Identification of undiagnosed atrial fibrillation using a machine learning risk prediction algorithm and diagnostic testing (PULsE-AI) in primary care: cost-effectiveness of a screening strategy evaluated in a randomized controlled trial in England

Figures & data

Figure 1. PULsE-AI trial schematic.

Abbreviations: AF, atrial fibrillation; ECG, electrocardiogram.

Figure 2. Screening decision tree.

Abbreviation: AF, atrial fibrillation.

¹Public Health England, 2020. Atrial fibrillation estimates for local populations. https://www.gov.uk/government/publications/atrial-fibrillation-prevalence-estimates-for-local-populations.

Figure 3. Diagnostic and treatment pathway for the screening strategy.

Abbreviations: AF, atrial fibrillation; DOAC, direct oral anticoagulant; EGC, electrocardiogram.

Figure 4. Markov model flow diagram.

Abbreviations: AF, atrial fibrillation; ICH, intracranial hemorrhage; MI, myocardial infarction.

Table 1. Overview of screening costs.

Activity	Proportion of individuals in the intervention arm incurring screening costs	Cost per individual (£)^24
Invitation for screening
Initial screening invitation (posted letter)	100%	1.48
Reminder letter (posted letter)	45%	1.48
Screening − 12-lead ECG
12-lead ECG*	100%	11.92
Cardiologist^^	100%	2.33
Screening – KardiaMobile ECG
Device cost§	100%	19.80
Training for individual*	100%	11.92
Pre-paid envelope for device return	100%	5.00
Cardiologist review^†	100%	9.32

Abbreviation: ECG, echocardiogram.

*Assumes 20 min of nurse time.

^{^}Assumes a 1-min interpretation by a cardiologist.

^§Assumes one device for every five individuals identified as high risk.

^†Assumes a 4-min interpretation by a cardiologist.

Table 2. Estimated population-level atrial fibrillation diagnoses and clinical events based on the PULsE-AI trial screening strategy compared with routine care only.

	PULsE-AI trial screening strategy	Routine care only
Diagnosed through screening intervention	45,493	0
Other diagnoses in first 6 months	6,342	7,598
Diagnosed during lifetime	152,715	182,948
Total diagnosed	204,550	190,546
Total never diagnosed	70,739	84,743
Total clinical events	332,752	333,249

N in each arm is 3,303,468 and based on the estimate number of individuals in the UK ≥ 30 years of age and at high risk of undiagnosed atrial fibrillation.

Table 3. Cost-effectiveness of the PULsE-AI trial screening strategy.

	PULsE-AI trial screening strategy		Routine care only		Incremental
	Patient-level	Population-level	Patient-level	Population-level	Patient-level	Population-level
Costs
Screening	£11	£37,158,702	£0	£0	–	–
Treatment	£413	£1,362,911,977	£346	£1,143,278,923	–	–
Events	£1,562	£5,158,553,483	£1,542	£5,093,145,162	–	–
Total	£1,985	£6,558,624,163	£1,888	£6,236,424,085	–	–
QALYs
Individuals with AF diagnosed through screening	0.15	510,364	0.02	66,091	–	–
Individuals with AF not diagnosed through screening	0.56	1,836,665	0.67	2,200,268	–	–
Individuals without AF	11.86	39,188,892	11.86	39,188,892	–	–
Total	12.57	41,535,921	12.55	41,455,252	–	–
Cost-effectiveness
Incremental costs	–	–	–	–	£98	£322,200,078
Incremental QALYs	–	–	–	–	0.02	80,669
ICER (£/QALY)	–	–	–	–	£3,994

N in each arm (for population-level) is 3,303,468 and based on the estimate number of individuals in the UK ≥ 30 years of age and at high risk of undiagnosed atrial fibrillation.

National Institute for Health Research. Clinical Research Network Industry Costing Template (Primary Care) version October 2018. v1.32.

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Data availability statement

Deidentified individual participant data that underlie the results reported in this article and the study protocol and statistical analysis plan will be made available upon reasonable request to the corresponding author.