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ORIGINAL ARTICLE

Validation of the Asthma Quality of Life Questionnaire


(AQLQ–UK English Version) in Indian Asthmatic Subjects
Sunil K. Chhabra and Shivu Kaushik

Department of Cardiorespiratory Physiology, Clinical Research Centre, Vallabhbhai Patel Chest Institute,
University of Delhi, Delhi, India

ABSTRACT
Background. The Asthma Quality of Life Questionnaire (AQLQ) has been shown to have strong
measurement properties. Quality of life instruments need to be validated under local conditions
before these can be accepted for application in that community. The AQLQ has not been
formally validated in India.
Objectives. To measure the evaluative and discriminative properties of the AQLQ (UK English
version) in Indian asthmatics.
Methodology. Thirty-eight adult patients with asthma underwent spirometry and completed
the AQLQ and the Asthma Control Questionnaire (ACQ), administered by an interviewer.
Standard treatment was given for four weeks during which daytime and nocturnal symptoms
of asthma, and use of rescue medication were recorded in diaries. The questionnaires were
administered again at the end of four weeks and spirometry was repeated.
Results. The total and domain-wise scores of AQLQ improved in patients whose control of
asthma improved during treatment. It had good reproducibility with no changes in scores in
patients whose condition remained stable, and also high intraclass correlation coefficients for
the total and domain-wise scores in these patients. Significant correlations were found between
the changes in AQLQ scores and in ACQ scores confirming the longitudinal construct validity.
The symptoms domain score of the AQLQ was related significantly to the patient diary-
recorded scores of cough, sputum and nocturnal asthma. Cross-sectional construct validity of
AQLQ was established by demonstrating significant correlation of total, and symptoms and
emotions domain scores with the ACQ scores.
Conclusions. It was concluded that the AQLQ (UK English version) has sufficiently acceptable
evaluative and discriminatory properties in Indian subjects and is therefore a valid instrument
for quality of life measurements in clinical and research studies in asthmatics in Indian patients.

Key words: Asthma, Health-related quality of life, Asthma quality of life questionnaire, Asthma control
questionnaire.

[Indian J Chest Dis Allied Sci 2005; 47: 167-173]

INTRODUCTION and social spheres of a patient’s life. Effec-


tiveness of asthma treatment has traditionally
Asthma is a disease that can result in varying been assessed by measuring the change in
degrees of restriction in the physical, emotional clinical outcome parameters such as expiratory
[Received: January 21, 2004; accepted after revision: June 21, 2004]
Correspondence and reprints request: Dr S.K. Chhabra, Professor and Head, Department of Cardiorespiratory
Physiology, Clinical Research Centre, Vallabhbhai Patel Chest Institute, University of Delhi, Delhi-110 007, India;
Tele.: 91-11-27667102; Telefax: 91-11-27667420; E-mail: <skchhabra@mailcity.com>.
168 Asthma Quality of Life S.K. Chhabra and S. Kaushik

