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Background: The ability of medical students to speak up before a medical error occurs is a timely and necessary interaction to prevent potential patient harm. As it may be crucial to improve patient safety, we explored how medical students react to a medical error and provided them appropriate training regarding speaking up about medical issues., Methods: A quasi-experimental study was conducted in Taiwan involving 153 medical students who participated in a speaking-up simulation course. They were divided into two groups. The first group participated in a non-life-threatening scenario before the intervention, followed by a personalized debriefing session, then a life-threatening scenario after the intervention. The second group participated in a life-threatening scenario before the intervention, followed by a personalized debriefing session, then a non-life-threatening scenario after the intervention. Students also completed patient safety attitude survey., Results: During the preintervention scenario, the overall medical students' speaking-up rate to medical error was 45.1%. The speaking-up rate of medical students in life-threatening scenario was significantly higher than the rate in non-life-threatening scenario before the intervention (64.6% vs 24.3%, p  < 0.001). After personalized debriefing, the speaking-up rate to medical errors was significantly improved both in life-threatening scenarios (95.9%, p  < 0.001) and in non-life-threatening scenarios (100%, p <  0.001). Male medical students had significantly higher speaking-up rates than female students in life-threatening scenario (76.2% vs 51.4%, p  = 0.02). On post-intervention surveys, students provided several reasons for their likelihood of speaking up or remaining silent during a medical error event., Conclusions: Medical students' rate of speaking-up to medical error was higher in a simulated life-threatening scenario than in a simulated non-life-threatening scenario. Faculty-led personalized debriefing can facilitate medical students' adoption of communication strategies to speak up more in medical error events. Educators should also consider gender differences when they design effective assertive communication courses.[Box: see text].

Medical education researchers are often subject to challenges that include lack of funding, collaborators, study subjects, and departmental support. The construct of a research lab provides a framework that can be employed to overcome these challenges and effectively support the work of medical education researchers; however, labs are relatively uncommon in the medical education field. Using case examples, the authors describe the organization and mission of medical education research labs contrasted with those of larger research team configurations, such as research centers, collaboratives, and networks. They discuss several key elements of education research labs: the importance of lab identity, the signaling effect of a lab designation, required infrastructure, and the training mission of a lab. The need for medical education researchers to be visionary and strategic when designing their labs is emphasized, start-up considerations and the likelihood of support for medical education labs is considered, and the degree to which department leaders should support such labs is questioned., (Copyright © 2022 by the Association of American Medical Colleges.)

Background: Tactical Combat Casualty Care (TCCC) is the standard of care for stabilization and treatment of military trauma patients. The Department of Defense has mandated that all service members receive role-based TCCC training and certification. Simulation education can increase procedural skills by providing opportunities for deliberate practice in safe, controlled environments. We developed and evaluated the effectiveness of a simulation-based TCCC training intervention to improve participants' skill performance and self-confidence in tourniquet placement., Methods: This study was a single-blinded, randomized trial with waitlist controls. Army Reserve Officers Training Corp cadets from a single training battalion comprised the study population. After randomization and baseline assessment of all participants, group A alone received focused, simulation-based TCCC tourniquet application training. Three months later, all participants underwent repeat testing, and after crossover, the waitlist group B received the same intervention. Two months later, all cadets underwent a third/final assessment. The primary outcome was tourniquet placement proficiency assessed by total score achieved on a standardized eight-item skill checklist. A secondary outcome was self-confidence in tourniquet application skill as judged by participants' Likert scale ratings., Results: Forty-three Army Reserve Officers Training Corp cadets completed the study protocol. Participants in both group A (n = 25) and group B (n = 18) demonstrated significantly higher performance from baseline to final assessment at 5 months and 2 months, respectively, following the intervention. Mean total checklist score of the entire study cohort increased significantly from 5.53 (SD = 2.00) at baseline to 7.56 (SD = 1.08) at time 3, a gain of 36.7% ( p < 0.001). Both groups rated their self-confidence in tourniquet placement significantly higher following the training., Conclusion: A simulation-based TCCC curriculum resulted in significant, consistent, and sustained improvement in participants' skill proficiency and self-confidence in tourniquet placement. Participants maintained these gains 2 months to 5 months after initial training., Level of Evidence: Therapeutic/care management; Level II., (Copyright © 2022 Written work prepared by employees of the Federal Government as part of their official duties is, under the U.S. Copyright Act, a “work of the United States Government” for which copyright protection under Title 17 of the United States Code is not available. As such, copyright does not extend to the contributions of employees of the Federal Government.)

