<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03836612</url>
  </required_header>
  <id_info>
    <org_study_id>P003</org_study_id>
    <nct_id>NCT03836612</nct_id>
  </id_info>
  <brief_title>Healthcare Resource Utilisation, Common Mental Health Problems, and Infections in People With Inflammatory Bowel Disease</brief_title>
  <official_title>Healthcare Resource Utilisation, Common Mental Health Problems, and Infections in People With Inflammatory Bowel Disease (IBD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Momentum Data</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Surrey</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Momentum Data</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ulcerative colitis and Crohn's disease are the commonest types of inflammatory bowel disease&#xD;
      (IBD). Both conditions range in severity from no symptoms to being potentially fatal. Both&#xD;
      conditions are treated with medications which suppress the immune system. It is not known&#xD;
      whether this increases the risk for infections and cancers in these conditions. It is also&#xD;
      recognised by healthcare professionals that these conditions cause a considerable amount of&#xD;
      psychological distress. However, this has never been measured in a large population sample.&#xD;
&#xD;
      This study will investigate any associations with treatment and new onset infections and&#xD;
      cancer. They will also examine the relationship between IBD and common mental health problems&#xD;
      (specifically, depression and anxiety) and the impact that these have on the healthcare use&#xD;
      (including number of general practitioner [GP] appointments, hospital attendances, and&#xD;
      medication prescriptions. Combined, these studies should provide a better understanding of&#xD;
      the impact of IBD on affected people and provide evidence to support the correct allocation&#xD;
      of healthcare resources.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective We aim to provide an accurate and contemporary measurement of the current&#xD;
      healthcare resource utilisation in people with inflammatory bowel disease (IBD); namely&#xD;
      ulcerative colitis (UC) and Crohn's disease (CD). We also aim to provide estimates of&#xD;
      infection incidence in this population and the prevalence of common mental health conditions.&#xD;
&#xD;
      Method We will identify UC and CD using algorithms validated for accurately identifying these&#xD;
      conditions from primary care records in the United Kingdom (UK). We will identify a prevalent&#xD;
      cohort of adults with IBD with the Royal College of General Practitioners (RCGP) Research and&#xD;
      Surveillance Centre (RSC) network over the last decade. We will identify a matched cohort of&#xD;
      people without IBD; matched on age, gender and primary care practice. Across these cohorts we&#xD;
      will compare healthcare resource utilisation (primary care attendances, number of primary&#xD;
      care prescriptions for antidepressant and anxiolytic medications, number of primary care&#xD;
      prescriptions for medications used in IBD, recorded secondary care attendances, and issue of&#xD;
      statements of fitness for work), incident infections (any common infection, any viral&#xD;
      infection, or any gastrointestinal infection), and common mental health conditions&#xD;
      (depression and anxiety).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">November 1, 2019</completion_date>
  <primary_completion_date type="Actual">September 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of Anxiety Episodes (Crohn's Disease)</measure>
    <time_frame>Measured over five years - 2014 to 2018 inclusive</time_frame>
    <description>Compare the prevalence of anxiety episodes in people with and without Crohn's disease.&#xD;
Number of people with at least one anxiety episode in people.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of Anxiety Episodes (Ulcerative Colitis)</measure>
    <time_frame>Measured over five years - 2014 to 2018 inclusive</time_frame>
    <description>Compare the prevalence of anxiety episodes in people with and without Ulcerative Colitis.&#xD;
Number of people with at least one anxiety episode</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of Depressive Episodes (Crohn's Disease)</measure>
    <time_frame>Measured over five years - 2014 to 2018 inclusive</time_frame>
    <description>Compare the prevalence of depressive episodes in people with and without Crohn's disease.&#xD;
Number of people with at least one depressive episode</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of Depressive Episodes (Ulcerative Colitis)</measure>
    <time_frame>Measured over five years - 2014 to 2018 inclusive</time_frame>
    <description>Compare the prevalence of depressive episodes in people with and without Ulcerative Colitis.&#xD;
Number of people with at least one depressive episode.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of People With Depressive Disorder in People With and Without Crohn's Disease</measure>
    <time_frame>Measured over five years - 2014 to 2018 inclusive</time_frame>
    <description>Compare the prevalence of depressive disorder in people with and without Crohn's disease.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of People With Depressive Disorder in People With and Without Ulcerative Colitis</measure>
    <time_frame>Measured over five years - 2014 to 2018 inclusive</time_frame>
    <description>Compare the prevalence of depressive disorder in people with and without Ulcerative Colitis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of People With at Least One Infection Event in Those With and Without Ulcerative Colitis</measure>
    <time_frame>Measured over 5 years - 2014 to 2018 inclusive</time_frame>
    <description>Number of people with at least one infection event during follow up for any common infection, gastrointestinal infection, and any viral infection.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of People With at Least One Infection Event in Those With and Without Crohn's Disease</measure>
    <time_frame>Measured over 5 years - 2014 to 2019 inclusive</time_frame>
    <description>Number of people with at least one infection event during follow up for any common infection, gastrointestinal infection, and any viral infection.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of People With at Least One Sub-infection Event in Those With and Without Ulcerative Colitis</measure>
    <time_frame>Measured over 5 years - 2014 to 2019 inclusive</time_frame>
    <description>Sub-infection outcomes: Upper respiratory tract infection (URTI), Pneumonia, Acute Bronchitis, Influenza, Skin infection, Genital infection, urinary tract infection (UTI), GI infection subset (only stool culture confirmed Clostridium difficile, Salmonella, Shigella, and Campylobacter infections), Herpes Simplex infection, Herpes Zoster infection</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of People With at Least One Sub-infection Event in Those With and Without Crohn's Disease</measure>
    <time_frame>Measured over 5 years - 2014 to 2019 inclusive</time_frame>
    <description>Sub-infection outcomes: URTI, Pneumonia, Acute Bronchitis, Influenza, Skin infection, Genital infection, UTI, GI infection subset (only stool culture confirmed Clostridium difficile, Salmonella, Shigella, and Campylobacter infections), Herpes Simplex infection, Herpes Zoster infection</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Healthcare Resource Utilization - Primary Care Visits</measure>
    <time_frame>Measured over five years - 2014 to 2018 inclusive</time_frame>
    <description>Compare healthcare resource utilization in people with and without IBD, and stratifying by IBD type and compare healthcare resource utilization in people with IBD, with and without mental health illness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare Resource Utilization - Secondary Care Emergency Attendances</measure>
    <time_frame>Measured over five years - 2014 to 2018 inclusive</time_frame>
    <description>Compare healthcare resource utilization in people with and without IBD, and stratifying by IBD type and compare healthcare resource utilization in people with IBD, with and without mental health illness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare Resource Utilization - Fitness for Work Notes</measure>
    <time_frame>Measured over five years - 2014 to 2018 inclusive</time_frame>
    <description>Compare healthcare resource utilization in people with and without IBD, and stratifying by IBD type and compare healthcare resource utilization in people with IBD, with and without mental health illness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare Resource Utilization: Medications for Mental Health Conditions - Selective Serotonin Reuptake Inhibitors (SSRIs)</measure>
    <time_frame>Measured over five years - 2014 to 2018 inclusive</time_frame>
