Core outcome set for relapsing multiple sclerosis in adults

A wide range of therapies is available for relapsing multiple sclerosis, as well as a wide range of outcome measures and definitions, which can be explained by the absence of a core outcome set (COS) for this disease. Establishing a core outcome set is fundamental for guiding future studies as they improve the consistency and relevance of new findings and enable the results of trials to be compared and combined. These features are especially important for relapsing multiple sclerosis due to the limited number of head-to-head studies on this disease.


Principal investigator
Rosa C. Lucchetta - Post-doc in Department of Drugs and Medicines, Faculty of Pharmaceutical Sciences, São Paulo State University (UNESP), São Paulo, Brazil;

Astrid Wiens - Adjunct Professor in Federal University of Paraná, Curitiba, Brazil;

Magda L. Oliveira - Pharmacy, University Hospital of the Federal University of Grande Dourados, Dourados, Brazil
Aline de F. Bonetti - Department of Pharmacy, Federal University of Paraná, Curitiba, Brazil
Fernando Fernandez-Llimóz - Laboratory of Pharmacology, Department of Drug Sciences, Faculty of Pharmacy, University of Porto, Porto, Portugal

Further Study Information

Current Stage: Withdrawn
Date: March 2018 - December 2020
Funding source(s): None

Health Area

Disease Category: Neurology

Disease Name: Multiple sclerosis (MS), Relapsing multiple sclerosis (MS)

Target Population

Age Range: 18 - 120

Sex: Either

Nature of Intervention: Drug

Stakeholders Involved

- Clinical experts
- Researchers

Study Type

- COS for clinical trials or clinical research


- Delphi process
- Literature review

We will conduct a scoping review to explore randomized controlled trials on disease-modifying therapies for relapsing multiple sclerosis to identify and quantify the different outcome measures, instruments, and definitions of clinical efficacy, safety outcomes, health-related quality of life instruments and population subgroups. The COS will be built from the findings of the scoping review and expert opinion using the Delphi method.

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