Grant: Project Grant

Making sure vaccine effectiveness (VE) studies are reliable is very important for shaping vaccination policies and recommendations. These studies measure how well vaccines work across diverse populations in real-world scenarios, from routine to emergency situations. They provide information that cannot be obtained through clinical trials, where vaccines are evaluated under strictly controlled conditions. However, the diversity in study designs, coupled with potential biases, poses a significant challenge in bringing evidence together effectively. One big challenge is the assessment of risk of bias, which is the likelihood that specific aspects of the study (e.g. data collection methods, ways in which participants are recruited, etc.) may yield misleading results. Risk of bias assessment is a key element of the process guiding guideline development. While existing tools aim to standardize this process, they fall short in addressing the unique characteristics of VE studies. Our project bridges this gap through the development, validation, and dissemination of a robust and user-friendly risk-of-bias assessment tool, specifically tailored for assessing VE studies. Our methodology involves a comprehensive multi-step process based on established approaches. A broad range of international participants with diverse expertise and profiles will be engaged along the way to refine and finalize the tool. After pilot testing the Beta version of the tool and making further refinements, we aim to deliver Version 1 of the tool, which will undergo a large-scale application phase to assess its reliability and usefulness. Additionally, we will develop a reporting guideline to enhance the completeness of reporting VE studies. This project will elevate the standards of evidence synthesis, ultimately contributing to more reliable, transparent, and impactful research in the critical field of VE evaluation.