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Objective: Clinical trials play a critical role in the rapidly evolving field of cardiothoracic surgery and the American Association of Thoracic Surgery (AATS) Clinical Trials Methods Course has provided a biannual symposium led by preeminent surgeons with vast experience in planning, conducting and analyzing surgical clinical trials. This study hypothesizes that participation in the course is associated with future success in clinical trial leadership., Methods: A list of course attendees (2014-2022) was queried in "ClinicalTrials.gov", a database of clinical trials funded by the United States Health and Human Services and the National Institutes of Health. The type of clinical trial and publications from the trial were collected. Demographic information about the participants were collected from faculty pages., Results: A total of 107 participants from various professional backgrounds attended the AATS Clinical Trials course and led 91 clinical trials. The average time to starting a clinical trial after attending the workshop was 3.04 years for participants who had not already been involved with a trial. Of the 107 participants, 36 (36/107; 33.6%) were either the principal investigator or a sub-investigator for 91 clinical trials., Conclusions: The AATS Clinical Trials course provides participants the tools for successfully leading surgical clinical trials. Although participation has been limited, those who attend the course and lead a clinical trial do so within approximately 3 years. The Clinical Trials course provides an excellent return on investment and the AATS should continue sponsorship of this program as it supports the develop of future leaders in cardiothoracic surgery., (Copyright © 2024. Published by Elsevier Inc.)

Introduction: Controversy surrounds the long-term clinical benefit of coronary artery bypass grafting (CABG) using dual arterial grafts (DAGs) compared to single arterial grafts (SAGs). We investigated outcomes of DAG, using single internal thoracic artery and radial artery (DAG-RA) or bilateral internal thoracic artery grafts (DAG-BITA), compared to SAG, using the left internal thoracic artery and saphenous vein grafts, in the U.S. Veterans Health Administration (VA)., Methods: We conducted a cross-sectional study of U.S. Veterans undergoing isolated on-pump CABG between 2005 and 2015 at 44 VA medical centers. The primary composite outcome was first occurrence of a major adverse cardiac and cerebrovascular event (MACCE), comprised of death from any cause, myocardial infarction, stroke, or repeat revascularization., Results: Among 25,969 Veterans undergoing isolated CABG, 1261 (4.9%) underwent DAG (66.8% DAG-RA and 33.2% DAG-BITA). Over a 5-y follow-up, DAG was associated with lower rates of all-cause death (adjusted hazard ratio [AHR] 0.70, 95% confidence interval [CI] 0.58-0.85), MACCE (AHR 0.80, 95% CI 0.71-0.91), and stroke (AHR 0.74, 95% CI 0.57-0.96) versus SAG. DAG-BITA was associated with lower rates of all-cause death (AHR 0.52, 95% CI 0.35-0.77) and MACCE (AHR 0.66, 95% CI 0.51-0.84) than SAG, while DAG-RA was associated with lower rates of all-cause death (AHR 0.79, 95% CI 0.64-0.99)., Conclusions: In the VA, DAG was associated with improved long-term MACCE outcomes compared to SAG. These results suggest that the practice of DAG in the VA benefits Veterans and should be promoted further., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Objective: To investigate the association between the presence and grafting of chronic total occlusions (CTOs) and coronary artery bypass grafting (CABG) outcomes., Methods: This was a post hoc analysis of the Randomized Endograft vs Open Prospective (REGROUP) trial, which randomized veterans undergoing isolated on-pump CABG to endoscopic versus open vein harvest (2014-2017). Patients were stratified on the basis of the presence of at least 1 CTO vessel (a 100% occluded coronary lesion for greater than or equal to 3 months) and according to whether all CTO vessels were bypassed. Rates of major cardiac adverse events (MACE) were compared., Results: At least 1 CTO was present in 453 of 1149 patients (39.4%). Over a median follow-up of 4.7 years (interquartile range, 3.84-5.45), MACE rates were 23.4% versus 22.2% for the CTO versus no CTO group, respectively (adjusted hazard ratio [aHR], 0.92; 95% confidence interval [CI], 0.70-1.20). MACE rates for patients with complete CTO grafting versus not were 23.1% versus 25.0%, respectively (aHR, 0.95; 95% CI, 0.57-1.57). In patients with right coronary dominance undergoing left anterior descending artery grafting, bypassing a right coronary artery CTO was associated with significantly lower rates of all-cause mortality (aHR, 0.38; 95% CI, 0.17-0.83)., Conclusions: In this REGROUP trial subanalysis, neither CTO presence or complete grafting of CTO vessels was associated with significantly different rates of MACE. However, the finding of possible survival benefit among a subgroup of patients undergoing grafting of a dominant RCA CTO vessel alongside left anterior descending artery grafting warrants additional study., Competing Interests: Conflict of Interest Statement The authors reported no conflicts of interest. The Journal policy requires editors and reviewers to disclose conflicts of interest and to decline handling or reviewing manuscripts for which they may have a conflict of interest. The editors and reviewers of this article have no conflicts of interest., (Copyright © 2024 The American Association for Thoracic Surgery. All rights reserved.)

Objective: To characterize cognitive workload (CWL) of cardiac surgery team members in a real-world setting during coronary artery bypass grafting (CABG) surgery using providers' heart rate variability (HRV) data as a surrogate measure of CWL., Methods: HRV was collected from the surgeon, anesthesiologist, perfusionist, and scrub nurse, and audio/video recordings were made during isolated, nonemergency CABG surgeries (n = 27). Eight surgical phases were annotated by trained researchers, and HRV was calculated for each phase., Results: Significant differences in CWL were observed within a given role across surgical phases. Results are reported as predicted probability (95% confidence interval [CI]). CWL was significantly higher for anesthesiologists during "preparation and induction" (0.57; 95% CI, 0.42-0.71) and "anastomoses" (0.44; 95% CI, 0.30-0.58) compared to other phases, and the same held for nurses during the "opening" (0.51; 95% CI, 0.37-0.65) and "postoperative" (0.68; 95% CI, 0.42-0.86) phases. Additional significant differences were observed between roles within a given surgical phase. For example, surgeons had significantly higher CWL during "anastomoses" (0.81; 95% CI, 0.69-0.89) compared to all other phases, and the same was true of perfusionists during the "opening" (0.79; 95% CI, 0.66-0.88) and "prebypass preparation" (0.50; 95% CI, 0.36-0.64) phases., Conclusions: Our innovative analysis demonstrates that CWL fluctuates across surgical procedures by role and phase, which may reflect the distribution of primary tasks. This corroborates earlier findings from self-report measures. The data suggest that team-wide, peak CWL during a phase decreases from early phases of surgery through initiation of cardiopumonary bypass (CPB), rises during anastomosis, and decreases after termination of CPB. Knowledge of these trends could encourage the adoption of behaviors to enhance team dynamics and performance., Competing Interests: Conflict of Interest Statement The authors reported no conflicts of interest. The Journal policy requires editors and reviewers to disclose conflicts of interest and to decline handling or reviewing manuscripts for which they may have a conflict of interest. The editors and reviewers of this article have no conflicts of interest., (Copyright © 2024 The American Association for Thoracic Surgery. All rights reserved.)

