可穿戴设备用于心房颤动筛查的有效性系统评价

高晨曦; 陈清勇

doi:10.16766/j.cnki.issn.1674-4152.002565

可穿戴设备用于心房颤动筛查的有效性系统评价

doi: 10.16766/j.cnki.issn.1674-4152.002565

高晨曦¹,
陈清勇^2, ,

1.
四川大学华西医院全科医学科，四川成都 610041
2.
四川大学华西医院心脏内科

基金项目:

国家重点研发计划项目 2019YFC1709003

详细信息

通讯作者:
陈清勇，E-mail：tsingsion@qq.com

中图分类号: R541.75 R443.8
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- 文章访问数: 185
- HTML全文浏览量: 151
- PDF下载量: 7
- 被引次数: 0
出版历程
- 收稿日期: 2021-12-15
- 网络出版日期: 2022-09-23

Systematic Review on the Efficacy of Atrial Fibrillation Screening Using Wearable Devices

GAO Chen-xi¹,
CHEN Qing-yong^{2
, ,}

1.
Department of General Practice, West-China Hospital, Sichuan University, Chengdu, Sichuan 610041, China

摘要

摘要: 目的采用系统评价的方法，分析随机对照试验(RCT)研究中不同种类可穿戴设备用于房颤筛查的实际检出率，为能显著有效提升房颤检出率设备的临床应用提供综合证据。方法检索MEDLINE(PubMed)、Ovid、Clinical Trials、万方医学网和中国知网数据库，筛查出建库至2021年10月30日所有符合本文主题的RCT论文，按照系统评价和meta分析的优先报告条目，提取出与房颤检出率相关的数据，进行归纳整理分析。结果纳入RCT原始论文11篇，合计意向受试人数41 565人。有5个RCT均证明，连续心电图(cECG)技术类的胸贴与常规检测手段相比显著地提升了房颤的检出率。在6个关于手持式间歇性ECG检测设备的RCT研究中，只有2个证实了房颤检出率的显著提升。结论 cECG胸贴比常规检测手段可以更有效地筛查出房颤。手持式间歇ECG检测设备的房颤筛查效果尚不一致，有待进一步研究。
- 可穿戴设备 /
- 心房颤动 /
- 筛查 /
- 随机对照试验 /
- 系统评价
Abstract: Objective To carry out a systematic review of randomised controlled trial (RCT) studies on atrial fibrillation (AF) detection rates by wearable devices and provide the integrated evidence in supporting the clinical application of wearable devices that have been shown to be significantly effective in enhancing AF detection rates. Methods MEDLINE (PubMed), Ovid, Clinical Trials, Wanfang Medical Network and CNKI databases were searched for RCT studies on AF screening efficacy using wearable devices, published from establishment of the databases to October 30, 2021. The data related to AF detection rates were extracted, summarised and analysed according to "Preferred Reporting Items for Systematic Reviews and Meta-Analyses". Results A total of 11 RCT papers with a total of 41 565 intention-to-screen participants were identified. On continuous ECG(cECG) patches, 5 RCTs showed significantly higher AF detection rates compared with conventional detection methods. Of 6 RCT studies on handheld intermittent ECG detection devices, only 2 showed significantly higher AF detection rates compared with conventional methods. Conclusion AF can be more effectively screened using continuous cECG-based wearable devices compared with conventional detection methods. The effect of handheld intermittent ECG devices on AF screening was inconsistent, and further research is needed.
- Wearable devices /
- Atrial fibrillation /
- Screening /
- Randomised controlled trials /
- Systematic review

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图 1 文献筛选流程及结果

注：^a具体分为PubMed(n=1 506)、Medline(n=1 328)、Ovid(n=2 579)、Clinical Trials(n=5)、万方医学网(n=253)、中国知网数据库(n=476)。