    <description>Compare healthcare resource utilization in people with and without IBD, and stratifying by IBD type and compare healthcare resource utilization in people with IBD, with and without mental health illness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare Resource Utilization: Medications for Mental Health Conditions - Anxiolytic Medications</measure>
    <time_frame>Measured over five years - 2014 to 2018 inclusive</time_frame>
    <description>Compare healthcare resource utilization in people with and without IBD, and stratifying by IBD type and compare healthcare resource utilization in people with IBD, with and without mental health illness.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">95055</enrollment>
  <condition>Inflammatory Bowel Diseases</condition>
  <condition>Ulcerative Colitis</condition>
  <condition>Crohn Disease</condition>
  <arm_group>
    <arm_group_label>People with inflammatory bowel disease</arm_group_label>
    <description>Adults (18+) with inflammatory bowel disease registered with a contributing GP practice during the study period</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <description>Adults (18+) without inflammatory bowel disease registered with a contributing GP practice during the study period</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>Observation of routine clinical practice</description>
    <arm_group_label>Controls</arm_group_label>
    <arm_group_label>People with inflammatory bowel disease</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All individuals with an existing or incident diagnosis of UC or CD during the study period&#xD;
        (2013-2018), defined by the presence of at least one disease-specific diagnostic code will&#xD;
        be eligible for inclusion in the IBD cohort. Controls will matched people without IBD&#xD;
        matched on age, gender and primary care practice.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged ≥18 years over the study period&#xD;
&#xD;
          -  Registered with a contributing primary care practice for any duration during the study&#xD;
             period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  IBD not classifiable or of a type other than UC or Crohn's disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew McGovern, MD</last_name>
    <role>Study Director</role>
    <affiliation>Momentum Data Ltd</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Momentum Data Ltd</name>
      <address>
        <city>London</city>
        <zip>WC1X 8QT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <results_first_submitted>October 5, 2021</results_first_submitted>
  <results_first_submitted_qc>December 13, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">January 18, 2023</results_first_posted>
  <last_update_submitted>December 13, 2022</last_update_submitted>
  <last_update_submitted_qc>December 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
    <mesh_term>Intestinal Diseases</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual patient data (IPD) is confidential but can be made available in an anonymised form to bone fide researchers subject to the required data protection training and other requirements. All data will remain behind a firewall and will only be available for access through a secured computer network.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>There is no pre-specified time-frame for data availability; this will be considered on an individual basis for each request.</ipd_time_frame>
    <ipd_access_criteria>As above</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 6, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/12/NCT03836612/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>People With Inflammatory Bowel Disease (Cases)</title>
          <description>Adults (18+) with inflammatory bowel disease registered with a contributing General Practitioner (GP) practice during the study period&#xD;
No intervention: Observation of routine clinical practice</description>
        </group>
        <group group_id="P2">
          <title>People Without Inflammatory Bowel Disease (Controls)</title>
          <description>Adults (18+) without inflammatory bowel disease registered with a contributing GP practice during the study period&#xD;
No intervention: Observation of routine clinical practice</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="19011"/>
                <participants group_id="P2" count="76044"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19011"/>
                <participants group_id="P2" count="76044"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>People With Inflammatory Bowel Disease (Cases)</title>
          <description>Adults (18+) with inflammatory bowel disease registered with a contributing GP practice during the study period&#xD;
No intervention: Observation of routine clinical practice</description>
        </group>
        <group group_id="B2">
          <title>People Without Inflammatory Bowel Disease (Controls)</title>
          <description>Adults (18+) without inflammatory bowel disease registered with a contributing GP practice during the study period&#xD;
No intervention: Observation of routine clinical practice</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="19011"/>
            <count group_id="B2" value="76044"/>
            <count group_id="B3" value="95055"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>18-29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19011"/>
                    <count group_id="B2" value="76044"/>
                    <count group_id="B3" value="95055"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2276"/>
                    <measurement group_id="B2" value="9416"/>
                    <measurement group_id="B3" value="11692"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30-39</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19011"/>
                    <count group_id="B2" value="76044"/>
                    <count group_id="B3" value="95055"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3036"/>
                    <measurement group_id="B2" value="11931"/>
                    <measurement group_id="B3" value="14967"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>40-49</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19011"/>
                    <count group_id="B2" value="76044"/>
                    <count group_id="B3" value="95055"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3379"/>
                    <measurement group_id="B2" value="13593"/>
                    <measurement group_id="B3" value="16972"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50-59</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19011"/>
                    <count group_id="B2" value="76044"/>
                    <count group_id="B3" value="95055"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3560"/>
                    <measurement group_id="B2" value="14305"/>
                    <measurement group_id="B3" value="17865"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60-69</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19011"/>
                    <count group_id="B2" value="76044"/>
                    <count group_id="B3" value="95055"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3235"/>
                    <measurement group_id="B2" value="12890"/>
                    <measurement group_id="B3" value="16125"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>70-79</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19011"/>
                    <count group_id="B2" value="76044"/>
                    <count group_id="B3" value="95055"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2278"/>
                    <measurement group_id="B2" value="8942"/>
                    <measurement group_id="B3" value="11220"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>80+</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19011"/>
                    <count group_id="B2" value="76044"/>
                    <count group_id="B3" value="95055"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1247"/>
                    <measurement group_id="B2" value="4967"/>
                    <measurement group_id="B3" value="6214"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19011"/>
                    <count group_id="B2" value="76044"/>
                    <count group_id="B3" value="95055"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9968"/>
                    <measurement group_id="B2" value="39746"/>
                    <measurement group_id="B3" value="49714"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9043"/>
                    <measurement group_id="B2" value="36298"/>
                    <measurement group_id="B3" value="45341"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United Kingdom</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19011"/>
                    <count group_id="B2" value="76044"/>
                    <count group_id="B3" value="95055"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19011"/>
                    <measurement group_id="B2" value="76044"/>
                    <measurement group_id="B3" value="95055"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19011"/>
                    <count group_id="B2" value="76044"/>
