Faculty Bibliography

PROBLEM/OBJECTIVE:Undergraduate medical education (UME) often lacks detailed data on student learning in the clinical learning environment, instead relying on self-reported and observational assessments of student involvement in patient care. This reliance on subjective data can lead to inconsistencies and gaps in understanding student experiences during clinical encounters. The electronic health record (EHR) contains a wealth of data that could address these limitations but is underused in UME, limiting objective analysis of student encounters and hindering the ability to monitor and ensure consistent experiences across different clinical sites. APPROACH/METHODS:In 2020, a multidisciplinary team at the Kaiser Permanente Bernard J. Tyson School of Medicine used business intelligence software to develop dashboards that enhance analysis of student experiences in the clinical learning environment. Student encounters were identified using a unique EHR profile that enabled the capture of encounter-level data, which were then exported to a centralized dataset, facilitating creation of dashboards for comprehensive visualization and analysis of student experiences. OUTCOMES/RESULTS:By 2024, 17 dashboards were created that included visit- and patient-specific data. The EHR-linked dashboards featured encounter-specific details (specialty, preceptor, visit type and specialty, chief concern, diagnoses) and patient-specific details (age, race, sex, language, interpreter use). This allowed the capture of student experiences and facilitated analysis of student quality and patient-reported experience metrics. The dashboards also served as feedback tools to ensure comparability between students and cohorts across clinical sites. NEXT STEPS/CONCLUSIONS:The dissemination of individualized student dashboards enables insights into clinical experiences and identifies student contributions to patient care. By sharing rich data, students can pinpoint learning opportunities and faculty can better support curricular goals, advancing precision medical education strategies. This approach can serve as a model for empirical studies on how clinical learning environments shape student development and marks a necessary step toward personalized learning systems in UME.

BACKGROUND/UNASSIGNED:Few studies have directly compared limitations in activities of daily living (ADLs) between reverse shoulder arthroplasty (RSA) and anatomic total shoulder arthroplasty (aTSA). This study evaluates ADL function at mid-term follow-up in patients with revision-free RSA and aTSA. METHODS/UNASSIGNED:This retrospective cohort study included 250 patients who underwent primary aTSA (n = 177) or RSA (n = 73) with a minimum follow-up of 7 years (mean 10 ± 2 years). Patients who had revision surgery were excluded. Multivariable ordinal logistic regression analysis was used to assess the odds of RSA patients reporting better ADL function compared to aTSA patients. RESULTS/UNASSIGNED:Postoperatively, a greater proportion of aTSA patients reported normal ADLs compared to RSA patients. On multivariable analysis, controlling for baseline differences, RSA patients reported lower ADL function for personal hygiene/toilet needs (Odds ratio [OR] 0.21 [95% CI: 0.07-0.65]; p = 0.006), washing/combing hair (OR 0.36 [0.13-1.02]; p = 0.049), putting on a button-up shirt (OR 0.08 [0.02-0.25]; p < 0.001), and putting on pants (OR 0.12 [0.03-0.39]; p < 0.001). DISCUSSION/UNASSIGNED:After adjusting for differences in baseline factors, RSA patients reported greater difficulty with specific ADL tasks-including toileting, personal hygiene, grooming, and dressing-compared to aTSA patients. LEVEL OF EVIDENCE/UNASSIGNED:Level III; Retrospective cohort study.

BACKGROUND:Access to liver transplantation (LT) for pediatric registrants is complex and impacted by many factors. Assessing the state of pediatric LT requires understanding the balance between policy, the availability of livers, and the quantity of pediatric patients requiring LT. METHODS:Using Scientific Registry of Transplant Recipients data with Cox regression (to compare rates) and competing risk regression (to compare cumulative incidence), we evaluated pediatric patient characteristics, number of registrants transplanted, and waitlist mortality from (January 1, 2017-February 4, 2020) to (May 1, 2020-June 4, 2023) using the implementation of acuity circles to divide the eras. RESULTS:In 4314 pediatric LT registrants, transplantation rate increased in the post-policy era, compared with the pre-policy era (adjusted hazard ratio [HR], 1.05 1.12 1.20 ; P  < 0.001). When accounting for competing risks, the increase was attenuated and not statistically significant (adjusted subdistribution HR, 0.99 1.06 1.14 ; P  = 0.08); recipients were no more likely to die on the waitlist (adjusted subdistribution HR, 0.78 1.01 1.30 ; P  = 0.99). Importantly, the prevalent pediatric waitlist dropped from 396 (2017) to 225 (2023), the rate of deceased donor LT from pediatric donors increased (weighted HR, 1.20 1.31 1.42 ; P  < 0.001), and access to living donor LT increased, compared with the pre-policy era (weighted HR, 1.11 1.33 1.59 ; P  = 0.002). The transplant rate for pediatric patients did not decrease during the study period despite the introduction of acuity circles. During the study period, the prevalent waitlist shrank, access to LT from pediatric donors increased, and access to living donor LT increased. CONCLUSIONS:Comprehensive assessment following the policy change is necessary to ensure that pediatric candidates maintain priority. Changes in pediatric transplantation are modest and likely related to changes in the pool, rather than to the policy of acuity circles.

