<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/NCT02970422</url>
  </required_header>
  <id_info>
    <org_study_id>15-203-MUHC</org_study_id>
    <nct_id>NCT02970422</nct_id>
  </id_info>
  <brief_title>Chronic Obstructive Pulmonary Disease Patient Preferences Survey</brief_title>
  <official_title>COPD Patient Preferences, Activities, and Participation Survey</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McGill University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>McGill University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to distribute a questionnaire created for individuals living&#xD;
      with chronic obstructive pulmonary disease (COPD) to assess their activities, participation,&#xD;
      and healthcare and COPD-related research priorities. The data collected will be compared&#xD;
      across diagnosed COPD stages and disease severity to determine the extent to which adults&#xD;
      with COPD participate in the listed activities and identify their primary research and&#xD;
      healthcare related priorities. The questionnaire was originally developed based on past&#xD;
      research then verified by a panel of COPD and participation experts; as well as, individuals&#xD;
      living with COPD in the form of focus groups. The questionnaire will now be administered to&#xD;
      200 individuals living COPD (50 in each GOLD stage) at three sites across Montreal where&#xD;
      clinical data for each participant will be available. This phase will help establish the&#xD;
      reliability of the questionnaire.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">December 12, 2018</completion_date>
  <primary_completion_date type="Actual">October 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Who Prioritized Healthcare Topics</measure>
    <time_frame>Baseline</time_frame>
    <description>Twenty-four healthcare topics were selected once again from a literature and expert panel review, as well as corroborated by individuals living with COPD in five focus groups. Example healthcare topics include: relief of breathlessness; increase maximal amount of exercise individuals living with COPD can do inside and outside their homes; and prevent-lung flare-ups. Participants were asked to indicate their preference of the topics by assigning a percentage of their time, in increments of 10%, to the various healthcare topics, for a total of 100% of their time. For the 24 healthcare topics, individuals could select up to 10 topics (10% times 10 topics, for 100% of their time). The top five topics are presented as the most important topics for the participants and are indicative of areas of focus for future healthcare and research. The top five were presented in accordance to the request from the working group who developed the survey and reviewed the results.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Prioritized Research Topics</measure>
    <time_frame>Baseline</time_frame>
    <description>Individuals were asked to indicate their research priorities from a list of research topics using a modified willingness-to-pay method (Kawata et al., 2014). The willingness-to-pay method allows individuals to assign preference to various topics by assigning a percentage of funds to the topic. A list of 22 research topics (e.g., to relieve breathlessness in individuals living with COPD, to increase access to lung transplantations) was created for this study through a literature review, expert consultation, and five focus groups with individuals living with COPD (n=23, 27% women). Individuals were asked to assign a percentage of funds, in increments of 10% of funding, to the 22 COPD research topics. Participants could assign anywhere between 10% of funding to 100% of funding to the topics. The top five were presented in accordance to the request from the working group who developed the survey and reviewed the results.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Were Not Satisfied With Their Participation in Daily and Social Activities</measure>
    <time_frame>Baseline</time_frame>
    <description>Participants will answer questions about their participation in 26 daily activities, as well as their desire to participate in each of the 26 daily activities. This is a measure of those who indicated they wanted to increase their participation. 10 of the 26 activities and their outcome measures are listed below.&#xD;
Activity 1: Walking from one place to another outside of your home on a flat surface.&#xD;
Activity 2: Moving from one place to another using motorized transportation.&#xD;
Activity 3: Climbing two or more flights of stairs.&#xD;
Activity 4: Walking up a hill.&#xD;
Activity 5: Participating in regular exercise.&#xD;
Activity 6: Walking from one place to another in your home.&#xD;
Activity 7: Carrying light objects on a flat surface.&#xD;
Activity 8: Carrying heavy objects on a flat surface.&#xD;
Activity 9: Carrying-out low intensity physical activities</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Forced Expiratory Volume in 1-sec (FEV1)</measure>
    <time_frame>Baseline</time_frame>
    <description>Individuals forced expiratory volume in 1-sec (FEV1) as assessed by spirometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FEV1/FVC</measure>
    <time_frame>Baseline</time_frame>
    <description>Individuals FEV1-to-forced vital capacity (FVC) ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Medical Research Council Questionnaire on Breathlessness</measure>
    <time_frame>Baseline</time_frame>
    <description>Self-reported intensity of activity related breathlessness as assessed by the modified Medical Research Council (mMRC) dyspnea scale (0-4). This questionnaire was used to measure participants' breathlessness burden using a single item scale from 0 to 4, where a score of 0-1 indicated mild breathlessness and 2-4 indicated increased breathlessness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>COPD Assessment Test</measure>
    <time_frame>Baseline</time_frame>
    <description>This questionnaire measure the impact COPD is having on well being and daily life. The CAT is an eight-item semantic differential scale from 0 to 5, where 0 is no impact and 5 is extremely impactful. Items include: I never cough| I cough all the time, I have no phlegm (mucus) in my chest at all | My chest is completely full of phlegm (mucus), My chest does not feel tight at all | My chest feels very tight, When I walk up a hill or one flight of stairs, I am not breathless | When I walk up a hill or one flight of stairs, I am very breathless, I am not limited doing any activities at home| I am very limited doing activities at home, I am confident leaving my home despite my lung condition| I am not at all confident leaving my home because of my lung condition, I sleep soundly | I don't sleep soundly because of my lung condition, I have lots of energy I have no energy at all. Participants' scores were totaled and a score of ≥ 10 indicated higher than normal burden of disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Godin Leisure Time Physical Activity Questionnaire</measure>
    <time_frame>Baseline</time_frame>
    <description>Self-reported physical activity levels measured in length of bouts over the previous 7 days to determine physical activity frequency.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction of Life Questionnaire</measure>
    <time_frame>Baseline</time_frame>
    <description>This 5 item questionnaire was used to measure participants' level of life satisfaction. The higher the score, the higher the sense of life satisfaction. A score from 5-9 indicated extremely dissatisfied, 10-14 is dissatisfied, 15-19 indicated slightly below average life satisfaction. 20-24 is the average score, 25-29 is a high score indicative of higher life satisfaction and a score between 30-35 is a very high score and represent very high life satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Exacerbations Due to COPD in the Preceding 12 Months</measure>
    <time_frame>baseline</time_frame>
    <description>An exacerbation was defined as a change in medication due to a COPD exacerbation (i.e., the prescription of prednisone or a medical action plan) as indicated in the medical chart or hospital admission due to a COPD exacerbation.</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">200</enrollment>
  <condition>Pulmonary Disease, Chronic Obstructive</condition>
  <arm_group>
    <arm_group_label>Quartile 1 [Mild]</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Quartile 2 [Moderate]</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Quartile 3 [Severe]</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Quartile 4 [Very Severe]</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patient Survey</intervention_name>
    <description>Participants will answer an online survey and their medical chart information will be gathered to compare responses across disease severity.</description>
    <arm_group_label>Quartile 1 [Mild]</arm_group_label>
    <arm_group_label>Quartile 2 [Moderate]</arm_group_label>
    <arm_group_label>Quartile 3 [Severe]</arm_group_label>
    <arm_group_label>Quartile 4 [Very Severe]</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adults living with chronic obstructive pulmonary disease (COPD).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of COPD&#xD;
&#xD;
          -  English or French speaking&#xD;
&#xD;
          -  Patient at one of the three participating sites with medical chart&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No diagnosis of COPD by a healthcare professional&#xD;
&#xD;
          -  Unable to communicate in English or French&#xD;
&#xD;
          -  Unable to provide informed consent&#xD;
&#xD;
          -  No medical chart information at one of the three participating sites&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dennis Jensen, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>McGill University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shane N Sweet, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>McGill University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Montreal Chest Institute of the McGill University Health Center (MUHC)</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4A 3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>http://www.mcgill.ca/cerpl/</url>
    <description>Clinical Exercise and Respiratory Physiology Laboratory (CERPL)</description>
  </link>
  <link>
    <url>http://exercisepsych.research.mcgill.ca/</url>
    <description>Theories and Interventions in Exercise and Health Psychology (TIE) Laboratory</description>
  </link>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>April 26, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <results_first_submitted>August 11, 2020</results_first_submitted>
  <results_first_submitted_qc>December 1, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">December 24, 2020</results_first_posted>
  <last_update_submitted>December 1, 2020</last_update_submitted>
  <last_update_submitted_qc>December 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McGill University</investigator_affiliation>
    <investigator_full_name>Dennis Jensen, Ph.D.</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Survey</keyword>
  <keyword>Priorities</keyword>
  <keyword>Activities</keyword>
  <keyword>Participation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 12, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT02970422/ICF_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 12, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT02970422/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 13, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT02970422/SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>200 participants completed the AHRPQ. Of those, 52 were missing spirometry in medical records, 148 completed with spirometry for Quartile 1-4 analysis [groups], and 130 of the 148 completed spirometry, exacerbation and mMRC for Group A-D analysis.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>All Participants</title>