This case report describes the perioperative course of a patient undergoing emergency repair of acute type A thoracic aortic dissection. Andexanet alfa was administered intraoperatively to obtain a dry operative field for right axillary artery exposure and cannulation. Andexanet alfa-induced heparin resistance resulted in cardiopulmonary bypass circuit and pericardial thrombosis requiring more than 400,000 units of unfractionated heparin and antithrombin III to overcome. Postoperatively, excessive chest tube output was observed secondary to protracted heparin rebound requiring continuous dosing of protamine. This case demonstrates the significant challenging perioperative, not just intraoperative, hazards associated with intraoperative andexanet alfa use during emergency cardiac surgery with cardiopulmonary bypass., Competing Interests: Declaration of conflicting interestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: JMC: J.M. Connors reports research funding to the institution from CSL Behring, personal fees from Abbott, Anthos, Bristol Myers Squibb, Pfizer, Roche, Sanofi, Werfen.

Importance: Assessing nontechnical skills in operating rooms (ORs) is crucial for enhancing surgical performance and patient safety. However, automated and real-time evaluation of these skills remains challenging., Objective: To explore the feasibility of using motion features extracted from surgical video recordings to automatically assess nontechnical skills during cardiac surgical procedures., Design, Setting, and Participants: This cross-sectional study used video recordings of cardiac surgical procedures at a tertiary academic US hospital collected from January 2021 through May 2022. The OpenPose library was used to analyze videos to extract body pose estimations of team members and compute various team motion features. The Non-Technical Skills for Surgeons (NOTSS) assessment tool was employed for rating the OR team's nontechnical skills by 3 expert raters., Main Outcomes and Measures: NOTSS overall score, with motion features extracted from surgical videos as measures., Results: A total of 30 complete cardiac surgery procedures were included: 26 (86.6%) were on-pump coronary artery bypass graft procedures and 4 (13.4%) were aortic valve replacement or repair procedures. All patients were male, and the mean (SD) age was 72 (6.3) years. All surgical teams were composed of 4 key roles (attending surgeon, attending anesthesiologist, primary perfusionist, and scrub nurse) with additional supporting roles. NOTSS scores correlated significantly with trajectory (r = 0.51, P = .005), acceleration (r = 0.48, P = .008), and entropy (r = -0.52, P = .004) of team displacement. Multiple linear regression, adjusted for patient factors, showed average team trajectory (adjusted R2 = 0.335; coefficient, 10.51 [95% CI, 8.81-12.21]; P = .004) and team displacement entropy (adjusted R2 = 0.304; coefficient, -12.64 [95% CI, -20.54 to -4.74]; P = .003) were associated with NOTSS scores., Conclusions and Relevance: This study suggests a significant link between OR team movements and nontechnical skills ratings by NOTSS during cardiac surgical procedures, suggesting automated surgical video analysis could enhance nontechnical skills assessment. Further investigation across different hospitals and specialties is necessary to validate these findings.

Objective: To determine the prevalence of clinical significance reporting in contemporary comparative effectiveness research (CER)., Background: In CER, a statistically significant difference between study groups may or may not be clinically significant. Misinterpreting statistically significant results could lead to inappropriate recommendations that increase health care costs and treatment toxicity., Methods: CER studies from 2022 issues of the Annals of Surgery , Journal of the American Medical Association , Journal of Clinical Oncology , Journal of Surgical Research , and Journal of the American College of Surgeons were systematically reviewed by 2 different investigators. The primary outcome of interest was whether the authors specified what they considered to be a clinically significant difference in the "Methods.", Results: Of 307 reviewed studies, 162 were clinical trials and 145 were observational studies. Authors specified what they considered to be a clinically significant difference in 26 studies (8.5%). Clinical significance was defined using clinically validated standards in 25 studies and subjectively in 1 study. Seven studies (2.3%) recommended a change in clinical decision-making, all with primary outcomes achieving statistical significance. Five (71.4%) of these studies did not have clinical significance defined in their methods. In randomized controlled trials with statistically significant results, sample size was inversely correlated with effect size ( r = -0.30, P = 0.038)., Conclusions: In contemporary CER, most authors do not specify what they consider to be a clinically significant difference in study outcome. Most studies recommending a change in clinical decision-making did so based on statistical significance alone, and clinical significance was usually defined with clinically validated standards., Competing Interests: The authors report no conflicts of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Objectives: Performance of a technically sound left internal thoracic artery to left anterior descending artery (LITA-LAD) anastomosis during coronary artery bypass grafting (CABG) is critically important. We used prospectively collected data from the multicentre, randomized REGROUP (Randomized Endograft Vein Perspective) trial to investigate CABG outcomes based on whether a resident or an attending surgeon performed the LITA-LAD anastomosis., Methods: This was a post hoc subanalysis of the REGROUP trial, which randomized veterans undergoing isolated on-pump CABG to endoscopic versus open vein harvest from 2014 through 2017. The primary end point was major cardiac adverse events, defined as the composite of all-cause deaths, nonfatal myocardial infarctions or repeat revascularizations., Results: Among 1,084 patients, 344 (31.8%) LITA-LAD anastomoses were performed by residents and 740 (68.2%), by attending surgeons. Residents (compared to attendings) operated on fewer patients with high tercile SYNTAX scores (22.1% vs 37.4%, P < 0.001), performed fewer multiarterial CABGs (5.2% vs 14.6%, P < 0.001) and performed more anastomoses to distal targets with diameters > 2.0 mm (19.0% vs 10.9%, P < 0.001) and non-calcified landing zones (25.1% vs 21.6%, P < 0.001). During a median observation time of 4.7 years (interquartile range 3.84-5.45), major cardiac adverse events occurred in 77 patients (22.4%) in the group treated by residents and 169 patients (22.8%) in the group treated by attendings (unadjusted HR 1.00; 95% confidence interval, 0.76-1.33; P = 0.99). Outcomes persisted on adjusted analyses., Conclusions: Based on this REGROUP trial subanalysis, under careful supervision and with appropriate patient selection, LITA-LAD anastomoses performed by the residents yielded clinical outcomes similar to those of the attendings., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

