Using the Operating Room Black Box to Assess Surgical Team Member Adaptation Under Uncertainty: An Observational Study.

OBJECTIVE: Identify how surgical team members uniquely contribute to teamwork and adapt their teamwork skills during instances of uncertainty. BACKGROUND: The importance of surgical teamwork in preventing patient harm is well documented. Yet, little is known about how key roles (nurse, anesthesiologist, surgeon, and medical trainee) uniquely contribute to teamwork during instances of uncertainty, particularly when adapting to and rectifying an intraoperative adverse event (IAE). METHODS: Audiovisual data of 23 laparoscopic cases from a large community teaching hospital were prospectively captured using OR Black Box. Human factors researchers retrospectively coded videos for teamwork skills (backup behavior, coordination, psychological safety, situation assessment, team decision-making, and leadership) by team role under 2 conditions of uncertainty: associated with an IAE versus no IAE. Surgeons identified IAEs. RESULTS: In all, 1015 instances of teamwork skills were observed. Nurses adapted to IAEs by expressing more backup behavior skills (5.3× increase; 13.9 instances/hour during an IAE vs 2.2 instances/hour when no IAE) while surgeons and medical trainees expressed more psychological safety skills (surgeons: 3.6× increase; 30.0 instances/hour vs 6.6 instances/hour and trainees: 6.6× increase; 31.2 instances/hour vs 4.1 instances/hour). All roles expressed fewer situation assessment skills during an IAE versus no IAE. CONCLUSIONS: OR Black Box enabled the assessment of critically important details about how team members uniquely contribute during instances of uncertainty. Some teamwork skills were amplified, while others dampened when dealing with IAEs. The knowledge of how each role contributes to teamwork and adapts to IAEs should be used to inform the design of tailored interventions to strengthen interprofessional teamwork.

Surgeons' Leadership Style and Team Behavior in the Hybrid Operating Room: Prospective Cohort Study.

OBJECTIVE: This study aimed to assess the relationship between surgeons' leadership style and team behavior in the hybrid operating room through video coding. Secondly, possible fluctuations possible fluctuations in leadership styles and team behavior during operative phases were studied. BACKGROUND: Leadership is recognized as a key component to successful team functioning in high-risk industries. The 'full range of leadership' theory is commonly used to evaluate leadership, marking transformational, transactional, and passive. Few studies have examined the effects of these leadership styles on team behavior in surgery and/or their fluctuations during surgery. METHODS: A single-center study included patients planned for routine endovascular procedures. A medical data capture system was used to allow post hoc video coding through Behavior Anchored Rating Scales. Multilevel statistical analysis was performed to assess possible correlations between leadership style and 3 team behavior indicators (speaking up, knowledge sharing, and collaboration) on an operative phase level. RESULTS: Twenty-two cases were analyzed (47 hours recording). Transformational leadership is positively related to the extent to which team members work together (γ=0.20, P <0.001), share knowledge (γ=0.45, P <0.001), and speak up (γ=0.64, P <0.001). Passive leadership is significantly positively correlated with speaking up (γ=0.29, P =0.004). Leadership style and team behavior clearly fluctuate during a procedure, with similar patterns across different types of endovascular procedures. CONCLUSIONS: Consistent with other professional fields, surgeons' transformational leadership enhances team behavior, especially during the most complex operative phases. This suggests that encouraging surgeons to learn and actively implement a transformational leadership style is meaningful to enhance patient safety and team performance.

Cognitive biases in surgery: systematic review.

