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Including inconclusive smartwatch readings in diagnostic reporting changes how accurately wearable ECGs detect AF. A prospective study published in Heart Rhythm found that real-world testing frameworks yield very different accuracy values compared with traditional validation methods.

The study involved 296 adults at a teaching hospital in Ireland who underwent ECG testing using a consumer smartwatch. Recordings were analyzed with both the native device algorithm and an AI-based neural network. Three reporting frameworks were compared: naive (excluding inconclusive results), pragmatic (counting them as incorrect), and intention-to-diagnose (allowing three attempts).

Under the naive approach, sensitivity and specificity reached 96.1% and 97.9%, while the pragmatic approach showed lower values of 78.1% and 81.0%. Under the intention-to-diagnose model, accuracy reached 92.2% sensitivity and 91.0% specificity. The AI system achieved 98.4% sensitivity and 96.6% specificity, with a 92% reduction in inconclusive outputs. Repeatability was substantial for the smartwatch (κ = 0.77) and near-perfect for AI (κ = 0.96).

These findings highlight the need to use intention-to-diagnose frameworks that include inconclusive readings and repeat testing. This approach provides a more realistic and clinically relevant measure of wearable ECG accuracy for AF detection.

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Key highlights
  • A prospective study of 296 adults evaluated three reporting frameworks for smartwatch ECG atrial fibrillation (AF) detection.
  • Inconclusive readings significantly altered diagnostic accuracy estimates.
  • AI interpretation cut inconclusive outputs by 92% and improved intention-to-diagnose accuracy to 98.4% sensitivity and 96.6% specificity.
Source

Doggart P, Fisher C, Biglarbeigi P, et al. Accounting for Inconclusive Results and Repeated Testing: A Framework for Evaluating Wearable ECG Diagnostic Performance with Application to Apple Watch and AI-Enhanced Interpretation. Heart Rhythm. Published online November 7, 2025. doi:10.1016/j.hrthm.2025.11.003

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Inconclusive Readings Reveal True Accuracy of Wearable ECGs for AF Detection
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AI analysis improves real-world reliability and reduces inconclusive smartwatch results

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