CADTH Health Technology Review

Remote Monitoring Programs for Cardiac Conditions

PROSPERO Registration Number:

Realist Review: CRD42021229271

Perspectives and Experiences Review: CRD42020211271

Health Technology Assessment

Authors

Realist Review

Alexander Clark and Bailey Sousa led the Realist Review; screened and selected studies; extracted, tabulated, critically appraised, and interpreted data; wrote the Realist Review; revised the review based on reviewers’ feedback; and provided final approval to the version of the report submitted for publication.

Perspectives and Experiences Review

Andrea Smith led the protocol development for the Perspectives and Experiences Review; screened, selected, and critically appraised included studies; constructed the synthetic analysis and wrote the review; revised the review based on reviewers’ comments; and provided final approval to the version of the report submitted for publication. She also participated in patient engagement and stakeholder consultation activities.

Ethical Issues Analysis

Duncan Steele led the protocol development for the ethics analysis, including revisions according to reviewers’ feedback. Additionally, he screened and selected articles retrieved by the ethics search according to eligibility criteria, thematized relevant content according to core values, wrote the report; and revised the report based on reviewers’ comments. He provided final approval of the version submitted for publication.

Patient Engagement

Tamara Rader led patient engagement activities and wrote the summary of those activities included in the report. She also reviewed the protocol and drafts of the patients’ Perspectives and Experiences Review and provided final approval to the version of the report submitted for publication.

Research Information Services

Danielle MacDougall designed the database search strategies for all sections of the report, executed the search strategies, completed grey literature searches, maintained search alerts, prepared the search methods and appendix, and provided final approval to the version of the report submitted for publication.

David Kaunelis peer-reviewed the search strategies, assisted with report referencing, and approved the final version of the report submitted for publication.

Program Development

Jeff Mason developed the project plan, contributed to the coordination of the review, authored the introduction, and contributed to the writing of the Discussion as well as the Conclusions and Implications for Policy-Making sections of the report. He approved the final version of the report submitted for publication.

Jonathan Harris contributed to the writing of the Discussion as well as the Conclusions and Implications for Policy-Making sections of the report and provided final approval to the version of the report submitted for publication.

Contributors

The authors would like to acknowledge:

Saleema Allana, Karice Hyun, Annette Peart, and Rhianna (Anna) Penfold for their contributions in conducting the Realist Review.

Gino De Angelis for providing project oversight and coordination throughout the planning, conduct, and reporting of the clinical review, including providing methodological input and critically reviewing drafts of the protocol and final report

Deirdre DeJean for providing methodological input for the Perspectives and Experiences Review and for critically reviewing drafts of the protocols and drafts of the ethical issues analysis and the Perspectives and Experiences Review

Brit Cooper-Jones for formulating the key messages for broader public understanding of CADTH’s assessment on remote monitoring

Paula Murray for providing project management support.

The authors would also like to thank the external stakeholders who submitted feedback on the draft report.

External Reviewers

These individuals kindly provided comments on a draft version of this report.

Krisan Palmer, RN

Regional Telehealth Director and Clinical Lead

Horizon Health Network, Saint John, New Brunswick

Olivia Magwood, MPH, PhD(c)

Research Associate

Bruyère Research Institute

Ottawa, Ontario

Conflicts of Interest

Duncan Steele disclosed a financial interest (i.e., stocks) in UnitedHealth Group. No other authors declared conflicts of interest.

Key Messages

• Remote monitoring is a type of telehealth whereby health care is delivered to patients outside traditional settings by allowing health data to be exchanged between patients and health care providers using telecommunication techniques (e.g., video conferencing) or stand-alone devices (e.g., portable heart rate monitors). The goals of remote monitoring centre around promoting home-based self-management to improve patient outcomes and/or reduce health system usage.

• CADTH’s Health Technology Assessment included the following analyses:

  • A Realist Review: This sought to identify key perceived or actual mechanisms of remote monitoring programs. Substantial evidence was available regarding the use of remote monitoring programs for heart failure (n = 64) and cardiac rehabilitation (n = 23), limited evidence was available for atrial fibrillation (n = 4), and none was available for hypertension.

  • A Perspectives and Experiences Review: This thematic synthesis of primary qualitative research sought to understand and describe peoples’ experiences with and perspectives on remote monitoring programs for cardiac conditions. CADTH also engaged patients and caregivers directly in a patient engagement section.

  • An Ethics Review: This sought to identify and reflect upon key ethical issues that should be considered when contemplating the implementation of remote monitoring programs.

• Overall, the vast majority of sampled patients, caregivers, and health professionals consistently found or perceived remote monitoring programs across different cardiac conditions to be easy to use and beneficial to health.

• Remote monitoring programs may be an attractive adjunct as opposed to an alternative to existing health professionals and services.

• Although remote monitoring programs may ultimately reduce avoidable hospitalizations, they may increase net costs and workload during set-up and operational phases without careful pathway design and expectations management.

• More research is needed to identify the costs and cost-effectiveness of remote monitoring programs across chronic cardiac conditions.

Abstract

Context and Decision Problem

Remote monitoring is a type of telehealth whereby health care is delivered to patients outside traditional settings by allowing health data to be exchanged between patients and health care providers using telecommunication technologies (e.g., video conferencing) or stand-alone devices (e.g., portable heart rate monitors). The goals of using remote monitoring centre around promoting home-based self-management to improve patient outcomes or reduce health system usage. These outcomes are, in turn, theorized to enable patients to continue living at home and in the community.

Remote monitoring programs offer a potentially compelling alternative and supplement to traditional face-to-face health care for people in Canada with chronic cardiac conditions. Prior to the COVID-19 pandemic, remote monitoring for cardiac conditions was being studied in a number of projects and jurisdictions across the country. Since the COVID-19 pandemic began, interest in, demand for, and use of virtual care for patients with cardiac conditions (which includes remote monitoring) has increased. Jurisdictions across Canada have announced new funding for programs and clinician groups have produced guidance to support the implementation of patient care at a distance.

Based on jurisdictional feedback gathered by CADTH, the stage of diffusion of remote monitoring programs for people with cardiac conditions varies across the country. As such, while there is broad interest in the topic, the needs of each jurisdiction vary greatly. There is also uncertainty about which patients would benefit from participation in remote monitoring programs. Jurisdictions are faced with the question, how should remote monitoring programs for patients living in rural, remote, and urban settings be implemented? One driver behind this problem is a desire to provide care to patients in their homes or communities, minimizing the need for patients to travel or be transported from their homes to the hospital.

Realist Review

Methods

A Realist Review was conducted to identify key perceived or actual mechanisms of remote monitoring programs for adult persons living with a chronic cardiac condition or post-cardiac event, or persons who care for those living with a chronic cardiac condition or post-cardiac event. To be included, studies had to contain data or themes reasonably interpreted as relating to program mechanisms.

Results

Remote monitoring programs across cardiac conditions were consistently found or perceived by the vast majority of sampled patients, caregivers, and health professionals (often 80% to 90%) to be easy to use and beneficial to health.

Across all conditions sampled, in terms of the key mechanisms, adequate program technology was necessary but insufficient to foster positive outcomes. To ensure program effectiveness, technology had to integrate well with patients’ daily life patterns and homes, and promote understanding in patients not only of their condition but also of their personal health status. The main issues around technological uptake related far less to general fears about the technology than to frustrations around common but technically straightforward issues; notably, unstable connectivity of devices and poor battery life.

For cardiac rehabilitation, programs were seen to focus predominantly on promoting healthy lifestyle behaviours, with the capacity of technology to facilitate these outcomes being dependent on their ability to integrate with patients’ life patterns. Programs were most effective when motivated patients received highly individualized program content and components and leveraged existing strengths in relationships between health care providers and patients.

Patient experiences of heart failure were far more ambiguous, and programs were seen to provide vital support for daily ongoing self-care and knowledge. Programs tended to be more complex; nevertheless, the programs were most effective when technological aspects of programs were easy to use, supported adequately, and, crucially, were highly unobtrusive in patients’ lives. Similar to cardiac rehabilitation programs, heart failure programs were viewed as adjuncts to, not replacements for, traditional face-to-face health care provision; however, unlike cardiac rehabilitation programs, remote monitoring programs for heart failure provided more useful knowledge to interpret symptoms and guide self-care daily.

Evidence regarding atrial fibrillation programs was scant but ease of technological use guided patients’ uptake of platforms and was also seen to complement face-to-face health care.

Perspectives and Experiences Review

A thematic synthesis of primary qualitative research was conducted to understand and describe peoples’ experiences with and perspectives on remote monitoring programs for chronic cardiac conditions and cardiac rehabilitation.

Ideas around age and technological literacy were commonly raised by people living with cardiac conditions as a reason for being disinterested or unable to participate in remote monitoring programs. When people encountered technological challenges, they expressed being discouraged from adopting and using remote monitoring. Having informal caregivers, particularly adult children, who could help troubleshoot the technologies helped them overcome these hurdles. Sometimes the challenges were not with the use of the technologies but with the physical installation of the equipment itself, which meant finding the space and having the necessary connections, which was not always easy or possible, depending on peoples’ housing arrangements. These findings point to opportunities to develop programs that account for and anticipate potential challenges and provide the needed level of support and technological options that facilitate engagement with remote monitoring technologies.

Many people living with chronic cardiac conditions articulated an openness to taking greater responsibility for their own health through self-management. This required people living with cardiac conditions to make connections between their measurements and their behaviours over time. The self-management of medication required more guidance and support from health care providers in order for people with chronic cardiac conditions to become confident in changing their dosages or medications. Remote monitoring played a critical role as an external motivation for their self-management as it required them to be accountable and provided them with reminders. Once they discontinued remote monitoring programs, people described struggling with or giving up on monitoring their condition and lifestyle changes. These findings highlight the need for programs to provide adequate time to facilitate the process of self-management as well as the potential for longer-term technologies to support motivation and provide reminders.

People saw remote monitoring programs as a means of providing security through being watched, particularly for those with heart failure, and a way of accessing health care and fostering a closer connection between providers and patients. Providers and patients alike appreciated the ways that remote monitoring programs fostered people living with cardiac conditions to be more involved in their care. These findings suggest that remote monitoring was not an addendum to care but was experienced as a model of providing health care for patients with chronic cardiac conditions.

Providers’ experiences and expectations with remote monitoring embodied views of remote monitoring as both taking time and reducing time. Remote monitoring was seen by providers as increasing the amount of time needed due to the increased number and length of consultations. On the other hand, providers described remote monitoring programs as saving time because of the ability to identify and address health concerns early. Workload, particularly caseload, was raised by nurses as a concern when programs underestimated or did not allow for adequate time for consultations. When remote monitoring programs were not technically or organizationally integrated into health care delivery, they presented challenges to providers. These findings reveal opportunities to maximize the success of remote monitoring programs by taking the number and length of patient consultations into account and ensuring appropriate integration, particularly with electronic health records, within health care systems.

Ethics Review

Methods

An ethical analysis was conducted, building from a literature review of articles with either explicit normative analysis of ethical issues arising in the use of remote monitoring, whether for the treatment of the conditions of interest or more generally, or empirical research that included ethical issues arising in the use of remote monitoring.

Results

The goals of remote monitoring programs are not always clear. For decision-makers to implement their program with a good chance of success, they should pause to assess what gaps exist in current care and what options exist to meet those needs (technological, human resource, transportation, others). This assessment should occur with the inclusion of the voices and perspectives of those who will be most impacted by the decision, and who will also play a key role in the uptake and success of the program. That should likely include patients (especially lower-income, non-White, non-male ones, who are less likely to be represented at decision tables), their informal caregivers, such as family members and spouses who often play central and critical roles, as well as general practitioners and cardiac teams.

Remote monitoring programs are often framed as a solution to provide care to patients in their own homes or communities, and to increase their access to high-quality services. Unfortunately, there is limited evidence about the effectiveness of various components of remote monitoring programs. These evidence gaps are most notable with rural or remote, racialized and Indigenous people, and people of low socioeconomic status.

Remote monitoring programs are not necessarily a solution to health access challenges. Attention should be paid to what costs are borne by patients or their families in the target population(s) and subgroups. What may be a small expense to some patients and their families could be an impossible barrier to others (e.g., transportation to clinic, internet provider at home).

Programs that involve private third-party technology raise concerns around privacy and informed consent. User agreements between patients and a third party may be challenging because the risks to themselves and their genetic relatives from their health and other information may not be clear or reasonably known. If such legal agreements are a requirement for patients to receive care, this raises concerns about freedom of choice.

Conclusions and Implications for Policy-Making

From a program design standpoint, the incorporation of highly individualized clinical information via feedback data to the patient on their condition and progress can maximize the effectiveness of remote monitoring programs for heart failure, atrial fibrillation, and cardiac rehabilitation. Program benefits were dependent on the program integrating well with each individual patient’s context: their daily habits and life patterns. Future remote monitoring programs for cardiac conditions should not only use technology appropriately and efficiently but also be sufficiently adaptive to different patients’ needs and designed to adapt to different patients’ home settings.

Limited evidence on remote monitoring programs delivered in rural or remote settings is significant from a public policy standpoint, given common assertions that these programs increase access to specialist care in rural and remote populations. Similarly, the gap in evidence around the perspectives, experiences, and needs of family and other informal caregivers is also significant. Decision-makers should consider the additional work and costs to patients and caregivers associated with remote monitoring programs. Further evaluation is needed to better understand the effectiveness of remote monitoring programs for cardiac conditions in predominantly rural or remote populations, and the impacts on family and informal caregivers.

There is little evidence on the potential moderating effects of patient age, sex and/or gender, race and/or ethnicity, and income on program usage and effectiveness. More emphasis should be placed on understanding the experiences of those who may be marginalized and/or have poorer access to technologies, including reliable high-speed internet, and who may experience discrimination in the health system. For Canadian decision-makers interested in understanding how remote monitoring programs could complement the care of First Nations, Inuit, and Métis patients, no component of this report identified evidence that included Indigenous people or was concerned with indigeneity. This evidence gap emphasizes the need for decision-makers to ensure that the voices of people who are often excluded or marginalized are included when designing, implementing, and evaluating remote monitoring programs.

Remote monitoring programs may be an attractive adjunct as opposed to an alternative to existing health professionals and services. Although programs may ultimately reduce avoidable hospitalization, there is a strong likelihood that without careful pathway design and expectations management, remote monitoring programs may increase net costs and workload for host providers during set-up and operational phases. More research is needed to identify the costs and cost-effectiveness of remote monitoring programs across chronic cardiac conditions.

Introduction and Rationale

Remote monitoring (also known as remote patient monitoring or remote patient management) is a type of telehealth whereby health care is delivered to patients outside traditional settings by allowing health data to be exchanged between patients and health care providers using telecommunication technologies (e.g., video conferencing) or stand-alone devices (e.g., portable heart rate monitors).^1,2 Canada Health Infoway has defined remote monitoring as “the delivery of [health care] to patients outside of conventional settings enabled by a technological application or device.”¹ The stated goals of using remote monitoring in clinical practice centre around promoting home-based self-management to improve patient outcomes or reduce health system usage.³ Self-management strategies typically aim to improve diet and cholesterol levels, exercise levels, knowledge of the patient’s health condition, confidence to stay at home, patient satisfaction, and quality of life. These outcomes are, in turn, theorized to lead to improved patient outcomes over time and to enable patients to continue living at home and in the community.³

At its core, remote monitoring relies on the use of telecommunication technology for the transmission of health data between patients and health care providers.² Examples of health data that may be transmitted include readings of physiologic activity such as oxygen saturation levels and cardiac rhythm or patient observations such as mental status and medication intake. For example, for patients with hypertension, blood pressure readings could be transmitted to evaluate treatment effectiveness and adherence. For the purposes of this HTA, CADTH considers a remote monitoring program to be a formal, organized offering from a health authority or health care organization that may employ a variety of technologies (e.g., video conferencing, blood pressure monitors, online portals) to collect and transmit patient data. This contrasts with the one-off use of remote monitoring devices (e.g., personal electrocardiogram devices) that may be used or prescribed by an individual clinician or clinician group.

Remote monitoring programs offer a potentially compelling alternative and supplement to traditional face-to-face health care for people in Canada with chronic cardiac conditions. The current base of trials evaluating remote monitoring programs continues to grow, but the type of evidence that these trials generate is often too general to be especially useful for local planning and implementation. This not only hampers local service design but also potentially harms patients and increases system-wide costs by failing to realize the potential of different remote monitoring techniques for different contexts.^4,5

This situation should not, however, lead to the rejection of remote monitoring for the large population of people in Canada with cardiac conditions. Trials over the past 20 years continue to indicate that remote monitoring programs for cardiac conditions are generally effective.^4,6,7 For example, programs for patients with a variety of cardiac conditions have been shown by randomized trials and meta-analyses to be effective at reducing adverse events (notably hospitalization) and improving quality of life^8-10 and have, for more than a decade, been found in systematic reviews to have comparable effects to site-based programs.¹⁰ That said, beyond these positive effects, the actual components of the remote monitoring programs remain poorly described in the vast majority of published trials^4,11 and meta-analyses.¹² Reviewing the body of remote monitoring programs for heart failure, this tendency has been said to contribute to a policy-maker’s nightmare due to the evidence being vast, fragmented, heterogeneous, of variable quality, and with no clear answers to the question of what technologies, supported by what service infrastructure, to provide for whom.