          <description>Participants answered an online survey and their medical chart information was gathered to compare responses across disease severity. This was a single arm study.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="200"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="200"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>All Participants</title>
          <description>Participants answered an online survey and their medical chart information was gathered to compare responses across disease severity. This was a single arm study.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="200"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="200"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.5" spread="8.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>Participants were missing data as data collected was voluntary to provide or the information was not included in their medical charts.</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="199"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="96"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <population>Participants were missing data as data collected was voluntary to provide or the information was not included in their medical charts.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="193"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="181"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Canada</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="200"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="200"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Marital Status</title>
          <population>Participants were missing data as data collected was voluntary to provide or the information was not included in their medical charts.</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="194"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Single/Divorced/Widowed</title>
                  <measurement_list>
                    <measurement group_id="B1" value="86"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Married/Common Law</title>
                  <measurement_list>
                    <measurement group_id="B1" value="108"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education</title>
          <population>Participants were missing data as data collected was voluntary to provide or the information was not included in their medical charts.</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="194"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Full-time/Part-time</title>
                  <measurement_list>
                    <measurement group_id="B1" value="86"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unemployed/Retired/Disability</title>
                  <measurement_list>
                    <measurement group_id="B1" value="108"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Household Income</title>
          <population>Participants were missing data as data collected was voluntary to provide or the information was not included in their medical charts.</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="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Under $60,000</title>
                  <measurement_list>
                    <measurement group_id="B1" value="118"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Above $60,000</title>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Smoking</title>
          <population>Participants were missing data as data collected was voluntary to provide or the information was not included in their medical charts.</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="193"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Never smoked tobacco</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ever smoked tobacco</title>
                  <measurement_list>
                    <measurement group_id="B1" value="184"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>CAT (COPD assessment test)</title>
          <description>This questionnaire helps measure the impact COPD is having on well being and daily life. The CAT is an eight-item semantic differential scale from 0 to 5, where 0 is no impact and 5 is extremely impactful. Individuals are asked to rate the impact of 8 items on their COPD disease burden. Their total score is calculated. A score of &lt;10 is representative of lower disease burden; whereas, a score &gt;= 10 is indicative of higher disease burden.</description>
          <population>Participants were missing data as data collected was voluntary to provide or the information was not included in their medical charts.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>score &lt;10 (less than normal burden of disease)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="197"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>score ≥10 (higher than normal burden of disease )</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="200"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="163"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>mMRC (Modified-Medical Research Council Questionnaire on breathlessness)</title>
          <description>This questionnaire was used to measure participants' breathlessness burden using a single item scale from 0 to 4, where a score of 0-1 indicated mild breathlessness and 2-4 indicated increased breathlessness.</description>
          <population>Participants were missing data as data collected was voluntary to provide or the information was not included in their medical charts.</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="196"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>0-1 (mild breathlessnes)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥2 (increased breathlessness)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="129"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pulmonary Rehab Attendance</title>
          <population>Participants were missing data as data collected was voluntary to provide or the information was not included in their medical charts.</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="193"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="81"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="112"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>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="200"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Congestive 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="200"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Peripheral vascular 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="200"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cerebrovascular 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="200"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>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="200"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Connective tissue 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="200"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diabetes Mellitus</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="200"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Chronic kidney 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="200"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hemiplegia</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="200"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cancer</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="200"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>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="200"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HIV/AIDS</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="200"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>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="200"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Prioritized Healthcare Topics</title>
        <description>Twenty-four healthcare topics were selected once again from a literature and expert panel review, as well as corroborated by individuals living with COPD in five focus groups. Example healthcare topics include: relief of breathlessness; increase maximal amount of exercise individuals living with COPD can do inside and outside their homes; and prevent-lung flare-ups. Participants were asked to indicate their preference of the topics by assigning a percentage of their time, in increments of 10%, to the various healthcare topics, for a total of 100% of their time. For the 24 healthcare topics, individuals could select up to 10 topics (10% times 10 topics, for 100% of their time). The top five topics are presented as the most important topics for the participants and are indicative of areas of focus for future healthcare and research. The top five were presented in accordance to the request from the working group who developed the survey and reviewed the results.</description>
        <time_frame>Baseline</time_frame>
        <population>Participants answered an online survey and their medical chart information was gathered to compare responses across disease severity. Of the 148 participants, 130 completed the online survey with spirometry &amp; exacerbation and mMRC for Group ABCD analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Participation Differences by Individuals' Disease Severity</title>
            <description>For airflow obstruction, individuals were divided into quartiles based on their FEV1%predicted. (mild, moderate, severe, and very severe)</description>
          </group>
          <group group_id="O2">
            <title>Participation Differences by (GOLD) ABCD Classification</title>
            <description>Individuals' ABCD classifications were based on the 2017 GOLD guidelines based on modified British Medical Research Council (mMRC) dyspnea scores and 12-month exacerbation history.</description>
          </group>
          <group group_id="O3">
            <title>Quartile 1 - Mild Airflow Obstruction</title>
            <description>FEV1%predicted range = 65.1-184.8</description>
          </group>
          <group group_id="O4">
            <title>Quartile 2 - Moderate Airflow Obstruction</title>
            <description>FEV1% predicted range = 48.4-64.3</description>
          </group>
          <group group_id="O5">
            <title>Quartile 3 - Severe Airflow Obstruction</title>
            <description>FEV1% predicted range = 31.7-46.8</description>
          </group>
          <group group_id="O6">
            <title>Quartile 4 - Very Severe Airflow Obstruction</title>
            <description>FEV1% predicted range = 14.7-31.5</description>
          </group>
          <group group_id="O7">
            <title>Group A - Breathlessness Burden and Exacerbation Risk</title>
            <description>FEV1%predicted range = 42.3-69.4</description>
          </group>
          <group group_id="O8">
            <title>Group B - Breathlessness Burden and Exacerbation Risk</title>
            <description>FEV1% predicted range = 28.0-65.9</description>
          </group>
          <group group_id="O9">
            <title>Group C - Breathlessness Burden and Exacerbation Risk</title>
            <description>FEV1% predicted range = 27.0-67.0</description>
          </group>
          <group group_id="O10">
            <title>Group D - Breathlessness Burden and Exacerbation Risk</title>
            <description>FEV1% predicted range = 27.0-67.7</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Prioritized Healthcare Topics</title>
          <description>Twenty-four healthcare topics were selected once again from a literature and expert panel review, as well as corroborated by individuals living with COPD in five focus groups. Example healthcare topics include: relief of breathlessness; increase maximal amount of exercise individuals living with COPD can do inside and outside their homes; and prevent-lung flare-ups. Participants were asked to indicate their preference of the topics by assigning a percentage of their time, in increments of 10%, to the various healthcare topics, for a total of 100% of their time. For the 24 healthcare topics, individuals could select up to 10 topics (10% times 10 topics, for 100% of their time). The top five topics are presented as the most important topics for the participants and are indicative of areas of focus for future healthcare and research. The top five were presented in accordance to the request from the working group who developed the survey and reviewed the results.</description>
