Development and Testing of Step, Error, and Event Frameworks to Evaluate Technical Performance in Peripheral Endovascular Interventions.

OBJECTIVE: Tools for endovascular performance assessment are necessary in competency based education. This study aimed to develop and test a detailed analysis tool to assess steps, errors, and events in peripheral endovascular interventions (PVI). METHODS: A modified Delphi consensus was used to identify steps, errors, and events in iliac-femoral-popliteal endovascular interventions. International experts in vascular surgery, interventional radiology, cardiology, and angiology were identified, based on their scientific track record. In an initial open ended survey round, experts volunteered a comprehensive list of steps, errors, and events. The items were then rated on a five point Likert scale until consensus was reached with a pre-defined threshold (Cronbach's alpha > 0.7) and > 70% expert agreement. An experienced endovascular surgeon applied the finalised frameworks on 10 previously videorecorded elective PVI cases. RESULTS: The expert consensus panel was formed by 28 of 98 invited proceduralists, consisting of three angiologists, seven interventional radiologists, five cardiologists, and 13 vascular surgeons, with 29% from North America and 71% from Europe. The Delphi process was completed after three rounds (Cronbach's alpha; αsteps = 0.79; αerrors = 0.90; αevents = 0.90), with 15, 26, and 18 items included in the final step (73 - 100% agreement), error (73 - 100% agreement), and event (73 - 100% agreement) frameworks, respectively. The median rating time per case was 4.3 hours (interquartile range [IQR] 3.2, 5 hours). A median of 55 steps (IQR 40, 67), 27 errors (IQR 21, 49), and two events (IQR 1, 6) were identified per case. CONCLUSION: An evaluation tool for the procedural steps, errors, and events in iliac-femoral-popliteal endovascular procedures was developed through a modified Delphi consensus and applied to recorded intra-operative data to identify hazardous steps, common errors, and events. Procedural mastery may be promoted by using the frameworks to provide endovascular proceduralists with detailed technical performance feedback.

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.

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.

Implementing new surgical technology: a national perspective on case volume requirement for proficiency in transanal total mesorectal excision

Background: Early data suggest that transanal total mesorectal excision (TaTME) is a safe alternative to the abdominal approach for rectal cancer. This study aims to understand the approach to the management of rectal cancer in Canada and to ascertain perspectives on introducing TaTME. Methods: Surgeons were invited to complete a survey that asked about their management practices relating to rectal cancer and their opinions regarding TaTME. Results: Ninety-four surgeons completed the survey (38% response rate). The number of rectal cancer cases handled annually by surgeons varied widely (1­80 cases, median 15 cases). Twenty-seven percent of respondents performed TaTME at the time of the survey, and 43% of those who did not said they planned on learning the technique. Surgeons who performed TaTME felt that a higher annual volume of rectal cancer cases was required to maintain proficiency than did non-TaTME surgeons (median 20 cases [interquartile range (IQR) 15­25 cases] v. 15 cases [IQR 10­20 cases]). Surgeons who performed TaTME also felt that a higher annual volume of TaTME cases was required to maintain proficiency (median 12 cases [IQR 10­19 cases] v. 9 cases [IQR 5­10 cases]). Conclusion: These findings help define the current practice environment for rectal cancer surgeons in Canada and highlight the complex issues associated with learning TaTME.

