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INTRODUCTION: Whereas marginal food insecurity has been recognized as important in Canadian food security policy, the category of marginal food security (MFS) is often ignored in US food security research. METHODS: Prevalence of FI was estimated according to the conventional and an alternate classification of MFS with food insecurity among 938 youth and young adults (YYA) with youth-onset type 1 diabetes (T1D) and 156 with youth-onset of type 2 diabetes (T2D) from the SEARCH Food Security Cohort Study (2018-2021). Multivariable regression was used to estimate the association of MFS and conventionally defined food insecurity (FI) ascertained with diabetes-related outcomes, including acute diabetes complications, health care utilization, and diabetes self-management among YYA with T1D. RESULTS: MFS affected 10% of participants with T1D diabetes and 20% of participants with T2D. Classifying MFS with FI increased FI prevalence from 18.0% to 27.8% in participants with T1D and 34.6% to 55.1% in participants with T2D. Compared to T1D with high food security, YYA with T1D who were FI had higher odds hypoglycemia (2.1, 95%CI 1.2-3.6) and ketoacidosis (1.6, 95%CI 1.0-2.6), but no association was seen in MFS. The FI group also had higher odds of emergency department use and hospitalization (2.3, 95%CI 1.5-3.4; 2.4, 95%CI 1.5-3.9) and lower odds of technology use and checking glucose (0.6, 95%CI 0.4-0.9; 0.3, 95%CI 0.1-0.6). The MFS group exhibited associations of similar directions. DISCUSSION AND CONCLUSIONS: Health care providers should consider care of patients with T1D and MFS the same way they care for patients with FI.
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OBJECTIVE: Parent behavior management training (BMT) is an evidence-based yet underutilized tool to treat children with ADHD and address related health disparities. This pilot study investigated the acceptability and feasibility of a novel, health behavior-, and technology-adapted BMT (LEAP) vs. standard BMT. METHODS: The weekly 9-session LEAP telemedicine group program is based on a standard BMT curriculum enhanced with strategies for supporting optimal child sleep, problematic media use (PMU), and physical activity, including wrist-worn activity trackers. Children ages 6-10 years with ADHD and their caregivers were randomized to LEAP or standard BMT. Acceptability and feasibility were tracked. Caregivers completed standardized measures, and children wore hip-worn accelerometers for 1 week at baseline, postintervention (10 weeks), and follow-up (20 weeks). RESULTS: 84 parent/child dyads were randomized to LEAP or standard BMT, with high and comparable acceptability and feasibility. Both treatment groups demonstrated decreased ADHD symptoms and improved executive functions postintervention (p < .0001), maintained at follow-up. Average accelerometer-measured MVPA decreased and sleep duration remained unchanged, while PMU and bedtime resistance improved for both groups. CONCLUSIONS: LEAP is highly feasible and acceptable, and yielded similar initial clinical and health behavior improvements to standard BMT. Innovative and targeted supports are needed to promote healthy behaviors in children with ADHD.
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Transtorno do Deficit de Atenção com Hiperatividade , Comportamentos Relacionados com a Saúde , Pais , Telemedicina , Humanos , Transtorno do Deficit de Atenção com Hiperatividade/terapia , Projetos Piloto , Criança , Masculino , Feminino , Pais/educação , Estudos de Viabilidade , Currículo , Terapia Comportamental/métodos , AdultoRESUMO
BACKGROUND: Social risk such as housing instability, trouble affording medical care and food insecurity are a downstream effect of social determinants of health (SDOHs) and are frequently associated with worse health. SDOHs include experiences of racism, sexism and other discrimination as well as differences in income and education. The collective effects of each social risk a person reports are called cumulative social risk. Cumulative social risk has traditionally been measured through counts or sum scores that treat each social risk as equivalent. We have proposed to use item response theory (IRT) as an alternative measure of person-reported cumulative social risk as IRT accounts for the severity in each risk and allows for more efficient screening with computerized adaptive testing. METHODS: We conducted a differential item functioning (DIF) analysis comparing IRT-based person-reported cumulative social risk scores by income and education in a population-based sample (n = 2122). Six social risk items were analyzed using the two-parameter logistic model and graded response model. RESULTS: Analyses showed no DIF on an IRT-based cumulative social risk score by education level for the six items examined. Statistically significant DIF was found on three items by income level but the ultimate effect on the scores was negligible. CONCLUSIONS: Results suggest an IRT-based cumulative social risk score is not biased by education and income level and can be used for comparisons between groups. An IRT-based cumulative social risk score will be useful for combining datasets to examine policy factors affecting social risk and for more efficient screening of patients for social risk using computerized adaptive testing.