There is growing evidence in support of coronary complete revascularization (CR). Nonetheless, there is no universally accepted definition of CR in patients who undergo coronary bypass grafting surgery (CABG). We sought to investigate the outcomes of CR, defined as surgical revascularization of any territory supplied by a suitable coronary artery with ≥50% stenosis. We performed a preplanned subanalysis in the Randomized Trial of Endoscopic or Open Saphenous Vein Graft Harvesting (REGROUP) clinical trial cohort. Of 1,147 patients who underwent CABG, 810 (70.6%) received CR. The primary outcome was a composite of major adverse cardiac events (MACEs), including death from any cause, nonfatal myocardial infarction, or repeat revascularization over a median 4.7 years of follow-up. MACE occurred in 175 patients (21.6%) in the CR group and 86 patients (25.5%) in the incomplete revascularization (IR) group (hazard ratio [HR] 0.87, 95% confidence interval [CI] 0.67 to 1.13, p = 0.29). A total of 97 patients (12.0%) in the CR group and 48 patients (14.2%) in the IR group died (HR 0.93, 95% CI 0.65 to 1.32, p = 0.67); nonfatal myocardial infarction occurred in 49 patients (6.0%) in the CR group and 30 patients (8.9%) in the IR group (HR 0.76, 95% CI 0.48 to 1.2, p = 0.24), and repeat revascularization occurred in 62 patients (7.7%) in the CR group and 39 patients (11.6%) in the IR group (HR 0.64; 95% CI 0.42 to 0.95, p = 0.027). In conclusion, in patients with a great burden of co-morbidities who underwent CABG in the REGROUP trial over a median follow-up period of a median 4.7 years, CR was associated with similar MACE rates but a reduced risk of repeat revascularization. Longer-term follow-up is warranted., Competing Interests: Declaration of competing interest The authors have no competing interests to declare., (Published by Elsevier Inc.)

Introduction: The impact of postoperative oral anticoagulation (OAC) with warfarin on postoperative atrial fibrillation (POAF) after coronary artery bypass grafting (CABG) was the focus of this examination of patients from the randomized endo-vein graft prospective (REGROUP) Trial., Material and Methods: REGROUP was a prospective randomized Veterans Affairs cooperative study comparing endoscopic versus open vein harvest in elective CABG patients (March 2014-April 2017) at 16 Veterans Affairs facilities. This study compared new-onset POAF patients who were treated with warfarin versus no-warfarin. Outcomes included stroke during active follow-up and a major adverse cardiac event composite of mortality, acute myocardial infarction, and repeat revascularization during active and passive follow-up., Results: Of the 316/1103 (28.6%) of REGROUP patients who developed new-onset POAF, 45 patients were excluded - mainly for preoperative warfarin use. Of the remaining 269 patients, 85 received OAC with warfarin (OAC group); 184 did not (no-OAC group). Stroke rates during active follow-up (32 [IQR 24-38] mo) were 3.5% OAC group versus 5.4% no-OAC group (P = 0.76); major adverse cardiac eventrates were 20% OAC versus 11.4% no-OAC (P = 0.06). On longer follow-up of (median 4.61 [IQR 3.9-5.1] y), discharge OAC use was associated with all-cause mortality after adjusting for Society of Thoracic Surgeons mortality risk (20.0% versus 11.4% no-OAC use; HR = 2.00, 95% CI: 1.05-3.81, P = 0.035)., Conclusions: REGROUP patients with POAF treated with OAC had similar stroke and higher mortality rates versus no-OAC patients. Further investigation of the risk-benefit ratio of OAC in post-CABG patients and which POAF patient subgroups might derive the most benefit with anticoagulation appears warranted., (Published by Elsevier Inc.)

This study focuses on understanding the influence of cognitive biases in the intra-operative decision-making process within cardiac surgery teams, recognizing the complexity and high-stakes nature of such environments. We aimed to investigate the perceived prevalence and impact of cognitive biases among cardiac surgery teams, and how these biases may affect intraoperative decisions and patient safety and outcomes. A mixed-methods approach was utilized, combining quantitative ratings across 32 different cognitive biases (0 to 100 visual analogue scale), regarding their "likelihood of occurring" and "potential for patient harm" during the intraoperative phase of cardiac surgery. Based on these ratings, we collected qualitative insights on the most-rated cognitive biases from semi-structured interviews with surgeons, anaesthesiologists, and perfusionists who work in a cardiac operating room. A total of 16 participants, including cardiac surgery researchers and clinicians, took part in the study. We found a significant presence of cognitive biases, particularly confirmation bias and overconfidence, which influenced decision-making processes and had the potential for patient harm. Of 32 cognitive biases, 6 were rated above the 75th percentile for both criteria (potential for patient harm, likelihood of occurring). Our preliminary findings provide a first step toward a deeper understanding of the complex cognitive mechanisms that underlie clinical reasoning and decision-making in the operating room. Future studies should further explore this topic, especially the relationship between the occurrence of intraoperative cognitive biases and postoperative surgical outcomes. Additionally, the impact of metacognition strategies (e.g. debiasing training) on reducing the impact of cognitive bias and improving intraoperative performance should also be investigated.

