Simulation-based Arthroscopic Surgery Study

• Sponsor: University of Oxford (Other)
• Overall Status: Completed
• CT.gov ID: NCT02777333
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 18
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether simulation training improves the performance during arthroscopic surgery ('keyhole' surgery into a joint).

Condition or Disease	Intervention/Treatment	Phase
Arthroscopy Training	Behavioral: Simulation training	N/A

Detailed Description

This single blinded randomised controlled study of junior orthopaedic trainees aims to assess whether the addition of simulation training improves arthroscopic technical skills performance of junior orthopaedic trainees during knee arthroscopy in the operating theatre compared to their usual clinical training programme. This will be assessed using objective motion analysis parameters recorded from wireless elbow-mounted motion sensors during surgery.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Simulation-based Arthroscopic Surgery Study
• Study Start Date: Jan 1, 2016
• Actual Primary Completion Date: Jul 1, 2017
• Actual Study Completion Date: Jul 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Simulation training Addition of simulation training during usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme	Behavioral: Simulation training; Simulation training in a skills lab for 1 hour per week over 13 weeks on dry, bench-top box trainers and anatomical simulators
No Intervention: Non-simulation/Routine training Usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme

Outcome Measures

Primary Outcome Measures

1. Number of Hand Movements Required by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre [3 months]

   Wireless elbow-mounted accelerometer and gyroscopic sensors worn by the participant will generate 6 degree of freedom motion data (three rotational degrees around the x, y and z axes, known as 'roll', 'pitch', and 'yaw', and three translational degrees of freedom along x, y and z axes, known as 'surge', 'sway' and 'heave') which will be analysed using validated, bespoke algorithms to calculate the number of hand movements taken whilst performing a diagnostic knee arthroscopy according to a standardised protocol.

Secondary Outcome Measures

1. Smoothness of Hand Movements by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre [3 months]

   Wireless elbow-mounted accelerometer and gyroscopic sensors worn by the participant will generate 6 degree of freedom motion data which will be analysed using validated, bespoke algorithms to calculate the smoothness (also known as 'jerk', the first derivative of acceleration by time, or third derivative of distance by time) of hand movements taken whilst performing a diagnostic knee arthroscopy according to a standardised protocol according to a standardised protocol.

2. Time Taken by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre [3 months]

   Wireless elbow-mounted accelerometer and gyroscopic sensors worn by the participant will generate 6 degree of freedom motion data which will be analysed using validated, bespoke algorithms. These data will also collect time signatures, which can be used to work out the time taken by participants to perform a diagnostic arthroscopy of the knee in theatre according to a standardised protocol.

3. Minor Hand Movements Required by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre [3 months]

   Wireless elbow-mounted accelerometer and gyroscopic sensors worn by the participant will generate 6 degree of freedom motion data (three rotational degrees around the x, y and z axes, known as 'roll', 'pitch', and 'yaw', and three translational degrees of freedom along x, y and z axes, known as 'surge', 'sway' and 'heave') which will be analysed using validated, bespoke algorithms to calculate the number of movements (below the threshold for 'hand movements' above in outcome 1, but above the data noise threshold) taken whilst performing a diagnostic knee arthroscopy according to a standardised protocol.

4. Stationary Time of Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre [3 months]

   Wireless elbow-mounted accelerometer and gyroscopic sensors worn by the participant will generate 6 degree of freedom motion data which will be analysed using validated, bespoke algorithms. These data will also collect time signatures, which can be used to work out the length of time during the procedure where each hand is stationary while participants perform a diagnostic arthroscopy of the knee in theatre according to a standardised protocol.

5. Idle Time of Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre [3 months]

   Wireless elbow-mounted accelerometer and gyroscopic sensors worn by the participant will generate 6 degree of freedom motion data which will be analysed using validated, bespoke algorithms. These data will also collect time signatures, which can be used to work out the length of time during the procedure where both hands are stationary at the same time while participants perform a diagnostic arthroscopy of the knee in theatre according to a standardised protocol.

