Faculty Bibliography

INTRODUCTION/BACKGROUND:Menu labels were federally mandated in May 2018, but the authors are not aware of any work that has evaluated the impact of the national rollout of this legislation in restaurants using a comparison group to account for potential bias. METHODS:Using synthetic control methods, Taco Bell restaurants that implemented menu labels after nationwide labeling (n=5,060 restaurants) were matched to restaurants that added calorie labels to menus after local labeling legislation (and prior to nationwide labeling). The effect of menu labeling on calories purchased per transaction after nationwide labeling between groups (i.e., "later-treated" and "early-treated" restaurants) was estimated using a two-way fixed effects regression model, with time modeled as relative month from implementation and fixed effects for calendar month and restaurant. RESULTS:In the baseline period, average calories per transaction was 1,242 (SD=178) in the national menu labeling group and 1,245 (SD=183.9) in the comparison group, with parallel trends between groups. Difference-in-differences model results indicated that transactions from restaurants in the national menu labeling group included 7.4 (95% CI: 7.3, 7.5) more calories than was predicted based on the trend in the comparison group. Average number of total transactions per month decreased ∼2% more in the national menu labeling group relative to the comparison group. CONCLUSIONS:Negligible changes were observed in calories purchased and number of transactions in restaurants that added calorie labels due to national legislation, above and beyond secular changes. Other strategies may be necessary to promote meaningful decreases in daily calories purchased in restaurants going forward.

Liver transplant (LT) recipients experience a wide range of comorbidities, leading to frequent healthcare encounters. Until now, national registries, which have limited exposures and outcomes, and laborious small cohort studies have been the main data sources for LT research. Cosmos database offers electronic health record (EHR)-based insights into LT recipients at the national level with granular data. We evaluated if Cosmos data is representative of the entire US LT recipient population. Using Cosmos (N=20,235) and the national Scientific Registry of Transplant Recipients (SRTR) (N=51,281), we identified adult, first-time LT recipients between 7/2016-12/2022. We compared demographics, clinical data, and mortality across datasets, calculating Kaplan-Meier survival estimates and multi-variable Cox regressions. Recipient characteristics were highly comparable (e.g., female: Cosmos=36.5% vs. SRTR=36.4%, Black: 6.8% vs. 7.2%; BMI: 28.5 kg/m2 [24.8-32.9] vs. 28.2 [24.6-32.4]). Lab values were similar across cohorts, including MELD (24 [17-30] vs. 23 [16-30]). Transplant indications, donor characteristics, and 5-year survival (Cosmos 83.1% [82.3-83.8) vs. SRTR 80.9% [80.4-81.3]) were similar. The associations of clinical factors with survival were similar across both groups. Cosmos database demonstrated acceptable generalizability to the general US LT recipient population, which may advance LT research through a better understanding about LT recipients' experiences and outcomes.

OBJECTIVES/UNASSIGNED:Caregivers may experience treatment burden as they care for persons living with dementia and diabetes. This study aims to adapt and validate the Treatment Burden Questionnaire (TBQ) for use among caregivers. METHOD/UNASSIGNED: = 311). The original patient-focused 15-item TBQ scale was adapted to measure caregiver-related burden. We assessed face validity for each item, performed item analysis, and computed the scale's internal consistency (Cronbach alpha). We also performed principal component analysis (PCA) and correlation to assess the construct and convergent validity, respectively. RESULTS/UNASSIGNED:All 15 items in the caregiver TBQ demonstrated face validity, had high acceptability, with a Cronbach alpha of 0.89. The PCA identified three domains-medication monitoring burden, healthcare access burden, and social care burden. Subscale domain reliability was 0.86, 0.77, and 0.77, respectively. The three subscales exhibited significant small to moderate correlations with the stress thermometer, Medical Outcomes Study, and physical and mental health Patient-Reported Outcomes Measurement Information System scores. CONCLUSION/UNASSIGNED:The caregiver TBQ is a reliable and valid tool that captures domains of medication monitoring, healthcare access, and social care burden.

