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of Life Research,
Measuring quality of life in the parents children with asthma
E. F. Juniper,* G. H. Guyatt, D. H. Feeny, I? J. Ferrie, L. E. Griffith and M. Townsend
Department of Clinical Epidemiology and Biostatistics, McMaster University Medical Centre, Hamilton, Ontario, Canada (E. F. Juniper, G. H. Guyatt, D. H. Feeny, P. J. Ferric, L. E. Griffith, M. Townsend); Department of Medicine, McMaster University Medical Centre, Hamilton, Ontario, Canada (G. H. Guyatt); Centre for Health Economics and Policy Analysis, McMaster University, Hamilton, Ontario, Canada (D. H. Feeny)
Parents and primary caregivers of children with asthma are limited in normal daily activities and experience anxieties and fears due to the child’s illness. We have developed the Paediatric Asthma Caregiver’s Quality of Life Questionnaire (PACQLQ) to measure these impairments. The objective of this study was to evaluate the measurement properties of the PACQLQ. A Qweek single cohort study was conducted with assessments at 1, 5 and 9 weeks. Participants in the study were primary caregivers of 52 children (age 7-17 years) with symptomatic asthma, recruited from notices in the local media and paediatric asthma clinics. Caregivers completed the PACQLQ, Impact-on-Family Scale and Global Rating of Change Questionnaires. Patients completed the Paediatric Asthma Quality of Life Questionnaire and an asthma control questionnaire. Spirometry and P-agonist use were recorded. The PACQLQ was able to detect quality of life changes in those caregivers who changed (p < 0.001) and to differentiate these from the caregivers whose quality of life remained stable (p < 0.0001). The PACQLQ is reproducible in subjects who are stable (ICC=O.84), and showed acceptable levels of longitudinal and cross-sectional correlations with the child’s asthma status and health-related quality of life and with other measures of caregiver healthrelated quality of life. The PACQLQ functions well as both an evaluative and a discriminative instrument. Key words: Asthma; paediatrics health-related quality of life;
Interest in the impact of illness on day-to-day function is leading investigators to include both diseasespecific and generic health-related quality of life (HRQOL) questionnaires in a broad range of clinical studies. However, illness not only has an impact on patients but also affects the quality of life of people associated with the patient. In childhood illnesses the family, and particularly the primary caregiver, may face a considerable burden. In a recent study, we showed that the primary caregivers of children with asthma are limited in their own normal daily activities and also experience anxieties and emotional stresses as a result of their children’s asthma.’ On the basis of these results, we developed the Paediatric Asthma Caregiver’s Quality of Life Questionnaire using methodsz3 that we have applied in the development of over 20 diseasespecific HRQOL questionnaires. In this paper, we briefly describe the methods used for the development of the questionnaire and present in detail the methods and results of a study in which we examined the measurement properties of the Paediatric Asthma Caregiver’s Quality of Life Questionnaire. We addressed four questions: (1) In caregivers whose HRQOL remains stable, what is the reliability of the questionnaire? (2) In caregivers whose HRQOL changes, are we able to detect these changes even if the changes are small (responsiveness)? (3) What change in score can be considered important? (4) Is the questionnaire valid, i.e. does it actually measure the HRQOL of the caregivers of children with asthma?
