Melbourne School of Health Sciences, Florey Institute of Neuroscience and Mental Health and NHMRC Centre of Research Excellence in Stroke Rehabilitation and Brain Recovery (K.S.H.), University of Melbourne, Heidelberg, Australia.
Melbourne Medical School (L.C.), University of Melbourne, Parkville, Australia.
Stroke. 2021 Jan;52(2):761-769. doi: 10.1161/STROKEAHA.120.032496. Epub 2021 Jan 12.
Dose articulation is a universal issue of intervention development and testing. In stroke recovery, dose of a nonpharmaceutical intervention appears to influence outcome but is often poorly reported. The challenges of articulating dose in nonpharmacological stroke recovery research include: (1) the absence of specific internationally agreed dose reporting guidelines; (2) inadequate conceptualization of dose, which is multidimensional; and (3) unclear and inconsistent terminology that incorporates the multiple dose dimensions. To address these challenges, we need a well-conceptualized and consistent approach to dose articulation that can be applied across stroke recovery domains to stimulate critical thinking about dose during intervention development, as well as promote reporting of planned intervention dose versus actually delivered dose. We followed the Design Research Paradigm to develop a framework that guides how to articulate dose, conceptualizes the multidimensional nature and systemic linkages between dose dimensions, and provides reference terminology for the field. Our framework recognizes that dose is multidimensional and comprised of a duration of days that contain individual sessions and episodes that can be active (time on task) or inactive (time off task), and each individual episode can be made up of information about length, intensity, and difficulty. Clinical utility of this framework was demonstrated via hypothetical application to preclinical and clinical domains of stroke recovery. The suitability of the framework to address dose articulation challenges was confirmed with an international expert advisory group. This novel framework provides a pathway for better articulation of nonpharmacological dose that will enable transparent and accurate description, implementation, monitoring, and reporting, in stroke recovery research.
剂量表达是干预措施开发和测试的普遍问题。在脑卒中康复中，非药物干预措施的剂量似乎会影响结果，但往往报告得很差。在非药物性脑卒中康复研究中，准确表达剂量面临的挑战包括：（1）缺乏特定的国际公认的剂量报告指南；（2）剂量概念化不足，剂量具有多维性；（3）术语不明确且不一致，包含了多种剂量维度。为了解决这些挑战，我们需要一种概念化良好且一致的剂量表达方法，可应用于脑卒中康复的各个领域，以促进在干预措施开发过程中对剂量的深入思考，并促进报告计划干预剂量与实际提供的剂量。我们遵循设计研究范式来开发一个框架，指导如何表达剂量，概念化剂量的多维性质和剂量维度之间的系统联系，并为该领域提供参考术语。我们的框架认识到剂量是多维的，由持续天数组成，包含单独的治疗课程和治疗阶段，这些阶段可以是主动的（任务时间）或被动的（任务间隙时间），并且每个单独的治疗阶段可以由长度、强度和难度方面的信息组成。通过对脑卒中康复的临床前和临床领域的假设应用，证明了该框架的临床实用性。国际专家咨询小组确认了该框架解决剂量表达挑战的适用性。该新框架为更好地表达非药物剂量提供了途径，将使脑卒中康复研究中的描述、实施、监测和报告更加透明和准确。
