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标准卒中结局测量指标在多大程度上反映了生活质量?临床试验数据的回顾性分析。

How well do standard stroke outcome measures reflect quality of life? A retrospective analysis of clinical trial data.

机构信息

From the Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, United Kingdom (M.A., M.B.); and Institute of Cardiovascular and Medical Sciences, University of Glasgow, Western Infirmary, United Kingdom (M.A., R.F., T.Q.).

出版信息

Stroke. 2013 Nov;44(11):3161-5. doi: 10.1161/STROKEAHA.113.001126. Epub 2013 Sep 19.

Abstract

BACKGROUND AND PURPOSE

Quality of life (QoL) is important to stroke survivors yet is often recorded as a secondary measure in acute stroke randomized controlled trials. We examined whether commonly used stroke outcome measures captured aspects of QoL.

METHODS

We examined primary outcomes by National Institutes of Health Stroke Scale (NIHSS), Barthel Index (BI) and modified Rankin Scale (mRS), and QoL by Stroke Impact Scale (SIS) and European Quality of Life Scale (EQ-5D) from the Virtual International Stroke Trials Archive (VISTA). Using Spearman correlations and logistic regression, we described the relationships between QoL mRS, NIHSS, and BI at 3 months, stratified by respondent (patient or proxy). Using χ2 analyses, we examined the mismatch between good primary outcome (mRS ≤1, NIHSS ≤5, or BI ≥95) but poor QoL, and poor primary outcome (mRS ≥3, NIHSS ≥20, or BI ≤60) but good QoL.

RESULTS

Patient-assessed QoL had a stronger association with mRS (EQ-5D weighted score n=2987, P<0.0001, r=-0.7, r2=0.53; SIS recovery n=2970, P<0.0001, r=-0.71, r2=0.52). Proxy responses had a stronger association with BI (EQ-5D weighted score n=837, P<0.0001, r=0.78, r2=0.63; SIS recovery n=867, P<0.0001, r=0.68, r2=0.48). mRS explained more of the variation in QoL (EQ-5D weighted score=53%, recovery by SIS v3.0=52%) than NIHSS or BI and resulted in fewer mismatches between good primary outcome and poor QoL (P<0.0001, EQ-5D weighted score=8.5%; SIS recovery=10%; SIS-16=4.4%).

CONCLUSIONS

The mRS seemed to align closely with stroke survivors' interests, capturing more information on QoL than either NIHSS or BI. This further supports its recommendation as a primary outcome measure in acute stroke randomized controlled trials.

摘要

背景与目的

生活质量(QoL)对脑卒中幸存者很重要,但在急性脑卒中随机对照试验中通常被记录为次要指标。我们研究了常用的脑卒中结局测量方法是否能捕捉到 QoL 的各个方面。

方法

我们从虚拟国际脑卒中试验档案(VISTA)中检查了 NIH 脑卒中量表(NIHSS)、巴氏指数(BI)和改良 Rankin 量表(mRS)的主要结局,以及脑卒中影响量表(SIS)和欧洲生命质量量表(EQ-5D)的 QoL。使用 Spearman 相关和逻辑回归,我们描述了 3 个月时患者或代理评估的 QoL mRS、NIHSS 和 BI 之间的关系。使用 χ2 分析,我们检查了主要结局良好(mRS≤1、NIHSS≤5 或 BI≥95)但 QoL 较差,以及主要结局较差(mRS≥3、NIHSS≥20 或 BI≤60)但 QoL 较好的情况之间的不匹配。

结果

患者评估的 QoL 与 mRS 具有更强的相关性(EQ-5D 加权评分 n=2987,P<0.0001,r=-0.7,r2=0.53;SIS 恢复 n=2970,P<0.0001,r=-0.71,r2=0.52)。代理反应与 BI 具有更强的相关性(EQ-5D 加权评分 n=837,P<0.0001,r=0.78,r2=0.63;SIS 恢复 n=867,P<0.0001,r=0.68,r2=0.48)。mRS 比 NIHSS 或 BI 能更好地解释 QoL 的变化(EQ-5D 加权评分=53%,SIS v3.0 恢复=52%),并导致主要结局良好和 QoL 较差之间的不匹配情况减少(P<0.0001,EQ-5D 加权评分=8.5%;SIS 恢复=10%;SIS-16=4.4%)。

结论

mRS 似乎与脑卒中幸存者的利益密切相关,比 NIHSS 或 BI 能更好地捕捉到 QoL 信息。这进一步支持其作为急性脑卒中随机对照试验中主要结局测量的建议。

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