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Background: Tobacco-related illnesses are among the leading preventable causes of death for Latinos/as in the United States. Latino/a groups are less likely to receive advice to quit from health professionals or use tobacco cessation strategies. The position of community health workers (CHWs) warrants further attention to address tobacco-related disparities in Latino/a communities. The objective of this study was to describe CHWs' roles to inform future smoking cessation training to ensure relevance and accessibility. Methods: A needs assessment survey, including a 10-item tobacco knowledge questionnaire, was conducted with 29 Latino/a CHWs serving Latino/a communities in a metropolitan area to assess their roles, tobacco related services, attitudes, and knowledge. Results: All CHWs were Spanish-speaking and mainly employed part time (55%) in community organizations (67%). They offered various services, primarily health education. Most of the CHWs (58.6%) assessed and discussed tobacco use, yet half (51.7%) reported low confidence in this area. Some CHWs (41%) expressed that their clients/patients would use evidence-based nicotine replacement therapies as a smoking cessation treatment if offered and identified "Financial Cost" (31%) as a deterrent of use. CHWs' score on a tobacco knowledge questionnaire indicated low knowledge in areas related to tobacco (4.03 out of 10; SD = 1.92). Conclusions: CHWs reported low tobacco related knowledge and confidence, and would benefit from tailored tobacco cessation training to decrease tobacco cessation disparities. [ABSTRACT FROM AUTHOR]

Background: Ofatumumab, the first fully human anti-CD20 monoclonal antibody, is approved in several countries for relapsing multiple sclerosis (RMS). Objective: To demonstrate the bioequivalence of ofatumumab administered by an autoinjector versus a pre-filled syringe (PFS) and to explore the effect of ofatumumab on B-cell depletion. Methods: APLIOS (NCT03560739) is a 12-week, open-label, parallel-group, phase-2 study in patients with RMS receiving subcutaneous ofatumumab 20 mg every 4 weeks (q4w) (from Week 4, after initial doses on Days 1, 7, and 14). Patients were randomized 10:10:1:1 to autoinjector or PFS in the abdomen, or autoinjector or PFS in the thigh, respectively. Bioequivalence was determined by area under the curve (AUC τ ) and maximum plasma concentration (C max) for Weeks 8–12. B-cell depletion and safety/tolerability were assessed. Results: A total of 256 patients contributed to the bioequivalence analyses (autoinjector-abdomen, n = 128; PFS-abdomen, n = 128). Abdominal ofatumumab pharmacokinetic exposure was bioequivalent for autoinjector and PFS (geometric mean AUC τ , 487.7 vs 474.1 h × µg/mL (ratio 1.03); C max, 1.409 vs 1.409 µg/mL (ratio 1.00)). B-cell counts (median cells/µL) depleted rapidly in all groups from 214.0 (baseline) to 2.0 (Day 14). Ofatumumab was well tolerated. Conclusion: Ofatumumab 20 mg q4w self-administered subcutaneously via autoinjector is bioequivalent to PFS administration and provides rapid B-cell depletion. [ABSTRACT FROM AUTHOR]

Introduction: Lockdowns due to the COVID-19 pandemic radically changed nursing education. Along with social isolation, the transition to distance education affected the well-being of students in several countries, particularly Portugal and Spain. Objectives: To identify which variables are predictors of psychological well-being for Portuguese and Spanish nursing students during mandatory lockdowns. Methods: A multicenter, cross-sectional, descriptive, correlational study involving a sample of 1075 students (944 women, mean age 22.46 + /−4.95 years). Data were collected from an online questionnaire which applied the following scales: Perceived Stress Scale (α =.820); Brief COPE-14 Subscales (α =.430 < 0.930); Well-being Manifestations Measure Scale (α =.940); Herth Hope Index (α =.850). A multiple regression model was created to predict the psychological well-being of nursing students. Results: The following predictor variables were identified in the model of the psychological well-being of students during the COVID-19 pandemic: perceived stress (β =.405; p ≤.001); hope (β =.404; p ≤.001); and the mechanisms of active coping (β =.405; p ≤.001), planning (β =.097; p ≤.001), and positive reinterpretation (β =.053; p =.12). These five variables predicted 62.0% of the nursing students' psychological well-being (R 2 =.620; F = 350.82; p ≤.001). Conclusion: Promoting students' mental health is essential, especially in periods of great adversity, such as a pandemic. Our results lead the way for the design and validation of an intervention program that addresses the five variables identified as predictors of students' psychological well-being. [ABSTRACT FROM AUTHOR]

