Global Differences in Patient Characteristics, Case Management and Outcomes in Intracerebral Hemorrhage: The Factor Seven for Acute Hemorrhagic Stroke (FAST) Trial
Global Differences in Patient Characteristics, Case Management and Outcomes in Intracerebral Hemorrhage: The Factor Seven for Acute Hemorrhagic Stroke (FAST) Trial
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DOI：
10.1159/000219298
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发表时间：
2009-01-01
影响因子：
2.9
通讯作者：
Steiner, Thorsten
中科院分区：
文献类型：
--
作者：
Christensen, Michael C.;Broderick, Joseph;Steiner, Thorsten
背景资料：各国卒中后的结局差异很大，但脑出血（ICH）后的变化程度仍不清楚。本研究检查了最近一项多国试验中ICH后结局的差异，并探讨了患者严重程度和病例管理差异对观察到的变化的影响。研究方法：急性出血性卒中的第七因子是一项随机、多国、双盲、安慰剂对照试验，于2005年5月至2007年2月在22个国家的122个研究中心进行。我们调查了14个招募人数最多的国家的基线患者特征、病例管理和临床结局的差异。使用回归分析检查死亡率和功能结局的国家间差异，同时调整观察到的患者严重程度（病例组合）和病例管理的差异。结果如下：801名患者具有关于基线特征、病例管理和临床结果的完整数据，并且在一个为试验贡献>= 20名患者的国家招募。在ICH发作后90天，在未校正的死亡率（p = 0.001）和功能结局（p = 0.001）方面观察到国家间存在显著差异。当首先调整病例组合的差异，其次调整病例管理的差异时，结果的差异仍然很大，但国家之间的差异随着每一级调整而减少。死亡率的重要决定因素是年龄、基线ICH和脑室内出血量、基线神经功能缺损、吸烟状态、机械通气的使用、住院总时间、入院前24小时内血压降低1 - 20%和水肿管理。还通过年龄、基线ICH体积和基线神经功能缺损以及入院前5天内进行的神经外科手术和镇静来确定功能结局不良。结论：即使在对病例组合和病例管理的差异进行全面调整后，ICH后的临床结局仍存在显著的全球差异。这很可能是由于病例组合和病例管理方面的不可测量的变化。鼓励在其他多国卒中试验的数据集中进行类似的研究，以进一步研究临床结局的国家和地区差异。版权所有（C）2009 S. Karger AG，巴塞尔
Background: The outcomes after stroke vary considerably between countries, yet the extent of the variation after intracerebral hemorrhage (ICH) remains unknown. This study examines differences in outcomes after ICH in a recent multinational trial, and explores the effect of differences in patient severity and case management for the variations observed. Methods: Factor Seven for Acute Hemorrhagic Stroke was a randomized, multinational, double-blind, placebo-controlled trial conducted between May 2005 and February 2007 at 122 sites in 22 countries. We investigated differences in baseline patient characteristics, case management and clinical outcomes across the 14 highest recruiting countries. Between-country differences in mortality and functional outcomes were examined using regression analysis while adjusting for differences in observed patient severity (case mix) and case management. Results: Eight hundred and one patients had complete data on baseline characteristics, case management and clinical outcomes and were recruited in a country that contributed >= 20 patients to the trial. Significant differences were observed between the countries in unadjusted mortality rates (p = 0.001) and functional outcomes (p = 0.001) at 90 days after ICH onset. When first adjusting for differences in case mix, and secondly differences in case management, the differences in outcomes remained significant, yet the variation between countries was reduced with each level of adjustment. Significant determinants of mortality were age, baseline ICH and intraventricular hemorrhage volume, baseline neurological deficit, smoking status, use of mechanical ventilation, total length of hospital stay, reduction in blood pressure between 1 and 20% during the first 24 h of admission and edema management. Poor functional outcomes were also determined by age, baseline ICH volume and baseline neurological deficit as well as neurosurgical procedures performed and sedation during the first 5 days of admission. Conclusion: Significant global differences exist in the clinical outcomes after ICH, even after comprehensively adjusting for differences in case mix and case management. This is most likely due to unmeasured variation in case mix and case management. Similar research is encouraged in data sets of other multinational stroke trials to further investigate country-level and regional differences in clinical outcomes. Copyright (C) 2009 S. Karger AG, Basel