A conceptual framework for external validity.

Abstract

Evidence-Based Medicine (EBM) encourages clinicians to seek the most reputable evidence. The quality of evidence is organized in a hierarchy in which randomized controlled trials (RCTs) are regarded as least biased. However, RCTs are plagued by poor generalizability, impeding the translation of clinical research to practice. Though the presence of poor external validity is known, the factors that contribute to poor generalizability have not been summarized and placed in a framework. We propose a new population-oriented conceptual framework to facilitate consistent and comprehensive evaluation of generalizability, replicability, and assessment of RCT study quality.