Precision of QT interval measurement by advanced electrocardiographic equipment
Precision of QT interval measurement by advanced electrocardiographic equipment
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DOI：
10.1111/j.1540-8159.2006.00532.x
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发表时间：
2006-11-01
影响因子：
1.8
通讯作者：
Malik, Marek
中科院分区：
文献类型：
--
作者：
Hnatkova, Katerina;Gang, Yi;Malik, Marek
药物性QT间期延长的临床研究费用主要与人工处理心电图（EGG）记录有关。然而，这些成本可以通过自动EGG测量来降低。为了研究现代EGG设备测量精度的提高，本研究研究了GE Healthcare (Milwaukee， WI， USA) 12SL EGG算法的“旧”和“新”版本的QT间期测量，并将结果与经过仔细验证和协调的手动测量结果进行了比较。调查使用了两组（A和B）起源于大型临床研究的EGG记录。A组和B组分别包含15194条和29866条10秒的EGG记录。所有记录均使用GE医疗记录仪获得，并以数字格式提供，与GE医疗的EGG处理软件兼容。两组录音在EGG质量上存在显著差异，其中B组的噪声污染更严重。与记录集A中仔细的手动QT间期读数相比，“新”和“旧”12SL算法的自动QT间期测量误差分别为（平均值+/- SD） +3.95 +/- 5.50 ms和+0.51 +/- 12.41 ms。在记录集B中，这两个数字分别为+2.41 +/- 9.47 ms和-0.17 +/- 14.89 ms（两者差异具有高度统计学意义，P < 0.000001）。在记录集A中，95.9%和76.6%的心电图是通过12SL算法的“新”和“旧”版本在人工测量后10 ms内自动测量的，在记录集B中，这两个数字分别为83.9%和59.5%。12SL算法“新”版本和“旧”版本的误差模式实际上是相互独立的（记录集A和记录集B的相关系数分别为0.031和0.281）。研究表明(a)与“旧”版本的12SL算法相比，GE医疗最新的EGG设备中实现的“新”版本QT间期测量明显更好，(b) 12SL算法自动测量的精度在很大程度上取决于处理过的EGG记录的质量。“新”12SL算法的改进出现使得在药物开发计划的选定部分使用现代EGG设备而无需任何人工干预成为可能。
The costs of clinical investigations of drug-induced QT interval prolongation are mainly related to manual processing of electrocardiographic (EGG) recordings. Potentially, however, these costs can be decreased by automatic EGG measurement. To investigate the improvements in measurement accuracy of the modern EGG equipment, this study investigated QT interval measurement by the "old" and "new" versions of the 12SL EGG algorithm by GE Healthcare (Milwaukee, WI, USA) and compared the results to carefully validated and reconciled manual measurements. The investigation used two sets (A and B) of EGG recordings that originated from large clinical studies. Sets A and B consisted of 15,194, and 29,866 10-second EGG recordings, respectively. All the recordings were obtained with GE Healthcare recorders and were available in digital format compatible with EGG processing software by GE Healthcare. The two sets of recordings differed significantly in EGG quality with set B being substantially more noise polluted. Compared to careful manual QT interval readings in recording set A, the errors of the automatic QT interval measurement were (mean +/- SD) +3.95 +/- 5.50 ms, and +0.51 +/- 12.41 ms for the "new" and "old" 12SL algorithm, respectively. In recording set B, these numbers were +2.41 +/- 9.47 ms, and -0.17 +/- 14.89 ms, respectively (both differences were highly statistically significant, P < 0.000001). In recording set A, 95.9% and 76.6% of ECGs were measured automatically within 10 ms of the manual measurement by the "new" and "old" versions of the 12SL algorithm, In recording set B, these numbers were 83.9% and 59.5%. The errors mode by the "new" and "old" version of 12SL algorithm were practically independent each of the other (correlation coefficients of 0.031 and 0.281 in recording sets A and B, respectively). The study shows that (a) compared to the "old" version of the 12SL algorithm, the QT interval measurement by the "new" version implemented in the most recent EGG equipment by GE Healthcare is significantly better, and (b) the precision of automatic measurement by the 12SL algorithm is substantially dependent on the quality of processed EGG recordings. The improved occuracy of the "new" 12SL algorithm makes it feasible to use modern EGG equipment without any manual intervention in selected parts of drug-development program.