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Clinical CompetenceNCT05607485

Laypersons Cannot Select Preferred Surgeon Based on Videos of Simulated Robot-assisted Radical Prostatectomies

A study testing Randomized video numbers in people with Clinical Competence, run by Copenhagen Academy for Medical Education and Simulation at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Clinical Competence
What is being tested?
Randomized video numbers
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
151 participants
Where
1 siteDenmark
Study dates
1 Apr 2021to 1 May 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Member of Forskningspanelet
  • none

Who cannot join

  • Under the age of 18
  • Expert raters
  • Senior surgeons in urology
  • Conducted >50 robotic-assisted radical prostatectomy procedures

Trial locations and contacts

1 site in 1 country.

Denmark1 site
  • Copenhagen Academy for Medical Education and Simulation

    Copenhagen, Østerbro, 2100

Other trials in Denmark

About this study

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
Read the detailed description
  1. Trial design 3.1 Content This study will evaluate global robotic skills for the three modules performed on the RobotiX, Sim-bionix: bladder neck dissection, nerve sparring dissection, and ureterovesical anastomosis all recorded from the previous study: 'Validation of a novel simulation-based test in robot-assisted radical prostatectomy.' 3.2 Response process Experienced surgeons and crowd workers will first be presented with a short, written instruction describing the trial. Before enrolment all participants will have signed an informed consent (appendix 2) and a demographic questionnaire for baseline characteristics of the crowd and surgical experience of the experienced surgeons (Appendix 3). After completion of the informed consent and demographic questionnaire the survey links will be sent to the participants. Afterwards, both crowd raters and experts will be trained on how to assess the videos with use of the assessment tool, mGEARS. mGEARS is composed of 5 domains: depth perception, bimanual dexterity, efficiency, force sensitivity, and robotic control. Performance in each domain is measured on a 5-point Likert scale. 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 (25 points). The raters will have time to read and understand the assessment tool before rating the videos. An elaborate explanation of the chosen domains will be given to the raters including how to rate each video.

3.4 Video material The participants will be assessing the videos using the assessment tool in a survey sent by E-boks. The surveys will be sent using a URL-link from Redcap. All videos are stored at 23video system and a link to the videos will be included in the survey. The survey has successfully been tested on different devices.

The investigators will randomly choose videos from the third repetition from 5 novice surgeons, 5 experienced robotic surgeons and 5 experienced robotic surgeons in RARP. The investigators will use edited videos to the length of maximum 5 minutes. The videos will be edited from start (0 minutes) and 5 minutes forward, where the video will be stopped. Therefore, the videos will show how far the surgeon has come after 5 minutes of simulated operation. A total of 4548 edited videos will be used for crowd-sourced assessment.

To secure response process of Messick's framework all participants will be blinded to the identity and skill level of the surgeon on the recorded video. The experienced surgeons could potentially rate their own videos, which could be a threat to validity for the response process, but as the vide-os are blinded, they will not know which videos are their own. In addition, there will be a signifi-cant time delay between them having performed the task and rating the videos. Thus, it is unlikely that they will be able to identify their own videos. All videos will be given a randomly allocated identification ID.

3.5 Video-rating Each participant will rate ten randomly chosen videos using GEARS. The participants will be given a randomized ID number, which is used to match the ten videos to the participant. They will be asked to evaluate each video with the five different domains of GEARS on a scale from one to five. After rating the video, the participant will be asked to answer 'yes' or 'no' to the question: 'Would the participant trust this doctor to operate on he participant, if the participant were to have their prostate removed using robotic-assisted surgery?'. The participants will fill in the answers after the video-rating in RedCap.

3.6 Evaluation questions After the crowd-raters finish the video-ratings, they will receive a final questionnaire in RedCap, where they are asked their opinion about a possible future role as crowd-raters regarding time use and possible payment level (appendix 4).

3.7 Data-collection All data will be collected and stored in RedCap, which is a platform designed to store research data. All data will be pseudo anonymized as all participants will get a unique link only known to the participant and the principal investigator (RGO). The participants can only rate the video once. The data will be blinded by RGO prior to statistical analysis.

  1. Selection of participants The crowd workers will be recruited by a Danish Association for volunteer patients who would like to contribute to research, Forskningspanelet. e-mail, Facebook, at the website of the Danish prostate cancer association (PROPA) or the monthly PROPA membership magazine.

The expert panel will be invited by e-mail.

Being tested
Randomized video numbers
Keywords
Crowdsourcing, Assessment, Surgical Education

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Randomized video numbersProcedure or surgery

    See arm/group description

Study groups in NCT05607485
Study groupRoleWhat they receive
Crowd workersOtherCrowd 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
Receives: Procedure: Randomized video numbers

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: immediately after the study completion

Secondary outcomes (1)
  1. To explore if some CW are better than others

    Does some CW perform closer to the expert raters than others (stratified by age, gender, education in the medical field yes/no)

    Measured: immediately after the study completion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2022
  2. Study start1 Apr 2021
  3. Primary completion1 Feb 2022
  4. Study completion1 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
comparative blinded assessment study
Masking
None (open label)
Enrolment
151 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05607485
Sponsor's protocol ID
P-2020-701
Status last verified
Nov 2022
First submitted
26 Oct 2022
Last updated
7 Nov 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Randomized video numbers in people with Clinical Competence, run by Copenhagen Academy for Medical Education and Simulation at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

to examine the use of crowdsourced assessment for assessing the performance of robot-assisted rad-ical prostatectomy (RARP) compared with using experienced surgeons (time frame: immediately after the study completion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2022.

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