          <population>Participants answered an online survey and their medical chart information was gathered to compare responses across disease severity. Of the 148 participants, 130 completed the online survey with spirometry &amp; exacerbation and mMRC for Group ABCD analysis.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="148"/>
                <count group_id="O2" value="130"/>
                <count group_id="O3" value="37"/>
                <count group_id="O4" value="37"/>
                <count group_id="O5" value="37"/>
                <count group_id="O6" value="37"/>
                <count group_id="O7" value="26"/>
                <count group_id="O8" value="50"/>
                <count group_id="O9" value="14"/>
                <count group_id="O10" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Relief of Breathlessness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90"/>
                    <measurement group_id="O2" value="79"/>
                    <measurement group_id="O3" value="23"/>
                    <measurement group_id="O4" value="22"/>
                    <measurement group_id="O5" value="21"/>
                    <measurement group_id="O6" value="24"/>
                    <measurement group_id="O7" value="11"/>
                    <measurement group_id="O8" value="36"/>
                    <measurement group_id="O9" value="5"/>
                    <measurement group_id="O10" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Improve Your Ability to Improve Activities</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79"/>
                    <measurement group_id="O2" value="67"/>
                    <measurement group_id="O3" value="20"/>
                    <measurement group_id="O4" value="22"/>
                    <measurement group_id="O5" value="15"/>
                    <measurement group_id="O6" value="22"/>
                    <measurement group_id="O7" value="12"/>
                    <measurement group_id="O8" value="30"/>
                    <measurement group_id="O9" value="6"/>
                    <measurement group_id="O10" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prevent Lung Flare-Ups</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74"/>
                    <measurement group_id="O2" value="64"/>
                    <measurement group_id="O3" value="18"/>
                    <measurement group_id="O4" value="18"/>
                    <measurement group_id="O5" value="18"/>
                    <measurement group_id="O6" value="20"/>
                    <measurement group_id="O7" value="14"/>
                    <measurement group_id="O8" value="23"/>
                    <measurement group_id="O9" value="7"/>
                    <measurement group_id="O10" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discuss COPD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71"/>
                    <measurement group_id="O2" value="61"/>
                    <measurement group_id="O3" value="18"/>
                    <measurement group_id="O4" value="19"/>
                    <measurement group_id="O5" value="23"/>
                    <measurement group_id="O6" value="11"/>
                    <measurement group_id="O7" value="12"/>
                    <measurement group_id="O8" value="27"/>
                    <measurement group_id="O9" value="6"/>
                    <measurement group_id="O10" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Improve Physical Well-Being</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70"/>
                    <measurement group_id="O2" value="62"/>
                    <measurement group_id="O3" value="20"/>
                    <measurement group_id="O4" value="15"/>
                    <measurement group_id="O5" value="17"/>
                    <measurement group_id="O6" value="18"/>
                    <measurement group_id="O7" value="12"/>
                    <measurement group_id="O8" value="26"/>
                    <measurement group_id="O9" value="9"/>
                    <measurement group_id="O10" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Relief of breathlessness</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.91</p_value>
            <method>Chi-squared</method>
            <method_desc>Chi-squared value= .57</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Improve your ability to perform activities in and out of your home</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.31</p_value>
            <method>Chi-squared</method>
            <method_desc>Chi-squared value= 3.56</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Prevent lung flare-ups</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.96</p_value>
            <method>Chi-squared</method>
            <method_desc>Chi-squared value=.32</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Discuss COPD and its progression</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.04</p_value>
            <method>Chi-squared</method>
            <method_desc>Chi-squared value= 8.09</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Improve your physical well-being</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.70</p_value>
            <method>Chi-squared</method>
            <method_desc>Chi-squared value: 1.41</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Relief of breathlessness</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.01</p_value>
            <method>Chi-squared</method>
            <method_desc>Chi-squared value= 10.81</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Improve your ability to perform activities in and out of your home</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.49</p_value>
            <method>Chi-squared</method>
            <method_desc>Chi-squared value= 2.41</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Prevent lung flare-ups</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.93</p_value>
            <method>Chi-squared</method>
            <method_desc>Chi-squared value= .44</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Discuss COPD and its progression</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.60</p_value>
            <method>Chi-squared</method>
            <method_desc>Chi-squared value= 1.87</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Improve your physical well-being</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.31</p_value>
            <method>Chi-squared</method>
            <method_desc>Chi-squared value= 3.61</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Prioritized Research Topics</title>
        <description>Individuals were asked to indicate their research priorities from a list of research topics using a modified willingness-to-pay method (Kawata et al., 2014). The willingness-to-pay method allows individuals to assign preference to various topics by assigning a percentage of funds to the topic. A list of 22 research topics (e.g., to relieve breathlessness in individuals living with COPD, to increase access to lung transplantations) was created for this study through a literature review, expert consultation, and five focus groups with individuals living with COPD (n=23, 27% women). Individuals were asked to assign a percentage of funds, in increments of 10% of funding, to the 22 COPD research topics. Participants could assign anywhere between 10% of funding to 100% of funding to the topics. The top five were presented in accordance to the request from the working group who developed the survey and reviewed the results.</description>
        <time_frame>Baseline</time_frame>
        <population>Participants answered an online survey and their medical chart information was gathered to compare responses across disease severity. Of the 148 participants, 130 completed the online survey with spirometry &amp; exacerbation and mMRC for Group ABCD analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Participation Differences by Individuals' Disease Severity</title>
            <description>For airflow obstruction, individuals were divided into quartiles based on their FEV1%predicted. (mild, moderate, severe, and very severe)</description>
          </group>
          <group group_id="O2">
            <title>Participation Differences by (GOLD) ABCD Classification</title>
            <description>Individuals' ABCD classifications were based on the 2017 GOLD guidelines based on modified British Medical Research Council (mMRC) dyspnea scores and 12-month exacerbation history.</description>
          </group>
          <group group_id="O3">
            <title>Quartile 1 - Mild Airflow Obstruction</title>
            <description>FEV1%predicted range = 65.1-184.8</description>
          </group>
          <group group_id="O4">
            <title>Quartile 2 - Moderate Airflow Obstruction</title>
            <description>FEV1% predicted range = 48.4-64.3</description>
          </group>
          <group group_id="O5">
            <title>Quartile 3 - Severe Airflow Obstruction</title>
            <description>FEV1% predicted range = 31.7-46.8</description>
          </group>
          <group group_id="O6">
            <title>Quartile 4 - Very Severe Airflow Obstruction</title>
            <description>FEV1% predicted range = 14.7-31.5</description>
          </group>
          <group group_id="O7">
            <title>Group A - Breathlessness Burden and Exacerbation Risk</title>
            <description>FEV1%predicted range = 42.3-69.4</description>
          </group>
          <group group_id="O8">
            <title>Group B - Breathlessness Burden and Exacerbation Risk</title>
            <description>FEV1% predicted range = 28.0-65.9</description>
          </group>
          <group group_id="O9">
            <title>Group C - Breathlessness Burden and Exacerbation Risk</title>
            <description>FEV1% predicted range = 27.0-67.0</description>
          </group>
          <group group_id="O10">
            <title>Group D - Breathlessness Burden and Exacerbation Risk</title>
            <description>FEV1% predicted range = 27.0-67.7</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Prioritized Research Topics</title>
          <description>Individuals were asked to indicate their research priorities from a list of research topics using a modified willingness-to-pay method (Kawata et al., 2014). The willingness-to-pay method allows individuals to assign preference to various topics by assigning a percentage of funds to the topic. A list of 22 research topics (e.g., to relieve breathlessness in individuals living with COPD, to increase access to lung transplantations) was created for this study through a literature review, expert consultation, and five focus groups with individuals living with COPD (n=23, 27% women). Individuals were asked to assign a percentage of funds, in increments of 10% of funding, to the 22 COPD research topics. Participants could assign anywhere between 10% of funding to 100% of funding to the topics. The top five were presented in accordance to the request from the working group who developed the survey and reviewed the results.</description>
          <population>Participants answered an online survey and their medical chart information was gathered to compare responses across disease severity. Of the 148 participants, 130 completed the online survey with spirometry &amp; exacerbation and mMRC for Group ABCD analysis.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="148"/>
                <count group_id="O2" value="130"/>
                <count group_id="O3" value="37"/>
                <count group_id="O4" value="37"/>
                <count group_id="O5" value="37"/>
                <count group_id="O6" value="37"/>
                <count group_id="O7" value="26"/>
                <count group_id="O8" value="50"/>
                <count group_id="O9" value="14"/>
                <count group_id="O10" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>To relieve breathlessness in COPD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="113"/>
                    <measurement group_id="O2" value="98"/>
                    <measurement group_id="O3" value="28"/>
