The stroke impact scale version 2.0. Evaluation of reliability, validity, and sensitivity to change.

BACKGROUND AND PURPOSE: To be useful for clinical research, an outcome measure must be feasible to administer and have sound psychometric attributes, including reliability, validity, and sensitivity to change. This study characterizes the psychometric properties of the Stroke Impact Scale (SIS) Version 2.0. METHODS: Version 2.0 of the SIS is a self-report measure that includes 64 items and assesses 8 domains (strength, hand function, ADL/IADL, mobility, communication, emotion, memory and thinking, and participation). Subjects with mild and moderate strokes completed the SIS at 1 month (n=91), at 3 months (n=80), and at 6 months after stroke (n=69). Twenty-five subjects had a replicate administration of the SIS 1 week after the 3-month or 6-month test. We evaluated internal consistency and test-retest reliability. The validity of the SIS domains was examined by comparing the SIS to existing stroke measures and by comparing differences in SIS scores across Rankin scale levels. The mixed model procedure was used to evaluate responsiveness of the SIS domain scores to change. RESULTS: Each of the 8 domains met or approached the standard of 0.9 alpha-coefficient for comparing the same patients across time. The intraclass correlation coefficients for test-retest reliability of SIS domains ranged from 0.70 to 0.92, except for the emotion domain (0.57). When the domains were compared with established outcome measures, the correlations were moderate to strong (0.44 to 0.84). The participation domain was most strongly associated with SF-36 social role function. SIS domain scores discriminated across 4 Rankin levels. SIS domains are responsive to change due to ongoing recovery. Responsiveness to change is affected by stroke severity and time since stroke. CONCLUSIONS: This new, stroke-specific outcome measure is reliable, valid, and sensitive to change. We are optimistic about the utility of measure. More studies are required to evaluate the SIS in larger and more heterogeneous populations and to evaluate the feasibility and validity of proxy responses for the most severely impaired patients.