German University Hospitals Research Articles

The COVID-19 pandemic and its impact on medical teaching in obstetrics and gynecology-A nationwide expert survey among teaching coordinators at German university hospitals.

PurposeThe COVID-19 pandemic has imposed severe challenges on medical education at German university hospitals. In this first German nationwide expert survey, we addressed the responsible university teaching coordinators in obstetrics and gynecology departments and investigated their experiences during the pandemic as well as their opinions on future developments, especially with regard to the broader implementation of e-learning in the standard curriculum.MethodsThe questionnaire included 42 items and was disseminated among teaching coordinators at all 41 departments of obstetrics and gynecology at German university hospitals via an email that included a weblink to the online survey provider. Responses were collected between 19 April and 7 June 2021.ResultsIn total, 30 responses were collected from 41 departments across Germany and their respective teaching coordinators in obstetrics and gynecology. The general opinion of the medical teaching provided during the pandemic was positive, whereas the teaching quality in practical skills was considered inferior and not equivalent to the standard face-to-face curriculum. Lectures and seminars had to be substituted by remote-learning alternatives, while clinical clerkships were reduced in length and provided less patient contact. Students in their final year experienced only a few differences in the clinical and teaching routine. Teaching coordinators in obstetrics and gynecology stated that they intend to incorporate more e-learning into the curriculum in the future.ConclusionThe medical educators’ views presented here may help to complement the already-thoroughly investigated experiences of students under the restrictions of the COVID-19 pandemic. Medical educators in obstetrics and gynecology at German university hospitals have successfully established online and hybrid teaching alternatives to their standard face-to-face courses. Building on recent experiences, digitalization could help to improve future medical education.

Intraindividual Comparison Between [18F] PSMA-1007 PET/CT and Multiparametric MRI for Radiotherapy Planning in Primary Prostate Cancer Patients.

IntroductionAccurate detection and segmentation of the intraprostatic gross tumor volume (GTV) is pivotal for radiotherapy (RT) in primary prostate cancer (PCa) since it influences focal therapy target volumes and the patients’ cT stage. The study aimed to compare the performance of multiparametric resonance imaging (mpMRI) with [18F] PSMA-1007 positron emission tomography (PET) for intraprostatic GTV detection as well as delineation and to evaluate their respective influence on RT concepts.Materials and MethodsIn total, 93 patients from two German University Hospitals with [18F] PSMA-1007-PET/CT and MRI (Freiburg) or [18F] PSMA-1007-PET/MRI (Dresden) were retrospectively enrolled. Validated contouring techniques were applied for GTV-PET and -MRI segmentation. Absolute tumor volume and cT status were determined for each imaging method. The PCa distribution from histopathological reports based on biopsy cores and surgery specimen was used as reference in terms of laterality (unilateral vs. bilateral).ResultsIn the Freiburg cohort (n = 84), mpMRI and PET detected in median 2 (range: 1–5) and 3 (range: 1–8) GTVs, respectively (p < 0.01). The median GTV-MRI was significantly smaller than the GTV-PET, measuring 2.05 vs. 3.65 ml (p = 0.0005). PET had a statistically significant higher concordance in laterality with surgery specimen compared to mpMRI (p = 0.04) and biopsy (p < 0.01), respectively. PSMA PET led to more cT2c and cT3b stages, whereas cT3a stage was more pronounced in mpMRI. Based on the cT stage derived from mpMRI and PET information, 21 and 23 as well as 59 and 60 patients, respectively, were intermediate- and high-risk according to the National Comprehensive Cancer Network (NCCN) v1.2022 criteria. In the Dresden cohort (n = 9), similar results were observed.ConclusionIntraprostatic GTV segmentation based on [18F] PSMA-1007 PET results in more and larger GTVs compared to mpMRI. This influences focal RT target volumes and cT stage definition, but not the NCCN risk group.

