Navigating the Landscape of Medical Device Advisories: A Special Report from the Canadian Heart Rhythm Society Device Advisory Committee.

Cardiac implantable electronic devices (CIED) are often important for regulating cardiac rate and rhythm. Pacemakers and defibrillators are among the top 10 most-implanted medical devices, with >1.5 million devices implanted annually. While millions of patients have benefited with improved quality of life and survival, CIED-systems are increasingly complex and do not always perform according to expectations. Advisory notices communicate important information about the safety and performance of a medical device to healthcare providers and patients. Medical device recalls are common, with >35 unique device recalls in the past five years. From an ethical standpoint, CIED recalls highlight a range of considerations including the consent process, duty to report, how best to promote autonomous decision-making, trust in the healthcare system, as well as disproportionate impact of these considerations on equity-deserving groups. The purpose of the current article is to review and advise regarding the process around medical device advisory and recall, with a specific focus on clinicians caring for patients affected by these devices. We have sought the input of a lawyer, a patient advocacy group, and an ethicist to guide the clinical management of, and communications regarding, device recalls and advisories. Diligent surveillance and a clear, transparent patient consent process regarding these small but potentially serious device-anomalies is paramount in ensuring patients feel safe and informed. Meaningful patient engagement helps to ensure optimal communication and disclosure mechanisms before implant and throughout follow-up, accessibility of information both in the initial implant and recall action process, and trust in healthcare systems and providers.

Qualitative Analysis of Patient Decisional Needs for Medications to Treat Heart Failure.

BACKGROUND: The development of tools to support shared decision-making should be informed by patients' decisional needs and treatment preferences, which are largely unknown for heart failure (HF) with reduced ejection fraction (HFrEF) pharmacotherapy decisions. We aimed to identify patients' decisional needs when considering HFrEF medication options. METHODS: This was a qualitative study using semi-structured interviews. We recruited patients with HFrEF from 2 Canadian ambulatory HF clinics and clinicians from Canadian HF guideline panels, HF clinics, and Canadian HF Society membership. We identified themes through inductive thematic analysis. RESULTS: Participants included 15 patients and 12 clinicians. Six themes and associated subthemes emerged related to HFrEF pharmacotherapy decision-making: (1) patient decisional needs included lack of awareness of a choice or options, difficult decision timing and stage, information overload, and inadequate motivation, support and resources; (2) patients' decisional conflict varied substantially, driven by unclear trade-offs; (3) treatment attribute preferences-patients focused on both benefits and downsides of treatment, whereas clinicians centered discussion on benefits; (4) quality of life-patients' definition of quality of life depended on pre-HF activity, though most patients demonstrated adaptability in adjusting their daily activities to manage HF; (5) shared decision-making process-clinicians' described a process more akin to informed consent; (6) decision support-multimedia decision aids, virtual appointments, and primary-care comanagement emerged as potential enablers of shared decision-making. CONCLUSIONS: Patients with HFrEF have several decisional needs, which are consistent with those that may respond to decision aids. These findings can inform the development of HFrEF pharmacotherapy decision aids to address these decisional needs and facilitate shared decision-making.

Identification of urgent gaps in public and policymaker knowledge of heart failure: Results of a global survey.

