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Efforts Needed to Foster Participation of Blacks in Stroke Studies

Efforts Needed to Foster Participation of Blacks in Stroke Studies San Diego—Blacks are disproportionately affected by stroke and researchers do not fully understand why. That a better understanding of why blacks are more likely to experience and die of stroke is needed is underscored by sobering figures on the impact of the disease on the black community. But getting the answers requires a concerted effort to recruit black participants in stroke research—an effort stymied, in part, by a clash of cultures between historically "ivory tower" researchers and a subject population leery of being experimented upon . The risk of stroke is higher in blacks than in whites in the United States. This racial disparity for stroke risk is especially pronounced for those under age 65 years. Black men experience stroke at the rate of 87 per 100 --nbsp entity reference inserted-->000 vs 59 per 100 000 for white men, according to the American Heart Association; among black women, the incidence of stroke is 78 per 100 000 vs 58 per 100 000 for white women. Blacks younger than 65 years have a two- to four-fold greater risk of ischemic stroke compared with their white counterparts. Blacks also are more likely to die of stroke and develop hypertension earlier in life with greater severity than whites. Studies suggest that the disparity is caused by a variety of physiological, socioeconomic, and cultural factors, but the research community has been slow to embrace research that will better define those factors. Although the National Institutes of Health mandated in 1993 that the clinical research it funds should include proportionate representation of patients by racial and ethnic group, most studies involving stroke research have enrolled too few blacks to obtain definitive clinical answers. But this situation is finally changing. Just last year, researchers published the first major multicenter, randomized prospective, clinical trial that tried to answer clinical questions specifically regarding blacks and stroke (JAMA. 2003;289:2947-2957). At the American Stroke Association's International Stroke Conference held in San Diego last month, researchers from that groundbreaking study, the African American Antiplatelet Stroke Prevention Study (AAASPS), were spreading the word to their colleagues about how to conduct such trials involving blacks. "The fact is that African Americans are at a higher risk for stroke, and yet treatment recommendations are based largely on studies involving few African Americans," said DeJuran Richardson, PhD, head statistician for the AAASPS and the director of data management for the Center for Stroke Research at the University of Illinois College of Medicine in Chicago. The trial, which sought to determine the efficacy and safety of ticlopidine compared with aspirin to prevent recurrent stroke in blacks, demonstrated the problem with making treatment decisions based on an analysis of a small subset of subjects. The AAASPS investigators proposed such a study because subset analysis of another trial, the Ticlopidine Aspirin Stroke Study (TASS), suggested ticlopidine was more beneficial for nonwhites than whites (Neurology.1993;43:27-31). In the subset analysis, which involved 603 nonwhite participants (including 495 blacks) out of a total of 3069 total trial participants given ticlopidine (500 mg/d) or aspirin (1300 mg/d), the researchers found a 24.1% reduction in risk of stroke and death at 2 years with ticlopidine relative to aspirin. The randomized, double-blind, multicenter AAASPS trial, which enrolled 1809 black men and women who had a noncardioembolic ischemic stroke, came to a different conclusion. Participants received 500 mg/d of ticlopidine or 650 mg/d of aspirin and were followed for up to 2 years. The researchers discovered that there was no statistically significant difference between ticlopidine and aspirin in the prevention of recurrent stroke, myocardial infarction, or vascular death—in fact, there was a nonsignificant trend for reduction of stroke among those participants taking aspirin. "The key message is that aspirin turned out as good, or better, in preventing a recurrent stroke," said Philip B. Gorelick, MD, lead author of AAASPS and head of the Department of Neurology and Rehabilitation at the University of Illinois College of Medicine. "This demonstrated the importance of not looking at subanalysis from other studies with inadequate numbers of patients to make conclusions." The successful recruitment of 1809 blacks into the AAASPS study did not come easy, and some wondered if such a trial could be conducted at all. "When we submitted our proposal there was a lot of skepticism," Richardson said. "People said we couldn't enroll these patients, and even if we did, they'd drop out. But that didn't happen. It's all about working with the community. We learned this in cancer and HIV research. If you're going to conduct research in a community, you have to work with the community." But to do so meant the researchers needed to overcome barriers. "Many people in the community are economically