<?xml version="1.0" encoding="UTF-8"?>
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<docDscr>
  <citation>
    <titlStmt>
      <titl>Patient Acceptable Symptomatic State</titl>
      <IDNo>FRESH-PEF93-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="SANOFI (FRANCE)" role="">Franck VIGNAL</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Patient Acceptable Symptomatic State            </titl>
      <altTitl>
                    PASS-ARTHROSE                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF93-en            </IDNo>
      <IDNo agency="PEF">
                    93                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF93                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Franck VIGNAL                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="SANOFI (FRANCE)">
        <ExtLink title="ROR" URI="https://ror.org/02n6c9837" role="organisation id"/>
        <ExtLink title="SIREN" URI="395030844" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            SANOFI (FRANCE)                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="SANOFI (FRANCE)" email="franck.vignal@sanofi.com">
                    Franck;VIGNAL
                                            <ExtLink title="ROR" URI="https://ror.org/02n6c9837" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="395030844" 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="">
                    evaluation of the pain and response to antalgic treatment</keyword>
      <keyword vocab="" vocabURI="">
                    PASS</keyword>
      <keyword vocab="" vocabURI="">
                    Minimal Clinically Important Improvement (MCII)</keyword>
      <topcClas vocab="health theme">
                        Rheumatology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/bfb0bafd-7894-45ba-84fc-ddab5fd6c537"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D012219"/>
                                                </topcClas>
      <topcClas vocab="cim-11">
                        Osteoarthritis                                            </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">Determine, in patients suffering from arthrosis of the lower limbs, the percentage of patients that find their pain "acceptable" at rest and when movement, after one week of treatment, according to the PASS concept (Patient Acceptable Symptomatic State).</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2009-01-01"/>
      <collDate event="end" date="2010-01-01"/>
      <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">Middle Aged (45 to 64 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008875"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged (65 to 79 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000368"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged, 80 and over (80 years and more)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000369"/>
                                                    </universe>
      <universe clusion="I">Patients must: • be ambulatory, • be aged 50 years or older, • consult for a defined gonarthrosis and/or coxarthrosis according to the clinical or radiological criteria of the American College of Rheumatology,  • be symptomatic with pain greater or equal to 3 on a numerical pain scale from 0 to 10, at rest or during movement, in the 24 hours preceding entry in the study, • requiring the taking of an antalgic treatment for a duration of at least one week, • be able and accept to complete a self-evaluation questionnaire, • accepting to participate in the survey.                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
      <dataKind>Socio-demographic data</dataKind>
    </sumDscr>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health care consumption and services
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 Medical-administrative database (patients</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>health insurance/mutual insurance) Disease and death registry</unitType>
        </frameUnit>
      </sampleFrame>
      <targetSampleSize>
        <sampleSizeFormula>[1000-10000[ individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Self-administered questionnaire                                                            <concept vocab="CESSDA" vocabURI="SelfAdministeredQuestionnaire"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <anlyInfo>
      <respRate>3329</respRate>
    </anlyInfo>
    <stdyClas>Completed study</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            To be defined                                                    </avlStatus>
    </setAvail>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