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Escolaridade , Renda , Determinantes Sociais da Saúde , Humanos , Feminino , Masculino , Pessoa de Meia-Idade , Adulto , Viés , Idoso , Racismo , AutorrelatoRESUMO
In the abstract cited above, author Nadine El Kalach was inadvertently omitted from the author list. The full, correct author list is as follows: Nadine El Kalach, Emmanuel F. Julceus, Caroline Rudisill, Faisal Malik, Kate Flory, Edward A. Frongillo, Katherine A. Sauder, Jason A. Mendoza, and Angela D. Liese. All authors approve the addition and the order of the revised author list. The authors apologize for the omission. The online version of the abstract (https://doi.org/10.2337/db24-189-OR) has been updated to correct the error.
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BACKGROUND: Interventions to increase physical activity are needed in adolescent and young adult survivors of childhood cancer who are largely inactive but at lifelong elevated risk of multiple chronic conditions improved by physical activity. The goals of the StepByStep study are to evaluate the effects of a 48-week distance-based, multi-component mobile health and social media behavioral intervention on physical activity, biomarkers of cardiometabolic health, and health-related quality of life. METHODS: This ongoing study is a two-arm, prospective, multi-site randomized controlled trial. 384 childhood cancer survivors age ≥ 15 years and < 21 years who were 3-36 months off therapy and not meeting physical activity guidelines were enrolled. The trial will test the efficacy of a 24-week intensive multi-component physical activity intervention combining a wearable physical activity tracker, social media peer support group, and individualized goal setting followed by a 24-week maintenance phase of the intervention to improve outcomes. The control group receives the wearable physical activity tracker only. CONCLUSION: There is a growing need for novel, developmentally appropriate interventions to increase physical activity and improve the health trajectory of adolescent and young adult survivors of childhood cancer. If efficacious, this portable and scalable intervention would be a much-needed tool to reduce the morbidity from cancer treatment and improve quality of life among survivors after treatment ends. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04089358; COG Identifier: ALTE2031.
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Sobreviventes de Câncer , Exercício Físico , Qualidade de Vida , Mídias Sociais , Telemedicina , Humanos , Adolescente , Sobreviventes de Câncer/psicologia , Adulto Jovem , Masculino , Feminino , Estudos Prospectivos , Neoplasias/terapia , Neoplasias/psicologia , Monitores de Aptidão Física , Projetos de PesquisaRESUMO
OBJECTIVE: Evaluate the real-world effect of dimethyl fumarate (DMF) on subclinical biomarkers in patients with relapsing-remitting multiple sclerosis (RRMS) and compare with results from clinical trials. METHODS: Magnetic resonance imaging (MRI) data from 102 RRMS patients were retrospectively collected and processed using icobrain to assess brain atrophy and to assist semi-manual lesion count. RESULTS: Mean (±SD) annualized percent brain volume change in the first 3 years after DMF-initiation were: -0.33 ± 0.68, -0.10 ± 0.60, and - 0.35 ± 0.71%/year, respectively. No new FLAIR lesions were detected in 73.7%, 77.3%, and 73.3% of the patients during years 1, 2, and 3. CONCLUSIONS: Results of this real-world study were consistent with previous DMF phase III clinical trials, supporting the generalizability of the effects observed in clinical trials to the real-world clinical setting.
