{"doc_desc":{"title":"Registre du R\u00e9seau Epid\u00e9miologie et Information en N\u00e9phrologie","idno":"FRESH-PEF5623-fr","producers":[{"name":"Christian JACQUELINET","affiliation":"AGENCE DE LA BIOMEDECINE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF5623-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"5623"},{"agency":"FReSH","code":"FRESH-PEF5623"}]},"title":"Registre du R\u00e9seau Epid\u00e9miologie et Information en N\u00e9phrologie","alternate_title":"REIN"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Christian;JACQUELINET","PILabo":"Agence de la biomedecine \/ Direction M\u00e9dicale et Scientifique","affiliationName":"AGENCE DE LA BIOMEDECINE","extlink":[{"title":"ORCID","uri":"0000-0002-5904-7570","role":"pi id"},{"title":"IdRef","uri":"074539973","role":"pi id"},{"title":"SIREN","uri":"180092587","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"christian.jacquelinet@biomedecine.fr","isContact":"Oui"}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"AGENCE DE LA BIOMEDECINE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03tajza86","role":"sponsor id"},{"title":"SIREN","uri":"180092587","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":""}]},"distribution_statement":{"contact":[{"name":"C\u00e9cile;COUCHOUD","email":"cecile.couchoud@biomedecine.fr","type":"contact","affiliationName":"AGENCE DE LA BIOMEDECINE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/03tajza86","role":"organisation id","title":"ROR"},{"uri":"180092587","role":"organisation id","title":"SIREN"}]},{"name":"Christian;JACQUELINET","email":"christian.jacquelinet@biomedecine.fr","type":"contact","affiliationName":"AGENCE DE LA BIOMEDECINE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/03tajza86","role":"organisation id","title":"ROR"},{"uri":"180092587","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"donn\u00e9es"},{"keyword":"interpr\u00e9tation"},{"keyword":"d\u00e9cision"},{"keyword":"expertise \u00e9pid\u00e9miologique"},{"keyword":"bio-statistique"},{"keyword":"patients dialys\u00e9s ou transplant\u00e9s"},{"keyword":"taux de mortalit\u00e9 et l\u2019\u00e9volution"},{"keyword":"handicaps associ\u00e9s"},{"keyword":"incidence"},{"keyword":"pr\u00e9valence"},{"keyword":"caract\u00e9ristiques sociod\u00e9mographiques"},{"keyword":"co-morbidit\u00e9s"},{"keyword":"prise en charge"}],"topics":[{"topic":"N\u00e9phrologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/3961e9d2-ab3b-451b-b246-20fc0ec3b0c4"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D009398"}]},{"topic":"Insuffisance r\u00e9nale","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/761526554","title":"CIM-11"}]},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"},{"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":"Syst\u00e8mes de soins et acc\u00e8s aux soins","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux","vocab":"health determinant"}],"purpose":"Mettre en place un syst\u00e8me d\u2019information p\u00e9renne, regroupant autour des donn\u00e9es, de leur interpr\u00e9tation et de leur utilisation potentielle pour la d\u00e9cision en sant\u00e9 publique ou la pratique clinique l'ensemble des partenaires concern\u00e9s (organisation en r\u00e9seau) et disposant de l\u2019expertise \u00e9pid\u00e9miologique, bio-statistique et informatique n\u00e9cessaire pour : - D\u00e9nombrer l\u2019ensemble des patients dialys\u00e9s ou transplant\u00e9s pour insuffisance r\u00e9nale chronique en France m\u00e9tropolitaine et dans les DOM-TOM, - Evaluer l\u2019incidence (objectif 80 de la loi de Sant\u00e9 Publique), la pr\u00e9valence, les taux de mortalit\u00e9 et l\u2019\u00e9volution au cours du temps de l\u2019insuffisance r\u00e9nale chronique trait\u00e9e selon la r\u00e9gion, les caract\u00e9ristiques sociod\u00e9mographiques des malades, la maladie r\u00e9nale initiale, les