The cardiac operating room (OR) is a high-risk, high-stakes environment inserted into a complex socio-technical healthcare system. During cardiopulmonary bypass (CPB), the most critical phase of cardiac surgery, the perfusionist has a crucial role within the interprofessional OR team, being responsible for optimizing patient perfusion while coordinating other tasks with the surgeon, anesthesiologist, and nurses. The aim of this study was to investigate objective digital biomarkers of perfusionists' workload and stress derived from heart rate variability (HRV) metrics captured via a wearable physiological sensor in a real cardiac OR. We explored the relationships between several HRV parameters and validated self-report measures of surgical task workload (SURG-TLX) and acute stress (STAI-SF), as well as surgical processes and outcome measures. We found that the frequency-domain HRV parameter HF relative power - FFT (%) presented the strongest association with task workload (correlation coefficient: -0.491, p-value: 0.003). We also found that the time-domain HRV parameter RMSSD (ms) presented the strongest correlation with perfusionists' acute stress (correlation coefficient: -0.489, p-value: 0.005). A few workload and stress biomarkers were also associated with bypass time and patient length of stay in the hospital. The findings from this study will inform future research regarding which HRV-based biomarkers are best suited for the development of cognitive support systems capable of monitoring surgical workload and stress in real time.

Clinical alarm and decision support systems that lack clinical context may create non-actionable nuisance alarms that are not clinically relevant and can cause distractions during the most difficult moments of a surgery. We present a novel, interoperable, real-time system for adding contextual awareness to clinical systems by monitoring the heart-rate variability (HRV) of clinical team members. We designed an architecture for real-time capture, analysis, and presentation of HRV data from multiple clinicians and implemented this architecture as an application and device interfaces on the open-source OpenICE interoperability platform. In this work, we extend OpenICE with new capabilities to support the needs of the context-aware OR including a modularized data pipeline for simultaneously processing real-time electrocardiographic (ECG) waveforms from multiple clinicians to create estimates of their individual cognitive load. The system is built with standardized interfaces that allow for free interchange of software and hardware components including sensor devices, ECG filtering and beat detection algorithms, HRV metric calculations, and individual and team alerts based on changes in metrics. By integrating contextual cues and team member state into a unified process model, we believe future clinical applications will be able to emulate some of these behaviors to provide context-aware information to improve the safety and quality of surgical interventions.

Several studies have reported low adherence and high resistance from clinicians to adopt digital health technologies into clinical practice, particularly the use of computer-based clinical decision support systems. Poor usability and lack of integration with the clinical workflow have been identified as primary issues. Few guidelines exist on how to analyze the collected data associated with the usability of digital health technologies. In this study, we aimed to develop a coding framework for the systematic evaluation of users' feedback generated during focus groups and interview sessions with clinicians, underpinned by fundamental usability principles and design components. This codebook also included a coding category to capture the user's clinical role associated with each specific piece of feedback, providing a better understanding of role-specific challenges and perspectives, as well as the level of shared understanding across the multiple clinical roles. Furthermore, a voting system was created to quantitatively inform modifications of the digital system based on usability data. As a use case, we applied this method to an electronic cognitive aid designed to improve coordination and communication in the cardiac operating room, showing that this framework is feasible and useful not only to better understand suboptimal usability aspects, but also to recommend relevant modifications in the design and development of the system from different perspectives, including clinical, technical, and usability teams. The framework described herein may be applied in other highly complex clinical settings, in which digital health systems may play an important role in improving patient care and enhancing patient safety.

Excessive intra-operative noise in cardiac surgery has the potential to serve as source of distraction and additional cognitive workload for the surgical team, and may interfere with optimal performance. The separation from bypass phase is a technically complex phase of surgery, making it highly susceptible to communication breakdowns due to high cognitive demands and requiring tightly coupled team coordination. The objective of this study was to investigate team cognitive workload levels and communication in relation to intra-operative time periods representative of infrequent vs. frequent peaks in ambient noise. Compared to 5-minute segments with no peaks in noise at all, segments with the highest percentage of noise peaks (≥10%) were significantly associated with higher team members' heart rate before, during, and after noise segments analyzed. These noisier segments were also associated with a significantly higher level of case-irrelevant communication events. These data suggest that case-irrelevant conversations associated with a greater degree of excessive peaks in noise may be associated with team workload levels, warranting further investigation into efforts to standardize communication during critical surgical phases.

Situational awareness (SA) at both individual and team levels, plays a critical role in the operating room (OR). During the pre-incision time-out, the entire OR team comes together to deploy the surgical safety checklist (SSC). Worldwide, the implementation of the SSC has been shown to reduce intraoperative complications and mortality among surgical patients. In this study, we investigated the feasibility of applying computer vision analysis on surgical videos to extract team motion metrics that could differentiate teams with good SA from those with poor SA during the pre-incision time-out. We used a validated observation-based tool to assess SA, and a computer vision software to measure body position and motion patterns in the OR. Our findings showed that it is feasible to extract surgical team motion metrics captured via off-the-shelf OR cameras. Entropy as a measure of the level of team organization was able to distinguish surgical teams with good and poor SA. These findings corroborate existing studies showing that computer vision-based motion metrics have the potential to integrate traditional observation-based performance assessments in the OR.

Importance: Value-based purchasing creates pressure to examine whether newer technologies and care processes, including new surgical techniques, yield any economic advantage., Objective: To compare health care costs and utilization between participants randomized to receive endoscopic vein harvesting (EVH) or open vein harvesting (OVH) during a coronary artery bypass grafting (CABG) procedure., Design, Setting, and Participants: This secondary economic analysis was conducted alongside the 16-site Randomized Endo-Vein Graft Prospective (REGROUP) clinical trial funded by the Department of Veterans Affairs (VA) Cooperative Studies Program. Adults scheduled for urgent or elective bypass involving a vein graft were eligible. The first participant was enrolled in September 2013, with most sites completing enrollment by March 2014. The last participant was enrolled in April 2017. A total of 1150 participants were randomized, with 574 participants receiving OVH and 576 receiving EVH. For this secondary analysis, cost and utilization data were extracted through September 30, 2020. Participants were linked to administrative data in the VA Corporate Data Warehouse and activity-based cost data starting with the index procedure., Interventions: EVH vs OVH, with comparisons based on intention to treat., Main Outcomes and Measures: Discharge costs for the index procedure as well as follow-up costs (including intended and unintended events; mean [SD] follow-up time, 33.0 [19.9] months) were analyzed, with results from different statistical models compared to test for robustness (ie, lack of variation across models). All costs represented care provided or paid by the VA, standardized to 2020 US dollars., Results: Among 1150 participants, the mean (SD) age was 66.4 (6.9) years; most participants (1144 [99.5%] were male. With regard to race and ethnicity, 6 participants (0.5%) self-reported as American Indian or Alaska Native, 10 (0.9%) as Asian or Pacific Islander, 91 (7.9%) as Black, 62 (5.4%) as Hispanic, 974 (84.7%) as non-Hispanic White, and 6 (0.5%) as other race and/or ethnicity; data were missing for 1 participant (0.1%). The unadjusted mean (SD) costs for the index CABG procedure were $76 607 ($43 883) among patients who received EVH and $75 368 ($45 900) among those who received OVH, including facility costs, insurance costs, and physician-related costs (commonly referred to as provider costs in Centers for Medicare and Medicaid and insurance data). No significant differences were found in follow-up costs; per 90-day follow-up period, EVH was associated with a mean (SE) added cost of $302 ($225) per patient. The results were highly robust to the statistical model., Conclusions and Relevance: In this study, EVH was not associated with a reduction in costs for the index CABG procedure or follow-up care. Therefore, the choice to provide EVH may be based on surgeon and patient preferences., Trial Registration: ClinicalTrials.gov Identifier: NCT01850082.

