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


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.

SUBMITTER: Campbell CM 

PROVIDER: S-EPMC10944461 | biostudies-literature | 2024 Mar

REPOSITORIES: biostudies-literature

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

Campbell Christine Manta CM   Webster Courtney C   Parisi Megan M   Sherafat-Kazemzadeh Roya R   Braid Jessica J   Switzer Thomas T   Alves Fávaro Marcelo M   Sassano Caprice C   Coravos Andrea A  

NPJ digital medicine 20240316 1


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. ...[more]

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