The German Hypertension League (Deutsche Hochdruckliga) Quality Seal Protocol for blood pressure-measuring devices: 15-year experience and results from 105 devices for home blood pressure control.

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.

journal_name

Blood Press Monit

authors

Tholl U,Lüders S,Bramlage P,Dechend R,Eckert S,Mengden T,Nürnberger J,Sanner B,Anlauf M

doi

10.1097/MBP.0000000000000186

subject

Has Abstract

pub_date

2016-08-01 00:00:00

pages

197-205

issue

4

eissn

1359-5237

issn

1473-5725

journal_volume

21

pub_type

杂志文章
  • Dialysis-induced hypotension is associated with impaired aortic elasticity in patients undergoing chronic hemodialysis.

    abstract:BACKGROUND:The pathogenesis of dialysis-induced hypotension (DIH) is multifactorial and may include increased aortic stiffness. This study was undertaken to determine aortic elastic properties in patients undergoing hemodialysis with and without DIH, and to assess the effects of DIH on mortality. METHODS:Aortic stiffn...

    journal_title:Blood pressure monitoring

    pub_type: 杂志文章,多中心研究

    doi:10.1097/MBP.0b013e3282f13f75

    authors: Duman D,Demirtunc R,Erdogan B,Sahin GM,Karadag B

    更新日期:2008-04-01 00:00:00

  • Effects of the angiotensin II receptor blockers telmisartan versus valsartan in combination with hydrochlorothiazide: a large, confirmatory trial.

    abstract::In 2004-2005, the antihypertensive effects of telmisartan 80 mg versus valsartan 160 mg combined with hydrochlorothiazide 25 mg were assessed in a large placebo-controlled trial in patients with stages 1 and 2 hypertension and demonstrated that both agents were highly effective in lowering blood pressure (BP) compared...

    journal_title:Blood pressure monitoring

    pub_type: 杂志文章,随机对照试验

    doi:10.1097/MBP.0b013e3282f3859d

    authors: White WB,Murwin D,Chrysant SG,Koval SE,Davidai G,Guthrie R

    更新日期:2008-02-01 00:00:00

  • Automated device that complies with current guidelines for office blood pressure measurement: design and pilot application study of the Microlife WatchBP Office device.

    abstract:OBJECTIVE:Current guidelines for office blood pressure (BP) measurement recommend mercury devices, both arms measurement in the initial assessment and at least duplicate measurements at follow-up visits. This study presents the design and a pilot application study of an automated device that fulfils American, European,...

    journal_title:Blood pressure monitoring

    pub_type: 杂志文章

    doi:10.1097/MBP.0b013e3283057a84

    authors: Stergiou GS,Lin CW,Lin CM,Chang SL,Protogerou AD,Tzamouranis D,Nasothimiou E,Tan TM

    更新日期:2008-08-01 00:00:00

  • Impact of choosing the closest rather than the mean auscultatory blood pressure value on the European Society of Hypertension International Protocol device validation results.

    abstract:OBJECTIVE:When calculating the difference between alternating auscultatory reference standard (ARS) and the automated device-under-test (DUT) blood pressure (BP) measurements, the European Society of Hypertension International Protocol (ESH-IP) allows investigators to choose the closest ARS value to the DUT value, rath...

    journal_title:Blood pressure monitoring

    pub_type: 杂志文章

    doi:10.1097/MBP.0000000000000454

    authors: Padwal R,Wood PW,McLean D,Ringrose JS

    更新日期:2020-08-01 00:00:00

  • Blood pressure cuff comparability study.

    abstract:BACKGROUND:Manufacturer-supplied blood pressure (BP) cuffs are part of the automatic oscillometric BP devices algorithm. MATERIALS AND METHODS:This study assessed the differences in BP values using the Omron HEM 907-XL (Omron) device with two types of cuffs: the Baum cuff (BC) and the supplied Omron cuff (OC). A sampl...

    journal_title:Blood pressure monitoring

    pub_type: 杂志文章,随机对照试验

    doi:10.1097/MBP.0000000000000208

    authors: Ostchega Y,Nwankwo T,Zhang G,Chiappa M

    更新日期:2016-12-01 00:00:00

  • The impact of arm circumference on noninvasive oscillometric blood pressure referenced with intra-aortic blood pressure.

