A prospective study to assess the quality of life in children with asthma using the pediatric asthma quality of life questionnaire

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1 original article A prospective study to assess the quality of life in children with asthma using the pediatric asthma quality of life questionnaire Sathyajith Nair, Sajitha Nair, K. R. Sundaram 1 Access this article online Website: DOI: / Quick Response Code: ABSTRACT Objectives: The objective of the following study is to assess the quality of life (QOL) in children with asthma using the mini pediatric asthma quality of life questionnaire (mini PAQLQ) with treatment and from the caregiver s point of view using the pediatric asthma caregivers quality of life questionnaire (PACQLQ). Materials and Methods: Of the 75 children with asthma in the age group from 7 to 17 years of age, 69 were included in the study. The QOL was assessed using the mini PAQLQ and PACQLQ. An asthma clinical severity score was also used to assess the clinical condition simultaneously. Results: On treatment, there was a significant change in the activity and symptom category of the mini PAQLQ (P < 0.001), but there was no significant change in the emotional domain of the mini PAQLQ even after medical intervention (P = 0.563). This indicates that although the activity level of children improved with significant symptomatic improvement, these children did not recover emotionally from the impact of the disease with medical intervention. There was a significant change noted in both the activity and emotional domain of the PACQLQ with treatment. Conclusions: Although the children improved clinically with treatment there was no significant change in the emotional domain of mini PAQLQ. Inspite of there being a positive change in the groups after intervention, no statistically significant change was noted in the PAQLQ scores. Management of a child with asthma should not only include medical intervention but also psychological support and counseling. Key words: Asthma clinical severity score, asthma quality of life, mini pediatric asthma quality of life questionnaire, pediatric asthma quality of life questionnaire INTRODUCTION Asthma is a problem worldwide, with an estimated 300 million affected individuals and is the most common chronic disease in childhood, with prevalence of 10 30%. [1] Quality of life (QOL) is defined by the individual and depends on many factors such as life style, past experiences, hopes for the future, dreams and ambitions. QOL for a child with asthma has been defined as the measure of emotions, asthma severity/symptoms, missed school Departments of Pediatrics, and 1 Bio Statistics, Amrita Institute of Medical Sciences, Kochi, Kerala, India Address for correspondence: Dr. Sathyajith Nair, Department of Pediatrics, Amrita Institute of Medical Sciences, Kochi, Kerala, India. E mail: sathyanng@yahoo.com Indian Journal of Allergy, Asthma and Immunology Jan-Jun 2014 Volume 28 Issue 1 13

2 days, activity limitations and visits to the emergency department. Several studies of children with asthma have indicated that the child s QOL reports may differ from those of their parents. Regardless of the definition of QOL and despite differences in definitions between rural and urban families, most studies indicate that children with asthma and their families experience significant impairment in QOL. [1] Children with very severe asthma tend to have worse QOL than children with milder disease. However recent research has shown that QOL does not correlate closely with asthma control and is a very distinct component of overall asthma health status. [2 4] Our concern nowadays is to allow the asthmatic patients to lead a better life and improve their QOL. As there is a paucity of data on QOL of asthma patients in India, a prospective study was undertaken. Objectives To assess the QOL in children with asthma using the mini pediatric asthma quality of life questionnaire (mini PAQLQ) with treatment and from the caregiver s point of view using the pediatric asthma caregivers quality of life questionnaire (PACQLQ). MATERIALS AND METHODS This study was conducted in the Department of Pediatrics of the Amrita Institute of Medical Sciences and Research Centre, Kochi over a period of 1 year. The children included in the study were those attending the outpatient Department of Pediatrics of our hospital in the age group 7 17 years in whom a diagnosis of asthma was made as per global initiative for asthma (GINA) 2008 guidelines and those parents and children diagnosed as asthma who could read and answer the questionnaire in English (mini PAQLQ and PACQLQ). These are QOL questionnaires developed by Juniper et al. who are pioneers in formulating the different PAQLQ. Mini PAQLQ has 13 questions with 3 domains (activity limitation, symptoms and emotion) and the PACQLQ has 13 questions with 2 domains (activity limitation and emotion). [5 10] Children with asthma on systemic steroid therapy in the last 2 weeks, those with chronic systemic illness other than asthma, recurrent chest infections