of participants who are members of racial and ethnic minority groups in clinical trials enhances inclusivity in the scientific process and generalizability of results.OBJECTIVE To assess participant race and ethnicity in pediatric clinical trials published from 2011 to 2020. DESIGN, SETTING, AND PARTICIPANTSThis cross-sectional study examined articles reporting pediatric clinical trials conducted in the US published in 5 leading general pediatric and 5 leading general medical journals from January 1, 2011, to December 31, 2020. MAIN OUTCOMES AND MEASURESReporting of participant race and ethnicity and comparison of enrolled participants vs US census populations of pediatric racial and ethnic groups in published clinical trials. RESULTSThe study included 612 articles reporting pediatric clinical trials during the study period, with 565 618 total participants (median per trial, 200 participants [IQR, 90-571 participants]). Of the 612 articles, 486 (79.4%) reported participant race and 338 (55.2%) reported participant ethnicity. From 2011 to 2020, relative rates of reporting of participant race increased by 7.9% per year (95% CI, 0.2%-16.3% per year) and reporting of ethnicity increased by 11.4% per year (95% CI, 4.8%-18.4% per year). Among articles reporting race and ethnicity, the method of assignment was not reported in 261 of 511 articles (51.1%) and 207 of 359 articles (57.7%), respectively. Black/African American children were enrolled proportionally more than the US population of Black/African American children (odds ratio [OR], 1.88; 95% CI, 1.87-1.89). Hispanic/Latino children were enrolled commensurately with the US population of Hispanic/Latino children (OR, 1.02; 95% CI, 1.01-1.03). American Indian/Alaska Native (OR, 0.82; 95% CI, 0.79-0.85), Asian (OR, 0.56; 95% CI, 0.55-0.57), and Native Hawaiian/Pacific Islander (OR, 0.66; 95% CI, 0.61-0.72) children were enrolled significantly less compared with the respective US populations of these groups. White children were enrolled less than expected (OR, 0.84; 95% CI, 0.84-0.85) but represented 188 156 (46.0%) of participants in trials reporting race or ethnicity. CONCLUSIONS AND RELEVANCEThis cross-sectional study revealed that the proportion of published pediatric clinical trials that reported participant race and ethnicity increased from 2011 to 2020, but participant race and ethnicity were still underreported. Disparities existed in pediatric clinical trial enrollment of American Indian/Alaska Native, Asian, and Native Hawaiian/Pacific Islander children. The greater representation of Black/African American children compared with the US population suggests inclusive research practices that could be extended to other historically disenfranchised racial and ethnic groups.
Objective: Limited English proficiency (LEP) is a risk factor for health care inequity and an important focus for improving communication and care quality. This study examines the association between LEP and pediatric emergency department (ED) revisits.Methods: This was a retrospective, cross-sectional study of patients 0 to 21 years old discharged home after an initial visit from an academic, tertiary care pediatric ED from January 1, 2017, to June 30, 2018. We calculated rates of ED revisits within 72 h resulting in discharge or hospitalization and assessed rate differences between LEP and English-proficient (EP) patients. Multivariable logistic regression models examined the association between revisits and LEP status controlling for age, race, ethnicity, triage acuity, clinical complexity, and ED arrival time. Sensitivity models including insurance were also conducted.Results: There were 63,601 index visits in the study period; 12,986 (20%) were by patients with LEP. There were 2,387 (3.8%) revisits within 72 h of initial ED visit. Among LEP and EP patient visits, there were 4.53 and 3.55 revisits/100 initial ED visits, respectively (rate difference = 0.97, 95% confidence interval [CI] = 0.58 to 1.37). In the multivariable analyses, LEP was associated with increased odds of revisits resulting in discharge (odds ratio [OR] = 1.15, 95% CI = 1.01 to 1.30) and in hospitalization (OR = 1.28, 95% CI = 1.03 to 1.58). Sensitivity analyses additionally adjusting for insurance status attenuated these results.Conclusions: These results suggest that LEP was associated with increased pediatric ED revisits. Improved understanding of language barrier effects on clinical care is important for decreasing health care disparities in the ED.
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