15TH SLS ANNUAL MEETING AND ENDO EXPO 2006 GENERAL SESSIONS
BEST OF LAPAROSCOPY UPDATES
7:30am Thursday, September 7, 2006
UPDATE ABDOMINAL AND PELVIC PAIN
Please Check My Bladder Before You Remove My Female Organs! It Is Not Just Endomeriosis: the New Insight of Treating Low Abdominal and Pelvic Pain in Women
Maurice Chung, RPh, MD
Chronic pelvic pain (CPP) is estimated to affect more than 9 million women in the United States. Up to 40% of laparoscopies and 10% to 12% of all hysterectomies are performed for CPP. In addition to lost productivity and decreased quality of life, the diagnosis and treatment of CPP consumes nearly $3 billion of health care expenditures annually.
The management of CPP is challenging due to the numerous possible differential diagnoses and contributing factors associated with this condition. Possible differential diagnoses include endometriosis, endosalpingiosis, pelvic adhesions, ovarian remnant syndrome, interstitial cystitis (IC), adenomyosis, and uterine leiomyomatas. These conditions may present with similar symptoms, and one or more may exist concomitantly in a given patient. Endometriosis is one of the more prevalent gynecologic diagnoses among women with CPP, affecting more than half of those patients who receive a diagnosis for their CPP. The symptoms of endometriosis include dyspareunia, cyclic perimenstrual low abdominal pelvic pain, symptom flares after sexual intimacy, and irritative voiding in the case of urinary tract involvement. A definitive diagnosis of endometriosis requires visual confirmation of the lesion during laparoscopy, and histologic confirmation of the presence of both ectopic endometrial glands and stroma. Interstitial cystitis, or pelvic pain of bladder origin, is a disorder that may be associated with CPP. The etiology of IC is unclear, but it is thought to be multifactorial and progressive, involving bladder epithelial dysfunction, mast cell activation, and bladder sensory nerve upregulation. The prevalence of IC in the United States range from 10 to 510/100,000 cases. Recent evidence suggests that this condition may, in fact, be much more prevalent than current estimates.
The symptoms of IC include urinary urgency/frequency and/or pelvic pain in the absence of urinary tract infection. Patients may also report dyspareunia and/or cyclic pain in association with the menses. Some patients may present with only urologic symptoms; conversely, 15% of patients present with chronic pain and no urologic symptoms. Patients with early IC may have only 1 or 2 symptoms, whereas at later stages, the full spectrum of symptoms may emerge and bladder capacity may be reduced. Recent data suggest that outcomes may be improved when IC is detected and treated at earlier stages. Therefore, it is important that health providers need to think of treating and evaluation chronic pelvic pain as a disease of multi-organ systems in women.
We will discuss some of the new findings in evaluation of chronic pelvic pain in women.
UPDATE BARIATRIC SURGERY
Alex Gandsas, MD
During the 2004 annual meeting, the Bariatric Surgery update was focused on surgical outcomes as well as emergent technologies for bariatric surgery.
This year we are planning to look at the growth of obesity and the increase in the amount spent in treating all major weight related co-morbidities. Interestingly, recent studies have shown that the cost of health care in morbidly obese patient has increased 5 times over the last 18 years.
We will bring an updated report from the Surgical Review Corporation regarding Centers of Excellence and review all necessary steps that are required to obtain such endorsement. We will also look at how the new CPT codes impact the current reimbursement game, including the new Medicare policy to cover weight loss surgery.
Finally, we will discuss the rise of the number of patients requesting revisional surgery, although, not many centers are offering such alternative as well as Centers offering bariatric surgery in the ambulatory setting.
Role of Deep Intramural Fibroids
on In Vitro Fertilization Outcome
Charles H. Koh, MD
The role of deep intramural fibroids that do not distort the uterine cavity in reproduction has not been well categorized in the past. Recently, much literature has emerged comparing IVF outcomes in the presence of such lesions but the conclusions remain controversial. This presentation will review the evidence and present techniques for removing deep intramural fibroids without causing harm to the existing pelvic infrastructure.
