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Objective To determine whether aspirin and antioxidant therapy, combined or alone, are more effective than placebo in reducing the development of cardiovascular events in patients with diabetes mellitus and asymptomatic peripheral arterial disease.Design Multicentre, randomised, double blind, 2×2 factorial, placebo controlled trial.Setting 16 hospital centres in Scotland, supported by 188 primary care groups.Participants 1276 adults aged 40 or more with type 1 or type 2 diabetes and an ankle brachial pressure index of 0.99 or less but no symptomatic cardiovascular disease.Interventions Daily, 100 mg aspirin tablet plus antioxidant capsule (n=320), aspirin tablet plus placebo capsule (n=318), placebo tablet plus antioxidant capsule (n=320), or placebo tablet plus placebo capsule (n=318).Main outcome measures Two hierarchical composite primary end points of death from coronary heart disease or stroke, non-fatal myocardial infarction or stroke, or amputation above the ankle for critical limb ischaemia; and death from coronary heart disease or stroke.Results No evidence was found of any interaction between aspirin and antioxidant. Overall, 116 of 638 primary events occurred in the aspirin groups compared with 117 of 638 in the no aspirin groups (18.2% v 18.3%): hazard ratio 0.98 (95% confidence interval 0.76 to 1.26). Forty three deaths from coronary heart disease or stroke occurred in the aspirin groups compared with 35 in the no aspirin groups (6.7% v 5.5%): 1.23 (0.79 to 1.93). Among the antioxidant groups 117 of 640 (18.3%) primary events occurred compared with 116 of 636 (18.2%) in the no antioxidant groups (1.03, 0.79 to 1.33). Forty two (6.6%) deaths from coronary heart disease or stroke occurred in the antioxidant groups compared with 36 (5.7%) in the no antioxidant groups (1.21, 0.78 to 1.89).Conclusion This trial does not provide evidence to support the use of aspirin or antioxidants in primary prevention of cardiovascular events and mortality in the population with diabetes studied.Trial registration Current Controlled Trials ISRCTN53295293.

Previous studies predicting functional outcomes of stroke have mainly used clinical and demographic measures. This study examines the additional predictive value of psychological predictors. A cohort of patients were assessed on 6 occasions between admission to hospital and 3 years post-stroke, with 40 of the original sample of 101 being available at the final assessment. Demographic variables, clinical indexes, and psychological measures were used to predict survival to 3 years and 3-year functional recovery was assessed using measures derived from the Barthel Index which took account of initial levels of performance. For functional recovery, multiple regression analyses showed that fixed clinical and demographic indexes explained 16% to 40% of the variance in recovery. Perceptions of control 6 months after discharge added significantly to the predictive equations. Because these cognitions are modifiable, they offer opportunities for intervention to improve patient outcomes. Multiple regression showed that no psychological variables predicted survival.