Research Methodology for Studies of Diagnostic Tests
Research Methodology for Studies of Diagnostic Tests
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诊断测试研究的研究方法
DOI：
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发表时间：
2014
期刊：
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通讯作者：
S. Glasser
中科院分区：
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作者：
S. Glasser
许多临床研究旨在评估因果关系。然而，临床研究也可以解决新的医学测试的价值，最终将用于筛查风险因素，诊断疾病或评估预后。为了能够构建涉及这些概念的研究问题和设计，必须具备该领域的工作知识。换句话说，虽然传统的临床研究设计可以用来评估其中的一些问题，但大多数评估诊断测试价值的研究更类似于描述性观察设计，但这些设计的目的不是评估因果关系，而是旨在确定诊断测试在临床实践中是否有用。本章将介绍评估诊断试验准确性的各种方法，包括敏感性、特异性、预测值、似然比和受试者操作特征曲线的讨论。
Much of clinical research is aimed at assessing causality. However, clinical research can also address the value of new medical tests, which will ultimately be used for screening for risk factors, to diagnose a disease, or to assess prognosis. In order to be able to construct research questions and designs involving these concepts, one must have a working knowledge of this field. In other words, although traditional clinical research designs can be used to assess some of these questions, most of the studies assessing the value of diagnostic testing are more akin to descriptive observational designs, but with the twist that these designs are not aimed to assess causality, but are rather aimed at determining whether a diagnostic test will be useful in clinical practice. This chapter will introduce the various ways of assessing the accuracy of diagnostic tests, which will include discussions of sensitivity, specificity, predictive value, likelihood ratio, and receiver operator characteristic curves.