Bypass materials in vascular surgery

Introduction: Arteriosclerotic changes can lead to circulatory disturbances in various areas of the human vascular system. In addition to pharmacological therapy and the management of risk factors (e. g. hypertension, diabetes, lipid metabolism disorders, and lifestyle), surgical interventions also play an important role in the treatment of arteriosclerosis. Long-segment arterial occlusions, in particular, can be treated successfully with bypass sur-gery. A number of different materials are available for this type of operation, such as autologous vein or pros-thetic grafts comprised of polytetrafluoroethylene (PTFE) or Dacron®. Prosthetic materials are used especially in the treatment of peripheral artery disease, such as in aortoiliac or femoropopliteal bypass surgery. The present report will thus focus on this area in order to examine the effectiveness of different bypass materials. Among the efforts being made to refine the newly introduced DRG system in Germany, analysing the different bypass materials used in vascular surgery is particularly important. Indeed, in its current version the German DRG system does not distinguish between bypass materials in terms of reimbursement rates. Differences in cost structures are thus of especial interest to hospitals in their budget calculations, whereas both private and statutory health insurance funds are primarily interested in long-term results and their costs. Objectives: The goal of this HTA is to compare the different bypass materials used in vascular surgery in terms of their medical efficiency and cost-effectiveness, as well as with regard to their ethical, social and legal implications. In addition, this report aims to point out the areas in which further medical, epidemiological and health economic research is still needed. Methods: Relevant publications were identified by means of a structured search of databases accessed through the German Institute of Medical Documentation and Information (DIMDI), as well as by a manual search. The for-mer included the following electronic resources: SOMED (SM78), Cochrane Library - Central (CCTR93), MEDLINE Alert (ME0A), MEDLINE (ME95), CATFILEplus (CATLINE) (CA66), ETHMED (ED93), GeroLit (GE79), HECLINET (HN69), AMED (CB85), CAB Abstracts (CV72), GLOBAL Health (AZ72), IPA (IA70), El-sevier BIOBASE (EB94), BIOSIS Previews (BA93), EMBASE (EM95), EMBASE Alert (EA08), SciSearch (IS90), Cochrane Library - CDSR (CDSR93), NHS-CRD-DARE (CDAR94), NHS-CRD-HTA (INAHTA), and NHS-EED (NHSEED). The present report included German and English literature published between the years 1999 and 2004. A list of the search parameters can be found in the appendix. No limits were placed on the target population, and the methodical quality of the included studies was determined using standardised checklists. Results: The studies included in this health technology assessment compared the following bypass materials: autologous vein, human umbilical vein (HUV) and synthetic materials such as PTFE or Dacron®. Both the systematic reviews and the randomised controlled trials comparing autologous vein grafts to other bypass materials come to the conclusion that autologous vein is superior to all other materials. From a medical viewpoint, there are no clear differences between the various synthetic materials.To date, the subject of bypass materials in vascular surgery has not been addressed comprehensively from an economic point of view. Indeed, we were able to identify only one publication that compared the cost of various bypass materials. The remaining health economic studies did not compare costs, cost effectiveness, or quality of life associated with the use of various bypass materials. Discussion: When deciding which bypass material to use, vascular surgeons take a number of medical considerations into account, including the bypass area, the availability of autologous vein, the amount of operation time available, and the health status of the patient. The studies included in this health technology assessment demonstrate that autologous vein is usually the preferred material for bypass grafts. In contrast, comparisons of various synthetic materials did not show any specific differences. It remains to be seen whether studies on newly developed synthetic materials will show these to have any particular advantages. The randomised controlled trials included in the present report were limited by a number of methodological weaknesses, such as different methods for determining patency rates, sample size and power problems, the interpretation of non-significant results, and a lack of consideration of additional factors. From an economic point of view, there is still great need for further research, and we have attempted to describe a number of pressing questions for health economic studies in the present report

Nachhaltige Vergütung der B-Zentren für Seltene Erkrankungen in Deutschland – Status quo und Lösungsansätze

