Objective To determine the effects of low dose aspirin on cognitive function in middle aged to elderly men and women at moderately increased cardiovascular risk.
Design Randomised double blind placebo controlled trial.
Setting Central Scotland.
Participants 3350 men and women aged over 50 participating in the aspirin for asymptomatic atherosclerosis trial.
Intervention Low dose aspirin (100 mg daily) or placebo for five years.
Main outcome measures Tests of memory, executive function, non-verbal reasoning, mental flexibility, and information processing five years after randomisation, with scores used to create a summary cognitive score (general factor).
Results At baseline, mean vocabulary scores (an indicator of previous cognitive ability) were similar in the aspirin (30.9, SD 4.7) and placebo (31.1, SD 4.7) groups. In the primary intention to treat analysis, there was no significant difference at follow-up between the groups in the proportion achieving over the median general factor cognitive score (32.7% and 34.8% respectively, odds ratio 0.91, 95% confidence interval 0.79 to 1.05, P=0.20) or in mean scores on the individual cognitive tests. There were also no significant differences in change in cognitive ability over the five years in a subset of 504 who underwent detailed cognitive testing at baseline.
Conclusion Low dose aspirin does not affect cognitive function in middle aged to elderly people at increased cardiovascular risk.
Trial registration ISRCTN 66587262.
Objective To compare the effectiveness and safety of three types of stents (sirolimus eluting, paclitaxel eluting, and bare metal) in people with and without diabetes mellitus.
Design Collaborative network meta-analysis.
Data sources Electronic databases (Medline, Embase, the Cochrane Central Register of Controlled Trials), relevant websites, reference lists, conference abstracts, reviews, book chapters, and proceedings of advisory panels for the US Food and Drug Administration. Manufacturers and trialists provided additional data.
Review methods Network meta-analysis with a mixed treatment comparison method to combine direct within trial comparisons between stents with indirect evidence from other trials while maintaining randomisation. Overall mortality was the primary safety end point, target lesion revascularisation the effectiveness end point.
Results 35 trials in 3852 people with diabetes and 10 947 people without diabetes contributed to the analyses. Inconsistency of the network was substantial for overall mortality in people with diabetes and seemed to be related to the duration of dual antiplatelet therapy (P value for interaction 0.02). Restricting the analysis to trials with a duration of dual antiplatelet therapy of six months or more, inconsistency was reduced considerably and hazard ratios for overall mortality were near one for all comparisons in people with diabetes: sirolimus eluting stents compared with bare metal stents 0.88 (95% credibility interval 0.55 to 1.30), paclitaxel eluting stents compared with bare metal stents 0.91 (0.60 to 1.38), and sirolimus eluting stents compared with paclitaxel eluting stents 0.95 (0.63 to 1.43). In people without diabetes, hazard ratios were unaffected by the restriction. Both drug eluting stents were associated with a decrease in revascularisation rates compared with bare metal stents in people both with and without diabetes.
Conclusion In trials that specified a duration of dual antiplatelet therapy of six months or more after stent implantation, drug eluting stents seemed safe and effective in people both with and without diabetes.
Objectives To investigate the association between use of typical and atypical antipsychotic drugs and incidence of stroke in patients with and without dementia.
Design Self controlled case series.
Setting UK based electronic primary care records in the general practice research database (GPRD).
Participants All patients registered in the database with a recorded incident stroke and at least one prescription for any antipsychotic drug before the end of 2002: 6790 eligible participants were identified and included in the final analysis.
Main outcome measures Rate ratio for stroke in periods of time exposed to antipsychotics compared with unexposed periods.
Results Use of any antipsychotic drug was associated with a rate ratio for stroke of 1.73 (95% confidence interval 1.60 to 1.87): 1.69 (1.55 to 1.84) for typical antipsychotics and 2.32 (1.73 to 3.10) for atypical antipsychotics. In patients receiving any antipsychotic drug, the rate ratios were 3.50 (2.97 to 4.12) for those with dementia and 1.41 (1.29 to 1.55) for those without dementia.
Conclusions All antipsychotics are associated with an increased risk of stroke, and the risk might be higher in patients receiving atypical antipsychotics than those receiving typical antipsychotics. People with dementia seem to be at a higher risk of an associated stroke than people without dementia and use of antipsychotics should, when possible, be avoided in these patients.
Objective To determine if a complex nursing and midwifery intervention in hospital labour assessment units would increase the likelihood of spontaneous vaginal birth and improve other maternal and neonatal outcomes.
Design Multicentre, randomised controlled trial with prognostic stratification by hospital.
Setting 20 North American and UK hospitals.
Participants 5002 nulliparous women experiencing contractions but not in active labour; 2501 were allocated to structured care and 2501 to usual care.
Interventions Usual nursing or midwifery care or a minimum of one hour of care by a nurse or midwife trained in structured care, consisting of a formalised approach to assessment of and interventions for maternal emotional state, pain, and fetal position.
Main outcome measures Primary outcome was spontaneous vaginal birth. Other outcomes included intrapartum interventions, women’s views of their care, and indicators of maternal and fetal health during hospital stay and 6-8 weeks after discharge.
Results Outcome data were obtained for 4996 women. The rate of spontaneous vaginal birth was 64.0% (n=1597) in the structured care group and 61.3% (n=1533) in the usual care group (odds ratio 1.12, 95% confidence interval 0.96 to 1.27). Fewer women allocated to structured care (n=403, 19.5%) rated staff helpfulness as less than very helpful than those allocated to usual care (n=544, 26.4%); odds ratio 0.67, 98.75% confidence interval 0.50 to 0.85. Fewer women allocated to structured care (n=233, 11.3%) were disappointed with the amount of attention received from staff than those allocated to usual care (n=407, 19.7%); odds ratio 0.51, 98.75% confidence interval 0.32 to 0.70. None of the other results met prespecified levels of statistical significance.
Conclusion A structured approach to care in hospital labour assessment units increased satisfaction with care and was suggestive of a modest increase in the likelihood of spontaneous vaginal birth. Further study to strengthen the intervention is warranted.
Trial registration Current Controlled Trials ISRCTN16315180.