A comparison of two simple measures to evaluate the health status of asthmatics: the Asthma Bother Profile and the Airways Questionnaire 20.

Simple and concise measures for health status are desirable in clinical practice. The Asthma Bother Profile (ABP), which consists of 23 items, has been developed to assess how much asthma bothers patients. The Airways Questionnaire 20 (AQ20) is a simple instrument which consists of 20 items. The purpose of this study was to investigate how the ABP and AQ20 evaluate the health status of patients with asthma. A total of 166 patients with chronic asthma (age: 48 +/- 16 yr, 77 males) completed pulmonary function testing, measurement of airway hyperresponsiveness, dyspnea rating, assessments of their anxiety and depression (HADS; Hospital Anxiety and Depression Scale), and assessments of their health status. The health status was assessed using the ABP, AQ20, the short-form 36 health survey questionnaire (SF-36), the Living With Asthma Questionnaire (LWAQ) and the Asthma Quality of Life Questionnaire (AQLQ). The Japanese version of the ABP included only 15 'bother' items out of the original 23 items due to cultural differences. The scores on the ABP were widely distributed, whereas the scores on the AQ20 were skewed towards the milder end of the scale. The ABP had a strong correlation with the Avoidance and Distress constructs on the LWAQ, and Anxiety and Depression on the HADS (Rs = 0.56 to approximately 0.79), and its strongest correlation with the General Health (Rs = -0.64) scale among the 8 subscales on the SF-36. The AQ20 had a less significant correlation with the LWAQ, AQLQ, and SF-36 than the ABP. The ABP and AQ20 were short and simple to complete, and both measures could easily be used in clinical practice. The ABP can evaluate patients more specifically with respect to distress and bother than the AQ20.     

Comparison of the responsiveness of different disease-specific health status measures in patients with asthma

BACKGROUND: Disease-specific health status measures are characterized by higher responsiveness than generic measures and may be preferred in clinical trials. However, comparisons of responsiveness between various disease-specific measures have rarely been performed in asthma studies. STUDY OBJECTIVE: We investigated and compared the responsiveness of health status scores in asthmatic patients during treatment using three different disease-specific measures: the Juniper Asthma Quality of Life Questionnaire (AQLQ), the Living with Asthma Questionnaire (LWAQ), and the Airways Questionnaire 20 (AQ20). METHODS: We attempted to follow up 170 patients with newly diagnosed asthma over a 6-month period. Patients underwent treatment with inhaled corticosteroids in accordance with the guideline. A health status evaluation using three disease-specific measures, and pulmonary function tests were performed on the initial visit, and at 3 months and 6 months. The effect size and the standardized response mean were used as responsiveness indexes. RESULTS: A total of 109 patients completed the 6-month follow-up and were then analyzed. All health status scores and FEV(1) measures improved during the first 3 months (p < 0.001). The total of the AQLQ scores showed high responsiveness indexes ranging from 1.28 to 1.46 between baseline and 3 months, and baseline and 6 months. Spearman correlation coefficients were smaller between the change in FEV(1) and the change in the LWAQ. Although the AQ20 also demonstrated high responsiveness, a ceiling effect was indicated. CONCLUSIONS: The AQLQ was the most responsive measure during asthma treatment. The relationship between the change in airflow limitation and the change in the LWAQ was weaker compared to the AQLQ and the AQ20. Although the AQ20 was also responsive and its simplicity is favorable, the ceiling effect should be considered when using it.     

Health-Related Quality of Life in Stable Asthma: What Are Remaining Quality of Life Problems in Patients with Well-Controlled Asthma?

