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Articles
How Do Stroke Units Improve Patient Outcomes?
A Collaborative Systematic Review of the Randomized Trials

This Article
Stroke.
1997;28:2139-2144
doi: 10.1161/​01.STR.28.11.2139

Background and Purpose We sought to clarify the way in which organized
inpatient (stroke unit) care can produce reductions in case fatality and in the
need for institutional care after stroke.
Methods We performed a secondary analysis of a collaborative systematic
review of all randomized trials that compared organized inpatient (stroke unit)
care with contemporary conventional care. Nineteen trials were included, of
which 18 (3246 patients) could provide outcome data on death, place of
residence, and final functional outcome. Data were less complete (but always
available for at least 12 trials; 1611 patients) for subgroup analyses examining
timing and cause of death and outcomes in patients with different levels of
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Stroke Unit Trialists’ Collaboration
Correspondence to P. Langhorne, PhD, MRCP, Academic Section of Geriatric
Medicine, 3rd Floor, Center Block, Royal Infirmary, Glasgow G4 0SF, Scotland. Email [email protected]

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severity of initial stroke.
Results The reduction in case fatality of patients managed in a stroke unit
setting developed between 1 and 4 weeks after the index stroke. The reduction
in the odds of death was evident across all causes of death and most marked
for those deaths considered to be secondary to immobility. However, data were
insufficient to permit a firm conclusion. The relative increase in the number of
patients discharged home from stroke units as opposed to conventional care
was largely attributable to an increase in the number of patients returning
home physically independent. Across the range of stroke severity, stroke unit
care was associated with nonsignificant increases in the number of patients
regaining independence.
Conclusions Within the limitations of the available data, we conclude that
organized inpatient stroke unit care probably benefits a wide range of stroke
patients in a variety of different ways, ie, reducing death from secondary
complications of stroke and reducing the need for institutional care through a
reduction in disability.
Key Words:

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2.

Abstract
Methods
Results
Discussion

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Acknowledgments
Footnotes
References

meta-analysis
outcome
rehabilitation
stroke management
stroke units

A recent systematic review of the randomized trials that have compared
organized inpatient (stroke unit) care with contemporary conventional care has
indicated that stroke patients who are managed in an organized (stroke unit)
setting are less likely to die, remain physically dependent, or require long-term
1
institutional care. These observations were surprising because the stroke units
studied did not routinely employ any medical or surgical interventions that
might be expected to influence the pathological process or immediate
1
neurological complications of stroke disease. Furthermore, no routine medical
23
or surgical therapies have yet been shown to be effective in acute stroke.
It has previously been suggested that stroke unit care could be effective
4 5 6
through a number of mechanisms.
The provision of standardized
assessment and early management protocols may allow a more accurate
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diagnosis to be reached, more appropriate investigations, and more appropriate
individualized patient care. Secondary complications of stroke (eg, chest
infection, venous thromboembolism) could possibly be prevented through
improved assessment procedures and early active rehabilitation. Earlier, more
intense, and better coordinated rehabilitation procedures may assist patients in
achieving their maximal functional outcome. However, to date there has been a
lack of direct evidence to support any of these proposals.
An improved understanding of the way in which stroke units exert their
beneficial effect on stroke outcomes is of considerable clinical importance
because it could help to elucidate the mechanisms of improved recovery and
hence important practical aspects of stroke care.
In this report we use data available from a collaborative systematic review of
1
the available randomized trials of stroke unit care to identify the aspects of
recovery for which stroke unit care appeared to make the greatest impact. In
particular, we wished to identify the following: (1) What causes of death were
most likely to be prevented? (2) Did stroke unit care result in more patients
surviving in a physically dependent state? (3) Did all groups of patients obtain
similar benefit from stroke unit care?

