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Validated!
                                                                                                      Proven wiith FLS
                                                                                                       Proven w th FLS
                                                                                                       Better than VR
                                                                                                        Better than VR
                                                                                                     Preferred by users
                                                                                                     Preferred by users

                                                                                  ProMIS and FLS
                                                                                  •   ProMIS metrics are “excellent predictors of scores
                                                                                      in the standard FLS simulator” and “predict
                                                                                      readiness for FLS Certification”1 2 3

                                                                                  •   ProMIS metrics are valid on peg transfer, pre-tied
                                                                                      loop placement and knot-tying tasks4

                                                                                  •   “Initial trials of the metrics on the FLS Precision-
                                                                                      Cutting Task show that ProMIS is as accurate as
                                                                                                              5
                                                                                      the current method”
ProMIS assesses performance on               Augmented Reality combines VR
real models where real haptics               with a physical model allowing       •   FLS tasks are transferable to the ProMIS simulator
are important, eg in Suturing and            virtual bleeding and real haptics.
Knot-tying                                                                            with traditional FLS scoring and intrinsic ProMIS
                                                                                      metrics being good measurement tools. A ProMIS
                                                                                      total path length <4000 mm or total smoothness
                                                                                                                                   25
                                                                                      <6000 reliably predicts a passing FLS score.

                                                                                  ProMIS vs pure VR
                                                                                  •   ProMIS out-performed the virtual reality
                                                                                                24
                                                                                      simulators

    ProMIS has pure VR Modules, eg          Vision technology enables             •   Scores for ProMIS were significantly higher than
    for Instrument Handling. Users          tracking of errors and automatic
    still use real instruments.             calculation of dissected tissue.
                                                                                      for SurgicalSIM for overall realism, thread
                                                                                      behavior, reflection of clinical ability, and overall
                                                                                      educational value.6

                                                                                  •   In comparison with LapSim, ProMIS was regarded
                                                                                      by all participants as a better simulator for
                                                                                      laparoscopic skills training on all tested features7

    ProMIS surgical simulator                                                     •   “Only [ProMIS] was able to distinguish between
                                                                                      advanced trainees and beginners (and) was
    ProMIS Modules range from Basic Laparoscopic Skills to                            graded more realistic (70% vs 33%) and more
    MIS procedures like LapColectomy. For more information                            useful (83% vs 62%)” than Xitact8
    on ProMIS, please contact us at:
                                                                                  •   The ability of performance metrics of [ProMIS] to
    Email: promis@haptica.com
                                                                                      discern predicted performance differences
    U.S. tel: +1 617 342 7270
                                                                                      between experts and non-experts was better
    RoW tel: +353 (0)1 676 7310
                                                                                      than for SimSurgery’s robotic surgery simulator and
1
    SAGES 2006 S064 Ritter et al,
                                                                                      SurgicalSIM 9
2
    SAGES 2006 P237 McCluney MD, et al,
3

4
    SAGES 2007 P279 McCluney et al,                                               ProMIS: the preferred Simulator
    SAGES 2006 S065 Vuong et al,
5
    SAGES 2007 ETP057 Young et al,                                                •   ProMIS can be used effectively with the DaVinci
6
    SAGES 2006 P224 Fellinger, et al,
7
                                                                                      robot to obtain performance data with robotic
    World J Surg. 2007 Apr;31(4):764-72. Botden et al,
8
    SAGES 2007 P270 Hahnloser et al,                                                  instrumentation10
9
    SAGES 2007 S077 Lin et al,
10
     SAGES 2006 Narula et al,                                                     •   Residents believe that ProMIS is easy to use and
11

24
     SAGES 2006 P219 Chang et al,                                                     improved their operative skills11
     Heinrichs, et al 2007
25
     Hungness, et al 2008
Validation
1.    SAGES 2006 Scientific Session S064                                         2.     SAGES 2006 Education/Outcomes–P237
CONCURRENT VALIDITY OF AUGMENTED REALITY METRICS                                 VALIDATION OF THE PROMIS HYBRID SIMULATOR USING
APPLIED TO THE FUNDAMENTALS OF LAPAROSCOPIC                                      A STANDARD SET OF LAPAROSCOPIC TASKS
SURGERY (FLS)                                                                    A L McCluney MD, L S Feldman MD, G M Fried, Steinberg-
E. Matt Ritter MD, Tamara W Kindelan MD, Curtis Michael,                         Bernstein Centre for Minimally Invasive Surgery, McGill
Elisabeth A Pimentel BA, Mark W Bowyer MD, 1NCA Medical                          University Health Centre, Montreal, QC, Canada
Simulation Center, Department of Surgery, Uniformed Services
                                                                                 Introduction
University, 2Division of General Surgery, National Naval Medical
Center, Bethesda Maryland                                                        SAGES Fundamentals of Laparoscopic Surgery (FLS) tasks are
                                                                                 validated measures of technical skills, however FLS scoring
Objective
                                                                                 requires a trained proctor. The ProMIS simulator (Haptica;
Current skills assessment in the Fundamentals of Laparoscopic                    Dublin, IR) is a ‘hybrid’ system with physical and virtual
Surgery (FLS) program is labor intensive requiring one proctor for               reality tasks. It has the flexibility to incorporate any
every 1-2 subjects. The ProMIS Augmented Reality (AR) simulator                  physical task and score it with ProMIS metrics. Metrics are
(Haptica, Dublin IRE) allows for objective assessment of physical                automated and report motion analysis data as instrument
tasks through instrument tracking technology. We hypothesized                    path length (PL) and instrument smoothness (IS). The
that the ProMIS metrics could differentiate between ability                      purpose of this study was to test for construct and
groups as well as standard FLS scoring with fewer personnel                      concurrent validity using FLS tasks in the ProMIS simulator.
requirements.
                                                                                 Methods
Methods
                                                                                 5 laparoscopic novices and 5 experts performed FLS tasks in
We recruited 60 volunteer subjects. Subjects were stratified                     both the standard FLS simulator box and the ProMIS
based on their laparoscopic surgical experience. Those who had                   simulator. Assessments were made based on FLS metrics, as
performed more than 100 laparoscopic procedures were                             well as PL and IS. Student’s t-test was used to compare the
considered experienced (n=8). Those with less than 10                            mean (SD) of total scores for novices and experts. Pearson’s
laparoscopic procedure were considered novices (n=44). The rest                  correlations were calculated for standard FLS scores in
were intermediates (n=8). All subjects performed up to 5 trials                  relation to ProMIS FLS scores, total PL, and total IS.
of the peg transfer task from FLS in the ProMIS simulator. FLS                   Significance was defined as p < 0.01 (*).
score, instrument path length, and instrument smoothness
                                                                                 Results
assessment were generated for each trial.
                                                                                 Standard FLS scores correlated strongly with ProMIS FLS
Results
                                                                                 scores (r=0.90), total PL (r=-0.83), and total IS (r=-0.78)
For each of the 5 trials, experienced surgeons outperformed                      (p&lt; 0.01).
intermediates who in turn out performed novices. Statistically
                                                                                 Conclusions
significant differences were seen between the groups across all
trials for FLS score (p < 0.001), ProMIS path length (p <0.001) and               FLS tasks performed in ProMIS, when scored by either
ProMIS smoothness (p < 0.001). When the FLS score was                            traditional FLS metrics or by intrinsic ProMIS metrics,
compared to the path length and smoothness metrics, a strong                     discriminate effectively between novices and experts. Based
relationship between the scores was apparent for novices (r =                    on the observed correlations, ProMIS FLS scores, total PL,
0.78, r = 0.94 , p < 0.001) respectively), intermediates (r = 0.5, p             and total IS are excellent predictors of scores in the
= 0.2 , r = 0.98, p < 0.001), and experienced surgeons (r = 0.86, p              standard FLS simulator.
= 0.006, r = 0.99, p < 0.001)

Conclusions

The construct that the standard scoring of the FLS peg transfer
task can discriminate between experienced, intermediate, and
novice surgeons is validated. The same construct is valid when
the task is assessed using the metrics of the ProMIS. The high
correlation between these scores establishes the concurrent
validity of the ProMIS metrics. The use of AR for objective
assessment of FLS tasks could reduce the personnel requirements
of assessing these skills while maintaining the objectivity.




                       www.haptica.com | email: promis@haptica.com | tel (NAm) +617 342 7270 | tel (RoW) +353 (0) 1 676 7310
Validation
3.    SAGES 2007 Education/Outcomes – P279                                       4.     SAGES 2006 Scientific Sessions S065
AUTOMATED PROMIS SIMULATOR METRICS PREDICT                                       WHAT CAN MOTION DERIVATIVES TELL US ABOUT SKILL
READINESS FOR FLS CERTIFICATION                                                  PERFORMANCE?
Anthony L McCluney MD, J Cao, G N Polyhronopoulos MD, D D                        Laurel N Vuong BS, Steven D Schwaitzberg MD, Caroline G
Stanbridge, L S Feldman MD, G M Fried MD, Steinberg-Bernstein                    Cao PhD, Tufts University School of Medicine, Cambridge
Centre for Minimally Invasive Surgery, McGill University,                        Health Alliance, Tufts University School of Engineering
Montreal, QC, Canada
                                                                                 Surgical simulators are a popular topic of discussion on
Introduction                                                                     training in laparoscopic surgery. They reduce the need to
                                                                                 use human cadavers or animal models for skills
SAGES Fundamentals of Laparoscopic Surgery (FLS) tasks are
                                                                                 development. A subset of the MISTELS methodology has
validated measures of technical skills. Certification requires
                                                                                 been employed in the manual skills assessment for the
travel to a testing site and a fee, thus a reliable method of
                                                                                 Fundamentals Laparoscopic Skills (FLS) program because it
predicting readiness for the exam would be advantageous. The
                                                                                 was shown to be a valid discriminator of surgical
ProMIS simulator (Haptica) provides automated scoring. FLS tasks
                                                                                 experience. Pure performance outcome, such as time to
can be placed in the ProMIS simulator and scored using time
                                                                                 task completion and number of errors, is used for scoring,
(TT), as well as motion analysis metrics: instrument path length
                                                                                 which is dependent on the consistency of the scorer. A new
(PL) and instrument smoothness (IS). This study was designed to
                                                                                 simulator environment has been created which uses motion
evaluate these automated ProMIS metrics and their ability to
                                                                                 tracking for measurement of performance outcome
predict readiness for FLS certification.
                                                                                 measures and motion derivatives such as smoothness and
Methods                                                                          efficiency.

33 subjects (12 students, 16 residents PGY 1-4, and 5 experts)                   The purpose of the study was to determine if the motion
performed FLS tasks in the standard simulator and in ProMIS.                     derivatives can be used to automatically and objectively
Tasks were scored by FLS and ProMIS metrics. For each ProMIS                     discriminate experience levels. Twenty-one subjects (6
metric, the total score was calculated by summing the scores for                 medical students, 14 surgical residents, and 1 expert
the 5 FLS tasks. Pearson’s correlations were calculated for                      surgeon) were recruited to perform the following tasks: peg
ProMIS metrics versus standard FLS scores. Multivariate                          transfer, pattern cutting, pre-tied loop placement,
regression analysis identified independent predictors of standard                extracorporeal and intracorporeal knot-tying in the new
FLS performance. These variables were then used for sensitivity                  simulator environment. Subjects were evaluated on time to
and specificity calculations in order to establish a ProMIS pass-                completion, errors, smoothness and total path length (used
fail score for predicting readiness for FLS certification.                       to calculate efficiency).
Significance was defined as p<0.05.                                              Results show that experience level is still distinguishable
                                                                                 when using task-dependent parameters to evaluate
Results
                                                                                 performances during peg transfer (p= 0.035), pre-tied loop
TT (r= -0.82), PL (r= -0.56), and IS (r= -0.75) all correlated                   placement (p= 0.022), extracorporeal (p= 0.0006) and
significantly with standard FLS score. Multivariate regression                   intracorporeal (p= 0.025) knot tying in this new simulator
analysis identified TT as the strongest predictor of FLS score. A                environment.
TT score of 1000 maximizes sensitivity and specificity and was
                                                                                 Evaluation of performance using task-independent
identified as the pass-fail for reliably predicting FLS
                                                                                 parameters significantly distinguished training level in three
performance.
                                                                                 tasks: (1) smoothness of the left instrument was significant
Conclusions                                                                      as a function of experience level in extracorporeal knot-
                                                                                 tying (p= 0.016), (2) efficiency (total path length divided by
Automated ProMIS metrics correlate well with standard FLS
                                                                                 time to completion) was also significant in the movement of
performance. In this study sample, a TT score less than 1000
                                                                                 the right tool as a function of experience level in peg
reliably predicted a passing FLS certification score.
                                                                                 transfer (p= 0.0011) and (3) pre-tied loop placement (p=
                                                                                 0.013979).

                                                                                 This preliminary analysis shows that automatic and
                                                                                 objectively measured motion derivatives can be associated
                                                                                 with the level of experience. These results indicate a
                                                                                 potential for the application of an automatic and objective
                                                                                 means of skills evaluation.




                       www.haptica.com | email: promis@haptica.com | tel (NAm) +617 342 7270 | tel (RoW) +353 (0) 1 676 7310
Validation
5.   SAGES 2007 ETP057                                                           6.     SAGES 2006 Education/Outcomes–P224
OBJECTIVE MEASUREMENT OF FLS PRECISION CUTTING TASK                              COMPLEX LAPAROSCOPIC TASK PERFORMANCE ON TWO
Derek Young, Fiona Slevin, Derek Cassidy, Donncha Ryan, Haptica                  NEW COMPUTER-BASED SKILLS TRAINING DEVICES
Inc                                                                              Erika K Fellinger MD, Michael E Ganey MD, Anthony G
                                                                                 Gallagher PhD, Daniel J Scott MD, Ron W Bush BS, Neal E
The Precision-Cutting Task in the SAGES/ACS FLS Program
                                                                                 Seymour MD, Department of Surgery, Baystate Medical
requires the user to dissect a circle of specific size and shape
                                                                                 Center, Springfield, MA
from a marked piece of mesh. Currently, measurement of the
accuracy and area dissected is done by observation and by                        Introduction
measuring the dissected mesh on a measurement grid. Using
                                                                                 New computer-based skills training devices can simulate and
advanced vision-tracking, the ProMIS surgical simulator takes an
                                                                                 measure performance of complex surgical tasks. The aim of
image of the dissected mesh and automatically generates a
                                                                                 this study is to determine basic face and construct validity
metric, indicating the accuracy of the shape and area dissected.
                                                                                 characteristics of two new devices configured for
Method                                                                           laparoscopic suturing and knot-tying tasks.

