Faculty Bibliography

BACKGROUND:Visual evoked potential (VEP) P100 latency is routinely used to assess optic nerve demyelination. However, there is no established methodology for disentangling whether shifts in VEP P100 latency may reflect upstream changes in the visual pathway, such as the level of the retina, or whether these delays could be reflective of downstream disturbances in broader brain structure and functioning. OBJECTIVE:To determine the relationship between VEP-based P100 and MRI-based outcomes in people with MS (PwMS) after accounting for structural retinal changes assessed by spectral domain optical coherence tomography (OCT). METHODS:64 study participants underwent OCT, VEP, and MRI. Standardized VEP assessment derived monocular P100 latency for both eyes. Similarly, OCT performed on Heidelberg Spectralis hardware provided peripapillary retinal nerve fiber layer (pRNFL) thickness. Mediation analyses were performed to assess the relationship between P100 and MRI-based outcomes, adjusting for mediating effects of pRNFL and age. RESULTS:VEP-based P100 was significantly associated with lower whole brain volume (WBV) (p=0.0037), with 87.8% of the total effect being both direct and independent from RNFL and the significant age-WBV covariate effect. Similarly, greater VEP-based P100 latency was directly and independently predictive of lower gray matter volume (GMV) (p=0.015) and greater T2-FLAIR LV (p=0.0036) after adjusting for RNFL and age mediating effects. CONCLUSION/CONCLUSIONS:VEP-based P100 latency shows both age- and RNFL-independent associations with MRI-based MS outcomes. In addition to their established diagnostic utility, VEP measures may provide a neurophysiological, objective metric to assess neurodegeneration.

BACKGROUND:Family caregivers of people living with Lewy body dementia (PLBD) experience significant strain and adverse health outcomes that consequently affect the health of their loved ones with Lewy Body Dementia (LBD). Effective LBD caregiver interventions are needed. Building on pilot work, our objective is to test the effects of PERSEVERE (Peer Mentor Support and Caregiver Education)- a 12-week peer mentor-supported, LBD-specific educational intervention -on caregiver knowledge, attitudes, strain, and PLBD quality of life and healthcare utilization in a national, virtual, randomized controlled trial. METHODS:Partnering with LBD caregiver advisors and advocacy organizations, we are recruiting and enrolling 180 seasoned caregivers (having cared for a PLBD with ≥3 years of cognitive symptoms) and 502 novice LBD family caregivers (<3 years of cognitive symptoms). Seasoned caregivers train as Mentors. Novice caregivers are randomized 1:1 in cohorts of 100 to (1) the Mentee group receiving weekly Mentor calls covering a novel LBD curriculum focused on symptom management, future planning, and caregiver support, or (2) the attention-control group receiving pre-existing resources for self-directed learning. Primary outcomes include change from baseline in caregiver knowledge and attitudes at 12 weeks (post-intervention) and caregiver strain at nine months (follow-up). Secondary outcomes include engagement with materials and/or mentor, satisfaction, future interest, and change in PLBD quality of life and PLBD healthcare utilization at nine months. DISCUSSION/CONCLUSIONS:A peer mentor-delivered LBD-focused curriculum may improve caregiver and PLBD outcomes in a cost-effective, scalable manner. PERSEVERE has experienced robust national enrollment and retention within the first 18 months of recruitment, with outcomes forthcoming. Trial Registration https://clinicaltrials.gov/study/NCT06389032, registered on April 24, 2024.

RATIONALE AND OBJECTIVES/OBJECTIVE:There are over one thousand FDA-authorized radiology artificial intelligence (AI) devices, but prior analyses have addressed single device subtypes or single regulatory dimensions rather than the entire cohort. We characterized these devices by function, clinical application, manufacturer segment, and regulatory features. METHODS:We included 1094 radiology AI devices from the FDA AI-Enabled Medical Devices list authorized through December 2025, classified by functional category, computer-aided detection subtype when applicable, clinical use case, and manufacturer segment (original equipment manufacturer [OEM] versus non-OEM). Regulatory features included FDA review time, predetermined change control plan (PCCP) authorization, and AI predicate citation. Comparisons used chi-square, Wilcoxon rank-sum, and Kruskal-Wallis tests. RESULTS:Despite a 42% rise in annual authorizations from 2023 to 2025, functional composition remained stable: medical image management/processing systems (38.2%) and imaging systems (33.4%) predominated, and interpretive tools accounted for 21.5%. Among non-dental interpretive devices, cardiothoracic imaging and neuroradiology rose from 42% of authorizations before 2020 to 70% during 2023-2025; multi-finding devices rose from 3.8% to 18.3% (P=.03). OEM versus non-OEM devices differed in functional composition, median review time (118 vs 138 days; P<.001), PCCP authorization (1.5% vs 4.2%; P=.02), and primary AI predicate citation (44.8% vs 74.1%; P<.001), with a larger OEM predicate gap (32.9% vs 10.6%; P<.001). PCCP authorization rose from 0.8% (2020-2023) to 8.7% (2025). CONCLUSION/CONCLUSIONS:FDA-authorized radiology AI has grown rapidly while maintaining stable functional composition, with interpretive devices concentrated in cardiothoracic imaging and neuroradiology, distinct regulatory profiles between OEM and non-OEM manufacturers, and increasing PCCP authorization.

