The Anesthesia Patient Safety Foundation (APSF) is pleased to report that it continues to attract outstanding applications for funding. The educational focus of the APSF includes innovative methods of education and training to improve patient safety, development of educational content with application to patient safety, and development of testing of educational content to measure and improve safe delivery of perioperative anesthetic care.
The application process continues with an electronic, online submission format that was introduced in 2005. The applications, as well as all the required attachments, are uploaded to the newly redesigned APSF website (dev2.apsf.org), a process that facilitates the application review by members of the Scientific Evaluation Committee, improves the timeliness of responses to queries, and facilitates transmission of reviewer feedback to the applicants. The Scientific Evaluation Committee members continue to modify and perfect the electronic application and review process.
This year, the Scientific Evaluation Committee is very pleased to report on several significant developments in the APSF Grant Program. The first is the total amount of funding that the APSF continues to award; this year, the APSF is committing a total of $668,484 to support research and educational projects dedicated to patient safety.
The second development is the continued funding of named awards, including the APSF/American Society of Anesthesiologists (ASA) President’s Endowed Research Award, utilizing funds from the APSF endowment account that was made possible by the generous financial support from ASA over the past 20+ years; the APSF/Covidien Research Award, supported by a generous partial ($100,000) grant from Covidien; the APSF/American Society of Anesthesiologists (ASA) Endowed Research Award ($150,000); the APSF/Eisai, Inc. Research Award, made possible by a $150,000 unrestricted grant from Eisai, Inc.; and the APSF/Research Award, sponsored entirely by a grant from the APSF.
In addition to the Clinical Research and Education and Training content that is the major focus of the funding program, the APSF continues to recognize the patriarch of what has become a patient safety culture in the United States and internationally, and one of the founding members of the foundation—Ellison C. “Jeep” Pierce, Jr., MD. The APSF Scientific Evaluation Committee continues to designate each year one of the funded proposals as the recipient of this prestigious nomination, the Ellison C. Pierce, Jr. , MD, Research Award. The selected nomination carries with it an additional, unrestricted award of $5,000.
The APSF also has awarded The Doctors Company Foundation Ann S. Lofsky, MD, Research Award. This award is made possible by a $5,000 grant from The Doctors Company Foundation that will be awarded annually for a total of 5 years to a research project deemed worthy of the ideals and dedication exemplified by Dr. Ann S. Lofsky. Dr. Lofsky was a regular contributor to the APSF Newsletter, a special consultant to the APSF Executive Committee, and a member of the APSF Board of Directors. Her untimely passing cut short a much-valued and meaningful career as an anesthesiologist and as a dedicated contributor to anesthesia patient safety. It is the hope of the APSF that this award will inspire others toward her ideals and honor her memory.
For the year 2010 (projects to be funded starting January 1, 2010), 5 grants were selected for funding by the APSF Scientific Evaluation Committee (for names of committee members, please refer to the list in this issue). The APSF Scientific Evaluation Committee members were pleased to note that they reviewed a total of 32 applications in the first round, 12 of which were selected for final review at the American Society of Anesthesiologists (ASA) Annual Meeting in New Orleans, LA. As in previous years, the grant submissions addressed areas of high priority in clinical anesthesia. The major goal of the APSF funding is to stimulate the performance of studies that lead to prevention of mortality and morbidity due to anesthesia mishaps. A particular priority continues to be given to studies that address anesthetic problems in healthy patients, and to those studies that are broadly applicable and promise improved methods of patient safety with a defined and direct path to implementation into clinical care. Additionally, the APSF is encouraging the study of innovative methods of education and training to improve patient safety, and methods for the detection and prevention of medication errors.
The APSF Scientific Evaluation Committee convened during the ASA Annual Meeting on October 17, 2009, in New Orleans for final evaluation and selection of the proposals. Of the 12 finalists, the members of the APSF Scientific Evaluation Committee selected the following 5 applications:
Richard H. Blum, MD
Dr. Blum’s Education and Training submission is entitled “Assessing Performance of First Year Anesthesia Residents to Ensure Minimum Competence.”
