ISPE-Endorsed Guidance in Using Electronic Health Records for Comparative Effectiveness Research in COVID-19: Opportunities and Trade-Offs

Grammati Sarri; Dimitri Bennett; Thomas Debray; Anouk Deruaz-Luyet; Montse Soriano Gabarró; Joan A. Largent; Xiaojuan Li; Wei Liu; Jennifer L. Lund; Daniela C. Moga; Mugdha Gokhale; Christopher T. Rentsch; Xuerong Wen; Chen Yanover; Yizhou Ye; Huifeng Yun; Andrew R. Zullo; Kueiyu Joshua Lin

doi:10.1002/cpt.2560

ISPE-Endorsed Guidance in Using Electronic Health Records for Comparative Effectiveness Research in COVID-19: Opportunities and Trade-Offs

Grammati Sarri, Dimitri Bennett, Thomas Debray, Anouk Deruaz-Luyet, Montse Soriano Gabarró, Joan A. Largent, Xiaojuan Li, Wei Liu, Jennifer L. Lund, Daniela C. Moga, Mugdha Gokhale, Christopher T. Rentsch, Xuerong Wen, Chen Yanover, Yizhou Ye, Huifeng Yun, Andrew R. Zullo, Kueiyu Joshua Lin

Research output: Contribution to journal › Article › peer-review

8 Scopus citations

Abstract

As the scientific research community along with healthcare professionals and decision makers around the world fight tirelessly against the coronavirus disease 2019 (COVID-19) pandemic, the need for comparative effectiveness research (CER) on preventive and therapeutic interventions for COVID-19 is immense. Randomized controlled trials markedly under-represent the frail and complex patients seen in routine care, and they do not typically have data on long-term treatment effects. The increasing availability of electronic health records (EHRs) for clinical research offers the opportunity to generate timely real-world evidence reflective of routine care for optimal management of COVID-19. However, there are many potential threats to the validity of CER based on EHR data that are not originally generated for research purposes. To ensure unbiased and robust results, we need high-quality healthcare databases, rigorous study designs, and proper implementation of appropriate statistical methods. We aimed to describe opportunities and challenges in EHR-based CER for COVID-19-related questions and to introduce best practices in pharmacoepidemiology to minimize potential biases. We structured our discussion into the following topics: (1) study population identification based on exposure status; (2) ascertainment of outcomes; (3) common biases and potential solutions; and (iv) data operational challenges specific to COVID-19 CER using EHRs. We provide structured guidance for the proper conduct and appraisal of drug and vaccine effectiveness and safety research using EHR data for the pandemic. This paper is endorsed by the International Society for Pharmacoepidemiology (ISPE).

Original language	English
Pages (from-to)	990-999
Number of pages	10
Journal	Clinical Pharmacology and Therapeutics
Volume	112
Issue number	5
DOIs	https://doi.org/10.1002/cpt.2560
State	Published - Nov 2022

Bibliographical note

Publisher Copyright:
© 2022 The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.

Funding

G.S. is employed by Cytel Inc. DB is an employee of Takeda. A.R.Z. has received grant funding from Sanofi Pasteur direct to Brown University for research on the epidemiology of infections and vaccinations among nursing home residents and infants. A.D.L is an employee of Boehringer Ingelheim International. M.S.G. is an employee of Bayer AG and owns stock in the company. Y.Y. is an employee of AbbVie and may own AbbVie stock or options. J.L.’s spouse is an employee of GlaxoSmithKline and owns stock in the company. J.A.L. is an employee of IQVIA and owns stock in the company. M.G. is an employee of Merck and owns stock in the company. H.Y. has research grant from Pfizer for unrelated work. T.D. provides consulting services to pharma industry. C.T.R., X.L., W.L., X.W., C.Y., J.K.L., and D.C.M. declared no competing interests for this work. Funding for the development of this paper was provided by ISPE ( https://www.pharmacoepi.org/ISPE/assets/File/General/Manuscript%20Proposals%20Previously%20Accepted.pdf ). Funding for the development of this paper was provided by ISPE (https://www.pharmacoepi.org/ISPE/assets/File/General/Manuscript%20Proposals%20Previously%20Accepted.pdf). This paper is endorsed by the International Society for Pharmacoepidemiology (ISPE). We acknowledge the support of research assistants (Winnie Ho and Luke Edward Zabotka) in searching and reviewing some of the supporting materials for the development of this manuscript. We also thank Dr. Gianluca Trifiro, a member of the International Society for Pharmacoepidemiology, for his participation.

