“Mapping and Comparing Brain Activation in Surgeons using fMRI to Improve Surgical Performance”

Statement of Funds: No other funds are available or pending at this time for this study. Summary and Scientific Merit: To better understand the neurodynamic changes that mediate execution of surgical procedures and to improve strategies that increase psychomotor performance in high pressure situations, we propose to map and compare brain activity at rest and while answering multiple choice questions of a surgical procedure in an MRI – pre and post curricular intervention. See Table 1. Specific Aims: This study will enhance our understanding of cognitive organization while performing a procedure through: a) analysis of brain activation in an MRI b) correlation of brain activation with other subjects c) analysis of curricular intervention based on brain activation data and procedural outcomes of experimental and control subjects. Impact: Increased understanding of intra-operative cognitive organization will lead to the development of a curriculum that increases learning, memory, and surgical performance – Because learning, memory, and surgical performance are psychophysiological processes, in order to be enhanced, they require psychophysiological strategies (self-regulation and video-based guided imagery) so the right care happens at the right time when seconds count. According to the listing of funded studies on the SAGES website, this research has not been funded and the need to improve learning and surgical performance rates very highly in the article referenced on the SAGES website that was published in Surgical Endoscopy in 2007: A Research Agenda for Gastrointestinal and Endoscopic Surgery. Objectives and Benchmarks: In order to better understand intra-operative cognitive organization, the following objectives and benchmarks will be accomplished within a one year time frame: 1) During phase one, five experimental subjects and five control subjects will have their brain

activation patterns recorded in an MRI while solving questions related to a laparoscopic cholecystectomy. They will also complete that same procedure on a simulator in the Duke Surgical Education and Activities Lab.

2) The psychophysiological curricular intervention will be developed on an individual basis for experimental subjects – it will be derived from the subjects’ debriefing. Control subjects will be given materials to read on the procedure.

3) In phase two, the subjects will follow the same protocol as in phase one. 4) Brain activation patterns and performance scores will be analyzed pre and post curricular

intervention. 5) Presentations, abstracts, and manuscripts will be prepared. Table 1: Steps in Phase One and Phase Two of the Study Phase One 1) Recruit 5 experimental and 5 control subjects

2) Pre-Curricular Intervention Subject fMRi Scanning (answering multiple choice questions about laparoscopic

3) Completion of the Procedure in the Surgical Education and Activities Lab.

cholecystectomy) Phase Two 4) Curricular Intervention 5) Post Curricular Intervention

Subject fMRi Scanning (answering multiple choice questions about laparoscopic cholecystectomy)

6) Completion of the Procedure in the the Surgical Education and Activities Lab.

Background: Stress and anxiety can severely compromise the mental and physical capacities of individuals and teams, ultimately inhibiting their ability to function at the highest level during challenging clinical situations. This occurs because stress and anxiety impair central executive processes, particularly when the task being performed is complex and demands constant attention.1 Exposure to acute stress increases dopamine (DA) efflux in the prefrontal cortex (PFC) and is associated with deficits in working memory performance.2 As the ability to access working memory (i.e., the ability to recall facts) decreases, so too does the ability to simultaneously process multiple situational cues. In turn, this bottleneck impairs the functioning of procedural memory (i.e., memory that guides processes on a subconscious or automated level). Eventually, “know how” (the combination of working memory, procedural knowledge, and the ability to anticipate the consequences of the current situation) is blocked, resulting in impairment of the team’s ability to function in a coherent, collaborative manner. In addition to negatively affecting cognitive processes, there is a clear, negative impact that stress and anxiety can have on motor performance. For example, trembling hands or tense muscles greatly impair the ability to guide the use of an instrument or medical device which places the patient at risk. Additionally, as reported by the Joint Commission, anxiety induced by high-stakes, emotionally-charged situations hurts team performance and contributes to disruptive behavior.3 Furthermore, poor behavioral skills, including ineffective communication and inadequate teamwork, underlie many errors and sentinel events as reported by the Institute of Medicine.4 Most recently, in the Journal of Patient Safety, the number of premature deaths associated with preventable harm to patients was estimated at more than 400,000 per year and serious harm seems to be 10 to 20 times more common than lethal harm.5 In response to this extremely compelling need, in 2009, Drs. Ranjan Sudan and Gary Hamill began a very successful preliminary study using self-regulation and guided imagery at Duke University, Department of Surgery with eight medical students on surgery rotations. The goals were to develop the linkage of the procedural sequences, thereby accelerating their learning curve and improving their situational awareness and management of intra-operative stress. Guided imagery training modules derived from the simulation debriefings were recorded and emailed to students for them to download on their iPhone. Self-regulation and guided imagery were chosen as core components of the curriculum to improve surgical performance. While self-regulation attenuates the cognitive (worry, self-doubt, lack of concentration) and somatic (increased heart rate and respiratory rate, muscle tension) components of the anxiety response, guided imagery serves as the muscle and mental primer for optimal performance - According to recent work in neuroscience, there is a functional equivalence between action execution and the mental simulation of action, indicating that mental imagery and execution share common neural substrates.6 Guided-imagery/mental simulation training works hand-in-hand with procedural memory; in fact, memory creates the initial mental image. Once a procedure is visualized, imagery training allows one to manipulate the procedural image, i.e.,

picturing oneself performing the procedure correctly. By doing this, one is committing new information to memory and strengthening the association between the steps of the procedure. Due to the interdependence of the team members, this can translate into improved team performance and produce a shared mental model of optimal procedural performance among all members of the team. This is the process of learning, and it leads to the automation of successful behavior. Furthermore, according to the National Academy of Sciences, mental practice is one of the few performance-enhancing activities that is truly effective.7 This research was presented as a poster at the April 2011 American College of Surgeons Education Consortium. In several cases, the individual effect of the curriculum ranged from 20% to 100% improvement while completing elements of the Fundamentals of Laparoscopic Surgery (FLS) curriculum and using Laparoscopic Cholecystectomy virtual reality training. Poster data is provided below: The white video screen displays subjects’ physiologic data such as heart rate, while the image on the video screen is the subject’s view of the operative field during the procedure. Descriptors under each picture provide quantified outcomes between pre and post self-regulation / guided imagery intervention which took place one day after the baseline performance data was obtained. For the FLS pattern cutting exercise, having less than 2 cm3 of excess material when cutting out the pattern is one of the criteria for certification. This was achieved by one of the subjects. Additional specific quantitative measures included reductions in the numbers of clips used, blood loss, injury to patient, and elapsed time on completion of the procedure on the laparoscopic cholecystectomy simulator. Qualitative responses and outcomes included the following: improved procedure planning and being relaxed so subjects could think more clearly.8

