{"doc_desc":{"title":"Etude observationnelle prospective sur la QuALit\u00e9 de vie des patients atteints d\u2019Infection \u00e0 clostridium diFFicile","idno":"FRESH-PEF73339-fr","producers":[{"name":"Laurie LEVY-BACHELOT","affiliation":"MSD FRANCE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73339-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73339"},{"agency":"FReSH","code":"FRESH-PEF73339"}]},"title":"Etude observationnelle prospective sur la QuALit\u00e9 de vie des patients atteints d\u2019Infection \u00e0 clostridium diFFicile","alternate_title":"QALIFF"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Laurie;LEVY-BACHELOT","firstname":"Laurie","lastname":"LEVY-BACHELOT","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00kt5kp12","role":"organisation id"},{"title":"SIREN","uri":"417890589","role":"organisation id"}],"email":"laurie.levy-bachelot@msd.com","affiliationName":"MSD FRANCE","PILabo":"MSD","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"MSD FRANCE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00kt5kp12","role":"sponsor id"},{"title":"SIREN","uri":"417890589","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"MSD FRANCE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00kt5kp12"},{"title":"SIREN","uri":"417890589"}]}]},"distribution_statement":{"contact":[{"name":"Laurie;LEVY-BACHELOT","lastname":"LEVY-BACHELOT","firstname":"Laurie","type":"contact","email":"laurie.levy-bachelot@msd.com","affiliationName":"MSD FRANCE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00kt5kp12","role":"organisation id","title":"ROR"},{"uri":"417890589","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"infection \u00e0 Clostridium Difficile"},{"keyword":"qualit\u00e9 de vie"}],"topics":[{"topic":"Infectiologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/fa2ceeab-3b2f-45e9-9243-e5a8005b98de"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D055552"}]},{"topic":"Maladies de l'appareil digestif","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1256772020","title":"CIM-11"}]},{"topic":"Autre","vocab":"health determinant"}],"purpose":"Evaluer les cons\u00e9quences d\u2019une ICD sur la qualit\u00e9 de vie des patients \u00e0 travers l\u2019\u00e9volution du profil EQ5D avant\/pendant l\u2019\u00e9pisode","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\": \"Crit\u00e8res d\u2019inclusion \uf0b7 Patient adulte pr\u00e9sentant une ICD, quel que soit le motif de son hospitalisation, \uf0b7 Patient ayant donn\u00e9 son consentement \u00e9clair\u00e9. \",\n    \"clusion_E\": \"\uf0b7 Patient ayant moins de 18 ans \uf0b7 Patient ne disposant pas d\u2019un t\u00e9l\u00e9phone \uf0b7 Patient incapable de r\u00e9pondre au questionnaire (barri\u00e8re de langue, d\u00e9ficits cognitifs) \uf0b7 Patient refusant de participer \uf0b7 Patient souffrant de MICI (Maladie Inflammatoire Chronique de l'Intestin) \uf0b7 Patient inclus dans un essai clinique th\u00e9rapeutique au moment de l\u2019\u00e9tude\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude','Donn\u00e9es socio-d\u00e9mographiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[]},"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\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Pas d\u2019acc\u00e8s","sources":[],"target_sample_size":"< 500 individus","response_rate":"250 patients th\u00e9oriques"},"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\":\"A d\u00e9finir\",\"extLink\":[]}"},"dataset_use":{"restrictions":"","conditions":"","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":"18-07-2016","lastUpdatedAuto":null,"lastUpdatedManual":"07-09-2020","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industrie"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Industrie"],"otherSponsorType":[""]},"governance":{"committee":true},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":true,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"lieu d'hospitalisation"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}