Brief Psychosocial–Behavioral Intervention With
Antidepressant Reduces Poststroke Depression Significantly
More Than Usual Care With Antidepressant
Living Well With Stroke: Randomized, Controlled Trial
Pamela H. Mitchell, PhD; Richard C. Veith, MD; Kyra J. Becker, MD; Ann Buzaitis, MN;
Kevin C. Cain, PhD; Michael Fruin, MN; David Tirschwell, MD, MSc; Linda Teri, PhD
Downloaded from http://stroke.ahajournals.org/ by guest on June 18, 2017
Background and Purpose—Depression after stroke is prevalent, diminishing recovery and quality of life. Brief behavioral
intervention, adjunctive to antidepressant therapy, has not been well evaluated for long-term efficacy in those with
poststroke depression.
Methods—One hundred one clinically depressed patients with ischemic stroke within 4 months of index stroke were
randomly assigned to an 8-week brief psychosocial– behavioral intervention plus antidepressant or usual care, including
antidepressant. The primary end point was reduction in depressive symptom severity at 12 months after entry.
Results—Hamilton Rating Scale for Depression raw score in the intervention group was significantly lower immediately
posttreatment (P⬍0.001) and at 12 months (P⫽0.05) compared with control subjects. Remission (Hamilton Rating
Scale for Depression ⬍10) was significantly greater immediately posttreatment and at 12 months in the intervention
group compared with the usual care control. The mean percent decrease (47%⫾26% intervention versus 32%⫾36%
control, P⫽0.02) and the mean absolute decrease (⫺9.2⫾5.7 intervention versus ⫺6.2⫾6.4 control, P⫽0.023) in
Hamilton Rating Scale for Depression at 12 months were clinically important and statistically significant in the
intervention group compared with control.
Conclusion—A brief psychosocial– behavioral intervention is highly effective in reducing depression in both the short and
long term. (Stroke. 2009;40:3073-3078.)
Key Words: behavioral therapy 䡲 depression 䡲 randomized controlled trial 䡲 stroke
D
epression is a serious sequelae of strokes of all types,
affecting at least 33% of stroke survivors.1 Poststroke
depression (PSD) has been associated with poor recovery and
rehabilitation response,2– 6 reduced social functioning and
delayed return to work,7–9 greater use of healthcare services,10
and increased risk of subsequent cardiac and stroke events as
well as increased mortality from all causes.2,11,12
Antidepressants have demonstrated varying degrees of
efficacy when tested over short follow-up periods. A recent
Cochrane Review concluded that although mood was improved in many antidepressant drug studies, there was no
clear evidence of remission (no longer meeting entry depression criteria) or response (ⱖ50% reduction in depression
score) in the short or long term.13 In contrast, a meta-analysis
of 16 randomized, controlled trials showed definite overall
improvement in PSD in those taking a variety of antidepressants compared with placebo.14 Only recently have there been
well-designed trials of nonpharmacologic treatments, both
showing important reductions in PSD short term (3
months).15,16 We believe ours is the first to report clinically
and statistically important reduction in depression over the
long term.
Methods
Design
Living Well With Stroke (LWWS) was a randomized treatment
efficacy study with usual care control comparing brief psychosocial–
behavioral intervention plus antidepressant with usual care and
antidepressant.17 The study was approved by the University of
Washington Human Subjects Division (Institutional Review Board)
for protection of human subjects.
The primary aim was to determine the effect of a nurse-delivered
psychosocial– behavioral intervention on depression in communitydwelling poststroke patients. The primary hypothesis was that
patients with PSD provided a 9-session problem-solving, pleasant
Received February 6, 2009; final revision received March 3, 2009; accepted March 11, 2009.
From the Departments of Biobehavioral Nursing and Health Systems (P.H.M., A.B., M.F.), Psychiatry and Behavioral Science (R.C.V.), Neurology
(K.J.B., D.T.), Biostatistics (K.C.C.), and Psychosocial and Community Health (L.T.), University of Washington, Seattle, Wash.