Methods
Systematic Review
The methods used for the collaborative systematic review of the randomized
1
trials of stroke unit care have been described previously. In summary, we
identified randomized trials of organized inpatient (stroke unit) care for the
1
period up to December 1995 using a variety of search strategies. We aimed to
include all trials that compared management in an organized (stroke unit)
setting with that of contemporary conventional care (usually provided within
general medical wards). The coordinators of all relevant randomized trials were
then contacted and invited to join a collaborative review group (Stroke Unit
Trialists’ Collaboration). The trial coordinators provided data in a standardized
format concerning the trial characteristics, patient selection criteria and
1
characteristics, and the numbers of patients in each outcome group.
Subgroup data (either in the form of tabular or individual patient data) were
also sought, in particular the initial stroke severity, which was defined in terms
1
of the functional status of the patient at the time of randomization. In this
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categorization, a patient with a mild stroke had a functional status
approximately equivalent to a Barthel Index score of greater than 50/100 within
the first week after the stroke and greater than 65/100 within 2 weeks.
Moderate strokes were characterized by a score intermediate between the mild
and severe subgroups. A severe stroke was equivalent to a Barthel Index score
of less than 15/100 within the first week and less than 20/100 within 2 weeks
after stroke.
Outcomes
The main outcomes of interest in this analysis were (1) death, (2) the duration
elapsed between the index stroke and death, (3) the certified cause of death
(ie, clinician’s diagnosis), (4) the final functional status (Rankin score or
equivalent measure of dependency, and (5) the requirement for long-term
institutional care (ie, within a residential home, nursing home, or hospital
setting).
The certified primary cause of death reported was allocated into the following
7
categories : (1) neurological: death attributable to the index stroke or recurrent
stroke, ie, stroke, cerebral infarction, brain herniation, cerebral edema,
recurrent stroke; (2) cardiovascular: myocardial infarction, congestive cardiac
failure, cardiac arrhythmia, cardiac arrest; (3) complications of immobility: any
death that might reasonably be considered a complication of immobility, ie,
sepsis (particularly chest or urinary tract), venous thromboembolism, decubitus
ulceration; and (4) other causes: other illnesses (eg, malignancy).
Statistical Methods
Patterns of case fatality over time were analyzed as the proportion of patients,
for whom information was available, who were known to be dead at specific
census times after the index stroke. This simple approach, which provides a
series of “snapshots” of outcomes at various census times, was used because
insufficient individual patient data were available for more sophisticated
survival curve analysis.
Relative differences in dichotomous outcomes were analyzed by calculating the
odds ratio (OR) (plus the 95% confidence interval [CI]) of an adverse outcome
occurring in the stroke unit group relative to the control (conventional care)
8 9
group.
We used the risk difference to calculate the absolute outcome rates
(ie, the proportion of patients with a particular outcome) because this can
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provide additional clinical information to relative outcomes. However, when the
results of the stroke unit and control groups were compared, all calculations of
statistical significance were based on the z statistic of the OR of that
89
comparison.
When data from several trials were used to calculate a summary result, we
calculated the heterogeneity between the individual trial data contributing to
89
that summary result using standard techniques.
Nonsignificant heterogeneity
tests (P>.05) indicate that the results from the individual trials were all
compatible with the summary result. Fixed effects statistical models were
8
used unless heterogeneity tests were significant when a “random effects”
9
model was used.

Results
Description of Trials
A total of 19 trials were identified up to December 1995; 17 were formally
randomized with the use of random numbers or sealed envelopes (References
10
10 -25 and A. Svensson, P. Harmsen, L. Wilhelmsen, unpublished data, 1988),
and an additional 2 trials (containing a total of 405 patients) used informal
26
27
procedures based on bed availability or a strict admission rota. Exclusion of
the 2 quasi-randomized trials would have no substantial effect on any of the
13
subsequent conclusions. One of the trials
has not yet been completed; the
remaining 18 trials have randomized a total of 3249 patients.
Ten of the 18 trials (which randomized 2063 patients) evaluated units with an
immediate admission policy; the remaining 8 trials (1186 patients) were of
2
units in which admission was usually delayed 1 to 2 weeks after stroke.
Typically all patients allocated to organized inpatient (stroke unit) care received
inpatient rehabilitation characterized by a period (of up to several weeks) of
coordinated multidisciplinary rehabilitation by a team with a specialist interest
in stroke disease and/or rehabilitation that had programs of education and
1
training in stroke. Most of the control patients (1346 patients) received
conventional care in a general medical ward that did not incorporate the above
characteristics. A small number (277) of control patients were exposed to some
11 20 21 24
multidisciplinary rehabilitation in a mixed rehabilitation setting.
For
the purposes of this analysis, they were analyzed with the rest of the control
group who were managed in general medical wards.
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Case Fatality
Data were available on the time of death for 14 trials (2463 patients
randomized), of which 10 trials could provide information on exact date of
death and 4 gave information at census times. Fig 1⇓ illustrates the proportion
of patients who were known to be dead at intervals after the index stroke. In 13
of the 14 trials the rise in case fatality among patients exposed to organized
(stroke unit) care was less marked than (or the same as) those exposed to
conventional care. The apparent number of lives saved (ie, the proportion dead
in the conventional care setting minus the proportion dead in the stroke unit
setting) is also shown. This indicates that the observed differences largely
developed during the period of 1 to 4 weeks after the index stroke. These
results do not differ substantially if we analyze separately data from stroke
units that had an acute admission policy and those that routinely employed a
delayed admission policy because the majority of death events (507 [76%] of
all recorded deaths) occurred in trials in which an acute admission policy was
examined.
Figure 1.
Proportion of patients known to
be dead after the index stroke
and cumulative difference
between stroke unit and control
subjects.

