Assessing and Interpreting Real-World Evidence Studies: Introductory Points for New Reviewers

Nonrandomized real-world evidence (RWE) studies are conducted using healthcare data collected as part of clinical practice. As RWE studies are increasingly considered for regulatory, coverage, and other clinical decision making, nonspecialists will find themselves in the position of assessing the validity of RWE studies, a field that may be less familiar to them. This introductory guide provides conceptual guidance for reviewing RWE studies and is particularly directed at professionals for whom this is new or whose prior experience has primarily been in reviewing randomized controlled trial evidence. We focus on RWE studies that make causal inference, evaluating whether one treatment option is better, worse, or neutral compared to another. Although we provide citations to direct the reader to resources with more details on complex issues, this guide cannot substitute for years of training and expertise in the field.