Reality and Truth
Balancing the Hope and the Hype of Real-World Evidence
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Article, see p 249
The term real-world evidence has very rapidly gained wide acceptance within the parlance of clinical and health services research.1 To many, real-world evidence represents a major opportunity to address a well-acknowledged limitation of randomized clinical trials of drugs and devices relating to generalizability. Such trials are usually highly controlled experiments conducted in selected populations treated in specialized environments, and therefore, the results may not be easily extrapolated to much broader populations managed in diverse usual clinical care situations. Furthermore, the increasing complexity and costs of randomized clinical trials have raised concerns about the sustainability of such approaches in generating evidence to guide health care.
In this issue of Circulation, Kosiborod et al2 report a study described as the provision of real-world evidence. This investigation of the effects of sodium-glucose cotransporter-2 inhibitors (SGLT-2is) on hospitalization for heart failure and death among people with type 2 diabetes mellitus used patient health records from a diverse range of sources across 6 countries in North America and Western Europe. In an observational study design using propensity score matching to account for potential confounding, the authors report that SGLT-2is were associated with significantly improved outcomes. The findings were qualitatively consistent with effects reported in a recent large placebo-controlled trial of empagliflozin in people with type 2 diabetes mellitus and established cardiovascular disease,3 leading the authors to conclude that such effects may be applicable to a broader population of patients managed in real-world clinical practice. The authors further conclude a likely class effect of SGLT-2is and that the effects may be similar among individuals without established cardiovascular disease.
The study by Kosiborod et al2 represents an important addition to the literature and to our understanding of the potential role of SGLT-2is in clinical care. However, it should …