Those charged with designing or adapting remote monitoring programs for specific settings therefore lack an evidence base that is sufficiently specific to inform their decisions. More research is still needed to unpack which components of remote monitoring programs matter most in different contexts for different populations.

Remote Monitoring for People With Cardiac Conditions

In Canada, the number of people with heart failure is increasing annually, with more than 600,000 people currently living with the condition and more than 50,000 new cases diagnosed each year.^13,14 An estimated 350,000 Canadians live with atrial fibrillation,¹⁵ and more than 5.4 million Canadians have hypertension.¹⁶ Although many Canadians with cardiovascular disease would benefit from cardiac rehabilitation, only an estimated 10% to 30% have access to such programs.^17,18

Remote monitoring for people living with cardiac conditions has been proposed as a means of detecting health issues earlier while also reducing the need for routine office visits, emergency department visits, and hospital admissions.^19,20 Remote monitoring also aims to help patients maintain independence and remain in their home or community, which may be particularly relevant for patients living in rural or remote locations.^18,19,21,22 For conditions like hypertension, dozens of home monitors are readily available to patients.²³ Elsewhere in the remote monitoring space, several companies have drawn media and health care provider attention to low-cost, direct-to-consumer devices that are capable of monitoring heart rate, heart rhythm, and blood pressure at home.^24-27 Large telehealth providers have also emerged to support care for cardiac patients.^28,29 However, there remains uncertainty and gaps in the evidence surrounding the use of remote monitoring.³⁰ Remote monitoring also raises concerns about patient privacy and data security because of its reliance on data and internet connections.^18,22

Based on a comparison of various program objectives and characteristics, including duration,³ remote monitoring programs for people with cardiac conditions tend to be of 2 general forms: those that are without a pre-specified duration (e.g., ongoing monitoring) and those that are of a pre-set duration (between 4 weeks and 6 months). Remote monitoring programs of a shorter duration are designed to help patients improve their self-management, with the goal that improvements will last beyond the duration of the program. Ongoing remote monitoring programs are also designed to support self-management and can have the additional objective of improving the continuity of care through improved communication between care providers and patients.

Program activities can vary widely within remote monitoring programs for people with cardiac conditions. In general, they include processes that collect and transmit patient data, which is then evaluated and triggers a form of intervention.¹ Data collection and transmission varies by what is collected, how it is collected (e.g., by a device or by the person living with a cardiac condition), how it is transmitted, and when it is transmitted (e.g., frequency). The data, once received, can be evaluated by a health care provider or program staff, a third party, or an algorithm. Interventions vary in how they are provided and their scope, which can include medication adjustments, prompts to support a healthy diet, increased physical activity, and smoking cessation, or advice to seek in-person care.

The severity of patients’ conditions is important when considering remote monitoring programs for people with cardiac conditions.²⁴ This may be because, for remote monitoring programs to reduce health care utilization and to offset the expense of operating remote monitoring programs, it may be important to enrol patients who are at moderate or high risk of emergency department visits or hospitalization rather than enrol healthier patients.²⁴ Hence, many large-scale programs typically describe contact with health care services (e.g., 1 or more emergency department visits) as eligibility criteria.^3,24

Improved self-management of patients with chronic cardiac conditions through remote monitoring has been viewed as a means of reducing resource utilization across health care systems — including pre-hospital, emergency, acute care, and long-term care settings. These reductions in health care utilization are seen as both freeing up staff time (reducing pressures on health systems) and creating an opportunity for cost savings.³

Jurisdictions have expressed interest in an assessment of remote monitoring that explores the following patient groups: heart failure, atrial fibrillation, hypertension, and people eligible for cardiac rehabilitation.

Jurisdictions also expressed interest in an assessment of remote monitoring that includes rural, remote, and urban populations. CADTH’s Implementation Support and Knowledge Mobilization team indicated there is variability of cardiac care available to patients across the country, depending on the type of community in which they live. Therefore, remote monitoring programs may also have different impacts on patients in rural, remote, or urban settings.

Remote Monitoring Programs in Canada

Remote monitoring takes on particular salience in a geographically large country such as Canada, as it enables the delivery of health care outside of health care institutions and thus to patients who live remotely or rurally. In Canada, before the COVID-19 pandemic, remote monitoring of cardiac conditions was being studied in a number of projects and jurisdictions.^{1,18,21,22,29,31,32} In 2018, the Newfoundland and Labrador Centre for Applied Health Research completed an environmental scan that identified remote monitoring programs for chronic conditions in place across Canada and selected international jurisdictions to “inform the implementation and evaluation of [remote monitoring] for those living with chronic disease in remote and rural [Newfoundland and Labrador].”³ The authors identified 22 remote monitoring programs (or initiatives) active in the previous 5 years, 11 of which were in Canada and enrolled people with cardiac conditions. Of these 11 Canadian remote monitoring programs, some enrolled more than 1 type of patient group:

• 8 were available to people with heart failure

• 2 were open to people with hypertension and 1 for pulmonary hypertension

• 1 was for cardiac rehabilitation

• 2 were available to all people with chronic diseases

• 1 was open to all people in the province with a provincial health card.

These 11 remote monitoring programs were available to residents of British Columbia, Newfoundland and Labrador, New Brunswick, Ontario, Prince Edward Island, and Quebec. The scan also identified an additional 10 pilot remote monitoring programs or ongoing research studies from Canada. The environmental scan did not discuss barriers or facilitators to implementation, nor did it evaluate the remote monitoring programs identified.

Since the COVID-19 pandemic began, interest in, demand for, and use of virtual care for patients with cardiac conditions (which includes remote monitoring) has increased and research into the pandemic’s impact on the delivery of cardiac care is beginning to emerge.^33-37 Jurisdictions across Canada, such as British Columbia, Ontario, and Saskatchewan, announced new funding for programs (both pilot projects and ongoing funding) and clinician groups, such as the Canadian Cardiovascular Society, produced guidance to support the implementation of patient care (e.g., virtual cardiac rehabilitation) at a distance.^38-41

Based on jurisdictional feedback, the stage of diffusion of remote monitoring programs for people with cardiac conditions varies across the country. Some jurisdictions, such as New Brunswick, have well-established programs serving many different patient groups. Others, such as Manitoba and Saskatchewan, are just beginning to explore implementing remote monitoring programs for patients with cardiac conditions. As such, while there is broad interest in the topic, the needs of each jurisdiction vary greatly, depending on the level of adoption of remote monitoring technologies. There is also uncertainty about which patients would benefit from participation in remote monitoring programs. Because of existing work, jurisdictions indicated that additional assessment of remote monitoring programs for patients with implanted cardiac devices, such as implantable cardioverter-defibrillators, is not needed at this time.

Decision Problem

According to some jurisdictions, the implementation of remote monitoring technologies is not a question of if it will happen; rather, it is a question of when and how it will happen. Because of this (and the varied stages of diffusion), jurisdictions are faced with the question, how should remote monitoring programs for patients living in rural, remote, and urban settings be implemented? The driver behind this problem appears to be a desire — from policy-makers, patients, and health care providers alike — to provide care to patients in their homes or communities, minimizing the need for patients to travel or be transported from their homes to the hospital.

Objective

The purpose of this HTA is to address the decision problem through a series of analyses, including a Realist Review of remote monitoring programs for cardiac conditions; a qualitative evidence synthesis of the perspectives and experiences of those participating in remote monitoring programs for cardiac conditions, including patients, informal caregivers, and health care providers; and an analysis of ethical considerations. These analyses were informed by the results of a CADTH Environmental Scan of remote monitoring programs for cardiac conditions in Canada.⁴²

Research Questions

The proposed HTA will address the decision problem by exploring the following research questions:

• Realist Review

  1. What aspects of remote monitoring programs for chronic cardiac conditions or post-cardiac events influence patient and system-level outcomes, for whom, in what circumstances, to what extent, and why?

• Perspectives and Experiences Review

  1. For people living with a chronic cardiac condition or post-cardiac event, what are their expectations of, experiences with, and perspectives on remote monitoring programs?

  2. What are their families’ and care providers’ expectations of, experiences with, and perspectives on remote monitoring programs?

  3. How do people living with a chronic cardiac condition or post-cardiac event, their families, and their care providers experience and understand:

     • how to adopt and use remote monitoring technologies?

     • how remote monitoring programs move health care into peoples’ places of residence and what is the impact of this shift on the families of people living with a chronic cardiac condition or post-cardiac event?

     • the changes in roles and responsibilities that can accompany remote monitoring programs and what the impact of this shift is on the families of people living with a chronic cardiac condition or post-cardiac event?

     • how and when remote monitoring programs are seen as working or as not working?

• Ethics Review

  1. What are the ethical issues related to the implementation of remote monitoring programs?

  2. How might these issues be addressed in rural, remote, and urban settings?

Methods

To inform the conduct of this HTA, a preliminary scoping review of the existing literature — including HTAs and systematic reviews — was conducted. A protocol was written a priori, using appropriate reporting guidelines (e.g., the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols ([PRISMA-P]) for guidance on clarity and completeness. These guidelines were followed throughout the study process. Any deviations from the protocol were disclosed in this final report and updates were made to the PROSPERO submission accordingly (Realist Review: CRD42021229271; Perspectives and Experiences Review: CRD42020211271).^43,44

A Realist Review was conducted to identify key perceived or actual mechanisms of remote monitoring programs for adult persons living with a chronic cardiac condition or post-cardiac event, or persons who care for those living with a chronic cardiac condition or post-cardiac event (see Realist Review section for further details). For the Perspectives and Experiences Review, a qualitative evidence synthesis of primary qualitative research was conducted to understand and describe peoples’ experience with and perspectives on remote monitoring programs for chronic cardiac conditions and cardiac rehabilitation (see Perspectives and Experiences Review section for further details). For the Ethics Review, a bioethical analysis was conducted to identify and reflect upon key ethical issues when considering remote monitoring programs for adult persons living with a chronic cardiac condition or a post-cardiac event, or their carers (see Ethics Review section for further details).

Opportunities for Stakeholder Feedback

Stakeholders were given the opportunity to provide feedback on the draft report, and the recommendations, if applicable.

Realist Review

Research Question(s)

To inform decisions about how remote monitoring programs can work most effectively, the research question underlying this review is:

• What aspects of remote monitoring programs for chronic cardiac conditions or post-cardiac events influence patient and system-level outcomes, for whom, in what circumstances, to what extent, and why?

Key Messages

• Remote monitoring programs are known to generally improve life quality and expectancy in patients with chronic cardiac conditions, but little is known about how programs should vary by context or the mechanisms moderating interventions effects, or how these mechanisms vary by context. This Realist Review sought to identify studies providing insights into the main mechanisms of effect of different kinds of remote monitoring programs and to examine how context influenced these mechanisms and outcomes.

• Although the review identified only 1 dedicated realist evaluation, a sizable number of studies were identified that contained data on remote monitoring program mechanisms and/or contexts in studies examining programs for patients with heart failure (n = 64) and for cardiac rehabilitation (n = 23). A small number of studies (n = 4) addressed atrial fibrillation. No studies were identified focused on hypertension.

• Remote monitoring programs across all the cardiac conditions were consistently seen by the vast majority of sampled patients, caregivers, and health professionals in studies to contribute to positive remote monitoring health outcomes, particularly in psychosocial and behavioural outcomes.

• However, in terms of the key mechanisms and context explaining outcomes from studies, adequate program technology — while necessary — was insufficient to foster positive outcomes. Central to the positive effects of programs were mechanism-context synergies associated with the technology integrating well with patients’ daily life patterns and homes, and promoting understanding in patients not only of their condition but also of their personal health status. The main issues around technological uptake related far less to general fears about the technology than to frustrations around common but technically straightforward issues; notably, challenges around unstable connectivity of devices and poor battery life.

• For cardiac rehabilitation remote monitoring programs, programs were seen to focus predominantly on promoting healthy lifestyle behaviours with the capacity of technology to facilitate these outcomes being dependent on their ability to integrate with patients’ life patterns. Programs were most effective when motivated patients received highly individualized program content and components and leveraged existing strengths in relationships between health care providers and patients.

• Patient experiences of heart failure were far more ambiguous, and programs were seen to provide vital support for daily ongoing self-care. The remote monitoring programs tended to be more complex; nevertheless, the programs were also most effective when the technological aspects of programs were easy to use, supported adequately, and, crucially, highly unobtrusive in patients’ lives. Similar to cardiac rehabilitation programs, the remote monitoring programs for heart failure were viewed as complementary rather than as replacements for traditional face-to-face health care provision. However, unlike cardiac rehabilitation programs, remote monitoring programs for heart failure were seen to provide more useful knowledge to interpret symptoms and guide self-care daily.

• While evidence regarding atrial fibrillation programs was scant, there was some evidence here that ease of technological use guided patients’ uptake of platforms and was also seen to complement face-to-face health care. This was key for atrial fibrillation, given remote monitoring was seen to function to prevent relatively low-probability, although potentially high-risk, arrhythmia.

Methods

This Realist Review has been developed from an addendum⁴⁴ to the main HTA protocol.⁴³ The protocol was drafted ensuring attention to elements described in the Realist And Meta-narrative Evidence Syntheses: Evolving Standards (RAMESES) publication standards, as appropriate.⁴⁵ The protocol is registered with PROSPERO (CRD42021229271).

Study Design

A Realist Review was conducted to examine what works for whom, and when and why it works concerning remote monitoring programs for treatment and support of chronic cardiac conditions or cardiac rehabilitation.⁴⁶ For the purpose of this review, a chronic cardiac condition is defined as a physician-confirmed diagnosis of heart failure, hypertension, or atrial fibrillation. Realist reviews are appropriate for assessing how and why various aspects of complex interventions work, for whom, in what contexts, and to what extent.⁴⁶ Knowledge from a Realist Review provides useful and nuanced guidance for decision-makers in different contexts to inform local service design decisions.⁴⁶ This can, for example, better ensure that interventions to promote health and self-care of chronic disease have more consistent benefits across different patients and settings.⁴⁷ Accordingly, findings from realist reviews supplement and complement evidence from other methods (notably randomized trials and meta-analyses), which provide broad but less specific and useful evidence for decision-makers.^4,5 While such methods convey that a health services intervention may generally work,⁶ the generic nature of this evidence fails to convey the influence on intervention outcomes of where the program is provided (context), how it influences outcomes (mechanisms), and what about the intervention promotes effectiveness (components).⁴⁸

As an approach, realist reviews are grounded in the realist evaluation method,⁴⁹ which has its roots in critical realist philosophy⁵⁰ and complexity-driven methods and theory.⁵¹ These approaches share a rejection of research and theory that assume or imply that interventions such as policies, programs, or strategies involving behaviours influence outcomes in orderly, linear, law-like ways (e.g., intervention A leads to benefit B in population C).⁵² Instead, causality between the intervention and its effects is seen to be contingent on the effects of multiple factors — for example, related to patients, programs, and places — interacting to generate changes in outcomes.⁴⁷ Under this contingent approach to causality, even small changes in 1 element of intervention design (such as a component or subcomponent, or a characteristic of context) could generate large changes in a primary outcome.⁵³

Realist approaches to evaluation and review have profound implications for how health service interventions are conceptualized and researched. Accordingly, realist reviews focus less on making a judgment of the truth of a linear causal relation between 2 single variables (i.e., does x cause y?), and more on the complex ways in which x can cause y under conditions a, b, and so on.⁴⁶ As such, Realist Review methods can be used to tease out the mechanisms and contextual factors that enable interventions to lead to desired outcomes and can identify key circumstances under which a complex intervention can fail or lead to unintended outcomes.⁴⁶ This generative approach accounts for why interventions that ostensibly have the same components of design can have markedly different outcomes in different contexts⁴⁹ or, in randomized trials of disease management interventions, why the benefits of affirmative trials are often not replicated or scaled over time in different trials.⁶ Realist approaches view such variations as inevitable consequences of complexity⁵⁴ rather than weaknesses in interventions or study design, related to intervention design, provision, implementation, or fidelity.¹¹

Realist review aligns well with remote monitoring programs for chronic cardiac conditions because these interventions can be termed complex interventions due to the number and type of interactions between intervention components. This includes monitoring program components, the context(s) in which programs are provided, the technology program(s) used, the theory guiding design and content, and the frequency and intensity of monitoring.^54,55 Furthermore, program components can be conceived to be multi-faceted and interactive rather than singular and isolated,⁵³ with intervention effects understood to be generated from interactions not only between these components but also between these components and certain aspects of patients and the context of the intervention.⁵⁴ As such, realist approaches are highly suited to examining and explaining the effects of remote monitoring programs for chronic cardiac conditions.⁵⁶

Yet, crucially, the existing evidence base has tended to leave the modifying influence of program components, context, and mechanisms unexplored and unacknowledged. See examples in cardiac rehabilitation,^6,57 atrial fibrillation,⁵⁸ and heart failure.^6,59-61 This neglects and harms evidence quality,¹¹ reduces its usefulness to decision-makers,⁶² and ultimately fails to fully realize the benefits to cardiac patients in different settings of promising remote monitoring programs.⁴⁷

Specifically, therefore, this Realist Review explicates how context moderates the mechanisms of interventions to influence outcomes. Accordingly, the review assesses why remote monitoring programs for chronic cardiac conditions do or do not work in different contexts or circumstances, for different stakeholders, with different patient populations, and for different purposes. This was done by exploring the influence on intervention effects and effectiveness of aspects and interactions of intervention mechanisms, with a particular focus on how mechanisms are influenced by aspects of intervention contexts, components, and recipients (including patient characteristics) in published accounts of interventions for the most common chronic cardiac conditions addressed by health services: heart failure, hypertension, cardiac rehabilitation, and atrial fibrillation.

