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  <docDscr>
    <citation>
      <titlStmt>
        <titl xml:lang="FR">Cohorte de patients du service d'hématologie admis en réanimation : qualité de vie à long terme</titl>
        <subTitl/>
        <altTitl xml:lang="FR">TRIAL-OH</altTitl>
        <altTitl xml:lang="EN">TRIAL-OH</altTitl>
        <parTitl xml:lang="EN">Cohort of Haematological Patients Admitted to Intensive Care: Long-Term Quality of Life</parTitl>
        <IDNo>PEF5007</IDNo>
      </titlStmt>
      <rspStmt>
        <AuthEnty affiliation="ITMO Santé Publique, Aviesan">Portail Épidémiologie-France</AuthEnty>
        <othId/>
      </rspStmt>
      <prodStmt>
        <producer abbr="PEF-HD" affiliation="ITMO Santé Publique, Aviesan">Portail Épidémiologie-France | Health Databases</producer>
        <copyright>Portail Épidémiologie-France 2026</copyright>
        <prodDate date="2026-04-11">11/04/2026</prodDate>
        <prodPlac>https://epidemiologie-france.aviesan.fr/</prodPlac>
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      <distStmt>
        <distrbtr>Portail Épidémiologie-France</distrbtr>
        <contact email="portail-epidemiologie@inserm.fr">Portail Epidemiologie-France</contact>
        <depositr>Elie Azoulay</depositr>
        <depDate xml:lang="FR">07/12/2012</depDate>
        <depDate xml:lang="EN">23/06/2016</depDate>
        <distDate>07/12/2012</distDate>
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        <version xml:lang="FR" date="07/12/2012">2</version>
        <version xml:lang="EN" date="23/06/2016">1</version>
        <verResp>Elie Azoulay</verResp>
        <notes/>
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      <biblCit/>
      <holdings xml:lang="FR" location="Portail Epidemiologie-France" URI="http://admin-epid-prod2.inserm.fr/fr/content/view/full/88354">TRIAL-OH - Cohorte de patients du service d'hématologie admis en réanimation : qualité de vie à long terme</holdings>
      <holdings xml:lang="EN" location="Portail Epidemiologie-France" URI="http://admin-epid-prod2.inserm.fr/fr/content/view/full/88558">TRIAL-OH - Cohort of Haematological Patients Admitted to Intensive Care: Long-Term Quality of Life</holdings>
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  <stdyDscr>
    <citation>
      <titlStmt>
        <titl xml:lang="FR">Cohorte de patients du service d'hématologie admis en réanimation : qualité de vie à long terme</titl>
        <subTitl/>
        <altTitl xml:lang="FR">TRIAL-OH</altTitl>
        <altTitl xml:lang="EN">TRIAL-OH</altTitl>
        <parTitl xml:lang="EN">Cohort of Haematological Patients Admitted to Intensive Care: Long-Term Quality of Life</parTitl>
        <IDNo/>
      </titlStmt>
      <rspStmt>
        <AuthEnty affiliation="Intensive care department, Saint-Louis Hospital">Elie Azoulay</AuthEnty>
      </rspStmt>
      <prodStmt>
        <producer role="Secteur Public">Saint-Louis Hospital</producer>
        <copyright/>
        <prodDate/>
        <prodPlac>UMR S-717, Prof. Sylvie Chevret - Intensive care department, Saint-Louis Hospital - Service de réanimation, Hôpital Saint-Louis, Paris</prodPlac>
        <software/>
        <fundAg xml:lang="FR" role="Mixte">Le programme hospitalier de recherche clinique (PHRC), Société Française des Infirmiers de Soins Intensifs, Ministère de la santé</fundAg>
        <fundAg xml:lang="EN" role="Mixed">Hospital Clinical Research Programme (PHRC); French Society of Intensive Care Nurses; Ministry of Health</fundAg>
        <grantNo/>
      </prodStmt>
      <distStmt>
        <distrbtr>Intensive care department, Saint-Louis Hospital</distrbtr>
        <contact affiliation="Intensive care department, Saint-Louis Hospital" email="Elie.azoulay@sls.aphp.fr">Elie Azoulay</contact>
        <depositr>Elie Azoulay</depositr>
        <depDate xml:lang="FR">07/12/2012</depDate>
        <depDate xml:lang="EN">23/06/2016</depDate>
        <distDate xml:lang="FR">07/12/2012</distDate>
        <distDate xml:lang="EN">23/06/2016</distDate>
      </distStmt>
      <serStmt>
        <serName/>
        <serInfo/>
      </serStmt>
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        <version xml:lang="FR" date="07/12/2012">2</version>
        <version xml:lang="EN" date="23/06/2016">1</version>
        <verResp>Elie Azoulay</verResp>
        <notes/>
      </verStmt>
      <biblCit/>
      <holdings/>
      <notes/>
    </citation>
    <studyAuthorization>
      <authorizingAgency/>
      <authorizationStatement/>
