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Background and Purpose: Fewer women than men tend to be enrolled in clinical trials of intracerebral hemorrhage. It is unclear whether this reflects lower prevalence of intracerebral hemorrhage in women, selection bias, or poor recruitment efforts. We undertook this study to examine differences between men and women in the reasons for exclusion from the iDEF trial (Intracerebral Hemorrhage Deferoxamine). Methods: The screen failure log included 29 different reasons for exclusion. Chi-square statistics were used to evaluate the differences in reasons for exclusion between men and women. Results: A total of 38.2% of participants in iDEF were women. Three thousand nine hundred eighty-two women (45.7%) and 4736 men (54.3%) were screen failures ( P P =0.1). Patients or families declined participation in 1.26% of women versus 1.31% of men ( P =0.9). More women than men failed screening because of age>80 (22.40% versus 12.61%; adjusted P =0.0007) and preexisting do-not-resuscitate/do-not-intubate (3.69% versus 2.83%; adjusted P =0.067). Conclusions: Lower rates of women enrollment in the iDEF trial may be attributed to older age. Inability to obtain consent or declining participation was similar between women and men, arguing against selection bias. Our findings should be confirmed in other intracerebral hemorrhage trials to determine best strategies to improve women’s representation in future trials.

Background&Purpose: There are limited diet regarding the potential association of adherence to Mediterranean Diet (MeD) with incident stroke. We sought to determine longitudinally the relationship between higher adherence to Mediterranean diet and lower likelihood of incident stroke before and after controlling for factors that are independently related to cerebrovascular disease burden by capitalizing on the large, geographically dispersed, race- and gender-balanced sample of REGARDS subjects. Subjects&Methods: A prospective, population-based, cohort of individuals enrolled in REGARDS Study was evaluated after excluding participants with history of stroke and missing data with respect to demographic, cognitive or food intake variables. Adherence to a MeD was computed from Food Frequency Questionnaires (FFQ) and was categorized as high, moderate and low using MeD-score tertiles (MeD-score: 6-9, 4-5 & 0-3 respectively). The main outcome of the present analyses was incident stroke that had been diagnosed by a committee of trained clinicians during a mean follow-up period of 5 years. The association of adherence to MeD with incident stroke (ischemic and hemorrhagic) was evaluated using a set of incremental logistic regression models. Results: Incident stroke was identified in 565 (1.9%; 497 cases of ischemic and 68 cases of hemorrhagic stroke) out of 30,239 individuals fulfilling the inclusion criteria. After adjusting for age, race, region, gender, income, education, total energy, smoking status, sedentary behavior, body mass index, waist circumference and vascular risk factors, low adherence to MeD was associated with a higher likelihood of incident ischemic stroke (OR versus high adherence: 1.29; 95%CI:0.99-1.67; p=0.057). A similar relationship was documented for moderate adherence to MeD (OR versus high adherence: 1.25; 95%CI:0.98-1.58; p=0.079). We documented no association of adherence to MeD with incident hemorrhagic stroke (p=0.38). There was no interaction of race (p=0.38) on the association of adherence to MeD with incident ischemic stroke. Conclusions: Low adherence to MeD was associated with a higher likelihood of incident ischemic stroke independent of numerous potential confounders.

Background and Purpose— Black/white disparities in stroke incidence are well documented, but few studies have assessed the contributions to the disparity. Here we assess the contribution of “traditional” risk factors. Methods— A total of 25 714 black and white men and women, aged ≥45 years and stroke-free at baseline, were followed for an average of 4.4 years to detect stroke. Mediation analysis using proportional hazards analysis assessed the contribution of traditional risk factors to racial disparities. Results— At age 45 years, incident stroke risk was 2.90 (95% CI: 1.72–4.89) times more likely in blacks than in whites and 1.66 (95% CI: 1.34–2.07) times at age 65 years. Adjustment for risk factors attenuated these excesses by 40% and 45%, respectively, resulting in relative risks of 2.14 (95% CI: 1.25–3.67) and 1.35 (95% CI: 1.08–1.71). Approximately one half of this mediation is attributable to systolic blood pressure. Further adjustment for socioeconomic factors resulted in total mediation of 47% and 53% to relative risks of 2.01 (95% CI: 1.16–3.47) and 1.30 (1.03–1.65), respectively. Conclusions— Between ages 45 to 65 years, approximately half of the racial disparity in stroke risk is attributable to traditional risk factors (primarily systolic blood pressure) and socioeconomic factors, suggesting a critical need to understand the disparity in the development of these traditional risk factors. Because half of the excess stroke risk in blacks is not attributable to traditional risk factors and socioeconomic factors, differential impact of risk factors, residual confounding, or nontraditional risk factors may also play a role.