[Cross-sectional study of COVID-19 patients on working conditions and quality of care]. / Querschnittsstudie zu Arbeitsbedingungen und Versorgungsqualität in der Versorgung von COVID-19-Patienten.

BACKGROUND: The COVID-19 pandemic challenges hospital clinicians by additional burdens. Key questions are whether hospital clinicians have experienced more stress in the care of COVID-19 patients and whether patient safety and quality of care have changed. METHODS: Cross-sectional study using an online survey with clinicians in German hospitals on working conditions and quality of care during the COVID-19 pandemic, comparing clinicians with (MmK) vs. without direct contact (MoK) to COVID-19 patients. RESULTS: In total, 2122 clinicians participated. Most clinicians were physicians (15.4%, n = 301) or nurses (77.0%, n = 1505) working in major acute care hospitals (46.0%, n = 899). Every second respondent stated that they worked more than usual (46.4%, n = 907) and took on additional activities (47.7%, n = 932). A quarter of the participants did not receive any training or get instructions in devices (21.5%, n = 421). Only 51.5% (n = 1006) of the respondents were provided with sufficient personal protective equipment. More than 30% (32.7%, n = 639) were more satisfied than usual. The comparing clinicans with vs. without direkt contact to Covid-19 patients worked more shifts than usual (> 2 shifts: 24.1%, n = 306 vs. 13.7%, n = 63, p < 0.001) and without instruction (27.9%, n = 364 vs. 17.1%), n = 57, p < 0.001). In terms of patient safety, there were more deficiencies in the care, mechanical ventilation and nursing (all p < 0.001). CONCLUSION: The cross-sectional study indicates an increased burden on clinicians and a restricted quality of care for patients with COVID-19. A risk to patients or clinicians cannot be excluded.

Application of a TNF-alpha-inhibitor into the scala tympany after cochlear electrode insertion trauma in guinea pigs: preliminary audiologic results.

OBJECTIVE: Cochlear implantation trauma causes both macroscopic and inflammatory trauma. The aim of the present study was to evaluate the effectiveness of the TNF-alpha inhibitor etanercept applied after cochlear implantation trauma on the preservation of acoustic hearing. DESIGN: Guinea pigs were randomly assigned to three groups receiving cochlear implantation trauma by cochleostomy. In one group, the site was sealed by bone cement with no further treatment. A second group was additionally implanted with an osmotic minipump delivering artificial perilymph into the scala tympani for seven days. In the third group, etanercept 1 mg/ml was added to artificial perilymph. Hearing was assessed by auditory brainstem responses at 2, 4, 6, and 8 kHz prior to and after surgery and on days 3, 5, 7, 14, 28. STUDY SAMPLE: Fifteen healthy guinea pigs. RESULTS: The trauma led to threshold shifts from 50.3 dB ± 16.3 dB to 68.0 dB ± 19.3 dB. Hearing thresholds were significantly lower in etanercept-treated animals compared to controls on day 28 at 8 kHz and from day 3 onwards at 4 and 2 kHz (p < 0.01; two-way RM ANOVA / Bonferroni t-test). CONCLUSION: The application of etanercept led to preservation of acoustic hearing after cochlear implantation trauma.

[Position paper on working in the intensive care unit during pregnancy : DIVI recommendations for improving the situation of pregnant employees in the ICU]. / Positionspapier zum Arbeiten in der Schwangerschaft auf der Intensivstation : DIVI-Empfehlungen zur Verbesserung der Lage von schwangeren Mitarbeiterinnen auf einer Intensivstation.

The Maternity Protection Act is intended to protect the mother and the child from hazards, excessive demands and damage to health in the workplace, and from financial disadvantages and loss of employment. However, the objectives defined by the Maternity Protection Act-the safety and health of the pregnant employee on the one hand and the prevention of disadvantages in working life on the other-are not yet adequately achieved in the intensive care unit (ICU). Implementation of the Maternity Protection Act to the benefit of all involved parties should also be promoted in the specialist areas represented by the DIVI, in particular the work of pregnant physicians and nursing staff and other working specialists (respiratory therapists, physiotherapists, speech therapists, psychotherapists, and social workers) in the ICU. The aim of this paper is to raise awareness of the need to consider each pregnant and breastfeeding staff member individually and to work together to find a personal solution for continuing to work in the ICU. Possible ways and solutions to achieve this goal are outlined and practical examples are given for implementation in everyday clinical routine. These are also based on comprehensive presentation of activities according to a traffic light color-code system for all occupational groups. Arguments against pregnant employees working in the ICU are discussed and possible solutions are presented.

[Position paper on working in the intensive care unit during pregnancy : DIVI recommendations for improving the situation of pregnant employees in the ICU]. / Positionspapier zum Arbeiten in der Schwangerschaft auf der Intensivstation : DIVI-Empfehlungen zur Verbesserung der Lage von schwangeren Mitarbeiterinnen auf einer Intensivstation.

The Maternity Protection Act is intended to protect the mother and the child from hazards, excessive demands and damage to health in the workplace, and from financial disadvantages and loss of employment. However, the objectives defined by the Maternity Protection Act-the safety and health of the pregnant employee on the one hand and the prevention of disadvantages in working life on the other-are not yet adequately achieved in the intensive care unit (ICU). Implementation of the Maternity Protection Act to the benefit of all involved parties should also be promoted in the specialist areas represented by the DIVI, in particular the work of pregnant physicians and nursing staff and other working specialists (respiratory therapists, physiotherapists, speech therapists, psychotherapists, and social workers) in the ICU. The aim of this paper is to raise awareness of the need to consider each pregnant and breastfeeding staff member individually and to work together to find a personal solution for continuing to work in the ICU. Possible ways and solutions to achieve this goal are outlined and practical examples are given for implementation in everyday clinical routine. These are also based on comprehensive presentation of activities according to a traffic light color-code system for all occupational groups. Arguments against pregnant employees working in the ICU are discussed and possible solutions are presented.