Research Methods

This Realist Review primarily followed Pawson’s (2005)⁴⁶ realist review methods, drawing on an interpretive approach to synthesis⁶³ that has been used successfully in a past Realist Review to identify the influence of mechanisms and context on remote and provider-based heart failure disease management interventions.^61,64 These approaches mirror those of systematic reviews of intervention effects (e.g., incorporating systematic and comprehensive searches, quality appraisal, and synthesis of findings) with some modifications to ensure efficiency and accounting for scoping work that has already been conducted and a defined HTA timeline, while reflecting the realist underpinning of the approach. Although the steps are described sequentially, in practice they were overlapping and iterative, responding to results as they emerged. The final results are reported using the RAMESES guidelines⁴⁵ for the reporting of realist evaluations.

The primary goal of the Realist Review was to consider how the effects of remote monitoring programs are influenced by aspects of context and intervention components via the influence of these key factors on perceived or actual intervention mechanisms. The realist synthesis identified studies using a comprehensive and detailed systematic search of published accounts of the mechanisms of remote monitoring programs for the most common programs offered for management, behavioural change, and self-care of cardiac conditions. Programs to be reviewed were for patients with a primary diagnosis (and reason for program referral) for heart failure, cardiac rehabilitation, atrial fibrillation, and hypertension, but could involve patients, family caregivers (e.g., partners, significant others), and health professionals. To explore the influence of program mechanisms with aspects of context, components, and patient characteristics on outcomes, this approach — as with other approaches to theory-building from qualitative data — generates findings that move beyond description to present a new interpretation of published literature. This can offer additional insight into the phenomena of remote monitoring programs.⁴⁶ An example is Clark et al. (2016).⁶⁴

Due to an anticipated lack of realist evaluations of remote monitoring programs for patients with chronic cardiac conditions, this review did not incorporate an extensive initial scoping of the literature or theory development as an integral part of the review, unlike other realist reviews.⁴³ However, those contributing to the development of questions drew on their knowledge of remote monitoring programs in this patient population, and the inclusion criteria and search were designed to ensure they included relevant documents. This reflects RAMESES publication standards for realist synthesis⁴⁵ because the search approach recognizes that the quality of a search in a realist synthesis depends on the “relevance and robustness of particular data for the purposes of answering a specific question” (p. 8).⁴⁵ Relevance refers to the ability of data to contribute to the development of testing of theory around the research question,⁴⁵ while rigour refers to the credibility and trustworthiness of these data.⁴⁵ Accordingly, the search sought data that could be of reasonable use to theory-building around program mechanisms — extending to those from qualitative and mixed-method studies, quantitative-process data, and grey literature, including program reports. All can conceivably contribute to “different ways of identifying and elucidating program theories” (p. 9).⁴⁵ As the number of documents identified in the search was large, the selection and appraisal stages were done in parallel with the synthesis stage.⁴⁵

Literature Search Methods

The literature search to support this Realist Review was performed by an information specialist using a peer-reviewed search strategy according to the PRESS Peer Review of Electronic Search Strategies checklist.⁶⁵ The complete search strategy is presented in Appendix 1.

Published literature was identified by searching the following bibliographic databases: MEDLINE All (1946‒) via Ovid, Embase (1974‒) via Ovid, APA PsycINFO (1806‒) via Ovid, the Cumulative Index to Nursing and Allied Health Literature (CINAHL) via EBSCO, and Scopus. All Ovid searches were run simultaneously as a multi-file search. Duplicates were removed using Ovid deduplication for multi-file searches, followed by manual deduplication in Endnote. The search strategy comprised both controlled vocabulary, such as the National Library of Medicine’s MeSH (Medical Subject Headings), and keywords. The main search concepts were chronic cardiac conditions, cardiac rehabilitation, and remote monitoring. Clinical trials registries were searched: the National Institutes of Health’s clinicaltrials.gov, Health Canada’s Clinical Trials Database, and the European Union Clinical Trials Register.

No filters were applied to limit the retrieval by study type. Retrieval was limited to English- and French-language documents published between January 1, 2010, and November 11, 2020. Conference abstracts were excluded from the search results.

The initial search was completed on November 11, 2020. Regular alerts updated the database literature searches until the initiation of the stakeholder feedback period. The clinical trials registries search was updated before the stakeholder feedback period was completed. Due to time constraints related to the project deadline, citations found through alerts were not screened or included in the analysis of the final report.

Grey literature (literature that is not commercially published) was identified by searching sources listed in relevant sections of the Grey Matters: A Practical Tool for Searching Health-Related Grey Literature checklist.⁶⁶ This includes the websites of regulatory agencies, HTA agencies, clinical guideline repositories, systematic review repositories, patient-related groups, and professional associations. Google was used to search for additional internet-based materials. These searches were supplemented by reviewing bibliographies of key papers and through contacts with experts and industry, as appropriate. The grey literature search was updated before the completion of the stakeholder feedback period. See Appendix 1 for more information on the grey literature search strategy.

Selection and Eligibility Criteria

The study eligibility criteria can be found in Table 2 using the Sample, Phenomenon of Interest, Design, Evaluation, Research type (SPIDER) tool.⁶⁷

Articles were excluded if they did not meet the selection criteria outlined in Table 2, did not contain data extractable specifically for chronic cardiac conditions or post-cardiac events, addressed single, one-off, or ad hoc remote monitoring techniques, or addressed hypertension associated with pregnancy. The review did not include studies published before January 1, 2010.

The approach to mechanisms proposed is important because mechanisms are defined poorly, narrowly, or not at all in many past realist reviews.⁶⁸ Nevertheless, these serve the vital explanatory function of accounting for why particular programs have the effects they do. In short, mechanisms “explain why the relationships come about… (and) establish what goes on in the system that connects its various inputs and outputs” (p. 1).⁶⁸ This definition reflects Pawson and Tilley’s (1997)⁴⁹ original program-focused approach in which “mechanisms describe what it is about programs and interventions that bring about any effects…as the workings of a clock (mechanisms) cannot be seen but drive the patterned movements of the hands” (p. 23).⁴⁹ As such, in this review, mechanisms are defined as referring to the “underlying entities, processes, or…structures which operate in particular contexts to generate outcomes of interest” (p. 372).⁶⁹

This definition of mechanisms is inclusive, credible (reflecting past approaches to defining mechanisms),⁶⁹ and ultimately useful. In short, it provides a fruitful basis for identifying how remote monitoring programs could be adapted for different settings. However, it is not straightforward in that mechanisms of programs may not be directly observable (though they can be inferred),⁶⁹ readily measurable (though they can be captured via qualitative data), or objective (though they can be perceived).⁴⁸ Furthermore, in health services interventions, research into mechanisms remains rudimentary and challenging — with mechanisms being defined, conceived, and researched in many different, often vague, ways — or lacking in any systematic definition at all.⁴⁸ That said, the presence and influence of mechanisms on outcomes can be inferred from both dedicated realist evaluations (i.e., studies collecting primary data using variations of realist evaluation) and studies using other methods that contain qualitative or quantitative data on mechanisms,⁴⁵ including studies of mechanisms and context in health services for cardiac conditions.⁶⁴

For many years, systematic reviews demonstrated that context was comparatively neglected in published accounts of realist evaluations.⁶⁹ This is a major weakness because the moderating effects of context on mechanisms are a core tenet of realist evaluation⁴⁹ and do appear to influence outcomes and mechanisms in health service programs for cardiac conditions.⁶¹ Given the relatively small number of existing published realist evaluations, it is unrealistic to identify clearly delineated, almost mathematical context-mechanism-outcome synergies as envisaged by some theorists⁶⁸ working in realist evaluation. However, as with mechanisms, the influence of context on mechanisms can be inferred for complex interventions for cardiac conditions from realist evaluations and qualitative, quantitative, and mixed-method studies.^45,61 As such, the review search focused on published accounts of mechanisms but in the identified studies, we explored instances in which context has been found to moderate these mechanisms.

Study Selection

Due to the high number of articles the search identified during the preliminary search stage (level 1), 4 reviewers working in 2 dyads independently screened titles and abstracts in DistillerSR⁷⁰ against the predetermined inclusion criteria (Table 2). If the reviewers could not judge that the articles were clearly relevant from the titles and abstracts alone, full-text copies of articles were obtained for more detailed screening (level 2). The reviewers in each dyad compared their chosen included and excluded studies; disagreements were recorded and discussed with a fifth reviewer (a project leader) until a consensus was reached on selection.

A pilot exercise was undertaken between the 4 reviewers to test the screening procedures and inclusion criteria with a cohort of 5 randomly selected papers. A project leader checked the accuracy and consistency of the reviewers’ screening and selection decisions. Feedback was provided to reviewers throughout the screening process.

Data Extraction

Data extraction was performed by the project leaders. For each study included in the review (from levels 1 and 2), 1 project leader performed data extraction using a standardized data extraction template within DistillerSR.⁷⁰ For each included study, the second project leader checked the data extraction for completeness and accuracy. Omissions or disagreements were recorded and discussed by the 2 project leaders and resolved by consensus.

The data extraction template was developed by 1 project leader within DistillerSR,⁷⁰ using a form developed for a previously funded Realist Review of disease management interventions for heart failure⁶⁴ as a guide. Where possible, categorical fields were used. The extraction template was pilot tested by the second project leader using 3 randomly selected articles. Amendments from the pilot extraction stage were made before commencing extraction for the full review.

For each included study, the following details were extracted, and missing data were noted:

• publication title

• first author

• full citation

• main focus (heart failure, atrial fibrillation, hypertension, cardiac rehabilitation)

• program recipient(s) (patient, caregiver, health professional, other)

• method category (qualitative, quantitative, mixed, unclear)

• qualitative (general, grounded theory, ethnography, critical, experiential, other)

• quantitative (survey, trial, case control, cohort, other)

• country of setting

• inclusion criteria

• population studied (inpatient, outpatient, community)

• sex of sample (male or female)

• mean age

• recruitment method (volunteer, snowball, purposive, random, other)

• data collection method (face-to-face interview, telephone interview, online interview, focus group, measurement, other)

• remote monitoring components (telemonitoring, home telehealth, data transfer, other)

• remote monitoring adjuncts (home visit, clinical visit, none)

• data transfer (electrocardiogram, blood pressure, heart rate, body weight).

Data pertaining to mechanisms (including possible variations by context) in the form of verbatim data or themes were cut and pasted from published studies into a field in DistillerSR.⁷⁰ For qualitative studies, data were derived from themes or data relating to mechanisms, while for quantitative or mixed-method studies, primary numerical data were extracted from each study that was interpreted as giving insight into underlying mechanisms. In deciding whether data or themes were pertinent to the synthesis, project leaders considered if the identified data offered an explanatory account of what was going on between the intervention(s) and its outcomes (stage 1 synthesis as follows). As such, data or themes were not necessarily specifically labelled as pertaining to mechanisms in study reports, but reasonably interpreted as pertaining to mechanisms of remote monitoring aspects of interventions for cardiac conditions to be included.

Critical Appraisal

Realist reviews should report the overall strengths of evidence supporting the explanatory insights that emerged.⁴⁵ Consequently, to assess the merits of the research, the project leaders appraised the quality of each included study using the appropriate quality appraisal tools from the Centre for Evidence-Based Medicine (University of Oxford) for qualitative and quantitative studies (Critical Appraisal Skills Programme [CASP])⁷¹ and the Mixed Methods Appraisal Tool for mixed-method studies.⁷² These tools are narrative-based (i.e., they do not compute a quality score). The quality of each study was categorized independently as low, moderate, or high using the appropriate CASP tool of quality appraisal, with project leaders resolving disagreements until a consensus was reached. The papers were screened against quality criteria but not excluded based on quality, given long and ongoing disagreement over the use of quality criteria to appraise research.⁷³ Each project leader acted as a primary quality appraiser for half of the finalized cohort of included studies and as the second check for the other project leader. Disagreements in critical appraisal were discussed and resolved by consensus.

Data Analysis and Synthesis

Data synthesis was carried out by the 2 project leaders. The approach to analysis and synthesis used was employed in a previous Realist Review into the mechanisms of disease management interventions for heart failure.⁶⁴ As was the case with this past review, qualitative and quantitative data are useful in understanding mechanisms of remote monitoring interventions. Consequently, both types of data were synthesized. Though necessary, this is challenging because the synthesis of qualitative and quantitative research together remains relatively new; also, mechanisms usually have to be inferred or interpreted from these data as opposed to being clearly labelled in studies.⁶⁹ To address these challenges, a combination of established approaches to identify main mechanisms was used: the realist synthesis approach⁴⁶ and meta-ethnography.⁶³

Stage 1

Each project leader read each study in the final cohort to identify or infer the main mechanisms in the studies and extract data as described previously. These mechanisms were those for which data could reasonably be interpreted as speaking to the presence of the influence of mechanisms. Two types of data were extracted: qualitative data relating to mechanisms and quantitative data that yield clues of underlying mechanisms.⁷⁴ For qualitative studies, data were derived from themes or data interpreted reasonably as relating to mechanisms (even if not overtly labelled as such in studies). As per guidance for the systematic review of mechanisms, in a manner similar to meta-synthesis,⁶³ the project leader extracted the same words and terms as the original studies as much as is possible when extracting these subjective data around mechanisms.⁴⁶ For quantitative studies, primary numerical data were extracted from each study that is interpreted as giving insights into underlying mechanisms with a narrative “qualitized” account of what these data refer to. In the qualitative and quantitative studies, data and themes were extracted related to mechanisms, irrespective of whether these data are self-identified by authors to constitute mechanisms. This is normal in realist evaluation when mechanisms are theorized or inferred from data.⁷⁵

Stage 2 (Second-Order Coding)

After data were extracted for each included study, each project leader examined the initial mechanisms and study descriptions identified during stage 1 and, using the meta-ethnography method, met to discuss emerging main mechanisms from the stage 1 synthesis that existed across studies. Using conceptual mindmaps,⁷⁶ findings were translated and synthesized for both the qualitative and quantitative data into a core set of qualitative data about the nature of the main mechanisms more common or influential across studies, as well as how aspects of context influenced these mechanisms (recorded in Matrix 1). Studies were re-read in light of this emerging interpretive account and re-organized or interpreted as necessary via reflection, refutation, and clarification in a process of theory refinement. Hence, as per meta-ethnography,⁶³ data from different types of studies were triangulated and interpretations were applied to the extracted data across the studies. The approach to theory development was discursive, with emerging themes and theorizations discussed extensively and resolved by consensus.

A matrix (Matrix 2) was used to organize data on mechanisms and study details for this stage; separate sections recorded mechanisms linked to key factors, such as, but not restricted to, sex, age, and disease type or severity, and were analyzed by the project leaders independently.

Stage 3 (Synthesis)

As with Noblit and Hare (1988),⁶³ the project leaders generated the final synthesis account with an interpretive analysis⁷⁷ of Matrix 2 to generate an account of the main mechanisms acting in each type of intervention and a description of how each is affected by context and populations. This synthesis is presented in the Results section.

Rigour and Methodological Uniformity

Although the data on mechanisms are heterogeneous and potentially difficult to identify, meta-ethnography was also used to identify mechanisms using primary qualitative and quantitative data, and it is well-suited for examining the mechanisms of interventions for cardiac conditions — an effort for which literature is not primarily grounded in the social sciences.⁴⁸

Results

Quantity of Research Available

A total of 13,747 citations were identified in the literature search. Following screening of titles and abstracts, 13,461 citations were excluded and 286 potentially eligible reports from the electronic search were retrieved for full-text review. Of these, 195 publications did not meet the eligibility criteria and were excluded. A total of 91 studies,^78-168 reported in 91 publications, met the inclusion criteria and were included in this report. Twenty-three studies focused on cardiac rehabilitation populations,^78-100 64 on heart failure,^101-164 and 4 on atrial fibrillation populations.^165-168 No studies were identified addressing hypertension in the chronic cardiac populations. The study selection process is outlined in Appendix 2 using a Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)¹⁶⁹ diagram (Figure 1). Lists of included and excluded citations, with details describing the rationale for those excluded, are presented in Appendix 2, Table 9 and Table 10, respectively.

