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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
KARNATAKA, BANGALORE
ANNEXURE-II
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
1. NAME OF THE CANDIDATE RACHITA .K.M
AND ADDRESS C/O Mr.MALLESH K.M
DO/N 289,22ND CROSS,’D’Block,
J.P.NAGAR
MYSORE-5700024.
2. NAME OF THE INSTITUTION The Oxford college of Physiotherapy
J. P. Nagar, 1st Phase
BANGALORE-78
3. COURSE OF STUDY AND Master in Physiotherapy
SUBJECT Neurological and Psychosomatic disorder
4. DATE OF ADMISSION TO THE 1/6/2007
COURSE
5. TITLE OF THE STUDY
“ANALYSIS OF THE PSYCHOMETRIC PROPERTIES OF STROKE SPECIFIC
QUALITY OF LIFE SCALE ON STROKE SUBJECTS”
6 BRIEF RESUME OF THE INTENDED WORK
6.1.NEED OF THE STUDY
Stroke is an acute onset of neurological dysfunction due to an abnormality in cerebral
circulation with resultant signs and symptoms that correspond to involvement of focal areas of
the brain. 1
Even though stroke being the third commonest cause of death world wide, according to the
Asian Acute stroke advisory panel, India is still ranked among the countries where the
information on stroke is minimal.2
. According to the International journal of stroke, Vol 1, AUGUST 2006,Worldwide
approximately 20 million people suffer fro stroke each year; 5 million die as a consequence of
stroke and 15 million will survive of those who survive, 5 million will be disabled by their
stroke.3
It is not important how long a person lives it is rather important to know how a person lives,
hence forth the ICF (formerly ICIDH, 1990,AND ICIDH -2.1999) was subsequently developed
in recognition of the need to describe nonfatal health related states and outcome for the purpose
of quantifying population “health”. The final component of the WHO biopsychosocial model
encompasses health perceptions or what has come to be known in the health and disability
literature as health related quality of life (HRQOL). 4
. Hence physical therapy interventions in recent years have started to assess the quality of
life of stroke subjects. These measures of the QOL summarize the judgments people make to
describe their experience of health and illness.
A true measure of QOL includes an affective or self-evaluative component. WHO (1995)
defined QOL as “An individuals perception of their position in life in the context of the culture
and value systems in which they live and in relation to their goals, expectations, standards and
concern It is a broad ranging concept affected in a complex way by the persons’ physical
health, psychological state and level of independence, social relationships and their relationship
to salient features of their environment”5.
A good QOL measurement should include
1.Targeted measurement
2.QOL in policy development
3.Measuring QOL from the patients perspective
4. Patient centered QOL measure for treatment.
It is important to check
Irrelevant variance specific to disease
Construct under representation of secondary complication of the disease. 6
According to the studies done previously on certain generic measures and stroke measures
the few available generic measures available to assess QOL in stroke included 6
Stroke Impact Profile, Nottingham Health Profile, EuroQol, Health utilities Index, London
handicap Scale. And stroke specific measures included Frennchay activities Index, Neimi QOL
scale, Ferrans and powers QOL index stroke Version, and stroke Adapted sickness impact
Profile6.
Generic measures enabled comparisons between groups with a diverse range of illnesses,
they could not focus on the problems of a specific condition and was not sensitive to changes in
QOL.6
Condition specific measures were not found to have patient centered methods in their
development. Acceptability of these measures was not pre tested. And Floor and ceiling effect
were not reported for any measures. Hence it was believed to detect patient centered approach
with rigorous psychometric testing essential.6
Any patient oriented evaluation should include certain tools for measurement like
1. Validity: The degree to which a useful interpretation can be inferred from a measurement.
2. Reliability: The consistency or repeatability of measurements is error free and the degree to
which repeated measurement will agree.
3. Unidimensionality: The property of having only one dimension .An out come measure,
which assess only one single variable.
4. Hierarchy: Items that are used to represent a construct should form a hierarchy of difficulty,
ranging from least difficult for the respondent to perform to the most difficult to perform. And
thus comparing this with theoretical ordering and the result can be treated as evidence of
construct validity.7.
5. Interval scaling: It is to change ordinal scales to interval scale, based on equal distribution of
scores.
