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Background: Among patients with cirrhosis, it remains unclear whether there are racial/ethnic differences in cirrhosis complications and mortality. We examined the associations between race/ethnicity and risk for hepatocellular carcinoma (HCC), cirrhosis decompensation, and all-cause mortality overall and by cirrhosis etiology. Methods: US Veterans diagnosed with cirrhosis from 2001 to 2014 (n = 120,992), due to hepatitis C virus (HCV; n = 55,814), alcohol-associated liver disease (ALD; n = 36,323), hepatitis B virus (HBV; n = 1,972), nonalcoholic fatty liver disease (NAFLD; n = 17,789), or other (n = 9,094), were followed through 2020 for incident HCC (n = 10,242), cirrhosis decompensation (n = 27,887), and mortality (n = 81,441). Multivariable Cox proportional hazards regression was used to estimate adjusted hazard ratios (aHR) and 95% confidence intervals (CI). Results: Compared with non-Hispanic White patients, Hispanic patients had higher risk for HCC overall (aHR, 1.32; 95% CI, 1.24–1.41) and by cirrhosis etiology, particularly for ALD- (aHR, 1.63; 95% CI, 1.42–1.87) and NAFLD-cirrhosis (aHR, 1.76; 95% CI, 1.41–2.20), whereas non-Hispanic Black patients had lower HCC risk in ALD- (aHR, 0.79; 95% CI, 0.63–0.98) and NAFLD-cirrhosis (aHR, 0.54; 95% CI, 0.33–0.89). Asian patients had higher HCC risk (aHR, 1.70; 95% CI, 1.29–2.23), driven by HCV- and HBV-cirrhosis. Non-Hispanic Black patients had lower risk for cirrhosis decompensation overall (aHR, 0.71; 95% CI, 0.68–0.74) and by cirrhosis etiology. There was lower risk for mortality among all other racial/ethnic groups compared with non-Hispanic White patients. Conclusions: Race/ethnicity is an important predictor for risk of developing HCC, decompensation, and mortality. Impact: Future research should examine factors underlying these racial/ethnic differences to inform prevention, screening, and treatment for patients with cirrhosis.

OBJECTIVE To assess the prevalence of household food insecurity (HFI) and Supplemental Nutrition Assistance Program (SNAP) participation among youth and young adults (YYA) with diabetes overall and by type, and sociodemographic characteristics. RESEARCH DESIGN AND METHODS The study included participants with youth-onset type 1 diabetes and type 2 diabetes from the SEARCH for Diabetes in Youth study. HFI was assessed using the 18-item U.S. Household Food Security Survey Module (HFSSM) administered from 2016 to 2019; three or more affirmations on the HFSSM were considered indicative of HFI. Participants were asked about SNAP participation. We used χ2 tests to assess whether the prevalence of HFI and SNAP participation differed by diabetes type. Multivariable logistic regression models were used to examine differences in HFI by participant characteristics. RESULTS Of 2,561 respondents (age range, 10–35 years; 79.6% ≤25 years), 2,177 had type 1 diabetes (mean age, 21.0 years; 71.8% non-Hispanic White, 11.8% non-Hispanic Black, 13.3% Hispanic, and 3.1% other) and 384 had type 2 diabetes (mean age, 24.7 years; 18.8% non-Hispanic White, 45.8% non-Hispanic Black, 23.7% Hispanic, and 18.7% other). The overall prevalence of HFI was 19.7% (95% CI 18.1, 21.2). HFI was more prevalent in type 2 diabetes than type 1 diabetes (30.7% vs. 17.7%; P < 0.01). In multivariable regression models, YYA receiving Medicaid or Medicare or without insurance, whose parents had lower levels of education, and with lower household income had greater odds of experiencing HFI. SNAP participation was 14.1% (95% CI 12.7, 15.5), with greater participation among those with type 2 diabetes compared with those with type 1 diabetes (34.8% vs. 10.7%; P < 0.001). CONCLUSIONS Almost one in three YYA with type 2 diabetes and more than one in six with type 1 diabetes reported HFI in the past year—a significantly higher prevalence than in the general U.S. population.

Purpose: Most young adult cancer survivors (YACS) do not meet physical activity (PA) guidelines. Although PA can improve health and quality of life (QOL), few randomized controlled trials (RCTs) of PA interventions for YACS exist. We conducted a pilot RCT to test feasibility of a PA intervention among YACS. Methods: We recruited 18-39-year-olds (≥1 and

Supplementary Table S5. Association between race/ethnicity and risk of cirrhosis decompensation in patients with cirrhosis overall and by cirrhosis etiology: follow-up from cirrhosis diagnosis (2001-2014) to 2020