Preliminary results were presented at the 2008 International Stroke Conference with the abstract published in Stroke: Podium presentation ISC
published as Mitchell PH, Becker KJ, Buzaitis A, Cain KC, Fruin M, Kohen R, Teri L, Tirschwell D, Veith R. Brief psychosocial/behavioral intervention
with antidepressant reduces post-stroke depression significantly more than antidepressant alone. Stroke. 2008;39:543.
Correspondence to Pamela H. Mitchell, PhD, Box 357266, University of Washington, Seattle, WA 98195-7266. E-mail [email protected]
© 2009 American Heart Association, Inc.
Stroke is available at http://stroke.ahajournals.org
DOI: 10.1161/STROKEAHA.109.549808
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Stroke
September 2009
Figure. LWWS flowchart.
Downloaded from http://stroke.ahajournals.org/ by guest on June 18, 2017
events intervention in addition to antidepressant treatment would
have significantly reduced depression severity (Hamilton Rating
Scale for Depression [HRSD]) at 12 months poststroke compared
with patients with PSD with usual care, including antidepressant
treatment.
The secondary aims were to describe the time course for reduction
in depressive symptoms and to determine the intervention effect on
secondary end points: limitations in ability (physical function),
limitation in participation, and overall stroke impact.
Participants
Participants were 101 patients within 4 months of an ischemic stroke,
verified by CT or MRI, who screened positive for depressive
symptoms and whose diagnosis of clinical depression was verified
by a diagnostic interview using Diagnostic and Statistical Manual of
Mental Disorders, 4th Edition criteria.18 Participants were not
excluded for prior or current treatment for depression.
Study Protocol
Depression Screening
Patients hospitalized in 4 acute care hospitals in Seattle, Wash, were
screened for depression with the 30-item Geriatric Depression
Scale.19 The diagnosis of depression was validated by the Diagnostic
Interview and Structured Hamilton18 in those who scored ⱖ11 on the
Geriatric Depression Scale and consented to the full study.
Psychosocial–Behavioral Intervention and Usual Care
All participants were given written stroke recovery materials from
the American Stroke Association, including information about depression. They completed a medication diary each of the first 8
weeks of the trial. These diaries were either mailed to the research
coordinator (usual care) with reminder telephone calls or brought to
the counseling session (psychosocial– behavioral intervention). All
participants saw their stroke care or primary care provider for
ongoing medical care, including adjustment of antidepressant medication, as scheduled by that provider.
Those randomized to the psychosocial– behavioral intervention
met with a study interventionist 9 times over 8 weeks. Sessions were
focused on the individual; however, a participant could opt to have
a family member or informal caregiver join these sessions. Fifteen
caregivers joined sessions and provided data. The brief psychosocial– behavioral intervention was adapted from the “Seattle Protocols,” shown to reduce disability associated with depression in
Alzheimer disease.20
Although antidepressant treatment is often provided to patients
with PSD as a community standard, we reasoned that without
behavioral change, there would not be a long-lasting change from the
initial mood elevation seen with antidepressants. We used language
pertinent to stroke and taught participants to view depressive
symptoms as observable and modifiable behaviors that are initiated
and maintained by person– environment interactions. The treatment
goal was to increase the level of pleasant social and physical activity
to improve mood. Specific problem-solving approaches were taught
and solutions to behavioral challenges were individualized to each
person. The content of these sessions is more fully outlined in our
design publication17 and in the treatment manual available from the
first author.
Usual Care Arm
Participants in the usual care arm saw their stroke care or primary
care provider as scheduled by that provider. When used, antidepressant medication was prescribed and adjusted by the usual care
provider. Twenty-five caregivers joined the stroke survivor in this
arm. We did not design an arm with equivalent time and attention but
without the depression content because the Seattle Protocol trials had
Mitchell et al
Table 1.
Brief Psychosocial–Behavioral Intervention Reduces PSD
Baseline Demographic Characteristics
Characteristic
Intervention (N⫽48)
Table 2.