needing treatment with antibiotics and those who refused to participate their children in the study were excluded from the study. [10] An informed consent was obtained from the caregivers of the patients before the start of the study. A detailed history, clinical examination and relevant investigations were done to rule out any infective focus. These children were classified into various types of asthma as per the GINA 2008 guidelines. Asthma clinical severity (ACS) scoring was also done at presentation. The children and their caregivers were asked to answer the self administered mini PAQLQ and PACQLQ at the first visit. An ACS score which included evaluation of symptoms and signs of asthma with peak expiratory flow rate (PEFR) was documented. The ACS score was adapted from the original study by Juniper et al. [6] The score included the presence of night time symptoms, presence of day time symptoms, use of inhaled β 2 agonists more than twice a day, daily activity limitation, presence of expectoration and peak flow meter recordings below 80% of the predicted value as per the normogram for South Indian Children developed by Swaminathan et al. [11,12] The desired medical intervention for the asthma was given as per the GINA Guidelines All patients in the study were reviewed after 4 weeks. During the follow up identical questionnaires along with the ACS scores and the PEFR were reassessed. On follow up patients were assessed in terms of their clinical stability. They were subdivided into four groups based on the change in status in the 2 nd visit. Group 1 (n 16) consisted of those who remained in the mild category, Group 2 (n 10) consisted of those who remained in the moderate/severe category, Group 3 (n 41) consisted of those who changed from the moderate/severe to the mild category and Group 4 (n 2) were those who changed from the mild to the moderate/severe category. As Group 4 consisted of just two patients, it was not included in the analysis. Sample size No study comparing the QOL scores with respect to the ACS score could be located in literature, hence this will be a pilot study. Statistical analysis 1. Mean and standard deviation of QOL scores were computed with respect to ACS score group (mild/ moderate/severe) at pre drug and post drug stages. 2. Mean and standard deviation of QOL scores were also computed at pre and post drug stages for stable and the unstable group separately. 3. To test the statistical significance of the difference in QOL scores between pre and post periods for the total sample and also with respect to stable and unstable groups, Student s t test was applied. 4. To test the statistical significance of the change in QOL scores from the pre- to post periods, paired t test was done. 5. To test the statistical difference of the differences in the mean PAQLQ and PACQLQ scores at the follow up period, analysis of co variance was applied, after taking into consideration the differences in the pre volumes among the 3 groups. Approval for the study was obtained from the ethical committee of the home institution. Permission was also obtained for using the original mini PAQLQ and the PACQLQ in our study. 14 Indian Journal of Allergy, Asthma and Immunology Jan-Jun 2014 Volume 28 Issue 1

3 RESULTS Out of the total of 69 cases, 66.7% (46) of the cases were in the age group 7 12 years and 33.33% (23) were in the age groups of years of age. Of the total number of cases, 78% (54) were boys and the rest 22% (15) were girls. The mean age of children in the study group was years with a standard deviation of Children with asthma were classified into various types as per the GINA 2008 guidelines. Mild intermittent asthma was seen in 13.04% (9) cases. Mild persistent type of asthma was seen in 33.33% (23) cases and 53.62% (37) were classified as moderate persistent type of asthma. No cases of severe persistent asthma were present in our study. Based on the asthma severity scores (ASS), the children were classified as mild or moderate/severe at each visit separately [Table 1]. Further subdivisions in classification were done based on the change of category after 4 weeks of treatment, i.e. stable (those remaining in the same clinical severity group) and unstable (those who changed groups, turning from mild into moderate/severe or vice versa). As per the ACS score, assessed before and after treatment, the majority of cases 62.3% (43) changed their stability and were in the unstable group and 37.6% (26) were in the stable group. The mean ACS scores [Table 2] showed a statistically significant change (P < 0.001) after 4 weeks of treatment indicating an objective improvement in the clinical status of the child with treatment. Statistically significant increase in the activity limitation and the symptom category of the mini PAQLQ (P < 0.001) after treatment was noted. There was also a significant change in the mean grand total scores showing an overall improvement in the child s condition with medical intervention. However, no statistically significant change was noted in the emotional domain of the mini PAQLQ even