title: Functional clinical outcomes in multiple sclerosis: Current status and future prospects.
abstract: For decades, the Expanded Disability Status Scale (EDSS) has been the principal measure of disability in clinical trials in patients with multiple sclerosis (MS) and in clinical practice. However, this test is dominated by effects on ambulation. Composite endpoints may provide a more sensitive measure of MS-related disability through the measurement of additional neurological functions. The MS Functional Composite (MSFC) includes a walking test (25-ft walk) plus tests of upper extremity dexterity (9-hole peg test) and cognitive function (Paced Auditory serial Addition test [PASAT]). Replacing PASAT with the Symbol Digit Modality test, a more sensitive test preferred by patients, may improve the clinical utility of the MSFC. In addition, disease-specific measures of QoL may be used alongside the MSFC (which does not include measurement of QoL). Clinical data suggest that disease-modifying therapies may delay or prevent relapse, and better composite measures will be valuable in the assessment of disease activity-free status in people with MS.
authors.affiliation: Hacettepe University Hospitals, Dept. of Neurology, Neuroimmunology Unit, Ankara, Turkey. Electronic address: rkbudak@hacettepe.edu.tr.
authors.forename: Rana
authors.initials: R
authors.lastname: Karabudak
authors.affiliation: Department of Internal Medicine, Neurology Section, Arab Medical Center and Khalidi Hospital, Amman, Jordan.
authors.forename: Maurice
authors.initials: M
authors.lastname: Dahdaleh
authors.affiliation: King Abdullah International Medical Research Center, King Saud Ben Abdulaziz University for Health Sciences, NGHA, Riyadh, Saudi Arabia; Prince Mohammed bin Abdul-Aziz Hospital, Ministry of Health, Riyadh, Saudi Arabia.
authors.forename: Mohammed
authors.initials: M
authors.lastname: Aljumah
authors.affiliation: Division of Neurology, Amiri Hospital, Kuwait; Division of Neurology, Dasman Diabetes Institute, Kuwait.
authors.forename: Raed
authors.initials: R
authors.lastname: Alroughani
authors.affiliation: Clinical Neurosciences Department, Salmaniya Medical Complex, Manama, Bahrain.
authors.forename: I Ahmed
authors.initials: IA
authors.lastname: Alsharoqi
authors.affiliation: Neurology Section, King Khalid University Hospital, King Saud University and Dallah Hospital, Saudi Arabia.
authors.forename: Abdulrahman M
authors.initials: AM
authors.lastname: AlTahan
authors.affiliation: Department of Neurosciences, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia.
authors.forename: Saeed A
authors.initials: SA
authors.lastname: Bohlega
authors.affiliation: Neurology Section, King Khalid University Hospital, King Saud University and Dallah Hospital, Saudi Arabia.
authors.forename: Abdulkader
authors.initials: A
authors.lastname: Daif
authors.affiliation: Department of Neurology (Medicine), Hamad Medical Corporation, Doha, Qatar.
authors.forename: Dirk
authors.initials: D
authors.lastname: Deleu
authors.affiliation: Merck Serono Intercontinental Region, Dubai, United Arab Emirates.
authors.forename: Amer
authors.initials: A
authors.lastname: Amous
authors.affiliation: Neurology Department, Rashid Hospital and Dubai Medical College, Dubai Health Authority, United Arab Emirates.
authors.forename: Jihad S
authors.initials: JS
authors.lastname: Inshasi
authors.affiliation: Neurologische Klinik Bamberg, Bamberg, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Rieckmann
authors.affiliation: MS Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Iran.
authors.forename: Mohammed A
authors.initials: MA
authors.lastname: Sahraian
authors.affiliation: Multiple Sclerosis Center, American University of Beirut Medical Center, Beirut, Lebanon.
authors.forename: Bassem I
authors.initials: BI
authors.lastname: Yamout
mesh_terms: D004185:Disability Evaluation; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D008297:Male; D009103:Multiple Sclerosis / Q000175:diagnosis* / Q000628:therapy; D017063:Outcome Assessment, Health Care / Q000379:methods*; D011788:Quality of Life; D016896:Treatment Outcome
keywords: Clinical outcome measures; Clinical trials; Disease-modifying therapies; Multiple sclerosis