Objective: To perform a systematic review of validation studies of blood pressure measuring devices done using the European Society of Hypertension International Protocol (ESH-IP) since its publication in 2002.
Methods: Major aspects of ESH-IP studies are described. A review of the ESH-IP performance, problems and violations in its application, and the effect of applying several more stringent validation criteria in an ESH-IP revision is carried out.
Results: From January 2002 to June 2009, 104 validation studies had been conducted using the ESH-IP, 36 using the British Hypertension Society protocol and 28 using the US Association for the Advancement of Medical Instrumentation protocol. Among 78 studies reported up to June 2008, in 66 (85%) the tested device has passed the ESH-IP. In 19 validations a modification of the ESH-IP was performed to adapt for specific study needs (population or device). Protocol violations of the ESH-IP were identified in 23 studies (eight major violations). A test of several arbitrarily chosen changes in the ESH-IP validation criteria applied in the published studies showed the phase 2.1 criterion (BP differences ≤15 mmHg) and the phase 2.2 criteria to be the more stringent.
Conclusion: The ESH-IP has succeeded in expanding the validation procedure worldwide by three to four-fold compared with the period before its publication. There is a need for protocol revision aiming to address issues that appeared in published studies, prevent protocol violations, and ensure complete data reporting. Standardization of the ESH-IP validation studies' report and application of more stringent criteria should be considered.
aHypertension Center, Third University Department of Medicine, Sotiria Hospital, Athens, Greece
bNeil Atkins, dabl®Educational Ltd. Blackrock, Co. Dublin
cEoin O'Brien, Conway Institute of Biomolecular and Biomedical Research, University College Dublin, Ireland
Correspondence to Dr George S. Stergiou, MD, Hypertension Center, Third University Department of Medicine, Sotiria Hospital, 152 Mesogion Avenue, Athens 11527, Greece
Tel: +30 210 7763117; fax: +30 210 7719981; e-mail: firstname.lastname@example.org
Received 24 July 2009
Revised 23 August 2009
Accepted 24 August 2009