Standard Health Outcomes Recommended for Relapsing-Remitting MS

A multidisciplinary scientific committee reported on their initiative to define a set of standard health outcomes for relapsing-remitting multiple sclerosis (RRMS) at the Americas Committee for Treatment & Research in Multiple Sclerosis (ACTRIMS) Forum 2023 in San Diego, CA. The group was motivated by potential benefits for improved healthcare quality, physician-patient interactions, and patient satisfaction as well as data harmonization among researchers.

The committee, made up of 10 representatives from various medical specialties, completed the following 4 steps as part of their initiative:

• A systematic literature review to identify relevant variables in RRMS management
• A committee meeting to select the variables to be presented to nominal groups (NG)
• Subsequent 3 NG meetings (n=29 experts) to reach a consensus on the key variables to be included in the standard set, and
• A final committee meeting to assess the final set of variables based on NG meeting results

In their final report, the committee established the following health outcome variables to evaluate during patient follow-up for RRMS:

Clinical variables:Weight, smoking habit, comorbidities, degree of disability, mobility, clinical diagnosis of secondary progressive multiple sclerosis, relapse dates, severity of relapses, recovery from relapses, MRI imaging dates, number and topography of new T2 lesions and gadolinium-enhanced lesions, degree of brain atrophy, cognitive status, visual symptoms, spasticity, bowel/bladder dysfunction, fatigue, sexual dysfunction, emotional disturbances, and sleep disorders

Treatment-related variables:Disease-modifying treatments, symptomatic treatments, comorbidity treatments, adverse events, serious adverse events, adherence, reasons for treatment discontinuation, rehabilitation, and physical activity

Variables from the impact of RRMS on the patient’s life: Health-related quality of life, pregnancy desire, work-related difficulties

Researchers also agreed to collect information on the following factors that may affect health outcomes but cannot be controlled in management of RRMS: sociodemographic factors (age, sex, race, and employment status); clinical factors (height, date of diagnosis, serological status, early symptoms, date of first episode occurrence, and the number of relapses preceding diagnosis).