{"doc_desc":{"title":"Cohorte de patients atteints de bronchopneumopathie chronique obstructive","idno":"FRESH-PEF73257-fr","producers":[{"name":"St\u00e9phane SCHUCK","affiliation":"KAPPA SANTE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73257-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73257"},{"agency":"FReSH","code":"FRESH-PEF73257"}]},"title":"Cohorte de patients atteints de bronchopneumopathie chronique obstructive","alternate_title":"EXACO"},"study_authorization":{"agency":[{"name":"CNIL"}]},"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":"Oui"},{"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":"Oui"},{"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":"Oui"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (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":"BPCO"},{"keyword":"bronchite"},{"keyword":"exacerbation"},{"keyword":"cohorte"}],"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":"Bronchopneumopathie chronique obstructive","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/133207228","title":"CIM-11"}]},{"topic":"Autre","vocab":"health determinant"}],"purpose":"Les objectifs principaux de l'\u00e9tude sont de D\u00e9crire qualitativement et quantitativement les exacerbations d'une cohorte de patients atteints de BPCO en fonction du stade de s\u00e9v\u00e9rit\u00e9 et v\u00e9rifier l'hypoth\u00e8se de la pr\u00e9sence d'un sous-groupe de patients \u00ab exacerbateurs fr\u00e9quents \u00bb pr\u00e9sentant un nombre d'exacerbations homog\u00e8ne dans le temps. Le cas \u00e9ch\u00e9ant, d\u00e9terminer la valeur seuil (nombre d'exacerbations) qui caract\u00e9rise un exacerbateur fr\u00e9quent en formulant l'hypoth\u00e8se que 3 exacerbations par an, quelle que soit leur s\u00e9v\u00e9rit\u00e9, sont suffisantes pour \u00eatre class\u00e9 \u00ab exacerbateur fr\u00e9quent \u00bb. De plus, plusieurs objectifs secondaires seront poursuivis Identifier des facteurs associ\u00e9s \u00e0 ce profil \u00ab exacerbateur fr\u00e9quent \u00bb. Identifier des crit\u00e8res plus volontiers associ\u00e9s \u00e0 la s\u00e9v\u00e9rit\u00e9 de l'exacerbation. Confirmer l'association exacerbateur fr\u00e9quent\/d\u00e9clin acc\u00e9l\u00e9r\u00e9 de la fonction respiratoire. Valider l'\u00e9chelle VSRQ sur les crit\u00e8res m\u00e9trologiques suivants : reproductibilit\u00e9, validit\u00e9 clinique par comparaison avec le questionnaire de St George, unidimensionnalit\u00e9 du VSRQ, coh\u00e9rence interne du VSRQ, sensibilit\u00e9 au changement, diff\u00e9rence minimale importante.","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":"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    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Les pneumologues (lib\u00e9raux ou exer\u00e7ant en milieu hospitalier : CHG, CHU) incluront les patients \u00e2g\u00e9s de plus de 40 ans, atteints de BPCO de stade II ou III selon les crit\u00e8res de la SPLF (2003), fumeurs ou ex-fumeurs (> 15 paquets-ann\u00e9es), en \u00e9tat stable, dont le VEMS apr\u00e8s bronchodilatateur est inf\u00e9rieur ou \u00e9gal \u00e0 80 % de la valeur th\u00e9orique et le rapport VEMS\\\/CV \u226a 70 %. Les patients devront accepter de compl\u00e9ter \u00e0 chaque exacerbation et mensuellement le carnet d'autosurveillance et d'\u00eatre contact\u00e9 par t\u00e9l\u00e9phone tous les trimestres durant 4 ans. Ils signeront un formulaire de consentement.  Ne pourront \u00eatre inclus les patients pr\u00e9sentant une tuberculose active, un cancer (ou ayant re\u00e7u un traitement anti-canc\u00e9reux au cours des 3 ann\u00e9es pr\u00e9c\u00e9dentes), des bronchectasies diffuses, une mucoviscidose, un asthme (sur les donn\u00e9es de l'histoire clinique), ou toute autre pathologie pulmonaire diagnostiqu\u00e9e (sarco\u00efdose, fibrose pulmonaire, pneumoconiose...). \",\n    \"clusion_E\": \"seront l'existence d'une exacerbation dans le mois pr\u00e9c\u00e9dant l'inclusion, l'absence de t\u00e9l\u00e9phone, la participation \u00e0 une autre \u00e9tude clinique ou \u00e9pid\u00e9miologique\"\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":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nQualit\u00e9 de vie\/sant\u00e9 per\u00e7ue"}]},"method":{"data_collection":{"time_method":"","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\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"835"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Cohorte"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"A d\u00e9finir\",\"extLink\":[]}"},"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":"29-10-2015","lastUpdatedAuto":null,"lastUpdatedManual":"01-01-2020","isContributorPI":"Non","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":["Industrie","Industrie","Industrie","Industrie","Industrie"],"otherFundingAgentType":["","","","",""]},"sponsor":{"sponsorType":["Priv\u00e9 \u00e0 but non lucratif"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Oui","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Receuil par des pneumologues hospitaliers et\/ou lib\u00e9raux","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"les caract\u00e9ristiques socio-d\u00e9mographiques, le profil clinique et les traitements en cours, les \u00e9chelles de dyspn\u00e9e (MRC\/Score de Borg), l'exploration Fonctionnelle Respiratoire (EFR), le test de marche de 6 minutes (TM6), l'impact sur la vie quotidienne, la qualit\u00e9 de vie (autoquestionnaire VSRQ). . Les examens facultatifs sont : la saturation art\u00e9rielle en oxyg\u00e8ne, l'examen cytobact\u00e9riologique des crachats (ECBC), la notion d'emphys\u00e8me en tomodensitom\u00e9trie TDM), la mesure des gaz du sang. L'indice de masse corporelle, la dyspn\u00e9e mesur\u00e9e par l'\u00e9chelle MRC et du test de marche de 6 minutes. Lors de chaque visite de suivi, la survenue d'\u00e9pisodes d'exacerbations ainsi que toutes les modifications intervenues depuis la visite pr\u00e9c\u00e9dente seront notifi\u00e9es","biologicalDataDetails":"","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}