BACKGROUND: Despite advances in the treatment of heart failure (HF) with reduced ejection fraction, people with HF continue to have a high risk of mortality and hospitalisation. Patients also suffer from poor quality of life, with reduced societal and economic participation. The burden of HF on patients and healthcare systems is extraordinary, yet awareness remains low. This survey was conducted to identify gaps in general public and policymaker knowledge around HF. METHODS: A closed-question web-based survey of the general public and policymakers was conducted between February and October 2020. Study outcomes assessed the participants' awareness and understanding of HF symptoms, risk factors and mortality, and views around hospital admissions in their country. Responses were collected using multiple-choice questions. RESULTS: The survey was completed by 26,272 general public respondents in 13 countries and 281 government and public sector policymakers in nine countries. While 99% of general public respondents had heard of HF, their understanding of the condition and its symptoms was poor, and only 6% identified that shortness of breath, fatigue, and leg swelling were the main symptoms of HF. Of policymaker respondents, 14% identified HF as the leading cause of avoidable hospitalisations, and only 4% recognised that ~ 87% of government spending on HF is related to hospitalisations. CONCLUSIONS: Major gaps were identified in the understanding of HF and the burden it places on patients and their caregivers, healthcare systems and society. This study confirms an ongoing need for national policy strategies and investment to raise awareness of the importance of HF prevention, early diagnosis, and implementation of effective treatments to reduce hospitalisations and death.

Challenges and opportunities for increasing patient involvement in heart failure self-care programs and self-care in the post-hospital discharge period.

BACKGROUND: People living with heart failure (HF) are particularly vulnerable after hospital discharge. An alliance between patient authors, clinicians, industry, and co-developers of HF programs can represent an effective way to address the unique concerns and obstacles people living with HF face during this period. The aim of this narrative review article is to discuss challenges and opportunities of this approach, with the goal of improving participation and clinical outcomes of people living with HF. METHODS: This article was co-authored by people living with HF, heart transplant recipients, patient advocacy representatives, cardiologists with expertise in HF care, and industry representatives specializing in patient engagement and cardiovascular medicine, and reviews opportunities and challenges for people living with HF in the post-hospital discharge period to be more integrally involved in their care. A literature search was conducted, and the authors collaborated through two virtual roundtables and via email to develop the content for this review article. RESULTS: Numerous transitional-care programs exist to ease the transition from the hospital to the home and to provide needed education and support for people living with HF, to avoid rehospitalizations and other adverse outcomes. However, many programs have limitations and do not integrally involve patients in the design and co-development of the intervention. There are thus opportunities for improvement. This can enable patients to better care for themselves with less of the worry and fear that typically accompany the transition from the hospital. We discuss the importance of including people living with HF in the development of such programs and offer suggestions for strategies that can help achieve these goals. An underlying theme of the literature reviewed is that education and engagement of people living with HF after hospitalization are critical. However, while clinical trial evidence on existing approaches to transitions in HF care indicates numerous benefits, such approaches also have limitations. CONCLUSION: Numerous challenges continue to affect people living with HF in the post-hospital discharge period. Strategies that involve patients are needed, and should be encouraged, to optimally address these challenges.

Heart failure (HF) is a common, serious condition that causes debilitating symptoms. HF results in an enormous burden on individuals and society. For many people living with HF, the transition to the home after hospital discharge is filled with uncertainty, fear, miscommunication, feelings of vulnerability, loss of control, high rates of being hospitalized again, and the need for education about HF self-care. People living with HF need reliable support, personalized education, and encouragement to minimize disruption to their lives and to enable them to participate in and take ownership of their health. Interventions after hospitalization focused on self-care and education have been shown to improve confidence, medication adherence rates, quality of life, and self-care, and to reduce the risk of death or being hospitalized again. However, not all studies have found benefits. Many interventions do not include patients in their co-design and co-development, and/or co-authorship of the study publications. In this review article, we discuss challenges and opportunities for better involving people living with HF in self-care HF programs, both as co-creators and as participants. A literature search was conducted and the authors collaborated through email and two remote discussions to develop the article's content. We discuss the burden of HF and existing approaches to care after hospitalization. We also provide an overview of some of the challenges and opportunities in involving people living with HF more closely in their care. We conclude that patient-focused solutions aligned with behavioral approaches and education related to self-care may help overcome these challenges.

Automated digital counselling with social network support as a novel intervention for patients with heart failure: protocol for randomised controlled trial.

