@article{e081a5d4d0614b85bd6bc7346986aaad,
title = "Ascertainment of vaccination status by self-report versus source documentation: Impact on measuring COVID-19 vaccine effectiveness",
abstract = "Background: During 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. Methods: Hospitalized 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. Results: Of 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. Conclusions: Approximately 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.",
keywords = "COVID-19, concordance, registry, self-report, vaccine effectiveness",
author = "{IVY Network Investigators} and Meagan Stephenson and Olson, {Samantha M.} and Self, {Wesley H.} and Ginde, {Adit A.} and Mohr, {Nicholas M.} and Manjusha Gaglani and Shapiro, {Nathan I.} and Gibbs, {Kevin W.} and Hager, {David N.} and Prekker, {Matthew E.} and Gong, {Michelle N.} and Steingrub, {Jay S.} and Peltan, {Ithan D.} and Martin, {Emily T.} and Raju Reddy and Busse, {Laurence W.} and Abhijit Duggal and Wilson, {Jennifer G.} and Nida Qadir and Christopher Mallow and Kwon, {Jennie H.} and Exline, {Matthew C.} and Chappell, {James D.} and Lauring, {Adam S.} and Adrienne Baughman and Lindsell, {Christopher J.} and Hart, {Kimberly W.} and Lewis, {Nathaniel M.} and Patel, {Manish M.} and Tenforde, {Mark W.}",
note = "Funding Information: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Wesley H. Self reports grant funding from CDC for this work, grants and consultant fees from Merck outside this work, and consultant fees from Aerpio Pharmaceuticals outside this work. Adit A. Ginde reports grant support from NIH, DOD, and investigator initiated grant support from AbbVie and Faron Pharmaceuticals, all outside of this work. Jonathan D. Casey reports a grant (N23HL153584) from the National Institutes of Health (NIH). D. Clark Files reports consultant fees from Cytovale and membership on a Medpace Data Safety Monitoring Board (DSMB). David N. Hager reports salary support from Incyte Corporation, EMPACT Precision Medicine, and the Marcus Foundation. Michelle N. Gong reports grant support from NIH and the Agency for Healthcare Research and Quality (AHRQ) and fees for participating on a DSMB for Regeneron and for participating on a scientific advisory panel for Philips Healthcare. Daniel J. Henning reports consulting fees from Cytovale and Opticyte. Ithan D. Peltan reports grants from NIH and Janssen Pharmaceuticals and institutional fees from Asahi Kasei Pharma and from Regeneron. Samuel M. Brown reports fees from Hamilton for chairing a DSMB and institutional fees from Faron, Sedana, and Janssen; grants from Sedana, Janssen, NIH, and the Department of Defense (DoD); book royalties from Oxford University and Brigham Young University; and personal fees from New York University for service on a DSMB. Emily T. Martin reports personal fees from Pfizer for unrelated work and a grant from Merck for unrelated work. Akram Khan reports grants from United Therapeutics, Johnson & Johnson, 4D Medical, Lung LLC, and Reata Pharmaceuticals. Steven Y. Chang was a speaker for La Jolla Pharmaceuticals and a Consultant for PureTech Health. Jennie H. Kwon reports grant support from NIH. Matthew C. Exline reports talks on nutrition in COVID pneumonia at APEN conference sponsored by Abbott Labs. Natasha Halasa reports grants from Sanofi and Quidel. James D. Chappell reports a grant from the National Center for Advancing Translational Sciences, NIH. Adam S. Lauring reports consultant fees from Sanofi and fees from Roche for membership on a trial steering committee. Carlos G. Grijalva reports consultant fees from Pfizer, Merck, and Sanofi‐Pasteur and grants from Campbell Alliance/Syneos Health, NIH, the Food and Drug Administration, AHRQ, and Sanofi. Todd W. Rice reports personal fees from Cumberland Pharmaceuticals, Inc., as the Director of Medical Affairs; consultant fees from Cytovale, Inc.; and DSMB membership fees from Sanofi. Christopher J. Lindsell reports grants from NIH, DoD, and the Marcus Foundation; organizational contract fees from bioMerieux, Endpoint LLC, and Entegrion, Inc.; and a patent issued to Cincinnati Children's Hospital Medical Center for risk stratification in sepsis and septic shock. No other potential conflicts of interest were disclosed. Funding Information: This research was supported in part by an appointment to the Research Participation Program at the Centers for Disease Control and Prevention administered by the Oak Ridge Institute for Science and Education through an interagency agreement between the U.S. Department of Energy and CDC. Funding Information: Primary funding for this study was provided by the US Centers for Disease Control and Prevention (75D30121F00002). The REDCap data tool was supported by a Clinical and Translational Science Award (UL1 TR002243) from the National Center for Advancing Translational Sciences. J.H.K. is supported by the National Institute of Allergy and Infectious Diseases, National Institutes of Health (award 1K23AI137321). Dr. Self received grant/contract funding from CDC to perform this work. Funding information Publisher Copyright: {\textcopyright} 2022 The Authors. Influenza and Other Respiratory Viruses published by John Wiley & Sons Ltd. This article has been contributed to by U.S. Government employees and their work is in the public domain in the USA.",
year = "2022",
month = nov,
doi = "10.1111/irv.13023",
language = "English",
volume = "16",
pages = "1101--1111",
journal = "Influenza and other Respiratory Viruses",
issn = "1750-2640",
number = "6",
}