218 research outputs found
MSJ888610_supplementary_material – Supplemental material for Efficacy of alemtuzumab in relapsing-remitting MS patients who received additional courses after the initial two courses: Pooled analysis of the CARE-MS, extension, and TOPAZ studies
No full textSupplemental material, MSJ888610_supplementary_material for Efficacy of alemtuzumab in relapsing-remitting MS patients who received additional courses after the initial two courses: Pooled analysis of the CARE-MS, extension, and TOPAZ studies by Giancarlo Comi, Raed Alroughani, Aaron L Boster, Ann D Bass, Regina Berkovich, Óscar Fernández, Ho Jin Kim, Volker Limmroth, Jan Lycke, Richard AL Macdonell, Basil Sharrack, Barry A Singer, Patrick Vermersch, Heinz Wiendl, Tjalf Ziemssen, Alan Jacobs, Nadia Daizadeh, Claudio E Rodriguez and Anthony Traboulsee in Multiple Sclerosis Journal</p
sj-docx-1-dhj-10.1177_20552076221150745 - Supplemental material for Acceptability of wearable devices for measuring mobility remotely: Observations from the Mobilise-D technical validation study
No full textSupplemental material, sj-docx-1-dhj-10.1177_20552076221150745 for Acceptability of wearable devices for measuring mobility remotely: Observations from the Mobilise-D technical validation study by Alison Keogh, Lisa Alcock, Philip Brown, Ellen Buckley, Marina Brozgol, Eran Gazit, Clint Hansen, Kirsty Scott, Lars Schwickert, Clemens Becker, Jeffrey M. Hausdorff, Walter Maetzler, Lynn Rochester, Basil Sharrack, Ioannis Vogiatzis, Alison Yarnall, Claudia Mazzà and Brian Caulfield in Digital Health</p
MSJ881759_supplemental_material – Supplemental material for Efficacy of alemtuzumab over 6 years in relapsing–remitting multiple sclerosis patients who relapsed between courses 1 and 2: Post hoc analysis of the CARE-MS studies
No full textSupplemental material, MSJ881759_supplemental_material for Efficacy of alemtuzumab over 6 years in relapsing–remitting multiple sclerosis patients who relapsed between courses 1 and 2: Post hoc analysis of the CARE-MS studies by Bart Van Wijmeersch, Barry A Singer, Aaron Boster, Simon Broadley, Óscar Fernández, Mark S Freedman, Guillermo Izquierdo, Jan Lycke, Carlo Pozzilli, Basil Sharrack, Brian Steingo, Heinz Wiendl, Sibyl Wray, Tjalf Ziemssen, Luke Chung, David H Margolin, Karthinathan Thangavelu and Patrick Vermersch in Multiple Sclerosis Journal</p
Participant recruitment into a randomised controlled trial of exercise therapy for people with multiple sclerosis
No full textBackground: The success of a clinical trial is often dependant on whether recruitment targets can be met in the required time frame. Despite an increase in research into the benefits of exercise in people with multiple sclerosis (PwMS), no trial has reported detailed data on effective recruitment strategies for large-scale randomised controlled trials. The main purpose of this report is to provide a detailed outline of recruitment strategies, rates and estimated costs in the Exercise Intervention for Multiple Sclerosis (ExIMS) trial to identify best practices for future trials involving multiple sclerosis (MS) patient recruitment.
Methods: The ExIMS researchers recruited 120 PwMS to participate in a 12-week exercise intervention. Participants were randomly allocated to either exercise or usual-care control groups. Participants were sedentary, aged 18–65 years and had Expanded Disability Status Scale scores of 1.0–6.5. Recruitment strategies included attendance at MS outpatient clinics, consultant mail-out and trial awareness-raising activities.
