Parent Behavior Management Training for Child ADHD Enhanced to Address Health Behaviors: Comparison of Telemedicine "Telegroup" Versus In-Person Delivery.

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.

Measuring the Impact of the COVID-19 Pandemic on Health Behaviors and Health Care Utilization in Rural and Urban Patients with Cancer and Cancer Survivors.

Healthcare access and health behaviors differ between those living in urban and rural communities and contribute to inequitable cancer health outcomes. The COVID-19 pandemic led to significant disruptions in daily life and healthcare delivery. This cross-sectional survey aimed to measure the impact of the COVID-19 pandemic on the health behaviors of cancer patients and survivors, comparing outcomes for urban and rural respondents. Survey was administered from January 2021-June 2021 to cancer patients or survivors (treated within the last 5 years) at one of six cancer centers in Washington and Idaho. Respondent ZIP code was used to assess rurality using Rural-Urban Commuting Area designation. 515 rural (43.5% of those contacted) and 146 urban (40% of those contacted) cancer patients and survivors participated. Few differences between urban and rural cancer patients and cancer survivors were noted. Rural residents were older (69.2 years vs. 66.9 years). Rural respondents had higher mean alcohol consumption than urban respondents (4.4 drinks per week vs. 2.7 drinks per week). 12.2% of those who reported drinking in the last 30 days also reported increased alcohol consumption since the start of the pandemic, with no difference in reported increased alcohol consumption in rural vs. urban respondents. 38.5% reported decreased physical activity. 20.5% reported cancelling or delaying cancer care due to the COVID-19 pandemic. Delays in cancer healthcare services and worsening health behaviors due to the COVID-19 pandemic may contribute to poorer health outcomes, with few differences between rural and urban cancer patients and cancer survivors.

COVID-19 Vaccine Response in People with Multiple Sclerosis Treated with Dimethyl Fumarate, Diroximel Fumarate, Natalizumab, Ocrelizumab, or Interferon Beta Therapy.

BACKGROUND: Some multiple sclerosis (MS) disease-modifying therapies (DMTs) impair responses to vaccines, emphasizing the importance of understanding COVID-19 vaccine immune responses in people with MS (PwMS) receiving different DMTs. METHODS: This prospective, open-label observational study enrolled 45 participants treated with natalizumab (n = 12), ocrelizumab (n = 16), fumarates (dimethyl fumarate or diroximel fumarate, n = 11), or interferon beta (n = 6); ages 18-65 years inclusive; stable on DMT for at least 6 months. Responder rates, anti-SARS-CoV-2 spike receptor-binding domain IgG (anti-RBD) geometric mean titers (GMTs), antigen-specific T cells, and vaccination-related adverse events were evaluated at baseline and 8, 24, 36, and 48 weeks after first mRNA-1273 (Moderna) dose. RESULTS: At 8 weeks post vaccination, all natalizumab-, fumarate-, and interferon beta-treated participants generated detectable anti-RBD IgG titers, compared to only 25% of the ocrelizumab cohort. At 24 and 36 weeks post vaccination, natalizumab-, fumarate-, and interferon beta-treated participants continued to demonstrate detectable anti-RBD IgG titers, whereas participants receiving ocrelizumab did not. Anti-RBD GMTs decreased 81.5% between 8 and 24 weeks post vaccination for the non-ocrelizumab-treated participants, with no significant difference between groups. At 36 weeks post vaccination, ocrelizumab-treated participants had higher proportions of spike-specific T cells compared to other treatment groups. Vaccine-associated side effects were highest in the ocrelizumab arm for most symptoms. CONCLUSIONS: These results suggest that humoral response to mRNA-1273 COVID-19 vaccine is preserved and similar in PwMS treated with natalizumab, fumarate, and interferon beta, but muted with ocrelizumab. All DMTs had preserved T cell response, including the ocrelizumab cohort, which also had a greater risk of vaccine-related side effects.

Dimethyl fumarate is associated with lower rates of infection and lower infection-related healthcare costs when compared with ocrelizumab.

BACKGROUND: 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). METHODS: 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. RESULTS: After PSM, DMF and OCR cohorts (n = 1094 in each cohort) were balanced based on baseline characteristics (standardized MD of adjusted baseline characteristics <0.1). 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], p<0.01) 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], p < 0.01) vs OCR patients, which were driven largely by infection-related hospitalization costs (-$3639 [-$6019 to -$1259], p < 0.01). CONCLUSION: DMF-treated patients PS-matched with OCR patients experienced lower annualized rates of infection encounters and lower infection-related HCCs.

