@article{IcksChernyakBestehornetal.2010, author = {Icks, Andrea and Chernyak, Nadja and Bestehorn, Kurt and Br{\"u}ggenj{\"u}rgen, Bernd and Bruns, J. and Damm, Oliver and Dintsios, Charalabos-Markos and Dreinh{\"o}fer, Karsten E. and Gandjour, Afschin and Gerber-Grote, Andreas and Greiner, Wolfgang and Hermanek, P. and Hessel, Franz and Heymann, Romy and Huppertz, Eduard and Jacke, Christian Olaf and K{\"a}chele, H. and Kilian, R. and Klingenberger, D. and Kolominsky-Rabas, P. and Kr{\"a}mer, Heike U. and Krauth, Christian and L{\"u}ngen, M. and Neumann, T. and Porzsolt, Franz and Prenzler, A. and Pueschner, F. and Riedel, R. and R{\"u}ther, A. and Salize, H. J. and Scharnetzky, E. and Schwerd, W. and Selbmann, Hans Konrad and Siebert, H. and Stengel, Dirk and Stock, Stephanie and V{\"o}ller, Heinz and Wasem, J{\"u}rgen and Schrappe, Martin}, title = {Methoden der gesundheits{\"o}konomischen Evaluation in der Versorgungsforschung}, series = {Das Gesundheitswesen}, volume = {72}, journal = {Das Gesundheitswesen}, number = {12}, pages = {917 -- 933}, year = {2010}, abstract = {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 f{\"u}r die Versorgungsforschung" Teil 2 verabschiedet, das in dieser Zeitschrift publiziert wurde [Gesundheitswesen 2010; 72: 739-748]. Die vorliegende Publikation fokussiert auf die Methodik der {\"o}konomischen Evaluation der Gesundheitstechnologien bzw. Interventionen und stellt eine Vertiefung zu dem Memorandum III „Methoden f{\"u}r die Versorgungsforschung" Teil 2 dar. Zun{\"a}chst werden allgemeine methodische Standards gesundheits{\"o}konomischer Evaluationen, d. h. Studien, die die Kosten-Nutzen Relation (Wirtschaftlichkeit) von Interventionen untersuchen, kurz dargestellt. Um Versorgungsrealit{\"a}t ad{\"a}quat zu reflektieren, m{\"u}ssen zur Ermittlung der Interventionskosten und -effekte oft mehrere Datenquellen, z. B. Wirksamkeitsstudien, Register, administrative Quellen usw., verwendet werden. Daher werden f{\"u}r die gesundheits{\"o}konomischen 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.}, language = {de} } @misc{Hessel2012, author = {Hessel, Franz}, title = {Prozessmanagement in Krankenh{\"a}usern in Deutschland}, year = {2012}, abstract = {Keine Angabe No details}, language = {de} } @inproceedings{Hessel2012, author = {Hessel, Franz}, title = {Economic Analysis of Thromboprophylaxis With Rivaroxaban and Certoparin-Sodium in Patients After Total Hip or Knee Replacement}, series = {ISPOR 15th Annual European Congress, Berlin}, booktitle = {ISPOR 15th Annual European Congress, Berlin}, year = {2012}, abstract = {Keine Angabe - No details}, language = {en} } @misc{Hessel2012, author = {Hessel, Franz}, title = {Die Notwendigkeit von Routinedaten in der Versorgungsforschung: Bedarf, Perspektiven und Potentiale}, year = {2012}, abstract = {Keine Angabe - No details}, language = {de} } @article{NoweskiWalendzikHesseletal.2013, author = {Noweski, Michael and Walendzik, Anke and Hessel, Franz and Jahn, Rebecca and Wasem, J{\"u}rgen}, title = {Zulassung und Erstattung personalisierter Arzneimittel: Zwischenbilanz des Anpassungsprozesses}, series = {Ethik in der Medizin}, volume = {25}, journal = {Ethik in der Medizin}, number = {3}, pages = {277 -- 284}, year = {2013}, abstract = {Die Arzneimittelzulassung und der Aufnahmeprozess zur Kostenerstattung sollen die Entwicklung und Vermarktung von pharmazeutischen Innovationen mit Patientennutzen nicht behindern, zugleich aber die Wirtschaftlichkeit der Arzneimittelversorgung f{\"u}r die Kostentr{\"a}ger nicht gef{\"a}hrden. Eine Anpassung der Verfahren an die Merkmale personalisierter Arzneimittel erscheint notwendig. Dabei ist allerdings zu fragen, ob eine ungerechtfertigte Privilegierung erfolgt. In den USA und in der EU werden die jeweiligen Zulassungsverfahren f{\"u}r Arzneimittel und Tests schrittweise angepasst und integriert. Zulassung und Erstattungsentscheidungen sollen koordiniert werden. Eine Privilegierung, wie bei Arzneimitteln f{\"u}r seltene Indikationen (Orphan Drugs), findet jedoch f{\"u}r personalisierte Medizin nicht statt. Es bestehen keine unzumutbaren H{\"u}rden f{\"u}r die Hersteller. Zur{\"u}ckhaltung bei der Entwicklung innovativer Produkte w{\"a}re deshalb nicht gerechtfertigt.