Accuracy of validated blood pressure measuring devices for out-of-office measurement in children and adolescents: a systematic review and meta-analysis

Abstract

Background: Blood pressure (BP) measuring devices must demonstrate clinical accuracy proven by proper validation testing in the intended population, following recommendations published by scientific organizations.

Objectives: This review aims to evaluate out-of-office validated BP measuring devices in children and adolescents and discuss their accuracy based on current validation standards.

Study eligibility criteria: Only successful, validated studies for out-of-office BP measuring devices were included. Studies for office blood pressure measuring (OBPM) devices or devices that failed validation were excluded.

Study appraisal and synthesis methods: Based on the eligibility criteria, 17 validation studies on BP measuring devices were included, 8 for home blood pressure measurement (HBPM), and 9 for ambulatory blood pressure measurement (ABPM). The accuracy of validated devices and the quality of the eligible studies were evaluated using the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018).

Data sources: The systematic search was conducted through three search engines (PubMed, Scopus, and CENTRAL (Cochrane Central Register of Controlled Trials)).

Results: When assessing on AAMI/ESH/ISO 2018 validation criterion 1, HBPM devices showed significantly lower accuracy than ABPM devices, in terms of absolute mean difference (MD, in mmHg) for systolic blood pressure (SBP) (1.35, 95%CI: 0.21 to 2.50, P = 0.023). Meta-analysis results using signed values showed no significant difference (ABPM: -0.49 mmHg, 95%CI: -1.40 to 0.41; HBPM: 1.34 mmHg, 95%CI: -0.55 to 3.24; P = 0.086). Sensitivity and subgroup analyses showed high heterogeneity (I² > 90%). Τhe assessment of studies' quality revealed inadequate reporting on the validation procedure.

Limitations: The primary limitation was the lack of separate reporting for the pediatric population concerning the parameters used in the validation process.

Conclusions and implications of key findings: Few BP devices are validated for out-of-office use in the pediatric population, with ABPM devices showing higher accuracy than HBPM devices. Compliance with pediatric-specific validation recommendations should be encouraged to ensure the accuracy of these devices in the pediatric population, while manufacturer-independent, systematic validation studies are needed. SYSTEMATIC REVIEW REGISTRATION NUMBER: PROSPERO ID-CRD42025643559.

Keywords: Adolescents; Ambulatory BP; BP measuring devices; Children; Home BP; Validation; Οut-of-office BP measurement.