Abstract：
In the era of digital health information technology, there has been a proliferation of devices that collect patient-generated health data (PGHD), including consumer blood pressure (BP) monitors. Despite their widespread use, it remains unclear whether such devices can improve health outcomes.
We performed a systematic review of the literature on consumer BP monitors that collect PGHD for managing hypertension to summarize their clinical impact on health and surrogate outcomes. We focused particularly on studies designed to measure the specific effect of using a BP monitor independent of cointerventions. We have also summarized the process and consumer experience outcomes.
An information specialist searched PubMed, MEDLINE, and Embase for controlled studies on consumer BP monitors published up to May 12, 2020. We assessed the risk of bias using an adapted 9-item appraisal tool and performed a narrative synthesis of the results.
We identified 41 different types of BP monitors used in 49 studies included for review. Device engineers judged that 38 (92%) of those devices were similar to the currently available consumer BP monitors. The median sample size was 222 (IQR 101-416) participants, and the median length of follow-up was 6 (IQR 3-12) months. Of the included studies, 18 (36%) were designed to isolate the clinical effects of BP monitors; 6 of the 18 (33%) studies evaluated health outcomes (eg, mortality, hospitalizations, and quality of life), and data on those outcomes were unclear. The lack of clarity was due to low event rates, short follow-up duration, and risk of bias. All 18 studies that isolated the effect of BP monitors measured both systolic and diastolic BP and generally demonstrated a decrease of 2 to 4 mm Hg in systolic BP and 1 to 3 mm Hg in diastolic BP compared with non-BP monitor groups. Adherence to using consumer BP monitors ranged from 38% to 89%, and ease of use and satisfaction ratings were generally high. Adverse events were infrequent, but there were a few technical problems with devices (eg, incorrect device alerts).
Overall, BP monitors offer small benefits in terms of BP reduction; however, the health impact of these devices continues to remain unclear. Future studies are needed to examine the effectiveness of BP monitors that transmit data to health care providers. Additional data from implementation studies may help determine which components are critical for sustained BP improvement, which in turn may improve prescription decisions by clinicians and coverage decisions by policy makers.
We performed a systematic review of the literature on consumer BP monitors that collect PGHD for managing hypertension to summarize their clinical impact on health and surrogate outcomes. We focused particularly on studies designed to measure the specific effect of using a BP monitor independent of cointerventions. We have also summarized the process and consumer experience outcomes.
An information specialist searched PubMed, MEDLINE, and Embase for controlled studies on consumer BP monitors published up to May 12, 2020. We assessed the risk of bias using an adapted 9-item appraisal tool and performed a narrative synthesis of the results.
We identified 41 different types of BP monitors used in 49 studies included for review. Device engineers judged that 38 (92%) of those devices were similar to the currently available consumer BP monitors. The median sample size was 222 (IQR 101-416) participants, and the median length of follow-up was 6 (IQR 3-12) months. Of the included studies, 18 (36%) were designed to isolate the clinical effects of BP monitors; 6 of the 18 (33%) studies evaluated health outcomes (eg, mortality, hospitalizations, and quality of life), and data on those outcomes were unclear. The lack of clarity was due to low event rates, short follow-up duration, and risk of bias. All 18 studies that isolated the effect of BP monitors measured both systolic and diastolic BP and generally demonstrated a decrease of 2 to 4 mm Hg in systolic BP and 1 to 3 mm Hg in diastolic BP compared with non-BP monitor groups. Adherence to using consumer BP monitors ranged from 38% to 89%, and ease of use and satisfaction ratings were generally high. Adverse events were infrequent, but there were a few technical problems with devices (eg, incorrect device alerts).
Overall, BP monitors offer small benefits in terms of BP reduction; however, the health impact of these devices continues to remain unclear. Future studies are needed to examine the effectiveness of BP monitors that transmit data to health care providers. Additional data from implementation studies may help determine which components are critical for sustained BP improvement, which in turn may improve prescription decisions by clinicians and coverage decisions by policy makers.