                    <measurement group_id="O4" value="29"/>
                    <measurement group_id="O5" value="26"/>
                    <measurement group_id="O6" value="30"/>
                    <measurement group_id="O7" value="20"/>
                    <measurement group_id="O8" value="40"/>
                    <measurement group_id="O9" value="7"/>
                    <measurement group_id="O10" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>To prevent the development of COPD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85"/>
                    <measurement group_id="O2" value="74"/>
                    <measurement group_id="O3" value="18"/>
                    <measurement group_id="O4" value="26"/>
                    <measurement group_id="O5" value="22"/>
                    <measurement group_id="O6" value="19"/>
                    <measurement group_id="O7" value="15"/>
                    <measurement group_id="O8" value="30"/>
                    <measurement group_id="O9" value="9"/>
                    <measurement group_id="O10" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>To prevent lung flare ups</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74"/>
                    <measurement group_id="O2" value="62"/>
                    <measurement group_id="O3" value="18"/>
                    <measurement group_id="O4" value="18"/>
                    <measurement group_id="O5" value="14"/>
                    <measurement group_id="O6" value="24"/>
                    <measurement group_id="O7" value="14"/>
                    <measurement group_id="O8" value="24"/>
                    <measurement group_id="O9" value="3"/>
                    <measurement group_id="O10" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>To increase the ability to exercise</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70"/>
                    <measurement group_id="O2" value="61"/>
                    <measurement group_id="O3" value="20"/>
                    <measurement group_id="O4" value="14"/>
                    <measurement group_id="O5" value="17"/>
                    <measurement group_id="O6" value="19"/>
                    <measurement group_id="O7" value="11"/>
                    <measurement group_id="O8" value="29"/>
                    <measurement group_id="O9" value="7"/>
                    <measurement group_id="O10" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>To improve maximal amount of exercise</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68"/>
                    <measurement group_id="O2" value="57"/>
                    <measurement group_id="O3" value="21"/>
                    <measurement group_id="O4" value="12"/>
                    <measurement group_id="O5" value="15"/>
                    <measurement group_id="O6" value="20"/>
                    <measurement group_id="O7" value="6"/>
                    <measurement group_id="O8" value="29"/>
                    <measurement group_id="O9" value="4"/>
                    <measurement group_id="O10" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>To relieve breathlessness in adults living with COPD</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.73</p_value>
            <method>Chi-squared</method>
            <method_desc>Chi-squared value: 1.31</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>To prevent the development of COPD</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.23</p_value>
            <method>Chi-squared</method>
            <method_desc>Chi-squared value= 4.28</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>To prevent lung flare-ups in adults living with COPD</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.14</p_value>
            <method>Chi-squared</method>
            <method_desc>Chi-squared value= 5.51</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>To increase the ability of adults living with COPD to exercise</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.52</p_value>
            <method>Chi-squared</method>
            <method_desc>Chi-squared value= 2.28</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>To improve the maximal amount of exercise of adults living with COPD in and out of the home</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.11</p_value>
            <method>Chi-squared</method>
            <method_desc>Chi-squared value= 5.88</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>To relieve breathlessness in adults living with COPD</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.14</p_value>
            <method>Chi-squared</method>
            <method_desc>Chi-squared value= 5.57</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>To prevent the development of COPD</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.73</p_value>
            <method>Chi-squared</method>
            <method_desc>Chi-squared value= 1.29</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>To prevent lung flare-ups in adults living with COPD</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.20</p_value>
            <method>Chi-squared</method>
            <method_desc>Chi-squared value= 4.64</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>To increase the ability of adults living with COPD to exercise</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.17</p_value>
            <method>Chi-squared</method>
            <method_desc>Chi-squared value= 5.02</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>To improve the maximal amount of exercise of adults living with COPD in and out of the home</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.02</p_value>
            <method>Chi-squared</method>
            <method_desc>Chi-square value= 9.97</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Were Not Satisfied With Their Participation in Daily and Social Activities</title>
        <description>Participants will answer questions about their participation in 26 daily activities, as well as their desire to participate in each of the 26 daily activities. This is a measure of those who indicated they wanted to increase their participation. 10 of the 26 activities and their outcome measures are listed below.&#xD;
Activity 1: Walking from one place to another outside of your home on a flat surface.&#xD;
Activity 2: Moving from one place to another using motorized transportation.&#xD;
Activity 3: Climbing two or more flights of stairs.&#xD;
Activity 4: Walking up a hill.&#xD;
Activity 5: Participating in regular exercise.&#xD;
Activity 6: Walking from one place to another in your home.&#xD;
Activity 7: Carrying light objects on a flat surface.&#xD;
Activity 8: Carrying heavy objects on a flat surface.&#xD;
Activity 9: Carrying-out low intensity physical activities</description>
        <time_frame>Baseline</time_frame>
        <population>Participants answered an online survey and their medical chart information was gathered to compare responses across disease severity. Of the 148 participants, 130 completed the online survey with spirometry &amp; exacerbation and mMRC for Group ABCD analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Participation Differences by Individuals' Disease Severity</title>
            <description>For airflow obstruction, individuals were divided into quartiles based on their FEV1%predicted. (mild, moderate, severe, and very severe)</description>
          </group>
          <group group_id="O2">
            <title>Participation Differences by (GOLD) ABCD Classification</title>
            <description>Individuals' ABCD classifications were based on the 2017 GOLD guidelines based on modified British Medical Research Council (mMRC) dyspnea scores and 12-month exacerbation history.</description>
          </group>
          <group group_id="O3">
            <title>Quartile 1 - Mild Airflow Obstruction</title>
            <description>FEV1%predicted range = 65.1-184.8</description>
          </group>
          <group group_id="O4">
            <title>Quartile 2 - Moderate Airflow Obstruction</title>
            <description>FEV1% predicted range = 48.4-64.3</description>
          </group>
          <group group_id="O5">
            <title>Quartile 3 - Severe Airflow Obstruction</title>
            <description>FEV1% predicted range = 31.7-46.8</description>
          </group>
          <group group_id="O6">
            <title>Quartile 4 - Very Severe Airflow Obstruction</title>
            <description>FEV1% predicted range = 14.7-31.5</description>
          </group>
          <group group_id="O7">
            <title>Group A - Breathlessness Burden and Exacerbation Risk</title>
            <description>FEV1%predicted range = 42.3-69.4</description>
          </group>
          <group group_id="O8">
            <title>Group B - Breathlessness Burden and Exacerbation Risk</title>
            <description>FEV1% predicted range = 28.0-65.9</description>
          </group>
          <group group_id="O9">
            <title>Group C - Breathlessness Burden and Exacerbation Risk</title>
            <description>FEV1% predicted range = 27.0-67.0</description>
          </group>
          <group group_id="O10">
            <title>Group D - Breathlessness Burden and Exacerbation Risk</title>
            <description>FEV1% predicted range = 27.0-67.7</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Were Not Satisfied With Their Participation in Daily and Social Activities</title>
          <description>Participants will answer questions about their participation in 26 daily activities, as well as their desire to participate in each of the 26 daily activities. This is a measure of those who indicated they wanted to increase their participation. 10 of the 26 activities and their outcome measures are listed below.&#xD;
Activity 1: Walking from one place to another outside of your home on a flat surface.&#xD;
Activity 2: Moving from one place to another using motorized transportation.&#xD;
Activity 3: Climbing two or more flights of stairs.&#xD;
Activity 4: Walking up a hill.&#xD;
Activity 5: Participating in regular exercise.&#xD;
Activity 6: Walking from one place to another in your home.&#xD;
Activity 7: Carrying light objects on a flat surface.&#xD;
Activity 8: Carrying heavy objects on a flat surface.&#xD;
Activity 9: Carrying-out low intensity physical activities</description>
          <population>Participants answered an online survey and their medical chart information was gathered to compare responses across disease severity. Of the 148 participants, 130 completed the online survey with spirometry &amp; exacerbation and mMRC for Group ABCD analysis.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="148"/>
                <count group_id="O2" value="130"/>
                <count group_id="O3" value="37"/>
                <count group_id="O4" value="37"/>
                <count group_id="O5" value="37"/>
                <count group_id="O6" value="37"/>
                <count group_id="O7" value="26"/>
                <count group_id="O8" value="50"/>
                <count group_id="O9" value="14"/>
                <count group_id="O10" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Activity 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="108"/>
                    <measurement group_id="O2" value="83"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="27"/>
                    <measurement group_id="O5" value="30"/>
                    <measurement group_id="O6" value="43"/>
                    <measurement group_id="O7" value="8"/>
                    <measurement group_id="O8" value="38"/>
                    <measurement group_id="O9" value="7"/>
                    <measurement group_id="O10" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="25"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="6"/>
                    <measurement group_id="O7" value="15"/>
                    <measurement group_id="O8" value="2"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="114"/>
                    <measurement group_id="O2" value="101"/>
                    <measurement group_id="O3" value="24"/>
                    <measurement group_id="O4" value="27"/>
                    <measurement group_id="O5" value="22"/>
