Blood pressure trajectory from birth to preschool - and school-age: evidence from environage birth cohort

Abstract

Objective: BP measurement devices must demonstrate clinical accuracy proved by proper validation testing in the intended population, following the standards published by the internationally accepted protocols. This review aims to evaluate out-of-office blood pressure (BP) validated devices using current validation protocols in children. Design and method: The eligibility criteria included observational studies published after 2000, with successful validation for automatic, oscillometric BP measurement devices in the pediatric population, for out-of-office settings, either home BP or ambulatory BP monitoring (HBPM or ABPM) devices. The review was conducted per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The accuracy of devices was assessed based on the mean BP difference between reference and test device measurement and its standard deviation (SD), following the AAMI/ESH/ISO 2018 statement. The quality of the eligible studies was evaluated using the checklist for validation studies using the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) from the European Society of Hypertension (ESH) Working Group on BP Monitoring. Results: Based on the eligibility criteria, this review included 17 studies, 8 devices for HBPM and 9 for ABPM. The reported characteristics were the number (N) of participants including pediatric ones, the characteristics of the devices and the cuffs used, the validation protocol used in each study, and the manufacturer. The primary limitation of the included studies was the lack of separate reporting for the pediatric population concerning the parameters used in the validation process. When assessing validation criteria 1, HBPM devices generally showed slightly lower accuracy than ABPM devices, with statistical significance only for mean SBP difference (p=0,023, CI: 0,21 to 2,50). All validation studies followed at least one internationally recognized protocol. Almost half of the devices (47%) have been validated based on multiple protocols. Conclusions: Several BP measurement devices have been validated for use in the pediatric population. However, the reporting rate of results in studies in the pediatric population for out-of-office BP measurement devices is low and several pitfalls were noted in the validation procedure. Acknowledgments: COST Action HyperChildNET (CA19115) (COST (Europe-an Cooperation in Science and Technology), Horizon 2020 Framework Program of the European Union).