Comparison of short and long forms of the Flinders program of chronic disease SELF-management for participants starting SGLT-2 inhibitors for congestive heart failure (SELFMAN-HF): protocol for a prospective, observational study

IntroductionCongestive heart failure (CHF) causes significant morbidity and mortality. It is an epidemic, and costs are escalating. CHF is a chronic disease whose trajectory includes stable phases, periods of decompensation, and finally palliation. Health services and medical therapies must match the various patient needs. Chronic disease self-management (CDSM) programmes that are patient-focused, identify problems and set actionable goals that appear as a logical, cost-friendly method to navigate patient journeys. There have been challenges in standardising and implementing CHF programmes.Methods and analysisSELFMAN-HF is a prospective, observational study to evaluate the feasibility and validity of the SCRinHF tool, a one-page self-management and readmission risk prediction tool for CHF, with an established, comprehensive CDSM tool. Eligible patients will have CHF with left ventricular ejection fraction <40% and commenced sodium glucose co-transporter-2 inhibitors (SGLT2-i) within 6 months of recruitment. The primary endpoint is the 80% concordance in readmission risk predicted by the SCRinHF tool. The study will recruit >40 patients and is expected to last 18 months.Ethics and disseminationThis study has been approved by the St Vincent’s ethics committee (approval no. LRR 177/21). All participants will complete a written informed consent prior to enrolment in the study. The study results will be disseminated widely via local and international health conferences and peer-reviewed publications

Challenges of Health Data Use in Multidisciplinary Chronic Disease Care: Perspective from Heart Failure Care

The healthcare sector generates approximately 30% of all the world’s data volume, mostly for record keeping, compliance and regulatory requirements, and patient care. Healthcare data often exist in silos or on different systems and platforms due to decentralised storage and data protection laws, limiting accessibility for health service research. Thus, both the lack of access to data and more importantly the inability to control data quality and explore post-trial (phase IV) data or data with translational relevance have an impact on optimising care and research of congestive heart failure (CHF). We highlight that for some diseases, such as CHF, generating non-traditional data has significant importance, but is hindered by the logistics of accessing chronic disease data from separate health silos and by various levels of data quality. Modern multidisciplinary healthcare management of cardiovascular diseases—especially when spanning across community hubs to tertiary healthcare centres—increases the complexities involved between data privacy and access to data for healthcare and health service research. We call for an increased ability to leverage health data across systems, devices, and countries

Contextualising evidence based medicine in determining the key root for translational effectiveness for chronic disease self-management and heart failure

Background: Congestive heart failure (CHF) management has proven devastating on morbidity, mortality, quality of life and also costly to health systems. Therapeutics for CHF have advanced and benefited greatly due to large multicentre randomised controlled trials and the evidence obtained from them. Management for chronic diseases and nonpharmaceutical therapies such as chronic disease self-management has lagged, and for CHF the evidence base has even been questioned. Methods: Perspective and non systematic mini review. Conclusions: Advancing translational research standards is important to achieve optimal cost effectiveness. Importantly is understanding evidence generation in medicine, identifying the primary roots for management and its translation

A Review of the External Validity of Clinical Trials with Beta-Blockers in Heart Failure

This is an open-access article distributed under the terms of the Creative Commons CC-BY-NC 3.0 License.Background: Beta-blockers (BBs) are the mainstay prognostic medication for all stages of chronic heart failure (CHF). There are many classes of BBs, each of which has varying levels of evidence to support its efficacy in CHF. However, most CHF patients have one or more comorbid conditions such as diabetes, renal impairment, and/or atrial fibrillation. Patient enrollment to randomized controlled trials (RCTs) often excludes those with certain comorbidities, particularly if the symptoms are severe. Consequently, the extent to which evidence drawn from RCTs is generalizable to CHF patients has not been well described. Clinical guidelines also underrepresent this point by providing generic advice for all patients. The aim of this review is to examine the evidence to support the use of BBs in CHF patients with common comorbid conditions. Methods: We searched MEDLINE, PubMed, and the reference lists of reviews for RCTs, post hoc analyses, systematic reviews, and meta-analyses that report on use of BBs in CHF along with patient demographics and comorbidities. Results: In total, 38 studies from 28 RCTs were identified, which provided data on six BBs against placebo or head to head with another BB agent in ischemic and nonischemic cardiomyopathies. Several studies explored BBs in older patients. Female patients and non-Caucasian race were underrepresented in trials. End points were cardiovascular hospitalization and mortality. Comorbid diabetes, renal impairment, or atrial fibrillation was detailed; however, no reference to disease spectrum or management goals as a focus could be seen in any of the studies. In this sense, enrollment may have limited more severe grades of these comorbidities. Conclusions: RCTs provide authoritative information for a spectrum of CHF presentations that support guidelines. RCTs may provide inadequate information for more heterogeneous CHF patient cohorts. Greater Phase IV research may be needed to fill this gap and inform guidelines for a more global patient population

