Background: Endpoints that are commonly used in trials of moderate/severe stroke may be less frequent in patients with minor, non-disabling stroke thus inflating sample sizes. We tested whether trial efficiency might be improved with composite endpoints. Methods: We prospectively recruited patients with lacunar and minor non-lacunar ischaemic stroke (NIHSS /= 3 and 29/158 (19%) had ACE-R /= 3 alone would require n > 5000 participants, recurrent vascular events alone n = 9908 participants, and a composite of any recurrent vascular event, ACE-R /= 2 (present in 56% of patients) n = 2224 patients. However, including cognition increased missing data. Results were similar for lacunar and non-lacunar minor ischaemic stroke. Conclusions: Composite outcomes including vascular events, dependency, and cognition reduce sample size and increase efficiency, feasibility, and relevance to patients of RCTs in minor ischaemic stroke. Efficiency might be improved further with more practical cognitive test strategies.
|Number of pages||8|
|Journal||European Stroke Journal|
|Early online date||5 Sep 2017|
|Publication status||Published - 2018|
- Stroke cognition dependency
- lacunar outcome
- power calculation
- randomised trial sample size
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- School of Medicine, Medical Sciences & Nutrition, Applied Health Sciences - Senior Lecturer (Clinical)
Person: Clinical Academic