                    <count group_id="B3" value="95055"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Underweight (≤18.5)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7229"/>
                    <measurement group_id="B2" value="24690"/>
                    <measurement group_id="B3" value="31919"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Normal weight (18.5-25)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="639"/>
                    <measurement group_id="B2" value="1814"/>
                    <measurement group_id="B3" value="2453"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Overweight (25-30)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5824"/>
                    <measurement group_id="B2" value="23707"/>
                    <measurement group_id="B3" value="29531"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Obese (≥30)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3775"/>
                    <measurement group_id="B2" value="17379"/>
                    <measurement group_id="B3" value="21154"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not recorded</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1544"/>
                    <measurement group_id="B2" value="8454"/>
                    <measurement group_id="B3" value="9998"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Index of Multiple Deprivation (IMD) quintile</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19011"/>
                    <count group_id="B2" value="76044"/>
                    <count group_id="B3" value="95055"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>1 (most deprived)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2396"/>
                    <measurement group_id="B2" value="9933"/>
                    <measurement group_id="B3" value="12329"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2846"/>
                    <measurement group_id="B2" value="11514"/>
                    <measurement group_id="B3" value="14360"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3617"/>
                    <measurement group_id="B2" value="14720"/>
                    <measurement group_id="B3" value="18337"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4684"/>
                    <measurement group_id="B2" value="18137"/>
                    <measurement group_id="B3" value="22821"/>
                  </measurement_list>
                </category>
                <category>
                  <title>5 (least deprived)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5117"/>
                    <measurement group_id="B2" value="20388"/>
                    <measurement group_id="B3" value="25505"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not recorded</title>
                  <measurement_list>
                    <measurement group_id="B1" value="351"/>
                    <measurement group_id="B2" value="1352"/>
                    <measurement group_id="B3" value="1703"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Comorbidities - Type 2 diabetes</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19011"/>
                    <count group_id="B2" value="76044"/>
                    <count group_id="B3" value="95055"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1665"/>
                    <measurement group_id="B2" value="6336"/>
                    <measurement group_id="B3" value="8001"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Comorbidities - Hypertension</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19011"/>
                    <count group_id="B2" value="76044"/>
                    <count group_id="B3" value="95055"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4249"/>
                    <measurement group_id="B2" value="17591"/>
                    <measurement group_id="B3" value="21840"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Comorbidities - Atrial fibrillation</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19011"/>
                    <count group_id="B2" value="76044"/>
                    <count group_id="B3" value="95055"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="658"/>
                    <measurement group_id="B2" value="2336"/>
                    <measurement group_id="B3" value="2994"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Comorbidities - Angina</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19011"/>
                    <count group_id="B2" value="76044"/>
                    <count group_id="B3" value="95055"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="606"/>
                    <measurement group_id="B2" value="2075"/>
                    <measurement group_id="B3" value="2681"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Comorbidities - Myocardial infarction</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19011"/>
                    <count group_id="B2" value="76044"/>
                    <count group_id="B3" value="95055"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="481"/>
                    <measurement group_id="B2" value="1650"/>
                    <measurement group_id="B3" value="2131"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Comorbidities - Stroke</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19011"/>
                    <count group_id="B2" value="76044"/>
                    <count group_id="B3" value="95055"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="387"/>
                    <measurement group_id="B2" value="1382"/>
                    <measurement group_id="B3" value="1769"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Comorbidities - Heart failure</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19011"/>
                    <count group_id="B2" value="76044"/>
                    <count group_id="B3" value="95055"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="296"/>
                    <measurement group_id="B2" value="1062"/>
                    <measurement group_id="B3" value="1358"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Comorbidities - Chronic liver disease</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19011"/>
                    <count group_id="B2" value="76044"/>
                    <count group_id="B3" value="95055"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="386"/>
                    <measurement group_id="B2" value="487"/>
                    <measurement group_id="B3" value="873"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Comorbidities - Dementia</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19011"/>
                    <count group_id="B2" value="76044"/>
                    <count group_id="B3" value="95055"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="694"/>
                    <measurement group_id="B2" value="2786"/>
                    <measurement group_id="B3" value="3480"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Comorbidities - Rheumatoid arthritis</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19011"/>
                    <count group_id="B2" value="76044"/>
                    <count group_id="B3" value="95055"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="281"/>
                    <measurement group_id="B2" value="706"/>
                    <measurement group_id="B3" value="987"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Comorbidities - Asthma</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19011"/>
                    <count group_id="B2" value="76044"/>
                    <count group_id="B3" value="95055"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3796"/>
                    <measurement group_id="B2" value="12924"/>
                    <measurement group_id="B3" value="16720"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Comorbidities - Chronic Obstructive Pulmonary Disease (COPD)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19011"/>
                    <count group_id="B2" value="76044"/>
                    <count group_id="B3" value="95055"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="982"/>
                    <measurement group_id="B2" value="2990"/>
                    <measurement group_id="B3" value="3972"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Use of systemic therapy</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19011"/>
                    <count group_id="B2" value="76044"/>
                    <count group_id="B3" value="95055"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4183"/>
                    <measurement group_id="B2" value="700"/>
                    <measurement group_id="B3" value="4883"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Prevalence of Anxiety Episodes (Crohn's Disease)</title>
        <description>Compare the prevalence of anxiety episodes in people with and without Crohn's disease.&#xD;
Number of people with at least one anxiety episode in people.</description>
        <time_frame>Measured over five years - 2014 to 2018 inclusive</time_frame>
        <population>Subset of people diagnosed with IBD having Crohn's disease</population>
        <group_list>
          <group group_id="O1">