UPDATE ROBOTIC SURGERY
Computer Enhanced “Robotic” Surgery
William E. Kelley, Jr., MD
On July 12, 2000, the first computer-enhanced surgical system became FDA approved for abdominal and pelvic laparoscopic surgery in the United States. FDA approval followed in 2003 and 2004 for cardiac surgery, specifically for robot-assisted mitral valve replacement and robot-assisted CABG respectively.
Computer-enhanced surgery provides improved precision through motion scaling technology and electronic filtering. Wrists at the end of the laparoscopic instruments provide 360-degree rotation and flexion within 2 cm of the instrument tips. These mechanical advantages offer the surgeon a precision of movement that cannot be duplicated with traditional laparoscopic or open instruments. In addition, a true 3-dimensional visual system gives the surgeon much more precision with the instrumentation. These mechanical and visual advantages allow most surgeons to be ambidextrous with dissecting and suturing techniques.
At the current stage of development, the computer-enhanced technology has been most useful for complex dissecting and suturing techniques, especially in small, poorly accessible locations. The flexibility of the instrumentation has greatly facilitated dissection and suturing for radical prostatectomy. The majority of centers that currently have robotic systems, many of which had had no previous experience with laparoscopic radical prostatectomy, are utilizing the robot for this technique. Gynecologic applications have thus far been limited to infertility surgery for tuboplasty and tubal reanastomosis.
For general surgery, the instrumentation has shown substantial advantage for laparoscopic Heller myotomy, with a significant reduction in the incidence of mucosal perforation. Other procedures that have been enhanced by this technology include laparoscopic esophagectomy, pancreatectomy, laparoscopic pyloroplasty when performed at the time of anti-reflux surgery, and suturing the posterior suture lines of Toupet fundoplication.
For vascular surgery, experience is now growing with robot-assisted laparoscopic aortofemoral bypass and laparoscopic aortic aneurysmectomy. In our center, we have experienced hospital stays of 2.5 days following aortofemoral bypass, with the patient returning to normal activities in one week.
Cardiac surgery is probably the most spectacular example of this enabling technology. Multiple centers in the United States and in Europe and Canada have performed mitral valve replacement, as well as CABG. Totally endoscopic coronary artery bypass is now being performed with as little as 2-day length of stay, with patients resuming their normal activities one week following surgery.
The greatest promise of computer-enhanced surgery lies in its future applications. Enhanced precision and flexibility and the ability to deliver highly functional instruments to small awkward locations will empower surgeons to develop new techniques that are not currently feasible with MIS techniques. Robotic surgery could very well stimulate a new evolution of surgery in the decade to follow, as the instrumentation evolves and more flexible platforms for instrument delivery are developed.
MULTIDISCIPLINARY PLENARY SESSION
8:30am Thursday, September 7, 2006
INNOVATIONS IN SURGERY AND MEDICINE: FROM THE BENCH TO THE BEDSIDE
How to Start and Bring Your Idea of
Surgical Instrument to Reality
Thomas J. Fogarty, MD
How to overcome the barriers to innovation, the resources, time and personnel involved in the invention process will be presented. Changes that we can directly influence, alliances we can create, and situations we must begin to influence will also be discussed.
Venture Side of Starting a Company and
What to Look for in an Idea
Leslie Bottorff, Venture Capitalist
This presentation includes an overview of how physician entrepreneurs might go about getting funding for their new company concept, including seeking capital from institutional venture capital investors. It includes an explanation of how the venture capital industry works, how firms obtain their funds, structure their investments, and what criterion they will use to evaluate whether to invest in a start-up company or concept. Also included will be some frameworks for evaluating the business potential for a product concept or innovation, and whether seeking venture capital to start a new company is a viable avenue for getting the concept from the bench to commercial viability.
MULTIDISCIPLINARY PLENARY SESSION
10:30am Thursday, September 7, 2006
INFORMATICS FOR THE LAPAROENDOSCOPIC SURGEON
Paul Alan Wetter, MD
SLS endeavors to improve patient care and promote the highest standards of practice through education, training, and information distribution. SLS provides a forum for the introduction, discussion and dissemination of new and established ideas, techniques and therapies in minimal access surgery.