Background: Training medical students to speak up when they witness a potential error is an important competency for patient safety, but details regarding the barriers that prevent medical students from effectively communicating are lacking. Therefore, this study aimed at exploring the factors affecting medical students' willingness to speak up for patient safety when a medical error was observed., Methods: This is a cross-sectional study at a medical university in Taiwan, and 151 medical students in clinical clerkship completed a survey including demographic characteristics, conflict of interests/social relationship, personal capability, and personality and characteristics of senior staff domains. Data were analyzed using t -test., Results: Three of five items in the conflict of interests/social relationship domain showed statistically significant importance, including 'I am afraid of being punished' (Mean difference, MD = 0.37; p  < 0.01), 'I do not want to break unspoken rules' (MD = 0.55; p  < 0.01), and 'I do not want to have bad team relationship' (MD = 0.58; p  < 0.01). Two items (perception of knowledge/understanding and communication skills) in the personal capability domain were significantly important to speaking up. Six of 10 items in personality and characteristics of senior staff domain were rated significantly important in deciding to speak up. The top three factors of them were senior personnel with 'Grumpy' personality (MD = 1.20; p  < 0.01), 'hierarchy gap' (MD = 1.12; p  < 0.01), and senior personnel with 'Stubborn' personality (MD = 1.06; p  < 0.01)., Conclusion: Our findings demonstrated medical students' perspectives on barriers to speaking up in the event of medical error. Some factors related to characteristics of senior staff could compromise medical students' ability to speak up in the event of medical error. These results might be important for medical educators in designing personalized educational activities related to medical students' ability to speak up for patient safety.

Contemporary clinical practice places a high demand on healthcare workforces due to complexity and rapid evolution of guidelines. We need embedded workplace practices such as clinical debriefing (CD) to support everyday learning and patient care. Debriefing, defined as a 'guided reflective learning conversation', is most often undertaken in small groups following simulation-based experiences. However, emerging evidence suggests that debriefing may also enhance learning in clinical environments where facilitators need to simultaneously balance psychological safety, learning goals and emotional well-being. This twelve tips article summarises international experience collated at the recent Association for Medical Education in Europe (AMEE) debriefing symposium. These tips encompass the benefits of CD, as well as suggested approach to facilitation. Successful CD programmes are frequently team focussed, interdisciplinary, implemented in stages and use a clear structure.

Statement: This article presents reflections of career pathways of simulation researchers as well as a discussion of the themes found in the stories presented. It is the intent of the authors to present and foster a discussion around the ways in which we as a simulation community wish to promote recognition of scholarship among simulation researchers and help support newcomers find success as simulation researchers in academia. We also present recommendations for those considering entering the field based on tactics that were successful and not successful among the scholars who shared their stories.

The Accreditation Council for Graduate Medical Education and the American Board of Physical Medicine and Rehabilitation developed milestones for evaluation of resident physicians that include proper musculoskeletal ultrasound examination of major joints. To date, there have been no published data demonstrating acquisition and retention of these skills and correlation with the milestone evaluation. The investigators developed and implemented a curriculum in musculoskeletal ultrasound examination for Physical Medicine and Rehabilitation residents at a large academic medical center. The investigators chose the following six joints for training and evaluation: ankle, elbow, hip, knee, shoulder, and wrist/hand. The program included: (1) didactic lectures on anatomy and ultrasound technique; (2) peer-led demonstrations of the procedure on a standardized patient (SP); (3) individual practice on standardized patients; (4) faculty observation and feedback; (5) review sessions and additional practice; and (6) assessment of skills in an objective structured clinical examination. From 2013 to 2017, 30 physical medicine and rehabilitation residents were trained and evaluated. The results, based on objective structured clinical examination scores, showed that most residents achieved the appropriate level of competency for their year. A blended, standardized curriculum in musculoskeletal ultrasound instruction with assessment by an objective structured clinical examination can be used to evaluate musculoskeletal ultrasound skills and can help align this education with residency milestones.

