BackgroundPostoperative delirium is a common disorder in older adults that is associated with higher morbidity and mortality, prolonged cognitive impairment, development of dementia, higher institutionalization rates, and rising healthcare costs. The probability of delirium after surgery increases with patients’ age, with pre-existing cognitive impairment, and with comorbidities, and its diagnosis and treatment is dependent on the knowledge of diagnostic criteria, risk factors, and treatment options of the medical staff. In this study, we will investigate whether a cross-sectoral and multimodal intervention for preventing delirium can reduce the prevalence of delirium and postoperative cognitive decline (POCD) in patients older than 70 years undergoing elective surgery. Additionally, we will analyze whether the intervention is cost-effective.MethodsThe study will be conducted at five medical centers (with two or three surgical departments each) in the southwest of Germany. The study employs a stepped-wedge design with cluster randomization of the medical centers. Measurements are performed at six consecutive points: preadmission, preoperative, and postoperative with daily delirium screening up to day 7 and POCD evaluations at 2, 6, and 12 months after surgery. Recruitment goals are to enroll 1500 patients older than 70 years undergoing elective operative procedures (cardiac, thoracic, vascular, proximal big joints and spine, genitourinary, gastrointestinal, and general elective surgery procedures).DiscussionResults of the trial should form the basis of future standards for preventing delirium and POCD in surgical wards. Key aims are the improvement of patient safety and quality of life, as well as the reduction of the long-term risk of conversion to dementia. Furthermore, from an economic perspective, we expect benefits and decreased costs for hospitals, patients, and healthcare insurances.Trial registrationGerman Clinical Trials Register, DRKS00013311. Registered on 10 November 2017.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-3148-8) contains supplementary material, which is available to authorized users.
A reduction in sedentary behavior (SB) can contribute to the prevention of chronic diseases. This is the first umbrella review that summarizes the effectiveness and monetary costs of different types of interventions to reduce SB across all age groups and populations in different settings. We comprehensively searched seven databases for systematic reviews and meta-analyses and conducted an umbrella review of the effects of interventions to reduce SB. Additionally, we performed a meta-analysis of primary studies included in the umbrella review. Furthermore, we analyzed health economic aspects of interventions to reduce SB. We included 40 systematic reviews in our umbrella review, with 136 primary studies suitable for further meta-analyses.We found that interventions targeting the physical environment reduce SB most effectively in the majority of populations and settings. Workplace interventions reduced SB by À89.83 min/day (95% CI À124.58 to À55.09; p ≤ 0.0001). Twentytwo of 169 primary studies (13.0%) contained health economic information. The intervention costs per participant ranged from €0 to €3587. Our findings demonstrate that physical environment interventions most effectively reduce SB in a majority of populations and settings. Health economic information was reported in few studies and was mostly restricted to acquisition costs.
Zusammenfassung Hintergrund und Zielsetzung Kostenberechnungen sind ein wesentlicher Bestandteil gesundheitsökonomischer Evaluationen, weisen jedoch für den deutschen Versorgungskontext teilweise große Unterschiede im methodischen Vorgehen auf. Zielsetzung der vorliegenden Artikelserie ist es, einen konsentierten Vorschlag zu den Vorgehensweisen der Kostenberechnungen in verschiedenen Versorgungssektoren zu präsentieren und mit diesem einführenden Artikel allgemeine, Sektoren-unspezifische Aspekte in der Durchführung von Kostenberechnungen zu beschreiben. Methodik In der Arbeitsgruppe „Standardkosten“ des Ausschusses „Ökonomische Evaluation und Entscheidungsfindung“ haben sich Wissenschaftlerinnen und Wissenschaftler von Universitäten und Entscheidungsträgern im Gesundheitswesen zusammengeschlossen, um die bestehenden Probleme bei Kostenberechnungen im Rahmen gesundheitsökonomischer Forschungen zu diskutieren und ein einheitliches Vorgehen zu erarbeiten. Zur Entwicklung der Empfehlungen fanden drei Arbeitstreffen sowie weitere Telefonkonferenzen statt. Die vorläufigen Ergebnisse wurden auf der 11. Jahrestagung der dggö der Fachöffentlichkeit vorgestellt. Ergebnisse Im vorliegenden ersten Artikel einer zunächst fünf Artikel umfassenden Serie werden grundsätzliche Themen der Perspektivwahl, des Preis-Mengengerüstes, der Studienarten, der Kostenkomponenten, der Datenquellen, der Anpassung von Kostendaten über die Zeit oder über Ländergrenzen hinweg sowie der Umgang mit Unsicherheit behandelt und Empfehlungen zu diesen Themen gegeben. Des Weiteren wird die Gliederung von später folgenden vier Artikeln zu den Berechnungsmethoden in einzelnen Versorgungssektoren beschrieben.