A fundamental goal of SLS is ensuring that its members have access to the newest ideas and approaches, as rapidly as possible. SLS makes information available from national and international experts through its publications, videos, conferences, and other electronic media.
To meet this goal SLS is using advanced internet technologies, to provide information to members and their patients.
This presentation will include a short tour of the SLS internet resources and a behind the scenes look at the technology used to implement them. including: Member listing, online textbook resources, SLS journals online, use of Blog Engines and web based programs.
General Informatic Session—Electronic Medical Records, CPOE, HIPAA Compliance,
and Evidence Based Medicine
Gustavo Stringel, MD
Informatics for the Laparoendoscopic Surgeon.
Information and communication technology (ICT) has been the driving force behind rapid economic growth around the world. It is “transforming social and economic activity faster than the steam engine, railroads, and electricity did in earlier times.” - U.S. Agency for International Development (USAID).
This recent statement by the Agency for International Development summarizes the impact of information and communication technology. The health care industry and physicians have been slow to adopt ICT. There has been a love-hate relationship between physicians and information technology especially with the older generations. The rapid evolution of technology has made it difficult to keep pace with the changes. In terms of dealing with ICT one can quote Mohammed Ali “You can run but you can’t hide”. Sooner or later all Physicians must develop a sophisticated knowledge of ICT.
It is impossible for any physician to function without a computer. In the past few years, there has been no doctor’s office without a computer. It is known that most health organizations spend up to 40% of their capital budgets acquiring and updating information technology. Medical informatics was defined by Edward Shortliffe, “Medical Informatics is the rapidly developing scientific field that deals with the storage, retrieval, and optimal use of biomedical information, data and knowledge for problem solving and decision making.” It is imperative for the laparoendoscopic surgeon to develop the knowledge and expertise in this field in order to take advantage of the new era of the information age. There is virtually no aspect of medicine or health care that has not been affected by information technology. We now see Robots making rounds and dispensing medications. Since the inception of the newly designed PACs system (picture archiving and communication system), radiographs can be reviewed at home, on medical wards, in operating rooms and virtually in every place that has a computer connected to the internet
Evidence Based Medicine
The term “ evidence-based medicine" (EBM) has become part of every day clinical practice. It implies the use of current best evidence in making decisions about the care of individual patients. Patients’ treatment should be based, to the greatest extent possible, on evidence.
In the past, most medical decisions were based on clinical experience, guessing, folklore, tradition, non scientific clinical observations and the art of medicine. With evidence based medicine, it is imperative to have scientific validity (Rose Jeff). The availability of good and reliable information is essential for the practice of EBM.
The principles of EBM were stated in 1980, when the American Cancer Society (ACS) developed its guidelines for the cancer-related health checkup: “First, there must be good evidence that each test or procedure recommended is medically effective in reducing morbidity or mortality; second, the medical benefits must outweigh the risks; third, the cost of each test or procedure must be reasonable compared to its expected benefits; and finally, the recommended actions must be practical and feasible”.(Eddy, DM) Since then, many medical societies have developed guidelines for EBM.
Evidence Based Medicine was initially defined as opposite to clinical experience. The importance of complementing the clinical experience with better evidence is now emphasized. (Timmermans S, and Mauck, A) One common implementation is the use of clinical practice guidelines in decision making to improve outcomes. The Institute of Medicine (IOM) defines clinical guidelines as “systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances” (Field MJ and Lohr, KN)
Critics of clinical guidelines fear that its use and implementation will lead to “cookbook medicine” which will limit the use of practice experience and thwart clinical innovation.
Clinical guidelines have proliferated and there are currently guidelines for almost every disease, with more than 1000 new clinical guidelines created annually. Guideline implementation demands regular review of the scientific literature for necessary updates.
