ABSTRACT
BACKGROUND: Hepatopancreaticobiliary (HPB) diseases carry high morbidity despite efforts aimed at their reduction. An assessment of their trial characteristics is paramount to determine trial design adequacy and highlight areas for improvement. As such, the aim of this study is to assess HPB surgery trial characteristics, summarize logistic, financial, and practical reasons behind early discontinuation, and propose potential interventions to prevent this in the future. METHODS: All clinical trials investigating HPB surgery registered on ClinicalTrials.gov from October 1st, 2007 (inclusive), to April 20th, 2021 (inclusive), were examined. Trial characteristics were collected including, but not limited to, study phase, duration, patient enrollment size, location, and study design. Peer-reviewed publications associated with the selected trials were also assessed to determine outcome reporting. RESULTS: A total of 1776 clinical trials conducted in 43 countries were identified, the majority of which were conducted in the USA. Of these trials, 32% were reported as "completed" whereas 12% were "discontinued." The most common cause of trial discontinuation was low accrual, which was reported in 37% of terminated studies. These resulted in 413 published studies. Most trials had multiple assignment, randomized, or open-label designs. Treatment was the most common study objective (73%) with pharmacological therapy being the most commonly studied intervention. CONCLUSIONS: The main reasons for early discontinuation of clinical trials in HPB surgery are poor patient recruitment and inadequate funding. Improved trial design, recruitment strategies and increased funding are needed to prevent trial discontinuation and increase publication rates of HPB surgery clinical trials.
Subject(s)
Patient Selection , HumansABSTRACT
BACKGROUND: International medical graduates (IMGs) have been a critical part of the USA healthcare in the past 30 years, especially in small rural and poor counties. However, little to no publications are present on the distribution of these IMGs across general surgery residency programs. METHODS: All freely accessible information on current residents in accredited general surgery residency programs within the USA with at least a 5-year history was explored for IMGs in the current roster using the AMA residency and fellowship database in 2020. Demographic and geographic data were summarized. RESULTS: A total of 230 general surgery residency program were included. Programs were distributed among 46 (92%) states. Of a total 6304 categorical general surgery residents, 573 (9%) were IMGs. Florida (USA) had the highest total number of current IMG general surgery residents with 64. The highest percentage of current IMG residents was found in Maryland (USA) with 31%. IMGs obtained their medical degrees from 76 different countries worldwide. Grenada was the country with the highest origin of IMGs with 77 residents. Central/North America had the highest origin of IMGs with 217 (38%). CONCLUSIONS: IMGs make up a small portion of current general surgery residents in USA programs. Some states host more IMGs than others. Particular countries have contributed more IMGs than others. More research is needed to the challenges facing IMGs and come up with novel solutions for them.
Subject(s)
Foreign Medical Graduates , Internship and Residency , Clinical Competence , Cross-Sectional Studies , Educational Measurement , HumansABSTRACT
BACKGROUND: The Model End-Stage Liver Disease (MELD) has been widely used to predict the mortality and morbidity of various surgical procedures. We aimed to assess the impact of preoperative MELD score on adverse 30-day postoperative outcomes following gastrectomy. METHODS: Patients who underwent elective, non-emergent gastrectomy were identified from the ACS NSQIP 2014-2019 database. Patients were categorized according to a calculated MELD score. The primary outcomes of this study were the 30-day overall complications and major complication rates following gastrectomy. RESULTS: Compared to MELD <11, patients with MELD ≥11 had significantly higher rates of mortality, any complication, and major complication. MELD score ≥11 was significantly associated with any complication (OR 1.73, p = 0.011) and major complications (1.85, p = 0.014) on multivariate analysis. CONCLUSIONS: MELD score ≥11 was associated with poorer outcomes in patients undergoing gastrectomy compared to lower MELD scores.
