CytoSorb Rescue for COVID-19 Patients With Vasoplegic Shock and Multiple Organ Failure: A Prospective, Open-Label, Randomized Controlled Pilot Study.

OBJECTIVES: To investigate the effect of extracorporeal cytokine reduction by CytoSorb (CytoSorbents, Monmouth Junction, NJ) on COVID-19-associated vasoplegic shock. DESIGN: Prospective, randomized controlled pilot study. SETTING: Eight ICUs at three sites of the tertiary-care university hospital Charité-Universitätsmedizin Berlin. PATIENTS: COVID-19 patients with vasoplegic shock requiring norepinephrine greater than 0.2 µg/kg/min, C-reactive protein greater than 100 mg/L, and indication for hemodialysis. INTERVENTIONS: Randomization of 1:1 to receive CytoSorb for 3-7 days or standard therapy. To account for inadvertent removal of antibiotics, patients in the treatment group received an additional dose at each adsorber change. MEASUREMENTS AND MAIN RESULTS: The primary endpoint was time until resolution of vasoplegic shock, estimated by Cox-regression. Secondary endpoints included mortality, interleukin-6 concentrations, and catecholamine requirements. The study was registered in the German Registry of Clinical Trials (DRKS00021447). From November 2020 to March 2021, 50 patients were enrolled. Twenty-three patients were randomized to receive CytoSorb and 26 patients to receive standard of care. One patient randomized to cytokine adsorption was excluded due to withdrawal of informed consent. Resolution of vasoplegic shock was observed in 13 of 23 patients (56.5%) in the CytoSorb and 12 of 26 patients (46.2%) in the control group after a median of 5 days (interquartile range [IQR], 4-5 d) and 4 days (IQR, 3-5 d). The hazard ratio (HR) for the primary endpoint, adjusted for the predefined variables age, gender, extracorporeal membrane oxygenation-therapy, or time from shock onset to study inclusion was HR, 1.23 (95% CI, 0.54-2.79); p = 0.63. The mortality rate was 78% in the CytoSorb and 73% in the control group (unadjusted HR, 1.17 [95% CI, 0.61-2.23]; p = 0.64). The effects on inflammatory markers, catecholamine requirements, and the type and rates of adverse events were similar between the groups. CONCLUSIONS: In severely ill COVID-19 patients, CytoSorb did not improve resolution of vasoplegic shock or predefined secondary endpoints.

Differential diagnosis checklists reduce diagnostic error differentially: A randomised experiment.

INTRODUCTION: Wrong and missed diagnoses contribute substantially to medical error. Can a prompt to generate alternative diagnoses (prompt) or a differential diagnosis checklist (DDXC) increase diagnostic accuracy? How do these interventions affect the diagnostic process and self-monitoring? METHODS: Advanced medical students (N = 90) were randomly assigned to one of four conditions to complete six computer-based patient cases: group 1 (prompt) was instructed to write down all diagnoses they considered while acquiring diagnostic test results and to finally rank them. Groups 2 and 3 received the same instruction plus a list of 17 differential diagnoses for the chief complaint of the patient. For half of the cases, the DDXC contained the correct diagnosis (DDXC+), and for the other half, it did not (DDXC-; counterbalanced). Group 4 (control) was only instructed to indicate their final diagnosis. Mixed-effects models were used to analyse results. RESULTS: Students using a DDXC that contained the correct diagnosis had better diagnostic accuracy, mean (standard deviation), 0.75 (0.44), compared to controls without a checklist, 0.49 (0.50), P < 0.001, but those using a DDXC that did not contain the correct diagnosis did slightly worse, 0.43 (0.50), P = 0.602. The number and relevance of diagnostic tests acquired were not affected by condition, nor was self-monitoring. However, participants spent more time on a case in the DDXC-, 4:20 min (2:36), P ≤ 0.001, and DDXC+ condition, 3:52 min (2:09), than in the control condition, 2:59 min (1:44), P ≤ 0.001. DISCUSSION: Being provided a list of possible diagnoses improves diagnostic accuracy compared with a prompt to create a differential diagnosis list, if the provided list contains the correct diagnosis. However, being provided a diagnosis list without the correct diagnosis did not improve and might have slightly reduced diagnostic accuracy. Interventions neither affected information gathering nor self-monitoring.

