Radiation therapy: Regulatory framework and constraints.

The purpose of this article is to describe the regulatory framework of the radiotherapy practice in France.

[There is no progress without school. Postgraduate specialization school completes the paradigm shift in palliative care.] / Non c'è progresso senza scuola. La Scuola di specializzazione completa il cambio di paradigma delle cure palliative.

With the conversion of law decree no. 34 of 19 May 2020, bearing urgent measures concerning health, support to work and the economy, as well as social policies related to CoViD-19 epidemiological emergency, thanks to the approval of an amendment to legislative decree "Rilancio" signed by Giorgio Trizzino, the Specialization school in medicine and palliative care will be established starting from a.y. 2021-2022. Additionally, a course in pediatric palliative care will be introduced in pediatrics specialization schools. The news has been welcomed with enthusiasm by the scientific community and the main stakeholders, some of which have made a strong contribution to this result: the Italian Society for Palliative Care, the Italian Federation for Palliative Care, the Maruzza Levebvre d'Ovidio Foundation, as well as the many professionals, institutions, and NPOs that have been supporting for the past forty years the progress of palliative care in Italy. An assessment of the impact of such a measure and its effects entails due process and contextualization in different areas: first of all, that of demand and current supply, followed by the historical-cultural, the social, and the normative.

[Weighting of Orthopaedics & Trauma Surgery in the Medical State Examination - Comparison of the Written Examination with the National Catalogue of Learning Objectives in Surgery]. / Die Wertigkeit des gemeinsamen Faches Orthopädie-Unfallchirurgie im 2. Staatsexamen ­ Vergleich der schriftlichen 2. Staatsexamina mit dem Nationalen Kompetenzbasierten Lernzielkatalog Chirurgie.

BACKGROUND: The national competence-based catalogue of learning-goals in surgery (NKLC) defines competence levels for each of its 230 goals, including "competence level in 1: factual knowledge" up to "competence level 3: independent action". Aside from the cumulative examinations influencing the learning behaviour of students, those teaching targets do not affect the second state examination. This study analyses the extent to which the questions of the German second medical licensing examination compiled by the IMPP (central German institute for medical and pharmaceutical examinations) are congruent with the trauma-surgical and orthopaedic learning goals in the NKLC, in which this thematic focus is emphasised. MATERIAL AND METHODS: Exam questions from autumn 2009 to autumn 2014 (n = 11) were retrospectively analysed. Orthopaedic and trauma-surgical teaching targets defined in NKLC were identified by five senior orthopaedic physicians and trauma surgery experts. All questions addressing one of these learning goals were identified and analysed (re: the number of learning goals, the number of questions addressing a trauma-surgical, or orthopaedic goal, as well as different competency levels). RESULTS: We found 113 learning goals of NKLC (49.1% of the overall NKLC learning goals) identified as orthopaedic or trauma surgery subjects. During the study period, 543 questions included teaching targets referring to orthopaedic or trauma surgery subjects (15.6% of the total of 3480 questions). Per exam, a mean of 49.36 ± 14.1 questions (minimum 30; maximum 80) was identified that addressed a learning goal referring to these issues. For each exam, 13.45 ± 6.39 (minimum 6; maximum 24) questions referred to learning goals of competence level 3a and b, 21.45 ± 9.94 (minimum 9; maximum 39) questions referred to learning goals of competence level 2, and 14.45 ± 6.36 (minimum 6; maximum 25) questions referred to learning goals of competence level 1. Most questions addressed the topic: "disorders of the rheumatic spectrum" (n = 16 questions in autumn 2009). CONCLUSION: Questions focusing on orthopaedic and trauma surgery appeared sufficiently often during the second state examination. There is a thematic imbalance, and important clinical learning goals tagged with high competence levels were not addressed in a satisfactory manner. This indicates that a clear adjustment between the state examination and NKLC is necessary.

[Current SHI physician legislation: succession rules for surgical seats : Surgical vacancies can be filled with orthopedic/trauma surgery specialists only within narrow limits]. / Aktuelles Vertragsarztrecht: Nachfolge bei Chirurgensitzen : Nachbesetzung einer chirurgischen Zulassung durch Fachärzte für Orthopädie/Unfallchirurgie nur in engen Grenzen.

It is a physician's certified continuing medical education category-rather than their actual medical activity, in this case in the field of trauma surgery-that is decisive in filling statutory health insurance (SHI) practice vacancies. This evaluation arising from §16 of the requirement planning guideline applies accordingly when filling physician vacancies. Thus physician vacancies or statutory health insurance (SHI) practice places can only be filled by a physician in the same physician group in line with requirement planning. Scope for argumentation initially remains in the context of filling surgical SHI physician vacancies where the ceding physician is certified as an accident insurance consultant.

[Approval procedures for clinical trials in the field of radiation oncology]. / Genehmigungsverfahren klinischer Studien im Bereich der Radioonkologie.

