10
Topical review Stroke units: many questions, some answers Blanca Fuentes and Exuperio Dı ´ez-Tejedor Background The development of specialized stroke units has been a landmark innovation in acute stroke care. However, the high scientific evidence level for the recommendation for stroke units to provide clinical attention for acute stroke patients does not correspond to the level of stroke unit implementation. A narrative, nonsystematic review on pub- lished studies on stroke units was conducted, with special emphasis on those demonstrating their efficacy and effec- tiveness. We also attempt to provide some answers to several open questions regarding practical issues of stroke units. Summary of review Stroke units represent the most effica- cious model for care provision compared with general ward care and stroke teams. Every stroke patient can benefit from stroke unit care. These units are efficient, cost-effective and their benefits are consistent over time. Compared with other specific stroke therapies such as aspirin or intravenous throm- bolytic agents, stroke units have a higher target population and higher benefit in terms of number of deaths and/or dependencies avoided. New approaches in stroke unit man- agement such as the implementation of noninvasive monitor- ing or alternative clinical pathways could improve their benefit even further. Conclusion Stroke units are cost-effective and need to be considered as a priority in health-care provision for stroke patients. Key words: effectiveness, efficacy, efficiency, stroke team, stroke unit, stroke The development of stroke units (SUs) has been a milestone in the care provision for patients who have suffered a stroke. From a nihilistic approach in which the clinical evolution of the patient was allowed to proceed uninterrupted, the care for these patients has progressed to being considered as a first-level neurological emergency. However, despite the high grade of scientific evidence on which the recommendations for SUs for care provision of the patients with acute stroke are based, there is no correspondence with the level of implementation of these SUs worldwide (1, 2). There are few studies and surveys analyzing the current population coverage from SU and the differences between countries are clear. In Scandinavian coun- tries, up to 60–70% of stroke patients are managed in SU while in other European countries like the United Kingdom or Germany it reaches only 30–36% and in France or Italy o 10% (3). In Australia, only 19% of 261 acute public hospitals participating in a cross-sectional survey claimed to have an SU, and they did not treat all the stroke patients presenting to their hospitals (4). In the United States, data from a survey conducted in North Carolina showed that 45% of acute stroke patients have access to SU care (5). Finally, in the Canadian Stroke Network report in 2004, only 18% of acute stroke patients were admitted to an SU (6). Probably, in no other therapy with level I evidence based on randomized studies and meta-analyses has there been such a clear need for implemen- tation of SUs. Our objective is to review the current issues associated with the provision of SU care from an international perspective. Concept and historical development SU is usually defined as ‘a geographic location within the hospital designated for stroke patients who are in need of rehabilitation services and skilled professional care that such a unit can provide’ (7). But several categories of SU have also been defined mainly based on admission policy (acute admis- sion units, which admitted patients at stroke onset (within 1 week); delayed admission units, which admitted patients after a delay of at least 1 week and that are mainly focused on rehabilitation). On the other hand, mixed or comprehensive units are characterized by a combination of acute admission with a period of rehabilitation (7). Acute SUs are defined as those areas dedicated to the care (non or semi-intensive) during the acute phase and, once stabilized, the patient is transferred to the general neurology ward, where the diagnos- tic–therapeutic process continues up until the discharge from hospital, or transfer to rehabilitation or to geriatric units (8, 9). Correspondence: Exuperio Dı ´ez-Tejedor , Department of Neurology, Hospital Universitario La Paz, Autonomous University of Madrid, Paseo de la Castellana, 261, 28046 Madrid, Spain. Tel: (134) 917 277 444; Fax: (134) 913 581 403; e-mail: [email protected] Stroke Unit, Department of Neurology, University Hospital La Paz, Autonomous University of Madrid, Madrid, Spain & 2009 The Authors. 28 Journal compilation & 2009 World Stroke Organization International Journal of Stroke Vol 4, February 2009, 28–37

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Page 1: Stroke units: many questions, some answers

Topical review

Stroke units: many questions, some answers

Blanca Fuentes and Exuperio Dıez-Tejedor�

Background The development of specialized stroke units has

been a landmark innovation in acute stroke care. However,

the high scientific evidence level for the recommendation for

stroke units to provide clinical attention for acute stroke

patients does not correspond to the level of stroke unit

implementation. A narrative, nonsystematic review on pub-

lished studies on stroke units was conducted, with special

emphasis on those demonstrating their efficacy and effec-

tiveness. We also attempt to provide some answers to several

open questions regarding practical issues of stroke units.

Summary of review Stroke units represent the most effica-

cious model for care provision compared with general ward

care and stroke teams. Every stroke patient can benefit from

stroke unit care. These units are efficient, cost-effective and

their benefits are consistent over time. Compared with other

specific stroke therapies such as aspirin or intravenous throm-

bolytic agents, stroke units have a higher target population

and higher benefit in terms of number of deaths and/or

dependencies avoided. New approaches in stroke unit man-

agement such as the implementation of noninvasive monitor-

ing or alternative clinical pathways could improve their

benefit even further.

