Neuroanatomical Predictors of Transcranial Direct Current Stimulation (tDCS)-Induced Modifications in Neurocognitive Task Performance in Typically Developing Individuals.

Transcranial direct current stimulation (tDCS) is a noninvasive neuromodulation technique gaining more attention in neurodevelopmental disorders (NDDs). Due to the phenotypic heterogeneity of NDDs, tDCS is unlikely to be equally effective in all individuals. The present study aimed to establish neuroanatomical markers in typically developing (TD) individuals that may be used for the prediction of individual responses to tDCS. Fifty-seven male and female children received 2 mA anodal and sham tDCS, targeting the left dorsolateral prefrontal cortex (DLPFCleft), right inferior frontal gyrus, and bilateral temporoparietal junction. Response to tDCS was assessed based on task performance differences between anodal and sham tDCS in different neurocognitive tasks (N-back, flanker, Mooney faces detection, attentional emotional recognition task). Measures of cortical thickness (CT) and surface area (SA) were derived from 3 Tesla structural MRI scans. Associations between neuroanatomy and task performance were assessed using general linear models (GLM). Machine learning (ML) algorithms were employed to predict responses to tDCS. Vertex-wise estimates of SA were more closely linked to differences in task performance than measures of CT. Across ML algorithms, highest accuracies were observed for the prediction of N-back task performance differences following stimulation of the DLPFCleft, where 65% of behavioral variance was explained by variability in SA. Lower accuracies were observed for all other tasks and stimulated regions. This suggests that it may be possible to predict individual responses to tDCS for some behavioral measures and target regions. In the future, these models might be extended to predict treatment outcome in individuals with NDDs.

Multicenter clinical trial on functional evaluation of transoral laser microsurgery for supraglottic laryngeal carcinomas.

BACKGROUND: Transoral laser microsurgery (TLM) is an accepted and effective treatment strategy for supraglottic carcinomas. Data on oncologic and to a lesser extent functional outcomes have been published by mainly European specialized single institutions. TLM for supraglottic carcinomas has never been tested in a multicenter trial on its applicability as surgical standard at every hospital. OBJECTIVES: To test the efficacy of TLM supraglottic laryngectomy (TLM-SGL) in terms of swallowing function, oncologic outcome parameters, morbidity, complications of treatment, and quality of life in a multicenter setting. METHODS: The study is designed as a multicenter (approximately 25 centers), non-randomized, single-arm study with a targeted number of 200 previously untreated patients with squamous cell carcinomas (SCC) of the supraglottic larynx T2/T3 N0-3 M0; UICC stage II-IVa. The surgical treatment consists of TLM-SGL and elective or therapeutic uni- or bilateral selective neck dissection (SND). After pathologic risk stratification adjuvant radio- (RT) or radiochemotherapy (RCT) is indicated. Patients are followed-up for 2 years post surgically. Swallowing function is assessed by fibreoptic endoscopic evaluation of swallowing (FEES). The primary endpoint is aspiration-free swallowing at 12 months as established using FEES and defined as grade < 6 of penetration-aspiration scale (PAS). Secondary endpoints include local control, larynx preservation, overall and disease-free survival, complications and side effects of treatment, prevalence of tracheostomy and percutaneous endoscopic gastrostomy (PEG)-tube-feeding, and dysphagia-specific quality of life (QoL) assessed by the MD Anderson Dysphagia Inventory (MDADI) as well as voice-related QoL assessed by the Voice Handicap Index (VHI).

Challenging the Sensitive Window Hypothesis: Timing Effects of Maternal Depressive Symptoms on the Intergenerational Transmission of Maltreatment and Psychopathology in the Next Generation.

