<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/NCT02968407</url>
  </required_header>
  <id_info>
    <org_study_id>H-16031885</org_study_id>
    <nct_id>NCT02968407</nct_id>
  </id_info>
  <brief_title>Peer- and Self-rating of Open Surgery Skills</brief_title>
  <acronym>self-rate</acronym>
  <official_title>Peer- and Self-rating of Open Surgery Skills Using Objective Structured Assessment of Technical Skills</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Copenhagen Academy for Medical Education and Simulation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Copenhagen Academy for Medical Education and Simulation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study group want to investigate whether doctors, who are in the beginning of their&#xD;
      training to become surgeons, can rate themself and their peers using Objective Structured&#xD;
      Assessment of Technical Skills. Participants have participated in a 6 weeks course in basic&#xD;
      open surgical skills. At the end of the course the participants will be examined at at&#xD;
      videotaped test. The participants will be asked to rate their own video and two videos of&#xD;
      other trainees' performances. Ratings will be compared to expert ratings.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a prospective, descriptive study investigating whether doctors are able to rate&#xD;
      their own and their peers' performance in a basic open surgery skill course. At the end of&#xD;
      the course in basic open surgery, participants will be examined at the post-test as described&#xD;
      in the protocol &quot;The effect of group dynamics in surgical skill training&quot;. After the&#xD;
      participants complete the post-test, participants will be asked to participate in this&#xD;
      additional study. The participants will receive no instructions on this additional study,&#xD;
      before they complete the study &quot;The effect of group dynamics in surgical skill training&quot;.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">June 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Differences between the participants' rating score of his/her own performance and the experts' rating score of the participants' performance</measure>
    <time_frame>six months</time_frame>
    <description>To investigate whether medical doctors are able to rate their own performance in a basic open surgery skill course using a modified OSATS rating scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Differences between the participants' rating score of his/her peers performances and experts' rating score of the peers' performances</measure>
    <time_frame>six months</time_frame>
    <description>To investigate whether medical doctors are able to rate their peers' performance in a basic open surgery skill course using a modified OSATS rating scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences in the correlation of self-rating score and expert rating score between participants who are rated in the upper quartile by experts compared to participants who are rated in the lower quartile by experts</measure>
    <time_frame>Six months</time_frame>
    <description>To investigate the correlation between level of competency and the ability to self-rate in a basic open surgery skill course using a modified OSATS rating scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences in the correlation of participants' rating scores and experts' rating scores between participants first and second rating of their peers performance.</measure>
    <time_frame>six months</time_frame>
    <description>To investigate whether there is progression in the participants ability to rate their peers performances using OSATS</description>
  </secondary_outcome>
  <enrollment type="Actual">22</enrollment>
  <condition>Surgery</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Peer- and self-rating</intervention_name>
    <description>Participants will be given a print and a e-mail of the modified OSATS global rating scale and will be introduced to how the rating scale is used to rate technical performance. The participant will receive a USB stick each allowing the participant to see a video of his/her own performance and two videos from previous post-test performances from participants enrolled in the course. One video is a video of a participant who performed poorly,the other is from a participant who performed well. The participants will be asked to watch and rate the videos of their peers' performance first and afterwards watch and rate the participants own video performance. The investigators choose to let the participants rate their peers' performances before their own, so the participants will have the best opportunities to self-rate. Participants will be asked to email the results of their ratings to the principal investigator within 3 days. And expert in surgery will also rate the videos using OSATS.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Setting The participants will follow the basic open surgery skill course as described in&#xD;
        the protocol &quot;The effect of group dynamics in surgical skill training&quot;.&#xD;
&#xD;
        Participants Participants are medical doctors and medical students who completed the study&#xD;
        &quot;The effect of group dynamics in surgical skill training&quot; as part of the control group.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants are medical doctors and medical students who completed the study &quot;The&#xD;
             effect of group dynamics in surgical skill training&quot; as part of the control group.&#xD;
&#xD;
          -  The participants must be willing and able to give informed consent for participation&#xD;
             in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants who do not finish the basic open surgery course&#xD;
&#xD;
          -  Medical doctors and medical students enrolled in the study &quot;The effect of group&#xD;
             dynamics in surgical skill training&quot; that are randomized to dyad training&#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>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>July 24, 2017</last_update_submitted>
  <last_update_submitted_qc>July 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Copenhagen Academy for Medical Education and Simulation</investigator_affiliation>
    <investigator_full_name>Diana Haunstrup Bregner Overgaard</investigator_full_name>
    <investigator_title>Research Scholar</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>We plan to share the data within the study group</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Expected to be published during 2018</ipd_time_frame>
  </patient_data>
  <!-- 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/NCT02968407
org study id: H-16031885
nct id: NCT02968407
lead sponsor: 
has dmc: No
The study group want to investigate whether doctors, who are in the beginning of their
      training to become surgeons, can rate themself and their peers using Objective Structured
      Assessment of Technical Skills. Participants have participated in a 6 weeks course in basic
      open surgical skills. At the end of the course the participants will be examined at at
      videotaped test. The participants will be asked to rate their own video and two videos of
      other trainees' performances. Ratings will be compared to expert ratings.
The study is a prospective, descriptive study investigating whether doctors are able to rate
      their own and their peers' performance in a basic open surgery skill course. At the end of
      the course in basic open surgery, participants will be examined at the post-test as described
      in the protocol "The effect of group dynamics in surgical skill training". After the
      participants complete the post-test, participants will be asked to participate in this
      additional study. The participants will receive no instructions on this additional study,
      before they complete the study "The effect of group dynamics in surgical skill training".
observational model: Other
time perspective: Prospective
measure: Differences between the participants' rating score of his/her own performance and the experts' rating score of the participants' performance
time frame: six months
description: To investigate whether medical doctors are able to rate their own performance in a basic open surgery skill course using a modified OSATS rating scale
measure: Differences between the participants' rating score of his/her peers performances and experts' rating score of the peers' performances
time frame: six months
description: To investigate whether medical doctors are able to rate their peers' performance in a basic open surgery skill course using a modified OSATS rating scale
measure: Differences in the correlation of self-rating score and expert rating score between participants who are rated in the upper quartile by experts compared to participants who are rated in the lower quartile by experts
time frame: Six months
description: To investigate the correlation between level of competency and the ability to self-rate in a basic open surgery skill course using a modified OSATS rating scale
measure: Differences in the correlation of participants' rating scores and experts' rating scores between participants first and second rating of their peers performance.
time frame: six months
description: To investigate whether there is progression in the participants ability to rate their peers performances using OSATS
intervention type: Other
intervention name: Peer- and self-rating
description: Participants will be given a print and a e-mail of the modified OSATS global rating scale and will be introduced to how the rating scale is used to rate technical performance. The participant will receive a USB stick each allowing the participant to see a video of his/her own performance and two videos from previous post-test performances from participants enrolled in the course. One video is a video of a participant who performed poorly,the other is from a participant who performed well. The participants will be asked to watch and rate the videos of their peers' performance first and afterwards watch and rate the participants own video performance. The investigators choose to let the participants rate their peers' performances before their own, so the participants will have the best opportunities to self-rate. Participants will be asked to email the results of their ratings to the principal investigator within 3 days. And expert in surgery will also rate the videos using OSATS.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Copenhagen Academy for Medical Education and Simulation
investigator full name: Diana Haunstrup Bregner Overgaard
investigator title: Research Scholar
sharing ipd: Yes
ipd description: We plan to share the data within the study group
ipd info type: Study Protocol
ipd time frame: Expected to be published during 2018