4.6 Article

Influence of race, clinical, and other socio-demographic features on trial participation

Journal

JOURNAL OF CLINICAL EPIDEMIOLOGY
Volume 56, Issue 4, Pages 304-309

Publisher

PERGAMON-ELSEVIER SCIENCE LTD
DOI: 10.1016/S0895-4356(03)00046-5

Keywords

race; clinical features; socio-demographic features; trial participation

Funding

  1. NHLBI NIH HHS [K01 HL 04039] Funding Source: Medline
  2. NINDS NIH HHS [NS 31251] Funding Source: Medline

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We assessed whether sociodemographic and clinical characteristics were determinants of clinical trial participation in the Women's Estrogen for Stroke Trial (WEST) by examining data collected on women with a WEST consent visit completed after June 1996. We found no differences in consent rates by education or ethnic group (32% of white women compared with 34% of black women). Conditions associated with the intervention, such as a history of hysterectomy or previous estrogen replacement use, were strongly associated with a woman's decision to participate in this clinical trial. In multivariate models, features independently associated with consent to participate were age (odds ratio [OR] 0.96, 95% confidence interval [CI] 0.94-0.97), hysterectomy (OR 1.78, 95% CI 1.27-2.50), no cognitive impairment (OR 1.70, 95% CI 1.10-2.63), history of volunteerism (OR 1.62, 95% CI 1.02-2.63), and previous estrogen use (RR 1.58, 95% CI 1.08-2.30). (C) 2003 Elsevier Inc. All rights reserved.

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