Original Article

The Development of ‘Quality of Life Instrument for

Indian Diabetes Patients (QOLID) : A Validation and
Reliability Study in Middle and Higher Income Groups
Jitender Nagpal*, Arvind Kumar**, Sonia Kakar***, Abhishek Bhartia#

Abstract
Purpose: To develop a reliable and valid quality of life questionnaire for Indian patients with diabetes.
Methods: A draft of 75 questions was prepared on the basis of expert opinion, focus group discussions, review
of existing literature and detailed semi-structured interviews of patients with diabetes with the intention of
including all aspects of diabetes-specific and quality of life considered relevant by patients and care providers
to enable constrict validity. A Stage 2 questionnaire was then prepared with 13 domains and 54 items (questions)
after expert panel review for obvious irrelevance and duplication of issues. It was administered to 150 participants
visiting a diabetes center at New Delhi. Factor analysis was done using principal component method with varimax
rotation. Reliability analysis was done by calculating Cronbach’s Alpha. For evaluating concordant validity the
questionnaire was co-administered with DQL-CTQ to 30 participants. The discriminant validity of the questionnaire
was tested using ‘t’ test for metabolic control, co-morbidities, insulin use and gender.
Results: Using principal component method 8 domains were identified on the basis of an apriori hypothesis
and the scree plot. These 8 domains explained 49.9% of the total variation. 34 items (questions) were selected
to represent these domains on the basis of extraction communality, factor loading, inter-item and item-total
correlations. The final questionnaire has an Overall Cronbach’s Alpha value of 0.894 (subscale- 0.55 to 0.85)
showing high internal consistency. The questionnaire showed good concordance (product moment correlation
0.724; p=0.001; subscale correlation – 0.457 to 0.779) with the DQL-CTQ. The overall standardized questionnaire
score showed good responsiveness to metabolic control and co-morbidities establishing discriminant validity.
Conclusion: The final version of questionnaire with 8 domains and 34 items is a reliable and valid tool for
assessment of quality of life of Indian patients with diabetes.
Abbreviations: WHOQOL : World Health Organization Quality of Life assessment; SF-36 : Short Form- 36
questionnare; DQLCT-R : Diabetes Quality of Life Clinical Trial Revised version; ADDQoL : Audit of Diabetes
Dependent Quality of Life; DQoL : Diabetes Quality of Life; PGI : Patient Generated Index; BMI : Body Mass
Index; CAD : Coronary Artery Disease; PDSG : Prospective Diabetes Study Group

Introduction its perception of quality of life influenced by their ethnicity,

Q uality of life has been defined by WHO as ‘Quality of life is
defined as individuals’ perceptions 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
concerns. ‘Quality of life’ evaluation has emerged as an important
outcome measure for chronic disease management. In this
context, a large variety of generic1 and disease specific2-7 quality
of life assessment tools have been validated and evaluated in
diverse population settings. It is increasingly recognized that
in diabetes psychosocial factors have an important impact on
self care, acceptance of therapeutic regimens and treatment
success8,9 and that, metabolic measures like glycemic control are
poorly correlated with quality of life10-12 necessitating separate
assessment. In turn, management models for diabetes that
include strategies to identify and enhance patient’s health-related
quality of life issues have the potential to improve compliance
and hence their metabolic status. Quality of life is an individual
perception13 and each particular subset of patients differs in
Attending Consultant, **Attending Consultant, ***Senior Dietician,
*
culture, education, income, etc. Most of the existing quality of
life questionnaires have been developed in western population,2-5
which are socially, culturally and economically different from
Indian participants and work from India on the subject is
scarce. One such diabetes specific instrument developed and
validated in India recently restricts itself to the psychosocial
aspect of quality of life.6 In the absence of a comprehensive and
validated diabetes specific quality of life instrument in India, we
conducted this study to develop a reliable and valid structured
questionnaire for assessment of quality of life in Indian diabetic
patients.
Materials and Methods
Item generation
A summary of the study design is presented in Fig. 1. As
depicted to generate a comprehensive set of items relevant
to Indian patients with type 2 diabetes we held intensive
discussions with the faculty and diabetologists at the Diabetes
Center, Sitaram Bhartia Institute of Science and Research after

Director, Sitaram Bhartia Institute of Science and Research, B-16,

# approval by the institutional ethics committee. Interviews were
Qutab Institutional Area, New Delhi-110016, India. conducted on 20 consecutive patients with type 2 diabetes
Received: 09.02.2009; Accepted: 29.12.2009 and they were asked to identify problem areas affecting their

© JAPI • may 2010 • VOL. 58 295

            
     
       
     
        
         
   
       
      
   
   
  –   
•    
•    
•        
•
•
      
     
•      
      
       
       
  
      
      
 
     
      
Fig. 1 : Summary of Study Design
quality of life using a semi-structured approach based on Patient
Generated Index (PGI).14 This approach allowed the participants
to identify areas which they perceive to be their primary source
of worry. In this step the participants were asked to rate these
areas on a scale of 1 to 10 to clarify how severe was the problem in
comparison with the expectations. The intention and emphasis of
this approach was to allow identification of all areas considered
relevant by the participant rather than to follow the PGI structure
verbatim. The issues raised by the participants were recorded ‘as
stated’ and later framed into individual questions under domains
identified by review of literature.1,15,16
Pre-existing quality of life questionnaires including WHO-
BREF, 1 SF-36 (Short Form- 36 questionnaire), 15 DQLCTQ
(Diabetes Quality of Life Clinical Trial Questionnaire), 16
ADDQoL (Audit of Diabetes Dependent Quality of Life),17 and
DQOL (Diabetes Quality of Life)18 were extensively reviewed.
Individual items identified by the three parallel approaches
namely expert opinion, patient interview and review of existing
literature were then formulated into specific questions and
screened for duplicate items. All items were rated on Likert
scale from 1 to 5 where ‘1’ indicated poorest quality of life for
choices like ‘always’ in case of questions like ‘How often do you
feel exhausted or tired by your health problems’ or for ‘very
dissatisfied’ in case of questions like ‘How satisfied are you
with the amount of time it takes to manage your diabetes’. The
highest rating of ‘5’ denoted the best quality of life standing for
‘never’ or ‘very satisfied’ in case of above two questions. The
questionnaire was framed with the intention of reflecting health
related quality of life (HRQOL) and the diabetes specific quality
of life (DSQOL). All items were apriori hypothesized to fit into
8 domains namely on the basis of review of existing literature
296 © JAPI • may 2010 • VOL. 58
   
