title: Analysis of clustered matched-pair data for a non-inferiority study design.
abstract: Hypothesis testing of matched-pair data has been adapted for equivalence (one- and two-sided) study designs; however, a statistical problem arises when more than one measurement is recorded for each study subject. Ignoring the correlation between the repeated measurements per subject may underestimate the standard error of the parameter estimate. A method of testing for non-inferiority or equivalence of clustered matched-pair data is not yet available. This paper proposes a Wald-type test statistic for a non-inferiority hypothesis and applies it to the comparison of two diagnostic procedures.
authors.affiliation: TCIG*STATS, The Clinical Innovation Group, MUSC Foundation for Research Development, Charleston, SC, USA. durkalsv@musc.edu
authors.forename: Valerie L
authors.initials: VL
authors.lastname: Durkalski
authors.forename: Yuko Y
authors.initials: YY
authors.lastname: Palesch
authors.forename: Stuart R
authors.initials: SR
authors.lastname: Lipsitz
authors.forename: Philip F
authors.initials: PF
authors.lastname: Rust
mesh_terms: D003198:Computer Simulation; D006801:Humans; D006961:Hyperparathyroidism / Q000000981:diagnostic imaging; D016555:Matched-Pair Analysis; D012107:Research Design; D012680:Sensitivity and Specificity; D013223:Statistics as Topic; D014055:Tomography, Emission-Computed; D015899:Tomography, Emission-Computed, Single-Photon