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Biomarcadores , Fumarato de Dimetilo , Imunossupressores , Imageamento por Ressonância Magnética , Esclerose Múltipla Recidivante-Remitente , Humanos , Fumarato de Dimetilo/uso terapêutico , Feminino , Masculino , Esclerose Múltipla Recidivante-Remitente/tratamento farmacológico , Esclerose Múltipla Recidivante-Remitente/diagnóstico por imagem , Adulto , Pessoa de Meia-Idade , Imunossupressores/uso terapêutico , Biomarcadores/sangue , Estudos Retrospectivos , Estudos de Coortes , Encéfalo/diagnóstico por imagem , Encéfalo/efeitos dos fármacos , Encéfalo/patologiaRESUMO
INTRODUCTION: Switching disease-modifying therapy (DMT) may be considered for relapsing-remitting multiple sclerosis (RRMS) if a patient's current therapy is no longer optimal. This was particularly important during the recent COVID-19 pandemic because of considerations around immune deficiency and impaired vaccine response associated with B cell-depleting DMTs. This real-world, single-center study aimed to evaluate change or decline in functional ability and overall disease stability in people with RRMS who were switched from B cell-depleting ocrelizumab (OCRE) to diroximel fumarate (DRF) because of safety concern related to the COVID-19 pandemic. METHODS: Adults with RRMS were included if they had been clinically stable for ≥ 1 year on OCRE. Data collected at baseline and 1 year post switch included relapse rate, magnetic resonance imaging (MRI), blood work for assessment of peripheral immune parameters, the Cognitive Assessment Battery (CAB), optical coherence tomography (OCT), and patient-reported outcomes (PROs). RESULTS: Participants (N = 25) had a mean (SD) age of 52 (9) years, and a mean (SD) duration of 26 (8) months' treatment with OCRE before the switch to DRF. Median washout duration since the last OCRE infusion was 7 months (range 4-18 months). No participants relapsed on DRF during follow-up, and all remained persistent on DRF after 1 year. There were no significant changes in peripheral immune parameters, other than an increase in the percentage of CD19+ cells 1 year after switching (p < 0.05). Similarly, there were no significant changes in CAB, OCT, and PROs. CONCLUSION: These preliminary findings suggest that transition to DRF from OCRE may be an effective treatment option for people with RRMS who are clinically stable but may need to switch for reasons unrelated to effectiveness. Longer follow-up times on larger samples are needed to confirm these observations.
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Anticorpos Monoclonais Humanizados , Esclerose Múltipla Recidivante-Remitente , Humanos , Masculino , Feminino , Anticorpos Monoclonais Humanizados/uso terapêutico , Anticorpos Monoclonais Humanizados/efeitos adversos , Adulto , Pessoa de Meia-Idade , Esclerose Múltipla Recidivante-Remitente/tratamento farmacológico , Fatores Imunológicos/uso terapêutico , Fatores Imunológicos/efeitos adversos , Fumarato de Dimetilo/uso terapêutico , Fumarato de Dimetilo/efeitos adversos , Resultado do Tratamento , COVID-19 , Substituição de Medicamentos , SARS-CoV-2RESUMO
