Effects of the "ICU Support" team meeting concept on patient-centered and staff-centered outcomes: study protocol for a randomized controlled multicenter study.

BACKGROUND: Providing optimal care for critically ill patients is an extremely important but also highly demanding task, both emotionally and physically. The "ICU Support" team meeting concept aims to support intensive care unit (ICU) teams by promoting interprofessional communication, peer support, and patient safety by providing a structure for daily team meetings. This protocol describes a study to explore the effectiveness of "ICU Support" for patient- and staff-centered outcomes. METHODS: ICU Support will be implemented at nine university hospitals located in Germany, following a two-arm randomized parallel group design with an intervention and a control condition and three data collection periods. In the intervention arm, leading ICU personnel (physicians and nurses) will be trained in ICU Support and implement the ICU Support elements into the daily work routine of their units upon completion of data collection period T0 (baseline). In the control arm, ICU Support will not be implemented until the completion of the data collection period T1 (1 month after study start). Until then, the regular daily schedule of the ICU teams will be maintained. The final data collection period (T2) will take place 4 months after the start of the study. Primary outcomes include the number of intensive care complications per patient during their ICU stay during T1 and the sick-related absence of ICU staff during T1. Secondary outcomes include, among others, the average severity of intensive care complications per patient and employee self-reported data regarding their teamwork and patient safety behaviors. DISCUSSION: The need for healthy and well-trained ICU staff is omnipresent; thus, structured and evidence-based interventions aimed at supporting ICU teams and facilitating patient safety are required. This multicenter study aims to explore the effectiveness of ICU Support for patient- and staff-centered outcomes. The insights derived from this study have the potential to significantly improve ICU patient safety, staff communication, and connectedness and decrease sickness-related expenses and social costs associated with high work demands among ICU staff. TRIAL REGISTRATION: German Clinical Trials Register DRKS00028642 . Registered on 4 April 2022.

[Transition from intensive care to palliative care : A retrospective analysis of 102 consultation requests]. / Transition von der Intensivmedizin zur Palliativmedizin : Eine retrospektive Analyse von 102 Konsilanforderungen.

BACKGROUND: The transition of patients from the intensive care unit (ICU) to the palliative care (PC) ward often implies changes including establishing a palliative concept. Adaptation of therapeutic goals can be challenging for medical staff, patients and relatives; however, descriptions of these transition trajectories are rare. OBJECTIVE: The aim of this retrospective study was to characterize the consultation requests of the ICU to the PC consultation team as well as the patients by a description of trajectories and interventions. METHODS: Retrospective analysis of all patients receiving intensive care at RWTH Aachen University Hospital in 2019 for whom a PC consultation was requested. The patient population transferred from the ICU to the PC ward was compared with the non-transferred population. In each case, the primary consultation was evaluated regarding the following factors: question, vigilance, length of time from consultation request to its performance, and primary focus of the question. The question focus was categorized into "symptom control", "counselling" and "transfer" (tick options). In addition, a free text field was available for further notes. Exploration of diagnoses was complemented by accessing the electronic health records. RESULTS: A total of 102 consultation requests from the ICU to the PC ward were evaluated. The morbidity of patients was high, and most patients had at least one of the following diagnoses: pulmonary (62%), cardiovascular (61%), and/or neurological disease (55%). Of the patients 32 (31%) were transferred to the PC ward, among whom weakness (94%), fatigue (77%), anxiety (55%), pain (53%), and dyspnea (48%) were the most frequently noted symptoms. Of the transferred patients 5 (16%) could be discharged to home, nursing home, hospice or other. In total, 35 (34%) of all patients who were seen by palliative care specialists on ICUs in 2019 could be discharged alive. The most frequent reasons for nonadmission were lack of capacity of the PC ward (33%), dying while being on the waiting list (20%), and refusal by the patient (20%). Of the patients, 7 (26%) died within 48 h after they had been transferred to the PC ward. Performed consultation services "symptom control" (χ2 = 10.17; p < 0.05) and "counselling" (χ2 = 12.82; p < 0.001), which were requested by the intensive care physicians, showed a significant linkage with the respective intervention performed by the palliative care team. On the other hand, no statistically significant difference was found for requested and performed "transfer" of patients from ICUs to PC ward. Comparing the transferred versus non-transferred patient population, a significantly more frequent transfer of patients with malignant tumors (p = 0.00) was observed. CONCLUSION: The need for palliative care support in the ICUs exceeded the admission capacity of the PC ward. Future studies should further examine palliative care models in intensive care medicine.

