{"study_desc":{"title_statement":{"idno":"FRESH-PEF73245-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73245"},{"agency":"FReSH","code":"FRESH-PEF73245"}]},"title":"Etude transversale sur des patients atteints de bronchopneumopathie chronique obstructive : \u00e9valuation en vie r\u00e9elle de la manipulation des syst\u00e8mes d\u2019inhalation","alternate_title":"INHALER"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CESREES"}]},"authoring_entity":[{"name":"Pierre-Olivier;GIRODET","firstname":"Pierre-Olivier","lastname":"GIRODET","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/057qpr032","role":"organisation id"},{"title":"SIREN","uri":"130018351","role":"organisation id"},{"uri":"0000-0002-9298-9711","role":"pi id","title":"ORCID"},{"uri":"060795255","role":"pi id","title":"IdRef"}],"email":"pierre-olivier.girodet@u-bordeaux.fr","affiliationName":"UNIVERSITE DE BORDEAUX","PILabo":"Universit\u00e9 de Bordeaux \/ Universit\u00e9 de Bordeaux - 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d\u2019inhalation"},{"keyword":"Bordeaux Pharmaco\u00e9pi"},{"keyword":"\u00e9tude transversale"},{"keyword":"service de pharmacologie m\u00e9dicale"}],"topics":[{"topic":"Pneumologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/f6e18c52-6087-4662-904c-5c4b8174e40e"},{"title":"MeSH","uri":"D015272"}]},{"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":"L'objectif principal est d'\u00e9valuer en vie r\u00e9elle la manipulation des inhalateurs utilis\u00e9s par des patients atteints de Bronchopneumopathie obstructive 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sup\u00e9rieur \u00e0 40 ans Tabagisme sup\u00e9rieur \u00e0 10 paquets-ann\u00e9e Utilisation par le patient, depuis au moins 1 mois, d'un syst\u00e8me d\u2019inhalation \u00e0 l'\u00e9tude  \",\"clusion_E\":\"Grossesse\"}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es de sant\u00e9 rapport\u00e9es par les participants 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\r\nQualit\u00e9 de vie\/sant\u00e9 per\u00e7ue"}]},"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":"['Via les professionnels de sant\u00e9 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":"5000"},"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\"}]}","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."},"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":""}}},"additional":{"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"Import\u00e9e","creationDate":"08-10-2015","lastUpdatedManual":"27-10-2017","isContributorPI":"","contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industrie"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public 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