Background: Evaluation of anesthesia resident performance is a common challenge for academic anesthesia programs; there is frequent concern that some trainees graduate from programs not having attained what is perceived to be minimum anesthesia competency. Although patient safety is primarily a problem of flawed systems, there are some physicians who are the primary cause of adverse events due to a lack of sufficient skills within their specialty; this shortcoming in education and training must be addressed in order to gain the trust of patients and the public.
Aims: This study plans to improve patient safety by building on an ongoing pilot research study to develop an effective, credible, ongoing, simulation-enabled assessment to more reliably identify anesthesia residents at an early stage of training who may not have attained sufficient skills. Early intervention is more likely to have a positive impact on attaining proficiency or directing residents toward another specialty with the goal of ensuring that no under-performing resident graduates from a residency program. Pilot data have identified critical cognitive and behavioral competencies (as opposed to basic anesthesia skills and tasks) via a modified Delphi study of an expert consensus panel; a simulation-based assessment has been developed to evaluate these competencies within a wide spectrum of anesthesia settings targeted to inexperienced CA-1 residents. This study plans to build on data and experience from the pilot study to improve psychometric variables including reliability and validity of the simulation-based assessment tool. The main psychometric outcome variable will be to demonstrate construct validity by showing a statistically significant difference in assessment scores between an inexperienced CA-1 cohort and an experienced CA-3 cohort. The key to success will be the ability to reliably and reproducibly transfer the assessment process to 2 hospital-based simulation programs. Extension to these hospital simulation programs is critical to the feasibility of increasing subjects and moving toward a multi-hospital based summative assessment program that is ongoing and sustainable. Carefully trained anesthesia faculty will confidentially and systematically rate assessment data. Use of an on-line audio video database system will allow safe storage of confidential data and provide the ability to do on-line asynchronous ratings.
Implications: The investigators foresee this work potentially leading to standards and criteria that can be adapted at other academic anesthesia training programs as well as different medical specialties, having significant potential to enhance patient safety on a large scale.
In addition to receiving the requested funding of $150,000 for his project, Dr. Blum’s application was designated as the APSF/American Society of Anesthesiologists (ASA) President’s Endowed Research Award. Dr. Blum is also the recipient of the Ellison C. Pierce, Jr., MD, Research Award, which consists of an additional, unrestricted award of $5,000.
Ashraf S. Habib, MB, Bch
Dr. Habib’s Clinical Research project is entitled “Computerized Surveillance of Opioid-Related Adverse Drug Events in the Perioperative Period.”
Background: Opioid-induced respiratory depression can cause morbidity and mortality in surgical patients. While some risk factors are identified, there remains a subset of healthy patients who experience unpredictable life-threatening opioid-induced events. This indicates that there are other risk factors not yet identified that might include unrecognized patient factors, interactions with sedative agents, or genetic factors that increase the risk of adverse events. Recognition of patients at increased risk for respiratory depression could significantly improve patient safety by allowing health care providers to tailor the anesthetic plan, postoperative analgesia regimen, and discharge location to account for an increased risk for opioid induced respiratory depression.
Aims: To identify those risk factors, the investigators plan to perform a matched case control study. Patients who have received naloxone will be identified using a computerized surveillance system. This system delivers an electronic, daily report on all triggers activated, which are then evaluated the following day for causality and severity. If an episode of opioid-induced respiratory depression is confirmed, the patient will be consented to participate in the study involving collection of information about comorbidities and medications used, as well as collection of blood samples for analysis of known genetic polymorphisms involving the opioid mu receptor and the CYP2D6 enzyme. Controls matched by age, gender, ethnicity and type of surgery will be prospectively enrolled in a 2:1 ratio.
Implications: With approximately 19,000 surgeries and 127 events of opioid-induced respiratory depression per year, this research will very likely lead to recognition of important risk factors that can significantly improve the safety of patients in the perioperative period.
In addition to receiving the requested funding of $149,999 for his project, Dr. Habib’s application was designated as the APSF/Covidien Research Award, made possible by an unrestricted, partial $100,000 grant from Covidien.
