Klas Svensson

Health-related quality of life is related to COPD disease severity

BackgroundThe aim of this study was to evaluate the association between health-related quality of life (HRQL) and disease severity using lung function measures.MethodsA survey was performed in subjects with COPD in Sweden. 168 subjects (70 women, mean age 64.3 years) completed the generic HRQL questionnaire, the Short Form 36 (SF-36), the disease-specific HRQL questionnaire; the St Georges Respiratory Questionnaire (SGRQ), and the utility measure, the EQ-5D. The subjects were divided into four severity groups according to FEV1 per cent of predicted normal using two clinical guidelines: GOLD and BTS. Age, gender, smoking status and socio-economic group were regarded as confounders.ResultsThe COPD severity grades affected the SGRQ Total scores, varying from 25 to 53 (GOLD p = 0.0005) and from 25 to 45 (BTS p = 0.0023). The scores for SF-36 Physical were significantly associated with COPD severity (GOLD p = 0.0059, BTS p = 0.032). No significant association were noticed for the SF-36, Mental Component Summary scores and COPD severity. Scores for EQ-5D VAS varied from 73 to 37 (GOLD I-IV p = 0.0001) and from 73 to 50 (BTS 0-III p = 0.0007). The SGRQ Total score was significant between age groups (p = 0.0047). No significant differences in HRQL with regard to gender, smoking status or socio-economic group were noticed.ConclusionThe results show that HRQL in COPD deteriorates with disease severity and with age. These data show a relationship between HRQL and disease severity obtained by lung function.

Asthma quality of life during 1 year of treatment with budesonide with or without formoterol

The Formoterol and Corticosteroids Establishing Therapy (FACET) study has provided the first opportunity to examine the long-term effects of inhaled steroids and long-acting beta2-agonists on asthma-specific quality of life. The objectives of the present study were to: evaluate the effects of long-term (1 yr) formoterol and increasing doses of budesonide on asthma quality of life; 2) to determine whether initial improvements in quality of life are sustained when improvements in clinical indices persist; and 3) to evaluate the long-term relationship between changes in clinical indices and changes in quality of life. Of the 852 asthmatic adults enrolled, 470 from five countries participated in this quality of life evaluation. After a 4-week run-in on 1,600 microg budesonide, patients were randomized to either 200 microg (Bud200) or 800 microg budesonide (Bud800) in combination with either 24 microg formoterol (F) or placebo daily for 1 yr. The Asthma Quality of Life Questionnaire (AQLQ) was completed and conventional clinical indices measured at enrolment and randomization and on seven occasions during the following 12 months. During the run-in, there was an improvement in AQLQ score (changes (delta) in overall score approximately 0.50; p<0.0001). After randomization, there was a further improvement in the Bud800+F group (delta=0.21; p=0.028). One month post-randomization, improvements in all groups stabilized and were sustained throughout the 12 months in a pattern very similar to that observed for the conventional clinical indices. The correlation of individual patient changes in clinical indices and changes in AQLQ score during the 12-month randomized period were weak to moderate (maximum r=0.51). Improvements in quality of life, which were greatest in the 800 microg budesonide plus 24 microg formoterol group, were sustained throughout the 12 months in a similar manner to the clinical indices. Long-term changes in conventional clinical indices cannot be used to predict the effect of treatment on individual patient experience.

