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).

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.

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.

[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.

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.

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.

Severity, predictors and clinical correlates of Post-COVID syndrome (PCS) in Germany: A prospective, multi-centre, population-based cohort study.

Background: Post-COVID syndrome (PCS) is an important sequela of COVID-19, characterised by symptom persistence for >3 months, post-acute symptom development, and worsening of pre-existing comorbidities. The causes and public health impact of PCS are still unclear, not least for the lack of efficient means to assess the presence and severity of PCS. Methods: COVIDOM is a population-based cohort study of polymerase chain reaction (PCR) confirmed cases of SARS-CoV-2 infection, recruited through public health authorities in three German regions (Kiel, Berlin, Würzburg) between November 15, 2020 and September 29, 2021. Main inclusion criteria were (i) a PCR confirmed SARS-CoV-2 infection and (ii) a period of at least 6 months between the infection and the visit to the COVIDOM study site. Other inclusion criteria were written informed consent and age ≥18 years. Key exclusion criterion was an acute reinfection with SARS-CoV-2. Study site visits included standardised interviews, in-depth examination, and biomaterial procurement. In sub-cohort Kiel-I, a PCS (severity) score was developed based upon 12 long-term symptom complexes. Two validation sub-cohorts (Würzburg/Berlin, Kiel-II) were used for PCS score replication and identification of clinically meaningful predictors. This study is registered at clinicaltrials.gov (NCT04679584) and at the German Registry for Clinical Studies (DRKS, DRKS00023742). Findings: In Kiel-I (n = 667, 57% women), 90% of participants had received outpatient treatment for acute COVID-19. Neurological ailments (61·5%), fatigue (57·1%), and sleep disturbance (57·0%) were the most frequent persisting symptoms at 6-12 months after infection. Across sub-cohorts (Würzburg/Berlin, n = 316, 52% women; Kiel-II, n = 459, 56% women), higher PCS scores were associated with lower health-related quality of life (EQ-5D-5L-VAS/-index: r = -0·54/ -0·56, all p < 0·0001). Severe, moderate, and mild/no PCS according to the individual participant's PCS score occurred in 18·8%, 48·2%, and 32·9%, respectively, of the Kiel-I sub-cohort. In both validation sub-cohorts, statistically significant predictors of the PCS score included the intensity of acute phase symptoms and the level of personal resilience. Interpretation: PCS severity can be quantified by an easy-to-use symptom-based score reflecting acute phase disease burden and general psychological predisposition. The PCS score thus holds promise to facilitate the clinical diagnosis of PCS, scientific studies of its natural course, and the development of therapeutic interventions. Funding: The COVIDOM study is funded by the Network University Medicine (NUM) as part of the National Pandemic Cohort Network (NAPKON).

Outcome after surgical embolectomy for acute pulmonary embolism.

AIMS: Patients with pulmonary embolism (PE) and contraindications for or failed thrombolysis are at the highest risk for PE-related fatal events. These patients may benefit from surgical embolectomy, but data concerning this approach are still limited. METHODS: The method used here was retrospective data analysis of 103 patients who underwent surgical embolectomy from 2002 to 2020 at our department. RESULTS: Mean age was 58.4 (±15.1) years. Fifty-eight (56.3%) patients had undergone recent surgery; the surgery was tumor associated in 32 (31.1%) cases. Thirty (29.1%) patients had to be resuscitated due to PE, and 13 (12.6%) patients underwent thrombolysis prior to pulmonary embolectomy. Fifteen (14.5%) patients were placed on extra corporeal membrane oxygenation (ECMO) peri-operatively. Five patients (4.9%) died intra-operatively. Neurological symptoms occurred in four patients (3.9%). Thirty-day mortality was 23.3% ( n  = 24). Re-thoracotomy due to bleeding was necessary in 12 (11.6%) patients. This parameter was also identified as an independent risk factor for mortality. CONCLUSION: Surgical pulmonary embolectomy resulted in survival of the majority of patients with PE and contraindications for or failed thrombolysis. Given the excessive mortality when left untreated, an operative approach should become a routine part of discussions concerning alternative treatment options for these patients.

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

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

Analysis of the Seasonal Fluctuation of γδ T Cells and Its Potential Relation with Vitamin D3.

In addition to its role in bone metabolism, vitamin D3 exerts immunomodulatory effects and has been proposed to contribute to seasonal variation of immune cells. This might be linked to higher vitamin D3 levels in summer than in winter due to differential sun exposure. γδ T cells comprise a numerically small subset of T cells in the blood, which contribute to anti-infective and antitumor immunity. We studied the seasonal fluctuation of γδ T cells, the possible influence of vitamin D3, and the effect of the active metabolite 1α,25(OH)2D3 on the in vitro activation of human γδ T cells. In a retrospective analysis with 2625 samples of random blood donors, we observed higher proportions of γδ T cells in winter when compared with summer. In a prospective study over one year with a small cohort of healthy adults who did or did not take oral vitamin D3 supplementation, higher proportions of γδ T cells were present in donors without oral vitamin D3 uptake, particularly in spring. However, γδ T cell frequency in blood did not directly correlate with serum levels of 25(OH)D3. The active metabolite 1α,25(OH)2D3 inhibited the in vitro activation of γδ T cells at the level of proliferation, cytotoxicity, and interferon-γ production. Our study reveals novel insights into the seasonal fluctuation of γδ T cells and the immunomodulatory effects of vitamin D3.

