Validation of the simplified modified Rankin scale for stroke trials: Experience from the ENCHANTED alteplase-dose arm

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dc.contributor.authorChen, Xiaoying
dc.contributor.authorLi, Jingwei
dc.contributor.authorAnderson, Craig S
dc.contributor.authorLindley, Richard I
dc.contributor.authorHackett, Maree L
dc.contributor.authorRobinson, Thompson
dc.contributor.authorLavados, Pablo
dc.contributor.authorWang, Xia
dc.contributor.authorArima, Hisatomi
dc.contributor.authorChalmers, John
dc.contributor.authorDelcourt, Candice
dc.contributor.authorthe ENCHANTED Investigators
dc.date.accessioned2021-10-26T11:36:37Z
dc.date.available2021-10-26T11:36:37Z
dc.date.issued2021
dc.description.abstractBackground and aims: 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. Methods: 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. Results: 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. Conclusions: 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.es
dc.identifier.citationInternational Journal of Stroke 2021, Vol. 16(2) 222–228es
dc.identifier.urihttps://doi.org/10.1177/1747493019897858es
dc.identifier.urihttp://hdl.handle.net/11447/4923
dc.language.isoenes
dc.subjectSimplified modified Rankin scale questionnairees
dc.subjectModified Rankin scalees
dc.subjectIschemic strokees
dc.subjectClinical triales
dc.subjectHealth outcomees
dc.titleValidation of the simplified modified Rankin scale for stroke trials: Experience from the ENCHANTED alteplase-dose armes
dc.typeArticlees

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