{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T02:04:45Z","timestamp":1782785085368,"version":"3.54.5"},"reference-count":20,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2021,6,11]],"date-time":"2021-06-11T00:00:00Z","timestamp":1623369600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100000038","name":"U.S. Food and Drug Administration","doi-asserted-by":"publisher","award":["HHSF223201400030I"],"award-info":[{"award-number":["HHSF223201400030I"]}],"id":[{"id":"10.13039\/100000038","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000038","name":"U.S. Food and Drug Administration","doi-asserted-by":"publisher","award":["HHSF22301002T"],"award-info":[{"award-number":["HHSF22301002T"]}],"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":[[2021,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>To develop and validate an International Classification of Diseases, 10th Revision, Clinical Modification (ICD\u201010\u2010CM)\u2010based algorithm to identify cases of stillbirth using electronic healthcare data.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We conducted a retrospective study using claims data from three Data Partners (healthcare systems and insurers) in the Sentinel Distributed Database. Algorithms were developed using ICD\u201010\u2010CM diagnosis codes to identify potential stillbirths among females aged 12\u201355\u2009years between July 2016 and June 2018. A random sample of medical charts (<jats:italic>N<\/jats:italic>\u00a0=\u2009169) was identified for chart abstraction and adjudication. Two physician adjudicators reviewed potential cases to determine whether a stillbirth event was definite\/probable, the date of the event, and the gestational age at delivery. Positive predictive values (PPVs) were calculated for the algorithms. Among confirmed cases, agreement between the claims data and medical charts was determined for the outcome date and gestational age at stillbirth.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of the 110 potential cases identified, adjudicators determined that 54 were stillbirth events. Criteria for the algorithm with the highest PPV (82.5%; 95% CI, 70.9%\u201391.0%) included the presence of a diagnosis code indicating gestational age \u226520\u2009weeks and occurrence of either &gt;1 stillbirth\u2010related code or no other pregnancy outcome code (i.e., livebirth, spontaneous abortion, induced abortion) recorded on the index date. We found \u226590% agreement within 7\u2009days between the claims data and medical charts for both the outcome date and gestational age at stillbirth.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Our results suggest that electronic healthcare data may be useful for signal detection of medical product exposures potentially associated with stillbirth.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.5300","type":"journal-article","created":{"date-parts":[[2021,6,5]],"date-time":"2021-06-05T06:39:23Z","timestamp":1622875163000},"page":"1175-1183","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":19,"title":["Validation of an <scp>ICD<\/scp>\u201010\u2010based algorithm to identify stillbirth in the Sentinel System"],"prefix":"10.1002","volume":"30","author":[{"given":"Susan E.","family":"Andrade","sequence":"first","affiliation":[{"name":"The Meyers Primary Care Institute, a joint endeavor of the University of Massachusetts Medical School, Reliant Medical Group, and Fallon Health University of Massachusetts Medical School  Worcester Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mayura","family":"Shinde","sequence":"additional","affiliation":[{"name":"Department of Population Medicine Harvard Pilgrim Health Care Institute and Harvard Medical School  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tiffany A.","family":"Moore Simas","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology University of Massachusetts Medical School\/UMass Memorial Health Care  Worcester Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven T.","family":"Bird","sequence":"additional","affiliation":[{"name":"Office of Surveillance and Epidemiology Center for Drug Evaluation and Research, Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4430-798X","authenticated-orcid":false,"given":"Justin","family":"Bohn","sequence":"additional","affiliation":[{"name":"Department of Population Medicine Harvard Pilgrim Health Care Institute and Harvard Medical School  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin","family":"Haynes","sequence":"additional","affiliation":[{"name":"Department of Scientific Affairs HealthCore, Inc.  Wilmington Delaware USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lockwood G.","family":"Taylor","sequence":"additional","affiliation":[{"name":"Office of Surveillance and Epidemiology Center for Drug Evaluation and Research, Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julianne R.","family":"Lauring","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology University of Massachusetts Medical School\/UMass Memorial Health Care  Worcester Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erin","family":"Longley","sequence":"additional","affiliation":[{"name":"Community Health Care Family Medicine Residency  Tacoma Washington USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cheryl N.","family":"McMahill\u2010Walraven","sequence":"additional","affiliation":[{"name":"CVS Health Clinical Trial Services, Part of the CVS Health Family of Companies  Blue Bell Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Connie M.","family":"Trinacty","sequence":"additional","affiliation":[{"name":"Kaiser Permanente Center for Integrated Health Care Research Hawaii and Office of Public Health Studies University of Hawai'i Manoa  Honolulu Hawaii USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cassandra","family":"Saphirak","sequence":"additional","affiliation":[{"name":"The Meyers Primary Care Institute, a joint endeavor of the University of Massachusetts Medical School, Reliant Medical Group, and Fallon Health University of Massachusetts Medical School  Worcester Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher","family":"Delude","sequence":"additional","affiliation":[{"name":"The Meyers Primary Care Institute, a joint endeavor of the University of Massachusetts Medical School, Reliant Medical Group, and Fallon Health University of Massachusetts Medical School  Worcester Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandra","family":"DeLuccia","sequence":"additional","affiliation":[{"name":"Department of Population Medicine Harvard Pilgrim Health Care Institute and Harvard Medical School  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tancy","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Population Medicine Harvard Pilgrim Health Care Institute and Harvard Medical School  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David V.","family":"Cole","sequence":"additional","affiliation":[{"name":"Department of Population Medicine Harvard Pilgrim Health Care Institute and Harvard Medical School  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nina","family":"DiNunzio","sequence":"additional","affiliation":[{"name":"Department of Population Medicine Harvard Pilgrim Health Care Institute and Harvard Medical School  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Autumn","family":"Gertz","sequence":"additional","affiliation":[{"name":"Department of Population Medicine Harvard Pilgrim Health Care Institute and Harvard Medical School  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elnara","family":"Fazio\u2010Eynullayeva","sequence":"additional","affiliation":[{"name":"Department of Population Medicine Harvard Pilgrim Health Care Institute and Harvard Medical School  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Danijela","family":"Stojanovic","sequence":"additional","affiliation":[{"name":"Office of Surveillance and Epidemiology Center for Drug Evaluation and Research, Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,6,11]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.3743"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0067405"},{"key":"e_1_2_11_4_1","unstructured":"KawaiAT AndradeSE ZichittellaL et al. 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