Control (N⫽53)
29
Female
Age, years (mean, range)
Intervention (N⫽48)
NIHSS score, mean (SD, range)
6.08 (4.4, 0 –17)
6.21 (5.05, 0 –17)
32
HRSD, mean (SD, range)
20.0 (4.53, 10–29)
19.8 (4.15, 11–29)
Barthel Index, mean (SD)
81.9 (23.2)
83.5 (22.3)
Perceived percent recovery,
mean (SD, range)
46.3 (23.1, 0–90)
55.3 (19.7, 10–100)
19
21
57 (25–88)
57 (29–88)
7
8
Marital status
Single
Married, partnered
19
22
Widowed, divorced, separated
22
23
Current living arrangement
Alone
4
3
With spouse, partner, roommates
22
24
With other relatives
13
17
9
9
Group housing
Control (N⫽53)
History of depression
75%
69.8%
Currently taking antidepressant
medication
60.4%
64.2%
Left hemisphere stroke
37.5%
52.8%
Right hemisphere stroke
62.5%
47.2%
Hypertensive medication
81.3%
75.5%
Heart disease: congestive failure
10.4%
13.2%
Diabetes
16.7%
43.4%
NIHSS indicates National Institutes of Health Stroke Scale.
Race, ethnicity
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Hispanic
Baseline Stroke and Health Characteristics
Characteristic
Gender
Male
3075
3
2
More than one race
12
10
White only
29
35
Black only
3
7
0
Japanese only
3
Pacific Islander only
0
1
Korean only
1
0
already demonstrated that an “attention control” as well as a waiting
list control had significantly less improvement in depression than did
the active intervention, similar to other problem-solving interventions in multiple populations.17,21
Antidepressant Recommendation
Selective serotonin reuptake inhibitor antidepressant treatment was
an informal standard of care in this community at the inception of
this study. Therefore, the participant’s own provider prescribed the
selective serotonin reuptake inhibitor or an alternate antidepressant
based on his or her own assessment and recommendation provided
through a letter sent to each participant’s provider. The study
psychiatrist (R.V.) recommended sertraline as an initial antidepressant choice due to its tolerability in the setting of medical illness and
a relatively lower incidence of cardiovascular side effects.
Study Timetable and Assessments
A full baseline data set, including demographics, stroke characteristics, National Institutes of Health Stroke Scale score,22 and Geriatric
Depression Scale.19 Diagnostic interview (Diagnostic Interview and
Structured Hamilton), including the HRSD,18 Barthel Index,23 Stroke
Impact Scale (SIS),24 and percent perceived recovery (Overall Stroke
Impact),24 was assessed at entry but before randomization. Measures
of depressive symptoms, stroke impact, and perceived recovery were
repeated at 9 weeks (immediately postintervention), 21 weeks
postentry (roughly 6 months poststroke), and 12 months and 24
months poststroke. Functional and quality-of-life outcomes were
conceptualized according to the World Health Organization classification of persisting impairments, disabilities, and handicaps from a
variety of chronic illnesses.25 This multidimensional model of illness
considers interacting elements of body, person, and social function,
replacing the terms disability and handicap with more descriptive
terms: limitations in activities and restrictions in participation. We
measured limitation in physical ability by the Barthel Index, activities of daily living, strength, and mobility subscales of the SIS;
limitation in participation by the communication and work/recreation
subscales of the SIS; and overall stroke impact by percent perceived
recovery from the SIS.
Randomization and Masking
Randomization status was generated by a computerized adaptive
randomization procedure after the method of Pocock and Simon.26
This ensured that the 2 groups remained balanced with respect to
important predictors of outcomes: severity of stroke (National
Institutes of Health Stroke Scale), severity of depression at baseline
(HRSD), age, and gender. All outcome assessors were masked to the
participant’s randomization status at each data collection point. We
did not detect any breaches in masking.
Sample Size and Statistical Analysis
Over 1000 inpatients with stroke were tracked for potential screening
eligibility. The majority was not eligible (comatose, not ischemic
stroke, lived out of the region, no evidence of sadness, for example).
Two hundred eighty-nine agreed to be screened. One hundred
forty-eight of these were found eligible (Geriatric Depression Scale
ⱖ11 and confirmed stroke) and 101 enrolled (see the Figure for
details on exclusions). The sample of 101 is adequate to detect a 0.5
SD difference in average HRSD between the 2 groups. The primary
end point was HRSD at 12 months. The intent-to-treat analysis
controlled for baseline values of the primary outcome variable using
analysis of covariance for continuous variables (HRSD) and logistic
regression for binary variables (response or remission or not) at 12
months (primary end point) with alpha set at 0.05. Response was
defined as ⱖ50% reduction in HRSD, consistent with prior literature.
