Methods for evaluating the performance of diagnostic tests in the absence of a gold standard: a latent class model approach.

In many areas of medical research, 'gold standard' diagnostic tests do not exist and so evaluating the performance of standardized diagnostic criteria or algorithms is problematic. In this paper we propose an approach to evaluating the operating characteristics of diagnoses using a latent class model. By defining 'true disease' as our latent variable, we are able to estimate sensitivity, specificity and negative and positive predictive values of the diagnostic test. These methods are applied to diagnostic criteria for depression using Baltimore's Epidemiologic Catchment Area Study Wave 3 data. Copyright 2002 John Wiley & Sons, Ltd.