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John C Sieverdes, Xuemei Sui, Gregory A Hand, Vaughn W Barry, Sara Wilcox, Rebecca A Meriwether, James W Hardin, Amanda C McClain, Steven N BlairDepartment of Exercise Science, University of South Carolina, Columbia, SC, USAPurpose: This report examines the blood chemistry and blood pressure (BP) results from the Lifestyle Education for Activity and Nutrition (LEAN) study, a randomized weight loss trial. A primary purpose of the study was to evaluate the effects of real-time self-monitoring of energy balance (using the SenseWearTM Armband, BodyMedia, Inc Pittsburgh, PA) on these health factors.Methods: 164 sedentary overweight or obese adults (46.8 ± 10.8 years; BMI 33.3 ± 5.2 kg/m2; 80% women) took part in the 9-month study. Participants were randomized into 4 conditions: a standard care condition with an evidence-based weight loss manual (n = 40), a group-based behavioral weight loss program (n = 44), an armband alone condition (n = 41), and a group plus armband (n = 39) condition. BP, fasting blood lipids and glucose were measured at baseline and 9 months.Results: 99 participants (60%) completed both baseline and follow-up measurements for BP and blood chemistry analysis. Missing data were handled by baseline carried forward. None of the intervention groups had significant changes in blood lipids or BP when compared to standard care after adjustment for covariates, though within-group lowering was found for systolic BP in group and group + armband conditions, a rise in total cholesterol and LDL were found in standard care and group conditions, and a lowering of triglycerides was found in the two armband conditions. Compared with the standard care condition, fasting glucose decreased significantly for participants in the group, armband, and group + armband conditions (all P < 0.05), respectively.Conclusion: Our results suggest that using an armband program is an effective strategy to decrease fasting blood glucose. This indicates that devices, such as the armband, can be a successful way to disseminate programs that can improve health risk factors. This can be accomplished without group-based behavioral programs, thereby potentially reducing costs.Keywords: armband, energy balance, randomized controlled trial, physical activity, blood lipids, blood glucose

Data from a study concerning retention interval and school-meal observation on children's dietary recalls were used to investigate relationships of social desirability score (SDS) and body mass index percentile (BMI%) to recall accuracy for energy for observed (n = 327) children, and to reported energy for observed and unobserved (n = 152) children. Report rates (reported/observed) correlated negatively with SDS and BMI%. Correspondence rates (correctly reported/observed) correlated negatively with SDS. Inflation ratios (overreported/observed) correlated negatively with BMI%. The relationship between reported energy and each of SDS and BMI% did not depend on observation status. Studies utilizing children's dietary recalls should assess SDS and BMI%. Copyright © 2010 SAGE Publications [ABSTRACT FROM AUTHOR]

-- The Clinical Nurse Leader (CNL) role was designed to meet an identified need for expert clinical leadership at the point of care.-- The Veterans Health Administration (VHA) became early adopters of the CNL role, foreseeing the value of this pivotal clinical leader at the point of care to meet the complex health care needs of America's ve t e rans and shape health care delivery.-- Impact data were collected and assimilated from seven Veterans Administration Medical Centers to support how CNLs impact the delive ry of quality and safe patient care and how practice changes could be sustained.-- Data collection and analyses resulted in many lessons learned.-- The new CNL role was implemented in a va riety of settings in the VHA system.-- Integration of the CNL role in all areas of practice in every care setting has the promise of streamlining coordination of care for veterans across all spectrums in the provision of care. [ABSTRACT FROM AUTHOR]

Objective: To compare two approaches to analysing energy- and nutrient-converted data from dietary validation (and relative validation) studies - conventional analyses, in which the accuracy of reported items is not ascertained, and reporting-error-sensitive analyses, in which reported items are classified as matches (items actually eaten) or intrusions (items not actually eaten), and reported amounts are classified as corresponding or overreported.Design: Subjects were observed eating school breakfast and lunch, and interviewed that evening about that day's intake. For conventional analyses, reference and reported information were converted to energy and macronutrients; then t-tests, correlation coefficients and report rates (reported/reference) were calculated. For reporting error-sensitive analyses, reported items were classified as matches or intrusions, reported amounts were classified as corresponding or overreported, and correspondence rates (corresponding amount/reference amount) and inflation ratios (overreported amount/reference amount) were calculated.Subjects: Sixty-nine fourth-grade children (35 girls) from 10 elementary schools in Georgia (USA).Results: For energy and each macronutrient, conventional analyses found that reported amounts were significantly less than reference amounts (every P < 0.021; paired t-tests); correlations between reported and reference amounts exceeded 0.52 (every P < 0.001); and median report rates ranged from 76% to 95%. Analyses sensitive to reporting errors found median correspondence rates between 67% and 79%, and that median inflation ratios, which ranged from 7% to 17%, differed significantly from 0 (every P < 0.0001; sign tests).Conclusions: Conventional analyses of energy and nutrient data from dietary reporting validation (and relative validation) studies may overestimate accuracy and mask the complexity of dietary reporting error. [ABSTRACT FROM AUTHOR]

Objective: To investigate the effect of observing school meals on children's dietary reports.Subjects and Setting: One hundred and twenty children randomly selected, but with half girls, from usual school-meal eaters among 312 volunteers (from all 443 fourth-grade children in six schools in one district).Design: Children were assigned randomly to one of 12 conditions yielded by crossing observation status (observed; not observed), target period (previous day; prior 24 hours), and interview time (morning; afternoon; evening).Results: Response variables included interview length, number of meals and snacks reported for the target period, and, for two school meals, number of meal components reported, importance-weighted number of items reported and kilocalories reported. These variables were transformed to principal components; two were retained (1, the school meal variables; 2, interview length and number of meals and snacks). Analyses of variance on principal component scores tested effects of observation status, target period, interview time and all interactions. Observation status did not affect scores on either retained principal component. Scores on Component 2 showed that more intake was reported in prior-24-hours interviews than in previous-day interviews.Conclusions: The effect of target period on reported intake indicates that the response variables were sufficiently reliable to detect manipulations. This, together with the finding that response variables did not depend on observation status, suggests that observation of school meals does not affect fourth-grade children's dietary reports, and that conclusions about dietary reports by fourth-grade children observed eating school meals in validation studies may be generalised to dietary reports by comparable children not observed. [ABSTRACT FROM AUTHOR]

Women living with HIV are especially vulnerable to discrimination because of the stigma associated with the disease, as well as their race, gender and class status. To investigate the association between self-reported HIV discrimination and health outcomes among African- American and white women living with HIV, 366 women living with HIV were recruited from HIV/AIDS clinics in Georgia and Alabama. In this cross-sectional study, participants completed an interview that assessed self-reported HIV discrimination and depressive symptomatology, suicidal ideation, self-esteem, stress, quality of life, sexual health and HIV/AIDS related health care seeking. Nearly a sixth of the sample reported experiencing HIV discrimination. Women reporting HIV discrimination had higher mean scores for stress, suicidal ideation, depressive symptoms, number of unprotected sexual episodes; they had lower mean scores for self-esteem, and quality of life, and were more likely to have not sought medical care for HIV/AIDS. In race-specific analyses, none of the relationships between HIV discrimination and health outcomes were significant for white women. African-American women who reported HIV discrimination had higher mean scores for stress, suicidal ideation, depressive symptoms, number of unprotected sexual episodes; they had lower mean scores for self-esteem, and quality of life, and were more likely not to have sought medical care for HIV/AIDS. The findings indicated that HIV discrimination adversely affects women's mental, sexual and physical health. However, separate race-specific analyses indicated that compared to white women, African-American women were markedly more likely to experience the adverse affects of HIV discrimination. Eradication of HIV discrimination remains an important public health priority. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To compare reporting accuracy for breakfast and lunch in 2 studies. DESIGN: Children were observed eating school meals and interviewed the following morning about the previous day. In Study 1, 104 children were each interviewed 1 to 3 times with >or=25 days separating any 2 interviews. In Study 2, 121 children were each interviewed once in forward (morning-to-evening) and once in reverse (evening-to-morning) order, with these interviews separated by >or=29 days. SETTING: 12 schools. PARTICIPANTS: Fourth-grade children. MAIN OUTCOME MEASURES: For each meal, food-item variables (observed number, reported number, omission rate, intrusion rate, total inaccuracy) and kcal variables (observed, reported, correspondence rate, inflation ratio). ANALYSIS: General linear mixed models. RESULTS: For each study, observed and reported numbers of items and kcal, and correspondence rate (reporting accuracy), were greater for lunch than for breakfast; omission rate, intrusion rate, and inflation ratio (measures of reporting error) were greater for breakfast than for lunch. In Study 1, for each meal over interviews, total inaccuracy decreased and correspondence rate increased. In Study 2, for each meal for boys for reverse and for girls for forward order, omission rate was lower and correspondence rate was higher. CONCLUSIONS AND IMPLICATIONS: Breakfast was reported less accurately than lunch. Despite improvement over interviews (Study 1) and differences for order x sex (Study 2), reporting accuracy was low for breakfast and lunch. [ABSTRACT FROM AUTHOR]