Remission has been defined variably as HRSD score of ⱕ9 (no
longer meeting depression criterion),13 ⱕ7 (absence of any depressive symptoms),27 or ⱕ3 (equivalent to healthy controls).28 We used
the more liberal HRSD score of ⱕ9 for comparison with previous
studies of PSD.13,14
Follow-up was achieved on all participants at 9 weeks, except the
one person who dropped out of the study after 1 week. Two others
in the intervention group dropped out between 9 weeks and 12
months. Two participants in the intervention group died of underlying medical illness before 12 months; none died in the control group.
Five dropped out or did not respond to 12-month follow-up in the
control group (Figure).
Results
The 2 groups were comparable at baseline in both demographic and stroke variables, except for the prevalence of left
hemisphere stroke and diabetes in the control group, as shown
in Tables 1 and 2. The participants were predominantly male
(59%), had moderate ischemic strokes, ranged in age from 25
to 88 years, and perceived themselves, on average, as approximately half recovered from their strokes (46.3% interven-
3076
Stroke
Table 3.
September 2009
Mean Change in HRSD Over Time
Follow-Up Time
N, N
Intervention
Control
Difference
CI
T
P Value
9 weeks
45, 53
⫺9.8 (4.9)
⫺3.6 (5.6)
⫺6.1
(⫺8.2, ⫺4.0)
⫺5.78
⬍0.001
21 weeks
46, 50
⫺8.3 (6.8)
⫺6.0 (6.5)
⫺2.2
(⫺4.8, 0.4)
⫺1.67
0.098
12 months
44, 48
ⴚ9.2 (5.7)
ⴚ6.2 (6.4)
ⴚ2.9
(ⴚ5.4, ⴚ0.4)
ⴚ2.32
0.023
24 months
34, 33
⫺11.3 (6.5)
⫺9.3 (4.7)
⫺2.2
(⫺4.9, 0.5)
⫺1.63
0.108
Primary end point is in bold.
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tion; 55.3% control). Roughly 70% of both groups had at least
one episode of depression before this stroke and 60% of each
group was taking antidepressants at entry. This increased to 77%
in each randomization group during the 8-week active treatment
period. Sertraline, citalopram, and paroxetine were the most
commonly prescribed selective serotonin reuptake inhibitor
drugs. Tricyclic antidepressants were not commonly prescribed
(11% of sample) with amitriptyline being the most common
tricyclic antidepressant, prescribed at bedtime.
status and scores for these variables with significantly better
scores for all indicators except the Barthel Index for those in
remission (Table 5). This finding is consistent with the
suggestion that poorer rehabilitation and recovery is moderated by depressive symptoms.
Discussion
This trial is the first to report long-term efficacy (1 and 2
years) of a psychosocial treatment in combination with
pharmacotherapy in PSD. It should be emphasized that the
recruitment was not aimed at those with first-ever depression
manifesting after stroke. Rather, it was a treatment for stroke
survivors who manifested a new or recurrent depression consistent with the Activate, Initiate, Monitor (AIM) trial described
subsequently.15 Few studies regarding the prevalence of PSD or
its treatment describe history of depression, although it is a
predictor of future depression.1
This study extends the findings of 2 additional trials in
stroke survivors that demonstrated short-term reduction in
depression with structured care management15 and with
motivational interviewing.16 The intervention in our trial is
related to but not the same as those in these recently
completed trials. LWWS was behavioral in focus, providing
participants with education and skills training to combat their
depression. The AIM trial had 3 components to care management: (1) an initial 20-minute structured psychoeducation
session with a nurse to activate the participant’s interest and
understanding of dealing with PSD and reduce stigma; (2) use
of a medication algorithm to initiate a recommendation for an
antidepressant to patient’s primary provide; and (3) a bimonthly telephone monitoring of depressive symptoms, medication side effects, and adherence. The timing and focus of
sessions with the nurse counselor were substantially shorter
than those in our study and more focused on optimizing
antidepressant therapy. Although the participants in the treatment arm reduced depression scores significantly over the
12-week follow-up compared with the usual care arm, the
drop in HRSD score and percent in remission were smaller
than in our more behaviorally oriented study. This latter
difference likely reflects the AIM trial’s use of a lower
Primary End Point
The primary hypothesis was supported. Mean decrease in
HRSD in the intervention group was significantly greater at 1
year when compared with the control group (⫺9.2⫾5.7
intervention versus ⫺6.2⫾6.4 control, P⫽0.023). As shown
in Table 3, when controlling for baseline HRDS scores,
change in HRDS was significantly greater in the intervention
group than in the control immediately posttreatment and at 1
year. The effect size is smaller after the first follow-up time
but remains stable thereafter, favoring the intervention.