INTRODUCTION: In EVOLVE-MS-1 (NCT02634307), mean absolute lymphocyte count (ALC) on diroximel fumarate (DRF) declined from baseline by approximately 28% in year 1, then stabilized, similar to ALC decline observed with dimethyl fumarate (DMF). Prior studies reported that clinical efficacy of DMF was not substantially different in patients with and without lymphopenia. METHODS: EVOLVE-MS-1-an open-label, 96-week, phase 3 study-assessed DRF safety and exploratory efficacy in patients with relapsing-remitting multiple sclerosis. This study analyzes efficacy-related outcomes comparing (1) patients with lymphopenia (≥ 1 ALC below lower limit of normal [LLN]) and without (all ALCs ≥ LLN); (2) across quartiles stratified by week 96 ALC decline from baseline: Q1 (≥ 47% decline); Q2 (30% to < 47% decline); Q3 (12% to < 30% decline); Q4 (< 12% decline). RESULTS: Baseline characteristics were similar between patients without (n = 593) and with lymphopenia (n = 452). At week 96, adjusted annualized relapse rate (ARR; 95% confidence interval) was 0.14 (0.11-0.17) without lymphopenia and 0.12 (0.09-0.15) with lymphopenia. Estimated proportions with 12-week confirmed disability progression (CDP12) at week 96 were 10.2% without and 9.3% with lymphopenia. When stratified by quartiles (Q1-Q4), ARR at week 96 was 0.11 (Q1), 0.09 (Q2), 0.13 (Q3), and 0.17 (Q4). Estimated proportions with CDP12 at week 96 were 9.6% (Q1), 10.2% (Q2), 5.7% (Q3), and 10.9% (Q4). At week 96, no evidence of disease activity was achieved by 47.2% (Q1), 47.8% (Q2), 45.4% (Q3), and 37.3% (Q4) of patients. CONCLUSION: In DRF-treated patients in EVOLVE-MS-1, clinical and radiological measurements indicated reduced disease activity regardless of lymphopenia or magnitude of ALC decline from baseline; however, patients who had greater ALC declines appeared to have numerically lower ARR and higher proportions free from relapses and gadolinium-enhancing lesions compared with those with smallest decline. This supports prior evidence that, while lymphopenia may contribute to fumarate efficacy outcomes, it is not the primary mechanism of action. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02634307.
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BACKGROUND: The purpose of this study was to investigate the effects of a walking school bus intervention on children's active commuting to school. METHODS: We conducted a randomized controlled trial (RCT) in Houston, Texas (Year 1) and Seattle, Washington (Years 2-4) from 2012 to 2016. The study had a two-arm, cluster randomized design comparing the intervention (walking school bus and education materials) to the control (education materials) over one school year October/November - May/June). Twenty-two schools that served lower income families participated. Outcomes included percentage of days students' active commuting to school (primary, measured via survey) and moderate-to-vigorous physical activity (MVPA, measured via accelerometry). Follow-up took place in May or June. We used linear mixed-effects models to estimate the association between the intervention and outcomes of interest. RESULTS: Total sample was 418 students [Mage=9.2 (SD = 0.9) years; 46% female], 197 (47%) in the intervention group. The intervention group showed a significant increase compared with the control group over time in percentage of days active commuting (ß = 9.04; 95% CI: 1.10, 16.98; p = 0.015) and MVPA minutes/day (ß = 4.31; 95% CI: 0.70, 7.91; p = 0.02). CONCLUSIONS: These findings support implementation of walking school bus programs that are inclusive of school-age children from lower income families to support active commuting to school and improve physical activity. TRAIL REGISTRATION: This RCT is registered at clinicaltrials.gov (NCT01626807).
