Effectiveness of evidence-based fall prevention programs to reduce loneliness in the United States.

Introduction: Falls are associated with activity limitations and injuries among older adults. An estimated 25% of older adults fall each year, and over 40% of older adults report they are lonely. Small group, evidence-based fall prevention programs are widely available in the United States and may be a strategy to improve social connectedness within our aging population. The purpose of this study was to identify the effectiveness of evidence-based fall prevention programs to reduce loneliness among older adults. Administration for Community Living (ACL) grantee data were collected in a national repository. Methods: Data were analyzed from 12,944 participants across 12 fall prevention programs (e.g., A Matter of Balance, Stepping On, Tai Ji Quan, Otago Exercise Program, Bingocize) between January 2021 and July 2023. To assess loneliness, participants were asked, "how often do you feel lonely or isolated?" The response choices for this single 5-point item ranged from "never" to "always." A linear mixed-effects multivariable regression, with program type included as a random effect, was fitted to assess changes in loneliness before and after fall prevention workshops. The model controlled for program type and delivery site type as well as participants' age, sex, ethnicity, race, education, living alone, number of chronic conditions, number of falls in the three months preceding baseline, and workshop delivery site type and attendance. Results: Significant reductions in loneliness scores were observed from baseline to post-workshop (p < 0.001), which were more pronounced among participants with more frequent baseline loneliness (p < 0.001). Participants who attended more workshop sessions reported reduced loneliness at post-workshop (p = 0.028). From baseline to post-workshop, loneliness increased among participants who lived alone (p < 0.001) and reported two or more falls in the three months preceding baseline (p =0.002). From baseline to post-workshop, compared to White participants, increased loneliness was observed among Black (p = 0.040), and Asian (p < 0.001) participants. Participants with more chronic conditions reported more loneliness from baseline to post-workshop (p = 0.004). Relative to participants who attended workshops at senior centers, increased loneliness was observed among participants who attended workshops at residential facilities (p = 0.034) and educational institutions (p = 0.035). Discussion: Findings expand our understanding about the benefits of small-group fall prevention workshops to reduce loneliness among older participants. Results suggest that disease profiles, living alone, fall history, and workshop location (and attendee dynamic) may impede social connection among some participants. Beyond small group activities, purposive strategies should be embedded within fall prevention programs to foster meaningful interactions and a sense of belonging between participants. Other social connection programs, services, and resources may complement fall prevention programming to reduce loneliness.

Mapping the Landscape of Those Left Behind When a Person With Dementia Dies: Roles of Race and Ethnicity.

INTRODUCTION: People with dementia can have many family and friends who might be affected by their deaths. Pursuing the long-term aim of understanding how dementia deaths affect close family and friends, this project lays groundwork through estimates of who those close family and friends are, with special attention to race and ethnicity. METHOD: Regression models estimated associations between dementia, race/ethnicity, and close family and friend network size, controlling for age, sex, education, marital status, and household wealth for 1386 deceased people with dementia from the Health and Retirement Study (2004 to 2018). RESULTS: Persons with dementia had an average of 9.4 close family and friends at death. But patterns of close family and friends were different among non-Latino Black (10.8), Latino (9.9), and non-Latino White (9.2) people with dementia at death. Notably, non-Latino White persons with dementia had the fewest close family (3.7), followed by non-Latino Black (5.1), and Latino (7.7) persons with dementia. DISCUSSION: Knowing who might be affected by dementia deaths is the first step to explore how dementia-related deaths impact close family and friends. Future work can now sample bereaved family and friends of people with dementia to explore their experiences and develop culturally appropriate supports.

Effectiveness of a predator avoidance program for elementary-aged youth.

Introduction: With thousands of children abducted and abused each year, efforts are needed to keep children safe from predators. Revved Up Kids (RUK) is an intervention that gives elementary-aged children the necessary tools to recognize and avoid dangerous people and situations. The purposes of this study were to describe the RUK intervention components and document its effectiveness. Methods: This evaluation utilized a quasi-experimental design to determine the effectiveness of RUK. The single-session intervention was offered in two formats: one-hour (n = 119 youth) and three-hour (n = 28 youth) workshops. RUK workshop effectiveness was compared to a comparison group (n = 211 youth) that did not receive an intervention. Data were collected at baseline, immediate-post, and 1-month follow-up from second to fourth grade participants. A series of linear mixed models were fitted. Results: Compared to the comparison group, participants in both RUK workshops showed significant improvements across the three time points. More specifically, participants in the one-hour and three-hour RUK workshops significantly increased their safety knowledge measured by the Recognize Score (p < 0.01), Avoid Score (p < 0.01), and Escape Score (p < 0.01), respectively. Discussion: These effective single-session workshops can be easily introduced into schools and community-based settings to complement existing efforts to prevent child abduction and abuse.

