Suchergebnisse

Abstract
This report outlines the methodologies and outcome of the project developed under Framework Partnership Agreement (FPA) No GP/EFSA/AMU/2020/02 – Specific Agreement No. 05 entitled "Critical appraisal tools (CATs) for evaluation of the evidence from human observational epidemiological studies and further use in weight‐of‐evidence approaches" by Federal Institute for Risk Assessment (BfR) and EFSA. A tool for the rapid assessment of risk of bias (raRoB) in observational epidemiological human studies was developed. Even though, numerous tools for assessing methodological quality have been published, only few are applicable to observational studies. In the context of risk assessment, a tool was created to assess the risk of bias that is easy to use, even for those with only basic epidemiological knowledge. This tool is transparent, relatively quick to use and consists of five domains (Selection, Exposure, Outcome, Confounding, Follow‐up, Analysis, Selective reporting). The tool itself was tested in three rounds with experts and step by step improved. The accompanying documentation was also revised due to expert's comments. The raRoB tool allows a transparent documentation of the assessment of human observational epidemiological human studies with items in each domain and a summary of the scores and an indication for the worst ratio. Expert can additionally write their appraisal for their scores in their own words. This allows transparency and comparability.

ZusammenfassungZiel dieser Arbeit ist die Beschreibung der Entwicklung einer webbasierten, interaktiven Darstellung von maximalen tolerierbaren Verzehrmengen für ausgewählte Lebensmittel, die beispielsweise in einer Ereignissituation als potenziell kontaminiert angenommen werden ("Kontaminantenrechner"). Die vorliegende Arbeit beschreibt einen Katalog wissenschaftlicher Anwendungskriterien für einen solchen Kontaminantenrechner. Als Anwendungsbeispiel wird der Fipronil-Ereignisfall im Sommer 2017 verwendet.

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.