Sample size tables for computer-aided detection studies.

Abstract

Calculating the sample size for a multireader, multicase study of readers' diagnostic accuracy is complicated. Studies in which patients can have multiple findings, as is common in many computer-aided detection (CAD) studies, are particularly challenging to design. We modified existing methods for sample size estimation for multireader, multicase studies to accommodate multiple findings on the same case. We use data from two large multireader, multicase CAD studies as ballpark estimates of parameter values. Sample size tables are presented to provide an estimate of the number of patients and readers required for a multireader, multicase study with multiple findings per case; these estimates may be conservative for many CAD studies. Two figures can be used to adjust the number of readers when there is some data on the between-reader variability. The sample size tables are useful in determining whether a proposed study is feasible with the available resources; however, it is important that investigators compute sample size for their particular study using any available pilot data.