6. Dominance of Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre [3 months]

   Wireless elbow-mounted accelerometer and gyroscopic sensors worn by the participant will generate 6 degree of freedom motion data which will be analysed using validated, bespoke algorithms. These data will be analysed for the relative activity and dominance of each hand during the procedure while participants perform a diagnostic arthroscopy of the knee in theatre according to a standardised protocol.

7. Global Rating Scale Performance During Diagnostic Knee Arthroscopy in Theatre [3 months]

   Validated global rating scale for assessing diagnostic knee arthroscopy performance

8. Deviation From 'Idealised' Motion Parameters for Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre [3 months]

   Previously described motion parameters of participants performing a diagnostic knee arthroscopy in theatre (see Primary outcome 1, and secondary outcomes 2-8) reported as a ratio to the 'ideal' performance as measured from the supervising clinician performing an optimal diagnostic knee arthroscopy on the same patient as the participant while wearing the wireless elbow-mounted accelerometer and gyroscopic sensors which will record 6 degree of freedom motion data to allow calculation of 'number of hand movements', 'smoothness', 'time taken', 'minor hand movements', 'stationary time', 'idle time' and dominance'

9. Motion Analysis Parameters During Simulation [3 months]

   Change in participant performance on dry, bench top box trainers and anatomical simulators between baseline and 3 months using motion analysis parameters described in Primary outcome 1 and secondary outcomes 2-8 as measured by wireless elbow-mounted accelerometer and gyroscopic sensors

10. Resting State Network Functional Changes on fMRI (Functional Magnetic Resonance Imaging) [3 months]

    Use of MELODIC (Multivariate Exploratory Linear Optimized Decomposition into Independent Components) to identify resting state networks, and analyse differences in functional connectivity at baseline and three months between the intervention and control arms.

11. Voxel Based Morphometry Structural Changes on fMRI (Functional Magnetic Resonance Imaging) [3 months]

    Using FSLVBM (fMRIB's Software Library Voxel Based Morphometry) to calculate voxel-wise changes in grey matter volumes at baseline and three months between the intervention and control arms. Changes in VBM imply changes in grey matter volume and represent structural brain change.

12. Diffusion Tractography Structural Changes on fMRI (Functional Magnetic Resonance Imaging) [3 months]

    Using FDT (fMRIB's Diffusion Toolbox) to model local diffusion and changes in tractography at baseline and three months between the intervention and control arms. Changes in diffusion imply micro-structural (axonal) connectivity and represent structural brain change.

13. Quantitative Magnetisation Transfer Structural Changes on fMRI (Functional Magnetic Resonance Imaging) [3 months]

    Quantitative magnetisation transfer imaging estimates liquid and semisolid (macromolecular) constituents of tissue at baseline and three months between the intervention and control arms. Changes in macromolecular content imply micro-structural (myelin) connectivity and represent structural brain change.

14. Feasibility of Additional Simulation Training [3 months]

    Qualitative survey of participants opinions of the addition of simulation to their usual clinical training programme

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Participant is willing and able to give informed consent for participation in the study.

• Healthy adults, Male or Female, aged 18 years or above.

• Enrolled in Health Education Thames Valley/Oxford Deanery Training Programme in junior surgical training posts

Exclusion Criteria:

• Unwilling or unable to provide informed consent

• Previously completed higher surgical training programme

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nuffield Orthopaedic Centre	Oxford	Oxfordshire	United Kingdom	OX3 7LD

Sponsors and Collaborators

• University of Oxford

Investigators

• Principal Investigator: Jonathan L Rees, FRCS-Tr&Orth, University of Oxford

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 16, 2015

More Information

Additional Information:

• Research group web page

Publications

None provided.

