Opportunistic screening versus usual care for detection of atrial fibrillation in primary care: cluster randomised controlled trial

Abstract

Objective: To investigate whether opportunistic screening in primary care increases the detection of atrial fibrillation compared with usual care.

Design: Cluster randomised controlled trial.

Setting: 47 intention-to-screen and 49 usual care primary care practices in the Netherlands, not blinded for allocation; the study was carried out from September 2015 to August 2018.

Participants: In each practice, a fixed sample of 200 eligible patients, aged 65 or older, with no known history of atrial fibrillation in the electronic medical record system, were randomly selected. In the intention-to-screen group, 9218 patients eligible for screening were included, 55.0% women, mean age 75.2 years. In the usual care group, 9526 patients were eligible for screening, 54.3% women, mean age 75.0 years.

Interventions: Opportunistic screening (that is, screening in patients visiting their general practice) consisted of three index tests: pulse palpation, electronic blood pressure measurement with an atrial fibrillation algorithm, and electrocardiography (ECG) with a handheld single lead electrocardiographic device. The reference standard was 12 lead ECG, performed in patients with at least one positive index test and in a sample of patients (10%) with three negative tests. If 12 lead ECG showed no atrial fibrillation, patients were invited for more screening by continuous monitoring with a Holter electrocardiograph for two weeks.

Main outcome measures: Difference in the detection rate of newly diagnosed atrial fibrillation over one year in intention-to-screen versus usual care practices.

Results: Follow-up was complete for 8874 patients in the intention-to-screen practices and for 9102 patients in the usual care practices. 144 (1.62%) new diagnoses of atrial fibrillation in the intention-to-screen group versus 139 (1.53%) in the usual care group were found (adjusted odds ratio 1.06 (95% confidence interval 0.84 to 1.35)). Of 9218 eligible patients in the intention-to-screen group, 4106 (44.5%) participated in the screening protocol. In these patients, 12 lead ECG detected newly diagnosed atrial fibrillation in 26 patients (0.63%). In the 266 patients who continued with Holter monitoring, four more diagnoses of atrial fibrillation were found.

Conclusions: Opportunistic screening for atrial fibrillation in primary care patients, aged 65 and over, did not increase the detection rate of atrial fibrillation, which implies that opportunistic screening for atrial fibrillation is not useful in this setting.

Trial registration: Netherlands Trial Register No NL4776 (old NTR4914).

Fig 1

Flowchart of enrolment of primary care practices (clusters) and patients in the study

Fig 2

Flowchart of the results of the screening intervention (n=4106). In 488 patients, electrocardiography (ECG) was required according to the protocol because the patient had at least one positive index test. An electrocardiogram was missing in 40 patients because of technical or organisational difficulties, or refusal of the patient. Of 3618 patients with three negative index tests, 294 were randomised to 12 lead ECG. Of 294 (with three negative index tests) and 422 (with at least one positive index test) patients who had a negative electrocardiogram, 266 continued with Holter monitoring for two weeks