OBJECTIVE: The current study explored the role of maternal depressive symptoms in the intergenerational transmission of childhood maltreatment and developmental psychopathology. Based on the sensitive window hypothesis, the effects of earlier versus later maternal depression symptoms on child development were analysed. METHOD: Ninety-nine mother-child dyads, 65% of which had high-risk teenage mothers, participated in a longitudinal study with three assessments in the first 18 months of the child's life (T1-T3) and a 4th reassessment (T4) at the child's preschool age. Using serial mediation analyses, we tested whether the relationship between the mother's own maltreatment history (Childhood Experience of Care and Abuse Questionnaire) and the child's psychopathological outcome at preschool age was mediated in a causal effect chain by maternal depression in the first 2 years of life, by current maternal depression (Beck Depression Inventory-II) and by current maternal child abuse potential (Child Abuse Potential Inventory). The children's emotional problems and externalizing symptoms were assessed at preschool age by parent or teacher Strengths and Difficulties Questionnaire ratings. RESULTS: The results indicated that especially later maternal depression mediated the relationship between maternal childhood maltreatment and negative developmental outcomes in the next generation. The effects of maltreatment type on maternal depression were rather nonspecific. However, mental abuse affected existing risk factors more directly over time compared to physical and sexual abuse. Additionally, the impact of early life maltreatment and maternal depression on child psychopathology varied by rater. The pathway to externalizing symptoms was significant only in teacher ratings and for the pathway to emotional problems only in maternal ratings. CONCLUSIONS: The present findings suggest that early maternal depression followed by ongoing maternal depression plays a mediating role in the intergenerational cycle of maltreatment. Therefore, in the future, interventions should be offered at an early stage, but also extend well beyond the first 2 years of a child's life, addressing maternal depression and trauma.

[Changes in the routine work and moral distress in psychiatric care during the COVID-19 pandemic : A survey among physicians active in inpatient care in Germany]. / Änderungen des Arbeitsalltags und Moral Distress in der psychiatrischen Versorgung während der COVID-19-Pandemie : Eine Umfrage unter stationär tätigen Ärzt*innen in Deutschland.

BACKGROUND: During the COVID-19 pandemic a number of ethical challenges have arisen in the healthcare system. A psychological response to moral challenges is termed moral distress (MD). OBJECTIVE: Identification of causes of MD in inpatient psychiatric care in the context of the COVID-19 pandemic in Germany. MATERIAL AND METHODS: A survey was conducted using a self-administered non-validated online questionnaire as part of a cross-sectional study, in which 26 items about the experience of MD were examined and open questions about the handling of the pandemic and its effects on everyday work were posed. Physicians who worked in inpatient psychiatric care during the COVID-19 pandemic in Germany were surveyed anonymously with a convenience sample. The data acquisition took place between 17 November 2020 and 6 May 2021. RESULTS: A total of 141 participants were included. They indicated multiple pandemic-related changes in their daily work partly resulting in MD. CONCLUSION: MD is a neglected potential burden of inpatient psychiatric care under pandemic conditions (and beyond), which requires further research and an adequate handling. These results include implications for decision makers in crisis teams as well as a need for support services such as clinical ethics consultation services.

Coronary Artery Bypass Grafting in Patients with Acute Myocardial Infarction and Cardiogenic Shock.

Objective: Acute myocardial infarction (AMI) complicated by cardiogenic shock (CS) remains associated with a high rate of mortality and disabling morbidity. Coronary artery bypass grafting (CABG) is seldom considered in this setting due to the fear of peri-operative complications. Here, we analysed the outcome of CS patients undergoing CABG within 48 hours after diagnosed with AMI. Methods: A single-center, retrospective data analysis was performed in 220 AMI patients with CS that underwent CABG within 48 hours between 01/2001 and 01/2018. Results: 141 patients were diagnosed with ST-elevation myocardial infarction (STEMI), 79 with non-STEMI (NSTEMI). Median age was 67 (60; 72) for STEMI, and 68 (60.8; 75.0) years for NSTEMI patients (p = 0.190). 52.5% of STEMI patients and 39.2% of NSTEMI patients had suffered from cardiac arrest (CA) pre-operatively (p = 0.049). Coronary 3-vessel disease was present in most patients (78.0% STEMI vs 83.5% NSTEMI; p = 0.381). Percutaneous coronary interventions (PCI) were performed in 32.6% STEMI and 27.8% NSTEMI patients (p = 0.543) prior to surgery. Time from diagnosis to surgery was shorter in STEMI patients (3.92 (2.67; 5.98) vs 7.50 (4.78; 16.74) hours; p < 0.001). A complete revascularization was achieved in 82.3% of STEMI and 73.4% of NSTEMI cases (p = 0.116). Post-operative low cardiac output occurred in 14.2% of STEMI vs 8.9% of NSTEMI patients (p = 0.289). The rate of cerebrovascular injury-including hypoxic brain damage was 12.1% for STEMI and 10.1% among NSTEMI patients. (p = 0.825). 30-day mortality was 32.6% after STEMI vs 31.6% in NSTEMI cases (p = 0.285). Conclusions: In contrast to the discouraging data concerning the role of PCI in AMI patients with CS and complex coronary artery disease, CABG may represent a treatment option worth considering.

