<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/NCT03785548</url>
  </required_header>
  <id_info>
    <org_study_id>18-107</org_study_id>
    <nct_id>NCT03785548</nct_id>
  </id_info>
  <brief_title>Utilization of the Mirror During Pelvic Exams</brief_title>
  <official_title>Utilization of the Mirror During Pelvic Exams: Does it Reduce Patient Vulnerability and Discomfort?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>TriHealth Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>TriHealth Inc.</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>
      This is a prospective cohort study to determine if using a birthing mirror during the&#xD;
      patient's pelvic examination decreases patients's degree of vulnerability and discomfort.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In Obstetrics and Gynecology and its gynecologic subspecialties, the pelvic examination is&#xD;
      routine practice for screening and diagnostic purposes. Nevertheless, due to their intimate&#xD;
      nature, pelvic examinations may result in loss of control, embarrassment, discomfort and&#xD;
      anxiety.&#xD;
&#xD;
      The mirror pelvic exam has been a proposed technique to decrease patient anxiety and improve&#xD;
      comfort during an already uncomfortable examination. However, little research has focused on&#xD;
      this modality to date.&#xD;
&#xD;
      The purpose of this study is to investigate whether the mirror pelvic exam decreases the&#xD;
      level of vulnerability and discomfort experienced during the pelvic examination.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 15, 2019</start_date>
  <completion_date type="Actual">July 1, 2020</completion_date>
  <primary_completion_date type="Actual">May 29, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Group Difference in Visual Analog Scale (VAS) on Level of Vulnerability</measure>
    <time_frame>30 minutes after the pelvic exam</time_frame>
    <description>VAS on vulnerability level will be measured after the pelvic exam, and group difference after controlling for baseline vulnerability, will be calculated. The VAS is a validated 100 millimeter scale with 'no vulnerability' represented as 0 mm and 'very vulnerable' equating to 100 mm.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Group Difference in Visual Analog Scale (VAS) on Level of Pain/Discomfort</measure>
    <time_frame>30 minutes after the pelvic exam</time_frame>
    <description>VAS on discomfort level will be measured after the pelvic exam, and group difference after controlling for baseline discomfort level, will be calculated. The VAS is a validated 100 millimeter scale with 'no pain' represented as 0 mm and 'most pain' equating to 100 mm.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">147</enrollment>
  <condition>Pelvic Exam</condition>
  <arm_group>
    <arm_group_label>Mirror group</arm_group_label>
    <description>This group of patients agree to have the mirror pelvic exam, and they will undergo routine pelvic examination by a physician with the usage of a mirror in the room.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No mirror group</arm_group_label>
    <description>This group of patients decline a mirror, and they will undergo the standard pelvic examination.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usage of a mirror</intervention_name>
    <description>using a mirror during the pelvic examination</description>
    <arm_group_label>Mirror group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All women 18 years of age to 80, who undergo pelvic exam by a physician at Cincinnati&#xD;
        Urogynecology Associates, TriHealth will be approached for recruitment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  New patients undergoing a pelvic exam performed by a physician at Cincinnati&#xD;
             Urogynecology Associates, TriHealth&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Existing patients&#xD;
&#xD;
          -  Unwillingness to participate in the study&#xD;
&#xD;
          -  Physical or mental impairment that would affect the subject's ability to visualize the&#xD;
             mirror during examination or to complete questionnaires&#xD;
&#xD;
          -  Inability to understand English&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rachel Pauls, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>TriHealth - Cincinnati Urogynecology Associates</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cincinnati Urogynecology Associates</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <results_first_submitted>July 21, 2020</results_first_submitted>
  <results_first_submitted_qc>August 5, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">August 17, 2020</results_first_posted>
  <last_update_submitted>August 5, 2020</last_update_submitted>
  <last_update_submitted_qc>August 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 15, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/48/NCT03785548/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Mirror Group</title>
          <description>This group of patients agree to have the mirror pelvic exam, and they will undergo routine pelvic examination by a physician with the usage of a mirror in the room.&#xD;
Usage of a mirror: using a mirror during the pelvic examination</description>
        </group>
        <group group_id="P2">
          <title>No Mirror Group</title>
          <description>This group of patients decline a mirror, and they will undergo the standard pelvic examination.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="73"/>
                <participants group_id="P2" count="74"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="71"/>
                <participants group_id="P2" count="74"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>age &gt; 80</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>no Postop queries</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Mirror Group</title>
          <description>This group of patients agree to have the mirror pelvic exam, and they will undergo routine pelvic examination by a physician with the usage of a mirror in the room.&#xD;
Usage of a mirror: using a mirror during the pelvic examination</description>
        </group>
        <group group_id="B2">
          <title>No Mirror Group</title>
          <description>This group of patients decline a mirror, and they will undergo the standard pelvic examination.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="71"/>
            <count group_id="B2" value="74"/>
            <count group_id="B3" value="145"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53.99" spread="12.96"/>
                    <measurement group_id="B2" value="57.84" spread="13.86"/>
                    <measurement group_id="B3" value="55.95" spread="13.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="71"/>
                    <measurement group_id="B2" value="74"/>
                    <measurement group_id="B3" value="145"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <description>Participants checked all that apply</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="66"/>
                    <measurement group_id="B3" value="128"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>American Indian/Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prefer not to answer</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="71"/>
                    <measurement group_id="B2" value="74"/>
                    <measurement group_id="B3" value="145"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Group Difference in Visual Analog Scale (VAS) on Level of Vulnerability</title>
