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Patient-reported outcomes are an important tool in clinical research. In the setting of cancer treatments, benefit of therapy is essentially characterised by improvement of survival as well as quality of life ( QoL). A standardised instrument to assess QoL is the standardised QoL questionnaire of the European Organisation for Research and Treatment ( EORTC QLQ- C30 questionnaire). QoL instruments provide data on different aspects (domains) of the framework of QoL. Using these questionnaires in studies provides data on how a treatment affects QoL in a group of patients. The goal of our concept is to individualise QoL and to use validated instruments in order to integrate patients' perspectives and aims into treatment assessment, planning and control. We propose to use the domains of the EORTC QLQ- C30 and to ask the patient to determine which objectives besides survival are relevant for him and should be achieved by treatment. These individual goals can be used in a process of shared decision-making to choose and monitor treatment. In clinical studies, this approach would allow to recruit more patients who would most probably benefit from the therapy. In addition, supportive data could be gathered in correlation to treatment goals and actual benefits. [ABSTRACT FROM AUTHOR]

Objectives: To evaluate the feasibility and effectiveness of the SHARE TO CARE (S2C) programme, a complex intervention designed for hospital-wide implementation of shared decision-making (SDM)., Design: Pre-post study., Setting: University Hospital Schleswig-Holstein (UKSH), Kiel Campus., Participants: Healthcare professionals as well as inpatients and outpatients from 22 departments of the Kiel Campus of UKSH., Interventions: The S2C programme is a comprehensive implementation strategy including four core modules: (1) physician training, (2) SDM support training for and support by nurses as decision coaches, (3) patient activation and (4) evidence-based patient decision aid development and integration into patient pathways. After full implementation, departments received the S2C certificate., Main Outcome Measures: In this paper, we report on the feasibility and effectiveness outcomes of the implementation. Feasibility was judged by the degree of implementation of the four modules of the programme. Outcome measures for effectiveness are patient-reported experience measures (PREMs). The primary outcome measure for effectiveness is the Patient Decision Making subscale of the Perceived Involvement in Care Scale (PICS PDM ). Pre-post comparisons were done using t-tests., Results: The implementation of the four components of the S2C programme was able to be completed in 18 of the 22 included departments within the time frame of the study. After completion of implementation, PICS PDM showed a statistically significant difference (p<0.01) between the means compared with baseline. This difference corresponds to a small to medium yet clinically meaningful positive effect (Hedges' g=0.2). Consistent with this, the secondary PREMs (Preparation for Decision Making and collaboRATE) also showed statistically significant, clinically meaningful positive effects., Conclusions: The hospital-wide implementation of SDM with the S2C-programme proved to be feasible and effective within the time frame of the project. The German Federal Joint Committee has recommended to make the Kiel model of SDM a national standard of care., Competing Interests: Competing interests: All authors received funding from the German Innovations Fund; FS, FG and JUR are co-founders of the SHARE TO CARE Patientenzentrierte Versorgung; KW received honoraria for being member of an advisory board for BMS on SDM; MC received consultancy fees from University Hospital Schleswig-Holstein LS is consultant for the Federal Ministry of Health (Germany), Federal Insurance Office and 4 statutory health insurance companies., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: According to the legal definition healthcare systems and their components (e.g., hospitals) are part of the critical infrastructure of modern industrial nations. During the last few years hospitals increasingly became targets of cyber attacks causing severe impairment of their operability for weeks or even months. According to the German federal strategy for protection of critical infrastructures (KRITIS strategy), hospitals are obligated to take precautions against potential cyber attacks or other IT incidents. Objective: This article describes the process of planning, execution and results of an advanced table-top exercise which took place in a university hospital in Germany and simulated the first 3 days after a cyber attack causing a total failure of highly critical IT systems. Material and methods: During a first stage lasting about 8 months IT-dependent processes within the clinical routine were identified and analyzed. Then paper-based and off-line back-up processes and workarounds were developed and department-specific emergency plans were defined. Finally, selected central facilities such as pharmacy, laboratory, radiology, IT and the hospitals crisis management team took part in the actual disaster exercise. Afterwards the participants were asked to evaluate the exercise and the hospitals cyber security using a questionnaire. On this basis the authors visualized the hospitalʼs resilience against cyber incidents and defined short-term, medium-term and long-term needs for action. Results: Of the participants 85% assessed the exercise as beneficial, 97% indicated that they received adequate support during the preparations and 75% had received sufficient information; however, only 34% had the opinion that the hospitalʼs and their own preparedness against critical IT failures were sufficient. Before the exercise took place, IT-specific emergency plans were present only in 1.7% of the hospital facilities but after the exercise in 86.7% of the clinical and technical departments. The highest resilience against cyber attacks was not surprisingly reported by facilities that still work routinely with paper-based or off-line processes, the IT department showed the lowest resilience as it would come to a complete shutdown in cases of a total IT failure. Conclusion: The authors concluded that the planning phase is the most important stage of developing the whole exercise, giving the best opportunity for working out fallback levels and workarounds and through this strengthen the hospitals resilience against cyber attacks and comparable incidents. A meticulous preparedness can minimize the severe effects a total IT failure can cause on patient care, staff and the hospital as a whole. [ABSTRACT FROM AUTHOR]

Background: To assess quality of life and unmet needs after stroke, patient-reported outcome measures (PROMs) have gained increasing attention. However, patients' perspectives on assessing PROMs remain unclear, potentially hindering implementation into clinical practice. Therefore, this study explored patients' preferences on assessing PROMs after ischemic stroke. Methods: A paper-based questionnaire was sent to stroke survivors treated at the Department of Neurology, University of Leipzig, Germany. Health-related quality of life (HRQoL, EQ-5D-5L) and preferences regarding different aspects of data collection to assess PROMs were investigated and linked to socio-demographic and medical characteristics. Results: 158 persons were contacted and 80 replies were subsequently analyzed. Mean age was 70.16 years and mean HRQoL was 68.79 (visual analogue scale with a theoretical maximum of 100). Participants showed positive attitudes towards PROMs as they saw potential to improve care of other patients (n = 66/79; 83.54%) or to improve their own situation (n = 53/74; 71.62%). Participants preferred an annual interview after stroke (n = 39/80; 48.75%) and would preferably spend 15–30 min (n = 41/79; 51.90%) to answer a written survey (n = 69/80; 86.25%). The initially treating clinic was preferred as initiator of such surveys (n = 43/79; 54.43%). Stratification revealed that participants with more than 1 h of daily digital media usage preferred email as way of communication. Conclusions: For the first time, this study showed individual preferences on assessing PROMs after ischemic stroke, focusing on the way, time interval, duration, and initiation site of surveys. These insights might help to successfully implement PROMs after stroke and subsequently detect unmet needs and deficits in stroke care. [ABSTRACT FROM AUTHOR]

College students have been recognized as a risk group for substance use. Nevertheless, coherent risk factors for stimulant use remain to be elucidated. The objective of this paper is to identify risk factors associated with the recreational use of MDMA, cocaine, amphetamine and methamphetamine. An online questionnaire was distributed among colleges in Berlin. A sample of 12,914 college students participated, of which 9,382 met the inclusion criteria. Past-month prevalence was 7.0% for MDMA, 6.7% for amphetamine, 5.8% for cocaine and 0.1% for methamphetamine. Associated factors included male gender, "other" gender, homosexual and bisexual orientation, open relationship status or being single, engaging in sexual risk-taking behavior, having a psychiatric diagnosis, tobacco use, drinking alcohol and an increased number of (illicit) substances consumed in the past month and in life. Berlin college students showed a substantially higher prevalence of stimulant use compared to both the general population and college students in other cities. Certain parameters, e.g., polydrug use, were particularly high in this group. The results can be used in further development of prevention efforts. However, conclusions about causality are limited by the cross-sectional nature of this study, highlighting the necessity for longitudinal studies in this field. [ABSTRACT FROM AUTHOR]

Aim: To describe activities and professional characteristics of nurses in expanded roles in acute care in Germany and achieve a greater understanding of the current situation of advanced practice nursing. Background: Advanced practice nursing plays an important role in meeting increased demands in healthcare and promoting high‐quality care. Introduction: In Germany, advanced practice nursing is still at an early stage with a lack of studies describing the scope of practice of nurses in expanded roles. Methods: We conducted a cross‐sectional‐study using a paper‐and‐pencil questionnaire. In a nationwide convenience sample, we surveyed nurses with an academic degree, who work in an acute care hospital and take over expanded roles in direct patient care. Reporting followed the STROBE checklist. Results: Of 108 eligible nurses, 84 (77%) completed the survey. The majority had a Master's degree (63.1%) and the average work experience was 18.2 years. Participants carried out activities in all the domains that were queried (direct clinical practice, guidance and coaching, consultation, leadership and research) with differences within and between domains. Foci were on direct clinical practice and coaching and guidance. Discussion: In Germany, qualifications are nearing the international standard of advanced practice nursing. Results suggest that participants partly undertake activities within the scope of registered nurses' practice that do not correspond fully to their formal qualifications. Conclusion and implications for nursing and/or health policy: In order to foster the role development of expanded practice nurses in Germany, political efforts are needed in terms of training (e.g. specific Master's programmes), funding of corresponding positions in practice and control mechanisms (e.g. professional registration). [ABSTRACT FROM AUTHOR]