Contexte: Selon des données préliminaires, l'exérèse totale du mésorectum par voie transanale (ou TaTME, pour transanal total mesorectal excision) est une solution de rechange sécuritaire à l'approche abdominale pour le cancer du rectum. Cette étude vise à faire le point sur le traitement du cancer rectal au Canada et à mesurer l'intérêt à l'endroit de la technique TaTME. Méthodes: Des chirurgiens ont été invités à répondre à un sondage sur leur façon de prendre en charge le cancer rectal et sur leur opinion au sujet de la TaTME. Résultats: Quatre-vingt-quatorze chirurgiens ont répondu au sondage (taux deréponse 38 %). Le nombre de cancer rectaux traités annuellement par chirurgien variait grandement (de 1 à 80 cas, nombre médian 15 cas). Vingt-sept pour cent des participants appliquaient la TaTME au moment du sondage et 43 % de ceux qui ne l'appliquaient pas disait avoir l'intention de s'y initier. Les chirurgiens qui appliquaient la TaTME se disaient d'avis qu'il fallait un volume annuel plus élevé de cas de cancer rectal pour garder la main comparativement aux chirurgiens qui n'appliquaient pas cette technique (nombre médian de 20 cas [éventail interquartile (ÉIQ) 15­25 cas] c. 15 cas [ÉIQ 10­20 cas]). Les chirurgiens qui appliquaient la TaTME ont aussi estimé qu'il fallait un volume annuel plus élevé de cas de TaTME pour garder la main (nombre médian de 12 cas [ÉIQ 10­19 cas] c. 9 cases (ÉIQ 5­10 cas]). Conclusion: Ces observations permettent de mieux définir les pratiques actuelles des chirurgiens qui soignent le cancer rectal au Canada et mettent en lumière les enjeux complexes inhérents à l'apprentissage de la TaTME.

A framework to build capacity for a reflex-testing program for Lynch syndrome.

PURPOSE: Lynch syndrome (LS) is the most common inherited cause of colorectal cancer. Although testing all colorectal tumors for LS is recommended, the uptake of reflex-testing programs within health systems has been limited. This multipronged study describes the design of a provincial program for reflex testing in Ontario, Canada. METHODS: We recruited key stakeholders to participate in qualitative interviews to explore the barriers and facilitators to the implementation of a reflex-testing program. Data were analyzed in an iterative manner, key themes identified, and a framework for a proposed program developed. RESULTS: Twenty-six key informants participated in our interviews, and several themes were identified. These included providing education for stakeholders (patients, primary care providers, surgeons); challenges with sustaining various resources (laboratory costs, increased workload for pathologists); ensuring consistency of reporting test results; and developing a plan to measure program success. Using these themes, a framework for the reflex-testing program was developed. At a subsequent stakeholder meeting, the framework was refined, and recommendations were identified. CONCLUSIONS: This study identifies factors to ensure the effective implementation of a population-level program for reflex LS testing. The final product is a prototype that can be utilized in other jurisdictions, taking into account local environmental considerations.

Learning by Example: An International Perspective on Reflex-Testing for Lynch Syndrome.

BACKGROUND: Lynch syndrome (LS), an autosomal dominant cancer syndrome, is the most common cause of hereditary colon cancer. Currently, however, less than 5% of patients with LS have been identified. Reflex-testing programs (in which tumors of patients with colorectal cancer are routinely evaluated for LS) have been proposed for better identification of affected individuals, yet the uptake of these programs within health care systems is limited. This study explored the structure, implementation challenges, and future directions of existing international population-based reflex LS testing programs. METHODS: The study identified existing reflex-testing LS programs through the current literature and through a qualitative sampling approach. Key informants from each program were interviewed. Qualitative data were analyzed using a grounded theory analytic technique approach. RESULTS: The interviews were completed by 26 informants across seven identified programs. Three key themes were identified: (1) tension between a program imposed on stakeholders (a top-down approach) versus initiation of the program at the stakeholder level (bottom-up approach), (2) identification of pathologists as drivers of program success, and (3) strategies to optimize possible LS patients liaising with genetic counselors. Barriers to successful implementation included lack of stakeholder engagement and concerns regarding cost. Facilitators included strong administration to coordinate patient tracking and flexibility during the implementation process. CONCLUSIONS: Existing reflex-testing LS programs have varying structures, standards, and protocols. Program design can have a direct effect on the uptake of genetic testing. These are important considerations in the large-scale planning of LS reflex-testing programs within health systems.

Laparoscopic translevator approach to abdominoperineal resection for rectal adenocarcinoma: feasibility and short-term oncologic outcomes.