Psychometric and utility-based measures of health status of asthmatic patients with different disease control level

AbstractObjective: To explore the relationship between asthma control level and healthrelated QOL (HR-QOL), and to understand the role of various psychometric and utility-based methods in studying this relationship. Methods: Two hundred and twenty-eight consecutive adult outpatients and inpatients at four sites participated in the study. Physicians identified the level of disease control according to the Global Initiative for Asthma (GINA) classification system. Patients filled in three different HR-QOL questionnaires (EuroQol 5-D [EQ-5D], Short-Form 36-item health survey [SF-36], and St George’s Respiratory Questionnaire [SGRQ]) and a direct time trade-off question. The Short Form- 6D (SF-6D) was used to derive utility values from SF-36 data. Results: All patient-reported evaluation methods could discriminate between patients with different disease control levels, and both generic and diseasespecific instruments strongly correlated to each other. The magnitude of differences in HR-QOL between groups with different disease control levels was clinically meaningful. All three HR-QOL measures reflected a relationship between disease control level and HR-QOL, but the actual pattern of the relationship depended on the instrument used. Utilities gained from the EQ-5D index, compared with the SF-6D index, had higher values in the patient group with the best disease control and lower values in the patient group with poor disease control. Conclusions: When choosing an instrument to measure the health status of asthmatic patients in clinical studies, the severity range of the study population should be considered. Researchers might prefer to use the EQ-5D in asthma patients with severe disease or poor disease control and the SF-6D in patients with mild disease or good disease control.

Modification of the asthma quality of life questionnaire (standardised) for patients 12 years and older

BackgroundThe age limit for some adult asthma clinical trials has recently been lowered to 12 years. In this study we have made minor modifications to the standardised version of the adult Asthma Quality of Life Questionnaire (AQLQ(S)) to make it valid for patients 12 years and older (AQLQ12+).MethodsWe have used two clinical trial databases, in which the AQLQ12+ was used, to compare the measurement properties of the questionnaire in patients 12–17 years and patients 18 years and older. A total of 2433 patients (12–75 years), with current asthma and with data that could be evaluated both at randomisation and end of treatment, were included.ResultsThe analysis showed that internal consistency, responsiveness and correlations with other clinical indices were very similar in patients 12–17 years and patients 18 years and older.ConclusionThe measurement properties of the AQLQ12+ are similar in adolescents and adults and therefore the instrument is valid for use in adult studies which include children 12 years and older.

Cost effectiveness of budesonide/formoterol in a single inhaler for COPD compared with each monocomponent used alone

AbstractObjective: To compare the healthcare costs and effects of budesonide/formoterol in a single inhaler with those of budesonide and formoterol monotherapies, and placebo, in a multinational study in patients with chronic obstructive pulmonary disease (COPD), National Heart, Lung and Blood Institute (NHLBI)/WHO Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages III or IV. Previous analysis of the clinical data from the study had shown that budesonide/formoterol was associated with better lung function and improved health-related QOL compared with the monocomponents or placebo and lower frequency of exacerbations compared with formoterol and placebo. Method: Patients (n = 1022) were randomised to twice-daily treatment with two inhalations of budesonide/formoterol (160μg/4.5μg) in a single inhaler, budesonide 200μg, formoterol 4.5μg or placebo for 12 months. Data on medication and healthcare use were combined with Swedish unit cost data to estimate the total annual healthcare cost per patient from the Swedish healthcare payer perspective. Costs were valued in Swedish kronor (SEK) [2001 values] and converted to euros (SEK1 = €0.11, 25th April 2003). Results: This evaluation estimated the total annual healthcare costs per patient to be numerically lower for budesonide/formoterol (€2518) than for budesonide (€3194), formoterol (€3653) or placebo (€3213). Cost-effectiveness acceptability curves suggest that budesonide/formoterol may be cost effective compared with formoterol, even if the decision maker is not willing to pay anything for the additional clinical effects, and that budesonide/formoterol is cost effective compared with placebo if a decision maker is willing to pay about €2 per day, per avoided exacerbation. Conclusion: This economic analysis suggests that the clinical benefits of using budesonide/formoterol in a single inhaler are achieved at a numerically lower total healthcare cost than either monocomponent or placebo. Budesonide/formoterol in patients with severe COPD (GOLD stages III or IV) may be cost effective, from the healthcare provider perspective, compared with either monocomponent.

