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Racial and Ethnic Enrollment Disparities and Demographic Reporting Requirements in Acute Leukemia Clinical Trials.

ABSTRACT: Data regarding racial and ethnic enrollment diversity for acute myeloid (AML) and lymphoid leukemia (ALL) clinical trials in the United States (US) are limited, and little is known about the effect of federal reporting requirements instituted in the late 2000s. We examined demographic data reporting and enrollment diversity for US ALL and AML trials from 2002-2017 as well as changes in reporting and diversity after reporting requirements were instituted. Of 223 AML and 97 ALL trials with results, 68 (30.5%) and 51 (52.6%) reported enrollment by both race and ethnicity. Among trials that reported race and ethnicity (AML N=6,554; ALL N=4,149), non-Hispanic (NH)-Black, NH-Native American, NH-Asian, and Hispanic patients had significantly lower enrollment compared to NH-white patients after adjusting for race-ethnic disease incidence (AML odds: 0.68, 0.31, 0.75, and 0.83; ALL: 0.74, 0.27, 0.67, and 0.64; all p≤0.01). The proportion of trials reporting race increased significantly after the reporting requirements (44.2 to 60.2%; p=0.02), but race-ethnicity reporting did not (34.8 to 38.6%; p=0.57). Reporting proportions by number of patients enrolled increased significantly after the reporting requirements (race: 51.7 to 72.7%, race-ethnicity: 39.5 to 45.4%; both p<0.001), and relative enrollment of NH-Black and Hispanic patients decreased (AML odds: 0.79 and 0.77; ALL: 0.35 and 0.25; both p≤0.01). These data suggest that demographic enrollment reporting for acute leukemia trials is suboptimal, changes in diversity after the reporting requirements may be due to additional enrollment disparities that were previously unreported, and enrollment diversification strategies specific to acute leukemia care delivery are needed.

SUBMITTER: Hantel A

PROVIDER: S-EPMC8579250 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:PurposePrevious work has shown that asthma-related emergency department (ED) use is greatest among Black and Latine populations, but it is unknown whether health care use for exacerbations differs across settings (outpatient, ED, inpatient) and correlates with use of routine outpatient services. We aimed to measure disparities by race, ethnicity, and language in pediatric acute asthma care using data from US primary care community health centers.MethodsIn an observational study using electronic health records from community health centers in 18 states, we compared non-Hispanic Black, English-preferring Latine, Spanish-preferring Latine, and non-Hispanic White children aged 3 to 17 years on visits for clinic-coded asthma exacerbations (2012-2018). We further evaluated asthma-related ED use and inpatient admissions in a subsample of Oregon-Medicaid recipients. Covariate-adjusted odds ratios (ORs) and rate ratios (RRs) were derived using logistic or negative binomial regression analysis with generalized estimating equations.ResultsAmong 41,276 children with asthma, Spanish-preferring Latine children had higher odds of clinic visits for asthma exacerbation than non-Hispanic White peers (OR = 1.10; 95% CI, 1.02-1.18). Among the subsample of 6,555 children insured under Oregon-Medicaid, non-Hispanic Black children had higher odds and rates of asthma-related ED use than non-Hispanic White peers (OR = 1.40; 95% CI, 1.04-1.89 and RR = 1.49; 95% CI, 1.09-2.04, respectively). We observed no differences between groups in asthma-related inpatient admissions.ConclusionsThis study is the first to show that patterns of clinic and ED acute-care use differ for non-Hispanic Black and Spanish-preferring Latine children when compared with non-Hispanic White peers. Non-Hispanic Black children had lower use of clinics, whereas Spanish-preferring Latine children had higher use, including for acute exacerbations. These patterns of clinic use were accompanied by higher ED use among Black children. Ensuring adequate care in clinics may be important in mitigating disparities in asthma outcomes.VISUAL ABSTRACT.

Project description:Racial-ethnic disparities in acute stroke care can contribute to inequality in stroke outcomes. We examined race-ethnic disparities in acute stroke performance metrics in a voluntary stroke registry among Florida and Puerto Rico Get With the Guidelines-Stroke hospitals.Seventy-five sites in the Florida Puerto Rico Stroke Registry (66 Florida and 9 Puerto Rico) recorded 58 864 ischemic stroke cases (2010-2014). Logistic regression models examined racial-ethnic differences in acute stroke performance measures and defect-free care (intravenous tissue plasminogen activator treatment, in-hospital antithrombotic therapy, deep vein thrombosis prophylaxis, discharge antithrombotic therapy, appropriate anticoagulation therapy, statin use, smoking cessation counseling) and temporal trends. Among ischemic stroke cases, 63% were non-Hispanic white (NHW), 18% were non-Hispanic black (NHB), 14% were Hispanic living in Florida, and 6% were Hispanic living in Puerto Rico. NHW patients were the oldest, followed by Hispanics, and NHBs. Defect-free care was greatest among NHBs (81%), followed by NHWs (79%) and Florida Hispanics (79%), then Puerto Rico Hispanics (57%) (P<0.0001). Puerto Rico Hispanics were less likely than Florida whites to meet any stroke care performance metric other than anticoagulation. Defect-free care improved for all groups during 2010-2014, but the disparity in Puerto Rico persisted (2010: NHWs=63%, NHBs=65%, Florida Hispanics=59%, Puerto Rico Hispanics=31%; 2014: NHWs=93%, NHBs=94%, Florida Hispanics=94%, Puerto Rico Hispanics=63%).Racial-ethnic/geographic disparities were observed for acute stroke care performance metrics. Adoption of a quality improvement program improved stroke care from 2010 to 2014 in Puerto Rico and all Florida racial-ethnic groups. However, stroke care quality delivered in Puerto Rico is lower than in Florida. Sustained support of evidence-based acute stroke quality improvement programs is required to improve stroke care and minimize racial-ethnic disparities, particularly in resource-strained Puerto Rico.

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Racial and Ethnic Enrollment Disparities and Demographic Reporting Requirements in Acute Leukemia Clinical Trials.

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