Effectiveness of a new one-hour blood pressure monitoring method to diagnose hypertension: a diagnostic accuracy clinical trial protocol

Abstract

Introduction24-hour ambulatory blood pressure monitoring (ABPM) is the gold standard diagnostic method for hypertension, but has some shortcomings in clinical practice while clinical settings often lack sufficient devices to accommodate all patients with suspected hypertension. Home blood pressure monitoring (HBPM) and office blood pressure monitoring (OBPM) also have shortcomings, such as the white coat effect or a lack of accuracy. This study aims to study the validity of a new method of diagnosing hypertension consisting of monitoring blood pressure (BP) for 1 hour and comparing it with OBPM and HBPM and examining the sensitivity and specificity of this method compared with 24-hour ABPM. The patient experience will be examined in each method.Methods and analysisA minimum sample of 214 patients requiring a diagnostic test for hypertension from three urban primary healthcare centres will be included. Participants will undergo 24-hour ABPM, 1-hour BP measurement (1-BPM), OBPM for three consecutive weeks and HBPM. Patients will follow a random sequence to first receive 24-hour ABPM or 1-hour ABPM. Daytime 24-hour ABPM records will be compared with the other monitoring methods using the correlation coefficient and Bland Altman plots. The kappa concordance index and the sensitivity and specificity of the methods will be calculated. The patient’s experience will be studied, with selected indicators of efficiency and satisfaction calculated using parametric tests.Ethics and disseminationThe protocol has been authorised by the research ethics committee of the Hospital Clinic of Barcelona (Ref. HCB/2014/0615): protocol details and amendments will be recorded and reported to ClinicalTrials.com. The results will be disseminated in peer-reviewed literature, and to policy makers and healthcare partners.Trial registrationNCT03147573; Pre-results.