            <title>People With Crohn's Disease (Cases)</title>
            <description>People aged ≥18, registered with a GP practice contributing to the Oxford-Royal College of General Practitioners Research and Surveillance Centre database (RCGP RSC) between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Crohn's disease.</description>
          </group>
          <group group_id="O2">
            <title>People Without Crohn's Disease (Controls)</title>
            <description>People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 without a history of IBD and matched with an individual with IBD.</description>
          </group>
        </group_list>
        <measure>
          <title>Prevalence of Anxiety Episodes (Crohn's Disease)</title>
          <description>Compare the prevalence of anxiety episodes in people with and without Crohn's disease.&#xD;
Number of people with at least one anxiety episode in people.</description>
          <population>Subset of people diagnosed with IBD having Crohn's disease</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7557"/>
                <count group_id="O2" value="30228"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="262"/>
                    <measurement group_id="O2" value="892"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Prevalence of Anxiety Episodes (Ulcerative Colitis)</title>
        <description>Compare the prevalence of anxiety episodes in people with and without Ulcerative Colitis.&#xD;
Number of people with at least one anxiety episode</description>
        <time_frame>Measured over five years - 2014 to 2018 inclusive</time_frame>
        <population>Subset of people diagnosed with IBD having Ulcerative Colitis</population>
        <group_list>
          <group group_id="O1">
            <title>People With Ulcerative Colitis (Cases)</title>
            <description>People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Ulcerative Colitis.</description>
          </group>
          <group group_id="O2">
            <title>People Without Ulcerative Colitis (Controls)</title>
            <description>People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 without a history of IBD and matched with an individual with IBD.</description>
          </group>
        </group_list>
        <measure>
          <title>Prevalence of Anxiety Episodes (Ulcerative Colitis)</title>
          <description>Compare the prevalence of anxiety episodes in people with and without Ulcerative Colitis.&#xD;
Number of people with at least one anxiety episode</description>
          <population>Subset of people diagnosed with IBD having Ulcerative Colitis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11454"/>
                <count group_id="O2" value="45816"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="341"/>
                    <measurement group_id="O2" value="1221"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Prevalence of Depressive Episodes (Crohn's Disease)</title>
        <description>Compare the prevalence of depressive episodes in people with and without Crohn's disease.&#xD;
Number of people with at least one depressive episode</description>
        <time_frame>Measured over five years - 2014 to 2018 inclusive</time_frame>
        <population>Subset of people diagnosed with IBD having Crohn's disease</population>
        <group_list>
          <group group_id="O1">
            <title>People With Crohn's Disease (Cases)</title>
            <description>People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Crohn's disease.</description>
          </group>
          <group group_id="O2">
            <title>People Without Crohn's Disease (Controls)</title>
            <description>People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 without a history of IBD and matched with an individual with IBD.</description>
          </group>
        </group_list>
        <measure>
          <title>Prevalence of Depressive Episodes (Crohn's Disease)</title>
          <description>Compare the prevalence of depressive episodes in people with and without Crohn's disease.&#xD;
Number of people with at least one depressive episode</description>
          <population>Subset of people diagnosed with IBD having Crohn's disease</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7557"/>
                <count group_id="O2" value="30228"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="431"/>
                    <measurement group_id="O2" value="1233"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Prevalence of Depressive Episodes (Ulcerative Colitis)</title>
        <description>Compare the prevalence of depressive episodes in people with and without Ulcerative Colitis.&#xD;
Number of people with at least one depressive episode.</description>
        <time_frame>Measured over five years - 2014 to 2018 inclusive</time_frame>
        <population>Subset of people diagnosed with IBD having Ulcerative Colitis</population>
        <group_list>
          <group group_id="O1">
            <title>People With Ulcerative Colitis (Cases)</title>
            <description>People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Ulcerative Colitis.</description>
          </group>
          <group group_id="O2">
            <title>People Without Ulcerative Colitis (Controls)</title>
            <description>People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 without a history of IBD and matched with an individual with IBD.</description>
          </group>
        </group_list>
        <measure>
          <title>Prevalence of Depressive Episodes (Ulcerative Colitis)</title>
          <description>Compare the prevalence of depressive episodes in people with and without Ulcerative Colitis.&#xD;
Number of people with at least one depressive episode.</description>
          <population>Subset of people diagnosed with IBD having Ulcerative Colitis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11454"/>
                <count group_id="O2" value="45816"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="507"/>
                    <measurement group_id="O2" value="1666"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of People With Depressive Disorder in People With and Without Crohn's Disease</title>
        <description>Compare the prevalence of depressive disorder in people with and without Crohn's disease.</description>
        <time_frame>Measured over five years - 2014 to 2018 inclusive</time_frame>
        <population>Subset of people diagnosed with IBD having Crohn's disease</population>
        <group_list>
          <group group_id="O1">
            <title>People With Crohn's Disease (Cases)</title>
            <description>People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Crohn's disease.</description>
          </group>
          <group group_id="O2">
            <title>People Without Crohn's Disease (Controls)</title>
            <description>People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 without a history of IBD and matched with an individual with IBD.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of People With Depressive Disorder in People With and Without Crohn's Disease</title>
          <description>Compare the prevalence of depressive disorder in people with and without Crohn's disease.</description>
          <population>Subset of people diagnosed with IBD having Crohn's disease</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7557"/>
                <count group_id="O2" value="30228"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1322"/>
                    <measurement group_id="O2" value="3911"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of People With Depressive Disorder in People With and Without Ulcerative Colitis</title>
        <description>Compare the prevalence of depressive disorder in people with and without Ulcerative Colitis.</description>
        <time_frame>Measured over five years - 2014 to 2018 inclusive</time_frame>
        <population>Subset of people diagnosed with IBD having Ulcerative colitis</population>
        <group_list>
          <group group_id="O1">
            <title>People With Ulcerative Colitis (Cases)</title>
            <description>People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Ulcerative Colitis.</description>
          </group>
          <group group_id="O2">
            <title>People Without Ulcerative Colitis (Controls)</title>
            <description>People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 without a history of IBD and matched with an individual with IBD.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of People With Depressive Disorder in People With and Without Ulcerative Colitis</title>
          <description>Compare the prevalence of depressive disorder in people with and without Ulcerative Colitis.</description>
          <population>Subset of people diagnosed with IBD having Ulcerative colitis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11454"/>
                <count group_id="O2" value="45816"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1627"/>
                    <measurement group_id="O2" value="5676"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of People With at Least One Infection Event in Those With and Without Ulcerative Colitis</title>
