{"doc_desc":{"title":"Knee and Hip Osteoarthritis Long Term Assessment Cohort","idno":"FRESH-PEF60059-en","producers":[{"name":"Francis GUILLEMIN","affiliation":"chu"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60059-en","IDno":{"metadata_no":[{"agency":"PEF","code":"60059"},{"agency":"FReSH","code":"FRESH-PEF60059"}]},"title":"Knee and Hip Osteoarthritis Long Term Assessment Cohort","alternate_title":"KHOALA"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Francis;GUILLEMIN","PILabo":"CHU \/ CENTRE D'EPIDEMIOLOGIE CLINIQUE CIC-EC INSERM CIE6 NANCY. EA4003 CHU NANCY","affiliationName":"chu","extlink":[{"title":"ORCID","uri":"0000-0002-9860-7024","role":"pi id"},{"title":"IdRef","uri":"068536569","role":"pi id"},{"title":"SIREN","uri":"200042166","role":"organisation id"},{"title":"RNSR","uri":"199520127D","role":"labo id"}],"email":"francis.guillemin@univ-lorraine.fr","isContact":"Yes"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"CENTRE HOSPITALIER REGIONAL ET UNIVERSITAIRE DE NANCY","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/016ncsr12","role":"sponsor id"},{"title":"SIREN","uri":"200042166","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"SOCIETE FRAN\u00c7AISE DE RHUMATOLOGIE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/04g47ec58"}]},{"name":"CENTRE HOSPITALIER REGIONAL ET UNIVERSITAIRE DE NANCY","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/016ncsr12"},{"title":"SIREN","uri":"200042166"}]},{"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":"SANTE PUBLIQUE FRANCE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00dfw9p58"},{"title":"SIREN","uri":"130022338"}]},{"name":"CNAM","extlink":[]},{"name":"","extlink":[]}]},"distribution_statement":{"contact":[{"name":"Francis;GUILLEMIN","email":"francis.guillemin@univ-lorraine.fr","type":"contact","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":"Prosthesis"},{"keyword":"quality of life"},{"keyword":"healthcare usage"}],"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":"Osteoarthritis","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/558562409","title":"CIM-11"}]}],"purpose":"General objective: To describe the natural history of symptomatic hip and knee osteoarthritis and to to identify predictive factors of its consequences in terms of pain, functional incapacity, quality of life and healthcare (medical care, use of healthcare resources and illness cost). Patients for this cohort study are identified during a national prevalence study. Secondary objectives: - to investigate predictive factors for quality of life, changes in quality of life and hip or knee replacement such as: socio-demographic parameters, clinical factors, comorbidities, perceived health parameters at baseline (quality of life, functional capacity), x-rays and biological markers; - to identify factors that influence healthcare usage, social impact and treatment for symptomatic hip and knee osteoarthritis; - to collect and store biological samples (serum bank and DNA bank), x-rays, clinical and perceived health data in order to form a platform for other research projects, such as physiopathological projects on cellular and molecular mechanisms of osteoarthritis and genetic projects. This cohort will benefit from the advantages of the descriptive prevalence study and will allow the recruitment of a general population based representative sample.","abstract":"","coll_dates":[{"start":"2007-01-01","end":"2019-01-01"}],"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\": \"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    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Men and women between 40 and 75 years of age - Symptomatic uni- or bilateral knee (tibio-femoral) and hip osteoarthritis with confirmed diagnosis that meets EULAR and ACR criteria, identified from prevalent cases in France during cohort formation\",\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\/morbidity\r\nHealth event\/mortality"}]},"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":"878"},"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":"Data may be used by academic teams. Data may be use by industrial teams.","conditions":"Access conditions: https:\/\/cohortekhoala.blogspot.com\/ Collaboration with external teams is planned. Access to the constructed database is permitted by a partnership charter, which has been developed and already exhibited, mainly to potential partners, during communication concerning the cohort at the French Rheumatology Congress in 2008.","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":"12-09-2017","isContributorPI":"No","contributorName":"Francis GUILLEMIN","contributorAffiliation":"CENTRE HOSPITALIER REGIONAL ET UNIVERSITAIRE DE NANCY","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[{"type":"","title":"Liste des publications dans HAL","link":"http:\/\/www.hal.inserm.fr\/KHOALA"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Private non-profit","Public (France)","Public (France)","Public (France)","Public (France)","Industry"],"otherFundingAgentType":["","","","","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":"Yes"},"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: input from a paper questionnaire; Interviews: input from a paper questionnaire Clinical examinations: handwritten.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"Multicentric cohort throughout France (6 centres)"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"DNA, urine, serum samples","isDataInBiobank":"Yes","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}