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Development and evaluation of standardized stroke outcome measures in a population of stroke patients in rural China
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Development and evaluation of standardized stroke outcome measures in a population of stroke patients in rural China
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Content
DEVELOPMENT AND EVALUATION OF STANDARDIZED STROKE
OUTCOME MEASURES IN A POPULATION OF STROKE PATIENTS
IN RURAL CHINA
Copyright 2006
by
Chia-Chen Megan Chang
A Thesis Presented to the
FACULTY OF THE GRADUATE SCHOOL
UNIVERSITY OF SOUTHERN CALIFORNIA
In Partial Fulfillment of the
Requirements for the Degree
MASTER OF SCIENCE
(Applied Biostatistics and Epidemiology)
May 2006
Chia-Chen Megan Chang
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UMI Number: 1437818
Copyright 2006 by
Chang, Chia-Chen Megan
All rights reserved.
INFORMATION TO USERS
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DEDICATION
To my late grand mother, Pen Liao Pan, for her enduring love and lasting faith
me.
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ACKNOWLEDGEMENTS
I would like to express my greatest appreciation and gratitude to my thesis
committee chair and mentors, Dr. Stanley P. Azen, Dr. Katherine Sullivan, and Dr.
Sandra Howell, for their guidance, expert advice, and commitment of time. Also, I
would like to thank my supervisor, Dr. Steven Chen, for his help and support. A
special thank to my aunt, S. Telan Hu, for her editing, great support, and
encouragements over the years. Last, but not least, I would also like to thank my
parents for their endless love and untiring encouragement while I pursue my
educational goals.
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TABLE OF CONTENTS
DEDICATION.......................................................................................................................ii
ACKNOWLEDGEMENTS................................................................................................iii
LIST OF TABLES............................................................................................................... vi
ABSTRACT.........................................................................................................................vii
I. IN TRO D U CTIO N ........................................................................................................... 1
Stroke Incidence in China........................................................................................1
Rehabilitation Program of Traditional Chinese Medicine (TCM) in China.... 2
International Measures of Stroke Outcome...........................................................2
Purpose of this Study...............................................................................................6
II. M E T H O D ........................................................................................................................7
A. Reliability Assessments of Chinese Translation of Study Instruments....................7
A l. Study Instruments..............................................................................................7
A2. Translation and Back-Translation Process.................................................... 9
A3. Training Process of Clinical Evaluators in China.................................... 10
A4. Inter-Rater Evaluaion Procedure...................................................................10
A5. Statistical Analysis..........................................................................................10
B. Outcome Pilot Study..................................................................................................... 12
B l. Design............................................................................................................... 12
B2. Statistical Anslysis..........................................................................................12
III. RESU LTS.....................................................................................................................14
A. Inter-Rater Reliability Evaluation................................................................................14
A l. Descriptive of Study Cohort.......................................................................... 14
A2. Results of Intra-Class Correlation Coefficients (ICC) for Instruments... 14
A3.1. Results of Kappa for National Institue of Health Stroke Scale (NIHSS)
...................................................................................................................................15
A3.2. Results of Kappa for Mini-Mental State Examinations (MMSE) 15
A3.3. Results of Kappa for Barthel Index (B I).................................................. 16
A3.4. Results of Kappa for Modified Rankin Scale (M R S)............................ 16
B. Outcome Pilot Study..................................................................................................... 17
B l. Descriptive of Study Cohort.......................................................................... 17
B2. Results of Oucome Analyses.........................................................................20
B3. Bias Due to Missing Data..............................................................................20
iv
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IV. DISCUSSION........................................................................................................ 22
D 1. Summary of Inter-Rater Reliability Evaluation......................................... 22
D2. Summary of Outcome Pilot Study............................................................... 22
D3. Feasibility of Study in China......................................................................... 23
D4. Future W ork.....................................................................................................24
REFERENCES.....................................................................................................................25
APPENDICES.....................................................................................................................31
Appendix A. National Institute of Health Stroke Scale.................................... 31
Appendix B. Mini-Mental Status Examination.................................................. 39
Appendix C. Barthel Index................................................................................... 40
Appendix D. Modified Rankin Scale...................................................................42
v
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LIST OF TABLES
Tablel. Demographic Characteristics 13
Table2. Intra-Class Correlation Coefficients for Instruments 13
Table3.1 Inter-Rater Evaluation of the National Institute of Health Stroke Scale
(NIHSS) 14
Table3.2 Inter-Rater Evaluation of the Mini-Mental State Examination (MMSE) 15
Table3.3 Inter-Rater Evaluation of the Barthel Index (Bl) 15
Table4. Demographic Characteristics 16
Table5. Stroke Characteristics 17
Table6. Discharged Status 18
Table7. Risk Factors and Co-Morbidities 18
Table8. Total Score of Outcome Measurements 20
Table9. Difference between Completed and Partial-Completed Data 20
vi
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ABSTRACT
In China, stroke is a major public health problem associated with a high
incidence of mortality, disability and financial cost. The most commonly used
treatments for stroke patients in China are Traditional Chinese Medicine (TCM);
however, there is no consistent agreement in the literature regarding effectiveness
of TCM. The first aim of this study is to evaluate the inter-rater reliability for four
Chinese-translated international standardized outcome instruments used in stroke
research, including Barthel Index, Modified Rankin Scale, Mini-Mental Status
Examination and National Institute of Health Stroke Scale. The second aim is to
evaluate functional outcomes in a cohort of acute stroke patients treated with TCM
in China. Data has collected from four hospitals in Wuhan, China. The results of
the inter-rater reliability study showed moderate to excellent reliability between the
experienced raters from United States and the newly trained raters in China.
Analysis of the total scores of the four individual outcomes measures revealed that
there were significant functional improvements from admission to discharge from
the hospital after acute stroke (Pc.OOOl). Future research will focus on the
outcome of integrating TCM and Western rehabilitation techniques in the treatment
of acute stroke patients
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I. Introduction
Stroke Incidence in China
China has one of the largest stroke incidence and mortality rates in the
world based on the WHO MONICA project reports (Thorvaldsen et al., 1997; Jiang
et al., 2004). Stroke is the second leading cause of death among urban residents
and third leading cause among rural residents; therefore, it has become a major
public health problem in China (WHO, 1994; Cheng et al., 1995; Ma, Wang, Qu, &
Yang, 2004). A large-scale study of stroke in China from 1991 to 2000 showed
that the incidence of stroke increased every year, especially cerebral infarction
stroke (Zhang et al., 2003). According to Cheng et al.’s (1995) China seven cities
studies, the average annual age-adjusted incidence rate of stroke was 215.6 per
100,000.
Hypertension is one of the most common reasons for stroke in China. Over
70% of the geographic variability in stroke incidence is due to a high prevalence of
hypertension, and that is attributed to 50% of the annual mortality of stroke (He,
Klag, Wu, & Whelton, 1995; Fang et al., 2001). An ecological study conducted by
China’s National Hypertension Survey and National Stroke Study showed that
there was a larger prevalence of hypertension and a larger stroke incidence and
mortality in the north of China compared to the south of China (He, Klag, Wu, &
Whelton, 1995).
