VivoSense Inc, Newport Coast, CA.
JCO Clin Cancer Inform. 2023 Sep;7:e2300055. doi: 10.1200/CCI.23.00055.
The burden of cancer cachexia on patients' health-related quality of life, specifically their physical functioning, is well documented, but clinical trials thus far have failed to show meaningful improvement in physical functioning. The purpose of this review is to summarize existing methods of assessing physical function in cancer cachexia, outline a path forward for measuring what is meaningful to patients using digital measures derived from digital health technologies (DHTs), and discuss the current landscape of digital measures from the clinical and regulatory standpoint.
For this narrative review, peer-reviewed articles were searched on PubMed, clinical trials records were searched on clinicaltrials.gov, and records of digital measures submitted for regulatory qualification were searched on the US Food and Drug Administration's Drug Development Tool Qualification Program database.
There are gaps in assessing aspects of physical function that matter to patients. Existing assessment methods such as patient-reported outcomes and objective performance outcomes have limitations, including their episodic nature and burden to patients. DHTs such as wearable sensors can capture real-world physical behavior continuously, passively, and remotely, and may provide a more comprehensive picture of patients' everyday functioning. Recent regulatory submissions showcase potential clinical implementation of digital measures in various therapeutic areas.
Digital measures of real-world physical behavior present an opportunity to detect and demonstrate improvements in physical functioning in cancer cachexia, but evidence-based development is critical. For their use in clinical and regulatory decision making, studies demonstrating meaningfulness to patients as well as feasibility and validation are necessary.
癌症恶病质给患者健康相关生活质量带来的负担，尤其是对其身体机能的影响，已有大量文献记载，但迄今为止的临床试验并未显示身体机能有明显改善。本综述旨在总结目前用于评估癌症恶病质患者身体机能的方法，概述使用数字健康技术（DHT）衍生的数字测量方法来衡量对患者有意义的内容的前进方向，并从临床和监管角度讨论数字测量方法的现状。
在本次叙述性综述中，在 PubMed 上搜索了同行评审的文章，在 clinicaltrials.gov 上搜索了临床试验记录，在美国食品和药物管理局的药物开发工具资格计划数据库中搜索了提交用于监管资格的数字测量记录。
在评估对患者重要的身体机能方面存在差距。现有的评估方法，如患者报告的结果和客观表现结果，存在局限性，包括其偶发性和对患者的负担。DHT 如可穿戴传感器可以连续、被动和远程地捕捉真实世界的身体行为，可能提供患者日常功能的更全面的图景。最近的监管提交展示了数字测量方法在各种治疗领域的潜在临床应用。
真实世界身体行为的数字测量为检测和证明癌症恶病质患者身体机能的改善提供了机会，但基于证据的开发至关重要。为了在临床和监管决策中使用这些数字测量方法，有必要证明对患者的意义、可行性和验证。
