Classifying COVID-19 hospitalizations in epidemiology cohort studies: The C4R study

作者：Elizabeth C. Oelsner, Akshaya Krishnaswamy, Rafail Rustamov, Pallavi Balte, Tauqeer Ali, Norrina B. Allen, Howard Andrews, Pramod Anugu, Alexander Arynchyn, Lori A. Bateman, Jianwen Cai, Harry Chang, Lukui Chen, Mitchell S.V. Elkind, James S. Floyd, Kelley Pettee Gabriel, Sina A. Gharib, José D. Gutiérrez, Karen Hinckley Stukovsky, Virginia J. Howard, Carmen R. Isasi, Lauren Jager, Ling Jin, Suzanne E. Judd, Alka M. Kanaya, Namratha R. Kandula, Maureen R. Kelly, Sadiya S. Khan, Anna Kucharska‐Newton, Joyce Lee, Emily B. Levitan, Cora E. Lewis, Barry J. Make, Kimberly Malloy, Jennifer J. Manly, D. Mauger, Yuan‐I Min, Joanne M. Murabito, Charles Murphy, Arnita F. Norwood, George O'connor, Victor E. Ortega, Ashmi A Patel, Amber Pirzada, Elizabeth A. Regan, Kimberly Ring, Wayne D. Rosamond, David A. Schwartz, James M. Shikany, Daniela Sotres‐Alvarez, Cheryl Tarlton, Janis Tse, Elman M. Urbina Meneses, Maya Vankineni, Sally E. Wenzel, Prescott G. Woodruff, Vanessa Xanthakis, Joseph Yang, Neil A. Zakai, Ying Zhang, Wendy S. Post · 发表于：PLoS ONE · 年份：2025 · DOI：10.1371/journal.pone.0316198 · 被引用次数：5 · 研究领域：COVID-19 Clinical Research Studies、Sepsis Diagnosis and Treatment、COVID-19 and healthcare impacts

RATIONALE: Robust COVID-19 outcomes classification is important for ongoing epidemiology research on acute and post-acute COVID-19 conditions. Protocolized medical record review is an established method to validate endpoints for clinical trials and cardiovascular epidemiology cohorts; however, a protocol to adjudicate hospitalizations for COVID-19 among epidemiology cohorts was lacking. OBJECTIVES: We developed a protocol to ascertain and adjudicate hospitalized COVID-19 across a meta-cohort of 14 US prospective cohort studies. This report describes the first three years of protocol implementation (October 1, 2020-October 1, 2023) and evaluates its repeatability and performance compared to classification by administrative codes. METHODS: The protocol was adapted from cohort approaches to clinical cardiovascular events ascertainment and adjudication. Potential COVID-19 hospitalizations and deaths were identified by self-/proxy-report and, in some cases, active surveillance. Medical records were requested from hospitals and adjudicated for COVID-19 outcomes by clinically trained personnel according to a standardized rubric. Inter-rater agreement was assessed. The sensitivity and specificity of discharge diagnosis codes was compared to adjudicated diagnoses. MEASUREMENTS AND MAIN RESULTS: The study obtained medical records for 1,167 potential COVID-19 hospitalizations, which underwent protocolized adjudication. Adjudication confirmed COVID-19 infection was present for 1,030 (88%...