BACKGROUND: Although numerous studies have established cognitive biases as contributors to surgical adverse events, their prevalence and impact in surgery are unknown. This review aimed to describe types of cognitive bias in surgery, their impact on surgical performance and patient outcomes, their source, and the mitigation strategies used to reduce their effect. METHODS: A literature search was conducted on 9 April and 6 December 2021 using MEDLINE, Embase, PsycINFO, Scopus, Web of Science, Cochrane Central Register of Controlled Trials, and the Cochrane Database of Systematic Reviews. Included studies investigated how cognitive biases affect surgery and the mitigation strategies used to combat their impact. The National Institutes of Health tools were used to assess study quality. Inductive thematic analysis was used to identify themes of cognitive bias impact on surgical performance. RESULTS: Thirty-nine studies were included, comprising 6514 surgeons and over 200 000 patients. Thirty-one types of cognitive bias were identified, with overconfidence, anchoring, and confirmation bias the most common. Cognitive biases differentially influenced six themes of surgical performance. For example, overconfidence bias associated with inaccurate perceptions of ability, whereas anchoring bias associated with inaccurate risk-benefit estimations and not considering alternative options. Anchoring and confirmation biases associated with actual patient harm, such as never events. No studies investigated cognitive bias source or mitigation strategies. CONCLUSION: Cognitive biases have a negative impact on surgical performance and patient outcomes across all points of surgical care. This review highlights the scarcity of research investigating the sources that give rise to cognitive biases in surgery and the mitigation strategies that target these factors.

Electroencephalography can provide advance warning of technical errors during laparoscopic surgery.

BACKGROUND: Intraoperative adverse events lead to patient injury and death, and are increasing. Early warning systems (EWSs) have been used to detect patient deterioration and save lives. However, few studies have used EWSs to monitor surgical performance and caution about imminent technical errors. Previous (non-surgical) research has investigated neural activity to predict future motor errors using electroencephalography (EEG). The present proof-of-concept cohort study investigates whether EEG could predict technical errors in surgery. METHODS: In a large academic hospital, three surgical fellows performed 12 elective laparoscopic general surgeries. Audiovisual data of the operating room and the surgeon's neural activity were recorded. Technical errors and epochs of good surgical performance were coded into events. Neural activity was observed 40 s prior and 10 s after errors and good events to determine how far in advance errors were detected. A hierarchical regression model was used to account for possible clustering within surgeons. This prospective, proof-of-concept, cohort study was conducted from July to November 2021, with a pilot period from February to March 2020 used to optimize the technique of data capture and included participants who were blinded from study hypotheses. RESULTS: Forty-five technical errors, mainly due to too little force or distance (n = 39), and 27 good surgical events were coded during grasping and dissection. Neural activity representing error monitoring (p = .008) and motor uncertainty (p = .034) was detected 17 s prior to errors, but not prior to good surgical performance. CONCLUSIONS: These results show that distinct neural signatures are predictive of technical error in laparoscopic surgery. If replicated with low false-alarm rates, an EEG-based EWS of technical errors could be used to improve individualized surgical training by flagging imminent unsafe actions-before errors occur and cause patient harm.

Implementation of an Innovative Technology Called the OR Black Box: A Feasibility Study.

Introduction. The operating room (OR) Black Box is an innovative technology that captures and compiles extensive real-time data from the OR, allowing identification and analysis of factors that influence intraoperative procedures and performances - ultimately improving patient safety. Implementation of this kind of technology is still an emerging research area and prone to face challenges. Methods. Observational study running from May 2017 to May 2021 conducted at Copenhagen University Hospital - Rigshospitalet, Denmark, involving 152 OR staff and 306 patients. Feasibility of the OR Black Box was assessed in accordance with Bowen's framework with 8 focus areas. Results. The OR Black Box had a high level of acceptability among stakeholders with 100% participation from management, 93% from OR staff, and 98% from patients. The implementation process improved over time, and an average of 80% of the surgeries conducted were captured. The practical aspects such as numerous formal and informal meetings, ethical and legal approval, recruitment of patients were acceptable, albeit time-consuming. The OR Black Box was adopted without any changes in scheduled surgery program, but capturing hours were adjusted to match the surgery program and relocation of OR staff declining to provide consent was possible. Conclusions. Implementation of the OR Black Box was feasible yet challenging. Management, nearly all staff, and patients embraced the initiative; however, ongoing evaluation, information meetings, and commitment from stakeholders are required and crucial to sustain momentum, continue implementation and expansion. Ideas from this study can be useful in the implementation of similar initiatives.