Healthcare Disparities Among Older Adults: Exploring Social Determinants of Health and Cognition Levels.

Background: The purpose was to investigate the impact of sociodemographic factors on healthcare utilization among adults with different cognition levels (normal and impairment/dementia). Methods: We used cross-sectional data from the Health and Retirement Study (N=17,698) to assess healthcare utilization: hospital stay, nursing home stay, hospice care, and doctor visits. Results: A cohort comparison between normal and dementia/impaired cognition groups revealed significant differences. The dementia/impaired group had lower education levels, higher single/widowed status, and more racial and ethnic minorities. They experienced longer hospital and nursing home stays, varied doctor visit frequencies, and had higher mean age, greater loneliness scores, and lower family social support scores. Differences in hospitalization, nursing home, hospice care, and doctor visits were influenced by factors such as race, age, marital status, education, and rurality. Conclusion: There were disparities in healthcare utilization based on participants' characteristics and cognition levels, especially in terms of race/ethnicity, education, and rural location.

Stand-Capable Workstations Reduce Occupational Sedentary Time Among Administrative Workers.

OCCUPATIONAL APPLICATIONSIn this study, we found that workers who use stand-biased desks stood more and sat less during their workday compared to workers who use traditional desks. Stand-biased users also experienced significantly less lower back discomfort compared to both traditional and sit-stand workstation users. Based on these findings, we recommend that the use of stand-biased workstations be considered when designing or renovating work office workspaces. The health risks of sedentary behavior are inherent in most office work, but these risks can be alleviated with intentional equipment choices. Using stand-biased desks can encourage workers to move more throughout the workday without their productivity or comfort being disturbed.

Background: Sedentary activity, especially occupational sitting, is a leading cause of musculoskeletal discomfort among office workers. The amount of time employees spend seated is associated with the type of workstation that they utilize.Purpose: We investigated differences in computer utilization, physical activity, and discomfort among office workers who used three workstation types (stand-biased, sit-stand, or traditional).Methods: Among a sample of office workers (n = 61), we used data-logging software to measure computer utilization over 10 days, activity sensors to measure daily general activity levels (i.e., sitting, standing, running, etc.) during the 8am­5pm workday and the 24-h day, and the Nordic Musculoskeletal Questionnaire (NMQ) to evaluate discomfort.Results: There was no significant difference in the number of keyclicks between the three groups; however, the stand-biased group had a significantly higher word count and more errors than the traditional group. The 24-h activity data revealed that the stand-biased group had significantly more standing time, less sitting time, and fewer transitions per hour compared to their traditional counterparts.Conclusions: Stand-biased workstations can be a viable workstation alternative to reduce sitting time without decreasing activity or creating additional discomfort.

Technology Use Among Older Adults and Their Caregivers: Cross-Sectional Survey Study.

Background: Informal caregivers are called upon to provide substantial care, but more needs to be known about technology use among older adult and caregiver dyads. Objective: This study described technology use among older adults and their caregivers, explored potential correlates of technology use, and highlighted implications for practice. Methods: A cross-sectional survey was conducted among unpaid caregivers of older adults (n=486). Primary outcomes were self-reported technology (devices and functions) use among caregivers and their oldest care recipient. The concordance of technology use among caregivers and care recipients was also examined. Multivariable regression models were conducted separately for caregivers and care recipients. Results: Greater proportions of caregivers used all examined technologies, except for the medication alerts or tracking function, than care recipients. Caregivers used an average of 3.4 devices and 4.2 functions, compared to 1.8 devices and 1.6 functions used by their care recipients. Among caregivers, younger age, higher income, and higher education were associated with more technology use (P<.05). Among care recipients, younger age, not having cognitive dysfunction, and caregiver's technology use were associated with more technology use (P<.05). Conclusions: Understanding technology use patterns and device adoption across diverse caregiver and care recipient populations is increasingly important for enhancing geriatric care. Findings can guide recommendations about appropriate technology interventions and help providers communicate and share information more effectively with patients and their caregivers.

