by: Christopher Simmonds, VP Business Development & Marketing, Mimic Technologies
While Mimic has been actively focused on simulation for robotic surgery over the past 15 years, I thought it would be interesting to see how simulation was valued for medical training, in general. While trawling through the internet I came across a study published by the Association of American Medical Colleges (AAMC) in 2011. The survey was sponsored by a number of other societies including: IMSH, ASPE and AACN. While it is five years old, I do believe it probably still holds true.
The questionnaire was sent to 133 AAMC member medical schools and 263 teaching hospitals in January through March of 2010. It is interesting to note that the use of simulation increased over time with medical students in both medical school or a teaching hospital environment. While with residents the reverse pattern was seen to occur with more simulation taking place in the first years of residency than in the later years.
These observations reflect what we have seen in many of the teaching hospitals using Mimic’s dV-Trainer. Residents are asked to develop psychomotor skills on the simulator before being allowed to migrate to the OR. Many institutions set a specific curriculum with proficiency levels that must be attained before the resident can sit down on the real robotic surgery console and start performing only very specific steps of a procedure.
An interesting part of this AAMC survey looked at how simulation is being used for education and assessment as well as part of a quality improvement program. What sparked my interest was the fact that the researchers differentiated between a number of skills that are very important to Mimic, such as psychomotor skills in addition to clinical thinking/decision making, team training and interpersonal communication skills.
Teaching hospitals were asked to indicate how simulation is used across the three domains of education, assessment, and quality improvement or research. All 64 respondents answered this question. Similar to medical schools, overall responses demonstrate simulation is largely used for educational purposes at 87 percent average usage across all competencies, less so for assessment at 61 percent, and much less frequently for quality improvement and research at only 34 percent.
Teaching Hospital Use of Simulation by selected areas:
In online questionnaires carried out by Mimic Technologies, we were able to see that over 90% of robotic surgeons had used Mimic simulation products either on Mimic’s dV-Trainer or on the da Vinici® Skills Simulator. This simulation training was primarily for the development of psychomotor skills as part of the surgeons’ initial training on robotics. In our experience fewer hospitals are using simulation for assessment, though we do know of some residency programs who include simulation in their recruitment process. We are also aware of institutions that have implemented a short curriculum that all surgeons need to pass annually to prove that they have the maintained their skill level for the surgical robot.
When it comes to quality improvement the picture is less clear. Given surgeons’ the time constraints, very few hospitals have initiated QI programs that leverage simulation to help improve the skill sets of lower performing surgeons.
As mentioned previously, this paper is five years old and I am sure the situation has continued to evolve. The implementation of the affordable care act is shining a spot light on patient outcomes and thus indirectly on variations in surgical performance. We can see that many institutions are trying to see how they can help improve the outcomes of their lower performers and we believe simulation will have a key role to play.
The gold standard treatment option for men under 70 with early-stage, organ-confined cancer is surgical removal of the prostate using nerve-sparing radical prostatectomy. Since its introduction, surgical robotics has achieved widespread acceptance for performing radical prostatectomies in both the United States and Europe, and is increasing in adoption worldwide. In the U.S., robotic-assisted radical prostatectomy (RARP) is now the most common treatment for localized prostate cancer. Faster operating times, less blood loss, fewer complications, and shorter hospital stays are just a few of the reasons for its popularity among both patients and surgeons. In the coming years, it is anticipated that relative case volumes for the surgical robots will grow significantly as newer robotic systems are added or replaced in hospitals worldwide.
There is a debate going on currently about the importance of simulated procedural training and the best way to approach it. One approach is to have a complete virtual reality environment where students can “play “at learning the procedure and carry out any task they wish. A second way of learning, which Mimic believes works best is to learn from industry leading surgeons/proctors who can guide students through their own approaches and challenge the learner’s knowledge acquisition. This learning process is then augmented by specific virtual reality tasks that are key parts of the procedure to develop critical psychomotor skills.
There are currently no studies that have been carried out that have been able to validate either approach to procedural training. This is partly due to the recognition that the technology is still not fully advanced enough to simulate the complexity of human tissue and surgical interaction and include all the myriad of potential outcomes as surgeons learn through trial and error.