    abstract:OBJECTIVE:To investigate the influence of arm circumference (AC) on the brachial blood pressure (BP) measured with an adult cuff. PARTICIPANTS AND METHODS:This study included 208 patients (150 men, 61.0±8.0 years) for coronary angiography. Intra-aortic BP and noninvasive right brachial oscillometric BP (noninvasive BP...

    journal_title:Blood pressure monitoring

    pub_type: 杂志文章

    doi:10.1097/MBP.0000000000000141

    authors: Shangguan Q,Wu Y,Xu J,Su H,Li J,Hong K,Cheng X

    更新日期:2015-12-01 00:00:00

  • The effect of crossing legs on blood pressure.

    abstract:OBJECTIVE:To determine whether crossing of the legs at the knee or at the ankles during blood pressure measurement in sitting position has an effect on blood pressure. METHODS:One hundred and eleven patients, 60 women, mean age 52+/-17 years (19-80): 49 chronically treated hypertensives, 28 treated diabetics and 34 no...

    journal_title:Blood pressure monitoring

    pub_type: 杂志文章

    doi:10.1097/MBP.0b013e3280b083a7

    authors: Adiyaman A,Tosun N,Elving LD,Deinum J,Lenders JW,Thien T

    更新日期:2007-06-01 00:00:00

  • Differential effects of antihypertensive drugs on circadian rhythm in blood pressure from the chronobiological point of view.

    abstract::REVIEW IN DEPTH: The cardiovascular system is well organized in time. The blood pressure normally displays a circadian rhythm characterized by a nightly drop which, however, can be disturbed by disease. The 24 h blood pressure and its mechanisms of regulation are very dynamic and rhythmic processes. Ambulatory blood p...

    journal_title:Blood pressure monitoring

    pub_type: 杂志文章

    doi:

    authors: Lemmer B

    更新日期:1996-04-01 00:00:00

  • Comparison of the effects of two different teaching methods in blood pressure measurement training: a randomized controlled study.

    abstract:OBJECTIVE:To compare the effects of a high-fidelity simulator and conventional teaching model used during blood pressure measurement training on students' self-confidence, self-efficacy and anxiety levels. METHODS:A randomized controlled trial design was used. The study was conducted on 59 first-year nursing students ...

    journal_title:Blood pressure monitoring

    pub_type: 杂志文章,随机对照试验

    doi:10.1097/MBP.0000000000000401

    authors: Terzi B,Topbaş E,Bingöl G,Mavi Aydoğdu SG

    更新日期:2019-12-01 00:00:00

  • Validation of the A&D BP UA-651 device with a wide-range cuff for home blood pressure measurement according to the European Society of Hypertension International Protocol revision 2010.

    abstract::The aim of this study was to determine the accuracy of the A&D BP UA-651 device coupled to a wide-range cuff for home blood pressure (BP) measurement according to the International Protocol of the European Society of Hypertension. The device was evaluated in 33 patients. The mean age of the patients was 56.5±15.1 year...

    journal_title:Blood pressure monitoring

    pub_type: 杂志文章

    doi:10.1097/MBP.0000000000000100

    authors: Benetti E,Fania C,Palatini P

    更新日期:2015-06-01 00:00:00

  • Intense aerobic exercise lowers blood pressure in individuals with metabolic syndrome taking antihypertensive medicine.

    abstract:OBJECTIVE:There is a growing tendency for physicians to prescribe exercise in accordance with the 'exercise is medicine' global health initiative. However, the exercise-pharmacologic interactions for controlling blood pressure are not well described. Our purpose was to study whether angiotensin II receptor type 1 block...

    journal_title:Blood pressure monitoring

    pub_type: 杂志文章,随机对照试验

    doi:10.1097/MBP.0000000000000328

    authors: Ramirez-Jimenez M,Fernandez-Elias V,Morales-Palomo F,Ortega JF,Mora-Rodriguez R

    更新日期:2018-10-01 00:00:00

  • Left ventricular hypertrophy and preclinical impaired glucose tolerance and diabetes mellitus contribute to abnormal left ventricular diastolic function in hypertensive patients.

