Faculty Bibliography

BACKGROUND:In patients with hormone receptor (HR)-positive early breast cancer (BC), the POSITIVE trial demonstrated that temporary interruption of adjuvant endocrine therapy (ET) for pregnancy is feasible and safe in early follow-up (median 41 months). In this article, we report updated results from a preplanned analysis with 2.5 years of additional follow-up. PATIENTS AND METHODS/METHODS:POSITIVE, a single-arm prospective trial evaluating temporary interruption of adjuvant ET (after 18-30 months and for up to 2 years) to attempt pregnancy in young patients with BC, enrolled 518 eligible women (≤42 years of age, stage I-III BC, desiring pregnancy) from December 2014 to December 2019. Using the bootstrap-matching method, 5-year breast cancer-free interval (BCFI) and distant recurrence-free interval (DRFI) event rates were compared with those of the SOFT/TEXT trials as external controls. RESULTS:At a median follow-up of 71 months in the POSITIVE cohort and 80 months in the SOFT/TEXT cohort, the 5-year cumulative incidence of BCFI events was 12.3% in POSITIVE and 13.2% in SOFT/TEXT [-0.9% difference, 95% confidence interval (CI) -4.2% to 2.6%]. The 5-year cumulative incidence of DRFI events was 6.2% and 8.3%, respectively (-2.1% difference, 95% CI -4.5% to 0.4%). Among 497 women followed for nondisease outcomes, 377 (76%) had ≥1 documented pregnancy on trial, and 343 of 497 (69%) had ≥1 live birth, totaling 440 offspring. In an unadjusted analysis comparing the 180 women (36%) who had pre-enrollment embryo/oocyte cryopreservation with those who did not, the 5-year cumulative incidence of BCFI events was 14.0% (95% CI 9.6% to 20.2%) and 11.5% (95% CI 8.4% to 15.7%), respectively. CONCLUSION/CONCLUSIONS:Longer-term follow-up of the POSITIVE trial demonstrates that temporary interruption of ET for pregnancy, including use of fertility preservation, does not increase the risk of BC events. Continued follow-up is warranted given the known risk of late recurrence in this population.

BACKGROUND:Anticancer treatments are associated with cutaneous adverse events (cAEs) that can severely impact patients' quality of life (QoL) and interfere with treatment outcomes. LACOM aims to support clinicians in preventing and managing cAEs to optimize patient outcomes. METHODS:A panel of dermatologists, clinical oncologists, and radiation oncologists developed an evidence-based algorithm for the prevention and treatment of cancer treatment-related cAEs using a skincare regimen that includes hygiene, moisturization, sun protection, and camouflage products. RESULTS:The LACOM II algorithm discusses patient education before cancer treatment, appropriate skincare, triage, and the importance of treating emerging cAEs with a multidisciplinary team. CONCLUSIONS:Integrating proactive education, safe and effective skincare, triage, and reaction-specific management of cAEs is essential to optimize the care of patients living with cancer. The LACOM II algorithm provides evidence- and opinion-based best-practice recommendations to support clinicians working with oncology patients throughout the continuum of care, achieving optimal outcomes and improving patients' QoL. &nbsp.

IMPORTANCE/UNASSIGNED:Remote patient monitoring (RPM), including self-measured blood pressure monitoring with clinician review and telehealth-supported feedback, can support hypertension management. However, RPM use and related care continuity after switching from Medicare fee-for-service (FFS) to Medicare Advantage (MA) remain unclear. OBJECTIVE/UNASSIGNED:To compare RPM adoption, clinician continuity, and hypertension-related acute care utilization among beneficiaries who remained in Medicare FFS vs switched to MA plans, categorized as value-based contract (VBC) proxy or non-VBC. DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:This cohort study with an observational difference-in-differences design with propensity score matching used data from 2016 to 2022 Medicare enrollment, FFS claims, and MA encounter data. Beneficiaries were aged 65 years or older with prevalent diagnosed hypertension in 2018 and continuous enrollment in Parts A and B in 2018. Treated groups switched from FFS to MA in January 2019 and remained enrolled through 2022; comparators remained in FFS. Follow-up extended from January 1, 2019, through December 31, 2022. Data analysis was conducted from April to July 2025. EXPOSURE/UNASSIGNED:Switching from Medicare FFS to MA-VBC proxy or MA non-VBC in 2019. MAIN OUTCOMES AND MEASURES/UNASSIGNED:The primary outcome was annual RPM adoption during hypertension-related visits; secondary outcomes included clinician loss without replacement, clinician switching or substitution, and hypertension-related emergency department (ED) visits and hospitalizations. RESULTS/UNASSIGNED:Matched samples included 281 620 beneficiaries, with 46 833 MA-VBC proxy plan switchers and 46 833 FFS comparators (27 920 [59.6%] aged 71 years or older and 27 685 female [59.1%] in each group) and 93 977 MA non-VBC switchers and 93 977 FFS comparators (67 188 [71.5%] aged 71 years or older; 53 122 female [56.5%] in each group). Common comorbidities included diabetes, chronic kidney disease, and heart failure. Switching to MA was associated with lower RPM adoption in 2022 (MA-VBC proxy: odds ratio [OR], 0.55; 95% CI, 0.42-0.72; -0.63 percentage points; non-VBC: OR, 0.73; 95% CI, 0.54-0.99; -0.52 percentage points), greater clinician loss without replacement (MA-VBC proxy: OR, 1.27; 95% CI, 1.23-1.32; 3.41 percentage points; MA non-VBC: OR, 1.09; 95% CI, 1.06-1.12; 0.83 percentage points), and higher hypertension-related hospitalizations (MA-VBC proxy: OR, 1.75; 95% CI, 1.48-2.06; MA non-VBC: OR, 1.94; 95% CI 1.71-2.19; 1.56 percentage points in both comparisons). Event-study analyses showed postswitch divergence through 2022. CONCLUSIONS AND RELEVANCE/UNASSIGNED:In this cohort study of older Medicare beneficiaries with hypertension, switching from FFS to MA was associated with lower RPM adoption, greater clinician discontinuity, and higher hypertension-related acute care use. These findings suggest that continuity safeguards and clearer payment or quality incentives during MA transitions may support remote monitoring and clinician follow-up for hypertension.

