Development of a stroke-specific quality of life scale

Background and Purpose-Clinical stroke trials are increasingly measuring pa tient-centered outcomes such as functional status and health-related qualit y of life (HRQOL). No stroke-specific HRQOL measure is currently available. This study presents the initial development of a valid, reliable, and resp onsive stroke-specific quality of life (SS-QOL) measure, for use in stroke trials. Methods-Domains and items for the SS-QOL were developed from patient interv iews, The SS-QOL, Short Form 36, Beck Depression Inventory, National Instit utes of Health Stroke Scale, and Barthel Index were administered to patient s 1 and 3 months after ischemic stroke. Items were eliminated with the use of standard psychometric criteria. Construct validity was assessed by compa ring domain scores with similar domains of established measures. Domain res ponsiveness was assessed with standardized effect sizes. Results-All 12 domains of the SS-QOL were unidimensional. In the final 49-i tem scale, all domains demonstrated excellent internal reliability (Cronbac h's alpha values for each domain greater than or equal to 0.73). Most domai ns were moderately correlated with similar domains of established outcome m easures (r(2) range, 0.3 to 0.5), Most domains were responsive to change (s tandardized effect sizes >0.4). One- and 3-month SS-QOL scores were associa ted with patients' self-report of HRQOL compared with before their stroke ( P<0.001), Conclusions-The SS-QOL measures HRQOL, its primary underlying construct, in stroke patients. Preliminary results regarding the reliability, validity, and responsiveness of the SS-QOL are encouraging. Further studies in divers e stroke populations are needed.