Surgeon Skill and Patient Outcomes: Are they linked and can they be improved?

Transcription

1 Hepatobiliary (HPB) surgery is a low volume, highly complex specialty associated with high rates of morbidity and long learning curves necessary to achieve optimal outcomes. 1-3 Recent randomized controlled trials have reported peri- operative mortality as high as 12% 4 and post- operative morbidity as high as 91% 5 for the pancreaticoduodenectomy (PD). In efforts to improve outcomes following this procedure, an International Study Group formed to standardize reporting of common post- operative complications due to their frequent occurrence: post- operative pancreatic fistula (POPF=21.9%), delayed gastric emptying (DGE=22.8%), and post- pancreatic hemorrhage (PPH=5.9%). 6-9 These administrative database reviews, while providing an improved understanding, are still very limited, and considerable heterogeneity exists between individual patient outcomes and surgeon performance in these risk- stratifying scoring systems. A provocative and novel study recently suggested that intraoperative technical proficiency might be one of the most important determinants of surgical outcomes. 10 In this landmark study, Birkmeyer et al identified superior surgical skill to be strongly associated with improved patient outcomes. 10 Surgeons with the highest skill ratings had higher volume, and lower operative times compared with surgeons with the lowest skill ratings. This profound study suggests that efforts to improve surgeon proficiency are an important, yet understudied, aspect of health service outcomes research. The number of cases necessary to achieve surgical proficiency and optimal operative outcomes ( learning curve ) for the PD has been reported to be more than 70 cases. 1-3 As early adopters of the minimally invasive robotic platform in HPB surgery, 11,12 our institution has performed over 700 complex robotic HPB cases and described a learning curve similar to previously described for complex open pancreas resections. 13,14 These data are quite daunting when one considers that the average number of these procedures that fellowship trained HPB surgeons will encounter is half of the predicted learning curve. In fact, reported average surgical volumes predict that most surgeons require between 5 and 10 years to reach optimal surgical proficiency and outcomes. 1-3 Given this, a better approach to training and assessing surgeon performance in these techniques is a critical national public health issue. Ideally, a structured training curriculum that maximizes surgeon preparedness outside of the operating room will more efficiently allow surgeons to attain operative proficiency (and optimal outcomes); however, one currently does not exist. 15 The MIS robotic platform is an ideal paradigm to test these notions given the availability of simulators, inanimate training systems and the nearly universal video recording of cases. We hypothesize that surgical performance during the PD, specifically performance of the critical pancreaticojejunostomy (PJ) and gastrojejunostomy (GJ) anastomoses will correlate with surgical outcomes, and that training novice surgeons by utilizing a proficiency- based biotissue curriculum can improve robotic surgical skill. To investigate this hypothesis, the objectives of this 2- year proposal are as follows: Objective 1 Evaluate video of robotic PJ to determine whether technical skill scoring will correlate with primary clinical outcome of POPF. Objective 2 Evaluate video of robotic GJ to determine whether technical skill scoring will correlate with primary clinical outcome of DGE. Objective 3 Determine whether robotic surgical skill can be improved to proficiency using biotissue models of robotic pancreaticoduodenectomy anastomoses: PJ and GJ. 1

