The value of quality of life research in stroke.
The value of quality of life research in stroke.
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卒中生活质量研究的价值。
DOI：
10.1161/01.str.0000234047.57744.d9
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发表时间：
2006
期刊：
影响因子：
8.3
通讯作者：
Kissela,Brett
中科院分区：
文献类型：
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作者：
Kissela,Brett
这一期的中风包含了一篇由Williams等人撰写的优秀文章，该文章涉及结果研究的一个重要领域：健康相关的生活质量(HRQOL)。1 Williams和他的同事之前已经创建并验证了中风特定生活质量量表(SSQOL)，2该量表现在被用作许多正在进行的中风临床试验的次要结果衡量标准。在这篇文章中，他们衡量了从家庭代理人那里获得SSQOL的有效性。对于许多中风的读者来说，结果研究可能不像其他主题那样具有刺激性，例如临床试验或流行病学研究的结果。大多数拿到这个问题的人不会(或没有)立即关注威廉姆斯的文章，并首先阅读它。然而，与HRQOL等结果相关的研究越来越重要，特别是对临床试验人员来说。中风临床试验一般使用“原始的”序数量表，如改良的Rankin(MRS)来衡量中风后的功能性结果。MRS具有临床意义，因为它是中风后独立性的一种衡量标准，独立性对我们的患者来说是一个重要的结果。因此，这是一种适当的结果衡量标准，将其描述为“粗糙”并不是为了批评使用它的研究。然而，像MRS或Barthel指数这样的指标对时间的变化相对不敏感(特别是如果在分析中一分为二的话)，在给定的研究人群中可能会表现出上限或下限效应，并且可能不能很好地反映中风对患者后续生活的影响。例如，关于最后一点，在一些试验中，中风后的最佳结果被定义为0到2的MRS。NIHSS视野切断评分为2的患者可以独立生活，并被认为是MRS的最佳结果，但仍可能因其缺陷而感到严重受损，无法在以前的职业中开车或工作。让我们来看看迄今为止进行的一项主要急性卒中临床试验：NINDS tPA试验是如何衡量结果的。在这项比较成功的治疗和安慰剂的试验中，在4个相对“粗糙”的终点发现了大的效果大小，并对所有4.3个后续试验进行了综合测量。随后的试验没有安慰剂组那么奢侈，结果可能不会显示出如此强大的效果大小。以确定新的调查方法或
This issue of Stroke contains an excellent article by Williams et al that deals with an important area of outcomes research: health-related quality of life (HRQOL). 1 Williams and colleagues have previously created and validated the Stroke Specific Quality of Life scale (SSQOL), 2 which is now being used as a secondary outcome measure in many ongoing stroke clinical trials. In this article, they measure the validity of obtaining the SSQOL from a family proxy.For many among the readership of Stroke, outcomes research may not be as stimulating as other topics, such as the results of clinical trials or epidemiological studies. Most who pick up this issue will not (or did not) immediately focus on the Williams article and read it first. And yet, research with regard to outcomes such as HRQOL is of increasing importance, especially for clinical trialists. Stroke clinical trials in general have used “crude” ordinal scales such as the modified Rankin (mRS) to measure functional poststroke outcomes. The mRS is clinically meaningful in that it is a measure of poststroke independence, and independence is an important outcome for our patients. As such, it is an appropriate outcome measure and describing it as “crude” is not intended to criticize studies that have used it. However, measures like the mRS or the Barthel Index are relatively insensitive to change over time (especially if dichotomized in analysis), can exhibit ceiling or floor effects in a given study population, and may poorly represent the impact of stroke on a patient’s subsequent life. For example, with regard to the last point, in some trials an optimal poststroke outcome is defined as a mRS of 0 to 2. A patient with a NIHSS score of 2 for a visual field cut might live independently and be considered an optimal outcome on the mRS, but may still feel greatly impaired by their deficit and be unable to drive or work in their previous occupation. Let us look at how outcomes were measured in one of the major acute stroke clinical trials performed to date: the NINDS tPA trial. In this trial comparing a successful treatment to placebo, a large effect size was found across 4 relatively “crude” end points and a combined measure of all 4. 3 Subsequent trials do not have the luxury of a placebo group, and results will not likely exhibit so robust of an effect size. To determine whether new investigational methods or