Effectiveness of an Artificial Intelligent Tutoring System in Simulation Training

Comparing the Virtual Operative Assistant to Expert-based Instruction in Surgical Education: A Randomized Controlled Trial

Brief Summary:

Background:

Although surgical experience and technical skill are associated with better patient outcomes, quantitating surgical ability in the operating room is challenging. In surgical education, large datasets generated by high-fidelity virtual reality simulators can be employed by machine learning algorithms to objectively measure trainee performance and competence on expert benchmarks. This allows repetitive practice of surgical skills in safe and risk-free environments with immediate feedback.

Our group developed and has a patent pending for an intelligent tutoring system called the Virtual Operative Assistant (VOA). Utilizing an Artificial Intelligence (AI) support vector machine algorithm, the VOA assesses data derived from the NeuroVR (CAE Healthcare) simulator platform and provides individualized audiovisual feedback to improve learner performance during simulated brain tumor resections. The effectiveness of intelligent tutoring systems such as the VOA to the human surgical apprenticeship pedagogy remains to be elucidated.

The aim of this study is to compare the effectiveness and educational impact of personalized VOA feedback to expert instruction on medical student's technical skills learning of a virtual reality tumor resection procedure.

Specific Aims: 1) To assess if medical students receiving personalized VOA feedback statistically improve their surgical performance when compared to those having (a) no expert instructor feedback or (b) expert instructor-mediated feedback. 2) To outline if different emotions are elicited by the VOA intelligent tutoring system in medical students while performing this achievement task as compared to human instruction

Study Overview

• Status: Completed
• Conditions: Surgical Education
• Intervention / Treatment: Behavioral: Virtual Operative Assistant Training; Behavioral: Remote-Based Expert Instructor Training

Detailed Description

Design: A three-arm partially blinded randomized controlled trial of VOA training versus remote-based expert instruction versus control.

Setting: Neurosurgical Simulation and Artificial Intelligence Learning Centre, Montreal Neurological Institute.

Participants: Eligible first- and second-year medical students from across the province of Quebec.

Task: Complete removal of a simulated tumour - distinguishable by colour and haptic properties - with minimal bleeding and damage to surrounding healthy brain using two surgical instruments (Cavitron Ultrasonic Aspirator and Bipolar pincers) of the NeuroVR (CAE Healthcare) surgical simulator.

Intervention: A single 75-minute training session, including six virtual subpial tumour resection attempts (five simple practice scenarios and one complex realistic scenario) with assessment and feedback from either:

1. the VOA intelligent tutoring system (Group 2) or

2. a remote-based expert instructor (Group 3)

   Both compared to:

3. control group (Group 1) that receives no assessment or performance feedback.

To our knowledge this will be the first study to compare the effectiveness of an AI-powered intelligent tutoring system to expert instruction in the context of medical and surgical virtual reality simulation and assess the emotional response to such instruction. This study aims to begin to identify successful approaches to use this innovative technology in the medical educational curriculum and improve patient outcomes by augmenting safety, efficiency and competency of surgeons and other healthcare providers.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3A 2B4
      • Neurosurgical Simulation and Artificial Intelligence Learning Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:• First- and second-year medical students from any Canadian institution who do not meet the exclusion criteria.

-

Exclusion Criteria: • Participation in any of our group's previous trials involving the NeuroVR (CAE Healthcare) simulator.

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Control Group - Baseline Training 25 Participants allocated. Individuals receive introductory information on using the simulator and the scenario. They perform 5 simple subpial tumour resections for practice and have 5 minutes per trial. After each attempt, the student takes a 5-minute break with no assessment or feedback on their performance. On their 6th attempt they have 13 minutes to perform a different realistic scenario.
Experimental: Experimental Group - Virtual Operative Assistance Training; Experimental Group - Virtual Operative Assistance Training 25 participants allocated. Individuals receive the same information, have the same amount of time and perform the same scenarios as the control group. In the 5-minutes between attempts, participant receive the Virtual Operative Assistance Training assessment of their performance and audiovisual feedback.	Behavioral: Virtual Operative Assistant Training; Individuals receive the same basic information, have the same amount of time and perform the same scenarios as the control group. In the 5-minutes between attempts, participant receive the Virtual Operative Assistant assessment of their performance and audiovisual feedback.
Experimental: Experimental Group - remote-based expert Instructor Training; 25 participants allocated. Individuals receive the same information, have the same amount of time and perform the same scenarios as the control group. Meanwhile, a trained instructor observes the participant's on-screen performance, that is live-streamed, remotely. Instructors are senior neurosurgery residents with extensive experience in performing and assessing this scenario. During the 5-minute feedback session, they chat with the student, discussing the performance and help in setting goals for the next trial.	Behavioral: Remote-Based Expert Instructor Training; Individuals receive the same information, have the same amount of time and perform the same scenarios as the control group. Meanwhile, a trained instructor observes the participant's on-screen performance, that is live-streamed, remotely. Instructors are senior neurosurgery residents with extensive experience in performing and assessing this scenario. During the 5-minute feedback session, they chat with the student, discussing the performance and help in setting goals for the next trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in procedural performance .	Performance in each practice attempt is measured utilizing raw data from the simulator that is used for assessment by previously established AI algorithms on validated metrics.	Day of Study
Change in learning	Performance on the complex realistic scenario is evaluated by expert instructors using the Objective Structured Assessments of technical Skills (OSATS) Visual Rating Scale (weighted at 50%) and the AI assessment algorithms (weighted at 50%) creating a composite performance score.	Day of Study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in the strength of emotions elicited	Measured using Duffy's Medical Emotions Scale (MES), before, during and after the intervention.	Day of Study
Difference in cognitive load	Measured using Leppink's Cognitive Load Index (CLI) after the intervention.	Day of Study

