Published online before print January 4, 2007, doi: 10.1161/01.STR.0000255951.37434.aa
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(Stroke. 2007;38:245.)
© 2007 American Heart Association, Inc.
Advances in Stroke 2006 |
Recommendations From the STAIR V Meeting on Acute Stroke Trials, Technology and Outcomes
From the University of Massachusetts (M.F.), Worcester, Mass; Johns Hopkins (D.H.), Baltimore, Md; the University of Alabama at Birmingham (G.H.), Alabama; the University of Cincinnati (E.J.), Ohio; and the National Institutes of Health (S.W.), Bethesda, Md.
Correspondence to Marc Fisher, MD, UMASS/Memorial Healthcare, 119 Belmont St, Worcester, MA 01605-2982. E-mail fisherm@ummhc.org
Key Words: ischemia • telemedicine • therapy • stroke trials
An extract of the first 250 words of the full text is provided, because this article has no abstract. |
The STAIR meetings bring together stroke neurologists and other physicians, industry representatives and regulators to discuss issues related to the development of new stroke therapies. The first four STAIR meetings generated publications with recommendations for the preclinical evaluation of stroke therapies, phase II and phase III trial design, enhancing trial implementation and completion, novel approaches to measuring outcome and regulatory considerations.1–4 The impact of these recommendations from the prior STAIR meetings has been substantial, especially those related to preclinical assessment of purported stroke therapies.5 A fifth STAIR meeting was held on March 24 to 25, 2006 in Arlington, Virginia, and over 150 attendees discussed 3 main topics: considerations for measuring outcomes in acute stroke therapy trials, how to incorporate new technologies such as telemedicine and electronic databases into clinical trials, and how to best approach the development of multimodality approaches for acute stroke therapy. This report will summarize the discussions related to these 3 topics.
The recently reported SAINT-I trial has generated discussion regarding using the "shift analysis" to assess treatment efficacy in outcomes such as the modified Rankin Scale (mRS).6 This represented a novel approach because mRS data have previously been analyzed by dichotomization of the 7-point scale—for example, outcome of a Rankin score of 2 or less (slight or less disability) versus 3 or more (moderate handicap, severe handicap or death). It is well-known (at least among statisticians) that using such a dichotomization or categorization of data is likely to lose information—and thus make it harder to detect
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