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Title: Defining secondary progressive multiple sclerosis.
Authors: Lorscheider, Johannes
Buzzard, Katherine
Jokubaitis, Vilija
Spelman, Tim
Havrdova, Eva
Horakova, Dana
Trojano, Maria
Izquierdo, Guillermo
Girard, Marc
Duquette, Pierre
Prat, Alexandre
Lugaresi, Alessandra
Grand'Maison, François
Grammond, Pierre
Hupperts, Raymond
Alroughani, Raed
Sola, Patrizia
Boz, Cavit
Pucci, Eugenio
Lechner-Scott, Jeanette
Bergamaschi, Roberto
Oreja-Guevara, Celia
Iuliano, Gerardo
Van Pesch, Vincent
Granella, Franco
Ramo-Tello, Cristina
Spitaleri, Daniele
Petersen, Thor
Slee, Mark
Verheul, Freek
Ampapa, Radek
Amato, Maria Pia
McCombe, Pamela
Vucic, Steve
Sánchez Menoyo, José Luis
Cristiano, Edgardo
Barnett, Michael H
Hodgkinson, Suzanne
Olascoaga, Javier
Saladino, Maria Laura
Gray, Orla
Shaw, Cameron
Moore, Fraser
Butzkueven, Helmut
Kalincik, Tomas
MSBase Study Group
Keywords: MSBase;definition;disability;secondary progressive multiple sclerosis;study design
metadata.dc.subject.mesh: Adult
Cohort Studies
Disease Progression
Middle Aged
Multiple Sclerosis, Chronic Progressive
Severity of Illness Index
Issue Date: 7-Jul-2016
Abstract: A number of studies have been conducted with the onset of secondary progressive multiple sclerosis as an inclusion criterion or an outcome of interest. However, a standardized objective definition of secondary progressive multiple sclerosis has been lacking. The aim of this work was to evaluate the accuracy and feasibility of an objective definition for secondary progressive multiple sclerosis, to enable comparability of future research studies. Using MSBase, a large, prospectively acquired, global cohort study, we analysed the accuracy of 576 data-derived onset definitions for secondary progressive multiple sclerosis and first compared these to a consensus opinion of three neurologists. All definitions were then evaluated against 5-year disease outcomes post-assignment of secondary progressive multiple sclerosis: sustained disability, subsequent sustained progression, positive disability trajectory, and accumulation of severe disability. The five best performing definitions were further investigated for their timeliness and overall disability burden. A total of 17 356 patients were analysed. The best definition included a 3-strata progression magnitude in the absence of a relapse, confirmed after 3 months within the leading Functional System and required an Expanded Disability Status Scale step ≥4 and pyramidal score ≥2. It reached an accuracy of 87% compared to the consensus diagnosis. Seventy-eight per cent of the identified patients showed a positive disability trajectory and 70% reached significant disability after 5 years. The time until half of all patients were diagnosed was 32.6 years (95% confidence interval 32-33.6) after disease onset compared with the physicians' diagnosis at 36 (35-39) years. The identified patients experienced a greater disease burden [median annualized area under the disability-time curve 4.7 (quartiles 3.6, 6.0)] versus non-progressive patients [1.8 (1.2, 1.9)]. This objective definition of secondary progressive multiple sclerosis based on the Expanded Disability Status Scale and information about preceding relapses provides a tool for a reproducible, accurate and timely diagnosis that requires a very short confirmation period. If applied broadly, the definition has the potential to strengthen the design and improve comparability of clinical trials and observational studies in secondary progressive multiple sclerosis.
metadata.dc.identifier.doi: 10.1093/brain/aww173
Appears in Collections:Producción 2020

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