    abstract:BACKGROUND:Impaired left ventricular diastolic function is not uncommon in patients with either diabetes mellitus or hypertension. This study was carried out to assess the contribution of left ventricular hypertrophy, high blood pressure, preclinical impaired glucose tolerance and diabetes mellitus to left ventricular ...

    journal_title:Blood pressure monitoring

    pub_type: 杂志文章

    doi:10.1097/01.mbp.0000172710.82287.36

    authors: Salmasi AM,Rawlins S,Dancy M

    更新日期:2005-10-01 00:00:00

  • Ambulatory blood pressure monitoring in pediatric end-stage renal disease: chronic dialysis and transplantation.

    abstract::Hypertension is highly prevalent in pediatric patients with end-stage renal disease (ESRD). Ambulatory blood pressure monitoring (ABPM) has been used to characterize the altered circadian blood pressure patterns in ESRD in order to improve our understanding of the blood pressure dysregulation that occurs in these chil...

    journal_title:Blood pressure monitoring

    pub_type: 杂志文章,评审

    doi:

    authors: Sorof JM

    更新日期:1999-06-01 00:00:00

  • Comparison of central blood pressure devices on the basis of a modified protocol of the European Society of Hypertension: application to the Centron cBP301.

    abstract:OBJECTIVES:Central blood pressure (cBP) and pulse pressure amplification (PPA) are receiving renewed interest with the increase in the availability of noninvasive techniques that enable its measurement. However, to date, there is no standardized protocol to validate their accuracy. Although invasive comparison seems in...

    journal_title:Blood pressure monitoring

    pub_type: 杂志文章

    doi:10.1097/MBP.0000000000000028

    authors: Agnoletti D,Millasseau S,Topouchian J,Safar ME,Blacher J

    更新日期:2014-04-01 00:00:00

  • Does the accuracy of blood pressure measurement correlate with hearing loss of the observer?

    abstract:OBJECTIVE:The auscultatory method is influenced by the hearing level of the observers. If the observer has hearing loss, it is possible to measure blood pressure inaccurately by misreading the Korotkoff sounds at systolic blood pressure (SBP) and diastolic blood pressure (DBP). Because of the potential clinical problem...

    journal_title:Blood pressure monitoring

    pub_type: 杂志文章

    doi:10.1097/MBP.0000000000000016

    authors: Song S,Lee J,Chee Y,Jang DP,Kim IY

    更新日期:2014-02-01 00:00:00

  • Adequacy of validation of wide-range cuffs used with home blood pressure monitors: a systematic review.

    abstract:OBJECTIVES:Wide-range 'one-size-fits-all' blood pressure (BP) cuffs are commonly sold with home BP monitors. Assessment of the accuracy of these cuffs is important because they do not adhere to the basic principles of proper cuffing. The aim of this systematic review was to review the published validation data evaluati...

    journal_title:Blood pressure monitoring

    pub_type: 杂志文章

    doi:10.1097/MBP.0000000000000344

    authors: Sprague E,Padwal RS

    更新日期:2018-10-01 00:00:00

  • Comparison of two automated sphygmomanometers for use in the office setting.

    abstract:OBJECTIVE:To compare readings obtained using two automated blood pressure (BP) recording devices, BpTRU and Omron 907, in a clinical setting. METHODS:Two series of 50 patients attending a hypertension unit for 24-h ambulatory BP monitoring had BP recorded either every 1 or every 2 min using BpTRU and Omron 907 devices...

    journal_title:Blood pressure monitoring

    pub_type: 杂志文章

    doi:10.1097/MBP.0b013e32831e314f

    authors: Myers MG,Valdivieso M,Kiss A,Tobe SW

    更新日期:2009-02-01 00:00:00

  • Rationale and design of HOMED-BP Study: hypertension objective treatment based on measurement by electrical devices of blood pressure study.

    abstract:BACKGROUND:How far should blood pressure (BP) be lowered to achieve the greatest reduction in the risk of cardiovascular disease? Although a few trials have tried to answer this question, they failed to convincingly establish an optimal target BP level, in part because of poor reproducibility and the wide variability o...

    journal_title:Blood pressure monitoring

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1097/00126097-200202000-00016

    authors: Fujiwara T,Nishimura T,Ohkuko T,Imai Y,HOMED-BP Study Group.

