{"doc_desc":{"title":"Observatoire national des Endocardites infectieuses","idno":"FRESH-PEF73415-fr","producers":[{"name":"Nadine JUGE","affiliation":"CENTRE HOSPITALIER REGIONAL ET UNIVERSITAIRE DE NANCY"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73415-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73415"},{"agency":"FReSH","code":"FRESH-PEF73415"}]},"title":"Observatoire national des Endocardites infectieuses","alternate_title":"OBSERVATOIRE EI"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CESREES"},{"name":"Autre"}]},"authoring_entity":[{"type":"investigator","name":"Christine;SELTON-SUTY","PILabo":"CHRU DE NANCY \/ Cardiologie M\u00e9dicale","affiliationName":"CENTRE HOSPITALIER REGIONAL ET UNIVERSITAIRE DE NANCY","extlink":[{"title":"ORCID","uri":"0000-0003-4129-5784","role":"pi id"},{"title":"IdRef","uri":"128186194","role":"pi id"},{"title":"SIREN","uri":"200042166","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"c.suty-selton@chru-nancy.fr","isContact":"Oui"}],"oth_id":[{"name":"EURO-ENDO (European Infective Endocarditis Registry)","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CENTRE HOSPITALIER REGIONAL ET UNIVERSITAIRE DE NANCY","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/016ncsr12","role":"sponsor id"},{"title":"SIREN","uri":"200042166","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"AEPEI (ASSOCIATION POUR L'ETUDE ET LA PREVENTION DES L'ENDOCARDITE INFECTIEUSE)","extlink":[{"title":"SIREN","uri":"428445696"}]}]},"distribution_statement":{"contact":[{"name":"Nelly;AGRINIER","email":"n.agrinier@chru-nancy.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER REGIONAL ET UNIVERSITAIRE DE NANCY","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/016ncsr12","role":"organisation id","title":"ROR"},{"uri":"200042166","role":"organisation id","title":"SIREN"}]},{"name":"Christine;SELTON-SUTY","email":"c.suty-selton@chru-nancy.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER REGIONAL ET UNIVERSITAIRE DE NANCY","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/016ncsr12","role":"organisation id","title":"ROR"},{"uri":"200042166","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"endocardite infectieuse"}],"topics":[{"topic":"Cardiologie et m\u00e9decine vasculaire","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/4455c187-2f2f-4cd1-a4dd-449f59d73b39"},{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/c42fc6ec-b216-4a24-9e9d-f5e781c175a0"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D002309"}]},{"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":"Endocardite aig\u00fce ou subaig\u00fce","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/162683166","title":"CIM-11"}]},{"topic":"Maladies des valves cardiaques","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1121431779","title":"CIM-11"}]},{"topic":"D\u00e9terminants comportementaux : Addictions","vocab":"health determinant"},{"topic":"Autre","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"}],"purpose":"constituer une base nationale des endocardites infectieuses, renseign\u00e9e par l\u2019ensemble des centres volontaires, \u00e0 partir d\u2019un cahier d\u2019observation standardis\u00e9. Un tel observatoire permettra de d\u00e9crire le profil clinique, microbiologique, th\u00e9rapeutique et \u00e9volutif de l\u2019EI ; d\u2019analyser les facteurs de risques de la maladie et ses facteurs pronostics d\u2019\u00e9volution ; de d\u00e9crire les pratiques de prise en charge ; d\u2019\u00e9valuer et de comparer en situation r\u00e9elle les strat\u00e9gies th\u00e9rapeutiques m\u00e9dicamenteuses (notamment antibioth\u00e9rapie) et chirurgicale. L\u2019objectif principal de cet observatoire est de constituer une base nationale des endocardites infectieuses, renseign\u00e9e par l\u2019ensemble des centres volontaires, \u00e0 partir d\u2019un cahier d\u2019observation standardis\u00e9.","abstract":"","coll_dates":[{"start":"1991-01-01"}],"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 (19 \u00e0 24 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\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\": \"Crit\u00e8res d\u2019inclusion :  \u2022Patient majeur \u2022Pris en charge dans un des centres participants \u2022L\u2019application des crit\u00e8res de classification diagnostique de la Duke modifi\u00e9e par Li [9] est faite apr\u00e8s recueil de l\u2019ensemble des donn\u00e9es \u00e0 la sortie du patient. Ne seront inclus dans l\u2019observatoire que les patients r\u00e9pondant aux crit\u00e8res d\u2019endocardite certaine ou possible. \u2022Affili\u00e9 \u00e0 un r\u00e9gime fran\u00e7ais de s\u00e9curit\u00e9 sociale \",\n    \"clusion_E\": \"\u2022L\u2019opposition \u00e0 la participation \u00e0 l\u2019observatoire\"\n}","data_kind":"['Donn\u00e9es cliniques','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\nEv\u00e9nements de sant\u00e9\/mortalit\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":"['Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}"],"research_instrument":"","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"4000"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"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":"----","lastUpdatedAuto":null,"lastUpdatedManual":"01-10-2021","isContributorPI":"Non","contributorName":"Nadine JUGE","contributorAffiliation":"CENTRE HOSPITALIER REGIONAL ET UNIVERSITAIRE DE NANCY","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["","",""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Priv\u00e9 \u00e0 but non lucratif"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":"Oui"},"collaborations":{"networkConsortium":"Oui"},"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":"recueil par le m\u00e9decin d\u00e9clarant \u00e0 partir du dossier m\u00e9dical (cardiologue, infectiologue)","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"site de l'endocardite, ant\u00e9c\u00e9dents, symptomatologie de l'endocardite, complications","biologicalDataDetails":"donn\u00e9es microbiologiques","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}