OBJECTIVE:To test 2 strategies designed to enhance primary care-based literacy promotion (LP): (1) text message reminders (texts), and (2) texts plus referral to community resources. METHODS:We recruited 630 Latino caregiver-infant (aged 6 to 12 months) dyads for an effectiveness-implementation hybrid type 1 randomized trial. Dyads were randomly assigned into (1) LP-only (Reach Out and Read), (2) LP plus text messages (LP+texts), or (3) LP+texts plus referral to Connecting New Jersey (CNJ) (LP+texts+CNJ), which streamlines access to community resources based on the national Help Me Grow model. Participants completed online surveys and assessments at enrollment, and 9 and 18 months after enrollment. Primary outcomes focused on 3 domains: child language and social-emotional development, and parenting behaviors, including reading and verbal responsiveness. We followed the intent-to-treat principle and used step-down minimum P value method to adjust for multiple comparisons. RESULTS:Among caregivers, 74% had less than or equal to a high school diploma and 88% reported speaking English less than very well. At 18 months after enrollment, the LP+text arm [effect size (ES) = 0.391; adjusted (adj.) P = .001] but not LP+text+CNJ had higher language scores compared with LP-only. At 9 and 18 months after enrollment, the LP plus texts plus CNJ arm had higher scores on social-emotional development than LP-only (ES = 0.267; adj. P = .04 and ES = 0.300; adj. P = .03, respectively), whereas the LP+text arm did not. At 9 months after enrollment, scores were higher for the LP+text+CNJ arm on verbal responsiveness (ES = 0.400; adj. P < .001) and the LP+text arm on reading (ES = 0.415; adj. P = .002) compared with LP-only. CONCLUSION/CONCLUSIONS:Two strategies with high potential for scale enhanced LP's ability to promote relational and developmental health. Clinicians and policymakers can use this knowledge to optimize LP's impact.

DESCRIPTION/UNASSIGNED:A work group representing the U.S. Department of Veterans Affairs (VA) and U.S. Department of Defense (DoD) prepared a new VA/DoD clinical practice guideline (CPG) for tobacco use treatment. This article provides a synopsis of the 2026 CPG, which addresses use of commercially available tobacco and nicotine products. METHODS/UNASSIGNED:A multidisciplinary work group developed 19 key questions on clinical topics of highest priority for the VA and DoD populations. Published literature from 1 January 2014 to 10 December 2024 was systematically reviewed using the PICOTS (population, intervention, comparator, outcomes, timing of outcomes measurement, and setting) framework. Recommendations were made by consensus and informed by evaluation using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) method, which assesses quality of evidence and balances benefits and harms, patient preferences, and feasibility. The final document incorporated input from peer review by an external group of experts. RECOMMENDATIONS/UNASSIGNED:The 2026 guideline includes 32 recommendations across 10 topic areas. Key recommendations for increasing abstinence from combustible tobacco include recommending motivational interviewing to increase engagement in treatment of tobacco and nicotine use (strong) and use of U.S. Food and Drug Administration-approved pharmacotherapies (strong), with varenicline recommended over monotherapy with other agents (strong), combination nicotine replacement therapy ([NRT] for example, patch plus lozenge) recommended over NRT monotherapy (single agent) (strong), and extending use of bupropion sustained release beyond 12 weeks (weak). Other key recommendations include varenicline for increasing abstinence from smokeless tobacco (strong) and electronic nicotine delivery systems (weak) and use of NRT or varenicline to increase quit attempts and abstinence in patients not ready to quit in the next 30 days (weak).

Type 2 diabetes is a risk factor for cardiac arrhythmias, but it is unknown how specific aberrations in glucose (e.g., episodes of high or low glucose) might contribute to the occurrence of heart rhythm abnormalities. The overarching goal of this study is to address research questions regarding how glucose patterns might contribute to the occurrence of arrhythmias, primarily atrial fibrillation, in adults with diabetes. To fulfill this goal, the Atherosclerosis Risk in Communities (ARIC) Gen2 study recruited 507 community-dwelling adults aged 50-80 years with type 2 diabetes to wear continuous glucose monitoring (CGM) and electrocardiogram (ECG) "patch" monitoring sensors simultaneously for up to 14 days. Gen2 study had high CGM and ECG completeness: the median wear time for sensors was 14 days and approximately 80% of participants wore both sensors for ≥10 days. By combining Gen2 and data from the original ongoing ARIC cohort (aged 80+), we have the capacity to conduct a comprehensive evaluation of the impact of CGM-defined glucose patterns on arrhythmias across a wide age spectrum from middle-aged to very old adults (aged 50-100) with type 2 diabetes. The findings from this study may help inform clinical strategies for the prevention and management of arrhythmias among adults with type 2 diabetes.

