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Together, these actions will help the medical education community earn the public’s trust by enhancing the rigor of assessment to ensure the mastery of skills that are essential to providing safe, high-quality care for patients.The COVID-19 pandemic interrupted administration of the United States Medical Licensing Examination (USMLE) Step 2 Clinical Skills (CS) exam in March 2020 due to public health concerns. As the scope and magnitude of the pandemic became clearer, the initial plans by the USMLE program’s sponsoring organizations (NBME and Federation of State Medical Boards) to resume Step 2 CS in the short-term shifted to long-range plans to relaunch an exam that could harness technology and reduce infection risk. Insights about ongoing changes in undergraduate and graduate medical education and practice environments, coupled with challenges in delivering a transformed examination during a pandemic, led to the January 2021 decision to permanently discontinue Step 2 CS. Despite this, the USMLE program considers assessment of clinical skills to be critically important. The authors believe this decision will facilitate important advances in assessing clinical skills. Factors contributing to the decision included concerns about achieving desired goals within desired timeframes; a review of enhancements to clinical skills training and assessment that have occurred since the launch of Step 2 CS in 2004; an opportunity to address safety and health concerns, including those related to examinee stress and wellness during a pandemic; a review of advances in the education, training, practice, and delivery of medicine; and a commitment to pursuing innovative assessments of clinical skills. selleck chemicals llc USMLE program staff continue to seek input from varied stakeholders to shape and prioritize technological and methodological enhancements to guide development of clinical skills assessment. The USMLE program’s continued exploration of constructs and methods by which communication skills, clinical reasoning, and physical examination may be better assessed within the remaining components of the exam provides opportunities for examinees, educators, regulators, the public, and other stakeholders to provide input.Once medical students attain a certain level of medical knowledge, success in residency often depends on noncognitive attributes, such as conscientiousness, empathy, and grit. These traits are significantly more difficult to assess than cognitive performance, creating a potential gap in measurement. Despite its promise, competency-based medical education (CBME) has yet to bridge this gap, partly due to a lack of well-defined noncognitive observable behaviors that assessors and educators can use in formative and summative assessment. As a result, typical undergraduate to graduate medical education handovers stress standardized test scores, and program directors trust little of the remaining information they receive, sometimes turning to third-party companies to better describe potential residency candidates. The authors have created a list of noncognitive attributes, with associated definitions and noncognitive skills-called observable practice activities (OPAs)-written for learners across the continuum to help educators collect assessment data that can be turned into valuable information. OPAs are discrete work-based assessment elements collected over time and mapped to larger structures, such as milestones, entrustable professional activities, or competencies to create learning trajectories for formative and summative decisions. Medical schools and graduate medical education programs could adapt these OPAs or determine ways to create new ones specific to their own contexts. Once OPAs are created, programs will have to find effective ways to assess them, interpret the data, determine consequence validity, and communicate information to learners and institutions. The authors discuss the need for culture change surrounding assessment-even for the adoption of behavior-based tools such as OPAs-including grounding the work in a growth mindset and the broad underpinnings of CBME. Ultimately, improving assessment of noncognitive capacity should benefit learners, schools, programs, and most importantly, patients.BackgroundVRC01, a potent, broadly neutralizing monoclonal antibody, inhibits simian-HIV infection in animal models. The HVTN 104 study assessed the safety and pharmacokinetics of VRC01 in humans. We extend the clinical evaluation to determine intravenously infused VRC01 distribution and protective function at mucosal sites of HIV-1 entry.MethodsHealthy, HIV-1-uninfected men (n = 7) and women (n = 5) receiving VRC01 every 2 months provided mucosal and serum samples once, 4-13 days after infusion. Eleven male and 8 female HIV-seronegative volunteers provided untreated control samples. VRC01 levels were measured in serum, secretions, and tissue, and HIV-1 inhibition was determined in tissue explants.ResultsMedian VRC01 levels were quantifiable in serum (96.2 μg/mL or 1.3 pg/ng protein), rectal tissue (0.11 pg/ng protein), rectal secretions (0.13 pg/ng protein), vaginal tissue (0.1 pg/ng protein), and cervical secretions (0.44 pg/ng protein) from all recipients. VRC01/IgG ratios in male serum correlated with those in paired rectal tissue (r = 0.893, P = 0.012) and rectal secretions (r = 0.9643, P = 0.003). Ex vivo HIV-1Bal26 challenge infected 4 of 21 rectal explants from VRC01 recipients versus 20 of 22 from controls (P = 0.005); HIV-1Du422.1 infected 20 of 21 rectal explants from VRC01 recipients and 12 of 12 from controls (P = 0.639). HIV-1Bal26 infected 0 of 14 vaginal explants of VRC01 recipients compared with 23 of 28 control explants (P = 0.003).ConclusionIntravenous VRC01 distributes into the female genital and male rectal mucosa and retains anti-HIV-1 functionality, inhibiting a highly neutralization-sensitive but not a highly resistant HIV-1 strain in mucosal tissue. These findings lend insight into VRC01 mucosal infiltration and provide perspective on in vivo protective efficacy.FundingNational Institute of Allergy and Infectious Diseases and Bill & Melinda Gates Foundation.