Mobile Health Versus Standard Care for the Detection of Atrial Fibrillation: a Systematic Review (Preprint)
BACKGROUND 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 ECG devices, have been introduced to the worldwide consumer market over the past decade. Studies have, among other factors, assessed the usability of these devices for the detection of AF. OBJECTIVE To conduct a systematic review of diagnostic detection rate of AF by mHealth devices, compared with standard follow-up. METHODS Setting: Clinical or outpatient care. Participants: Patients over the age of 16 with an indication for ECG follow-up. Intervention: The use of trans-telephonic ECG recordings or an mHealth device, defined as a novel device for the diagnosis of rhythm disturbances, which is either a handheld electronic device or a patch-like device that is installed on the patient’s chest. Main outcome measures: The odds-ratio (OR) of AF detection, comparing mHealth devices to standard care. Review methods: Two reviewers screened the search results and extracted data, as well as performing the risk of bias assessment. A heterogeneity analysis was performed, a Forest plot was made to summarize the results of the individual studies, and an Albatross plot was made to allow the P-values to be interpreted in the context of the study sample size. RESULTS A total of 3384 articles were identified after a database search. Fourteen studies with a total of 4617 study participants were selected for qualitative synthesis, consisting of eight cohort studies, four randomized-controlled trials (RCT’s) and two case-control studies. Between study populations, 42 to 87% were male; mean age varied from 44 to 73 years. Nine studies used a handheld single-lead ECG device for a duration of 28 days to 1 year, five studies used a body patch for a duration of 1 to 14 days. Standard follow-up consisted of Holter monitoring in 12 studies, while one study used implantable loop recorders and the final study used a 12-lead ECG as standard follow-up. 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 RCT’s showing statistically significant improvements of AF detection (OR 1.54 – 19.16). The statistical heterogeneity between studies was considerable, with a Q of 34.1 and an I2 of 61.9, and therefore it was decided to not pool the results into a meta-analysis. CONCLUSIONS Although the results of 13 out of 14 studies support the effectiveness of mHealth interventions compared with standard care, with the remainder study showing equal effectiveness, it cannot be concluded for those interventions to be more effective than standard follow-up as due to considerable clinical and statistical heterogeneity, study results could not be pooled. 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. Yet, clinicians must beware of overdiagnosis of AF, as it is not yet clear when an mHealth-detected episode of AF has to be deemed significant.