Examining Health Inequities in A1C Control over Time across Individual, Geospatial, and Geopolitical Factors among Adults with Type 2 Diabetes: Analyses of a Sample from One Commercial Insurer in a Southern State.

INTRODUCTION: Type 2 diabetes impacts millions and poor maintenance of diabetes can lead to preventable complications, which is why achieving and maintaining target A1C levels is critical. Thus, we aimed to examine inequities in A1C over time, place, and individual characteristics, given known inequities across these indicators and the need to provide continued surveillance. METHODS: Secondary de-identified data from medical claims from a single payer in Texas was merged with population health data. Generalized Estimating Equations were utilized to assess multiple years of data examining the likelihood of having non-target (>7% and ≥7%, two slightly different cut points based on different sources) and separately uncontrolled (>9%) A1C. Adults in Texas, with a Type 2 Diabetes (T2D) flag and with A1C reported in first quarter of the year using data from 2016 and 2019 were included in analyses. RESULTS: Approximately 50% had A1Cs within target ranges (<7% and ≤7%), with 50% considered having non-target (>7% and ≥7%) A1Cs; with 83% within the controlled ranges (≤9%) as compared to approximately 17% having uncontrolled (>9%) A1Cs. The likelihood of non-target A1C was higher among those individuals residing in rural (vs urban) areas (P < .0001); similar for the likelihood of reporting uncontrolled A1C, where those in rural areas were more likely to report uncontrolled A1C (P < .0001). In adjusted analysis, ACA enrollees in 2016 were approx. 5% more likely (OR = 1.049, 95% CI = 1.002-1.099) to have non-target A1C (≥7%) compared to 2019; in contrast non-ACA enrollees were approx. 4% more likely to have non-target A1C (≥7%) in 2019 compared to 2016 (OR = 1.039, 95% CI = 1.001-1.079). In adjusted analysis, ACA enrollees in 2016 were 9% more likely (OR = 1.093, 95% CI = 1.025-1.164) to have uncontrolled A1C compared to 2019; whereas there was no significant change among non-ACA enrollees. CONCLUSIONS: This study can inform health care interactions in diabetes care settings and help health policy makers explore strategies to reduce health inequities among patients with diabetes. Key partners should consider interventions to aid those enrolled in ACA plans, those in rural and border areas, and who may have coexisting health inequities.

Past Disparities in Advance Care Planning Across Sociodemographic Characteristics and Cognition Levels in the United States.

We aimed to examine past advance care planning (ACP) in U.S. older adults across different sociodemographic characteristics and cognition levels. We established the baseline trends from 10 years ago to assess if trends in 2024 have improved upon future data availability. We considered two legal documents in the Health and Retirement Study 2014 survey as measures for ACP: a living will and durable power of attorney for healthcare (DPOAH). Logistic regression models were fitted with outcome variables (living will, DPOAH, and both) stratified by cognition levels (dementia/impaired cognition versus normal cognition). Predictor variables included age, gender, ethnicity, race, education, marital status, rurality, everyday discrimination, social support, and loneliness. Age, ethnicity, race, education, and rurality were significant predictors of ACP (having a living will, DPOAH, and both the living will and DPOAH) across cognition levels. Participants who were younger, Hispanic, Black, had lower levels of education, or resided in rural areas were less likely to complete ACP. Examining ACP and its linkages to specific social determinants is essential to understanding disparities and educational strategies needed to facilitate ACP uptake among different population groups. Accordingly, this study aimed to examine past ACP disparities in relation to specific social determinants of health and different cognition levels. Future studies are required to evaluate whether existing disparities have improved over the last 10 years when 2024 data is released. Addressing ACP disparities among diverse populations, including racial and ethnic minorities with reduced cognition levels, is crucial for enhancing health equity and access to care.

Factors Associated With Incident and Recurrent Falls Among Men Enrolled in Evidence-Based Fall Prevention Programs: An Examination of Race and Ethnicity.

