The impact of resident training on robotic operative times: is there a July Effect?

It is unknown whether the July Effect (a theory that medical errors and organizational inefficiencies increase during the influx of new surgical residents) exists in urologic robotic-assisted surgery. The aim of this study was to investigate the impact of urology resident training on robotic operative times at the beginning of the academic year. A retrospective chart review was conducted for urologic robotic surgeries performed at a single institution between 2008 and 2019. Univariate and multivariate mix model analyses were performed to determine the association between operative time and patient age, estimated blood loss, case complexity, robotic surgical system (Si or Xi), and time of the academic year. Differences in surgery time and non-surgery time were assessed with/without resident presence. Operative time intervals were included in the analysis. Resident presence correlated with increased surgery time (38.6 min (p < 0.001)) and decreased non-surgery time (4.6 min (p < 0.001)). Surgery time involving residents decreased by 8.7 min after 4 months into the academic year (July-October), and by an additional 5.1 min after the next 4 months (p = 0.027, < 0.001). When compared across case types stratified by complexity, surgery time for cases with residents significantly varied. Cases without residents did not demonstrate such variability. Resident presence was associated with prolonged surgery time, with the largest effect occurring in the first 4 months and shortening later in the year. However, resident presence was associated with significantly reduced non-surgery time. These results help to understand how new trainees impact operating room times.

Revealing complex interdependencies in surgical instrument reprocessing using SEIPS 101 tools.

Sterile Processing Departments (SPDs) must clean, maintain, store, and organize surgical instruments which are then delivered to Operating Rooms (ORs) using a Courier Network, with regular coordination occurring across departmental boundaries. To represent these relationships, we utilized the Systems Engineering Initiative for Patient Safety (SEIPS) 101 Toolkit, which helps model how health-related outcomes are affected by healthcare work systems. Through observations and interviews which built on prior work system analyses, we developed a SEIPS 101 journey map, PETT scan, and tasks matrices to represent the instrument reprocessing work system, revealing complex interdependencies between the people, tools, and tasks occurring within it. The SPD, OR and Courier teams are found to have overlapping responsibilities and a clear co-dependence, with critical implications for the successful functioning of the whole hospital system.

The movement of syringes and medication during anesthesiology delivery: An observational study in laparoscopic surgeries.

The movements of syringes and medications during an anesthetic case have yet to be systematically documented. We examine how syringes and medication move through the anesthesia work area during a case. We conducted a video-based observational study of 14 laparoscopic surgeries. We defined 'syringe events' as when syringe was picked up and moved. Medications were administered to the patient in only 48 (23.6%) of the 203 medication or syringe events. On average, 14.5 syringe movements occurred in each case. We estimate approximately 4.2 syringe movements for each medication administration. When a medication was administered to the patient (either through the IV pump or the patient port), it was picked up from one of 8 locations in the work area. Our study suggests that the syringe storage locations vary and include irregular locations (e.g., patient bed or provider's pockets). Our study contributes to understanding the complexity in the anesthesia work practices.

The IDEAL framework for surgical robotics: development, comparative evaluation and long-term monitoring.

The next generation of surgical robotics is poised to disrupt healthcare systems worldwide, requiring new frameworks for evaluation. However, evaluation during a surgical robot's development is challenging due to their complex evolving nature, potential for wider system disruption and integration with complementary technologies like artificial intelligence. Comparative clinical studies require attention to intervention context, learning curves and standardized outcomes. Long-term monitoring needs to transition toward collaborative, transparent and inclusive consortiums for real-world data collection. Here, the Idea, Development, Exploration, Assessment and Long-term monitoring (IDEAL) Robotics Colloquium proposes recommendations for evaluation during development, comparative study and clinical monitoring of surgical robots-providing practical recommendations for developers, clinicians, patients and healthcare systems. Multiple perspectives are considered, including economics, surgical training, human factors, ethics, patient perspectives and sustainability. Further work is needed on standardized metrics, health economic assessment models and global applicability of recommendations.

Anesthesia Workspaces for Safe Medication Practices: Design Guidelines.