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Cause of Death
Information on cause of death was available for 12 trials (1611 patients
randomized). The proportions of stroke unit and control group patients dying
within particular categories of certified cause of death were as follows: (1)
neurological: 9.2% stroke unit patients, 10.3% control subjects (OR, 0.92; 95%
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CI, 0.66 to 1.28); (2) cardiovascular: 5.2% stroke unit patients, 7.0% control
subjects (OR, 0.72; 95% CI, 0.47 to 1.09); (3) complications of immobility: 3.8%
stroke unit patients, 6.3% control subjects (OR, 0.62; 95% CI, 0.39 to 0.97); and
(4) other causes: 3.6% stroke unit patients, 4.2% control subjects (OR, 0.90; 95%
CI, 0.53 to 1.51). There was no significant heterogeneity between trials within
each of the outcome groups examined (P>.2 in each case).
It is clear that the analysis lacks sufficient statistical power to draw
unequivocal conclusions. We were also limited to using the certified cause of
death because insufficient numbers of autopsies were performed to allow a
meaningful sensitivity analysis based on the autopsy-proven cause of death.
Other Patient Outcomes
To estimate the impact of stroke unit care on a variety of patient outcomes, we
calculated the proportion of patients in four outcome categories at the end of
scheduled follow-up (median, 1 year after stroke). Table 1 ⇓ contains these
data, which were available for 14 trials (2770 patients randomized). Stroke unit
care was associated with an increase in the number of patients residing at
home in an “independent” state (Rankin score 0 to 2). There was only a
marginal increase in the odds of a patient being at home in a “dependent” state
(Rankin score 3 to 5), and there were reductions in the odds of death or
requiring institutional care.
Table 1.
Outcomes in Stroke Unit Trials

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There was no significant heterogeneity (P>.2) between the individual trials
contributing to the analyses with the exception of the home (dependent)
2
subgroup, which showed a χ of 27.1 (13 df; P<.05). In absolute terms the
increase in independent survival appears to be the most striking consequence
of organized inpatient (stroke unit) care.
The main limitation in this analysis is the lack of “blinding” of functional
assessments in some trials. However, results were similar if restricted to those
14 16 17 20 26
trials
that employed an unequivocally blinded outcome
assessment.
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Fig 2⇓ shows the proportion of subjects living at home and the cumulative
difference between stroke unit patients and the control group.
Figure 2.
Proportion of patients living at
home after the index stroke
and cumulative difference
between stroke unit and control
subjects.