PRP11 THE VALIDITY OF THE WORK PRODUCTIVITY AND ACTIVITY IMPAIRMENT QUESTIONNAIRE FOR PATIENTS WITH ASTHMA (WPAIASTHMA): RESULTS FROM A WEB-BASED STUDY

variate analyses, significant differences in the three questionnaires scores were observed according to gender, disease severity, symptoms and use of on-demand short acting beta-agonists. The cross-sectional and longitudinal correlations were strong between the questionnaires and EQ-5D as well as between the questionnaires and symptoms. The Pearson correlation between the questionnaires and FEV1 (% of predicted value) was weak. The effect size between both visits were 0.91, 0.7 and 1 for MiniAQLQ, Marks-AQLQ and AQLQ respectively. CONCLUSIONS: The three questionnaires are reliable, valid and sensitive to changes. Mini-AQLQ is better on feasibility making it a more efficient way to assess quality of life in adults with mild to moderate asthma.

Formoterol used as needed improves health-related quality of life in asthmatic patients uncontrolled with inhaled corticosteroids

Clinical benefits have been shown to occur when using the long-acting beta2-agonist formoterol 4.5 microg for as-needed medication rather than terbutaline 500 microg in patients with unstable asthma taking an inhaled corticosteroid. This study compared their effects on health-related quality of life and the relation with conventional clinical indices in the same population. 362 asthmatics were randomized to use either formoterol 4.5 microg or terbutaline 500 microg as needed, both inhaled via Turbuhaler. The Asthma Quality of Life Questionnaire (AQLQ) was practised at enrolment and completed by 341 patients after randomization and at 4, 8, and 12 weeks. Clinical indices were measured at the same time points. Mean overall AQLQ scores were comparable at baseline, being 4.90 in the formoterol and 4.82 in the terbutaline group and improved during treatment by 0.41 and 0.17 units, respectively (mean difference 0.24, 95% CI 0.08, 0.39, P<0.005). Mean improvement in the symptom domain was 0.49 units when using formoterol. Correlations between changes in clinical indices and changes in AQLQ scores during the 12-week period were weak (maximum r value=0.37). When used for as-needed medication, formoterol 4.5 microg provided an improvement in asthma-specific quality of life and to a somewhat greater extent than the widely used terbutaline 500 microg. The symptom domain in AQLQ showed almost 0.5 units improvement after formoterol, a change that is considered to be clinically relevant.

PMI1 FROM HEALTH-RELATED QOL TO UTILITY— IS THERE A WAY?

OBJECTIVE: To predict utility values from health-related quality of life (HRQL) assessments could, if possible, be a fruitful way to use HRQL assessments for health economic evaluations. With this in mind, we compared values for SF-6D, an index derived from the domain values of SF-36 by an algorithm from Brazier et al., with values from the EuroQol instrument, the EQ-5D index, and the EQ-VAS (Visual Analog Scale). METHODS: Data from two surveys of patients with respiratory disease were used in this comparison. The first data set was from 120 patients in the northern part of Sweden with COPD, and the other dataset from 206 patients in Hungary suffering from asthma. Both surveys covered patients with different severity of the disease. The two datasets were analyzed separately. The EQ-VAS values were rescaled from a range of 0–100 to a 0–1 range. RESULTS: Results are consistent for the two different data sets and shows an expected gradient for severity groups in both cases. SF-6D has on the average slightly lower values than EQ-5D but higher than EQ-VAS (Mean for COPD: 0.74 vs 0.78 and 0.65; ASTHMA: 0.69 vs. 0.70 and 0.62). On the other hand, both EQ-5D and EQVAS have larger variation with a substantial proportion of patients reaching maximum or minimum achievable values. Correlations between the different indices are deceptively high because of extreme values (r for COPD: 0.75–0.69; ASTHMA: 0.70–0.49). CONCLUSION: SF-6D shows a response pattern more in line with intuitive expectation than EQ-5D and EQVAS, which both seem to have a ceiling (and floor) problem.