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Background/aims: Diverse samples in clinical trials can make findings more generalizable. We sought to characterize the prevalence of clinical trials in the United States that required English fluency for participants to enroll in the trial., Methods: We randomly chose over 10,000 clinical trial protocols registered with ClinicalTrials.gov and examined the inclusion and exclusion criteria of the trials. We compared the relationship of clinical trial characteristics with English fluency inclusion requirements. We merged the ClinicalTrials.gov data with US Census and American Community Survey data to investigate the association of English-language restrictions with ZIP-code-level demographic characteristics of participating institutions. We used Chi-squared tests, t-tests, and logistic regression models for analyses., Results: English fluency requirements have been increasing over time, from 1.7% of trials having such requirements before 2000 to 9.0% after 2010 (p < 0.001 from Chi-squared test). Industry-sponsored trials had low rates of English fluency requirements (1.8%), while behavioral trials had high rates (28.4%). Trials opening in the Northeast of the United States had the highest regional English requirement rates (10.7%), while trials opening in more than one region had the lowest (3.3%, p<0.001). Since 1995, trials opening in ZIP codes with larger Hispanic populations were less likely to have English fluency requirements (odds ratio=0.92 for each 10% increase in proportion of Hispanics, 95% confidence interval=0.86-0.98, p=0.013). Trials opening in ZIP codes with more residents self-identifying as Black/African American (odds ratio=1.87, 95% confidence interval=1.36-2.58, p<0.001 for restricted cubic spline term) or Asian (odds ratio=1.16 for linear term, 95% confidence interval=1.07-1.25, p<0.001) were more likely to have English fluency requirements. ZIP codes with higher poverty rates had trials with more English-language restrictions (odds ratio=1.06 for a 10% poverty rate increase, 95% confidence interval=1.001-1.11, p=0.045). There was a statistically significant interaction between year and intervention type, such that the increase in English fluency requirements was more common for some interventions than for others., Conclusion: The proportion of clinical trials registered with ClinicalTrials.gov that have English fluency requirements for study inclusion has been increasing over time. English-language restrictions are associated with a number of characteristics, including the demographic characteristics of communities in which the sponsoring institutions are located., (© The Author(s) 2015.)

Purpose: To determine outcomes of aneurysmal common iliac arteries (aCIA) used for landing zones (LZs) during endovascular aneurysm repair (EVAR)., Methods: This single-center study retrospectively compared 57 EVAR patients (mean age 72±8 years; 56 men) with 70 aCIAs (diameter ≥20 mm) to 25 control EVAR subjects (mean age 73±7 years; 20 men) with 50 normal (≤15-mm) CIA LZs treated consecutively during the same time interval. The CIA LZ measurements were analyzed using random effects linear mixed models to determine diameter change over time. Life tables were used to estimate freedom from endoleak, reintervention, and all-cause mortality., Results: The mean maximum preoperative CIA diameter in the aCIA LZ group was 24.8±4.5 mm (range 20.0-47.3, median 23.9) vs 13.6±1.5 mm (range 9.2-15.0, median 13.9; p<0.001) in the controls. Nineteen aCIA LZs were treated outside the instructions for use of the device. Median follow-up in the aCIAs LZ cohort was 39.2 months [interquartile range (IQR) 15, 61] vs 49.3 months (IQR 36, 61) in the controls (p=0.06). The rate of aCIA LZ change (0.09 mm/mo, 95% CI 0.07 to 0.1) was significantly greater than controls (0.03 mm/mo, 95% CI -0.009 to 0.07; p<0.0001). No type Ib endoleaks developed in either group; however, aCIA LZ patients had 6 (11%) iliac limb-related reinterventions. There were significantly more endograft-related reinterventions in the aCIA LZ patients (n=10, 14%) compared with controls (n=2, 4%; p=0.06). There was no difference in mortality or freedom from any post-hospital discharge endoleak., Conclusion: Aneurysmal CIA LZs used during EVAR experience greater dilatation compared with normal LZs, but no significant difference in outcome was noted in midterm follow-up. However, an increased incidence of graft limb complications or endograft-related reintervention may be encountered. Use of aCIA LZs appears to be safe; however, greater patient numbers and longer follow-up are needed to understand the clinical implications of morphologic changes in these vessels when used during EVAR., (© The Author(s) 2015.)