{"doc_desc":{"title":"Ile de la R\u00e9union Congenital anomalies register","idno":"FRESH-PEF231-en","producers":[{"name":"Hanitra RANDRIANAIVO","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE LA REUNION"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF231-en","IDno":{"metadata_no":[{"agency":"PEF","code":"231"},{"agency":"FReSH","code":"FRESH-PEF231"}]},"title":"Ile de la R\u00e9union Congenital anomalies register","alternate_title":""},"study_authorization":{"agency":[]},"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 id"},{"title":"","uri":"","role":"pi id"},{"title":"SIREN","uri":"200030013","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"benedicte.bertaut-nativel@chu-reunion.fr","isContact":"Yes"},{"type":"investigator","name":"Hanitra;RANDRIANAIVO","PILabo":"CHU Site de Sud \/ Unit\u00e9 de G\u00e9n\u00e9tique m\u00e9dicale du CHR Sud R\u00e9union","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE LA REUNION","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"181683156","role":"pi id"},{"title":"SIREN","uri":"200030013","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"hanitra.randrianaivo@chu-reunion.fr","isContact":"Yes"}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (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":"congenital abnormalities"},{"keyword":"prenatal diagnosis"},{"keyword":"alert"},{"keyword":"toxic risk factors to reproduction"},{"keyword":"teratogens"},{"keyword":"genetics"},{"keyword":"database"},{"keyword":"epidemiology"},{"keyword":"surveillance"}],"topics":[{"topic":"Certain infectious or parasitic diseases","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1435254666","title":"CIM-11"}]},{"topic":"Behavioral determinants: Addiction","vocab":"health determinant"},{"topic":"Socio-demographic and economic determinants","vocab":"health determinant"},{"topic":"Biological determinants: Genetic predisposition","vocab":"health determinant"},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Environmental determinants: Other","vocab":"health determinant"},{"topic":"Behavioral determinants: Eating habits","vocab":"health determinant"},{"topic":"Environmental determinants","vocab":"health determinant"},{"topic":"Socio-demographic and economic determinants: Employment","vocab":"health determinant"},{"topic":"Behavioral determinants","vocab":"health determinant"},{"topic":"Biological determinants","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"1. Carry out epidemiological surveillance of congenital abnormalities in the population of Reunion Island (determination of prevalence and distribution) and identification of malformation risk factors (genetic, environmental, related to drugs or toxins); with the purpose of sounding the alert when any environmental teratogenic agents become evident (e.g. drug, pesticide exposure, industrial accident) at local, national and international level. Should clusters of malformations be detected (surveillance-alert of an increase in prevalence over time of a given malformation), checks must be made regarding recording bias before conducting further investigations. Then specific risk factors will be sought. 2. Evaluate the impact of public health initiatives in the population: - Evaluation of prenatal screening of malformations is a fundamental objective for the registry, with participation in the field of perinatal medicine and local obstetric practices - Implementation and evaluation of prevention initiatives are also important, such as the primary prevention of neural tube closing defects via folic acid supplements before conception. 2. Identification of possible new syndromes and supply of new information for genetic counseling of families. e-transmission method, genetic heterogeneity, genetic susceptibility factor.","abstract":"","coll_dates":[{"start":"2002-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['La R\u00e9union']","analysis_unit":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\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\": \"Infant, Newborn (birth to 28 days)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007231\"\n            }\n        },\n        {\n            \"value\": \"Infant (28 days to 2 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007223\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"The Registry lists cases of malformation and chromosomal abnormality among living births, still births (from 22 weeks of amenorrhea or more), which are diagnosed within or at one year, as well as therapeutic abortions irrespective of the gestational age. The following are included in the registry:  Congenital malformations diagnosed before or after the birth - up until the end of the infant's first year of life.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Socio-demographic data']","quality_statement":{"standards":[{"name":"['ICD10 for malformations and diseases']","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth event\/mortality"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":""}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}"],"research_instrument":"Free access","sources":[{"sourceCitation":{"titlStmt":{"titl":""},"holdings":"","notes":{"subject":"source purpose","value":""}},"srcOrig":["Medico-administrative database"]}],"target_sample_size":"[1000-10000[ individuals","response_rate":"2002-2009: 3046 cas (source EUROCAT)2009 : 419 cas (source EUROCAT)"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Morbidity registry"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Access to individual (anonymized) data possible by request.","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"03-01-2011","lastUpdatedAuto":null,"lastUpdatedManual":"11-07-2018","isContributorPI":"No","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":"Yes"},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":"Yes"},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Active collection: survey takers go to the departments and record in their databases all of the information contained in the medical records concerning congenital malformations and their determining factors","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Yes"},"geographicalCoverage":{"geoDetail":"Reunion department"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[""]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}