Ravi Garg, Gabriel Torrealba-Acosta, Pitchaiah Mandava
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引用次数: 0
Abstract
Background: Recent American Heart Association guidelines have relied on post hoc subgroup analyses to identify summary blood pressure measures for targets in early management of acute intracerebral hemorrhage. To our knowledge, measurement error has not been considered when determining the impact of these summary measures. Our objective was to determine whether statistically significant differences in three systolic blood pressure (SBP) measures (achieved SBP, SBP variability, and magnitude of SBP reduction) in patients with intracerebral hemorrhage from the antihypertensive treatment of acute cerebral hemorrhage II (ATACH-2) randomized clinical trial are clinically meaningful by comparing them to a minimally detectable difference (MDD) of 10 mm Hg.
Methods: We performed a post hoc analysis of individual patient data from the ATACH-2 randomized clinical trial, evaluating the differences in achieved SBP, SBP variability, and magnitude of SBP reduction between patients with favorable (modified Rankin scale score 0-3) and unfavorable (modified Rankin scale score 4-6) outcomes. We used the empirical cumulative distribution functions and Kolmogorov-Smirnov tests to compare distributions, and we considered differences clinically meaningful if they exceeded the MDD of 10 mm Hg. We also performed a propensity score matched analysis to understand the nature of the association between these measures and outcomes.
Results: Although SBP variability in the first 24 h differed statistically between outcome groups, the mean difference (95% confidence interval) did not exceed the MDD threshold. Achieved SBP and magnitude of SBP reduction showed no significant differences between groups. In the propensity score matched analysis, there were no statistical differences between any blood pressure measurements and outcomes.
Conclusions: Our findings suggest that although there are statistically significant differences in SBP variability between patients with good and poor outcomes in ATACH-2, these differences do not meet the threshold for clinical relevance because they were within the range of measurement noise. The propensity score matched analysis suggested that the association between summary blood pressure measurements and outcomes is not robust to analytical method. These findings emphasize the need for caution in interpreting post hoc findings for clinical decision-making.
背景:最近的美国心脏协会指南依赖于事后亚组分析来确定急性脑出血早期治疗目标的汇总血压测量。据我们所知,在确定这些汇总测量的影响时,没有考虑测量误差。我们的目的是通过将抗高血压治疗急性脑出血II (ATACH-2)随机临床试验中脑出血患者的三项收缩压(SBP)测量(达到的收缩压、收缩压变异性和收缩压降低幅度)与10毫米hg的最小可检测差异(MDD)进行比较,确定是否具有统计学意义的差异具有临床意义。我们对来自ATACH-2随机临床试验的个体患者数据进行了事后分析,评估了有利(改良Rankin量表得分0-3)和不利(改良Rankin量表得分4-6)结果的患者在收缩压、收缩压变异性和收缩压降低幅度方面的差异。我们使用经验累积分布函数和Kolmogorov-Smirnov检验来比较分布,如果它们超过10 mm Hg的MDD,我们认为差异具有临床意义。我们还进行了倾向评分匹配分析,以了解这些测量和结果之间关联的本质。结果:虽然前24小时收缩压变异性在结果组之间存在统计学差异,但平均差异(95%置信区间)未超过MDD阈值。各组间收缩压及收缩压降低幅度无显著差异。在倾向评分匹配分析中,任何血压测量值和结果之间没有统计学差异。结论:我们的研究结果表明,尽管在ATACH-2预后良好和预后较差的患者之间收缩压变异性有统计学意义上的差异,但由于这些差异在测量噪声范围内,因此不符合临床相关性的阈值。倾向评分匹配分析表明,总血压测量值与结果之间的关联对分析方法来说并不稳健。这些发现强调在解释临床决策的事后发现时需要谨慎。
期刊介绍:
Neurocritical Care is a peer reviewed scientific publication whose major goal is to disseminate new knowledge on all aspects of acute neurological care. It is directed towards neurosurgeons, neuro-intensivists, neurologists, anesthesiologists, emergency physicians, and critical care nurses treating patients with urgent neurologic disorders. These are conditions that may potentially evolve rapidly and could need immediate medical or surgical intervention. Neurocritical Care provides a comprehensive overview of current developments in intensive care neurology, neurosurgery and neuroanesthesia and includes information about new therapeutic avenues and technological innovations. Neurocritical Care is the official journal of the Neurocritical Care Society.