New Trends at 25 Years: An American Board of Surgery Academic Certifying Examination Review Course.

BACKGROUND: In the 1980s, a small research group began identifying variables affecting applicant success on the American Board of Surgery (ABS) Certifying Examination (CE). We now report success and trends as we complete 25 years. We had multiple challenges as identified through faculty focus groups and participant feedback that needed to be addressed: increase the national optics of the program, integrate new innovative experiences, maintain the integrity of the collected data on excel files, incorporate national trends in surgery, attract experienced clinical volunteer faculty and staff, security of capital, and schedule management. METHOD: The primary purpose of the program is to define the root cause interfering with success on the ABS CE. All of the listed changes in course design (2012-2016) were entered into excel files along with participants demographics, including results of the pretesting modules, the communication inventory, all self-reported stressors, and interview results to track the effect of faculty interventions, trends and ABS outcomes. RESULTS: The profiles of the participants have changed over time, including: marital status, presence of DSM-5 stressors, gender, fellowship training, study habits, financial burdens, and international graduate status. International graduates demonstrated communication issues that were present, though rarely addressed, during residency training. The gradual absorption of junior faculty allowed a seamless transition over time as part of the succession plan. Although the national success rates on the CE were 72% to 80%, this program\u27s success rate still remained in the 90 percentile (94%-97%) for those who followed their education improvement plan. Deidentified excel files will be converted to REDCap for preservation and analysis. DISCUSSION: The small course design has continued to be effective at identifying variables that interfere with success on the CE examination. The inclusion of additional PhD education scientists facilitated focused individual interventions. A pilot program for international graduate status residents is in development

RECOMBINANT HUMAN INTERLEUKIN-1 RECEPTOR ANTAGONIST IN THE TREATMENT OF PATIENTS WITH SEPSIS SYNDROME - RESULTS FROM A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL

Objective.-To further define the safety and efficacy of recombinant human interleukin 1 receptor antagonist (rhlL-1ra) in the treatment of sepsis syndrome. Study Design.-Randomized, double-blind, placebo-controlled, multicenter, multinational clinical trial. Population.-A total of 893 patients with sepsis syndrome received an intravenous loading dose of rhIL-1ra, 100 mg, or placebo followed by a continuous 72-hour intravenous infusion of rhIL-1ra (1.0 or 2.0 mg/kg per hour) or placebo. Outcome Measure.-Twenty-eight-day all-cause mortality. Results.-There was not a significant increase in survival time for rhIL-1ra treatment compared with placebo among all patients who received the study medication (n=893; generalized Wilcoxon statistic, P=.22) or among patients with shock at study entry (n=713; generalized Wilcoxon statistic, P=.23), the two primary efficacy analyses specified a priori for this trial. Results from secondary analyses suggest an increase in survival time with rhIL-1ra treatment among patients with dysfunction of one or more organs (n=563; linear dose-response, P=.009). Retrospective analysis demonstrated an increase In survival time with rhIL-1ra treatment among patients with a predicted risk of mortality of 24% or greater (n=580; linear dose-response, P=.005) as well as among patients with both dysfunction of one or more organs and a predicted risk of mortality of 24% or greater (n=411; linear dose-response, P=.002). Conclusions.-There was not a statistically significant increase in survival time for rhIL-1ra treatment compared with placebo among all patients who received the study medication or among patients with shock at study entry. Secondary and retrospective analyses of efficacy suggest that treatment with rhIL-1ra results in a dose-related increase in survival time among patients with sepsis who have organ dysfunction and/or a predicted risk of mortality of 24% or greate

A clinical trial of progesterone for severe traumatic brain injury.

BACKGROUND: Progesterone has been associated with robust positive effects in animal models of traumatic brain injury (TBI) and with clinical benefits in two phase 2 randomized, controlled trials. We investigated the efficacy and safety of progesterone in a large, prospective, phase 3 randomized clinical trial. METHODS: We conducted a multinational placebo-controlled trial, in which 1195 patients, 16 to 70 years of age, with severe TBI (Glasgow Coma Scale score, 648 [on a scale of 3 to 15, with lower scores indicating a reduced level of consciousness] and at least one reactive pupil) were randomly assigned to receive progesterone or placebo. Dosing began within 8 hours after injury and continued for 120 hours. The primary efficacy end point was the Glasgow Outcome Scale score at 6 months after the injury. RESULTS: Proportional-odds analysis with covariate adjustment showed no treatment effect of progesterone as compared with placebo (odds ratio, 0.96; confidence interval, 0.77 to 1.18). The proportion of patients with a favorable outcome on the Glasgow Outcome Scale (good recovery or moderate disability) was 50.4% with progesterone, as compared with 50.5% with placebo. Mortality was similar in the two groups. No relevant safety differences were noted between progesterone and placebo. CONCLUSIONS: Primary and secondary efficacy analyses showed no clinical benefit of progesterone in patients with severe TBI. These data stand in contrast to the robust preclinical data and results of early single-center trials that provided the impetus to initiate phase 3 trials. (Funded by BHR Pharma; SYNAPSE ClinicalTrials.gov number, NCT01143064.)