BACKGROUND: The extra-levator approach to abdominal perineal resection (APR) was developed in order to reduce the rates of positive circumferential resection margin. This approach, however, is associated with significant morbidity. We postulate that a less radical resection of the levators done laparoscopically could significantly decrease the rate of perineal complications while ensuring an oncologically adequate specimen. To date, to our knowledge, there are no reports in the literature describing a laparoscopic translevator approach for APR. The purpose of this study is to describe our initial experience with this approach and assess our short-term oncologic and clinical outcomes. METHODS: This is a retrospective study of patients who underwent laparoscopic APR with intra-abdominal levator transection for rectal cancer from 2012 to 2014 at a single tertiary care institution. Main outcome measures include: perineal flap rates, post-operative complications, length of stay, distance from tumour to circumferential resection margin, R0 status, and disease recurrence. Data are presented as median (interquartile range) unless otherwise noted. RESULTS: Seventeen cases were identified. Patient age was 61 (range 34-75), and 59 % were male. Pre-operative distance of the tumour from the anal verge was 2.6 cm (0.4-3.9). Post-operative length of stay was 4 (4-6) days. One patient required a perineal flap for reconstruction. Four patients (22 %) had perineal complications (three wound infections and one hernia). No patients reported sexual dysfunction, and one (5 %) developed urinary retention. Five (29 %) patients had a complete pathological response. The circumferential resection margin was 1.5 (0.8-2.5) cm, with no positive margins reported. The number of retrieved lymph nodes was 12 (range 2-30). Follow-up was 9.7 months (range 20 days-23 months), during which one patient developed recurrent disease. CONCLUSIONS: This study describes a novel surgical approach to APR that has the potential to both decrease perineal complications and provide excellent oncologic results.

Individualized deliberate practice on a virtual reality simulator improves technical performance of surgical novices in the operating room: a randomized controlled trial.

OBJECTIVE: The purpose of this study was to investigate whether individualized deliberate practice on a virtual reality (VR) simulator results in improved technical performance in the operating room. BACKGROUND: Training on VR simulators has been shown to improve technical performance in the operating room (OR). Currently described VR curricula consist of trainees practicing the same tasks until expert proficiency is reached. It has yet to be investigated whether the individualized deliberate practice, where curricula tasks vary depending on prior levels of technical proficiency, would translate into the OR. METHODS: This single-blinded prospective trial randomized 16 novice surgical residents to a deliberate practice (DP) group and a conventional residency training group. Both groups performed a laparoscopic cholecystectomy in the OR that was video-recorded. Technical performance of DP group residents in the OR was assessed using 3 validated assessment tools. A score of less than 60% on any component of the assessment tool resulted in the trainee practicing a specific task on the VR simulator. The DP group practiced on the simulator as per their individualized schedule. Both groups then performed another laparoscopic cholecystectomy. A blinded expert assessed the OR recordings using a validated global rating scale. RESULTS: Although both groups had similar technical abilities preintervention [DP: median score, 13.5 (9.3-15.0); control: median score, 14.5 (9.3-17.8); P = 0.45], the DP residents had a superior technical performance postintervention [DP: median score, 17.0 (15.3-18.5); control: median score, 12.5 (7.5-14.0); P = 0.03]. Of 8 DP residents, 6 practiced 5 basic VR tasks (median 1 trial to pass), and 7 of 8 practiced 2 advanced tasks (median 4 trials to pass). CONCLUSIONS: A curriculum of deliberate individualized practice on a VR simulator improves technical performance in the OR. This has implications to greatly improve the feasibility of implementing simulation-based curricula in residency training programs, rather then having them being limited to research protocols.

Remote Assessment of Real-World Surgical Safety Checklist Performance Using the OR Black Box: A Multi-Institutional Evaluation.