Computerized Physician Order Entry. CPOE
In 1999 the Institute of Medicine (IOM) reported in the article “To err is human,” that between 44,000 and 98,000 patients die in hospitals every year because of medical errors. In March 2001 the IOM released a second report on patient safety called “Crossing the Quality Chasm.” In summary, the IOM report stated that despite having the best acute medical services in the world, the overall U.S. care system is broken and fails to deliver consistent quality, especially for patients with chronic illness.
The IOM made several recommendations, including: creation of a center for patient safety, establishment of mandatory reporting via state agencies, establishment of safety programs in all health care organizations and passage of legislation.
In March 2003 the U.S. House of Representatives Ways and Means Committee passed the Safety Improvement Act by a wide margin. It stated that within 18 months the Secretary of Health and Human Services had to develop voluntary national standards for interoperability of health and information systems, specify medical terminology and evaluate technologies such as computerized physician order entry (CPOE) and medication bar coding,.
Adverse drug effects constitute about 19% of all adverse events, the second category after adverse surgical effects. Approximately 30 % of inpatients had at least one adverse drug effect.
Despite the potential benefits of CPOE, only an estimated 4-10% of U.S. hospital have fully implemented CPOE. (Cuttler DM, Feldman NE and Horwitz JR).
There has been increasing pressure from the IOM and other groups to implement CPOE. One of the main groups involved in the implementation of quality parameters including CPOE to improve quality and reduce error is The Leapfrog group. The Leapfrog group is a consortium of more than 130 fortune 500 companies and other large private and public purchasers of health care, including AT&T, IBM, General Electric and General Motors. They use their combined purchasing power to drive improvements in health care quality and safety. This group has continuously applied pressure to health providers to implement CPOE. In order to obtain Leapfrog certification a hospital must demonstrate that their CPOE system can intercept at least 50% of common serious medication prescribing errors.
There has been legislative pressure to implement CPOE. The state of California passed legislation for health care facilities to adopt a plan for reducing medication errors by 2005. In addition 26 other states have passed legislation to implement health care safety.
The potential savings of implementing CPOE have been emphasized mainly by reducing the number of medication errors. It has been calculated that there is an average cost of $4,685.00 per adverse drug event. CPOE should be recognized as a decision support tool. It can be effective only after a supportive system is implemented; this includes laboratory, pharmacy and dietary department integration. The human factor, not technology, is the main reason for failure. Physician participation and ownership of the project is essential for effective CPOE implementation.
The practice of medicine has significantly changed in the past ten years with an increase in the administrative and legal burdens for physicians. The managed care organizations change reimbursement and medical provider rules frequently. The physician has less time left to spend with the patient since there are increasing time demands for administration and bureaucracy. In the old times the physician’s main focus was treatment of the patient. Nowadays the paradigm has shifted to administrative issues, such as patient coverage, benefits, co-payments, formulary and non formulary medications, HIPAA compliance, referral authorization, and many others.
The Kassembaum-Kennedy Act of 1996, also known as The Health Insurance Portability and Accountability Act (HIPAA), was initially intended to simplify the overwhelming administrative processes and to improve health information security.
Many of the HIPAA regulations deal with simple administrative policies and procedures, such as securing patient privacy, locking office doors, training of personnel in patient privacy, and others. Some other requirements need managerial and technological solutions. Some of the issues initially designed to simplify problems have created sophisticated and expensive complexity for the health care provider.
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) prompted new Federal regulations which require physicians to ensure that they are protecting the privacy and security of patients' medical information and using a standard format when submitting electronic transactions, such as submitting claims to payers.
The HIPAA Privacy Standards require physicians to protect the privacy of patients' medical information. Physicians are required to control the ways in which they use and disclose patients' "protected health information." In addition, physicians are required to offer patients certain rights with respect to their information, such as the right to access and copying, the right to request amendments, and the right to request an accounting of their charges. Finally, physicians are required to have certain administrative protections in place (such as a Privacy Officer, staff training, and implementation of appropriate Policies and Procedures) to further protect the privacy of patients' information.
Although HIPAA does not require physicians to use electronic transactions, a related law, the Administrative Simplification Compliance Act, does impose such a requirement. The Administrative Simplification Compliance Act requires that all claims submitted to the Medicare program must be submitted in electronic form. The implication of this requirement is that because the claims are submitted electronically, they will also be required to comply with HIPAA.
