{"doc_desc":{"title":"Cohort of Patients with Chronic Obstructive Pulmonary Disease","idno":"FRESH-PEF73257-en","producers":[{"name":"St\u00e9phane SCHUCK","affiliation":"KAPPA SANTE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73257-en","IDno":{"metadata_no":[{"agency":"PEF","code":"73257"},{"agency":"FReSH","code":"FRESH-PEF73257"}]},"title":"Cohort of Patients with Chronic Obstructive Pulmonary Disease","alternate_title":"EXACO"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Fr\u00e9d\u00e9ric;MASURE","PILabo":"Saint Remi Medical Group","affiliationName":"CAB GASTROENTEROLOGIE PUCHELLE CARTERET","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"","uri":"","role":"pi id"},{"title":"SIREN","uri":"347921793","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"fredmasure@gmail.com","isContact":"Yes"},{"type":"investigator","name":"Alexis;CORTOT","PILabo":"Lille Regional University Hospital","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE (CHU)","extlink":[{"title":"ORCID","uri":"0000-0003-0098-2238","role":"pi id"},{"title":"IdRef","uri":"110084632","role":"pi id"},{"title":"SIREN","uri":"265906719","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"alexis.cortot@chru-lille.fr","isContact":"Yes"},{"type":"investigator","name":"St\u00e9phane;SCHUCK","PILabo":"Kappa Sant\u00e9","affiliationName":"KAPPA SANTE","extlink":[{"title":"ORCID","uri":"0000-0003-2642-7726","role":"pi id"},{"title":"IdRef","uri":"248665758","role":"pi id"},{"title":"SIREN","uri":"445405046","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"stephane.schuck@kappasante.com","isContact":"Yes"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"SOCIETE DE PNEUMOLOGIE DE LANGUE FRANCAISE","extlink":[{"title":"SIREN","uri":"310133608","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"ALTANA PHARMA AG","extlink":[{"title":"SIREN","uri":"422716779"}]},{"name":"ASTRAZENECA (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/016qv5070"},{"title":"SIREN","uri":"558201075"}]},{"name":"BOEHRINGER INGELHEIM INTERNATIONAL GMBH","extlink":[{"title":"SIREN","uri":"508241882"}]},{"name":"GLAXOSMITHKLINE (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00z1h3j87"},{"title":"SIREN","uri":"592052146"}]},{"name":"PFIZER (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02c9yny10"},{"title":"SIREN","uri":"433623550"}]}]},"distribution_statement":{"contact":[{"name":"Fr\u00e9d\u00e9ric;MASURE","email":"fredmasure@gmail.com","type":"contact","affiliationName":"CAB GASTROENTEROLOGIE PUCHELLE CARTERET","contactPointLabo":"","extlink":[{"uri":"347921793","role":"organisation id","title":"SIREN"}]},{"name":"Alexis;CORTOT","email":"alexis.cortot@chru-lille.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE (CHU)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02ppyfa04","role":"organisation id","title":"ROR"},{"uri":"265906719","role":"organisation id","title":"SIREN"}]},{"name":"St\u00e9phane;SCHUCK","email":"stephane.schuck@kappasante.com","type":"contact","affiliationName":"KAPPA SANTE","contactPointLabo":"","extlink":[{"uri":"445405046","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"bronchitis"},{"keyword":"COPD"},{"keyword":"exacerbation"},{"keyword":"cohort"}],"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":"Chronic obstructive pulmonary disease","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/133207228","title":"CIM-11"}]}],"purpose":"The main aims of the study are to qualitatively and quantitatively describe the exacerbations in a cohort of COPD patients at different levels of severity and to confirm the existence of a sub-group of patients defined as frequent exacerbators who experience a high number of exacerbations over time. Where applicable, to determine the threshold value (number of exacerbations) that distinguishes frequent exacerbations by assuming that 3 exacerbations per year, regardless of severity, are sufficient to class the patient as a \u201cfrequent\u201d exacerbator. Several secondary aims will also be pursued. To identify factors associated with frequent exacerbators. To identify criteria more readily associated with exacerbation severity. To confirm the link between frequent exacerbators\/accelerated decline in lung function. A validation of the VSRQ scale will be performed with the following metrics: replication; clinical validity through comparison with the St. George questionnaire; VSRQ unidimensional structure; VSRQ internal consistency; sensitivity to change; minimal important distance.","abstract":"","coll_dates":[{"start":"2006-01-01","end":"2010-01-01"}],"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    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Respiratory physicians (private practice or hospital: CHG, CHU) will enrol patients aged 40 and over with stage II or III COPD according to SPLF criteria (2003); smokers or ex-smokers (>15 pack-years); stable and with post-bronchodilator FEV1 lower than or equal to 80% of predicted value and FEV1\\\/VC relationship <70%. Patients must accept and complete the self-monitoring log on a monthly basis and, at each exacerbation, can be contacted by phone every three months for 4 years. Participants shall sign a consent form.  The following may not be included: patients with active tuberculosis, cancer (or who received cancer treatment in the last 3 years), diffuse bronchiectasis, cystic fibrosis, asthma (in clinical history), or any other diagnosed lung diseases (sarcoidosis, pulmonary fibrosis, pneumoconiosis, etc.). Other \",\n    \"clusion_E\": \"Exclusion criteria include exacerbation one month prior to enrolment; absence of a telephone and participation in another clinical or epidemiological study.\"\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\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\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[1000-10000[ individuals","response_rate":"835"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Cohort study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"To be defined\",\"extLink\":[]}"},"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":"29-10-2015","lastUpdatedAuto":null,"lastUpdatedManual":"01-01-2020","isContributorPI":"No","contributorName":"St\u00e9phane SCHUCK","contributorAffiliation":"KAPPA SANTE","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.em-consulte.com\/rmr\/article\/134729"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industry","Industry","Industry","Industry","Industry"],"otherFundingAgentType":["","","","",""]},"sponsor":{"sponsorType":["Private non-profit"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Collected by hospital and\/or private respiratory physicians.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"Socio-demographic characteristics; clinical profile and ongoing treatment; breathlessness scales (MRC\/Borg Score), Pulmonary Function testing (PFT); 6-minute walking test (TM6); impact on daily life; quality of life (VSRQ self-administered questionnaire). Optional tests are: blood oxygen saturation; sputum cytology examination (SCE); signs of emphysema on computed tomography (CT); measurement of blood gas levels. Body Mass Index; breathlessness measured with MRC scale and 6-minute walking test. During each follow-up visit; onset of exacerbation episodes as well as any changes occurring since the last visit will be made known.","biologicalDataDetails":"","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}