Testicular cancer follow-up costs in Germany from 2000 to 2015.

PURPOSE: Advances in testicular cancer screening and therapy increased 10-year survival to 97% despite a rising incidence; eventually expanding the population of survivors requiring follow-up. We analyzed 10-year follow-up costs after testicular cancer treatment in Germany during 2000, 2008, and 2015. METHODS: Testicular cancer follow-up guidelines were extracted from the European Association of Urology. Per patient costs were estimated with a micro-costing approach considering direct and indirect medical expenses derived from expert interviews, literature research, and official scales of tariffs. Three perspectives covering costs for patients, providers, and insurers were included to estimate societal costs. Cost progression was compared across cancer histology, stage, stakeholders, resource use, and follow-up years. RESULTS: Mean 10-year follow-up costs per patient for stage I seminomatous germ-cell tumors (SGCT) on surveillance declined from EUR 11,995 in 2000 to EUR 4,430 in 2015 (p < 0.001). Advanced SGCT spending shrank from EUR 13,866 to EUR 9,724 (p < 0.001). In contrast, expenditure for stage II SGCT increased from EUR 7,159 to EUR 9,724 (p < 0.001). While insurers covered 32% of costs in 2000, only 13% of costs were reimbursed in 2015 (p < 0.001). 70% of SGCT follow-up resources were consumed by medical imaging (x-ray, CT, ultrasound, FDG-PET). Spending was unevenly distributed across follow-up years (years 1-2: 50%, years 3-5: 39%, years 5-10: 11%). CONCLUSIONS: The increasing prevalence of testicular cancer survivors caused German statutory insurers to cut per patient cost by up to 80% by budgeting services and decreasing reimbursement rates. The economic burden was gradually redistributed to patients and providers.

An ethical analysis of exception from informed consent regulations.

Federal regulations enacted in 1996 allow clinical research with an exception from informed consent in select emergency circumstances. Such research is only permitted when the therapy may directly benefit the research participant and it is not possible to conduct the research with informed consent. Among others, protective mechanisms include a process of community consultation and public disclosure and the establishment of a mandatory data safety monitoring board. Although the regulations do not preserve the right of self-determination of the research participant, the author argues that they do provide an ethical means to advance the science of resuscitation.

Good clinical practice: historical background and key aspects.

Clinical research trials (both academic and industry sponsored) are increasingly playing a role in various medical disciplines, including younger fields of clinical trial interest, such as nuclear medicine research. Knowledge for and compliance with good clinical practice (GCP) is essential for anyone involved. In this review article, key aspects of GCP and the responsibilities of investigators, monitors and sponsors are described. In addition, a comprehensive overview of the historical background on the development of GCP from the US Pure Food and Drugs Act of 1906 over the Nuremberg Code, the Kefauver-Harris Amendments and the Declaration of Helsinki until now is given. Knowledge of the historical background may help understand the developments in GCP.

A study of the readiness of Jewish/Israeli students in the health professions to authorize and execute involuntary mass euthanasia of "severely handicapped" patients.

The responses of 92 Jewish/Israeli students in the health professions in Israel were studied in the context of a projected future situation where the subjects would be working as physicians/psychologists/social workers, first in a developing country somewhere in Africa, and then, in the second experimental scenario, at a well-known treatment institution in the center of Israel. A successive series of contraints were described that led to a scarcity of resources, in which context the health authorities considered it advisable first to limit and then to curtail the treatment of the severebly handicapped who could benefit least from treatment, and as the situation became more severe to implement a program of involuntary mass euthanasia. Although an eithical point of view would call for zero participation in the policies which would bring about dealths of patients, it had been predicted that as many as 15% of the subjects would agree to curtailing treatment, 5% to participate in planning involunary mass euthanasia, and 2% to execute the euthanasia themselves. However, the results were that in African 39% agreed to curtail treatment, 17% to plan euthanasia, and 11% them selves to terminate the patients' lives; in Israel the corresponding figures were 38%, 12%, and 9% - the differences between Africa and Israel were not significant. The study is seen as contributing to emerging knowledge (in the Milgram tradition) of the widespread availability of human beings to undertake policies which harm, hurt and kill other human beings when instructed to do so by a policy directive.