Safety and immunogenicity of the live-attenuated hRVFV-4s vaccine against Rift Valley fever in healthy adults: a dose-escalation, placebo-controlled, first-in-human, phase 1 randomised clinical trial.

BACKGROUND: Rift Valley fever virus, a pathogen to ruminants, camelids, and humans, is an emerging mosquito-borne bunyavirus currently endemic to Africa and the Arabian Peninsula. Although animals are primarily infected via mosquito bites, humans mainly become infected following contact with infected tissues or fluids of infected animals. There is an urgent need for adequate countermeasures, especially for humans, because effective therapeutics or vaccines are not yet available. Here we assessed the safety, tolerability, and immunogenicity of a next-generation, four-segmented, live-attenuated vaccine candidate, referred to as hRVFV-4s, in humans. METHODS: A first-in-human, single-centre, randomised, double-blind, placebo-controlled trial was done in Belgium in which a single dose of hRVFV-4s was administered to healthy volunteers aged 18-45 years. Participants were randomly assigned using an interactive web response system. The study population encompassed 75 participants naive to Rift Valley fever virus infection, divided over three dosage groups (cohorts) of 25 participants each. All participants were followed up until 6 months. Using a staggered dose escalating approach, 20 individuals of each cohort were injected in the deltoid muscle of the non-dominant arm with either 104 (low dose), 105 (medium dose), or 106 (high dose) of 50% tissue culture infectious dose of hRVFV-4s as based on animal data, and five individuals per cohort received formulation buffer as a placebo. Primary outcome measures in the intention-to-treat population were adverse events and tolerability. Secondary outcome measures were vaccine-induced viraemia, vaccine virus shedding, Rift Valley fever virus nucleocapsid antibody responses (with ELISA), and neutralising antibody titres. Furthermore, exploratory objectives included the assessment of cellular immune responses by ELISpot. The trial was registered with the EU Clinical Trials Register, 2022-501460-17-00. FINDINGS: Between August and December, 2022, all 75 participants were vaccinated. No serious adverse events or vaccine-related severe adverse events were reported. Pain at the injection site (51 [85%] of 60 participants) was most frequently reported as solicited local adverse event, and headache (28 [47%] of 60) and fatigue (28 [47%] of 60) as solicited systemic adverse events in the active group. No vaccine virus RNA was detected in any of the blood, saliva, urine, or semen samples. Rift Valley fever virus nucleocapsid antibody responses were detected in most participants who were vaccinated with hRVFV-4s (43 [72%] of 60 on day 14) irrespective of the administered dose. In contrast, a clear dose-response relationship was observed for neutralising antibodies on day 28 with four (20%) of 20 participants responding in the low-dose group, 13 (65%) of 20 responding in the medium-dose group, and all participants (20 [100%] of 20) responding in the high-dose group. Consistent with the antibody responses, cellular immune responses against the nucleocapsid protein were detected in all dose groups, whereas a more dose-dependent response was observed for the Gn and Gc surface glycoproteins. Neutralising antibody titres declined over time, whereas nucleocapsid antibody responses remained relatively stable for at least 6 months. INTERPRETATION: The hRVFV-4s vaccine showed a high safety profile and excellent tolerability across all tested dose regimens, eliciting robust immune responses, particularly with the high-dose administration. The findings strongly support further clinical development of this candidate vaccine for human use. FUNDING: The Coalition for Epidemic Preparedness Innovations with support from the EU Horizon 2020 programme.

[Children visiting intensive care units and emergency departments : Kids are welcome!] / Besuche von minderjährigen Angehörigen in der Intensiv- und Notfallmedizin : Kinder als Besucher willkommen!

In this white paper, key recommendations for visitation by children in intensive care units (ICU; both pediatric and adult), intermediate care units and emergency departments (ED) are presented. In ICUs and EDs in German-speaking countries, the visiting policies for children and adolescents are regulated very heterogeneously: sometimes they are allowed to visit patients without restrictions in age and time duration, sometimes this is only possible from the age of teenager on, and only for a short duration. A request from children to visit often triggers different, sometimes restrictive reactions among the staff. Management is encouraged to reflect on this attitude together with their employees and to develop a culture of family-centered care. Despite limited evidence, there are more advantages for than against a visit, also in hygienic, psychosocial, ethical, religious, and cultural aspects. No general recommendation can be made for or against visits. The decisions for a visit are complex and require careful consideration.

Quality indicators in intensive care medicine for Germany - fourth edition 2022.

The measurement of quality indicators supports quality improvement initiatives. The German Interdisciplinary Society of Intensive Care Medicine (DIVI) has published quality indicators for intensive care medicine for the fourth time now. After a scheduled evaluation after three years, changes in several indicators were made. Other indicators were not changed or only minimally. The focus remained strongly on relevant treatment processes like management of analgesia and sedation, mechanical ventilation and weaning, and infections in the ICU. Another focus was communication inside the ICU. The number of 10 indicators remained the same. The development method was more structured and transparency was increased by adding new features like evidence levels or author contribution and potential conflicts of interest. These quality indicators should be used in the peer review in intensive care, a method endorsed by the DIVI. Other forms of measurement and evaluation are also reasonable, for example in quality management. This fourth edition of the quality indicators will be updated in the future to reflect the recently published recommendations on the structure of intensive care units by the DIVI.