after medical intervention as noted in Table 3. This indicates that although the activity level of children improved with significant symptomatic improvement, the child did not recover emotionally from the impact of the disease with medical intervention. On statistical analysis of the QOL from the caregiver s point of view, significant change (P < 0.001) was noted in the mean scores of both the activity and emotion domains of PACQLQ with treatment [Table 3]. The Mean of the grand mean total of PACQLQ also showed a significant statistical change. Although the parents in our study perceived that the child showed improvement both in activity and emotional aspects with treatment, on statistical analysis of mini PAQLQ, the children did not recover emotionally from the impact of disease with treatment. Thus in the present study, parents were not able to understand the psychological effects of asthma on their children. Table 1: Classification of children into mild and moderate/severe as per ACS score before and after intervention Status Pre Post Number (n=69) Percentage Number (n=69) Percentage Mild Moderate/severe ACS Asthma clinical severity Table 2: ACS scores taken at the time of recording the PAQLQ Variable (n=69) Mean SD P value ACS score (pre) <0.001 ACS score (post) ACS Asthma clinical severity, SD Standard deviation, PAQLQ Pediatric asthma quality of life questionnaire Table 3: Analysis of the mean mini PAQLQ and the PACQLQ scores Pre (69) Post (69) P value Mean SD Mean SD PAQLQ (no. of items) Activity (3) <0.001 Symptom (6) <0.001 Emotion (4) Mean of grand total PAQLQ score (13) <0.001 PACQLQ (no. of items) Activity (4) <0.001 Emotion (9) <0.001 Mean of grand total PACQLQ score (13) <0.001 PAQLQ Pediatric asthma quality of life questionnaire, PACQLQ Pediatric asthma caregivers quality of life questionnaire, SD Standard deviation The patients were subdivided into three categories and further analyzed. There was improvement seen in the mean PAQLQ Activity limitation and symptom domains in all the groups as shown in Table 4. However, there was deterioration seen in the scores of the mean PAQLQ Emotion domain in the Groups 1 and 3. There was no significant improvement noted in the Group 2 in the emotion domain of the PAQLQ. In the analysis of the PACQLQ within the groups, there was an improvement in the scores in all the three groups. It was noted that after applying the analysis of co variance, it was noted that there was a significant change noted in the post values in the mean scores of the PAQLQ emotion domain between the Groups 1 and 2 and among the Groups 2 and 3. In the analysis of the PACQLQ domains between the three groups, it was observed that there was no statistically significant change observed among them. Thus even after a positive change after treatment in terms of a change in the groups, there was no significant change in the PAQLQ and the PACQLQ scores. The caregivers were not able to analyze the emotional deterioration that their children were subjected to in spite of the positive outcome in the symptoms and the activity as noted by both the child and the caregiver. Indian Journal of Allergy, Asthma and Immunology Jan-Jun 2014 Volume 28 Issue 1 15

4 Table 4: The scores of the PAQLQ and the PACQLQ in the three groups Variable Mean (SD) P P Group 1 (16) Group 2 (10) Group 3 (41) Group 1 and 2 Group 1 and 3 Group 2 and 3 Mean PAQLQ activity limitation score Pre 4.9 (1.54) 3.0 (1.77) 4.1 (1.24) Post 6.60 (0.8006) (0.8263) 6.44 (0.9177) Mean PAQLQ symptoms score Pre 5.3 (1.33) 3.1 (1.61) 4.5 (1.62) Post 6.34 (0.8075) (0.9277) 6.25 (0.9850) Mean PAQLQ emotions score Pre 5.40 (1.147) 4.67 (1.504) 5.18 (1.032) Post 4.70 (0.8574) (0.9413) 5.08 (1.0688) Mean of grand total PAQLQ score Pre 5.34 (1.2058) 3.63 (1.3250) 4.62 (1.1176) Post 5.98 (0.3148) 5.79 (0.6155) 5.94 (0.6622) Mean of total PACQLQ activity limitation score Pre 5.29 (1.5922) 3.90 (1.7368) 4.85 (1.4295) Post 6.3 (0.56) 5.5 (1.38) 6.1 (0.76) Mean of total PACQLQ emotions score Pre 4.64 (1.4355) 3.97 (1.3081) 4.57 (1.1316) Post 5.45 (0.8037) 5.27 (1.1706) 5.45 (0.8381) Mean of grand total of PACQLQ score Pre 4.84 (1.3746) 3.95 (1.3230) 4.66 (1.1166) Post 5.72 (0.6757) 5.27 (1.0523) 5.67 (0.7435) Note (A): Group 1 (n=16) those who remained in the mild category, Group 2 (n=10) those who remained in the moderate/severe category, Group 3 (n=41) those who changed from the moderate/severe to the mild category. Note (B): Post values on an average were compared between Groups 1 and 2, 1 and 3 and 2 and 3 applying analysis of co variance since their pre values among these groups were statistically significant. PAQLQ Pediatric asthma quality of life questionnaire, PACQLQ Pediatric asthma caregivers quality of life questionnaire, SD Standard deviation DISCUSSION Male predominance (3.6:1) was observed and also reported in the Brazilian study and the study by Juniper et al. which was similar to our study group. [13,14] In a study from Postgraduate Institute of Medical Education and Research, Chandigarh (PGIC), 85% of children in the study had moderate persistent