Effectiveness of self-management programmes for heart failure with reduced ejection fraction: a systematic review protocol.

INTRODUCTION: Chronic disease self-management (CDSM) is a vital component of congestive heart failure (CHF) programmes. Recent CHF guidelines have downgraded CDSM programmes citing a lack of gold-standard evidence. This protocol describes the aims and methods of a systematic review to collate and synthesise the published research evidence to determine the effectiveness of CDSM programmes and interventions for patients treated for CHF. METHODS: Medline, PubMed, Embase, CENTRAL, CINAHL, Cochrane Central Register of Controlled Trials, PsycINFO, SCOPUS, Web of Science, the Science Citation Index and registers of clinical trials will be searched from 1966 to 2024. In addition, the reference lists of shortlisted articles will be reviewed. Randomised controlled trials, with case management interventions of CDSM and CHF with reported major adverse cardiovascular events (MACEs), will be extracted and analysed. There is no restriction on language. Study protocol template developed from Cochrane Collaboration and Reporting adheres to Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol guidelines for systematic review and meta-analyses 2020. Two independent authors will apply inclusions and exclusion criteria to limit article search and assess bias and certainty of evidence rating. Data extraction and study description of included studies will include quality appraisal of studies and quantitative synthesis of data will then be undertaken to ascertain evidence for the study aims. Subgroup analyses will be conducted for different CDSM programmes. The primary outcome will be a significant change in MACE parameters between intervention and control arms. Meta-analysis will be conducted using statistical software, if feasible. ETHICS AND DISSEMINATION: Ethics approval is not sought as the study is not collecting primary patient data. The results of this study will be disseminated through peer-reviewed scientific journals and also presented to audiences through meetings and scientific conferences. PROSPERO REGISTRATION NUMBER: CRD42023431539.

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 solutions.

Barriers to Cardiac Rehabilitation among Patients Diagnosed with Cardiovascular Diseases-A Scoping Review.

BACKGROUND: Cardiovascular diseases (CVDs) are a rising global burden. Preventative strategies such as cardiac rehabilitation (CR) have shown a marked reduction in disease burden. Despite this, CR is underutilized worldwide. This study aims to identify the barriers to CR among patients diagnosed with CVD. METHODS: A scoping review of the literature was conducted following the Joanna Briggs Institute (JBI) guidelines. Four major databases, including CINAHL, PubMed, EBSCOhost, and Scopus, were used to obtain studies published between 2010 and 2023. Search terms such as "Cardiac rehab*", "Barrier*", "Cardiovascular", "Disease", and "diagnosis*" were utilized in order to obtain subject-specific studies relevant to the research question. RESULTS: From the initial 2098 studies, only 14 were included in the final analysis, consisting of both qualitative and quantitative designs. The thematic analysis included "healthcare system-related factors", "Socioeconomic factors", and "individual characteristics". Healthcare system-related factors were mostly related to the poor availability of CR programs, lack of proper referral strategies, inadequate knowledge of CR provider and inter-provider communication issues, and lack of alternative methods of CR delivery. The socioeconomic barriers were lack of education, longer distance to CR facilities, high cost of care, unemployment, and poor income status. The identified individual characteristics were female gender, older age, and comorbidities. CONCLUSIONS: Lack of resources, poor access, educational attainment, and high cost of care were some of the barriers to CR, particularly in low- and middle-income countries (LMICs). Health policymakers and healthcare providers should implement strategies incorporating the issues identified in this scoping review. Systematic reviews may be required to confirm these findings.

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.

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% 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 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.

The Wider Considerations in Closing Chronic Disease Gaps - Focus on Heart Failure and Implementation.

BACKGROUND: Heart failure (HF) is predominately a chronic disease. There are overlaps in HF and chronic disease research and care. Chronic disease and HF research are conducted with multiple goals. The overarching goal is "optimized patient outcomes at maximum costeffectiveness". However, observations on patients can come with many variables; thus, we see differences in clinical translation. This document discusses an argument for three important gaps common to HF and chronic disease, i.e., screening, self-management, and patient-reported outcomes (PRO), and provides a glance of how it could fit into the evidence tree. Pertinent arguments for a framework for health services and models of care are provided as a prelude to future consensus. METHODOLOGY: 1) A preliminary literature review to identify a taxonomy for cardiovascular research, and 2) a review of the published literature describing the translation of research studies into clinical practice for cardiovascular disorders. A spectrum from observational to large randomized controlled trials to post-marketing studies were identified. DISCUSSION: A brief discussion on traditional research and differences focusing on screening, mixed methods research concepts, and chronic diseases models of care. Six steps to facilitate this: 1) Research design; 2) Research application (translation) i. routine ii. challenges; 3. Transforming research to translational level; 4. Funding and infrastructure; 5. Clinical Centres of Research Excellence (CCRE) and collaboration; 6. Governance and cost-effectiveness. CONCLUSION: Implementation research that aims to link research findings to improved patient outcomes in an efficient and effective way is a neglected area. Skills required to perform implementation research are complex. Ways to maximize translational impacts for chronic disease research to clinical practice are described in a HF context.

