Racial and Ethnic Differences in Initiation of Menthol Tobacco Smoking and Subsequent Tobacco Use in the Population Assessment of Tobacco and Health Study, Waves 1-4 (2013-2018).

INTRODUCTION: Certain subpopulations in the United States are highly vulnerable to tobacco initiation and addiction, and elimination of disparities among those groups is crucial to reducing the burden of tobacco use. AIMS AND METHODS: This study evaluated the racial and ethnic differences in smoking initiation of menthol flavored cigarettes and cigars among never-users, and in subsequent tobacco use among new users of menthol-flavored products, using longitudinal data from waves 1-4 of the Population Assessment of Tobacco and Health Study. The outcomes of interest were new use of menthol-flavored products, and subsequent past 30-day and past 12-month cigarette and cigar smoking, irrespective of flavors, after initiation. RESULTS: The percentages of new users of menthol-flavored cigarettes and cigars at waves 2-4 were disproportionately higher in non-Hispanic black and Hispanic than in non-Hispanic white people. Adjusting for age and sex, black people who first used any menthol cigars had higher risk of past 30-day use of the same cigar category at the subsequent wave (adjusted risk ratio, aRR 1.48; 95% confidence interval [CI] 1.11 to 1.96) and past 12 months (aRR 1.74; 95% CI 1.55 to 2.63) compared to non-Hispanic white smokers. Black people who first used menthol-flavored cigarettes had marginally higher risk of subsequent past 30-day cigarette use (aRR 1.44; 95% CI 0.99 to 2.10) compared with their non-Hispanic white counterparts. CONCLUSIONS: This study shows that racial and ethnic differences exist in both initiation of menthol-flavored tobacco products and product-specific subsequent use after first using menthol-flavored products; black and Hispanic people have higher rates of initiation; black people also have higher rates of subsequent use. IMPLICATIONS: Use of menthol flavors in tobacco products is confirmed to be a contributor to large disparities in tobacco use; black and Hispanic people are more likely to maintain smoking through use of mentholated products than non-Hispanic white people. The findings suggest educational and regulatory actions on menthol-flavored tobacco products including restricting the selective marketing to vulnerable communities and banning characterizing flavors in cigarettes and cigars may reduce tobacco-related disparities and inform the Food And Drug Administration's evidence-based rulemaking process.

Privacy Concerns in Group Format Lifestyle Interventions for Obesity.

BACKGROUND: Group format weight loss interventions have benefits over individual format, but privacy concerns may limit their uptake. METHOD: In this study, adults with obesity and interest in losing weight were recruited nationally online and randomly assigned to view one of eight videos describing a hypothetical, group behavioral weight loss intervention. Based on three fully crossed factors, the videos varied on privacy features of intervention (present or not); matching participants to group based on weight loss barriers (matched or not); and intervention format (online or in-person). Participants rated their willingness to join, privacy concerns, and perceived effectiveness of these interventions. They further reported preference for individual or group format interventions and reason for preferences. RESULTS: Description of privacy features, matching of participants, and format did not affect willingness to join, privacy concerns, or perceived effectiveness of the intervention. Privacy concerns were associated with lower willingness to join and lower perceived intervention effectiveness, and greater social anxiety and weight stigma. More participants preferred individual over group format (40.1% vs 33.9%; 26% selected neither) and preference for individual format was associated with greater privacy concerns. CONCLUSION: Strategies to address privacy concerns in group-based interventions warrant further attention.

Where Is Air Quality Improving, and Who Benefits? A Study of PM2.5 and Ozone Over 15 Years.

In the United States, concentrations of criteria air pollutants have declined in recent decades. Questions remain regarding whether improvements in air quality are equitably distributed across subpopulations. We assessed spatial variability and temporal trends in concentrations of particulate matter with an aerodynamic diameter ≤2.5 µm (PM2.5) and ozone (O3) across North Carolina from 2002-2016, and associations with community characteristics. Estimated daily PM2.5 and O3 concentrations at 2010 Census tracts were obtained from the Fused Air Quality Surface Using Downscaling archive and averaged to create tract-level annual PM2.5 and O3 estimates. We calculated tract-level measures of: racial isolation of non-Hispanic Black individuals, educational isolation of non-college educated individuals, the neighborhood deprivation index (NDI), and percentage of the population in urban areas. We fitted hierarchical Bayesian space-time models to estimate baseline concentrations of and time trends in PM2.5 and O3 for each tract, accounting for spatial between-tract correlation. Concentrations of PM2.5 and O3 declined by 6.4 µg/m3 and 13.5 ppb, respectively. Tracts with lower educational isolation and higher urbanicity had higher PM2.5 and more pronounced declines in PM2.5. Racial isolation was associated with higher PM2.5 but not with the rate of decline in PM2.5. Despite declines in pollutant concentrations, over time, disparities in exposure increased for racially and educationally isolated communities.