   

 
   
     
   
   
 
     
    
    
     
  
   
     
   
   
   

’ 
  
 

and issue specified as relevant in patient interviews. A draft
questionnaire was thus formulated with 75 items.
Pilot trial
The stage I draft questionnaire administered to a convenience
sample of 20 participants by 4 diabetes educators after a written
informed consent.
Expert panel review
The responses obtained from the pilot trial were then
reviewed by an expert panel consisting of 4 clinicians and 4
diabetes educators for obvious irrelevance to >25% of patients
screened or refusal to answer. All questions were reviewed for
language and wording to provide clarity of meaning and avoid
duplication of the issue addressed. This led to the deletion of
21 items and modification in wording for several others leading
to the development of the Stage II questionnaire comprising 54
items.
Item analysis
The stage II draft questionnaire was then administered to a
sample of 150 type 2 diabetes patients (Study 1; sample size large
enough to satisfy the psychometric criteria of >5 participants per
final number of items anticipated)19 after an informed written
consent. participants with type 2 diabetes diagnosed more
than one year ago and between the ages of 35 to 65 years were
included in the study participants with any other chronic illness
which required the patient to be admitted in the hospital for
more than two weeks in the past one year, gestational diabetes
mellitus or inability to communicate due to physical or mental
disability were excluded from the study. Selected participants
were administered the stage II questionnaire by one of four
diabetes educators. The questionnaire administration by the
diabetes educators was pre standardized on the basis of video
recordings of 5 patients per educator to ensure uniformity in
administration and patient comprehension. In addition to the
question some baseline information including age, education,
employment status, family type and treatment for diabetes was
also recorded.
Data reduction (Principal Components Analysis)
Data from Study 1 was entered into SPSS version 13.0 for
statistical analysis. Factor analysis using the principal component
method by varimax rotation was used for data reduction with
the following pre-specified cut-offs and assumption based on
existing standard practices and norms: inclusion- extraction
communality >0.4; missing values for items <20%,1 values
for item with <20% missing to be replaced by mean (mean
imputation method); items with item – total correlation
coefficient >0.3; inter – item correlation <0.7; factor loading with
eigen value >1.20 The component identification was targeted to
explain 30-50% of the overall variance and subject to screening
by the scree plot and limited to a maximum of 8 domains on the
basis of the apriori hypothesis. The components identified on
the basis of clustering of factor loadings and the above cut-offs
were then named and the questionnaire restructured to compose
the “Stage III questionnaire”.
Reliability analysis
The stage III questionnaire was then tested for reliability
analysis using the alpha model after pre-specifying an overall
minimum cutoff value of Cronbach’s alpha as 0.8 and a subscale
cut-off of 0.5.
Concordant validity:
To establish concordant validity we co-administered the
 Table 1: Baseline characteristics of the study population participants presenting for preventive health check or from
among relatives of known diabetes patients. participants with
Overall Male Female
Characteristics
(n=150) (n=90) (n=60)
P value any chronic disease which required the patient to be admitted
in the hospital for more than two weeks in the past one year or
Age*(completed yrs) 53.5(7.4) 53.1(8.1) 54.2(6.3) 0.404
require medicines almost daily for the same for more than one
Age distribution (%)
month, any evidence of chronic hepatic/renal/pulmonary or
35-44 11.3 14.4 6.7
cardiac illness (verified by history/medical records), pregnancy
45-54 36.7 33.3 41.7 and inability to communicate due to physical/mental disability
55-65 52.0 52.2 51.7 were considered excluded from participation as cases or controls.
Duration since diagnosis* Questions for this study were suitably reframed for non-diabetic
10.5(6.4) 10.9(6.7) 10.0(5.8) 0.396
(years) individuals to reflect there health-related quality of life even
Employment status (%) for diabetes specific domains. Further analysis was conducted
Never worked 28 1.1 68.3 on the overall data available (n=210) subjects to determine the
Full time 55.3 84.4 11.7 responsiveness of the questionnaire to metabolic control, use
<0.001
Part time 6.7 5.6 8.3 of insulin, presence of co-morbidities and gender. Data was
Retired 10.0 8.9 11.7 analysed using independent samples ‘t’ test.
Total monthly income in rupees (%) Statistical Analysis
3,525-5,874 0.7 - 1.7 All analysis was performed using the SPSS v 13.0 software.
11,750-22,499 8.0 5.6 11.7 The factor analysis, reliability analysis, independent samples
23,000-49,999 20.0 20.0 20.0 0.396 ‘t’ test and the correlation analysis options were used where
>50,000 70.7 73.3 66.7 necessary.
Refused to comment 0.7 1.1 -
Highest educational qualification (%) Results
≤ High school 16.0 11.1 23.3 A total of 761 consecutive patients with type 2 diabetes visiting
Graduate / post- a specialty diabetes center at Delhi between April 2007 and July
66.7 62.2 73.3 0.003
graduate 2007 were screened for eligibility for Study 1. Four hundred and
Professional 17.3 26.7 3.3 seventy six participants fulfilled the selection criteria, 340 refused
HbA1c* (%) 8.6(1.8) 8.5(1.6) 8.8(2.0) 0.391 consent while 16 could not be included as they had participated
Systolic BP* (mmHg) 136.4(18.5) 137.3(17.3) 135.0(20.2) 0.299 in the earlier pilot trial (hence 150 participants were recruited
Diastolic BP* (mmHg) 82.3(10.0) 84.6(10.5) 79.0(8.2) 0.001 for administration of Stage II questionnaire). The participants
Co morbidities (%) recruited were comparable to those who refused consent for age,
CAD 12.7 17.8 5.0 0.021 gender, socioeconomic status, duration of disease and education
Nephropathy 24.7 25.6 23.3 0.759 (data not presented).The commonly cited reasons for refusal of
Retinopathy 16.7 15.6 18.3 0.657 consent were lack of time (n=214) and the questionnaire being
too long (n=106).
Neuropathy 24.7 25.6 23.3 0.759
Dyslipidemia 86.7 87.8 85.0 0.627 The baseline characteristics of the recruited participants
Hypertension 82.0 87.8 73.3 0.024 are presented in Table 1. As depicted the mean age of the
None 2.0 1.0 3.3 0.341
participants was 53.5 years and mean duration since diagnosis
of diabetes was 10 years. 84% of the participants had college
Current diabetes treatment (%)
education or higher and 70% had a monthly family income of
Oral Hypoglycemic
48.7 50.0 46.7 >Rs 50,000. Forty-seven percent were on insulin with or without
Agent only
oral hypoglycemics. The mean time taken for administration
Insulin only 8.7 8.9 8.3
of the Stage II questionnaire was 20.5 ± 3.6 min. Significant
Oral Hypoglycemic 0.568
38.7 35.6 43.3 differences were noted along expected lines between men and
Agent + Insulin
women in education, employment, coronary artery disease and
Lifestyle modification
4.0 5.6 1.7 hypertension.
only
Based on the results of the analysis of the data from 150
*Values are mean (SD).
participants, two items (physical pain associated with diabetes
study questionnaire and a preexisting validated diabetes and worry regarding having children) with >20% missing values
specific measure of quality of life (DQLCTQ) to 30 consentive had to be excluded (Table 2b). Four items which had item total
participants with type 2 diabetes (study 2 with the same selection correlation coefficient of <0.3 were excluded while two items
criteria). The product moment correlation (validity coefficient) were excluded as they were showing an inter-item correlation
was then calculated for the two scores after pre specifying an of >0.7. The solution presented (Table 2a) represents a solution
overall minimum cut-off value of 0.50 and a subscale to subscale using principal components forced to 8 components domains.
correlation of 0.4. As presented 34 items were identified across eight principal
Discriminant validity components (Table 2a). These components accounted for 49.9% of
Discriminant validity was established by administering the total item variance collectively while individual components
the stage III questionnaire to 30 participants with type 2 accounted for 3.1 to 20.3% of the total variance. The results show
diabetes and 30 non-diabetic apparently healthy, age, gender clean separation of the components. Twelve items failed to load
and socioeconomic status matched consenting controls (study into any of the selected principal components (Table 2b).
3). Diabetes patients were selected in accordance with the As depicted, component I had 6 items related to role
same criteria as study 1 while controls were selected from limitations (social life, work, travelling) due to physical health