The OUTREACH study: oncologists of German university hospitals in rotation on a palliative care unit—evaluation of attitude and competence in palliative care and hospice

PurposeThe effect of the duration of an educational rotation presented at a palliative care unit on the palliative care knowledge gain and the increase of palliative care self-efficacy expectations are unclear.MethodsThis national prospective multicenter pre–post survey conducted at twelve German University Comprehensive Cancer Centers prospectively enrolled physicians who were assigned to training rotations in specialized palliative care units for three, six, or twelve months. Palliative care knowledge [in %] and palliative care self-efficacy expectations [max. 57 points] were evaluated before and after the rotation with a validated questionnaire.ResultsFrom March 2018 to October 2020, questionnaires of 43 physicians were analyzed. Physicians participated in a 3- (n = 3), 6- (n = 21), or 12-month (n = 19) palliative care rotation after a median of 8 (0–19) professional years. The training background of rotating physicians covered a diverse spectrum of specialties; most frequently represented were medical oncology (n = 15), and anesthesiology (n = 11). After the rotation, median palliative care knowledge increased from 81.1% to 86.5% (p < .001), and median palliative care self-efficacy expectations scores increased from 38 to 50 points (p < .001). The effect of the 12-month rotation was not significantly greater than that of the 6-month rotation.ConclusionAn educational rotation presented in a specialized palliative care unit for at least six months significantly improves palliative care knowledge and palliative care self-efficacy expectations of physicians from various medical backgrounds.

Respiratory viruses dynamics and interactions: ten years of surveillance in central Europe

BackgroundLower respiratory tract infections are among the main causes of death. Although there are many respiratory viruses, diagnostic efforts are focused mainly on influenza. The Respiratory Viruses Network (RespVir) collects infection data, primarily from German university hospitals, for a high diversity of infections by respiratory pathogens. In this study, we computationally analysed a subset of the RespVir database, covering 217,150 samples tested for 17 different viral pathogens in the time span from 2010 to 2019.MethodsWe calculated the prevalence of 17 respiratory viruses, analysed their seasonality patterns using information-theoretic measures and agglomerative clustering, and analysed their propensity for dual infection using a new metric dubbed average coinfection exclusion score (ACES).ResultsAfter initial data pre-processing, we retained 206,814 samples, corresponding to 1,408,657 performed tests. We found that Influenza viruses were reported for almost the half of all infections and that they exhibited the highest degree of seasonality. Coinfections of viruses are frequent; the most prevalent coinfection was rhinovirus/bocavirus and most of the virus pairs had a positive ACES indicating a tendency to exclude each other regarding infection.ConclusionsThe analysis of respiratory viruses dynamics in monoinfection and coinfection contributes to the prevention, diagnostic, treatment, and development of new therapeutics. Data obtained from multiplex testing is fundamental for this analysis and should be prioritized over single pathogen testing.

The COVID-19 Data Exchange Platform of the German University Medicine.

COVID-19 has challenged the healthcare systems worldwide. To quickly identify successful diagnostic and therapeutic approaches large data sharing approaches are inevitable. Though organizational clinical data are abundant, many of them are available only in isolated silos and largely inaccessible to external researchers. To overcome and tackle this challenge the university medicine network (comprising all 36 German university hospitals) has been founded in April 2020 to coordinate COVID-19 action plans, diagnostic and therapeutic strategies and collaborative research activities. 13 projects were initiated from which the CODEX project, aiming at the development of a Germany-wide Covid-19 Data Exchange Platform, is presented in this publication. We illustrate the conceptual design, the stepwise development and deployment, first results and the current status.

The Architecture of a Feasibility Query Portal for Distributed COVID-19 Fast Healthcare Interoperability Resources (FHIR) Patient Data Repositories: Design and Implementation Study.