More study information can be found on the Duke Surgery website at the following link: Augmenting Technical Skills Training through Application of Video, Neuro-feedback and Guided Imagery Training Additional pilot research on the psychophysiological aspects of human performance optimization were conducted in August 2013 at Stanford Neonatology’s Center for Advanced Pediatric and Perinatal Education by Drs. Halamek and Hamill.9 Two significant findings include: 1) The ability to quantify, through heart rate and heart rate variability, a psychophysiological response to cognitive load. 2) A psychophysiological zone of optimal functioning emerged during the procedure.

fMRI research will build upon these understandings and help us to develop a curriculum that will improve learning, memory, and performance under pressure. Primary Hypothesis: Intra and inter-subject spatiotemporal correlation of brain activity patterns should emerge as a result of video-based guided imagery training. Secondary Hypothesis: Subjects will improve their performance on the multiple choice procedure quiz as well as on the simulated laparoscopic cholecystectomy. Methods: Five experimental and five control physician subjects will participate in the study. They will come from surgery graduate medical education (GME) programs. Their years of training will be recorded. Phase one: All subjects will watch a brief video of waves at the beach in the MRI to establish resting brain activity during a “task free” paradigm. A surgery attending will choose a laparoscopic cholecystectomy video for all of the subjects to watch for upwards of 1 minute in the MRI. Brain activation will be recorded during this phase. After watching the video, subjects will be presented 10 multiple choice questions about the procedure. They will use a hand held button to select their response while in the MRI. Brain activation during this phase will be recorded as well as whether or not their answer was correct. Subjects will rate the difficulty of the scenario on a scale of 1-5 and their responses will be scored. After their session in the MRI is complete, all subjects will be asked to write down what they paid attention to in the video. Once the subjects complete the task in the MRI, they will go to the Duke Surgical Education and Activities Lab (SEAL) and complete a standardized, simulated laparoscopic cholecystectomy. The simulator scores their performance. Experimental subjects will be debriefed immediately following the procedure and a personalized, video-based guided imagery module will be developed for them. Control subjects will be given materials to read about performing a laparoscopic cholecystectomy. Subjects are expected to train with their respective modules at least an hour before they go back into the MRI a week later and complete phase two which follows the same protocol as phase one described above. Once the subjects complete the simulated laparoscopic cholecystectomy a second time and it is scored, their participation in the study will be complete. Limitations and Potential Solutions: Because this is a pilot study using extremely novel methodology to improve surgical performance, data is not available to support power calculations. Our goal is to demonstrate proof of concept and build upon the data collected to inform us of variability and effect size. Ultimately, this will provide us the opportunity to apply for larger grants that will support more comprehensive study.

Data Analysis Plan: We will examine the brain activation patterns between “task free” and “active” brain states, as well as study the intra and inter-subject correlation of brain activation patterns of experimental and control subjects (pre and post curricular intervention) who answer questions about the medical procedures

while in the MRI. Subject and inter-subject spatiotemporal correlation of brain activation patterns will be studied using FSL software http://fsl.fmrib.ox.ac.uk/fsl/fslwiki/. Because this study represents a very novel approach to understanding neurobehavioral responses, there is insufficient data to formally calculate sample size. However, this study will begin to inform us of the variability of neurobehavioral responses and of the effect size.

Pre and post curricular intervention multiple choice quiz and procedural outcomes (derived from the laparoscopic cholecystectomy simulator software) will also be scored. Paired sample t-tests will be used to compare the pre- and post-intervention scores on the quiz and on the procedure. The quizzes to be used in the MRI are new. As such, we do not have data to support power calculations. However, this study will begin to inform us of the variability of the quiz and of the effect size. The same is true for the simulated laparoscopic cholecystectomy procedure that will be performed by the subjects.

Budget:

IRB Approval: On 11.4.2009, Drs. Sudan and Hamill received approval from Duke IRB to conduct the following study: “Augmenting Technical Skills Training Through Applications of Video, Neuro-feedback and Guided Imagery Training” As such, the IRB is familiar with our research and we intend to build off of these accomplishments and understandings through the following study titled: “Mapping and Comparing Brain Activation in Surgeons using fMRI to Improve Surgical Performance” and are beginning the IRB application process.

Available Resources: Duke University Medical Center has state of the art MRI capabilities. The Surgical Education and Activities Lab at Duke is accredited as a Level 1 Comprehensive Education Institute by the American College of Surgeons. It has laparoscopic cholecystectomy simulators that measure procedural outcomes ranging from blood loss and hand travel through the numbers of clips used and time to completion of the procedure. In addition to Dr. Sudan’s expertise, Drs. Halamek and Hamill will also contribute to the success of this study and their letters of support are on the following pages.

Dr. Halamek Letter of Support:

Dr. Hamill Letter of Support:

NIH Biosketch:

BIOGRAPHICAL SKETCH Provide the following information for the key personnel and other significant contributors in the order

listed on Form Page 2. Follow this format for each person. DO NOT EXCEED FOUR PAGES.

NAME Ranjan Sudan

POSITION TITLE Associate Professor of Surgery

eRA COMMONS USER NAME EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, and include postdoctoral training.)