flow rates, symptoms and the need for other MATERIAL AND METHODS
medications. It has been assumed that if one or
more of these indices has improved, then the Subjects
patient’s health-related quality of life must have
Both male and female patients diagnosed to
improved. This may not be true. Conversely, a
have bronchial asthma, in the outpatient clinic
patient may feel and function better, but this
of the Clinical Research Center, Vallabhbhai
may not be captured by the conventional clinical
Patel Chest Institute, Delhi, were included in the
outcomes. Assessment of disease-specific
study. The diagnosis was established on the
quality of life in clinical trials has gained wide- basis of characteristic symptoms and
spread acceptance in the last decade because of demonstration of reversibility of airways
an increased awareness of its importance as an obstruction (post-bronchodilator increase of 200
independent outcome measure. This has been ml and 12% over baseline in FEV 1 ) as
further facilitated by the development of recommended in the Expert Panel Report9 of the
instruments with strong measurement National Institutes of Health, USA. Informed
properties for assessing quality of life1,2. consent was obtained from all the patients. The
Among the various instruments available, inclusion criteria was : age group 15-40 years, no
Juniper's Asthma Quality of Life Questionnaire other concurrent pulmonary or systemic
(AQLQ) has been tested extensively. Several disease; relatively stable clinical state but
independent studies have shown that it has currently symptomatic; ability to understand
and respond to the English language. Patients
strong measurement properties, both as an eva-
were excluded if they had a history of smoking
luative and as a discriminative instrument3-8. It
(>10 pack years), presence of previous lesions or
has been translated into various languages.
history of pulmonary tuberculosis or any other
Instruments to measure the asthma-specific respiratory disorder, any other chronic systemic
health-related quality of life (HRQoL) have not disease that may affect quality of life such as
been developed in India. Therefore, for any diabetes, hypertension, coronary artery disease,
study on quality of life in Indian patients with arthritis or were pregnant or lactating (for
asthma, the instruments available in other females), etc.
countries will have to be used. Quality of life is
likely influenced, besides by disease severity Study design
and its treatment, by environment, personal
socio-economic and cultural factors. These A detailed history was taken from all the
subjects. Baseline spirometry was carried out in
factors would vary from region to region and
all the subjects. Maximum expiratory flow
from country to country. Further, the language
volume curves were obtained on a dry rolling-
used in a quality of life instrument may have
seal spirometer (Benchmark Lung Function
different meanings in different populations.
machine-PK Morgan, UK) according to the
Therefore, an instrument must be validated American Thoracic Society recommendations
under local conditions before it can be accepted for spirometry 10. The highest FVC and FEV 1
for application in that population. In the absence were selected. Regression equations for lung
of any indigenous instrument to measure function for Indian adults were used to calculate
quality of life, there is a need to evaluate percent-predicted values11.
whether the available Asthma Quality of Life
The following assessments were carried out
Questionnaire (AQLQ) instrument is suitable
at the time of inclusion into the study:
for the Indian population. The present study
was carried out with this aim. The UK English (i) Control of asthma : The degree of control
version of AQLQ was used, as a Hindi was assessed using the Asthma Control
translation had not been developed at the time Questionnaire (ACQ) 12 . The questionnaire
when this study was carried out. includes questions pertaining to five symptoms
2005; Vol. 47 The Indian Journal of Chest Diseases & Allied Sciences 169

considered most important for assessing asthma Improvement in clinical state of asthma after
control. In addition there is a question on short- four weeks of treatment was defined as an
acting beta 2-agonist use and another on FEV1% increase in the ACQ score of 0.5 or more14. At the
predicted. Patients recalled their experiences end of four weeks, patients who showed an
during the previous seven days and responded improvement were assigned to Group A and
to each question using a seven-point scale. The those who showed no change in ACQ, to Group
items are equally weighted and the ACQ score is B. No patient showed a worsening.
the mean of the seven items and therefore
between 0 (well-control) and 6 (extremely Statistical analysis
poorly controlled).
Statistical analysis was carried out with the
(ii) Asthma quality of life questionnaire 3 help of SPSS 11.5 and Graphpad Prism 3.0 for
(interviewer-administered version): The AQLQ has windows. Continuous variables were compared
32 questions, the first five of which are patient- using unpaired/paired student’s t test.
specific activities. At the first visit each patient Validation of the AQLQ was done by
selects the five activities in which he or she has measurement of its evaluative (responsiveness
been troubled the most by asthma during the and longitudinal construct validity) and
previous two weeks. These activities are discriminative (reproducibility and cross-
retained throughout the study for subsequent sectional construct validity) properties16.
tests. Patients respond to each question on a
seven-point scale and recall their experiences
Evaluative properties
during the previous two weeks. Results are
expressed as scores for each of four domains (i) Responsiveness : This is the ability of the
(symptoms-12 questions, activities-11 questions, questionnaire to detect changes in clinical status
emotional function-5 questions and environ- even if these are small. The responsiveness of
mental exposure-4 questions) and as an overall the questionnaire was determined in two ways,
score. The total and the domain scores range firstly by comparing the scores between the
from 1 to 7 with higher scores indicating a better patients who improved (Group A) and those
quality of life. who remained stable (Group B) using the
After initial assessment and administration of unpaired ‘t’ test and, secondly, by the ability of
the study questionnaires, the patients were the questionnaire to detect statistically
prescribed appropriate treatment as per the significant changes in patients who improved
severity of asthma9. This consisted of inhaled (Group A) using the paired ‘t’ test.
corticosteroids (budesonide: 400-800 µg/day or (ii) Longitudinal construct validity: Longitu-
fluticasone propionate: 250-500 µg/day) and if dinal construct validity was evaluated by
required inhaled long-acting bronchodilators correlating within-subject changes in quality of
(salmeterol: 50-100 µg/day or formoterol: 12-24 life scores during the four weeks observation
µg/day). Inhaled salbutamol (200 µg per dose, period with within-subject changes in other
=2 puffs) was prescribed as rescue medication. indices of clinical asthma severity, i.e. ACQ
All drugs advised to patients were in the form scores, FEV1 and the diary scores.
of metered dose inhalers. The patients were
provided diaries to record daytime symptoms Discriminative properties
(cough, phlegm, breathlessness/wheezing),
nocturnal symptoms and use of rescue (i) Reliability: This is the ability of the
medication. The scores were graded from none instrument of give reproducible results when
(0) to mild (1), moderate (2) and severe (3). The the clinical state is stable. Reliability of the
patients were assessed again at the end of four instruments was determined from the data of
weeks when the AQLQ and ACQ question- patients who remained stable (Group B) between
naires were administered. Diary scores were baseline and four weeks. The scores were
noted. Spirometry was repeated. compared on the two occasions (paired ‘t’ test)
170 Asthma Quality of Life S.K. Chhabra and S. Kaushik