Background: Monitoring oxygen delivery to the oxygenator of a heart lung machine (HLM) is typically accomplished with an O 2 analyzer connected to the gas inflow line. It is assumed when the FiO 2 is greater than 21% that oxygen is being delivered to the oxygenator. However, this assumption is imperfect because the connection of the inflow line to the oxygenator is downstream from the O 2 analyzer. FiO 2 monitoring will not alert the perfusionist if the inflow line is not actually connected to the oxygenator. Measuring the fraction of expired oxygen (FEO 2 ) is a more reliable way of monitoring O 2 delivery., Methods: An O 2 analyzer was placed on the scavenging line that is attached to the exhaust port of oxygenator (FEO 2 )., Results: Whenever the FiO 2 is greater than 21%, and the inflow line is properly connected, the FEO 2 exiting the oxygenator is greater than 21%. The FEO 2 falls to 21% when the inflow line is not functioning., Conclusion: Monitoring the FEO 2 is a more reliable way to verify O 2 delivery to an oxygenator. An alarm can be set on the FEO 2 monitor to alert the perfusionist if the FEO 2 falls below a predetermined threshold so any issue with O 2 delivery will always be recognized.

Objective: Evaluate how emotional intelligence (EI) has been measured among surgeons and to investigate interventions implemented for improving EI., Summary Background: EI has relevant applications in surgery given its alignment with nontechnical skills. In recent years, EI has been measured in a surgical context to evaluate its relationship with measures such as surgeon burnout and the surgeon-patient relationship., Methods: A systematic review was conducted by searching MEDLINE, EMBASE, CINAHL, and PSYCINFO databases using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. MeSH terms and keywords included "emotional intelligence," "surgery," and "surgeon." Eligible studies included an EI assessment of surgeons, surgical residents, and/or medical students within a surgical context., Results: The initial search yielded 4627 articles. After duplicate removal, 4435 articles were screened by title and abstract and 49 articles proceeded to a full-text read. Three additional articles were found via hand search. A total of 37 articles were included. Studies varied in surgical specialties, settings, and outcome measurements. Most occurred in general surgery, residency programs, and utilized self-report surveys to estimate EI. Notably, EI improved in all studies utilizing an intervention., Conclusions: The literature entailing the intersection between EI and surgery is diverse but still limited. Generally, EI has been demonstrated to be beneficial in terms of overall well-being and job satisfaction while also protecting against burnout. EI skills may provide a promising modifiable target to achieve desirable outcomes for both the surgeon and the patient. Future studies may emphasize the relevance of EI in the context of surgical teamwork., Competing Interests: The authors report no conflicts of interest., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

The cardiac surgery operating room is a high-risk and complex environment in which multiple experts work as a team to provide safe and excellent care to patients. During the cardiopulmonary bypass phase of cardiac surgery, critical decisions need to be made and the perfusionists play a crucial role in assessing available information and taking a certain course of action. In this paper, we report the findings of a simulation-based study using machine learning to build predictive models of perfusionists' decision-making during critical situations in the operating room (OR). Performing 30-fold cross-validation across 30 random seeds, our machine learning approach was able to achieve an accuracy of 78.2% (95% confidence interval: 77.8% to 78.6%) in predicting perfusionists' actions, having access to only 148 simulations. The findings from this study may inform future development of computerised clinical decision support tools to be embedded into the OR, improving patient safety and surgical outcomes., Competing Interests: Disclosure statement No potential conflict of interest was reported by the author(s).

Objective: This novel preliminary study sought to capture dynamic changes in heart rate variability (HRV) as a proxy for cognitive workload among perfusionists while operating the cardiopulmonary bypass (CPB) pump during real-life cardiac surgery., Background: Estimations of operators' cognitive workload states in naturalistic settings have been derived using noninvasive psychophysiological measures. Effective CPB pump operation by perfusionists is critical in maintaining the patient's homeostasis during open-heart surgery. Investigation into dynamic cognitive workload fluctuations, and their relationship with performance, is lacking in the literature., Method: HRV and self-reported cognitive workload were collected from three Board-certified cardiac perfusionists ( N = 23 cases). Five HRV components were analyzed in consecutive nonoverlapping 1-min windows from skin incision through sternal closure. Cases were annotated according to predetermined phases: prebypass, three phases during bypass, and postbypass. Values from all 1min time windows within each phase were averaged., Results: Cognitive workload was at its highest during the time between initiating bypass and clamping the aorta (preclamp phase during bypass), and decreased over the course of the bypass period., Conclusion: We identified dynamic, temporal fluctuations in HRV among perfusionists during cardiac surgery corresponding to subjective reports of cognitive workload. Not only does cognitive workload differ for perfusionists during bypass compared with pre- and postbypass phases, but differences in HRV were also detected within the three bypass phases., Application: These preliminary findings suggest the preclamp phase of CPB pump interaction corresponds to higher cognitive workload, which may point to an area warranting further exploration using passive measurement.