INSTITUTION AND LOCATION

DEGREE (if

applicable)

YEAR(s) FIELD OF STUDY

University of Delhi, Delhi, India 1974-1975 Pre-Medicine

Armed Forces Medical College, Pune, India M.D. 1975-1981 Medicine

Wright State University of Medicine, Dayton, OH Residency 1987-

1990 Psychiatry

College of Physicians and Surgeons of Columbia, New York City, New York

Fellowship

1991-1993

Child and Adolescent Psychiatry

Wright State University of Medicine, Dayton, OH Residency

1993-1994 1995-1999

General Surgery

Creighton University School of Medicine, Omaha, NE Residency 1994-

1995 General Surgery

A. Personal Statement

I am very enthusiastic about being a Principal Investigator for this study because it builds upon the research we accomplished in 2011 at Duke Surgery in a study called: Augmenting Technical Skills Training through Application of Video, Neuro-feedback and Guided Imagery Training. We conducted a randomized study aimed to test the hypothesis that by practicing guided imagery and self-regulation, medical students will be able to perform tasks associated with the Fundamentals of Laparoscopy Surgery (FLS) Curriculum and the laparoscopic cholecystectomy virtual reality trainer faster, with fewer errors, and with less anxiety. Our outcomes were very encouraging and were presented as a poster at the American College of Surgeons Education Consortium in April of 2011. The proposed research titled: “Mapping and Comparing Brain Activation in Surgeons using fMRI to Improve Surgical Performance” addresses an extremely important need – How surgeons cognitively organize around surgical cases. Once this is better understood, curriculum to improve learning, memory, and technical skill execution can be developed.

I am well qualified to be a Principal Investigator of the proposed study because I have a strong background in research and in surgery education and psychiatry. I trained in research in Neurophysiology with Nobel Prize nominee, Dr. Leland Clark at the Children’s Hospital in Cincinnati and was a co-investigator on several NIH grants. After completing my fellowship in neurophysiology, I completed a residency in Psychiatry from Wright State University and a fellowship in Child Psychiatry from Columbia University. I then went on to complete a residency in Surgery from Wright State University. I am actively involved in surgery education as Vice Chair of Education in Surgery at Duke University Medical Center. I was previously residency program director and Associate Chair for Education at Creighton University. In all of these roles I have mentored several residents and fellows and realize the time and effort in doing so. I have been an active member of in the Association for Surgical Education, serving as the Chair of the Committee on Curriculum and have actively participated as presenter and moderator of education sessions at the Academic Surgical Congress. Given my experience in psychiatry and surgery, I bring a very strong understanding of the psychophysiological underpinnings of human performance to this study, as well as being able to translate it to effective methods for improving learning and performance under pressure. B. Positions and Honors. Employment March 1981 to Dec 1983 Medical Officer, Lagos State Health Management Board, Lagos, Nigeria Jan 1991 to June 1991 Assistant Professor, Associate Director of Residency Training, Clerkship

Director, Department of Psychiatry, Wright State University School of Medicine, Dayton, OH

June 1999 to July 2002 Assistant Professor of Surgery, Director of Bariatric Surgery, University of Nebraska Medical Center, College of Medicine, Department of Surgery, Omaha, NE

August 2002 to Sept 2008 Associate Professor of Surgery and Psychiatry, Director of Bariatric and Robotic Surgery, Creighton University Medical Center, Omaha, NE

April 2004 to Sept 2008 Director, Residency Program, Creighton University Medical Center, Omaha, NE

Jan 2005 to Sept 2008 Associate Chair of Medical Education, Creighton University Medical Center, Omaha, NE

Oct 2008 to present Vice Chair of Education, Director of Bariatric Surgery Duke University Medical Center, Durham, NC

Dec 2009 to present Associate Professor of Surgery Associate Professor of Psychiatry Duke University Medical Center, Durham, NC Honors 1992-1993 Elected Chief Fellow in Child Psychiatry at Columbia University

Pilot funds, $5000, to start studies involving Sleep EEG and Growth Hormone in response to clonidine challenge at Columbia University.

1993 Edward Sacher Award for Clinical Excellence In Child Psychiatry, Columbia University.

1996 Chairman’s award for highest score on the ABSITE examination, Wright State University.

1997 Young Investigator Award of the American Society of Transplant Physicians 1999 Resident Research Paper Award for "Long Term Outcomes of Simultaneous

Kidney Pancreas Transplantation," Wright State University. 2001 Nebraska Health System Extraordinary Care Award for participation Physician

Practice Digest Program for the "Surgeons Perform First Robotic Surgery at NHS."

2003 Creighton University Medical Center Target 100 Customer Service Award 2004 Creighton University Medical Center Target 100 Customer Service Award 2005 Creighton University Medical Center Target 100 All Star 2006 Creighton University Medical Center Doctor’s Day Medal for excellence in Patient Care. 2011 Nominee, 2011 Leonard Palumbo, Jr. MD Faculty Achievement Award, Duke

University School of Medicine. National Committees: 2004 – present Research Committee, American Society for Metabolic and Bariatric Surgery 2005 – present Curriculum Committee, Association of Surgical Education 2008-2010 Co-Chair, Research Committee, American Society for Metabolic and Bariatric

Surgery 2009 – 2011 Vice Chair, Curriculum Committee, Association of Surgical Education 2010 – 2011 Patient Care Committee, The Society for Surgery of the Alimentary Tract 2010 – present Chair, Research Committee, American Society for Metabolic and Bariatric

Surgery 2010 - 2011 Chair, Research Advisory Committee, Surgical Review Corporation. 2011 – present Chair, Curriculum Committee, Association of Surgical Education 2011 – present Association for Surgical Education, Program Committee 2011-Present Board of Directors Association for Surgical Education Board Member 2011-Present American College of Surgeons, Task Force for Resident OSCE 2011-Present American Society for Metabolic & Bariatric Surgery, Member Quality and

