{"study_desc":{"title_statement":{"idno":"FRESH-PEF60-en","IDno":{"metadata_no":[{"agency":"PEF","code":"60"},{"agency":"FReSH","code":"FRESH-PEF60"}]},"title":"FranceCoag Network","alternate_title":"FCN"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"V\u00e9ronique;GOULET","firstname":"V\u00e9ronique","lastname":"GOULET","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00dfw9p58","role":"organisation id"},{"title":"SIREN","uri":"130022338","role":"organisation id"},{"uri":"066907454","role":"pi id","title":"IdRef"}],"email":"","affiliationName":"SANTE PUBLIQUE FRANCE","PILabo":"INVS - Institut de Veille \/ D\u00e9partement des maladies chroniques et traumatismes","isContact":false}],"oth_id":[{"name":"Participation in the World Federation of hemophilia (WFH)","type":"collaboration"}],"production_statement":{"prod_place":"Epidemiology France Portal (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":"haemophilia"},{"keyword":"von Willebrand disease"},{"keyword":"national registry"},{"keyword":"inhibitor"},{"keyword":"hereditary hemorrhagic diseases"},{"keyword":"replacement therapy"},{"keyword":"prophylaxis"}],"topics":[{"topic":"Hematology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/9239f328-78c9-40a5-a0b9-8e66fd9b6245"},{"title":"MeSH","uri":"D006402"}]},{"topic":"Chronic hepatitis C","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1615937473","title":"CIM-11"}]},{"topic":"Chronic hepatitis B","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/352087872","title":"CIM-11"}]},{"topic":"Human immunodeficiency virus disease without mention of tuberculosis or malaria","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1508081745","title":"CIM-11"}]},{"topic":"Von Willebrand disease","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/2112021600","title":"CIM-11"}]},{"topic":"Environmental determinants: Other","vocab":"health determinant"},{"topic":"Biological determinants: Genetic predisposition","vocab":"health determinant"},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Environmental determinants","vocab":"health determinant"},{"topic":"Biological determinants","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"Four objectives: 1) Thorough knowledge of the epidemiological characteristics of hereditary haemorrhagic diseases ; 2) To monitor the health of this population; 3) To know the risk factors of inhibitor's development (treatment side effect) and their therapeutic managment; 4) To assess the impact of preventive treatment and contribute to improving the quality of healthcare.","abstract":"","coll_dates":[{"start":"1994-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individuals","universe":"{\"level_sex_clusion_I\":[{\"value\":\"Male\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D008297\"}},{\"value\":\"Female\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D005260\"}}],\"level_age_clusion_I\":[{\"value\":\"Infant, Newborn (birth to 28 days)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D007231\"}},{\"value\":\"Infant (28 days to 2 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D007223\"}},{\"value\":\"Child, Preschool (2 to 5 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D002675\"}},{\"value\":\"Child (6 to 12 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D002648\"}},{\"value\":\"Adolescent (13 to 18 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000293\"}},{\"value\":\"Young Adult (19 to 24 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D055815\"}},{\"value\":\"Adult (25 to 44 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000328\"}},{\"value\":\"Middle Aged (45 to 64 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D008875\"}},{\"value\":\"Aged (65 to 79 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000368\"}},{\"value\":\"Aged, 80 and over (80 years and more)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000369\"}}],\"level_type_clusion_I\":\"Patients population\",\"level_type_clusion_other\":\"\",\"clusion_I\":\"Patients with: - Hemophilia A or B with factor VIII (FVIII) or factor (FIX) <40%; - Type 1 von Willebrand disease (VWD) with VWF:Ag <30%; Type 2 with a VWF:RCo\/VWF:Ag ratio <0.7 or VWF:CB\/VWF:Ag <0.7 or FVIII:C\/VWF:Ag < 0.5 or positive RIPA; Type 3 with VWF:Ag and VWF:RCo <5%; - Afibrinogenemia (fibrinogen < 0.2 g \/ l); - a deficiency in factor FII, FV, FVII, FX, FXIII <10%, FXI <20% or FV + FVIII <30%.\",\"clusion_E\":\"\"}","data_kind":"['Clinical data','Paraclinical data (non-biological)','Paraclinical data (non-biological) : Function testing','Biological data']","quality_statement":{"standards":[{"name":"['Coding conventions specific to project.']","committee":"","governance":""}],"other_quality_statement":"['Data monitoring conducted by 3 clinical research associates. Data are checked: - at the coordination centre by automatically processing collected data after recording (missing data, outliers and inconsistent data) - in treatment centres against clinical files on 100% of forms: General cohort (on a selection of items); PUPS sub-cohort (all data).']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth event\/mortality\r\nHealth care consumption and services\r\nOthers"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}"],"research_instrument":"","sources":[],"target_sample_size":"[1000-10000[ individuals","response_rate":"9,288 patients enrolled on 07\/09\/2015."},"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\"}]}","notes":""},"dataset_use":{"restrictions":"","conditions":"Access to operation results on the database through webFC, dedicated RFC computer application (http:\/\/www.francecoag.org). Database is accessible to all internal or external researchers interested in the project after submitting a project to 2 experts that is validated by members of the RFC Steering Committee.","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""}}},"additional":{"versionLang":"en","originLang":"en","autoTranslation":false,"status":"Imported","creationDate":"10-12-2010","lastUpdatedManual":"13-05-2015","isContributorPI":"","contributorName":"","contributorAffiliation":"","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":true},"theme":{"complementaryInformation":"","RareDiseases":true},"activeFollowUp":{"isActiveFollowUp":true,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Data are gathered through electronic forms by clinicians following patients in 36 haemophilia treatment centres throughout the national territory.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"Patients are included throughout the national territory and monitored by 36 haemophilia treatment centres (HTC)."},"dataTypes":{"clinicalDataDetails":"History, Ongoing Treatment, Diagnostics, Extension Review, Treatments Received (cycle to cycle), treatment discontinuation, Evaluations, Progression, Second Cancer, Death","biologicalDataDetails":"Deficient factor base rate, inhibitor research assessment, etc.","isDataInBiobank":true,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}