Risk assessment in operative medicine is a key aspect for patient safety. The aim of this paper is to outline the degree of dissemination of a standardized procedure for risk analysis, process-oriented risk analysis, at German university hospitals. Process-oriented risk analysis represents a standardized procedure for the analysis of adverse events within the framework of clinical risk management. In this study, 262 full professors of German university hospitals were surveyed in November 2020 regarding the use of this instrument. The response rate was 17%. The analysis showed that 29% of the respondents already introduced the process-oriented risk analysis in their department. Further, 97% of the respondents were willing to standardize clinical processes with regard to patient safety. Moreover, 95% of the respondents said that a risk analysis and the resulting implementation of new procedural measures were important. It could be shown that the readiness for the procedural consideration of clinical processes with regard to patient safety is 92%. Currently, there is a lack of scientific evidence on the effectiveness and efficiency of the process-oriented risk analysis which is why further studies are needed to achieve a comprehensive understanding of this tool. [ABSTRACT FROM AUTHOR]

Background: Research has shown that routinely assessed, patient-reported outcome measures (PROMs) have positive effects in patients with advanced oncologic diseases. However, the transferability of these results to specialist palliative care is uncertain because patients are more impaired and staff doubt the feasibility and benefits. The aim of this study is to evaluate the feasibility of patient self-assessment of PROMs, their use by staff and the benefits in palliative care wards. Method: A multicentre observational study was conducted in the context of the implementation of the Integrated Patient Outcome Scale (IPOS) in three specialist palliative care wards at university hospitals in Germany. All admitted patients who screened positive regarding their ability to complete questionnaires were asked to participate and complete the IPOS on paper weekly, with assistance if necessary. Feasibility of questionnaire completion (e.g. proportion of patients able to complete them), use (e.g. involvement of different professional groups) and benefit (e.g. unexpected information in IPOS as rated by treating physicians) were assessed. Staff members' opinion was obtained in a written, anonymous evaluation survey, patients' opinion in a short written evaluation. Results: A total of 557 patients were screened for eligibility, 235 were assessed as able to complete the IPOS (42.2%) and 137 participated in the study (24.6%). A majority needed support in completing the IPOS; 40 staff members and 73 patients completed the evaluation. Unexpected information was marked by physicians in 95 of the 137 patient questionnaires (69.3%). The staff differed in their opinions on the question of whether this also improved treatment. A majority of 32 staff members (80.0%) were in favour of continuing the use of IPOS (4 against continuation, 4 no answer); 43 (58.9%) patients rated their overall experience of IPOS use as 'positive', 29 (39.7%) as 'neutral' and 1 (1.4%) as 'negative'. Conclusions: While most staff wished to continue using IPOS, it was a challenge to integrate the effort to support the completion of IPOS into daily practice. Digital implementation was not successful, despite various attempts. To explore the effects on care and patient outcomes, multicentre cluster-randomised trials could be employed. Trial registration: German Clinical Trials Register DRKS-ID: DRKS00016681 (24/04/2019). [ABSTRACT FROM AUTHOR]

The administrative burden for physicians in the hospital can affect the quality of patient care. The Service Center Medical Informatics (SMI) of the University Hospital Würzburg developed and implemented the smartphone-based mobile application (MA) ukw.mobile1 that uses speech recognition for the point-of-care ordering of radiological examinations. The aim of this study was to examine the usability of the MA workflow for the point-of-care ordering of radiological examinations. All physicians at the Department of Trauma and Plastic Surgery at the University Hospital Würzburg, Germany, were asked to participate in a survey including the short version of the User Experience Questionnaire (UEQ-S) and the Unified Theory of Acceptance and Use of Technology (UTAUT). For the analysis of the different domains of user experience (overall attractiveness, pragmatic quality and hedonic quality), we used a two-sided dependent sample t-test. For the determinants of the acceptance model, we employed regression analysis. Twenty-one of 30 physicians (mean age 34 ± 8 years, 62% male) completed the questionnaire. Compared to the conventional desktop application (DA) workflow, the new MA workflow showed superior overall attractiveness (mean difference 2.15 ± 1.33), pragmatic quality (mean difference 1.90 ± 1.16), and hedonic quality (mean difference 2.41 ± 1.62; all p <.001). The user acceptance measured by the UTAUT (mean 4.49 ± 0.41; min. 1, max. 5) was also high. Performance expectancy (beta = 0.57, p =.02) and effort expectancy (beta = 0.36, p =.04) were identified as predictors of acceptance, the full predictive model explained 65.4% of its variance. Point-of-care mHealth solutions using innovative technology such as speech-recognition seem to address the users' needs and to offer higher usability in comparison to conventional technology. Implementation of user-centered mHealth innovations might therefore help to facilitate physicians' daily work. [ABSTRACT FROM AUTHOR]

Background: The results of recent surveys indicate that more than 50% of the German population has experience with complementary and alternative medicine (CAM) or uses CAM regularly. This study investigated the CAM usage and CAM-related needs of hospitalized patients at university medical centres in the state of Baden-Württemberg, Germany., Methods: A multi-centre, paper-based, pseudonymous survey was carried out by the members of the Academic Centre for Complementary and Integrative Medicine. Patients of all ages, regardless of sex, diagnosis and treatment, who were hospitalized in the Department of Cardiology, Gastroenterology, Oncology, Gynaecology or Surgery at the university medical centres in Freiburg, Heidelberg, Tübingen and Ulm were eligible for inclusion., Results: Of the 1275 eligible patients, 67% (n = 854) consented to participate in the survey. Forty-eight percent of the study participants stated that they were currently using CAM. The most frequently used therapies were exercise (63%), herbal medicine (54%) and dietary supplements (53%). Only 16% of the patients discussed CAM usage with their attending physician. Half of the patients (48%) were interested in CAM consultations. More than 80% of the patients desired reliable CAM information and stated that physicians should be better informed about CAM., Conclusions: The frequency of CAM usage and the need for CAM counselling among hospitalized patients at university medical centres in Baden-Württemberg are high. To better meet patients' needs, CAM research and physician education should be intensified., Trial Registration: German Clinical Trial register ( DRKS00015445 )., (© 2021. The Author(s).)

Background: Nazi Germany surrendered to the Allies on May 8, 1945. Six months later, the Allies tried the surviving leaders of Nazi Germany at the first Nuremberg trial. Later, the United States conducted 12 additional trials. The first one, The Unites States of America versus Karl Brandt et al., has been dubbed the Doctors' Trial. During the trial, the prosecution relied on the testimony of Dr. Andrew Ivy and Dr. Leo Alexander. At the end of the trial, Judge Sebring enunciated 10 principles needed to conduct human subject research-the Nuremberg Code. Authorship of the Code has been the subject of dispute, with both Ivy and Alexander claiming sole authorship.Methods: In the summer of 2017, I visited Duke University Medical Center's Archives and surveyed the contents of boxes labeled "Alexander's papers." I also explored online databases with information on the Doctors' Trial. Pertinent documents were compared across collections, and against scholarly works on the topic.Results: Box 3 of Alexander's papers at Duke University Medical Center's Archives contains a three-page document with six principles that, nearly word for word, were included in what is known as the Nuremberg Code. Alexander's name and appointment are typed at the end of the document.Conclusions: Although the Nuremberg Code is likely to have been an unplanned collaboration among members of the prosecuting team and the judges, I present evidence suggesting that Alexander drafted the blueprint and was the main contributor to the final version of the Code. [ABSTRACT FROM AUTHOR]

Focused question What is the effect of mechanical inter-dental plaque removal in addition to toothbrushing, on managing gingivitis using various formats of inter-dental self-care in adults based on evidence gathered from existing systematic reviews? Material & Methods Three Internet sources were searched by a strategy designed to include systematic reviews on inter-dental cleaning devices. Plaque and gingivitis scores were the primary parameters of interest. Characteristics of selected papers were extracted. The potential risk of bias was estimated and the acquired evidence was graded. Results Screening of 395 papers resulted in six systematic reviews. Two papers evaluated the efficacy of dental floss, two of inter-dental brushes ( IDB), one of woodsticks and one of the oral irrigator. Weak evidence of unclear or small magnitude was retrieved that supported dental floss, woodsticks and the oral irrigator to reduce gingivitis in addition to toothbrushing. No concomitant evidence for an effect on plaque emerged. There is moderate evidence that IDBs in combination with toothbrushing reduce both plaque and gingivitis. Conclusion Evidence suggests that inter-dental cleaning with IDBs is the most effective method for inter-dental plaque removal. The majority of available studies fail to demonstrate that flossing is generally effective in plaque removal. All investigated devices for inter-dental self-care seem to support the management of gingivitis, however, to a varying extend. [ABSTRACT FROM AUTHOR]

The reproducibility crisis triggered worldwide initiatives to improve rigor, reproducibility, and transparency in biomedical research. There are many examples of scientists, journals, and funding agencies adopting responsible research practices. The QUEST (Quality-Ethics-Open Science-Translation) Center offers a unique opportunity to examine the role of institutions. The Berlin Institute of Health founded QUEST to increase the likelihood that research conducted at this large academic medical center would be trustworthy, useful for scientists and society, and ethical. QUEST researchers perform "science of science" studies to understand problems with standard practices and develop targeted solutions. The staff work with institutional leadership and local scientists to incentivize and support responsible practices in research, funding, and hiring. Some activities described in this paper focus on the institution, whereas others may benefit the national and international scientific community. Our experience, approaches, and recommendations will be informative for faculty leadership, administrators, and researchers interested in improving scientific practice., Competing Interests: The authors have declared that no competing interests exist.