Study Characteristics

The studies included a total of 13,165 patients (8,697 males and 4,468 females; mean age = 66.35 years, standard deviation = 8.14 years), 72 caregivers, and 841 health professionals. Additional details regarding the characteristics of included publications and their participants are provided in Appendix 2.

Data were derived from a rich mix of qualitative (n = 23), quantitative (n = 54), and mixed-method (n = 14) studies. While the majority of studies were carried out in the US and UK, 9 studies recruited samples from Canada.^{79,82,108,111,123,127,134,137,164} Two studies were conducted in more than 1 country.^128,145 Two studies recruited participants exclusively from rural areas,^80,96 both in Australia. The review included 2 studies that only recruited women as participants,^{95, 118} whereas there were no studies that only recruited men.

Summary of Critical Appraisal

As per the RAMESES reporting guidelines,⁴⁵ it is important to identify the characteristics of the documents included in the review. Only 1 study included was a realist evaluation,¹¹³ but all documents included in this review contained empirical data pertaining to mechanisms or contexts of remote monitoring programs that were published in full papers in commercial journals. Based on the volume of data and study designs, 3 out of 91 studies (3.29%) had high quality of data on mechanisms, 25 studies (27.47%) had medium quality of data on mechanisms, and 63 studies (69.23%) had low quality of data on mechanisms. Details by study are presented in Appendix 2, Table 10.

Data Synthesis

Cardiac Rehabilitation Remote Monitoring Programs

The second largest proportion of studies was identified for patients with various forms of atherosclerotic cardiovascular disease,^78-100 defined as patients with a chronic cardiac condition after a cardiac event and/or in relation to a cardiac rehabilitation or secondary prevention program (collectively termed “cardiac rehabilitation programs” henceforth).

Patient Views of Outcomes: Health Behavioural Change

Across the studies, the remote monitoring programs for cardiac rehabilitation were seen to be focused on health behavioural change,^{78,79,82,88-90} with few participants focusing on benefits for self-care.^82,86 Conversely, the lack of acknowledgement in programs even linking death to heart disease was cited as a problem.⁸⁸

Generally, positive accounts of the benefits of programs were far more dominant and common than negative or harm-focused data and themes. There was a strong and consistent sense from patient users of the beneficial effects of programs on their general health^78,82-84,87 and motivation to maintain their general health.^78,82-84,87 These outcomes included:

• perceived or actual general psychological benefits^78-85

• greater motivation^78-84,86

• a higher sense of confidence^79,82,83 or self-efficacy^83-85

• a higher level of personal safety^82,84 and reduced anxiety.^79,83,86

Mainly, such benefits were invoked more generally but they were also invoked in relation to particular aspects of the interventions, such as text messaging⁷⁸ or using pedometers.⁸¹ The programs could foster a sense of hope that recovery and a healthier life was possible.^83,88

In terms of possible harms, no evidence of concerns over low safety of engaging in remote monitoring programs were raised in the studies. Indeed, high safety was seen to be an asset for some remote monitoring programs,^82,84 with attendant levels of personal vulnerability being notably low.^79,82-86

Based on this inclusive approach to what constitutes outcomes, the following key mechanisms-context synergies were the ones most predominantly associated with improvement in mechanisms.

In terms of access, remote monitoring programs were seen to be absolutely^79,90,91 and relatively^78,92 more accessible and to continue longer⁸⁷ than face-to-face alternative programs. This led participants to having strong positivity regarding remote monitoring programs — for example, via having a sense of being lucky,⁸³ being a priority,⁸⁹ or having greater access to health professionals.^89,90 These advantages were seen to hold despite individual variations in familiarity and prowess with the technical aspects of programs.

Key Mechanism and Context: Patients

Good Technology but Still Must Fit With My Life: The benefits of these remote monitoring programs for cardiac rehabilitation gained most value only when programs integrated well with facets of users’ own life context — that is, their daily life patterns, work, and aspirations. Remote programs were seen to more easily offer more life convenience and flexibility than traditional onsite programs.^79,82,85,90 The remote monitoring programs were seen to take less time away from daily life patterns,^82,83,90 require less disruptive transport,⁹⁴ and also support users to integrate personal travel into their life^82,83 while also leaving them feeling more connected to their community⁸² and broader social roles.⁹⁴ As such, effective programs facilitated patients’ ability to feel more connected but less grounded by the requirements of the program.

Despite the programs studied often incorporating a range of heart and activity monitoring components (commonly blood pressure, heart rate, and physical activity monitoring), challenges, concerns, and resistance around the remote monitoring technology was comparatively rare across the studies, including those specifically reporting on technical satisfaction.^93,95 Programs with more components could even be found to be positive.⁹⁶

In terms of common technical difficulties, the most commonly cited difficulties with the technology related to aspects of connectivity rather than the programs or content per se, with signal disruption between devices^91,93 and shortness of battery life^91,93 being the most common issues consistently identified. No technical aspects of the remote monitoring programs were consistently found to be burdensome or otherwise contribute to negative outcomes. Generally, instances or reports of technical failures were rare in the studies — 70% to 80% of patients reported having no technical problems.^93,95

Overall, technology was seen to promote effective cardiac rehabilitation.⁷⁸ Across the different studies, there was evidence of users deriving benefit from the full range of components of remote monitoring programs. For example, text messaging was seen to keep users engaged,^78,87,92 while videos of expert health professionals discussing heart disease^78,84 promoted knowledge and confidence via feeling well informed. The information provided on the programs was particularly valued when it was not a generic web page⁹² but was tailored to be understandable,⁷⁸ detailed,⁷⁸ and then trustworthy.⁷⁸ Likewise, feedback that was understandable was linked to behavioural change.⁹⁸ Wearables and blood pressure monitoring devices were perceived to be comfortable and easy to use.^91,98 Pedometers were noted to be useful in fostering in users a valuable and immediate sense of their progress.⁸¹

The Power of Individualization and Necessity of Motivation: Programs were most effective when they were perceived to provide highly tailored or individualized content for each patient. There was a consistent sense across studies that remote monitoring technologies could not only incorporate a high degree of individualization for each patient in terms of content and feedback, but that this was seen to be a central aspect to program benefits. For example, programs were seen to be able to be and stay responsive to participants’ highly personal and individual goals,^{80,81,85,88,91} and able to adapt to variability⁸⁸ and to the individual’s progression over time.⁹¹

Individualization could be increased via technological and interpersonal aspects of the programs — notably, via the provision of personalized health data to users on performance,⁸⁴ the tailoring of information to specific levels of understanding,⁸⁸ or follow-up with in-person health professional consultations to supplement the remote monitoring programs.⁸⁰

While there was a prevailing sense that remote monitoring would benefit most cardiac patients,^78-84,86,87 benefits were seen to be contingent on a number of contextual patient-related factors. Irrespective of individualization, successful patients were seen to possess sufficient self-motivation,⁸³ seriousness,⁸³ and honesty.⁸³ They had to have sufficient time⁸² and commitment⁸⁶ to work with the remote monitoring technology.

Harnessing Health Professional Relationships, Ignoring Patient Relationships: Instead of seeing the remote monitoring program as being distinct from patient care, patients perceived that programs fostered higher-quality and quicker connections to their own health professional multidisciplinary team.^89,90 Programs contributed to closer relationships with health professionals involved in their rehabilitation and/or preventive care^79,83 — a connection that was also cited as a reciprocal benefit by professionals^79,81,89 as augmenting the care they could provide.

Conversely, the most consistently cited negative aspect of remote monitoring programs was the lack of incorporation of or exposure to other patients in the remote monitoring programs,^{78,84,85,88,91} though other studies overtly disagreed with this, seeing lack of interactions as an advantage.⁹⁰ Other patients were seen to provide valuable sources of social camaraderie via shared experience,⁷⁸ social interactions,⁸⁴ and social comparisons⁷⁸ and functioning.⁹⁹ The lack of this relational aspect in remote monitoring programs was seen to compromise program effectiveness.^78,84,90,99

Context in Cardiac Rehabilitation Programs: No Influence of Demographic Factors

Few studies examined sex and gender effects specifically. In relation to sex and intersectionality, while cardiac disease burden and symptoms were found to be higher in women,¹⁰⁰ sex was not found to influence outcomes.⁸⁷ No studies explored the influence of race or Indigenous status on program use or effects. Older adults were seen to potentially need more support for the use of remote monitoring programs.⁷⁸

Age was found to be an actual barrier to remote monitoring program use in some studies^78,83,86,92 but not others.^87,91 These findings were based on cultural assumptions about technology familiarity being higher in younger people.^78,83 Other patient-related barriers identified as inhibiting positive outcomes were related to the lower likelihood of older patients choosing remote monitoring programs over face-to-face options,^78,86,92 lower access in those of lower education,⁸⁶ income,⁸⁶ and physical activity.⁸⁶

Heart Failure Remote Monitoring Programs

The largest proportion of studies of remote monitoring programs meeting the inclusion criteria focused on heart failure populations.^101-164 Similar to cardiac rehabilitation programs, data or themes in the studies of remote monitoring programs for heart failure did not indicate that the ultimate outcomes of programs were to lengthen life or reduce avoidable hospitalization. However, in contrast to cardiac rehabilitation programs, self-care due to heart failure was predominantly viewed as the key goal of programs — with program quality being primarily appraised or viewed around this outcome in many studies.^101-114 Only 1 included study noted that patients addressed or even mentioned death as a possible heart failure outcome.¹¹⁵

Patient Views of Outcomes: Heart Failure Self-Care

Programs were perceived in a large number of the studies to have a consistent and meaningful positive impact on a range of facets seen to be pertinent to or congruent with effective heart failure self-care. For example, in addition to being generally effective,^{102,103,105,116,162} the remote monitoring programs for heart failure were seen by patients to improve:

• knowledge of heart failure and its effective self-care^{101,105,110,111,113,117-123,163}

• patient confidence in self-care^104-114

• perceived patient safety^{106,109,116,124}

• patient anxiety.^123,125

These effects could be sustained over the long term.^107,119

In addition to these outcomes, benefits could be more process-related and subtle, such as fostering a new-founded realization of the real daily connection between self-care behaviours and consequential daily symptoms^112,123,163 — behaviour was recognized to directly influence biology and symptoms. Other effects extended to various psychological and social aspects, such as a higher sense of personal accountability,^106,123 control,¹²³ empowerment,¹²³ and motivation^{103,112,123,126} to self-manage heart failure. That said, expectations regarding how much the programs improved self-care could be high and unmet.¹⁵²

Professionals’ Views of Outcomes: Disease Management and Health Systems

The remote monitoring programs were seen by health professionals as making faster and more responsive heart failure care possible for worsening symptoms,^{109,123,124,127,128} and allowing professionals to focus their clinical consultations on key areas.^106,108 Patients also perceived the remote monitoring programs as improving links to health professionals via providing “live” access to their personal health data^101,129 and a range of care improvements, including assessment,¹²³ communication,¹⁰⁶ and clinical decision-making. Commentary on rural settings was restricted to programs being seen to promote cheaper and easier access for rural patients (who needed to travel further to outpatient clinics).¹²³

Although the patient benefits were not directly questioned by the health professional accounts, health professionals across a number of studies (notably nurses) cited a number of unintended negative consequences of programs on their wider work and capacity. These negative consequences included the workload around the remote monitoring technology set-up in patients’ homes,^106,130 increased general work flow accruing from program alerts and follow-ups,^{108,127,128,130,131} and, paradoxically, a higher sense of ongoing responsibility for patients who were at home.^124,131 Additionally, programs were seen by professionals to foster higher dependence and expectations in patients around health professional support.¹⁰⁶ As a monitoring tool that complemented, but did not replace professionals’ support,^130,132 programs were seen to contribute to inadequate remuneration for heart failure care provision.¹²⁷ Although only 1 study was a realist evaluation,¹¹³ the studies presented insights into a number of intervention mechanisms (Table 3).

Key Mechanism and Context: Health Providers

Remote Monitoring Programs Work in Tandem With Physical Care Settings and Teams: In contrast to the cardiac rehabilitation programs, recipients of the heart failure programs saw the programs as being complementary rather than a replacement for care from health professionals.^{104-106,108,118,120,123,127,129,133-136,163} This could be related to improving health professional access to their personal data,^101,129 and the constancy of the reassurance that the professionals were potentially at hand if needed.^{106,109,123,133,136} As such, the programs functioned within rather than outside of relationships between patients with heart failure and their health professional team.^{101,120,130,135-137,163} Furthermore, the remote monitoring programs added value to the patient-professional dyad via providing new opportunities for individualized care, more dialogue, and detailed feedback between patients and their professionals:^{101,106,113,123}

It tends to eliminate one of the biggest problems of being sick and that’s a sense of isolation, because I know that there’s regular (ongoing) contact. So, if I’m not feeling well, I know I’m going to be getting a phone call and it seems to me that’s worth gold” (Patient #2) (p. 4).¹²³

The influence of this was also apparent when low patient usage of programs occurred when the anticipated increase in contact with health professionals did not subsequently occur.¹³⁶

Notably, these consolidated connections with health professionals did not reduce patient views of their own personal responsibility for managing their condition^112,113,133 — even when health professionals were seen to have primary responsibility for managing the heart failure.¹⁰⁶ As such, the remote monitoring programs were seen by patients to add value to the contributions of health professionals for patients by leveraging the quality and benefits of existing relationships between patients and their health professional team,^{104-106,108,118,134,135} including physicians.^120,129,163 This was associated directly with increased security^104,123 and a reassuring sense of surveillance¹²³ by the professionals.

From the perspectives of professionals, the leveraging of programs with their care had a range of positive benefits. These included increasing the overall speed of professionals’ responsiveness,¹³⁴ providing health professionals with better access to individual patient data on vital signs,^123,129 focusing patient-professional discussions,^110,135 increasing professionals’ involvement with family caregivers,^120,136 reducing family caregiver anxiety,^123,138 improving knowledge deficits,^128,138 and reducing overall disease burden for patients.¹³⁹

In contrast, remote monitoring programs were seen by health professionals to require high levels of the capacity of health systems to set up and implement. Health professionals could view remote monitoring programs as causing major disruptions to their work in terms of ensuring adequate monitoring of patient data,^{106,108,124,127,128,150} initial work in program set-up with individual patients,¹³⁰ and ongoing difficulties around performing patient assessment remotely outside of the direct physical presence of patients.^135,150 Fear was also expressed over inadequate remuneration for professionals in their handling of alerts.^127,150

Key Mechanism and Context: Patients

Technology Must Be Easy and Accessible, Yet Unobtrusive for Me: In studies involving systematic measurement, there was a consensus that the remote monitoring programs studied were valuable and easy to use for 80% to 90% of patients.^{107,109,116,129,131,132,140} Similarly, there was a strong and prevailing sense that the various remote monitoring program technologies — though diverse — were generally easy to use.^{106,107,109,110,113-115,118,129,131-133,141-143,163} This ease was directly linked to higher subsequent usage in some studies,^127,162 with smartphones identified as the preferred main access to the program.^120,162 This ease contributed to lower anxiety¹²⁴ and to normalizing personal health data.¹¹⁵ Set-up processes in patients’ homes that were well supported were particularly valued^103,143,144 and fostered motivation for self-care when they consisted of simple steps,^103,143,144 but reduced usage when they were seen to be technically complicated.¹³⁶

Most of the difficulties with the technologies in the programs cited by patients related to aspects of the technology malfunctioning or failing to accommodate patients’ needs, as opposed to the content or components of the programs being seen as irrelevant or unhelpful. The technology could be seen by patients as obtrusive¹¹³ or unsuitable for technical novices.^104,141 This placed a heavy dependency on the availability of adequate technical support, which was seen by patients to be essential for programs to work well and was strongly linked to usage by patients^{112,113,124,127,132} and professionals.¹⁴⁴

As with the cardiac rehabilitation programs, the most challenging technological aspect of programs related to poor connectivity between equipment (notably from peripherals to smartphones),^{106,112,113,132,140,145-147} which inhibited data transfer.^132,143,148 Caregivers often had to help resolve these problems.^{104,109,127,147,148} In addition to being technically troublesome, these glitches reduced patient motivation to use the remote monitoring programs.¹³³ Reactions to technology of remote monitoring programs, while broadly very positive, could be mixed. Thus, device alerts could be interpreted as both helpful^108,138 but annoying when frequently false.^110,149

