{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,15]],"date-time":"2026-04-15T21:52:13Z","timestamp":1776289933893,"version":"3.50.1"},"reference-count":24,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2025,11,9]],"date-time":"2025-11-09T00:00:00Z","timestamp":1762646400000},"content-version":"vor","delay-in-days":8,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100005227","name":"Centers for Medicare and Medicaid Services","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005227","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000738","name":"U.S. Department of Veterans Affairs","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000738","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":[[2025,11]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>The US Food and Drug Administration proposed a five\u2010level disease severity categorization for baseline COVID\u201019 (asymptomatic, mild, moderate, severe, critical).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>We conducted a pilot study aimed to validate the performance of the ICD\u201010\u2010CM diagnosis code for COVID\u201019 (U07.1) and operational definitions (code\u2010based algorithms) for each disease severity category in Medicare administrative data.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials &amp; Methods<\/jats:title>\n                    <jats:p>We sampled 250 community\u2010dwelling beneficiaries aged \u2265\u200918\u2009years with a U07.1 code on an inpatient hospital or ambulatory claim between April 1, 2020 and June 18, 2022. We used stratified sampling based on care setting and COVID\u201019 treatment status and adjusted results using sampling weights. Using medical records as the reference standard, we calculated positive predictive values (PPV) and 95% confidence intervals (CI). We conducted prespecified secondary analyses to improve algorithm performance by using refined disease definitions.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>We received medical records for 190 (77%) beneficiaries. Of these, 171 had a positive SARS\u2010CoV\u20102 test result. The PPV of the COVID\u201019 diagnosis code was 89% (CI: 83%\u201393%) overall, 88% (CI: 80%\u201393%) in the ambulatory setting, and 93% (CI: 82%\u201397%) in the inpatient setting. The operational definition for disease severity varied in performance by severity level and measurement strategy. The best performance was: PPV for asymptomatic and mild combined 69% (CI: 59%\u201377%), PPV for moderate 58% (CI: 34%\u201378%); PPV for severe 42% (CI: 27%\u201359%); and PPV for critical 85% (CI: 57%\u201396%).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>The code, U07.1, reliably identified beneficiaries with COVID\u201019 in both ambulatory and inpatient settings. The operational definition to classify COVID\u201019 disease severity notably improved performance when we implemented selected refinements.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Researchers should consider the moderate performance of the proposed operational definitions when using administrative claims data to assess COVID\u201019 disease severity.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/pds.70252","type":"journal-article","created":{"date-parts":[[2025,11,10]],"date-time":"2025-11-10T07:31:55Z","timestamp":1762759915000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Validation of the US Food and Drug Administration's COVID\u201019 Disease Severity Categorization for Use in Real\u2010World Data"],"prefix":"10.1002","volume":"34","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1272-1502","authenticated-orcid":false,"given":"Silvia","family":"Perez\u2010Vilar","sequence":"first","affiliation":[{"name":"US Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wei","family":"Hua","sequence":"additional","affiliation":[{"name":"US Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-3704-6494","authenticated-orcid":false,"given":"Andrew","family":"Kwist","sequence":"additional","affiliation":[{"name":"Acumen LLC  Burlingame California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-4164-4214","authenticated-orcid":false,"given":"Yuxin","family":"Ma","sequence":"additional","affiliation":[{"name":"Acumen LLC  Burlingame California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Diane","family":"Dong","sequence":"additional","affiliation":[{"name":"US Department of Veterans Affairs  Hines Illinois USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rongping","family":"Zhang","sequence":"additional","affiliation":[{"name":"US Department of Veterans Affairs  Hines Illinois USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yong","family":"Ma","sequence":"additional","affiliation":[{"name":"US Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-4029-0100","authenticated-orcid":false,"given":"Andrea","family":"Chavez","sequence":"additional","affiliation":[{"name":"Acumen LLC  Burlingame California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nina","family":"Huang","sequence":"additional","affiliation":[{"name":"US Department of Veterans Affairs  Hines Illinois USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Virginia","family":"Sheikh","sequence":"additional","affiliation":[{"name":"US Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-1781-2824","authenticated-orcid":false,"given":"Yiyun","family":"Chiang","sequence":"additional","affiliation":[{"name":"Acumen LLC  Burlingame California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cedric","family":"Salone","sequence":"additional","affiliation":[{"name":"US Department of Veterans Affairs  Hines Illinois USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Natalie","family":"Pica","sequence":"additional","affiliation":[{"name":"US Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-3536-3506","authenticated-orcid":false,"given":"Yunfan","family":"Zhu","sequence":"additional","affiliation":[{"name":"Acumen LLC  