Abstracts
Our objective was to evaluate the reproducibility of Asthma Control Questionnaire 7 (ACQ-7) in asthma patients, comparing our results against those obtained with the Global Initiative for Asthma (GINA) criteria. We evaluated 52 patients. Patients completed the ACQ-7, underwent spirometry, and were clinically assessed to determine the level of asthma control according to the GINA criteria, in two visits, 15 days apart. The ACQ-7 cutoff for uncontrolled asthma was a score of 1.5. The ACQ-7 showed good reproducibility, with a correlation coefficient of 0.73. The ACQ-7 identified a greater number of patients with uncontrolled asthma than did the GINA criteria; according to the GINA criteria, 47 patients (90.4%) presented with partially controlled asthma.
Asthma; Asthma; Questionnaires
Nosso objetivo foi avaliar a reprodutibilidade do Asthma Control Questionnaire 7 (ACQ-7) em asmáticos e comparar os resultados com os critérios de controle da Global Initiative for Asthma (GINA). Foram avaliados 52 pacientes em duas visitas com intervalo de 15 dias entre si. Os pacientes responderam o ACQ-7, realizaram espirometria e foram avaliados clinicamente para verificar o controle da asma de acordo com a GINA nas duas visitas. Em relação ao ACQ-7, o ponto de corte para asma não controlada foi definido em 1,5. Os resultados de ACQ-7 demonstraram boa reprodutibilidade, com coeficiente de correlação de 0,73. O ACQ-7 identificou um maior número de pacientes com asma não controlada em relação aos critérios da GINA; segundo os critérios GINA, 47 pacientes (90,4%) tinham asma parcialmente controlada.
Asma/prevenção e controle; Asma/classificação; Questionários
The objectives of asthma treatment are to control symptoms, prevent exacerbations, achieve
the best possible lung function, allow patients to perform their regular activities, and
prevent irreversible airway obstruction and death from asthma.(
11. Diretrizes da Sociedade Brasileira de Pneumologia e Tisiologia para o
Manejo da Asma. J Bras Pneumol. 2012;38(Suppl 1):S1-S46.
) Asthma control can be monitored in a variety of ways. Spirometry is a
noninvasive technique to evaluate lung function in children who have asthma and are over 5
years of age. However, spirometry has limitations, which include the need for a
professional trained in performing the test and the need for patient understanding and
cooperation. Other noninvasive methods for monitoring asthma include measurement of peak
expiratory flow, measurement of exhaled nitric oxide, and sputum examination for
inflammatory cells.(
22. Kazani S, Israel E. Update in Asthma 2011. Am J Respir Crit Care Med.
2012;186(1):35-40.
https://doi.org/10.1164/rccm.201204-0634...
) Asthma control questionnaires and quality of life questionnaires can be used
in order to assess asthma control.(
11. Diretrizes da Sociedade Brasileira de Pneumologia e Tisiologia para o
Manejo da Asma. J Bras Pneumol. 2012;38(Suppl 1):S1-S46.
)
In clinical practice, incorrect assessment of asthma control can result in inappropriate
treatment. Therefore, efforts to provide physicians and patients with simple, rapid, and
inexpensive instruments for accurate assessment of symptom control are warranted. The ideal
tool should have good reproducibility and responsiveness, should provide cutoffs for
uncontrolled asthma, should be practical, and should not pose health risks.(
33. Cloutier MM, Schatz M, Castro M, Clark N, Kelly HW, Mangione-Smith R,
et al. Asthma outcomes: composite scores of asthma control. J Allergy Clin Immunol.
2012;129(3 Suppl):S24-33.
https://doi.org/10.1016/j.jaci.2011.12.9...
) Asthma control questionnaires are therefore important for the evaluation of
disease control.
There are currently 17 previously validated questionnaires, all of which include questions
regarding nocturnal symptoms and sleep disturbances; most assess the frequency of symptoms,
the use of short-acting β2 agonists, and how asthma symptoms affect the
performance of activities of daily living and physical exercise.(
33. Cloutier MM, Schatz M, Castro M, Clark N, Kelly HW, Mangione-Smith R,
et al. Asthma outcomes: composite scores of asthma control. J Allergy Clin Immunol.
2012;129(3 Suppl):S24-33.
https://doi.org/10.1016/j.jaci.2011.12.9...
)
One useful instrument is the Asthma Control Questionnaire (ACQ), which can be administered
to asthma patients who are 12 years of age or older; the Spanish version and, more
recently, the Brazilian Portuguese version of the ACQ have been validated for
use.(
44. Leite M, Ponte EV, Petroni J, D'Oliveira A, Pizzichini E, Cruz AA.
Evaluation of the asthma control questionnaire validated for use in Brazil. J Bras
Pneumol. 2008;34(10):756-63.
https://doi.org/10.1590/S1806-3713200800...