© JAPI • may 2010 • VOL. 58 297

 Table 2a : Data reduction: Factor analysis using principal component method
Extraction Mean Missing Variance Item-total
1 2 3 4 5 6 7 8
communality (SD) n (%) explained correlation
1. Role limitation due to physical health (Social life, work, travelling)
20.3
How often miss the work because of diabetes/health
4.5
0.601 0.548 0.160 0.421 0.002 0.290 0.069 0.034 0.094 3(2.0) 0.580
(0.8)
How often does the requirement of regular medication and meals affect your work
4.5
0.591 0.644 0.135 -0.065 0.319 0.054 0.109 -0.012 -0.194 8(5.3) 0.509
(0.8)
How often does diabetes/health affect your efficiency at work
4.2
0.682 0.528 0.024 0.409 0.236 0.199 0.344 0.051 -0.140 2(1.3) 0.651
(1.0)
How often do you feel that diabetes/health is limiting your social life
0.566 0.554 0.225 -0.101 0.072 0.163 -0.043 0.359 0.189 4.1(0.9) 2(1.3) 0.466
To what extent do you avoid travelling(business tours, holiday, general tours) because of your diabetes/health
4.2
0.626 0.706 0.081 0.201 0.001 0.092 0.094 0.111 0.227 2(1.3) 0.488
(1.2)
Limitations of social activities (partying/visiting friends) as compared with others of your age because of your diabetes
4.3
0.629 0.719 0.137 0.033 0.033 -0.001 0.206 0.075 0.164 3(2.0) 0.528
(1.1)
2. Physical endurance 5.9
How often in the last 3 months your health problems limited vigorous activities you can do
0.584 0.326 0.572 0.157 0.045 0.059 0.048 0.216 -0.268 3.6(1.5) 25 (16.6) 0.564
How often in the last 3 months your health problems limited moderate activities you can do
4.4
0.574 0.116 0.621 0.298 -0.092 0.081 -0.011 0.254 -0.084 5 (3.3) 0.513
(1.1)
How often in the last 3 months your health problems limited your walking uphill/climbing1-2 floors
4.1
0.601 0.229 0.691 0.071 -0.040 0.211 0.123 0.030 0.064 1(0.6) 0.589
(1.3)
How often in the last 3 months your health problems limited you from walking 1-2 km at a stretch you can do
4.3
0.560 0.397 0.521 0.232 -0.064 0.180 0.158 0.125 0.003 7(4.6) 0.621
(1.2)
How often in the last 3 months your health problems limited you from bending, squatting or turning
0.655 -0.044 0.673 0.282 0.144 0.065 0.285 -0.018 0.120 4.2(1.2) 1(0.6) 0.623
How often in the last 3 months your health problems limited you from eating, dressing, bathing or using the toilet
0.627 -0.066 0.716 0.151 -0.094 0.094 0.016 0.037 0.258 4.8(0.7) 0(0) 0.472
3. General Health 5.4
In general you say your health is
0.430 0.006 0.066 0.511 0.240 0.118 0.034 0.250 0.172 2.7(0.8) 0(0) 0.400
How well are you able to concentrate on everything like reading, working, driving etc
3.7
0.429 0.229 0.092 0.468 0.083 0.061 0.137 0.206 -0.279 2(1.3) 0.382
(0.9)
How many times in the past 3 months have you felt fatigued or tired
0.663 0.104 0.283 0.661 0.244 0.193 0.063 0.029 0.182 3.7(1.1) 0(0) 0.574
4. Treatment satisfaction 4.1
Satisfaction with current diabetes treatment
3.9
0.518 0.024 0.005 0.127 0.647 0.200 -0.106 0.157 0.180 1(0.6) 0.401
(1.2)
Satisfaction with amount of time it takes to manage diabetes
3.8
0.625 -0.141 -0.006 0.173 0.732 0.167 0.103 0.015 0.016 3(2.0) 0.335
(1.1)
Satisfaction with the amount of time spent getting check-ups (e.g. once in three months)
0.591 0.150 -0.003 -0.068 0.741 0.050 -0.023 -0.044 -0.097 3.7(1.3) 2(1.3) 0.319
Satisfaction with the time spent exercising
0.402 -0.191 0.006 0.325 0.402 0.163 0.234 0.129 -0.005 3.6(1.5) 4(2.7) 0.316
5. Symptom botherness 3.9
How many times in the past three months you felt excessive thirst/dry mouth
0.476 0.068 0.219 0.214 0.061 0.589 0.015 0.091 0.132 3.9(1.2) 0(0) 0.486
Contd...