Standards Committee 2011-Present Chair, The Society for Surgery of the Alimentary Tract, Continuing Education

Committee 2011-Present American College of Surgeons, Expert Panel on Dealing with a Problem Resident 2012-Present Co-Chair, American College of Surgeons and Association for Surgical Education,

Joint Task Force for National Surgery Core Curriculum 2012–2013 Co-Chair, Association for Surgical Education, Program Committee 2012-2014 American Society for Metabolic & Bariatric Surgery, Member Program

Committee. 2012–Present American College of Surgeons, Task Force for ASPIRES program 2012–Present Clinical Robotic Surgery Association, Founding Member 2013–Present Society of University Surgeons, Member Education Society C. Selected Relevant Peer-Reviewed Publications 1. Clark, Jr., L.C., Spokane, R.B., Hoffmann, R.E. , Sudan, R., Homan, M.M., Maloney, A.C., Stroup,

T.L., & Winston, P.E. Polarographic cerebral oxygen availability, fluorocarbon blood levels and efficacy of oxygen transport emulsions. Biomatr Artif Cells Artif Organs 1987; 16:409.

2. Clark, Jr., L.C., Noyes, L.K., Spokane, R.B., Sudan, R., & Miller, M. Design and long term performance of surgically implanted electroenzymatic glucose sensors. Annals of NY Academy of Science 1987 Jun; 501:534-37.

3. Clark, Jr., L.C., Spokane, R.B., Homan, M.M., Sudan, R. & Miller, M Long term stability of electroenzymatic glucose sensors implanted in mice, an update. Trans Am Soc Artif Intern Organs, transactions 1988 Jul-Sep; 34:259-265.

4. Clark, Jr., L.C., Noyes, L.K., Spokane, R.B., Sudan, R., & Miller, M.L. Long-term implantation of voltammetric oxidase/peroxide glucose sensor in the rat peritoneum. Methods in Enzymology 1988; 137:68-69.

5. Clark, Jr., L.C., Spokane, R.B., Homan, M.M., Sudan, R. The nature of fluorocarbon enhanced cerebral oxygen transport. Adv Exp Med Biol 1989; 248:341-55.

6. Sudan R., Setterberg S., Whitaker A., Kestenbaum C. An Emerging Schizophrenic Syndrome. Journal Of the American Academy of Child and Adolescent Psychiatry 1993 Nov; 32(6): 1295-301

7. Sudan, D., Sudan, R., Schafer, D., Langnas, A. Without victory there is no survival: Transarterial lipiodol chemoembolization and hepatocellular carcinoma. Hepatology 1998 Jul; 28(1): 270-271.

8. Sudan, D., Sudan, R., Stratta, R. Long-Term Outcome of Simultaneous Kidney-Pancreas Transplantation: Analysis of 61 Patients with More than 5 Years Follow-up. Transplantation 2000 Feb; 69(4):550-555.

9. Yohannes, P., Puri, V., Yi, B., Khan, A.K., Sudan, R. Laparoscopy-Assisted Robotic Radical Cystroprostatectomy with Ileal Conduit Urinary Diversion for Muscle-Invasive Bladder Cancer: Initial Two Cases. J of Endourology 2003 Nov; 9(17):729-732.

10. Yohannes, P., Rao, M., Burjonrappa, S., Sudan, R. Laparoscopic Nephron-Sparing Surgery in a Jehovah’s Witness patient. J Endourol 2004 Feb; 18(1):59-62.

11. Yohannes, P., Khan, A., Francis, K., Sudan, R. Robot-Assisted Bricker Ileoureteral Anastomosis During Intracorporeal Laparoscopic Ileal Conduit Urinary Diversion For Prostatocutaneous Fistula: case report. J Endourol 2004 Apr; 18(3):269-272.

12. Richardson, B.E., Vander Woude, E.A., Sudan, R., Thompson, J.S., Leopold, D.A. Altered Olfactory Acuity in the Morbidly Obese. Obes Surg 2004 Aug; 14(7):967-969.

13. Sudan, R., Puri, V., Sudan, D. Robotically assisted biliary pancreatic diversion with a duodenal switch: a new technique. Surgl Endosc 2007 May; 21(5):729-33. (Epub 2007 Feb 17)

14. Puri, V., Ramachandran, J., Sudan, R. Experience with Duodenal Switch operation in the presence of malrotation. Obes Surg 2008 May; 18(5):615-7.

15. Upadhyaya, P.K., Chava, S., Bin Sangheer, S., Sudan, R., Mittal, S.K., Cemaj, S. Delayed Rupture of a spleenic artery peudoaneurysm after Biliopancreatic diversion. Obes Surg 2008 July; 18(7): 890-2. (Epub 2008, May 17).

16. Kasotakis, G., Sudan, R. Retrograde intussusception after Roux-en-Y gastric bypass for morbid obesity. Obes Surg 2009 Mar; 19(3):381-4.

17. Sudan, R., Kasotakis, G., Betoff, A., Wright, A. Sleeve Gastrectomy Strictures: Technique for Robotic-Assisted Strictureplasty. Surgery for Obesity and Related Disease 2010 Jul-Aug; 6(4):434-6.

18. Kasotakis, G., Mittal, S.K, Sudan, R. Combined treatment of symptomatic massive paraesophageal hernia in the morbidly obese. Journal of the Society of Laparoendoscopic Surgeons 2011 Apr-Jun; 15(2):188-92.

19. Sudan, R., Desai, S. Emergent and Weekend Robotic Surgery is Feasible. Journal of Robotic Surgery 2011 Jun;. DOI 10.1007/s11701-011-0289-0.

D. Research Support Ongoing Research Support: Guided Imagery Sudan, Ranjan (PI) Funded 2009 $50,000

BIOGRAPHICAL SKETCH NAME Louis P. Halamek

POSITION TITLE Professor of Pediatrics, Division of Neonatal and Developmental Medicine, Department of Pediatrics, Stanford University, Stanford, CA

eRA Commons ID halamek EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, and include postdoctoral training.)