Conversely, system problems related to devices that were too noisy^106,108 or screens that were too big^106,113 and, thus, intrusive in the home setting. The realist evaluation in the studies reviewed identified that perceived intrusiveness could be the overriding determinant of subsequent patient use.¹¹⁰ In contrast, some patients with poor sight identified that screens were too small;^127,144 these concerns were shared by health professionals.¹⁵⁰

Other common problems cited included the high financial cost of broadband internet connections needed for equipment,^106,144,162 the low battery life of devices,^113,145 too many device alerts,¹²³ inaccurate results,^101,141,149 poor telephone mobility coverage,¹⁶³ lack of readily accessible technical support for patients,^113,140,163 installation or interfaces that were difficult,^144,148 and calibration and connection issues.^112,136,151 Problems also arose when patients attempted to use their own equipment¹³⁴ or caregivers also used equipment in the remote monitoring program.^141,149 While these technical issues could be seen to be more minor in significance, even a single factor that was not readily “fixable” (unlike a poor connection) could dramatically reduce perceived usability and patient usage. For example, when a single screen was seen to be too big for the home, this single facet was seen to constitute a major barrier in the home setting.¹¹³

Programs Must Integrate Into My Daily Life: The remote monitoring programs were seen to be beneficial because they facilitated the integration of health data and behaviours with daily life patterns around patients’ homes,^{101,104,112,118,123,133,164} perhaps reflecting the greater ubiquity of technology via smartphones with daily life in the 21st century. For example, patients would integrate daily weight monitoring on scales with their other set morning routines.¹³³

Programs Must Help Me to Understand My Condition: Heart failure was often confusing for patients,¹⁰⁴ or for those who had low foundational or prior knowledge.^{101, 113, 126} This lack of knowledge of heart failure was noted in the single realist evaluation to be a key mechanism affecting decreased usage of programs.¹¹³ Accordingly, to help make sense of their syndrome, patients strongly valued personal feedback in the form of data on their personal daily health status.^{103,106,113,118,123,131,136} Feedback was seen variously as promoting self-care behaviours,^103,113 a sense of each patient’s normal data patterns,¹⁰¹ and a greater sense of progress over time.^106,118,136 This individualized information was valued far more than general information on heart failure.¹¹⁸ Moreover, concerns about data security relating to data exchange of their health data were found to be very low.¹²⁷

At times, patients lacked sufficient knowledge to interpret data on the programs^104,136 (e.g., linking weight gain to their diet rather than heart failure)¹³⁶ or cited insufficient knowledge in how to use programs with confidence and without fear,^106,144 or understand how the data presented linked back to aspects of their heart failure.^133,136 Cognitive difficulties were cited as a barrier in only 1 study.¹⁴⁵ Some components could be used less often — for example, blood pressure if patients did not consider themselves hypertensive¹²⁷ — or past knowledge of aspects of self-care was very low, such as the need for sodium restriction.¹²³ Prior experience in using particular components, such as blood pressure monitoring devices or electronic weight scales, could increase usage.¹²⁷

Context: Sex and Gender, Age, Ethnicity, Rural Effects, and Caregivers

Data on aspects of context were comparatively low across the studies. Patient sex^121,125,153 and ethnicity were identified to have no effect on outcomes^121,153,154 — although Black patients had poor health at heart failure hospitalization¹⁵⁴ and tended to have symptoms at a younger age.¹⁴¹ Gender norms were cited in relation to male patients being more adept at handling technical complications with the remote monitoring programs via their past experiences in fixing electronic devices.¹⁰¹

Age profiles of patients did appear to be influential with mixed results, suggesting age had both negative effects on outcomes^101,137,155 and no effects.^121,126,153 Explanations offered for difficulties associated with age focused on how age influenced self-care — some studies indicated that age did not influence technology usage,¹⁰¹ or had a negative effect due to fear of technology linked to age,^126,144 or general poorer health.¹⁴³

Commentary on rural settings was restricted to programs being seen to promote cheaper and easier access for rural patients (who needed to travel further to outpatient clinics).¹²³

The type of heart failure (e.g., heart failure with preserved ejection fraction versus reduced or mid-range ejection fraction) was not found to influence remote monitoring program outcomes¹⁶⁰ but there was mixed evidence on the influence of heart failure severity on usage. Improvements in self-care were found to be higher in patients with poorer self-care at baseline¹⁶¹ — symptomatic New York Heart Association Class III heart failure participants were more likely to engage in self-care¹⁶¹ but were less confident in doing so.¹²⁰ This relationship between heart function and use¹⁵¹ and effectiveness was not found in other studies.¹⁵³ Mental health status (notably depression^109,143,156 and anxiety¹⁵⁶) was overtly linked to aspects of program usage, being associated with worse symptoms,¹¹² and with depressive symptoms being linked to worse outcomes.^109,156

Socioeconomic status was found to increase the likelihood of hospital admission during programs in some studies¹⁵⁷ but not others.¹⁵⁸ Concerns about the high costs of remote monitoring programs to patients were noted by some patients¹⁴⁴ and were linked to lower use of remote monitoring programs.¹⁶² Higher levels of education obtained were associated with higher confidence in using remote monitoring devices and higher subsequent usage rates.¹²⁰

Importantly, receiving remote monitoring care could be seen as being in total isolation to previous interactions with the health system related to heart failure. Previous heart failure admission was associated with improved program outcomes, with patients having received basic education on heart failure while in hospital¹⁰⁹ or at subsequent outpatient visits.¹⁵⁵

In terms of other factors, the size of the health care setting offering remote monitoring programs was not found to influence outcomes,¹⁵³ although programs offered in primary care or ambulatory settings were noted to have higher patient adherence.¹⁵⁹ Recommendations from health professionals for patients to use remote monitoring programs were seen to be especially influential in promoting the use of remote monitoring programs.¹⁶²

Notably, few studies included or explored how caregivers functioned around remote monitoring programs. Health professionals did cite that family caregivers were a vital complement to them around remote monitoring programs and should be actively involved in discussing care plans.¹⁵⁰ Very few studies addressed outcomes or impacts of the remote monitoring programs on family caregivers, with a small number identifying positive impacts on reduced caregiver anxiety¹²⁴ and short-term benefits.¹⁵⁰

Atrial Fibrillation Disease Management Programs

The number of studies examining remote monitoring for atrial fibrillation was much smaller than that of heart failure or cardiac rehabilitation remote monitoring programs. While, increasingly, technologies are being developed to monitor people for atrial fibrillation using apps and smartphones, only 4 studies^165-168 were identified that examined aspects of mechanisms that constituted remote monitoring programs and incorporated data exchange.

In terms of outcomes, the purpose of the programs was not well understood by patients,¹⁶⁶ although there was a more general sense that the programs were helpful in terms of health.^165,166 Devices were found to be useful in terms of identifying instances of arrhythmia¹⁶⁶ and providing prompts for medications¹⁶⁶ or health care consultation appointments.¹⁶⁶ Participants reported high confidence that programs would be helpful to them in future^165,166 by, for example, identifying future arrhythmia^166,167 and knowledge of new medications,¹⁶⁶ and allowing a means to record their own individualized history of arrhythmia.¹⁶⁶

Key Mechanism and Context: Patients

Ease of Use Leads to Enthusiasm: As with the heart failure programs, interfacing and using the atrial fibrillation programs was judged to be easy by the vast majority of patient participants across the studies.^165-168 Health professionals shared this high satisfaction.¹⁶⁸ Similarly, most participants reported high enthusiasm to use similar programs in the future.¹⁶⁵ Setting up systems to measure heart rate was identified as difficult by most participants in some studies.¹⁶⁶ Compared to heart failure programs, the purpose of the atrial fibrillation programs was considerably less well understood by patients,¹⁶⁶ perhaps due to a pervading general lack of seeing atrial fibrillation management as a primary life goal.^165-168 While data were scant, the most significant concerns about the remote monitoring programs for arrhythmia relate to their ability to accommodate patients of different needs, etiology, and history.¹⁶⁶

Technology: Leverages Patient Consultations: As with the heart failure programs, health professionals viewed the atrial fibrillation remote monitoring programs in the context of broader care — in this instance, viewing the atrial fibrillation programs as reducing the time burdens on them to personally perform tasks related to monitoring.¹⁶⁸ This was seen to promote their capacity to provide more comprehensive and individualized care.¹⁶⁸

No influence of context was examined in the papers containing data on mechanisms of atrial fibrillation programs.^165-168

Strengths and Limitations

Because of its strong focus on harnessing patient perspectives as users of programs, this review addresses an enduring, yet key, weakness associated with the underutilization of telehealth: the absence of patient users in informing the design and content of programs.¹⁷⁰

While this review was executed using quality standards for realist synthesis⁴⁵ and identified a number of key mechanisms and contextual considerations for future work, as with all reviews, it was constrained by the quality and design of the component studies. The overall quality of the included studies should be used to inform overall conclusions from the review, including recommendations for future research. Due to logistical constraints, the review only contained existing work published in English and French.

The volume of studies examining context and mechanisms together in the same individual studies was confined to 1 realist evaluation.¹¹³ As such, like past reviews into telehealth interventions for chronic disease populations,¹⁷¹ this review predominantly included studies using various methods that contained data on mechanisms or contexts.

In terms of future research priorities, more realist evaluations of remote monitoring programs for chronic cardiac conditions are needed. Where possible, study populations should include participants from the wide range of different rural and Indigenous communities.

In terms of other weaknesses, the studies consisted predominantly of evaluations of remote monitoring programs from high-income countries with more widespread availability of faster internet services for the remote monitoring programs. Similar programs may not be viable in countries or regions without such infrastructure. The predominant focus of studies on evaluating programs may have contributed to the overwhelmingly positive patient perspectives on programs in terms of ease of use and actual or potential benefits. In contrast, studies examining remote monitoring programs as part of routine care, such as via observational studies, were absent.

Only 1 study examined rural settings or populations only.¹²³ More studies of remote monitoring programs in Canada and beyond are needed to develop and evaluate remote monitoring programs for remote and rural settings.

Summary of Results

This Realist Review addressed how remote monitoring programs for various chronic cardiac conditions worked to promote changes in outcomes.

The key mechanisms and contexts described for remote monitoring programs in this review (Table 3) indicate that remote monitoring programs across cardiac conditions are consistently seen by the vast majority of sampled patients, caregivers, and health professionals in studies to contribute to positive remote monitoring program outcomes, particularly in psychosocial and behavioural outcomes.

However, in terms of the key mechanisms and contexts explaining outcomes from studies, adequate program technology was necessary but insufficient to foster positive outcomes. Central to the positive effects of programs were mechanism-context synergies associated with the technology integrating well with patients’ daily life patterns and home, and promoting understanding in patients not only of their condition but also of their personal health status. Framed in terms of “fit,” the central role in effective programs of adequate integration of programs with patients’ context concurs with previous realist reviews of telehealth interventions for chronic conditions.¹⁷² This also aligns with recent reviews into heart failure self-care, which point to the influence on outcomes of patient context⁶¹ and daily life habits.^173,174

Across the chronic cardiac conditions, programs were perceived by large proportions of those studied (often 80% to 90% of participants) to be easy to use and beneficial to health-related behaviours, psychosocial well-being, and outcomes. These effects, particularly on psychosocial outcomes associated with self-efficacy, mirror other past realist reviews of mechanisms of telehealth interventions for chronic disease populations.¹⁷¹ This is particularly notable given that a past meta-analysis of 65 studies has found that self-efficacy is the strongest wellness determinant of heart failure self-care behaviours¹⁷⁵ and should be addressed in interventions for chronic cardiac populations¹⁷⁶ or exercise promotion.¹⁷⁷

There was also enduring and consistent consensus across the studies that remote monitoring programs were safe. These perceptions of benefit and safety concur with objective data from recent, more general effectiveness-focused systematic reviews of trials of remote monitoring programs for cardiac rehabilitation¹⁷⁸ and heart failure,¹⁷⁹ and meta-reviews of technology-based programs for diabetes.^{179, 180} Collectively, this evidence suggests that remote monitoring programs are a useful alternative to facility-based programs for chronic cardiac conditions.

As remote monitoring programs and similar telehealth interventions remain comparatively underutilized in health care settings,¹⁷⁰ the psychosocial and convenience benefits of remote monitoring programs identified by this and other realist reviews¹⁷² should be interpreted in the context of 30 years of research, which has identified that access to facility-based disease management and rehabilitation services for cardiac patients is low, and may be most challenging for patients most in need of support, notably: women,¹⁸¹ patients with low income,¹⁸² Indigenous communities,^183,184 people living in rural settings,^185,186 or those who, because of intersectionality, experience multiple forms of marginalization.¹⁸⁷ Remote monitoring programs may be a particularly attractive alternative to facility-based programs, given that past interventions to increase usage of these facility-based services have proven ineffective,¹⁸⁸ and this review identified no strong or consistent negative effects of age, sex, ethnicity, or social status on remote monitoring program usage.

While programs were viewed as being easy to use and the most frequently reported technical glitches with programs were minor (i.e., poor connectivity and short battery life of devices), both patients and professionals indicated that to be effective, remote monitoring programs must have accessible and helpful technical support. This was a key finding of the single realist evaluation in the cohort of studies reviewed.¹¹³

Further, instead of being viewed by patients as being entirely separate care programs per se, remote monitoring programs across the conditions were viewed as extensions of, rather than replacements for, health professionals and facility-based care. As such, instead of replacing direct patient care, remote monitoring programs across chronic conditions consolidated existing patient-provider relationships and provided opportunities for more efficient and effective facility-based care consultations. This had the most significant implications for heart failure remote monitoring programs, for which care (by self, caregivers, or professionals) is notably complex, multi-faceted, and frequent.¹⁸⁹ Consequently, the heart failure remote monitoring programs were also seen to incur considerable additional technical and care work for health care providers overseeing set-up and support for the remote monitoring programs. This finding questions approaches to remote monitoring programs for chronic cardiac conditions that categorize telehealth interventions as non-relational and “cold” compared to the supposed “warmth” of face-to-face clinical consultations.^4,189 Indeed, the relational elements of remote monitoring programs is evident in existing realist reviews of trials of electronic, mobile, and telehealth tools for chronic disease in which professionals remain the dominant and more active agent in remote monitoring programs compared to patients.¹⁷¹ Future remote monitoring programs need to address how to re-balance this, improving design to better ensure that patients take a more active and frequent role in care.

Perspectives and Experiences Review

This section addresses the following research questions:

For people living with a chronic cardiac condition or post-cardiac event, what are their expectations of, experiences with, and perspectives on remote monitoring programs? What are their families’ and care providers’ expectations of, experiences with, and perspectives on remote monitoring programs?

To ensure the relevance of the analysis to this HTA, a set of secondary research questions was used to guide and focus the analysis on particular features of the use of remote monitoring programs:

How do people living with a chronic cardiac condition or post-cardiac event, their families, and their care providers experience and understand:

• how to adopt and use remote monitoring programs?

• how remote monitoring programs move health care into peoples’ places of residence and the impact of this shift on the families of people living with a chronic cardiac condition or post-cardiac event?

• the changes in roles and responsibilities that can accompany remote monitoring programs and the impact of this shift on the families of people living with a chronic cardiac condition or post-cardiac event?

• how and when remote monitoring programs are seen as working or not working?

Study Design

A qualitative evidence synthesis of primary qualitative research was conducted to understand and describe peoples’ experience with and perspectives on remote monitoring programs for chronic cardiac conditions and cardiac rehabilitation. Included publications were synthesized using thematic synthesis.¹⁹⁰ The primary goal of this review was to consider how remote monitoring plays out in the lives of those who engage with it, and its impact on their lives, their roles and social relations, and their health care.

Literature Search Methods

The search for literature exploring perspectives and experiences was performed by an information specialist using a peer-reviewed search strategy according to the PRESS Peer Review of Electronic Search Strategies checklist.⁶⁵ The complete search strategy is presented in Appendix 1.

Published literature was identified by searching the following bibliographic databases: MEDLINE All (1946‒) via Ovid, CINAHL via EBSCO, and Scopus. Duplicates were removed by manual deduplication in Endnote. The search strategy comprised both controlled vocabulary, such as the National Library of Medicine’s MeSH, and keywords. The main search concepts were chronic cardiac conditions, cardiac rehabilitation, and remote monitoring.

CADTH-developed search filters were applied to limit retrieval to qualitative studies. Retrieval was not limited by publication date but was limited to English- or French-language documents.

The initial search was completed on August 26, 2020. Regular alerts updated the search until the publication of the final report.

Grey literature (literature that is not commercially published) was identified by searching sources listed in relevant sections of the Grey Matters: A Practical Tool for Searching Health-Related Grey Literature checklist.⁶⁶ This includes the websites of regulatory agencies, HTA agencies, clinical guideline repositories, systematic review repositories, patient-related groups, and professional associations. Google was used to search for additional internet-based materials. These searches were supplemented by reviewing bibliographies of key papers and through contacts with experts and industry, as appropriate. See Appendix 1 for more information on the grey literature search strategy.

