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        <titl xml:lang="FR">Etude longitudinale sur des patients atteints d'une maladie de Crohn sévère et évolutive n'ayant pas répondu aux traitements et initiant un traitement par anti-TN alpha</titl>
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        <altTitl xml:lang="FR">VISION</altTitl>
        <altTitl xml:lang="EN">VISION</altTitl>
        <parTitl xml:lang="EN">Longitudinal study on patients with severe Crohn's disease that did not respond to treatment and who are initiating treatment with anti-TNF alpha</parTitl>
        <IDNo>PEF98</IDNo>
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        <AuthEnty affiliation="ITMO Santé Publique, Aviesan">Portail Épidémiologie-France</AuthEnty>
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        <producer abbr="PEF-HD" affiliation="ITMO Santé Publique, Aviesan">Portail Épidémiologie-France | Health Databases</producer>
        <copyright>Portail Épidémiologie-France 2026</copyright>
        <prodDate date="2026-04-04">04/04/2026</prodDate>
        <prodPlac>https://epidemiologie-france.aviesan.fr/</prodPlac>
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        <distrbtr>Portail Épidémiologie-France</distrbtr>
        <contact email="portail-epidemiologie@inserm.fr">Portail Epidemiologie-France</contact>
        <depositr>Emmanuel Thibout</depositr>
        <depDate xml:lang="FR">14/12/2010</depDate>
        <depDate xml:lang="EN">07/02/2012</depDate>
        <distDate>14/12/2010</distDate>
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        <version xml:lang="EN" date="02/04/2012">2</version>
        <verResp>Emmanuel Thibout</verResp>
        <notes/>
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      <biblCit/>
      <holdings xml:lang="FR" location="Portail Epidemiologie-France" URI="http://epidemiologie-france.aviesan.fr/layout/set/print/content/view/full/84642">VISION - Etude longitudinale sur des patients atteints d'une maladie de Crohn sévère et évolutive n'ayant pas répondu aux traitements et initiant un traitement par anti-TN alpha</holdings>
      <holdings xml:lang="EN" location="Portail Epidemiologie-France" URI="http://epidemiologie-france.aviesan.fr/layout/set/print/content/view/full/84643">VISION - Longitudinal study on patients with severe Crohn's disease that did not respond to treatment and who are initiating treatment with anti-TNF alpha</holdings>
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    <citation>
      <titlStmt>
        <titl xml:lang="FR">Etude longitudinale sur des patients atteints d'une maladie de Crohn sévère et évolutive n'ayant pas répondu aux traitements et initiant un traitement par anti-TN alpha</titl>
        <subTitl/>
        <altTitl xml:lang="FR">VISION</altTitl>
        <altTitl xml:lang="EN">VISION</altTitl>
        <parTitl xml:lang="EN">Longitudinal study on patients with severe Crohn's disease that did not respond to treatment and who are initiating treatment with anti-TNF alpha</parTitl>
        <IDNo/>
      </titlStmt>
      <rspStmt>
        <AuthEnty affiliation="">Emmanuel Thibout</AuthEnty>
      </rspStmt>
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        <producer role="Secteur Privé">Abbott France</producer>
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        <prodPlac> -  - </prodPlac>
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        <fundAg xml:lang="EN" role="Private">Abbott France</fundAg>
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        <contact affiliation="" email="emmanuel.thibout@abbott.com">Emmanuel Thibout</contact>
        <depositr>Emmanuel Thibout</depositr>
        <depDate xml:lang="FR">14/12/2010</depDate>
        <depDate xml:lang="EN">07/02/2012</depDate>
        <distDate xml:lang="FR">14/12/2010</distDate>
        <distDate xml:lang="EN">02/04/2012</distDate>
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        <serName/>
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        <version xml:lang="FR" date="14/12/2010">2</version>
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        <verResp>Emmanuel Thibout</verResp>
