{"doc_desc":{"title":"Development of Early Undifferentiated Spondyloarthritis","idno":"FRESH-PEF60152-en","producers":[{"name":" COHORTE DESIR","affiliation":"SOCIETE FRAN\u00c7AISE DE RHUMATOLOGIE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60152-en","IDno":{"metadata_no":[{"agency":"PEF","code":"60152"},{"agency":"FReSH","code":"FRESH-PEF60152"}]},"title":"Development of Early Undifferentiated Spondyloarthritis","alternate_title":"DESIR"},"study_authorization":{"agency":[]},"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 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(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":"Natural history"},{"keyword":"predictive factors"},{"keyword":"development"},{"keyword":"progressive factors"},{"keyword":"genetic factors"},{"keyword":"ethnic and environmental factors"},{"keyword":"human impact"},{"keyword":"economic"}],"topics":[{"topic":"Rheumatology","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":"Behavioral determinants","vocab":"health determinant"},{"topic":"Environmental determinants: Climate","vocab":"health determinant"},{"topic":"Environmental determinants","vocab":"health determinant"},{"topic":"Environmental determinants: Other","vocab":"health determinant"},{"topic":"Biological determinants: Genetic predisposition","vocab":"health determinant"},{"topic":"Biological determinants","vocab":"health determinant"}],"purpose":"1) To study the natural history of early inflammatory back pain 2) To identify predictive factors for the development of spondyloarthritis and progressive factors of the disease, including genetic, ethnic and environmental factors 3) To study the human and economic impact of patients with early inflammatory back pain.","abstract":"","coll_dates":[{"start":"2007-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"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    \"level_type_clusion_I\": \"General population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Men or women over 18 and under 50 years old, presenting early inflammatory back pain defined by: - pain in the buttock, lumbar or thoracic spine region; - fulfilling either the Calin or Berlin criteria or both; - symptom duration more than 3 months and less than 3 years. Symptoms suggestive of spondyloarthritis according to physician's assessment (score greater or equal to 5 on a 0 to 10 rating scale). Realisation of a prior medical examination. Informed consent dated and signed voluntarily.\",\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":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/mortality\r\nHealth care consumption and services"}]},"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\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Self-administered questionnaire\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[500-1000[ individuals","response_rate":"708"},"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":"Researchers from any country can submit a research project to the Cohort Scientific Committee. If the project is approved, cohort data will be made available whether it is the clinical database or biological material and\/or imaging equipment.","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":"08-03-2013","lastUpdatedAuto":null,"lastUpdatedManual":"05-08-2014","isContributorPI":"No","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":["Private non-profit","Public (France)","Industry"],"otherFundingAgentType":["","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"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":"Self-administered questionnaire: double data entry from a paper questionnaire Interview: direct input Clinical Examinations: handwritten with double data entry Biological analysis: handwritten with double data entry","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"Multicentric cohort throughout France (25 centres)"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"Type of samples taken: serum, urine, DNA, RNA","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}