Negative controls: a tool for detecting confounding and bias in observational studies.
Negative controls: a tool for detecting confounding and bias in observational studies.
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DOI：
10.1097/ede.0b013e3181d61eeb
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发表时间：
2010-05
期刊：
影响因子：
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通讯作者：
Cohen T
中科院分区：
文献类型：
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作者：
Lipsitch M;Tchetgen Tchetgen E;Cohen T
暴露与结果之间的非因果关联对观察性研究中因果推断的有效性构成威胁。已经开发了许多研究设计和分析技术来识别和消除这些错误。这些问题并不会影响实验研究，在实验研究中，仔细的标准化条件（用于实验室工作）和随机化（用于人群研究）如果应用得当，应该可以消除大多数此类非因果关联。然而，我们认为，在生物实验室实验设计中采取的常规预防措施——使用“阴性对照”——旨在检测可疑和未怀疑的虚假因果推理来源。在流行病学中，类似的阴性对照有助于识别和解决混淆以及其他错误来源，包括回忆偏差或分析缺陷。我们区分了两种类型的阴性对照（暴露对照和结果对照），描述了流行病学文献中每种类型的例子，并确定了使用这种阴性对照来检测混杂的条件。我们的结论是，阴性对照应该更普遍地应用于观察性研究中，并且需要额外的工作来明确在何种条件下阴性对照将成为观察性研究中其他误差来源的敏感检测器。
Non-causal associations between exposures and outcomes are a threat to validity of causal inference in observational studies. Many techniques have been developed for study design and analysis to identify and eliminate such errors. Such problems are not expected to compromise experimental studies, where careful standardization of conditions (for laboratory work) and randomization (for population studies) should, if applied properly, eliminate most such non-causal associations. We argue, however, that a routine precaution taken in the design of biological laboratory experiments—the use of “negative controls”—is designed to detect both suspected and unsuspected sources of spurious causal inference. In epidemiology, analogous negative controls help to identify and resolve confounding as well as other sources of error, including recall bias or analytic flaws. We distinguish two types of negative controls (exposure controls and outcome controls), describe examples of each type from the epidemiologic literature, and identify the conditions for the use of such negative controls to detect confounding. We conclude that negative controls should be more commonly employed in observational studies, and that additional work is needed to specify the conditions under which negative controls will be sensitive detectors of other sources of error in observational studies.