1. Once the user has completed the Precision-Cutting Task,                       Methods
ProMIS takes an image of the dissected mesh. The image is
                                                                                 At the 2005 SAGES meeting, Learning Center attendees
converted to binary image and then scanned using a blob
                                                                                 evaluated two computer-based skills training platforms:
detection algorithm which produces a list of blobs.
                                                                                 SurgicalSIM (SS), a virtual reality (VR) device (METI,
2. The blob with the largest area is taken as the cut out area and               Sarasota, FL; SimSurgery, Oslo, Norway) and ProMIS (PM), a
the number of pixels are counted inside this area.                               computer-enhanced video trainer (Haptica, Ltd., Dublin,
                                                                                 Ireland). Demographic and training data were collected
3. The actual measurement for area is given in cm2. This is
                                                                                 from 73 subjects. All were asked to perform 2 iterations of
calculated by counting the number of pixels in a known area of
                                                                                 laparoscopic suturing and intracorporeal knot-tying (10-
the image and then using ratios to determine the area of the cut
                                                                                 minute time limit) on each device. A 6-question survey was
out. (Note: this calibration step is achieved by taking the tissue
                                                                                 used to define impressions of task realism, relevance, and
off the tray and running the blob detection and pixel count on
                                                                                 execution using a 5-point Likert scale. Performance data
the uncovered black foam of which the exact area is known)
                                                                                 (SS: time, path length, errors; PM: time, path length,
Results                                                                          smoothness) were collected on both devices and
                                                                                 comparisons made between user-defined expert and
Initial trials of the metrics on the FLS Precision- Cutting Task
                                                                                 nonexpert (intermediate and novice) groups (ANOVA and
show that ProMIS is as accurate — and frequently more accurate
                                                                                 Mann Whitney U test).
— than the current human observation method.
                                                                                 Results

                                                                                 46 subjects used SS and 56 used PM. Task completion rate
                                                                                 was 80% for SS and 93% for PM. Experts performed better
                                                                                 than nonexperts for all performance measures on SS
                                                                                 (composite score 496±41 vs 699±60, p < 0.005) and PM
                                                                                 (974±111 vs 1466±89, p < 0.005). Post-task survey scores for
                                                                                 PM were significantly higher for perceived realism (overall
                                                                                 realism and thread behavior), reflection of clinical ability,
                                                                                 and overall educational value. Perception of educational
                                                                                 value was not significantly different between the devices
                                                                                 among subjects with prior VR experience.

                                                                                 Conclusions

                                                                                 Using subject-defined expert and nonexpert groups,
                                                                                 construct validity was demonstrated for all performance
                                                                                 measures on both training devices. Surveyed face validity
                                                                                 measures favored the non-VR device, but results also
                                                                                 suggest that subjects with prior VR training experience are
                                                                                 more apt to accept a new VR surgical training platform.




                       www.haptica.com | email: promis@haptica.com | tel (NAm) +617 342 7270 | tel (RoW) +353 (0) 1 676 7310
Validation
7.   World J Surg. 2007 Apr;31(4):764-72.                                        8.     SAGES 2007 Education/Outcomes – P270
AUGMENTED VERSUS VIRTUAL REALITY LAPAROSCOPIC                                    COMPARISON AND VALIDATION OF TWO DIFFERENT
SIMULATION: WHAT IS THE DIFFERENCE? : A COMPARISON                               SURGICAL SKILLS SIMULATORS
OF THE PROMIS AUGMENTED REALITY LAPAROSCOPIC                                     Dieter Hahnloser MD,Rachel Rosenthal MD,Christian
SIMULATOR VERSUS LAPSIM VIRTUAL REALITY                                          Hammel,Daniel Oertli,Markus Müller,Pierre-Alain Clavien,
LAPAROSCOPIC SIMULATOR.                                                          Department of Visceral and Transplantation Surgery,
Botden SM, Buzink SN, Schijven MP, Jakimowicz JJ. Catharina                      University Hospital Zurich, Switzerland
Hospital, Eindhoven, The Netherlands.
                                                                                 Background
Background
                                                                                 Simulators are increasingly incorporated in surgical training
Virtual reality (VR) is an emerging new modality for laparoscopic                and validation is important. The simulations need to
skills training; however, most simulators lack realistic haptic                  resemble the task they are based upon (face validity) and
feedback. Augmented reality (AR) is a new laparoscopic                           the simulator should be able to differentiate between levels
simulation system offering a combination of physical objects and                 of experience (construct validity).
VR simulation. Laparoscopic instruments are used within an
                                                                                 Aim
hybrid mannequin on tissue or objects while using video tracking.
This study was designed to assess the difference in realism,                     To assess two different types of computer-based simulators:
haptic feedback, and didactic value between AR and VR                            the fully computerised virtual reality (VR) simulator Xitact
laparoscopic simulation.                                                         LS500 (VR-simulator) and the hybrid ProMisTM simulator.
                                                                                 Methods: 146 participants (61%) of the 22nd Davos
Methods
                                                                                 International Gastrointestinal Surgery Workshop performed
The ProMIS AR and LapSim VR simulators were used in this study.                  on a voluntary basis three similar exercises (camera
The participants performed a basic skills task and a suturing task               navigation, clip and cut, and dissection) on the two
on both simulators, after which they filled out a questionnaire                  different simulators. Objective performance parameters
about their demographics and their opinion of both simulators                    recorded by either simulator and subjective evaluation by
scored on a 5-point Likert scale. The participants were allotted                 questionnaire were compared between beginner (n=73) and
to 3 groups depending on their experience: experts,                              advanced participants (n=73).
intermediates and novices. Significant differences were
                                                                                 Results
calculated with the paired t-test.
                                                                                 The camera navigation exercise was completed by 52% of
Results
                                                                                 the participants on the VR- and by 47% on the hybrid
There was general consensus in all groups that the ProMIS AR                     simulator with no difference in performance parameters
laparoscopic simulator is more realistic than the LapSim VR                      between beginners and advanced trainees. The hybrid
laparoscopic simulator in both the basic skills task (mean 4.22                  simulator was graded more realistic (70% vs. 20%, p=.001)
resp. 2.18, P < 0.000) as well as the suturing task (mean 4.15                   and more useful (65% vs. 36%, p=.043) than the VR-
resp. 1.85, P < 0.000). The ProMIS is regarded as having better                  simulator. Participation was higher at the clip and cut
haptic feedback (mean 3.92 resp. 1.92, P < 0.000) and as being                   exercise (75% VR- and. 52% hybrid simulator) and advanced
more useful for training surgical residents (mean 4.51 resp. 2.94,               trainees performed significantly better (shorter tool-tip-
P < 0.000).                                                                      travel distance, smoother, quicker and with higher score) on
                                                                                 both simulators compared to beginners. The clip and cut
Conclusions
                                                                                 exercise was graded more realistic on the hybrid (81% vs.
In comparison with the VR simulator, the AR laparoscopic                         44%, p=.007) and similar useful on both simulators (77% vs.
simulator was regarded by all participants as a better simulator                 72%). The dissection exercise was completed more often on
for laparoscopic skills training on all tested features.                         the hybrid simulator (47% vs. 23%, p=0.002). Only the hybrid
                                                                                 simulator was able to distinguish between advanced
                                                                                 trainees and beginners, with significantly higher scores for
                                                                                 all performance parameters for the latter. The hybrid
                                                                                 simulator was graded more realistic (70% vs. 33%, p=.016)
                                                                                 and more useful (83% vs. 62%, p=.12). Overall, acceptance
                                                                                 of requirement to train on and to be evaluated by such
                                                                                 simulators is still low (53% and 50%, respectively).

                                                                                 Conclusion

                                                                                 Fully computerized VR- or hybrid simulator performance
                                                                                 parameters can distinguish between beginner and advanced
                                                                                 trainees for perceptual motor skills (proving construct

                       www.haptica.com | email: promis@haptica.com | tel (NAm) +617 342 7270 | tel (RoW) +353 (0) 1 676 7310
Validation
validity), but not for visuo-spatial exercises such as the camera                    __________________________________________
navigation.
                                                                                     10.
__________________________________________                                           11. SAGES 2006 Scientific Sessions S096
                                                                                     A COMPUTERIZED ANALYSIS OF ROBOTIC VERSUS
                                                                                     LAPAROSCOPIC TASK PERFORMANCE
9.     SAGES 2007: S077
                                                                                     V K Narula MD, W C Watson MD, S S Davis MD, K Hinshaw BS,
COMPUTER-BASED LAPAROSCOPIC AND ROBOTIC SURGICAL
                                                                                     B J Needleman MD, D J Mikami MD, J W Hazey MD, J H
SIMULATORS: PERFORMANCE CHARACTERISTICS AND
                                                                                     Winston MD, P Muscarella MD, M Rubin, V Patel MD, W S
PERCEPTIONS OF NEW USERS
                                                                                     Melvin MD, The Ohio State University. CMIS. Columbus, OH
David W Lin MD, John R Romanelli MD, Renee E Thompson
MD,Michael E Ganey MD, Ron W Bush BS, Neal E Seymour MD,                             Introduction
Baystate Medical Center, Department of Surgery                                       Robotic technology has been postulated to improve
The expanding inventory of advanced surgical training devices                        performance in advanced surgical skills. We utilized a novel
now includes simulators for laparoscopic and robotic surgery. In                     computerized assessment system to objectively describe the
order to define perceptions of the need and value of such                            technical enhancement in task performance comparing
devices, we evaluated the initial experience of surgeons using                       robotic and laparoscopic instrumentation.
both in the course of performance of an advanced laparoscopic
                                                                                     Methods and Procedures
skill.
                                                                                     Advanced laparoscopic surgeons (2- 10 yrs experience)
Methods                                                                              performed 3 unique task modules using laparoscopic and
At the 2006 SAGES meeting, 62 Learning Center attendees evaluated a                  Telerobotic Surgical Instrumentation (Intuitive Surgical,
new virtual reality (VR) robotic surgery simulator (RS) [SimSurgery, Oslo,           Sunnyvale, CA). Performance was evaluated using a
Norway] as well as either a computer-enhanced laparoscopic [ProMIS                   computerized assessment system (ProMIS, Dublin, Ireland)
(PM), Haptica, Ltd, Dublin, Ireland] or a VR simulator [SurgicalSIM (SS),            and results were recorded as time (sec), total path (mm)
SimSurgery and METI, Inc, Sarasota, FL]. Demographic and training data               and precision. Each surgeon had an initial training session
were collected and all were assessed during one iteration of                         followed by two testing sessions for each module. A Paired
laparoscopic suturing and knot-tying on RS and either PM or SS. An 8-                Student’s T-Test was used to analyze the data.
question survey was used to determine users? impressions of task
                                                                                     Results
realism, interface quality, and educational value (5-point Likert scale).
Performance data [time, path length, smoothness (PM), errors (SS/RS)]                10 surgeons completed the study. Objective assessment of
were collected and comparisons made between user-defined groups and                  the data is presented in the table below. 8/10 surgeons had
different simulation platforms (Mann-Whitney Test, ANOVA).                           significant technical enhancement utilizing robotic
                                                                                     technology Laparoscopic vs Robotic Time (sec) Total
Results                                                                              Path(mm) Precision Module 1210 vs 161 # 11649 vs 5571 *
Task completion rate was greater for experts than nonexperts on all                  1434 vs 933 * Module 2119 vs 68 * 5573 vs 1949 * 853 vs 406 *
platforms (PM 100% vs 75%; SS 100% vs 36%; RS 93% vs 36%). Experts                   Module 377 vs 55 * 4488 vs 2390 * 552 vs 358 * # = p < 0.009 *
performed better than nonexperts on all performance measures on PM                   = p<0.001 Conclusions: The ProMIS computerized assessment
(p<0.05: time 154±16 vs 205±12; path length 820±97 vs 1287±97;                       system can be modified to objectively obtain task
smoothness 952±111 vs 1582±127). There were no significant differences               performance data with robotic instrumentation. All the
between experts and nonexperts for SS and RS performance measures.                   tasks were performed faster and with more precision using
Perception of value of haptic features was less for subjects with prior robot        the robotic technology than standard laparoscopy.
experience (n=10; p<0.05). Otherwise realism, interface quality, and
educational value scores did not differ on the basis of prior simulator or
robot use. Nonexperts found that robotic simulation better reflected
clinical skill than did experts. Overall, subjective quality was scored higher
for PM than for SS or RS.