INSTITUTION AND LOCATION DEGREE (if applicable) YEAR(s) FIELD OF STUDY

Creighton University, Omaha, NE BS 1977-81 Chemistry Creighton University, Omaha, NE 1981-82 Chemistry Creighton University School of Med, Omaha, NE MD 1982-86 Medicine

U of Nebraska Medical Center, Omaha, NE Resident 1986-89 Pediatrics

U of Nebraska Medical Center, Omaha, NE Chief Resident 1989-90 Pediatrics

Stanford University School of Med, Stanford, CA Fellow 1990-93 Neonatal-Perinatal

Med A. Personal Statement The goal of the proposed research is to better understand how surgeons cognitively organize while performing procedures. The ability to perform under life or death circumstances has many parallels with neonatology such as leading the resuscitation of a newborn and other neonatal emergency procedures. As such, I believe both disciplines can inform one another very well regarding the ability to perform under extreme pressure situations. My background as described below (in clinical neonatology, healthcare simulation, human performance, patient safety and program implementation on a national level) provides me with extensive practical experience that will help me support this work to a successful conclusion. I am a Professor in the Medical Center Professoriate in the Division of Neonatal and Developmental Medicine, Department of Pediatrics, and the Division of Maternal-Fetal Medicine, Department of Gynecology and Obstetrics (by courtesy) at Stanford University. I am also a Senior Fellow in the Center for Aviation Safety Research and Adjunct Faculty in the Department of Aviation in the Parks College of Engineering, Aviation and Technology at St. Louis University. I am certified by the American Board of Pediatrics in both Pediatric Medicine and Neonatal-Perinatal Medicine and am a Fellow in the American Academy of Pediatrics. I have a clinical appointment at Lucile Packard Children’s Hospital at Stanford where I work in the level IV neonatal intensive care unit. Through my activities with the annual Safety Across High Consequences Industries Conference sponsored by St. Louis University and ongoing collaboration with colleagues at NASA's Johnson Space Center in Houston, Texas, I have learned the benefits of a cross-industries approach to risk assessment, safety and effectiveness. My current work centers on the optimization of human performance, analysis of human and system error, and the use of research and training methodologies such as simulation.

In 2002 I founded the Center for Advanced Pediatric and Perinatal Education (CAPE, http://www.cape.lpch.org), the world's first such center dedicated to fetal, neonatal, pediatric and obstetric simulation, located at the Lucile Packard Children's Hospital on the campus of Stanford University. Since its founding CAPE has become internationally recognized for its role in the use of simulation as a learning and research methodology. CAPE’s Simulation Instructor Training Program has been attended by trainees from throughout the U.S. and around the world and a series of visiting scholars have come to CAPE to gain knowledge and experience. I and my team at CAPE have established a track record of using simulation as a research strategy to answer clinically relevant questions that are difficult to study in the real clinical environment. I have served as Co-chair of the Steering Committee of the Neonatal Resuscitation Program (NRP) of the American Academy of Pediatrics (AAP); the NRP has over 27,000 instructors distributed throughout the U.S. and has been delivered to more than 3 million trainees during its 20+ year history. In my role as Steering Committee Co-chair I facilitated the transition of the NRP from a textbook and skills station-based training program into a simulation-based immersive learning experience. I am currently a Special Consultant in Simulation- and Virtual Reality-based Learning to the NRP. In addition I am a member of the Neonatal Delegation of the International Liaison Committee on Resuscitation (ILCOR). Together NRP and ILCOR set the national and international standards for resuscitation of the newborn. By working through these large organizations the work conducted at CAPE by my team is playing a role in the care of patients around the U.S. and the world. B. Positions and Honors Positions and Employment 1992-1994 Staff Physician, Division of Neonatal and Developmental Medicine, Department of

Pediatrics, Stanford University, School of Medicine, Stanford, CA 1994-1995 Acting Assistant Professor, Stanford University, School of Medicine, Stanford, CA 1995-2001 Assistant Professor, Stanford University, School of Medicine, Stanford, CA 2001-2011 Associate Professor, Stanford University, School of Medicine, Stanford, CA 2011- Professor, Stanford University, School of Medicine, Stanford, CA Other Experience and Professional Memberships 1986-1993 American Academy of Pediatrics, Resident Candidate 1993- American Academy of Pediatrics, Fellow 1994- American Academy of Pediatrics, Section on Perinatal Pediatrics 1994- American Academy of Pediatrics, District IX, Section on Perinatal

Pediatrics 1994- California Association of Neonatologists 1997- Western Society for Pediatric Research 2001- Society for Pediatric Research 2001- American Association for the Advancement of Science 2004 - Society for Simulation in Healthcare 2012- International Pediatric Simulation Society C. Selected peer-reviewed publications (of 78) 1) Geurtzen R, Hogeveen M, Rajani AK, Chitkara R, Antonius T, van Heijst A, Draaisma J, Halamek

LP. Using simulation to study difficult clinical issues: Prenatal counseling at the threshold of viability across American and Dutch cultures. Accepted, J Simul Healthc 2013.

2) Butler TJ, Lavin JP, Suresh GK, Oehlert JW, Schriefer JA, Halamek LP. Development of a multi-center multidisciplinary simulation-based perinatal team training program: The Vermont Oxford Network experience. Accepted, Asian J Clin Pediatr Neonatol 2013.

3) Halamek LP. Simulation as a methodology for assessing the performance of healthcare professionals working in the delivery room. Accepted, Sem Perinatol 2013.

4) Halamek LP. The rationale and strategy for rigorous human performance assessment in neonatal-perinatal medicine. Accepted, NeoReviews 2013.

