Introduction: Multiple sclerosis (MS) is an autoimmune-mediated neurodegenerative disorder. The United States Food and Drug Administration recommends using clinical outcome assessments (COAs) to measure concepts that matter to patients in clinical trials and to document the content validity of the COAs using conceptual models of patient experience. This study aimed to explore and document the patient experience of signs, symptoms, and health-related quality of life impacts of relapsing-remitting MS (RRMS) and primary progressive MS (PPMS) to inform future COA validation research.
Methods: We conducted a targeted literature review (TLR) and qualitative semi-structured interviews of patients with RRMS and PPMS in the United States of America (USA). Publications and interview transcripts were analyzed, synthesized, and inductively categorized to develop a conceptual model of patient experiences of RRMS and PPMS.
Results: Ten publications were reviewed as part of the TLR, and 16 participants (RRMS, n = 7; PPMS, n = 9) were interviewed. Most participants reported fatigue, muscle weakness, difficulty walking, sleep disturbance, and bladder issues. Many participants experienced negative emotional, physical, and social impacts due to the disease. Most participants also described needing to rest and plan/avoid activities, as well as requiring support from their family to manage their symptoms.
Conclusion: This study highlights the multidimensional burden of living with RRMS and PPMS. A provisional conceptual model was developed, harmonizing the TLR and interview findings. This conceptual model may be used to promote a better understanding of the patient experience of RRMS and PPMS and to evaluate the content validity of COAs during the development of new drug treatments.
Keywords: Clinical outcome assessments; Conceptual model; Multiple sclerosis; Patient-centered outcome research; Qualitative research.
Multiple sclerosis is a chronic disease that affects the nervous system. Patients with multiple sclerosis can experience symptoms like fatigue, muscle weakness, and difficulty walking. These symptoms can significantly impact their quality of life and daily functioning. This study aimed to understand the experiences of people with two types of multiple sclerosis: relapsing–remitting and primary progressive. This was done through a targeted review of the literature and conduct of interviews with participants with relapsing–remitting and primary progressive multiple sclerosis (n = 16) in the United States of America. Most participants experienced fatigue, muscle weakness, walking difficulties, sleep disturbance, and bladder issues. These symptoms significantly affected their physical, emotional, and social well-being. Many participants needed to rest frequently, plan their activities carefully, and rely on family support to manage their symptoms. Findings were organized into a conceptual model, which is a visual representation of the patient experiences of the symptoms and quality of life impacts of relapsing–remitting and primary progressive multiple sclerosis. This model can assist in determining which symptoms and impacts are most important to measure and can support the selection of appropriate measurements for these items in future clinical trials.
© 2026. The Author(s).