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. 2020 Aug 18;18(8):e06221.
doi: 10.2903/j.efsa.2020.6221. eCollection 2020 Aug.

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

EFSA Scientific Committee; Simon More, Vasileos Bambidis, Diane Benford, Claude Bragard, Antonio Hernandez-Jerez, Susanne Hougaard Bennekou, Kostas Koutsoumanis, Kyriaki Machera, Hanspeter Naegeli, Soren Saxmose Nielsen, Josef R Schlatter, Dieter Schrenk, Vittorio Silano, Dominique Turck, Maged Younes, Tony Fletcher, Matthias Greiner, Evangelia Ntzani, Neil Pearce, Marco Vinceti, Laura Ciccolallo, Marios Georgiadis, Andrea Gervelmeyer, Thorhallur I Halldorsson

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

EFSA Scientific Committee et al. EFSA J. .

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 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.

Keywords: Epidemiological studies; evidence appraisal; exposure assessment; hazard characterisation; risk assessment.

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Figures

Figure 1
Figure 1
Risk of bias tools for appraisal of research syntheses or primary research studies (the RoB tools for these are shown in Figures 2–5)
Figure 2
Figure 2
Risk of bias tools for appraisal of primary research studies assessing safety/adequacy or toxicity
Figure 3
Figure 3
Risk of bias tools for appraisal of primary research studies assessing efficacy
Figure 4
Figure 4
Risk of bias tools for appraisal of primary research studies assessing side effects possibly arising in efficacy studies or test accuracy
Figure 5
Figure 5
Risk of bias tools for appraisal of primary research studies assessing descriptive questions, pathogenicity or in silico studies
Figure 6
Figure 6
Scatterplot of the cross‐sectional association between dietary fibre intake and the total‐cholesterol:HDL ratio ((based on the continuous values of the variables) in 178 overweight and obese women aged between 21 and 44 years
Figure 7
Figure 7
Scatterplot of the cross‐sectional association between dietary fibre intake categorized into 4 groups e and the total‐cholesterol:HDL ratio in 178 overweight and obese women aged between 21 and 44 years
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