Fc-engineered antibody therapeutics with improved anti-SARS-CoV-2 efficacy.

Monoclonal antibodies with neutralizing activity against SARS-CoV-2 have demonstrated clinical benefits in cases of mild-to-moderate SARS-CoV-2 infection, substantially reducing the risk for hospitalization and severe disease1-4. Treatment generally requires the administration of high doses of these monoclonal antibodies and has limited efficacy in preventing disease complications or mortality among hospitalized patients with COVID-195. Here we report the development and evaluation of anti-SARS-CoV-2 monoclonal antibodies with optimized Fc domains that show superior potency for prevention or treatment of COVID-19. Using several animal disease models of COVID-196,7, we demonstrate that selective engagement of activating Fcγ receptors results in improved efficacy in both preventing and treating disease-induced weight loss and mortality, significantly reducing the dose required to confer full protection against SARS-CoV-2 challenge and for treatment of pre-infected animals. Our results highlight the importance of Fcγ receptor pathways in driving antibody-mediated antiviral immunity and exclude the possibility of pathogenic or disease-enhancing effects of Fcγ receptor engagement of anti-SARS-CoV-2 antibodies upon infection. These findings have important implications for the development of Fc-engineered monoclonal antibodies with optimal Fc-effector function and improved clinical efficacy against COVID-19 disease.

How Does the Sequence of the American Board of Surgery Examinations Impact Pass/Fail Outcomes?

OBJECTIVE: Historically, the American Board of Surgery required surgeons to pass the qualifying examination (QE) before taking the certifying examination (CE). However, in the 2020-2021 academic year, with mitigating circumstances related to COVID-19, the ABS removed this sequencing requirement to facilitate the certification process for those candidates who were negatively impacted by a QE delivery failure. This decoupling of the traditional order of exam delivery has provided a natural comparator to the traditional route and an analysis of the impact of examination sequencing on candidate performance. METHODS: All candidates who applied for the canceled July 2020 QE were allowed to take the CE before passing the QE. The sample was then reduced to include only first-time candidates to ensure comparable groups for performance outcomes. Logistic regression was used to analyze the relationship between the order of taking the QE and the CE, controlling for other examination performance, international medical graduate status, and gender. RESULTS: Only first-time candidates who took both examinations were compared (n=947). Examination sequence was not a significant predictor of QE pass/fail outcomes, OR=0.54; 95% CI, 0.19-1.61, P =0.26. However, examination sequence was a significant predictor of CE pass/fail outcomes, OR=2.54; 95% CI, 1.46-4.68, P =0.002. CONCLUSIONS: This important study suggests that preparation for the QE increases the probability of passing the CE and provides evidence that knowledge may be foundational for clinical judgment. The ABS will consider these findings for examination sequencing moving forward.

Are General Surgery Residencies Preparing Graduates for the Practice of Today's General Surgeon? An Analysis of American Board of Surgery Data From Applicants and Re-certifying Surgeons.

OBJECTIVE: To compare the operative experience of general surgery residents and practicing general surgeons. SUMMARY OF BACKGROUND DATA: The scope of general surgery has evolved, yet it remains unknown whether residents are being exposed to the right mix of operations during residency. METHODS: A retrospective review of operative case logs submitted to the American Board of Surgery by US general surgery graduates and practicing general surgeons from 2013 to 2017 was performed. The operative experience of both cohorts was calculated as a proportion of total experience and ranked by frequency. The proportional experience between cohorts was analyzed using factorial analysis of variance. RESULTS: During the 5-year period, 5482 graduates applied for initial American Board of Surgery certification, and 4152 diplomates applied for recertification. Among all operative domains, the graduate experience was similar to that of diplomates in 6 of 12 areas (abdomen, alimentary tract, endoscopy, endocrine, other, skin/soft tissue; all P > 0.05). Residents have a greater experience in subspecialty areas (pediatric, thoracic, trauma, vascular, and plastic) at the expense of fewer breast procedures (all P < 0.05). The 30 operations most commonly performed by graduates comprised 67% of their total operative experience. Among these, residents performed 25 cases ≥10 times, 14 cases ≥20 times, and 7 cases ≥40 times. CONCLUSIONS: The operative experience of graduating US general surgery residents is largely similar to that of practicing general surgeons, particularly for core general surgery domains. These data offer reassurance that surgical training in the modern era appropriately exposes residents to the operations they may perform in practice.

