Digital recruitment and prevalence of screen-detected atrial fibrillation in nationwide patch-based ECG screening: the NORSCREEN randomized clinical trial
Key result
Site-less patch-based ECG screening detects undiagnosed AF in ~2% of at-risk individuals.
- NNT 52
- NNT 52
- n=50,549
Figures
Why the study?
Conventional screening modalities for AF are often constrained by considerable resource and logistical demands, leaving the effectiveness of a fully digital recruitment and patch-based screening strategy to be evaluated.
Does a fully digital, site-less patch-based ECG screening strategy detect previously undiagnosed atrial fibrillation in older adults at elevated stroke risk?
Key Points
- To evaluate the feasibility and effectiveness of a fully digital recruitment and screening strategy, determine the prevalence of screen-detected atrial fibrillation, and assess participant adherence to therapeutic recommendations.
- Digitally invited 551 555 Norwegian residents aged ≥65 years with ≥1 additional stroke risk factor, randomizing 50 549 eligible participants 1:1 to continuous patch-based screening or usual care (NCT05914883).
- Mailed a patch-based electrocardiogram sensor to screening-group participants for 7 days of site-less continuous monitoring at home, advising those diagnosed with atrial fibrillation to contact their general practitioner.
- In the screening group, 19 723 (78.1%) completed monitoring, and previously undiagnosed atrial fibrillation was identified in 382 (1.9%) participants, yielding a number needed to screen of 52.
- Screen-detected atrial fibrillation prevalence was significantly higher in men than women (2.6% [n = 276/10 695] vs. 1.2% [n = 106/9028]; P ≤ 0.001) and increased with age.
- Among the 382 participants with screen-detected atrial fibrillation, 366 (95.8%) initiated recommended anticoagulation therapy.
Study Design
Type
RCT (n=50,549)
Randomization
1:1
Structured PICO
Does a fully digital, site-less patch-based ECG screening strategy detect previously undiagnosed atrial fibrillation in older adults at elevated stroke risk?
P
Population
50,549 Norwegian adults aged ≥65 years with at least one additional stroke risk factor, randomized to digital patch-based ECG screening or usual care.
I
Intervention
Fully digital recruitment and site-less continuous patch-based ECG monitoring (ECG247 Smart Heart Sensor) at home for 7 days.
C
Comparator
Usual care (no study-specific interventions).
O
Outcome
Prevalence of previously undiagnosed screen-detected atrial fibrillation and adherence to anticoagulation recommendations.surrogate
Main Result
Number Needed to Treat: 52
Number Needed to Treat: 52
A fully digital, site-less AF screening strategy is feasible and effective, identifying undiagnosed AF in 1.9% of an at-risk population with high subsequent adherence to anticoagulation.
Limitations
- Digital recruitment strategy likely introduced selection bias towards digitally literate and healthier participants
- Reliance on self-reported health data at inclusion
- Potential for false-negative events with the ECG sensor
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“The stand-out feature of the NORSCREEN study is that they were able to fully digitize and automate all recruitment stages of the study from identification of the potential cohort, confirming eligibility, signing consent, and data entry. Integral to this was their ability to use existing national digital infrastructure, specific to Norway. Nevertheless, NORSCREEN provides food for thought about what is possible, and where technology can take us in the future to enable a national scalable and affordable AF screening programme.”
Implication
Supports digital patch screening for AF in older adults at risk; extends evidence with randomized confirmation of scalable detection and high treatment uptake.
Abstract
AIMS: Conventional screening modalities for atrial fibrillation (AF) are often constrained by considerable resource and logistical demands. The randomized controlled NORwegian atrial fibrillation self-SCREENing (NORSCREEN) trial employs a fully digital approach to recruitment and implementation. The aim of this pre-specified analysis was to evaluate the effectiveness of the fully digital recruitment and screening strategy, determine the prevalence of screen-detected AF, and assess initial adherence to therapeutic recommendations. METHODS AND RESULTS: Individuals aged ≥65 years with ≥1 additional risk factor for stroke were digitally recruited from the general Norwegian population and randomized 1:1 to screening or usual care. Exclusion criteria included prior AF, anticoagulation, implantable cardiac electronic devices, or lack of smartphone access. Participants allocated to screening were mailed a patch-based electrocardiogram sensor for site-less continuous monitoring over 7 days. Those with diagnosed AF were advised to contact their general practitioner to initiate appropriate therapy. A total of 551 555 Norwegian residents were digitally invited; of these, 139 596 (25.3%) completed the digital eligibility assessment, 74 956 (53.7%) were eligible, and 50 549 (67.4%) were randomized to screening or usual care. The median age was 75 years (inter-quartile range: 69-78), 23 445 (46.4%) were female, and the mean CHA2DS2-VA risk score was 2.6 ± 0.9. In the screening group, 19 723 (78.1%) completed the study procedures. Previously undiagnosed AF was identified in 382 (1.9%) screened participants, of whom 366 (95.8%) initiated anticoagulation therapy. CONCLUSION: The NORSCREEN trial demonstrates that fully digital, large-scale, site-less AF screening is feasible and effective in an at-risk population, identifying previously undiagnosed AF in 1.9% of screened individuals and showing high adherence to therapeutic recommendations. CLINICAL TRIAL REGISTRATION: NCT05914883.
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Cite This Study
Boskovic et al. (2026) conducted an RCT in Elevated stroke risk (n=50,549). Digital recruitment and patch-based ECG screening vs. Usual care was evaluated on Prevalence of previously undiagnosed atrial fibrillation (NNT 52). A fully digital, site-less screening strategy using a patch-based ECG sensor identified previously undiagnosed atrial fibrillation in 1.9% of screened individuals, with a number needed to screen of 52.