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Publications (10)9.42 Total impact

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    ABSTRACT: Two electronic devices for self-measurement of blood pressure - a brachial monitor, the Omron M6, and a wrist monitor, the Omron R7 - were evaluated in two separate studies according to the International Protocol of the European Society of Hypertension. The International Validation 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 final validation is performed. The same methodology recommended by the European Society of Hypertension protocol was applied for both studies. In each study and for each participant, four blood pressure measurements were taken simultaneously by two trained observers using mercury sphygmomanometers alternately with three measurements taken by the tested device. The difference between the blood pressure value given by the device and that obtained by the two observers (mean of the two observers) 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 International Protocol. An individual analysis was then done to determine the number of comparisons <or=5 mmHg for each participant. At least 22 of the 33 participants should have two of their three comparisons <or=5 mmHg. In both studies, the two tested devices passed the first and the second phases of the validation process. The average differences between the device and mercury sphygmomanometer readings were 0.8+/-2.7 and -1.9+/-3.3 mmHg for systolic and diastolic blood pressure, respectively, for the Omron M6 device, and 0.2+/-4.2 and 0.2+/-2.9 mmHg for systolic and diastolic blood pressure, respectively, for the Omron R7 device. For both devices, readings differing by less than 5, 10 and 15 mmHg for systolic and diastolic blood pressure values fulfill the recommendation criteria of the International Protocol as well as the individual analysis. The Omron M6 (HEM-7001-E) and the Omron R7 (HEM 637-IT) devices fulfilled the validation recommendations of the International Protocol.
    Blood Pressure Monitoring 07/2006; 11(3):165-71. · 1.80 Impact Factor
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    ABSTRACT: The aim of the present study was to validate the OMRON ® M6 automatic oscillometric blood pressure (BP) device according to the International Protocol (1). This device measures BP at the arm level. It is to be shown whether it provides accurate BP measurements. The International validation protocol was published by the European Society of Hypertension and can be applicable to the majority of BP measuring devices on the market. It is a simplified protocol that does not sacrifice the integrity of the earlier Association for the Advancement of Medical Instrumentation (AAMI) and British Hypertension Society (BHS) protocols (2,3).
    01/2006;
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    ABSTRACT: Two electronic devices for self-measurement of blood pressure at the brachial artery -- the Seinex SE-9400 and the Microlife BP 3AC1-1 -- were evaluated in two separate studies according to the International Protocol of the European Society of Hypertension. The international validation protocol is divided into two phases: the first phase is performed on 15 selected participants (45 blood pressure measurements); if the device passes this phase, 18 supplementary participants are included (54 blood pressure measurements) making a total number of 33 participants (99 blood pressure measurements) on whom the final validation is performed. The same methodology recommended by the European Society of Hypertension protocol was applied for both studies. In each study and for each participant, four blood pressure measurements were taken simultaneously by two trained observers using mercury sphygmomanometers alternately with three measurements by the tested device. The difference between the blood pressure value given by the device and that obtained by the two observers (mean of the two observers) was calculated for each measure. The 99 differences were classified into three categories (< or =5, < or =10, < or =15 mmHg). The number of differences in each category was compared with the number required by the ESH protocol. An individual analysis was then done to determine, for each participant, the number of comparisons < or =5 mmHg. At least 22 of the 33 participants should have two of their three comparisons < or =5 mmHg. In both studies, the two tested devices passed the first phase of the validation process. For the complete analysis (phase 1 and phase 2), the average differences between the device and mercury sphygmomanometer readings were in the first study for the Seinex SE-9400 device 0.9+/-5.2 and -1.7+/-4.7 mmHg for systolic and diastolic blood pressure, respectively, and -0.2+/-4.5 and -2.0+/-4.8 mmHg for the Microlife BP 3AC1-1 device in the second study. For both devices, readings differing by less than 5, 10 and 15 mmHg for systolic and diastolic blood pressure values fulfill the recommendation criteria of the International Protocol as well as the individual analysis. The Seinex SE-9400 and the Microlife BP 3AC1-1 devices fulfilled the validation recommendations of the International Protocol.