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Rehabilitation Program of Traditional Chinese Medicine (TCM) in China
In China, bed rest, acupuncture, moxibustion, massage and intravenous
herbal therapy is the Traditional Chinese Medicine (TCM) approach to treat post
stroke patients (Chang, 1994; Chang, 1996; Chang, 1996; Zuo, 2003). However,
most of the published research has focused only on effectiveness o f acupuncture
treatment after stroke. Moreover, there are no consistent agreements regarding
effectiveness of TCM documents in the literature. For instance, Park et al. (2001),
Sze et al. (2002), and Zhang, Liu, Asplund, & Li (2005) have done systematic
reviews of stroke studies and found that there was no definitive evidence to show
the benefit of acupuncture in acute and chronic stages of stroke. On the other hand,
more recently published articles by Alexander et al. (2004), and Park et al. (2005)
have shown that there was effectiveness in motor recovery and leg function in more
severely affected patients, respectively. In contrast, stroke rehabilitation studies
conducted in the western countries have shown significant efficacy of receiving
rehabilitation (Steultjens et al., 2003; Kwakkel et al., 2004; Legg, Langhome, &
Outpatient Services Trialists, 2004). Western rehabilitation typically includes
physical therapy and occupational therapy. Thus, it is possible that integrating
traditional Chinese medicine with Western methods may benefit stroke patients in
China.
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International Measures o f Stroke Outcome
The International Classification of Impairments, Disabilities, and Handicaps
(ICIDH) was created by the World Health Organization (WHO) and conceived as
“a response to the problem of evaluating the effectiveness of a health care process”
(Gray & Hendershot, 2000, p. slO). As such, the ICIDH model was proposed as
follows:
Disease/disorder Impairment Disability Handicap
(body) (person) (person-environment)
Impairment defines abnormalities o f body structure and appearance along with
organ or system functions, resulting from any causes that represent disturbance at
the organ level. Disability is concerned with the consequences o f impairment, that
impacts functional performance and activity. As such, disability represents
disturbances at the level of the person. Handicap reflects the disadvantages
experienced by the individual due to impairment and disabilities; therefore,
handicap represents interaction with and adaptation to the individual’s surroundings
(Gray & Hendershot, 2000).
Due to the limitation in perspectives of the ICIDH model, a revision, the
ICIDH-2 was then formed to reflect both positive and negative aspects of
disablement dimensions. In order to set up a platform to describe “... functional
status associated with health conditions and to improve communication among
health care workers, other sectors, and people with disabilities” (Gray &
Hendershot, 2000, p. 12), the ICIDH-2 was depicted as follows:
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Body function & structure Activities ** Participation
/ [ \ A \ A \
(Disease or Disorder)
Body function or structure (impairment in the ICIDH model) describes significant
deviation or loss, depicted as impairment (Gray & Hendershot, 2000). Activities
(functional limitation in the ICIDH model) are described as an individual’s
observable and reportable performance of the capable actions in the context of the
individual’s culture rather than focusing on disability as the individual’s negative
experience (Gray & Hendershot, 2000). Participation (disability in the ICIDH
model) is defined as “an individual’s involvement in life situations in relation to
health conditions, body functions and structures, activities and contextual factors”
(Gray & Hendershot, 2000, p. s i 3; WHO, 1999).
Drawing on the concept of the ICIDH-2 model, four internationally
recognized functional-based instruments were selected for this study to collect
patient-specific information on pathological, neurological, functional and cognitive
status. The instruments included the National Institute of Health Stroke Scale
(NIHSS), the Mini Mental State Examination (MMSE), the Barthel Index (Bl), and
the Modified Rankin Scale (MRS). The MMSE and the NIHSS measures body
function and impairment; the Bl measures one’s activities and function, whereas
the MRS measures participation and disability.
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- Body Function & Structure (Impairment) Measure
The NIHSS is a stroke-related neurological measurement scale, specifically
created for use in clinical trials of acute stroke, which has demonstrated intra-rater
and inter-rater reliability; it also has predictive validity for stroke outcome (Brott et
al., 1989; Kasner et al., 1999; Lyden et al., 1994; Muir et al., 1996). Also, Dewey
et al. (1999) and Goldstein & Samsa (1997) have shown that newly stroke-trained
research evaluators can administer the NIHSS with reliability similar to
experienced neurologists.
The MMSE, created by Folstein, Folstein, & McHugh (1975), has been
widely used for assessing cognitive mental status and to screen for cognitive
impairment (Folsteins, Folstein, & McHugh, & Fanjian, 2001; Lopez, Charter,
Mostafavi, & Nibut, 2005). It has high sensitivity and specificity as well as
demonstrated validity and reliability in various populations (Folstein, Folstein, &
McHugh, 1975; Anthoy et al., 1982; Tombaugh & McIntyre, 1992).
-Activities (Functional Limitation) Measure
Mohoney and Barthel developed the Bl in 1965; it was later modified by
Granger and coworkers (Mohoney & Barthel, 1965; Granger, Albrecht, &
Hamilton, 1979; Suiter, Steen, & Keyser, 1999). The modified Bl has been
validated and used globally (Sze, Wong, Lum, & Woo, 2000; Berge, Fjasrtoft,
Indredavik, & Sandset, 2001; Kwon, Hartzema, Duncan, & Lai, 2004). The main
purpose of Bl is to understand the degree of dependence and how much help a
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patient may require after a stroke (Suiter, Steen, & Keyser, 1999; D ’Olhaberriague,
Litvan, Mitsias, & Mansbach, 1996).
-Participation (Disability) Measure
The MRS is a global measure of clinically discrete patient disability
categories; therefore, cognitive and physical sequelae of the neurological deficits
are included in this overall rating scale (Suiter, Steen, & Keyser, 1999; Kwon,
Hartzema, Duncan, & Lai, 2004). By using a structured interview, the reliability of
MRS has been found to be satisfactory as well as across multiple raters (van
Swieten et al., 1988; Wilson et al., 2002).
Purpose of this Study
This purpose of this study is to determine the feasibility of conducting
stroke outcome research in central China. In order to determine feasibility, two
specific objectives were identified as follows: 1) to determine the inter-rater
reliability of newly-trained Chinese evaluators in assessing stroke patients using
Chinese-translations of the four instruments (part A), and 2) to examine the change
in stroke outcomes between admission and discharge after acute stroke in Wuhan,
China, using the Chinese-translated standardized instruments (part B). To this end,
two study cohorts were recruited and evaluated. For part A, 21 patients were
recruited for the inter-rater reliability test (Cohort 1) and for part B, 113 patients
were recruited for outcome pilot study (Cohort 2).
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II. Methods
A. Reliability Assessment of Chinese Translation of Study Instruments
Overview
Four instruments were selected, namely, National Institute o f Health Stroke
Scale (NIHSS), Mini Mental State Examination (MMSE), Barthel Index (Bl), and
Modified Rankin Scale (MRS). All four instruments were translated into Chinese,
and then back-translated into English to verify accurate translation. Data were
obtained for the instruments and evaluated on a cohort of 21 patients (Cohort 1) at
the time of admission. Measures of inter-rater reliability were then calculated.
Details are as follows.