To whom correspondence should be addressed at Department of Clinical Epidemiology and Biostatistics, McMaster University Medical Centre, 1200 Main Street West, Hamilton, Ontario, Canada, L8N 325. Phone: 905-525-9140 x 22153; Fax: 905-577-0017; email: Juniper@fhs.mcmaster.ca
of Life Research
5=bothers me very. actually measure quality of life in the caregivers of children with asthma. E @@er et al. In general. Children over 12 years of age and all the caregivers signed an informed consent that had been approved by the McMaster University Faculty of Health Sciences Ethics Committee. activity limitation and emotional function) and measures HRQOL in patients with asthma age 7-17 years. We weight individual items within the questionnaire equally and express the results as the mean score per item for each of the domains (emotional function and activity limitation) as well as for overall quality of life. (3) be reproducible when the caregiver’s quality of life is in a stable state. the caregiver completed the Paediatric Asthma Caregiver’s Quality of Life Questionnaire and the Impact-on-Family Scale. We have described. For one week before each of the follow-up visits. Responses to each item in the Paediatric Asthma Caregiver’s Quality of Life Questionnaire are given on a 7-point scale where 1 represents severe impairment and 7 represents no impairment. the caregiver rated the importance on a 5-point scale (l=does not bother me much.E.e. We recruited the primary caregiver. The children were between 7 and 17 years and represented a wide range of asthma severity as judged by medication requirements. It includes 23 items in three domains (symptoms. very much). Methods Participants We have described the patient population who participated in this study and its basic methods in another publication! In brief. the child completed the Paediatric Asthma Quality of Life Questionnaire. notices in the local media and through patients who had participated in our adult asthma research studies. At each clinic visit.’ In brief. items identified most frequently and rated most bothersome were those included in the questionnaire. we recruited 52 children with current symptoms of asthma and their primary caregiver from local paediatric asthma clinics. caregivers of children with asthma. who lived with the child at least 75% of the time. It is also responsive in that it can detect changes in patients whose HRQOL has changed and is able to differentiate between stable and unstable patients. Study design Patients and their caregivers attended the clinic at enrollment and after 1. (4) be responsive to change in the caregiver’s quality of life even if that change is small. At the time of enrollment. Four items concern activity limitations and nine concern emotional function. (5) be valid. Paediatric Asthma Quality of Life Questionnaire4.’ We pre-tested the Paediatric Asthma Caregiver’s Quality of Life Questionnaire in a group of 10 caregivers to ensure ease of completion and comprehension. Correlations between the instrument and both conventional clinical asthma measures and generic HRQOL measures were close to predicted for both longitudinal (related to use as an evaluative instrument) and cross-sectional (related to use as a discriminative instrument) validation. We asked 100 primary caregivers to identify which of the 69 items they had experienced in the last year. the caregiver completed three global rating of change questionnaires relating to changes in both the child’s asthma and their own quality of life since their previous visit. 5 and 9 weeks.4 a clinical asthma control questionnaire6 and had spirometry measured before and after a bronchodilator. a literature review and discussion with health professionals. Quality of life outcome measures Paediatric Asthma Caregiver’s Quality of Life Questionnaire. At each visit. i. usually a parent. it is reliable (intraclass correlation coefficient of 0.84). We designed the instrument to meet the following criteria: (1) measure areas of function that are important to the primary 28 Quality of Life Research Vol5 1996 . We have recently developed and tested this questionnaire. both the domain and overah scores range from l-7. the process by which we determined the problems experienced by parents of asthmatic children. all children were symptomatic and had no other illness that had an impact on quality of life. (2) include both physical and emotional impairments. Therefore. in another publication. their response at the prior visit. The Paediatric Asthma Caregiver’s Quality of Life Questionnaire is a self-administered 13 item instrument. a pool of 69 items was generated from unstructured interviews with parents of children with asthma. ’ At each follow-up visit. For each positively identified item. The questionnaire asks caregivers to recall impairments experienced during the previous week taking into account. We have demonstrated that in patients whose HRQOL is stable. at follow-up visits. the children made measurements of peak expiratory flow each morning and completed an asthma symptom and medication diary each morning and evening.