BackgroundAn essential step in any medical research project after identifying the research question is to determine if there are sufficient patients available for a study and where to find them. Pursuing digital feasibility queries on available patient data registries has proven to be an excellent way of reusing existing real-world data sources. To support multicentric research, these feasibility queries should be designed and implemented to run across multiple sites and securely access local data. Working across hospitals usually involves working with different data formats and vocabularies. Recently, the Fast Healthcare Interoperability Resources (FHIR) standard was developed by Health Level Seven to address this concern and describe patient data in a standardized format. The Medical Informatics Initiative in Germany has committed to this standard and created data integration centers, which convert existing data into the FHIR format at each hospital. This partially solves the interoperability problem; however, a distributed feasibility query platform for the FHIR standard is still missing.ObjectiveThis study described the design and implementation of the components involved in creating a cross-hospital feasibility query platform for researchers based on FHIR resources. This effort was part of a large COVID-19 data exchange platform and was designed to be scalable for a broad range of patient data.MethodsWe analyzed and designed the abstract components necessary for a distributed feasibility query. This included a user interface for creating the query, backend with an ontology and terminology service, middleware for query distribution, and FHIR feasibility query execution service.ResultsWe implemented the components described in the Methods section. The resulting solution was distributed to 33 German university hospitals. The functionality of the comprehensive network infrastructure was demonstrated using a test data set based on the German Corona Consensus Data Set. A performance test using specifically created synthetic data revealed the applicability of our solution to data sets containing millions of FHIR resources. The solution can be easily deployed across hospitals and supports feasibility queries, combining multiple inclusion and exclusion criteria using standard Health Level Seven query languages such as Clinical Quality Language and FHIR Search. Developing a platform based on multiple microservices allowed us to create an extendable platform and support multiple Health Level Seven query languages and middleware components to allow integration with future directions of the Medical Informatics Initiative.ConclusionsWe designed and implemented a feasibility platform for distributed feasibility queries, which works directly on FHIR-formatted data and distributed it across 33 university hospitals in Germany. We showed that developing a feasibility platform directly on the FHIR standard is feasible.

Aligning Biobanks and Data Integration Centers Efficiently (ABIDE_MI).

ABIDE_MI is a complementary funded 18 months project within the German Medical Informatics Initiative (MII), which aims to align IT infrastructures and regulatory/governance structures between biobanks/biobanking IT and the MII data integration centres (DIC) at German university hospitals. A major task in 2021 was the systematic collection of all documents describing rules, as well as proposal/contract templates for data and biosample use and access at each of the participating 24 university hospitals and their comparison with MII-wide consented data sharing principles, documents and governance structures. This comparison revealed large heterogeneity across the ABIDE_MI sites and further, redundant structures/regulations currently established at the German university hospitals. A second task was the design and stepwise development of an IT network infrastructure with central components (data and biosample query portal) and decentralized standardized FHIR servers to capture the standardized FHIR-based core data set modules (resources) defined within the MII working group "Interoperability". Subsequent steps in the project are the harmonization of the data and biosample sharing governance/regulation frameworks at each ABIDE_MI site, creating synergies for the research infrastructures at the German university hospitals and to link those resources to the German Portal for Medical Research Data and with the BBMRI-ERIC Directory and Negotiator tools.

Evolving epidemiology of pneumocystis pneumonia: Findings from a longitudinal population-based study and a retrospective multi-center study in Germany.

SummaryBackgroundPneumocystis pneumonia (PCP) is a life-threatening opportunistic infectious disease of immunocompromised patients. Its incidence has decreased worldwide in the past, but data concerning its recent epidemiology are lacking.MethodsWe retrospectively analyzed all German inpatient cases from January 1, 2014 to December 31, 2019, to describe the recent epidemiology, incidence, clinical course, mortality and underlying diseases of PCP. Simultaneously, we conducted a retrospective multi-center study at two German university hospitals, and analyzed PCP cases treated there to gain deeper insights on the basis of primary patient data.FindingsThe incidence of PCP significantly increased from 2·3 to 2·6 per 100,000 population from 2014 to 2019 (1,857 to 2,172 cases, +17·0%, p < 0·0001), as well as PCP-related deaths (516 to 615 cases, +19·2%, p = 0·011). The spectrum of underlying diseases changed: Risk groups with established chemoprophylaxis for PCP based on international guidelines (HIV, hematologic malignancies, and transplantation) showed a significant decrease in PCP cases and deaths. Others, especially those with solid malignancies, and autoimmune and pulmonary diseases showed a significant increase in case numbers and deaths. Data from the retrospective multi-center study added information regarding prophylaxis and diagnostics of PCP.InterpretationThe incidence of PCP has reversed its trend, showing a significant increase in mortality on population level. Patients who were not previously considered in prophylactic measures are increasingly affected by PCP. This development deserves further investigation, and additional comprehensive guidelines for the use of chemoprophylaxis in new risk groups are needed.FundingDepartment of Nephrology and Hypertension, University Hospital Schleswig-Holstein, Kiel.

