Douglas S. Smink

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.

Pilot testing of a model for insurer-driven, large-scale multicenter simulation training for operating room teams.

Objective:To test the feasibility of implementing a standardized teamwork training program with full operating room teams in multiple institutions, driven by malpractice insurer support and incentives. Background:Failures in intraoperative teamwork are among the leading causes of preventable patient injury and death in surgical patients. Teamwork training, particularly using simulation, can be an effective intervention but is difficult to scale. Methods:A malpractice insurer convened a collaborative with 4 Harvard-affiliated simulation programs to develop a standardized operating room teamwork training curriculum, including principles of communication, assertiveness, and use of the World Health Organization Surgical Safety Checklist. Participant teams were compensated for lost operative time via malpractice premium discounts, continuing education credits, and compensation for lost wages. The course was delivered through a simulation program involving the management of intraoperative emergency scenarios. Participants were surveyed for their perceptions of the program and of its impact on clinical practice. Results:A total of 221 active operating room staff members participated in the program. Each team contained at least 1 attending surgeon, 1 attending anesthesiologist, and 1 operating room nurse (mean size per team: 7 ± 2 participants). No study dates were cancelled because of lack of attendance. The survey response rate was 99% (218/221). Overall, the vast majority of participants found the scenarios realistic [94% (95% confidence interval: 90.9%, 97.2%)], appropriately challenging [95.4% (92.6%, 98.2%)], relevant to their practice [96.3% (93.8%, 98.8%)], and found the training would help them provide safer patient care [92.6% (89.1%, 96.1%)]. Surgeons reported their greatest personal deficit as communication skills. Operating room nurses and anesthesiologists reported a greater need than surgeons to work on personal assertiveness. Conclusions:A standardized multicenter team training program involving full operative teams is feasible with high-fidelity simulation and modest compensation for lost time. The vast majority of the multidisciplinary participants believed the course to have had a meaningful impact on their approach to clinical practice.

Management of biliary tract disease during pregnancy: a decision analysis

BackgroundThe appropriate management of biliary tract disease during pregnancy is uncertain. Although laparoscopic cholecystectomy can be performed safely during pregnancy, the timing and indications for this surgical intervention have not been firmly established.MethodsWe constructed a Markov decision analytic model that incorporates maternal well-being and fetal outcome into a choice between nonoperative management (NM) and laparoscopic cholecystectomy (LC) for pregnant women with biliary tract disease (BTD). Our model cycles through weeks of pregnancy for a cohort of 200 gravid women presenting with biliary tract disease in both the first and second trimesters. Weekly state probabilities and utilities for fetal outcome were derived from the literature, while weekly utilities for disease and operative states were estimated in consultation with obstetricians. We cycled the model from 6 to 42 weeks and from 19 to 42 weeks to simulate first and second trimester presentations. Outcomes are expressed in quality pregnancy weeks (QPWs). One QPW is the utility of a normal healthy week of pregnancy.ResultsA comprehensive search of the literature yielded a fetal death rate following LC for biliary tract disease of 2.2% and following NM of 7%. Relapse rates were found to be trimester dependent and estimated to be 55%, 55%, and 40% in the first, second, and third trimester, respectively. For a hypothetical cohort of 100 women presenting with biliary tract disease in their first trimester, LC generated 12,800 QPWs compared with 12,400 QPWs for NM, an average gain of 4 QPWs per woman. For the cohort of women entering the model in the second trimester, 11,600 QPWs were accrued by the LC group and 11,400 QPWs by the NM group, an average gain of 2 QPWs per woman. These findings were sensitive only to changes in fetal death rates under the two treatment arms.ConclusionsLaparoscopic cholecystectomy is superior to nonoperative management for pregnant women presenting in the first or second trimester with biliary tract disease.

Access to emergency operative care: a comparative study between the Canadian and American health care systems.

BACKGROUND Canada provides universal health insurance to all citizens, whereas 47 million Americans are uninsured. There has not been a study comparing access to emergency operative care between the 2 countries. As both countries contemplate changes in health care delivery, such comparisons are needed to guide health policy decisions. The purpose of this study is to determine whether or not there is a difference in access to emergency operative care between Canada and the United States. METHODS All patients diagnosed with acute appendicitis from 2001 to 2005 were identified in the Canadian Institute for Health Information database and the US Nationwide Inpatient Sample. Severity of appendicitis was determined by ICD-9 codes. Patients were further characterized by age, gender, insurance status, race, and socioeconomic status (SES; income). Univariate and multivariate analyses were performed to determine the odds of appendiceal perforation at different levels of SES in each country. RESULTS There were 102,692 Canadian patients and 276,890 American patients with acute appendicitis. In Canada, there was no difference in the odds of perforation between income levels. In the United States, there was a significant, inverse relationship between income level and the odds of perforation. The odds of perforation in the lowest income quartile were significantly higher than the odds of perforation in the highest income bracket (odds ratio, 1.20; 95% confidence interval, 1.16-1.24). CONCLUSION The results suggest that access to emergency operative care is related to SES in the United States, but not in Canada. This difference could result from the concern over the ability to pay medical bills or the lack of a stable relationship with a primary care provider that can occur outside of a universal health care system.