Results: A total of 120 participants were recruited over the course of 34 months. To achieve this target, 369 potentially eligible and interested participants were identified. A total of 60 % of participants were recruited via MS clinics, 29.2 % from consultant mail-outs and 10.8 % through trial awareness. The randomisation yields were 33.2 %, 31.0 % and 68.4 % for MS clinic, consultant mail-outs and trial awareness strategies, respectively. The main reason for ineligibility was being too active (69.2 %), whilst for eligible participants the most common reason for non-participation was the need to travel to the study site (15.8 %). Recruitment via consultant mail out was the most cost-effective strategy, with MS clinics being the most time-consuming and most costly.
Conclusions: To reach recruitment targets in a timely fashion, a variety of methods were employed. Although consultant mail-outs were the most cost-effective recruitment strategy, use of this method alone would not have allowed us to obtain the predetermined number of participants in the required time period, thus leading to costly extensions of the project or failure to reach the number of participants required for sufficient statistical power. Thus, a multifaceted approach to recruitment is recommended for future trials
Exploration of the Physical Activity Guidelines for People with Multiple Sclerosis
No full textBackground
Despite the numerous benefits of exercise and the publication of the physical activity guidelines (PAG) in 2013, most people with multiple sclerosis (PWMS) remain physically inactive. Appropriately supported opportunities to engage in physical activity in the community remain scarce, so the extent to which the PAGs inform practice is unclear. The overarching aim of the thesis was to explore what helps PWMS engage in exercise in the community, using
the physical activity guidelines as a guide. To achieve this, the thesis explored the exercise experiences, preferences, and support needs of PWMS.
Methods
The research programme included four connected studies using a range of methodologies. Study 1 (Chapter 3) adopted a qualitative approach to explore the thoughts of people with high MS disability. Study 2 (chapter 4) was a mixed-methods feasibility study to explore high-intensity interval training in PWMS. Study 3 (chapter 6) was a qualitative study exploring the opinions of healthcare professionals and PWMS. Study 4 (chapter 8) was a mixed-methods evaluation of a community-based exercise intervention. Additionally, the
thesis includes a scoping review (chapter 5) and a systematic intervention development process using the behaviour change wheel (chapter 7). A pragmatic theoretical perspective underpins the research programme as findings were pursued that are applicable in practice and the
community.
Key Findings
The PAGs for PWMS lack inclusivity and provide little detail of exercise prescription and application. High-intensity exercise was safe and feasible for PWMS but with limited long-term appeal. For PWMS and some healthcare professionals, there is a need to change their perception of exercise professionals' competence in working with PWMS. Additionally, healthcare professionals state that discussing exercise with their patients is not a priority. Within the community, interventions are primarily aimed at people with mild MS. Also, PAGs and behaviour change theory are used sporadically in community interventions. Encouragingly,
a community-based intervention underpinned by BCT and structured using the PAGs was well attended by participants, improved constructs of the COM-B model, and may improve physical activity levels, fatigue, quality of life, self-efficacy, and physical function.
Conclusions
The PAGs exist to help support PWMS to exercise in the community. The deep understanding of the exercise experiences, preferences, and needs of PWMS gleaned through
this body of work suggests that the PAGs are currently ineffective, as the infrastructure is not in place for PWMS to enact the behaviour. Theory-informed community-based interventions show promise and need to be used to create an ecosystem where PWMS feel capable, and have the opportunities, and motivation to engage in exercise
