Table 3.

Summary of introductory points on assessing and interpreting RWE studies

Question	Compare the components of the PICOT question that you want to address to the research question that is actually addressed by the study. Re-engineering the hypothetical trial that was emulated by the RWE study is a helpful thought experiment to identify the precise study question.
Design	Map out a hypothetical target trial that would address your PICOT question of interest and compare to the RWE study parameters implemented to help think about potential sources of design-related biases. Consider creating a design diagram to be clearly summarize time 0 in the RWE study (parallel to randomization date for a trial) and other temporal anchors.
Data
Reliability	Consider how closely the elements of the database reflect the clinical constructs they are supposed to.
Relevance	Consider whether and how well key study parameters are measurable in the data.

PICOT, Population, Intervention, Comparator, Outcome, and Timing; RWE, real-world evidence.