) However, the reproducibility and responsiveness of ACQ-7, which includes six
questions and one lung function parameter, have yet to be evaluated in Brazil.
The objectives of the present study were to evaluate the reproducibility of ACQ-7 and to compare ACQ-7 with the Global Initiative for Asthma (GINA) criteria in terms of their utility in identifying controlled and uncontrolled asthma.
The inclusion criteria were as follows: being 12 years of age or older; being under
follow-up at one of the specialized clinics of the Federal University of Paraná School
of Medicine Hospital de Clínicas, located in the city of Curitiba,
Brazil; having been diagnosed with asthma and having received a diagnosis of asthma
severity in accordance with the GINA criteria(
55. Global Initiative for Asthma - GINA. [homepage on the Internet].
Bethesda: Global Initiative for Asthma. [cited 2013 Nov 11]. Global Strategy for
Asthma Management and Prevention. Available from: www.ginaasthma.org
Available from:
www...
); having received treatment with 800 µg/day of inhaled beclomethasone or
equivalent, with or without long-acting β2 agonists, in the last six months. The
exclusion criteria were as follows: need for systemic corticosteroids in the last three
months; history of smoking in the last three months; current pregnancy; and presence of
severe comorbidities.
Patients were assessed in two visits, the second occurring 15 days after the first. In the
two visits, patients completed ACQ-7 and were evaluated by a specialist, who determined the
level of asthma control on the basis of the GINA criteria.(
55. Global Initiative for Asthma - GINA. [homepage on the Internet].
Bethesda: Global Initiative for Asthma. [cited 2013 Nov 11]. Global Strategy for
Asthma Management and Prevention. Available from: www.ginaasthma.org
Available from:
www...
)
Patients completed the Brazilian Portuguese version of ACQ-7, which had previously been
validated. The ACQ-7 cutoff for controlled asthma was a score = 0.75, and the ACQ-7 cutoff
for uncontrolled asthma was a score = 1.5.(
66. Juniper EF, Bousquet J, Abetz L, Bateman ED; GOAL Committee.
Identifying 'well-controlled' and 'not well-controlled' asthma using the Asthma
Control Questionnaire. Respir Med. 2006;100(4):616-21.
https://doi.org/10.1016/j.rmed.2005.08.0...
)
Spirometry was performed with a portable spirometer (Microlab; Micro Medical Ltd., Rochester, UK), the Spida 5 software (Micro Medical Ltd.) and previously established reference values being used.( 77. Pereira CA, Barreto SP, Simões JG, Pereira FW, Gerstler JG, Nakatani J. Valores de referência para espirometria em uma amostra da população brasileira adulta. J Pneumol. 1992;18(1):10-22. ) In the two visits, spirometry was performed by the same professional, who was trained and qualified to do so. Values of FEV1 = 80% were considered normal.( 88. Sociedade Brasileira de Pneumologia e Tisiologia. Diretrizes para teste de função pulmonar - espirometria. J Bras Pnemol. 2002;28(3):S2-S82. ) The level of asthma control was determined by a specialist, on the basis of the GINA criteria. However, because the specialist had no access to the spirometry results or ACQ-7 scores during the consultation, FEV1 was not taken into consideration.
Categorical variables are presented as frequency distributions, and continuous variables are presented as the mean percentage of absolute values. Statistical analysis was performed with the GraphPad Prism software (GraphPad Software Inc., San Diego, CA, USA). Pearson's correlation test was used in order to determine the ACQ-7 interclass correlation coefficient, the Wilcoxon test was used in order to determine the differences in FEV1 between the two visits, and the chi-square test was used in order to compare the variables. A convenience sample was used.
The study was approved by the Human Research Ethics Committee of the Federal University of Paraná Hospital de Clínicas. All patients gave written informed assent, consent, or both.
A total of 52 patients were included in the present study. The median age was 16.5 years (range, 12-84 years), and 65% of the patients were female. The mean height was 160.3 ± 7.5 cm, and the mean body mass index was 25.5 ± 6.3 kg/m2. Regarding asthma severity before treatment initiation, half of the patients were classified as having mild persistent asthma and half were classified as having moderate persistent asthma.
In order to evaluate the reproducibility of ACQ-7, we used the interclass correlation test for the ACQ-7 scores obtained in the initial visit and those obtained 15 days later (Figure 1).
Correlation between the Asthma Control Questionnaire 7 (ACQ-7) scores obtained in the initial visit and those obtained 15 days later in the 52 patients studied. r = 0.73; 95% CI: 0.58-0.83; p < 0.0001.
A correlation coefficient of 0.73 was found, showing that the ACQ-7 scores obtained in the two visits correlated well. In order to determine whether there were any differences between asthma severity as assessed in the first visit and asthma severity as assessed in the second visit, we evaluated the variable FEV1 in isolation. No significant differences were found (p = 0.15).
