@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{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} }