and health maintenance organizations also have rehabilitation and treatment centers and unique patient registry resources. The U.S. Department of Veterans Affairs (VA) Spinal Cord Injury Service is another extensive resource with a large patient population and health care professionals with clinical expertise in rehabilitation medicine. VA, which has a number of clinics throughout the United States, has an already established infrastructure that could be used to help clinical trial administrators educate and recruit members of the community into clinical trials. Furthermore, VA has a Cooperative Studies Program to promote clinical trials throughout the VA health care system.

Standardization of Clinical Trial Outcome Measures

Currently, clinicians have more than 30 assessment tests and surveys that they can use to examine individuals with spinal cord injuries and assess their progress toward recovery (Table 6-4; see also Appendix D). Each of the individual measures in these tests and surveys focuses on a specific area of function or quality of life. However, a standard set of outcome measures is not available. This is particularly problematic in multicenter clinical trials, in which data from multiple centers must be compared to determine the efficacy of a treatment intervention. Furthermore, a single assessment scale that could provide a standardized rating of the severity of an injury and assess an individual’s progress toward recovery would be useful for researchers, clinicians, and individuals with spinal cord injuries.

One of the most frequently used scales is the American Spinal Injury Association Impairment Scale, which measures the degree of paralysis and loss of sensation (Ditunno et al., 1994). This five-point scale scores the effect of an injury on the basis of muscle strength and the severity of loss of sensory function and has been widely adopted to establish a standardized language for describing an individual’s spinal cord injury (Young, 2002) (see Chapter 2). However, the scale’s minimal resolution prevents sensitivity to small but significant changes in function (NINDS, 2003; Ellaway et al., 2004). Furthermore, the scale is focused on motor function and does not address bowel, bladder, and other functional limitations and does not assess quality of life and activities of daily living.

There is a need to develop a common set of integrated outcome measures specifically designed to assess a patients’ recovery and response to treatments and experimental therapies. The ISRT clinical initiative recommended a set of tests to ensure appropriate evaluation of the physiology of individuals with spinal cord injuries before and after treatments; however, this set has yet to be incorporated into a standard of care for all individuals with spinal cord injuries (Table 6-5). Five European spinal cord injury centers are collaborating to develop a standardized protocol for outcomes



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