Clinical societies such as EAU have published guidelines for a structured training program and curriculum for teaching surgeons how to perform a RARP (see European Urology, August 2015, Volume 68, Issue 2, Pages 292–299). Although there is wide acceptance for key steps and strategies for the procedure, differences between cases (e.g. patient considerations, cancer location, desire for neurovascular bundle preservation, need for sentinel lymph node dissection, etc.), differences between robotic platforms (e.g. Xi vs Si), and surgeon preference or experience may warrant some variations in the surgical strategy. For this reason, Mimic has decided to simultaneously release two versions of their Maestro ARTM RARP training curricula. One has been developed based on the da Vinci® Si platform with Dr. Henk Van der Poel (filmed at the Netherlands Cancer Institute, Amsterdam, The Netherlands); the other is based on the da Vinci® Xi platform with Dr. Vip Patel (filmed at Florida Hospital, Orlando, FL, USA).
Both procedures offer a complete training solution for RARP, from initial patient and robot setup, to the final urethrovesical anastomosis. Each Maestro ARTM training curriculum integrates high definition 3D video footage from an actual RARP (narrated by the surgeon who performed the case) with augmented reality interactive tasks such as recognition of key anatomical structures, identification of surgical planes and landmarks, energy application, tissue retraction, and multiple choice questions. Additionally, each Maestro curriculum includes a set of virtual reality exercises selected by the surgeon and designed to teach specific robotic skills that are important at the various stages of the procedure.
The table below highlights the variation between the two curricula:
Although the major steps of the procedures are the same, the Si and Xi versions of the Mimic Maestro ARTM RARP curricula are differentiated at several key moments. These include: the location and technique for the initial peritoneal dissection and entry into the Space of Retzius, the timing and suturing technique used to ligate the Dorsal Venous Complex, the approach for the dissection of the posterior bladder neck and seminal vesicles, the strategy used during the preservation of the neurovascular bundle, and the type of suture and technique for the posterior reconstruction (Rocco stitch) and urethrovesical anastomosis.
Additionally, the Xi module highlights a new feature giving the surgeon the ability to rotate a 30 degree endoscope from a 30-down view to a 30-up view with the push of a button in order to gain greater visualization beneath the prostate during posterior dissection. Ultimately, the different styles, teaching preferences, and words of wisdom from our two surgeon collaborators offer a complete and well-rounded training pathway for any surgeon wanting to learn best practices for RARP on either robotic platform.
A Case Study of the BAUS Audit on Prostatectomy
Recently, there has been ongoing debate around the impact of case volumes on surgical outcomes. A previous blog post (The Cost Debate in Robotic Surgery and the Impact of Skills) discussed a 2013 study published in the New England Journal of Medicine by Dr. John Birkmeyer, et al, which looked at skill levels between surgeons and identified that surgeons in the lower quartile completed three times fewer operations compared to surgeons in the top quartile.
In December 2012, the UK Government outlined plans to publish surgeon-level outcomes data, taken from national clinical audits, in ten specialty areas, which included Urology. This is known as the Consultant Outcomes Publication (COP) programme.
The British Association of Urological Surgeons (BAUS) has since published a number of audits on surgical outcomes in areas such as Prostatectomy, Nephrectomy, Stress Urinary Incontinence, and Urethroplasty. These audits are available for the general public to review the volumes and outcomes of a wide variety of surgeons.
The 2015 Prostatectomy audit, which looked at 2014 cases was published in September 2015 and the results are summarized below (as published on the BAUS website).
- The data collection period was from January 1, 2014 to December 31, 2014
- 6,161 cases were submitted in total, of which 5,814 were from England; these 5,814 cases came from 147 consultants at 62 sites, and include 230 private patients from 37 consultants
- Hospital Episode Statistics (HES) for 2014 indicate that there were 6,651 radical prostatectomies undertaken in England, so data was collected from 87% of the radical prostatectomies undertaken in England in 2014
- 5% were robotic assisted, 26.7% laparoscopic, 13.4% open and in 1.4% of cases the technique was not recorded
- Median number of cases per consultant: 32 (range 1 – 157)
- Median number of cases per center: 85 (range 1 – 250)
- The overall transfusion rate was 7% – for England only, 2.6%. In England only, the transfusion rates by technique were: open 5.4%, laparoscopic 0.8% and robotic 2.9%.
- 5,174 of the entries recorded whether there had been adverse events. The total post-operative complication rate was 5% (491 / 5174). Of these 491 cases, 364 recorded the Clavien Dindo grade (i.e. 127 or 26% did not). Complications classified as Clavien Dindo Grade III or above were seen in 1.6% of cases.