Association Between American Board of Surgery Initial Certification and Medical Malpractice Payments.

OBJECTIVE: To measure associations between surgeons' examination performance and obtaining American Board of Surgery certification with the likelihood of having medical malpractice payments. BACKGROUND: Further research is needed to establish a broader understanding of the association of board certification and patient and practice outcomes. METHODS: Retrospective analysis using propensity score-matched surgeons who attempted to obtain American Board of Surgery certification. Surgeons who completed residency between 2000 and 2019 (n=910) and attempted to become certified were categorized as certified or failing to obtain certification. In addition, groups were categorized as either passing or failing their first attempt on the qualifying and certifying examinations. Malpractice payment reports were dichotomized for surgeons who either had a payment report or not. RESULTS: The hazard rate (HR) of malpractice payment reports was significantly greater for surgeons who attempted and failed to obtain certification [HR=1.87; 95% confidence interval (CI), 1.28-2.74] than for surgeons who were certified. Moreover, surgeons who failed either the qualifying (HR=1.64; 95% CI, 1.14-2.37) or certifying examination (HR=1.72; 95% CI, 1.14-2.60) had significantly higher malpractice payment HRs than those who passed the examinations on their first attempt. CONCLUSIONS: Failing to obtain board certification was associated with a higher rate of medical malpractice payments. In addition, failing examinations in the certification examination process on the first attempt was also associated with higher rates of medical malpractice payments. This study provides further evidence that board certification is linked to potential indicators for patient outcomes and practice quality.

Surgical Trainee Performance and Alignment With Surgical Program Director Expectations.

OBJECTIVE: To examine the alignment between graduating surgical trainee operative performance and a prior survey of surgical program director expectations. BACKGROUND: Surgical trainee operative training is expected to prepare residents to independently perform clinically important surgical procedures. METHODS: We conducted a cross-sectional observational study of US general surgery residents' rated operative performance for Core general surgery procedures. Residents' expected performance on those procedures at the time of graduation was compared to the current list of Core general surgery procedures ranked by their importance for clinical practice, as assessed via a previous national survey of general surgery program directors. We also examined the frequency of individual procedures logged by residents over the course of their training. RESULTS: Operative performance ratings for 29,885 procedures performed by 1861 surgical residents in 54 general surgery programs were analyzed. For each Core general surgery procedure, adjusted mean probability of a graduating resident being deemed practice-ready ranged from 0.59 to 0.99 (mean 0.90, standard deviation 0.08). There was weak correlation between the readiness of trainees to independently perform a procedure at the time of graduation and that procedure's historical importance to clinical practice ( p = 0.22, 95% confidence interval 0.01-0.41, P = 0.06). Residents also continue to have limited opportunities to learn many procedures that are important for clinical practice. CONCLUSION: The operative performance of graduating general surgery residents may not be well aligned with surgical program director expectations.

Implementation of the Vascular Surgery Board virtual certifying examination.

OBJECTIVE: The onset of the COVID-19 (coronavirus disease 2019) pandemic mandated postponement of the in-person Vascular Surgery Board 2020 certifying examination (CE). Vascular surgery virtual CEs (VVCEs) were developed for the scheduled 2020 CEs (rescheduled to January 2021) and 2021 CEs (rescheduled to July 2021) to avoid postponing the certification testing. In the present study, we have reported the development, implementation, and outcomes of the first two VVCEs. METHODS: The VVCE was similar to the in-person format (three 30-minutes sessions, two examiners, four questions) but required a proctor and a host. In contrast to the general surgery VCEs, the VVCE also incorporated images. The candidates and examiners were instructed on the format, and technology checks were performed before the VVCE. The candidates were given the opportunity to invalidate their examination for technology-related reasons immediately after the examination. Postexamination surveys were administered to all the participants. RESULTS: The VVCEs were completed by 356 of 357 candidates (99.7%). The pass rates for the January 2021 and July 2021 examinations were 97.6% (first time, 99.4%; retake, 70%) and 94.7% (first time, 94.6%; retake, 100%), respectively. The pass rates were not significantly different from the 2019 in-person CE (χ2 = 2.30; P = .13; and χ2 = 0.01; P = .91, for the January 2021 and July 2021 examinations, respectively). None of the candidates had invalidated their examination. The candidates (162 of 356; 46%), examiners (64 of 118; 54%), proctors (25 of 27; 93%), and hosts (8 of 9; 89%) completing the survey were very satisfied with the examination (Likert score 4 or 5: candidates, 92.6%; noncandidates, 96.9%) and found the technology domains (Zoom, audio, video, viewing images) to be very good (Likert score 4 or 5), with candidate and other responder scores of 73% to 84% and >94%, respectively. Significantly more of the candidates had favored a future VVCE compared with the examiners (87% vs 32%; χ2 = 67.1; P < .001). The free text responses from all responders had commented favorably on the organization and implementation of the examination. However, some candidates had expressed concerns about image sizes, and some examiners had expressed concern about the time constraints for the question format. The candidates appreciated the convenience of an at-home examination, especially the avoidance of travel costs. CONCLUSIONS: The two Vascular Surgery Board VCEs were shown to be psychometrically sound and were overwhelmingly successful, demonstrating that image-based virtual examinations are feasible and could become the standard for the future.

