{"doc_desc":{"title":"Epidemiology Network and Nephrology Information Registry (qualified registry 2012-2015)","idno":"FRESH-PEF5623-en","producers":[{"name":"Christian JACQUELINET","affiliation":"AGENCE DE LA BIOMEDECINE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF5623-en","IDno":{"metadata_no":[{"agency":"PEF","code":"5623"},{"agency":"FReSH","code":"FRESH-PEF5623"}]},"title":"Epidemiology Network and Nephrology Information Registry (qualified registry 2012-2015)","alternate_title":"REIN"},"study_authorization":{"agency":[]},"authoring_entity":[{"name":"Christian;JACQUELINET","firstname":"Christian","lastname":"JACQUELINET","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03tajza86","role":"organisation id"},{"title":"SIREN","uri":"180092587","role":"organisation id"}],"email":"christian.jacquelinet@biomedecine.fr","affiliationName":"AGENCE DE LA BIOMEDECINE","PILabo":"Agence de la biomedecine \/ Direction M\u00e9dicale et Scientifique","isContact":true}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"production_statement":{"prod_place":"Epidemiology France Portal (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","lastname":"COUCHOUD","firstname":"C\u00e9cile","type":"contact","email":"cecile.couchoud@biomedecine.fr","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","lastname":"JACQUELINET","firstname":"Christian","type":"contact","email":"christian.jacquelinet@biomedecine.fr","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":"Data"},{"keyword":"interpretation"},{"keyword":"decision"},{"keyword":"epidemiological expertise"},{"keyword":"biostatistics"},{"keyword":"transplanted or dialysis patients"},{"keyword":"rate of mortality and progression"},{"keyword":"comorbidities"},{"keyword":"associated disabilities"},{"keyword":"incidence"},{"keyword":"prevalence"},{"keyword":"sociodemographic characteristics"},{"keyword":"support"}],"topics":[{"topic":"Nephrology","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":"Kidney failure","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/761526554","title":"CIM-11"}]},{"topic":"Socio-demographic and economic determinants","vocab":"health determinant"},{"topic":"Biological determinants: Genetic predisposition","vocab":"health determinant"},{"topic":"Environmental determinants: Other","vocab":"health determinant"},{"topic":"Behavioral determinants","vocab":"health determinant"},{"topic":"Biological determinants","vocab":"health determinant"},{"topic":"Environmental determinants","vocab":"health determinant"}],"purpose":"To establish a sustainable information system by unifying data, its interpretation and potential use for public health decision-making or clinical practice for all partners involved (network organisation) and to organise epidemiological knowledge, biostatistics and data necessary to: - Estimate the number of dialysis or transplant patients for chronic renal disease in France and overseas territories, - Assess the impact (Objective 80 of Public Health Law), prevalence, mortality rates and trends in chronic renal disease at regional level, patient sociodemographic characteristics, baseline renal disease, comorbidities and associated disabilities - Specifically describe dialysis treatment modalities (method, modality, dose) and changing tendencies towards population requirements and medical practices - Evaluate relative aspects of different dialysis and transplantation modalities and to describe patient trajectories through these treatment modalities - Assess quality and efficacy of care in terms of early detection, dialysis dose, control of anaemia and nutritional balance, particularly with regard to good clinical practice - Evaluate patients' quality of life (Objective 81 of Public Health Law); - Evaluate the medical and economic outcomes of health care practices.","abstract":"","coll_dates":[{"start":"2003-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\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\": \"Infant, Newborn (birth to 28 days)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007231\"\n            }\n        },\n        {\n            \"value\": \"Infant (28 days to 2 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007223\"\n            }\n        },\n        {\n            \"value\": \"Child, Preschool (2 to 5 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002675\"\n            }\n        },\n        {\n            \"value\": \"Child (6 to 12 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        },\n        {\n            \"value\": \"Young Adult (19 to 24 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adult (25 to 44 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Middle Aged (45 to 64 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Aged (65 to 79 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Aged, 80 and over (80 years and more)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Initiation of treatment (dialysis or transplant) for End-Stage Renal Disease (ESRD).\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Biological data','Socio-demographic data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth event\/mortality"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":""}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Recording\",\"vocab\":\"CESSDA\"},\"value\":\"Recording (audio, video, electrophysiological, imaging)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":">= 20000 individuals","response_rate":"Au 31\/12\/2012 : 90685- 10048 nouveaux cas- 73491 patients trait\u00e9s- 7146 d\u00e9c\u00e8s"},"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\"}]}"},"dataset_use":{"restrictions":"","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"08-03-2013","lastUpdatedAuto":null,"lastUpdatedManual":"06-09-2017","isContributorPI":false,"contributorName":"","contributorAffiliation":"","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":true},"collaborations":{"networkConsortium":""},"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":"An epidemiological research support structure and recruitment of clinical research associates are the conditions imposed by REIN for all regions in the network. Clinical research associate responsibilities have three parts: - continuous completeness checks for new patient registration, events and annual follow-ups, which must take place throughout the year. Clinical research associates may temporarily participate in inputting recorded data completed by physicians into the information system from time to time. - Annual information quality control for all patients is carried out every first quarter before being sent for validation at national level. However, this is only for a limited number of items deemed essential that were collected during the previous year. - Ad hoc checks on patient samples for other data.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"Metropolitan France, overseas countries and territories"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"Activity 17% Serum Creatinine, Serum Haemoglobin, Serum Albumin, Glomerular filtration rate, Serum Creatinine 19% CNR - Qualification record 2008 14\/65 Serum Haemoglobin, Serum Albumin, Serum Erythropoietin","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}