{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,7,30]],"date-time":"2025-07-30T10:04:50Z","timestamp":1753869890292,"version":"3.41.2"},"reference-count":12,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2025,1,13]],"date-time":"2025-01-13T00:00:00Z","timestamp":1736726400000},"content-version":"vor","delay-in-days":12,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"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":[[2025,1]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>To characterize select laboratory tests ordered versus reported for patients diagnosed with COVID\u201019 in administrative healthcare and commercial laboratory data.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Among patients with an outpatient COVID\u201019 diagnosis claim in HealthVerity data (01\/01\/2021\u201312\/31\/2022), this study described baseline characteristics and descriptively compared SARS\u2010CoV\u20102 diagnostic tests and liver function tests from administrative healthcare (insurance claims and hospital billing data) and commercial laboratories, overall and by code type (e.g., CPT, LOINC). Select liver function tests were also described by method\u2010specific and methodless LOINC.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Among 214\u2009998 patients with COVID\u201019, 46.1% had a SARS\u2010CoV\u20102 molecular diagnostic test recorded within 7\u2009days of diagnosis (in either administrative or laboratory data); 44.5% had a corresponding CPT in medical claims, while only 10.0% had a corresponding LOINC in laboratory data. In contrast, the six most common liver function tests (albumin, aspartate aminotransferase, total protein, alkaline phosphatase, alanine aminotransferase, and total bilirubin) were identified in 55.7%\u201356.6% of patients via LOINC, but only in 3.2%\u20134.2% via CPT claims. Of the total count of select liver function tests performed in the laboratory data, 99.7% of aspartate aminotransferase, 96.1% of direct bilirubin, and 82.9% of lactate dehydrogenase were reported by methodless LOINC rather than method\u2010specific LOINC.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Important differences were identified between orders for SARS\u2010CoV\u20102 diagnostic tests and liver function tests, as well as missingness of LOINC method, highlighting challenges related to completeness of laboratory data in real\u2010world data sources. These challenges underscore a need to improve data quality when considering the utility of laboratory data for research.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.70094","type":"journal-article","created":{"date-parts":[[2025,1,14]],"date-time":"2025-01-14T04:01:48Z","timestamp":1736827308000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Characterization of <scp>SARS<\/scp>\u2010<scp>CoV<\/scp>\u20102 Diagnostic Tests and Liver Function Tests Among Patients With <scp>COVID<\/scp>\u201019 Diagnosed in Outpatient Settings Using Administrative Healthcare Data and Data From Commercial Laboratories"],"prefix":"10.1002","volume":"34","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4665-5769","authenticated-orcid":false,"given":"Ayad K.","family":"Ali","sequence":"first","affiliation":[{"name":"Aetion Inc.  New York New York USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aidan","family":"Baglivo","sequence":"additional","affiliation":[{"name":"Aetion Inc.  New York New York USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Priya","family":"Govil","sequence":"additional","affiliation":[{"name":"Aetion Inc.  New York New York USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6009-6839","authenticated-orcid":false,"given":"Liza R.","family":"Gibbs","sequence":"additional","affiliation":[{"name":"Aetion Inc.  New York New York USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3231-9951","authenticated-orcid":false,"given":"Marie C.","family":"Bradley","sequence":"additional","affiliation":[{"name":"Office of Medical Policy, Center for Drug Evaluation and Research U.S. Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9162-1405","authenticated-orcid":false,"given":"Keith E.","family":"Campbell","sequence":"additional","affiliation":[{"name":"Systemic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD), Center for Devices and Radiological Health (CDRH) U.S. Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2331-3053","authenticated-orcid":false,"given":"Aloka","family":"Chakravarty","sequence":"additional","affiliation":[{"name":"Office of the Commissioner U.S. Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4104-394X","authenticated-orcid":false,"given":"Tamar","family":"Lasky","sequence":"additional","affiliation":[{"name":"Office of the Commissioner U.S. Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Victoria","family":"Derbyshire","sequence":"additional","affiliation":[{"name":"Systemic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD), Center for Devices and Radiological Health (CDRH) U.S. Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5871-1599","authenticated-orcid":false,"given":"Elizabeth M.","family":"Garry","sequence":"additional","affiliation":[{"name":"Aetion Inc.  New York New York USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,1,13]]},"reference":[{"key":"e_1_2_11_2_1","unstructured":"LOINC \u201cLogical Observation Identifiers Names and Codes (LOINC) \u201d(2023) https:\/\/loinc.org\/history\/. LOINC Release History."},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1093\/jamia\/ocab289"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1093\/jamia\/ocac072"},{"key":"e_1_2_11_5_1","first-page":"447","article-title":"Correctness of Voluntary LOINC Mapping for Laboratory Tests in Three Large Institutions","volume":"2010","author":"Lin M. C.","year":"2010","journal-title":"American Medical Informatics Association Annual Symposium Proceedings"},{"key":"e_1_2_11_6_1","first-page":"611","article-title":"Automated Mapping of Real\u2010World Oncology Laboratory Data to LOINC","volume":"2021","author":"Kelly J.","year":"2021","journal-title":"American Medical Informatics Association Annual Symposium Proceedings"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1093\/jamia\/ocac215"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1097\/MLR.0000000000000996"},{"key":"e_1_2_11_9_1","unstructured":"Assistant Secretary for Planning and Evaluation (ASPE) \u201cSHIELD\u2014Standardization of Lab Data to Enhance Patient\u2010Centered Outcomes Research and Value\u2010Based Care \u201d(June 2019) https:\/\/aspe.hhs.gov\/shield\u2010standardization\u2010lab\u2010data\u2010enhance\u2010patient\u2010centered\u2010outcomes\u2010research\u2010value\u2010based\u2010care.U.S. Department of Health and Human Services."},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.329"},{"key":"e_1_2_11_11_1","unstructured":"Centers for Disease Control and Prevention (CDC) \u201cStrengthening Clinical Laboratories \u201d(November 2018) https:\/\/www.cdc.gov\/csels\/dls\/strengthening\u2010clinical\u2010labs.html."},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1373\/jalm.2016.021634"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1089\/dis.2006.9.122"}],"container-title":["Pharmacoepidemiology and Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pds.70094","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,4,21]],"date-time":"2025-04-21T02:52:44Z","timestamp":1745203964000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/pds.70094"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,1]]},"references-count":12,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2025,1]]}},"alternative-id":["10.1002\/pds.70094"],"URL":"https:\/\/doi.org\/10.1002\/pds.70094","archive":["Portico"],"relation":{},"ISSN":["1053-8569","1099-1557"],"issn-type":[{"type":"print","value":"1053-8569"},{"type":"electronic","value":"1099-1557"}],"subject":[],"published":{"date-parts":[[2025,1]]},"assertion":[{"value":"2024-05-01","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-12-23","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-01-13","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70094"}}