Reflective practice improves Basic Life Support training outcomes: A randomized controlled study.

INTRODUCTION: Practical skills training is an essential part of medical education. An important example is the training of Basic Life Support (BLS) skills, which are key to improve patient outcomes in life-threatening situations. However, despite practical training, BLS performance is often sub-optimal even among healthcare professionals and medical students. Finding more effective training methods is therefore of high importance. A promising method to enhance learning outcomes is reflective practice. The goal of the present study was to evaluate whether a short reflective practice intervention following standard BLS training (Peyton's 4-step approach) improves BLS training outcomes, reflected in higher BLS performance and higher self-confidence to perform BLS. METHOD: 287 first-year medical students were randomly assigned to one of two BLS training conditions: 1) standard BLS training (ST), 2) ST followed by a 15-minute reflective practice exercise. Outcome parameters included objective BLS performance data assessed by a resuscitation manikin, and students' self-reported confidence in their BLS skills. Outcomes were assessed directly after the training (T0) and re-assessed one week later (T1). A two-way mixed model analysis of variance (ANOVA) was conducted to examine the effect of the intervention on BLS performance and self-reported confidence. Significance was determined by two-sided 95% confidence intervals. RESULTS: The intervention group performed significantly more effective compressions at T1 and began significantly faster with performing their first chest compression at T0 and T1, in comparison to the control group. No significant differences between study groups regarding their self-reported confidence to perform BLS were observed. CONCLUSION: This research shows that standard BLS training accompanied with a simple, cost-effective reflective practice exercise can improve learners' BLS skill acquisition and retention. This shows that reflective practice has the potential to enhance practical skills training in medicine; yet, more empirical studies are needed to examine its broader applicability.

[Application of artificial intelligence systems in the emergency room : Do the communication patterns give indications for possible starting points? An observational study]. / Anwendung von Systemen der künstlichen Intelligenz im Schockraum : Geben die Kommunikationsmuster Hinweise auf mögliche Ansatzpunkte? Eine Beobachtungsstudie.

BACKGROUND: High expectations are currently attached to the application of artificial intelligence (AI) in the resuscitation room treatment of trauma patients with respect to the development of decision support systems. No data are available regarding possible starting points for AI-controlled interventions in resuscitation room treatment. OBJECTIVE: Do information request behavior and quality of communication indicate possible starting points for AI applications in the emergency room? MATERIAL AND METHODS: A 2­stage qualitative observational study: 1. Development of an observation sheet based on expert interviews that depicts the following six relevant topics: situational factors (course of accident, environment), vital parameters, treatment-specific Information (treatment carried out). trauma-specific factors (injury patterns), medication, special features of the patient (anamnesis, etc.) 2. Observational study Which topics were inquired about during emergency room treatment? Was the exchange of information complete? RESULTS: There were 40 consecutive observations in the emergency room. A total of 130 questions: 57/130 inquiries about medication/treatment-specific Information and vital parameters, 19/28 of which were inquiries about medication. Questions about injury-related parameters 31/130 with 18/31 regarding injury patterns, course of accident (8/31) and type of accident (5/31). Questions about medical or demographic background 42/130. Within this group, pre-existing illnesses (14/42) and demographic background (10/42) were the most frequently asked questions. Incomplete exchange of information was found in all six subject areas. CONCLUSION: Questioning behavior and incomplete communication indicate a cognitive overload. Assistance systems that prevent cognitive overload can maintain decision-making abilities and communication skills. Which AI methods can be used requires further research.

Safety management in times of crisis: Lessons learned from a nationwide status-analysis on German intensive care units during the COVID-19 pandemic.

Background: The status of Safety Management is highly relevant to evaluate an organization's ability to deal with unexpected events or errors, especially in times of crisis. However, it remains unclear to what extent Safety Management was developed and sufficiently implemented within the healthcare system during the COVID-19 pandemic. Providing insights of potential for improvement is expected to be directional for ongoing Safety Management efforts, in times of crisis and beyond. Method: A nationwide survey study was conducted among healthcare professionals and auxiliary staff on German Intensive Care Units (ICUs) evaluating their experiences during the first wave of the COVID-19 pandemic. Error Management and Patient Safety Culture (PSC) measures served to operationalize Safety Management. Data were analyzed descriptively and by using quantitative content analysis (QCA). Results: Results for n = 588 participants from 53 hospitals show that there is a gap between errors occurred, reported, documented, and addressed. QCA revealed that low quality of safety culture (27.8%) was the most mentioned reason for errors not being addressed. Overall, ratings of PSC ranged from 26.7 to 57.9% positive response with Staffing being the worst and Teamwork Within Units being the best rated dimension. While assessments showed a similar pattern, medical staff rated PSC on ICUs more positively in comparison to nursing staff. Conclusion: The status-analysis of Safety Management in times of crisis revealed relevant potential for improvement. Human Factor plays a crucial role in the occurrence and the way errors are dealt with on ICUs, but systemic factors should not be underestimated. Further intensified efforts specifically in the fields of staffing and error reporting, documentation and communication are needed to improve Safety Management on ICUs. These findings might also be applicable across nations and sectors beyond the medical field.

