Comparative sensitivity evaluation for 122 CE-marked rapid diagnostic tests for SARS-CoV-2 antigen, Germany, September 2020 to April 2021

Introduction Numerous CE-marked SARS-CoV-2 antigen rapid diagnostic tests (Ag RDT) are offered in Europe, several of them with unconfirmed quality claims. Aim We performed an independent head-to-head evaluation of the sensitivity of SARS-CoV-2 Ag RDT offered in Germany. Methods We addressed the sensitivity of 122 Ag RDT in direct comparison using a common evaluation panel comprised of 50 specimens. Minimum sensitivity of 75% for panel specimens with a PCR quantification cycle (Cq) ≤ 25 was used to identify Ag RDT eligible for reimbursement in the German healthcare system. Results The sensitivity of different SARS-CoV-2 Ag RDT varied over a wide range. The sensitivity limit of 75% for panel members with Cq ≤ 25 was met by 96 of the 122 tests evaluated; 26 tests exhibited lower sensitivity, few of which failed completely. Some RDT exhibited high sensitivity, e.g. 97.5 % for Cq < 30. Conclusions This comparative evaluation succeeded in distinguishing less sensitive from better performing Ag RDT. Most of the evaluated Ag RDT appeared to be suitable for fast identification of acute infections associated with high viral loads. Market access of SARS-CoV-2 Ag RDT should be based on minimal requirements for sensitivity and specificity.

Integration of complementary and integrative medicine competencies in general practice postgraduate education – development of a novel competency catalogue in Germany

Background Complementary and integrative medical procedures (CIM) play an important role in general practice (GP). Consequently, in some countries (e.g. USA, Australia) specific curricula for the integration of CIM competencies in GP postgraduate education exist. Although Germany is one of the countries where CIM is strongly integrated in general practice, no such catalogue exists up to date. The aim of this study was to define a set of CIM competencies that are seen as relevant and feasible for postgraduate education in the German general practice setting. Methods We used a multi-step, peer-based approach combining four different steps. Firstly, a survey among GP trainees (n = 138) was performed in order to assess needs and attitudes towards CIM. Then, existing competency-based CIM curricula were identified in international literature, translated into German and compared with the needs assessment from the survey. In a next step, we performed a survey among the CIM working group of the German Society for General Medicine and Family Medicine (DEGAM). As a last step, in a peer-based survey, GP trainers, GP trainees, and members of professional CIM associations (n = 131) evaluated a list of CIM competencies according to relevance and feasibility for general practice. Results Within this multistage process, a final catalogue of 16 competencies was defined, covering the following areas: Medical knowledge, patient care and communication, practice-based learning, professionalism, and competencies based on the German healthcare system. Conclusion The final catalogue of CIM competencies is intended to serve for GP training complementing the German competency-based curriculum for general practice. These competencies cover basic skills and are not intended to replace existing additional qualifications awarded by the medical associations in specific CIM methods, such as acupuncture or manual medicine. Therefore, a list of relevant competencies on CIM is available in order to serve as add-on for postgraduate education in general practice in Germany.

Healthcare for Trans*gender People in Germany: Gaps, Challenges, and Perspectives

People whose gender does not correspond to the binary gender system, i.e., trans∗gender people, face two main problems when it comes to healthcare in Germany: (1) They often suffer from general psychiatric comorbidities as well as specific and significant mental distress due to gender dysphoria, and (2) the German healthcare system lacks sufficiently educated and clinically experienced medical personnel who are able to provide specialized healthcare. Aside from transition, it often is extremely difficult for trans∗gender people to get access to and be integrated into the medical system. Stigmatization and pathologization in treatment are widespread, as are long waiting times for specialized healthcare providers who are often only accessible to those trans∗gender people willing to travel long distances. Frequently, trans∗gender people face further difficulties and barriers after transition, as some healthcare professionals fail to provide suitable care (e.g., gynecological consultation for transmen). The ICD-11 German Modification (ICD-11-GM), which should be routinely used by 2022, implements a depathologization of trans∗gender people in the medical system. This paper compares the issues related to health and healthcare of trans∗gender people in Germany with those in other European countries. We review the care offered by specialized centers with regard to treatment of and support for trans∗gender people. We conclude with specific proposals that may contribute to establish an improved, up-to-date, gender-sensitive healthcare system.

