Objective To systematically review studies quantifying the associations of long term (clinic), mid-term (home), and short term (ambulatory) variability in blood pressure, independent of mean blood ...pressure, with cardiovascular disease events and mortality.Data sources Medline, Embase, Cinahl, and Web of Science, searched to 15 February 2016 for full text articles in English.Eligibility criteria for study selection Prospective cohort studies or clinical trials in adults, except those in patients receiving haemodialysis, where the condition may directly impact blood pressure variability. Standardised hazard ratios were extracted and, if there was little risk of confounding, combined using random effects meta-analysis in main analyses. Outcomes included all cause and cardiovascular disease mortality and cardiovascular disease events. Measures of variability included standard deviation, coefficient of variation, variation independent of mean, and average real variability, but not night dipping or day-night variation.Results 41 papers representing 19 observational cohort studies and 17 clinical trial cohorts, comprising 46 separate analyses were identified. Long term variability in blood pressure was studied in 24 papers, mid-term in four, and short-term in 15 (two studied both long term and short term variability). Results from 23 analyses were excluded from main analyses owing to high risks of confounding. Increased long term variability in systolic blood pressure was associated with risk of all cause mortality (hazard ratio 1.15, 95% confidence interval 1.09 to 1.22), cardiovascular disease mortality (1.18, 1.09 to 1.28), cardiovascular disease events (1.18, 1.07 to 1.30), coronary heart disease (1.10, 1.04 to 1.16), and stroke (1.15, 1.04 to 1.27). Increased mid-term and short term variability in daytime systolic blood pressure were also associated with all cause mortality (1.15, 1.06 to 1.26 and 1.10, 1.04 to 1.16, respectively).Conclusions Long term variability in blood pressure is associated with cardiovascular and mortality outcomes, over and above the effect of mean blood pressure. Associations are similar in magnitude to those of cholesterol measures with cardiovascular disease. Limited data for mid-term and short term variability showed similar associations. Future work should focus on the clinical implications of assessment of variability in blood pressure and avoid the common confounding pitfalls observed to date.Systematic review registration PROSPERO CRD42014015695.
AbstractObjectiveTo assess the associations between statins and adverse events in primary prevention of cardiovascular disease and to examine how the associations vary by type and dosage of ...statins.DesignSystematic review and meta-analysis.Data sourcesStudies were identified from previous systematic reviews and searched in Medline, Embase, and the Cochrane Central Register of Controlled Trials, up to August 2020.Review methodsRandomised controlled trials in adults without a history of cardiovascular disease that compared statins with non-statin controls or compared different types or dosages of statins were included.Main outcome measuresPrimary outcomes were common adverse events: self-reported muscle symptoms, clinically confirmed muscle disorders, liver dysfunction, renal insufficiency, diabetes, and eye conditions. Secondary outcomes included myocardial infarction, stroke, and death from cardiovascular disease as measures of efficacy.Data synthesisA pairwise meta-analysis was conducted to calculate odds ratios and 95% confidence intervals for each outcome between statins and non-statin controls, and the absolute risk difference in the number of events per 10 000 patients treated for a year was estimated. A network meta-analysis was performed to compare the adverse effects of different types of statins. An Emax model based meta-analysis was used to examine the dose-response relationships of the adverse effects of each statin.Results62 trials were included, with 120 456 participants followed up for an average of 3.9 years. Statins were associated with an increased risk of self-reported muscle symptoms (21 trials, odds ratio 1.06 (95% confidence interval 1.01 to 1.13); absolute risk difference 15 (95% confidence interval 1 to 29)), liver dysfunction (21 trials, odds ratio 1.33 (1.12 to 1.58); absolute risk difference 8 (3 to 14)), renal insufficiency (eight trials, odds ratio 1.14 (1.01 to 1.28); absolute risk difference 12 (1 to 24)), and eye conditions (six trials, odds ratio 1.23 (1.04 to 1.47); absolute risk difference 14 (2 to 29)) but were not associated with clinically confirmed muscle disorders or diabetes. The increased risks did not outweigh the reduction in the risk of major cardiovascular events. Atorvastatin, lovastatin, and rosuvastatin were individually associated with some adverse events, but few significant differences were found between types of statins. An Emax dose-response relationship was identified for the effect of atorvastatin on liver dysfunction, but the dose-response relationships for the other statins and adverse effects were inconclusive.ConclusionsFor primary prevention of cardiovascular disease, the risk of adverse events attributable to statins was low and did not outweigh their efficacy in preventing cardiovascular disease, suggesting that the benefit-to-harm balance of statins is generally favourable. Evidence to support tailoring the type or dosage of statins to account for safety concerns before starting treatment was limited.Systematic review registrationPROSPERO CRD42020169955.
