Contemporary outcome measures in acute stroke research: choice of primary outcome measure.
Abstract
<h4>Background and purpose</h4>The diversity of available outcome measures for acute
stroke trials is challenging and implies that the scales may be imperfect. To assist
researchers planning trials and to aid interpretation, this article reviews and makes
recommendations on the available choices of scales. The aim is to identify an approach
that will be universally accepted and that should be included in most acute trials,
without seeking to restrict options for special circumstances.<h4>Methods</h4>The
article considers outcome measures that have been widely used or are currently advised.
It examines desirable properties for outcome measures such as validity, relevance,
responsiveness, statistical properties, availability of training, cultural and language
issues, resistance to comorbidity, as well as potential weaknesses. Tracking and agreement
among outcomes are covered.<h4>Results</h4>Typical ranges of scores for the common
scales are described, along with their statistical properties, which in turn influence
optimal analytic techniques. The timing of recovery on scores and usual practice in
trial design are considered.<h4>Conclusions</h4>The preferred outcome measure for
acute trials is the modified Rankin Scale, assessed at 3 months after stroke onset
or later. The interview should be conducted by a certified rater and should involve
both the patient and any relevant caregiver. Incremental benefits at any level of
the modified Rankin Scale may be acceptable. The modified Rankin Scale is imperfect
but should be retained in its present form for comparability with existing treatment
comparisons. No second measure should be required, but correlations with supporting
scales may be used to confirm consistency in direction of effects on other measures.
Type
Journal articlePermalink
https://hdl.handle.net/10161/22898Published Version (Please cite this version)
10.1161/strokeaha.111.641423Publication Info
Lees, Kennedy R; Bath, Philip MW; Schellinger, Peter D; Kerr, Daniel M; Fulton, Rachael;
Hacke, Werner; ... European Stroke Organization Outcomes Working Group (2012). Contemporary outcome measures in acute stroke research: choice of primary outcome
measure. Stroke, 43(4). pp. 1163-1170. 10.1161/strokeaha.111.641423. Retrieved from https://hdl.handle.net/10161/22898.This is constructed from limited available data and may be imprecise. To cite this
article, please review & use the official citation provided by the journal.
Collections
More Info
Show full item recordScholars@Duke
David Bruce Matchar
Professor of Medicine
My research relates to clinical practice improvement - from the development of clinical
policies to their implementation in real world clinical settings. Most recently my
major content focus has been cerebrovascular disease. Other major clinical areas in
which I work include the range of disabling neurological conditions, cardiovascular
disease, and cancer prevention. Notable features of my work are: (1) reliance on
analytic strategies such as meta-analysis, simulation, decision analy

Articles written by Duke faculty are made available through the campus open access policy. For more information see: Duke Open Access Policy
Rights for Collection: Scholarly Articles
Works are deposited here by their authors, and represent their research and opinions, not that of Duke University. Some materials and descriptions may include offensive content. More info