Context: The LMU University Hospital is among the largest healthcare facilities in Germany. The measures implemented prior to and during the first pandemic wave of COVID-19, were evaluated in preparation of a second pandemic wave. This paper presents the pandemic management concept, evaluation and adaptation of LMU University Hospital. Methods: Between July and September 2020 the disaster management team of LMU University Hospital conducted a mixed-method evaluation of the hospital's pandemic management. A workshop series based on the After Action Review working group format was organized to examine the management structure, decision-making processes, documentation, and crisis preparedness response for a second COVID-19 wave. Further, the satisfaction of employees with the hospital's COVID-19 management was examined through an anonymous survey. Results: The workshop series highlighted a need for structural and operational adaptation of the COVID-19 management at LMU University Hospital. The results of the employee survey (N = 2182) provided positive feedback for the measures taken during the first pandemic wave. Specific actions were derived concerning the availability of personal protective equipment and emergency childcare services. A key outcome of both evaluation activities was the identified need for further improvement in communication between stakeholders. All changes were adopted prior to the second pandemic wave. [ABSTRACT FROM AUTHOR]

Aim: Health care–associated infections along with antibiotic resistance are a leading risk for patient safety in intensive care units. Hygienic hand disinfection is still regarded as the most effective, simplest, and most cost‐effective measure to reduce health care–associated infections. To improve hand hygiene compliance and to prevent health care–associated infections, interventions of the "German Clean Hands Campaign" were implemented in a university hospital. Methods: Observational single‐center study using direct observation and feedback. Hand hygiene performance was assessed in 12 intensive care units between 2013 and 2017. Linear mixed model regression analyses were used to estimate the compliance trend over time. Results: In total, 10 315 "my five moments for hand hygiene" were observed. The mean hand hygiene compliance rates increased from 75.1% to 88.6% during the study period, yielding an estimated increase of about 4.5% per year. However, there are differences in compliance between occupational groups (physicians: between 61.2% and 77.1%; nurses: between 80.2% and 90.9%; others: between 61.3% and 82.4%). Conclusions: After implementation of the "German Clean Hands Campaign" interventions, an overall significant improvement of hand hygiene was detected. Compliance measurements helped to raise awareness among health care professional groups. SUMMARY STATEMENT: What is already known about this topic? A significantly higher prevalence of infections has been observed in intensive care unit patients compared with patients in other wards.Hygienic hand disinfection is still regarded as the most effective, simplest, and most cost‐effective measure to reduce health care–associated infections.Low hand hygiene rates in intensive care units are a major problem for patient safety. What is already known about this topic? Implementation of the "German Clean Hands Campaign" showed continuous improvement in hand hygiene for all health care professionals in intensive care units over a period of 5 years.There are differences in compliance rates between health care profession and intensive care unit types.Pediatric intensive care units had the highest hand hygiene compliance rates. The implications of this paper: Overall, hand hygiene compliance in intensive care units increased over a period of 5 years after continuous campaigning, training, observation, compliance measurements, and direct feedback.It is necessary to raise awareness for hand hygiene in a repetitive manner within all health care professional groups now and in the future.Because of the differences in compliance rates between health care professionals, more tailored and evidence‐based interventions should be implemented. [ABSTRACT FROM AUTHOR]

Background: Checklists are a common tool used in order to mitigate risks caused by human factors and can facilitate the safe induction of anesthesia as well as handovers. SBAR (Situation, Background, Assessment, Recommendation) is a checklist recommended by the WHO and DGAI for handovers, while SOAP-M (Suction, Oxygen, Airway, Pharmaceuticals, Monitoring) is a checklist for the induction of anesthesia. This study investigates the implementation and adoption of these two checklists. Methods: We conducted a single-center online survey one year after the implementation of SOAP-M and SBAR at a university hospital's anesthesiology department, using scales from three validated questionnaires to assess safety attitudes as well as the behavior of staff and the perceived usefulness of the checklists. Results: Staff with a high score in general attitude towards patient safety, as determined by the safety attitudes questionnaire, considered both checklists useful additions to their work environment. Nurses and physicians (p = 0.102) as well as groups divided according to work experience (p = 0.077) showed no significant differences in using SOAP-M and SBAR. Perceived usefulness was significantly higher (p < 0.001) among users of the checklists, and the same goes for positive reinforcement (p < 0.001), social cues (p = 0.0215) and goal cues (p = 0.0252). Conclusion: SOAP-M and SBAR are perceived as useful checklists for patient handovers and anesthesia induction by tertiary referral hospital's employees with high score in general safety attitude and were therefore commonly used one year after their introduction. No significant difference in checklist adoption between occupations as well as groups divided according to work experience could be found. Perceived usefulness is significantly higher among users of the checklist, who feel using the checklists provides more support. [ABSTRACT FROM AUTHOR]

Simple Summary: Sacrectomy represents a radical indication for bone sarcomas (e.g., osteosarcoma or chondrosarcoma) and chordomas, as well as selected carcinomas with invasion of the sacrum. Extralesional en bloc excision is surgically demanding and associated with resection-induced neurologic deficits and risks. Due to the low incidence of bone sarcomas, the rare localization in the sacrum and the complexity of the surgical procedure, studies reporting on the oncological outcome and corresponding complications in larger patient numbers are rare. The aim was to describe the oncosurgical management and the complication profile and to analyze our own treatment results after partial/total sacrectomy, with attention paid to a possible benefit by using intraoperative 3D navigation. There was a significant difference in progression-free and metastasis-free survival between sarcoma, chordoma and carcinoma patients. Complications were common, but no independently influencing causative factors could be identified. Although there was a subjective impression of improved intraoperative 3D orientation and easier identification of resection planes, the use of navigation did not significantly influence resection status or oncological patient outcome. Introduction: Bone sarcoma or direct pelvic carcinoma invasion of the sacrum represent indications for partial or total sacrectomy. The aim was to describe the oncosurgical management and complication profile and to analyze our own outcome results following sacrectomy. Methods: In a retrospective analysis, 27 patients (n = 8/10/9 sarcoma/chordoma/locally recurrent rectal cancer (LRRC)) were included. There was total sacrectomy in 9 (incl. combined L5 en bloc spondylectomy in 2), partial in 10 and hemisacrectomy in 8 patients. In 12 patients, resection was navigation-assisted. For reconstruction, an omentoplasty, VRAM-flap or spinopelvic fixation was performed in 20, 10 and 13 patients, respectively. Results: With a median follow-up (FU) of 15 months, the FU rate was 93%. R0-resection was seen in 81.5% (no significant difference using navigation), and 81.5% of patients suffered from one or more minor-to-moderate complications (especially wound-healing disorders/infection). The median overall survival was 70 months. Local recurrence occurred in 20%, while 44% developed metastases and five patients died of disease. Conclusions: Resection of sacral tumors is challenging and associated with a high complication profile. Interdisciplinary cooperation with visceral/vascular and plastic surgery is essential. In chordoma patients, systemic tumor control is favorable compared to LRRC and sarcomas. Navigation offers gain in intraoperative orientation, even if there currently seems to be no oncological benefit. Complete surgical resection offers long-term survival to patients undergoing sacrectomy for a variety of complex diseases. [ABSTRACT FROM AUTHOR]