Conclusion Stroke units are cost-effective and need to be

considered as a priority in health-care provision for stroke

patients.

Key words: effectiveness, efficacy, efficiency, stroke team,

stroke unit, stroke

The development of stroke units (SUs) has been a milestone in

the care provision for patients who have suffered a stroke.

From a nihilistic approach in which the clinical evolution of

the patient was allowed to proceed uninterrupted, the care for

these patients has progressed to being considered as a first-level

neurological emergency. However, despite the high grade of

scientific evidence on which the recommendations for SUs for

care provision of the patients with acute stroke are based, there

is no correspondence with the level of implementation of these

SUs worldwide (1, 2). There are few studies and surveys

analyzing the current population coverage from SU and the

differences between countries are clear. In Scandinavian coun-

tries, up to 60–70% of stroke patients are managed in SU while

in other European countries like the United Kingdom or

Germany it reaches only 30–36% and in France or Italy o10% (3). In Australia, only 19% of 261 acute public hospitals

participating in a cross-sectional survey claimed to have an SU,

and they did not treat all the stroke patients presenting to their

hospitals (4). In the United States, data from a survey

conducted in North Carolina showed that 45% of acute stroke

patients have access to SU care (5). Finally, in the Canadian

Stroke Network report in 2004, only 18% of acute stroke

patients were admitted to an SU (6). Probably, in no other

therapy with level I evidence based on randomized studies and

meta-analyses has there been such a clear need for implemen-

tation of SUs. Our objective is to review the current issues

associated with the provision of SU care from an international

perspective.

Concept and historical development

SU is usually defined as ‘a geographic location within the

hospital designated for stroke patients who are in need of

rehabilitation services and skilled professional care that such a

unit can provide’ (7). But several categories of SU have also

been defined mainly based on admission policy (acute admis-

sion units, which admitted patients at stroke onset (within

1 week); delayed admission units, which admitted patients

after a delay of at least 1 week and that are mainly focused on

rehabilitation). On the other hand, mixed or comprehensive

units are characterized by a combination of acute admission

with a period of rehabilitation (7). Acute SUs are defined as

those areas dedicated to the care (non or semi-intensive)

during the acute phase and, once stabilized, the patient is

transferred to the general neurology ward, where the diagnos-

tic–therapeutic process continues up until the discharge from

hospital, or transfer to rehabilitation or to geriatric units (8, 9).

Correspondence: Exuperio Dıez-Tejedor�, Department of Neurology,

Hospital Universitario La Paz, Autonomous University of Madrid, Paseo

de la Castellana, 261, 28046 Madrid, Spain. Tel: (134) 917 277 444; Fax:

(134) 913 581 403; e-mail: [email protected]

Stroke Unit, Department of Neurology, University Hospital La Paz,

Autonomous University of Madrid, Madrid, Spain

& 2009 The Authors.28 Journal compilation & 2009 World Stroke Organization International Journal of Stroke Vol 4, February 2009, 28–37

Page 2: Stroke units: many questions, some answers

To date, there exist some variabilities in the medical depart-

ments in which the SU are established: geriatric medicine,

general medicine, neurology and rehabilitation medicine.

Although all of these possibilities shared the multidisciplinary

team care approach, general medicine and neurology are more

focused on acute and more disease-specific approaches and

geriatric and rehabilitation medicine on a more generic

disability approach (7).

Although in several countries stroke expertise may reside

within other hospital departments (e.g. general medicine,

geriatric medicine), mainly depending on the Health Policy

and on the different medical specialization developing and

availability, acute SUs are recommended to be situated in a

specific area within the Neurology department of the hospital

and with dedicated beds. It should be of a multidisciplinary

structure coordinated by a neurologist specializing in cere-

brovascular disease, and with specially trained support per-

sonnel (9). There need to be predefine criteria of admission,

explicit diagnostic and treatment protocols and work pro-

grams coordinated with other specialties such as cardiology,

neuroradiology, neurosurgery, vascular surgery, rehabilitation

and geriatrics. The activity of the SU needs to be continuous

over 24 h/day; the physical presence of a neurologist on duty is

a requirement (9). Further, it is recommended that the SU

facilities include multiparameter noninvasive monitoring

(EKG, oximetry, blood pressure and body temperature),

together with a laboratory for blood analytic measurements

as well as ultrasound for neurovascular assessment (transcra-

nial and extracranial Doppler sonography) (7–10).