Telemedicine in medical education: An example of a digital preparatory course for the clinical traineeship - a pre-post comparison.

Introduction: Telemedicine is a significant component of healthcare in most disciplines, giving great importance to the education of young physicians in this field. However, the topic of telemedicine has not yet been implemented in medical schools' curricula. This paper makes an important contribution to closing this gap by designing, implementing and evaluating a course with telemedical components. Using the example of a clinical traineeship preparation course, we investigated the extent to which integrated telemedical modules can contribute to the subjective confidence of students with regard to knowledge and confidence in performing practical telemedical skills, such as doctor-patient communication, taking medical histories, and applying handover techniques. Project description: The course evaluation was descriptive. Subjective confidence in clinical telemedicine skills was assessed before and after completion of the course using an online questionnaire and calculated in a pre-post design using Wilcoxon's signed-rank test. Results: The course was rated "very good" (31%) and "good" (54.2%) by the vast majority of students. The results of the Wilcoxon test show significant increases in students' feelings of confidence in performing practical telemedicine skills for all items. Discussion: This study shows that telemedicine modules integrated in a digital preparatory course contribute positively to students' subjective confidence in terms of knowledge and confidence in performing practical telemedicine skills. Specifically, this paper illustrates that professional digital doctor-patient communication, digital documentation of a medical history, and handoff techniques can be learned through telemedicine course content. Conclusion: Telemedicine modules increase students' subjective confidence in performing practical telemedicine skills. Practical telemedicine course content can thus reduce uncertainty in the use of telemedicine and prepare future physicians for its use.

At the limits of digital education. The importance of practical education for clinical competencies learning in the field of emergency medicine: A controlled non-randomized interventional study.

Introduction: A high-quality education of future physicians is essential. Modern approaches interlock the acquisition of theoretical knowledge and practical skills in a spiral curriculum, leading to a mutual learning benefit for knowledge and application. This model was challenged by the elimination of hands-on trainings during the pandemic, which were often replaced by purely digital teaching models. Given the holistic nature of the spiral curriculum, we assumed that a purely digital model would have an impact on knowledge acquisition due to missing hands-on learning opportunities. The aim of the study was to investigate, using an emergency seminar as an example, whether purely digital training leads to a difference in theoretical knowledge compared to the traditional model. Materials and methods: Study design: We used a two-groups design comparing a sample of medical students taught in 2020 with a purely digital teaching format (DF; n = 152) with a historical control group taught with a traditional format (TF; n = 1060). Subject of investigation was a seminar on emergency medicine, taking place in the 4th year. Outcome parameters: The primary outcome parameter was the students' acquired knowledge, measured by the score achieved in the final exams. Students' evaluation of the seminar was used as a secondary outcome parameter. Results: Students in the DF group scored significantly lower than students in the TF group in the final exams. Students in the DF group rated the course significantly worse than students in the TF group. Discussion: The study results illustrate that purely digital education leads to inferior knowledge acquisition compared to the traditional spiral curriculum. A possible explanation may lie in a deeper processing of the information (e.g., understanding the information by experience and analysis) and accordingly a better memory recall. Moreover, the students' critical appraisal of the DF may have had an unfavorable effect on learning performance. Moderating factors may be lower learning motivation or the "zoom fatigue" effect. Conclusion: These study results clearly illustrate the importance of hands-on teaching for knowledge acquisition. The interlocking of theoretical knowledge and practical skills, as ensured by the spiral curriculum, is essential.

Innovative Tele-Instruction Approach Impacts Basic Life Support Performance: A Non-inferiority Trial.

