Erschienen in:
10.11.2022 | Concise Research Report
Patient-Centered Outcomes in Clinical Trials of Wearable Devices for Atrial Fibrillation
verfasst von:
Alexander Chaitoff, MD, MPH, Jingyi Gong, MD, Joshua D. Niforatos, MD, MTS, Alexander R. Zheutlin, MD, MS
Erschienen in:
Journal of General Internal Medicine
|
Ausgabe 6/2023
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Excerpt
There is mainstream and academic debate over whether wearable technologies improve patient health.
1,2 Detecting arrhythmias is one particularly popular application of wearable devices. For example, multiple studies have shown that devices (e.g., “smart watches”) may be able to accurately diagnose atrial fibrillation.
3 However, wearable devices are not required to undergo the same types of safety and effectiveness clinical trials as do new pharmaceuticals.
4 As such, it remains unknown to what extent these devices are being studied for their ability to impact patient-oriented clinical outcomes (e.g., symptom burden or cardiovascular events) rather than surrogate outcomes (e.g., simply detecting arrhythmias). We described the outcomes assessed in registered clinical trials of wearable devices used for atrial fibrillation. …