Burlingame California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Natasha","family":"Pratt","sequence":"additional","affiliation":[{"name":"US Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gita","family":"Nadimpalli","sequence":"additional","affiliation":[{"name":"Acumen LLC  Burlingame California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4622-1859","authenticated-orcid":false,"given":"Suzann","family":"Pershing","sequence":"additional","affiliation":[{"name":"Acumen LLC  Burlingame California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9553-3122","authenticated-orcid":false,"given":"Michael","family":"Wernecke","sequence":"additional","affiliation":[{"name":"Acumen LLC  Burlingame California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7924-8372","authenticated-orcid":false,"given":"Fran E.","family":"Cunningham","sequence":"additional","affiliation":[{"name":"US Department of Veterans Affairs  Hines Illinois USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7469-4047","authenticated-orcid":false,"given":"David J.","family":"Graham","sequence":"additional","affiliation":[{"name":"US Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,11,9]]},"reference":[{"key":"e_1_2_11_2_1","unstructured":"US Department of Health and Human Services US Food and Drug Administration \u201cCOVID\u201019: Developing Drugs and Biological Products for Treatment or Prevention. Draft Guidance for Industry \u201d2021 https:\/\/www.fda.gov\/media\/137926\/download."},{"key":"e_1_2_11_3_1","unstructured":"US Department of Health and Human Services US Food and Drug Administration \u201cReal\u2010World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision\u2010Making for Drug and Biological Products. Draft Guidance for Industry \u201d2021 https:\/\/www.fda.gov\/regulatory\u2010information\/search\u2010fda\u2010guidance\u2010documents\/real\u2010world\u2010data\u2010assessing\u2010electronic\u2010health\u2010records\u2010and\u2010medical\u2010claims\u2010data\u2010support\u2010regulatory."},{"key":"e_1_2_11_4_1","unstructured":"Sentinel Initiative \u201cMaster Protocol Development: COVID\u201019 Natural History \u201d2020 https:\/\/www.sentinelinitiative.org\/methods\u2010data\u2010tools\/methods\/master\u2010protocol\u2010development\u2010covid\u201019\u2010natural\u2010history."},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.5401"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.2147\/CLEP.S335621"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.5436"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12913\u2010023\u201009362\u20102"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2020.20323"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.5537"},{"key":"e_1_2_11_11_1","unstructured":"Centers for Medicare & Medicaid Services \u201cMedicare Program\u2014General Information \u201daccessed August 23 2024 https:\/\/www.cms.gov\/Medicare\/Medicare\u2010General\u2010Information\/MedicareGenInfo\/index."},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/jiaa767"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/jiab515"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1007\/978-94-017-1404-4_5"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/B0-12-369398-5\/00061-X"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1093\/aje\/kwae071"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF01709751"},{"key":"e_1_2_11_18_1","doi-asserted-by":"crossref","unstructured":"S.Baccianella A.Esuli andF.Sebastiani \u201cEvaluation Measures for Ordinal Regression \u201dpresented at the Ninth International Conference on Intelligent Systems Design and Applications Pisa Italy 2009.","DOI":"10.1109\/ISDA.2009.230"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1037\/h0026256"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11336\u2010014\u20109439\u20104"},{"key":"e_1_2_11_21_1","doi-asserted-by":"crossref","unstructured":"E. M.Garry A. R.Weckstein K.Quinto et\u00a0al. \u201cUse of an EHR to Inform an Administrative Data Algorithm to Categorize Inpatient COVID\u201019 Severity \u201dpreprint medRxiv October 5 2021 https:\/\/doi.org\/10.1101\/2021.10.04.21264513.","DOI":"10.1101\/2021.10.04.21264513"},{"key":"e_1_2_11_22_1","unstructured":"Centers for Disease Control and Prevention \u201cRespiratory Virus Hospitalization Surveillance Network (RESP\u2010NET) \u201daccessed October 28 2024 https:\/\/www.cdc.gov\/resp\u2010net\/dashboard\/index.html."},{"key":"e_1_2_11_23_1","unstructured":"US Food and Drug Administration \u201cCOVID\u201019 Test Basics \u201daccessed August 23 2024 https:\/\/www.fda.gov\/consumers\/consumer\u2010updates\/covid\u201019\u2010test\u2010basics."},{"key":"e_1_2_11_24_1","unstructured":"Centers for Disease Control and Prevention \u201cCOVID\u201019. Overview of Testing for SARS\u2010CoV\u20102 \u201daccessed August 23 2024 https:\/\/www.cdc.gov\/covid\/hcp\/testing\/index.html."},{"key":"e_1_2_11_25_1","doi-asserted-by":"publisher","DOI":"10.1128\/spectrum.02525\u201023"}],"container-title":["Pharmacoepidemiology and Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pds.70252","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,11,21]],"date-time":"2025-11-21T08:53:29Z","timestamp":1763715209000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/pds.70252"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,11]]},"references-count":24,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2025,11]]}},"alternative-id":["10.1002\/pds.70252"],"URL":"https:\/\/doi.org\/10.1002\/pds.70252","archive":["Portico"],"relation":{},"ISSN":["1053-8569","1099-1557"],"issn-type":[{"value":"1053-8569","type":"print"},{"value":"1099-1557","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,11]]},"assertion":[{"value":"2025-05-07","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-10-17","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-11-09","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70252"}}