Background:Among patients with cirrhosis, it remains unclear whether there are racial/ethnic differences in cirrhosis complications and mortality. We examined the associations between race/ethnicity and risk for hepatocellular carcinoma (HCC), cirrhosis decompensation, and all-cause mortality overall and by cirrhosis etiology.Methods:US Veterans diagnosed with cirrhosis from 2001 to 2014 (n = 120,992), due to hepatitis C virus (HCV; n = 55,814), alcohol-associated liver disease (ALD; n = 36,323), hepatitis B virus (HBV; n = 1,972), nonalcoholic fatty liver disease (NAFLD; n = 17,789), or other (n = 9,094), were followed through 2020 for incident HCC (n = 10,242), cirrhosis decompensation (n = 27,887), and mortality (n = 81,441). Multivariable Cox proportional hazards regression was used to estimate adjusted hazard ratios (aHR) and 95% confidence intervals (CI).Results:Compared with non-Hispanic White patients, Hispanic patients had higher risk for HCC overall (aHR, 1.32; 95% CI, 1.24–1.41) and by cirrhosis etiology, particularly for ALD- (aHR, 1.63; 95% CI, 1.42–1.87) and NAFLD-cirrhosis (aHR, 1.76; 95% CI, 1.41–2.20), whereas non-Hispanic Black patients had lower HCC risk in ALD- (aHR, 0.79; 95% CI, 0.63–0.98) and NAFLD-cirrhosis (aHR, 0.54; 95% CI, 0.33–0.89). Asian patients had higher HCC risk (aHR, 1.70; 95% CI, 1.29–2.23), driven by HCV- and HBV-cirrhosis. Non-Hispanic Black patients had lower risk for cirrhosis decompensation overall (aHR, 0.71; 95% CI, 0.68–0.74) and by cirrhosis etiology. There was lower risk for mortality among all other racial/ethnic groups compared with non-Hispanic White patients.Conclusions:Race/ethnicity is an important predictor for risk of developing HCC, decompensation, and mortality.Impact:Future research should examine factors underlying these racial/ethnic differences to inform prevention, screening, and treatment for patients with cirrhosis.

Background Open streets events, where roads are temporarily closed to motorized vehicles, can provide safe spaces for physical activity (PA) and become sustainable community infrastructure. Since 2016, we have collaborated with a rural community to implement an open streets event, named ciclovía. In 2019, ciclovía was adopted as a community-wide program. This paper describes the process of building and progressing a ciclovía from a research intervention to a community-adopted program and participation of a rural community in ciclovía. Methods We used community-based participatory research to foster bidirectional learning on how to optimize the content and implementation of ciclovía to be feasible and acceptable for rural communities. The community-academic partnership focused on: 1) understanding the science of ciclovía; 2) learning the implementation process; 3) creating tools to facilitate planning, implementation, and evaluation of ciclovía; and 4) developing transition steps from a research intervention to a community-adopted program. Results The progression of the research intervention to community adoption spanned 2 years. First, the partnership met quarterly to discuss the science of ciclovía, its utility, and its adaptation for rural communities. Second, the partnership studied processes that facilitated ciclovía implementation. Third, the partnership created the ciclovía planning guide and tools for communities to establish their own ciclovía. The guide included forming a planning committee, setting meeting and communication plans, marketing and promotion, and selecting evaluation tools. Fourth, the transition steps from research intervention to community adoption included creating roles and responsibilities, implementing ciclovía using the planning guide, and convening listening sessions for improvement on implementation. Community attendance at ciclovía doubled from 189 individuals (126 children and 63 adults) when it was a research intervention to 394 individuals (277 children and 117 adults) when it was a community program. Conclusions The progression from a research intervention to a community-adopted program encompasses multiple steps that involve bidirectional learning and partnership with the community. Lessons learned from this study are integrated into a disseminatable ciclovía planning guide.

Background Racial/ethnic health inequities have been well-documented among youth and young adults with type 1 diabetes (T1D), yet little is known about how socioeconomic position (SEP) intersects with the risk marker of race/ethnicity to predict inequities in longitudinal glycemic control. Purpose To identify patterns of SEP, race/ethnicity, and clinical characteristics that differentiate hemoglobin A1c (HbA1c) trajectories among youth and young adults after T1D diagnosis. Methods The SEARCH for Diabetes in Youth cohort includes youth with diabetes diagnosed from 2002 to 2006 and 2008 who were followed through 2015. We analyzed data from 1,313 youth and young adults with T1D with ≥3 HbA1c measures. Classification tree analysis identified patterns of baseline demographic, SEP, and clinical characteristic that best predicted HbA1c trajectories over an average of 8.3 years using group-based trajectory modeling. Results Two HbA1c trajectories were identified: Trajectory 1 (77%) with lower baseline HbA1c and mild increases (from mean 7.4% to 8.4%) and Trajectory 2 (23%) with higher baseline HbA1c and major increases (from 8.5% to 11.2%). Race/ethnicity intersected with different SEP characteristics among non-Hispanic white (NHW) than in non-whites. Public health insurance predicted high-risk Trajectory 2 membership in non-whites, whereas parental education, household structure, diagnosis age and glucose checking frequency predicted membership for NHW youth and young adults. Two characteristics, race/ethnicity and parental education alone identified 80% of the Trajectory 2 members. Conclusions Race/ethnicity intersects with multiple SEP and clinical characteristics among youth and young adults with T1D, which is associated with particularly high risk of poor long-term glycemic control.