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Instituições Acadêmicas , Meios de Transporte , Caminhada , Humanos , Caminhada/estatística & dados numéricos , Feminino , Masculino , Criança , Meios de Transporte/métodos , Promoção da Saúde/métodos , Washington , Texas , Estudantes , Exercício Físico , Veículos Automotores , Acelerometria , Pobreza , Avaliação de Programas e Projetos de Saúde , Análise por ConglomeradosRESUMO
AIMS: To examine, among youth and young adults (YYA) with type 1 diabetes (T1D), the association of household food insecurity (HFI) with: 1) HbA1c and 2) episodes of diabetic ketoacidosis (DKA) and severe hypoglycemia. METHODS: HFI was assessed using the U.S. Household Food Security Survey Module in SEARCH for Diabetes in Youth participants with T1D between 2016 and 2019. Linear and logistic regression models adjusted for age, diabetes duration, sex, race, ethnicity, clinic site, parent/participant education, household income, health insurance, and diabetes technology use. RESULTS: Of 1830 participants (mean age 20.8 ± 5.0 years, 70.0 % non-Hispanic White), HbA1c was collected for 1060 individuals (mean HbA1c 9.2 % ± 2.0 %). The prevalence of HFI was 16.4 %. In the past 12 months, 18.2 % and 9.9 % reported an episode of DKA or severe hypoglycemia, respectively. Compared to participants who were food secure, HFI was associated with a 0.33 % (95 % CI 0.003, 0.657) higher HbA1c level. Those with HFI had 1.58 (95 % CI 1.13, 2.21) times the adjusted odds of an episode of DKA and 1.53 (95 % CI 0.99, 2.37) times the adjusted odds of an episode of severe hypoglycemia as those without HFI. CONCLUSIONS: HFI is associated with higher HbA1c levels and increased odds of DKA in YYA with T1D.
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Diabetes Mellitus Tipo 1 , Insegurança Alimentar , Hemoglobinas Glicadas , Humanos , Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 1/epidemiologia , Diabetes Mellitus Tipo 1/complicações , Masculino , Hemoglobinas Glicadas/análise , Hemoglobinas Glicadas/metabolismo , Feminino , Adolescente , Adulto Jovem , Adulto , Hipoglicemia/epidemiologia , Hipoglicemia/sangue , Cetoacidose Diabética/epidemiologia , Cetoacidose Diabética/etiologia , Estudos Transversais , PrevalênciaRESUMO
PURPOSE: This study evaluates recent trends in substance-related visits among youth visiting children's hospitals. METHODS: We conducted a cross-sectional study of substance-related visits to pediatric hospitals within the Pediatric Health Information System database of youth aged 12-21 years from 2016 through 2021. Substance-related visits were defined as acute visits for International Classification of Diseases, 10th Revision Clinical Modification codes related to substance 'use', dependence, or overdoses for alcohol, cannabis, nicotine, opioids, sedatives, stimulants, hallucinogens, or other substances. Cumulative growth rate and stratified substance-related trends were calculated using generalized estimating equations. Predicted number of visits during the COVID-19 pandemic was generated using an auto-regressive time series analysis. RESULTS: There were 106,793 substance-related visits involving 84,632 youth. From 2016 to 2021, substance-related visits increased by 47.9% and increased across all ages, demographics, regions, and payors. Visits of Hispanic youth experienced the greatest percentage growth (63.3%, p < .05) when compared to Non-Hispanic (NH) White (46.2%) or NH Black (49.8%) youth. All substances except sedatives experienced an increase in growth in visits. Cannabis accounted for the largest percentage of visits (52.2%) and experienced the greatest percentage growth during the study period (82.4%, p < .001). During the pandemic, publicly insured, female, NH Black, and Hispanic youth experienced a greater-than-predicted number of substance-related visits. DISCUSSION: Substance-related visits to children's hospitals are increasing for all demographics and nearly all substances. There were substantial increases in visits for most minoritized youth with a disproportionate rise among Hispanic youth. Visits over the pandemic were concentrated among publicly insured, female, NH Black, and Hispanic youth. Equitable large-scale investment is needed to address the rising morbidity of substance use among adolescents.
