{"doc_desc":{"title":"Cohorte de patients atteints d'arthrose de hanche et de genou (f\u00e9moro-tibiale)","idno":"FRESH-PEF60059-fr","producers":[{"name":"Francis GUILLEMIN","affiliation":"chu"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60059-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60059"},{"agency":"FReSH","code":"FRESH-PEF60059"}]},"title":"Cohorte de patients atteints d'arthrose de hanche et de genou (f\u00e9moro-tibiale)","alternate_title":"KHOALA: Knee and hip osteoarthritis long term assessment cohort"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CPP"}]},"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":"Oui"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (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":"proth\u00e8ses"},{"keyword":"qualit\u00e9 de vie"},{"keyword":"consommation de soins"}],"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":"Arthrose","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/558562409","title":"CIM-11"}]}],"purpose":"Objectif g\u00e9n\u00e9ral : D\u00e9crire l\u2019histoire naturelle des arthroses symptomatiques de hanche et de genou et identifier les facteurs pr\u00e9dictifs de leurs cons\u00e9quences en termes de douleur, d\u2019incapacit\u00e9 fonctionnelle, de qualit\u00e9 de vie et de consommation de soins (soins m\u00e9dicaux, utilisation des ressources de sant\u00e9 et co\u00fbt de la maladie) au moyen d\u2019une \u00e9tude de cohorte constitu\u00e9e \u00e0 partir des cas identifi\u00e9s lors d\u2019une \u00e9tude de pr\u00e9valence nationale. Objectifs secondaires : - \u00e9tudier les facteurs pr\u00e9dictifs de la qualit\u00e9 de vie et de son \u00e9volution et de la mise en place de proth\u00e8se totale de hanche ou de genou : param\u00e8tres socio-d\u00e9mographiques, cliniques, co-morbidit\u00e9s, param\u00e8tres de sant\u00e9 per\u00e7ue (qualit\u00e9 de vie, capacit\u00e9s fonctionnelles) \u00e0 l\u2019inclusion, radiographies, marqueurs biologiques ; - identifier les facteurs qui conditionnent les consommations de soins, les cons\u00e9quences sociales et de la prise en charge des arthroses symptomatiques de hanche et de genou ; - collecter et conserver des \u00e9chantillons biologiques (s\u00e9roth\u00e8que et dnath\u00e8que), des radiographies et des donn\u00e9es cliniques et de sant\u00e9 per\u00e7ue afin de constituer une plate-forme pour d\u2019autres projets de recherche, tels que des projets physiopathologiques sur les m\u00e9canismes cellulaires et mol\u00e9culaires de l\u2019arthrose et des projets g\u00e9n\u00e9tiques . La constitution de la cohorte b\u00e9n\u00e9ficiera des avantages de l\u2019\u00e9tude descriptive de pr\u00e9valence qui aura permis le recrutement d\u2019un \u00e9chantillon repr\u00e9sentatif de la population g\u00e9n\u00e9rale.","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":"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 (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\": \" Hommes ou femmes \u00e2g\u00e9s entre 40 ans et 75 ans - Arthrose de hanche et de genou (f\u00e9moro-tibiale), uni ou bilat\u00e9rale, symptomatique avec un diagnostic confirm\u00e9 et satisfaisant les crit\u00e8res de l\u2019ACR et de l\u2019Eular repr\u00e9sentatifs des cas pr\u00e9valents en France lors de la constitution de la cohorte\",\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 au moment de la saisie des donn\u00e9es informatiques et apr\u00e8s la saisie des donn\u00e9es informatiques.Gestion des donn\u00e9es manquantes par retour au dossier source ou vers le patientRelance des sujets pour r\u00e9aliser les visites de suivi R\u00e9alisation d\\'audits de qualit\u00e9 externes (bi-annuels)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\/morbidit\u00e9\r\nEv\u00e9nements de sant\u00e9\/mortalit\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":"878"},"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":"Utilisation possible des donn\u00e9es par des \u00e9quipes acad\u00e9miques Utilisation non possible des donn\u00e9es par des industriels.","conditions":"Condition d'acc\u00e8s: r\u00e9seaux collaboratif avec umr 7561 physiopathologie, pharmacologie et ing\u00e9nierie articulaires laboratoire de pharmacologie, vandoeuvre les nancy Une collaboration avec des \u00e9quipes ext\u00e9rieures est pr\u00e9vue. Une charte de partenariat permettant l\u2019acc\u00e8s \u00e0 la base de donn\u00e9es constitu\u00e9e, a \u00e9t\u00e9 \u00e9labor\u00e9e et d\u00e9j\u00e0 expos\u00e9e, notamment \u00e0 des partenaires potentiels, lors de la communication autour de la cohorte au congr\u00e8s fran\u00e7ais de rhumatologie 2008.","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":"12-09-2017","isContributorPI":"Non","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":["Priv\u00e9 \u00e0 but non lucratif","Public (France)","Public (France)","Public (France)","Public (France)","Industrie"],"otherFundingAgentType":["","","","","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":"Oui"},"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 papierEntretiens : saisie \u00e0 partir d\u2019un questionnaire papier Examens cliniques : saisie manuelle","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Cohorte multicentrique (6 centres) fran\u00e7aise"},"dataTypes":{"clinicalDataDetails":"Examen clinique \u00e0 l\u2019inclusion et au cours du suivi tous les 6 mois.Informations recueillies lors de l'examen clinique : score algofonctionnel HSS pour le genou et score de Harris pour la hanche","biologicalDataDetails":"Pr\u00e9l\u00e8vements s\u00e9rique, urinaire, ADN","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}