Mobilization in the evening to prevent delirium: A pilot randomized trial.

BACKGROUND: Delirium is a common complication in patients in Intensive Care Units (ICU). Interventions such as mobilization are effective in the prevention and treatment of delirium, although this is usually completed during the daytime. AIM: The aim of this study was to assess the feasibility of mobilization in the evening to prevent and treat ICU patients from delirium by an additional mobility team over 2 weeks. METHODS: The design was a pilot, multi-centre, randomized, controlled trial in four mixed ICUs over a period of 2 weeks. The mobility team consisted of trained nurses and physiotherapists. Patients in the intervention group were mobilized onto the edge of the bed or more between 21.00 and 23.00. Patients in the control group received usual care. The primary outcome parameter was the feasibility of the study, measured as recruitment rate, delivery rate, and safety. Secondary outcomes were duration and incidence of delirium, mortality, duration of mechanical ventilation (MV), and hospital length of stay for 28 days follow-up, and power calculation for a full trial. RESULTS: Out of 185 patients present in the ICUs, 28.6% (n = 53) were eligible and could be recruited, of which 24.9% (n = 46, Intervention = 26, Control = 20) were included in the final analysis. In the intervention group, mobilization could be delivered in 75% (n = 54) of 72 possible occasions; mobilization-related safety events appeared in 16.7% (n = 9) without serious consequences. Secondary parameters were similar, with less delirium in the intervention group albeit not significant. With an association of Cramer's V = 0.237, a complete study reaching statistical significance would require at least 140 patients, last 6 weeks, and cost >30 000 €. CONCLUSIONS: In a mixed ICU population, mobilization in the evening was feasible in one-quarter of patients with a low rate of safety events. Future trials seem to be feasible and worth conducting.

Risks and neurological benefits of meningioma surgery in elderly patients compared to young patients.

INTRODUCTION: While surgery is the primary treatment choice for intracranial meningiomas in young patients, surgery in elderly patients, especially those with pre-existing comorbidities, has been the subject of repeated discussion. This study investigated the postoperative risks and neurological benefits of meningioma surgery in elderly patients compared to young patients. METHODS: In total, 768 patients were included and divided into two main groups: group I (age: ≤ 64 years; 484 young patients) and group II (age: ≥ 65 years; 284 elderly patients). Group II was subdivided into: IIa (age: 65-69 years), IIb (age: 70-79 years); and IIc (age: ≥ 80 years). RESULTS: The total tumor resection rate was higher in the elderly cohort than in the young cohort (84.5 and 76.2%, respectively). 154 young patients (31.8%) and 132 elderly patients (46.5%) developed postoperative morbidities, with the three most common being bleeding (12.9%), cranial nerve disorder (10%) and CSF fistula (8.1%). Postoperative bleeding, palsy, speech disorder, pneumonia and renal insufficiency were dependent on age (r = 0.123, p = 0.001; r = 0.089, p = 0.014; r = 0.100, p = 0.006; r = 0.098, p = 0.007 and r = 0.084, p = 0.020) and presented more often in elderly patients. 6 young and 15 elderly patients died during the 17.4-year observation period. Most patients showed a significant improvement in postoperative KPS (p < 0.001), except those over 80 years old (p = 0.753). The KPS at the last follow-up was significantly improved in all patients (p < 0.001). CONCLUSION: Meningioma surgery is associated with a higher rate of postoperative complications in elderly patients than in young patients. Most elderly patients, similar to young patients, show a significant improvement in neurological status postoperatively.

