{"doc_desc":{"title":"Evaluation d'Oralair\u00ae en conditions r\u00e9elles d'utilisation","idno":"FRESH-PEF73297-fr","producers":[{"name":"C\u00e9cile DROZ-PERROTEAU","affiliation":"UNIVERSITE DE BORDEAUX"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73297-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73297"},{"agency":"FReSH","code":"FRESH-PEF73297"}]},"title":"Evaluation d'Oralair\u00ae en conditions r\u00e9elles d'utilisation","alternate_title":"EVORA"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CESREES"}]},"authoring_entity":[{"name":"Patrick;BLIN","firstname":"Patrick","lastname":"BLIN","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/057qpr032","role":"organisation id"},{"title":"SIREN","uri":"130018351","role":"organisation id"}],"email":"patrick.blin@u-bordeaux.fr","affiliationName":"UNIVERSITE DE BORDEAUX","PILabo":"Universit\u00e9 de Bordeaux \/ Universite de Bordeaux - Plateforme Bordeaux PharmacoEpi - Service de pharmacologie m\u00e9dicale - CIC Bordeaux CIC1401","isContact":true},{"name":"Mathieu;MOLIMARD","firstname":"Mathieu","lastname":"MOLIMARD","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/057qpr032","role":"organisation id"},{"title":"SIREN","uri":"130018351","role":"organisation id"}],"email":"mathieu.molimard@u-bordeaux.fr","affiliationName":"UNIVERSITE DE BORDEAUX","PILabo":"Universit\u00e9 de Bordeaux \/ Universite de Bordeaux - Plateforme Bordeaux PharmacoEpi - Service de pharmacologie m\u00e9dicale - CIC Bordeaux CIC1401","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"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":"STALLERGENES GREER (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00bbe8x87"},{"title":"SIREN","uri":"808540371"}]}]},"distribution_statement":{"contact":[{"name":"Patrick;BLIN","lastname":"BLIN","firstname":"Patrick","type":"contact","email":"patrick.blin@u-bordeaux.fr","affiliationName":"UNIVERSITE DE BORDEAUX","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/057qpr032","role":"organisation id","title":"ROR"},{"uri":"130018351","role":"organisation id","title":"SIREN"}]},{"name":"Mathieu;MOLIMARD","lastname":"MOLIMARD","firstname":"Mathieu","type":"contact","email":"mathieu.molimard@u-bordeaux.fr","affiliationName":"UNIVERSITE DE BORDEAUX","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/057qpr032","role":"organisation id","title":"ROR"},{"uri":"130018351","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Plateforme Bordeaux PharmacoEpi"},{"keyword":"Oralair"},{"keyword":"Pollens de gramin\u00e9es"},{"keyword":"Service de pharmacologie m\u00e9dicale"},{"keyword":"Adultes et enfants"},{"keyword":"Cohorte prospective"},{"keyword":"Rhinite allergique avec ou sans conjonctivite"}],"topics":[{"topic":"M\u00e9decine g\u00e9n\u00e9rale","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/4b9f8efb-68dd-45a1-b04c-d23d457d6898"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D058006"}]},{"topic":"Oto-rhino-laryngologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/9c3a57c5-68bd-4ee7-a9cc-aa8ba07bde94"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D010036"}]},{"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":"Pneumologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/f6e18c52-6087-4662-904c-5c4b8174e40e"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D015272"}]},{"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":"Maladies de l'appareil respiratoire","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/197934298","title":"CIM-11"}]},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"D\u00e9crire les modalit\u00e9s de prescription d\u2019Oralair\u00ae : indication, posologie, date d\u2019instauration du traitement par rapport \u00e0 la saison pollinique, traitements concomitants, notamment antihistaminiques, cortico\u00efdes locaux, cromones et d\u00e9congestionnants.","abstract":"","coll_dates":[{"start":"2014-01-01","end":"2015-01-01"}],"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\": \"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\": \"Patient initiant un traitement par Oralair\u00ae pour la prochaine saison pollinique,  Patient non trait\u00e9 ant\u00e9rieurement par Oralair\u00ae.  \",\n    \"clusion_E\": \"Refus de participation,  Patient de passage ou d\u00e9m\u00e9nagement pr\u00e9vu durant la p\u00e9riode d\u2019\u00e9tude,  Patient pr\u00e9sentant une barri\u00e8re linguistique (impossibilit\u00e9 de lire la lettre d\u2019information ou de compl\u00e9ter les auto-questionnaires) Patient participant \u00e0 un essai th\u00e9rapeutique \"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es biologiques','Donn\u00e9es socio-d\u00e9mographiques']","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":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Base administrative (d'employ\u00e9s, d'\u00e9l\u00e8ves, d'\u00e9tudiants, etc\u2026)']"}},"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":"[500-1000[ individus","response_rate":"525 patients (311 adultes et 214 enfants)"},"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":"Les modalit\u00e9s d'acc\u00e8s \u00e0 la base de donn\u00e9es doivent se faire par une requ\u00eate aupr\u00e8s du conseil scientifique de l'\u00e9tude.","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":"La propri\u00e9t\u00e9 et l'acc\u00e8s aux donn\u00e9es de l'\u00e9tude ont fait l'objet d'une convention entre l'Universit\u00e9 de Bordeaux et le laboratoire."}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"22-12-2015","lastUpdatedAuto":null,"lastUpdatedManual":"27-10-2017","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industrie"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":true},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":true,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Les donn\u00e9es de l'\u00e9tude sont recueillies par le biais de questionnaires papier standardis\u00e9s compl\u00e9t\u00e9s par les m\u00e9decins participants et d'auto-questionnaires standardis\u00e9s compl\u00e9t\u00e9s par les patients. Les donn\u00e9es sont ensuite saisies dans une base de donn\u00e9es sp\u00e9cifique de l'\u00e9tude","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"M\u00e9decins lib\u00e9raux, hospitaliers ou mixtes ayant une activit\u00e9 en allergologie en France"},"dataTypes":{"clinicalDataDetails":"Caract\u00e9ristiques g\u00e9n\u00e9rales du patient (sexe, \u00e2ge, comorbidit\u00e9s, traitements) - R\u00e9sultats de dosages\/tests et symptomatologie de la rhinite allergique","biologicalDataDetails":"R\u00e9sultats de dosage des IgE sp\u00e9cifiques aux pollens de gramin\u00e9es","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}