Funders	Funder number
ISPE
National Institute on Aging	R01AG065722
Pfizer
Sanofi Pasteur
International Society for Pharmacoepidemiology

ASJC Scopus subject areas

Pharmacology
Pharmacology (medical)

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1002/cpt.2560

Cite this

Sarri, G., Bennett, D., Debray, T., Deruaz-Luyet, A., Soriano Gabarró, M., Largent, J. A., Li, X., Liu, W., Lund, J. L., Moga, D. C., Gokhale, M., Rentsch, C. T., Wen, X., Yanover, C., Ye, Y., Yun, H., Zullo, A. R., & Lin, K. J. (2022). ISPE-Endorsed Guidance in Using Electronic Health Records for Comparative Effectiveness Research in COVID-19: Opportunities and Trade-Offs. Clinical Pharmacology and Therapeutics, 112(5), 990-999. https://doi.org/10.1002/cpt.2560

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abstract = "As the scientific research community along with healthcare professionals and decision makers around the world fight tirelessly against the coronavirus disease 2019 (COVID-19) pandemic, the need for comparative effectiveness research (CER) on preventive and therapeutic interventions for COVID-19 is immense. Randomized controlled trials markedly under-represent the frail and complex patients seen in routine care, and they do not typically have data on long-term treatment effects. The increasing availability of electronic health records (EHRs) for clinical research offers the opportunity to generate timely real-world evidence reflective of routine care for optimal management of COVID-19. However, there are many potential threats to the validity of CER based on EHR data that are not originally generated for research purposes. To ensure unbiased and robust results, we need high-quality healthcare databases, rigorous study designs, and proper implementation of appropriate statistical methods. We aimed to describe opportunities and challenges in EHR-based CER for COVID-19-related questions and to introduce best practices in pharmacoepidemiology to minimize potential biases. We structured our discussion into the following topics: (1) study population identification based on exposure status; (2) ascertainment of outcomes; (3) common biases and potential solutions; and (iv) data operational challenges specific to COVID-19 CER using EHRs. We provide structured guidance for the proper conduct and appraisal of drug and vaccine effectiveness and safety research using EHR data for the pandemic. This paper is endorsed by the International Society for Pharmacoepidemiology (ISPE).",

author = "Grammati Sarri and Dimitri Bennett and Thomas Debray and Anouk Deruaz-Luyet and {Soriano Gabarr{\'o}}, Montse and Largent, {Joan A.} and Xiaojuan Li and Wei Liu and Lund, {Jennifer L.} and Moga, {Daniela C.} and Mugdha Gokhale and Rentsch, {Christopher T.} and Xuerong Wen and Chen Yanover and Yizhou Ye and Huifeng Yun and Zullo, {Andrew R.} and Lin, {Kueiyu Joshua}",

note = "Publisher Copyright: {\textcopyright} 2022 The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.",

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Sarri, G, Bennett, D, Debray, T, Deruaz-Luyet, A, Soriano Gabarró, M, Largent, JA, Li, X, Liu, W, Lund, JL, Moga, DC, Gokhale, M, Rentsch, CT, Wen, X, Yanover, C, Ye, Y, Yun, H, Zullo, AR & Lin, KJ 2022, 'ISPE-Endorsed Guidance in Using Electronic Health Records for Comparative Effectiveness Research in COVID-19: Opportunities and Trade-Offs', Clinical Pharmacology and Therapeutics, vol. 112, no. 5, pp. 990-999. https://doi.org/10.1002/cpt.2560

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AU - Bennett, Dimitri

AU - Debray, Thomas

AU - Deruaz-Luyet, Anouk

AU - Soriano Gabarró, Montse

AU - Largent, Joan A.

AU - Li, Xiaojuan

AU - Liu, Wei

AU - Lund, Jennifer L.

AU - Moga, Daniela C.

AU - Gokhale, Mugdha

AU - Rentsch, Christopher T.

AU - Wen, Xuerong

AU - Yanover, Chen

AU - Ye, Yizhou

AU - Yun, Huifeng

AU - Zullo, Andrew R.

AU - Lin, Kueiyu Joshua

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ISPE-Endorsed Guidance in Using Electronic Health Records for Comparative Effectiveness Research in COVID-19: Opportunities and Trade-Offs

Abstract

Bibliographical note

Funding

ASJC Scopus subject areas

UN SDGs

Access to Document

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