提出了一种多领域的数字模型,用于捕捉肿瘤学中的功能状态和与健康相关的生活质量。
A proposed multi-domain, digital model for capturing functional status and health-related quality of life in oncology.
机构信息
Koneksa Health, New York, New York, USA.
Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, Massachusetts, USA.
出版信息
Clin Transl Sci. 2024 Jan;17(1):e13712. doi: 10.1111/cts.13712.
Whereas traditional oncology clinical trial endpoints remain key for assessing novel treatments, capturing patients' functional status is increasingly recognized as an important aspect for supporting clinical decisions and assessing outcomes in clinical trials. Existing functional status assessments suffer from various limitations, some of which may be addressed by adopting digital health technologies (DHTs) as a means of collecting both objective and self-reported outcomes. In this mini-review, we propose a device-agnostic multi-domain model for oncology capturing functional status, which includes physical activity data, vital signs, sleep variables, and measures related to health-related quality of life enabled by connected digital tools. By using DHTs for all aspects of data collection, our proposed model allows for high-resolution measurement of objective data as patients navigate their daily lives outside of the hospital setting. This is complemented by electronic questionnaires administered at intervals appropriate for each instrument. Preliminary testing and practical considerations to address before adoption are also discussed. Finally, we highlight multi-institutional pre-competitive collaborations as a means of successfully transitioning the proposed digitally enabled data collection model from feasibility studies to interventional trials and care management.
虽然传统的肿瘤学临床试验终点仍然是评估新疗法的关键,但越来越多的人认识到,在临床试验中,评估患者的功能状态是支持临床决策和评估结果的一个重要方面。现有的功能状态评估方法存在各种局限性,其中一些局限性可以通过采用数字健康技术(DHT)来解决,将其作为收集客观和自我报告结果的一种手段。在这篇迷你综述中,我们提出了一种与设备无关的肿瘤学多领域模型,用于捕捉功能状态,该模型包括体力活动数据、生命体征、睡眠变量以及通过互联数字工具实现的与健康相关的生活质量相关的测量。通过使用 DHT 来收集数据的所有方面,我们提出的模型允许在患者在医院环境之外的日常生活中对客观数据进行高分辨率测量。这通过为每个仪器都设置适当的时间间隔来管理电子问卷来补充。我们还讨论了在采用之前需要进行初步测试和解决的实际考虑因素。最后,我们强调多机构的预竞争合作,作为将拟议的数字化数据收集模型从可行性研究成功过渡到干预性试验和护理管理的一种手段。