In two parallel randomized trials in patients with MS, ublituximab resulted in lower relapse rates and fewer brain lesions on MRI than teriflunomide over a period of 96 weeks but did not affect ...disability.
Background:
Ublituximab, a novel monoclonal antibody (mAb) targeting a unique epitope on the CD20 antigen, is glycoengineered for enhanced B-cell targeting through antibody-dependent cellular ...cytotoxicity (ADCC). Greater ADCC may allow lower doses and shorter infusion times versus other anti-CD20 mAbs.
Objective:
The objective was to determine optimal dose, infusion time, and activity of ublituximab in relapsing multiple sclerosis.
Methods:
This is a phase 2, placebo-controlled study. Patients received three ublituximab infusions (150 mg over 1–4 hours on day 1 and 450–600 mg over 1–3 hours on day 15 and week 24) in six dosing cohorts. The primary endpoint was B-cell depletion.
Results:
In all cohorts (N = 48), median B-cell depletion was >99% by week 4, maintained at weeks 24 and 48. Most common adverse events (AEs) were infusion-related reactions (all grade 1–2), with no apparent increased incidence at shorter infusion times. There were no AE-related discontinuations. At weeks 24 and 48, no T1 gadolinium-enhancing lesions (p = 0.003) and a 10.6% decrease in T2 lesion volume (p = 0.002) were detected. The annualized relapse rate was 0.07; 93% remained relapse free on study. Overall, 74% of patients had no evidence of disease activity (NEDA).
Conclusion:
Ublituximab was safely infused as rapid as 1 hour, producing robust B-cell depletion and profound reductions in magnetic resonance imaging (MRI) activity and relapses.
Alternative payment models were set up to increase the value of care for total joint arthroplasty. Currently, total knee arthroplasty (TKA) and total hip arthroplasty (THA) are reimbursed within the ...same bundle. We sought to determine whether it was appropriate for these cases to be included within the same bundle.
The data were collected from consecutive patients in a bundled payment program at a single large academic institution. All payments for 90 days postoperatively were included in the episode of care. Readmission rates, demographics, and length of stay were collected for each episode of care.
There was a significant difference in cost of episode of care between TKA and THA, with the average TKA episode-of-care cost being higher than the average THA episode-of-care cost ($25803 vs $23805, P < .0001). There was a statistically significant difference between the 2 groups between gender, race, medical complexity, disposition outcome, and length of stay. The TKA group trended toward a lower readmission rate (5.3%) compared to the THA group (6.6%).
The cost of an episode of care for patients within the bundled payment model is significantly higher for patients undergoing TKA compared with those undergoing a THA. This should be taken into consideration when determining payment plans for patients in alternative payment plans, along with other aspects of risk that need to be considered in order to allow for hospitals to be successful under the bundled payment model.
Pre- and post-migration stressors can put resettled refugee children at risk of poor mental health outcomes. The Family Strengthening Intervention for Refugees (FSI-R) is a peer-delivered ...preventative home visiting program for resettled refugees that aims to draw upon families' strengths to foster improved family communication, positive parenting, and caregiver-child relationships, with the ultimate goal of reducing children's risk of mental health problems. Using an explanatory sequential mixed methods design, this study draws upon qualitative interviews with caregivers (n = 19) and children (n = 17) who participated in a pilot study of the FSI-R intervention in New England, as well as interventionists (n = 4), to unpack quantitative findings on mental health and family functioning from a randomized pilot study (n = 80 families). Most patterns observed in the quantitative data as published in the pilot trial were triangulated by qualitative data. Bhutanese caregivers and children noted that children were less shy or scared to speak up after participating in the FSI-R. Somali Bantu families spoke less about child mental health and underscored feasibility challenges like language barriers between caregivers and children. Interventionists suggested that families with higher levels of education were more open to implementing behavior change. In both groups, families appreciated the intervention and found it to be feasible and acceptable, but also desired additional help in addressing broader family and community needs such as jobs and literacy programs.
Transnational migration of refugees is associated with poor mental health, particularly among children. We conducted a pilot trial of the Family Strengthening Intervention for Refugees (FSI-R), using ...a community-based participatory research (CBPR) approach to deliver a home-based intervention “for refugees by refugees” to improve family functioning and child mental health. N = 80 refugee families in the Greater Boston area participated in the study (n = 40 Somali Bantu families; n = 40 Bhutanese families) with n = 41 families randomized to care-as-usual. Of the 39 families who received FSI-R, n = 36 caregivers and children completed qualitative exit interviews. We present findings from these interviews to identify the mechanisms through which a family-strengthening intervention for refugees can be acceptable, feasible, and effective at improving family functioning and children's mental health outcomes. Authors applied Grounded Theory to code interview transcripts and detailed field notes and used an iterative process to arrive at final codes, themes, and a theoretical framework. The greatest contributors to acceptability and feasibility included flexibility in scheduling intervention sessions, the interventionist being a community member, and improvements to family communication and time spent together. All of these factors were made possible by the CBPR approach. Our findings suggest that given the socio-political context within the U.S. and the economic challenges faced by refugee families, the successful implementation of such interventions hinges on culturally-grounding the intervention design process, drawing heavily on community input, and prioritizing community members as interventionists.
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