Consent to research participation: understanding and motivation among German pupils.

BACKGROUND: The EU's 2006 Paediatric Regulation aims to support authorisation of medicine for children, thus effectively increasing paediatric research. It is ethically imperative to simultaneously establish procedures that protect children's rights. METHOD: This study endeavours (a) to evaluate whether a template consent form designed by the Standing Working Group of the German-Research-Ethics-Committees (AKEK) adequately informs adolescents about research participation, and (b) to investigate associated phenomena like therapeutic misconception and motives for research participation. In March 2016 a questionnaire study was conducted among 279 pupils (mean age 13.1 years) of a secondary school in northern Germany. RESULTS: A majority of participants showed a general good understanding of foundational research ethics concepts as understood from the AKEK consent form. Nevertheless, our data also suggests possible susceptibility to therapeutic misconception. Own health concerns and pro-social considerations were found to be significant motivational factors for participating in research, while anticipation of pain lessens likelihood of participation. Advice from trusted others is an important decisional influence, too. Furthermore, data security was found to be a relevant aspect of adolescents' decision-making process. CONCLUSION: Bearing in mind adolescents' generally good understanding, we infer the lack of knowledge about medical research in general to be one source of therapeutic misconception. To further improve the quality of consent we propose a multi-staged approach whereby general research education is completed before an individual becomes a patient or potential participant. To the best of our knowledge this is the first German questionnaire-study addressing issues of informed consent in a large under-age sample.

Secondary research use of personal medical data: patient attitudes towards data donation.

BACKGROUND: The SARS-CoV-2 pandemic has highlighted once more the great need for comprehensive access to, and uncomplicated use of, pre-existing patient data for medical research. Enabling secondary research-use of patient-data is a prerequisite for the efficient and sustainable promotion of translation and personalisation in medicine, and for the advancement of public-health. However, balancing the legitimate interests of scientists in broad and unrestricted data-access and the demand for individual autonomy, privacy and social justice is a great challenge for patient-based medical research. METHODS: We therefore conducted two questionnaire-based surveys among North-German outpatients (n = 650) to determine their attitude towards data-donation for medical research, implemented as an opt-out-process. RESULTS: We observed a high level of acceptance (75.0%), the most powerful predictor of a positive attitude towards data-donation was the conviction that every citizen has a duty to contribute to the improvement of medical research (> 80% of participants approving data-donation). Interestingly, patients distinguished sharply between research inside and outside the EU, despite a general awareness that universities and public research institutions cooperate with commercial companies, willingness to allow use of donated data by the latter was very low (7.1% to 29.1%, depending upon location of company). The most popular measures among interviewees to counteract reservations against commercial data-use were regulation by law (61.4%), stipulating in the process that data are not sold or resold (84.6%). A majority requested control of both the use (46.8%) and the protection (41.5%) of the data by independent bodies. CONCLUSIONS: In conclusion, data-donation for medical research, implemented as a combination of legal entitlement and easy-to-exercise-right to opt-out, was found to be widely supported by German patients and therefore warrants further consideration for a transposition into national law.

'Therapists in action'-Home treatment in adolescent anorexia nervosa: A stepped care approach to shorten inpatient treatment.

OBJECTIVE: It was the aim of this pilot study to apply a novel eating disorder (ED)-specific home treatment (HoT) to adolescents with anorexia nervosa (AN) and to investigate its feasibility, effects and safety. METHOD: Twenty-two patients consecutively admitted to the hospital and fulfilling DSM-5 criteria for typical or atypical AN received HoT after 4-8 weeks of inpatient treatment. During the first two months of HoT, the patient and her family were visited on average three to four times per week, during the third and fourth months of HoT once or twice a week by a multi-professional team. Body mass index, ED and general psychopathology, quality of life and treatment satisfaction were assessed in the patients at admission, start and end of HoT and the 1-year follow-up as well as carers' skills and burden. RESULTS: The majority of patients successfully achieved target weight within HoT and maintained it successfully at the 1-year follow-up. ED and general psychopathology in the patients and carers' skills improved significantly associated with a high treatment satisfaction. CONCLUSIONS: HoT seems to be a promising new tool to improve outcome in adolescent AN and to reduce time of hospitalisation. Larger randomised controlled trials are needed to generalise these results.

