From the Foundation for Health Services Research, Central Hospital of
Akershus, Nordbyhagen, Norway.
Correspondence to Ole Morten Rønning, Foundation for Health Services Research, Central Hospital of Akershus, 1474 Nordbyhagen, Norway. E-mail bguldvog{at}sia.pilot.akershus-f.kommune.no
MethodsA quasi-randomized, controlled study was undertaken
among 802 patients
ResultsCase fatality within the first 10 days was 8.2%
among patients in the stroke unit and 15.1% among patients in the
general medical ward (P=.0019). One-year survival among
patients treated in the stroke unit was 70.6% and in the general
medical wards 64.6% (P=.026); 18-month survival rates were
65.1% and 58.0%, respectively (P=.021). Among patients
with cerebral hemorrhage, 10-day case fatality was 24.5% and
51.6% (P=.004) in favor of the stroke unit.
ConclusionsStroke units increase survival rates among
stroke patients compared with general medical wards. The effect on
survival occurs early after the stroke and sustains during at least 18
months of observation.
This study was performed to test the hypothesis that stroke units with
a short hospitalization time would be effective for increased survival
among unselected stroke patients at least 1 year after the stroke. We
also wanted to analyze whether the possible differences in
survival were caused by events during hospitalization or whether
treatment in SU influenced survival even in the follow-up period after
discharge from hospital.
From January 1, 1993, patients older than 60 years were to be treated
in either the general medical ward or in the neurological department.
The selection of patients to either department was based on the first
two digits in the birth number. In the period January 1 to December 31,
1993, stroke patients born between the 1st and the 10th of each month
were treated in the SU, and patients born between the 11th and 31st
were treated in the general medical ward. From 1994, the SU expanded
and patients born between the 1st and 15th were treated in the SU.
Stroke Unit
A standard examination was performed including neurological assessment,
blood tests, electrocardiography, and a
computed tomography (CT) of the brain within 2 hours after admittance.
If an ischemic stroke was suspected after clinical and CT
evaluation, acetylic acid 160 mg was immediately administered per os.
As early as possible, the patient was mobilized, often within the first
hours after admittance to the hospital. The routine of mobilization of
patients with hemorrhages was the same as for those with
ischemic strokes. Patients with paralysis and patients who were
impossible to mobilize because of inability to cooperate were given
subcutaneous low-molecular-weight heparin. Parenteral isoosmolar fluid
was administered routinely the first 24 hours. Hyperglycemia was
treated with insulin when serum glucose was
General Medical Ward
Both Departments
Patients were followed up from entry to the study until August 1, 1996.
Details of age, gender, stroke type (hemorrhage or infarct),
and duration of hospitalization were recorded. The outcome measure
in this study was death. Information on death was collected through the
National Register, an official register containing name, date of birth,
address, and date of death. This register is continually updated. The
observation period for patients who had a stroke between January 1,
1993, and February 1, 1995, ranged from 547 to 1310 days for those who
were not dead by the end of the observation.
Twelve patients were excluded. They had either passed through the
county or visited family in the county when admitted to this hospital
with acute stroke and they were later transferred to their home in
another part of the country, or they had moved out of the district
during follow-up. Some of the patients in this study were involved in a
study evaluating the effect of supplemental oxygen (24.2% from SU and
19.2% from GMW, NS) and a study evaluating the effect of late
rehabilitation (18.4% from SU and 15.1% from GMW, NS).