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    <studyAuthorization>
      <authorizingAgency>CNIL</authorizingAgency>
      <authorizationStatement xml:lang="FR">CNIL n°1379382</authorizationStatement>
      <authorizationStatement xml:lang="EN">CNIL n°1379382</authorizationStatement>
    </studyAuthorization>
    <stdyInfo>
      <studyBudget/>
      <subject>
        <keyword xml:lang="FR">validation psychométrique</keyword>
        <keyword xml:lang="FR">questionnaire</keyword>
        <keyword xml:lang="FR">satisfaction</keyword>
        <keyword xml:lang="FR">patients</keyword>
        <keyword xml:lang="FR">anti-TNF alpha</keyword>
        <keyword xml:lang="EN">psychometric validation</keyword>
        <keyword xml:lang="EN">questionnaire</keyword>
        <keyword xml:lang="EN">satisfaction</keyword>
        <keyword xml:lang="EN">patients</keyword>
        <keyword xml:lang="EN">anti-TNF alpha</keyword>
        <topcClas xml:lang="FR">Gastro-entérologie et hépatologie</topcClas>
        <topcClas xml:lang="EN">Gastroenterology et hepatology</topcClas>
        <topcClas xml:lang="FR"/>
        <topcClas xml:lang="EN"/>
      </subject>
      <abstract xml:lang="FR">Objectif de la base de données : Valider un nouveau questionnaire de satisfaction des patients vis à vis de leur traitement par Anti TNF dans la maladie de Crohn à un stade sévère et évolutif</abstract>
      <abstract xml:lang="EN">Database objective : Validate a new satisfaction questionnaire for patients with regards to their treatment with Anti TNF in Crohn's disease at a severe and evolving stage</abstract>
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        <timePrd/>
        <collDate event="start">2010</collDate>
        <collDate event="end">2011</collDate>
        <collDate xml:lang="FR">Collecte des données active</collDate>
        <collDate xml:lang="EN">Current data collection</collDate>
        <nation>France</nation>
        <geogCover xml:lang="FR">France</geogCover>
        <geogCover xml:lang="EN">National</geogCover>
        <geogUnit>National</geogUnit>
        <anlyUnit xml:lang="fr">individuel
                </anlyUnit>
        <anlyUnit xml:lang="en">individuals
                </anlyUnit>
        <universe xml:lang="FR" clusion="I">Patients atteints d'une maladie de Crohn sévère et évolutive et n'ayant pas répondu aux traitements malgré un protocole complet et adapté de corticothérapie et/ou d'un immunosupresseur ou intolérants à de tels traitements ou présentant des contre-indications médicales et qui passe à un traitement anti TNF</universe>
        <universe xml:lang="EN" clusion="I">Patients suffering from severe and evolving Crohn's disease and who have not responded to the treatments despite a complete and adapted protocol of corticotherapy and/or an immunosuppressant or intolerant to such treatments or that have medical contraindications and who move to an anti TNF treatment</universe>
        <universe xml:lang="FR">Nombre d'individus : 300</universe>
        <universe xml:lang="EN">Number of individuals: 300</universe>
        <universe xml:lang="FR">Recrutement via une sélection de services ou établissements de santé</universe>
        <universe xml:lang="EN">Recruiting through a selection of health institutions and services</universe>
        <universe xml:lang="FR">sur la base Prise de produit(s) de santé</universe>
        <universe xml:lang="EN">based on Medication(s) taken</universe>
        <universe xml:lang="FR" level="Tranche d'âge">Adulte (19 à 24 ans)</universe>
        <universe xml:lang="FR" level="Tranche d'âge">Adulte (25 à 44 ans)</universe>
        <universe xml:lang="FR" level="Tranche d'âge">Adulte (45 à 64 ans)</universe>
        <universe xml:lang="EN" level="Age range">Adulthood (19 to 24 years)</universe>
        <universe xml:lang="EN" level="Age range">Adulthood (25 to 44 years)</universe>
        <universe xml:lang="EN" level="Age range">Adulthood (45 to 64 years)</universe>
        <universe xml:lang="FR" level="Type de population">Sujets malades</universe>
        <universe xml:lang="EN" level="Population type">Sick population</universe>
        <universe xml:lang="FR" level="Sexe">Masculin</universe>
