In:
Circulation, Ovid Technologies (Wolters Kluwer Health), Vol. 142, No. Suppl_3 ( 2020-11-17)
Abstract:
Introduction: Racial/ethnic diversity in clinical trials is essential to ensure that our evidence base reflects the population. We assessed the extent of reporting and representation of race/ethnicity in heart failure (HF) clinical trials referenced in the contemporary ACC/AHA HF guidelines. Methods: All randomized trials referenced in the 2013 ACC/AHA Heart Failure Guidelines and the 2017 Focused Update were included. The prevalence of reporting of race/ethnicity, the proportions of racial/ethnic subgroups enrolled, and subgroup analysis based on intervention type - pharmacologic, device, and other - were evaluated. Results: We identified 256 trials (545 233 subjects) published between 1950 and 2018. Among these, only 95 reported any race/ethnicity (37.1%), 94 reported white race (36.7%), 58 reported black race (22.7%), 16 reported Hispanic ethnicity (6.3%), and 23 reported Asian race (9.0%). In trials reporting white, black, Hispanic, and Asian race/ethnicity respectively, 76.4% (n = 299 153 of 299872) of patients were white, 11.7% (n = 25 274 of 215 905) of patients were black, 11.2% (n = of 8863 of 79 097) of patients were Hispanic, and 10.5% (n = 14925 of 141 504) of patients were Asian. Comparison of trial population proportions with US Census population demonstrates over-representation of white subjects, and under-representation of Hispanic and black subjects (Figure). Stratification by intervention type demonstrated that no device trials referenced in the guidelines report black or Asian race, and just one reported Hispanic race. Conclusions: Trials that dictate clinical care of patients with HF through informing contemporary ACC/AHA HF guidelines under-represent black and Hispanic populations. Additionally, 2/3rds of trials fail to report any race/ ethnicity at all. There is a need for guideline and practice-informing clinical trials to adequately represent all populations, and to provide clinicians the data they need to assess generalizability.
Type of Medium:
Online Resource
ISSN:
0009-7322
,
1524-4539
DOI:
10.1161/circ.142.suppl_3.17339
Language:
English
Publisher:
Ovid Technologies (Wolters Kluwer Health)
Publication Date:
2020
detail.hit.zdb_id:
1466401-X
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