TY - JOUR A1 - Icks, Andrea A1 - Chernyak, Nadja A1 - Bestehorn, Kurt A1 - Brüggenjürgen, Bernd A1 - Bruns, J. A1 - Damm, Oliver A1 - Dintsios, Charalabos-Markos A1 - Dreinhöfer, Karsten E. A1 - Gandjour, Afschin A1 - Gerber-Grote, Andreas A1 - Greiner, Wolfgang A1 - Hermanek, P. A1 - Hessel, Franz A1 - Heymann, Romy A1 - Huppertz, Eduard A1 - Jacke, Christian Olaf A1 - Kächele, H. A1 - Kilian, R. A1 - Klingenberger, D. A1 - Kolominsky-Rabas, P. A1 - Krämer, Heike U. A1 - Krauth, Christian A1 - Lüngen, M. A1 - Neumann, T. A1 - Porzsolt, Franz A1 - Prenzler, A. A1 - Pueschner, F. A1 - Riedel, R. A1 - Rüther, A. A1 - Salize, H. J. A1 - Scharnetzky, E. A1 - Schwerd, W. A1 - Selbmann, Hans Konrad A1 - Siebert, H. A1 - Stengel, Dirk A1 - Stock, Stephanie A1 - Völler, Heinz A1 - Wasem, Jürgen A1 - Schrappe, Martin T1 - Methoden der gesundheitsökonomischen Evaluation in der Versorgungsforschung JF - Das Gesundheitswesen N2 - Das Deutsche Netzwerk Versorgungsforschung e. V. (DNVF e. V.) hat am 30.08.2010 getragen von den genannten im DNVF organisierten Fachgesellschaften und Organisationen, das Memorandum III „Methoden für die Versorgungsforschung” Teil 2 verabschiedet, das in dieser Zeitschrift publiziert wurde [Gesundheitswesen 2010; 72: 739-748]. Die vorliegende Publikation fokussiert auf die Methodik der ökonomischen Evaluation der Gesundheitstechnologien bzw. Interventionen und stellt eine Vertiefung zu dem Memorandum III „Methoden für die Versorgungsforschung” Teil 2 dar. Zunächst werden allgemeine methodische Standards gesundheitsökonomischer Evaluationen, d. h. Studien, die die Kosten-Nutzen Relation (Wirtschaftlichkeit) von Interventionen untersuchen, kurz dargestellt. Um Versorgungsrealität adäquat zu reflektieren, müssen zur Ermittlung der Interventionskosten und -effekte oft mehrere Datenquellen, z. B. Wirksamkeitsstudien, Register, administrative Quellen usw., verwendet werden. Daher werden für die gesundheitsökonomischen Evaluationen im Rahmen der Versorgungsforschung potenziell geeignete Datenquellen vorgestellt, ihre Vorteile und Limitationen genannt. Anschließend wird der Weiterentwicklungsbedarf der Methodik im Hinblick auf die Datenerhebung, und -auswertung sowie die Kommunikation und Dissemination der Ergebnisse diskutiert. KW - Gesundheitsökonomie KW - Ökonomische Evaluation KW - Versorgungsforschung Y1 - 2010 N1 - Online: https://www.researchgate.net/publication/46414905_Methoden_der_gesundheitsokonomischen_Evaluation_in_der_Versorgungsforschung VL - 72 IS - 12 SP - 917 EP - 933 ER - TY - JOUR A1 - Moock, Jörn A1 - Hessel, Franz A1 - Ziegeler, Diana A1 - Kubiak, Thomas A1 - Kohlmann, Thomas T1 - Development and Validation of the Insulin Treatment Experience Questionnaire (ITEQ) JF - The Patient N2 - Objectives: To develop and psychometrically evaluate a domain-specific questionnaire to assess subtle but clinically relevant differences in treatment experiences and satisfaction over a wide range of currently available insulin therapy regimens. The study focussed on patients with type 2 diabetes mellitus and placed particular attention on the impact of different forms of insulin therapy on diabetes self-management. Methods: The development of the Insulin Treatment Experience Questionnaire (ITEQ) was conducted in three steps: (i) a qualitative phase to generate relevant items and identify relevant domains; (ii) a pilot study to reduce the number of generated items; and (iii) a validation study to assess major psychometric properties of the final ITEQ version. Results: The final version of the questionnaire comprised 28 items with the subscales ‘leisure activities’ (four items), ‘psychological barriers’ (two items), ‘handling’ (five items), ‘diabetes control’ (six items), ‘dependence’ (five items), ‘weight control’ (three items), ‘sleep’ (two items), and one further item assessing general treatment satisfaction. The subscales’ internal consistencies (Cronbach’s alpha) ranged from 0.52 to 0.83. Motivated by the homogenous structure of