Furthermore, as shown in Table 4, significantly more of the
intervention group was in remission (HRSD ⱕ9) immediately
after treatment and at 1 year. The effect was strongest at the first
follow-up and favored the intervention group at all time points.
By 24 months, the control group remission rate approached the
early response of the intervention group, whereas the intervention group continued to increase remission rate. There was no
significant interaction effect on treatment response between
treatment group and caregiver involvement at 1 year (data not
shown). Over three fourths of each randomization group reported taking an antidepressant (selective serotonin reuptake
inhibitor, nonselective serotonin reuptake inhibitor antidepressant, or tricyclic) during the 8-week intervention period. There
were no significant interactions of reported antidepressant use with
either immediate or 1-year remission rates (data not shown).
Secondary End Points
There was no significant main effect for randomization group
in examining indicators of limitation in ability (physical
function), participation, and percent recovery (overall impact)
at 12 months. However, there was an interaction of remission
Table 4.
Percent of Participants in Remission (HRSD <9) Over Time
N, N
Intervention
Control
OR
CI
␹2
P Value
9 weeks
45, 53
47%
19%
4.8
(1,8, 12.9)
10.54
0.001
21 weeks
46, 50
46%
22%
3.4
(1.3, 8.7)
6.98
0.008
12 months
44, 48
48%
27%
2.7
(1.1, 6.6)
4.66
0.031
24 months
34, 33
65%
46%
2.3
(0.8, 6.7)
2.29
0.130
Follow-Up Time
Primary end point is in bold.
Mitchell et al
Table 5.
Brief Psychosocial–Behavioral Intervention Reduces PSD
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Activity, Participation, and Stroke Impact by Remission Status at 12 Months
Remission Status at 12 Months
N
Mean (SD)
95% CI for Mean
Significance
No (HDRS ⬎9)
58
50.4 (24.7)
43.9, 56.9
F⫽14.65, P⬍0.001
Yes (HDRS ⱕ9)
34
71.1 (25.7)
62.2, 80.1
No (HDRS ⬎9)
58
62.5 (24.1)
56.2, 68.8
Yes (HDRS ⱕ9)
34
80.8 (23.8)
72.5, 89.1
No (HDRS ⬎9)
58
69.1 (23.6)
62.9, 75.3
Yes (HDRS ⱕ9)
34
82.8 (17.8)
76.6, 89.0
No (HDRS ⬎9)
58
86.4 (19.7)
81.2, 91.5
Yes (HDRS ⱕ9)
34
93.1 (15.7)
87.6, 98.6
No (HDRS ⬎9)
58
79.3 (19.4)
74.2, 84.4
Yes (HDRS ⱕ9)
34
90.7 (5.5)
85.2, 96.1
No (HDRS ⬎9)
58
53.0 (24.5)
46.5, 59.4
Yes (HDRS ⱕ9)
34
73.3 (22.4)
65.5, 81.2
No (HDRS ⬎9)
58
52.6 (23.6)
46.4, 58.8
Yes (HDRS ⱕ9)
34
74.5 (18.9)
67.9, 81.1
Limitation in ability
12-month strength (SIS)
12-month mobility (SIS)
F⫽12.47, P⫽0.001
12-month ADL (SIS)
F⫽8.57, P⫽0.004
12-month Barthel Index
F⫽2.88, P⫽0.09
Limitation in participation
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12-month communication
F⫽8.42, P⫽0.005
12-month work and recreation
F⫽15.78, P⬍0.001
Overall Stroke Impact
12-month percent recovered
F⫽21.174, P⬍0.001
ADL indicates activities of daily living. All scales are 0 –100 with higher scores being better.