Background: Sustaining Basic Life Support (BLS) training during the COVID-19 pandemic bears substantial challenges. The limited availability of highly qualified instructors and tight economic conditions complicates the delivery of these life-saving trainings. Consequently, innovative and resource-efficient approaches are needed to minimize or eliminate contagion while maintaining high training standards and managing learner anxiety related to infection risk. Methods: In a non-inferiority trial 346 first-year medical, dentistry, and physiotherapy students underwent BLS training at AIXTRA-Competence Center for Training and Patient Safety at the University Hospital RWTH Aachen. Our objectives were (1) to examine whether peer feedback BLS training supported by tele-instructors matches the learning performance of standard instructor-guided BLS training for laypersons; and (2) to minimize infection risk during BLS training. Therefore, in a parallel group design, we compared arm (1) Standard Instructor Feedback (SIF) BLS training (Historical control group of 2019) with arm (2) a Tele-Instructor Supported Peer-Feedback (TPF) BLS training (Intervention group of 2020). Both study arms were based on Peyton's 4-step approach. Before and after each training session, objective data for BLS performance (compression depth and rate) were recorded using a resuscitation manikin. We also assessed overall BLS performance via standardized instructor evaluation and student self-reports of confidence via questionnaire. Non-inferiority margins for the outcome parameters and sample size calculation were based on previous studies with SIF. Two-sided 95% confidence intervals were employed to determine significance of non-inferiority. Results: The results confirmed non-inferiority of TPF to SIF for all tested outcome parameters. A follow-up after 2 weeks found no confirmed COVID-19 infections among the participants. Conclusion: Tele-instructor supported peer feedback is a powerful alternative to in-person instructor feedback on BLS skills during a pandemic, where infection risk needs to be minimized while maximizing the quality of BLS skill learning. Trial registration: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00025199, Trial ID: DRKS00025199.

Are the World Health Organization's Patient Safety Learning Objectives Still Up-to-Date: A Group Concept Mapping Study.

BACKGROUND: The World Health Organization (WHO) Patient Safety Curriculum Guide defines learning objectives for patient safety. Current implementation in healthcare education is insufficient. Possible explanations may be obsolescence and/or a shift in needs. We investigated whether overarching topics and specific learning objectives of the WHO Patient Safety Curriculum Guide are still up-to-date, their attributed importance, and their perceived difficulty to achieve. METHODS: Experts on patient safety and medical education from 3 European countries were asked to suggest learning objectives concerning patient safety using group concept mapping. Following 3 successive steps, experts rated ideas by importance and difficulty to achieve. Correlation analyses investigated the relationship between those. Overarching topics of the learning goals (clusters) were identified with multivariate analysis. RESULTS: A total of 119 statements about intended learning objectives on patient safety were generated, of which 86 remained for sorting and rating. Based on multivariate analyses, 10 overarching topics (clusters) emerged. Both the learning objectives and the overarching topics showed high correspondence with the WHO Patient Safety Curriculum Guide. Strong correlations emerged between importance and difficulty ratings for learning objectives and overarching topics. CONCLUSIONS: The WHO Patient Safety Curriculum Guide's learning goals are still relevant and up-to-date. Remarkably, learning objectives categorized as highly important are also perceived as difficult to achieve. In summary, the insufficient implementation in medical curricula cannot be attributed to the content of the learning goals. The future focus should be on how the WHO learning goals can be implemented in existing curricular courses.

Video-Assisted Peer Teaching for Surgical Skills Training - Innovative Potential for the Medical Curriculum and Beyond: A Randomized Controlled Trial.

OBJECTIVE: Hygienic healthcare standards are essential for avoiding hospital infections. However, medical students and staff lack training in this field, which may be due to high personnel resources of present educational approaches. Thus, there is an urgent need for a novel and efficient approach. Aim of the study is to compare a newly developed video-assisted peer feedback (VAPF) method for teaching wound dressings to the traditional teaching method with qualified instructor feedback (QIF) with respect to essential learning outcomes. DESIGN, SETTING AND PARTICIPANTS: In this randomized controlled noninferiority trial, 251 medical undergraduates were randomly assigned to one of two interventions (QIF n = 127; VAPF n = 124). In QIF, participants received feedback from a qualified instructor. In VAPF, participants video-recorded each other while performing a wound dressing and gave each other feedback assisted by a standardized checklist. Outcome measures were participants' score in an objective structured practical examination (OSPE) and a written exam after the course. RESULTS: Noninferiority of VAPF (n = 123) compared to QIF (n = 127) was confirmed for both OSPE (QIF: 8.83 ± 1.30; VAPF: 8.88 ± 1.04; mean difference -0.04, 95% CI -0.34 to 0.25) and written exam (QIF: 8.99 ± 1.06; VAPF: 9.14 ± 1.05; mean difference -0.15, 95% CI -0.41 to 0.12). CONCLUSIONS: VAPF is a cost-efficient and viable alternative to QIF commonly used in medical education. It provides comparable training outcomes to the traditional training method with lower personnel investment. VAPF is a promising educational method for improving essential clinical competencies.

