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1.  Early assisted discharge with generic community nursing for chronic obstructive pulmonary disease exacerbations: results of a randomised controlled trial 
BMJ Open  2012;2(5):e001684.
To determine the effectiveness of early assisted discharge for chronic obstructive pulmonary disease (COPD) exacerbations, with home care provided by generic community nurses, compared with usual hospital care.
Prospective, randomised controlled and multicentre trial with 3-month follow-up.
Five hospitals and three home care organisations in the Netherlands.
Patients admitted to the hospital with an exacerbation of COPD. Patients with no or limited improvement of respiratory symptoms and patients with severe unstable comorbidities, social problems or those unable to visit the toilet independently were excluded.
Early discharge from hospital after 3 days inpatient treatment. Home visits by generic community nurses. Primary outcome measure was change in health status measured by the Clinical COPD Questionnaire (CCQ). Treatment failures, readmissions, mortality and change in generic health-related quality of life (HRQL) were secondary outcome measures.
139 patients were randomised. No difference between groups was found in change in CCQ score at day 7 (difference in mean change 0.29 (95% CI −0.03 to 0.61)) or at 3 months (difference in mean change 0.04 (95% CI –0.40 to 0.49)). No difference was found in secondary outcomes. At day 7 there was a significant difference in change in generic HRQL, favouring usual hospital care.
While patients’ disease-specific health status after 7-day treatment tended to be somewhat better in the usual hospital care group, the difference was small and not clinically relevant or statistically significant. After 3 months, the difference had disappeared. A significant difference in generic HRQL at the end of the treatment had disappeared after 3 months and there was no difference in treatment failures, readmissions or mortality. Early assisted discharge with community nursing is feasible and an alternative to usual hospital care for selected patients with an acute COPD exacerbation.
Trial registration: NetherlandsTrialRegister NTR 1129.
PMCID: PMC3488726  PMID: 23075570
Primary Care
2.  Largely ignored: the impact of the threshold value for a QALY on the importance of a transferability factor 
Recently, several checklists systematically assessed factors that affect the transferability of cost-effectiveness (CE) studies between jurisdictions. The role of the threshold value for a QALY has been given little consideration in these checklists, even though the importance of a factor as a cause of between country differences in CE depends on this threshold. In this paper, we study the impact of the willingness-to-pay (WTP) per QALY on the importance of transferability factors in the case of smoking cessation support (SCS). We investigated, for several values of the WTP, how differences between six countries affect the incremental net monetary benefit (INMB) of SCS. The investigated factors were demography, smoking prevalence, mortality, epidemiology and costs of smoking-related diseases, resource use and unit costs of SCS, utility weights and discount rates. We found that when the WTP decreased, factors that mainly affect health outcomes became less important and factors that mainly effect costs became more important. With a WTP below €1,000, the factors most responsible for between country differences in INMB were resource use and unit costs of SCS and the costs of smoking-related diseases. Utility values had little impact. At a threshold above €10,000, between country differences were primarily due to different discount rates, utility weights and epidemiology of smoking-related diseases. Costs of smoking-related diseases had little impact. At all thresholds, demography had little impact. We concluded that, when judging the transferability of a CE study, we should consider the between country differences in WTP threshold values.
PMCID: PMC3160548  PMID: 20512607
Multinational; Transferability; Threshold value; Smoking cessation; Willingness-to-pay; Cost-effectiveness; QALY; I1
3.  Systemic impairment in relation to disease burden in patients with moderate COPD eligible for a lifestyle program. Findings from the INTERCOM trial 
In contrast with the frequency distribution of chronic obstructive pulmonary disease (COPD) stages in the population, in which the majority of the patients is classified as GOLD 2, much less information is available on the prevalence and implications of systemic manifestations in less severe patients relative to GOLD 3 and 4.
To characterize local and systemic impairment in relation to disease burden in a group of GOLD 2 COPD patients (n = 127, forced expiratory volume in one second (SD): 67 (11)% pred) that were eligible for the Interdisciplinary Community-based COPD management (INTERCOM) trial.
Patients were included for this lifestyle program based on a peak exercise capacity (Wmax) <70% of predicted. Metabolic and ventilatory response to incremental cycle ergometry, 6 minute walking distance (6MWD), constant work rate test (CWR), lung function, maximal inspiratory pressure (Pimax), quadriceps force (QF), quadriceps average power (QP) (isokinetic dynamometry), handgrip force (HGF) and body composition were measured. Quality of life (QoL) was assessed by the St. George’s Respiratory Questionnaire (SGRQ) and dyspnea by the modified Medical Research Council (MRC) dyspnea scale. Exacerbations and COPD-associated hospital admissions in 12 months prior to the start of the study were recorded. Burden of disease was defined in terms of exercise capacity, QoL, hospitalization, and exacerbation frequency. GOLD 2 patients were compared with reference values and with GOLD 3 patients who were also included in the trial.
