Next steps for workplace-based assessments of entrustable professional activities.

BACKGROUND: Florida International University Herbert Wertheim College of Medicine (FIU-HWCOM) participated in the AAMC Core Entrustable Professional Activities (EPA) implementation pilot. Entrustment decision processes based on data from workplace-based assessments (WBAs) were piloted. Outcomes illustrated challenges including variability across EPAs with regards to learner level alignment and feasibility of data collection in the form of WBAs. In addition, students reported discomfort requesting WBA completion by preceptors and dissatisfaction with associated feedback. APPROACH: To guide future directions, we conducted a survey of third-year students to better understand their experience with and perceptions of WBAs used to evaluate EPAs at FIU-HWCOM. EVALUATION: Survey response was 96% (n = 107/112). Most (84%) reported that WBAs were not valuable to their development and that preceptors often did not complete WBAs in a timely fashion. Many (47%) reported not receiving verbal feedback. Most students (78%) used language in written responses demonstrating confusion between the EPAs and the WBAs used to assess them. IMPLICATIONS: The use of WBAs to assess EPAs did not have its intended impact at FIU-HWCOM. For future classes, WBA forms will consist of paper cards with questions directly assessing performance of skills aligned with EPAs 1, 5 and 6 only. To continue to promote feedback, students will be required to collect WBAs on all clerkships, but the number of required WBAs will be less than prior and no entrustment decisions will be made.

Medical Students' Perspectives on Opportunities to Engage in the Clinical Care of COVID-19 Patients during the Pandemic.

OBJECTIVES: Recent disease modeling suggests that pandemics are likely to increase in frequency and severity. As such, medical educators must learn from their experiences with coronavirus disease 2019 (COVID-19) to develop systematic strategies for ensuring that medical students receive hands-on training in the management of emerging diseases. Here, we outline the process by which the Florida International University Herbert Wertheim College of Medicine developed and updated guidelines for student participation in the care of patients with COVID-19 and report on students' experiences. METHODS: During the 2020-2021 academic year, Florida International University Herbert Wertheim College of Medicine students were not permitted to care for patients with COVID-19; however, academic year 2021-2022 guidelines did permit fourth-year students on subinternships or Emergency Medicine rotations to voluntarily care for patients with COVID-19. At the end of the 2021-2022 academic year, students completed an anonymous survey about their experience caring for patients with COVID-19. Likert-type and multiple-choice questions were analyzed using descriptive statistics and the short-answer responses were analyzed qualitatively. RESULTS: One hundred two students (84%) responded to the survey. Sixty-four percent of respondents opted to provide care for patients with COVID-19. Most students (63%) cared for patients with COVID-19 during their required Emergency Medicine Selective. Twenty-eight percent of students wished they had more COVID-19 patient care opportunities, and 29% did not feel prepared to care for patients with COVID-19 on their first day of residency. CONCLUSIONS: Many graduating students felt unprepared to care for patients with COVID-19 during residency and many wished they had had more opportunities to care for patients with COVID-19 during medical school. Curricular policies must evolve to allow students to gain competency in the care of patients with COVID-19 so that they are prepared for day one of residency.

The Florida Clinical Skills Collaborative: A New Regional Consortium for the Assessment of Clinical Skills.

Discontinuation of the United States Medical Licensing Examination (USMLE) Step 2 Clinical Skills (CS) exam and Comprehensive Osteopathic Medical Licensing Examination (COMLEX) Level 2 Performance Evaluation (2-PE) raised questions about the ability of medical schools to ensure the clinical skills competence of graduating students. In February 2021, representatives from all Florida, United States, allopathic and osteopathic schools initiated a collaboration to address this critically important issue in the evolving landscape of medical education. A 5-point Likert scale survey of all members (n=18/20 individuals representing 10/10 institutions) reveals that initial interest in joining the collaboration was high among both individuals (mean 4.78, SD 0.43) and institutions (mean 4.69, SD 0.48). Most individuals (mean 4.78, SD 0.55) and institutions (mean 4.53, SD 0.72) are highly satisfied with their decision to join. Members most commonly cited a "desire to establish a shared assessment in place of Step 2 CS/2-PE" as their most important reason for joining. Experienced benefits of membership were ranked as the following: 1) Networking, 2) Shared resources for curriculum implementation, 3) Scholarship, and 4) Work towards a shared assessment in place of Step 2 CS/2-PE. Challenges of membership were ranked as the following: 1) Logistics such as scheduling and technology, 2) Agreement on common goals, 3) Total time commitment, and 4) Large group size. Members cited the "administration of a joint assessment pilot" as the highest priority for the coming year. Florida has successfully launched a regional consortium for the assessment of clinical skills competency with high levels of member satisfaction which may serve as a model for future regional consortia.

Osteoporosis: A Small-Group Case-Based Learning Activity.