The vascular surgery in-training examination predicts performance on qualifying examination.

OBJECTIVE: Vascular surgery trainees participate in the vascular surgery in-training examination (VSITE) during each year of their training. Although the VSITE was developed as a low-stakes, formative examination, performance on that examination might correlate with the pass rates for the Vascular Surgery Board written qualifying examination (VQE) and oral certifying examination (VCE) and might, therefore, guide both trainees and program directors. The present study was designed to examine the ability of the VSITE to predict trainees' performance on the VQE and VCE. METHODS: All first-time candidates of the Vascular Surgery Board VQE and VCE were analyzed from 2016 to 2020, including those from both the integrated and independent training pathways. VSITE scores from the final year of training were associated with the VQE scores and the probability of passing the VQE and VCE both. Linear and logistic regression models were used to determine the ability of VSITE results to predict the VQE scores and the probability of passing each board examination. RESULTS: VSITE scores available for the 559 candidates (69.3% male; 30.7% female) who had completed the VQE and 369 candidates (66.7% male; 33.3% female) who had completed both the VQE and the VCE. The linear regression model results for the final year of training showed that the VSITE scores explained 34% of the variance in the VQE scores (29% for the integrated and 37% for the independent trainees). Logistic regression demonstrated that the final year VSITE scores were a significant predictor of passing the VQE for both integrated and independent trainees (P < .001). A VSITE score of 500 during the final year of training predicted a VQE passing probability of >90% for each group of candidates. The probability of passing the VQE decreased to 73% for candidates from integrated programs, 61% for candidates from independent programs, and 64% for the whole cohort when the score was 400. The VSITE scores were a significant predictor of passing the VCE only for the candidates from independent programs (odds ratio, 1.01; 95% confidence interval, 1.00-1.02; P < .01), for whom a VSITE score of 400 correlated with an 82% probability of passing the VCE. CONCLUSIONS: VSITE performance is predictive of passing the VQE for trainees from both integrated and independent training paradigms. Vascular surgery trainees and training programs should optimize their preparation and educational efforts to maximize performance on the VSITE during their final year of training to improve the likelihood of passing the VQE. Further analysis of the predictive value of VSITE scores during the earlier years of training might allow the board certification examinations to be administered earlier in the final year of training.

Outcomes of the First Virtual General Surgery Certifying Exam of the American Board of Surgery.

OBJECTIVE: To Study the Outcomes of the First Virtual General Surgery Certifying Exam of the American Board of Surgery. SUMMARY OF BACKGROUND DATA: The ABS General Surgery CE is normally an in-person oral examination. Due to the COVID-19 outbreak, the ABS was required to reschedule these. After 2 small pilots, the CE's October administration represented the first large-scale remote virtual exam. The purpose of this report is to compare the outcomes of this virtual and the previous in-person CEs. METHODS: CE candidates were asked to provide feedback on their experience via a survey. The passing rate was compared to the 1025 candidates who took the 2019-2020 in-person CEs. RESULTS: Of the 308 candidates who registered for the virtual CE, 306 completed the exam (99.4%) and 188 completed the survey (61.4%). The majority had a very positive experience. They rated the virtual CE as very good/excellent in security (90%), ease of exam platform (77%), audio quality (71%), video quality (69%), and overall satisfaction (86%). Notably, when asked their preference, 78% preferred the virtual exam. There were no differences in the passing rates between the virtual or in-person exams. CONCLUSIONS: The first virtual CE by the ABS was completed using available internet technology. There was high satisfaction, with the majority preferring the virtual platform. Compared to past in-person CEs, there was no difference in outcomes as measured by passing rates. These data suggest that expansion of the virtual CE may be desirable.