Guy L. Weinberg, MD
Dr. Weinberg’s Education and Training project is entitled “Developing an Educational Tool for Managing Local Anesthetic Systemic Toxicity.”
Background: Local anesthetics are exceedingly useful for providing perioperative anesthesia and analgesia. However, this utility is limited by their potential for causing severe neurological or cardiac toxicity following systemic absorption or unintended intravascular injection. Local anesthetic systemic toxicity (LAST), a much-feared and potentially fatal complication of regional anesthesia, is nonetheless reversible with appropriate treatment.
Aims: The investigators propose to create an instructional training module to improve physician understanding of LAST, focusing on its prevention, diagnosis and treatment. The investigators will develop the educational content in collaboration with experts in LAST and representatives of the American Society of Regional Anesthesia and Pain Medicine (ASRA). The educational design and assessment tools will be developed in collaboration with experts in medical education at the University of Illinois at Chicago, Department of Medical Education. The educational module will be piloted and assessed with anesthesiology residents and staff at the University of Illinois at Chicago Medical Center. After review of the pilot outcomes and addressing of any final revisions recommended by the LAST advisory committee, the definitive educational toolkit for the training module will be distributed to all anesthesia departments in both academic and non-academic anesthesia programs throughout the country. The toolkit will also contain a faculty development component for workshop facilitators that will make implementation of the LAST prevention and treatment workshop simple and easy to use within their own anesthesia departments. The investigators will also provide a faculty development workshop and distribute toolkits to participants at the 2011 ASA and ASRA annual meetings.
Implications: This educational tool intends to improve patient safety by helping anesthesiology program directors implement the LAST training module that will reduce the incidence, morbidity, and mortality of local anesthetic systemic toxicity.
In addition to receiving the requested funding of $150,000 for the project, Dr. Weinberg’s application was designated as the APSF/American Society of Anesthesiologists (ASA) Endowed Research Award, made possible by an unrestricted, $150,000 grant from the American Society of Anesthesiologists. Dr. Weinberg is also the recipient of
The Doctor’s Company Foundation Ann S. Lofsky, MD, Research Award, which consists of an additional, unrestricted grant of $5,000.
Marcin Wasowicz, MD
Dr. Wasowicz’s Clinical Research project is entitled “The Association Between Platelet Inhibition and Perioperative Major Adverse Cardiac Events in Post-Percutaneous Coronary Intervention Patients Undergoing Non-Cardiac Surgery.”
Background: In post-coronary intervention patients undergoing non-cardiac surgery (NCS), inadequate platelet inhibition is an independent predictor of major adverse cardiac events (MACE). Long-term anti-platelet treatment is required after a successful percutaneous coronary intervention (PCI). About 5% of patients will undergo NCS within 1 year after intracoronary stenting. Physicians are increasingly confronted with the challenge of appropriate perioperative management of patients who underwent PCI with stent implantation, and are scheduled for NCS. The dilemma of handling the anti-platelet therapy during the perioperative period involves balancing the risk of increased blood loss when anti-platelet agents are continued during the perioperative period, with the risk of MACE due to stent thrombosis if anti-platelet therapy is stopped prior to the surgery. The average perioperative complication rate of these patients is as high as 45%, and the mortality rate is 20-83%. Strong supporting evidence is lacking for the preferred perioperative anti-platelet therapy for patients who previously had stent implantation. Recently published recommendations were based mainly on the cardiology literature and expert opinions.
Aims: The study will investigate the independent relationship between platelet function and MACE during the perioperative period. This will be accomplished by measuring platelet inhibition during the perioperative period (before and after surgery) in post-PCI patients undergoing NCS who are taking anti-platelet medications. The investigation is designed as a prospective, multi-center observational study. Recruitment will involve patients who underwent PCI, receive anti-platelet therapy, and are scheduled for NCS. Patients will be assessed for the presence of MACE during their hospital stay. Thromboelastography (TEG) and Platelet Mapping Assay (PMA) will be used to measure platelet inhibition before and after surgery. These methods are validated point-of-care (POC) measurements. In addition to platelet inhibition, 4 covariates will be included in the model: type of stent, time between PCI and NCS, mono- or dual-therapy (aspirin or aspirin plus Plavix), and urgent surgery.