strapped, and we needed to devise means of overcoming that barrier," Gorelick said. To surmount economic hurdles, the AAASPS investigators conducted home visits or offered travel stipends for participants to reach the study hospitals. "We also had to overcome the barrier related to communications and the trappings of mistrust which began in the pre-Civil War period, was reinforced with the Tuskegee [syphilis study], and continues today," Gorelick explained. In the Tuskegee study, which examined the natural history of the disease, black participants were not told they had syphilis and were denied treatment even after penicillin became available in the late 1940s. The incident fostered mistrust in the black community about participation in medical research. While the AAASPS study was being designed, discussions with participants about their feelings toward recruitment into clinical trials helped ease the mistrust, Gorelick said. Sensitivity training for AAASPS investigators also helped ease a potential communications gap. "This trial opens the door for many other focused studies in high-risk groups," Gorelick said. "We showed you can recruit and get answers in a reasonable amount of time." He said his team has discussed the AAASPS mechanics with investigators around the country to help them "jump start" their studies. Sean Ruland, DO, a neurologist at the University of Illinois and a coinvestigator on the AAASPS trial, offered his view of what made the trial successful. On home visits, "we'd bend over backwards to insure that people would understand that we were working for their best interests," he said. There's no magic to reproducing what we did," said Ruland. "You just have to put your nose to the grindstone." Haircuts and Hypertension: Barbers Enlisted to Screen for High Blood Pressure Haircuts and Hypertension: Barbers Enlisted to Screen for High Blood Pressure At some Dallas barbershops in the black community, a shave and a haircut may no longer cost two bits, but the blood pressure screening is free. Haircuts and Hypertension: Barbers Enlisted to Screen for High Blood Pressure As part of an attempt to raise awareness among black men to the dangers associated with hypertension, stroke, and cardiovascular disease, barbers at several shops are being trained to measure the blood pressure of their customers and discuss the results. The Red Bird barbershop staff cuts hair and screens blood pressure. (Photo credit: University of Texas Southwestern Medical Center at Dallas) Haircuts and Hypertension: Barbers Enlisted to Screen for High Blood Pressure The effort is part of a pilot study by researchers from the University of Texas-Southwestern Medical Center in Dallas to determine if this unorthodox method reaches a population that is generally unaware of the increased risk for hypertension-related diseases and conditions among blacks. The study was funded by grants from the Texas Higher Education Coordinating Board, the Aetna Foundation, and Pfizer Inc. Haircuts and Hypertension: Barbers Enlisted to Screen for High Blood Pressure The study's principal investigator, Ronald Victor, MD, said he and colleagues designed the project to effectively reach the population that has the greatest burden of premature cardiovascular morbidity and mortality due to untreated and uncontrolled hypertension—black men. Haircuts and Hypertension: Barbers Enlisted to Screen for High Blood Pressure "The conventional public health approach is a lot of work that has produced a lot of disappointing results," said Victor, codirector of the Donald W. Reynolds Cardiovascular Clinical Research Center at University of Texas-Southwestern. "We asked a number of lay and professional people where we could go to find a large number of African-American men." Haircuts and Hypertension: Barbers Enlisted to Screen for High Blood Pressure The answer: the barbershop. "It's the social and cultural epicenter of urban life for many black men," he said. Haircuts and Hypertension: Barbers Enlisted to Screen for High Blood Pressure The barbers are being trained to measure blood pressure using automated devices. Customers with untreated hypertension are then referred for medical treatment. Haircuts and Hypertension: Barbers Enlisted to Screen for High Blood Pressure The Dallas effort is not the first to use the barbershop setting to screen black men for hypertension. Victor noted other demonstration projects in New Orleans and Baltimore showed the barbers and customers were supportive of the screening. Haircuts and Hypertension: Barbers Enlisted to Screen for High Blood Pressure The Dallas researchers are planning a second phase of the project to see if the intervention actually translates into results. They hope to enlist more shops and train more barbers to create a trial with enough power to determine whether such screening programs result in black men seeking treatment for hypertension and reducing their blood pressure, Victor said. Haircuts and Hypertension: Barbers Enlisted to Screen for High Blood Pressure "Our idea is to make the barbers blood-pressure specialists and motivate customers to seek treatment," Victor said. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

