Judith M. Wong

Simulation-based trial of surgical-crisis checklists.

BACKGROUND Operating-room crises (e.g., cardiac arrest and massive hemorrhage) are common events in large hospitals but can be rare for individual clinicians. Successful management is difficult and complex. We sought to evaluate a tool to improve adherence to evidence-based best practices during such events. METHODS Operating-room teams from three institutions (one academic medical center and two community hospitals) participated in a series of surgical-crisis scenarios in a simulated operating room. Each team was randomly assigned to manage half the scenarios with a set of crisis checklists and the remaining scenarios from memory alone. The primary outcome measure was failure to adhere to critical processes of care. Participants were also surveyed regarding their perceptions of the usefulness and clinical relevance of the checklists. RESULTS A total of 17 operating-room teams participated in 106 simulated surgical-crisis scenarios. Failure to adhere to lifesaving processes of care was less common during simulations when checklists were available (6% of steps missed when checklists were available vs. 23% when they were unavailable, P<0.001). The results were similar in a multivariate model that accounted for clustering within teams, with adjustment for institution, scenario, and learning and fatigue effects (adjusted relative risk, 0.28; 95% confidence interval, 0.18 to 0.42; P<0.001). Every team performed better when the crisis checklists were available than when they were not. A total of 97% of the participants reported that if one of these crises occurred while they were undergoing an operation, they would want the checklist used. CONCLUSIONS In a high-fidelity simulation study, checklist use was associated with significant improvement in the management of operating-room crises. These findings suggest that checklists for use during operating-room crises have the potential to improve surgical care. (Funded by the Agency for Healthcare Research and Quality.).

Crisis Checklists for the Operating Room: Development and Pilot Testing

BACKGROUND Because operating room crises are rare events, failure to adhere to critical management steps is common. We sought to develop and pilot a tool to improve adherence to lifesaving measures during operating room crises. STUDY DESIGN We identified 12 of the most frequently occurring operating room crises and corresponding evidence-based metrics of essential care for each (46 total process measures). We developed checklists for each crisis based on a previously defined method, which included literature review, multidisciplinary expert consultation, and simulation. After development, 2 operating room teams (11 participants) were each exposed to 8 simulations with random assignment to checklist use or working from memory alone. Each team managed 4 simulations with a checklist available and 4 without. One of the primary outcomes measured through video review was failure to adhere to essential processes of care. Participants were surveyed for perceptions of checklist use and realism of the scenarios. RESULTS Checklist use resulted in a 6-fold reduction in failure of adherence to critical steps in management for 8 scenarios with 2 pilot teams. These results held in multivariate analysis accounting for clustering within teams and adjusting for learning or fatigue effects (11 of 46 failures without the checklist vs 2 of 46 failures with the checklist; adjusted relative risk = 0.15, 95% CI, 0.04-0.60; p = 0.007). All participants rated the overall quality of the checklists and scenarios to be higher than average or excellent. CONCLUSIONS Checklist use can improve safety and management in operating room crises. These findings warrant broader evaluation, including in clinical settings.

Patterns in neurosurgical adverse events and proposed strategies for reduction

Neurosurgery is a high-risk specialty currently undertaking the pursuit of systematic approaches to reducing risk and to measuring and improving outcomes. The authors performed a review of patterns and frequencies of adverse events in neurosurgery as background for future efforts directed at the improvement of quality and safety in neurosurgery. They found 6 categories of contributory factors in neurosurgical adverse events, categorizing the events as influenced by issues in surgical technique, perioperative medical management, use of and adherence to protocols, preoperative optimization, technology, and communication. There was a wide distribution of reported occurrence rates for many of the adverse events, in part due to the absence of definitive literature in this area and to the lack of standardized reporting systems. On the basis of their analysis, the authors identified 5 priority recommendations for improving outcomes for neurosurgical patients at a population level: 1) development and implementation of a national registry for outcome data and monitoring; 2) full integration of the WHO Surgical Safety Checklist into the operating room workflow, which improves fundamental aspects of surgical care such as adherence to antibiotic protocols and communication within surgical teams; and 3-5) activity by neurosurgical societies to drive increased standardization for the safety of specialized equipment used by neurosurgeons (3), more widespread regionalization and/or subspecialization (4), and establishment of data-driven guidelines and protocols (5). The fraction of adverse events that might be avoided if proposed strategies to improve practice and decrease variability are fully adopted remains to be determined. The authors hope that this consolidation of what is currently known and practiced in neurosurgery, the application of relevant advances in other fields, and attention to proposed strategies will serve as a basis for informed and concerted efforts to improve outcomes and patient safety in neurosurgery.

