International Journal of MS Care, page 1, Volume 4, Issue 4, Winter
Robert M. Herndon, MD
Robert M. Herndon is Professor of Neurology at the University of Mississippi Medical Center and Editor-in-Chief of the International Journal of MS Care.
Advances in the care and treatment of those with multiple sclerosis (MS) depend on clinical research. There has been an exponential increase in clinical research over the past few decades, driven by the development and availability of new drugs and improved tools for use in clinical trials. Most of the trials have been directed at treatment of the disease process, but increasingly, clinical trials and outcomes research studies are being conducted to improve symptom management, which can have a significant impact on the quality of life of those with MS. These are important studies and have required the development of a host of new measurement tools, some of which are well validated while others are not yet adequately validated. They vary greatly in complexity and in the time required for their completion. Measures range from counting new exacerbations to quantitative measures such as timed ambulation, nine-hole peg test, and detailed cognitive testing. Selection of the appropriate scale or measurement tool is among the most important steps in planning clinical research.
Both clinical trials and outcomes research require efficient and effective measurement tools. Selecting the appropriate tool is becoming easier as new resources become available. There are a variety of sources from which information on neurologic measurement and scales can be obtained. Sources include Measurement in Neurological Rehabilitation by Derick Wade (Oxford Univ. Press, 1992) and Handbook of Neurological Rating Scales by Robert M. Herndon (Demos Vermande [now Demos], 1997). Both of these are helpful resources that contain useful information. Unfortunately, both are now a bit out of date and do not include some of the newer measures. A new source has recently appeared online at the National MS Society Web site (http://www.nationalmssociety.org). This Web site has a listing of most of the scales used in MS research and includes the date the information on each scale was last revised. While the focus is necessarily somewhat narrower than the two books mentioned above, it is an excellent site with appropriate citations. Those interested in measuring almost any aspect of MS would do well to visit the site, which will assist them in selecting the best scale for measuring almost any MS-related function. Coverage ranges from the Kurtzke extended disability status scale and the MS Functional Composite to bladder and bowel scales and psychological tests. The individual scales are discussed in considerable detail and primary sources are provided..
It is important to use scales for the purpose(s) for which they were
designed; other purposes require adequate validation. There are excellent
discussions of types of validity in the books cited. Additional information
on designing clinical trials, including the importance of blinded patient
evaluation and details of trial planning, can be obtained from any one
of the numerous books on clinical trials, including Good Practice of Clinical
Trials by A. Spriet and T. Dupin-Spriet (Karger, 1994), Clinical Trials:
Design, Conduct and Analysis by C.L. Meinert (Oxford Univ. Press, 1986),
and several more recent books on the subject. Time spent in carefully planning
a trial is well spent as changes are difficult to make once a trial has
begun and a poorly designed trial results in a great deal of wasted effort.
© 2002 International Journal of MS Care