{"doc_desc":{"title":"Case-Control Study on Narcolepsy Risk Factors Following Exposure to Anti-H1N1 Vaccines","idno":"FRESH-PEF73060-en","producers":[{"name":"Antoine PARIENTE","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73060-en","IDno":{"metadata_no":[{"agency":"PEF","code":"73060"},{"agency":"FReSH","code":"FRESH-PEF73060"}]},"title":"Case-Control Study on Narcolepsy Risk Factors Following Exposure to Anti-H1N1 Vaccines","alternate_title":"NarcoFluVF"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Yves;DAUVILLIERS","PILabo":"Montpellier University Hospital \/ National Reference Centre for Narcolepsy\/Sleep Laboratory","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE MONTPELLIER (CHU)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"083667555","role":"pi id"},{"title":"SIREN","uri":"263400160","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"y-dauvilliers@chu-montpellier.fr","isContact":"Yes"},{"type":"investigator","name":"Antoine;PARIENTE","PILabo":"Inserm, Bordeaux University Hospital \/ Pharmacoepidemiology","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ORCID","uri":"0000-0002-7873-5483","role":"pi id"},{"title":"IdRef","uri":"13395711X","role":"pi id"},{"title":"SIREN","uri":"180036048","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"antoine.pariente@u-bordeaux.fr","isContact":"Yes"}],"oth_id":[{"name":"VAESCO European Project","type":"collaboration"}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"sponsor id"},{"title":"SIREN","uri":"180036048","role":"sponsor id"}],"role":"sponsor"},{"name":"UNIVERSITE DE BORDEAUX","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/057qpr032","role":"sponsor id"},{"title":"SIREN","uri":"130018351","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"AGENCE NATIONALE DE SECURITE DU MEDICAMENT ET DES PRODUITS DE SANTE (ANSM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01g80gk13"},{"title":"SIREN","uri":"180036113"}]},{"name":"EUROPEAN CENTRE FOR DISEASE PREVENTION AND CONTROL","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00s9v1h75"}]}]},"distribution_statement":{"contact":[{"name":"Yves;DAUVILLIERS","email":"y-dauvilliers@chu-montpellier.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE MONTPELLIER (CHU)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00mthsf17","role":"organisation id","title":"ROR"},{"uri":"263400160","role":"organisation id","title":"SIREN"}]},{"name":"Antoine;PARIENTE","email":"antoine.pariente@u-bordeaux.fr","type":"contact","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id","title":"ROR"},{"uri":"180036048","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"narcolepsy"},{"keyword":"H1N1"},{"keyword":"influenza"},{"keyword":"vaccines"},{"keyword":"exposure"}],"topics":[{"topic":"Infectious disease medicine","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/fa2ceeab-3b2f-45e9-9243-e5a8005b98de"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D055552"}]},{"topic":"Neurology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/c4793dfe-e80e-49dd-9fcc-a1a742de1b25"},{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/00a5c4f4-b7ee-41a4-bcdf-3a02e6be1660"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D009462"}]},{"topic":"Narcolepsy","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1201727099","title":"CIM-11"}]},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"The main aim of the study was to determine the risk factors for narcolepsy; particularly focussing on the potential impact of influenza, H1N1 infection and vaccination (especially against the H1N1 influenza pandemic). As such, the study was able to contribute to the European study coordinated by the VAESCO consortium and received funding from the ECDC. The secondary aim was to compare the characteristics of exposed and unexposed cases. The potential impact of genetic susceptibility is not outlined in the final report (depending on the analyses that will potentially be carried out on stored samples).","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":"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\": \"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\": \"Cases were defined as patients diagnosed with narcolepsy; validated and classed according to the Brighton Classification Criteria by an approval committee; with an index date between 01\\\/04\\\/2009 and 30\\\/04\\\/2011, and where the onset of excessive daytime sleepiness (EDS) occurred before 31\\\/12\\\/2004.  Controls: Patients of the same age, sex and treated at the same centre as the case subject. Treatment unrelated to narcolepsy or anti-H1N1 vaccination.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Participant-reported health 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"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"< 500 individuals","response_rate":"Case: 85; Controls: 202"},"method_notes":"Observational Study","study_class":"Completed study","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Case-control 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":"","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":"05-05-2015","lastUpdatedAuto":null,"lastUpdatedManual":"05-07-2016","isContributorPI":"No","contributorName":"Antoine PARIENTE","contributorAffiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/?term=narcoflu"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (Europe)"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Public (France)","Public (France)"],"otherSponsorType":["",""]},"governance":{"committee":"Yes"},"collaborations":{"networkConsortium":"Yes"},"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":"Face-to-face questionnaire for cases and by phone for cases and controls.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"14 centres across France."},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"Blood sample (HLA-DQB1 typing, genetic and antibody analyses).","isDataInBiobank":"Yes","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}