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<docDscr>
  <citation>
    <titlStmt>
      <titl>Cross-Sectional Study on Primary Care for Adverse Events</titl>
      <IDNo>FRESH-PEF9015-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 Primary Care for Adverse Events            </titl>
      <altTitl>
                    ESPRIT                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF9015-en            </IDNo>
      <IDNo agency="PEF">
                    9015                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF9015                </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>
      <othId affiliation="Partnership with Open Rome http://esprit.openrome.org/documents/Rapport_ESPRIT_final.pdf" type="collaboration">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            COMITE DE COORDINATION DE L&amp;#039;EVALUATION CLINIQUE ET DE LA QUALITE EN NOUVELLE-AQUITAINE (CCECQA)                    
                                    </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>
      <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="">
                    risk management</keyword>
      <keyword vocab="" vocabURI="">
                    frequency</keyword>
      <keyword vocab="" vocabURI="">
                    adverse events</keyword>
      <topcClas vocab="health theme">
                        General medicine                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/4b9f8efb-68dd-45a1-b04c-d23d457d6898"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D058006"/>
                                                </topcClas>
    </subject>
    <abstract contentType="purpose">To estimate the incidence of avoidable treatment-related adverse effects in general medicine and to describe the typology.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2012-01-01"/>
      <collDate event="end" date="2013-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">General 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 seen or contacted by voluntary general practitioners from the study.                    </universe>
      <dataKind>Participant-reported health data</dataKind>
    </sumDscr>
    <qualityStatement>
      <otherQualityStatement>Data completeness will be monitored: ‐ in real time</otherQualityStatement>
      <otherQualityStatement>- when files arrive to Open Rome by post. If required</otherQualityStatement>
      <otherQualityStatement>the organisation will contact to the physician again to adjust or supplement data collection. The quality of data recording and consistency will be checked by those in charge of the database in accordance with regular procedures</otherQualityStatement>
    </qualityStatement>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity
Quality of life/health perception</description>
    </developmentActivity>
  </studyDevelopment>
  <method>
    <dataColl>
      <timeMeth>One-time cross-sectional study</timeMeth>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <sampleFrame>
        <frameUnit>
          <unitType>Through independent healthcare practitioners</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>475</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>
