Department of Rehabilitation Sciences, Ghent University, Corneel Heymanslaan 10, Entrance 46, Ghent, 9000, Belgium, 3293326915.
Department of Rehabilitation Sciences, KU Leuven, Leuven, Belgium.
JMIR Mhealth Uhealth. 2024 Nov 6;12:e56027. doi: 10.2196/56027.
Consumer-based wearables are becoming more popular and provide opportunities to track individual's clinical parameters remotely. However, literature about their criterion and known-groups validity is scarce.
This study aimed to assess the validity of the Fitbit Charge 4, a wrist-worn consumer-based wearable, to measure clinical parameters (ie, daily step count, resting heart rate [RHR], heart rate variability [HRV], respiratory rate [RR], and oxygen saturation) in patients with chronic obstructive pulmonary disease (COPD) and healthy controls in free-living conditions in Belgium by comparing it with medical-grade devices.
Participants wore the Fitbit Charge 4 along with three medical-grade devices: (1) Dynaport MoveMonitor for 7 days, retrieving daily step count; (2) Polar H10 for 5 days, retrieving RHR, HRV, and RR; and (3) Nonin WristOX2 3150 for 4 nights, retrieving oxygen saturation. Criterion validity was assessed by investigating the agreement between day-by-day measures of the Fitbit Charge 4 and the corresponding reference devices. Known-groups validity was assessed by comparing patients with COPD and healthy controls.
Data of 30 patients with COPD and 25 age- and gender-matched healthy controls resulted in good agreement between the Fitbit Charge 4 and the corresponding reference device for measuring daily step count (intraclass correlation coefficient [ICC2,1]=0.79 and ICC2,1=0.85, respectively), RHR (ICC2,1=0.80 and ICC2,1=0.79, respectively), and RR (ICC2,1=0.84 and ICC2,1=0.77, respectively). The agreement for HRV was moderate (healthy controls: ICC2,1=0.69) to strong (COPD: ICC2,1=0.87). The agreement in measuring oxygen saturation in patients with COPD was poor (ICC2,1=0.32). The Fitbit device overestimated the daily step count and underestimated HRV in both groups. While RHR and RR were overestimated in healthy controls, no difference was observed in patients with COPD. Oxygen saturation was overestimated in patients with COPD. The Fitbit Charge 4 detected significant differences in daily step count, RHR, and RR between patients with COPD and healthy controls, similar to those identified by the reference devices, supporting known-groups validity.
Although the Fitbit Charge 4 shows mainly moderate to good agreement, measures of clinical parameters deviated from the reference devices, indicating that monitoring patients remotely and interpreting parameters requires caution. Differences in clinical parameters between patients with COPD and healthy controls that were measured by the reference devices were all detected by the Fitbit Charge 4.
基于消费者的可穿戴设备越来越受欢迎，为远程跟踪个人的临床参数提供了机会。然而，关于其标准和已知组有效性的文献却很少。
本研究旨在评估 Fitbit Charge 4（一款腕戴式消费者可穿戴设备）在比利时的自由生活条件下测量慢性阻塞性肺疾病（COPD）患者和健康对照者的临床参数（即日常步数、静息心率[RHR]、心率变异性[HRV]、呼吸率[RR]和血氧饱和度）的有效性，将其与医疗级设备进行比较。
参与者佩戴 Fitbit Charge 4 并同时使用三种医疗级设备：（1）Dynaport MoveMonitor 佩戴 7 天，记录每日步数；（2）Polar H10 佩戴 5 天，记录 RHR、HRV 和 RR；（3）Nonin WristOX2 3150 佩戴 4 晚，记录血氧饱和度。通过研究 Fitbit Charge 4 与相应参考设备的日常测量值之间的一致性，评估标准有效性。通过比较 COPD 患者和健康对照组来评估已知组有效性。
30 名 COPD 患者和 25 名年龄和性别匹配的健康对照组的数据表明，Fitbit Charge 4 与相应参考设备在测量日常步数（组内相关系数[ICC2,1]=0.79 和 ICC2,1=0.85）、RHR（ICC2,1=0.80 和 ICC2,1=0.79）和 RR（ICC2,1=0.84 和 ICC2,1=0.77）方面具有良好的一致性。HRV 的一致性为中度（健康对照组：ICC2,1=0.69）到强（COPD：ICC2,1=0.87）。在 COPD 患者中测量血氧饱和度的一致性较差（ICC2,1=0.32）。Fitbit 设备高估了两组的日常步数并低估了 HRV。虽然健康对照组的 RHR 和 RR 被高估，但 COPD 患者中没有观察到差异。在 COPD 患者中，血氧饱和度被高估。Fitbit Charge 4 检测到 COPD 患者和健康对照组在日常步数、RHR 和 RR 方面存在显著差异，与参考设备识别的结果相似，支持了已知组有效性。
虽然 Fitbit Charge 4 主要显示出中等至良好的一致性，但临床参数的测量值与参考设备存在差异，这表明远程监测患者和解释参数需要谨慎。参考设备测量的 COPD 患者和健康对照组之间的临床参数差异均被 Fitbit Charge 4 检测到。
