Under-representation of women and ethnic minorities in vascular surgery randomized controlled trials
Presented at the Thirty-sixth Annual Symposium of the Society for Clinical Vascular Surgery, Las Vegas, Nev, Mar 5-8, 2008.
Received 18 October 2008; accepted 7 January 2009.
Objectives
Gender and ethnicity are factors affecting the incidence and severity of vascular disease as well as subsequent treatment outcomes. Although well studied in other fields, balanced enrollment of patients with relevant demographic characteristics in vascular surgery randomized controlled trials (RCTs) is not well known. This study describes the reporting of gender and ethnicity data in vascular surgery RCTs and analyzes whether these studies adequately represent our diverse patient population.
Methods
We conducted a retrospective review of United States-based RCTs from 1983 through 2007 for three broadly defined vascular procedures: aortic aneurysm repair (AAR), carotid revascularization (CR), and lower extremity revascularization (LER). Included studies were examined for gender and ethnicity data, study parameters, funding source, and geographic region. The Nationwide Inpatient Sample (NIS) database was analyzed to obtain group-specific procedure frequency as an estimate of procedure frequency in the general population.
Results
We reviewed 77 studies, and 52 met our inclusion criteria. Only 85% reported gender, and 21% reported ethnicity. Reporting of ethnicity was strongly associated with larger (>280 participants), multicenter, government-funded trials (P < .001 for all). Women are disproportionately under-represented in RCTs for all procedure categories (AAR, 9.0% vs 21.5%; CR, 30.0% vs 42.9%; LER, 22.4% vs 41.3%). Minorities are under-represented in AAR studies (6.0% vs 10.7%) and CR studies (6.9% vs 9.5%) but are over-represented in LER studies (26.0% vs 21.8%, P < .001 for all).
Conclusions
Minority ethnicity and female gender are under-reported and under-represented in vascular surgery RCTs, particularly in small, non-government-funded and single-center trials. The generalizability of some trial results may not be applicable to these populations. Greater effort to enroll a balanced study population in RCTs may yield more broadly applicable results.
aDivision of Vascular Surgery, Brigham & Women's Hospital, Boston, Mass
bDepartment of Surgery, University of Massachusetts Medical Center, Worchester, Mass
cDivision of Vascular Surgery, University of California San Francisco Medical Center, San Francisco, Calif
dCenter for Surgery & Public Health, Brigham & Women's Hospital, Boston, Mass
Correspondence: Louis L. Nguyen, MD, MBA, MPH, Division of Vascular & Endovascular Surgery and the Center for Surgery & Public Health, Brigham & Women's Hospital, 75 Francis St, Boston, MA 02115
This work was supported by a National Institutes of Health (NIH) K23 Research Career Development Award (HL084386) to Dr Nguyen.
Competition of interest: none.
Additional material for this article may be found online at www.jvascsurg.org.
ABSTRACT