[Effectiveness of the Assessment of Burden of COPD tool: a cluster-randomised controlled trial]. / Effectiviteit van de 'Ziektelastmeter COPD'.

OBJECTIVE: Assessment of the effectiveness of the Assessment of Burden of COPD (ABC) tool on disease-specific quality of life in patients with Chronic Obstructive Pulmonary Disease (COPD). DESIGN: Cluster-randomised controlled trial. METHOD: This concerned a trial in 39 Dutch primary care practices and 17 hospitals, involving 357 patients with COPD (postbronchodilator FEV1/FVC ratio < 0.7) aged ≥ 40 years. Healthcare providers were randomized to an intervention or control group. Patients in the intervention group were treated with the ABC tool. This innovative tool consists of a short validated questionnaire and a number of objective parameters, which collectively give a visual overview of the combined integral health; the tool subsequently produces an individualized treatment plan by means of a treatment algorithm. Patients in the control group received usual care. The primary outcome measure was the proportion of patients with a clinically relevant improvement in disease-specific quality of life measured, as measured by means of the St. George's Respiratory Questionnaire (SGRQ) score, between baseline and 18 months follow-up. Secondary outcomes included the SGRQ total score and the Patient Assessment of Chronic Illness Care (PACIC) score. RESULTS: At 18-month follow-up, a significant and clinically relevant improvement in the SGRQ score was seen in 34% of the patients (N=49) in the intervention group, and in the control group this figure was 22% (N=33). This difference between the two groups was significant (OR 1.85, 95% CI 1.08 to 3.16). Patients in the intervention group experienced a higher quality of care than patients in the control group (0.32 points difference in PACIC, 95% CI 0.14 to 0.50). CONCLUSION: Use of the ABC tool increases the disease-specific quality of life and the quality of care for COPD patients; it may therefore offer a valuable contribution to improvements in the daily care of COPD. Replication of this study in other (non-Dutch) health-care settings is recommended.

Comparison of EQ-5D and SF-6D utilities in Pompe disease.

PURPOSE: Comparative studies between Euroqol-5D (EQ-5D) and ShortForm 6D (SF-6D) utilities have been performed for a number of diseases, but not yet for orphan diseases. Pompe disease is an orphan disease with a prevalence of <5/10,000, characterized by impaired ambulatory and pulmonary functioning. We compared the psychometric properties of EQ-5D and SF-6D in patients with this disease and assessed their convergent validity, discriminative ability and sensitivity to change. METHODS: EQ-5D utilities and SF-6D utilities were computed using the UK value set. Dimensions and utilities of the two instruments were compared by correlation coefficients and descriptive statistics. We assessed whether EQ-5D and SF-6D were able to discriminate between different levels of severity and examined sensitivity to change for patients with multiple observations. RESULTS: Correlations between theoretically related dimensions of the EQ-5D and SF-6D were highly significant and were moderate to strong (range rho = 0.409-0.564). Utility values derived from the two instruments were similar (mean EQ-5D = 0.670; mean SF-6D = 0.699) and correlated strongly (rho = 0.591). Discriminative properties were somewhat better for EQ-5D; mean changes and effect sizes were better for SF-6D. CONCLUSIONS: Overall, we conclude that both instruments appear to be equally appropriate with respect to assessing utilities in Pompe disease, but neither of them performed excellently. The descriptive system of the SF-6D describes health states for Pompe disease more accurately. EQ-5D showed better discriminative properties. The SF-6D performed better with respect to sensitivity to change.

Which long-acting bronchodilator is most cost-effective for the treatment of COPD?