Statistical Analysis
In our study, the difference in long-term survival could be explained
mostly by a lower case fatality among the patients treated in the SU
during the first 10 days, indicating the importance of the treatment
offered during this period. Analyzing the subgroup with
hemorrhage showed even more pronounced contrasts. From our
study, we may hypothesize that a considerable proportion of the effect
of stroke units on mortality is due to the treatment of patients with
hemorrhage. A noticeable feature in treatment that differed
between the SU and GMW was onset of mobilization of patients with
intracerebral bleeding. Patients treated in the SU were
mobilized early, independent of type of stroke, whereas in the GMW,
stroke patients with an intracerebral
hemorrhage were mobilized later and with more caution. Other
investigators have suggested that early mobilization of stroke patients
is important for a good result.14 15 27 Previous studies
have reported significantly longer length of stay than this
trial.21 23 27 The mean length of stay in our study was
just above 1 week in both treatment groups. The relatively short length
of stay suggests that early and acute treatment and intensive
mobilization is adequate to reduce mortality, but we do not consider a
length of stay of 1 week to be sufficient to achieve a good functional
recovery.
Randomization and Ethics
This is the first study of an SU with a short length of stay that has
shown a reduction of mortality. One-year survival in our treatment
groups is lower than in the groups reported in the
meta-analysis by Langhorne and collaborators (Stroke Unit
Trialists).15 The most probable explanation is that our
study included all patients with acute stroke, even those with the
worst prognosis and who were suspected to die within the first few
days. We did not include patients under the age of 60 years because
they were all treated in the SU. Because of that, we had a higher age
distribution in our selection of stroke patients and of course a
population with an overall higher risk of death. One strength of our
study is the higher number of patients included compared with previous
SU trials, thereby increasing the power of the study. We did not show
an absolute difference in survival rates that was much higher than in
many SU trials. We believe the reason for some studies failing to
document significant differences in long-term survival has been due to
lack of power of the study.
Which are the possible sources of bias of this study? The
information about the patients and the type of stroke in the
records should hold high standards. One of the researchers examined
every record carefully before coding. To test accuracy of coding,
several sets of records were assessed twice, revealing identical
results. The validity of the hospital records describing the
neurological conditions is assumed to be high because most patients
were observed for several days and examined by different doctors,
ensuring an accurate diagnosis. A study of this kind cannot be blinded,
and therefore there is a risk of exchange of information between the
departments regarding treatment. During the last decade an increasing
interest in stroke by the public and the professionals has taken place.
This interest in stroke may have increased the effort in the GMW and
could have reduced the benefit of the SU. The hospital, which is among
the five largest in Norway, should be of a high standard. It has
participated in international multicenter stroke trials (ECASS
I)28 and now takes part in ECASS II.29 The
number of patients included in these trials from this hospital as other
hospitals is relatively small and should not affect the results of this
study. The external validity of our trial should be high for the group
of patients with acute stroke who are 60 years and older, because all
patients with this diagnosis in the catchment area were offered
treatment in the hospital. General practitioners in the
area were reminded several times to refer all persons with acute stroke
to the hospital without delay.
Which are the possible explanations of the increased survival among
patients treated in the SU? Because we did not isolate specific parts
of the treatment package, we are still uncertain about which components
are most important. We believe, as other investigators do, that the
effects are probably caused by many components but mainly the
combination of early acute treatment and rehabilitation, the
multidisciplinary approach, and early detection and aggressive
treatment of complications.14 15 30 In contrast to other
stroke unit or rehabilitation studies,14 21 22 23 31 32
patients in this study were admitted exclusively very early after
onset. As a consequence, the early acute treatment may have contributed
more than in other trials. SU patients were examined with a CT within 2
hours after admission and given an acetylic acid tablet (enterocoated
acetylic acid 160 mg) immediately after CT examination when infarction
was suspected. Early administration of acetylic acid could have
prevented some early secondary strokes, reduced worsening of the
initial stroke, or prevented thromboembolic
complications.33 34 The most common diagnosis of those who
die immediately after stroke is primary intracerebral
hemorrhage.35 When patients with cerebral
infarctions die within the first days after stroke, it is often due to
complications of immobilization such as pneumonia, new strokes, or
pulmonary embolism.14 36 Patients in the SU were
brought out of bed soon after admittance, and some events of
aspirations may have been prevented because of this. Early mobilization
may have reduced the occurrence of both deep-vein thrombosis and
pulmonary embolism. The SU proved especially successful for
patients with hemorrhages. These patients are easier to
diagnose correctly because hemorrhages show up on CT scans
within the first hours after onset. The diagnosis was confirmed by
autopsy for patients who died in the hospital.
