Procedures In Germany Research Articles

Participation and influence of welfare associations in early childhood education in legislative procedures in Germany

ABSTRACT In Germany, responsibility for early childhood education and care (ECEC) lies with the 16 federal states, which define the structures, financing and regulations concerning ECEC. Due to a subsidiary system, municipalities are not able to offer ECEC as long as private providers offer enough places. These providers employ a large variety of pedagogical concepts and practices. The article explores the role of welfare associations and interest groups in ECEC policies. What is their position in legislative procedures and their influence on the development of a competent system under the perspective of professionalization? First, we give a theoretical framework about professionalization and the development of a competent system and then describe the structure of the German ECEC system. Then we provide a content analysis of documents on the influence of associations in an exemplary legislative procedure to promote quality in ECEC. The results illustrate how welfare associations can influence ECEC policies.

Risk and benefits of expanded donor screening: A viewpoint from Germany.

This review describes the risks and benefits of expanding screening for transmissible pathogens in deceased organ donors. The focus is on the experience and procedure in Germany to make a decision on how to proceed with a possible donor. Three issues are of interest in how screening policies impact the process with the aim of mitigating unexpected transmission risks: (1) Should we add universal or targeted nucleic acid testing to serological tests for common blood-borne viruses (BBVs; HIV, HBV, and HCV)? (2) Which tests should be added for screening in a geographically restricted region beyond testing for these BBVs? (3) Being faced with changes (e.g., climate and population) in the own geographically restricted region, what strategies are needed before implementing new tests, and which considerations apply for proper indication to do this? Testing may only be effective when during donor characterization the appropriate conclusions are drawn from the existing findings and screening tests are initiated. This statement overlaps the need to implement universal screening for a pathogen or targeted screening based on the risk that the donor has acquired the transmissible pathogen or is not as possible to identify by current methods of clinical judgment and/or specific tests.

Historical outline of the development of the principle of good faith in civil procedure in Germany and France

The article analyzes the concept of good faith on the example of its development in civil proceedings in Germany and France. The author traces the relationship between the good faith of Roman civil procedure and the good faith of continental European countries, which was developed through the reception of Roman law. he author examines a number of sources of the so-called barbarian law in the context of good faith and its negative manifestation - bad faith in procedural communication and counteraction thereto. The author defines good faith as a condition for proper procedural behavior in the sources of law of the Holy Roman Empire of the Germanic nation and traces the history of the term Treu und Glauben. The author examines the concepts of correlation between the Roman term bona fides and the German term Treu und Glauben, which has become a general principle of various branches of law, including civil procedure law. The author examines the presence of the good faith principle in the modern German Code of Civil Procedure. The author also analyzes the concept of the formation of the principle of good faith in civil proceedings in France, for which purpose the medieval rules of customary law contained in such legal sources as the Coutumes Beauvais are studied. Special attention is paid to an important source of French procedural law of modern times - the Ordinance of Louis XIV of 1667 (Louis Code), which was the basis for the Civil Procedure Code of Napoleon of 1806 and whose provisions contained measures to counteract the abuse of procedural rights, and in some cases the term good faith as a measure of exemplary procedural communication. The author also reviews the provisions of the current French Code of Civil Procedure, which entered into force on January 1, 1976, where the principle of good faith is applied both as a counteraction to unfair procedural behavior and as a standard of procedural behavior which provides for the proper performance of duties and exercise of rights. The author determines that the principle of good faith is primarily found in substantive law, both in Germany and France, from where it is integrated into procedural law.

Updated analysis of the prescription and evaluation of protein kinase inhibitors for oncology in Germany.