BACKGROUND: Studies show that workspace for the anesthesia providers is prone to interruptions and distractions. Anesthesia providers experience difficulties while performing critical medication tasks such as medication preparation and administration due to poor ergonomics and configurations of workspace, equipment clutter, and limited space which ultimately may impact patient safety, length of surgery, and cost of care delivery. Therefore, improving design of anesthesia workspace for supporting safe and efficient medication practices is paramount. OBJECTIVES: The objective of this study was to develop a set of evidence-based design guidelines focusing on design of anesthesia workspace to support safer anesthesia medication tasks in operating rooms (ORs). METHODS: Data collection was based on literature review, observation, and coding of more than 30 prerecorded videos of outpatient surgical procedures to identify challenges experienced by anesthesia providers while performing medication tasks. Guidelines were then reviewed and validated using short survey. RESULTS: Findings are summarized into seven evidence-based design guidelines, including (1) locate critical tasks within a primary field of vision, (2) eliminate travel into and through the anesthesia zone (for other staff), (3) identify and demarcate a distinct anesthesia zone with adequate space for the anesthesia provider, (4) optimize the ability to reposition/reconfigure the anesthesia workspace, (5) minimize clutter from equipment, (6) provide adequate and appropriately positioned surfaces for medication preparation and administration, and (7) optimize task and surface lighting. CONCLUSION: This study finds many areas for improving design of ORs. Improvements of anesthesia work area will call for contribution and cooperation of entire surgical team.

Speech Communication Interference in the Operating Room.

INTRODUCTION: Operating room communication is frequently disrupted, raising safety concerns. We used a Speech Interference Instrument to measure the frequency, impact, and causes of speech communication interference (SCI) events. METHODS: In this prospective study, we observed 40 surgeries, primarily general surgery, to measure the frequency of SCI, defined as "group discourse disrupted according to the participants, the goals, or the physical and situational context of the exchange." We performed supplemental observations, focused on conducting postsurgery interviews with SCI event participants to identify contextual factors. We thematically analyzed notes and interviews. RESULTS: The observed 103 SCI events in 40 surgeries (mean 2.58) mostly involved the attending (50.5%), circulating nurse (44.6%), resident (44.6%), or scrub tech (42.7%). The majority (82.1%) of SCI events occurred during another patient-related task. 17.5% occurred at a critical moment. 27.2% of SCI events were not acknowledged or repeated and the message was lost. Including the supplemental observations, 97.0% of SCI events caused a delay (mean 5 s). Inter-rater reliability, calculated by Gwet's AC1 was 0.87-0.98. Postsurgery interviews confirmed miscommunication and distractions. Attention was most commonly diverted by loud noises (e.g., suction), conversations, or multitasking (e.g., using the electronic health record). Successful strategies included repetition or deferment of the request until competing tasks were complete. CONCLUSIONS: Communication interference may have patient safety implications that arise from conflicts with other case-related tasks, machine noises, and other conversations. Reorganization of workflow, tasks, and communication behaviors could reduce miscommunication and improve surgical safety and efficiency.

Associations of flow disruptions with patient, staff, and process outcomes: a prospective observational study of robotic-assisted radical prostatectomies.

BACKGROUND: Technological advancements in the operating room (OR) have sparked new challenges for surgical workflow, OR professionals, and patient safety. Disruptive events are frequent across all surgical specialties, but little is known about their effects on patient outcomes and the influence of systemic factors. The aim was to explore the associations of intraoperative flow disruptions (FDs) with patient outcomes, staff workload, and surgery duration. METHODS: Prospective, single-center, and multi-source study comprising direct and standardized OR observations of urologic surgical procedures, clinical patient outcomes, and staff- and patient-reported outcome data (PROMs; 3-month follow-up). All data were recorded between 01/2020 and 10/2021. FDs were assessed using standardized procedure observations. Linear and logistic regression analyses including multiple system factors were used to explore the effects of FDs on surgical outcomes. RESULTS: 61 robotic-assisted radical prostatectomy procedures were captured (with 61 patients and 243 staff reports). High rates of FDs were observed; however, our analyses did not show significant relationships with patient complication rates. Equipment- and patient-related FDs were associated with increased staff workload. No association was found between higher rates of FDs and procedure duration. CONCLUSIONS: FDs were not related to inferior patient outcomes. Our findings may inform future OR investigations that scrutinize the complex interplay of human, team, process, and technological components that mitigate the effects of FDs during surgery.