“Another interesting point to note was that there were differences in surgical positive margin rate between the three approaches,“ says Mr. Ben Challacombe MS FRCS (Urol) Consultant Urological Surgeon & Honorary Senior Lecturer, Guy’s Hospital & King’s College London. “Robotic surgery had an average of 13% while both the open and Laparoscopic approaches were at 19%. The length of stay was also seen to be lower for the robotic approach at a median of one day post operative”
We decided to go into each of the individual surgeons recorded on the web site and try and see if we could give any further insight into volumes carried out by the differing surgeons. Given that 12% of the cases do not have complications rate reported I did not try and see of there was a linkage between volume and complications due to the incompleteness of the data set available.
There were a number of interesting patterns.
Volume by procedural type:
As the table shows, more surgeons did Robotic cases and on average did more cases per year than the other approaches. We therefore decided to an analysis of the difference in procedures between the top and bottom quartile. A quartile was based on the number of surgeons doing the procedures so for example in the robotic cohort we compared the volume of the top 21 surgeons against the bottom 21 Surgeons.
The table below highlights the differences:
25% of the surgeons (37) with the highest volumes carried out over 50% of the cases. Interestingly the concentration was greatest in Open surgery where they carried out 69% of the cases. At the other end of the spectrum 37 surgeons with the lowest volumes only did just below 9 cases each or 5% of the total volume.
This picture is made slightly more complicated as clearly some surgeons will do more than one technique. In this sample 106 of the surgeons (73%) used only on technique while 36 used two techniques and three surgeons used all three techniques.
The overall surgical volumes increased as the number of techniques used increased. Those using one technique averaged 39 cases in the time period, those using 2 averaged 45 and those using 3 averaged 49 procedures. It is only natural that this occurs as surgeons move from one technique to another or believe that different patients are better suited to different techniques.
One of the big advantages of the 21st century is that data from surgical performance is becoming more transparent. This transparency is going to allow medical professionals to have visibility on a number of factors that affect patient outcomes, which will allow them to put in the correct protocols to ensure that the highest quality of care is always delivered. We believe that the increasing amount of data is showing that the use of validated simulation protocols and curriculum can ensure best results for patients.
On November 13, 2015, a panel of experts in robotic surgery met at the Académie Nationale de Chirurgie (ANC) in Paris to discuss training in robotic surgery. The meeting was moderated by Professor Michel Huguier and the speakers included:
- Professor Rolland Parc, Conseil de l’Ordre des Médecins
- Professor Jacques Marescaux of IRCAD (the institute for research into cancer of the digestive system), Strasbourg
- Professors Jacques Hubert and Laurent Bresler of the School of Surgery at Nancy
- Professors Xavier Cathelineau and Guy Vallancien of the École Européenne de Chirurgie (European surgical training centre), Paris
- Professor Jacques Belghiti from the HAS (the French national health authority)
- Dr Denis de Valmont from the insurance company SHAM
- Dr Yves Allioux of the Caisse Nationale d’Assurance Maladie (CNAM)
The full day session included discussions and presentations on the current status of robotic training in France as well as an overview of the adoption and current state of robotic surgery in a number of key specialties from Urology to Thoracic.
Their group identified some fundamental needs:
- Training requirements should be based on the established protocols for training in surgical robotics (drawn up by the teams from Nancy, France)
- It is essential to anticipate the arrival of new robotic platform
- It would not be helpful to increase the number of training centers. What is required would be several centers of excellence who are well equipped in platforms and personnel, with good reporting systems or registers.
The guiding principles of modern computer-assisted surgery, and thus of robotic surgery, should be the following:
- It is assumed that the clinicians should know how to operate and be competent in their surgical specialty
- Surgeons need to become familiar with the all aspects of the computer-assisted system
- Success will only be achieved through partnership with the manufacturers
- However, maintaining professional ethics and independence and avoiding all conflicts of interest is essential
- Being able to justify scientifically the evolution of treatment approaches thus being able to satisfy financial policymakers, and to defend surgeons against whom the HAS starts disciplinary proceedings.
Conclusions from the discussions:
The training in robotic surgery currently provided by the manufacturers is not a legally binding qualification. Their only obligation, as with any equipment manufacturer, is to explain to the purchaser how their product works. This training, according to published literature, is generally too short, and does not include any assessment of surgeons’ ability to use these robot systems. The responsibility of monitoring this training should, therefore, fall to the scientific societies and the universities in partnership with the manufacturers, and should include the evaluation of teams who will be tasked with these, using these new technologies. Training in robotic surgery can be provided by both public or private institutions, bearing in mind that it requires a substantial investment in equipment. It appears that university budgets alone will not be enough to meet this investment, and that public institutions could enter into partnerships with the private sector to meet the demand.
