Xiaoying Chen1,2, Jingwei Li1,3,4, Craig S Anderson1,5,6, Richard I Lindley7, Maree L Hackett1,2,8, Thompson Robinson9,10, Pablo M Lavados11,12, Xia Wang1, Hisatomi Arima1,13, John Chalmers1, Candice Delcourt1,2,6. 1. The 211065George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia. 2. Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia. 3. Department of Cardiology, People's Liberation Army General Hospital, Beijing, China. 4. Department of Cardiology, Xinqiao Hospital, Third Military Medical University, Chongqing, China. 5. The George Institute China at Peking University Health Science Center, Beijing, PR China. 6. Neurology Department, 2205Royal Prince Alfred Hospital, Sydney Health Partners, Sydney, NSW, Australia. 7. Westmead Clinical School, University of Sydney, Sydney, NSW, Australia. 8. Faculty of Health and Wellbeing, University of Central Lancashire, Lancashire, UK. 9. Department of Cardiovascular Sciences, University of Leicester, Leicester, UK. 10. NIHR Biomedical Research Centre, Leicester, UK. 11. Departamento de Ciencias Neurológicas, Facultad de Medicina, Universidad de Chile, Santiago, Chile. 12. Unidad de Neurología Vascular, Servicio de Neurología, Departamento de Neurología y Psiquiatría, Clínica Alemana de Santiago, Facultad de Medicina, Universidad del Desarrollo, Santiago, Chile. 13. Department of Preventive Medicine and Public Health, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.
Abstract
BACKGROUND 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. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01422616.
BACKGROUND 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. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01422616.
Authors: E Nobels-Janssen; E N Postma; I L Abma; J M C van Dijk; R Haeren; H Schenck; W A Moojen; M H den Hertog; D Nanda; A R E Potgieser; B A Coert; W I M Verhagen; R H M A Bartels; P J van der Wees; D Verbaan; H D Boogaarts Journal: J Neurol Date: 2021-11-08 Impact factor: 6.682