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COVID-19 , Hospitais Pediátricos , Transtornos Relacionados ao Uso de Substâncias , Humanos , Adolescente , Feminino , Masculino , Estados Unidos/epidemiologia , Estudos Transversais , Transtornos Relacionados ao Uso de Substâncias/epidemiologia , Criança , COVID-19/epidemiologia , Adulto Jovem , Bases de Dados Factuais , SARS-CoV-2RESUMO
BACKGROUND: The Household Food Security Survey Module (HFSSM) was not tailored to people with chronic diseases or young adults (YAs). OBJECTIVES: We aim to evaluate whether the 18-item HFSSM meets assumptions underlying the scale among YAs with diabetes. METHODS: Data from 1887 YAs with youth-onset type 1 diabetes or type 2 diabetes were used from the SEARCH for Diabetes in Youth Study, 2016-2019, and on 925 who returned for the SEARCH Food Security Cohort Study, 2018-2021, all of whom had completed the HFSSM. Guttman scaling properties (affirmation of preceding less severe items) and Rasch model properties (probability to answer an item based on difficulty level) were assessed. RESULTS: Items 3 (balanced meals) and 6 (eating less than one should) were affirmed more frequently than expected (nonmonotonic response pattern). At 1.2%-3.5%, item nonresponse was rare among type 1 diabetes but higher among type 2 diabetes (range: 3.1%-10.6%). Items 9 (not eating the whole day) and 3 did not meet the Guttman scaling properties. Rasch modeling revealed that item 3 had the smallest difficulty parameter. INFIT indices suggested that some responses to item 3 did not match the pattern in the rest of the sample. Classifying household food insecurity (HFI) based on items 1 and 2 compared with other 2-item combinations, including item 3, revealed a substantial undercount of HFI ranging from 5% to 8% points. CONCLUSIONS: Use of the HFSSM among YAs with diabetes could potentially result in biased HFI reporting and affect estimates of HFI prevalence in this population.
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Diabetes Mellitus Tipo 1 , Diabetes Mellitus Tipo 2 , Adolescente , Humanos , Adulto Jovem , Estudos de Coortes , Abastecimento de Alimentos , Segurança AlimentarRESUMO
BACKGROUND: Physical activity (PA) is essential for optimal diabetes management. Household food insecurity (HFI) may negatively affect diabetes management behaviors. The purpose of this study was to cross-sectionally examine the association between HFI and PA in youth and young adults (YYA) with type 1 (N = 1998) and type 2 (N = 391) diabetes from the SEARCH for Diabetes in Youth Study. METHODS: HFI was measured with the US Household Food Security Survey Module. PA was measured with the International Physical Activity Questionnaire Short Form. Walking, moderate-intensity PA (excluding walking), vigorous-intensity PA, moderate- to vigorous-intensity PA, and total PA were estimated as minutes per week, while time spent sitting was assessed in minutes per day. All were modeled with median regression. Meeting PA guidelines or not was modeled using logistic regression. RESULTS: YYA with type 1 diabetes who experienced HFI spent more time walking than those who were food secure. YYA with type 2 diabetes who experienced HFI spent more time sitting than those who were food secure. CONCLUSIONS: Future research should examine walking for leisure versus other domains of walking in relation to HFI and use objective PA measures to corroborate associations between HFI and PA in YYA with diabetes.
