Acceptance Based Telephone Support around the time of Transition to Secondary Progressive Multiple Sclerosis: A Feasibility Randomised Controlled Trial

Objectives: To explore long-term effects of treatment and prognostic relevance of variables assessed at baseline and during the European secondary progressive multiple sclerosis (SPMS) trial of interferon beta 1b (IFNB-1b). Methods: We assessed 362 patients (60% female; median age 41 years; Expanded Disability Status Scale (EDSS): 5.5; 51% randomized to IFNB-1b) for their EDSS and treatment history after 10 years. Non-parametric analysis of covariance (ANCOVA) and multivariate linear regression models were applied. Results: Median EDSS was 6.0 at the end of the randomized controlled trial (RCT), in the IFNB-1b and placebo groups, and 7.0 in long-term follow-up patients (those receiving IFNB-1b in the RCT were 6.5 and those receiving placebo in the RCT were 7.0; p = 0.086). 24 patients (6.6%) were deceased. The EDSS at baseline and the EDSS change during the RCT were the most important predictors of the EDSS 10 years later (partial R2: 0.47). The ability to predict changes in EDSS 10 years after the RCT was limited ( R2: 0.12). Magnetic resonance imaging (MRI) measures remained in the predictive models, but explained < 5% of the variability. Conclusions: The results from this analysis did not provide convincing evidence to support a favorable long-term outcome in those patients allocated IFNB-1b during the RCT, in our SPMS cohort. The progressive stage of the disease remains largely unpredictable by clinical and conventional MRI measures, so better prognostic markers are needed.

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Effect of interferon-?1b on magnetic resonance imaging outcomes in secondary progressive multiple sclerosis: Results of a European multicenter, randomized, double-blind, placebo-controlled trial

Annals of Neurology ◽

10.1002/1531-8249(199912)46:6<850::aid-ana7>3.0.co;2-q ◽

1999 ◽

Vol 46 (6) ◽

pp. 850-859 ◽

Cited By ~ 104

Author(s):

D. H. Miller ◽

P. D. Molyneux ◽

G. J. Barker ◽

D. G. MacManus ◽

I. F. Moseley ◽

...

Keyword(s):

Magnetic Resonance Imaging ◽

Multiple Sclerosis ◽

Magnetic Resonance ◽

Controlled Trial ◽

Progressive Multiple Sclerosis ◽

Secondary Progressive Multiple Sclerosis ◽

Resonance Imaging ◽

Double Blind ◽

Double Blind Placebo ◽

Secondary Progressive

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Maximising Abilities, Negotiating and Generating Exercise options (MANAGE) in people with multiple sclerosis: A feasibility randomised controlled trial

Clinical Rehabilitation ◽

10.1177/02692155211064949 ◽

2021 ◽

pp. 026921552110649

Author(s):

Julie Louie ◽

Katherine Baquie ◽

Justin Offerman ◽

Catherine L. Granger ◽

Fary Khan ◽

...

Keyword(s):

Multiple Sclerosis ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Community Integration ◽

Intervention Group ◽

Alternative Methods ◽

Functional Reach ◽

Feasibility Randomised Controlled Trial ◽

High Adherence ◽

Randomised Controlled

Objective To investigate the feasibility and preliminary efficacy of a group self-management exercise and education program in people with multiple sclerosis. Design Feasibility randomised controlled trial. Setting Outpatient rehabilitation facility. Subjects Twenty-three adults (age 48.6 (11.7) years) recruited from a Multiple Sclerosis Clinic register. Interventions The intervention group undertook a 12-week group program incorporating behaviour change education, exercise and community integration. This was compared with a waitlist control group. Main measures Feasibility was measured by recruitment, adherence and safety. Efficacy outcomes included measures of physical function (6-metre and 6-min walk, Functional Reach) and self-report questionnaires (fatigue, quality of life, exercise benefits and barriers) at baseline, 6, 12 and 24 weeks. Results Of 74 individuals identified through the register, 48 (65%) were contacted and deemed eligible, and 23 (48%) agreed to participate. There was high adherence for attendance at education (57 of 72, 79%) and exercise (135 of 174, 78%) sessions. No adverse safety events occurred within the intervention sessions. Missed attendances at assessment sessions was high (5 to 8 participants missed at each time point) predominately due to health issues. The intervention group demonstrated positive changes in walking endurance, Functional Reach and fatigue, whereas the control had some reductions in walking speed and more perceived exercise barriers. Conclusions The MANAGE program appears feasible and safe for people with mild-to-moderate multiple sclerosis, with high adherence to exercise and education sessions. Future trials should consider strategies such as flexible scheduling or alternative methods of data collection to improve follow-up assessment attendance.

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Reliability of Outcome Measures in Clinical Trials in Secondary Progressive Multiple Sclerosis

Neurology ◽

10.1212/wnl.0000000000011123 ◽

2020 ◽

Vol 96 (1) ◽

pp. e111-e120 ◽

Cited By ~ 1

Author(s):

Marcus W. Koch ◽

Jop Mostert ◽

Pavle Repovic ◽

James D. Bowen ◽

Bernard Uitdehaag ◽

...

Keyword(s):

Multiple Sclerosis ◽

Outcome Measures ◽

Controlled Trial ◽

Progressive Multiple Sclerosis ◽

Secondary Progressive Multiple Sclerosis ◽

Disability Progression ◽

Secondary Progressive ◽

Randomized Controlled ◽

Disability Status ◽

Over Time

ObjectiveTo investigate the reliability of clinical outcomes in secondary progressive multiple sclerosis (SPMS) trials, we compared the frequency of progression and improvement events on different clinical outcome measures in the placebo arms of 2 large randomized controlled trial (RCT) datasets.MethodsUsing original trial data from the placebo arms of IMPACT (International MS Secondary Progressive Avonex Controlled Trial) and ASCEND (A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Participants With Secondary Progressive Multiple Sclerosis), 2 large RCTs in SPMS, we compared disability progression and similarly defined improvement with and without 3- or 6-month confirmation on the outcome measures Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test (9HPT), and their combinations.ResultsIn both datasets, the EDSS showed the highest rates of improvement over time, and the smallest difference between progression and improvement rates, followed by the T25FW and the 9HPT. For the T25FW and 9HPT, improvement rates were fairly stable over time and remained at below or around the 10% level. For the EDSS, improvement rates increased in parallel with disability progression rates.ConclusionsAll investigated outcome measures in SPMS showed some evidence of random variation and measurement error, the T25FW and 9HPT less so than the more established outcome EDSS. Our findings are relevant for the design and critical appraisal of trials in SPMS.

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