{"doc_desc":{"title":"R\u00e9seau FranceCoag","idno":"FRESH-PEF60-fr","producers":[{"name":"Vanessa MILIEN","affiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE (AP-HM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60"},{"agency":"FReSH","code":"FRESH-PEF60"}]},"title":"R\u00e9seau FranceCoag","alternate_title":"RFC"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"V\u00e9ronique;GOULET","PILabo":"INVS - Institut de Veille \/ D\u00e9partement des maladies chroniques et traumatismes","affiliationName":"SANTE PUBLIQUE FRANCE","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"066907454","role":"pi id"},{"title":"SIREN","uri":"130022338","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"","isContact":"Non"}],"oth_id":[{"name":"Participation \u00e0 la F\u00e9d\u00e9ration Mondiale de l\u2019H\u00e9mophilie","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"SANTE PUBLIQUE FRANCE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00dfw9p58","role":"sponsor id"},{"title":"SIREN","uri":"130022338","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01wp0c315"},{"title":"SIREN","uri":"130016546"}]}]},"distribution_statement":{"contact":[{"name":"","type":"contact"}]},"study_info":{"keywords":[{"keyword":"DHPC"},{"keyword":"H\u00e9mophilie"},{"keyword":"Maladie de Willebrand"},{"keyword":"Registre national"},{"keyword":"Traitement substitutif"},{"keyword":"Traitement prophylactique"},{"keyword":"Inhibiteur"}],"topics":[{"topic":"H\u00e9matologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/9239f328-78c9-40a5-a0b9-8e66fd9b6245"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D006402"}]},{"topic":"H\u00e9patite C chronique","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1615937473","title":"CIM-11"}]},{"topic":"H\u00e9patite B chronique","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/352087872","title":"CIM-11"}]},{"topic":"Maladie par le virus de l'immunod\u00e9ficience humaine sans mention de tuberculose ni de paludisme","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1508081745","title":"CIM-11"}]},{"topic":"Maladie de von Willebrand","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/2112021600","title":"CIM-11"}]},{"topic":"D\u00e9terminants environnementaux : Autres","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","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":"Quatre objectifs : 1) conna\u00eetre de fa\u00e7on exhaustive les caract\u00e9ristiques \u00e9pid\u00e9miologiques des maladies h\u00e9morragiques dues \u00e0 des d\u00e9ficits h\u00e9r\u00e9ditaires s\u00e9v\u00e8res en prot\u00e9ines coagulantes (DHPC) 2) r\u00e9aliser une surveillance sanitaire de cette population 3) conna\u00eetre les facteurs de risque de l\u2019apparition des inhibiteurs (effet secondaire d\u00fb au traitement) et les modalit\u00e9s de leur prise en charge 4) \u00e9valuer l\u2019impact des traitements prophylactiques et contribuer \u00e0 l\u2019am\u00e9lioration de la qualit\u00e9 des soins","abstract":"","coll_dates":[{"start":"1994-01-01"}],"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            \"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\": \"Les patients atteints :  - d\u2019une h\u00e9mophilie A ou B avec un taux de facteur VIII (FVIII) ou facteur (FIX) inf\u00e9rieur \u00e0 40% ; - d\u2019une maladie de Willebrand (MW) de type 1 avec VWF:Ag inf\u00e9rieur \u00e0 30% ; de type 2 avec un rapport VWF:RCo\\\/VWF:Ag inf\u00e9rieur \u00e0 0,7 ou VWF:CB\\\/VWF:Ag inf\u00e9rieur \u00e0 0,7 ou FVIII:C\\\/VWF:Ag inf\u00e9rieur \u00e0 0,5 ou RIPA positive ; de type 3 avec VWF :Ag et VWF :RCo inf\u00e9rieur \u00e0 5%; - d\u2019une afibrinog\u00e9n\u00e9mie (fibrinog\u00e8ne  inf\u00e9rieur \u00e0 0,2 g\\\/l) ; -d\u2019un d\u00e9ficit en facteur FII, FV, FVII, FX, FXIII inf\u00e9rieur \u00e0 10%, en FXI inf\u00e9rieur \u00e0 20 % ou en FV+FVIII inf\u00e9rieur \u00e0 30 %.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es paracliniques','Donn\u00e9es biologiques','Donn\u00e9es paracliniques (hors biologiques) : Exploration fonctionnelle']","quality_statement":{"standards":[{"name":"['R\u00e8gles de codage propres au projet.']","committee":"","governance":""}],"other_quality_statement":"['Monitoring des donn\u00e9es effectu\u00e9es par 3 attach\u00e9s de recherche clinique. Les donn\u00e9es sont v\u00e9rifi\u00e9es : - au Centre coordinateur par contr\u00f4le automatis\u00e9 des donn\u00e9es collect\u00e9es \u00e0 la fin de la saisie (donn\u00e9es manquantes, aberrantes, incoh\u00e9rentes)- dans les centres de traitement par confrontation avec les dossiers m\u00e9dicaux \/ 100% des formulaires : Cohorte g\u00e9n\u00e9rale : sur une s\u00e9lection d\u2019items ; Sous cohorte-Pups : toutes les donn\u00e9es.']"}},"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\nAutres"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}"],"research_instrument":"","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"9288 patients inclus au 07\/09\/2015"},"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 r\u00e9sultats de l\u2019exploitation de la base via webFC, l\u2019application informatique d\u00e9di\u00e9e au RFC (http:\/\/www.francecoag.org). Base de donn\u00e9es accessibles \u00e0 tous chercheurs int\u00e9ress\u00e9s ext\u00e9rieurs ou int\u00e9rieurs au projet apr\u00e8s soumission d\u2019un projet qui devra \u00eatre soumis \u00e0 2 experts et \u00eatre valid\u00e9s par les membres du Comit\u00e9 d\u2019Orientation (CO) du RFC.","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":"10-12-2010","lastUpdatedAuto":null,"lastUpdatedManual":"13-05-2015","isContributorPI":"Non","contributorName":"Vanessa MILIEN","contributorAffiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE (AP-HM)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.francecoag.org\/SiteWebPublic\/html\/documentsTele.html"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"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":"Les donn\u00e9es sont recueillies via des formulaires \u00e9lectroniques par les cliniciens qui suivent les patients dans les 36 centres de traitement de l\u2019h\u00e9mophilie r\u00e9partis sur tout le territoire national.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Les patients inclus sont r\u00e9partis sur tout le territoire national et suivis par les 36 centres de traitement de l\u2019h\u00e9mophilie (CTH)."},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"taux de base de facteur d\u00e9ficitaire, bilan de recherche des inhibiteurs, etc.","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}