A recent analysis from our group ( https://pubmed.ncbi.nlm.nih.gov/37014400/ ) has shown that the immense costs of the 20 protein kinase inhibitors for oncology approved from 2015 to 2019 are largely caused by drugs whose additional benefit has not been proven. We updated our analysis by adding the newly approved protein kinase inhibitors of the years 2020 and 2021. Based on the 2021 and 2022 Arzneiverordnungsreport (AVR), we expanded our analysis to include a total of nine protein kinase inhibitors newly approved by the European Medicines Agency (EMA) in 2020 and 2021. As a result, 29 protein kinase inhibitors were identified for an update of our analysis. For these 29 drugs, all additional benefit assessments published by the Gemeinsamer Bundesausschuss (GBA) were analyzed. The additional benefit assessments of the GBA were compared with the corresponding assessments of the European Society for Medical Oncology (ESMO), the Deutsche Gesellschaft für Hämatologie und Onkologie (DGHO, German Society for Hematology and Oncology) and the Arzneimittelkommission der deutschen Ärzteschaft (AkdÄ, Drug Commission of the German Medical Association). In addition, a total number of 91 drug advertisements published in the journal Oncology Research and Treatment in 2022 were analyzed. The number of protein kinase inhibitors for which no additional benefit can be found by the GBA is increasing, whereas the number of drugs for which a considerable additional benefit can be found is decreasing. Thus, in the current 2022 (re)assessment of additional benefit by the GBA, no additional benefit was identified for 50% of the drugs (2020, 46%). Nineteen percent were assessed with a minor additional benefit (2020, 18%) and also 19% with a considerable additional benefit (2020, 27%). For 12% of the drugs, the additional benefit could not be quantified by the GBA (2020, 9%). The benefit assessments by other medical societies often differ significantly from those of the GBA, mainly due to different evaluations of various endpoint parameters. In addition, more and more protein kinase inhibitors are being approved as orphan drugs. However, their additional benefit cannot be quantified by the GBA in most cases (78%). In 38% of the advertisements of an oncology journal, protein kinase inhibitors are promoted, which shows the pharmacoeconomic importance of these drugs. In summary, the current additional benefit assessment procedure in Germany is very questionable, and reforms are urgently needed to maintain the stability of the German healthcare system, which is being undermined by the high cost of medicines, particularly for drugs whose additional benefits have not been proven.

German Heart Surgery Report 2023: The Annual Updated Registry of the German Society for Thoracic and Cardiovascular Surgery.

Based on a voluntary registry, founded by the German Society for Thoracic and Cardiovascular Surgery (DGTHG) in 1980, a well-defined but limited dataset of all cardiac and vascular surgery procedures performed in 77 German heart surgery departments is reported annually. For the year 2023, a total of 168,841 procedures were submitted to the registry. Of these operations, 100,606 are defined as heart surgery procedures in a classical sense. The unadjusted in-hospital survival rate for the 28,996 isolated coronary artery bypass grafting procedures (relationship on-/off-pump 2.8:1) was 97.6%; 97.7% for the 39,859 isolated heart valve procedures (23,727 transcatheter interventions included); and 99.2% for 19,699 pacemaker/implantable cardioverter defibrillator procedures. Concerning short and long-term mechanical circulatory support, a total of 2,982 extracorporeal life support/extracorporeal membrane oxygenation implantations and 772 ventricular assist device implantations (left/right ventricular assist device, BVAD, total artificial heart) were reported. In 2023, 324 isolated heart transplantations, 248 isolated lung transplantations, and 2 combined heart-lung transplantations were performed. This annually updated registry of the DGTHG represents nonrisk adjusted voluntary public reporting and encompasses acute data for nearly all heart surgical procedures in Germany. It constitutes trends in heart medicine and represents a basis for quality management (e.g., benchmark) for all participating institutions.

New Legal Basis for International Risk Assessment Procedures in Germany: ICAP, ETACA

The new section 89b of the German Fiscal Code finally introduces a legal basis for international risk assessment procedures. Under these procedures, which are designed for cooperation and transparency, the tax administrations of two or more jurisdictions must at the request of the taxpayer provide an assessment of any tax default risks for facts already realized. If the risk is assessed as low, a formal review of these facts in a subsequent tax audit may be redundant.

In-hospital mortality following catheter ablation procedures in Germany: insights from the VARY project

