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Bayesian Sample Size Determination for Prevalence and Diagnostic Test Studies in the Absence of a Gold Standard Test
Author(s) -
Dendukuri Nandini,
Rahme Elham,
Bélisle Patrick,
Joseph Lawrence
Publication year - 2004
Publication title -
biometrics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.298
H-Index - 130
eISSN - 1541-0420
pISSN - 0006-341X
DOI - 10.1111/j.0006-341x.2004.00183.x
Subject(s) - gold standard (test) , statistics , test (biology) , bayesian probability , sample size determination , econometrics , mathematics , biology , paleontology
Summary . Planning studies involving diagnostic tests is complicated by the fact that virtually no test provides perfectly accurate results. The misclassification induced by imperfect sensitivities and specificities of diagnostic tests must be taken into account, whether the primary goal of the study is to estimate the prevalence of a disease in a population or to investigate the properties of a new diagnostic test. Previous work on sample size requirements for estimating the prevalence of disease in the case of a single imperfect test showed very large discrepancies in size when compared to methods that assume a perfect test. In this article we extend these methods to include two conditionally independent imperfect tests, and apply several different criteria for Bayesian sample size determination to the design of such studies. We consider both disease prevalence studies and studies designed to estimate the sensitivity and specificity of diagnostic tests. As the problem is typically nonidentifiable, we investigate the limits on the accuracy of parameter estimation as the sample size approaches infinity. Through two examples from infectious diseases, we illustrate the changes in sample sizes that arise when two tests are applied to individuals in a study rather than a single test. Although smaller sample sizes are often found in the two‐test situation, they can still be prohibitively large unless accurate information is available about the sensitivities and specificities of the tests being used.