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PST1 |
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EFFICACY OF BOTULINUM TOXIN
TYPE A (BONTA) IN THE TREATMENT OF ADULT FOCAL
SPASTICITY: A META-ANALYSIS OF RESPONSE RATE USING
INDIVIDUAL PATIENT DATA
Aldridge G1, Frost M2, LeReun C3, Lynch M4,
Davey P4, Napier-Flood F5, 1M-TAG Pty Ltd, A
Unit of IMS Health, Chatswood, Australia, 2M-TAG,
A Unit of IMS Health, Chatswood, Australia, 3M-TAG
Pty Ltd (A Unit of IMS Health), Chatswood, NSW,
Australia, 4M-TAG, A Unit of IMS Health, Chatswood,
NSW, Australia, 5Allergan Australia Pty Ltd,
Gordon, NSW, Australia
OBJECTIVE:
The efficacy of Botulinum toxin type A
(BoNTA) for the treatment of adult focal
spasticity was evaluated using a pooled analysis
of individual patient data from five randomised
controlled trials (RCTs). The objective of the
analysis was to determine an overall estimate of
patient response rate across spasticity of
different muscles. METHODS:
Individual patient
data from five double-blind RCTs of BoNTA versus
placebo for the treatment of focal spasticity were
included in the pooled analysis. The trials were
12-24 weeks in duration and enrolled patients with
post-stroke focal spasticity in upper or lower
limbs. The primary outcomes in the RCTs were
assessed using the Ashworth scale, a five-point
grading of muscle tonicity. As muscle hypertonia
interferes with movement, a reduction in muscle
tone is beneficial. For the pooled analysis, a
responder was defined as a patient who obtained a
decrease of at least two points in the Ashworth
scale measurement of any upper or lower limb
muscle, indicating a clinically significant
improvement. RESULTS:
The results of the responder
analysis indicated that 140/271 (51.7%) of
patients treated with BoNTA were responders
compared to 30/136 (22.1%) of patients treated
with placebo, a statistically superior result in
favour of BoNTA (risk difference 28%; 95%
confidence intervals 18-37%; p < 0.001). In
addition there were no significant differences
between treatment groups in the proportions of
patients that discontinued treatment or
experienced an adverse event, indicating
equivalent tolerability. CONLUSIONS:
The results
of this analysis indicate that significantly more
patients treated with BoNTA obtained a clinically
significant reduction of muscle tone, compared
with those receiving placebo. Improvement in
tonicity reduces muscle resistance and facilitates
the use of physical rehabilitation methods to
improve a patient’s ability to perform various
activities of daily living.
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PST2 |
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RESOURCES USE AND OUTCOMES OF
ACUTE CARE FOR FIRST-EVER ISCHEMIC STROKE IN
TAIWAN: SHORT VS. PROLONGED STAY PATIENTS
Tseng MC1, Chang KC2, 1National Sun Yat-Sen
University, Kaohsiung, Taiwan, 2Chang Gung
Memorial Hospital, Kaohsiung County, Taiwan
OBJECTIVE:
To analyze the distribution of
resources use and outcomes at discharge between
patients who had prolonged acute hospitalization
for first-ever ischemic stroke and those staying
for a shorter period of time. METHODS:
Data were
prospectively collected from 360 first-ever
ischemic stroke patients consecutively admitted to
a medical center within 48 hours after symptom
onset. Prolonged stay was defined as length of
stay (LOS) >7 days after admission in department
of neurology for acute care. Demographic and
clinical data at admission, resource use,
in-hospital mortality and outcomes at discharge
were collected. RESULTS:
Patients (58% male) had
mean age 64.9±12.7 (range, 18 to 93) years. Mean
National Institutes of Health Stroke Scale (NIHSS)
score at admission was 9.4 (median, 6); mean
modified Barthel Index (MBI; on a scale of 0 to
20) at admission was 10.7 (median, 12). Laboratory
work-up were ordered in all patients, 93% of
patients underwent emergent brain CT, 21% brain
MRI, 75% duplex ultrasound, and 76% initiated
rehabilitation in the acute care phase. The LOS
was >7 days in 169 (47%) patients. Overall,
patients with prolonged stay had more severe
stroke at admission by HINSS score (median, 10
versus 4). Mean (median) inpatient cost per
patient was US$748 ($610) for patients with
shorter stay, $2,984 ($1,316) for those with
prolonged stay. Mean (median) cost per day was
US$189 ($129) for patients with shorter stay, $139
($112) for those with prolonged stay. In-hospital
mortality was similar, 8% in group of prolonged
hospitalization and 7% in the other. Mean
improvement in NIHSS for those who survived acute
care and stayed longer were 1.3±6.8, MBI 2.4±5.0,
and similar for those stayed shorter, 1.3±3.2 and
2.5±4.4, respectively. CONLUSIONS:
The impact of
stroke severity need to be understood to manage
LOS. Early supported discharge planning would
probably reduce the prolonged acute
hospitalization.