We purposed to examine the distribution of the disturbances in the health-related quality of life (HRQoL) and to determine the relationship between HRQoL and various clinical parameters in patients with well-controlled asthma according to the guidelines. We enrolled 162 patients with stable asthma, and 113 were defined as well-controlled. HRQoL was measured by the Living with Asthma Questionnaire (LWAQ), the St. George's Respiratory Questionnaire (SGRQ), and the short-form 36 health survey questionnaire (SF-36), dyspnea by the Medical Research Council (MRC), and psychological status by the Hospital Anxiety and Depression Scale (HADS). In both stable and well-controlled patients, the frequency distributions showed that the scores on the Avoidance, Distress, and Preoccupation constructs on the LWAQ were widely distributed, whereas the scores on the Vitality and General Health scales on the SF-36 were normally distributed. In patients with well-controlled asthma, the HADS had mild to moderate correlations with all questionnaires. Multiple regression analysis showed that the Anxiety, the MRC scale and the treatment steps accounted for 44% of the variance in the Avoidance on the LWAQ. These results suggest that domains of psychological well-being may continue to be affected even though the asthma patients are well-controlled by guideline criteria.     

Health-related quality of life in stable asthma: what are remaining quality of life problems in patients with well-controlled asthma?

We purposed to examine the distribution of the disturbances in the health-related quality of life (HRQoL) and to determine the relationship between HRQoL and various clinical parameters in patients with well-controlled asthma according to the guidelines. We enrolled 162 patients with stable asthma, and 113 were defined as well-controlled. HRQoL was measured by the Living with Asthma Questionnaire (LWAQ), the St. George's Respiratory Questionnaire (SGRQ), and the short-form 36 health survey questionnaire (SF-36), dyspnea by the Medical Research Council (MRC), and psychological status by the Hospital Anxiety and Depression Scale (HADS). In both stable and well-controlled patients, the frequency distributions showed that the scores on the Avoidance, Distress, and Preoccupation constructs on the LWAQ were widely distributed, whereas the scores on the Vitality and General Health scales on the SF-36 were normally distributed. In patients with well-controlled asthma, the HADS had mild to moderate correlations with all questionnaires. Multiple regression analysis showed that the Anxiety, the MRC scale and the treatment steps accounted for 44% of the variance in the Avoidance on the LWAQ. These results suggest that domains of psychological well-being may continue to be affected even though the asthma patients are well-controlled by guideline criteria.     

Comparison of the standard gamble, rating scale, AQLQ and SF-36 for measuring quality of life in asthma.

With interest in health economics growing, there is a demand for valid methods for measuring health-related quality of life (HRQL) in asthma using utilities. The aims of this study were to develop disease-specific versions of the standard gamble and rating scale, to compare their measurement properties with those of the Asthma Quality of Life Questionnaire (AQLQ) and the Medical Outcomes Survey Short-Form 36 (SF-36), as well as to determine their validity for assessing asthma-specific quality of life. Forty adults with symptomatic asthma participated in a 9-week observational study. Participants completed the standard gamble, rating scale, AQLQ, SF-36 and other measures of clinical asthma status at baseline and after 1, 5 and 9 weeks. In patients whose asthma was stable between assessments, reliability was good for the rating scale (intraclass correlation coefficient (ICC)=0.89) and the AQLQ (ICC=0.95) but more modest for the SF-36 mental score (ICC=0.68), SF-36 physical score (ICC=0.65) and standard gamble (ICC=0.59). The responsiveness index was highest in the AQLQ (1.35), followed by the rating scale (0.74), the physical score of the SF-36 (0.61) and the standard gamble (0.31). Construct validity (correlation with other indices of health status) was strongest for the AQLQ and the rating scale. In conclusion, both the disease-specific rating scale and the Asthma Quality of Life Questionnaire have strong measurement properties for measuring asthma-specific quality of life; the Short-Form 36 health survey physical summary score has more modest properties. Although the disease-specific standard gamble has acceptable discriminative properties, its evaluative properties are too inadequate for it to be used in cost/utility analyses. Poor correlation between the standard gamble and the rating scale indicates that utilities cannot be derived from rating scale data.     