Department of Health and Human Services
Office of the Secretary
45 CFR Parts 160 and 164
Standards for Privacy of Individually
Identifiable Health Information; Final Rule
Federal Register / Vol. 67, No. 157 / Wednesday, August 14, 2002 / Rules and Regulations
A. Statutory Background
Congress recognized the importance of protecting the privacy of health information given the rapid evolution of health information systems in the Health Insurance Portability and
Accountability Act of 1996 (HIPAA), Public Law 104–191, which became law on August 21, 1996. HIPAA’s Administrative Simplification provisions, sections 261 through 264 of the statute, were designed to improve the efficiency and effectiveness of the health care system by facilitating the electronic exchange of information with respect to certain financial and administrative transactions carried out by health plans, health care clearinghouses, and health care providers who transmit information electronically in connection with such transactions. To implement these provisions, the statute directed HHS to adopt a suite of uniform, national standards for transactions, unique health identifiers, code sets for the data elements of the transactions, security of health information, and electronic signature.
Health Insurance Portability and Accountability Act of 1996
Summary of Administrative Simplification Provisions
Standards for electronic health information transactions. Within 18 months of enactment, the Secretary of HHS is required to adopt standards from among those already approved by private standards developing organizations for certain electronic health transactions, including claims, enrollment, eligibility, payment, and coordination of benefits. These standards also must address the security of electronic health information systems.
Mandate on providers and health plans, and timetable. Providers and health plans are required to use the standards for the specified electronic transactions 24 months after they are adopted. Plans and providers may comply directly, or may use a health care clearinghouse. Certain health plans, in particular workers compensation, are not covered.
Privacy. The Secretary is required to recommend privacy standards for health information to Congress 12 months after enactment. If Congress does not enact privacy legislation within 3 years of enactment, the Secretary shall promulgate privacy regulations for individually identifiable electronic health information.
Pre-emption of State Law. The bill supersedes state laws, except where the Secretary determines that the State law is necessary to prevent fraud and abuse, to ensure appropriate state regulation of insurance or health plans, addresses controlled substances, or for other purposes. If the Secretary promulgates privacy regulations, those regulations do not pre-empt state laws that impose more stringent requirements. These provisions do not limit a State's ability to require health plan reporting or audits.
Penalties. The bill imposes civil money penalties and prison for certain violations.
Failure to comply with HIPAA can result in civil and criminal penalties (42 USC § 1320d-5).
Civil Penalties. Violations of the Administrative Simplification Regulations can result civil monetary penalties of $100 per violation, up to $25,000 per year.
Criminal Penalties. In June 2005, the U.S. Department of Justice (DOJ) clarified who can be held criminally liable under HIPAA. Covered entities and specified individuals, as explained below, whom "knowingly" obtain or disclose individually identifiable health information in violation of the Administrative Simplification Regulations face a fine of up to $50,000, as well as imprisonment up to one year. Offenses committed under false pretenses allow penalties to be increased to a $100,000 fine, with up to five years in prison. Finally, offenses committed with the intent to sell, transfer, or use individually identifiable health information for commercial advantage, personal gain or malicious harm permit fines of $250,000, and imprisonment for up to ten years.
Electronic Medical Records (EMR)
For many years physicians have used paper-based medical records. Some of the weaknesses of paper-based medical records are obvious and have become more evident in the information age. Paper-based medical records are often illegible because of poor penmanship. They are often ambiguous and contain incomplete information; the clinical data if often fragmented. In addition, paper records are not readily available and require large space for storage. Paper-based medical records are difficult to use to coordinate care, routinely measure quality or reduce medical errors.
Information technology is increasingly recognized as an important tool for improving patient safety and quality of care, and for promoting the practice of evidence-based medicine. Electronic medical records have a great potential for improving quality. Some of the benefits of electronic documentation are easy viewing, accurate and easy prescription and test ordering, and messaging. Other potential benefits of implementing EMR include: analysis and reporting to improve quality and efficiency, patient-directed functionality and billing, which can yield financial benefits through more complete capture of services provided, more defensible Medicare coding at higher coding levels, and reductions in data-entry staff.
