Cloß Katharina, Verket Marlo, Müller-Wieland Dirk, Marx Nikolaus, Schuett Katharina, Jost Edgar, Crysandt Martina, Beier Fabian, Brümmendorf Tim H, Kobbe Guido, Brandts Julia, Jacobsen Malte
Department of Internal Medicine I, Medical Faculty, RWTH Aachen University, Aachen, Germany.
Department of Internal Medicine IV, Medical Faculty, RWTH Aachen University, Aachen, Germany.
Digit Health. 2024 Mar 5;10:20552076241233998. doi: 10.1177/20552076241233998. eCollection 2024 Jan-Dec.
This review aims to systematically map and categorize the current state of wearable applications among oncology patients and to identify determinants impeding clinical implementation.
A Medline, Embase and clinicaltrials.gov search identified journal articles, conference abstracts, letters, reports, dissertations and registered studies on the use of wearables in patients with malignancies published up to 10 November 2021.
Of 2509 records identified, 112 met the eligibility criteria. Of these, 9.8% (11/112) were RCTs and 47.3% (53/112) of publications were observational. Wearables were investigated pre-treatment (2.7%; 3/112), during treatment (34.8%; 39/112), post-treatment (17.9%; 20/112), in survivors (27.7%; 31/112) and in non-specified or multiple treatment phases (17.0%; 19/112). Medical-grade wearables were applied in 22.3% (25/112) of publications. Primary objectives ranged from technical feasibility (8.0%; 9/112), user feasibility (42.9%; 48/112) and correlational analysis (40.2%; 45/112) to outcome change analysis (8.9%; 10/112). Outcome change was mostly investigated regarding physical activity improvement (80.0%; 8/10). Most publications (42.9%; 48/112) and registered studies (39.3%; 24/61) featured multiple cancer types, with breast cancer as the most prevalent specific type (22.3% in publications, 16.4% in registered studies).
Most studies among oncology patients using wearables are focused on assessing the user feasibility of consumer-grade wearables, whereas rates of RCTs assessing clinical efficacy are low. Substantial improvements in clinically relevant endpoints by the use of wearables, such as morbidity and mortality are yet to be demonstrated.
本综述旨在系统梳理和分类肿瘤患者可穿戴设备应用的现状，并确定阻碍临床应用的决定因素。
通过检索Medline、Embase和clinicaltrials.gov，确定截至2021年11月10日发表的关于恶性肿瘤患者使用可穿戴设备的期刊文章、会议摘要、信件、报告、论文和注册研究。
在检索到的2509条记录中，112条符合纳入标准。其中，9.8%（11/112）为随机对照试验（RCT），47.3%（53/112）的出版物为观察性研究。可穿戴设备在治疗前（2.7%；3/112）、治疗期间（34.8%；39/112）、治疗后（17.9%；20/112）、幸存者（27.7%；31/112）以及未明确或多个治疗阶段（17.0%；19/112）进行了研究。22.3%（25/112）的出版物应用了医疗级可穿戴设备。主要目标包括技术可行性（8.0%；9/112）、用户可行性（42.9%；48/112）、相关性分析（40.2%；45/112）以及结局变化分析（8.9%；10/112）。结局变化大多围绕身体活动改善情况进行研究（80.0%；8/10）。大多数出版物（42.9%；48/112）和注册研究（39.3%；24/61）涉及多种癌症类型，其中乳腺癌是最常见的特定类型（在出版物中占22.3%，在注册研究中占16.4%）。
大多数针对肿瘤患者使用可穿戴设备的研究集中在评估消费级可穿戴设备的用户可行性，而评估临床疗效的随机对照试验比例较低。使用可穿戴设备在诸如发病率和死亡率等临床相关终点方面的显著改善尚未得到证实。
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