2 Background Classic surgical pedagogy has been see one, do one, teach one. Many factors have occurred in parallel over the last two decades: 1) more oversight and work hour restrictions from the ACGME; 2) rapid expansion of technology, most notably MIS; 3) increase in fellowship training positions in general surgery disciplines; and 4) an increasingly litigious society. This has led to decreased exposure, experience, and mentorship in a climate of increased scrutiny. 15 As surgical technology advances, training programs need to advance as well. To this end, surgical coaching strategies have been designed and implemented for practicing surgeons. 16 Simulation is an innovative training tool that has been successfully integrated to establish quality and safety in the airline industry and is readily available for robotic surgery. 17,18 Multiple studies have demonstrated the effectiveness of robotic simulators; however, there is a current need for implementation and evaluation of a training program to look at content and predictive validity for translating robotic skills to surgical proficiency and outcomes. Our group has the most experience in the world with robotic pancreas surgery and we have recently developed a proficiency based robotic surgery curriculum for our trainees that focus on robotic technical skills (see Appendix A - Figure 1). Preliminary Studies Step #1 Simulation Curriculum. A mastery- based simulation curriculum was performed in a virtual reality environment. A pretest/posttest experimental design utilized virtual reality tasks and inanimate tasks to evaluate technical improvement. Scores from virtual reality tasks were downloaded directly from the simulator; maximum of 100 per drill. Scoring of inanimate tasks was done based on video analysis by two graders; maximum of 30 per drill. 10,19 When the tests in their entirety were analyzed as a group using signed- rank test, the post- tests showed dramatic improvement over the pre- tests (p < ). This held true for most individual testing tasks as well (Figure 2). All scoring parameters were ranked and converted to quartiles, which were analyzed into two categories: testing and curriculum. Fellows with quartiles 4&4 or 3&4 were classified as High performers, quartiles 2&2, 2&3 or 3&3 were Moderate performers, and 1&1 or 1&2 were classified as Low performers (Figure 3). Step #2 Biotissue Curriculum. Deliberate practice models mimicking the exact technical PJ, GJ, and hepaticojejunostomy (HJ) anastomoses were created using bioartificial organs (Lifelike BioTissue; Ontario, Canada). These were performed by attendings to create a gold standard. All biotissue drills were graded by two HPB surgeons according to three factors (Figure 4): A) time for completion [lower better], B) number of errors (needle drops, torn material, air- knots, torn suture, etc.)[lower better], and C) Birkmeyer (modified OSATS) [higher better; 30 max]. 10 Average time, errors, and Birkmeyer show a trend for improvement, as a group, with each subsequent attempt (1 st through 5 th ), but have not reached the average score of the attendings. Each individual fellow s attempts were analyzed, as was the variation between fellows in each attempt. In Figure 5: A) depicts a fellow s HJ times showing linear improvement with subsequent drills, B) depicts a waterfall plot illustrating each fellow s first GJ time; showing a range from 52 to 94 minutes, and C) depicts a fellow s PJ times without appreciable trend with subsequent attempts. After the fifth attempt, surgical coaching was performed on each fellow s anastomoses to identify any problems and provide direct feedback. 2

3 Research Design Objective 1 Evaluate video of robotic PJ to determine whether technical skill scoring will correlate with primary clinical outcome of POPF. We currently have: 1) a large video library which includes hundreds of robotic PD broken down into steps, with time, qualitative data, and surgeon information: a) mobilization, b) porta hepatis, c) uncinate process, d) cholecystectomy, e) PJ (median time = 35 minutes; range 20 53), f) HJ (median time = 26 minutes; range 11 41), and g) GJ (median time = 46 minutes; range 15 85) and 2) a robust, prospectively maintained database of operative outcomes from these cases. In this aim, we will perform video analysis of the PJs and correlate with POPF development and other markers of surgical outcomes. The grading analysis will be a compilation of scoring; in addition to the methods used be Birkmeyer et al. 10 This compilation will include: visual cues related to tissue, robotic specific metrics, a cumulative scored analysis of each individual step, and an overall gestalt (see Appendix B). Additionally, fellows submit self- evaluations and logs of steps performed on all robotic cases. In addition to correlating surgical skill with patient outcomes, data will be analyzed by multivariate analysis attending vs. fellow, simulation testing quartiles, simulation curriculum quartiles, biotissue quartiles, previous number of PJs performed, and their relation to technical skill scoring. Objective 2 Evaluate video of robotic GJ to determine whether technical skill scoring will correlate with primary clinical outcome of DGE. Same as Objective 1, except with GJ. Objective 3 Determine whether robotic surgical skill can be improved to proficiency using biotissue models of robotic pancreaticoduodenectomy anastomoses: PJ and GJ. Each individual fellow will continue to perform biotissue modules until they achieve proficiency, defined as within 1 standard deviation of the attendings time, errors, and Birkmeyer score. The group will be analyzed according to the % able to reach proficiency and average attempts to proficiency in the three domains. Additionally, on an individual basis, raw scores will be analyzed and converted into ranks. Fellows will be then placed in quartiles based on time, errors, Birkmeyer, and each individual anastomoses. Corollary studies will be performed between the biotissue quartiles and the previous testing and curriculum quartiles to look for an association. Summary / Measurable Deliverables At the conclusion of this project we will, for the first time, have data directly correlating a surgeon s technical performance on specific operative tasks and patient outcomes following pancreaticoduodenectomy. We will have a validated simulation based curriculum in robotic HPB skills that measures and rates a trainee s technical performance. 3

