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

Abstract

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.

Keywords: Chronic disease; clinical translation; health policy; heart failure; patient-reported outcomes; screening.

Fig. (1)

Research Structure and Implementation Pathways. A. Research studies answer local questions, broad global questions or the cost and outcome equation, through graded control of variables, limiting subconscious and other biases, and statistical support to calculate power and validity. Efficacy – how it works; Effectiveness – does it work?; Cost-effectiveness – is it worth it?. B. Governance – processes are not equally regulated at all levels to ensure all levels of health services can freely interpret evidence for individual patient needs. Translation of decision require 3 tiers, evidence, client, health services and political will. Generalizability, inclusivity of stakeholders can influence events post evidence generation [11].

Fig. (2)

CCRE quality improvement and outcomes research bridge and support. The role for Clinical Centre For Excellence (CCRE) is outlined. Clinical care is shaped around standardised Disease Management e.g Krumholtz 8 domain program. Clinical Observation are at the heart of interactions. Important findings require the necessary support or bridging to achieve cost-effectiveness. Depending on the level of expertise and experience CCRE could help health clusters navigate question of research design, system gaps, and improvement methodology based on Industry or Health care concepts. It is vital that infrastructure within a cluster be used first and CCRE engaged when health clusters require assistance. Concepts modified from ref [3,10, 16]. Disease Management: 1. Patient Population - Risk Status, Comorbid Condition, Non-clinical features; 2. Recipient - Patient/ Caregiver; Case Provider; 3. Intervention Content - Patient/ Caregiver Education, Medical Management, Peer Support, Remote Monitoring; 4. Delivery Personnel – Nurse, Physician, Pharmacist, social workers, Dieticians, Physical therapists, Psychologists, Case managers, Care coordinators; 5. Method of Communication – Face-to-face individual, Face-to-face group, Telephone in person, Telephone Mechanised, Internet; 6. Intensity and Complexity – Duration, Frequency/ Periodicity, Complexity; 7. Environment – Hospital in-patient, Hospital out-patient, Home-based; 8. Outcome Measures – Clinical measures, Process Measures, Quality of life measures, Patient Satisfaction, Provider Satisfaction. Translational Research Disciplines: 1. T1 Bench to Human - Basic Science, Molecular Biology, Genetics, Technology Assessment, Animal Research, Phase I & II clinical trials; 2. T2 Human to Guideline Phase 3 clinical trials, observational studies, evidence synthesis and guidelines, clinical epidemiology, comparative effectiveness, policy and ethics; 3. T3 Guideline to Patient - Implementation and Dissemination, systems redesign, communication theory, behavioural and management science, organizational development, patient encounter research.

Fig. (3)

Screening and prevention clinical-research paradigm. Figure highlights the progression of medical practice. Clinical observation of diseases and discussed to gain directions for solutions. Research identifies early proofs and via clinical trials prove these early findings. Clinical management takes shape by having evidence for trial populations. Gaps will exist and this is examined as post trial or phase IV observations. The eventual goal of post-trial studies are linked between how to achieve cost-effectiveness or the most acceptable balance between service cost and achievable outcomes. Three essential determinants of cost effectiveness of any disease are public health issues. These have a chronological factor in common which is to be done early e.g. screening for diseases, preventing progression and communication between client and health systems.

Fig. (4)

Screening and self-management and patient reported outcomes link.

Fig. (5)

Pathways For health policy institutes to steer translational research. (a). Pathway for translation and cost-efficacy. The common final endpoint of all research is cost effectiveness. This is also the least actioned and most important arm of translational research. All health jurisdictions should have a mechanism to answer questions to ensure safe and robust health translation and act on variations. IMPLEMENT-IT is a concept for a Policy Institute to take up the role to create governance structures and provide consultancy to other Australian institutes to implement all levels of research that has relevance to individual patients. It is envisaged the Institute will assist in six subdomains: 1) Research design; 2) Research application (translation) i. routine ii. challenges; 3) Transforming research to translational level; 4) Funding and infrastructure; 5) Bridging and collaboration; 6) Governance and cost-efficacy.

(b). Governance framework for translational research. External validity of clinical trials are increasingly relevant for Australian populations. Observation may note marked regional variations. Guidelines do not always incorporate recommendations for the heterogeneity and demographic differences that may lead to the observed variations in outcomes. The process of accumulating powered, valid, generalisable evidence is rigorous and can be difficult. Smaller non-trial-based studies can be limited by power and hence translatability to the bedside to make it into guidelines. However, all evidence could have local or selective applications. In this regard investing in IMPLEMENT-IT, Policy Institute infrastructure to govern, consult and participate in the field could be advantageous to Australian Cardiovascular community. Directory is a hub role to link to relevant health or research organisations.