Abstract:
BACKGROUND 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.
journal_name
Strokejournal_title
Strokeauthors
Koziol JA,Feng ACdoi
10.1161/01.STR.0000241106.81293.2bsubject
Has Abstractpub_date
2006-10-01 00:00:00pages
2644-7issue
10eissn
0039-2499issn
1524-4628pii
01.STR.0000241106.81293.2bjournal_volume
37pub_type
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