Implications: The incidence of MACE in post-PCI patients undergoing NCS is very high, while current perioperative management is based on experts’ opinions and recommendations. The results of this study will help us understand the pathophysiology of MACE and guide anti-platelet therapy to decrease the incidence of MACE in the studied group of patients. If inadequate platelet inhibition is an independent predictor of MACE, then it is highly likely that identifying and enhancing anti-platelet therapy in this high-risk group will lead to improved outcomes.
In addition to receiving the requested funding of $147,835 for his project, Dr. Wasowicz’s application was designated as the APSF / Eisai, Inc. Research Award, made possible by an unrestricted, $150,000 grant from Eisai, Inc.
Stuart McCluskey, MD
Dr. McCluskey’s Education and Training proposal is entitled “Virtual Anesthesia: An Online Simulation of Intraoperative Hemodynamic Management in Major Surgical Procedures.”
Background: The use of simulation as an adjunct to the training of anesthesiologists has a long history, beginning in 1969. This tool for training and evaluation of skills in anesthesia can broadly be divided into the use of mannequin-based simulations that employ a dummy in a realistic replication of the operating room (OR) environment, and screen-based simulations that rely only on a personal computer. The key advantage of mannequin-based systems is the ability to simulate complex interactions and communication between the members of the OR team during adverse events, which has been termed Crisis Resource Management (CRM). However, high-fidelity simulators are not without drawbacks. They are expensive to acquire, and require an extensive infrastructure of space and personnel to operate them. This limits the number of simulators an institution can provide, which in turn restricts the availability of simulators for students to engage in “deliberate practice.” Facilitators also must also be trained for the complex debriefing that is an essential part of the simulation exercise.
Aim: The objective of this project is to create a new web-based simulation of patients undergoing surgery (Virtual Anesthesia) to provide an opportunity for trainees in anesthesia to exercise their skills in the intraoperative hemodynamic management of surgical patients. This will provide a safe environment to practice diagnosing and treating problems that the trainees will encounter in managing real future surgical cases. Feedback will be provided at the end of each case, with an overall score reflecting the trainees’ success in managing the case, and a debriefing describing the items used in calculating the score. Practice in a simulated environment will improve trainees’ comfort level and reduce the initial stress when they encounter these problems in the OR. The simulation will be evaluated by assessing the face and content validity, the usability and the construct validity. Construct validity will be determined by measuring the scores obtained by novice, intermediate, and expert users, and by measuring the improvement in scores with repeated practice in managing simulated cases. Virtual Anesthesia will use a mathematical model of the circulation, which simulates some of the cardiovascular complications that can arise during surgery, including depressed myocardial contractility, myocardial infarction, arrhythmias, hypothermia, fever, hypo- and hypertension, hypervolemia, bleeding and hypovolemia, as well as abnormalities in hematocrit and serum electrolytes.
Implications: Once developed, the Virtual Anesthesia will be provided as a free educational resource for teaching hospitals around the world, encouraging trainees to engage in a virtual practice with a variety of problems and degrees of difficulty. Virtual Anesthesia can also be used by medical educators as a focus for group discussions, or as a teaching aid in the classroom.
In addition to receiving the requested funding of $70,650 for his project, Dr. McCluskey’s application was designated as the APSF Research Award, made possible by an unrestricted grant from APSF.
On behalf of APSF, the members of the Scientific Evaluation Committee wish to congratulate all of the investigators who submitted their work to the APSF, whether or not their proposals were funded. The Committee members hope that the high quality of the proposals, the significant amount of resources offered by the APSF, and the important findings that will undoubtedly result from completion of these projects will serve as a stimulus for other investigators to submit research grants that will benefit all patients and our specialty.
Dr. Brull is the Chair of the APSF Scientific Evaluation Committee.