The Risk of Bias in Vaccine Effectiveness studies (RoB-VE) project, seeks to develop a comprehensive, reliable, and user-friendly risk-of-bias assessment tool and reporting guideline tailored to vaccine effectiveness studies. The project involves 6 steps: focus groups to understand the perspectives of policy-decision makers and the public (Step 1), generation and assessment of signal items identified from our scoping review (Step 2), assessment of the usability, performance, and structure of the draft signal items by applying the items to a random sample of vaccine effectiveness studies (Step 3), creation of the initial rubric, i.e., scoring guide, for risk-of-bias judgements (Step 4), beta-testing of the of the RoB-VE tool and user manual (Step 5), and development of a reporting guideline for vaccine effectiveness studies (Step 6).

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