Pneumonia is one of the deadliest and most common infections worldwide. Traditional management has focused on pathogen-directed therapy with antimicrobial drugs. However, continued increase of antimicrobial resistance represents a growing health care crisis and heightens the urgency of shifting the treatment focus outside of the traditional paradigm. Adjunctive and host-directed therapies (HDT) target the response to infection by either enhancing the host immune response or mitigating immunopathology. They encompass a broad range of treatments, repurposed medications, and interventions that alter how the host responds to infections. This review summarizes adjunctive and HDTs for bacterial, tuberculous, fungal, and viral pneumonia.

INTRODUCTION/BACKGROUND:Patients with a suspected high-consequence infectious disease (HCID), such as Ebola virus disease, may require routine laboratory testing to guide management. We assessed the capabilities of frontline hospitals and the barriers they face performing laboratory testing for patients with a suspected HCID. METHODS:A one-time confidential REDCap survey querying capabilities to safely perform laboratory tests that the Centers for Disease Control and Prevention considers critical for patients with a suspected HCID was sent to 95 institutions in Baltimore, MD, Boston, MA, New York City, NY, and Washington, DC, from January to May 2025. RESULTS:Fifty (53%) institutions responded, mostly teaching hospitals (96%), with 24% reporting prior experience evaluating a patient with suspected Ebola virus disease. While many hospitals could perform on-site blood gas (70%), hemoglobin/hematocrit (68%), and lactate (68%) tests on a suspected HCID patient, fewer could safely perform a chemistry panel (64%), a urinalysis (60%), a complete blood count with differential (56%), and a malaria rapid diagnostic test (RDT) (48%) on a suspected HCID patient. The five tests respondents most often considered extremely or very important were hemoglobin/hematocrit (91%), chemistry panel (90%), CBC with differential and platelet count (89%), malaria RDT (88%), and blood gas (88%). Reported barriers to performing routine laboratory testing included issues related to patient and staff safety, infection control, lack of appropriate space, and funding. CONCLUSIONS:Our survey identified several barriers to implementing safe laboratory testing. The inability to conduct these laboratory tests may result in delays in care when an HCID is suspected.

Mistreatment of trainees in graduate medical education (GME) persists despite Accreditation College of Graduate Medical Education (ACGME) standards. Mistreatment disproportionately affects minoritized trainees and undermines their well-being and abilities to provide empathic patient care. The authors conducted a scoping review to identify existing structures-education/trainings and programs/policies-to mitigate harm from and address perpetrators of mistreatment, and to map gaps to guide practice and research. They searched PubMed and Embase for US-based, English-language studies (January 2015-July 2025). References were screened independently and in duplicate. Included studies described educational/training interventions or programs/policies, or proposed a structural approach focused on addressing mistreatment of trainees. Of 856 records, 71 studies (41 articles, 30 abstracts) were included: 56 education/trainings and 15 programs/policies. Trainings reached 3909 learners, were predominantly single-session, and commonly used case-based discussion, role-play, and simulation. Assessments relied largely on immediate self-report of knowledge, skills, or attitudes; few used objective measures or longitudinal follow-up. Programs and policies encompassed real-time reporting tools, communication campaigns, co-created protocols, and task forces all focused on addressing mistreatment after the fact. Outcomes included increased reporting volume of mistreatment, characterization of perpetrators, and identification of concentrated areas of mistreatment within the health system, trainee perceptions, and feedback loops. Mapping of the literature revealed many education/training interventions and fewer programs/policies. A significant gap remains because too strong a focus exists on teaching trainees-the targets of mistreatment-to manage the mistreatment after the fact, rather than implementing trainings and programs to proactively prevent learner mistreatment. The authors suggest opportunities including perpetrator-focused, non-punitive trainings, longitudinal skills reinforcement in the clinical learning environment, transparent measurement, and a continuous quality improvement approach to both preventing and recovering from mistreatment. Addressing mistreatment will require institutional policies and comprehensive, equity-informed structures with objective assessment, shifting focus from resilience after harm to prevention at its source.