Despite this potential for quality improvement few physician practices or health care facilities have embraced the use of Electronic Medical Records. There is increasing interest in EMR among physician groups. In a survey of 1,200 mostly solo/small physician groups, less than 13 percent of respondents said that their practice had EMRs. 32 percent expressed interest in EMRs, and half of these were "very interested." Clearly, the EMR is of growing importance for many physician practices.
Some of the barriers of EMR implementation include: high initial cost and uncertain financial benefits, high initial physician time investment, difficulties with technology, complementary changes and support, and problems with electronic data exchange. Other problems include: lack of incentive and physicians’ attitudes. The support and encouragement from physician champions is extremely important to successfully implement EMR.
MULTIDISCIPLINARY PLENARY SESSION
11:30am Thursday, September 7, 2006
COMPETENCY ISSUES AND ITS ASSESSMENT METRICS
A Scientific Basis for Measuring Surgical Skills Using Laparoscopic Simulation
Steve Dawson, MD
Although procedural simulation is becoming more widely accepted, it will remain outside the mainstream until performance measures are defined which will convince skeptics that learning is possible through medical simulation. Early studies have already shown the elements of validity in current, relatively primitive systems. However, in most simulators, defining metrics for medical simulation remains more of an art than a science.
This presentation will explain our scientific approach to metrics definition, exemplified by CELTS, our prototype Computer-Enhanced Laparoscopic Training System. Our method incorporates a standardized generic scoring system applicable to different laparoscopic trainers and tasks. Following extensive interviews with expert laparoscopic surgeons, the metrics were defined in an explicit way based on the relevant skills that a laparoscopic surgeon should master.
Operator feedback is provided through a 5-dof tracking device and software developed to perform real time analysis of the motion of actual laparoscopic instruments. Performance statistics are infinitely expandable as more users train on the system and can be accessed through a web browser.
This system has been validated in published studies [Surgical Endoscopy, 2006; 20(1): 104-112]. The results show that our metrics and scoring system represents a technically sound approach that can be easily incorporated into a training system, enabling standardized laparoscopic skills performance assessment across all levels of experience. Because of its task-independent design, this system is easily adapted to a variety of surgical tasks without software or system modifications, thus providing flexibility in objective skills assessment.
Objective Measures of Surgical Competency
Wm. LeRoy Heinrichs, MD, PhD
Criterion-based Technical Training for Surgeons
Wm. Leroy Heinrichs, MD, PhD1,2, Brian Lukoff3, Patricia Youngblood, PhD2, Richard Shavelson, PhD3, Parvati Dev, PhD2
With the SLS Ad Hoc Committee on Surgical Simulation: Richard M. Satava, MD5, Harrith M. Hasson, MD4, Elspeth M. McDougall, MD6, Camran Nezhat, MD,3 Paul Alan Wetter, MD7
Objective: The new paradigm in surgical education for basic skills training is using computer-based (manikin, augmented or virtual reality) simulators with embedded criteria to be achieved by students before performing surgery on patients. To establish training criteria, we have assessed the performance of basic technical surgical skills of 18 experienced laparoscopic surgeons recorded electronically in 26 basic skills modules selected in five commercially available, computer-based simulators.
Methods/Procedures: Quantitative data produced by the surgeons practicing repetitively during three one-half day sessions on each of five different simulators were collected in a Stanford IRB-approved study. Eight surgeons are generalists, six are gynecologists, and four are urologists; eleven are academic surgeons, and fifteen perform ≥ ten laparoscopic surgeries per month. Surgeons were randomly assigned to simulator stations (a total of 15 were provided by vendors) during each session. Each surgeon received a demonstration of the functioning of each module by a trained assistant who also logged the surgeon into and out of modules, using assigned participant numbers to assure anonymity. Demographic and opinion data were obtained to facilitate analysis. We developed proficiency score formulas for each module of the form b0 + b1X1 + b2X2 + . . . + bkXk, (1) where b0, b1, b2, . . ., bk are constants (called coefficients) and X1, X2, . . ., Xk are the measures (variables) recorded in the module. Assumptions in the development of the proficiency formulas are that the proficiency levels of experienced subjects is ≥ than 50, best performances do not exceed 100, and that proficiency should increase with practice.