Self-monitoring of blood pressure (BP) appears to reduce BP in hypertension but important questions remain regarding effective implementation and which groups may benefit most. This individual ...patient data (IPD) meta-analysis was performed to better understand the effectiveness of BP self-monitoring to lower BP and control hypertension.
Medline, Embase, and the Cochrane Library were searched for randomised trials comparing self-monitoring to no self-monitoring in hypertensive patients (June 2016). Two reviewers independently assessed articles for eligibility and the authors of eligible trials were approached requesting IPD. Of 2,846 articles in the initial search, 36 were eligible. IPD were provided from 25 trials, including 1 unpublished study. Data for the primary outcomes-change in mean clinic or ambulatory BP and proportion controlled below target at 12 months-were available from 15/19 possible studies (7,138/8,292 86% of randomised participants). Overall, self-monitoring was associated with reduced clinic systolic blood pressure (sBP) compared to usual care at 12 months (-3.2 mmHg, 95% CI -4.9, -1.6 mmHg). However, this effect was strongly influenced by the intensity of co-intervention ranging from no effect with self-monitoring alone (-1.0 mmHg -3.3, 1.2), to a 6.1 mmHg (-9.0, -3.2) reduction when monitoring was combined with intensive support. Self-monitoring was most effective in those with fewer antihypertensive medications and higher baseline sBP up to 170 mmHg. No differences in efficacy were seen by sex or by most comorbidities. Ambulatory BP data at 12 months were available from 4 trials (1,478 patients), which assessed self-monitoring with little or no co-intervention. There was no association between self-monitoring and either lower clinic or ambulatory sBP in this group (clinic -0.2 mmHg -2.2, 1.8; ambulatory 1.1 mmHg -0.3, 2.5). Results for diastolic blood pressure (dBP) were similar. The main limitation of this work was that significant heterogeneity remained. This was at least in part due to different inclusion criteria, self-monitoring regimes, and target BPs in included studies.
Self-monitoring alone is not associated with lower BP or better control, but in conjunction with co-interventions (including systematic medication titration by doctors, pharmacists, or patients; education; or lifestyle counselling) leads to clinically significant BP reduction which persists for at least 12 months. The implementation of self-monitoring in hypertension should be accompanied by such co-interventions.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
BACKGROUND
Self-monitoring of blood pressure (SMBP) can contribute to reduced blood pressure in people with hypertension. Potential mediators include increased medication, improved adherence, and ...changes in lifestyle factors including dietary change and increased physical activity. The objective of this review was to determine the effect of SMBP on medication adherence, medication persistence, and lifestyle factors in people with hypertension.
METHODS
Electronic bibliographic databases were searched through February 2014 to identify randomized controlled trials that compared SMBP to control/usual care in ambulatory hypertensive patients and reported medication or nonpharmacologic treatment adherence measures.
