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Critical appraisal tools (CATs) for evaluation of the evidence from human observational epidemiological studies and further use in weight-of-evidence approaches (EvaRisk)

09/2021-08/2023

Funding programme / funding institution: Europäische Behörde für Lebensmittelsicherheit

Grant number: GP/EFSA/AMU/2020/02

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Project description:

Evidence appraisal is a fundamental step in the use of evidence, as it allows weighing of evidence when it needs to be evaluated/integrated. Systematic evidence appraisal has been performed in several scientific reviews, using Critical Appraisal Tools (CATs) as support. The latter consist of a predefined list of potential sources of bias for the studies selected for risk assessment, guidance for assessing the risk of bias arising from each of these sources, and a narrative or quantified expression of the assessment result. In the "Draft for internal testing Scientific Committee guidance on appraising and integrating evidence from epidemiological studies for use in EFSA's scientific assessments," one of the preliminary recommendations is: Bias risk assessment tools have long been used for randomized controlled trials in humans. There is room for further development of these tools to capture the differences in various observational designs and to use them for other populations (e.g., animals and plants). It is recommended that EFSA collaborate with relevant organizations and initiatives at the European and international levels to harmonize developments in this area. The EvaRisk (Evaluation Methods for Epidemiological Evidence in Risk Assessment) Working Group of the BfR Commission on Evidence-Based Methods in Risk Assessment hasd the development of a Rapid Assessment of Risk of Bias (raRoB) tool for the evaluation of evidence from single observational epidemiological studies in humans in the context of risk assessment. The tool will consist of a list of questions/issues to consider with associated instructions for assessing risk of bias. EvaRisk has developed a draft prototype for a rapid and transparent assessment. Based on this initial draft tool, this project will support the further development, testing, and finalization of a validated tool for assessing evidence from individual observational epidemiologic studies in humans. This tool will be used in BfR and EFSA risk assessments for which such epidemiological results are available, particularly in the areas of pesticides, contaminants, nutrition, food additives, etc. This rapid, standardized and fit-for-purpose tool will allow a more efficient and harmonized assessment of evidence from individual observational epidemiological studies in humans, leading to a more uniform and transparent assessment of epidemiological studies for use in risk assessments.Dissemination of the tool and training of BfR and EFSA staff and experts in its use are very important and will be achieved by organizing two or more workshops and an international scientific conference. In addition, other dissemination activities may also be carried out. It is envisaged that the raRoB tool will enable rapid assessment of primary observational epidemiological studies in humans, which can be used as input for weight of evidence from epidemiological studies.

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