A l. Study Instruments
National Institute o f Health Stroke Scale (NIHSS)
The NIHSS is a 15-item neurological examination stroke scale used to
examine the level of consciousness, language function, neglect, visual-field loss,
extraocular movement, facial symmetry, motor strength, sensation and coordination
(Brott et al., 1989; Lynden et al., 1994; Kasner et al., 1999). The range of the total
score is from 0 (normal) to 40 (most severe). (See Appendix A)
M ini M ental State Examination (MMSE)
The MMSE assesses the cognitive mental status which consists of 30 items
grouped into 11 categories, including orientation, attention, immediate and short-
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term recall, language, and the ability to follow simple verbal and written commands
(Folsteins, Folstein, McFIugh, & Fanjiang, 2001; Lopez, Charter, Mostafavi, &
Nibut, 2005). The maximum total score is 30 (high cognition) and the minimum is
zero (coma state). Normative data exist for the MMSE in order to evaluate
patients’ cognitive status (Crum, Anthony, Bassett, & Folstein, 1993). (See
Appendix B)
Barthel Index (Bl)
The Barthel Index, an ordinal scale, measures patients’ performance in daily
activities including self-care (feeding, grooming, bathing, dressing, bowel and
bladder, and toilet use) and mobility (ambulation, transfers, and stair climbing)
(Mohoney & Bathel, 1965; Suiter, Steen, & Keyser, 1999). There are a total of ten
questions: personal toilet and bathing are estimated with a 2-score scale (0 and 5
points); feeding, getting onto and off the toilet, ascending and descending stairs,
dressing, controlling bowels, and controlling bladder are estimated with a 3-score
scale (0, 5, and 10 points); moving from wheelchair to bed and returning, and
walking on a level surface are estimated with a 4-score scale (0, 5, 10, 15 points)
(Kwon, et al., 2004). The highest score is 100, implying that the patient is fully
independent in activities of daily living (ADL); the lowest score is 0 implying that
the patient is totally dependent in ADL, namely, in a bedridden state (Kwon,
Flartzema, Duncan, & Lai, 2004). (See Appendix C)
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M odified Rankin Scale (MRS)
The Modified Rankin Scale consists of one question measuring clinically
distinct functional states of the patient, that of defining “six levels of disability and
one for death" (Kwon, Hartzema, Duncan, & Lai, 2004). The scale is described as
follows (Dromerick, Edwards, & Diringer, 2003; Kwon, Hartzema, Duncan, & Lai,
2004). (See Appendix D)
These four stroke outcome measurements were tested both when the patient
was admitted to and discharged from the hospital. Completing these four would
take up less than 30 minutes.
A2. Translation and Back-Translation Process
First, a native Chinese speaker translated all instruments from English into
Chinese. Then, two people (one native Chinese speaker and one native English
speaker) interactively back-translated the Chinese translation to English to ensure
that the Chinese translation had captured all the measurement contents of the
English version. The native Chinese speaker had never read an English version
prior to the back-translation process. If the native English speaker identified a
misclassified and mistranslated word, then the aforementioned process of English
to Chinese translation would be repeated. Few questionable translations were
found during the back-translation process.
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A3. Training process of clinical evaluator
Several experienced American researchers paid two visits to China in order
to train the doctors and nurses to perform the stroke outcome instruments correctly.
The training on the first visit included: 1) lecture style workshop, 2) lab practice,
and 3) practice on patients observed by the American researchers. A lecture style
workshop covered stroke related materials, such as the disablement model, the
aforementioned four selected stroke outcome measurements, as well as review of
the NIH videotape. On the second visit, inter-rater reliability evaluation was then
carried out.
A4. Inter-Rater Evaluation Procedure
There were 21 stroke patients (a sample of convenience) recruited from four
hospitals in Wuhan, central China. In order to evaluate the patients, two raters for
each patient were randomly selected. This was accomplished by selecting one
experienced American researcher (from two experienced researchers) and one
newly trained doctor or nurse (from four possible trained candidates). Evaluations
using the instruments were made at time of admission.
The evaluation followed the procedure described by Kloos et al. (2004) as
follows: the newly trained doctor or nurse was designated the administering rater
(AR). The AR scored each patient’s performance at the time of admission. The
American researchers were designated as observing raters (OR). The OR watched
the assessment at a distance of less than 8 feet from the subject and scored each
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patient’s performance as the AR administered the test. During the evaluation, the
raters did not speak to each other. This design for evaluation was used because
acute stroke patients could not tolerate repetitive performance tests on a single day
due to excessive fatigue and evaluating patients on different days was not a viable
option due to rapid changes that can occur in the acute stroke recovery phase. In
addition, this method was more practical given the logistics (i.e., transportation,
translator’s availability) of the American researchers as visiting scientists to China.
A5. Statistical Analysis
The inter-rater reliability for both the total score and individual items were
evaluated for each instrument: NIHSS, MMSE Bl and MRS. The intra-class
correlation coefficient (ICC) was used for total scores o f NIHSS, MMSE and Bl
(Kasner et al., 1999). A ICC=1 refers to perfect reliability and >0.8 is considered as
excellent reliability (Fleiss, 1981; Kasner et al., 1999). The kappa was used to test
inter-rater reliability for each item. The strength of agreement associated with
kappa statistics was suggested by Landis & Koch (1977) as follows: <0.00=Poor;
0.00-0.20=Slight; 0.21-0.40 =Fair; 0.41-0.60=Moderate; 0.61-0.80=Substantial;
0.81-1.00=Almost Perfect. SAS version 9.0 and SPSS 11.0 were performed for
statistical analysis.
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B. Outcome Pilot Study
Overview
The Chinese translation instruments were used to evaluate stroke status in a
cohort of 113 patients (Cohort 2) at the time of admission and at discharge. Details
are as follows:
B l. Design
Eligible participants, who consented to the study, received stroke
assessments at the time of admission and discharge. To keep confidentiality, each
participant was given a five-digit ID. Their consent forms and tests were stored in
a separate cabinet with locks. In addition, questions on personal information and
stroke history and relative risk factors were assessed. The version of Chinese
translation instruments— National Institute of Health Status Scale, Mini-Mental
Status Examination, Barthel Index, and Modified Rankin Scale— were used.
B2. Statistical Analysis
Data were all entered in Microsoft Access in four databases: demographic
data, test at admission, test at discharge and discharge status. Differences between
admission and discharge of total scores of these four outcome measures were
analyzed by using a student t-test on MRS and total scores of the NIHSS, MMSE,
and BL If a data in the instrument was completely missing either in admission or
discharge evaluation, then that data was deleted from the analysis. Missing data
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analyses was performed at both admission and discharge for the four instruments to
assess if there is bias due to missing data. All analyses were conducted at the
significance level of 0.05; SAS version 9.0 was used for statistical analysis.
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III. Results
A. Inter-Rater Reliability Evaluation
A l. Description of Study Cohort
Twenty-one patients, 8 females and 13 males, were recruited for the inter
rater reliability evaluation (Table 1). The average age was 60.3 years. All of them
were of Han ethnicity, the major ethnic group in the Peoples Republic o f China.
Most of them had strokes on the left hemisphere (43%).
Table 1: Demographic Characteristics at time of Admission
Characteristic #(%) or MeaniSD
Gender Female 8 (38.1%)
Male 13 (61.9%)
Age (year) All 60.3 ± 11.7
Female 57.1 ± 11.2
Male 62.4 ± 12.9
Ethnicity Han 21(100%)
Side of stroke Right 7 (33%)
Left 9 (43%)
Bilateral 2 (10%)
Unkown 3 (14%)
A2. Results of Intra-Class Correlation Coefficients (ICCs) for instruments
The range of intra-class correlation coefficients (ICCs) for each instrument
was between 0.8 and 0.98 (Table 2). These three measurements show the excellent
reliability between the raters.
Table 2: ICC for Each Instrument
Instrument ICC (95% Cl)
MMSE 0.93(0.82-0.97)
NIH 0.98(0.96-0.99)
Bl 0.80(0.58-0.91)
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A.3.1. Results of Kappa for the NIHSS
Substantial to almost perfect agreement (kappa range 0.61-1.00) was found
in all individual items of the National Institutes of Health Stroke Scale (NIHSS)
between the raters, except the level of consciousness (0.26, fair agreement); facial
palsy (0.31, fair agreement); and extinction (0.42, moderate agreement) (Table 3.1).
