{"doc_desc":{"title":"Cohorte de jeunes adultes avec rachialgie inflammatoire r\u00e9cente","idno":"FRESH-PEF60152-fr","producers":[{"name":" COHORTE DESIR","affiliation":"SOCIETE FRAN\u00c7AISE DE RHUMATOLOGIE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60152-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60152"},{"agency":"FReSH","code":"FRESH-PEF60152"}]},"title":"Cohorte de jeunes adultes avec rachialgie inflammatoire r\u00e9cente","alternate_title":"DESIR"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Maxime;DOUGADOS","PILabo":"H\u00d4PITAL \/ SERVICE DE RHUMATOLOGIE DU PR DOUGADOS H\u00d4PITAL COCHIN","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ORCID","uri":"0000-0003-3009-6229","role":"pi id"},{"title":"IdRef","uri":"029127246","role":"pi id"},{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"maxime.dougados@aphp.fr","isContact":"Oui"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00pg5jh14","role":"sponsor id"},{"title":"SIREN","uri":"267500452","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"SOCIETE FRAN\u00c7AISE DE RHUMATOLOGIE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/04g47ec58"}]},{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261"},{"title":"SIREN","uri":"180036048"}]},{"name":"PFIZER (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02c9yny10"},{"title":"SIREN","uri":"433623550"}]}]},"distribution_statement":{"contact":[{"name":"Maxime;DOUGADOS","email":"maxime.dougados@aphp.fr","type":"contact","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id","title":"ROR"},{"uri":"267500452","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"histoire naturelle"},{"keyword":"facteurs pr\u00e9dictifs"},{"keyword":"d\u00e9veloppement"},{"keyword":"facteurs de progression"},{"keyword":"facteurs g\u00e9n\u00e9tiques"},{"keyword":"ethniques et environnementaux"},{"keyword":"impacts humains"},{"keyword":"\u00e9conomiques"}],"topics":[{"topic":"Rhumatologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/bfb0bafd-7894-45ba-84fc-ddab5fd6c537"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D012219"}]},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux : Climat","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux : Autres","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques : Pr\u00e9dispositions g\u00e9n\u00e9tiques","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques","vocab":"health determinant"}],"purpose":"Objectif g\u00e9n\u00e9ral : 1) \u00c9tudier l'histoire naturelle des rachialgies inflammatoires r\u00e9centes 2) Identifier les facteurs pr\u00e9dictifs de d\u00e9veloppement d'une spondylarthropathie et les facteurs de progression de la maladie, incluant les facteurs g\u00e9n\u00e9tiques, ethniques et environnementaux 3) \u00c9tudier les impacts humains et \u00e9conomiques des patients avec une rachialgie inflammatoire r\u00e9cente","abstract":"","coll_dates":[{"start":"2007-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"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    \"level_type_clusion_I\": \"Population g\u00e9n\u00e9rale\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Homme ou femme de plus de 18 ans et de moins de 50 ans, avec rachialgie inflammatoire r\u00e9cente d\u00e9finie par : - douleur localis\u00e9e au rachis lombaire ou dorsal ou fessalgie ; - r\u00e9pondant aux crit\u00e8res de Calin ou de Berlin ou aux deux ; - dur\u00e9e des sympt\u00f4mes sup\u00e9rieure \u00e0 3 mois et inf\u00e9rieure \u00e0 3 ans. Symptomatologie susceptible, d'apr\u00e8s le m\u00e9decin, d'\u00eatre en rapport avec une spondylarthropathie (sup\u00e9rieure ou \u00e9gale \u00e0 5 sur une \u00e9chelle de 0 \u00e0 10). R\u00e9alisation d'un examen m\u00e9dical pr\u00e9alable. Consentement \u00e9clair\u00e9 dat\u00e9 et sign\u00e9 volontairement.\",\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":"['Pr\u00e9sence d\\'une requ\u00eate de coh\u00e9rence apr\u00e8s la saisie des donn\u00e9es informatiques.Gestion des donn\u00e9es manquantes par retour au dossier source.Relance des m\u00e9decins pour r\u00e9aliser les visites de suivi.Les patients sont inform\u00e9s de l\\'utilisation de leur donn\u00e9es.']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/mortalit\u00e9\r\nConsommation de soins\/services de sant\u00e9"}]},"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":"[500-1000[ individus","response_rate":"708"},"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":"N\u2019importe quel chercheur de n\u2019importe quel pays peut soumettre un projet de recherche au Comit\u00e9 Scientifique de la Cohorte. Si ce projet est accept\u00e9, les donn\u00e9es de la cohorte sont disponibles, que ce soit la base de donn\u00e9es cliniques que le mat\u00e9riel biologique et\/ou le mat\u00e9riel d\u2019imagerie.","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":"05-08-2014","isContributorPI":"Non","contributorName":" COHORTE DESIR","contributorAffiliation":"SOCIETE FRAN\u00c7AISE DE RHUMATOLOGIE","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"Liste des publications dans HAL","link":"http:\/\/tinyurl.com\/HAL-DESIR"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Priv\u00e9 \u00e0 but non lucratif","Public (France)","Industrie"],"otherFundingAgentType":["","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Oui","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 avec double saisie Entretiens : saisie directe Examens cliniques : \u00e9tape manuscrite avec double saisie Examens biologiques : \u00e9tape manuscrite avec double saisie","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Cohorte multicentrique fran\u00e7aise (25 centres)"},"dataTypes":{"clinicalDataDetails":"Examen clinique \u00e0 l\u2019inclusion et au cours du suivi","biologicalDataDetails":"Type de pr\u00e9l\u00e8vements r\u00e9alis\u00e9s : s\u00e9rum, urine, ADN, ARN","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}