Incorporating patient centered benefits as endpoints in randomized trials of maintenance therapies in advanced ovarian cancer: A position paper from the GCIG symptom benefit committee.

BACKGROUND: Quality of life and patient reported outcome measures (PROMs) are important secondary endpoints and incorporated in most contemporary clinical trials. There have been deficiencies in their assessment and reporting in ovarian cancer clinical trials, particularly in trials of maintenance treatment where they are of particular importance. The Gynecologic Cancer InterGroup (GCIG) symptom benefit committee (SBC) recently convened a brainstorming meeting with representation from all collaborative groups to address questions of how to best incorporate PROMs into trials of maintenance therapies to support the primary endpoint which is usually progression free survival (PFS). These recommendations should harmonize the collection, analysis and reporting of PROM's across future GCIG trials. METHODS: Through literature review, trials analysis and input from international experts, the SBC identified four relevant topics to address with respect to promoting the role of PROMs to support the PFS endpoint in clinical trials of maintenance treatment for OC. RESULTS: The GCIG SBC unanimously accepted the importance of integrating PROM's in future maintenance trials and developed four guiding principles to be considered early in trial design. These include 1) adherence to SPIRIT-PRO guidelines, 2) harmonization of selection, collection and reporting of PROM's; 3) combining Health Related Quality of Life (HRQL) measures with clinical endpoints and 4) common approaches to dealing with incomplete HRQL data. CONCLUSIONS: Close attention to incorporating HRQL and PROM's is critical to interpret the results of ovarian cancer clinical trials of maintenance therapies. There should be a consistent approach to assessing and reporting patient centered benefits across all GCIG trials to enable cross trial comparisons which can be used to inform practice.

An Overview of the Allopathic Match.

The number of allopathic emergency medicine (EM) programs has been progressively increasing over the years. In 2018, allopathic EM postgraduate year-1 spots, compared with 2012, increased by around 60% to reach 2278 positions. EM is considered a competitive specialty and therefore, in this article we help guide students interested in EM through the allopathic match requirements, application process, interviews, and ranking EM programs. Additionally, we tackle the combined emergency medicine residency programs, namely the combined EM-Family Medicine (FM), EM-Anesthesiology, EM-Internal Medicine (IM), EM-IM-Critical Care Medicine, and EM-Pediatrics residency programs. Finally, we explain the increased likelihood of matching with the single graduate medical education accreditation system expected to happen in the year 2020.

Disaster Medicine: A Multi-Modality Curriculum Designed and Implemented for Emergency Medicine Residents.

OBJECTIVE: Few established curricula are available for teaching disaster medicine. We describe a comprehensive, multi-modality approach focused on simulation to teach disaster medicine to emergency medicine residents in a 3-year curriculum. METHODS: Residents underwent a 3-year disaster medicine curriculum incorporating a variety of venues, personnel, and roles. The curriculum included classroom lectures, tabletop exercises, virtual reality simulation, high-fidelity simulation, hospital disaster drills, and journal club discussion. All aspects were supervised by specialty emergency medicine faculty and followed a structured debriefing. Residents rated the high-fidelity simulations by using a 10-point Likert scale. RESULTS: Three classes of emergency medicine residents participated in the 3-year training program. Residents found the exercise to be realistic, educational, and relevant to their practice. After participating in the program, residents felt better prepared for future disasters. CONCLUSIONS: Given the large scope of impact that disasters potentiate, it is understandably difficult to teach these skills effectively. Training programs can utilize this simulation-based curriculum to better prepare the nation's emergency medicine physicians for future disasters. (Disaster Med Public Health Preparedness. 2016;10:611-614).

Training healthcare personnel for mass-casualty incidents in a virtual emergency department: VED II.