Table 3.1: Inter-Rater Evaluation of the NIHSS
Scales Items Kappa
NIH1 Level of Consciousness (LOC) 0.26
NIH2 LOC Questions (Date, Age) 0.82
NIH3 LOC Follow Commands 1.00
NIH4 Best Gaze 0.65
NIH5 Visual 0.65
NIH6 Facial Palsy 0.31
NIH7 Left Motor Arm 0.87
NIH8 Right Motor Arm 0.90
NIH9 Left Motor Leg 0.52
NIH10 Right Motor Leg 0.60
NIH11 Limb Ataxia 0.60
NIH12 Sensory 0.83
NIH13 Best Language 0.76
NIH14 Dysarthria 0.59
NIH15 Extinction 0.42
A3.2. Results of Kappa for the MMSE
The kappa on Mini-mental State Exam (MMSE) indicated that most items
were in substantial to almost perfect agreement (0.61-1.00) with the exceptions of
date orientation (0.45, moderate agreement); attention and calculation (0.56,
moderate agreement); ability to follow 3-step commands (0.12, fair agreement);and
language-MMIO (0.56, moderate agreement) (Table 3.2).
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Table 3.2: Inter-Rater Evaluation of the MMSE
Scales Item Kappa
MM1 Orientation-Date 0.45
MM2 Orientation-Location 0.71
MM3 Registration 0.62
MM4 Attention and Calculation 0.56
MM5 Recall 0.92
MM6 Language- recognize and say watch and pencil 1.00
MM7 Language- repeat “No if, ands, or buts” 0.82
MM8 Language- ability to follow 3-step commands 0.12
MM9 Language- close eyes 0.82
MM10 Language- sentence 0.56
MM11 Copy 0.78
A3.3. Results of Kappa for the Bl
For the Barthel Index (Bl), only “feeding” was in fair agreement (k=0.33);
for the rest of the items, there was moderate to substantial agreement (kappa range
0.41-0.8) (Table 3.3).
Table 3.3: Inter-Rater Evaluation of the Bl
Scales Items Kappa
BI1 Feeding 0.33
BI2 Transferring (bed to chair) 0.62
BI3 Wash face, Brush teeth and Brash hair 0.48
BI4 Toileting 0.55
BI5 Bathing 0.55
BI67 W alking AVhee lchair 0.56
BI8 Walk up and down stairs 0.56
BI9 Dress/Undress 0.71
BI10 Bowel Control 0.78
B ill Bladder Control 0.62
A.3.4. Results of Kappa for the MRS
Kappa for MRS was 0.54.
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B. Outcome Pilot Study
B l. Description of Study Cohort
Table 4 demonstrates the demographic data of the participants. There was a
total of 131 participants in this study with 33.6% females and 66.4% males. The
average age was 60.7 years, whereas, 61.2 years for males and 60.6 years for
females. The age range was between 34.5 and 86.2. All of them were of Han
ethnicity.
Table 4: Demographic Characteristics
Characteristic # (% total)
Admissions by 1 Di-Yi
Hospital 29 (22.1%)
2 Cai-Dia
51 (38.9%)
3 Han-Na
34 (26%)
4 Xi-Hu
17 (13%)
Age (year)
60.6 ± 13.6 (Female, N=44)
61.2 ± 11.1 (Male, N=87)
Gender Female
61.0 ± 12.0 (All, N=131)
44 (33.6%)
Male
87 (66.4%)
Ethnicity
Han
131 (100%)
As for stroke characteristics (Table 5), most of them had ischemic strokes
(58%) comparing to hemorrhagic strokes (37.4%). Of them, 72% of them did not
have a stroke history. The proportions on affected sides were similar (right: 34%,
left: 38%). The main method of diagnosis was based mostly on Computed
Tomography (CT) (86.3%). On the average, duration between symptoms' onset to
seeing a doctor was 4.5 days among the four hospitals; whereas Xi-Hu hospital had
the longest duration (9.8 ± 36.94) and Cai-Dia hospital had the shortest (1.5 ± 2.8).
Table 5: Stroke Characteristics
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Stroke Type
Ischemic
77 (58.8%)
Hemorrhagic
49 (37.4%)
Uncertain
3 (2.3%)
Ischemic &
Hemorrhagic 2(1.5% )
Stroke Location
R hemisphere
45 (34.4%)
L hemisphere
50 (38.2%)
Cerebella
1 (0.8%)
Bilateral
18 (13.7%)
Brainstem
7 (5.3%)
R hemisphere +
Brainstem 1 (0.8%)
Cerebellar +Bilateral +
Brainstem 1 (0.8%)
Unknown (Missing) 8(6.1%)
Method of diagnosis
CT
113 (86.3%)
MRI
5 (3.8%)
Clinical criteria
8(6.1%)
CT + Clinical criteria
2(1.5% )
MRI + Clinical criteria
1 (0.8%)
Missing
2(1.5% )
Previous stroke
No
94 (71.8%)
Yes
36 (27.5%)
Missing
1(0.8%)
Stroke Events
Symptom onset to All four hospitals:4.5± 16.1 (N=130)
admission (day)
By Hospitals:
1) Di-Yi: 8.4 ± 17.8 (N=29)
2) Cai-Dia: 1.5 ± 2.8 (N=50)- (Missing=l)
3) Han-Na: 3.1 ± 5.5 (N=34)
4) Xi-Hu: 9.8 ± 37 (N=17)
Regarding the discharge status (Table 6), the length of hospital stay was
17.3 days. After they were discharged from the hospital, most of them (94%) went
home with the family and only 21.4% would continue to receive rehabilitation at
the hospital.
18
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Table 6: Discharge Status
Discharge status
Discharge arrangement
Received rehab services after DC
Length of hospital stay
Home alone
Home with family
Home with assistant
Transferred to rehab hospital
Transferred to other location
Transferred to other location
Death
Missing
At Hospital
At Local Clinics
No
Missing
17.3 ± 14.4 (n=130)
Di-Yi: 18 ± 14.9 (N=29)
Cai-Dia: 21.4 ± 11.9 (N=51)
Han-Na: 8.9 ± 5.4 (N=34)
Xi-Hu: 21.1 ± 24.8 (N=16)
1 (0.76%)
123 (93.89%)
0 (0%)
0 (0%)
1 (0.76%)
3 (2.29%)
1 (0.76%)
2(1.53% )
28 (21.37%)
45 (34.35%)
54 (41.22%)
4(3.05%)_________________
The risk factors and co-morbidities of a stroke are listed in Table 7. 16.8%
were current smokers, whereas 44.2% were former smokers. Up to 80 % to 90%
did not have prior TIA, diabetes or alcohol abuse history or atrial fibrillation.
Table 7: Risk Factors and Co-morbidities
Characteristic # (% total)
Prior TIA No
109 (83.2%)
Yes
18 (13.7%)
Missing
4(3.1% )
Current smoker
No
107 (81.7%)
Yes
22 (16.8%)
Missing
2(1.5% )
Former smoker
No
68 (51.9%)
Yes
58 (44.3%)
Missing
5 (3.8%)
Diabetes
No
118 (90.1%)
Yes
12 (9.2%)
Missing
1 (0.8%)
Cholesterol > 240 mg/dl (5.20 mmoPL)
No
81 (61.8%)
Yes
17 (12.9%)
Missing
33 (25.2%)
Average value 4.8 ± 0.9 (N=17)
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Alcohol abuse
No
107 (81.7%)
Yes
19 (14.5%)
Missing
5 (3.8%)
Systolic BP at 166.78 ±32.5 (N=129)
Blood pressure admission
Diastolic BP at
admission
98.6 ± 18.6 (N=129)
Carotid stenosis
No
52 (39.7%)
Yes
3 (2.2%)
Missing
76 (58.0%)
Atrial fibrillation
No
123 (93.9%)
Yes
3 (2.3%)
Missing
5 (3.8%)
B2.Results of Outcome Analyses
Data were analyzed based on the both admission and discharged completed
dataset. An analysis of total scores of these four outcome measures revealed that
there were significant functional improvements from admission to discharge (Table
8).
