title: Statistical inference for noninferiority of difference in proportions of clustered matched-pair data from multiple raters.
abstract: In clinical investigations of diagnostic procedures to indicate noninferiority, efficacy is generally evaluated on the basis of results from independent multiple raters. For each subject, if two diagnostic procedures are performed and some units are evaluated, the difference in proportions for matched-pair data is correlated between the two diagnostic procedures and within the subject, i.e. the data are clustered. In this article, we propose a noninferiority test to infer the difference in the correlated proportions of clustered data between the two diagnostic procedures. The proposed noninferiority test was validated in a Monte Carlo simulation study. Empirical sizes of the noninferiority test were close to the nominal level. The proposed test is illustrated on data of aneurysm diagnostic procedures for patients with acute subarachnoid hemorrhage.
authors.affiliation: a Development Department , FUJIFILM RI Pharma Co., Ltd. , Tokyo , Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Saeki
authors.affiliation: b Center for Medical Statistics , Tokyo , Japan.
authors.forename: Toshiro
authors.initials: T
authors.lastname: Tango
authors.affiliation: c Graduate School of Science , Chiba University , Chiba , Japan.
authors.forename: Jinfang
authors.initials: J
authors.lastname: Wang
mesh_terms: D000783:Aneurysm / Q000175:diagnosis; D001699:Biometry; D000074099:Equivalence Trials as Topic; D006801:Humans; D015233:Models, Statistical; D009010:Monte Carlo Method; D013345:Subarachnoid Hemorrhage / Q000150:complications
keywords: Clustered matched-pair data; correlated proportions; multiple raters; noninferiority