Abstract Background The number of catheter ablation (CA) procedures has increased significantly over the last decade. 102,737 CA have been performed in Germany in 2021. Although CA of different types of arrhythmias is generally considered to be safe, serious complications, including in-hospital death, may occur. There is a paucity of real-world national healthcare data in Germany. Aim To investigate the overall in-hospital mortality in patients undergoing any type of CA procedure in Germany and to identify variables associated with in-hospital mortality. Methods According to the German law German hospitals are obliged to provide a dataset including case data, diagnosis based on the ICD-10-GM, operational and procedural codes to the Institute for hospital remuneration system (InEK) every year. The VARY project aims at analyzing and monitoring these data to report the real world scenario on patients undergoing CA in Germany. As of now, 22 German centers were contacted by the Institute for Myocardial Infarction Research (IHF). Their Data between 2019 and 2023 provided from seven of those centers were used for this analysis. Datasets from ten centers are pending. Five centers were not able to provide their data. The project is supported by the German Heart Foundation. Results A total 21,028 patients underwent inpatient CA. 49 patients (69.4% males) died in-hospital following a CA procedure resulting in an overall in-hospital mortality rate of 0.23%. A percutaneous epicardial ablation approach was used in 6.1% of the patients who died (Group A) compared to 0.3% in the surviving patients (Group B). Radiofrequency ablation was used in 83.7% vs. 72.6%, cryoablation in 10.2% vs 27.1%. Patients who died were older compared to those who survived (mean age: 66.7 ± 14.6 vs. 62.0 ± 14.4 years, p <0.01) and had more comorbidities such as diabetes (19/49 (38.8.%) vs. 2274/20,979 (10.8%), p <0,01), chronic obstructive pulmonary disease (5/49 (10.2%) vs. 555/20,979 (2.6%), p < 0,01) and heart failure (39/49 (79.6%) vs. 5116/20,979 (24.4%), p <0.01). There was no difference with regards to gender between the two groups. The most common arrhythmia in both groups was atrial fibrillation with 67.3% and 75.3% (p < 0.01). Cardiac arrest was observed in 44.9% of patients in group A compared to only 0.3% in group B. The median hospital stay was longer in group A (19.0 (IQR 8.0; 42.0) vs. 2.0 (IQR 1.0; 3.0), p < 0.01). 46/49 (93.9%) patients who died were treated on an intensive care unit for a median time of 13.5 days (IQR 3.8; 33.8) compared to 1272/20,979 (6.1%) (p < 0.01) in group B. A cardiac implantable electronic device implantation or revision was performed in 18.4% patients in group A (4 defibrillator implantations, 2 pacemaker implantations, 5 revisions) compared to 2.9% in group B (survivors). Conclusion Inpatient catheter ablation procedures in Germany are associated with a very low in-hospital mortality comparable to data reported from the US.

Descemet’s membrane endothelial keratoplasty is the predominant keratoplasty procedure in Germany since 2016: a report of the DOG-section cornea and its keratoplasty registry

Background/aimsThis retrospective multicentric panel study provides absolute numbers, types of and indications for corneal transplantation in Germany from 2011 to 2021 and sets them into the international context.MethodsA questionnaire was...

Availability in ECMO Reduces the Failure to Rescue in Patients With Pulmonary Embolism After Major Surgery: A Nationwide Analysis of 2.4 Million Cases.

Postoperative pulmonary embolism (PE) is a rare but potentially life-threatening complication, which can be treated with extracorporeal membrane oxygenation (ECMO) therapy, a novel therapy option for acute cardiorespiratory failure. We postulate that hospitals with ECMO availability have more experienced staff, technical capabilities, and expertise in treating cardiorespiratory failure. A retrospective analysis of surgical procedures in Germany between 2012 and 2019 was performed using hospital billing data. High-risk surgical procedures for postoperative PE were analyzed according to the availability of and expertise in ECMO therapy and its effect on outcome, regardless of whether ECMO was used in patients with PE. Descriptive, univariate, and multivariate analyses were applied to identify possible associations and correct for confounding factors (complications, complication management, and mortality). A total of 13,976,606 surgical procedures were analyzed, of which 2,407,805 were defined as high-risk surgeries. The overall failure to rescue (FtR) rate was 24.4% and increased significantly with patient age, as well as type of surgery. The availability of and experience in ECMO therapy (defined as at least 20 ECMO applications per year; ECMO centers) are associated with a significantly reduced FtR in patients with PE after high-risk surgical procedures. In a multivariate analysis, the odds ratio (OR) for FtR after postoperative PE was significantly lower in ECMO centers (OR, 0.75 [0.70-0.81], P < 0.001). The availability of and expertise in ECMO therapy lead to a significantly reduced FtR rate of postoperative PE. This improved outcome is independent of the use of ECMO in these patients.