OBJECTIVES: To assess the prevalence of household food insecurity (HFI) and Supplemental Nutrition Assistance Program (SNAP) participation in youth and young adults (YYA) with diabetes overall, by type, and sociodemographic characteristics. RESEARCH DESIGN AND METHODS: The study included participants with youth-onset type 1 diabetes and type 2 diabetes from the SEARCH for Diabetes in Youth study. HFI was assessed using the 18-item U.S. Household Food Security Survey Module (HFSSM) administered from 2016-2019; ³3 affirmations on the HFSSM were considered indicative of HFI. Participants were asked about SNAP participation. Chi-square tests were used to assess whether the prevalence of HFI and SNAP participation differed by diabetes type. Multivariable logistic regression models were used to examine differences in HFI by participant characteristics. RESULTS: Of 2561 respondents (age range 10-35 years; 79.6% ≤ 25 years), 2177 had type 1 diabetes (mean age 21.0 years, 71.8% non-Hispanic white, 11.8% non-Hispanic black, 13.3% Hispanic, 3.1% other) and 384 had type 2 diabetes (mean age 24.7 years, 18.8% non-Hispanic white, 45.8% non-Hispanic black, 23.7% Hispanic, 18.7% other). The overall prevalence of HFI was 19.7% (95% CI 18.1, 21.2). HFI was more prevalent in type 2 diabetes than type 1 diabetes (30.7% vs. 17.7%, p CONCLUSIONS: Almost 1 in 3 YYA with type 2 diabetes and more than 1 in 6 with type 1 diabetes reported HFI in the past year, a significantly higher prevalence than the general U.S. population.

Background: Delayed-release dimethyl fumarate (DMF) is effective in relapsing-remitting multiple sclerosis (RRMS), but long-term effects of DMF on disability and disease progression in clinical settings are unknown. We evaluated disability and employment outcomes in persons with RRMS treated with DMF for up to 5 years. Methods: This longitudinal study included US North American Research Committee on Multiple Sclerosis (NARCOMS) Registry participants with RRMS reporting DMF initiation in fall 2013 through spring 2018 with 1 year or more of follow-up. Time to 6-month confirmed disability progression (≥1-point increase in Patient-Determined Disease Steps [PDDS] score) and change in employment status were evaluated using Kaplan-Meier analysis. Participants were censored at last follow-up or at DMF discontinuation, whichever came first. Results: During the study, 725 US participants with RRMS had at least 1 year of DMF follow-up data, of whom most were female and White. At year 5, 69.9% (95% CI, 65.4%–73.9%) of these participants were free from 6-month confirmed disability progression, and 84.7% (95% CI, 78.6%–89.2%) were free from conversion to secondary progressive MS. Of 116 participants with data at baseline and year 5, most had stable or improved PDDS and Performance Scales scores over 5 years. Of 322 participants 62 years and younger and employed at the index survey, 66.0% (95% CI, 57.6%–73.1%) were free from a negative change in employment type over 5 years. Conclusions: Most US NARCOMS Registry participants treated up to 5 years with DMF remained free from 6-month confirmed disability progression and conversion to secondary progressive MS and had stable disability and employment status. These results support the long-term stability of disability and work-related outcomes with disease-modifying therapy.

Background: A walking school bus (WSB) consists of students and adults walking to and from school and promotes active commuting to school. Self-efficacy (SE) and outcome expectations (OE) are behavioral constructs associated with active commuting to school. The authors sought to assess the impact of a WSB program on child SE, and parent SE, and OE.Methods: The authors conducted a cluster randomized controlled trial of a WSB intervention from 2012 to 2016 among 22 elementary schools serving racially diverse, low-income populations in Houston, TX and Seattle, WA. Surveys collected data from third- to fifth-grade students and their parents, (n = 418) child-parent dyads, before school randomization and at the school year’s end. Child surveys included 16 SE items, while parent surveys included 15 SE items and 14 OE items. Scores were averaged from responses ranging from 1 to 3. The authors compared changes in SE and OE between groups over time and accounted for clustering using linear mixed-effects models.Results: The intervention group had increases in child SE of 0.12 points (P = .03), parent SE of 0.11 points (P = .048), and parent OE of 0.09 points (P = .02) compared to controls over time.Conclusions: As hypothesized, the WSB improved child SE, parent SE, and parent OE related to active commuting to school.

