{"doc_desc":{"title":"Etude descriptive et pronostique des arboviroses end\u00e9miques et \u00e9mergentes dans les d\u00e9partements et r\u00e9gions d\u2019outre-mer et en France m\u00e9tropolitaine men\u00e9e dans une cohorte hospitali\u00e8re d\u2019enfants et d\u2019adultes suspects d\u2019arbovirose aigu\u00eb","idno":"FRESH-PEF73337-fr","producers":[{"name":"Andr\u00e9 CABIE","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE LA MARTINIQUE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73337-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73337"},{"agency":"FReSH","code":"FRESH-PEF73337"}]},"title":"Etude descriptive et pronostique des arboviroses end\u00e9miques et \u00e9mergentes dans les d\u00e9partements et r\u00e9gions d\u2019outre-mer et en France m\u00e9tropolitaine men\u00e9e dans une cohorte hospitali\u00e8re d\u2019enfants et d\u2019adultes suspects d\u2019arbovirose aigu\u00eb","alternate_title":"CARBO"},"study_authorization":{"agency":[{"name":"CPP"}]},"authoring_entity":[{"name":"Andr\u00e9;CABIE","firstname":"Andr\u00e9","lastname":"CABIE","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/0376kfa34","role":"organisation id"},{"title":"SIREN","uri":"200034528","role":"organisation id"}],"email":"andre.cabie@chu-martinique.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE LA MARTINIQUE","PILabo":"","isContact":true}],"oth_id":[{"name":"Reacting","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE LA MARTINIQUE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/0376kfa34","role":"sponsor id"},{"title":"SIREN","uri":"200034528","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01wp0c315"},{"title":"SIREN","uri":"130016546"}]}]},"distribution_statement":{"contact":[{"name":"Andr\u00e9;CABIE","lastname":"CABIE","firstname":"Andr\u00e9","type":"contact","email":"andre.cabie@chu-martinique.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE LA MARTINIQUE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/0376kfa34","role":"organisation id","title":"ROR"},{"uri":"200034528","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Dengue"},{"keyword":"Chikungunya"},{"keyword":"Guyane"},{"keyword":"virus"},{"keyword":"infection"},{"keyword":"prise en charge"},{"keyword":"Zika"},{"keyword":"arboviroses"},{"keyword":"Antilles"},{"keyword":"France"}],"topics":[{"topic":"Immunologie m\u00e9dicale","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/7a3cf568-46ba-4840-be8f-f22fc030139f"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D000486"}]},{"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":"Certaines maladies infectieuses ou parasitaires","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1435254666","title":"CIM-11"}]},{"topic":"D\u00e9terminants biologiques : Pr\u00e9dispositions g\u00e9n\u00e9tiques","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques","vocab":"health determinant"}],"purpose":"D\u00e9crire les facteurs d\u00e9mographiques, cliniques, biologiques, virologiques, immunologiques et g\u00e9n\u00e9tiques associ\u00e9s \u00e0, ou pr\u00e9dictif de la survenue d\u2019une \u00e9volution s\u00e9v\u00e8re d\u2019une arbovirose (\u00e9tat de choc, h\u00e9morragie interne, d\u00e9faillance visc\u00e9rale, d\u00e9c\u00e8s) dans une cohorte d\u2019enfants et d\u2019adultes atteints d\u2019une arbovirose confirm\u00e9e virologiquement pris en charge en milieu hospitalier, dans les d\u00e9partements et r\u00e9gions d\u2019outre-mer et en France m\u00e9tropolitaine.","abstract":"","coll_dates":[{"start":"2010-01-01","end":"2019-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Ile-de-France','Guadeloupe','Guyane','Martinique','La R\u00e9union']","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\": \"Nouveau-n\u00e9 (naissance \u00e0 28j)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007231\"\n            }\n        },\n        {\n            \"value\": \"Nourrisson (28j \u00e0 2 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007223\"\n            }\n        },\n        {\n            \"value\": \"Petite enfance (2 \u00e0 5 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002675\"\n            }\n        },\n        {\n            \"value\": \"Enfance (6 \u00e0 12 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        },\n        {\n            \"value\": \"Adolescence (13 \u00e0 18 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000293\"\n            }\n        },\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\": \"1. Adulte, enfant ou nouveau-n\u00e9 > de 2.5kg le jour de l\u2019inclusion.   