Do automated measurement methods of the QT interval perform comparably to manual and computer-assisted methods in healthy volunteers?
Automated, manual, and computer-assisted QT measurement methods perform comparably for demonstrating assay sensitivity in thorough QT studies, though automated methods demonstrate slightly less variability.
We analyzed five crossover, thorough QT (TQT) studies to compare automated, manual, and computer-assisted (CA) measurement methods. All the methods detected moxifloxacin-induced, baseline-adjusted, placebo-subtracted mean changes in Fridericia-corrected QT interval (QTcF), with peak effect ranging from 10 to 21 ms. The variability associated with manual and CA measurements was generally 5-28% greater than that associated with automated methods. The performances of automated, manual, and CA measurements were comparable for the purpose of demonstrating assay sensitivity in TQT studies with healthy volunteers.
Fosser et al. (2009) studied this question.