Establishing the minimal sufficient number of measurements to validate a 24h blood pressure recording

Abstract

Background: Ambulatory blood pressure (BP) monitoring (ABPM) remains a reference standard but the number of readings required to make the measurement valid has not been empirically validated. Methods: Among 360 patients with chronic kidney disease and 38 healthy controls, BP was recorded 2 per hour during the night and 3 per hour during the day over 24h using a validated ABPM device; all had at least 90% of the expected readings. From this full set of ABPM recording, a variable number of BP measurements were selected and we compared the performance of the selected readings against that of the full sample using random or sequential selection schemes. To address the question whether random or sequential selection schemes affect the diagnostic performance in diagnosing hypertension control we compared the diagnostic decisions reached with the subsample and the full sample using area under the receiver operating-characteristic curves (AUC ROC). To answer the question regarding the number of readings needed to achieve over 90% coverage of the mean BP of the full ABPM sample we ascertained the point and confidence interval (CI) estimates based on the selected data. Results: To diagnose hypertension control, the number of readings randomly drawn to establish lower bound with 2.5% error of area under the receiver operating-characteristic curve (AUC ROC) of 0.9 was 3, 0.95 was 7, and 0.975 was 13 . In contrast, the corresponding number of readings with serial selections was 18, 30 and 39 respectively. With a random selection scheme, 18 readings provided 80% coverage of the 90th percentile of CI of the true systolic BP mean, for 90% coverage, 26 readings were needed, for 95% coverage 33. With serial selections, the number of readings increased to 42, 47, and 50 respectively. Similar results emerged for diastolic BP. Conclusions: For diagnosing hypertension control 3 random measurements or 18 serial measurements is sufficient. For quantitative analysis, the minimal sufficient number of 24h ambulatory BP is 26 random recordings or 42 serial recordings.