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Definition of the Problem: Compassionate use is the use of unapproved drugs in groups of patients suffering from a disease that, in the absence of an alternative treatment option, is life-threatening or leads to severe disability. Physicians are not in charge because access to the drug is only granted by pharmaceutical companies, which comes along with many ethical issues. Launched in 2020, the program of Onasemnogenum abeparvovecum against spinal muscular atrophy in children reached a new dimension. The intent of this drug is to stop the progression of the disease with just a single dose, but the company limited the doses in the program to only 100. The global allocation was by lottery, which was considered a novelty in compassionate use history and therefore widely criticized. This paper investigates alternative allocation principles., Arguments: Each possible principle is accompanied by many aspects that need to be considered with regard to urgency and global distribution. This makes some principles like first-come-first-served seem negligible. Remaining principles are ordered hierarchically to derive an algorithm that can represent an alternative to a lottery. A combination of willingness to participate in research, urgency, and likelihood of success (relative to the availability of supportive treatment options) may be considered in similar cases in future global compassionate use programs with children., Conclusion: Since universal algorithms are difficult to define, allocation criteria should always be discussed by an independent panel of experts. Both the constitution of such a panel and its mandatory consultation are necessary in order to decrease the burden for all those involved and to prevent arbitrariness., (© The Author(s) 2022.)

Background: Numerous diagnostic and therapeutic innovations in the treatment of advanced prostate cancer, both in the hormone-sensitive and in the castration-resistant situation, recently led to a new orientation in the management of this tumor. However, there are potential indications beyond the ones covered by the S3 guideline on early detection, diagnosis and therapy of prostate cancer in clinical care that might be helpful for patients., Objectives: Since July 2018, an interdisciplinary group of experts from nuclear medicine, radiologists, radio-oncologists and urologists developed a consensus paper on state-of-the-art innovations in imaging diagnostics and radionuclide-based therapies for advanced prostate cancer., Conclusions: Provided by the working group are suggestions and strategies to improve the implementation of new imaging techniques such as multiparametric magnetic resonance imaging (mpMRI), PSMA-PET/CT (prostate-specific membrane antigen-positron emission tomography/computed tomography) and innovative therapeutic options (radium-223 dichloride, lutetium-177-PSMA) in the complex treatment of metastatic castration-resistant prostate cancer (mCRPC)., (© 2021. The Author(s).)

Background: Aseptic loosening is one of the most common reasons for revision in knee arthroplasty. Its pathogenesis is multifactorial, and early diagnosis is necessary to initiate appropriate therapy and to avoid serious complications, such as substantial bone loss or even periprosthetic fractures., Objectives: This paper describes the current standard in the diagnosis of aseptic loosening in total knee arthroplasty. Sensitivity and specificity of the individual diagnostic procedures are presented, and other causes for differential diagnoses of painful total knee arthroplasty (TKA) are discussed., Results: In the case of suspected loosening in TKA, infection diagnostics should be performed to rule out periprosthetic infection, as this is crucial in terms of surgical strategy. The gold standard in diagnosing aseptic loosening is conventional radiography. Radiolucent lines at the cement-bone or metal-cement interface of more than 2 mm or increasing in translucency, migration of components, and cement fractures are obvious signs of loosening. Artifact-reduced computed tomography can bring additional information regarding periprosthetic osteolysis. A single bone scan is not reliable in diagnosing aseptic loosening, especially in the first 2 years after surgery. Single photon emission computed tomography (SPECT-CT) could be a useful extension in loosening diagnosis in the future., Conclusions: The diagnosis of aseptic loosening poses a great challenge to the treating physician and requires a structured diagnostic algorithm. After exclusion of infection, conventional radiography is the basic examination, which should be supplemented by computed tomography and nuclear medicine examinations according to the clinical symptoms and the time course., (© 2021. Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Background: Obtaining informed consent is a challenging task and is part of the educational objectives in the German NKLM. Teaching formats are inconsistent and time-consuming, with little emphasis on legal aspects, although they have moved into the focus of attention since the implementation of patient rights laws and play an important role in legal proceedings., Objectives: The aim of this study was the evaluation of medical students' knowledge about the legal aspects of obtaining informed consent. A legal analysis was performed, and the patient rights laws were reviewed with reference to implications for undergraduate medical education., Materials and Methods: After the analysis of laws and jurisdiction, multiple-choice questions regarding the legal aspects of obtaining informed consent were created and placed in the Progress Test Medicine (PTM). A statistical analysis of the results of Berlin medical students was performed descriptively., Results: The answers of 2625 (winter semester 2018/19) and 2409 (summer semester 2019) medical students in Berlin were analyzed. The rate of students who answered the questions about the procedures requiring informed consent and adequate time for consideration increased over time but did not reach comparable values to all PTM questions. Questions about required content were answered correctly by 30 to 60% of the students, regardless of their level of training; we did not see an increase along with the time of study., Conclusion: In our study, we were able to show that medical students of all educational levels show tentativeness when it comes to the legal aspects of obtaining informed consent. Yet, the legal framework offers room for new teaching formats like "Co-Action", introduced in this paper for the first time, where students acquire informed consent while being supervised by the medical doctor in charge., (© 2021. The Author(s).)