PRE-TRIAL ADMINISTRATIVE DISPUTES RESOLUTION IN GERMANY, FRANCE, ITALY AND UKRAINE: COMPARATIVE ASPECT

Background. This article highlights the main issues of the introduction and legislative approach to regulation of pre-trial administrative disputes resolution in Ukraine together with some examples from such European countries as Germany, France and Italy. Relevance of the contemplated study is that there is no exact definition of the concept "pre-trial administrative disputes resolution" in Ukrainian legislation, and there is also a lack of a clear understanding of the essence of pre-trial procedures in Ukraine. The purpose of the research is to analyze the existing practice of legal regulation regarding similar procedures in European countries of Romano-Germanic legal group as Germany, France and Italy and to define their effectiveness as well as to discuss the necessity of their being borrowed by Ukraine. Methods. The methodological bases for the article are general and special methods of legal science, namely: the method of analysis, the method of synthesis, formal and logical, normative and dogmatic, comparative methods. Results. It has been concluded that mediation and pre-trial administrative disputes resolution are different legal procedures both in Ukraine and in the legal practice of above-mentioned states. A brief description of the new institution for pre-trial dispute resolution in Ukraine – the complaint review commission – is offered. An illustrative comparative study of pre-trial dispute resolution procedures in Germany, France and Italy including an administrative complaint, objection to administrative act, remonstration, conciliation, extraordinary appeal, arbitration and examples of its application regarding administrative cases is observed. A brief description of the legal rules of Germany, France and Italy establishing mandatory pre-trial tax disputes resolution, disputes in the field of public service and disputes in the field of social guarantees is also provided. Conclusions. The unequivocal need for the national legislature to apply the experience of legislative regulation and practice of mentioned countries regarding establishment of mandatory procedures for pre-trial administrative disputes resolution, in particular, tax disputes, is justified; the need for qualitative improvement and broader legal regulation of administrative appeal in Ukraine is confirmed; impracticality of establishing mandatory mediation in certain categories of administrative disputes before bringing an action to the administrative court is explained.

Trends in Selective Internal Radiation Therapy (SIRT) for Treating Hepatocellular Carcinoma, Cholangiocarcinoma, and Liver Metastasis: A Total Population Analysis from 2006 to 2021 in Germany.

The aim of this study was to investigate trends in selective internal radiation therapy (SIRT) for hepatocellular carcinoma (HCC), cholangiocarcinoma (CCC), and liver metastasis in Germany. We analyzed the nationwide German hospital billing database from 2006 to 2019 for the diagnosis of HCC, CCC or liver metastasis in combination with SIRT. For analyses of SIRT on the hospital level, we used the reimbursement.INFO tool based on German hospitals' quality reports from 2008 to 2021. Linear regression analysis was performed to detect changes over time. We included a total of 14,165 SIRT procedures. The annual numbers increased from 99 in 2006 to 1605 in 2015 (p < 0.001; increase by 1521%), decreasing to 1175 cases in 2019 (p < 0.001). In 2008, 6 of 21 hospitals (28.6%) performed more than 20 SIRTs per year, which increased to 19 of 53 (35.8%) in 2021. The share of SIRT for HCC increased from 29.8% in 2006 to 44.7% in 2019 (p < 0.001) and for CCC from 0% in 2006 to 9.5% in 2019 (p < 0.001), while the share of SIRT for liver metastasis decreased from 70.2% in 2006 to 45.7% in 2019 (p < 0.001). In-hospital mortality was 0.2% after the SIRT procedure. Gastritis (2.7%), liver failure (0.4%), and sepsis (0.3%) were the most common in-hospital complications reported. We observed an increase in SIRT procedures in Germany, with the number of hospitals offering the procedure going up from 21 in 2008 to 53 in 2021. While the treatment of liver metastasis remains the most common indication, SIRT for HCC and CCC increased significantly over the last few years. The mortality and complication rates show that SIRT is a relatively safe procedure.

In-hospital safety of catheter based left atrial appendage closure in Germany 2016 - 2020

