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Research summary · 11 d ago

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In a study analyzing 1,927 participants, a significant association was found between increased scores on patient-reported outcomes (MSIS-29v2 PH and MSWS-12v2) over 12 months and the risk of confirmed disability progression (EDSS 6-month CDP), showing hazard ratios of 1.20, 1.26, and 1.29 (p < 0.0001).

Tags: #MSResearch
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Source: Read original source (PMID 42784778)

This plain-English summary was written by AI from a published abstract and may contain errors. It is not medical advice. Read the original study and talk to your MS team before making decisions about treatment.

Why it matters

This research highlights how changes in patient-reported outcomes can correlate with disease progression in multiple sclerosis, informing future assessments in clinical trials.

What this does not prove

The study does not demonstrate treatment effectiveness, as it only points out associations between outcome measure changes and disability progression.

Next milestone

No next milestone was established from the available source.

Study facts

Study design: Not reported
Participants / samples: 1927 · basis not reported
Randomised: Not reported
Controlled: Not reported
Primary endpoint met: Yes
Relevant MS type: Not reported
Publication date: 2026-09-24
Evidence reviewed: Abstract only
Regulatory approval: Not reported
Research areas: Not classified

Original sources

Primary evidenceDeveloping Interim Outcome Measures for Multi-Arm Multistage Clinical Trials in Multiple Sclerosis. ↗DOI: 10.1212/wnl.0000000000218426

Supporting passages (5)

sample sizeWe analyzed 1,927 of the 2,046 available participants (mean age 54 [SD 7.2] years and 66% female).

primary endpoint metEDSS 6-month CDP risk was significantly associated with each 1-standard deviation 12-month score increase for the MSIS-29v2 PH (hazard ratio [HR] 1.20 [1.08-1.33]), MSWS-12v2 (HR 1.26 [1.13-1.40]), and composite (HR 1.29 [1.16-1.44]; all p < 0.0001).

findingsIn simulations, using the composite, n = 125/arm can detect a 50% treatment effect on mean 12-month change with power ≥90% and 200/arm with a power ≥95%.

publication datePublication date: 2026-09-24

limitationsTitle: Developing Interim Outcome Measures for Multi-Arm Multistage Clinical Trials in Multiple Sclerosis.

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