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Validated Automated Cuff Blood Pressure Devices for Children: STRIDE BP Report and Call to Action
George S Stergiou1, Ariadni Menti1, Paolo Palatini2
1Hypertension Center STRIDE-7, National and Kapodistrian University of Athens, School of Medicine, Third Department of Medicine, Sotiria Hospital, Athens, Greece (G.S.S., A.M., D.M., A.K.).
Insights
Automated blood pressure devices are recommended for children, but few are validated for pediatric use. More research is urgently needed to ensure accurate blood pressure monitoring in children.
Area of Science:
- Pediatric Cardiology
- Medical Device Validation
- Hypertension Management
Background:
- Automated cuff devices are recommended for pediatric blood pressure (BP) measurement, similar to adults.
- Devices validated in adults may not be accurate in children, necessitating separate validation studies.
- Current guidelines suggest confirming automated device-detected hypertension with auscultation in children.
Purpose of the Study:
- To present evidence on automated BP devices validated for children aged 3-12 years.
- To assess the availability and quality of validation studies for pediatric BP devices.
Main Methods:
- Systematic PubMed searches were performed by STRIDE BP (Science and Technology for Regional Innovation and Development in Europe-Blood Pressure).
- A dataset of validation studies including children was analyzed.
- Meta-analysis was conducted on studies with successful validation and sufficient data.
Main Results:
- Out of 628 studies, 51 included children; only 22 (43%) were approved by STRIDE BP due to protocol violations.
- Twenty automated BP devices were validated in these 22 studies, with 14 currently on the market.
- Meta-analysis showed minimal pooled differences in systolic (0.6 mm Hg) and diastolic (-0.3 mm Hg) BP when including children and older individuals.
Conclusions:
- There is a significant lack of automated BP device models validated for children.
- Published validation studies frequently suffer from methodological issues.
- Validated automated BP devices can aid in diagnosing pediatric hypertension, but more validation studies are urgently required.
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 (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 devices 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.
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