BACKGROUND: The aim of this study was to estimate the cost-effectiveness of tiotropium versus salmeterol to inform decision making within the Dutch healthcare setting. METHODS: A previously published, validated COPD progression model was updated with new exacerbation data and adapted to the Dutch setting by including Dutch estimates of healthcare use for COPD maintenance treatment and Dutch unit costs. Exacerbation data from the POET-COPD trial were combined with evidence from earlier tiotropium studies using Bayesian meta-analysis. The model-based analysis was performed using a one- and five-year time horizon. Main health outcomes were the number of exacerbations and quality-adjusted life years (QALYs). RESULTS: One-year costs per patient from the healthcare perspective were v1370 for tiotropium and v1359 for salmeterol; a difference of v11 (95% uncertainty interval (UI): -198-212). The annual number of exacerbations was 0.068 (-0.005-0.140) lower in the tiotropium group. The number of QALYs in the tiotropium group was 0.011 (-0.019-0.049) higher, resulting in an incremental cost-effectiveness ratio (ICER) of v1015 per QALY. After five years, the difference in exacerbations, QALYs and costs between the tiotropium and salmeterol group were -0.435 (-0.915-0.107), 0.079 (-0.272-0.520) and v-277 (-1586-1074), respectively, indicating that tiotropium was more effective and less costly. Using a societal perspective, tiotropium dominated salmeterol both after one and five years. CONCLUSION: Tiotropium reduced exacerbations and exacerbation-related costs. After one year the cost per QALY of tiotropium compared with salmeterol was very low, while after five years tiotropium was found to dominate salmeterol.

Bottom-up implementation of disease-management programmes: results of a multisite comparison.

OBJECTIVES: To evaluate the implementation of three regional disease-management programmes on chronic obstructive pulmonary disease (COPD) based on bottlenecks experienced in professional practice. METHODS: The authors performed a multisite comparison of three Dutch regional disease-management programmes combining patient-related, professional-directed and organisational interventions. Process (Assessing Chronic Illness Care survey) and outcome (disease specific quality of life (clinical COPD questionnaire (CCQ); chronic respiratory questionnaire (CRQ)), Medical Research Council dyspnoea and patients' experiences) data were collected for 370 COPD patients and their care providers. RESULTS: Bottlenecks in region A were mostly related to patient involvement, in region B to organisational issues and in region C to both. Selected interventions related to identified bottlenecks were implemented in all programmes, except for patient-related interventions in programme A. Within programmes, significant improvements were found on dyspnoea and patients' experiences with practice nurses. Outcomes on quality of life differed between programmes: programme A did not show any significant improvements; programme B did show any significant improvements on CCQ total (p<0.001), functional (p=0.011) and symptom (p<0.001), CRQ fatigue (p<0.001) and emotional scales (p<0.001); in programme C, CCQ symptom (p<0.001) improved significantly, whereas CCQ mental score (p<0.001) deteriorated significantly. Regression analyses showed that programmes with better implementation of selected interventions resulted in relatively larger improvements in quality of life (CCQ). CONCLUSIONS: Bottom-up implementation of COPD disease-management programmes is a feasible approach, which in multiple settings leads to significant improvements in outcomes of care. Programmes with a better fit between implemented interventions and bottlenecks showed more positive changes in outcomes.

Short- and long-term efficacy of a community-based COPD management programme in less advanced COPD: a randomised controlled trial.

