Key result
Automated measurement of the QT interval using the tangent or differential threshold methods provided suitable assessment with smaller interreader differences and better reproducibility.
Why the study?
How does automated measurement of the QT interval using new software compare to manual measurement?
Observational
How does automated measurement of the QT interval using new software compare to manual measurement?
Both tangent and differential threshold methods are suitable for automated QT interval assessment, though manual correction by experienced readers remains necessary.
New automated QT software may aid ICH E14 drug-safety assessments; leaves open prospective validation before routine adoption.
BACKGROUND: The International Conference on Harmonization E14 Guideline specifies detailed assessment of QT interval or corrected QT interval prolongation when developing new drugs. We recently devised new software to precisely measure the QT interval. METHODS AND RESULTS: The QT intervals of all leads for a selected single heart beat were compared between automated measurement with the new software from Fukuda Denshi and manual measurement. With both automated and manual measurement, QT intervals obtained by the tangent method were shorter than those obtained by the differential threshold method, but the extent of correction was smaller. QT interval data obtained by the differential threshold method were more similar to values obtained by visual measurement than were data obtained by the tangent method, but the extent of correction was larger. Variability was related to the T-wave amplitude and to setting the baseline and tangent in the tangent method, while skeletal muscle potential noise affected the differential threshold method. Drift, low-amplitude recordings, and T-wave morphology were problems for both methods. Among the 12 leads, corrections were less frequent for leads II and V(3) -V(6) . CONCLUSION: We conclude that, for a thorough assessment of the QT/QTc interval, the tangent method or the differential threshold method appears to be suitable because of smaller interreader differences and better reproducibility. Correction of data should be done by readers who are experienced in measuring the QT interval. It is also important for electrocardiograms to have little noise and for a suitable heart rate and appropriate leads to be selected.
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Kasamaki et al. (2011) conducted an observational in QT interval measurement. Automated measurement with new software vs. Manual measurement was evaluated on QT interval measurement differences. Automated measurement of the QT interval using the tangent or differential threshold methods provided suitable assessment with smaller interreader differences and better reproducibility.
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