{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T03:01:09Z","timestamp":1790650869952,"version":"4.1.0"},"reference-count":12,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2018,7,10]],"date-time":"2018-07-10T00:00:00Z","timestamp":1531180800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2019,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Change\u2010point analysis (CPA) is a powerful method to analyse pharmacovigilance data but it has never been used on the disproportionality metric.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To optimize signal detection investigating the interest of time\u2010series analysis in pharmacovigilance and the benefits of combining CPA with the proportional reporting ratio (PRR).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We investigated the couple benfluorex and aortic valve incompetence (AVI) using the French National Pharmacovigilance and EudraVigilance databases: CPA was applied on monthly counts of reports and the lower bound of monthly computed PRR (PRR\u2010). We stated a CPA hypothesis that the substance\u2010event combination is more likely to be a signal when the 2 following criteria are fulfilled: PRR\u2010 is greater than 1 with at least 5 cases, and CPA method detects at least 2 successive change points of PRR\u2010 which made consecutively increasing segments. We tested this hypothesis by 95 test cases identified from a drug safety reference set and 2 validated signals from EudraVigilance database: CPA was applied on PRR\u2010.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>For benfluorex and AVI, change points detected by CPA on PRR\u2010 were more meaningful compared with monthly counts of reports: More change points detected and detected earlier. In the reference set, 14 positive controls satisfied CPA hypothesis, 6 positive controls only met first requirements, 3 negative controls only met first requirement, and 2 validated signals satisfied CPA hypothesis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The combination of CPA and PRR represents a significant advantage in detecting earlier signals and reducing false\u2010positive signals. This approach should be confirmed in further studies.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/pds.4613","type":"journal-article","created":{"date-parts":[[2018,7,11]],"date-time":"2018-07-11T02:02:47Z","timestamp":1531274567000},"page":"370-376","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Benefits of combining change\u2010point analysis with disproportionality analysis in pharmacovigilance signal detection"],"prefix":"10.1002","volume":"28","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2794-5322","authenticated-orcid":false,"given":"Nhung T.H.","family":"Trinh","sequence":"first","affiliation":[{"name":"Inserm UMR 1153, Obstetrical, Perinatal and Pediatric Epidemiology Research Team, Research Center for Epidemiology and Biostatistics Sorbonne Paris Cit\u00e9 (CRESS) Paris Descartes University  Paris France"},{"name":"Adverse Events and incidents Department\u2014Surveillance Division Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 (ANSM)  Saint Denis France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elodie","family":"Sol\u00e9","sequence":"additional","affiliation":[{"name":"Adverse Events and incidents Department\u2014Surveillance Division Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 (ANSM)  Saint Denis France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mehdi","family":"Benkebil","sequence":"additional","affiliation":[{"name":"Adverse Events and incidents Department\u2014Surveillance Division Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 (ANSM)  Saint Denis France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,7,10]]},"reference":[{"key":"e_1_2_10_2_1","unstructured":"Council for international organizations of medical sciences (CIOMS) Practical Aspects of Signal Detection in Pharmacovigilance: Report of CIOMS Working Group VIII.2010."},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.677"},{"key":"e_1_2_10_4_1","unstructured":"Eudravigilance Expert Working Group.Guideline on the use of statistical signal detection methods in the Eudravigilance data analysis system.2008; Available from:http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Regulatory_and_procedural_guideline\/2009\/11\/WC500011434.pdf."},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-015-0289-5"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1136\/amiajnl-2011-000793"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.3783"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.medmal.2014.01.005"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-013-0097-8"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-013-0108-9"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2013.24"},{"key":"e_1_2_10_12_1","unstructured":"TaylorWA.Change\u2010point analysis: A powerful new tool for detecting changes[cited 2017 May]; Available from:http:\/\/www.variation.com\/cpa\/tech\/changepoint.html."},{"key":"e_1_2_10_13_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.4613","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pds.4613","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,13]],"date-time":"2023-09-13T22:13:21Z","timestamp":1694643201000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/pds.4613"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,7,10]]},"references-count":12,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2019,3]]}},"alternative-id":["10.1002\/pds.4613"],"URL":"https:\/\/doi.org\/10.1002\/pds.4613","archive":["Portico"],"relation":{},"ISSN":["1053-8569","1099-1557"],"issn-type":[{"value":"1053-8569","type":"print"},{"value":"1099-1557","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,7,10]]},"assertion":[{"value":"2017-10-02","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-06-04","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-07-10","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}