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Guiding Hypertension Management Using Different Blood Pressure Monitoring Strategies (GYMNs study): comparison of three different blood pressure measurement methods: study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Home blood pressure (BP) and unattended automated BP (uAOBP) monitoring have been recommended by guidelines for the care of hypertensive subjects. However, BP measurements in the peripheral arteries cannot serve as direct substitutes for their central counterparts. Moreover, the comparative effectiveness and safety of BP-guided strategies using these BP measuring devices have never been evaluated. METHODS/DESIGN:Patients with uncontrolled or newly diagnosed hypertension aged 20-90?years will be recruited via outpatient clinics and allocated into three arms by stratified randomization (baseline systolic BP 130-155?mmHg and 155-180?mmHg): home BP, uAOBP, and central BP-guided treatment. At each scheduled visit to the clinic, a patient's BP will be measured by each of the three methods of measuring BP. The blood pressure from three different methods will be confirmed available at each visit. Patients and physicians will be blinded to the allocated interventions because they will use measured BP values in the clinic through a standardized report format. A common BP target for systolic blood pressure (SBP) of 130?mmHg is adopted for these BP-guided strategies. The primary outcome is the change of 24-h mean ambulatory SBP at 3?months. A key secondary outcome is to determine the percentage achieving their target BPs at 3?months and the decrease of left ventricular mass at 12?months. DISCUSSION:To our knowledge, this is the first prospective double-blind randomized controlled trial to assess the optimal guiding strategy for hypertension. It will help to define which BP monitoring method is the most effective for guiding the clinical management of hypertension. It will provide good evidence to support future guideline recommendations for BP monitoring devices. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03578848 . Registered on 4 June 2018.

SUBMITTER: Cheng HM

PROVIDER: S-EPMC6511145 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Guiding Hypertension Management Using Different Blood Pressure Monitoring Strategies (GYMNs study): comparison of three different blood pressure measurement methods: study protocol for a randomized controlled trial.

Cheng Hao-Min HM Sung Shih-Hsien SH Chen Chen-Huan CH Yu Wen-Chung WC Yang Shu-Mei SM Guo Chao-Yu CY Chuang Shao-Yuan SY Chiang Chern-En CE

Trials 20190510 1

<h4>Background</h4>Home blood pressure (BP) and unattended automated BP (uAOBP) monitoring have been recommended by guidelines for the care of hypertensive subjects. However, BP measurements in the peripheral arteries cannot serve as direct substitutes for their central counterparts. Moreover, the comparative effectiveness and safety of BP-guided strategies using these BP measuring devices have never been evaluated.<h4>Methods/design</h4>Patients with uncontrolled or newly diagnosed hypertension ...[more]

PMID: 31077229

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Project description:Minimal clinical research has investigated the significance of different blood pressure monitoring techniques in the ICU and whether systolic vs. mean blood pressures should be targeted in therapeutic protocols and in defining clinical study cohorts. The objectives of this study are to compare real-world invasive arterial blood pressure with noninvasive blood pressure, and to determine if differences between the two techniques have clinical implications.We conducted a retrospective study comparing invasive arterial blood pressure and noninvasive blood pressure measurements using a large ICU database. We performed pairwise comparison between concurrent measures of invasive arterial blood pressure and noninvasive blood pressure. We studied the association of systolic and mean invasive arterial blood pressure and noninvasive blood pressure with acute kidney injury, and with ICU mortality.Adult intensive care units at a tertiary care hospital.Adult patients admitted to intensive care units between 2001 and 2007.None.Pairwise analysis of 27,022 simultaneously measured invasive arterial blood pressure/noninvasive blood pressure pairs indicated that noninvasive blood pressure overestimated systolic invasive arterial blood pressure during hypotension. Analysis of acute kidney injury and ICU mortality involved 1,633 and 4,957 patients, respectively. Our results indicated that hypotensive systolic noninvasive blood pressure readings were associated with a higher acute kidney injury prevalence (p = 0.008) and ICU mortality (p < 0.001) than systolic invasive arterial blood pressure in the same range (?70 mm Hg). Noninvasive blood pressure and invasive arterial blood pressure mean arterial pressures showed better agreement; acute kidney injury prevalence (p = 0.28) and ICU mortality (p = 0.76) associated with hypotensive mean arterial pressure readings (?60 mm Hg) were independent of measurement technique.Clinically significant discrepancies exist between invasive and noninvasive systolic blood pressure measurements during hypotension. Mean blood pressure from both techniques may be interpreted in a consistent manner in assessing patients' prognosis. Our results suggest that mean rather than systolic blood pressure is the preferred metric in the ICU to guide therapy.

