Prospective derivation and validation of a NECROtizing Soft tissue InfectionS (NECROSIS) score: An EAST multicenter trial.

BACKGROUND: Although several risk indices have been developed to aid in the diagnosis of NSTIs, these instruments suffer from varying levels of reproducibility and failure to incorporate key clinical variables in model development. The objective of this study was to derive and validate a clinical risk index score - NECROSIS - for identifying NSTIs in emergency general surgery (EGS) patients being evaluated for severe skin and soft tissue infections. METHODS: We performed a prospective study across 16 sites in the US of adult EGS patients with suspected NSTIs over a 30-month period. Variables analyzed included demographics, admission vitals and labs, physical exam, radiographic, and operative findings. The main outcome measure was the presence of NSTI diagnosed clinically at the time of surgery. Multivariate analysis was performed to identify independent predictors for the presence of NSTI using the Hosmer-Lemeshow test and the Akaike information criteria. RESULTS: Of 362 patients, 297 (82%) were diagnosed with a NSTI. Overall mortality was 12.3%. Multivariate analysis identified 3 independent predictors for NSTI: systolic blood pressure ≤ 120 mmHg, violaceous skin, and WBC ≥15 (x103/uL). Multivariate modelling demonstrated Hosmer-Lemeshow goodness of fit (p = 0.9) with a c-statistic for the prediction curve of 0.75. Test characteristics of the NECROSIS score were similar between the derivation and validation cohorts. CONCLUSION: NECROSIS is a simple and potentially useful clinical index score for identifying at-risk EGS patients with NSTIs. Future validation studies are warranted. LEVEL OF EVIDENCE: Diagnostic Tests or Criteria, Level III.

Estimating the size and scope of the academic emergency physician workforce.

BACKGROUND: Academic emergency medicine (EM) is foundational to the EM specialty through the development of new knowledge and clinical training of resident physicians. Despite recent increased attention to the future of the EM workforce, no evaluations have specifically characterized the U.S. academic EM workforce. We sought to estimate the national proportion of emergency physicians (EPs) identified as academic and the proportion of emergency department (ED) visits that take place at academic sites. METHODS: We performed a cross-sectional analysis of EPs and EDs using data from the American Hospital Association, the Centers for Medicare & Medicaid Services, and Doximity's Residency Navigator. EPs were identified as "academic" if they were affiliated with at least one facility determined to be academic, defined as EDs officially designated by the Accreditation Council for Graduate Medical Education (ACGME) as clinical training sites at accredited EM residency programs. Our primary outcomes were to estimate the national proportion of EPs identified as academic and the proportion of ED visits performed at academic sites. RESULTS: Our analytic sample included 26,937 EPs practicing clinically across 4920 EDs and providing care during 130,471,386 ED visits. Among EPs, 11,720 (43.5%) were identified as academic, and among EDs, 635 (12.9%) were identified as academic sites, including 585 adult/general sites, 45 pediatric-specific sites, and 10 sites affiliated with the Department of Veterans Affairs. In 2021, academic EDs provided care for 42,794,106 ED visits or 32.8% of all ED visits nationally. CONCLUSIONS: Approximately four in 10 EPs practice in at least one clinical training site affiliated with an ACGME-accredited EM residency program, and approximately one in three ED visits nationally occur in these academic EDs. We encourage further work using alternative definitions of an academic EPs and EDs, along with longitudinal research to identify trends in the workforce's composition.

Practical Guide to Ethics in Surgical Education Research.

This Guide to Statistics and Methods describes ethical considerations when a study population includes learner participants.

The Utility of ACR TI-RADS in Predicting False-Negative Fine Needle Aspiration for Thyroid Cancer.