[Medical students as helpers in the pandemic : Innovative concept for recruitment, training and assignment planning of medical students as medical personnel during the COVID-19 pandemic]. / Medizinstudierende als Helfende in der Pandemie : Innovatives Konzept zu Rekrutierung, Schulung und Einsatzplanung von Medizinstudierenden als medizinisches Personal während der COVID-19-Pandemie.

BACKGROUND: The COVID-19 pandemic posed enormous challenges to the German healthcare system and highlighted the need for strategies to recruit, train, and deploy medical personnel. Until now, no holistic concept existed to use medical students as support for professionals in intensive care units (ICU) to avoid staff shortages in medical care. METHOD: In a large-scale pilot project 265 medical students were trained for an ICU assignment. The innovative training module was accompanied by a pre-post questionnaire for self-assessment of the skills learned. 22 weeks after the training module and still during the pandemic deployment, another questionnaire was used to evaluate experiences in deployment and the efficiency of the training module with respect to preparation for ICU deployment. RESULTS: The analysis revealed significant mean differences for all COVID-19-specific variables (safety dimension) in favor of the training module (n = 168). The deployment evaluation showed that the training concept was inconsistently assessed as preparation for the work deployment for 69 of the 89 deployed students in total (53% agreement/47% disagreement). CONCLUSION: The results show a good feasibility of an innovative training concept for medical students with respect to a pandemic deployment as assistants in intensive care units. The concept is suitable for providing additional helpers in intensive care units during a pandemic; however, the inconsistent evaluation indicates that the concept can be expanded and needs to be adapted.

fMRI Neurofeedback-Enhanced Cognitive Reappraisal Training in Depression: A Double-Blind Comparison of Left and Right vlPFC Regulation.

Affective disorders are associated with maladaptive emotion regulation strategies. In particular, the left more than the right ventrolateral prefrontal cortex (vlPFC) may insufficiently regulate emotion processing, e.g., in the amygdala. A double-blind cross-over study investigated NF-supported cognitive reappraisal training in major depression (n = 42) and age- and gender-matched controls (n = 39). In a randomized order, participants trained to upregulate either the left or the right vlPFC during cognitive reappraisal of negative images on two separate days. We wanted to confirm regional specific NF effects with improved learning for left compared to right vlPFC (ClinicalTrials.gov NCT03183947). Brain responses and connectivity were studied with respect to training progress, gender, and clinical outcomes in a 4-week follow-up. Increase of vlPFC activity was stronger after NF training from the left- than the right-hemispheric ROI. This regional-specific NF effect during cognitive reappraisal was present across patients with depression and controls and supports a central role of the left vlPFC for cognitive reappraisal. Further, the activity in the left target region was associated with increased use of cognitive reappraisal strategies (r = 0.48). In the 4-week follow-up, 75% of patients with depression reported a successful application of learned strategies in everyday life and 55% a clinically meaningful symptom improvement suggesting clinical usability.

Peer video feedback builds basic life support skills: A randomized controlled non-inferiority trial.

INTRODUCTION: Training Basic Life Support saves lives. However, current BLS training approaches are time-consuming and costly. Alternative cost-efficient and effective training methods are highly needed. The present study evaluated whether a video-feedback supported peer-guided Basic Life Support training approach achieves similar practical performance as a standard instructor-guided training in laypersons. METHODS: In a randomized controlled non-inferiority trial, 288 first-year medical students were randomized to two study arms with different Basic Life Support training methods: 1) Standard Instructor Feedback (SIF) or 2) a Peer Video Feedback (PVF). Outcome parameters were objective data for Basic Life Support performance (compression depth and rate) from a resuscitation manikin with recording software as well as overall Basic Life Support performance and subjective confidence. Non-inferiority margins (Δ) for these outcome parameters and sample size calculation were based on previous studies with Standard Instructor Feedback. Two-sided 95% confidence intervals were employed to determine significance of non-inferiority. RESULTS: Results confirmed non-inferiority of Peer Video Feedback to Standard Instructor Feedback for compression depth (proportion difference PVF-SIF = 2.9%; 95% CI: -8.2% to 14.1%; Δ = -19%), overall Basic Life Support performance (proportion difference PVF-SIF = 6.7%; 95% CI: 0.0% to 14.3%; Δ = -27%) and subjective confidence for CPR performance (proportion difference PVF-SIF = -0.01; 95% CI: -0.18-0.17; Δ = -0.5) and emergency situations (proportion difference PVF-SIF = -0.02; 95% CI: -0.21-0.18; Δ = -0.5). Results for compression rate were inconclusive. DISCUSSION: Peer Video Feedback achieves comparable results as standard instructor-based training methods. It is an easy-to-apply and cost-efficient alternative to standard Basic Life Support training methods. To improve performance with respect to compression rate, additional implementation of a metronome is recommended.

