LAUSR

Objective: For the accurate diagnosis of hypertension in children current guidelines recommend the use of out-of-office blood pressure (BP) monitoring, which is based almost exclusively on automated BP monitors. This study reviewed the evidence on the accuracy of automated BP monitors in children. Design and method: A systematic review of validation studies of electronic BP monitors in children (age 3–12 years) according to established validation protocols was performed. Medline and EMBASE databases were searched via Dialog ProQuest. Results: The initial literature search retrieved 4,156 articles and 28 were analyzed (31 validation studies of 29 devices; n = 3,067 including 1,450 children). 13 articles (42%) were published a decade ago or longer. Sixteen studies (52%) included children and also adolescents and 5 (16%) also adults. 11 studies that included children and older subjects did not report the number of children. From the 29 devices validated, 16 (55%) were designed for professional office BP measurement, 7 (24%) for ambulatory BP monitoring and 6 (21%) for home monitoring. Fourteen studies (45%) applied validation criteria of more than one protocols. The Association for the Advancement of Medical Instrumentation and/or International Organization for Standardization protocol was used in 20 studies (65%), the British Hypertension Society protocol in 18 (58%) and the European Society of Hypertension International protocol in 6 (19%). Korotkov K5 was used for reference diastolic BP in 14 studies, K4 in one study, and 4 studies used K4 or K5 depending on the subject (not reported in 12 studies). Results from children were reported together with those of older subjects (adolescents or adolescents and adults) in 26 studies (84%). Twenty-two studies (71%) passed the validation protocol requirements, and 9 (29%) failed (6 for systolic and diastolic BP, and 3 for diastolic only). Conclusions: The published evidence on the accuracy of electronic BP monitors in children is limited and with considerable heterogeneity. There is need for: (i) more automated devices to be tested in children; (ii) a universal protocol that meets the specific issues of children to be developed, (ii) the review process for publishing validation studies to follow a detailed checklist.