Outpatient Cholecystectomy at Hospitals Versus Freestanding Ambulatory Surgical Centers

BACKGROUND Because of safety concerns, some payers do not reimburse for laparoscopic cholecystectomy performed in freestanding ambulatory surgical centers (ASCs). This policy has been controversial because of increasing competition between ASCs and hospitals for low risk surgical patients. STUDY DESIGN We performed a retrospective cohort study of patients undergoing elective outpatient laparoscopic cholecystectomy in the state of Florida in 2002 and 2003 (n=40,040), using the Agency for Healthcare Research and Quality State Ambulatory Surgery Database. Patients treated in hospitals and ASCs were compared with respect to patient characteristics, charges, outcomes, and processes of care. RESULTS For both hospital-based and ASC-based laparoscopic cholecystectomy patients, greater than 99% were successfully discharged home, and there were no reported deaths. Compared with those treated in hospitals, patients in ASCs had a higher rate of intraoperative cholangiogram (39% versus 36%, p=0.008). There was no difference in the proportion of procedures converted to open cholecystectomy. ASC-based patients were slightly younger (mean age 45 years versus 49 years, p < 0.001), were less often diagnosed with acute cholecystitis (4.8% versus 8.3%, p < 0.001), and had fewer comorbidities on average than hospital-based patients, but both cohorts had few comorbidities overall (99% had Charlson scores of 0 or 1). ASC patients were more likely to be Caucasian (86% versus 75%, p < 0.001) and were more likely to have private insurance (92% versus 67%, p < 0.001). For patients who had ambulatory laparoscopic cholecystectomy as the only procedure, the median charges were

The Feasibility of Real-Time Intraoperative Performance Assessment With SIMPL (System for Improving and Measuring Procedural Learning): Early Experience From a Multi-institutional Trial

6,028 at ASCs, compared with

Utilization of laparoscopic and open inguinal hernia repair: a population-based analysis.

10,876 at hospitals. CONCLUSIONS In a population of slightly younger, healthier patients, laparoscopic cholecystectomy in freestanding ASCs appears to be performed safely and with substantially lower charges than in hospitals.

Prophylactic Antibiotics and Prevention of Surgical Site Infections

PURPOSE Intraoperative performance assessment of residents is of growing interest to trainees, faculty, and accreditors. Current approaches to collect such assessments are limited by low participation rates and long delays between procedure and evaluation. We deployed an innovative, smartphone-based tool, SIMPL (System for Improving and Measuring Procedural Learning), to make real-time intraoperative performance assessment feasible for every case in which surgical trainees participate, and hypothesized that SIMPL could be feasibly integrated into surgical training programs. METHODS Between September 1, 2015 and February 29, 2016, 15 U.S. general surgery residency programs were enrolled in an institutional review board-approved trial. SIMPL was made available after 70% of faculty and residents completed a 1-hour training session. Descriptive and univariate statistics analyzed multiple dimensions of feasibility, including training rates, volume of assessments, response rates/times, and dictation rates. The 20 most active residents and attendings were evaluated in greater detail. RESULTS A total of 90% of eligible users (1267/1412) completed training. Further, 13/15 programs began using SIMPL. Totally, 6024 assessments were completed by 254 categorical general surgery residents (n = 3555 assessments) and 259 attendings (n = 2469 assessments), and 3762 unique operations were assessed. There was significant heterogeneity in participation within and between programs. Mean percentage (range) of users who completed ≥1, 5, and 20 assessments were 62% (21%-96%), 34% (5%-75%), and 10% (0%-32%) across all programs, and 96%, 75%, and 32% in the most active program. Overall, response rate was 70%, dictation rate was 24%, and mean response time was 12 hours. Assessments increased from 357 (September 2015) to 1146 (February 2016). The 20 most active residents each received mean 46 assessments by 10 attendings for 20 different procedures. CONCLUSIONS SIMPL can be feasibly integrated into surgical training programs to enhance the frequency and timeliness of intraoperative performance assessment. We believe SIMPL could help facilitate a national competency-based surgical training system, although local and systemic challenges still need to be addressed.

A multi-institutional study of the emotional intelligence of resident physicians

BACKGROUND Laparoscopic inguinal hernia repair is a safe, effective treatment for inguinal hernias and is considered, by some, to be the procedure of choice for recurrent inguinal hernias. Little is known, however, about the frequency with which laparoscopic inguinal hernia repair is performed and the determinants of its utilization. METHODS We performed a retrospective cohort study of all patients undergoing outpatient inguinal hernia repairs in Florida in 2002 and 2003, using the AHRQ State Ambulatory Surgery Database. We compared patient demographics, indication for procedure, location of procedure (i.e., hospital or ambulatory surgery center), and charges for laparoscopic and open repairs. RESULTS Of 58,172 outpatient inguinal hernia repairs, 11,351 (19.5%) were performed laparoscopically. In the subset of 6221 recurrent inguinal hernias, only 1276 (20.5%) were performed laparoscopically. Patients undergoing a laparoscopic repair were younger (52.7 versus 57.4 years; P < 0.001), more likely to be of the white race (84.4 vs. 79.3%; P < 0.001), and more likely to have private insurance (62.0 versus 47.2%; P < 0.001), compared to those undergoing open repair. Laparoscopic repairs resulted in higher charges than open repairs (