Alexander F. Arriaga

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.).

Acellular human dermis implantation in 153 immediate two-stage tissue expander breast reconstructions: determining the incidence and significant predictors of complications.

Background: Little information exists on the incidence of complications after acellular human dermis implantation in two-stage tissue expander breast reconstruction. The purpose of this study was to evaluate the incidence of postoperative adverse events and identify significant predictors of complications in acellular human dermis tissue expander breast reconstruction. Methods: This study accrued all patients from January of 2004 through April of 2008 undergoing two-stage immediate tissue expander breast reconstruction using acellular human dermis. A total of 153 expanders were placed. Complications were assessed. Univariate and multivariate logistic regression modeling was performed. Comparison of complication rates using the traditional (non–acellular human dermis) technique from concurrent (2004 to 2008) and consecutive time periods (2001 to 2003) for 2910 and 1170 expanders, respectively, is provided. Results: A total of 153 expanders were implanted in 96 women: 39 unilateral and 57 bilateral. Eleven (7.2 percent) were removed due to infection (n = 5, 3.3 percent), exposure (n = 4, 2.6 percent), or patient preference (n = 2, 1.3 percent). Other complications included cellulitis (3.9 percent), seroma (7.2 percent), hematoma (2.0 percent), mastectomy flap necrosis (4.6 percent), and leak/failed expansion (0.0 percent); 92.8 percent were successfully expanded and exchanged for a permanent implant. Eleven seromas (7.2 percent) were identified; nine underwent aspiration. None of these resulted in infection or reconstructive failure. Univariate analysis revealed age, body mass index, axillary dissection, and postoperative chemotherapy to be associated with reconstructive failure (p < 0.05). Multivariate analysis revealed that age, body mass index, and axillary dissection are independent risk factors for developing complications (p < 0.05). Conclusion: Acellular human dermis is a useful adjunct for intraoperative pocket development in immediate tissue expander reconstruction but can result in an increased risk of complications, in particular, seroma and reconstructive failure.

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.

Postgame analysis: Using video-based coaching for continuous professional development

BACKGROUND The surgical learning curve persists for years after training, yet existing continuing medical education activities targeting this are limited. We describe a pilot study of a scalable video-based intervention, providing individualized feedback on intraoperative performance. STUDY DESIGN Four complex operations performed by surgeons of varying experience--a chief resident accompanied by the operating senior surgeon, a surgeon with less than 10 years in practice, another with 20 to 30 years in practice, and a surgeon with more than 30 years of experience--were video recorded. Video playback formed the basis of 1-hour coaching sessions with a peer-judged surgical expert. These sessions were audio recorded, transcribed, and thematically coded. RESULTS The sessions focused on operative technique--both technical aspects and decision-making. With increasing seniority, more discussion was devoted to the optimization of teaching and facilitation of the residents technical performance. Coaching sessions with senior surgeons were peer-to-peer interactions, with each discussing his preferred approach. The coach alternated between directing the session (asking probing questions) and responding to specific questions brought by the surgeons, depending on learning style. At all experience levels, video review proved valuable in identifying episodes of failure to progress and troubleshooting alternative approaches. All agreed this tool is a powerful one. Inclusion of trainees seems most appropriate when coaching senior surgeons; it may restrict the dialogue of more junior attendings. CONCLUSIONS Video-based coaching is an educational modality that targets intraoperative judgment, technique, and teaching. Surgeons of all levels found it highly instructive. This may provide a practical, much needed approach for continuous professional development.

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.

Protecting patients from an unsafe system: the etiology and recovery of intraoperative deviations in care.

