O30 AVAILABILITY OF PROPERLY VALIDATED AUTOMATED BLOOD PRESSURE MEASURING DEVICES FOR CHILDREN: STRIDE BP SYSTEMATIC REVIEW

Background and Objective: Properly validated automated upper-arm cuff blood pressure (BP) measuring devices are currently recommended for office, home, and ambulatory BP measurement. However, the validation of BP devices in children presents additional challenges, necessitating separate studies. This study assessed the evidence on accurate automated BP devices in children. Methods: STRIDE BP (www.stridebp.org) performs periodic systematic PubMed searches to identify validation studies of automated cuff BP monitors. Validation studies including children (3-12 years) 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 BHS 1993/1990, were identified from the STRIDE BP database. Results: Of 569 validation studies included in the STRIDE BP database, 47 (33 devices) were identified including children. Among them, STRIDE BP rejected 29 studies of which 18 were reported as “device pass” in the published paper. Among studies rejected by STRIDE BP but published as “pass”, main reasons for rejection were violations in the BP measurement procedure (sequence, number, repeats) (50%), inadequate reference device or cuffs for reference and test device (16.6%), inadequate sample size (22.2%), and single observer for reference BP (22.2%). Eventually 18 studies in children (38.3%) fulfilled all the validation protocol requirements, and 16 devices (10 available on the market) met the validation requirements and can be recommended for use in children. When additional ‘equivalent’ devices were considered (devices lacking validation studies but with differences from validated devices not affecting the measurement accuracy), 21 devices were found to be accurate, with 13 of them available on the market (Table). Conclusions: This analysis highlight a serious shortage of properly validated BP devices for children available in the market, with published validation studies often having major methodological issues. There is an urgent call to manufacturers and investigators to develop and properly validate more BP devices for children. TABLE. Validated devices for office, home, and ambulatory BP measurement in children.