                    <measurement group_id="O6" value="41"/>
                    <measurement group_id="O7" value="12"/>
                    <measurement group_id="O8" value="30"/>
                    <measurement group_id="O9" value="21"/>
                    <measurement group_id="O10" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="142"/>
                    <measurement group_id="O2" value="107"/>
                    <measurement group_id="O3" value="24"/>
                    <measurement group_id="O4" value="41"/>
                    <measurement group_id="O5" value="39"/>
                    <measurement group_id="O6" value="38"/>
                    <measurement group_id="O7" value="19"/>
                    <measurement group_id="O8" value="44"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="117"/>
                    <measurement group_id="O2" value="87"/>
                    <measurement group_id="O3" value="22"/>
                    <measurement group_id="O4" value="22"/>
                    <measurement group_id="O5" value="32"/>
                    <measurement group_id="O6" value="41"/>
                    <measurement group_id="O7" value="8"/>
                    <measurement group_id="O8" value="44"/>
                    <measurement group_id="O9" value="7"/>
                    <measurement group_id="O10" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="8"/>
                    <measurement group_id="O7" value="4"/>
                    <measurement group_id="O8" value="6"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99"/>
                    <measurement group_id="O2" value="86"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="22"/>
                    <measurement group_id="O5" value="28"/>
                    <measurement group_id="O6" value="38"/>
                    <measurement group_id="O7" value="7"/>
                    <measurement group_id="O8" value="27"/>
                    <measurement group_id="O9" value="14"/>
                    <measurement group_id="O10" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 9</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="28"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="19"/>
                    <measurement group_id="O7" value="8"/>
                    <measurement group_id="O8" value="8"/>
                    <measurement group_id="O9" value="7"/>
                    <measurement group_id="O10" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity 10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90"/>
                    <measurement group_id="O2" value="71"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="17"/>
                    <measurement group_id="O5" value="30"/>
                    <measurement group_id="O6" value="38"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="24"/>
                    <measurement group_id="O9" value="14"/>
                    <measurement group_id="O10" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Activity 1: Walking from one place to another outside of your home on a flat surface</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.05</p_value>
            <method>Chi-squared</method>
            <method_desc>Chi squared value= 17.20</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Activity 2: Moving from one place to another using motorized transportation</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.87</p_value>
            <method>Chi-squared</method>
            <method_desc>Chi-squared value= 4.56</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Activity 3: Climbing two or more flights of stairs</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.65</p_value>
            <method>Chi-squared</method>
            <method_desc>Chi-squared value= 6.85</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Activity 4: Walking up a hill</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.35</p_value>
            <method>Chi-squared</method>
            <method_desc>Chi-squared value= 10.00</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Activity 5: Participating in regular exercise requiring physical effort, to maintain or improve health or fitness</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.03</p_value>
            <method>Chi-squared</method>
            <method_desc>Chi-squared value= 18.75</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Activity 1: Walking from one place to another outside of your home on a flat surface</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.00</p_value>
            <method>Chi-squared</method>
            <method_desc>Chi-squared value= 35.52</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Activity 2: Moving from one place to another using motorized transportation</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.33</p_value>
            <method>Chi-squared</method>
            <method_desc>Chi-squared value= 10.23</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Activity 3: Climbing two or more flights of stairs</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.00</p_value>
            <method>Chi-squared</method>
            <method_desc>Chi-squared value= 23.94</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Activity 4: Walking up a hill</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.01</p_value>
            <method>Chi-squared</method>
            <method_desc>Chi-squared value= 22.80</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Activity 5: Participating in regular exercise requiring physical effort, to maintain or improve health or fitness</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.02</p_value>
            <method>Chi-squared</method>
            <method_desc>Chi-squared value= 20.43</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Forced Expiratory Volume in 1-sec (FEV1)</title>
        <description>Individuals forced expiratory volume in 1-sec (FEV1) as assessed by spirometry</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Participation Differences by Individuals' Disease Severity</title>
            <description>For airflow obstruction, individuals were divided into quartiles based on their FEV1%predicted. (mild, moderate, severe, and very severe)</description>
          </group>
          <group group_id="O2">
            <title>Participation Differences by (GOLD) ABCD</title>
            <description>Individuals' ABCD classifications were based on the 2017 GOLD guidelines based on modified British Medical Research Council (mMRC) dyspnea scores and 12-month exacerbation history.</description>
          </group>
          <group group_id="O3">
            <title>Quartile 1 - Mild Airflow Obstruction</title>
            <description>FEV1%predicted range = 65.1-184.8</description>
          </group>
          <group group_id="O4">
            <title>Quartile 2 - Moderate Airflow Obstruction</title>
            <description>FEV1% predicted range = 48.4-64.3</description>
          </group>
          <group group_id="O5">
            <title>Quartile 3 - Severe Airflow Obstruction</title>
            <description>FEV1% predicted range = 31.7-46.8</description>
          </group>
          <group group_id="O6">
            <title>Quartile 4 - Very Severe Airflow Obstruction</title>
            <description>FEV1% predicted range = 14.7-31.5</description>
          </group>
          <group group_id="O7">
            <title>Group A - Breathlessness Burden and Exacerbation Risk</title>
            <description>FEV1%predicted range = 42.3-69.4</description>
          </group>
          <group group_id="O8">
            <title>Group B - Breathlessness Burden and Exacerbation Risk</title>
            <description>FEV1% predicted range = 28.0-65.9</description>
          </group>
          <group group_id="O9">
            <title>Group C - Breathlessness Burden and Exacerbation Risk</title>
            <description>FEV1% predicted range = 27.0-67.0</description>
          </group>
          <group group_id="O10">
            <title>Group D - Breathlessness Burden and Exacerbation Risk</title>
            <description>FEV1% predicted range = 27.0-67.7</description>
          </group>
        </group_list>
        <measure>
          <title>Forced Expiratory Volume in 1-sec (FEV1)</title>
          <description>Individuals forced expiratory volume in 1-sec (FEV1) as assessed by spirometry</description>
          <units>percent predicted</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="148"/>
                <count group_id="O2" value="130"/>
                <count group_id="O3" value="37"/>
                <count group_id="O4" value="37"/>
                <count group_id="O5" value="37"/>
                <count group_id="O6" value="37"/>
                <count group_id="O7" value="26"/>
                <count group_id="O8" value="50"/>
                <count group_id="O9" value="14"/>
                <count group_id="O10" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.6" spread="23.2"/>
                    <measurement group_id="O2" value="48.5" spread="20.7"/>
                    <measurement group_id="O3" value="79.0" spread="21.5"/>
                    <measurement group_id="O4" value="55.6" spread="5.5"/>
                    <measurement group_id="O5" value="38.5" spread="4.8"/>
                    <measurement group_id="O6" value="25.2" spread="4.5"/>
                    <measurement group_id="O7" value="66.0" spread="20.2"/>
                    <measurement group_id="O8" value="47.1" spread="17.9"/>
                    <measurement group_id="O9" value="50.8" spread="20.3"/>
                    <measurement group_id="O10" value="37.8" spread="17.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.00</p_value>
            <method>Kruskal-Wallis</method>
            <method_desc>Non-parametric led to equal variance (levene's test) which couldn't be assumed, independent samples were taken (Kruskal-Wallis)</method_desc>
            <other_analysis_desc>F(3,144)=137.82</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>FEV1/FVC</title>
        <description>Individuals FEV1-to-forced vital capacity (FVC) ratio</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Participation Differences by Individuals' Disease Severity</title>
            <description>For airflow obstruction, individuals were divided into quartiles based on their FEV1%predicted. (mild, moderate, severe, and very severe)</description>
          </group>
          <group group_id="O2">
            <title>Participation Differences by (GOLD) ABCD</title>
            <description>Individuals' ABCD classifications were based on the 2017 GOLD guidelines based on modified British Medical Research Council (mMRC) dyspnea scores and 12-month exacerbation history.</description>
          </group>
          <group group_id="O3">
            <title>Quartile 1 - Mild Airflow Obstruction</title>
            <description>FEV1%predicted range = 65.1-184.8</description>
          </group>
          <group group_id="O4">
            <title>Quartile 2 - Moderate Airflow Obstruction</title>
            <description>FEV1% predicted range = 48.4-64.3</description>
          </group>
          <group group_id="O5">
            <title>Quartile 3 - Severe Airflow Obstruction</title>
            <description>FEV1% predicted range = 31.7-46.8</description>
          </group>
          <group group_id="O6">
            <title>Quartile 4 - Very Severe Airflow Obstruction</title>
            <description>FEV1% predicted range = 14.7-31.5</description>
          </group>
          <group group_id="O7">
            <title>Group A - Breathlessness Burden and Exacerbation Risk</title>
            <description>FEV1%predicted range = 42.3-69.4</description>
          </group>
          <group group_id="O8">
            <title>Group B - Breathlessness Burden and Exacerbation Risk</title>
            <description>FEV1% predicted range = 28.0-65.9</description>
          </group>
          <group group_id="O9">
            <title>Group C - Breathlessness Burden and Exacerbation Risk</title>
            <description>FEV1% predicted range = 27.0-67.0</description>
          </group>
          <group group_id="O10">
            <title>Group D - Breathlessness Burden and Exacerbation Risk</title>