Conclusions

The ability of performance metrics of the computer-enhanced simulator
to discern predicted performance differences between experts and
nonexperts was better than for VR devices with a single task iteration.
Initial use of VR devices was associated with a lower overall perception
of realism and educational value as compared to use of physical objects
in the non-VR simulator. This may reflect the need for familiarization
with the computer-generated environment before the educational
potential of VR can be realized.
                           www.haptica.com | email: promis@haptica.com | tel (NAm) +617 342 7270 | tel (RoW) +353 (0) 1 676 7310
Validation
12. SAGES 2006 Education/Outcomes–P219                                           13.    SAGES 2007: S080
INTEGRATING SIMULATION LAB TRAINING INTO A SURGICAL                              THE IMPACT OF KNOWLEDGE OF RESULTS IN SURGICAL
RESIDENCY PROGRAM: IS VOLUNTARY PARTICIPATION                                    SKILLS TRAINING
EFFECTIVE                                                                        A. O’Connor MD, C. Cao PhD, S. Schwaitzberg MD,
Lily Chang MD, James Petros MD, Donald Hess MD, Caroline                         Department of Mechanical Engineering, Tufts University.
Rotondi BA, Timothy Babineau MD, Boston Medical Center
                                                                                 Background
Objective
                                                                                 Concerns about the adequacy of advanced laparoscopic
Surgical training programs nationwide are struggling with the                    training continue to be raised despite a proliferation of
integration of simulation training into their curriculum given the               training systems exist. The manner in which the training
constraints of the 80-hour work week. We examine the                             modules are structured to maximize learning has not been
effectiveness of voluntary training in a simulation lab as part of               examined. There are many aspects to the accumulation of
the surgical curriculum. Methods: The ProMIS simulator was                       laparoscopic skills during training, one of which is
introduced into the general surgery residency at Boston                          Knowledge of Results (KR), i.e. the information provided to
University Medical Center. All categorical residents (28) were                   individuals about the outcomes of their motor responses in
required to attend a 2-hour training session and curriculum                      their environment. We studied the effects of KR on the
review. Non-categorical residents (23) were given the option to                  learning curve of laparoscopic suturing and knot tying.
complete training. After the introductory session, time spent in
                                                                                 Aims
the lab was encouraged, but voluntary. Use of the simulator was
tracked for all residents. Participation in the simulation                       We evaluated the learning curves of 9 medical students with
curriculum was defined as 3 or more uses of the simulator. After                 no previous laparoscopic surgical experience under three
3 months, all residents completed a survey regarding the                         different conditions, each with different levels of
simulation lab and their simulator usage. Results: 26 (93%)                      knowledge of results.
categorical residents and 3 (6%) non-categorical residents
completed the introductory simulator training session. Over a 3                  Methods
month period, use of the simulator at least once was 31% among                   Subjects were randomly assigned to one of three groups.
all eligible residents; 80% of PGY1, 40% of PGY2, 60% of PGY3,                   Each subject attended a training session for 1 hour each
and 0% of PGY4 and PGY5. Four residents (14%) participated in                    day, 6 days a week for 4 weeks. Group 1 (No feedback)
the simulation curriculum. 71% of simulator usage was during                     received no knowledge of results (KR) and no performance
working hours while 29% was completed post-call or off duty.                     feedback. Group 2 (feedback only) received factual KR
Most residents agreed that the simulator was easy to use and                     following each training session, but no coaching. Group 3
improved their operative skills, but did not think it was a good                 (feedback and coaching) received KR and coaching. Learning
substitute for actual operative experience. Reported reasons for                 curves were plotted based on task time, smoothness of
not using the simulator included off-site rotation (44%), no time                instruments and instrument’s path length. The task used
(30%), and no interest (11%).                                                    was an intracorporeal suture/knot tying in the ProMIS
                                                                                 laparoscopic simulator. Perceived workload for each session
Conclusions
                                                                                 was recorded using a standardized NASA TLX workload
Voluntary use of a surgical simulation lab leads to minimal                      score.
participation in a training curriculum. Participation should be
mandatory if it is to be an effective part of a residency                        Results
curriculum.                                                                      The variability across each session for each student was
                                                                                 calculated for each of the three parameters. There was
                                                                                 statistical significance between the groups for all
                                                                                 parameters (p-values 0.0002, 0.0002 and 0.009). Significant
                                                                                 differences were found between groups 2 and 3 and group 1
                                                                                 (p values 0.0314-0.0410) Groups 2 and 3 learned
                                                                                 significantly faster than those in Group 1, reaching
                                                                                 performance plateaus at earlier sessions. There were no
                                                                                 significant differences between groups 2 and 3 (p-values
                                                                                 0.1211, 0.1758 and 0.1375). Providing individuals with
                                                                                 knowledge of results lowered their perceived workload,
                                                                                 adding instructional feedback lowered this even further.
                                                                                 These results demonstrate that KR is essential for efficient
                                                                                 surgical skill acquisition. Individual coaching, a labor
                                                                                 intensive proposition, reduces workload but has NO added
                                                                                 beneficial effect on the speed of learning. These results

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Validation
provide a useful basis for developing efficient and cost effective               15. SAGES 2007 Education/Outcomes – P284
surgical skills training curriculum.                                             ABSTRACT VIRTUAL REALITY TRAINING DEVELOPS CORE
____________________________________________________
                                                                                 LAPAROSCOPIC SKILLS COMPARABLE TO EXPERIENCED
                                                                                 LAPAROSCOPIC SURGEONS: RESULTS OF A PROSPECTIVE
14. SAGES 2007: Education/Outcomes – P267                                        RANDOMIZED TRIAL COMPARING TWO VIRTUAL REALITY
THE CONSTRUCT VALIDITY OF COMPUTER-DERIVED                                       TRAINERS
PERFORMANCE METRICS FOR SELECTED SIMULATED
                                                                                 E. Matt Ritter MD, Elisabeth A Pimentel BA, Ryan E Earnest
LAPAROSCOPIC TASKS
                                                                                 BS, Randy S Haluck MD, Mark W Bowyer MD, National Capital
J. A Oostema MD, Matthew Abdel BS, Jon C Gould MD, University                    Area Medical Simulation Center, Uniformed Services
of Wisconsin School of Medicine and Public Health, Department                    University, Bethesda, Maryland / Department of Surgery,
of Surgery                                                                       Pennsylvania State College of Medicine, Hershey,
                                                                                 Pennsylvania
Introduction

A surgical skills assessment tool is said to demonstrate evidence                Introduction
of construct validity if users with more experience, and by                      While simulation is becoming more widely accepted in
inference more skill, perform better or more efficiently.                        surgical training, comparative trials on the training
Computer derived motion metrics such as smoothness (the                          effectiveness of these simulators are lacking. We sought to
number of times an instrument tip changes velocity during a                      compare the effectiveness of two abstract virtual reality
task) and path length may be more sensitive measures of skill for                trainers to train laparoscopic skills as assessed by the
a particular task than traditional metrics such as time.                         Fundamentals of Laparoscopic Surgery (FLS). We then
                                                                                 compared the post training performance of the novice
Methods
                                                                                 subjects with a group of experienced surgeons.
Twenty-four medical students (third year), 19 surgical residents
(PG1-5), and 3 attending surgeons were asked to perform four                     Methods and Results
different tasks 3 times in a hybrid computer-based physical                      20 novice medical students were recruited. Each subject
laparoscopic trainer (ProMIS, Haptica Inc., Dublin). The 4 tasks in              performed a pre-test consisting of 3 FLS tasks - Peg Transfer
order of complexity were laparoscopic orientation (Task 1),                      (PT), Pattern Cut (PC) and Intracorporeal Suture (IS) -
object positioning (Task 2), sharp dissection (Task 3), and intra-               placed in the ProMIS augmented reality simulator (Haptica,
corporeal knot tying (Task 4). Metrics recorded were time, path                  Ireland). They were then randomized to train to
length, and smoothness. Laparoscopic operative experience for                    predetermined levels of proficiency on 3 tasks of the
each user was quantified using case logs. Correlations were                      Minimally Invasive Surgical Trainer-Virtual Reality (MIST-VR)
determined using regression analysis and ANOVA.                                  (Mentice, Sweden) or the Rapid Fire/Smart Tutor (RFST)
                                                                                 (Verefi, Elizabethtown, PA). After reaching the proficiency
Results
                                                                                 levels, both groups then took a post test consisting of 3
A statistically significant correlation was observed between                     trials of the same tasks used for the pre-test. Post test
experience and performance for all three metrics for tasks 2-4                   performance by both groups was then compared to a control
(all p< 0.01). Smoothness was the only metric to correlate in the                group, composed of 10 experienced surgeons who had
laparoscopic orientation task. Within tasks, time and smoothness                 completed the same post test.
correlate much more strongly with experience and to a similar
                                                                                 MIST-VR and RFST groups demonstrated statistically
degree. The strongest correlation was observed for the knot
                                                                                 significant improvement from the pre-test to the post test
tying task (r2=0.60 for time and 0.59 smoothness). An r2=1.0
                                                                                 on all 3 FLS tasks (p < 0.0001). There was no significant
would represent a perfect correlation between experience and
                                                                                 difference in post test performance between the MIST-VR
the specified metric.
                                                                                 and RFST groups. When the simulation trained groups were
Conclusions                                                                      compared to experienced controls there was no significant
                                                                                 difference in performance with respect to PT. The
The computer-derived metrics measured by the hybrid trainer
                                                                                 experienced controls did significantly outperformed the
correlate with laparoscopic experience. Further study is
                                                                                 MIST-VR group in PC (p<0.01) and IS (p<0.05), but
necessary to determine if specific metrics are better indicators
                                                                                 differences between the experienced controls and the RFST
of actual skill.
                                                                                 group did not reach statistical significance.

                                                                                 Conclusion

                                                                                 Simulation based training on either the MISTVR or the RFST
                                                                                 simulator improves the skill level of novices as assessed by
                                                                                 FLS. The post training skill level of these novices compares
                                                                                 favorably with a group of experienced surgeons. Virtual
                                                                                 Reality trainers, such as RFST and MISTVR, train

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Validation
fundamental laparoscopic skills equally and to a level                           17. SAGES 2006 Emerging Technologies P036
comparable to a group of experienced practicing surgeons.                        AUGMENTED REALITY SIMULATOR FOR HAND-ASSISTED
____________________________________________________
                                                                                 LAPAROSCOPIC COLECTOMY
                                                                                 Derek Young, Derek Cassidy, Fiona Slevin, Donncha Ryan,
                                                                                 Haptica Ltd, Dublin, Ireland.
16. SAGES07 Ergonomics/Instrumentation P307
                                                                                 Training in Hand-Assisted Laparoscopic Colectomy (HALC)
A COMPUTERIZED ANALYSIS OF STANDARD VERSUS HIGH
                                                                                 has largely been done using cadavers and porcine models.
DEXTERITY LAPAROSCOPIC INSTRUMENTATION IN TASK
                                                                                 These have drawbacks in terms of realism, logistics and lack
PERFORMANCE
                                                                                 of performance measurement. A Simulator would provide
V K Narula MD,K M Reavis MD,D R Renton MD,D J Mikami MD,B J                      consistent instruction and practice and provide feedback on
Needleman MD,J W Hazey MD,K E Hinshaw BS,W S Melvin MD,                          performance. However, given the range of instruments used
THE OHIO STATE UNIVERSITY HOSPITAL, CENTER FOR MINIMALLY                         in the procedure, and especially the use of a hand, pure
INVASIVE SURGERY                                                                 virtual reality could not be considered as a solution.

Introduction                                                                     The ProMIS Augmented Reality simulator platform – by
                                                                                 combining physical and virtual reality - enables interaction
Minimally invasive surgery is becoming the standard of care for
                                                                                 and tracking of real instruments with a physical model. And
the majority of abdominal procedures. Laparoscopic
                                                                                 because of its technological approach (vision-tracking) also
instrumentation is constantly undergoing improvements to give
                                                                                 enables the hand to be tracked. In the new ProMIS HALC
surgeons an advantage. Articulated instrumentation provides a
                                                                                 simulator, 3D models or graphical objects are overlaid on
distinct advantage in the field of robotic surgery. Applying the
                                                                                 the physical model to provide instruction and guidance. For
same principles to standard laparoscopic instrumentation could
                                                                                 example, a 3D animation may be used to demonstrate how
offer increased degrees of freedom to make complex
                                                                                 to complete a step; a graphical guideline ‘A – B’ may be
laparoscopic tasks easier to perform. We utilized a novel
                                                                                 used to indicate a target area for dissection. ProMIS HALC
computerized assessment system to objectively evaluate task
                                                                                 measures surgical skill by gathering data on the movement
performance comparing Standard and High Dexterity (HD)
                                                                                 of commercial laparoscopic instruments while completing a
laparoscopic instrumentation.
                                                                                 standardized task. The main performance metrics are time
Methods                                                                          taken, total path length and economy of movement.
                                                                                 Additionally metrics specific to a step are calculated to
Advanced laparoscopic surgeons (2-12yrs experience) performed
                                                                                 measure performance associated with a specific instruction
3 unique task modules utilizing Standard and HD laparoscopic
                                                                                 in a specific region of the physical model. Following the
instrumentation (Novare Surgical Systems, Cupertino, CA).
                                                                                 simulated procedure, the user completes a self-assessment
Performance was evaluated using a computerized assessment
                                                                                 which contributes to the metrics for the full procedure. A
system (ProMIS, Dublin, Ireland) and results were recorded as
                                                                                 full analysis is of performance is presented to the user on
time (sec), path (mm), and precision. Each surgeon had an initial
                                                                                 completion of the procedure and self-assessment.
training session followed by two testing sessions for each
module. A Paired Student’s T-Test was used to analyze the data.                  Results
Results: Nine surgeons completed the study. Objective
                                                                                 Initial trials of the ProMIS HALC simulator indicate that
assessment of the data is presented in the table below. Module 1
                                                                                 practice on the simulator improves performance as
was statistically significant, whereas Module 2 and 3 showed no
                                                                                 measured by the metrics gathered by the simulator. While
difference in task performance with the HD instrumentation.
                                                                                 detailed validation studies remain to be done, initial
Conclusion                                                                       indicators are that the HALC simulator represents an
                                                                                 “unparalleled opportunity to practice, step by step, a Hand-
HD instrumentation is in its infancy. Results showed no
                                                                                 assisted laparoscopic sigmoid resection” and “a huge step
advantage using HD instrumentation. This could be due to the
                                                                                 forward in surgical training”.
learning curve associated with new instrumentation and
technology. With future developments in HD technology and
training, the user interface will improve and may offer an
advantage over standard laparoscopic instrumentation.




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Validation
18. May 2006 North of England Surgical Society Annual                            19. EAES 2006, Poster
       Registrar’s Meeting   Winner of the George Feggeter Gold Medal            DEVELOPING PSYCHOMETRIC ASSESSMENT OF
LAPAROSCOPIC SKILLS ACQUISITION: IS PSYCHOMETRIC                                 LAPAROSCOPIC SKILLS USING THE PROMIS SIMULATOR
MOTION ANALYSIS A VALID ASSESSMENT TOOL?                                         Pellen MGC1;2, Barton JR2, Horgan LF1, Attwood SE1
            1;2         2                1               1
Pellen MGC , Barton JR , Horgan LF , Attwood SE Northumbria                      Northumbria Upper Gastrointestinal Team of Surgeons1;
Upper Gastrointestinal Team of Surgeons1; University of                          University of Newcastle upon Tyne2, United Kingdom
Newcastle upon Tyne2, Newcastle upon Tyne, United Kingdom
                                                                                 Aims
Aims
                                                                                 Reliable and validated methods of objective skills training
In an evolving climate of competency-based assessment, reliable                  and assessment are required for trainee surgeons. The
and validated methods of objective skills assessment are                         ProMIS Simulator (Haptica, Ireland) potentially offers a
required for trainee surgeons. We aimed to assess whether the                    method of assessing laparoscopic psychomotor performance.
ProMIS Simulator (Haptica, Dublin, Ireland) offers a method of                   We present initial data from our Centre and Royal College of
assessing laparoscopic psychomotor performance.                                  Surgeons Basic Surgical Skills (BSS) Courses.