• Responsible Party: University of Oxford
• ClinicalTrials.gov Identifier: NCT02777333
• Other Study ID Numbers: MSD-IDREC-C1-2014-152
• First Posted: May 19, 2016
• Last Update Posted: Jun 18, 2021
• Last Verified: May 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by University of Oxford: Simulation; Arthroscopy; Motion analysis

Study Results

Participant Flow

Recruitment Details	SHO trainees (PGY 2-3 equivalent) within nationally approved T&O training rotations at an English teaching hospital were eligible for inclusion. Exclusions; more than 2 years of surgical training; previous admission to a higher surgical training program; performed or assisted in over 10 arthroscopic or minimal-access procedures.

Arm/Group Title	Simulation Training	Non-simulation/Routine Training
Arm/Group Description	Addition of simulation training during usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme Simulation training: Simulation training in a skills lab for 1 hour per week over 13 weeks on dry, bench-top box trainers and anatomical simulators	Usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme
Period Title: Overall Study
STARTED	15	15
COMPLETED	15	13
NOT COMPLETED	0	2

Baseline Characteristics

Arm/Group Title	Simulation Training	Non-simulation/Routine Training	Total
Arm/Group Description	Addition of simulation training during usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme Simulation training: Simulation training in a skills lab for 1 hour per week over 13 weeks on dry, bench-top box trainers and anatomical simulators	Usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme	Total of all reporting groups
Overall Participants	15	15	30
Age (years) [Mean (Inter-Quartile Range) ]
Mean (Inter-Quartile Range) [years]	26.02	26.34	26.18
Sex: Female, Male (Count of Participants)
Female	8 53.3%	6 40%	14 46.7%
Male	7 46.7%	9 60%	16 53.3%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Postgraduate year (Count of Participants)
PGY2	12 80%	12 80%	24 80%
PGY3	3 20%	3 20%	6 20%

Outcome Measures

1. Primary Outcome

Title	Number of Hand Movements Required by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre
Description	Wireless elbow-mounted accelerometer and gyroscopic sensors worn by the participant will generate 6 degree of freedom motion data (three rotational degrees around the x, y and z axes, known as 'roll', 'pitch', and 'yaw', and three translational degrees of freedom along x, y and z axes, known as 'surge', 'sway' and 'heave') which will be analysed using validated, bespoke algorithms to calculate the number of hand movements taken whilst performing a diagnostic knee arthroscopy according to a standardised protocol.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Simulation Training	Non-simulation/Routine Training
Arm/Group Description	Addition of simulation training during usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme Simulation training: Simulation training in a skills lab for 1 hour per week over 13 weeks on dry, bench-top box trainers and anatomical simulators	Usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme
Measure Participants	15	13
Median (Inter-Quartile Range) [hand movements]	544	893

2. Secondary Outcome

Title	Smoothness of Hand Movements by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre
Description	Wireless elbow-mounted accelerometer and gyroscopic sensors worn by the participant will generate 6 degree of freedom motion data which will be analysed using validated, bespoke algorithms to calculate the smoothness (also known as 'jerk', the first derivative of acceleration by time, or third derivative of distance by time) of hand movements taken whilst performing a diagnostic knee arthroscopy according to a standardised protocol according to a standardised protocol.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Simulation Training	Non-simulation/Routine Training
Arm/Group Description	Addition of simulation training during usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme Simulation training: Simulation training in a skills lab for 1 hour per week over 13 weeks on dry, bench-top box trainers and anatomical simulators	Usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme
Measure Participants	15	13
Median (Inter-Quartile Range) [ms^-3]	25,842	36,846

3. Secondary Outcome

Title	Time Taken by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre
Description	Wireless elbow-mounted accelerometer and gyroscopic sensors worn by the participant will generate 6 degree of freedom motion data which will be analysed using validated, bespoke algorithms. These data will also collect time signatures, which can be used to work out the time taken by participants to perform a diagnostic arthroscopy of the knee in theatre according to a standardised protocol.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Simulation Training	Non-simulation/Routine Training
Arm/Group Description	Addition of simulation training during usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme Simulation training: Simulation training in a skills lab for 1 hour per week over 13 weeks on dry, bench-top box trainers and anatomical simulators	Usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme
Measure Participants	15	13
Median (Inter-Quartile Range) [seconds]	320	573