INTRODUCTION/BACKGROUND:In Africa, 75% of households are exposed to household air pollution (HAP), a key contributor to cardiovascular disease (CVD). In Nigeria, 90 million households rely on solid fuels for cooking, and 40% of adults have hypertension. Though clean fuel and clean stove (CF-CS) technologies can reduce HAP and CVD risk, their adoption in Africa remains limited. METHODS AND ANALYSIS/METHODS:Using the Exploration, Preparation, Implementation and Sustainment framework, this cluster-randomised controlled trial evaluates the implementation and effectiveness of a community mobilisation (CM) strategy versus a self-directed condition (i.e., receipt of information on CF-CS use without CM) on adoption of CF-CS technologies and systolic blood pressure (SBP) reduction among 1248 adults from 624 households across 32 peri-urban communities in Lagos, Nigeria. The primary outcome is CF-CS adoption at 12 months; secondary outcomes are SBP reduction at 12 months and sustainability of CF-CS use at 24 months. Adoption is assessed via objective monitoring of stove usage with temperature-triggered iButton sensors. SBP is assessed in 2 adults per household using validated automated blood pressure monitor. Generalised linear mixed-effects regression models will be used to assess study outcomes, accounting for clustering at the level of the peri-urban communities (unit of randomisation) and households. To date, randomisation is completed, and a total of 1248 households have enrolled in the study. The final completion of the study is expected in June 2026. ETHICS AND DISSEMINATION/BACKGROUND:The study was approved by the Institutional Review Boards (IRB) of NYU Grossman School of Medicine (primary IRB of record; protocol ID: i21-00586; Version 6.0 approved on 4 June 2024), and Lagos State University Teaching Hospital (protocol ID: LREC 06/10/1621). Written consent was obtained from all participants. Findings will inform scalable and culturally appropriate strategies for reducing HAP and CVD risk in low-resource settings. Results will be disseminated through peer-reviewed publications, conference presentations and stakeholder engagements. TRIAL REGISTRATION NUMBER/BACKGROUND:NCT05048147.

BACKGROUND:Measurement-based care (MBC), including remote MBC, is increasingly being considered or implemented for mental health treatment and outcomes monitoring in routine clinical care. However, little is known about the health equity implications in real-world practice or the impact on patient-provider relationships in lower-resource systems that offer mental health treatment for diverse patients. OBJECTIVE:This hypothesis-generating study examined the drivers of MBC implementation outcomes, the implications for health equity, and the impact of MBC on therapeutic alliance (TA). The study was conducted 1 year after the implementation of remote MBC at 3 outpatient adult clinics in a diverse, safety-net health system. METHODS:This explanatory sequential mixed methods study used quantitative surveys and qualitative focus groups with mental health care providers. Repeated surveys were first used to understand mental health care provider experiences over a 6-month period, at least 1 year after MBC implementation. Surveys were analyzed to refine focus group prompts. Six mental health providers participated in repeated surveys over 6 months, after which the same 6 providers and 1 additional mental health provider took part in focus groups. RESULTS:Surveys revealed stable acceptability and utility ratings, concerns that MBC was not equally benefiting patients, little endorsement that MBC improved TA, and slightly decreasing feasibility scores. In focus groups, mental health care providers shared concerns about the acceptability, appropriateness, feasibility, and equity of processes for collecting MBC data. These providers had less first-hand experience with sharing and acting upon the data but still voiced concerns about the processes for doing so. TA both impacted and was impacted by MBC in positive and negative ways. The potential drivers of the findings are discussed using qualitative data. CONCLUSIONS:More than 1 year after the implementation of remote MBC for mental health, mental health care providers had enduring concerns about its implications for health equity as well as its bidirectional relationship with TA. These findings suggest that further study is needed to identify system-level strategies to mitigate potential negative effects of real-world MBC implementations on health equity, particularly in low-resource settings with diverse populations.

UNLABELLED:To explore how early cancers can be detected prior to clinical signs or symptoms, we assessed prospectively collected serial plasma samples from the Atherosclerosis Risk in Communities study, including 26 participants diagnosed with cancer and 26 matched controls. At the index time point, 8 of these 52 participants scored positively with a multicancer early detection test. All eight participants were diagnosed with cancer within 4 months after blood collection. In six of these eight participants, we were able to assess an earlier plasma sample collected 3.1 to 3.5 years prior to clinical diagnosis. In four of these six participants, the same mutations detected by the multicancer early detection test could be identified but at 8.6- to 79-fold lower mutant allele fractions. These results demonstrate that it is possible to detect ctDNA more than 3 years prior to clinical diagnosis and provide benchmark sensitivities required for this purpose. SIGNIFICANCE/UNASSIGNED:Earlier detection is a promising strategy to reduce cancer mortality. For cancers of all stages, therapies are more effective with a lower disease burden. In this study, we demonstrate that ctDNA is detectable 3 years or more before cancer diagnosis and provide estimates for the sensitivity required to achieve such very early detection. See related commentary by Crisafulli et al., p. 1774.