Methods                                                                          Methods and results

Volunteers comprising 17 experienced laparoscopists ( >100                       Volunteers comprising 17 experienced laparoscopists (>100
laparoscopic cholecystectomies) and 38 medical students novices                  laparoscopic cholecystectomies) and 38 medical students
(no laparoscopic experience) performed 3 simulated tasks                         novices (no laparoscopic experience) were assessed on a
comprising virtual reality camera navigation, object transfer and                complex sharp dissection task (glove over balloon). A
sharp dissection task (glove over balloon). A further group of 28                further group of 28 basic surgical trainees (experience
basic surgical trainees (experience limited to 1st assistant)                    limited to 1st assistant) attending BSS Courses were assessed
attending BSS Courses were assessed on the same tasks before                     on the same task before and after training in laparoscopic
and after training in laparoscopic skills. Data metrics of time,                 skills. Data metrics of time, smoothness and path length
smoothness and path length were measured via optical tracking                    were measured via optical tracking of instrum-ent
of instrument movement. Objective observations of specific                       movement as well as observations of specific errors.
errors were also recorded.
                                                                                 Data analysis (ANOVA) demonstrated experienced
Results                                                                          laparoscopists performed target dissection at least 50%
                                                                                 faster, smoother and with more economy of instrument
Non-parametric analysis demonstrated experienced
                                                                                 movement than students (p<0.05). Experienced participants
laparoscopists performed all 3 tasks significantly faster,
                                                                                 performed sharp dissection more accurately (p<0.01)
smoother and with more economy of movement (p<0.05),
                                                                                 although no difference in balloon puncture frequency was
excluding camera navigation path length. Experienced
                                                                                 seen. Similarly significantly better performance over
participants performed sharp dissection more accurately (p<0.01)
                                                                                 trainees was demonstrated. Trainees showed only
although no difference in balloon puncture was seen. Repeat
                                                                                 significantly smoother instrument handling when compared
assessment of BSS Course Trainees showed significant
                                                                                 to students, possibly reflecting greater baseline dexterity in
improvements in simulator metrics (Paired T test, P<0.05),
                                                                                 this selective group. Repeat assessment following course
although smaller yet significant improvements in “untrained”
                                                                                 training showed significant improvements in all metrics by
student performance was also seen.
                                                                                 32-40% (Paired T test, P<0.05). Whilst significant
Conclusions                                                                      improvements were also demonstrated in repeat assessment
                                                                                 of the untrained student group, these were less marked (15-
Gross analysis of these metrics can distinguish between                          18%).
experience levels supporting construct validity of these simulator
tasks. These results suggest potential for objectively measuring                 Conclusions
baseline skill level and response to training. Further work will
                                                                                 The gross analysis of these metrics can distinguish between
examine the effect of interface familiarisation and defining
                                                                                 experience levels supporting the construct validity of this
target levels of performance in simulated tasks.
                                                                                 simulator task. These results suggest a potential role for
                                                                                 objectively measuring baseline skill level and response to
                                                                                 training in distinct psychomotor challenges. Further work in
                                                                                 progress is examining the effect of interface familiarisation
                                                                                 and repeated task performance on novice learning curves
                                                                                 and defining target levels of performance in a range of
                                                                                 simulated tasks.




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Validation
20. Surg Endosc (May 2006) 20: 900–904                                           21. Surgical endoscopy ISSN: 0930-2794 (Paper) 1432-
CONSTRUCT VALIDATION OF A NOVEL HYBRID SURGICAL                                         2218 (Online)
SIMULATOR                                                                        CONSTRUCT VALIDATION OF THE PROMIS SIMULATOR
D. Broe, P. F. Ridgway, S. Johnson, S. Tierney, K. C. Conlon                     USING A NOVEL LAPAROSCOPIC SUTURING TASK
Department of Surgery, Professorial Surgical Unit, Level 4, The                  K. R. Van Sickle1, D. A. McClusky III1, A. G. Gallagher and
Adelaide and Meath Hospital, incorporating the National                          C. D. Smith1
Children’s Hospital, Tallaght, Dublin 24, Ireland
                                                                                 Background
Background
                                                                                 The use of simulation for minimally invasive surgery (MIS)
Simulated minimal access surgery has improved recently as both                   skills training has many advantages over current traditional
a learning and assessment tool. The construct validation of a                    methods. One advantage of simulation is that it enables an
novel simulator, ProMis, is described for use by residents in                    objective assessment of technical performance. The
training.                                                                        purpose of this study was to determine whether the ProMIS
                                                                                 augmented reality simulator could objectively distinguish
Methods
                                                                                 between levels of performance skills on a complex
ProMis is a surgical simulator that can design tasks in both virtual             laparoscopic suturing task.
and actual reality. A pilot group of surgical residents ranging
                                                                                 Methodology
from novice to expert completed three standardized tasks:
orientation, dissection, and basic suturing. The tasks were tested               Ten subjects — five laparoscopic experts and five
for construct validity. Two experienced surgeons examined the                    laparoscopic novices — were assessed for baseline
recorded tasks in a blinded fashion using an objective structured                perceptual, visio-spatial, and psychomotor abilities using
assessment of technical skills format (OSATS: task-specific                      validated tests. After three trials of a novel laparoscopic
checklist and global rating score) as well as metrics delivered by               suturing task were performed on the simulator, measures
the simulator.                                                                   for time, smoothness of movement, and path distance were
                                                                                 analyzed for each trial. Accuracy and errors were evaluated
Results
                                                                                 separately by two blinded reviewers to an interrater
The findings showed excellent interrater reliability (Cronbach_s                 reliability of >0.8. Comparisons of mean performance
a of 0.88 for the checklist and 0.93 for the global rating). The                 measures were made between the two groups using a Mann-
median scores in the experience groups were statistically                        Whitney U test. Internal consistency of ProMIS measures was
different in both the global rating and the task-specific                        assessed with coefficient α.
checklists (p < 0.05). The scores for the orientation task alone
                                                                                 Results
did not reach significance (p = 0.1), suggesting that modification
is required before ProMis could be used in isolation as an                       The psychomotor performance of the experts was superior
assessment tool.                                                                 at baseline assessment (p < 0.001). On the laparoscopic
                                                                                 suturing task, the experts performed significantly better
Conclusions
                                                                                 than the novices across all three trials (p < 0.001). They
The three simulated tasks in combination are construct valid for                 performed the tasks between three and four times faster (p
differentiating experience levels among surgeons in training.                    < 0.0001), had three times shorter instrument path length
This hybrid simulator has potential added benefits of marrying                   (p < 0.0001), and had four times greater smoothness of
the virtual with actual, and of combining simple box traits and                  instrument movement (p < 0.009). Experts also showed
advanced virtual reality simulation.                                             greater consistency in their performance, as demonstrated
                                                                                 by SDs across all measures, which were four times smaller
                                                                                 than the novice group. Observed internal consistency of
                                                                                 ProMIS measures was high (α = 0.95, p < 0.00001).

                                                                                 Conclusions

                                                                                 Preliminary results of construct validation efforts of the
                                                                                 ProMIS simulator show that it can distinguish between
                                                                                 experts and novices and has promising psychometric
                                                                                 properties. The attractive feature of ProMIS is that a wide
                                                                                 variety of MIS tasks can be used to train and assess technical
                                                                                 skills.




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Validation
22. EAES 2004 Abstract nr.: O207                                                23. EAES 2004 abstract nr.: O208
RELATIONSHIP BETWEEN MOTION ANALYSIS, TIME,                                     PSYCHOMOTOR SKILLS ASSESSMENT IN PRACTICING
ACCURACY, AND ERRORS DURING PERFORMANCE OF A                                    SURGEONS PERFORMING ADVANCED LAPAROSCOPIC
LAPAROSCOPIC SUTURING TASK ON AN AUGMENTED REALITY                              PROCEDURES II: DEMOGRAPHICS AND PERFORMANCE
SIMULATOR                                                                       PROFILES
Author: D.A.M. McClusky, Emory University School of Medicine,                   Author: A.G. Gallagher, Emory University, Atlanta, United
Atlanta Georgia, United States of America. Co-author(s): K. Van                 States of America. Co-author(s): C.D. Smith, Emory
Sickle, Emory University School of Medicine, Atlanta Georgia,                   University, Atlanta, United States of AmericaR.M. Satava,
United States of America                                                        University of Washington, Seattle, United States of America
A.G. Gallagher, Emory University School of Medicine, Atlanta
                                                                                Background
Georgia, United States of America
                                                                                This study reports on the objectively assessed psychomotor
Background
                                                                                performance of minimally invasive surgeons on a box-trainer
Time, efficient movement, accuracy, and safety are reliable and                 and a virtual reality (VR) task as a function of handedness,
discriminative metrics of proficiency during virtual reality and                gender, sight corrected status, and age. Methods: Two
box-trainer based minimally invasive surgical (MIS) training. The               hundred and ten surgeons attending the 2001 annual
role these metrics may serve during more advanced skills training               meeting of the American College of Surgeons (ACS) in New
are not well understood. Using a novel augmented reality                        Orleans who reported having completed more than 50
simulator, we sought to gain an understanding of the relationship               laparoscopic procedures participated. Subjects completed a
between these metrics during an advanced MIS suturing task.                     box-trainer laparoscopic cutting task and a similar virtual
Methods: Eleven subjects completed 3 trials of a suturing task                  reality task twice. Demographic and laparoscopic
designed for a box-trainer and adapted for the ProMIS (Haptica,                 experience data was also collected. Results: There were no
Dublin, Ireland) simulator. Time, tool path, and smoothness of                  significant differences between subjects performance on
movement were assessed using computer algorithms. Measures of                   either tasks in terms of handedness, gender or whether they
accuracy during suture placement and errors in performance                      were sight corrected or not. A clear and consistent linear
were assessed by two blinded reviewers trained to assess                        trend emerged in terms of age. Older subjects (ages 60 – 69)
performance with inter-rater reliability > 0.8. A Pearson’s                     performed significantly worse than younger subjects (ages
correlation coefficient was used to assess the strength of the                  30 – 39, 40 – 49) on the box-trainer task for correct incisions
relationship between ProMIS metrics and suturing task                           (13.1 Vs 19.3, p < 0.008) and incorrect incisions (12.3 Vs 2.5,
performance. Results: Of the ProMIS metrics, time correlated                    p > 0.05). They also performed worse on the VR task for
with tool path distance and smoothness of movement in three                     time (132 Vs 71, p < 0.05), error (99 Vs 41, p < 0.05) and
trials (range 0.914 – 0.957, p < 0.0001). When the suturing task                economy of movement (22.8 Vs 11.7, p < 0.05). Conclusions:
was analyzed, accuracy and error score demonstrated an equally                  Increasing age was found to be associated with a decline in
strong relationship (range -0.726 - -0.84, all p < 0.0001).                     objectively assessed psychomotor performance on two well
Combining all metrics, path distance correlated strongest with                  validated laparoscopic tasks.
accuracy (2 trials significant, range -0.67 - -0.93), and error
                                                                                Acknowledgements
score (3 trials significant, range 0.54 – 0.61). Smoothness of
movement significantly correlated with accuracy in 2 trials                     This study was supported with grants from the ACS, SAGES,
(range -0.63 - -0.88), and time correlated with error score in 2                SLS, TATRC, and Emory University Endosurgery Unit.
trials (range 0.56 – 0.60).

Conclusion

Metrics based on movement efficiency and time, and those based
on task accuracy and error scores strongly correlate when
grouped independently. At this time, a proficiency curriculum
should incorporate both forms of analysis, however further
validation work is needed to replicate these findings and give
further insight into how ProMIS metrics relate to real-world
performance.