Introduction Persistence to multiple sclerosis (MS) disease-modifying therapy is fundamental for maximal treatment outcomes. Diroximel fumarate (DRF) is approved in the USA for relapsing MS. Following oral administration, DRF is metabolized to monomethyl fumarate, the active metabolite of dimethyl fumarate (DMF). DRF showed clinically significant improvements in gastrointestinal (GI) tolerability versus DMF in a head-to-head clinical trial; however, real-world persistence/adherence has not been assessed. We evaluated persistence/adherence in DRF-treated patients in a real-world clinical practice. Methods This retrospective analysis of the AcariaHealth Specialty Pharmacy Program included patients initiating DRF from 4 December 2019 through 3 April 2020 and followed until data extraction (31 August 2020). Exclusion criteria included undetermined treatment status (e.g., DRF prescription transfer to a different pharmacy). Endpoints included persistence (overall proportion of patients remaining on DRF), discontinuation rate due to GI adverse events (AEs), and adherence (proportion of days covered [PDC]). GI AEs included GI-related AEs occurring at any time, or any unknown AE without details about the nature of the event if the unknown AE occurred ≤ 90 days after DRF initiation. Results Overall, 160 patients with MS were included. Median (range) patient age was 51 (20−79) years, 80.6% (129/160) of patients were female, and 16.3% (26/160) had prior DMF treatment. Median (range) treatment duration was 7.6 (0.1−10.4) months. Estimated proportion of patients remaining persistent on DRF treatment at 8 months was 88.6% (95% confidence interval [CI] 82.5–2.7). Overall, 3.8% (6/160) of patients discontinued due to GI AEs. Mean PDC was 91.4% (95% CI 89.1−93.7). In a DMF-to-DRF switch subgroup, 92.3% (24/26) remained persistent on DRF, and 3.8% (1/26) discontinued DRF due to GI AEs. Conclusion This real-world analysis of DRF-treated patients showed high overall persistence, low discontinuation rate due to GI AEs, and high adherence to therapy, aligning with expectations based on DRF clinical trials. Data were consistent in the DMF-to-DRF subgroup. Infographic

OBJECTIVETo evaluate the relation between household food insecurity (HFI) and fear of hypoglycemia among young adults with type 1 and type 2 diabetes and adolescents with type 1 diabetes and their parents.RESEARCH DESIGN AND METHODSWe analyzed cross-sectional data of 1,676 young adults with youth-onset diabetes (84% type 1, 16% type 2) and 568 adolescents (RESULTSAdults with type 1 diabetes experiencing HFI had higher fear of hypoglycemia scores (0.22 units higher for behavior, 0.55 units for worry, 0.40 units for total; all P < 0.0001) than those without HFI. No differences by HFI status were found for adolescents with type 1 diabetes. Parents of adolescents reporting HFI had a 0.18 unit higher worry score than those not reporting HFI (P < 0.05). Adults with type 2 diabetes experiencing HFI had higher fear of hypoglycemia scores (0.19 units higher for behavior, 0.35 units for worry, 0.28 units for total; all P < 0.05) than those in food secure households.CONCLUSIONSScreening for HFI and fear of hypoglycemia among people with diabetes can help providers tailor diabetes education for those who have HFI and therefore fear hypoglycemia.

BACKGROUND: Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease. Particulate matter air pollution

Although household food insecurity (HFI) has been associated with depressive symptoms in youth and young adults (YYA) with youth-onset diabetes, little is known about the association of HFI with other mental health comorbidities. We examined the association of HFI with stress and anxiety symptoms among YYA with diabetes using cross-sectional data from the SEARCH Food Security Cohort study (assessments conducted 2018-2020; n = 1030, age =23.8± 0.3, female =58.8%, type 1 diabetes (T1D) = 881, type 2 diabetes (T2D) =149) . HFI was defined as 3+ affirmations on the USDA Household Food Security Survey Module. The Generalized Anxiety Disorder (GAD-7) and Cohen’s Perceived Stress Scale (PSS-14) were used to assess outcomes of anxiety (score range 0-21) and stress (score range 0-56) , higher scores indicating greater anxiety or stress. Linear regression models were adjusted for age, sex, race/ethnicity, site, diabetes duration, parental education, income, and whether assessment was completed pre/post the coronavirus pandemic. Analyses were stratified by diabetes type. HFI was present in 17.3% of T1D and 35.6 % of T2D. Moderate/severe anxiety symptom scores (range 10-21) were found in 27.5 % (mean=6.9, s.d. =5.5) of T1D and 40.9% (mean=8.4, s.d. =6.5) of T2D. Mean stress scores were 26.7 (s.d.=6.3) for T1D and 27.9 (s.d.=6.3) for T2D. In T1D, HFI was associated with higher anxiety (β=4.8, p= Disclosure A.D.Brown: n/a. S.M.Marcovina: None. C.Pihoker: None. A.D.Liese: None. J.A.Mendoza: None. E.A.Frongillo: None. K.Flory: None. B.A.Reboussin: None. E.T.Jensen: Consultant; Regeneron Pharmaceuticals Inc. L.M.Dolan: None. A.Bellatorre: None. F.Malik: n/a. Funding NIH/NIDDK (1R01DK117461-01) ; NIH/NIDDK/CDC (1UC4DK108173) ; NIH/NIGMS (T32-GM081740)