    更新日期:2002-02-01 00:00:00

  • Methods of data analysis of ambulatory blood pressure monitoring in clinical trials.

    abstract::The objectives of the analysis are to compare the blood pressure levels at different phases of the trial and to be sure that the effect will continue until the next dose. There are problems before the analysis for which consensus is necessary. If the overall 24 h study is the first generally recognized stage, it is di...

    journal_title:Blood pressure monitoring

    pub_type: 杂志文章

    doi:

    authors: de Gaudemaris R,Chau NP

    更新日期:1996-06-01 00:00:00

  • An extended validation of the ScottCare 320 ambulatory blood pressure monitor: recommendations for clinical application.

    abstract:OBJECTIVES:The purpose of this study was to validate the ScottCare 320 ambulatory blood pressure monitor (ABPM) using both group-level and individual-level validation procedures. The group-level validation followed a modified protocol of the European Hypertension Society's validation protocol. The individual-level vali...

    journal_title:Blood pressure monitoring

    pub_type: 临床试验,杂志文章

    doi:10.1097/MBP.0b013e32835f4fc7

    authors: Zawadzki MJ,Vandekar L,Smyth JM,Haas D,Gerin W

    更新日期:2013-06-01 00:00:00

  • Conventional and ambulatory measurements of blood pressure in old patients with isolated systolic hypertension: baseline observations in the Syst-Eur trial.

    abstract::OBJECTIVES: To compare clinic and am measurements of blood pressure in old patients with isolated systolic hypertension and their reproducibilities. PATIENTS: In total 610 patients aged >/= 60 years with isolated systolic hypertension detected by clinic measurement were monitored during the placebo run-in phase of the...

    journal_title:Blood pressure monitoring

    pub_type: 杂志文章

    doi:

    authors: Emelianov D,Thijs L,Staessen JA,Celis H,Clement D,Davidson C,Gasowski J,Gil-Extremera B,Fogari R,Jääskivi M,Lehtonen A,Nedogoda S,O'Brien E,Palatini P,Parati G,Salvetti A,Vanhanen H,Webster J,Fagard R

    更新日期:1998-06-01 00:00:00

  • The Maxi Stabil 3: validation of an aneroid device according to a modified British Hypertension Society protocol.

    abstract:BACKGROUND:Measuring blood pressure with mercury-independent alternatives is rapidly gaining attention. Mercury will be phased out of clinical use as a result of environmental, health and safety concerns and it is of vital importance that any alternative to mercury has to be of a recognized standard. We assessed the ac...

    journal_title:Blood pressure monitoring

    pub_type: 杂志文章

    doi:10.1097/00126097-200304000-00005

    authors: Reinders A,Jones CR,Cuckson AC,Shennan AH

    更新日期:2003-04-01 00:00:00

  • Validation of the YuWell YE680B upper-arm blood pressure monitor in adults according to the ANSI/AAMI/ISO 81060-2: 2013 standard.

    abstract:OBJECTIVE:To evaluate the accuracy of the YuWell YE680B oscillometric upper-arm blood pressure monitor for clinic and home blood pressure measurements in adults according to the American National Standards Institute/the Association for the Advancement of Medical Instrumentation/International Organization for Standardiz...

    journal_title:Blood pressure monitoring

    pub_type: 杂志文章

    doi:10.1097/MBP.0000000000000405

    authors: Huang JF,Zhang W,Li Y,Wang JG

    更新日期:2019-12-01 00:00:00

  • Repeatability of blood pressure measurements during treadmill exercise.

    abstract:OBJECTIVE:Blood pressure measurements during exercise are difficult to obtain but are used widely in clinical practice. The objective of this study was to investigate the repeatability of blood pressure measurements and gas exchange parameters during treadmill exercise. METHODS:Participants were 10 healthy and nonsmok...

    journal_title:Blood pressure monitoring

    pub_type: 临床试验,杂志文章

    doi:10.1097/MBP.0b013e328351de5c

    authors: Instebø A,Helgheim V,Greve G

    更新日期:2012-04-01 00:00:00

  • A strategy utilizing ambulatory monitoring and home and clinic blood pressure measurements to optimize the safety evaluation of noncardiovascular drugs with potential for hemodynamic effects: a report from the SYNERGY trial.

