Ulrich Tholl1, Stephan Lüders, Peter Bramlage, Ralf Dechend, Siegfried Eckert, Thomas Mengden, Jens Nürnberger, Bernd Sanner, Manfred Anlauf. 1. aDepartment of Internal Medicine III, Karl-Leisner Clinic, St Antonius Hospital, Kleve bCentre of Hypertension, St Josef Hospital cInstitute for Pharmacology and Preventive Medicine, Cloppenburg dCharité University Clinic, Helios Clinic Berlin-Buch, Berlin eDepartment of Cardiology, Heart and Diabetes Centre NRW, Bad Oeynhausen fCentre of Rehabilitation, Kerckhoff-Clinic, Bad Nauheim gDepartment of Nephrology and Dialysis, Helios Clinic, Schwerin hDepartment of Internal Medicine, Agaplesion Bethesda, Wuppertal iMedical Practice of Internal Medicine, Cuxhaven, Germany.
Abstract
OBJECTIVE: The German Hypertension League (Deutsche Hochdruckliga) established a program to assess the accuracy and reliability of blood pressure (BP)-measuring devices in 1999 (Quality Seal Protocol). Here, we report on the results of a testing series of 105 devices designed for BP self-measurement. METHODS: The test protocol for the validation of upper-arm, wrist, and finger devices was developed to compare device to conventional Riva-Rocci measurements based on five criteria: mean systolic and mean diastolic differences, their standard deviations, and a point score representing the correlation of systolic and diastolic errors of individual comparisons. The results of this testing are summarized. RESULTS: From 1999 to 2014, a total of 105 BP devices for self-measurement were tested according to the Quality Seal Protocol. Of these, 47.6% fulfilled all five validation criteria, 55.7% of the upper-arm devices (39 of 71) and 32.4% (11 of 34) of the wrist devices. Finger devices were not offered for testing. Forty-four devices (41.9%) failed multiple test criteria of the validation procedure. A subanalysis with 51 devices tested showed that a stricter definition of the passing point score with a limit of at least 55% would slightly increase the consistency with the conventional criteria in comparison with a point score criterion of at least 50%. It was therefore introduced in 2007. CONCLUSION: The results indicate the importance of a rigorous testing of a BP-measuring device used for home BP measurement to prevent patients from making erroneous treatment decisions.
OBJECTIVE: The German Hypertension League (Deutsche Hochdruckliga) established a program to assess the accuracy and reliability of blood pressure (BP)-measuring devices in 1999 (Quality Seal Protocol). Here, we report on the results of a testing series of 105 devices designed for BP self-measurement. METHODS: The test protocol for the validation of upper-arm, wrist, and finger devices was developed to compare device to conventional Riva-Rocci measurements based on five criteria: mean systolic and mean diastolic differences, their standard deviations, and a point score representing the correlation of systolic and diastolic errors of individual comparisons. The results of this testing are summarized. RESULTS: From 1999 to 2014, a total of 105 BP devices for self-measurement were tested according to the Quality Seal Protocol. Of these, 47.6% fulfilled all five validation criteria, 55.7% of the upper-arm devices (39 of 71) and 32.4% (11 of 34) of the wrist devices. Finger devices were not offered for testing. Forty-four devices (41.9%) failed multiple test criteria of the validation procedure. A subanalysis with 51 devices tested showed that a stricter definition of the passing point score with a limit of at least 55% would slightly increase the consistency with the conventional criteria in comparison with a point score criterion of at least 50%. It was therefore introduced in 2007. CONCLUSION: The results indicate the importance of a rigorous testing of a BP-measuring device used for home BP measurement to prevent patients from making erroneous treatment decisions.
Authors: George S Stergiou; Bruce Alpert; Stephan Mieke; Roland Asmar; Neil Atkins; Siegfried Eckert; Gerhard Frick; Bruce Friedman; Thomas Graßl; Tsutomu Ichikawa; John P Ioannidis; Peter Lacy; Richard McManus; Alan Murray; Martin Myers; Paolo Palatini; Gianfranco Parati; David Quinn; Josh Sarkis; Andrew Shennan; Takashi Usuda; Jiguang Wang; Colin O Wu; Eoin O'Brien Journal: J Hypertens Date: 2018-03 Impact factor: 4.844
Authors: George S Stergiou; Bruce S Alpert; Stephan Mieke; Jiguang Wang; Eoin O'Brien Journal: J Clin Hypertens (Greenwich) Date: 2018-07 Impact factor: 3.738
Authors: James E Sharman; Eoin O'Brien; Bruce Alpert; Aletta E Schutte; Christian Delles; Michael Hecht Olsen; Roland Asmar; Neil Atkins; Eduardo Barbosa; David Calhoun; Norm R C Campbell; John Chalmers; Ivor Benjamin; Garry Jennings; Stéphane Laurent; Pierre Boutouyrie; Patricio Lopez-Jaramillo; Richard J McManus; Anastasia S Mihailidou; Pedro Ordunez; Raj Padwal; Paolo Palatini; Gianfranco Parati; Neil Poulter; Michael K Rakotz; Clive Rosendorff; Francesca Saladini; Angelo Scuteri; Weimar Sebba Barroso; Myeong-Chan Cho; Ki-Chul Sung; Raymond R Townsend; Ji-Guang Wang; Tine Willum Hansen; Gregory Wozniak; George Stergiou Journal: J Hypertens Date: 2020-01 Impact factor: 4.776
Authors: James E Sharman; Eoin O'Brien; Bruce Alpert; Aletta E Schutte; Christian Delles; Michael Hecht Olsen; Roland Asmar; Neil Atkins; Eduardo Barbosa; David Calhoun; Norm R C Campbell; John Chalmers; Ivor Benjamin; Garry Jennings; Stéphane Laurent; Pierre Boutouyrie; Patricio Lopez-Jaramillo; Richard J McManus; Anastasia S Mihailidou; Pedro Ordunez; Raj Padwal; Paolo Palatini; Gianfranco Parati; Neil Poulter; Michael K Rakotz; Clive Rosendorff; Francesca Saladini; Angelo Scuteri; Weimar Sebba Barroso; Myeong-Chan Cho; Ki-Chul Sung; Raymond R Townsend; Ji-Guang Wang; Tine Willum Hansen; Gregory Wozniak; George Stergiou Journal: Rev Panam Salud Publica Date: 2020-03-01