{"doc_desc":{"title":"Registre des Handicaps de l'Enfant et Observatoire Perinatal (registre qualifi\u00e9 2010-2013) de l'Is\u00e8re et des deux Savoie","idno":"FRESH-PEF168-fr","producers":[{"name":"Christine CANS","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE GRENOBLE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF168-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"168"},{"agency":"FReSH","code":"FRESH-PEF168"}]},"title":"Registre des Handicaps de l'Enfant et Observatoire Perinatal (registre qualifi\u00e9 2010-2013) de l'Is\u00e8re et des deux Savoie","alternate_title":"RHEOP"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Christine;CANS","PILabo":"CHU de \/ Service d'information et informatique m\u00e9dical","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE GRENOBLE","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"100952798","role":"pi id"},{"title":"SIREN","uri":"263800302","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"","isContact":"Non"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"DEPARTEMENT DE L ISERE","extlink":[{"title":"SIREN","uri":"223800012","role":"sponsor id"}],"role":"sponsor"},{"name":"DEPARTEMENT DE LA SAVOIE","extlink":[{"title":"SIREN","uri":"227300019","role":"sponsor id"}],"role":"sponsor"},{"name":"DEPARTEMENT DE LA HAUTE SAVOIE","extlink":[{"title":"SIREN","uri":"227400017","role":"sponsor id"}],"role":"sponsor"},{"name":"UNIVERSITE GRENOBLE ALPES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02rx3b187","role":"sponsor id"},{"title":"SIREN","uri":"130026081","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"DEPARTEMENT DE L ISERE","extlink":[{"title":"SIREN","uri":"223800012"}]},{"name":"DEPARTEMENT DE LA HAUTE SAVOIE","extlink":[{"title":"SIREN","uri":"227400017"}]},{"name":"DEPARTEMENT DE LA SAVOIE","extlink":[{"title":"SIREN","uri":"227300019"}]},{"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"}]}]},"distribution_statement":{"contact":[{"name":"","type":"contact"}]},"study_info":{"keywords":[{"keyword":"mortinatalit\u00e9 et Interruptions m\u00e9dicales de grossessed\u00e9ficiences s\u00e9v\u00e8res de l'enfant"}],"topics":[{"topic":"Gyn\u00e9cologie et obst\u00e9trique","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/7de64596-5b0d-4977-8f98-b982ff2ec17d"},{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/284ca20c-beb4-4abe-99fa-ef4513358bad"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D006176"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D009774"}]},{"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"}]}],"purpose":"Dans le domaine de la sant\u00e9 publique: (1) surveiller l'\u00e9volution de la pr\u00e9valence des d\u00e9ficiences s\u00e9v\u00e8res de l'enfant sur une base g\u00e9ographique (trois d\u00e9partements \u00e0 partir de 2005) (2) surveiller l'\u00e9volution des taux de mortinatalit\u00e9 et plus particuli\u00e8rement de la pr\u00e9valence des interruptions de grossesse pour motif m\u00e9dical (IMG) sur la m\u00eame base g\u00e9ographique (3) d\u00e9crire les prises en charge \u00e9ducatives et m\u00e9dicales (4) aider \u00e0 la planification des besoins , afin d'assurer une prise en charge optimale de ces enfants Dans le domaine de la recherche: (1) susciter des enqu\u00eates analytiques sp\u00e9cifiques \u00e0 chaque type de d\u00e9ficience, ou portant sur les d\u00e9ficiences associ\u00e9es (2) identifier les \u00e9tiologies des d\u00e9ficiences et des \u00e9v\u00e8nements p\u00e9rinatals graves (3) Collecter de l'information sur les \u00e9v\u00e8nements p\u00e9rinatals pouvant \u00eatre en relation avec la survenue d'un handicap","abstract":"","coll_dates":[{"start":"1991-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Auvergne Rh\u00f4ne-Alpes']","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            \"value\": \"Enfance (6 \u00e0 12 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Versant d\u00e9ficience : Tous les enfants \u00e2g\u00e9s de moins 7 ans porteurs d'au moins une d\u00e9ficience s\u00e9v\u00e8re principale et r\u00e9sidents dans un des d\u00e9partements Is\u00e8re, Savoie ou Haute-Savoie.  Versant p\u00e9rinatal : \u00e9v\u00e8nements p\u00e9rinataux graves comme les cas de mortinatalit\u00e9 et d'interruption de grossesse survenant chaque ann\u00e9e pour les femmes domicili\u00e9es dans l'un de ces trois d\u00e9partements.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es socio-d\u00e9mographiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"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\r\nConsommation de soins\/services de sant\u00e9\r\nQualit\u00e9 de vie\/sant\u00e9 per\u00e7ue"}]},"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 restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"2717 : several deficiency2414 : stillbirths2317 : medical termination of pregnancy"},"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":"","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":"15-12-2010","lastUpdatedAuto":null,"lastUpdatedManual":"02-04-2012","isContributorPI":"Non","contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"Liste des publications dans Pubmed","link":"http:\/\/tinyurl.com\/PUBMED-RHEOP"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)","Public (France)","Public (France)","Public (France)"],"otherFundingAgentType":["","","","",""]},"sponsor":{"sponsorType":["Public (France)","Public (France)","Public (France)","Public (France)"],"otherSponsorType":["","","",""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Non","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Un recueil syst\u00e9matique d'informations destin\u00e9es \u00e0 l'identification des cas est r\u00e9alis\u00e9 aupr\u00e8s:(1) des Maison D\u00e9partementale de l'Autonomie (MDA) et des maisons d\u00e9partementales des personnes handicap\u00e9es (MDPH) des d\u00e9partements concern\u00e9s(2) des services cliniques de n\u00e9onatalogie, p\u00e9diatrie, maternit\u00e9s et services sp\u00e9cialis\u00e9s \u00e0 partir des dossiers m\u00e9dicaux(3) des services d'information m\u00e9dicale(4) des Centres m\u00e9dicaux d'action pr\u00e9coce(5) des secteurs de p\u00e9dopsychiatrie(6) des PMI et des r\u00e9seaux de p\u00e9diatres lib\u00e9raux(7) des services de cytog\u00e9n\u00e9tique(8) des Centres pluridisciplinaires de diagnostics pr\u00e9natal (CPDNP)(9) des laboratoires d'anatomo-pathologie","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Is\u00e8re, Savoie, Haute Savoie"},"dataTypes":{"clinicalDataDetails":"","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"}