European Society of Hypertension International Protocol for the validation of blood pressure monitors: a critical review of its application and rationale for revision.

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 < or =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.