Since the 1950s, there have been several studies conducted

with the objective of establishing an appropriate organiza-

tional model for stroke, focusing on aspects of rehabilitation

(7). It was not until the 1970s that the idea of the SU was

suggested for the first time. Initially, these were designed as

intensive care units (ICUs), with facilities for monitoring and

for the administration of intensive therapy. The patients

admitted were those with severe stroke, with greater neurolo-

gical deficit and poorer general status. Those with mild

impairment or with a transient ischemic attack (TIA) were

excluded. The results were very variable and did not show a

clear reduction in mortality, although decreases in the num-

bers of complications were noted (11–15) (Table 1)

Subsequently, in the 1980s, the concept of the SU evolved

from acute, nonICUs characterized by a systemization of care

provision for the patients and that involved trained personnel,

preestablished criteria, with special attention being paid to the

acute-phase treatment and the early functional rehabilitation

and early return to society. This implied establishing a

systematic diagnosis and precise therapy as well as an effica-

cious multidisciplinary approach. In the 1990s, interest in SUs

was renewed following the publication of several studies

comparing SUs with general medical wards that demonstrated

the benefits in terms of mortality, functional recovery and in

the rates of chronic institutionalization (16–19) (Table 1).

Also, several meta-analyses confirmed the efficacy of SUs not

only with respect to early mortality (28% reduction within the

first 4 months) but also that at 1 year (21% reduction) (20).

There was a reduction in the odds of death [odds ratio (OR)

0�86; 95% confidence interval (CI) 0�71–0�94], in the odds of

death or institutionalized care (OR 0�80; 95% CI 0�71–0�90)

and in the odds of death or dependency (0�78; 95% CI 0�68–

0�89) (21). This means that the number needed to treat to

prevent one death was 33, to prevent one patient being unable

to live at home was 20 and to prevent one patient failing to

regain independence was 20 (21).

Despite the grade I evidence of the efficacy of SUs based on

randomized studies and meta-analyses, there has not been a

generalized implementation of SUs, in contrast to that which

occurred with specialized coronary care units. We intend to

provide responses to the different questions raised regarding

the practical utility of SUs. These include: are they effective in

the management of stroke and are the benefits reproducible in

standard clinical practice? Are there alternative models? Who

benefits? Are SUs cost-effective? Is efficacy consistent within

the time of operation? Is the effectiveness comparable to other

therapeutic measures in the management of stroke patients?

How can the outcomes be improved? For this purpose, a

nonsystematic review of published studies that have specifi-

cally addressed any of those points of controversy or that have

added relevant knowledge to those questions was conducted.

Are SUs efficacious in the management of acutestroke and are the benefits reproducible in standardclinical practice?

One of the most consistent benefits demonstrated in the

randomized studies is the reduction in mortality, which is

clearest in the analysis of early mortality (5 days to 6 weeks), the

most frequent cause of death being pneumonia, recurrent

stroke and pulmonary embolism. In the first week following a

stroke, there are no significant differences with respect to the

effect of SU. This is probably due to the fundamental cause of

death in this period being directly related to the severity of the

stroke and is not modifiable by any specific therapeutic

intervention. From about 5 days onwards, however, a signifi-

cant reduction in mortality is observed in the patients receiv-

ing attention in the SU compared with those receiving

attention in the general medical ward (18, 19). Further, the

results of follow-up over 5–10 days of patients attended to in

the SU compared with the general medical ward show a higher

long-term survival in the former, and that this reduction in

mortality is maintained from the first 6 weeks. This indicates

that it is the treatment in the acute phase in the SU that

determines the better prognosis of the patients (22–24).

Another important aspect to consider is the neurological

recovery of the patients, because stroke is one of the principal

causes of adult dependency. The studies that analyzed this

aspect have shown that the functional status at discharge from

hospital improves in those patients attended to in the SU

compared with those in the general medical ward (18, 22–24).

& 2009 The Authors.Journal compilation & 2009 World Stroke Organization International Journal of Stroke Vol 4, February 2009, 28–37 29

B. Fuentes & E. Dıez-Tejedor Topical review

Page 3: Stroke units: many questions, some answers

This, together with the reduction in mortality, is the most

important benefit obtained with the SUs i.e. increase in

survival at the cost of a greater proportion of patients being

dependent would be a poor outcome for the SU.

Once the advantages of the care provision in the SU have

been demonstrated, the factors that determine these benefits

need to be evaluated, and whether the benefits observed in the

randomized studies can be reproduced in standard clinical

practice. In the Stroke Care Outcomes: Providing Effective

Services (SCOPES) study, a prospective single-blind multi-

center study conducted in Australia, the adherence to a selected

set of clinically important processes of care, which included

aspects of care within 24 h of admission, documentation and

general management, was analyzed in three models of stroke

care (equivalent to SU, STand general medical care). The main

findings were that the adherence to those predefined processes

of care was associated with improved survival at discharge and

that adherence to those processes of care was higher in SU than

in other models (25). Similarly, in the PROSIT study per-

formed in Italia, a higher quality in terms of infra-structure

and organization in terms of diagnosis and the processes of

care was found in the SU group. However, the effects of these

components on the efficacy and effectiveness of stroke treat-

ment had not been analyzed sufficiently in this last study (26).