We examined factors associated with incident (one) and recurrent (2+) falls among 7207 non-Hispanic White (NHW) (89.7%), non-Hispanic Black (NHB) (5.0%), and Hispanic (5.3%) men ages ≥60 years with ≥1 chronic conditions, enrolled in an evidence-based fall program. Multinomial and binary regression analyses were used to assess factors associated with incident and recurrent falls. Relative to zero falls, NHB and Hispanic men were less likely to report incident (OR = 0.55, p < .001 and OR = 0.70, p = .015, respectively) and recurrent (OR = 0.41, p < .001 and OR = 0.58, p < .001, respectively) falls. Men who reported fear of falling and restricting activities were more likely to report incident (OR = 1.16, p < .001 and OR = 1.32, p < .001, respectively) recurrent and (OR = 1.46, p < .001 and OR = 1.71, p < .001, respectively) falls. Men with more comorbidities were more likely to report recurrent falls (OR = 1.10, p < .001). Compared to those who experienced one fall, men who reported fear of falling (OR = 1.28, p < .001) and restricting activities (OR = 1.31, p < .001) were more likely to report recurrent falls. Findings highlight the importance of multi-component interventions to prevent falls.

Hypertension Medication and Medicare Beneficiaries: Prescription Drug Coverage Satisfaction and Medication Non-Adherence among Older Adults.

Hypertension is so prevalent and requires strict adherence to medications to prevent further disease or death, but there is no study examining factors related to prescription drug non-adherence among 65 years old and older. This study aims to assess the likelihood of medication nonadherence among patients based on factors such as age, race, and socioeconomic status, with the goal of identifying strategies to enhance medication adherence and mitigate associated health risks. Using the 2020 Medicare Current Beneficiary Survey Public Use File to represent nationwide Medicare beneficiaries (unweighted n = 3917, weighted n = 27,134,782), medication non-adherence was related to multiple independent variables (i.e., age, sex, race/ethnicity, socioeconomic status, comorbidities, insurance coverage, and satisfaction with insurance). Cross-tabulations and Wald chi-square tests were used to determine how much each variable was related to non-adherence. Multivariate logistic regression was used to examine the association between medication non-adherence and factors such as prescription drug coverage satisfaction and cost-reducing behavior. Specific trends in medication non-adherence emerged among beneficiaries. Non-adherence was higher in older adults aged 65- to 74-year-olds and those with more chronic conditions (OR = 2.24; 95% CI = 1.74-2.89). If patients were dissatisfied with the medications on the insurance formulary or struggled to find a pharmacy that accepted their medication coverage, they had worse adherence (OR = 2.63; 95% CI = 1.80-3.84). Formulary and coverage must be expanded to improve adherence to antihypertensive medications in Medicare beneficiaries. Older adults aged 65 to 74 years may be less adherent to their medications because they do not see the seriousness of the disease and could benefit from further counseling. Patients with limited activities of daily living and more comorbidities may struggle with complex treatment regimens and should use adherence assistance tools.

Shared Activities as a Protective Factor Against Behavioral and Psychological Symptoms of Dementia and Caregiver Stress.

Background and Objectives: Most persons with dementia experience behavioral and psychological symptoms (BPSD). While there is evidence that structured activity programs can be beneficial for persons with dementia and their caregivers, it is not well understood how joint engagement in shared activities affects BPSD and caregiver stress. The purpose of this study was to examine the moderating effect of doing a shared activity on the BPSD and caregiver stress. Research Design and Methods: This study used an intensive longitudinal observational design in which caregivers completed baseline and once-a-day diary surveys for 21 days. Caregivers were asked whether they did a pleasant noncare activity with their relative, the presence of 8 BPSD, and their stress level. A moderation model in a structural equation model examined the relationship between these variables. Results: Our sample consisted of 453 caregivers (87.4% female, 51.4% non-Hispanic White, mean age 53 years [standard deviation {SD}: 14]) and person living with dementia whose mean age was 79 years (SD: 9). On days when the caregivers engaged in a shared activity together with person living with dementia, there was a significant decrease in the BPSD (estimate -0.038, standard error [SE] = 0.016, 95% confidence interval [CI]: -0.069, -0.007, p value = 0.018). The effects of engaging in a shared activity decreased the impact of caregiver stress by 0.052 (estimate -0.052, SE = 0.018, 95% CI: -0.087, -0.017, p value = 0.004). At the between-person level, no differences were found in BPSD across caregivers who engaged or did not engage in shared activities. Discussion and Implications: The results of our study indicate that doing a shared activity is associated with reduced BPSD among persons with dementia and may buffer the impact of caregiver stress on BPSD. Shared activities should be considered a key intervention component for dementia caregivers.