BACKGROUND: Thyroid nodule fine needle aspiration (FNA) biopsies are associated with a low false-negative rate. There is limited data regarding the predictive value of American College of Radiology Thyroid Imaging Reporting and Data System for false-negative FNA. METHODS: This single-center retrospective study evaluated 119 patients who underwent thyroidectomy. The association of TR category, along with other clinical variables, with false-negative FNA was evaluated. RESULTS: The overall false-negative rate of FNA was 10.8% (n = 9). False-negative FNAs were associated with younger age (mean 42 years vs 50.6 years, P = .04), larger nodule size (mean 4.4 cm vs 3.2 cm, P = .03), and a lower TR category (median 3 v 4, P = .01). DISCUSSION: Lower TR category, younger age, and larger nodule size were associated with false-negative FNA of thyroid nodules. These findings should be taken into context when counseling patients with thyroid nodules who have a benign FNA.

Practical Guide to Surgical Simulation Research.

This Guide to Statistics and Methods provides an overview of simulation-based education and its impact on surgeon performance.

Practical Guide to Qualitative Research in Surgical Education.

This Guide to Statistics and Methods provides an overview of the selection and application of qualitative research in surgical education.

Practical Guide to Common Flaws With Surgical Education Research.

This Guide to Statistics and Methods provides an overview of common flaws with surgical education research, including how to recognize and avoid them.

Four- and three-year emergency medicine residency graduates perform similarly in their first year of practice compared to experienced physicians.

INTRODUCTION: United States emergency medicine (EM) post-graduate training programs vary in training length, either 4 or 3 years. However, it is unknown if clinical care by graduates from the two curricula differs in the early post-residency period. METHODS: We performed a retrospective observational study comparing measures of clinical care and practice patterns between new graduates from 4- and 3-year EM programs with experienced new physician hires as a reference group. We included emergency department (ED) encounters from a national EM group (2016-19) between newly hired physicians from 4- and 3- year programs and experienced new hires (>2 years' experience) during their first year of practice with the group. Primary outcomes were at the physician-shift level (patients per hour and relative value units [RVUs] per hour) and encounter-level (72-h return visits with admission/transfer and discharge length of stay [LOS]). Secondary outcomes included discharge opioid prescription rates, test ordering, computer tomography (CT) use, and admission/transfer rate. We compared outcomes using multivariable linear regression models that included patient, shift, and facility-day characteristics, and a facility fixed effect. We hypothesized that experienced new hires would be most efficient, followed by new 4-year graduates and then new 3-year graduates. RESULTS: We included 1,084,085 ED encounters by 4-year graduates (n = 39), 3-year graduates (n = 70), and experienced new hires (n = 476). There were no differences in physician-level and encounter-level primary outcomes except discharge LOS was 10.60 min (2.551, 18.554) longer for 4-year graduates compared to experienced new hires. Secondary outcomes were similar among the three groups except 4- and 3-year new graduates were less likely to prescribe opioids to discharged patients, -3.70% (-5.768, -1.624) and - 3.38% (-5.136, -1.617) compared to experienced new hires. CONCLUSIONS: In this sample, measures of clinical care and practice patterns related to efficiency, safety, and flow were largely similar between the physician groups; however, experienced new hires were more likely to prescribe opioids than new graduates. These results do not support recommending a specific length of residency training in EM.

Practical Guide to Statistical Considerations in Clinical Trials in Surgery.

This Guide to Statistics and Methods discusses key statistical considerations in the conduct of randomized clinical trials in surgery.

Practical Guide to Quality Control in Surgical Trials.

This Guide to Statistics and Methods outlines the elements of clinical trial quality control that are important to safeguarding data integrity and addressing the unique challenges of procedural trials.

Perception of Treatment Success and Impact on Function with Antibiotics or Appendectomy for Appendicitis: A Randomized Clinical Trial with an Observational Cohort.

