2009
DOI: 10.1177/0091270008326717
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Detection of Clinically Significant QTc Prolongation in Phase I Studies in Healthy Participants: Comparison of 2 Semiautomated QT Measurement Methods

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Cited by 7 publications
(6 citation statements)
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“…Evidently, automated measurement techniques, provided these are proven reliable for the detection of small QT changes, would represent an important opportunity to conduct TQT studies more efficiently, as both 'fully manual and manually adjudicated' techniques are laborious and resource intensive. The utility of fully or partially automated measurement techniques has been compared with manual techniques in a number of studies and these techniques have been shown to produce similar results when tested on drugs with a QT prolonging effect (Azie et al, 2004;Sarapa et al, 2004;Darpo et al, 2006a;Fosser et al, 2009;Sarapa et al, 2009a). It has also been shown that different techniques generate different absolute QT intervals (Kligfield et al, 2006;Kligfield et al, 2007), and that some automated techniques consistently demonstrate the same QTc effect measured as change from baseline as manual techniques.…”
Section: Emerging Methods For Qt Interval Measurementsmentioning
confidence: 99%
“…Evidently, automated measurement techniques, provided these are proven reliable for the detection of small QT changes, would represent an important opportunity to conduct TQT studies more efficiently, as both 'fully manual and manually adjudicated' techniques are laborious and resource intensive. The utility of fully or partially automated measurement techniques has been compared with manual techniques in a number of studies and these techniques have been shown to produce similar results when tested on drugs with a QT prolonging effect (Azie et al, 2004;Sarapa et al, 2004;Darpo et al, 2006a;Fosser et al, 2009;Sarapa et al, 2009a). It has also been shown that different techniques generate different absolute QT intervals (Kligfield et al, 2006;Kligfield et al, 2007), and that some automated techniques consistently demonstrate the same QTc effect measured as change from baseline as manual techniques.…”
Section: Emerging Methods For Qt Interval Measurementsmentioning
confidence: 99%
“…Even though there appears to be a limitation to the extent that variability can be reduced with replicates of intervals measured with a semiautomated technique, this does not seem to hold true for other techniques, which do not blend computer-based and manually performed interval measurements. The utility of fully or partially automated measurement techniques has been compared with manual techniques in a number of studies, and these techniques have been shown to produce similar results when tested on drugs with a QT-prolonging effect (Azie et al 2004;Darpo et al 2006;Sarapa et al 2004Sarapa et al , 2009Fosser et al 2009). It has also been shown that different techniques generate different absolute QT intervals (Kligfield et al 2006(Kligfield et al , 2007 and that some automated techniques consistently demonstrate the same QTc effect measured as change from baseline as manual techniques.…”
Section: Ecg Recordings and Qt Interval Measurementsmentioning
confidence: 99%
“…21 The intervals can be measured on multiple leads acquired simultaneously, either by incorporating all representative complexes into a single global complex or by the superimposition of all representative complexes (SIRC). [22][23][24] Use of representative complexes is now more commonly accepted. A recent ICH E14 Q&A document describes the most commonly used methods but does not address their relative performance.…”
Section: P Rolongation Of Cardiac Repolarization Can Causementioning
confidence: 99%
“…Recently, semiautomated methods, in which a trained analyst adjusts fiducial points placed by an automated algorithm, have been advocated. [23][24][25] This approach combines the often accurate approximation of automated interval measurements and the precision of manual adjustments.…”
mentioning
confidence: 99%