{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T21:30:46Z","timestamp":1790112646415,"version":"4.0.1"},"reference-count":46,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2020,3,4]],"date-time":"2020-03-04T00:00:00Z","timestamp":1583280000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"French Ministry of Health","award":["PREPS 2014"],"award-info":[{"award-number":["PREPS 2014"]}]},{"name":"French Ministry of Health","award":["0635"],"award-info":[{"award-number":["0635"]}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2020,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objectives<\/jats:title><jats:p>To introduce the methodology of the ALCAPONE project.<\/jats:p><\/jats:sec><jats:sec><jats:title>Background<\/jats:title><jats:p>The French National Healthcare System Database (SNDS), covering 99% of the French population, provides a potentially valuable opportunity for drug safety alert generation. ALCAPONE aimed to assess empirically in the SNDS case\u2010based designs for alert generation related to four health outcomes of interest.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>ALCAPONE used a reference set adapted from observational medical outcomes partnership (OMOP) and Exploring and Understanding Adverse Drug Reactions (EU\u2010ADR) project, with four outcomes\u2014acute liver injury (ALI), myocardial infarction (MI), acute kidney injury (AKI), and upper gastrointestinal bleeding (UGIB)\u2014and positive and negative drug controls. ALCAPONE consisted of four main phases: (1) data preparation to fit the OMOP Common Data Model and select the drug controls; (2) detection of the selected controls via three case\u2010based designs: case\u2010population, case\u2010control, and self\u2010controlled case series, including design variants (varying risk window, adjustment strategy, etc.); (3) comparison of design variant performance (area under the ROC curve, mean square error, etc.); and (4) selection of the optimal design variants and their calibration for each outcome.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Over 2009\u20102014, 5225 cases of ALI, 354\u2009109 MI, 12\u2009633 AKI, and 156\u2009057 UGIB were identified using specific definitions. The number of detectable drugs ranged from 61 for MI to 25 for ALI. Design variants generated more than 50\u2009000 points estimates. Results by outcome will be published in forthcoming papers.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>ALCAPONE has shown the interest of the empirical assessment of pharmacoepidemiological approaches for drug safety alert generation and may encourage other researchers to do the same in other databases.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.4983","type":"journal-article","created":{"date-parts":[[2020,3,5]],"date-time":"2020-03-05T07:19:47Z","timestamp":1583392787000},"page":"993-1000","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Empirical assessment of case\u2010based methods for drug safety alert identification in the French National Healthcare System database (SNDS): Methodology of the ALCAPONE project"],"prefix":"10.1002","volume":"29","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3589-0819","authenticated-orcid":false,"given":"Nicolas H.","family":"Thurin","sequence":"first","affiliation":[{"name":"Bordeaux PharmacoEpi, INSERM CIC1401 Universit\u00e9 de Bordeaux  Bordeaux France"},{"name":"INSERM U1219 Universit\u00e9 de Bordeaux  Bordeaux France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R\u00e9gis","family":"Lassalle","sequence":"additional","affiliation":[{"name":"Bordeaux PharmacoEpi, INSERM CIC1401 Universit\u00e9 de Bordeaux  Bordeaux France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martijn","family":"Schuemie","sequence":"additional","affiliation":[{"name":"Epidemiology Analytics Janssen Research and Development  Titusville New Jersey USA"},{"name":"Observational Health Data Sciences and Informatics (OHDSI)  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marine","family":"P\u00e9nichon","sequence":"additional","affiliation":[{"name":"Bordeaux PharmacoEpi, INSERM CIC1401 Universit\u00e9 de Bordeaux  Bordeaux France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joshua J.","family":"Gagne","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"}]},{"given":"Jeremy A.","family":"Rassen","sequence":"additional","affiliation":[{"name":"Aetion, Inc.  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jacques","family":"Benichou","sequence":"additional","affiliation":[{"name":"Department of Biostatistics and Clinical Research Rouen University Hospital  Rouen France"},{"name":"INSERM U1181  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8687-9092","authenticated-orcid":false,"given":"Alain","family":"Weill","sequence":"additional","affiliation":[{"name":"Caisse Nationale de l'Assurance Maladie  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick","family":"Blin","sequence":"additional","affiliation":[{"name":"Bordeaux PharmacoEpi, INSERM CIC1401 Universit\u00e9 de Bordeaux  Bordeaux France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1212-2817","authenticated-orcid":false,"given":"Nicholas","family":"Moore","sequence":"additional","affiliation":[{"name":"Bordeaux PharmacoEpi, INSERM CIC1401 Universit\u00e9 de Bordeaux  Bordeaux France"},{"name":"INSERM U1219 Universit\u00e9 de Bordeaux  Bordeaux France"},{"name":"CHU de Bordeaux  Bordeaux France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C\u00e9cile","family":"Droz\u2010Perroteau","sequence":"additional","affiliation":[{"name":"Bordeaux PharmacoEpi, INSERM CIC1401 Universit\u00e9 de Bordeaux  Bordeaux France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,3,4]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00228-013-1486-8"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.1836"},{"key":"e_1_2_8_4_1","first-page":"43","article-title":"The EU\u2010ADR project: preliminary results and perspective","volume":"148","author":"Trifiro G","year":"2009","journal-title":"Stud Health Technol Inform."