Is Initial Board Certification Associated With Better Early Career Surgical Outcomes?

OBJECTIVE: To determine if initial American Board of Surgery certification in general surgery is associated with better risk-adjusted patient outcomes for Medicare patients undergoing partial colectomy by an early career surgeon. BACKGROUND: Board certification is a voluntary commitment to professionalism, continued learning, and delivery of high-quality patient care. Not all surgeons are certified, and some have questioned the value of certification due to limited evidence that board-certified surgeons have better patient outcomes. In response, we examined the outcomes of certified versus noncertified early career general surgeons. METHODS: We identified Medicare patients who underwent a partial colectomy between 2008 and 2016 and were operated on by a non-subspecialty trained surgeon within their first 5 years of practice. Surgeon certification status was determined using the American Board of Surgery data. Generalized linear mixed models were used to control for patient-, procedure-, and hospital-level effects. Primary outcomes were the occurrence of severe complications and occurrence of death within 30 days. RESULTS: We identified 69,325 patients who underwent a partial colectomy by an early career general surgeon. The adjusted rate of severe complications after partial colectomy by certified (n = 4239) versus noncertified (n = 191) early-career general surgeons was 9.1% versus 10.7% (odds ratio 0.83, P = 0.03). Adjusted mortality rate for certified versus noncertified early-career general surgeons was 4.9% versus 6.1% (odds ratio 0.79, P = 0.01). CONCLUSION: Patients undergoing partial colectomy by an early career general surgeon have decreased odds of severe complications and death when their surgeon is board certified.

Increased time from physiological derangement to critical care admission associates with mortality.

BACKGROUND: Rapid response systems aim to achieve a timely response to the deteriorating patient; however, the existing literature varies on whether timing of escalation directly affects patient outcomes. Prior studies have been limited to using 'decision to admit' to critical care, or arrival in the emergency department as 'time zero', rather than the onset of physiological deterioration. The aim of this study is to establish if duration of abnormal physiology prior to critical care admission ['Score to Door' (STD) time] impacts on patient outcomes. METHODS: A retrospective cross-sectional analysis of data from pooled electronic medical records from a multi-site academic hospital was performed. All unplanned adult admissions to critical care from the ward with persistent physiological derangement [defined as sustained high National Early Warning Score (NEWS) > / = 7 that did not decrease below 5] were eligible for inclusion. The primary outcome was critical care mortality. Secondary outcomes were length of critical care admission and hospital mortality. The impact of STD time was adjusted for patient factors (demographics, sickness severity, frailty, and co-morbidity) and logistic factors (timing of high NEWS, and out of hours status) utilising logistic and linear regression models. RESULTS: Six hundred and thirty-two patients were included over the 4-year study period, 16.3% died in critical care. STD time demonstrated a small but significant association with critical care mortality [adjusted odds ratio of 1.02 (95% CI 1.0-1.04, p = 0.01)]. It was also associated with hospital mortality (adjusted OR 1.02, 95% CI 1.0-1.04, p = 0.026), and critical care length of stay. Each hour from onset of physiological derangement increased critical care length of stay by 1.2%. STD time was influenced by the initial NEWS, but not by logistic factors such as out-of-hours status, or pre-existing patient factors such as co-morbidity or frailty. CONCLUSION: In a strictly defined population of high NEWS patients, the time from onset of sustained physiological derangement to critical care admission was associated with increased critical care and hospital mortality. If corroborated in further studies, this cohort definition could be utilised alongside the 'Score to Door' concept as a clinical indicator within rapid response systems.

Recertification Exam Performance in General Surgery is Associated With Subsequent Loss of License Actions.

