A stroke recovery trial development framework: Consensus-based core recommendations from the Second Stroke Recovery and Rehabilitation Roundtable

A stroke recovery trial development framework: Consensus-based core recommendations from the Second Stroke Recovery and Rehabilitation Roundtable
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DOI:
10.1177/1747493019879657
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发表时间:
2019-10-29
影响因子:
6.7
通讯作者:
Cramer, Steven C.
Cramer, Steven C.
中科院分区:
医学2区
文献类型:
--
作者:
Bernhardt, Julie;Hayward, Kathryn S.;Cramer, Steven C.

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中风恢复和康复圆桌会议(SRRR)的一个主要目标是加速有效治疗的发展,以提高中风恢复超过预期自发发生或与当前的方法。在本文中,我们描述了下一代中风恢复治疗试验的关键问题,并提出了中风恢复和康复圆桌会议试验开发框架(SRRR-TDF)。一个范例(上肢恢复试验),以证明该框架的实用性,以指导在试验开发的GO,NO-GO决策过程。
A major goal of the Stroke Recovery and Rehabilitation Roundtable (SRRR) is to accelerate development of effective treatments to enhance stroke recovery beyond that expected to occur spontaneously or with current approaches. In this paper, we describe key issues for the next generation of stroke recovery treatment trials and present the Stroke Recovery and Rehabilitation Roundtable Trials Development Framework (SRRR-TDF). An exemplar (an upper limb recovery trial) is presented to demonstrate the utility of this framework to guide the GO, NO-GO decision-making process in trial development.