Simple Summary: In the present study, the intraoperative fluorescence of brain metastases after the administration of 5-aminolevulinic acid (5-ALA) is investigated in 80 cases. Brain metastases fluoresced in 57.5% of cases, with no significant correlation between fluorescence and primary tumor or histological subtype. Complete resection of brain metastases was detected in 82.5%, of which 56.1% were fluorescence positive, compared to 43.9% which were non-fluorescent. Thus, prior administration of 5-ALA tended to improve the resectability rate by 12.1%. Fluorescence-positive and -negative metastases showed significantly different overall survival in this study. Therefore, administration of 5-ALA as a surgical adjuvant may be beneficial in resecting brain metastases and may potentially optimize the surgical procedure. (1) Background: In this study, the intraoperative fluorescence behavior of brain metastases after the administration of 5-aminolevulinic acid (5-ALA) was analyzed. The aim was to investigate whether the resection of brain metastases using 5-ALA fluorescence also leads to a more complete resections and thus to a prolongation of survival; (2) Methods: The following variables have been considered: age, sex, number of metastases, localization, involvement of eloquent area, correlation between fluorescence and primary tumor/subtype, resection, and survival time. The influence on the degree of resection was determined with a control MRI within the first three postoperative days; (3) Results: Brain metastases fluoresced in 57.5% of cases. The highest fluorescence rates of 73.3% were found in breast carcinoma metastases and the histologic subtype adenocarcinoma (68.1%). No correlation between fluorescence behavior and localization, primary tumor, or histological subtype was found. Complete resection was detected in 82.5%, of which 56.1% were fluorescence positive. There was a trend towards improved resectability (increase of 12.1%) and a significantly longer survival time (p = 0.009) in the fluorescence-positive group; (4) Conclusions: 5-ALA-assisted extirpation leads to a more complete resection and longer survival and can therefore represent a low-risk addition to modern surgery for brain metastases. [ABSTRACT FROM AUTHOR]

Simple Summary: This study explored advanced diagnostic methods that are used for identifying skin cancer in high-risk melanoma patients. A total of 410 patients were examined using a combination of three advanced imaging techniques: 3D total body photography, digital dermoscopy, and reflectance confocal microscopy. These methods were used in addition to regular skin exams. Results showed that the specialized imaging detected 16 melanomas in 39 removed pigmented lesions, while regular exams detected only 7 melanomas in 163 removed lesions. This indicates that specialized imaging was much more efficient. Each imaging method found melanomas that the others did not. The study concludes that combining these three imaging techniques improves melanoma detection and reduces unnecessary skin removals in high-risk patients. Modern diagnostic procedures, such as three-dimensional total body photography (3D-TBP), digital dermoscopy (DD), and reflectance confocal microscopy (RCM), can improve melanoma diagnosis, particularly in high-risk patients. This study assessed the benefits of combining these advanced imaging techniques in a three-step programme in managing high-risk patients. This study included 410 high-risk melanoma patients who underwent a specialised imaging consultation in addition to their regular skin examinations in outpatient care. At each visit, the patients underwent a 3D-TBP, a DD for suspicious findings, and an RCM for unclear DD findings. The histological findings of excisions initiated based on imaging consultation and outpatient care were compared. Imaging consultation detected sixteen confirmed melanomas (eight invasive and eight in situ) in 39 excised pigmented lesions. Outpatient care examination detected seven confirmed melanomas (one invasive and six in situ) in 163 excised melanocytic lesions. The number needed to excise (NNE) in the imaging consultation was significantly lower than that in the outpatient care (2.4 vs. 23.3). The NNE was 2.6 for DD and 2.3 for RCM. DD, 3D-TBP, or RCM detected melanomas that were not detected by the other imaging methods. The three-step imaging programme improves melanoma detection and reduces the number of unnecessary excisions in high-risk patients. [ABSTRACT FROM AUTHOR]

Simple Summary: Functional MRI has become established in the surgery of brain metastases (BM) as a preoperative diagnostic tool to identify intact eloquent cortex areas. Evidence shows that by allowing surgeons to spare these intraoperatively, patients' postoperative outcome is improved in terms of significantly reduced mortality and morbidity. The influence specifically of BM on the fMRI signal and brain networks has scarcely been investigated, as most studies to date refer only to primary brain tumors or include various tumor entities. Our work examined how BM affect cortical activation and brain networks using task-based fMRI. We found a qualitative attenuation of patients' fMRI signal in the metastasis-affected hemisphere compared to the contralateral hemisphere and alterations in all examined brain networks of the patients compared to healthy controls, and also in the contralateral hemisphere. Thus, our results provide insights into the behavior of BM during fMRI examination and their impact on the integrity of the brain. To date, there are almost no investigations addressing functional connectivity (FC) in patients with brain metastases (BM). In this retrospective study, we investigate the influence of BM on hemodynamic brain signals derived from functional magnetic resonance imaging (fMRI) and FC. Motor-fMRI data of 29 patients with BM and 29 matched healthy controls were analyzed to assess percent signal changes (PSC) in the ROIs motor cortex, premotor cortex, and supplementary motor cortex and FC in the sensorimotor, default mode, and salience networks using Statistical Parametric Mapping (SPM12) and marsbar and CONN toolboxes. In the PSC analysis, an attenuation of the BOLD signal in the metastases-affected hemisphere compared to the contralateral hemisphere was significant only in the supplementary motor cortex during hand movement. In the FC analysis, we found alterations in patients' FC compared to controls in all examined networks, also in the hemisphere contralateral to the metastasis. This indicates a qualitative attenuation of the BOLD signal in the affected hemisphere and also that FC is altered by the presence of BM, similarly to what is known for primary brain tumors. This transformation is not only visible in the infiltrated hemisphere, but also in the contralateral one, suggesting an influence of BM beyond local damage. [ABSTRACT FROM AUTHOR]

Background: The Homburger Curriculum was introduced in 2012 to enhance the medical resident education and professional satisfaction. At the same time different steps were taken to encourage applications of eligible candidates., Methods: To address candidates, the Homburger Curriculum is presented on the department's website and a short-term hospitation was introduced. The curriculum has been divided into time slots of 4 months throughout the 5 years of residency. In addition, a booklet of documented evidence of the rotations and a Resident's Compendium were introduced. Internal and external teaching programs, additional research projects and involvement of the residents in the organization of their curriculum were introduced. The paper describes the rationale behind the new structure of the curriculum and its practical outcomes for the department (e. g. a regular standby resident to fill in unexpected gaps)., Results: It is discussed in detail which steps were easy to implement and which steps were more difficult to introduce. After consolidation of the numerous steps, the number of resigning residents dropped significantly and the number of applicants increased., Conclusions: The new rotation schedule guarantees every young resident to be able to work at each work area of the Department of Ophthalmology. External training courses can be planned suitable to his/her rotations. An "internal competition" for popular rotations is no longer necessary. Clear organization and transparency in all areas provide good interpersonal climate in which much work still has to be done, but by motivated and satisfied residents.

Objectives The epidemiology of periodontitis regarding oral-hygiene practices particularly the frequency of tooth brushing has been the subject of relatively few dedicated studies. This paper provides a systematic review of available relevant epidemiological studies and a meta-analysis of the effect of tooth brushing frequency on periodontitis. To review and to quantify the risk for periodontitis associated with frequency of tooth brushing. Methods Systematic literature search was conducted in nine online resources ( PUBMED, ISI and 7 additional databases). Related and cross-referencing publications were reviewed. Papers published until end of March 2013 reporting associations between tooth brushing frequency and periodontitis were considered. A meta-analysis was performed to quantify this association. Results Fourteen studies were identified. The test of heterogeneity for cross-sectional studies was not significant ( P = 0.31). A fixed-effects model yielded a significant overall odds ratio estimate of 1.41 (95% CI: 1.25-1.58, P < 0.0001) for infrequent compared to frequent tooth brushing. For all fourteen studies, there was a slight indication for heterogeneity ( I² = 48%, P = 0.02) and the corresponding result with a random-effects model was 1.44 (95% CI: 1.21-1.71, P < 0.0001). Conclusions There are relatively few studies evaluating the association between tooth brushing frequency and periodontitis. A clear effect was observed, indicating that infrequent tooth brushing was associated with severe forms of periodontal disease. Further epidemiological studies are needed to precisely estimate the effect of key risk factors for periodontitis and their interaction effects. [ABSTRACT FROM AUTHOR]

Background: In hemodynamically unstable patients, the passive leg raise (PLR) test is recommended for use as a self-fluid challenge for predicting preload responsiveness. However, to interpret the hemodynamic effects and reliability of the PLR, the method of performing it is of the utmost importance. Our aim was to determine the current practice of the correct application and interpretation of the PLR in intensive care patients. Methods: After ethical approval, we designed a cross-sectional online survey with a short user-friendly online questionnaire. Using a random sample of 1903 hospitals in Germany, 182 hospitals with different levels of care were invited via an email containing a link to the questionnaire. The online survey was conducted between December 2021 and January 2022. All critical care physicians from different medical disciplines were surveyed. We evaluated the correct points of concern for the PLR, including indication, contraindication, choice of initial position, how to interpret and apply the changes in cardiac output, and the limitations of the PLR. Results: A total of 292 respondents participated in the online survey, and 283/292 (97%) of the respondents completed the full survey. In addition, 132/283 (47%) were consultants and 119/283 (42%) worked at a university medical center. The question about the performance of the PLR was answered correctly by 72/283 (25%) of the participants. The limitations of the PLR, such as intra-abdominal hypertension, were correctly selected by 150/283 (53%) of the participants. The correct effect size (increase in stroke volume ≥ 10%) was correctly identified by 217/283 (77%) of the participants. Conclusions: Our results suggest a considerable disparity between the contemporary practice of the correct application and interpretation of the PLR and the practice recommendations from recently published data at German ICUs. [ABSTRACT FROM AUTHOR]