Introduction: Little experimental research has evaluated whether the effects of cigarette package inserts with efficacy messages and/or pictorial health warning labels (PHWLs) differ across key subgroups of adults who smoke., Aims and Methods: Adults who reported currently smoking (n = 367) were randomly assigned to one of four groups: Small text-only HWLs on pack sides (control); inserts with efficacy messages and small HWLs (inserts-only); PHWLs showing harms of smoking (PHWLs-only); both (inserts + PHWLs). Participants received a 14-day supply of cigarettes labeled to reflect their group. Every evening over 2 weeks, participants reported forgoing and stubbing out cigarettes before they finished smoking over the prior 24 hours, combined into a binary indicator of either behavior (eg, forgoing/stubbing). Separate mixed-effects logistic models were estimated to evaluate moderation of labeling group contrasts (ie, PHWLs vs not; inserts vs. not; inserts-only vs. inserts + PHWLs; PHWLs-only vs. inserts + PHWLs) by baseline covariates (self-efficacy to quit, intention to quit, education, health literacy, and time discounting), predicting day-level forgoing/stubbing., Results: Education moderated PHWL effects, with PHWLs predicting more forgoing/stubbing only among those with low education (OR = 4.68, p < .001). Time discounting moderated insert effects, with inserts promoting forgoing/stubbing only among those with low time discounting (ie, lower impulsivity; OR = 4.35, p < .001)., Conclusions: Inserts with efficacy messages appear effective mostly among people with low time discounting, whereas PHWLs appear most effective among those with low education, suggesting their potential to address education-related disparities. Labeling strategies appeared equally effective across subgroups defined by self-efficacy to quit, quit intention, and health literacy. Combining inserts with PHWLs did not appear to mitigate moderation effects., Implications: This randomized trial with adults who smoke suggests that cigarette packs with inserts describing cessation benefits and tips can promote cessation-related behaviors (ie, forgoing or stubbing out cigarettes) among those with low-time discounting (ie, low impulsivity). Alternative interventions may be needed for people with high-time discounting, as found in cessation trials. PHWLs appear most effective among those with low education, potentially addressing education-related disparities. No differential effects were found for those with different levels of self-efficacy to quit, quit intentions, or health literacy. Combining inserts and PHWLs may not be more effective than either alone., (© The Author(s) 2024. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Background: Chronic inflammation is a key factor in type 2 diabetes mellitus (T2DM) development. The cholinergic anti-inflammatory pathway (CAP) reduces inflammation by activating α7 nicotinic acetylcholine receptors (α7nAChRs) on macrophages, suppressing proinflammatory cytokines. Acetylcholinesterase inhibitors (AChEis), primarily used for Alzheimer's disease (AD), may exert anti-inflammatory effects through the CAP. One AChEi, galantamine, also directly agonizes α7nAChRs, potentially enhancing its anti-inflammatory properties., Objective: This study aimed to investigate the association between AChEi use, particularly galantamine, and T2DM risk in AD patients., Methods: We conducted a retrospective analysis of Veterans Health Administration (VA) data, examining early- and late-onset AD patients receiving galantamine or other AD medications. Propensity score matching was used to balance groups and minimize confounding. Cox proportional hazard models assessed T2DM risk for galantamine, other AChEis and memantine., Results: A total of 40 065 AD patients were included in the study. Among early-onset AD patients, galantamine use significantly reduced T2DM risk (hazard ratio [HR] = 0.80, 95% confidence interval [CI]: 0.66-0.98). Memantine also showed a protective effect (HR = 0.82, 95% CI: 0.69-1) in this group. Neither galantamine nor memantine influenced T2DM risk in late-onset AD. Other AD medications showed no association with T2DM risk., Conclusion: Galantamine use was associated with a lower risk of T2DM in early-onset AD patients, potentially due to enhanced anti-inflammatory effects through both AChE inhibition and direct α7nAChR agonism. Memantine also demonstrated a protective effect. These findings suggest potential new applications for existing AD medications in T2DM prevention, particularly in early-onset AD patients. Further research, including randomized controlled trials with diverse populations, is needed to confirm these results and the underlying mechanisms., (© 2024 The Author(s). Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)

Limited data exist on the effects of induction treatment in patients with newly diagnosed multiple myeloma (NDMM) and renal impairment (RI), who may also be ineligible for autologous stem cell transplant. This analysis investigated the impact of lenalidomide-bortezomib-dexamethasone (RVd) induction on renal function in patients from the Connect® MM Registry based on transplant status. Eligible patients were aged ≥18 years with symptomatic MM diagnosed ≤2 months before enrollment. Patients in this analysis received front-line RVd for ≥3 cycles and were grouped by transplant status and baseline renal function. As of August 4, 2021, 344 transplanted and 289 non-transplanted patients had received RVd for ≥3 cycles at induction. Improved renal function was observed at 3, 6, and 12 months in patients with all severities of RI at baseline. In patients with >60 and ≤60 creatinine clearance mL/min at baseline, median progression-free survival was 49.4 months and 47.6 months in transplanted patients and 35.7 months and 29.1 months in non-transplanted patients, respectively. These results provide real-world evidence that patients with NDMM and RI who receive front-line RVd for ≥3 cycles may have improved renal function regardless of transplant status, with renal function no longer affecting the long-term outcome. Clinical trial information: NCT01081028., Competing Interests: Competing interests Sikander Ailawadhi reports serving on a scientific steering committee for Bristol Myers Squibb; consulting fees from BeiGene, Bristol Myers Squibb, Cellectar, GSK, Janssen, Pfizer, Regeneron, Sanofi, and Takeda; and research funding from AbbVie, Amgen, Ascentage, Bristol Myers Squibb, Cellectar, GSK, Janssen, Pharmacyclics, and Sanofi. Hans C. Lee reports serving on a scientific steering committee for Bristol Myers Squibb; consulting fees from Allogene, Bristol Myers Squibb, Genentech, GSK, Janssen, Monte Rosa Therapeutics, Pfizer, Regeneron, Sanofi, and Takeda; and grants or contracts from Amgen, Bristol Myers Squibb, GSK, Janssen, Regeneron, and Takeda. James Omel, Kathleen Toomey, James W. Hardin, Brian G.M. Durie, Mohit Narang, Howard R. Terebelo, and Rafat Abonour report serving on a scientific steering committee for Bristol Myers Squibb. Cristina J. Gasparetto reports serving on a scientific steering committee for Bristol Myers Squibb; support for travel from Bristol Myers Squibb, Karyopharm, and Sanofi; advisory role for Bristol Myers Squibb, Janssen, and Pfizer; and for Bristol Myers Squibb, Karyopharm, and Sanofi. Sundar Jagannath reports serving on a scientific steering committee for Bristol Myers Squibb; consulting fees from Bristol Myers Squibb, Janssen, Karyopharm Therapeutics, Legend Biotech, Regeneron Sanofi, and Takeda; support for travel from American Society of Clinical Oncology, American Society of Hematology (ASH), and International Myeloma Society (IMS); participation on data safety monitoring boards for Bristol Myers Squibb, Janssen, and Sanofi; and leadership or fiduciary role for ASH, IMS, and Society of Hematologic Oncology. Robert M. Rifkin reports serving on a scientific steering committee for Bristol Myers Squibb; employment, stock, and other ownership interests with McKesson; participation on data safety monitoring board for CARsgen; and advisory role with Amgen, Bristol Myers Squibb; Coherus BioSciences, Genmab, Fresenius Kabi, and Janssen. Ying-Ming Jou reports employment and stock and other ownership interests with Bristol Myers Squibb. Prashant Joshi, Jorge Mouro, and Edward Yu are former employees of Bristol Myers Squibb., (© 2024. The Author(s).)

