Literature DB >> 24521536

Comparison of two methods of estimating reader variability in QT interval measurements in thorough QT/QTc studies.

Vaibhav Salvi1, Dilip R Karnad, Vaibhav Kerkar, Gopi Krishna Panicker, Mili Natekar, Snehal Kothari.   

Abstract

BACKGROUND: Two methods of estimating reader variability (RV) in QT measurements between 12 readers were compared.
METHODS: Using data from 500 electrocardiograms (ECGs) analyzed twice by 12 readers, we bootstrapped 1000 datasets each for both methods. In grouped analysis design (GAD), the same 40 ECGs were read twice by all readers. In pairwise analysis design (PAD), 40 ECGs analyzed by each reader in a clinical trial were reanalyzed by the same reader (intra-RV) and also by another reader (inter-RV); thus, variability between each pair of readers was estimated using different ECGs.
RESULTS: Inter-RV (mean [95% CI]) between pairs of readers by GAD and PAD was 3.9 ms (2.1-5.5 ms) and 4.1 ms (2.6-5.4 ms), respectively, using ANOVA, 0 ms (-0.0 to 0.4 ms), and 0 ms (-0.7 to 0.6 ms), respectively, by actual difference between readers and 7.7 ms (6.2-9.8 ms) and 7.7 ms (6.6-9.1 ms), respectively, by absolute difference between readers. Intra-RV too was comparable.
CONCLUSIONS: RV estimates by the grouped- and pairwise analysis designs are comparable.
© 2014 Wiley Periodicals, Inc.

Keywords:  bootstrapping; data simulation; reader variability; study design; thorough QT study

Mesh:

Year:  2014        PMID: 24521536      PMCID: PMC6932446          DOI: 10.1111/anec.12136

Source DB:  PubMed          Journal:  Ann Noninvasive Electrocardiol        ISSN: 1082-720X            Impact factor:   1.468


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