Objectives: To 1) develop a short instrument (Stroke Impact Scale-16 [SIS-16]) to assess physical function in patients with stroke at approximately 1 to 3 months poststroke using items from the composite physical domain of the Stroke Impact Scale (SIS) version 3.0, and 2) compare the SIS-16 and a commonly used disability measure, the Barthel Index (BI), in terms of their ability to discriminate disability.
Methods: A total of 621 subjects enrolled in the GAIN Americas randomized stroke trial were included in this study. Rasch analysis, which models the probability of a subject's response to an item using both subject ability and item difficulty, was used to construct the SIS-16, describe its properties, and compare its ordering and range of item difficulties to those of the BI. Box plots and analysis of variance were used to examine differences in BI and SIS-16 scores across modified Rankin categories.
Results: The study sample had an average age of 68 +/- 12.4 years and 56% were men. Stroke diagnoses were classified as minor in 91 patients (NIH Stroke Scale score [NIHSS] 0 to 5), moderate in 304 (NIHSS 6 to 13), and major in 226 (NIHSS >/= 14). Twelve of the original 28 items in the SIS version 3.0 composite physical domain were eliminated to produce the SIS-16, with a minimal loss of reliability. As compared to the BI, the SIS-16 contains more difficult items that can differentiate patients with less severe limitations, and therefore has less pronounced ceiling effects. SIS-16 scores were significantly different across Rankin levels 0 to 1, 2, 3, 4, and 5, whereas BI was significantly different only across Rankin levels 0 to 2, 3, 4, and 5.
Conclusion: Compared to the BI, the SIS-16 is an excellent collection of items suitable for assessing a wide range of physical function limitations of patients with stroke at 1 to 3 months poststroke. Because of a less pronounced ceiling effect, the SIS-16 can differentiate lower levels of disability as compared to the BI.