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Category: Project

Description: Objective: This protocol outlines the methodology for a comprehensive scoping review aimed at mapping existing tools and frameworks for assessing the risk of bias (RoB) in vaccine effectiveness (VE) research. Methodology: An expert information specialist will craft a comprehensive search strategy. We will explore electronic databases such as MEDLINE, Web of Science, and Embase, covering the period from January 1, 2008, to the present. Additionally, we'll examine grey literature sources from the past five years. Our search will target systematic reviews of VE studies that employ RoB tools/concepts, papers describing the development of such tools/concepts, and articles identifying RoB elements in VE research. We will include any tool or concept designed to evaluate RoB in VE studies, irrespective of the vaccine type or clinical outcomes addressed. Two independent reviewers will screen titles, abstracts, and full texts using a liberal accelerated approach. Data extraction will be performed by one reviewer and verified by another. The findings will be synthesized narratively, focusing on identifying gaps and potential areas for improvement. Implications: The outcomes of this scoping review will provide insights into the current landscape of RoB assessment tools and highlight any gaps or areas for further research. These findings may guide the creation of new tools or the refinement of existing ones to improve RoB assessment in VE studies.