{"doc_desc":{"title":"Study on the implementation of the revised HOME-CoV score to guide the choice of hospitalisation or outpatient management of patients with confirmed or probable SARS-CoV-2 infection admitted to an emergency department.","idno":"FRESH-PEF73909-en","producers":[{"name":"","affiliation":""}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73909-en","IDno":{"metadata_no":[{"agency":"PEF","code":"73909"},{"agency":"FReSH","code":"FRESH-PEF73909"}]},"title":"Study on the implementation of the revised HOME-CoV score to guide the choice of hospitalisation or outpatient management of patients with confirmed or probable SARS-CoV-2 infection admitted to an emergency department.","alternate_title":"Revised HOME-CoV"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Delphine;DOUILLET","PILabo":"CENTRE HOSPITALIER UNIVERSITAIRE D'ANGERS \/ D\u00e9partement de M\u00e9decine d'Urgence","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE D'ANGERS","extlink":[{"title":"ORCID","uri":"0000-0001-7986-7552","role":"pi id"},{"title":"IdRef","uri":"19555275X","role":"pi id"},{"title":"SIREN","uri":"264900036","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"Delphine.Douillet@chu-angers.fr","isContact":"Yes"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (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","email":"Delphine.Douillet@chu-angers.fr","type":"contact","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":[],"topics":[{"topic":"Emergency medicine","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":"Certain other viral diseases","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"}]}],"purpose":"The primary objective is to demonstrate the reliability and safety of outpatient management among patients highly suspected or confirmed as infected with COVID-19, attending an emergency department and with a revised HOME-CoV score less than 2 (negative rule). The secondary objectives are as follows: i. Evaluate the rate of patients having required hospitalisation within 7\u00a0days following inclusion according to the revised positive or negative HOME-CoV rule. ii. Evaluate the rate of patients having required hospitalisation and initiation of oxygen therapy within 7\u00a0days following inclusion according to the revised positive or negative HOME-CoV rule. iii. Evaluate the rate of patients having required intubation within 7\u00a0days following inclusion according to the revised positive or negative HOME-CoV rule. iv. Evaluate the rate of all-cause deaths within 7\u00a0days following inclusion according to the revised positive or negative HOME-CoV rule. v. Evaluate the performance of the revised HOME-CoV score in predicting a negative outcome in the patient subgroup with SARS-CoV-2 infection confirmed by RT-PCR to rule out the risk of a negative outcome when assessed as low risk. vi. Compare the performance of the revised HOME-CoV score with that of other existing scores.","abstract":"","coll_dates":[{"start":"","end":""}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}},{"name":"Belgium","abbreviation":"be","extLink":{"vocab":"ISO","vocabURI":"be"}}],"geog_coverage":"","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\": \"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 patient (> 18\u00a0years), - Attending one of the emergency departments taking part in the study due to COVID-19 infection confirmed by SARS-CoV-2 positive RT-PCR, or considered highly probable by the physician managing the patient, - Not requiring management in a continuous care or intensive care unit, and subject to a decision to limit active treatment, - Having given their formal consent to take part in the study, - Registered with or a beneficiary of a social security scheme.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological data','Socio-demographic data']","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\":\"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\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"","sources":[],"target_sample_size":"[1000-10000[ individuals","response_rate":"1,300 patients"},"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\":\"To be defined\",\"extLink\":[]}"},"dataset_use":{"restrictions":"","conditions":"","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":"03-02-2021","lastUpdatedAuto":null,"lastUpdatedManual":"05-05-2021","isContributorPI":"No","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":"No"},"geographicalCoverage":{"geoDetail":"France Belgium"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":"","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}