Session (CTI)

PURPOSE: Recently, there has been increased consideration of real-world data (RWD) and real-world evidence (RWE) in regulatory and health technology assessment (HTA) decision-making. However, information bias (i.e., measurement error, variable and outcome misclassification) can hinder the effective use of RWD. It is thus important for researchers to understand how information bias can impact the validity of RWE and work to mitigate it in their studies. This workshop will provide an overview of information bias in RWD studies, with a focus on electronic health records (EHR) and claims data. Participants will learn about current strategies for information bias mitigation and potential paths forward for best practices. DESCRIPTION: Workshop attendees will obtain a working knowledge of information bias in general and nuances specific to the impact of information bias on studies utilizing EHR/claims data. This workshop will review the recent literature and selected case studies to provide a comprehensive overview. Dr. Arena will chair the session and introduce the topic, highlighting the various ways information bias can impair studies (5 minutes). Mr. Sun will discuss their organization’s strategies for mitigating information bias and present findings from a recent targeted literature review on the topic (15 minutes). Dr. Esposito will then discuss how they address information bias in vaccine studies through both design and quantitative bias analysis (15 minutes). Finally, Dr. Tadros will examine case studies to illustrate practical approaches to addressing information bias in real-world scenarios using Canadian data (15 minutes). Audience participation will include assessment of a proposed tool for information bias mitigation (10 minutes); audience feedback will be used to refine the tool and contribute to proposed best practices. This methods workshop will be of interest to RWE researchers and knowledge users who are concerned about the impact of information bias on their studies.