Results: As expected, early practice attempts demonstrate a sharp learning curve and reduced variability among surgeons’ performance. In the third and subsequent practice attempts, performance scores improved little. Median scores and levels of 20, 40, 60, and 80 percent are provided for each module. Construct validity is examined with these data by comparing data for two of the modules from a convenience sample of less-experienced laparoscopic surgeons.
Conclusions: The mathematical method is simple, easily adjustable, and is applicable to the following simulators for which data are available: Lap Mentor (Simbionix), LapSim (Surgical-Science), LTS2000 ISM60 (RealSim), ProMIS (Haptica), and Surgical Sim (METI). Based upon this study, proficiency levels for training courses can now be specified objectively (and tentatively) by residency directors and by professional organizations for different levels of training or post-training assessment of technical performance. We say tentatively because experience with the proficiency scores will provide feedback as to reasonable levels of performance in practice, because none of the simulators were developed as an assessment instrument per se, and because future studies should map the link between performance on the simulator tasks and performance in surgery.
Department of Obstetrics–Gynecology, Stanford University1, Stanford University Medical Media and Information Technologies (Summit)2, School of Education, Stanford University3, RealSim4, Dept. Surgery, Univ. of Washington5, Dept. Urology, Univ. Calif.–Irvine6, Society of Laparoendoscopic Surgeons7
Predictive Validity of Simulation Performance in Operative Performance
Neal Seymour, MD
The demonstration of effectiveness of simulation training in residency curriculum presents challenges to educators. Predictive validity testing requires basic preliminary validation not only of the simulation system to be tested, but of the assessment methodology for the clinical task being trained. Clinical performance for some tasks is difficult to evaluate. Generally, part-task skills such as suturing are the most testable. Alternative approaches to determination of simulation-driven performance improvement include: A) The use of surrogate clinical environments for assessment such as animal OR, and B) longitudinal assessment of clinical performance to ascertain that peer-appropriate performance targets are being achieved. Multiple-observation within subject trials can demonstrate cause-effect relationships between simulation training and improvement in clinical performance and are practical to use during the course of formative training. However, these methods are vulnerable to bias and confounding factors that are more effectively controlled for in drug study-style randomized trials. Other practical considerations in assessment include the fidelity of the assessment methods, frequency of application, and cross-task applicability. At Baystate Medical Center, Springfield, MA, a system of educational program development focusing on computer-based simulation was implemented with separate efforts involving medical student clinical clerks and surgical residents. This system served as the testbed for a larger curriculum effort, also focusing on simulation as the principle teaching method. During the course of training, selected simulation methods were subjected to predictive validity testing by both randomized controlled trial, and within-subject trials. In addition, resident technical performance was tracked globally during all clinical cases with a web-based data gathering tool. These results all suggest that the simulation methods used are effective contributors to resident and student clinical skills. At present the ability to demonstrate clear influence of training on clinical performance with practical outcomes measures is limited. The development of appropriate clinical performance measures and the effort to apply these in connection with simulation training methods that will ensure the quality of the education process as well as the resulting clinical care.