}, language = {de} } @incollection{HesselBiermannKerkemeyeretal.2013, author = {Hessel, Franz and Biermann, Janine and Kerkemeyer, Linda and Korff, Lasse and Mostardt, Sarah and Neumann, Anja}, title = {Arzneimittelversorgung}, series = {Medizinmanagement: Grundlagen und Praxis}, booktitle = {Medizinmanagement: Grundlagen und Praxis}, editor = {Wasem, J{\"u}rgen}, publisher = {Medizinisch Wissenschaftliche Verlagsgesellschaft}, address = {Berlin}, publisher = {SRH Berlin University of Applied Sciences}, pages = {355 -- 391}, year = {2013}, abstract = {Keine Angabe - No details}, language = {de} } @article{Hessel2013, author = {Hessel, Franz}, title = {Personalized Medicines: worth the Effort and Investment?}, series = {Pharmaceutical Executive}, volume = {11}, journal = {Pharmaceutical Executive}, url = {http://nbn-resolving.de/urn:nbn:de:0298-opus4-5479}, pages = {2 -- 6}, year = {2013}, abstract = {Prof. Dr. Franz Hessel questions whether personalized medicine and companion diagnostics are actually enhancing the drug development process.}, language = {en} } @inproceedings{Hessel2013, author = {Hessel, Franz}, title = {The relevance of the analytic validity of genetic tests in personalized medicine technologies for reimbursement decision making in Germany}, series = {EACME Annual Conference, Bochum}, booktitle = {EACME Annual Conference, Bochum}, year = {2013}, abstract = {Keine Angabe - No details}, language = {en} } @inproceedings{Hessel2013, author = {Hessel, Franz}, title = {Developing personalized medicine drugs: incentives for pharmaceutical companies}, series = {EACME Annual Conference, Bochum}, booktitle = {EACME Annual Conference, Bochum}, year = {2013}, abstract = {Objectives: Stratification of oncology drug therapy by genetic marker diagnostics can reveal additional patient benefit but also might influence the development process of drug manufacturers. The objective of this study is to identify and describe the most important incentives for pharmaceutical companies to develop personalized medicine drugs. Methods: To describe the main factors influencing the decision making process in the development of personalized medicine drugs we designed a qualitative systemdynamic model. The main factors influencing the process and their priority ranking were determined by systematic literature search, structured expert interviews with pharmaceutical companies, test manufacturers and other key stakeholders such as regulatory bodies, reimbursement decision makers and payers. The model was build with the Consideo iModeler software package. Results: In contrast to small companies big international companies constantly look for suitable companion diagnostic tests to select subgroups of high responder. The most important key factor for market success is the extent of clinical efficacy in comparison with competitors respectively the current treatment standard. Stratification of patient populations according to treatment response or frequency of adverse events using biomarker is regarded to increase clinical efficacy of the target indication. The test performance is important due to unsolved safety issues although not regarded as crucial for the success of the drug. In contrast to other stakeholders pharmaceutical companies did not consider personalized medicine to relevantly decrease development costs or marketing efforts respectively to increase the price potential for new drugs. A low prevalence of the remaining patient population after testing is not irrelevant but it is not seen as a factor which might lead to a stop of the development of a new drug by pharmaceutical companies. Conclusions: Genetic stratification is seen as a breakthrough in cancer therapy by pharmaceutical companies and physicians. Due to the current need for improvement of approval and reimbursement processes for personalized medicine approaches in oncology especially in Europe future sales are more difficult to predict.}, language = {en} } @inproceedings{Hessel2013, author = {Hessel, Franz}, title = {Gesundheits{\"o}konomische Analyse der Thromboseprophylaxe mit Ribaroxaban im Vergleich zu Certoparin nach H{\"u}ft- und Kniegelenks-Endoprothesen-Operation aus Sicht einer Universit{\"a}tsklinik}, series = {Jahrestagung der Deutschen Gesellschaft f{\"u}r Gesundheits{\"o}konomie (DGG{\"O}), Essen}, booktitle = {Jahrestagung der Deutschen Gesellschaft f{\"u}r Gesundheits{\"o}konomie (DGG{\"O}), Essen}, year = {2013}, abstract = {Keine Angabe - No details}, language = {de} } @inproceedings{Hessel2013, author = {Hessel, Franz}, title = {Die Machbarkeit der Erhebung der Zahlungsbereitschaft {\"u}ber