and changes not significant were taken as an Table 2 shows the changes in AQLQ scores in
indicator of reproducibility. Further reliability the two groups. Except for the environmental
analysis was carried out by calculating the domain scores, the total and other domain
intraclass correlation coefficient for total and scores were significantly different, being higher
domain scores. Intraclass correlation coefficient in Group A patients, indicating an improved
was calculated as a measure of agreement quality of life. All the scores showed a mean
within cases using the reliability analysis change greater than one, that represents a
module of SPSS 11.5 software. moderate change in the quality of life17.
(ii) Cross sectional validity: It is the ability of the
Table 2. Comparison of changes in AQLQ total and
questionnaire to determine whether between-
domain scores in the two groups of patients
patients differences in quality of life truly reflect
differences in their clinical state. Cross sectional ∆ AQLQ Group A Group B
validity was evaluated by correlating quality of ∆ Total Score 1.46 ± 0.89* 0.37 ± 0.98
life scores at baseline with other measures of ∆ Symptoms 1.82 ± 1.11** 0.00 ± 1.25
asthma severity i.e. ACQ scores and FEV 1% ∆ Activity 1.41 ± 1.10* 0.25 ± 0.46
predicted. ∆ Emotional 1.19 ± 1.03+ 0.28 ± 1.13
∆ Environment 1.31 ± 1.46ns 0.62 ± 1.51
∆: Change; *:p<0.05; **:p<0.01; +:p<0.02; ns:p>0.05.
RESULTS

Patient characteristics 7
AQLQ Domain Scores Mean ± SD

6 **
A total of 38 patients (21 males and 17 females) **
** **
were included in the study. Thirty subjects 5 **
completed the study. The reason for the eight
subjects dropping out from the study was not 4

known. Thus, data from 38 patients was used for 3


cross-sectional construct validity analysis while
that from 30 patients was used for analysis 2

where two sets of data were required. The chara- 1


cteristics of the patients are shown in table 1.
0
0 wk 4 wk
Table 1. Patient’s characteristics Total Symptoms Activity Environment Emotional

Patient characteristics Description Figure 1. AQLQ total and domain scores at 0 week
and at four weeks in Group A patients.
Age (yrs) Mean±SD 26.89±8.24
Sex (n) Figure 1 shows the AQLQ total and domain
Males/Females 21/17
scores at 0 wk and at 4 wk in Group A patients.
Severity of Asthma (n) The scores showed a significant increase
Mild persistent 8 indicating an improved quality of life. The mean
Moderate persistent 15
total score on the second visit was 5.73 ± 0.77
Severe persistent 15
compared to 4.27 ± 0.78 at 0 wk (p<0.0001).
Domain-wise, the scores at 0 and 4 wk were,
Evaluative properties respectively; symptoms: 4.16±0.70 and 5.99±
0.90, p<0.0001; activities: 4.23±1.01 and
Responsiveness
5.64±0.85, p<0.0001; emotional: 4.60±0.89 and
Twenty-one patients improved after 5.80±1.05; p<0.0001; environment: 4.20±1.53 and
treatment and were assigned to Group A. Nine 5.51±1.15, p<0.001. This improvement in quality
patients whose control status remained of life scores in Group A was associated with an
unchanged were assigned to Group B. improvement in lung function indices. The FEV1
2005; Vol. 47 The Indian Journal of Chest Diseases & Allied Sciences 171

improved to 2.97±0.78L on the 2nd visit 8

AQLQ Domain Scores Mean ± SD


compared to 2.18±0.46 on the 1st visit 7
ns ns
(p<0.0001). The FVC on the 2nd visit was ns
6 ns
3.99±0.83L that was significantly greater than ns
the baseline value of 3.56±0.63L (p<0.01). 5

