What is a simple framework for evaluating a RWE study?

A recent publication by Wang and Schneeweiss provides a streamlined approach for evaluating or conducting RWE studies aimed at evaluating how two treatment options compare with each other. It focuses on the “target trial” concept, on how well various aspects of the study design and analysis align with a hypothetical RCT that could have been done to address the study question.

The authors emphasize three key aspects to consider. First, does the question actually being addressed in the RWE study reflect the question that you are interested in answering? Second, does the study design selected minimize major sources of bias in RWE studies, including selection bias, information/measurement bias and confounding? Finally, are the electronic healthcare data sources both reliable (complete and accurate data capture) and relevant (key study parameters and data are available for enough people in the population of interest over a sufficiently long follow-up period) for the research question being addressed?