Objective: The aim of this study was to elucidate the cognitive processes involved in surgical procedures from the perspective of different team roles (surgeon, anesthesiologist, and perfusionist) and provide a comprehensive compilation of intraoperative cognitive processes., Summary Background Data: Nontechnical skills play a crucial role in surgical team performance and understanding the cognitive processes underlying the intraoperative phase of surgery is essential to improve patient safety in the operating room (OR)., Methods: A mixed-methods approach encompassing semistructured interviews with 9 subject-matter experts. A cognitive task analysis was built upon a hierarchical segmentation of coronary artery bypass grafting procedures and a cued-recall protocol using video vignettes was used., Results: A total of 137 unique surgical cognitive processes were identified, including 33 decision points, 23 critical communications, 43 pitfalls, and 38 strategies. Self-report cognitive workload varied substantially, depending on team role and surgical step. A web-based dashboard was developed, providing an integrated visualization of team cognitive processes in the OR that allows readers to intuitively interact with the study findings., Conclusions: This study advances the current body of knowledge by making explicit relevant cognitive processes involved during the intraoperative phase of cardiac surgery from the perspective of multiple OR team members. By displaying the research findings in an interactive dashboard, we provide trainees with new knowledge in an innovative fashion that could be used to enhance learning outcomes. In addition, the approach used in the present study can be used to deeply understand the cognitive factors underlying surgical adverse events and errors in the OR., Competing Interests: The authors report no conflicts of interest., (Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.)

Importance: Randomized clinical trials (RCTs) provide the highest level of evidence to evaluate 2 or more surgical interventions. Surgical RCTs, however, face unique challenges in design and implementation., Objective: To evaluate the design, conduct, and reporting of contemporary surgical RCTs., Evidence Review: A literature search performed in the 2 journals with the highest impact factor in general medicine as well as 6 key surgical specialties was conducted to identify RCTs published between 2008 and 2020. All RCTs describing a surgical intervention in both experimental and control arms were included. The quality of included data was assessed by establishing an a priori protocol containing all the details to extract. Trial characteristics, fragility index, risk of bias (Cochrane Risk of Bias 2 Tool), pragmatism (Pragmatic Explanatory Continuum Indicator Summary 2 [PRECIS-2]), and reporting bias were assessed., Findings: A total of 388 trials were identified. Of them, 242 (62.4%) were registered; discrepancies with the published protocol were identified in 81 (33.5%). Most trials used superiority design (329 [84.8%]), and intention-to-treat as primary analysis (221 [56.9%]) and were designed to detect a large treatment effect (50.0%; interquartile range [IQR], 24.7%-63.3%). Only 123 trials (31.7%) used major clinical events as the primary outcome. Most trials (303 [78.1%]) did not control for surgeon experience; only 17 trials (4.4%) assessed the quality of the intervention. The median sample size was 122 patients (IQR, 70-245 patients). The median follow-up was 24 months (IQR, 12.0-32.0 months). Most trials (211 [54.4%]) had some concern of bias and 91 (23.5%) had high risk of bias. The mean (SD) PRECIS-2 score was 3.52 (0.65) and increased significantly over the study period. Most trials (212 [54.6%]) reported a neutral result; reporting bias was identified in 109 of 211 (51.7%). The median fragility index was 3.0 (IQR, 1.0-6.0). Multiplicity was detected in 175 trials (45.1%), and only 35 (20.0%) adjusted for multiple comparisons., Conclusions and Relevance: In this systematic review, the size of contemporary surgical trials was small and the focus was on minor clinical events. Trial registration remained suboptimal and discrepancies with the published protocol and reporting bias were frequent. Few trials controlled for surgeon experience or assessed the quality of the intervention.

Shared mental models are critical to team success; however, in practice, team members may have misaligned models due to a variety of factors. In safety-critical domains (e.g., aviation, healthcare), lack of shared mental models can lead to preventable errors and harm. Towards the goal of mitigating such preventable errors, here, we present a Bayesian approach to infer misalignment in team members' mental models during complex healthcare task execution. As an exemplary application, we demonstrate our approach using two simulated team-based scenarios, derived from actual teamwork in cardiac surgery. In these simulated experiments, our approach inferred model misalignment with over 75% recall, thereby providing a building block for enabling computer-assisted interventions to augment human cognition in the operating room and improve teamwork.

Surgical time-outs are designed to promote situation awareness, teamwork, and error prevention. The pre-incision time-out in particular aims to facilitate shared mental models prior to incision. Objective, unbiased measures to confirm its effectiveness are lacking. We hypothesized that providers' mental workload would reveal team psychophysiological mirroring during a formal, well-executed pre-incision time-out. Heart rate variability was collected during cardiac surgery cases from the surgeon, anesthesiologist, and perfusionist. Data were analyzed for six cases from patient arrival until sternal closure. Annotation of surgical phases was completed according to previously developed standardized process models of aortic valve replacement and coronary artery bypass graft procedures, producing thirteen total surgical phases. Statistical analysis revealed significant main effects. Tukey HSD post hoc tests revealed significant differences across provider roles within various phases, including Anesthesia Induction, Heparinization, Initiation of Bypass, Aortic Clamp and Cardioplegia, Anastomoses or Aortotomy, Separation from Bypass, and Sternal Closure. Despite these observed differences between providers over various surgical phases, the Pre-incision Time-out phase revealed almost negligible differences across roles. This preliminary work supports the utility of the pre-incision safety checklist to focus the attention of surgical team members and promote shared team mental models, measured via psychophysiological mirroring, using an objective mental workload measure. Future studies should investigate the relationship between psychophysiological mirroring among surgical team members and the effectiveness of the pre-incision time-out checklist.