soziale Netzwerke am Beispiel von Darmkrebs-Screening}, series = {Jahrestagung der Deutschen Gesellschaft f{\"u}r Gesundheits{\"o}konomie (DGG{\"O}), Essen}, booktitle = {Jahrestagung der Deutschen Gesellschaft f{\"u}r Gesundheits{\"o}konomie (DGG{\"O}), Essen}, year = {2013}, abstract = {Zielsetzung: Die Zielsetzung der vorliegenden Studie war es, die Machbarkeit der Erhebung der Zahlungsbereitschaft {\"u}ber soziale Netzwerke, hier Facebook, am Beispiel des Darmkrebs-Screenings zu untersuchen. Bei dem beschriebenen neuen diagnostischen Test handelt es sich um den neuartigen molekularen Bluttest Septin9, der im Vergleich zu standardm{\"a}ssig f{\"u}r Routinescreening auf Darmkrebs eingesetzten Test auf okkultes Blut im Stuhl (FOBT) eine bessere Performance, eine bessere Handhabbarkeit und eine bessere Compliance von Patienten und {\"A}rzten aufweist. Methodik: Es wurden Informationen zum Krankheitsbild und den alternativen Screeningmethoden f{\"u}r Darmkrebs gegeben. Die Zahlungsbereitschaft wurde in bin{\"a}ren Kategorien (<100 oder >100 EUR) und als H{\"o}chstbetrag erfasst. Die weiteren Parameter wie Alter, Geschlecht, Versicherten- und Einkommensstatus, Ern{\"a}hrung, Kontakt mit Krebserkrankungen und gesundheitsbewusstes Verhalten (Alkohol, Rauchen) wurden in Kategorien erfasst. Die Befragung wurde von sechs Facebook-Accounts an insgesamt rund 500 Nutzer des sozialen Netzwerks mit der M{\"o}glichkeit der weiteren Distribution versandt. Die Beantwortung eines Kern-Teils der Fragen wurde als Bedingung f{\"u}r die anonyme Einsendung {\"u}ber einen Dropbox-Link vorausgesetzt. Der R{\"u}cklaufzeitraum betrug 14 Tage. Ergebnisse: Es gingen 123 komplett ausgef{\"u}llte Frageb{\"o}gen ein. Die Teilnehmer waren im Schnitt 24,2 Jahre und verdienen zu 94 \% weniger als 1500 EUR monatlich. 27 \% der Teilnehmer sind privat versichert. 68\% gaben an in der Familie von Krebs betroffen zu sein und 36 \%, dass sie sich der Gefahr von Darmkrebs bewusst sind. Die Angaben zum wichtigsten Attribut eines Screening-Tests verteilten sich folgendermaßen: 69 \% Testgenauigkeit, 14 \% Handling, 11 \% Preis und 6\% Schnelligkeit des Ergebnisses. 24 \% gaben eine Zahlungsbereitschaft von weniger als 100 EUR an (Mittelwert 34 EUR), 76 \% waren bereit mehr als 100 EUR zu bezahlen. Die durchschnittliche Zahlungsbereitschaft lag bei 271 EUR. Ein h{\"o}heres Einkommen, eine Krebserkrankung in der Familie und ein Privatversichertenstatus waren mit einer h{\"o}heren Zahlungsbereitschaft korreliert. Schlussfolgerung: Eine Messung der Zahlungsbereitschaft sowie weiterer die Patientenpr{\"a}ferenzen beschreibender Variablen ist {\"u}ber soziale Netzwerke mit vergleichsweise geringem Aufwand m{\"o}glich. Vorteile liegen in der Freiwilligkeit und der Anonymit{\"a}t der Erhebung, wodurch direkte, nicht standardisierte Beeinflussungsm{\"o}glichkeiten w{\"a}hrend der Befragung als Bias wegfallen. Nachteile liegen in der sicherlich starken Selektion der Zielgruppe, was zu einer Einschr{\"a}nkung der Anwendbarkeit der Methode f{\"u}hrt.}, language = {de} } @misc{Hessel2012, author = {Hessel, Franz}, title = {Gesundheitsmanagement}, year = {2012}, abstract = {Keine Angabe No details}, language = {de} } @article{MoockHesselZiegeleretal.2010, author = {Moock, J{\"o}rn and Hessel, Franz and Ziegeler, Diana and Kubiak, Thomas and Kohlmann, Thomas}, title = {Development and Validation of the Insulin Treatment Experience Questionnaire (ITEQ)}, series = {The Patient}, volume = {3}, journal = {The Patient}, number = {1}, pages = {45 -- 58}, year = {2010}, abstract = {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.}, language = {en} } @article{HesselBramlageWasemetal.2010, author = {Hessel, Franz and Bramlage, Peter and Wasem, J{\"u}rgen and Mitzner, Steffen R.}, title = {Cost effectiveness of the artifical liver support system MARS in patients with acute-on-chronic liver failure}, series = {European Journal of Gastroenterology \& Hepatology}, volume = {22}, journal = {European Journal of Gastroenterology \& Hepatology}, number = {2}, pages = {213 -- 220}, year = {2010}, abstract = {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.}, language = {en} } @article{ReinholdBrueggenjuergenSchlanderetal.2010, author = {Reinhold, Thomas and Br{\"u}ggenj{\"u}rgen, Bernd and Schlander, Michael and Rosenfeld, Stephanie and Hessel, Franz and Willich, Stefan N.