[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.

Dasatinib prevents skeletal metastasis of osteotropic MDA-MB-231 cells in a xenograft mouse model.

PURPOSE: Bone metastasis in breast cancer has been linked to activity of c-Src kinase, one of the extensively explored tyrosine kinases in cell biology. The impact of TNF-related apoptosis inducing ligand (TRAIL) and TRAIL receptors has just recently been integrated into this conception. METHODS: An osteotropic clone of MDA-MB-231 cells simulated a model for bone metastasis of triple-negative breast cancer (TNBC). The effects of Dasatinib, a clinically established inhibitor of Src kinases family and Abl were evaluated in vitro and in vivo. In vivo effects of Dasatinib treatment on the occurrence of skeletal metastases were tested in a xenograft mouse model after intra-cardiac injection of osteotropic MDA-MB-231-cells. Ex vivo analyses of the bone sections confirmed intraosseous growth of metastases and allowed determination of osteoclastic activity. RESULTS: Treatment of osteotropic MDA-MB-231 cells with Dasatinib inhibited proliferation rates in vitro. A shift in TRAIL-receptor expression towards an induction of oncogenic TRAIL-R2 was observed. In vivo, 15 of 30 mice received an intra-peritoneal treatment with Dasatinib. These mice showed significantly less skeletal metastases in bioluminescence scans. Moreover, a pronounced increase in bone volume was observed in the treatment group, as detected by µ-Computed Tomography. Dasatinib treatment also led to a greater increase in bone density in tibiae without metastatic affection, which was accompanied by reduced recruitment of osteoclasts. CONCLUSION: Our observations support the concept of utilizing Dasatinib in targeting early-stage bone metastatic TNBC and sustaining bone health.

PROtocol-based MObilizaTION on intensive care units: stepped-wedge, cluster-randomized pilot study (Pro-Motion).

BACKGROUND: Early mobilization of patients in intensive care units (ICUs) improves patient recovery, but implementation remains challenging. Protocols may enhance the rate of out-of-bed mobilizations. AIM: To evaluate the effect of implementing a protocol for early mobilization on the rate of out-of-bed mobilizations and other outcomes of ICU patients. STUDY DESIGN: Multicentre, stepped-wedge, cluster-randomized pilot study. METHODS: After a control period, five ICUs were allocated to the implementation of an inter-professional protocol for early mobilization in a randomized, monthly order. Mobilization of ICU patients was evaluated by monthly 1-day point prevalence surveys using the ICU Mobility Scale. The primary outcome was the percentage of patients mobilized out of bed, defined as level 3 on the ICU Mobility Scale (sitting on edge of bed) or higher. Secondary outcomes were mechanical ventilation, delirium and ICU- and hospital-days, as well as unwanted safety events. RESULTS: Out-of-bed mobilizations increased non-significantly from 36·2% (n = 55) of 152 patients during the control period to 45·8% (n = 55) of 120 patients during the intervention period (difference 9·6%; 95% confidence interval -2·1 to 21·3%). Of 55 mobilized patients per group, more patients were mobilized once per day during the intervention period (intervention: n = 41 versus control: n = 23 patients). Multiple daily mobilizations decreased (control: n = 32 control versus intervention: n = 14 patients). Secondary outcomes, such as days with mechanical ventilation, delirium and in ICU and hospital, did not significantly differ. Adherence to the protocol was >90%; unwanted safety events were rare. CONCLUSIONS: Implementing a protocol for early mobilization of ICU patients showed a trend towards more patients being mobilized. Without additional staff in participating ICUs, a significant increase in ICU mobilizations was not to be anticipated. More research should address whether more staff would increase the number of frequent mobilizations and if this is relevant to outcomes. RELEVANCE TO CLINICAL PRACTICE: Implementing inter-professional protocols for mobilization is feasible and safe and may contribute to an increase of ICU patients mobilized out of bed.

Experience in Rehabilitation Medicine Affects Prognosis and End-of-Life Decision-Making of Neurologists: A Case-Based Survey.

