Susana Sainz de la Maza1, Rocío Gómez-Ballesteros2, Mónica Borges3, Jesús Martín-Martínez4, Javier Sotoca5, Ana Alonso6, Ana B Caminero7, Laura Borrega8, José L Sánchez-Menoyo9, Francisco J Barrero-Hernández10, Carmen Calles11, Luis Brieva12, María R Blasco-Quílez13, Julio Dotor Garcia-Soto3, María del Campo-Amigo14, Laura Navarro-Cantó15, Eduardo Agüera16, Moisés Garcés-Redondo17, Olga Carmona18, Laura Gabaldón-Torres19, Lucía Forero20, Mariona Hervás21, Jorge Maurino2, Tamara Castillo-Trivino22
1Hospital Universitario Ramón y Cajal, 2Medical Department, Roche Farma, 3Hospital Universitario Virgen Macarena, 4Hospital Universitario Miguel Servet, 5Hospital Universitari Mútua Terrassa, 6Hospital Regional Universitario de Málaga, 7Complejo Asistencial de Ávila, 8Hospital Universitario Fundación Alcorcón, 9Hospital de Galdakao-Usansolo, 10Hospital Universitario Clínico San Cecilio, 11Hospital Universitari Son Espases, 12Hospital Universitari Arnau de Vilanova, 13Hospital Universitario Puerta de Hierro, 14Complexo Hospitalario Universitario de Pontevedra, 15Hospital General Universitario de Elche, 16Hospital Universitario Reina Sofía, 17Hospital Clínico Universitario Lozano Blesa, 18Fundació Salut Empordà, 19Hospital Francesc de Borja, 20Hospital Universitario Puerta del Mar, 21Consorci Corporació Sanitària Parc Taulí, 22Hospital Universitario Donostia
Objective:
The aim of this study was to evaluate symptom severity and its correlation with different patient-reported and clinician-rated measures.
Background:
Patients with early-stage relapsing remitting multiple sclerosis (RRMS) might experience a variety of symptoms since the start of the disease. Patient-reported measures that assess multiple domains can help clinicians when assessing these symptoms, while further supporting remote disease monitoring.
Design/Methods:
A multicentre, non-interventional study was conducted. Adult patients with RRMS diagnosis, disease duration ≤3 years, and Expanded Disability Status Scale (EDSS) score between 0-5.5 were included. Multiple Sclerosis Walking Scale (MSWS-12), NeuroQoL Upper Extremity (NeuroQoL-UE), EDSS, Pain Visual Analogue Scale (VAS), Modified Fatigue Impact Scale (MFIS-5), Symbol Digit Modalities Test (SDMT), Hospital Anxiety and Depression Scale (HADS), and SymptoMScreen (SyMS) were used to assess gait, hand dexterity, spasticity, pain, fatigue, information processing speed, depression and anxiety, and symptom severity, respectively.
Outcome measures associations were analysed using bivariate linear regressions.
Results:
A total of 189 patients were included (mean age: 36.1±9.4 years, 71.4% female, mean disease duration: 1.4±0.8 years). Median EDSS score was 1.0 (IQR=0.0-2.0). A proportion of 20.3% (38/187) of patients were receiving symptomatic treatment.
Symptom severity was low with a mean (SD) overall SyMS score of 12.0 (10.8). SyMS mean score was highest for fatigue 1.6 (1.4) and lowest for bladder control 0.7 (1.1). SyMS
walking, hand function, spasticity, pain, fatigue, cognition, depression, and anxiety dimensions showed significant correlations with MSWS-12, NeuroQoL-UE, EDSS, VAS, MFIS-5, SDMT, HADS-depression, and HADS-anxiety, respectively (0.046, -0.174, 0.246, 0.022, 0.219, -0.021, 0.244, and 0.210; all p=0 but spasticity p=0.007).
Conclusions:
Patient-reported measures can enable early-stage RRMS patients to communicate symptom severity in multiple overt and less tangible key domains facilitating shared decision-making. SyMS is a short and easy-to-use questionnaire that can be useful to screen for specific symptoms referring the patient for more extensive testing when needed.