Kleijnen Systematic Reviews Ltd, Unit 6, Escrick Business Park, Riccall Road, Escrick, York YO19 6FD, United Kingdom.
J Clin Epidemiol. 2013 Oct;66(10):1093-104. doi: 10.1016/j.jclinepi.2013.05.014. Epub 2013 Aug 17.
To classify the sources of bias and variation and to provide an updated summary of the evidence of the effects of each source of bias and variation.
We conducted a systematic review of studies of any design with the main objective of addressing bias or variation in the results of diagnostic accuracy studies. We searched MEDLINE, EMBASE, BIOSIS, the Cochrane Methodology Register, and Database of Abstracts of Reviews of Effects (DARE) from 2001 to October 2011. Citation searches based on three key papers were conducted, and studies from our previous review (search to 2001) were eligible. One reviewer extracted data on the study design, objective, sources of bias and/or variation, and results. A second reviewer checked the extraction.
We summarized the number of studies providing evidence of an effect arising from each source of bias and variation on the estimates of sensitivity, specificity, and overall accuracy.
We found consistent evidence for the effects of case-control design, observer variability, availability of clinical information, reference standard, partial and differential verification bias, demographic features, and disease prevalence and severity. Effects were generally stronger for sensitivity than for specificity. Evidence for other sources of bias and variation was limited.
对偏倚和变异的来源进行分类，并提供关于每种偏倚和变异来源对诊断准确性研究结果影响的最新证据总结。
我们对任何设计的研究进行了系统评价，主要目的是解决诊断准确性研究结果中的偏倚或变异问题。我们检索了 2001 年至 2011 年 10 月期间的 MEDLINE、EMBASE、BIOSIS、Cochrane 方法学登记册和效应摘要数据库 (DARE)。基于三篇关键论文进行了引文搜索，并对我们之前的综述（搜索至 2001 年）中的研究进行了评估。一位评审员提取了关于研究设计、目标、偏倚和/或变异来源以及结果的数据。第二位评审员对提取的数据进行了检查。
我们总结了提供有关每个偏倚和变异来源对敏感性、特异性和总体准确性估计值的影响的研究数量。
我们发现了病例对照设计、观察者变异性、临床信息可用性、参考标准、部分和差异验证偏倚、人口统计学特征以及疾病流行率和严重程度对偏倚和变异的影响具有一致性证据。对于敏感性的影响通常比特异性更强。其他偏倚和变异来源的证据有限。
