Key Points
Question
Does a multimodal nonpharmacological approach prevent delirium in older patients undergoing elective surgical procedures?
Findings
This stepped-wedge cluster trial recruited 1470 patients 70 years and older who were randomized in 5 clusters to patient-centered evidence-based intervention (ie, personalized stimulation, company, relaxation) vs routine care. The intervention reduced delirium incidence after various major procedures, most significantly in patients undergoing noncardiac surgery; the intervention did not change cardiac surgery postoperative delirium incidence.
Meaning
Results of this stepped-wedge cluster trial suggest the implementation of this multimodal nonpharmacological delirium prevention program may improve delivery of targeted care and patient outcomes in older patients undergoing elective noncardiac surgical procedures.
Background: Many established products (EPs – marketed for eight years or more) are widely used off-label despite little evidence on benefit–risk ratio. This exposes patients to risks related to safety and lack of efficacy, and healthcare providers to liability. Introducing new indications for EPs may represent a high societal value; however, manufacturers rarely invest in R&D for EPs. The objective of this research was to describe incentives and disincentives for developing new indications for EPs in Europe and to investigate consequences of current policies.Methods: Targeted literature search and expert panel meetings.Results: Within the current European-level and national-level regulatory framework there are limited incentives for development of new indications with EPs. Extension of indication normally does not allow the price to be increased or maintained, the market protection period to be extended, or exclusion from a reference price system. New indication frequently triggers re-evaluation, resulting in price erosion, regardless of the level of added value with the new indication. In consequence, manufacturers are more prone to undertake R&D efforts at early to mid-stage of product life cycle rather than with EPs, or to invest in new chemical entities, even in therapeutic areas with broad off-label use. This represents a potentially missed opportunity as developing new indications for EPs offers an alternative to off-label use or lengthy and expensive R&D for new therapies, opens new opportunities for potentially cost-effective treatment alternatives, as well as greater equity in patients’ access to treatment options.Conclusion: There are potential benefits from the development of new indications for EPs that are currently not being realized due to a lack of regulatory and pricing incentives in Europe. Incentives for orphan or paediatric drugs have proven to be effective in promoting R&D. Similarly, incentives to promote R&D in EPs should be developed, for the benefit of patients and healthcare systems.
The aim of the present work was to identify published methodological guidance for rapid reviews (RRs) and to analyze the recommendations with regard to timesaving measures. A literature search was performed in PubMed and EMBASE in November 2020. In addition, a search based on Google Scholar and websites of
In diesem Papier werden erstens die Vergütungsunterschiede zwischen privat versicherten und gesetzlich versicherten Patienten in der ambulanten ärztlichen Versorgung sowohl relativ als auch in absoluten Zahlen quantifiziert. Zweitens wird eine mögliche Angleichung der Vergütungssysteme simuliert. Es wird berechnet, wie hoch die Belastung beziehungsweise die Entlastung für die jeweiligen Versicherungssysteme (gesetzliche Krankenversicherung und private Krankenversicherung bzw. Beihilfeträger) sein würde, wenn das Vergütungsniveau in der ambulanten ärztlichen Versorgung auf ein gemeinsames Niveau angepasst werden würde. Dies geschieht unter der Modellbedingung der Umsatzneutralität für die Ärzteschaft. Die Studie kommt zu dem Ergebnis, dass ein behandelnder Arzt im Durchschnitt für eine medizinisch im Grundsatz gleiche Leistung bei einem privat versicherten Patienten eine rd. 2,28fach höhere Vergütung als für einen gesetzlich versicherten Patienten erhält. In absoluten Beträgen erhalten die Ärzte insgesamt für die Behandlung privat versicherter Patienten 3,6 Mrd. € (jährlich) mehr, als wenn sie diese Patienten mit den gleichen Leistungen auf der Basis des Vergütungssystems in der gesetzlichen Krankenversicherung behandelt hätten. Soll ein einheitliches Vergütungssystem geschaffen werden, das für die Ärzte insgesamt umsatzneutral ist, würde sich für die gesetzliche Krankenversicherung eine Belastung von etwa 3,2 Mrd. € ergeben.
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