co-morbidit\u00e9s et les handicaps associ\u00e9s, - D\u00e9crire pr\u00e9cis\u00e9ment les modalit\u00e9s de prise en charge en dialyse (m\u00e9thode, modalit\u00e9, dose) et les tendances \u00e9volutives des besoins de la population et des pratiques m\u00e9dicales, - Mesurer les parts relatives prises par les diff\u00e9rentes modalit\u00e9s de dialyse et par la greffe et d\u00e9crire les trajectoires des patients \u00e0 travers ces modalit\u00e9s de prise en charge, - Evaluer la qualit\u00e9 et l\u2019efficacit\u00e9 des soins en termes de pr\u00e9cocit\u00e9 de la prise en charge, de dose de dialyse, de contr\u00f4le de l\u2019an\u00e9mie et de l\u2019\u00e9quilibre nutritionnel, au regard notamment des recommandations de bonnes pratiques cliniques, - Evaluer la qualit\u00e9 de vie des patients (objectif 81 de la loi de Sant\u00e9 Publique); - Evaluer les cons\u00e9quences m\u00e9dico-\u00e9conomiques des pratiques de soins.","abstract":"","coll_dates":[{"start":"2003-01-01"}],"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\": \"Mise en route d'un traitement (dialyse ou greffe) pour Insuffisance R\u00e9nale Chronique Terminale (IRCT)\",\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\":\"Recording\",\"vocab\":\"CESSDA\"},\"value\":\"Enregistrement (audio, vid\u00e9o, \u00e9lectrophysiologique, imagerie)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":">= 20000 individus","response_rate":"Au 31\/12\/2012 : 90685- 10048 nouveaux cas- 73491 patients trait\u00e9s- 7146 d\u00e9c\u00e8s"},"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":"Contacter le responsable scientifique","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":"08-03-2013","lastUpdatedAuto":null,"lastUpdatedManual":"06-09-2017","isContributorPI":"Non","contributorName":"Christian JACQUELINET","contributorAffiliation":"AGENCE DE LA BIOMEDECINE","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.soc-nephrologie.org\/PDF\/enephro\/registres\/rapport_2012\/rapport_2012.pdf"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":[],"otherFundingAgentType":[]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":"Oui"},"collaborations":{"networkConsortium":"Oui"},"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":"L\u2019identification d\u2019une structure d\u2019appui \u00e9pid\u00e9miologique et le recrutement d\u2019attach\u00e9s de recherche clinique sont les conditions impos\u00e9es par REIN \u00e0 toute r\u00e9gion int\u00e9grant le r\u00e9seau.Le travail des attach\u00e9s de recherche clinique comporte trois parties :- un contr\u00f4le continu de l\u2019exhaustivit\u00e9 de l\u2019enregistrement des nouveaux patients, des \u00e9v\u00e8nements et dessuivis annuels, qui doit \u00eatre assur\u00e9 tout au long de l\u2019ann\u00e9e. Parfois, l\u2019attach\u00e9 de recherche clinique peutparticiper, de fa\u00e7on transitoire, \u00e0 la saisie des donn\u00e9es dans le syst\u00e8me d\u2019information \u00e0 partir de fichesremplies par les m\u00e9decins.- un contr\u00f4le annuel de la qualit\u00e9 des informations, r\u00e9alis\u00e9 chaque premier trimestre, sur l\u2019ensemble despatients mais pour un nombre limit\u00e9 de donn\u00e9es dites essentielles recueillies l\u2019ann\u00e9e pr\u00e9c\u00e9dente, avant envoi \u00e0 la coordination nationale.- des contr\u00f4les ad hoc portant sur des \u00e9chantillons de patients pour les autres donn\u00e9es.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"France M\u00e9tropolitaine, DOM et POM"},"dataTypes":{"clinicalDataDetails":"--","biologicalDataDetails":"Activit\u00e9 17%Cr\u00e9atinim\u00e9mieH\u00e9moglobin\u00e9mieAlbumin\u00e9mieD\u00e9bit de filtration glom\u00e9rulaireCr\u00e9atinim\u00e9mie 19%CNR \u2013 Dossier de qualification 2008 14\/65H\u00e9moglobin\u00e9mieAlbumin\u00e9mieErythropoi\u00e9tine","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}