6. Targeting: The appropriateness for the level of difficulty of the items for the sample 7
The recent Stroke specific quality of life which has been widely used to assess the quality of
life in stroke patient was developed inductively with stroke survivors in 1999 consist of 12
domains, which is shown to have excellent content validity. Compared with other common
generic HRQOL measures, the SSQOL has a broader coverage of function typically affected by
stroke and ask questions in these areas in a way that is meaningful to stroke patients.8
Even though SSQOL is found to be reliable and valid since its development,
certain studies still say there is further validation required with larger population as it is said to
have some items that does not match the response set. The SSQOL has found to have an internal
consistency ranging from adequate to excellent, for work productivity to self-care. The overall
construct validity is found to have 0.65.
Therefore it is necessary to analyze for certain other properties like unidimensionality.
Hierarchy, Interval scaling and Targeting, which is done using a Rasch analysis. Rasch
analysis originated in the areas of education, psychology. Scientist in the rehabilitation field in
the last few years have started to publish studies showing how useful could RA be in
reconsidering old questionnaires, improving their content and formulation or reassessing their
validity.10.
Hence this study intends to assess all the psychometric properties of improved scoring and
interpretation of SSQOL and indeed to improve the clinical practice for a better quality of life
assessment and rehabilitation.
6.2 REVIEW OF LITERATURE.
Health and Quality of life
1. World Health Organization (WHO, 1948) defined health as “a state of complete physical,
mental, and social well-being and not merely the absence of disease or infirmity”11
Quality of life after stroke
2. Saladin LK (2000) evidenced that the ‘Quality of life’ measures fairly accurately represent
the patient’s own perception of his/ her functioning and general health. Taking into
consideration the way in which patients view their own health situation is the most important
element of patient- centered health care. Recording self-reported QOL must be integrated
element of post-stroke evaluation and treatment.8
3. Buck D, Jacoby A, Massey A and Ford G (2000) stated that the assessment of quality of life
(QOL) after stroke is becoming common with the recognition that evaluation of treatment
should include quality as well as quantity of survival. Because of this, there has been a growing
interest in tests that measure the health related QOL of post-stroke patients. 5
4. Hopman W M. (2003) stated in her study that research evidence indicates that both inpatient
and outpatient stroke rehabilitation helps stroke survivors maximize their health-related quality
of life (HRQOL), including physical, cognitive, emotional, and social aspects but less is known
about the HRQOL of stroke patients after discharge from rehabilitation. 12
Application of SSQOL
5.Deborah buck et al, 2003,evaluation with various scales, Frenchay activites index, Neimi
QOL scale, Ferrans and powers QOL index stroke version, Stroke adapted sickness impact
profile believed a patient centered stroke scale development to be essential.5
6. Samuel Wiebe et al, 2001,comparing the general versus stroke specific outcome measure
showed stroke instrument (mean=0.57) more significant compared to generic (mean=0.39). 13
Application of Rasch analysis
7.L.Tesio et al,(2007)analyzed the Rasch analysis on rehabilitation medicine and observed
responses in agreement with the theoretical requirements of measurement.10
8. Alan Tennant et al, emphasized how Rasch analysis has been applied in the development of
needs based measures in order to ensure that they provide unidimensionality criteria. It ensured
that scales are based on same measurement model and that they fit the Rasch model it is possible
for QOL scores to be compared across diseases by means of co calibration and item banking.
6.3 OBJECTIVES OF THE STUDY
1. .To evaluate the psychometric properties of SSQOL scale on chronic stroke patients.
6.4 HYPOTHESIS:
(A) NULL HYPOTHESIS: SSQOL does not exhibit the psychometric properties in chronic
stroke subjects.
(B) ALTERNATE HYPOTHESIS: SSQOL exhibit the psychometric properties in chronic
stroke subjects.
7
MATERIALS AND METHODS
7.1 STUDY DESIGN AND SETTING
7.1.1 STUDY DESIGN
A cross sectional study to find out the psychometric properties of stroke specific quality of life
scale among the persons with chronic stroke.
7.1.2 SOURCE OF DATA
Samples for the study will be collected from:
1. Agadi Centre for Physical Medicine And Neurorehabilitation, Bangalore.
2. Mobility India, Bangalore.
3. The Oxford Rehabilitation centre, Bangalore
4. Jayanagar General Hospital, Bangalore
7.2 METHODOLOGY
7.2.1POPULATION
Both male and female persons with chronic stroke form the population.
7.2.2 SELECTION CREITERIA
1. Inclusion criteria
a. Patients with chronic stroke, 1 to 5 years of duration
b. Age group of 50 to 70
c. MMSE Score 24 and above
d. Patients suffering from first ever unilateral stroke
2. Exclusion criteria
1. Patients suffering from the following conditions
Heart diseases
Diseases of the respiratory system
Severe osteoarthritis of knee and hip joints
Fracture of bones of lower limb
Any progressive neurological diseases
Any immunosuppressive diseases.
