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.
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
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
- 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.
- 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.
- Conditions
- Clinical Competence
- 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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Randomized video numbers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted7 Nov 2022
- Study start1 Apr 2021
- Primary completion1 Feb 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical CompetenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Copenhagen Academy for Medical Education and Simulation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rikke Groth Olsen, Copenhagen Academy for Medical Education and Simulation
- Investigators
- Flemming Bjerrum, MD, Study chair, Copenhagen Academy for Medical Education and Simulation
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laypersons Cannot Select Preferred Surgeon Based on Videos of Simulated Robot-assisted Radical Prostatectomies
- ClinicalTrials.gov ID
- NCT05607485
- Acronym / sponsor ID
- P-2020-701
- Conditions
- Clinical Competence
- Keywords
- Crowdsourcing, Assessment, Surgical Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Copenhagen Academy for Medical Education and SimulationUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 7 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
- 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.
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- comparative blinded assessment study
| Arm | Type | Receives |
|---|---|---|
| Crowd workers | Other | Procedure: Randomized video numbersCrowd 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Member of Forskningspanelet
- none
Key exclusion criteria (4 listed)
- Under the age of 18
- Expert raters
- Senior surgeons in urology
- Conducted >50 robotic-assisted radical prostatectomy procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Randomized video numbersSee arm/group description | Procedure or surgery | Crowd workers |
Primary outcome
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
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.
1 secondary outcome
To explore if some CW are better than others
Time frame: immediately after the study completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Flemming Bjerrum, MD study chair
Copenhagen Academy for Medical Education and Simulation
1 site in 1 country: see every site and its status.
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.