            <description>FEV1% predicted range = 27.0-67.7</description>
          </group>
        </group_list>
        <measure>
          <title>FEV1/FVC</title>
          <description>Individuals FEV1-to-forced vital capacity (FVC) ratio</description>
          <units>Measured ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="148"/>
                <count group_id="O2" value="130"/>
                <count group_id="O3" value="37"/>
                <count group_id="O4" value="37"/>
                <count group_id="O5" value="37"/>
                <count group_id="O6" value="37"/>
                <count group_id="O7" value="26"/>
                <count group_id="O8" value="50"/>
                <count group_id="O9" value="14"/>
                <count group_id="O10" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.1" spread="11.8"/>
                    <measurement group_id="O2" value="49.0" spread="11.9"/>
                    <measurement group_id="O3" value="60.5" spread="8.5"/>
                    <measurement group_id="O4" value="53.8" spread="8.5"/>
                    <measurement group_id="O5" value="44.1" spread="8.9"/>
                    <measurement group_id="O6" value="38.1" spread="7.9"/>
                    <measurement group_id="O7" value="58.1" spread="7.3"/>
                    <measurement group_id="O8" value="47.9" spread="11.2"/>
                    <measurement group_id="O9" value="49.1" spread="12.8"/>
                    <measurement group_id="O10" value="44.5" spread="12.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.000</p_value>
            <method>ANOVA</method>
            <method_desc>Factorial ANOVA used because variance could be assumed</method_desc>
            <other_analysis_desc>F(3,144)=55.89 Partial ETA squared (effect size)=0.54</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Modified Medical Research Council Questionnaire on Breathlessness</title>
        <description>Self-reported intensity of activity related breathlessness as assessed by the modified Medical Research Council (mMRC) dyspnea scale (0-4). This questionnaire was used to measure participants' breathlessness burden using a single item scale from 0 to 4, where a score of 0-1 indicated mild breathlessness and 2-4 indicated increased breathlessness.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Participation Differences by Individuals' Disease Severity</title>
            <description>For airflow obstruction, individuals were divided into quartiles based on their FEV1%predicted. (mild, moderate, severe, and very severe)</description>
          </group>
          <group group_id="O2">
            <title>Participation Differences by (GOLD) ABCD</title>
            <description>Individuals' ABCD classifications were based on the 2017 GOLD guidelines based on modified British Medical Research Council (mMRC) dyspnea scores and 12-month exacerbation history.</description>
          </group>
          <group group_id="O3">
            <title>Quartile 1 - Mild Airflow Obstruction</title>
            <description>FEV1%predicted range = 65.1-184.8</description>
          </group>
          <group group_id="O4">
            <title>Quartile 2 - Moderate Airflow Obstruction</title>
            <description>FEV1% predicted range = 48.4-64.3</description>
          </group>
          <group group_id="O5">
            <title>Quartile 3 - Severe Airflow Obstruction</title>
            <description>FEV1% predicted range = 31.7-46.8</description>
          </group>
          <group group_id="O6">
            <title>Quartile 4 - Very Severe Airflow Obstruction</title>
            <description>FEV1% predicted range = 14.7-31.5</description>
          </group>
          <group group_id="O7">
            <title>Group A - Breathlessness Burden and Exacerbation Risk</title>
            <description>FEV1%predicted range = 42.3-69.4</description>
          </group>
          <group group_id="O8">
            <title>Group B - Breathlessness Burden and Exacerbation Risk</title>
            <description>FEV1% predicted range = 28.0-65.9</description>
          </group>
          <group group_id="O9">
            <title>Group C - Breathlessness Burden and Exacerbation Risk</title>
            <description>FEV1% predicted range = 27.0-67.0</description>
          </group>
          <group group_id="O10">
            <title>Group D - Breathlessness Burden and Exacerbation Risk</title>
            <description>FEV1% predicted range = 27.0-67.7</description>
          </group>
        </group_list>
        <measure>
          <title>Modified Medical Research Council Questionnaire on Breathlessness</title>
          <description>Self-reported intensity of activity related breathlessness as assessed by the modified Medical Research Council (mMRC) dyspnea scale (0-4). This questionnaire was used to measure participants' breathlessness burden using a single item scale from 0 to 4, where a score of 0-1 indicated mild breathlessness and 2-4 indicated increased breathlessness.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="148"/>
                <count group_id="O2" value="130"/>
                <count group_id="O3" value="37"/>
                <count group_id="O4" value="37"/>
                <count group_id="O5" value="37"/>
                <count group_id="O6" value="37"/>
                <count group_id="O7" value="26"/>
                <count group_id="O8" value="50"/>
                <count group_id="O9" value="14"/>
                <count group_id="O10" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>mMRC 0-1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                    <measurement group_id="O2" value="40"/>
                    <measurement group_id="O3" value="20"/>
                    <measurement group_id="O4" value="15"/>
                    <measurement group_id="O5" value="7"/>
                    <measurement group_id="O6" value="3"/>
                    <measurement group_id="O7" value="26"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="14"/>
                    <measurement group_id="O10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>mMRC ≥2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="101"/>
                    <measurement group_id="O2" value="90"/>
                    <measurement group_id="O3" value="15"/>
                    <measurement group_id="O4" value="22"/>
                    <measurement group_id="O5" value="30"/>
                    <measurement group_id="O6" value="34"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="50"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Data missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.00</p_value>
            <method>ANOVA</method>
            <method_desc>One-way ANOVA</method_desc>
            <other_analysis_desc>F(3,142)=7.61</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>COPD Assessment Test</title>
        <description>This questionnaire measure the impact COPD is having on well being and daily life. The CAT is an eight-item semantic differential scale from 0 to 5, where 0 is no impact and 5 is extremely impactful. Items include: I never cough| I cough all the time, I have no phlegm (mucus) in my chest at all | My chest is completely full of phlegm (mucus), My chest does not feel tight at all | My chest feels very tight, When I walk up a hill or one flight of stairs, I am not breathless | When I walk up a hill or one flight of stairs, I am very breathless, I am not limited doing any activities at home| I am very limited doing activities at home, I am confident leaving my home despite my lung condition| I am not at all confident leaving my home because of my lung condition, I sleep soundly | I don't sleep soundly because of my lung condition, I have lots of energy I have no energy at all. Participants' scores were totaled and a score of ≥ 10 indicated higher than normal burden of disease.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Participation Differences by Individuals' Disease Severity</title>
            <description>For airflow obstruction, individuals were divided into quartiles based on their FEV1%predicted. (mild, moderate, severe, and very severe)</description>
          </group>
          <group group_id="O2">
            <title>Participation Differences by (GOLD) ABCD</title>
            <description>Individuals' ABCD classifications were based on the 2017 GOLD guidelines based on modified British Medical Research Council (mMRC) dyspnea scores and 12-month exacerbation history.</description>
          </group>
          <group group_id="O3">
            <title>Quartile 1 - Mild Airflow Obstruction</title>
            <description>FEV1%predicted range = 65.1-184.8</description>
          </group>
          <group group_id="O4">
            <title>Quartile 2 - Moderate Airflow Obstruction</title>
            <description>FEV1% predicted range = 48.4-64.3</description>
          </group>
          <group group_id="O5">
            <title>Quartile 3 - Severe Airflow Obstruction</title>
            <description>FEV1% predicted range = 31.7-46.8</description>
          </group>
          <group group_id="O6">
            <title>Quartile 4 - Very Severe Airflow Obstruction</title>
            <description>FEV1% predicted range = 14.7-31.5</description>
          </group>
          <group group_id="O7">
            <title>Group A - Breathlessness Burden and Exacerbation Risk</title>
            <description>FEV1%predicted range = 42.3-69.4</description>
          </group>
          <group group_id="O8">
            <title>Group B - Breathlessness Burden and Exacerbation Risk</title>
            <description>FEV1% predicted range = 28.0-65.9</description>
          </group>
          <group group_id="O9">
            <title>Group C - Breathlessness Burden and Exacerbation Risk</title>
            <description>FEV1% predicted range = 27.0-67.0</description>
          </group>
          <group group_id="O10">
            <title>Group D - Breathlessness Burden and Exacerbation Risk</title>
            <description>FEV1% predicted range = 27.0-67.7</description>
          </group>
        </group_list>
        <measure>
          <title>COPD Assessment Test</title>
          <description>This questionnaire measure the impact COPD is having on well being and daily life. The CAT is an eight-item semantic differential scale from 0 to 5, where 0 is no impact and 5 is extremely impactful. Items include: I never cough| I cough all the time, I have no phlegm (mucus) in my chest at all | My chest is completely full of phlegm (mucus), My chest does not feel tight at all | My chest feels very tight, When I walk up a hill or one flight of stairs, I am not breathless | When I walk up a hill or one flight of stairs, I am very breathless, I am not limited doing any activities at home| I am very limited doing activities at home, I am confident leaving my home despite my lung condition| I am not at all confident leaving my home because of my lung condition, I sleep soundly | I don't sleep soundly because of my lung condition, I have lots of energy I have no energy at all. Participants' scores were totaled and a score of ≥ 10 indicated higher than normal burden of disease.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="148"/>
                <count group_id="O2" value="130"/>
                <count group_id="O3" value="37"/>
                <count group_id="O4" value="37"/>
                <count group_id="O5" value="37"/>
                <count group_id="O6" value="37"/>
                <count group_id="O7" value="26"/>
                <count group_id="O8" value="50"/>
                <count group_id="O9" value="14"/>
                <count group_id="O10" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CAT &lt;10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="22"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="6"/>
                    <measurement group_id="O6" value="3"/>
                    <measurement group_id="O7" value="8"/>
                    <measurement group_id="O8" value="6"/>
                    <measurement group_id="O9" value="5"/>
                    <measurement group_id="O10" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CAT ≥10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="122"/>
