{"doc_desc":{"title":"Etude longitudinale sur des patients \u00e2g\u00e9s de 0 \u00e0 15 ans hospitalis\u00e9s au moins 3 jours ayant re\u00e7u au moins un m\u00e9dicament : risque d\u2019\u00e9v\u00e9nements ind\u00e9sirables m\u00e9dicamenteux associ\u00e9s \u00e0 la prescription hors AMM ou sans AMM","idno":"FRESH-PEF39007-fr","producers":[{"name":"Kim An NGUYEN","affiliation":"UNIVERSITE CLAUDE BERNARD LYON 1"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF39007-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"39007"},{"agency":"FReSH","code":"FRESH-PEF39007"}]},"title":"Etude longitudinale sur des patients \u00e2g\u00e9s de 0 \u00e0 15 ans hospitalis\u00e9s au moins 3 jours ayant re\u00e7u au moins un m\u00e9dicament : risque d\u2019\u00e9v\u00e9nements ind\u00e9sirables m\u00e9dicamenteux associ\u00e9s \u00e0 la prescription hors AMM ou sans AMM","alternate_title":"EREMI"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Behrouz;KASSAI-KOUPAI","firstname":"Behrouz","lastname":"KASSAI-KOUPAI","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01502ca60","role":"organisation id"},{"title":"SIREN","uri":"266900273","role":"organisation id"}],"email":"behrouz.kassai-koupai@chu-lyon.fr","affiliationName":"HOSPICES CIVILS DE LYON (HCL)","PILabo":"Hospices Civils de Lyon (HCL) \/ Clinical Investigation Centre Hospices Civils de Lyon \/Inserm EPICIME (Epidemiology, Pharmacology, Clinical Research and Medical information, Mother and Child) UMR 5558\/CNRS","isContact":true}],"oth_id":[{"name":"CIC P\u00e9diatrique - H\u00f4pital Femme-M\u00e8re-Enfant, Hospices Civils de Lyon (HCL) \/ CIC p\u00e9diatrique - H\u00f4pital Robert Debr\u00e9, Assistance publique \u2013 H\u00f4pitaux de Paris (AP-HP)","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"HOSPICES CIVILS DE LYON (HCL)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01502ca60","role":"sponsor id"},{"title":"SIREN","uri":"266900273","role":"sponsor id"}],"role":"sponsor"},{"name":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00pg5jh14","role":"sponsor id"},{"title":"SIREN","uri":"267500452","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"AGENCE NATIONALE DE SECURITE DU MEDICAMENT ET DES PRODUITS DE SANTE (ANSM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01g80gk13"},{"title":"SIREN","uri":"180036113"}]}]},"distribution_statement":{"contact":[{"name":"Behrouz;KASSAI-KOUPAI","lastname":"KASSAI-KOUPAI","firstname":"Behrouz","type":"contact","email":"behrouz.kassai-koupai@chu-lyon.fr","affiliationName":"HOSPICES CIVILS DE LYON (HCL)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/01502ca60","role":"organisation id","title":"ROR"},{"uri":"266900273","role":"organisation id","title":"SIREN"}]},{"name":"Kim An;NGUYEN","lastname":"NGUYEN","firstname":"Kim An","type":"contact","email":"kim-an.nguyen@chu-lyon.fr","affiliationName":"UNIVERSITE CLAUDE BERNARD LYON 1","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/029brtt94","role":"organisation id","title":"ROR"},{"uri":"196917744","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"m\u00e9dicament"},{"keyword":"prescription"},{"keyword":"EIM"},{"keyword":"\u00e9pisodes ind\u00e9sirables m\u00e9dicamenteux"},{"keyword":"effet ind\u00e9sirable"},{"keyword":"Hospitalisation"},{"keyword":"autorisation de mise sur le march\u00e9"},{"keyword":"AMM"},{"keyword":"enfant"},{"keyword":"adolescent"}],"topics":[{"topic":"P\u00e9diatrie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/bf8aaaac-ddee-41cd-bb8a-c5a63de3fcbd"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D010372"}]},{"topic":"Causes externes de morbidit\u00e9 ou de mortalit\u00e9","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/850137482","title":"CIM-11"}]},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"Comparer, chez les patients \u00e2g\u00e9s de 0 \u00e0 15 ans hospitalis\u00e9s au moins 3 jours, la probabilit\u00e9 de survenue d'un \u00e9v\u00e8nement ind\u00e9sirable m\u00e9dicamenteux (EIM) apr\u00e8s prescription d\u2019un m\u00e9dicament ayant l\u2019AMM versus la probabilit\u00e9 de survenue d'un EIM apr\u00e8s prescription d\u2019un m\u00e9dicament hors\/sans AMM Objectifs secondaires : \u2022Comparer la proportion de patients ayant au moins un EIM parmi les patients ayant une prescription d\u2019au moins un m\u00e9dicament hors\/sans AMM avec la proportion de patients ayant au moins un EIM parmi les patients ayant une prescription de m\u00e9dicaments ayant tous l\u2019AMM. \u2022D\u00e9crire, en terme d'AMM et d'indications, les m\u00e9dicaments prescrits par groupe d'\u00e2ge p\u00e9diatriques. \u2022Identifier les facteurs influen\u00e7ant le risque de survenue d\u2019EIM apr\u00e8s prescription d\u2019un m\u00e9dicament. \u2022Estimer la gravit\u00e9 et l\u2018\u00e9vitabilit\u00e9 des EIM","abstract":"","coll_dates":[{"start":"2013-01-01","end":"2016-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Masculin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n          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\"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002675\"\n            }\n        },\n        {\n            \"value\": \"Enfance (6 \u00e0 12 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        },\n        {\n            \"value\": \"Adolescence (13 \u00e0 18 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000293\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"\u2022Patients hospitalis\u00e9s de 0 \u00e0 < 15 ans \u2022Dur\u00e9e d\u2019hospitalisation d\u2019au moins 3 jours (> 48 heures) \u2022Ayant re\u00e7u au moins un m\u00e9dicament\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es 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