{"doc_desc":{"title":"Quavi-REIN: Volet Dialyse","idno":"FRESH-PEF73133-fr","producers":[{"name":"Serge BRIAN\u00c7ON","affiliation":"CENTRE HOSPITALIER REGIONAL ET UNIVERSITAIRE DE NANCY"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73133-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73133"},{"agency":"FReSH","code":"FRESH-PEF73133"}]},"title":"Quavi-REIN: Volet Dialyse","alternate_title":"Quavi-REIN"},"study_authorization":{"agency":[{"name":"CNIL"}]},"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":"Oui"},{"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":"Oui"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (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":"Insuffisance r\u00e9nale chronique terminale"},{"keyword":"Dialyse"},{"keyword":"Transplantation r\u00e9nale"},{"keyword":"Enqu\u00eate transversale"},{"keyword":"Qualite de vie"},{"keyword":"Activite professionnelle"}],"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":"Maladie r\u00e9nale chronique, stade 5","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/820638928","title":"CIM-11"}]},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"},{"topic":"Autre","vocab":"health determinant"}],"purpose":"Objectifs principaux N\u00b01 \u2013 D\u00e9crire les principales caract\u00e9ristiques m\u00e9dicales, de sant\u00e9 et de prise en charge et la qualit\u00e9 de vie des patients adultes atteints d\u2019insuffisance r\u00e9nale chronique terminale (IRCT) en dialyse, porteurs d\u2019un greffon fonctionnel depuis au moins un an ou ayant un parcours th\u00e9rapeutique complexe. N\u00b02 - D\u00e9crire l\u2019\u00e9volution de son niveau entre 2005-2007 et 2011 de la qualit\u00e9 de vie et les principales caract\u00e9ristiques du patient et de sa prise en charge identifi\u00e9es comme associ\u00e9es \u00e0 la qualit\u00e9 de vie dans les volets 2005-2007. La finalit\u00e9 de l\u2019\u00e9tude est de fournir les indications au suivi du plan \u00ab am\u00e9lioration de la qualit\u00e9 de vie dans les maladies chroniques \u00bb et de l\u2019objectif 81 de la loi de sant\u00e9 publique d\u2019ao\u00fbt 2004. Objectifs secondaires n\u00b01 Appr\u00e9cier le b\u00e9n\u00e9fice de qualit\u00e9 de vie apport\u00e9 par la transplantation r\u00e9nale par rapport \u00e0 la dialyse. n\u00b02 Identifier s\u2019il existe une diff\u00e9rence de r\u00e9sultats en terme de qualit\u00e9 de vie entre les sujets greff\u00e9s par donneur cadav\u00e9rique et par donneur vivant. n\u00b03 Rechercher d\u2019\u00e9ventuelles disparit\u00e9s r\u00e9gionales ou inter r\u00e9gionales quant aux principales caract\u00e9ristiques des patients susceptibles d\u2019influencer le niveau de qualit\u00e9 de vie et v\u00e9rifier si il existe des diff\u00e9rences d\u2019\u00e9volution de ces caract\u00e9ristiques au cours de la p\u00e9riode. n\u00b04 D\u00e9crire certaines caract\u00e9ristiques des patients dialys\u00e9s, transplant\u00e9s ou ayant un parcours th\u00e9rapeutique complexe au regard des th\u00e9matiques importantes pour le plan qualit\u00e9 de vie des maladies chroniques : o maintien ou reprise d\u2019une activit\u00e9 professionnelle (fait l\u2019objet d\u2019un rapport sp\u00e9cifique pr\u00e9sent\u00e9 par l\u2019association RENALOO) o maintien ou reprise d\u2019une activit\u00e9 physique o qualit\u00e9 de l\u2019information re\u00e7ue sur les alternatives th\u00e9rapeutiques et participation aux choix des d\u00e9cisions de traitement (fait l\u2019objet d\u2019un rapport sp\u00e9cifique pr\u00e9sent\u00e9 par Mme le Professeur Corinne Isnard Bagnis) n\u00b05 Identifier s\u2019il existe une diff\u00e9rence de r\u00e9sultats en termes de qualit\u00e9 de vie entre les sujets dialys\u00e9s (jamais greff\u00e9s) et les sujets ayant un parcours th\u00e9rapeutique complexe.","abstract":"","coll_dates":[{"start":"","end":"2011-01-01"}],"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\": \"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\": \"Population source: ensemble des patients r\u00e9sidant en France et r\u00e9pondant aux crit\u00e8res d\u2019\u00e9ligibilit\u00e9 suivants :  - \u00eatre \u00e2g\u00e9 de 18 ans et plus,  - dialys\u00e9 ou porteur d\u2019un greffon r\u00e9nal fonctionnel depuis au moins un an et suivi dans l\u2019une des 21 r\u00e9gions participantes \u00e0 REIN au moment de l\u2019enqu\u00eate.   Au 31 d\u00e9cembre 2009, 26 820 personnes en dialyse et 19 950 personnes porteuses d\u2019un greffon r\u00e9nal fonctionnel etaient enregistr\u00e9es dans les syst\u00e8mes REIN et CRISTAL et r\u00e9pondaient \u00e0 ces crit\u00e8res d\u2019\u00e9ligibilit\u00e9.   Un \u00e9chantillon de 6 061  \u00e9ligibles a \u00e9t\u00e9 tir\u00e9 au sort en stratifiant sur la r\u00e9gion et sur l\u2019\u00e2ge.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es socio-d\u00e9mographiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[]},"method":{"data_collection":{"time_method":"Etude transversale non r\u00e9p\u00e9t\u00e9e","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Base m\u00e9dico-administrative (de patients, Assurance Maladie\/Mutuelle) Registre de maladies, de d\u00e9c\u00e8s']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Questionnaire auto-administr\u00e9\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"1 251 personnes dialys\u00e9es et 1 658 personnes greff\u00e9es"},"method_notes":"Etude observationnelle","study_class":"\u00c9tude compl\u00e9t\u00e9e","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"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":"02-07-2015","lastUpdatedAuto":null,"lastUpdatedManual":"13-09-2017","isContributorPI":"Non","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":"Oui"},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Non","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Enquete par auto-questionnaire envoy\u00e9 au domicile des personnes","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"France metroplitaine et La Reunion"},"dataTypes":{"clinicalDataDetails":"S\u00e9lection de donn\u00e9es issues des registres REIN et CRISTAL","biologicalDataDetails":"","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}