• The choice between an observational study and a randomized controlled trial (RCT) is not binary. • No algorithm exists for determining whether an observational study or an RCT is best for answering ...

We identified research questions for each category, broke them down to clinical information elements, and mapped them to the mCODE model. Gaps were further categorized as model deficiencies, ...

• Accounting for bias is a major challenge confronting the use of observational data to gain important insights into real-world treatment effects. • No single study design will satisfy all information ...