OBJECTIVES: To measure associations between first-time performance on the American Board of Surgery (ABS) recertification exam with subsequent state medical licensing board disciplinary actions. BACKGROUND: Time-limited board certification has been criticized as unnecessary. Few studies have examined the relationship between recertification exam performance and outcomes. METHODS: Retrospective analysis of loss-of-license action rates for general surgeons who were initially certified by the ABS from 1976 to 2005 and attempted to take a surgery recertification exam. Disciplinary actions from 1976 to 2016 were obtained from the Disciplinary Action Notification System through the American Board of Medical Specialties. RESULTS: A total of 14,169 general surgeons attempted to pass the surgery recertification exam. The rate of loss-of-license actions was significantly higher for surgeons who failed their first exam attempt [incidence rate 3.41, 95% confidence interval (CI) 2.27-4.56] than those who passed on their first attempt (incidence rate .01, 95% CI 0.87-1.14). A Cox proportional-hazards regression model found that the adjusted hazard rate for loss-of-license actions for surgeons who failed their first recertification exam were significantly higher than those who passed their first attempt after adjusting for multiple surgeon characteristics (adjusted hazard rate 2.98, 95% CI 1.85-4.81). CONCLUSIONS: Failing the first recertification exam attempt was associated with a greater rate of subsequent loss-of-license actions. These results suggest that demonstrating sufficient surgical knowledge is a significant predictor of future loss-of-license actions.

A Trimeric HIV-1 Envelope gp120 Immunogen Induces Potent and Broad Anti-V1V2 Loop Antibodies against HIV-1 in Rabbits and Rhesus Macaques.

Trimeric HIV-1 envelope (Env) immunogens are attractive due to their ability to display quaternary epitopes targeted by broadly neutralizing antibodies (bNAbs) while obscuring unfavorable epitopes. Results from the RV144 trial highlighted the importance of vaccine-induced HIV-1 Env V1V2-directed antibodies, with key regions of the V2 loop as targets for vaccine-mediated protection. We recently reported that a trimeric JRFL-gp120 immunogen, generated by inserting an N-terminal trimerization domain in the V1 loop region of a cyclically permuted gp120 (cycP-gp120), induces neutralizing activity against multiple tier-2 HIV-1 isolates in guinea pigs in a DNA prime/protein boost approach. Here, we tested the immunogenicity of cycP-gp120 in a protein prime/boost approach in rabbits and as a booster immunization to DNA/modified vaccinia Ankara (MVA)-vaccinated rabbits and rhesus macaques. In rabbits, two cycP-gp120 protein immunizations induced 100-fold higher titers of high-avidity gp120-specific IgG than two gp120 immunizations, with four total gp120 immunizations being required to induce comparable titers. cycP-gp120 also induced markedly enhanced neutralizing activity against tier-1A and -1B HIV-1 isolates, substantially higher binding and breadth to gp70-V1V2 scaffolds derived from a multiclade panel of global HIV-1 isolates, and antibodies targeting key regions of the V2-loop region associated with reduced risk of infection in RV144. Similarly, boosting MVA- or DNA/MVA-primed rabbits or rhesus macaques with cycP-gp120 showed a robust expansion of gp70-V1V2-specific IgG, neutralization breadth to tier-1B HIV-1 isolates, and antibody-dependent cellular cytotoxicity activity. These results demonstrate that cycP-gp120 serves as a robust HIV Env immunogen that induces broad anti-V1V2 antibodies and promotes neutralization breadth against HIV-1.IMPORTANCE Recent focus in HIV-1 vaccine development has been the design of trimeric HIV-1 Env immunogens that closely resemble native HIV-1 Env, with a major goal being the induction of bNAbs. While the generation of bNAbs is considered a gold standard in vaccine-induced antibody responses, results from the RV144 trial showed that nonneutralizing antibodies directed toward the V1V2 loop of HIV-1 gp120, specifically the V2 loop region, were associated with decreased risk of infection, demonstrating the need for the development of Env immunogens that induce a broad anti-V1V2 antibody response. In this study, we show that a novel trimeric gp120 protein, cycP-gp120, generates high titers of high-avidity and broadly cross-reactive anti-V1V2 antibodies, a result not found in animals immunized with monomeric gp120. These results reveal the potential of cycP-gp120 as a vaccine candidate to induce antibodies associated with reduced risk of HIV-1 infection in humans.

Sweepstakes reproductive success is absent in a New Zealand snapper (Chrysophrus auratus) population protected from fishing despite "tiny" Ne /N ratios elsewhere.