    </studyAuthorization>
    <stdyInfo>
      <studyBudget/>
      <subject>
        <keyword xml:lang="FR">hématologie</keyword>
        <keyword xml:lang="FR">réanimation</keyword>
        <keyword xml:lang="FR">évaluation</keyword>
        <keyword xml:lang="FR">qualité de vie</keyword>
        <keyword xml:lang="FR">long terme</keyword>
        <keyword xml:lang="EN">long term</keyword>
        <keyword xml:lang="EN">haematology</keyword>
        <keyword xml:lang="EN">intensive care</keyword>
        <keyword xml:lang="EN">assessment</keyword>
        <keyword xml:lang="EN">quality of life</keyword>
        <topcClas xml:lang="FR">Hématologie</topcClas>
        <topcClas xml:lang="EN">Hematology</topcClas>
        <topcClas xml:lang="FR">Facteurs sociaux et psycho-sociaux</topcClas>
        <topcClas xml:lang="FR">Mode de vie et comportements</topcClas>
        <topcClas xml:lang="FR">Systèmes de soins et accès aux soins</topcClas>
        <topcClas xml:lang="EN">Social and psychosocial factors</topcClas>
        <topcClas xml:lang="EN">Lifestyle and behavior</topcClas>
        <topcClas xml:lang="EN">Healthcare system and access to health care services</topcClas>
      </subject>
      <abstract xml:lang="FR">Objectif de la base de données : Evaluer la qualité de vie au long terme (à 1 et 2 ans) des patients d’hématologie ayant survécu à une admission en réanimation, et de modéliser l’évolution de celle-ci depuis la sortie de réanimation.</abstract>
      <abstract xml:lang="EN">Database objective : To assess long-term quality of life (at 1 and 2 years) for haematology patients that survived ICU admission and to model the outcome of this following discharge from ICU.</abstract>
      <sumDscr>
        <timePrd/>
        <collDate event="start">2010</collDate>
        <collDate event="end">2013</collDate>
        <collDate xml:lang="FR">Collecte des données terminée</collDate>
        <collDate xml:lang="EN">Data collection completed</collDate>
        <nation>France</nation>
        <geogCover xml:lang="FR">France et Belgique</geogCover>
        <geogCover xml:lang="EN">France and Belgium</geogCover>
        <geogUnit>International</geogUnit>
        <anlyUnit xml:lang="fr">individuel
                </anlyUnit>
        <anlyUnit xml:lang="en">individuals
                </anlyUnit>
        <universe xml:lang="FR" clusion="I">Patients atteints de leucémies, lymphomes malins et myélomes multiples dans 17 services de France et Belgique</universe>
        <universe xml:lang="EN" clusion="I">Patients with leukaemia, lymphoma and multiple myeloma in 17 departments throughout France and Belgium.</universe>
        <universe xml:lang="FR">Nombre d'individus : 1376</universe>
        <universe xml:lang="EN">Number of individuals: 1,376</universe>
        <universe xml:lang="FR">Recrutement via une sélection de professionnels d'exercice libéral</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 care professionals</universe>
        <universe xml:lang="EN">Recruiting through a selection of health institutions and services</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 de cohortes</dataKind>
        <dataKind xml:lang="EN">Cohort study</dataKind>
        <dataKind xml:lang="FR">Données cliniques : traintement et statut de la maladie, Sepsis-Related Organ Failure Assessment (SOFA) score, indice de performance, comorbidités, diagnostics étiologiques, </dataKind>
        <dataKind xml:lang="FR">Données déclaratives : Téléphone</dataKind>
        <dataKind xml:lang="EN">Clinical data: Disease status and treatment, Sepsis-Related Organ Failure Assessment (SOFA) score, performance index, comorbidity, etiological diagnoses.</dataKind>
        <dataKind xml:lang="EN">Declarative data: Phone interview</dataKind>
        <dataKind xml:lang="FR">Evénements de santé/morbidité</dataKind>
        <dataKind xml:lang="FR">Evénements de santé/mortalité</dataKind>
        <dataKind xml:lang="FR">Consommation de soins/services de santé</dataKind>
        <dataKind xml:lang="FR">Qualité de vie/santé perçue</dataKind>
        <dataKind xml:lang="EN">Health event/morbidity</dataKind>
        <dataKind xml:lang="EN">Health event/mortality</dataKind>
        <dataKind xml:lang="EN">Health care consumption and services</dataKind>
        <dataKind xml:lang="EN">Quality of life/health perception</dataKind>
        <dataKind xml:lang="FR">Hospitalisation</dataKind>
        <dataKind xml:lang="EN">Hospitalization</dataKind>
      </sumDscr>
      <qualityStatement>