MO149: Effect of Plasma Exchange on COVID-19 Associated Excess of Von Willebrand Factor and Inflammation in Critically Ill Patients

BACKGROUND AND AIMSUbiquitous microthromboses in the pulmonary vasculature play a crucial role in the pathogenesis of COVID-19 associated acute respiratory distress syndrome (ARDS). Excess of von Willebrand factor (vWf) with intravascular multimer formation was identified as a key driver of this finding. Plasma exchange (PLEX) might be a therapeutic option to restore the disbalance between vWf and ADAMTS13. We report the effects of PLEX on vWf, ADAMTS13, inflammatory cytokines and parameters of ventilation.METHODWe investigated 25 patients, who were on mechanical ventilation for COVID-19 pneumonia with ARDS at two German university hospitals. All patients received PLEX as an ultima ratio measure for refractory ARDS. VWf antigen (vWf: Ag), ADAMTS13 activity, a cytokine panel mirroring the inflammatory situation and clinical parameters were assessed before and after three to six PLEX therapies with fresh frozen plasma.RESULTSBefore the PLEX sequence, there was an excessive release of vWf: Ag (425.4 ± 167.5%) and mildly reduced ADAMTS13 activity (49.7 ± 23.3%). After the PLEX series, there was a significant increase of ADAMTS13 activity to 62.4 ± 17.7% (P = .029) and a significant decrease of vWf: Ag to 336.1 ± 138.2% (P = .041) resulting in a 63% improvement of the ADAMT13/vWf: Ag ratio from 14.5 ± 10.0 to 23.7 ± 14.6 (P = .024). Comparison of parameters before and after individual PLEX sessions (n = 35) revealed a mean reduction of vWf from 387.8 ± 165.1% to 213.2 ± 62.3% (P = .001) and an increase of ADAMTS13 activity from 60.4 ± 20.1% to 70.5 ± 14.0% (P = .001). Parallelly, monocyte chemotactic protein-1 and interleukin-18 decreased significantly (P = .034 each). Along the PLEX sequence lactate dehydrogenase (P = .001), C-reactive protein (P = .001), and positive end expiratory pressure (P = .01) significantly decreased accompanied by an improvement of Horovitz index (P = .001).CONCLUSIONPLEX restores the disbalance between ADAMTS13 and vWf: Ag, a driver of immunothrombosis. Moreover, it reduces the inflammatory state and is associated with a benefit of ventilation parameters. These findings render a further rationale to regard PLEX as a therapeutic option in severe COVID-19.

Antibiotic Prophylaxis and Empirical Antibiotic Therapy in Primary Arthroplasty and Periprosthetic Joint Infections: Current Practice and Need for Therapy Optimization.

The aim of the present work was to survey the situation of healthcare regarding the use of prophylactic and empirical antibiotics in primary arthroplasty and treatment of periprosthetic joint infections (PJI). For this purpose, a survey was conducted at German university and occupational accident hospitals. Survey data was compared to previously published data on the antimicrobial regimes of PJI (n=81) patients (n=81) treated in our department between 2017 and 2020. A homogeneous picture emerged for the prophylactic administration of antibiotics in the context of primary arthroplasty. In 93.2% (elective) and 88.6% (fracture treatment) of the hospitals, first or second generation cephalosporins were administered perioperatively for infection prophylaxis in primary hip arthroplasty. The empirical antibiotic treatment of PJIs showed a clearly inhomogeneous therapeutic picture. Monotherapy with an aminopenicillin plus a beta-lactamase inhibitor is used most frequently (38.7%); first and second generation cephalosporins are used second most frequently as monotherapy (18.2%). In light of the global problem of antibiotic multi-resistance, clinical use of antibiotics has to be reasonable and effective. The present results highlight the further need to improve awareness and following existing guidelines in the administration of empirical antibiotic therapy in PJI.

Patient Recruitment System for Clinical Trials: Mixed Methods Study About Requirements at Ten University Hospitals.