Background: Lenalidomide (R), bortezomib (V), and dexamethasone (d) is a standard-of-care regimen in newly diagnosed multiple myeloma (NDMM); however, characteristics and outcomes for nontransplanted patients receiving frontline RVd are not well understood., Patients: The Connect Ⓡ MM Registry is a large, US, multicenter, prospective observational cohort study of NDMM patients., Methods: This analysis investigated characteristics and outcomes of patients who received RVd alone or followed by Rd or R (RVd ± Rd/R) who did not undergo frontline autologous stem cell transplantation., Results: As of August 2021, 314 of 1979 nontransplanted patients received RVd ± Rd/R as initial therapy. Of these, 135 were aged ≤ 65 years and 179 were > 65 years. 108 patients had time to relapse (TTR) of ≤ 12 months and 182 had TTR > 12 months. Baseline characteristics were comparable regardless of TTR and age group except renal function, which was more commonly impaired in older patients. Among patients aged ≤ 65 and > 65 years, median duration of first-line treatment was 6.3 and 9.0 months, median time to next line for those who received second-line therapy was 15.5 and 15.2 months, median progression-free survival (PFS) was 19.3 and 23.0 months, and median overall survival was 60.0 and 59.1 months, respectively. High-risk disease (per IMWG criteria) and high serum calcium were associated with higher hazard of progression or death; the adjusted PFS hazard ratio with respect to age (≤ 65 vs. > 65 years) based on multivariable analysis was 1.18 (0.89-1.57; P = .25)., Conclusion: These results indicate RVd is active across age groups and provide a better understanding of outcomes with RVd in NDMM., (Copyright © 2024. Published by Elsevier Inc.)

Introduction: This study assessed quit attempts among adults who use cigarettes either exclusively or with e-cigarettes in Mexico, where non-daily smoking predominates., Methods: An open cohort of Mexican adults who smoke was surveyed every four months from November 2018 to March 2021. Participants followed to the next survey were analyzed (n = 2220 individuals, 4560 observations). Multinomial logistic models regressed smoking quit attempts reported at the followup survey (ref = no attempt; tried to quit; sustained attempt of ≥30 days) on e-cigarette use frequency (none = ref; 1-2 days/week; ≥3 days/week), adjusting for sociodemographics and smoking-related variables. Additional models subdivided e-cigarette users by intentions to quit smoking in the next six months (i.e., yes/no), use of nicotine (i.e., yes/no), and vaping device used (i.e., open/closed)., Results: At 4-month follow-up, 32.7 % had tried to quit, and 2.9 % had quit for 30 days or more. Compared to those who smoke exclusively, occasional, and frequent e-cigarette users were more likely to try to quit (Adjusted Relative Risk Ratio or ARRR = 1.26 and 1.66, respectively) but no more likely to sustain their quit attempt. Among those who intended to quit smoking, e-cigarette users were no more likely to either try or sustain quit attempts. Furthermore, use of e-cigarettes with nicotine (59.6 %) was unassociated with cessation except that those who frequently used e-cigarettes with nicotine were more likely to try to quit than those who smoke exclusively (ARRR = 1.88). Device type used was not differentially associated with outcomes., Conclusions: Mexicans who smoke and use e-cigarettes appear more likely than those who smoke exclusively to try to quit but not to sustain abstinence., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier Ltd.)

Background: By inhibiting xanthine oxidase, subsequent inflammatory cytokine release and the resulting breakdown of the blood-retina barrier, allopurinol may limit the inflammation-driving diabetic macular edema (DME)., Methods: We examined the relationship between allopurinol and DME among type 2 diabetic United States veterans using a retrospective cohort study.  We used propensity score matching and Cox hazard models to estimate the risk of DME., Results: Propensity score-matched Cox models revealed allopurinol was associated with a 24.6% reduction in the risk of DME (HR = 0.754; 95% CI = (0.684-0.831))., Conclusion: Allopurinol could reduce the risk of DME, one of the major causes of visual disturbance among diabetic patients. Further research into the effects of allopurinol on DME is warranted.

Cisplatin use is often limited by its ototoxic side effects, which can lead to irreversible hearing loss. Preventing cisplatin-induced ototoxicity is crucial to improve patient outcomes. Fluoxetine and fluvoxamine, both selective serotonin reuptake inhibitors antidepressants, inhibit the NLR pyrin domain-containing protein 3 inflammasome, a potential therapeutic target for preventing ototoxicity. However, human studies have not evaluated if these antidepressants may protect against cisplatin-induced ototoxicity. The object of this study is to assess the association between fluoxetine or fluvoxamine use and incidence of hearing loss or tinnitus in a large cohort of patients receiving cisplatin chemotherapy. We use a retrospective cohort study within the U.S. Department of Veterans Affairs healthcare system. Adult patients with cancer who received cisplatin chemotherapy between 2000 and 2023 are included. Incidence of ototoxicity, defined by international classification of diseases revision 9-CM or international classification of diseases revision 10-CM diagnoses of hearing loss or tinnitus is compared between concurrent use of fluoxetine or fluvoxamine and cisplatin alone. A total of 20,552 patients were included. Of those, 489 received cisplatin and fluoxetine or fluvoxamine. After propensity score adjustment, the hazard of ototoxicity was lower in the group receiving fluoxetine or fluvoxamine compared to the group receiving cisplatin alone (HR = 0.62, 95% CI = (0.41-0.94)). Fluoxetine or fluvoxamine use may be associated with a reduced risk of cisplatin-induced ototoxicity. Randomized clinical trials are needed to confirm these findings and establish the efficacy of the medications in ototoxicity prevention. Further research is also warranted to investigate the potential mechanisms underlying this protective effect., Competing Interests: Declaration of conflicting interestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Sutton has received research grants from Boehringer-Ingelheim, Gilead Sciences, Alexion Pharmaceuticals, and United Therapeutics, all for projects unrelated to study. J.A. is a co-founder of DiceRx, iVeena Holdings, iVeena Delivery Systems and Inflammasome Therapeutics, and, unrelated to this work, he has been a board member for Theragen and consultant for Abbvie/Allergan, Boehringer-Ingelheim, Janssen, Olix Pharmaceuticals, Retinal Solutions, and Saksin LifeSciences. The other authors declare no competing interests.

Background: Physical activity is associated with lower risk of dementia and cognitive impairment, but existing randomized controlled trials have shown conflicting results. As cognitive decline occurs decades before the onset of dementia, physical activity interventions initiated in late life may have missed the potential window for prevention. An ideal trial of physical activity initiated from midlife and lasts till incident dementia and cognitive impairment in late life is not feasible. We aimed to estimate the effectiveness of a hypothetical physical activity intervention initiated from midlife on reducing dementia and cognitive impairment by emulating target trials using observational data., Methods: The Health and Retirement Study was used to emulate target trials among noninstitutionalized participants aged 45 to 65 years with normal cognition who were physically inactive in the previous 2 years. Cognitive status was determined based on Langa-Weir classification of cognitive function (including immediate and delayed word recall tests, serial sevens subtraction, counting backward). Individuals were categorized as initiating physical activity or not, based on the self-reported physical activity. Intention-to-treat and per-protocol analysis were conducted with pooled logistic regression models with inverse-probability of treatment and censoring weights to estimate risk ratios (RRs), and 95% confidence intervals (95% CIs) were calculated with 200 sets of bootstrapping., Results: Among 1505 participants (average age 57.6 ± 4.8 years, 67% women, 76.5% White), 72 cases of dementia and 409 cases of cognitive impairment occurred. After 12 years of follow-up, physical activity reduced dementia (RR = 0.70, 95% CI: 0.43, 0.99) for intention-to-treat analysis, and reduced dementia (RR = 0.51, 95% CI: 0.19, 0.99) and cognitive impairment (RR = 0.77, 95% CI: 0.61, 0.92) for per-protocol analysis. No significant reduction was found among older adults., Conclusions: Physical activity initiated during midlife may reduce dementia and cognitive impairment in late life, which highlights the importance of preventing cognitive outcomes at an earlier stage of life., (© 2024 The American Geriatrics Society.)