Which can limit the functional activities
7.2.3 SAMPLING METHOD AND SAMPLE SIZE
a. Sampling method: Sequential sampling.
b. Sample size: 75subjects with stroke.
7.2..4 PROCEDURE
The purpose of the study will be explained to all the subjects who will volunteer to take part
in the study. The informed consent will be taken in his or her own native language followed by
demographic data clear from each subject. All subjects will be assessed with a specific
proforma. The subjects will be selected based on inclusion criteria. A total of 75 subjects, both
males and females will be selected for the study.
The selected subjects will be interviewed with stroke specific quality of life questionnaire.
This is a 49-item and 12-domain questionnaire. The maximum score is 245 and the minimum
score is 49. The domains assessed include energy, family roles, language, mobility, mood,
personality, self-care, social scores, thinking, upper extremity function, vision and work or
productivity. After the assessment the scores obtained will be taken note off.
Once the scores are collected the scores will be analyzed by Rasch analysis using the
ministeps reduced version of winsteps to evaluate the psychometric properties of SSQOL scale.
The ministeps program analyzes the range of scores of SSQOL and interprets the data for the
following properties.
a. Unidimensionality: This analyses the construct validity of individual domains i.e
whether all domains measures only one property by using Fit Statistics. This is
conceptually similar to a chi square analysis.
b. Hierarchy: This checks whether the ordering of the items that is presently followed is
correctly ordered. This is analyzed using item difficulty.
c. Interval scaling: The number of different strata of subjects present is calculated for
the subjects.
d. Targeting: This measures whether the set of items measured is at the appropriate
level of difficulty to capture the limitations in functional ability.
a. DURATION AND FOLLOW UP
The study is cross sectional. So, there will be only one session of assessment and no follow-
up is needed.
b. MATERIALS REQUIRED
Stroke specific quality of life questionnaire
Mini mental status examination
7.3. OUTCOME MEASURES AND STATISTICAL ANALYSIS
7.3.1 OUTCOME MEASURES
1. The health related quality of life in persons with stroke is assessed with the stroke
specific quality of life (SS-QOL) questionnaire.
2. The scores of SSQOL analyzed for psychometric properties.
7.3.2 STATISTICAL ANALYSIS
a. DATA MANAGEMENT
The scores obtained by the SS-QOL questionnaire from male and female subjects are
arranged according to the difficulty faced by the subject from easy to difficult. These scores
indicate their level of health related quality of life. Then the results are taken by ministeps to
further evaluate for the psychometric properties.
b. DATA ANALYSIS
Unidimensionality will be analyzed by Fit Statistics, Hierarchy will be analyzed by item
difficulty level which will be expressed as a Logit, Interval scaling will be done through item
and person separation by calculating the separation Index and Targeting will be calculated by
finding the deviation from the average difficulty level across domains.
CONCLUSION
This study is to evaluate the psychometric properties of Stroke specific quality of life in chronic
stroke using Rasch analysis for obtaining valid and reliable scale for rehabilitation use.
7.4 a) Does the study require any interventions to be conducted on patients or other
humans or animals?
This study does not require any intervention. But it requires assessment i.e. stroke specific
quality of life questionnaire to evaluate the psychometric properties for rehabilitation use. The
subjects will be asked to respond for the questions asked and the score are statistically managed
using Winsteps. All the above investigation procedures will not cause any harm to the individual
subjects.
7.4 b). Has the ethical consent for the study has been obtained from the institution?
Yes, it has been obtained from the institution. Ethical clearance form is attached. (Appendix I).
An informed consent will be obtained prior to study from each subject in his or her native
language (Appendix II).
8. REFERENCES
1. Susan B.O’Sullivan, physical rehabilitation.4th edition:520.
2. Asian Acute stroke advisory panel, India
3. International journal of stroke, Vol 1, AUGUST 2006.
4. DoylePJ et al, Measuring Health Outcomes in Stroke Survivors, Arch Phys Med rehabil
2002:83 suppl 2:s39-43.
5. Deborah Buck, Evaluation of Measures Used to assess quality of life after Stroke, Stoke,
2000; 31:2004-2010.
6.David S et al Quality of life measurement in rehabilitation medicine building an agenda for
the future, Arch phys medicine rehabili, 2002:83;suppl 2-s1-3.
7. Dunean PW et al, Rasch analysis of a new stroke specific outcome scale: the Stroke Impact
Scale, Arch phy med rehabili 2003,vol 84,july.