Simple Summary: Colorectal cancer is one of the most commonly diagnosed cancers worldwide with a high probability of developing metastasis over the course of the disease. Only certain patients with colorectal liver metastases can be treated by surgical resection. Different interventional treatments such as laser-induced thermotherapy, microwave ablation, as well as transarterial chemoembolization can be applied for treating colorectal liver metastases. These therapies have been discussed in various studies. However, the current medical literature is still lacking research from large long-term studies. This retrospective monocentric study includes 2140 patients with colorectal liver metastases treated by different locoregional treatments. It is based upon data collected over a period of more than 26 years at the University Hospital Frankfurt of Goethe University. The aim of this study was to analyze the long-term results of different locoregional treatments for colorectal cancer liver metastases (CRLM), including transarterial chemoembolization (TACE), laser-induced thermotherapy (LITT) and microwave ablation (MWA). A total of 2140 patients with CRLM treated at our department between 1993 and 2020 were included in this retrospective study. The patients were divided into the following groups: LITT (573 patients; median age: 62 years), TACE + LITT (346 patients; median age: 62 years), MWA (67 patients; median age: 59 years), TACE + MWA (152 patients; median age: 65 years), and TACE (1002 patients; median age: 62 years). Median survival was 1.9 years in the LITT group and 1.7 years in the TACE + LITT group. The median survival times in the MWA group and TACE + MWA group were 3.1 years and 2.1 years, respectively. The median survival in the TACE group was 0.8 years. The 1-, 3-, and 5-year survival rates were 77%, 27%, and 9% in the LITT group and 74%, 18%, and 5% in the TACE + LITT group, respectively. The corresponding survival rates were 80%, 55%, and 33% in the MWA group, 74%, 36%, and 20% in the TACE + MWA group and 37%, 3%, and 0% in the TACE group, respectively. The long-term results of this study demonstrate the efficacy of locoregional treatments in treating patients with CRLM. The longest survival was found in the MWA group, followed by the combination therapy of TACE and MWA. [ABSTRACT FROM AUTHOR]

Background: The COVID-19 outbreak necessitated physical distancing, as part of secondary prevention, at a personal and professional level. Working from home (WFH) became increasingly important. In this study, the impact of the COVID-19 pandemic restrictions on physical and mental health is investigated, compared with pre-pandemic data, and with employees who WFH and are on-site. Methods: Data from the German Saxon longitudinal study population were used. Attitudes towards WFH as well as mental and physical health assessments during the COVID-19 pandemic were examined. Comparisons were made with corresponding pre-pandemic scores and between employees WFH and on-site in 2022. Results: In total, 319 participants with equal gender distribution were included. Of those, 86 worked from home stating better organizability of their work, more time for partnership, less stress, and greater work satisfaction. Compared to pre-pandemic data, the D-score, PHQ-4, G-Score, and PHQ-SSS-8 showed a significant increase. No difference in physical or mental health between employees WFH and on-site was observed. Conclusion: In general, COVID-19 restrictions had a negative impact on mental and physical health. Although WFH is well accepted, it did not show significant health benefits. [ABSTRACT FROM AUTHOR]

Demographic development and continuing improvements in supportive and antineoplastic therapies are reasonable predictors of increasing travel activities carried out by patients with malignant diseases. There is a lack of data on travel habits of patients with end-stage oncological diseases. We performed a multi-phased cross-sectional study to gain insights into the intersection of travel medicine and oncology. A total of 82 patients with 21 different cancer entities at a median age of 63 years completed the final questionnaire. 90.2% of all participants rated travelling as an important or very important aspect in their lives, of whom 73.2% had participated in a short- or holiday trip after the cancer diagnosis. All but one (98.8%) participant were about to plan a short- or holiday trip in the near future. Germany (home country) was the most important travel destination, 'Relaxing' and 'enjoying nature' were the most important travel motives. Fatigue and overall (medical) insecurities were major obstacles to carry out travel plans. In conclusion, a high proportion of patients enjoy travelling. Physicians and patients are encouraged to openly discuss holiday-taking in accordance with available guidelines. More research is needed to fully understand needs and obstacles at the crossroads of travel medicine and oncology. [ABSTRACT FROM AUTHOR]

Background: Esophagectomy carries a high risk of morbidity and mortality compared to other major surgeries. With the aim of creating an easy-to-use clinical preoperative risk assessment tool and to validate previously described risk factors for major complications following surgery, esophagectomies at two tertiary medical centers were analyzed. Methods: A total of 450 patients who underwent esophagectomy for esophageal carcinoma at the University Medical Centre, Hamburg, or at the Medical Center University Duisburg-Essen, Germany (January 2008 to January 2020) were retrospectively analyzed. Epidemiological and perioperative data were analyzed to identify the risk factors that impact major complication rates. The primary endpoint of this study was to determine the incidence of major complications. Results: The mean age of the patients was 63 years with a bimodal distribution. There was a male predominance across the cohort (81% vs. 19%, respectively). Alcohol abuse (p = 0.0341), chronic obstructive pulmonary disease (p = 0.0264), and cardiac comorbidity (p = 0.0367) were associated with a significantly higher risk of major complications in the multivariate analysis. Neoadjuvant chemotherapy significantly reduced the risk of major postoperative complications (p < 0.0001). Conclusions: Various patient-related risk factors increased the rate of major complications following esophagectomy. Patient-tailored prehabilitation programs before esophagectomy that focus on minimizing these risk factors may lead to better surgical outcomes and should be analyzed in further studies. [ABSTRACT FROM AUTHOR]

Background: To ensure high quality of nurses' communication as part of patient-centered care, training of communication skills is essential. Previous studies indicate that communication skills trainings can improve communication skills of nurses and have a positive effect on emotional and psychological burden. However, most show methodological limitations, are not specifically developed for nurses or were developed for oncological setting only. Methods: This study aims to evaluate the effectiveness of a needs-based communication skills training for nursing professionals and to derive indications for future implementation. A two-armed randomized controlled trial including components from both effectiveness and implementation research will be applied. Additionally, a comprehensive process evaluation will be carried out to derive indications for future implementation. Nurses (n=180) of a university medical center in Germany will be randomized to intervention or waitlist-control group. The intervention was developed based on the wishes and needs of nurses, previously assessed via interviews and focus groups. Outcomes to measure effectiveness were selected based on Kirkpatrick's four levels of training evaluation and will be assessed at baseline, post-training and at 4-weeks follow-up. Primary outcome will be nurses' self-reported self-efficacy regarding communication skills. Secondary outcomes include nurses' communication skills assessed via standardized patient assessment, knowledge about patient-centered communication, mental and work-related burden, and participants' satisfaction with training. Discussion: To our knowledge, this is the first study systematically evaluating the effectiveness of a patient-centered communication skills training for nursing professionals in Germany. Results will yield insight whether a needs-based intervention can improve nurses' self-efficacy regarding communication skills and other secondary outcomes. Trial registration: Clinical trial registration number: NCT05700929, trial register: ClinicalTrials.gov (date of registration: 16 November 2022). [ABSTRACT FROM AUTHOR]

Background: Intensive care units (ICUs) are often too noisy, exceeding 70–80 dBA, which can have negative effects on staff. The corresponding recommendation of the World Health Organization (average sound pressure level below 35 dBA) is often not achieved. To date there is a lack of intervention studies examining the extent to which unit-based noise management in ICUs contributes to a reduction in noise exposure for the staff. The study therefore aims to provide answers to 1) how unit-based noise management sustainably reduces the subjective noise exposure among staff, and 2) how this intervention affects other noise-related topics. Methods: We performed a monocentric prospective longitudinal study with three measurement points in a German university hospital in three ICUs. We collected data from different healthcare professionals and other professional groups between October 2021 and August 2022 using an online questionnaire. Data were analyzed using descriptive and inference statistics. Results: A total of n = 179 participants took part in the surveys. The majority of participants were nurses or pediatric nurses. Most participants worked more than 75% full-time equivalent. Staff on the three ICUs reported high levels of noise exposure. No significant changes in noise exposure over time were observed. Participants were already aware of the topic and believed that a behavior change could positively influence the noise environment. Conclusions: This study provides an initial insight into how a unit-based noise management could contribute to a reduction in the subjective noise exposure among staff in ICUs. The results of this study highlight the importance of this topic. Future studies should aim to research aspects of adherence and their facilitators or barriers, which promote the sustained implementation of noise-reducing measures by staff. Trial registration: German Clinical Trials Register (DRKS): DRKS00025835; Date of registration: 12.08.2021. [ABSTRACT FROM AUTHOR]

Simple Summary: This 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. [ABSTRACT FROM AUTHOR]