    Blood Pressure Monitoring 12/2005; 10(6):325-31. · 1.80 Impact Factor
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    ABSTRACT: Objective: The aim of this study was to perform a clinical validation of the SEINEX® SE-9400 blood pressure (BP) measuring device according to the International validation Protocol.Design and Methods: The International validation Protocol is divided into 2 phases: the first phase is performed on 15 subjects fulfilling the inclusion criteria requested by the protocol; the second phase is performed on additional 18 subjects, only if the device passes the first phase. The inclusion criteria require selection of subjects according to BP ranges. For each subject, 4 BP measurements were performed simultaneously by 2 observers (trained according to the French Hypertension Society criteria) using standard mercury sphygmomanometers alternately with 3 measurements by SEINEX. The difference (D) between the BP value given by the device and that obtained by the 2 observers (mean of the 2 observers) was calculated for each measure. The 99 differences (D) were classified into categories (≤ 5, ≤ 10, ≤ 15 mmHg). The number of D (n) in each category was compared to the number required by the International Protocol. An individual analysis was then done to determine for each subject the number of comparisons ≤ 5 mmHg. At least 22 of the 33 subjects should have 2 of their 3 comparisons ≤ 5 mmHg.The mean age of the 33 included subjects (18 men, 15 women) was 54 ± 14 years.Results: The SEINEX® SE-9400 device fulfilled the required criteria of phase 1 (15 subjects) of the International Protocol, which allowed us to continue with phase 2. Regarding the 33 subjects, the difference between the 2 observers was -0.2 ± 1.4 mmHg and 0.2 ± 1.3 mmHg for systolic and diastolic BP respectively.The results of the comparison of the device and the observers are shown in the table.Number of patients having 2 of their 3 comparisons ≤ 5 mmHg was 28 and 29 for systolic and diastolic BP respectively.Conclusion: The SEINEX® SE-9400 device fulfils the recommendations of the international validation protocol.
    01/2005;
  • Mohamed A. El Assaad, Jirar A. Topouchian, Roland G. Asmar
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    ABSTRACT: P-16Key Words: Self-Measurement, Hypertension, Validation
    American Journal of Hypertension - AMER J HYPERTENS. 01/2004; 17(5).
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    Mohamed A El Assaad, Jirar A Topouchian, Roland G Asmar
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    ABSTRACT: Two devices for self-measurement of blood pressure at the brachial artery-the Omron M5-I and the Omron 705IT-were evaluated according to the international protocol of the European Society of Hypertension. The international validation protocol is divided into two phases: the first phase is performed on 15 selected subjects and if the device passes this phase, 18 supplementary subjects are included making a total number of 33 subjects on which the final validation is performed. For each subject, four blood pressure (BP) measurements were performed simultaneously by two trained observers using mercury sphygmomanometers alternately with three measurements by the tested device. The difference between the BP value given by the device and that obtained by the two observers (mean of the two observers) was calculated for each measure. The 99 differences were classified into categories (<or=5, <or=10, <or=15 mmHg). The number of differences in each category was compared to the number required by the international protocol. An individual analysis was then done to determine for each subject the number of comparisons <or=5 mmHg. At least 22 of the 33 subjects should have two of their three comparisons <or=5 mmHg. The two tested devices passed the first phase of the validation process. For the second phase, the average differences between the device and mercury sphygmomanometer readings were -0.9+/-5.8 and -0.8+/-4.8 mmHg for systolic blood pressure (SBP) and diastolic blood pressure (DBP) respectively for the Omron M5-I device and -0.2+/-4.5 and -2.0+/-4.8 mmHg for the Omron 705IT device. Readings for the two devices differing by less than 5, 10 and 15 mmHg for systolic and diastolic values fulfil the recommendation criteria of the international protocol as well as the individual analysis. The Omron M-5I and the Omron 705IT devices pass the validation recommendations of the international protocol.
    Blood Pressure Monitoring 07/2003; 8(3):127-33. · 1.80 Impact Factor
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    ABSTRACT: 1. The aim of this study was to perform a clinical validation of the Microlife BP 3AC1-1 blood pressure (BP) measuring device according to the International validation Protocol.2. The International validation Protocol is divided into 2 phases: the first phase is performed on 15 subjects fulfilling the inclusion criteria requested by the protocol; the second phase is performed on additional 18 subjects, only if the device passes the first phase. The inclusion criteria require to select subjects according to BP ranges. For each subject, 4 BP measurements were performed simultaneously by 2 observers (trained according to the French Hypertension Society criteria) using standard mercury sphygmomanometers alternately with 3 Microlife measurements. The difference (Δ) between the BP value given by the device and that obtained by the 2 observers (mean of the 2 observers) was calculated for each measure. The 99 differences (Δ) were classified into categories (≤ 5, ≤ 10, ≤ 15 mmHg). The number of Δ (n) in each category was compared to the number required by the International Protocol. An individual analysis was then done to determine for each subject the number of comparisons ≤ 5 mmHg. At least 22 of the 33 subjects should have 2 of their 3 comparisons ≤ 5 mmHg.3. The mean age of the 33 included subjects (19 men, 14 women) was 53 ± 14 years. The Microlife device fulfilled the required criteria of the primary phase (15 subjects) of the International Protocol. Regarding the 33 subjects, the difference between the 2 observers was 1.69 ± 1.52 mmHg and −0.03 ± 1.37 mmHg for systolic and diastolic BP respectively. The results of the comparison of the device and the observers are shown in the table below:Number of patients having 2 of their 3 comparisons ≤ 5 mmHg was 29 and 28 for systolic and diastolic BP respectively.4. The Microlife BP 3AC1-1 device fulfils the recommendations of the international validation protocol.
    American Journal of Hypertension - AMER J HYPERTENS. 01/2003; 16(5).