In conclusion, we found that treatment in the SU increased survival at
12 and 18 months after stroke onset. Patients with hemorrhages
benefited the most.
We expect our study to provide further information about whether an SU
with short length of stay has effect on morbidity, impairment,
depression, patient satisfaction, and quality of life.
Received June 23, 1997;
revision received September 18, 1997;
accepted October 23, 1997.
© 1998 American Heart Association, Inc.
Original Contributions
Stroke Units Versus General Medical Wards, I: Twelve- and Eighteen-Month Survival
A Randomized, Controlled Trial
![]()
Abstract
Top
Abstract
Introduction
Subjects and Methods
Results
Discussion
References
Background and PurposeThe long-term effect on survival
of treatment in stroke units is still under debate. The hypothesis that
a stroke unit with short length of stay increases 1-year and 18-month
survival rates was tested in this study.
60 years old admitted to the Central Hospital of
Akershus in Norway with a diagnosis of stroke between January 1, 1993,
and February 1, 1995. All patients with onset of symptoms <24 hours
before admittance were included and enrolled and were followed until
death or to the end of the observation 18 months after stroke. Patients
were allocated to a stroke unit (n=364) or a general medical ward
(n=438).
Key Words: emergency medical services outcome stroke units survival
![]()
Introduction
Top
Abstract
Introduction
Subjects and Methods
Results
Discussion
References
In the industrialized world, stroke is still
the third most common cause of death, although stroke mortality has
decreased during the last decades.1 2 3 4 5 6 More than 30% of
stroke patients die within 1 year after onset of
stroke.7 8 After a decline in stroke incidence during the
1960s and 1970s, some reports now show a stable or increasing
incidence.4 8 9 10 The incidence increases with age, and the
consequence of demographic changes could result in stroke becoming an
increasing cause of mortality and morbidity.11
Thrombolytic therapy is not recommended at the present
time except for a selective group of patients. No routine treatment is
effective and available for most acute stroke
victims.12 13 A randomized, controlled trial showed that
organized management reduced long-term institutional care, long-term
dependence, use of hospital resources, and short-term
mortality.14 A meta-analysis of randomized,
controlled trials reported between 1962 and 1996 by Langhorne and
collaborators (Stroke Unit Trialists)15 showed that
management of stroke patients in stroke units was associated with a
reduction in mortality 1 year after stroke. Some patients with the most
severe strokes in several of these studies were likely to have died
before they had a chance of entry to the stroke unit (SU) because of
late entry. A question still unanswered is whether the effectiveness of
SU is a result of early treatment or later rehabilitation efforts. SU
are known to be effective for increased survival for selected patients;
however, when the length of stay is relatively long, it has not been
shown that SU are effective for increased survival for unselected
stroke patients with a short length of stay.
![]()
Subjects and Methods
Top
Abstract
Introduction
Subjects and Methods
Results
Discussion
References
The Central Hospital of Akershus county serves a population of
291 905, of whom 49 303 are 60 years or older.16 Since
1992, guidelines were developed that recommended all patients with
acute stroke to be admitted as early as possible to the hospital.
Between January 1, 1993, and February 1, 1995, 1120 patients were
admitted to the hospital with a diagnosis of stroke and 802 were
included in the study. The trial involved all identified patients 60
years or older assessed in the hospital within 24 hours after having a
stroke. All strokes were included, both first strokes and recurrent
strokes. None of the patients were included more than once. Data were
collected prospectively (1994 to 1995) or retrospectively (1993) by
controlling patient medical records. If the patient arrived >24
hours after the stroke occurred, they were not assessed for this study.
