{"doc_desc":{"title":"National Representative Sample of people with diabetes 2007-2010","idno":"FRESH-PEF7786-en","producers":[{"name":"Sandrine FOSSE-EDORH","affiliation":"SANTE PUBLIQUE FRANCE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF7786-en","IDno":{"metadata_no":[{"agency":"PEF","code":"7786"},{"agency":"FReSH","code":"FRESH-PEF7786"}]},"title":"National Representative Sample of people with diabetes 2007-2010","alternate_title":"Entred 2007-2010"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Sandrine;FOSSE-EDORH","PILabo":"Sant\u00e9 publique France","affiliationName":"SANTE PUBLIQUE FRANCE","extlink":[{"title":"ORCID","uri":"0000-0002-0105-5551","role":"pi id"},{"title":"IdRef","uri":"254010202","role":"pi id"},{"title":"SIREN","uri":"130022338","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"Sandrine.fosse@santepubliquefrance.fr","isContact":"Yes"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"SANTE PUBLIQUE FRANCE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00dfw9p58","role":"sponsor id"},{"title":"SIREN","uri":"130022338","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"CAISSE NATIONALE DE L'ASSURANCE MALADIE (CNAM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03am7sg53"},{"title":"SIREN","uri":"180035024"}]},{"name":"HAUTE AUTORITE DE SANTE (HAS)","extlink":[{"title":"SIREN","uri":"110000445"}]},{"name":"SANTE PUBLIQUE FRANCE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00dfw9p58"},{"title":"SIREN","uri":"130022338"}]}]},"distribution_statement":{"contact":[{"name":"Sandrine;FOSSE-EDORH","email":"Sandrine.fosse@santepubliquefrance.fr","type":"contact","affiliationName":"SANTE PUBLIQUE FRANCE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00dfw9p58","role":"organisation id","title":"ROR"},{"uri":"130022338","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"type 1 diabetes"},{"keyword":"vascular risk"},{"keyword":"socioeconomic level"},{"keyword":"socioeconomic status"},{"keyword":"educational measures"},{"keyword":"quality of care"},{"keyword":"cost"},{"keyword":"type 2 diabetes"},{"keyword":"characteristics"},{"keyword":"complication"},{"keyword":"hospitalisation"},{"keyword":"mortality"}],"topics":[{"topic":"Endocrinology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/d1dd1bac-5313-4ab3-837f-4acd3ec521a7"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D004704"}]},{"topic":"Diabetes mellitus, type unspecified","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1697306310","title":"CIM-11"}]},{"topic":"Behavioral determinants","vocab":"health determinant"}],"purpose":"To describe the characteristics of people pharmacologically treated for diabetes, their health with regards to diabetes, the quality of care received, treatment plan and self-management education; their quality of life, experiences and requirements in terms of education and information, as well as the cost of diabetes.","abstract":"","coll_dates":[{"start":"2006-01-01","end":"2009-01-01"}],"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\": \"Beneficiaries of the French general scheme of health insurance (CNAMTS) (excluding local mutualist sections) and the Independent Scheme for employees (RSI); residing in mainland France or overseas d\u00e9partements (DOM); and who have received at least three reimbursements for oral antidiabetic medications and\\\/or insulin over the last twelve months.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological data','Socio-demographic data']","quality_statement":{"standards":[{"name":"['CIM 10.']","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth event\/mortality\r\nHealth care consumption and services\r\nQuality of life\/health perception"}]},"method":{"data_collection":{"time_method":"Repeated 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\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[1000-10000[ individuals","response_rate":"8,000 people in metropolitan France, 800 people from overseas d\u00e9partements and 850 children."},"method_notes":"Observational Study","study_class":"Unknown","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":"Data are available to external teams after project is submitted to an assessment committee.","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":"18-12-2013","lastUpdatedAuto":null,"lastUpdatedManual":"01-07-2019","isContributorPI":"No","contributorName":"Sandrine FOSSE-EDORH","contributorAffiliation":"SANTE PUBLIQUE FRANCE","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)","Public (France)"],"otherFundingAgentType":["","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Data collected by self-administered questionnaire, phone questionnaire and physician questionnaire, combined with passive medical and administrative data collection (medical consumption and hospitalisation) and mortality data (vital status and cause of death).","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"Medical questionnaire sent to attending physicians.","biologicalDataDetails":"Medical questionnaire sent to physicians.","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}