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Categorization of COVID-19 severity to determine mortality risk.
Garry, Elizabeth M; Weckstein, Andrew R; Quinto, Kenneth; Bradley, Marie C; Lasky, Tamar; Chakravarty, Aloka; Leonard, Sandy; Vititoe, Sarah E; Easthausen, Imaani J; Rassen, Jeremy A; Gatto, Nicolle M.
  • Garry EM; Aetion, Inc., New York, New York, USA.
  • Weckstein AR; Aetion, Inc., New York, New York, USA.
  • Quinto K; Office of Medical Policy, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Bradley MC; Division of Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Lasky T; Office of the Commissioner, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Chakravarty A; Office of the Commissioner, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Leonard S; Partnerships and RWD, HealthVerity, Philadelphia, Pennsylvania, USA.
  • Vititoe SE; Aetion, Inc., New York, New York, USA.
  • Easthausen IJ; Aetion, Inc., New York, New York, USA.
  • Rassen JA; Aetion, Inc., New York, New York, USA.
  • Gatto NM; Aetion, Inc., New York, New York, USA.
Pharmacoepidemiol Drug Saf ; 31(7): 721-728, 2022 07.
Article in English | MEDLINE | ID: covidwho-1772832
ABSTRACT

PURPOSE:

Algorithms for classification of inpatient COVID-19 severity are necessary for confounding control in studies using real-world data.

METHODS:

Using Healthverity chargemaster and claims data, we selected patients hospitalized with COVID-19 between April 2020 and February 2021, and classified them by severity at admission using an algorithm we developed based on respiratory support requirements (supplemental oxygen or non-invasive ventilation, O2/NIV, invasive mechanical ventilation, IMV, or NEITHER). To evaluate the utility of the algorithm, patients were followed from admission until death, discharge, or a 28-day maximum to report mortality risks and rates overall and by stratified by severity. Trends for heterogeneity in mortality risk and rate across severity classifications were evaluated using Cochran-Armitage and Logrank trend tests, respectively.

RESULTS:

Among 118 117 patients, the algorithm categorized patients in increasing severity as NEITHER (36.7%), O2/NIV (54.3%), and IMV (9.0%). Associated mortality risk (and 95% CI) was 11.8% (11.6-12.0%) overall and increased with severity [3.4% (3.2-3.5%), 11.5% (11.3-11.8%), 47.3% (46.3-48.2%); p < 0.001]. Mortality rate per 1000 person-days (and 95% CI) was 15.1 (14.9-15.4) overall and increased with severity [5.7 (5.4-6.0), 14.5 (14.2-14.9), 32.7 (31.8-33.6); p < 0.001].

CONCLUSION:

As expected, we observed a positive association between the algorithm-defined severity on admission and 28-day mortality risk and rate. Although performance remains to be validated, this provides some assurance that this algorithm may be used for confounding control or stratification in treatment effect studies.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Type of study: Experimental Studies / Prognostic study Limits: Humans Language: English Journal: Pharmacoepidemiol Drug Saf Journal subject: Epidemiology / Drug Therapy Year: 2022 Document Type: Article Affiliation country: Pds.5436

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Type of study: Experimental Studies / Prognostic study Limits: Humans Language: English Journal: Pharmacoepidemiol Drug Saf Journal subject: Epidemiology / Drug Therapy Year: 2022 Document Type: Article Affiliation country: Pds.5436