Demands of surgical teams in robotic-assisted surgery: An assessment of intraoperative workload within different surgical specialties.

BACKGROUND: Current approaches to assessing workload in robotic-assisted surgery (RAS) focus on surgeons and lack real-world data. Understanding how workload varies by role and specialty aids in identifying effective ways to optimize workload. METHODS: SURG-TLX surveys with six domains of workload were administered to surgical staff at three sites. Staff reported workload perceptions for each domain on a 20-point Likert scale, and aggregate scores were determined per participant. RESULTS: 188 questionnaires were obtained across 90 RAS procedures. Significantly higher aggregate scores were reported for gynecology (Mdn â€‹= â€‹30.00) (p â€‹= â€‹0.034) and urology (Mdn â€‹= â€‹36.50) (p â€‹= â€‹0.006) than for general (Mdn â€‹= â€‹25.00). Surgeons reported significantly higher scores for task complexity (Mdn â€‹= â€‹8.00) than both technicians (Mdn â€‹= â€‹5.00) (p â€‹= â€‹0.007), and nurses (Mdn â€‹= â€‹5.00). CONCLUSIONS: Staff reported significantly higher workload during urology and gynecology procedures, and experienced significant differences in domain workload by role and specialty, elucidating the need for tailored workload interventions.

Identifying Workflow Disruptions in Robotic-Assisted Bariatric Surgery: Elucidating Challenges Experienced by Surgical Teams.

PURPOSE: Bariatric surgery is an effective and durable treatment for weight loss for patients with extreme obesity. Although traditionally approached laparoscopically, robotic bariatric surgery (RBS) has unique benefits for both surgeons and patients. Nonetheless, the technological complexity of robotic surgery presents new challenges for OR teams and the wider clinical system. Further assessment of the role of RBS in delivering quality care for patients with obesity is necessary and can be done through a human factors approach. This observational study sought to investigate the impact of RBS on the surgical work system via the study of flow disruptions (FDs), or deviations from the natural workflow progression. MATERIALS AND METHODS: RBS procedures were observed between October 2019 and March 2022. FDs were recorded in real time and subsequently classified into one of nine work system categories. Coordination FDs were further classified into additional sub-categories. RESULTS: Twenty-nine RBS procedures were observed at three sites. An average FD rate of 25.05 (CI = ± 2.77) was observed overall. FDs were highest between insufflation and robot docking (M = 29.37, CI = ± 4.01) and between patient closing and wheels out (M = 30.00, CI = ± 6.03). FD rates due to coordination issues were highest overall, occurring once every 4 min during docking (M = 14.28, CI = ± 3.11). CONCLUSION: FDs occur roughly once every 2.4 min and happen most frequently during the final patient transfer and robot docking phases of RBS. Coordination challenges associated with waiting for staff/instruments not readily available and readjusting equipment contributed most to these disruptions.

A better way: training for direct observations in healthcare.

Direct observation is valuable for identifying latent threats and elucidating system complexity in clinical environments. This approach facilitates prospective risk assessment and reveals workarounds, near-misses and recurrent safety problems difficult to diagnose retrospectively or via outcome data alone. As observers are an instrument of data collection, developing effective and comprehensive observer training is critical to ensuring the reliability of the data collection and reproducibility of the research. However, methodological rigour for ensuring these data collection properties remains a key challenge in direct observation research in healthcare. Although prior literature has offered key considerations for observational research in healthcare, operationalising these recommendations may pose a challenge and unless guidance is also provided on observer training. In this article, we offer guidelines for training non-clinical observers to conduct direct observations including conducting a training needs analysis, incorporating practice observations and evaluating observers and inter-rater reliability. The operationalisation of these guidelines is described in the context of a 5-year multisite observational study investigating technology integration in the operating room. We also discuss novel tools developed during the course our project to support data collection and examine inter-rater reliability among observers in direct observation studies.