Analysis of longitudinal changes in the psychological status of patients with asthma

Significant relationships between the psychological status and poor asthma outcomes are often reported. However, most of these studies are cross-sectional and none have evaluated how the psychological status progresses over time during the management of asthma patients. Therefore, we examined the longitudinal changes in the psychological status of asthma patients, and compared them with changes in other clinical measurements. Eighty-seven outpatients with stable asthma after 6 months of treatment were enrolled in this study. The psychological status was evaluated using the Hospital Anxiety and Depression Scale (HADS), the health status using the Asthma Quality of Life Questionnaire (AQLQ) and the St. George's Respiratory Questionnaire (SGRQ). The patient's pulmonary function, peak expiratory flow values and airway hyperresponsiveness were measured at entry and every year thereafter over a 5-year period. Using mixed effects models to estimate the slopes, the HADS anxiety and depression scores did not change significantly over time (p=0.71 and 0.72, respectively). The changes in the HADS scores correlated noticeably with changes in the AQLQ and SGRQ scores, but not with changes in the physiological measurements. The baseline HADS anxiety and depression scores were significantly correlated to the subsequent annual changes in each measurement. The psychological status remained clinically stable over the 5-year study period in patients with stable asthma. Changes in the psychological status were significantly correlated to changes in the health status. The baseline HADS scores were a useful indicator in detecting patients who would show subsequent deterioration in their psychological status.     

Perceived Control and Quality of Life in Asthma: Impact of Asthma Education

The purpose of this study was to determine the relationship between patients' perception of asthma control and generic and asthma-specific quality of life (QOL) post-completion of a behavior modification-based adult asthma education program. A secondary objective was to examine associations between changes in perceived control of asthma and generic and asthma-specific QOL. Outcome measures were collected via an asthma management questionnaire (AMQ), generic (SF-36) and asthma-specific (AQLQ) QOL questionnaires, and a perceived control of asthma questionnaire (PCAQ). The cohort (n = 55) consisted of predominately female (75%), married (56%), middle income (46%) patients with severe asthma (65%) who had completed a university or college education (20%) and were working full-time (42%). The mean age was 45.2 (SD = 17.5) years. Perceived control of asthma and generic and asthma-specific quality of life significantly improved after completing the behavior modification-based adult asthma education program. Significant associations were found between perceived control of asthma (PCAQ) and both generic (SF-36) and asthma-specific QOL (AQLQ). Baseline PCAQ was related to all four domains and the total score of the AQLQ and 5 of the 8 domains of the SF-36. PCAQ was related to 3 of the 4 AQLQ domains at 3 months and total AQLQ score at both 1 and 3 months post-education. PCAQ was related to all 8 domains of the SF-36 at 1 month; and 4 of 8 domains at 3 months. Change in PCAQ (ΔPCAQ) was related to change in symptom score, emotional functioning, and total AQLQ score from baseline to 1 month and change in symptom score from baseline to 3 months. In conclusion, perceived control of asthma in patients participating in a behavior modification-based asthma education program was related to generic and disease-specific QOL. An improvement in PCAQ was associated with improved QOL following asthma education. Using the PCAQ as part of an asthma educational needs assessment may be a quick, simple way to identify and target education towards asthma patients with low perceived control.     

Quality of Life in Asthmatic Outpatients

Asthma patients incur a great cost in terms of loss of quality of life. The purpose of this study is to evaluate the relative contribution and relationship of several patient- and disease-related factors, measured by several variables, to the quality of life in adults with asthma. Two hundred and ten asthmatic outpatients over 18 years old, registered in a Family Health Unit, were randomly selected to complete the Asthma Quality of Life (AQLQ) and Short Form Generic questionnaires (SF-36), respectively. Single and multiple linear regression models were developed to explain the variability of the summary scores of AQLQ and Physical and Mental Health SF-36. As potential predictors, the following independent variables were used: gender, age, number of comorbidities, asthma severity following the Global Initiative for Asthma (GINA) criteria, asthma control (measured by ACQ questionnaire), %FEV₁ (forced expiratory volume in the first second) and, for the first time, Graffar Score to assess socioeconomical features. The Graffar Score is an index that divides the population in 5 socioeconomic layers. We report the best Adjusted R Square of these models published in the literature, ranging from 0.40 to 0.76. Women showed poorer quality of life than men. The best predictor of AQLQ was ACQ, followed by Asthma Severity, Gender and %FEV₁. The best predictors of Physical and Mental Health SF-36 were, by decreasing importance, ACQ, number of comorbidities, Gender and Graffar Score. We note that the variable number of comorbidities was included in both SF-36 models, but not in AQLQ model. Asthma Severity and %FEV₁ did not enter into SF-36 models. We conclude that besides clinical and functional measures, the evaluation process of the overall health status must incorporate quality-of-life measures.     