Virtual Reality Tour to Reduce Perioperative Anxiety in an Operating Setting Before Anesthesia: Randomized Clinical Trial.

BACKGROUND: Perioperative anxiety is a major burden to patients undergoing surgeries with general anesthesia. OBJECTIVE: This study investigated whether a virtual operating room tour (VORT) before surgery can be used to ameliorate perioperative anxiety. METHODS: We employed a randomized parallel-group design with 2 study arms to compare VORT to the standard operation preparation procedure. The study included 84 patients. A validated inventory (state-trait operation anxiety-state) was used to assess perioperative state anxiety before (T1) and after (T2) surgery. In addition, trait operation anxiety was evaluated with an additional validated inventory (state-trait operation anxiety-trait). Moreover, user ratings on the usefulness of VORT were assessed with an evaluation questionnaire. Study arms were compared for perioperative state anxiety with two-tailed independent samples t tests. Subjective ratings were correlated with STOA-Trait values to investigate possible associations between perioperative anxiety with perceived usefulness. RESULTS: There were no significant differences in perioperative state anxiety between VORT and standard operation preparation procedures before and after the surgery. Nonetheless, patients' ratings of VORT overall were positive. The tour was perceived as useful and, therefore, showed acceptance for VR use. These ratings were unrelated to the degree of perioperative anxiety. CONCLUSIONS: The subjective benefit of VORT could not be explained by a reduction of perioperative anxiety. Instead, VORT appears to serve the need for information and reduce uncertainty. In addition, VORT is perceived as beneficial regardless of the age of the patients. Considering this effect and the manageable organizational and financial effort toward implementation, the general use of VORT can be recommended. TRIAL REGISTRATION: ClinicalTrials.gov NCT04579354; https://clinicaltrials.gov/ct2/show/NCT04579354.

Do Digital Handover Checklists Influence the Clinical Outcome Parameters of Intensive Care Unit Patients? A Randomized Controlled Pilot Study.

Background: Clinical handovers have been identified as high-risk situations for medical treatment errors. It has been shown that handover checklists lead to a reduced rate of medical errors and mortality. However, the influence of handover checklists on essential patient outcomes such as prevalence of sepsis, mortality, and length of hospitalization has not yet been investigated in a randomized controlled trial (RCT). Objectives: The aim of the present pilot study was to estimate the effect of two different handover checklists on the 48 h sepsis-related organ failure assessment (SOFA) score and the feasibility of a respective clinical RCT. Methods: Outcome parameters and feasibility were investigated implementing and comparing an intervention with a control checklist. Design: Single center two-armed cluster randomized prospective crossover pilot study. Setting: The study took place over three 1-month periods in an intensive care unit (ICU) setting at the University Hospital Aachen. Patients/Participants: Data from 1,882 patients on seven ICU wards were assessed, of which 1,038 were included in the analysis. Intervention: A digital standardized handover checklist (ISBAR3) was compared to a control checklist (VICUR). Main Outcome Measures: Primary outcome was the 2nd 24 h time window sepsis-related organ failure assessment (SOFA) score. Secondary outcomes were SOFA scores on the 3rd and 5th 24 h time window, mortality, reuptake, and length of stay; handover duration, degree of satisfaction, and compliance as feasibility-related outcomes. Results: Different sepsis scores were observed only for the 1st 24 h time window after admission to the ICU, with higher values for ISBAR3. With respect to the patient-centered outcomes, both checklists achieved similar results. Average handover duration was shorter for VICUR, whereas satisfaction and compliance were higher for ISBAR3. However, overall compliance was low (25.4% for ISBAR3 and 15.8% for VICUR). Conclusions: Based on the results, a stratified randomization procedure is recommended for following RCTs, in which medical treatment errors should also be investigated as an additional variable. The use of control checklists is discouraged due to lower acceptance and compliance among healthcare practitioners. Measures should be undertaken to increase compliance with the use of checklists. Clinical outcome parameters should be carefully selected. Trial Registration: ClinicalTrials.gov, Identifier [NCT03117088]. Registered April 14, 2017.

