{"doc_desc":{"title":"Etude longitudinale chez les adultes de plus de 65 ans consultant en m\u00e9decine g\u00e9n\u00e9rale pour infection respiratoire aig\u00fce : \u00e9valuation du fardeau de la grippe","idno":"FRESH-PEF152-fr","producers":[{"name":"Christel LECLERC-ZWIRN","affiliation":"GLAXOSMITHKLINE (FRANCE)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF152-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"152"},{"agency":"FReSH","code":"FRESH-PEF152"}]},"title":"Etude longitudinale chez les adultes de plus de 65 ans consultant en m\u00e9decine g\u00e9n\u00e9rale pour infection respiratoire aig\u00fce : \u00e9valuation du fardeau de la grippe","alternate_title":"EFG Senior"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Christel;LECLERC-ZWIRN","firstname":"Christel","lastname":"LECLERC-ZWIRN","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00z1h3j87","role":"organisation id"},{"title":"SIREN","uri":"592052146","role":"organisation id"}],"email":"christel.c.leclerc-zwirn@gsk.com","affiliationName":"GLAXOSMITHKLINE (FRANCE)","PILabo":"Laboratoire GSK","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (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":"Christel;LECLERC-ZWIRN","lastname":"LECLERC-ZWIRN","firstname":"Christel","type":"contact","email":"christel.c.leclerc-zwirn@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":"sujets \u00e2g\u00e9s"},{"keyword":"\u00e9pid\u00e9miologie"}],"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":"Infectiologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/fa2ceeab-3b2f-45e9-9243-e5a8005b98de"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D055552"}]},{"topic":"","vocab":"cim-11","extLink":[{"uri":"100000000000000005366162204393472","title":"CIM-11"}]},{"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":"D\u00e9crire et comparer le fardeau des infections respiratoires aigu\u00ebs (IRA) li\u00e9es au virus de la grippe, en termes de morbidit\u00e9 et de consommation m\u00e9dicale, selon le statut vaccinal, chez les 65 ans et plus consultant spontan\u00e9ment en m\u00e9decine g\u00e9n\u00e9rale","abstract":"","coll_dates":[{"start":"2008-01-01","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\": \"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\": \"\u2022Patient de 65 ans et plus \u2022Patient pr\u00e9sentant une infection respiratoire aigu\u00eb d\u00e9finie comme un tableau clinique associant une apparition brutale de signes respiratoires (toux, rhinite, coryza) avec un contexte infectieux aigu (fi\u00e8vre, asth\u00e9nie, c\u00e9phal\u00e9e, myalgie\u2026), depuis moins de 48h.  \u2022Pour les patients de 80 ans et plus, les tableaux cliniques peuvent associer d\u2019autres signes g\u00e9n\u00e9raux (confusion mentale, d\u00e9shydratation, anorexie, troubles digestifs, malaise g\u00e9n\u00e9ral, courbatures, c\u00e9phal\u00e9es) et respiratoires (de la rhinite \u00e0 la pneumopathie)\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude','Donn\u00e9es biologiques']","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\nConsommation de soins\/services de sant\u00e9"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Base m\u00e9dico-administrative (de patients, Assurance Maladie\/Mutuelle) Registre de maladies, de d\u00e9c\u00e8s']"}},"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":"< 500 individus","response_rate":"93"},"method_notes":"Etude observationnelle","study_class":"Inconnu","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":"","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":"14-12-2010","lastUpdatedAuto":null,"lastUpdatedManual":"01-01-2020","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industrie"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Industrie"],"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":"Chaque investigateur devra inclure, durant toute la p\u00e9riode \u00e9pid\u00e9mique (\u00e9quivalente \u00e0 la p\u00e9riode d\u2019inclusion), les 7 premiers patients r\u00e9pondant aux crit\u00e8res d\u2019\u00e9ligibilit\u00e9. L\u2019investigateur informera les patients ayant accept\u00e9 l\u2019\u00e9tude, des objectifs de l\u2019\u00e9tude \u00e0 l\u2019aide de la notice d\u2019information et leur fera signer un consentement express. Il compl\u00e8tera ensuite le questionnaire m\u00e9decin d\u2019inclusion et remettra le carnet de suivi \u00e0 son patient en lui expliquant les modalit\u00e9s de remplissage de ce carnet. Il devra notifier par fax chaque inclusion au centre logistique. L\u2019investigateur r\u00e9alisera un pr\u00e9l\u00e8vement nasal et le transmettra au laboratoire de r\u00e9f\u00e9rence selon le protocole de pr\u00e9l\u00e8vement de l\u2019\u00e9tude. Afin de contr\u00f4ler un \u00e9ventuel biais de s\u00e9lection des patients, un registre de non inclusion sera mis en place. Il sera demand\u00e9 au m\u00e9decin investigateur de compl\u00e9ter ce registre, pour l\u2019ensemble des patients r\u00e9pondant aux crit\u00e8res d\u2019\u00e9ligibilit\u00e9 non inclus dans la cohorte et de renseigner le motif de non inclusion quel qu\u2019il soit.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"Pr\u00e9l\u00e8vement nasal","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}