INTRODUCTION: Training emergency personnel on the clinical management of a mass-casualty incident (MCI) with prior chemical, biological, radioactive, nuclear, or explosives (CBRNE) -exposed patients is a component of hospital preparedness procedures. OBJECTIVE: The objective of this research was to determine whether a Virtual Emergency Department (VED), designed after the Stanford University Medical Center's Emergency Department (ED) and populated with 10 virtual patient victims who suffered from a dirty bomb blast (radiological) and 10 who suffered from exposure to a nerve toxin (chemical), is an effective clinical environment for training ED physicians and nurses for such MCIs. METHODS: Ten physicians with an average of four years of post-training experience, and 12 nurses with an average of 9.5 years of post-graduate experience at Stanford University Medical Center and San Mateo County Medical Center participated in this IRB-approved study. All individuals were provided electronic information about the clinical features of patients exposed to a nerve toxin or radioactive blast before the study date and an orientation to the "game" interface, including an opportunity to practice using it immediately prior to the study. An exit questionnaire was conducted using a Likert Scale test instrument. RESULTS: Among these 22 trainees, two-thirds of whom had prior Code Triage (multiple casualty incident) training, and one-half had prior CBRNE training, about two-thirds felt immersed in the virtual world much or all of the time. Prior to the training, only four trainees (18%) were confident about managing CBRNE MCIs. After the training, 19 (86%) felt either "confident" or "very confident", with 13 (59%) attributing this change to practicing in the virtual ED. Twenty-one (95%) of the trainees reported that the scenarios were useful for improving healthcare team skills training, the primary objective for creating them. Eighteen trainees (82%) believed that the cases also were instructive in learning about clinical skills management of such incidents. CONCLUSIONS: These data suggest that training healthcare teams in online, virtual environments with dynamic virtual patients is an effective method of training for management of MCIs, particularly for uncommonly occurring incidents.

Impact of treatment guidelines and implementation of a quality assurance program on quality of care in endometrial cancer.

BACKGROUND: The treatment guidelines in the last decade have shown a trend towards increasing surgical radicality in endometrial cancer. Little information is available on the implementation of standards into clinical reality. We evaluated the adherence to standard therapy before and after introduction of an internal quality management system and determined the reasons for non-adherence. PATIENTS AND METHODS: A retrospective analysis of the inhouse tumor registry was performed. Included were all patients with Federation of Gynecology and Obstetrics (FIGO) I-III endometrial cancer and therapy at the Dr. Horst Schmidt Klinik (HSK) from 1997 to 2007. RESULTS: 206 patients with epithelial endometrial cancer in stage FIGO I-III underwent primary surgery at the HSK. 140 (68%) patients were operated as recommended by the guidelines. 20% of patients were operated less radically (17% vs. 22% before and after introduction of guidelines; p = 0.33) and 12% more radically. The latter was significantly reduced after implementation of quality management (21% vs. 7%; p = 0.004). Comorbidities and age played an important role in less-than-standard treatment. CONCLUSIONS: Adherence to guideline-based therapy for endometrial cancer can be achieved in most patients. Implementation of standards and quality assurance primarily helps to avoid surgical overtreatment but failed to reduce less-than-standard treatment radicality. The latter seemed to be more defined by patient characteristics than by institution standards.

Design, development, and evaluation of an online virtual emergency department for training trauma teams.