HGF (77.7 (18.8) % pred) and Pimax (67.1 (22.5)% pred) were impaired in GOLD 2, while QF (93.5 (22.5)% pred) was only modestly decreased. Depletion of FFM was present in 15% of weight stable GOLD 2 patients while only 2% had experienced recent involuntary weight loss. In contrast to Wmax, submaximal exercise capacity, muscle function, and body composition were not significantly different between GOLD 2 and 3 subgroups. Body mass index and fat-free mass index were significantly lower in smokers compared to ex-smokers. In multivariate analysis, QF and diffusing capacity (DLco) were independently associated with Wmax and 6 MWD in GOLD 2 while only 6 MWD was identified as an independent determinant of health-related QoL. HGF was an independent predictor of hospitalization.
This study shows that also in patients with moderate COPD, eligible for a lifestyle program based on a decreased exercise capacity, systemic impairment is an important determinant of disease burden and that smoking affects body composition.
PMCID: PMC2629991  PMID: 18990973
COPD; systemic impairment; lifestyle; pulmonary rehabilitation
4.  Modelling the 5-year cost effectiveness of tiotropium, salmeterol and ipratropium for the treatment of chronic obstructive pulmonary disease in Spain 
Our objective was to assess the 5-year cost effectiveness of bronchodilator therapy with tiotropium, salmeterol or ipratropium for chronic obstructive pulmonary disease (COPD) from the perspective of the Spanish National Health System (NHS). A probabilistic Markov model was designed wherein patients moved between moderate, severe or very severe COPD and had the risk of exacerbation and death. Probabilities were derived from clinical trials. Spanish healthcare utilisation, costs and utilities were estimated for each COPD and exacerbation state. Outcomes were exacerbations, exacerbation-free months, quality-adjusted life years (QALYs), and cost(-effectiveness). The mean (SE) 5-year number of exacerbations was 3.50 (0.14) for tiotropium, 4.16 (0.40) for salmeterol and 4.71 (0.54) for ipratropium. The mean (SE) number of QALYs was 3.15 (0.08), 3.02 (0.15) and 3.00 (0.20), respectively. Mean (SE) 5-year costs were €6,424 (€305) for tiotropium, €5,869 (€505) for salmeterol, and €5,181 (€682) for ipratropium (2005 values). Ipratropium and tiotropium formed the cost-effectiveness frontier, with tiotropium being preferred when willingness to pay (WTP) exceeded €639 per exacerbation-free month and €8,157 per QALY. In Spain, tiotropium demonstrated the highest expected net benefit for ratios of the willingness to pay per QALY, well within accepted limits.
PMCID: PMC1913175  PMID: 17370096
Chronic obstructive pulmonary disease (COPD); Bronchodilators; Model; Cost effectiveness; Quality-adjusted life year (QALY); Spain
5.  The management of cardiovascular disease in the Netherlands: analysis of different programmes 
Disease management programmes are increasingly used to improve the efficacy and effectiveness of chronic care delivery. But, disease management programme development and implementation is a complex undertaking that requires effective decision-making. Choices made in the earliest phases of programme development are crucial, as they ultimately impact costs, outcomes and sustainability.
To increase our understanding of the choices that primary healthcare practices face when implementing such programmes and to stimulate successful implementation and sustainability, we compared the early implementation of eight cardiovascular disease management programmes initiated and managed by healthcare practices in various regions of the Netherlands. Using a mixed-methods design, we identified differences in and challenges to programme implementation in terms of context, patient characteristics, disease management level, healthcare utilisation costs, development costs and health-related quality of life.
Shifting to a multidisciplinary, patient-centred care pathway approach to disease management is demanding for organisations, professionals and patients, and is especially vulnerable when sustainable change is the goal. Funding is an important barrier to sustainable implementation of cardiovascular disease management programmes, although development costs of the individual programmes varied considerably in relation to the length of the development period. The large number of professionals involved in combination with duration of programme development was the largest cost drivers. While Information and Communication Technology systems to support the new care pathways did not directly contribute to higher costs, delays in implementation indirectly did.
Developing and implementing cardiovascular disease management programmes is time-consuming and challenging. Multidisciplinary, patient-centred care demands multifaceted changes in routine care. As care pathways become more complex, they also become more expensive. Better preparedness and training can prevent unnecessary delays during the implementation period and are crucial to reducing costs.
PMCID: PMC3807633  PMID: 24167456
cardiovascular disease management; integrated care pathways; chronic care delivery; programme implementation; the Netherlands

Results 1-5 (5)