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The apparent impact of stroke unit care on patients with different degrees of
initial stroke severity is shown in Table 2 ⇓, which presents the numbers of
patients surviving in either a physically dependent (Rankin score 3 to 5) or
independent (Rankin score 0 to 2) state. Data were available for 13 trials (2091
patients) at the end of scheduled follow-up (median, 1 year).
Table 2.
Outcomes Within Stroke
Severity Subgroups

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Patients with mild stroke managed in a stroke unit showed no net increase in
survival but tended to be more likely to regain independence. Patients suffering
a stroke of moderate severity showed a trend toward both increased survival
and increased independent survival. Stroke unit care resulted in an apparent
increase in both independent and dependent survival of severe stroke patients.
The severe stroke patient group was the only one in which stroke unit care also
resulted in an increase in physically “dependent” survivors. Overall, the trend is
toward improvement in all outcome groups, although conclusions are limited by
the relatively small patient numbers. There was no significant heterogeneity
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(P>.1) between trials contributing to the summary results. Restriction of the
14 16 17 20 26
analysis to those trials
that had used an unequivocally blinded
outcome assessment produced a similar pattern of results.

Discussion
This article presents one part of a larger analysis of the randomized stroke unit
1
trials. The first (hypothesis testing) component of this project used an a priori
hypothesis that organized inpatient (stroke unit) care is more effective than
conventional
care
and
obtained primary
outcome
data
(death,
institutionalization, dependency) from all relevant trials. All three primary
outcomes were significantly less frequent among patients managed in an
organized stroke unit setting compared with conventional care (usually in
1
general medical wards). The current (secondary) analysis attempted to
identify the way in which these apparent benefits were achieved. This analysis
is therefore more exploratory and is limited by two main problems. First, the
analyses are frequently not based on predefined a priori hypotheses and
therefore could be subject to bias. Second, the analyses were frequently
restricted to incomplete data sets (although data were always present for
randomly matched stroke unit and control groups and were available for more
than half the relevant trials). However, a knowledge of the methodological
limitations should serve to qualify the conclusions that can be drawn.
There have been many suggestions about how organized stroke unit care could
5 6 28
improve outcomes after a stroke (see
). It has been considered unlikely
that the initial stroke pathology and the immediate neurological consequences
of the stroke could be substantially influenced by a nonspecific intervention
29
6 29
such as stroke unit care. However, a number of authors
have suggested
that the frequency of several common complications after stroke (in particular,
cardiovascular complications, venous thromboembolism, and infections) may
be influenced. Although the current analysis appears to support this view, there
is insufficient statistical power to provide an unequivocal conclusion, even
within this pooled analysis. It is also important to recognize that we were
limited to using the certified cause of death, which is a potentially inaccurate
source of information (although in most circumstances it will represent the best
information available). Further circumstantial support for the view that stroke
unit care may reduce secondary complications of stroke is provided by the
observations on the timing of deaths within the stroke unit and control groups
(Fig 1⇑). Most of the deaths prevented were those occurring between 1 and 4
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weeks after the index stroke, which is the period of time in which many of the
7 29
complications of immobility are believed to occur.
It is possible to speculate on several possible mechanisms by which organized
stroke unit care could reduce deaths due to secondary complications after
stroke. A careful and systematic assessment of dysphagia may reduce the risk
of aspiration and subsequent chest infections. A reduction in the use of urinary
catheters could reduce the risk of urinary tract infection. It is also possible that
stroke unit staff offered more aggressive management of infections once these
complications had become established. Programs of early activation and
mobilization may reduce the risk of venous thromboembolism or cardiovascular
events. Unpublished data concerning the management strategies within the
stroke unit trials suggest that an insufficient number of patients were exposed
to specific drug or surgical therapies for these to have any significant impact on
the pooled results from the stroke unit trials.
We had previously observed that organized stroke unit care resulted in a
1
reduction in the need for long-term hospital or institutional care. This reduction
could in theory have resulted from either a more aggressive discharge policy or
from a reduction in the number of patients who remained disabled (and
therefore required institutional care). Clearly the former is of doubtful clinical
value, while the latter is of great therapeutic interest. The current analysis
(Table 1 ⇑) indicates that the reduction in the need for institutional care is
largely attributable to a reduction in patient dependency. Across the range of
levels of stroke severity observed, stroke unit care appeared to result in an
increase in the numbers of survivors who were judged to be physically
independent.
We can speculate on how stroke unit care could reduce disability (dependency)
after stroke. A more coordinated and focused program of rehabilitation
1
involving patients and caregivers may well allow caregivers to better assist
with the rehabilitation process to continue therapeutic strategies beyond formal
therapy sessions and thereby allow more patients to achieve independence.
Some but not all of the stroke units used a more intensive physiotherapy and
1
occupational therapy input than conventional care. In addition, less tangible
factors, such as the level of patient motivation and morale, may have been
30
improved in the stroke unit setting. Observational studies comparing patient
activity within stroke unit and the general ward settings have indicated that
stroke unit patients spend more of their time in more appropriate and
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purposeful activity.
The final question we wished to address was whether the benefits of organized
stroke unit care were equally apparent across a range of stroke levels of
severity. Our working hypothesis was that patients in the “middle band” of
4
stroke severity would gain most benefit. In fact, all groups appeared to
benefit, but in different ways (Table 2 ⇑). Patients with mild strokes, who are at
a relatively lower absolute risk of death, showed no net increase in survival, but
more survivors regained physical independence. More of the moderate severity
stroke patients survived and became independent. Those at highest risk of
death (severe stroke patients) showed the largest absolute increase in survival
with increases in the numbers of both dependent and independent survivors.
Overall, the increase in independent survivors is substantially greater than the
increase in dependent survivors, and the net effect of stroke unit care appears
to be to shift the distribution of all outcomes in a favorable direction.
In summary, this secondary analysis of a systematic review of the randomized
stroke unit trials has indicated that the observed benefits of stroke unit care
probably resulted from a reduction in deaths caused by secondary
complications of stroke (predominantly complications of immobility) and a
reduced requirement for institutional care through a reduction in patient
dependency. The net effect of stroke unit care appears to be to shift the
distribution of all observed outcomes in a favorable direction.

