临床前和临床试验的控制干预设计:来自第三届中风恢复和康复圆桌会议的基于共识的核心建议
Kathryn S Hayward1, Emily J Dalton1, Jessica Barth2
1The University of Melbourne, Melbourne, VIC, Australia.
概括
选择正确的对照比较器对于中风恢复试验至关重要. 控制设计 (CONSIGN) 工具帮助研究人员选择,描述和报告强大的康复研究的比较器.
科学领域:
- 神经康复疗法 神经康复疗法
- 临床试验设计 临床试验设计
- 脑卒中恢复研究研究
背景情况:
- 对照对照选择是中风恢复和康复试验中的一个关键问题.
- 实验干预的好处是相对于所选择的比较器而言确立的.
- 强有力的推理对比器的选择提高了试验的完整性和发现的有效性.
研究的目的:
- 解决中风康复研究对照比较器设计方面的挑战.
- 引入CONTROL DeSIGN (CONSIGN) 决策支持工具,以加强对比器的选择,描述和报告.
- 为改善神经康复中对照比较器设计提供指导和建议.
主要方法:
- 一个中风恢复和康复圆桌会议 (SRRR) 工作组使用图形理论投票来对控制对比器设计中的挑战进行排名.
- 开发基于网络的CONtrol DeSIGN (CONSIGN) 决策支持工具.
- 与130多名神经康复研究人员一起对CONSIGN工具进行试点测试,并通过多轮精细化.
主要成果:
- "确定合适类型的控制"被评为容易和非常重要.
- "常规护理中的变化"被评为难度和低重要性.
- "了解控制内容及其与实验干预的区别"被评为非常重要但不容易.
结论:
- 该 CONSIGN 工具提供了一个结构化,七步的方法来指导用户通过控制比较器设计.
- 在临床前,情绪,失语和运动恢复方面的示例试验证明了CONSIGN的实际应用.
- 定义了六项共识建议,以改善跨研究领域和学科的对照对比器选择.
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