Book contents
- Multiple Sclerosis Therapeutics
- Multiple Sclerosis Therapeutics
- Copyright page
- Contents
- Contributors
- Abbreviations list
- Foreword
- Preface
- Section I Introduction
- Section II Clinical trial methodology
- 6 Measures of neurological impairment and disability in multiple sclerosis
- 7 Assessment of neuropsychological function in multiple sclerosis
- 8 Health-related quality of life assessment in multiple sclerosis
- 9 Measures of acute and chronic lesions visualized by conventional magnetic resonance imaging
- 10 Measures of magnetization transfer
- 11 Measurement of CNS atrophy
- 12 Axonal pathology in patients with multiple sclerosis
- 13 Imaging of gray matter lesions in multiple sclerosis
- 14 Functional imaging in multiple sclerosis
- 15 Diffusion imaging in multiple sclerosis
- 16 The use of MRI in multiple sclerosis clinical trials
- 17 Optical coherence tomography to monitor axonal and neuronal integrity in multiple sclerosis
- 18 The process of drug development and approval in the United States, the European Union, and Asia
- 19 Selection, interpretation, and development of end-points for multiple sclerosis clinical trials
- 20 The challenge of demonstrating long-term benefit of disease-modifying therapies in multiple sclerosis
- 21 The growing need for alternative clinical trial designs for multiple sclerosis
- 22 Ethical considerations in multiple sclerosis clinical trials
- 23 Pharmacogenomics and related discovery-driven approaches in multiple sclerosis
- 24 Neutralizing antibodies directed against biologic agents to treat multiple sclerosis
- Section III Clinical trials of multiple sclerosis therapies
- Section IV Therapy in clinical practice
- Index
- Plate Section
6 - Measures of neurological impairment and disability in multiple sclerosis
from Section II - Clinical trial methodology
Published online by Cambridge University Press: 05 December 2011
Book contents
- Multiple Sclerosis Therapeutics
- Multiple Sclerosis Therapeutics
- Copyright page
- Contents
- Contributors
- Abbreviations list
- Foreword
- Preface
- Section I Introduction
- Section II Clinical trial methodology
- 6 Measures of neurological impairment and disability in multiple sclerosis
- 7 Assessment of neuropsychological function in multiple sclerosis
- 8 Health-related quality of life assessment in multiple sclerosis
- 9 Measures of acute and chronic lesions visualized by conventional magnetic resonance imaging
- 10 Measures of magnetization transfer
- 11 Measurement of CNS atrophy
- 12 Axonal pathology in patients with multiple sclerosis
- 13 Imaging of gray matter lesions in multiple sclerosis
- 14 Functional imaging in multiple sclerosis
- 15 Diffusion imaging in multiple sclerosis
- 16 The use of MRI in multiple sclerosis clinical trials
- 17 Optical coherence tomography to monitor axonal and neuronal integrity in multiple sclerosis
- 18 The process of drug development and approval in the United States, the European Union, and Asia
- 19 Selection, interpretation, and development of end-points for multiple sclerosis clinical trials
- 20 The challenge of demonstrating long-term benefit of disease-modifying therapies in multiple sclerosis
- 21 The growing need for alternative clinical trial designs for multiple sclerosis
- 22 Ethical considerations in multiple sclerosis clinical trials
- 23 Pharmacogenomics and related discovery-driven approaches in multiple sclerosis
- 24 Neutralizing antibodies directed against biologic agents to treat multiple sclerosis
- Section III Clinical trials of multiple sclerosis therapies
- Section IV Therapy in clinical practice
- Index
- Plate Section
Summary
This chapter deals with the measurement of impairment or disability for use in multiple sclerosis (MS) clinical trials from a medical model perspective, focusing on global clinical trial outcome measures. It addresses the methodological issues in measuring impairment and disability. The measures of neurological impairment and disability in MS can be grouped into four classes: biological assays, performance measures, rating scales and self-report measures. The Incapacity Status Scale and the multiple sclerosis (MS) Quality of Life Inventory are examples of such self-report measures, also called patient reported outcomes or PROs. Surrogate outcome measures have been studied in a variety of diseases and have been hoped for within the MS community. The development of the Multiple Sclerosis Functional Composite (MSFC) resulted from the analysis of a pooled data set of placebo control groups and natural history study databases.
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- Information
- Multiple Sclerosis Therapeutics , pp. 56 - 64Publisher: Cambridge University PressPrint publication year: 2011