Objective: Mirrored psychophysiological change in cognitive workload indices may reflect shared mental models and effective healthcare team dynamics. In this exploratory analysis, we investigated the frequency of mirrored changes, defined as concurrent peaks in heart rate variability (HRV) across team members, during cardiac surgery., Design: Objective cognitive workload was evaluated via HRV collected from the primary surgical team during cardiac surgery cases (N = 15). Root mean square of the successive differences (RMSSD) was calculated as the primary HRV measure. Procedures were divided into consecutive nonoverlapping 5-minute segments, and RMSSD along with deviations from RMSSD were calculated for each segment. Segments with positive deflections represent above-average cognitive workload. Positive deflections and peaks across dyads within the same segment were counted., Setting: Data collection for this study took place in the cardiovascular operating room during live surgeries., Participants: Physiological data were collected and analyzed from the attending surgeon, attending anesthesiologist, and primary perfusionist involved with the recorded cases., Results: Of the 641 five-minute segments analyzed, 325 (50.7%) were positive deflections above average, concurrently across at least 2 team members. Within the 325 positive deflections, 26 (8%) represented concurrent peaks in HRV across at least 2 active team members. Mirrored peaks across team members were observed most commonly during the coronary anastomoses or valve replacement phase (N = 12)., Conclusions: In this pilot study, mirrored physiological responses representing peaks in cognitive workload were observed uncommonly across dyads of cardiac surgery team members (1.73 peaks/case on average). Almost half of these occurred during the most technically demanding phases of cardiac surgery, which may underpin teamwork quality. Future work should investigate interactions between technical and nontechnical performance surrounding times of mirrored peaks and expand the sample size., (Copyright © 2020 Association of Program Directors in Surgery. All rights reserved.)

Effectiveness of computer vision techniques has been demonstrated through a number of applications, both within and outside healthcare. The operating room environment specifically is a setting with rich data sources compatible with computational approaches and high potential for direct patient benefit. The aim of this review is to summarize major topics in computer vision for surgical domains. The major capabilities of computer vision are described as an aid to surgical teams to improve performance and contribute to enhanced patient safety. Literature was identified through leading experts in the fields of surgery, computational analysis and modeling in medicine, and computer vision in healthcare. The literature supports the application of computer vision principles to surgery. Potential applications within surgery include operating room vigilance, endoscopic vigilance, and individual and team-wide behavioral analysis. To advance the field, we recommend collecting and publishing carefully annotated datasets. Doing so will enable the surgery community to collectively define well-specified common objectives for automated systems, spur academic research, mobilize industry, and provide benchmarks with which we can track progress. Leveraging computer vision approaches through interdisciplinary collaboration and advanced approaches to data acquisition, modeling, interpretation, and integration promises a powerful impact on patient safety, public health, and financial costs.

Background. The most commonly used subjective assessment of perceived cognitive load, the NASA Task Load Index (TLX), has proven valuable in measuring individual load among general populations. The surgery task load index (SURG-TLX) was developed and validated to measure cognitive load specifically among individuals within a surgical team. Notably, the TLX lacks temporal sensitivity in its typical retrospective administration. Objective. This study sought to expand the utility of SURG-TLX by investigating individual measures of cognitive load over time during cardiac surgery, and the relationship between individual and team measures of cognitive load and proxies for surgical complexity. Materials & Methods. SURG-TLX was administered retrospectively in the operating room immediately following each case to approximate cognitive load before, during, and after cardiopulmonary bypass for cardiac surgery team members (surgeon, anesthesiologist, and perfusionist). Correlations were calculated to determine the relationship of individual and team measures of cognitive load over the entire procedure with bypass length and surgery length. Results. Results suggest that perceived cognitive load varies throughout the procedure such that cognitive load during bypass significantly differs compared to before or after bypass, across all 3 roles. While on bypass, results show that anesthesiologists experience significantly lower levels of perceived cognitive load than both surgeons and perfusionists. Correlational analyses reveal that perceived cognitive load of both the surgeon and the team had significant positive associations with bypass length and surgery length. Conclusion. Our findings support the utility of SURG-TLX in real cardiac cases as a measure of cognitive load over time, and on an individual and team-wide basis.

The tremendous and rapid technological advances that humans have achieved in the last decade have definitely impacted how surgical tasks are performed in the operating room (OR). As a high-tech work environment, the contemporary OR has incorporated novel computational systems into the clinical workflow, aiming to optimize processes and support the surgical team. Artificial intelligence (AI) is increasingly important for surgical decision making to help address diverse sources of information, such as patient risk factors, anatomy, disease natural history, patient values and cost, and assist surgeons and patients to make better predictions regarding the consequences of surgical decisions. In this review, we discuss the current initiatives that are using AI in cardiothoracic surgery and surgical care in general. We also address the future of AI and how high-tech ORs will leverage human-machine teaming to optimize performance and enhance patient safety.

Surgical processes are rapidly being adapted to address the COVID-19 pandemic, with changes in procedures and responsibilities being made to protect both patients and medical teams. These process changes put new cognitive demands on the medical team and increase the likelihood of miscommunication, lapses in judgment, and medical errors. We describe two process model driven cognitive aids, referred to as the Narrative View and the Smart Checklist View, generated automatically from models of the processes. The immediate perceived utility of these cognitive aids is to support medical simulations, particularly when frequent adaptations are needed to quickly respond to changing operating room guidelines.

Cardiac surgery represents a complex sociotechnical environment relying on a combination of technical and non-technical team-based expertise. Surgical flow disruptions (SFDs) may be influenced by a variety of sources, including social, environmental, and emotional factors affecting healthcare providers (HCPs). Many of these factors can be readily observed, except for emotional factors (i.e. distress), which represents an underappreciated yet critical source of SFDs. The aim of this study was to demonstrate the sensitivity of autonomic activity metrics to detect an SFD during cardiac surgery. We integrated heart rate variability (HRV) analysis with observation-based annotations to allow data triangulation. Following a critical medication administration error by the anesthesiologist in-training, data sources were consulted to identify events precipitating this near-miss event. Using pyphysio , an open-source physiological signal processing package, we analyzed the attending anesthesiologists' HRV, specifically the low frequency (LF) power, high frequency (HF) power, LF/HF ratio, standard deviation of normal-to-normal (SDNN), and root mean square of the successive differences (RMSSD) as indicators of ANS activity. A heightened SNS response in the attending anesthesiologists' physiological arousal was observed as elevations in LF power and LF/HF ratio, as well as depressions in HF power, SDNN, and RMSSD prior to the near-miss event. The attending anesthesiologist subjectively confirmed a state of high distress induced by task-irrelevant environmental factors during this time. Qualitative analysis of audio/video recordings objectively revealed that the autonomic nervous system (ANS) activation detected was temporally associated with an argument over operating room management. This study confirms that it is possible to recognize detrimental psychophysiological influences in cardiac surgery procedures via advanced HRV analysis. To our knowledge, ours is the first such case demonstrating ANS activity coinciding with strong self-reported emotion during live surgery using HRV. Despite extensive experience in the cardiac OR, transient but intense emotional changes may have the potential to disrupt attention processes in even the most experienced HCP. A primary implication of this work is the possibility to detect real-time ANS activity, which could enable personalized interventions to proactively mitigate downstream adverse events. Additional studies on our large database of surgical cases are underway and new studies are actively being planned to confirm this preliminary observation.

