NCT05607485

Brief Summary

The goal of this comparative blinded assessment study is to compare ratings of crowd workers and expert ratings in simulated robot-assisted radical prostatectomies The main question\[s\] it aims to answer are:

  • to examine the use of crowdsourced assessment for assessing the performance of robot-assisted rad-ical prostatectomy (RARP) compared with using experienced surgeons
  • to explore if some CW are better than others. Participants will assess edited videos of simulated robot assisted radical prostatecotmies using a standardized assessment tool. The laypersons will be asked to answer yes/no to the question: 'Would you trust this doctor to perform robot-assisted surgery on you?' after each surgery. All participants were blinded to the identity of the surgeon performing the videos of the robot-assisted radical prostatectomy Researchers will compare laypersons with expert raters to see if any difference between their ratings

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 7, 2022

Completed
Last Updated

November 7, 2022

Status Verified

November 1, 2022

Enrollment Period

10 months

First QC Date

October 26, 2022

Last Update Submit

November 3, 2022

Conditions

Keywords

CrowdsourcingAssessmentSurgical Education

Outcome Measures

Primary Outcomes (1)

  • to examine the use of crowdsourced assessment for assessing the performance of robot-assisted rad-ical prostatectomy (RARP) compared with using experienced surgeons

    To what degree do the GEARS scores correlate with experienced surgeons? A rating of 1 corresponds to the lowest level of performance, whereas a rating of 5 corresponds to the highest level of performance. An overall performance score is derived by summing the scores of each of the domains (5-25 points)by patients.

    immediately after the study completion

Secondary Outcomes (1)

  • To explore if some CW are better than others

    immediately after the study completion

Study Arms (1)

Crowd workers

OTHER

Crowd workers watched 10 (oiut 45 possible) random videos and assessed with a standard assessment tool. All participants were blinded to the identity and skill level of the surgeon

Procedure: Randomized video numbers

Interventions

See arm/group description

Crowd workers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Member of Forskningspanelet

You may not qualify if:

  • Under the age of 18
  • Expert raters
  • none
  • Senior surgeons in urology
  • Conducted \>50 robotic-assisted radical prostatectomy procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen Academy for Medical Education and Simulation

Copenhagen, Østerbro, 2100, Denmark

Location

Study Officials

  • Flemming Bjerrum, MD

    Copenhagen Academy for Medical Education and Simulation

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
All videos were blinded to the participants about the surgeon and the surgical skill level of the surgeon
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: comparative blinded assessment study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 26, 2022

First Posted

November 7, 2022

Study Start

April 1, 2021

Primary Completion

February 1, 2022

Study Completion

May 1, 2022

Last Updated

November 7, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations