{"doc_desc":{"title":"Follow-up cohort of patients with chronic obstructive pulmonary disease treated by Seretide Diskus 500 \u00b5g \/ 50 doses \u00ae","idno":"FRESH-PEF164-en","producers":[{"name":"C\u00e9line PRIBIL","affiliation":"GLAXOSMITHKLINE (FRANCE)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF164-en","IDno":{"metadata_no":[{"agency":"PEF","code":"164"},{"agency":"FReSH","code":"FRESH-PEF164"}]},"title":"Follow-up cohort of patients with chronic obstructive pulmonary disease treated by Seretide Diskus 500 \u00b5g \/ 50 doses \u00ae","alternate_title":"USB"},"study_authorization":{"agency":[]},"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":"Epidemiology France Portal (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":"cohort"},{"keyword":"Seretide Diskus"}],"topics":[{"topic":"Pulmonary medicine","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":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"Describe the population pursuing SERETIDE Diskus 500 \u00b5g \/ 50 doses within the framework of treating OCPD, the methods for prescribing it and their actual conditions of use (observance in particular) as well as the clinical change in patients. Evaluate the impact of the fixed-dose combinations on objective morbidity and on perceived morbidity of OCPD.","abstract":"","coll_dates":[{"start":"2007-01-01","end":"2011-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\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\": \"Adult (25 to 44 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Middle Aged (45 to 64 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Aged (65 to 79 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Aged, 80 and over (80 years and more)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"\u2022 Patient in whom a treatment via Seretide\u00ae Diskus 50 \u00b5g \\\/ 50 doses is initiated on the day of inclusion \u2022 Patients over the age of 40 years, \u2022 Smokers or ex-smokers (> 15 pack-years)\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth care consumption and services\r\nQuality of life\/health perception"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through independent healthcare practitioners']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Self-administered questionnaire\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[500-1000[ individuals","response_rate":"767"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"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":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"14-12-2010","lastUpdatedAuto":null,"lastUpdatedManual":"06-04-2012","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[{"type":"","title":"Liste des publications dans Pubmed","link":"http:\/\/tinyurl.com\/Pubmed-USB"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industry"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Industry"],"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":"\u2022 A doctor characteristics sheet completed at the location of the center\u2022 A non-inclusion registry of the patients treated for OPCD that consult during the inclusion period \u2022 An inclusion questionnaire completed by the doctor on D0 \u2022 A follow-up questionnaire completed by the doctor at each naturalistic follow-up visit throughout the entire duration of the study\u2022 A self-questionnaire completed by the patient at the inclusion visit \u2022 A self questionnaire completed by the patient at each naturalistic follow-up visit throughout the entire duration of the study\u2022 A questionnaire on the latest news for patients who left the study during 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