Table 8: Total score of outcome measurements
N
Admission DC Diff P-value
NIHSS
106
8.1 ±8.5 4.4 ± 7.6 3.7 ±4.9 <.0001
MMSE
101
20.3 ±8.1 24.6 ±6.3 4.3 ±5.5 <.0001
BI
55
62.3 ± 3 6 80.5±30 18.2 ± 2 9 <.0001
MRS
125
3.3 ± 1.4 2.4 ± 1.5 -0.8 ±1.1 <.0001
B3. Bias Due to Missing Data
When the raw datasets were examined, it was evident that a proportion was
not fully completed. O f the 131 patients, there was substantial missing data.
Analyses were conducted on differences between completed and partially
20
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completed data on both admitted and discharged total scores among the four
instruments. Reasons for missing data included evaluators did not complete the
evaluations correctly when the patient was in a coma or died or if a relative of the
patient declined. In addition, there was a high rate of incomplete BI forms since
the forms were truncated during copying. This resulted in a significant difference
at admission for the partial-completed and completed BI forms (p=0.0017) (Table
9).
Table 9: Difference between completed and partial-completed data
N Partial-Completed N Completed P-value
NIHSS Admission 16 10.6 ± 8 .6 115 8.3 ±8.7 0.33
Discharge 14 7.9 ±8.3 115 4.8 ±8.2 0.18
MMSE Admission 7 20.6 ± 4.9 104 20.5 ±8.1 0.97
Discharge 5 24.2 ±4.1 111 24.6 ± 6.3 0.89
BI Admission 67 41.5 ± 31.5 62 60.6 ± 36.1 0.0017*
Discharge 64 70.8 ±30.1 63 78.3 ±31.6 0.17
* P<0.05, statistically significantly different from complete and non-complete total scores
21
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IV. Discussion
D l. Summary and Limitations of the Inter-Rater Reliability Evaluation
For the inter-rater reliability study (part A), the intra-class correlation
coefficient (ICC) shows excellent reliability between raters for the NIHSS, MMSE,
and BI. The Kappa analysis of each item for these instruments and the MRS had
moderate to almost perfect agreement between the experienced and newly trained
raters. However, a few specific items had only slight to fair agreements between
the raters. These items included the feeding test in the BI, language test of ability
to follow 3-step commands in MMSE, and level of consciousness and facial palsy
tests in NIHSS. Therefore, we suggested that the instructions for these tests needed
to be re-addressed for the newly trained doctors or nurses. Besides, because of the
budget limitation, there was little manpower to devote to the translation and
training processes. The inter-rater reliability study demonstrates the feasibility of
training inexperienced Chinese doctors and nursed on internationally recognized
stroke outcome measures. This level of expertise will allow for future studies that
includes larger sample sizes
D2. Summary and Limitations of the Outcome Pilot Study
The overall purpose of this study was to determine if the translated version
of internationally recognized stroke outcome instruments could be used to measure
improvements between admission and discharge from a hospital in rural China
(part B). This outcome pilot study demonstrated that these four instruments could
22
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be used to show highly significant improvements between admission and discharge
for acute stroke patients in China.
The limitations of this study were related to high amounts of missing data.
Even though the missing data analyses indicated that that there was a significant
difference between complete and non-complete data in admission evaluation on BI,
those missing values were mostly due to forms cut off on copying because the size
paper used in China is different from letter size in the USA. Other than that, lack
of ability to cooperate (non-responsive of patients), relatives declining to receive
the evaluation in the middle of the test, and evaluator did not complete forms
completely were another reasons to result in missing data. Some of these latter
problems have been addressed with improvements in the training process.
D3. Feasibility of Study in China
This is the first step to show that the training for evaluators in China was
feasible and successful. This study shows that it is possible to implement
infrastructure research through collaboration with foreign researchers in a foreign
country. The successful translation of international standardized stroke
assessments offers more possibilities for researchers to study in China. Also,
results indicate that the training for evaluators and the translated international
stroke outcome assessments into Chinese were successful and the results of
outcome measurements were all significant. Therefore, based upon this, doors are
23
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opened for researchers and there are more possibilities for researchers to conduct
further studies in China.
D4. Future Work
The results of this successful pilot study encourage future study in
comparing traditional Chinese medicine (TCM) and the Western rehabilitation
treatments as well as in understanding the possible integration of the two. Further
work will be needed to obtain and describe the prescriptions for Chinese herbal
medicine and other treatments that patients receive.
24
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Appendix A.
NIH STROKE SCALE T h e NINDS t-PA S tro k e Trial N o . _________-__________
FORM 5 P t. D a te of B irth ________/_
1 of 4 H o s p ita l________________________________(__
D a te of E x a m ________/_.
Interval: 1 [] Baseline 2[ ] 2 hours post treatm ent 3[ ] 24 hours post onset of sym ptom s ±20 minutes 4[ ] 7-10 days
5[ ] 3 m onths 6[ ] O th e r______________________________________ (________)
T im e :_______ :_______ 1[]a m 2 []p m
Adm inister stroke scale items in the order listed. Record perform ance in each category after each subscale exam. Do not go
back and change scores. Follow directions provided for each exam technique. Scores should reflect what the patient does, not
what the clinician thinks the patient can do. The clinician should record answers while adm inistering the exam and work quickly.
Except where indicated, the patient should not be coached (i.e., repeated requests to patient to m ake a special effort).
IF ANY ITEM IS LEFT UNTESTED, A DETAILED EXPLANATION MUST BE CLEARLY WRITTEN ON THE FORM. ALL
UNTESTED ITEMS WILL BE REVIEWED BY THE MEDICAL MONITOR, AND DISCUSSED WITH THE EXAMINER BY
TELEPHONE.
Instructions S cale Definition S core
1a. L evel o f C o n sc io u s n e s s : T h e investigator m u st c h o o se a
re sp o n se, e v e n if a full evaluation is p rev en ted by su c h o b sta c le s a s an
en d o tra ch e al tu b e, lan g u a g e barrier, o rotracheal tra u m a /b a n d a g e s. A
3 is sco red only if th e p atien t m a k e s no m o v em en t (o th er th an reflexive
posturing) in re sp o n se to noxious stim ulation.
0 = Alert; keenly re sp o n siv e .
1 = Not alert, but a ro u sa b le by m inor stim ulation to obey,
answ er, or re sp o n d .
2 = Not alert, req u ires re p e a te d stim ulation to a tten d , o r is
obtu n d ed and req u ires stro n g or painful stim ulation to
m ak e m o v em en ts (not stere o ty p ed ).
3 = R esp o n d s only with reflex m otor or au to n o m ic effects or
totally un re sp o n siv e , flaccid, areflexic.
1b. LO C Q u estio n s: T h e p atien t is a sk e d th e m onth an d h is/h er ag e .
T he an sw er m u st b e correct - th e re is no partial credit for being close.
