Home telemonitoring in heart failure patients and the effect of study design on outcome: A literature review

2021 ◽  
pp. 1357633X2110371
Author(s):  
Chukwuemeka A. Umeh ◽  
Maunika Reddy ◽  
Ankit Dubey ◽  
Mohammad Yousuf ◽  
Sumanta Chaudhuri ◽  
...  
Keyword(s):  
Heart Failure ◽  
High Risk ◽  
North America ◽  
Hospital Admission ◽  
Study Design ◽  
Randomized Controlled ◽  
Home Telemonitoring ◽  
Pubmed Database ◽  
Wide Range ◽  
Study Designs

Introduction A wide range of study designs have been utilized in evaluations of home telemonitoring and these studies have produced conflicting outcomes over the years. While some of the research has shown that telemonitoring is beneficial in reducing all-cause mortality, hospital admission, length of stay in hospital and emergency room visits, other studies have not shown such benefits. This study, therefore, aims to examine several home telemonitoring study designs and the influence of study design on study outcomes. Method Articles were obtained by searching PubMed database with the term heart failure combined with the following terms: telemonitoring, telehealth, home monitoring, and remote monitoring. Searches were limited to randomized controlled trial conducted between year January 1, 2000 and February 6, 2021. The characteristics of the study designs and study outcomes were extracted and analyzed. Result Our review of 34 randomized controlled trials of heart failure telemonitoring did not show any significant influence of study design on reduction in number of hospitalizations and/or decrease in mortality. Studies that were done outside North America (USA and Canada) and studies that selected patients at high risk of re-hospitalization were more likely to result in decreased hospitalization and/or mortality, though this was not statistically significant. All the studies that met our inclusion criteria were from high-income countries and only one study enrolled patients at high risk of re-hospitalization. Conclusion There is a need for more studies to understand why telemonitoring studies in Europe were more likely to reduce hospital admission and mortality compared to those in North America. There is also a need for more studies on the effect of telemonitoring in patients at high risk of hospital readmission.

scholarly journals Conceptualising natural and quasi experiments in public health

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Frank de Vocht ◽  
Srinivasa Vittal Katikireddi ◽  
Cheryl McQuire ◽  
Kate Tilling ◽  
Matthew Hickman ◽  
...  
Keyword(s):  
Public Health ◽  
Study Design ◽  
Grey Literature ◽  
Public Health Research ◽  
Natural Experiments ◽  
Target Trial ◽  
Design Elements ◽  
Randomized Controlled ◽  
Study Designs ◽  
The Impact

Abstract Background Natural or quasi experiments are appealing for public health research because they enable the evaluation of events or interventions that are difficult or impossible to manipulate experimentally, such as many policy and health system reforms. However, there remains ambiguity in the literature about their definition and how they differ from randomized controlled experiments and from other observational designs. We conceptualise natural experiments in the context of public health evaluations and align the study design to the Target Trial Framework. Methods A literature search was conducted, and key methodological papers were used to develop this work. Peer-reviewed papers were supplemented by grey literature. Results Natural experiment studies (NES) combine features of experiments and non-experiments. They differ from planned experiments, such as randomized controlled trials, in that exposure allocation is not controlled by researchers. They differ from other observational designs in that they evaluate the impact of events or process that leads to differences in exposure. As a result they are, in theory, less susceptible to bias than other observational study designs. Importantly, causal inference relies heavily on the assumption that exposure allocation can be considered ‘as-if randomized’. The target trial framework provides a systematic basis for evaluating this assumption and the other design elements that underpin the causal claims that can be made from NES. Conclusions NES should be considered a type of study design rather than a set of tools for analyses of non-randomized interventions. Alignment of NES to the Target Trial framework will clarify the strength of evidence underpinning claims about the effectiveness of public health interventions.

scholarly journals Efficacy and Safety of Shengmai Injection for Chronic Heart Failure: A Systematic Review of Randomized Controlled Trials

2020 ◽  
Vol 2020 ◽  
pp. 1-10
Author(s):  
Yanping Wang ◽  
Xu Zhou ◽  
Xiaofan Chen ◽  
Fei Wang ◽  
Weifeng Zhu ◽  
...  
Keyword(s):  
Heart Failure ◽  
High Risk ◽  
Chronic Heart Failure ◽  
Western Medicine ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Shengmai Injection ◽  
Randomized Controlled