We found no correlation between ACQ-7 scores and the level of asthma control by the GINA criteria (Table 1).
Identification of patients with controlled asthma on the basis of the Global Initiative for Asthma criteria and Asthma Control Questionnaire 7 scores.
Although 23 patients had ACQ-7 scores = 1.5 (i.e., uncontrolled asthma), only 2 were classified as having uncontrolled asthma on the basis of the GINA criteria. Of the 47 patients with partially controlled asthma by the GINA criteria, 22 were classified as having uncontrolled asthma on the basis of their ACQ-7 scores (i.e., = 1.5).
We found no correlation between FEV1 and the level of asthma control as determined by the GINA criteria. Most (90.3%) of the 52 patients included in the study were classified as having partially controlled asthma on the basis of the GINA criteria. Of those, 21 (45%) had FEV1 > 80% and 26 (55%) had FEV1 < 80%.
Of the 17 previously validated asthma control and quality of life questionnaires for
monitoring symptoms in asthma patients, only 2 include items on lung function parameters:
ACQ-7 and the Asthma Control Scoring System.(
33. Cloutier MM, Schatz M, Castro M, Clark N, Kelly HW, Mangione-Smith R,
et al. Asthma outcomes: composite scores of asthma control. J Allergy Clin Immunol.
2012;129(3 Suppl):S24-33.
https://doi.org/10.1016/j.jaci.2011.12.9...
) The confirmation of the reproducibility of the Brazilian Portuguese version of
ACQ-7 provides an instrument that includes items covering subjective symptoms and one lung
function parameter and that can be used in clinical practice and research, its validity
having been confirmed.(
44. Leite M, Ponte EV, Petroni J, D'Oliveira A, Pizzichini E, Cruz AA.
Evaluation of the asthma control questionnaire validated for use in Brazil. J Bras
Pneumol. 2008;34(10):756-63.
https://doi.org/10.1590/S1806-3713200800...
)
We found no significant differences between the ACQ-7 scores obtained in the first visit and those obtained in the second. Because FEV1 values were similar between the two visits, ACQ-7 scores were expected to be similar as well. The fact that they were demonstrates the good reproducibility of ACQ-7.
In the present study, the level of asthma control as determined by ACQ-7 scores differed from the level of asthma control as determined by the GINA criteria. We found that ACQ-7 was more effective in identifying patients with uncontrolled asthma. These data show that the use of an instrument that includes items covering clinical symptoms and lung function parameters on an objective point scale can provide information to facilitate the clinical management of patients, given that asthma treatment progression is based primarily on the level of asthma control.
In a study similar to ours, the GINA criteria were compared with the Asthma Control Test
(ACT), which is a 5-item questionnaire that does not include items on lung function
parameters. It was concluded that ACT scores = 19 were useful in identifying patients
classified as having uncontrolled or partially controlled asthma on the basis of the GINA
criteria.(
99. Thomas M, Kay S, Pike J, Williams A, Rosenzweig JR, Hillyer EV, et
al. The Asthma Control Test (ACT) as a predictor of GINA guideline-defined asthma
control: analysis of a multinational cross-sectional survey. Prim Care Respir J.
2009;18(1):41-9.
https://doi.org/10.4104/pcrj.2009.00010...
) Although the ACT does not include items on lung function parameters, the ACT
cutoff for uncontrolled asthma correlates well with the ACQ.(
1010. Schatz M, Sorkness CA, Li JT, Marcus P, Murray JJ, Nathan RA, et al.
Asthma Control Test: reliability, validity, and responsiveness in patients not
previously followed by asthma specialists. J Allergy Clin Immunol.
2006;117(3):549-56.
https://doi.org/10.1016/j.jaci.2006.01.0...
) Therefore, the GINA criteria were expected to correlate well with ACQ scores.
However, we found no such correlation in the present study.
We found that some of the patients who were classified as having partially controlled
asthma on the basis of the GINA criteria had normal FEV1, whereas others had
reduced FEV1. This finding suggests that the definition of partially controlled
asthma does not accurately reflect lung function. When a patient is classified as having
partially controlled asthma on the basis of the GINA criteria, the significance of this
classification should be questioned, given that the patient might or might not have normal
pulmonary function test results. In such patients, FEV1 should be measured in
order to aid in making treatment decisions, given that it provides complementary
information and is weakly associated with symptoms.(
1111. Reddel HK, Taylor DR, Bateman ED, Boulet LP, Boushey HA, Busse WW.
An official American Thoracic Society/European Respiratory Society statement: asthma
control and exacerbations: standardizing endpoints for clinical asthma trials and
clinical practice. Am J Respir Crit Care Med. 2009;180(1):59-99.
https://doi.org/10.1164/rccm.200801-060S...