BACKGROUND AND PURPOSE: Application of ionizing radiation for the purpose of medical research in Germany needs to be approved by the national authority for radiation protection (Bundesamt für Strahlenschutz, BfS). For studies in the field of radiation oncology, differentiation between use of radiation for "medical care (Heilkunde)" versus "medical research" frequently leads to contradictions. The aim of this article is to provide principle investigators, individuals, and institutions involved in the process, as well as institutional review or ethics committees, with the necessary information for this assessment. Information on the legal frame and the approval procedures are also provided. METHODS: A workshop was co-organized by the German Society for Radiation Oncology (DEGRO), the Working Party for Radiation Oncology (ARO) of the German Cancer Society (DKG), the German Society for Medical Physics (DGMP), and the German Cancer Consortium (DKTK) in October 2013. This paper summarizes the results of the workshop and the follow-up discussions between the organizers and the BfS. RESULTS: Differentiating between "Heilkunde" which does not need to be approved by the BfS and "medical research" is whether the specific application of radiation (beam quality, dose, schedule, target volume, etc.) is a clinically established and recognized procedure. This must be answered by the qualified physician(s) ("fachkundiger Arzt" according to German radiation protection law) in charge of the study and the treatments of the patients within the study, taking into consideration of the best available evidence from clinical studies, guidelines and consensus papers. Among the important parameters for assessment are indication, total dose, and fractionation. Radiation treatments applied outside clinical trials do not require approval by the BfS, even if they are applied within a randomized or nonrandomized clinical trial. The decision-making by the "fachkundigem Arzt" may be supported on request by an opinion given by the DEGRO Expert Committee for clinical trials. CONCLUSION: An important aim for promoting clinical research and patient care in radiation oncology is to further professionalize planning and implementation of clinical trials in this field. Correct assessment, at an early stage, whether a trial needs to be approved by the BfS may reduce unnecessary costs and reduce the time needed for the approval procedure for those trials which need to be assessed by the BfS.

[Continuing Medical Education in Germany - mandatory and voluntary obligations]. / Ärztliche Fortbildung in Deutschland -Pflicht und Freiwilligkeit.

After 1945 the common medical training infrastructure was broken up into two different political systems. While in the Federal Republic of Germany the structure was based on physicians' self-governance, in the German Democratic Republic medical professional structures were organised by the government. After the unification of the two German states, which took place on October 3, 1990, the centralistic structure was replaced by the system of physician self-governance. Before January 1, 2004, continuing medical education (CME) in West Germany relied on a system of voluntary obligations. In East Germany, though, professional CMEs were compulsory; they were called "obligatorische periphere Fortbildung." Based on 15 expert interviews on the topic of "CME in Germany", the different circumstances and conditions were analysed taking account of the historical background. Only selected professionals with experience in both German states (one with a federal, the other with a centralistic system), were chosen for the survey.

The requirements of a specialist Breast Centre.

INTRODUCTION: In recognition of the advances and evidence based changes in clinical practice that have occurred in recent years and taking into account the knowledge and experience accumulated through the voluntary breast unit certification programme, Eusoma has produced this up-dated and revised guidelines on the requirements of a Specialist Breast Centre (BC). METHODS: The content of these guidelines is based on evidence from the recent relevant peer reviewed literature and the consensus of a multidisciplinary team of European experts. The guidelines define the requirements for each breast service and for the specialists who work in specialist Breast Centres. RESULTS: The guidelines identify the minimum requirements needed to set up a BC, these being an integrated Breast Centre, dealing with a sufficient number of cases to allow effective working and continuing expertise, dedicated specialists working with a multidisciplinary approach, providing all services throughout the patients pathway and data collection and audit. It is essential that the BC also guarantees the continuity of care for patients with advanced (metastatic) disease offering treatments according to multidisciplinary competencies and a high quality palliative care service. The BC must ensure that comprehensive support and expertise may be needed, not only through the core BC team, but also ensure that all other medical and paramedical expertise that may be necessary depending on the individual case are freely available, referring the patient to the specific care provider depending on the problem. CONCLUSIONS: Applying minimum requirements and quality indicators is essential to improve organisation, performance and outcome in breast care. Efficacy and compliance have to be constantly monitored to evaluate the quality of patient care and to allow appropriate corrective actions leading to improvements in patient care.

Melanoma, version 2.2013: featured updates to the NCCN guidelines.

The NCCN Guidelines for Melanoma provide multidisciplinary recommendations on the clinical management of patients with melanoma. This NCCN Guidelines Insights report highlights notable recent updates. Foremost of these is the exciting addition of the novel agents ipilimumab and vemurafenib for treatment of advanced melanoma. The NCCN panel also included imatinib as a treatment for KIT-mutated tumors and pegylated interferon alfa-2b as an option for adjuvant therapy. Also important are revisions to the initial stratification of early-stage lesions based on the risk of sentinel lymph node metastases, and revised recommendations on the use of sentinel lymph node biopsy for low-risk groups. Finally, the NCCN panel reached clinical consensus on clarifying the role of imaging in the workup of patients with melanoma.

Quality indicators in the management of bladder cancer.

Bladder cancer is predominantly seen in elderly patients. With the aging United States population, the incidence and prevalence of bladder cancer are on the rise, heightening the relevance of this disease as a public health issue. Despite having one of the greatest average cancer treatment costs per patient, improvements in disease-specific survival have been subtle. Clinical guidelines based predominantly on expert opinion and randomized controlled studies offer some guidance, but adherence to these guidelines is lacking. Building awareness of quality indicators to optimize patient care represents an opportunity to improve bladder cancer outcomes. Although quality indicators exist for other disease states, widely accepted quality indicators for the management of bladder cancer have not yet been established. This article proposes an initial set of quality indicators for both non-muscle-invasive and muscle-invasive bladder cancer based on established clinical guidelines and the available literature.