Efforts Needed to Foster Participation of Blacks in Stroke Studies

JAMA , Volume 291 (11) – Mar 17, 2004

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Publisher
American Medical Association
Copyright
Copyright © 2004 American Medical Association. All Rights Reserved.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.291.11.1311
Publisher site
See Article on Publisher Site

Abstract

San Diego—Blacks are disproportionately affected by stroke and researchers do not fully understand why. That a better understanding of why blacks are more likely to experience and die of stroke is needed is underscored by sobering figures on the impact of the disease on the black community. But getting the answers requires a concerted effort to recruit black participants in stroke research—an effort stymied, in part, by a clash of cultures between historically "ivory tower" researchers and a subject population leery of being experimented upon . The risk of stroke is higher in blacks than in whites in the United States. This racial disparity for stroke risk is especially pronounced for those under age 65 years. Black men experience stroke at the rate of 87 per 100 --nbsp entity reference inserted-->000 vs 59 per 100 000 for white men, according to the American Heart Association; among black women, the incidence of stroke is 78 per 100 000 vs 58 per 100 000 for white women. Blacks younger than 65 years have a two- to four-fold greater risk of ischemic stroke compared with their white counterparts. Blacks also are more likely to die of stroke and develop hypertension earlier in life with greater severity than whites. Studies suggest that the disparity is caused by a variety of physiological, socioeconomic, and cultural factors, but the research community has been slow to embrace research that will better define those factors. Although the National Institutes of Health mandated in 1993 that the clinical research it funds should include proportionate representation of patients by racial and ethnic group, most studies involving stroke research have enrolled too few blacks to obtain definitive clinical answers. But this situation is finally changing. Just last year, researchers published the first major multicenter, randomized prospective, clinical trial that tried to answer clinical questions specifically regarding blacks and stroke (JAMA. 2003;289:2947-2957). At the American Stroke Association's International Stroke Conference held in San Diego last month, researchers from that groundbreaking study, the African American Antiplatelet Stroke Prevention Study (AAASPS), were spreading the word to their colleagues about how to conduct such trials involving blacks. "The fact is that African Americans are at a higher risk for stroke, and yet treatment recommendations are based largely on studies involving few African Americans," said DeJuran Richardson, PhD, head statistician for the AAASPS and the director of data management for the Center for Stroke Research at the University of Illinois College of Medicine in Chicago. The trial, which sought to determine the efficacy and safety of ticlopidine compared with aspirin to prevent recurrent stroke in blacks, demonstrated the problem with making treatment decisions based on an analysis of a small subset of subjects. The AAASPS investigators proposed such a study because subset analysis of another trial, the Ticlopidine Aspirin Stroke Study (TASS), suggested ticlopidine was more beneficial for nonwhites than whites (Neurology.1993;43:27-31). In the subset analysis, which involved 603 nonwhite participants (including 495 blacks) out of a total of 3069 total trial participants given ticlopidine (500 mg/d) or aspirin (1300 mg/d), the researchers found a 24.1% reduction in risk of stroke and death at 2 years with ticlopidine relative to aspirin. The randomized, double-blind, multicenter AAASPS trial, which enrolled 1809 black men and women who had a noncardioembolic ischemic stroke, came to a different conclusion. Participants received 500 mg/d of ticlopidine or 650 mg/d of aspirin and were followed for up to 2 years. The researchers discovered that there was no statistically significant difference between ticlopidine and aspirin in the prevention of recurrent stroke, myocardial infarction, or vascular death—in fact, there was a nonsignificant trend for reduction of stroke among those participants taking aspirin. "The key message is that aspirin turned out as good, or better, in preventing a recurrent stroke," said Philip B. Gorelick, MD, lead author of AAASPS and head of the Department of Neurology and Rehabilitation at the University of Illinois College of Medicine. "This demonstrated the importance of not looking at subanalysis from other studies with inadequate numbers of patients to make conclusions." The successful recruitment of 1809 blacks into the AAASPS study did not come easy, and some wondered if such a trial could be conducted at all. "When we submitted our proposal there was a lot of skepticism," Richardson said. "People said we couldn't enroll these patients, and even if we did, they'd drop out. But that didn't happen. It's all about working with the community. We learned this in cancer and HIV research. If you're going to conduct research in a community, you have to work with the community." But to do so meant the researchers needed to overcome