Germany

This chapter provides an extended look at health politics and the compulsory health insurance system in Germany. It traces the historical development of the German healthcare system, characterized by its stability through a series of major regime shifts, including National Socialism, the post-World War II return to democracy, and the re-unification of Germany. Corporatist self-regulation has been a defining characteristic of the German system, but since 1989 elements of market and state-led governance have been enhanced, such as with the introduction of free choice of health insurance fund and elements of market competition among the funds, the pooling of insurance contributions into a central fund, and the introduction of substantial risk-sharing instruments. Despite the polarized left–right debate about introducing a universal citizens’ insurance versus a premium-based system, “grand coalition” politics have prevailed, with the broad contours of the German healthcare system being generally accepted and political competition focused on improving the already high quality of healthcare services.

What do patients expect? Assessing patient-centredness from the patients’ perspective: an interview study

ObjectiveAlthough there has been much conceptual work on patient-centredness (PC), patients‘ perspectives on PC were neglected. In a previous study, participating patients rated the relevance of 16 dimensions of an integrative model of PC as high to very high. However, it remained unclear which specific behaviours described in the dimensions were considered most relevant. Thus, the aim of the current study was to further explore which of the specific behaviours described in the model are especially relevant for the high ratings in the previous study.Methods and designWe conducted semistructured interviews with 20 patients with chronic diseases (16 females, 4 males, mean age: 52 years). Patients answered questions regarding their experiences in the German healthcare system and how optimal healthcare would look like from their perspective. Furthermore, patients were asked to reflect on the most important aspects which they had mentioned in the interview before. Data were analysed via content analysis.ResultsParticipants addressed many different aspects of PC, but mostly focused on three major themes: (1) time appropriate access to care, (2) competence, empathy and being taken seriously by HCPs, (3) HCPs’ individual consideration of each patient’s situation (eg, wishes and needs). Minor themes were: (1) taking a holistic perspective of the patient, (2) patient-centred communication, (3) integration of multidisciplinary treatment elements, (4) transparency regarding waiting time and (5) reduction of unequal access to care.ConclusionThis study enriches the construct of PC by depicting essential aspects of PC from the patients’ perspective. The results allow prioritising strategies to implement patient-centred care. Thus, this study helps to pursue the ultimate goal of fostering patient-centred healthcare delivery in Germany.

Desiderata for a Synthetic Clinical Data Generator

The current movement in Medical Informatics towards comprehensive Electronic Health Records (EHRs) has enabled a wide range of secondary use cases for this data. However, due to a number of well-justified concerns and barriers, especially with regards to information privacy, access to real medical records by researchers is often not possible, and indeed not always required. An appealing alternative to the use of real patient data is the employment of a generator for realistic, yet synthetic, EHRs. However, we have identified a number of shortcomings in prior works, especially with regards to the adaptability of the projects to the requirements of the German healthcare system. Based on three case studies, we define a non-exhaustive list of requirements for an ideal generator project that can be used in a wide range of localities and settings, to address and enable future work in this regard.

Knee Surgery during the COVID-19 Lockdown—Experiences of a Level-One Trauma Center in Germany

Background. Almost every sector in the health care is affected by the COVID-19 pandemic. Many studies already investigated the effect on different aspects in orthopedic and trauma care. However, the current literature lacks data regarding the consequence on daily surgical business. Thus, the aim of the present study was to analyze the development of knee-related pathologies and surgical procedures in a German university level-one trauma center during the lockdown phase and early lockdown phase to investigate the impact of the COVID-19 lockdown on orthopedic and trauma knee surgery. Material and Methods. The amount of knee joint surgeries performed during the high-peak COVID-19 crisis in the period of January to May 2020 was evaluated retrospectively and compared to the corresponding time periods of the previous years (2017-2019). Results. The COVID-19 lockdown led to a significant decrease in the number of knee injuries in March and April 2020 by 83.3%. Surgical procedures were reduced by 84.8% during the same period. In May 2020, the number of knee joint procedures returned to an almost prepandemic level. The distribution of urgent and elective knee surgery changed to predominantly acute trauma care at the beginning of the COVID-19 lockdown and persisted through to May 2020. Conclusion. The COVID-19 pandemic had a high impact on emergency and elective knee surgery in a level-one trauma center in Germany during the lockdown phase. It also showed that a level-one trauma center in the German healthcare system is able to handle urgent trauma and orthopedic operations during a worldwide medical crisis and to return to a prepandemic level within a short phase.