Are orthopedic clinical trials representative? An analysis of race and ethnicity reported in clinical trials between 2007 and 2022 : Running title: representation of clinical trials in orthopedic surgery.

INTRODUCTION: Prior studies investigating the racial and ethnic representation of orthopedic trial participants have found low rates of reporting, but these studies are dated due to the passing of the National Institutes of Health Final Rule in 2017 requiring the reporting of racial and ethnic data among clinical trials. Therefore, we evaluated the representativeness of orthopedic clinical trials before and after the Final Rule. METHODS: A cross-sectional survey of orthopaedic clinical trials registered at ClinicalTrials.gov between October 1, 2007 and May 20, 2023 was conducted. After identifying and screening 23,752 clinical trials, 1564 trials were included in the analysis. Trials started before the implementation of the Final Rule on January 18, 2017 were grouped and compared to trials that began after. Odds ratios (OR) were utilized to identify trial characteristics associated with reporting race/ethnicity data. One-proportion z tests compared the representation of each racial and ethnic category to the 2020 United States Census. RESULTS: In total, 34% (544 of 1564) of orthopedic clinical trials evaluated reported the race of participants, while 28% (438 of 1564) reported ethnicity. Trials registered after the Final Rule were more likely to report racial (OR: 5.15, 95%CI: 3.72-7.13, p < 0.001) and ethnic (OR: 3.23, 95%CI: 2.41-4.33, p < 0.001) representation of participants. Compared with the distribution of race and ethnicity reported by the United States 2020 Census, orthopedic trials had 16.6% more White participants (95% CI 16.4%, 16.8%; p < 0.001), 3.2% fewer Black participants (95%CI 3.1%, 3.3%; p < 0.001), and 5.7% fewer Hispanic/Latino participants (95%CI 5.2%, 6.2%; p < 0.001). Trials with enrollment sizes over 100 participants were also more likely to report race and ethnicity, with odds increasing with increased sample size. CONCLUSIONS: The Final Rule marginally improved the reporting of race and ethnicity in orthopedic clinical trials, and underrepresentation of Black or African American, Multiracial, and Hispanic populations persists. LEVEL OF EVIDENCE: III.

A critical view: Examining disparities regarding timely cholecystectomy.

BACKGROUND: Implicit bias may prevent patients with abdominal pain from receiving optimal workup and treatment. We hypothesized that patients from socially disadvantaged backgrounds would be more likely to experience delays in receiving operative treatment for cholecystitis. To study this question, we examined factors related to having a prior emergency department presentation for abdominal pain (prior emergency department visit) within 3 months of urgent cholecystectomy. METHODS: We performed a retrospective analysis of consecutive patients who received an urgent cholecystectomy at an urban safety net public hospital between July 2019 and December 2022. The main outcome of interest was prior emergency department visit within 3 months of index cholecystectomy. We examined patient age, sex, race, ethnicity, preferred language, insurance, and employment status. Bivariate comparisons and logistic regression were used to determine the relationship between patient factors and prior emergency department visit. RESULTS: Of 508 cholecystectomy patients, 138 (27.2%) had a prior emergency department visit in the 3 months preceding their surgery. In bivariate analysis, younger age, Black race, Hispanic ethnicity, non-English preferred language, and type of insurance (P < .05) were associated with prior emergency department visit. In regression, younger age, Black race, Hispanic ethnicity, and having Medicare or being uninsured were associated with higher odds of having a prior emergency department visit. CONCLUSION: More than 1 in 4 patients had an evaluation for abdominal pain within 3 months of having an urgent cholecystectomy, and these patients were more likely to be from socially disadvantaged backgrounds. Standardized evaluation pathways for abdominal pain are needed to reduce disparities from institutional or implicit bias.

Appointment wait times for surgical care in the Veterans Health Administration and Community Care Program.

BACKGROUND: The Veterans Health Administration has been criticized for long wait times; however, studies indicate that Veterans Health Administration wait times are shorter than those for the Veterans Health Administration's Community Care Program. Previous studies have analyzed primary care wait times, but few have compared surgical specialties. METHODS: Using a publicly available data set of veteran appointments compiled from the Veterans Health Administration's Corporate Data Warehouse, a nationally representative database containing 623,868 surgical consults from January 1 to June 30, 2021, mean differences in wait times between the Veterans Health Administration and the Community Care Program were calculated across surgical specialties. RESULTS: In total, 49.6% of the surgical consults placed during the study period were for the Community Care Program. Across all surgical specialties, wait times were shorter in the Veterans Health Administration. Cardiothoracic surgery had the shortest mean wait times (23.1 days Veterans Health Administration; 30.0 days Community Care Program). The greatest difference in wait times was observed in plastic surgery, with Community Care Program appointments occurring 15.8 days later than Veterans Health Administration appointments on average. CONCLUSION: Across all surgical specialties, the Veterans Health Administration had shorter wait times than the Community Care Program during the study period.

TRI-SCORE is superior to EuroSCORE II and STS-Score in mortality prediction following transcatheter edge-to-edge tricuspid valve repair.

BACKGROUND: The development of transcatheter tricuspid edge-to-edge repair for tricuspid regurgitation is a therapeutic milestone but a specific periprocedural risk assessment tool is lacking. TRI-SCORE has recently been introduced as a dedicated risk score for tricuspid valve surgery. AIMS: This study analyzes the predictive performance of TRI-SCORE following transcatheter edge-to-edge tricuspid valve repair. METHODS: 180 patients who underwent transcatheter tricuspid valve repair at Ulm University Hospital were consecutively included and stratified into three TRI-SCORE risk groups. The predictive performance of TRI-SCORE was assessed throughout a follow-up period of 30 days and up to 1 year. RESULTS: All patients had severe tricuspid regurgitation. Median EuroSCORE II was 6.4% (IQR 3.8-10.1%), median STS-Score 8.1% (IQR 4.6-13.4%) and median TRI-SCORE 6.0 (IQR 4.0-7.0). 64 patients (35.6%) were in the low TRI-SCORE group, 91 (50.6%) in the intermediate and 25 (13.9%) in the high-risk groups. The procedural success rate was 97.8%. 30-day mortality was 0% in the low-risk group, 1.3% in the intermediate-risk and 17.4% in the high-risk groups (p < 0.001). During a median follow-up of 168 days mortality was 0%, 3.8% and 52.2%, respectively (p < 0.001). The predictive performance of TRI-SCORE was excellent (AUC for 30-day mortality: 90.3%, for one-year mortality: 93.1%) and superior to EuroSCORE II (AUC 56.6% and 64.4%, respectively) and STS-Score (AUC 61.0% and 59.0%, respectively). CONCLUSION: TRI-SCORE is a valuable tool for prediction of mortality after transcatheter edge-to-edge tricuspid valve repair and its performance is superior to EuroSCORE II and STS-Score. In a monocentric cohort of 180 patients undergoing edge-to-edge tricuspid valve repair TRI-SCORE predicted 30-day and up to one-year mortality more reliably than EuroSCORE II and STS-Score. AUC area under the curve, 95% CI 95% confidence interval.