        <description>Number of people with at least one infection event during follow up for any common infection, gastrointestinal infection, and any viral infection.</description>
        <time_frame>Measured over 5 years - 2014 to 2018 inclusive</time_frame>
        <group_list>
          <group group_id="O1">
            <title>People With Ulcerative Colitis (Common Infections Cases)</title>
            <description>People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Ulcerative Colitis.</description>
          </group>
          <group group_id="O2">
            <title>People Without Ulcerative Colitis (Common Infections Controls)</title>
            <description>People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 without a history of Ulcerative Colitis and matched with an individual with Ulcerative Colitis.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of People With at Least One Infection Event in Those With and Without Ulcerative Colitis</title>
          <description>Number of people with at least one infection event during follow up for any common infection, gastrointestinal infection, and any viral infection.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11360"/>
                <count group_id="O2" value="45440"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any common infection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5111"/>
                    <measurement group_id="O2" value="17403"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gastrointestinal infection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="510"/>
                    <measurement group_id="O2" value="1365"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Viral infection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2544"/>
                    <measurement group_id="O2" value="8510"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of People With at Least One Infection Event in Those With and Without Crohn's Disease</title>
        <description>Number of people with at least one infection event during follow up for any common infection, gastrointestinal infection, and any viral infection.</description>
        <time_frame>Measured over 5 years - 2014 to 2019 inclusive</time_frame>
        <group_list>
          <group group_id="O1">
            <title>People With Crohn's Disease (Common Infections Cases)</title>
            <description>People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Crohn's disease.</description>
          </group>
          <group group_id="O2">
            <title>People Without Crohn's Disease (Common Infections Controls)</title>
            <description>People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 without a history of Crohn's disease and matched with an individual with Crohn's disease.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of People With at Least One Infection Event in Those With and Without Crohn's Disease</title>
          <description>Number of people with at least one infection event during follow up for any common infection, gastrointestinal infection, and any viral infection.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7469"/>
                <count group_id="O2" value="29876"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any common infection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3470"/>
                    <measurement group_id="O2" value="11227"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gastrointestinal infection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="395"/>
                    <measurement group_id="O2" value="841"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Viral infection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1797"/>
                    <measurement group_id="O2" value="5917"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of People With at Least One Sub-infection Event in Those With and Without Ulcerative Colitis</title>
        <description>Sub-infection outcomes: Upper respiratory tract infection (URTI), Pneumonia, Acute Bronchitis, Influenza, Skin infection, Genital infection, urinary tract infection (UTI), GI infection subset (only stool culture confirmed Clostridium difficile, Salmonella, Shigella, and Campylobacter infections), Herpes Simplex infection, Herpes Zoster infection</description>
        <time_frame>Measured over 5 years - 2014 to 2019 inclusive</time_frame>
        <group_list>
          <group group_id="O1">
            <title>People With Ulcerative Colitis (Common Infections Cases)</title>
            <description>People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Ulcerative Colitis.</description>
          </group>
          <group group_id="O2">
            <title>People Without Ulcerative Colitis (Common Infections Controls)</title>
            <description>People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 without a history of Ulcerative Colitis and matched with an individual with Ulcerative Colitis.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of People With at Least One Sub-infection Event in Those With and Without Ulcerative Colitis</title>
          <description>Sub-infection outcomes: Upper respiratory tract infection (URTI), Pneumonia, Acute Bronchitis, Influenza, Skin infection, Genital infection, urinary tract infection (UTI), GI infection subset (only stool culture confirmed Clostridium difficile, Salmonella, Shigella, and Campylobacter infections), Herpes Simplex infection, Herpes Zoster infection</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11360"/>
                <count group_id="O2" value="45440"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>URTI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2118"/>
                    <measurement group_id="O2" value="7143"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pneumonia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="288"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Acute Bronchitis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1754"/>
                    <measurement group_id="O2" value="5554"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Influenza</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="234"/>
                    <measurement group_id="O2" value="856"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Skin infections</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1654"/>
                    <measurement group_id="O2" value="5268"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genital infection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="246"/>
                    <measurement group_id="O2" value="874"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>UTI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="733"/>
                    <measurement group_id="O2" value="2631"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GI infection subset</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="121"/>
                    <measurement group_id="O2" value="198"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Herpes Simplex infection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="106"/>
                    <measurement group_id="O2" value="352"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Herpes Zoster infection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="309"/>
                    <measurement group_id="O2" value="839"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Healthcare Resource Utilization - Primary Care Visits</title>
        <description>Compare healthcare resource utilization in people with and without IBD, and stratifying by IBD type and compare healthcare resource utilization in people with IBD, with and without mental health illness.</description>
        <time_frame>Measured over five years - 2014 to 2018 inclusive</time_frame>
        <population>The arm/Groups titled people with ulcerative colitis and people with Crohn's disease are subsets of the arm/Group titled people with IBD</population>
        <group_list>
          <group group_id="O1">
            <title>People With IBD</title>
            <description>People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Crohn's disease or ulcerative colitis.</description>
          </group>
          <group group_id="O2">
            <title>People With Ulcerative Colitis</title>
            <description>People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of ulcerative colitis.</description>
          </group>
          <group group_id="O3">
            <title>People With Crohn's Disease</title>
            <description>People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Crohn's disease.</description>
          </group>
          <group group_id="O4">
            <title>People Without IBD</title>
            <description>People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 without a history of IBD.</description>
          </group>
        </group_list>
        <measure>
          <title>Healthcare Resource Utilization - Primary Care Visits</title>
