VALIDATED BLOOD PRESSURE MEASURING DEVICES FOR CHILDREN: STRIDE BP SYSTEMATIC REVIEW AND META-ANALYSIS

Objective: Validated automated cuff devices are recommended for all the blood pressure (BP) measurement methods. Children represent a special population requiring separate validation. Guidelines state that if hypertension is detected by the oscillometric method, it must be confirmed by the auscultatory one due to potential overestimation. This study assessed the current evidence on validation studies and accuracy of automated upper arm cuff BP devices for children. Design and method: STRIDE BP (www.stridebp.org) performs periodic systematic PubMed search for validation studies of automated cuff BP devices using an established protocol. Studies from the STRIDE BP database including children were analysed. Results: Fifty of 569 studies in the STRIDE BP database included children, and 40 (80%) concluded that the test device passed the validation protocol requirements. STRIDE BP approved 21 studies (42%) as 19 published had major protocol violations even though they were published as “device pass”. The 21 STRIDE BP approved studies validated 19 devices (13 still on the market). By considering devices with “equivalent measurement function”, 25 were approved (17 on the market). Meta-analysis of 18 STRIDE BP approved studies (N=1,306) including children and older individuals showed pooled mean BP difference 0.7 (95% CI -0.1, 1.6)/-0.7 (-1.5, 0.2). Meta-analysis of 7 studies (N=410) in children (3-12 years) showed mean difference 1.0 (95% CI -0.7, 2.8)/-1.3 (-2.9, 0.4). Conclusions: Several manufacturers developed accurate automated BP devices which can replace auscultatory devices for office and out-of-office use as in the adults. However, there is a serious shortage of validated devices for children with published studies often having major methodological issues. There is an urgent need for more BP devices to be validated in children.