Project description:ObjectiveTo assess the feasibility of using a blood pressure (BP) self-measurement kiosk-a solid-cuff sphygmomanometer combined with technology to integrate the BP readings into patient electronic medical records- to improve hypertension detection.DesignA concurrent mixed-methods feasibility study incorporating observational and qualitative interview components.SettingTwo English general practitioner (GP) surgeries.ParticipantsAdult patients registered at participating surgeries. Staff working at these sites.InterventionsBP self-measurement kiosks were placed in the waiting rooms for a 12-month period between 2015 and 2016 and compared with a 12-month control period prior to installation.Outcome measures(1) The number of patients using the kiosk and agreeing to transfer of their data into their electronic medical records; (2) the cost of using a kiosk compared with GP/practice nurse BP screening; (3) qualitative themes regarding use of the equipment.ResultsOut of 15?624 eligible patients, only 186 (1.2%, 95% CI 1.0% to 1.4%) successfully used the kiosk to directly transfer a BP reading into their medical record. For a considerable portion of the intervention period, no readings were transferred, possibly indicating technical problems with the transfer link. A comparison of costs suggests that at least 52.6% of eligible patients would need to self-screen in order to bring costs below that of screening by GPs and practice nurses. Qualitative interviews confirmed that both patients and staff experienced technical difficulties, and used alternative methods to enter BP results into the medical record.ConclusionsWhile interviewees were generally positive about checking BP in the waiting room, the electronic transfer system as tested was neither robust, effective nor likely to be a cost-effective approach, thus may not be appropriate for a primary care environment. Since most of the cost of a kiosk system lies in the transfer mechanism, a solid-cuff sphygmomanometer and manual entry of results may be a suitable alternative.

Project description:ImportanceAutomated office blood pressure (AOBP) measurement involves recording several blood pressure (BP) readings using a fully automated oscillometric sphygmomanometer with the patient resting alone in a quiet place. Although several studies have shown AOBP measurement to be more accurate than routine office BP measurement and not subject to a "white coat effect," the cumulative evidence has not yet been systematically reviewed.ObjectiveTo perform a systematic review and meta-analysis to examine the association between AOBP and office BP readings measured in routine clinical practice and in research studies, and ambulatory BP recorded during awake hours, as the latter is a standard for predicting future cardiovascular events.Data sourcesThe MEDLINE, Embase, and Cochrane Library were searched from 2003 to April 25, 2018.Study selectionStudies on systolic and diastolic BP measurement by AOBP in comparison with awake ambulatory BP, routine office BP, and research BP measurements were included if they contained 30 patients or more.Data extraction and synthesisStudy characteristics were abstracted independently and random effects meta-analyses and meta-regressions were conducted.Main outcomes and measuresPooled mean differences (95% CI) of systolic and diastolic BP between types of BP measurement.ResultsData were compiled from 31 articles comprising 9279 participants (4736 men and 4543 women). In samples with systolic AOBP of 130 mm Hg or more, routine office and research systolic BP readings were substantially higher than AOBP readings, with a pooled mean difference of 14.5 mm Hg (95% CI, 11.8-17.2 mm Hg; n = 9; I2 = 94.3%; P < .001) for routine office systolic BP readings and 7.0 mm Hg (95% CI, 4.9-9.1 mm Hg; n = 9; I2 = 85.7%; P < .001) for research systolic BP readings. Systolic awake ambulatory BP and AOBP readings were similar, with a pooled mean difference of 0.3 mm Hg (95% CI, -1.1 to 1.7 mm Hg; n = 19; I2 = 90%; P < .001).Conclusions and relevanceAutomated office blood pressure readings, only when recorded properly with the patient sitting alone in a quiet place, are more accurate than office BP readings in routine clinical practice and are similar to awake ambulatory BP readings, with mean AOBP being devoid of any white coat effect. There has been some reluctance among physicians to adopt this technique because of uncertainty about its advantages compared with more traditional methods of recording BP during an office visit. Based on the evidence, AOBP should now be the preferred method for recording BP in routine clinical practice.

Project description:IntroductionPeople of South Asian, African-Caribbean and Irish ethnicity are known to have worse cardiovascular outcomes than those from the white British group. While the reasons underpinning this are complex, the effect of hypertension is both significant and modifiable. In recent years, there has been increasing interest in and uptake of 'out-of-office' methods for blood pressure (BP) monitoring. However, guidance in this area has been largely based on research among the white population. This study aims to answer the following questions: (1) How often and in what ways does blood pressure (BP) monitoring occur and how does this differ between white and the above minority ethnic populations. (2) Are the thresholds for diagnosis of hypertension, and treatment targets in hypertension comparable for white British and minority ethnic populations using different measurement modalities: office blood pressure, ambulatory BP monitoring and home monitoring? (3) What preferences for BP measurement do people from white and minority ethnic populations have?Methods and analysisA mixed methods approach will be used including the following: (1) A postal survey sent to 8000 hypertensive and not-known-to-be-hypertensive people from all four ethnic groups will determine current patterns of BP monitoring. (2) A validation study will compare BP measurement by ambulatory monitoring with office standard measurement, office research measurement and home monitoring in 200 people from each of the ethnic groups concerned. (3) Focus groups organised by ethnicity and gender will gather qualitative data regarding patient preferences for and experiences of BP measurement in each of the given modalities. The data collected from these phases will be analysed appropriately in order to answer the above research questions.Ethics and disseminationEthical approval has been gained from the Black Country Research Ethics Committee: Ref 09/H1202/114. The results of this work will be disseminated via journal publication and conference presentation.

Dataset Information

Guiding Hypertension Management Using Different Blood Pressure Monitoring Strategies (GYMNs study): comparison of three different blood pressure measurement methods: study protocol for a randomized controlled trial.

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Guiding Hypertension Management Using Different Blood Pressure Monitoring Strategies (GYMNs study): comparison of three different blood pressure measurement methods: study protocol for a randomized controlled trial.

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