Background and Objectives: Non-Hispanic Black populations (NHB) have a significantly higher prevalence of dementia than non-Hispanic Whites in the U.S., and the underlying risk factors may play a role in this racial disparity. We aimed to calculate risk scores for dementia among non-Hispanic White (NHW) and non-Hispanic Black populations aged 50-64 years over a period of 10 years, and to estimate potential differences of scores between NHW and NHB., Research Design and Methods: The Health and Retirement Study from 2006 to 2016 was used to calculate the Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) risk score, a validated score for predicting dementia risk. Weighted average CAIDE score, as well as CAIDE score for modifiable factors hypertension, obese, hypercholesterolemia, physical inactivity), and non-modifiable factors (age, sex, education) were calculated for adults aged 50-64 years with normal cognition for 2006-2008, 2010-2012, 2014-2016. The associations of race with CAIDE score and elevated CAIDE score were examined., Results: A total of 10,871 participants were included in the analysis. The CAIDE score showed declining trends for NHB from 2006 to 2016, while NHB consistently had a higher total CAIDE score and CAIDE score for modifiable factors from 2006 to 2016, but not for non-modifiable factors., Discussion and Implications: NHB had a higher level of dementia risk factors than NHW among adults aged 50-64 years in the U.S. from 2006 to 2016, and the difference is attributable to modifiable risk factors, which holds promise for risk reduction of dementia., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Motivated by improving the prediction of the human immunodeficiency virus (HIV) suppression status using electronic health records (EHR) data, we propose a functional multivariable logistic regression model, which accounts for the longitudinal binary process and continuous process simultaneously. Specifically, the longitudinal measurements for either binary or continuous variables are modeled by functional principal components analysis, and their corresponding functional principal component scores are used to build a logistic regression model for prediction. The longitudinal binary data are linked to underlying Gaussian processes. The estimation is done using penalized spline for the longitudinal continuous and binary data. Group-lasso is used to select longitudinal processes, and the multivariate functional principal components analysis is proposed to revise functional principal component scores with the correlation. The method is evaluated via comprehensive simulation studies and then applied to predict viral suppression using EHR data for people living with HIV in South Carolina., (© 2024 The Author(s). Biometrical Journal published by Wiley‐VCH GmbH.)

Introduction: Cigarette package inserts that describe quitting benefits and tips may promote cessation; however, research is needed to understand better their effects, including potentially enhancing the effects of pictorial health warning labels (PHWLs)., Methods: A randomized trial with a 2×2 factorial design was conducted with adult smokers (n=356) assigned to either small text-only health warning labels (HWLs; control); inserts with cessation messages, and the small text-only HWLs (inserts-only); large PHWLs (PHWLs-only); both inserts and PHWLs (inserts + PHWLs). Participants received a 14-day supply of their preferred cigarettes with packs labeled to reflect their group. Upon finishing the trial, participants reported their past 14-day frequency of noticing, reading, thinking about smoking harms and cessation benefits, talking about labels, and forgoing cigarettes because of the labels. Ordered logistic models regressed these outcomes on labeling groups, and mediation analyses assessed whether attention (i.e. noticing, reading) to labels mediated effects of labeling exposure on other outcomes (i.e. thinking about harms/benefits, talking, forgoing)., Results: The inserts + PHWLs group reported higher frequencies than the control group for all outcomes. Compared to the control group, both the inserts-only and PHWLs-only groups reported higher frequency of noticing (AOR=3.53 and 2.46, respectively) and reading labels (AOR=2.89 and 1.71), thinking about smoking risks because of the labels (AOR=1.93 and 1.82), and talking about labels (AOR=2.30 and 2.70). Participants in the inserts-only group also reported more frequent thinking about quitting benefits (AOR=1.98). Attention mediated all labeling effects except for the contrast between PHWLs only and control., Conclusions: Compared to text-only HWLS, cigarette labeling that involves inserts, PHWLs, or both appears more effective at drawing attention to warnings, which mediated the effects on cessation-related psychosocial and behavioral outcomes., Competing Interests: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. The authors declare that they have no competing interests, financial or otherwise, related to the current work. All the authors report that since the initial planning of the work, this study was supported by the National Cancer Institute of the National Institutes of Health. J.W. Hardin reports that in the past 36 months participated on scientific review board of Celgene (Bristol Myers Squibb), which is unrelated to this manuscript. E.E. Hackworth reports that in the past 36 months received support for attending meetings and travelling from the National Institute on Drug Abuse, Society for the Study of Addiction, University of South Carolina. J.F. Thrasher reports that in the past 36 months there were grants or contracts from the UK Medical Research Council, the University of South Carolina, the Food & Drug Administration/NIH, the Canadian Institutes of Health Research, the Australian National Health and Medical Research Council and the American Cancer Society. In the past 36 months, he has also received consulting fees from the University of Stirling and has received payments for lectures/ presentations from the University of Alabama. He has also participated on the University of South Carolina Board for NIH for a funded clinical trial. Finally, J.F. Thrasher reports that in the past 36 months participated in the “Smokefree South Carolina” and the Tobacco Product Scientific Advisory Committee of the US Food and Drug Administration. J. Niederdeppe reports that in the past 36 months there were grants or contracts from the Agency for Research on Healthcare Quality (Grant to Cornell), Robert Wood Johnson Foundation (Multiple Grants to Cornell), National Institute of Diabetes and Digestive and Kidney Diseases (Grant to Cornell) and the National Science Foundation (Grant to Cornell). In the past 36 months, he has also received Payment for service on academic panel during Policy Dissemination Science workshop from New York University, Honorarium for public lecture and keynote speech + travel reimbursement from Peking University, a small payment (which is standard) for service on several grant review panels from NIH Office of the Director. He also reports that he has travelled for several workshops and consensus committee report meetings paid for by the National Academies (no honoraria or consulting fee is part of this work) from the National Academy of Medicine, and has travelled to Monterrey for a 2-day meeting to inform public health investments for the Hayward Institute (received small honorarium as well) from the Hayward Institute. In the past 36 months, he has offered service on center grant EAB, including consulting payment and travel to one meeting/year from the University of North Carolina, and has offered service on center grant EAB, including consulting payment and travel to one meeting/year from the University of Wake Forest. Finally, J. Niederdeppe reports that in the past 36 months he had an unpaid role on BOD for local non-profit that provides mental health and wellness services from Family & Childrens Service of Ithaca. M. Kim reports that in the past 36 months there were grants or contracts from the National Institute of Drug Abuse and the Food and Drug Administration., (© 2024 Lambert V.C. et al.)

Introduction: Heated tobacco products (HTPs) are promoted as less harmful than cigarettes; nonetheless, whether HTPs help smokers quit is uncertain., Methods: Data from 4067 Mexican adult smokers surveyed longitudinally every four months (November 2019-March 2021) were analyzed. Mixed-effects multinomial models regressed HTP use frequency (no use=reference; monthly; weekly; and daily use) on sociodemographics and tobacco/nicotine-related variables. Among participants who completed at least two surveys (n=2900) over four months, the duration of their longest smoking quit attempt (SQA) between surveys (SQAs: <30 days; ≥30 days; no SQA=reference) was regressed on HTP use frequency, and changes in the number of cigarettes smoked per day were regressed on HTP initiation between surveys, adjusting for covariates., Results: Consistent predictors of all HTP use frequencies (monthly, weekly, or daily vs no use) were daily smoking >5 cigarettes (ARRR=1.69 [95% CI: 1.12-2.55], 1.88 [95% CI: 1.26-2.81] and 6.46 [95% CI: 3.33-12.52], respectively); e-cigarette use (ARRR =5.68 [95% CI: 3.38-9.53], 6.54 [95% CI: 4.06-10.55] and 2.59 [95% CI: 1.26-5.30]); lower HTP risk perceptions (ARRR=2.12 [95% CI: 1.50-30.00], 2.25 [95% CI: 1.63-3.10] and 2.00 [95% CI: 1.25-3.22]); exposure to HTP information inside (ARRR=2.13 [95% CI: 1.44-3.15], 2.13 [95% CI: 1.49-3.05] and 3.72 [95% CI: 2.28-6.09]) and outside stores (ARRR=2.36 [95% CI: 1.56-3.57], 2.32 [95% CI: 1.65-3.25] and 2.44 [95% CI: 1.41-4.24]) where tobacco is sold; having family (ARRR=2.46 [95% CI: 1.54-3.91], 2.90 [95% CI: 1.93-4.37] and 2.96 [95% CI: 1.52-5.77]) and friends (ARRR=5.78 [95% CI: 3.60-9.30], 4.98 [95% CI: 3.22-7.72] and 6.61 [95% CI: 2.91-15.01]) who use HTPs. HTP use frequency was not associated with quit attempts, except for monthly HTP use predicting SQAs lasting ≥30 days (ARRR=2.12 [95% CI: 1.17-3.85]). Initiation of HTP use was not associated with changes in smoking frequency. Limiting analysis to those who intend to quit smoking also yielded null results., Conclusions: Among Mexican adult smokers, frequency of HTP use was mostly not associated with either cessation behaviors or changes in cigarette consumption, suggesting that HTPs have limited to no effectiveness for smoking cessation., Competing Interests: The authors have each completed and submitted an ICMJE form for disclosure of potential conflicts of interest. The authors declare that they have no competing interests, financial or otherwise, related to the current work. L. Cruz-Jiménez, I. Barrientos-Gutiérrez, D. Vidaña-Pérez, K. Gallegos-Carrillo, E. Arillo-Santillán, R. Rodríguez-Bolaños and J.W. Hardin, report that since the initial planning of the work this research was funded by the Fogarty International Center of the US National Institutes of Health under award number R01 TW010652. I. Barrientos-Gutiérrez reports that in the past 36 months received Grant MR/X004279/1 from the Medical Research Council of the UK and Grant Mexico-28-01 from The Union. J.W. Hardin reports that in the past 36 months participated on scientific review board of Bristol Myers Squibb. M. Kim reports that since the initial planning of the work, the co-author’s study of adult tobacco users’ response toward HTP marketing (2018–2021) received postdoctoral salary support, and participant incentives from FDA/NIH: Tobacco Centers of Regulatory Science 2.0, National Cancer Institute (University of California, San Francisco), and in the past 36 months for examining effects of vaping prevention messages for young people, a faculty salary support via subcontract awarded to USC (2023–) from FDA/NIH: Tobacco Centers of Regulatory Science 3.0 (University of North Carolina), and for examining social media posts related to non-cigarette tobacco products, a faculty salary support via subcontract awarded to USC (2023–) from National Cancer Institute (University of Iowa). J.F. Thrasher reports that since the initial planning of the work, the project was supported by a grant from the US NIH (the funding covered some of his salary) and that in the past 36 months there were grants or contracts from the UK Medical Research Council and was paid consulting on a UK government funded project related to his area of expertise from the University of Stirling, UK. Finally, J.F. Thrasher reports that in the past 36 months participated on a Local university DSM for a colleague’s project funded by NIH (no payments were received)., (© 2024 Cruz-Jiménez L. et al.)

