{"doc_desc":{"title":"Etude observationnelle d\u2019\u00e9valuation de l\u2019utilit\u00e9 clinique du questionnaire OPTIMA en pratique courante","idno":"FRESH-PEF73346-fr","producers":[{"name":"Laurie LEVY-BACHELOT","affiliation":"MSD FRANCE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73346-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73346"},{"agency":"FReSH","code":"FRESH-PEF73346"}]},"title":"Etude observationnelle d\u2019\u00e9valuation de l\u2019utilit\u00e9 clinique du questionnaire OPTIMA en pratique courante","alternate_title":"OPTIMA"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Christine;MOISAN","firstname":"Christine","lastname":"MOISAN","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00kt5kp12","role":"organisation id"},{"title":"SIREN","uri":"417890589","role":"organisation id"}],"email":"","affiliationName":"MSD 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de l\u2019\u00e9tude est: \u2022 L\u2019\u00e9valuation du taux de consultations qui se terminent par la mise en place d\u2019un micro-objectif par le m\u00e9decin et le patient, en utilisant comme support le questionnaire OPTIMA.","abstract":"","coll_dates":[{"start":"","end":""}],"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\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Inclusion :  Patient(e) homme ou femme \u00e2g\u00e9(e) de 35 ans et plus \u2022Patient(e) diagnostiqu\u00e9(e) avec un diab\u00e8te de type 2, HbA1c compris entre 7 et 9.5% et n\u2019ayant pas atteint l\u2019objectif d\u2019HbA1c fix\u00e9 avec son m\u00e9decin  \u2022Patient(e) trait\u00e9(e) par antidiab\u00e9tique(s) oral(ux) depuis au moins 1 an, sans analogues GLP-1, sans insuline \u2022Patient(e) n\u2019ayant pas d\u00e9j\u00e0 \u00e9t\u00e9 trait\u00e9 par insuline ou analogues du GLP1 \u2022Patient(e) venant consulter ce jour pour son diab\u00e8te de type 2 \u2022Patient(e) ayant les aptitudes physiques, mentales et linguistiques n\u00e9cessaires \u00e0 la compr\u00e9hension et au remplissage de questionnaires \u2022Patient(e) ayant accept\u00e9 oralement de participer \u00e0 l\u2019\u00e9tude et de remplir un questionnaire  En plus, pour les patients remplissant le module \u00ab Mesure de la glyc\u00e9mie \u00bb : \u2022Patient(e) utilisant un lecteur de glyc\u00e9mie  \",\n    \"clusion_E\": \"\u2022Patient(e) diab\u00e9tique de type 1 \u2022Patient(e) diab\u00e9tique de type 2 insulino-trait\u00e9 \u2022Femme non diab\u00e9tique de type 2 ayant d\u00e9velopp\u00e9 un diab\u00e8te gestationnel \u2022Femme enceinte ou pr\u00e9voyant de l\u2019\u00eatre  \u2022Patient(e) atteint(e) d\u2019une pathologie affectant le pronostic vital \u00e0 court terme (6 mois) \u2022Patient(e) ayant un probl\u00e8me psychiatrique s\u00e9v\u00e8re, ou un autre probl\u00e8me m\u00e9dical significatif ou des r\u00e9sultats anormaux \u00e0 des tests de laboratoire qui pourraient compromettre sa participation \u00e0 l\u2019\u00e9tude \u2022Patient(e) atteint(e) d\u2019autres maladies chroniques invalidantes en dehors des complications li\u00e9es au diab\u00e8te (asthme, polyarthrite rhumato\u00efde, d\u00e9pression grave, etc\u2026) \u2022Patient(e) participant actuellement \u00e0 un essai clinique \u2022Ev\u00e9nements intercurrents importants, survenus dans les 3 derniers mois, ayant pu perturber la vie du patient d\u2019un point de vue psychologique, somatique ou mat\u00e9riel  \"\n}","data_kind":"['Donn\u00e9es rapport\u00e9es par le participant de 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