SoS Notebook: an interactive multi-language data analysis environment.

Motivation: Complex bioinformatic data analysis workflows involving multiple scripts in different languages can be difficult to consolidate, share and reproduce. An environment that streamlines the entire processes of data collection, analysis, visualization and reporting of such multi-language analyses is currently lacking. Results: We developed Script of Scripts (SoS) Notebook, a web-based notebook environment that allows the use of multiple scripting language in a single notebook, with data flowing freely within and across languages. SoS Notebook enables researchers to perform sophisticated bioinformatic analysis using the most suitable tools for different parts of the workflow, without the limitations of a particular language or complications of cross-language communications. Availability and implementation: SoS Notebook is hosted at http://vatlab.github.io/SoS/ and is distributed under a BSD license.

North American Cancer Center Clinical Research Capacity and Benchmarking in the Postpandemic Era.

PURPOSE: Cancer center clinical trial offices (CCTOs) support trial development, activation, conduct, regulatory adherence, data integrity, and compliance. In 2018, the Association of American Cancer Institutes (AACI) Clinical Research Innovation (CRI) Steering Committee conducted and published survey results to benchmark North American CCTOs, including trial volume, accrual, full time equivalents (FTEs), and budget. The survey was readministered in 2023 to assess contemporary CCTO performance and capacity with results presented here. METHODS: The 28 question 2023 survey was sent to directors of AACI's clinical member cancer centers. Survey participation was voluntary, no compensation was provided, and data requested covered operations during 2022. Definitions were consistent with National Cancer Institute (NCI) CCTO reporting requirements and AACI staff anonymously compiled results for descriptive statistical reporting. RESULTS: The survey response rate was 61% (60/99). The median annual CCTO budget was $11.5 million (M) US dollars (USD) versus $8.2M USD in 2018. These budgets support a median of 150 FTEs versus 104 previously, and a median total of 384 versus 280 interventional treatment trials and a median of 479 versus 531 interventional treatment accruals. Sources of support for CCTO annual budgets were primarily from industry revenue (45.3%) or institutional support (31.7%). Nearly 60% of centers reported activating NCI-sponsored studies within 90 days but only 9% reported meeting a 90-day activation timeline for industry sponsored studies. CONCLUSION: Contemporary benchmarks for CCTO operations through this survey demonstrate larger staff sizes, larger budgets, more trials supported, but fewer patients enrolled to interventional treatment trials in comparison with 2018. These data shine a critical light on the increasing complexity of cancer clinical trials, the importance of external funding sources, and necessary operational efficiency upgrades to provide cutting-edge cancer research and care.

Feasibility and performance of continuous glucose monitoring in hyperglycemia after lung transplantation.

Background: Post-Transplant Diabetes Mellitus (PTDM) affects 20%-40% of lung transplant recipients within five years, impacting rejection, infection, cardiovascular events, and mortality. Continuous glucose monitoring (CGM) is used in diabetes but not well-studied in PTDM. Objective: This study assessed CGM performance in detecting hypoglycemia and hyperglycemia post-lung transplantation, compared to self-monitoring blood glucose. Methods: A prospective pilot study included 15 lung transplant patients (mean age 58.6 years; 53.3% men; 73.3% with pre-transplantation diabetes) managing hyperglycemia with insulin. Patients used a blinded CGM and self-monitored glucose for ten days. Data were categorized (% time in range, % high, % very high, % low, % very low) and compared using paired t-tests. Results: CGM showed superior hyperglycemia detection. Mean differences for "% very high", "% high", and "% high and % very high" were 7.12 (95% CI, 1.8-12.4), 11.1 (95% CI, 3.5-18.8), and 18.3 (95% CI: 7.37-29.24), respectively. No significant difference was found for "% low and % very low". All patients reported a positive CGM experience. Conclusion: CGM use post-lung transplantation seems feasible and offers advantages in detecting hyperglycemia and in optimizing glucose management. Study limitations include a small sample size, requiring larger studies to assess glycemic control, hypoglycemia detection, and transplant outcomes.

Pre-Enrollment Steps and Run-Ins in Weight Loss Trials: A Meta-Regression.