        <standardsCompliance>
          <standard>
            <standardName/>
            <producer/>
          </standard>
          <complianceDescription/>
        </standardsCompliance>
        <otherQualityStatement xml:lang="FR"/>
        <otherQualityStatement xml:lang="EN"/>
        <otherQualityStatement xml:lang="FR"/>
        <otherQualityStatement xml:lang="EN"/>
      </qualityStatement>
      <notes/>
      <exPostEvaluation>
        <evaluator/>
        <evaluationProcess/>
        <outcomes/>
      </exPostEvaluation>
    </stdyInfo>
    <studyDevelopment>
      <developmentActivity>
        <description/>
        <participant/>
        <resource>
          <dataSrc/>
          <dataSrc/>
          <dataSrc/>
          <dataSrc/>
          <srcOrig/>
          <srcChar/>
          <srcDocu/>
        </resource>
        <outcome/>
      </developmentActivity>
    </studyDevelopment>
    <method>
      <dataColl>
        <timeMeth method="http://www.ddialliance.org/Specification/DDI-CV/TimeMethod_1.2_Genericode1.0_DDI-CVProfile1.0.xml">Longitudinal: Cohort/Event-based</timeMeth>
        <dataCollector affiliation="Intensive care department, Saint-Louis Hospital">Elie Azoulay</dataCollector>
        <collectorTraining/>
        <frequenc xml:lang="FR">A 1 an et à 2 ans</frequenc>
        <frequenc xml:lang="EN">At 1 and 2 years</frequenc>
        <sampProc xml:lang="FR"/>
        <sampProc xml:lang="EN"/>
        <deviat/>
        <collMode xml:lang="FR">Les 500 patients survivant à J90, et leur proche (un proche par patient, le plus souvent le conjoint), seront appelés 12 à 15 mois après la sortie de réanimation afin de faire passer les questionnaires SF-36 (36 questions sur la qualité de vie), Hospital Anxiety and Depression Scale (14 questions sur les symptômes d’anxiété et de dépression) et Impact of Event Scale (22 questions sur le Stress post traumatique). Les patients hospitalisés au moment de l’appel seront rappelés 15 jours après la sortie de l’hôpital</collMode>
        <collMode xml:lang="EN">500 surviving patients at day 90 and their friends or relatives (one person per patient, most often the spouse) will be contacted 12 to 15 months following discharge from ICU to complete the following questionnaires: SF-36 (36 questions on quality of life), Hospital Anxiety and Depression Scale (14 questions on depressive and anxiety symptoms) and Impact of Event Scale (22 questions on post-traumatic stress). Patients admitted to hospital at time of contact will be contacted again 15 days following discharge from hospital.</collMode>
        <collMode xml:lang="FR">Téléphone : Qualité de vie (SF-36)</collMode>
        <collMode xml:lang="EN">Phone interview: Qualité de vie (SF-36)</collMode>
        <collMode xml:lang="FR"/>
        <collMode xml:lang="EN"/>
        <collMode xml:lang="FR"/>
        <collMode xml:lang="EN"/>
        <resInstru/>
        <instrumentDevelopment/>
        <sources>
          <dataSrc/>
          <srcOrig/>
          <srcChar/>
          <srcDocu/>
        </sources>
        <collSitu/>
        <actMin/>
        <ConOps/>
        <weight/>
        <cleanOps/>
      </dataColl>
      <notes/>
      <anlyInfo>
        <respRate/>
        <EstSmpErr/>
        <dataAppr/>
      </anlyInfo>
      <stdyClas/>
      <dataProcessing/>
      <codingInstructions>
        <txt/>
        <command/>
      </codingInstructions>
    </method>
    <dataAccs>
      <setAvail>
        <accsPlac/>
        <origArch/>
        <avlStatus xml:lang="FR">A définir</avlStatus>
        <avlStatus xml:lang="EN">To be decided.</avlStatus>
        <collSize/>
        <complete/>
        <fileQnty/>
        <notes/>
      </setAvail>
      <useStmt>
        <confDec/>
        <specPerm/>
        <restrctn xml:lang="FR">A définir</restrctn>
        <restrctn xml:lang="EN">To be decided.</restrctn>
        <contact/>
        <citReq/>
        <deposReq/>
        <conditions xml:lang="FR">A définir</conditions>
        <conditions xml:lang="EN">To be decided.</conditions>
        <disclaimer/>
      </useStmt>
      <notes/>
    </dataAccs>
    <othrStdyMat>
      <relMat xml:lang="FR"/>
      <relMat xml:lang="FR"/>
      <relStdy/>
      <relPubl xml:lang="FR">http://jco.ascopubs.org/content/31/22/2810.long</relPubl>
      <relPubl xml:lang="EN">http://jco.ascopubs.org/content/31/22/2810.long</relPubl>
      <othRefs xml:lang="FR"/>
      <othRefs xml:lang="EN"/>
    </othrStdyMat>
    <notes/>
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