{"doc_desc":{"title":"Etude longitudinale sur des patients atteints du syndrome de l\u2019Intestin Irritable : \"Suivi Epid\u00e9miologique et Co\u00fbts\"","idno":"FRESH-PEF8715-fr","producers":[{"name":"Jean-Marc SABATE","affiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF8715-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"8715"},{"agency":"FReSH","code":"FRESH-PEF8715"}]},"title":"Etude longitudinale sur des patients atteints du syndrome de l\u2019Intestin Irritable : \"Suivi Epid\u00e9miologique et Co\u00fbts\"","alternate_title":"SECSII"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Jean-Marc;SABATE","firstname":"Jean-Marc","lastname":"SABATE","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id"},{"title":"SIREN","uri":"267500452","role":"organisation id"}],"email":"jean-marc.sabate@aphp.fr","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","PILabo":"APHP \/ H\u00f4pital Louis MourierService d\u2019h\u00e9pato-gastroent\u00e9rologie","isContact":true}],"oth_id":[{"name":"projet europ\u00e9en E-cost ; GENIEUR (www.genieur.eu)","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"ASSOCIATION NATIONALE DES HEPATO-GASTROENTEROLOGUES DES HOPITAUX GENERAUX DE FRANCE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/0269vww35","role":"sponsor id"}],"role":"sponsor"},{"name":"ASS DES PATIENTS SOUFFRANTS DU SYNDROME DE L INTESTIN IRRITABLE (APSSII)","extlink":[{"title":"SIREN","uri":"533148680","role":"sponsor id"}],"role":"sponsor"},{"name":"GROUPE FRANCAIS DE NEURO-GASTRO-ENTEROLOGIE (GFNG)","extlink":[{"title":"SIREN","uri":"791608334","role":"sponsor id"}],"role":"sponsor"},{"name":"CLUB REFLEXION GROUPES DE GASTRO ENTEROL (CREGG)","extlink":[{"title":"SIREN","uri":"342104460","role":"sponsor id"}],"role":"sponsor"},{"name":"SOCIETE NATIONALE FRAN\u00c7AISE DE GASTRO-ENTEROLOGIE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/04c6sc363","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"SOCIETE NATIONALE FRAN\u00c7AISE DE GASTRO-ENTEROLOGIE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/04c6sc363"}]}]},"distribution_statement":{"contact":[{"name":"Jean-Marc;SABATE","lastname":"SABATE","firstname":"Jean-Marc","type":"contact","email":"jean-marc.sabate@aphp.fr","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id","title":"ROR"},{"uri":"267500452","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Syndrome de l'intestin irritable"},{"keyword":"douleurs abdominales"},{"keyword":"troubles du transit"},{"keyword":"co\u00fbts directs"},{"keyword":"co\u00fbts indirects"},{"keyword":"s\u00e9v\u00e9rit\u00e9."},{"keyword":"diagnostic"},{"keyword":"traitement"}],"topics":[{"topic":"Gastroent\u00e9rologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/a3898340-a42d-4f5e-a822-1de204a9a867"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D005762"}]},{"topic":"Syndrome de l'intestin irritable","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1158238623","title":"CIM-11"}]},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux : Alimentation","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"}],"purpose":"Le syndrome de l\u2019intestin irritable (SII) qui associe douleurs abdominales et troubles du transit, est une maladie fr\u00e9quente qui touche 5% de la population. On ne dispose pas de test diagnostique et les traitements utilis\u00e9s sont souvent peu efficaces. Le SII peut \u00eatre responsable d\u2019une alt\u00e9ration importante de la qualit\u00e9 de vie avec un retentissement sur les activit\u00e9s quotidiennes et le travail. Tous ces facteurs peuvent contribuer \u00e0 la multiplication des examens, des consultations et des traitements et donc au co\u00fbt global de la maladie, pour lequel en France on ne dispose pas de donn\u00e9es r\u00e9centes. Le but de cette cohorte est de d\u00e9crire en situation r\u00e9elle le co\u00fbt global du SII avec une \u00e9valuation des co\u00fbts directs (examens, consultations, hospitalisations, traitements rembours\u00e9s ou non, autom\u00e9dication, traitements alternatifs) et des co\u00fbts indirects (arr\u00eat de travail, perte de productivit\u00e9) en \u00e9valuant le r\u00f4le de facteurs li\u00e9s \u00e0 la maladie (type de SII, s\u00e9v\u00e9rit\u00e9, anciennet\u00e9 de la maladie) et du type de prise en charge (centres experts, h\u00f4pital, ville). Il s'agit donc d'une cohorte multicentrique fran\u00e7aise de patients avec SII pour r\u00e9alisation d\u2019analyses m\u00e9dico-\u00e9conomiques et \u00e9pid\u00e9miologiques (mieux conna\u00eetre les facteurs pronostiques d\u00e9mographiques, ant\u00e9c\u00e9dents, comorbidit\u00e9s, sympt\u00f4mes pr\u00e9dominants, type de prise en charge).","abstract":"","coll_dates":[{"start":"2014-01-01","end":"2018-01-01"}],"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    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \" Age 18 \u00e0 75 ans - Souffrant d\u2019un SII (crit\u00e8res de ROME III) - Explorations digestives normales (coloscopie totale et\\\/ou lavement baryt\u00e9 normal chez les sujets \u00e2g\u00e9s de 50 ans ou plus, rectosigmo\u00efdoscopie et\\\/ou lavement baryt\u00e9 normal chez les moins de 50 ans). Ces examens devront avoir \u00e9t\u00e9 effectu\u00e9s dans les 5 ans pr\u00e9c\u00e9dant l\u2019inclusion pour les patients de plus de 50 ans et sans limite de date pour les moins de 50 ans - Niveaux de compr\u00e9hension et d'expression satisfaisants en fran\u00e7ais - Acc\u00e8s \u00e0 internet ou accord pour envoi postal des questionnaires\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['monitoring en temps r\u00e9el avec ARC']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\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\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":""}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"< 500 individus","response_rate":"500"},"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":"","conditions":"Contacter le responsable scientifique","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":"28-04-2014","lastUpdatedAuto":null,"lastUpdatedManual":"11-05-2015","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Priv\u00e9 \u00e0 but non lucratif"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Priv\u00e9 \u00e0 but non lucratif","Priv\u00e9 \u00e0 but non lucratif","Priv\u00e9 \u00e0 but non lucratif","Priv\u00e9 \u00e0 but non lucratif","Priv\u00e9 \u00e0 but non lucratif"],"otherSponsorType":["","","","",""]},"governance":{"committee":""},"collaborations":{"networkConsortium":true},"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":"Le recueil des donn\u00e9es s\u2019effectue via un site internet s\u00e9curis\u00e9, d\u00e9di\u00e9, d\u00e9velopp\u00e9 sp\u00e9cifiquement pour cette \u00e9tude et agr\u00e9\u00e9 par la CNIL.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"France"},"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"}