Introduction This post hoc subset analysis of RESPOND evaluated the effectiveness of dimethyl fumarate (DMF) 240 mg twice daily in patients with relapsing multiple sclerosis (RMS) after suboptimal response to glatiramer acetate (GA; “first switch” patients), including patients with early MS (“early MS switch” patients). Methods Patients had discontinued GA due to suboptimal response and initiated DMF treatment within 60 days after enrollment. Relapse data were collected from medical records. First switch patients had had one prior approved MS therapy (GA) before initiating DMF treatment. Early MS switch patients were first switch patients with baseline Patient-Reported Expanded Disability Status Scale (PR-EDSS) score ≤ 3.5, ≤ 1 relapses in the past 1 year, or both. Results Among first switch patients (n = 231), the annualized relapse rate (ARR) was 0.48 (95% confidence interval [CI] 0.40–0.58) for 12 months before DMF initiation and 0.11 (95% CI 0.06–0.18) for 12 months after DMF initiation, a 78% decrease in ARR. Among early MS switch patients with baseline PR-EDSS score ≤ 3.5 (n = 120), ≤ 1 relapses in the prior year (n = 219), or both (n = 114), the ARRs (95% CIs) for 12 months before DMF initiation were 0.47 (0.37–0.59), 0.37 (0.32–0.44), and 0.39 (0.31–0.49), respectively; values for 12 months after DMF initiation were 0.06 (0.02–0.19), 0.09 (0.05–0.17), and 0.06 (0.02–0.20), respectively, an 87, 75, and 83% decrease in ARR. The proportion of patients relapse-free 12 months after DMF initiation versus 12 months before were 94 versus 59% in first switch patients, and 97 versus 58%, 94 versus 63%, and 97 versus 61% in early MS switch patients in the PR-EDSS score ≤ 3.5, ≤ 1 relapses in the prior year, or PR-EDSS score ≤ 3.5 and ≤ 1 relapses subgroups, respectively. After 12 months of DMF treatment, most patient-reported outcomes scores showed significant improvement. Conclusions DMF may be an effective treatment option in first switch and early MS switch patients with RMS who experience a suboptimal response to GA. Trial Registration ClinicalTrials.gov identifier: NCT01903291. Electronic supplementary material The online version of this article (10.1007/s40120-020-00223-2) contains supplementary material, which is available to authorized users.

Objective Health inequities persist in youth and young adults (YYA) with type 1diabetes in achieving optimal glycemic control. The purpose of this study was to assess the contribution of multiple indicators of social need to these inequities. Research design and methods Two hundred and twenty two YYA withtype 1 diabetes enrolled in the SEARCH Food Insecurity Study in South Carolina and Washington between the years 2013 and 2015 were included. Latent class analysis was used to identify socioeconomic profiles based on household income, parental education, health insurance, household food insecurity, and food assistance. Profiles were evaluated in relation to glycemic control using multivariable linear and logistic regression, with HbA1c > 9%(75 mmol/mol) defined as high-risk glycemic control. Results Two profiles were identified: a lower socioeconomic profile included YYA whose parents had lower income and/or education, and were more likely to be uninsured, receive food assistance, and be food insecure. A higher socioeconomic profile included YYA whose circumstances were opposite to those in the lower socioeconomic profile. Those with a lower socioeconomic profile were more likely to have high-risk glycemic control relative to those with a higher socioeconomic profile (OR = 2.24, 95%CI = 1.16-4.33). Conclusions Lower socioeconomic profiles are associated with high-risk glycemic control among YYA with type 1 diabetes. This supports recommendations that care providers of YYA with type 1 diabetes assess individual social needs in tailoring diabetes management plans to the social context of the patient.

Background: Delayed-release dimethyl fumarate (DMF) demonstrates sustained efficacy and safety for relapsing forms of MS. Absolute lymphocyte count (ALC) is reduced initially, then stabilizes on treatment. Objective: PROCLAIM, a 96-week, prospective, open-label, phase 3b study, assessed lymphocyte subsets and immunoglobulin (Ig) levels during 48 and 96 weeks (W) of DMF treatment. Methods: Patients received 240 mg DMF BID. Endpoints: lymphocyte subset count changes (primary); Ig isotypes and ALC changes (secondary); adverse events and relationship between ALC changes and ARR/EDSS (exploratory); and neurofilament assessment (ad hoc). Results: Of 218 patients enrolled, 158 (72%) completed the study. Median ALC decreased 39% from baseline to W96 (BL–W96), stabilizing above the lower limit of normal (baseline: 1.82 × 109/L; W48: 1.06 × 109/L; W96: 1.05 × 109/L). CD4 + and CD8 + T cells correlated highly with ALC from BL–W96 ( p + and CD8 + T cells increased, whereas CD4 + and CD8 + central and effector memory T cells decreased. Total IgA, IgG, IgM, and IgG1–4 subclass levels remained stable. Adverse event rates were similar across ALC subgroups. ARR, EDSS, and neurofilament were not correlated with ALCs. Conclusion: Lymphocyte decreases with DMF were maintained over treatment, yet immunoglobulins remained stable. No increase in infection incidence was observed in patients with or without lymphopenia. Support: Biogen

