{"doc_desc":{"title":"\u00c9tude d\u2019impl\u00e9mentation du score HOME-CoV r\u00e9vis\u00e9 pour guider le choix d\u2019une hospitalisation ou d\u2019une prise en charge ambulatoire des patients ayant une infection \u00e0 SARS-CoV-2 av\u00e9r\u00e9e ou probable admis aux urgences.","idno":"FRESH-PEF73909-fr","producers":[{"name":"","affiliation":""}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73909-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73909"},{"agency":"FReSH","code":"FRESH-PEF73909"}]},"title":"\u00c9tude d\u2019impl\u00e9mentation du score HOME-CoV r\u00e9vis\u00e9 pour guider le choix d\u2019une hospitalisation ou d\u2019une prise en charge ambulatoire des patients ayant une infection \u00e0 SARS-CoV-2 av\u00e9r\u00e9e ou probable admis aux urgences.","alternate_title":"Revised HOME-CoV"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Delphine;DOUILLET","firstname":"Delphine","lastname":"DOUILLET","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/0250ngj72","role":"organisation id"},{"title":"SIREN","uri":"264900036","role":"organisation id"}],"email":"Delphine.Douillet@chu-angers.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE D'ANGERS","PILabo":"CENTRE HOSPITALIER UNIVERSITAIRE D'ANGERS \/ D\u00e9partement de M\u00e9decine d'Urgence","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE D'ANGERS","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/0250ngj72","role":"sponsor id"},{"title":"SIREN","uri":"264900036","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE D'ANGERS","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/0250ngj72"},{"title":"SIREN","uri":"264900036"}]}]},"distribution_statement":{"contact":[{"name":"Delphine;DOUILLET","lastname":"DOUILLET","firstname":"Delphine","type":"contact","email":"Delphine.Douillet@chu-angers.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE D'ANGERS","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/0250ngj72","role":"organisation id","title":"ROR"},{"uri":"264900036","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"COVID-19"},{"keyword":"Hospitalization"},{"keyword":"Outpatient"},{"keyword":"Rule validation"},{"keyword":"Expert consensus"},{"keyword":"Rule-based decision-making"},{"keyword":"Clinical support decision tool."}],"topics":[{"topic":"M\u00e9decine d\u2019urgence","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/5e1591e2-d02b-436c-8216-6b8912eee467"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D004635"}]},{"topic":"Certaines autres maladies virales","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1136802325","title":"CIM-11"}]},{"topic":"COVID-19","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1730556128","title":"CIM-11"}]},{"topic":"Syst\u00e8mes de soins et acc\u00e8s aux soins","vocab":"health determinant"}],"purpose":"L\u2019objectif principal est de d\u00e9montrer la fiabilit\u00e9 et la s\u00e9curit\u00e9 de la prise en charge ambulatoire chez les patients hautement suspects ou confirm\u00e9s atteints de la COVID-19 se pr\u00e9sentant aux urgences et ayant un score HOME-CoV r\u00e9vis\u00e9 inf\u00e9rieur \u00e0 2 (r\u00e8gle n\u00e9gative). Les objectifs secondaires sont : i. \u00c9valuer le taux de patients ayant n\u00e9cessit\u00e9 une hospitalisation dans les 7 jours suivant l\u2019inclusion selon la r\u00e8gle HOME-CoV r\u00e9vis\u00e9e positive ou n\u00e9gative. ii. \u00c9valuer le taux de patients ayant n\u00e9cessit\u00e9 une hospitalisation et l\u2019initiation d\u2019une oxyg\u00e9noth\u00e9rapie dans les 7 jours suivant l\u2019inclusion selon la r\u00e8gle HOME-CoV r\u00e9vis\u00e9e positive ou n\u00e9gative. iii. \u00c9valuer le taux de patients ayant n\u00e9cessit\u00e9 une intubation dans les 7 jours suivant l\u2019inclusion selon la r\u00e8gle HOME-CoV r\u00e9vis\u00e9e positive ou n\u00e9gative. iv. \u00c9valuer le taux de patients d\u00e9c\u00e9d\u00e9s toutes causes confondues dans les 7 jours suivant l\u2019inclusion selon la r\u00e8gle HOME-CoV r\u00e9vis\u00e9e positive ou n\u00e9gative. v. \u00c9valuer les performances du score HOME-CoV r\u00e9vis\u00e9 pour pr\u00e9dire l\u2019\u00e9volution d\u00e9favorable dans le sous-groupe des patients ayant une infection \u00e0 SARS-CoV-2 confirm\u00e9e par RT-PCR pour exclure le risque de survenue d\u2019une \u00e9volution d\u00e9favorable lorsqu\u2019ils sont \u00e9valu\u00e9s \u00e0 bas risque. vi. Comparer les performances du score HOME-CoV r\u00e9vis\u00e9 \u00e0 celles des autres scores existants.","abstract":"","coll_dates":[{"start":"","end":""}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}},{"name":"Belgique","abbreviation":"be","extLink":{"vocab":"ISO","vocabURI":"be"}}],"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\": \"Patient adulte (> 18 ans), - Consultant un des services d\u2019urgences participant \u00e0 l\u2019\u00e9tude pour une infection \u00e0 COVID-19 confirm\u00e9e par une RT-PCR \u00e0 SARS-CoV2 positive ou consid\u00e9r\u00e9e comme tr\u00e8s probable par le m\u00e9decin le prenant en charge, - Ne n\u00e9cessitant pas une prise en charge en unit\u00e9 de soins continus ou de r\u00e9animation et n\u2019ayant pas fait l\u2019objet d\u2019une d\u00e9cision de limitations des th\u00e9rapeutiques actives, - Ayant donn\u00e9 son consentement expr\u00e8s pour participer \u00e0 l\u2019\u00e9tude, - Affili\u00e9 ou b\u00e9n\u00e9ficiaire d\u2019un r\u00e9gime de s\u00e9curit\u00e9 sociale.\",\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 socio-d\u00e9mographiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[]},"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\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"1300 patients"},"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":"03-02-2021","lastUpdatedAuto":null,"lastUpdatedManual":"05-05-2021","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"France Belgium"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":"","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}