{"doc_desc":{"title":"Registre \u00e9pid\u00e9miologique de l'atr\u00e9sie de l'oesophage (registre qualifi\u00e9)","idno":"FRESH-PEF180-fr","producers":[{"name":"Rony SFEIR","affiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF180-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"180"},{"agency":"FReSH","code":"FRESH-PEF180"}]},"title":"Registre \u00e9pid\u00e9miologique de l'atr\u00e9sie de l'oesophage (registre qualifi\u00e9)","alternate_title":""},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Rony;SFEIR","PILabo":"CHRU \/ Reference center for congenital esophageal abnormalities","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ORCID","uri":"0000-0001-9755-0954","role":"pi id"},{"title":"IdRef","uri":"15339904X","role":"pi id"},{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"rony.sfeir@chru-lille.fr","isContact":"Oui"}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE (CHU)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02ppyfa04","role":"sponsor id"},{"title":"SIREN","uri":"265906719","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":""}]},"distribution_statement":{"contact":[{"name":"Rony;SFEIR","email":"rony.sfeir@chru-lille.fr","type":"contact","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id","title":"ROR"},{"uri":"267500452","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"atr\u00e9sie"},{"keyword":"\u00e9pid\u00e9miologie"}],"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":"Pneumologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/f6e18c52-6087-4662-904c-5c4b8174e40e"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D015272"}]},{"topic":"Gastroent\u00e9rologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/a3898340-a42d-4f5e-a822-1de204a9a867"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D005762"}]},{"topic":"Atr\u00e9sie de l'\u0153sophage","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1582061097","title":"CIM-11"}]},{"topic":"D\u00e9terminants biologiques : Pr\u00e9dispositions g\u00e9n\u00e9tiques","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux : Autres","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux : Alimentation","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux","vocab":"health determinant"}],"purpose":"Objectifs du registre dans le domaine de la sant\u00e9 publique (acc\u00e8s au diagnostic ante et postnatal, surveillance, prise en charge des patients, \u00e9valuation) : 1) D\u00e9terminer la pr\u00e9valence de l\u2019atr\u00e9sie de l\u2019\u0153sophage et de ses diff\u00e9rentes formes anatomiques. 2) \u00c9tudier la distribution g\u00e9ographique de cette malformation 3) D\u00e9terminer la mortalit\u00e9 \u00e0 un an de cette malformation 4) \u00c9valuer les disparit\u00e9s de prise en charge et d\u2019\u00e9volution entre les diff\u00e9rents centres. Objectifs du registre dans les domaines de la th\u00e9rapeutique et de la recherche: 1) \u00c9valuer si le pourcentage de diagnostic ant\u00e9natal et la pr\u00e9cocit\u00e9 de prise en charge varient dans notre pays dans les prochaines ann\u00e9es. 2) \u00c9valuer l\u2019effet du diagnostic ant\u00e9natal sur la pr\u00e9valence. 3) \u00c9valuer les modifications survenues dans la prise en charge des nouveaux n\u00e9s pr\u00e9sentant une atr\u00e9sie de l\u2019\u0153sophage et l\u2019influence de celle-ci sur le devenir des patients. Des modifications r\u00e9centes de la prise en charge : pose de sonde transanatomique, r\u00e9alimentation pr\u00e9coce, abandon de la nutrition parent\u00e9rale, pourraient influencer l\u2019\u00e9volution (dur\u00e9e d\u2019hospitalisation, complications) et le devenir \u00e0 1 an. 4) \u00c9valuer le pronostic \u00e0 court terme (complications chirurgicales, dur\u00e9e d\u2019hospitalisation, dur\u00e9e de r\u00e9animation\u2026). 5) Structurer et harmoniser les prises en charge de l\u2019atr\u00e9sie de l\u2019\u0153sophage au sein du territoire national.","abstract":"","coll_dates":[{"start":"2008-01-01","end":"2020-01-01"}],"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                \"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\": \"Tout nouveau n\u00e9 vivant porteur d'une atr\u00e9sie de l'oesophage\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es paracliniques','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"}]},"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\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"2000"},"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":"16-12-2010","lastUpdatedAuto":null,"lastUpdatedManual":"21-09-2020","isContributorPI":"Non","contributorName":"Rony SFEIR","contributorAffiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":[],"otherFundingAgentType":[]},"sponsor":{"sponsorType":["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":"- Demande t\u00e9l\u00e9phonique r\u00e9guli\u00e8re, relance par courriel et courrier et d\u00e9placements sur place dans les 38 centres constituant le R\u00e9seau Epid\u00e9miologie et de recherche sur l\u2019atr\u00e9sie de l\u2019\u0153sophage.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"France m\u00e9tropolitaine + DOM TOM"},"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"}