BACKGROUND: Training interdisciplinary trauma teams to work effectively together using simulation technology has led to a reduction in medical errors in emergency department, operating room, and delivery room contexts. High-fidelity patient simulators (PSs)-the predominant method for training healthcare teams-are expensive to develop and implement and require that trainees be present in the same place at the same time. In contrast, online computer-based simulators are more cost effective and allow simultaneous participation by students in different locations and time zones. In this pilot study, the researchers created an online virtual emergency department (Virtual ED) for team training in crisis management, and compared the effectiveness of the Virtual ED with the PS. We hypothesized that there would be no difference in learning outcomes for graduating medical students trained with each method. METHODS: In this pilot study, we used a pretest-posttest control group, experimental design in which 30 subjects were randomly assigned to either the Virtual ED or the PS system. In the Virtual ED each subject logged into the online environment and took the role of a team member. Four-person teams worked together in the Virtual ED, communicating in real time with live voice over Internet protocol, to manage computer-controlled patients who exhibited signs and symptoms of physical trauma. Each subject had the opportunity to be the team leader. The subjects' leadership behavior as demonstrated in both a pretest case and a posttest case was assessed by 3 raters, using a behaviorally anchored scale. In the PS environment, 4-person teams followed the same research protocol, using the same clinical scenarios in a Simulation Center. Guided by the Emergency Medicine Crisis Resource Management curriculum, both the Virtual ED and the PS groups applied the basic principles of team leadership and trauma management (Advanced Trauma Life Support) to manage 6 trauma cases-a pretest case, 4 training cases, and a posttest case. The subjects in each group were assessed individually with the same simulation method that they used for the training cases. RESULTS: Subjects who used either the Virtual ED or the PS showed significant improvement in performance between pretest and posttest cases (P < 0.05). In addition, there was no significant difference in subjects' performance between the 2 types of simulation, suggesting that the online Virtual ED may be as effective for learning team skills as the PS, the method widely used in Simulation Centers. Data on usability and attitudes toward both simulation methods as learning tools were equally positive. DISCUSSION: This study shows the potential value of using virtual learning environments for developing medical students' and resident physicians' team leadership and crisis management skills.

Simulation for team training and assessment: case studies of online training with virtual worlds.

Individuals in clinical training programs concerned with critical medical care must learn to manage clinical cases effectively as a member of a team. However, practice on live patients is often unpredictable and frequently repetitive. The widely substituted alternative for real patients-high-fidelity, manikin-based simulators (human patient simulator)-are expensive and require trainees to be in the same place at the same time, whereas online computer-based simulations, or virtual worlds, allow simultaneous participation from different locations. Here we present three virtual world studies for team training and assessment in acute-care medicine: (1) training emergency department (ED) teams to manage individual trauma cases; (2) prehospital and in-hospital disaster preparedness training; (3) training ED and hospital staff to manage mass casualties after chemical, biological, radiological, nuclear, or explosive incidents. The research team created realistic virtual victims of trauma (6 cases), nerve toxin exposure (10 cases), and blast trauma (10 cases); the latter two groups were supported by rules-based, pathophysiologic models of asphyxia and hypovolemia. Evaluation of these virtual world simulation exercises shows that trainees find them to be adequately realistic to "suspend disbelief," and they quickly learn to use Internet voice communication and user interface to navigate their online character/avatar to work effectively in a critical care team. Our findings demonstrate that these virtual ED environments fulfill their promise of providing repeated practice opportunities in dispersed locations with uncommon, life-threatening trauma cases in a safe, reproducible, flexible setting.

Assessment of resident professionalism using high-fidelity simulation of ethical dilemmas.

OBJECTIVES: To examine the responses of emergency medicine residents (EMRs) to ethical dilemmas in high-fidelity patient simulations as a means of assessing resident professionalism. METHODS: This cross-sectional observational study included all EMRs at a three-year training program. Subjects were excluded if they were unable or unwilling to participate. Each resident subject participated in a simulated critical patient encounter during an Emergency Medicine Crisis Resource Management course. An ethical dilemma was introduced before the end of each simulated encounter. Resident responses to that dilemma were compared with a professional performance checklist evaluation. Multi-response permutation procedure analysis was used to compare performance measures between resident classes, with the a priori hypothesis that mean performance should increase as experience increases. RESULTS: Of the 30 potential subjects, 90% (27) participated. The remaining three residents were unavailable due to scheduling conflicts. It was observed that senior residents (second and third year) performed more checklist items than did first-year residents (p < 0.028 for each senior class). Omnibus comparison of mean critical actions completed across all three years was not statistically significant (p < 0.13). Residents performed a critical action with 100% uniformity across training years in only one ethical scenario ("Practicing Procedures on the Recently Dead"). Residents performed the fewest critical actions and overall checklist items for the "Patient Confidentiality" case. CONCLUSIONS: Senior residents had better overall performance than incoming interns, suggesting that professional behaviors are learned through some facet of residency training. Although limited by small sample size, the application of this performance-assessment tool showed the ability to discriminate between experienced and inexperienced EMRs with respect to a variety of aspects of professional competency. These findings suggest a need for improved resident education in areas of professionalism and ethics.