BACKGROUND: Large-scale evaluation of surgical safety checklist performance has been limited by the need for direct observation. The operating room (OR) Black Box is a multichannel surgical data capture platform that may allow for the holistic evaluation of checklist performance at scale. STUDY DESIGN: In this retrospective cohort study, data from 7 North American academic medical centers using the OR Black Box were collected between August 2020 and January 2022. All cases captured during this period were analyzed. Measures of checklist compliance, team engagement, and quality of checklist content review were investigated. RESULTS: Data from 7,243 surgical procedures were evaluated. A time-out was performed during most surgical procedures (98.4%, n = 7,127), whereas a debrief was performed during 62.3% (n = 4,510) of procedures. The mean percentage of OR staff who paused and participated during the time-out and debrief was 75.5% (SD 25.1%) and 54.6% (SD 36.4%), respectively. A team introduction (performed 42.6% of the time) was associated with more prompts completed (31.3% vs 18.7%, p < 0.001), a higher engagement score (0.90 vs 0.86, p < 0.001), and a higher percentage of team members who ceased other activities (80.3% vs 72%, p < 0.001) during the time-out. CONCLUSIONS: Remote assessment using OR Black Box data provides useful insight into surgical safety checklist performance. Many items included in the time-out and debrief were not routinely discussed. Completion of a team introduction was associated with improved time-out performance. There is potential to use OR Black Box metrics to improve intraoperative process measures.

Validation of a structured training and assessment curriculum for technical skill acquisition in minimally invasive surgery: a randomized controlled trial.

OBJECTIVE: : To develop and validate an ex vivo comprehensive curriculum for a basic laparoscopic procedure. BACKGROUND: : Although simulators have been well validated as tools to teach technical skills, their integration into comprehensive curricula is lacking. Moreover, neither the effect of ex vivo training on learning curves in the operating room (OR), nor the effect on nontechnical proficiency has been investigated. METHODS: : This randomized single-blinded prospective trial allocated 20 surgical trainees to a structured training and assessment curriculum (STAC) group or conventional residency training. The STAC consisted of case-based learning, proficiency-based virtual reality training, laparoscopic box training, and OR participation. After completion of the intervention, all participants performed 5 sequential laparoscopic cholecystectomies in the OR. The primary outcome measure was the difference in technical performance between the 2 groups during the first laparoscopic cholecystectomy. Secondary outcome measures included differences with respect to learning curves in the OR, technical proficiency of each sequential laparoscopic cholecystectomy, and nontechnical skills. RESULTS: : Residents in the STAC group outperformed residents in the conventional group in the first (P = 0.004), second (P = 0.036), third (P = 0.021), and fourth (P = 0.023) laparoscopic cholecystectomies. The conventional group demonstrated a significant learning curve in the OR (P = 0.015) in contrast to the STAC group (P = 0.032). Residents in the STAC group also had significantly higher nontechnical skills (P = 0.027). CONCLUSIONS: : Participating in the STAC shifted the learning curve for a basic laparoscopic procedure from the operating room into the simulation laboratory. STAC-trained residents had superior technical proficiency in the OR and nontechnical skills compared with conventionally trained residents. (The study registration ID is NCT01560494.).

Development and validation of a comprehensive curriculum to teach an advanced minimally invasive procedure: a randomized controlled trial.

