Key result
This introductory guide provides conceptual guidance for reviewing nonrandomized real-world evidence studies that make causal inference.
Why the study?
As real-world evidence studies are increasingly used for clinical and regulatory decision-making, nonspecialists with prior experience primarily in randomized controlled trials need guidance to assess their validity.
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Design
Introductory guide
May aid nonspecialists in appraising causal claims from nonrandomized real-world evidence; leaves open empirical testing of review frameworks.
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.
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Wang et al. (2021) reported a review. This introductory guide provides conceptual guidance for reviewing nonrandomized real-world evidence studies that make causal inference.
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