Abstract Background New catheter based left atrial appendage (LAA) occlusion devices were introduced in the past decade. Catheter based LAA occlusion can be performed through a permanently implanted intracardiac LAA occlusion device or a loop stitch around the base of the LAA via an additional pericardial access. Knowledge about recent in-hospital safety trends and center volume dependent outcomes is limited. Methods Catheter based LAA closures in Germany were identified via ICD and OPS codes from 2016 - 2020. Adjusted risk differences for loop stitch procedures were calculated using an inverse probability weighting approach taking into account 17 predefined baseline characteristics. Center volume dependent outcomes were calculated using a risk adjusted logistics regression analysis taking into account the same predefined baseline characteristics. Results 28 039 permanently intracardiac implanted LAA occlusion device procedures and 213 loop stitch LAA occlusions were performed from 2016 - 2020. Numbers of permanently implanted occlusion device procedures increased from 5 259 in 2016 to 5 917 in 2020 (p = 0.020) without a significant trend for in-hospital safety parameters. Risk adjusted logistic regression analysis of center volume depended MACCE and pericardial puncture for permanently implanted occlusion devices did not show a significant trend. Patients receiving the loop stitch procedure were younger (76.17 +/- 8.16 vs. 73.16 +/- 8.99, p &amp;lt; 0.001), had a lower comorbidity index (2.29 +/- 1.93 vs. 1.92 +/- 1.64, 0.005) and less previous myocardial infarctions (7.82 % vs. 3.29 %, p = 0.014) or cardiac surgeries (12.34 % vs. 6.57 %, p = 0.011). Adjusted risk difference of pericardial effusion (8.04 %; 95% CI: 3.01 % – 13.08 %; p = 0.002) and pericardial puncture (6.60 %; 95% CI: 3.85 % – 9.35 %; p &amp;lt; 0.001) was higher for the LAA loop stitch procedure, while risk of bleeding (-1.85 %; 95% CI: -3.01 % to -0.69 %; p = 0.002), intracerebral bleeding (-0.37 %; 95% CI: -0.59 % to -0.15 %; p = 0.001) and shock (-1.41 %; 95% CI: -2.44 % to -0.39 %; p = 0.007) was lower. No significant difference was observed for in-hospital MACCE. Conclusions Permanently implanted occlusion devices were the major catheter based LAA closure procedure in Germany without improvements in in-hospital safety from 2016 – 2020. Center volumes did not influence in-hospital MACCE and pericardial puncture for the permanently implanted LAAC devices. LAA loop stitch occlusion was used much less frequently and was associated with a higher risk of pericardial effusion and pericardial puncture, a lower risk of bleeding and shock and no significant risk difference in MACCE.

Anticoagulatory treatment and clinical outcomes after transcatheter aortic valve implantation: results from 45,598 patients of the German Aortic Valve Registry (GARY)

Abstract Background Transcatheter aortic valve implantation (TAVI) has developed to the therapy of choice for patients with symptomatic severe aortic stenosis who are inoperable or at high or intermediate operative risk for surgical aortic valve replacement. However, the optimal anticoagulant therapy post-TAVI still remains a matter of debate and individual patient characteristics and comorbidities lead to the prescription of different regimens in clinical practice. Purpose This study investigates current anticoagulant treatment patterns and clinical outcomes in patients after TAVI in a real-world population. Methods The German Aortic Valve Registry (GARY) is a prospective, multicenter all-comers registry enrolling patients undergoing invasive treatment for aortic valve disease. From January 2011 to December 2019, 141,790 patients from 92 hospitals performing TAVI procedures in Germany were enrolled. Different anticoagulant treatment regimens were assessed at hospital discharge for patients after TAVI procedures. All-cause mortality and the combined endpoint "cardiac and cerebrovascular events" containing myocardial infarction (MI), stroke, transient ischaemic attack (TIA), aortic prosthesis re-intervention and all-cause mortality in the first year after TAVI were examined by treatment regimen. Results The study population comprised 45,598 patients with TAVI between 2011 and 2019: 46.5 % received dual antiplatelet therapy (DAPT), 25.7 % oral anticoagulation (OAC) plus antiplatelet therapy, 15.0 % single antiplatelet therapy (SAPT), 6.8 % OAC monotherapy, 4.7 % triple therapy and 1.3 % did not receive any anticoagulant medication. The majority of patients with oral anticoagulation were prescribed VKA (66.8 %) compared to DOAC (33.2 %). After adjustment for baseline confounders, cardiac and cerebrovascular event free survival did not differ significantly between patients with SAPT and DAPT (HR 0.94, 95% CI 0.89-1.00, p = 0.07), albeit the risk of all-cause mortality was slightly increased in SAPT (HR 1.24, 95% CI 1.12-1.37, p &amp;lt;0.001) and all regimens containing oral anticoagulation (OAC mono: HR 1.24, 95% CI 1.08-1.42, p = 0.002, OAC duo: HR 1.23, 95% CI 1.13-1.35, p &amp;lt; 0.001, OAC triple: HR 1.25, 95% CI 1.08-1.45, p = 0.003) compared to dual antiplatelet regime. In patients with OAC, the risk of all-cause mortality (HR 0.99, 95% CI 0.89-1.10, p = 0.81) and cardiac and cerebrovascular event free survival (HR 1.07, 95% CI 0.97-1.18, p = 0.17) was not significantly different in patients with DOAC-containing regimens when compared to VKA-containing regimens. Conclusions In an analysis from one of the world’s largest national registries of patients undergoing TAVI, we found comparative effectiveness of SAPT vs. DAPT and DOACs vs. VKA after TAVI with respect to cardiac and cerebrovascular events. The increased risk of all-cause mortality in patients with antiplatelet monotherapy might be confounded by unmeasured morbidity but requires further attention.Multivariate: Reference group DAPTMultivariate: Reference group VKA

