Stroke, Vol 25, 1746-1751, Copyright © 1994 by American Heart Association
MA Albanese, WR Clarke, HP Adams Jr and RF Woolson
BACKGROUND AND PURPOSE: Ensuring the reliability and validity of outcome
measures used in clinical trials is essential to the success of the trial.
The Trial of Org 10172 in Acute Stroke Treatment (TOAST) is a multicenter
clinical trial that is recruiting patients with acute ischemic stroke seen
at medical centers across the United States. METHODS: This paper describes
an approach to train physicians to use three clinical measures: the
National Institutes of Health (NIH) Stroke Scale, a supplemental motor
examination, and the Glasgow Outcome Scale. The program included education,
certification, remediation when needed, monitoring, and reliability
assessment. The goal was to ensure that interrater assessments were as
equivalent to one another as possible. RESULTS: Of the first 95 clinicians
who began the certification process, 75 passed during the first evaluation.
Eighteen of the other physicians were able to complete the process after
remediation. The intraclass correlations of both the NIH Stroke Scale and
supplemental motor examination exceeded 0.95. The kappa values for the
Glasgow Outcome Scale were 0.61 and 0.62 for the first and second ratings
of the videotape, respectively. CONCLUSIONS: Our experience suggests that a
program that includes educational and certification processes can be
performed as part of the design of a multicenter clinical trial. The method
of providing educational and testing videotapes to each site so that
physicians can be trained and certified is an effective, inexpensive, and
practical approach for enhancing and certifying the expertise of the large
number of physicians involved in a multicenter study.
ARTICLES
Ensuring reliability of outcome measures in multicenter clinical trials of treatments for acute ischemic stroke. The program developed for the Trial of Org 10172 in Acute Stroke Treatment (TOAST)
Office of Consultation and Research in Medical Education, University of Iowa College of Medicine, Iowa City.
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