Do different response formats affect how test takers approach a clinical reasoning task? An experimental study on antecedents of diagnostic accuracy using a constructed response and a selected response format.

The use of response formats in assessments of medical knowledge and clinical reasoning continues to be the focus of both research and debate. In this article, we report on an experimental study in which we address the question of how much list-type selected response formats and short-essay type constructed response formats are related to differences in how test takers approach clinical reasoning tasks. The design of this study was informed by a framework developed within cognitive psychology which stresses the importance of the interplay between two components of reasoning-self-monitoring and response inhibition-while solving a task or case. The results presented support the argument that different response formats are related to different processing behavior. Importantly, the pattern of how different factors are related to a correct response in both situations seem to be well in line with contemporary accounts of reasoning. Consequently, we argue that when designing assessments of clinical reasoning, it is crucial to tap into the different facets of this complex and important medical process.

A simulated night shift in the emergency room increases students' self-efficacy independent of role taking over during simulation.

BACKGROUND: Junior doctors do not feel well prepared when they start into postgraduate training. High self-efficacy however is linked to better clinical performance and may thus improve patient care. What factors affect self-efficacy is currently unknown. We conducted a simulated night shift in an emergency room (ER) with final-year medical students to identify factors contributing to their self-efficacy and thus inform simulation training in the ER. METHODS: We simulated a night in the ER using best educational practice including multi-source feedback, simulated patients and vicarious learning with 30 participants. Students underwent 7 prototypic cases in groups of 5 in different roles (leader, member and observer). Feeling of preparedness was measured at baseline and 5 days after the event. After every case students recorded their confidence dependent of their role during simulation and evaluated the case. RESULTS: Thirty students participated, 18 (60 %) completed all surveys. At baseline students feel unconfident (Mean -0.34). Feeling of preparedness increases significantly at follow up (Mean 0.66, p = 0.001, d = 1.86). Confidence after simulation is independent of the role during simulation (F(2,52) = 0.123, p = 0.884). Observers in a simulation can estimate leader's confidence independent of their own (r = 0.188, p = 0.32) while team members cannot (r = 0.61, p < 0.001). CONCLUSIONS: Simulation improves self-efficacy. The improvement of self-efficacy is independent of the role taken during simulation. As a consequence, groups can include observers as participants without impairing their increase in self-efficacy, providing a convenient way for educators to increase simulation efficiency. Different roles can furthermore be included into multi-source peer-feedback.

Effects of using a cognitive aid on content and feasibility of debriefings of simulated emergencies.

Background: Adverse events in patient care are often caused by failures in teamwork. Simulation training and its debriefing can contribute to improving teamwork and thus patient care. When conducting debriefings, there are several design factors that can potentially influence learning outcomes. This study examines the use of a cognitive aid to help structure the content of debriefings and compares it with debriefings that are merely roughly structured. In addition, the feasibility of the debriefing, the satisfaction of the participants and their teamwork during the training are investigated. Methods: In a simulated night shift, seven teams of four to five medical students (n=32) took part in six cases that simulated common situations in an emergency medicine environment and received a debriefing on their teamwork after each case, either in the intervention condition with the help of the TeamTAG tool - a cognitive aid focusing on selected teamwork principles from Crisis Resource Management (CRM) - or in the control condition without it. The facilitators noted the topics of the debriefings and rated their experience of conducting them; the participants indicated their satisfaction with the debriefings, as well as their assessment of the importance of CRM principles. In addition, the quality of teamwork was assessed using the Team Emergency Assessment Measure (TEAM). Results: The analysis showed no difference in the number of teamwork principles discussed between the control and intervention conditions, but topics were repeated more frequently in the control group. The TeamTAG guideline was focused on and implemented by the tutors, who discussed the CRM principles included in the TeamTAG more consistently than in the control condition. The tutors in both conditions were satisfied with the implementation, and the use of TeamTAG facilitated time management. There were no differences in participants' satisfaction, their assessment of the importance of the teamwork principles, or the quality of teamwork between conditions. Conclusion: The use of a cognitive aid can help to direct the focus on certain topics or learning objectives and facilitate time management through pre-structuring; however, a difference in learning outcomes (in terms of the quality of teamwork) could not be identified. Besides the influence of a certain structure or script, a strong influence from the individual guiding the debriefing is likely.