Barriers to abortion provision: A qualitative study among medical students and gynecologists in Berlin, Germany

While abortion is a common medical procedure in Germany, the number of abortion-providing facilities declined by 46% between 2003 and 2022. As existing data do not paint a complete picture of the factors influencing this decline, an understanding into the perspectives of health care professionals (HCPs) is necessary. We set out to examine attitudes of HCPs in Berlin, Germany towarddifferent aspects of abortionto identify barriers that might prevent them from providing abortions. We used a qualitative research design consisting of in-depth semistructured one-on-one interviews with 14 medical students and four gynecologists. We transcribed interviews verbatim and conducted qualitative content analysis. Many interviewees perceived abortion as a taboo and legally ambiguous intervention. They feared stigmatization when talking about or providing abortions, especially by fellow students or religious family members. Few participants objected to abortion provision on religious grounds. Some medical students underestimated the safety of abortion and overestimated the potential for side effects and complications. Medical students obtained their knowledge about abortion from various sources, such as media, religious school education, or personal experience with abortion; the topic was rarely discussed in their medical education. To decide whether to provide abortions later, many students wished for detailed abortion teaching during medical school and residency. Fear of stigmatization, misconceptions on abortion, and religious beliefs reduced HCPs' willingness to perform abortions. Abortion education was widely valued by medical students and could address some of the barriers to abortion provision we found in this study. Universities and teaching hospitals should systematically teach about abortion to counteract misinformation and help normalize abortions among HCPs. Moreover, political decision-makers should take measures in order to destigmatize abortion, like an abortion regulation outside the Criminal Code in line with international public health recommendations.

Is cross-sectional imaging necessary for fractures of the distal lower leg in children and adolescents: results of a nationwide survey.

In childhood and adolescence, cross-sectional imaging, most commonly computed tomography (CT), is often performed for advanced diagnosis of joint injuries of the distal lower leg and upper ankle. Due to radiation exposure, the need for CT remains controversial, as these injuries follow stereotypies and usually have a similar course. Alternatively, the performance of magnetic resonance imaging (MRI) is also discussed. Since radiation sensitivity at this young age is much higher than in adults, an effort must be to minimize radiation exposure according to as low as reasonably achievable (ALARA) principles. The aim of this survey is to evaluate the current procedure in Germany in the diagnosis of pediatric injuries of the distal lower leg and upper ankle. For data collection, a survey entitled "CT in fractures of the ankle joint in childhood and adolescence: subject of the survey are injuries between 8 and 15years of age" of the Section of Pediatric Traumatology in the German Association of Trauma Surgery was sent to all members via the distribution list of the German Society of Orthopedics and Traumatology and the distribution list of the German Society of Pediatric Surgery in a period from September 20, 2022-December 21, 2022. The survey included a total of 21 questions. Target groups were trauma and pediatric surgeons and orthopedic surgeons working in the hospital and in practice. A total of 525 participants took part in the survey: ultrasound diagnostics are used by almost 25% and the Ottawa Ankle Rules by over 50% always or in most cases. A conventional x-ray is always or most often used by over 90%. CT imaging is rarely used by 88.57%, mainly for surgical planning or analysis of fracture progression. 69.9% report that their radiology department uses a pediatric protocol for CT exams; 25.71% do not know if this is the case. MRI imaging is also used infrequently by 89.33%, mostly to identify associated injuries. Overall, CT imaging is chosen by 55.62% and MRI imaging by 35.24% as the sectional imaging modality for suspected fractures; 95.05% consider sectional imaging useful for a triplane fracture, 59.24% for a two-plane fracture, 41.71% for a Salter-Harris type III/IV injury, and 8% for a Salter-Harris type I/II injury. The survey showed that the conventional X-ray is still the gold standard. Interestingly, more than half of the respondents regularly use the Ottawa Ankle Rules, and diagnostics using ultrasound are also used by almost a quarter. Awareness of radiation protection in children exists, although a quarter of all participants do not know the extent to which their radiology department has a specific pediatric protocol for CT imaging. Cross-sectional imaging is performed on a regular basis. Regarding the actual extent of imaging, there is a clear divergence between theory and practice.