BackgroundClinical trials are the gold standard for advancing medical knowledge and improving patient outcomes. For their success, an appropriately sized cohort is required. However, patient recruitment remains one of the most challenging aspects of clinical trials. Information technology (IT) support systems—for instance, patient recruitment systems—may help overcome existing challenges and improve recruitment rates, when customized to the user needs and environment.ObjectiveThe goal of our study is to describe the status quo of patient recruitment processes and to identify user requirements for the development of a patient recruitment system.MethodsWe conducted a web-based survey with 56 participants as well as semistructured interviews with 33 participants from 10 German university hospitals.ResultsWe here report the recruitment procedures and challenges of 10 university hospitals. The recruitment process was influenced by diverse factors such as the ward, use of software, and the study inclusion criteria. Overall, clinical staff seemed more involved in patient identification, while the research staff focused on screening tasks. Ad hoc and planned screenings were common. Identifying eligible patients was still associated with significant manual efforts. The recruitment staff used Microsoft Office suite because tailored software were not available. To implement such software, data from disparate sources will need to be made available. We discussed concrete technical challenges concerning patient recruitment systems, including requirements for features, data, infrastructure, and workflow integration, and we contributed to the support of developing a successful system.ConclusionsIdentifying eligible patients is still associated with significant manual efforts. To fully make use of the high potential of IT in patient recruitment, many technical and process challenges have to be solved first. We contribute and discuss concrete technical challenges for patient recruitment systems, including requirements for features, data, infrastructure, and workflow integration.

Current situation of electronic medical records in ophthalmological departments in Germany

Electronic medical records are required in ophthalmology clinics to be integrated into digital care networks and efficient clinical registry databases. To assess the prevalence and methods of electronic medical recordkeeping in inpatient ophthalmological care in Germany. An online questionnaire was sent to all German university eye hospitals and ophthalmology departments in June 2021. It included13 open and closed option questions concerning current practices of digital recordkeeping, including the structure of data storage and the recording of billing-relevant codes in the departments. A total of 44 (44%) out of 100 clinics responded. Patient documentation was completely digital in15 (34%) clinics and partly digital and paper-based in the remaining29 (66%). A total of 16different constellations of documentation programs were specified. The most frequently used programs were Orbis (27%) (Dedalus HealthCare, Bonn, Germany), FIDUS (18%) (Arztservice Wente, Darmstadt, Germany), and SAP/i.s.h.med (16%) (SAP Deutschland, Walldorf, Germany; Cerner Deutschland, Berlin, Germany) and 3 clinics indicated primary use of paper records. Structured documentation of findings was performed in 61% of the departments, while 23% used asemistructured manner and 15% used anonstructured format. Electronic documents are stored as DICOM (Digital Imaging and Communications in Medicine) documents 20% of the clinics and as PDF (Portable Document Format) files in 34% of the clinics while 23% store scanned printouts. Methods of medical record keeping in German eye clinics are heterogeneous, with paper-based documentation continuing to play an important role. This, as well as the high number of different electronic medical record software pose important challenges in terms of interoperability and secondary use of clinical data.

Effect of plasma exchange on COVID-19 associated excess of von Willebrand factor and inflammation in critically ill patients

Ubiquitous microthromboses in the pulmonary vasculature play a crucial role in the pathogenesis of COVID-19 associated acute respiratory distress syndrome (ARDS). Excess of Willebrand factor (vWf) with intravascular multimer formation was identified as a key driver of this finding. Plasma exchange (PLEX) might be a therapeutic option to restore the disbalance between vWf and ADAMTS13. We report the effects of PLEX on vWf, ADAMTS13, inflammatory cytokines and parameters of ventilation. We investigated 25 patients, who were on mechanical ventilation for COVID-19 pneumonia with ARDS at two German university hospitals. All patients received PLEX as an ultima ratio measure for refractory ARDS. VWf antigen (vWf:Ag), ADAMTS13 activity, a cytokine panel mirroring the inflammatory situation and clinical parameters were assessed before and after three to six PLEX therapies with fresh frozen plasma. Before the PLEX sequence there was an excessive release of vWf:Ag (425.4 ± 167.5%) and mildly reduced ADAMTS13 activity (49.7 ± 23.3%). After the PLEX series, there was a significant increase of ADAMTS13 activity to 62.4 ± 17.7% (p = 0.029) and a significant decrease of vWf:Ag to 336.1 ± 138.2% (p = 0.041) resulting in a 63% improvement of the ADAMT13/vWf:Ag ratio from 14.5 ± 10.0 to 23.7 ± 14.6, p = 0.024. Comparison of parameters before and after individual PLEX sessions (n = 35) revealed a mean reduction of vWf from 387.8 ± 165.1 to 213.2 ± 62.3% (p = 0.001) and an increase of ADAMTS13 activity from 60.4 ± 20.1 to 70.5 ± 14.0% (p = 0.001). Parallelly, monocyte chemotactic protein-1 and interleukin-18 decreased significantly (p = 0.034 each). Along the PLEX sequence lactate dehydrogenase (p = 0.001), C-reactive protein (p = 0.001), and positive end expiratory pressure (p = 0.01) significantly decreased accompanied by an improvement of Horovitz index (p = 0.001). PLEX restores the disbalance between ADAMTS13 and vWf:Ag, a driver of immunothrombosis. Moreover, it reduces the inflammatory state and is associated with a benefit of ventilation parameters. These findings render a further rationale to regard PLEX as a therapeutic option in severe COVID-19.