Analyzing interprofessional teamwork in the operating room: An exploratory observational study using conventional and alternative approaches.

Intraoperative teamwork is vital for patient safety. Conventional tools for studying intraoperative teamwork typically rely on behaviorally anchored rating scales applied at the individual or team level, while others capture narrative information across several units of analysis. This prospective observational study characterizes teamwork using two conventional tools (Operating Theatre Team Non-Technical Skills Assessment Tool [NOTECHS]; Team Emergency Assessment Measure [TEAM]), and one alternative approach (modified-Systems Engineering Initiative for Patient Safety [SEIPS] model). We aimed to explore the advantages and disadvantages of each for providing feedback to improve teamwork practice. Fifty consecutive surgical cases at a Canadian academic hospital were recorded with the OR Black Box®, analyzed by trained raters, and summarized descriptively. Teamwork performance was consistently high within and across cases rated with NOTECHS and TEAMS. For cases analyzed with the modified-SEIPS tool, both optimal and suboptimal teamwork behaviors were identified, and team resilience was frequently observed. NOTECHS and TEAM provided summative assessments and overall pattern descriptions, while SEIPS facilitated a deeper understanding of teamwork processes. As healthcare organizations continue to prioritize teamwork improvement, SEIPS may provide valuable insights regarding teamwork behavior and the broader context influencing performance. This may ultimately enhance the development and effectiveness of multi-level teamwork interventions.

Patient Perceptions of Audio and Video Recording in the Operating Room.

OBJECTIVE: The goal of this study was to determine surgical patients' perceptions of hypothetical continuous audio-video OR recording (ORR). SUMMARY OF BACKGROUND DATA: Continuous audio-video recording of the operating room (OR), akin to the aviation industry's black box, has been proposed as a means to enhance training, supplement the medical record, and allow large-scale analysis of surgical performance and safety. These recordings would include patients' bodies; yet, understanding of patient perceptions regarding such technology is limited. METHODS: Semi-structured interviews were conducted during elective surgery preoperative appointments during a 2-week period in August 2018 at a quaternary care center. Deidentified transcripts were analyzed using thematic analysis. RESULTS: Forty-nine subjects were interviewed. Subjects recognized the potential for recording to improve surgical quality, safety and training. Subjects also desired access to an objective record of their own surgery, for the purposes of future care, medical-legal evidence, and to satisfy their own curiosity and understanding. Subjects had mixed perceptions regarding OR decorum and thus, differing views on the potential effect of ORR on OR behavior; some imagined that ORR would discourage bad behavior and others worried that it would cause unnecessary anxiety to the surgical team. CONCLUSIONS: Patients have a diverse set of views about the potential benefits, risks, and uses for OR data and consider themselves to be important stakeholders. Our study identifies pathways and potential challenges to implementation of continuous audio/video recording in ORs.

The Operating Room Black Box: Understanding Adherence to Surgical Checklists.

OBJECTIVE: We report for the first time the use of the Operating Room Black Box (ORBB) to track checklist compliance, engagement, and quality. BACKGROUND: Implementation of operative checklists is associated with improved outcomes. Compliance is difficult to monitor. Most studies report either no assessment of checklist compliance or deployed in-person short-term assessment. The ORBB a novel artificially intelligence-driven data analytic platform affords the opportunity to assess checklist compliance without disrupting surgical workflow. METHODS: This was a retrospective review of prospectively collected ORBB data. Operative cases included elective surgery at a quaternary referral center. Cases were analyzed as prepolicy change (first 9 months) or as a postpolicy change (last 9 months). Measures of checklist compliance, engagement, and quality were assessed. RESULTS: There were 3879 cases that were performed and monitored for checklist compliance between August 15, 2020, and February 20, 2022. The overall scores for compliance, engagement, and quality were 81%, 84%, and 67% respectively. When broken down by phase, the scores for time-out were compliance 100%, engagement 98%, and quality 61%. Scores for the debrief phase were 81% for compliance, 98% for engagement, and 66% for quality. After a hospital policy change, the debrief scores improved significantly (85%; P <0.001 for compliance, 88%; P <0.001 for engagement and 71%; P <0.001 for quality). CONCLUSIONS: ORBB provides the unprecedented ability to assess not only compliance with surgical safety checklists but also engagement and quality. Utilization of this technology allows the assessment of compliance in near real time and to accurately address safety threats that may arise from noncompliance.

