Quantifying the patient´s perspective in neuromyelitis optica spectrum disorder: Psychometric properties of the SymptoMScreen questionnaire.

Autor: Meca-Lallana JE; Department of Neurology, Clinical Neuroimmunology Unit and Multiple Sclerosis CSUR, Hospital Universitario 'Virgen de la Arrixaca', IMIB-Arrixaca, Murcia, Spain., Maurino J; Medical Department, Roche Farma, Madrid, Spain., Pérez-Miralles F; Department of Neurology, Unit of Neuroimmunology, Hospital Universitari i Politècnic La Fe, Valencia, Spain., Forero L; Department of Neurology, Hospital Universitario Puerta del Mar, Cádiz, Spain., Sepúlveda M; Department of Neurology, Hospital Clínic i Provincial de Barcelona, Barcelona, Spain., Calles C; Department of Neurology, Hospital Universitari Son Espases, Palma de Mallorca, Spain., Martínez-Ginés ML; Department of Neurology, Hospital Universitario Gregorio Marañón, Madrid, Spain., González-Suárez I; Department of Neurology, Hospital Universitario Álvaro Cunqueiro, Vigo, Spain., Boyero S; Department of Neurology, Hospital Universitario Cruces, Bilbao, Spain., Romero-Pinel L; Department of Neurology, Hospital Universitari de Bellvitge, Barcelona, Spain., Sempere ÁP; Department of Neurology, Hospital General Universitario de Alicante, Alicante, Spain., Meca-Lallana V; Department of Neurology, Hospital Universitario La Princesa, Madrid, Spain., Querol L; Department of Neurology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain., Costa-Frossard L; Department of Neurology, Hospital Universitario Ramón y Cajal, Madrid, Spain., Prefasi D; Medical Department, Roche Farma, Madrid, Spain., Gómez-Ballesteros R; Medical Department, Roche Farma, Madrid, Spain., Ballesteros J; Department of Neurosciences and CIBERSAM, University of Basque Country (UPV/EHU), Leioa, Spain.; Biocruces Bizkaia Health Research Institute, Barakaldo, Spain.
Jazyk: angličtina
Zdroj: PloS one [PLoS One] 2021 Jul 29; Vol. 16 (7), pp. e0255317. Date of Electronic Publication: 2021 Jul 29 (Print Publication: 2021).
DOI: 10.1371/journal.pone.0255317
Abstrakt: Background: The assessment of self-reported outcomes in neuromyelitis optica spectrum disorder (NMOSD) is limited by the lack of validated disease-specific measures. The SymptoMScreen (SyMS) is a patient-reported questionnaire for measuring symptom severity in different domains affected by multiple sclerosis (MS), but has not been thoroughly evaluated in NMOSD. The aim of this study was to assess the psychometric properties of the SyMS in a sample of patients with NMOSD.
Methods: A non-interventional, cross-sectional study in adult subjects with NMOSD (Wingerchuk 2015 criteria) was conducted at 13 neuroimmunology clinics applying the SyMS. A non-parametric item response theory procedure, Mokken analysis, was performed to assess the underlying dimensional structure and scalability of items and overall questionnaire. All analyses were performed with R (v4.0.3) using the mokken library.
Results: A total of 70 patients were studied (mean age: 47.5 ± 15 years, 80% female, mean Expanded Disability Status Scale score: 3.0 [interquartile range 1.5, 4.5]). Symptom severity was low (median SyMS score: 19.0 [interquartile range 10.0, 32.0]). The SyMS showed a robust internal reliability (Cronbach's alpha: 0.90 [95% confidence interval 0.86, 0.93]) and behaved as a unidimensional scale with all items showing scalability coefficients > 0.30. The overall SyMS scalability was 0.45 conforming to a medium scale according to Mokken's criteria. Fatigue and body pain were the domains with the highest scalability coefficients. The SyMS was associated with disability (rho: 0.586), and physical and psychological quality of life (rho: 0.856 and 0.696, respectively).
Conclusions: The SyMS shows appropriate psychometric characteristics and may constitute a valuable and easy-to-implement option to measure symptom severity in patients with NMOSD.
Competing Interests: This study was funded by the Medical Department of Roche Farma Spain (ML41397). This does not alter our adherence to PLOS ONE policies on sharing data and materials. Jorge Maurino and Rocío Gómez-Ballesteros are employees of Roche Farma Spain. Daniel Prefasi was an employee of Roche Farma Spain when the study was designed, the data were collected, and the statistical analysis was carried out. Francisco Pérez-Miralles received compensation for serving on scientific advisory boards or speaking honoraria from Almirall, Biogen, Genzyme, Merck, Mylan, Novartis, Roche, Sanofi, and Teva. María Sepúlveda reports personal fees from Roche and UCB, and travel reimbursement from Sanofi and Zambon. Carmen Calles reports personal fees from Biogen, Sanofi, Merck, Novartis, Teva, and Roche. Lucía Romero-Pinel received compensation to participate in advisory boards, collaborations as a consultant and scientific communications and received research support, funding for travel and congress expenses from Biogen, Bayer, Almirall, Merck, Sanofi, Roche, Novartis, and Teva. Ángel P Sempere reports personal fees from Biogen, Roche, Merck, Sanofi, and Teva. Luis Querol reports grants from ISCIII, CIBERER, GBS-CIDP Foundation International, personal fees from UCB Pharma as the global principal investigator in clinical trial, grants and/or personal fees from Grifols, Roche, Merck, Akcea, Biogen, Novartis, Sanofi, and Annexon. Lucienne Costa-Frossard reports personal fees from Almirall, Bayer, Biogen, Biopass, BMS, Ipsen, Merck, Novartis, Sanofi, Roche, and Teva. Javier Ballesteros collaborated in this study through a research contract between the UPV/EHU and Roche Farma Spain. The authors report no other conflicts of interest in this work.
Databáze: MEDLINE
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