Malthusian Trajectory for Heart Failure and Novel Translational Ambulatory Technologies.

INTRODUCTION: It has been estimated that congestive heart failure (CHF) will reach epidemic proportions and contribute to large unsustainable impacts on health budgets for any cardiovascular condition. Against other major trends in cardiovascular outcomes, readmission and disease burden continue to rise as the demographics shift. METHODS: The rise in heart failure with preserved ejection fraction (HFpEF) among elderly women will present new challenges. Gold standard care delivers sustainable and cost-effective health improvements using organised care programs. When coordinated with large hospitals, this can be replicated universally. RESULTS: A gradient of outcomes and ambulatory care needs to be shifted from established institutions and shared with clients and community health services, being a sizeable proportion of CHF care. CONCLUSION: In this review, we explore health technologies as an emerging opportunity to address gaps in CHF management.

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.

Defining Vulnerable Patients with Heart Failure: Opportunistic Lessons from Covid-19.

Congestive Heart Failure is a chronic disease that can be associated with poor outcomes. Some patients are more vulnerable, while others who are vulnerable appear absent or silent to health services. COVID-19 pandemic is a good opportunity to explore this important area. This review focuses on chronic disease, heart failure and those who require greater consideration.

Perspective on 'Phase V' or Logistics and Regression as Logical Progression for Community Heart Failure Triage.

Congestive Heart Filur is an epidemic and its trajectory apppears to be escaling. Undoubtly tremendous gains have seen improvement in life expectancy and quality of life, however, hospital readmissions, resource utilization and health system cost continue to create challenges. In this short perspective, we raise the prospect of extending the research phases the community and real world setting. Logistic have supported service supply chains during the COVID-19 pandemic and there are lesson here to be learned.

Rethinking heart failure care and health technologies from early COVID-19 experiences - A narrative review.

Heart Failure (HF), a common chronic disease, requires multidisciplinary care to optimise outcomes. The COVID-19 pandemic, its impact on people's movement and access to health services, introduced severe challenges to chronic disease management. The era that will evolve after this pandemic is likely to provide uncertainty and service model disruptions. HF treatment is based on guidelines derived from randomised clinical trial evidence. Translational shortfalls from trials into practice have been overcome with post-trial service improvement studies like OPTIMIZE-HF where a team using a process of care can translate evidence to the general population. However, gaps remain for vulnerable populations e.g. those with more severe HF, with multiple comorbid conditions, and certain demographic groups and/or residents in remote locations. Health technology has come with great promise, to fill some of these gaps. The COVID-19 pandemic provides an opportunity to observe, from Australian healthcare lens, HF management outside the traditional model of care. This narrative review describes relatively recent events with health technology as a solution to improve on service gaps.

Part 1: The Wider Considerations in Translating Heart Failure Guidelines.

Congestive Heart Failure (CHF) is an emerging epidemic. Within one generation, the medical community has learned much of CHF syndromes. It has two distinct mechanisms, systolic and diastolic abnormalities, to account for the common CHF presentation. It is complex as it challenges the available health care services, resource, and funding models in providing an equitable service across the health continuum. Despite the improvement in many cardiovascular diseases, some CHF outcomes like readmissions and costs have increased. The reinvigoration of evidence- based medicine, the development of health services models of care, and standardisation of disease processes with taxonomies have also occurred within the same time span. These processes, however, need to be linked with health policy as presented in white papers. In this paper, we explore achieving optimal CHF guideline-recommended outcomes as the science approaches realworld translation.

Common Comorbidities that Alter Heart Failure Prognosis - Shaping New Thinking for Practice.

At least half of all heart failure (CHF) patients will have a comorbidity that could be undertreated, requires additional speciality input and/or polypharmacy. These patients are then at risk of iatrogenic and disease-related complications and readmissions if not closely supervised. Common comorbidities of relevance are cardiorenal and cardiometabolic syndromes (DM, obesity, OSA), chronic airways disease, elderly age, and accompanying pharmacotherapies. The structure of community practice often leaves primary, speciality, and allied health care in silos. For example, cardiology speciality training in Australia creates excellent sub-specialists to deliver diagnostic and therapeutic advances. A casualty of this process has been the gradual alienation of general cardiology toward general internal medical specialists and primary care practitioners. The consequences are largely noticed in community practice. The issue is compounded by suboptimal communication of information. This review explores these issues from a cardiology sub-speciality lens; firstly cross speciality areas that are important for cardiologists to maintain their skill, and finally, to obtain a brief overview of disease management and identify game-changing common denominators such as endothelial dysfunction and self-management.