Acknowledgments
This study was supported by Chest, Heart, and Stroke, Scotland. Following is a
list of collaborators (in alphabetical order): K. Asplund (Professor, Umea
University Hospital, Umea, Sweden); P. Berman (Physician, City Hospital,
Nottingham, England); C. Blomstrand (Neurologist, Sahlgrenska University
Hospital, Goteborg, Sweden); M. Dennis (Secretariat; Senior Lecturer, Western
General Hospital, Edinburgh,UK); T. Erila (Neurologist, Tampere University
Hospital, Tampere, Finland); M. Garraway (Professor, Public Health Sciences,
University of Edinburgh, UK); E. Hamrin (Professor, Linkoping University,
Linkoping, Sweden); G. Hankey (Neurologist, Royal Perth Hospital, Perth,
Australia); M. Ilmavirta (Neurologist, Central Hospital, Jyvaskyla, Finland); B.
Indredavik (Physician, University Hospital, Trondheim, Norway); L. Kalra
(Professor, Orpington Hospital, Kent, England); M. Kaste (Professor, University
of Helsinki, Helsinki, Finland); P. Langhorne (Coordinator; Senior Lecturer, Royal
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Infirmary, Glasgow, UK); H. Rodgers (Physician, University of Newcastle,
England); J. Sivenius (Professor, University of Kuopio, Kuopio, Finland); J.
Slattery (Secretariat; Statistician, University of Edinburgh, UK); R. Stevens
(Retired Physician, formerly Dover, England); A. Svensson (Professor, Ostra
Hospital, Goteborg, Sweden); C. Warlow (Secretariat; Professor, Western
General Hospital, Edinburgh, UK) B. Williams (Secretariat; Physician, Gartnavel
General Hospital, Glasgow, UK); S. Wood-Dauphinee (Professor, McGill
University, Montreal, Canada). In addition to the listed collaborators, important
contributions were also made by D. Deleo (Perth), A. Drummond (Nottingham),
R. Fogelholm (Jyvaskyla), N. Lincoln (Nottingham), H. Palomaki (Helsinki), T.
Strand (Umea), and L. Wilhelmsen (Goteborg). Carl Counsell and Hazel Fraser
(Cochrane Collaboration Stroke Group) provided invaluable assistance with
literature searching.

Footnotes
A list of participants in this multicenter study appears at the end of the
article.
Received February 14, 1997.
Revision received May 6, 1997.
Accepted June 2, 1997.
Copyright © 1997 by American Heart Association

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rehabilitation practice on hospital wards for stroke patients. Stroke.
1996;27:18-33. Abstract/FREE Full Text



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