Background: The utilization of total ankle arthroplasty (TAA) continues to increase. Discharge to a post-acute care (PAC) facility can increase patient morbidity and postoperative costs. The purpose of this study is to investigate the effects of age and body mass index (BMI) on discharge to a PAC facility and hospital length of stay (LOS) following TAA., Methods: A retrospective review of patients who underwent TAA from the National Surgical Quality Improvement Program (NSQIP) database was performed. Using overweight patients as the reference BMI group, sex- and age-adjusted log-binomial regression models were utilized to estimate risk ratios of BMI categories for being discharged to a PAC facility. A linear regression was utilized to estimate the effect of BMI category on hospital LOS., Results: Obese patients had 1.36 times the risk of overweight patients (P = .040), and morbidly obese patients had 2 times risk of overweight patients (P = .001) of being discharged to a PAC facility after TAA. Men had 0.48 times the risk of women (P < .001). Compared with patients aged 18 to 44 years, patients aged ≥65 years had 4.13 times the risk (P = .012) of being discharged to a PAC facility after TAA. Relative to overweight patients, on average there was no difference in hospital LOS for underweight patients, but healthy weight patients stayed an additional 0.30 days (P=.003), obese patients stayed an additional 0.18 days (P = .011), and morbidly obese patients stayed an additional 0.33 days (P = .009). Men stayed 0.29 fewer hospital days than women (P < .001) on average., Conclusion: Women and patients who are obese or morbidly obese have a longer hospital LOS and an increased chance of being discharged to a PAC facility. Increasing age is also associated with an increased risk of being discharged to a PAC. These may be important factors when developing and discussing the postoperative plan with patients prior to TAA., Levels of Evidence: Level III., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: Total ankle arthroplasty (TAA) is an effective treatment for various ankle pathologies, but some concern remains for the high associated complication and failure rates relative to major joint arthroplasty of the hip and knee. Patient body mass index (BMI) is a modifiable and potentially important preoperative variable when evaluating postoperative complications. The purpose of this study is to evaluate the effect of BMI, age and sex on the acute postoperative complication rate after TAA., Methods: We retrospectively reviewed adult patients who underwent TAA between 2006 and 2021 from the NSQIP database. Using overweight patients as the reference BMI group, we utilized log-binomial models to estimate risk ratios on outcomes while adjusting for sex and age to investigate whether there were significant adjusted differences in complication rates among the BMI groups., Results: We found that, relative to overweight patients, there were no statistically significant differences in the risk of acute complications for underweight (BMI < 18.5) (P = .118), healthy weight (18.5≤BMI < 25) (P = .544), obese (30≤BMI < 40) (P = .930), or morbidly obese (BMI < 40) (P = .602) patients who underwent TAA. There were also no statistically significant differences in the risk of acute complications based on age category (P = .482,.824) or sex (P = .440) for TAA. Additionally, there were no significant differences between the BMI groups for either major complications (P = .980) or minor complications (P = .168)., Conclusion: Ultimately, we found that BMI, age, and sex did not lead to statistically significant differences in the risk of complications within 30 days postoperatively for TAA, even when stratified by major vs minor complications., Level of Evidence: Level III., Competing Interests: Declaration of Competing Interest There was no conflicts of interest for any of the authors. No funding was received for this study. AI was not used for this article., (Copyright © 2023 European Foot and Ankle Society. Published by Elsevier Ltd. All rights reserved.)

Background: The birthrate of Black preterm (BPT) infants is 65% higher than White preterm (WPT) infants with a BPT mortality that is 2.3 times higher. The incidence of culture-positive late-onset sepsis is as high as 41% in very-preterm infants. The main purpose of this study was to examine thermal gradients and the heart rate in relation to the onset of infection. This report presents disparities in very-preterm infection incidence, bacteria, and mortality data amongst BPT and WPT infants., Methods: 367 preterms born at <32 weeks gestational age (GA) between 2019-2023 in five neonatal intensive care units (NICUs) were enrolled to study the onset of infections and dispositions; REDCap data were analyzed for descriptive statistics., Results: The 362 infants for analyses included 227 BPTs (63.7%) and 107 WPTs (29.6%), with 28 infants of other races/ethnicities (Hispanic, Asian, and other), 50.6% female, mean GA of 27.66 weeks, and 985.24 g birthweight. BPT infants averaged 968.56 g at birth (SD 257.50), and 27.68 (SD 2.07) weeks GA, compared to WPT infants with a mean birthweight of 1006.25 g (SD 257.77, p = 0.2313) and 27.67 (SD 2.00, p = 0.982) weeks GA. Of the 426 episodes of suspected infections evaluated across all the enrolled infants, the incidence of early-onset sepsis (EOS) was 1.9%, with BPT infants having 2.50 times higher odds of EOS than WPT infants ( p = 0.4130, OR (odds ratio) = 2.50, p &#95;or = 0.408). The overall incidence of late-onset sepsis (LOS) was 10.8%, with LOS in 11.9% of BPT infants versus 9.3% ( p = 0.489, OR = 1.21, p &#95;or = 0.637) of WPT infants. BPT infants made up 69.2% of the 39 infants with Gram-positive infections vs. 25.6% for WPT infants; 16 infants had Gram-negative culture-positive infections, with 81.2% being BPT infants versus 18.8% being WPT infants. Of the 27 urinary tract infections, 78% were in BPTs. The necrotizing enterocolitis incidence was 6.9%; the incidence in BPT infants was 7.5% vs. 6.5% in WPT infants. The overall mortality was 8.3%, with BPTs at 8.4% vs. WPT infants at 9.3%, ( p = 0.6715)., Conclusions: BPTs had a higher rate of positive cultures, double the Gram-negative infections, a much higher rate of urinary tract infections, and a higher rate of mortality than their WPT counterparts. This study emphasizes the higher risk of morbidity and mortality for BPTs.