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PST3 |
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HEALTH-RELATED QUALITY OF
LIFE OF STROKE SURVIVORS IN THE U.S.
Xie J1, Wu EQ2, Zheng ZJ3, Croft JB3,
Mensah GA3, Labarthe DR3, 1Center for Disease
Control and Prevention, Northrop Grumman, Atlanta,
GA, USA, 2Analysis Group, Boston, MA, USA, 3Center
for Disease Control and Prevention, Atlanta, GA,
USA OBJECTIVE:
To assess
health-related quality of life (HRQL) of stroke
survivors in the U.S. population. METHODS:
SF-12
and EQ-5D of the adults (age >=18) in the 2000 and
2002 Medical Expenditure Panel Survey (MEPS) were
examined in this study. Stroke was defined based
on the ICD-9 codes from 430 to 438. SF-12 physical
and mental scores and EQ-5D index scores of
patients with stroke were compared with those of
individuals without stroke. The differences in
HRQL scores between individuals with and without
stroke were reported using both absolute
difference and effect size (ES). Age, sex, race,
and geographic region were adjusted using a
stratification matching method. In addition,
subgroup analyses were conducted to compare HRQL
of stroke patients between younger (18-64 years)
and older (>=65 year) groups, males and females,
and whites and non-whites. All analyses were done
using individual weights to achieve nationally
representative estimates. RESULTS:
Among 39,735
adults included in the study, 515 were reported to
have stroke, corresponding to 1.3% of the U.S.
adult population. SF-12 physical score, mental
score and EQ-5D index score were 7.04, 4.33 and
0.15 point(s) lower, respectively, among stroke
patients, compared with non-stroke population. The
effect sizes were 0.57, 0.39 and 0.48,
respectively (all p-values <0.01). Subgroup
analyses revealed that stroke patients in the
younger group, female patients and nonwhite
patients scored 0.16, 0.08 and 0.10 lower in
EQ-5D, compared with their respective older age,
male, and white counterparts (all p-values <0.05).
In addition, stroke was further associated with
7.50 points lower SF-12 physical score in the
younger group (p<0.01). CONLUSIONS:
Stroke is
significantly associated with lower physical and
mental HRQL and overall health utility in the U.S.
The decrease in the quality of life seems to be
greater in the younger age, female, and nonwhite
groups.
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PST4 |
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HIGH INCIDENCE AND VARIATION
IN INTRACRANIAL ATHEROSCLEROTIC DISEASE (ICAD) IN
CHINA - EPIDEMIOLOGY AND TREATMENT OPTIONS
Ho G, Lacey M, Valentin M, Boston
Scientific Corporation, Natick, MA, USA
OBJECTIVE:
To study the incidence and geographical
variance of ischemic stroke resulting from ICAD,
an important risk factor for stroke, in the
various regions within China. To survey current
treatment options and describe new solutions.
