title: Validation protocols for blood pressure-measuring devices: status quo and development needs.
abstract: Hypertension is a major risk factor for cardiovascular morbidity and mortality. Therefore, blood pressure self-measuring devices have emerged as valuable tools in patient care and the accuracy of these instruments is of fundamental importance. For this reason, several validation procedures for assessing the efficacy of blood pressure monitoring devices have been developed, including protocols by the Association for the Advancement of Medical Instrumentation, the British Hypertension Society, the German Hypertension League (Prüfsiegelprotokoll), and the International Protocol of the Working Group on Blood Pressure Monitoring of the European Society of Hypertension. In the past, most of the protocols have been reviewed and modified because of experiences gained during the validation studies carried out. However, each shows distinct differences, that is number and characteristics of patients required, blood pressure ranges, and the length of the validation procedure, which may result in unique advantages and/or limitations associated with their use. The continued standardization and evolution of these guidelines is essential to ensure the efficacy of blood pressure-measuring devices marketed for clinical and home use. Here, we aimed to compare four currently used validation protocols and to initiate a discussion on potential future improvements.
authors.affiliation: aInstitute for Pharmacology and Preventive Medicine, Cloppenburg bEstimate GmbH, Augsburg cKerckhoff Klinik Bad Nauheim, Rehabilitation Centre, Bad Nauheim, Germany dInstitute for Research and Medicine Advancement (IRMEDICA), Barcelona, Spain.
authors.forename: Beate
authors.initials: B
authors.lastname: Beime
authors.forename: Cornelia
authors.initials: C
authors.lastname: Deutsch
authors.forename: Timothy
authors.initials: T
authors.lastname: Gomez
authors.forename: Thomas
authors.initials: T
authors.lastname: Zwingers
authors.forename: Thomas
authors.initials: T
authors.lastname: Mengden
authors.forename: Peter
authors.initials: P
authors.lastname: Bramlage
mesh_terms: D001794:Blood Pressure; D001795:Blood Pressure Determination / Q000295:instrumentation* / Q000379:methods / Q000592:standards; D006801:Humans; D006973:Hypertension / Q000175:diagnosis; D012955:Societies, Medical; D019722:Sphygmomanometers / Q000592:standards; D054928:Validation Studies as Topic