This is a 24item quality of life instrument that evaluates the impact that a child’s illness has on family function.88. we categorized caregivers either as having stayed the same (Group A) or changed (Group B). At bedtime. whether they had produced any sputum and how many puffs of inhaled B-agonist they had used since getting up in the morning. We examined the responsiveness of the Paediatric Asthma Caregiver’s Quality of Life Questionnaire in three ways. we asked caregivers whether they had experienced any change in their overall quality of life. Testing the measurement properties General approach. Classifying caregivers or unchanged as changed Asthma clinical outcome measures There were two study periods (2-5 weeks and 6-9 weeks). mastery (n = 5). on rising each morning and before taking any asthma medication. Initially.’ A discriminative instrument is designed to distinguish between people at a single point in time. For each period. Responses are scored on a 15-point scale from -7 (a very great deal worse) to 0 (no change) to +7 (a very great deal better). we assessed the ability of the instrument to detect within-subject Quality uf Life Research Vol5 1996 29 . (Maximum score = 6. For one week before each clinic visit.60-0. They recorded whether they had been woken during the night by their asthma. Health-related quality of life measurement instruments may have one or more purposes. Evaluative instruments must be responsive (able to detect important within-subject changes.) Caregiver’s perception of child’s asthma At each follow-up clinic visit. family/social (n = 9). they recorded whether they had experienced any limitation in their normal daily activities as a result of their asthma. activity limitations and emotional function). Responses to each item are given on a 4point Likert scale (strongly agree to strongly disagree). we asked caregivers whether there had been any change in their child’s asthma symptoms since the previous visit. They responded on a 1Spoint scale from -7 (a very great deal worse) to 0 (no change) to +7 (a very great deal better). the children made three peak expiratory flow rate measurements and recorded the highest value. financial (n = 4).HRQOL in asthma parents Impact-on-Family Scal$. a pool of 190 potential items was generated through discussion with New York City parents and this was reduced to 24 items by an expert panel and factor analysis.* At each follow-up visit. personal strain (n = 6). The final questionnaire has four domains. At each clinic visit. 0 or +l on the global rating of change questionnaires (overall quality of life. Patients reframed from bronchodilator use for at least 6 hours before each clinic visit. Discriminative instruments require high reliability (high ratio of differences between subjects to difference within subjects) and cross-sectional construct validity (appropriate correlations between established rating scales and the instrument being tested). they were considered to have stayed the same and if they scored between -7 and -2 or between +2 and +7 they were considered to have changed. We measured spirometry before and 20 minutes after two puffs of salbutamol (200 pg). These questionnaires ask about changes in quality of life since the previous clinic visit. First. (3) sputum. whether they had asthma symptoms when they woke in the morning and how many puffs of inhaled P-agonist they used during the night. If caregivers scored -1. even if they are small) and demonstrate longitudinal construct validity (appropriate correlations between changes in the new questionnaire and changes in other measures). (4) limitation of activities and (5) P-agonist use more than four times per day One point was scored if clinic FEVl prebronchodilator was less than 70% predicted. One point is scored for each of the following present on one or more days: (1) awoken by symptoms at night. emotions or activity limitations related to their children’s asthma since their previous clinic visit. Global Rating of Change Questionnaires. (2) awoke with symptoms in the morning.’ We tested both the evaluative and discriminative properties of the Paediatric Asthma Caregiver’s Quality of Life Questionnaire. An evaluative instrument is designed to measure the magnitude of longitudinal change in an individual or group. Internal consistency (Cronbach’s 01)for overall impact and for each domain ranges from 0. an asthma control questionnaire was completed. Evaluative properties.6 This is a composite of asthma symptoms and B-agonist use during the past week (diary) and clinic spirometry.