Rating the quality of teamwork-a comparison of novice and expert ratings using the Team Emergency Assessment Measure (TEAM) in simulated emergencies.

BACKGROUND: Training in teamwork behaviour improves technical resuscitation performance. However, its effect on patient outcome is less clear, partly because teamwork behaviour is difficult to measure. Furthermore, it is unknown who should evaluate it. In clinical practice, experts are obliged to participate in resuscitation efforts and are thus unavailable to assess teamwork quality. Consequently, we sought to determine if raters with little clinical experience and experts provide comparable evaluations of teamwork behaviour. METHODS: Novice and expert raters judged teamwork behaviour during 6 emergency medicine simulations using the Teamwork Emergency Assessment Measure (TEAM). Ratings of both groups were analysed descriptively and compared with U and t tests. We used a mixed effects model to identify the proportion of variance in TEAM scores attributable to rater status and other sources. RESULTS: Twelve raters evaluated 7 teams rotating through 6 cases, for a total of 84 observations. We found no significant difference between expert and novice ratings for 7 of the 11 items of the TEAM or in the sums of all item scores. Novices rated teamwork behaviour higher on 4 items and overall. Rater status accounted for 11.1% of the total variance in scores. CONCLUSIONS: Experts' and novices' ratings were similarly distributed, implying that raters with limited experience can provide reliable data on teamwork behaviour. Novices show a consistent, but slightly more lenient rating behaviour. Clinical studies and real-life teams may thus employ novices using a structured observational tool such as TEAM to inform their performance review and improvement.

Interprofessional Emergency Training Leads to Changes in the Workplace.

INTRODUCTION: Preventable mistakes occur frequently and can lead to patient harm and death. The emergency department (ED) is notoriously prone to such errors, and evidence suggests that improving teamwork is a key aspect to reduce the rate of error in acute care settings. Only a few strategies are in place to train team skills and communication in interprofessional situations. Our goal was to conceptualize, implement, and evaluate a training module for students of three professions involved in emergency care. The objective was to sensitize participants to barriers for their team skills and communication across professional borders. METHODS: We developed a longitudinal simulation-enhanced training format for interprofessional teams, consisting of final-year medical students, advanced trainees of emergency nursing and student paramedics. The training format consisted of several one-day training modules, which took place twice in 2016 and 2017. Each training module started with an introduction to share one's roles, professional self-concepts, common misconceptions, and communication barriers. Next, we conducted different simulated cases. Each case consisted of a prehospital section (for paramedics and medical students), a handover (everyone), and an ED section (medical students and emergency nurses). After each training module, we assessed participants' "Commitment to Change." In this questionnaire, students were anonymously asked to state up to three changes that they wished to implement as a result of the course, as well as the strength of their commitment to these changes. RESULTS: In total, 64 of 80 participants (80.0%) made at least one commitment to change after participating in the training modules. The total of 123 commitments was evenly distributed over four emerging categories: communication, behavior, knowledge and attitude. Roughly one third of behavior- and attitude-related commitments were directly related to interprofessional topics (e.g., "acknowledge other professions' work"), and these were equally distributed among professions. At the two-month follow-up, 32 participants (50%) provided written feedback on their original commitments: 57 of 62 (91.9%) commitments were at least partly realized at the follow-up, and only five (8.1%) commitments lacked realization entirely. CONCLUSION: A structured simulation-enhanced intervention was successful in promoting change to the practice of emergency care, while training teamwork and communication skills jointly.