Evaluation of prevention behaviour and its influencing factors with respect to cancer screening.

PURPOSE: Every year, about 4.6 million people are diagnosed with cancer in Europe. However, based on preclinical changes and using appropriate examination procedures certain cancers can be detected in symptom-free patients at an early stage and treatment initiated. In Germany, various cancer screening examinations are currently offered to the relevant age groups and sexes free of charge. Participation rates are affected by a number of factors and barriers. The study aimed at identifying potential obstacles and barriers to uptake, taking into account demographic and socio-economic variables. MATERIALS AND METHODS: Data collection was conducted in the context of routine examination appointments at the City of Kiel Occupational Health Department from September 2013 to September 2014 using an anonymised questionnaire. In addition to recording socio-demographic data and tobacco consumption, the questionnaire also catalogued participation in statutory health insurance cancer screening examinations using the "stages of change" from the Transtheoretical Model. Eight potential barriers to participation were recorded. RESULTS: The results are based on 718 completed questionnaires. It was found that women, older age, and non-smoking status were associated with a higher probability of participating in cancer screening. It was also found that various barriers affecting (regular) participation were perceived significantly different according to the individual stages of change. This influence of the stages was moderated by gender. CONCLUSION: The results showed interesting trends in the different barriers and how they are influenced by socioeconomic factors and the stages of change. Especially the stages require different gender-specific approaches to mobilisation for cancer screening.

Delirium on stroke units: a prospective, multicentric quality-improvement project.

BACKGROUND: Post-stroke delirium (POD) in patients on stroke units (SU) is associated with an increased risk for complications and poorer clinical outcome. The objective was to reduce the severity of POD by implementing an interprofessional delirium-management. METHODS: Multicentric quality-improvement project on five SU implementing a delirium-management with pre/post-comparison. Primary outcome was severity of POD, assessed with the Nursing Delirium Screening Scale (Nu-DESC). Secondary outcome parameters were POD incidence, duration, modified Rankin Scale (mRS), length of stay in SU and hospital, mortality, and others. RESULTS: Out of a total of 799 patients, 59.4% (n = 475) could be included with 9.5% (n = 45) being delirious. Implementation of a delirium-management led to reduced POD severity; Nu-DESC median: pre: 3.5 (interquartile range 2.6-4.7) vs. post 3.0 (2.2-4.0), albeit not significant (p = 0.154). Other outcome parameters were not meaningful different. In the post-period, delirium-management could be delivered to 75% (n = 18) of delirious patients, and only 24 (53.3%) of delirious patients required pharmacological treatments. Patients with a more severe stroke and POD remained on their disability levels, compared to similar affected, non-delirious patients who improved. CONCLUSIONS: Implementation of delirium-management on SU is feasible and can be delivered to most patients, but with limited effects. Nursing interventions as first choice could be delivered to the majority of patients, and only the half required pharmacological treatments. Delirium-management may lead to reduced severity of POD but had only partial effects on duration of POD or length of stay. POD hampers rehabilitation, especially in patients with more severe stroke. REGISTRY: DRKS, DRKS00021436. Registered 04/17/2020, www.drks.de/DRKS00021436 .

New-onset refractory status epilepticus (NORSE) and febrile infection-related epilepsy syndrome (FIRES) of unknown aetiology: A comparison of the incomparable?

PURPOSE: The discussion is ongoing whether new-onset refractory status epilepticus (NORSE) in adults and febrile infection-related epilepsy syndrome (FIRES) in children are one syndrome if the aetiology is unknown. In this study we will compare an adult cohort with NORSE and a paediatric cohort with FIRES in order to determine if they are similar or different. METHODS: We retrospectively compared 18 adults with NORSE versus 48 children with FIRES, both cohorts without identifiable cause despite extensive investigations. We analyzed demographic and clinical data using Mann-Whitney-U and χ2- tests. RESULTS: NORSE affected more women (78% vs. 42%; P = 0.009) than in FIRES. Median acute hospital stay was longer in FIRES (35 days [interquartile range, IQR=36] vs. 20 days [IQR=19]; P<0.001). FIRES was treated more frequently with coma therapy (82% vs. 28%; P<0.001) and with a higher median number of antiseizure medicines (7 [IQR=5] vs. 4 [IQR=2]; P<0.001). Children with FIRES showed a higher cerebrospinal fluid (CSF) cell count (10 cells/µl; P = 0.002) but a lower CSF protein level than adults with NORSE (48 mg/dl; P = 0.028). Immunotherapy was administered more frequently in FIRES (73% vs. 22%; P<0.001) than in NORSE. Group differences in number of antiseizure medicines after hospital stay (P = 0.229) and in overall mortality (P = 0.327) were not significant. CONCLUSION: In our explorative comparison, differences prevailed. NORSE and FIRES should be compared prospectively in age-matched cohorts.