The diagnosis of dermatologic conditions typically hinges on the examination of visibly apparent skin abnormalities. On occasion, dermatologists can aid in diagnosing the "invisible" by performing biopsies of skin that seems clinically normal, with the hope that histologic clues only apparent in tissue samples-and not by the naked eye-may yield helpful diagnostic information. This narrative review discusses the utility of random, normal skin biopsy in the diagnosis of a variety of conditions for which this method has been described. Herein, we review the available literature on the use of normal skin biopsy for Alport syndrome, amyloidosis, atypical hemolytic uremic syndrome; cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy, intravascular lymphoma, lysosomal storage disorders, pseudoxanthoma elasticum, rabies, and small fiber neuropathies.

BACKGROUND:Foundation models have shown remarkable potential in medical imaging by leveraging extensive pretraining on general datasets to enable fine-tuning for specific tasks. This is thought to be particularly beneficial for tasks where annotated data is scarce. A key underlying assumption, however, is that these models can learn from small amounts of training data more efficiently than existing state-of-the-art models. PURPOSE/OBJECTIVE:This study aims to characterize the performance of two major foundation segmentation models (SAM and MedSAM) when fine-tuned to segment neuroanatomic structures across a spectrum of dataset sizes, compared to a standard fully-supervised UNet model. METHODS:This study used 1,113 T1-weighted 3D MRIs from the Human Connectome Project's Young Adult cohort with corresponding Freesurfer-generated, manually-refined segmentations of 93 gray and white matter regions. The dataset was divided into 891 (80%) training MRIs, 111 (10%) validation MRIs, and 111 (10%) testing MRIs. SAM and MedSAM models were first fine-tuned and compared against a standard UNet model using Dice score to establish the baseline performance using all training 3D volumes. Subsequently, MedSAM and UNet models were fine-tuned across a varying number of training volumes to assess performance with diminishing dataset size, down to a single MRI, as well as no MRIs (zero-shot) for the MedSAM and SAM models. RESULTS:Using the entire training set, UNet outperformed MedSAM and SAM across most regions, with median Dice scores of 0.88 versus 0.82 and 0.84, respectively (p < 0.001). With diminishing dataset size, UNet continued to perform as well as or better than MedSAM in the three studied regions, down to even a single 3D volume. In the zero-shot setting, SAM and MedSAM showed some ability to segment with overall median Dice scores of 0.66 and 0.59, respectively. CONCLUSIONS:SAM and MedSAM did not outperform a standard UNet model in segmentation tasks, even in extremely limited training data settings, contrary to the foundation model hypothesis, suggesting that foundation models do not necessarily yield superior fine-tuned performance compared to standard segmentation models in the low data setting. Instead, the potential benefit of foundation models will depend on the characteristics of the task at hand and the behavior and capacity of the specific foundation model in question. Thus, it will be essential to benchmark against standard supervised deep learning methods for each distinct application to demonstrate the added value of using a foundation model.

OBJECTIVES/OBJECTIVE:To evaluate the feasibility and efficacy of a workflow designed to increase the number of patients counseled and initiated on the HPV vaccination series among an underserved patient population presenting for abortion care. METHODS:A retrospective chart review was conducted for 6 months before implementation to determine baseline rates of counseling and vaccine uptake. A workflow was prospectively implemented for 31 weeks at a resident-run urban safety net hospital abortion clinic. Rates of HPV vaccine-eligible patients who were counseled on vaccination were recorded along with rates of those accepting the vaccine who initiated and completed the series. RESULTS:Following implementation, the rate of eligible patients receiving counseling on the HPV vaccine increased from 23.8% to 68.7%. There was a 400% relative increase in the rate of patients receiving at least 1 dose of the vaccine from 6.8% to 34%. Forty-one (41.4%) patients due for a subsequent dose received at least 1 additional dose. Fifteen (14.7%) patients who received at least 1 dose of the HPV vaccine completed the series. The most common primary language among vaccinated patients was Spanish (66.7%). A majority (81.8%) identified their race as Hispanic or Latine, followed by Black (8%), and 13 ethnic backgrounds were self-identified. CONCLUSIONS:Implementation of an HPV vaccination workflow in an abortion clinic was feasible and resulted in substantial increases in counseling and uptake of the vaccine. Abortion care represents an opportunity to address HPV vaccination gaps, particularly among medically under-resourced populations most at risk for cervical cancer disparities.

