{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,30]],"date-time":"2026-10-30T00:40:27Z","timestamp":1793320827057,"version":"4.5.0"},"reference-count":42,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2020,1,6]],"date-time":"2020-01-06T00:00:00Z","timestamp":1578268800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100007155","name":"Medical Research Council Canada","doi-asserted-by":"publisher","award":["1504916"],"award-info":[{"award-number":["1504916"]}],"id":[{"id":"10.13039\/501100007155","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":[[2020,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>Bayesian hierarchical models (BHMs) have been used to identify adverse drug reactions, allowing information sharing amongst adverse reactions and drugs expected to have similar properties. This study evaluated the use of BHMs in the routine signal detection analyses of potential first\u2010trimester teratogens, where these models have not previously been applied.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Data on 15 058 malformed foetuses exposed to first trimester medications (1995\u20102011) from 13 European congenital anomaly (CA) registries were analysed. The proportion of each CA in women taking a specific medication was compared with the proportion of that CA in all other women in the dataset (55 CAs \u00d7  523 medications). BHMs were grouped by either medications or CAs or by both simultaneously, and the results compared with analysing each medication\u2010CA combination separately and adjusting for multiplicity using a double false discovery rate (FDR) procedure. The proportions of \u201chigh\u2010risk\u201d medications (medications which have been shown to carry a moderate to high risk of foetal malformations) identified as potential signals were compared, as well as the total number of potential signals requiring follow up (the effective workload).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>BHMs identified more high\u2010risk medications than the double FDR method, but the effective workload was larger. A BHM grouping both medications and CAs, for example, identified 23% of high\u2010risk medications compared with 14% by the double FDR; however, there was an increase from 16 to 71 potential signals requiring follow up.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>For comparable effective workloads, BHMs did not outperform the double FDR, which is comparatively straightforward to implement and is therefore recommended for continued use in teratogenic signal detection analyses.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.4948","type":"journal-article","created":{"date-parts":[[2020,1,7]],"date-time":"2020-01-07T06:26:11Z","timestamp":1578378371000},"page":"337-346","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Bayesian hierarchical methods in the detection of potentially teratogenic first\u2010trimester medications"],"prefix":"10.1002","volume":"29","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5709-367X","authenticated-orcid":false,"given":"Alana","family":"Cavadino","sequence":"first","affiliation":[{"name":"Wolfson Institute of Preventive Medicine Queen Mary University of London  London UK"},{"name":"Section of Epidemiology and Biostatistics, School of Population Health The University of Auckland  Auckland New Zealand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Prieto\u2010Merino","sequence":"additional","affiliation":[{"name":"Faculty of Epidemiology &amp; Population Health London School of Hygiene and Tropical Medicine  London UK"},{"name":"Applied Statistics in Medical Research Group Catholic University of Murcia (UCAM)  Murcia Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joan K.","family":"Morris","sequence":"additional","affiliation":[{"name":"Wolfson Institute of Preventive Medicine Queen Mary University of London  London UK"},{"name":"Population Health Research Institute St George's, University of London  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,1,6]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2834.2011.01250.x"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.13056"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.13799"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.3390\/pharmaceutics4040607"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.2165\/11596630-000000000-00000"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF03256796"},{"key":"e_1_2_10_8_1","volume-title":"Bayesian Hierarchical Methods for Detection of Adverse Reactions to Drugs in Large Databases using Hierarchies of Drugs and Adverse Events","author":"Brook M","year":"2011"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/bdra.20775"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/bdra.20779"},{"key":"e_1_2_10_11_1","unstructured":"BakkerMandJongeLd.EUROCAT Special Report: Sources of Information on Medication Use in Pregnancy.2014; Available from:http:\/\/www.eurocat-network.eu\/content\/Special-Report-Medication-Use-In-Pregnancy.pdf."},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/bdra.20780"},{"key":"e_1_2_10_13_1","unstructured":"EUROCATCentral Registry. 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