Background: Large numbers of stroke patients arrive at hospital at a very early stage, and effective treatments for the acute phase of the disease are available. However, evidence that patients with acute stroke benefit from stroke-unit care is scarce. Our aim was to determine whether admission to a stroke unit, rather than a conventional ward, affected the outcome of patients with acute stroke. Methods: We did an observational follow-up study of 11 572 acute stroke patients hospitalised within 48 h of the onset of symptoms either in a stroke unit (n=4936) or in a conventional ward (6636). Patients were identified retrospectively from discharge records from 260 Italian hospitals. The primary outcome was mortality or disability (Rankin score greater than two), assessed prospectively by independent, masked assessors 2 years after admission. Analyses were adjusted for patient characteristics and clustered at the hospital level. Findings: Overall, 1576 patients died in hospital; 2169 died during the follow-up period. 347 patients were lost to follow-up. Compared with conventional-ward care, stroke-unit care was associated with a reduced probability of death or being disabled at the end of follow-up (odds ratio 0·81, 95% CI 0·72-0·91; p=0·0001). The potential benefit was significant across all age ranges and clinical characteristics, except for unconsciousness. No specific elements of setting, organisation, or process of care were associated with outcome. Interpretation: Admission to a stroke-unit ward with dedicated beds and staff within 48 h of onset should be recommended for all patients with acute stroke.
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