Faculty Bibliography

OBJECTIVES:To compare the efficacy and safety of algenpantucel-L [HyperAcute-Pancreas algenpantucel-L (HAPa); IND# 12311] immunotherapy combined with standard of care (SOC) chemotherapy and chemoradiation to SOC chemotherapy and chemoradiation therapy alone in patients with borderline resectable or locally advanced pancreatic ductal adenocarcinoma (PDAC). SUMMARY BACKGROUND DATA:To date, immunotherapy has not been shown to benefit patients with borderline resectable or locally advanced unresectable PDAC. HAPa is a cancer vaccine consisting of allogeneic pancreatic cancer cells engineered to express the murine α(1,3)GT gene. METHODS:A multicenter, phase 3, open label, randomized (1:1) trial of patients with borderline resectable or locally advanced unresectable PDAC. Patients received neoadjuvant SOC chemotherapy (FOLFIRINOX or gemcitabine/nab-paclitaxel) followed by chemoradiation (standard group) or the same standard neoadjuvant regimen combined with HAPa immunotherapy (experimental group). The primary outcome was overall survival. RESULTS:Between May 2013 and December 2015, 303 patients were randomized from 32 sites. Median (interquartile range) overall survival was 14.9 (12.2-17.8) months in the standard group (N = 158) and 14.3 (12.6-16.3) months in the experimental group (N = 145) [hazard ratio (HR) 1.02, 95% confidence intervals 0.66-1.58; P = 0.98]. Median progression-free survival was 13.4 months in the standard group and 12.4 months in the experimental group (HR 1.33, 95% confidence intervals 0.72-1.78; P = 0.59). Grade 3 or higher adverse events occurred in 105 of 140 patients (75%) in the standard group and in 115 of 142 patients (81%) in the experimental group (P > 0.05). CONCLUSIONS:Algenpantucel-L immunotherapy did not improve survival in patients with borderline resectable or locally advanced unresectable PDAC receiving SOC neoadjuvant chemotherapy and chemoradiation. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT01836432.

INTRODUCTION:Intrahepatic cholangiocarcinoma (ICC) incidence continues to rise worldwide, and overall survival remains poor. Complete surgical resection remains the only opportunity for cure in patients with ICC yet only one-third of patients present with resectable disease. AREAS COVERED:While the low incidence rate of ICC hinders accrual of patients to large, randomized control trials, larger database and long-term institutional studies provide evidence to guide surgical management of ICC. These studies demonstrate feasibility, safety, and efficacy of aggressive surgical management in appropriately selected patients with ICC. Recent advances in the management of ICC, with a focus on surgical considerations, are reviewed. EXPERT OPINION:Historically, little progress has been made in the management of ICC with stagnant mortality rates and poor long-term outcomes. However, regionalization of care to centers with experienced multidisciplinary teams, advances in minimally invasive surgical techniques, discovery and development of targeted and immunotherapy agents, and combination locoregional and systemic therapies offer signs of progress in the management of ICC.

OBJECTIVES:Evaluate the frequency of self-reported, post-call hazardous driving events in a national cohort of general surgery residents and determine the associations between duty hour policy violations, psychiatric well-being, and hazardous driving events. SUMMARY OF BACKGROUND DATA:MVCs are a leading cause of resident mortality. Extended work shifts and poor psychiatric well-being are risk factors for MVCs, placing general surgery residents at risk. METHODS:General surgery residents from US programs were surveyed after the 2017 American Board of Surgery In-Training Examination. Outcomes included self-reported nodding off while driving, near-miss MVCs, and MVCs. Group-adjusted cluster Chi-square and hierarchical regression models with program-level intercepts measured associations between resident- and program-level factors and outcomes. RESULTS:Among 7391 general surgery residents from 260 programs (response rate 99.3%), 34.7% reported nodding off while driving, 26.6% a near-miss MVC, and 5.0% an MVC over the preceding 6 months. More frequent 80-hour rule violations were associated with all hazardous driving events: nodding off while driving {59.8% with ≥5 months with violations vs 27.2% with 0, adjusted odds ratio (AOR) 2.86 [95% confidence interval (CI) 2.21-3.69]}, near-miss MVCs, [53.6% vs 19.2%, AOR 3.28 (95% CI 2.53-4.24)], and MVCs [14.0% vs 3.5%, AOR 2.46 (95% CI 1.65-3.67)]. Similarly, poor psychiatric well-being was associated with all 3 outcomes [eg, 8.0% with poor psychiatric well-being reported MVCs vs 2.6% without, odds ratio 2.55 (95% CI 2.00-3.24)]. CONCLUSIONS:Hazardous driving events are prevalent among general surgery residents and associated with frequent duty hour violations and poor psychiatric well-being. Greater adherence to duty hour standards and efforts to improve well-being may improve driving safety.

