(Stroke. 2001;32:1310.)
© 2001 American Heart Association, Inc.
Original Contributions |
A Modified National Institutes of Health Stroke Scale for Use in Stroke Clinical Trials
Preliminary Reliability and Validity
From the Departments of Neurology, Veterans Administration Medical Center, San Diego, and Neurosciences, University of California at San Diego School of Medicine (P.D.L.); Department of Biostatistics and Research Epidemiology, Henry Ford Health Science Center, Detroit, Mich (M.L.); Department of Neurology, Wayne State University School of Medicine, Detroit, Mich (S.R.L.); Department of Neurology, Mayo Clinic, Jacksonville, Fla (T.G.B.); and Department of Neurology, University of Cincinnati (Ohio) (J.B.).
Correspondence to Patrick D. Lyden, MD, Stroke Center (8466), 3rd Floor, OPC, Suite #3, 200 W Arbor Dr, San Diego, CA, 92103-8466. E-mail plyden{at}ucsd.edu
Background and Purpose—The National Institutes of Health Stroke Scale (NIHSS) is accepted widely for measuring acute stroke deficits in clinical trials, but it contains items that exhibit poor reliability or do not contribute meaningful information. To improve the scale for use in clinical research, we used formal clinimetric analyses to derive a modified version, the mNIHSS. We then sought to demonstrate the validity and reliability of the new mNIHSS.
Methods—The mNIHSS was derived from our prior clinimetric studies of the NIHSS by deleting poorly reproducible or redundant items (level of consciousness, face weakness, ataxia, dysarthria) and collapsing the sensory item into 2 responses. Reliability of the mNIHSS was assessed with the certification data originally collected to assess the reliability of investigators in the National Institute of Neurological Disorders and Stroke (NINDS) rtPA (recombinant tissue plasminogen activator) Stroke Trial. Validity of the mNIHSS was assessed with the outcome results of the NINDS rtPA Stroke Trial.
Results—Reliability was
improved with the mNIHSS: the number of scale items with poor 
coefficients on either of the certification tapes decreased from 8
(20%) to 3 (14%) with the mNIHSS. With the use of factor
analysis, the structure underlying the mNIHSS was found
identical to the original scale. On serial use of the scale, goodness
of fit coefficients were higher with the mNIHSS. With data from part I
of the trial data, the proportion of patients who improved 
4 points
within 24 hours after treatment was statistically significantly
increased by tPA (odds ratio, 1.3; 95% confidence limits, 1.0, 1.8;
P=0.05). Likewise, the
odds ratio for complete/nearly complete resolution of stroke symptoms 3
months after treatment was 1.7 (95% confidence limits, 1.2, 2.6) with
the mNIHSS. Other outcomes showed the same agreement when the mNIHSS
was compared with the original scale. The mNIHSS showed good
responsiveness, ie, was useful in differentiating patients likely to
hemorrhage or have a good outcome after stroke.
Conclusions—The mNIHSS appears to be identical clinimetrically to the original NIHSS when the same data are used for validation and reliability. Power appears to be greater with the mNIHSS with the use of 24-hour end points, suggesting the need for fewer patients in trials designed to detect treatment effects comparable to rtPA. The mNIHSS contains fewer items and might be simpler to use in clinical research trials. Prospective analysis of reliability and validity, with the use of an independently collected cohort, must be obtained before the mNIHSS is used in a research setting.
Editorial Comment
The NIH Stroke Scale: Is Simpler Better?
Department of Neurology and Neurosurgery, McGill University, Montreal, Quebec, Canada
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