{"doc_desc":{"title":"Cohorte de patients pr\u00e9sentant une maladie r\u00e9nale chronique, non dialys\u00e9s","idno":"FRESH-PEF73364-fr","producers":[{"name":"St\u00e9phanie GROJEAN","affiliation":"FONDATION FORCE POUR L'INNOVATION ET LA RECHERDHE EN SANTE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73364-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73364"},{"agency":"FReSH","code":"FRESH-PEF73364"}]},"title":"Cohorte de patients pr\u00e9sentant une maladie r\u00e9nale chronique, non dialys\u00e9s","alternate_title":"ND-CRIS : Non dialysis- Chronic renal insufficiency study"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"St\u00e9phanie;GROJEAN","PILabo":"Fondation FORCE \/ D\u00e9partement Recherche, Conseil et Formation","affiliationName":"FONDATION FORCE POUR L'INNOVATION ET LA RECHERDHE EN SANTE","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"070545790","role":"pi id"},{"title":"SIREN","uri":"351982707","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"ND-CRIS@fondation-force.fr","isContact":"Oui"}],"oth_id":[{"name":"prise en charge de patients insuffisants r\u00e9naux chroniques atteints d'une forme autosomique dominante de polykystose","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"FONDATION FORCE POUR L'INNOVATION ET LA RECHERDHE EN SANTE","extlink":[{"title":"SIREN","uri":"351982707","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"FONDATION FORCE POUR L'INNOVATION ET LA RECHERDHE EN SANTE","extlink":[{"title":"SIREN","uri":"351982707"}]}]},"distribution_statement":{"contact":[{"name":"St\u00e9phanie;GROJEAN","email":"ND-CRIS@fondation-force.fr","type":"contact","affiliationName":"FONDATION FORCE POUR L'INNOVATION ET LA RECHERDHE EN SANTE","contactPointLabo":"","extlink":[{"uri":"351982707","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Insuffisance r\u00e9nale chronique"},{"keyword":"maladie r\u00e9nale chronique"},{"keyword":"diab\u00e8te"},{"keyword":"hypertension art\u00e9rielle"},{"keyword":"m\u00e9dicaments"}],"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 li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux : Autres","vocab":"health determinant"},{"topic":"Autre","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux","vocab":"health determinant"}],"purpose":"L\u2019objectif principal est de d\u00e9crire la population des patients IRC-ND pris en charge par les n\u00e9phrologues et de suivre la pente de la baisse de la fonction r\u00e9nale au cours du temps. La cohorte ND-CRIS permettra parall\u00e8lement d\u2019apporter des donn\u00e9es r\u00e9guli\u00e8res sur la prise en charge th\u00e9rapeutique (prescription m\u00e9dicamenteuse notamment) et la prescription des examens biologiques des m\u00e9decins dans les centres. Les autres objectifs seront : \u2022 de d\u00e9crire l\u2019\u00e9volution des patients inclus jusqu\u2019\u00e0 leur \u00e9ventuel recours \u00e0 une technique de suppl\u00e9ance avec une description sp\u00e9cifique des caract\u00e9ristiques des patients au moment de l'arriv\u00e9e au stade terminal \u2022 de d\u00e9terminer les facteurs de risque de cette \u00e9volution., \u2022 de d\u00e9crire l\u2019\u00e9volution des caract\u00e9ristiques de la population prise en charge ce qui permettra de conna\u00eetre l\u2019\u00e9volution \u00e9pid\u00e9miologique des patients atteints d\u2019IRC-ND dans la r\u00e9gion Bourgogne-Franche-Comt\u00e9 \u2022 de r\u00e9aliser des \u00e9tudes ad hoc pour \u00e9valuer le rapport b\u00e9n\u00e9fice-risque des produits et actions de sant\u00e9. In fine, la cohorte ND-CRIS devrait constituer un outil \u00e9pid\u00e9miologique p\u00e9renne dans le domaine de l\u2019IRC-ND.","abstract":"","coll_dates":[{"start":"2012-01-01"}],"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\": \"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\": \"La population \u00e9ligible est celle des patients pr\u00e9sentant un CKD avec deux mesures du GRF<60 ml\\\/min\\\/1,73m2 calcul\u00e9 avec la m\u00e9thode du MDRD. La population source est celle des patients adultes (>18 ans) trait\u00e9s par les \u00e9quipes de n\u00e9phrologie des centres participants. \",\n \"clusion_E\": \"les patients greff\u00e9s, dialys\u00e9s, les patients de passage non suivis dans les centres participants et les patients incapables de comprendre la note d\u2019information\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es paracliniques','Donn\u00e9es biologiques','Donn\u00e9es socio-d\u00e9mographiques','Donn\u00e9es paracliniques (hors biologiques) : Imagerie']","quality_statement":{"standards":[{"name":"['Codage ATC des m\u00e9dicaments et WHODRUG pour les maladies']","committee":"","governance":""}],"other_quality_statement":"['Monitoring \u00e0 distance via l\\'eCRF et Monitoring sur sites']"}},"study_development":{"development_activity":[]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Probability.Stratified\",\"vocab\":\"CESSDA\"},\"value\":\"Probabiliste : stratifi\u00e9\"}']","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":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"2019 : 5462 patients"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Cohorte"]}]},"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":"Convention de mise \u00e0 disposition D\u00e9lais de mise \u00e0 disposition variable en fonction du type de projet. En moyenne, 1 semaine.","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":"Base de donn\u00e9es csv;xlsx."}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"----","lastUpdatedAuto":null,"lastUpdatedManual":"17-02-2020","isContributorPI":"Non","contributorName":"St\u00e9phanie GROJEAN","contributorAffiliation":"FONDATION FORCE POUR L'INNOVATION ET LA RECHERDHE EN SANTE","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Priv\u00e9 \u00e0 but non lucratif"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Priv\u00e9 \u00e0 but non lucratif"],"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":"Recueil hebdomadaire sur CRF \u00e9lectronique des donn\u00e9es par technicienne de recherche sur la base des dossiers m\u00e9dicaux","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Centres hospitaliers de Bourgogne-Franche-Comt\u00e9 :Besan\u00e7on, M\u00e2con, Montb\u00e9liard, Vesoul, Auxerre, D\u00f4le, Sens, Dijon, Chalon-sur-sa\u00f4ne"},"dataTypes":{"clinicalDataDetails":"Poids, taille, diagnostic de la maladie, comorbidit\u00e9s, traitements m\u00e9dicamenteux","biologicalDataDetails":"Cr\u00e9atinin\u00e9mie, prot\u00e9inurie, calc\u00e9mie, phosphor\u00e9mie, HbA1c, h\u00e9moglobine, vitamine D3, PTH, fer, ferritine, ur\u00e9e urinaire, uric\u00e9mie","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}