In 1997, the Cochrane meta-analysis, based on the observa-

tions of deaths from the illness, suggested that the benefits of

the SU are related to a reduction in the secondary complica-

tions of the stroke, especially the relationship with the hospi-

talization of the patient i.e. the majority of the deaths avoided

by the SU correspond to weeks 1–4 following the stroke (27). It

has been highlighted that an early commencement of patient

mobility and rehabilitation, together with stabilization of

Table 1 Nonsystematic selection of studies that compared models of care provision for stroke

Intensive care stroke units

Kennedy et al. (11) Prospective

Randomized

No differences in mortality; reduction in complications

Drake et al. (12) Retrospective

Nonrandomized

No differences in mortality; reduction in complications; trend toward reduction in

long-stay hospitalization

Pitner and Cornelius (13) Prospective Not effective with respect to mortality

Norris and Hachinski (14) Prospective

Nonrandomized

Not effective with respect to mortality

Intermediate care stroke units

Strand et al. (16, 17) Prospective

Randomized

Reduction in medium-stay hospitalization

Reduction in hospitalization in long-stay centers

Indredavik et al. (18, 22, 23) Prospective

Randomized

Reduction in mortality

Reduction in medium-stay hospitalization

Better functional status

Reduction in hospitalization in long-stay centers

Patient follow-up for between 5 and 10 years: persistent benefit in mortality and

functional status

Stroke teams

Wood-Dauphinee et al. (49) Randomized

General medical

No significant efficacy

Webb et al. (47) Prospective

Historical controls

Reduction in medium-stay hospitalization

Reduction in morbidity (k urinary infections)

Dey et al. (50) Prospective

Randomized

Premature termination of the study

No significant differences in mortality at 6 weeks or at 12 months

Stroke units vs. neurology ward

Krespi Y et al. (37) Before and after study Reduction in in-hospital case-facility

Shorter length of stay

Stroke units vs. stroke teams

Kalra et al.(51)

Evans et al. (32)

Randomized

Three groups:

– Stroke unit

– Stroke team

– Home care

Reduction in mortality at 3, 6 and 12 months

Better functional status at 3, 6 and 12 months

Reduction in complications

Dıez-Tejedor and Fuentes (30)

Fuentes et al. (70)

Prospective

Historical controls

Neurological setting

Better functional status at discharge

Reduction in medium-stay hospitalization

Reduction in complications

Reduction in long-stay hospitalization

Reduction in health costs

Consistent benefits with respect to function

Cadilhac and Ibrahim (25) Prospective

Single blind

Higher rates of adherence to key processes of care in SU than in other models

SU, stroke units.

& 2009 The Authors.30 Journal compilation & 2009 World Stroke Organization International Journal of Stroke Vol 4, February 2009, 28–37

Topical review B. Fuentes & E. Dıez-Tejedor

Page 4: Stroke units: many questions, some answers

blood pressure, were the most important aspects in the health

care provision in the SU (28). In an observational study in

which the clinical evolution of the patients with acute stroke

in the SU was compared with historical controls attended to by

STs within the same department of neurology, the better

attention to the overall care of the patient with a reduction

in complications (systemic and neurological) was found to be

independent good prognostic factor not only with respect to

mortality or dependence but also chronic hospitalization (29–

31). Further, a post hoc analysis of a randomized study that

compared SU vs. ST concluded that the differences in the

management of the patients (with respect to the diagnostic

procedures and therapeutics) and the reduction of complica-

tions were the two factors that determine the greater efficacy of

the SU compared with the ST (32). The importance of SUs in

the reduction of complications, especially of infections and of

mortality associated with them, has been confirmed recently in

a systematic review (33).

Hence, it is evident that, apart from the organizational

differences, one of the fundamental aspects of the SU is the

specialized management of the patient in the acute phase,

especially with regard to overall care, with strict control of the

blood pressure, temperature, glycemia, oxygen saturation and

prevention of complications. Maintenance of homeostasis in

this phase has a direct impact on functional prognosis in the

short term (31, 34). Differences in the management of these

physiological parameters of the patients in acute phase deter-

mine, in great part, the different stroke-related mortality rates

in different countries (35). Further, the benefits of SUs are

reproducible in standard clinical practice and result in an

increase in patient transfer to home care and improvement in

functional status (29, 30, 36–38).

Are there alternative models for care provisionfollowing stroke?

� Nonneurological care: The majority of SU trials were

conducted in nonneurological wards and the benefits when

compared with general wards without specific stroke care

programs is clear. To date, there exist some controversies

regarding which medical specialist should manage acute stroke

patients (39–41). However, there are some studies suggesting

that specific neurological care could provide additional ben-

efits to stoke patients. Already in 1995 a randomized study that

compared the efficiency of the Neurology Department vs. that

of Medicine demonstrated a mean reduction in hospital stay,

improved the functional status at discharge from hospital and

an increase in the number of patients capable of returning

home in the group that was attended to in the neurology ward

(42). This was reinforced by a multicenter study of the Spanish

Stroke Study Group, which demonstrated that early care

(within the first 6 h) by the neurologist was related to a better

functional prognosis and shortening of hospital stay (43).

