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

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 i...

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Autores principales: Sarri, Grammati, Bennett, Dimitri, Debray, Thomas, Deruaz‐Luyet, Anouk, Soriano Gabarró, Montse, Largent, Joan A., Li, Xiaojuan, Liu, Wei, Lund, Jennifer L., Moga, Daniela C., Gokhale, Mugdha, Rentsch, Christopher T., Wen, Xuerong, Yanover, Chen, Ye, Yizhou, Yun, Huifeng, Zullo, Andrew R., Lin, Kueiyu Joshua
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9087010/
https://www.ncbi.nlm.nih.gov/pubmed/35170021
http://dx.doi.org/10.1002/cpt.2560
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author Sarri, Grammati
Bennett, Dimitri
Debray, Thomas
Deruaz‐Luyet, Anouk
Soriano Gabarró, Montse
Largent, Joan A.
Li, Xiaojuan
Liu, Wei
Lund, Jennifer L.
Moga, Daniela C.
Gokhale, Mugdha
Rentsch, Christopher T.
Wen, Xuerong
Yanover, Chen
Ye, Yizhou
Yun, Huifeng
Zullo, Andrew R.
Lin, Kueiyu Joshua
author_facet Sarri, Grammati
Bennett, Dimitri
Debray, Thomas
Deruaz‐Luyet, Anouk
Soriano Gabarró, Montse
Largent, Joan A.
Li, Xiaojuan
Liu, Wei
Lund, Jennifer L.
Moga, Daniela C.
Gokhale, Mugdha
Rentsch, Christopher T.
Wen, Xuerong
Yanover, Chen
Ye, Yizhou
Yun, Huifeng
Zullo, Andrew R.
Lin, Kueiyu Joshua
author_sort Sarri, Grammati
collection PubMed
description 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).
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spelling pubmed-90870102022-05-10 ISPE‐Endorsed Guidance in Using Electronic Health Records for Comparative Effectiveness Research in COVID‐19: Opportunities and Trade‐Offs Sarri, Grammati Bennett, Dimitri Debray, Thomas Deruaz‐Luyet, Anouk Soriano Gabarró, Montse Largent, Joan A. Li, Xiaojuan Liu, Wei Lund, Jennifer L. Moga, Daniela C. Gokhale, Mugdha Rentsch, Christopher T. Wen, Xuerong Yanover, Chen Ye, Yizhou Yun, Huifeng Zullo, Andrew R. Lin, Kueiyu Joshua Clin Pharmacol Ther Tutorial 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). John Wiley and Sons Inc. 2022-03-11 /pmc/articles/PMC9087010/ /pubmed/35170021 http://dx.doi.org/10.1002/cpt.2560 Text en © 2022 The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle Tutorial
Sarri, Grammati
Bennett, Dimitri
Debray, Thomas
Deruaz‐Luyet, Anouk
Soriano Gabarró, Montse
Largent, Joan A.
Li, Xiaojuan
Liu, Wei
Lund, Jennifer L.
Moga, Daniela C.
Gokhale, Mugdha
Rentsch, Christopher T.
Wen, Xuerong
Yanover, Chen
Ye, Yizhou
Yun, Huifeng
Zullo, Andrew R.
Lin, Kueiyu Joshua
ISPE‐Endorsed Guidance in Using Electronic Health Records for Comparative Effectiveness Research in COVID‐19: Opportunities and Trade‐Offs
title ISPE‐Endorsed Guidance in Using Electronic Health Records for Comparative Effectiveness Research in COVID‐19: Opportunities and Trade‐Offs
title_full ISPE‐Endorsed Guidance in Using Electronic Health Records for Comparative Effectiveness Research in COVID‐19: Opportunities and Trade‐Offs
title_fullStr ISPE‐Endorsed Guidance in Using Electronic Health Records for Comparative Effectiveness Research in COVID‐19: Opportunities and Trade‐Offs
title_full_unstemmed ISPE‐Endorsed Guidance in Using Electronic Health Records for Comparative Effectiveness Research in COVID‐19: Opportunities and Trade‐Offs
title_short ISPE‐Endorsed Guidance in Using Electronic Health Records for Comparative Effectiveness Research in COVID‐19: Opportunities and Trade‐Offs
title_sort ispe‐endorsed guidance in using electronic health records for comparative effectiveness research in covid‐19: opportunities and trade‐offs
topic Tutorial
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9087010/
https://www.ncbi.nlm.nih.gov/pubmed/35170021
http://dx.doi.org/10.1002/cpt.2560
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