inter-scale-correlations (range 0.10–0.46), a summary composite score was calculated (alpha = 0.86). Construct validity showed statistically significant correlations with other scales (ITEQ vs the Problem Areas in Diabetes [PAID] questionnaire total score −0.60, ITEQ vs the Diabetes Treatment Satisfaction Questionnaire [DTSQ] total score 0.52). Conclusion: The newly developed ITEQ displayed satisfactory to good psychometric properties, thereby allowing the assessment of everyday life experience and treatment satisfaction in patients with insulin-treated type 2 diabetes. Additional research is needed to assess test-retest reliability and sensitivity to change. KW - Diabetis Self-Management KW - Diabetis Mellitus Y1 - 2010 N1 - Online: https://www.researchgate.net/publication/233507832_Development_and_Testing_of_the_Insulin_Treatment_Experience_Questionnaire_ITEQ VL - 3 IS - 1 SP - 45 EP - 58 ER - TY - JOUR A1 - Hessel, Franz A1 - Bramlage, Peter A1 - Wasem, Jürgen A1 - Mitzner, Steffen R. T1 - Cost effectiveness of the artifical liver support system MARS in patients with acute-on-chronic liver failure JF - European Journal of Gastroenterology & Hepatology N2 - For patients with an acute exacerbation of chronic liver failure (ACLF), the molecular adsorbent recirculating system (MARS) can result in a prolongation of life, but data on costs and cost-effectiveness are lacking. A health economic evaluation of a prospective controlled cohort trial in patients with ACLF not eligible for liver transplantation with 3 years follow-up and consecutive modelling of long-term costs, outcomes and cost-effectiveness was conducted. Costs were calculated from the perspective of the German health-care system. One hundred and forty-nine patients with ACLF were included of which 67 (44.9%) were treated with MARS and 82 (55.1%) assigned to the control group. Mean survival was 692 days in MARS-treated patients (33% survival after 3 years) and 453 days in control patients (15% after 3 years, logrank P = 0.022). MARS patients gained 0.66 [95% confidence interval (CI): -0.12 to 1.46] life years (LYs), determined by the bootstrap method. The mean cost difference was 19.835 euro (95% CI: 13.308-25.429) with 35639 euro for MARS-treated patients and 15804 euro for controls. Incremental costs per LY gained were 29.985 euro (95% CI: 9.441-321.761) and 43.040 euro (95% CI: 13.551-461.856) per quality-adjusted LY gained. There is an acceptable cost-effectiveness of MARS, compared with other medical technologies presently reimbursed. Randomized controlled trials with sufficient sample size are necessary before a final recommendation for MARS can be given. KW - Health Economics KW - Cost Benefit Analysis Y1 - 2010 N1 - Online: https://www.researchgate.net/publication/26830926_Cost-effectiveness_of_the_artificial_liver_support_system_MARS_in_patients_with_acute-on-chronic_liver_failure VL - 22 IS - 2 SP - 213 EP - 220 ER - TY - JOUR A1 - Reinhold, Thomas A1 - Brüggenjürgen, Bernd A1 - Schlander, Michael A1 - Rosenfeld, Stephanie A1 - Hessel, Franz A1 - Willich, Stefan N. T1 - Economic analysis based on multinational studies: methods for adapting findings to national contexts JF - Journal of Public Health N2 - Background: Health economic parameters are increasingly considered as variables in health care decisions, but decision makers are interested in country-specific evaluations. However, a large number of studies are performed in foreign countries or in a multinational setting, which limits the transferability to a single nation’s context. Objective: The present analysis summarises several of the most common international methods for generating health economic analyses based on clinical studies from different settings. Methods: A narrative literature review was performed to identify potential reasons for limited transferability of health economic evaluation results from one country to another. Based on these results, we searched the methodological literature for analytic approaches to