Other observational studies have shown better outcomes in

patients treated by neurologists as compared with other

specialists (44–46). Thus, in our opinion, although a multi-

disciplinary approach is the basis of SU care, neurologists

should have a key role in SU organization as it is recommended

by some societies (8, 9). In fact, in many countries in Europe,

SUs are predominantly set up in neurological departments (1).

� Stroke teams (STs): These are defined as multidisciplinary

teams available for the care of stroke patients in any hospital

environment. Generally, this would be composed of one or two

neurologists, a physiotherapist or occupational therapist and a

nurse specialized in care of the stroke patient. There have been

few studies conducted to assess the efficacy of STs. Initial

studies highlighted a benefit of STs in relation to the mean

reduction in hospital stay and in morbidity (decrease in

urinary infections) (47). Subsequent observational studies,

randomized trials and meta-analyses (29, 51, 48) that com-

pared STs with general medical wards (49, 50) and with SUs

(30) confirmed that the STs are not an effective alternative in

the care provision for patients with acute stroke (21, 52, 53).

Nevertheless, in those centers in which it is not feasible to set up

SUs, the ST could be considered as a valid organizational option

but always with the premise that those ST be integrated in a

Stroke care network with tight collaboration with a reference

center with an SU (Comprehensive Stroke Centre) (54).

� Care pathways: There have been, over the past few years, new

tools of clinical administration developed of note, among

which are clinical decision trees. This deals with care-provision

plans that define and regulate sequences of health-care activ-

ities or interventions for a defined group of patients with a

predictable clinical course and whose principal objective, is to

provide quality care for the patient based on the best scientific

evidence available. A further objective is to avoid the inter-

individual variation between health-care professionals. When

analyzing its efficacy in general neurology wards, set up as

an alternative to SUs, there were no benefits observed with

respect to the management of the patients whereas, conversely,

there was a trend towards a poorer clinical evolution of the

patient (55).

Which patients benefit from care in SUs?

Starting from the premise that, to achieve a benefit, all patients

with stroke, independent of severity, age or comorbidity

should be attended to in SUs, it is clear that on many occasions

the resources available in the SU, especially with respect to bed

availability, are limited. A health-care political priority would

be to select those patients who may benefit from SU attention.

Hence, in the studies published on SUs, there has been, with

disturbing frequency, a search for a patient profile that would

best benefit from the specialist attention. To date, there have

been analyses based on the severity of the stroke, age of the

patient, presence of comorbidity and stroke sub-type.

Analysis of the clinical evolution of the stroke patient

attended to in the SU compared with the general medical

ward with respect to age and grade of neurological involvement

have highlighted the presence of hemiparesis on admission to

& 2009 The Authors.Journal compilation & 2009 World Stroke Organization International Journal of Stroke Vol 4, February 2009, 28–37 31

B. Fuentes & E. Dıez-Tejedor Topical review

Page 5: Stroke units: many questions, some answers

hospital and advanced age as factors determining mortality

and/or dependency. The effect of age depends on the moment

in which its impact is evaluated. For example, patients o75

years of age are those that benefit most from attention in the SU

in the short term because this attention accelerates the patient’s

neurological recovery; in the long term, however, the recovery

will be the same if the patient was attended to in the general

ward. Conversely, in patients 475 years of age, the differences

are modest initially but become statistically significant in favor

of the SUs in the years following the stroke (17). Another

circumstance that has been considered is the presence of

comorbidity especially in relation to the presence of concur-

rent heart disease i.e. patients with cardiac disease benefit more

at 3 months in terms of mortality and/or institutionalization

when attended to in SUs (17, 56).

The Cochrane meta-analysis of 2002 analyzed the differ-

ences between sub-groups of patients. The main conclusion

was that the benefits observed with the organized care and

specialized for stroke were not confined to a specific patient

sub-group. The analysis highlighted that clear benefits were

obtained in patients of either gender, of different age ranges

and independent of the grade of neurological involvement. The

more severe stroke patient groups have a higher mortality risk

inherent in the severity of the stroke, and are those patients who

benefit most in terms of mortality or dependency rates, the

benefit being less evident when mortality and institutionalized

care were assessed (21). Also of note is that patients with

preexisting functional dependency were not included in rando-

mized studies on SU but data from observational studies suggest

that they do not obtain a clear benefit from SU attention (57).

With respect to the stroke type, a few authors have analyzed

the possible differences in the benefits from SU care in terms of

mortality and functional recovery, despite the known differ-

ences in prognoses. In a post hoc analysis of a randomized trial

that compared SU against ST and home care, the prognostic

differences and associated costs were evaluated in patients with

nonlacunar cerebral infarction (CI) compared with patients

with lacunar strokes attended to in the SU vs. those receiving

ST attention in the general ward. In the group of patients with

large-vessel CI, attention provided by the ST was associated

with higher mortality probability at 3 months and at the end of

1 year and also mortality and institutionalization. In the group

with lacunar infarction, no significant differences were ob-

served in the prognosis at 3 months or at 1 year between the

two organizational models. However, there were higher costs

resulting from an increase in the mean hospital stay and greater

use of resources (physiotherapy, occupational therapy and

logopedia) (58). Nevertheless, the patients with lacunar strokes

benefited from SU attention as well, with a reduction in

complications and hospital stay apart from achieving a better

functional status at discharge from hospital. The significant

increase in patient independence was clearer in the multi-

variate analysis in which being treated in the SU was an

independent factor for a better prognosis with respect to the

dependency variable (59).