INTRODUCTION: The generalizability of study findings may be influenced by pre-enrollment trial procedures, including the use of behavioral run-in periods. The study goals were to determine whether behavioral run-in periods and other pre-enrollment processes affect outcomes in randomized trials of behavioral weight loss interventions that have contributed to clinical guidelines. METHODS: The sample was behavioral weight loss intervention trials included in the 2018 U.S. Preventive Services Task Force systematic review. Information on pre-enrollment processes (total steps, in-person steps, behavioral run-in) was abstracted, and meta-regressions were conducted in 2022 to test whether pre-enrollment processes were associated with weight loss at 6 or 12 months and trial retention at 12 months. RESULTS: Across 80 trials, the median number of total pre-enrollment steps was 2 (range=1-5), and that of in-person pre-enrollment steps was 1 (range=0-4). Almost one-third of the trials (k=24; 30%) used a behavioral run-in. The most common run-in tasks were self-monitoring physical activity (k=9) or both physical activity and diet (k=6). Greater weight loss was observed in trials with behavioral run-ins at 6 months (-2.33 kg; 95% CI= -3.72, -0.93) and, to an attenuated extent, at 12 months (-0.86 kg; 95% CI= -1.72, 0.01) compared to those without run-ins. The total number of pre-enrollment steps was also associated with greater 6-month weight loss (-0.85 kg; 95% CI= -1.59, -0.11). Higher retention was associated with total number of pre-enrollment steps and in-person steps and marginally with the presence of run-ins. DISCUSSION: The use of more pre-enrollment processes is associated with greater weight loss in behavioral weight loss trials and may impact the generalizability of outcomes.

The interleukin-1 axis and the tumor immune microenvironment in pancreatic ductal adenocarcinoma.

Interleukin-1 (IL-1) plays a key role in carcinogenesis and several IL-1-targeted therapeutics are under investigation for the treatment of pancreatic ductal adenocarcinoma (PDAC). We sought to broaden our understanding of how the family of IL-1 ligands and receptors impact the tumor immune landscape and patient survival in PDAC. Gene expression data and DNA methylation data for IL1A, IL1B, IL1RN, IL1R1, IL1R2, and IL1RAP was attained from The Cancer Genome Atlas (TCGA) database and cross validated using the National Center for Biotechnology Information (NCBI) Gene Expression Omnibus (GEO) database. Immune cell-type abundance was estimated using CIBERSORTx. Further confirmatory soluble protein analysis and peripheral blood immunophenotyping were performed on available tissue samples from our institution. 169 PDAC patients and 50 benign pancreatic TCGA-based samples were analyzed. IL1A (p < 0.001), IL1RN (p < 0.001), IL1R2 (p < 0.001), and IL1RAP (p = 0.006) were markedly increased in PDAC tumor tissue compared to benign pancreatic tissue. Furthermore, expression of IL1A, IL1B and IL1R1 were positively correlated with gene expression of immune checkpoints PVR, CD274, CD47, CD80, and HLA-A/B/C (p < 0.001). IL1B and IL1R1 were correlated to expression of PDCD1, CD86, CTLA4 and IDO1 (<0.001). Low expression of IL1RN (p = 0.020), IL1R2 (p = 0.015), and IL1RAP (p = 0.003) and high expression of IL1B (p = 0.031) were correlated with increased patient survival. At the protein level, IL-1ß was correlated with increased peripheral central memory CD4+ and CD8+ T-cells as well as decreased Th2 cells. These findings suggest that the IL-1 axis plays a complex and pivotal role in the host immune response to PDAC.

Assessing Disparity Using Measures of Racial and Educational Isolation.

We develop a local, spatial measure of educational isolation (EI) and characterize the relationship between EI and our previously developed measure of racial isolation (RI). EI measures the extent to which non-college educated individuals are exposed primarily to other non-college educated individuals. To characterize how the RI-EI relationship varies across space, we propose a novel measure of local correlation. Using birth records from the State of Michigan (2005-2012), we estimate associations between RI, EI, and birth outcomes. EI was lower in urban communities and higher in rural communities, while RI was highest in urban areas and parts of the southeastern United States (US). We observed greater heterogeneity in EI in low RI tracts, especially in non-urban tracts; residents of high RI tracts are likely to be both educationally and racially isolated. Associations were also observed between RI, EI, and gestational length (weeks) and preterm birth (PTB). For example, moving from the lowest to the highest quintile of RI was associated with a 1.11 (1.07, 1.15) and 1.16 (1.10, 1.22) increase in odds of PTB among NHB and NHW women, respectively. Moving from the lowest to the highest quintile of EI was associated with a 1.07 (1.02, 1.12) and 1.03 (1.00, 1.05) increase in odds of PTB among NHB and NHW women, respectively. This work provides three tools (RI, EI, and the local correlation measure) to researchers and policymakers interested in how residential isolation shapes disparate outcomes.