A cross-sectoral approach to utilizing health claims data for quality assurance in medical rehabilitation: study protocol of a combined prospective longitudinal and retrospective cohort study

BackgroundMeasuring the quality of provided healthcare presents many challenges, especially in the context of medical rehabilitation. Rehabilitation is based on a holistic biopsychosocial model of health that includes a person’s long-term functioning; hence, outcome domains are very diverse. In Germany, rehabilitation outcomes are currently assessed via patient and physician surveys. Health insurance claims data has the potential to simplify current quality assurance procedures in Germany, since its comprehensive collection is federally mandated from every healthcare provider. By using a cross-sectoral approach, quality assessments in rehabilitation can be adjusted for the quality provided in previous sectors and individual patient risk factors.MethodsSEQUAR combines two studies: In a prospective longitudinal study, 600 orthopedic rehabilitation patients and their physicians are surveyed at 4 and 2 time points, respectively, throughout rehabilitation and a follow-up period of 6 months. The questionnaires include validated instruments used in the current best-practice quality assurance procedures. In a retrospective cohort study, a nationwide claims database with more than 312,000 orthopedic rehabilitation patients will be used to perform exploratory analysis for the identification of quality indicators. The identified SEQUAR claims data quality indicators will be calculated for our prospective study participants and tested for their ability to approximate or replace the currently used, best-practice quality indicators based on primary data.DiscussionThe identified SEQUAR quality indicators will be used to draft a novel, state-of-the-art quality assurance procedure that reduces the administrative burden of current procedures. Further research into the applicability to other indications of rehabilitation is required.Trial registrationWHO UTN: U1111-1276-7141; DRKS-ID: DRKS00028747 (Date of Registration in DRKS: 2022/08/10).

Catheter based left atrial appendage closure in-hospital outcomes in Germany from 2016 to 2020

BackgroundNew and refined catheter based left atrial appendage (LAA) closure devices have been introduced in the past decade. The procedure can be performed using either an endocardial occlusion device or an epicardial loop stitch. We aimed to analyzed recent procedural safety.MethodsCatheter based LAA closures were identified in a complete nationwide German dataset via ICD and OPS codes from 2016 to 2020.ResultsFrom 2016 to 2020, 28,039 endocardial and 213 epicardial occlusions were performed. Numbers of endocardial procedures increased from 5259 in 2016 to 5917 in 2020 (p = 0.020) in 387 centers with shifting of patients’ characteristics towards older age (β = 0.29, p < 0.001), more heart failure (β = 1.01, p < 0.001) and renal disease (β = 0.67, p = 0.001) and without a significant trend for in-hospital safety except more bleeding (β = 0.12, p = 0.05). In-hospital major adverse cardiac and cerebrovascular events (MACCE) or pericardial puncture were independent on center procedure numbers.The loop stitch procedure was performed in 15 centers. Patients were younger (76.17 ± 8.16 vs. 73.16 ± 8.99, p < 0.001) and had a lower comorbidity index (2.29 ± 1.93 vs. 1.92 ± 1.64, p = 0.005). Adjusted risk difference for pericardial effusion (8.04%; 95% CI 3.01–13.08%; p = 0.002) and pericardial puncture (6.60%; 95% CI 3.85–9.35%; p < 0.001) was higher for the loop stitch procedure, while risk of bleeding (− 1.85%; 95% CI − 3.01 to − 0.69%; p = 0.002), intracerebral bleeding (− 0.37%; 95% CI − 0.59 to − 0.15%; p = 0.001) and shock (− 1.41%; 95% CI − 2.44 to − 0.39%; p = 0.007) was lower. No significant difference was observed for in-hospital MACCE.ConclusionsEndocardial occlusion was the major catheter based LAA closure procedure in Germany without improvements in in-hospital safety from 2016 to 2020. In-hospital MACCE was independent on endocardial LAAC center volumes. Conclusions on the comparison between the two procedure types must be made cautious as the LAA loop stitch occlusion was utilized limited in a minor number of centers.Graphical abstractCatheter based left atrial appendage closure in-hospital outcomes in Germany from 2016 to 2020

Demonstrating the possibility of safe operation in the first phase of the site selection procedure in Germany

