用于卒中试验的简化改良Rankin量表的验证：来自ENCHANTED阿替普酶剂量组的经验
Validation of the simplified modified Rankin scale for stroke trials: Experience from the ENCHANTED alteplase-dose arm.
作者信息
Chen Xiaoying, Li Jingwei, Anderson Craig S, Lindley Richard I, Hackett Maree L, Robinson Thompson, Lavados Pablo M, Wang Xia, Arima Hisatomi, Chalmers John, Delcourt Candice
机构信息
The 211065George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.
Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
出版信息
Int J Stroke. 2021 Feb;16(2):222-228. doi: 10.1177/1747493019897858. Epub 2020 Jan 22.
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.
背景与目的
在急性卒中研究与实践中，结构化、简化的改良Rankin量表问卷（smRSq）在对改良Rankin量表（mRS）评分时，相较于询问式方法，可能会提高可靠性。在开展国际强化高血压控制与溶栓卒中研究（ENCHANTED）的阿替普酶剂量组研究期间，我们有机会比较这两种结局测量方法。
方法
记录基线人口统计学数据以及美国国立卫生研究院卒中量表（NIHSS）。在90天时获得的随访指标包括mRS、smRSq和5维度欧洲生活质量量表（EQ - 5D）。使用Kappa统计量评估smRSq与mRS之间的一致性。采用多因素逻辑回归确定90天smRSq和mRS评分的基线预测因素。基于90天smRSq/mRS评分的治疗效果在逻辑回归和有序逻辑回归模型中进行检验。
结果
SmRSq和mRS评分具有良好的一致性（加权Kappa值为0.79，95%置信区间（CI）为0.78 - 0.81），而年龄、心房颤动、糖尿病、病前mRS（1 vs. 0）、基线NIHSS评分以及脑缺血的影像学征象等变量同样可预测它们的评分。使用smRSq得出的90天mRS评分中，死亡或残疾的比值比以及有序移位分别为1.05（95% CI 0.91 - 1.20；非劣效性检验单侧P = 0.23）和0.98（95% CI 0.87 - 1.11；非劣效性检验P = 0.02），与使用mRS时相似。
结论
本研究证明了smRSq在一个种族多样化的大型临床试验人群中的实用性。SmRSq评分与标准mRS显示出足够的一致性，从而证实它是急性缺血性卒中后功能状态的一种可靠、有效且有用的替代测量方法。
Zotero 插件