This study combines data from five studies in a quantitative modeling approach to improve identification of tics and tic disorders using two questionnaires (the Motor or Vocal Inventory of Tics and the Description of Tic Symptoms), administered to parents and children N = 1 , 307 . Combining final diagnoses (positive or negative for tic disorder) with data from recently developed questionnaires implemented to assist in the identification of tics and tic disorders in children, we investigate methods for predicting positive diagnosis while also identifying which items in the questionnaires are most predictive. Logistic regression and random forest models are compared using various summary statistics. We further discuss the differences in errors (false positives versus false negatives) in the specification of predictive model tuning parameters. Compared to logistic regression models, random forest models provided comparable and often superior predictive abilities and were also more useful in summarizing the contributions to predictions from individual questions. The combined analyses identified a subset of screener questions that were the best predictors of tic disorders; the identified questions differed based on parent or self-report. These results provide information to inform the future development of tools to screen for tics in a variety of healthcare and epidemiological settings., Competing Interests: Disclosure statement No potential conflict of interest was reported by the author(s).

Purpose: Radiation therapy (RT) is an important treatment modality for patients with multiple myeloma (MM). Although patients are living longer with MM, they are more likely to have comorbidities related to treatment, such as bone pain; however, RT can provide symptom relief. To date, the characterization of patients who have received RT in the real-world setting has been limited., Methods and Materials: The Connect® MM Registry is a large, US multicenter, prospective observational cohort study of adult patients with newly diagnosed MM from mostly community sites. RT utilization and outcomes were analyzed quarterly throughout treatment. Factors associated with RT use were identified via multivariable analysis., Results: A total of 3011 patients were enrolled in the Connect MM Registry with 903 patients (30%) having received RT at any time. There was a significant difference (P < .05) in overall RT use among patients with an Eastern Cooperative Oncology Group performance status of 0 to 1 versus ≥2, International Staging System disease stage I/II versus III, a history of plasmacytoma or a novel agent in their first regimen, and any number of bone lesions or severe osteoporosis/fracture. RT use was associated with having bone lesions or severe osteoporosis (vs not having bone lesions). Additionally, RT use was associated with ethnicity (Hispanic vs not) and Connect MM Registry cohort (cohort 1 [enrolled 2009-2011] vs 2 [enrolled 2012-2016]). In the 6 months before death, increased RT use was associated with increasing number of treatment lines (P < .0001) and high- versus standard-risk disease (per International Myeloma Working Group criteria; P = .0028)., Conclusions: Real-world results from the Connect MM Registry show RT is frequently used and is associated with clinical factors, including performance status and disease stage. Earlier in MM diagnosis, RT may be used as an adjunct to palliate symptoms or delay systemic therapy. Toward the end of life, RT is more frequently used for palliation when treatment options are often limited., Competing Interests: Disclosures Dr Ballas reports travel fees associated with a leadership role with the American Board of Radiology and fees for providing expert legal testimony. Dr Ailawadhi reports consulting fees from GSK, Sanofi, Bristol Myers Squibb (BMS), Takeda, BeiGene, Janssen, Regeneron, Cellectar, and Pfizer; serving on a scientific steering committee for BMS; and research funding for his institution from GSK, BMS, Pharmacyclics, Amgen, Janssen, Cellectar, AbbVie, Ascentage, and Sanofi. Dr Gasparetto reports payments or honoraria, and travel fees from Sanofi, Karyopharm, and BMS; serving on a scientific steering committee for BMS; and serving on advisory boards for Pfizer, Janssen, and BMS. Dr Lee reports grants or contracts from Amgen, BMS, Janssen, GSK, Regeneron, and Takeda; consulting fees from BMS, Celgene, Genentech, Janssen, Regeneron, GSK, Sanofi, Pfizer, Monte Rosa Therapeutics, Takeda, and Allogene Therapeutics; and serving on a scientific steering committee for BMS. Dr Rifkin is a current employee of McKesson and reports serving on data safety monitoring boards for CARsgen; advisory boards for Amgen, BMS, Coherus, Fresenius Kabi, Genmab, and Janssen; and a scientific steering committee for BMS. Dr Jagannath reports consultancy fees from BMS, Janssen, Legend Biotech, Regeneron, Takeda, Sanofi, and Karyopharm; serving on steering committees and data safety monitoring or advisory boards for Janssen, BMS, and Sanofi; support for attending IMS, ASH, and ASCO; and leadership or fiduciary roles with IMS, SOHO, and ASH. Dr Narang, James W. Hardin, Brian G. M. Durie, Kathleen Toomey, James Omel, Lynne Wagner, Rafat Abonour, Howard R. Terebelo report serving on a scientific steering committee for BMS. Dr Joshi, Edward Yu, and Liang Liu are employees of BMS., (Copyright © 2023 American Society for Radiation Oncology. Published by Elsevier Inc. All rights reserved.)

Importance: Age-related macular degeneration (AMD) is a serious and common ophthalmologic disorder that is hypothesized to result, in part, from inflammatory reactions in the macula. Alzheimer disease (AD) treatment, acetylcholinesterase inhibitors (AChEIs), have anti-inflammatory effects and it remains unclear if they modify the risk of AMD., Objective: To investigate the association between AChEI medications and the incidence of AMD., Design, Setting, and Participants: This propensity score-matched retrospective cohort study took place at health care facilities within the US Department of Veterans Affairs (VA) health care system from January 2000 through September 2023. Participants included patients diagnosed with AD between ages 55 and 80 years with no preexisting diagnosis of AMD in the VA database., Exposure: AChEIs prescription dispensed as pharmacologic treatments for AD., Main Outcomes and Measure: The first diagnosis of AMD., Results: A total of 21 823 veterans with AD (mean [SD] age, 72.3 [6.1] years; 21 313 male participants [97.7%] and 510 female participants [2.3%]) were included. Propensity score-matched Cox model reveals each additional year of AChEI treatment was associated with a 6% lower hazard of AMD (hazard ratio, 0.94; 95% CI, (0.89-0.99)., Conclusions and Relevance: This observational study reports a small reduction in the risk of AMD among veterans with AD receiving AChEIs. Randomized clinical trials would be needed to determine if there is a cause-and-effect relationship and further research is required to validate these findings across diverse populations.

