I would be concerned basing any decisions based on this trial because the selection choice seems to be based on a psychological profile. This is too easy to manipulate the expected outcomes. Poor candidates can easily be screened out.
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2815%2960690-0/abstract
The AVERT Trial Collaboration group
Published Online: 16 April 2015
Open Access
Summary
Background
Early
mobilisation after stroke is thought to contribute to the effects of
stroke-unit care; however, the intervention is poorly defined and not
underpinned by strong evidence. We aimed to compare the effectiveness of
frequent, higher dose, very early mobilisation with usual care after
stroke.
Methods
We did this
parallel-group, single-blind, randomised controlled trial at 56 acute
stroke units in five countries. Patients (aged ≥18 years) with ischaemic
or haemorrhagic stroke, first or recurrent, who met physiological
criteria were randomly assigned (1:1), via a web-based computer
generated block randomisation procedure (block size of six), to receive
usual stroke-unit care alone or very early mobilisation in addition to
usual care. Treatment with recombinant tissue plasminogen activator was
allowed. Randomisation was stratified by study site and stroke severity.
Patients, outcome assessors, and investigators involved in trial and
data management were masked to treatment allocation. The primary outcome
was a favourable outcome 3 months after stroke, defined as a modified
Rankin Scale score of 0–2. We did analysis on an intention-to-treat
basis. The trial is registered with the Australian New Zealand Clinical
Trials Registry, number ACTRN12606000185561.
Findings
Between
July 18, 2006, and Oct 16, 2014, we randomly assigned 2104 patients to
receive either very early mobilisation (n=1054) or usual care (n=1050);
2083 (99%) patients were included in the 3 month follow-up assessment.
965 (92%) patients were mobilised within 24 h in the very early
mobilisation group compared with 623 (59%) patients in the usual care
group. Fewer patients in the very early mobilisation group had a
favourable outcome than those in the usual care group (n=480 [46%] vs
n=525 [50%]; adjusted odds ratio [OR] 0·73, 95% CI 0·59–0·90; p=0·004).
88 (8%) patients died in the very early mobilisation group compared
with 72 (7%) patients in the usual care group (OR 1·34, 95% CI
0·93–1·93, p=0·113). 201 (19%) patients in the very early mobilisation
group and 208 (20%) of those in the usual care group had a non-fatal
serious adverse event, with no reduction in immobility-related
complications with very early mobilisation.
Interpretation
First
mobilisation took place within 24 h for most patients in this trial.
The higher dose, very early mobilisation protocol was associated with a
reduction in the odds of a favourable outcome at 3 months. Early
mobilisation after stroke is recommended in many clinical practice
guidelines worldwide, and our findings should affect clinical practice
by refining present guidelines; however, clinical recommendations should
be informed by future analyses of dose–response associations.
Funding
National
Health and Medical Research Council, Singapore Health, Chest Heart and
Stroke Scotland, Northern Ireland Chest Heart and Stroke, UK Stroke
Association, National Institute of Health Research.
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