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Diabetes Mellitus Tipo 2 , Humanos , Adolescente , Adulto Jovem , Estudos Transversais , Exercício Físico , Abastecimento de Alimentos , Insegurança AlimentarRESUMO
BACKGROUND: Typically, child exposure to food insecurity is assessed by caregiver reports of household food security. Child report has the potential for greater accuracy because it pertains only to the child whose experiences may differ from caregiver reports. OBJECTIVE: We assessed if adolescent-reported food insecurity was associated with levels of hemoglobin A1c (HbA1c), acute diabetes-related complications, depressive symptoms, and disordered eating behaviors in adolescents with type 1 diabetes, independently from household food security. METHODS: In a cross-sectional analysis of the multicenter SEARCH for Diabetes in Youth Cohort Study (phase 4, 2016-2019) including 601 adolescents aged 10-17 y with type 1 diabetes and their caregivers, household food security, and adolescent-reported food security were assessed using the 18-item Household Food Security Survey Module and the 6-item Child Food Security Assessment questionnaire. Age-stratified (10-13 and 14-17) regression models were performed to estimate independent associations, adjusting for sociodemographics, clinical factors, and household food security. RESULTS: Food insecurity was reported by 13.1% (n = 79) of adolescents and 15.6% (n = 94) of caregivers. Among adolescent-caregiver dyads, 82.5% (n = 496) of reports were concordant and 17.5% (n = 105) discordant, Cohen's κ= 0.3. Adolescent-reported food insecurity was not independently associated with HbA1c, diabetic ketoacidosis, and severe hypoglycemia, including in age-stratified analyses. Adolescent-reported food insecurity was independently associated with elevated odds of depressive symptoms [odds ratio (OR): 3.6; 95% confidence interval (CI): 1.3, 10.3] and disordered eating behaviors (OR: 2.5, 95% CI: 1.4, 4.6) compared with adolescents reporting food security; these associations remained in both age groups for disordered eating behaviors and in the older group for depressive symptoms. CONCLUSIONS: Adolescents with type 1 diabetes may experience food insecurity differently than caregivers. Adolescent-reported food insecurity was independently associated with depressive symptoms and disordered eating behaviors and thus may be an important attribute to assess in addition to household food security in adolescents with type 1 diabetes.
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Diabetes Mellitus Tipo 1 , Hemoglobina Falciforme , Saúde Mental , Criança , Humanos , Adolescente , Autorrelato , Diabetes Mellitus Tipo 1/complicações , Estudos de Coortes , Estudos Transversais , Características da Família , Abastecimento de Alimentos , Segurança AlimentarRESUMO
The immunomodulatory effects of disease-modifying therapies for multiple sclerosis might affect the immune response to vaccines for severe acute respiratory syndrome coronavirus 2. We analyzed the severe acute respiratory syndrome coronavirus 2-specific antibody response and lymphocyte profile before and after Ad26.COV2.S (Johnson & Johnson) vaccination in natalizumab-treated patients with multiple sclerosis. There was a 72-fold increase in mean anti-severe acute respiratory syndrome coronavirus 2 spike immunoglobulin G levels 4 weeks after vaccination and a 137-fold increase after 6 months. Other immune signals were within normal ranges. Natalizumab-treated patients with multiple sclerosis had a robust immune response to Ad26.COV2.S vaccine, and other immune signals were not significantly affected.
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We investigated the impact of dimethyl fumarate (DMF), an oral therapy for relapsing multiple sclerosis (MS), on blood microRNA (miRNA) signatures and neurofilament light (NFL) levels. DMF normalized miR-660-5p and modulated various miRNAs associated with the NF-kB pathway. These alterations reached a peak 4-7 months after treatment. Notably, particular miRNAs correlated with high or low NFL levels, implying their potential role as markers of treatment efficacy. Our findings broaden the understanding of DMF's immunomodulatory effects and may aid in predicting treatment responses.
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MicroRNAs , Esclerose Múltipla Recidivante-Remitente , Esclerose Múltipla , Humanos , Fumarato de Dimetilo/uso terapêutico , Imunossupressores/efeitos adversos , Esclerose Múltipla Recidivante-Remitente/tratamento farmacológico , Esclerose Múltipla Recidivante-Remitente/induzido quimicamente , Esclerose Múltipla/induzido quimicamente , RecidivaRESUMO
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.
