{"doc_desc":{"title":"Cohorte des consultants des centres d'examens de sant\u00e9","idno":"FRESH-PEF3395-fr","producers":[{"name":"Marie ZINS","affiliation":"UNIVERSITE PARIS CITE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF3395-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"3395"},{"agency":"FReSH","code":"FRESH-PEF3395"}]},"title":"Cohorte des consultants des centres d'examens de sant\u00e9","alternate_title":"CONSTANCES"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Marie;ZINS","PILabo":"INSERM Universit\u00e9 de Paris, Paris Saclay, UVSQ \/ UMS 011 Cohortes \u00e9pid\u00e9miologiques en population","affiliationName":"UNIVERSITE PARIS CITE","extlink":[{"title":"ORCID","uri":"0000-0002-4540-4282","role":"pi id"},{"title":"IdRef","uri":"074613324","role":"pi id"},{"title":"SIREN","uri":"130025737","role":"organisation id"},{"title":"RNSR","uri":"201322808P","role":"labo id"}],"email":"marie.zins@inserm.fr","isContact":"Oui"},{"type":"investigator","name":"Marcel;GOLDBERG","PILabo":"UMS 011 Cohortes \u00e9pid\u00e9miologiques en population","affiliationName":"UNIVERSITE PARIS-SACLAY","extlink":[{"title":"ORCID","uri":"0000-0002-6161-5880","role":"pi id"},{"title":"IdRef","uri":"028740637","role":"pi id"},{"title":"SIREN","uri":"130026024","role":"organisation id"},{"title":"RNSR","uri":"201322808P","role":"labo id"}],"email":"marcel.goldberg@inserm.fr","isContact":"Oui"}],"oth_id":[{"name":"OMEGA-COST H2020, Longitool H2020, EPHOR H2020, BBMRI-LPC, IDEAR, P3G, LIFEPAPH H2020,","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"UNIVERSITE PARIS CITE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/05f82e368","role":"sponsor id"},{"title":"SIREN","uri":"130025737","role":"sponsor id"}],"role":"sponsor"},{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"sponsor id"},{"title":"SIREN","uri":"180036048","role":"sponsor id"}],"role":"sponsor"},{"name":"UNIVERSITE PARIS-SACLAY","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03xjwb503","role":"sponsor id"},{"title":"SIREN","uri":"130026024","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":""}]},"distribution_statement":{"contact":[{"name":"Marie;ZINS","email":"marie.zins@inserm.fr","type":"contact","affiliationName":"UNIVERSITE PARIS CITE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/05f82e368","role":"organisation id","title":"ROR"},{"uri":"130025737","role":"organisation id","title":"SIREN"}]},{"name":"Marcel;GOLDBERG","email":"marcel.goldberg@inserm.fr","type":"contact","affiliationName":"UNIVERSITE PARIS-SACLAY","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/03xjwb503","role":"organisation id","title":"ROR"},{"uri":"130026024","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"centre d'examen de sant\u00e9"},{"keyword":"indicateurs de sant\u00e9 publique"},{"keyword":"\u00e9chantillon repr\u00e9sentatif"},{"keyword":"population adulte"},{"keyword":"sant\u00e9 des femmes"},{"keyword":"Cohorte g\u00e9n\u00e9raliste"},{"keyword":"maladies chroniques"},{"keyword":"environnement"},{"keyword":"vieillissement"},{"keyword":"risques professionnels"},{"keyword":"comportements"}],"topics":[{"topic":"COVID-19","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1730556128","title":"CIM-11"}]},{"topic":"D\u00e9terminants comportementaux : Addictions","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux : Climat","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques : Pr\u00e9dispositions g\u00e9n\u00e9tiques","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux : Autres","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux : Alimentation","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux","vocab":"health determinant"},{"topic":"Syst\u00e8mes de soins et acc\u00e8s aux soins","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques : Emploi","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"L\u2019objectif est de mettre en \u0153uvre une importante cohorte \u00e9pid\u00e9miologique, repr\u00e9sentative de la population g\u00e9n\u00e9rale adulte et d\u2019effectif important, destin\u00e9e \u00e0 contribuer au d\u00e9veloppement de la recherche \u00e9pid\u00e9miologique et \u00e0 fournir des informations \u00e0 vis\u00e9e de sant\u00e9 publique. - C'est une infrastructure pour la recherche \u00e9pid\u00e9miologique, par son effectif, la qualit\u00e9 et la diversit\u00e9 des donn\u00e9es, les modalit\u00e9s de suivi. Les objectifs sont centr\u00e9s sur l'\u00e9pid\u00e9miologie des maladies chroniques, du vieillissement, des comportements, de l'environnement et des d\u00e9terminants professionnels et sociaux de la sant\u00e9. Elle doit \u00e9galement permettre la r\u00e9alisation de projets concernant des th\u00e8mes vari\u00e9s, gr\u00e2ce \u00e0 un acc\u00e8s largement ouvert \u00e0 la communaut\u00e9 des chercheurs. - C'est un outil pour la sant\u00e9 publique, venant en appui des objectifs de sant\u00e9 publique de la CNAMTS et de l\u2019\u00c9tat, et de l\u2019\u00e9valuation de leur atteinte, par le caract\u00e8re particuli\u00e8rement complet du dispositif de suivi et de recueil d\u2019informations tr\u00e8s diversifi\u00e9es, gr\u00e2ce \u00e0 des m\u00e9thodes diverses et compl\u00e9mentaires faisant appel \u00e0 plusieurs sources de donn\u00e9es. - C'est un outil pour la surveillance \u00e9pid\u00e9miologique, \u00e0 travers un partenariat \u00e9tabli avec Sant\u00e9 publique France (notamment autour des th\u00e9matiques risques professionnels, environnement et maladies chronique).","abstract":"","coll_dates":[{"start":"2012-01-01","end":"2021-01-01"}],"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            \"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            \"value\": \"Grand \u00e2ge (80 ans et plus)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Population g\u00e9n\u00e9rale\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Adultes \u00e2g\u00e9s de 18 \u00e0 69 ans, affili\u00e9s au R\u00e9gime g\u00e9n\u00e9ral de S\u00e9curit\u00e9 sociale comprenant les affili\u00e9s aux SLM.