Purpose: To investigate the safety and efficacy of durvalumab, a human monoclonal antibody that binds programmed cell death ligand-1 (PD-L1), and the role of PD-L1 expression on clinical response in patients with advanced urothelial bladder cancer (UBC)., Methods: A phase 1/2 multicenter, open-label study is being conducted in patients with inoperable or metastatic solid tumors. We report here the results from the UBC expansion cohort. Durvalumab (MEDI4736, 10 mg/kg every 2 weeks) was administered intravenously for up to 12 months. The primary end point was safety, and objective response rate (ORR, confirmed) was a key secondary end point. An exploratory analysis of pretreatment tumor biopsies led to defining PD-L1-positive as ≥ 25% of tumor cells or tumor-infiltrating immune cells expressing membrane PD-L1., Results: A total of 61 patients (40 PD-L1-positive, 21 PD-L1-negative), 93.4% of whom received one or more prior therapies for advanced disease, were treated (median duration of follow-up, 4.3 months). The most common treatment-related adverse events (AEs) of any grade were fatigue (13.1%), diarrhea (9.8%), and decreased appetite (8.2%). Grade 3 treatment-related AEs occurred in three patients (4.9%); there were no treatment-related grade 4 or 5 AEs. One treatment-related AE (acute kidney injury) resulted in treatment discontinuation. The ORR was 31.0% (95% CI, 17.6 to 47.1) in 42 response-evaluable patients, 46.4% (95% CI, 27.5 to 66.1) in the PD-L1-positive subgroup, and 0% (95% CI, 0.0 to 23.2) in the PD-L1-negative subgroup. Responses are ongoing in 12 of 13 responding patients, with median duration of response not yet reached (range, 4.1+ to 49.3+ weeks)., Conclusion: Durvalumab demonstrated a manageable safety profile and evidence of meaningful clinical activity in PD-L1-positive patients with UBC, many of whom were heavily pretreated., (© 2016 by American Society of Clinical Oncology.)

Purpose: The objective was to determine the safety and clinical activity of atezolizumab (MPDL3280A), a humanized programmed death-ligand 1 (PD-L1) antibody, in renal cell carcinoma (RCC). Exploratory biomarkers were analyzed and associated with outcomes., Patients and Methods: Seventy patients with metastatic RCC, including clear cell (ccRCC; n = 63) and non-clear cell (ncc; n = 7) histologies, received atezolizumab intravenously every 3 weeks. PD-L1 expression was scored at four diagnostic levels (0/1/2/3) that were based on PD-L1 staining on tumor cells and tumor-infiltrating immune cells (IC) with the SP142 assay. Primary end points were safety and toxicity; secondary end points assessed clinical activity per Response Evaluation Criteria in Solid Tumors version 1.1 and immune-related response criteria. Plasma and tissue were analyzed for potential biomarkers of atezolizumab response., Results: Grade 3 treatment-related and immune-mediated adverse events occurred in 17% and 4% of patients, respectively, and there were no grade 4 or 5 events. Sixty-three patients with ccRCC were evaluable for overall survival (median, 28.9 months; 95% CI, 20.0 months to not reached) and progression-free survival (median, 5.6 months; 95% CI, 3.9 to 8.2 months), and 62 patients were evaluable for objective response rate (ORR; 15%; 95% CI, 7% to 26%). ORR was evaluated on the basis of PD-L1 IC expression (IC1/2/3: n = 33; 18%; 95% CI, 7% to 35%; and IC0: n = 22; 9%; 95% CI, 1% to 29%). The ORR for patients with Fuhrman grade 4 and/or sarcomatoid histology was 22% (n = 18; 95% CI, 6% to 48%). Decreases in circulating plasma markers and acute-phase proteins and an increased baseline effector T-cell-to-regulatory T-cell gene expression ratio correlated with response to atezolizumab., Conclusion: Atezolizumab demonstrated a manageable safety profile and promising antitumor activity in patients with metastatic RCC. Correlative studies identified potential predictive and pharmacodynamic biomarkers. These results have guided ongoing studies and combinations with atezolizumab in RCC., (© 2016 by American Society of Clinical Oncology.)

