An Ontology for Digital Medicine Outcomes: Development of the Digital Medicine Outcomes Value Set (DOVeS)

Preprint Value (mathematics) Digital Health
DOI: 10.2196/67589 Publication Date: 2025-01-12T09:03:47Z
ABSTRACT
Background Over the last 10-15 years, US health care and practice of medicine itself have been transformed by a proliferation digital therapeutic products (collectively, tools [DHTs]). While number DHT classifications proposed to help organize these for discovery, retrieval, comparison organizations seeking potentially implement them, none specifically addressed that considering their implementation approach discovery process with one or more specific outcomes in mind. An outcomes-based ontology could therefore be valuable not only systems evaluate influence certain outcomes, but also regulators vendors ascertain potential substantial equivalence predicate devices. Objective This study aimed develop, inputs from industry, providers, payers, regulatory bodies, patients through Accelerated Digital Clinical Ecosystem (ADviCE) consortium, an Outcomes Value Set (DOVeS), make this publicly available free use. Methods From starting point 4-generation–deep hierarchical taxonomy developed ADviCE, we DOVeS using Web Ontology Language open-source editor Protégé, data 185 who had submitted structured product information ADviCE. We used custom, decentralized, collaborative engineering methodology, were guided Open Biological Biomedical Ontologies (OBO) Foundry principles. incorporated Mondo Disease (MONDO) Adverse Events. After development, was field-tested between December 2022 May 2023 40 additional independent previously unfamiliar ADviCE DOVeS. As proof concept, subsequently prototype Application Finder leveraging enable user query based on interest. Results In its current state, contains 42,320 9481 native axioms distinct classes, respectively. These numbers are enhanced when taking into account classes contributed MONDO Conclusions is BioPortal GitHub, has Creative Commons license CC-BY-SA intended encourage stakeholders modify, adapt, build upon, distribute it. no complete, will benefit strong engaged base it grow evolve way best serves they serve.
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