title: Efficient Noninferiority Testing Procedures for Simultaneously Assessing Sensitivity and Specificity of Two Diagnostic Tests.
abstract: Sensitivity and specificity are often used to assess the performance of a diagnostic test with binary outcomes. Wald-type test statistics have been proposed for testing sensitivity and specificity individually. In the presence of a gold standard, simultaneous comparison between two diagnostic tests for noninferiority of sensitivity and specificity based on an asymptotic approach has been studied by Chen et al. (2003). However, the asymptotic approach may suffer from unsatisfactory type I error control as observed from many studies, especially in small to medium sample settings. In this paper, we compare three unconditional approaches for simultaneously testing sensitivity and specificity. They are approaches based on estimation, maximization, and a combination of estimation and maximization. Although the estimation approach does not guarantee type I error, it has satisfactory performance with regard to type I error control. The other two unconditional approaches are exact. The approach based on estimation and maximization is generally more powerful than the approach based on maximization.
authors.affiliation: Epidemiology and Biostatistics Program, Department of Environmental and Occupational Health, School of Community Health Sciences, University of Nevada Las Vegas, Las Vegas, NV 89154, USA.
authors.forename: Guogen
authors.initials: G
authors.lastname: Shan
authors.affiliation: Department of Mathematical Sciences, University of Nevada Las Vegas, Las Vegas, NV 89154, USA.
authors.forename: Amei
authors.initials: A
authors.lastname: Amei
authors.affiliation: Division of Health Sciences, University of Nevada Las Vegas, Las Vegas, NV 89154, USA.
authors.forename: Daniel
authors.initials: D
authors.lastname: Young
mesh_terms: D002277:Carcinoma; D003955:Diagnostic Tests, Routine / Q000592:standards / Q000706:statistics & numerical data*; D006801:Humans; D016013:Likelihood Functions; D015233:Models, Statistical; D000077274:Nasopharyngeal Carcinoma; D009303:Nasopharyngeal Neoplasms / Q000175:diagnosis / Q000000981:diagnostic imaging; D009364:Neoplasm Recurrence, Local / Q000175:diagnosis / Q000000981:diagnostic imaging; D011859:Radiography; D011877:Radionuclide Imaging; D018401:Sample Size; D012680:Sensitivity and Specificity