Journal clubs in nursing practice: An online survey of German university hospitals

Journal clubs in nursing practice: An online survey of German university hospitals Abstract. Background: Journal clubs (JCs) are an evidence-based method for enabling nursing professionals to develop a scientifically based practice. Research results can be made available to nurses to directly influence their nursing practice. The level of implementation in German university hospitals is currently unknown. Aim: This study surveyed the current state of JCs at German university hospitals. The aim is to develop recommendations for the implementation of JCs for nursing practice. Methods: The online survey of all 27 representatives of the "Network of Nursing Science and Practice Development" of the VPU e.V. was conducted from October to November 2020. The questionnaire was developed based on literature. The data analysis was descriptive. Results: 15 of the 19 clinics surveyed currently implement, or have previously implemented, a JC (response rate 70,4%). In approximately half of the clinics, JC is an established structure that is also offered as part of advanced training and continuing education (46,6%) and is used to develop and expand methodological, scientific competencies (86,6%). Positive experiences, but also structural problems in the implementation of a JC were reported. Approximately one quarter of the clinics evaluate their JC regularly (26,7%). Conclusions: JCs at German university hospitals are currently being established. In order to establish JCs on a permanent basis, EBN knowledge must be continuously imparted in further education and training; in addition, JCs should be an essential component of academic role profiles.

Activation of Investigator-Initiated Clinical Trials with a Pharmaceutical for Cancer Patients before and after Post-Millennial Changes of Regulations in Germany and Europe.

Simple SummaryThis opinion paper describes the regulatory hurdles for a clinical oncologist and physician scientist to activate an Investigator-Initiated Trial (IIT) before and after 2004 with German regulation as an example. Changes in legal framework with impacts on time and costs to activate a clinical trial are described. Evidence needed to reach the objective of higher patient safety and trial quality by European Union (EU) Clinical Trial Directive (CTD) 2001/20 is discussed.Shortly after the beginning of the year 2000, multiple legal changes with impacts on the regulatory framework of clinical trials became effective almost simultaneously. They included the European Union (EU) Clinical Trial Directive (CTD) 2001/20 followed by major changes in national drug laws, the change in the legal status of German University Hospitals (1998), and a new disease-related groups (DRG)-based reimbursement system for hospitals in Germany (2000). Together, these changes created enormous bureaucratic and financial inhibition of activation and conduct of academic investigator-initiated clinical trials (IIT). Examples for activating clinical trials in oncology before and after 2004 are outlined and discussed, focussing on extended time frames, the establishment of centralized responsibility structures and the exploding financial consequences. In addition, the evolution of trial numbers and the distribution of trial initiators between “commercial” and “academic” over time are discussed together with the occurrence of clinical registries. At the same time, progress in molecular biology led to a plethora of new targets for effective pharmacological therapy of life-threatening diseases such as cancer, and the overall number of clinical trials has not decreased. Yet, judging the regulatory and administrative hurdles between scientific study design and first-patient on trial before and after 2004 and weighing these against the lack of evidence that this regulation has achieved its goal to enhance patient safety and trial quality, the necessity to completely overhaul this CTD becomes obvious. A main goal of such an initiative should be to minimize bureaucracy. For the specific situation in Germany, relocation of responsibility and freedom to operate in University Hospitals and Medical Faculties back to the physician–scientists and reduction in interference by legal divisions should be a goal as well as increasing the public financial support for IITs.

