{"doc_desc":{"title":"Registre des Malformations cong\u00e9nitales de l'\u00eele de la R\u00e9union (registre \u00e9valu\u00e9 par le Comit\u00e9 d'Evaluation des Registres 2012-2020)","idno":"FRESH-PEF231-fr","producers":[{"name":"Hanitra RANDRIANAIVO","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE LA REUNION"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF231-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"231"},{"agency":"FReSH","code":"FRESH-PEF231"}]},"title":"Registre des Malformations cong\u00e9nitales de l'\u00eele de la R\u00e9union (registre \u00e9valu\u00e9 par le Comit\u00e9 d'Evaluation des Registres 2012-2020)","alternate_title":"REMACOR"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"B\u00e9n\u00e9dicte;NATIVEL","PILabo":"Registre des Malformations de la R\u00e9union","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE LA REUNION","extlink":[{"title":"","uri":"","role":"pi 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(INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"sponsor id"},{"title":"SIREN","uri":"180036048","role":"sponsor id"}],"role":"sponsor"},{"name":"SANTE PUBLIQUE FRANCE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00dfw9p58","role":"sponsor id"},{"title":"SIREN","uri":"130022338","role":"sponsor id"}],"role":"sponsor"},{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE LA REUNION","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/004dan487","role":"sponsor id"},{"title":"SIREN","uri":"200030013","role":"sponsor id"}],"role":"sponsor"},{"name":"","extlink":[],"role":"sponsor"}],"funding_agencies":[{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261"},{"title":"SIREN","uri":"180036048"}]},{"name":"SANTE PUBLIQUE FRANCE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00dfw9p58"},{"title":"SIREN","uri":"130022338"}]},{"name":"AGENCE REGIONALE DE SANTE","extlink":[]},{"name":"","extlink":[]}]},"distribution_statement":{"contact":[{"name":"B\u00e9n\u00e9dicte;NATIVEL","email":"benedicte.bertaut-nativel@chu-reunion.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE LA REUNION","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/004dan487","role":"organisation id","title":"ROR"},{"uri":"200030013","role":"organisation id","title":"SIREN"}]},{"name":"Hanitra;RANDRIANAIVO","email":"hanitra.randrianaivo@chu-reunion.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE LA REUNION","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/004dan487","role":"organisation id","title":"ROR"},{"uri":"200030013","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"anomalies cong\u00e9nitales"},{"keyword":"diagnostic pr\u00e9natal"},{"keyword":"alerte"},{"keyword":"facteurs de risques reprotoxiques"},{"keyword":"t\u00e9ratog\u00e8nes"},{"keyword":"Base de donn\u00e9es"},{"keyword":"\u00e9pid\u00e9miologie"},{"keyword":"surveillance"},{"keyword":"g\u00e9n\u00e9tique"}],"topics":[{"topic":"Certaines maladies infectieuses ou parasitaires","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1435254666","title":"CIM-11"}]},{"topic":"D\u00e9terminants comportementaux : Addictions","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques : Pr\u00e9dispositions g\u00e9n\u00e9tiques","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux : Autres","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux : Alimentation","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques : Emploi","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"1. Assurer la surveillance \u00e9pid\u00e9miologique des anomalies cong\u00e9nitales dans la population r\u00e9unionnaise (d\u00e9termination de la pr\u00e9valence et la r\u00e9partition) et l'identification des facteurs de risque des malformations (g\u00e8ne, environnement, m\u00e9dicaments et toxiques) ; avec un objectif d'alerte face \u00e0 d'\u00e9ventuels agents t\u00e9ratog\u00e8nes (ex : m\u00e9dicament, exposition aux pesticides, accident industriel), au niveau local, national et international. En cas de d\u00e9tection de clusters de malformations ou en cas de surveillance-alerte d\u2019une augmentation de la pr\u00e9valence dans le temps d\u2019une malformation donn\u00e9e, des investigations compl\u00e9mentaires sont r\u00e9alis\u00e9es ( v\u00e9rifications diagnostiques, temporelles et spatiales) avec dans un second temps une recherche de facteurs de risque particuliers. 2. Evaluer en population l'impact des actions de sant\u00e9 publique: - L'\u00e9valuation du d\u00e9pistage pr\u00e9natal des malformations est un objectif fondamental du registre, avec une participation dans le domaine de m\u00e9decine p\u00e9rinatale et des pratiques obst\u00e9tricales locales. - La mise en pratique des actions de pr\u00e9vention et de leur \u00e9valuation sont \u00e9galement importantes, comme pour la pr\u00e9vention primaire des anomalies de fermeture du tube neural par suppl\u00e9mentation p\u00e9riconceptionnelle en acide folique. 