Forensic interrogation of diabetic endothelitis in cardiovascular diseases and clinical translation in heart failure.

Diabetic heart disease (DHD) can be classified as a primary consequence from several pathophysiological manifestation of diabetes mellitus (DM) on cardiac tissues or secondarily in extracardiac tissues and is encountered as either primary or secondary complications of DM. Endothelitis is inflammation of the vascular endothelium and is likely to be seen in the majority of patients who start to manifest an end organ complication of DM in this case DHD. Diabetes is a leading cause for many cardiovascular syndromes and diseases including congestive heart failure (CHF) however much remains unknown about the transition from diagnosed DM to clinical state and the contribution of the various mechanical and counterregulatory systems in the manifested complaint. Diastolic heart failure or heart failure with preserved ejection fraction (DHF/HFpEF), accounts for half of all CHF presentations, has DM as a major contributor, however, there remain large gaps in clinical and pathophysiological understanding. This review aims to explore the microscopic aspects in diabetic endothelitis and provide a clinical link to with context to HFpEF.

A Review of Randomized Controlled Trials Utilizing Telemedicine for Improving Heart Failure Readmission: Can a Realist Approach Bridge the Translational Divide?

BACKGROUND: Telemedicine and digital health technologies hold great promise for improving clinical care of heart failure. However, inconsistent and contradictory findings from randomized controlled trials have so far discouraged widespread adoption of digital health in routine clinical practice. We undertook this review study to summarize the study outcomes of the use of exploring the evidence for telemedicine in the clinical care of patients with heart failure and readmissions. METHODS: We inspected the references of guidelines and searched PubMed for randomized controlled trials published over the past 10 years on the use of telemedicine for reducing readmission in heart failure. We utilized a modified realist review approach to identify the underlying contextual mechanisms for the intervention(s) in each randomized controlled trial, evaluating outcomes of the intervention and understanding how and under what conditions they worked. To provide uniformity, all extracted data were synthesized using adapted domains from the taxonomy for disease management created by the Disease Management Taxonomy Writing Group. RESULTS: A total of 12 papers were eligible, 6 of them supporting and 6 others undermining the use of telemedicine for improving heart failure readmission. In general terms, those studies not supporting the use of telemedicine were multicentre, publicly funded, with large amount of participants, and long duration. The patients had also better rates of treatment with angiotensin-converting enzyme inhibitors/angiotensin II receptor blocker and beta-blockers, and telemonitoring and automatic transmission of vital signs were less utilized, in comparison with the studies in which telemedicine use was supported. The analysis of the environment, intensity, content of interventions, method of communication, quality of the underlying model of care and the ability, capability, and interest from health workers can help us to envisage probabilities of success of telemedicine use. CONCLUSIONS: A realist lens may aid to understand whom and in which circumstances the use of telemedicine can add any substantial value to traditional models of care. Wider outcome criteria beyond major adverse cardiovascular events, for example, cost efficacy, should also be considered as appropriate for effecting guidelines on care delivery when robust prognostic therapeutics already exist.

Non-invasive Risk Stratification for Coronary Artery Disease: Is It Time for Subclassifications?

PURPOSE OF REVIEW: Coronary artery disease (CAD) is the leading contributor to cardiovascular disease; it is the most prevalent non-communicable disease globally and has high morbidity, mortality and health care cost. Risk stratification is defined as prevention or containment of disease prior to it occurring or progressing, and non-invasive surrogates include history, examination, biomarkers and non-invasive imaging. This review aims to highlight advancement in current diagnostic strategies and explores gaps for CAD secondary to atherosclerosis and non-obstructive vascular diseases. RECENT FINDINGS: Cardiac risk scores have largely proven inadequate in risk stratifying heterogeneous patient populations. Greater emphasis should also be provided to posttest risk stratification. Non-invasive imaging with MRI is the most accurate but least cost efficacious presently due to availability and expertise. Echocardiography and nuclear imaging have good accuracy, but radiation limits the latter. Novel echocardiographic technologies may increase its appeal. Cardiac CT angiography is increasingly promising. Non-invasive and minimally invasive imaging has significantly influenced the cost-efficacy trajectory of coronary artery disease diagnosis and management. Recent studies suggest that future guidelines will incorporate more subclassifications from the findings of these novel technologies and for more diverse patient demographics.