Man versus machine: Is there an optimal method for QT measurements in thorough QT studies?
Man versus machine: Is there an optimal method for QT measurements in thorough QT studies?
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DOI：
10.1177/0091270006286900
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发表时间：
2006-06-01
影响因子：
2.9
通讯作者：
Jorkasky, Diane K.
中科院分区：
文献类型：
--
作者：
Darpo, Borje;Agin, Marilyn;Jorkasky, Diane K.
使用3项安慰剂对照全面QT健康志愿者研究的心电图（ECG）记录来比较手动测量获得的QT间期与EGG机器生成的QT间期。对于从两个来源获得的数据，在每个时间点将阳性对照与安慰剂的作用进行比较。手动和自动技术均一致证明阳性对照的QTcF延长具有统计学显著性，两种方法的离群值比例均较小。手动和自动未校正QT间期之间的成对比较显示出明显的差异，其中一台机器得出的间期平均比手动测量的QT间期短16 - 19毫秒，另一台机器得出的间期平均比手动测量的QT间期长7毫秒，但当分析QT相对于基线的变化时，这些差异消失。手动和自动市售QT算法均对阳性对照诱导的QTc间期产生了较小的统计学显著性影响。
Electrocardiographic (ECG) recordings from 3 placebo-controlled thorough QT healthy volunteer studies were used to compare QT intervals obtained by manual measurement with those generated by EGG machines. The effect of the positive control was compared to placebo at each time point for data obtained from both sources. Both manual and automoted techniques consistently demonstrated statistically significant prolongation of QTcF with the positive controls, The proportion of outlier values was small for both methods. The pairwise comparison between manual and automated uncorrected QT intervals demonstrated clear differences, with intervals derived from one machine on average 16 to 19 milliseconds shorter and from the other 7 milliseconds longer than the manually measured QT intervals, but these differences disappeared when analyzing QT change from baseline. Both manual and automated, commercially available QT algorithms demonstrated small statistically significant effects on the QTc interval induced by positive controls.