{"doc_desc":{"title":"\u00c9tude internationale sur l'asthme et les allergies chez les enfants en France","idno":"FRESH-PEF8272-fr","producers":[{"name":"Isabella ANNESI-MAESANO","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF8272-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"8272"},{"agency":"FReSH","code":"FRESH-PEF8272"}]},"title":"\u00c9tude internationale sur l'asthme et les allergies chez les enfants en France","alternate_title":"ISAAC"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Isabella;ANNESI-MAESANO","firstname":"Isabella","lastname":"ANNESI-MAESANO","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id"},{"title":"SIREN","uri":"180036048","role":"organisation id"}],"email":"isabella.annesi-maesano@inserm.fr","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","PILabo":"Institut national de la sant\u00e9 et de la recherche m\u00e9dicale \/ U1136 INSTITUT PIERRE LOUIS D'EPIDEMIOLOGIE ET DE SANTE PUBLIQUE (IPLESP)","isContact":true}],"oth_id":[{"name":"Pendant p\u00e9diatrique de ECHRS.Le projet fait intervenir six services hospitaliers (Clermont-Ferrand, Marseille, Bordeaux, Reims, Strasbourg, Paris) et trois \u00e9quipes d\u2019experts :\u2022 \u00e9quipe d\u2019\u00e9pid\u00e9miologie : Dr I. Annesi-Maesano, G. Debotte, Inserm U 472), \u2022 \u00e9quipe de p\u00e9diatrie : Pr P. Scheinman, Dr C. Karila, Dr E. Paty (h\u00f4pital Necker-Enfants malades, Paris) ;\u2022 \u00e9quipe de m\u00e9trologie : M. Squinazi, Y Le Moullec, M. Laurent (laboratoire d\u2019hygi\u00e8ne de la ville de Paris).","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (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"}],"funding_agencies":[{"name":"AGENCE DE L ENVIRONNEMENT ET DE LA MAITRISE DE L ENERGIE (ADEME)","extlink":[{"title":"SIREN","uri":"385290309"}]},{"name":"FONDATION ENTREPRISE MGEN SANTE PUBLIQUE (FSP MGEN)","extlink":[{"title":"SIREN","uri":"444268627"}]},{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261"},{"title":"SIREN","uri":"180036048"}]},{"name":"MINISTERE DU TRAVAIL ET DES SOLIDARITES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/018k53h31"},{"title":"SIREN","uri":"110000072"}]}]},"distribution_statement":{"contact":[{"name":"Isabella;ANNESI-MAESANO","lastname":"ANNESI-MAESANO","firstname":"Isabella","type":"contact","email":"isabella.annesi-maesano@inserm.fr","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":"test cutan\u00e9"},{"keyword":"Enfant"},{"keyword":"environnement"},{"keyword":"pollution atmosph\u00e9rique"},{"keyword":"allergie"}],"topics":[{"topic":"Allergologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/af65e2bf-afc5-45e8-a0fc-364dfb48f0a4"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D000486"}]},{"topic":"P\u00e9diatrie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/bf8aaaac-ddee-41cd-bb8a-c5a63de3fcbd"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D010372"}]},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques : Pr\u00e9dispositions g\u00e9n\u00e9tiques","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques","vocab":"health determinant"}],"purpose":"Dresser une cartographie de la pr\u00e9valence mondiale des maladies allergiques infantiles et de pr\u00e9ciser, par la comparaison de groupes de population contrast\u00e9s du fait d\u2019une pr\u00e9valence particuli\u00e8rement forte ou faible, les facteurs de risque de ces affections. L\u2019\u00e9tude ISAAC comporte trois phases : La phase I a pour but de d\u00e9terminer, gr\u00e2ce \u00e0 l\u2019utilisation d\u2019un questionnaire simple et \u00e9ventuellement aussi d\u2019un vid\u00e9o questionnaire (dans le cas de l\u2019asthme), la pr\u00e9valence de l\u2019asthme, de la rhinite allergique et de l\u2019ecz\u00e9ma dans des \u00e9chantillons repr\u00e9sentatifs d\u2019enfants appartenant \u00e0 deux tranches d\u2019\u00e2ge : 13-14 ans (obligatoire pour tous les centres) et 6-7 ans (facultatif). La phase II, a pour objectif de pr\u00e9ciser, gr\u00e2ce \u00e0 l\u2019\u00e9tude plus approfondie de groupes de population s\u00e9lectionn\u00e9s en raison d\u2019un taux de pr\u00e9valence d\u2019allergies particuli\u00e8rement \u00e9lev\u00e9 ou faible lors de la phase I, les facteurs de risque des maladies allergiques et les modalit\u00e9s de leur prise en charge. La phase III vise \u00e0 \u00e9tudier l\u2019\u00e9volution de la pr\u00e9valence des allergies. \u00c0 cet effet, le protocole de la phase I sera r\u00e9p\u00e9t\u00e9 