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COVID-19 Patients & Racial and Ethnic Differences

    Basic Details
    Last Updated
    Monday, March 11, 2024
    Original Posting Date
    Health Outcome(s)
    differences among racial and ethnic groups
    Other Regulatory
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    Regulatory Determination / Use

    The Coronavirus Disease 2019 (COVID-19) was first detected in the United States in January 2020. Early studies indicated a disproportionate burden of COVID-19 infections, hospitalizations, and deaths among racial and ethnic minority groups. Importantly, these early studies were limited in geographic scope, and/or focused only on elderly and higher-risk adults. The COVID-19 pandemic, thus, presented the FDA with a unique opportunity to evaluate race and ethnicity-related data pertaining to COVID-19 testing, hospitalizations, and other outcomes, including disease severity and mortality. FDA’s studies in the Sentinel System sought to expand upon the current understanding of COVID-19-related outcomes among insured adult patients under 65 years old by geographic region over the year-long study period, using Sentinel’s rapid Sentinel Distributed Database (SDD), TriNetX Network, and PCORnet data sources.

    The rapid SDD analysis found up to 42% of insured individuals with COVID-19 had missing race information, and patients with unknown race were younger and healthier. Results also indicated that minoritized individuals with COVID-19 have increased odds of COVID-19 hospitalization, critical COVID-19, and 30-day in-hospital mortality after controlling for baseline differences.

    An analysis conducted in the PCORnet Distributed Data Network identified approximately 580,000 patients with any evidence of COVID-19 and approximately 73,000 with evidence of inpatient COVID-19 between April 2020 and March 2021. Data on race and ethnicity were well-populated in this electronic health record data source, especially compared to claims data sources (<9% of all eligible patients had missing race data). While there were no statistically significant differences in the racial composition of the "all eligible" and "any COVID-19" cohorts, patients of "Black or African American" and "Other" race were disproportionately present in the hospitalized COVID-19 cohort (21.2% vs 14.3% for Black and 9.3 vs 5.9% for Other). Apparent differences in clinical observation and laboratory results existed between racial/ethnic minoritized groups compared to patients of White race and/or Non-Hispanic ethnicity, but interpretation of these findings was difficult due to lack of standardization. Future work should examine to what extent clinical and laboratory data can be used to understand potential racial and ethnic differences in COVID-19.

    This study raised awareness of the extent of missingness of race and ethnicity in administrative claims data used for regulatory purposes. This evaluation of missing race and ethnicity data provoked innovative thinking of approaches to improve the capture of race data in the Sentinel Distributed Database. Building a full picture of the associations between race and ethnicity and COVID-19 outcomes will continue efforts to characterize the full impact of the COVID-19 pandemic. As this study intended to characterize the burden of COVID-19 outcomes, FDA did not take any regulatory action based on these data.

    This project was funded by U.S. Food and Drug Administration (FDA) Office of Minority Health and Health Equity (OMHHE).