Dental Strain on Maxillary Incisors During Tracheal Intubation With Double-Lumen Tubes and Different Laryngoscopy Techniques - A Blinded Mannequin Study

To quantify dental forces during double-lumen tube intubations with different laryngoscopy techniques. Experimental biomechanical mannequin study. Two German university hospitals. One hundred four anesthesiologists with varying levels of experience. Participants performed a sequence of intubations on a mannequin equipped with hidden forces sensors in the maxillary incisors. Different laryngoscopy techniques were evaluated under normal and difficult airway conditions. Direct laryngoscopy was compared with different videolaryngoscopy techniques: the C-MAC with a Macintosh blade, the GlideScope, and the KingVision with hyperangulated blades. A total of 624 intubations were evaluated. In normal airway conditions, the median (interquartile range [range]) peak forces were significantly lower when the GlideScope (15.7 (11.3-22.0 [2.1-110.5]) N) was used compared with direct laryngoscopy (21.0 (14.1-28.5[4.7-168.6]) N) (p=0.007). In difficult airways, resulting forces were reduced using hyperangulated videolaryngoscopes (GlideScope: -13.7 N [p < 0.001]; KingVision: -11.9 N [p < 0.001]) compared with direct laryngoscopy, respectively. The time to intubation was prolonged with the use of the KingVision (25.5 (17.1-41.9[9.2-275.0])s [p < 0.001]) in comparison to direct laryngoscopy (20.8 (15.9-27.4[8.7-198.6]) s). The C-MAC demonstrated the shortest time to intubation. Although hyperangulated videolaryngoscopes improve dental strain, clinicians also should consider the time to intubation, which is shortest with nonhyperangulated videoblades, when choosing a laryngoscopy technique on an individual patient basis.

Birthing under the Condition of the COVID-19 Pandemic in Germany: Interviews with Mothers, Partners, and Obstetric Health Care Workers.

Background: The COVID-19 pandemic and the necessary containment measures challenge obstetric care. Support persons were excluded while protection measures burdened and disrupted the professionals’ ability to care and communicate. The objective of this study was to explore the first-hand experience of the impact of the COVID-19 pandemic on mothers, their partners, and obstetric professionals regarding birth and obstetric care in a university hospital. Methods: To answer the descriptive research questions, we conducted a qualitative content analysis using a data triangulation approach. We carried out 35 semi-structured interviews with two stratified purposive samples. Sample one consisted of 25 mothers who had given birth during the pandemic and five partners. Sample two included 10 obstetric professionals whose insights complemented the research findings and contributed to data validation. Participants were recruited from the study sample of a larger project on patient safety from two German university hospitals from February to August 2021. The study was approved by two ethics committees and informed consent was obtained. Results: Mothers complied with the rules, but felt socially isolated and insecure, especially before transfer to the delivery room. The staff equally reported burdens from their professional perspective: They tried to make up for the lack of partner and social contacts but could not live up to their usual professional standards. The exclusion of partners was seen critically, but necessary to contain the pandemic. The undisturbed time for bonding in the maternity ward was considered positive by both mothers and professionals. Conclusion: The negative effects of risk mitigation measures on childbirth are to be considered carefully when containment measures are applied.

Operative Volume of Newborn Surgery in German University Hospitals: High Volume Versus Low Volume Centers.

Adequate patient volume is essential for the maintenance of quality, meaningful research, and training of the next generation of pediatric surgeons. The role of university hospitals is to fulfill these tasks at the highest possible level. Due to decentralization of pediatric surgical care during the last decades, there is a trend toward reduction of operative caseloads. The aim of this study was to assess the operative volume of the most relevant congenital malformations at German academic pediatric surgical institutions over the past years. Nineteen chairpersons representing university-chairs in pediatric surgery in Germany submitted data on 10 index procedures regarding congenital malformations or neonatal abdominal emergencies over a 3-year period (2015 through 2017). All institutions were categorized according to the total number of respective cases into "high," "medium," and "low" volume centers by terciles. Some operative numbers were verified using data from health insurance companies, when available. Finally, the ratio of cumulative case load versus prevalence of the particular malformation was calculated for the study period. From 2015 through 2017, a total 2,162 newborns underwent surgery for congenital malformations and neonatal abdominal emergencies at German academic medical centers, representing 51% of all expected newborn cases nationwide. The median of cases per center within the study period was 101 (range 18-258). Four institutions (21%) were classified as "high volume" centers, four (21%) as "medium volume" centers, and 11 (58%) as "low volume" centers. The proportion of patients operated on in high-volume centers varied per disease category: esophageal atresia/tracheoesophageal fistula: 40%, duodenal atresia: 40%, small and large bowel atresia: 39%, anorectal malformations: 40%, congenital diaphragmatic hernia: 56%, gastroschisis: 39%, omphalocele: 41%, Hirschsprung disease: 45%, posterior urethral valves: 39%, and necrotizing enterocolitis (NEC)/focal intestinal perforation (FIP)/gastric perforation (GP): 45%. This study provides a national benchmark for neonatal surgery performed in German university hospitals. The rarity of these cases highlights the difficulties for individual pediatric surgeons to gain adequate clinical and surgical experience and research capabilities. Therefore, a discussion on the centralization of care for these rare entities is necessary.