Introduction Black or African American (black/AA) patients with multiple sclerosis (MS) are reported to exhibit greater disease severity compared with non-black or non-AA patients. Whether differences exist in response to MS disease-modifying therapies remains uncertain, as MS clinical trials have included low numbers of non-white patients. We evaluated real-world safety and effectiveness of dimethyl fumarate (DMF) on MS disease activity in black/AA patients. Methods ESTEEM is an ongoing, 5-year, multinational, prospective study evaluating long-term safety and effectiveness of DMF in patients with MS. This interim analysis included patients newly prescribed DMF in routine practice at 394 sites globally. Results Overall, 4897 non-black/non-AA and 187 black/AA patients were analyzed; median (range) follow-up 18 (2–37) months. Unadjusted annualized relapse rates (ARRs) for 12 months before DMF initiation versus 36 months post DMF initiation, respectively, were: non-black/non-AA patients, 0.83 (95% CI 0.80–0.85) versus 0.10 (95% CI 0.09–0.10), 88% lower ARR (P

Introduction Compared with the non-Hispanic/non-Latino population, Hispanic/Latino patients with multiple sclerosis (MS) are reported to exhibit greater disease severity. Geographical location and genetics play a role in differences observed across Hispanic/Latino subpopulations. We evaluated real-world safety and effectiveness of dimethyl fumarate (DMF) on MS disease activity in Hispanic/Latino patients. Methods ESTEEM is an ongoing, 5-year, multinational, prospective study evaluating long-term safety and effectiveness of DMF in patients with MS. This interim analysis included patients newly prescribed DMF in routine practice at 394 sites globally. Results Overall, 4986 non-Hispanic/non-Latino and 98 Hispanic/Latino patients were analyzed; median (range) follow-up was 18 (2–37) months. Unadjusted annualized relapse rates (ARRs) for 12 months before DMF initiation versus 36 months post DMF initiation, respectively, were: non-Hispanic/non-Latino patients, 0.82 (95% CI 0.80–0.84) versus 0.10 (95% CI 0.09–0.10), 88% lower ARR (P

To examine the association between household food insecurity (HFI), glycemic control, severe hypoglycemia and diabetic ketoacidosis (DKA) among youth and young adults (YYA) with youth-onset type 2 diabetes.This cross-sectional study included 395 YYA with type 2 diabetes from the SEARCH for Diabetes in Youth Study (2015-2019). HFI was reported by young adult participants or parents of minor participants via the US Household Food Security Survey Module. Glycemic control was assessed by HbAApproximately 31% reported HFI in the past 12 months. Mean HbAHFI was associated with markedly increased odds of DKA but not with glycemic control or severe hypoglycemia. Future research among YYA with type 2 diabetes should evaluate longitudinally whether alleviating HFI reduces DKA.

Background: Food insecurity (FI) has been associated with poor access to health care. It is unclear whether this association is beyond that predicted by income, education, and health insurance. FI may serve as a target for intervention given the many programs designed to ameliorate FI. We examined the association of FI with being up-to-date to colorectal cancer and breast cancer screening guidelines. Methods: Nine NCI-designated cancer centers surveyed adults in their catchment areas using demographic items and a two-item FI questionnaire. For the colorectal cancer screening sample (n = 4,816), adults ages 50–75 years who reported having a stool test in the past year or a colonoscopy in the past 10 years were considered up-to-date. For the breast cancer screening sample (n = 2,449), female participants ages 50–74 years who reported having a mammogram in the past 2 years were up-to-date. We used logistic regression to examine the association between colorectal cancer or breast cancer screening status and FI, adjusting for race/ethnicity, income, education, health insurance, and other sociodemographic covariates. Results: The prevalence of FI was 18.2% and 21.6% among colorectal cancer and breast cancer screening participants, respectively. For screenings, 25.6% of colorectal cancer and 34.1% of breast cancer participants were not up-to-date. In two separate adjusted models, FI was significantly associated with lower odds of being up-to-date with colorectal cancer screening [OR, 0.7; 95% confidence interval (CI), 0.5–0.99)] and breast cancer screening (OR, 0.6; 95% CI, 0.4–0.96). Conclusions: FI was inversely associated with being up-to-date for colorectal cancer and breast cancer screening. Impact: Future studies should combine FI and cancer screening interventions to improve screening rates.

