JS-WHL-ISH-LANCET-3: HOW CAN CLINICIANS AND THE PUBLIC DETERMINE WHETHER A BLOOD PRESSURE MEASURING DEVICE IS CLINICALLY VALID?

Abstract

The global market of blood pressure (BP) measuring devices was estimated at USD 2.1 billion in 2021, and the forecast is to grow at 13.5% per year and reach USD 4.5 billion in 2027. The accuracy of cuff BP monitors needs to be tested using one of the established validation protocols, such as the US AAMI, the UK BHS, the European ESH-IP, or the ISO. In 2018 the AAMI/ESH/ISO Universal Standard (ISO 81060–2:2018) was agreed for global use, and using the previous protocols in not encouraged anymore. Unfortunately, of almost 5,000 BP device models on the market, fewer than 10% have a validation study documenting the measurement accuracy using one of the above-mentioned validation protocols and the results published in a peer-review PubMed journal. Another issue is that an electronic BP monitor which has been successfully validated in adults may not be accurate in some special populations, including children, pregnant women, individuals with very large arms (circumference larger than 42 cm) and patients with arrhythmias (particularly atrial fibrillation). Thus, separate validation is necessary in these populations. Thus, it is essential that healthcare professionals, individuals with hypertension, and the public have access to valid information for which devices are properly validated. In 2003, Eoin OBrien founded the first website providing online updated lists of properly validated BP measuring devices. Several websites are currently available providing lists of validated devices (see Table), of which some are national (devices locally available; website in local language), and others do not have scientific supervision. STRIDE BP is a non-profit organisation founded by 24 distinguished scientists, operating in affiliated with the International Society of Hypertension, the European Society of Hypertension, and the World Hypertension League. STRIDE BP has an online peer-review system for PubMed published validation studies, and applies a review process which is more systematic and strict than that of PubMed journals. Thus, STRIDE BP may reject a device which appears as accurate in a PubMed published validation study. STRIDE BP provides lists of validated devices in 3 languages (English, Spanish, Chinese). List of validated devices are provided for adults, but also separately for children and for pregnant women, for use in the office/clinic, at home, and for 24-hour ambulatory BP monitoring. STRIDE BP also has an online accredited e-learning platform for healthcare professionals, with interactive educational modules for the established BP measurement methods (office, home, ambulatory).