{"study_desc":{"title_statement":{"idno":"FRESH-PEF73364-en","IDno":{"metadata_no":[{"agency":"PEF","code":"73364"},{"agency":"FReSH","code":"FRESH-PEF73364"}]},"title":"Cohort of non-dialyzed patients with chronic kidney disease","alternate_title":"ND-CRIS : Non dialysis- Chronic renal insufficiency study"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"St\u00e9phanie;GROJEAN","firstname":"St\u00e9phanie","lastname":"GROJEAN","type":"investigator","extlink":[{"title":"SIREN","uri":"351982707","role":"organisation id"},{"uri":"070545790","role":"pi id","title":"IdRef"}],"email":"ND-CRIS@fondation-force.fr","affiliationName":"FONDATION FORCE POUR L'INNOVATION ET LA RECHERDHE EN SANTE","PILabo":"Fondation FORCE \/ D\u00e9partement Recherche, Conseil et Formation","isContact":true}],"oth_id":[{"name":"management of patients with chronic kidney failure due to autosomal dominant polycystic kidney disease","type":"collaboration"}],"production_statement":{"prod_place":"Epidemiology France Portal (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","lastname":"GROJEAN","firstname":"St\u00e9phanie","type":"contact","email":"ND-CRIS@fondation-force.fr","affiliationName":"FONDATION FORCE POUR L'INNOVATION ET LA RECHERDHE EN SANTE","contactPointLabo":"","extlink":[{"uri":"351982707","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Chronic renal failure"},{"keyword":"chronic kidney disease"},{"keyword":"diabetes"},{"keyword":"high blood pressure"},{"keyword":"medications"}],"topics":[{"topic":"Nephrology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/3961e9d2-ab3b-451b-b246-20fc0ec3b0c4"},{"title":"MeSH","uri":"D009398"}]},{"topic":"Kidney failure","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/761526554","title":"CIM-11"}]},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Environmental determinants: Other","vocab":"health determinant"},{"topic":"Other","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"},{"topic":"Environmental determinants","vocab":"health determinant"}],"purpose":"The main objective is to describe the population of CKD-ND patients managed by nephrologists and to follow the slope of the decline in renal function over time... At the same time, the ND-CRIS cohort will provide regular data on therapeutic management (particularly drug prescription) and the prescription of biological tests by physicians in the centers Other objectives include: - to describe the evolution of the patients included in the study until their eventual recourse to a suppletive technique, with a specific description of the characteristics of the patients at the time of their arrival at the terminal stage - determine the risk factors for this progression - describe the evolution of the characteristics of the population under care, which will provide information on the epidemiological evolution of patients with end-stage renal disease in the Bourgogne-Franche-Comt\u00e9 region - to carry out ad hoc studies to assess the benefit-risk ratio of healthcare products and actions Ultimately, the ND-CRIS cohort should become a permanent epidemiological tool in the field of CKD-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":"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\":\"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\":\"\",\"clusion_E\":\"\"}","data_kind":"['Clinical data','Paraclinical data (non-biological)','Paraclinical data (non-biological) : Imaging','Biological data','Socio-demographic data']","quality_statement":{"standards":[{"name":"['ATC Coding of Drugs and WHODRUG for Disease']","committee":"","governance":""}],"other_quality_statement":"['Remote monitoring via eCRF and on-site monitoring']"}},"study_development":{"development_activity":[]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Probability.Stratified\",\"vocab\":\"CESSDA\"},\"value\":\"Probability: Stratified\"}']","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":"","response_rate":"2019 : 5462 patients"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Cohort study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}","notes":"Database csv;xlsx."},"dataset_use":{"restrictions":"","conditions":"Availability agreement Availability times vary according to the type of project. On average, 1 week.","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""}}},"additional":{"versionLang":"en","originLang":"en","autoTranslation":false,"status":"Imported","creationDate":"----","lastUpdatedManual":"17-02-2020","isContributorPI":"","contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Private non-profit"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Private non-profit"],"otherSponsorType":[""]},"governance":{"committee":true},"collaborations":{"networkConsortium":true},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":true,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Weekly collection of data on electronic CRFs by research technicians based on medical records","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"Hospitals in Bourgogne-Franche-Comt\u00e9: Besan\u00e7on, M\u00e2con, Montb\u00e9liard, Vesoul, Auxerre, D\u00f4le, Sens, Dijon, Chalon-sur-Sa\u00f4ne"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"Creatinineemia, proteinuria, calciumemia, phosphoremia, HbA1c, hemoglobin, vitamin D3, PTH, iron, ferritin, urea, uricemia","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}