BACKGROUND: The effectiveness of pulmonary rehabilitation in advanced COPD is well established, but few data are available in less advanced disease. METHODS: In a 2 year randomised controlled trial, 199 patients with an average moderate airflow obstruction but impaired exercise capacity (mean (SD) forced expiratory volume in 1 s (FEV(1)) 60 (16)%, peak work load (Wmax) <70%) were randomised to the INTERdisciplinary COMmunity-based COPD management programme (INTERCOM) or usual care. Intervention consisted of 4 months multidisciplinary rehabilitation followed by a 20-month maintenance phase. Outcomes (4, 12, 24 months): health-related quality of life (St George's Respiratory Questionnaire (SGRQ)), exacerbation frequency, MRC dyspnoea score, cycle endurance time (CET), 6-minute walking distance (6MWD), skeletal muscle strength and patients' and caregivers' perceived effectiveness. RESULTS: Between-group comparison after 4 months revealed the following mean (SE) significant differences in favour of INTERCOM: SGRQ total score 4.06 (1.39), p = 0.004; activity and impact subscores, p<0.01; MRC score 0.33 (0.13), p = 0.01; Wmax 6.0 (2.3) Watt, p = 0.02; CET 221 (104) s, p = 0.04; 6MWD 13 (6) m, p = 0.02; hand grip force 4.3 (1.5) lb, p<0.01; and fat-free mass index 0.34 (0.13) kg/m(2), p = 0.01. Between-group differences over 2 years were as follows: SGRQ 2.60 (1.3), p = 0.04; MRC score 0.21 (0.10), p = 0.048; CET 253 (104) s, p = 0.0156; 6MWD 18 (8) m, p = 0.0155. Exacerbation frequency was not different (RR 1.29 (95% CI 0.89 to 1.87)). Patients' and caregivers' perceived effectiveness significantly favoured the INTERCOM programme (p<0.01). CONCLUSIONS: This study shows that a multidisciplinary community-based disease management programme is also effective in patients with COPD with exercise impairment but less advanced airflow obstruction.

Is INTERdisciplinary COMmunity-based COPD management (INTERCOM) cost-effective?

The study aimed to estimate the cost-effectiveness of interdisciplinary community-based chronic obstructive pulmonary disease (COPD) management in patients with COPD. We conducted a cost-effectiveness analysis alongside a 2-yr randomised controlled trial, in which 199 patients with less advanced airflow obstruction and impaired exercise capacity were assigned to the INTERCOM programme or usual care. The INTERCOM programme consisted of exercise training, education, nutritional therapy and smoking cessation counselling offered by community-based physiotherapists and dieticians and hospital-based respiratory nurses. All-cause resource use during 2 yrs was obtained by self-report and from hospital and pharmacy records. Health outcomes were the St George's Respiratory Questionnaire (SGRQ), exacerbations and quality-adjusted life years (QALYs). The INTERCOM group had 30% (95% CI 3-56%) more patients with a clinically relevant improvement in SGRQ total score, 0.08 (95% CI -0.01-0.18) more QALYs per patient, but a higher mean number of exacerbations, 0.84 (95% CI -0.07-1.78). Mean total 2-yr costs were euro2,751 (95% CI -euro632-euro6,372) higher for INTERCOM than for usual care, which resulted in an incremental cost-effectiveness ratio of euro9,078 per additional patient with a relevant improvement in SGRQ or euro32,425 per QALY. INTERCOM significantly improved disease-specific quality of life, but did not affect exacerbation rate. The cost per QALY ratio was moderate, but within the range of that generally considered to be acceptable.

[Projections of future resource use and the costs of asthma and COPD in the Netherlands]. / Toekomstprojecties van het zorggebruik en de kosten van astma en COPD in Nederland.

OBJECTIVE: To determine the health-care utilisation and associated costs for asthma and chronic obstructive pulmonary disease (COPD) in the Netherlands for the year 2000 and to estimate future costs by means of projections. DESIGN: Descriptive and explorative. METHOD: The costs were based on data regarding resource use in 2000 obtained from representative national registries and surveys. The costs were specified by gender and age category and for COPD also by severity. Three projections for the costs of asthma and COPD were made by means of prevalence projections: first assuming constant resource use and constant prices, second assuming asthma- and COPD-specific trends in the costs for hospital care (asthma, -4.7% and COPD, -4.1% per year) and medication (+4.9% per year), and third by adding general trends for the remaining types of care. RESULTS: Total costs for the year 2000 for asthma (452,000 patients) and COPD (306,000 patients) were estimated to be 141 and 280 million Euros, amounting to 313 en 915 Euros per patient or 9 and 18 Euros per inhabitant, respectively. Projections of total prevalence for the year 2025 varied between 478,000 and 568,000 patients for asthma and between 479,000 and 494,000 patients for COPD. Assuming constant resource use and prices, the costs in 2025 were projected to increase to amounts between 167 and 181 million Euros for asthma and 443 and 495 million Euros for COPD. Projections including the estimated trends in costs for hospital care, medication and the costs for other types of care predicted a sharper increase. CONCLUSION: Costs for asthma and COPD together (421 million Euros) amounted to 1.3% of the total Dutch health-care budget in 2000. Almost 70% of these costs were for COPD. Projections for 2025 showed that the costs for COPD will increase more than the costs for asthma.

