Dataset Information

Improving Enrollment of Underrepresented Racial and Ethnic Populations in Heart Failure Trials: A Call to Action From the Heart Failure Collaboratory.

ABSTRACT:

Importance

Despite bearing a disproportionate burden of heart failure (HF), Black and Hispanic individuals have been poorly represented in HF clinical trials. Underrepresentation in clinical trials limits the generalizability of the findings to these populations and may even introduce uncertainties and hesitancy when translating trial data to the care of people from underrepresented groups. The Heart Failure Collaboratory, a consortium of stakeholders convened to enhance HF therapeutic development, has been dedicated to improving recruitment strategies for patients from diverse and historically underrepresented groups.

Observations

Despite federal policies from the US Food and Drug Administration and National Institutes of Health aimed at improving trial representation, gaps in trial enrollment proportionate to the racial and ethnic composition of the HF population have persisted. Increasing trial globalization with limited US enrollment is a major driver of these patterns. Additional barriers to representative enrollment include inequities in care access, logistical issues in participation, restrictive enrollment criteria, and English language requirements.

Conclusions and relevance

Strategies for improving diverse trial enrollment include methodical study design and site selection, diversification of research leadership and staff, broadening of eligibility criteria, community and patient engagement, and broad stakeholder commitment. In contemporary HF trials, diverse trial enrollment is not only feasible but can be efficiently achieved to improve the generalizability and translation of trial knowledge to clinical practice.

SUBMITTER: DeFilippis EM

PROVIDER: S-EPMC9098689 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Improving Enrollment of Underrepresented Racial and Ethnic Populations in Heart Failure Trials: A Call to Action From the Heart Failure Collaboratory.

DeFilippis Ersilia M EM Echols Melvin M Adamson Philip B PB Batchelor Wayne B WB Cooper Lauren B LB Cooper Lawton S LS Desvigne-Nickens Patrice P George Richard T RT Ibrahim Nasrien E NE Jessup Mariell M Kitzman Dalane W DW Leifer Eric S ES Mendoza Martin M Piña Ileana L IL Psotka Mitchell M Senatore Fortunato Fred FF Stein Kenneth M KM Teerlink John R JR Yancy Clyde W CW Lindenfeld JoAnn J Fiuzat Mona M O'Connor Christopher M CM Vardeny Orly O Vaduganathan Muthiah M

JAMA cardiology 20220501 5

<h4>Importance</h4>Despite bearing a disproportionate burden of heart failure (HF), Black and Hispanic individuals have been poorly represented in HF clinical trials. Underrepresentation in clinical trials limits the generalizability of the findings to these populations and may even introduce uncertainties and hesitancy when translating trial data to the care of people from underrepresented groups. The Heart Failure Collaboratory, a consortium of stakeholders convened to enhance HF therapeutic d ...[more]

PMID: 35319725

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Project description:BackgroundDurable left ventricular assist devices (VADs) improve survival in eligible patients, but allocation has been associated with patient race in addition to presumed heart failure (HF) severity.ObjectivesThis study sought to determine racial and ethnic differences in VAD implantation rates and post-VAD survival among patients with ambulatory HF.MethodsUsing the INTERMACS (Interagency Registry of Mechanically Assisted Circulatory Support) database (2012-2017), this study examined census-adjusted VAD implantation rates by race, ethnicity, and sex in patients with ambulatory HF (INTERMACS profile 4-7) using negative binomial models with quadratic effect of time. Survival was evaluated using Kaplan-Meier estimates and Cox models adjusted for clinically relevant variables and an interaction of time with race/ethnicity.ResultsVADs were implanted in 2,256 adult patients with ambulatory HF (78.3% White, 16.4% Black, and 5.3% Hispanic). The median age at implantation was lowest in Black patients. Implantation rates peaked between 2013 and 2015 before declining in all demographic groups. From 2012 to 2017, implantation rates overlapped for Black and White patients but were lower for Hispanic patients. Post-VAD survival was significantly different among the 3 groups (log rank P = 0.0067), with higher estimated survival among Black vs White patients (12-month survival: Black patients: 90% [95% CI: 86%-93%]; White patients: 82% [95% CI: 80%-84%]). Low sample size for Hispanic patients resulted in imprecise survival estimates (12-month survival: 85% [95% CI: 76%-90%]).ConclusionsBlack and White patients with ambulatory HF had similar VAD implantation rates but rates were lower for Hispanic patients. Survival differed among the 3 groups, with the highest estimated survival at 12 months in Black patients. Given higher HF burden in minoritized populations, further investigation is needed to understand differences in VAD implantation rates in Black and Hispanic patients.

