The use of the randomised controlled trial (RCT) design to evaluate the effectiveness of new interventions in aphasia has increased in recent years in response to calls for high quality evidence of the effectiveness of interventions for this population. This view-point article highlights some of the important considerations when designing a trial for an aphasia intervention, illustrated with decisions made when designing the Big CACTUS RCT for self-managed computer-based word finding therapy in aphasia. Considerations outlined include whether an RCT is needed, readiness for conducting an RCT, choice of comparators, randomisation options, blinding/masking, selection of outcome measures, pragmatic versus explanatory approaches, and fidelity measurement.


中文翻译：

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失语症临床试验的设计注意事项


近年来，随着对有关该人群干预措施有效性的高质量证据的呼吁，使用随机对照试验（RCT）设计评估失语症新干预措施的有效性有所增加。这篇观点文章重点介绍了设计失语症干预试验时的一些重要考虑因素，并举例说明了设计Big CACTUS RCT进行失语症自我管理基于计算机的单词发现疗法时所做出的决定。概述的考虑因素包括是否需要RCT，是否准备进行RCT，选择比较器，随机选择，盲目/掩盖，选择结果度量，务实与解释性方法以及保真度度量。