<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/NCT01725581</url>
  </required_header>
  <id_info>
    <org_study_id>PEAT</org_study_id>
    <nct_id>NCT01725581</nct_id>
  </id_info>
  <brief_title>A Study to Test a New Pelvic Examination Assessment Tool</brief_title>
  <acronym>PEAT</acronym>
  <official_title>A Study to Test the Validity and Reliability of an Objective Structured Assessment of Technical Skills in Pelvic Examination</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Birmingham Women's NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Birmingham Women's NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to show that a new assessment tool for pelvic examination is&#xD;
      valid and reliable.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Physical examination of the pelvis is an important core skill that medical students need to&#xD;
      acquire. However, due to its intimate nature some students are graduating unable to perform&#xD;
      competent pelvic examinations. At present, evaluation of the medical students competence at&#xD;
      pelvic examination is done by subjective faculty assessment. This assessment is typically&#xD;
      performed at the end of the teaching block and is based on the assessors' recollection of the&#xD;
      students' performance. This kind of assessment has been shown to have poor validity and&#xD;
      reliability. This is in contrast to objective structured assessments of technical skill&#xD;
      (OSATS), which use task specific and global rating scales and have been used to evaluate a&#xD;
      wide range of clinical and surgical skills. However, no studies to date have evaluated an&#xD;
      assessment tool for pelvic examination. In this study the investigators aim to determine the&#xD;
      validity and reliability of an OSATS for pelvic examination. In addition, the investigators&#xD;
      aim to identify factors that influence the scores in OSATS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2013</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Validity of assessment tool</measure>
    <time_frame>Day 1</time_frame>
    <description>Both validity and reliability are of equal importance so there will be two primary outcomes. Validity will be tested using the proxy measure of construct validity. This will be demonstrated if the results of the OSATS reflect the participant experience.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reliability of assessment tool</measure>
    <time_frame>Day 1</time_frame>
    <description>Reliability will be measured using inter-rater reliability between 3 assessors who will be blinded to the other assessors' marks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Factors other than the stage in training that may influence proficiency in pelvic examination</measure>
    <time_frame>Day 1</time_frame>
    <description>We aim to identify other factors that may influence the participants' score in OSATS in pelvic examination. We will identify potential areas in a questionnaire administered to participant's prior the examination. This information will be collated before the examination in a participant information form. Information regarding gender, age, ethnicity, confidence in examination, interest in future career in obstetrics and gynaecology will be collected as secondary outcome measures.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Female Pelvic Examination</condition>
  <arm_group>
    <arm_group_label>Inexperienced students</arm_group_label>
    <description>Final year medical students at the end of the Obstetrics and Gynaecology placement</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experienced students</arm_group_label>
    <description>Final year medical students at the end of the Obstetrics and Gynaecology placement</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Junior Doctors</arm_group_label>
    <description>Pre Royal College of Obstetric and Gynaecology registered junior doctors with experience in Obstetrics and Gynaecology</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Observed Structured Assessment Tool in Pelvic Examination</intervention_name>
    <description>Participants will be asked to perform a pelvic examination including a speculum and bimanual examination on a pelvic model. They will be asked to approach the pelvic model as if it were a real patient.</description>
    <arm_group_label>Experienced students</arm_group_label>
    <arm_group_label>Inexperienced students</arm_group_label>
    <arm_group_label>Junior Doctors</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Medical students and junior doctors will be approached by the clinical sub dean for O&amp;G at&#xD;
        Birmingham Women's Hospital (Justin Clark - chief investigator) during the beginning of&#xD;
        their O&amp;G placement. They will be made aware that outcome and assessment as part of the&#xD;
        trial will not be incorporated into their final academic grade.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Final year medical students starting their Obstetrics and Gynaecology placement&#xD;
&#xD;
          -  Final year medical students finishing their Obstetrics and Gynaecology placement&#xD;
&#xD;
          -  Pre Royal College of Obstetrics and Gynaecology registered junior doctors doing a&#xD;
             Obstetrics and Gynaecology placement.&#xD;
&#xD;
          -  Signed Consent Form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas J Clark, MBChB MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Birmingham Women's NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Birmingham Womens Hospital</name>
      <address>
        <city>Birmingham</city>
        <state>West Midlands</state>
        <zip>B15 2TG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>June 2013</verification_date>
  <study_first_submitted>November 7, 2012</study_first_submitted>
  <study_first_submitted_qc>November 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>April 2, 2014</last_update_submitted>
  <last_update_submitted_qc>April 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 3, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Birmingham Women's NHS Foundation Trust</investigator_affiliation>
    <investigator_full_name>Thomas Justin Clark</investigator_full_name>
    <investigator_title>Consultant</investigator_title>
  </responsible_party>
  <keyword>OSAT</keyword>
  <keyword>Pelvic Examination</keyword>
  <keyword>Validation</keyword>
  <keyword>Reliability</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01725581
org study id: PEAT
nct id: NCT01725581
lead sponsor: 
has dmc: No
The purpose of this study is to show that a new assessment tool for pelvic examination is
      valid and reliable.
Physical examination of the pelvis is an important core skill that medical students need to
      acquire. However, due to its intimate nature some students are graduating unable to perform
      competent pelvic examinations. At present, evaluation of the medical students competence at
      pelvic examination is done by subjective faculty assessment. This assessment is typically
      performed at the end of the teaching block and is based on the assessors' recollection of the
      students' performance. This kind of assessment has been shown to have poor validity and
      reliability. This is in contrast to objective structured assessments of technical skill
      (OSATS), which use task specific and global rating scales and have been used to evaluate a
      wide range of clinical and surgical skills. However, no studies to date have evaluated an
      assessment tool for pelvic examination. In this study the investigators aim to determine the
      validity and reliability of an OSATS for pelvic examination. In addition, the investigators
      aim to identify factors that influence the scores in OSATS.
time perspective: Prospective
measure: Validity of assessment tool
time frame: Day 1
description: Both validity and reliability are of equal importance so there will be two primary outcomes. Validity will be tested using the proxy measure of construct validity. This will be demonstrated if the results of the OSATS reflect the participant experience.
measure: Reliability of assessment tool
time frame: Day 1
description: Reliability will be measured using inter-rater reliability between 3 assessors who will be blinded to the other assessors' marks.
measure: Factors other than the stage in training that may influence proficiency in pelvic examination
time frame: Day 1
description: We aim to identify other factors that may influence the participants' score in OSATS in pelvic examination. We will identify potential areas in a questionnaire administered to participant's prior the examination. This information will be collated before the examination in a participant information form. Information regarding gender, age, ethnicity, confidence in examination, interest in future career in obstetrics and gynaecology will be collected as secondary outcome measures.
arm group label: Inexperienced students
description: Final year medical students at the end of the Obstetrics and Gynaecology placement
arm group label: Experienced students
description: Final year medical students at the end of the Obstetrics and Gynaecology placement
arm group label: Junior Doctors
description: Pre Royal College of Obstetric and Gynaecology registered junior doctors with experience in Obstetrics and Gynaecology
intervention type: Procedure
intervention name: Observed Structured Assessment Tool in Pelvic Examination
description: Participants will be asked to perform a pelvic examination including a speculum and bimanual examination on a pelvic model. They will be asked to approach the pelvic model as if it were a real patient.
arm group label: Experienced students
arm group label: Inexperienced students
arm group label: Junior Doctors
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Thomas J Clark, MBChB MD
role: Principal Investigator
affiliation: Birmingham Women's NHS Foundation Trust
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Birmingham Women's NHS Foundation Trust
investigator full name: Thomas Justin Clark
investigator title: Consultant