Stroke Units, Tissue Plasminogen Activator, Aspirin and Neuroprotection: Which Stroke Intervention Could Provide the Greatest Community Benefit?

Gilligan, Amanda; Thrift, Amanda G.; Sturm, Jonathan; Dewey, Helen M; Macdonell, Richard; Donnan, Geoffrey A.

doi:10.1159/000087705

Cited by 88 publications

(53 citation statements)

References 29 publications

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“…7 Among these interventions, the stroke unit effect has potentially the greatest population impact as it combines both moderate effectiveness and broad applicability. 1,2 However, as it is a complex intervention it is difficult to be certain about the key components of stroke unit care. 8 Descriptive studies have reported that early mobilisation (EM) (starting out of bed, sitting, standing and walking early after stroke) is widely thought to be an important contributor to the stroke unit effect.…”

Section: Chapter 1 Introductionmentioning

confidence: 99%

A Very Early Rehabilitation Trial after stroke (AVERT): a Phase III, multicentre, randomised controlled trial

Langhorne

Rodgers

et al. 2017

Health Technol Assess

134

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BackgroundMobilising patients early after stroke [early mobilisation (EM)] is thought to contribute to the beneficial effects of stroke unit care but it is poorly defined and lacks direct evidence of benefit.ObjectivesWe assessed the effectiveness of frequent higher dose very early mobilisation (VEM) after stroke.DesignWe conducted a parallel-group, single-blind, prospective randomised controlled trial with blinded end-point assessment using a web-based computer-generated stratified randomisation.SettingThe trial took place in 56 acute stroke units in five countries.ParticipantsWe included adult patients with a first or recurrent stroke who met physiological inclusion criteria.InterventionsPatients received either usual stroke unit care (UC) or UC plus VEM commencing within 24 hours of stroke.Main outcome measuresThe primary outcome was good recovery [modified Rankin scale (mRS) score of 0–2] 3 months after stroke. Secondary outcomes at 3 months were the mRS, time to achieve walking 50 m, serious adverse events, quality of life (QoL) and costs at 12 months. Tertiary outcomes included a dose–response analysis.Data sourcesPatients, outcome assessors and investigators involved in the trial were blinded to treatment allocation.ResultsWe recruited 2104 (UK,n = 610; Australasia,n = 1494) patients: 1054 allocated to VEM and 1050 to UC. Intervention protocol targets were achieved. Compared with UC, VEM patients mobilised 4.8 hours [95% confidence interval (CI) 4.1 to 5.7 hours;p < 0.0001] earlier, with an additional three (95% CI 3.0 to 3.5;p < 0.0001) mobilisation sessions per day. Fewer patients in the VEM group (n = 480, 46%) had a favourable outcome than in the UC group (n = 525, 50%) (adjusted odds ratio 0.73, 95% CI 0.59 to 0.90;p = 0.004). Results were consistent between Australasian and UK settings. There were no statistically significant differences in secondary outcomes at 3 months and QoL at 12 months. Dose–response analysis found a consistent pattern of an improved odds of efficacy and safety outcomes in association with increased daily frequency of out-of-bed sessions but a reduced odds with an increased amount of mobilisation (minutes per day).LimitationsUC clinicians started mobilisation earlier each year altering the context of the trial. Other potential confounding factors included staff patient interaction.ConclusionsPatients in the VEM group were mobilised earlier and with a higher dose of therapy than those in the UC group, which was already early. This VEM protocol was associated with reduced odds of favourable outcome at 3 months cautioning against very early high-dose mobilisation. At 12 months, health-related QoL was similar regardless of group. Shorter, more frequent mobilisation early after stroke may be associated with a more favourable outcome.Future workThese results informed a new trial proposal [A Very Early Rehabilitation Trial – DOSE (AVERT–DOSE)] aiming to determine the optimal frequency and dose of EM.Trial registrationThe trial is registered with the Australian New Zealand Clinical Trials Registry number ACTRN12606000185561, Current Controlled Trials ISRCTN98129255 and ISRCTN98129255.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 21, No. 54. See the NIHR Journals Library website for further project information. Funding was also received from the National Health and Medical Research Council Australia, Singapore Health, Chest Heart and Stroke Scotland, Northern Ireland Chest Heart and Stroke, and the Stroke Association. In addition, National Health and Medical Research Council fellowship funding was provided to Julie Bernhardt (1058635), who also received fellowship funding from the Australia Research Council (0991086) and the National Heart Foundation (G04M1571). The Florey Institute of Neuroscience and Mental Health, which hosted the trial, acknowledges the support received from the Victorian Government via the Operational Infrastructure Support Scheme.