Infections in people with multiple sclerosis (PwMS) may have a detrimental effect on disease progression, risk of hospitalization, and healthcare resource utilization (HRU). The infection risk and HRU costs may vary between disease-modifying therapies (DMTs); however, the individual risks and differences associated with DMTs are not well characterized. Some DMTs may increase the risk for infections in PwMS; however, previous studies have reported an intact humoral immune response in dimethyl fumarate (DMF)-treated patients. The objective was to compare infection-related HRU and healthcare costs (HCCs) between PwMS treated with DMF or ocrelizumab (OCR).Eligible patients were identified from the Optum US claims database between April 2017 and September 2020 (DMF n = 1429; OCR n = 3170). Patients were followed from index date to first occurrence of: (1) end of study, (2) end of insurance eligibility, (3) discontinuation of index DMT, or (4) switch from index DMT to another DMT. Outcomes were annualized rate of infection encounters (defined as infection encounters [n] during follow-up window / days followed [n] × 365); annualized infection-related HCCs (defined as aggregated costs of infection encounters during follow-up window / days followed [n] × 365); location-specific infections, and overall infection-related events. Propensity score matching (PSM) 1:1 method was used; PS was calculated via logistic regression for probability of DMF treatment conditional on demographics and comorbidities. Mean differences (MD) were reported for infection encounter measures.After PSM, DMF and OCR cohorts (n = 1094 in each cohort) were balanced based on baseline characteristics (standardized MD of adjusted baseline characteristics0.1). Mean (standard deviation) follow-up was 296 (244) days for DMF patients and 297 (243) for OCR patients. DMF patients experienced lower annualized rates of overall infection encounters vs OCR patients (MD -0.51 [95% confidence interval (CI): -0.92 to -0.11], p = 0.01). When stratified by type of infection encounter, DMF patients experienced significantly lower annualized rates of outpatient (MD [95% CI]: -0.44 [-0.80 to -0.08], p = 0.02) and inpatient/hospitalization infection encounters (-0.08 [-0.14 to -0.02], p0.01) vs OCR patients. A trend towards a shorter duration of infection-related hospitalization in the DMF vs the OCR group was observed (MD [95% CI]: -2.20 [-4.73 to 0.26] days, p = 0.08). The most common infection types in both DMT groups were urinary tract infections, sepsis, and pneumonia. DMF patients experienced lower annualized infection-related HCCs (MD [95% CI]: -$3642 [-$6380 to -$904], p0.01) vs OCR patients, which were driven largely by infection-related hospitalization costs (-$3639 [-$6019 to -$1259], p0.01).DMF-treated patients PS-matched with OCR patients experienced lower annualized rates of infection encounters and lower infection-related HCCs.

Background: Rural populations experience a disproportionate cancer burden relative to urban populations. One possibility is that rural populations are more likely to hold counterproductive cancer beliefs such as fatalism and information overload that undermine prevention and screening behaviors. Methods: Between 2016 and 2020, 12 U.S. cancer centers surveyed adults in their service areas using online and in-person survey instruments. Participants (N = 10,362) were designated as rural (n = 3,821) or urban (n = 6,541). All participants were 18 and older (M = 56.97, SD = 16.55), predominately non-Hispanic White (81%), and female (57%). Participants completed three items measuring cancer fatalism (“It seems like everything causes cancer,” “There's not much you can do to lower your chances of getting cancer,” and “When I think about cancer, I automatically think about death”) and one item measuring cancer information overload (“There are so many different recommendations about preventing cancer, it's hard to know which ones to follow”). Results: Compared with urban residents, rural residents were more likely to believe that (i) everything causes cancer (OR = 1.29; 95% CI, 1.17–1.43); (ii) prevention is not possible (OR = 1.34; 95% CI, 1.19–1.51); and (iii) there are too many different recommendations about cancer prevention (OR = 1.26; 95% CI, 1.13–1.41), and cancer is always fatal (OR = 1.21; 95% CI, 1.11–1.33). Conclusions: Compared with their urban counterparts, rural populations exhibited higher levels of cancer fatalism and cancer information overload. Impact: Future interventions targeting rural populations should account for higher levels of fatalism and information overload.

