학술논문
Ascertainment of vaccination status by self‐report versus source documentation: Impact on measuring COVID‐19 vaccine effectiveness
Document Type
article
Author
Stephenson, Meagan; Olson, Samantha M; Self, Wesley H; Ginde, Adit A; Mohr, Nicholas M; Gaglani, Manjusha; Shapiro, Nathan I; Gibbs, Kevin W; Hager, David N; Prekker, Matthew E; Gong, Michelle N; Steingrub, Jay S; Peltan, Ithan D; Martin, Emily T; Reddy, Raju; Busse, Laurence W; Duggal, Abhijit; Wilson, Jennifer G; Qadir, Nida; Mallow, Christopher; Kwon, Jennie H; Exline, Matthew C; Chappell, James D; Lauring, Adam S; Baughman, Adrienne; Lindsell, Christopher J; Hart, Kimberly W; Lewis, Nathaniel M; Patel, Manish M; Tenforde, Mark W; Investigators, IVY Network
Source
Influenza and Other Respiratory Viruses. 16(6)
Subject
Language
Abstract
BackgroundDuring the COVID-19 pandemic, self-reported COVID-19 vaccination might facilitate rapid evaluations of vaccine effectiveness (VE) when source documentation (e.g., immunization information systems [IIS]) is not readily available. We evaluated the concordance of COVID-19 vaccination status ascertained by self-report versus source documentation and its impact on VE estimates.MethodsHospitalized adults (≥18 years) admitted to 18 U.S. medical centers March-June 2021 were enrolled, including COVID-19 cases and SARS-CoV-2 negative controls. Patients were interviewed about COVID-19 vaccination. Abstractors simultaneously searched IIS, medical records, and other sources for vaccination information. To compare vaccination status by self-report and documentation, we estimated percent agreement and unweighted kappa with 95% confidence intervals (CIs). We then calculated VE in preventing COVID-19 hospitalization of full vaccination (2 doses of mRNA product ≥14 days prior to illness onset) independently using data from self-report or source documentation.ResultsOf 2520 patients, 594 (24%) did not have self-reported vaccination information to assign vaccination group; these patients tended to be more severely ill. Among 1924 patients with both self-report and source documentation information, 95.0% (95% CI: 93.9-95.9%) agreement was observed, with a kappa of 0.9127 (95% CI: 0.9109-0.9145). VE was 86% (95% CI: 81-90%) by self-report data only and 85% (95% CI: 81-89%) by source documentation data only.ConclusionsApproximately one-quarter of hospitalized patients could not provide self-report COVID-19 vaccination status. Among patients with self-report information, there was high concordance with source documented status. Self-report may be a reasonable source of COVID-19 vaccination information for timely VE assessment for public health action.