The novacode criteria for classification of ECG abnormalities and their clinically significant progression and regression
The novacode criteria for classification of ECG abnormalities and their clinically significant progression and regression
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DOI：
10.1016/s1053-0770(98)90132-x
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发表时间：
1998-07-01
影响因子：
1.3
通讯作者：
Zhang, ZM
中科院分区：
文献类型：
--
作者：
Rautaharju, PM;Park, LP;Zhang, ZM
临床和亚临床心血管疾病的心电图（ECG）表现被用作临床试验评价的重要组成部分，并且对ECG异常临床显著进展的明确定义标准的需求日益增加。Novacode ECG分类系统提供了一套全面的分层标准，用于普遍的ECG异常和具有临床意义的连续ECG变化（不良和有利），作为对药物、手术和其他干预的反应。这些标准用于对Q波和缺血性异常进行分级，以实现对流行性和偶发性心肌梗死的稳定分类，从而最大限度地减少由于临床上不显著的ECG变化而导致的错误分类。这种方法不同于传统的明尼苏达州代码分类系统，在该系统中，事故事件是由分类类别的变化确定的，并应用额外的详细验证规则来排除频繁的错误分类。Novacode分级结构是这样构建的，对于每种异常：首先用最简单的可能分类标准确定一般类别，然后用更详细的标准对更具体的异常子组进行分类。这种方法将满足临床试验对分类细节的不同需求。ECG变量的明确定义和分类标准的条件语句便于Novacode与计算机ECG程序的实施。
Electrocardiographic (ECG) manifestations of clinical and subclinical cardiovascular disease are used as an important component in the evaluation of clinical trials, and there is an increasing demand for well-defined criteria for clinically significant evolution of ECG abnormalities. The Novacode ECG classification system provides a comprehensive hierarchical set of criteria for prevalent ECG abnormalities and for clinically significant serial ECG changes, both adverse and favorable, as a response to pharmacologic, surgical, and other interventions. These criteria are used to grade Q wave and ischemic abnormalities in order to achieve stable classification of both prevalent and incident myocardial infarctions jy minimizing false classifications due to clinically insignificant ECG variations. This approach differs from the traditional Minnesota Code classification system, in which incident events are determined by changes in classification categories, with the application of additional elaborate validation rules to exclude frequent false classifications. Novacode hierarchy is so structured that for each abnormality: a general class is first determined with the simplest possible classification criteria and more specific abnormality sub-groups are then classified with more elaborate criteria. This approach will satisfy differing needs of clinical trials for detail in classification. Explicit definition of ECG variables and condition statements for the classification criteria facilitate implementation of the Novacode with computer ECG programs.