Cost-effectiveness of the COPD Patient Management European Trial home-based disease management program.

Purpose: Efficient management of COPD represents an international challenge. Effective management strategies within the means of limited health care budgets are urgently required. This analysis aimed to evaluate the cost-effectiveness of a home-based disease management (DM) intervention vs usual management (UM) in patients from the COPD Patient Management European Trial (COMET). Methods: Cost-effectiveness was evaluated in 319 intention-to-treat patients over 12 months in COMET. The analysis captured unplanned all-cause hospitalization days, mortality, and quality-adjusted life expectancy. Costs were evaluated from a National Health Service perspective for France, Germany, and Spain, and in a pooled analysis, and were expressed in 2015 Euros (EUR). Quality of life was assessed using the 15D health-related quality-of-life instrument and mapped to utility scores. Results: Home-based DM was associated with improved mortality and quality-adjusted life expectancy. DM and UM were associated with equivalent direct costs (DM reduced costs by EUR -37 per patient per year) in the pooled analysis. DM was associated with lower costs in France (EUR -806 per patient per year) and Spain (EUR -51 per patient per year), but higher costs in Germany (EUR 391 per patient per year). Evaluation of cost per death avoided and cost per quality-adjusted life year (QALY) gained showed that DM was dominant (more QALYs and cost saving) in France and Spain, and cost-effective in Germany vs UM. Nonparametric bootstrapping analysis, assuming a willingness-to-pay threshold of EUR 20,000 per QALY gained, indicated that the probability of home-based DM being cost-effective vs UM was 87.7% in France, 81.5% in Spain, and 75.9% in Germany. Conclusion: Home-based DM improved clinical outcomes at equivalent cost vs UM in France and Spain, and in the pooled analysis. DM was cost-effective in Germany with an incremental cost-effectiveness ratio of EUR 2,541 per QALY gained. The COMET home-based DM intervention could represent an attractive alternative to UM for European health care payers.

[Witch hunt and hypotheses loss]. / Von Hexenverfolgung und Hypothesenverlust.

At this time randomized controlled studies (RCT) in clinical trials usually have high quality. But this quality is only true for the included patients (intrinsic validity). It is common to generalize the results to more or less similar patients. This inductive method is prohibited in epistemology what is known for 250 years (D Hume, K R Popper). Therefore the external validity for the data of RCT is low. To solve this problem additional clinical and pathophysiological based data are necessary to generalize the results. Unfortunately RCT show less quality in their premises. This is partly due to the influence of the pharmaceutical industry. A loss of universality of the hypothesis for RCT decreases basically the extrinsic validity. The articles describe this problem with examples.

[TISS-28 in difficult to wean patients after long-term mechanical ventilation]. / Stellenwert des TISS-28-Scores in der schwierigen Entwöhnung vom Respirator.

PURPOSE: To compare the Therapeutic Intervention Scoring System (TISS) 28 in difficult to wean patients before and after transfer to a weaning center. PATIENTS AND METHODS: Using TISS-28, the authors investigated the difference between regular intensive care units (ICUs) and the respiratory ICU (RICU) of their hospital in difficult to wean patients after long-term mechanical ventilation (MV). Special emphasis was placed on the appropriateness of TISS-28 to cover the specific weaning activities. 63 tracheotomized patients ventilated for more than 14 days were included. RESULTS: In total, 15.9% of patients were not weaned, 20.6% of population was successfully weaned with noninvasive ventilation (NIV), and 63.5% of patients was successfully weaned without NIV. The transfer of patients from other ICUs to a weaning facility resulted in a significant reduction of total TISS-28 from 29.5 to 23.8 points (p<0.001) on average. CONCLUSION: The high weaning success rate in a specialized facility is associated with a significant reduction of TISS-28 scores. The use of TISS-28 in a weaning center for patients with prolonged MV to measure workload does not adequately mirror the efforts by physicians, nurses, physiotherapists, and other health-care personnel.