2. Recours \u00e0 un des services hospitaliers participant \u00e0 la recherche, en salle d\u2019urgence, en hospitalisation compl\u00e8te, en hospitalisation de jour ou en consultation externe.  3. Arbovirose suspect\u00e9e, ou biologiquement confirm\u00e9e: Un cas suspect d\u2019arbovirose est d\u00e9fini par : - l\u2019association d\u2019au moins 2 signes clinico-biologiques \u00e9vocateurs d\u2019une arbovirose : fi\u00e8vre (signal\u00e9e par le patient ou la famille, ou document\u00e9e), c\u00e9phal\u00e9es, \u00e9ruption cutan\u00e9e, myalgies, arthralgies, douleurs abdominales, h\u00e9morragies, thrombop\u00e9nie, ou - pour les enfants de moins de 6 ans : par le signalement (par la famille ou document\u00e9e) d\u2019une fi\u00e8vre le jour de l\u2019inclusion ou dans les 7 jours pr\u00e9c\u00e9dent, accompagn\u00e9e \u00e9ventuellement d\u2019une douleur. - Chez un patient avec une notion de s\u00e9jour dans les 2 semaines pr\u00e9c\u00e9dant la consultation dans une zone de circulation des arbovirus (pour les cas import\u00e9s uniquement) Un cas d\u2019arbovirose confirm\u00e9 biologiquement est d\u00e9fini par : - Une RT-PCR plasmatique ou RT-PCR urinaire (virus Zika) positive \u00e0 un arbovirus, ou par la d\u00e9tection de l\u2019antig\u00e8ne NS1 (dengue), ou apparition ou augmentation significative (multiplication du titre par quatre) d\u2019immunoglobulines G dirig\u00e9es contre l\u2019arbovirus en question sur un s\u00e9rum pr\u00e9lev\u00e9 pr\u00e9cocement (au cours de la premi\u00e8re semaine suivant le d\u00e9but des sympt\u00f4mes) et un autre pr\u00e9lev\u00e9 au moins 10 jours plus tard.   4. D\u00e9but du ou des sympt\u00f4mes dans les 7 jours pr\u00e9c\u00e9dant la visite d\u2019inclusion, sauf pour les formes s\u00e9v\u00e8res pour lesquelles l\u2019inclusion peut se faire jusqu\u2019au 21e jour.   5. Acceptation de participer \u00e0 l\u2019\u00e9tude et au suivi propos\u00e9, et signature du consentement \u00e9clair\u00e9 sign\u00e9 par la personne (adulte et mineur en \u00e2ge d\u2019exprimer sa volont\u00e9) ou un de ses repr\u00e9sentants (mineurs non en \u00e2ge d\u2019exprimer sa volont\u00e9, incapacit\u00e9 \u00e0 signer le consentement).\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es paracliniques','Donn\u00e9es biologiques','Donn\u00e9es paracliniques (hors biologiques) : Imagerie']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Le centre de M\u00e9thodologie et de gestion des donn\u00e9es est le CIC Antilles-Guyane (CIC1424). La saisie des donn\u00e9es est effectu\u00e9e sur la plate-forme Clinsight\u00ae du CIC Antilles-Guyane.']"}},"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\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 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":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"1377"},"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\":\"Acc\u00e8s r\u00e9serv\u00e9\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Contacter le responsable scientifique","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":"11-07-2016","lastUpdatedAuto":null,"lastUpdatedManual":"29-10-2020","isContributorPI":false,"contributorName":"Andr\u00e9 CABIE","contributorAffiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE LA MARTINIQUE","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":true},"collaborations":{"networkConsortium":true},"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":"Pour chaque patient, il est pr\u00e9vu un recueil \u00e9lectronique des donn\u00e9es. Il existe n\u00e9anmoins un support papier permettant si n\u00e9cessaire un remplissage diff\u00e9r\u00e9 du cahier d\u2019observation \u00e9lectronique.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"Antilles, Guyane, France metropolitaine"},"dataTypes":{"clinicalDataDetails":"Signes et sympt\u00f4mes cardinaux et non cardinaux d'une arbovirose. Photographies des manifestations dermatologiques et musculo-squelettiques (si disponibles dans le cadre de soins).\u00c9valuation de la douleur sur une \u00e9chelle visuelle analogique, - \u00c9valuation de la composante neuropathique de la douleur par le questionnaire DN4, - \u00c9valuation de l\u2019\u00e9tat g\u00e9n\u00e9ral du patient ainsi que l\u2019atteinte articulaire par les scores MDHAQ et RAPID3 .\u00c9valuation de la qualit\u00e9 du sommeil et de la qualit\u00e9 de vie par des scores sp\u00e9cifiques valid\u00e9s","biologicalDataDetails":"La vir\u00e9mie plasmatique mesur\u00e9e par qRT-PCR-arbovirus sp\u00e9cifique, Le titre d\u2019anticorps sp\u00e9cifiques contre un arbovirus en particulier IgM, IgG et IgA.","isDataInBiobank":true,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}