Simple Summary: Hyperthermic intrathoracic chemotherapy (HITOC) is an intraoperative treatment after a surgical cytoreduction of pleural malignancies. The pleural cavity is perfused with high doses of cytostatic drugs that are consequentially excreted via various body fluids. These are potential occupational health risk factors for medical staff and safety measurements must be established based on scientific evidence. Hyperthermic intrathoracic chemotherapy (HITOC) is an additional intraoperative treatment option within the multimodality therapy of pleural malignancies. A chemotherapy perfusion with high-dose cisplatin is performed over a period of 60 min after surgical cytoreduction to improve local tumour control through the eradication of residual tumour cells. Although HITOC is increasingly used, there is only little scientific evidence about the necessary safety measures after HITOC. Therefore, the objective of this study was an analysis of cisplatin excretion via various body fluids after HITOC, with the aim of providing recommendations on occupational health and safety. Five patients undergoing HITOC were included. Before and after the HITOC, as well as during the following days, serum, urine, and bronchial secretion, as well as pleural effusion, were sampled. The platinum levels in the samples were measured using ICP-MS (inductively coupled plasma-mass spectrometry). Immediately after the HITOC, the mean levels of cisplatin increased dramatically in the serum (from 0.79 to 1349 µg/L), urine (from 3.48 to 10,528 µg/g creatinine), and bronchial secretion (from 0.11 to 156 µg/L). Thereafter, the cisplatin levels dropped to 133 µg/L in the serum and 994 µg/g creatinine in the urine within nine days after the HITOC. The AUC ratio shows 59% of the cisplatin being excreted via the urine after 48 h. The sampling of pleural effusion started 24 h after the HITOC, and the cisplatin levels decreased from 618 to 93 µg/L within nine days. Although the cisplatin levels in the body fluids of HITOC patients are much lower compared to patients receiving intravenous chemotherapy, a significant amount of cisplatin is excreted via these body fluids. Consequently, safety precautions must be implemented in the post-HITOC care of patients to avoid occupational exposure to cisplatin. [ABSTRACT FROM AUTHOR]

Abstract Background Several recent publications have demonstrated the use of convolutional neural networks to classify images of melanoma at par with board-certified dermatologists. However, the non-availability of a public human benchmark restricts the comparability of the performance of these algorithms and thereby the technical progress in this field. Methods An electronic questionnaire was sent to dermatologists at 12 German university hospitals. Each questionnaire comprised 100 dermoscopic and 100 clinical images (80 nevi images and 20 biopsy-verified melanoma images, each), all open-source. The questionnaire recorded factors such as the years of experience in dermatology, performed skin checks, age, sex and the rank within the university hospital or the status as resident physician. For each image, the dermatologists were asked to provide a management decision (treat/biopsy lesion or reassure the patient). Main outcome measures were sensitivity, specificity and the receiver operating characteristics (ROC). Results Total 157 dermatologists assessed all 100 dermoscopic images with an overall sensitivity of 74.1%, specificity of 60.0% and an ROC of 0.67 (range = 0.538–0.769); 145 dermatologists assessed all 100 clinical images with an overall sensitivity of 89.4%, specificity of 64.4% and an ROC of 0.769 (range = 0.613–0.9). Results between test-sets were significantly different (P < 0.05) confirming the need for a standardised benchmark. Conclusions We present the first public melanoma classification benchmark for both non-dermoscopic and dermoscopic images for comparing artificial intelligence algorithms with diagnostic performance of 145 or 157 dermatologists. Melanoma Classification Benchmark should be considered as a reference standard for white-skinned Western populations in the field of binary algorithmic melanoma classification. Highlights • This paper provides the first open access melanoma classification benchmark for both non-dermoscopic and dermoscopic images. • Algorithms can now be easily compared to the performance of dermatologists in terms of sensitivity, specificity and ROC. • The melanoma benchmark allows comparability between algorithms of different publications and provides a new reference standard. [ABSTRACT FROM AUTHOR]

Background and objective: This paper describes the user acceptance of an anaesthesia information management system at the University Hospital in Giessen, Germany, after 5 yr of routine use. Methods: A questionnaire with 75 items was distributed to all anaesthesiologists and anaesthetic nurses of the Department of Anaesthesiology. The questions were answered anonymously on a five-point Likert scale. Results: The return rate was 60% (44 physicians and 24 nurses). The results indicated that the system generally met user expectations. The respondents thought that electronic record keeping improved the quality of their work, and they did not want to switch back to paper records. Problems arose with hardware placement and software features, e.g. coding tools for diagnoses and type of surgery. The perceived quality of training strongly influenced user acceptance. Conclusions: Despite the deficits revealed by the survey, the respondents did not want to switch back to manual record keeping. A structured user survey is a useful tool for the development, adaptation and implementation of an anaesthesia information management system. A training strategy that takes the needs of the users into account is recommended. [ABSTRACT FROM AUTHOR]

Background: Major demographical changes in Germany commenced in the 1960s. Ongoing humanitarian crises in the Ukraine with subsequent immigration will have also long-range effects on national provision of cancer treatment. Ensuring the best possible outcomes for each cancer patient undergoing radiotherapy requires the prediction and prevention of unfavorable side effects. Given that recent research has primarily focused on clinical outcome indicators solely, less is known regarding sociodemographic predictors of therapeutic outcomes, such as patient nationality. Here, we investigated whether the severity of early side effects after radiotherapy are associated with patient nationality and other sociodemographic and clinical characteristics. Methods: Out of 9187 patients treated at a German university medical center between 2017 and 2021, 178 German and 178 non-German patients were selected for matched-pair analysis based on diagnostic and demographic criteria. For all 356 patients, data on side effects from follow-up care after radiotherapy were collected. Results: Non-German patients were more likely to have severe side effects than German patients. Side effect severity was also associated with tumor entity, concomitant therapy, body mass index, and age. Conclusion: Foreign cancer patients are at higher risk of experiencing severe side effects of radiotherapy, suggesting a need to develop and implement targeted preventive measures for these patients. Further research investigating factors predicting the occurrence of radiotherapy side effects, including other sociodemographic characteristics, is needed to better personalize therapy regimens for cancer. [ABSTRACT FROM AUTHOR]

Colorectal cancer remains one of the most commonly diagnosed cancers. Advanced rectal cancer patients receive neoadjuvant radiochemotherapy as well as surgery and suffer from reduced health-related quality of life due to various side effects. We were interested in the role of the COVID-19 pandemic and how it affected those patients' quality of life. A total of 489 advanced rectal cancer patients from the University Hospital Erlangen in Germany were surveyed between May 2010 and March 2022 and asked to fill out the EORTC QLQ-C30 and QLQ-CR38 questionnaires over eight different time points: at the beginning, during and after radiochemotherapy, right before surgery, and in yearly intervals after surgery for up to four years. Answers were converted to scores to compare the COVID-19 period to the time before March 2020, focusing on the follow-ups, the developments over time—including by sex and age—and the influence of the TNM cT-stage. Overall, a trend of impaired functional and symptom scores was found across all surveys with few significances (body image −10.6 percentage points (pp) after one year; defecation problems +13.5 pp, insomnia +10.2 pp and weight loss +9.8 pp after three years; defecation problems +11.3 pp after four years). cT4-stage patients lost significantly more weight than their cT1-3-stage counterparts (+10.7 to 13.7 pp). Further studies should be conducted to find possible causes and develop countermeasures for future major infectious diseases. [ABSTRACT FROM AUTHOR]

Background There is limited knowledge of whether cognitive-behavioral therapy (CBT) or second-generation antipsychotics (SGAs) should be recommended as the first-line treatment in individuals at clinical high risk for psychosis (CHRp). Hypothesis To examine whether individual treatment arms are superior to placebo and whether CBT is non-inferior to SGAs in preventing psychosis over 12 months of treatment. Study Design PREVENT was a blinded, 3-armed, randomized controlled trial comparing CBT to clinical management plus aripiprazole (CM + ARI) or plus placebo (CM + PLC) at 11 CHRp services. The primary outcome was transition to psychosis at 12 months. Analyses were by intention-to-treat. Study Results Two hundred eighty CHRp individuals were randomized: 129 in CBT, 96 in CM + ARI, and 55 in CM + PLC. In week 52, 21 patients in CBT, 19 in CM + ARI, and 7 in CM + PLC had transitioned to psychosis, with no significant differences between treatment arms (P  = .342). Psychopathology and psychosocial functioning levels improved in all treatment arms, with no significant differences. Conclusions The analysis of the primary outcome transition to psychosis at 12 months and secondary outcomes symptoms and functioning did not demonstrate significant advantages of the active treatments over placebo. The conclusion is that within this trial, neither low-dose aripiprazole nor CBT offered additional benefits over clinical management and placebo. [ABSTRACT FROM AUTHOR]