3. Identification d\u2019\u00e9ventuels nouveaux syndromes et apport d\u2019\u00e9l\u00e9ments nouveaux pour le conseil g\u00e9n\u00e9tique des familles : mode de transmission, h\u00e9t\u00e9rog\u00e9n\u00e9it\u00e9 g\u00e9n\u00e9tique, facteur de susceptibilit\u00e9 g\u00e9n\u00e9tique.","abstract":"","coll_dates":[{"start":"2002-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['La R\u00e9union']","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Masculin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"F\u00e9minin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Nouveau-n\u00e9 (naissance \u00e0 28j)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007231\"\n            }\n        },\n        {\n            \"value\": \"Nourrisson (28j \u00e0 2 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007223\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Le Registre recense les cas de malformations isol\u00e9es, les syndromes polymalformatifs et  les anomalies chromosomiques parmi les naissances vivantes, les mort-n\u00e9s (de 22 semaines d\u2019am\u00e9norrh\u00e9e ou plus), ainsi que les Interruptions M\u00e9dicales de Grossesse quel qu\u2019en soit l\u2019\u00e2ge gestationnel. Sont inclues dans le registre:  Les malformations cong\u00e9nitales diagnostiqu\u00e9es en ant\u00e9natal ou en postnatal jusqu'\u00e0 la fin de la premi\u00e8re ann\u00e9e de vie.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es socio-d\u00e9mographiques']","quality_statement":{"standards":[{"name":"['Codage CIM10 pour les malformations et les maladies\/ Codage ATC pour les m\u00e9dicaments']","committee":"","governance":""}],"other_quality_statement":"['1) V\u00e9rification et d\u00e9tection d\u2019\u00e9ventuels doublons lors du recueil. 2) V\u00e9rifications des diff\u00e9rents param\u00e8tres d\u2019inclusion : Dans les populations cibl\u00e9es : o Les naissances vivantes o Les interruptions m\u00e9dicales de grossesse quel que soit le terme o Les morts f\u0153tales in utero, > 22 SA Inclusion des : o Malformations isol\u00e9es ou syndrome polymalformatif, avec caryotype normal ou anormal o Anomalies cong\u00e9nitales diagnostiqu\u00e9es en ant\u00e9natal ou en postnatal jusqu\u2019\u00e0 un an o R\u00e9sident du d\u00e9partement Crit\u00e8res d\u2019exclusion o Les anomalies mineures (liste Eurocat : Minor anomalies) o Diagnostic r\u00e9alis\u00e9 apr\u00e8s 1 an o Non r\u00e9sident 3) V\u00e9rification du diagnostic par au moins 2 sources. 4) V\u00e9rification de la concordance des donn\u00e9es lors de la saisie informatique sur logiciel EDMP. 5) R\u00e9trocontr\u00f4le des donn\u00e9es suite \u00e0 l\u2019envoi de la base de donn\u00e9es \u00e0 EUROCAT\/JRC.']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nEv\u00e9nements de sant\u00e9\/mortalit\u00e9"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":""}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}"],"research_instrument":"Acc\u00e8s libre","sources":[{"sourceCitation":{"titlStmt":{"titl":""},"holdings":"","notes":{"subject":"source purpose","value":""}},"srcOrig":["Base m\u00e9dico-administrative"]}],"target_sample_size":"[1000-10000[ individus","response_rate":"2002-2016: 6342 2016 : 470"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Registre de morbidit\u00e9"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Acc\u00e8s r\u00e9serv\u00e9\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Acc\u00e8s aux donn\u00e9es individuelles anonymis\u00e9es possible, sur demande.","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"03-01-2011","lastUpdatedAuto":null,"lastUpdatedManual":"11-07-2018","isContributorPI":"Non","contributorName":"Hanitra RANDRIANAIVO","contributorAffiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE LA REUNION","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)","Public (France)","Public (France)"],"otherFundingAgentType":["","","",""]},"sponsor":{"sponsorType":["Public (France)","Public (France)","Public (France)","Public (France)"],"otherSponsorType":["","","",""]},"governance":{"committee":"Oui"},"collaborations":{"networkConsortium":"Oui"},"theme":{"complementaryInformation":"","RareDiseases":"Oui"},"activeFollowUp":{"isActiveFollowUp":"Oui","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Une surveillance continue des anomalies cong\u00e9nitales sur le d\u00e9partement est possible gr\u00e2ce \u00e0 un recueil actif par la collectrice : \u2022 soit par signalement en collaboration \u00e9troite avec l\u2019ensemble des sources cit\u00e9es ci-dessous. \u2022 soit par recherche active sur les listes Q obtenus par le DIM, les comptes rendus des r\u00e9unions des Centres de Diagnostics Pr\u00e9natal ou encore la recherche \u00e0 partir des plannings de chirurgie.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Oui"},"geographicalCoverage":{"geoDetail":"Population r\u00e9sidant dans le d\u00e9partement de la R\u00e9union"},"dataTypes":{"clinicalDataDetails":"Poids de l'enfant, Type de naissance, Zygotie, Date du diagnostic ant\u00e9natal, Malformations","biologicalDataDetails":"","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[""]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}