A Novel Approach for Engagement in Team Training in High-Technology Surgery: The Robotic-Assisted Surgery Olympics.

INTRODUCTION: There is ongoing interest in the development of technical and nontechnical skills in healthcare to improve safety and efficiency; however, barriers to developing and delivering related training programs make them difficult to implement. Unique approaches to training such as "serious games" may offer ways to motivate teams, reinforce skill acquisition, and promote teamwork. Given increased challenges to teamwork in robotic-assisted surgery (RAS), researchers aimed to develop the "RAS Olympics," a game-based educational competition to improve skills needed to successfully perform RAS. METHODS: This pilot study was conducted at an academic medical center in Southern California. Robotic-assisted surgery staff were invited to participate in the "RAS Olympics" to develop their skills and identify opportunities to improve processes. Impact of the activity was assessed using surveys and debriefs. RESULTS: Sixteen operating room team members participated and reacted favorably toward the RAS-Olympics (average score, 4.5/5). They enjoyed the activity, would recommend all staff participate, felt that it was relevant to their work, and believed that they practiced and learned new techniques that would improve their practice. Confidence in skills remained unchanged. Participants preferred the RAS Olympics to traditional training because it provided an interactive learning environment. CONCLUSIONS: The successful implementation of the RAS Olympics provided insight into new opportunities to engage surgical staff members while also training technical and nontechnical skills. Furthermore, this shared experience allowed surgical staff members to gain a greater appreciation for their teammates and an understanding of the current challenges and methods to improve teamwork and communication while promoting safety and efficiency in RAS.

Human Factors Integration in Robotic Surgery.

OBJECTIVE: Using the example of robotic-assisted surgery (RAS), we explore the methodological and practical challenges of technology integration in surgery, provide examples of evidence-based improvements, and discuss the importance of systems engineering and clinical human factors research and practice. BACKGROUND: New operating room technologies offer potential benefits for patients and staff, yet also present challenges for physical, procedural, team, and organizational integration. Historically, RAS implementation has focused on establishing the technical skills of the surgeon on the console, and has not systematically addressed the new skills required for other team members, the use of the workspace, or the organizational changes. RESULTS: Human factors studies of robotic surgery have demonstrated not just the effects of these hidden complexities on people, teams, processes, and proximal outcomes, but also have been able to analyze and explain in detail why they happen and offer methods to address them. We review studies on workload, communication, workflow, workspace, and coordination in robotic surgery, and then discuss the potential for improvement that these studies suggest within the wider healthcare system. CONCLUSION: There is a growing need to understand and develop approaches to safety and quality improvement through human-systems integration at the frontline of care.Precis: The introduction of robotic surgery has exposed under-acknowledged complexities of introducing complex technology into operating rooms. We explore the methodological and practical challenges, provide examples of evidence-based improvements, and discuss the implications for systems engineering and clinical human factors research and practice.

RAS-NOTECHS: validity and reliability of a tool for measuring non-technical skills in robotic-assisted surgery settings.

BACKGROUND: Non-technical skills (NTS) are essential for safe surgical practice as they impact workflow and patient outcomes. Observational tools to measure operating room (OR) teams' NTS have been introduced. However, there are none that account for the specific teamwork challenges introduced by robotic-assisted surgery (RAS). We set out to develop and content-validate a tool to assess multidisciplinary NTS in RAS. METHODOLOGY: Stepwise, multi-method procedure. Observations in different surgical departments and a scoping literature review were first used to compile a set of RAS-specific teamwork behaviours. This list was refined and expert validated using a Delphi consensus approach consisting of qualitative interviews and a quantitative survey. Then, RAS-specific behaviours were merged with a well-established assessment tool on OR teamwork (NOTECHS II). Finally, the new tool-RAS-NOTECHS-was applied in standardized observations of real-world procedures to test its reliability (inter-rater agreement via intra-class correlations). RESULTS: Our scoping review revealed 5242 articles, of which 21 were included based on pre-established inclusion criteria. We elicited 16 RAS-specific behaviours from the literature base. These were synthesized with further 18 behavioural markers (obtained from 12 OR-observations) into a list of 26 behavioural markers. This list was reviewed by seven RAS experts and condensed to 15 expert-validated RAS-specific behavioural markers which were then merged into NOTECHS II. For five observations of urologic RAS procedures (duration: 13 h and 41 min), inter-rater agreement for identification of behavioural markers was strong. Agreement of RAS-NOTECHS scores indicated moderate to strong agreement. CONCLUSIONS: RAS-NOTECHS is the first observational tool for multidisciplinary NTS in RAS. In preliminary application, it has been shown to be reliable. Since RAS is rapidly increasing and challenges for effective and safe teamwork remain at the forefront of quality and safety of surgical care, RAS-NOTECHS may contribute to training and improvement efforts in technology-facilitated surgeries.

