Defining reliable disability outcomes in multiple sclerosis

Tomas Kalincik; Gary Cutter; Tim Spelman; Vilija Jokubaitis; Eva Havrdova; Dana Horakova; Maria Trojano; Guillermo Izquierdo; Marc Girard; Pierre Duquette; Alexandre Prat; Alessandra Lugaresi; Francois Grand'Maison; Pierre Grammond; Raymond Hupperts; Celia Oreja-Guevara; Cavit Boz; Eugenio Pucci; Roberto Bergamaschi; Jeannette Lechner-Scott; Raed Alroughani; Vincent Van Pesch; Gerardo Iuliano; Ricardo Fernandez-Bolanos; Cristina Ramo; Murat Terzi; Mark Slee; Daniele Spitaleri; Freek Verheul; Edgardo Cristiano; Jose Luis Sanchez-Menoyo; Marcela Fiol; Orla Gray; Jose Antonio Cabrera-Gomez; Michael Barnett; Helmut Butzkueven

Journal article

Defining reliable disability outcomes in multiple sclerosis

Tomas Kalincik, Gary Cutter, Tim Spelman, Vilija Jokubaitis, Eva Havrdova, Dana Horakova, Maria Trojano, Guillermo Izquierdo, Marc Girard, Pierre Duquette, Alexandre Prat, Alessandra Lugaresi, Francois Grand'Maison, Pierre Grammond, Raymond Hupperts, Celia Oreja-Guevara, Cavit Boz, Eugenio Pucci, Roberto Bergamaschi, Jeannette Lechner-Scott Show all

BRAIN | OXFORD UNIV PRESS | Published : 2015

DOI: 10.1093/brain/awv258

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Abstract

Prevention of irreversible disability is currently the most important goal of disease modifying therapy for multiple sclerosis. The disability outcomes used in most clinical trials rely on progression of Expanded Disability Status Scale score confirmed over 3 or 6 months. However, sensitivity and stability of this metric has not been extensively evaluated. Using the global MSBase cohort study, we evaluated 48 criteria of disability progression, testing three definitions of baseline disability, two definitions of progression magnitude, two definitions of long-term irreversibility and four definitions of event confirmation period. The study outcomes comprised the rates of detected progression ..

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University of Melbourne Researchers

Timothy Spelman Author Surgery - St Vincent's Hospital

Helmut Butzkueven Author Medicine - Royal Melbourne Hospital

Tomas Kalincik Author Medicine - Royal Melbourne Hospital

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Grants

Awarded by NHMRC Early Career Fellowship

Awarded by NHMRC Practitioner Fellowship

Awarded by NHMRC

Awarded by NHMRC Centre for Research Excellence

Funding Acknowledgements

The work was supported by the NHMRC Early Career Fellowship (1071124), NHMRC Practitioner Fellowship (1080518), NHMRC Project Grants (1083539 and 1032484), NHMRC Centre for Research Excellence (Grant ID 1001216) and the MSBase Foundation. The MSBase Foundation is a not-for-profit organization that receives support from Merck Serono, Biogen, Novartis Pharma, Bayer-Schering, Sanofi-Aventis and BioCSL. The study was conducted separately and apart from the guidance of the sponsors.