Functional clinical outcomes in multiple sclerosis: Current status and future prospects
Affiliations
Affiliations
- Hacettepe University Hospitals, Dept. of Neurology, Neuroimmunology Unit, Ankara, Turkey. Electronic address: rkbudak@hacettepe.edu.tr.
- Department of Internal Medicine, Neurology Section, Arab Medical Center and Khalidi Hospital, Amman, Jordan.
- 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.
- Division of Neurology, Amiri Hospital, Kuwait; Division of Neurology, Dasman Diabetes Institute, Kuwait.
- Clinical Neurosciences Department, Salmaniya Medical Complex, Manama, Bahrain.
- Neurology Section, King Khalid University Hospital, King Saud University and Dallah Hospital, Saudi Arabia.
- Department of Neurosciences, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia.
- Department of Neurology (Medicine), Hamad Medical Corporation, Doha, Qatar.
- Merck Serono Intercontinental Region, Dubai, United Arab Emirates.
- Neurology Department, Rashid Hospital and Dubai Medical College, Dubai Health Authority, United Arab Emirates.
- Neurologische Klinik Bamberg, Bamberg, Germany.
- MS Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Iran.
- Multiple Sclerosis Center, American University of Beirut Medical Center, Beirut, Lebanon.
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.
Keywords: Clinical outcome measures; Clinical trials; Disease-modifying therapies; Multiple sclerosis.
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References
https://pubmed.ncbi.nlm.nih.gov/