          <description>Compare healthcare resource utilization in people with and without IBD, and stratifying by IBD type and compare healthcare resource utilization in people with IBD, with and without mental health illness.</description>
          <population>The arm/Groups titled people with ulcerative colitis and people with Crohn's disease are subsets of the arm/Group titled people with IBD</population>
          <units>Visits per person per year</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19011"/>
                <count group_id="O2" value="11454"/>
                <count group_id="O3" value="7557"/>
                <count group_id="O4" value="76044"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.41" lower_limit="6.39" upper_limit="6.44"/>
                    <measurement group_id="O2" value="6.18" lower_limit="6.15" upper_limit="6.20"/>
                    <measurement group_id="O3" value="6.78" lower_limit="6.75" upper_limit="6.82"/>
                    <measurement group_id="O4" value="4.49" lower_limit="4.48" upper_limit="4.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Healthcare Resource Utilization - Secondary Care Emergency Attendances</title>
        <description>Compare healthcare resource utilization in people with and without IBD, and stratifying by IBD type and compare healthcare resource utilization in people with IBD, with and without mental health illness.</description>
        <time_frame>Measured over five years - 2014 to 2018 inclusive</time_frame>
        <population>The arm/Groups titled people with ulcerative colitis and people with Crohn's disease are subsets of the arm/Group titled people with IBD</population>
        <group_list>
          <group group_id="O1">
            <title>People With IBD</title>
            <description>People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Crohn's disease or ulcerative colitis.</description>
          </group>
          <group group_id="O2">
            <title>People With Ulcerative Colitis</title>
            <description>People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of ulcerative colitis.</description>
          </group>
          <group group_id="O3">
            <title>People With Crohn's Disease</title>
            <description>People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Crohn's disease.</description>
          </group>
          <group group_id="O4">
            <title>People Without IBD</title>
            <description>People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 without a history of IBD.</description>
          </group>
        </group_list>
        <measure>
          <title>Healthcare Resource Utilization - Secondary Care Emergency Attendances</title>
          <description>Compare healthcare resource utilization in people with and without IBD, and stratifying by IBD type and compare healthcare resource utilization in people with IBD, with and without mental health illness.</description>
          <population>The arm/Groups titled people with ulcerative colitis and people with Crohn's disease are subsets of the arm/Group titled people with IBD</population>
          <units>Attendances per person per year</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19011"/>
                <count group_id="O2" value="11454"/>
                <count group_id="O3" value="7557"/>
                <count group_id="O4" value="76044"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.455" lower_limit="0.449" upper_limit="0.461"/>
                    <measurement group_id="O2" value="0.396" lower_limit="0.389" upper_limit="0.403"/>
                    <measurement group_id="O3" value="0.546" lower_limit="0.536" upper_limit="0.557"/>
                    <measurement group_id="O4" value="0.259" lower_limit="0.257" upper_limit="0.262"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Healthcare Resource Utilization - Fitness for Work Notes</title>
        <description>Compare healthcare resource utilization in people with and without IBD, and stratifying by IBD type and compare healthcare resource utilization in people with IBD, with and without mental health illness.</description>
        <time_frame>Measured over five years - 2014 to 2018 inclusive</time_frame>
        <population>The arm/Groups titled people with ulcerative colitis and people with Crohn's disease are subsets of the arm/Group titled people with IBD</population>
        <group_list>
          <group group_id="O1">
            <title>People With IBD</title>
            <description>People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Crohn's disease or ulcerative colitis.</description>
          </group>
          <group group_id="O2">
            <title>People With Ulcerative Colitis</title>
            <description>People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of ulcerative colitis.</description>
          </group>
          <group group_id="O3">
            <title>People With Crohn's Disease</title>
            <description>People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Crohn's disease.</description>
          </group>
          <group group_id="O4">
            <title>People Without IBD</title>
            <description>People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 without a history of IBD.</description>
          </group>
        </group_list>
        <measure>
          <title>Healthcare Resource Utilization - Fitness for Work Notes</title>
          <description>Compare healthcare resource utilization in people with and without IBD, and stratifying by IBD type and compare healthcare resource utilization in people with IBD, with and without mental health illness.</description>
          <population>The arm/Groups titled people with ulcerative colitis and people with Crohn's disease are subsets of the arm/Group titled people with IBD</population>
          <units>Notes issued per person per year</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19011"/>
                <count group_id="O2" value="11454"/>
                <count group_id="O3" value="7557"/>
                <count group_id="O4" value="76044"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.311" lower_limit="0.306" upper_limit="0.316"/>
                    <measurement group_id="O2" value="0.270" lower_limit="0.265" upper_limit="0.276"/>
                    <measurement group_id="O3" value="0.378" lower_limit="0.368" upper_limit="0.386"/>
                    <measurement group_id="O4" value="0.215" lower_limit="0.213" upper_limit="0.217"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Healthcare Resource Utilization: Medications for Mental Health Conditions - Selective Serotonin Reuptake Inhibitors (SSRIs)</title>
        <description>Compare healthcare resource utilization in people with and without IBD, and stratifying by IBD type and compare healthcare resource utilization in people with IBD, with and without mental health illness.</description>
        <time_frame>Measured over five years - 2014 to 2018 inclusive</time_frame>
        <population>The arm/Groups titled people with ulcerative colitis and people with Crohn's disease are subsets of the arm/Group titled people with IBD</population>
        <group_list>
          <group group_id="O1">
            <title>People With IBD</title>
            <description>People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Crohn's disease or ulcerative colitis.</description>
          </group>
          <group group_id="O2">
            <title>People With Ulcerative Colitis</title>
            <description>People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of ulcerative colitis.</description>
          </group>
          <group group_id="O3">
            <title>People With Crohn's Disease</title>
            <description>People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Crohn's disease.</description>
          </group>
          <group group_id="O4">
            <title>People Without IBD</title>
            <description>People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 without a history of IBD.</description>
          </group>
        </group_list>
        <measure>
          <title>Healthcare Resource Utilization: Medications for Mental Health Conditions - Selective Serotonin Reuptake Inhibitors (SSRIs)</title>
          <description>Compare healthcare resource utilization in people with and without IBD, and stratifying by IBD type and compare healthcare resource utilization in people with IBD, with and without mental health illness.</description>
          <population>The arm/Groups titled people with ulcerative colitis and people with Crohn's disease are subsets of the arm/Group titled people with IBD</population>
          <units>Prescriptions per person per year</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19011"/>
                <count group_id="O2" value="11454"/>
                <count group_id="O3" value="7557"/>
                <count group_id="O4" value="76044"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.328" lower_limit="1.317" upper_limit="1.338"/>
                    <measurement group_id="O2" value="1.218" lower_limit="1.205" upper_limit="1.230"/>
                    <measurement group_id="O3" value="1.495" lower_limit="1.478" upper_limit="1.512"/>
