title: Multireader multicase reader studies with binary agreement data: simulation, analysis, validation, and sizing.
abstract: We treat multireader multicase (MRMC) reader studies for which a reader's diagnostic assessment is converted to binary agreement (1: agree with the truth state, 0: disagree with the truth state). We present a mathematical model for simulating binary MRMC data with a desired correlation structure across readers, cases, and two modalities, assuming the expected probability of agreement is equal for the two modalities ([Formula: see text]). This model can be used to validate the coverage probabilities of 95% confidence intervals (of [Formula: see text], [Formula: see text], or [Formula: see text] when [Formula: see text]), validate the type I error of a superiority hypothesis test, and size a noninferiority hypothesis test (which assumes [Formula: see text]). To illustrate the utility of our simulation model, we adapt the Obuchowski-Rockette-Hillis (ORH) method for the analysis of MRMC binary agreement data. Moreover, we use our simulation model to validate the ORH method for binary data and to illustrate sizing in a noninferiority setting. Our software package is publicly available on the Google code project hosting site for use in simulation, analysis, validation, and sizing of MRMC reader studies with binary agreement data.
authors.affiliation: Food and Drug Administration, Center for Devices and Radiological Health , Office of Science and Engineering Laboratories, Division of Imaging, Diagnostics, and Software Reliability, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993, United States.
authors.forename: Weijie
authors.initials: W
authors.lastname: Chen
authors.affiliation: Food and Drug Administration, Center for Devices and Radiological Health , Office of Science and Engineering Laboratories, Division of Imaging, Diagnostics, and Software Reliability, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993, United States.
authors.forename: Adam
authors.initials: A
authors.lastname: Wunderlich
authors.affiliation: Food and Drug Administration, Center for Devices and Radiological Health , Office of Science and Engineering Laboratories, Division of Imaging, Diagnostics, and Software Reliability, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993, United States.
authors.forename: Nicholas
authors.initials: N
authors.lastname: Petrick
authors.affiliation: Food and Drug Administration, Center for Devices and Radiological Health , Office of Science and Engineering Laboratories, Division of Imaging, Diagnostics, and Software Reliability, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993, United States.
authors.forename: Brandon D
authors.initials: BD
authors.lastname: Gallas
keywords: Monte Carlo simulation; binary data; multireader multicase; reader study; sizing