{"doc_desc":{"title":"Etude transversale sur des patients atteints de bronchopneumopathie chronique obstructive : \u00e9valuation en vie r\u00e9elle de la manipulation des syst\u00e8mes d\u2019inhalation","idno":"FRESH-PEF73245-fr","producers":[{"name":"C\u00e9cile DROZ-PERROTEAU","affiliation":"UNIVERSITE DE BORDEAUX"}]},"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 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BORDEAUX","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/057qpr032","role":"sponsor id"},{"title":"SIREN","uri":"130018351","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"NOVARTIS PHARMA SAS","extlink":[{"title":"SIREN","uri":"410349070"}]}]},"distribution_statement":{"contact":[{"name":"Pierre-Olivier;GIRODET","lastname":"GIRODET","firstname":"Pierre-Olivier","type":"contact","email":"pierre-olivier.girodet@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":"Bronchopneumopathie chronique obstructive"},{"keyword":"manipulation des syst\u00e8mes 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":"http:\/\/id.nlm.nih.gov\/mesh\/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 (BPCO).","abstract":"","coll_dates":[{"start":"2015-01-01","end":"2015-12-31"}],"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\": \"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\": \"Diagnostic de BPCO Age 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  \",\n    \"clusion_E\": \"Grossesse\"\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\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 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\"}]}"},"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":"08-10-2015","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":""},"collaborations":{"networkConsortium":""},"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":"Les donn\u00e9es de l'\u00e9tude sont recueillies \u00e0 travers des questionnaires papier standardis\u00e9s compl\u00e9t\u00e9s par les m\u00e9decins participants. 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 g\u00e9n\u00e9ralistes et pneumologues ayant une activit\u00e9 lib\u00e9rale en France"},"dataTypes":{"clinicalDataDetails":"Caract\u00e9ristiques g\u00e9n\u00e9rales du patient (sexe, \u00e2ge et comorbidit\u00e9s) - Histoire de la BPCO","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"}