In relation to cerebral hemorrhage (CH), there have been

few studies that have specifically evaluated the benefits of SU in

the management of CH. The possible benefit (mortality

reduction) in the patients with CH attended to in the SU

compared with those in the general medicine ward and

compared with those receiving attention in the ST in the

neurology ward was noted for the first time in 1998 (60). The

study demonstrated a reduction in complications, mean

hospital stay and improvement in functional status associated

with the SU. Subsequently, in a controlled prospective study in

which 121 patients with stroke were randomized to an SU or to

a general medical ward, a significant decrease in mortality at

30 days and at 1 year was found in favor of the SU (61).

The majority of the studies that analyzed the efficacy of SUs

or STs did not include patients with TIA, and there are few

studies on the short-term prognosis or the diagnostic and

therapeutic implications of care provision for TIA. In observa-

tional studies, care provision for patients with TIA in the SU

was associated with a reduction in the mean hospital stay,

health-care costs and improved diagnostic efficiency com-

pared with those attended to in the same neurology ward by the

ST (29) with earlier application of specific treatments (62).

In summary, all the patients with acute stroke, independent

of age, severity, cardiac comorbidity or stroke sub-type, benefit

from care provision in SUs.

Are SUs cost-effective?

Taking into account elevated health-care costs and limitations

on resources, it is necessary to identify care-provision models

that are not only efficacious but also efficient. The costs of

acute stroke derive from hospital costs while, in the long term,

the costs are related mainly to the grade of the residual

incapacity of the patients. Direct costs are those derived from

the use of the health service resources (drugs, nursing care,

rehabilitation, y) and indirect costs are those that are implied

in the loss of productivity of the subject who has suffered a

stroke. At the time of assessing those with stroke, we need to

consider different variables: those in the acute phase, funda-

mentally attributable to hospital costs and directly related to

the mean hospital stay, and those of the long term, which are

derived from the care of the patient with functional depen-

dency requiring rehabilitation, short-stay hospitalization,

long-stay hospitalization, home care, etc (63). Clearly, the

care organization model that shows a reduction not only in the

mean hospital stay but also in the percentage of patients with

dependency at discharge from hospital can be considered as the

more cost-effective system.

The care provision in the several models of SU (acute care,

rehabilitation or mixed) is associated with a reduction in the

mean stay in hospital, despite the heterogeneity in the calcula-

tion of this variable (hospitalization in the acute phase, overall

duration of hospitalization and long-stay institutions) as

demonstrated in individual studies and in systematic reviewers

(16, 21, 29–30, 37, 47, 64–66). This reduction in hospital stay is

& 2009 The Authors.32 Journal compilation & 2009 World Stroke Organization International Journal of Stroke Vol 4, February 2009, 28–37

Topical review B. Fuentes & E. Dıez-Tejedor

Page 6: Stroke units: many questions, some answers

associated with a reduction in hospital costs (30). Further, SU

care achieves an increased transfer to home care with less long-

term hospitalization (16–19, 27, 29, 30). Further, if we consider

that the SU improves the functional status at discharge from

hospital and that fewer patients are discharged to home-care

with physical dependencies, we observe a greater effectiveness

of SU, whose repercussion is a reduced burden on family and

on society.

With respect to the cost-effectiveness from the point of view

of the health economy, it has been highlighted over the past

few years that SU implementation has an increased cost due to

the increase in personnel and of the diagnostic/therapeutic

procedures, which reach 7% of the cost of the admission to

hospital and 15�6% if we consider the mean costs per day

of admission to general neurology wards (67). However,

although the costs related to resource use are generally higher

in SU as compared with conventional care, but similar to

mobile service, when outcomes are included in the analysis, SU

appears to be more cost-effective than either mobile stroke

teams or general medical care because of the potential health

benefits that can be achieved (68).

On the other hand, with the objective of calculating the

clinical and economic consequences of establishing SUs com-

pared with conventional care, the study conducted by Launois

et al. (69) in France is of considerable interest. Focusing

essentially on administration, the authors performed an

analysis in which the important variables included were the

grade of incapacity of the patients, the destination on discharge

from hospital and probability of stroke recurrence. These

variables were in addition to those usually considered in

economic studies on care provision such as the probability of

death or survival and the specific model of care provision. As

such, the study could be considered as the most comprehensive

cost-effectiveness study of stroke care provision conducted to

date. The study not only confirmed that the SU results in a

higher patient survival rate without sequelae in the 5 years of

follow-up but also, and more significantly from the perspective

of the administrative process, the SU cost-effectiveness ratio is

much lower than the threshold of acceptability recognized by

the scientific community. This finding justifies, as highlighted

by the authors of the study, the need for organizational changes

in the care provision for stroke patients, and that it is essential

that SUs are established in France. Certainly, these data cannot

be extrapolated to other countries but they do provide

important departure points, demonstrating, from the clinical

administration perspective, that the SUs are superior to

conventional care not only in terms of efficacy but also cost

i.e. the implementation of such units is clearly justified.