        <universe xml:lang="FR" level="Sexe">Féminin</universe>
        <universe xml:lang="EN" level="Sex">Male</universe>
        <universe xml:lang="EN" level="Sex">Female</universe>
        <dataKind xml:lang="FR">Bases de données issues d’enquêtes</dataKind>
        <dataKind xml:lang="EN">Study databases</dataKind>
        <dataKind xml:lang="FR">Etudes longitudinales (hors cohortes)</dataKind>
        <dataKind xml:lang="EN">Longitudinal study (except cohorts)</dataKind>
        <dataKind xml:lang="FR">Données cliniques : </dataKind>
        <dataKind xml:lang="FR">Données déclaratives : Auto-questionnaire papier</dataKind>
        <dataKind xml:lang="EN">Clinical data: </dataKind>
        <dataKind xml:lang="EN">Declarative data: Paper self-questionnaire</dataKind>
        <dataKind xml:lang="FR">Autres</dataKind>
        <dataKind xml:lang="EN">Others</dataKind>
        <dataKind xml:lang="FR"/>
        <dataKind xml:lang="EN"/>
        <dataKind xml:lang="FR">Questionnaire de satisfaction</dataKind>
        <dataKind xml:lang="EN">Satisfaction questionnaire</dataKind>
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      <qualityStatement>
        <standardsCompliance>
          <standard>
            <standardName xml:lang="FR">CIM 10</standardName>
            <standardName xml:lang="EN">CIM 10</standardName>
            <producer/>
          </standard>
          <complianceDescription/>
        </standardsCompliance>
        <otherQualityStatement xml:lang="FR"/>
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        <otherQualityStatement xml:lang="FR"/>
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        <description/>
        <participant/>
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          <dataSrc/>
          <dataSrc/>
          <dataSrc/>
          <dataSrc/>
          <srcOrig/>
          <srcChar/>
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        <outcome/>
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      <dataColl>
        <timeMeth method="http://www.ddialliance.org/Specification/DDI-CV/TimeMethod_1.2_Genericode1.0_DDI-CVProfile1.0.xml">Time Series</timeMeth>
        <dataCollector affiliation="">Emmanuel Thibout</dataCollector>
        <collectorTraining/>
        <frequenc xml:lang="FR">3 mois de suivi à partir de l'inclusion du patient</frequenc>
        <frequenc xml:lang="EN">3 months of follow-up starting from patient inclusion</frequenc>
        <sampProc xml:lang="FR">Tirage au sort de 30 gastro-entérologues parmi une liste de gastro-entérologues français qui suivent et traitent des patients pour leur maladie de Crohn</sampProc>
        <sampProc xml:lang="EN">Random selection of 30 gastroenterologists from a list of French gastroenterologists who follow and treat patients for their Crohn's disease</sampProc>
        <deviat/>
        <collMode xml:lang="FR">Dossier clinique : </collMode>
        <collMode xml:lang="EN">Direct physical measures: </collMode>
        <collMode xml:lang="FR">Auto-questionnaire papier : </collMode>
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        <origArch/>
        <avlStatus xml:lang="FR">Publications</avlStatus>
        <avlStatus xml:lang="EN">Publications</avlStatus>
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        <complete/>
        <fileQnty/>
        <notes/>
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        <restrctn xml:lang="FR">Publications</restrctn>
        <restrctn xml:lang="EN">Publications</restrctn>
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        <deposReq/>
        <conditions xml:lang="FR">Publications</conditions>
        <conditions xml:lang="EN">Publications</conditions>
        <disclaimer/>
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      <notes/>
    </dataAccs>
    <othrStdyMat>
      <relMat xml:lang="FR">non</relMat>
      <relMat xml:lang="FR">non</relMat>
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      <relPubl xml:lang="FR">http://tinyurl.com/Pubmed-VISION</relPubl>
      <relPubl xml:lang="EN">http://tinyurl.com/Pubmed-VISION</relPubl>
      <othRefs xml:lang="FR"/>
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