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Validation
24. JSLS, Journal of the Society of Laparoendoscopic                             25. SAGES 2008 P174
      Surgeons, Vol. 11, No. 3. (September 2007), pp. 273-                       FLS TEST IS TRANSFERABLE TO PROMIS SIMULATOR
      302.                                                                       Eric S Hungness MD, Albert Amini BA, Deb E Rooney MS, Eric
CRITERION-BASED TRAINING WITH SURGICAL SIMULATORS:                               T Volckman MD, Nathaniel J Soper MD, Feinberg School of
PROFICIENCY OF EXPERIENCED SURGEONS                                              Medicine, Northwestern University, Chicago, IL
Heinrichs, Wm, Lukoff, Brian, Youngblood, Patricia, Dev, Parvati,
                                                                                 Introduction
Shavelson, Richard, Hasson, M Harrith, Satava, M Richard,
                                                                                 The McGill Inanimate System for Training and Evaluation
Mcdougall, M Elspeth, Wetter, Paul Alan
                                                                                 of Laparoscopic Skills (MISTELS) comprises five tasks with
Objective                                                                        an objective scoring system, and has been incorporated
                                                                                 by SAGES in their Fundamentals of Laparoscopic Surgery
In our effort to establish criterion-based skills training for                   (FLS) program. MISTELS has high inter-rater and test-
surgeons, we assessed the performance of 17 experienced                          retest reliability and correlates with operative skill.
laparoscopic surgeons on basic technical surgical skills recorded                However, the FLS program is labor intensive, requiring a
electronically in 26 modules selected in five commercially                       trained proctor. The ProMIS simulator allows for
available, computer-based simulators.                                            assessment of physical tasks (instrument path length and
                                                                                 instrument smoothness) through instrument tracking
Methods/Procedures                                                               technology. We hypothesized that the FLS scores
                                                                                 obtained in the ProMIS simulator as well as ProMIS
Performance data were derived from selected surgeons randomly                    metrics would correlate with standard FLS scoring.
assigned to simulator stations, and practicing repetitively during
three one-half day sessions on five different simulators. We                     Methods
measured surgeon proficiency defined as efficient, error-free                    Twenty general surgery residents (13 junior and 7 senior)
performance and developed proficiency score formulas for each                    had baseline laparoscopic skills assessed using MISTELS in
module. Demographic and opinion data were also collected.                        the standard FLS and ProMIS simulators (pre-test). Nine
                                                                                 junior and 4 senior residents had a post-test after four
Results                                                                          weeks of training. Tasks were scored by FLS and ProMIS
                                                                                 metrics. Total path length (TP) and total smoothness (TS)
Surgeons’ performance demonstrated a sharp learning curve with                   were calculated by adding the path lengths and
the most performance improvement seen in early practice                          smoothness of each individual task. ANOVA was used to
attempts. Median scores and performance levels at the 10th,                      compare the mean (SD) of total and individual task scores
25th, 75th, and 90th percentiles are provided for each module.                   for pre- and post-tests in the FLS and ProMIS simulators.
Construct validity was examined for two modules by comparing                     Student's t-test was used to compare ProMIS metrics.
experienced surgeons’ performance with that of a convenience                     Pearson's correlations were calculated for standard FLS
sample of lessexperienced surgeons.                                              scores in relation to ProMIS FLS scores, TP and TS.
                                                                                 Significance was defined as p < 0.01.
Conclusions
                                                                                 Results
A simple mathematical method for scoring performance is                          All residents showed statistically significant improvement in
applicable to these simulators. Proficiency levels for training                  post-test total and individual task FLS scores on either the
courses can now be specified objectively by residency directors                  FLS or ProMIS simulator. 100% and 88% of residents achieved
and by professional organizations for different levels of training               passing post-test scores on the FLS and ProMIS simulator,
or post-training assessment of technical performance. But data                   compared to 30% and 29.2% on the pre-test. There was no
users should be cautious due to the small sample size used in this               difference in junior and senior resident posttest scores (87.6
study and the need for further study into the reliability and                    vs 79.1). ProMIS path length and smoothness were
validity of the use of surgical simulators as assessment tools.                  significantly reduced across all tasks (range 14- 68%). Total
                                                                                 ProMIS FLS scores (0.729), TP (-0.753) and TS (- 0.769)
Summary comment
                                                                                 significantly correlated with total standard FLS simulator
The simulators used included pure Virtual Reality Simulators and                 scores. All residents with TP < 4000mm or TS < 6000
two simulators with real haptics (including ProMIS): Lap Mentor                  achieved a passing total FLS score.
from Simbionix (pure Virtual Reality); LapSim from Surgical-
                                                                                 Conclusions
Science AB (pure Virtual Reality); SurgicalSIM from METI (pure
Virtual Reality); ProMIS from Haptica (real haptics with metrics);               All surgical residents achieved a passing FLS score after a
LTS2000 ISM60 from RealSim (real haptics with metrics).                          4-week laparoscopic skills curriculum. FLS tasks are
                                                                                 transferable to the ProMIS simulator with traditional FLS
ProMIS out-performed the virtual reality simulators with a mean                  scoring and intrinsic ProMIS metrics being good
effectiveness rating of 3.56 versus 3.22 and 3.11 for LapSim and                 measurement tools. A ProMIS total path length <4000 mm
SurgicalSim (LapMentor also scored 3.56).                                        or total smoothness <6000 reliably predicts a passing FLS
                                                                                 score.



                       www.haptica.com | email: promis@haptica.com | tel (NAm) +617 342 7270 | tel (RoW) +353 (0) 1 676 7310

