Detection of atrial fibrillation in primary care with radial pulse palpation, electronic blood pressure measurement and handheld single-lead electrocardiography: a diagnostic accuracy study.

OBJECTIVE: To determine the diagnostic accuracy of three tests-radial pulse palpation, an electronic blood pressure monitor and a handheld single-lead ECG device-for opportunistic screening for unknown atrial fibrillation (AF). DESIGN: We performed a diagnostic accuracy study in the intention-to-screen arm of a cluster randomised controlled trial aimed at opportunistic screening for AF in general practice. We performed radial pulse palpation, followed by electronic blood pressure measurement (WatchBP Home A) and handheld ECG (MyDiagnostick) in random order. If one or more index tests were positive, we performed a 12-lead ECG at shortest notice. Similarly, to limit verification bias, a random sample of patients with three negative index tests received this reference test. Additionally, we analysed the dataset using multiple imputation. We present pooled diagnostic parameters. SETTING: 47 general practices participated between September 2015 and August 2018. PARTICIPANTS: In the electronic medical record system of the participating general practices (n=47), we randomly marked 200 patients of ≥65 years without AF. When they visited the practice for any reason, we invited them to participate. Exclusion criteria were terminal illness, inability to give informed consent or visit the practice or having a pacemaker or an implantable cardioverter-defibrillator. OUTCOMES: Diagnostic accuracy of individual tests and test combinations to detect unknown AF. RESULTS: We included 4339 patients; 0.8% showed new AF. Sensitivity and specificity were 62.8% (range 43.1%-69.7%) and 91.8% (91.7%-91.8%) for radial pulse palpation, 70.0% (49.0%-80.6%) and 96.5% (96.3%-96.7%) for electronic blood pressure measurement and 90.1% (60.8%-100%) and 97.9% (97.8%-97.9%) for handheld ECG, respectively. Positive predictive values were 5.8% (5.3%-6.1%), 13.8% (12.2%-14.8%) and 25.2% (24.2%-25.8%), respectively. All negative predictive values were ≥99.7%. CONCLUSION: In detecting AF, electronic blood pressure measurement (WatchBP Home A), but especially handheld ECG (MyDiagnostick) showed better diagnostic accuracy than radial pulse palpation. TRIAL REGISTRATION NUMBER: Netherlands Trial Register No. NL4776 (old NTR4914).

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

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).

Consumer-led screening for atrial fibrillation using consumer-facing wearables, devices and apps: A survey of health care professionals by AF-SCREEN international collaboration.

AIM: A variety of consumer-facing wearables, devices and apps are marketed directly to consumers to detect atrial fibrillation (AF). However, their management is not defined. Our aim was to explore their role for AF screening via a survey. METHODS AND RESULTS: An anonymous web-based survey was undertaken by 588 health care professionals (HCPs) (response rate 23.7%). Overall, 57% HCPs currently advise wearables/apps for AF detection in their patients: this was much higher for electrophysiologists and nurses/allied health professionals (74-75%) than cardiologists (57%) or other physicians (34-38%). Approximately 46% recommended handheld (portable) single-lead dedicated ECG devices, or, less frequently, wristband ECG monitors with similar differentials between HCPs . Only 10-15% HCPs advised photoplethysmographic wristband monitors or smartphone apps. In over half of the HCP consultations for AF detected by wearables/apps, the decision to screen was entirely the patient's. About 45% of HCPs perceive a potential role for AF screening in people aged >65 years or in those with risk factors. Almost 70% of HCPs believed we are not yet ready for mass consumer-initiated screening for AF using wearable devices/apps, with patient anxiety, risk of false positives and negatives, and risk of anticoagulant-related bleeding perceived as potential disadvantages, and perceived need for appropriate management pathways. CONCLUSIONS: There is a great potential for appropriate use of consumer-facing wearables/apps for AF screening. However, it appears that there is a need to better define suitable individuals for screening and an appropriate mechanism for managing positive results before they can be recommended by HCPs.

Detecting and Diagnosing Atrial Fibrillation (D2AF): study protocol for a cluster randomised controlled trial.

BACKGROUND: Atrial fibrillation is a common cause of stroke and other morbidity. Adequate treatment with anticoagulants reduces the risk of stroke by 60 %. Early detection and treatment of atrial fibrillation could prevent strokes. Atrial fibrillation is often asymptomatic and/or paroxysmal. Case-finding with pulse palpation is an effective screening method, but new methods for detecting atrial fibrillation have been developed. To detect paroxysmal atrial fibrillation ambulatory rhythm recording is needed. This study aims to determine the yield of case-finding for atrial fibrillation in primary care patients. In addition, it will determine the diagnostic accuracy of three different case-finding methods. METHODS/DESIGN: In a multicenter cluster randomised controlled trial, we compare an enhanced protocol for case-finding of atrial fibrillation with usual care. We recruit 96 practices. We include primary care patients aged 65 years or older not diagnosed with atrial fibrillation. Within each practice, a cluster of 200 patients is randomly selected and marked. Practices are evenly randomised to intervention or control group. The allocation is not blinded. When a marked patient visits an intervention practice, the case-finding protocol starts, consisting of: pulse palpation, sphygmomanometer with automated atrial fibrillation detection and handheld single-lead electrocardiogram (ECG). All patients with at least 1 positive test and a random sample of patients with negative tests receive a 12-lead ECG. Patients without atrial fibrillation on the 12-lead ECG, undergo additional continuous Holter and use the handheld single-lead ECG at home for 2 weeks. Control practices provide care as usual. The study runs for 1 year in each cluster. The primary outcomes are the difference in detection rate of new AF between intervention and control practices and the accuracy of three index tests to diagnose AF. We are currently recruiting practices. The 'Detecting and Diagnosing Atrial Fibrillation' (D2AF) study will determine the yield of an intensive case-finding strategy and the diagnostic accuracy of three index tests to diagnose atrial fibrillation in a primary care setting. TRIAL REGISTRATION: Netherlands Trial Register: NTR4914 , registered on the 25 of November 2014.