Household Food Insecurity, Stress, and Anxiety among Youth and Young Adults with Diabetes

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=<0.0001) and stress (β=4.9, p=<0.0001) symptom scores compared to those with food security adjusted for covariates. Among T2D, HFI was associated with greater anxiety symptoms (β=2.8, p=0.0247) but no association was observed with stress. These findings suggest that assessing and alleviating HFI may help improve stress and anxiety among YYA with diabetes, and further study is warranted to determine associations over time.

Interferons and Multiple Sclerosis: Lessons from 25 Years of Clinical and Real-World Experience with Intramuscular Interferon Beta-1a (Avonex).

Recombinant interferon (IFN) ß-1b was approved by the US Food and Drug Administration as the first disease-modifying therapy (DMT) for multiple sclerosis (MS) in 1993. Since that time, clinical trials and real-world observational studies have demonstrated the effectiveness of IFN therapies. The pivotal intramuscular IFN ß-1a phase III trial published in 1996 was the first to demonstrate that a DMT could reduce accumulation of sustained disability in MS. Patient adherence to treatment is higher with intramuscular IFN ß-1a, given once weekly, than with subcutaneous formulations requiring multiple injections per week. Moreover, subcutaneous IFN ß-1a is associated with an increased incidence of injection-site reactions and neutralizing antibodies compared with intramuscular administration. In recent years, revisions to MS diagnostic criteria have improved clinicians' ability to identify patients with MS and have promoted the use of magnetic resonance imaging (MRI) for diagnosis and disease monitoring. MRI studies show that treatment with IFN ß-1a, relative to placebo, reduces T2 and gadolinium-enhancing lesions and gray matter atrophy. Since the approval of intramuscular IFN ß-1a, a number of high-efficacy therapies have been approved for MS, though the benefit of these high-efficacy therapies should be balanced against the increased risk of serious adverse events associated with their long-term use. For some subpopulations of patients, including pregnant women, the safety profile of IFN ß formulations may provide a particular benefit. In addition, the antiviral properties of IFNs may indicate potential therapeutic opportunities for IFN ß in reducing the risk of viral infections such as COVID-19.

Pilot Study of Telehealth Delivered Rehabilitative Exercise for Youth With Concussion: The Mobile Subthreshold Exercise Program (MSTEP).

Background: Concussion is common, and up to 30% of youth develop persistent symptoms. Preliminary data suggests treatment with rehabilitative exercise is beneficial, but most programs require frequent in-person visits, which is challenging for youth in rural areas, and has been made more difficult for all youth during the COVID-19 pandemic. We have adapted an exercise intervention to be delivered via telehealth using Zoom and personal fitness devices, which could ensure access to this type of treatment. Objective: The goal of this study was to assess feasibility and acceptability of a telehealth delivered exercise intervention for concussion, the Mobile Subthreshold Exercise Program (MSTEP), and collect pilot data regarding efficacy. Materials and Methods: All youth received the 6-week MSTEP intervention which included wearing a Fitbit and setting exercise heartrate and duration goals weekly over Zoom with the research assistant. Youth completed standardized measures of concussive symptoms (Health Behavior Inventory, HBI), fear-avoidance (Fear of Pain Questionnaire, FOPQ) and health-related quality of life (Pediatric Quality of life Assessment, PedsQL), as well as a structured qualitative exit interview. We examined change in measures over time using mixed effects modeling, controlling for age, sex, prior concussion and duration of symptoms. We coded qualitative interviews using Thematic analysis. Results: We recruited 19 subjects, 79% female with average age 14.3 (SD 2.2) and mean duration of symptoms 75.6 days (SD 33.7). Participants wore the Fitbit on 80% of days, and completed 94% of surveys and 96% of Zoom calls. Concussive symptoms (HBI) decreased significantly over the 6 week intervention (-10.6, 95%CI: -16.0 to -5.1) as did fear-avoidance (-21.6, 95%CI: -29.8 to -13.5). PedsQL improved significantly during the same time period (+15.1, 95%CI: 8.6-21.6). Approximately three-quarters (76%) of youth rated their care as "excellent." Participants appreciated the structure of the guided exercise program and the support of the RA. They also enjoyed being able to track their progress with the Fitbit. Conclusion: This study provides evidence for the feasibility and acceptability of a telehealth delivered rehabilitative exercise intervention for youth with concussion. Further research utilizing a randomized controlled trial is needed to assess efficacy. Clinical Trial Registration: https://clinicaltrials.gov, identifier: NCT03691363. https://clinicaltrials.gov/ct2/show/NCT03691363.