Background: To ensure specialized care of patients with rare diseases, numerous centres for rare diseases were funded over the past few years. The reimbursement of patients’ ambulatory care in hospitals, however, is characterized by a plurality of forms of care and payment. There is some evidence of deficits in the reimbursement of care of patients suffering from a rare disease from studies on individual rare diseases. Objectives: To investigate current forms of care provision and reimbursement of centres for rare diseases and to develop future approaches for sustainable compensation. Materials and methods: Initially, centres for rare diseases in Germany were asked to provide information about their forms of care and reimbursement using questionnaires. Subsequently, two focus group interviews and one expert interview with representatives from centres for rare diseases, health insurance, health politics and patients were conducted to discuss current and future meritocratic forms of care provision and reimbursement. The data were evaluated using content analysis. Results and conclusions: Thirty-nine centres for rare diseases participated in the questionnaire survey. Of those, 38% receive a flat fee/allowance for university outpatient departments, the amount of which varies notably, and 41% obtain a mixed payment comprising an allowance for university outpatient departments and other forms of reimbursement. An under-recovery of costs in centres for rare diseases and its impact on patient care were mentioned in the interviews. In this context, a need to further develop forms of care provision and reimbursement has been identified. Participants prefer a special flat fee/allowance for rare diseases that covers the time-consuming care for patients with rare diseases. © 2022, The Author(s).Hintergrund: Um eine spezialisierte Versorgung von Menschen mit seltenen Erkrankungen (sE) zu gewährleisten, wurden zahlreiche Zentren für Seltene Erkrankungen (ZSE) gegründet. Für die ambulante Behandlung von Betroffenen in Krankenhäusern steht dabei eine Vielzahl von Versorgungs- und Vergütungsformen zur Verfügung. Studien zu einzelnen sE ergaben bereits Hinweise auf Defizite in Bezug auf eine kostendeckende Vergütung der ZSE. Ziel der Arbeit: Untersuchung der aktuellen Versorgungs- und Vergütungsstrukturen in den ZSE und die Entwicklung von Ansätzen für zukünftige nachhaltige Vergütungsstrukturen. Material und Methoden: Mittels Fragebogenerhebung wurden zunächst ZSE in Deutschland zu ihrer Versorgungs- und Vergütungsform befragt. Im Rahmen zweier Fokusgruppen- und eines Experteninterviews mit Vertreter:innen der ZSE, der Kostenträger, der Gesundheitspolitik sowie Patient:innen wurden im Anschluss die aktuellen Versorgungs- und Vergütungsformen, Möglichkeiten der zukünftigen Gestaltung der Versorgung von Menschen mit sE sowie Ansätze für eine leistungsorientierte Vergütung diskutiert. Das Material wurde inhaltsanalytisch nach Kuckartz ausgewertet. Ergebnisse und Diskussion: 39 Zentren beteiligten sich an der Fragebogenerhebung. 38 % dieser Zentren werden über eine Pauschale für Hochschulambulanzen (HSA) vergütet, deren Höhe stark variiert. 41 % weisen eine Mischvergütung aus HSA-Pauschale und weiteren Vergütungsformen auf. In den Interviews wurde eine Unterdeckung der Kosten in den ZSE mit Auswirkungen auf die Patientenversorgung benannt und zur Sicherstellung einer nachhaltigen Versorgung Handlungsbedarf zur Weiterentwicklung der Vergütungsstrukturen festgestellt. Eine „Sonderpauschale für sE“, die den besonderen zeitlichen Bedarf in der Versorgung von Menschen mit sE abbildet, wurde als möglicher nachhaltiger Vergütungsansatz präferiert

Dacron® vs. PTFE as bypass materials in peripheral vascular surgery – systematic review and meta-analysis

Roll S, Müller-Nordhorn J, Keil T, et al. Dacron® vs. PTFE as bypass materials in peripheral vascular surgery – systematic review and meta-analysis. BMC Surgery. 2008;8(1): 22.Background: In peripheral vascular bypass surgery different synthetic materials are available for bypass grafting. It is unclear which of the two commonly used materials, polytetrafluoroethylene (PTFE) or polyester (Dacron®) grafts, is to be preferred. Thus, the aim of this meta-analysis and systematic review was to compare the effectiveness of these two prosthetic bypass materials (Dacron® and PTFE). Methods: We performed a systematic literature search in MEDLINE, Cochrane-Library – CENTRAL, EMBASE and other databases for relevant publications in English and German published between 1999 and 2008. Only randomized controlled trials were considered for inclusion. We assessed the methodological quality by means of standardized checklists. Primary patency was used as the main endpoint. Random-effect meta-analysis as well as pooling data in life table format was performed to combine study results. Results: Nine randomized controlled trials (RCT) were included. Two trials showed statistically significant differences in primary patency, one favouring Dacron® and one favouring PTFE grafts, while 7 trials did not show statistically significant differences between the two materials. Meta-analysis on the comparison of PTFE vs. Dacron® grafts yielded no differences with regard to primary patency rates (hazard ratio 1.04 (95% confidence interval [0.85;1.28]), no significant heterogeneity (p = 0.32, I2 = 14%)). Similarly, there were no significant differences with regard to secondary patency rates. Conclusion: Systematic evaluation and meta-analysis of randomized controlled trials comparing Dacron® and PTFE as bypass materials for peripheral vascular surgery showed no evidence of an advantage of one synthetic material over the other

