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. 2024 Mar 16;7(1):71.
doi: 10.1038/s41746-024-01068-x.

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

Christine Manta Campbell  1 , Courtney Webster  2   3 , Megan Parisi  4 , Roya Sherafat-Kazemzadeh  5 , Jessica Braid  6 , Thomas Switzer  7 , Marcelo Alves Fávaro  5 , Caprice Sassano  2 , Andrea Coravos  2   8
Affiliations

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

Christine Manta Campbell et al. NPJ Digit Med. .

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.

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Conflict of interest statement

C.M.C., C.S., and A.C. are employees and shareholders of HumanFirst, Inc. C.W. is a compensated consultant for HumanFirst, Inc. M.P. is an employee of Syneos Health Inc. R.S.-K. and M.A.F. are employees of MAPI Research Trust. J.B. is an employee and shareholder of Roche Products Ltd. T.S. is a full-time employee of Genentech Inc. and an owner of shares in Roche.

Figures

Fig. 1
Fig. 1. Patient outcomes are either a biomarker or a clinical outcome assessment (COA), and COAs can be collected passively or actively.
Icons are by flaticon.com.
Fig. 2
Fig. 2. An excerpt of aligned data elements to compare the WI-NRS with actigraphy for the measurement of itch.
1Content available within MAPI Trust’s ePROVIDE™ platform (https://eprovide.mapi-trust.org/). 2Content available within HumanFirst’s Atlas™ platform (https://www.gohumanfirst.com/atlas/platform).
Fig. 3
Fig. 3. Using the aligned framework to identify and compare measurement tools to develop a clinical protocol schedule of assessments.
1Content available within HumanFirst’s Atlas™ platform (https://www.gohumanfirst.com/atlas/platform).
See this image and copyright information in PMC

References

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    1. FDA-NIH Biomarker Working Group. BEST (Biomarkers, EndpointS, and other Tools) Resource (National Institutes of Health, 2016).
    1. Coravos A, et al. Digital medicine: a primer on measurement. Digit. Biomark. 2019;3:31–71. doi: 10.1159/000500413. - DOI - PMC - PubMed
    1. Izmailova, E. S., Guo, C. & Coons, S. J. Conflicting terminology in digital health space: a call for consensus. Appl. Clin. Trials32, 9–10 (2023).
    1. U.S. Food and Drug Administration. Clinical outcome assessments (COA) qualification program submissions. https://www.fda.gov/drugs/clinical-outcome-assessment-coa-qualification-... (2021).