8. Linda S Williams et al, Development of a stroke specific quality of a stroke specific Quality
of Life Scale,Stroke;1999:30:1362-1369.
9.www.winsteps.com
10. L.Tesio et al, Rehabilitation and outcome measurement: where is Rasch analysis going?
Eura medicophysio 2007;43;417-26.
11. WHO, WHOQOL GROUP. The World Health Organization Quality of Life Assessment
(WHOQOL): position paper from the World Health Organization. Soc Sci Med 1995;41:1403-9.
12. Hopman WM. and Verner J. Quality of Life During and After Inpatient Stroke
Rehabilitation. Stroke 2003; 34;801-805.
13. Kaplan RM, Quality of Life:An outcome perspective, Arch phys Med Rehabili
2002:83:suppl 2:s44-50
.
14. Stroke Engine. www. Stroke Engine.com
15Julia Warner et al, Sex differences in Stroke recovery and SSQOL, Stroke 2007:38;2541.
16. Dunean PW et al, Rasch analysis of a new stroke specific outcome scale: the Stroke Impact
Scale, Arch phy med rehabili 2003,vol 84,july.
17. Linda S Williams et al, Reliability and telephone validity of the ssqol, Stroke, 3,339-b
Dianne J rusell et al, Improved scaling of the Gross Motor function measure for Children with
cerebral palsy: evidence of Reliability and Validity, Physical therapy, vol 80,November 9, 2000.
18. Strum JW, Donnan GA, Dewey HM, Macdonell RAL, Gilligan AK, Srikanth V. et. al.
Quality of Life After Stroke: The North East Melbourne Stroke Incidence Study (NEMESIS).
Stroke 2004; 35; 2340-5
9. Signature of the candidate
10. Remarks of the guide
11. NAME AND DESIGNATION OF
11.1 Guide Mr. K.G.KIRUBAKARAN, MPT
Principal
11.2 Signature
11.3 Co-guide
11.4 Signature
11.5 Head of the Department Mr. R. VASANTHAN, MPT
Assistant Professor
11.6 Signature
12. 12.1 Remarks of chairman and
principal Mr. K.G.KIRUBAKARAN, MPT
Principal
12.2 Signature
APPENDIX-I
THE OXFORD COLLEGE OF PHYSIOTHERAPY
I PHASE, J.P Nagar, Bangalore-560078
Review Board on Ethics for Research
We here by declare that the project titled, “ ANALYSIS OF THE PSYCHOMETRIC
PROPERTIES OF STROKE SPECIFIC QUALITY OF LIFE SCALE ON STROKE
SUBJECTS’’.
Carried out by Ms.RACHITA.K.M. of I Year M.P.T has been brought forward for scrutiny to
the board members. After analyzing the Objectives, subjects involved and the methodology of
the project, the following conclusions were drawn.
The project does not have any mental or physical harm to the subjects involved and there
no risks involve any mental or physical harm to the subjects involved and there no risks
involved with the study. The performance of the study procedure will not cause any injury to
the subjects. The board has evaluated and confirmed that the experimenter is trained and
qualified in giving the intervention and / or measuring outcome. The informed consent from
prepared ensures that, the experimenter explains the procedure of the study to the subjects,
their voluntary participation is confirmed and the identification of subjects is maintained
confidential.
Further more the finding of the study will benefit similar subjects, the profession and the
society.
Hence the review board has no objections on the conduct of the study.
Chair of Departmental Review Board Project Guide
Principal
APPENDIX-II
CONSENT FORM
Title of Project:
“ANALYSIS OF THE PSYCHOMETRIC PROPERTIES OF STROKE SPEIFIC
QUALITY OF LIFE SCALE ON STROKE SUBJECTS’’.
Investigator: Ms.RACHITA K.M.
I, Mr. / Mrs. …………………………………………………, freely and voluntarily agree to
participate in the research project.
Purpose of Study
I have been informed that this study is going to assess my quality of life. This study
will help physiotherapists to determine whether the SSQOL outcome measure used frequently
is a valid measure to assess quality of life in chronic stroke subjects.
Procedure
I understand that Ms RACHITA.K.M will assess my quality of life with certain sets of
questions about my mobility, mood, personality, self-care, thinking etc. Besides, I will also be
asked certain questions regarding my memory, attention, intelligence etc. that I will have to
answer. The questionnaire is explained to me in detail and it will take approximately 20 to 30
minutes to complete the procedure. All assessments can be done in one day and there is no
needs for follow up.