Advancing Gerontology through Exceptional Scholarship (AGES): a Mentorship Initiative for Early Career Faculty.

Mentorship is critical to supporting professional development and growth of new and emerging faculty members. Working with the Gerontological Society of America (GSA), we created the Advancing Gerontology through Exceptional Scholarship (AGES) Initiative as a mentorship model to promote productivity and peer support for new and early career faculty members. In this commentary, we highlight the AGES Program as a prototype to facilitate peer support, collective learning, and co-authorship opportunities to advance new and early career faculty members, especially in the field of aging. Moreover, we identify four crucial strategies that cultivated and refined our AGES Program including: i) ensuring flexibility to address mentee needs; ii) establishing check-ins and accountability to enhance productivity; iii) fostering peer support and collective learning; and iv) delivering motivational and educational activities. Drawing on our experience with the AGES Program, this commentary provides recommendations to support other groups looking to develop high-quality mentorship programs to support new and early career faculty members in academia.

Pharmacological Prescribing and Satisfaction with Pain Treatment Among Non-Hispanic Black Men with Chronic Pain.

Introduction: Pharmacological strategies are often central to chronic pain management; however, pain treatment among non-Hispanic Black men may differ because of their disease profiles and healthcare interactions. However, less is known about pain medication prescribing and patients' satisfaction with pain treatment and management among non-Hispanic Black men with self-reported chronic pain. Purpose: This study assessed factors associated with non-Hispanic Black men being prescribed/recommended narcotics/opioids for chronic pain and their satisfaction with pain treatment/management. Methods: Data were analyzed from 286 non-Hispanic Black men with chronic pain who completed an internet-delivered questionnaire. Participants were recruited nationwide using a Qualtrics web-based panel. Logistic regression was used to identify factors associated with being prescribed/recommended narcotics/opioids for pain management treatment. Then, ordinary least squares regression was used to identify factors associated with their satisfaction level with the pain treatment/management received. Results: On average, participants were 56.2 years old and 48.3% were prescribed/recommended narcotics/opioids for chronic pain. Men with more chronic conditions (Odds Ratio [OR] = 0.57, P = 0.043) and depression/anxiety disorders (OR = 0.53, P = 0.029) were less likely to be prescribed/recommended narcotics/opioids. Men who were more educated (OR = 2.09, P = 0.044), reported more frequent chronic pain (OR = 1.28, P = 0.007), and were allowed to participate more in decisions about their pain treatment/management (OR = 1.11, P = 0.029) were more likely to be prescribed/recommended narcotics/opioids. On average, men with more frequent chronic pain (B = -0.25, P = 0.015) and pain problems (B = -0.16, P = 0.009) were less satisfied with their pain treatment/management. Men who were allowed to participate more in decisions about their pain treatment/management reported higher satisfaction with their pain treatment/management (B = 0.55, P < 0.001). Conclusion: Playing an active role in pain management can improve non-Hispanic Black men's satisfaction with pain treatment/management. This study illustrates the importance of patient-centered approaches and inclusive patient-provider interactions to improve chronic pain management.

Digital human ergonomics training for remote office workers: Comparing a novel method to a traditional online format.

OBJECTIVE: This randomized controlled trial investigated the effectiveness of an online ergonomics training program with a digital human compared to an online ergonomics training program without a digital human. METHOD: Remote office workers (n = 138) were randomly assigned to either a digital human training, a traditional webpage training without a digital human, or a control group. Musculoskeletal discomfort, knowledge retention, and behavior change were measured. RESULTS: The overall group differences for increased behavior change and knowledge retention were statistically significant (p < 0.05). For knowledge retention, the digital human training group showed comparable improvement in knowledge scores compared to the traditional training group. For behavior scores, the traditional training showed improvement compared to the control group. Decreases in musculoskeletal discomfort for all groups were not statistically significant (p > 0.05). CONCLUSION: Digital humans have the potential to meet large-scale remote worker training needs.

Contextual Factors and Adoption of Strategies Related to Opioid Prescribing Practices in Healthcare Settings: Cross-Sectional Study.

