Inclusion of Under-represented Racial and Ethnic Minorities in Randomized Clinical Trials for Inflammatory Bowel Disease

Cohen, Nathaniel A.; Silfen, Alexa; Rubin, David T.

doi:10.1053/j.gastro.2021.09.035

Cited by 20 publications

(5 citation statements)

References 18 publications

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“…Population subgroups that face health disparities are often underrepresented in clinical research, including clinical trials [1][2][3][4]. The bias introduced by underrepresentation of certain populations in randomized controlled trials (RCTs) can result in the inability to apply trial findings to the underrepresented patient subgroups.…”

Section: Health Disparities In the Usmentioning

confidence: 99%

Assessing ascertainment bias in atrial fibrillation across US minority groups

Hulstaert,

Boehme,

Hood

et al. 2024

PLoS ONE

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The aim of this study is to define atrial fibrillation (AF) prevalence and incidence rates across minority groups in the United States (US), to aid in diversity enrollment target setting for randomized controlled trials. In AF, US minority groups have lower clinically detected prevalence compared to the non-Hispanic or Latino White (NHW) population. We assess the impact of ascertainment bias on AF prevalence estimates. We analyzed data from adults in Optum’s de-identified Clinformatics® Data Mart Database from 2017–2020 in a cohort study. Presence of AF at baseline was identified from inpatient and/or outpatient encounters claims using validated ICD-10-CM diagnosis algorithms. AF incidence and prevalence rates were determined both in the overall population, as well as in a population with a recent stroke event, where monitoring for AF is assumed. Differences in prevalence across cohorts were assessed to determine if ascertainment bias contributes to the variation in AF prevalence across US minority groups. The period prevalence was respectively 4.9%, 3.2%, 2.1% and 5.9% in the Black or African American, Asian, Hispanic or Latino, and NHW population. In patients with recent ischemic stroke, the proportion with AF was 32.2%, 24.3%, 25%, and 24.5%, respectively. The prevalence of AF among the stroke population was approximately 7 to 10 times higher than the prevalence among the overall population for the Asian and Hispanic or Latino population, compared to approximately 5 times higher for NHW patients. The relative AF prevalence difference of the Asian and Hispanic or Latino population with the NHW population narrowed from respectively, -46% and -65%, to -22% and -24%. The study findings align with previous observational studies, revealing lower incidence and prevalence rates of AF in US minority groups. Prevalence estimates of the adult population, when routine clinical practice is assumed, exhibit higher prevalence differences compared to settings in which monitoring for AF is assumed, particularly among Asian and Hispanic or Latino subgroups.

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Section: Health Disparities In the Usmentioning

confidence: 99%

Assessing ascertainment bias in atrial fibrillation across US minority groups

Hulstaert,

Boehme,

Hood

et al. 2024

PLoS ONE

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“…121 The general population can include paediatric, elderly, or pregnant patients, and those with or at increased risk of comorbidities such as infection, cancer, or cardiovascular disease, and certain ethnic groups. 122 Furthermore, there is variability in the background risk of infection worldwide, meaning that decisions around the cost-benefit of immunosuppression, in particular, will differ. In a cross-sectional study within the IBD Partners cohort reported by Johnson et al (2020), only 7•6% of patients from a total of 14,747 patients with IBD reported RCT participation at any time.…”

Section: Limitations Of Randomized Controlled Trialsmentioning

confidence: 99%

The cost of inflammatory bowel disease in high-income settings: a Lancet Gastroenterology & Hepatology Commission

Burisch

Zhao

Odes

et al. 2023

The Lancet Gastroenterology & Hepatology

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“…Studies by Cohen et al 6 and Sedano et al 7 highlighted the presence of racial and ethnic minority group disparities in IBD clinical trials. In this study, we similarly demonstrated that reported numbers of racial and ethnic minority participants in IBD clinical trials fell below US Census percentages for some groups (Figure 1B).…”

Section: Inclusion Of Racial and Ethnic Minority Participantsmentioning

confidence: 99%

“…4,5 These important calls to action highlight the need to understand the makeup of clinical trial participants in inflammatory bowel disease (IBD) studies. Studies by Cohen et al 6 and Sedano et al 7 identified under-representation in inclusion of participants from racial and ethnic minority groups. However, these studies did not focus on the inclusion of women or older individuals-2 groups also identified as at risk for being understudied.…”

mentioning

confidence: 99%