Objectives The objective of this survey was to analyse vaccination rates and attitudes towards vaccination among health care workers (HCWs). The period prevalence of self-reported acute respiratory infections in the influenza season 2014/2015 was examined. Study design A cross-sectional study was conducted among HCWs of a German university hospital using an anonymised questionnaire. Recruitment was performed by providing all medical and nursing staff a paper questionnaire with an invitation to participate. Methods Descriptive aggregated data were generated from digitalised questionnaires for all variables. Differences in categorical variables were analysed by Chi-squared test. Textual data were analysed by an iterative process based on the grounded theory by Glaser and Strauss. Results The response rate was 31% (677/2186). Probable influenza was described by 9% (64/677) of the participants. The overall self-reported vaccination rate was 55% (366/666). Self-reported vaccination rate was higher in physicians (172/239, 72%) than in nursing staff (188/418, 45%). HCWs in paediatrics (103/148, 70%) more likely received vaccines than HCWs in surgery (31/84, 37%). Most vaccinations were provided by medical staff on the wards (164/368, 45%). Self-reported lost work-time due to adverse events after vaccination was low (6/336, 2%). Eight categories for vaccine refusal were identified, whereof doubts about effectiveness and indication of the vaccine was most frequently mentioned (72/202, 36%). Conclusions Efforts to promote vaccination should focus on nursing staff and should provide scientific evidence on effectiveness, adverse effects, and the benefits of health care workers' vaccination for patients. Administering vaccines at the workplace proved to be a successful strategy in our setting. Studies are needed to assess the frequency of influenza causing disease in HCWs. [ABSTRACT FROM AUTHOR]

Purpose: Previous research on motor speech disorders (MSDs) in primary progressive aphasia (PPA) has largely focused on patients with the nonfluent/ agrammatic variant of PPA (nfvPPA), with few systematic descriptions of MSDs in variants other than nfvPPA. There has also been an emphasis on studying apraxia of speech, whereas less is known about dysarthria or other forms of MSDs. This study aimed to examine the qualitative and quantitative characteristics of MSDs in a prospective sample of individuals with PPA independent of subtype. Method: We included 38 participants with a root diagnosis of PPA according to current consensus criteria, including one case with primary progressive apraxia of speech. Speech tasks comprised various speech modalities and levels of complexity. Expert raters used a novel protocol for auditory speech analyses covering all major dimensions of speech. Results: Of the participants, 47.4% presented with some form of MSD. Individual speech motor profiles varied widely with respect to the different speech dimensions. Besides apraxia of speech, we observed different dysarthria syndromes, special forms of MSDs (e.g., neurogenic stuttering), and mixed forms. Degrees of severity ranged from mild to severe. We also observed MSDs in patients whose speech and language profiles were incompatible with nfvPPA. Conclusions: The results confirm that MSDs are common in PPA and can manifest in different syndromes. The findings emphasize that future studies of MSDs in PPA should be extended to all clinical variants and should take into account the qualitative characteristics of motor speech dysfunction across speech dimensions. [ABSTRACT FROM AUTHOR]

Objective: This study aimed to determine the predictors of olfactory improvement after endoscopic sinus surgery among patients with chronic rhinosinusitis with nasal polyps. Method: This prospective cohort study included patients admitted to a university hospital between 2006 and 2012. Assessment using odour identification testing, a sinonasal symptom questionnaire, the Rhinosinusitis Disability Index and mucus biomarker levels was performed at various time points. Correlation of variables with identification score differences at six post-operative time points and at baseline was performed, followed by multiple linear regression to determine significant predictors at each of the six post-operative time points. Results: Baseline absence of acute sinusitis, elevated serpin F2 and anterior rhinorrhoea predict early olfactory improvement, whereas baseline allergic rhinitis predicts late olfactory improvement. Baseline odour identification score was the strongest predictor across all time points. Conclusion: Patients with chronic rhinosinusitis and nasal polyps with worse disease or baseline olfactory function may benefit more from endoscopic sinus surgery in terms of olfactory improvement. [ABSTRACT FROM AUTHOR]

Purpose: SARS‐CoV‐2 vaccines cause acute ipsilateral lymph node swelling in an important proportion of vaccines. Thus far, no malignant lymphadenopathies have been reported in temporal context to vaccination in the ipsilateral draining lymph node areas. Experimental design: Prompted by two cases with unilateral axillary lymphomas that occurred ipsilaterally to prior SARS‐CoV‐2 vaccination, we systematically retrieved all B‐cell non‐Hodgkin lymphomas at two German University Medical Centers diagnosed before and after introduction of SARS‐CoV‐2 vaccines in Germany. Available lymphoma tissue (n=19) was subjected to next‐generation immunosequencing of the IGH locus. Malignant clonotypes were mined in the CoVabDab database and published data sets from 342 uninfected individuals, 55 individuals 28 days after anti‐SARS‐CoV‐2 vaccination and 139 individuals with acute COVID‐19 together encompassing over 1 million CDR3 sequences in total. Results: Of 313 newly diagnosed cases in the two centers and observation periods, 27 unilateral manifestations in the defined deltoid draining regions were identified. The majority thereof were diffuse large B‐cell lymphomas (18 of 27 cases). Eleven unilateral cases were diagnosed in the era of SARS‐CoV‐2 vaccination and 16 in the control period before introduction of such vaccines. Of the 11 unilateral lymphomas that occurred during the vaccination period, ten had received a SARS‐CoV‐2 vaccine prior to lymphoma diagnosis. These cases were further evaluated. While left‐sided were more frequent than right‐sided lymphomas (19 vs 8 cases), no statistically significant association of vaccination site and laterality of the lymphoma manifestation was found. The unilateral lymphomas showed a normal range of B‐cell receptors typically found in these lymphoma subtypes with no evidence for anti‐SARS‐CoV‐2 sequences in the malignant clonotype. Conclusions: Together, we found no evidence that the current SARS‐CoV‐2 vaccines could serve as a trigger for lymphomagenesis in the draining lymph node areas of the deltoid region used for vaccination. [ABSTRACT FROM AUTHOR]

Background: Centers for rare diseases serve as contact points for patients with complex, often undiagnosed complaints and persistent somatic symptoms of heterogeneous origin. Little is known about psychological distress of patients consulting these centers. Objectives: To better understand psychological distress of adult patients presenting at a center for rare diseases by determining the proportion of patients screening positive for depressive, anxiety, and somatic symptom disorders (SSD) and to identify factors associated with increased psychopathology. Methods: Cross-sectional data from the routine care registry of the Martin Zeitz Center for Rare Diseases (MZCSE) at the University Medical Center Hamburg-Eppendorf in Germany was retrieved and analyzed. We included all adult patients presenting between October 01,2020 and September 30,2021, who gave written informed consent. Measures: Sociodemographic variables, medical history and healthcare utilization, as well as validated measures to screen for a depressive disorder (PHQ-8), an anxiety disorder (GAD-7), and SSD (PHQ-15, SSD-12). Results: N = 167 patients were included (age 44.5 ± 14.3 years, 64.7% female). A total of 40.7% of the patients screened positive for a depressive disorder (PHQ-8 ≥ 10), 27.5% for an anxiety disorder (GAD-7 ≥ 10) and 45.0% screened positive for SSD (PHQ-15 ≥ 9 & SSD-12 ≥ 23). Factors associated with increased psychopathology included the number of symptoms, the number of different specialties consulted before and past psychotherapy. Conclusions: Patients presenting at centers for rare diseases are likely to experience high rates of psychological distress. Systematically screening patients with rare and undiagnosed diseases for mental disorders can help to detect those at risk at an early stage and initiate adequate psychological care. [ABSTRACT FROM AUTHOR]

Simple Summary: Human papillomavirus (HPV) association is the most important predictor of survival in squamous cell carcinomas in the head and neck region (HNSCC). The role of HPV in cancer of unknown origin at this anatomic site (CUPHNSCC) is less well understood. The objective of this study was to identify prognostic classification markers in CUPHNSCC. Therefore, we investigated a consecutive cohort by multivariate modeling and testing for HPV DNA, mRNA, and p16INK4a (p16) expression. In 31% of CUPHNSCC, p16 was overexpressed, and high-risk HPV DNA was detected in 18/32 (56.3%) of them, which was mostly consistent with mRNA detection. In contrast to oropharyngeal cancer, detection of p16 without additional detailed HPV testing appears to be more appropriate for the classification of CUPHNSCC. Three risk groups can be stratified based on performance status and p16, but additional factors may become important in future data or for cases with particular risk profiles. Background: Human papillomavirus (HPV) status is the most important predictor of survival in oropharyngeal squamous cell carcinoma (OPSCC). In patients with cervical lymph node metastases of squamous cell carcinoma of unknown origin (CUPHNSCC), much less is known. Methods: We assessed a consecutive cohort of CUPHNSCC diagnosed from 2000–2018 for HPV DNA, mRNA, p16INK4a (p16) expression, and risk factors to identify prognostic classification markers. Results: In 32/103 (31%) CUPHNSCC, p16 was overexpressed, and high-risk HPV DNA was detected in 18/32 (56.3%). This was mostly consistent with mRNA detection. In recursive partitioning analysis, CUPHNSCC patients were classified into three risk groups according to performance status (ECOG) and p16. Principal component analysis suggests a negative correlation of p16, HPV DNA, and gender in relation to ECOG, as well as a correlation between N stage, extranodal extension, and tobacco/alcohol consumption. Conclusions: Despite obvious differences, CUPHNSCC shares similarities in risk profile with OPSCC. However, the detection of p16 alone appears to be more suitable for the classification of CUPHNSCC than for OPSCC and, in combination with ECOG, allows stratification into three risk groups. In the future, additional factors besides p16 and ECOG may become important in larger studies or cases with special risk profiles. [ABSTRACT FROM AUTHOR]