4 APPENDIX A 4

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6 APPENDIX B Case Grader Difficulty of Pancreaticojejunostomy Classes = Leak Risk 1. Ergonomic set- up of robot/camera: Poor Average Good 2. Gland texture: Soft Hard Friable Combination 3. Duct size: mm Tiny Small Average Large 4. Overall: Low Risk Average Risk High Risk Birkmeyer Scoring: 5- point operating scale 1= General Surgery Chief Resident, 3=Average Robotic Surgeon, 5=Master Robotic Surgeon 1. Gentleness: Gentle tissue handling that does not result in injury 2. Time and Motion: Economy of motion, maximum efficiency 3. Instrument Handling: Fluid us of instruments without awkwardness 4. Flow of Operation: Smooth transitions from one part of the operation to another 5. Tissue Exposure: Retraction that allows for good visualization and proper tissue alignment 6. Summary Score: Overall assessment of technical skill Robotic Skills Scoring: 5- point rating scale 1=poor execution, 2=lacks finesse, 3=average, 4=skilled/efficient, 5=flawless 1. Instrument Collisions Never Rarely Often Frequently Always 2. Instruments Out of View Never Rarely Often Frequently Always 3. Excessive Instrument Force Never Rarely Often Frequently Always 4. Needle Loading Consider: angles, re- loads, handedness, economy, etc. 5. Dropped Needles, etc. Never Rarely Often Frequently Always 6. Missed Targets Never Rarely Often Frequently Always 7. Broken Sutures Never Rarely Often Frequently Always 8. Knot Tying Consider: fluidity, granny knots, square knots, sliding knots, tail length, etc. 9. Master of Workspace Range Consider: movement across field, camera adjustment, fluidity of transitions, etc. 6

7 Technical Scoring Pancreaticojejunostomy: 5 point rating scale 1=traumatic, 2=lacks finesse, 3=average, 4=skilled/efficient, 5=flawless 1. Setting up small bowel 2. Finding duct & placement of PD stent 3. Placement of Superior 2- O silk 4. Placement of Duct U stitch 2- O silk 5. Placement of Inferior 2- O silk stitch 6. Knot tying of Superior 2- O silk 7. Knot tying of Duct U stitch 2- O silk 8. Knot tying of Inferior 2- O silk stitch 9. SB Enterotomy 10. Placement of Posterior Superior 5- O polysorb 11. Placement of Posterior Inferior 5- O polysorb 12. Knot tying of Posterior Superior 5- O polysorb 13. Knot tying of Posterior Inferior 5- O polysorb 14. Placement of PD stent in bowel 15. Placement of Anterior Superior 5- O polysorb 16. Placement of Anterior Middle 5- O polysorb 17. Placement of Anterior Inferior 5- O polysorb 18. Knot tying of Anterior Superior 5- O polysorb 19. Knot tying of Anterior Middle 5- O polysorb 20. Knot tying of Anterior Inferior 5- O polysorb 21. Buttress of Superior 2- O silk 22. Buttress of Duct U stitch 2- O silk 23. Buttress of Inferior 2- O silk stitch Total Time of PJ Pancreatic Fistula Prediction Classes = 1, 2, or 3 Why? 1. I think this leaks 2. I do not agree or disagree with a leak 3. I do not think this leaks Comments? 7

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