4
Longitudinal construct validity 3

Longitudinal construct validity correlations 2


are shown in the table 3. There were significant 1
correlations between the changes in quality of 0
life scores and the ACQ scores. However, no Total
0wk
Symptoms Activity
4wk
Environment Emotional
significant correlations were found between the
changes in quality of life scores and other Figure 2. AQLQ total and domain scores at 0 week
indices of clinical asthma i.e. change in FEV1 and and at four weeks in Group B patients.
the FEV1% predicted. Significant correlations
wise, the scores at 0 and four weeks were,
were also found between the symptoms domain
respectively; symptoms: 5.25±1.21 and
of the AQLQ and the patient diary recorded
5.25±1.76, p>0.05; activities: 4.99±1.28 and
scores of cough, sputum and nocturnal asthma.
5.25±1.21, p>0.05; emotional: 5.04±1.17 and
No correlations were found between changes in
4.75±1.49, p>0.05; environment: 3.99±1.20 and
quality of life and beta agonist use scores during
4.61±2.16, p>0.05. The intraclass correlation
the four weeks.
coefficients for total and domain scores were as
Discriminative properties follows: total, 0.71; symptoms, 0.81; activities,
0.96; emotional, 0.79; environment, 0.76.
Reliability
Cross-sectional construct validity
Figure 2 shows the total and domain scores of
AQLQ in patients of Group B at 0 and 4 wks. The Cross-sectional construct validity correlations
mean total score at 4 wks was 5.20±1.07 com- are shown in table 4. There were significant
pared to 4.83 ± 0.87 at 0 wk (p>0.05). Domain- correlations between total scores and the

Table 3. Longitudinal construct validity of asthma quality of life questionnaire


∆ Symptoms ∆Activity ∆Emotional ∆Environment Total
∆FEV1 –0.083 –0.080 –0.067 0.103 0.010
∆FEV1% predicted –0.017 –0.023 0.047 0.187 0.108
∆ACQ –0.631** –0.512** –0.461* –0.272 0.583**
Diary Scores
Cough 0.363* 0.277 0.750 0.736 0.331
Breathlessness 0.353 0.193 0.09 0.020 0.161
Sputum 0.450* 0.025 0.148 0.112 0.283
Nocturnal asthma 0.455* 0.124 0.148 0.112 0.237
Beta-2 agonist score 0.298 0.266 0.222 0.283 0.277
∆: Change; *:p<0.05; **:p<0.01.

Table 4. Cross sectional construct validity of asthma quality of life questionnaire


Symptoms Activity Emotional Environment Total
FEV1% predicted 0.128 –0.176 0.323 0.228 0.176
ACQ –0.753** –0.246 –0.522** –0.303 –0.625**
**:p<0.01.
172 Asthma Quality of Life S.K. Chhabra and S. Kaushik

