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

The aim of this project is to develop at BfRshort forGerman Federal Institute for Risk Assessment, together with EFSAshort forEuropean Food Safety Authority, a Rapid Assessment of Risk of BiasClose dialogBiasBiasTo glossary (raRoB) tool for the assessment of evidence from individual observational epidemiological studies in the context of risk assessment. The rapid, standardized, and fit-for-purpose tool will consist of a list of questions/issues to be considered with the appropriate instructions for assessing the risk of bias from individual observational epidemiologic studies in humans. The use of the tool may lead to a more harmonized, consistent and transparent assessment of epidemiological studies for EFSAshort forEuropean Food Safety Authority and BfRshort forGerman Federal Institute for Risk Assessment risk assessments. Dissemination of the tool and training of EFSAshort forEuropean Food Safety Authority and BfRshort forGerman Federal Institute for Risk Assessment staff and experts in its use are very important and will be achieved by organizing two or more workshops and an international scientific conference.

The project aimed at the further development of a tool for rapid assessment of the evidence with focus on risk of bias of human observational epidemiological studies in the context of public health and risk assessment as well as the organization of four related workshops and an international conference. All these objectives have been completed. A final (at this point of the development) version of a tool for rapid assessment of risk of bias (raRoB tool) along with a manual has been developed in scientific cooperation within the BfRshort forGerman Federal Institute for Risk Assessment-EFSAshort forEuropean Food Safety Authority project team by means of a pilot phase and two test cycles. Four half-day online workshops as well as one workshop in presence with more than 60 international participants have been successfully conducted and provided constructive input and positive feedback on the applicability of the tool. The outlook for the further development of the raRoB tool includes the consideration of further changes to the item structure and other study types (e.g., prevalence studies). A synergy effect is created by adapting the instrument for use in animal populations ("raRoB-vet", see SA13 of this FPA). While the "animal" instrument benefits from all the experience gained with raRoB, the adaptation process may generate additional useful hints on the "human" instrument, in particular since the adaptation process is supported by a Delphi process involving a larger international group of experts. Another synergy effect of the joint development of both instruments is the development of an alternative web-based technical solution for the instruments. An international conference on "Using Epidemiological Studies in Health Risk Assessment" was held at the BfRshort forGerman Federal Institute for Risk Assessment in Berlin (9-11 November 2023) with a total of up to 764 participants (online and on site). The conference comprised nineteen scientific lectures as well as short statements, poster presentations and a panel discussion. The feedback evaluation of the conference showed that the conference was very well received. A follow-up event and a scientific publication is considered depending on upcoming priorities.