The Tele- Exercise and Multiple Sclerosis (TEAMS) study, funded by the Patient Centered Outcome Research Institute (PCORI), is a pragmatic, cluster randomized controlled trial aimed at comparing the ...effectiveness of a 12-week complementary and alternative medicine (CAM) program for people with multiple sclerosis (MS) delivered by a therapist at a clinic and the same program initiated by the participant at home using a tablet and pre-recorded videos. The 20-session CAM program consists of yoga, Pilates and dual tasking exercises. The study aimed to enroll 820 participants with MS living in Alabama, Mississippi and Tennessee. Engagement of the stakeholder panel, clinical partners and community organizations led to interest of over 1700 people with MS across three states in the Deep South (final enrollment was n = 837). The diversity of our stakeholder groups and their extensive reach into various communities were a critical aspect for achieving our target sample size. The recruitment numbers reflect the importance of involving multiple stakeholder groups at project inception, developing relationships over time, utilizing member strengths, and monitoring their engagement on a regular basis to ensure a meaningful experience for all involved.
To report a patient with chronic recurrent multifocal osteomyelitis (CRMO) complicated by optic neuropathy and central retinal artery occlusion (CRAO).
CRMO is a noninfectious, inflammatory bone ...disorder. It is thought to be an autoimmune condition related to an imbalance of pro- and anti-inflammatory cytokines. Retinal vasculitis has been reported in a patient with CRMO but not CRAO or optic neuropathy.
We expanded the list of ophthalmic involvement of CRMO to include CRAO and optic neuropathy.
On dispose de peu de données sur l’impact du switch du rituximab à l’eculizumab (hospitalisations/comorbidités) chez les patients atteints d’une neuromyélite optique positifs aux anticorps ...anti-aquaporine 4 (NMOSD AQP4+).
Montrer l’impact du changement de traitement sur les hospitalisations, leur durée et les comorbidités chez les patients atteints de NMOSD AQP4+.
L’étude a utilisé un design avec un groupe contrôle prétest-post-test en utilisant des données des assurances maladies américaines collectées du 1/1/2015 au 3/31/2022. Deux groupes ont été constitués : un groupe switch (n=20) du rituximab vers l’eculizumab et un groupe témoin de patients sous rituximab (n=525). Cela a permis une comparaison des taux d’hospitalisations et des comorbidités (6 mois précédant et 6 mois suivant la date de référence (1 an après le début du rituximab)).
Dans le groupe de switch une réduction de 97,5 % du nombre total de jour d’hospitalisation après passage à l’eculizumab a été observée. Le nombre total de comorbidités a été significativement réduits dans le groupe switch (96 % contre 5 %). On note également une différence significative dans les distributions de survie avec hospitalisation (p=0,01) alors que dans le groupe témoin une réduction de 13 % des hospitalisations a été observée entre après versus avant la date de référence.
Dans la cohorte de patients atteints de NMOSD passant du RTX à l’ECU, il a été observé un bénéfice pour les patients grâce à une réduction significative des hospitalisations, des jours d’hospitalisation et des comorbidités. L’utilisation d’un groupe contrôle a confirmé que la majorité des bénéfices observés peuvent être associés à l’ECU et non à d’autres facteurs externes.
Ces résultats sont cohérents avec les données cliniques établis de l’ECU et indiquent que le traitement par ECU peut conduire à une réduction de l’utilisation des ressources de santé.
Treatment with natalizumab once every 4 weeks is approved for patients with relapsing-remitting multiple sclerosis, but is associated with a risk of progressive multifocal leukoencephalopathy. ...Switching to extended-interval dosing is associated with lower progressive multifocal leukoencephalopathy risk, but the efficacy of this approach is unclear. We aimed to assess the safety and efficacy of natalizumab once every 6 weeks compared with once every 4 weeks in patients with relapsing-remitting multiple sclerosis.
We did a randomised, controlled, open-label, phase 3b trial (NOVA) at 89 multiple sclerosis centres across 11 countries in the Americas, Europe, and Western Pacific. Included participants were aged 18–60 years with relapsing-remitting multiple sclerosis and had been treated with intravenous natalizumab 300 mg once every 4 weeks with no relapses for at least 12 months before randomisation, with no missed doses in the previous 3 months. Participants were randomly assigned (1:1), using a randomisation sequence generated by the study funder and contract personnel with interactive response technology, to switch to natalizumab once every 6 weeks or continue with once every 4 weeks. The centralised MRI reader, independent neurology evaluation committee, site examining neurologists, site backup examining neurologists, and site examining technicians were masked to study group assignments. The primary endpoint was the number of new or newly enlarging T2 hyperintense lesions at week 72, assessed in all participants who received at least one dose of assigned treatment and had at least one postbaseline MRI, relapse, or neurological examination or efficacy assessment. Missing primary endpoint data were handled under prespecified primary and secondary estimands: the primary estimand included all data, regardless of whether participants remained on the assigned treatment; the secondary estimand classed all data obtained after treatment discontinuation or study withdrawal as missing. Safety was assessed in all participants who received at least one dose of study treatment. Study enrolment is closed and an open-label extension study is ongoing. This study is registered with EudraCT, 2018-002145-11, and ClinicalTrials.gov, NCT03689972.