METHODS:
A literature review was conducted and
incidence rates of stroke in the 29 provinces of
China were used to derive estimates for the
specific incidence of intracranial ischemic
stroke. Publications on the proportion of
different stroke subtypes in China were used to
determine the rates for ischemic stroke and
intracranial disease in China, and then estimate
how extensively the population is afflicted by
ICAD. RESULTS:
The geographic distribution of
stroke incidence and mortality in China varies by
region, ranging from 80.9/100,000 in Shanghai city
to 486.4/100,000 in Harbin city. In the urban
areas of Guangdong, Shanghai and Beijing, there
are an estimated 13,087, 12,855, and 3,534 persons
affected in the respective provinces. The nearby
provinces of Hebei and Hunan have respectively
43,792 and 49,362 affected. With improved
diagnostic capabilities, collection of this
specific data will give further clarification on
the variability in incidences of ICAD in China.
CONLUSIONS:
As incidence and mortality rates have
not been previously tracked for ICAD, values for
ICAD in regions of China are estimates based on
current literature. The results of the analysis
show a high incidence of ICAD. The burden of ICAD
is especially high in China compared to other
countries and suggests the need for a solution to
relieve the health care system and society of long
term care costs associated with ICAD sufferers. It
will be important to develop strategies to enhance
public awareness of risk factors and prevent the
disease. For those affected by ICAD seeking an
alternative to drug therapy and surgical bypass,
there is an unmet medical need for a minimally
invasive treatment.
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PST5 |
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MANDARIN VERSION OF STROKE
IMPACT SCALE: ADAPTATION AND VALIDATION
Chang KC1, Tseng MC2, Hung JW1, Lin TK1,
Tan TY1, Chen CH1, 1Chang Gung Memorial Hospital,
Kaohsiung County, Taiwan, 2National Sun Yat-Sen
University, Kaohsiung, Taiwan
OBJECTIVE:
To assess the properties of the
Mandarin version of the Stoke Impact Scale (SIS)
versions 3.0, developed by Pamela W. Duncan et al.
METHODS:
The SIS, a strokespecific outcome
measure, assesses 8 domains: strength (4 items),
memory (7 items), emotion (9 items), communication
(7 items), activities of daily living/instrumental
activities of daily living (ADL/IADL) (10 items),
mobility (9 items), hand function (5 items), and
participation (8 items). SIS was translated and
back-translated according to the standardized
guidelines for cross-cultural adaptation. Patients
consecutively admitted with ischemic stroke were
recruited, until 30 patients in each of three
groups of stroke severity were reached. Stroke
severity was evaluated with NIH stroke scale and
categorized as mild (0- 6), moderate (7-15), or
severe (16-38). Patients were assessed 3 times,
within 7 days of admission, 3 months and 6 months
afterwards. Ten randomly selected patients were
readministered 2 weeks after first administration
for test-retest study. RESULTS:
We studied 50
mild, 36 moderate, and 33 severe stroke patients.
Cronbach’s alpha was high for 6 domains (0.95 to
0.98), moderate for emotion (0.69) and
participation (0.77). Intraclass correlation
coefficients ranged from 0.63 to 0.89, except for
memory (0.13), hand function (0.47), and ADL/IADL
(0.53). Based on first assessment, memory and
communication may have potential for ceiling
effects in mild stroke group, strength and hand
function may have potential for floor effects in
moderate stroke group, and all domains may have
potential for floor/ceiling effects in severe
stroke group. The correlations between each of the
physical domains (strength, ADL/IADL, mobility,
hand function) and Barthel Index were good (0.72
to 0.92). Memory domain showed a high correlation
with MMSE (0.81). CONLUSIONS:
The Mandarin
version of the SIS is an acceptable
stroke-specific outcome measure in most domains.
Further studies in determining the content should
enhance confidence in its validity. |
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