Are the benefits of SUs consistent over the time theyhave been in operation?

The majority of long-term studies performed have focused on

the follow-up at 5–10 years of patients initially attended to in

SUs. The authors of these studies demonstrated high survival

rates in the long term and an increase in the patient’s capacity

to return home (22–24). However, what remains to be

determined is whether the efficacy of the SU is maintained

over the period in which the SUs have been operating. This

question is of considerable importance because a possible bias

in the analysis of efficacy of a new organizational model is the

motivation and enthusiasm of those health-care professionals

involved in the initial implementation of such units. Further,

almost all randomized trials compared SUs with the attention

provided to stroke patients in other non-specific wards in

which the personnel did not follow the same protocols or

guidelines for the management than in the SU groups. As such,

some of the favorable results observed for SUs could be a

reflection of the greater dedication and specific care provided

by the SU personnel (7). Thus, the good outcomes not only in

the acute phase but also in the subsequent follow-up of the

patients in these studies could be due to the differences in the

clinical management related to each of the care-provision

models during the hospitalization phase, and not due to a real

benefit of the SU per se. The response to this criticism is that an

analysis has been performed of the functional status at 8 years

of the SU that demonstrated that the benefits of the SU in terms

of reductions in the mean hospital stay, mortality/dependency

and institutionalization were maintained over the period of 8

years analyzed and that, indeed, over the last few years, further

reductions in the mean hospital stays, intrahospital complica-

tions and a higher percentage of survival have been achieved

(70). As such, as with the health-care personnel and diagnostic

protocols/therapies, it is the specific attention provided in the

SU that determines the good results, and that have been

consistent over the time they have been in operation.

Is SU effectiveness comparable to othertherapeutic measures in the managementof stroke patients?

In 1999, Hankey and Warlow published an analysis of the

effectiveness of the different treatments available for acute-

phase CI, such as aspirin, fibrinolytic treatment tissue-type

plasminogen activator (rt-PA) and attention received in SUs.

The authors considered the impact of the application of these

treatments at the level of the community and on the overall

stroke load. Although thrombolysis would be the therapeutic

measure with the best numbers needed to treat (NNT; 16 for

thrombolysis vs. 18 for SU and 83 for aspirin), the analysis of

mortality and/or dependencies avoided showed 8�3% for SU

vs. 1�2% for thrombolysis and 1�8% for aspirin (Fig. 1) (71).

The cost-effectiveness analysis highlighted that the SUs are

highly cost-effective because they achieve an absolute benefit

similar to thrombolysis but can be applied to greater numbers

of patients (71). These data have been confirmed in a study

conducted by Gilligan and colleagues in which the eligibility of

the different specific treatments available (including further

hypothetical data on neuroprotection deduced from clinical

trials) was analyzed in a group of acute-stroke patients

& 2009 The Authors.Journal compilation & 2009 World Stroke Organization International Journal of Stroke Vol 4, February 2009, 28–37 33

B. Fuentes & E. Dıez-Tejedor Topical review

Page 7: Stroke units: many questions, some answers

attended to in the hospital, and the results were extrapolated

to the general population. Of the patients, 83% would

be candidates for management in a specialized SU, 40% to

treatment with aspirin in the first 48 h and only 10% to

intravenous thrombolysis with rt-PA in the first 3 h (Fig. 1).

The authors concluded that greater benefit to the community

is achieved with SUs and that although all these therapeutic

measures should be accessible to the acute-stroke patients,

access to the SU needs to be considered a priority (72).

How can we improve the results of the SUs?

� Monitored SUs: Over a considerable period of time, the early

rehabilitation has been considered as the most important

component and determinant of efficacy. However, the study

by Indredavik et al. (28) highlighted the possible influence of

general care, particularly in relation to the control of blood

pressure and the early treatment of hypothermia; the impor-

tance of maintaining homeostasis of the patients is becoming

progressively more evident in terms of short-term prognosis

(34) and the reduction in the complications (30, 32, 33, 73).

These beneficial effects have been demonstrated in the SU in

which vital signs are noninvasively measured four times daily.

Over the past few years, several studies have been published

highlighting the importance of continuous monitoring of

these parameters and the implication in the patient’s prognosis

and have demonstrated lower mortality rates at 3 months (74)

and at 1 year (75). This benefit is probably due to a better

detection of complications (cardiac events, fever, hyperten-

sion, hypotension and hypoxia) in the monitored patients and,

hence, a more rapid deployment of appropriate therapy.

