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有意义的变化:界定医疗保健和临床研究中源自交互式和移动健康技术的终点指标变化的可解释性。

Meaningful change: Defining the interpretability of changes in endpoints derived from interactive and mHealth technologies in healthcare and clinical research.

作者信息

Byrom B, Breedon P, Tulkki-Wilke R, Platko J V

机构信息

Product Management, Signant Health, London, UK.

Medical Design Research Group, Nottingham Trent University, Nottingham, UK.

出版信息

J Rehabil Assist Technol Eng. 2020 Mar 16;7:2055668319892778. doi: 10.1177/2055668319892778. eCollection 2020 Jan-Dec.

Abstract

Immersive, interactive and mHealth technologies are increasingly being used in clinical research, healthcare and rehabilitation solutions. Leveraging technology solutions to derive new and novel clinical outcome measures is important to the ongoing assessment of clinical interventions. While demonstrating statistically significant changes is an important element of intervention assessment, understanding whether changes detected reflect changes of a magnitude that are considered meaningful to patients is equally important. We describe methodologies used to determine meaningful change and recommend that these techniques are routinely included in the development and testing of clinical assessment and rehabilitation technology solutions.

摘要

沉浸式、交互式和移动健康技术越来越多地应用于临床研究、医疗保健和康复解决方案中。利用技术解决方案得出新的和新颖的临床结果测量方法对于持续评估临床干预措施很重要。虽然证明具有统计学意义的变化是干预评估的一个重要因素,但了解检测到的变化是否反映了对患者有意义的量级变化同样重要。我们描述了用于确定有意义变化的方法,并建议在临床评估和康复技术解决方案的开发和测试中常规纳入这些技术。

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