Improving patient safety through better teamwork: how effective are different methods of simulation debriefing? Protocol for a pragmatic, prospective and randomised study.

INTRODUCTION: Medical errors have an incidence of 9% and may lead to worse patient outcome. Teamwork training has the capacity to significantly reduce medical errors and therefore improve patient outcome. One common framework for teamwork training is crisis resource management, adapted from aviation and usually trained in simulation settings. Debriefing after simulation is thought to be crucial to learning teamwork-related concepts and behaviours but it remains unclear how best to debrief these aspects. Furthermore, teamwork-training sessions and studies examining education effects on undergraduates are rare. The study aims to evaluate the effects of two teamwork-focused debriefings on team performance after an extensive medical student teamwork training. METHODS AND ANALYSES: A prospective experimental study has been designed to compare a well-established three-phase debriefing method (gather-analyse-summarise; the GAS method) to a newly developed and more structured debriefing approach that extends the GAS method with TeamTAG (teamwork techniques analysis grid). TeamTAG is a cognitive aid listing preselected teamwork principles and descriptions of behavioural anchors that serve as observable patterns of teamwork and is supposed to help structure teamwork-focused debriefing. Both debriefing methods will be tested during an emergency room teamwork-training simulation comprising six emergency medicine cases faced by 35 final-year medical students in teams of five. Teams will be randomised into the two debriefing conditions. Team performance during simulation and the number of principles discussed during debriefing will be evaluated. Learning opportunities, helpfulness and feasibility will be rated by participants and instructors. Analyses will include descriptive, inferential and explorative statistics. ETHICS AND DISSEMINATION: The study protocol was approved by the institutional office for data protection and the ethics committee of Charité Medical School Berlin and registered under EA2/172/16. All students will participate voluntarily and will sign an informed consent after receiving written and oral information about the study. Results will be published.

The future of practical skills in undergraduate medical education - an explorative Delphi-Study.

BACKGROUND: 64% of young medical professionals in Germany do not feel adequately prepared for the practical requirements of the medical profession. The goal of "outcome-orientated training" is to structure medical curricula based on the skills needed when entering the workforce after completing undergraduate medical education, and thus to bridge the gap between the skills graduates have attained and those necessary for a career in the medical profession. Outcome frameworks (OFs) are used for this purpose. In preparation for developing the National Competence-Based Catalogue of Learning Objectives for Medicine (NKLM) - the German OF - the "Consensus Statement of Practical Skills in Undergraduate Medical Education" (which structures the teaching and acquisition of practical skills in Germany and which strongly influenced the "Clinical-Practical Skills" chapter of the NKLM) was published in 2011. It is not uncommon for at least a decade to elapse between the definition and implementation of an OF and the students' graduation, which can further increase the gap between necessary and acquired skills. Thus, the purpose of this paper is to posit theses for future development in healthcare and to apply these theses to a current OF. METHODOLOGY: Partially structured interviews with experts were used to generate theses pertaining to general, future development in healthcare. These theses were assessed by physician experts based on the likelihood of implementation by the year 2025. The 288 learning goals of the consensus statement were assessed for their relevance for medical education in the interim. RESULTS: 11 theses were generated for the development of medicine, and these theses were assessed and discussed by 738 experts. These theses include the increase in diseases associated with old age, the increasing significance of interprofessional cooperation, and the growing prevalence of telemedicine applications. Of the 288 learning goals of the consensus statement, 231 of the goals were assessed as relevant, and 57 were deemed irrelevant for the short-term future. DISCUSSION: The theses on the future of healthcare, which were generated in this study and which were validated by numerous experts, provide indications of future developments of overall requirements for medical school graduates. For example, when applied to the content of the "Clinical-Practical Skills" NKLM chapter, they largely validate the future relevance of developing practical skills while also providing indications for their further development as applied to the consensus statement.