Figure 1. Literature screening process and results

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表 1 可穿戴设备用于房颤筛查的RCT研究汇总

Table 1. Summary of RCT studies on AF screening using wearable devices

首位作者，发表年，国家	筛查方法干预组vs. 对照组	研究对象；人数，平均年龄；随访时间	可穿戴设备监测持续时间	干预组房颤判定标准	房颤检出率(干预组/对照组, %)	房颤检出率相对比	检出率比较的P值
KAURA A, 2019, 英国^[6]	Zio Patch vs. 24-h Holter	过去72 h内被诊断为非腔隙性卒中或TIA的患者；干预组43人，70.7岁；常规检测手段对照组47人, 70.0岁；随访90 d	连续14 d	≥30 s房颤	16.3/2.1	7.76	0.03
OKUBO Y, 2022, 日本^[7]	myBeat vs. 24-h Holter	≥65岁合并房颤高危因素、无房颤既往病史的出院患者；干预组150人，73.9岁；14 d内常规检测手段对照组150人, 72.9岁	连续5 d	≥30 s房颤	10.7/4.7	2.28	0.04
HA A C T, 2021，加拿大^[8]	SEEQ或CardioSTAT vs. 12导ECG或24-h Holter	心脏外科术后出院患者，术前无房颤、房扑病史；干预组163人，67.5岁；常规检测手段对照组173人，67.4岁；30 d随访	连续28~30 d	累计≥6 min的房颤或房扑	19.6/1.7	11.53	< 0.01
STEINHUBL S R, 2018, 美国^[9]	Zio patch vs. 常规12导ECG	≥75岁、或≥55岁男性或≥65岁女性合并房颤高危因素、无房颤既往病史的健康保险参加者；干预组1 366人，73.5岁；常规检查组1 293人，73.1岁；4个月随访	开始时和3个月时各连续14 d	≥30 s的房颤或心扑	3.9/0.9	4.33	< 0.05
GLADSTONE D J，2021，加拿大^[10]	Zio Patch vs. 12导ECG	≥75岁合并高血压、无房颤既往病史的社区居民；干预组434人，79.8岁；常规检测手段对照组422人，80.1岁；6个月随访	开始时和3个月时各连续14 d	累计≥5 min的房颤或房扑	5.3/0.5	10.60	< 0.01
HALCOX J P J, 2017, 英国^[11]	AliveCor Heart Monitor vs. 24-h Holter	≥65岁无房颤病史、CHADS-VASc≥2、无既往房颤病史的患者；干预组500人，72.6岁；常规检测手段对照组501人，72.6岁；12个月随访	每周2次检测，各30 s；共12个月	≥30 s房颤	3.8/1.0	3.80	< 0.05
KOH K T, 2021, 马来西亚^[12]	AliveCor KardiaMobile vs. 24-h Holter	≥55岁、过去12个月有缺血性卒中或TIA、无既往房颤病史的患者；干预组105人，65.3岁；常规检测手段对照组98人，65.8岁；3个月随访	每天3次检测，各30 s；共30 d	≥30 s房颤	9.5/2.0	4.75	0.02
GOLDENTHAL I L, 2019, 美国^[13]	AliveCor KardiaMobile vs. 24-h Holter	消融或复律后的患者；干预组115人，61岁；常规检测手段对照组118人，61岁；6个月随访	平均每天1次检测(30 s)；共6个月	≥30 s房颤	50.4/41.5	1.21	0.17
MANCINETTI M, 2021, 瑞典^[14]	Zenicor单导ECG检测器vs. 常规12导ECG	≥18岁无房颤病史的普通内科住院患者；干预组381人，66.2岁；常规检测手段对照组423人，64.6岁；6 d住院期间观察	每天2次检测，各30 s，共6 d	≥30 s房颤	1.8/0.7	2.57	0.20
KAASENBROOD F, 2020，荷兰^[15]	MyDiagnostick单导ECG检测器vs. 常规12导ECG	全科诊所中≥65岁无房颤病史的常规患者；干预组8 581人，74.3岁；常规检测手段对照组8 526人，74.5岁；随访1年	1年内在诊所就诊时的机会性筛查	≥30 s房颤	1.43/1.37	1.04	0.73
UITTENBOGAART S B, 2020, 荷兰^[16]	MyDiagnostick单导ECG检测器vs. 常规12导ECG	全科诊所中≥65岁无房颤病史的常规患者；干预组8 874人，75.2岁；常规检测手段对照组9 102人，75.0岁；随访1年	1年内在诊所就诊时的机会性筛查	≥30 s房颤	1.6/1.5	1.06	0.60

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表 2 根据RoB 2工具对随机临床试验进行偏倚风险评价

Table 2. Risk of bias assessment of randomized clinical trials according to RoB 2.0

第一作者	随机过程的偏倚	偏离既定干预的偏倚	结局数据缺失的偏倚	结局测量的偏倚	结果选择性报道的偏倚	整体偏倚^a
KAURA A^[6]	L	M	M	L	L	M
OKUBO Y^[7]	M	M	L	L	L	M
HA A C T^[8]	L	M	L	L	L	M
STEINHUBL S R^[9]	L	M	L	L	L	M
GLADSTONE D J^[10]	L	M	L	L	L	M
HALCOX J P J^[11]	L	M	L	L	L	M
KOH K T^[12]	L	M	L	L	L	M
GOLDENTHAL I L^[13]	L	M	L	L	L	M
MANCINETTI M^[14]	L	M	L	L	L	M
KAASENBROOD F^[15]	L	M	H	L	L	H
UITTENBOGAART S B^[16]	L	M	H	L	L	H
注：L为低风险，M为可能存在风险，H为高风险。^a表示如果5个模块中任一个模块被评为“高风险”，或多个模块被评为“可能存在风险”且对研究结果的可信度有较大影响，则整体评价为高风险；如果5个模块的偏倚评估均为低风险，则总体偏倚风险评价为低风险；如果5个模块均未被评为高风险，但有任一模块被评为可能存在风险，则整体评价为可能存在风险。

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参考文献(17)

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