Table 1.

Description of studies, relevant to the scope, included by the sponsor to support the use of the WatchBP Home A in a clinical setting, plus the study used to estimate the diagnostic accuracy of pulse palpation

Study	Study design	Setting and population	Intervention (I) and comparator (C)	Outcomes	Limitations and generalisibility (to UK setting)
Wiesel et al. [22]	Cross-sectional diagnostic accuracy study	US urban cardiology practice 125 inpatients (53 documented with AF) 446 outpatients (54 documented with AF)	I: Omron 712C automatic sphygmomanometer. 2 successive positive readings indicates AF C: 12-lead ECG	Sensitivity, specificity and diagnostic accuracy of device to detect AF compared with gold standard (ECG)	Moderate methodological quality (early-stage research study) US inpatient and outpatient setting not equivalent to UK primary care (e.g., greater prevalence of AF). Differences in measurement protocol of devicea
Wiesel et al. [25]	Cross-sectional diagnostic accuracy study	Two US cardiology outpatient clinics Unselected outpatients (n = 405)	I: Microlife BP3MQ1-2D HBPM with AF detection. 2/3 positive readings indicates AF (or 3 sequential readings) C: 12-lead ECG	Sensitivity and specificity of device to detect AF compared with gold standard (ECG) Subgroup analysis of false positives	Moderate methodological quality US cardiology outpatient setting may not reflect UK general practice (e.g., greater prevalence of AF)
Stergiou et al. [24]	Cross-sectional diagnostic accuracy study	Greek outpatient hypertension clinic and healthy volunteers Patients (n = 73) had known sustained AF or other arrhythmias (68 %) or sinus rhythm (control, 32 %)	I: Microlife BPA100 Plus HBPM with AF detection. 3 positive successive readings indicates AF C: Simultaneous 12-lead ECG	Sensitivity and specificity of device compared with gold standard (ECG)	Moderate methodological quality Developmental study: arrhythmia status of patients known Setting does not reflect UK community population or use of a screening device Differences in measurement protocol of devicea
Hobbs et al. [16]b	Pragmatic cluster RCT (and accompanying decision-analytic economic model)	UK primary-care setting Patients aged 65 years and over, recruited from 25 control GP practices (n = 4,936) and 25 intervention practices (n = 4,933 opportunistic, 4,933 systematic screening)	I: Pulse palpation through opportunistic screening C: Control group (no screening). Presence of AF verified using 12-lead ECG gold standard	Sensitivity and specificity of pulse palpation to detect AF compared with gold standard (ECG)	High-quality health technology assessment using RCT methodology UK primary-care setting directly reflects the population described in the decision scope of the decision problem

AF atrial fibrillation, C comparator, ECG electrocardiogram, GP General Practitioner, HBPM home blood pressure monitor, I intervention, RCT randomised control trial, UK United Kingdom, US United States of America

^aWhen used in a clinical environment, the WatchBP Home A requires 2/3 positive readings to make a diagnosis of AF. Some studies have used different protocols (e.g., two or three successive readings) which will impact on the reported sensitivity and specificity of the device

^bStudy used to estimate diagnostic accuracy of pulse palpation (comparator)