298 © JAPI • may 2010 • VOL. 58

 Table 2a : Data reduction: Factor analysis using principal component method
Extraction Mean Missing Variance Item-total
1 2 3 4 5 6 7 8
communality (SD) n (%) explained correlation
How many times in the past three months you felt excessive hunger
0.387 0.138 0.073 0.184 0.283 0.444 -0.082 -0.194 0.085 3.9(1.0) 0(0) 0.326
How many times in the past three months you had frequent urination related to polydipsia or increased water intake
0.479 -0.006 0.060 0.145 0.020 0.670 0.011 0.023 -0.068 3.9(1.1) 0(0) 0.361
6. Financial Worries 3.8
What do you think about the cost involved in the management of diabetes
2.3
0.455 0.002 0.197 -0.012 0.001 0.003 0.644 -0.022 0.022 0(0) 0.360
(1.0)
To what extent has your priority of expenditure shifted towards diabetes management
0.663 -0.024 0.094 -0.028 0.033 0.057 0.805 0.012 -0.002 3.4(1.3) 3(2.0) 0.385
To what extent your family budget affected by expenses related to diabetes management
0.575 0.150 0.121 0.183 -0.046 0.104 0.701 0.020 0.001 4.1(1.1) 1(0.6) 0.441
To what extend you diabetes has limited your expenditure on other aspects of life (movies, outings, parties)
0.552 0.307 0.042 0.178 0.041 -0.097 0.617 0.130 0.125 4.6(0.9) 5(3.3) 0.459
7. Emotional/Mental Health 3.5
Satisfaction with your self
0.518 -0.056 0.212 0.002 0.347 0.063 0.091 0.530 0.237 4.2(0.9) 0(0) 0.369
Satisfaction with personal relationships (family, friends, relatives)
0.549 0.371 -0.068 0.071 0.127 0.059 -0.072 0.613 -0.027 4.3(0.9) 0(0) 0.344
Satisfaction with the emotional support you get from friends and family
0.382 0.073 0.136 0.138 0.036 0.145 -0.010 0.562 -0.040 4.5(0.8) 0(0) 0.339
How often are you discouraged by your health problems
0.617 0.202 0.276 -0.204 0.142 0.464 0.105 0.444 0.122 4.0(0.9) 0(0) 0.456
To what extent do you feel that you are able to lead your life in a purposeful manner
3.5
0.449 0.062 -0.162 0.362 -0.029 0.198 0.152 0.473 -0.040 0(0) 0.439
(0.9)
8. Diet advise tolerance 3.1
How often feel restrictions in choosing food when eating out
3.2
0.519 0.216 0.046 -0.055 0.065 0.014 0.016 -0.054 0.678 8(5.3) .357
(1.4)
How much choice you have in eating your meals/snacks away from home
0.423 0.109 0.101 0.051 -0.028 0.100 0.106 0.087 0.607 3.2(1.1) 4(2.7) .372
How often you avoid eating out because of diabetes
0.530 0.298 -0.080 0.272 -0.116 -0.146 0.124 0.069 0.362 3.7(1.2) 8(5.3) .368
Total variance explained 49.9
and hence designated role limitation due to physical health. the scale had excellent overall reliability (Cronbach’s alpha 0.894)
Component II had 6 items which included physical activities and good subscale reliability (0.55 to 0.85).
and hence designated as physical endurance. Component III had 3 The selection of these 8 components was verified by the
items related to general health. Component IV had 4 items related examination of scree plot [21] (Fig. 2).The inter-item correlations
to treatment satisfaction. Component V had 3 items related to ranged from 0.015 to 0.521 and the item mean scores ranged
symptom frequency. Component VI had 4 items involved with from 3.099 to 4.780.
finances and hence designated as financial worries. Component
30 new participants were recruited for study 2 (of 44 eligible)
VII had 5 items related to emotional or mental health issues
at the same center in August 2007. The baseline characteristics
and hence designated as emotional/mental health. Component
of these participants were similar to those reported for Study 1
VIII had 3 items related to diet advice tolerance and hence
(data not presented). The product moment correlation (validity
designated as diet satisfaction factor. The domains and items
coefficient) between the scores obtained by DQLCTQ and
relating to general health role limitation due to physical health
the study questionnaire was 0.724 (p=0.001) establishing the
and ‘physical endurance’ could be classified as HRQOL while all
concordant validity. The subscale correlations between the two
other items/domains reflected DSQOL. A score for each domain
scales were primarily along expected lines (Table 4) further
was calculated by simple addition of items scores after mean
strengthening the concordance.
imputation for ‘not applicable’ values and screening for non-
additivity by Tukey’s test. Each individual domain score was then Thirty new cases and thirty age, gender and socioeconomic
standardized by dividing by maximum possible domain score status matched apparently healthy controls were recruited
and multiplying by 100. All individual standardized domain for study 3 at the same center in September and October 2007
scores were then added and divided by 8 (number of domain) to (eligible n=41). The baseline characteristics of these participants
obtain an overall score after screening for non-additivity (Tukey were comparable to those presented earlier (data not presented).
test p-value=0.097). The actual and standardized score with The difference in standardized total scores by QOLID between
subscale characteristics are summarized in Table 3. As depicted diabetes patients and apparently healthy controls was