Objective:To understand the etiology and resolution of unanticipated events in the operating room (OR). Background:The majority of surgical adverse events occur intraoperatively. The OR represents a complex, high-risk system. The influence of different human, team, and organizational/environmental factors on safety and performance is unknown. Methods:We video-recorded and transcribed 10 high-acuity operations, representing 43.7 hours of patient care. Deviations, defined as delays and/or episodes of decreased patient safety, were identified by majority consensus of a multidisciplinary team. Factors that contributed to each event and/or mitigated its impact were determined and attributed to the patient, providers, or environment/organization. Results:Thirty-three deviations (10 delays, 17 safety compromises, 6 both) occurred—with a mean of 1 every 79.4 minutes. These deviations were multifactorial (mean 3.1 factors). Problems with communication and organizational structure appeared repeatedly at the root of both types of deviations. Delays tended to be resolved with vigilance, communication, coordination, and cooperation, while mediation of safety compromises was most frequently accomplished with vigilance, leadership, communication, and/or coordination. The organization/environment was not found to play a direct role in compensation. Conclusions:Unanticipated events are common in the OR. Deviations result from poor organizational/environmental design and suboptimal team dynamics, with caregivers compensating to avoid patient harm. Although recognized in other high-risk domains, such human resilience has not yet been described in surgery and has major implications for the design of safety interventions.

A policy-based intervention for the reduction of communication breakdowns in inpatient surgical care: results from a Harvard surgical safety collaborative.

Objective: To develop and evaluate an intervention to reduce breakdowns in communication during inpatient surgical care. Background: Communication breakdowns are the second most common cause of avoidable surgical adverse events after technical errors. Methods: In a pre- and postintervention study, a random selection of patients on the surgical services of 4 teaching hospitals were observed according to 3 measures: (1) resident-attending communication of critical patient events (eg, transfer into the intensive care unit, unplanned intubation, cardiac arrest); (2) resident-attending notification regarding routine weekend patient status; and (3) frequency of weekend patient visits by an attending. All departments then developed and adopted a set of policy and education initiatives designed to increase prompt and consistent resident-attending communication (especially in critical events) and to improve regular attending visits with surgical patients. Specific reinforcement of the policies included a pocket information card for residents, as well as periodic reminders. Repeat audits of the surgical services were then conducted. Results: We reviewed information for 211 critical events and 1360 patients for the nature of resident and attending communication practices. After the intervention, the proportion of critical events not conveyed to an attending decreased from 33% (26/80) to 2% (1/47), and gaps in the frequency of attending notification of patient status on weekends were virtually eliminated (P < 0.0001); the proportion of weekend patients not visited by an attending for greater than 24 hours decreased by half (from 61% to 33%; P = 0.0002). Contact resulted in attending-led changes in patient management in one-third of cases. Conclusions: An intervention to improve surgical communication practices at 4 teaching hospitals led to significant reductions in potentially harmful communication breakdowns during inpatient care; significant alterations in patient management were noted in one-third of cases in which there was an adherence to recommended communication practices.

The better colectomy project: association of evidence-based best-practice adherence rates to outcomes in colorectal surgery.

Objective:To evaluate whether adherence to evidence-based best practices in colorectal surgery predicts improved postoperative outcomes. Summary and Background Data:Over a quarter of a million colon and rectal resections are performed annually in the United States. The average postoperative complication rate for these procedures approaches 30%. Methods:A panel of colorectal and general surgeons from 3 hospitals (1 academic medical center and 2 community hospitals) was assembled to ascertain a set of 37 evidence-based practices that they felt were the most pertinent to the evaluation and management of a patient undergoing a colorectal resection. Fifteen of these practices were classified as “key processes” for the prevention of complications. We then retrospectively reviewed medical records for 370 consecutive patients undergoing colorectal resection at these institutions. We evaluated the association of best-practice adherence to complications in the subset of patients with outcome data available through the American College of Surgeons National Surgical Quality Improvement Program. Results:Nonadherence rates exceeded 40% for 11 practices (including 2 key processes: avoidance of unnecessary blood transfusions and timely removal of central venous catheters). Among 198 patients with American College of Surgeons National Surgical Quality Improvement Program outcomes data, 38 (19%) experienced complications, of which 31 (82%) involved postoperative infection. Nonadherence to key-processes significantly predicted the occurrence of a complication (P = 0.002). Each additional process missed increased the odds of a postoperative complication by 60% (odds ratio: 1.6; 95% confidence interval: 1.2–2.2). Conclusions:Failures of adherence with best practices in colorectal surgery is associated with an increased occurrence of complications. This study merits further research to confirm that improvement in compliance with perioperative best practices will reduce complication rates significantly.

