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On the analysis and interpretation of outcome measures in stroke clinical trials: lessons from the SAINT I study of NXY-059 for acute ischemic stroke Koziol JA; Feng ACStroke 2006[Oct]; 37 (10): 2644-7BACKGROUND AND PURPOSE: A variety of primary end points have been used in acute stroke trials. We focus on the modified Rankin Scale, a reliable and valid ordinal outcome measure that assesses disability on a 7-point scale. METHODS: We provide an abbreviated discussion of analytical methods for ordinal scales, and related effect size measures; we illustrate these methods and their interpretation with outcome data from the SAINT I study of NXY-059 in acute ischemic stroke. RESULTS: The nonparametric Mann-Whitney statistic provides a straightforward method for analysis of the modified Rankin Scale, and incorporates associated measures of effect size. These measures are directly related to the concepts of Number Needed to Treat and Number Needed to Harm. CONCLUSIONS: Our re-examination of the outcome data from the SAINT I study provides little evidence for the purported efficacy of NXY-059. More broadly, analysis and interpretation of ordinal outcome scales based on ascribed numerical values to the steps of the scale should be done cautiously. Statistical treatment of multiple primary outcome measures in acute stroke clinical trials should be established before analysis. Lastly, conflating statistical and clinical significance should be avoided.|*Disability Evaluation[MESH]|*Severity of Illness Index[MESH]|Acute Disease[MESH]|Benzenesulfonates/*therapeutic use[MESH]|Biomarkers[MESH]|Brain Damage, Chronic/etiology/prevention & control[MESH]|Brain Ischemia/*drug therapy[MESH]|Cardiovascular Agents/*therapeutic use[MESH]|Clinical Trials as Topic/*methods/statistics & numerical data[MESH]|Clinical Trials, Phase III as Topic/methods/statistics & numerical data[MESH]|Double-Blind Method[MESH]|Free Radical Scavengers/*therapeutic use[MESH]|Humans[MESH]|Neuroprotective Agents/*therapeutic use[MESH]|Neuropsychological Tests[MESH]|Nitrogen Oxides/*therapeutic use[MESH]|Randomized Controlled Trials as Topic/methods/statistics & numerical data[MESH]|Sample Size[MESH]|Statistics, Nonparametric[MESH]|Stroke/*drug therapy[MESH]|Treatment Failure[MESH]|Treatment Outcome[MESH] |