4. Secondary Outcome

Title	Minor Hand Movements Required by Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre
Description	Wireless elbow-mounted accelerometer and gyroscopic sensors worn by the participant will generate 6 degree of freedom motion data (three rotational degrees around the x, y and z axes, known as 'roll', 'pitch', and 'yaw', and three translational degrees of freedom along x, y and z axes, known as 'surge', 'sway' and 'heave') which will be analysed using validated, bespoke algorithms to calculate the number of movements (below the threshold for 'hand movements' above in outcome 1, but above the data noise threshold) taken whilst performing a diagnostic knee arthroscopy according to a standardised protocol.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Simulation Training	Non-simulation/Routine Training
Arm/Group Description	Addition of simulation training during usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme Simulation training: Simulation training in a skills lab for 1 hour per week over 13 weeks on dry, bench-top box trainers and anatomical simulators	Usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme
Measure Participants	15	13
Median (Inter-Quartile Range) [minor hand movements]	176	435

5. Secondary Outcome

Title	Stationary Time of Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre
Description	Wireless elbow-mounted accelerometer and gyroscopic sensors worn by the participant will generate 6 degree of freedom motion data which will be analysed using validated, bespoke algorithms. These data will also collect time signatures, which can be used to work out the length of time during the procedure where each hand is stationary while participants perform a diagnostic arthroscopy of the knee in theatre according to a standardised protocol.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

Data were not collected

Arm/Group Title	Simulation Training	Non-simulation/Routine Training
Arm/Group Description	Addition of simulation training during usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme Simulation training: Simulation training in a skills lab for 1 hour per week over 13 weeks on dry, bench-top box trainers and anatomical simulators	Usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme
Measure Participants	0	0

6. Secondary Outcome

Title	Idle Time of Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre
Description	Wireless elbow-mounted accelerometer and gyroscopic sensors worn by the participant will generate 6 degree of freedom motion data which will be analysed using validated, bespoke algorithms. These data will also collect time signatures, which can be used to work out the length of time during the procedure where both hands are stationary at the same time while participants perform a diagnostic arthroscopy of the knee in theatre according to a standardised protocol.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

Data were not collected

Arm/Group Title	Simulation Training	Non-simulation/Routine Training
Arm/Group Description	Addition of simulation training during usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme Simulation training: Simulation training in a skills lab for 1 hour per week over 13 weeks on dry, bench-top box trainers and anatomical simulators	Usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme
Measure Participants	0	0

7. Secondary Outcome

Title	Dominance of Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre
Description	Wireless elbow-mounted accelerometer and gyroscopic sensors worn by the participant will generate 6 degree of freedom motion data which will be analysed using validated, bespoke algorithms. These data will be analysed for the relative activity and dominance of each hand during the procedure while participants perform a diagnostic arthroscopy of the knee in theatre according to a standardised protocol.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

8. Secondary Outcome

Title	Global Rating Scale Performance During Diagnostic Knee Arthroscopy in Theatre
Description	Validated global rating scale for assessing diagnostic knee arthroscopy performance
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

Data were not collected

Arm/Group Title	Simulation Training	Non-simulation/Routine Training
Arm/Group Description	Addition of simulation training during usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme Simulation training: Simulation training in a skills lab for 1 hour per week over 13 weeks on dry, bench-top box trainers and anatomical simulators	Usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme
Measure Participants	0	0

9. Secondary Outcome

Title	Deviation From 'Idealised' Motion Parameters for Participants to Perform a Diagnostic Arthroscopy of the Knee in Theatre
Description	Previously described motion parameters of participants performing a diagnostic knee arthroscopy in theatre (see Primary outcome 1, and secondary outcomes 2-8) reported as a ratio to the 'ideal' performance as measured from the supervising clinician performing an optimal diagnostic knee arthroscopy on the same patient as the participant while wearing the wireless elbow-mounted accelerometer and gyroscopic sensors which will record 6 degree of freedom motion data to allow calculation of 'number of hand movements', 'smoothness', 'time taken', 'minor hand movements', 'stationary time', 'idle time' and dominance'
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Simulation Training	Non-simulation/Routine Training
Arm/Group Description	Addition of simulation training during usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme Simulation training: Simulation training in a skills lab for 1 hour per week over 13 weeks on dry, bench-top box trainers and anatomical simulators	Usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme
Measure Participants	15	13
Ratio of Hand movements	1.9	3.3
Ratio of Minor hand movements	3.8	10.3
Ratio of Smoothness	1.2	2.6
Ratio of Time taken	2.1	4.3

