Nerses Sanossian1, Lauren Rosenberg2, David S Liebeskind2, Sidney Starkman2, Marc Eckstein2, Samuel Stratton2, Franklin D Pratt2, Scott Hamilton2, May Kim-Tenser2, Latisha K Sharma2, Lucas Restrepo2, Miguel Valdes-Suieras2, Robin Conwit2, Jeffrey L Saver2. 1. From the Departments of Neurology (N.S., L.R., M.K.-T.) and Emergency Medicine (M.E.), University of Southern California, Los Angeles; UCLA Stroke Center, Los Angeles, CA (D.S.L., S.S., L.K.S., L.R., M.V.-S., J.L.S.); School of Public Health, University of California Los Angeles (S.S.); Los Angeles County Fire Department, CA (F.D.P.); Stanford University, CA (S.H.); and National Institutes of Health, Bethesda, MD (R.C.). sanossia@yahoo.com. 2. From the Departments of Neurology (N.S., L.R., M.K.-T.) and Emergency Medicine (M.E.), University of Southern California, Los Angeles; UCLA Stroke Center, Los Angeles, CA (D.S.L., S.S., L.K.S., L.R., M.V.-S., J.L.S.); School of Public Health, University of California Los Angeles (S.S.); Los Angeles County Fire Department, CA (F.D.P.); Stanford University, CA (S.H.); and National Institutes of Health, Bethesda, MD (R.C.).
Abstract
BACKGROUND AND PURPOSE: Novel methods are needed to reduce the disparity of Hispanic enrollment in stroke clinical trials. Prehospital enrollment using a dedicated Spanish language line may help overcome this bias. METHODS: Subjects or legally authorized representatives provided information on race and ethnicity for all cases enrolled in the FAST-MAG clinical trial (Field Administration of Stroke Therapy-Magnesium), a prehospital phase 3 randomized study of intravenous magnesium for neuroprotection. One of 2 in-ambulance cell phones (in English or Spanish) was used to obtain informed content in the field. We describe the yield and characteristics of subjects enrolled via Spanish line. RESULTS: There were 1700 subjects enrolled from 2005 to 2012, of which 402 (24%) identified as Hispanic ethnicity. Study racial makeup was 1325 (78%) white, 219 (13%) black, and 139 (8%) Asian. The dedicated Spanish line was used for 195 (12%) enrollments. Spanish-line enrollments were younger (65 versus 70 years old; P<0.001), more likely to identify as Hispanic (98% versus 14%; P<0.001), and more likely to present with intracerebral hemorrhage (36% versus 21%; P<0.001). CONCLUSIONS: The use of a dedicated Spanish language enrollment line allowed for greater enrollment of Hispanics, a population with significantly different baseline characteristics. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00059332.
RCT Entities:
BACKGROUND AND PURPOSE: Novel methods are needed to reduce the disparity of Hispanic enrollment in stroke clinical trials. Prehospital enrollment using a dedicated Spanish language line may help overcome this bias. METHODS: Subjects or legally authorized representatives provided information on race and ethnicity for all cases enrolled in the FAST-MAG clinical trial (Field Administration of Stroke Therapy-Magnesium), a prehospital phase 3 randomized study of intravenous magnesium for neuroprotection. One of 2 in-ambulance cell phones (in English or Spanish) was used to obtain informed content in the field. We describe the yield and characteristics of subjects enrolled via Spanish line. RESULTS: There were 1700 subjects enrolled from 2005 to 2012, of which 402 (24%) identified as Hispanic ethnicity. Study racial makeup was 1325 (78%) white, 219 (13%) black, and 139 (8%) Asian. The dedicated Spanish line was used for 195 (12%) enrollments. Spanish-line enrollments were younger (65 versus 70 years old; P<0.001), more likely to identify as Hispanic (98% versus 14%; P<0.001), and more likely to present with intracerebral hemorrhage (36% versus 21%; P<0.001). CONCLUSIONS: The use of a dedicated Spanish language enrollment line allowed for greater enrollment of Hispanics, a population with significantly different baseline characteristics. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00059332.