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Section: Chapter 1 Introductionmentioning

confidence: 99%

A Very Early Rehabilitation Trial after stroke (AVERT): a Phase III, multicentre, randomised controlled trial

Langhorne

Rodgers

et al. 2017

Health Technol Assess

134

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“…Currently, evidence-based treatments, such as thrombolysis within 3 hours, aspirin, and admission to stroke units, are more commonly used for patients with acute stroke. [26][27][28][29][30] Our study shows that the proportion of patients with ischemic stroke receiving thrombolytic treatment significantly increased from 1.4% to 3.9% after the intervention in the intervention communities. Moreover, more patients with stroke received antithrombotic and lipidlowering agents at postintervention.…”

Section: Discussionmentioning

confidence: 83%

Community-Based Stroke System of Care for Chinese Rural Areas

Wang

Gong

et al. 2014

Stroke

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Background and Purpose— Stroke system of care plays key roles both in providing effective therapies and in improving the overall outcome of patients with stroke. Our purpose was to develop and evaluate the system in Chinese rural areas. Methods— A stroke system of care was developed from November 2009 to November 2010 in 3 townships in Ganyu County. An additional 3 matched townships were invited as controls. We first investigated stroke management in these townships and then implemented stroke system of care and an education campaign in the 3 intervention townships. The effectiveness of the system was then evaluated. Results— There were 1036 patients with new stroke among 344 345 subjects in the 6 rural communities. The incidence of stroke in the rural areas was 301/100 000, and the mortality rate was 55/100 000. The proportions significantly increased in the intervention communities after the implementation of the stroke system of care and education campaign when compared with the control communities, including patients presenting at rural hospitals within 3 hours of symptom onset (13.6% versus 8.7%; P =0.017), diagnosed by computed tomographic scanning within 24 hours of admission (65.3% versus 58.5%; P =0.034), and received thrombolytic treatment (3.9% versus 1.7%; P =0.038). During the 1-year follow-up, 32 (6.5%) patients with stroke in the intervention communities and 48 (10.1%) in the control communities died. The disability rate of stroke was significantly reduced in the intervention communities at postintervention (38.4% versus 48.1%; P =0.001). Conclusions— A stroke system of care would be reliable and practical in Chinese rural areas. Clinical Trial Registration— URL: http://www.chictr.org . Unique identifier: ChiCTR-RCH-13003408.

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“…Stroke patients should be treated in stroke unit [10][11][12][33][34][35][36] , since recent studies have supported the effectiveness of stroke units and management in a stroke rehabilitation unit confers survival benefits 10 years after stroke, probably because long-term survival is related to early reduction in disability 35 . An estimate based on data obtained from the North East Melbourne Stroke Incidence Study showed that although t-PA was the most potent intervention, the management in stroke units had the greatest population benefit 36 .…”

Section: Stroke Unitsmentioning

confidence: 99%

“…An estimate based on data obtained from the North East Melbourne Stroke Incidence Study showed that although t-PA was the most potent intervention, the management in stroke units had the greatest population benefit 36 . Stroke unit care, as provided in routine clinical practice in United Kingdom 37 and Sweden [38][39][40] , is associated with reduced case fatality by up to 25%, and reduction in mortality by 46% compared with general ward treatment 41 .…”

Section: Stroke Unitsmentioning

confidence: 99%