-2.* From the responsiveness index.0001).0003) but the changes in Group B were also significantly different from the changes in score in the caregivers who reported staying stable (Group A) (p < 0.94.6%) and their ages ranged from 30-63 years (mean 40. For the Table 1. we examined the ability of the instrument to distinguish between subjects who remained stable (Group A) and those who changed (Group B) using an unpaired t-test of the differences between the beginning and end of each period. +2 or +3 on the global rating of change.03 -0.4%) of the caregivers were female and five were male (9.72 (sd = 0. Evaluative properties Twenty-three caregivers contributed 31 sets of observations to the changed category (Group 8) for overall quality of life.” The minimal important difference is the mean difference in score in those who score -3.0001 co. the mean change in overall quality of life score was 1. Twenty-six caregivers contributed 36 observations to the emotional function domains and 17 contributed 22 observations to the activity limitation domain.64) and the activity limitation domain (0.02 -0.72* 0. Third. 1. Second.50 with similar values for the emotional function domain (0. We examined cross-sectional construct validity by correlating caregiver quality of lifescores at each clinic visit with the measures of the child’s asthma severity and with generic caregiver quality of life scores.71. E Juniper et al. We also examined the correlation of changes in quality of life scores with the global ratings of change. We express the variance over 4 weeks as the within-subject standard deviation of change.ooo1 0.01 0. The ratio of the between-subject variance and the total variance has been expressed as an intraclass correlation coefficient. For moderate changes in quality of life (global rating = 4 and 5). Not only were these within-subject changes significant (p < 0. Before analyzing the data. Once again. indices of the child’s clinical asthma severity and the caregiver’s generic quality of life.12 with similar scores in the two domains.E. Results All fifty-two children and their caregivers finished the study and provided complete data sets. sd 5. We used data from caregivers who were stable between consecutive clinic visits (Group A) to determine the reliability of the instrument. We assessed longitudinal construct validity by correlating within-subject changes in the caregiver’s quality of life scores over a four week period with within-subject changes in the child’s health-related quality of life. changes in subjects who changed (Group B) using a paired t-test. symmetry of the data from those who had improved and deteriorated justified our changing the sign in those who deteriorated. Responsiveness: The ability of the questionnaire to detect change Change in caregiver quality of life score** Stable subjects Subjects who changed Difference (A vs. The minimal important difference for overall caregiver quality of life was 0.0003 Domain Overall QOL Emotional function Activity limitation *Within-subject change in score : p c 0. If a caregiver was stable throughout the entire study (periods 1 and 2). For both of these estimations. The mean change in caregiver overall quality of life over a four week period was 0. three clinicians made a priori predictions of where we should expect to find correlations if we were truly measuring quality of life in these caregivers. Fortyseven (90.69) with similar changes in both the emotional function and activity limitation domains (Table 1). The questionnaire took between 3 and 5 minutes to complete. we calculated sample sizes for parallel group and cross-over study designs for various levels of o! and p error rates.001 **Scores are expressed as the change in mean score per item 30 Qualrty of Life Research Vol5 1996 . three clinicians made predictions before the analysis. we calculated a responsiveness index from the minimal important difference and the pooled withinsubject standard deviation from both Groups A and B.67) (Table 2).80* <0. one set of data was randomly selected for analysis. 6) (Group A) (Group 6) p value -0. Discriminarive properties.6 years).
1 p = 0.01 n=80 Global rating of change -3.33* -0.92 n=14 1. global rating of change -1.26 n=4 0.36 -0. t Pearson correlation coefficient Quality of Life Research Vol. *** r > 0.50 n=l6 0. sd = 0.12 n=12 0.63 Table 4.1 p = 0.56 Activities: minimal important difference = 0. Sample sizes for clinical trials Type 1 and type 2 error rates Study design Parallel group: n per group Overall Emotions Activities Cross-over: n of pairs Overall Emotions Activities a = 0. 6 and 7 0. Longitudinal construct validity-f (all subjects) Change in caregiver Emotional function Change in caregiver burden of illness Overall Family/social Personal strain Mastery Change in child’s asthma seventy FEVI % predicted (pre-bd) Peak Expiratory Flow Rate (am) Clinical asthma control P-agonist use Caregiver global ratings of change Emotions Activities Caregiver perception of change in child’s asthma survey A priori predictions: l quality of life Activity limitation -0.05 n=ll -7.05 (one-sided) p = 0.35.12’ 0.41 l -0. ** r = 0.03 0.10’ -0.00 n=2 Table 3.11 0.22’ l 0.35-0.44*** 0.35 -0.50.50 0.31 -0.67 n=9 1.05 21 16 18 11 9 10 26 20 22 14 11 12 a = 0. 4 and 6 0.23* -0. -2.46 0.51 Emotions: minimal important difference = 0. 0 and 1 Change in quality of life score Overall QOL Emotional function Activity limitation -0.67. 2 and 3 -5.5 1996 31 . Change in caregiver’s quality of life scores vs.50.24’ -0. sd = 0.HRQOL in asthma parents Table 2. sd = 0.36 n=3 0. -4.03 n=72 -0.64.02 0.20-0.55*** 0.64 n=l8 0.05 (two-sided) p = 0.02 n=67 -0.0007’ 0.52’ r = 0.38’ -0.05 25 19 22 13 10 12 31 23 26 16 12 14 Based on: Overall: minimal important difference = 0.39 -0. -6.31 0.50 (no star indicates correlations about which we made no a priori predictions).