        <description>VAS on vulnerability level will be measured after the pelvic exam, and group difference after controlling for baseline vulnerability, will be calculated. The VAS is a validated 100 millimeter scale with 'no vulnerability' represented as 0 mm and 'very vulnerable' equating to 100 mm.</description>
        <time_frame>30 minutes after the pelvic exam</time_frame>
        <population>There are 2 missing outcomes from Mirror group</population>
        <group_list>
          <group group_id="O1">
            <title>Mirror Group</title>
            <description>This group of patients agree to have the mirror pelvic exam, and they will undergo routine pelvic examination by a physician with the usage of a mirror in the room.&#xD;
Usage of a mirror: using a mirror during the pelvic examination</description>
          </group>
          <group group_id="O2">
            <title>No Mirror Group</title>
            <description>This group of patients decline a mirror, and they will undergo the standard pelvic examination.</description>
          </group>
        </group_list>
        <measure>
          <title>Group Difference in Visual Analog Scale (VAS) on Level of Vulnerability</title>
          <description>VAS on vulnerability level will be measured after the pelvic exam, and group difference after controlling for baseline vulnerability, will be calculated. The VAS is a validated 100 millimeter scale with 'no vulnerability' represented as 0 mm and 'very vulnerable' equating to 100 mm.</description>
          <population>There are 2 missing outcomes from Mirror group</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.294" spread="1.854"/>
                    <measurement group_id="O2" value="16.145" spread="1.789"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.270</p_value>
            <method>ANCOVA</method>
            <method_desc>F(1, 140)=1.225</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>2.851</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.576</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.241</ci_lower_limit>
            <ci_upper_limit>7.944</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Group Difference in Visual Analog Scale (VAS) on Level of Pain/Discomfort</title>
        <description>VAS on discomfort level will be measured after the pelvic exam, and group difference after controlling for baseline discomfort level, will be calculated. The VAS is a validated 100 millimeter scale with 'no pain' represented as 0 mm and 'most pain' equating to 100 mm.</description>
        <time_frame>30 minutes after the pelvic exam</time_frame>
        <population>Each group has 1 missing outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>Mirror Group</title>
            <description>This group of patients agree to have the mirror pelvic exam, and they will undergo routine pelvic examination by a physician with the usage of a mirror in the room.&#xD;
Usage of a mirror: using a mirror during the pelvic examination</description>
          </group>
          <group group_id="O2">
            <title>No Mirror Group</title>
            <description>This group of patients decline a mirror, and they will undergo the standard pelvic examination.</description>
          </group>
        </group_list>
        <measure>
          <title>Group Difference in Visual Analog Scale (VAS) on Level of Pain/Discomfort</title>
          <description>VAS on discomfort level will be measured after the pelvic exam, and group difference after controlling for baseline discomfort level, will be calculated. The VAS is a validated 100 millimeter scale with 'no pain' represented as 0 mm and 'most pain' equating to 100 mm.</description>
          <population>Each group has 1 missing outcome.</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.683" spread="2.201"/>
                    <measurement group_id="O2" value="19.824" spread="2.154"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.964</p_value>
            <method>ANCOVA</method>
            <method_desc>F(1, 140)=0.002</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.141</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.098</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.983</ci_lower_limit>
            <ci_upper_limit>6.266</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>within 30 minutes after pelvic examination</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Mirror Group</title>
          <description>This group of patients agree to have the mirror pelvic exam, and they will undergo routine pelvic examination by a physician with the usage of a mirror in the room.&#xD;
Usage of a mirror: using a mirror during the pelvic examination</description>
        </group>
        <group group_id="E2">
          <title>No Mirror Group</title>
          <description>This group of patients decline a mirror, and they will undergo the standard pelvic examination.</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="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
              </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="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Tiffanie Tam, Md</name_or_title>
      <organization>TriHealth Inc.</organization>
      <phone>513-463-4300</phone>
      <email>Tiffanie_Tam@trihealth.com</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/NCT03785548
org study id: 18-107
nct id: NCT03785548
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective cohort study to determine if using a birthing mirror during the
      patient's pelvic examination decreases patients's degree of vulnerability and discomfort.
In Obstetrics and Gynecology and its gynecologic subspecialties, the pelvic examination is
      routine practice for screening and diagnostic purposes. Nevertheless, due to their intimate
      nature, pelvic examinations may result in loss of control, embarrassment, discomfort and
      anxiety.

      The mirror pelvic exam has been a proposed technique to decrease patient anxiety and improve
      comfort during an already uncomfortable examination. However, little research has focused on
      this modality to date.

      The purpose of this study is to investigate whether the mirror pelvic exam decreases the
      level of vulnerability and discomfort experienced during the pelvic examination.
observational model: Cohort
time perspective: Prospective
measure: Group Difference in Visual Analog Scale (VAS) on Level of Vulnerability
time frame: 30 minutes after the pelvic exam
description: VAS on vulnerability level will be measured after the pelvic exam, and group difference after controlling for baseline vulnerability, will be calculated. The VAS is a validated 100 millimeter scale with 'no vulnerability' represented as 0 mm and 'very vulnerable' equating to 100 mm.
measure: Group Difference in Visual Analog Scale (VAS) on Level of Pain/Discomfort
time frame: 30 minutes after the pelvic exam
description: VAS on discomfort level will be measured after the pelvic exam, and group difference after controlling for baseline discomfort level, will be calculated. The VAS is a validated 100 millimeter scale with 'no pain' represented as 0 mm and 'most pain' equating to 100 mm.
arm group label: Mirror group
description: This group of patients agree to have the mirror pelvic exam, and they will undergo routine pelvic examination by a physician with the usage of a mirror in the room.
arm group label: No mirror group
description: This group of patients decline a mirror, and they will undergo the standard pelvic examination.
intervention type: Other
intervention name: Usage of a mirror
description: using a mirror during the pelvic examination
arm group label: Mirror group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rachel Pauls, MD
role: Principal Investigator
affiliation: TriHealth - Cincinnati Urogynecology Associates
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 