Addressing misconceptions of flow disruption studies in "Is non-stop always better? Examining assumptions behind the concept of flow disruptions in studies of robot-assisted surgery".

This letter to the editor provides a response to "Is non-stop always better? Examining assumptions behind the concept of flow disruptions in studies of robot-assisted surgery." The authors provide much needed clarification on misconceptions of flow disruption studies. The evolving methodology is not aimed at creating a "non-stop" flow, or optimizing efficiency, but understanding the clinical process from a systems perspective.

Using flow disruptions to understand healthcare system safety: A systematic review of observational studies.

This systematic review provides information on the methodologies, measurements and classification systems used in observational studies of flow disruptions in clinical environments. The PRISMA methodology was applied and authors searched two databases (PubMed and Web of Science) for studies meeting the following inclusion criteria: (a) were conducted in a healthcare setting, (b) explored systems-factors leading to deviations in care processes, (c) were prospective and observational, (d) classified observations, and (e) were original research studies published in peer-reviewed journals. Thirty studies were analyzed and a variety of methods were identified for observer training, data collection and observation classification. Although primarily applied in surgery, comparable research has been successfully conducted in other venues such as trauma care, and delivery rooms. The findings of this review were synthesized into a framework of considerations for conducting rigorous methodological studies aimed at understanding clinical systems.

A Smartphone Application for Teamwork and Communication in Trauma: Pilot Evaluation "in the Wild".

OBJECTIVE: To evaluate the potential for a smartphone application to improve trauma care through shared and timely access to patient and contextual information. BACKGROUND: Disruptions along the trauma pathway that arise from communication, coordination, and handoffs problems can delay progress through initial care, imaging diagnosis, and surgery to intensive care unit (ICU) disposition. Implementing carefully designed and evaluated information distribution and communication technologies may afford opportunities to improve clinical performance. METHODS: This was a pilot evaluation "in the wild" using a before/after design, 3 month, and pre- post-intervention data collection. Use statistics, usability assessment, and direct observation of trauma care were used to evaluate the app. Ease of use and utility were assessed using the technology acceptance model (TAM) and system usability scale (SUS). Direct observation deployed measures of flow disruptions (defined as "deviations from the natural progression of an procedure"), teamwork scores (T-NOTECHS), and treatment times (total time in emergency department [ED]). RESULTS: The app was used in 367 (87%) traumas during the trial period. Usability was generally acceptable, with higher scores found by operating room (OR), ICU, and neuro and orthopedic users. Despite positive trends, no significant effects on flow disruptions, teamwork scores, or treatment times were observed. CONCLUSIONS: Pilot trials of a clinician-centered smartphone app to improve teamwork and communication demonstrate potential value for the safety and efficiency of trauma care delivery as well as benefits and challenges of "in-the-wild" evaluation.

Barriers to safety and efficiency in robotic surgery docking.