14 and activity limitation =1. -0.20-0. large changes (global rating=6 and 7). we have calculated the sample sizes required for different a and p error rates in both parallel group and cross-over study designs (Table 3). Reliability of quality of life scores in subjects with stable asthma (Group A) Domain Overall QOL Emotional function Activity limitation Within-subject standard deviation 0.62’ -0.80 0.31 0. ** r > 0. participant contributed to the estimation of reliability.26 0. From these values.31 -0.36 0.E.31 for overall quality of life and the intraclass correlation coefficient was 0. The responsiveness index for overall quality of life was 0.39 Between-subject standard deviation 0.75 0. Similar values were observed for the two domains (Table 5). E Juniper et al. The questionnaire proved highly responsive to within-subject changes over tune with the result that small sample sizes are required to detect changes that are small but considered important by caregivers. we encountered inconsistent changes in score (n=3). Forty-two caregivers contributed 67 observations to the emotional function domains and 46 contributed 80 observations to the activity limitation domain. Discussion The results of this study suggest that the Paediatric Asthma Caregiver’s Quality of Life Questionnaire performs well both as an evaluative instrument for clinical trials and as a discriminative instrument for cross-sectional surveys.25 0.98 (emotional function=1.85 0.26 0.28 r = 0.56* 0.22* -0.88 lntraclass correlation coefficient 0.54 -0.29’* -0. The observed and predicted cross-sectional correlations supporting the discriminative validity of the questionnaire are shown in Table 6.35450.71 0.85. The instrument is also very reproducible with a low within-subject variance that results in a high degree of reliability in being able to detect differences in quality of life between caregivers Discriminative Properties Forty-four caregivers contributed 72 sets of observations to the stable category (Group A) for overall quality of life.30. the within-subject standard deviation of change was 0.07).84 Table 6.50 (no star indicates correlations about which we made no a priori predictions). ** r = 0. Table 4 shows the observed and predicted correlations between changes in the domains of the Paediatric Asthma Caregiver’s Quality of Life Questionnaire and changes in the generic caregiver burden questionnaire and changes in the child’s clinical asthma status.70 0.28* 0. When one set of observations per Table 5.65 -0.56 -0.37 -0.35. t Pearson correlation coefficient 32 Quality of Life Research Vo15 1996 . Cross-sectional construct validityt Caregiver quality of life Emotional function Activity limitation Caregiver burden of illness Overall Family/social Personal strain Mastery Child’s asthma severity FEVI % predicted (pre-bd) Peak Expiratory Flow Rate (am) Clinical asthma control P-agonist use A @on’ predictions: l l -0.
Townsend M. Guyatt GH. Townsend M. J Chron Dis 1985. Jaeschke R. Measuring healthrelated quality of life: Basic Science Review. Med Care 1980. We interpret these results as being consistent with the questionnaire actually measuring changes in caregiver quality of life but reflecting the inadequacy of change in FEVl as a measure of change in asthma severity. Should study subjects see their previous responses? Data from a randomised control trial. Guyatt GH. Juniper EF. 47: 81-87. J Clin Epidemiol 1994. Feeny DH. Norman G. would increase our confidence in its generalizability. 5. Once again. Guyatt GH. 7. Juniper EF. Ferrie PJ. LArcheveque J. Ramsdale EH. Patrick DL. Cartier A. Walter S. the strong reliability and responsiveness of our questionnaire. Griffith LE. 1995: 49-56. Guyatt GH. 11. accepted 25 September 1995) Quality of Life Research Vol 5 1996 33 . 6. d’Aquino C. 10. Measuring change over time: assessing the usefulness of evaluative instruments. Riessman CK. 3. Kline PA. Guyatt GH. ] Clin Epidemioll992. The limitations of our study include the relatively small sample size and our recruitment of a the population from a group of parents familiar with the research process. Determining a minimal important change in a disease-specific quality of life instrument. Juniper EF. 8. Measuring health status: What are the necessarymeasurement properties. 18: 465-472. Evaluation of the burden of illness for pediatric asthmatic patients and their parents. Seip AE. Should we monitor peak expiratory flow rates or record symptoms with a simple diary in the management of asthma? 