A landmark study published in 2002 estimated a very small Ne /N ratio (around 10-5 ) in a population of pink snapper (Chrysophrys auratus, Forster, 1801) in the Hauraki Gulf in New Zealand. It epitomized the tiny Ne /N ratios (<10-3 ) reported in marine species due to the hypothesized operation of sweepstakes reproductive success (SRS). Here we re-evaluate the occurrence of SRS in marine species and the potential effect of fishing on the Ne /N ratio by studying the same species in the same region, but in a population that has been protected from fishing since 1975. We combine empirical, simulation and model-based approaches to estimate Ne (and Nb ) from genotypes of 1,044 adult fish and estimate N using recapture-probabilities. The estimated Ne /N ratio was much larger (0.33, SE: 0.14) than expected. The magnitude of estimates of population-wide variance in individual lifetime reproductive success (10-18) suggested that the sweepstakes effect was negligible in the study population. After evaluating factors that could explain the contrast between studies - experimental design, life history differences, environmental effects and the influence of exploitation on the Ne /N ratio - we conclude that the low Ne of the Hauraki Gulf population is associated with demographic instability in the harvested compared to the protected population despite circumstantial evidence that the 2002 study may have underestimated Ne . This study has broad implications for the prevailing view that reproductive success in the sea is largely driven by chance, and for genetic monitoring of populations using the Ne /N ratio and Nb .

Is There Gender Bias on the American Board of Surgery General Surgery Certifying Examination?

BACKGROUND: When oral examinations are administered, examiner subjectivity may possibly affect ratings, particularly when examiner severity is influenced by examinee characteristics (e.g., gender) that are independent of examinee ability. This study explored whether the ratings of the general surgery oral certifying examination (CE) of the American Board of Surgery and likelihood of passing the CE were influenced by the gender of examinees or examiners. MATERIALS AND METHODS: Data collected from examinees who attempted the general surgery CE in the 2016-2017 academic year were analyzed. There were 1341 examinees (61% male) and 216 examiners (82% male). Factorial analysis of variance and logistic regression analyses were used to evaluate the effect of examinee and examiner gender on CE ratings and likelihood of passing the CE. RESULTS: Examinees received similar ratings and had similar likelihood of passing the CE regardless of examinee or examiner genders and different combinations of examiner gender pairs (all P values > 0.05). CONCLUSIONS: These results indicate that CE ratings of examinees are not influenced by examinee or examiner gender. There was no evidence of examiner bias due to gender on the CE.

Association of the 2011 ACGME resident duty hour reform with general surgery patient outcomes and with resident examination performance.

IMPORTANCE: In 2011, the Accreditation Council for Graduate Medical Education (ACGME) restricted resident duty hour requirements beyond those established in 2003, leading to concerns about the effects on patient care and resident training. OBJECTIVE: To determine if the 2011 ACGME duty hour reform was associated with a change in general surgery patient outcomes or in resident examination performance. DESIGN, SETTING, AND PARTICIPANTS: Quasi-experimental study of general surgery patient outcomes 2 years before (academic years 2009-2010) and after (academic years 2012-2013) the 2011 duty hour reform. Teaching and nonteaching hospitals were compared using a difference-in-differences approach adjusted for procedural mix, patient comorbidities, and time trends. Teaching hospitals were defined based on the proportion of cases at which residents were present intraoperatively. Patients were those undergoing surgery at hospitals participating in the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP). General surgery resident performance on the annual in-training, written board, and oral board examinations was assessed for this same period. EXPOSURES: National implementation of revised resident duty hour requirements on July 1, 2011, in all ACGME accredited residency programs. MAIN OUTCOMES AND MEASURES: Primary outcome was a composite of death or serious morbidity; secondary outcomes were other postoperative complications and resident examination performance. RESULTS: In the main analysis, 204,641 patients were identified from 23 teaching (n = 102,525) and 31 nonteaching (n = 102,116) hospitals. The unadjusted rate of death or serious morbidity improved during the study period in both teaching (11.6% [95% CI, 11.3%-12.0%] to 9.4% [95% CI, 9.1%-9.8%], P < .001) and nonteaching hospitals (8.7% [95% CI, 8.3%-9.0%] to 7.1% [95% CI, 6.8%-7.5%], P < .001). In adjusted analyses, the 2011 ACGME duty hour reform was not associated with a significant change in death or serious morbidity in either postreform year 1 (OR, 1.12; 95% CI, 0.98-1.28) or postreform year 2 (OR, 1.00; 95% CI, 0.86-1.17) or when both postreform years were combined (OR, 1.06; 95% CI, 0.93-1.20). There was no association between duty hour reform and any other postoperative adverse outcome. Mean (SD) in-training examination scores did not significantly change from 2010 to 2013 for first-year residents (499.7 [ 85.2] to 500.5 [84.2], P = .99), for residents from other postgraduate years, or for first-time examinees taking the written or oral board examinations during this period. CONCLUSIONS AND RELEVANCE: Implementation of the 2011 ACGME duty hour reform was not associated with a change in general surgery patient outcomes or differences in resident examination performance. The implications of these findings should be considered when evaluating the merit of the 2011 ACGME duty hour reform and revising related policies in the future.