}, title = {Economic analysis based on multinational studies: methods for adapting findings to national contexts}, series = {Journal of Public Health}, volume = {18}, journal = {Journal of Public Health}, number = {4}, pages = {327 -- 335}, year = {2010}, abstract = {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.}, language = {en} } @misc{Hessel2012, author = {Hessel, Franz}, title = {Knorpelzellentransplantation aus Sicht der Gesundheits{\"o}konomie und Versorgungsforschung}, year = {2012}, abstract = {Keine Angabe No details}, language = {de} } @misc{Hessel2012, author = {Hessel, Franz}, title = {Verg{\"u}tung personalisierter Medizin}, year = {2012}, abstract = {Keine Angabe No details}, language = {de} } @misc{Hessel2012, author = {Hessel, Franz}, title = {Gesundheits{\"o}konomische Betrachtung kongenitaler Cytomegalie-Virus Infektionen}, year = {2012}, abstract = {Keine Angabe No details}, language = {de} } @misc{Hessel2012, author = {Hessel, Franz}, title = {Gesundheits{\"o}konomische Evaluation nicht nur f{\"u}r Arzneimittel: Diagnostika und Medizinprodukte}, year = {2012}, abstract = {Keine Angaben No details}, language = {de} } @misc{Hessel2012, author = {Hessel, Franz}, title = {Gesundheits{\"o}konomische Studien auf der Basis von Registerdaten}, year = {2012}, abstract = {Keine Angaben No details}, language = {de} } @misc{Hessel2012, author = {Hessel, Franz}, title = {Qualit{\"a}t der Versorgung von Substitutionspatienten anhand der Premos-Studie}, year = {2012}, abstract = {Keine Angabe No details}, language = {de} } @misc{Hessel2012, author = {Hessel, Franz}, title = {Auswirkungen des demografischen Wandels auf die Arbeitssituation von {\"A}rzten und Pflegekr{\"a}ften}, year = {2012}, abstract = {Keine Angabe No details}, language = {de} } @misc{Hessel2012, author = {Hessel, Franz}, title = {Aktuelle Aspekte der Pharma-{\"O}konomie}, year = {2012}, abstract = {Keine Angabe No details}, language = {de} } @article{NeumannJahnDiehmetal.2010, author = {Neumann, Anja and Jahn, Rebecca and Diehm, Curt and Driller, Elke and Hessel, Franz and Ommen, Oliver and Pfaff, Holger and Siebert, Uwe and Pittrow, David and Wasem, J{\"u}rgen}, title = {Outcomes of medical management of peripheral arterial disease in general practice: follow-up results of the PACE-PAD Study}, series = {Journal of Public Health}, volume = {18}, journal = {Journal of Public Health}, pages = {523 -- 532}, year = {2010}, abstract = {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.}, language = {en} } @article{GlasbergHartmannDraheimetal.2014, author = {Glasberg, Ronald and Hartmann, Michael and Draheim, Michael and Tamm, Gerrit and Hessel, Franz}, title = {Risks and Crises for Healthcare Providers: the Impact of Cloud Computing}, series = {The Scientific World Journal}, journal = {The Scientific World Journal}, url = {http://nbn-resolving.de/urn:nbn:de:0298-opus4-9695}, year = {2014}, abstract = {We analyze risks and crises for healthcare providers and discuss the impact of cloud computing in such scenarios. The analysis is conducted in a holistic way, taking into account organizational and human aspects, clinical, IT-related, and utilities-related risks as well as incorporating the view of the overall risk management.}, language = {en} } @article{Hessel, author = {Hessel, Franz}, title = {Budget impact of computer-based psychotherapy in Germany}, series = {Value in Health}, journal = {Value in Health}, abstract = {Keine Angabe No details}, language = {en} } @article{Hessel2015, author = {Hessel, Franz}, title = {Genetisch stratifizierende Medizin in der Onkologie}, series = {Blickpunkte Mensch Gesellschaft Sicherheit}, journal = {Blickpunkte Mensch Gesellschaft Sicherheit}, number = {4}, pages = {10 -- 12}, year = {2015}, abstract = {Keine Angabe - No details}, language = {de} } @incollection{Hessel2015, author = {Hessel, Franz}, title = {The Relevance of the Analytic Validity of Genetic Biomarker Tests in Personalised Medicine in Oncology}, series = {The Ethics Personalised Medicine}, booktitle = {The Ethics Personalised Medicine}, publisher = {Ashgate}, address = {Farnham}, publisher = {SRH Berlin University of Applied Sciences}, pages = {187 -- 208}, year = {2015}, abstract = {A crucial attribute of genetically stratifying personalised medicine technologies is the combination of a biomarker test (or a set of more than one) and a therapeutic decision which is made according to the test results. The biomarker test - often called a 'companion diagnostic' - is an essential part of the personalised medicine treatment strategy. The US FDA (Food and Drug Administration) approval agency even stated in a recent reflection paper that it would not approve a new drug without the companion biomarker test if a marker is known (FDA, 2011).