Prävention in Deutschland : eine Analyse aus ökonomischer Sicht

Leppert F. Prävention in Deutschland : eine Analyse aus ökonomischer Sicht. In: Eidt-Koch D, Prenzler A, von der Schulenburg J-M, eds. Steuerung des Gesundheitsverhaltens im Spannungsfeld zwischen staatlichem Paternalismus und individueller Freiheit. Schriftenreihe des Instituts für Versicherungsbetriebslehre der Universität Hannover, 15. Göttingen: Cuvillier; 2009: 107-130

Die Umsetzung des Nationalen Aktionsplans für Menschen mit seltenen Erkrankungen: Ergebnisse und Handlungsempfehlungen aus der wissenschaftlichen Begleitung

Seltene Erkrankungen stellen eine besondere Herausforderung für die Gesundheitsversorgung dar. Mit dem Nationalen Aktionsbündnis für Menschen mit Seltenen Erkrankungen wurde ein neuer Weg eingeschlagen, um die Versorgungssituation zu verbessern. Das Bündnis veröffentlichte 2013 einen Nationalen Aktionsplan. Im Rahmen der Evaluation wurden Umsetzungsstand, Steuerung und Arbeitsweise des Bündnisses sowie erste Effekte und Wirkungen der Aktivitäten untersucht. Die Ergebnisse zeigen, dass wichtige Erfolge erzielt werden konnten, bei den zentralen Themen jedoch weitere Anstrengungen notwendig sind

Cross-sectional validity of the EQ-5D-Y as a generic health outcome instrument in children and adolescents with cystic fibrosis in Germany

Eidt-Koch D, Mittendorf T, Greiner W. Cross-sectional validity of the EQ-5D-Y as a generic health outcome instrument in children and adolescents with cystic fibrosis in Germany. BMC Pediatrics. 2009;9(1):55.Background: Quality of life is recognized as an important additional outcome measure in clinical trials and health economic evaluations. The EQ-5D is an important generic health outcome instrument often used for economic evaluations as a complement with disease-specific outcome measures. In this study quality of life data was assessed using the EQ-5D-Y (new EQ-5D version for children and adolescents) and the Cystic Fibrosis Questionnaire (CFQ). The objective of the study is to evaluate the cross-sectional validity of the EQ-5D-Y as a generic health outcome instrument in children and adolescents with cystic fibrosis in Germany. Methods: In 2006 a multi-centre study was conducted in four cystic fibrosis centres in Germany. Quality of life data from 96 patients between eight and seventeen years was collected using the EQ-5D-Y as a generic outcome instrument and the Cystic Fibrosis Questionnaire (CFQ) as a disease-specific instrument. Results of both instruments were compared by statistical analyses using Spearman's rank correlations. Results: 44.6% of the patients stated that they had no problems in any of the EQ-5D-Y dimensions. Several low to high correlations between separate dimensions and the visual analogue scale of the EQ-5D-Y and the different scales of the CFQ for children, their parents and adolescents can be presented in this paper. Looking at the five EQ-5D-Y dimensions the highest correlation (rS = 0.625, p = 0.01) was found between the dimension 'mobility' and the CFQ scale 'physical functioning' in adolescent patients. The overall highest correlation was found between the 'subjective health perception' and the visual analogue scale (rS = 0.744, p = 0.01) in adolescent patients older than 13 years. Conclusion: The EQ-5D-Y can be considered a cross-sectional valid generic health outcome instrument which reflects differences in health according to the progression of the life-long chronic disease cystic fibrosis