Validation of the simplified modified Rankin scale for stroke trials: Experience from the ENCHANTED alteplase-dose arm
Journal
International Journal of Stroke
ISSN
1747-4930
1747-4949
Date Issued
2020
Author(s)
Xiaoying Chen
Jingwei Li
Craig S Anderson
Richard I Lindley
Maree L Hackett
Thompson Robinson
Pablo M Lavados
Xia Wang
Hisatomi Arima
John Chalmers
Candice Delcourt
Type
Resource Types::text::journal::journal article
URL Institutional Repository
Abstract
<jats:sec><jats:title>Background and aims</jats:title><jats:p> The structured, simplified modified Rankin scale questionnaire (smRSq) may increase reliability over the interrogative approach to scoring the modified Rankin scale (mRS) in acute stroke research and practice. During the conduct of the alteplase-dose arm of the international ENhanced Control of Hypertension ANd Thrombolysis StrokE stuDy (ENCHANTED), we had an opportunity to compare each of these approaches to outcome measurement. </jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p> Baseline demographic data were recorded together with the National Institutes of Health Stroke Scale (NIHSS). Follow-up measures obtained at 90 days included mRS, smRSq, and the 5-Dimension European Quality of life scale (EQ-5D). Agreements between smRSq and mRS were assessed with the Kappa statistic. Multiple logistic regression was used to identify baseline predictors of Day 90 smRSq and mRS scores. Treatment effects, based on Day 90 smRSq/mRS scores, were tested in logistic and ordinal logistic regression models. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> SmRSq and mRS scores had good agreement (weighted Kappa 0.79, 95% confidence interval (CI) 0.78–0.81), while variables of age, atrial fibrillation, diabetes mellitus, pre-morbid mRS (1 vs. 0), baseline NIHSS scores, and imaging signs of cerebral ischemia, similarly predicted their scores. Odds ratios for death or disability, and ordinal shift, 90-day mRS scores using smRSq were 1.05 (95% CI 0.91–1.20; one-sided P = 0.23 for non-inferiority) and 0.98 (95% CI 0.87–1.11; P = 0.02 for non-inferiority), similar to those using mRS. </jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p> This study demonstrates the utility of the smRSq in a large, ethnically diverse clinical trial population. Scoring of the smRSq shows adequate agreement with the standard mRS, thus confirming it is a reliable, valid, and useful alternative measure of functional status after acute ischemic stroke. </jats:p></jats:sec><jats:sec><jats:title>Clinical Trial registration</jats:title><jats:p> URL: http://www.clinicaltrials.gov . Unique identifier: NCT01422616. </jats:p></jats:sec>
Cite this document
Chen, X., Li, J., Anderson, C. S., Lindley, R. I., Hackett, M. L., Robinson, T., Lavados, P. M., Wang, X., Arima, H., Chalmers, J., Delcourt, C., & for the ENCHANTED Investigators. (2021). Validation of the simplified modified Rankin scale for stroke trials: Experience from the ENCHANTED alteplase-dose arm. International Journal of Stroke, 16(2), 222-228. https://doi.org/10.1177/1747493019897858
Subjects
simplified modified rankin scale questionnaire
;
modified rankin scale
;
ischemic stroke
;
clinical trial
;
health outcome
;
brain ischemia
;
humans
;
quality of life
;
reproducibility of results
;
stroke
;
tissue plasminogen activator
;
treatment outcome
;
alteplase
;
tissue plasminogen activator
;
adult
;
aged
;
article
;
atrial fibrillation
;
brain ischemia
;
cerebrovascular accident
;
clinical effectiveness
;
controlled study
;
demography
;
diabetes mellitus
;
disability
;
dose response
;
drug dose comparison
;
drug efficacy
;
european quality of life 5 dimensions questionnaire
;
female
;
follow up
;
functional status
;
human
;
major clinical study
;
male
;
multicenter study
;
national institutes of health stroke scale
;
priority journal
;
quality of life
;
randomized controlled trial
;
rankin scale
;
treatment outcome
;
treatment planning
;
validation study
;
brain ischemia
;
reproducibility