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THE NATURAL HISTORY OF MULTIPLE SCLEROSIS: A GEOGRAPHICALLY BASED STUDY: 4. APPLICATIONS TO PLANNING AND INTERPRETATION OF CLINICAL THERAPEUTIC TRIALS
Abstract
We used hypothetical entry criteria typical of those used in clinical therapeutic trials to determine the patients who would have been eligible among those followed in a clinic-based study of multiple sclerosis (MS) in London, Ontario, between 1972 and 1984. For these patients, we determined the observed frequency of deterioration by 1 point on the disability status scale (DSS) of Kurtzke, which is the most feasible and frequently used endpoint in clinical trials. We calculated the number of patients required for a randomized clinical trial to detect a significant result (alpha = 0.05) with 80% or 90% power based on the observed rate of deterioration. To assess the linearity of the DSS, we determined the frequency of progression and staying time at each level of the DSS. Overall the frequency of progression was lower and the staying times were longer at higher levels of disability. There was considerable intrapatient as well as interpatient variation in staying time. These data have major implications for the design and conduct of clinical therapeutic trials in MS.
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Cited by
The natural history of multiple sclerosis:a geographically based study
Cottrell, D. A., Kremenchutzky, M., Rice, G. P. A., Koopman, W. J., Hader, W., Baskerville, J., & Ebers, G. C. (1999) · Brain · doi:10.1093/brain/122.4.625 · Cited by 1,163
Self-citationHow patients with multiple sclerosis acquire disability
Lublin, F. D., Häring, D. A., Ganjgahi, H., Ocampo, A., Hatami, F., Čuklina, J., Aarden, P., Dahlke, F., Arnold, D. L., Wiendl, H., et al. (2022) · Brain · doi:10.1093/brain/awac016 · Cited by 549
Hohol, M. J., Orav, E. J., & Weiner, H. L. (1999) · Multiple Sclerosis Journal · doi:10.1177/135245859900500508 · Cited by 369
Cohen, J. A., Reingold, S. C., Polman, C. H., & Wolinsky, J. S. (2012) · The Lancet Neurology · doi:10.1016/s1474-4422(12)70059-5 · Cited by 233
Age Related Multiple Sclerosis Severity Score: Disability ranked by age
Manouchehrinia, A., Westerlind, H., Kingwell, E., Zhu, F., Carruthers, R., Ramanujam, R., Ban, M., Glaser, A., Sawcer, S., Tremlett, H., et al. (2017) · Multiple Sclerosis Journal · doi:10.1177/1352458517690618 · Cited by 174
Metadata
- Authors
- WEINSHENKER, B. G., RICE, G. P. A., NOSEWORTHY, J. H., CARRIERE, W., BASKERVILLE, J., & EBERS, G. C.
- Venue
- Brain
- Publisher
- Oxford University Press (OUP)
- Published
- 1991
- Volume
- 114
- Issue
- 2
- Pages
- 1057-1067
- ISSN
- 0006-8950 (ISSN-L)
- 1460-2156
- OpenAlex
- W1979835871
- Cited by
- 175
- References
- 0
- FWCI
- 3.47
- Type
- journal article
- Language
- en
- Open access
- closed
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- CoChat. (2026). Citation check: THE NATURAL HISTORY OF MULTIPLE SCLEROSIS: A GEOGRAPHICALLY BASED STUDY: 4. APPLICATIONS TO PLANNING AND INTERPRETATION OF CLINICAL THERAPEUTIC TRIALS. https://app.cochat.ai/papers/10.1093/brain/114.2.1057
- The paper
- WEINSHENKER, B. G., RICE, G. P. A., NOSEWORTHY, J. H., CARRIERE, W., BASKERVILLE, J., & EBERS, G. C. (1991). THE NATURAL HISTORY OF MULTIPLE SCLEROSIS: A GEOGRAPHICALLY BASED STUDY: 4. APPLICATIONS TO PLANNING AND INTERPRETATION OF CLINICAL THERAPEUTIC TRIALS. Brain. https://doi.org/10.1093/brain/114.2.1057
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
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