}, language = {en} } @incollection{NoweskiWalendzikHesseletal.2015, author = {Noweski, Michael and Walendzik, Anke and Hessel, Franz and Jahn, Rebecca and Wasem, J{\"u}rgen}, title = {Approval and Reimbursement of Personalised Drugs: Interim Results of the Adjustment Process}, series = {The Ethics of Personalised Medicine}, booktitle = {The Ethics of Personalised Medicine}, publisher = {Ashgate}, address = {Farnham}, publisher = {SRH Berlin University of Applied Sciences}, pages = {199 -- 209}, year = {2015}, abstract = {According to drug manufacturers, the pharmaceutical industry is suffering from an 'innovation crisis'. Nowadays, the development of new products requires significantly more investment than in the past. Most of the simple but useful chemical entities seem to have been discovered already. Moreover, many topselling drugs lose their patent protection ('patent cliff ') and, subsequently, prices and sales of the original drug are undermined by competing generics. Producers try to compensate for the loss of sales by launches of new molecular entities (Jimenez, 2012). However, the new compounds generate fewer sales. As market observers calculated, new products launched in the period from 2001 to 2005 achieved annual average sales of USD 208 million after three years. New products of the period from 2006 to 2010 reached only USD 143 million (Rockoff and Winslow, 2013). Development of a drug which yields more than a billion USD per year ('blockbuster') succeeds less often. Drugs combined with biomarker-based diagnostic tests, stratifying patients into groups characterised by different drug reactions, appear to be one way out of trouble, because a new generation of patented products seems attainable (Scollen and Phelan, 2014).}, language = {en} } @incollection{SchildmannBoettcherGabrieletal.2015, author = {Schildmann, Jan and B{\"o}ttcher, Miriam and Gabriel, Maria and Ganser, Arnold and Hessel, Franz and Gottwald, Sina}, title = {"Personalised medicine": Multidisciplinary perspectives and interdisciplinary recommendations on a framework for future research and practice}, series = {The Ethics of Personalised Medicine}, booktitle = {The Ethics of Personalised Medicine}, publisher = {Ashgate}, address = {Farnham}, publisher = {SRH Berlin University of Applied Sciences}, pages = {keine Angabe -- keine Angabe}, year = {2015}, abstract = {'Personalised medicine' (PM) has raised great hopes and expectations among researchers, patients, health-care providers and politicians in past years. Although the term 'person' in PM suggests an approach of medicine which takes into account psychosocial and value aspects of the patient as human being, most articles refer to PM as strategies limited to biological features of individuals which are used to stratify patient groups for the purposes of prevention, diagnosis and treatment of disease.}, language = {en} } @incollection{Hessel2015, author = {Hessel, Franz}, title = {HTA in Personalized Medicine Technologies}, series = {Biomarker Validation}, booktitle = {Biomarker Validation}, publisher = {Wiley-VCH}, address = {Weinheim}, publisher = {SRH Berlin University of Applied Sciences}, pages = {95 -- 106}, year = {2015}, abstract = {Beyond the proof of efficacy and safety for approval purposes health technology assessment (HTA) is a more comprehensive evaluation of all relevant short- and long-term consequences of the application of a specific medical technology. HTA is performed for the purpose of reimbursement decision making. It covers clinical, societal, economic, ethical and legal aspects based on the available scientific evidence. Although there are some special issues to be considered all principles of HTA are equally valid for the evaluation of biomarker tests and personalized medicine technologies. All requirements of evidence-based medicine remain and causality should and could only be demonstrated with high-quality controlled studies, preferably with randomized design. The multimodality of the intervention and by tendency smaller sample sizes lead to an increased amount of uncertainty. Besides the test strategy, itself also questions of test or sample quality, laboratory size, or the platform used, and the specific technology must be taken into consideration. Economic evaluations should also include these aspects. In summary the fundamental principles of HTA and health economic evaluation are also valid and feasible for the evaluation of personalized medicine and genetic biomarker tests, but careful adaptations of the existing HTA and health economic guidelines are required.