Eye Tracking Use in Surgical Research: A Systematic Review.

INTRODUCTION: Eye tracking (ET) is a popular tool to study what factors affect the visual behaviour of surgical team members. To our knowledge, there have been no reviews to date that evaluate the broad use of ET in surgical research. This review aims to identify and assess the quality of this evidence, to synthesize how ET can be used to inform surgical practice, and to provide recommendations to improve future ET surgical studies. METHODS: In line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, a systematic literature review was conducted. An electronic search was performed in MEDLINE, Cochrane Central, Embase, and Web of Science databases up to September 2020. Included studies used ET to measure the visual behaviour of members of the surgical team during surgery or surgical tasks. The included studies were assessed by two independent reviewers. RESULTS: A total of 7614 studies were identified, and 111 were included for data extraction. Eleven applications were identified; the four most common were skill assessment (41%), visual attention assessment (22%), workload measurement (17%), and skills training (10%). A summary was provided of the various ways ET could be used to inform surgical practice, and three areas were identified for the improvement of future ET studies in surgery. CONCLUSIONS: This review provided a comprehensive summary of the various applications of ET in surgery and how ET could be used to inform surgical practice, including how to use ET to improve surgical education. The information provided in this review can also aid in the design and conduct of future ET surgical studies.

Step, Error, and Event Frameworks in Endovascular Aortic Repair.

OBJECTIVE: Competency-based surgical education requires detailed and actionable feedback to ensure adequate and efficient skill development. Comprehensive operative capture systems such as the Operating Room Black Box (ORBB; Surgical Safety Technologies, Inc), which continuously records and synchronizes multiple sources of intraoperative data, have recently been integrated into hybrid rooms to provide targeted feedback to endovascular teams. The objective of this study is to develop step, error, and event frameworks to evaluate technical performance in elective endovascular aortic repair (EVAR) comprehensively captured by the ORBB (Surgical Safety Technologies, Inc; Toronto, Canada). METHODS: This study is based upon a modified Delphi consensus process to create evaluation frameworks for steps, errors, and events in EVAR. International experts from Vascular Surgery and Interventional Radiology were identified, based on their records of publications and invited presentations, or serving on relevant journal editorial boards. In an initial open-ended survey round, experts were asked to volunteer a comprehensive list of steps, errors, and events for a standard EVAR of an infrarenal aorto-iliac aneurysm (AAA). In subsequent survey rounds, the identified items were presented to the expert panel to rate on a 5-point Likert scale. Delphi survey rounds were repeated until the process reached consensus with a predefined agreement threshold (Cronbach α>0.7). The final frameworks were constructed with items achieving an agreement (responses of 4 or 5) from greater than 70% of experts. RESULTS: Of 98 invited proceduralists, 38 formed the expert consensus panel (39%), consisting of 29 vascular surgeons and 9 interventional radiologists, with 34% from North America and 66% from Europe. Consensus criteria were met following the third round of the Delphi consensus process (Cronbach α=0.82-0.93). There were 15, 32, and 25 items in the error, step, and event frameworks, respectively (within-item agreement=74%-100%). CONCLUSION: A detailed evaluation tool for the procedural steps, errors, and events in infrarenal EVAR was developed. This tool will be validated on recorded procedures in future work: It may focus skill development on common errors and hazardous steps. This tool might be used to provide high-quality feedback on technical performance of trainees and experienced surgeons alike, thus promoting surgical mastery.

Perceptions of safety culture and recording in the operating room: understanding barriers to video data capture.