© JAPI • may 2010 • VOL. 58 299

 Table 2b : Items deleted from the final questionnaire
Extraction Component Component Component Component Component Component Component Component Reason for
Items
communality 1 2 3 4 5 6 7 8 exclusion
Compared to three months ago rate your health now
0.281 0.171 0.116 0.193 0.414 0.047 0.087 0.029 -0.140 DNPC
How much do you enjoy leisure activities (watching TV, listening to music)
Item total
0.421 0.200 0.049 0.428 -0.208 -0.005 0.101 0.369 -0.076 correlation
<0.3
How well you accept your body look
0.336 0.196 0.044 0.202 0.185 0.323 0.208 0.268 0.034 DNPC
How often have you felt discouraged by your health problems
0.617 0.202 0.276 -0.204 0.142 0.464 0.105 0.444 0.122 DNPC
How often are you afraid about your health
0.523 0.169 -0.029 0.048 0.131 0.576 0.224 0.276 0.123 DNPC
How often are you frustrated about your health
0.555 0.046 0.178 0.098 0.195 0.480 0.196 0.358 0.276 DNPC
How often do you feel tired or weighed down by your health problems
Inter item
0.502 -0.006 0.285 0.402 0.337 0.231 0.184 0.123 0.208 correlation
> 0.7
How often you have enough energy to do the things you wanted to
0.357 0.286 0.166 0.388 0.257 -0.048 0.123 0.051 0.107 DNPC
Satisfaction with time it takes to determine sugar levels by glucometer
Item total
0.280 0.114 -0.176 0.031 0.447 0.031 -0.113 0.064 0.132 correlation
<0.3
How many times in the past three months you had blurred vision not corrected by wearing glasses
Item total
0.223 0.150 0.323 -0.083 -0.014 0.167 0.202 -0.072 0.121 correlation
<0.3
How many times in the past three months you had nausea/vomiting
0.319 0.151 0.224 0.482 0.007 0.061 -0.051 -0.039 -0.079 DNPC
How many times in the past three months you had pins/needle sensations of feet and hands
0.462 0.059 0.526 -0.021 0.353 -0.184 0.115 -0.010 -0.096 DNPC
How often do you eat the food items you should not in order to hide the fact that you do not have diabetes
0.317 0.301 0.028 0.125 0.288 -0.147 -0.072 0.145 0.282 DNPC
To what extent do you accept the restrictions that have been advised as far as the quantity of food items is concerned
Item total
0.355 0.072 0.098 0.037 0.165 0.474 -0.182 0.123 -0.198 correlation
<0.3
Satisfaction with your performance at work
0.547 0.366 0.098 0.456 0.085 0.338 0.117 0.226 0.102 DNPC
How often feel overloaded with work as compared to before diagnosis of diabetes
0.509 0.315 0.041 0.383 0.218 0.169 -0.129 -0.048 0.408 DNPC
To what extent has your travelling got affected because of your diabetes
Inter item
0.621 0.671 0.138 0.281 0.072 -0.110 0.020 0.116 0.207 correlation
>0.7
How often does your diabetes interfere with your relationship with family members
0.502 0.169 0.323 -0.134 0.434 0.068 0.161 0.316 0.177 DNPC
How often do you feel physical pain associated with the treatment for your diabetes
Not Not Not Not Not Not Not Not Not Missing
calculated calculated calculated calculated calculated calculated calculated calculated calculated value>20%
How often do you worry whether you will have children
Not Not Not Not Not Not Not Not Not Missing
calculated calculated calculated calculated calculated calculated calculated calculated calculated value >20%
DNPC-Did not load on any principal component

300 © JAPI • may 2010 • VOL. 58

 Table 3 : Subscale Characteristics
Actual Overall-subscale and inter-subscale correlations
Max Standardized
Cronbach’s Score Missing n
Subscale possible Score (Mean
alpha (Mean ± (%) 1 2 3 4 5 6 7 8
Score ± SD)
SD)
1 Social life, work
0.820 25.8±4.4 30 85.9 ± 14.6 14 (9.3) 1 .544 .524 .295 .365 .298 .496 .443
and travel
2 Physical endurance 0.849 25.3±5.5 30 84.3±18.4 31 (20.7) .544 1 .500 .249 .365 .318 .447 .212
3 General health 0.601 10.1±2.2 15 67.0±14.3 2 (1.3) .524 .500 1 .386 .363 .221 .371 .168
4 Treatment
0.705 19.3±4.1 25 77.3±16.5 7 (4.6) .295 .249 .386 1 .294 .160 .382 .065
satisfaction
5 Symptom
0.616 11.7±2.4 15 78.2±16.2 0 (0) .365 .365 .363 .294 1 .120 .286 .099
frequency
6 Financial worries 0.740 14.4±3.2 20 72.1±16.0 6 (4.0) .298 .318 .221 .160 .120 1 .208 .238
7 Emotional / mental
0.614 20.8±2.9 25 83.1±11.5 1 (0.7) .496 .447 .371 .382 .286 .208 1 .193
health
8 Diet advise
0.554 10.1±2.8 15 67.1±18.3 17 (11.3) .443 .212 .168 .065 .099 .238 .193 1
tolerance
Overall 0.894 - 175 77.3 ±9.5 52 (34.6) .779 .808 .670 .583 .541 .533 .662 .415
Scree Plot statistically significant (calculate P) suggesting discriminant
12 validity (Table 5). The overall data available was then analysed
to evaluate the responsiveness of the standard overall score,
10 glycemic control, insulin use, presence of co-morbidities and
gender. The mean time taken for administration of the Stage III
8 questionnaire was 7.8±2.8 min.
Eigenvalue

6 Discussion
The questionnaire developed and validated consists of
4
34 items covering eight domains which comprehensively
covers aspects of quality of life namely role limitations due
2
physical health, physical endurance, general health, treatment
satisfaction, symptom frequency, financial worries, mental
0
health, and diet advice satisfaction. All these domains and items
had high internal consistency (Cronbach’s alpha of 0.894). The
1 2 3 4 5 6 7 8 9 1 1 1 1 1 1 1 1 1 1 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 5 5 5
0 1 2 3 4 5 6 7 8 9 0 1 2 3 4 5 6 7 8 9 0 1 2 3 4 5 6 7 8 9 0 1 2 3 4 5 6 7 8 9 0 1 2

