(Stroke. 1997;28:2139-2144.)
© 1997 American Heart Association, Inc.
Articles |
Correspondence to P. Langhorne, PhD, MRCP, Academic Section of Geriatric Medicine, 3rd Floor, Center Block, Royal Infirmary, Glasgow G4 0SF, Scotland. E-mail P.Langhorne{at}clinmed.gla.ac.uk
| Abstract |
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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 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: meta-analysis outcome rehabilitation stroke management stroke units
| Introduction |
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It has previously been suggested that stroke unit care could be effective through a number of mechanisms.4 5 6 The provision of standardized assessment and early management protocols may allow a more accurate 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 the available randomized trials of stroke unit care1 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 |
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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 of the functional status of the patient at the time of randomization.1 In this 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 categories7 : (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) group.8 9 We used the risk difference to calculate the absolute outcome rates (ie, the proportion of patients with a particular outcome) because this can 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 comparison.8 9
When data from several trials were used to calculate a summary result, we calculated the heterogeneity between the individual trial data contributing to that summary result using standard techniques.8 9 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 used8 unless heterogeneity tests were significant when a "random effects" model was used.9
| Results |
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Ten of the 18 trials (which randomized 2063 patients) evaluated units with an immediate admission policy; the remaining 8 trials (1186 patients) were of units in which admission was usually delayed 1 to 2 weeks after stroke.2
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 training in stroke.1 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 multidisciplinary rehabilitation in a mixed rehabilitation setting.11 20 21 24 For the purposes of this analysis, they were analyzed with the rest of the control group who were managed in general medical wards.
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.
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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% 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.
|
There was no significant heterogeneity
(P>.2) between the individual trials contributing to the
analyses with the exception of the home (dependent)
subgroup, which showed a
2 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 trials14 16 17 20 26 that employed an unequivocally blinded outcome assessment.
Fig 2
shows the proportion of subjects living
at home and the cumulative difference between stroke unit patients and
the control group.
|
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).
|
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 (P>.1) between trials contributing to the summary results. Restriction of the analysis to those trials14 16 17 20 26 that had used an unequivocally blinded outcome assessment produced a similar pattern of results.
| Discussion |
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There have been many suggestions about how organized stroke unit care
could improve outcomes after a stroke (see 5 6 28 ). 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 such as stroke
unit care.29 However, a number of authors6 29
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 weeks after the index stroke, which is the
period of time in which many of the complications of immobility are
believed to occur.7 29
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 reduction in the need for long-term hospital or institutional
care.1 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 involving patients and caregivers1 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 occupational therapy input1 than conventional care. In addition, less tangible factors, such as the level of patient motivation and morale, may have been improved in the stroke unit setting. Observational studies30 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 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 stroke severity would gain most
benefit.4 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 |
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| Footnotes |
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Received February 14, 1997; revision received May 6, 1997; accepted June 2, 1997.