Because a lack of a properly designed study of conventional

SU with physiological variable measurement (blood pressure,

cardiac frequency, body temperature and oxygen saturation)

four times a day compared with SUs with continuous mon-

itoring of these same variables, there continues to be consider-

able controversy on the convenience and/or the desirability of

SUs with continuous monitoring (76–78). Currently, the cost

on continuous monitoring in SUs is advisable, but it is not vital

to implement a new SU in such a manner that the cost of

acquiring noninvasive monitors does not convert to being

inconvenient, being sufficient to monitor these vital signs

clinically because only this model of SU (nonmonitored) has

demonstrated cost-effectiveness in randomized trials.

� Care pathways: There have been several studies on the

implementation of care pathways of administration in the

care provision of stroke patients. These have focused on aspects

of rehabilitation and without analyzing the impact of these

clinical routes on acute-phase stroke. The emphasis has been

on increasing the diagnostic tests and reducing the risk of

urinary infections, and of re-hospitalization. However, there is

insufficient scientific evidence regarding their benefits in the

prognosis of vital function and status. As highlighted by the

Cochrane reviews (79–81), this is due to methodological

limitations such as a nonrandomized design in the majority

of trials. Only one study with historical controls had analyzed

the impact of the introduction of a new stroke care pathway in

an acute SU. The study showed a greater quality in the process

of diagnosis and a reduction in the urinary infection as an

intrahospital complication (82). Further, the care pathways

specifying the day-to-day diagnostic and therapeutic measures

that need to be applied to the stroke patients assure a continued

quality of care provision. The process should also include

greater monitoring and follow-up on weekends and holidays.

Admission into the SU on the weekend or in vacation periods

has been shown to be associated with a higher mortality rate

and poorer functional recovery, which can be attributed to

decreased numbers of clinical personnel, a lower multidisci-

plinary treatment intensity and a delay in the rehabilitation

process (83, 84). Hence, it is necessary to ensure continuous

care in the SU that includes not only an adequate proportion of

nursing care but also continuity in the diagnostic processes,

together with physiotherapy and rehabilitation, including on

weekends and holidays.

Final considerations, SUs: scientific and socialdemand

Since 1995, the World Health Organization (WHO) and

the European Stroke Committee have implemented the

10%Intravenous thrombolysis

NNT 16

Target population

AspirineNNT 83

80%

40%

Stroke UnitsNNT 18

Fig. 1 Effectiveness of the different treatments available for acute phase confidence interval (CI).

& 2009 The Authors.34 Journal compilation & 2009 World Stroke Organization International Journal of Stroke Vol 4, February 2009, 28–37

Topical review B. Fuentes & E. Dıez-Tejedor

Page 8: Stroke units: many questions, some answers

Declaration of Helsingborg in which it was specified, as an

objective to be achieved by the year 2005, that all stroke

patients in the acute phase should have an early, and specia-

lized, evaluation and treatment in an SU. In the year 2006, the

revised Declaration of Helsingborg declared that by the year

2015 ‘all patients in Europe with stroke will have access to a

continuum of care from organized SU in the acute phase, to

appropriate rehabilitation, and to secondary prevention mea-

sures’ (85). Neurology scientific societies insist on the need to

establish SUs in the majority of hospitals, the option of STs

being acceptable only when it is not possible to implement

SUs (86–91).

Based on the scientific evidence, specialized neurology care

provision for stroke patients is not only a necessary and cost-

effective facility but also a social demand (92). As such, for

example in Spain, the Associations of Neurological Diseases

and the Spanish Society of Neurology [Sociedad Espanola de

Neurologıa] developed the ‘Madrid Declaration’ [Declaracion

de Madrid] in 2000, which proclaimed ‘the right of all citizens

to receive attention by an expert with specialist competence in

the different neurological pathologies, to have access to up-to-

date diagnostic and therapeutic techniques, and to be attended

to by specific interdisciplinary units in which they can obtain

all the help necessary for their health problem, with guarantees

of it being the best quality possible’ (93). More recently, the

Defensor del Pueblo in his report on overcoming cerebral

damage, recommended that the Health Authorities should

emphasize the early and specialized care for stroke patients by

creating specialized SUs to provide sufficient cover for the total

population (94). A questionnaire conducted among 1713

stroke patients receiving attention in hospitals in the United

Kingdom had a higher percentage of satisfaction with the

language and communication skills of the carers, with the basic

activities such as hygiene and alimentation, together with the

planning of care, rehabilitation and physiotherapy at discharge

from hospital as well as a greater confidence in the health-care

personnel (95).

In summary, the SU is the most efficacious care organization

model for acute stroke, even in comparison with STs. All

patients suffering from a stroke can benefit from attention

in the SU. These units are efficient and cost-effective, and

consistent over the time period of their operation. When the

community benefits of the different specific treatments for

stroke such as aspirin and intravenous thrombolytic agents are

considered, the SUs have a higher target population potential

and a higher benefit in terms of numbers of deaths or

dependencies avoided. As such, the SU is a necessary care-

provision facility that is also cost-effective.

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