BACKGROUND: A high percentage of hypertensive patients present an arm circumference of over 32 cm; the use of a large cuff is therefore recommended. Validation studies are usually performed in the general population using a standard-size cuff. The aim of this study was to assess the accuracy of the Omron M7 device in a population with an arm circumference ranging from 32 to 42 cm. DESIGN: A validation study was performed according to the International Protocol of the European Society of Hypertension. This protocol is divided into two phases: the first phase is performed on 15 selected participants (45 pairs of blood-pressure measurements); if the device passes this phase, 18 supplementary participants are included (54 pairs of blood-pressure measurements), making a total number of 33 participants (99 pairs of blood-pressure measurements), on whom the analysis is performed. METHODS: For each participant, four blood-pressure measurements were performed simultaneously by two trained observers, using mercury sphygmomanometers fitted with a Y tube; the measurements alternated with three by the test device. The difference between the blood-pressure value given by the device and that obtained by the two observers (mean of the two observations) was calculated for each measure. The 99 pairs of blood-pressure differences were classified into three categories (<or=5, <or=10 and <or=15 mmHg). The number of differences in each category was compared with the number required by the European Society of Hypertension protocol. RESULTS: The Omron M7 device passed the first and the second phases of the validation process. The average differences between the two observers were 1.5+/-3.2 and -0.5+/-2.2 mmHg for systolic blood pressure and diastolic blood pressure, and those between the device and the mercury sphygmomanometer were -1.6+/-6.7 for systolic blood pressure and -0.12+/-4.0 mmHg for diastolic blood pressure Readings that differ by less than 5, 10 and 15 mmHg for systolic blood-pressure and diastolic blood-pressure values fulfill the recommendation criteria of the European Society of Hypertension protocol. CONCLUSIONS: The Omron M7 (HEM-780-E) device fulfilled the validation criteria of the international protocol in a population with an arm circumference ranging from 32 to 42 cm.
BACKGROUND: A high percentage of hypertensivepatients present an arm circumference of over 32 cm; the use of a large cuff is therefore recommended. Validation studies are usually performed in the general population using a standard-size cuff. The aim of this study was to assess the accuracy of the Omron M7 device in a population with an arm circumference ranging from 32 to 42 cm. DESIGN: A validation study was performed according to the International Protocol of the European Society of Hypertension. This protocol is divided into two phases: the first phase is performed on 15 selected participants (45 pairs of blood-pressure measurements); if the device passes this phase, 18 supplementary participants are included (54 pairs of blood-pressure measurements), making a total number of 33 participants (99 pairs of blood-pressure measurements), on whom the analysis is performed. METHODS: For each participant, four blood-pressure measurements were performed simultaneously by two trained observers, using mercury sphygmomanometers fitted with a Y tube; the measurements alternated with three by the test device. The difference between the blood-pressure value given by the device and that obtained by the two observers (mean of the two observations) was calculated for each measure. The 99 pairs of blood-pressure differences were classified into three categories (<or=5, <or=10 and <or=15 mmHg). The number of differences in each category was compared with the number required by the European Society of Hypertension protocol. RESULTS: The Omron M7 device passed the first and the second phases of the validation process. The average differences between the two observers were 1.5+/-3.2 and -0.5+/-2.2 mmHg for systolic blood pressure and diastolic blood pressure, and those between the device and the mercury sphygmomanometer were -1.6+/-6.7 for systolic blood pressure and -0.12+/-4.0 mmHg for diastolic blood pressure Readings that differ by less than 5, 10 and 15 mmHg for systolic blood-pressure and diastolic blood-pressure values fulfill the recommendation criteria of the European Society of Hypertension protocol. CONCLUSIONS: The Omron M7 (HEM-780-E) device fulfilled the validation criteria of the international protocol in a population with an arm circumference ranging from 32 to 42 cm.
Authors: Ben Corden; Antonio de Marvao; Timothy J Dawes; Wenzhe Shi; Daniel Rueckert; Stuart A Cook; Declan P O'Regan Journal: J Cardiovasc Magn Reson Date: 2016-05-31 Impact factor: 5.364
Authors: Veronica Varela-Mato; Orlagh O'Shea; James A King; Thomas Yates; David J Stensel; Stuart Jh Biddle; Myra A Nimmo; Stacy A Clemes Journal: BMJ Open Date: 2017-06-21 Impact factor: 2.692
Authors: Thomas E Kottke; Jeffrey P Anderson; Jacob D Zillhardt; JoAnn M Sperl-Hillen; Patrick J O'Connor; Beverly B Green; Rae Ann Williams; Beth M Averbeck; Michael N Stiffman; MarySue Beran; Michael Rakotz; Karen L Margolis Journal: JAMA Netw Open Date: 2022-08-01
Authors: A G Lerner; A Bernabé-Ortiz; R Ticse; A Hernandez; Y Huaylinos; M E Pinto; G Málaga; W Checkley; R H Gilman; J J Miranda Journal: Diabet Med Date: 2015-04-07 Impact factor: 4.213