Employee health and ability to perform is essential to a functioning health care system. Even before the coronavirus disease 2019 (COVID-19) pandemic, a substantial proportion of employees reported impaired mental health at work. This paper outlines the state of knowledge and evidence on interventions to promote mental health in the workplace, with particular focus on the organization of work and activities. In addition to an initial review of approaches, the factors facilitating successful and effective approaches are addressed., (© 2021. Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Background: In current hospital-based urological care, economic pressure and its influence on urological working and further training conditions are a main point of criticism among young urologists. Against the background of a growing need for young talent in our specialist discipline, there is an urgent need for action. With the introduction of the lower limits for nursing staff, there is now a threat of a reduction in the number of physicians with the aim of reducing costs for business reasons., Objective: A mandatory staffing ratio is often mentioned to counteract the downsizing in German clinics. The role of the lower staffing limit is explained in the following article., Materials and Methods: We have analyzed the current draft laws of the federal government, as well as position papers and statements from federal political representatives such as the Marburger Bund, Bundesverband Deutscher Urologen and the German Medical Association (Bundesärztekammer) since 2018., Results and Conclusion: The analysis of current developments in nursing policy shows that the first step is a needs-based assessment of personnel and subsequent financing in the clinic setting. With adequate staffing, as in the traffic light scheme of the German Medical Association, not only would clinics position themselves as attractive employers and training centers for large parts of the urological medical profession, but would also significantly improve working conditions, patient care and patient safety. Medical training must remain an essential part of everyday hospital life., (© 2021. Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Castleman disease (CD) is a very rare disorder characterised by hyperplasia of the lymphoid tissue. The aetiology varies considerably and includes autoimmunological, infectious, autoinflammatory and paraneoplastic diseases (e.g. MGUS with POEMS syndrome). What they all have in common is usually a dysregulation/overproduction of certain cytokines and growth factors (including interleukin 6 and VEGF). The sum of these changes sometimes causes very heterogeneous symptoms and thus often makes early diagnosis difficult. The prognosis of unrecognised and untreated disease is very serious and has an average 5‑year survival rate of 55-77%. The present paper describes the case of a 79-year-old patient with refractory polyserositis who was correctly diagnosed after > 8 years.

Background: Endometriosis is one of the most common diseases in women of reproductive age. Despite characteristic symptoms such as dysmenorrhea, chronic abdominal pain, dysuria, dyschezia and dyspareunia, the average latency until diagnosis is around 10 years. In addition to the individual limitations, the disease also has economic and health policy relevance. The complaints are followed by reductions in working hours, cyclically recurring short-term sick leave or presenteeism with reduced performance., Objective: An overview of the main recommendations of the S2k guideline on the diagnosis and treatment of endometriosis., Material and Methods: For the S2k guideline "Diagnostics and therapy of endometriosis", a systematic literature search was conducted in PubMed and Cochrane according to a defined algorithm and over a period of more than 5 years, from 01.01.2014 to 31.12.2018. For the evaluation, 322 publications, including systematic reviews, meta-analyses and randomized controlled trials were considered and these were assessed by 41 mandate holders and representatives from 25 Association of the Scientific Medical Societies in Germany (AWMF) and non-AWMF professional societies, organizations, associations and working groups of the German Society for Gynecology and Obstetrics (DGGG), as well as two patient target groups., Results: In a structured consensus process, 48 recommendations and 27 statements were formulated, which are presented in extracts in this paper., Discussion: Interdisciplinary cooperation is essential in the treatment of patients with (suspected) endometriosis. This team should include all necessary disciplines in a cross-sectoral network. This is most likely to be achieved in a certified structure.

The development of the WHO classification of tumors of the breast is driven by new knowledge from research whose translation into daily practice is considered clinically relevant. The fifth edition represents an update of the fourth edition and essentially follows the previously known systematics. The histologic features of the lesions continue to form the basis of the classification in the update. This also applies to the definition of invasive tumor types. However, several new molecular classifications as well as additional prognostic and predictive factors are presented and discussed, which improve prognosis estimation and therapy decisions. This paper aims to present the main changes in the current WHO classification. These include the revised definition of mixed invasive carcinomas, the introduction of new special invasive entities (tall cell carcinoma with reversed polarity, mucinous cystadenocarcinoma), the deletion of special invasive types and their classification as variants of invasive carcinoma, NST (no special type, including medullary, lipid-rich, glycogen-rich, among others), the typing of primary neuroendocrine neoplasms of the breast by analogy with other organ systems, changes in the dignity criteria of phyllodes tumors, and the revised subtyping of lobular carcinoma in situ (LCIS). In addition to improvements in the fifth edition of the classification, flaws are also highlighted. A section is devoted to new molecular parameters.