Experimental Evaluation of the Effectiveness of Aspiration-Based Techniques to Treat Different Types of Acute Thromboembolic Occlusions in the Femoropopliteal Vascular System Using an In Vitro Flow Model.

PURPOSE: In this in vitro study, the effectiveness and safety of four aspiration-based techniques for thrombectomy are evaluated for three types of thrombi in a flow model simulating the femoropopliteal segment. MATERIAL AND METHODS: Red, white, and mixed thrombi were produced in a standardized manner and used to simulate occlusion of a superficial femoral artery using a pulsatile flow model. Four techniques were compared: aspiration alone, aspiration + stent retriever, exposing thrombus to laser by an excimer laser system and a laser catheter + aspiration, and aspiration + mechanical fragmentation by a separator. Rate of first-pass recanalization, embolic events, and number of embolized fragments > 1 mm were compared. RESULTS: Aspiration alone, stent retriever, laser, and separator differed in rates of first-pass recanalization (53.3%; 86.6%; 20%; and 100%) and embolic events (40%; 93.3%; 73.3%; and 60%). Number of embolized fragments was lowest with aspiration and higher with separator, laser, and stent retriever. Rates of first-pass-recanalization (75%; 75%; and 45%) and embolic events (65%; 60%; and 75%) differed for red, white, and mixed thrombi. The mixed thrombus caused the highest number of embolized fragments, which was particularly high using the stent retriever. CONCLUSION: Additional use of mechanical techniques significantly enhances the effectiveness of thrombectomy but simultaneously provokes more embolism. Laser seems to negatively alter the structure of a thrombus and thus diminishes the effectiveness, while provoking embolism. All techniques had lowest effectiveness, but highest embolism with the mixed thrombus. This was particularly striking when a stent retriever was used with the mixed thrombus.

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.

Clinical Priority Setting and Decision-Making in Sweden: A Cross-sectional Survey Among Physicians.

BACKGROUND: Priority setting in healthcare that aims to achieve a fair and efficient allocation of limited resources is a worldwide challenge. Sweden has developed a sophisticated approach. Still, there is a need for a more detailed insight on how measures permeate clinical life. This study aimed to assess physicians' views regarding (1) impact of scarce resources on patient care, (2) clinical decision-making, and (3) the ethical platform and national guidelines for healthcare by the National Board of Health and Welfare (NBHW). METHODS: An online cross-sectional questionnaire was sent to two groups in Sweden, 2016 and 2017. Group 1 represented 331 physicians from different departments at one University hospital and group 2 consisted of 923 members of the Society of Cardiology. RESULTS: Overall, a 26% (328/1254) response rate was achieved, 49% in group 1 (162/331), 18% in group 2 (166/923). Scarcity of resources was perceived by 59% more often than 'at least once per month,' whilst 60% felt less than 'well-prepared' to address this issue. Guidelines in general had a lot of influence and 19% perceived them as limiting decision-making. 86% professed to be mostly independent in decision-making. 36% knew the ethical platform 'well' and 'very well' and 64% NBHW's national guidelines. 57% expressed a wish for further knowledge and training regarding the ethical platform and 51% for support in applying NBHW's national guidelines. CONCLUSION: There was a need for more support to deal with scarcity of resources and for increased knowledge about the ethical platform and NBHW's national guidelines. Independence in clinical decision-making was perceived as high and guidelines in general as important. Priority setting as one potential pathway to fair and transparent decision-making should be highlighted more in Swedish clinical settings, with special emphasis on the ethical platform.

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.

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.

Multichannel anodal tDCS over the left dorsolateral prefrontal cortex in a paediatric population.

Methodological studies investigating transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex (lDLPFC) in paediatric populations are limited. Therefore, we investigated in a paediatric population whether stimulation success of multichannel tDCS over the lDLPFC depends on concurrent task performance and individual head anatomy. In a randomised, sham-controlled, double-blind crossover study 22 healthy participants (10-17 years) received 2 mA multichannel anodal tDCS (atDCS) over the lDLPFC with and without a 2-back working memory (WM) task. After stimulation, the 2-back task and a Flanker task were performed. Resting state and task-related EEG were recorded. In 16 participants we calculated the individual electric field (E-field) distribution. Performance and neurophysiological activity in the 2-back task were not affected by atDCS. atDCS reduced reaction times in the Flanker task, independent of whether atDCS had been combined with the 2-back task. Flanker task related beta oscillation increased following stimulation without 2-back task performance. atDCS effects were not correlated with the E-field. We found no effect of multichannel atDCS over the lDLPFC on WM in children/adolescents but a transfer effect on interference control. While this effect on behaviour was independent of concurrent task performance, neurophysiological activity might be more sensitive to cognitive activation during stimulation. However, our results are limited by the small sample size, the lack of an active control group and variations in WM performance.