Conclusions And Future Directions

The use of appropriate outcome measures is critical for clinical trial success. The use of an inappropriate, nongeneralizable, or insensitive outcome measure can prevent detection of an important treatment effect. Thus, the identification of optimal outcome measures for aSAH

will increase the likelihood of identifying effective therapies in the future. Stroke investigators have identified desirable characteristics of outcome measures for use in clinical trials (12,13) . First, clinical outcome measures should be relevant to the patient, focusing on survival, disability, handicap, and QOL. Second, response variables should include items that relate to a single aspect of outcome, as a mixture of different aspects within a single scale can be confusing and difficult to interpret clinically. Third, outcome measures should be valid, reliable, and responsive to change when following patients over time. Fourth, outcome measures should be easily applied to all patients regardless of degree of injury. The use of complex neuropsychologic tests and QOL scales can be especially problematic in this regard. Finally, measures of outcome are best expressed as a single dichotomous, ordinal, or continuous variable.

In the past, most aSAH clinical trials and cohort studies have relied on global outcome scales that suffer from profound ceiling effects and are insensitive to subtle, but disabling, cognitive deficits. Much needs to be done to improve upon and standardize outcome assessment scales for aSAH. The goal should be to develop widely applicable and standardized instruments that correlate appropriately with increased disease severity, meaningful cognitive impairment, instrumental disability, handicap, and QOL.

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