Project description:ImportanceRacial and ethnic disparities in clinical trial enrollment are unjust and hinder development of new cancer treatments.ObjectiveTo examine the association of race and ethnicity with clinical trial enrollment among women with endometrial, ovarian, or cervical cancer.Design, setting, and participantsThis retrospective cohort study used data from the National Cancer Database, a hospital-based cancer registry, and the Surveillance, Epidemiology, and End Results Program (SEER), a population-based cancer registry. Population-based race and ethnicity-specific proportions for each cancer site were derived from SEER. Participants included women with an endometrial, ovarian, or cervical cancer diagnosed from 2004 to 2019. Analyses were performed from February 2 to June 14, 2023.ExposureRace and ethnicity were categorized as American Indian/Alaska Native, Asian, Black, Hispanic (any race), Native Hawaiian/Pacific Islander, White, and other (not defined in the National Cancer Database).Main outcomes and measuresThe primary outcomes were the odds of clinical trial enrollment and representation in clinical trials compared with the US population. Multivariable-adjusted logistic regression was used to estimate odds ratios (ORs) and 95% CIs for associations of race and ethnicity with clinical trial enrollment within the National Cancer Database sample. Participation-to-prevalence ratios (PPRs) according to diagnosis period (2004-2011 vs 2012-2019) were calculated by dividing the race and ethnicity-specific percentage of clinical trial participants in the study sample by the percentage of racial and ethnic groups in SEER.ResultsAmong 562 592 patients with gynecologic cancer (mean [SD] age at diagnosis, 62.9 [11.3] years), 1903 were American Indian/Alaska Native, 18 680 were Asian, 56 421 were Black, 38 145 were Hispanic, 1453 were Native Hawaiian/Pacific Islander, 442 869 were White, and 3121 were other race and ethnicity. Only 548 (<1%) were enrolled in clinical trials. Compared with White women, clinical trial enrollment was lower for Asian (OR, 0.44; 95% CI, 0.25-0.78), Black (OR, 0.70; 95% CI, 0.50-0.99), and Hispanic (OR, 0.53; 95% CI, 0.33-0.83) women. Compared with the US population, White women were adequately or overrepresented for all cancer types (PPRs ≥1.1), Black women were adequately or overrepresented for endometrial and cervical cancers (PPRs ≥1.1) but underrepresented for ovarian cancer (PPR ≤0.6), and Asian and Hispanic women were underrepresented among all 3 cancer types (PPRs ≤0.6).Conclusions and relevanceIn this cohort of patients with gynecologic cancer, clinical trial enrollment was lower among certain minoritized racial and ethnic groups. Continued efforts are needed to address disparate clinical trial enrollment among underrepresented groups.

Project description:BackgroundThe differences in the incidence of heart failure by race/ethnicity and the potential mechanisms for these differences are largely unexplored in women.Methods and resultsA total of 156 143 postmenopausal women free of self-reported heart failure enrolled from 1993 to 1998 at 40 clinical centers throughout the United States as part of the Women's Health Initiative and were followed up until 2005, for an average of 7.8 years, for incident hospitalized heart failure. Incident rates, hazard ratios (HRs), and 95% confidence intervals were determined by use of the Cox proportional hazard model comparing racial/ethnic groups, and population-attributable risk percentages were calculated for each racial/ethnic group. Blacks had the highest age-adjusted incidence of heart failure (380 in 100 000 person-years), followed by whites (274), Hispanics (193), and Asian/Pacific Islanders (103). The excess risk in blacks compared with whites (age-adjusted HR=1.45) was significantly attenuated by adjustment for household income (HR=0.97) and diabetes mellitus (HR=0.89), but the lower risk in Hispanics (age-adjusted HR=0.72) and Asian/Pacific Islanders (age-adjusted HR=0.44) remained despite adjustment for traditional risk factors, socioeconomic status, lifestyle, and access-to-care variables. The effect of adjustment for interim coronary heart disease on nonwhite versus white HRs for heart failure differed by race/ethnic group.ConclusionsAsian/Pacific Islander and Hispanic women have a lower incidence of heart failure and black women have higher rates of heart failure compared with white women. The excess risk of incident heart failure in black women is explained largely by adjustment for lower household incomes and diabetes mellitus in black women, whereas the lower rates of heart failure in Asian/Pacific Islanders and Hispanics are largely unexplained by the risk factors measured in this study.Clinical trial registrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT00000611.

Dataset Information

Improving Enrollment of Underrepresented Racial and Ethnic Populations in Heart Failure Trials: A Call to Action From the Heart Failure Collaboratory.

Importance

Observations

Conclusions and relevance

Publications

Improving Enrollment of Underrepresented Racial and Ethnic Populations in Heart Failure Trials: A Call to Action From the Heart Failure Collaboratory.

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