barriers. "Many people in the community are economically strapped, and we needed to devise means of overcoming that barrier," Gorelick said. To surmount economic hurdles, the AAASPS investigators conducted home visits or offered travel stipends for participants to reach the study hospitals. "We also had to overcome the barrier related to communications and the trappings of mistrust which began in the pre-Civil War period, was reinforced with the Tuskegee [syphilis study], and continues today," Gorelick explained. In the Tuskegee study, which examined the natural history of the disease, black participants were not told they had syphilis and were denied treatment even after penicillin became available in the late 1940s. The incident fostered mistrust in the black community about participation in medical research. While the AAASPS study was being designed, discussions with participants about their feelings toward recruitment into clinical trials helped ease the mistrust, Gorelick said. Sensitivity training for AAASPS investigators also helped ease a potential communications gap. "This trial opens the door for many other focused studies in high-risk groups," Gorelick said. "We showed you can recruit and get answers in a reasonable amount of time." He said his team has discussed the AAASPS mechanics with investigators around the country to help them "jump start" their studies. Sean Ruland, DO, a neurologist at the University of Illinois and a coinvestigator on the AAASPS trial, offered his view of what made the trial successful. On home visits, "we'd bend over backwards to insure that people would understand that we were working for their best interests," he said. There's no magic to reproducing what we did," said Ruland. "You just have to put your nose to the grindstone." Haircuts and Hypertension: Barbers Enlisted to Screen for High Blood Pressure Haircuts and Hypertension: Barbers Enlisted to Screen for High Blood Pressure At some Dallas barbershops in the black community, a shave and a haircut may no longer cost two bits, but the blood pressure screening is free. Haircuts and Hypertension: Barbers Enlisted to Screen for High Blood Pressure As part of an attempt to raise awareness among black men to the dangers associated with hypertension, stroke, and cardiovascular disease, barbers at several shops are being trained to measure the blood pressure of their customers and discuss the results. The Red Bird barbershop staff cuts hair and screens blood pressure. (Photo credit: University of Texas Southwestern Medical Center at Dallas) Haircuts and Hypertension: Barbers Enlisted to Screen for High Blood Pressure The effort is part of a pilot study by researchers from the University of Texas-Southwestern Medical Center in Dallas to determine if this unorthodox method reaches a population that is generally unaware of the increased risk for hypertension-related diseases and conditions among blacks. The study was funded by grants from the Texas Higher Education Coordinating Board, the Aetna Foundation, and Pfizer Inc. Haircuts and Hypertension: Barbers Enlisted to Screen for High Blood Pressure The study's principal investigator, Ronald Victor, MD, said he and colleagues designed the project to effectively reach the population that has the greatest burden of premature cardiovascular morbidity and mortality due to untreated and uncontrolled hypertension—black men. Haircuts and Hypertension: Barbers Enlisted to Screen for High Blood Pressure "The conventional public health approach is a lot of work that has produced a lot of disappointing results," said Victor, codirector of the Donald W. Reynolds Cardiovascular Clinical Research Center at University of Texas-Southwestern. "We asked a number of lay and professional people where we could go to find a large number of African-American men." Haircuts and Hypertension: Barbers Enlisted to Screen for High Blood Pressure The answer: the barbershop. "It's the social and cultural epicenter of urban life for many black men," he said. Haircuts and Hypertension: Barbers Enlisted to Screen for High Blood Pressure The barbers are being trained to measure blood pressure using automated devices. Customers with untreated hypertension are then referred for medical treatment. Haircuts and Hypertension: Barbers Enlisted to Screen for High Blood Pressure The Dallas effort is not the first to use the barbershop setting to screen black men for hypertension. Victor noted other demonstration projects in New Orleans and Baltimore showed the barbers and customers were supportive of the screening. Haircuts and Hypertension: Barbers Enlisted to Screen for High Blood Pressure The Dallas researchers are planning a second phase of the project to see if the intervention actually translates into results. They hope to enlist more shops and train more barbers to create a trial with enough power to determine whether such screening programs result in black men seeking treatment for hypertension and reducing their blood pressure, Victor said. Haircuts and Hypertension: Barbers Enlisted to Screen for High Blood Pressure "Our idea is to make the barbers blood-pressure specialists and motivate customers to seek treatment," Victor said.

Journal

JAMAAmerican Medical Association

Published: Mar 17, 2004

Keywords: ischemic stroke,blacks

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