Rapid implementation of a modular clinical trial informatics solution for COVID-19 research

Veterans Health Administration (VHA) services are most frequently used by patients 65 years and older, an age group that is disproportionally affected by COVID-19. Here we describe a modular Clinical Trial Informatics Solution (CTIS) that was rapidly developed and deployed to support a multi-hospita...

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Autores principales:	Rupali Dhond, Ryan Acher, Sarah Leatherman, Sarah Page, Randolph Sanford, Danne Elbers, Frank Meng, Ryan Ferguson, Mary T. Brophy, Nhan V. Do
Formato:	article
Lenguaje:	EN
Publicado:	Elsevier 2021
Materias:	Electronic health record EHR Veterans Adaptive randomization VHA CDW Computer applications to medicine. Medical informatics R858-859.7
Acceso en línea:	https://doaj.org/article/4281157deaf14681b4f95214271e2b1f
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id	oai:doaj.org-article:4281157deaf14681b4f95214271e2b1f
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spelling	oai:doaj.org-article:4281157deaf14681b4f95214271e2b1f2021-12-02T05:02:11ZRapid implementation of a modular clinical trial informatics solution for COVID-19 research2352-914810.1016/j.imu.2021.100788https://doaj.org/article/4281157deaf14681b4f95214271e2b1f2021-01-01T00:00:00Zhttp://www.sciencedirect.com/science/article/pii/S2352914821002598https://doaj.org/toc/2352-9148Veterans Health Administration (VHA) services are most frequently used by patients 65 years and older, an age group that is disproportionally affected by COVID-19. Here we describe a modular Clinical Trial Informatics Solution (CTIS) that was rapidly developed and deployed to support a multi-hospital embedded pragmatic clinical trial in COVID-19 patients within the VHA. Our CTIS includes tools for patient eligibility screening, informed consent tracking, treatment randomization, EHR data transformation for reporting and interfaces for patient outcome and adverse event tracking. We hope our CTIS component descriptions and practical lessons learned will serve as a useful building block for others creating their own clinical trial tools and have made application and database code publicly available.Rupali DhondRyan AcherSarah LeathermanSarah PageRandolph SanfordDanne ElbersFrank MengRyan FergusonMary T. BrophyNhan V. DoElsevierarticleElectronic health recordEHRVeteransAdaptive randomizationVHACDWComputer applications to medicine. Medical informaticsR858-859.7ENInformatics in Medicine Unlocked, Vol 27, Iss , Pp 100788- (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Electronic health record EHR Veterans Adaptive randomization VHA CDW Computer applications to medicine. Medical informatics R858-859.7
spellingShingle	Electronic health record EHR Veterans Adaptive randomization VHA CDW Computer applications to medicine. Medical informatics R858-859.7 Rupali Dhond Ryan Acher Sarah Leatherman Sarah Page Randolph Sanford Danne Elbers Frank Meng Ryan Ferguson Mary T. Brophy Nhan V. Do Rapid implementation of a modular clinical trial informatics solution for COVID-19 research
description	Veterans Health Administration (VHA) services are most frequently used by patients 65 years and older, an age group that is disproportionally affected by COVID-19. Here we describe a modular Clinical Trial Informatics Solution (CTIS) that was rapidly developed and deployed to support a multi-hospital embedded pragmatic clinical trial in COVID-19 patients within the VHA. Our CTIS includes tools for patient eligibility screening, informed consent tracking, treatment randomization, EHR data transformation for reporting and interfaces for patient outcome and adverse event tracking. We hope our CTIS component descriptions and practical lessons learned will serve as a useful building block for others creating their own clinical trial tools and have made application and database code publicly available.
format	article
author	Rupali Dhond Ryan Acher Sarah Leatherman Sarah Page Randolph Sanford Danne Elbers Frank Meng Ryan Ferguson Mary T. Brophy Nhan V. Do
author_facet	Rupali Dhond Ryan Acher Sarah Leatherman Sarah Page Randolph Sanford Danne Elbers Frank Meng Ryan Ferguson Mary T. Brophy Nhan V. Do
author_sort	Rupali Dhond
title	Rapid implementation of a modular clinical trial informatics solution for COVID-19 research
title_short	Rapid implementation of a modular clinical trial informatics solution for COVID-19 research
title_full	Rapid implementation of a modular clinical trial informatics solution for COVID-19 research
title_fullStr	Rapid implementation of a modular clinical trial informatics solution for COVID-19 research
title_full_unstemmed	Rapid implementation of a modular clinical trial informatics solution for COVID-19 research
title_sort	rapid implementation of a modular clinical trial informatics solution for covid-19 research
publisher	Elsevier
publishDate	2021
url	https://doaj.org/article/4281157deaf14681b4f95214271e2b1f
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Rapid implementation of a modular clinical trial informatics solution for COVID-19 research

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