{"doc_desc":{"title":"Descriptive and prognostic study of arbovirus infections in France, based on a hospital cohort of children and adults with suspected arbovirose","idno":"FRESH-PEF73337-en","producers":[{"name":"Andr\u00e9 CABIE","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE LA MARTINIQUE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73337-en","IDno":{"metadata_no":[{"agency":"PEF","code":"73337"},{"agency":"FReSH","code":"FRESH-PEF73337"}]},"title":"Descriptive and prognostic study of arbovirus infections in France, based on a hospital cohort of children and adults with suspected arbovirose","alternate_title":"CARBO"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Andr\u00e9;CABIE","PILabo":"","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE LA MARTINIQUE","extlink":[{"title":"ORCID","uri":"0000-0003-0117-3061","role":"pi id"},{"title":"IdRef","uri":"08145094X","role":"pi id"},{"title":"SIREN","uri":"200034528","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"andre.cabie@chu-martinique.fr","isContact":"Yes"}],"oth_id":[{"name":"Reacting","type":"collaboration"}],"production_statement":{"prod_place":"Epidemiology France Portal (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","email":"andre.cabie@chu-martinique.fr","type":"contact","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":"French Guiana"},{"keyword":"virus"},{"keyword":"infection"},{"keyword":"management"},{"keyword":"Zika"},{"keyword":"West Indies"},{"keyword":"France"},{"keyword":"Arboviruses"}],"topics":[{"topic":"Clinical immunology","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":"Infectious disease medicine","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":"Certain infectious or parasitic diseases","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1435254666","title":"CIM-11"}]},{"topic":"Biological determinants: Genetic predisposition","vocab":"health determinant"},{"topic":"Biological determinants","vocab":"health determinant"}],"purpose":"To identify demographic, clinical, biological, virologic, immunologic and genetic factors associated with or predictive of severe complications of arbovirus infections (shock, internal bleeding, organ failure, death) in a cohort of children and adults with confirmed arbovirus infections, in France.","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":"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\": \"Infant, Newborn (birth to 28 days)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007231\"\n            }\n        },\n        {\n            \"value\": \"Infant (28 days to 2 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007223\"\n            }\n        },\n        {\n            \"value\": \"Child, Preschool (2 to 5 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002675\"\n            }\n        },\n        {\n            \"value\": \"Child (6 to 12 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        },\n        {\n            \"value\": \"Young Adult (19 to 24 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\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            \"value\": \"Aged, 80 and over (80 years and more)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Adult, child or newborn with a weight > 2.5 kg the days of enrollment. - Consulting a participating hospital center (emergency room, full hospitalization, day hospitalization, or outpatient visit). - Arbovirosis suspected or confirmed biologically: A suspected case of arbovirus infection is defined by: - The combination of clinical and biological signs observed on the day of enrollment or during the previous 7 days: fever (reported by the patient or family, or documented) and two or more of the following signs: headache, rash, myalgia, arthralgia, abdominal pain, hemorrhage, thrombocytopenia, or - Children under 6 years: the report (by family or documented) of a fever on the day of enrollment or within 7 previous days, possibly accompanied by a of pain greater than or equal to 4\\\/10 on hetero assessment scale age age-appropriate  - At a patient with a notion of stay in 2 weeks preceding in a zone of arbovirus circulation (only for the imported cases)   A case of arbovirus infection confirmed biologically is defined by: - RT-PCR arbovirus positive in plasma or urine (Zika virus infection), or by detection of the NS1 antigen (dengue), or an appearance or an significant increase (multiplication of the title by four) of the G immunoglobulin  directed against arbovirus in question on an early taken serum ( during the first week following the start of symptoms) and another taken at least 10 days later.. - Symptom onset within the seven days before the enrollment visit or within 21 days for severe forms of the disease.Possibility of follow-up throughout study period.  - Acceptance to participate in the study and in follow-up; informed consent of the patient (adult and minor in age to express his desire) or a legal representative (for minors, and patients unable to sign the consent form).\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological data','Paraclinical data (non-biological) : Imaging']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['The Methodology and Data Management centre is the CIC Antilles-Guyane (CIC1424). Data entry is carried out on the Clinsight\u00ae platform of the CIC Antilles-Guyane.']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth event\/mortality\r\nHealth care consumption and services\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 organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[1000-10000[ individuals","response_rate":"1377"},"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\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Contact the principal investigator","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":"11-07-2016","lastUpdatedAuto":null,"lastUpdatedManual":"29-10-2020","isContributorPI":"No","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":"Yes"},"collaborations":{"networkConsortium":"Yes"},"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":"An electronic data collection is provided for each patient. There is nevertheless a paper medium allowing, if necessary, delayed filling in of the electronic observation log.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"West Indies, French Guiana, metropolitan France"},"dataTypes":{"clinicalDataDetails":"Cardinal and noncardinal signs and symptoms of an arbovirus. Photographs of dermatological and musculoskeletal manifestations (if available as part of the care). Assessment of pain intensity on a visual analogue scale, Evaluation of the neuropathic components of pain using the DN4 questionnaire, Evaluation of the general condition of the patient as well as the articular involvement by MDHAQ and RAPID3 scores. Assessment of quality of sleep and quality of life by validated specific scores","biologicalDataDetails":"The plasma viraemia measured by specific qRT-PCR-arbovirus, the titre of specific antibodies against an arbovirus, in particular IgM, IgG and IgA.","isDataInBiobank":"Yes","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}