                    <measurement group_id="O4" value="1.046" lower_limit="1.041" upper_limit="1.050"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Healthcare Resource Utilization: Medications for Mental Health Conditions - Anxiolytic Medications</title>
        <description>Compare healthcare resource utilization in people with and without IBD, and stratifying by IBD type and compare healthcare resource utilization in people with IBD, with and without mental health illness.</description>
        <time_frame>Measured over five years - 2014 to 2018 inclusive</time_frame>
        <population>The arm/Groups titled people with ulcerative colitis and people with Crohn's disease are subsets of the arm/Group titled people with IBD</population>
        <group_list>
          <group group_id="O1">
            <title>People With IBD</title>
            <description>People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Crohn's disease or ulcerative colitis.</description>
          </group>
          <group group_id="O2">
            <title>People With Ulcerative Colitis</title>
            <description>People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of ulcerative colitis.</description>
          </group>
          <group group_id="O3">
            <title>People With Crohn's Disease</title>
            <description>People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Crohn's disease.</description>
          </group>
          <group group_id="O4">
            <title>People Without IBD</title>
            <description>People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 without a history of IBD.</description>
          </group>
        </group_list>
        <measure>
          <title>Healthcare Resource Utilization: Medications for Mental Health Conditions - Anxiolytic Medications</title>
          <description>Compare healthcare resource utilization in people with and without IBD, and stratifying by IBD type and compare healthcare resource utilization in people with IBD, with and without mental health illness.</description>
          <population>The arm/Groups titled people with ulcerative colitis and people with Crohn's disease are subsets of the arm/Group titled people with IBD</population>
          <units>Prescriptions per person per year</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19011"/>
                <count group_id="O2" value="11454"/>
                <count group_id="O3" value="7557"/>
                <count group_id="O4" value="76044"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.219" lower_limit="0.214" upper_limit="0.223"/>
                    <measurement group_id="O2" value="0.189" lower_limit="0.183" upper_limit="0.194"/>
                    <measurement group_id="O3" value="0.264" lower_limit="0.257" upper_limit="0.272"/>
                    <measurement group_id="O4" value="0.166" lower_limit="0.164" upper_limit="0.168"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of People With at Least One Sub-infection Event in Those With and Without Crohn's Disease</title>
        <description>Sub-infection outcomes: URTI, Pneumonia, Acute Bronchitis, Influenza, Skin infection, Genital infection, UTI, GI infection subset (only stool culture confirmed Clostridium difficile, Salmonella, Shigella, and Campylobacter infections), Herpes Simplex infection, Herpes Zoster infection</description>
        <time_frame>Measured over 5 years - 2014 to 2019 inclusive</time_frame>
        <group_list>
          <group group_id="O1">
            <title>People With Crohn's Disease (Common Infections Cases)</title>
            <description>People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Crohn's disease.</description>
          </group>
          <group group_id="O2">
            <title>People Without Crohn's Disease (Common Infections Controls)</title>
            <description>People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 without a history of Crohn's disease and matched with an individual with Crohn's disease.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of People With at Least One Sub-infection Event in Those With and Without Crohn's Disease</title>
          <description>Sub-infection outcomes: URTI, Pneumonia, Acute Bronchitis, Influenza, Skin infection, Genital infection, UTI, GI infection subset (only stool culture confirmed Clostridium difficile, Salmonella, Shigella, and Campylobacter infections), Herpes Simplex infection, Herpes Zoster infection</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7469"/>
                <count group_id="O2" value="29876"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>URTI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1475"/>
                    <measurement group_id="O2" value="5002"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pneumonia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59"/>
                    <measurement group_id="O2" value="136"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Acute Bronchitis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1059"/>
                    <measurement group_id="O2" value="3211"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Influenza</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="158"/>
                    <measurement group_id="O2" value="621"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Skin infections</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1201"/>
                    <measurement group_id="O2" value="3294"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genital infection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="219"/>
                    <measurement group_id="O2" value="665"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>UTI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="473"/>
                    <measurement group_id="O2" value="1568"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GI infection subset</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76"/>
                    <measurement group_id="O2" value="130"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Herpes Simplex infection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="109"/>
                    <measurement group_id="O2" value="253"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Herpes Zoster infection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="237"/>
                    <measurement group_id="O2" value="491"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>Death, serious adverse events and other (non-serious adverse events) were not assessed for the study.</desc>
      <group_list>
        <group group_id="E1">
          <title>People With Inflammatory Bowel Disease (Cases)</title>
          <description>Adults (18+) with inflammatory bowel disease registered with a contributing GP practice during the study period&#xD;
No intervention: Observation of routine clinical practice</description>
        </group>
        <group group_id="E2">
          <title>People Without Inflammatory Bowel Disease (Controls)</title>
          <description>Adults (18+) without inflammatory bowel disease registered with a contributing GP practice during the study period&#xD;
No intervention: Observation of routine clinical practice</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Peter Irving</name_or_title>
      <organization>St Thomas' Hospital, London</organization>
      <phone>020 7188 7188</phone>
      <email>peter.irving@gstt.nhs.uk</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03836612
org study id: P003
nct id: NCT03836612
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Ulcerative colitis and Crohn's disease are the commonest types of inflammatory bowel disease
      (IBD). Both conditions range in severity from no symptoms to being potentially fatal. Both
      conditions are treated with medications which suppress the immune system. It is not known
      whether this increases the risk for infections and cancers in these conditions. It is also
      recognised by healthcare professionals that these conditions cause a considerable amount of
      psychological distress. However, this has never been measured in a large population sample.

      This study will investigate any associations with treatment and new onset infections and
      cancer. They will also examine the relationship between IBD and common mental health problems
      (specifically, depression and anxiety) and the impact that these have on the healthcare use
      (including number of general practitioner [GP] appointments, hospital attendances, and
      medication prescriptions. Combined, these studies should provide a better understanding of
      the impact of IBD on affected people and provide evidence to support the correct allocation
      of healthcare resources.
Objective We aim to provide an accurate and contemporary measurement of the current
      healthcare resource utilisation in people with inflammatory bowel disease (IBD); namely
      ulcerative colitis (UC) and Crohn's disease (CD). We also aim to provide estimates of
      infection incidence in this population and the prevalence of common mental health conditions.

