title: Influence of race, clinical, and other socio-demographic features on trial participation.
abstract: 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).
authors.affiliation: Department of Social Medicine, Division of General Medicine and Clinical Epidemiology, University of North Carolina at Chapel Hill, Wing D, Medical School, CB#7240, Chapel Hill, NC 27599, USA. gcorbie@med.unc.edu
authors.forename: Giselle
authors.initials: G
authors.lastname: Corbie-Smith
authors.forename: Catherine M
authors.initials: CM
authors.lastname: Viscoli
authors.forename: Walter N
authors.initials: WN
authors.lastname: Kernan
authors.forename: Lawrence M
authors.initials: LM
authors.lastname: Brass
authors.forename: Philip
authors.initials: P
authors.lastname: Sarrel
authors.forename: Ralph I
authors.initials: RI
authors.lastname: Horwitz
mesh_terms: D000367:Age Factors; D000368:Aged; D001294:Attitude to Health; D004522:Educational Status; D015914:Estrogen Replacement Therapy; D005006:Ethnicity / Q000523:psychology*; D005260:Female; D006801:Humans; D007044:Hysterectomy / Q000706:statistics & numerical data; D007258:Informed Consent; D016015:Logistic Models; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D016017:Odds Ratio; D010358:Patient Participation; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic; D020521:Stroke / Q000208:ethnology / Q000517:prevention & control*