OBJECTIVE: Recording in the operating room is an important tool to help surgical teams improve their performance. This is becoming more feasible using the Operating Room Black Box, a comprehensive data capture platform. Operating room (OR) staff, however, may voice reasonable concerns as recording initiatives are implemented. The objective of this study was to assess pre-implementation attitudes of OR staff toward operative recording and explore the relationship of these attitudes to the themes of (1) safety culture, (2) impostor syndrome, and (3) privacy concerns. METHODS: This cross-sectional survey study measured staff members' beliefs and opinions of operative recording and used three previously validated tools (safety attitudes questionnaire, clance impostor phenomenon scale, and dispositional privacy concern) to assess personal and professional factors. Concepts were correlated using Pearson's correlation coefficient. RESULTS: Forty-three staff members participated in this study, with a response rate of 45% (n = 43/96, 20/22 nurses, 9/11 gynecologists, 14/63 anesthesiologists). Opinions of operative data capture were generally positive (5-point Likert scale, mean = 3.81, SD = 0.91). Nurses tended to have more favorable opinions of the OR Black Box as compared to gynecologists and anesthesiologists, though this did not reach statistical significance (4.15 vs. 3.67 vs 3.43, p = 0.06). Impostor syndrome characteristics correlated with concerns about litigation related to recording (r = - 0.32, p = 0.04). CONCLUSION: There are personal and professional attributes of the OR team that impact perceptions of the OR Black Box and implications around privacy and litigation. Addressing these concerns may facilitate successful implementation of the OR Black Box and improve team communication and patient safety in the OR.

System Factors Affecting Patient Safety in the OR: An Analysis of Safety Threats and Resiliency.

OBJECTIVE: The objective of this study is to determine the characteristics and frequency of intraoperative safety threats and resilience supports using a human factors measurement tool. BACKGROUND: Human factors analysis can provide insight into how system elements contribute to intraoperative adverse events. Empiric evidence on safety threats and resilience in surgical practice is lacking. METHODS: A cross-sectional study of 24 patients undergoing elective laparoscopic general surgery at a single center in the Netherlands from May to November, 2017 was conducted. Video, audio, and patient physiologic data from all included procedures were obtained through a multichannel synchronized recording device. Trained analysts reviewed the recordings and coded safety threats and resilience supports. The codes were categorized into 1 of 6 categories (person, task, tools and technology, physical environment, organization, and external environment). RESULTS: A median of 14 safety threats [interquartile range (IQR) 11-16] and 12 resilience supports (IQR 11-16) were identified per case. Most safety threat codes (median 9, IQR 7-12) and resilience support codes (median 10, IQR 7-12) were classified in the person category. The organization category contained a median of 2 (IQR 1-2) safety threat codes and 2 (IQR 2-3) resilience support codes per case. The tools and technology category contributed a small number of safety threats (median 1 per case, IQR 0-1), but rarely provided resilience support. CONCLUSIONS: Through a detailed human factors analysis of elective laparoscopic general surgery cases, this study provided a quantitative analysis of the existing safety threats and resilience supports in a modern endoscopic operating room.

Quantifying the "Assistant Effect" in Robotic-Assisted Radical Prostatectomy (RARP): Measures of Technical Performance.

