目的:关于在临床研究中使用可穿戴设备的信息,包括疾病领域,干预技术,设备类型的趋势,和样本量目标,仍然难以捉摸。因此,我们在研究计划中对腕带可穿戴设备相关的临床研究趋势进行了全面回顾,并研究了它们在临床研究中的应用。
方法:由于本研究确定了在临床研究计划阶段采用可穿戴设备的趋势,包括特定的疾病领域和目标干预病例数,我们搜索了ClinicalTrials.gov-一个注册和传播临床研究的重要平台.由于手腕穿戴设备占据了很大的市场份额,我们专注于手腕穿戴设备,并从中选择了最具代表性的型号。主要分析主要集中在可穿戴设备上,以方便数据分析和解释,但其他可穿戴设备也被调查以供参考。我们用关键字\"ActiGraph搜索ClinicalTrials.gov,\"\"AppleWatch,\"\"Empatica,\"\"Fitbit,\"\"Garmin,“和”可穿戴设备“获得截至2022年8月21日发表的研究。最初的搜索产生了3214项研究。排除重复的国家临床试验研究后(除可穿戴设备外,不同设备类型之间允许重叠),我们的分析集中在2930项研究上,包括简单的,时间序列,以及对各种变量的特定类型评估。
结果:总体而言,自2012年以来,越来越多的临床研究将可穿戴设备纳入其中。虽然ActiGraph和Fitbit最初占据了这一局面,其他设备的使用稳步增加,约占2015年后总数的10%。观察性研究数量超过干预性研究,行为和基于设备的干预尤其普遍。关于疾病类型,癌症和心血管疾病约占总数的20%。值得注意的是,114项研究在其临床研究的背景下同时采用了多种设备。
结论:我们的发现表明,自2012年以来,可穿戴设备在各种疾病领域的数据收集和行为干预中的利用率一直在增加。过去3年研究数量的增加尤为显著,表明这一趋势将在未来继续加速。经过彻底验证的设备及其评估方法,证实了他们的准确性,遵守既定的法律法规可能会在评估中发挥关键作用,允许远程临床试验。此外,利用应用程序的行为干预治疗变得越来越广泛,我们希望看到更多的例子,将导致他们批准作为程序化的医疗设备在未来。
OBJECTIVE: Information regarding the use of wearable devices in clinical research, including disease areas, intervention techniques, trends in device types, and sample size targets, remains elusive. Therefore, we conducted a comprehensive review of clinical research trends related to wristband wearable devices in research planning and examined their applications in clinical investigations.
METHODS: As this study identified trends in the adoption of wearable devices during the planning phase of clinical research, including specific disease areas and targeted number of intervention cases, we searched ClinicalTrials.gov-a prominent platform for registering and disseminating clinical research. Since wrist-worn devices represent a large share of the market, we focused on wrist-worn devices and selected the most representative models among them. The main analysis focused on major wearable devices to facilitate data analysis and interpretation, but other wearables were also surveyed for reference. We searched ClinicalTrials.gov with the keywords \"
ActiGraph,\"\"Apple Watch,\"\"Empatica,\"\"Fitbit,\"\"Garmin,\" and \"wearable devices\" to obtain studies published up to 21 August 2022. This initial search yielded 3214 studies. After excluding duplicate National Clinical Trial studies (the overlap was permissible among different device types except for wearable devices), our analysis focused on 2930 studies, including simple, time-series, and type-specific assessments of various variables.
RESULTS: Overall, an increasing number of clinical studies have incorporated wearable devices since 2012. While
ActiGraph and Fitbit initially dominated this landscape, the use of other devices has steadily increased, constituting approximately 10% of the total after 2015. Observational studies outnumbered intervention studies, with behavioral and device-based interventions being particularly prevalent. Regarding disease types, cancer and cardiovascular diseases accounted for approximately 20% of the total. Notably, 114 studies adopted multiple devices simultaneously within the context of their clinical investigations.
CONCLUSIONS: Our findings revealed that the utilization of wearable devices for data collection and behavioral interventions in various disease areas has been increasing over time since 2012. The increase in the number of studies over the past 3 years has been particularly significant, suggesting that this trend will continue to accelerate in the future. Devices and their evaluation methods that have undergone thorough validation, confirmed their accuracy, and adhered to established legal regulations will likely assume a pivotal role in evaluations, allowing for remote clinical trials. Moreover, behavioral intervention therapy utilizing apps is becoming more extensive, and we expect to see more examples that will lead to their approval as programmed medical devices in the future.