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    ABSTRACT: The aim of this study was to validate the Omron HEM-907 blood pressure (BP) measuring device according to the international validation protocol. The international validation protocol is divided into two phases: the first phase is performed on 15 selected subjects and if the device passes this phase, 18 more subjects are selected making a total number of 33 subjects on which the final validation is performed. For each subject, BP measurements were performed simultaneously by two trained observers using mercury sphygmomanometers alternately with the Omron HEM-907 device. In all, 99 measurements were obtained for comparison. The difference between the BP value given by the device and that obtained by the two observers (mean of the two observers) was calculated for each measure. The difference between the two observers was -1 +/- 2 mmHg for the systolic BP (SBP) and for the diastolic BP (DBP). The Omron HEM-907 passed the first phase of the validation process. For the second phase, the average differences between the device and mercury sphygmomanometer readings were -1 +/- 7 and -5 +/- 6 mmHg for SBP and DBP respectively. Readings for the HEM-907 device differed by less than 5 mmHg for 61 of the systolic readings and 52 of the diastolic readings; by less than 10 mmHg for 85 of the systolic readings and 85 of the diastolic readings; and by less than 15 mmHg for 94 of the systolic readings and 96 of the diastolic readings. The Omron HEM-907 device passes the two phases of the international validation protocol.
    Blood Pressure Monitoring 09/2002; 7(4):237-41. · 1.80 Impact Factor
  • R Asmar, B Darne, M el Assaad, J Topouchian
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    ABSTRACT: In recent years, studies have shown that parameters derived from the arterial pressure wave other than systolic and diastolic blood pressure provide important information on cardiovascular status. Among these parameters, pulse pressure, arterial stiffness and heart rate have emerged as independent markers of cardiovascular risk in different populations. Although a number of studies have used casual measurements of these parameters in a clinic setting, others have focused on their assessment under ambulatory conditions. The pulse pressure represents the amplitude of the pressure wave signal (systolic minus diastolic blood pressure), higher pulse pressure values having been reported in patients possessing cardiovascular risk factors. Close associations between a high pulse pressure and several surrogate end-points have been described. Furthermore, epidemiological studies have shown that a high pulse pressure is an independent predictor of hard end-points in several populations. Arterial stiffness represents one of the major haemodynamic factors determining pulse pressure. Pulse wave velocity, measured from the initial upstroke of the pressure wave, constitutes an established index of arterial stiffness. Studies have reported stiffer arteries in patients with cardiovascular pathology even at an early stage of disease. Close correlations between arterial stiffness and several surrogate markers have been reported, and arterial stiffness and its changes have recently been shown to be an independent predictor of hard end-points in patients with a high cardiovascular risk. Methods to evaluate arterial stiffness under ambulatory conditions are emerging. Heart rate represents the frequency of the cyclical strain of the arterial wall, clinical studies having shown that ambulatory heart rate is correlated to several surrogate markers. A few epidemiological studies have analysed the value of ambulatory heart rate as an independent predictor of hard end-points, but their positive findings need to be confirmed. The analysis of the pressure wave thus allows the determination of several haemodynamic indices other than systolic and diastolic blood pressure. Pulse pressure, arterial stiffness and heart rate constitute other outcomes that may be useful as additional factors in risk assessment for future therapeutic decision-making.
    Blood Pressure Monitoring 01/2002; 6(6):329-33. · 1.80 Impact Factor
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    ABSTRACT: In clinical practice, diagnosis and follow-up of hypertension is based on blood pressure (BP) as measured by auscultatory method. BP is usually measured using a stethoscope to auscultate the Korotkoff sounds and mercury or an aneroid sphygmomanometer. However due to the lack of regulatory rules, the devices are rarely checked making the quality of the measures doubtful. To compare BP measured following the WHO recommendations, using 2 different devices: the mercury or aneroid sphygmomanometer used by the physician and a SECURUS manometer that has been calibrated just before the implementation of the study. The study was performed with 1694 French general practitioners. Every physician included 2 ambulatory patients: a newly diagnosed non-treated hypertensive patient and a treated hypertensive patient. The physician was asked to include the first patient of each category attending his office. BP was measured sequentially with the 2 devices in a random order. Collected data were socio-demographic parameters, cardiovascular risk factors, hypertension related diseases, drug treatment for hypertension and BP levels. Mean BPs differ by less than 1 mmHg between the 2 devices. However 10% of the treated hypertensive patients are not classified as having normalised BP values (BP < 140/90 mmHg) or high BP values, in the same way by the 2 devices. Mean absolute difference between the 2 devices is > 5 mmHg in 22% and 13% of the physicians for SBP and DBP respectively. This pilot study emphasises the need of BP measurements of good quality in clinical practice, because of the possible impact on the care of the patients and the related costs. Regulatory rules on the control of the devices might improve the quality of BP measurements.
    Archives des maladies du coeur et des vaisseaux 08/2001; 94(8):885-8. · 0.40 Impact Factor