Background: Both isolated talonavicular arthrodesis and talonavicular and subtalar (such as double) arthrodesis can be effective treatments for adult-acquired flatfoot deformity (AAFD) with good success rates, but double arthrodesis has become more commonly performed in recent years. The purpose of this study is to evaluate whether isolated talonavicular versus talonavicular and subtalar arthrodesis led to significantly different 30-day postoperative complication rates in patients with AAFD., Methods: We performed a retrospective review to identify a large cohort of adult patients with the diagnosis of AAFD or posterior tibial tendon deformity (PTTD) who underwent isolated talonavicular or talonavicular and subtalar arthrodesis between 2006 and 2020 from the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP). To investigate whether there was a difference in complication rate between the 2 surgical cohorts, we estimated logistic regression models and log-binomial models on each of the outcomes while also adjusting for sex and age., Results: We found that there was no significant difference in the rate of major complications (P = .567) or readmissions (P = .567) between patients who underwent isolated talonavicular versus talonavicular and subtalar arthrodesis for AAFD. However, there was a significantly higher rate of minor complications in patients who underwent isolated talonavicular arthrodesis when compared with patients who underwent talonavicular and subtalar arthrodesis (P = .009)., Conclusion: This study found that there was no increased risk of 30-day postoperative complications or readmissions with talonavicular and subtalar arthrodesis when compared with isolated talonavicular arthrodesis for AAFD. In addition, there was no increased risk of major complications for talonavicular and subtalar arthrodesis when compared with isolated talonavicular arthrodesis, and isolated talonavicular arthrodesis actually carried a higher risk of minor complications for this surgical cohort. This may provide valuable information for surgeons considering surgical treatment for a particular case of AAFD., Level of Evidence: Level III., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Objective: This study aimed to investigate the associations between total serum bilirubin levels and the incidence of venous thromboembolism (VTE) among patients with influenza infection., Methods: A retrospective cohort study was conducted among outpatients with laboratory-confirmed influenza using data from the Veterans Affairs Informatics and Computing Infrastructure (VINCI). Propensity score weighting was applied to balance study groups across baseline covariates. Cox proportional hazards models assessed VTE risk by total bilirubin levels, adjusting for important covariates including age, sex, race, comorbidity index, BMI, and smoking status., Results: A total of 487 patients with total bilirubin levels <0.3 mg/dL, 8608 patients with levels between 0.3-1 mg/dL, and 1148 patients with levels >1 mg/dL were included. Patients with bilirubin <0.3 mg/dL exhibited a 6-fold higher risk of VTE compared to those with levels 0.3-1 mg/dL within 30 days of infection (HR = 6.2, 95% CI = 1.46-26.42). Elevated risks were noted through 90 days post infection (HR = 4.71, 95% CI = (1.42-15.67))., Conclusions: Serum bilirubin levels, particularly below 0.3 mg/dL, were significantly associated with an increased risk of VTE among individuals with influenza. These findings suggest that lower bilirubin levels may contribute to heightened inflammatory responses and subsequent thromboembolic events in patients with influenza. The underlying mechanisms and potential therapeutic implications for VTE prevention among patients with acute respiratory infection warrants further consideration., Competing Interests: Data AvailabilityAnalyses of the Veterans Health Administration Database were performed using data within the US Department of Veterans Affairs secure research environment, the VA Informatics and Computing Infrastructure (VINCI). The completeness, utility, accuracy, validity, and access methods are described on the VA website, https://www.virec.research.va.gov. Declaration of Conflicting InterestsThe authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: Cigarette pack inserts with messages on cessation benefits and advice are a promising labeling policy that may help promote smoking cessation., Purpose: To assess insert effects, with and without accompanying pictorial health warning labels(HWLs), on hypothesized psychosocial and behavioral outcomes., Methods: We conducted a 2 × 2 between-subject randomized trial (inserts with efficacy messages vs. no inserts; large pictorial HWLs vs. small text HWLs), with 367 adults who smoked at least 10 cigarettes a day. Participants received a 14-day supply of their preferred cigarettes with packs modified to reflect their experimental condition. Over 2 weeks, we surveyed participants approximately 4-5 times a day during their smoking sessions, querying feelings about smoking, level of worry about harms from smoking, self-efficacy to cut down on cigarettes, self-efficacy to quit, hopefulness about quitting, and motivation to quit. Each evening, participants reported their perceived susceptibility to smoking harms and, for the last 24 hr, their frequency of thinking about smoking harms and cessation benefits, conversations about smoking cessation or harms, and foregoing or stubbing out cigarettes before they finished smoking. Mixed-effects ordinal and logistic models were estimated to evaluate differences between groups., Results: Participants whose packs included inserts were more likely than those whose packs did not include inserts to report foregoing or stubbing out of cigarettes (OR = 2.39, 95% CI = 1.36, 4.20). Otherwise, no statistically significant associations were found between labeling conditions and outcomes., Conclusions: This study provides some evidence, albeit limited, that pack inserts with efficacy messages can promote behaviors that predict smoking cessation attempts., (© Society of Behavioral Medicine 2023. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Patients with stroke/transient ischemic attack and periodontal disease (PD) are at increased risk for cardiovascular events. PD treatments that can improve stroke risk factors were tested if they might assist patients with cerebrovascular disease., Methods: In this multicenter phase II trial, patients with stroke/transient ischemic attack and moderately severe PD were randomly assigned to intensive or standard PD treatment arms. The primary outcome measure was a composite of death, myocardial infarction, and recurrent stroke, as well as adverse events. Secondary outcome included changes in stroke risk factors., Results: A total of 1209 patients with stroke/transient ischemic attack were screened, of whom 481 met the PD eligibility criteria; 280 patients were randomized to intensive arm (n=140) and standard arm (n=140). In 12-month period, primary outcome occurred in 11 (8%) in the intensive arm and 17 (12%) in the standard arm. The intensive arm was nonsuperior to the standard arm (hazard ratio, 0.65 [95% CI, 0.30-1.38]) with similar rates of adverse events (sepsis 2.1% versus 0.7%; dental bleeding 1.4% versus 0%; and infective endocarditis 0.7% versus 0%). Secondary-outcome improvements were noted in both arms with diastolic blood pressure and high-density lipoprotein cholesterol ( P <0.05)., Conclusions: In patients with recent stroke/transient ischemic attack and PD, intensive PD treatment was not superior to standard PD treatment in prevention of stroke/myocardial infarction/death. Fewer events were noted in the intensive arm and the 2 arms were comparable in the safety outcomes. Secondary-outcome measures showed a trend toward improvement, with significant changes noted in diastolic blood pressure and high-density lipoprotein in both the treatment arms., Competing Interests: Disclosures Dr Susin reports compensation from Geistlich Pharma, North America Inc. for consultant services and compensation from Nobel Biocare USA for consultant services. The other authors report no conflicts.

Oral factor Xa (FXa) inhibitors significantly reduce incidence of stroke and thromboembolic events in patients with atrial fibrillation or venous thromboembolism. Due to various factors and the lack of a randomized controlled trial comparing andexanet alfa to usual care, non-specific replacement agents including 4 F-PCC are still used off-label for FXa inhibitor bleed management. Clinical and mortality data were extracted from the inpatient medical data and Veteran Affairs (VA) vital status files over the time of March 2014 through December 2020. Propensity score-weighted models were used for this retrospective cohort study using data from the Veterans Affairs Informatics and Computing Infrastructure (VINCI). The study included 255 patients (85-andexanet alfa and 170-4 F-PCC) exposed to an oral factor Xa inhibitor and hospitalized with an acute major, gastrointestinal (GI), intracranial (ICH) or other bleed. In-hospital mortality was significantly lower in the andexanet alfa cohort compared to the 4 F-PCC cohort (10.6% vs. 25.3%, p = 0.01). Propensity score-weighted Cox models reveal a 69% lower hazard of in-hospital mortality for those treated with andexanet alfa (HR 0.31, 95% CI 0.14-0.71) compared to those treated with 4 F-PCC. Additionally, those treated with andexanet alfa had a lower 30-day mortality rate and lower 30-day hazard of mortality in the weighted Cox model (20.0% vs. 32.4%, p = 0.039; HR 0.54, 95% CI 0.30-0.98) compared to those treated with 4 F-PCC. Among 255 US veterans with major bleeding in the presence of an oral factor Xa inhibitor, treatment with andexanet alfa was associated with lower in-hospital and 30-day mortality than treatment with 4 F-PCC., (© 2023. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)

Rationale and Objective: Black men in the rural South of the United States (US) are underrepresented in weight management behavioral trials. Qualitative research is needed to inform interventions that can reduce obesity and health disparities in this population. We explored how intrapersonal, social, and environmental factors affect motivation and weight-related behaviors and how to culturally adapt behavioral interventions for Black men in the rural South., Methods: We conducted individual telephone interviews with 23 Black men (mean age 50 ± 14 years) with overweight or obesity living in rural South Carolina communities in 2020 and 2021. Interviews were audio recorded, professionally transcribed, and coded by two men's health researchers who achieved an intercoder reliability of 70%. Content analysis using QSR NVivo 12 was used to generate themes using deductive and inductive approaches., Results: Physical health and health behaviors were perceived as key determinants of overall health. Family, friends, and other social contacts often provided positive social support that increased motivation but also hindered motivation by engaging in behaviors men were trying to avoid. Younger participants had stronger views of rural environments not supporting healthy lifestyles, which compounded personal challenges such as time constraints and lack of motivation. Comfort was discussed as a critical program consideration, and gender concordance among program participants and facilitators was perceived as promoting comfort. Participants noted preferences and benefits of in-person, group programs emphasizing physical activity, and younger participants more strongly endorsed programs that incorporated sports and competition., Conclusions: Findings from this study provide important evidence to inform the development of weight management interventions for Black men in the rural US South. Based on these findings, an innovative, competitive "football-themed" weight management program promoting peer support and integrating competitive physical activities is being evaluated for younger Black men in the rural South., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Background: The Together Everyone Achieves More Physical Activity (TEAM-PA) trial is a randomized controlled trial testing the efficacy of a group-based intervention for increasing physical activity (PA) among insufficiently active African American women., Design: The TEAM-PA trial uses a group cohort design, is implemented at community sites, and will involve 360 African American women. The trial compares a 10-week group-based intervention vs. a standard group-delivered PA comparison program. Measures include minutes of total PA/day using 7-day accelerometer estimates (primary outcome), and body mass index, blood pressure, waist circumference, walking speed, sedentary behavior, light physical activity, and the percentage achieving ≥150 min of moderate to vigorous PA/week (secondary outcomes) at baseline, post-intervention, and 6-months post-intervention., Intervention: The intervention integrates elements from Social Cognitive Theory, Self-Determination Theory, Group Dynamics Theory, and a focus on collectivism to evaluate different components of social affiliation (relatedness, reciprocal support, group cohesion, and collective efficacy). The intervention integrates shared goal-setting via Fitbits, group-based problem-solving, peer-to-peer positive communication, friendly competition, and cultural topics related to collectivism. Compared to the standard group-delivered PA program, participants in the intervention are expected to show greater improvements from baseline to post- and 6-month follow-up on minutes of total PA/day and secondary outcomes. Social affiliation variables (vs. individual-level factors) will be evaluated as mediators of the treatment effect., Implications: The results of the TEAM-PA trial will determine the efficacy of the intervention and identify which aspects of social affiliation are most strongly related to increased PA among African American women., Trial Registration: This study was registered on Clinicaltrials.gov (# NCT05519696) in August 2022 prior to initial participant enrollment., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships what could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier Inc. All rights reserved.)

