4.8 Article

Prospective, Multicenter, Controlled Trial of Mobile Stroke Units

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NEW ENGLAND JOURNAL OF MEDICINE
卷 385, 期 11, 页码 971-981

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MASSACHUSETTS MEDICAL SOC
DOI: 10.1056/NEJMoa2103879

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In patients eligible for t-PA, mobile stroke units (MSUs) showed better functional outcomes at 90 days compared to emergency medical services (EMS). Patients in the MSU group were more likely to achieve a modified Rankin scale score of 0 or 1 at 90 days.
Background Mobile stroke units (MSUs) are ambulances with staff and a computed tomographic scanner that may enable faster treatment with tissue plasminogen activator (t-PA) than standard management by emergency medical services (EMS). Whether and how much MSUs alter outcomes has not been extensively studied. Methods In an observational, prospective, multicenter, alternating-week trial, we assessed outcomes from MSU or EMS management within 4.5 hours after onset of acute stroke symptoms. The primary outcome was the score on the utility-weighted modified Rankin scale (range, 0 to 1, with higher scores indicating better outcomes according to a patient value system, derived from scores on the modified Rankin scale of 0 to 6, with higher scores indicating more disability). The main analysis involved dichotomized scores on the utility-weighted modified Rankin scale (>= 0.91 or <0.91, approximating scores on the modified Rankin scale of <= 1 or >1) at 90 days in patients eligible for t-PA. Analyses were also performed in all enrolled patients. Results We enrolled 1515 patients, of whom 1047 were eligible to receive t-PA; 617 received care by MSU and 430 by EMS. The median time from onset of stroke to administration of t-PA was 72 minutes in the MSU group and 108 minutes in the EMS group. Of patients eligible for t-PA, 97.1% in the MSU group received t-PA, as compared with 79.5% in the EMS group. The mean score on the utility-weighted modified Rankin scale at 90 days in patients eligible for t-PA was 0.72 in the MSU group and 0.66 in the EMS group (adjusted odds ratio for a score of >= 0.91, 2.43; 95% confidence interval [CI], 1.75 to 3.36; P<0.001). Among the patients eligible for t-PA, 55.0% in the MSU group and 44.4% in the EMS group had a score of 0 or 1 on the modified Rankin scale at 90 days. Among all enrolled patients, the mean score on the utility-weighted modified Rankin scale at discharge was 0.57 in the MSU group and 0.51 in the EMS group (adjusted odds ratio for a score of >= 0.91, 1.82; 95% CI, 1.39 to 2.37; P<0.001). Secondary clinical outcomes generally favored MSUs. Mortality at 90 days was 8.9% in the MSU group and 11.9% in the EMS group. Conclusions In patients with acute stroke who were eligible for t-PA, utility-weighted disability outcomes at 90 days were better with MSUs than with EMS. (Funded by the Patient-Centered Outcomes Research Institute; BEST-MSU ClinicalTrials.gov number, .) Trial of Mobile Stroke Units Mobile stroke units have CT scanners and personnel trained to administer tissue plasminogen activator. In a multicity trial, functional outcomes at 90 days after acute stroke were better with mobile stroke units than with standard care by emergency medical services and transfer to an emergency department.

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