Background: Satisfaction with care is an important indicator of health care quality. However, if this process measure is associated with patients' outcomes in real-world data is largely unknown. We, therefore, aimed to evaluate if satisfaction with physician- and nurse-related care is associated with quality of life and self-rated health among inpatients at the University Hospital Hamburg-Eppendorf in Germany. Method: We used standard hospital quality survey data of 4925 patients treated at various departments. We used multiple linear regressions to examine an association between satisfaction with staff-related care and quality of life as well as self-rated health, adjusted for age, gender, mother tongue, and treating ward. Patients rated their satisfaction with physician- and nurse-related care from 0 "not at all" to 9 "very much". The outcomes regarding quality of life and self-rated health were evaluated on five-point Likert scales ranking from 1 "bad" to 5 "excellent". Results: We found that satisfaction with physician-related care was positively associated with quality of life (ß = 0.16; p < 0.001) as well as with self-rated health (ß = 0.16; p < 0.001). Similar findings were observed for satisfaction with nurse-related care and the two outcomes (ß = 0.13; p < 0.001 and ß = 0.14; p < 0.001, respectively). Conclusion: We show that patients who are more satisfied with staff-related care report better quality of life and self-rated health than patients less satisfied with care. Thus, patient satisfaction with care, is not only a process measure indicating the quality of care but is also positively associated with patient-reported outcomes. [ABSTRACT FROM AUTHOR]

Due to their likelihood for experiencing a number of traumatic events, refugee minors have an increased risk of developing post-traumatic stress disorder (PTSD). However, the prevalence of PTSD in refugee children varies widely between studies, and it remains somewhat unclear what factors increase children's risk of PTSD. This study aimed to assess the prevalence of PTSD in a clinical outpatient sample of refugee minors, and to evaluate the association of different risk factors with a PTSD diagnosis. N = 417 refugee minors were recruited from an outpatient clinical center in Hamburg, Germany. The median age was 15.4 years and 74.6% of the minors were male. As part of the standard diagnostic process, their social history and a potential PTSD diagnosis using the Module K of the Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) was assessed. The predictive value of age, gender, number of interpersonal traumatic events, un-/accompanied status, presence of family member in the host country, flight duration, residence status, and time since arrival in the host country were investigated using logistic regression analysis. The prevalence of PTSD among the young refugee patients was 61.6%. Significant predictors of a PTSD diagnosis were number of interpersonal traumatic life events, age, residence status, and time since arrival in the host country. The prediction model explained 33.8% of variance of the outcome with the number of interpersonal traumatic events having the largest contribution (20.8%). The high prevalence of PTSD among refugee minors in outpatient care emphasizes the need to establish appropriate care structures and train specialists in the treatment of PTSD. [ABSTRACT FROM AUTHOR]

This prospective one-year cohort study aimed to assess the feasibility and outcomes of a routine psychosocial screening at patients' admittance to specialist inpatient palliative care. Patients admitted to an academic palliative care ward were routinely screened for self-reported distress and psychological morbidity, psychosocial stress factors, and subjective need for help from psychosocial professions. Cognitive impairments were the most common patient barrier to screening. Screenings were completed in 138 of 428 patients (32%). Based on established cutoffs, distress was indicated in 89%, depression in 51%, and anxiety in 50% of these patients. The burden on next-of-kin emerged as the most prevalent stress factor (73%). One-half of the patients disclosed a subjective need for help (53%). Possible depression (p =.023), anxiety (p <.001), and subjective need for help (p <.001) correlated positively with a higher amount of time spent by psychologists and creative arts-based therapists with small to moderate effects. Patients who completed the screening were attributed with a higher amount of time by social workers than patients who did not (p =.004), but there were no relationships between screening results and social work. Results suggest the potential of screenings for the allocation of specialist psychosocial care during specialist palliative care; however, barriers to screening do exist. [ABSTRACT FROM AUTHOR]

This study aims at evaluating the use case potential of breast cancer care for artificial intelligence and blockchain technology application based on the patient data analysis at Marburg University Hospital and, thereupon, developing a digital workflow for breast cancer care. It is based on a retrospective descriptive data analysis of all in-patient breast and ovarian cancer patients admitted at the Department of Gynecology of Marburg University Hospital within the five-year observation period of 2017 to 2021. According to the German breast cancer guideline, the care workflow was visualized and, thereon, the digital concept was developed, premised on the literature foundation provided by a Boolean combination open search. Breast cancer cases display a lower average patient case complexity, fewer secondary diagnoses, and performed procedures than ovarian cancer. Moreover, 96% of all breast cancer patients originate from a city with direct geographical proximity. Estimated circumference and total catchment area of ovarian present 28.6% and 40% larger, respectively, than for breast cancer. The data support invasive breast cancer as a preferred use case for digitization. The digital workflow based on combined application of artificial intelligence as well as blockchain or distributed ledger technology demonstrates potential in tackling senological care pain points and leveraging patient data safety and sovereignty. [ABSTRACT FROM AUTHOR]

Objective: In Germany, multimodal psychosomatic inpatient treatment can be initiated for patients with substantial mental disorders (e.g., depression, anxiety, somatoform disorders) and comorbid physical disease. However, studies investigating changes in psychological and functional treatment outcomes, and predictors of long-term treatment effects in patients undergoing psychosomatic inpatient treatment are needed. Methods: This cohort study analyzed 160 patients aged ≥18 who were treated on an integrated psychosomatic inpatient unit at the University of Göttingen Medical Center. Its aim was to analyze changes in psychological and functional outcomes, and to identify predictors of long-term improvements in health-related quality of life (HRQoL) in patients with comorbid mental and physical illness who were undergoing integrated inpatient psychosomatic treatment. Assessments were completed at admission, discharge, and 12- or 24-month follow-up. Outcomes included physical complaints [Giessen Subjective Complaints List (GBB-24)], psychological symptoms [Brief Symptom Inventory (BSI)], and HRQoL [European Quality of Life Questionnaire (EQ-5D)]. Results: One-hundred sixty inpatients were included (mean age = 53.1 ± 12.6; 53.8% female). There were significant, medium- to large-sized improvements in psychological symptoms (BSI-Global Severity Index; d = −0.83, p < 0.001), physical symptom burden (d = −0.94, p < 0.001), and HRQoL (d = 0.65, p < 0.001) from admission to discharge, and significant, small- to medium-sized greater improvements in all psychological outcomes from admission to follow-up (BSI-GSI: d = −0.54, p < 0.001; GBB-24 total symptom burden: d = −0.39, p < 0.001; EQ-5D: d = 0.52, p < 0.001). Furthermore better improvement in HRQoL during hospitalization (partial η² = 0.386; p < 0.001) was associated with higher HRQoL at follow-up. Finally, intake of antidepressant at discharge was associated with impaired HRQoL at follow-up (η² = 0.053; p = 0.03). Conclusion: There were significant short- and long-term improvements in psychological symptoms, physical complaints, and HRQoL after treatment on an integrated psychosomatic inpatient unit in patients with mental disorders and a comorbid physical disease. [ABSTRACT FROM AUTHOR]

Simple Summary: Pancreatic ductal adenocarcinoma (PDAC) is frequently seen in elderly patients. The aim of our retrospective study was to evaluate the impact of age on postoperative short-term and long-term outcomes in patients undergoing curative pancreatic resection for PDAC. Our data confirm that pancreatic resections can be performed with equal short-term outcomes even in older age. However, patient age significantly influenced the overall and disease-free survival of patients with PDAC undergoing primary resection in curative intent. Therefore, the choice of the optimal therapy concept for each patient should be individualized taking into account the patient's age. (1) Purpose: to evaluate the impact of age on postoperative short-term and long-term outcomes in patients undergoing curative pancreatic resection for PDAC. (2) Methods: This retrospective single-center study comprised 213 patients who had undergone primary resection of PDAC from January 2000 to December 2018 at the University Hospital of Erlangen, Germany. Patients were stratified according the age into two groups: younger (≤70 years) and older (>70 years) patients. Postoperative outcome and long-term survival were compared between the groups. (3) Results: There were no significant differences regarding inhospital morbidity (58% vs. 67%, p = 0.255) or inhospital mortality (2% vs. 7%, p = 0.073) between the two groups. The median overall survival (OS) and disease-free survival (DFS) were significantly shorter in elderly patients (OS: 29.2 vs. 17.1 months, p < 0.001, respectively; DFS: 14.9 vs. 10.4 months, p = 0.034). Multivariate analysis revealed that age was a significant independent prognostic predictor for OS and DFS (HR 2.23, 95% CI 1.58–3.15; p < 0.001 for OS and HR 1.62, 95% CI 1.17–2.24; p = 0.004 for DFS). (4) Conclusion: patient age significantly influenced overall and disease-free survival in patients with PDAC undergoing primary resection in curative intent. [ABSTRACT FROM AUTHOR]