SciRAPepi Tool: Optimization of the SciRAP Tool for Evaluating the Reliability and Relevance of Observational Epidemiological Studies for Hazard and Risk Assessment of Chemicals

The Science in Risk Assessment and Policy (SciRAP) platform has been developed to support the structured and transparent evaluation of data in hazard and risk assessment of chemicals. This work aimed to develop a SciRAP tool for the evaluation of the reliability and relevance of observational epidemiological studies (SciRAPepi tool), including cross-sectional, classical case-control, nested case-control, and cohort studies. A first version of the SciRAPepi tool was created, and an expert testing round was conducted to assess its scientific soundness and user-friendliness. Thirty-seven epidemiologists and risk assessors took part in the testing using the tool to evaluate four epidemiological studies representing the main epidemiological study designs. The majority of experts considered the criteria appropriate, and overall evaluations indicated good consistency across most criteria. Based on the testing results, the tool was further developed and refined. Together with the SciRAPepi tool, guidance and instructions on its use were developed, along with a reporting checklist to support researchers in reporting their studies. The SciRAPepi tool intends to enhance the use of reliable epidemiological data in the hazard and risk assessment of chemicals and other scientific assessments, offering a broader range of options for evaluating these data for epidemiologists and risk assessors.