{"doc_desc":{"title":"Quavi-REIN: Dialysis Section","idno":"FRESH-PEF73133-en","producers":[{"name":"Serge BRIAN\u00c7ON","affiliation":"CENTRE HOSPITALIER REGIONAL ET UNIVERSITAIRE DE NANCY"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73133-en","IDno":{"metadata_no":[{"agency":"PEF","code":"73133"},{"agency":"FReSH","code":"FRESH-PEF73133"}]},"title":"Quavi-REIN: Dialysis Section","alternate_title":"Quavi-REIN"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Serge;BRIAN\u00c7ON","PILabo":"CHU de Nancy, Unit QSP2, Clinical Evaluation and Epidemiology \/ EA4360, APEMAC","affiliationName":"CENTRE HOSPITALIER REGIONAL ET UNIVERSITAIRE DE NANCY","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"060570520","role":"pi id"},{"title":"SIREN","uri":"200042166","role":"organisation id"},{"title":"RNSR","uri":"200918432A","role":"labo id"}],"email":"serge.briancon@univ-lorraine.fr","isContact":"Yes"},{"type":"investigator","name":"Stephanie;GENTILE","PILabo":"University of Aix-Marseille, Faculty of Medecine \/ SPMC EA 3279, Public health laboratory","affiliationName":"UNIVERSITE D'AIX MARSEILLE","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"085610461","role":"pi id"},{"title":"SIREN","uri":"130015332","role":"organisation id"},{"title":"RNSR","uri":"200014577Z","role":"labo id"}],"email":"stephanie.gentile@ap-hm.fr","isContact":"Yes"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"CENTRE HOSPITALIER REGIONAL ET UNIVERSITAIRE DE NANCY","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/016ncsr12","role":"sponsor id"},{"title":"SIREN","uri":"200042166","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"AGENCE DE LA BIOMEDECINE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03tajza86"},{"title":"SIREN","uri":"180092587"}]},{"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":"Serge;BRIAN\u00c7ON","email":"serge.briancon@univ-lorraine.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER REGIONAL ET UNIVERSITAIRE DE NANCY","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/016ncsr12","role":"organisation id","title":"ROR"},{"uri":"200042166","role":"organisation id","title":"SIREN"}]},{"name":"Stephanie;GENTILE","email":"stephanie.gentile@ap-hm.fr","type":"contact","affiliationName":"UNIVERSITE D'AIX MARSEILLE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/035xkbk20","role":"organisation id","title":"ROR"},{"uri":"130015332","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"End stage renal disease"},{"keyword":"Kidney transplant"},{"keyword":"Cross-sectional survey"},{"keyword":"Professional activity"},{"keyword":"Dialysis"},{"keyword":"Quality of life"}],"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":"Chronic kidney disease, stage 5","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/820638928","title":"CIM-11"}]},{"topic":"Behavioral determinants","vocab":"health determinant"},{"topic":"Socio-demographic and economic determinants","vocab":"health determinant"}],"purpose":"Principal objectives No. 1 \u2013 To describe the principal medical, health, treatment and quality of life characteristics of adult patients with end stage renal disease (ESRD) undergoing dialysis, who have had a functional transplant at least one year prior or who have a complex therapeutic path. No. 2 \u2013 To describe the evolution between 2005-2007 and 2011 of the patient's quality of life and principal characteristics and their treatment, identified as associated with quality of life in the 2005-2007 sections. The purpose of the study is to provide instructions for monitoring of the \"quality of life improvement in chronic diseases\" plan and of objective 81 of the public health act dated 2004. Secondary objectives No. 1 To assess the quality of life benefit provided by the kidney transplant compared to dialysis. No. 2 To identify if there is a difference in quality of life results between subjects receiving transplants from dead donors and living donors. No. 3 To research any regional or inter-regional disparities in the principal characteristics of patients that are likely to influence the quality of life level and to check whether there are any differences in the evolution of these characteristics over the course of the period. No. 4 To describe certain characteristics of patients undergoing dialysis, receiving transplants or having a complex therapeutic path in relation to the important topics for the chronic diseases quality of life plan: o maintenance or resumption of a professional activity (subject of a specific report submitted by the RENALOO association) o maintenance or resumption of a physical activity o quality of the information received about therapeutic alternatives and participation in treatment decisions (subject of a specific report submitted by Prof. Isnard Bagnis) No. 5 To identify if there is a difference in the quality of life results between subjects undergoing dialysis (no transplant ever performed) and subjects having a complex therapeutic course.","abstract":"","coll_dates":[{"start":"","end":"2011-01-01"}],"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\": \"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\": \"Source population: all patients living in France who meet the following eligibility criteria:  - being 18 years of age or older  - person undergoing dialysis or recipient of a functional kidney transplant at least one year prior and monitored in one of the 21 regions participating in REIN at the time of the survey.   On 31 December 2009, 26,820 people undergoing dialysis and 19,950 recipients of a functional kidney transplant who met the eligibility criteria were registered in the REIN and CRISTAL systems.   A sample of 6,061 eligible individuals were randomly selected, stratified by the region and age.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Socio-demographic data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[]},"method":{"data_collection":{"time_method":"One-time cross-sectional study","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Medical-administrative database (patients, health insurance\/mutual insurance) Disease and death registry']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Self-administered questionnaire\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[1000-10000[ individuals","response_rate":"1,251 individuals undergoing dialysis and 1,658 transplant recipients"},"method_notes":"Observational Study","study_class":"Completed study","notes":[{"subject":"research type","values":["Observational Study"]}]},"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":"Contact the principal investigator","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":"02-07-2015","lastUpdatedAuto":null,"lastUpdatedManual":"13-09-2017","isContributorPI":"No","contributorName":"Serge BRIAN\u00c7ON","contributorAffiliation":"UNIVERSITE DE LORRAINE","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[{"type":"","title":"Numero special BEH - Vivre avec la dialyse ou la greffe r\u00e9nale \u2013 Enqu\u00eate Quavi-REIN, 2011","link":"http:\/\/www.invs.sante.fr\/beh\/2014\/37-38\/pdf\/2014_37-38.pdf"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":"Yes"},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"No","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Survey by self-questionnaire sent to individuals' homes","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"Metropolitan France and La Reunion"},"dataTypes":{"clinicalDataDetails":"Selection of data from the REIN and CRISTAL records","biologicalDataDetails":"","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}