{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T22:51:12Z","timestamp":1791240672098,"version":"4.1.0"},"reference-count":22,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2023,9,10]],"date-time":"2023-09-10T00:00:00Z","timestamp":1694304000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["R01AR074436"],"award-info":[{"award-number":["R01AR074436"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["R01HD109335"],"award-info":[{"award-number":["R01HD109335"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["R61HD105619"],"award-info":[{"award-number":["R61HD105619"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["R33HD105619"],"award-info":[{"award-number":["R33HD105619"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["UL1TR003017"],"award-info":[{"award-number":["UL1TR003017"]}],"id":[{"id":"10.13039\/100000002","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":[[2024,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>Given limited information available on real\u2010world data (RWD) sources with pediatric populations, this study describes features of globally available RWD sources for pediatric pharmacoepidemiologic research.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>An online questionnaire about pediatric RWD sources and their attributes and capabilities was completed by members and affiliates of the International Society for Pharmacoepidemiology and representatives of nominated databases. All responses were verified by database representatives and summarized.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Of 93 RWD sources identified, 55 unique pediatric RWD sources were verified, including data from Europe (47%), United States (38%), multiregion (7%), Asia\u2010Pacific (5%), and South America (2%). Most databases had nationwide coverage (82%), contained electronic health\/medical records (47%) and\/or administrative claims data (42%) and were linkable to other databases (65%). Most (71%) had limited outside access (e.g., by approval or through local collaborators); only 10 (18%) databases were publicly available. Six databases (11%) reported having &gt;20 million pediatric observations. Most (91%) included children of all ages (birth until 18th birthday) and contained outpatient medication data (93%), while half (49%) contained inpatient medication data. Many databases captured vaccine information for children (71%), and one\u2010third had regularly updated data on pediatric height (31%) and weight (33%). Other pediatric data attributes captured include diagnoses and comorbidities (89%), lab results (58%), vital signs (55%), devices (55%), imaging results (42%), narrative patient histories (35%), and genetic\/biomarker data (22%).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>This study provides an overview with key details about diverse databases that allow researchers to identify fit\u2010for\u2010purpose RWD sources suitable for pediatric pharmacoepidemiologic research.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/pds.5695","type":"journal-article","created":{"date-parts":[[2023,9,10]],"date-time":"2023-09-10T20:33:45Z","timestamp":1694378025000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Overview of global\n                    <scp>real\u2010world<\/scp>\n                    data sources for pediatric pharmacoepidemiologic research"],"prefix":"10.1002","volume":"33","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7177-9777","authenticated-orcid":false,"given":"Gerold T.","family":"Wharton","sequence":"first","affiliation":[{"name":"Office of Pediatric Therapeutics US Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudia","family":"Becker","sequence":"additional","affiliation":[{"name":"Basel Pharmacoepidemiology Unit, Division of Clinical Pharmacy &amp; Epidemiology, Department of Pharmaceutical Sciences University Basel  Basel Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8387-9342","authenticated-orcid":false,"given":"Dimitri","family":"Bennett","sequence":"additional","affiliation":[{"name":"Global Evidence and Outcomes, Safety Pharmacoepidemiology, Takeda Development Center Americas, Inc.  Cambridge Massachusetts USA"},{"name":"Perelman School of Medicine University of Pennsylvania  Philadelphia Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4572-0987","authenticated-orcid":false,"given":"Mehmet","family":"Burcu","sequence":"additional","affiliation":[{"name":"Department of Epidemiology Merck &amp; Co., Inc.  Rahway New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Greta","family":"Bushnell","sequence":"additional","affiliation":[{"name":"Department of Biostatistics and Epidemiology, Rutgers School of Public Health, New Brunswick, NJ, USA; Rutgers Center for Pharmacoepidemiology and Treatment Science Institute for Health, Health Care Policy and Aging Research  New Brunswick New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carmen","family":"Ferrajolo","sequence":"additional","affiliation":[{"name":"Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology  Naples Italy"},{"name":"Department of Experimental Medicine, Section of Pharmacology, \"L. Donatelli\" University of Campania \"Luigi Vanvitelli\"  Naples Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3352-8480","authenticated-orcid":false,"given":"Sigal","family":"Kaplan","sequence":"additional","affiliation":[{"name":"Department Pharmacoepidemiology Teva Pharmaceutical Industries Ltd  Netanya Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2617-6357","authenticated-orcid":false,"given":"Ann W.","family":"McMahon","sequence":"additional","affiliation":[{"name":"Office of Pediatric Therapeutics US Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naimisha","family":"Movva","sequence":"additional","affiliation":[{"name":"EpidStrategies A Division of ToxStrategies Inc  Rockville Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sudha R.","family":"Raman","sequence":"additional","affiliation":[{"name":"Department of Population Health Sciences Duke University School of Medicine  Durham North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2633-6587","authenticated-orcid":false,"given":"Oliver","family":"Scholle","sequence":"additional","affiliation":[{"name":"Department of Clinical Epidemiology Leibniz Institute for Prevention Research and Epidemiology \u2013 BIPS  Bremen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mina","family":"Suh","sequence":"additional","affiliation":[{"name":"EpidStrategies A Division of ToxStrategies Inc  Rockville Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jenny W.","family":"Sun","sequence":"additional","affiliation":[{"name":"Safety Surveillance Research Pfizer Inc.  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