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A. Evans, F. Harraf, N. Donaldson, and L. Kalra Randomized Controlled Study of Stroke Unit Care Versus Stroke Team Care in Different Stroke Subtypes Stroke, February 1, 2002; 33(2): 449 - 455. [Abstract] [Full Text] [PDF] |
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P. W. Duncan, R. D. Horner, D. M. Reker, G. P. Samsa, H. Hoenig, B. Hamilton, B. J. LaClair, T. K. Dudley, and M. Kelly-Hayes Adherence to Postacute Rehabilitation Guidelines Is Associated With Functional Recovery in Stroke * Editorial Comment Stroke, January 1, 2002; 33(1): 167 - 178. [Abstract] [Full Text] [PDF] |
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K McPherson, L Headrick, and F Moss Working and learning together: good quality care depends on it, but how can we achieve it? Qual. Saf. Health Care, December 1, 2001; 10(90002): ii46 - 53. [Abstract] [Full Text] [PDF] |
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E. Wilson, G. Taylor, S. Phillips, P. J. Stewart, G. Dickinson, V. R. Ramsden, R. W. Teasell, N. Mayo, J. Tu, S. Elson, et al. Creating a Canadian stroke system Can. Med. Assoc. J., June 1, 2001; 164(13): 1853 - 1855. [Full Text] [PDF] |
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D. E. Briggs, R. A. Felberg, M. D. Malkoff, P. Bratina, and J. C. Grotta Should Mild or Moderate Stroke Patients Be Admitted to an Intensive Care Unit? Stroke, April 1, 2001; 32(4): 871 - 876. [Abstract] [Full Text] [PDF] |
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L. Claesson, G. Gosman-Hedstrom, M. Johannesson, B. Fagerberg, and C. Blomstrand Resource Utilization and Costs of Stroke Unit Care Integrated in a Care Continuum: A 1-Year Controlled, Prospective, Randomized Study in Elderly Patients : The Goteborg 70+ Stroke Study Stroke, November 1, 2000; 31(11): 2569 - 2577. [Abstract] [Full Text] [PDF] |
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T. Brott and J. Bogousslavsky Treatment of Acute Ischemic Stroke N. Engl. J. Med., September 7, 2000; 343(10): 710 - 722. [Full Text] [PDF] |
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S. Sinha and E.A. Warburton The evolution of stroke units--towards a more intensive approach? QJM, September 1, 2000; 93(9): 633 - 638. [Full Text] [PDF] |
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J. Slany, H. S. Jorgensen, DMSci, L. P. Kammersgaard, J. Houth, H. Nakayama, K. Larsen, T. S. Olsen, H. O. Raaschou, and P. Hubbe Treatment in the Stroke Unit Response Stroke, September 1, 2000; 31 (9): 2266 - 2278. [Full Text] [PDF] |
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D. Sulch, I. Perez, A. Melbourn, and L. Kalra Randomized Controlled Trial of Integrated (Managed) Care Pathway for Stroke Rehabilitation Stroke, August 1, 2000; 31(8): 1929 - 1934. [Abstract] [Full Text] [PDF] |
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H. J. M. Barnett and A. M. Buchan The Imperative to Develop Dedicated Stroke Centers JAMA, June 21, 2000; 283(23): 3125 - 3126. [Full Text] [PDF] |
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B. B. Johansson Brain Plasticity and Stroke Rehabilitation : The Willis Lecture Stroke, January 1, 2000; 31(1): 223 - 230. [Abstract] [Full Text] [PDF] |
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B. Indredavik, F. Bakke, S. A. Slordahl, R. Rokseth, and L. L. Haheim Stroke Unit Treatment : 10-Year Follow-Up Stroke, August 1, 1999; 30(8): 1524 - 1527. [Abstract] [Full Text] [PDF] |
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B. Indredavik, F. Bakke, S. A. Slordahl, R. Rokseth, and L. L. Haheim Treatment in a Combined Acute and Rehabilitation Stroke Unit : Which Aspects Are Most Important? Stroke, May 1, 1999; 30(5): 917 - 923. [Abstract] [Full Text] [PDF] |
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B. Stegmayr, K. Asplund, K. Hulter-Asberg, B. Norrving, M. Peltonen, A. Terent, and P. O. Wester Stroke Units in Their Natural Habitat : Can Results of Randomized Trials Be Reproduced in Routine Clinical Practice? Stroke, April 1, 1999; 30(4): 709 - 714. [Abstract] [Full Text] [PDF] |
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L. N. Joseph, V. L. Babikian, N. C. Allen, and M. R. Winter Risk Factor Modification in Stroke Prevention : The Experience of a Stroke Clinic Stroke, January 1, 1999; 30(1): 16 - 20. [Abstract] [Full Text] [PDF] |
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Other Articles Noted Evid. Based Nurs., October 1, 1998; 1(4): 100 - 104. [Full Text] |
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L. B. Goldstein, L. A. Hey, and R. Laney North Carolina Stroke Prevention and Treatment Facilities Survey : rtPA Therapy for Acute Stroke Stroke, October 1, 1998; 29(10): 2069 - 2072. [Abstract] [Full Text] [PDF] |
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