remission score cutoff (HRSD score ⬍8). The AIM trial did
not report longer-term outcomes.15
Watkins and colleagues tested a motivational interviewing
approach in a randomized, controlled trial of 411 stroke
inpatients, not limited to those with depressed mood. The
goal was to assist patients still in the hospital to recognize and
achieving their own solutions to problems in adjustment to
physical and emotional aspects of stroke.16 Components of
this intervention are similar to the problem-solving portions
of our trial. Therapists supervised by clinical psychologists
provided 4 30- to 60-minute individual sessions of motivational interviewing over 4 weeks to patients randomized to
the treatment arm. A significantly larger proportion of those
who received motivational interviews had a “normal” mood
as measured by the General Hospital Questionnaire and did
not endorse feeling sad or blue (depression screen) post treatment compared with those with routine hospital care. Longerterm protection from depressive symptoms was not reported.
We postulated that the antidepressant treatment would
enable short-term mood elevation, whereas the behavioral
treatment would provide cognitive restructuring and specific
problem-solving skills for coping with ongoing stressors.
Future planned analyses will explore the degree to which
attainment of these skills is related to treatment response.
Although 77% of each group were prescribed and reported
taking antidepressants during the 8-week treatment period,
the doses and type of drug were not standardized. This is a
limitation of the study but represents the context of everyday
practice. Future planned subgroup analyses may help shed
light on the role of antidepressants in the rate of remission and
overall response to the behavioral treatment.
The findings of the LWWS study are similar to a British
series that does not include patients with PSD. They have
shown that a 6-session structured problem-solving psychological treatment can be delivered by various members of the
primary healthcare team for a variety of emotional disorders,
including major depression.29 –33 Recent comparison of antidepressant alone with combined problem-solving and antidepressant showed that both were equally effective in reducing
depressive symptoms (HRSD) over time with medication
alone having a smaller reduction than the psychosocial or
combined groups as well as a sustained effect to 1 year.31
Community health nurses and general practitioners were
equally effective, although patients were more satisfied with
the community nurse treatment.33
Psychosocial therapy combined with antidepressant has
been significantly more successful in preventing recurrent
depression in older adults than medication alone or psychosocial therapy and placebo.34 More relevant to PSD are the
trials of counseling and behavioral tailored problem-solving
interventions for depressed medically ill elderly delivered by
psychogeriatric teams and psychosocial nurse specialists in
the home compared with “standard” care. These have shown
a reduction in level of depression, improvement is self-
3078
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September 2009
perceived health, and sometimes improved functional status.35,36 Our trial, in combination with the AIM trial and the
motivational interviewing previously discussed, add to our
knowledge of the range of behavioral interventions effective in
the PSD population. Further planned analyses of the LWWS
trial will help suggest subgroups most responsive to treatment.
Summary
A brief psychosocial– behavioral intervention adjunctive to
antidepressant therapy is highly effective in reducing depression and achieving remission in the short term with the effect
sustained for up to 2 years. Participants in the usual care
control group also reduced their depression over the first year,
but more slowly and with a lesser degree of remission. Those
who achieved remission in either group had significantly
better perceived recovery, lower limitation in ability, and
greater social participation at all time points.
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Sources of Funding
This study was funded by the National Institute of Nursing
Research, National Institutes of Health grant R01NR007755, and
registered with the clinical trials identifier NCT00194454 www.
clinicaltrials.gov/ct/show/NCT00194454?order⫽1.
Disclosures
None.
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Brief Psychosocial−Behavioral Intervention With Antidepressant Reduces Poststroke
Depression Significantly More Than Usual Care With Antidepressant: Living Well With
Stroke: Randomized, Controlled Trial
Pamela H. Mitchell, Richard C. Veith, Kyra J. Becker, Ann Buzaitis, Kevin C. Cain, Michael
Fruin, David Tirschwell and Linda Teri
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Stroke. 2009;40:3073-3078; originally published online August 6, 2009;
doi: 10.1161/STROKEAHA.109.549808
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