INTRODUCTION/UNASSIGNED:Associations between unhealthy food environments and increased risk of diabetes or obesity have been studied extensively in urban areas but less so in rural areas. To address this gap, we performed a geographically detailed study of the rural food environment, summarizing and assessing various measures and identifying their association with a higher rate of diabetes and obesity. METHODS/UNASSIGNED:We surveyed 1,311 residents of Sullivan County, New York, collecting data on demographic characteristics and health status in January 2021. We assessed the food environment by cataloging restaurants and retail food stores and used least absolute shrinkage and selection operator (LASSO) regression to identify metrics strongly associated with diabetes and obesity (body mass index >30.0). We compared absolute proximity, density, relative proportions, and modified retail food environment index metrics. We applied fixed distance bands and nearest-neighbor approaches for proportions. RESULTS/UNASSIGNED:Older age (LASSO = +0.276), nearest-neighbor proportion of fast food restaurants (LASSO = +0.155), and low income (LASSO = +0.150) were associated with higher diabetes rates. Nearest-neighbor proportion (LASSO = +0.269), density per square mile of groceries/supermarkets (LASSO = +0.247), and Hispanic ethnicity (LASSO = +0.181) were the strongest predictors of obesity. Nearest-neighbor metrics helped with the problem of frequent zeros: the least skewed measures were fast food restaurants with 20 nearest neighbors (P = .37 for skewness) and counter-service restaurants with 20 nearest neighbors (P = .81). CONCLUSION/UNASSIGNED:Nearest-neighbor approaches were less skewed to other metrics based on fixed distance bands, proximity, and density. Food environment metrics must be fully described and validated, especially in rural environments, before they are applied in research on critical health outcomes.

BACKGROUND:Cannabis use among older adults (≥ 65) in the US has increased substantially in recent years. However, physiologic changes associated with aging can complicate cannabis' effects in older populations, particularly as different modes of consumption have distinct pharmacokinetic effects. This study estimates the prevalence of different modes of cannabis use in this population and examines their associations with mental health outcomes. METHODS:We analyzed data from older adults aged ≥ 65 years with past-year cannabis use (N = 1515) from the pooled 2022-2024 National Survey on Drug Use and Health, a nationally representative survey of noninstitutionalized US adults. Four generalized linear models using Poisson and log link examined relationships between modes of cannabis use and cannabis use disorder (CUD), major depressive episode (MDE), serious psychological distress (SPD), and suicidal ideation (SI). The modes examined included smoking, ingested forms (eating/drinking or taking pills), inhaled concentrates (vaping or dabbing), and other routes (use of oral drops/lozenges or topicals). The models adjusted for survey year, sociodemographic characteristics, past-year cannabis use frequency, and other past-year substance use. RESULTS:Smoking (66.0%) was the most common mode of cannabis use, followed by ingested forms (42.1%), inhaled concentrates (17.1%), and other routes (16.8%). Compared to males, females had higher prevalence of ingested forms and other routes, while males had higher prevalence of smoking and inhaled concentrates. In multivariable models, smoking (adjusted prevalence ratio [aPR] = 3.99; 95% CI: 1.92-8.28) and ingested forms (aPR = 1.46; 95% CI: 1.03-2.09) were associated with increased prevalence of CUD. No mode was associated with MDE, SPD, or SI. CONCLUSIONS:Among older adults, smoking and ingested forms were associated with CUD, whereas no mode was associated with depression, distress, or suicidal ideation. These findings may inform targeted screening and harm reduction strategies for adults aged ≥ 65 years using cannabis.

INTRODUCTION/UNASSIGNED:For the public to adopt health promoting behaviors widely, there has to be sufficient trust in the institutions that disseminate information on protective behaviors. However, when members of the public lose trust in formal information sources, many seek information from informal information sources. Identifying trusted informal messengers is key to restore trust and effectively promote public health. METHODS/UNASSIGNED:We conducted repeat surveys with young adults and older adults living in New York City public housing to assess who they consider a trusted source of COVID-19 information, as well as their protective behavior practices across a period of five weeks. We then examined the association between trusted sources and participant behavior. RESULTS/UNASSIGNED:Participants in both age groups showed the highest trust in doctors or healthcare providers. Associations with protective behavior existed across multiple information sources, but strongest associations for both age groups were seen in relation to trusting one's faith leader for information. DISCUSSION/UNASSIGNED:Although other sources of information were more frequently cited as trustworthy by participants, trust in one's faith leader was the strongest predictor of protective behavior practices.