Abstract. The Federal Company for radioactive waste disposal (BGE) is responsible for the search for a site with the best possible safety for the disposal of high-level radioactive waste in Germany. The site selection procedure is regulated in a law that was adopted by the German Federal Parliament (Repository Site Selection Act – StandAG, 2017, last updated 2020 (StandAG)) and aims to be a participatory, transparent, learning, and self-questioning process based on scientific expertise. The first step of the first phase of the site selection procedure was completed in September 2020 and resulted in the identification of sub-areas that give reason for expecting favourable geological conditions for the long-term storage of nuclear waste in the sub-surface. These sub-areas cover approximately 54 % of Germany and are located in three different host rocks: rock salt–halite, claystone, and crystalline rock. The challenge for the next step is to find suitable siting regions within the previously determined sub-areas that are then considered further in the next phase of the site selection procedure (Hoyer et al., 2021). The preliminary representative safety analyses in Phase I, Step 2 of the site selection procedure require according to Section 7 (6) No. 4 EndlSiUntV that “the basic possibility of safe operation shall be demonstrated, but a complete operational safety analysis does not need to be performed”. The method is described in BGE (2022a, b) and can be summarized as follows. The demonstration of the basic possibility of safe operation is carried out within the framework of the representative safety analyses for the individual aspects of operational safety in different degrees of detail. The non-radiological aspects of operational safety, which are, for example, derived from occupational health and safety, mining law and fire protection, a site-independent consideration of the regulatory basis and the derivation of corresponding actions, are considered requirements for and are taken into account by the preliminary repository design according to Sect. 6 (4) EndlSiUntV. To demonstrate the basic possibility of safe operation for the operational safety aspects “radiation protection” and “release of radioactive substances” in the investigation areas to be considered, a general catalogue is compiled that summarizes possible events and actions to fulfill the requirements for operational safety. This general catalogue is independent of location and coverage of all host rocks and repository concepts. From this general catalogue, possible specific events are identified for each individual investigation area, and the necessary actions are derived. In addition to the demonstration of the basic possibility of safe operation, the robustness of operational safety within the investigation area is evaluated in a second step.

Evaluation of retrieval concepts for high-level radioactive waste from a deep geological disposal in operation

Abstract. This research project evaluates retrieval concepts. For this purpose, an evaluation method for assessing retrieval concepts is developed. Safety-relevant criteria for the evaluation of individual retrieval measures and the technically necessary components have to be identified. The criteria are developed on the basis of generic, host-rock-specific concepts. Different national and international retrieval concepts are considered. Different repository concepts (host rocks and technical concepts) require different retrieval concepts. The influences and effects of implementing the requirement for retrievability must already be identified and evaluated in the scope of the representative preliminary safety assessment (rvSU) included in the site selection procedure in Germany. This requires a suitable evaluation method that facilitates an assessment and classification of the different concepts, based on their measures for retrievability and their safety-related impacts. Both host-rock-specific requirements and different emplacement concepts (borehole and drift emplacement) must be considered. The BASE (German Federal Office for the Safety of Nuclear Waste Management) research project “Evaluation of Retrieval Concepts” (BeRK) addresses the following research questions: how could different retrievability measures and specific retrieval concepts be comparatively evaluated? How can measures for implementing and optimising retrievability be assessed in terms of their safety significance? How can trade-offs be reconstructed? The criteria to be developed and their derivation are to be presented in a comprehensible manner and are compiled in a criteria catalogue. The research project contributes to a better understanding of the repository designs with regard to a possible retrievability and allows for better assessments regarding the preliminary safety assessments.

Comparison of calculation models for flexural capacity of RC beams strengthened with TRC in China and Germany

AbstractThe new innovative composite material textile reinforced concrete (TRC) has been intensively investigated in Germany since the end 1990s. It has become increasingly important in the construction industry. Compared with conventional steel reinforcement, TRC has advantages such as higher load‐bearing capacity, higher strength‐to‐weight ratio, better ductility, and non‐corrosive behavior. This made them a subject of extensive research and diverse applications both nationally and internationally. In 2004, Xu et al. started research on bond properties of TRC in China in cooperation with Hans‐Wolf Reinhardt et al. from the University of Stuttgart in Germany. Since then, there have been numerous researches on TRC in China. This article introduces a calculation method for the flexural capacity of reinforced concrete (RC) beams strengthened with TRC in China. For comparison, the dimensioning procedure in Germany is also presented. Subsequently, the two models are compared with each other in a case study. Both models in China and Germany have the same mathematical background and also provide similar results. However, they have some differences in definitions of material characteristics (e.g., design concrete compressive strength, strain, and stress distribution) and consideration of the damage resulting from the preloading stage.