Background: Recombinant human immunoglobulin M22 (rHIgM22) has promoted remyelination in animal models and was well tolerated in people with clinically stable multiple sclerosis. Objective: Safety/tolerability of a single rHIgM22 dose was investigated following an acute relapse and to determine whether this enhanced CNS/CSF concentrations. Methods: Adults (N = 27) with acute relapse were assigned to rHIgM22 (0.5 or 2.0 mg/kg) or placebo. Study included screening/steroid administration periods and 10 study visits over 6 months. rHIgM22 CSF concentrations were assessed on days 2 and 29. Pharmacokinetic and safety samples were taken for up to 60 days. Assessments included adverse events and other clinical measures. Brain magnetic resonance imaging was performed with/without gadolinium. Results: rHIgM22 CSF levels were consistent with dose-dependent concentration on both days 2 and 29. Infusion was generally well tolerated during an acute relapse. Immunogenicity was mild. Most adverse events did not appear to be dose dependent, were mild/moderate, and were events often associated with multiple sclerosis. Conclusion: Although limited by high variability and small sample size, the data suggest enhanced CNS uptake associated with a drop in CSF levels. This study demonstrated safety of an antibody directed to myelin and oligodendrocytes in the course of active demyelinating disease. Further research into rHIgM22 is warranted. ClinicalTrials.gov : NCT02398461 https://clinicaltrials.gov/ct2/show/NCT02398461 [ABSTRACT FROM AUTHOR]

Background: Ocrelizumab and rituximab are frequently used treatments for multiple sclerosis (MS). Data on switching from rituximab to ocrelizumab is limited. Objectives: To assess the frequency, severity, and factors of infusion related reactions (IRRs) in patients with MS who switch from rituximab to ocrelizumab, compared to those who stay on rituximab. Methods: Prospective study on MS patients aged 18–65, on rituximab for at least 2 cycles, who either switched to ocrelizumab (switch group) or stayed on rituximab (comparator group) (n = 100 each). Participants were followed for IRRs, safety, and tolerability over 12 months. Results: The proportion of IRRs in patients who continue on rituximab (14%) were similar to those who switched to ocrelizumab on Day 1 (14%; p = 1.000) and Week 24 (12%; p = 0.647) but higher than at Day 15 (4%; 0.005). The risk of IRRs for the switch group was associated with the presence of B cells (CD19 and/or CD20 counts ≥1%) increasing by 5.01 (1.49, 16.82) times on Day 1 (p = 0.007). Antidrug antibodies to ocrelizumab were not associated with IRRs. No other safety concerns were identified in switching to ocrelizumab. Conclusion: IRRs are similar between both groups, which suggests that it is safe to switch from rituximab to ocrelizumab. [ABSTRACT FROM AUTHOR]

Background: Patient-reported outcome (PRO) measures have been shown to be effective for tracking treatment outcomes in multiple sclerosis (MS). However, collecting PROs as part of the clinical standard of care can be time-consuming and examination of their validity for use in an MS sample has been limited. Objective: To determine the discriminant validity of the Quality of Life in Neurological Disorders (Neuro-QoL™) short forms in a real-world MS clinic population. Design/methods: Neuro-QoL is a series of questionnaires for tracking physical function, emotional/cognitive health, and social abilities in clinical populations. Neuro-QoL data from 902 MS patients were analyzed for psychometric properties and factor structure. Results: Neuro-QoL demonstrated acceptable reliability in the moderate-to-good ranges. Moderate support for convergent validity was observed with other measures of MS quality of life, disease severity, and symptoms. However, results from a confirmatory factor analysis suggested poor model fit for most of the 12 domains tested. Conclusions: These findings support the utility of some of the Neuro-QoL questionnaires in evaluating MS-related PROs. However, additional research may help abridge and strengthen these measures for use in this population. [ABSTRACT FROM AUTHOR]