Patterns in neurosurgical adverse events: endovascular neurosurgery

As part of a project to devise evidence-based safety interventions for specialty surgery, the authors sought to review current evidence in endovascular neurosurgery concerning the frequency of adverse events in practice, their patterns, and current methods of reducing the occurrence of these events. This review represents part of a series of papers written to consolidate information about these events and preventive measures as part of an ongoing effort to ascertain the utility of devising system-wide policies and safety tools to improve neurosurgical practice. Based on a review of the literature, thromboembolic events appeared to be the most common adverse events in endovascular neurosurgery, with a reported incidence ranging from 2% to 61% depending on aneurysm rupture status and mode of detection of the event. Intraprocedural and periprocedural prevention and rescue regimens are advocated to minimize this risk; however, evidence on the optimal use of anticoagulant and antithrombotic agents is limited. Furthermore, it is unknown what proportion of eligible patients receive any prophylactic treatment. Groin-site hematoma is the most common access-related complication. Data from the cardiac literature indicate an overall incidence of 9% to 32%, but data specific to neuroendovascular therapy are scant. Manual compression, compression adjuncts, and closure devices are used with varying rates of success, but no standardized protocols have been tested on a broad scale. Contrast-induced nephropathy is one of the more common causes of hospital-acquired renal insufficiency, with an incidence of 30% in high-risk patients after contrast administration. Evidence from medical fields supports the use of various preventive strategies. Intraprocedural vessel rupture is infrequent, with the reported incidence ranging from 1% to 9%, but it is potentially devastating. Improvements in device technology combined with proper endovascular technique play an important role in reducing this risk. Occasionally, anatomical or technical difficulties preclude treatment of the lesion of interest. Reports of such occurrences are scant, but existing series suggest an incidence of 4% to 6%. Management strategies for radiation-induced effects are also discussed. The incidence rates are unknown, but protective techniques have been demonstrated. Many of these complications have strategies that appear effective in reducing their risk of occurrence, but development and evaluation of systematic guidelines and protocols have been widely lacking. Furthermore, there has been little monitoring of levels of adherence to potentially effective practices. Protocols and monitoring programs to support integrated implementation may be broadly effective.

Smart Stylet: The Development and Use of a Bedside External Ventricular Drain Image-Guidance System

Background: Placement accuracy of ventriculostomy catheters is reported in a wide and variable range. Development of an efficient image-guidance system may improve physician performance and patient safety. Objective: We evaluate the prototype of Smart Stylet, a new electromagnetic image-guidance system for use during bedside ventriculostomy. Methods: Accuracy of the Smart Stylet system was assessed. System operators were evaluated for their ability to successfully target the ipsilateral frontal horn in a phantom model. Results: Target registration error across 15 intracranial targets ranged from 1.3 to 4.6 mm (mean 3.1 mm). Using Smart Stylet guidance, a test operator successfully passed a ventriculostomy catheter to a shifted ipsilateral frontal horn 20/20 (100%) times from the frontal approach in a skull phantom. Without Smart Stylet guidance, the operator was successful 4/10 (40%) times from the right frontal approach and 6/10 (60%) times from the left frontal approach. In a separate experiment, resident operators were successful 2/4 (50%) times when targeting the shifted ipsilateral frontal horn with Smart Stylet guidance and 0/4 (0%) times without image guidance using a skull phantom. Conclusions: Smart Stylet may improve the ability to successfully target the ventricles during frontal ventriculostomy.

Intraoperative Cerebrospinal Fluid Leak in Extradural Spinal Tumor Surgery

Objective Patients with extradural spine tumors are at an increased risk for intraoperative cerebrospinal fluid (CSF) leaks and postoperative wound dehiscence due to radiotherapy and other comorbidities related to systemic cancer treatment. In this case series, we discuss our experience with the management of intraoperative durotomies and wound closure strategies for this complex surgical patient population. Methods We reviewed our recent single-center experience with spine surgery for primarily extradural tumors, with attention to intraoperative durotomy occurrence and postoperative wound-related complications. Results A total of 105 patients underwent tumor resection and spinal reconstruction with instrumented fusion for a multitude of pathologies. Twelve of the 105 patients (11.4%) reviewed had intraoperative durotomies. Of these, 3 underwent reoperation for a delayed complication, including 1 epidural hematoma, 1 retained drain, and 1 wound infection. Of the 93 uncomplicated index operations, there were a total of 9 reoperations: 2 for epidural hematoma, 3 for wound infection, 2 for wound dehiscence, and 2 for recurrent primary disease. One patient was readmitted for a delayed spinal fluid leak. The average length of stay for patients with and without intraoperative durotomy was 7.3 and 5.9 days, respectively, with a nonsignificant trend for an increased length of stay in the durotomy cases (p=0.098). Conclusion Surgery for extradural tumor resections can be complicated by CSF leaks due to the proximity of the tumor to the dura. When encountered, a variety of strategies may be employed to minimize subsequent morbidity.

Simulation-Based Trial of Surgical-Crisis Checklists

From the Department of Health Policy and Management, Harvard School of Public Health (A.F.A., A.M.B., J.M.W., S.R.L., W.R.B., J.E.Z., D.S.S., A.A.G.), and the Center for Surgery and Public Health (A.F.A., A.M.B., J.M.W., S.R.L., W.R.B., J.E.Z., A.A.G.), the Department of Anesthesiology, Perioperative, and Pain Medicine (A.F.A., A.M.B., D.L.H.), the Department of Neurosurgery ( J.M.W.), Simulation, Training, Research, and Technology Utilization System (STRATUS) Center for Medical Simulation (C.N.P., D.S.S.), and the Department of Surgery (A.F.A., D.S.S., A.A.G.), Brigham and Women’s Hospital — all in Boston; the University of Michigan Health Systems, Department of Neurosurgery, Ann Arbor ( J.E.Z.); and Boeing Aircraft, Seattle (D.J.B.). Address reprint requests to Dr. Gawande at Brigham and Women’s Hospital, 75 Francis St., Boston, MA 02115, or at agawande@partners.org.