The FDA MyStudies app: a reusable platform for distributed clinical trials and real-world evidence studies.

Autor:	Wyner Z; Dana-Farber Cancer Institute, Boston, Massachusetts, USA., Dublin S; Kaiser Permanente Washington Health Research Institute, Kaiser Permanente Washington, Seattle, Washington, USA., Chambers C; Department of Pediatrics, University of California, San Diego, La Jolla, California, USA., Deval S; Boston Technology Corporation, Boston, Massachusetts, USA., Herzig-Marx C; Division of Therapeutics Research and Infectious Disease Epidemiology, Department of Population Medicine, Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA., Rao S; Boston Technology Corporation, Boston, Massachusetts, USA., Rauch A; LabKey, Seattle, Washington, USA., Reynolds J; Division of Therapeutics Research and Infectious Disease Epidemiology, Department of Population Medicine, Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA., Brown JS; Division of Therapeutics Research and Infectious Disease Epidemiology, Department of Population Medicine, Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA., Martin D; Moderna, Inc, Cambridge, Massachusetts, USA.
Jazyk:	angličtina
Zdroj:	JAMIA open [JAMIA Open] 2020 Dec 11; Vol. 3 (4), pp. 500-505. Date of Electronic Publication: 2020 Dec 11 (Print Publication: 2020).
DOI:	10.1093/jamiaopen/ooaa061
Abstrakt:	We developed a mobile application and secure patient data storage platform, FDA MyStudies, to address privacy, engagement, and extensibility challenges in mobile clinical research. The system extends the capabilities of the mobile frameworks Apple ResearchKit and ResearchStack through an intuitive front-end application and secure storage environment that can support health research studies. The platform supports single or multisite studies via role-based access and can be implemented within highly secure data environments. As a proof-of-concept, pregnant women participated in a descriptive study via the app in which data not routinely captured in electronic health records (EHR) were collected and linked with existing patient data to provide a more wholistic view of the patient and illustrate how patient data combined with EHR data could be used to support public health research. (© The Author(s) 2020. Published by Oxford University Press on behalf of the American Medical Informatics Association.)
Databáze:	MEDLINE
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