    abstract:OBJECTIVE:The aim of this study was to perform a blood pressure (BP) safety evaluation in patients with an overactive bladder receiving solifenacin (an antimuscarinic agent), mirabegron (a β3-adrenoceptor agonist), or both compared with placebo in the SYNERGY trial. PATIENTS AND METHODS:Patients were randomized to rec...

    journal_title:Blood pressure monitoring

    pub_type: 杂志文章,多中心研究,随机对照试验

    doi:10.1097/MBP.0000000000000320

    authors: Weber MA,Chapple CR,Gratzke C,Herschorn S,Robinson D,Frankel JM,Ridder AM,Stoelzel M,Paireddy A,van Maanen R,White WB

    更新日期:2018-06-01 00:00:00

  • Relationship between noninvasive and invasive blood pressure values in end-stage renal disease patients on dialysis.

    abstract:BACKGROUND:End-stage renal disease (ESRD) is complicated by high blood pressure (BP) and severe atherosclerosis, which may lead to different values of BP measured by invasive and noninvasive methods. However, the differences in BP values between these two methods and their possible mechanisms in ESRD have not been inve...

    journal_title:Blood pressure monitoring

    pub_type: 杂志文章

    doi:10.1097/MBP.0000000000000026

    authors: Chen Y,Zhu Y,Chen C,Chen X,Pan H,Chen S,Tan X

    更新日期:2014-04-01 00:00:00

  • Application of Nexfin noninvasive beat-to-beat arterial blood pressure monitoring in autonomic function testing.

    abstract:OBJECTIVE:Evaluation of autonomic function responses is increasingly important for risk prediction and hemodynamic evaluation in the ambulant and perioperative setting, but requires a noninvasive arterial blood pressure measurement device. This study describes whether a novel noninvasive beat-to-beat arterial blood pre...

    journal_title:Blood pressure monitoring

    pub_type: 杂志文章

    doi:10.1097/MBP.0b013e32834b4431

    authors: Sipkens LM,Treskes K,Ariese-Beldman K,Veerman DP,Boer C

    更新日期:2011-10-01 00:00:00

  • Accuracy of the WatchBP O3 device for ambulatory blood pressure monitoring according to the new criteria of the ISO81060-2 2018 protocol.

    abstract:OBJECTIVE:The aim of the study was to determine the accuracy of the Microlife WatchBP O3 monitor for ambulatory blood pressure (BP) measurement according to the new ISO81060-2 2018 protocol. METHODS:The WatchBP O3 was first tested in 97 subjects from the general population (mean age, 71.3 years; 48 men) using four cuf...

    journal_title:Blood pressure monitoring

    pub_type: 杂志文章

    doi:10.1097/MBP.0000000000000459

    authors: Fania C,Lazzaretto I,Fontana U,Palatini P

    更新日期:2020-10-01 00:00:00

  • Validation of the A&D wrist-cuff UB-511 (UB-512) device for self-measurement of blood pressure.

    abstract:OBJECTIVES:To determine the accuracy of the A&D UB-511 (UB-512) oscillometric wrist-cuff device for self-measurement of blood pressure, the only difference between the two devices being the size of storage memory. METHODS:Device evaluation was performed according to the modified British Hypertension Society protocol r...

    journal_title:Blood pressure monitoring

    pub_type: 杂志文章,随机对照试验

    doi:10.1097/01.mbp.0000217995.12215.f2

    authors: Angeli F,Sardone M,Angeli E,Repaci S,Gattobigio R,Verdecchia P

    更新日期:2006-12-01 00:00:00

  • Potential hypotensive effects of Umezu polyphenols: a 14-week community-based, double-masked and placebo-controlled trial.

    abstract:OBJECTIVE:To evaluate blood pressure (BP)-lowering effects of Umezu polyphenols, polyphenols contained in Japanese plums, in a community-based sample by double-masked and placebo-controlled design. METHODS:Seventy-two Japanese community-dwellers who were interested in prevention or control of their BP (preferably high...

    journal_title:Blood pressure monitoring

    pub_type: 杂志文章,随机对照试验

    doi:10.1097/MBP.0000000000000476

    authors: Takemura S,Yoshimasu K,Tsuno K,Kuroda M,Kishida K,Mitani T,Miyashita K

    更新日期:2020-12-01 00:00:00