Methods of Blood Pressure Assessment Used in Milestone Hypertension Trials

Abstract

In the present review, we summarized the blood pressure (BP) measurement protocols of contemporary outcome trials in hypertension. In all these trials, clinic BP was used for the diagnosis and therapeutic monitoring of hypertension. In most trials, BP was measured in the sitting position with mercury sphygmomanometers or automated electronic BP monitors by trained observers. BP readings were taken on each occasion at least twice with a 30-to-60-s interval after 5 min of rest. Details regarding the arm side, cuff size, and the timing of BP measurement were infrequently reported. If clinic BP continues being used in future hypertension trials, the measurement should strictly follow current guidelines. The observers must be trained and experienced, and the device should be validated by automated electronic BP monitors. On each occasion, BP readings should be taken 2-3 times. The time interval between successive measurements has to be 30-60 s, and the resting period before the measurement should be at least 5 min in the supine or seated position and 1-3 min standing. BP should usually be measured in the seated position. The higher arm side and an appropriate size cuff should be chosen and noted. BP should be measured at defined trough hours. Automated office BP measurement has recently been used and seems to have less white-coat effect. The out-of-office BP measurement, either ambulatory or home BP monitoring, was only used in a subset of study participants of few hypertension trials. Future trials should consider these novel office or out-of-office BP measurements in guiding the therapy and preventing cardiovascular events.

Keywords: Assessment; Blood pressure; Clinical trials; Hypertension; Methods.