Quality of Life in Asthmatic Outpatients

Asthma patients incur a great cost in terms of loss of quality of life. The purpose of this study is to evaluate the relative contribution and relationship of several patient- and disease-related factors, measured by several variables, to the quality of life in adults with asthma. Two hundred and ten asthmatic outpatients over 18 years old, registered in a Family Health Unit, were randomly selected to complete the Asthma Quality of Life (AQLQ) and Short Form Generic questionnaires (SF-36), respectively. Single and multiple linear regression models were developed to explain the variability of the summary scores of AQLQ and Physical and Mental Health SF-36. As potential predictors, the following independent variables were used: gender, age, number of comorbidities, asthma severity following the Global Initiative for Asthma (GINA) criteria, asthma control (measured by ACQ questionnaire), %FEV₁ (forced expiratory volume in the first second) and, for the first time, Graffar Score to assess socioeconomical features. The Graffar Score is an index that divides the population in 5 socioeconomic layers. We report the best Adjusted R Square of these models published in the literature, ranging from 0.40 to 0.76. Women showed poorer quality of life than men. The best predictor of AQLQ was ACQ, followed by Asthma Severity, Gender and %FEV₁. The best predictors of Physical and Mental Health SF-36 were, by decreasing importance, ACQ, number of comorbidities, Gender and Graffar Score. We note that the variable number of comorbidities was included in both SF-36 models, but not in AQLQ model. Asthma Severity and %FEV₁ did not enter into SF-36 models. We conclude that besides clinical and functional measures, the evaluation process of the overall health status must incorporate quality-of-life measures.     

Patient-assessed measures of health outcome in asthma: a comparison of four approaches

The study compares the psychometric properties of four different approaches to patient-assessed health outcomes in asthma, including the Asthma Quality of Life Questionnaire (AQLQ), Newcastle Asthma Symptoms Questionnaire (NASQ), SF-12 and EuroQol. The instruments were administered by means of a self-completed postal questionnaire to 394 patients recruited from general practices in the North East of England. Patients completed a follow-up questionnaire at 6 months. The levels of missing data were assessed and instrument scores compared using correlational analysis. Scores were related to self-reports of smoking behaviour, socioeconomic status and health transition. Responsiveness was assessed using standardized response means. Two hundred and thirty-five patients took part in the study giving a response rate of 59.6%. There was a relatively large amount of missing data for the individualized section of the AQLQ. Correlational analysis provided evidence of convergent validity between the specific instruments; the largest correlation was found between NASQ scores and the asthma symptoms scale of the AQLQ (r = 0.84). The NASQ was found to be the most powerful at discriminating between smokers and non-smokers. All four instruments were linearly related to self-reported asthma transition (P<0.05); the specific instruments having the strongest association. The specific instruments showed good levels of responsiveness with the NASQ producing a large SRM of 0.82. SRMs for the AQLQ were of a moderate to large size (0.32-0.77) and the SRMs for the SF-12 and EuroQol were of a small size. The two specific instruments are capable of greater levels of discrimination between groups of patients and are more responsive to changes in health than the generic SF-12 and EuroQol. The greater responsiveness of the NASQ is probably due to its focus being restricted to symptoms of asthma compared to the broader focus of the AQLQ domains. The NASQ has a strong relationship with the AQLQ and is a more practical instrument that is more acceptable to patients. However, the AQLQ does measure broader patient concerns. The SF-12 and EuroQol have greater potential to capture side-effects and have wider scope for application in economic evaluation.     

Development and validation of the Mini Asthma Quality of Life Questionnaire.