A dynamic population model of disease progression in COPD.

To contribute to evidence-based policy making, a dynamic Dutch population model of chronic obstructive pulmonary disease (COPD) progression was developed. The model projects incidence, prevalence, mortality, progression and costs of diagnosed COPD by the Global Initiative for Chronic Obstructive Lung Disease-severity stage for 2000-2025, taking into account population dynamics and changes in smoking prevalence over time. It was estimated that of all diagnosed COPD patients in 2000, 27% had mild, 55% moderate, 15% severe and 3% very severe COPD. The severity distribution of COPD incidence was computed to be 40% mild, 55% moderate, 4% severe and 0.1% very severe COPD. Disease progression was modelled as decline in forced expiratory volume in one second (FEV1) % predicted depending on sex, age, smoking and FEV1 % pred. The relative mortality risk of a 10-unit decrease in FEV1 % pred was estimated at 1.2. Projections of current practice were compared with projections assuming that each year 25% of all COPD patients receive either minimal smoking cessation counselling or intensive counselling plus bupropion. In the projections of current practice, prevalence rates between 2000-2025 changed from 5.1 to 11 per 1,000 inhabitants for mild, 11 to 14 per 1,000 for moderate, 3.0 to 3.9 per 1,000 for severe and from 0.5 to 1.3 per 1,000 for very severe COPD. Costs per inhabitant increased from 1.40 Euro to 3.10 for mild, 6.50 Euro to 9.00 for moderate, 6.20 Euro to 8.50 for severe and from 3.40 Euro to 9.40 for very severe COPD (price level 2000). Both smoking cessation scenarios were cost-effective with minimal counselling generating net savings. In conclusion, the chronic obstructive pulmonary disease progression model is a useful instrument to give detailed information about the future burden of chronic obstructive pulmonary disease and to assess the long-term impact of interventions on this burden.

One-year cost-effectiveness of tiotropium versus ipratropium to treat chronic obstructive pulmonary disease.

The aim of this paper is to assess the health economic consequences of substituting ipratropium with the new, once-daily bronchodilator tiotropium in patients with a diagnosis of chronic obstructive pulmonary disease (COPD). This prospective cost-effectiveness analysis was performed alongside two 1-yr randomised, double-blind clinical trials in the Netherlands and Belgium. Patients had a diagnosis of COPD and a forced expiratory volume in one second (FEV1) < or = 65% predicted normal. Patients were randomised to tiotropium (18 microg once daily) or ipratropium (2 puffs of 20 microg administered four times daily) in a ratio of 2:1. The mean number of exacerbations was reduced from 1.01 in the ipratropium group (n = 175) to 0.74 in the tiotropium group (n = 344). The percentages of patients with a relevant improvement on the St. George's Respiratory Questionnaire (SGRQ) were 34.6% and 51.2%, respectively. Compared to ipratropium, the number of hospital admissions, hospital days and unscheduled visits to healthcare providers was reduced by 46%, 42% and 36% respectively. Mean annual healthcare costs including the acquisition cost of the study drugs were 1721 Euro (SEM 160) in the tiotropium group and 1,541 Euro (SEM 163) in the ipratropium group (difference 180 Euro). Incremental cost-effectiveness ratios were 667 Euro per exacerbation avoided and 1084 Euro per patient with a relevant improvement on the SGRQ. Substituting tiotropium for ipratropium in chronic obstructive pulmonary disease patients offers improved health outcomes and is associated with increased costs of 180 Euro per patient per year.