P074 STRIDE BP SYSTEMATIC REVIEW OF PUBLISHED VALIDATION STUDIES OF BLOOD PRESSURE MEASURING DEVICES

Background and Objective: The accuracy of blood pressure (BP) monitors is essential for an accurate diagnosis, yet few devices have been validated using an established protocol. This study assessed the published evidence on validation studies of BP monitors. Methods: STRIDE BP (www.stridebp.org) performs periodic systematic PubMed searches to identify published validation studies of automated cuff BP monitors. Validation studies conducted using an established protocol, including the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018), ANSI/AAMI/ISO 2013/2009, ESH-IP 2010/2002, AAMI 2002/1992/1987, and the BHS 1993/1990, were identified from the STRIDE BP database. Results: Of 569 validation studies included in the STRIDE BP database, 238 (42%) used the ESH-IP, 153 (27%) the AAMI/ISO, 132 (23%) the BHS, and 46 (8%) the AAMI/ESH/ISO Universal Standard. These studies evaluated 346 devices (upper-arm 290; wrist 56) intended for office (55), ambulatory (44), home (233), public space/kiosk (8), and hospital (6) BP measurements. Among the 569 reviewed studies the STRIDE BP review process rejected 202 (35.5%) due to major violation of the validation protocol and/or device failure to pass the protocol's requirements. Six of 46 validation studies that used the most recent AAMI/ESH/ISO Universal Standard were rejected (13%), versus 190 (36.3%) using older validation protocols. STRIDE BP concluded that 280 of total 346 BP devices (81%; upper-arm 236; wrist 44) fulfilled the protocol's requirements and can be recommended for clinical use. Among these 280 devices, 106 (37.6%) were selected by STRIDE BP as preferred devices (fulfilling additional requirements), and 182 (65%) are available on the market (Table). Conclusions: This analysis highlights a shortage of validated BP monitors available on the market, particularly for office and 24-hour ambulatory use. It is encouraging that fewer validation studies using the most recent AAMI/ESH/ISO Universal Standard were rejected by STRIDE BP than older studies using previous protocols, suggesting an improvement in the quality of published validation studies. Table. STRIDE BP systematic review of published validation studies.