OBJECTIVE: To develop and validate a comprehensive ex vivo training curriculum for laparoscopic colorectal surgery. BACKGROUND: Simulators have been shown to be viable systems for teaching technical skills outside the operating room; however, integration of simulation training into comprehensive curricula remains a major challenge in modern surgical education. Currently, no curricula have been described or validated for advanced laparoscopic procedures. METHODS: This prospective, single-blinded randomized controlled trial allocated 25 surgical residents to receive either conventional residency training or a comprehensive training curriculum for laparoscopic colorectal surgery. The curriculum consisted of proficiency-based psychomotor training on a virtual reality simulator, cognitive training, and participation in a cadaver lab. The primary outcome measure in this study was surgical performance in the operating room. All participants performed a laparoscopic right colectomy, which was video recorded and assessed using 2 previously validated assessment tools. Secondary outcome measures were knowledge relating to the execution of the procedure, assessed with a multiple-choice test, and technical performance on the simulator. RESULTS: Curricular-trained residents demonstrated superior performance in the operating room compared with conventionally trained residents (global score 16.0 [14.5-18.0] versus 8.0 [6.0-14.5], P = 0.030; number of operative steps performed 16.0 [12.5-17.5] versus 8.0 [6.0-14.5], P = 0.021; procedure-specific score 71.1 [54.4-81.6] versus 51.1 [36.7-74.4], P = 0.122). Curricular-trained residents scored higher on the multiple-choice test (10 [9-11] versus 7.5 [5.3-7.5], P = 0.047), and outperformed conventionally trained residents in 7 of 8 tasks on the simulator. CONCLUSIONS: Participation in a comprehensive ex vivo training curriculum for laparoscopic colorectal surgery results in improved technical knowledge and improved performance in the operating room compared with conventional residency training. Reg. ID#NCT 01371136.

A comparison of 2 ex vivo training curricula for advanced laparoscopic skills: a randomized controlled trial.

OBJECTIVE: To compare the effectiveness and cost of 2 ex vivo training curricula for laparoscopic suturing. BACKGROUND: Although simulators have been developed to teach laparoscopic suturing, a barrier to their wide implementation in training programs is a lack of knowledge regarding their relative training benefit and their associated cost. METHOD: This prospective single-blinded randomized trial allocated 24 surgical residents to train to proficiency using either a virtual reality (VR) simulator or box trainer. All residents then placed intracorporeal laparoscopic stitches during a Nissen fundoplication on a patient. The operating room (OR) cases were video-recorded and technical proficiency was assessed using 2 validated tools. OR performance of both groups was compared to that of conventionally trained residents and to fellowship-trained surgeons. A cost analysis of box training, VR training, and conventional residency training across Canadian surgical programs was performed. RESULTS: After ex vivo training, no significant differences in laparoscopic suturing in the OR were found between the 2 groups with respect to time (P = 0.74)-global rating score (P = 0.65) or checklist score (P = 0.97). It took conventionally trained residents 6 practice attempts in the OR to achieve the technical proficiency of the ex vivo trained groups (P = 0.83). VR training was more efficient than box training (transfer effectiveness ratio of 2.31 vs 1.13). The annual cost of training 5 residents on the FLS trainer box was $11,975.00, on the VR simulator was $77,500.00, and conventional residency training was $17,380.00. Over 5 years, box training was the most cost-effective option for all programs, and VR training was more cost-effective for programs with more 10 residents. CONCLUSIONS: Training on either a VR simulator or on a box trainer significantly decreased the learning curve necessary to learn laparoscopic suturing. VR training, however, is the more efficient training modality, whereas box training the more cost-effective option.

A prospective study demonstrating the reliability and validity of two procedure-specific evaluation tools to assess operative competence in laparoscopic colorectal surgery.

BACKGROUND: Laparoscopic colorectal surgery is considered an advanced minimally invasive procedure with a long, variable learning curve. Developing an evaluation tool is essential to ensure that individuals reach a certain level of competence prior to performing this procedure independently. To achieve standardization and wide implementation, an assessment tool must be reflective of practice across many institutions. STUDY DESIGN: The purpose of this study is to validate two procedure-specific evaluation tools for laparoscopic colorectal surgery that were developed using innovative consensus methodology. Two procedure-specific rating scales for laparoscopic right and sigmoid colectomy were created using the Delphi method. Nine novice and nine expert laparoscopic sigmoid colectomy videos were prospectively collected, and nine novice and ten expert laparoscopic right colectomy videos were recorded. The experts rated the videos using the procedure-specific technical skills evaluation tool for either laparoscopic right colectomy or laparoscopic sigmoid colectomy. RESULTS: There were statistically significant differences between the expert and novice scores on the laparoscopic right colectomy evaluation tool: the median score of novices was 63.8% and the expert score was 73.1% (p = 0.02). Similarly, there was a significant difference between the median novice score on the sigmoid tool (58.6%) compared with the median expert score (70.7%) (p = 0.003). Cronbach's alpha was 0.82 for the right colectomy evaluation tool and 0.79 for the sigmoid rating scale. CONCLUSIONS: The procedure-specific evaluation tools for laparoscopic right and sigmoid colectomy demonstrate strong reliability and construct validity, and have the potential to be used for technical skills assessment and feedback.