}, language = {en} } @article{HesselPfeifferGerschelReimer2014, author = {Hessel, Franz and Pfeiffer-Gerschel, Tim and Reimer, Jens}, title = {Die Qualit{\"a}t in der Versorgung Opiatabh{\"a}ngiger in substitutionsgest{\"u}tzter Behandlung: eine Diskussion vor dem Hintergrund der PREMOS-Studie}, series = {Suchttherapie}, volume = {15}, journal = {Suchttherapie}, number = {2}, pages = {84 -- 90}, year = {2014}, abstract = {Keine Angabe - No details}, language = {de} } @article{HesselFreckmannResch2014, author = {Hessel, Franz and Freckmann, Guido and Resch, Ansgar}, title = {Konsequenzen der Genauigkeit von Blutglucosemesssystemen: klinische und {\"o}konomische Aspekte}, series = {Der Diabetologe}, volume = {10}, journal = {Der Diabetologe}, number = {1}, pages = {26 -- 35}, year = {2014}, abstract = {Hintergrund Trotz vorgegebener Qualit{\"a}tsstandards sind Unterschiede in der Messgenauigkeit kommerziell erh{\"a}ltlicher Blutglucosemesssysteme zu beobachten. Ziel der Arbeit Die vorliegende Analyse wurde mit dem Ziel durchgef{\"u}hrt, die klinischen und {\"o}konomischen Konsequenzen der auf Messungenauigkeiten beruhenden Fehler von Blutglucosemesssystemen f{\"u}r Patienten mit Diabetes, die eine intensivierte konventionelle Insulintherapie (ICT) durchf{\"u}hren, modellhaft abzusch{\"a}tzen. Material und Methode Ein internationales Simulationsmodell wurde auf die deutsche Situation adaptiert. Auf der Basis publizierter, systemspezifischer Evaluierungen der Messg{\"u}te von 5 kommerziell erh{\"a}ltlichen Blutglucosemesssystemen wurde das Risiko ermittelt, zus{\"a}tzliche Hypoglyk{\"a}mien aufgrund fehlerhafter Blutglucosemessungen zu entwickeln. Aus anderen Studien wurde die H{\"a}ufigkeit hypoglyk{\"a}miebedingter medizinischer Leistungen abgeleitet, und die dadurch bedingten Kosten f{\"u}r das deutsche Gesundheitssystem wurden kalkuliert. Ergebnisse Die Modellsimulationen ergaben maximale Zahlen von rund 63.000 (Typ-1-Diabetes, T1DM) und 56.000 (Typ-2-Diabetes, T2DM) zus{\"a}tzlichen schweren Hypoglyk{\"a}mien, die durch Unterschiede in der Messgenauigkeit der Blutglucosemesssysteme bedingt sind. Bezogen auf die Gesamtzahl der Patienten in Deutschland, die nach Kenntnis der Autoren eine ICT durchf{\"u}hren, ergeben sich dadurch j{\"a}hrliche zus{\"a}tzliche direkte medizinische Kosten von rund 27,8 Mio. € f{\"u}r Patienten mit T1DM bzw. rund 30,0 Mio. € f{\"u}r Patienten mit T2DM. Schlussfolgerung Die Analyse belegt, dass Unterschiede in der Messgenauigkeit zu relevanten klinischen und {\"o}konomischen Konsequenzen f{\"u}hren k{\"o}nnen.}, language = {de} } @article{ReinholdWillichHesseletal.2011, author = {Reinhold, Thomas and Willich, Stefan and Hessel, Franz and Br{\"u}ggenj{\"u}rgen, Bernd}, title = {Die Nutzung von Routinedaten der gesetzlichen Krankenkassen (GKV) zur Beantwortung gesundheits{\"o}konomischer Fragestellungen: eine Potenzialanalyse}, series = {Gesundheits{\"o}konomie \& Qualit{\"a}tsmanagement}, volume = {16}, journal = {Gesundheits{\"o}konomie \& Qualit{\"a}tsmanagement}, number = {3}, publisher = {Georg Thieme Verlag}, address = {Stuttgart}, pages = {153 -- 159}, year = {2011}, abstract = {Vor dem Hintergrund einer sich versch{\"a}rfenden Finanzierungsproblematik im deutschen Gesundheitswesen werden Erkenntnisse der gesundheits{\"o}konomischen Forschung zuk{\"u}nftig weiter an Relevanz gewinnen. Dabei stellt sich die Frage, aus welchen Datenquellen solche Erkenntnisse generiert werden k{\"o}nnen? In den letzten Jahren richtete sich der Fokus insbesondere in der Versorgungsforschung zunehmend auf die Nutzung von Sekund{\"a}rdaten, insbesondere der gesetzlichen Krankenversicherungen. Dabei wird immer wieder auf die grunds{\"a}tzlichen Vorteile solcher Daten hingewiesen: die Abbildung des Versorgungsalltags, die schnelle und kosteng{\"u}nstige Datenverf{\"u}gbarkeit sowie hohe Fallzahlen. Der vorliegende Artikel soll das Potenzial und die Einschr{\"a}nkungen von Sekund{\"a}rdaten zur Beantwortung gesundheits{\"o}konomischer Fragstellungen