{"doc_desc":{"title":"Observatoire de la m\u00e9decine g\u00e9n\u00e9rale - Etude longitudinale sur des patients consultant leur m\u00e9decin traitant","idno":"FRESH-PEF60171-fr","producers":[{"name":"Pascal CLERC","affiliation":"UNIVERSITE PARIS CITE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60171-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60171"},{"agency":"FReSH","code":"FRESH-PEF60171"}]},"title":"Observatoire de la m\u00e9decine g\u00e9n\u00e9rale - Etude longitudinale sur des patients consultant leur m\u00e9decin traitant","alternate_title":"OMG"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Pascal;CLERC","PILabo":"SOCI\u00c9T\u00c9 FRAN\u00c7AISE DE M\u00c9DECINE \/ CERMES (INSERM CNRS U750)","affiliationName":"UNIVERSITE PARIS CITE","extlink":[{"title":"ORCID","uri":"0000-0002-9290-081X","role":"pi id"},{"title":"IdRef","uri":"116850108","role":"pi id"},{"title":"SIREN","uri":"130025737","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"pascal.clerc@u-cergy.fr","isContact":"Oui"}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":""}],"funding_agencies":[{"name":"GIS-INSTITUT POUR LA RECHERCHE EN SANTE PUBLIQUE (IRESP)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/05fw72335"}]},{"name":"","extlink":[]},{"name":"","extlink":[]}]},"distribution_statement":{"contact":[{"name":"Pascal;CLERC","email":"pascal.clerc@u-cergy.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"}]}]},"study_info":{"keywords":[{"keyword":"patient"},{"keyword":"m\u00e9decin traitant"},{"keyword":"caract\u00e9ristiques socio-d\u00e9mographiques"},{"keyword":"biom\u00e9trie"},{"keyword":"d\u00e9cisions"},{"keyword":"prescriptions m\u00e9dicamenteuses"},{"keyword":"r\u00e9sultats de consultation"},{"keyword":"\u00e9v\u00e9nements de sant\u00e9"},{"keyword":"diagnostic"},{"keyword":"syst\u00e8me de sant\u00e9"}],"topics":[{"topic":"M\u00e9decine g\u00e9n\u00e9rale","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/4b9f8efb-68dd-45a1-b04c-d23d457d6898"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D058006"}]}],"purpose":"Objectif g\u00e9n\u00e9ral : Produire des donn\u00e9es sur les pathologies rencontr\u00e9es et les soins apport\u00e9s aux patients en m\u00e9decine de premiers recours, pour les acteurs du syst\u00e8me de sant\u00e9, les acteurs de la recherche en sant\u00e9 publique, en \u00e9conomie de la sant\u00e9 ou sur les services de sant\u00e9. Objectifs secondaires : - Produire des donn\u00e9es \u00e9pid\u00e9miologiques sur les besoins de la population g\u00e9n\u00e9rale et ses d\u00e9terminants : caract\u00e9ristiques des patients, diagnostics et prises en charge - Participer \u00e0 des recherches visant \u00e0 am\u00e9liorer la connaissance sur l'efficacite, l\u2019efficience, et l\u2019\u00e9quit\u00e9 des pratiques m\u00e9dicales et des organisations de d\u00e9livrance des soins","abstract":"","coll_dates":[{"start":"1994-01-01","end":"2011-01-01"}],"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\": \"Nouveau-n\u00e9 (naissance \u00e0 28j)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007231\"\n            }\n        },\n        {\n            \"value\": \"Enfance (6 \u00e0 12 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        },\n        {\n            \"value\": \"Adolescence (13 \u00e0 18 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000293\"\n            }\n        },\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\": \"Signature du formulaire m\u00e9decin traitant pour les patients de plus de 16 ans chez investigateurs participant \u00e0 l'OMG.  Pour les patients de moins de 16 ans marquage des enfants suivi par les m\u00e9decins investigateurs.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es biologiques']","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 suiviAutre(s) proc\u00e9dure(s) qualit\u00e9 : - Comparaison des volumes de s\u00e9ances recueillis au RIAP du m\u00e9decin investigateur - tests de coh\u00e9rence des fr\u00e9quences des diagnostics et d\u00e9cisions par rapport au groupe - Enqu\u00eate sur la variabilit\u00e9 du codage 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 les professionnels d'exercice lib\u00e9ral']"}},"coll_mode":["{\"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":">= 20000 individus","response_rate":"100 000"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"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 - appariement des donn\u00e9es avec les donn\u00e9es de l'assurance maladie dans le cadre d'\u00e9quipe \u00e9mergente prospere \/ acc\u00e8s aux donn\u00e9es possible dans un cadre fix\u00e9 par le comit\u00e9 scientifique et de pilotage","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":"30-07-2014","isContributorPI":"Non","contributorName":"Pascal CLERC","contributorAffiliation":"UNIVERSITE PARIS CITE","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"Liste des publications dans Pubmed","link":"http:\/\/tinyurl.com\/Pubmed-Etude-OMG"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Industrie","Priv\u00e9 \u00e0 but non lucratif"],"otherFundingAgentType":["","",""]},"sponsor":{"sponsorType":[],"otherSponsorType":[]},"governance":{"committee":""},"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":"Entretiens : Saisie directe Examens cliniques : Saisie directe Examens biologiques : Saisie directe","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"200 centres en France"},"dataTypes":{"clinicalDataDetails":"Examen clinique au cours du suivi selon le rythme des consultations du patient Informations recueillies lors de l'examen clinique : Le nombre de s\u00e9ances par an est en moyenne 3 par an dans lesquels sont recueillis : biom\u00e9trie, diagnostics, d\u00e9cisons","biologicalDataDetails":"Type de pr\u00e9l\u00e8vements r\u00e9alis\u00e9s : biologie prescrite dans le cadre du diagnostic ou du suivi des pathologies des patients inclus dans la cohorte avec saisie des r\u00e9sultats dans des champs pr\u00e9d\u00e9finis pour les principales valeurs","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}