RESULTS
Twenty-eight trials with 7,021 participants fulfilled the inclusion criteria. Medication adherence was assessed in 25 trials (89%), dietary outcomes in 8 (29%), physical activity in 6 (21%), and medication persistence in 1 (4%). Blood pressure was assessed in 26 studies (93%). Follow-up ranged from 2 weeks to 12 months. Pooled results of 13 studies demonstrated a small but significant overall effect on medication adherence in favor of SMBP interventions (standardized mean difference 0.21, 95% CI 0.08, 0.34), with moderate heterogeneity (I
2 = 43%). Standardized mean difference was used to express the size of intervention effect in each study relative to the variability observed, and was used to combine the results of studies where different measures of medication adherence were used. Where SMBP interventions had a significant effect on lifestyle factor change, the effect was unlikely to be clinically significant. Pooled results of 11 studies demonstrate a significant overall effect on diastolic blood pressure in favor of SMBP (weighted mean difference −2.02, 95% CI −2.93, −1.11), with low heterogeneity (I
2 = 0%). A test for subgroup differences showed no difference when studies were grouped according to whether medication adherence was significantly improved or not.
CONCLUSIONS
SMBP may contribute to improvements in medication adherence in hypertensives. However, evidence for the effect of SMBP on lifestyle change and medication persistence is scarce, of poor quality, and suggests little clinically relevant benefit.
Summary Background Control of blood pressure is a key component of cardiovascular disease prevention, but is difficult to achieve and until recently has been the sole preserve of health ...professionals. This study assessed whether self-management by people with poorly controlled hypertension resulted in better blood pressure control compared with usual care. Methods This randomised controlled trial was undertaken in 24 general practices in the UK. Patients aged 35–85 years were eligible for enrolment if they had blood pressure more than 140/90 mm Hg despite antihypertensive treatment and were willing to self-manage their hypertension. Participants were randomly assigned in a 1:1 ratio to self-management, consisting of self-monitoring of blood pressure and self-titration of antihypertensive drugs, combined with telemonitoring of home blood pressure measurements or to usual care. Randomisation was done by use of a central web-based system and was stratified by general practice with minimisation for sex, baseline systolic blood pressure, and presence or absence of diabetes or chronic kidney disease. Neither participants nor investigators were masked to group assignment. The primary endpoint was change in mean systolic blood pressure between baseline and each follow-up point (6 months and 12 months). All randomised patients who attended follow-up visits at 6 months and 12 months and had complete data for the primary outcome were included in the analysis, without imputation for missing data. This study is registered as an International Standard Randomised Controlled Trial , number ISRCTN17585681. Findings 527 participants were randomly assigned to self-management (n=263) or control (n=264), of whom 480 (91%; self-management, n=234; control, n=246) were included in the primary analysis. Mean systolic blood pressure decreased by 12·9 mm Hg (95% CI 10·4–15·5) from baseline to 6 months in the self-management group and by 9·2 mm Hg (6·7–11·8) in the control group (difference between groups 3·7 mm Hg, 0·8–6·6; p=0·013). From baseline to 12 months, systolic blood pressure decreased by 17·6 mm Hg (14·9–20·3) in the self-management group and by 12·2 mm Hg (9·5–14·9) in the control group (difference between groups 5·4 mm Hg, 2·4–8·5; p=0·0004). Frequency of most side-effects did not differ between groups, apart from leg swelling (self-management, 74 patients 32%; control, 55 patients 22%; p=0·022). Interpretation Self-management of hypertension in combination with telemonitoring of blood pressure measurements represents an important new addition to control of hypertension in primary care. Funding Department of Health Policy Research Programme, National Coordinating Centre for Research Capacity Development, and Midlands Research Practices Consortium.
For behaviour-change interventions to be successful they must be acceptable to users and overcome barriers to behaviour change. The Person-Based Approach can help to optimise interventions to ...maximise acceptability and engagement. This article presents a novel, efficient and systematic method that can be used as part of the Person-Based Approach to rapidly analyse data from development studies to inform intervention modifications. We describe how we used this approach to optimise a digital intervention for patients with hypertension (HOME BP), which aims to implement medication and lifestyle changes to optimise blood pressure control.
