The architecture of diagnostic research
The architecture of diagnostic research
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诊断研究的架构
作者：
D. Sackett;R. Haynes
这是五篇文章系列中的第二篇
为了实现诊断测试的最大有效性和实用性，在临床医学和科学方法之间的接口上付出了相当大的努力。本文重点讨论诊断研究中出现的特定类型问题以及用于回答这些问题的研究架构（将这些临床问题转换为适当的研究设计）。作为一个例子，我们将评估 B 型钠尿肽 (BNP) 的血浆浓度在诊断左心室功能障碍中的价值。1 随机对照试验在别处讨论。
与其他形式的临床研究一样，有几种不同的方法来研究体征或实验室测试的潜在或真实诊断价值，每种方法都适合一种问题，而不适合其他问题。在关于假定的诊断测试与目标疾病（例如，BNP 浓度和左心室功能障碍）之间关系的可能问题中，有四个是最相关的。
#### 总结要点
诊断研究应将方法与诊断问题相匹配
诊断测试研究有效性的关键是
当相同的诊断测试应用于初级、……时，特异性和敏感性都可能发生变化。
This is the second in a series of five articles
Considerable effort has been expended at the interface between clinical medicine and scientific methods to achieve the maximum validity and usefulness of diagnostic tests. This article focuses on the specific kinds of questions that arise in diagnostic research and the study architectures (the conversions of these clinical questions into appropriate research designs) used to answer them. As an example we shall take shall take assessment of the value of the plasma concentration of B-type natriuretic peptide (BNP) in the diagnosis of left ventricular dysfunction.1 Randomised controlled trials are dealt with elsewhere.
As in other forms of clinical research, there are several different ways studying the potential or real diagnostic value of a physical sign or laboratory test, and each is appropriate to one kind of question and inappropriate for others. Among the possible questions about the relation between a putative diagnostic test and a target disorder (for example, the concentration of BNP and left ventricular dysfunction), four are most relevant.
#### Summary points
Diagnostic studies should match methods to diagnostic questions
The keys to validity in diagnostic test studies are
Both specificity and sensitivity may change as the same diagnostic test is applied in primary, …