Hence, among the 318 patients not included in this study, there are
patients who arrived >24 hours after stroke and patients who after a
closer examination did not have stroke or had a diagnosis mimicking
stroke. Stroke was defined according to WHO criteria as a vascular
lesion of the brain resulting in a neurological deficit persisting for
24 hours or resulting in death of the individual.17
Patients with primary subarachnoid hemorrhage or
subdural hematomas or with focal neurological deficits with duration
<24 hours were excluded from the study. None of the patients were
excluded because of severity, additional diseases, cognitive deficits,
prior strokes, or because they were living in nursing homes. The number
of patients with coma or patients from nursing homes did not differ
between the treatment groups (Table 1
).
View this table:
[in a new window]
Table 1. Characteristics of Eligible Stroke Patients
Allocated to Receive Care in General Medical Wards or the Stroke
Unit
The 10-bed acute SU could expand or contract with demand. The
medical treatment in the SU followed current practice guidelines for
the management of patients with acute stroke.12 18
12 mmol/L. Fever was
treated with antipyretics (paracetamol, 500 mg tablet) when temperature
was
38°C. Antihypertensive treatment was not initiated the first
week except for markedly elevated blood pressure. If cardioembolic
stroke was suspected, a cardiologist was consulted and eventually
anticoagualation was initiated. The staff was multidisiplinary with
neurologists, trained nurses, physiotherapists, occupational
therapists, and speech-therapists. A stroke team met weekly for
evaluation of the progress and to plan further treatment for each
patient. The nurses were specially trained to detect and avoid
complications. Special forms were constructed to discover changes
early. The physiotherapists followed the Bobath
technique19 and instructed the staff to follow this
approach during 24 hours. A multidisiplinary team met with the
relatives weekly to plan treatment and support after discharge.
The hospital has one department of medicine with five
wards. Stroke patients were admitted to all these wards, dependent on
capacity. Patients treated within the general medical wards (GMW) were
given traditional, good medical treatment without special efforts or
standardized effort toward this patient group. As in the SU, a CT scan
was requested but not routinely as an emergency examination. Patients
were immobilized until hemorrhage was excluded by
CT scan. Patients with ischemic strokes were then mobilized,
whereas patients with hemorrhages were often
immobilized for 1 week. Aspirin was given if the CT scan
did not reveal a bleeding. Prophylactic administration of
low-molecular-weight heparin was given to prevent venous thrombosis for
immobilized patients. There was no routine of giving
antipyretics or parenteral isoosmolar fluids, as in the SU.
Anticoagulation was started when a possible cardiogenic embolic source
was detected. Patients were offered physiotherapy, occupational
therapy, and evaluation of a neurologist when it was requested by the
staff.
After acute medical treatment, stabilization and early
rehabilitation patients were discharged either home, to nursing homes,
to community-based long-term rehabilitation, or to hospital-based
long-term rehabilitation. This treatment was given independent of their
early treatment. Among the patients in this study, 67 from the SU and
66 from the GMW were transferred to the hospital rehabilitation unit
(SU, 18.4%, and GMW, 15.1%). The difference was 3.3% (95%
confidence interval, 1.9% to 8.5%). The diagnosis was confirmed by
autopsy for patients who died in the hospital. CT scan of the brain was
performed on 793 patients (98.9%) and were interpreted by the same
radiologists.
We used a Cox regression model to calculate risk ratios (95%
confidence intervals) and cumulative survival in both groups. The risk
ratio of patients treated in the SU versus patients treated in the GMW
is the ratio of the estimated risk for a case treated in the SU to that
for a case treated in the GMW.
2 statistics and
two-sample t test were used when appropriate to determine
significance of differences among background variables compared.