                    <measurement group_id="O2" value="107"/>
                    <measurement group_id="O3" value="26"/>
                    <measurement group_id="O4" value="32"/>
                    <measurement group_id="O5" value="30"/>
                    <measurement group_id="O6" value="34"/>
                    <measurement group_id="O7" value="18"/>
                    <measurement group_id="O8" value="44"/>
                    <measurement group_id="O9" value="9"/>
                    <measurement group_id="O10" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Data missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.31</p_value>
            <method>ANOVA</method>
            <method_desc>One-way ANOVA</method_desc>
            <other_analysis_desc>F(3,142)=1.21</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Godin Leisure Time Physical Activity Questionnaire</title>
        <description>Self-reported physical activity levels measured in length of bouts over the previous 7 days to determine physical activity frequency.</description>
        <time_frame>Baseline</time_frame>
        <population>Missing data n=8 for differences by individuals' disease severity and n=4 for differences by (GOLD) ABCD</population>
        <group_list>
          <group group_id="O1">
            <title>Participation Differences by Individuals' Disease Severity</title>
            <description>For airflow obstruction, individuals were divided into quartiles based on their FEV1%predicted. (mild, moderate, severe, and very severe)</description>
          </group>
          <group group_id="O2">
            <title>Participation Differences by (GOLD) ABCD</title>
            <description>Individuals' ABCD classifications were based on the 2017 GOLD guidelines based on modified British Medical Research Council (mMRC) dyspnea scores and 12-month exacerbation history.</description>
          </group>
          <group group_id="O3">
            <title>Quartile 1- Mild Airflow Obstruction</title>
            <description>FEV1% predicted range: 65.1-184.8</description>
          </group>
          <group group_id="O4">
            <title>Quartile 2 - Moderate Airflow Obstruction</title>
            <description>FEV1% predicted range: 48.4-64.3</description>
          </group>
          <group group_id="O5">
            <title>Quartile 3 - Severe Airflow Obstruction</title>
            <description>FEV1% predicted range: 31.7-46.8</description>
          </group>
          <group group_id="O6">
            <title>Quartile 4 - Very Severe Airflow Obstruction</title>
            <description>FEV1% predicted range: 14.7-31.5</description>
          </group>
          <group group_id="O7">
            <title>Group A - Breathlessness Burden and Exacerbation Risk</title>
            <description>FEV1% predicted range: 42.3-69.4</description>
          </group>
          <group group_id="O8">
            <title>Group B - Breathlessness Burden and Exacerbation Risk</title>
            <description>FEV1% predicted range:28.0-65.9</description>
          </group>
          <group group_id="O9">
            <title>Group C - Breathlessness Burden and Exacerbation Risk</title>
            <description>FEV1% predicted range:27.0-67.0</description>
          </group>
          <group group_id="O10">
            <title>Group D - Breathlessness Burden and Exacerbation Risk</title>
            <description>FEV1% predicted range:27.0-67.0</description>
          </group>
        </group_list>
        <measure>
          <title>Godin Leisure Time Physical Activity Questionnaire</title>
          <description>Self-reported physical activity levels measured in length of bouts over the previous 7 days to determine physical activity frequency.</description>
          <population>Missing data n=8 for differences by individuals' disease severity and n=4 for differences by (GOLD) ABCD</population>
          <units>Total minutes of Moderate to Vigorous PA</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="140"/>
                <count group_id="O2" value="126"/>
                <count group_id="O3" value="34"/>
                <count group_id="O4" value="35"/>
                <count group_id="O5" value="36"/>
                <count group_id="O6" value="35"/>
                <count group_id="O7" value="23"/>
                <count group_id="O8" value="50"/>
                <count group_id="O9" value="14"/>
                <count group_id="O10" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.64" spread="138.59"/>
                    <measurement group_id="O2" value="101.86" spread="194.49"/>
                    <measurement group_id="O3" value="100.29" spread="170.08"/>
                    <measurement group_id="O4" value="117.06" spread="175.61"/>
                    <measurement group_id="O5" value="42.78" spread="90.57"/>
                    <measurement group_id="O6" value="40.06" spread="79.70"/>
                    <measurement group_id="O7" value="166.52" spread="204.52"/>
                    <measurement group_id="O8" value="33.38" spread="76.05"/>
                    <measurement group_id="O9" value="138.57" spread="149.35"/>
                    <measurement group_id="O10" value="39.10" spread="73.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.04</p_value>
            <method>Kruskal-Wallis</method>
            <method_desc>Non-parametric independent sample Kruskal-Wallis test (failed variance assumed</method_desc>
            <other_analysis_desc>F(3,139)=8.09</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Satisfaction of Life Questionnaire</title>
        <description>This 5 item questionnaire was used to measure participants' level of life satisfaction. The higher the score, the higher the sense of life satisfaction. A score from 5-9 indicated extremely dissatisfied, 10-14 is dissatisfied, 15-19 indicated slightly below average life satisfaction. 20-24 is the average score, 25-29 is a high score indicative of higher life satisfaction and a score between 30-35 is a very high score and represent very high life satisfaction.</description>
        <time_frame>Baseline</time_frame>
        <population>Missing data n=6 for differences by individuals' disease severity and n=6 for differences by (GOLD) ABCD</population>
        <group_list>
          <group group_id="O1">
            <title>Participation Differences by Individuals' Disease Severity</title>
            <description>For airflow obstruction, individuals were divided into quartiles based on their FEV1%predicted. (mild, moderate, severe, and very severe)</description>
          </group>
          <group group_id="O2">
            <title>Participation Differences by (GOLD) ABCD</title>
            <description>Individuals' ABCD classifications were based on the 2017 GOLD guidelines based on modified British Medical Research Council (mMRC) dyspnea scores and 12-month exacerbation history.</description>
          </group>
          <group group_id="O3">
            <title>Quartile 1- Mild Airflow Obstruction</title>
            <description>FEV1% predicted range: 65.1-184.8</description>
          </group>
          <group group_id="O4">
            <title>Quartile 2 - Moderate Airflow Obstruction</title>
            <description>FEV1% predicted range: 48.4-64.3</description>
          </group>
          <group group_id="O5">
            <title>Quartile 3 - Severe Airflow Obstruction</title>
            <description>FEV1% predicted range: 31.7-46.8</description>
          </group>
          <group group_id="O6">
            <title>Quartile 4 - Very Severe Airflow Obstruction</title>
            <description>Quartile 4 - Very Severe Airflow Obstruction</description>
          </group>
          <group group_id="O7">
            <title>Group A - Breathlessness Burden and Exacerbation Risk</title>
            <description>FEV1% predicted range: 42.3-69.4</description>
          </group>
          <group group_id="O8">
            <title>Group B - Breathlessness Burden and Exacerbation Risk</title>
            <description>FEV1% predicted range:28.0-65.9</description>
          </group>
          <group group_id="O9">
            <title>Group C - Breathlessness Burden and Exacerbation Risk</title>
            <description>FEV1% predicted range:27.0-67.0</description>
          </group>
          <group group_id="O10">
            <title>Group D - Breathlessness Burden and Exacerbation Risk</title>
            <description>FEV1% predicted range:27.0-67.0</description>
          </group>
        </group_list>
        <measure>
          <title>Satisfaction of Life Questionnaire</title>
          <description>This 5 item questionnaire was used to measure participants' level of life satisfaction. The higher the score, the higher the sense of life satisfaction. A score from 5-9 indicated extremely dissatisfied, 10-14 is dissatisfied, 15-19 indicated slightly below average life satisfaction. 20-24 is the average score, 25-29 is a high score indicative of higher life satisfaction and a score between 30-35 is a very high score and represent very high life satisfaction.</description>
          <population>Missing data n=6 for differences by individuals' disease severity and n=6 for differences by (GOLD) ABCD</population>
          <units>total score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="142"/>
                <count group_id="O2" value="124"/>
                <count group_id="O3" value="35"/>
                <count group_id="O4" value="33"/>
                <count group_id="O5" value="37"/>
                <count group_id="O6" value="37"/>
                <count group_id="O7" value="26"/>
                <count group_id="O8" value="46"/>
                <count group_id="O9" value="12"/>
                <count group_id="O10" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.62" spread="8.16"/>
                    <measurement group_id="O2" value="18.38" spread="8.14"/>
                    <measurement group_id="O3" value="22.51" spread="7.78"/>
                    <measurement group_id="O4" value="20.94" spread="7.68"/>
                    <measurement group_id="O5" value="16.35" spread="7.23"/>
                    <measurement group_id="O6" value="15.1" spread="7.87"/>
                    <measurement group_id="O7" value="22.50" spread="6.83"/>
                    <measurement group_id="O8" value="17.33" spread="8.10"/>
                    <measurement group_id="O9" value="21.67" spread="6.73"/>
                    <measurement group_id="O10" value="15.95" spread="8.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.00</p_value>
            <method>ANOVA</method>
            <method_desc>One-way ANOVA</method_desc>
            <other_analysis_desc>F(3,143)=8.01</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Exacerbations Due to COPD in the Preceding 12 Months</title>
        <description>An exacerbation was defined as a change in medication due to a COPD exacerbation (i.e., the prescription of prednisone or a medical action plan) as indicated in the medical chart or hospital admission due to a COPD exacerbation.</description>
        <time_frame>baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Participation Differences by Individuals' Disease Severity</title>
            <description>For airflow obstruction, individuals were divided into quartiles based on their FEV1%predicted. (mild, moderate, severe, and very severe)</description>
          </group>
          <group group_id="O2">
            <title>Participation Differences by (GOLD) ABCD</title>
            <description>Individuals' ABCD classifications were based on the 2017 GOLD guidelines based on modified British Medical Research Council (mMRC) dyspnea scores and 12-month exacerbation history.</description>
          </group>
          <group group_id="O3">
            <title>Quartile 1- Mild Airflow Obstruction</title>
            <description>FEV1% predicted range: 65.1-184.8</description>
          </group>
          <group group_id="O4">
            <title>Quartile 2 - Moderate Airflow Obstruction</title>
            <description>FEV1% predicted range: 48.4-64.3</description>
          </group>
          <group group_id="O5">
            <title>Quartile 3 - Severe Airflow Obstruction</title>
