PDF(Pubmed)
Abstract：
EFSA requested its Scientific Committee to prepare a guidance document on appraising and integrating evidence from epidemiological studies for use in EFSA\'s scientific assessments. The guidance document provides an introduction to epidemiological studies and illustrates the typical biases, which may be present in different epidemiological study designs. It then describes key epidemiological concepts relevant for evidence appraisal. This includes brief explanations for measures of association, exposure assessment, statistical inference, systematic error and effect modification. The guidance then describes the concept of external validity and the principles of appraising epidemiological studies. The customisation of the study appraisal process is explained including tailoring of tools for assessing the risk of bias (RoB). Several examples of appraising experimental and observational studies using a RoB tool are annexed to the document to illustrate the application of the approach. The latter part of this guidance focuses on different steps of evidence integration, first within and then across different streams of evidence. With respect to risk characterisation, the guidance considers how evidence from human epidemiological studies can be used in dose-response modelling with several different options being presented. Finally, the guidance addresses the application of uncertainty factors in risk characterisation when using evidence from human epidemiological studies.
摘要：
EFSA要求其科学委员会准备一份关于评估和整合流行病学研究证据的指导文件，用于EFSA的科学评估。指导文件介绍了流行病学研究，并说明了典型的偏见，可能存在于不同的流行病学研究设计中。然后描述了与证据评估相关的关键流行病学概念。这包括对关联措施的简要解释，暴露评估，统计推断，系统误差和效应修正。然后，指南描述了外部有效性的概念和评估流行病学研究的原则。解释了研究评估过程的定制，包括定制用于评估偏倚风险（RoB）的工具。该文件附有使用RoB工具评估实验和观察研究的几个例子，以说明该方法的应用。本指南的后半部分侧重于证据整合的不同步骤，首先是在不同的证据流中，然后是在不同的证据流中。关于风险表征，该指南考虑了如何将人类流行病学研究的证据用于剂量反应建模，并提出了几种不同的选择。最后,该指南讨论了使用人类流行病学研究证据时，不确定性因素在风险表征中的应用。
