Department of Oncology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Faculty of Health, University of Copenhagen, Copenhagen, Denmark.
JMIR Mhealth Uhealth. 2020 Nov 11;8(11):e22006. doi: 10.2196/22006.
Interest in the use of wearables in medical care is increasing. Wearables can be used to monitor different variables, such as vital signs and physical activity. A crucial point for using wearables in oncology is if patients already under the burden of severe disease and oncological treatment can accept and adhere to the device. At present, there are no specific recommendations for the use of wearables in oncology, and little research has examined the purpose of using wearables in oncology.
The purpose of this review is to explore the use of wearables in clinical trials during cancer treatment, with a special focus on adherence.
PubMed and EMBASE databases were searched prior and up to October 3, 2019, with no limitation in the date of publication. The search strategy was aimed at studies using wearables for monitoring adult patients with cancer during active antineoplastic treatment. Studies were screened independently by 2 reviewers by title and abstract, selected for inclusion and exclusion, and the full-text was assessed for eligibility. Data on study design, type of wearable used, primary outcome, adherence, and device outcome were extracted. Results were presented descriptively.
Our systematic search identified 1269 studies, of which 25 studies met our inclusion criteria. The types of cancer represented in the studies were breast (7/25), gastrointestinal (4/25), lung (4/25), and gynecologic (1/25); 9 studies had multiple types of cancer. Oncologic treatment was primarily chemotherapy (17/25). The study-type distribution was pilot/feasibility study (12/25), observational study (10/25), and randomized controlled trial (3/25). The median sample size was 40 patients (range 7-180). All studies used a wearable with an accelerometer. Adherence varied across studies, from 60%-100% for patients wearing the wearable/evaluable sensor data and 45%-94% for evaluable days, but was differently measured and reported. Of the 25 studies, the most frequent duration for planned monitoring with a wearable was 8-30 days (13/25). Topics for wearable outcomes were physical activity (19/25), circadian rhythm (8/25), sleep (6/25), and skin temperature (1/25). Patient-reported outcomes (PRO) were used in 17 studies; of the 17 PRO studies, only 9 studies reported correlations between the wearable outcome and the PRO.
We found that definitions of outcome measures and adherence varied across studies, and limited consensus among studies existed on which variables to monitor during treatment. Less heterogeneity, better consensus in terms of the use of wearables, and established standards for the definitions of wearable outcomes and adherence would improve comparisons of outcomes from studies using wearables. Adherence, and the definition of such, seems crucial to conclude on data from wearable studies in oncology. Additionally, research using advanced wearable devices and active use of the data are encouraged to further explore the potential of wearables in oncology during treatment. Particularly, randomized clinical studies are warranted to create consensus on when and how to implement in oncological practice.
人们对可穿戴设备在医疗保健中的应用越来越感兴趣。可穿戴设备可用于监测各种变量，如生命体征和身体活动。在肿瘤学中使用可穿戴设备的一个关键问题是，已经承受严重疾病和肿瘤治疗负担的患者是否能够接受并坚持使用该设备。目前，肿瘤学中使用可穿戴设备没有具体的建议，也很少有研究探讨在肿瘤学中使用可穿戴设备的目的。
本综述的目的是探讨可穿戴设备在癌症治疗临床试验中的应用，特别关注依从性。
在 2019 年 10 月 3 日之前和之后，我们在 PubMed 和 EMBASE 数据库中进行了搜索，没有对出版物日期进行限制。搜索策略旨在研究使用可穿戴设备监测正在接受积极抗肿瘤治疗的成年癌症患者。两名审查员独立筛选标题和摘要，选择纳入和排除标准，并评估全文的合格性。提取研究设计、使用的可穿戴设备类型、主要结果、依从性和设备结果的数据。结果以描述性方式呈现。
我们的系统搜索确定了 1269 项研究，其中 25 项研究符合纳入标准。研究中涉及的癌症类型包括乳腺癌（7/25）、胃肠道癌（4/25）、肺癌（4/25）和妇科癌症（1/25）；9 项研究有多种癌症类型。肿瘤治疗主要是化疗（17/25）。研究类型分布为初步/可行性研究（12/25）、观察性研究（10/25）和随机对照试验（3/25）。中位样本量为 40 例患者（范围 7-180）。所有研究均使用带加速度计的可穿戴设备。依从性因研究而异，从穿戴可穿戴设备/可评估传感器数据的患者的 60%-100%到可评估天数的 45%-94%，但测量和报告方式不同。在 25 项研究中，计划使用可穿戴设备监测的最常见持续时间为 8-30 天（13/25）。可穿戴设备结果的主题是身体活动（19/25）、昼夜节律（8/25）、睡眠（6/25）和皮肤温度（1/25）。患者报告的结果（PRO）在 17 项研究中使用；在 17 项 PRO 研究中，只有 9 项研究报告了可穿戴设备结果与 PRO 之间的相关性。
我们发现，研究之间的结果衡量标准和依从性定义存在差异，并且在治疗期间监测哪些变量方面，研究之间也存在共识。在使用可穿戴设备方面，减少异质性、达成更好的共识，并为可穿戴设备结果和依从性的定义建立标准，将有助于比较使用可穿戴设备进行的研究的结果。依从性及其定义至关重要，这似乎是得出肿瘤学中可穿戴设备研究数据结论的关键。此外，鼓励使用先进的可穿戴设备和积极使用数据，以进一步探索可穿戴设备在治疗期间在肿瘤学中的潜力。特别是需要进行随机临床试验，以就何时以及如何在肿瘤学实践中实施达成共识。