Between Dec 26, 2018, and Aug 30, 2019, 605 patients were assessed for eligibility and 499 were enrolled and assigned to receive natalizumab once every 6 weeks (n=251) or once every 4 weeks (n=248). After prespecified adjustments for missing data, mean numbers of new or newly enlarging T2 hyperintense lesions at week 72 were 0·20 (95% CI 0·07–0·63) in the once every 6 weeks group and 0·05 (0·01–0·22) in the once every 4 weeks group (mean lesion ratio 4·24 95% CI 0·86–20·85; p=0·076) under the primary estimand, and 0·31 (95% CI 0·12–0·82) and 0·06 (0·01–0·31; mean lesion ratio 4·93 95% CI 1·05–23·20; p=0·044) under the secondary estimand. Two participants in the once every 6 weeks group with extreme new or newly enlarging T2 hyperintense lesion numbers (≥25) contributed most of the excess lesions. Adverse events occurred in 194 (78%) of 250 participants in the once every 6 weeks group and 190 (77%) of 247 in the once every 4 weeks group, and serious adverse events occurred in 17 (7%) and 17 (7%), respectively. No deaths were reported. There was one case of asymptomatic progressive multifocal leukoencephalopathy (without clinical signs) in the once every 6 weeks group, and no cases in the once every 4 weeks group; 6 months after diagnosis, the participant was without increased disability and remained classified as asymptomatic.
We found a numerical difference in the mean number of new or newly enlarging T2 hyperintense lesions at week 72 between the once every 6 weeks and once every 4 weeks groups, which reached significance under the secondary estimand, but interpretation of statistical differences (or absence thereof) is limited because disease activity in the once every 4 weeks group was lower than expected. The safety profiles of natalizumab once every 6 weeks and once every 4 weeks were similar. Although this trial was not powered to assess differences in risk of progressive multifocal leukoencephalopathy, the occurrence of the (asymptomatic) case underscores the importance of monitoring and risk factor consideration in all patients receiving natalizumab.
Biogen.
Long-term exercise/rehabilitation is an integral component of the continual care for people with multiple sclerosis (MS). However, access to this care, which includes comprehensive ...exercise/rehabilitation services to people with MS, remains a significant challenge, especially in rural, low-income areas. Telerehabilitation, or what we refer to as teleexercise, can help fill service gaps for underserved MS populations in this region. This pragmatic, cluster randomized controlled effectiveness trial will compare a 12-week, 20 session complementary and alternative medicine (CAM) intervention composed of neurorehabilitative (functional) exercise, yoga and Pilates delivered at home, using pre-loaded tablets and Interactive Voice Response (IVR) system technology (TeleCAM), to the same intervention delivered in clinic by a therapist (DirectCAM). Eight hundred and twenty people with MS are being recruited across Alabama, Mississippi and Tennessee. Primary self-reported patient-centered health outcomes are: pain, fatigue, quality of life and physical activity. Secondary outcomes include four physical functioning measures: balance, endurance, gait, and strength. Each of these outcomes will be examined by age, race, sex, severity of MS and other demographics to determine if outcomes are beneficial across all groups (i.e., heterogeneity of treatment effect). The project is important to people with MS and/or caregivers because it aims to reduce their barriers to receiving exercise treatment and increases the convenience and appeal of such programs through technology.
Clinical Trials.gov Identifier: NCT03117881
Access to comprehensive exercise and rehabilitation services for people with multiple sclerosis (MS) remains a major challenge, especially in rural, low-income areas. Hence, the Tele-Exercise and ...Multiple Sclerosis (TEAMS) study aims to provide patient-centered, coordinated care by implementing a 12-week complementary and alternative medicine (CAM) intervention for adults with MS. However, due to the societal impact of coronavirus disease (COVID-19) in mid-March 2020, the University of Alabama at Birmingham announced a limited business model halting all nonessential research requiring on-site visits, which includes the TEAMS study.
In compliance with the shelter-in-place policy and quarantine guidance, a modified testing and training protocol was developed to allow participants to continue the study.
The modified protocol, which replaces on-site data collection and training procedures, includes a teleassessment package (computer tablet, blood pressure cuff, hand dynamometer, mini disc cone, measuring tape, an 8" step, and a large-print 8" × 11" paper with ruler metrics and wall-safe tape) and a virtual meeting platform for synchronous interactive training between the therapist and the participant. The teleassessment measures include resting blood pressure and heart rate, grip strength, Five Times Sit to Stand, Timed Up & Go, and the Berg Balance Scale. The teletraining component includes 20 sessions of synchronous training sessions of dual tasking, yoga, and Pilates exercises designed and customized for a range of functional levels. Teletraining lasts 12 weeks and participants are instructed to continue exercising for a posttraining period of 9 months.
