{"doc_desc":{"title":"Enqu\u00eate Observatoire des Maladies Rares 2011","idno":"FRESH-PEF8427-fr","producers":[{"name":"Thomas HEUYER","affiliation":"MALADIES RARES INFO SERVICES"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF8427-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"8427"},{"agency":"FReSH","code":"FRESH-PEF8427"}]},"title":"Enqu\u00eate Observatoire des Maladies Rares 2011","alternate_title":""},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CPP"}]},"authoring_entity":[{"name":"Thomas;HEUYER","firstname":"Thomas","lastname":"HEUYER","type":"investigator","extlink":[{"title":"SIREN","uri":"440803724","role":"organisation id"}],"email":"theuyer@maladiesrares.org","affiliationName":"MALADIES RARES INFO SERVICES","PILabo":"Maladies Rares Info \/ Observatoire des Maladies Rares","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"MALADIES RARES INFO SERVICES","extlink":[{"title":"SIREN","uri":"440803724","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"ASS FRANCAISE CONTRE LES MYOPATHIES (AFM)","extlink":[{"title":"SIREN","uri":"775609571"}]},{"name":""}]},"distribution_statement":{"contact":[{"name":"Thomas;HEUYER","lastname":"HEUYER","firstname":"Thomas","type":"contact","email":"theuyer@maladiesrares.org","affiliationName":"MALADIES RARES INFO SERVICES","contactPointLabo":"","extlink":[{"uri":"440803724","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Affectation Longue Dur\u00e9e"},{"keyword":"ALD"},{"keyword":"errance diagnostique"},{"keyword":"acc\u00e8s information"},{"keyword":"frais \u00e0 charge du patients"},{"keyword":"renoncement aux soins"},{"keyword":"prise en charge"}],"topics":[],"purpose":"L\u2019objectif de l\u2019Observatoire est de mettre \u00e0 disposition de l\u2019ensemble des acteurs mobilis\u00e9s dans la lutte contre les maladies rares des donn\u00e9es fiables mettant en exergue des probl\u00e9matiques importantes auxquelles sont confront\u00e9s les personnes malades et leurs proches. Ces donn\u00e9es doivent permettre non seulement de bien cerner ces probl\u00e9matiques mais \u00e9galement d\u2019avancer des propositions pour y rem\u00e9dier. Cette enqu\u00eate \u00e9tudie trois th\u00e9matiques : - l\u2019errance diagnostique ; - l\u2019acc\u00e8s \u00e0 l\u2019information ; - la prise en charge financi\u00e8re des soins, produits et prestations.","abstract":"","coll_dates":[{"start":"2011-01-01","end":"2012-01-01"}],"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\": \"Nouveau-n\u00e9 (naissance \u00e0 28j)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007231\"\n            }\n        },\n        {\n            \"value\": \"Nourrisson (28j \u00e0 2 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007223\"\n            }\n        },\n        {\n            \"value\": \"Petite enfance (2 \u00e0 5 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002675\"\n            }\n        },\n        {\n            \"value\": \"Enfance (6 \u00e0 12 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        },\n        {\n            \"value\": \"Adolescence (13 \u00e0 18 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000293\"\n            }\n        },\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\": \" Statut : les personnes malades, leurs conjoints, leurs enfants ou leurs parents. - Pathologie : pr\u00e9valence inf\u00e9rieure ou \u00e9gale \u00e0 une personne sur 2000, conform\u00e9ment aux donn\u00e9es pr\u00e9sent\u00e9es dans le cahier Orphanet sur la pr\u00e9valence des maladies rares. - En l\u2019absence de diagnostic : dans une telle situation, soit la personne malade \u00e9tait susceptible d\u2019\u00eatre touch\u00e9e par une maladie rare, soit la situation \u00e9voqu\u00e9e renvoyait \u00e0 de l\u2019hypocondrie, affabulation... C\u2019\u00e9tait \u00e0 la Charg\u00e9e d\u2019Ecoute et d\u2019Information (CEI)d\u2019appr\u00e9cier si la situation \u00e9voqu\u00e9e par l\u2019appelant relevait de la premi\u00e8re ou de la seconde hypoth\u00e8se et m\u00e9ritait de faire l\u2019objet ou non d\u2019un recueil de donn\u00e9es\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nConsommation de soins\/services de sant\u00e9\r\nQualit\u00e9 de vie\/sant\u00e9 per\u00e7ue"}]},"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":"['Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"< 500 individus","response_rate":"198 individuals out of the 361 asked participated in the quantitative survey. (322 individuals participated in the qualitative study allowing to build the quantitative questionnaire)"},"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":"18-03-2014","lastUpdatedAuto":null,"lastUpdatedManual":"09-05-2014","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.maladiesraresinfo.org\/services-proposes\/89.html"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Priv\u00e9 \u00e0 but non lucratif","Priv\u00e9 \u00e0 but non lucratif"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Priv\u00e9 \u00e0 but non lucratif"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":true},"activeFollowUp":{"isActiveFollowUp":false,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":false,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}