OBJECTIVE: To compare secondary patient reported outcomes of perceptions of treatment success and function for patients treated for appendicitis with appendectomy vs. antibiotics at 30 days. SUMMARY BACKGROUND DATA: The Comparison of Outcomes of antibiotic Drugs and Appendectomy trial found antibiotics noninferior to appendectomy based on 30-day health status. To address questions about outcomes among participants with lower socioeconomic status, we explored the relationship of sociodemographic and clinical factors and outcomes. METHODS: We focused on 4 patient reported outcomes at 30 days: high decisional regret, dissatisfaction with treatment, problems performing usual activities, and missing >10 days of work. The randomized (RCT) and observational cohorts were pooled for exploration of baseline factors. The RCT cohort alone was used for comparison of treatments. Logistic regression was used to assess associations. RESULTS: The pooled cohort contained 2062 participants; 1552 from the RCT. Overall, regret and dissatisfaction were low whereas problems with usual activities and prolonged missed work occurred more frequently. In the RCT, those assigned to antibiotics had more regret (Odd ratios (OR) 2.97, 95% Confidence intervals (CI) 2.05-4.31) and dissatisfaction (OR 1.98, 95%CI 1.25-3.12), and reported less missed work (OR 0.39, 95%CI 0.27-0.56). Factors associated with function outcomes included sociodemographic and clinical variables for both treatment arms. Fewer factors were associated with dissatisfaction and regret. CONCLUSIONS: Overall, participants reported high satisfaction, low regret, and were frequently able to resume usual activities and return to work. When comparing treatments for appendicitis, no single measure defines success or failure for all people. The reported data may inform discussions regarding the most appropriate treatment for individuals. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT02800785.

Direct vs Video Laryngoscopy for Difficult Airway Patients in the Emergency Department: A National Emergency Airway Registry Study.

INTRODUCTION: Previous studies suggest improved intubation success using video laryngoscopy (VL) vs direct laryngoscopy (DL), yet recent randomized trials have not shown clear benefit of one method over the other. These studies, however, have generally excluded difficult airways and rapid sequence intubation. In this study we looked to compare first-pass success (FPS) rates between VL and DL in adult emergency department (ED) patients with difficult airways. METHODS: We conducted a secondary analysis of prospectively collected observational data in the National Emergency Airway Registry (NEAR) (January 2016-December 2018). Variables included demographics, indications, methods, medications, devices, difficult airway characteristics, success, and adverse events. We included adult ED patients intubated with VL or DL who had difficult airways identified by gestalt or anatomic predictors. We stratified VL by hyperangulated (HAVL) vs standard geometry VL (SGVL). The primary outcome was FPS, and the secondary outcome was comparison of adverse event rates between groups. Data analyses included descriptive statistics with cluster-adjusted 95% confidence intervals (CI). RESULTS: Of 18,123 total intubations, 12,853 had a predicted or identified anatomically difficult airway. The FPS for difficult airways was 89.1% (95% CI 85.9-92.3) with VL and 77.7% (95% CI 75.7-79.7) with DL (P <0.00001). The FPS rates were similar between VL subtypes for all difficult airway characteristics except airways with blood or vomit, where SGVL FPS (87.3%; 95% CI 85.8-88.8) was slightly better than HAVL FPS (82.4%; 95% CI, 80.3-84.4). Adverse event rates were similar except for esophageal intubations and vomiting, which were both less common in VL than DL. Esophageal intubations occurred in 0.4% (95% CI 0.1-0.7) of VL attempts and 1.5% (95% CI 1.1-1.9) of DL attempts. Vomiting occurred in 0.6% (95% CI 0.5-0.7) of VL attempts and 1.4% (95% CI 0.9-1.9) of DL attempts. CONCLUSION: Analysis of the NEAR database demonstrates higher first-pass success with VL compared to DL in patients with predicted or anatomically difficult airways, and reduced rate of esophageal intubations and vomiting.

Association of Patient Belief About Success of Antibiotics for Appendicitis and Outcomes: A Secondary Analysis of the CODA Randomized Clinical Trial.

