LAUSR

Research Objectives To develop a conceptual model of spasticity in MS that integrates the experience of persons with MS (pwMS) and clinicians, in accordance with Food and Drug Administration guidance on patient-focused drug development. Design Targeted literature review of published articles (2014–2019) and input from three spasticity clinical experts (MC, FB, EFF) followed by one-time interviews with a separate group of three clinicians experienced in spasticity treatment/research and semi-structured interviews with pwMS. Patient interview data were collected until concept saturation (no new information provided on successive interviews). Iterative feedback from the three clinical experts and GW spasticity research team guided further refinements. Setting Phone interviews. Participants Three clinical experts; 3 clinicians experienced in spasticity treatment/research; 20 patients with MS ≥12 months and spasticity ≥6 months. Interventions Not applicable. Main Outcome Measures Key concepts of MS spasticity included objective manifestations; subjective patient experiences; triggers; moderators; physical, functional, emotional, and social impacts; and long-term consequences. Results Of 282 abstracts reviewed, 23 full-text articles were used to develop the draft model. The interviewed pwMS were on average 47.3 years old and had self-reported spasticity for an average 12.3 years. Spasms, pain, and stiffness were spasticity descriptors most frequently endorsed by both pwMS and the literature. Some pwMS had difficulty distinguishing spasticity from other MS symptoms (e.g., muscle weakness, tremor, numbness). Some triggers (e.g., skin lesions, constipation, stress), emotional impacts (e.g., embarrassment, frustration), and long-term consequences of spasticity (e.g., loss of employment or driving ability) were reported by pwMS but not in the recent literature. Conclusions MS Spasticity is complex, multidimensional, and heterogeneous. Clinicians and pwMS may use different descriptors. This integrated conceptual model may enhance future research and management of spasticity in pwMS. Author(s) Disclosures Francois Bethoux has a financial relationship with Adamas Pharmaceuticals, Biogen, Genentech, Greenwich Biosciences, Helius Medical, MedRhythms, Osmotica Pharmaceuticals, Qr8, and Springer Publishing. Michelle Cameron has a financial relationship with Adamas Pharmaceuticals, Greenwich Biosciences, and Helius Medical. William R. Lenderking has a financial relationship with Evidera. Erica Zaiser and Katelyn N. Cutts have a financial relationship with Evidera. Joshua R. Steinerman, Joanne Wagner, and Edelle Field-Fote have a financial relationship with Greeenwich Biosciences.