Multidimensional outcome assessment of pulmonary rehabilitation in traits-based clusters of COPD patients.

BACKGROUND: Clusters of COPD patients have been reported in order to individualize the treatment program. Neither co-morbidity clusters, nor integrated respiratory physiomics clusters contributed to a better prediction of outcomes. Based on a thoroughly assessed set of pulmonary and extra-pulmonary traits at the start of a pulmonary rehabilitation (PR) program, we recently described seven clusters of COPD patients. The aims of this study are to confirm multidimensional differential response and to assess the potential of pulmonary and extra-pulmonary traits-based clusters to predict this multidimensional response to PR pulmonary in COPD patients. METHODS: Outcomes of a 40-session PR program for COPD patients, referred by a chest physician, were evaluated based on the minimal clinically important difference (MCID) for 6-minute walk distance (6MWD), cycle endurance time, Canadian Occupational Performance Measure performance and satisfaction scores, Hospital Anxiety and Depression Scale anxiety and depression scores, MRC dyspnea grade and St George's Respiratory Questionnaire. The aforementioned response indicators were used to calculate the overall multidimensional response and patients were grouped in very good, good, moderate and poor responders. In the same way, responses to pulmonary rehabilitation were compared based on seven previously identified pulmonary and extra-pulmonary traits-based clusters. RESULTS: Of the whole sample, drop out was 19% and 419 patients (55.4% males, age: 64.3 ± 8.8, FEV1% of predicted: 48.9 ± 20) completed the pulmonary rehabilitation program. Very good responders had significantly worse baseline characteristics with a higher burden of disease, a higher proportion of rollator-users, higher body mass index (BMI), more limitations of activities in daily life, emotional dysfunction, higher symptoms of dyspnea and worse quality of life. Of the seven pre-identified clusters, 'the overall best functioning cluster' and 'the low disease burden cluster' both including the best 6MWD, the lowest dyspnea score and the overall best health status, demonstrated attenuated outcomes, while in 'the cluster of disabled patients', 76% of the patients improved health status with at least 2 times MCID. This 'cluster of disabled patients' as well as 'the multimorbid cluster', 'the emotionally dysfunctioning cluster', 'the overall worst-functioning cluster' and 'the physically dysfunctioning cluster' all demonstrated improvements in performance and satisfaction for occupational activities (more than 65% of patients improved with > 1MCID), emotional functioning (more than 50% of patients improved with > 1 MCID) and overall health status (more than 58%). CONCLUSION: The current study confirms the differential response to pulmonary rehabilitation based on multidimensional response profiling. Cluster analysis of baseline traits illustrates that non-linear, clinically important differences can be achieved in the most functionally and emotionally impaired clusters and that 'the overall best functional cluster' as well as 'the low disease burden cluster' had an attenuated outcome.

Salmeterol/fluticasone propionate versus fluticasone propionate plus montelukast: a cost-effective comparison for asthma.

INTRODUCTION AND OBJECTIVE: Asthma, owing to its chronic nature, is associated with a substantial economic burden. Healthcare providers need to compare the cost effectiveness of alternative asthma treatment options to ensure that they obtain the best value for money from the resources they control. The objective of the current study was to compare the cost effectiveness of salmeterol/fluticasone propionate in combination with fluticasone propionate plus montelukast in patients with symptomatic asthma uncontrolled with inhaled corticosteroid (ICS) monotherapy. STUDY DESIGN AND METHODS: Direct healthcare resource data were prospectively collected during a double-blind, randomized, 12-week clinical study of inhaled salmeterol/fluticasone propionate 50/100 microg twice daily (n = 356) and inhaled fluticasone propionate 100 microg twice daily plus oral montelukast 10mg daily (n = 369). Resources were costed in Dutch guilders (NLG) from the perspective of The Netherlands healthcare system using 1999/2000 prices, but have been presented in US dollars and euros. The primary effectiveness measure was the proportion of successfully treated weeks (based on mean morning PEF values). Secondary measures were episode-free days, symptom-free days, and symptom-free nights. RESULTS: Salmeterol/fluticasone propionate was more effective than fluticasone propionate plus montelukast as measured by the proportion of successfully treated weeks mean 63.3% vs 39.0%; median difference 25%; p < 0.001). Salmeterol/fluticasone propionate was also more effective than fluticasone propionate plus montelukast according to the secondary effectiveness measures. The mean total direct daily healthcare costs per patient were 16% higher with fluticasone propionate plus montelukast than with salmeterol/fluticasone propionate mainly due to higher drug costs in the former group (2.25 US dollars vs 1.94; 1.92 euro vs 1.66, respectively; the NLG was fixed against the euro at a rate of 1 euro = NLG2.2 on 31 December 1998; 1 US dollars = NLG1.883, June 2003; 1 US dollars= 0.848 euro, June 2003). Incremental cost-effectiveness analyses showed that salmeterol/fluticasone propionate was dominant over fluticasone propionate plus montelukast and sensitivity analyses showed these results to be robust. CONCLUSION: Salmeterol/fluticasone propionate is a more cost-effective treatment option than fluticasone propionate plus montelukast for patients with symptomatic asthma uncontrolled by ICS.

Quality of routine spirometry tests in Dutch general practices.

BACKGROUND: Spirometry is an indispensable tool for diagnosis and monitoring of chronic airways disease in primary care. AIM: To establish the quality of routine spirometry tests in general practice, and explore associations between test quality and patient characteristics. DESIGN OF STUDY: Analysis of routine spirometry test records. SETTING: Fifteen general practices which had a working agreement with a local hospital pulmonary function laboratory for spirometry assessment regarding test quality and interpretation. METHOD: Spirometry tests were judged by a pulmonary function technician and a chest physician. Proportions of test adequacy were analysed using markers for manoeuvre acceptability and test reproducibility derived from the 1994 American Thoracic Society spirometry guideline. Associations between quality markers and age, sex, and severity of obstruction were examined using logistic regression. RESULTS: Practices performed a mean of four (standard deviation = 2) spirometry tests per week; 1271 tests from 1091 adult patients were analysed; 96.4% (95% confidence interval [CI] = 95.6 to 97.2) of all tests consisted of ≥3 blows. With 60.6% of tests, forced expiratory time was the marker with the lowest acceptability rate. An overall 38.8% (95% CI = 36.0 to 41.6) of the tests met the acceptability as well as reproducibility criteria. Age, sex, and severity of obstruction were associated with test quality markers. CONCLUSION: The quality of routine spirometry tests was better than in previous reports from primary care research settings, but there is still substantial room for improvement. Sufficient duration of forced expiratory time is the quality marker with the highest rate of inadequacy. Primary care professionals should be aware of patient characteristics that may diminish the quality of their spirometry tests. Further research is needed to establish to what extent spirometry tests that are inadequate, according to stringent international expert criteria, result in incorrect clinical interpretations in general practice.