{"doc_desc":{"title":"Etude longitudinale sur des patients asthmatiques trait\u00e9s par cortico\u00efdes inhal\u00e9s","idno":"FRESH-PEF165-fr","producers":[{"name":"C\u00e9line PRIBIL","affiliation":"GLAXOSMITHKLINE (FRANCE)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF165-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"165"},{"agency":"FReSH","code":"FRESH-PEF165"}]},"title":"Etude longitudinale sur des patients asthmatiques trait\u00e9s par cortico\u00efdes inhal\u00e9s","alternate_title":"OCSIGEN"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"C\u00e9line;PRIBIL","firstname":"C\u00e9line","lastname":"PRIBIL","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00z1h3j87","role":"organisation id"},{"title":"SIREN","uri":"592052146","role":"organisation id"}],"email":"celine.c.pribil@gsk.com","affiliationName":"GLAXOSMITHKLINE (FRANCE)","PILabo":"Laboratoire GSK","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"GLAXOSMITHKLINE (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00z1h3j87","role":"sponsor id"},{"title":"SIREN","uri":"592052146","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"GLAXOSMITHKLINE (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00z1h3j87"},{"title":"SIREN","uri":"592052146"}]}]},"distribution_statement":{"contact":[{"name":"C\u00e9line;PRIBIL","lastname":"PRIBIL","firstname":"C\u00e9line","type":"contact","email":"celine.c.pribil@gsk.com","affiliationName":"GLAXOSMITHKLINE (FRANCE)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00z1h3j87","role":"organisation id","title":"ROR"},{"uri":"592052146","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"cohorte"},{"keyword":"cortico\u00efdes inhal\u00e9s"}],"topics":[{"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":"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 conditions d\u2019utilisation de la fluticasone et des autres cortico\u00efdes inhal\u00e9s en situation pragmatique de m\u00e9decine de ville et en m\u00e9decine sp\u00e9cialis\u00e9e pneumologique de ville, \u00e9valuer la s\u00e9v\u00e9rit\u00e9 de l\u2019asthme des patients pris en charge et mesurer l\u2019ad\u00e9quation de la prise en charge avec les recommandations nationales","abstract":"","coll_dates":[{"start":"2004-01-01","end":"2009-01-01"}],"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\": \"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\": \"Volet MG : La population \u00e9ligible est d\u00e9finie par tous les patients asthmatiques de plus de 15 ans qui ont consult\u00e9 au moins 2 fois l\u2019ann\u00e9e pr\u00e9c\u00e9dente et chez qui une corticoth\u00e9rapie inhal\u00e9e est en cours (au moins une prescription sur les six derniers mois). Seront inclus les patient ainsi d\u00e9finis venant consulter spontan\u00e9ment pour asthme pendant la p\u00e9riode d\u2019inclusion.  \",\n    \"clusion_E\": \"Le refus de participer et l\u2019association de l\u2019asthme avec une BPCO sont des crit\u00e8res de non inclusion Volet pneumo : Personnes asthmatiques prises en charge en pneumologie lib\u00e9rale pr\u00e9sentes dans la patient\u00e8le des investigateurs de l\u2019\u00e9tude et r\u00e9pondant aux crit\u00e8res d\u2019inclusion\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Consommation de soins\/services de sant\u00e9"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Probability.Stratified\",\"vocab\":\"CESSDA\"},\"value\":\"Probabiliste : stratifi\u00e9\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via les professionnels d'exercice lib\u00e9ral']"}},"coll_mode":["{\"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":"1691"},"method_notes":"Etude observationnelle","study_class":"Inconnu","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":"","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":"14-12-2010","lastUpdatedAuto":null,"lastUpdatedManual":"01-01-2019","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"Liste des publications dans Pubmed","link":"http:\/\/tinyurl.com\/pubmed-ocsigen"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industrie"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Industrie"],"otherSponsorType":[""]},"governance":{"committee":""},"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":"Volet MG :Les caract\u00e9ristiques des patients seront recueillies au sein des donn\u00e9es historiques pr\u00e9sentes dans la base Thal\u00e8s, puis \u00e0 la visite d\u2019inclusion et lors de toutes les visites survenant pendant la p\u00e9riode de suivi. A chaque visite, le stade de s\u00e9v\u00e9rit\u00e9 des patients selon la classifications GINA clinique et th\u00e9rapeutique sera \u00e9valu\u00e9Pendant la p\u00e9riode d\u2019inclusion, \u00e0 chaque consultation d\u2019un patient \u00e9ligible, l\u2019\u00e9tude lui sera propos\u00e9e. Le cas \u00e9ch\u00e9ant, le questionnaire informatique d\u2019inclusion est rempli et le patient est inclus dans la cohorte. A chaque consultation effectu\u00e9e pendant la p\u00e9riode de suivi, un \u00e9cran \u00ab pop-up \u00bb contenant le questionnaire de suivi appara\u00eetra sur l\u2019ordinateur de l\u2019investigateur.Volet pneumo :Les conditions d\u2019utilisation des cortico\u00efdes inhal\u00e9s selon les stades de s\u00e9v\u00e9rit\u00e9 seront d\u00e9crites au moyen de trois questionnaires : un questionnaire historique (donn\u00e9es issues du dossier m\u00e9dical du patient), un questionnaire d\u2019inclusion et un questionnaire de suivi qui seront impl\u00e9ment\u00e9s sous forme informatique. Un quatri\u00e8me questionnaire, auto administr\u00e9 relatif au contr\u00f4le de l\u2019asthme sera compl\u00e9t\u00e9 par le patient \u00e0 l\u2019inclusion et lors de chaque visite durant le suivi. Le recueil des donn\u00e9es sera r\u00e9alis\u00e9 sur support informatique via un site Internet s\u00e9curis\u00e9 d\u00e9di\u00e9 \u00e0 l\u2019\u00e9tude. Le m\u00e9decin rentrera directement les informations souhait\u00e9es dans des formulaires en ligne","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":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}