{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T15:03:16Z","timestamp":1789657396127,"version":"4.0.1"},"reference-count":19,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2026,4,14]],"date-time":"2026-04-14T00:00:00Z","timestamp":1776124800000},"content-version":"vor","delay-in-days":13,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,4,1]],"date-time":"2026-04-01T00:00:00Z","timestamp":1775001600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100000038","name":"U.S. Food and Drug Administration","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000038","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2026,4]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>The U.S. Food and Drug Administration (FDA) defined disease severity criteria to assist clinical development of medical products for management of COVID\u201019. These definitions were translated to code\u2010based algorithms for use in real\u2010world data. We validated the algorithms' performance in ambulatory settings at three regional integrated healthcare delivery systems contributing data to FDA's Sentinel System.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We identified cohorts of individuals \u2265\u200918\u2009years that met the algorithms' criteria for mild, moderate, and severe COVID\u201019 at incident COVID\u201019 diagnosis or positive SARS\u2010CoV\u20102 test, and separately, at incident COVID\u201019 treatment, from January 2022 through April 2023. We validated the algorithms via chart review of a random sample to calculate positive predictive values (PPVs) and 95% CIs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The algorithms identified 33\u2009071 patients at COVID\u201019 diagnosis or positive test; 26\u2009985 mild (49 chart reviewed),\u00a05180 moderate (55 reviewed), and 906 severe (56 reviewed). A total of 4512 patients were identified at COVID\u201019 treatment; 3474 mild (56 reviewed), 848 moderate (60 reviewed), and 190 severe (46 reviewed). The PPVs (1) at COVID\u201019 diagnosis or positive test were: mild 57% (95% CI: 43%\u201371%), moderate 58% (95% CI: 45%\u201371%), and severe 54% (95% CI: 41%\u201367%), and (2) at COVID\u201019 treatment: mild 57% (95% CI: 44%\u201370%), moderate 70% (95% CI: 58%\u201382%) and severe 72% (95% CI: 59%\u201385%).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The algorithms had low\u2010to\u2010moderate performance in classifying COVID\u201019 severity in ambulatory settings, depending on assessment at diagnosis or treatment. Researchers should consider the performance of the algorithm when using real\u2010world data to assess COVID\u201019 severity.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/pds.70363","type":"journal-article","created":{"date-parts":[[2026,4,14]],"date-time":"2026-04-14T22:46:50Z","timestamp":1776206810000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Identifying\n                    <scp>COVID<\/scp>\n                    \u201019 Disease Severity in Real\u2010World Data: Implications for Medical Product Effectiveness Studies"],"prefix":"10.1002","volume":"35","author":[{"given":"Mayura U.","family":"Shinde","sequence":"first","affiliation":[{"name":"Department of Population Medicine Harvard Pilgrim Health Care Institute  Boston Massachusetts USA"},{"name":"Harvard Medical School  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katherine","family":"Shapiro","sequence":"additional","affiliation":[{"name":"Department of Population Medicine Harvard Pilgrim Health Care Institute  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Hou","sequence":"additional","affiliation":[{"name":"Department of Population Medicine Harvard Pilgrim Health Care Institute  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin","family":"Coughlin","sequence":"additional","affiliation":[{"name":"Department of Population Medicine Harvard Pilgrim Health Care Institute  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aaron M.","family":"Madow","sequence":"additional","affiliation":[{"name":"Department of Population Medicine Harvard Pilgrim Health Care Institute  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fatma M.","family":"Shebl","sequence":"additional","affiliation":[{"name":"Office of Surveillance and Epidemiology Center for Drug Evaluation and Research, U.S. Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patricia","family":"Bright","sequence":"additional","affiliation":[{"name":"Office of Surveillance and Epidemiology Center for Drug Evaluation and Research, U.S. Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0481-6168","authenticated-orcid":false,"given":"Gaia","family":"Pocobelli","sequence":"additional","affiliation":[{"name":"Kaiser Permanente Washington Health Research Institute  Seattle Washington USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James D.","family":"Ralston","sequence":"additional","affiliation":[{"name":"Kaiser Permanente Washington Health Research Institute  Seattle Washington USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vina F.","family":"Graham","sequence":"additional","affiliation":[{"name":"Kaiser Permanente Washington Health Research Institute  Seattle Washington USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Margaret B.","family":"Nolan","sequence":"additional","affiliation":[{"name":"HealthPartners Institute  Bloomington Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ingrid A.","family":"Binswanger","sequence":"additional","affiliation":[{"name":"Kaiser Permanente Colorado, Aurora CO, Colorado Permanente Medical Group  Denver Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Natasha","family":"Pratt","sequence":"additional","affiliation":[{"name":"Office of Surveillance and Epidemiology Center for Drug 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