Demonstrating equivalence and non-inferiority of medical education concepts.

CONTEXT: In medical education, there are often several didactic methods for teaching and learning a specific medical skill. For educators, there are often pragmatic reasons to decide for one or another of them, such as costs, infrastructural requirements, time expenditure or qualification of the teacher. However, a central aspect to consider is the learning outcome: Does a new method achieve a similar learning success as an established standard method? To answer this question, we need an appropriate method to assess comparability of learning outcomes. METHODS: In this paper, we present two essential statistical concepts that can address the issue of comparability of learning outcomes: Equivalence and non-inferiority testing. We explain the ideas behind these concepts and illustrate them with an example data set. To clarify several concepts, we use theoretical examples from one selected field: the teaching and assessment of Basic Life Support (BLS). CONCLUSIONS: Equivalence and non-inferiority tests can be powerful tools for comparing teaching and assessment methods. However, their correct application requires adequate knowledge about their strengths, pitfalls and application fields. The aim of this paper is to deliver this knowledge and to provide clinician researchers with a practical guidance to a successful application of these methods.

Supramodal neural networks support top-down processing of social signals.

The perception of facial and vocal stimuli is driven by sensory input and cognitive top-down influences. Important top-down influences are attentional focus and supramodal social memory representations. The present study investigated the neural networks underlying these top-down processes and their role in social stimulus classification. In a neuroimaging study with 45 healthy participants, we employed a social adaptation of the Implicit Association Test. Attentional focus was modified via the classification task, which compared two domains of social perception (emotion and gender), using the exactly same stimulus set. Supramodal memory representations were addressed via congruency of the target categories for the classification of auditory and visual social stimuli (voices and faces). Functional magnetic resonance imaging identified attention-specific and supramodal networks. Emotion classification networks included bilateral anterior insula, pre-supplementary motor area, and right inferior frontal gyrus. They were pure attention-driven and independent from stimulus modality or congruency of the target concepts. No neural contribution of supramodal memory representations could be revealed for emotion classification. In contrast, gender classification relied on supramodal memory representations in rostral anterior cingulate and ventromedial prefrontal cortices. In summary, different domains of social perception involve different top-down processes which take place in clearly distinguishable neural networks.

A Novel Brain-Computer Interface Virtual Environment for Neurofeedback During Functional MRI.

Virtual environments (VEs), in the recent years, have become more prevalent in neuroscience. These VEs can offer great flexibility, replicability, and control over the presented stimuli in an immersive setting. With recent developments, it has become feasible to achieve higher-quality visuals and VEs at a reasonable investment. Our aim in this project was to develop and implement a novel real-time functional magnetic resonance imaging (rt-fMRI)-based neurofeedback (NF) training paradigm, taking into account new technological advances that allow us to integrate complex stimuli into a visually updated and engaging VE. We built upon and developed a first-person shooter in which the dynamic change of the VE was the feedback variable in the brain-computer interface (BCI). We designed a study to assess the feasibility of the BCI in creating an immersive VE for NF training. In a randomized single-blinded fMRI-based NF-training session, 24 participants were randomly allocated into one of two groups: active and reduced contingency NF. All participants completed three runs of the shooter-game VE lasting 10 min each. Brain activity in a supplementary motor area region of interest regulated the possible movement speed of the player's avatar and thus increased the reward probability. The gaming performance revealed that the participants were able to actively engage in game tasks and improve across sessions. All 24 participants reported being able to successfully employ NF strategies during the training while performing in-game tasks with significantly higher perceived NF control ratings in the NF group. Spectral analysis showed significant differential effects on brain activity between the groups. Connectivity analysis revealed significant differences, showing a lowered connectivity in the NF group compared to the reduced contingency-NF group. The self-assessment manikin ratings showed an increase in arousal in both groups but failed significance. Arousal has been linked to presence, or feelings of immersion, supporting the VE's objective. Long paradigms, such as NF in MRI settings, can lead to mental fatigue; therefore, VEs can help overcome such limitations. The rewarding achievements from gaming targets can lead to implicit learning of self-regulation and may broaden the scope of NF applications.

Rt-fMRI neurofeedback-guided cognitive reappraisal training modulates amygdala responsivity in posttraumatic stress disorder.

