BACKGROUND Antibiotic therapy has been proposed as an alternative to surgery for the treatment of appendicitis. METHODS We conducted a pragmatic, nonblinded, noninferiority, randomized trial comparing antibiotic therapy (10-day course) with appendectomy in patients with appendicitis at 25 U.S. centers. The primary outcome was 30-day health status, as assessed with the European Quality of Life-5 Dimensions (EQ-5D) questionnaire (scores range from 0 to 1, with higher scores indicating better health status; noninferiority margin, 0.05 points). Secondary outcomes included appendectomy in the antibiotics group and complications through 90 days; analyses were prespecified in subgroups defined according to the presence or absence of an appendicolith. RESULTS In total, 1552 adults (414 with an appendicolith) underwent randomization; 776 were assigned to receive antibiotics (47% of whom were not hospitalized for the index treatment) and 776 to undergo appendectomy (96% of whom underwent a laparoscopic procedure). Antibiotics were noninferior to appendectomy on the basis of 30-day EQ-5D scores (mean difference, 0.01 points; 95% confidence interval [CI], -0.001 to 0.03). In the antibiotics group, 29% had undergone appendectomy by 90 days, including 41% of those with an appendicolith and 25% of those without an appendicolith. Complications were more common in the antibiotics group than in the appendectomy group (8.1 vs. 3.5 per 100 participants; rate ratio, 2.28; 95% CI, 1.30 to 3.98); the higher rate in the antibiotics group could be attributed to those with an appendicolith (20.2 vs. 3.6 per 100 participants; rate ratio, 5.69; 95% CI, 2.11 to 15.38) and not to those without an appendicolith (3.7 vs. 3.5 per 100 participants; rate ratio, 1.05; 95% CI, 0.45 to 2.43). The rate of serious adverse events was 4.0 per 100 participants in the antibiotics group and 3.0 per 100 participants in the appendectomy group (rate ratio, 1.29; 95% CI, 0.67 to 2.50). CONCLUSIONS For the treatment of appendicitis, antibiotics were noninferior to appendectomy on the basis of results of a standard health-status measure. In the antibiotics group, nearly 3 in 10 participants had undergone appendectomy by 90 days. Participants with an appendicolith were at a higher risk for appendectomy and for complications than those without an appendicolith. (Funded by the Patient-Centered Outcomes Research Institute; CODA ClinicalTrials.gov number, NCT02800785.).
Background The frenetic pace of inpatient care on surgical services can create barriers to resident teaching of students. Students are often concerned that busy surgical residents will not be able to adequately evaluate their performance at the end of a clerkship. Objective To determine whether the addition of a resident preceptor would increase the satisfaction of students rotating through the general surgery portion of the required third-year surgery clerkship. Study Design Before implementing a resident preceptor model, third-year students rotating on general surgery were administered a 24-item web-based survey regarding their experience on the general surgery portion of the surgery clerkship. General surgery residents were similarly surveyed. A resident preceptor model was then introduced. Subsequent students and residents were surveyed. Presurveys and postsurveys were compared and mean responses analyzed.
To the Editor: Inhibitors of sodium–glucose cotransporter 2 (SGLT2) decrease plasma glucose by blocking the reabsorption of glucose at the proximal tubule. 1,2 Case reports have suggested that SGLT2 inhibitors may be associated with an increased risk of diabetic ketoacidosis, which led to a warning from the Food and Drug Adminis tration (FDA) in May 2015. 3,4 The objective of our study was to assess the risk of diabetic ketoaci dosis after the initiation of an SGLT2 inhibitor. Using a large claims database of commercial ly insured patients in the United States (Truven MarketScan), we identified a cohort of adult pa tients (≥18 years of age) who had newly started treatment with either an SGLT2 inhibitor or a dipeptidyl peptidase4 (DPP4) inhibitor between April 1, 2013, and December 31, 2014 (before the FDA warning). DPP4 inhibitors were chosen as the comparator medication because they are simi larly used as a secondline treatment for diabe tes but have no known association with diabetic ketoacidosis. We excluded patients with human immunodeficiency virus infection, endstage renal disease, cancer, type 1 diabetes, or past diabetic ketoacidosis. Our primary outcome was hospitalization for diabetic ketoacidosis (using the primary position code of the International Classifi-cation of Diseases, Ninth Revision) within 180 days after the initiation of an SGLT2 inhibitor or a DPP4 inhibitor. We censored data for patients at the time that they discontinued the initial medi cation, had the outcome, lost insurance cover age, or died. We used 1:1 propensityscore matching to balance 46 characteristics of the patients and Cox regression to estimate hazard ratios and 95% confidence intervals for diabetic ketoacido sis within 180 days after treatment initiation. Predefined sensitivity analyses included shorter durations of followup (30 days and 60 days). All statistical analyses were performed with the use of the validated Aetion platform and R software, version 3.1.2. 5
Purpose: ICU discharge is often delayed by a requirement for intravenous vasopressor medications to maintain normotension. We hypothesised that the administration of midodrine, an oral α1-adrenergic agonist, as adjunct to standard treatment shortens the duration of intravenous vasopressor requirement. Methods: In this multicentre, randomised, controlled trial including three tertiary referral hospitals in the US and Australia, we enrolled adult patients with hypotension requiring a single-agent intravenous vasopressor for ≥ 24 h. Subjects received oral midodrine (20 mg) or placebo every 8 h in addition to standard care until cessation of intravenous vasopressors, ICU discharge, or occurrence of adverse events. The primary outcome was time to vasopressor discontinuation. Secondary outcomes included time to ICU discharge readiness, ICU and hospital lengths of stay, and ICU readmission rates. Results: Between October 2012 and June 2019, 136 participants were randomised, of whom 132 received the allocated intervention and were included in the analysis (modified intention-to-treat approach). Time to vasopressor discontinuation was not different between midodrine and placebo groups (median [IQR], 23.5 [10–54] vs 22.5 [10.4–40] h; difference, 1 h; 95% CI − 10.4 to 12.3 h; p = 0.62). No differences in secondary endpoints were observed. Bradycardia occurred more often after midodrine administration (5 [7.6%] vs 0 [0%], p = 0.02). Conclusion: Midodrine did not accelerate liberation from intravenous vasopressors and was not effective for the treatment of hypotension in critically ill patients.
Background: Trainees and attending surgeons alike have concerns about resident and fellow operative volume/breadth, competency, and overall readiness for practice. This is an important topic within surgical graduate medical education. Our goal was to analyze the change in general surgery trainee operative experience over time by postgraduate year. Methods: Institutional operative records from two corresponding three-month time periods in 2009 and 2018 at the residency program’s main hospital site were reviewed. Cases assisted on by general, vascular, or thoracic surgery trainees were included. The number of cases per level, combination of trainees in each case, and categories of cases were compared over time. Results: There were 1940 cases in 2009 and 1967 cases in 2018 over the respective time periods. The distribution of trainees was different (P .001), with a similar number of PGY-1 and fellow cases, a decrease in PGY-2 and PGY-5 cases, and an increase in PGY-3 and PGY-4 cases. The number of cases with two trainees, double scrubbed cases, increased from 19.6% to 26.8% (P .001). In addition, there were differences in the resident years that double scrubbed cases together, an increase in robotic and endovascular surgery, and a decrease in open cases. Conclusions: This analysis of cases shows that resident operative volume over approximately a decade has been largely preserved, with some change in the distribution of cases based on trainee level, an increase in cases with more than one trainee, and a rise of minimally invasive surgery with a corresponding decrease in open cases.