Comparison of short and long forms of the Flinders program of chronic disease SELF-management for participants starting SGLT-2 inhibitors for congestive heart failure (SELFMAN-HF): protocol for a prospective, observational study

Introduction: Congestive heart failure (CHF) causes significant morbidity and mortality. It is an epidemic, and costs are escalating. CHF is a chronic disease whose trajectory includes stable phases, periods of decompensation, and finally palliation. Health services and medical therapies must match the various patient needs. Chronic disease self-management (CDSM) programmes that are patient-focused, identify problems and set actionable goals that appear as a logical, cost-friendly method to navigate patient journeys. There have been challenges in standardising and implementing CHF programmes. Methods and analysis: SELFMAN-HF is a prospective, observational study to evaluate the feasibility and validity of the SCRinHF tool, a one-page self-management and readmission risk prediction tool for CHF, with an established, comprehensive CDSM tool. Eligible patients will have CHF with left ventricular ejection fraction 40 patients and is expected to last 18 months. Ethics and dissemination: This study has been approved by the St Vincent’s ethics committee (approval no. LRR 177/21). All participants will complete a written informed consent prior to enrolment in the study. The study results will be disseminated widely via local and international health conferences and peer-reviewed publications

Northern Territory Heart Failure Initiative–Clinical Audit (NTHFI–CA)–a prospective database on the quality of care and outcomes for acute decompensated heart failure admission in the Northern Territory: study design and rationale

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/Introduction Congestive heart failure is a significant cause of morbidity and mortality in Australia. Accurate data for the Northern Territory and Indigenous Australians are not presently available. The economic burden of this chronic cardiovascular disease is felt by all funding bodies and it still remains unclear what impact current measures have on preventing the ongoing disease burden and how much of this filters down to more remote areas. Clear differentials also exist in rural areas including a larger Indigenous community, greater disease burden, differing aetiologies for heart failure as well as service and infrastructure discrepancies. It is becoming increasingly clear that urban solutions will not affect regional outcomes. To understand regional issues relevant to heart failure management, an understanding of the key performance indicators in that setting is critical. Methods and analysis The Northern Territory Heart Failure Initiative—Clinical Audit (NTHFI-CA) is a prospective registry of acute heart failure admissions over a 12-month period across the two main Northern Territory tertiary hospitals. The study collects information across six domains and five dimensions of healthcare. The study aims to set in place an evidenced and reproducible audit system for heart failure and inform the developing heart failure disease management programme. The findings, is believed, will assist the development of solutions to narrow the outcomes divide between remote and urban Australia and between Indigenous and Non-Indigenous Australians, in case they exist. A combination of descriptive statistics and mixed effects modelling will be used to analyse the data. Ethics and dissemination This study has been approved by respective ethics committees of both the admitting institutions. All participants will be provided a written informed consent which will be completed prior to enrolment in the study. The study results will be disseminated through local and international health conferences and peer reviewed manuscripts

Burden from Study Questionnaire on Patient Fatigue in Qualitative Congestive Heart Failure Research

Mixed methods research forms the backbone of translational research methodologies. Qualitative research and subjective data lead to hypothesis generation and ideas that are then proven via quantitative methodologies and gathering objective data. In this vein, clinical trials that generate subjective data may have limitations, when they are not followed through with quantitative data, in terms of their ability to be considered gold standard evidence and inform guidelines and clinical management. However, since many research methods utilise qualitative tools, an initial factor is that such tools can create a burden on patients and researchers. In addition, the quantity of data and its storage contributes to noise and quality issues for its primary and post hoc use. This paper discusses the issue of the burden of subjective data collected and fatigue in the context of congestive heart failure (CHF) research. The CHF population has a high baseline morbidity, so no doubt the focus should be on the content; however, the lengths of the instruments are a product of their vigorous validation processes. Nonetheless, as an important source of hypothesis generation, if a choice of follow-up qualitative assessment is required for a clinical trial, shorter versions of the questionnaire should be used, without compromising the data collection requirements; otherwise, we need to invest in this area and find suitable solution

Comorbid Heart Failure and Renal Impairment: Epidemiology and Management.

Heart failure mortality is significantly increased in patients with baseline renal impairment and those with underlying heart failure who subsequently develop renal dysfunction. This accelerated progression occurs independent of the cause or grade of renal dysfunction and baseline risk factors. Recent large prospective databases have highlighted the depth of the current problem, while longitudinal population studies support an increasing disease burden. We have extensively reviewed the epidemiological and therapeutic data among these patients. The evidence points to a progression of heart failure early in renal impairment, even in the albuminuric stage. The data also support poor prescription of prognostic therapies. As renal function is the most important prognostic factor in heart failure, it is important to establish the current understanding of the disease burden and the therapeutic implications