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

Luis González-de Paz, Belchin Kostov, Maria Del Carme Alvira-Balada, Cristina Colungo, Noemí García, Silvia Roura, Esther Blat, Cristina Sierra-Benito, Josep Miquel Sotoca-Momblona, Jaume Benavent-Areu, Eva Sánchez, Antoni Sisó-Almirall, Eva Sanchez on behalf of the OMBP Group, Monserrat Serrato, Ingrid Vidiella, Elisa Pérez, María Ortega, Silvia Porcar, Xavier Freixa, Maica Herranz, Berta De Andrés, Elena Lagarda, Luis González-de Paz, Belchin Kostov, Maria Del Carme Alvira-Balada, Cristina Colungo, Noemí García, Silvia Roura, Esther Blat, Cristina Sierra-Benito, Josep Miquel Sotoca-Momblona, Jaume Benavent-Areu, Eva Sánchez, Antoni Sisó-Almirall, Eva Sanchez on behalf of the OMBP Group, Monserrat Serrato, Ingrid Vidiella, Elisa Pérez, María Ortega, Silvia Porcar, Xavier Freixa, Maica Herranz, Berta De Andrés, Elena Lagarda

Abstract

Introduction: 24-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 analysis: A 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 dissemination: The 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 registration: NCT03147573; Pre-results.

Keywords: blood pressure; hypertension diagnosis; primary healthcare; white coat effect.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Research visits and content of study assessments (left) and flow chart of study design (right). 1-BPM, 1-hour ambulatory blood pressure monitoring; 24-hour ABPM, 24-hour ambulatory blood pressure monitoring; HBPM, home blood pressure monitoring; OBPM, office blood pressure monitoring.

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