CRIMSON-Considering Risks and Benefits in MS Treatment Selection
Research type
Research Study
Full title
Considering risks and benefits in multiple sclerosis treatment selection (CRIMSON)
IRAS ID
199646
Contact name
Ana Manzano
Contact email
Sponsor organisation
University of Leeds
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Disease modifying treatments (DMT) for MS are treatments to reduce the number and severity of clinical attacks (also called relapses or flares). They aim to reduce inflammation in the brain and spinal cord and thereby reduce attacks. They are taken usually over a long time and we assume are likely to be the best way to change the natural course of MS i.e. reduce relapses and minimising disability. They
do not necessarily make a person feel better; people with MS (PwMS) tend to look upon them as an investment for the future. Examples include glatiramer acetate (copaxone) and natalizumab (tysabri).
The DMT currently available can reduce disease activity and disease progression
for many individuals with relapsing remitting form of MS (RRMS). This study will establish which attributes of disease modifying treatments for relapsing remitting multiple sclerosis(RRMS) are most important to people with MS(PwMS). Objectives of the study:
1. To determine:
- the most important attributes (characteristics) of DMT to PwRRMS.
- how DMT adverse effects are communicated /understood by PwMS
2. To quantify PwMS perceptions of relative importance of adverse events/benefits of DMT with reference to efficacy/ effectiveness/ quality of life.
3. To develop an evidence-based resource to help PwRRMS with decision-making
Methods:
A qualitative study of PwRRMS will identify MS-DMT key attributes and explore how adverse events are best communicated to inform the formulation of a discrete choice experiment (DCE). >500 PwRRMS from the MS Register (stratified by disease duration, course and severity) will complete it elucidating MS-DMT preferences and trade-offs. The DCE will also identify a method for supporting people to make trade-offs, to help identify, and structure, the information included within a decision-aid
to support shared decision-making.REC name
London - City & East Research Ethics Committee
REC reference
16/LO/0536
Date of REC Opinion
18 Mar 2016
REC opinion
Favourable Opinion