Importance: A patient's belief in the likely success of a treatment may influence outcomes, but this has been understudied in surgical trials. Objective: To examine the association between patients' baseline beliefs about the likelihood of treatment success with outcomes of antibiotics for appendicitis in the Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) trial. Design, Setting, and Participants: This was a secondary analysis of the CODA randomized clinical trial. Participants from 25 US medical centers were enrolled between May 3, 2016, and February 5, 2020. Included in the analysis were participants with appendicitis who were randomly assigned to receive antibiotics in the CODA trial. After informed consent but before randomization, participants who were assigned to receive antibiotics responded to a baseline survey including a question about how successful they believed antibiotics could be in treating their appendicitis. Interventions: Participants were categorized based on baseline survey responses into 1 of 3 belief groups: unsuccessful/unsure, intermediate, and completely successful. Main Outcomes and Measures: Three outcomes were assigned at 30 days: (1) appendectomy, (2) high decisional regret or dissatisfaction with treatment, and (3) persistent signs and symptoms (abdominal pain, tenderness, fever, or chills). Outcomes were compared across groups using adjusted risk differences (aRDs), with propensity score adjustment for sociodemographic and clinical factors. Results: Of the 776 study participants who were assigned antibiotic treatment in CODA, a total of 425 (mean [SD] age, 38.5 [13.6] years; 277 male [65%]) completed the baseline belief survey before knowing their treatment assignment. Baseline beliefs were as follows: 22% of participants (92 of 415) had an unsuccessful/unsure response, 51% (212 of 415) had an intermediate response, and 27% (111 of 415) had a completely successful response. Compared with the unsuccessful/unsure group, those who believed antibiotics could be completely successful had a 13-percentage point lower risk of appendectomy (aRD, -13.49; 95% CI, -24.57 to -2.40). The aRD between those with intermediate vs unsuccessful/unsure beliefs was -5.68 (95% CI, -16.57 to 5.20). Compared with the unsuccessful/unsure group, those with intermediate beliefs had a lower risk of persistent signs and symptoms (aRD, -15.72; 95% CI, -29.71 to -1.72), with directionally similar results for the completely successful group (aRD, -15.14; 95% CI, -30.56 to 0.28). Conclusions and Relevance: Positive patient beliefs about the likely success of antibiotics for appendicitis were associated with a lower risk of appendectomy and with resolution of signs and symptoms by 30 days. Pathways relating beliefs to outcomes and the potential modifiability of beliefs to improve outcomes merit further investigation. Trial Registration: ClinicalTrials.gov Identifier: NCT02800785.

Practical Guide to Designing a Clinical Trial in Surgery.

This Guide to Statistics and Methods outlines the key elements that need to be considered during the design phase of a surgical clinical trial.

Faculty Scoring of General Surgery Residency Interviewees: A Comparison of In-Person and Virtual Interview Formats.

OBJECTIVE: With new rules regarding social distancing and non-essential travel bans, we sought to determine if faculty scoring of general surgery applicants would differ between the in-person interview (IPI) and virtual interview (VI) platforms. DESIGN: A single institution, retrospective review comparing faculty evaluation scores of applicant interviewees in the 2019 and 2020 MATCH® application cycles (IPIs) and the 2021 and 2022 application cycle (VIs) was conducted. Faculty scored applicants using a 5-point Likert scale in 7 areas of assessment and assigned each student to 1 of 4 tiers (tier 1 highest). A composite score for the 7 assessments (maximum score 35) was calculated. Mean and composite scores and tiers were compared between VI and IPI cycles and adjusted for within-interviewer correlations. The variance of the 2 groups were also compared. SETTING: Harbor-UCLA Medical Center, an academic, tertiary care hospital. PARTICIPANTS: General Surgery applicants for the 2019 to 2022 MATCH® application cycles. RESULTS: Four hundred forty-one faculty IPI ratings of General Surgery applicants were compared to 531VI ratings. No difference in mean composite scores, individual assessments, or tier ranking. Less variance was identified in the VI group for academic credentials (0.6 vs 0.6, p = 0.01), strength of letters (0.7 vs 0.4, p = 0.005), communication skills (0.4 vs 0.6, p = 0.01), personal qualities (0.2 vs 0.5, p = 0.02), overall sense of fit for program (0.6 vs 0.9, p = 0.01), and tier ranking (0.3 vs 0.4, p = 0.004). CONCLUSIONS: Faculty ratings of General Surgery applicants in the VI format appear to be similar to IPI. However, faculty ratings of VI applicants demonstrated less variability in scores in most assessments. This finding is potentially concerning, as it may suggest an inability of VI to detect subtle differences between applicants as comparted to IPI.