INTRODUCTION: Osteoporosis is the most common bone disease in the world. Approximately 50% of women and 20% of men over 50 will suffer an osteoporosis-related fracture. Future health care providers must be equipped to prevent, recognize, and treat osteoporosis-related fractures. METHODS: To supplement instruction on osteoporosis, we designed a case-based session. Groups of 10-12 second-year medical students worked with a single facilitator in a roundtable discussion. The 120-minute session integrated foundational sciences (pathology, physiology, pharmacology) and clinical disciplines (clinical skills, radiology, geriatrics, evidence-based medicine). Knowledge gains were assessed by performance on nine session-relevant multiple-choice questions (MCQs) on the final exam. Student satisfaction was assessed by an anonymous postsession survey. RESULTS: There were 121 students that participated, and their average performance on nine session-relevant final exam MCQs was 84%. After removal of a single outlier MCQ (15% correct), average performance on the remaining eight MCQs was 93%. A total of 107 students (88%) responded to the postsession survey. On a 5-point Likert scale, 101 of 107 students (94%) agreed or strongly agreed with the statement "The basic science-clinical combination lecture on osteoporosis followed by the small-group case discussion on osteoporosis prepared me adequately to understand the topic" (M = 4.56, SD = 0.63). DISCUSSION: We developed a case-based learning activity for preclinical medical students to enhance the clinical scaffolding of basic science and medical knowledge around osteoporosis. Students performed well on session-relevant exam questions, demonstrating competency in the educational objectives. Student satisfaction was high, with most students feeling well prepared.

Taking CBL to the Lecture Hall: a Comparison of Outcomes Between Traditional Small Group CBL and a Novel Large Group Team-Based CBL Teaching Method.

PURPOSE: Case-based learning (CBL), an important component of medical school curricula, is an effective inquiry-based teaching method associated with high levels of student and teacher satisfaction. However, because traditional CBL requires small groups, its feasibility is limited by faculty and resources. We developed and tested a novel team-based CBL (TB-CBL) method to be implemented in the lecture hall. METHODS: All second-year students at our institution (n = 121) were randomized to either traditional small group CBL or TB-CBL during the Endocrine block and to the other modality during the Renal block. All students were exposed to both methods. Case content was identical, and sessions were run concurrently. This cross-over, non-inferiority study tested the hypothesis that no difference in knowledge acquisition, clinical reasoning, or student satisfaction would be detected between groups. RESULTS: Based on student performance on case-relevant exam questions, no difference in knowledge acquisition was seen between groups for either block (p = 0.62 Endocrine, p = 0.38 Renal). There was also no difference in overall final exam performance between groups (p = 0.56 Endocrine, p = 0.26 Renal). Case-relevant script concordance testing revealed no difference in clinical reasoning skills between groups (p = 0.87 Endocrine, p = 0.17 Renal). Satisfaction was higher for the TB-CBL format (p = 0.005). Cost analysis revealed that each small group CBL session costs $2654, while each TB-CBL session costs approximately $221. CONCLUSIONS: TB-CBL, a novel case-based teaching method, appears to produce similar learner outcomes and higher student satisfaction when compared with small group CBL. TB-CBL may be used to supplement case-based curricula while optimizing resource allocation.

Mesenchymal Stem Cells for the Treatment of Idiopathic Pulmonary Fibrosis.

Idiopathic pulmonary fibrosis (IPF) is an inexorably progressive lung disease of unknown origin. Prognosis is poor, with limited treatment options available, and the median survival remains just 3-5 years. Despite the use of pirfenidone and nintedanib for the treatment of IPF, curative therapies remain elusive and mortality remains high. Regenerative medicine and the use of cell-based therapies has recently emerged as a potential option for various diseases. Promising results of preclinical studies using mesenchymal stem cells (MSCs) suggest that they may represent a potential therapeutic option for the treatment of chronic lung diseases including IPF. Encouraging results of Phase 1 studies of MSCs various have reduced safety concerns. Nonetheless, there is still a pressing need for exploratory biomarkers and interval end-points in the context of MSCs investigation. This review intends to summarize the current state of knowledge for stem cells in the experimental and clinical setting of IPF, present important safety and efficacy issues, highlight future challenges and address the need for large, multicenter clinical trials coupled with realistic end-points, including biomarkers, to assess treatment efficacy.

Allogeneic Human Mesenchymal Stem Cells in Patients With Idiopathic Pulmonary Fibrosis via Intravenous Delivery (AETHER): A Phase I Safety Clinical Trial.