A phasic a n d stu p o ro u s patien ts w ho do not c o m p re h en d th e questions
will sco re 2. P atien ts unable to s p e a k b e c a u s e of en d o tra ch e al
intubation, orotracheal trau m a, s e v e re d y sarthria from any c a u se ,
lan g u a g e barrier or an y other problem not s e c o n d a ry to a p h a sia are
given a 1. It is im portant th at only th e initial a n sw e r b e g ra d ed an d that
th e exam iner not "help" th e patient with verbal o r non-verbal cu e s.
0 = A nsw ers both q u estio n s correctly.
1 = A nsw ers o n e q u estio n correctly.
2 = A nsw ers n either q u estio n correctly.
1c. LO C C o m m a n d s : T he p atien t is a sk e d to o p en an d c lo se th e
e y e s an d th en to grip an d re le a s e th e n on-paretic han d . Substitute
a n o th e r o n e s te p co m m an d if th e h a n d s ca n n o t b e u se d . C redit is
given if an unequivocal attem p t is m a d e but not com pleted d u e to
w e a k n e ss. If th e patient d o e s n o t resp o n d to co m m an d , th e task
should b e d em o n stra te d to th em (pantom im e) a n d sc o re th e result (i.e.,
follows n one, o n e or two co m m an d s). P atien ts with traum a,
am putation, or o th er physical im pedim ents should b e given suitable
o n e-ste p c o m m an d s. Only th e first attem p t is sco red .
0 = Perform s both ta s k s correctly
1 = Perform s o n e ta sk correctly
2 = Perform s neither ta sk correctly
2. B est G aze: Only horizontal e y e m o v em en ts will b e tested.
V oluntary o r reflexive (oculocephalic) e y e m o v em en ts will b e sc o re d but
caloric testing is not do n e. If th e patien t h a s a conjugate deviation of
th e e y e s th at can be ov erco m e by voluntary o r reflexive activity, the
sc o re will b e 1. If a patient h a s an isolated peripheral nerv e p aresis
(CN 1 1 1 , IV or VI) sc o re a 1. G a z e is te sta b le in all a p h a sic patients.
P atien ts with ocular traum a, b a n d a g e s , pre-existing blindness or other
d isorder of visual acuity or fields should b e te ste d with reflexive
m o v em en ts an d a choice m a d e by th e investigator. E stablishing eye
c o n ta ct an d th en m oving a b o u t th e patient from sid e to sid e will
o ccasionally clarify th e p re se n c e of a partial g a z e palsy.
0 = Normal
1 = Partial g a z e palsy. This s c o r e is given w h e n g a z e is
abnorm al in o n e or both e y e s, but w h e re forced
deviation or total g a z e p a re sis a re not p re sen t.
2 = F orced deviation, or total g a z e p a re s is not o v erco m e by the
o culocephalic m an e u v er.
Rev 3/24/93
31
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NIH STROKE SCALE T he NINDS t-PA S troke Trial N o . -____________ -___________
FORM 5 Pt. D ate of B irth________ /________/_____
2 of 4 H o sp ita l_____________________________ { ________-_______
D ate of E x a m ________ /________/_____
Interval: 1 [] Baseline 2[ ] 2 hours post treatment 3[ ] 24 hours post onset of symptoms ±20 minutes 4[ ] 7-10 days
5[ ] 3 months 6[ ] O the r____________________________________ (_______ )
3. V isual: Visual fields {upper and lower quadrants) are tested by
confrontation, using finger counting or visual threat a s appropriate.
Patient m ust be en co u rag ed , but if they look at the side of the moving
fingers appropriately, this ca n be sco red a s normal. If there is unilateral
blindness or enucleation, visual fields in the remaining ey e are scored.
S core 1 only if a clear-cut asym m etry, including quadrantanopia is
found. If patient is blind from any c a u se sco re 3. Double sim ultaneous
stimulation is perform ed at this point. If th ere is extinction patient
receives a 1 and the results a re u sed to answ er question 11.
0 = No visual loss
1 - Partial hem ianopia
2 = C om plete hem iariopia
3 = Bilateral hem ianopia (blind including cortical blindness)
—
4. Facial Palsy: Ask, o r u se pantom im e to en co u rag e th e patient to
show teeth or raise eyebrow s and close eyes. S co re sym m etry of
grim ace in re sp o n se to noxious stimuli in the poorly responsive or non
com prehending patient. If facial traum a/bandages, orotracheal tube,
tap e or other physical barrier o bscures the face, th e se should be
rem oved to the extent possible.
Q = Normal sym m etrical m ovem ent
1 = Minor paralysis (flattened nasolabial fold, asym m etry on
smiling)
2 = Partial paralysis (total or n e a r total paralysis of lower face)
3 - C om plete paralysis of o n e or both sid es (a b sen ce of facial
m ovem ent in the upper an d lower face)
5 & 6. M otor A rm and Leg: T he limb is placed in the appropriate
position: extend th e arm s (palm s down) 90 d eg rees (if sitting) or 45
d eg rees (if supine) and th e leg 30 d eg rees (alw ays tested supine). Drift
is scored if the arm falls before 10 sec o n d s or the leg before 5 seco n d s.
The ap h asic patient is en c o u rag e d using urgency in the voice and
pantom im e but not noxious stimulation. Each limb is tested in turn,
beginning with the non-paretic arm. Only in the c a se of am putation or
joint fusion at th e shoulder or hip m ay the sco re be ‘ '9” and the
exam iner m ust clearly write th e explanation for scoring a s a ”9".
0 = No drift, limb holds 90 (or 45) d e g re e s for full 10 seconds.
1 = Drift, Limb holds 90 (or 45) d eg rees, but drifts dow n before
full 10 seconds; d o e s not hit bed or other support.
2 = S om e effort against gravity, limb cannot g et to or maintain
(if cued) 90 (or 45) d eg rees, drifts down to bed, but h as
so m e effort against gravity.
3 -• No effort against gravity, limb falls.
4 = No m ovem ent
9 = Amputation, joint fusion explain:
5a. Left Arm
5b. R ight Arm
—
0 = No drift, leg holds 30 d e g re e s position for full 5 seconds.
1 = Drift, leg falls by th e end of the 5 sec o n d period but does
not hit bed.
2 = S o m e effort against gravity; leg falls to bed by 5 seconds,
but has so m e effort ag a in st gravity.
3 = No effort against gravity, leg fails to bed immediately.
4 = No m ovem ent
9 = Amputation, joint fusion explain:____________________
6a. Left Leg
6b. Right Leg
R ev 3/24/93
32
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NIH STROKE SCALE T he NINDS t-PA stroke Trial N o. .............. - ..........
FORM 5 Pt. Date of Birth______ / ...... !_____
3 of 4 Hospital ........ (....... -______
Date of Exam i ........./_____
Interval: 111 B aseline 2[ ] 2 ho u rs p o st tre atm en t 31 1 24 hours post o n set of sy m p to m s ±20 m inutes 41 1 7-10 days
5[] 3 m onths 6[] O th e r ...... (________ )
7. Lim b Ataxia: This item is aim ed a t finding evidence of a unilateral
cerebellar lesion. T est with e y e s open. In c a s e of visual defect, insure
testing is done in intact visual field. T he finger-nose-finger and heel-
shin tests are perform ed on both sides, and ataxia is scored only if
present out of proportion to w e ak n ess. Ataxia is ab se n t in the patient
who cannot understand or is paralyzed. Only in th e c a s e of am putation
or joint fusion m ay the item be scored "9", and th e exam iner m ust
clearly write th e explanation for not scoring. In c a s e of blindness test by
touching n o se from extended arm position.