In the Coronavirus Variant Immunologic Landscape Trial (COVAIL) conducted in the United States in 2022-2023, 985 participants received a second COVID-19 booster with one of twelve monovalent or bivalent mRNA inserts. Pseudovirus serum inhibitory dilution 50% neutralizing antibody titer (nAb titer) measured two-weeks post booster significantly associated with lower COVID-19 incidence over six months follow-up in this trial. COVAIL investigators sequenced SARS-CoV-2 Spike amino acid sequences for all COVID-19 cases, with a sequence successfully obtained from 129 of 195 cases. For COVID-19 endpoint cases we calculated five distances of the case-causing sequence to a reference sequence, the first two physico-chemical weighted Hamming distances of Spike or receptor binding domain (RBD) to a participant's nearest Spike or RBD vaccine-insert sequence, and the other three estimated degrees of neutralizing antibody escape from the XBB.1.5 RBD strain calculated with deep mutational scanning. Hypothesizing that the nAb titer correlate of risk may have a stronger association with COVID-19 when focusing on COVID-19 infections more closely matched to the vaccine insert in Spike or RBD amino acid sequence or with lower RBD antibody escape score, we tested this hypothesis for the combined group receiving a monovalent Prototype (ancestral strain) booster (n = 143) and for the combined group receiving an Omicron-containing booster (n = 744). For both combined groups, the nAb titer correlate of risk did not significantly vary across any of the assessed sequence distances from the vaccine insert (all p-values >0.10), although RBD Hamming distance had point estimates consistent with a weakening correlate with distance, motivating further exploration in settings with greater antigenic heterogeneity. Indeed, statistical power was bounded by the limited antigenic variability of viruses infecting trial participants over the follow-up period (April 21, 2022 to May 25, 2023), which spanned only a 3.02-fold nAb titer range of differential sensitivity to sera from XBB.1.5-infected individuals. ClinicalTrials.gov Identifier: NCT05289037.

OBJECTIVE:The latest European Medicines Agency (EMA) guideline on the clinical investigation of medicines to treat epileptic disorders was adopted by the EMA Committee for Medicinal Products for Human Use in 2025. We compared this guideline with the previous version (2010), highlighting areas where significant revisions were introduced. METHODS:The 2025 and 2010 versions of the guideline were systematically analyzed to identify significant modifications. RESULTS:The latest EMA guideline incorporated terminology from the 2017 International League Against Epilepsy (ILAE) classification of seizures and epilepsy and the 2022 classification of syndromes and replaced the older term "antiepileptic drug (AED)" with "antiseizure medication (ASM)." Recommendations for add-on studies in common epilepsies have remained substantially unchanged, the main revision being the acceptability of the time-to-event design also for confirmatory trials, provided it is not the only design in the clinical development plan. A major novelty is the feasibility of extrapolating data from add-on trials to the monotherapy indication, provided specific conditions are met. Guidance on pediatric ASM development has been expanded, addressing extrapolation of efficacy from data in adults and older children and options for studies in developmental and epileptic encephalopathies and other rare epilepsies. Compared with the previous guideline, greater emphasis is placed on nonseizure outcomes, including functional, quality of life, and patient-reported outcomes. Two new sections have been introduced, addressing studies in neonates and clinical trials in status epilepticus and other seizure emergencies. Options for innovative designs, including registry-based studies, are also discussed in situations where randomized controlled trials are unfeasible. SIGNIFICANCE/CONCLUSIONS:The updated guideline reflects the changing scenario in epilepsy treatment development, with a greater focus on pediatric epilepsies, rare epilepsies, and other indications with high unmet needs. The updates also reflect the contribution during the consultation process by a wide range of stakeholders, including the ILAE Task Force on Regulatory Affairs.

OBJECTIVE:To evaluate whether the risk of long COVID among individuals infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) during pregnancy differs from that of individuals who were not pregnant at time of virus acquisition. METHODS:We conducted a multicenter observational cohort study at 79 NIH RECOVER (Researching COVID to Enhance Recovery) sites. Individuals assigned female at birth aged 18-45 years with an index (first) SARS-CoV-2 infection on or after December 1, 2021, were included. The exposure was pregnancy (any gestational age) at the time of index SARS-CoV-2 infection. The primary outcome was long COVID 6 months after index infection , defined as RECOVER-Adult Long COVID Research Index score 11 or higher based on a detailed symptom survey. To account for confounding and differential selection between participants who were pregnant and not pregnant at infection, propensity score-matching methods were used to balance the groups on variables potentially associated with both pregnancy status and long COVID. RESULTS:Overall 2,423 participants were included; 580 (23.9%) were pregnant at index SARS-CoV-2 infection. The median age at infection was 33 years (interquartile range 28-38 years), and 2,131 of participants (90.0%) with known vaccination status were vaccinated. After propensity score matching, the adjusted long COVID prevalence estimates 6 months after index infection were 10.2% (95% CI, 6.2-14.3%) among those pregnant at infection and 10.6% (95% CI, 8.8-12.4%) among those not pregnant at infection. Pregnancy was not associated with a difference in adjusted risk of long COVID (adjusted risk ratio 0.96, 95% CI, 0.63-1.48). CONCLUSION/CONCLUSIONS:Acquisition of SARS-CoV-2 during pregnancy was not associated with a differential risk of long COVID at 6 months compared with similar-aged individuals who acquired SARS-CoV-2 outside of pregnancy.