PURPOSE: Surgeons are reliant on the bedside assistant during robotic surgeries. Using a modified global rating scale (GRS), we aim to assess the association between an assistant's technical skill on surgeon performance in Robotic-Assisted Radical Prostatectomy (RARP). METHODS: Prospective, intraoperative video from RARP cases at three centers were collected. Baseline demographic and RARP-experience data were collected from participating surgeons and trainees. The dissection of the prostatic pedicle and neurovascular bundle step (NVB) was analyzed. Expert analysts scored the console surgeon performance using the Global Evaluative Assessment of Robotic Skills (GEARS), and the bedside assistant performance using a modified Objective Structured Assessment of Technical Skills (aOSATS). The primary outcome is the association between console surgeon performance, as measured by GEARS, and assistant skill, as measured by aOSATS. Spearman's rho correlations were used to test the relationship between assistant and surgeon technical performance, and a multivariable linear regression model was created to test this association while controlling for patient factors. RESULTS: 92 RARP cases were available for the analysis, comprising 14 console surgeons and 22 different bedside assistants. In only 5 (5.4%) cases, the neurovascular bundle step was completed by a trainee, and in 13 (14.1%) of cases, a staff-level surgeon acted as the bedside assistant. aOSATS score was significantly associated with robotic console experience (P = 0.011), and prior laparoscopic experience (P < 0.001). Assistant aOSATS score showed a weak but significant correlation with surgeon GEARS score during the neurovascular bundle step (spearman's rho = 0.248, P = 0.028). On linear regression, aOSATS remained a significant predictor of console surgeon performance (P = 0.016), after controlling for patient age and BMI, prostate volume, tumor stage, and presence of nerve-sparing. CONCLUSIONS: This is the first study to assess the association between assistant technical skill and surgeon performance in RARP. Additionally, we have provided validity evidence for a modified OSATS global rating scale for training and assessing bedside assistant performance.

Development of a Model for Video-Assisted Postoperative Team Debriefing.

BACKGROUND: Video-assisted debriefing may be a powerful tool to improve surgical team performance. Nevertheless, a true operating team debriefing culture is lacking to date. This study aimed to find evidence on how to debrief the surgical team and develop a model suitable for debriefing using a video and medical data recorder (MDR) in the operating room (OR). METHODS: A review of the PubMed and Embase databases and Cochrane Library was performed. The identified literature was studied and combined with a conceptual framework to develop a model for postoperative video-assisted team debriefing. Thirty-five surgical cases were recorded with an MDR and debriefed with the operating team using the proposed debrief model and a standardized video-assisted performance report. A questionnaire was used to assess the participants' satisfaction with this debrief model. RESULTS: Debrief models and methods are extensively described in the current medical literature. An overview was provided. The OR team needs a structured debrief model, minimizing resource, effort, and motivational constraints. A structured six-step team debrief model suitable for video-assisted OR team debriefing was developed. The model was tested in 35 multidisciplinary MDR-assisted debriefing sessions and the debriefing sessions were overall rated with a mean of 7.8 (standard deviation 1.4, 10-point Likert scale) by participants. CONCLUSIONS: Debriefing surgical teams using a video and MDR in the OR requires a model on how to use such recordings optimally. To date, no such model existed. The proposed debrief model was tested using a multisource MDR and may be used to facilitate OR debriefing across various settings.

Six Sigma in surgery: how to create a safer culture in the operating theatre using innovative technology.

Safe delivery of patient care in the operating theatre is complex and co-dependent of many individual, organisational, and environmental factors, including patient, task and technology, individual, and human factors. The Six Sigma approach aims to implement a data-driven strategy to reduce variability and consequently improve safety. Analytical data platforms such as a Black Box ought to be embraced to support process optimisation and ultimately create a higher level of Six Sigma safety performance of the operating theatre team.

Non-technical skills and device-related interruptions in minimally invasive surgery.

BACKGROUND: Device-related interruptions in the operating room (OR) may create stress among health care providers and delays. Although non-technical skills (NTS) of the OR teams, such as situational awareness and communication, are expected to influence device-related interruptions, empirical data on this relationship are limited. METHODS: We performed a prospective cohort study of 144 consecutive elective laparoscopic operations during 13 months. A data capture system called the OR Black Box® was used to characterize device-related interruptions, NTS, and distractions. Device-related interruptions were classified according to a priori established categories. Positive and negative NTS instances were identified according to validated measurement tools specific for nurses and surgeons. We assessed the relationship between NTS and device-related interruptions after adjusting for potential confounders. RESULTS: A total of 86 device-related interruptions occurred in 48 of 144 operations (33%). They were most frequently classified as device failure (54%) followed by improper assembly (19%) and disconnection (14%). Medians of 1 [interquartile range (IQR) 0-3] and 1 (IQR 0-2) negative NTS instance per operation were demonstrated by nurses and surgeons, respectively. Medians of 28 (IQR 15-38) and 40 (IQR 28-118) positive NTS instances per operation were demonstrated by nurses and surgeons. In a multivariable analysis, a higher frequency of negative NTS instances demonstrated by nurses was associated with device-related interruptions after risk adjustment (Odds Ratio 1.33, p = 0.02). CONCLUSIONS: In elective laparoscopic operations, an increased likelihood of device-related interruptions in the OR was associated with more frequent negative NTS demonstrations by nursing teams.