Component Number
high refusal rates with the Stage II questionnaire decreased to
Fig. 2 : Factor analysis: Scree plot of the Eigen values of extracted
components acceptable levels (~ 16%) with final questionnaire and the time
Table 4: Concomitant validity: Correlation of QOLID subscales with DQLCTQ domains
Cent_
Total GH_ CH_ PF_ GRF_ GFD_ SF_ EF_ HD_ MH_ Sat_ Imp_ SW_ DW_ TS_ TF_ SS_
SF_
Score D1 D2 D3 D4 D5 D6 D7 D8 D9 D10 D11 D12 D13 D14 D15 D16
D17
1. Role limitation
due to physical
health (Social .434* -.196 -.095 .144 .029 .219 .486** .352 .351 .054 .335 .572** -.157 .299 .079 .368* -.087 -.073
life, work,
travelling)
2. Physical
.491** .033 -.284 .211 -.088 .117 -.127 .530** .512** .320 .341 .438* -.169 .062 .233 .058 .145 .484**
endurance
3. General health .213 -.182 -.012 .449* -.238 .204 .561** .261 .046 -.257 -.156 .035 -.197 .166 -.100 .483** -.097 .242
4. Treatment
.504** .199 -.218 .384* -.041 .122 -.011 .075 .053 .284 .779** .462* -.254 .363* .409* .272 -.109 -.014
satisfaction
5. Symptom
.270 .193 -.316 .009 .024 -.114 -.267 .165 .371* .217 .097 .184 -.024 .019 .297 -.244 .130 .646**
botherness
6. Financial
.251 .098 .052 -.162 .258 -.154 -.099 .097 .166 -.137 .034 .523 -.189 .346 .146 .299 -.154 .193
worries
7. Emotional/
.287 -.358 -.019 .167 -.225 -.038 .167 .608** .434* .609** .429* .312 -.023 .279 -.134 .256 .282 .012
mental health
8. Diet advise
.034 -.346 .207 -.033 .016 .040 .072 .080 .072 -.260 -.208 .011 -.102 .134 -.039 .457* -.254 .103
tolerance
Total Score .557 **
-.129 -.206 .320 -.125 .121 .180 .500 **
.457*
.286 .414
*
.479 **
-.228 .305 .205 .363 *
.025 .405*
GH_D1- General Health; CH_D2- Comparative health; PF_D3- Physical functioning; GRF_D4- Global role functioning; GFD_D5- Global functioning
difficulty; SF_D6- Social functioning; EF_D7- Energy fatigue; HD_D8- Health distress; MH_D9- Mental health; Sat_D10- Satisfaction; Imp_D11-
Impact; SW_D12- Social worry; DW_D13- Diabetes worry; TS_D14 - Treatment satisfaction; TF_D15- Treatment flexibility; SS_D16- Social stigma;
Cent_SF_D17- Frequency of Symptoms.

© JAPI • may 2010 • VOL. 58 301

 Table 5 : Discriminant validity¶ (n=210)
HbA1c Insulin use Multiple co-morbidities Gender
Subscale
≤8 >8 Insulin Others ≤1 >1 Males Females
1 Social life, work and travel 88.9 82.7 83.1 88.1 81.7 89.5 87.1 84.0
2 Physical endurance 87.1 81.8 81.6 86.1 77.9 88.6 89.4 76.4
3 General health 71.2 64.1 65.1 68.7 65.7 68.0 68.5 64.7
4 Treatment satisfaction 82.0 74.4 77.2 77.5 75.7 78.6 77.8 76.6
5 Symptom botherness 81.9 75.1 78.0 78.5 77.7 78.6 78.4 78.0
6 Financial worries 72.4 71.6 69.7 74.1 70.3 73.6 74.1 68.9
7 Emotional / mental health 84.2 82.2 81.1 84.8 80.0 85.6 84.5 80.7
8 Diet advise tolerance 67.8 65.5 67.1 67.1 65.1 68.8 67.9 65.7
Overall 79.5 75.5 77.0 77.5 75.2 78.9 79.3 73.9
p value < 0.05 (significant difference) is bolded; ¶All values depicted are mean standardized scores; πBMI- Body mass index; γDuration- Duration
of diabetes in years since diagnosis; δInsulin – Insulin use with or without oral anti Diabetic agents; βNo of comorbidities- This includes coronary
artery diseases, retinopathy, neuropathy, nephropathy, hypertension and dyslipidemia.