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Att11

  • 1. Validated! Proven wiith FLS Proven w th FLS Better than VR Better than VR Preferred by users Preferred by users ProMIS and FLS • ProMIS metrics are “excellent predictors of scores in the standard FLS simulator” and “predict readiness for FLS Certification”1 2 3 • ProMIS metrics are valid on peg transfer, pre-tied loop placement and knot-tying tasks4 • “Initial trials of the metrics on the FLS Precision- Cutting Task show that ProMIS is as accurate as 5 the current method” ProMIS assesses performance on Augmented Reality combines VR real models where real haptics with a physical model allowing • FLS tasks are transferable to the ProMIS simulator are important, eg in Suturing and virtual bleeding and real haptics. Knot-tying with traditional FLS scoring and intrinsic ProMIS metrics being good measurement tools. A ProMIS total path length <4000 mm or total smoothness 25 <6000 reliably predicts a passing FLS score. ProMIS vs pure VR • ProMIS out-performed the virtual reality 24 simulators ProMIS has pure VR Modules, eg Vision technology enables • Scores for ProMIS were significantly higher than for Instrument Handling. Users tracking of errors and automatic still use real instruments. calculation of dissected tissue. for SurgicalSIM for overall realism, thread behavior, reflection of clinical ability, and overall educational value.6 • In comparison with LapSim, ProMIS was regarded by all participants as a better simulator for laparoscopic skills training on all tested features7 ProMIS surgical simulator • “Only [ProMIS] was able to distinguish between advanced trainees and beginners (and) was ProMIS Modules range from Basic Laparoscopic Skills to graded more realistic (70% vs 33%) and more MIS procedures like LapColectomy. For more information useful (83% vs 62%)” than Xitact8 on ProMIS, please contact us at: • The ability of performance metrics of [ProMIS] to Email: promis@haptica.com discern predicted performance differences U.S. tel: +1 617 342 7270 between experts and non-experts was better RoW tel: +353 (0)1 676 7310 than for SimSurgery’s robotic surgery simulator and 1 SAGES 2006 S064 Ritter et al, SurgicalSIM 9 2 SAGES 2006 P237 McCluney MD, et al, 3 4 SAGES 2007 P279 McCluney et al, ProMIS: the preferred Simulator SAGES 2006 S065 Vuong et al, 5 SAGES 2007 ETP057 Young et al, • ProMIS can be used effectively with the DaVinci 6 SAGES 2006 P224 Fellinger, et al, 7 robot to obtain performance data with robotic World J Surg. 2007 Apr;31(4):764-72. Botden et al, 8 SAGES 2007 P270 Hahnloser et al, instrumentation10 9 SAGES 2007 S077 Lin et al, 10 SAGES 2006 Narula et al, • Residents believe that ProMIS is easy to use and 11 24 SAGES 2006 P219 Chang et al, improved their operative skills11 Heinrichs, et al 2007 25 Hungness, et al 2008
  • 2. Validation 1. SAGES 2006 Scientific Session S064 2. SAGES 2006 Education/Outcomes–P237 CONCURRENT VALIDITY OF AUGMENTED REALITY METRICS VALIDATION OF THE PROMIS HYBRID SIMULATOR USING APPLIED TO THE FUNDAMENTALS OF LAPAROSCOPIC A STANDARD SET OF LAPAROSCOPIC TASKS SURGERY (FLS) A L McCluney MD, L S Feldman MD, G M Fried, Steinberg- E. Matt Ritter MD, Tamara W Kindelan MD, Curtis Michael, Bernstein Centre for Minimally Invasive Surgery, McGill Elisabeth A Pimentel BA, Mark W Bowyer MD, 1NCA Medical University Health Centre, Montreal, QC, Canada Simulation Center, Department of Surgery, Uniformed Services Introduction University, 2Division of General Surgery, National Naval Medical Center, Bethesda Maryland SAGES Fundamentals of Laparoscopic Surgery (FLS) tasks are validated measures of technical skills, however FLS scoring Objective requires a trained proctor. The ProMIS simulator (Haptica; Current skills assessment in the Fundamentals of Laparoscopic Dublin, IR) is a ‘hybrid’ system with physical and virtual Surgery (FLS) program is labor intensive requiring one proctor for reality tasks. It has the flexibility to incorporate any every 1-2 subjects. The ProMIS Augmented Reality (AR) simulator physical task and score it with ProMIS metrics. Metrics are (Haptica, Dublin IRE) allows for objective assessment of physical automated and report motion analysis data as instrument tasks through instrument tracking technology. We hypothesized path length (PL) and instrument smoothness (IS). The that the ProMIS metrics could differentiate between ability purpose of this study was to test for construct and groups as well as standard FLS scoring with fewer personnel concurrent validity using FLS tasks in the ProMIS simulator. requirements. Methods Methods 5 laparoscopic novices and 5 experts performed FLS tasks in We recruited 60 volunteer subjects. Subjects were stratified both the standard FLS simulator box and the ProMIS based on their laparoscopic surgical experience. Those who had simulator. Assessments were made based on FLS metrics, as performed more than 100 laparoscopic procedures were well as PL and IS. Student’s t-test was used to compare the considered experienced (n=8). Those with less than 10 mean (SD) of total scores for novices and experts. Pearson’s laparoscopic procedure were considered novices (n=44). The rest correlations were calculated for standard FLS scores in were intermediates (n=8). All subjects performed up to 5 trials relation to ProMIS FLS scores, total PL, and total IS. of the peg transfer task from FLS in the ProMIS simulator. FLS Significance was defined as p < 0.01 (*). score, instrument path length, and instrument smoothness Results assessment were generated for each trial. Standard FLS scores correlated strongly with ProMIS FLS Results scores (r=0.90), total PL (r=-0.83), and total IS (r=-0.78) For each of the 5 trials, experienced surgeons outperformed (p&lt; 0.01). intermediates who in turn out performed novices. Statistically Conclusions significant differences were seen between the groups across all trials for FLS score (p < 0.001), ProMIS path length (p <0.001) and FLS tasks performed in ProMIS, when scored by either ProMIS smoothness (p < 0.001). When the FLS score was traditional FLS metrics or by intrinsic ProMIS metrics, compared to the path length and smoothness metrics, a strong discriminate effectively between novices and experts. Based relationship between the scores was apparent for novices (r = on the observed correlations, ProMIS FLS scores, total PL, 0.78, r = 0.94 , p < 0.001) respectively), intermediates (r = 0.5, p and total IS are excellent predictors of scores in the = 0.2 , r = 0.98, p < 0.001), and experienced surgeons (r = 0.86, p standard FLS simulator. = 0.006, r = 0.99, p < 0.001) Conclusions The construct that the standard scoring of the FLS peg transfer task can discriminate between experienced, intermediate, and novice surgeons is validated. The same construct is valid when the task is assessed using the metrics of the ProMIS. The high correlation between these scores establishes the concurrent validity of the ProMIS metrics. The use of AR for objective assessment of FLS tasks could reduce the personnel requirements of assessing these skills while maintaining the objectivity. www.haptica.com | email: promis@haptica.com | tel (NAm) +617 342 7270 | tel (RoW) +353 (0) 1 676 7310
  • 3. Validation 3. SAGES 2007 Education/Outcomes – P279 4. SAGES 2006 Scientific Sessions S065 AUTOMATED PROMIS SIMULATOR METRICS PREDICT WHAT CAN MOTION DERIVATIVES TELL US ABOUT SKILL READINESS FOR FLS CERTIFICATION PERFORMANCE? Anthony L McCluney MD, J Cao, G N Polyhronopoulos MD, D D Laurel N Vuong BS, Steven D Schwaitzberg MD, Caroline G Stanbridge, L S Feldman MD, G M Fried MD, Steinberg-Bernstein Cao PhD, Tufts University School of Medicine, Cambridge Centre for Minimally Invasive Surgery, McGill University, Health Alliance, Tufts University School of Engineering Montreal, QC, Canada Surgical simulators are a popular topic of discussion on Introduction training in laparoscopic surgery. They reduce the need to use human cadavers or animal models for skills SAGES Fundamentals of Laparoscopic Surgery (FLS) tasks are development. A subset of the MISTELS methodology has validated measures of technical skills. Certification requires been employed in the manual skills assessment for the travel to a testing site and a fee, thus a reliable method of Fundamentals Laparoscopic Skills (FLS) program because it predicting readiness for the exam would be advantageous. The was shown to be a valid discriminator of surgical ProMIS simulator (Haptica) provides automated scoring. FLS tasks experience. Pure performance outcome, such as time to can be placed in the ProMIS simulator and scored using time task completion and number of errors, is used for scoring, (TT), as well as motion analysis metrics: instrument path length which is dependent on the consistency of the scorer. A new (PL) and instrument smoothness (IS). This study was designed to simulator environment has been created which uses motion evaluate these automated ProMIS metrics and their ability to tracking for measurement of performance outcome predict readiness for FLS certification. measures and motion derivatives such as smoothness and Methods efficiency. 33 subjects (12 students, 16 residents PGY 1-4, and 5 experts) The purpose of the study was to determine if the motion performed FLS tasks in the standard simulator and in ProMIS. derivatives can be used to automatically and objectively Tasks were scored by FLS and ProMIS metrics. For each ProMIS discriminate experience levels. Twenty-one subjects (6 metric, the total score was calculated by summing the scores for medical students, 14 surgical residents, and 1 expert the 5 FLS tasks. Pearson’s correlations were calculated for surgeon) were recruited to perform the following tasks: peg ProMIS metrics versus standard FLS scores. Multivariate transfer, pattern cutting, pre-tied loop placement, regression analysis identified independent predictors of standard extracorporeal and intracorporeal knot-tying in the new FLS performance. These variables were then used for sensitivity simulator environment. Subjects were evaluated on time to and specificity calculations in order to establish a ProMIS pass- completion, errors, smoothness and total path length (used fail score for predicting readiness for FLS certification. to calculate efficiency). Significance was defined as p<0.05. Results show that experience level is still distinguishable when using task-dependent parameters to evaluate Results performances during peg transfer (p= 0.035), pre-tied loop TT (r= -0.82), PL (r= -0.56), and IS (r= -0.75) all correlated placement (p= 0.022), extracorporeal (p= 0.0006) and significantly with standard FLS score. Multivariate regression intracorporeal (p= 0.025) knot tying in this new simulator analysis identified TT as the strongest predictor of FLS score. A environment. TT score of 1000 maximizes sensitivity and specificity and was Evaluation of performance using task-independent identified as the pass-fail for reliably predicting FLS parameters significantly distinguished training level in three performance. tasks: (1) smoothness of the left instrument was significant Conclusions as a function of experience level in extracorporeal knot- tying (p= 0.016), (2) efficiency (total path length divided by Automated ProMIS metrics correlate well with standard FLS time to completion) was also significant in the movement of performance. In this study sample, a TT score less than 1000 the right tool as a function of experience level in peg reliably predicted a passing FLS certification score. transfer (p= 0.0011) and (3) pre-tied loop placement (p= 0.013979). This preliminary analysis shows that automatic and objectively measured motion derivatives can be associated with the level of experience. These results indicate a potential for the application of an automatic and objective means of skills evaluation. www.haptica.com | email: promis@haptica.com | tel (NAm) +617 342 7270 | tel (RoW) +353 (0) 1 676 7310
  • 4. Validation 5. SAGES 2007 ETP057 6. SAGES 2006 Education/Outcomes–P224 OBJECTIVE MEASUREMENT OF FLS PRECISION CUTTING TASK COMPLEX LAPAROSCOPIC TASK PERFORMANCE ON TWO Derek Young, Fiona Slevin, Derek Cassidy, Donncha Ryan, Haptica NEW COMPUTER-BASED SKILLS TRAINING DEVICES Inc Erika K Fellinger MD, Michael E Ganey MD, Anthony G Gallagher PhD, Daniel J Scott MD, Ron W Bush BS, Neal E The Precision-Cutting Task in the SAGES/ACS FLS Program Seymour MD, Department of Surgery, Baystate Medical requires the user to dissect a circle of specific size and shape Center, Springfield, MA from a marked piece of mesh. Currently, measurement of the accuracy and area dissected is done by observation and by Introduction measuring the dissected mesh on a measurement grid. Using New computer-based skills training devices can simulate and advanced vision-tracking, the ProMIS surgical simulator takes an measure performance of complex surgical tasks. The aim of image of the dissected mesh and automatically generates a this study is to determine basic face and construct validity metric, indicating the accuracy of the shape and area dissected. characteristics of two new devices configured for Method laparoscopic suturing and knot-tying tasks. 1. Once the user has completed the Precision-Cutting Task, Methods ProMIS takes an image of the dissected mesh. The image is At the 2005 SAGES meeting, Learning Center attendees converted to binary image and then scanned using a blob evaluated two computer-based skills training platforms: detection algorithm which produces a list of blobs. SurgicalSIM (SS), a virtual reality (VR) device (METI, 2. The blob with the largest area is taken as the cut out area and Sarasota, FL; SimSurgery, Oslo, Norway) and ProMIS (PM), a the number of pixels are counted inside this area. computer-enhanced video trainer (Haptica, Ltd., Dublin, Ireland). Demographic and training data were collected 3. The actual measurement for area is given in cm2. This is from 73 subjects. All were asked to perform 2 iterations of calculated by counting the number of pixels in a known area of laparoscopic suturing and intracorporeal knot-tying (10- the image and then using ratios to determine the area of the cut minute time limit) on each device. A 6-question survey was out. (Note: this calibration step is achieved by taking the tissue used to define impressions of task realism, relevance, and off the tray and running the blob detection and pixel count on execution using a 5-point Likert scale. Performance data the uncovered black foam of which the exact area is known) (SS: time, path length, errors; PM: time, path length, Results smoothness) were collected on both devices and comparisons made between user-defined expert and Initial trials of the metrics on the FLS Precision- Cutting Task nonexpert (intermediate and novice) groups (ANOVA and show that ProMIS is as accurate — and frequently more accurate Mann Whitney U test). — than the current human observation method. Results 46 subjects used SS and 56 used PM. Task completion rate was 80% for SS and 93% for PM. Experts performed better than nonexperts for all performance measures on SS (composite score 496±41 vs 699±60, p < 0.005) and PM (974±111 vs 1466±89, p < 0.005). Post-task survey scores for PM were significantly higher for perceived realism (overall realism and thread behavior), reflection of clinical ability, and overall educational value. Perception of educational value was not significantly different between the devices among subjects with prior VR experience. Conclusions Using subject-defined expert and nonexpert groups, construct validity was demonstrated for all performance measures on both training devices. Surveyed face validity measures favored the non-VR device, but results also suggest that subjects with prior VR training experience are more apt to accept a new VR surgical training platform. www.haptica.com | email: promis@haptica.com | tel (NAm) +617 342 7270 | tel (RoW) +353 (0) 1 676 7310
  • 5. Validation 7. World J Surg. 2007 Apr;31(4):764-72. 8. SAGES 2007 Education/Outcomes – P270 AUGMENTED VERSUS VIRTUAL REALITY LAPAROSCOPIC COMPARISON AND VALIDATION OF TWO DIFFERENT SIMULATION: WHAT IS THE DIFFERENCE? : A COMPARISON SURGICAL SKILLS SIMULATORS OF THE PROMIS AUGMENTED REALITY LAPAROSCOPIC Dieter Hahnloser MD,Rachel Rosenthal MD,Christian SIMULATOR VERSUS LAPSIM VIRTUAL REALITY Hammel,Daniel Oertli,Markus Müller,Pierre-Alain Clavien, LAPAROSCOPIC SIMULATOR. Department of Visceral and Transplantation Surgery, Botden SM, Buzink SN, Schijven MP, Jakimowicz JJ. Catharina University Hospital Zurich, Switzerland Hospital, Eindhoven, The Netherlands. Background Background Simulators are increasingly incorporated in surgical training Virtual reality (VR) is an emerging new modality for laparoscopic and validation is important. The simulations need to skills training; however, most simulators lack realistic haptic resemble the task they are based upon (face validity) and feedback. Augmented reality (AR) is a new laparoscopic the simulator should be able to differentiate between levels simulation system offering a combination of physical objects and of experience (construct validity). VR simulation. Laparoscopic instruments are used within an Aim hybrid mannequin on tissue or objects while using video tracking. This study was designed to assess the difference in realism, To assess two different types of computer-based simulators: haptic feedback, and didactic value between AR and VR the fully computerised virtual reality (VR) simulator Xitact laparoscopic simulation. LS500 (VR-simulator) and the hybrid ProMisTM simulator. Methods: 146 participants (61%) of the 22nd Davos Methods International Gastrointestinal Surgery Workshop performed The ProMIS AR and LapSim VR simulators were used in this study. on a voluntary basis three similar exercises (camera The participants performed a basic skills task and a suturing task navigation, clip and cut, and dissection) on the two on both simulators, after which they filled out a questionnaire different simulators. Objective performance parameters about their demographics and their opinion of both simulators recorded by either simulator and subjective evaluation by scored on a 5-point Likert scale. The participants were allotted questionnaire were compared between beginner (n=73) and to 3 groups depending on their experience: experts, advanced participants (n=73). intermediates and novices. Significant differences were Results calculated with the paired t-test. The camera navigation exercise was completed by 52% of Results the participants on the VR- and by 47% on the hybrid There was general consensus in all groups that the ProMIS AR simulator with no difference in performance parameters laparoscopic simulator is more realistic than the LapSim VR between beginners and advanced trainees. The hybrid laparoscopic simulator in both the basic skills task (mean 4.22 simulator was graded more realistic (70% vs. 20%, p=.001) resp. 2.18, P < 0.000) as well as the suturing task (mean 4.15 and more useful (65% vs. 36%, p=.043) than the VR- resp. 1.85, P < 0.000). The ProMIS is regarded as having better simulator. Participation was higher at the clip and cut haptic feedback (mean 3.92 resp. 1.92, P < 0.000) and as being exercise (75% VR- and. 52% hybrid simulator) and advanced more useful for training surgical residents (mean 4.51 resp. 2.94, trainees performed significantly better (shorter tool-tip- P < 0.000). travel distance, smoother, quicker and with higher score) on both simulators compared to beginners. The clip and cut Conclusions exercise was graded more realistic on the hybrid (81% vs. In comparison with the VR simulator, the AR laparoscopic 44%, p=.007) and similar useful on both simulators (77% vs. simulator was regarded by all participants as a better simulator 72%). The dissection exercise was completed more often on for laparoscopic skills training on all tested features. the hybrid simulator (47% vs. 23%, p=0.002). Only the hybrid simulator was able to distinguish between advanced trainees and beginners, with significantly higher scores for all performance parameters for the latter. The hybrid simulator was graded more realistic (70% vs. 33%, p=.016) and more useful (83% vs. 62%, p=.12). Overall, acceptance of requirement to train on and to be evaluated by such simulators is still low (53% and 50%, respectively). Conclusion Fully computerized VR- or hybrid simulator performance parameters can distinguish between beginner and advanced trainees for perceptual motor skills (proving construct www.haptica.com | email: promis@haptica.com | tel (NAm) +617 342 7270 | tel (RoW) +353 (0) 1 676 7310