BACKGROUND: Outcome predictions in patients with acute severe neurologic disorders are difficult and influenced by multiple factors. Since the decision for and the extent of life-sustaining therapies are based on the estimated prognosis, it is vital to understand which factors influence such estimates. This study examined whether previous professional experience with rehabilitation medicine influences physician decision-making. METHODS: A case vignette presenting a typical patient with an extensive brain stem infarction was developed and distributed online to clinical neurologists. Questions focused on prognosis, interpretation of an advanced directive, whether to withdraw life-sustaining treatments and information on prior rehabilitation experience from the survey respondent. RESULTS: Of the participating neurologists, 77% opted for the withdrawal of life-sustaining therapies (n = 70; response rate: 14.8%). This decision was not affected by age, gender, or length of clinical experience. Neurologists with experience in rehabilitation medicine tended to estimate a more positive prognosis than neurologists without, but this result was not significant (p = .13). There was an association between the intervention chosen and previous experience in rehabilitation; neurologists with experience in rehabilitation medicine opted significantly more often (31.8%) for continuing life-sustaining treatments than neurologists without such experience (8.7%, p = .04). CONCLUSION: Our results indicate that there are subjective factors influencing decisions to limit life-sustaining treatments that are based on previous professional experience. This finding emphasizes the variability and cognitive bias of such decision processes and should be integrated into future guidelines for specialist training on end-of-life decision-making.

Lost in virtual gaming worlds: Grit and its prognostic value for online game addiction.

BACKGROUND AND OBJECTIVES: The personality construct grit is defined as the ability to be persistent in pursuit of long-term goals in spite of challenges or obstacles. Grit is an emerging concept in positive psychology and has gained much attention because of its relevance for success and well-being across different domains. The aim of the present study was to examine the prognostic value of grit for online game addiction. METHODS: We surveyed German speaking online gamers (N = 305: 193 males and 112 females, Mage = 28.44 years, SDage = 8.88) in an online cross-sectional self-report study. We measured grit with the German version of the Short Grit Scale (BISS-8), online game addiction with the short version of the Game Addiction Scale (GAS), and participants' age and gender. RESULTS: Structural equation modeling supported the higher-order factor structure of grit in our sample (χ2 [18] = 29.31, p < .05; CFI = .980; TLI = .969; RMSEA = .045; SRMR = .038). A logistic regression revealed that both grit (OR = 0.62, 95%CI [.42; .89], p < .05) as well as age (OR = .92, 95%CI [.88; .97], p < .01) significantly reduced the likelihood of being addicted to online games. DISCUSSION AND CONCLUSIONS: In line with previous research on grit in patients with substance use disorders, we found grit to be a protective factor against online game addiction. We concluded that higher grit scores and older ages decrease the likelihood of being addicted to online games. SCIENTIFIC SIGNIFICANCE: This study provides initial support for the clinical relevance of grit for online game addiction. (Am J Addict 2018;XX:1-6).

Intra- and inter-rater reliability of the modified ENT assessment score (ENTAS 2) in granulomatosis with polyangiitis: a prospective randomised trial.

OBJECTIVES: Ears nose and throat (ENT) involvement is found on a substantial proportion of patients with granulomatosis with polyangiitis (GPA). Structured, reliable ENT assessment is essential in the management of GPA patients. It is the aim of this study to determine the repeatability (intra-rater reliability) and reproducibility (inter-rater reliability) of the ENT Assessment Score (ENTAS 2). METHODS: The ENTAS 2 built the fundament of the prospective randomized trial. Anamnestic, video endoscopic and diagnostic data of 47 patients were used. A single assessor reference was created. GPA/ENT activity and damage were evaluated by three physicians at two time points (T1/T2). GPA/ENT activity was evaluated in dichotomy (yes/no) and grading (none/mild/moderate/high) and GPA/ ENT damage in dichotomy. RESULTS: ENTAS 2 activity evaluations intra-rater reliability was 80.7% (κ=0.56) in dichotomy and 72.8% (κ=0.41) in grading. ENTAS 2 damage evaluations showed 87.8% (κ=0.74) intra-rater reliability. ENTAS 2 activity inter-rater reliability at T1 was 62.2% (κ=0.43) in dichotomy and 51.1% (κ=0.29) in grading, at T2 it was 68.2% (κ=0.48) in dichotomy and 55.32% (κ=0.33) in grading. Inter-rater reliability of ENTAS 2 damage evaluation was 84.4% (κ=0.79) at T1 and 72.5% (κ=0.64) at T2. CONCLUSIONS: ENTAS 2 intra-rater reliability was high in dichotomous and graded GPA/ENT activity and damage evaluations. Inter-rater reliability was high in dichotomous activity and damage evaluations, but low in graded activity evaluations. The data demonstrate that the ENTAS 2 is a reliable score-system considering GPA/ENT activity and damage evaluations.