Selection Criteria

Selected publications were primary English-language qualitative studies. For the purpose of this review, qualitative studies are those that use both qualitative data collection methods (e.g., documents, interviews, or participant observation) and qualitative data analysis methods (e.g., constant comparative method, content analysis). Studies that use surveys as a method of data collection were excluded.

Studies with multiple publications using the same dataset were included if they reported on distinct research questions. Table 4 describes the selection criteria used, built using the SPIDER criteria for framing qualitative evidence synthesis research questions.⁶⁷

Publications reporting on remote monitoring programs that include people living with a chronic cardiac condition or post-cardiac event and those living with other health conditions (e.g., chronic obstructive pulmonary disease, diabetes) were included even if there was no separate reporting by cardiac conditions. Publications reporting on programs monitoring people with hypertension associated with pregnancy were excluded. Publications that were case reports, editorials, or commentaries or non–full-text publications (i.e., abstracts) were excluded.

Title and abstract screening involved 2 reviewers experienced with qualitative syntheses who assessed titles and abstracts of potentially eligible publications in DistillerSR.⁷⁰ At the first level of screening, reviewers excluded citations based on title and abstract that were assessed as being not qualitative. At the second level of screening, they assessed citations for eligibility based on whether publications were about remote monitoring and adults with chronic cardiac conditions or those eligible for rehabilitation for an acute cardiac event. The reviewers conducted duplicate full-text screening and differing judgments about publication inclusion were resolved through discussion. Appendix 2, Figure 2 documents study selection using a PRISMA flow diagram.¹⁹¹

Data Extraction

One reviewer extracted data describing study and participant characteristics for each included publication, using electronic data extraction forms. Data extraction forms were built a priori to capture key study and participant characteristics; they are reported in Appendix 2, Table 11 (and summarized narratively).

Critical Appraisal

The process of critical appraisal was conducted to support qualitative reviewers’ understandings of the rigour of the included publications and relevance to this review. The primary reviewer assessed the quality of included publications and followed Krefting’s¹⁹² interpretation of Lincoln and Guba’s¹⁹³ approach to assessing trustworthiness in quality research. The appraisal was guided by 3 primary questions intended to assess if and how a study demonstrated that it collected rich data, conducted a rigorous analysis, and incorporated reflexive practices leading to robust results that were useful for the objectives of this review: Is it credible? Is it trustworthy? Are the results transferable?¹⁹² The 10 items of the CASP Qualitative Checklist⁷¹ were used as prompts to engage with questions of credibility, trustworthiness, and transferability.

The primary reviewer conducted the appraisal. The second reviewer explored the primary reviewer’s assessment of the literature on key issues around credibility, trustworthiness and dependability, and transferability through conversation and a review of the Table of Quality Appraisal. Disagreements on the appraisal were resolved through conversation. Results of the critical appraisal were not used to exclude studies from this review, but instead to understand the methodological and conceptual limitations of the included publications in specific relation to this review. In particular, the process of critical appraisal informed the analysis in terms of the limits of what the available empirical research can tell us about peoples’ engagement with remote monitoring and the transferability of the results to the research questions and Canadian contexts.

The results of the critical appraisal were reported as a narrative summary and in the Table of Quality Appraisal, which document key issues around the credibility, trustworthiness, and transferability of each of the included studies.

Data Analysis

Descriptive Analysis

A descriptive analysis of study characteristics was conducted. The results are presented in tabular form and are accompanied by a narrative summary. The purpose of the descriptive analysis was to describe the set of included studies and understand the range of types of programs, participants, methods, and data that informed the synthesis.

Data Synthesis

The primary qualitative reviewer conducted the analysis, while the role of the second reviewer was to ensure that the concepts, findings, and their connections made sense, to probe and explore other configurations and relationships in the analysis and the data, and to ensure the review and its findings remained relevant to the decision problem this HTA seeks to address.

The analysis followed the principles of thematic synthesis, which draws on meta-ethnography and grounded theory.^190,194 It involves 3 stages of formal coding procedures: (1) open coding, (2) descriptive coding, and (3) the development of analytic findings.¹⁹⁰ These inductive coding practices draw heavily from grounded theory, and use the constant comparison method in which codes and data are compared across codes and within and across publications. From meta-ethnography, thematic synthesis borrows the concept of reciprocal translation where, in the first and second stage of coding, the process of coding and sorting “like with like” works to translate findings across studies.

Open and descriptive coding was conducted by the primary reviewer by reading and re-reading included studies and making marginal notes and memos (on the full-text PDFs and in Word) to capture initial observations, reflections, and disconnections and/or connections within the individual study and the set of included studies. The reviewer coded the data by highlighting and bracketing lines or sections that were annotated. Marginal notes were at first largely descriptive of the findings and referred directly to a single line or paragraph, but also included analytic notes that were an evaluation of or reflection on the findings or methods. Similar to the inductive logic of line-by-line and descriptive coding, this process allowed the reviewer to begin making connections across and within the data presented by the set of included studies.

The reviewer mapped emergent concepts as they related to the primary and secondary research questions using concept mapping techniques of diagramming. Preliminary and evolving analyses were brought to the second review and lead authors of other sections of this HTA for discussion and reflection, to identify potential overlaps in findings across the HTA, to continue to ensure that the analysis was responding to the scope and questions of this section and the HTA, and to foster reflexive practices among the team.

Based on these discussions, a refined concept map of key findings and their connections was developed that served as the basis of the analytic synthesis. Analytic synthesis is the development of constructs and categories that are interpretations of the data and descriptive findings. To develop analytic themes, further memoing and diagramming was used to assemble and sort the previously established descriptive findings, going back to the data to further develop the relationship between themes and codes, in keeping with the iterative nature of qualitative analysis. The purpose of this third stage of coding is interpretation — a new synthesis or interpretation of the existing published data in relation to the research question. Analytical synthesis stopped once findings and their relationships were well described, and no additional descriptive or interpretive insights arose from further analysis or coding of the included studies.

Reflexivity

Reflexivity is an epistemological principle and methodological approach in qualitative research that recognizes the role of the researcher as instrument. Reflexive practices and techniques are those that allow for and facilitate making researchers’ observations and interpretations transparent and explicit versus implicit and unacknowledged. This study employed the reflexive practices of memoing and frequent dialogue between the 2 qualitative reviewers and other members of the HTA team to probe and position reviewers in relation to the analysis. Further, the qualitative reviewers explored possible alternative interpretations of the findings to triangulate them with additional empirical sources (e.g., published qualitative reviews) and patient engagement activities to identify possible alternate concepts, connections, and interpretations.

Results

Quantity of Research Available

A total of 978 citations were identified in the literature search. Following screening of titles and abstracts, 924 citations were excluded and 54 potentially eligible reports from the electronic search were retrieved for full-text review. Of these, 24 publications did not meet the eligibility criteria and were excluded. A total of 27 studies, reported in 30 publications, met the inclusion criteria and were included in this report. Additional details are reported in Figure 2 (Appendix 2).

Descriptive Analysis

Additional details regarding the characteristics of the included publications and their participants are provided in Appendix 2, Table 11.

Methods of Data Collection and Analysis

Of the 30 included publications, 1 each was described as using community-based action research,¹⁴¹ multi-level qualitive study design,¹⁹⁵ interpretive phenomenological analysis,¹³⁰ descriptive qualitative with a phenomenographic approach,¹³³ phenomenological-hermeneutic approach,⁹⁰ and qualitative explorative approach.¹⁹⁶ Two publications each were reported as using a qualitative descriptive design and^197,198 grounded theory,^199,200 and 2 publications from the same study used qualitative process design.^201,202 The remaining 18 publications did not report the study design used.^{83,85,101,106,112,123,203-214}

Semi-structured interviews were used as the primary method of data collection by 20 of the included publications.^{83,85,90,101,106,112,123,133,197,198,200-203,205-207,210,211,214} Five used both focus groups and interviews,^{130,204,208,209,213} and 3 publications used focus groups alone to collect data.^141,199,212 One publication used audio- or video-recorded consultations between providers and patients¹⁹⁶ and another used observations, documents, and interviews.¹⁹⁵

Thematic analysis was used in 10of the included publications.^{83,85,197,198,201,204,210-213} Three publications reported using content analysis.^123,205,209 Three publications each reported using grounded theory.^199,200,208 Two publications each reported using constant comparison,^101,214 a phenomenological approach,^90,133 a framework approach,^106,207 and deductive analysis.^112,203 One publication each reported using grounded theory and thematic analysis,¹⁹⁵ thematic analysis and constant comparison,²⁰² category analysis,²⁰⁶ interpretive phenomenological analysis,¹³⁰ and interaction analysis.¹⁹⁶ One study did not report the method of data analysis used.¹⁴¹

Location of Study

Fourteen publications reported studies conducted in the UK.^{83,85,101,106,130,198,201,202,204,206-208,212,214} Six publications reported studies conducted in Sweden,^{112,133,196,200,205,211} 4 in Canada,^{123,195,197,210} and 3 each in the US.^141,203,209 One publication each reported on a study conducted in Malaysia,²¹³ Finland,¹⁹⁹ and Denmark.⁹⁰

Description of Remote Monitoring Programs

Ten of the publications reported on remote monitoring programs for heart failure,^{101,106,112,123,133,141,203,205,206,209} and 6 publications reported on programs that included heart failure and other chronic conditions (e.g., chronic obstructive pulmonary disease, diabetes).^{130,195,200,204,207,208} These programs tended to measure weight, blood pressure, and pulse, and administered daily symptom questionnaires and transmitted data to a health care provider such as a telehealth nurse for monitoring, with the objective of preventing exacerbations of participants’ condition and hospitalizations.

Five publications reported on remote cardiac rehabilitation programs.^{83,85,90,197,199} These programs tended to include physical activity and health promotion education sessions virtually and collected self-reported data on diet and activity levels, to help promote a return to healthy activity and heart-health lifestyle choices.

Nine publications reported on remote monitoring programs for hypertension.^{196,198,201,202,210-214} These programs tended to be delivered by primary care providers or clinics and were used to adjust medications to address participants’ uncontrolled hypertension.

Description of Participants

For the purposes of narrative summary, participant descriptions were sorted into 4 categories: adults living with a chronic cardiac condition or eligible for cardiac rehabilitation; family members or informal carers for people living with a chronic cardiac condition or post-cardiac event; health care providers (e.g., nurses, general practitioners, cardiologists, health assistants) and decision-makers (e.g., hospital or health system managers); and public and patient stakeholders (e.g., patient engagement, public involvement, or advisory committee members).

Seventeen publications included people living with cardiac conditions or who were eligible for cardiac rehabilitation.^{83,85,90,101,112,133,197,199-203,209-211,213,214} Five publications included adults living with cardiac conditions and health care providers.^{106,123,196,198,204} One publication each included public and patient stakeholders and adults living with cardiac conditions¹⁴¹ and 2 publications included adults living with cardiac conditions and their spouses or informal carers.^205,208

Three publications included health care providers,^130,206,212 1 publication included adults living with cardiac conditions, health care providers, and decision-makers,¹⁹⁵ and 1 included health care providers and stakeholders.²⁰⁷

Summary of Critical Appraisal

Overall, the studies were assessed to be moderately trustworthy. Additional details about the results of the critical appraisal can be found in Table 12 (Appendix 2).

Credibility was affected primarily by data collection and analysis strategies that included a priori assumptions, leading interview questions, limited ability to collect rich data, and raised questions about the coherence or adequacy of the description of findings. The majority of studies with the research objective of exploring experience and perspectives of people engaging with remote monitoring tended to operationalize this as a focus on barriers or facilitators to, and the acceptability of, remote monitoring programs. This narrowing of experiences and perspectives through lines of questioning tended to result in analyses that were superficial in their probing around the breadth of people’s experiences of remote monitoring. A few studies included participants who opted not to participate, which increased their credibility.

The dependability of the findings of the included studies was often undermined by the lack of reporting around the relationship of the authors to participants and no discussion of reflexive practices or the role of the research team. This led the reviewers to judge in these cases that the raw data presented were trustworthy, but not the findings per se.

Given the heterogeneity in remote monitoring interventions and this review’s orientation toward programs more broadly, the assessment of transferability focused less on issues of generalizability from intervention types and context and more on the objectives of the review. Transferability was sometimes lessened by the limited focus of many of the included studies on the acceptability of remote monitoring interventions. While these provided information on peoples’ views on whether they would accept, adopt, and/or use remote monitoring, they were not relevant to perspectives and experiences more broadly.

A final issue affecting the trustworthiness of the set of included studies was that most of the included studies recruited people who either started or completed a remote monitoring program as part of a trial or pilot study. Important differences between people who participated in the qualitative studies of remote monitoring studies (versus programs) raised concerns about representativeness of the findings across people with chronic cardiac conditions.

Data Synthesis

Adopting, Using, and Participating in Remote Monitoring and Cardiac Rehabilitation: The Perspectives of People Living With Cardiac Conditions

Peoples’ Perception of Their Technological Literacy Shaped Their Willingness to Adopt and Use Remote Monitoring and Cardiac Rehabilitation

Individuals’ views of their own low technological literacy and limited experiences using mobile phones, the internet, and computer technologies arose as a common response as to why they chose to not engage with remote monitoring programs or cardiac rehabilitation.^{85,197,199,203,205,208,213} This finding raises the possibility that those with high technological literacy would be more likely to adopt and use remote monitoring technologies, yet this was only limitedly described by participants adopting remote monitoring.²⁰³ It is possible that high levels of technological literacy may not act as a facilitator in the same way that low levels of technological literacy are evoked as a barrier to remote monitoring programs.

Where technological literacy was described by participants living with chronic conditions as a barrier to engaging with or successfully adopting remote monitoring, they often attributed it to their advanced age or being from another generation.^{85,197,199,203,205,208,213} Participants voiced these attitudes in ways such as: “[t]he thing is, you know, our age group, all of this is new technology and we haven’t done anything, and not the newer generation, they are going to be on it like a dirty shirt” (p. 10).¹⁹⁷ This points to the way that assumptions around age and technological literacy are connected to peoples’ views of the desirability of engaging with remote monitoring programs.

Some seniors expressed that, beyond not knowing how, it was that they did not want to use mobile phones, the internet, or computers.^199,205,208 However, in some cases, they saw non-computer devices such as a digital pen or health diary as acceptable.²⁰⁵ This suggests that differences in the technologies used in remote monitoring programs can accommodate a range of technological literacy and abilities.

Problems With the Technologies Discouraged People From Adopting and Using Remote Monitoring, Although Informal Caregivers Sometimes Helped to Overcome Them

When encountered, problems with the monitoring equipment were described by people as deterring them from continuing to participate in monitoring.^133,197,208

Participants articulated being fatigued and frustrated when the way their remote monitoring equipment worked was not as consistent as expected.^133,197 When equipment provided unreliable readings, inaccurate readings, or false alarms, participants found monitoring disruptive and stressful.^85,208 Sometimes, technical challenges were a function of the monitoring equipment itself; for example, using displays with a small font that made it challenging for those with limited sight or small controls that were difficult for people with motor control symptoms, such as those with Parkinson disease.^141,195 These challenges became even more insurmountable where language barriers were not accounted for.^195,208

This led some to withdraw from monitoring programs or not participate.^133,208 For others, the ability to call on informal caregivers, particularly adult children, to troubleshoot equipment problems helped them overcome technological challenges and continue participating in remote monitoring.^{85,101,112,133,195,197}

Installing Equipment Required Finding the Space and Having the Necessary Connections, Which Was Not Always Easy or Possible

Depending on the type of connection required and the size of the equipment, people described finding a location for the equipment as being challenging, particularly when the equipment required a location with both a phone jack and electrical outlet.^{85,106,141,209}

Large and bulky equipment was difficult to place in their homes, due to space limitations.^106,203,209 For some participants, the equipment ended up being in a bedroom, which was not their preference.²⁰⁹ This deterred people at times from participating, as 1 participant with heart failure articulated:

[The equipment] wasn’t working at all… And the next thing you know he [equipment support staff] comes in and he says, “you can’t do without the…phone line,” and so I said to him, “It is somewhat of an aggravation, you must take it back”… I couldn’t, you know, have too many wires here and all this, you know. I said to myself, “why should I have it?” (p. 6).²⁰⁸

Although not widespread, some people with chronic cardiac conditions did report incurring out-of-pocket costs for participating in remote monitoring programs; for example, for broadband cable installation.¹⁰⁶ These costs may be more substantial than reported given that many of the included studies were trials or pilots versus routinely delivered programs.