taken for administration decreased from 20.5±3.6 min to 7.8±2.4
min. The questionnaire represents a quality of life tool covering
HRQOL and DSQOL developed and validated in India using
standard methodology. The psychometric measures for the
questionnaire variability explained, factor loadings, item total
correlations, concordant and discriminant validity are within
desirable range and above suggested cutoff.7 The psychometric
strength of the questionnaire is further enhanced by the use of
a standard Likert scale across all questions. The study is limited
by the high refusal rates of approximately 70% at the step 2 of
questionnaire development (Study 1). This may have led to
selection bias i.e. highly motivated participants who filled the
questionnaire. However, the refusal rate final questionnaire
(Study 2 and 3) was 16% which may reflect that the participants
are more comfortable with shorter version of questionnaire.
Secondly, the study population was selected from specialized
clinic and may not represent the community response. Inspite
of these limitations this instrument is the first reliable, validated
and sensitive tool for comprehensive health related and diabetes
specific the assessment of quality of life in patients with type
2 diabetes in India. It takes only 7.8(SD 2.4) minutes for this
questionnaire and hence it can be used during routine physician
consultation. This can be applied in practice based care as an
outcome measure in assessing the impact on quality of life for
more or less intense treatment options. A systematic review7
published recently critically evaluated 16 scales assessing
HRQOL in diabetes patients namely ADS (Appraisal of diabetes
scale), ADDQoL,17 D-39 (diabetes-39), DCP (diabetes care profile),
DDS (diabetes distress scale), DHP (diabetes health profile),
DIMS (diabetes impact measurement scales), DQLCTQ-R
(diabetes quality of life clinical trial questionnaire-revised;
16), DQOL,18 DSQOLS (diabetes specific quality of life scale),
EDBS (elderly diabetes burden scale), IDSRQ (insulin delivery
system rating questionnaire), LQD (quality of life with diabetes
questionnaire), PAID (problem area in diabetes scale), QSD-R
(questionnaire on stress in patients with diabetes-revised),
WED (well-being enquiry for diabetics). The overall Cronbach’s
alpha of the scales assessing HRQOL in 0.77 to 0.91 (0.894 in our
study) while the subscale range was 0.54-0.97 (0.55-0.85 in our
study). The item total correlations were not reported for most
of the scales reviewed (10 of 16). Among the six scales reporting
the item total correlations it ranged from 0.28-0.84 which was
comparable to our study (0.316 to 0.651). The percentage variance
planned by factor analysis for the scales evaluated ranged from
39-69.4% while the number of factors loaded in the solutions
presented ranged from 1 to 8 (in our study 49.9% of the variance
was explained using an 8 factor solution). Responsiveness across
the sixteen instruments for the diabetes population studied
were evaluated only by author of the DQLCTQ-R and PAID.
On DQLCTQ-R four domains (Treatment Satisfaction, Health
Distress, Mental Health, and Satisfaction) were responsive to
change in metabolic control (comparable to the change in 4
domains of our scale-role limitation due to physical health,
general health, physical endurance and symptoms frequency).
The domains documented in our study are similar to those
reported for the evaluated scales excepting ‘financial worries’
and ‘diet advice satisfaction’. The ‘financial worries’ domain
may be a reflection of the health system in India (poor insurance
coverage) and the mindset of our people while the dietary advice
satisfaction domain may be related to the poor acceptability in
India for dietary and lifestyle modifications.
In summary QOLID is a reliable, valid and sensitive tool
for the assessment of diabetes specific quality of life in Indian
subjects. Further work is necessary to validate the instrument
across a wider socio-economic spectrum and in community
settings. Linguistic validation is also necessary to allow the
administration in different languages to a larger proportion of
patients.
Acknowledgments
The authors acknowledge the invaluable inputs provided
by Dr A. S. Lata, Senior Diabetologist, Sitram Bhartia Institute
of Science and Research (SBISR) and Dr H.P.S. Sachdev, Senior
Consultant, Pediatrics and Clinical Epidemiology, SBISR.
We also acknowledge the efforts of Ms Parul Malhotra and
other educators at the SBISR. The study was conducted using
intramural funding from Sitaram Bhartia Institute of Science
and Research.
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Always Frequently Often Sometimes Never
people with diabetes mellitus: the ADDQoL-Teen. Health Qual Life
Outcomes. 2004; 2:61-74 1 2 3 4 5
2. A person with diabetes has the requirement of adhering to a
6. Rao P.R, Shobhana R, Lavanya A, Padma C, Vijay V, Ramachandran schedule for eating and taking regular medication. How often does
A. Development of a reliable and valid psychosocial measure of this affect your work?
self perception of health in type 2 diabetes. JAPI. 2005; 53:689-692
Always Frequently Often Sometimes Never
7. El Achhab Y, Nejjari C, Chikri M, Lyoussi B. Disease-specific 1 2 3 4 5
health-related quality of life instruments among adults diabetic: A 3. How often does diabetes affect your efficiency at work?
systematic review. Diabetes Res Clin Pract. 2008;80:171-184.
Always Frequently Often Sometimes Never
8. Bott U, Jörgens V, Grüsser M, Bender R, Mühlhauser I., Berger 1 2 3 4 5
M. Predictors of glycaemic control in type I diabetic patients after 4. How often do you find diabetes limiting your social life?
participation in an intensified treatment and teaching programme.
Diabet Med. 1994;11:362–371 Always Frequently Often Sometimes Never
1 2 3 4 5
9. Dunn S.M. Reactions to educational techniques: coping strategies 5. To what extent do you avoid traveling (business tour, holiday,
for diabetes and learning. Diabet Med. 1986; 3: 419–429. general outings) because of your diabetes?
10. Weinberger M, Kirkman M.S, Samsa G.P, Cowper P.A, Shortliffe A lot Highly Little Very little Not at all
E.A, Simel D.L. et al. The relationship between glycemic control and 1 2 3 4 5
health-related quality of life in patients with non-insulin-dependent 6. Compared to others of your age are your social activities (visiting
diabetes mellitus. Med Care. 1994;32: 1173–1181 friends/partying) limited because of your diabetes?
11. The Diabetes Control and Complications Trial Research Group. Always Frequently Often Sometimes Never
Influence of intensive diabetes treatment on quality-of-life outcomes 1 2 3 4 5
in the Diabetes Control and Complications Trial. Diabetes Care. Physical Endurance
1996;19: 195–203 An important part of understanding your general health and well
12. Bardsley M.J, Astell S, McCallum A, Home P.D. The performance of being has to do with your ability to perform various activities.
three measures of health status in an outpatient diabetes population. Thus for the following questions please indicate if your health has
Diabet Med. 1993;10: 619–626 limited your activities in following areas in the past three months. Please
13. Glasgow R.E, Osteen V.L. Evaluating diabetes education: are tick any one option.
we measuring the most important outcomes? Diabetes care. 1. How often in last three months has your overall health problems
1992;15:1423-1432 limited the kind of vigorous activities you can do like lifting heavy
bags/objects, running, skipping, jumping.
14. Ruta D.A, Garratt A.M, Leng M., Russell I.T, MacDonald L.M. A
new approach to the measurement of QoL- Patient Generated index. Always Frequently Often Sometimes Never
Medical Care. 1994;11(S-8):1109-1126 1 2 3 4 5
2. How often in last three months has your overall health problems
15. Ware J.E. SF-36 Health Survey. Manual and Interpretation Guide.
limited the kind of moderate activities you can do like moving a
Boston: The Health Institute. 1993
table, carrying groceries or utensils.
16. Shen W, Kotsanos J.G, Huster W.J, Mathias S.D, Andrejasich C.M,
Patrick D.L. Development and validation of the Diabetes Quality of Always Frequently Often Sometimes Never
Life Clinical Trial Questionnaire. Medical Care. 1999;37,AS45-AS66 1 2 3 4 5
3. How often in last three months has your overall health problems
17. Bradley C, Todd C, Gorton T, Symonds E, Martin A, Plowright R. limited you from walking uphill or climbing 1-2 floors.
The development of an individualized questionnaire measure of
perceived impact of diabetes on quality of life: The ADDQoL. Qual Always Frequently Often Sometimes Never
Life Res. 1999;8: 79-91 1 2 3 4 5
4. How often in last three months has your overall health problems
18. DCCT Research Group. Reliability and validity of a diabetes quality limited you from walking 1-2 km at a stretch.
of life measure for the Diabetes Control and Compliance Trial
(DCCT). Diabetes care. 1988;11: 725-732 Always Frequently Often Sometimes Never
1 2 3 4 5
19. Karper Rao. Using Multivariate Statistics by Tabachnik BG,Fidell 5. How often in last three months has your overall health problems
LS. New York. 1983 limited you from bending, squatting, or turning.
20. Nunnally J.C, Berstein I.H. Psychometric theory. 3rd edition. New Always Frequently Often Sometimes Never
York: McGraw – Hill. 1994 1 2 3 4 5
21. Cattle R.B. The scree Test for the number of factors. Multivariate 6. How often in last three months has your overall health problems
behavioural res. 1966;1245-127. limited you from eating, dressing, bathing, or using the toilet.
Always Frequently Often Sometimes Never
Appendix 1 : 1 2 3 4 5
General Health
Final Qolid Questionnaire 1. In general would you say your health is.
Instruction Poor Fair Good Very good Excellent
The following assessment asks how you feel about the impact of 1 2 3 4 5
diabetes on your quality of life. Your response will help us find ways 2. How well are you able to concentrate in everything like working,
for improving diabetes care. If you are unsure about which response to driving, reading etc?
give to a question, please choose the one that appears to be the most Not at all A little Moderate Very much An extreme amount
appropriate. We would request you to attempt to answer all questions. 1 2 3 4 5

