{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T10:10:59Z","timestamp":1791886259208,"version":"4.3.4"},"reference-count":23,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T00:00:00Z","timestamp":1787097600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T00:00:00Z","timestamp":1787097600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100009633","name":"Eunice Kennedy Shriver National Institute of Child Health and Human Development","doi-asserted-by":"publisher","award":["R01HD107759"],"award-info":[{"award-number":["R01HD107759"]}],"id":[{"id":"10.13039\/100009633","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100009633","name":"Eunice Kennedy Shriver National Institute of Child Health and Human Development","doi-asserted-by":"publisher","award":["R01HD107772"],"award-info":[{"award-number":["R01HD107772"]}],"id":[{"id":"10.13039\/100009633","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000065","name":"National Institute of Neurological Disorders and Stroke","doi-asserted-by":"publisher","award":["NIH T90HD118400"],"award-info":[{"award-number":["NIH T90HD118400"]}],"id":[{"id":"10.13039\/100000065","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":[[2026,9]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>Congenital malformations are important outcomes when evaluating medication safety in pregnancy. However, the accuracy of claims\u2010based algorithms for identifying organ\u2010specific malformations remains understudied. We validated algorithms for four malformation groups: urinary tract, genital, gastrointestinal, and musculoskeletal.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods<\/jats:title>\n                    <jats:p>Using the Mass General Brigham (MGB, 2007\u20132020) and Stanford Medicine (2016\u20132023) databases, we identified infants with potential malformations of interest based on diagnosis and procedure codes within 90\u2009days of birth. A total of 150 cases were sampled for each malformation group. Positive predictive values (PPV) were estimated to quantify the validity of the algorithms, separately by site and by International Classification of Diseases (ICD) coding system.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>For MGB ICD\u20109, MGB ICD\u201010, and Stanford ICD\u201010 algorithms, respectively, PPVs were 100%, 98.0%, and 95.8% for urinary tract malformations; 98.0%, 95.9%, and 93.8% for genital malformations; 76.0%, 78.0%, and 76.0% for gastrointestinal malformations; and 85.4%, 84.0%, and 62.0% for musculoskeletal malformations. False positives were primarily attributed to suspected malformations that were later ruled out and to broader or inaccurate coding for diagnoses that were not major malformations.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Claims\u2010based algorithms demonstrated high PPVs for urinary tract and genital malformations and moderate for gastrointestinal malformations, but there was variation in musculoskeletal PPVs between the institutions with different patient populations.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/pds.70461","type":"journal-article","created":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T23:50:02Z","timestamp":1787183402000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Validation of Claims\u2010Based Algorithms for Identifying Congenital Urinary Tract, Genital, Gastrointestinal, and Musculoskeletal Malformations"],"prefix":"10.1002","volume":"35","author":[{"ORCID":"https:\/\/orcid.org\/0009-0004-6282-1362","authenticated-orcid":false,"given":"Kelly","family":"Fung","sequence":"first","affiliation":[{"name":"Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine Brigham and Women's Hospital and Harvard Medical School  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8213-1319","authenticated-orcid":false,"given":"Stephanie A.","family":"Leonard","sequence":"additional","affiliation":[{"name":"Division of Maternal\u2010Fetal Medicine and Obstetrics, Department of Obstetrics and Gynecology Stanford University School of Medicine  Stanford California USA"},{"name":"Department of Anesthesiology, Perioperative and Pain Medicine Stanford University School of Medicine  Stanford California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5805-8430","authenticated-orcid":false,"given":"Krista F.","family":"Huybrechts","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine Brigham and Women's Hospital and Harvard Medical School  Boston Massachusetts USA"},{"name":"Department of Epidemiology Harvard T. H. Chan School of Public Health  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1458-7642","authenticated-orcid":false,"given":"Sonia","family":"Hernandez\u2010Diaz","sequence":"additional","affiliation":[{"name":"Department of Epidemiology Harvard T. H. Chan School of Public Health  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian T.","family":"Bateman","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology, Perioperative and Pain Medicine Stanford University School of Medicine  Stanford California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2623-2726","authenticated-orcid":false,"given":"Loreen","family":"Straub","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine Brigham and Women's Hospital and Harvard Medical School  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4374-9949","authenticated-orcid":false,"given":"Ayesha","family":"Sujan","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology, Perioperative and Pain Medicine Stanford University School of Medicine  Stanford California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3541-3724","authenticated-orcid":false,"given":"Kathryn J.","family":"Gray","sequence":"additional","affiliation":[{"name":"Division of Maternal\u2010Fetal Medicine, Department of Obstetrics and Gynecology University of Washington School of Medicine  Seattle Washington USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kylie","family":"Andersen","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology, Perioperative and Pain Medicine Brigham and Women's Hospital  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric Y.","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology, Perioperative and Pain Medicine Brigham and Women's Hospital  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kareem","family":"El\u2010Tayeb","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology, Perioperative and Pain Medicine Brigham and Women's Hospital  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Murka","family":"Jeancharles","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology, Perioperative and Pain Medicine Brigham and Women's Hospital  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Allison A.","family":"Mootz","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology and Pain Management University of Texas Southwestern Medical Center  Dallas Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-5626-3769","authenticated-orcid":false,"given":"Amanda 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