asthma. [14] In the Brazilian study moderate persistent type of asthma accounted for 67.8%. [13] In the study from Turkey majority of cases (81.6%) belonged to the mild intermittent category. [15] In our study, the mini PAQLQ version of Juniper s QOL Questionnaire was used for assessment of QOL. Juniper in a study on PAQLQ(S) in 1998 showed that mini PAQLQ is a valid and reliable instrument for measuring QOL in children. They also found that the mini PAQLQ is easier to administer and complete and suitable for use in clinical practice. [10] PACQLQ was devised by Juniper et al. in The original study included 52 caregivers. The original PACQLQ contained 13 questions. The activity domain had 4 and the emotion domain had 9 questions. The study showed a statistically significant change (P 0.001) in the emotion and symptom domains and the total overall QOL. [9] These findings were similar to the findings of our study. Walker et al. in a study from Baltimore USA, found there was no association between parent and child s total QOL scores. The mean parental total QOL scores were higher at baseline and follow up than those of the children. [16,17] At follow up, a statistically significant relationship was found between the child s asthma severity level and the parents/caregivers emotion quality of life (EQOL) subscale (P = 0.009) and the parent/caregiver activity quality of life (AQOL) subscale (P = 0.03). There was evidence that children s perceptions differ from their parents judgment. There is paucity of published data on the QOL from a parent s perspective from India. In the original study devised by Juniper et al. in 1996, the questionnaire had 23 questions with 3 domains (activity limitation, symptoms and emotional function). Children were defined as asthma as per the American Thoracic Society guidelines. [6] The study included four visits over a period of 9 weeks. A statistically significant change was noted in the activity limitation, symptom domains and the overall PAQLQ scores in the unstable category. The scores of the emotion domain were not statistically significant in the unstable domain. [6] In the stable category, there was statistically moderate significance in all the domains and the overall scores. Juniper et al. also found moderate correlations between changes in questionnaire score and the asthma clinical control. [6] The Brazilian study which used the adapted PAQLQ for assessing the QOL in children found statistically no change in the emotion domain of the children in the stable category after two visits. [13] There was statistically significant change in the emotion domain in the unstable category. [13] They also observed no statistically significant change in the activity and symptom category of the stable category. However, in the unstable category, the symptom, emotion and the activity domain recorded statistically significant change in scores. In our study, there was stronger negative correlation in the stable category than in the unstable category. In a study by Walker 16 Indian Journal of Allergy, Asthma and Immunology Jan-Jun 2014 Volume 28 Issue 1

5 et al. from Baltimore, USA, the PAQLQ with 23 questions was used. [1] There was a trend toward a statistically significant relationship between asthma severity and the child s EQOL subscale. No significant relationship was seen between asthma severity and the child s AQOL subscale. [1] A study by Mussaffi et al. from Israel compared directly the PAQLQ and the PACQLQ with a sample size of 147. [18] He reported that the PAQLQ showed a severe impact of asthma on both the activity limitation and emotional domains. Parent s mean emotional score was significantly lower than that of the children, whereas the children s mean activity limitation score was significantly lower than that of the parents. Our study did not compare the PAQLQ and the PACQLQ directly. [18] In a study by Okelo et al., the child health and illness profile adolescent edition (CHIP AE) was used to assess emotional QOL which is an adapted version of Juniper s PAQLQ to study the relationship of pediatric asthma control score and emotional QOL. They found a significant change in the overall scores using the PAQLQ. [19] The study also showed that within the domains that the change in the emotion domain had only statistically moderate significance. The self esteem component of the CHIP AE did not show any statistically significant change. In our study, there was no statistical change in the emotion domain of the mini PAQLQ after two visits in spite of medical intervention. A study to assess the QOL was done by Singh et al. at the Postgraduate PGIC. The QOL tool used by the PGIC was an indigenously developed, pre tested, disease specific and culturally appropriate questionnaire for Indian children with bronchial asthma. This study has shown that improvement in QOL score with treatment compared well with improvement in objective measures of pulmonary function. In their study, improvement in symptom scores lagged behind improvement in QOL score and pulmonary functions, although the overall change was