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.

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.