dans les zones ayant particip\u00e9 \u00e0 cette phase.","abstract":"","coll_dates":[{"start":"1999-01-01","end":"2000-01-01"}],"nation":[{"name":"Belize","abbreviation":"bz","extLink":{"vocab":"ISO","vocabURI":"bz"}},{"name":"Chine","abbreviation":"cn","extLink":{"vocab":"ISO","vocabURI":"cn"}},{"name":"Allemagne","abbreviation":"de","extLink":{"vocab":"ISO","vocabURI":"de"}},{"name":"Italie","abbreviation":"it","extLink":{"vocab":"ISO","vocabURI":"it"}},{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}},{"name":"Japon","abbreviation":"jp","extLink":{"vocab":"ISO","vocabURI":"jp"}},{"name":"Cor\u00e9e, r\u00e9publique populaire d\u00e9mocratique de","abbreviation":"kr","extLink":{"vocab":"ISO","vocabURI":"kr"}},{"name":"Ta\u00efwan, province de chine","abbreviation":"tw","extLink":{"vocab":"ISO","vocabURI":"tw"}},{"name":"Russie, f\u00e9d\u00e9ration de","abbreviation":"ru","extLink":{"vocab":"ISO","vocabURI":"ru"}},{"name":"Espagne","abbreviation":"es","extLink":{"vocab":"ISO","vocabURI":"es"}},{"name":"Royaume-Uni","abbreviation":"gb","extLink":{"vocab":"ISO","vocabURI":"gb"}},{"name":"Etats-Unis","abbreviation":"us","extLink":{"vocab":"ISO","vocabURI":"us"}}],"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\": \"Enfance (6 \u00e0 12 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Population g\u00e9n\u00e9rale\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \" enfant scolaris\u00e9 en primaire - \u00e2g\u00e9 entre 8 et 13 ans\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es paracliniques','Donn\u00e9es biologiques','Donn\u00e9es paracliniques (hors biologiques) : Anthropom\u00e9trie']","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"}]},"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 de population \u00e0 finalit\u00e9 statistique']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"MeasurementsAndTests.Physical\",\"vocab\":\"CESSDA\"},\"value\":\"Mesures physiques\/biologiques (tension art\u00e9rielle, poids, biochimie, imagerie...)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"Monde\/World : 721 601France : 7 432"},"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":"04-03-2014","lastUpdatedAuto":null,"lastUpdatedManual":"05-09-2017","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/erj.ersjournals.com\/content\/24\/3\/406.long"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Priv\u00e9 \u00e0 but non lucratif","Public (France)","Public (France)"],"otherFundingAgentType":["","","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":true},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":false,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Polluants mesur\u00e9s sous les pr\u00e9aux des \u00e9coles et recueilli les mesures effectu\u00e9es par les r\u00e9seaux urbains de surveillance de la qualit\u00e9 de l\u2019air :- SO2, FN, NOx, NO2, O3, et PM \u00e0 l'aide de mesures collectives (r\u00e9seaux de surveillance de ville) (macro-environnement) ;- NOx, NO2, O3, C.O.V. (formald\u00e9hyde) et PM \u00e0 l'aide de capteurs passifs dans les \u00e9coles (micro-environnement).;- NO2, O3, C.O.V. \u00e0 l'aide de badges individuelles dans le cadre du panel (individu).Chaque centre peut choisir le protocole qui lui convient le mieux. Cependant, un protocole minimum a \u00e9t\u00e9 d\u00e9cid\u00e9 au niveau europ\u00e9en.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"Cent cinquante-six centres dans 56 pays \/ Am\u00e9rique du Nord, Am\u00e9rique centrale, Am\u00e9rique du Sud, Europe de l\u2019Ouest, Europe centrale (lbanie, Allemagne, Estonie, Espagne, France, Gr\u00e8ce, Islande, Italie, Norv\u00e8ge, Pays-Bas, Portugal, Royaume-Uni, Su\u00e8de), Pays baltes, Extr\u00eame-Orient, Pacifique Ouest, Afrique anglophone, Afrique francophone, Asie duSud-Est, Pays m\u00e9diterran\u00e9ens de l\u2019Est et Oc\u00e9anie.En France (\u00e9coles primaires de six villes fran\u00e7aises : Cr\u00e9teil, Clermont-Ferrand, Bordeaux, Marseille, Reims, Strasbourg)."},"dataTypes":{"clinicalDataDetails":"Bilan d\u2019allergie : tests allergologiques cutan\u00e9s, examen standardis\u00e9 de la peau de Williams (ecz\u00e9ma), test de course libre avec d\u00e9bit de pointe respiratoire (hyperr\u00e9activit\u00e9 bronchique)","biologicalDataDetails":"urines et cheveux avec recherche de cotinine (m\u00e9tabolite de la nicotine), des marqueurs d\u2019inflammation et du plomb","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}