)
The present study has some limitations. First, the ACQ-7 cutoffs aid in distinguishing
between controlled and uncontrolled asthma; that is, they do not aid in assessing partially
controlled asthma. Second, the GINA criteria and the National Asthma Education and
Prevention Program lack a clear definition of asthma control.(
1212. Jia CE, Zhang HP, Lv y, Liang R, Jiang YQ, Powell H, et al. The
Asthma Control Test and Asthma Control Questionnaire for assessing asthma control:
Systematic review and meta-analysis. J Allergy Clin Immunol 2013; 131(3):
695-703.
https://doi.org/10.1016/j.jaci.2012.08.0...
)
In conclusion, ACQ-7 showed good reproducibility in the present study. In addition, in the patients over 12 years of age in our sample, the level of asthma control by the GINA criteria differed from the level of asthma control as assessed by ACQ-7 scores, and ACQ-7 identified a greater number of patients with uncontrolled asthma than did the GINA criteria.
References
-
1Diretrizes da Sociedade Brasileira de Pneumologia e Tisiologia para o Manejo da Asma. J Bras Pneumol. 2012;38(Suppl 1):S1-S46.
-
2Kazani S, Israel E. Update in Asthma 2011. Am J Respir Crit Care Med. 2012;186(1):35-40.
» https://doi.org/10.1164/rccm.201204-0634UP -
3Cloutier MM, Schatz M, Castro M, Clark N, Kelly HW, Mangione-Smith R, et al. Asthma outcomes: composite scores of asthma control. J Allergy Clin Immunol. 2012;129(3 Suppl):S24-33.
» https://doi.org/10.1016/j.jaci.2011.12.980 -
4Leite M, Ponte EV, Petroni J, D'Oliveira A, Pizzichini E, Cruz AA. Evaluation of the asthma control questionnaire validated for use in Brazil. J Bras Pneumol. 2008;34(10):756-63.
» https://doi.org/10.1590/S1806-37132008001000002 -
5Global Initiative for Asthma - GINA. [homepage on the Internet]. Bethesda: Global Initiative for Asthma. [cited 2013 Nov 11]. Global Strategy for Asthma Management and Prevention. Available from: www.ginaasthma.org
» Available from: www.ginaasthma.org -
6Juniper EF, Bousquet J, Abetz L, Bateman ED; GOAL Committee. Identifying 'well-controlled' and 'not well-controlled' asthma using the Asthma Control Questionnaire. Respir Med. 2006;100(4):616-21.
» https://doi.org/10.1016/j.rmed.2005.08.012 -
7Pereira CA, Barreto SP, Simões JG, Pereira FW, Gerstler JG, Nakatani J. Valores de referência para espirometria em uma amostra da população brasileira adulta. J Pneumol. 1992;18(1):10-22.
-
8Sociedade Brasileira de Pneumologia e Tisiologia. Diretrizes para teste de função pulmonar - espirometria. J Bras Pnemol. 2002;28(3):S2-S82.
-
9Thomas M, Kay S, Pike J, Williams A, Rosenzweig JR, Hillyer EV, et al. The Asthma Control Test (ACT) as a predictor of GINA guideline-defined asthma control: analysis of a multinational cross-sectional survey. Prim Care Respir J. 2009;18(1):41-9.
» https://doi.org/10.4104/pcrj.2009.00010 -
10Schatz M, Sorkness CA, Li JT, Marcus P, Murray JJ, Nathan RA, et al. Asthma Control Test: reliability, validity, and responsiveness in patients not previously followed by asthma specialists. J Allergy Clin Immunol. 2006;117(3):549-56.
» https://doi.org/10.1016/j.jaci.2006.01.011 -
11Reddel HK, Taylor DR, Bateman ED, Boulet LP, Boushey HA, Busse WW. An official American Thoracic Society/European Respiratory Society statement: asthma control and exacerbations: standardizing endpoints for clinical asthma trials and clinical practice. Am J Respir Crit Care Med. 2009;180(1):59-99.
» https://doi.org/10.1164/rccm.200801-060ST -
12Jia CE, Zhang HP, Lv y, Liang R, Jiang YQ, Powell H, et al. The Asthma Control Test and Asthma Control Questionnaire for assessing asthma control: Systematic review and meta-analysis. J Allergy Clin Immunol 2013; 131(3): 695-703.
» https://doi.org/10.1016/j.jaci.2012.08.023
-
*
Study carried out in the Department of Allergy and Immunology, Federal University of Paraná School of Medicine Hospital de Clínicas, Curitiba, Brazil.
Publication Dates
-
Publication in this collection
Mar-Apr 2014
History
-
Received
17 Jan 2014 -
Accepted
17 Mar 2014