Background. Shengmai injection (SMI) is made from purified ginseng, Radix Ophiopogonis, and Schisandra chinensis. It has cardiotonic effects and is clinically used for the adjuvant treatment of chronic heart failure (CHF). However, its efficacy and safety are uncertain. The purpose of this study was to systematically evaluate the existing efficacy and safety evidence in randomized controlled trials (RCTs) that studied SMI for the treatment of CHF. Methods. PubMed, Embase, Cochrane Library, clinicaltrials.gov, CNKI, Wanfang, VIP, and CBM databases were searched up to September 10, 2019. RCTs that compared basic Western medicine treatment with SMI + basic Western medicine were included. The Cochrane Collaboration Risk of Bias Tool was used to assess the risk of bias in the RCTs. The meta-analysis used the random effects model; the mean difference (MD) and 95% confidence intervals (CIs) were combined using the inverse variance method, and the Mantel–Haenszel method was used to combine the relative risk (RR) and 95% CIs. Heterogeneity was assessed using I2 and Q tests, and the source of heterogeneity was explored by analyzing three preset subgroup hypotheses. Results. A total of 20 RCTs were included (n = 1562), with a moderate-to-high risk of bias. The meta-analysis showed that, compared with Western medicine alone, SMI adjuvant therapy significantly improved cardiac function indicators, including left ventricular ejection fraction (MD 6.8%, 95% CI 4.68 to 8.91), stroke volume (MD 9.81 ml, 95% CI 5.67 to 13.96), cardiac output (MD 0.96 L/min, 95% CI 0.66 to 1.25), and cardiac index (MD 0.53 L/min, 95% CI 0.36 to 0.70); heterogeneity was generally high among these outcomes. Compared with the controls, patients receiving SMI adjuvant therapy also had a higher response to treatment (RR 2.89, 95% CI 2.10 to 3.99; I2 = 0%), a greater decrease in brain natriuretic peptide levels (MD −284.66 ng/l, 95% CI −353.73 to −215.59, I2 = 0%), and a greater increase in six‐minute walk test performance (MD 70.67 m, 95% CI 22.92 to 118.42; I2 = 84%). Nine studies reported mild adverse events, such as gastrointestinal reactions, and no serious adverse events were reported. Conclusion. Currently, available evidence indicates that SMI, as an adjuvant for basic Western medicine treatment, can improve the cardiac function of patients with CHF with good safety outcomes. Because of the high risk of bias among the included RCTs and the large heterogeneity of partial outcomes, the findings of this study must be verified by high-quality studies with large sample sizes.

scholarly journals 5.7 The Input of Home Telemonitoring for the Treatment of Chronic Heart Failure in Old People at High Risk

2008 ◽  
Vol 15 (3) ◽  
pp. 216-216
Author(s):  
M. Benvenuto ◽  
L. Beltrami ◽  
C. Redaelli ◽  
D. Solari ◽  
M. Pozzi ◽  
...  
Keyword(s):  
Heart Failure ◽  
High Risk ◽  
Chronic Heart Failure ◽  
Old People ◽  
Home Telemonitoring

P323Triage-HF Plus: identification of heart failure and non-heart failure events in an ambulatory population using remote monitoring and the triage heart failure risk score Algorithm

EP Europace ◽  
2020 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
F Ahmed ◽  
J Taylor ◽  
C Green ◽  
L Wickwar ◽  
A Zaidi ◽  
...  
Keyword(s):  
Heart Failure ◽  
High Risk ◽  
Risk Score ◽  
Remote Monitoring ◽  
Predictive Value ◽  
Control Group ◽  
Telephone Triage ◽  
Integrated Monitoring ◽  
Failure Risk ◽  
Wide Range

Abstract Background/introduction Previous studies examining the utility of cardiac implantable electronic devices (CIEDs) to remotely monitor heart failure patients for decompensation have not demonstrated an impact on hard end-points. However, a key limitation of these prior studies (REM-HF and MORE-CARE) has been the failure to stratify patients according to their risk of worsening heart failure (WHF) prior to randomization (usual care vs active monitoring). We examined a different approach, using a single manufacturer’s remote monitoring platform, whereby only patients with CIED-derived data indicating the highest risk of WHF are contacted for assessment. The validated ‘Triage Heart Failure Risk Score’ (Triage-HFRS) is a medical algorithm within Medtronic CIEDs that can risk-stratify patients as low-, medium- or high-risk of WHF in the next 30 days based on integrated monitoring of physiological parameters. Purpose  This study is the largest prospective evaluation of the Triage-HFRS, and examines the additional role of contacting those patients with a ‘High-Risk’ Triage-HFRS alert by telephone (Triage-HF Plus pathway). Methods  Prospective, real-world evaluation of the Triage-HF Plus pathway undertaken between June 2016 and September 2019. 326 high-risk Triage-HFRS transmissions were contacted for telephone triage assessment. Screening questions were designed to identify episodes of WHF and non-heart failure events. Interventions were at the discretion of the clinical practitioner and in line with guideline-directed practice. An additional 3-month consecutive sample of low and medium Triage-HFRS transmissions (control group) were also contacted for telephone triage assessment (n= 98). Results Successful telephone contact was made following 245 high-risk Triage-HFRS alerts. Following contact, 194 (79.1%) patients reported an acute medical issue: 137 (70.6%) reported symptoms consistent with worsening heart failure (WHF) requiring intervention; and 57 (29.4%) had an alternative acute medical problem. 51 (26.2%) had no apparent reason for the high score. The sensitivity and specificity of CIED-based remote monitoring to identify any HF and non-HF events requiring intervention was 99.5% (97.2-99.9%) and 65.5% (57.3-73.2%) respectively; positive predictive value was 79.2%. The negative predictive value of a non-high risk score to rule out an acute event was 98.9%. Overall accuracy of the pathway to identify an acute issue (HF or non-HF related) was 84.8%. Conclusion The Triage-HF Plus clinical pathway is a potentially useful remote monitoring tool for patients with heart failure. The pathway has high diagnostic accuracy to identify patients with WHF and a wide range of non-HF issues which are just as relevant in a population who often have multiple complex co-morbidities and are known for their high health care utilisation.

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