            <description>FEV1% predicted range: 31.7-46.8</description>
          </group>
          <group group_id="O6">
            <title>Quartile 4 - Very Severe Airflow Obstruction</title>
            <description>Quartile 4 - Very Severe Airflow Obstruction</description>
          </group>
          <group group_id="O7">
            <title>Group A - Breathlessness Burden and Exacerbation Risk</title>
            <description>FEV1% predicted range: 42.3-69.4</description>
          </group>
          <group group_id="O8">
            <title>Group B - Breathlessness Burden and Exacerbation Risk</title>
            <description>FEV1% predicted range:28.0-65.9</description>
          </group>
          <group group_id="O9">
            <title>Group C - Breathlessness Burden and Exacerbation Risk</title>
            <description>FEV1% predicted range:27.0-67.0</description>
          </group>
          <group group_id="O10">
            <title>Group D - Breathlessness Burden and Exacerbation Risk</title>
            <description>FEV1% predicted range:27.0-67.0</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Exacerbations Due to COPD in the Preceding 12 Months</title>
          <description>An exacerbation was defined as a change in medication due to a COPD exacerbation (i.e., the prescription of prednisone or a medical action plan) as indicated in the medical chart or hospital admission due to a COPD exacerbation.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="148"/>
                <count group_id="O2" value="130"/>
                <count group_id="O3" value="37"/>
                <count group_id="O4" value="37"/>
                <count group_id="O5" value="37"/>
                <count group_id="O6" value="37"/>
                <count group_id="O7" value="26"/>
                <count group_id="O8" value="50"/>
                <count group_id="O9" value="14"/>
                <count group_id="O10" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of participants with 0-1 exacerbations</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92"/>
                    <measurement group_id="O2" value="76"/>
                    <measurement group_id="O3" value="30"/>
                    <measurement group_id="O4" value="27"/>
                    <measurement group_id="O5" value="19"/>
                    <measurement group_id="O6" value="16"/>
                    <measurement group_id="O7" value="26"/>
                    <measurement group_id="O8" value="50"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of participants with 2+ or 1 exacerbations leading to hospital admission</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56"/>
                    <measurement group_id="O2" value="54"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="10"/>
                    <measurement group_id="O5" value="18"/>
                    <measurement group_id="O6" value="21"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="14"/>
                    <measurement group_id="O10" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not assessed.</desc>
      <group_list>
        <group group_id="E1">
          <title>All Participants</title>
          <description>Participants answered an online survey and their medical chart information was gathered to compare responses across disease severity. This was a single arm study.</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"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" 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"/>
              </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>Emilie Michalovic, Ph.D. Candidate</name_or_title>
      <organization>McGill University</organization>
      <phone>514-941-6450</phone>
      <email>emilie.michalovic@mail.mcgill.ca</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/NCT02970422
org study id: 15-203-MUHC
nct id: NCT02970422
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to distribute a questionnaire created for individuals living
      with chronic obstructive pulmonary disease (COPD) to assess their activities, participation,
      and healthcare and COPD-related research priorities. The data collected will be compared
      across diagnosed COPD stages and disease severity to determine the extent to which adults
      with COPD participate in the listed activities and identify their primary research and
      healthcare related priorities. The questionnaire was originally developed based on past
      research then verified by a panel of COPD and participation experts; as well as, individuals
      living with COPD in the form of focus groups. The questionnaire will now be administered to
      200 individuals living COPD (50 in each GOLD stage) at three sites across Montreal where
      clinical data for each participant will be available. This phase will help establish the
      reliability of the questionnaire.
observational model: Other
time perspective: Cross-Sectional
measure: Number of Participants Who Prioritized Healthcare Topics
time frame: Baseline
description: Twenty-four healthcare topics were selected once again from a literature and expert panel review, as well as corroborated by individuals living with COPD in five focus groups. Example healthcare topics include: relief of breathlessness; increase maximal amount of exercise individuals living with COPD can do inside and outside their homes; and prevent-lung flare-ups. Participants were asked to indicate their preference of the topics by assigning a percentage of their time, in increments of 10%, to the various healthcare topics, for a total of 100% of their time. For the 24 healthcare topics, individuals could select up to 10 topics (10% times 10 topics, for 100% of their time). The top five topics are presented as the most important topics for the participants and are indicative of areas of focus for future healthcare and research. The top five were presented in accordance to the request from the working group who developed the survey and reviewed the results.
measure: Number of Participants Who Prioritized Research Topics
time frame: Baseline
description: Individuals were asked to indicate their research priorities from a list of research topics using a modified willingness-to-pay method (Kawata et al., 2014). The willingness-to-pay method allows individuals to assign preference to various topics by assigning a percentage of funds to the topic. A list of 22 research topics (e.g., to relieve breathlessness in individuals living with COPD, to increase access to lung transplantations) was created for this study through a literature review, expert consultation, and five focus groups with individuals living with COPD (n=23, 27% women). Individuals were asked to assign a percentage of funds, in increments of 10% of funding, to the 22 COPD research topics. Participants could assign anywhere between 10% of funding to 100% of funding to the topics. The top five were presented in accordance to the request from the working group who developed the survey and reviewed the results.
measure: Number of Participants Who Were Not Satisfied With Their Participation in Daily and Social Activities
time frame: Baseline
description: Participants will answer questions about their participation in 26 daily activities, as well as their desire to participate in each of the 26 daily activities. This is a measure of those who indicated they wanted to increase their participation. 10 of the 26 activities and their outcome measures are listed below.
Activity 1: Walking from one place to another outside of your home on a flat surface.
Activity 2: Moving from one place to another using motorized transportation.
Activity 3: Climbing two or more flights of stairs.
Activity 4: Walking up a hill.
Activity 5: Participating in regular exercise.
Activity 6: Walking from one place to another in your home.
Activity 7: Carrying light objects on a flat surface.
Activity 8: Carrying heavy objects on a flat surface.
Activity 9: Carrying-out low intensity physical activities
measure: Forced Expiratory Volume in 1-sec (FEV1)
time frame: Baseline
description: Individuals forced expiratory volume in 1-sec (FEV1) as assessed by spirometry
measure: FEV1/FVC
time frame: Baseline
description: Individuals FEV1-to-forced vital capacity (FVC) ratio
measure: Modified Medical Research Council Questionnaire on Breathlessness
time frame: Baseline
description: Self-reported intensity of activity related breathlessness as assessed by the modified Medical Research Council (mMRC) dyspnea scale (0-4). This questionnaire was used to measure participants' breathlessness burden using a single item scale from 0 to 4, where a score of 0-1 indicated mild breathlessness and 2-4 indicated increased breathlessness.
measure: COPD Assessment Test
time frame: Baseline
description: This questionnaire measure the impact COPD is having on well being and daily life. The CAT is an eight-item semantic differential scale from 0 to 5, where 0 is no impact and 5 is extremely impactful. Items include: I never cough| I cough all the time, I have no phlegm (mucus) in my chest at all | My chest is completely full of phlegm (mucus), My chest does not feel tight at all | My chest feels very tight, When I walk up a hill or one flight of stairs, I am not breathless | When I walk up a hill or one flight of stairs, I am very breathless, I am not limited doing any activities at home| I am very limited doing activities at home, I am confident leaving my home despite my lung condition| I am not at all confident leaving my home because of my lung condition, I sleep soundly | I don't sleep soundly because of my lung condition, I have lots of energy I have no energy at all. Participants' scores were totaled and a score of ≥ 10 indicated higher than normal burden of disease.
measure: Godin Leisure Time Physical Activity Questionnaire
time frame: Baseline
description: Self-reported physical activity levels measured in length of bouts over the previous 7 days to determine physical activity frequency.
measure: Satisfaction of Life Questionnaire
time frame: Baseline
description: This 5 item questionnaire was used to measure participants' level of life satisfaction. The higher the score, the higher the sense of life satisfaction. A score from 5-9 indicated extremely dissatisfied, 10-14 is dissatisfied, 15-19 indicated slightly below average life satisfaction. 20-24 is the average score, 25-29 is a high score indicative of higher life satisfaction and a score between 30-35 is a very high score and represent very high life satisfaction.
measure: Number of Participants With Exacerbations Due to COPD in the Preceding 12 Months
time frame: baseline
description: An exacerbation was defined as a change in medication due to a COPD exacerbation (i.e., the prescription of prednisone or a medical action plan) as indicated in the medical chart or hospital admission due to a COPD exacerbation.
arm group label: Quartile 1 [Mild]
arm group label: Quartile 2 [Moderate]
arm group label: Quartile 3 [Severe]
arm group label: Quartile 4 [Very Severe]
intervention type: Other
intervention name: Patient Survey
description: Participants will answer an online survey and their medical chart information will be gathered to compare responses across disease severity.
arm group label: Quartile 1 [Mild]
arm group label: Quartile 2 [Moderate]
arm group label: Quartile 3 [Severe]
arm group label: Quartile 4 [Very Severe]
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 90 Years
healthy volunteers: No
last name: Dennis Jensen, Ph.D.
role: Principal Investigator
affiliation: McGill University
last name: Shane N Sweet, Ph.D.
role: Principal Investigator
affiliation: McGill University
facility: 
country: Canada
url: http://www.mcgill.ca/cerpl/
description: Clinical Exercise and Respiratory Physiology Laboratory (CERPL)
url: http://exercisepsych.research.mcgill.ca/
description: Theories and Interventions in Exercise and Health Psychology (TIE) Laboratory
responsible party type: Principal Investigator
investigator affiliation: McGill University
investigator full name: Dennis Jensen, Ph.D.
investigator title: Assistant Professor
mesh term: Lung Diseases
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: No
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