Validated Automated Cuff Blood Pressure Devices for Children: STRIDE BP Report and Call to Action.
TL;DR
There is an urgent need for more automated BP devices to be validated in children as there is a severe shortage of validated automated BP device models for children.
Abstract
Background
Similar to adults, in children automated cuff devices are recommended for office, home, and ambulatory blood pressure (BP) measurement. However, a device validated in adults may not be accurate in children, and separate investigation is necessary. Moreover, current pediatric guidelines recommend hypertension detected by an automated device to be confirmed using auscultation. The evidence on validated automated BP devices for children (aged 3-12 years) is presented.
Methods
STRIDE BP (Science and Technology for Regional Innovation and Development in Europe-Blood Pressure; www.stridebp.org) performs periodic systematic PubMed searches for validation studies of automated BP devices. The data set of studies including children was analyzed.
Results
Fifty-one of 628 studies in the STRIDE BP database included children. Forty-one (80%) concluded that the test device passed the validation, yet due to protocol violations, STRIDE BP approved 22 of them (43%). These 22 studies validated 20 devices (14 on the market). Seven additional devices had measurement functions equivalent to STRIDE BP-approved devices (6 on the market). Meta-analysis of 20 successful studies including children and older individuals (N=1476) showed a pooled test-reference systolic BP difference of 0.6 mm Hg (95% CI, -0.2 to 1.4), and diastolic -0.3 (95% CI, -1.2 to 0.6). Meta-analysis of 7 studies including only children (N=410) showed a pooled difference of 1.0 (95% CI, -0.7 to 2.8)/-1.3 (95% CI, -2.9 to 0.4) mm Hg.
Conclusions
There is a severe shortage of validated automated BP device models for children, with published studies often having methodological issues. Some devices are validated in children and, as in adults, can replace auscultatory devices for office hypertension diagnosis. There is an urgent need for more automated BP devices to be validated in children.