Effect of the surgical safety checklist on provider and patient outcomes: a systematic review.

BACKGROUND: Despite being implemented for over a decade, literature describing how the surgical safety checklist (SSC) is completed by operating room (OR) teams and how this relates to its effectiveness is scarce. This systematic review aimed to: (1) quantify how many studies reported SSC completion versus described how the SSC was completed; (2) evaluate the impact of the SSC on provider outcomes (Communication, case Understanding, Safety Culture, CUSC), patient outcomes (complications, mortality rates) and moderators of these relationships. METHODS: A systematic literature search was conducted using Medline, CINAHL, Embase, PsycINFO, PubMed, Scopus and Web of Science on 10 January 2020. We included providers who treat human patients and completed any type of SSC in any OR or simulation centre. Statistical directional findings were extracted for provider and patient outcomes and key factors (eg, attentiveness) were used to determine moderating effects. RESULTS: 300 studies were included in the analysis comprising over 7 302 674 operations and 2 480 748 providers and patients. Thirty-eight per cent of studies provided at least some description of how the SSC was completed. Of the studies that described SSC completion, a clearer positive relationship was observed concerning the SSC's influence on provider outcomes (CUSC) compared with patient outcomes (complications and mortality), as well as related moderators. CONCLUSION: There is a scarcity of research that examines how the SSC is completed and how this influences safety outcomes. Examining how a checklist is completed is critical for understanding why the checklist is successful in some instances and not others.

Creating a Practical Transformational Change Management Model for Novel Artificial Intelligence-Enabled Technology Implementation in the Operating Room.

Objective: To identify change management (CM) strategies for implementing novel artificial intelligence and similar novel technologies in operating rooms and create a new CM model for future trials and applications inspired by the abovementioned strategies and established models. Methods: Key phases of technology implementation were defined, and strategies for transformational CM were created and applied in a recent CM experience at our institution between October 15, 2020 and October 15, 2021. We appraised existing CM models and propose the newly created model. Results: The key phases of the technology implementation were as follows: (1) team assembly; (2) committee approvals; (3) CM; and (4) system installation and go-live. Key strategies were (1) assemble team with necessary expertise; (2) anticipate potential institutional cultural and regulatory hurdles; (3) add agility to project planning and execution; (4) accommodate institutional culture and regulations; (5) early clinical partner buy-in and stakeholder engagement; and (6) consistent communication, all of which contributed to the new CM model creation. Conclusion: Key CM strategies and a new CM model addressing the unique needs and characteristics of operating room novel technology implementation were identified and created. The new model may be customized and tested for individual institution and project's needs and characteristics.

Ex vivo technical skills training transfers to the operating room and enhances cognitive learning: a randomized controlled trial.

BACKGROUND: Surgical training in the operating room includes acquiring technical skills and cognitive knowledge. Technical skills training on simulated models has been shown to improve technical performance in the operating room, and may also enhance the acquisition of other skills by freeing cognitive capacity. This has yet to be investigated. METHODS: We conducted a single-blinded randomized controlled trial to assess the effect of ex vivo technical skills training on cognitive learning in the operating room. Eighteen novice surgical residents were randomized to 2 groups. All participants were taught the basics of fascial closure and performed 1 closure on a low fidelity synthetic model. Residents in the intervention group practiced on the models until technical proficiency was reached. Residents in the control group had no further contact with the models. All residents then performed a fascial closure on a patient in the operating room while listening to a script that contained relevant clinical information. A validated evaluation tool was used to assess the technical merit of the closure. Finally, all participants completed a multiple-choice test designed to test the information retained from the script. RESULTS: The technical performance of the ex vivo trained group was significantly higher than that of the untrained group (P = 0.04). The ex vivo trained group also performed significantly better on the cognitive retention test (P = 0.03). CONCLUSIONS: Technical skills training using a low fidelity synthetic simulator resulted in improved technical performance in the operating room, and enhanced the ability of residents to attend to cognitive components of surgical expertise.