A Look at Demographics and Transition to Virtual Assessments: An Analysis of Bias in the American Board of Surgery General Surgery Certifying Exams.

OBJECTIVE: The goals of this study were (1) to assess if examiner ratings in the American Board of Surgery (ABS) General Surgery Cetifying Exam (CE) are biased based on the gender, race, and ethnicity of the candidate or the examiners, and (2) if the format of delivering of the exams, in-person or virtual, affects how examiners rate candidates. DESIGN: We included every candidate-examiner combination for first time takers of the general surgery oral exam. Total scores and pass/fail outcomes based on the 4 scores given by examiners to candidates were analyzed using multilevel models, with candidates as random effects. Explanatory variables included the gender, race, and ethnicity of candidates and examiners, and the format of the exam (in-person or virtual). Candidates' first attempt scores on the ABS General Surgery Qualifying Exam (QE) were also included in the models to control for the baseline knowledge of the candidate. Three sets of models were evaluated for each demographic variable (gender, race, ethnicity) due to missingness in data. p-values and coefficients of determination R2 were used to quantify the statistical and practical significance of the model coefficients (an existent relationship between the explored variables on CE scores was considered statistically and practically significant if the p-value was lower than 0.01 and R2 higher than 1%). PARTICIPANTS: All first-time takers of the American Board of Surgery General Surgery Certifying Exam from 2016 to 2022 that had demographic data, and the examiners that participated in those exams. RESULTS: The number of candidates/examiners for the 3 sets of models was 8665/514 (gender), 5906/465 (race), and 4678/295 (ethnicity). The demographic variables, format of the exam, or their interactions were not found to significantly relate to examiner-candidate ratings or pass/fail outcomes. The only variable that was significantly related to CE scores was candidates' QE scores, which was added to the models as a measure of candidates' initial knowledge; this held for all models for total scores (F[1,8659] = 1069.89, p-value < 0.01, R2 = 5% [gender models], F(1,5696.3) = 589.13, p-value < 0.01, R2 = 5% [race models], F(1,4459.5) = 278.33, p-value < 0.01, R2 = 5% [ethnicity models]), and pass/fail outcomes (CI = 1.61-1.73, p-value < 0.01, R2 = 3% [gender models], CI = 1.67-1.85, p-value < 0.01, R2 = 3% [race models], CI = 2.17-2.90, p-value < 0.01, R2 = 3% [ethnicity models]). CONCLUSIONS: This study shows that there is not a relationship between candidate and examiner gender, race, or ethnicity, and exam outcomes based on statistical models looking at examiner-candidate ratings and pass/fail outcomes. In addition, the delivery of the certifying exam in a virtual format appears to have no statistical impact on outcomes compared to in-person delivery. This suggests that the ABS is performing well in both demographic bias and virtual space.

Discrepancies in training satisfaction and program completion among 2662 categorical and preliminary general surgery residents.