People to Learn How to Make Taking Measurements a Routine, Which Was Particularly Challenging for Those With Busy, Active Lives or Who Travelled

A crucial first step in adopting and using remote monitoring was finding ways to make the taking of measurements routine.^{101,112,133,202,209,213} People described being fearful of forgetting and found it challenging to remember to take daily measurements using the equipment.^133,202,209 Many described that it took effort to do so, and time to develop their own strategies (e.g., taking measurements upon first waking) for making it a habit. Family members, particularly cohabitating partners, could help them remember.¹¹²

For those who were able to do so, travelling presented a particular challenge, with having to both bring along the equipment and keep their routines.^112,213 Those using mobile phone-based monitoring systems reported enjoying the portability of it as they could continue to travel.¹²³ People described that having to work full-time or being busy in the evenings made it difficult.^202,213 It was unclear whether this was because of the logistics of taking measurements and/or time constraints per se, or if it was that the effort of remote monitoring had to be balanced out with other priorities. People balanced the challenges of making it routine with their perceptions of how the intervention would benefit them,²⁰² suggesting that peoples’ ability and willingness to invest in the energy to make a routine involves multiple considerations, including, but not limited to, logistics. For some, they found it a role that they did not want to take on as it was too time consuming; as 1 participant expressed, they “did not want to be a nurse.”²⁰⁸

Engaging With Remote Monitoring Could Challenge One’s Identity and Sense of Self

For some, rather than fostering independence (one of the purported goals of remote monitoring), remote monitoring was experienced as increasing dependency for those who needed help to complete daily measurements because they were too ill.²⁰⁸

Respondents identified it as being for the sick or for those who had no one at home.^203,208 The idea of being watched was interpreted as being a form of dependence, and as undermining their sense of independence in their own form of self-management.²⁰⁸ It was seen as relegating them to their home, as keeping them indoors versus out and about. and as interfering with other values and priorities in life.²⁰⁸ Where participants did not identify as being someone who they thought programs were for, they decided that remote monitoring was not for them.^203,208

Remote Monitoring Programs and Understandings and Experiences of Self-Management

The Benefit of Self-Management Was Often Framed by People Living With Chronic Cardiac Conditions as a Process of Becoming Aware, Making Connections, and Feeling Responsible for Their Health

Remote monitoring programs involved people measuring and recording their bodies and symptoms. Participants living with chronic cardiac conditions described how the act of remote monitoring and taking measurements drew their attention toward their bodies both as measured and experienced (observed and felt).^101,123,205 For some, this attention to their bodies and its changes was a source of anxiety and stress, particularly for those who thought high readings were indicative of an underlying serious health issue.^{112,123,133,202} As 1 participant with heart failure described, “I am a little frightened to step up on the scale. If I have gone up [in weight,] it will be fluid in the body and that can change rapidly” (p. 4).¹³³ These worries are tied with how the act of measurement could contrast with peoples’ perceptions of their health and their bodies.

Listening to the body through the act of measurement was seen by participants as enabling them to make connections between their behaviours and lifestyle (e.g., diet, exercise, medications, stress) and their measurements or observations.^{112,123,198,200,202,204,211} One participant described how they saw it: “If you eat something that is very salty, for example, you go straight up… The next day you see that you have put on more weight, because it’s liquid that you store” (p. 451).¹¹² Some described that living with the constant surveillance of remote monitoring was difficult.¹²³ Remote monitoring challenged them as the need to measure and monitor their behaviour left them bounded, and they wanted “to enjoy life once in a while.”¹²³

Acquiring insight into and about the connections between one’s behaviours and one’s measurements and body was a process that took time: time to make observations, for patterns to emerge, and to learn.^{101,112,204,209} Self-management, as a process, was about gaining understanding and control over these connections, bounded by the relationship and interactions between participants and their equipment. It was through interacting with remote monitoring over time that people learned the connections between their measurements, bodies, and behaviour.

Responsibility, in this way, was individualized: “It [remote monitoring program] taught you how to take care of yourself and do it on your own, because nobody else is gonna do it for you” (p. 220).²⁰⁹ As a form of self-management, it meant taking responsibility for and coping with or managing ones’ symptoms independently.^{112,133,209,211} Take, for instance, the following explanation relayed by someone living with heart failure about coping with breathlessness:

If I do feel ill, I can go on that and I can look at my own readings, rather than to start what you would call — having what you would call — going into a panic mode where your breathing would get, um, very difficult and you would, you start to panic, so then you would be ringing an ambulance, and now I can go on the machine and I can look at the readings and say, well, this is OK, this isn’t that bad, I don’t need to phone an ambulance, I just need to calm myself down (p. 314).²⁰⁴

These benefits were not seen or expressed by those whose measurements²¹³ or health conditions were stable,^200,214 or who had already been collecting and monitoring their own measurements,^133,203 or who could not see a change in their health,²⁰⁵ even with lifestyle changes or medication changes.²⁰² For some, it became a bother — repetitious, monotonous, boring: “It was just kind of the same old thing everyday, and I just got kind of bored with it I guess” (p. 221).²⁰⁹

Taking Responsibility for Self-Management of Medication Was Seen by People Living With Chronic Cardiac Conditions as Requiring More Guidance From Health Care Providers to Learn and Become Confident in Changing Doses or Medications

Overall, people described an openness to taking greater responsibility for their cardiac condition through remote monitoring; however, some participants expressed reservations about the demands that self-management of medication put on them.^{106,202,213,214} Some were happy to take instructions, but would not self-administer diuretics upon a weight increase.¹⁰¹ Some did not take the advice either, instead deferring to their own sense of their body or condition: “It’s difficult with the weight because sometimes I’ve had people phoning up and saying: ‘take an extra diuretic’ ...but I always go by the fact that I can see my veins and everything here and when I was ill I couldn’t because of the fluid” (p. 2450).¹⁰¹ Others described that they felt it was their doctor’s role²¹⁴ or worried about potential side effects or contraindications, which led them to want to speak to their doctor before changing their medications.²⁰¹ When they took an out-of-range reading but did not get input from their health care provider, or they lacked certainty in what course of action to take, they were reticent to make any medication changes.^202,213

Others thought that they were following medication plans rather than adjusting their medication. Framing it this way continued to place a responsibility on the physician for prescribing, and they were just following the doctor’s advice: “I mean, it isn’t as though I’m taking an initiative in deciding what to take and what extra to take. It’s only… it’s still basically up to the doctor, isn’t it…” (p. 4).²¹⁴ It was a matter of learning and gaining confidence through remote monitoring that led them to adjust their medications:

[T]he doctors kept saying to me that you can self-medicate with fluid tablets. And I would think “oh no [laugh], I don’t know what I’m doing here, so I’m not going to do that…” But then the [telemonitoring staff] at the other end said take another fluid tablet… And then gradually, I started to realise that when I felt unwell I was able to think “oh, you know, take another tablet or half a tablet” (p. 137).¹⁰⁶

Remote Monitoring Was Seen as an External Motivation for Self-Management Requiring Accountability and Providing Reminders: Once Discontinued, People Struggled to Continue Implementing Lifestyle Changes

There was a strongly expressed view held by participants that remote monitoring supported them to self-manage by being an external motivation.^{83,85,133,205,209} This manifested through people using remote monitoring, and appreciating the reminders and the need to submit a record of their activity (whether diet or exercise): “It motivates you to think ohh I’ve got to get up and do 30 minutes exercise today. Because I’ve got to go up and fill the diary in. It’s motivating” (p. 437).⁸³

As a source of reminders and requiring accountability, remote monitoring was seen as sustaining motivation for self-management: “You know I had stents four years ago, and you start off with the best of intentions, but nobody looks over your shoulder and you peter out. At this time, I felt this is a nifty program… somebody’s watching it and I better do it. Keeps you honest, keeps you focused” (p. 9).¹⁹⁷ Here, being watched meant providing a sense of having to be accountable for one’s choices and behaviours.

In this light, it is not surprising that people shared that the patterns and habits built during remote monitoring programs of fixed duration were difficult to continue afterwards. Many expressed their desire or intention to purchase their own home monitoring equipment or their desire that the program would be extended.^{101,133,141,197,205,209}

Expectations and Experiences of Remote Monitoring as More Than Self-Management

Remote Monitoring as Providing a Sense of Security by Being Watched and Cared For

A common thread among accounts of people who used remote monitoring was a feeling of security in that they were being watched.^{106,112,123,133,197,200,202,203,205,211} Expressions of this sense of security were most prominent among those with heart failure, likely a result of the nature of the condition (its variability and the panic associated with breathlessness) and program objectives (preventing exacerbations and keeping patients stable). Being watched meant that, as 1 participant with chronic heart failure described it, “I know if there’s something wrong, they are going to pick it up right away… if something goes wrong, they’ll phone me. [It’s a] safety net” (p. 137).¹⁰⁶ The feeling of security experienced by people and their informal caregivers was described as being particularly present for those who did not have ready access to a primary care provider.²⁰⁷ On the other hand, those who felt they were already watched by caregivers chose not to participate.²⁰³ Those with heart failure described that they needed to be able to access health care services for unscheduled health care needs, drawing on their past experiences of seeking care for their symptoms.¹⁰¹

With this perception of being watched came a feeling of reassurance that one was being cared for.^106,123,133 Care was felt as a form of concern and attention from health care providers that was embedded in remote monitoring: “[i]t gives the sort of reassurance that Big Brother’s watching me and even perhaps they can look after me” (p. 136).¹⁰⁶

Remote monitoring was described by providers as enabling them to be able to care for patients more frequently and watch them more closely:^106,211,212 “It allows us to look at patients every single day, as opposed to, at the moment, seeing people, maybe every four, six, or twelve weeks, depending on the patient, so you get a much better picture of their daily condition… things get picked up a lot quicker” (p. 136).¹⁰⁶ However, some providers (nurses) expressed worries about social isolation being reinforced or not identified:

[I]f you get them to the clinic or a group session or we were visiting, we could identify social isolation. And perhaps day centres, things like that. So it can mask I think social isolation. This patient was crying out that I just wanted the human touch back... Just talking about things to someone and not to a box makes (sic) difference... because it’s (telehealth equipment) not a person, is it? (p. 5).¹³⁰

This remark draws out how providers, when caring for their cardiac patients, attend to other social factors that relate to their patient’s heart condition that may not be able to be observed in the context of remote monitoring.

Remote Monitoring as Facilitating Access to Health Care and Fostering Closer Connections Between Patients and Providers

People who use remote monitoring described valuing it for the ways it provided them access to health care.^{195,197,200,208} This was both the convenience of being able to access health care without travel,^{123,195,197,208} and the ability to connect with their health care provider when they felt they needed it. As 1 participant described it, “When one was discharged from the hospital there never used to be real follow-up… You felt like you were being dropped off a cliff…[Telehomecare] provided a sense of security, because you were in contact with someone who could help you, versus having to make an appointment with your family physician, and get there, and back” (p. 8).¹⁹⁵

Remote monitoring was described by participants as enabling them to have closer contact with those health care providers with whom they had pre-established relationships.^{123,133,205,211} As mentioned previously, it also facilitated access for some participants to health care providers, particularly for those who did not have a primary care provider.²⁰⁷ In some cases, people living with a chronic condition built new relationships with telehealth nurses, which they appreciated.^101,195 Seeing remote monitoring as facilitating access to health care was also expressed by health care providers.¹⁹⁵

Peoples’ sense of satisfaction with their existing health care services affected their desire to engage with remote monitoring programs.^203,208 Those who described already having access to care when they sought it and who privileged their face-to-face and established relationships with providers did not see remote monitoring as offering them anything of value and chose to not participate.²⁰⁸ For those who had experienced instability in their care, such as transitioning between specialists or settings, they viewed being offered remote monitoring as further interrupting and destabilizing their care.²⁰⁸ Those who felt they did not need access to additional care (i.e., their condition was stable and they felt they had the tools and skills to manage at home) did not express interest in using remote monitoring for their heart condition.²⁰³

This suggests that expectations around remote monitoring programs are intimately intertwined with what one expects of health care services more generally, and how one negotiates care seeking. These views on remote monitoring as a way of accessing health care draw attention to how programs are seen and experienced by participants as part and parcel of health care as opposed to a supplemental program or technology.

Remote Monitoring as a Model of Care

Providers and patients alike appreciated the ways that remote monitoring programs fostered people living with cardiac conditions to be more involved in their care by, for example, having focused questions about medications and symptoms and readings for their consultations.^{101,196,197,201,211,215} In this light, remote monitoring is part of facilitating the provision of treatment and care of chronic heart conditions during scheduled visits and routine care as opposed to a stand-alone intervention. Ambiguity about whether remote monitoring was a new technology or clinical tool, or a new model of delivering care, was described as a barrier for adoption by providers because of the uncertainty it evoked.²⁰⁷

People living with chronic cardiac conditions saw remote monitoring as saving their general practitioners’ time, recognizing the pressures facing health care:²⁰¹ “You can go in loaded with evidence, ‘I’ve been doing this’ and ‘I’m on the BP study’ and if they’re aware of it they’ll go ‘ah, better listen to this bloke.’ I’ve collated, then it’s going to save the doctor time and save me a lot of trouble as well. And improve me, which is important” (p. 10).²⁰¹

Providers’ experiences and expectations with remote monitoring embodied views of remote monitoring as both taking time and reducing time.²¹² Taking time related to concerns around the increased time due to increased consultations,^201,212 the time required to look at submitted data in preparation for consultations,²¹¹ and the consultations themselves taking more time.²¹¹ On the other hand, they were described as saving time,^211,212 particularly in the long term, due to the increased efficiency they afford (being able to capture health concerns early and once patients were successfully self-managing). Remote monitoring programs were seen by providers as being a good use of time, even if it took more time: “[s]o it may increase workload, but in a good way, because it might mean that we visit them earlier and, but we are, you know, we are in the business of preventing admissions to hospital. So the workload is a correct way of our time, it’s the correct use, that’s fine, absolutely fine” (p. 5).¹³⁰

Gains were also thought to be made as providers expressed that remote monitoring offered an opportunity to see more patients:^207,212 “We are being asked to see more patients with no additional resources…How can we release a little bit of our capacity? Because our capacity is at absolute maximum all the time… I think telehealth helps from that point of view” (p. 331).²⁰⁷ However, those delivering remote monitoring programs described that expectations about volume needed to be tempered: “They say when you do health coaching your phone call should only last 7 min in order to maintain a caseload of 60 people… Well… it’s just not feasible when you’ve got some of the clientele we have” (p. 9).¹⁹⁵ Many providers relayed experiences and concerns around an increase in workload in their descriptions of delivering remote monitoring programs.^{123,130,195,198,206,212} This increase in workload was attributed to a number of factors, including the increased number of patient contacts from those who were being monitored remotely;^{130,195,198,212} the need for rapid decision-making and responding to alerts, which interrupted work flow;^123,198 and increased administrative duties on top of increased length of time and number of patient contacts.¹⁹⁵

Additionally, remote monitoring programs were described by providers as changing the way they worked¹⁹⁶ and how they consulted (increased use of telephone, non–face-to-face methods).¹⁹⁸ As 1 provider commented, “It’s an organizational shift that we’re going to need to make at some stage soon anyway. I’ve been doing it [emails to help patients self-manage] for a number of years but we haven’t had a proper system set up… It’s undoubtedly much more time efficient”(p. 8).²¹² This highlights the general view that remote monitoring holds positive benefits, but those need to be implemented and integrated into the system for benefits to be realized.

Lack of integration in health care (organizationally and technically) of remote monitoring presented challenges for providers.^130,206,211 Specifically, the lack of interoperability between remote monitoring systems and electronic health records increased workload for clinicians who had to enter data twice and worried about the ability to provide effective care when data were not accessible or available to the attending clinician.^{106,123,198,206,207,211}

Condition-Specific Findings

People Enrolled in Cardiac Rehabilitation Programs Had Overlapping but Different Experiences Than Those Engaged in Remote Monitoring for Chronic Cardiac Conditions

While findings relating to technological literacy and the process of learning and adopting self-management skills and behaviours were shared across remote monitoring and cardiac rehabilitation programs, some findings were unique to remote cardiac rehabilitation.

Participants of remote cardiac rehabilitation programs appreciated the accessibility and convenience of being able to participate at home and not having to travel, particularly those living in rural or small urban areas without cardiac rehabilitation centres.¹⁹⁷ The ability to do the program individually as opposed to as a group⁹⁰ and on their own time was welcomed by many.^85,90,197

Likely as a function of the patient population eligible for cardiac rehabilitation, issues with scheduling and finding time to balance participating (particularly exercising) with employment and family responsibilities were described by participants.^83,85,90 Weather could also affect participants’ ability to engage in physical activity.^83,85 “It was the wrong time of the year I mean if it had been another 6 weeks from now, it was all that awful weather so I was trying to walk around in the ice and snow and goodness know what, and it was cold” (p. 438).⁸³ This is relevant for Canadian contexts.