Robotic surgery is put into practice by surgeons and their teams, and their training should cover 5 areas:
1 – Surgical training is the remit of the existing schools of surgery
2 – Basic training in the use of a “robot” is common to all specialties that plan to use the system. It should be validated by a document certifying that the surgeon attended a course of basic training involving learning about the machine and the relevant techniques, with time on a simulator and on the robot in “dry lab” and “wet lab”. This stage of training should finish with an assessment
3 – In robotic surgery the surgeon is removed from the operative field, and there is, therefore, a loss of visual communication with the rest of the team. This makes training of the other members of the surgical team (team training) indispensable
4 – The clinical training specific to each specialty and procedure will be carried out in centers that have robots and having “proctors” (“Advanced Courses”)
5 – Surgical practice involves lifelong learning, which requires that the surgeon maintain his skills throughout his or her career. The question of re-certification, like that imposed on aircraft pilots following a period of inactivity or when they don’t practice their skills on a regular basis, does not currently exist in medicine. It is likely that in future the development of simulators will enable surgeons in these situations to refresh or maintain their technical skills.
Growing in popularity, robotic surgery is still not without challenges. Before the benefits of robotic surgery can be fully realized, the highest level of patient safety must be ensured, while remaining cost effective and at the same time allowing new surgeons the ability to be trained and access the technology without impacting safety and cost-effectiveness.
The Halstedian Method of “see one, do one, teach one” is clearly no longer sufficient for surgical training. Many comparisons between the training of pilots and the training of surgeons have been made over the years. In 2013, the FAA updated their rules to state that to be qualified as a First Officer, a pilot needed 1,500 hours total time. This includes both real and approved simulation time. Looking at a typical Resident training program, the calculations for a general residency that will last 4 years is approximately 16,600 hours. If within this a surgical trainee chose to focus on Gynecology for 20 months they would receive 6,400 specialty hours. If a surgeon focused on minimally invasive surgery, such as robotics, the Accreditation Council for Graduate Medical Education (ACGME) guidelines recommend 105 hours exposure to a variety of cases. Even tripling this minimum, a surgeon would be only at 300 hours of surgery, which is only a fraction of the 1,500 hours the FAA recommended training time for pilots.
Just as in aviation, simulation has been seen to be a solution allowing surgeons to develop their skills without impacting patient safety. Mimic’s MSim software, found on both the dV-Trainer and the da Vinci Skills Simulator, has been one of the most researched and validated simulation software in the surgical field. Table 1 below shows the range of validation studies that have been carried out on either platform as well as other simulators.
The studies, and in a particular the predictive validity study looking at simulation and operative outcomes, carried out by Dr. Culligan, have helped shape recommendations for surgical training being developed by medical societies such as those developed by the American Association of Gynecologic Laparoscopists (AAGL) in 2014.
All of these studies and simulation programs focused on the psychomotor component of learning how to “drive the robot” and not necessarily the cognitive training requirements that would help train the next generation of surgeons. Augmented reality was developed under the Maestro AR name to help solve this issue. It is best to think of Maestro AR as a curriculum incorporating both psychomotor tasks and cognitive questions supported by a moderated guide on a procedural approach and technique.
The basic premise is that a student will learn more if the psychomotor skills that they require are placed within their procedural context as opposed to in a vacuum. As students are learning how to use the robotic device they are also being tested on tissue recognition, procedural choreography, as well as learning from the narration about the decision making process behind this specific approach.
The Benign Hysterectomy Maestro AR module, for example, is divided into 9 modules starting with a Pelvic Anatomy survey and working through clear steps on how to deal with the ligaments and uterine vasculature before finishing with the Colpotomy and the Vaginal Cuff Closure.
“Maestro AR addresses the next frontier of training by developing a pathway that incorporates Didactics with Augmented Reality through virtual reality simulation,” says Mireille Truong, Virginia Commonwealth University Medical Center, “I am confident that research will show that adding didactic elements to simulation training will continue to improve surgeon performance when they enter the OR.”
As with the airline industry, simulation is becoming a vital part of the armarmentarium required for surgeons to ensure that through all stages of their career, they have the correct level of skills for the task ahead of them. Just as pilot is able to land a plane in virtually any airport around the world on their simulator, it is hoped that surgeons will also be able to develop their skills within a procedural scenario in an augmented reality environment.