevalence of the target condition in the subgroups.