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Background <p>Blood pressure (BP) measuring devices must demonstrate clinical accuracy proven by proper validation testing in the intended population, following recommendations published by scientific organizations.</p> Objectives <p>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.</p> Study eligibility criteria <p>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.</p> Study appraisal and synthesis methods <p>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).</p> Data sources <p>The systematic search was conducted through three search engines (PubMed, Scopus, and CENTRAL (Cochrane Central Register of Controlled Trials)).</p> Results <p>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<i>,</i> 95%CI: 0.21 to 2.50, <i>P</i> = 0.023). Meta-analysis results using signed values showed no significant difference (ABPM: −0.49&#xa0;mmHg, 95%CI: −1.40 to 0.41; HBPM: 1.34&#xa0;mmHg, 95%CI: −0.55 to 3.24; <i>P</i> = 0.086). Sensitivity and subgroup analyses showed high heterogeneity (I<sup>2</sup> &gt; 90%). Τhe assessment of studies' quality revealed inadequate reporting on the validation procedure.</p> Limitations <p>The primary limitation was the lack of separate reporting for the pediatric population concerning the parameters used in the validation process.</p> Conclusions and implications of key findings <p>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.&#xa0;</p> Systematic review registration&#xa0;number <p><i>PROSPERO ID-</i>CRD42025643559.</p> Graphical abstract <p></p>

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

  • 期刊论文

  • 发表日期：

    2025年11月27日

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  • Kleo Evripidou,
  • Athanasia Chainoglou,
  • Christina Antza,
  • Carla Simao,
  • Ioannis Goulas,
  • Javier Calpe,
  • Vasilios Kotsis,
  • Gilad Hamdani,
  • Stella Stabouli

摘要

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.

Graphical abstract