Research
Professor Dr. Dr. Klaus Nagels and his team perform interdisciplinary research in the areas of medical management and health services research. Particular priority of our research is represented by the connection between research-based insights and their practice relevance for health care delivery. It is part of our research “DNA” that theory and practice are not a contradictory. Therefore, our cooperation partners from the health industry, health business or health policy appreciate our input to solve their most often pressing issues. Accordingly, our research is on innovation issues and most often closely related to translation of innovations to the day-to-day health care delivery practice. In order to assess and appraise the potential of innovations, we deploy health economic, clinical and epidemiological methodologies as well as assessment tools commonly deployed in economics and business administration disciplines to answer the related research questions.
Health systems all over the world are faced with a continuous stream of innovations from a variety of generating sources. These include a range of established enterprises with industrial or service business models (pharmaceuticals, medical devices, information/digital technologies) as well as start-ups with strong ties to universities and other research institutions. Innovation intensity exerts enormous pressure on health care systems, which need to adapt with much more flexibly than in the past. The convergence of innovations from different fields increases the complexity and the transformation pressure on national and international health care ecosystems. Therefore, resource allocation and funding decisions are more demanding than ever. Given that, evidence and evidence generation are crucial. In this process, our role is to support the health economic transparency by raising and answering related research questions.
The medical topics of current research projects are represented by neurology, cardiology and oncology. Furthermore, vector-borne viral infections, which are regarded as a subject of tropical medicine, are part of our research interest. Since 2012, we have been cooperating with the Friedrich-Baur Institute of the Ludwig-Maximillian-University (LMU) in Munich in neuromuscular diseases, spinal muscular atrophy (SMA), Duchenne muscular dystrophy, Charcot-Marie-Tooth (CMT) and inclusion body myositis (IBM). For some patients, e. g., those diagnosed with SMA, therapies have been developed and implemented for the first time that have become an effective and common care constituent. Cell and gene therapies have received marketing authorization in some countries and will continue to emerge for treatment of neuromuscular disease. However, affected patients still suffer from an unmet medical need. Therefore, we strive not only to assess the medical and economic impact for the patients, but also to better understand the effects on the environment of severely ill patients. Besides, we assess the care process itself and its implications for informal caregivers.
Since 2019, we also added mental diseases to our research portfolio especially the wide field of depression. Moreover, the focus is on diseases characterized or accompanied by cognitive impairment and progressive neurological deterioration, such as dementia with various causes and symptoms. In this medical context, we develop and assess treatment and care solutions based on digital technologies, in particular virtual reality components.
Another research field we focus on is proton beam therapy (PBT), a sub-modality used to treat cancer patients. Its medical use was already discussed in 1946. Proton beam therapy is a particle-based approach in contrast to photon-based and linear accelerator generated radiotherapy representing the usual care. The general advantage of the technology is that it has the potential to spare healthy tissue the exposure of toxic radiation, whereas it also allows to escalate the dose to tumor tissues. PBT has shown safe and effective application but is still facing two challenges. Firstly, the production and application of the radiotherapy involves the use of very complex technical equipment, which has partly prototype character and thus is lacking economies of scale. This results in high up-front investments (typically > 150 € millions, meanwhile 30 to 50 € millions) and lead to significantly higher treatment cost compared to usual care. Secondly, the benefits of lower radiation toxicity as set out further above have not been demonstrated in all the cancer types for which PBT could work when applying evidence levels to clinical trial results. Therefore, the documented evidence on superiority of PBT over photons is not available. Correspondingly, cost-effectiveness or comparative effectiveness could not be demonstrated to allow for broader access of patients to PBT. Our research has provided a better insight of worldwide PBT diffusion in cancer treatment since 1987 and has compared the diffusion pattern with the photons generated by linear accelerators. Since 2015, Professor Nagels has contributed to the European Particle Therapy Network (EPTN), which recently became an official initiative of the ESTRO (European Society for Radiotherapy and Oncology).
- Neuromuscular DiseasesHide
-
Project Research Context - Objective - Status Contact Person Muscular dystrophy Duchenne and Becker The rare neuromuscular disease is characterized by a typical course of disease in clinical definable stages. The disease is not curable and so far only limited treatable. The research objective is to assess the quality of life (QoL) of those affected while involving family caregivers. Costs of treatment and illness as well as financial burdens for parents are recorded systematically. Corresponding parameters of the milder Becker's muscular dystrophy, which has a much better prognosis, serve as a comparison, since the associated health status could be achieved through innovative therapeutic approaches if necessary.
