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临床试验/NCT05607485
NCT05607485已完成不适用

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

Copenhagen Academy for Medical Education and Simulation2 个研究点 分布在 1 个国家目标入组 151 人开始时间: 2021年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
151
试验地点
2
主要终点
to examine the use of crowdsourced assessment for assessing the performance of robot-assisted rad-ical prostatectomy (RARP) compared with using experienced surgeons

研究概览

简要总结

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

详细描述

3. 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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

盲法说明

All videos were blinded to the participants about the surgeon and the surgical skill level of the surgeon

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion Criteria:
  • Member of Forskningspanelet

排除标准

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

结局指标

主要结局

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

时间窗: 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.

次要结局

  • To explore if some CW are better than others(immediately after the study completion)

研究者

发起方
Copenhagen Academy for Medical Education and Simulation
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rikke Groth Olsen

Principal Investigator

Copenhagen Academy for Medical Education and Simulation

研究点 (2)

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