INTRODUCTION: Heart failure (HF) symptoms improve through self-care, for which adherence remains low among patients despite the provision of education for these behaviours by clinical teams. Open Access Digital Community Promoting Self-Care, Peer Support and Health Literacy (ODYSSEE-vCHAT) combines automated digital counselling with social network support to improve mortality and morbidity, engagement with self-care materials, and health-related quality of life. METHODS AND ANALYSIS: Use of ODYSSEE-vCHAT via Internet-connected personal computer by 162 HF patients will be compared with a control condition over 22 months. The primary outcome is a composite index score of all-cause mortality, all-cause emergency department visits, and HF-related hospitalisation at trial completion. Secondary outcomes include individual components of the composite index, engagement with self-care materials, and patient-reported measures of physical and psychosocial well-being, disease management, health literacy, and substance use. Patients are recruited from tertiary care hospitals in Toronto, Canada and randomised on a 1:1 ratio to both arms of the trial. Online assessments occur at baseline (t=0), months 4, 8 and 12, and trial completion. Ordinal logistic regression analyses and generalised linear models will evaluate primary and secondary outcomes. ETHICS AND DISSEMINATION: The trial has been approved by the research ethics boards at the University Health Network (20-5960), Sunnybrook Hospital (5117), and Mount Sinai Hospital (21-022-E). Informed consent of eligible patients occurs in person or online. Findings will be shared with key stakeholders and the public. Results will allow for the preparation of a Canada-wide phase III trial to evaluate the efficacy of ODYSSEE-vCHAT in improving clinical outcomes and raising the standard of outpatient care. TRIAL REGISTRATION NUMBER: NCT04966104.

Patient and Public Engagement in Integrated Knowledge Translation Research: Are we there yet?

PLAIN ENGLISH SUMMARY: There have been many attempts to improve how healthcare services are developed and delivered. Despite this, we know that there are many gaps and differences in practice and that these can lead to poor patient outcomes. In addition, there are also concerns that research is being undertaken that does not reflects the realities or needs of those using healthcare services, and that the use of research findings in practice is slow. As such, shared approaches to research, such as integrated knowledge translation, are being used.Integrated knowledge translation (IKT) is a research approach that brings together researchers, along with other stakeholders that have knowledge about a particular healthcare issue. Stakeholders may include healthcare providers and policy-makers. More recently, there has been a growing awareness of the need to include patients and members of the public within research processes. These collaborative and patient-oriented research approaches are seen as a way to develop research that tackles ongoing gaps in practice and reflect the insights, needs and priorities of those most affected by health research outcomes. Despite great support, little is known about how these major research approaches are connected, or how they may bring about improvements in the development and use of research evidence. In this paper, we examine how IKT and patient engagement processes are linked, as well as exploring where differences exist. Through this, we highlight opportunities for greater patient engagement in IKT research and to identify areas that need to be understood further. ABSTRACT: Healthcare organizations across the world are being increasingly challenged to develop and implement services that are evidence-based and bring about improvement in patient and health service outcomes. Despite an increasing emphasis upon evidence-based practice, large variations in practice remain and gaps pervade in the creation and application of knowledge that improves outcomes. More collaborative models of health research have emerged over recent years, including integrated knowledge translation (IKT), whereby partnerships with key knowledge users are developed to enhance the responsiveness and application of the findings. Likewise, the meaningful engagement of patients, in addition to the inclusion of patient-reported outcomes and priorities, has been hailed as another mechanism to improve the relevance, impact and efficiency of research.Collectively, both IKT and patient engagement processes provide a vehicle to support research that can address health disparities and improve the delivery of effective and responsive healthcare services. However, the evidence to support their impact is limited and while these approaches are inextricably connected through their engagement focus, it is unclear how IKT and patient engagement processes are linked conceptually, theoretically, and practically. In this paper, we will begin to critically examine some of the linkages and tensions that exist between IKT and patient-engagement for research and will examine potential opportunities for IKT researchers as they navigate and enact meaningful partnerships with patients and the public.