{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,9]],"date-time":"2026-05-09T04:10:54Z","timestamp":1778299854430,"version":"3.51.4"},"reference-count":21,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2026,2,18]],"date-time":"2026-02-18T00:00:00Z","timestamp":1771372800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,2,18]],"date-time":"2026-02-18T00:00:00Z","timestamp":1771372800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clin Pharma and Therapeutics"],"published-print":{"date-parts":[[2026,6]]},"abstract":"<jats:p>\n                    Claims\u2010based analyses can suffer from residual and unmeasured confounding due to factors that are poorly captured in claims. Some of these factors may be measured in other data sources, such as in structured fields of electronic health records (EHR), for example, laboratory test results, or in free\u2010text physician notes. We conducted a proof\u2010of\u2010principle study to demonstrate a process for evaluating the potential risk of confounding\u2014factors poorly captured in claims data but measurable in the EHR as part of drug safety surveillance activities. In future practical applications, this approach could be used along with other sensitivity analyses to evaluate potential residual confounding (e.g.,\n                    <jats:italic>E<\/jats:italic>\n                    \u2010values, negative controls). We used claims\u2010EHR linked data from the Mass General Brigham site of the US Food and Drug Administration's (FDA) Sentinel Real World Evidence Data Enterprise. We extracted a cohort that was previously used in a prototypical Sentinel claims\u2010based query that compared initiators of sacubitril\u2010valsartan vs. angiotensin\u2010converting enzyme inhibitors or angiotensin receptor blockers on the risk of angioedema. In this cohort, we used EHR data to characterize angioedema risk factors poorly captured in claims and observed that claims\u2010based proxies balanced most risk factors that were measurable only in EHR data. While quantitative bias analysis methods can be used to adjust for residual confounding using external information on magnitude and direction of bias, this was deemed unnecessary for this example due to the observed balance achieved on risk factors for angioedema measured in the EHR. A robust linked EHR\u2010claims data infrastructure is crucial for routine application of these methods to evaluate and mitigate residual confounding in drug safety surveillance studies.\n                  <\/jats:p>","DOI":"10.1002\/cpt.70236","type":"journal-article","created":{"date-parts":[[2026,2,19]],"date-time":"2026-02-19T03:01:10Z","timestamp":1771470070000},"page":"1460-1465","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Evaluating Unmeasured Confounding Factors in Claims Data Using Linked Electronic Health Records: A Proof\u2010of\u2010Principle Analysis"],"prefix":"10.1002","volume":"119","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9182-304X","authenticated-orcid":false,"given":"Sushama","family":"Kattinakere Sreedhara","sequence":"first","affiliation":[{"name":"Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital Harvard Medical School  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-5709-0849","authenticated-orcid":false,"given":"Haritha S.","family":"Pillai","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital Harvard Medical School  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0299-7273","authenticated-orcid":false,"given":"Rishi J.","family":"Desai","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital Harvard Medical School  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kerry","family":"Ngan","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital Harvard Medical School  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ken","family":"Lai","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital Harvard Medical School  Boston Massachusetts USA"},{"name":"Department of Computational Linguistics Brandeis University  Waltham Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joyce","family":"Lii","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital Harvard Medical School  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0574-2890","authenticated-orcid":false,"given":"Sarah K.","family":"Dutcher","sequence":"additional","affiliation":[{"name":"Center for Drug Evaluation and Research, United States Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5841-4183","authenticated-orcid":false,"given":"Youjin","family":"Wang","sequence":"additional","affiliation":[{"name":"Center for Drug Evaluation and Research, United States Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6733-6914","authenticated-orcid":false,"given":"Jummai","family":"Apata","sequence":"additional","affiliation":[{"name":"Center for Drug Evaluation and Research, United States Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7272-6199","authenticated-orcid":false,"given":"Fang","family":"Tian","sequence":"additional","affiliation":[{"name":"Center for Drug Evaluation and Research, United States Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7202-7435","authenticated-orcid":false,"given":"Ikponmwosa","family":"Osaghae","sequence":"additional","affiliation":[{"name":"Center for Drug Evaluation and Research, United States Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6874-7803","authenticated-orcid":false,"given":"Jiwei","family":"He","sequence":"additional","affiliation":[{"name":"Center for Drug Evaluation and Research, United States Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John G.","family":"Connolly","sequence":"additional","affiliation":[{"name":"Department of Population Medicine Harvard Pilgrim Health Care Institute and Harvard Medical School  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7761-7090","authenticated-orcid":false,"given":"Shirley V.","family":"Wang","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital Harvard Medical School  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2026,2,18]]},"reference":[{"key":"e_1_2_11_1_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.320"},{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1093\/jamia\/ocac153"},{"key":"e_1_2_11_3_1","unstructured":"Key Database Statistics<https:\/\/www.sentinelinitiative.org\/about\/key\u2010database\u2010statistics>. Accessed October 1 2024."},{"key":"e_1_2_11_4_1","unstructured":"Research Data Assistance Center.Pharmacy service type code<https:\/\/resdac.org\/cms\u2010data\/variables\/pharmacy\u2010service\u2010type\u2010code>. Accessed September 30 2025."},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.2979"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41746-021-00542-0"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.70028"},{"key":"e_1_2_11_8_1","unstructured":"Angioedema following Sacubitril\/Valsartan Use in Patients with Heart Failure: A Propensity Score Analysis Part 1<https:\/\/dev.sentinelsystem.org\/projects\/AP\/repos\/sentinel\u2010analytic\u2010packages\/browse?at=refs%2Fheads%2Fcder_mpl2r_wp016>. Accessed 26 January 2004."},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2022.10.033"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1097\/EDE.0000000000000595"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.6058"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaip.2019.12.007"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12911-019-0970-1"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12911-018-0625-7"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/jch.13097"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.7326\/M16-2607"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.2307\/2533848"},{"key":"e_1_2_11_18_1","first-page":"61","article-title":"Accuracy and bias of race\/ethnicity codes in the Medicare Enrollment Database","volume":"26","author":"Waldo D.R.","journal-title":"Health Care Financ. Rev."},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1097\/MLR.0000000000001216"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.2147\/CLEP.S436131"},{"key":"e_1_2_11_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2021.01.008"}],"container-title":["Clinical Pharmacology &amp; Therapeutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpt.70236","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpt.70236","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpt.70236","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,9]],"date-time":"2026-05-09T03:30:26Z","timestamp":1778297426000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/10.1002\/cpt.70236"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,2,18]]},"references-count":21,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2026,6]]}},"alternative-id":["10.1002\/cpt.70236"],"URL":"https:\/\/doi.org\/10.1002\/cpt.70236","archive":["Portico"],"relation":{},"ISSN":["0009-9236","1532-6535"],"issn-type":[{"value":"0009-9236","type":"print"},{"value":"1532-6535","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,2,18]]},"assertion":[{"value":"2025-06-12","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-01-23","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-02-18","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}