BACKGROUND: Despite Food and Drug Administration approval of 2 new drugs for idiopathic pulmonary fibrosis (IPF), curative therapies remain elusive and mortality remains high. Preclinical and clinical data support the safety of human mesenchymal stem cells as a potential novel therapy for this fatal condition. The Allogeneic Human Cells (hMSC) in patients with Idiopathic Pulmonary Fibrosis via Intravenous Delivery (AETHER) trial was the first study designed to evaluate the safety of a single infusion of bone marrow-derived mesenchymal stem cells in patients with idiopathic pulmonary fibrosis. METHODS: Nine patients with mild to moderate IPF were sequentially assigned to 1 of 3 cohorts and dosed with a single IV infusion of 20, 100, or 200 × 106 human bone marrow-derived mesenchymal stem cells per infusion from young, unrelated, men. All baseline patient data were reviewed by a multidisciplinary study team to ensure accurate diagnosis. The primary end point was the incidence (at week 4 postinfusion) of treatment-emergent serious adverse events, defined as the composite of death, nonfatal pulmonary embolism, stroke, hospitalization for worsening dyspnea, and clinically significant laboratory test abnormalities. Safety was assessed until week 60 and additionally 28 days thereafter. Secondary efficacy end points were exploratory and measured disease progression. RESULTS: No treatment-emergent serious adverse events were reported. Two nontreatment-related deaths occurred because of progression of IPF (disease worsening and/or acute exacerbation). By 60 weeks postinfusion, there was a 3.0% mean decline in % predicted FVC and 5.4% mean decline in % predicted diffusing capacity of the lungs for carbon monoxide. CONCLUSIONS: Data from this trial support the safety of a single infusion of human mesenchymal stem cells in patients with mild-moderate IPF. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT02013700; URL: www.clinicaltrials.gov.

Therapeutic benefits of young, but not old, adipose-derived mesenchymal stem cells in a chronic mouse model of bleomycin-induced pulmonary fibrosis.

The observation that pulmonary inflammatory lesions and bleomycin (BLM)-induced pulmonary fibrosis spontaneously resolve in young mice, whereas remaining irreversible in aged mice suggests that impairment of pulmonary regeneration and repair is associated with aging. Because mesenchymal stem cells (MSCs) may promote repair after injury, we postulated that differences in MSCs from aged mice may underlie postinjury fibrosis in aging. The potential for young-donor MSCs to inhibit BLM-induced pulmonary fibrosis in aged male mice (>22 months) has not been studied. Adipose-derived MSCs (ASCs) from young (4 months) and old (22 months) male mice were infused 1 day after intratracheal BLM administration. At 21-day sacrifice, aged BLM mice demonstrated lung fibrosis by Ashcroft score, collagen content, and α(v)-integrin messenger RNA (mRNA) expression. Lung tissue from aged BLM mice receiving young ASCs exhibited decreased fibrosis, matrix metalloproteinase (MMP)-2 activity, oxidative stress, and markers of apoptosis vs BLM controls. Lung mRNA expression of tumor necrosis factor-alpha was also decreased in aged BLM mice receiving young-donor ASCs vs BLM controls. In contrast, old-donor ASC treatment in aged BLM mice did not reduce fibrosis and related markers. On examination of the cells, young-donor ASCs had decreased mRNA expression of MMP-2, insulin-like growth factor (IGF) receptor, and protein kinase B (AKT) activation compared with old-donor ASCs. These results show that the BLM-induced pulmonary fibrosis in aged mice could be blocked by young-donor ASCs and that the mechanisms involve changes in collagen turnover and markers of inflammation.

Mesenchymal stem cells and idiopathic pulmonary fibrosis. Potential for clinical testing.

Idiopathic pulmonary fibrosis (IPF) is a progressive, debilitating, and fatal lung disease characterized by interstitial fibrosis with decreasing lung volumes and hypoxemic respiratory failure. The prognosis for patients with IPF is poor and the quest to find effective therapies has been unsuccessful. Despite several clinical trials over the past decade, there are no U.S. Food and Drug Administration-approved treatments for patients with IPF and thus no standard of care. In terms of pathogenesis, IPF is characterized by alveolar epithelial cell injury and activation with interstitial inflammation, fibroblast proliferation with extracellular matrix collagen deposition, and loss of lung function. Because mesenchymal stem cells (MSCs) home to sites of injury, inhibit inflammation, and contribute to epithelial tissue repair, their use has been suggested as a therapy for the treatment of IPF. MSCs have potential as a novel therapeutic agent in multiple diseases and they have been safely administered in a number of clinical trials. Some, but not all, preclinical studies in animal models of lung fibrosis suggest that MSCs might be effective in the treatment of IPF. Given the safety and ease of MSC administration in other patient populations, the results in preclinical animal models of IPF, and the major need for novel therapeutic options in this devastating disease, we propose that carefully designed clinical trials of MSCs for the treatment of patients with IPF are appropriate. Establishing safety in the setting of IPF is the first priority in early clinical trials followed by clinical and biological measures of efficacy.