OBJECTIVE: To compare training experiences of postgraduate year (PGY)-1 and PGY-2 categorical and nondesignated preliminary (NDP) residents and examine NDP educational outcomes. BACKGROUND: There is a paucity of research describing the professional attitudes of NDP surgical trainees. METHODS: Analysis of the 2009 National Study of Expectations and Attitudes of Residents in Surgery survey and American Board of Surgery 2009 to 2011 Resident Rosters. Chi-square and hierarchical logistic regression modeling were employed. RESULTS: A total of 1428 PGY-1s (528 NDPs) and 1234 PGY-2s (189 NDPs) were included. Among PGY-1s, NDPs reported lower program satisfaction than categorical residents (84.2% vs 89.2%, P = .007), and less collegiality with coresidents (P = 0.001). NDPs were less satisfied with their operative experience (P = 0.002) and less frequently enjoyed operating (P < 0.001). NDPs more frequently reported that "the personal cost of surgical training is not worth it" (11.2% vs 3.7%, P < 0.001) and were less frequently committed to completing their surgical training (P < 0.001). Among PGY-2s, NDPs expressed a lower program fit (P = 0.008) and commitment to program completion (P = 0.037). Of 1102 NDP PGY-1s and PGY-2s on the 2009 American Board of Surgery Resident Roster, 347 achieved categorical status by 2011 (31.5%), including 237 National Study of Expectations and Attitudes of Residents in Surgery respondents (34.3%). Marked response differences were found between NDPs who ultimately did and did not achieve categorical status. In hierarchical logistic regression modeling, older age [30-34 years, odds ratio (OR): 0.54; ≥35 years, OR: 0.28), and race/ethnicity (black, OR: 0.28; Hispanic, OR: 0.50) were negatively associated with an NDP attaining categorical status. CONCLUSIONS: The residency experience for NDPs appears less rewarding than for categorical residents. NDPs report less robust operative experience and overall support. Ultimately, only one third of NDPs become categorical surgery residents.

Inter-rater reliability of the occupational violence risk assessment tool for emergency departments.

BACKGROUND: The three-item occupational violence (OV) risk assessment tool was developed and validated for use in emergency departments (EDs). It prompts review of each patient's aggression history, behaviours, and clinical presentation. However, confidence around representativeness and generalisability are needed before widescale adoption; hence we measured the inter-rater reliability of the tool among a large group of emergency nurses. METHODS: A cross-sectional study was conducted between Sep 2021 and Jan 2022. Nurses were directed to a website that hosted an e-learning module about the tool. They were asked to apply the tool to two video scenarios of typical patient presentations. Demographic data, including years of emergency experience, were collected to contextualise their responses. Gwet's Agreement Coefficients (AC1) were calculated to determine inter-rater reliability. RESULTS: There were 135 participants: typically female, under the age of 40 years, with more than 3 years of emergency nursing experience. Overall, there was excellent inter-rater agreement (AC1 =0.752, p = 0.001). This was consistent when years of ED experience was stratified: 0-2 years, AC1 = 0.764, p = 0.002; 3-5 years, AC1 = 0.826, p = 0.001; 6-10 years, AC1 = 0.751, p < 0.001; 11-15 years, AC1 = 0.659, p = 0.004; ≥ 16 years, AC1 = 0.799, p < 0.001. CONCLUSION: The three-item OV risk assessment tool has excellent inter-rater reliability across a large sample of emergency nurses.

Contemporary Practice of General Surgery in the US: Analysis of American Board of Surgery Diplomate Case Logs.

BACKGROUND: The demographics and operative experience of general surgeons certified by the American Board of Surgery were last examined a decade ago. This study examines the contemporary workforce and scope of practice of general surgeons. STUDY DESIGN: Applications of diplomates seeking American Board of Surgery recertification from 2013 to 2017 were reviewed. Demographic data and case logs from the year before submission were analyzed. Total operative volume was examined, as were total volumes for 13 operative domains and 11 abdominal and alimentary tract subdomains. RESULTS: There were 4,735 general surgeons certified by the American Board of Surgery with a mean ± SD age of 53 ± 8 years and included 19% women and 14% international graduates. Regions of practice were 22% Northeast, 31% Southeast, 20% Midwest, 20% West, and 7% Southwest. Practice settings were 86% urban, 9% large rural, 4% small rural, and 1% isolated. Forty-one percent were 10 years, 35% were 20 years, and 24% were 30 years since initial certification. On average, general surgeons performed 417 ± 338 procedures per year, with abdominal, alimentary tract, and endoscopy being the most common. On multivariable analysis, male sex and being midcareer or late career were positively associated with being a high-volume (top quartile) surgeon, whereas age and practicing in either the Northeast or West demonstrated a negative association. CONCLUSIONS: The demographics of general surgeons have remained stable over time, except for an increased proportion of female surgeons. The overall operative experience is similar to years past but is widely variable between surgeons. Periodic analysis of these data is important for education and certification purposes.