1 Allergy Chin Immunol 1993. Long-term effect of inhaled corticosteroid (budesonide) on airway hyperresponsiveness and clinical asthma severity in nonsteroid-dependent asthmatics. New York: Raven Press Ltd. Griffith LE. 42: 913-920. Annals Int Med 1993. suggest that investigators interested in measuring the impact of childhood asthma on caregivers can gain important insights through use of the new questioMaire. Stem REK. Feeny DH. In: Spilker B. 9. Testing the questionnaire in other settings. and the same moderate to high correlation (this time higher than we predicted) with parental rating of change in the children’s severity of asthma. with further examination of its validity. Kirshner B. but is it quality of life related to children’s asthma? With respect to its evaluative validity. j C/in Epidemiol 1989. We observed the predicted weak correlations between change in questionnaire score and change in peak flow rates and asthma control but changes in questionnaire score with changes in forced expired volume in one second (FEVI) were lower than predicted. 4. ed. Dolovich J. Guyatt GH. we observed the predicted moderate to high correlation with global ratings of change. 67: 403-408. The high reliability and responsiveness of the instrument confirms we are measuring something. 2. and the supportive evidence of its validity. Guyatt GH. Second Edition. References 1. Townsend M. We interpret these results as suggesting that the specific problems associated with caring for a child with asthma are more closely related to general problems of looking after a sick child than we anticipated. Annals Afkgy 1991. Vanzeileghem MA. Malo JL. Kirshner B. Measuring quality of life in children with asthma. 40: 171-178. Nevertheless. 12. 45: 1341-1345. (Received 23 August 1995. The development of an impacton-family scale: Preliminary findings. 91: 702-709. 142: 832-836. Furlong WJ. Keller JL.HRQOL in astha parents with different degrees of quality of life impairment. Am Rev Respir Dis 1990. Jaeschke R. Willan A. Correlations between asthma severity and questionnaire score were either in the predicted low range or somewhat lower than predicted. Trudeau C. A methodological framework for assessing health indices. How to develop and validate a new quality of life instrument. Guyatt GH.” With respect to its function as a discriminative instrument correlations between the Paediatric Asthma Caregiver’s Quality of Life Questionnaire and the Impact on Family Scale either met or were substantially higher than we predicted. Juniper EF. 70: 225430. 38: 27-36. Feeny DH. Guyatt GH. J Chron Dis 1987. Qua1 Life Res 1996: 5: 35-46. Quality of Life and Pharmacoeconomics in Clinical Trials. these results provide moderate support for the validity of the questionnaire in distinguishing between parents with more and less impairment quality of life as a result of their child’s asthma. Hargreave FE. Singer J. O’Byme PM.
6. how often did you feel helpless or frightened cough. Very Worried or concerned 2. how often did your child’s asthma interfere with your job or work around the house? During the past week. A little worried or concerned 6. how often were you awakened during the night because of your child’s asthma? During the past week. 2. 5. 3. You may only mark one box per question. how often did you feel angry that your child has asthma? During the past week. 10. 3. 12. 7. Please answer each question by placing an x in the appropriate box. how often did you feel frustrated due to asthma? or impatient because your child was irritable During the past week. 5. how often did you feel upset because of your child’s cough. how often were you bothered because your child’s asthma interfered family relationships? with During the past week. 5. Very worried or concerned 3. 7. During the past week. how worried or concerned were you about your child being able to lead a normal life? Response Items Z-9 1. Items 2. Options Items IO-13 1. 9. 9. 6. 8 34 Quality of Lrfe Research Vol 5 1996 . how worried or concerned were you about your child’s asthma medications and side effects? During the past week. 8. 10-13. We want to know about the ways in which your child’s asthma has interfered with your normal daily activities and how this has made you feel. how often did your family need to change plans because of your child’s asthma? During the past week.E. E Juniper et al. 7. 4. 1. or breathlessness? During the past week. Somewhat worried or concerned 5. how worried or concerned were you about being overprotective of your child? During the past week. 11. 2. Not worried or concerned All of the time Most of the time Quit often Some of the time Once in a while Hardly any of the time None of the time Domains Emotional Activities Function Items 1. how worried daily activities? or concerned were you about your child’s performance of normal During the past week. wheeze. wheeze. Paediatric Asthma Caregiver’s Quality of Life Questionnaire This questionnaire is designed to find out how you have been during the last week. Fairly worried or concerned 4. Hardly worried or concerned 7. 6. 3. how often did you have sleepless nights because of your child’s asthma? During the past week. 13. or breathlessness? when your child experienced During the past week. 4. 4. Very.
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