Evaluating quality and completeness of gastrectomy for gastric cancer: review of surgical videos from the public domain.

BACKGROUND: YouTube® has provided a forum to share surgical videos in the public domain which may be used for education. The quality of surgery and accompanying educational material is unknown. YouTube® videos of gastrectomy with D2 lymphadenectomy (D2-LND) for gastric cancer were evaluated for quality and completeness. METHODS: YouTube® was searched using the terms "D2 lymphadenectomy" and "Gastric Cancer" for open and laparoscopic videos. The Korean Laparoscopic Gastrointestinal Surgical Society (KLASS) outlined 22 steps that define quality and completeness of D2-LND. These guidelines were used to score D2-LND for each video. Four physician reviewers independently scored each surgical video. Scores were compared using Student's t-test. RESULTS: Ten laparoscopic and 10 open surgery videos were assessed. Each video was scored for quality and completeness and assigned a score out of 22. Mean score for open D2-LND was 15 (95% CI: 12.54-17.46). Mean score for laparoscopic D2-LND was 15.4 (95% CI: 14.34-16.46; P=0.77). The most consistently performed steps were the dissection of lymph node stations 1, 3, 4 and 5. The most commonly omitted steps were the dissection of lymph node station 6: exposure and identification of the lowest anterior superior pancreaticoduodenal vein; removal of the prepancreatic soft tissues above the lowest anterior superior pancreaticoduodenal vein; removal of the prepancreatic soft tissues above the level of the bifurcation of the anterior superior pancreaticoduodenal vein and right gastroepiploic vein. CONCLUSIONS: There is a wide range of quality and completeness of D2-LND videos. On average, D2-LND videos are only two-thirds complete.

Utilizing the Operating Room Black Box to Characterize Intraoperative Delays, Distractions, and Threats in the Gynecology Operating Room: A Pilot Study.

Introduction Operating Room Black Box (ORBB) technology can be used to capture information during surgery for analysis and potential identification of root causes that jeopardize safety and efficiency. In this study, our objective was to identify and characterize procedural steps, intraoperative distractions, errors, and threats, as well as the non-technical skills of the team during a common minimally invasive gynecologic procedure. Methodology This was a cross-sectional pilot study of 25 patients undergoing total laparoscopic hysterectomy between May 2019 and February 2020 at a Canadian tertiary care academic hospital. Video, audio, and patient physiologic data from all procedures were obtained through a multichannel synchronized recording device (ORBB). Trained analysts reviewed and coded the recordings. Results The median total case time was 165 minutes (interquartile range [IQR]: 160-178 minutes) with the shortest step being cystoscopy and the longest being vaginal cuff closure. Time pressure and device absence or malfunction occurred in 48% of the cases, and a median of 262 (IQR: 228-304) auditory distractions were noted per case. There was a median of 3 (IQR: 2-4) safety threats identified per case and at least one error was identified in 11/25 cases (44%). Only two adverse events were noted among all 25 cases. Observed non-technical skills were mainly positive, and observations were the highest for situational awareness and leadership among the surgical team and communication and teamwork among the nursing/scrub technician and anesthesia teams. Conclusions This study is a novel application of the ORBB in the gynecology operating room to capture information regarding procedure times, intraoperative distractions, errors, and non-technical skills of the team. Frequent intraoperative cognitive and auditory distractions were noted. Although adverse events were rare, safety threats were identified. Ongoing and future research from our group will aim to identify key areas for organizational, technological, and team improvement to minimize inefficiencies and optimize patient safety in the operating room.