• 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Journal of stroke and cerebrovascular diseases: The official journal of National Stroke Association >Sequential Multiple Assignment Randomized Trials: An Opportunity for Improved Design of Stroke Reperfusion Trials
【24h】

Sequential Multiple Assignment Randomized Trials: An Opportunity for Improved Design of Stroke Reperfusion Trials

机译：顺序多分配随机试验：改进中风再灌注试验设计的机会

获取原文
获取原文并翻译 | 示例
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

Background: Modern clinical trials in stroke reperfusion fall into 2 categories: alternative systemic pharmacological regimens to alteplase and "rescue" endovascular approaches using targeted thrombectomy devices and/or medications delivered directly for persistently occluded vessels. Clinical trials in stroke have not evaluated how initial pharmacological thrombolytic management might influence subsequent rescue strategy. A sequential multiple assignment randomized trial (SMART) is a novel trial design that can test these dynamic treatment regimens and lead to treatment guidelines that more closely mimic practice. Aim: To characterize a SMART design in comparison to traditional approaches for stroke reperfusion trials. Methods: We conducted a numerical simulation study that evaluated the performance of contrasting acute stroke clinical trial designs of both initial reperfusion and rescue therapy. We compare a SMART design where the same patients are followed through initial reperfusion and rescue therapy within 1 trial to a standard phase III design comparing 2 reperfusion treatments and a separate phase II futility design of rescue therapy in terms of sample size, power, and ability to address particular research questions. Results: Traditional trial designs can be well powered and have optimal design characteristics for independent treatment effects. When treatments, such as the reperfusion and rescue therapies, may interact, commonly used designs fail to detect this. A SMART design, with similar sample size to standard designs, can detect treatment interactions. Conclusions: The use of SMART designs to investigate effective and realistic dynamic treatment regimens is a promising way to accelerate the discovery of new, effective treatments for stroke. (C) 2017 National Stroke Association. Published by Elsevier Inc. All rights reserved.
机译：背景：中风再灌注的现代临床试验分为两类：替代阿替普酶的全身药理学方案和使用靶向血栓切除装置和/或直接给持续闭塞的血管提供药物的“拯救”血管内途径。中风的临床试验尚未评估最初的药物溶栓治疗可能如何影响后续的救援策略。序贯多任务随机试验（SMART）是一种新的试验设计，可以测试这些动态治疗方案，并得出更接近实践的治疗指南。目的：与传统中风再灌注试验方法相比，描述智能设计的特点。方法：我们进行了一项数值模拟研究，评估了初始再灌注和抢救治疗两种急性脑卒中临床试验设计的对比性能。我们比较了一个SMART设计，即在1次试验中对相同的患者进行初始再灌注和抢救治疗，以及一个标准的III期设计，比较了2次再灌注治疗和一个单独的II期抢救治疗无效设计的样本量、功效和解决特定研究问题的能力。结果：传统的试验设计可以很好地发挥作用，并具有独立治疗效果的最佳设计特征。当再灌注和抢救疗法等治疗可能相互作用时，常用的设计无法检测到这一点。与标准设计具有相似样本量的智能设计可以检测治疗相互作用。结论：使用智能设计来研究有效和现实的动态治疗方案是加速发现新的有效中风治疗方法的一个有希望的途径。（C） 2017年全国中风协会。爱思唯尔公司出版。版权所有。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号