Design of the economic evaluation for the Interventional Management of Stroke (III) trial

Rationale Stroke is a common and costly condition where an effective early treatment may be expected to affect patients' future quality of life, the cost of acute medical treatment, and the cost of rehabilitation and any supportive care needed for their remaining lifetime. To assist in informing discussions on early adoption of potential treatments, economic analyses should accompany investigations that seek to improve outcomes for stroke patients. Aims The primary aim is to assess whether i.v./i.a. rt-PA therapy is cost-effective at 3 months compared with i.v. rt-PA, and provides cost-savings or is cost-neutral by 12 months. Design Cost-effectiveness of the two treatment arms will be measured at months 3, 6, 9, and 12. Cost-effectiveness will be calculated using 1.standard cost-effectiveness methodology (incremental cost-effectiveness ratios), and 2an econometric model to assess multiple outcome measures while controlling for multiple subject and treatment-related factors that are known to affect both outcomes and costs. Study outcomes Total cost for the initial hospitalization of treating stroke subjects randomized to either i.v./i.a. or i.v. rt-PA treatment arms will be measured, as will differences in types of resource utilization over 12 months between the two arms of the trial. Quality-of-life data (EuroQol EQ-5D) will be collected over a 12-month period and quality-adjusted life years will be used as a morbidity-adjusted measure of effectiveness. Subgroup analyses will include dichotomized NIH Stroke Scale (< 20, >= 20), country, time between onset and randomization, and i.a. devices.