Leiden University Medical Center, Leiden, Netherlands.
JMIR Mhealth Uhealth. 2021 Apr 28;9(4):e26161. doi: 10.2196/26161.
Atrial fibrillation (AF) is the most common arrhythmia, and its prevalence is increasing. Early diagnosis is important to reduce the risk of stroke. Mobile health (mHealth) devices, such as single-lead electrocardiogram (ECG) devices, have been introduced to the worldwide consumer market over the past decade. Recent studies have assessed the usability of these devices for detection of AF, but it remains unclear if the use of mHealth devices leads to a higher AF detection rate.
The goal of the research was to conduct a systematic review of the diagnostic detection rate of AF by mHealth devices compared with traditional outpatient follow-up. Study participants were aged 16 years or older and had an increased risk for an arrhythmia and an indication for ECG follow-up-for instance, after catheter ablation or presentation to the emergency department with palpitations or (near) syncope. The intervention was the use of an mHealth device, defined as a novel device for the diagnosis of rhythm disturbances, either a handheld electronic device or a patch-like device worn on the patient's chest. Control was standard (traditional) outpatient care, defined as follow-up via general practitioner or regular outpatient clinic visits with a standard 12-lead ECG or Holter monitoring. The main outcome measures were the odds ratio (OR) of AF detection rates.
Two reviewers screened the search results, extracted data, and performed a risk of bias assessment. A heterogeneity analysis was performed, forest plot made to summarize the results of the individual studies, and albatross plot made to allow the P values to be interpreted in the context of the study sample size.
A total of 3384 articles were identified after a database search, and 14 studies with a 4617 study participants were selected. All studies but one showed a higher AF detection rate in the mHealth group compared with the control group (OR 1.00-35.71), with all RCTs showing statistically significant increases of AF detection (OR 1.54-19.16). Statistical heterogeneity between studies was considerable, with a Q of 34.1 and an I of 61.9, and therefore it was decided to not pool the results into a meta-analysis.
Although the results of 13 of 14 studies support the effectiveness of mHealth interventions compared with standard care, study results could not be pooled due to considerable clinical and statistical heterogeneity. However, smartphone-connectable ECG devices provide patients with the ability to document a rhythm disturbance more easily than with standard care, which may increase empowerment and engagement with regard to their illness. Clinicians must beware of overdiagnosis of AF, as it is not yet clear when an mHealth-detected episode of AF must be deemed significant.
心房颤动（AF）是最常见的心律失常，其发病率正在上升。早期诊断对于降低中风风险很重要。移动医疗（mHealth）设备，如单导联心电图（ECG）设备，在过去十年已推向全球消费者市场。最近的研究评估了这些设备用于检测 AF 的可用性，但尚不清楚使用 mHealth 设备是否会导致更高的 AF 检测率。
本研究旨在对 mHealth 设备与传统门诊随访相比诊断检测 AF 的诊断检测率进行系统评价。研究参与者年龄在 16 岁及以上，且存在心律失常风险并需要进行心电图随访，例如导管消融后或因心悸或（近乎）晕厥就诊急诊科。干预措施是使用 mHealth 设备，定义为用于诊断节律障碍的新型设备，为手持式电子设备或贴在患者胸部的贴片式设备。对照组为标准（传统）门诊护理，定义为通过全科医生或定期门诊就诊，使用标准 12 导联心电图或动态心电图监测。主要结局指标为 AF 检测率的优势比（OR）。
两名审查员筛选了搜索结果，提取了数据，并进行了偏倚风险评估。进行了异质性分析，制作了森林图以总结各个研究的结果，并制作了信天翁图以允许根据研究样本量解释 P 值。
数据库搜索后共确定了 3384 篇文章，最终纳入了 14 项研究，共 4617 名参与者。所有研究（除了一项研究）均显示 mHealth 组的 AF 检测率高于对照组（OR 1.00-35.71），所有 RCT 均显示 AF 检测率有统计学意义的增加（OR 1.54-19.16）。研究之间存在相当大的统计学异质性，Q 值为 34.1，I 为 61.9，因此决定不将结果进行荟萃分析。
尽管 14 项研究中的 13 项研究结果支持 mHealth 干预措施与标准护理相比的有效性，但由于临床和统计学异质性较大，因此无法将研究结果进行汇总。然而，与标准护理相比，智能手机连接心电图设备使患者更容易记录心律失常，这可能会增加他们对疾病的掌控感和参与度。临床医生必须注意 AF 的过度诊断，因为目前尚不清楚何时应将 mHealth 检测到的 AF 发作视为重要。
