Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK.
Int J Stroke. 2013 Jan;8(1):18-24. doi: 10.1111/j.1747-4949.2012.00973.x.
Stroke survivors experience complex combinations of impairments, activity limitations, and participation restrictions. The essential components of stroke rehabilitation remain elusive. Determining efficacy in randomized controlled trials (RCTs) is challenging; there is no commonly agreed primary outcome measure for rehabilitation trials. Clinical guidelines depend on proof of efficacy in RCTs and meta-analyses. However, diverse trial aims, differing methods, inconsistent data collection, and use of multiple assessment tools hinder comparability across trials. Consistent data collection in acute stroke trials has facilitated meta-analyses to inform trial design and clinical practice. With few exceptions, inconsistent data collection has hindered similar progress in stroke rehabilitation research. There is an urgent need for the routine collection of a core dataset of common variables in rehabilitation trials. The European Stroke Organisation Outcomes Working Group, the National Institutes of Neurological Disorders and Stroke Common Data Elements project, and the Collaborative Stroke Audit and Research project have called for consistency in data collection in stroke trials. Standardizing data collection can decrease study start up times, facilitate data sharing, and inform clinical guidelines. Although achieving consensus on which outcome measures to use in stroke rehabilitation trials is a considerable task, perhaps a feasible starting point is to achieve consistency in the collection of data on demography, stroke severity, and stroke onset to inclusion times. Longer term goals could include the development of a consensus process to establish the core dataset. This should be endorsed by researchers, funders, and journal editors in order to facilitate sustainable change.
中风幸存者经历复杂的损伤、活动受限和参与受限组合。中风康复的基本组成部分仍然难以捉摸。在随机对照试验（RCT）中确定疗效具有挑战性；康复试验没有普遍同意的主要结局衡量标准。临床指南依赖于 RCT 和荟萃分析的疗效证明。然而，不同的试验目的、不同的方法、不一致的数据收集和使用多种评估工具阻碍了试验之间的可比性。急性中风试验中一致的数据收集促进了荟萃分析，以指导试验设计和临床实践。除了少数例外，不一致的数据收集阻碍了中风康复研究的类似进展。在康复试验中常规收集常见变量的核心数据集非常有必要。欧洲中风组织结局工作组、美国国立神经病学和中风疾病共同数据元素项目以及协作性中风审核和研究项目都呼吁在中风试验中保持数据收集的一致性。标准化数据收集可以减少研究启动时间，促进数据共享，并为临床指南提供信息。尽管就中风康复试验中使用哪些结局衡量标准达成共识是一项艰巨的任务，但也许一个可行的起点是在人口统计学、中风严重程度和中风发作到纳入时间的数据收集方面实现一致性。长期目标可能包括建立共识过程以确定核心数据集。这应该得到研究人员、资助者和期刊编辑的支持，以促进可持续的变革。