0 ~ A bsent
1 = P rese n t in one limb
? = P resent in two limbs
If present, is ataxia in
Right arm 1 = Y es 2 - No
.9 - am putation or joint, fusion, explain
Left arm 1 - Y es 2 - No
9 - am putation or joint fusion, explain
Right leg 1 = Y es 2 ~ No
9 = am putation or joint fusion, explain
Left leg 1 = Y es 2 •* No
9 = am putation or joint fusion, explain
8. S en so ry : Sensation or grim ace to pin prick when tested, or
withdrawal from noxious stim ulus in the oblunded or ap h asic patient.
Only sensory loss attributed to stroke is scored a s abnorm al an d the
exam iner should test a s m any body are a s [arm s (not hands), legs,
trunk, face] a s n ee d ed to accurately check for hem isensory loss. A
sco re of 2, "severe or total," should only be given w hen a sev e re or total
loss of sensation can be clearly dem onstrated. Stuporous and aphasic
patients will therefore probably sco re 1 or 0. T he patient with brain
stern stroke who h a s bilateral loss of sensation is scored 2. If the
patient d o e s not respond and is quadriplegic sco re 2. Patients in com a
(item 1a-3 ) a re arbitrarily given a 2 on this item.
0 - Normal: no sensory loss.
1 “ Mild to m oderate se n so ry loss; patient feels pinprick is less
sharp or is dull on th e affected side: or th ere is a loss of
supeificial pain with pinprick but patient is aw are h e/sh e
is being touched.
2 = S evere to total sen so ty loss; patient is not aw are of being
touched in the face, arm , and leg.
9. B est L an g u a g e: A g re at deal of information about com prehension
will b e obtained during the preceding sections of th e exam ination. The
patient is ask e d to describe what is happening in th e attached picture,
to nam e the item s on the attached nam ing sh eet, and to read from the
attached list of sen ten c es. C om prehension is judged from re sp o n ses
h ere a s well a s to all of th e com m ands in th e preceding general
neurological exam . If visual loss interferes with th e tests, ask the
patient to identify objects placed in the hand, repeat, and produce
speech. T he intubated patient should b e ask e d to write. The patient in
com a (question 1 a-3 ) will arbitrarily score 3 on this item. The exam iner
m ust choose a sco re in th e patient with stupor or limited cooperation
but a score of 3 should be u sed only if the patient is m ute and follows
no one ste p com m ands.
0 = No aphasia, normal
1 = Mild to m oderate aphasia; so m e obvious io ss of fluency or
facility of com prehension, without significant limitation on
ideas expressed or form of expression. R eduction of
sp eech and/or com prehension, however, m ak e s
conversation about provided m aterial difficult or
im possible. For exam ple in conversation ab o u t provided
m aterials exam iner ca n identify picture o r nam ing card
from patient's resp o n se.
2 - S evere aphasia: all com m unication is through fragm entary
expression; great need for inference, questioning, and guessing
by the listener. R ange of information th at ca n b e exchanged is
limited; listener carries burden of com m unication. Examiner
cannot identify m aterials provided from patient response.
3 - Mute, global aphasia; no u sab le sp ee ch or auditory
com prehension.
10. D ysarthria: If patient is thought to be normal an ad e q u ate sam ple
of sp ee ch m ust be obtained by asking patient to read or repeat words
from the attached list. If th e patient h a s sev e re aphasia, the clarity of
articulation of spontaneous sp ee ch can be rated. Only if the patient is
intubated o r h as other physical barrier to producing speech, m ay the
item be scored "9''. an d th e exam iner m ust clearly write an explanation
for not scoring. Do not tell the patient why ho/she is being tested.
0 = Normal
1 = Mild to m oderate; patient slurs at lea st so m e w ords and, at
worst, can be understood with so m e difficulty.
2 = Severe; patient's sp e e c h is so slurred a s to b e unintelligible
in the ab se n ce of or out of proportion to any dysphasia,
or is m ute/anarthric.
9 - Intubated or other physical barrier,
explain
—
R ev 3/24/93
33
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N IH S T R O K E S C A L E T h e NINDS t-PA S tro k e Trial N o . -____________ -___________
FORM 5 Pt. D ate of B ir th _____ / ........ /___ ___
4 of 4 H o s p ita l .............................. ( _-_______
D ate of E x a m /_......... /.............
Interval: 1 [] Baseline 2[ 1 2 hours post treatm ent 3[ ] 24 hours post onset of sym ptom s ±20 minutes 4[ ] 7-10 days
5 [] 3 months 6 [] O ther . ....... (............... )
11. E x tin ctio n a n d In a tte n tio n (fo rm erly N e g le ct): Sufficient
information to identify n eg le ct m ay b e o b tain ed dining th e prior testing.
If the patient h a s a s e v e re visual lo ss preventing visual double
sim ultaneous stim ulation, a n d th e c u ta n e o u s stimuli a re norm al, the
sco re is norm al. If th e patient h a s a p h a sia but d o e s a p p e a r to atten d lo
both sides, th e s c o re is norm al. T he p re s e n c e of visual spatial negiecl
or an o sa g n o sia m ay also b e tak e n a s ev id e n ce of abnorm ality. S ince
th e abnorm ality is sc o re d only if p re sen t, th e item is n ev e r unteslable.
0 = No abnormality.
1 = Visual, tactile, auditory, spatial, o r p erso n al inattention or
extinction lo bilateral sim u ltan e o u s stim ulation in o n e of
th e sen so ry m odalities.
2 - Profound hem i-inattention o r hem i-inattention to m o re than
o n e m odality. D o e s not reco g n ize ow n h an d or orients
to only o n e sid e of s p a c e .
Additional item , not a part of th e NIH S tro k e S c a le sco re.
A D istal M otor F u n c tio n : T h e p atien t's hand is held up at the forearm
by the exam iner an d patient is a sk e d to extend h is/h er fingers a s m uch
a s possible. If th e patient c a n ’ t o r d o e sn 't extend the fingers the
exam iner p la c e s th e fingers in full extension an d o b se rv e s for any
flexion m ovem ent for 5 se c o n d s. T he p atien t's first attem p ts only are
graded. Repetition of th e instructions or of th e testing is prohibited.
0 = Normal (No flexion afte r 5 se c o n d s)
1 = At lea st so m e ex ten sio n afte r 5 s e c o n d s, but not fully extended.
Any m ovem ent of th e fingers which is not co m m an d is not
scored.
2 - No voluntary extension afte r 5 se c o n d s. M ovem ents of th e fingers
at an o th er tim e a re not sco red .
a. Left Arm
b. R ig h t Arm
12 . (_________
Person Administering Scale Code
R ev 3/24/93
34
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Q<
Q
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
You know how.
Down to earth.
I got home from work.
Near the table in the dining
room.
They heard him speak on the
radio last night.
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
MAMA
TIP - TOP
FIFTY-FIFTY
THANKS
HUCKLEBERRY
BASEBALL PLAYER
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
Appendix B.
MINI-MENTAL
STATE EXAMINATION
(MMSE)
Patient Name:
Rater Name:
Date:
A ctiv ity Score
O R IE N T A T IO N - one point fo r each answ er
Ask: “ W h a t is the: (y e a r){ se a so n )(d a tc )(d a y )(m o rith )? ”
Ask: “ W here are we: (state)(couiity)('tovvn)(hospital)(floor)?'"