Ocular Trauma Score as prognostic value in traumatic ocular injuries due to rotating wire brushes.

PURPOSE: Rotating wire brushes are used, e.g., for rust removal. Detaching fragments can cause severe eye injuries. The purpose of this study was to investigate mechanism, severity, clinical outcome, validity of Ocular Trauma Score (OTS) and to assess the likelihood of final visual acuity. METHODS: Twenty patients with traumatic ocular injuries by rotating wire brushes were included. Location and type of injury, grade of injury according to OTS, surgical procedure, and development of visual acuity were evaluated. RESULTS: Eleven accidents (55%) happened at work, nine at home (45%). Eighteen injuries (90%) were penetrating, one (5%) was perforating. In one case (5%), an intraocular foreign body was present. One case each was classified OTS 1 and 2 (5%), six cases OTS 3 (30%), four cases OTS 4 (20%), and eight cases OTS 5 (40%). None of the patients was wearing safety goggles. Fourteen patients (70%) were surgically treated. Of these, five were treated at the anterior segment only, nine additionally underwent pars-plana vitrectomy. Nine patients received phacoemulsification. Mean best corrected visual acuity was logMAR 1.0 (2/20) at admission and 0.3 (10/20) at last follow-up. Our results were similar to those in the OTS study, except for OTS 1 (p = 0.046). Comparing the categorical distribution of final visual acuity in all OTS categories, no statistically significant difference was found (p = 0.119) between our results and the OTS study group. CONCLUSIONS: OTS may provide prognostic information in traumatic ocular injuries by rotating wire brushes. The injuries could have been avoided by wearing safety goggles.

Transoral laser microsurgery for supraglottic carcinomas: results of a prospective multicenter trial (SUPRATOL).

Background: A limited number of single institutions have published retrospective cohort studies on transoral laser microsurgery for supraglottic laryngectomy (TLM-SGL). These studies have shown that the oncologic outcomes of TLM-SGL are comparable to those of open SGL. However, there is limited information available regarding swallowing rehabilitation and quality of life (QoL). Patients and methods: SUPRATOL is a prospective, multicenter trial assessing the functional outcomes of TLM-SGL +/- adjuvant radio-(chemo)-therapy. The primary endpoint was aspiration-free swallowing at 12 months, as established using fibreoptic endoscopic evaluation of swallowing (FEES) and defined as a grade < 6 on the penetration-aspiration scale. Secondary endpoints were swallowing- and voice-related QoL, the prevalence of temporary and permanent tracheostomy and percutaneous gastrostomy, local control, laryngectomy-free survival, overall survival, and disease-free survival, as well as the influence of treatment centers on outcomes. Results: From April 2015 to February 2018, 102 patients were recruited from 26 German Otorhinolaryngology (ORL) hospitals. All patients had TLM-SGL and 96.1% underwent uni- or bilateral, mostly selective neck dissection. To 47.0% of patients, adjuvant radio-(chemo)-therapy (R(C)T) was administered. The median follow-up period was 24.1 months. At 12-month follow-up, completed by 84.3% of patients, 98.2%, 95.5%, and 98.8% were free of aspiration when tested with saliva, liquid, or pulp. Adjuvant R(C)T, pT category, and type of resection had no significant influence on swallowing rehabilitation. A total of 40.2% of patients had been tracheotomized, and in 46.1% of patients, a PEG tube was inserted. At the 24-month follow-up, 5.3% of patients still required a tracheostomy, and 8.0% continued to use a percutaneous endoscopic gastrostomy (PEG) tube. Deterioration of swallowing- and voice-related QoL was observed immediately after treatment, but patients recovered, and baseline values were reached again. The Kaplan-Meier 2-year rates for local control, laryngectomy-free survival, overall survival, and disease-free survival were 88%, 92%, 93%, and 82%, respectively. Conclusions: Our prospective multicenter trial shows that, at 12 months post-TLM-SGL +/- R(C)T, 95.5%-98.8% of patients achieved aspiration-free swallowing. Morbidity was higher than previously reported. The rates of permanent tracheostomy and gastrostomy tube placement correspond to previous cohort studies. The 2-year oncologic outcomes are within the reported range. Clinical trial registration: https://drks.de/search/en/trial/DRKS00004641, identifier (DRKS00004641).