Background: Upper airway stimulation (UAS) is a treatment approach for patients with moderate-to-severe obstructive sleep apnea who cannot adhere to continuous positive airway pressure therapy. Objective: The objective was to evaluate added patient benefit and cost-effectiveness of UAS in the German health care system. Methods: We used a decision-analytic Markov model to project major adverse cardiovascular or cerebrovascular events (myocardial infarction [MI] or stroke), motor vehicle collision (MVC), mortality, quality-adjusted life years (QALYs), and costs. The assumed reduction in the apnea-hypopnea index with UAS compared to no treatment is based on German real-world data. Other input data were derived from the literature, public statistics, and multivariate regression. Cost-effectiveness was evaluated in Euros per QALY gained, both discounted at 3%. Results: UAS was projected to reduce event risks (10-year relative risk for stroke, MI, cardiovascular death, and MVC: 0.76, 0.64, 0.65, and 0.34, respectively), and to increase survival by 1.27 years. While the UAS strategy incurred an additional 1.02 QALYs within the patient lifetime, there were also additional costs of EUR 45,196, resulting in an incremental cost-effectiveness ratio of EUR 44,446 per QALY gained. Conclusions: In the present model-based analysis, UAS therapy provides meaningful benefit to patient-relevant endpoints and is a cost-effective therapy in the German setting.
Background Among potentially modifiable risk factors for delirium, transfers between wards, hospitals and other facilities have been mentioned with low evidence. TRADE (TRAnsport and DElirium in older people) was set up to investigate i) the impact of transfer and/or discharge on the onset of delirium in older adults and ii) feasibility and acceptance of a developed complex intervention targeting caregiver’s participation during and after hospital discharge or transfer on cognition and the onset of delirium in older adults. Methods The study is designed according to the guidelines of the UK Medical Research Council (MRC) for development and evaluation of complex interventions and comprises two steps: development and feasibility/piloting. The development phase includes i) a multicenter observational prospective cohort study to assess delirium incidence and cognitive decline associated with transfer and discharge, ii) a systematic review of the literature, iii) stakeholder focus group interviews and iv) an expert workshop followed by a Delphi survey. Based on this information, a complex intervention to better and systematically involve family caregivers in discharge and transport was developed. The intervention will be tested in a pilot study using a stepped wedge design with a detailed process and health economic evaluation. The study is conducted at four acute care hospitals in southwest Germany. Primary endpoints are the delirium incidence and cognitive function. Secondary endpoints include prevalence of caregiver companionship, functional decline, cost and cost effectiveness, quality of discharge management and quality of admission management in admitting hospitals or nursing homes. Data will be collected prior to discharge as well as after 3, 7 and 90 days. Discussion TRADE will help to evaluate transfer and discharge as a possible risk factor for delirium. In addition, TRADE evaluates the impact and modifiability of caregiver’s participation during patient’s transfer or discharge on delirium incidence and cognitive decline providing the foundation for a confirmatory implementation study. Trial registration DRKS (Deutsches Register für klinische Studien) DRKS00017828. Registered on 17th September 2019. Retrospectively registered.
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