Emergency medicine crisis resource management (EMCRM): pilot study of a simulation-based crisis management course for emergency medicine.

OBJECTIVES: To determine participant perceptions of Emergency Medicine Crisis Resource Management (EMCRM), a simulation-based crisis management course for emergency medicine. METHODS: EMCRM was created using Anesthesia Crisis Resource Management (ACRM) as a template. Thirteen residents participated in one of three pilot courses of EMCRM; following a didactic session on principles of human error and crisis management, the residents participated in simulated emergency department crisis scenarios and instructor-facilitated debriefing. The crisis simulations involved a computer-enhanced mannequin simulator and standardized patients. After finishing the course, study subjects completed a horizontal numerical scale survey (1 = worst rating to 5 = best rating) of their perceptions of EMCRM. Descriptive statistics were calculated to evaluate the data. RESULTS: The study subjects found EMCRM to be enjoyable (4.9 +/- 0.3) (mean +/- SD) and reported that the knowledge gained from the course would be helpful in their practices (4.5 +/- 0.6). The subjects believed that the simulation environment prompted realistic responses (4.6 +/- 0.8) and that the scenarios were highly believable (4.8 +/- 0.4). The participants reported that EMCRM was best suited for residents (4.9 +/- 0.3) but could also benefit students and attending physicians. The subjects believed that the course should be repeated every 8.2 +/- 3.3 months. CONCLUSIONS: The EMCRM participants rated the course very favorably and believed that the knowledge gained would be beneficial in their practices. The extremely positive response to EMCRM found in this pilot study suggests that this training modality may be valuable in training emergency medicine residents.

Teaching procedural skills to medical students: one institution's experience with an emergency procedures course.

STUDY OBJECTIVE: We examine the effect of a preclinical emergency procedures course on students' clinical procedural skills and medical knowledge. METHODS: This is a retrospective review of evaluation forms for a cohort of 86 students graduating from medical school at an academic center. A cross section of students (n=57) taking a clinical emergency medicine rotation over a 4-year period was also studied. Numeric scores (1 to 9 on a Likert scale) in procedural skills and medical knowledge categories were extracted from evaluations for internal medicine, surgery, obstetrics and gynecology, and emergency medicine rotations. Scores of students who had taken an elective course, Essential Procedures in Emergency Medicine (EPEM), were compared with scores of students who did not take this course. US Medical Licensing Examination Step I scores for both groups were also compared. RESULTS: Students who took EPEM scored significantly higher in the procedural skills category during the emergency medicine rotation (P =.04) and during both months of the internal medicine rotation (P =.02; P =.02). Students scored on average higher in the surgery and obstetrics and gynecology rotations, but these differences were not statistically significant. Students who took EPEM scored significantly higher in the medical knowledge category for emergency medicine (P =.01; P =.002), both months of internal medicine (P =.03; P =.006), and 1 of 2 months of surgery (P =.01) rotations. Students in obstetrics and gynecology rotations scored higher, although not significantly. US Medical Licensing Examination Step I scores were not different between students taking or not taking EPEM. CONCLUSION: Students taking EPEM achieved higher procedural skill and medical knowledge scores in clinical rotations. Emergency medicine is a specialty well suited to study procedures teaching and performance.

Virtual reality and simulation: training the future emergency physician.

The traditional system of clinical education in emergency medicine relies on practicing diagnostic, therapeutic, and procedural skills on live patients. The ethical, financial, and practical weaknesses of this system are well recognized, but the alternatives that have been explored to date have shown even greater flaws. However, ongoing progress in the area of virtual reality and computer-enhanced simulation is now providing educational applications that show tremendous promise in overcoming most of the deficiencies associated with live-patient training. It will be important for academic emergency physicians to become more involved with this technology to ensure that our educational system benefits optimally.