10. Secondary Outcome

Title	Motion Analysis Parameters During Simulation
Description	Change in participant performance on dry, bench top box trainers and anatomical simulators between baseline and 3 months using motion analysis parameters described in Primary outcome 1 and secondary outcomes 2-8 as measured by wireless elbow-mounted accelerometer and gyroscopic sensors
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Simulation Training	Non-simulation/Routine Training
Arm/Group Description	Addition of simulation training during usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme Simulation training: Simulation training in a skills lab for 1 hour per week over 13 weeks on dry, bench-top box trainers and anatomical simulators	Usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme
Measure Participants	15	15
Median (Inter-Quartile Range) [Hand movements]	131	249

11. Secondary Outcome

Title	Resting State Network Functional Changes on fMRI (Functional Magnetic Resonance Imaging)
Description	Use of MELODIC (Multivariate Exploratory Linear Optimized Decomposition into Independent Components) to identify resting state networks, and analyse differences in functional connectivity at baseline and three months between the intervention and control arms.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

12. Secondary Outcome

Title	Voxel Based Morphometry Structural Changes on fMRI (Functional Magnetic Resonance Imaging)
Description	Using FSLVBM (fMRIB's Software Library Voxel Based Morphometry) to calculate voxel-wise changes in grey matter volumes at baseline and three months between the intervention and control arms. Changes in VBM imply changes in grey matter volume and represent structural brain change.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

13. Secondary Outcome

Title	Diffusion Tractography Structural Changes on fMRI (Functional Magnetic Resonance Imaging)
Description	Using FDT (fMRIB's Diffusion Toolbox) to model local diffusion and changes in tractography at baseline and three months between the intervention and control arms. Changes in diffusion imply micro-structural (axonal) connectivity and represent structural brain change.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

14. Secondary Outcome

Title	Quantitative Magnetisation Transfer Structural Changes on fMRI (Functional Magnetic Resonance Imaging)
Description	Quantitative magnetisation transfer imaging estimates liquid and semisolid (macromolecular) constituents of tissue at baseline and three months between the intervention and control arms. Changes in macromolecular content imply micro-structural (myelin) connectivity and represent structural brain change.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

15. Secondary Outcome

Title	Feasibility of Additional Simulation Training
Description	Qualitative survey of participants opinions of the addition of simulation to their usual clinical training programme
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

Data were not collected

Arm/Group Title	Simulation Training	Non-simulation/Routine Training
Arm/Group Description	Addition of simulation training during usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme Simulation training: Simulation training in a skills lab for 1 hour per week over 13 weeks on dry, bench-top box trainers and anatomical simulators	Usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme
Measure Participants	0	0

Adverse Events

Time Frame	12 weeks (study period)
Arm/Group Title	Simulation Training		Non-simulation/Routine Training
Arm/Group Description	Addition of simulation training during usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme Simulation training: Simulation training in a skills lab for 1 hour per week over 13 weeks on dry, bench-top box trainers and anatomical simulators		Usual clinical training as part of a GMC (General Medical Council) recognised Deanery training programme
All Cause Mortality
	Simulation Training		Non-simulation/Routine Training
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)
Serious Adverse Events
	Simulation Training		Non-simulation/Routine Training
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Simulation Training		Non-simulation/Routine Training
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)

Limitations/Caveats

Some outcomes were not analysed as stated in the trial protocol as during the construct validation stage these were found to not correlate with performance

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.