<?xml version="1.0" encoding="UTF-8"?>
<codeBook version="2.5" ID="FRESH-PEF74119-en" xml-lang="en" xmlns="ddi:codebook:2_5" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="ddi:codebook:2_5 https://ddialliance.org/Specification/DDI-Codebook/2.5/XMLSchema/codebook.xsd">
<docDscr>
  <citation>
    <titlStmt>
      <titl>Benefits of a spa treatment at Saint-Lary Soulan for knee osteoarthritis</titl>
      <IDNo>FRESH-PEF74119-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="UNIVERSITE DE BORDEAUX" role="">Cécile DROZ-PERROTEAU</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Benefits of a spa treatment at Saint-Lary Soulan for knee osteoarthritis            </titl>
      <altTitl>
                    LARYTHERM-Rhumato                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF74119-en            </IDNo>
      <IDNo agency="PEF">
                    74119                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF74119                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Patrick BLIN                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="UNIVERSITE DE BORDEAUX">
        <ExtLink title="ROR" URI="https://ror.org/057qpr032" role="organisation id"/>
        <ExtLink title="SIREN" URI="130018351" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
                    Laure CARCAILLON-BENTATA                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="UNIVERSITE DE BORDEAUX">
        <ExtLink title="ROR" URI="https://ror.org/057qpr032" role="organisation id"/>
        <ExtLink title="SIREN" URI="130018351" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            UNIVERSITE DE BORDEAUX                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            COMMUNE DE SAINT LARY SOULAN                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="" email="">
                    
                                    </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="">
                    Spa treatment</keyword>
      <keyword vocab="" vocabURI="">
                    cohort</keyword>
      <keyword vocab="" vocabURI="">
                    knee osteoarthritis</keyword>
      <keyword vocab="" vocabURI="">
                    functional disability</keyword>
      <keyword vocab="" vocabURI="">
                    pain</keyword>
      <keyword vocab="" vocabURI="">
                    fatigue</keyword>
      <keyword vocab="" vocabURI="">
                    quality of life</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>
    </subject>
    <abstract contentType="purpose">The primary objective is to evaluate the comparative efficacy at 6 months of a spa treatment in Saint-Lary Soulan on functional disability and pain (MCII: Minimal Clinical Important Improvement) in knee osteoarthritis compared to the control group in the Thermarthrose multicentre randomised clinical trial, receiving standard care.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2023-01-01"/>
      <collDate event="end" date="2024-01-01"/>
      <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 level="age" clusion="I">Aged, 80 and over (80 years and more)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000369"/>
                                                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
    </sumDscr>
    <qualityStatement>
      <otherQualityStatement>The various questionnaires used in the study will be monitored by an Epidemiological Research Assistant in order to verify data consistency. The latter may contact the spa doctor in the event of questionnaires not being returned or if clarification is required regarding the data provided. An Epidemiological Research Associate may also check the data collected on site.</otherQualityStatement>
    </qualityStatement>
  </stdyInfo>
  <method>
    <dataColl>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </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>
      <collMode>Self-administered questionnaire                                                            <concept vocab="CESSDA" vocabURI="SelfAdministeredQuestionnaire"/>
                                                    </collMode>
      <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>
    <notes subject="observational study method">
                        Cohort study                    </notes>
    <anlyInfo>
      <respRate>minimum 80 patients - maximum 171 patients</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            To be defined                                                    </avlStatus>
    </setAvail>
    <notes>Ownership and access to the study data are covered by an agreement between the Université de Bordeaux, ADERA SAS and the commune of Saint-Lary Soulan. Terms of access to the database are to be defined for any third party.</notes>
  </dataAccs>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