摘要：
在数字健康信息技术时代,收集患者生成的健康数据(PGHD)的设备激增，包括消费者血压（BP）监测仪。尽管它们广泛使用，目前尚不清楚此类设备是否能改善健康结果.
我们对收集PGHD治疗高血压的消费者BP监测仪的文献进行了系统综述，以总结其对健康和替代结局的临床影响。我们特别关注旨在测量使用独立于联合干预的BP监测仪的具体效果的研究。我们还总结了过程和消费者体验结果。
一位信息专家搜索了PubMed,MEDLINE,和Embase对消费者BP监测仪的对照研究发表于2020年5月12日。我们使用经过调整的9项评估工具评估了偏差的风险，并对结果进行了叙述性综合。
我们确定了用于49项研究的41种不同类型的BP监测仪。设备工程师判断，这些设备中有38台（92％）与当前可用的消费者BP监视器相似。样本量中位数为222(IQR101-416)名参与者，中位随访时间为6个月（IQR3-12个月）。在纳入的研究中，18项(36%)旨在隔离BP监测仪的临床效果；18项(33%)研究中有6项评估了健康结果(例如，死亡率,住院治疗,和生活质量)，这些结局的数据尚不清楚.缺乏清晰度是由于事件发生率低，随访时间短，和偏见的风险。分离BP监测器作用的所有18项研究均测量了收缩压和舒张压，并且与非BP监测器组相比，收缩压BP降低了2至4mmHg，舒张压降低了1至3mmHg。坚持使用消费者BP监测仪的比例从38%到89%，易用性和满意度评级普遍较高。不良事件很少发生，但是设备存在一些技术问题(例如，不正确的设备警报)。
总的来说，BP监测仪在降低BP方面的好处很小；然而，这些设备对健康的影响仍不清楚.需要进行未来的研究来检查将数据传输给医疗保健提供者的BP监测器的有效性。实施研究的其他数据可能有助于确定哪些组件对于持续的BP改善至关重要，这反过来可能会改善临床医生的处方决策和政策制定者的覆盖决策。
我们对收集PGHD治疗高血压的消费者BP监测仪的文献进行了系统综述，以总结其对健康和替代结局的临床影响。我们特别关注旨在测量使用独立于联合干预的BP监测仪的具体效果的研究。我们还总结了过程和消费者体验结果。
一位信息专家搜索了PubMed,MEDLINE,和Embase对消费者BP监测仪的对照研究发表于2020年5月12日。我们使用经过调整的9项评估工具评估了偏差的风险，并对结果进行了叙述性综合。
我们确定了用于49项研究的41种不同类型的BP监测仪。设备工程师判断，这些设备中有38台（92％）与当前可用的消费者BP监视器相似。样本量中位数为222(IQR101-416)名参与者，中位随访时间为6个月（IQR3-12个月）。在纳入的研究中，18项(36%)旨在隔离BP监测仪的临床效果；18项(33%)研究中有6项评估了健康结果(例如，死亡率,住院治疗,和生活质量)，这些结局的数据尚不清楚.缺乏清晰度是由于事件发生率低，随访时间短，和偏见的风险。分离BP监测器作用的所有18项研究均测量了收缩压和舒张压，并且与非BP监测器组相比，收缩压BP降低了2至4mmHg，舒张压降低了1至3mmHg。坚持使用消费者BP监测仪的比例从38%到89%，易用性和满意度评级普遍较高。不良事件很少发生，但是设备存在一些技术问题(例如，不正确的设备警报)。
总的来说，BP监测仪在降低BP方面的好处很小；然而，这些设备对健康的影响仍不清楚.需要进行未来的研究来检查将数据传输给医疗保健提供者的BP监测器的有效性。实施研究的其他数据可能有助于确定哪些组件对于持续的BP改善至关重要，这反过来可能会改善临床医生的处方决策和政策制定者的覆盖决策。
