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.
Neurorehabilitation and neural repair
|October 14, 2023
概括
选择合适的对照比较器对于中风恢复和康复试验至关重要. 控制设计 (CONSIGN) 工具帮助研究人员选择,描述和报告比较器,以提高试验完整性和研究结果.
科学领域:
- 神经科学是一个神经科学.
- 临床试验设计 临床试验设计
- 康复医学 康复医学 康复医学
背景情况:
- 对照对比剂的选择是中风恢复和康复试验设计的关键但具有挑战性的方面.
- 实验干预的好处是相对于所选择的比较物来评估的,需要仔细考虑其适当性和相关性.
- 强有力的推理对比器选择增强试验完整性和发现的有效性.
研究的目的:
- 识别和排名中风恢复和康复试验的对照比较器设计中的挑战.
- 开发一个决策支持工具,以应对在对比器选择,描述和报告方面遇到的挑战.
- 为改善研究中的控制比较器设计提供实际指导和建议.
主要方法:
- 一个中风恢复和康复圆桌会议 (SRRR) 工作组利用图形理论投票系统来对挑战进行排名.
- 开发基于网络的CONtrol DeSIGN (CONSIGN) 决策支持工具,包括七个步骤.
- 与130多名神经康复研究人员进行试点测试,并改进了该工具.
主要成果:
- 确定了关键挑战:"确定适当的控制类型" (简单,非常重要),"通常护理的变化" (困难,不重要),以及"理解控制内容" (不容易,非常重要).
- 该 CONSIGN 工具的开发和完善,以指导用户通过控制比较器设计.
- 四个示例试验证明了CONSIGN工具在不同恢复领域的实际应用.
结论:
- 该 CONSIGN 工具有效地解决了对照对比器选择,描述和报告中风恢复和康复研究的挑战.
- 制定了六项共识建议,以指导跨学科和跨界的未来研究.
- 通过像CONSIGN这样的工具来改进对比器选择,提高了中风康复研究的严谨性和影响.
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