The MS-LINK Outcomes Study is a prospective longitudinal multi-center observational study focused on patient-reported outcomes (PROs) collection, which aims to develop a comprehensive data source on patients with multiple sclerosis (MS).

PROs are currently underutilized and can be leveraged in conjunction with provider-reported and healthcare utilization data to improve our understanding of MS disease progression and treatment, particularly in diverse subpopulations.

The study aims to enroll ≥2000 patients from 8-10 sites in North America followed for 3 years. Patient medical history, demographics, clinical and functional outcomes, and PROs are collected digitally at baseline and subsequent regular intervals. The objective of the study is to understand PRO changes over time and to identify PRO correlations to clinical and functional outcomes in multiple sclerosis. 

As of October 2022, we report on 796 patients. Mean age of the cohort is 50, 81.7% are female, 90.5% with RRMS, and mean disease duration of 13.8 years. The study population is sociodemographically diverse with approximately 25% of patients self-reporting as non-white, and 18% self-reporting Hispanic or other ethnicity. DMT use is diverse; approximately 46% self-report no current DMT use.  Baseline mean PDDS score is 1.9 (SD = 2.1). Mean baseline PROMIS Fatigue (55.7, SD = 10.4) and Anxiety (52.5, SD = 10.1) scores are slightly elevated relative to the general population, while PROMIS Physical Function (42.6, SD = 11.4) and Cognitive Function (44.8, SD = 10.4) scores are slightly depressed. Baseline PRO completion rates of nearly 89% indicate high patient engagement.

The MS-LINK Outcomes Study uniquely utilizes a decentralized trial approach.  Use of digital dashboards provide real time tracking of outcomes and a comprehensive view of the patient experience. The diverse patient population improves the generalizability of study findings, facilitates subgroup analyses, and potential future sub-studies.