symptoms and emotions domain scores of the nocturnal asthma. There were no correlations
AQLQ and the ACQ scores. The strongest between spirometric indices i.e. ∆FEV 1
correlation was seen between the symptom (∆= Change) and ∆FEV1% predicted and total or
domain of the AQLQ and the ACQ score. On the domain-wise scores of AQLQ. The strong
other hand there was no significant relationship correlation between ∆AQLQ scores and the
with the FEV1% predicted. ∆ACQ scores is understandable as the ACQ
evaluates the control over the past one week
All of our patients considered the questions
and the patients with good control should have
in the questionnaires to be relevant to their
better AQLQ scores and more so in the
asthmatic condition and there was apparently
symptom domain of the AQLQ as five of the
no difficulty in understanding of any of the
seven questions in the ACQ pertain to
questions.
symptoms. The poor correlation with FEV1 can
also be explained as FEV1 is a single measure-
DISCUSSION ment in time, and in the natural course of any
asthmatic patient, there are swings in FEV1. The
The present study shows that UK-English AQLQ assesses the patient’s state over the
version of Juniper ’s Asthma Quality of Life previous two weeks and thus may not correlate
Questionnaire (AQLQ) has sufficiently accep- well with the lung function. The correlations
table evaluative and discriminatory properties between changes in scores of AQLQ and the
for Indian asthmatic subjects and is therefore a ∆ACQ were stronger than with the diary scores.
valid instrument for quality of life Juniper et al 3 in their previous study have
measurements in clinical and research studies in reported more or less similar results.
asthmatics in India.
In the absence of a gold standard, validity of
In comparison to the nine stable patients, a questionniare may be established by showing
twenty-one asthmatic subjects in our study who correlations between the questionnaire and
improved on treatment showed an impro- other related outcomes (cross-sectional
vement in the AQLQ total scores and all other construct validity). This was done by relating
domains of the AQLQ except the environment the total and the domains scores of AQLQ to
domain. All the subjects who showed improve- clinical asthma severity i.e. ACQ and FEV 1%
ment had an increase in the mean total scores by predicted. We found moderately significant
more than one, which is suggestive of a mode- correlations between the ACQ and some of the
rate change in quality of life16. When within- domains and the total scores of AQLQ (r=0.522
subjects changes were examined in the impro- to 0.753). No correlation was seen with the
ved group of patients, improvement was seen in FEV 1% predicted. It is known that there is a
both the total scores as well as all the domains of wide range of HRQoL scores for a given level of
the AQLQ. However in stable patients, there lung function18. Degree of airways obstruction is
was no change in total or domain-wise quality only one of the possible determinants of quality
of life scores. These observations on the respon- of life. Thus, it can be argued that FEV 1 alone
siveness of the AQLQ are in agreement with should not be used to define subjects into
other studies 17. No change in quality of life various categories of severity of asthma.
scores in stable patients in our study shows that As a validated Hindi version of AQLQ was
the questionnaire had good reproducibility. not available at the time we carried out this
In longitudinal correlations, positive relation- study, the UK English version was used. Hence,
ships were found between changes in AQLQ knowledge of English language was one of the
and ACQ scores. The strongest correlation was inclusion criteria. In India, people who are
found with the symptoms domain of the AQLQ fluent in English are generally better-off
(r=0.631). The symptoms domain of the AQLQ economically. Therefore, extrapolating these
also showed significant correlations with the results to all social and economic classes would
diary scores of cough, expectoration and be difficult. However, given its acceptable
2005; Vol. 47 The Indian Journal of Chest Diseases & Allied Sciences 173

discriminative and evaluative properties 8. Apter J, Reisine T, Affleck G, Barrows E,


observed in the present study, the AQLQ needs Zuwallack R. The influence of demographic
to be studied in a wider spectrum of patients and socioeconomic factors on health - related
with diverse educational and economic quality of life in asthma. J Allergy Clin Immunol
1999; 103: 72-8.
backgrounds. A Hindi version of the AQLQ has
recently been developed and such studies 9. National Asthma Education and Prevention
should be possible now. Leidy et al19 described Program. Expert Panel Report–Guidelines for
the AQLQ as a useful indicator of health related diagnosis and management of asthma.
quality of life in low income asthmatics. Bethesda MD: National Institutes of Health;
1997; Publication no. 97.
To conclude, the AQLQ developed by Juniper
10. American Thoracic Society: 1994 Update.
et al3 has acceptable evaluative and discrimi- Standardization of spirometry. Am J Respir Crit
natory properties for use in Indian asthmatic Care Med 1995; 152: 1107-36.
patients.
11. Jain SK, Ramiah TJ. Spirometric indices in
healthy men and women 15-40 years age.
ACKNOWLEDGEMENTS
Indian J Chest Dis 1967; 9: 1-8.
The authors wish to thank Prof. Elizabeth Juniper
12. Juniper EF, O’Byrne PM, Guyatt GH, Ferrie PJ,
for her kind permission to use the UK English
King DR. Development and validation of a
version of the AQLQ.
questionnaire to measure asthma control. Eur
Respir J 1999; 14: 902-7.
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174 The Indian Journal of Chest Diseases & Sciences 2005; Vol. 47

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