{"doc_desc":{"title":"Etude longitudinale sur des patients atteints du lupus \u00e9ryth\u00e9mateux syst\u00e9mique: validation du systemic lupus activity questionnaire (slaq) et du lupus quality of life (lupus qol)","idno":"FRESH-PEF60147-fr","producers":[{"name":"Claire BONITHON-KOPP","affiliation":"chu"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60147-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60147"},{"agency":"FReSH","code":"FRESH-PEF60147"}]},"title":"Etude longitudinale sur des patients atteints du lupus \u00e9ryth\u00e9mateux syst\u00e9mique: validation du systemic lupus activity questionnaire (slaq) et du lupus quality of life (lupus qol)","alternate_title":"FRESH QOLA"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Claire;BONITHON-KOPP","firstname":"Claire","lastname":"BONITHON-KOPP","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/0377z4z10","role":"organisation id"},{"title":"SIREN","uri":"262100076","role":"organisation id"}],"email":"bonithon@u-bourgogne.fr","affiliationName":"chu","PILabo":"CHU \/ CHU DIJON \/ INSERM CIE 1 UNIVERSIT\u00c9 DE BOURGOGNE","isContact":true},{"name":"Francis;GUILLEMIN","firstname":"Francis","lastname":"GUILLEMIN","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/016ncsr12","role":"organisation id"},{"title":"SIREN","uri":"200042166","role":"organisation id"}],"email":"francis.guillemin@univ-lorraine.fr","affiliationName":"chu","PILabo":"CHU \/ CHU NANCY \/ INSERM CIE6","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE DIJON","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/0377z4z10","role":"sponsor id"},{"title":"SIREN","uri":"262100076","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"LUPUS FRANCE","extlink":[{"title":"SIREN","uri":"477770614"}]}]},"distribution_statement":{"contact":[{"name":"Claire;BONITHON-KOPP","lastname":"BONITHON-KOPP","firstname":"Claire","type":"contact","email":"bonithon@u-bourgogne.fr","affiliationName":"chu","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/0377z4z10","role":"organisation id","title":"ROR"},{"uri":"262100076","role":"organisation id","title":"SIREN"}]},{"name":"Francis;GUILLEMIN","lastname":"GUILLEMIN","firstname":"Francis","type":"contact","email":"francis.guillemin@univ-lorraine.fr","affiliationName":"chu","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/016ncsr12","role":"organisation id","title":"ROR"},{"uri":"200042166","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"pouss\u00e9es"},{"keyword":"traduire"},{"keyword":"fran\u00e7ais"},{"keyword":"qualit\u00e9 de vie"},{"keyword":"questionnaire"}],"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":"Dermatologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/5375c411-6db9-40ed-a854-6554102a587b"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D003880"}]},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques : Emploi","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"}],"purpose":"Objectif g\u00e9n\u00e9ral : Traduire et valider en langue fran\u00e7aise le systemic lupus activity questionnaire et le lupus quality of life","abstract":"","coll_dates":[{"start":"2009-01-01","end":"2010-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Grand Est','Bourgogne Franche-Comt\u00e9']","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    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \" patients r\u00e9pondants aux crit\u00e8res ACR 1997 de classification du lupus \u00e9ryth\u00e9mateux syst\u00e9mique ; - patients capables de comprendre le fran\u00e7ais parl\u00e9 et \u00e9crit ; - patients \u00e2g\u00e9s de 18 \u00e0 75 ans ; - patients ayant re\u00e7u l\u2019information orale et \u00e9crite portant sur la recherche.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Pr\u00e9sence d\\'une requ\u00eate de coh\u00e9rence apr\u00e8s la saisie des donn\u00e9es informatiques Gestion des donn\u00e9es manquantes par retour vers un tiers Relance des sujets pour r\u00e9aliser les visites de suivi V\u00e9rification des crit\u00e8res d\\'inclusion + contr\u00f4les des donn\u00e9es saisies (donn\u00e9es manquantes et incoh\u00e9rentes) + monitoring des consentements Les patients sont inform\u00e9s de l\\'utilisation de leur donn\u00e9es']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Qualit\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\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Questionnaire auto-administr\u00e9\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"< 500 individus","response_rate":"13"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"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":"Utilisation possible des donn\u00e9es par des \u00e9quipes acad\u00e9miques \u00e0 d\u00e9terminer Utilisation non possible des donn\u00e9es par des industriels","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":"08-03-2013","lastUpdatedAuto":null,"lastUpdatedManual":"06-08-2014","isContributorPI":false,"contributorName":"Claire BONITHON-KOPP","contributorAffiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE DIJON","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"Liste des publications dans HAL","link":"http:\/\/tinyurl.com\/Hal-FRESH-QOLA"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Priv\u00e9 \u00e0 but non lucratif"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"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":"Auto-questionnaire : saisie \u00e0 partir d\u2019un questionnaire papier (saisie manuelle) avec double saisie Entretiens : saisie \u00e0 partir d\u2019un questionnaire papier (saisie manuelle) avec double saisie Examens cliniques : \u00e9tape manuscrite (saisie manuelle) avec double saisie","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"Cohorte multicentrique (6 centres) fran\u00e7aise de l'inter-r\u00e9gion Est"},"dataTypes":{"clinicalDataDetails":"Examen clinique \u00e0 l\u2019inclusion et au cours du suivi tous les deux ansInformations recueillies lors de l'examen clinique : crit\u00e8res d'inclusion, d'exclusion, appr\u00e9ciation globale de la maladie, traitement, \u00e9volution de la maladie","biologicalDataDetails":"","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}