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诊断试验准确性可能随患病率而变化:对循证诊断的启示

Diagnostic test accuracy may vary with prevalence: implications for evidence-based diagnosis.

作者信息

Leeflang Mariska M G, Bossuyt Patrick M M, Irwig Les

机构信息

Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.

出版信息

J Clin Epidemiol. 2009 Jan;62(1):5-12. doi: 10.1016/j.jclinepi.2008.04.007. Epub 2008 Sep 7.

Abstract

BACKGROUND

Several studies and systematic reviews have reported results that indicate that sensitivity and specificity may vary with prevalence.

STUDY DESIGN AND SETTING

We identify and explore mechanisms that may be responsible for sensitivity and specificity varying with prevalence and illustrate them with examples from the literature.

RESULTS

Clinical and artefactual variability may be responsible for changes in prevalence and accompanying changes in sensitivity and specificity. Clinical variability refers to differences in the clinical situation that may cause sensitivity and specificity to vary with prevalence. For example, a patient population with a higher disease prevalence may include more severely diseased patients, therefore, the test performs better in this population. Artefactual variability refers to effects on prevalence and accuracy associated with study design, for example, the verification of index test results by a reference standard. Changes in prevalence influence the extent of overestimation due to imperfect reference standard classification.

CONCLUSIONS

Sensitivity and specificity may vary in different clinical populations, and prevalence is a marker for such differences. Clinicians are advised to base their decisions on studies that most closely match their own clinical situation, using prevalence to guide the detection of differences in study population or study design.

摘要

背景

多项研究和系统评价报告的结果表明,敏感性和特异性可能会随患病率而变化。

研究设计与设置

我们识别并探究了可能导致敏感性和特异性随患病率变化的机制,并用文献中的实例进行说明。

结果

临床变异性和人为变异性可能是患病率变化以及随之而来的敏感性和特异性变化的原因。临床变异性是指临床情况的差异,这可能导致敏感性和特异性随患病率而变化。例如,疾病患病率较高的患者群体可能包括病情更严重的患者,因此,该检测在这一群体中表现更佳。人为变异性是指与研究设计相关的对患病率和准确性的影响,例如,用参考标准对指标检测结果进行验证。患病率的变化会影响由于参考标准分类不完善而导致的高估程度。

结论

敏感性和特异性在不同临床群体中可能会有所不同,患病率是此类差异的一个标志。建议临床医生根据与自身临床情况最匹配的研究来做出决策,利用患病率来指导发现研究人群或研究设计中的差异。

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