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude','Donn\u00e9es paracliniques','Donn\u00e9es biologiques','Donn\u00e9es socio-d\u00e9mographiques','Donn\u00e9es paracliniques (hors biologiques) : Anthropom\u00e9trie','Donn\u00e9es paracliniques (hors biologiques) : Exploration fonctionnelle','Donn\u00e9es paracliniques (hors biologiques) : Autre']","quality_statement":{"standards":[{"name":"['NAF PCS pour les calendrier professionnels, passerelle vers des nomenclature europ\u00e9ennes']","committee":"","governance":""}],"other_quality_statement":"['monitorage sur site pour les examens de sant\u00e9 plus plan de validation, suivi mat\u00e9riel standardis\u00e9,\u00e9talonnage, plan de nettoyage des questionnaires']"}},"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\r\nConsommation de soins\/services de sant\u00e9\r\nQualit\u00e9 de vie\/sant\u00e9 per\u00e7ue"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Probability.Stratified\",\"vocab\":\"CESSDA\"},\"value\":\"Probabiliste : stratifi\u00e9\"}']","sample_frame":{"frame_unit":{"unit_type":"['Base m\u00e9dico-administrative (de patients, Assurance Maladie\/Mutuelle)']"}},"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":[{"sourceCitation":{"titlStmt":{"titl":""},"holdings":"","notes":{"subject":"source purpose","value":""}},"srcOrig":["Base m\u00e9dico-administrative"]}],"target_sample_size":">= 20000 individus","response_rate":"215.000"},"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":"Sur appel \u00e0 projets s\u00e9lectionn\u00e9s par le Conseil scientifique voir sur le site : https:\/\/www.constances.fr\/espace-scientifique\/proposer-projet.php","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":"11-04-2012","lastUpdatedAuto":null,"lastUpdatedManual":"21-12-2020","isContributorPI":"Non","contributorName":"Marie ZINS","contributorAffiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.hal.inserm.fr\/CONSTANCES"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":[],"otherFundingAgentType":[]},"sponsor":{"sponsorType":["Public (France)","Public (France)","Public (France)"],"otherSponsorType":["","",""]},"governance":{"committee":"Oui"},"collaborations":{"networkConsortium":"Oui"},"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":"- A l'inclusion: Auto-questionnaire \u00e0 compl\u00e9ter \u00e0 domicile + examen de sant\u00e9 p\u00e9riodique (EPS) dans un CES permettant de recueillir donn\u00e9es de sant\u00e9 (clinique, paraclinique) et questionnaires compl\u00e9mentaires (expositions professionnelle vie enti\u00e8re, auto-questionnaire \u00e0 remplir au CES pour les femmes) - Suivi actif: un autoquestionnaire postal envoy\u00e9 chaque ann\u00e9e au domicile des sujets ; une invitation \u00e0 venir au CES tous les 5 ans est pr\u00e9vue pour l\u2019ensemble des sujets de la cohorte.- Suivi passif d\u2019\u00e9v\u00e9nement socioprofessionnels et de donn\u00e9es de sant\u00e9 : les principaux \u00e9v\u00e9nements socioprofessionnels sont r\u00e9guli\u00e8rement extraits des bases de donn\u00e9es de la Cnav (D\u00e9clarations Annuelles des Donn\u00e9es Sociales, Donn\u00e9es Nominatives Trimestrielles, ch\u00f4mage, absences pour maladie, RMI, maternit\u00e9). Les donn\u00e9es de sant\u00e9 concernent le statut vital et les causes de d\u00e9c\u00e8s par l\u2019acc\u00e8s au r\u00e9pertoire national d'identification des personnes physiques (RNIPP) et \u00e0 la base de donn\u00e9es du C\u00e9piDc-Inserm ; les principaux \u00e9v\u00e9nements de sant\u00e9 sont extraits du Syst\u00e8me national d\u2019information inter r\u00e9gimes de l\u2019assurance maladie (SNIIR-AM) : donn\u00e9es de remboursement, Affections de longue dur\u00e9e (ALD), et pour chacun des s\u00e9jours hospitaliers : diagnostic principal et diagnostics associ\u00e9s, actes diagnostiques et th\u00e9rapeutiques .","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Oui"},"geographicalCoverage":{"geoDetail":"Au moment de 'inclusion : les participants r\u00e9sident dans 16 puis 20 d\u00e9partements m\u00e9tropolitains depuis 2015. les volontaires continuent d'\u00eatre suivi en cas de d\u00e9m\u00e9nagement"},"dataTypes":{"clinicalDataDetails":"Examen dans un Centre d'examens de sant\u00e9 Retour au dossier clinique pour validation de cas incidents","biologicalDataDetails":"Glyc\u00e9mie \u00e0 jeun, bilan lipidique, bilan h\u00e9patique, cr\u00e9atin\u00e9mie, num\u00e9ration formule sanguine, examen urinaire.","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[""]},"isHealthTheme":"Non","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}