5) Halamek LP. Bringing latent safety threats out into the open. Jt Comm J Qual Patient Saf 2013;39(6):267. PMID: 23789164

6) Amin HJ, Aziz K, Halamek LP, Beran TN. Simulation-based learning combined with debriefing: Trainers satisfaction with a new approach to training the trainers to teach neonatal resuscitation. BMC Res Notes 2013;6(1): 251-255. PMID: 23827017

7) Chitkara R, Rajani AK, Lee HC, Snyder SF, Halamek LP. Comparing the utility of an ergonomic neonatal resuscitation cart with a generic code cart: A randomized, controlled, crossover trial. BMJ Qual Saf 2013;22(2):124-129. PMID: 23112286

8) Chitkara R, Rajani AK, Oehlert JW, Halamek LP. Accuracy of human senses in the detection of neonatal heart rate during standardized simulated resuscitation: Implications for delivery of care, training and technology design. Resuscitation 2013;84(3):369-372. PMID: 22925993

9) Finer NN, Rich W, Halamek LP, Leone TA. The delivery room of the future: The fetal/neonatal resuscitation and transition suite. Clin Perinatol 2012;39(4);931-939. PMID: 23164188

10) Rajani AK, Chitkara R, Oehlert J, Halamek LP. Comparison of umbilical venous and intraosseous access during simulated neonatal resuscitation. Pediatrics 2011;128(4):e954-958. PMID: 21930542

11) Lipman SS, Daniels KI, Arafeh J, Halamek LP. The case for OBLS: A simulation-based obstetric resuscitation curriculum. Sem Perinatol 2011;35:74-79. PMID: 21440814

12) Halamek LP. Lost moon, saved lives: Using the movie Apollo 13 as a video primer in behavioral skills for simulation trainees and instructors. J Simul Healthc 2010;5(5):303-310. PMID: 21330813

13) Halamek LP. Simulation: The new “triple threat”. Pediatr Res 2010;67(2):130-1. PMID: 20081486

14) Kattwinkel J, Perlman JM, Aziz K, Colby C, Fairchild K, Gallagher J, Hazinski MF, Halamek LP, Kumar P, Little G, McGowan JE, Nightengale B, Ramirez MM, Ringer S, Simon WM, Weiner GM, Wyckoff M, Zaichkin J. Neonatal resuscitation: 2010 American Heart Association guidelines for cardiopulmonary resuscitation and emergency cardiovascular care. Pediatrics 2010;126(5):e1400-e1413. PMID: 20956432

15) Kattwinkel J, Perlman JM, Aziz K, Colby C, Fairchild K, Gallagher J, Hazinski MF, Halamek LP, Kumar P, Little G, McGowan JE, Nightengale B, Ramirez MM, Ringer S, Simon WM, Weiner GM, Wyckoff M, Zaichkin J. Part 15: Neonatal resuscitation: 2010 American Heart Association guidelines for cardiopulmonary resuscitation and emergency cardiovascular care. Circulation 2010;122:S909-S919. PMID: 20956231

16) Halamek LP. Simulation: The new “triple threat”. Pediatr Res 2010;67(2):130-1. PMID: 20081486

17) Lee HC, Chitkara R, Halamek LP, Hintz SR. A national survey of pediatric residents and delivery room training experience. Pediatrics 2010;157(1):158-161. PMID: 20304418

18) Rajani AK, Chitkara R, Halamek LP. Delivery room management of the newborn. Pediatr Clin North Am. 2009;56:515-535. PMID: 19501690

19) Halamek LP. The simulated delivery room environment as the future modality for acquiring and maintaining skills in fetal and neonatal resuscitation. Semin Fetal Neonatal Med. 2008;13:448-453. PMID: 18524705

20) Weinstock P, Halamek LP. Teamwork during resuscitation. Pediatr Clin North Am. 2008;55:1011-24. PMID: 18675031

21) Halamek LP. The simulated delivery room environment as the future modality for acquiring and maintaining skills in fetal and neonatal resuscitation. Semin Fetal Neonatal Med. 2008;13:448-453. PMID: 18524705

22) Halamek LP. Teaching versus learning and the role of simulation-based training in pediatrics. J Pediatr 2007;151(4):329-330. PMID: 17889060

23) Wayman K, Yaeger KA, Sharek PJ, Trotter S, Wise L, Flora JA, Halamek L. Simulation-based medical error disclosure training for pediatric healthcare professionals. J Healthc Qual 2007;29(4):12-19. PMID: 17849675

24) Halamek LP, Morley C. Continuous positive airway pressure. Clin Perinatol, 2006;33(1):83-98. PMID: 16533635

25) Zabari M, Suresh G, Tomlinson M, Lavin J, Larison K, Halamek LP, Schriefer J. Implementation and case study results of potentially better practices for collaboration between obstetrics and neonatology to achieve improved perinatal outcomes. Pediatrics 2006;118Suppl2:S153-S158. PMID: 17079618

26) Ohlinger J, Kantak, A, Lavin J, Fofah O, Hagen E, Suresh G, Halamek L, Schriefer J. Evaluation and development of potentially better practices for perinatal and neonatal communication and collaboration. Pediatrics 2006;118Suppl2:S147-S152. PMID: 17079617

27) Anderson JM, Murphy AA, Boyle BB, Yaeger KA, Halamek L. Simulating extracorporeal membrane oxygenation (ECMO) emergencies, Part II: Qualitative and quantitative assessment and validation. Simulation in Healthcare, 2006;1:228-232. PMID: 19088594

28) Anderson JM, Murphy AA, Boyle BB, Yaeger KA, Halamek L. Simulating extracorporeal membrane oxygenation (ECMO) emergencies to improve human performance, Part I: Methodologic and technologic innovations. Simulation in Healthcare 2006;1:220-227. PMID: 19088593

29) Agarwal S, Swanson S, Yaeger KA, Murphy AA, Halamek LP. Utilizing simulation to compare the standard pediatric code cart with a pediatric code cart based on the Broselow tape. Pediatrics 2005;116(3):e326-e333. PMID: 15609254

30) Halamek LP, Kaegi DM, Gaba DM, Sowb YA, Smith BC, Smith BE, Howard SK. Time for a new paradigm in pediatric medical education: Teaching neonatal resuscitation in a simulated delivery room environment. Pediatrics 2000;106(4):e45-e50. PMID: 11015540 URL: http://www.pediatrics.org/cgi/content/full/106/4/e45

D. Research Support (Current) 1. T32 HD007249-26,  Developmental and Neonatal Biology Training Program  

Role: Associate Director,  05/01/09-04/30/14  This training grant supports a broad program involving undergraduate, graduate and post-residency trainees in developmental biology.