BACKGROUND: Traumatic experiences are associated with neurofunctional dysregulations in key regions of the emotion regulation circuits. In particular, amygdala responsivity to negative stimuli is exaggerated while engagement of prefrontal regulatory control regions is attenuated. Successful application of emotion regulation (ER) strategies may counteract this disbalance, however, application of learned strategies in daily life is hampered in individuals afflicted by posttraumatic stress disorder (PTSD). We hypothesized that a single session of real-time fMRI (rtfMRI) guided upregulation of prefrontal regions during an emotion regulation task enhances self-control during exposure to negative stimuli and facilitates transfer of the learned ER skills to daily life. METHODS: In a cross-over design, individuals with a PTSD diagnosis after a single traumatic event (n = 20) according to DSM-IV-TR criteria and individuals without a formal psychiatric diagnosis (n = 21) underwent a cognitive reappraisal training. In randomized order, all participants completed two rtfMRI neurofeedback (NF) runs targeting the left lateral prefrontal cortex (lPFC) and two control runs without NF (NoNF) while using cognitive reappraisal to reduce their emotional response to negative scenes. During the NoNF runs, two %%-signs were displayed instead of the two-digit feedback (FB) to achieve a comparable visual stimulation. The project aimed at defining the clinical potential of the training according to three success markers: (1) NF induced changes in left lateral prefrontal cortex and bilateral amygdala activity during the regulation of aversive scenes compared to cognitive reappraisal alone (primary registered outcome), (2) associated changes on the symptomatic and behavioral level such as indicated by PTSD symptom severity and affect ratings, (3) clinical utility such as indicated by perceived efficacy, acceptance, and transfer to daily life measured four weeks after the training. RESULTS: In comparison to the reappraisal without feedback, a neurofeedback-specific decrease in the left lateral PFC (d = 0.54) alongside an attenuation of amygdala responses (d = 0.33) emerged. Reduced amygdala responses during NF were associated with symptom improvement (r = -0.42) and less negative affect (r = -0.63) at follow-up. The difference in symptom scores exceeds requirements for a minimal clinically important difference and corresponds to a medium effect size (d = 0.64). Importantly, 75% of individuals with PTSD used the strategies in daily life during a one-month follow-up period and perceived the training as efficient. CONCLUSION: Our findings suggest beneficial effects of the NF training indicated by reduced amygdala responses that were associated with improved symptom severity and affective state four weeks after the NF training as well as patient-centered perceived control during the training, helpfulness and application of strategies in daily life. However, reduced prefrontal involvement was unexpected. The study suggests good tolerability of the training protocol and potential for clinical use in the treatment of PTSD.

Aberrant functional connectivity profiles of brain regions associated with salience and reward processing in female patients with borderline personality disorder.

Recent resting-state functional connectivity studies have shown significant group differences in several networks between patients suffering from borderline personality disorder (BPD) and healthy controls. However, reliable and consistent findings have not been reported yet. Several methodological factors might be responsible for the discrepant findings, including the heterogeneity of patient samples in terms of symptom severity. In the current study, we combined investigations of the whole-brain resting-state functional connectivity patterns of BPD patients with seed-based connectivity measures and then computed the correlation of connectivity measures with borderline symptom severity. Correlation-based connectivity analysis was performed on resting-state functional magnetic resonance imaging (fMRI) data from 26 female BPD patients and 26 healthy controls. Increased intrinsic connectivity was found in clusters involving part of the caudate nucleus and the left insula in the patient group, indicating greater integration of each region. Further seed-based connectivity analyses revealed that with the caudate seed, the patient data exhibited an increased resting-state functional connectivity in the bilateral ventral striatum and the midline prefrontal regions extending to the ACC, a network associated with reward processing. The left insula seed showed significantly increased connectivity with the bilateral fronto-orbital/insula, the inferior parietal lobule and the mid-cingulate cortex, a network involved in attention and salience encoding, in the patient population. Moreover, symptom severity, as assessed with the BSL-95 outside the scanner, was negatively correlated with the coupling of the insula and the striatum in the BPD group. Overall, an increased functional connectivity within two large-scale circuitries underlying reward and salience processing was evident in patients, as compared to healthy participants. When correlated with borderline symptom severity, a reduced connectivity between key regions belonging to the reward system and salience network was observed in the patients. These findings may be helpful for facilitating further understanding of the potential mechanisms underlying the BPD pathophysiology and thereby delineate potential treatment targets.