The 32-item Asthma Quality of Life Questionnaire (AQLQ) has shown good responsiveness, reliability and construct validity; properties that are essential for use in clinical trials, clinical practice and surveys. However, to meet the needs of large clinical trials and long-term monitoring, where efficiency may take precedent over precision of measurement, the 15-item self-administered MiniAQLQ has been developed. The MiniAQLQ was tested in a 9-week observational study of 40 adults with symptomatic asthma. Patients completed the MiniAQLQ, the AQLQ, the Short Form (SF)-36, the Asthma Control Questionnaire and spirometry at baseline, 1, 5 and 9 weeks. In patients whose asthma was stable between clinic visits, reliability was very acceptable for the MiniAQLQ (intraclass correlation coefficient (ICC)=0.83), but not quite as good as for the AQLQ (ICC=0.95). Similarly, responsiveness in the MiniAQLQ (p=0.0007) was good but not quite so good as for the AQLQ (p<0.0001). Construct validity (correlation with other indices of health status) was strong for both the MiniAQLQ and the AQLQ. Criterion validity showed that there was no bias between the instruments (p=0.61) and the correlation between them was high (r=0.90). The Mini Asthma Quality of Life Questionnaire has good measurement properties but they are not quite as strong as those of the original Asthma Quality of Life Questionnaire. The choice of questionnaire should depend on the task at hand.     

Validation of a standardized version of the Asthma Quality of Life Questionnaire.

BACKGROUND: In the original 32-item Asthma Quality of Life Questionnaire (AQLQ), five activity questions are selected by patients themselves. However, for long-term studies and large clinical trials, generic activities may be more appropriate. METHODS: For the standardized version of the AQLQ, the AQLQ(S), we formulated five generic activities (strenuous exercise, moderate exercise, work-related activities, social activities, and sleep) to replace the five patient-specific activities in the AQLQ. In a 9-week observational study, we compared the AQLQ with the AQLQ(S) and examined their measurement properties. Forty symptomatic adult asthma patients completed the AQLQ(S), the AQLQ, the Medical Outcomes Survey Short Form 36, the Asthma Control Questionnaire, and spirometry at baseline, 1, 5, and 9 weeks. RESULTS: Activity domain scores (mean +/- SD) were lower with the AQLQ (5.7 +/- 0.9) than with the AQLQ(S) (5.9 +/- 0.8; p = 0.0003) and correlation between the two was moderate (r = 0.77). However, for overall scores, there was minimal difference (AQLQ, 5.4 +/- 0.8; AQLQ(S), 5.5 +/- 0.8; r = 0.99). Reliability (AQLQ intraclass correlation coefficient, 0.95; AQLQ(S) intraclass correlation coefficient, 0.96) and responsiveness (AQLQ, p < 0.0001; AQLQ(S), p < 0.0001) were similar for the two instruments. Construct validity (correlation with other measures of health status and clinical asthma) was also similar for the two instruments. CONCLUSIONS: The AQLQ(S) has strong measurement properties and is valid for measuring health-related quality of life in asthma. The choice of instrument should depend on the task at hand.     

Brief questionnaires for patient-reported outcomes in asthma: validation and usefulness in a primary care setting

STUDY OBJECTIVES AND DESIGN: Health-related quality of life (QoL) instruments are generally used for studies of asthma in specialized settings. For primary care use, there is a need for brief and simple questionnaires for structured patient-reported outcomes. We validated the Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ), using the Asthma Quality of Life Questionnaire with standardized activities (AQLQ[S]) as the "gold standard." The Asthma Control Questionnaire (ACQ) was validated against the symptoms domain of the AQLQ(S). Patients were characterized by the Short Form-36 Health Survey (SF-36). SUBJECTS: One hundred eight patients (68 women) with asthma diagnosed by their physicians from 24 primary care centers completed two visits (2 to 3 months apart). Their mean SF-36 scores were lower than the national norm for all domains. RESULTS: The Mini-AQLQ and ACQ correlated well with the AQLQ(S). Reliability, determined in 57 patients with stable AQLQ(S) scores, was good. Both brief questionnaires detected improvement or deterioration of patients at the group level. Global ratings of disease severity by patients or clinicians correlated poorly with disease-specific QoL scores. CONCLUSIONS: The Mini-AQLQ and ACQ instruments are sufficiently simple and robust to be suitable for research and quality of care monitoring in primary care at the group level. They may, after further validation, even be useful in the management of individual patients.     