Risk and Discomforts
I understand that I won’t have any risk or discomfort during the procedures. My
attendant will be allowed to stay with me during the interview for my assistance in case I may
have any difficulty in answering.
Benefits
I understand that my participation in the study will help to assess the quality of my life
and it will have no direct benefit to me. The major potential benefit is to find out the validity of
SSQOL, which is used in persons with chronic stroke. The recorded values will help the study.
Confidentiality
I understand that medical information produced by this study will become part of my
personal record and will be subjected to the confidentially and privacy regulations of Hospital
and rehabilitation centre Authority. If the data are used for publication in the medical literature
or for teaching purpose, no names will be used, and other identifiers, such as photographs and
audio or videotapes, will be used only with my special written permission, after I confirming
that my facial and other identifying features will be covered or obliterated in the reproduction.
I understand that I will see the photographs and videotapes and listen to the audiotapes before
giving this permission.
Request for More Information
I understand that I may ask more questions about the study at any time. Ms Rachita
K.M at +919448365039 is available to answer my questions or concerns. A copy of this
consent form will be given to me for my perusal.
Refusal or Withdrawal of Participation
I understand that my participation is voluntary and that I am free to withdraw at
anytime, without giving my reason, without my medical care or legal rights being affected.
Injury Statement
I understand that in the unlikely event of injury resulting directly from my participation
in this study, if such injury is reported promptly, medical treatment would be available to me.
No further compensation would be provided. I understand that my agreement to participate in
this study does not waive any of my legal rights. I confirm that the investigator has explained
to me the purpose of the research, the study procedures that I will undergo, and the possible
risks and discomforts as well as benefits that I may experience. I have read and I understand
the contents of this consent form.
…………………………….. ………………. …………………….
Name of patient /Legal Guardian Date Signature
…………………………………… …………………… …………………….......
Name of Witness Date Signature
I have explained to Mr. /Mrs. …………………………………………………………………..
in detail the purpose of the research procedure and the possible risks and benefits to the best of
my abilities to which the subject has consented to participate.
…………………………….. ………………….. ……………………….
Researcher Date Signature
APPENDIX-III
SUBJECT RECRUITMENT FORM
Name:
Age:
Sex:
ADDRESS: Mr. / Ms. ……………………………………………..
…………………………………………………………………….
…………………………………………………………………….
………………………………… Pin ……………………………..
Phone number: …………………… Mobile: ………………………..
Type of stroke: infarct/ haemorrhage CT/MRI. ……………………..
Side of hemiplegia: left/ right
Duration:
Social support:
INCLUSION CRITERIA Yes No
1. Whether the subject is having chronic stroke (1 to5 years of duration)
Yes No
2. Whether the subject’s age is between 50 to 70 years?
Yes No
c. Whether the subject’s MMSE Score is 24 and above?
Yes No
d. Whether the subject is suffering from first ever stroke?
EXCLUSION CRITERIA
1. Patients suffering from the following conditions
Yes No
heart diseases
Yes No
diseases of the respiratory system
Yes No
severe osteoarthritis of knee and hip joints
Yes No
fracture of bones of lower limb
Yes No
any progressive neurological diseases
Yes No
any immunosuppressive diseases.
DATE: ………………………………...
TIME: …………………………………
SUBJECT ID: …………………………
APPENDIX-IV
DATA PROFORMA
Name:
Age:
Sex:
ID No. ..............................
Date of assessment:
ADDRESS: Mr. / Ms. ……………………………………………..
…………………………………………………………………….
…………………………………………………………………….
………………………………… Pin ……………………………..
Phone number: …………………… Mobile: ………………………..
Type of stroke: infarct/ haemorrhage CT/MRI. ……………………..
Side of hemiplegia: left/ right
Duration:
Social support:
Comorbidity:
Premorbidity:
Base line MMSE scores: ……../30
Stroke specific quality of life questionnaire (SS-QOL)
Sl. no. ITEMS SCORE
1. Energy
2. Family roles
3. Language
4. Mobility
5. Mood
6. Personality
7. Self care
8. Social roles
9. Thinking
10. Upper extremity function
11. Vision
12. Work/ productivity
TOTAL SCORE
APPENDIX-V
Stroke specific quality of life questionnaire (SS-QOL)
ITEMS SCORE
Energy ………
Family roles ………
Language ………
Mobility ………
Mood ………
Personality ………
Self care ………
Social roles ………
Thinking ………
Upper extremity function ………
Vision ………
Work/ productivity ………
Total score ………/245
