Abstract

“X measure is validated.” This sentence commonly appears in methods sections of peer-reviewed manuscripts, research proposals, and in day-to-day conversations in clinical research and clinical care settings. This statement is, at best, noninformative and, at worst, incorrect. As an alternative, we offer a simple framework for how to communicate more nuanced information about the strengths and limitations of a measure by tying it to a specific context of use. The proposed framework aligns with the draft patient-focused drug development guidances that have been recently released by the US Food and Drug Administration (FDA).^1,2