Faculty Bibliography

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.

PURPOSE/OBJECTIVE:The ASPIRE trial evaluated frontline anastrozole, palbociclib, trastuzumab, and pertuzumab in patients with HR-positive, HER2-positive metastatic breast cancer (MBC). METHODS:This phase I/II trial enrolled patients with previously untreated, HR-positive, HER2-positive MBC. In Phase I, patients received escalating doses of palbociclib with trastuzumab, pertuzumab and anastrozole, using a 3 + 3 dose escalation design, and primary endpoint was maximum tolerated dose (MTD). Phase II followed an optimal Simon two-stage design where all patients received palbociclib at the MTD, plus anastrozole, trastuzumab, and pertuzumab and the primary endpoint was clinical benefit rate (CBR) in the first six months. Secondary endpoints included progression free survival (PFS), overall survival (OS) and safety. RESULTS:In Phase I, no dose limiting toxicities were observed at the 100mg (N = 3) or 125mg (N = 6) dose levels, and thus, 125mg was the MTD. An additional 23 patients were enrolled to Phase II, with a total of 29 patients in the response-evaluable population. The primary endpoint of CBR was 97% (N = 28; 95% CI: 82-99%). At a median follow-up of 45.3 months, median PFS was 24.9 months (95% CI: 17.2-44.8). Median OS was not reached at a follow-up of 39.4 months. Most common treatment-related adverse events (TRAEs) were neutropenia, leukopenia, diarrhea, and anemia. Grade 3-4 TRAEs occurred in 62% (N = 18) of patients and most were hematologic. CONCLUSIONS:The combination of anastrozole, palbociclib, trastuzumab, and pertuzumab demonstrated promising activity in this single-arm trial of patients with HR-positive, HER2-positive MBC and warrants further study in randomized trials. The regimen could provide a chemotherapy-free alternative.

BACKGROUND:Women have been underrepresented in peripheral artery disease revascularization trials. We aimed to analyze sex-specific outcomes after endovascular therapy (EVT) with stent implantation versus bypass surgery (BSx) in patients with symptomatic femoropopliteal peripheral artery disease, leveraging data from the REVIVE (Revascularization Strategies in Patients With Peripheral Arterial Disease Involving the Femoropopliteal Arteries) study. METHODS:The REVIVE study pooled individual patient data from 5 randomized controlled trials comparing EVT with stent implantation versus BSx. The primary end point was major adverse limb events, a composite of all-cause death, major amputation, or reintervention. Secondary end points included amputation-free survival, the individual components of major adverse limb events, and primary patency at 2 years. Early complications were defined as a composite of any bleeding, infection, or all-cause death within 30 days. RESULTS:<0.001 in men). CONCLUSIONS:Our analysis supports the efficacy and safety of EVT with stent implantation as an alternative to BSx in patients with symptomatic peripheral artery disease involving the femoropopliteal segment, regardless of sex.

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.

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.

BACKGROUND/UNASSIGNED:Multilevel interventions targeting patients, providers, and health systems improve hypertension outcomes, but little is known about how well they are implemented in resource-limited settings. This study evaluated the implementation fidelity of ALTA, a multilevel approach for hypertension management, supported by practice facilitation, across six primary care practices in a Federally Qualified Health Center (FQHC). METHODS/UNASSIGNED:patients' BP and goals. We used a multi-method approach to assess implementation fidelity (adherence, dose, quality, responsiveness, differentiation) guided by Proctor's Implementation Outcome's Framework. Data sources included a structured EHR-embedded tool, narrative reports, and interviews over 12 months. ALTA adaptations were tracked using the Framework for Reporting Adaptations and Modifications-Expanded. RESULTS/UNASSIGNED: = 46) highlighted the need for team support, ongoing practice facilitation, and feedback on patients' progress as factors affecting fidelity. CONCLUSIONS/UNASSIGNED:Implementation fidelity varied across the ALTA components and participating sites, with the greatest variability observed in delivery of the site-level components of identify and refer. Centralized components delivered by the nurse-led team (coach, document, monitor) were delivered consistently with high fidelity. Contextual factors like staffing and patient engagement shaped implementation success. CLINICAL TRIAL REGISTRATION/UNASSIGNED:ClinicalTrials.gov, NCT03713515.

Hepatitis B virus (HBV) mother-to-child transmission (MTCT) remains a major challenge in Uganda, where 43% of births occur at home, and access to timely birth dose (BD) vaccination is limited. We evaluated the impact of combining universal three-dose (3D) infant vaccination, targeted BD vaccination, and maternal antiviral treatment for high viral load (HVL) mothers on HBV prevalence among infants. In a prospective 18-month cohort study at five regional maternity hospitals, HIV-negative pregnant women were screened for HBsAg. HBsAg-positive mothers were stratified by HBV DNA into HVL (≥ 20,000 IU/mL), low viral load (LVL), or LVL on treatment. HVL mothers received Tenofovir Disoproxil Fumarate plus Lamivudine in the third trimester. Infants of HBsAg-positive mothers received BD vaccination within 24 h and the 3D pentavalent series; infants of HBsAg-negative mothers received the 3D series only. All infants were tested for HBsAg at nine months. Of 19,053 mothers screened, 3.46% were HBsAg-positive (n = 660). Among HVL mothers (n = 80), 96.3% initiated antivirals; none of their infants who received both BD and 3D tested HBsAg-positive. Among LVL mothers not on treatment (n = 558), the prevalence of infection at nine months was 0.4% despite full vaccination. No infections occurred among LVL mothers on treatment or among infants of HBsAg-negative mothers. Overall infant HBsAg prevalence was 0.19%, with an adjusted national estimate of 0.02%. Integrating maternal antiviral prophylaxis, targeted BD vaccination, and universal 3D vaccination achieved near-elimination of HBV MTCT in this setting. Nationally scaling this strategy could enable Uganda to meet the WHO target of less than 0.1% infant HBV prevalence before 2030 and serve as a model for other high-burden countries with significant rates of home births.