The aim of this study was to investigate whether the use of nucleoside reverse transcriptase inhibitors (NRTIs) impacts the incidence of prediabetes or type 2 diabetes mellitus (T2DM) or the progression from prediabetes to T2DM in people living with HIV (PLWH). We conducted a retrospective cohort study using the U.S. Veterans Health Administration database among adult patients with an HIV diagnosis from the year 2000 until 2021 to determine the incidence of prediabetes and further progression to T2DM among NRTI exposed and unexposed patients. A multistate model was used to evaluate progression from normoglycemia to prediabetes and then to T2DM, and covariate adjustment with the Cox proportional hazards model was used to estimate the hazard ratios. Among 32,240 veterans diagnosed with HIV, prediabetes and T2DM were observed among 20.2% and 20.7% of patients, respectively. Among those diagnosed with prediabetes, 31.8% progressed to T2DM. Patients exposed to NRTIs at any time (86.6%), had a reduced risk of prediabetes [HR 0.50 (0.47-0.53 95% CI)] and among prediabetics, a lower risk of progression to T2DM [HR 0.73 (0.63-0.85 95% CI)] when compared to patients who never used NRTIs. In summary, NRTIs may reduce the risk of developing prediabetes and the progression from prediabetes to T2DM in PLWH., Competing Interests: J.A. has received support from the UVA Strategic Investment Fund and National Institutes of Health (NIH) grants (R01EY028027, R01EY029799, R01EY031039, R01AG082108). S.S.S., J.M., T.H.C. are supported by NIH grant R01DA054992 and the South Carolina Center for Rural and Primary Healthcare for projects unrelated to this study. J.A. is a co-founder of DiceRx, iVeena Holdings, iVeena Delivery Systems and Inflammasome Therapeutics, and, unrelated to this work, he has been a consultant for Allergan, Boehringer- Ingelheim, Janssen, Olix Pharmaceuticals, Retinal Solutions, and Saksin LifeSciences unrelated to this work. J.W.H. has received consulting fees from Celgene Corporation unrelated to this work. S.S.S has received research grants from Boehringer Ingelheim, Coherus BioSciences, Alexion Pharmaceuticals, and EMD Serono, all for projects unrelated to study. J.A., S.N., and F.P. are named as inventors on patent applications filed by the University of Virginia or the University of Kentucky.

Like cancer, Alzheimer's disease and related dementias (ADRD) comprise a global health burden that can benefit tremendously from the power of disease registry data. With an aging population, the incidence, treatment, and mortality from ADRD is increasing and changing rapidly. In the same way that current cancer registries work toward prevention and control, so do ADRD registries. ADRD registries maintain a comprehensive and accurate registry of ADRD within their state, provide disease prevalence estimates to enable better planning for social and medical services, identify differences in disease prevalence among demographic groups, help those who care for individuals with ADRD, and foster research into risk factors for ADRD. ADRD registries offer a unique opportunity to conduct high-impact, scientifically rigorous research efficiently. As research on and development of ADRD treatments continue to be a priority, such registries can be powerful tools for conducting observational studies of the disease. This perspectives piece examines how established cancer registries can inform ADRD registries' impact on public health surveillance, research, and intervention, and inform and engage policymakers., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Miller, Bayakly, Schreurs, Flicker, Adams, Ingram, Hardin, Lohman, Ford, McCollum, McCrary-Quarles, Ariyo, Levkoff and Friedman.)

Checkpoint inhibitors can be a highly effective antitumor therapy but only to a subset of patients, presumably due to immunotherapy resistance. Fluoxetine was recently revealed to inhibit the NLRP3 inflammasome, and NLRP3 inhibition could serve as a target for immunotherapy resistance. Therefore, we evaluated the overall survival (OS) in patients with cancer receiving checkpoint inhibitors combined with fluoxetine. A cohort study was conducted among patients diagnosed with lung, throat (pharynx or larynx), skin, or kidney/urinary cancer treated with checkpoint inhibitor therapy. Utilizing the Veterans Affairs Informatics and Computing Infrastructure, patients were retrospectively evaluated during the period from October 2015 to June 2021. The primary outcome was overall survival (OS). Patients were followed until death or the end of the study period. There were 2316 patients evaluated, including 34 patients who were exposed to checkpoint inhibitors and fluoxetine. Propensity score weighted Cox proportional hazards demonstrated a better OS in fluoxetine-exposed patients than unexposed (HR: 0.59, 95% CI 0.371-0.936). This cohort study among cancer patients treated with checkpoint inhibitor therapy showed a significant improvement in the OS when fluoxetine was used. Because of this study's potential for selection bias, randomized trials are needed to assess the efficacy of the association of fluoxetine or another anti-NLRP3 drug to checkpoint inhibitor therapy.

Objective: This study aimed to examine the association of nonsteroidal anti-inflammatory drug (NSAID) use by pregnant women during pregnancy with autism spectrum disorder (ASD) and intellectual disability (ID) in their children among Medicaid-insured mother-child dyads. Materials and Methods: We conducted a retrospective cohort study linking multiple datasets of South Carolina for the years between 2010 and 2017, in which the main exposure variable was NSAID use during pregnancy and outcome variables were ASD only, ID only, and ASD with ID. We conducted a multinomial logistic regression analysis, controlling for identified risk factors for ASD (mother's age, race, body-mass index, preeclampsia, and gestational diabetes). Results: NSAID use during pregnancy was found to be associated with ID only in both unadjusted and adjusted analyses. Children with mothers who had NSAID prescriptions were 26% more likely to have ID in comparison with children whose mothers did not have NSAID prescriptions (odds ratio: 1.26 [1.10-1.46]). The other risk factors identified for ASD were maternal age, race, preeclampsia, smoking, low birth weight, and obesity. For ID, the risk factors were maternal age, race, smoking, birth weight, overweight, and obesity, all of which were also associated with ASD with ID, except for overweight. Conclusions: NSAID usage during pregnancy was found to be associated with ID only and not with ASD. However, more research is needed to validate the effect of NSAIDs during pregnancy on ASD and ID among children.

Background: Adults with triple-class refractory (TCR) multiple myeloma (MM) have limited treatment options and poor prognosis, but the burden of TCR MM has not been well characterized. This study evaluated treatment patterns, overall survival (OS), health-related quality of life (HRQoL), and healthcare resource use (HCRU) among patients with TCR MM in US clinical practice., Patients and Methods: Patients with TCR MM in the Connect MM Registry (NCT01081028; a large, US, multicenter, prospective observational cohort study of patients with newly diagnosed MM) were included. Patient characteristics, treatment patterns, HRQoL, and HCRU were analyzed using descriptive statistics. OS was calculated using Kaplan-Meier methodology for the overall cohort and for patients with/without ≥1 post-TCR line of therapy (LOT)., Results: A total of 232 patients with TCR MM were included; 155 (67%) had ≥1 post-TCR LOT (post-TCR-Treated subgroup; median 9.9 months of follow-up). Most common post-TCR treatments were carfilzomib (47%), pomalidomide (40%), and daratumumab (26%); median treatment duration was 3.3 months. Median OS was 9.9 months in the overall population, 10.8 months in post-TCR-Treated patients, and 2.6 months for those with no new post-TCR LOT. HRQoL deteriorated and pain increased over 1 year of follow-up, with clinically meaningfully changes in EQ-5D (mean, -0.06 points) and FACT-G (mean, -9.9 points). 124 (53%) patients had ≥1 all-cause hospitalization and 58 (25%) had ≥1 MM-related hospitalization; median annualized length of stay was 35.3 and 42.9 days, respectively., Conclusion: The burden of TCR MM is substantial, emphasizing the need for more effective treatment options in the TCR setting., (Copyright © 2022 The Author(s). Published by Elsevier Inc. All rights reserved.)