Background. Patients facing a high-stakes clinical decision are often confronted with an overwhelming array of options. High-quality decisions about treatment should reflect patients’ preferences as well as their clinical characteristics. Preference-assessment instruments typically focus on pre-selected clinical outcomes and attributes chosen by the investigator. Objective. We sought to develop a patient-centered approach to elicit and compare the treatment goals of patients with multiple sclerosis (MS) and healthcare providers (HCPs). Methods. We conducted five nominal group technique (NGT) meetings to elicit and prioritize treatment goals from patients and HCPs. Five to nine participants in each group responded silently to one question about their treatment goals. Responses were shared, consolidated, and ranked to develop a prioritized list for each group. The ranked lists were combined. Goals were rated and sorted into categories. Multidimensional scaling and hierarchical cluster analysis were used to derive a visual representation, or cognitive map, of the data and to identify conceptual clusters, reflecting how frequently items were sorted into the same category. Results. Five NGT groups yielded 34 unique patient-generated treatment goals and 31 unique HCP-generated goals. There were differences between patients and HCPs in the goals generated and how they were clustered. Patients’ goals tended to focus on the impact of specific symptoms on their day-to-day lives, whereas providers’ goals focused on slowing down the course of disease progression. Conclusions. Differences between the treatment goals of patients and HCPs underscore the limitations of using HCP- or investigator-identified goals. This new adaptation of cognitive mapping is a patient-centered approach that can be used to generate and organize the outcomes and attributes for values clarification exercises while minimizing investigator bias and maximizing relevance to patients. [ABSTRACT FROM AUTHOR]

Emerging evidence underlines the importance of micro(mi)RNAs in the pathogenesis of multiple sclerosis (MS). Free-circulating miRNAs were investigated in serum from MS patients compared to controls. Statistically significant decreased levels of miR-15b, miR-23a and miR-223 were observed in MS patients (p < 0.05). Results were validated and replicated in two further independent MS populations. A direct correlation between miRNA levels and the EDSS score was determined in PPMS (p < 0.007). The generalized trend toward miRNA down-regulation could result in over-expression of target genes involved in disease pathogenesis. Circulating miRNA profiling could thus represent a new avenue to identify easily detectable disease biomarkers. [ABSTRACT FROM PUBLISHER]

CXCL13, a B-cell chemokine, has been proposed as a biomarker in a variety of conditions, some of which can mimic multiple sclerosis and can have very high levels. In this case-control study, cerebrospinal fluid (CSF) CXCL13 was elevated in multiple sclerosis, neuromyelitis optica and other inflammatory neurological controls compared with noninflammatory controls. Levels did not differentiate disease groups. For all subjects taken together, CSF CXCL13 correlated with CSF WBC, oligoclonal band numbers, CSF protein, EDSS, and neurofilament levels. In subgroup analyses, CSF CXCL13 correlated with CSF WBC in neuromyelitis optica and IgG index in multiple sclerosis. Additionally, serum CXCL13 was elevated in neuromyelitis optica. [ABSTRACT FROM PUBLISHER]

The article presents arguments supporting the need for randomized clinical trials for testing disease-modifying therapies (DMTs) for treating multiple sclerosis (MS) in pregnant women. It talks about topics including DMT guidance for managing MS in women who wish to conceive, the impact of DMTs on breastfeeding, and testing the safety of DMTs to pregnant women and fetuses.

Objective Brain atrophy has been correlated with objective cognitive dysfunction in multiple sclerosis but few studies have explored self-reported subjective cognitive concerns and their relationship to brain volume changes. This study explores the relationship between subjective cognitive concerns in multiple sclerosis and reduced brain volume in regions of interest implicated in cognitive dysfunction. Methods A total of 158 patients with multiple sclerosis completed the Quality of Life in Neurologic Disorders Measures (Neuro-QoL) short forms to assess subjective cognitive concerns and underwent brain magnetic resonance imaging. Regional brain volumes from regions of interest implicated in cognitive dysfunction were measured using NeuroQuant automated volumetric quantitation. Linear regression was used to analyze the relationship between subjective cognitive concerns and brain volume. Results Controlling for age, disease duration, gender, depression and fatigue, increased subjective cognitive concerns were associated with reduced thalamic volume (standardized β = 0.223, t150 =2.406, P = 0.017) and reduced cortical gray matter volume (standardized β = 0.240, t150 = 2.777, P = 0.006). Increased subjective cognitive concerns were not associated with any other regions of interest that were analyzed. Conclusions Subjective cognitive concern in MS is associated with reduced thalamic and cortical gray matter volumes, areas of the brain that have been implicated in objective cognitive impairment. These findings may lend neuroanatomical significance to subjective cognitive concerns and patient-reported outcomes as measured by Neuro-QoL. [ABSTRACT FROM AUTHOR]