The effect of intraoperative distractions on severe technical events in laparoscopic bariatric surgery.

BACKGROUND: Given the complexity of the operating room (OR), it is unsurprising that surgeons frequently feel distracted while performing operative tasks. However, this relationship is not well studied in live surgeries. The objective of this study is to investigate the relationship between intraoperative distractions and technical events using surgical data. METHODS: Roux-en-Y gastric bypass operation data from three tertiary care hospitals in Toronto, Canada were collected prospectively between 2017 and 2019 by a comprehensive operative capture platform (OR Black Box) and analyzed retrospectively. Time-synchronized audiovisual recordings of the OR and laparoscopic videos of the operation were collected, along with clinical data from the electronic health record. Video data was labeled for technical data, non-technical data, and distractions by trained coders. Procedural steps were categorized based on criticality. The relationship between severe technical events (case having 0 or 1 events vs. 2 or more) and the rate of distractions (machine alarms, external communications, people entering/exiting) in critical procedural steps was assessed through logistic regression, adjusting for team factors (surgeons' technical skills, nurse changeovers). RESULTS: 60 Roux-en-Y cases were analyzed. Average case duration was 83.2 min (SD = 21.97). Distractions occurred 47.6 times/h (SD = 20.3), with most frequent distraction being machine alarms (4.45/10 min, SD = 2.88). For unadjusted analysis, alarms (OR = 1.29, 95% CI 1.05-1.66) and surgeon's technical skills (OR = 0.65, 95% CI 0.43-0.93) were found to be correlated with severe technical events. After adjusting for team factors, alarms were found to be positively related with the presence of severe technical events (OR = 1.58, 95% CI 1.18-2.33) during high-criticality procedural steps. CONCLUSIONS: This study showed a significant association between intraoperative distractions, in particular machine alarms, and severe technical events during high-criticality procedural steps. Further investigation will assess the temporal relationship between distractions and technical events and assess mitigation strategies to create a safer surgical environment.

Implementation of the Operating Room Black Box Research Program at the Ottawa Hospital Through Patient, Clinical, and Organizational Engagement: Case Study.

BACKGROUND: A large proportion of surgical patient harm is preventable; yet, our ability to systematically learn from these incidents and improve clinical practice remains limited. The Operating Room Black Box was developed to address the need for comprehensive assessments of clinical performance in the operating room. It captures synchronized audio, video, patient, and environmental clinical data in real time, which are subsequently analyzed by a combination of expert raters and software-based algorithms. Despite its significant potential to facilitate research and practice improvement, there are many potential implementation challenges at the institutional, clinician, and patient level. This paper summarizes our approach to implementation of the Operating Room Black Box at a large academic Canadian center. OBJECTIVE: We aimed to contribute to the development of evidence-based best practices for implementing innovative technology in the operating room for direct observation of the clinical performance by using the case of the Operating Room Black Box. Specifically, we outline the systematic approach to the Operating Room Black Box implementation undertaken at our center. METHODS: Our implementation approach included seeking support from hospital leadership; building frontline support and a team of champions among patients, nurses, anesthesiologists, and surgeons; accounting for stakeholder perceptions using theory-informed qualitative interviews; engaging patients; and documenting the implementation process, including barriers and facilitators, using the consolidated framework for implementation research. RESULTS: During the 12-month implementation period, we conducted 23 stakeholder engagement activities with over 200 participants. We recruited 10 clinician champions representing nursing, anesthesia, and surgery. We formally interviewed 15 patients and 17 perioperative clinicians and identified key themes to include in an information campaign run as part of the implementation process. Two patient partners were engaged and advised on communications as well as grant and protocol development. Many anticipated and unanticipated challenges were encountered at all levels. Implementation was ultimately successful, with the Operating Room Black Box installed in August 2018, and data collection beginning shortly thereafter. CONCLUSIONS: This paper represents the first step toward evidence-guided implementation of technologies for direct observation of performance for research and quality improvement in surgery. With technology increasingly being used in health care settings, the health care community should aim to optimize implementation processes in the best interest of health care professionals and patients.