handle the restrictions. Additionally we describe the possibility of transferring foreign economic study results to the country of interest by matching trial data with routine data of national databases. Results: The main factors for limited transferability of health economic findings were found in country-specific differences in resource consumption and the resulting costs. These differences are affected by a number of influencing cofactors (demography, epidemiology and individual patient’s factors) and the overall health care system structures (e.g. payment systems, health provider incentives). However, despite the limitations country-specific health economic assessments could be realised using the pooled/split analyses approach, some statistical approaches and modelling approaches. Conclusion: A variety of methods for identifying and adjusting country-specific differences in costs, effects and cost-effectiveness was established during the past decades. Multinational studies will continue to play a crucial role in the evaluation of cost-effectiveness at national levels. It seems likely that the growing interest in multinational studies will lead to continued developments in adaptation methods. KW - International Adaption KW - Cost-Effectiveness KW - Economic Evaluation Y1 - 2010 N1 - Online: https://www.ssoar.info/ssoar/handle/document/20369 VL - 18 IS - 4 SP - 327 EP - 335 ER - TY - JOUR A1 - Neumann, Anja A1 - Jahn, Rebecca A1 - Diehm, Curt A1 - Driller, Elke A1 - Hessel, Franz A1 - Ommen, Oliver A1 - Pfaff, Holger A1 - Siebert, Uwe A1 - Pittrow, David A1 - Wasem, Jürgen T1 - Outcomes of medical management of peripheral arterial disease in general practice: follow-up results of the PACE-PAD Study JF - Journal of Public Health N2 - Peripheral arterial disease (PAD), a marker of elevated vascular risk, is highly prevalent in general practice. We aimed to investigate patient characteristics and outcomes of PAD patients treated according to the guidelines versus those who were not. Methods. PACE-PAD was a multicentre, cluster - randomised prospective, longitudinal cohort study of patients with PAD in primary care, who were followed-up for death or vascular events over 18 months. Guideline-orientation was assumed, if patients received anti¬coagu¬lant/antiplatelet therapy, exercise training, and (if applicable) advice for smoking cessation and therapy of diabetes mellitus, hypertension, or hypercholesterolemia, respectively. Results. The 5099 PAD patients (mean age 68.0 ± 9.0 years, 68.5% males) who were followed-up were in Fontaine stages I, IIa, IIb, III, and IV in 22.5%, 34.6%, 30.1%, 7.8%, and 3.5% (1.5% not specified). Comprehensive guideline orientation was reported in 28.4% only, however, patients in lower Fontaine stages received more often guideline-oriented therapy (I: 30.3%; IIa: 31.6%, IIb: 29.1%, III: 9.8%, IV: 18.0%). During 18 months, 457 patients died (224 due to cerebrovascular or coronary deaths), 319 had instable angina pectoris, 116 myocardial infarction, and 140 an ischemic stroke event. In total, 24% of patients had experienced any vascular event (19.1% a first event). Event rates did not differ between patients treated according to guidelines, and those who were not. Conclusion. The present PAD cohort was a high-risk sample with an unexpectedly high rate of deaths and vascular events. While physicians appear to focus on the treatment of individual risk factors, rates of comprehensive PAD management in line with guideline recommendations are still suboptimal. Factors contributing to the lacking difference between outcomes in the guideline-oriented and non-guideline-oriented groups may comprise low treatment intensity or other reasons for unsatisfactory effect of treatment, misclassification of events, patient's non-compliance with therapy. KW - Guideline Orientation KW - Peripheral Arterial Disease KW - Observational Study Y1 - 2010 N1 - Online: https://www.ssoar.info/ssoar/handle/document/23313 VL - 18 SP - 523 EP - 532 ER -