sj-docx-1-tan-10.1177_17562864211057661 – Supplemental material for Subcutaneous cladribine to treat multiple sclerosis: experience in 208 patients
No full textSupplemental material, sj-docx-1-tan-10.1177_17562864211057661 for Subcutaneous cladribine to treat multiple sclerosis: experience in 208 patients by Kimberley Allen-Philbey, Stefania De Trane, Zhifeng Mao, Cesar Álvarez-González, Joela Mathews, Amy MacDougall, Andrea Stennett, Xia Zhou, Ozlem Yildiz, Ashok Adams, Lucia Bianchi, Camilla Blain, Christine Chapman, Karen Chung, Cris S Constantinescu, Catherine Dalton, Rachel A Farrell, Leonora Fisniku, Helen Ford, Bruno Gran, Jeremy Hobart, Zhaleh Khaleeli, Miriam Mattoscio, Sue Pavitt, Owen Pearson, Luca Peruzzotti-Jametti, Antonio Scalfari, Basil Sharrack, Eli Silber, Emma C Tallantyre, Stewart Webb, Benjamin P Turner, Monica Marta, Sharmilee Gnanapavan, Gunnar Juliusson, Gavin Giovannoni, David Baker and Klaus Schmierer in Therapeutic Advances in Neurological Disorders</p
sj-docx-2-tan-10.1177_17562864211057661 – Supplemental material for Subcutaneous cladribine to treat multiple sclerosis: experience in 208 patients
No full textSupplemental material, sj-docx-2-tan-10.1177_17562864211057661 for Subcutaneous cladribine to treat multiple sclerosis: experience in 208 patients by Kimberley Allen-Philbey, Stefania De Trane, Zhifeng Mao, Cesar Álvarez-González, Joela Mathews, Amy MacDougall, Andrea Stennett, Xia Zhou, Ozlem Yildiz, Ashok Adams, Lucia Bianchi, Camilla Blain, Christine Chapman, Karen Chung, Cris S Constantinescu, Catherine Dalton, Rachel A Farrell, Leonora Fisniku, Helen Ford, Bruno Gran, Jeremy Hobart, Zhaleh Khaleeli, Miriam Mattoscio, Sue Pavitt, Owen Pearson, Luca Peruzzotti-Jametti, Antonio Scalfari, Basil Sharrack, Eli Silber, Emma C Tallantyre, Stewart Webb, Benjamin P Turner, Monica Marta, Sharmilee Gnanapavan, Gunnar Juliusson, Gavin Giovannoni, David Baker and Klaus Schmierer in Therapeutic Advances in Neurological Disorders</p
Lymphocyte pharmacodynamics are not associated with autoimmunity or efficacy after alemtuzumab
No full textObjectiveTo examine the association between peripheral blood lymphocyte pharmacodynamics and autoimmune adverse events (AEs) or return of disease activity in alemtuzumab-treated patients with relapsing-remitting MS.MethodsPatients received 2 alemtuzumab courses (12 mg/d IV; 5 days at baseline, 3 days 12 months later) in the 2-year Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis studies (NCT00530348 and NCT00548405) and could then receive as-needed alemtuzumab or other disease-modifying therapy in a 4-year extension (NCT00930553). Lymphocytes were phenotyped quarterly over 2 years using fluorescence-activated cell sorting. Pharmacodynamic assessments included counts of total lymphocytes, CD3(+) T cells, CD4(+)/CD8(+) T cells (total/naive/memory/regulatory [T-reg]), and CD19(+) B cells (total/immature/mature/memory) and ratios of CD19(+) (total/immature/mature/memory) to T-reg (CD4(+)/CD8(+)) counts. Assessed autoimmune AEs included immune thrombocytopenia, nephropathies, and thyroid events. Efficacy assessments included relapses, 6-month confirmed disability worsening (CDW), and MRI disease activity.ResultsLymphocyte repopulation patterns, including ratios between distinct lymphocyte subsets (e.g., CD19(+) to T-reg cell count ratios), showed no significant differences over 2 years in patients developing/not developing autoimmune AEs, relapses, CDW, or MRI activity through 6 years following alemtuzumab. Lymphocyte kinetics were also unrelated to multiple autoimmune AEs or extreme clinical phenotypes.ConclusionsRepopulation kinetics of the evaluated peripheral lymphocyte subsets did not predict autoimmune AE occurrence or disease activity, including return of disease activity after 2 alemtuzumab courses. Further study is needed to investigate potential antigen-level markers of treatment response.This study was supported by Sanofi and Bayer HealthCare Pharmaceuticals. Prof. H. Wiendl was supported by the Deutsche Forschungsgemeinschaft (DFG) Grant CRC128 Project A09, and the Kompetenznetz Multiple Sklerose (Competence Network for Multiple Sclerosis) funded by the Federal Ministry of Education and Research (FKZ 01GI1308B 01GI0907).Wiendl, H (corresponding author), Univ Munster, Munster, Germany.
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