  • 6. Validation validity), but not for visuo-spatial exercises such as the camera __________________________________________ navigation. 10. __________________________________________ 11. SAGES 2006 Scientific Sessions S096 A COMPUTERIZED ANALYSIS OF ROBOTIC VERSUS LAPAROSCOPIC TASK PERFORMANCE 9. SAGES 2007: S077 V K Narula MD, W C Watson MD, S S Davis MD, K Hinshaw BS, COMPUTER-BASED LAPAROSCOPIC AND ROBOTIC SURGICAL B J Needleman MD, D J Mikami MD, J W Hazey MD, J H SIMULATORS: PERFORMANCE CHARACTERISTICS AND Winston MD, P Muscarella MD, M Rubin, V Patel MD, W S PERCEPTIONS OF NEW USERS Melvin MD, The Ohio State University. CMIS. Columbus, OH David W Lin MD, John R Romanelli MD, Renee E Thompson MD,Michael E Ganey MD, Ron W Bush BS, Neal E Seymour MD, Introduction Baystate Medical Center, Department of Surgery Robotic technology has been postulated to improve The expanding inventory of advanced surgical training devices performance in advanced surgical skills. We utilized a novel now includes simulators for laparoscopic and robotic surgery. In computerized assessment system to objectively describe the order to define perceptions of the need and value of such technical enhancement in task performance comparing devices, we evaluated the initial experience of surgeons using robotic and laparoscopic instrumentation. both in the course of performance of an advanced laparoscopic Methods and Procedures skill. Advanced laparoscopic surgeons (2- 10 yrs experience) Methods performed 3 unique task modules using laparoscopic and At the 2006 SAGES meeting, 62 Learning Center attendees evaluated a Telerobotic Surgical Instrumentation (Intuitive Surgical, new virtual reality (VR) robotic surgery simulator (RS) [SimSurgery, Oslo, Sunnyvale, CA). Performance was evaluated using a Norway] as well as either a computer-enhanced laparoscopic [ProMIS computerized assessment system (ProMIS, Dublin, Ireland) (PM), Haptica, Ltd, Dublin, Ireland] or a VR simulator [SurgicalSIM (SS), and results were recorded as time (sec), total path (mm) SimSurgery and METI, Inc, Sarasota, FL]. Demographic and training data and precision. Each surgeon had an initial training session were collected and all were assessed during one iteration of followed by two testing sessions for each module. A Paired laparoscopic suturing and knot-tying on RS and either PM or SS. An 8- Student’s T-Test was used to analyze the data. question survey was used to determine users? impressions of task Results realism, interface quality, and educational value (5-point Likert scale). Performance data [time, path length, smoothness (PM), errors (SS/RS)] 10 surgeons completed the study. Objective assessment of were collected and comparisons made between user-defined groups and the data is presented in the table below. 8/10 surgeons had different simulation platforms (Mann-Whitney Test, ANOVA). significant technical enhancement utilizing robotic technology Laparoscopic vs Robotic Time (sec) Total Results Path(mm) Precision Module 1210 vs 161 # 11649 vs 5571 * Task completion rate was greater for experts than nonexperts on all 1434 vs 933 * Module 2119 vs 68 * 5573 vs 1949 * 853 vs 406 * platforms (PM 100% vs 75%; SS 100% vs 36%; RS 93% vs 36%). Experts Module 377 vs 55 * 4488 vs 2390 * 552 vs 358 * # = p < 0.009 * performed better than nonexperts on all performance measures on PM = p<0.001 Conclusions: The ProMIS computerized assessment (p<0.05: time 154±16 vs 205±12; path length 820±97 vs 1287±97; system can be modified to objectively obtain task smoothness 952±111 vs 1582±127). There were no significant differences performance data with robotic instrumentation. All the between experts and nonexperts for SS and RS performance measures. tasks were performed faster and with more precision using Perception of value of haptic features was less for subjects with prior robot the robotic technology than standard laparoscopy. experience (n=10; p<0.05). Otherwise realism, interface quality, and educational value scores did not differ on the basis of prior simulator or robot use. Nonexperts found that robotic simulation better reflected clinical skill than did experts. Overall, subjective quality was scored higher for PM than for SS or RS. Conclusions The ability of performance metrics of the computer-enhanced simulator to discern predicted performance differences between experts and nonexperts was better than for VR devices with a single task iteration. Initial use of VR devices was associated with a lower overall perception of realism and educational value as compared to use of physical objects in the non-VR simulator. This may reflect the need for familiarization with the computer-generated environment before the educational potential of VR can be realized. www.haptica.com | email: promis@haptica.com | tel (NAm) +617 342 7270 | tel (RoW) +353 (0) 1 676 7310
  • 7. Validation 12. SAGES 2006 Education/Outcomes–P219 13. SAGES 2007: S080 INTEGRATING SIMULATION LAB TRAINING INTO A SURGICAL THE IMPACT OF KNOWLEDGE OF RESULTS IN SURGICAL RESIDENCY PROGRAM: IS VOLUNTARY PARTICIPATION SKILLS TRAINING EFFECTIVE A. O’Connor MD, C. Cao PhD, S. Schwaitzberg MD, Lily Chang MD, James Petros MD, Donald Hess MD, Caroline Department of Mechanical Engineering, Tufts University. Rotondi BA, Timothy Babineau MD, Boston Medical Center Background Objective Concerns about the adequacy of advanced laparoscopic Surgical training programs nationwide are struggling with the training continue to be raised despite a proliferation of integration of simulation training into their curriculum given the training systems exist. The manner in which the training constraints of the 80-hour work week. We examine the modules are structured to maximize learning has not been effectiveness of voluntary training in a simulation lab as part of examined. There are many aspects to the accumulation of the surgical curriculum. Methods: The ProMIS simulator was laparoscopic skills during training, one of which is introduced into the general surgery residency at Boston Knowledge of Results (KR), i.e. the information provided to University Medical Center. All categorical residents (28) were individuals about the outcomes of their motor responses in required to attend a 2-hour training session and curriculum their environment. We studied the effects of KR on the review. Non-categorical residents (23) were given the option to learning curve of laparoscopic suturing and knot tying. complete training. After the introductory session, time spent in Aims the lab was encouraged, but voluntary. Use of the simulator was tracked for all residents. Participation in the simulation We evaluated the learning curves of 9 medical students with curriculum was defined as 3 or more uses of the simulator. After no previous laparoscopic surgical experience under three 3 months, all residents completed a survey regarding the different conditions, each with different levels of simulation lab and their simulator usage. Results: 26 (93%) knowledge of results. categorical residents and 3 (6%) non-categorical residents completed the introductory simulator training session. Over a 3 Methods month period, use of the simulator at least once was 31% among Subjects were randomly assigned to one of three groups. all eligible residents; 80% of PGY1, 40% of PGY2, 60% of PGY3, Each subject attended a training session for 1 hour each and 0% of PGY4 and PGY5. Four residents (14%) participated in day, 6 days a week for 4 weeks. Group 1 (No feedback) the simulation curriculum. 71% of simulator usage was during received no knowledge of results (KR) and no performance working hours while 29% was completed post-call or off duty. feedback. Group 2 (feedback only) received factual KR Most residents agreed that the simulator was easy to use and following each training session, but no coaching. Group 3 improved their operative skills, but did not think it was a good (feedback and coaching) received KR and coaching. Learning substitute for actual operative experience. Reported reasons for curves were plotted based on task time, smoothness of not using the simulator included off-site rotation (44%), no time instruments and instrument’s path length. The task used (30%), and no interest (11%). was an intracorporeal suture/knot tying in the ProMIS laparoscopic simulator. Perceived workload for each session Conclusions was recorded using a standardized NASA TLX workload Voluntary use of a surgical simulation lab leads to minimal score. participation in a training curriculum. Participation should be mandatory if it is to be an effective part of a residency Results curriculum. The variability across each session for each student was calculated for each of the three parameters. There was statistical significance between the groups for all parameters (p-values 0.0002, 0.0002 and 0.009). Significant differences were found between groups 2 and 3 and group 1 (p values 0.0314-0.0410) Groups 2 and 3 learned significantly faster than those in Group 1, reaching performance plateaus at earlier sessions. There were no significant differences between groups 2 and 3 (p-values 0.1211, 0.1758 and 0.1375). Providing individuals with knowledge of results lowered their perceived workload, adding instructional feedback lowered this even further. These results demonstrate that KR is essential for efficient surgical skill acquisition. Individual coaching, a labor intensive proposition, reduces workload but has NO added beneficial effect on the speed of learning. These results www.haptica.com | email: promis@haptica.com | tel (NAm) +617 342 7270 | tel (RoW) +353 (0) 1 676 7310
  • 8. Validation provide a useful basis for developing efficient and cost effective 15. SAGES 2007 Education/Outcomes – P284 surgical skills training curriculum. ABSTRACT VIRTUAL REALITY TRAINING DEVELOPS CORE ____________________________________________________ LAPAROSCOPIC SKILLS COMPARABLE TO EXPERIENCED LAPAROSCOPIC SURGEONS: RESULTS OF A PROSPECTIVE 14. SAGES 2007: Education/Outcomes – P267 RANDOMIZED TRIAL COMPARING TWO VIRTUAL REALITY THE CONSTRUCT VALIDITY OF COMPUTER-DERIVED TRAINERS PERFORMANCE METRICS FOR SELECTED SIMULATED E. Matt Ritter MD, Elisabeth A Pimentel BA, Ryan E Earnest LAPAROSCOPIC TASKS BS, Randy S Haluck MD, Mark W Bowyer MD, National Capital J. A Oostema MD, Matthew Abdel BS, Jon C Gould MD, University Area Medical Simulation Center, Uniformed Services of Wisconsin School of Medicine and Public Health, Department University, Bethesda, Maryland / Department of Surgery, of Surgery Pennsylvania State College of Medicine, Hershey, Pennsylvania Introduction A surgical skills assessment tool is said to demonstrate evidence Introduction of construct validity if users with more experience, and by While simulation is becoming more widely accepted in inference more skill, perform better or more efficiently. surgical training, comparative trials on the training Computer derived motion metrics such as smoothness (the effectiveness of these simulators are lacking. We sought to number of times an instrument tip changes velocity during a compare the effectiveness of two abstract virtual reality task) and path length may be more sensitive measures of skill for trainers to train laparoscopic skills as assessed by the a particular task than traditional metrics such as time. Fundamentals of Laparoscopic Surgery (FLS). We then compared the post training performance of the novice Methods subjects with a group of experienced surgeons. Twenty-four medical students (third year), 19 surgical residents (PG1-5), and 3 attending surgeons were asked to perform four Methods and Results different tasks 3 times in a hybrid computer-based physical 20 novice medical students were recruited. Each subject laparoscopic trainer (ProMIS, Haptica Inc., Dublin). The 4 tasks in performed a pre-test consisting of 3 FLS tasks - Peg Transfer order of complexity were laparoscopic orientation (Task 1), (PT), Pattern Cut (PC) and Intracorporeal Suture (IS) - object positioning (Task 2), sharp dissection (Task 3), and intra- placed in the ProMIS augmented reality simulator (Haptica, corporeal knot tying (Task 4). Metrics recorded were time, path Ireland). They were then randomized to train to length, and smoothness. Laparoscopic operative experience for predetermined levels of proficiency on 3 tasks of the each user was quantified using case logs. Correlations were Minimally Invasive Surgical Trainer-Virtual Reality (MIST-VR) determined using regression analysis and ANOVA. (Mentice, Sweden) or the Rapid Fire/Smart Tutor (RFST) (Verefi, Elizabethtown, PA). After reaching the proficiency Results levels, both groups then took a post test consisting of 3 A statistically significant correlation was observed between trials of the same tasks used for the pre-test. Post test experience and performance for all three metrics for tasks 2-4 performance by both groups was then compared to a control (all p< 0.01). Smoothness was the only metric to correlate in the group, composed of 10 experienced surgeons who had laparoscopic orientation task. Within tasks, time and smoothness completed the same post test. correlate much more strongly with experience and to a similar MIST-VR and RFST groups demonstrated statistically degree. The strongest correlation was observed for the knot significant improvement from the pre-test to the post test tying task (r2=0.60 for time and 0.59 smoothness). An r2=1.0 on all 3 FLS tasks (p < 0.0001). There was no significant would represent a perfect correlation between experience and difference in post test performance between the MIST-VR the specified metric. and RFST groups. When the simulation trained groups were Conclusions compared to experienced controls there was no significant difference in performance with respect to PT. The The computer-derived metrics measured by the hybrid trainer experienced controls did significantly outperformed the correlate with laparoscopic experience. Further study is MIST-VR group in PC (p<0.01) and IS (p<0.05), but necessary to determine if specific metrics are better indicators differences between the experienced controls and the RFST of actual skill. group did not reach statistical significance. Conclusion Simulation based training on either the MISTVR or the RFST simulator improves the skill level of novices as assessed by FLS. The post training skill level of these novices compares favorably with a group of experienced surgeons. Virtual Reality trainers, such as RFST and MISTVR, train www.haptica.com | email: promis@haptica.com | tel (NAm) +617 342 7270 | tel (RoW) +353 (0) 1 676 7310
  • 9. Validation fundamental laparoscopic skills equally and to a level 17. SAGES 2006 Emerging Technologies P036 comparable to a group of experienced practicing surgeons. AUGMENTED REALITY SIMULATOR FOR HAND-ASSISTED ____________________________________________________ LAPAROSCOPIC COLECTOMY Derek Young, Derek Cassidy, Fiona Slevin, Donncha Ryan, Haptica Ltd, Dublin, Ireland. 16. SAGES07 Ergonomics/Instrumentation P307 Training in Hand-Assisted Laparoscopic Colectomy (HALC) A COMPUTERIZED ANALYSIS OF STANDARD VERSUS HIGH has largely been done using cadavers and porcine models. DEXTERITY LAPAROSCOPIC INSTRUMENTATION IN TASK These have drawbacks in terms of realism, logistics and lack PERFORMANCE of performance measurement. A Simulator would provide V K Narula MD,K M Reavis MD,D R Renton MD,D J Mikami MD,B J consistent instruction and practice and provide feedback on Needleman MD,J W Hazey MD,K E Hinshaw BS,W S Melvin MD, performance. However, given the range of instruments used THE OHIO STATE UNIVERSITY HOSPITAL, CENTER FOR MINIMALLY in the procedure, and especially the use of a hand, pure INVASIVE SURGERY virtual reality could not be considered as a solution. Introduction The ProMIS Augmented Reality simulator platform – by combining physical and virtual reality - enables interaction Minimally invasive surgery is becoming the standard of care for and tracking of real instruments with a physical model. And the majority of abdominal procedures. Laparoscopic because of its technological approach (vision-tracking) also instrumentation is constantly undergoing improvements to give enables the hand to be tracked. In the new ProMIS HALC surgeons an advantage. Articulated instrumentation provides a simulator, 3D models or graphical objects are overlaid on distinct advantage in the field of robotic surgery. Applying the the physical model to provide instruction and guidance. For same principles to standard laparoscopic instrumentation could example, a 3D animation may be used to demonstrate how offer increased degrees of freedom to make complex to complete a step; a graphical guideline ‘A – B’ may be laparoscopic tasks easier to perform. We utilized a novel used to indicate a target area for dissection. ProMIS HALC computerized assessment system to objectively evaluate task measures surgical skill by gathering data on the movement performance comparing Standard and High Dexterity (HD) of commercial laparoscopic instruments while completing a laparoscopic instrumentation. standardized task. The main performance metrics are time Methods taken, total path length and economy of movement. Additionally metrics specific to a step are calculated to Advanced laparoscopic surgeons (2-12yrs experience) performed measure performance associated with a specific instruction 3 unique task modules utilizing Standard and HD laparoscopic in a specific region of the physical model. Following the instrumentation (Novare Surgical Systems, Cupertino, CA). simulated procedure, the user completes a self-assessment Performance was evaluated using a computerized assessment which contributes to the metrics for the full procedure. A system (ProMIS, Dublin, Ireland) and results were recorded as full analysis is of performance is presented to the user on time (sec), path (mm), and precision. Each surgeon had an initial completion of the procedure and self-assessment. training session followed by two testing sessions for each module. A Paired Student’s T-Test was used to analyze the data. Results Results: Nine surgeons completed the study. Objective Initial trials of the ProMIS HALC simulator indicate that assessment of the data is presented in the table below. Module 1 practice on the simulator improves performance as was statistically significant, whereas Module 2 and 3 showed no measured by the metrics gathered by the simulator. While difference in task performance with the HD instrumentation. detailed validation studies remain to be done, initial Conclusion indicators are that the HALC simulator represents an “unparalleled opportunity to practice, step by step, a Hand- HD instrumentation is in its infancy. Results showed no assisted laparoscopic sigmoid resection” and “a huge step advantage using HD instrumentation. This could be due to the forward in surgical training”. learning curve associated with new instrumentation and technology. With future developments in HD technology and training, the user interface will improve and may offer an advantage over standard laparoscopic instrumentation. www.haptica.com | email: promis@haptica.com | tel (NAm) +617 342 7270 | tel (RoW) +353 (0) 1 676 7310