This study aimed to examine the association between different contextual factors (e.g., facility size, rurality, and perceived needs) and the adoption of a policy or strategy related to opioid prescribing practices in healthcare settings. Cross-sectional survey data was collected from a convenience sample of physicians (N = 68). Logistic regression models were used to examine the effects of contextual factors on the dependent variables. Less than half reported having a policy restricting opioid prescribing practices, and 81% reported having one or more strategies for the safe use of chronic opioid therapy. After adjusting for other contextual factors, small practice size was positively associated with having a policy restricting opioid prescribing practices. This exploratory study provides insights for further investigation of how various contextual factors can influence policy adoption in different healthcare settings and practices to address major public health threats.

Personal Agency and Social Supports to Manage Health Among Non-Hispanic Black and Hispanic Men With Diabetes.

The prevalence of type 2 diabetes (T2D) is increasing among non-Hispanic Black and Hispanic communities, especially among men who develop this chronic condition at earlier ages. Personal agency and social support are vital aspects to diabetes management. However, less is known about the relationship between these variables among men living with diabetes. The purposes of this study were to identify (1) levels of personal agency to manage health, (2) sources of social supports to manage health based on personal agency levels, and (3) factors associated with lower personal agency to manage health. Cross-sectional data from non-Hispanic Black (n = 381) and Hispanic (n = 292) men aged 40 years or older with T2D were collected using an internet-delivered questionnaire. Three binary logistic regression models were fitted to assess sociodemographics, health indicators, and support sources associated with weaker personal agency to manage health. About 68% of participants reported having the strongest personal agency relative to 32.1% reporting weaker personal agency. Men who relied more on their spouse/partner (odds ratio [OR] = 1.22, p = .025), coworkers (OR = 1.59, p = .008), or faith-based organizations (OR = 1.29, p = .029) for ongoing help/support to improve their health and manage health problems were more likely to have weaker personal agency. Conversely, men who relied more on their health care providers for ongoing help/support to improve their health and manage health problems were less likely to have weaker personal agency to manage health (OR = 0.74, p < .001). Findings suggest personal agency may influence men's support needs to manage T2D, which may also be influenced by cultural, socioeconomics, and the composition of social networks.

Group-based trajectory analysis identifies varying diabetes-related cost trajectories among type 2 diabetes patients in Texas: an empirical study using commercial insurance.

BACKGROUND: The trend of Type 2 diabetes-related costs over 4 years could be classified into different groups. Patient demographics, clinical factors (e.g., A1C, short- and long-term complications), and rurality could be associated with different trends of cost. Study objectives are to: (1) understand the trajectories of cost in different groups; (2) investigate the relationship between cost and key factors in each cost trajectory group; and (3) assess significant factors associated with different cost trajectories. METHODS: Commercial claims data in Texas from 2016 to 2019 were provided by a large commercial insurer and were analyzed using group-based trajectory analysis, longitudinal analysis of cost, and logistic regression analyses of different trends of cost. RESULTS: Five groups of distinct trends of Type 2 diabetes-related cost were identified. Close to 20% of patients had an increasing cost trend over the 4 years. High A1C values, diabetes complications, and other comorbidities were significantly associated with higher Type 2 diabetes costs and higher chances of increasing trend over time. Rurality was significantly associated with higher chances of increasing trend over time. CONCLUSIONS: Group-based trajectory analysis revealed distinct patient groups with increased cost and stable cost at low, medium, and high levels in the 4-year period. The significant associations found between the trend of cost and A1C, complications, and rurality have important policy and program implications for potentially improving health outcomes and constraining healthcare costs.

Factors associated with higher hemoglobin A1c and type 2 diabetes-related costs: Secondary data analysis of adults 18 to 64 in Texas with commercial insurance.

OBJECTIVE: This study will identify factors associated with higher hemoglobin A1c (A1c) values and diabetes-related costs among commercially insured adults in Texas diagnosed with type 2 diabetes. RESEARCH DESIGN AND METHODS: This secondary data analysis was based on claims data from commercially insured individuals 18-64 years of age residing in Texas with diagnosed type 2 diabetes during the 2018-2019 study period. The final analysis sample after all the exclusions consisted of 34,992 individuals. Measures included hemoglobin A1c, diabetes-related costs, Charlson Comorbidity Index, diabetes-related complications, rurality and other socioeconomic characteristics. Longitudinal A1c measurements were modeled using age, sex, rurality, comorbidity, and diabetes-related complications in generalized linear longitudinal regression models adjusting the observation time, which was one of the 8 quarters in 2018 and 2019. The diabetes-related costs were similarly modeled in both univariable and multivariable generalized linear longitudinal regression models adjusting the observation time by calendar quarters and covariates. RESULTS: The median A1c value was 7, and the median quarterly diabetes-related cost was $120. A positive statistically significant relationship (p = < .0001) was found between A1c levels and diabetes-related costs, although this trend slowed down as A1c levels exceeded 8.0%. Higher A1c values were associated with being male, having diabetes-related complications, and living in rural areas. Higher costs were associated with higher A1c values, older age, and higher Charlson Comorbidity Index scores. CONCLUSION: The study adds updated analyses of the interrelationships among demographic and geographic factors, clinical indicators, and health-related costs, reinforcing the role of higher A1c values and complications as diabetes-related cost drivers.