R E G IS T R A T IO N score 1,2,3 poin ts accord in g to how m any are rep eated
N am e th ree objects: G ive the p atient one second to say each.
A sk the p atien t to: repeat all three after you have said them .
R epeat them until the patient learns all three.
A T T E N T IO N A N D C A L C U L A T IO N - one point for each correct subtraction
A sk th e p atien t to: begin from 100 and count backw ards by 7.
Stop after 5 answ ers. (93, 86, 79, 72, 65)
R E C A L L - on e poin t for each correct answ er
A sk the p atien t to: nam e the three objects from above.
L A N G U A G E
Ask th e p atien t to: identify and nam e a pencil and a watch. (2 points)
A sk th e p atien t to: repeat the phrase “N o ifs, ands, or buts.” {1 point)
A sk the p atien t to: “T ak e a p a p er in your right hand, fold it in h a lf
and put it on the floor “ {1 point fo r each task com pleted properly)
A sk the patien t to: read and obey the follow ing: “C lose your eyes.” (1 point)
Ask th e p atien t to: w rite a sentence. (1 point)
Ask th e patien t to: copy a com plex diagram o f tw o interlocking pentagons. ( 1 point )
Folstein M F, Folstein SE, M cH ugh PR. “M ini-m ental state.” A practical m ethod for grading the cognitive state o f
patients for the clinician.
J Psychiatr Res. 1975;12:189-198.
T O T A L (0 30):
References
Proddedby the Internet Stroke Center— www.strokecenter.org
39
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
Appendix C.
THE Patient Name:
BA RTH EL Rater Name:
IN D EX Date:
Activity Score
F E E D IN G
0 — u n ab le
5 ~ n e ed s h e lp cu ttin g , sp re ad in g b u tte r, e tc., o r req u ires m o d ified diet
10 ~ in d e p e n d e n t
B A T H IN G
0 — d e p e n d e n t
5 in d e p e n d e n t (o r in show er)
G R O O M IN G
0 n e e d s to h elp w ith p erso n al care
5 ~ in d e p e n d en t face/h a ir/te elh /sh a v in g (im p lem e n ts p ro v id ed )
D R E S S IN G
0 -- d e p e n d e n t
5 — n e ed s h elp but can do a b o u t h a lf u n aid ed
10 ~ in d e p e n d e n t (in c lu d in g b u tto n s, z ip s, laces, etc.)
BOWELS
0 — in c o n tin e n t (o r n e ed s to be g iv en en em as)
5 o c ca sio n a l a c c id e n t
10 - c o n tin e n t
B L A D D E R
0 — in c o n tin e n t, o r cath etcrix e d and u n a b le to m an ag e alo n e
5 ~ o c c a sio n a l accid en t
! 0 — c o n tin e n t
T O IL E T U S E
0 ~ d e p en d e n t
5 ~ n e ed s so m e h e lp , but can do so m eth in g alone
10 = in d e p e n d en t (o n an d off, d ressin g , w iping)
T R A N S F E R S (B E D T O C H A IR A N D B A C K )
0 “ u n a b le , n o sittin g b a lan ce
5 ~ m a jo r h e lp (o n e o r tw o people, p h y sical), can sit
10 = m in o r help (v erb al o r physical)
1 5 = in d e p e n d en t
M O B IL IT Y (O N L E V E L S U R F A C E S )
0 = im m o b ile o r < 50 y ard s
5 ~ w h e elc h a ir in d e p e n d en t, in clu d in g c o rn ers, > 50 yards
10 — w alk s w ith help o f one p e rso n (v erb al or p h y sical) > 50 yards
15 = in d e p e n d en t (b u t m ay use an y aid; fo r e x am p le, stick ) > 50 y ard s
S T A IR S
0 ~ u n a b le
5 — n eed s h e lp (v e rb a l, p h y sical, c arry in g aid)
10 ~ in d e p e n d en t
T O T A L (0 -100):
Proyfclerf by tbe Internet Stroke Center — www.strokecef7ter.org
40
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
The Barthel ADL Index: Guidelines
1. T h e index sh o u ld be used as a record o f what a patient does, not as a reco rd o f w hat a patient could do.
2. T he m ain aint is to estab lish degree o f independence from any help, physical or verbal, how ever m inor
and for w hatever reason.
3. T he need fo r su p erv isio n venders the patient not independent.
4. A patient's p erfo rm an ce should be established using the best available evidence. A sking the patient,
■friends/relatives and nurses are the usual sources, but direct observation and com m on sense are also
im portant. H o w ev e r d ire c t testing is not needed.
5. U sually th e patien t's p erform ance over the preceding 24-48 hours is im portant, but occasionally longer
periods w ill b e relevant.
6. M iddle categ o ries im p ly that the patient supplies over 50 per cent o f the effort.
7. U se o f aids to be independent is allow ed.
References
M ahoney FI, B arthel D. “F unctional evaluation: the B arthel Index.”
Maryland Stale M edical Journal 1965; 14:56-61. U sed with perm ission.
Loew en SC , A nderson BA . “P red icto rs o f stroke outcom e using objective m easurem ent scales.”
Stroke. 1 9 9 0 ;2 1 :7 8 -8 1 .
G resham G E, Phillips T F , Labi M L. “ A D L status in stroke: relative m erits o f three standard indexes.”
Arch Phys M ed Rehabil. 1 9 8 0 :6 1 :355-358.
C ollin C, W ade D T, D avies S, H o m e V. “The Barthel A D L Index: a reliability study.”
lo t Disability Study. 1 9 8 8 ;1 0 :6 1 -6 3 .
Copyright Information______________________________________________________
T he M aryland State M edical S o ciety holds the copyright for the B arthel Index. It m ay be used freely fo r no n
com m ercial p urposes w ith the fo llow ing citation:
M ahoney FI, B arthel D. “ Functional evaluation: the B arthel Index.”
M aryland State M ed Journal 1965;14:56-61. Used with perm ission.
Perm ission is required to m odify the B arthel Index or to use it for com m ercial purposes.
Provided by the Internet Stroke Center — www.strokecenter.org
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
Appendix D.
MODIFIED Patient Name:
RANKIN Rater Name: _ _... ......................................
SCALE (MRS) Date: I ____________________________
Score Description ________________
0 N o sym ptom s at all
1 N o significant disability despite sym ptom s; able to carry out all usual duties and activities
2 S light disability; unable to carry out all previous activities, but able to look after own affairs
w ithout assistance
3 M oderate disability; requiring som e help, but able to w alk w ithout assistance
4 M oderately severe disability; unable to w alk w ithout assistance and unable to attend to ow n bodily
needs w ithout assistance
5 Severe disability; bedridden, incontinent and requiring constant nursing care and attention
6 D ead
TOTAL (0-6):
References
Rankin J. “ C erebral vascular accidents in patients over the age o f 60.”
Scott M e d J 1957;2:200-15
B onita R, B eaglehole R. “M odification, o f Rankin Scale: R ecovery o f m otor function after stroke.”
S tro ke 1988 D e c;l9 (1 2 ):l4 9 7 ~ l5 0 0
V an Swieten JC, K oudstaal PJ, V isser M C, Schouten HJ, van G ijn J. “Interobserver agreem ent for the assessm ent o f
handicap in stroke patients.”
S tro ke 1988;19<5):604-7
Provided by the Internet Stroke Center — www.strokecenter.org
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
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Chang, Chia-Chen Megan
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Core Title
Development and evaluation of standardized stroke outcome measures in a population of stroke patients in rural China
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Applied Biostatistics and Epidemiology
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