Development and validation of a simplified Stroke–Thrombolytic Predictive Instrument

OBJECTIVES: The Stroke-Thrombolytic Predictive Instrument (Stroke-TPI) predicts the probability of good and bad outcomes with and without recombinant tissue plasminogen activator (rtPA). We sought to rebuild and externally validate a simpler Stroke-TPI to support implementation in routine clinical care. METHODS: Using the original derivation cohort of 1,983 patients from a combined database of randomized clinical trials (NINDS National Institute of Neurological Disorders and Stroke 1 and 2; ATLANTIS Alteplase Thrombolysis for Acute Noninterventional Therapy in Ischemic Stroke A and B; and ECASS European Cooperative Acute Stroke Study II), we simplified the Stroke-TPI by reducing variables and interaction terms and by exploring simpler (3- and 8-item) stroke severity scores. External validation was performed in the ECASS III trial (n = 821). RESULTS: The following 6 variables were most predictive of good outcomes: age, systolic blood pressure, diabetes, stroke severity, symptom onset to treatment time, and rtPA therapy. Treatment effect modifiers included onset to treatment time and systolic blood pressure. For the models predicting a bad outcome (modified Rankin Scale mRS score ≥5), significant variables included age, stroke severity, and serum glucose. rtPA therapy did not change the risk of a poor outcome. Compared with models using the full NIH Stroke Scale, models using the 3-item severity score showed similar discrimination and excellent calibration. External validation on ECASS III showed similar performance (C statistics 0.75 mRS score ≤1 and 0.80 mRS score ≤2). CONCLUSION: A simpler model using a 3-item stroke severity score, instead of the 15-item NIH Stroke Scale, has similar prognostic value and may be easier to use in routine care. Future studies are needed to test whether it can improve process and clinical outcomes.