Research AppraisalRandomised Controlled Trial

Overdiagnosis in atrial fibrillation screening with wearables

Scandinavian journal of primary health careHaase, Christoffer Bjerre, Jensen, Alma Emilie, Modin, Frederikke Agerbo et al.1 Dec 2026DOI

Clinical Snapshot

50CEBM
Evidence: ModerateRandomised Controlled Trial

PICO Framework

P — PopulationAsymptomatic, high-risk individuals eligible for atrial fibrillation screening
I — InterventionWearable-enabled AF screening (intermittent ≥10 recordings or continuous ≥1 week)
C — ComparatorStandard care or control groups without wearable screening
O — OutcomesAF diagnoses, anticoagulant use, adverse events, and overdiagnosis estimates

Bottom Line

This hypothesis-generating analysis suggests wearable-enabled AF screening in high-risk asymptomatic patients may lead to significant overdiagnosis, with 2-3 fold increases in AF detection and doubled anticoagulant use but minimal impact on clinical outcomes. Overdiagnosis estimates range from 8-65% depending on analytical approach. While the methodology has limitations (not a formal systematic review, no quality assessment), the findings raise important concerns about uncritical adoption of consumer wearables for AF screening. The results support a cautious approach to integrating these technologies into clinical practice, emphasising the need for clear clinical pathways and patient counselling about potential harms of screening. Further high-quality RCTs with extended follow-up are needed before widespread implementation.

Evidence: Moderate

Key Findings

  • P Value: Not explicitly reported for primary outcomes

  • Effect Size: Continuous screening OR 2.84 for AF diagnosis; intermittent screening OR 1.8 (non-significant)

  • Primary Outcome: AF diagnosis rates and overdiagnosis estimates

  • Nnt Or Sensitivity: Overdiagnosis estimates 8-29% (persistent differences) or 47-65% (screening phase analysis)

  • Confidence Interval: 95% CI 1.61-5.02 for continuous screening

Clinical Application

Highly feasible given widespread availability of consumer wearables, but clinical integration pathways unclear Relevant to Australian primary care given increasing consumer wearable use; aligns with RACGP emphasis on evidence-based screening and avoiding overdiagnosis High-risk asymptomatic patients considering AF screening with consumer wearables

Abstract

PURPOSE: Wearable technologies are increasingly used to screen for atrial fibrillation (AF), often outside formal clinical pathways. While this holds promise for early detection, the impact on patient outcomes remains unclear. We aimed to examine the hypothesis whether intermittent and continuous AF screening using wearable-like technologies leads to overdiagnosis in asymptomatic, high-risk individuals. METHODS: This hypothesis-generating analysis draws on available RCTs screening asymptomatic, high-risk individuals for AF using wearable-like ECG technologies. It is not a systematic review, as the field remains too early-stage for formal evidence synthesis. Eligible studies included either intermittent (≥10 recordings) or continuous monitoring for ≥1 week, reflecting typical smartwatch use. Primary outcomes included AF diagnoses, anticoagulant use, and adverse events. Overdiagnosis was inferred when excess AF detection did not translate into improved clinical outcomes. Analyses used Mantel-Haenszel random-effects models. RESULTS: Continuous screening nearly tripled AF diagnoses (OR 2.84; 95% CI, 1.61-5.02) and doubled anticoagulant use compared to controls. Intermittent screening showed a non-significant 1.8-fold increase. Neither method significantly reduced adverse outcomes. A pooled analysis revealed a marginal reduction in negative events (OR 0.94, 95% CI 0.90-0.99). Overdiagnosis estimates varied by method, ranging from 8-29% based on persistent differences in cumulative incidence after the screening period has ended and 47-65% based on increased diagnoses and treatment during the screening phase that are not followed by improved patient-relevant outcomes. CONCLUSION: Wearable-enabled screening for AF in high-risk patients increases diagnosis and treatment without clear benefit in clinical outcomes. These findings support the hypothesis of overdiagnosis and findings highlight the need for cautious integration of consumer technologies into primary care. Further trials with extended follow-up in low-risk populations are needed to clarify when AF detection improves outcomes versus when it leads to unnecessary medicalisation and harm.

References

  1. 1.Haase, C. B., Jensen, A. E., Modin, F. A., Siersma, V., & Brodersen, J. B. (2026). Overdiagnosis in atrial fibrillation screening with wearables. Scandinavian Journal of Primary Health Care, 44(4), 1-8. https://doi.org/10.1080/02813432.2026.2656694
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