2. Endowment for the Center for Advanced Pediatric and Perinatal Education Role: Director, 11/01/02-present This endowment supports 20% of Dr. Halamek’s effort.

BIOGRAPHICAL SKETCH

NAME Gary Hamill, Ed.D.

POSITION TITLE Senior Research Scholar, Stanford University Medical School, Department of Pediatrics, Division of Neonatal Medicine

eRA COMMONS USER NAME (credential, e.g., agency login) ghamill ghamill EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable.)

INSTITUTION AND LOCATION DEGREE

(if applicable)

MM/YY FIELD OF STUDY

Saint Anselm College, Manchester, NH B.A. 05/1987 History

Seton Hall University, South Orange, NJ M.A. 09/1991 Counseling Psychology

Fordham University, Bronx, NY P.D. 1/1994 Counseling Psychology

Boston University, Boston, MA Ed.D. 05/1996

Developmental Studies-Human Performance Optimization

NOTE: The Biographical Sketch may not exceed four pages. Follow the formats and instructions below.

A. Personal Statement With a doctorate specializing in human performance optimization and graduate education training in counseling psychology, I have helped professional, collegiate, and amateur athletes perform at their highest levels during very competitive, stressful situations for over a decade by incorporating psychophysiological training into their regimens. During this timeframe, I was also a Division 1 Strength and Conditioning coach and worked with these athletes on integrating mental and physical aspects of peak performance training. Furthermore, I consulted with Team USA Volleyball (Olympics) for 4 years as a member of the Psychosocial Research Advisory Team. I have over 50 commercial publications and presentations on peak performance and have interviewed some of the top athletes in the world including Steve Young, 1994 NFL Superbowl MVP, Tyrrell Davis, 1997 NFL Superbowl MVP, Karl Malone, NBA 50 greatest players, as well as Eddie George, 1996 NFL Rookie of the Year. For the past 5 years, I translated this expertise in peak performance training to developing curriculum and helping healthcare professionals and teams at Duke University Medical School and most recently at Stanford University Medical School to perform under pressure by increasing their psychomotor capacity through psychoneuromuscular training - incorporating guided imagery (visualization) and biofeedback assisted self-regulation. Early success of this research at Duke resulted in a poster

presentation for the 2011 American College of Surgeons Educational Consortium. Its title was “Augmenting Technical Skills Training Through Applications of Video, Neuro-feedback and Guided Imagery Training” More detail is available under the research section of this biosketch and in the application attachments section.

In 2011, I accepted a position as an Assistant Dean of Educational Informatics at Albert Einstein College of Medicine. During that time, I was appointed Co-Chair of the Simulation Subcommittee for the Association of American Medical Colleges based on my expertise in Human Performance Optimization and accomplishments in simulation research and instructional technology.

I am able to translate the expertise from these positions into new pedagogical approaches for medical education and given my educational informatics expertise, am able to create electronic curriculum for dissemination. In turn, given my current position at Stanford University as Senior Research Scholar in the Division of Neonatology, one area of research focus includes team adaptation and synchronization - We are investigating shared mental models, automated procedural behavior, situational awareness, stress management, and medical decision-making. The study title for this pilot research is “Using Psychophysiological Strategies to Manage Psychomotor Load and Improve Team Performance”. Aspects of this research was recently presented to the Association of American Medical Colleges. More detail is available under the research section of this biosketch.

Given the depth and breadth of my expertise in Human Performance Optimization and very successful applications to healthcare professionals to improve performance in high stakes, high emotion situations, I am very well qualified to be a Co-Investigator in this study that will help advance our understanding of how surgeons learn, remember, and perform under pressure as well as develop curriculum that supports these outcomes.

B. Positions and Honors Positions and Employment 1990 – 1991 Strength and Conditioning Coach, Seton Hall University 1992 – 1993 Strength and Conditioning Coach, Fordham University 1994 – 2000 Consultant, The Performance Enhancement Center 2000 – 2001 Senior Healthcare Analyst, Santa Clara Valley Medical Center 2001 – 2002 Corporate Compliance Coordinator, California Pacific Medical Center 2002 – 2007 Residency Faculty / Operations Manager, Tufts University Family Medicine Residency 2007 – 2008 Business Manager, Duke University Department of OBGYN 2008 – 2011 Program Administrator, Duke University Graduate Medical Education, Departments of

Medicine and Psychiatry 2011 – 2012 Assistant Dean, Educational Informatics, Albert Einstein College of Medicine 2008 – Peak Performance Consulting Associate, Duke University Medical School, Department

of Surgery 2013 – Senior Research Scholar, Human Performance Optimization, Stanford University,

Department of Pediatrics, Division of Neonatology

Other Experience and Professional Memberships 2001 - 2007 Association of Family Medicine Administration

2002 - 2012 Editorial Board, Aspen Publishing. Hospital Legal Forms, Checklists, and Guidelines 2002 - 2007 Medical Group Management Association 2006 - 2007 Treasurer / Fundraising Chair, Association of Family Medicine Administration 2009 - 2011 American Association of Directors of Psychiatric Residency Training 2011 - 2012 Education Innovations Subcommittee, Association of Medical Schools of New York 2011 - Society for Simulation in Healthcare 2011 - Education Informatics Committee, Association of American Medical Colleges 2012 - Co-chair on Simulation Subcommittee, Association of American Medical Colleges I have made many presentations regarding the psychophysiology of optimal performance to organizations such as Association of American Medical Colleges, the Stanford Department of Pediatrics, the American College of Surgeons (ACS), the National Hockey League (NHL) and to the United States Tennis Association (USTA) held in conjunction with the U.S. Open. Additionally, I have over 40 commercial publications in peak performance. Select publishers include CBS Sports, Fox Sports, College and Pro Football Newsweekly, the National Collegiate Athletic Association, and Conditioning Press. Select interviews include Steve Young, 1994 NFL Superbowl MVP, Tyrrell Davis, 1997 Superbowl MVP and Karl Malone, NBA 50 Greatest Players, as well as Eddie George, 1996 NFL Rookie of the Year.