This multicenter, prospective, randomized controlled trial (NCT03285152) evaluates the primary endpoint of feasibility of a very-low carbohydrate diet (VLCD) in 19 women with obesity/overweight and endometrial cancer, who are randomized 2:1 to either a VLCD or a standard diet for 21-28 days. Fifteen participants complete the study, with 91 ± 4% of VLCD meals consumed, 5.5 ± 0.8% weight lost, and no grade 3/4 adverse events. Secondary endpoints include assessments of tumor biology and circulating metabolic biomarkers. Fasting glucose and insulin fall 22 ± 5.9% and 60 ± 3.8%, while total cholesterol and low-density lipoprotein (LDL) rise 6 ± 2.7% and 17.8 ± 8.9%. In a pre-specified exploratory outcome, RNA-Seq shows enrichment of CD8 + T-cells (q < 0.034; NES > 1.75), confirmed by immunohistochemistry (IHC) showing CD8 + T-cells infiltration of the tumor margins (q = 0.034; NES = 1.75). We conclude that VLCD is feasible and well-tolerated.

PURPOSE/OBJECTIVE:To develop Trainee Attributable & Automatable Care Evaluations in Real‑Time (TRACERs) for inpatient diabetes management, collect validity evidence for their use in formative assessment, and explore performance variation across residents and institutions. METHOD/METHODS:In 2023, a multi‑institutional team created two TRACERs based on type 2 diabetes guidelines-discourage bolus‑only insulin (TRACER #1) and encourage basal (± bolus) insulin (TRACER #2)-for internal medicine residents at three large residency programs. Residents were attributed to inpatient admissions based on placing the most medication orders in the first 12 hours. Structured queries extracted 35 discrete variables from the electronic health record (EHR). Two experts per institution reviewed random admissions (July-August 2022) to establish criterion validity. A retrospective cohort (July 2020-June 2023) added validity evidence. RESULTS:Automated extraction achieved ≥96% sensitivity and ≥95% specificity when compared to manual review. Among 615 residents attributed to 6,192 admissions of patients with type 2 diabetes at high risk for hyperglycemia, TRACER #1 occurred in 42.6% (1,689/3,965) of admissions at Program A, 28.9% (408/1,410) at Program B, and 26.7% (218/817) at Program C. TRACER #2 occurred in 44.9% (367/817) of Program C admissions versus 24.2% (959/3,965) at Program A and 28.2% (397/1,410) at Program B (all P < .001). Four resident-level insulin‑ordering profiles were identified-consistent basal-bolus insulin use (most guideline-concordant), basal-predominant, bolus-predominant, and bolus-only (most guideline-discordant)-with between‑resident variation exceeding between‑program differences. Longitudinally, cohort-level trends masked opposing individual trajectories-some residents improved with exposure while others worsened-and performance tertiles were distinguishable early in training. CONCLUSIONS:TRACERs revealed substantial institution‑ and resident‑level variation in insulin‑ordering practices, including guideline deviations, demonstrating potential for real‑time formative feedback. Multi‑institutional implementation highlighted scalability barriers, including EHR heterogeneity and workflow‑dependent attribution, underscoring the need for continued refinement and broader validation.

Background A landmark study of 1,600 Italian-Americans in Roseto, PA, challenged the prevailing view that high saturated fat intake was a major cause of myocardial infarction (MI). Despite similar rates of cigarette smoking and obesity, and even higher levels of saturated fat consumption compared to neighboring towns, Rosetans experienced far lower MI death rates. More than 50 years later, it remains uncertain whether Roseto's residents had better heart health than the average American and, if so, what protective factors may have been responsible. Methodology We compared MI deaths in Roseto and neighboring towns to the contemporaneous Framingham Heart Study cohort matched for age and sex. Results We found no evidence that MI deaths were lower in Roseto, PA, than in Framingham, MA when controlling for age and sex. While the role of social support in health has been established in subsequent studies, methodological issues, confounding factors, and biases challenge the validity of the Roseto study. Conclusions The dramatically lower MI and MI mortality rates among males in Roseto reflect biases in sampling and comparison populations, which also impacted the contrasting Diet-Heart Hypothesis that saturated fats cause heart disease. Although social support enhances health outcomes, the Roseto study neither supported nor refuted this connection.