{"doc_desc":{"title":"REGISTRE DES HEPATITES DE COTE-D\u2019OR ET DOUBS (registre qualifi\u00e9 2012-2015)","idno":"FRESH-PEF220-fr","producers":[{"name":"Anne MINELLO","affiliation":"chu"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF220-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"220"},{"agency":"FReSH","code":"FRESH-PEF220"}]},"title":"REGISTRE DES HEPATITES DE COTE-D\u2019OR ET DOUBS (registre qualifi\u00e9 2012-2015)","alternate_title":""},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Anne;MINELLO","PILabo":"CHU \/ Inserm U 866. Facult\u00e9 de M\u00e9decine de Dijon","affiliationName":"chu","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"079360971","role":"pi id"},{"title":"SIREN","uri":"262100076","role":"organisation id"},{"title":"RNSR","uri":"200716508T","role":"labo id"}],"email":"anne.minello@chu-dijon.fr","isContact":"Oui"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE DIJON","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/0377z4z10","role":"sponsor id"},{"title":"SIREN","uri":"262100076","role":"sponsor id"}],"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"}]}]},"distribution_statement":{"contact":[{"name":"Anne;MINELLO","email":"anne.minello@chu-dijon.fr","type":"contact","affiliationName":"chu","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/0377z4z10","role":"organisation id","title":"ROR"},{"uri":"262100076","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"virus C virus B incidence"}],"topics":[{"topic":"Infectiologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/fa2ceeab-3b2f-45e9-9243-e5a8005b98de"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D055552"}]},{"topic":"H\u00e9patologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/27c456a1-051a-42f6-b52a-3beff0487da7"}]},{"topic":"Certaines maladies inflammatoires pr\u00e9cis\u00e9es du foie","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/2046015098","title":"CIM-11"}]},{"topic":"Cirrhose h\u00e9patique","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1781315693","title":"CIM-11"}]},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"}],"purpose":"Objectifs du registre en termes sant\u00e9 publique (surveillance, \u00e9valuation) Ils se d\u00e9veloppent selon deux axes : l\u2019\u00e9pid\u00e9miologie descriptive et l\u2019\u00e9valuation des pratiques de soins. Le premier axe a pour objectif la surveillance sanitaire des infections virales B et C : - \u00e9tude des taux de d\u00e9tection des s\u00e9rologies virales B et C et de leur \u00e9volution, - \u00e9tude de l\u2019\u00e9volution au cours du temps des modes de contamination, - \u00e9tude des modalit\u00e9s diagnostiques (d\u00e9pistage syst\u00e9matique, d\u00e9marche diagnostique devant des anomalies biologiques ou des sympt\u00f4mes), - \u00e9valuation de l\u2019impact sur l\u2019incidence des h\u00e9patites aigu\u00ebs B du changement de politique vaccinale anti-virale B en 1998. Dans le domaine des pratiques de soins nos objectifs sont : - \u00e9tude des modalit\u00e9s de prise en charge des h\u00e9patites virale B et C au niveau de la population prise dans son ensemble, - \u00e9valuation de l\u2019impact des conf\u00e9rences de consensus et des recommandations nationales de bonnes pratiques cliniques, - analyse des fili\u00e8res de soins. Objectifs du registre en termes de recherche - Etude de l\u2019histoire naturelle des h\u00e9patites B et C dans la cohorte constitu\u00e9e : causes de mortalit\u00e9, risque de complications. - Etudes anthropologiques pour comprendre les freins \u00e0 la prise en charge des patients atteints d\u2019h\u00e9patite C et \u00e9tude des d\u00e9terminants de la proposition de diagnostic et de soins des migrants atteints d\u2019h\u00e9patite B et C. - Relation entre les caract\u00e9ristiques \u00e9pid\u00e9miologiques des h\u00e9patites virales B et C, leur prise en charge et les facteurs d\u2019environnement (habitat, cat\u00e9gories sociales\u2026). - Etude du risque de lymphome non hodgkinien chez les malades contamin\u00e9s par le virus C.","abstract":"","coll_dates":[{"start":"1994-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Bourgogne Franche-Comt\u00e9']","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\": \"Petite enfance (2 \u00e0 5 ans)\",\n            \"concept\": {\n                \"vocab\": \"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            \"value\": \"Adulte (19 \u00e0 24 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adulte (25 \u00e0 44 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Adulte (45 \u00e0 64 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Grand \u00e2ge (80 ans et plus)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Adultes et Enfants porteurs de l\u2019antig\u00e8ne HBs (Ag HBs) et\\\/ou des anticorps anti-virus de l\u2019h\u00e9patite C (VHC)\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es biologiques','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\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"1994-2009: 3750"},"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 du Registre 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":"28-12-2010","lastUpdatedAuto":null,"lastUpdatedManual":"15-09-2017","isContributorPI":"Non","contributorName":"Anne MINELLO","contributorAffiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE DIJON","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/tinyurl.com\/PUBMED-RHCD"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Oui","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Recueil actif (Envois en temps r\u00e9el par les laboratoires et signalement en temps r\u00e9el par les gastroent\u00e9rologues)","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"C\u00f4te-d'or et Doubs"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"ADN, ARN, TransaminasesS\u00e9rologies virales D, HIV","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}