Physicians' career interest in geriatric medicine continues to wane at a time when the health care needs of older adults are increasing. Nurse practitioners have helped fill the U.S. physician gap by delivering outpatient care to older adults and can practice with full autonomy in many states. Nursing graduate school programs are preparing adult-gerontology primary care nurse practitioners to successfully deliver outpatient care services using a model of training with fewer requirements that is more flexible and of shorter duration compared with the training model for geriatricians. Nurse practitioners can also obtain initial certification and recertification with less time commitment and at lower cost than geriatricians. Whether the outpatient care provided by nurse practitioners is comparable to the care provided by physicians remains a subject of debate. However, as nurse practitioners' scope of practice expands, the perception exists that the outpatient clinical roles of adult-gerontology primary care nurse practitioners and geriatricians are similar. This raises questions about whether there are too many educational and certification requirements for geriatricians. The authors encourage medical educators to learn from the success of the nurse practitioner education model for training large numbers of primary care providers. They propose decreasing the duration of medical school and graduate medical education training for geriatricians and providing educational debt repayment programs as potential incentives to stimulate career interest in geriatric medicine.

Purpose: Cabozantinib (XL184), an oral inhibitor of multiple receptor tyrosine kinases such as MET and VEGFR2, was evaluated in a phase II nonrandomized expansion study in castration-resistant prostate cancer (CRPC)., Patients and Methods: Patients received open-label cabozantinib at daily starting doses of 100 mg or 40 mg until disease progression or unacceptable toxicity. The primary end point was bone scan response, defined as ≥ 30% reduction in bone scan lesion area. Other efficacy end points included overall survival, pain, analgesic use, and biomarkers., Results: One hundred forty-four patients sequentially enrolled in either a 100-mg (n = 93) or 40-mg (n = 51) study cohort. Ninety-one patients (63%) had a bone scan response, often by week 6. Treatment resulted in clinically meaningful pain relief (57% of patients) and reduction or discontinuation of narcotic analgesics (55% of patients), as well as improvements in measurable soft tissue disease, circulating tumor cells, and bone biomarkers. Improvements in each of these outcomes were observed in both cohorts: bone scan response in 73% and 45%, respectively; reductions in measurable soft tissue disease in 80% and 79%, respectively. Median overall survival was 10.8 months for the entire population. Most common grade 3 or 4 adverse events were fatigue (22%) and hypertension (14%). Fewer dose reductions because of toxicity were required in the 40-mg group., Conclusion: The evidence suggests that cabozantinib has clinically meaningful activity in CRPC. Cabozantinib resulted in improvements in bone scans, pain, analgesic use, measurable soft tissue disease, circulating tumor cells, and bone biomarkers. Taken together, these phase II observations warrant further development of cabozantinib in prostate cancer., (© 2014 by American Society of Clinical Oncology.)

Medical education research contributes to translational science (TS) when its outcomes not only impact educational settings, but also downstream results, including better patient-care practices and improved patient outcomes. Simulation-based medical education (SBME) has demonstrated its role in achieving such distal results. Effective TS also encompasses implementation science, the science of health-care delivery. Educational, clinical, quality, and safety goals can only be achieved by thematic, sustained, and cumulative research programs, not isolated studies. Components of an SBME TS research program include motivated learners, curriculum grounded in evidence-based learning theory, educational resources, evaluation of downstream results, a productive research team, rigorous research methods, research resources, and health-care system acceptance and implementation. National research priorities are served from translational educational research. National funding priorities should endorse the contribution and value of translational education research.

During the past 15 years there has been widespread adoption of simulation in health care education as a method to train and assess learners. Multiple factors have contributed to this movement, including reduced patient availability, limited faculty teaching time, technological advances in diagnosis and treatment that require a new skills set, greater attention to patient safety with the need to reduce medical errors, and a focus on outcomes-based education. In this discussion, simulation refers broadly to any device or set of conditions that attempts to present the patient authentically. While simulation offers many advantages over traditional methods of teaching, there are several challenges that must be addressed to ensure its effective use. This article presents the range of available simulation technologies, explores the challenges that health care educators face when using this method, provides an example of a successful program that has integrated simulation into the culture of learning at its institution, and discusses an approach to maximizing the effectiveness of simulation as a means to learning and practicing skills in a safe, interactive environment.