      Method We will identify UC and CD using algorithms validated for accurately identifying these
      conditions from primary care records in the United Kingdom (UK). We will identify a prevalent
      cohort of adults with IBD with the Royal College of General Practitioners (RCGP) Research and
      Surveillance Centre (RSC) network over the last decade. We will identify a matched cohort of
      people without IBD; matched on age, gender and primary care practice. Across these cohorts we
      will compare healthcare resource utilisation (primary care attendances, number of primary
      care prescriptions for antidepressant and anxiolytic medications, number of primary care
      prescriptions for medications used in IBD, recorded secondary care attendances, and issue of
      statements of fitness for work), incident infections (any common infection, any viral
      infection, or any gastrointestinal infection), and common mental health conditions
      (depression and anxiety).
observational model: Cohort
time perspective: Retrospective
measure: Prevalence of Anxiety Episodes (Crohn's Disease)
time frame: Measured over five years - 2014 to 2018 inclusive
description: Compare the prevalence of anxiety episodes in people with and without Crohn's disease.
Number of people with at least one anxiety episode in people.
measure: Prevalence of Anxiety Episodes (Ulcerative Colitis)
time frame: Measured over five years - 2014 to 2018 inclusive
description: Compare the prevalence of anxiety episodes in people with and without Ulcerative Colitis.
Number of people with at least one anxiety episode
measure: Prevalence of Depressive Episodes (Crohn's Disease)
time frame: Measured over five years - 2014 to 2018 inclusive
description: Compare the prevalence of depressive episodes in people with and without Crohn's disease.
Number of people with at least one depressive episode
measure: Prevalence of Depressive Episodes (Ulcerative Colitis)
time frame: Measured over five years - 2014 to 2018 inclusive
description: Compare the prevalence of depressive episodes in people with and without Ulcerative Colitis.
Number of people with at least one depressive episode.
measure: Number of People With Depressive Disorder in People With and Without Crohn's Disease
time frame: Measured over five years - 2014 to 2018 inclusive
description: Compare the prevalence of depressive disorder in people with and without Crohn's disease.
measure: Number of People With Depressive Disorder in People With and Without Ulcerative Colitis
time frame: Measured over five years - 2014 to 2018 inclusive
description: Compare the prevalence of depressive disorder in people with and without Ulcerative Colitis.
measure: Number of People With at Least One Infection Event in Those With and Without Ulcerative Colitis
time frame: Measured over 5 years - 2014 to 2018 inclusive
description: Number of people with at least one infection event during follow up for any common infection, gastrointestinal infection, and any viral infection.
measure: Number of People With at Least One Infection Event in Those With and Without Crohn's Disease
time frame: Measured over 5 years - 2014 to 2019 inclusive
description: Number of people with at least one infection event during follow up for any common infection, gastrointestinal infection, and any viral infection.
measure: Number of People With at Least One Sub-infection Event in Those With and Without Ulcerative Colitis
time frame: Measured over 5 years - 2014 to 2019 inclusive
description: Sub-infection outcomes: Upper respiratory tract infection (URTI), Pneumonia, Acute Bronchitis, Influenza, Skin infection, Genital infection, urinary tract infection (UTI), GI infection subset (only stool culture confirmed Clostridium difficile, Salmonella, Shigella, and Campylobacter infections), Herpes Simplex infection, Herpes Zoster infection
measure: Number of People With at Least One Sub-infection Event in Those With and Without Crohn's Disease
time frame: Measured over 5 years - 2014 to 2019 inclusive
description: Sub-infection outcomes: URTI, Pneumonia, Acute Bronchitis, Influenza, Skin infection, Genital infection, UTI, GI infection subset (only stool culture confirmed Clostridium difficile, Salmonella, Shigella, and Campylobacter infections), Herpes Simplex infection, Herpes Zoster infection
measure: Healthcare Resource Utilization - Primary Care Visits
time frame: Measured over five years - 2014 to 2018 inclusive
description: Compare healthcare resource utilization in people with and without IBD, and stratifying by IBD type and compare healthcare resource utilization in people with IBD, with and without mental health illness.
measure: Healthcare Resource Utilization - Secondary Care Emergency Attendances
time frame: Measured over five years - 2014 to 2018 inclusive
description: Compare healthcare resource utilization in people with and without IBD, and stratifying by IBD type and compare healthcare resource utilization in people with IBD, with and without mental health illness.
measure: Healthcare Resource Utilization - Fitness for Work Notes
time frame: Measured over five years - 2014 to 2018 inclusive
description: Compare healthcare resource utilization in people with and without IBD, and stratifying by IBD type and compare healthcare resource utilization in people with IBD, with and without mental health illness.
measure: Healthcare Resource Utilization: Medications for Mental Health Conditions - Selective Serotonin Reuptake Inhibitors (SSRIs)
time frame: Measured over five years - 2014 to 2018 inclusive
description: Compare healthcare resource utilization in people with and without IBD, and stratifying by IBD type and compare healthcare resource utilization in people with IBD, with and without mental health illness.
measure: Healthcare Resource Utilization: Medications for Mental Health Conditions - Anxiolytic Medications
time frame: Measured over five years - 2014 to 2018 inclusive
description: Compare healthcare resource utilization in people with and without IBD, and stratifying by IBD type and compare healthcare resource utilization in people with IBD, with and without mental health illness.
arm group label: People with inflammatory bowel disease
description: Adults (18+) with inflammatory bowel disease registered with a contributing GP practice during the study period
arm group label: Controls
description: Adults (18+) without inflammatory bowel disease registered with a contributing GP practice during the study period
intervention type: Other
intervention name: No intervention
description: Observation of routine clinical practice
arm group label: Controls
arm group label: People with inflammatory bowel disease
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Andrew McGovern, MD
role: Study Director
affiliation: Momentum Data Ltd
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Crohn Disease
mesh term: Intestinal Diseases
mesh term: Inflammatory Bowel Diseases
sharing ipd: Yes
ipd description: Individual patient data (IPD) is confidential but can be made available in an anonymised form to bone fide researchers subject to the required data protection training and other requirements. All data will remain behind a firewall and will only be available for access through a secured computer network.
ipd info type: Study Protocol
ipd time frame: There is no pre-specified time-frame for data availability; this will be considered on an individual basis for each request.
ipd access criteria: As above
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 