Analysis of Outcomes Associated With Outpatient Management of Nonoperatively Treated Patients With Appendicitis.

Importance: In the Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) trial, which found antibiotics to be noninferior, approximately half of participants randomized to receive antibiotics had outpatient management with hospital discharge within 24 hours. If outpatient management is safe, it could increase convenience and decrease health care use and costs. Objective: To assess the use and safety of outpatient management of acute appendicitis. Design, Setting, and Participants: This cohort study, which is a secondary analysis of the CODA trial, included 776 adults with imaging-confirmed appendicitis who received antibiotics at 25 US hospitals from May 1, 2016, to February 28, 2020. Exposures: Participants randomized to antibiotics (intravenous then oral) could be discharged from the emergency department based on clinician judgment and prespecified criteria (hemodynamically stable, afebrile, oral intake tolerated, pain controlled, and follow-up confirmed). Outpatient management and hospitalization were defined as discharge within or after 24 hours, respectively. Main Outcomes and Measures: Outcomes compared among patients receiving outpatient vs inpatient care included serious adverse events (SAEs), appendectomies, health care encounters, satisfaction, missed workdays at 7 days, and EuroQol 5-dimension (EQ-5D) score at 30 days. In addition, appendectomy incidence among outpatients and inpatients, unadjusted and adjusted for illness severity, was compared. Results: Among 776 antibiotic-randomized participants, 42 (5.4%) underwent appendectomy within 24 hours and 8 (1.0%) did not receive their first antibiotic dose within 24 hours, leaving 726 (93.6%) comprising the study population (median age, 36 years; range, 18-86 years; 462 [63.6%] male; 437 [60.2%] White). Of these participants, 335 (46.1%; site range, 0-89.2%) were discharged within 24 hours, and 391 (53.9%) were discharged after 24 hours. Over 7 days, SAEs occurred in 0.9 (95% CI, 0.2-2.6) per 100 outpatients and 1.3 (95% CI, 0.4-2.9) per 100 inpatients; in the appendicolith subgroup, SAEs occurred in 2.3 (95% CI, 0.3-8.2) per 100 outpatients vs 2.8 (95% CI, 0.6-7.9) per 100 inpatients. During this period, appendectomy occurred in 9.9% (95% CI, 6.9%-13.7%) of outpatients and 14.1% (95% CI, 10.8%-18.0%) of inpatients; adjusted analysis demonstrated a similar difference in incidence (-4.0 percentage points; 95% CI, -8.7 to 0.6). At 30 days, appendectomies occurred in 12.6% (95% CI, 9.1%-16.7%) of outpatients and 19.0% (95% CI, 15.1%-23.4%) of inpatients. Outpatients missed fewer workdays (2.6 days; 95% CI, 2.3-2.9 days) than did inpatients (3.8 days; 95% CI, 3.4-4.3 days) and had similar frequency of return health care visits and high satisfaction and EQ-5D scores. Conclusions and Relevance: These findings support that outpatient antibiotic management is safe for selected adults with acute appendicitis, with no greater risk of complications or appendectomy than hospital care, and should be included in shared decision-making discussions of patient preferences for outcomes associated with nonoperative and operative care. Trial Registration: ClinicalTrials.gov Identifier: NCT02800785.

The Impact of Primary Care Physicians on the Surgical Presentation and Outcomes of Colorectal Cancer in Vulnerable Populations.

