More Simon, Bambidis Vasileos, Benford Diane, Bragard Claude, Hernandez-Jerez Antonio, Bennekou Susanne Hougaard, Koutsoumanis Kostas, Machera Kyriaki, Naegeli Hanspeter, Nielsen Soren Saxmose, Schlatter Josef R, Schrenk Dieter, Silano Vittorio, Turck Dominique, Younes Maged, Fletcher Tony, Greiner Matthias, Ntzani Evangelia, Pearce Neil, Vinceti Marco, Ciccolallo Laura, Georgiadis Marios, Gervelmeyer Andrea, Halldorsson Thorhallur I
EFSA J. 2020 Aug 18;18(8):e06221. doi: 10.2903/j.efsa.2020.6221. eCollection 2020 Aug.
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 of the different epidemiological study designs. It describes key epidemiological concepts relevant for evidence appraisal. Regarding study reliability, measures of association, exposure assessment, statistical inferences, systematic error and effect modification are explained. Regarding study relevance, the guidance describes the concept of external validity. The principles of appraising epidemiological studies are illustrated, and an overview of Risk of Bias (RoB) tools is given. A decision tree is developed to assist in the selection of the appropriate Risk of Bias tool, depending on study question, population and design. The customisation of the study appraisal process is explained, detailing the use of RoB tools and assessing the risk of bias in the body of evidence. Several examples of appraising experimental and observational studies using a Risk of Bias tool are annexed to the document to illustrate the application of the approach. This document constitutes a draft that will be applied in EFSA's assessments during a 1-year pilot phase and be revised and complemented as necessary. Before finalisation of the document, a public consultation will be launched.
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的典型偏差。它描述了与证据评估相关的关键流行病学概念。关于研究可靠性，解释了关联度量、暴露评估、统计推断、系统误差和效应修饰。关于研究相关性，该指导文件描述了外部有效性的概念。阐述了评估流行病学研究的原则，并给出了偏倚风险（RoB）工具的概述。开发了一个决策树，以协助根据研究问题、人群和设计选择合适的偏倚风险工具。解释了研究评估过程的定制，详细说明了RoB工具的使用以及评估证据主体中的偏倚风险。该文件附录了几个使用偏倚风险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。本文件构成一份草案，将在为期1年的试点阶段应用于欧洲食品安全局的评估，并根据需要进行修订和补充。在文件定稿之前，将开展公众咨询。