Electronic cigarette use and cigarette smoking associated with inadequate sleep duration among U.S. young adults.

OBJECTIVE: Nicotine use can influence inadequate sleep, but less is known about the associations of exclusive and dual use of electronic cigarettes (e-cigarettes) with combustible cigarettes in U.S. young adults. This study assessed the associations between current exclusive e-cigarette use, exclusive cigarette smoking, and dual e-cigarette and combustible cigarette use and inadequate sleep duration among U.S. young adults. METHODS: We performed a secondary analysis of 2020 Behavioral Risk Factor Surveillance System (BRFSS) data including 13,978 U.S. young adults ages 18-24 years. Inadequate sleep duration was assessed categorically using the National Sleep Foundation's age-specific recommendations that define <7 h as inadequate sleep. Weighted logistic regression models were performed while adjusting for participants' sex, race/ethnicity, education level, annual household income level, body mass index, current physical activity, mental health status, disability status, current alcohol use, and current smokeless tobacco use. RESULTS: Concerning use patterns, 11.8% of young adults were exclusive e-cigarette users, 4.7% were exclusive cigarette smokers, and 3.8% were dual e-cigarette and combustible cigarette users. Exclusive e-cigarette users (adjusted odds ratio [AOR] = 1.41, 95% confidence interval [CI] = 1.16-1.72), exclusive cigarette smokers (AOR = 1.63, 95%CI = 1.22-2.18), and dual product users (AOR = 2.03, 95%CI = 1.44-2.86) were at increased odds of having inadequate sleep duration compared to non-users, while adjusting for the covariates. Additionally, dual product users were at increased odds (AOR = 1.52, 95%CI = 1.06-2.19) of reporting inadequate sleep duration compared to exclusive e-cigarette users, while adjusting for the covariates. CONCLUSIONS: Current e-cigarette and cigarette use may influence inadequate sleep among U.S. young adults. Tobacco cessation efforts may encourage increased sleep health.

External control arms: COVID-19 reveals the merits of using real world evidence in real-time for clinical and public health investigations.

Randomized controlled trials are considered the 'gold standard' to reduce bias by randomizing patients to an experimental intervention, versus placebo or standard of care cohort. There are inherent challenges to enrolling a standard of care or cohorts: costs, site engagement logistics, socioeconomic variability, patient willingness, ethics of placebo interventions, cannibalizing the treatment arm population, and extending study duration. The COVID-19 pandemic has magnified aspects of constraints in trial recruitment and logistics, spurring innovative approaches to reducing trial sizes, accelerating trial accrual while preserving statistical rigor. Using data from medical records and databases allows for construction of external control arms that reduce the costs of an external control arm (ECA) randomized to standard of care. Simultaneously examining covariates of the clinical outcomes in ECAs that are being measured in the interventional arm can be particularly useful in phase 2 trials to better understand social and genetic determinants of clinical outcomes that might inform pivotal trial design. The FDA and EMA have promulgated a number of publicly available guidance documents and qualification reports that inform the use of this regulatory science tool to streamline clinical development, of phase 4 surveillance, and policy aspects of clinical outcomes research. Availability and quality of real-world data (RWD) are a prevalent impediment to the use of ECAs given such data is not collected with the rigor and deliberateness that characterizes prospective interventional control arm data. Conversely, in the case of contemporary control arms, a clinical trial outcome can be compared to a contemporary standard of care in cases where the standard of care is evolving at a fast pace, such as the use of checkpoint inhibitors in cancer care. Innovative statistical methods are an essential aspect of an ECA strategy and regulatory paths for these innovative approaches have been navigated, qualified, and in some cases published.