  • 10. Validation 18. May 2006 North of England Surgical Society Annual 19. EAES 2006, Poster Registrar’s Meeting Winner of the George Feggeter Gold Medal DEVELOPING PSYCHOMETRIC ASSESSMENT OF LAPAROSCOPIC SKILLS ACQUISITION: IS PSYCHOMETRIC LAPAROSCOPIC SKILLS USING THE PROMIS SIMULATOR MOTION ANALYSIS A VALID ASSESSMENT TOOL? Pellen MGC1;2, Barton JR2, Horgan LF1, Attwood SE1 1;2 2 1 1 Pellen MGC , Barton JR , Horgan LF , Attwood SE Northumbria Northumbria Upper Gastrointestinal Team of Surgeons1; Upper Gastrointestinal Team of Surgeons1; University of University of Newcastle upon Tyne2, United Kingdom Newcastle upon Tyne2, Newcastle upon Tyne, United Kingdom Aims Aims Reliable and validated methods of objective skills training In an evolving climate of competency-based assessment, reliable and assessment are required for trainee surgeons. The and validated methods of objective skills assessment are ProMIS Simulator (Haptica, Ireland) potentially offers a required for trainee surgeons. We aimed to assess whether the method of assessing laparoscopic psychomotor performance. ProMIS Simulator (Haptica, Dublin, Ireland) offers a method of We present initial data from our Centre and Royal College of assessing laparoscopic psychomotor performance. Surgeons Basic Surgical Skills (BSS) Courses. Methods Methods and results Volunteers comprising 17 experienced laparoscopists ( >100 Volunteers comprising 17 experienced laparoscopists (>100 laparoscopic cholecystectomies) and 38 medical students novices laparoscopic cholecystectomies) and 38 medical students (no laparoscopic experience) performed 3 simulated tasks novices (no laparoscopic experience) were assessed on a comprising virtual reality camera navigation, object transfer and complex sharp dissection task (glove over balloon). A sharp dissection task (glove over balloon). A further group of 28 further group of 28 basic surgical trainees (experience basic surgical trainees (experience limited to 1st assistant) limited to 1st assistant) attending BSS Courses were assessed attending BSS Courses were assessed on the same tasks before on the same task before and after training in laparoscopic and after training in laparoscopic skills. Data metrics of time, skills. Data metrics of time, smoothness and path length smoothness and path length were measured via optical tracking were measured via optical tracking of instrum-ent of instrument movement. Objective observations of specific movement as well as observations of specific errors. errors were also recorded. Data analysis (ANOVA) demonstrated experienced Results laparoscopists performed target dissection at least 50% faster, smoother and with more economy of instrument Non-parametric analysis demonstrated experienced movement than students (p<0.05). Experienced participants laparoscopists performed all 3 tasks significantly faster, performed sharp dissection more accurately (p<0.01) smoother and with more economy of movement (p<0.05), although no difference in balloon puncture frequency was excluding camera navigation path length. Experienced seen. Similarly significantly better performance over participants performed sharp dissection more accurately (p<0.01) trainees was demonstrated. Trainees showed only although no difference in balloon puncture was seen. Repeat significantly smoother instrument handling when compared assessment of BSS Course Trainees showed significant to students, possibly reflecting greater baseline dexterity in improvements in simulator metrics (Paired T test, P<0.05), this selective group. Repeat assessment following course although smaller yet significant improvements in “untrained” training showed significant improvements in all metrics by student performance was also seen. 32-40% (Paired T test, P<0.05). Whilst significant Conclusions improvements were also demonstrated in repeat assessment of the untrained student group, these were less marked (15- Gross analysis of these metrics can distinguish between 18%). experience levels supporting construct validity of these simulator tasks. These results suggest potential for objectively measuring Conclusions baseline skill level and response to training. Further work will The gross analysis of these metrics can distinguish between examine the effect of interface familiarisation and defining experience levels supporting the construct validity of this target levels of performance in simulated tasks. simulator task. These results suggest a potential role for objectively measuring baseline skill level and response to training in distinct psychomotor challenges. Further work in progress is examining the effect of interface familiarisation and repeated task performance on novice learning curves and defining target levels of performance in a range of simulated tasks. www.haptica.com | email: promis@haptica.com | tel (NAm) +617 342 7270 | tel (RoW) +353 (0) 1 676 7310
  • 11. Validation 20. Surg Endosc (May 2006) 20: 900–904 21. Surgical endoscopy ISSN: 0930-2794 (Paper) 1432- CONSTRUCT VALIDATION OF A NOVEL HYBRID SURGICAL 2218 (Online) SIMULATOR CONSTRUCT VALIDATION OF THE PROMIS SIMULATOR D. Broe, P. F. Ridgway, S. Johnson, S. Tierney, K. C. Conlon USING A NOVEL LAPAROSCOPIC SUTURING TASK Department of Surgery, Professorial Surgical Unit, Level 4, The K. R. Van Sickle1, D. A. McClusky III1, A. G. Gallagher and Adelaide and Meath Hospital, incorporating the National C. D. Smith1 Children’s Hospital, Tallaght, Dublin 24, Ireland Background Background The use of simulation for minimally invasive surgery (MIS) Simulated minimal access surgery has improved recently as both skills training has many advantages over current traditional a learning and assessment tool. The construct validation of a methods. One advantage of simulation is that it enables an novel simulator, ProMis, is described for use by residents in objective assessment of technical performance. The training. purpose of this study was to determine whether the ProMIS augmented reality simulator could objectively distinguish Methods between levels of performance skills on a complex ProMis is a surgical simulator that can design tasks in both virtual laparoscopic suturing task. and actual reality. A pilot group of surgical residents ranging Methodology from novice to expert completed three standardized tasks: orientation, dissection, and basic suturing. The tasks were tested Ten subjects — five laparoscopic experts and five for construct validity. Two experienced surgeons examined the laparoscopic novices — were assessed for baseline recorded tasks in a blinded fashion using an objective structured perceptual, visio-spatial, and psychomotor abilities using assessment of technical skills format (OSATS: task-specific validated tests. After three trials of a novel laparoscopic checklist and global rating score) as well as metrics delivered by suturing task were performed on the simulator, measures the simulator. for time, smoothness of movement, and path distance were analyzed for each trial. Accuracy and errors were evaluated Results separately by two blinded reviewers to an interrater The findings showed excellent interrater reliability (Cronbach_s reliability of >0.8. Comparisons of mean performance a of 0.88 for the checklist and 0.93 for the global rating). The measures were made between the two groups using a Mann- median scores in the experience groups were statistically Whitney U test. Internal consistency of ProMIS measures was different in both the global rating and the task-specific assessed with coefficient α. checklists (p < 0.05). The scores for the orientation task alone Results did not reach significance (p = 0.1), suggesting that modification is required before ProMis could be used in isolation as an The psychomotor performance of the experts was superior assessment tool. at baseline assessment (p < 0.001). On the laparoscopic suturing task, the experts performed significantly better Conclusions than the novices across all three trials (p < 0.001). They The three simulated tasks in combination are construct valid for performed the tasks between three and four times faster (p differentiating experience levels among surgeons in training. < 0.0001), had three times shorter instrument path length This hybrid simulator has potential added benefits of marrying (p < 0.0001), and had four times greater smoothness of the virtual with actual, and of combining simple box traits and instrument movement (p < 0.009). Experts also showed advanced virtual reality simulation. greater consistency in their performance, as demonstrated by SDs across all measures, which were four times smaller than the novice group. Observed internal consistency of ProMIS measures was high (α = 0.95, p < 0.00001). Conclusions Preliminary results of construct validation efforts of the ProMIS simulator show that it can distinguish between experts and novices and has promising psychometric properties. The attractive feature of ProMIS is that a wide variety of MIS tasks can be used to train and assess technical skills. www.haptica.com | email: promis@haptica.com | tel (NAm) +617 342 7270 | tel (RoW) +353 (0) 1 676 7310
  • 12. Validation 22. EAES 2004 Abstract nr.: O207 23. EAES 2004 abstract nr.: O208 RELATIONSHIP BETWEEN MOTION ANALYSIS, TIME, PSYCHOMOTOR SKILLS ASSESSMENT IN PRACTICING ACCURACY, AND ERRORS DURING PERFORMANCE OF A SURGEONS PERFORMING ADVANCED LAPAROSCOPIC LAPAROSCOPIC SUTURING TASK ON AN AUGMENTED REALITY PROCEDURES II: DEMOGRAPHICS AND PERFORMANCE SIMULATOR PROFILES Author: D.A.M. McClusky, Emory University School of Medicine, Author: A.G. Gallagher, Emory University, Atlanta, United Atlanta Georgia, United States of America. Co-author(s): K. Van States of America. Co-author(s): C.D. Smith, Emory Sickle, Emory University School of Medicine, Atlanta Georgia, University, Atlanta, United States of AmericaR.M. Satava, United States of America University of Washington, Seattle, United States of America A.G. Gallagher, Emory University School of Medicine, Atlanta Background Georgia, United States of America This study reports on the objectively assessed psychomotor Background performance of minimally invasive surgeons on a box-trainer Time, efficient movement, accuracy, and safety are reliable and and a virtual reality (VR) task as a function of handedness, discriminative metrics of proficiency during virtual reality and gender, sight corrected status, and age. Methods: Two box-trainer based minimally invasive surgical (MIS) training. The hundred and ten surgeons attending the 2001 annual role these metrics may serve during more advanced skills training meeting of the American College of Surgeons (ACS) in New are not well understood. Using a novel augmented reality Orleans who reported having completed more than 50 simulator, we sought to gain an understanding of the relationship laparoscopic procedures participated. Subjects completed a between these metrics during an advanced MIS suturing task. box-trainer laparoscopic cutting task and a similar virtual Methods: Eleven subjects completed 3 trials of a suturing task reality task twice. Demographic and laparoscopic designed for a box-trainer and adapted for the ProMIS (Haptica, experience data was also collected. Results: There were no Dublin, Ireland) simulator. Time, tool path, and smoothness of significant differences between subjects performance on movement were assessed using computer algorithms. Measures of either tasks in terms of handedness, gender or whether they accuracy during suture placement and errors in performance were sight corrected or not. A clear and consistent linear were assessed by two blinded reviewers trained to assess trend emerged in terms of age. Older subjects (ages 60 – 69) performance with inter-rater reliability > 0.8. A Pearson’s performed significantly worse than younger subjects (ages correlation coefficient was used to assess the strength of the 30 – 39, 40 – 49) on the box-trainer task for correct incisions relationship between ProMIS metrics and suturing task (13.1 Vs 19.3, p < 0.008) and incorrect incisions (12.3 Vs 2.5, performance. Results: Of the ProMIS metrics, time correlated p > 0.05). They also performed worse on the VR task for with tool path distance and smoothness of movement in three time (132 Vs 71, p < 0.05), error (99 Vs 41, p < 0.05) and trials (range 0.914 – 0.957, p < 0.0001). When the suturing task economy of movement (22.8 Vs 11.7, p < 0.05). Conclusions: was analyzed, accuracy and error score demonstrated an equally Increasing age was found to be associated with a decline in strong relationship (range -0.726 - -0.84, all p < 0.0001). objectively assessed psychomotor performance on two well Combining all metrics, path distance correlated strongest with validated laparoscopic tasks. accuracy (2 trials significant, range -0.67 - -0.93), and error Acknowledgements score (3 trials significant, range 0.54 – 0.61). Smoothness of movement significantly correlated with accuracy in 2 trials This study was supported with grants from the ACS, SAGES, (range -0.63 - -0.88), and time correlated with error score in 2 SLS, TATRC, and Emory University Endosurgery Unit. trials (range 0.56 – 0.60). Conclusion Metrics based on movement efficiency and time, and those based on task accuracy and error scores strongly correlate when grouped independently. At this time, a proficiency curriculum should incorporate both forms of analysis, however further validation work is needed to replicate these findings and give further insight into how ProMIS metrics relate to real-world performance. www.haptica.com | email: promis@haptica.com | tel (NAm) +617 342 7270 | tel (RoW) +353 (0) 1 676 7310
  • 13. Validation 24. JSLS, Journal of the Society of Laparoendoscopic 25. SAGES 2008 P174 Surgeons, Vol. 11, No. 3. (September 2007), pp. 273- FLS TEST IS TRANSFERABLE TO PROMIS SIMULATOR 302. Eric S Hungness MD, Albert Amini BA, Deb E Rooney MS, Eric CRITERION-BASED TRAINING WITH SURGICAL SIMULATORS: T Volckman MD, Nathaniel J Soper MD, Feinberg School of PROFICIENCY OF EXPERIENCED SURGEONS Medicine, Northwestern University, Chicago, IL Heinrichs, Wm, Lukoff, Brian, Youngblood, Patricia, Dev, Parvati, Introduction Shavelson, Richard, Hasson, M Harrith, Satava, M Richard, The McGill Inanimate System for Training and Evaluation Mcdougall, M Elspeth, Wetter, Paul Alan of Laparoscopic Skills (MISTELS) comprises five tasks with Objective an objective scoring system, and has been incorporated by SAGES in their Fundamentals of Laparoscopic Surgery In our effort to establish criterion-based skills training for (FLS) program. MISTELS has high inter-rater and test- surgeons, we assessed the performance of 17 experienced retest reliability and correlates with operative skill. laparoscopic surgeons on basic technical surgical skills recorded However, the FLS program is labor intensive, requiring a electronically in 26 modules selected in five commercially trained proctor. The ProMIS simulator allows for available, computer-based simulators. assessment of physical tasks (instrument path length and instrument smoothness) through instrument tracking Methods/Procedures technology. We hypothesized that the FLS scores obtained in the ProMIS simulator as well as ProMIS Performance data were derived from selected surgeons randomly metrics would correlate with standard FLS scoring. assigned to simulator stations, and practicing repetitively during three one-half day sessions on five different simulators. We Methods measured surgeon proficiency defined as efficient, error-free Twenty general surgery residents (13 junior and 7 senior) performance and developed proficiency score formulas for each had baseline laparoscopic skills assessed using MISTELS in module. Demographic and opinion data were also collected. the standard FLS and ProMIS simulators (pre-test). Nine junior and 4 senior residents had a post-test after four Results weeks of training. Tasks were scored by FLS and ProMIS metrics. Total path length (TP) and total smoothness (TS) Surgeons’ performance demonstrated a sharp learning curve with were calculated by adding the path lengths and the most performance improvement seen in early practice smoothness of each individual task. ANOVA was used to attempts. Median scores and performance levels at the 10th, compare the mean (SD) of total and individual task scores 25th, 75th, and 90th percentiles are provided for each module. for pre- and post-tests in the FLS and ProMIS simulators. Construct validity was examined for two modules by comparing Student's t-test was used to compare ProMIS metrics. experienced surgeons’ performance with that of a convenience Pearson's correlations were calculated for standard FLS sample of lessexperienced surgeons. scores in relation to ProMIS FLS scores, TP and TS. Significance was defined as p < 0.01. Conclusions Results A simple mathematical method for scoring performance is All residents showed statistically significant improvement in applicable to these simulators. Proficiency levels for training post-test total and individual task FLS scores on either the courses can now be specified objectively by residency directors FLS or ProMIS simulator. 100% and 88% of residents achieved and by professional organizations for different levels of training passing post-test scores on the FLS and ProMIS simulator, or post-training assessment of technical performance. But data compared to 30% and 29.2% on the pre-test. There was no users should be cautious due to the small sample size used in this difference in junior and senior resident posttest scores (87.6 study and the need for further study into the reliability and vs 79.1). ProMIS path length and smoothness were validity of the use of surgical simulators as assessment tools. significantly reduced across all tasks (range 14- 68%). Total ProMIS FLS scores (0.729), TP (-0.753) and TS (- 0.769) Summary comment significantly correlated with total standard FLS simulator The simulators used included pure Virtual Reality Simulators and scores. All residents with TP < 4000mm or TS < 6000 two simulators with real haptics (including ProMIS): Lap Mentor achieved a passing total FLS score. from Simbionix (pure Virtual Reality); LapSim from Surgical- Conclusions Science AB (pure Virtual Reality); SurgicalSIM from METI (pure Virtual Reality); ProMIS from Haptica (real haptics with metrics); All surgical residents achieved a passing FLS score after a LTS2000 ISM60 from RealSim (real haptics with metrics). 4-week laparoscopic skills curriculum. FLS tasks are transferable to the ProMIS simulator with traditional FLS ProMIS out-performed the virtual reality simulators with a mean scoring and intrinsic ProMIS metrics being good effectiveness rating of 3.56 versus 3.22 and 3.11 for LapSim and measurement tools. A ProMIS total path length <4000 mm SurgicalSim (LapMentor also scored 3.56). or total smoothness <6000 reliably predicts a passing FLS score. www.haptica.com | email: promis@haptica.com | tel (NAm) +617 342 7270 | tel (RoW) +353 (0) 1 676 7310