{"doc_desc":{"title":"Cohorte des 1000 m\u00e9nages pour le suivi de la pand\u00e9mie de grippe H1N1","idno":"FRESH-PEF60168-fr","producers":[{"name":"Fabrice CARRAT","affiliation":"SORBONNE UNIVERSITE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60168-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60168"},{"agency":"FReSH","code":"FRESH-PEF60168"}]},"title":"Cohorte des 1000 m\u00e9nages pour le suivi de la pand\u00e9mie de grippe H1N1","alternate_title":"COPANFLU"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CPP"}]},"authoring_entity":[{"type":"investigator","name":"Antoine;FLAHAULT","PILabo":"EHESP \/ ECOLE DES HAUTES ETUDES EN SANT\u00c9 PUBLIQUE","affiliationName":"ECOLE DES HAUTES ETUDES EN SANTE PUBLIQUE (EHESP)","extlink":[{"title":"ORCID","uri":"0000-0002-6957-2977","role":"pi id"},{"title":"IdRef","uri":"035602031","role":"pi id"},{"title":"SIREN","uri":"130003627","role":"organisation id"},{"title":"RNSR","uri":"201521285A","role":"labo id"}],"email":"antoine.flahault@unige.ch","isContact":"Oui"},{"type":"investigator","name":"Fabrice;CARRAT","PILabo":"Universit\u00e9 Paris 6 et \/ UMR-S 707 - \u00c9pid\u00e9miologie, mod\u00e9lisation syst\u00e8mes d'information","affiliationName":"SORBONNE UNIVERSITE","extlink":[{"title":"ORCID","uri":"0000-0002-8672-7918","role":"pi id"},{"title":"IdRef","uri":"061656720","role":"pi id"},{"title":"SIREN","uri":"130023385","role":"organisation id"},{"title":"RNSR","uri":"201420917E","role":"labo id"}],"email":"fabrice.carrat@iplesp.upmc.fr","isContact":"Oui"}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"ECOLE DES HAUTES ETUDES EN SANTE PUBLIQUE (EHESP)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01sc83v92","role":"sponsor id"},{"title":"SIREN","uri":"130003627","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"ECOLE DES HAUTES ETUDES EN SANTE PUBLIQUE (EHESP)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01sc83v92"},{"title":"SIREN","uri":"130003627"}]},{"name":"INSTITUT DE RECHERCHE POUR LE DEVELOPPEMENT (IRD)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/05q3vnk25"},{"title":"SIREN","uri":"180006025"}]}]},"distribution_statement":{"contact":[{"name":"Antoine;FLAHAULT","email":"antoine.flahault@unige.ch","type":"contact","affiliationName":"ECOLE DES HAUTES ETUDES EN SANTE PUBLIQUE (EHESP)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/01sc83v92","role":"organisation id","title":"ROR"},{"uri":"130003627","role":"organisation id","title":"SIREN"}]},{"name":"Fabrice;CARRAT","email":"fabrice.carrat@iplesp.upmc.fr","type":"contact","affiliationName":"SORBONNE UNIVERSITE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02en5vm52","role":"organisation id","title":"ROR"},{"uri":"130023385","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"infections"},{"keyword":"virus A(H1N1)"},{"keyword":"syndromes infectieux respiratoires"},{"keyword":"infection"},{"keyword":"\u00e9v\u00e9nements de sant\u00e9"},{"keyword":"complications"}],"topics":[{"topic":"Infectiologie","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":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux : Autres","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux","vocab":"health determinant"}],"purpose":"Objectif g\u00e9n\u00e9ral : Identifier au niveau de l\u2019individu les d\u00e9terminants \u00e9pid\u00e9miologiques, environnementaux, immunologiques, sociaux, g\u00e9n\u00e9tiques et virologiques du risque d\u2019infection grippale par le virus A (H1N1)-swine-like (SWL) Objectifs secondaires : - d\u00e9crire l\u2019impact en sant\u00e9 publique en termes de morbidit\u00e9, de complications, de consommation de ressources en sant\u00e9 de l\u2019infection par le A(H1N1)-SWL ; - caract\u00e9riser l\u2019histoire \u00abnaturelle\u00bb de l\u2019infection et sa variabilit\u00e9 interindividuelle ; identifier les voies de la transmission ; - \u00e9tudier les d\u00e9terminants individuels et collectifs d\u2019une expression clinique variable de l\u2019infection ; - \u00e9tudier les modifications de comportements induites par une pand\u00e9mie et \u00e9valuer le niveau de perception du risque, son \u00e9volution dans le temps ; - \u00e9valuer la p\u00e9n\u00e9trance, l\u2019application