title: Review of venous thromboembolism and race: the generalizability of treatment guidelines for high-risk populations.
abstract: The American College of Chest Physicians (ACCP) has established guidelines for the treatment of VTE, but the generalizability to all populations is unclear. In this review we analyzed the rate of reporting and enrollment of blacks and women in clinical trials cited in the ACCP guidelines for treatment of unprovoked VTE. We extracted data from clinical trials cited by the ACCP that compared durations of anticoagulation therapy for the treatment of unprovoked VTE. We excluded trials that treated surgical or cancer patients. For trials that did not report race/ethnicity we contacted the primary investigators via email for enrollment data. The final analysis included 17 randomized clinical trials with a total patient population of N = 13,693. All trials reported data on sex; conversely, 2 trials (11.8 %) reported race/ethnicity within the primary manuscript. We ultimately acquired data on race/ethnicity from the primary investigator in 5 additional trials for a total race/ethnicity data from 7 trials. There were 7573 males (55.3 %) and 6120 females (44.7 %) enrolled in these studies. Among trials that reported race and ethnicity the total patient population was N = 5368; 5171 (96.3 %) white, 115 (2.1 %) black, 65 (1.4 %) Asian and 7 (0.25 %) Hispanic. Racial/ethnic minorities are underreported and under represented in clinical trials forming the cornerstone of ACCP guidelines for the optimal duration for VTE treatment. Conversely, the reporting and inclusion of women was substantive. The guidelines for unprovoked VTE treatment may not be generalizable to racially and ethnically diverse patient populations.
authors.affiliation: Duke Clinical Research Institute, Duke University Department of Medicine, 2400 Pratt Street, Durham, NC, 27705, USA.
authors.forename: Lonnie T
authors.initials: LT
authors.lastname: Sullivan
authors.affiliation: Duke Clinical Research Institute, Duke University Department of Medicine, 2400 Pratt Street, Durham, NC, 27705, USA.
authors.forename: Larry R
authors.initials: LR
authors.lastname: Jackson
authors.affiliation: Duke Clinical Research Institute, Duke University Department of Medicine, 2400 Pratt Street, Durham, NC, 27705, USA. kevin.thomas@duke.edu.
authors.forename: Kevin L
authors.initials: KL
authors.lastname: Thomas
mesh_terms: D005006:Ethnicity / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D008297:Male; D017410:Practice Guidelines as Topic / Q000592:standards*; D012307:Risk Factors; D012737:Sex Factors; D054556:Venous Thromboembolism / Q000208:ethnology*
keywords: Black; Enrollment; Ethnicity; Venous thromboembolism