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Updated: Dec 9, 2025

The Multiple Sclerosis Performance Test MSPT: An iPad-Based Disability Assessment Tool
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Outcome measures for disease-modifying therapies in relapsing multiple sclerosis randomized clinical trials: a

Rosa C Lucchetta1, Magda L Oliveira, Aline F Bonetti

  • 11Department of Pharmacy, Federal University of Parana, Curitiba, Brazil 2Pharmacy, University Hospital of the Federal University of Grande Dourados, Dourados, Brazil 3Laboratory of Pharmacology, Department of Drug Sciences, Faculty of Pharmacy, University of Porto, Porto, Portugal.

JBI Evidence Synthesis
|September 8, 2020
PubMed
Abstract

Insights

This review maps outcome measures for relapsing multiple sclerosis treatments. It aims to improve consistency in clinical trials by identifying and quantifying efficacy, safety, and quality of life assessments.

Area of Science:

  • Neurology
  • Clinical Trials
  • Evidence Synthesis

Background:

  • Relapsing multiple sclerosis (MS) has numerous disease-modifying therapies.
  • A lack of a core outcome set leads to varied outcome measures and definitions in MS trials.
  • This heterogeneity hinders comparison and combination of trial results, especially given limited head-to-head studies.

Purpose of the Study:

  • To systematically map and quantify outcome measures used in randomized controlled trials (RCTs) for relapsing MS.
  • To identify instruments and definitions for efficacy, safety, and health-related quality of life.
  • To explore population subgroups within these RCTs.

Main Methods:

  • Comprehensive electronic searches of major databases (PubMed, Scopus, Cochrane Library, ClinicalTrials.gov, JBI Evidence Synthesis).
  • Independent selection and data extraction by two researchers.
  • Data presentation via narrative summary, tables, and graphs.

Main Results:

  • The review will identify and quantify diverse outcome measures, instruments, and definitions.
  • It will analyze efficacy, safety outcomes, and health-related quality of life assessments.
  • Population subgroups within relapsing MS RCTs will be characterized.

Conclusions:

  • Establishing a core outcome set is crucial for enhancing consistency and comparability in relapsing MS research.
  • This mapping exercise provides a foundation for developing a standardized set of outcome measures.
  • Standardization will facilitate more robust evidence synthesis and inform clinical practice for relapsing MS.

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