In study 1, hypertensive patients (N = 12) each participated in three think-aloud interviews, providing feedback on a prototype of HOME BP. In study 2 patients (N = 11) used HOME BP for three weeks and were then interviewed about their experiences. Studies 1 and 2 were used to identify detailed changes to the intervention content and potential barriers to engagement with HOME BP. In study 3 (N = 7) we interviewed hypertensive patients who were not interested in using an intervention like HOME BP to identify potential barriers to uptake, which informed modifications to our recruitment materials. Analysis in all three studies involved detailed tabulation of patient data and comparison to our modification criteria.
Studies 1 and 2 indicated that the HOME BP procedures were generally viewed as acceptable and feasible, but also highlighted concerns about monitoring blood pressure correctly at home and making medication changes remotely. Patients in study 3 had additional concerns about the safety and security of the intervention. Modifications improved the acceptability of the intervention and recruitment materials.
This paper provides a detailed illustration of how to use the Person-Based Approach to refine a digital intervention for hypertension. The novel, efficient approach to analysis and criteria for deciding when to implement intervention modifications described here may be useful to others developing interventions.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
In the past 30 years, several organizations have developed protocols for clinical validation of blood pressure measuring devices. An international initiative was recently launched by the US ...Association for the Advancement of Medical Instrumentation (AAMI), the European Society of Hypertension Working Group on Blood Pressure Monitoring (ESH) and the International Organization for Standardization (ISO), aiming to reach consensus on a universal AAMI/ESH/ISO validation standard. The purpose of this statement by the ESH Working Group on Blood Pressure Monitoring is to provide practical guidance for investigators performing validation studies according to the AAMI/ESH/ISO Universal Standard (ISO 81060–2:2018), to ensure that its stipulations are meticulously implemented and data are fully reported. Thus, this statement providesa list of key recommendations for validation studies of intermittent non-invasive automated blood pressure measuring devices according to the AAMI/ESH/ISO Universal Standard; practical stepwise guidance for researchers performing these validation studies; a checklist for authors and reviewers of such studies; an example of a complete validation study report.
Telemedicine allows the remote exchange of medical data between patients and healthcare professionals. It is used to increase patients’ access to care and provide effective healthcare services at a ...distance. During the recent coronavirus disease 2019 (COVID-19) pandemic, telemedicine has thrived and emerged worldwide as an indispensable resource to improve the management of isolated patients due to lockdown or shielding, including those with hypertension. The best proposed healthcare model for telemedicine in hypertension management should include remote monitoring and transmission of vital signs (notably blood pressure) and medication adherence plus education on lifestyle and risk factors, with video consultation as an option. The use of mixed automated feedback services with supervision of a multidisciplinary clinical team (physician, nurse, or pharmacist) is the ideal approach. The indications include screening for suspected hypertension, management of older adults, medically underserved people, high-risk hypertensive patients, patients with multiple diseases, and those isolated due to pandemics or national emergencies.
Hypertension is a key risk factor for cardiovascular disease. Currently, around a third of people with hypertension are undiagnosed, and of those diagnosed, around half are not taking ...antihypertensive medications. The World Health Organisation (WHO) estimates that high blood pressure directly or indirectly causes deaths of at least nine million people globally every year.
Purpose of Review
In this review, we examine how emerging technologies might support improved detection and management of hypertension not only in the wider population but also within special population groups such as the elderly, pregnant women, and those with atrial fibrillation.
Recent Findings
There is an emerging trend to empower patients to support hypertension screening and diagnosis, and several studies have shown the benefit of tele-monitoring, particularly when coupled with co-intervention, in improving the management of hypertension.
Summary
Novel technology including smartphones and Bluetooth®-enabled tele-monitoring are evolving as key players in hypertension management and offer particular promise within pregnancy and developing countries. The most pressing need is for these new technologies to be properly assessed and clinically validated prior to widespread implementation in the general population.
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