},{"key":"e_1_2_8_5_1","first-page":"25","article-title":"EU\u2010ADR healthcare database network vs. spontaneous reporting system database: preliminary comparison of signal detection","volume":"166","author":"Trifiro G","year":"2011","journal-title":"Stud Health Technol Inform."},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-013-0106-y"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-013-0105-z"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-013-0095-x"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-013-0099-6"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-013-0101-3"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-013-0107-x"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-013-0100-4"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-013-0108-9"},{"key":"e_1_2_8_14_1","first-page":"574","article-title":"Observational health data sciences and informatics (OHDSI): opportunities for observational researchers","volume":"216","author":"Hripcsak G","year":"2015","journal-title":"Stud Health Technol Inform."},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.4233"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-012-0013-7"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.3371"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.2165\/11592140-000000000-00000"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1097\/EDE.0b013e3182a77882"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12916-016-0553-2"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.2174\/1574884708666131111211802"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF03261999"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00228-012-1357-8"},{"key":"e_1_2_8_24_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-013-0097-8"},{"key":"e_1_2_8_25_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-012-0002-x"},{"key":"e_1_2_8_26_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-013-0111-1"},{"key":"e_1_2_8_27_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.12239"},{"key":"e_1_2_8_28_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00228-013-1614-5"},{"key":"e_1_2_8_29_1","doi-asserted-by":"publisher","DOI":"10.1093\/ehjqcco\/qcw004"},{"key":"e_1_2_8_30_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.12807"},{"key":"e_1_2_8_31_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.4640"},{"key":"e_1_2_8_32_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-018-0752-1"},{"key":"e_1_2_8_33_1","doi-asserted-by":"publisher","DOI":"10.1093\/aje\/126.2.356"},{"key":"e_1_2_8_34_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.2302"},{"key":"e_1_2_8_35_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.5925"},{"key":"e_1_2_8_36_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.6977"},{"key":"e_1_2_8_37_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.6936"},{"key":"e_1_2_8_38_1","unstructured":"Observational Health Data Sciences and Informatics.The Book of OHDSI;2019."},{"key":"e_1_2_8_39_1","unstructured":"SchuemieM SoledadC SuchardM TianY SchulerA RyanP HripcsakG. Empirical evaluation of the OHDSI methods library. OHDSI Symposium 2017.https:\/\/www.ohdsi.org\/past-events\/2017-ohdsi-symposium-materials\/."},{"key":"e_1_2_8_40_1","doi-asserted-by":"publisher","DOI":"10.1093\/oxfordjournals.aje.a112220"},{"key":"e_1_2_8_41_1","doi-asserted-by":"publisher","DOI":"10.2307\/2529046"},{"key":"e_1_2_8_42_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.8320"},{"key":"e_1_2_8_43_1","doi-asserted-by":"publisher","DOI":"10.1007\/s002280000190"},{"key":"e_1_2_8_44_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF02333011"},{"key":"e_1_2_8_45_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(98)24034-7"},{"key":"e_1_2_8_46_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2125.1998.00773.x"},{"key":"e_1_2_8_47_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-016-0392-2"}],"container-title":["Pharmacoepidemiology and Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fpds.4983","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pds.4983","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/pds.4983","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pds.4983","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,3]],"date-time":"2023-09-03T15:22:51Z","timestamp":1693754571000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/pds.4983"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,3,4]]},"references-count":46,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2020,9]]}},"alternative-id":["10.1002\/pds.4983"],"URL":"https:\/\/doi.org\/10.1002\/pds.4983","archive":["Portico"],"relation":{},"ISSN":["1053-8569","1099-1557"],"issn-type":[{"value":"1053-8569","type":"print"},{"value":"1099-1557","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,3,4]]},"assertion":[{"value":"2019-06-07","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-02-12","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-03-04","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}