Technical Skill—a Component of Surgical Performance
Harrith M. Hasson, MD
Competency in laparoscopic surgery involves three interdependent components: knowledge, technical skill and judgment. Knowledge & judgment are assessed with objective examinations. Technical skill is still being evaluated through subjective appraisal. Surgical performance is based on technical skill. However, lacking knowledge or good judgment an excellent technician can experience problems and complications. Technical skills are based on inherent abilities which determine the ultimate level of laparoscopic skills. Training and practice help surgeons realize their full potential within the constraints of their natural abilities. There are three levels of skill assessment/ training 1) Basic coordination exercises which assess inherent ability 2) Enabling skill/ task exercises duplicating surgical maneuvers: cannulation, clip application, cutting, camera navigation, ligation, suturing, knot tying and application of energy sources. 3) Simulation of entire laparoscopic procedures. Recent advances in human performance research have identified tools for objective measurement of innate abilities. General System Performance Theory states that to perform a given task successfully, the system (surgeon) must have sufficient resource availability (capacity) to execute the task. If the performance demands of the task are greater that the basic performance resources (BPRs) of the surgeon, the task cannot be successfully performed. BPRs defining laparoscopic abilities include: Simple visual hand response speed, visual information processing speed, visual spatial short term memory capacity and arm neuromotor channel capacity; the most common performance limiting factor. The performance of a laparoscopic task or exercise (real or simulated) is limited by the weakest BPR relative to the demands of the task or exercise. However, experts can compensate for relative deficiency in one BPR by relative surplus in another and end up performing the tasks successfully. Transfer of skills from VR simulators or Box Trainers to the OR has been confirmed in several studies. A new paradigm for surgical training is emerging: residents should be trained to skill proficiency criterion in the safe simulation environment before performing surgery on patients. Simulation practice should continue so as to consolidate & integrate gained skills within established repertoire. Practice helps to maintain proficiency over time. Surgical performance, a complex phenomenon involving dynamic interaction between the surgeon’s knowledge, technical skill and judgment can be evaluated objectively by reviewing unedited videotapes for errors & OSATS global rating scale. To assess technical skills, Reznick & Regehr modified the OSCE (Objective Structured Clinical Exam) into Objective Structured Assessment of Technical Skill (OSATS) Exam. A multi-station task-specific bell ringer exam where performance is assessed by 2 examiners with 2 tools: task-specific check list of relevant items (scored 0/1) and global rating scale of 7 dimensions of operative performance (scored 0 poor to 5 excellent). A system of reviewing unedited videotapes has been implemented by Japanese Urologists and initiated by American Gynecologists through the Accreditation Council for Gynecologic Endoscopy (ACGE). Dr. Matsuda is giving an update at this meeting. Information regarding the ACGE Expertise Recognition Program is available through http://www.accreditationcouncil.org. References on request.
FUTURE TECHNOLOGY SESSION
9:00am Saturday, September 9, 2006
BEYOND HUMAN EXPERIENCE: BREAKING BONDS OF “HUMAN” LIMITATIONS
Medicine in the Extreme: Adventures of an
Explorer in Extreme Environments
Kenneth Kamler, MD
Regenerative Medicine: New Approaches in Health Care for the 21st Century
Anthony Atala, MD
Patients suffering from diseased and injured organs may be treated with transplanted organs. However, there is a severe shortage of donor organs which is worsening yearly due to the aging population. Scientists in the field of regenerative medicine and tissue engineering apply the principles of cell transplantation, material science, and bioengineering to construct biological substitutes that will restore and maintain normal function in diseased and injured tissues. Therapeutic cloning, where the nucleus from a donor cell is transferred into an enucleated oocyte in order to extract pluripotent embryonic stem cells, offers a potentially limitless source of cells for tissue engineering applications. The stem cell field is also advancing rapidly, opening new options for therapy. We review recent advances that have occurred in regenerative medicine and describe applications of these new technologies that may offer novel therapies for patients with end-stage tissue and organ failure.
Robots and Emotional Expression
Human Simulation Robotics
This presentation will discuss the author's work creating humanlike robots, robot skin materials, and cognitive experiments that gauge human reaction to the robots. Humanoid robots more closely emulate the expressive behavior, personality and tissue composition of people than ever before. The trends related to these advances are not slowing; in fact, according to many metrics, the trends are accelerating. The presentation will discuss the short term and long-term implications of these technology trends, including development of new applications for medicine. Humanlike robotic technologies may offer many new tools for medical simulation, visualization, and therapies, some of which will be discussed in the talk. The presenter will also demonstrate the conversational Albert Einstein robot, featured on the cover of WIRED in January 06.