The influence of diagnoses on patient satisfaction during inpatient stays: A prospective study.

The aim of this study was to assess patient satisfaction relating to inpatient stays. In this prospective observational study, adult patients with oncological (oral cancer, medication-related osteonecrosis of the jaw) and non-oncological (mandibular fracture) diagnoses, and who had undergone surgery, were contacted 4 weeks after discharge. Two validated questionnaires were used: EORTC QLQ-C30 for quality of life and IN-PATSAT32 for patient satisfaction. For quality of life, the mandibular fracture group had a lower impairment of physical functioning (M = 83.59, SD = 24.44; p = 0.029) in comparison with both other groups (M = 68.84, SD = 26.24; M = 59.33, SD = 24.43, for oral cancer and osteonecrosis, respectively). Regarding patient satisfaction, patients with oral cancer were slightly more satisfied with doctors' availability (M = 48.91, SD = 24.11; p = 0.583) compared with the other groups (M = 36.54, SD = 19.11; M = 46.67, SD = 20.86, for mandibular fracture and ostenecrosis, respectively). Patients with an unplanned inpatient stay following an acute event tended to be less satisfied than patients with a planned inpatient stay. Within the limitations of the study it seems that knowledge of these influencing external factors and their effects can support physicians and nursing staff in providing improved patient care.

Long-term follow-up of patients with complex coronary artery disease treated with minimally invasive direct coronary artery bypass.

BACKGROUND: Patients with complex coronary artery disease (CAD) may benefit from surgical myocardial revascularization but weighing the risk of peri-operative complications against the expected merit is difficult. Minimally invasive direct artery bypass (MIDCAB) procedures are less invasive, provide the prognostic advantage of operative revascularization of the left anterior descending artery and may be integrated in hybrid strategies. Herein, the outcomes between patients with coronary 1-vessel disease (1-VD) and patients with 2-VD and 3-VD after MIDCAB procedures were compared in this single-center study. METHODS: Between 1998 and 2018, 1363 patients underwent MIDCAB at the documented institution. 628 (46.1%) patients had 1-VD, 434 (31.9%) patients 2-VD and 300 (22.0%) patients suffered from 3-VD. Data of patients with 2-VD, and 3-VD were pooled as multi-VD (MVD). RESULTS: Patients with MVD were older (66.2 ± 10.9 vs. 62.9 ± 11.2 years; p < 0.001) and presented with a higher EuroScore II (2.10 [0.4; 34.2] vs. 1.2 [0.4; 12.1]; p < 0.001). Procedure time was longer in MVD patients (131.1 ± 50.3 min vs. 122.2 ± 34.5 min; p < 0.001). Post-operatively, MVD patients had a higher stroke rate (17 [2.3%] vs. 4 [0.6%]; p = 0.014). No difference in 30-day mortality was observed (12 [1.6%] vs. 4 [0.6%]; p = 0.128). Survival after 15 years was significantly lower in MVD patients (p < 0.01). Hybrid procedures were planned in 295 (40.2%) patients with MVD and realized in 183 (61.2%) cases. MVD patients with incomplete hybrid procedures had a significantly decreased long-term survival compared to cases with complete revascularization (p < 0.01). CONCLUSIONS: Minimally invasive direct coronary artery bypass procedures are low-risk surgical procedures. If hybrid procedures have been planned, completion of revascularization should be a major goal.