title: A comparison of analysis procedures for correlated binary data in dedicated multi-rater imaging trials.
abstract: In this paper, three analysis procedures for repeated correlated binary data with no a priori ordering of the measurements are described and subsequently investigated. Examples for correlated binary data could be the binary assessments of subjects obtained by several raters in the framework of a clinical trial. This topic is especially of relevance when success criteria have to be defined for dedicated imaging trials involving several raters conducted for regulatory purposes. First, an analytical result on the expectation of the 'Majority rater' is presented when only the marginal distributions of the single raters are given. The paper provides a simulation study where all three analysis procedures are compared for a particular setting. It turns out that in many cases, 'Average rater' is associated with a gain in power. Settings were identified where 'Majority significant' has favorable properties. 'Majority rater' is in many cases difficult to interpret.
authors.affiliation: Global Research and Clinical Development Statistics, Bayer Pharma AG, Berlin, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Kunz
mesh_terms: D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D003952:Diagnostic Imaging / Q000706:statistics & numerical data*; D006801:Humans; D015588:Observer Variation; D013223:Statistics as Topic / Q000379:methods* / Q000592:standards
keywords: clinical trial; correlated binary data; imaging trial; multi-rater trial; multiplicity