Background

Relapsing-remitting multiple sclerosis (RRMS) has an uncertain prognosis. Patients´ subjective experience living the first few years after the diagnosis may impact their perception of the clinical course, well-being, and decision-making process.

Objectives

To assess the influence of the early-course of the RRMS on patients’ disease perception using a comprehensive standardized battery of patient-reported outcomes.

Methods

A multicenter, non-interventional, cross-sectional study will be conducted with patients diagnosed with RRMS (2017 McDonald criteria) and a disease duration ≤ 3 years (MS-ONSET study).

Demographic characteristics, clinical and imaging outcomes will be collected, including disability (Expanded Disability Status Scale), cognition (Symbol Digit Modalities Test), and magnetic resonance imaging findings. Additional outcomes from the patient´s perspective will be collected, including symptoms severity (SymptoMScreen), mobility (NeuroQol Upper Extremity and 12-item Multiple Sclerosis Walking Scale), health-related quality of life (29-item Multiple Sclerosis Impact Scale), fatigue (5-item Modified Fatigue Impact Scale), mood and anxiety (Hospital Anxiety and Depression Scale), cognition (5-item Perceived Deficit Questionnaire), perception of illness and stigma (Brief Illness Perception Questionnaire and Stigma Scale for Chronic Illness), coping (General Self-Efficacy Scale and Brief Cope), hopelessness (State-Trait Hopelessness Scale), experience of prognosis communication (ad-hoc questionnaire and Miller Behavioral Style Scale), and work-related difficulties and productivity (23-item Multiple Sclerosis Work Difficulties Questionnaire and Valuation of Lost Productivity). Participants will answer questions regarding the management of eight simulated MS case-scenarios based on clinical and radiological disease activity (treatment preferences). They will also complete a survey-experiment based on behavioral economics paradigms to assess risk preferences.

Results

Patient recruitment will begin in June 2020 with a planned total sample of 189 patients and 15 MS units throughout Spain.

Conclusions

The study results are expected to provide meaningful insights into the effect of patients´ perceived seriousness of MS at an early stage. A better understanding of patients´ experience may facilitate shared-decision making and foster the development of specific therapeutic planning in clinical practice.