Cooperation Partner: Friedrich-Baur-Institut, University Hospital of the LMU Munich
Status: Largely completed projectConstanze Klug Spinal muscular atrophy (SMA) This Neuromuscular disease occurs in various forms, some of which are characterized by fatal variants. In the meantime with Nusinersen (antisense oligonucleotide) there is now an effective drug therapy with considerable additional benefits for patients available. The research objective is also to record the QoL for the non-fatal course forms including the health economic modelling in the foreground of the research project.
Cooperation Partner: Friedrich-Baur-Institut, University Hospital of the LMU Munich (Prof. Dr. Maggie Walter)
Status: Largely completed projectConstanze Klug Charcot-Marie-Tooth Diseases (CMT) This project focuses on Charcot-Marie-Tooth diseases, also known as hereditary motor sensory neuropathies (HMSN). CMT diseases show slowly progressive degenerations of the peripheral, especially motor nerves . As a result the control of muscularly mediated movement increasingly gets lost. The clinical pictures are characterized by a high variability. We try to better understand treatment costs of the symptoms associated with the disease and how the symptoms are classified by patients with regard to their severity. Quality of life measurements are in the foreground (so-called patient-reported outcome (PRO)).
Cooperation Partner: Friedrich-Baur-Institut, University Hospital of the LMU Munich (Prof. Dr. Maggie Walter), Max Planck Institute for Experimental Medicine Göttingen (Prof. Dr. Michael Sereda), CMT-Net Göttingen
Status: Largely completed project
Elisabeth Schorling, Laura Gumbert Inclusion body myositis (Inclusion Body Myositis (IBM)) Inclusion body myositis is an incurable inflammatory muscle disease characterized by slowly progressive muscle weakness. The disease causes an increasing loss of walking ability, a loss of strength in arms and hands and can also cause swallowing disorders. The research objective is to systematically record the costs of treatment and illness of these comparatively frequent muscle diseases. The planned investigations will be supplemented by measurements of quality of life. As with the neuromuscular diseases already mentioned above, specific disease phenomena will be included in health economic modelling.
Cooperation Partner: Friedrich-Baur-Institute, University Hospital of the LMU Munich (Prof. Dr. Maggie Walter)
Status: Completed project
Klaus Nagels,
Katja SennMedical influence of severe chronic diseases on caring relatives Many serious illnesses with chronic course mean an enormous burden for the caring relatives. Research is still in its infancy. The burdens of care and nursing, in turn, often lead to illnesses among the caring relatives. In the case of selected diseases, we want to better understand how the medical and health economic effects of the burdens are to be assessed, in line with the research objective of this project.
Cooperation Partner: Friedrich-Baur-Institute, University Hospital of the LMU Munich (Prof. Dr. Maggie Walter)
Status: Completed project
Laura Gumbert - Radiooncology and OncologyHide
-
Project Research Context - Objective - Status Contact Person Proton irradiation from the perspective of technology and innovation management
Proton irradiation is a complex treatment modality in radiooncology. The investment costs required to operate such a system exceed 100 million euros and thus exceed ten times the volume needed for standard irradiation. Due to a lack of financing and coordination of the necessary clinical development, the clinical advantages have not yet been documented internationally in accordance with today's requirements. With the exception of the treatment of i.a. melanomas in the eye or skull base tumours, the treatment of other solid tumours such as the prostate has so far only been possible in individual cases. The research objective is to use methods of innovation and technology management to understand whether, in the absence of clinical evidence, microeconomic parameters indicate a growing global diffusion with regard to the treatment of solid tumours. In addition, the research objective is to model how retrospectively other radiooncological technologies (linear accelerators, IMRT modules) have spread.
Status: Completed project
Klaus Nagels Health economic evaluation of proton irradiation In Europe, new proton irradiation centres have been established or are under construction in recent years. The aim of the association of leading scientists from the European proton radiation centres is to place the position of this radiooncological treatment modality in the context of existing radiooncological treatment options. In addition to a clinically oriented working group, there is also a health economic one headed by Professor Lievens and Professor Nagels.
Cooperation partners: European working group on proton therapy (affiliated to ESTRO) Brussels, Ghent University Hospital (Belgium, Prof. Dr. Yolande Lievens), Paul Schcherer Institute Baden (Switzerland, Prof. Dr. Damien Weber), proton radiation centres in Europe (including planned facilities in Manchester and London, among others)
Status: Ongoing project
Klaus Nagels Epidemiological studies on breast cancer, basaliomas and melanomas Studies on epidemiology (incidences, prevalences) of various stages of the listed cancers. The aim was to collect precise epidemiological parameters for certain disease states and stages.