BACKGROUND:Glucagon-like peptide-1 (GLP-1) medications, recently introduced in the United States for treating type 2 diabetes and obesity, have sparked interest and discussion on social media. Social media has emerged as a prominent platform for the distribution of health information; its vast user base and accessibility make it a popular resource for individuals seeking medical advice. This study characterized GLP-1 medication-related content on Instagram about 3 critical areas of public health: women's health, access from nontraditional settings, and barriers to access. OBJECTIVE:This study aimed to perform passive content analysis in which information patterns would be observed from Instagram posts. METHODS:We examined 40 GLP-1 medication-related Instagram posts to develop a list of the most frequently used hashtags. In total, 10 "top posts" were collected for 7 days (July 11-17, 2023) for 11 study hashtags (eg, #Ozempic). Duplicates, deleted posts or accounts, non-English content, and unrelated posts were removed. Each post was reviewed by at least 2 coders. Coding discrepancies were resolved through discussion. RESULTS:The final sample included 239 posts. More than half of the posts (130/239, 54%) were from GLP-1 medication users. Raters perceived most users to be female (90/97, 92.8%); inferred that most used medications for weight loss (69/130, 53.1%); determined the most frequently noted health condition was polycystic ovarian syndrome (25/130, 19.2%); and judged posts to have positive sentiments about well-being (64/130, 49.2%) and toward the medications (100/130, 76.9%). About a quarter of the posts (55/239, 23%) offered services for obtaining GLP-1 medications; GLP-1 medications were perceived to be accessible via nontraditional health care settings (eg, medical spas) versus traditional settings (39/239,16.3% vs 12/239, 5%). Most users (78/97, 80.4%) were perceived to be White; barriers to access (ie, shortages, insurance, and cost) were infrequently mentioned (6/239, 2.5%; 3/239, 1.3%; and 1/239, 0.4%, respectively). CONCLUSIONS:Our findings highlight the perceived benefits of GLP-1 medications for women's health, the need to increase health literacy about where to safely access medications, and how additional attention is needed for equitable access to GLP-1 medications. The onus is on social media companies to promote content that is safe and for the health care system and its payers to address health care inequities for historically marginalized communities.

Findings for greenspace's impacts on birth outcomes are largely dependent on vegetation indexes. Examinations are needed for various greenspace indicators given varying pathways for fetal development. This prospective cohort study assessed the impacts of prenatal greenspace exposure on preterm birth (PTB), term low birthweight (TLBW), birthweight, and estimated fetal weight (EFW) for pregnant women in the New York City area, 2016-2023 (n=2765). Longitudinal greenspace exposure was measured for residential histories during pregnancy using the Enhanced Vegetation Index (EVI) for 1000m buffers and four park metrics, namely, the total number, sum of area, and the accessibility of parks within residential buffers (500 m) and the distance to the closest park. Multivariable regression models were used to estimate the associations for quartiles of exposure (with the first quartile [Q1] as reference). Greenspace exposure was not associated with TLBW, birthweight, or EFW. Odds ratios of PTB for the Q2, Q3, and Q4 EVI exposure groups compared to the Q1 group were 0.65 (95% CI: 0.43-0.98), 0.51 (0.32-0.80), and 0.56 (0.35-0.90), respectively. PTB risks decreased in higher exposure groups (Q2-Q4) of the total park number. Results indicate the benefits of prenatal greenspace exposure for fetal maturity and neonatal outcomes.

In 1992, Wacholder and colleagues developed a theoretical framework for case-control studies to minimize bias in control selection. They described three comparability principles (study base, deconfounding, and comparable accuracy) to reduce the potential for selection bias, confounding, and information bias in case-control studies. Wacholder et al. explained how these principles apply to traditional sources of controls for case-control studies, including population controls, hospital controls, controls from a medical practice, friend or relative controls, and deceased controls. The goal of the current manuscript is to extend this seminal work on case-control studies by providing a modern perspective on sources of controls. Today, there are many more potential sources of controls for case-control studies than there were in the 1990s. This is due to technological advances in computing power, internet access, and availability of 'big data' resources. These advances have vastly expanded the quantity and diversity of data available for case-control studies. In this manuscript, we discuss control selection from electronic health records, health insurance claims databases, publicly available online data sources, and social media-based data. We focus on practical considerations for unbiased control selection, emphasizing the strengths and weaknesses of each modern source of controls for case-control studies.