Cardiac surgery is one of the most complex specialties in medicine, akin to a complex sociotechnical system. Patient outcomes are vulnerable to surgical flow disruptions (SFDs), a source of preventable harm. Healthcare providers' (HCPs) sympathetic activation secondary to emotional states represent an underappreciated source of SFDs. This study's objective was to demonstrate the feasibility of detecting elevated sympathetic nervous system (SNS) activity as a proxy for emotional distress associated with a medication error using heart rate variability (HRV) analysis. After obtaining informed consent, audio/video and HRV data were captured intraoperatively during cardiac surgery from multiple HCPs. Following a critical medication administration error by the anesthesiologist in-training, the attending anesthesiologists' recorded HRV data was analyzed using pyphysio , an open-source signal analysis package, to identify events precipitating this near-miss event. We considered elevated low-frequency/high-frequency (LF/HF) HRV ratio (normal value <2) as a primary indicator of SNS activity and emotional distress. A heightened SNS response by the attending anesthesiologist, observed as an LF/HF ratio value of 3.39, was detected prior to the near-miss event. The attending anesthesiologist confirmed a state of significant SNS activity/distress induced by task-irrelevant environmental factors, which led to a temporarily ineffective mental model. Qualitative analysis of audio/video recordings revealed that SNS activation coincided with an argument over operating room management causing SFD. This preliminary study confirms the feasibility of recognizing potentially detrimental psychophysiological states during cardiac surgery in the wild using HRV analysis. To our knowledge, this is the first case demonstrating SNS activation coinciding with self-reported and observable emotional distress during live surgery using HRV. Irrespective of the HCP's expertise, transient but intense emotional changes may disrupt attention processes leading to SFDs and preventable errors. This work supports the possibility to detect real-time SNS activation, which could enable interventions to proactively mitigate errors. Additional studies on our large database of surgical cases are underway to confirm this observation.

Compared with randomized controlled trials (RCTs) in medical specialties, RCTs in cardiac surgery face specific issues. Individual and collective equipoise, rapid evolution of the surgical techniques, as well as difficulties in obtaining funding, and limited education in clinical epidemiology in the surgical community are among the most important challenges in the design phase of the trial. Use of complex interventions and learning curve effect, differences in individual operators' expertise, difficulties in blinding, and slow recruitment make the successful completion of cardiac surgery RCTs particularly challenging. In fact, over the course of the last 20 years, the number of cardiac surgery RCTs has declined significantly. In this review, a team of surgeons, trialists, and epidemiologists discusses the most important challenges faced by RCTs in cardiac surgery and provides a list of suggestions for the successful design and completion of cardiac surgery RCTs., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Introduction: The complexities and risks inherent to the field of surgery and surgical interventions present unique challenges to the design and analysis of surgical randomized controlled trials (RCT). Prior studies have investigated the practical and methodologic challenges posed by surgical RCTs. To date, however, a comprehensive analysis of the contemporary literature across multiple surgical subspecialties does not exist. In this descriptive analysis, we set out to characterize surgical RCTs over the past 10 years across six major surgical specialties., Methods and Analysis: A literature search by a medical librarian will be performed to identify all surgical randomized clinical trials published between January 2009 and December 2019 in the two journals with the highest impact factor for six surgical specialties as well as two large general medicine journals. Two reviewers will independently screen the citations retrieved from the literature search and extract data according to a previously described protocol via a pre-defined data collection form. Categorical variables will be reported as counts and percentages. Following assessment of normality, continuous variables will be reported as mean (standard deviation) or median (inter-quartile range). Based on normality of data, independent t-test or the Mann-Whitney U test will be used to compare continuous variables and chi-square and Fisher's exact tests to compare categorical variables. Comparisons across multiple sets will be performed using ANOVA or Kruskak-Wallis tests. Two-sided significance testing will be used and a p-value <0.05 will be considered significant without adjustment for multiple testing. All analyses will be performed using SPSS version 24 and R within RStudio. PROSPERO (ID number: 162797)., Ethics and Dissemination: There are no ethical concerns directly pertinent to this systematic review. The retrieved data will be made available upon request. The study will be written in English and submitted for publication in a peer-reviewed journal., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2020 The Authors.)

Objectives: To assess the use of epiaortic ultrasound in contemporary cardiac surgery, as well as its impact on surgical cannulation strategy and cerebrovascular events., Design: Epiaortic ultrasound data was prospectively collected in the Randomized Endovein Graft Prospective (REGROUP) trial (VA Cooperative Studies Program #588, ClinicalTrials.gov, NCT01850082), which randomized 1,150 coronary artery bypass graft patients between 2014 and 2017 to endoscopic or open-vein graft harvest., Setting: Sixteen cardiac surgery programs within the Veterans Affairs Healthcare System with expertise at performing endoscopic vein-graft harvesting., Participants: Veterans Affairs patients, greater than 18 years of age, undergoing elective or urgent coronary artery bypass grafting with cardiopulmonary bypass and cardioplegic arrest with at least one planned saphenous vein graft were eligible for enrollment., Interventions: Epiaortic ultrasound was performed by the surgeon using a high frequency (>7 MHz) ultrasound transducer. Two-dimensional images of the ascending aorta in multiple planes were acquired before aortic cannulation and cross-clamping., Measurements and Main Results: Epiaortic ultrasound was performed in 34.1% (269 of 790) of patients in REGROUP. Among these patients, simple intraluminal atheroma was observed in 21.9% (59 269), and complex intraluminal atheroma comprised 2.2% (6 of 269). The aortic cannulation or cross-clamp strategy was modified based on these findings in 7.1% of cases (19 of 269). There was no difference in stroke between patients who underwent epiaortic ultrasound and those who did not (1.9% v 1.2% p = 0.523)., Conclusions: Despite current guidelines recommending routine use of epiaortic ultrasound (IIa/B) to reduce the risk of stroke in cardiac surgery, in this contemporary trial, use remains infrequent, with significant site-to-site variability., (Published by Elsevier Inc.)