OBJECTIVE:Although well-established metrics exist to measure workplace burnout, researchers disagree about how to categorize individuals based on assessed symptoms. Using a person-centered approach, this study identifies classes of burnout symptomatology in a large sample of general surgery residents in the United States. DESIGN, SETTING, PARTICIPANTS:A survey was administered following the 2018 American Board of Surgery In-Training Examination (ABSITE) to study wellness among U.S. general surgery residents. Latent class models identified distinct classes of residents based on their responses to the emotional exhaustion and depersonalization questions of the modified abbreviated Maslach Burnout Inventory (aMBI). Classes were assigned representative names, and the characteristics of their members and residency programs were compared. RESULTS:The survey was completed by 7415 surgery residents from 263 residency programs nationwide (99.3% response rate). Five burnout classes were found: Burned Out (unfavorable score on all six items, 9.8% of total), Fully Engaged (favorable score on all six items, 23.1%), Fatigued (favorable on all items except frequent fatigue, 32.2%), Overextended (frequent fatigue and burnout from work, 16.7%), and Disengaged (weekly symptoms of fatigue and callousness, 18.1%). Within the more symptomatic classes (Burned Out, Overextended, and Disengaged), men manifested more depersonalization symptoms, whereas women reported more emotional exhaustion symptoms. Burned Out residents were characterized by reports of mistreatment (abuse, sexual harassment, and gender-, racial-, or pregnancy and/or childcare-based discrimination), duty hour violations, dissatisfaction with duty hour regulations or time for rest, and low ABSITE scores. CONCLUSIONS:Burnout is multifaceted, with complex and variable presentations. Latent class modeling categorizes general surgery residents based on their burnout symptomatology. Organizations should tailor their efforts to address the unique manifestations of each class as well as shared drivers.

Importance:Grit, defined as perseverance and passion for long-term goals, is predictive of success and performance even among high-achieving individuals. Previous studies examining the effect of grit on attrition and wellness during surgical residency are limited by low response rates or single-institution analyses. Objectives:To characterize grit among US general surgery residents and examine the association between resident grit and wellness outcomes. Design, Setting, and Participants:A cross-sectional national survey study of 7464 clinically active general surgery residents in the US was administered in conjunction with the 2018 American Board of Surgery In-Training Examination and assessed grit, burnout, thoughts of attrition, and suicidal thoughts during the previous year. Multivariable logistic regression models were constructed to assess the association of grit with resident burnout, thoughts of attrition, and suicidal thoughts. Statistical analyses were performed from June 1 to August 15, 2019. Exposures:Grit was measured using the 8-item Short Grit Scale (scores range from 1 [not at all gritty] to 5 [extremely gritty]). Main Outcomes and Measures:The primary outcome was burnout. Secondary outcomes were thoughts of attrition and suicidal thoughts within the past year. Results:Among 7464 residents (7413 [99.3%] responded; 4469 men [60.2%]) from 262 general surgery residency programs, individual grit scores ranged from 1.13 to 5.00 points (mean [SD], 3.69 [0.58] points). Mean (SD) grit scores were significantly higher in women (3.72 [0.56] points), in residents in postgraduate training year 4 or 5 (3.72 [0.58] points), and in residents who were married (3.72 [0.57] points; all P ≤ .001), although the absolute magnitude of the differences was small. In adjusted analyses, residents with higher grit scores were significantly less likely to report duty hour violations (odds ratio [OR], 0.85; 95% CI, 0.77-0.93), dissatisfaction with becoming a surgeon (OR, 0.53; 95% CI, 0.48-0.59), burnout (OR, 0.53; 95% CI, 0.49-0.58), thoughts of attrition (OR, 0.61; 95% CI, 0.55-0.67), and suicidal thoughts (OR, 0.58; 95% CI, 0.47-0.71). Grit scores were not associated with American Board of Surgery In-Training Examination performance. For individual residency programs, mean program-level grit scores ranged from 3.18 to 4.09 points (mean [SD], 3.69 [0.13] points). Conclusions and Relevance:In this national survey evaluation, higher grit scores were associated with a lower likelihood of burnout, thoughts of attrition, and suicidal thoughts among general surgery residents. Given that surgical resident grit scores are generally high and much remains unknown about how to employ grit measurement, grit is likely not an effective screening instrument to select residents; instead, institutions should ensure an organizational culture that promotes and supports trainees across this elevated range of grit scores.

OBJECTIVES:The aims of this study were to: (1) measure the prevalence of self-reported medical error among general surgery trainees, (2) assess the association between general surgery resident wellness (ie, burnout and poor psychiatric well-being) and self-reported medical error, and (3) examine the association between program-level wellness and objectively measured patient outcomes. SUMMARY OF BACKGROUND DATA:Poor wellness is prevalent among surgical trainees but the impact on medical error and objective patient outcomes (eg, morbidity or mortality) is unclear as existing studies are limited to physician and patient self-report of events and errors, small cohorts, or examine few outcomes. METHODS:A cross-sectional survey was administered immediately following the January 2017 American Board of Surgery In-training Examination to clinically active general surgery residents to assess resident wellness and self-reported error. Postoperative patient outcomes were ascertained using a validated national clinical data registry. Associations were examined using multivariable logistic regression models. RESULTS:Over a 6-month period, 22.5% of residents reported committing a near miss medical error, and 6.9% reported committing a harmful medical error. Residents were more likely to report a harmful medical error if they reported frequent burnout symptoms [odds ratio 2.71 (95% confidence interval 2.16-3.41)] or poor psychiatric well-being [odds ratio 2.36 (95% confidence interval 1.92-2.90)]. However, there were no significant associations between program-level resident wellness and any of the independently, objectively measured postoperative American College of Surgeons National Surgical Quality improvement Program outcomes examined. CONCLUSIONS:Although surgical residents with poor wellness were more likely to self-report a harmful medical error, there was not a higher rate of objectively reported outcomes for surgical patients treated at hospitals with higher rates of burnout or poor psychiatric well-being.