BACKGROUND: Multiple socioeconomic and clinical factors have been implicated in the health disparities that exist amongst vulnerable populations with colorectal cancer. Efforts have been directed toward addressing these factors to improve outcomes. We evaluate the impact of primary care physicians (PCP) on the surgical presentation and outcomes of colorectal cancer at a safety-net hospital. METHODS: A retrospective chart review of 331 patients diagnosed with colorectal adenocarcinoma between 2014 and 2020 at a single-institution urban county medical center. RESULTS: The cohort was predominantly male (59%) and Hispanic (52.1%). Thirty-two percent of patients had a PCP at time of diagnosis. Patients with PCPs compared to those without PCPs had significantly lower rates of acute presentation (perforation or obstruction) (17.0 vs 38.1%, P < .001), higher rates of surgical resection (83.0 vs 70.7%, P = .016), and were less likely to have metastatic disease at presentation (20.4 vs 33.5%, P = .02). Overall, having a PCP also improved probability of survival (HR 1.36, P < .04). CONCLUSION: Having a PCP at the time of colorectal cancer diagnosis is associated with improved outcomes in a safety-net population, with significant differences in surgical presentation and resection.

Self-selection vs Randomized Assignment of Treatment for Appendicitis.

Importance: For adults with appendicitis, several randomized clinical trials have demonstrated that antibiotics are an effective alternative to appendectomy. However, it remains unknown how the characteristics of patients in such trials compare with those of patients who select their treatment and whether outcomes differ. Objective: To compare participants in the Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) randomized clinical trial (RCT) with a parallel cohort study of participants who declined randomization and self-selected treatment. Design, Setting, and Participants: The CODA trial was conducted in 25 US medical centers. Participants were enrolled between May 3, 2016, and February 5, 2020; all participants were eligible for at least 1 year of follow-up, with all follow-up ending in 2021. The randomized cohort included 1094 adults with appendicitis; the self-selection cohort included patients who declined participation in the randomized group, of whom 253 selected appendectomy and 257 selected antibiotics. In this secondary analysis, characteristics and outcomes in both self-selection and randomized cohorts are described with an exploratory analysis of cohort status and receipt of appendectomy. Interventions: Appendectomy vs antibiotics. Main Outcomes and Measures: Characteristics among participants randomized to either appendectomy or antibiotics were compared with those of participants who selected their own treatment. Results: Clinical characteristics were similar across the self-selection cohort (510 patients; mean age, 35.8 years [95% CI, 34.5-37.1]; 218 female [43%; 95% CI, 39%-47%]) and the randomized group (1094 patients; mean age, 38.2 years [95% CI, 37.4-39.0]; 386 female [35%; 95% CI, 33%-38%]). Compared with the randomized group, those in the self-selection cohort were less often Spanish speaking (n = 99 [19%; 95% CI, 16%-23%] vs n = 336 [31%; 95% CI, 28%-34%]), reported more formal education (some college or more, n = 355 [72%; 95% CI, 68%-76%] vs n = 674 [63%; 95% CI, 60%-65%]), and more often had commercial insurance (n = 259 [53%; 95% CI, 48%-57%] vs n = 486 [45%; 95% CI, 42%-48%]). Most outcomes were similar between the self-selection and randomized cohorts. The number of patients undergoing appendectomy by 30 days was 38 (15.3%; 95% CI, 10.7%-19.7%) among those selecting antibiotics and 155 (19.2%; 95% CI, 15.9%-22.5%) in those who were randomized to antibiotics (difference, 3.9%; 95% CI, -1.7% to 9.5%). Differences in the rate of appendectomy were primarily observed in the non-appendicolith subgroup. Conclusions and Relevance: This secondary analysis of the CODA RCT found substantially similar outcomes across the randomized and self-selection cohorts, suggesting that the randomized trial results are generalizable to the community at large. Trial Registration: ClinicalTrials.gov Identifier: NCT02800785.