title: Comparative TQT analysis with three fully-automated platforms: comparison to core laboratory semi-automated results.
abstract: OBJECTIVE
  Technological advances in machine-read QT measurement now enable detailed and precise cardiac repolarization assessments. This study assessed the applicability of three state-of-art ECG measurement applications to provide reliable continuous analyses from data obtained in a positive thorough QT study previously characterized with sparse semi-automated measurements performed by an ECG core laboratory.
  
  
  METHODS
  Continuous RR, QT, QTc measurements, and individual QT/RR relationships and their associated intra- and inter-subject variability were derived in parallel with BioQT, Ponemah PRO, and WinAtrec analysis software.
  
  
  RESULTS
  Despite slight vendor-specific differences in measurement variability and QTc, all machine-read methods demonstrated requisite assay sensitivity and yielded similar conclusions in accordance with SA analysis.
  
  
  CONCLUSIONS
  Three commercially available ECG analytical software applications reliably detected the drug-induced QT prolonging effects and replicated the SA core-laboratory conclusions, with greatly improved temporal resolution and reduced analytical costs. With broader experience, these data suggest that current SA methodologies could be effectively replaced by fully automated ECG analysis.
authors.affiliation: Institute of Clinical Pharmacology, F. Hoffmann-La Roche, Strasbourg, France. Electronic address: olivier.meyer.om1@roche.com.
authors.forename: Olivier
authors.initials: O
authors.lastname: Meyer
authors.forename: Gerard
authors.initials: G
authors.lastname: Greig
authors.forename: Henry H
authors.initials: HH
authors.lastname: Holzgrefe
mesh_terms: D000465:Algorithms; D001145:Arrhythmias, Cardiac / Q000175:diagnosis*; D003936:Diagnosis, Computer-Assisted / Q000379:methods*; D004562:Electrocardiography / Q000379:methods*; D006339:Heart Rate / Q000502:physiology*; D006801:Humans; D015588:Observer Variation; D010363:Pattern Recognition, Automated / Q000379:methods*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012984:Software
keywords: ECG core laboratory; Fully-automated QT analysis; QT measurement; Thorough QT study