Validity of inpatient electronic health record‐based measures of oxygen‐related therapy in the United States: Lessons applicable for studying COVID‐19 endpoints

Author:

Fuller Candace C.1ORCID,Rosen Edward1,Rai Ashish1,Cosgrove Austin1,Miller Karla2,Bright Patricia3,Haffenreffer Katherine1,Poland Russell E.12,Pratt Natasha3,Sands Kenneth12,Shinde Mayura U.1,Platt Richard1,Cocoros Noelle M.1ORCID,Klompas Michael1,Dutcher Sarah K.3ORCID

Affiliation:

1. Department of Population Medicine Harvard Pilgrim Health Care Institute Boston Massachusetts USA

2. HCA Healthcare Nashville Tennessee USA

3. United States Food and Drug Administration Silver Spring Maryland USA

Abstract

AbstractIntroductionDuring the COVID‐19 pandemic, inpatient electronic health records (EHRs) have been used to conduct public health surveillance and assess treatments and outcomes. Invasive mechanical ventilation (MV) and supplemental oxygen (O2) use are markers of severe illness in hospitalized COVID‐19 patients. In a large US system (n = 142 hospitals), we assessed documentation of MV and O2 use during COVID‐19 hospitalization in administrative data versus nursing documentation.MethodsWe identified 319 553 adult hospitalizations with a COVID‐19 diagnosis, February 2020–October 2022, and extracted coded, administrative data for MV or O2. Separately, we developed classification rules for MV or O2 supplementation from semi‐structured nursing documentation. We assessed MV and O2 supplementation in administrative data versus nursing documentation and calculated ordinal endpoints of decreasing COVID‐19 disease severity. Nursing documentation was considered the gold standard in sensitivity and positive predictive value (PPV) analyses.ResultsIn nursing documentation, the prevalence of MV and O2 supplementation among COVID‐19 hospitalizations was 14% and 75%, respectively. The sensitivity of administrative data was 83% for MV and 41% for O2, with both PPVs above 91%. Concordance between sources was 97% for MV (κ = 0.85), and 54% for O2 (κ = 0.21). For ordinal endpoints, administrative data accurately identified intensive care and MV but underestimated hospitalizations with O2 requirements (42% vs. 18%).ConclusionsIn comparison to nursing documentation, administrative data under‐ascertained O2 supplementation but accurately estimated severe endpoints such as MV. Nursing documentation improved ascertainment of O2 among COVID‐19 hospitalizations and can capture oxygen requirements in adults hospitalized with COVID‐19 or other respiratory illnesses.

Funder

U.S. Food and Drug Administration

Publisher

Wiley

Reference12 articles.

1. International Analysis of Electronic Health Records of Children and Youth Hospitalized With COVID-19 Infection in 6 Countries

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3. Endpoints used in phase III randomized controlled trials of treatment options for COVID-19

4. COVID‐19: Developing drugs and biological products for treatment or prevention.U.S. Food and Drug Administration.2021Accessed September 31 2021.https://www.fda.gov/regulatory-information/search-fda-guidance-documents/covid-19-developing-drugs-and-biological-products-treatment-or-prevention

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