Should data monitoring committees assess efficacy when considering safety in trails in acute stroke?

The primary role of a trials Data Monitoring Committee (DMC) is to ensure the safety of enrolled patients. In stroke trials, safety is monitored typically by comparing death and stroke specific events between treatment groups. DMCs may also have the remit for monitoring efficacy depending on the aims of the trial. We hypothesised that functional outcome at end of follow-up, a measure of efficacy, is also a powerful measure of safety and tested this in a systematic review

Rail passenger crowding, stress, health and safety in Britain

There has long been a question as to whether crowding in rail passenger transport poses a threat to passenger health related to the experience of stress. A review of the scientific literature was conducted. Little rail-specific empirical research was identified. The more general research that does exist suggests that high-density environments are not necessarily perceived as crowded and that stress-related physiological, psychological and behavioural reactions do not necessarily follow from exposure to such environments. Several factors are identified that may moderate the impact of a high-density environment on perceptions of crowding and the subsequent experience and effects of stress. These include, inter alia, perceptions of control and predictability of events. However, if caused, the experience and effects of stress may be made worse by inadequate coach design that gives rise to discomfort. The model that emerges from these findings offers a suitable framework for the development of research questions that should help translate emerging knowledge into practical interventions, for the reduction of any adverse health outcomes associated with crowding.

Speeding stroke recovery? A systematic review of amphetamine after stroke

Introduction: The use of drugs to enhance recovery (“rehabilitation pharmacology”) has been assessed. Amphetamine can improve outcome in experimental models of stroke, and several small clinical trials have assessed its use in stroke. Methods: Electronic searches were performed to identify randomised controlled trials of amphetamine in stroke (ischaemic or haemorrhagic). Outcomes included functional outcome (assessed as combined death or disability/dependency), safety (death) and haemodynamic measures. Data were analysed as dichotomous or continuous outcomes, using odds ratios (OR), weighted or standardised mean difference, (WMD or SMD) using random-effects models with 95% confidence intervals (95% CI); statistical heterogeneity was assessed. Results: Eleven completed trials (n=329) were identified. Treatment with amphetamine was associated with non-significant trends to increased death (OR 2.78 (95% CI, 0.75– 10.23), n=329, 11 trials) and improved motor scores (WMD 3.28 (95% CI −0.48–7.04) n=257, 9 trials) but had no effect on the combined outcome of death and dependency (OR 1.15 (95% CI 0.65–2.06, n=206, 5 trials). Amphetamine increased systolic blood pressure (WMD 9.3 mmHg, 95% CI 3.3–15.3, n=106, 3 trials) and heart rate (WMD 7.6 beats per minute (bpm), 95% CI 1.8–13.4, n=106, 3 trials). Despite variations in treatment regimes, outcomes and follow-up duration there was no evidence of significant heterogeneity or publication bias. Conclusion: No evidence exists at present to support the use of amphetamine after stroke. Despite a trend to improved motor function, doubts remain over