Comparative effectiveness of natalizumab versus ocrelizumab in multiple sclerosis: a real-world propensity score-matched study.

For treatment of relapsing-remitting multiple sclerosis (RRMS), a broad range of disease-modifying therapies (DMT) is available. However, few comparative effectiveness studies between different drugs have been performed. This study aimed to compare the efficacy and treatment continuation of natalizumab and ocrelizumab in a real-world cohort of patients with relapsing-remitting multiple sclerosis (RRMS) from two German university hospitals. We performed a retrospective analysis of RRMS patients who initiated treatment with natalizumab or ocrelizumab between January 2016 and April 2019 at the German university hospitals of Mainz and Düsseldorf. Bayesian propensity score matching was conducted to correct for differences in baseline characteristics. Our primary outcome was no evidence of disease activity [NEDA-3: no relapses, no confirmed disability progression, and no magnetic resonance imaging (MRI) activity] and its subcomponents. Secondary outcomes included measurement of neurofilament light chain (NfL) in serum, analysis of premature discontinuation, and evidence of rebound activity in patients switching from natalizumab to ocrelizumab. We identified 63 patients starting treatment with natalizumab and 76 patients starting with ocrelizumab. Binary logistic regression showed that treatment with natalizumab or a higher number of relapses in the previous year were independently associated with a higher risk for relapses. Patients receiving natalizumab had a higher probability of premature discontinuation of therapy (p = 0.002). After propensity score matching of the two treatment arms, 55 patients remained per group. NEDA-3 after 30 months of follow-up was reached by 53.1% in the ocrelizumab group and 36.1% in the natalizumab group (p = 0.177). Ocrelizumab was superior to natalizumab concerning the occurrence of relapses in log-rank test (p = 0.019). NfL levels in serum were low under both treatments. Patients who switched from natalizumab to ocrelizumab showed no increased rebound activity. This study provides class IV evidence that treatment of RRMS patients with ocrelizumab and natalizumab show comparable effectiveness in combined endpoints, while ocrelizumab might be more effective in preventing the occurrence of relapses.

Prevalences of mental distress and its associated factors in unaccompanied refugee minors in Germany

Prevalences for mental disorders within minor refugees are comparatively high and heterogeneous. To reduce heterogeneity and identify high-risk subgroups, we compared unaccompanied refugee minors (URM) to accompanied refugee minors (ARM) regarding depressive symptoms and mental distress. Furthermore, we examined associative factors of mental distress in URM on a broad scale. We conducted a survey with a cross-sectional design in four German University hospitals. The sample consisted of n = 172 URM and n = 52 ARM aged 14–21. Depressive symptoms were assessed via the Patient Health Questionnaire (PHQ-9). Mental distress was assessed by the Refugee Health Screener (RHS-15). Mann–Whitney test was used to examine differences between URM and ARM. Associated factors of mental distress were evaluated via a stepwise multiple regression analysis. URM showed significantly higher mean scores for PHQ-9 (p < .001) and RHS-15 (p < .001) compared to ARM indicating medium effect sizes. Furthermore, URM were significantly more likely to surpass the cut-off for depression (61.6% vs. 30.8%) and overall mental distress (81.4% vs. 53.8%) compared to ARM. The factors Number of stressful life events (SLE), Female gender, and Fear of deportation were found to be associated with an increased mental distress in URM, whereas Weekly contact to a family member, School attendance, and German language skills were accompanied with lower distress scores. All six factors accounted for 32% of the variance of mental distress in URM (p < .001). Within minor refugees, URM are a highly vulnerable subgroup, which should receive particular attention and more targeted measures by health authorities. Our results indicate that these measures should comprise a rapid promotion of family contact, school attendance, language acquisition, and the fast processing of asylum applications. However, the cross-sectional design limits the interpretability of the results.