greater. [14] The author concluded that this indirectly indicates the efficacy of QOL score for measurement of clinical status. None of the studies reported in literature had observed for the change in the QOL within the groups over a period of the subsequent visits. In our study, on statistical analysis of data from mini PAQLQ questionnaire, it was seen that children with asthma had psychological problems, which persisted inspite of medical intervention. It is also interesting to note that parents in the study were not able to understand the psychological effects of asthma in their children. This stresses the importance of providing psychological support and counseling in the long term management of asthma. [20-23] CONCLUSIONS It is important to assess QOL in children with asthma. Mini PAQLQ is a simple quick, easy to understand questionnaire and can be used for assessment of QOL in children with asthma. In the present study, there was statistically significant change in activity, symptom and grand total scores of mini PAQLQ in children with asthma after medical intervention on follow up. ACS scores showed statistically significant change with medical intervention on follow up. Although the children improved clinically with treatment there was no significant change in the emotional domain of mini PAQLQ on follow up. Parents in the study failed to understand the psychological effects of asthma in their children. The application of the analysis of co variance among the three groups in the PAQLQ showed a change only in the scores of the mean PAQLQ in the emotion domain. No significant change was noted in the PACQLQ scores. Thus a change of the asthma severity from moderate/severe asthma to the mild category or for those who remained in the mild and moderate/severe categories, did not show any significant change on the PACQLQ scores. Management of a child with asthma should not only include medical intervention but also psychological support and counseling. The participation of a psychologist or counselor in the long term management of asthma in childhood should be made mandatory. Further studies are needed to evaluate in detail the various psychological problems in children with asthma. QOL questionnaire in the local languages needs to be developed and validated. REFERENCES 1. Walker J, Winkelstein M, Land C, Lewis Boyer L, Quartey R, Pham L, et al. Factors that influence quality of life in rural children with asthma and their parents. J Pediatr Health Care 2008;22: Juniper EF, Wisniewski ME, Cox FM, Emmett AH, Nielsen KE, O Byrne PM. 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6 12. Swaminathan S, Venkatesan P, Mukunthan R. Peak expiratory flow rate in south Indian children. Indian Pediatr 1993;30: La Scala CS, Naspitz CK, Solé D. Adaptation and validation of the Pediatric Asthma Quality of Life Questionnaire (PAQLQ) in Brazilian asthmatic children and adolescents. J Pediatr (Rio J) 2005;81: Singh M, Mathew JL, Malhi P, Srinivas BR, Kumar L. Comparison of improvement in quality of life score with objective parameters of pulmonary function in Indian asthmatic children receiving inhaled corticosteroid therapy. Indian Pediatr 2004;41: Boran P, Tokuç G, Pişgin B, Oktem S. Assessment of quality of life in asthmatic Turkish children. Turk J Pediatr 2008;50: Slevin ML, Plant H, Lynch D, Drinkwater J, Gregory WM. Who should measure quality of life, the doctor or the patient? Br J Cancer 1988;57: Herjanic B, Reich W. Development of a structured psychiatric interview for children: Agreement between child and parent on individual symptoms. J Abnorm Child Psychol 1982;10: Mussaffi H, Omer R, Prais D, Mei-Zahav M, Weiss-Kasirer T, Botzer Z, et al. Computerised paediatric asthma quality of life questionnaires in routine care. Arch Dis Child 2007;92: Okelo SO, Wu AW, Krishnan JA, Rand CS, Skinner EA, Diette GB. Emotional quality of life and outcomes in adolescents with asthma. J Pediatr 2004;145: Eksi A, Molzan J, Savasir I, Güler N. Psychological adjustment of children with mild and moderately severe asthma. Eur Child Adolesc Psychiatry 1995;4: Perrin JM, MacLean WE Jr, Gortmaker SL, Asher KN. Improving the psychological status of children with asthma: A randomized controlled trial. J Dev Behav Pediatr 1992;13: MacLean WE Jr, Perrin JM, Gortmaker S, Pierre CB. Psychological adjustment of children with asthma: Effects of illness severity and recent stressful life events. J Pediatr Psychol 1992;17: Hafkamp de Groen E, Mohangoo AD, de Jongste JC, van der Wouden JC, Moll HA, Jaddoe VW, et al. Early detection and counselling intervention of asthma symptoms in preschool children: Study design of a cluster randomised controlled trial. BMC Public Health 2010;10:555. How to cite this article: Nair S, Nair S, Sundaram KR. A prospective study to assess the quality of life in children with asthma using the pediatric asthma quality of life questionnaire. Indian J Allergy Asthma Immunol 2014;28:13-8. Source of Support: Nil, Conflict of Interest: None declared. 18 Indian Journal of Allergy, Asthma and Immunology Jan-Jun 2014 Volume 28 Issue 1