An aligned framework of actively collected and passively monitored clinical outcome assessments (COAs) for measure selection.

Campbell, Christine Manta; Webster, Courtney; Parisi, Megan; Sherafat-Kazemzadeh, Roya; Braid, Jessica; Switzer, Thomas; Alves Fávaro, Marcelo; Sassano, Caprice et al. · NPJ Digit Med · 2024

review · Level V

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Abstract

Regulators increasingly require clinical outcome assessment (COA) data for approval. COAs can be collected via questionnaires or digital health technologies (DHTs), yet no single resource provides a side-by-side comparison of tools that collect complementary or related COA measures. We propose how to align ontologies for actively collected and passively monitored COAs into a single framework to allow for rapid, evidence-based, and fit-for-purpose measure selection.