exemplarisch aufzuzeigen. Im Fokus stehen dabei die Nutzungsm{\"o}glichkeiten routinem{\"a}ßig erhobener Datens{\"a}tze der gesetzlichen Krankenversicherungssysteme (GKV). Dabei erweisen sich Sekund{\"a}rdaten der GKV in der Gesundheits{\"o}konomie als sinnvolle M{\"o}glichkeit zur Durchf{\"u}hrung von Krankheitskostenstudien und Kosten-Minimierungsanalysen sowie als zus{\"a}tzliche Datenbasis f{\"u}r Kosten-Nutzen- bzw. Kosten-Effektivit{\"a}tsanalysen. Die M{\"o}glichkeit zur Durchf{\"u}hrung von Patientenflussanalysen bietet zudem die M{\"o}glichkeit zur Validierung gesundheits{\"o}konomischer Modelle. Als problematisch erweist sich bei der Nutzung von Sekund{\"a}rdaten aber in besonderer Hinsicht die Gefahr des Confounding und der damit verbundenen Fehlinterpretation gesundheits{\"o}konomischer Ergebnisse. Hier muss mit speziellen Maßnahmen (z. B. Datenvalidierung, Plausibilit{\"a}tspr{\"u}fungen, Nutzung von Propensity Scores) eine Kontrolle m{\"o}glicher St{\"o}rgr{\"o}ßen erfolgen. Dennoch sind Krankenkassendaten grunds{\"a}tzlich zur Durchf{\"u}hrung von gesundheits{\"o}konomischen Sekund{\"a}rdatenanalysen geeignet und bieten an dieser Stelle in besonderer Weise unterst{\"u}tzendes Potenzial zur Entscheidungsfindung im Gesundheitswesen.}, language = {de} } @article{HesselJahnDiehmetal.2011, author = {Hessel, Franz and Jahn, Rebecca and Diehm, Curt and Lux, Gerald and Driller, Elke and Ommen, Oliver and Pfaff, Holger and Siebert, Uwe and Pittrow, David and Wasem, J{\"u}rgen and Neumann, Anja}, title = {Effect of Guideline Orientation on the Outcomes of Peripheral Arterial Disease in Primary Care}, series = {Current Medical Research and Opinion}, volume = {27}, journal = {Current Medical Research and Opinion}, number = {6}, pages = {1183 -- 1190}, year = {2011}, abstract = {Peripheral arterial disease (PAD), an established marker of premature death and cardiovascular risk in general, is highly prevalent. We analysed factors associated with poor outcomes in an observational cohort, with particular focus on the effect of guideline orientation in the management of these patients.}, language = {en} } @article{SchermulyDraheimGlasbergetal.2015, author = {Schermuly, Carsten C. and Draheim, Michael and Glasberg, Ronald and Stantchev, Vladimir and Tamm, Gerrit and Hartmann, Michael and Hessel, Franz}, title = {Human resource crises in German hospitals: an explorative study}, series = {Human Resources for Health}, volume = {40}, journal = {Human Resources for Health}, number = {13}, url = {http://nbn-resolving.de/urn:nbn:de:0298-opus4-7288}, pages = {10}, year = {2015}, abstract = {The complexity of providing medical care in a high-tech environment with a highly specialized, limited labour force makes hospitals more crisis-prone than other industries. An effective defence against crises is only possible if the organizational resilience and the capacity to handle crises become part of the hospitals' organizational culture. To become more resilient to crises, a raised awareness — especially in the area of human resource (HR) — is necessary. The aim of this paper is to contribute to the process robustness against crises through the identification and evaluation of relevant HR crises and their causations in hospitals. Qualitative and quantitative methods were combined to identify and evaluate crises in hospitals in the HR sector. A structured workshop with experts was conducted to identify HR crises and their descriptions, as well as causes and consequences for patients and hospitals. To evaluate the findings, an online survey was carried out to rate the occurrence (past, future) and dangerousness of each crisis. Six HR crises were identified in this study: staff shortages, acute loss of personnel following a pandemic, damage to reputation, insufficient communication during restructuring, bullying, and misuse of drugs. The highest occurrence probability in the future was seen in staff shortages, followed by acute loss of personnel following a pandemic. Staff shortages, damage to reputation, and acute loss of personnel following a pandemic were seen as the most dangerous crises. The study concludes that coping with HR crises in hospitals is existential for hospitals and requires increased awareness. The six HR crises identified occurred regularly in German hospitals in the past, and their occurrence probability for the future was rated as high.