RT Journal Article
T1 Draft for internal testing Scientific Committee guidance on appraising and integrating evidence from epidemiological studies for use in EFSA's scientific assessments.
A1 EFSA Scientific Committee, 
A1 More, Simon
A1 Bambidis, Vasileos
A1 Benford, Diane
A1 Bragard, Claude
A1 Hernandez-Jerez, Antonio
A1 Bennekou, Susanne Hougaard
A1 Koutsoumanis, Kostas
A1 Machera, Kyriaki
A1 Naegeli, Hanspeter
A1 Nielsen, Soren Saxmose
A1 Schlatter, Josef R
A1 Schrenk, Dieter
A1 Silano, Vittorio
A1 Turck, Dominique
A1 Younes, Maged
A1 Fletcher, Tony
A1 Greiner, Matthias
A1 Ntzani, Evangelia
A1 Pearce, Neil
A1 Vinceti, Marco
A1 Ciccolallo, Laura
A1 Georgiadis, Marios
A1 Gervelmeyer, Andrea
A1 Halldorsson, Thorhallur I
K1 Epidemiological studies
K1 evidence appraisal
K1 exposure assessment
K1 hazard characterisation
K1 risk assessment
AB 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.
YR 2020
FD 2020-08-18
LK https://hdl.handle.net/10668/26732
UL https://hdl.handle.net/10668/26732
LA en
DS RISalud
RD Apr 17, 2025