This study aimed to evaluate the reproducibility of office (OBP), ambulatory (ABP), and home blood pressure (HBP) measurements in children and adolescents, and their implications in diagnosing hypertension in clinical practice and in pediatric hypertension research. Apparently healthy children and adolescents referred for suspected hypertension were included. Measurements of 2-visit OBP, 7-day HBP, and 24-hour ABP were performed twice, 1 to 6 months apart. Reproducibility was quantified using the SD of differences between repeated measurements. The sample size of clinical trials comparing the efficacy of antihypertensive drugs using each method was calculated. Fifty-eight individuals were analyzed (mean age, 13.0±2.9 years, 60.3% boys). The reproducibility of 24-hour ABP (SD of differences 5.7/4.5 systolic/diastolic) and HBP (5.9/5.0 mm Hg) were comparable and superior to that of visit-2 OBP (9.2/7.8) and awake (6.7/5.5) or asleep ABP (7.6/6.1). As a consequence, a parallel-group comparative trial aiming to detect a difference in the effect of 2 drugs of 10 mm Hg systolic BP, would require 36 participants when using OBP measurements, 14 using 24-hour ABP, and 15 using HBP (102/34/42 respectively for detecting a 5 mm Hg difference in diastolic BP). For a crossover design trial, the corresponding sample sizes are 9/3/4 for systolic BP and 26/9/11 for diastolic, respectively. These data suggest that in children and adolescents 24-hour ABP and 7-day HBP have similar reproducibility, superior to OBP and daytime or asleep ABP. These findings have major implications in diagnosing hypertension in children in clinical practice and in designing clinical research trials in pediatric hypertension.
Blood pressure (BP) is a vital sign, and its measurement is essential for diagnosing and treating hypertension. The accuracy of BP monitors is therefore essential, but unfortunately very few devices available on the market have been validated using an established protocol. STRIDE BP (www.strid ebp.org) is an international nonprofit organization with the mission to improve the accuracy of BP measurement and the diagnosis of hypertension. It has a prestigious Scientific Advisory Board and operates in affiliation with the European Society of Hypertension, the International Society of Hypertension, and the World Hypertension League. STRIDE BP provides lists of accurate office, ambulatory, and home BP monitors. STRIDE BP performed a systematic review of 419 published validations (270 articles and 260 devices). In these publications, 50 (12%) of the validations were rejected compared with 129 (31%) rejected by STRIDE BP (P < .001). Of 79 validations approved in publications but rejected by STRIDE BP, 7 (9%) were rejected due to device inaccuracy and 72 (91%) due to inadequate study quality (execution, analysis, and reporting). Errors in conducting and reporting published validations must be avoided. Peer review must ascertain that a comprehensive checklist of all aspects of a validation study have been adhered to. The implementation of a Universal Standard for device validation and the global dissemination of information on accurate devices by STRIDE BP are expected to improve the quality and accuracy of BP measurement, which should have a positive impact on the diagnosis and management of hypertension globally. | 1617 STERGIOU ET al.
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