Characterization of Underrepresented Populations in Modern Era Clinical Trials Involving Radiation Therapy.

PURPOSE: The demographic composition of modern radiation therapy (RT) clinical trials is incompletely studied. Understanding and minimizing disparities in clinical trials is critical to ensure health equity and the generalizability of research findings. METHODS AND MATERIALS: Clinicaltrials.gov was searched to identify RT clinical trials that occurred from 1996 to 2019. A total of 1242 trials were reviewed for patient characteristics. The demographic composition of the studies was summarized by the frequency and percentage of patients by race, gender, and ethnicity. The racial composition of the study population was compared with the 2018 US Census using a 1-sample χ2 test. Subgroup racial composition was compared using χ2 tests of independence. Analyses used a complete case approach. RESULTS: A total of 122 trials met the inclusion criteria, and 121 of these (99.1%) reported race. Trial subgroups included 63 trials in the United States (51.6%), 9 proton therapy trials (7.4%), 34 RT toxicity mitigation or prevention trials (27.9%), 24 trials for female cancer (19.7%), and 17 trials for male cancer (13.9%). US clinical trials overall, US RT toxicity mitigation or prevention trials, US trials for female cancer, and US trials for male cancer had significantly different racial compositions compared with the 2018 US Census data (P < .001 for all). Compared with all clinical trials, those for proton therapy had the largest magnitude of significantly lower enrollment of participants who identified their race as Black, Asian, or other (P < .001). CONCLUSIONS: This study characterized the racial composition of prospective RT clinical trials in a modern cohort. The racial population represented across multiple categories in the United States differed significantly from US census data and was most pronounced in trials evaluating proton therapy. This is a benchmark study for future efforts to characterize and balance the participation of underrepresented populations in RT clinical trials.

Aortic Remodeling and Clinical Outcomes Following Thoracic Endovascular Aortic Repair for Blunt Thoracic Aortic Injury.

BACKGROUND: There is currently limited data assessing the long-term consequences of thoracic endovascular aortic repair (TEVAR) in otherwise healthy aortic segments remote from the site of endograft coverage. The aim of this study is to retrospectively evaluate aortic remodeling and long-term outcomes of blunt thoracic aortic injury (BTAI) patients treated with TEVAR. Our hypothesis is that significant changes to the aorta proximal to the graft-covered segment are suspected following TEVAR. METHODS: An institutional review board-approved retrospective review of patients who underwent TEVAR for BTAI at a level I trauma center from 2004 to 2018 was performed. Forty-six patients were identified and of these, 32 patients with high-resolution computed tomographic angiography imaging follow-up were included in the study. Computed tomographic angiography measurements of aortic dimensions and branch vessels proximal, distal, and adjacent to the stent grafted segment were recorded preprocedure and postprocedure and analyzed. Primary device-related outcomes such as birdbeaking, mural thrombus, stent migration, and persistent endoleak were assessed. Patient outcomes including mortality, graft-related morbidity, and need for secondary interventions were also analyzed. RESULTS: Mean follow-up of the selected patients in the study was 1.52 y (range, 0.06-8.0 y). Following TEVAR, the ascending aortic length increased significantly (mean 5.7 ± 4.6 mm, P < 0.001). The mean diameters of the ascending aorta (1.5 ± 1.5, P < 0.001 mm), the midaortic arch (1.3 ± 1.7 mm, P < 0.001), and proximal and the distal endograft landing zones (1.9 ± 2.1 mm and 2.2 ± 1.6 mm, respectively, P < 0.001) also increased significantly following TEVAR. Clinically relevant device-related outcomes occurred with the presence of endograft infolding and subsequent development of endograft mural thrombus (P < 0.001). The need for secondary intervention following TEVAR for BTAI was associated with endograft mural thrombus (P < 0.05). CONCLUSIONS: TEVAR for BTAI causes significant geometric changes in the aorta proximal to the stented grafted segment of the aorta. Direct consequences of the graft at the stented segment includes mural thrombus development within the endograft which was associated with the need for secondary intervention. Although clinical significance is yet to be determined, post-TEVAR changes in aortic architecture warrant continued aortic surveillance following BTAI.

Distal biceps tendon history, updates, and controversies: from the closed American Shoulder and Elbow Surgeons meeting-2015.

Understanding of the distal biceps anatomy, mechanics, and biology during the last 75 years has greatly improved the physician's ability to advise and to treat patients with ruptured distal tendons. The goal of this paper is to review the past and current advances on complete distal biceps ruptures as well as controversies and future directions that were discussed and debated during the closed American Shoulder and Elbow Surgeons meeting in 2015.