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科学委员会关于评估和整合流行病学研究证据以供欧洲食品安全局科学评估使用的指南。

Scientific Committee guidance on appraising and integrating evidence from epidemiological studies for use in EFSA's scientific assessments.

作者信息

More Simon, Bampidis Vasileios, Benford Diane, Bragard Claude, Hernandez-Jerez Antonio, Bennekou Susanne Hougaard, Koutsoumanis Konstantinos, Lambré Claude, Machera Kyriaki, Mennes Wim, Mullins Ewen, Nielsen Soren Saxmose, Schlatter Josef, Schrenk Dieter, Turck Dominique, Younes Maged, Fletcher Tony, Greiner Matthias, Ntzani Evangelia, Pearce Neil, Vinceti Marco, Vrijheid Martine, Georgiadis Marios, Gervelmeyer Andrea, Halldorsson Thorhallur I

出版信息

EFSA J. 2024 Jul 5;22(7):e8866. doi: 10.2903/j.efsa.2024.8866. eCollection 2024 Jul.

DOI:10.2903/j.efsa.2024.8866
PMID:38974922
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11224774/
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

欧洲食品安全局要求其科学委员会编写一份关于评估和整合流行病学研究证据以供欧洲食品安全局科学评估使用的指导文件。该指导文件介绍了流行病学研究，并阐述了不同流行病学研究设计中可能存在的典型偏差。接着，它描述了与证据评估相关的关键流行病学概念。这包括对关联度量、暴露评估、统计推断、系统误差和效应修饰的简要解释。该指导文件随后描述了外部有效性的概念以及评估流行病学研究的原则。解释了研究评估过程的定制，包括为评估偏倚风险（RoB）而定制工具。该文件附录了几个使用RoB工具评估实验性和观察性研究的例子，以说明该方法的应用。本指导文件的后半部分重点关注证据整合的不同步骤，首先是在不同证据流内部，然后是跨不同证据流。关于风险特征描述，该指导文件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，该指导文件阐述了在使用人类流行病学研究证据进行风险特征描述时不确定性因素的应用。

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