et l\u2019efficacit\u00e9 des mesures de contr\u00f4le mises en place (traitement, vaccin, mesures barri\u00e8res) ; - caract\u00e9riser l\u2019immunit\u00e9 homotypique, h\u00e9t\u00e9rosubtypique en fonction de l\u2019\u00e2ge \u2013 \u00e9valuer l\u2019immunit\u00e9 gr\u00e9gaire et \u00e9tudier l\u2019immunit\u00e9 cellulaire inn\u00e9e et acquise cons\u00e9cutivement \u00e0 une infection par ce virus ; - caract\u00e9riser la diversit\u00e9 virale et les m\u00e9canismes \u00e9volutifs du virus A(H1N1)-SWL ; \u00e9tudier la survenue de r\u00e9sistance aux traitements - construire et tester des mod\u00e8les d\u2019anticipation en temps r\u00e9el de l\u2019impact de la pand\u00e9mie sur la population et simuler diff\u00e9rents sc\u00e9narios de contr\u00f4le.","abstract":"","coll_dates":[{"start":"2009-01-01","end":"2012-01-01"}],"nation":[{"name":"Bolivie, l'\u00e9tat plurinational de","abbreviation":"bo","extLink":{"vocab":"ISO","vocabURI":"bo"}},{"name":"Lao, r\u00e9publique d\u00e9mocratique populaire","abbreviation":"la","extLink":{"vocab":"ISO","vocabURI":"la"}},{"name":"Mali","abbreviation":"ml","extLink":{"vocab":"ISO","vocabURI":"ml"}},{"name":"Cameroun","abbreviation":"cm","extLink":{"vocab":"ISO","vocabURI":"cm"}},{"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\": \"Population g\u00e9n\u00e9rale\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"M\u00e9nages volontaires domicili\u00e9s sur le territoire m\u00e9tropolitain dont les membres ont tous valid\u00e9 un consentement pour participer \u00e0 cette cohorte (pour les enfants, le consentement des parents plus celui des enfants, facultatif s\u2019ils ont plus de 7 ans et obligatoire s\u2019ils ont plus de  13 ans) ; b\u00e9n\u00e9ficiant d\u2019une couverture par l\u2019assurance maladie ; parlant et \u00e9crivant fran\u00e7ais ; disposant d\u2019une ligne t\u00e9l\u00e9phonique.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es biologiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Pr\u00e9sence d\\'une requ\u00eate de coh\u00e9rence au moment de la saisie des donn\u00e9es informatiques et apr\u00e8s la saisie des donn\u00e9es informatiques.Gestion des donn\u00e9es manquantes par retour vers le patient. Relance des sujets pour r\u00e9aliser les visites de suivi.Autres proc\u00e9dures qualit\u00e9 pour tous les circuits (data et collections biologiques).Les patients sont inform\u00e9s de l\\'utilisation de leur donn\u00e9es.']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nEv\u00e9nements de sant\u00e9\/mortalit\u00e9"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Base de population \u00e0 finalit\u00e9 statistique']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Questionnaire auto-administr\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":"[1000-10000[ individus","response_rate":"1451"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Cohorte"]}]},"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":"Selon Charte IRESP et convention INSERM\/EHESP","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":"08-03-2013","lastUpdatedAuto":null,"lastUpdatedManual":"14-08-2014","isContributorPI":"Non","contributorName":"Fabrice CARRAT","contributorAffiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[{"type":"","title":"List of publications in HAL","link":"http:\/\/www.hal.inserm.fr\/COPANFLU"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":"Oui"},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Oui","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Auto-questionnaire : saisie \u00e0 partir d\u2019un questionnaire papier avec double saisie Entretiens : saisie \u00e0 partir d\u2019un questionnaire papier avec double saisie Examens biologiques : saisie directe","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Etude Internationale impliquant : Bolivie, Laos, Mali, Cameroun (non limitative) Couverture g\u00e9ographique : nationale (pour le protocole France)"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"Type de pr\u00e9l\u00e8vements r\u00e9alis\u00e9s : pr\u00e9l\u00e8vements de cellules et de s\u00e9rumsA l'inclusion, apr\u00e8s vaccination \u00e9ventuelle et 2 fois par an","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}