Diroximel fumarate (DRF) is an oral fumarate for relapsing multiple sclerosis (MS) with the same active metabolite as dimethyl fumarate (DMF). DRF has a safety/efficacy profile similar to DMF but with improved gastrointestinal (GI) tolerability and low ( 1%) treatment discontinuation due to GI adverse events (AEs). Efficacy and safety outcomes in patients who switched to DRF from other disease-modifying therapies (DMTs) have not been evaluated.EVOLVE-MS-1 is an ongoing, 2-year, open-label, phase 3 study of DRF in adults with relapsing-remitting MS. Patients either entered as newly enrolled to DRF trials, or from the 5-week, randomized, head-to-head, phase 3 EVOLVE-MS-2 study of DRF and DMF. This analysis evaluated safety and GI tolerability in patients continuing on DRF (DRF-rollover) or switching from DMF (DMF-rollover) following EVOLVE-MS-2. Safety and efficacy were evaluated in a subset of newly enrolled patients who had received prior glatiramer acetate (GA; GA/DRF) or interferons (IFN; IFN/DRF) as their most recent DMT, prior to switching to DRF in EVOLVE-MS-1.As of September 1, 2020, 1057 patients were enrolled in EVOLVE-MS-1, including 166, 182, 239, and 225 patients in the GA/DRF, IFN/DRF, DRF-rollover, and DMF-rollover groups, respectively. Treatment discontinuation due to GI AEs was 1% in all groups. GA/DRF and IFN/DRF patients experienced improvements from baseline in clinical and radiological efficacy outcomes, including significantly reduced annualized relapse rates. Rollover patients had low rates of new or recurrent GI AEs (DRF-rollover, 26.8%/4.2%; DMF-rollover, 27.1%/4.9%).After 2 years of DRF exposure, patients with prior GA, IFN, or fumarate treatment had safety outcomes consistent with previous fumarate studies. Efficacy in patients with prior GA or IFN treatment was consistent with previous fumarate studies. The data suggest that transition to DRF from GA, IFN, or DMF is a reasonable treatment strategy, with low rates of discontinuation due to GI AEs.ClinicalTrials.gov (NCT02634307). INFOGRAPHIC.

Background Television viewing among children is associated with developmental and health outcomes, yet measurement techniques for television viewing are prone to errors, biases, or both. Objective This study aims to develop a system to objectively and passively measure children’s television viewing time. Methods The Family Level Assessment of Screen Use in the Home-Television (FLASH-TV) system includes three sequential algorithms applied to video data collected in front of a television screen: face detection, face verification, and gaze estimation. A total of 21 families of diverse race and ethnicity were enrolled in 1 of 4 design studies to train the algorithms and provide proof of concept testing for the integrated FLASH-TV system. Video data were collected from each family in a laboratory mimicking a living room or in the child’s home. Staff coded the video data for the target child as the gold standard. The accuracy, sensitivity, specificity, positive predictive value, and negative predictive value were calculated for each algorithm, as compared with the gold standard. Prevalence and biased adjusted κ scores and an intraclass correlation using a generalized linear mixed model compared FLASH-TV’s estimation of television viewing duration to the gold standard. Results FLASH-TV demonstrated high sensitivity for detecting faces (95.5%-97.9%) and performed well on face verification when the child’s gaze was on the television. Each of the metrics for estimating the child’s gaze on the screen was moderate to good (range: 55.1% negative predictive value to 91.2% specificity). When combining the 3 sequential steps, FLASH-TV estimation of the child’s screen viewing was overall good, with an intraclass correlation for an overall time watching television of 0.725 across conditions. Conclusions FLASH-TV offers a critical step forward in improving the assessment of children’s television viewing.

Background There is a strong association between increased mobile device use and worse dietary habits, worse sleep outcomes, and poor academic performance in children. Self-report or parent-proxy report of children’s screen time has been the most common method of measuring screen time, which may be imprecise or biased. Objective The objective of this study was to assess the feasibility of measuring the screen time of children on mobile devices using the Family Level Assessment of Screen Use (FLASH)–mobile approach, an innovative method that leverages the existing features of the Android platform. Methods This pilot study consisted of 2 laboratory-based observational feasibility studies and 2 home-based feasibility studies in the United States. A total of 48 parent-child dyads consisting of a parent and child aged 6 to 11 years participated in the pilot study. The children had to have their own or shared Android device. The laboratory-based studies included a standardized series of tasks while using the mobile device or watching television, which were video recorded. Video recordings were coded by staff for a gold standard comparison. The home-based studies instructed the parent-child dyads to use their mobile device as they typically use it over 3 days. Parents received a copy of the use logs at the end of the study and completed an exit interview in which they were asked to review their logs and share their perceptions and suggestions for the improvement of the FLASH-mobile approach. Results The final version of the FLASH-mobile approach resulted in user identification compliance rates of >90% for smartphones and >80% for tablets. For laboratory-based studies, a mean agreement of 73.6% (SD 16.15%) was achieved compared with the gold standard (human coding of video recordings) in capturing the target child’s mobile use. Qualitative feedback from parents and children revealed that parents found the FLASH-mobile approach useful for tracking how much time their child spends using the mobile device as well as tracking the apps they used. Some parents revealed concerns over privacy and provided suggestions for improving the FLASH-mobile approach. Conclusions The FLASH-mobile approach offers an important new research approach to measure children’s use of mobile devices more accurately across several days, even when the child shares the device with other family members. With additional enhancement and validation studies, this approach can significantly advance the measurement of mobile device use among young children.