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ISPE‐Endorsed Guidance in Using Electronic Health Records for Comparative Effectiveness Research in COVID‐19: Opportunities and Trade‐Offs
Author(s) -
Sarri Grammati,
Bennett Dimitri,
Debray Thomas,
DeruazLuyet 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
Publication year - 2022
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.2560
Subject(s) - comparative effectiveness research , pandemic , medicine , pharmacoepidemiology , health care , covid-19 , psychological intervention , data science , alternative medicine , computer science , nursing , infectious disease (medical specialty) , disease , pathology , political science , medical prescription , law
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).