BACKGROUND: The introduction of new technology into the operating room (OR) can be beneficial for patients, but can also create new problems and complexities for physicians and staff. The observation of flow disruptions (FDs)-small deviations from the optimal course of care-can be used to understand how systems problems manifest. Prior studies showed that the docking process in robotic assisted surgery (RAS), which requires careful management of process, people, technology and working environment, might be a particularly challenging part of the operation. We sought to explore variation across multiple clinical sites and procedures; and to examine the sources of those disruptions. METHODS: Trained observers recorded FDs during 45 procedures across multiple specialties at three different hospitals. The rate of FDs was compared across surgical phases, sites, and types of procedure. A work-system flow of the RAS docking procedure was used to determine which steps were most disrupted. RESULTS: The docking process was significantly more disrupted than other procedural phases, with no effect of hospital site, and a potential interaction with procedure type. Particular challenges were encountered in room organization, retrieval of supplies, positioning the patient, and maneuvering the robot. CONCLUSIONS: Direct observation of surgical procedures can help to identify approaches to improve the design of technology and procedures, the training of staff, and configuration of the OR environment, with the eventual goal of improving safety, efficiency and teamwork in high technology surgery.

Room Size Influences Flow in Robotic-Assisted Surgery.

The introduction of surgical technology into existing operating rooms (ORs) can place novel demands on staff and infrastructure. Despite the substantial physical size of the devices in robotic-assisted surgery (RAS), the workspace implications are rarely considered. This study aimed to explore the impact of OR size on the environmental causes of surgical flow disruptions (FDs) occurring during RAS. Fifty-six RAS procedures were observed at two academic hospitals between July 2019 and January 2021 across general, urologic, and gynecologic surgical specialties. A multiple regression analysis demonstrated significant effects of room size in the pre-docking phase (t = 2.170, df = 54, ß = 0.017, p = 0.035) where the rate of FDs increased as room size increased, and docking phase (t = -2.488, df = 54, ß = -0.017, p = 0.016) where the rate of FDs increased as room size decreased. Significant effects of site (pre-docking phase: p = 0.000 and docking phase: p = 0.000) were also demonstrated. Findings from this study demonstrate hitherto unrecognized spatial challenges involved with introducing surgical robots into the operating domain. While new technology may provide benefits towards patient safety, it is important to consider the needs of the technology prior to integration.

Using Flow Disruptions to Examine System Safety in Robotic-Assisted Surgery: Protocol for a Stepped Wedge Crossover Design.

BACKGROUND: The integration of high technology into health care systems is intended to provide new treatment options and improve the quality, safety, and efficiency of care. Robotic-assisted surgery is an example of high technology integration in health care, which has become ubiquitous in many surgical disciplines. OBJECTIVE: This study aims to understand and measure current robotic-assisted surgery processes in a systematic, quantitative, and replicable manner to identify latent systemic threats and opportunities for improvement based on our observations and to implement and evaluate interventions. This 5-year study will follow a human factors engineering approach to improve the safety and efficiency of robotic-assisted surgery across 4 US hospitals. METHODS: The study uses a stepped wedge crossover design with 3 interventions, introduced in different sequences at each of the hospitals over four 8-month phases. Robotic-assisted surgery procedures will be observed in the following specialties: urogynecology, gynecology, urology, bariatrics, general, and colorectal. We will use the data collected from observations, surveys, and interviews to inform interventions focused on teamwork, task design, and workplace design. We intend to evaluate attitudes toward each intervention, safety culture, subjective workload for each case, effectiveness of each intervention (including through direct observation of a sample of surgeries in each observational phase), operating room duration, length of stay, and patient safety incident reports. Analytic methods will include statistical data analysis, point process analysis, and thematic content analysis. RESULTS: The study was funded in September 2018 and approved by the institutional review board of each institution in May and June of 2019 (CSMC and MDRH: Pro00056245; VCMC: STUDY 270; MUSC: Pro00088741). After refining the 3 interventions in phase 1, data collection for phase 2 (baseline data) began in November 2019 and was scheduled to continue through June 2020. However, data collection was suspended in March 2020 due to the COVID-19 pandemic. We collected a total of 65 observations across the 4 sites before the pandemic. Data collection for phase 2 was resumed in October 2020 at 2 of the 4 sites. CONCLUSIONS: This will be the largest direct observational study of surgery ever conducted with data collected on 680 robotic surgery procedures at 4 different institutions. The proposed interventions will be evaluated using individual-level (workload and attitude), process-level (perioperative duration and flow disruption), and organizational-level (safety culture and complications) measures. An implementation science framework is also used to investigate the causes of success or failure of each intervention at each site and understand the potential spread of the interventions. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/25284.