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<docDscr>
  <citation>
    <titlStmt>
      <titl>Cross-Sectional Study on Adverse Events Linked to Ambulatory Care</titl>
      <IDNo>FRESH-PEF9027-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="COMITE DE COORDINATION DE L&amp;#x27;EVALUATION CLINIQUE ET DE LA QUALITE EN NOUVELLE-AQUITAINE (CCECQA)" role="">Philippe MICHEL</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Cross-Sectional Study on Adverse Events Linked to Ambulatory Care            </titl>
      <altTitl>
                    EVISA                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF9027-en            </IDNo>
      <IDNo agency="PEF">
                    9027                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF9027                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Philippe MICHEL                                                                                </AuthEnty>
      <AuthEnty affiliation="COMITE DE COORDINATION DE L&amp;#039;EVALUATION CLINIQUE ET DE LA QUALITE EN NOUVELLE-AQUITAINE (CCECQA)">
        <ExtLink title="SIREN" URI="409084308" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
                    Jean-Luc QUENON                                                                                </AuthEnty>
      <AuthEnty affiliation="COMITE DE COORDINATION DE L&amp;#039;EVALUATION CLINIQUE ET DE LA QUALITE EN NOUVELLE-AQUITAINE (CCECQA)">
        <ExtLink title="SIREN" URI="409084308" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            ARS NOUVELLE AQUITAINE                    
                                    </producer>
      <producer role="sponsor">
                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="COMITE DE COORDINATION DE L'EVALUATION CLINIQUE ET DE LA QUALITE EN NOUVELLE-AQUITAINE (CCECQA)" email="philippe.michel@chu-lyon.fr">
                    Philippe;MICHEL
                                            <ExtLink title="SIREN" URI="409084308" role="organisation id"/>
                                    </contact>
      <contact affiliation="COMITE DE COORDINATION DE L'EVALUATION CLINIQUE ET DE LA QUALITE EN NOUVELLE-AQUITAINE (CCECQA)" email="jean-luc.quenon@ccecqa.asso.fr">
                    Jean-Luc;QUENON
                                            <ExtLink title="SIREN" URI="409084308" role="organisation id"/>
                                    </contact>
      <depDate date="2026-06-16"/>
      <distDate date="2026-06-16"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    iatrogenesis</keyword>
      <keyword vocab="" vocabURI="">
                    treatment-related adverse event</keyword>
      <keyword vocab="" vocabURI="">
                    medical accidents and incidents</keyword>
      <keyword vocab="" vocabURI="">
                    outpatient care</keyword>
      <keyword vocab="" vocabURI="">
                    patient safety</keyword>
      <keyword vocab="" vocabURI="">
                    nosocomial</keyword>
      <keyword vocab="" vocabURI="">
                    health safety</keyword>
      <keyword vocab="" vocabURI="">
                    risk</keyword>
      <topcClas vocab="health theme">
                        Emergency medicine                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/5e1591e2-d02b-436c-8216-6b8912eee467"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D004635"/>
                                                </topcClas>
    </subject>
    <abstract contentType="purpose">To estimate the frequency, severity and preventability of adverse events linked to ambulatory care, as well as investigate the context and contributing factors on the occurrence of these events and to estimate the hospital treatment costs.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2008-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">Patients population                    </universe>
      <universe level="sex" clusion="I">Male                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008297"/>
                                                    </universe>
      <universe level="sex" clusion="I">Female                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D005260"/>
                                                    </universe>
      <universe level="age" clusion="I">Young Adult (19 to 24 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D055815"/>
                                                    </universe>
      <universe level="age" clusion="I">Adult (25 to 44 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000328"/>
                                                    </universe>
      <universe level="age" clusion="I">Middle Aged (45 to 64 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008875"/>
                                                    </universe>
      <universe clusion="I">Male and female; - Patients hospitalised in medical and surgical departments in short-stay healthcare institutions.                    </universe>
      <dataKind>Participant-reported health data</dataKind>
    </sumDscr>
    <qualityStatement>
      <standardsCompliance>
        <standard>
          <standardName>Data quality control was carried out in three stages:</standardName>
        </standard>
      </standardsCompliance>
      <otherQualityStatement>- The CCECQA (Coordination Committee for Clinical Evaluation and Quality in Aquitaine) carried out checks in institutions to verify proper data collection conduct</otherQualityStatement>
      <otherQualityStatement>adherence to the method</otherQualityStatement>
      <otherQualityStatement>as well as the completeness and quality of collected data. - Researchers and research associates coded questionnaires and checked for completeness and consistency. - All questionnaires were reviewed by CCECQA methodologists. Problematic records (unclear; inconsistent; complex clinical situation; episodes</otherQualityStatement>
      <otherQualityStatement>causes or impact of an unusual event</otherQualityStatement>
      <otherQualityStatement>etc.) were reviewed by a case review committee and</otherQualityStatement>
      <otherQualityStatement>if required</otherQualityStatement>
      <otherQualityStatement>by field experts.</otherQualityStatement>
    </qualityStatement>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity
Health event/mortality</description>
    </developmentActivity>
  </studyDevelopment>
  <method>
    <dataColl>
      <timeMeth>One-time cross-sectional study</timeMeth>
      <sampProc>Probability: Stratified                                                            <concept vocab="CESSDA" vocabURI="Probability.Stratified"/>
                                                    </sampProc>
      <sampleFrame>
        <frameUnit>
          <unitType>Through organizations (health services or institutions</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>schools</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>businesses</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>etc.)</unitType>
        </frameUnit>
      </sampleFrame>
      <targetSampleSize>
        <sampleSizeFormula>&lt; 500 individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Interview with the participant (including clinical)                                                            <concept vocab="CESSDA" vocabURI="Interview"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <anlyInfo>
      <respRate>47</respRate>
    </anlyInfo>
    <stdyClas>Completed study</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
    <useStmt>
      <conditions>Contact the principal investigator</conditions>
    </useStmt>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