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Carcinoma Hepatocelular , Hepatite C , Cirrose Hepática , Veteranos , Humanos , Carcinoma Hepatocelular/etnologia , Carcinoma Hepatocelular/mortalidade , Etnicidade , Hepacivirus , Hepatite C/complicações , Hepatite C/etnologia , Cirrose Hepática/complicações , Cirrose Hepática/etnologia , Neoplasias Hepáticas/etnologia , Neoplasias Hepáticas/mortalidade , Hepatopatia Gordurosa não Alcoólica/complicações , Hepatopatia Gordurosa não Alcoólica/patologia , Masculino , Feminino , Adulto , Pessoa de Meia-Idade , IdosoRESUMO
OBJECTIVE: ADHD is associated with suboptimal health behaviors including physical activity (PA). LEAP is a parent BMT group program enhanced to focus on health behaviors, integrated with mHealth technology. Little is known about implementing BMT via telemedicine "telegroups." METHODS: Children ages 5 to 10 with ADHD and their caregiver wore activity trackers and participated in an 8 to 9 week parent BMT and social media group emphasizing PA, sleep, and screen use. A 7-day child accelerometer-wear and parent and teacher measures were completed pre- and post-group. Groups were in-person prior to the COVID-19 pandemic and in telegroup format during the pandemic. RESULTS: Thirty-three families participated in person and 23 participated via virtual telegroup. Group attendance was superior for telegroup with equivalent satisfaction and skill use. Changes in health behavior and clinical outcomes were equivalent. CONCLUSIONS: LEAP is a feasible and novel BMT intervention that can be delivered in an accessible telegroup format with high participation and acceptability.
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Transtorno do Deficit de Atenção com Hiperatividade , COVID-19 , Telemedicina , Humanos , Criança , Transtorno do Deficit de Atenção com Hiperatividade/terapia , Pandemias , Pais/educação , Comportamentos Relacionados com a SaúdeRESUMO
INTRODUCTION: Dimethyl fumarate (DMF) showed favorable benefit-risk in patients with relapsing-remitting multiple sclerosis (MS) in phase 3 DEFINE and CONFIRM trials and in the ENDORSE extension study. Disease activity can differ in younger patients with MS compared with the overall population. METHODS: Randomized patients received DMF 240 mg twice daily or placebo (PBO; years 0-2 DEFINE/CONFIRM), then DMF (years 3-10; continuous DMF/DMF or PBO/DMF; ENDORSE); maximum follow-up (combined studies) was 13 years. This integrated post hoc analysis evaluated safety and efficacy of DMF in a subgroup of young adults aged 18-29 years. RESULTS: Of 1736 patients enrolled in ENDORSE, 125 were young adults, 86 treated continuously with DMF (DMF/DMF) and 39 received delayed DMF (PBO/DMF) in DEFINE/CONFIRM. Most (n = 116 [93%]) young adults completed DMF treatment in DEFINE/CONFIRM. Median (range) follow-up time in ENDORSE was 6.5 (2.0-10.0) years. Young adults entering ENDORSE who had been treated with DMF in DEFINE/CONFIRM had a model-based Annualized Relapse Rate (ARR; 95% CI) of 0.24 (0.16-0.35) vs. 0.56 (0.35-0.88) in PBO patients. ARR remained low in ENDORSE: 0.07 (0.01-0.47) at years 9-10 (DMF/DMF group). At year 10 of ENDORSE, EDSS scores were low in young adults: DMF/DMF, 1.9 (1.4); PBO/DMF, 2.4 (1.6). At ~ 7 years, the proportion of young adults with no confirmed disability progresion was 81% for DMF/DMF and 72% for PBO/DMF. Patient-reported outcomes (PROs) (SF-36 and EQ-5D) generally remained stable during ENDORSE. The most common adverse events (AEs) in young adults during ENDORSE were MS relapse (n = 53 [42%]). Most AEs were mild (n = 20 [23.3%], n = 7 [17.9%]) to moderate (n = 45 [52.3%], n = 23 [59.0%]) in the DMF/DMF and PBO/DMF groups, respectively. The most common serious AE (SAE) was MS relapse (n = 19 [15%]). CONCLUSION: The data support a favorable benefit-risk profile of DMF in young adults, as evidenced by well-characterized safety, sustained efficacy, and stable PROs. CLINICAL TRIAL INFORMATION: Clinical trials.gov, DEFINE (NCT00420212), CONFIRM (NCT00451451), and ENDORSE (NCT00835770).