Measuring health-related quality of life in adults during an acute asthma exacerbation

BACKGROUND: Acute severe asthma can be distressing for patients. It is important to be able to identify the causes of the distress so that these can receive attention in conjunction with the conventional treatment of the airways. STUDY OBJECTIVE: To modify the Asthma Quality of Life Questionnaire (AQLQ) for evaluating patients with acute severe asthma and to test the measurement properties of the Acute Asthma Quality of Life Questionnaire (Acute AQLQ). METHODS: The Acute AQLQ contains the symptom and emotional function items of the AQLQ (n = 11), which are capable of changing over short periods of time. The measurement properties were tested during a clinical trial to compare formoterol and salbutamol in the treatment of acute severe asthma in hospital emergency departments. RESULTS: The 88 patients in the clinical trial provided evidence that the Acute AQLQ has high internal consistency (Cronbach alpha = 0.90) and is very responsive to change in status (p < 0.00001) with a responsiveness index of 2.5. Correlations between the Acute AQLQ and other measures of clinical status provided evidence of the validity of the instrument. CONCLUSION: The Acute AQLQ has strong measurement properties and can be used with confidence to identify the problems that are distressing to patients during an acute asthma exacerbation and to evaluate the effectiveness of interventions.     

Validity and reliability of "Asthma Quality of Life Questionnaire" in a sample of Turkish adult asthmatic patients

We aimed to investigate the validity and reliability and of "Asthma Quality of Life Questionnaire (AQLQ)" in Turkish adult asthmatic patients. New or previously diagnosed [according to Global Initiative for Asthma (GINA) 2008] symptomatic 118 consecutive stable asthmatic patients between 18 and 55 years old were included. Asthma severity was determined and Turkish adaptation of the AQLQ was administered. Lara asthma symptom scales (LASS), pulmonary function tests, Turkish adaptation of Medical Outcomes Survey Short Form-36 (SF-36) were evaluated. All assessments were done twice at recruitment and after 10 weeks. During this period patients were allowed to make modifications on their medication when necessary. Among the recruited 118 patients 95 were female and 14 were lost in the follow-up. Sixty-two percentages of the patients had mild and 38% moderate asthma. The internal consistency of AQLQ was high (Cronbach's alpha 0.81-0.87) and item-total score correlations were ranging from 0.75-0.89. The cross-sectional and longitudinal correlations between AQLQ total and domain scores and SF36 domain scores were in a range of little or fair degree (r= 0.241-0.626, p< 0.005). Total AQLQ scores were observed significantly different according to disease severity and LASS both in the first (p< 0.001, both) and 10 weeks follow-up visits (p= 0.006, p< 0.001 respectively). A statistical significant change was observed in AQLQ symptom score as in total LASS changed (p< 0.001, both) in the follow-up. Our results demonstrated that Turkish version of AQLQ is feasible, reliable, valid and sensitive to changes in adult asthmatics.     

Effects of depressive symptoms on health-related quality of life in asthma patients