Communication practices on 4 harvard surgical services: A surgical safety collaborative

Background:Communication breakdowns between surgical residents and attending physicians in the pre- and postoperative setting are common contributors to patient injury. These communication transactions might offer an opportunity for safety improvement, but it remains unknown how often resident-attending communication fails, what the current level of attending involvement is, and how often attending input changes the plan for patient care. We conducted a prospective study at 4 Harvard teaching hospitals to address these issues. Methods:Three prospective data collection strategies were employed: (1) we randomly selected surgical services and queried residents for the occurrence of predefined critical patient events and the characteristics of attending communications that ensued, (2) on weekends, randomly selected patients were interviewed and their charts reviewed to identify the frequency of attending visitation and how such visits affected processes of care, and (3) on weekends, senior residents on randomly selected surgical services were queried regarding the occurrence of attending-resident discussion of patients in their care. Results:Of 80 critical patient events identified, 26 (33%) were not communicated to attending surgeons. Residents reported that, when contacted, all attending physicians were receptive to communication, whether they were the primary surgeon or providing cross-coverage. Although residents felt that attending contact was unnecessary for safe patient care in 61 (76%) of these events, discussions with attending physicians changed management in 33% (18/54) of cases in which they occurred. Attending surgeons were found to visit their patients on randomly selected weekend days 42% (n = 37) of the time, while 21% (n = 19) had not visited for 2 or greater days. When attending physicians visited patients, however, resident management was modified 46% (n = 36) of the time. Though residents frequently discussed patient management with attending physicians on randomly selected weekends, they failed to do so 16% (n = 58) of the time, which appeared to be related to service-specific variation (χ2 = 269, P < 0.0001). Conclusions:In the context of both critical patient events and routine patient care, residents often fail to obtain attending surgeons’ input for management decisions. These failures seem to derive more from residents’ perception of necessity than from attending physicians’ receptiveness or interest in being contacted. Once involved, attending physicians frequently modify residents management decisions. It seems, therefore, that there is significant potential for communication failure and information loss among our 4 institutions.

Deconstructing intraoperative communication failures.

BACKGROUND Communication failure is a common contributor to adverse events. We sought to characterize communication failures during complex operations. METHODS We video recorded and transcribed six complex operations, representing 22 h of patient care. For each communication event, we determined the participants and the content discussed. Failures were classified into four types: audience (key individuals missing), purpose (issue nonresolution), content (insufficient/inaccurate information), and/or occasion (futile timing). We added a systems category to reflect communication occurring at the organizational level. The impact of each identified failure was described. RESULTS We observed communication failures in every case (mean 29, median 28, range 13-48), at a rate of one every 8 min. Cross-disciplinary exchanges resulted in failure nearly twice as often as intradisciplinary ones. Discussions about or mandated by hospital policy (20%), personnel (18%), or other patient care (17%) were most error prone. Audience and purpose each accounted for >40% of failures. A substantial proportion (26%) reflected flawed systems for communication, particularly those for disseminating policy (29% of system failures), coordinating personnel (27%), and conveying the procedure planned (27%) or the equipment needed (24%). In 81% of failures, inefficiency (extraneous discussion and/or work) resulted. Resource waste (19%) and work-arounds (13%) also were frequently seen. CONCLUSIONS During complex operations, communication failures occur frequently and lead to inefficiency. Prevention may be achieved by improving synchronous, cross-disciplinary communication. The rate of failure during discussions about/mandated by policy highlights the need for carefully designed standardized interventions. System-level support for asynchronous perioperative communication may streamline operating room coordination and preparation efforts.