C. Selected Peer-reviewed Publications None  at  this  time.    Please  refer  to  above  paragraph  for  reference  to  over  40  commercial  publications.  

D. Research Support Ongoing Research Support: Stanford Dean of Research The Stanford Center for Cognitive and Neurobiological Imaging Stanford University “Mapping and Comparing Brain Activation in Physicians: Role of Experience” 10/13 –present Goals: The goal of this pilot research is to correlate intra and inter subject spatiotemporal brain activation patterns while solving medical scenarios with varying degrees of difficulty. Responsibilities: At Stanford, as Co-Investigator, I am facilitating the protocols and will be conducting the data analysis using FSL software. Center for Advanced Pediatric and Perinatal Education (CAPE), Division of Neonatology, Department of Pediatrics, Stanford University Medical School 7/13-present “Using Psychophysiological Strategies to Manage Psychomotor Load and Improve Team Performance” Goals: The goal of this pilot research is to improve team synchronization by developing strategies and curriculum that:

• Improve team-based situational awareness, procedure sequencing, cognitive organization, and self-regulation.

• Develop patient care teams that are more relaxed and focused.

• Increase team psychomotor capacity so they can quickly adapt to emergency situations and

make better decisions under high pressure to improve patient care. Responsibilities: At Stanford, as Co-Investigator, I am leading the protocols in the Center for Advanced Pediatric and Perinatal Education (CAPE) which includes use of psychometric instruments, physiological status monitoring, facilitating video-based team debriefings, and creating team-based guided imagery modules that can be played on subjects’ iphones. Am also responsible for data analysis. Pilot findings were presented to the Association of American Medical Colleges in October 2013. For more background on this research, please see the video at the following link: http://youtu.be/VZSZNU_xSGo Completed Research Support Graduate Medical Education, Duke University Medical School 1/09 – 4/11 “Augmenting Technical Skills Training Through Applications of Video, Neuro-feedback and Guided Imagery Training”

Goals:

• Develop the execution of the procedural sequences for the laparoscopic cholecystectomy and the Fundamentals of Laparoscopic Surgery program for medical students on surgical rotations.

• Improve student situational awareness and management of intra-operative stress.

• Accelerate student learning curves.

Responsibilities: At Duke Surgery, as Co-Investigator, I led the protocols in the surgery lab and used video-based debriefing with the students. The debriefings created the content for electronic, procedural specific, guided imagery modules which I developed and emailed to students to play on their iphones, etc.

For more background, please see attached link on the Department of Surgery Simulation Lab Research page for additional description of the grant called Augmenting Surgical Technical Skills Through Applications of Video, Neuro-feedback, and Guided Imagery Training. Study findings were presented in a poster session at the Educational Consortium for the American College of Surgeons in April 2011 and the Association of American Medical Colleges in October 2013.

Participation in SAGES: Dr. Sudan has been a member of SAGES for the last 14 years and has provided many abstracts, papers, and presentations on robotic / bariatric surgery. References: 1. Derakshan N, Eysenck M. Anxiety, Processing Efficiency, and Cognitive Performance. New

Developments from Attentional Control Theory. European Psychologist 2009;14(2):168-176. 2. Buttsa KA, Weinbergb J, Younga AH, Phillipsa AG, Glucocorticoid receptors in the prefrontal

cortex regulate stress-evoked dopamine efflux and aspects of executive function. Proceedings of the National Academy of Sciences of the United States of America. September

27, 2011. http://www.pnas.org/content/108/45/18459 Accessed October 20, 2013. 3. The Joint Commission. Behaviors that Undermine a Culture of Safety. Sentinel Event Alert.

2008(40): 1-3. http://www.jointcommission.org/assets/1/18/SEA_40.PDF Accessed August 10, 2013.

4. Kohn LT, Corrigan JM, Donaldson MS. eds. To Err Is Human: Building a Safer Health System. Washington, DC: National Academy Press; 2000.

5. James JT. A New, Evidence-based Estimate of Patient Harms Associated with Hospital Care. Journal of Patient Safety. 2013; 9(3): 122-128.

6. Beilock S, Lyons I. Expertise and the Mental Simulation of Action. In: Markman K, Klein W, Suhr J. eds. Handbook of Imagination and Mental Simulation. London, UK: Psychology Press; 2008. 21-34.

7. Kosslyn S, Moulton S. Mental Imagery and Implicit Memory In: Markman K, Klein W, Suhr J. eds. Handbook of Imagination and Mental Simulation. London, UK: Psychology Press; 2008. 35-51.

8. Sudan R, Hamill, G. (2011, April) Augmenting Technical Skills Training through Application of Video, Neuro-feedback and Guided Imagery Training. Poster Presentation at the meeting of the Education Consortium for the American College of Surgeons, Chicago, IL.

9. Halamek L, Hamill, G. (2013, August) Using Psychophysiological Strategies to Manage Psychomotor Load and Improve Team Performance. Unpublished research. The Center for Advanced Pediatric and Perinatal Education. Stanford University Medical School, Department of Pediatrics, Division of Neonatology. Palo Alto, CA.