<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/NCT03811340</url>
  </required_header>
  <id_info>
    <org_study_id>18-113</org_study_id>
    <nct_id>NCT03811340</nct_id>
  </id_info>
  <brief_title>Female Patient Preferences Regarding Physician Gender</brief_title>
  <official_title>Female Patient Preferences Regarding Physician Gender; is There a Difference? A National Survey</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 cross sectional survey study to describe female patient preferences when choosing&#xD;
      their OB/GYN and other providers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The American College of Obstetricians and Gynecologists (ACOG) published that as of 2009,&#xD;
      79.7% of the Obstetrics and Gynecology residents were female. Given the striking decline in&#xD;
      male providers selecting OB/GYN in more recent years, it is critical to characterize patient&#xD;
      preferences in the current environment.&#xD;
&#xD;
      Nevertheless, it is not clear that females have strong preferences regarding gender. We hope&#xD;
      to better understand the influence of bias on physician gender in present day.&#xD;
&#xD;
      The purpose of this study is to describe female population preference based on physician&#xD;
      gender and specialty.&#xD;
&#xD;
      The study will be conducted on an online platform distributed across the United States by the&#xD;
      aid of SurveyMonkey® .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 5, 2019</start_date>
  <completion_date type="Actual">May 6, 2019</completion_date>
  <primary_completion_date type="Actual">March 6, 2019</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>Proportion of Female Respondents Having Their Preferences Based on Physician Gender for the OB/GYN Care</measure>
    <time_frame>During a 10 minute period of completing the survey electronically</time_frame>
    <description>Proportion of female respondents whose responses are &quot;Male physician&quot; or &quot;Female physician&quot; over &quot;No preference&quot; for the question 15, &quot;For my obstetrician/gynecologist, overall I would prefer a...&quot;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of Female Respondents Having Their Preferences Based on Physician Gender for the Primary Care Physician</measure>
    <time_frame>During a 10 minute period of completing the survey electronically</time_frame>
    <description>Proportion of female respondents whose responses are &quot;Male physician&quot; or &quot;Female physician&quot; over &quot;No preference&quot; for the question 16, &quot;For my primary care physician, overall I would prefer a...&quot;</description>
  </primary_outcome>
  <enrollment type="Actual">1015</enrollment>
  <condition>Female Patient Preference</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Female population residing in the USA&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Exclusion Criteria:&#xD;
&#xD;
          -  Unwillingness to participate in the study&#xD;
&#xD;
          -  Lack of access to the internet&#xD;
&#xD;
          -  Non-English speaking&#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>October 2022</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <results_first_submitted>October 19, 2022</results_first_submitted>
  <results_first_submitted_qc>October 19, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">September 1, 2023</results_first_posted>
  <last_update_submitted>October 19, 2022</last_update_submitted>
  <last_update_submitted_qc>October 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2023</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/40/NCT03811340/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>1000 responses from females across the U.S were expected</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Survey Population</title>
          <description>All women between 18 and 80 years of age residing in the USA</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1105"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1015"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="90"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>subjects did not complete the survey.</title>
              <participants_list>
                <participants group_id="P1" count="90"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Survey Population</title>
          <description>All women between 18 and 80 years of age residing in the USA</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1015"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>18-30</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="339"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>31-45</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="189"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>46-60</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="373"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>61-75</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="107"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;75</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </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="1015"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Not Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="865"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="135"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prefer not to answer</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </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="1015"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Proportion of Female Respondents Having Their Preferences Based on Physician Gender for the OB/GYN Care</title>
        <description>Proportion of female respondents whose responses are &quot;Male physician&quot; or &quot;Female physician&quot; over &quot;No preference&quot; for the question 15, &quot;For my obstetrician/gynecologist, overall I would prefer a...&quot;</description>
        <time_frame>During a 10 minute period of completing the survey electronically</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Survey Population</title>
            <description>All women between 18 and 80 years of age residing in the USA</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Female Respondents Having Their Preferences Based on Physician Gender for the OB/GYN Care</title>
          <description>Proportion of female respondents whose responses are &quot;Male physician&quot; or &quot;Female physician&quot; over &quot;No preference&quot; for the question 15, &quot;For my obstetrician/gynecologist, overall I would prefer a...&quot;</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1015"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Female physician</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="667"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Male physician</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No preference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="261"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Proportion of Female Respondents Having Their Preferences Based on Physician Gender for the Primary Care Physician</title>
        <description>Proportion of female respondents whose responses are &quot;Male physician&quot; or &quot;Female physician&quot; over &quot;No preference&quot; for the question 16, &quot;For my primary care physician, overall I would prefer a...&quot;</description>
        <time_frame>During a 10 minute period of completing the survey electronically</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Survey Population</title>
            <description>All women between 18 and 80 years of age residing in the USA</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Female Respondents Having Their Preferences Based on Physician Gender for the Primary Care Physician</title>
          <description>Proportion of female respondents whose responses are &quot;Male physician&quot; or &quot;Female physician&quot; over &quot;No preference&quot; for the question 16, &quot;For my primary care physician, overall I would prefer a...&quot;</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1015"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Female physician preferred</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="473"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Male physician preferred</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No preference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="440"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>During a 10 minute period of completing the survey electronically</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Survey Population</title>
          <description>All women between 18 and 80 years of age residing in the USA</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="1015"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1015"/>
              </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="1015"/>
              </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>Rachel Pauls, MD</name_or_title>
      <organization>TriHealth Inc.</organization>
      <phone>513-463-4300</phone>
      <email>Rachel_Pauls@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/NCT03811340
org study id: 18-113
nct id: NCT03811340
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a cross sectional survey study to describe female patient preferences when choosing
      their OB/GYN and other providers.
The American College of Obstetricians and Gynecologists (ACOG) published that as of 2009,
      79.7% of the Obstetrics and Gynecology residents were female. Given the striking decline in
      male providers selecting OB/GYN in more recent years, it is critical to characterize patient
      preferences in the current environment.

      Nevertheless, it is not clear that females have strong preferences regarding gender. We hope
      to better understand the influence of bias on physician gender in present day.

      The purpose of this study is to describe female population preference based on physician
      gender and specialty.

      The study will be conducted on an online platform distributed across the United States by the
      aid of SurveyMonkey® .
observational model: Other
time perspective: Cross-Sectional
measure: Proportion of Female Respondents Having Their Preferences Based on Physician Gender for the OB/GYN Care
time frame: During a 10 minute period of completing the survey electronically
description: Proportion of female respondents whose responses are "Male physician" or "Female physician" over "No preference" for the question 15, "For my obstetrician/gynecologist, overall I would prefer a..."
measure: Proportion of Female Respondents Having Their Preferences Based on Physician Gender for the Primary Care Physician
time frame: During a 10 minute period of completing the survey electronically
description: Proportion of female respondents whose responses are "Male physician" or "Female physician" over "No preference" for the question 16, "For my primary care physician, overall I would prefer a..."
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: 