Patients are studied on intention-to-treat basis. Even though data were
collected retrospectively, the sampling was on the basis of an input
variable (treatment) and hence produces a cohort (prospective)
study.20
![]()
Results
Top
Abstract
Introduction
Subjects and Methods
Results
Discussion
References
Demographic characteristics and prior medical history did not
differ between 364 patients randomized to the stroke unit and 438
patients to the medical wards (Table 1
). The distributions of the type
of stroke were similar in the groups: 14.6% in the SU and 14.4% in
the GMW had intracerebral bleeding confirmed by CT
scan. Characteristics and medical history of the patients with
intracerebral bleeding are shown in Table 2
. Survival plots of the two groups are
shown in Fig 1
. After an initially higher
case-fatality rate among patients in the GMW during the first weeks,
the slope of the two curves is marginally different. A difference in
case fatality of about 5% to 6% occurred during the initial period
and was sustained until the end of the observation. Table 3
shows the percent mortality and the
risk ratios between treatment at different follow-up intervals.
Survival rates were significantly higher among patients treated in the
stroke unit at all time intervals. Tables 4
and 5
show mortality and risk ratios for patients with cerebral infarction
and intracerebral hemorrhage, separately. The
initial mortality was especially high among the 115 patients who had an
intracerebral hemorrhage. Figs 2
and 3
show cumulative survival plots among patients with cerebral infarction
and intracerebral hemorrhages for the two
treatment groups. During the first weeks the case fatality is
significantly higher among patients with intracerebral
hemorrhage treated in the GMW, but the slope of the two curves
seems similar after the initial period. The
20% to 25% absolute
difference in the proportion of patients who died in the two groups
appeared during the first 50 days and then stabilized.
View this table:
[in a new window]
Table 2. Characteristics of Stroke Patients With
Intracerebral Bleeding

View larger version (11K):
[in a new window]
Figure 1. Cumulative survival rates by treatment group
(n=802).
indicates stroke unit; - - - - , medical wards.
View this table:
[in a new window]
Table 3. Percent Mortality by Treatment Groups at Different
Times After Initial Stroke
View this table:
[in a new window]
Table 4. Percent Mortality After Cerebral Infarction by
Treatment Groups at Different Times
View this table:
[in a new window]
Table 5. Percent Mortality After
Intracerebral Hemorrhage by Treatment Groups at
Different Times

View larger version (13K):
[in a new window]
Figure 2. Cumulative survival rates by treatment group
for patients with cerebral infarction (n=693).
indicates stroke
unit; - - - - , medical wards.

View larger version (12K):
[in a new window]
Figure 3. Cumulative survival rates by treatment group
for patients with intracerebral hemorrhage
(n=115).
indicates stroke unit; - - - - , medical wards.
![]()
Discussion
Top
Abstract
Introduction
Subjects and Methods
Results
Discussion
References
This study confirmed the effectiveness of SU to enhance survival
among stroke patients even among unselected stroke patients with a
short length of stay. It is the first randomized, controlled trial
focusing on survival showing significant differences in survival as
long as 18 months after the stroke, and it is the largest randomized
study of its kind. In this particular study, patients with
hemorrhages benefited the most. Patients entering this study
presented with an acute stroke, and the diagnosis was confirmed
during the hospitalization. Some previous controlled trials found SU
beneficial in reducing short-term case fatality.21 22 One
study showed increased survival among patients treated in SU, but the
difference had disappeared at follow-up 12 months after the
stroke.14 In other randomized stroke trials, survival was
not affected by treatment in GMW or SU.23 24 A
meta-analysis of SU trials reported a significant improvement
in survival after 1 year.15 However, this analysis
was as the authors described, based on a heterogeneous
group of trials. Because of reports of discrepancies between the
results of meta-analysis and findings of large randomized
trials, some researchers have focused on the limitations of such
analyses.25 26
The formal randomization procedure should ensure that groups be
comparable. The age and sex distribution and the proportion of stroke
subgroups indicate that the randomization was effective. In this
particular study the intention-to-treat and on-treatment groups were
practically identical.
![]()
References
Top
Abstract
Introduction
Subjects and Methods
Results
Discussion
References
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