Background: Biometric monitoring devices (BMDs) are wearable or environmental trackers and devices with embedded sensors that can remotely collect high-frequency objective data on patients’ physiological, biological, behavioral, and environmental contexts (for example, fitness trackers with accelerometer). The real-world effectiveness of interventions using biometric monitoring devices depends on patients’ perceptions of these interventions. Objective: We aimed to systematically review whether and how recent randomized controlled trials (RCTs) evaluating interventions using BMDs assessed patients’ perceptions toward the intervention. Methods: We systematically searched PubMed (MEDLINE) from January 1, 2017, to December 31, 2018, for RCTs evaluating interventions using BMDs. Two independent investigators extracted the following information: (1) whether the RCT collected information on patient perceptions toward the intervention using BMDs and (2) if so, what precisely was collected, based on items from questionnaires used and/or themes and subthemes identified from qualitative assessments. The two investigators then synthesized their findings in a schema of patient perceptions of interventions using BMDs. Results: A total of 58 RCTs including 10,071 participants were included in the review (the median number of randomized participants was 60, IQR 37-133). BMDs used in interventions were accelerometers/pedometers (n=35, 60%), electrochemical biosensors (eg, continuous glucose monitoring; n=18, 31%), or ecological momentary assessment devices (eg, carbon monoxide monitors for smoking cessation; n=5, 9%). Overall, 26 (45%) trials collected information on patient perceptions toward the intervention using BMDs and allowed the identification of 76 unique aspects of patient perceptions that could affect the uptake of these interventions (eg, relevance of the information provided, alarm burden, privacy and data handling, impact on health outcomes, independence, interference with daily life). Patient perceptions were unevenly collected in trials. For example, only 5% (n=3) of trials assessed how patients felt about privacy and data handling aspects of the intervention using BMDs. Conclusions: Our review showed that less than half of RCTs evaluating interventions using BMDs assessed patients’ perceptions toward interventions using BMDs. Trials that did assess perceptions often only assessed a fraction of them. This limits the extrapolation of the results of these RCTs to the real world. We thus provide a comprehensive schema of aspects of patient perceptions that may affect the uptake of interventions using BMDs and which should be considered in future trials. Trial Registration: PROSPERO CRD42018115522; https://tinyurl.com/y5h8fjgx

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中文翻译：

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使用生物特征监测设备识别可能影响干预措施采用的患者知觉：随机对照试验的系统评价。

背景：生物识别监视设备（BMD）是可穿戴或环境跟踪器，以及带有嵌入式传感器的设备，可以远程收集有关患者的生理，生物学，行为和环境情况的高频客观数据（例如，带有加速度计的健身跟踪器）。使用生物特征监测设备进行干预的真实效果取决于患者对这些干预的理解。目的：我们旨在系统地审查是否使用BMD评估最近的随机对照试验（RCT）以及如何评估患者对干预的看法。方法：我们系统搜索了2017年1月1日至2018年12月31日的PubMed（MEDLINE），以评估使用BMD进行干预的RCT。两名独立调查员提取了以下信息：（1）RCT是否收集了有关使用BMD进行干预的患者认知的信息；（2）是否收集了基于所使用问卷的项目和/或从定性评估中确定的主题和子主题的精确信息。然后，两位研究者在患者对使用BMD进行干预的看法中总结了他们的发现。结果：共有58项RCT，包括10,071名参与者（随机参与者的中位数为60，IQR 37-133）。干预措施中使用的BMD是加速度计/计步器（n = 35，60％），电化学生物传感器（例如，连续葡萄糖监测； n = 18，31％）或生态瞬时评估装置（例如，用于戒烟的一氧化碳监测器； n = 5，9％）。总体，26项试验（45％）收集了有关使用BMD进行干预的患者感知信息，并确定了可能影响这些干预措施采用的76个患者感知独特方面（例如，所提供信息的相关性，警报负担，隐私和数据处理，对健康结果的影响，独立性，对日常生活的干扰）。在试验中，患者的看法收集不均。例如，只有5％（n = 3）的试验评估了患者对使用BMD进行干预的隐私和数据处理方面的看法。结论：我们的审查表明，只有不到一半的RCT使用BMD评估干预措施，评估了患者对使用BMD干预的看法。确实评估了感知的试验通常仅评估了其中的一小部分。这限制了将这些RCT的结果外推到现实世界。因此，我们提供了可能影响使用BMD进行干预的患者感知方面的全面方案，应在以后的试验中予以考虑。试用注册：PROSPERO CRD42018115522；https://tinyurl.com/y5h8fjgx

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