Collaborators and Investigators

• Sponsor: McGill University

Publications and helpful links

General Publications

• Stulberg JJ, Huang R, Kreutzer L, Ban K, Champagne BJ, Steele SR, Johnson JK, Holl JL, Greenberg CC, Bilimoria KY. Association Between Surgeon Technical Skills and Patient Outcomes. JAMA Surg. 2020 Oct 1;155(10):960-968. doi: 10.1001/jamasurg.2020.3007. Erratum In: JAMA Surg. 2020 Oct 1;155(10):1002. JAMA Surg. 2021 Jul 1;156(7):694.
• Birkmeyer JD, Finks JF, O'Reilly A, Oerline M, Carlin AM, Nunn AR, Dimick J, Banerjee M, Birkmeyer NJ; Michigan Bariatric Surgery Collaborative. Surgical skill and complication rates after bariatric surgery. N Engl J Med. 2013 Oct 10;369(15):1434-42. doi: 10.1056/NEJMsa1300625.
• Birkmeyer JD, Stukel TA, Siewers AE, Goodney PP, Wennberg DE, Lucas FL. Surgeon volume and operative mortality in the United States. N Engl J Med. 2003 Nov 27;349(22):2117-27. doi: 10.1056/NEJMsa035205.
• Winkler-Schwartz A, Yilmaz R, Mirchi N, Bissonnette V, Ledwos N, Siyar S, Azarnoush H, Karlik B, Del Maestro R. Machine Learning Identification of Surgical and Operative Factors Associated With Surgical Expertise in Virtual Reality Simulation. JAMA Netw Open. 2019 Aug 2;2(8):e198363. doi: 10.1001/jamanetworkopen.2019.8363.
• Mirchi N, Bissonnette V, Yilmaz R, Ledwos N, Winkler-Schwartz A, Del Maestro RF. The Virtual Operative Assistant: An explainable artificial intelligence tool for simulation-based training in surgery and medicine. PLoS One. 2020 Feb 27;15(2):e0229596. doi: 10.1371/journal.pone.0229596. eCollection 2020.
• Winkler-Schwartz A, Marwa I, Bajunaid K, Mullah M, Alotaibi FE, Bugdadi A, Sawaya R, Sabbagh AJ, Del Maestro R. A Comparison of Visual Rating Scales and Simulated Virtual Reality Metrics in Neurosurgical Training: A Generalizability Theory Study. World Neurosurg. 2019 Jul;127:e230-e235. doi: 10.1016/j.wneu.2019.03.059. Epub 2019 Mar 15.
• Duffy, M.C., et al., Emotions in medical education: Examining the validity of the Medical Emotion Scale (MES) across authentic medical learning environments. Learning and Instruction, 2020. 70: p. 101150.
• Leppink J, Paas F, Van der Vleuten CP, Van Gog T, Van Merrienboer JJ. Development of an instrument for measuring different types of cognitive load. Behav Res Methods. 2013 Dec;45(4):1058-72. doi: 10.3758/s13428-013-0334-1.
• Fazlollahi AM, Bakhaidar M, Alsayegh A, Yilmaz R, Winkler-Schwartz A, Mirchi N, Langleben I, Ledwos N, Sabbagh AJ, Bajunaid K, Harley JM, Del Maestro RF. Effect of Artificial Intelligence Tutoring vs Expert Instruction on Learning Simulated Surgical Skills Among Medical Students: A Randomized Clinical Trial. JAMA Netw Open. 2022 Feb 1;5(2):e2149008. doi: 10.1001/jamanetworkopen.2021.49008.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2021
• Primary Completion (Actual): May 15, 2021
• Study Completion (Actual): May 15, 2021

Study Registration Dates

• First Submitted: January 6, 2021
• First Submitted That Met QC Criteria: January 6, 2021
• First Posted (Actual): January 7, 2021

Study Record Updates

• Last Update Posted (Actual): May 24, 2021
• Last Update Submitted That Met QC Criteria: May 20, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Virtual Reality; Simulation
• Other Study ID Numbers: 2010-270, NEU-09-042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data obtained from primary and secondary outcomes may be shared if other researchers have an interest in this data
• IPD Sharing Time Frame: Data will be available for 5 years after completion of trial
• IPD Sharing Access Criteria: Researchers wanting access to the data will need to contact the principal investigator of the trial. Dr. Rolando Del Maestro
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No