Factors Associated with Racial and Ethnic Diversity among Heart Failure Trial Participants: A Systematic Bibliometric Review

Background: Heart failure has a disproportionate burden on patients who are Black, Indigenous, and people of color (BIPOC), but not much is known about representation of these groups in randomized controlled trials (RCTs). We explored temporal trends in and RCT factors associated with the reporting of race and ethnicity data and the enrollment of BIPOC in heart failure RCTs. Methods: We searched MEDLINE, EMBASE, and CINAHL for heart failure RCTs published in journals with an impact factor ≥10 between January 1, 2000 and June 17, 2020. We used the Cochran-Armitage and Jonchkeere-Terpstra tests to examine temporal trends, and multivariable regression to assess the association between trial characteristics and outcomes. Results: Of 414 RCTs meeting inclusion criteria, only 157 (37.9% [95% CI, 33.2%-2.8%]) reported race and ethnicity data. Among 158 200 participants in these 157 RCTs, 29 512 (18.7% [95% CI, 18.5%-18.9%]) were BIPOC. There was a temporal increase in reporting of race and ethnicity data (29.5% in 2000-2003 to 54.7% in 2016-2020, P<0.001) and in enrollment of BIPOC (14.4% in 2000-2003 to 22.2% in 2016-2020, P=0.038). Trial leadership by a woman was independently associated with twice the odds of reporting race and ethnicity data (odds ratio, 2.0 [95% CI, 1.1-3.8]; P=0.028) and an 8.4% increase (95% CI, 1.9%-15.0%; P=0.013) in BIPOC enrollment. Conclusions: A minority of heart failure RCTs reported race and ethnicity data, and among these, BIPOC were under-enrolled relative to disease distribution. Both reporting of race and ethnicity as well as enrollment of BIPOC increased between 2000 and 2020. After multivariable adjustment, trials led by women had greater odds of reporting race and ethnicity and enrolling BIPOC. Registration: URL: https://www.crd.york.ac.uk/PROSPERO/; Unique identifier: CRD42021237497.