The influence of Hispanic ethnicity on nonsmall cell lung cancer histology and patient survival: an analysis of the Survival, Epidemiology, and End Results database.

BACKGROUND: Most studies exploring ethnic/racial disparities in nonsmall cell lung cancer (NSCLC) compare black patients with whites. Currently, the effect of Hispanic ethnicity on the overall survival of NSCLC is poorly understood. Therefore, the authors carried out a large-scale, population-based analysis using the Surveillance, Epidemiology, and End Results (SEER) data base to determine the impact of Hispanic ethnicity the survival of patients with NSCLC. METHODS: The authors identified 172,398 adult patients with pathologically confirmed NSCLC from the SEER data base who were diagnosed between 1988 and 2007. A multivariate Cox proportional hazards regression analysis was used to determine the impact of race/ethnicity on overall survival. Pair-wise comparisons were used to determine whether Hispanic ethnicity influenced NSCLC histology or stage at diagnosis. RESULTS: Compared with non-Hispanic white patients, Hispanic white patients had a statistically significant better overall survival (hazard ratio [HR], 0.85; 95% confidence interval [CI], 0.83-0.87), and black patients had worse survival (HR, 1.091; 95% CI, 1.072-1.109). Within the bronchioalveolar carcinoma (BAC) subtype, Hispanic-white patients tend to be over represented (8.1% Hispanic whites vs 5.5% non-Hispanic whites vs 3.7% blacks; P < .001). CONCLUSIONS: The current study demonstrated that Hispanic-white patients with NSCLC had a decreased risk for overall mortality compared with non-Hispanic whites and blacks. Moreover, Hispanic patients were over represented within the BAC histologic subtype. Thus, the overall survival advantage of Hispanic NSCLC patients may be because of their predilection toward developing certain histologic subtypes of NSCLC. Further studies are warranted to determine the etiologies of such predilections and may reveal certain genetic, environmental, and/or epigenetic factors associated with Hispanic ethnicity.

Tgf-beta signaling pathway in lung adenocarcinoma invasion.

The histologic distinction between bronchioloalveolar carcinoma and other adenocarcinomas is tissue invasion. The clinical importance of lung adenocarcinoma invasion is supported by several recent studies indicating that the risk of death in nonmucinous bronchioloalveolar carcinoma is significantly lower than that of pure invasive tumors and in tumors with greater than 0.5 cm of fibrosis or linear invasion. Using microarray gene expression profiling of human tumors, dysregulation of transforming growth factor-beta signaling was identified as an important mediator of tumor invasion. Subsequent studies showed that the CC chemokine regulated on activation, normal T cell expressed, and presumably secreted was up-regulated in invasive tumors and was required for invasion in cells with repressed levels of the transforming growth factor-beta type II receptor. Taken together, these studies illustrate how information gained from global expression profiling of tumors can be used to identify key pathways and genes mediating tumor growth, invasion, and metastasis.

Sarcoidosis-associated fibrosing mediastinitis with resultant pulmonary hypertension: a case report and review of the literature.

Pulmonary hypertension, a common manifestation of advanced sarcoidosis, is thought to result from fibrosis with chronic hypoxia and destruction of small vessels, extrinsic compression of pulmonary arteries, or granulomatous vasculitis. We report a case of sarcoidosis-associated pulmonary hypertension due to fibrosing mediastinitis. Our patient presented with cough and dyspnea on exertion and was found to have pulmonary artery enlargement, pulmonary venous compression, and mediastinal soft tissue enhancement on magnetic resonance imaging. Pulmonary hypertension was confirmed by right heart catheterization and sarcoidosis was diagnosed by histologic examination of tissue obtained at mediastinoscopy. Treatment with steroids resulted in decreased pulmonary artery pressures as well as symptomatic improvement. While pulmonary hypertension is a common complication of sarcoidosis, fibrosing mediastinitis is an unusual etiology that should be considered by clinicians.

Genomics of lung cancer.

This review focuses on recent research using genomics to examine lung carcinogenesis, histologic differentiation, and progression.

Erythropoietin-deficient anemia associated with autoimmune polyglandular syndrome type I.

Autoimmune polyglandular syndrome type I (APS1), a relatively common disorder in some populations, is frequently associated with adrenal insufficiency, hypoparathyroidism, and other endocrine and skin abnormalities. We describe an 18-year-old male with APS1, as documented by genotyping, who presented with hypoparathyroidism and a normocytic, hypoproliferative, isolated anemia. An extensive hematological work-up revealed a low serum erythropoietin, without any other hematological abnormalities. His renal function was normal, and he did not have many of the laboratory or clinical findings associated with an anemia of chronic disease. His anemia was responsive to superphysiologic doses of erythropoietin. We thus suggest that erythropoietin deficiency may be one of the endocrine abnormalities associated with APS1, and clinicians should be cognizant of the association of treatable anemia in patients with APS1.