The protocol modifications were supported with supplemental funding (from the Patient-Centered Outcomes Research Institute) and approved by the University Institutional Review Board for Human Use. At the time nonessential research visits were halted by the university, there were 759 people enrolled and baseline tested, accounting for 92.5% of our baseline testing completion target (N=820). Specifically, 325 participants completed the 12-week intervention and follow-up testing visits, and 289 participants needed to complete either the intervention or follow-up assessments. A modified analysis plan will include sensitivity analyses to ensure the robustness of the study results in the presence of uncertainty and protocol deviations. Study results are projected to be published in 2021.
This modified remote teleassessment/teletraining protocol will impact a large number of participants with MS who would otherwise have been discontinued from the study.
ClinicalTrials.gov NCT03117881; https://clinicaltrials.gov/ct2/show/NCT03117881.
DERR1-10.2196/18415.
More than two-thirds of students are unprepared for college-level work when they arrive at a community college and therefore are tracked into developmental classes before taking credit-bearing ...coursework Almost one-third of the community college student population consists of parents. This study aimed to find out what literacy practices parent-students engage in at home with their children to discover if any of those practices correlate with college-level literacy skills. Information on home reading practices was gathered through the use of the CECER-DLL Child and Family Questionnaire (Hammer et al., 2015), and those practices were then correlated with student ACT English and Reading subscores and end-ofsemester grades in English Composition I. The study was implemented at a rural Mississippi community college and relied on volunteers to participate since the study site does not keep records of parenthood status of students. In total, 81 participants who live with children age 15 or under at least 50% of the time responded to the survey. Descriptive statistics showed differences in the home language and literacy activities depending on age of the parent and age of the child. Correlational statistics showed positive relationships between the number of children's books in participants' homes and ACT Reading subscores. There was an especially strong positive correlation between the number of children's books and ACT Reading scores for young mothers (ages 19-25) with young children (ages 0-5). The number of children's books in the home also correlated positively with Composition I grades for African Americans and younger parents (ages 19-25). On the other hand, for white parents, there was a negative correlation between the number of children's books and Composition I grades, and for mothers, there was a negative correlation between the value placed on the home language and literacy environment (HLE) and Composition I grade. As a result of these findings, the researcher recommends further study, including a larger, more geographically diverse sample, follow-up qualitative studies, and experimental pretest-posttest studies. In addition, colleges should offer increased services to support parent-students, including providing children's books, family literacy programs, childcare, support groups, and coaching.
Background
In patients treated with dimethyl fumarate, absolute lymphocyte count decline typically occurs during the first year and then plateaus; early drops have been associated with the ...development of severe prolonged lymphopenia.
Objective
We investigated the effect of dimethyl fumarate on absolute lymphocyte counts and CD4+/CD8+ T cells in patients with relapsing–remitting multiple sclerosis treated with dimethyl fumarate in routine practice.
Methods
Lymphocyte data were collected via medical chart abstraction. Primary endpoint: change from baseline in absolute lymphocyte count and CD4+/CD8+ counts at 6‐month intervals following dimethyl fumarate initiation.
Results
Charts of 483 patients were abstracted and 476 patients included in the analysis. Mean baseline absolute lymphocyte count (2.23 × 109/l) decreased by ∼39% (95% confidence interval: –41.1 to –37.2) by month 6 and 44% (95% confidence interval: –46.6 to –42.1) by month 12. CD4+ and CD8+ T-cell subsets strongly correlated with absolute lymphocyte count, with greater decreases from baseline to 6 months vs 6–12 months, and in CD8+ vs CD4+ T cells. Prior natalizumab was not a risk factor for lymphopenia.
Conclusion
Dimethyl fumarate-associated decline in absolute lymphocyte count in the first 12 months correlated with decline in CD4+ and CD8+ T cells and was independent of prior natalizumab. Absolute lymphocyte count monitoring continues to be an effective strategy to identify patients at risk of prolonged lymphopenia.
PURPOSETo report a patient with chronic recurrent multifocal osteomyelitis (CRMO) complicated by optic neuropathy and central retinal artery occlusion (CRAO). OBSERVATIONSCRMO is a noninfectious, ...inflammatory bone disorder. It is thought to be an autoimmune condition related to an imbalance of pro- and anti-inflammatory cytokines. Retinal vasculitis has been reported in a patient with CRMO but not CRAO or optic neuropathy. CONCLUSIONSWe expanded the list of ophthalmic involvement of CRMO to include CRAO and optic neuropathy.
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