© JAPI • may 2010 • VOL. 58 303

3. How many times in the past three months have you had fatigue/ 3. To what extent has your family budget got affected by the expenses
felt very tired? related to the management of diabetes?
Always Frequently Often Sometimes Never A lot Highly Little Very little Not at all
1 2 3 4 5 1 2 3 4 5
Treatment Satisfaction 4. To what extent has your diabetes limited your expenditure on other
The following set of questions would enable us to know how satisfied aspects of life (Movies, outings, parties etc)?
are you with your treatment for diabetes. Please tick any one option. A lot Highly Little Very little Not at all
1. How satisfied are you with your current diabetes treatment? 1 2 3 4 5
Neither Emotional/Mental Health
Very Moderately Moderately Very
satisfied nor 1. How satisfied are you with yourself?
dissatisfied dissatisfied satisfied satisfied
dissatisfied Neither
1 2 3 4 5 Very Moderately Moderately Very
satisfied nor
2. How satisfied are you with amount of time it takes to manage your dissatisfied dissatisfied satisfied satisfied
dissatisfied
diabetes? 1 2 3 4 5
Neither 2. How satisfied are you with your personal relationships (family,
Very Moderately Moderately Very
satisfied nor friends, relatives and known tos)
dissatisfied dissatisfied satisfied satisfied
dissatisfied Neither
1 2 3 4 5 Very Moderately Moderately Very
satisfied nor
3. How satisfied are you with the amount of time you spend getting dissatisfied dissatisfied satisfied satisfied
dissatisfied
regular checkups (once in 3 months)? 1 2 3 4 5
Neither 3. How satisfied are you with the emotional support you get from
Very Moderately Moderately Very
satisfied nor your friends and family?
dissatisfied dissatisfied satisfied satisfied
dissatisfied Neither
1 2 3 4 5 Very Moderately Moderately Very
satisfied nor
4. A person with diabetes needs to exercise for 35-45 min, 4 times a dissatisfied dissatisfied satisfied satisfied
dissatisfied
week. Keeping this in mind how satisfied are you with the time 1 2 3 4 5
you spend exercising? 4. How often are you discouraged by your health problems?
Neither Always Frequently Often Sometimes Never
Very Moderately Moderately Very
satisfied nor 1 2 3 4 5
dissatisfied dissatisfied satisfied satisfied
dissatisfied 5. All people want to fulfill certain roles and lead their lives in a
1 2 3 4 5 purposeful manner. To what extent do you feel that you have been
Symptom Botherness able to lead your life in the same way?
1. How many times in the past three months have you had thirst/dry
mouth? Not at all A little Moderate Very much An extreme amount
1 2 3 4 5
Always Frequently Often Sometimes Never Diet Satisfaction
1 2 3 4 5 Diabetes demands a little modification in diet, thus the following
2. How many times in the past three months have you felt excessive set of questions would help us know how much satisfied you are with
hunger? modifications in your diet.
Always Frequently Often Sometimes Never (For participants who have been advised some dietary modification/
1 2 3 4 5 counseling).
3. How many times in the past three months have you had frequent 1. How often do you feel because of your diabetes a restriction in
urination related to diabetes management? choosing your food when eating out?
Always Frequently Often Sometimes Never Always Frequently Often Sometimes Never
1 2 3 4 5 1 2 3 4 5
Financial Worries 2. As you have diabetes, how much choice do you feel you have in
The following set of questions will help us know how your diabetes eating your meals or snacks away from home e.g. if you go in a
has affected your or your family’s finances. Please tick any one option…. party and there is a buffet where there are also a lot of fried snacks
1. What do you think about the cost involved in your management and desserts would you be able to make enough choice?
of diabetes? No choice Very little little enough A lot
Very expensive little expensive reasonable not at all expensive 1 2 3 4 5
1 2 3 4 3. How often do you eat the food items that you shouldn’t, in order
2. To what extent has your priority of expenditure shifted towards to hide the fact that you are having diabetes.
diabetes management? Always Frequently Often Sometimes Never
A lot Highly Little Very little Not at all 1 2 3 4 5
1 2 3 4 5

Office Bearers of API - Jharkhand Chapter Session 2010-2012

Chairman : Dr. Rajendra Kumar Jha • Secretary : Dr. Umesh Prasad • Treasurer : Dr. A.K. Verma

Dr. S.N. Sharma Dr. D.K. Jha

Ex-Chairman, API Jharkhand Chapter Ex-Secretary, API Jharkhand Chapter

304 © JAPI • may 2010 • VOL. 58