Revisiting the Epistemological Foundations of Evidence‐Based Medicine
Leonardo Y. Kasputis Zanini, Rafael Leite Pacheco, Fábio Bertato, Gabriela C. L. Martins, Rachel Riera, Diego AdãoABSTRACT
Objectives
Evidence‐based medicine (EBM) is frequently characterized as a purely empiricist enterprise. Previous discussions explicitly excluded rationalism from the epistemological analysis of EBM, restricting the discussion to empiricist frameworks. This article argues that such exclusion is untenable and that EBM is better understood as an integrated epistemic system in which empiricist and rationalist dimensions are interdependent and inseparable.
Methods
A commentary with critical epistemological analysis of EBM, drawing on post‐Kantian philosophy of science, to examine the rational structures embedded within EBM's methodology and clinical application.
Results
EBM possesses a clear empiricist dimension in its reliance on systematic observation, controlled experimentation, and measurable outcomes. However, core elements of EBM such as the hierarchy of evidence, risk‐of‐bias assessment criteria, the inferential architecture of meta‐analysis, and the translation of population‐level estimates into individual clinical decisions are rational constructs that precede and organize empirical observation rather than emerging from it. Clinical expertise, integral to Sackett's canonical definition of EBM, operates primarily as a rational faculty. The empiricism–rationalism dichotomy was shown to be fundamentally inadequate, once that all knowledge arises from the interaction between sensory input and conceptual categories.
Conclusion
Characterizing EBM as an exclusive applied empiricism is a philosophical misreading. EBM functions as an integrated epistemic system whose strength lies in the disciplined combination of experience and reason. Recognizing this complex nature provides conceptual tools to better understand both the achievements and the limitations of EBM in clinical practice.