Clinical Investigation
Acute Ischemic Heart Disease
Reporting and representation of ethnic minorities in cardiovascular trials: A systematic review

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Background

Ethnic minority groups in the United States are at increased risk of developing cardiovascular diseases, experiencing adverse outcomes, and receiving suboptimal treatment. Such discrepancies may be related to a difference in race-specific outcomes in the management of cardiovascular diseases. However, little is known about the reporting and representation of ethnic minorities in major cardiovascular trials.

Methods

A systematic review of major cardiovascular randomized controlled trials published in The Journal of the American Medical Association, The Lancet, and The New England Journal of Medicine between 1997 and 2010 was performed. We determined the reporting rate of the following ethnic minority groups in studies that enrolled American patients: whites, African Americans, Asians, and Hispanics.

Results

A total of 250 randomized controlled trials that enrolled 1,103,694 patients were included in the systematic review. Among them, 56% (n = 140) of the trials reported information on race. No significant temporal changes in racial reporting were observed during the study period (P = .21). The median enrollment rate in trials for whites, African Americans, Hispanics, and Asians was 86%, 7%, 6%, and 4%, respectively. When compared with the population prevalence of disease burden, we found that whites were overrepresented (88% vs 78%, P < .001), whereas African Americans were underrepresented (3% vs 11%, P < .001), in trials of coronary artery disease.

Conclusions

Despite significant changes in the ethnic composition of the United States, we found that only about half of all major cardiovascular trials reported any racial information. Underrepresentation of ethnic minority groups in cardiovascular trials was observed.

Section snippets

Study selection

Our systematic review included studies published in The Journal of the American Medical Association (JAMA), The Lancet, and The New England Journal of Medicine (NEJM). These 3 medical journals were chosen because they have the highest impact factors and have been reported to have the most significant influence on clinical practice. This methodology of focusing on the highest impact journals was also consistent with several prior studies.10, 11 A standardized protocol was used for study

Results

A total of 250 major cardiovascular randomized clinical trials were included in our systematic review from 1997 to 2010 with recruitments of Americans. The attrition diagram for our literature search is shown in Figure 1. A total of 1,103,694 participants were enrolled in these trials. The mean age of the study participants was 63 years, and 35% were female. The majority of trials enrolled patients with coronary artery disease (58%) and evaluated drugs as an intervention (68%) (Table I).

Discussion

Our current systematic review of major contemporary cardiovascular trials extends previous findings of studies of racial representation in cardiovascular research. First, although we observed some improvements in the reporting of minority ethnic groups from 1997 to 2010, only about half of all studies reported any racial information of the enrolled patients. Second, we observed underenrollment of minority ethnic groups; but enrollment appeared to differ by ethnic groups in cardiovascular

Disclosures

Funding sources: Dr Ko is supported by a New Investigator Award from the Canadian Institutes of Health Research.

No conflicts of interest.

Acknowledgements

We are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the paper, and its final contents.

Role of the sponsors

The results and conclusions are those of the authors and should not be attributed to any of the funding or sponsoring agencies. All decisions regarding study design, publication, and data analysis were made independent of the funding agencies.

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