Medical Extended Reality Trials: Building Robust Comparators, Controls, and Sham.
Medical Extended Reality Trials: Building Robust Comparators, Controls, and Sham.
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DOI：
10.2196/45821
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发表时间：
2023-11-22
影响因子：
7.4
通讯作者：
中科院分区：
文献类型：
--
作者：
医学扩展现实（MXR）领域迅猛的发展和研究速度证明了它在医疗保健和医学领域的应用前景。与这种增长相比，能够确定这些干预措施的功效和有效性的严格临床试验相对较少。阐明临床各领域以及MXR应用的作用机制是另一个主要的需求领域。实现这些目标的一个主要障碍是缺乏试验设计的框架，更具体地说，是缺乏对能够有效解决MXR独特要素的合适对照的选择。本文阐述了一个用于设计对照、模拟条件和比较对象的框架，以及对MXR试验设计提出的一些考虑因素。对模拟条件的设计给予了特别关注。改进设计将使研究结果更具说服力，并有助于形成可推广的知识，从而应用于各种MXR干预措施。
The explosive pace of development and research in medical extended reality (MXR) is a testament to its promise for health care and medicine. In comparison with this growth, there is a relative sparsity of rigorous clinical trials that establish the efficacy and effectiveness of these interventions. Explicating mechanisms of action across clinical areas and MXR applications is another major area of need. A primary impediment to these goals is a lack of frameworks for trial design, more specifically, the selection of appropriate controls that effectively address unique elements of MXR. This paper delineates a framework for designing controls, sham conditions, and comparators, as well as proposed considerations for MXR trial designs. Special consideration is given to the design of sham conditions. Improved designs would enable more robust findings and the development of generalizable knowledge that could be adopted across MXR interventions.
影响因子：
2.9
作者：
Zhu, Binbin;Zhou, Yanling;Weng, Qiuyan;Luo, Wenjun;He, Xiuchao;Jin, Lufei;Wang, Qinwen;Gao, Bin;Harb, Ahmad Khaled Ahmad;Wang, Jianhua
通讯作者：
Wang, Jianhua
影响因子：
2.5
作者：
Smits, Merlijn;van Goor, Harry;Kallewaard, Jan-Willem;Verbeek, Peter-Paul;Ludden, Geke D S
通讯作者：
Ludden, Geke D S
影响因子：
2.9
作者：
Elfeky, Adel;Treweek, Shaun;Hannes, Karin;Bruhn, Hanne;Fraser, Cynthia;Gillies, Katie
通讯作者：
Gillies, Katie