OBJECTIVE: To assess the effects of depressive symptoms on asthma patients’ reports of functional status and health-related quality of life. DESIGN: Cross-sectional study. SETTING: Primary care internal medicine practice at a tertiary care center in New York City. PATIENTS: We studied 230 outpatients between the ages of 18 and 62 years with moderate asthma. MEASUREMENTS AND MAIN RESULTS: Patients were interviewed in person in English or Spanish with two health-related quality-of-life measures, the disease-specific Asthma Quality of Life Questionnaire (AQLQ) (possible score range, 1 to 7; higher scores reflect better function) and the generic Medical Outcomes Study SF-36 (general population mean is 50 for both the Physical Component Summary [PCS] score and Mental Component Summary [MCS] score). Patients also completed a screen for depressive symptoms, the Geriatric Depression Scale (GDS), and a global question regarding current disease activity. Stepwise multivariate analyses were conducted with the AQLQ and SF-36 scores as the dependent variables and depressive symptoms, comorbidity, asthma, and demographic characteristics as independent variables. The mean age of patients was 41 ± SD 11 years and 83% were women. The mean GDS score was 11 ± SD 8 (possible range, 0 to 30; higher scores reflect more depressive symptoms), and a large percentage of patients, 45%, scored above the threshold considered positive for depression screening. Compared with patients with a negative screen for depressive symptoms, patients with a positive screen had worse composite AQLQ scores (3.9±SD 1.3 vs 2.8±SD 0.8, P<.0001) and worse PCS scores (40±SD 11 vs 34±SD 8, P<.0001) and worse MCS scores (48±SD 11 vs 32±SD 10, P<.0001) scores. In stepwise analyses, current asthma activity and GDS scores had the greatest effects on patient-reported health-related quality of life, accounting for 36% and 11% of the variance, respectively, for the composite AQLQ, and 11% and 38% of the variance, respectively, for the MCS in multivariate analyses. CONCLUSIONS: Nearly half of asthma patients in this study had a positive screen for depressive symptoms. Asthma patients with more depressive symptoms reported worse health-related quality of life than asthma patients with similar disease activity but fewer depressive symptoms. Given the new emphasis on functional status and health-related quality of life measured by disease-specific and general health scales, we conclude that psychological status indicators should also be considered when patient-derived measures are used to assess outcomes in asthma. This project was supported by a Robert Wood Johnson Foundation Generalist Physician Faculty Scholar’s Award to Dr. Mancuso.     

A health-related quality-of-life comparison of formoterol (Oxis) Turbuhaler plus budesonide (Pulmicort) Turbuhaler with budesonide Turbuhaler alone and noncorticosteroid treatment in asthma: a randomized clinical study in Russia

BACKGROUND: In Russia, current therapy for the long-term management of asthma is mainly nonsteroidal. This situation provides the opportunity to evaluate new asthma treatments in a patient cohort with little previous exposure to inhaled corticosteroids. OBJECTIVES: To compare the effect of formoterol (Oxis) Turbuhaler plus budesonide (Pulmicort) Turbuhaler with budesonide Turbuhaler alone, on the health-related quality of life (HRQL) of patients with mild to moderate asthma. METHODS: A double-blind, parallel-group, randomized, 12-week study compared formoterol Turbuhaler plus budesonide Turbuhaler and budesonide Turbuhaler alone with an open control group of the investigator's choice of noncorticosteroid therapy. Patients completed the Short Form 36 (SF-36) and the Asthma Quality of Life Questionnaire (AQLQ). RESULTS: The improvement in HRQL scores for patients treated with noncorticosteroids was significantly less (p < 0.05) than those treated with formoterol plus budesonide and budesonide alone in all domains of the SF-36 and AQLQ with one marginal exception (budesonide versus investigator's choice, SF-36, Mental Component Scale, p = 0.053). Improvements in HRQL scores of formoterol plus budesonide, compared with budesonide alone, although generally higher, were not significantly different. Formoterol plus budesonide was more effective in improving lung function and reducing both symptoms and the need for relief terbutaline inhalation. CONCLUSION: Formoterol Turbuhaler plus budesonide Turbuhaler and budesonide Turbuhaler alone significantly improved the HRQL of patients with mild to moderate asthma compared with noncorticosteroid treatment.     

A comparison of global questions versus health status questionnaires as measures of the severity and impact of asthma.