First-year Analysis of the Operating Room Black Box Study.

OBJECTIVE: To characterize intraoperative errors, events, and distractions, and measure technical skills of surgeons in minimally invasive surgery practice. BACKGROUND: Adverse events in the operating room (OR) are common contributors of morbidity and mortality in surgical patients. Adverse events often occur due to deviations in performance and environmental factors. Although comprehensive intraoperative data analysis and transparent disclosure have been advocated to better understand how to improve surgical safety, they have rarely been done. METHODS: We conducted a prospective cohort study in 132 consecutive patients undergoing elective laparoscopic general surgery at an academic hospital during the first year after the definite implementation of a multiport data capture system called the OR Black Box to identify intraoperative errors, events, and distractions. Expert analysts characterized intraoperative distractions, errors, and events, and measured trainee involvement as main operator. Technical skills were compared, crude and risk-adjusted, among the attending surgeon and trainees. RESULTS: Auditory distractions occurred a median of 138 times per case [interquartile range (IQR) 96-190]. At least 1 cognitive distraction appeared in 84 cases (64%). Medians of 20 errors (IQR 14-36) and 8 events (IQR 4-12) were identified per case. Both errors and events occurred often in dissection and reconstruction phases of operation. Technical skills of residents were lower than those of the attending surgeon (P = 0.015). CONCLUSIONS: During elective laparoscopic operations, frequent intraoperative errors and events, variation in surgeons' technical skills, and a high amount of environmental distractions were identified using the OR Black Box.

System Factors Affecting Intraoperative Risk and Resilience: Applying a Novel Integrated Approach to Study Surgical Performance and Patient Safety.

OBJECTIVE: To identify and categorize system factors in complex laparoscopic surgery that have the potential to either threaten patient safety or support system resilience. BACKGROUND: The operating room is a uniquely complex sociotechnical work system wherein surgical successes prevail despite pervasive safety threats. Holistically characterizing intraoperative factors that thus support system resilience in addition to those that threaten patient safety using contextual methodologies is critical for optimizing surgical safety overall. METHOD: In this prospective descriptive interdisciplinary study, 19 audio/video recordings of complex laparoscopic general surgical procedures were directly observed and transcribed. Using a qualitative systems-based approach, intraoperative human factors with the potential to impact patient safety, either as a safety threat or as a support for resilience, were identified. Adverse events were further assessed for shared threats and supports. Data collection was guided by the Systems Engineering Initiative for Patient Safety 2.0 work system model. RESULTS: A total of 1083 relevant observations were made over 39.8 hours of operative time, enabling the identification of 79 distinct safety threats and 67 resilience supports within the surgical system. Safety threats associated with the physical environment, tasks, organization, and equipment were prevalent and observed in equal measure, whereas supports for resilience were predominantly attributed to clinician behaviors, including proactive team management and skills coaching. Two subclinical adverse events were identified; shared safety threats included suboptimal technology design, whereas shared resilience supports included calm clinician behavior and redundant intraoperative resourcing. CONCLUSIONS: Safety threats and resilience supports were found to be systematic in the surgical setting. Identified safety threats should be prioritized for remediation, and clinician behaviors that contribute to fostering resilience should be valued and protected.