Cooperation partners: Top 10 pharmaceutical companies
Status: Completed project
Klaus Nagels - Technology-supported Health CareHide
-
Project Research Context - Objective - Status Contact Person EMIDOC In this research project, the focus is on the identification and evaluation of digitally-enabled care in outpatient health care delivery settings. The main goal is the optimization of traditional processes in medical practices and structures of the ecosystem of outpatient medical care. On the basis of qualitative and quantitative data collection, digitally-enabled opportunities for efficiency increases will be identified and their concrete effects will be illustrated using process models.
Cooperation Partner: medatixx GmbH & Co. KG
Status: Ongoing project
Michael Burkard Virtual Reality in nursing homes The aim of this study was to develop and investigate an enhanced virtual reality (eVR) concept against social isolation and loneliness of residents in nursing homes. It included the active involvement of relatives in terms of individual 360°-videos for the resident. The study evaluated the attitude of residents and employees towards the eVR concept and the technical requirements in the nursing homes.
Status: Completed project
Lena Schinner DiTram
The project focuses on digital transformation in outpatient health care with a focus on efficiency contributions and specific investment behaviour of established health care providers. In this context, the effects of digital applications on the physician-patient relationship will also be investigated on the basis of qualitative and quantitative data collection.
Cooperation Partner: medatixx GmbH & Co. KG
Status: Completed projectMediCO
Within the framework of the project, the research focus is on investigating the potential for technology-supported forms of health care in areas with different health care densities. In addition to already known telemedical applications, options for further digitisation will be worked out in the overall view. Furthermore, a health economic evaluation of the digital transformation potential of corresponding solutions will be developed in this context, which can be used as a standardised procedure for areas with different supply densities.
Cooperation Partner: Oberfrankenstiftung, City of Kulmbach, Karl-Landsteiner-Privatuniversität Krems (Austria)
Status: Completed project
Reiner Hofmann, Dominik Seitz CardioBBEAT The project focused on the clinical and health economic evaluation of a digital telemonitoring solution within the treatment of patients with chronic heart failure. To this date, evidence that non-invasive remote telemonitoring (RTM) for patients with heart failure with reduced ejection fraction (HFrEF) offers clinical benefits or a health economic advantage over usual care has been controversial. Therefore, a prospective study design was applied that met the highest evidence requirements (multicentre RCT with 621 participating patients who showed a high risk of decompensation) to assess the clinical and health economic impact of such a dedicated RTM system within an actual health care setting. A key differentiating feature of the study compared to other scientific work in the German or international health care context was that, in addition to the high-quality study design, real cost data directly obtained from patients health insurance funds were used for the economic evaluation. The project was originally initiated by Prof. Dr. mult. Eckhard Nagel and is registered with ClinTrials.gov under the identifier NCT02293252.
Cooperation Partner: Various cardiological clinics and centres of university hospitals in Germany; Head of Clinical Trial: Prof. Dr. Eckart Fleck (German Heart Center Berlin) and Prof. Dr. Heinz Völler (University of Potsdam); Head of Biostatistics: Prof. Dr. Karl Wegscheider (University Hospital Hamburg-Eppendorf); Funded by the Federal Ministry of Education and Research (BMBF)
Status: Completed projectDominik Bindl, Reiner Hofmann - Vector-borne viral infectionsHide
-
Project Research Context - Objective - Status Conact Person Health economic analysis and modelling of the spread of vector-borne virus infections in Germany and other regions
Vectors are insects, such as certain mosquito species, which can transmit viral infectious diseases. Due to climate change, the propagation patterns of mosquito acting as vectors in viral infections are changing. As a result of climate change and globalisation, various autochthonous transmissions outside of endemic countries have already occurred in the past. Infections with viruses (Chikungunya, Zika, Dengue) have been observed, which typically do not occur in these areas. The aim of the research is to investigate the health economic and clinical effects of these infections using climate and habitat models describing the spread of the vectors. The interdisciplinary research project is based on the research results of the working group of Prof. Dr. Carl Beierkuhnlein.
Cooperation partner: Nationale Forschungsplattform für Zoonosen, Bundesministerium für Umwelt, Naturschutz, Bau und Reaktorsicherheit
Status: Completed ProjectKlaus Nagels, Elisabeth Schorling, Fabienne Englmeier