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.

中文翻译：

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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。

背景和目的 结构化、简化的改良 Rankin 量表问卷 (smRSq) 可以提高在急性卒中研究和实践中对改良 Rankin 量表 (mRS) 进行评分的询问方法的可靠性。在国际强化控制高血压和溶栓中风研究 (ENCHANTED) 的阿替普酶剂量组进行期间，我们有机会比较这些方法中的每一种以测量结果。方法 基线人口统计学数据与美国国立卫生研究院卒中量表 (NIHSS) 一起记录。在 90 天时获得的随访测量包括 mRS、smRSq 和 5 维欧洲生活质量量表 (EQ-5D)。smRSq 和 mRS 之间的一致性通过 Kappa 统计进行评估。多元逻辑回归用于确定第 90 天 smRSq 和 mRS 评分的基线预测因子。基于第 90 天 smRSq/mRS 分数的治疗效果在逻辑和有序逻辑回归模型中进行测试。结果 SmRSq 和 mRS 评分具有良好的一致性（加权 Kappa 0.79，95% 置信区间 (CI) 0.78-0.81），而年龄、房颤、糖尿病、病前 mRS（1 对 0）、基线 NIHSS 评分等变量和脑缺血的影像学迹象，同样预测了他们的分数。使用 smRSq 的死亡或残疾、顺序转移、90 天 mRS 评分的比值比为 1.05（95% CI 0.91-1.20；非劣效性单侧 P = 0.23）和 0.98（95% CI 0.87-1.11；P = 0.02 为非劣效性），类似于使用 mRS 的那些。结论 本研究证明了 smRSq 在大型、种族多样化的临床试验人群。smRSq 的评分显示与标准 mRS 完全一致，从而证实它是急性缺血性卒中后功能状态的可靠、有效和有用的替代测量。临床试验注册网址：http://www.clinicaltrials.gov。唯一标识符：NCT01422616。