Trials of Intervention Principles: Evaluation Methods for Evolving Behavioral Intervention Technologies
Trials of Intervention Principles: Evaluation Methods for Evolving Behavioral Intervention Technologies
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DOI：
10.2196/jmir.4391
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发表时间：
2015-07-01
影响因子：
7.4
通讯作者：
Cheung, Ken
中科院分区：
文献类型：
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作者：
Mohr, David C.;Schueller, Stephen M.;Cheung, Ken
近年来，越来越多的人讨论了传统随机对照试验(RCT)方法在评估电子健康和移动健康干预措施方面的局限性，特别是在评估期间锁定这些干预措施的要求。锁定这些干预措施将锁定缺陷，并消除提高质量和适应不断变化的技术环境的机会，这往往导致在试验结果公布时对过时的工具进行验证。此外，由于行为干预技术在真实世界的部署过程中经常变化，即使在真实世界中部署了经过测试的干预，其保质期也将是有限的。我们认为，如果RCT专注于对干预原则(而不是干预的特定锁定版本)的评估，允许基于核心干预原则对行为干预技术进行持续的质量改进修改，同时不断改进功能并保持技术通用性，则RCT将具有更大的科学和公共卫生价值。本文是对干预原则(TIPS)试验的框架和方法的初步建议，旨在最大限度地减少干预技术试验中的改变的风险，并最大限度地增加获得知识的潜力。与专注于单一干预技术的试验相比，关注使用临床和使用结果来评估干预原则有可能提供更普遍和持久的信息。
In recent years, there has been increasing discussion of the limitations of traditional randomized controlled trial (RCT) methodologies for the evaluation of eHealth and mHealth interventions, and in particular, the requirement that these interventions be locked down during evaluation. Locking down these interventions locks in defects and eliminates the opportunities for quality improvement and adaptation to the changing technological environment, often leading to validation of tools that are outdated by the time that trial results are published. Furthermore, because behavioral intervention technologies change frequently during real-world deployment, even if a tested intervention were deployed in the real world, its shelf life would be limited. We argue that RCTs will have greater scientific and public health value if they focus on the evaluation of intervention principles (rather than a specific locked-down version of the intervention), allowing for ongoing quality improvement modifications to the behavioral intervention technology based on the core intervention principles, while continuously improving the functionality and maintaining technological currency. This paper is an initial proposal of a framework and methodology for the conduct of trials of intervention principles (TIPs) aimed at minimizing the risks of in-trial changes to intervention technologies and maximizing the potential for knowledge acquisition. The focus on evaluation of intervention principles using clinical and usage outcomes has the potential to provide more generalizable and durable information than trials focused on a single intervention technology.