Clinical validity and clinical utility of genetic tests.
Clinical validity and clinical utility of genetic tests.
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基因检测的临床有效性和临床实用性。
DOI：
10.1002/0471142905.hg0915s60
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发表时间：
2009
影响因子：
--
通讯作者：
Burke,Wylie
中科院分区：
文献类型：
--
作者：
Burke,Wylie
在考虑适当使用新的基因检测时，临床医生和卫生保健政策制定者必须考虑检测识别患者临床状态的准确性（临床有效性）以及使用检测带来的风险和益处（临床实用性）。目前使用的基因测试在准确性和改善健康结果的潜力方面各不相同，这些测试特性可能会受到使用测试的临床环境的影响。此外，临床有效性和实用性的相对重要性根据试验的拟定用途而有所不同。本单元定义了临床有效性和临床实用性，提供了示例，并考虑了这些测试特性对临床实践的影响。
In considering the appropriate use of new genetic tests, clinicians and health care policymakers must consider the accuracy with which a test identifies a patient's clinical status (clinical validity) and the risks and benefits resulting from test use (clinical utility). Genetic tests in current use vary in accuracy and potential to improve health outcomes, and these test properties may be influenced by the clinical setting in which the test is used. In addition, the relative importance of clinical validity and utility varies according to the proposed use of the test. This unit defines clinical validity and clinical utility, provides examples, and considers the implications of these test properties for clinical practice.