This study compared estimates of the severity and impact of asthma recorded using global questions of the type used in diary cards with health status measurements obtained using comprehensive questionnaires. Seventy-four outpatients with asthma, aged 17-76 yrs (mean 48 yrs) participated. Mean+/-SD forced expiratory volume in one second (FEV1) was 72+/-26% predicted. Patients recorded morning and evening peak expiratory flow rate (PEFR) and scaled their responses to the questions: "How has your asthma been today?" (asthma severity) and "How much effect has your asthma had on your life today?" (asthma impact) for 2 weeks. They then completed Juniper's Asthma Quality of Life Questionnaire (AQLQ) and the St George's Respiratory Questionnaire (SGRQ). Diary card scores for asthma impact were less severe than for asthma severity (p<0.0001). Both correlated with AQLQ and SGRQ total scores (r>0.7; p<0.0001). Some patients responded 'none' for asthma severity (n=10) or asthma impact (n=13) on all 14 days of recording. For these patients, FEV1 was <80% predicted, morning PEFR was <90% predicted and their AQLQ and SGRQ scores indicated significant health impairment. Diary card scores for asthma severity and impact were correlated with health status, but these global questions were insensitive in mild disease. Responses to these questions were influenced by their wording, so the number of symptom-free days calculated from diary cards will depend on the questions used. Standardization is required before symptom-free days can be used as a reliable measure of treatment efficacy.     

Improvement in health-related quality of life with fluticasone propionate compared with budesonide or beclomethasone dipropionate in adults with severe asthma

OBJECTIVE: Changes in health-related quality of life (HRQoL) were evaluated in adults with severe asthma following inhaled corticosteroid treatment with high-dose beclomethasone dipropionate or budesonide (BDP/BUD) and compared with fluticasone propionate taken at approximately half the dose of BDP/BUD. METHODOLOGY: HRQoL was assessed as part of an open, multicentre, randomized, parallel-group study in Australia evaluating the safety and efficacy of switching to fluticasone propionate (FP) 1000-2000 micro g/day (n = 67) compared with remaining on BDP/BUD >/=1750 micro g/day (n = 66) for 6 months. Patients completed two HRQoL questionnaires, the Asthma Quality of Life Questionnaire (AQLQ) and the Medical Outcomes Study Short Form-36 (SF-36), at baseline and at weeks 12 and 24. A change in AQLQ score of >/=0.5 was considered to be clinically meaningful. RESULTS: There were significant improvements in HRQoL with FP on four of the eight dimensions on the SF-36 (i.e. physical functioning, general health, role-emotional, and mental health), while there were no significant improvements in HRQoL in the BDP/BUD group. Overall, patients in the FP group experienced significantly greater improvement (P < 0.001) in AQLQ scores at weeks 12 and 24 compared with the BDP/BUD group. On the individual domains of the AQLQ, there were significant treatment differences (P < 0.01) in favour of FP in three of the four domains (activity limitations [0.92], symptoms [0.73], and emotional function [1.02]). Mean differences between groups for overall score and these three domains were also clinically meaningful. CONCLUSION: Patients with severe asthma who received FP (at approximately half the dose of BDP/BUD) experienced statistically significant, as well as clinically meaningful, improvements in their HRQoL.     

Relationship between patient and disease characteristics,and health-related quality of life in adults with asthma

The purpose of this study was to examine relationships between patient- and disease-related variables and health-related quality of life (HQL). This cross-sectional study surveyed adults with asthma enrolled in a managed care organization (MCO). Data were obtained from a mailed questionnaire and the MCO's patient and claims databases. The Asthma Quality of Life Questionnaire (AQLQ) and the SF-36 instruments were used. The behavioral Model of Health Services Utilization was used to characterize independent variables and their relationships to HQL. Independent variables included predisposing (age, gender, education, race, number of comorbidities, years with asthma, social support, health-belief questions); enabling (income, number of metered dose inhaler (MDI) instructors, perceived inconvenience of accessing the physician); and illness level (perceived and symptom-derived asthma severity). Multivariate linear regression models were developed to examine the relationships between the independent variables and the domain and summary scores of the AQLQ and the SF-36. The survey response rate was 63% (n=603). for the AQLQ, symptom-derived severity perceived severity education level, and the health-belief factor Barriers were significant in all five models. Symptom-derived severity had consistently higher standardized regression coefficients than perceived severity Barriers had the highest coefficient in all but the Symptoms domain model. Number of Comorbidities was significant in all eight domain and two summary score SF-36 models. Symptom-derived and/or perceived severity were also significant in all but the Mental Health domain model. Other frequently significant variables included the health-belief factor Barriers and Yearly Household Income. When assessing HQL of a population, such as this group of patients with asthma, one must consider patient and disease variables that may influence the results.