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<docDscr>
  <citation>
    <titlStmt>
      <titl>Longitudinal Study on Patients with Irritable Bowel Syndrome: Epidemiological Monitoring and Cost</titl>
      <IDNo>FRESH-PEF8715-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)" role="">Jean-Marc SABATE</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Longitudinal Study on Patients with Irritable Bowel Syndrome: Epidemiological Monitoring and Cost            </titl>
      <altTitl>
                    SECSII                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF8715-en            </IDNo>
      <IDNo agency="PEF">
                    8715                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF8715                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Jean-Marc SABATE                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)">
        <ExtLink title="ROR" URI="https://ror.org/00pg5jh14" role="organisation id"/>
        <ExtLink title="SIREN" URI="267500452" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="E-cost European project GENIEUR (www.genieur.eu)" type="collaboration">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            ASSOCIATION NATIONALE DES HEPATO-GASTROENTEROLOGUES DES HOPITAUX GENERAUX DE FRANCE                    
                                    </producer>
      <producer role="sponsor">
                                            ASS DES PATIENTS SOUFFRANTS DU SYNDROME DE L INTESTIN IRRITABLE (APSSII)                    
                                    </producer>
      <producer role="sponsor">
                                            GROUPE FRANCAIS DE NEURO-GASTRO-ENTEROLOGIE (GFNG)                    
                                    </producer>
      <producer role="sponsor">
                                            CLUB REFLEXION GROUPES DE GASTRO ENTEROL (CREGG)                    
                                    </producer>
      <producer role="sponsor">
                                            SOCIETE NATIONALE FRANÇAISE DE GASTRO-ENTEROLOGIE                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            SOCIETE NATIONALE FRANÇAISE DE GASTRO-ENTEROLOGIE                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)" email="jean-marc.sabate@aphp.fr">
                    Jean-Marc;SABATE
                                            <ExtLink title="ROR" URI="https://ror.org/00pg5jh14" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="267500452" role="organisation id"/>
                                    </contact>
      <depDate date="2026-06-17"/>
      <distDate date="2026-06-17"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    irritable bowel syndrome</keyword>
      <keyword vocab="" vocabURI="">
                    abdominal pain</keyword>
      <keyword vocab="" vocabURI="">
                    altered bowel habits</keyword>
      <keyword vocab="" vocabURI="">
                    direct cost</keyword>
      <keyword vocab="" vocabURI="">
                    indirect cost</keyword>
      <keyword vocab="" vocabURI="">
                    severity</keyword>
      <keyword vocab="" vocabURI="">
                    diagnosis</keyword>
      <keyword vocab="" vocabURI="">
                    treatment</keyword>
      <topcClas vocab="health theme">
                        Gastroenterology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/a3898340-a42d-4f5e-a822-1de204a9a867"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D005762"/>
                                                </topcClas>
      <topcClas vocab="cim-11">
                        Irritable bowel syndrome                                            </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants: Use of care                    </topcClas>
      <topcClas vocab="health determinant">
                        Socio-demographic and economic determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants: Eating habits                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">Irritable bowel syndrome (IBS), which involves abdominal pain and altered bowel habits, is a common disease that affects 5% of the population. There is no diagnostic test provided and the treatments used are often ineffective. IBS may significantly reduce quality of life and impact daily activities and work. All of these factors can contribute to increased consultations and treatment and, as such, the overall cost of the disease in France for which there is no recent data. The aim of this cohort is to describe the actual overall cost of IBS by assessing direct costs (examinations, consultations, hospitalisations, reimbursed or non-reimbursed treatment, self-medication, alternative treatments), and indirect costs (work disruption, reduced productivity), assessing the role of factors linked to the disease (IBS type, severity, disease history) and the treatment type (centres of expertise, hospital, practice). This is a multicentric French cohort of IBS patients for carrying out health economics and epidemiological analyses (increased knowledge of prognostic demographic factors, history, comorbidities, predominant symptoms, type of treatment).</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2014-01-01"/>
      <collDate event="end" date="2018-01-01"/>
      <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 level="age" clusion="I">Aged (65 to 79 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000368"/>
                                                    </universe>
      <universe clusion="I">Aged 18 to 75 years old; - Suffering from IBS (ROME-II criteria); - Normal digestive examinations (total colonoscopy and/or normal barium enema for subjects aged 50 or over, proctosigmoidoscopy and/or normal barium enema in people under 50 years old). These examinations should be carried out 5 years prior to enrolment for patients over 50 years old. There is no time limit for patients under 50 years of age. - Satisfactory level of French language comprehension and expression. - Internet access or agreement to send questionnaires by post.                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
    </sumDscr>
    <qualityStatement>
      <otherQualityStatement>Real-time monitoring with CRA.</otherQualityStatement>
    </qualityStatement>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity
Health care consumption and services
Quality of life/health perception</description>
    </developmentActivity>
  </studyDevelopment>
  <method>
    <dataColl>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <targetSampleSize>
        <sampleSizeFormula>&lt; 500 individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <anlyInfo>
      <respRate>500</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
    <useStmt>
      <conditions>Contact the scientist in charge for further information.</conditions>
    </useStmt>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