}, language = {en} } @article{SchermulyDraheimFlessaetal.2014, author = {Schermuly, Carsten C. and Draheim, Michael and Flessa, Steffen and Glasberg, Ronald and Stantchev, Vladimir and Tamm, Gerrit and Hartmann, Michael and Hessel, Franz}, title = {Management of Crises and Risks in German Hospitals: Factors Influencing Medication Errors}, series = {Value in Health}, volume = {17}, journal = {Value in Health}, number = {7}, pages = {A426}, year = {2014}, abstract = {In German hospitals there is a need for optimized crisis- and risk management. About one third of all hospital-acquired patient damages are due to medication errors. The aim of our interdisciplinary project "Risk Management in Hospitals" is to analyze the behavior of the various key players in the fields of medical care, human resources, supply and IT-systems in the context of various simulated risk scenarios as well as to develop adequate risk management tools. In this abstract, the first Results on medication errors are presented.}, language = {en} } @incollection{Hessel2016, author = {Hessel, Franz}, title = {Im Spannungsfeld zwischen Gesundheitsf{\"o}rderung und Ressourcenknappheit}, series = {Trends im Betrieblichen Gesundheitsmanagement}, booktitle = {Trends im Betrieblichen Gesundheitsmanagement}, publisher = {Springer}, address = {Wiesbaden}, publisher = {SRH Berlin University of Applied Sciences}, pages = {43 -- 57}, year = {2016}, abstract = {{\"O}konomische Faktoren spielen bei der Ausgestaltung des Betrieblichen Gesundheitsmanagements eine wichtige Rolle. Zahlreiche und regelm{\"a}ßige Statistiken zu Absentismus und Pr{\"a}sentismus durch berufsbedingte Erkrankungen weisen auf die Notwendigkeit eines Betrieblichen Gesundheitsmanagements f{\"u}r Unternehmen hin. Doch die Auswirkungen gehen {\"u}ber die Konsequenzen f{\"u}r die Unternehmen weit hinaus. Diese Nutzen- und Kostenkonsequenzen eines Betrieblichen Gesundheitsmanagements f{\"u}r die betroffenen Patienten, die Gesellschaft und die Krankenkassen werden in gesundheits{\"o}konomischen Analysen dargestellt. Trotz des hohen gesellschaftlichen Potenzials eines Betrieblichen Gesundheitsmanagements und der grunds{\"a}tzlichen Eignung der methodischen Ans{\"a}tze der Gesundheits{\"o}konomie auch zur Untersuchung dieser Maßnahmen finden sich nur wenige Studien zur medizinischen Wirksamkeit und so gut wie keine gesundheits{\"o}konomischen Evaluationen zu unternehmensbasierten Pr{\"a}ventionskonzepten. Dieser Beitrag fasst die wesentlichen geeigneten methodischen Konzepte der Gesundheits{\"o}konomie sowie den Stand der Literatur zu gesundheits{\"o}konomischen Studien von Maßnahmen des Betrieblichen Gesundheitsmanagements zusammen.}, language = {de} } @incollection{BueschHesselStaehleretal.2016, author = {B{\"u}sch, Victoria and Hessel, Franz and St{\"a}hler, Tobias and Tern{\`e}s, Anabel}, title = {Arbeitsf{\"a}higkeit von Mitarbeitern st{\"a}rken - Good-Practice-Beispiele}, series = {Trends im Betrieblichen Gesundheitsmanagement}, volume = {2016}, booktitle = {Trends im Betrieblichen Gesundheitsmanagement}, publisher = {Springer}, address = {Berlin}, publisher = {SRH Berlin University of Applied Sciences}, pages = {225 -- 236}, year = {2016}, abstract = {Obwohl die Diskussion zur Arbeitsf{\"a}higkeit der Belegschaft bereits durch Trends wie den demografischen Wandel angeregt wurde, sind entsprechende unternehmerische oder politische Umsetzungen noch selten. Um ein ganzheitliches Betriebliches Gesundheitsmanagement umzusetzen, fehlt es h{\"a}ufig an praxistauglichen Modellen und Anregungen. Dieses Kapitel stellt zun{\"a}chst Ilmarinens Work-Ability-Modell bzw. das empirische Werkzeug des Work-Ability-Index als m{\"o}gliche Ansatzpunkte f{\"u}r ein Betriebliches Gesundheitsmanagement vor und zeigt weiterhin Praxisbeispiele auf, die sich mit den Dimensionen bzw. Zielbereichen des Modells assoziieren lassen.}, language = {de} } @incollection{BritzeBueschHesseletal.2016, author = {Britze, Nils and B{\"u}sch, Victoria and Hessel, Franz and St{\"a}hler, Tobias and Tern{\`e}s, Anabel}, title = {Die steigende Bedeutung des betrieblichen Demografie- und Gesundheitsmanagements im 21. Jahrhundert}, series = {Herausforderung Management}, volume = {2016}, booktitle = {Herausforderung Management}, publisher = {SRH Hochschule Heidelberg}, address = {Heidelberg}, publisher = {SRH Berlin University of Applied Sciences}, pages = {62 -- 79}, year = {2016}, abstract = {Keine Angabe No details}, language = {de} }