Abstract P233: Descriptions of the Meaning of Modified Rankin Scale Outcomes in Acute Stroke Clinical Trials: Meta-Analysis and Call to Corrective Action
Background: The modified Rankin scale, a 7-level, clinician-reported, measure of global disability, is the most widely employed outcome scale in acute stroke trials. As the meaning of technical mRS scores (e.g. mRS 1, mRS 4) is not well-known among general clinicians, patients, and policy-makers, trialists sometimes apply valence (e.g. “excellent”, “good”) and health-state (e.g. “disabled”, “dependent”) terms to convey the clinical meaning of trial findings. The terms employed have not been well-delineated. Methods: Systematic meta-analysis assessing mRS descriptive terms across all large (n ≥ 100) RCTs for acute ischemic or hemorrhagic stroke reported 2000 - 2020, following PRISMA guidelines. Results: Among the 60 RCTs meeting study entry criteria, patient populations were acute ischemic stroke (AIS) in 88%, intracerebral hemorrhage in 8%, both in 3%. Among the 55 AIS trials, tested agents included: antiplatelet - 28%, endovascular thrombectomy - 20%, IV lytics - 20%, neuroprotective - 11%. The mRS was a major endpoint measure in 82% of trials (primary in 60%, secondary in 22%). Table 1 shows frequency of different valence terms (1A) and health state terms (1B) for 9 types of mRS analysis. Trials often used mutually contradictory terms for particular mRS outcomes. e.g. “good outcome” was applied to outcomes mRS 0-1 (2 trials), mRS 0-2 (2 trials), mRS 0-3 (1 trial), and ordinal mRS (3 trials); “favorable” was applied to mRS 0-1 (5 trials), mRS 0-2 (6 trials), and ordinal mRS (6 trials). Also many trials provided no meaningful descriptor (no valence descriptor in 82%, no health state descriptor in 58%). Conclusion: Across major acute stroke trials of the past 20 years, the valence and health state terms for different mRS outcomes have been often mutually contradictory or not provided at all. A standardized nomenclature for mRS outcome description would improve clinician and policy-maker understanding of trial results