The programs were at times asking for a large-scale shift in participants’ lifestyle (e.g., starting a new routine of physical activity, changes in types of foods eaten), which some experienced as a challenge.^83,85,90 Some described that the expectations, particularly those relating to the exercise programs, were too high,^83,85 or that their advanced age or other health conditions made it difficult for them to complete the activities.^83,85 A mismatch between how people saw themselves and their lifestyle before an acute cardiac event and the expectations and lifestyle changes demanded by rehabilitation were described as affecting participants’ motivation for lifestyle change.^83,90 Participants who frequently engaged in physical activity before remote rehabilitation were often motivated to meet the demands of the program. Participants who felt their level of physical activity was appropriately conducive to a healthy life sometimes but were asked to increase it experienced the increased demands as too great.⁹⁰ Part of this was how people considered the investment of participating in cardiac rehabilitation in the context of their full life, that is, the ways they are willing to prioritize future health above other facets of their life.²⁰⁸ It also points to the ways that remote monitoring programs, as externally imposed expectations about one’s health and behaviour. can be in conflict with one’s own internal perception of their health and behaviour.

Variations in the Measurement of Blood Pressure Motivated and Complicated Remote Monitoring for Hypertension

More than other forms of monitoring, it took time for people using remote monitoring for hypertension to learn and be confident in taking blood pressure measurements.^210,214 People with high blood pressure expressed worries around whether they were measuring their blood pressure correctly,^201,210,214 or if readings were representative given they fluctuated throughout the day,^{201, 202} and could be lower at home than at the clinic.^202,213,214 At the same time, taking blood pressure readings at home felt more accurate to participants because it was a more relaxed environment than at the clinic.^198,214 Variation in views on and comfort with taking blood pressure readings was described as being influenced by peoples’ understandings of their blood pressure^210,214 and length of time engaging with remote monitoring intervention.²¹⁴

Health care providers worried about making their patients who lived with hypertension anxious or obsessed with measuring blood pressure, with the view that they could become immobilized due to worries when readings are high.^{198,211,212,214}

These findings point to the ways that for hypertension, the experience of taking measurements at home may run against expectations of doing so. This suggests that there is a role for time to learn and acclimatize to the act of taking measurements that ought to be accounted for in the design of remote monitoring programs.

Summary of Results

Peoples’ perception of their technological literacy shaped their willingness to adopt and use remote monitoring and cardiac rehabilitation. Ideas around age and technological literacy were commonly invoked by people living with cardiac conditions as a reason for being disinterested or unable to participate in remote monitoring programs. When people encountered technological challenges, they expressed being discouraged from adopting and using remote monitoring. Having informal caregivers, particularly adult children, who could help troubleshoot the technologies helped them overcome these hurdles. Sometimes, the challenges were not with the use of the technologies but with the physical installation of the equipment itself, which meant finding the space and having the necessary connections. This was not always easy or possible, depending on peoples’ housing arrangements. These findings point to opportunities to develop programs that account for and anticipate potential challenges and provide the needed level of support and technological options that facilitate engagement with remote monitoring technologies.

Time was important in people’s experiences of the benefits of increasing self-management of their cardiac conditions through remote monitoring programs. It took time, and creative strategies, for people to learn how to weave measurement-taking into their daily lives, particularly for those who lived busy, active lives or who travelled. People living with cardiac conditions pointed to how they made connections between monitoring their condition and their behaviours related to diet, exercise and activity levels, and medication-taking, and this learning was a process of reflection and life experience that occurred over time. Self-management of medication was experienced by people with cardiac conditions as a process as well, requiring more guidance and support from health care providers to learn and become confident in changing doses or medications. Taken together, these findings point to the importance of considering the length of time or duration of remote monitoring programs to enable people to integrate measuring into their lives and to learn how to self-manage and take responsibility for their cardiac conditions from the process. The information provided by the included studies did not allow for detailed consideration of how systemic or structural inequalities affected how people living with chronic conditions engaged with remote monitoring — for example, by gender, for racialized people, or people living under conditions of poverty. One of the objectives of many remote monitoring programs is to facilitate people to self-manage their cardiac conditions, so this omission becomes of particular importance. For instance, self-management and behavioural changes necessitate access to resources (individual, community and societal) to support making choices that prioritized health. Findings around the lack of space may point to the ways that people, particularly seniors and those who are unable to work or are on a fixed income, may experience inadequate or precarious housing. The omission of the lenses of the social determinants of health means that the accounts provided here are unlikely to speak to the breadth of challenges people face when responsibility is individualized.

An openness to taking greater responsibility for their own health in the form of self-management was articulated by many. This was contrasted by accounts that remote monitoring was needed as an external motivation for their self-management, as it required them to be accountable and provided them with reminders. Once they discontinued remote monitoring programs, people described struggling with or giving up on monitoring their condition and implementing lifestyle changes. This draws into question the role of various mechanisms by which people find remote monitoring supports their self-management; that is, whether the process of learning and making connections and changing behaviour can happen in the absence of external mechanisms of accountability and reminders.

There are multiple expectations of remote programs in terms of what it provides individuals living with chronic cardiac conditions, the people providing care for them, and the health care systems in which they are situated. For many people using it (providers and patients), it is not just a technology that facilitates self-management. People expected and valued remote monitoring programs as a means of providing security through being watched, particularly for those with heart failure, and a way of accessing health care and fostering a closer connection between providers and patients. These point to the ways in which remote monitoring was not an addendum to care but a model of caring for patients with chronic cardiac conditions. As a model or an approach to care, this means the benefits of using remote monitoring are integral to its sustained use and it being integrated into peoples’ routine care.

While this review aimed to provide information on remote monitoring programs from the perspectives of family members and informal carers, few studies provided information from their perspective. The absence of information means that how family and informal carers experience remote monitoring, particularly the accompanied shift in responsibility to self-management, leaves unanswered questions around how it might require them to engage further in the care of their family members enrolled in remote monitoring. Similarly, whether remote monitoring programs lessen the burden of travelling to in-person medical appointments with family members remains unexplored. Additionally, while this review paid attention to differences between conditions, limitations in the reporting of the health condition of participants, particularly disease severity, left unanswered questions about how disease severity affects people’s expectations and experiences of remote monitoring.

Ethics Review

Background

The purpose of this analysis is to identify and reflect upon key ethical issues that should be considered when contemplating remote monitoring programs. The audience for this analysis is the decision-makers considering implementation or expansion of remote monitoring programs. Occasionally, questions are noted that cannot be answered in the current analysis because the HTA report lacks the fine-grained contextual information of the specific program, target population, and so forth. These guiding questions are intended to support decision-makers in their unique jurisdictions. Although other sections of this report broadly touch upon ethical dimensions, the aim of this analysis is to make such issues explicit and to identify additional ones that may be relevant to decisions in this context.

There are 2 central questions to consider when analyzing remote monitoring programs for managing chronic heart failure, atrial fibrillation, hypertension, and cardiac rehabilitation for acute and chronic conditions from an ethics lens:

1. What are the ethical issues related to the implementation of remote monitoring programs?

2. How might these issues be addressed in rural, remote, and urban settings?

Inquiry

The scope of remote monitoring programs is quite broad. The ethics analysis in this HTA report is directed toward decision-makers considering questions at the level of implementing remote monitoring programs, rather than toward individual clinicians facing the question of whether to prescribe a given remote monitoring technology at an individual patient level.

Notably, and somewhat uniquely in the HTA context, this HTA report does not include a review of clinical or economic evidence. Ethics as a domain of HTA often asks the following as foundational questions: What effect is a technology aiming to achieve, who benefits from it, and is that a worthwhile use of resources compared to other possible options? Therefore, consideration of clinical benefits will still form an important focus of this Ethics Review section, although in more general terms than a typical HTA.

Based on a review of the available literature, the following major themes were identified (drawn from the ethical analysis domain of the European Network for Health Technology Assessment [EUnetHTA] HTA Core Model)²¹⁶ and are examined as follows.

1. Guiding Values

   1. How is value and the corresponding success of remote monitoring programs defined?

   2. What is important, what is valued, and by whom?

   3. Are there value tensions?

2. Balance of Benefits and Harms

   1. What are the known and estimated benefits and harms for patients when implementing or not implementing the technology?

   2. What are the benefits and harms of remote monitoring programs for patients, informal caregivers, professionals, and organizations?

   3. Are there any absences of evidence that are ethically consequential?

3. Justice and Equity

   1. Are there factors that could prevent a group or person from gaining access to remote monitoring programs?

   2. How does the implementation of remote monitoring programs affect the distribution of health care resources?

4. Patient Autonomy

   1. Does the implementation or use of remote monitoring programs limit or affect patients’ capacities or possibilities to exercise their autonomy?

5. Professional Autonomy

   1. How do remote monitoring programs limit or affect clinicians’ capacities to exercise their autonomy as professionals?

6. Privacy and Confidentiality

   1. What risks do remote monitoring programs pose for patients’ privacy and confidentiality?

Data Collection: Review of Empirical and Normative Bioethics Literature

The literature review identified both explicit and implicit ethics content for the specific conditions in relation to remote monitoring programs. It also identified some ethical analyses of telehealth technologies in general, and the nature of patients’ relationships with these and their health care providers.

Literature Search Methods

The search for literature identifying explicit ethical considerations was performed by an information specialist using a peer-reviewed search strategy according to the PRESS Peer Review of Electronic Search Strategies checklist.⁶⁵ The search strategy is available on request.

Published literature was identified by searching the following bibliographic databases: MEDLINE All (1946‒) via Ovid, the Philosopher’s Index via Ovid, Cumulative Index to Nursing and Allied Health Literature (CINAHL) via EBSCO, and Scopus. All Ovid searches were run simultaneously as a multi-file search. Duplicates were removed using Ovid deduplication for multi-file searches, followed by manual deduplication in Endnote. The search strategy comprised both controlled vocabulary, such as the US National Library of Medicine’s MeSH, and keywords. The main search concepts were chronic cardiac conditions, cardiac rehabilitation, and remote monitoring.

CADTH-developed search filters were applied to limit retrieval to citations related to empirical and normative ethical considerations. Retrieval was not limited by publication date but was limited to English- or French-language documents. The initial search was completed on August 28, 2020. Regular alerts updated the search until the publication of the final report.

Grey literature (literature that is not commercially published) was identified by searching sources listed in relevant sections of the Grey Matters: A Practical Tool for Searching Health-Related Grey Literature checklist.⁶⁶ This includes the websites of regulatory agencies, HTA agencies, clinical guideline repositories, systematic review repositories, patient-related groups, and professional associations. Google was used to search for additional internet-based materials. These searches were supplemented by reviewing bibliographies of key papers and through contacts with experts and industry, as appropriate. See Appendix 1 for more information on the grey literature search strategy.

Selection Criteria

The selection of relevant literature proceeded in 2 stages. In the first stage, the title and abstracts of citations were screened for relevance independently by a single reviewer. Articles were categorized as “retrieve” or “do not retrieve” according to the following criteria:

• Explicitly provides normative analysis of an ethical issue arising in the use of remote monitoring, whether for the treatment of the conditions of interest or more generally.

• Presents empirical research directly addressing an ethical issue arising in the use of remote monitoring.

The goal in a review of bioethics literature is to canvass what arises as an ethical issue from a broad range of relevant perspectives. As such, the quality of normative analysis does not figure in the article selection criteria; any identification of an issue by the public, patients, health care providers, researchers, or policy-makers is of interest, whether presented through rigorous ethical argumentation or not. For example, academic ethicists may focus on certain issues because these relate to theoretical trends in their discipline, while an opinion piece by a clinical or policy leader or a patient experience may bring to the fore ethical questions that are neglected by academic ethicists but are highly pertinent to the assessment of the technology in the relevant context. Despite the different standards of normative argumentation for each kind of report, the importance of the issues raised cannot be assessed solely by these standards and so literature cannot be excluded based on methodological standards.

In the second stage, the full-text reports were reviewed by a single reviewer with ethics expertise. Reports meeting the aforementioned criteria were included in the analysis.

Data Extraction and Abstraction Strategy

The ethical issues identified, values described, and solutions proposed in the literature were evaluated using the methods of ethical (applied philosophical) analysis. This included applying standards of logical consistency and rigour in argumentation, particularly where specific implications are identified and specific solutions advocated; responsiveness to important values of health care and health care policy in the field in which the technology is proposed for implementation; adequacy to the context for which the technology is being considered; and the representation of perspectives from diverse relevant communities, particularly attending to the possibility of the neglect of marginalized and vulnerable populations.

Stakeholders’ Perspectives

Relevant stakeholder perspectives were included via the literature review and the Perspectives and Experiences Review and patient engagement. These sources included patients of varying socioeconomic backgrounds; family members who provide informal care; health care providers, including physicians and nurses; and health systems perspectives. This review focuses on these populations. Some populations and perspectives may be absent not through intentional omission but because there is a lack of health research centred on them (e.g., rural and/or low-income patients, others) or because their perspectives in terms of values are not explicit (e.g., what is important to private industry).

Analysis

What Are the Ethical Issues Related to Remote Monitoring Programs?

Guiding Values

At the core of making an ethically justified decision is this question: What is important and to whom? Another way of framing this is to ask: What values are you trying to achieve through your decision? Answers that are often defaulted to as truisms include “good outcomes” or “efficiencies.” Those are reasonable aims but necessarily raise deeper questions of what values actually underpin them. Efficiency for what aim? Good outcomes in terms of social connectedness or reducing a person’s pain or overall lower hospitalization rates are all important outcomes. How to make sense of values that are in tension is a complex question, with more than 1 right answer, but beyond the scope of this report. It is something that decision-makers should work through for the sake of a successful remote monitoring program.

How is Value and the Corresponding Success of Remote Monitoring Programs Defined?

This is not a question only for the context of remote monitoring programs. It applies to any complex decision-making context that involves many stakeholders with different power who will be impacted by the results. As noted in the seminal work of Bent Flyvbjerg,²¹⁷ parties with power have significant control over which evidence, perspective and/or voices are given consideration, and so effectively have control over what is seen as the rational basis of a good decision.

Without diving more deeply into decision sciences, the takeaway for decision-makers, who likely have authority and power over remote monitoring program decisions, is to reflect on who is empowered to define what is important. This definition of value is what will be measured to assess the success of the program. Although it can add to the challenges of decision-making in the front end, it may lead in the longer term to a more successful program, both in terms of implementation and of having impacts that are most important to those impacted.

What Is Important, What Is Valued, and by Whom?

Table 5 lists values that were named explicitly and implicitly by the groups and individuals involved in the research (both researchers and research participants) around remote monitoring programs.

Are There Value Tensions?

Looking at what is an incomplete list in Table 5, it seems self-evident there are and will be differences and tensions between what is important within and across these broad stakeholder groups.

The literature search revealed 1 value tension concerning different values around surveillance by health professionals of patients that is noteworthy and somewhat unique to remote monitoring programs. First, some patients noted the increased sense of safety they felt based on their understanding of how they would be monitored.^106,115 Living with these cardiac conditions was anxiety provoking, and many patients noted their incomplete understanding of the conditions or what symptoms should provoke action (like seeking emergency care) or not. Remote monitoring technology was felt by some to mean a health professional was monitoring their data, or at least that their data would be available to doctors and nurses at the hospital if needed.¹¹⁵ Depending on the remote monitoring program, this was sometimes in tension with the program’s objectives. In other words, health professionals were not necessarily actively monitoring patients. Nor was information necessarily available and accessible quickly if a patient presented to a hospital. The objective of many, likely most, remote monitoring technologies is not to create a direct stream of data from each patient’s monitoring technology to a health professional 24/7. Anecdotally, patients commonly perceive the “health system” as a singular organization. However, it is more often a complex matrix of actors and systems that work more or less well together as patients move along their journey of care. It can be a surprise, then, when the data collected by the team at one’s cardiac clinic is not readily on-hand when a person presents themselves at an emergency department or even their general practitioner’s clinic.

The preceding example represents in part a mismatch of expectations and understandings and could be overlooked by decision-makers as something to resolve through clearer education materials for patients, and so forth. However, they also represent a more foundational disconnect that will not be rectified simply by telling patients more clearly or more often what to expect from their remote monitoring program. It also seems to be a disconnect between at least 3 parties (possibly more) about what is important, to whom, and how to implement and measure its success.

The example also points toward the tensions that can be inherent to a remote monitoring program because different stakeholder groups and individuals within those groups may hold sometimes incompatible values. For the patient in this rough example, they may value having access to health professionals who will understand their unique condition (based on collected remote monitoring data), and so can better and more quickly respond to any important fluctuations or emergencies, to keep them alive and living well. For providers in this example, they may value that using remote monitoring is more likely to get their patient access and longitudinal support from a specialist. If they are accountable for the remote monitoring program, they might also value its efficiency if it means they can provide services to more patients through fewer in-person appointments, or they may not value it because their workload increases in monitoring more patients or through increased caseloads that do not reduce their workloads. At a health authority level, the program may be valued because it is shown or predicted to reduce hospitalizations (also valued by most patients!) and other benchmarks that may signal good outcomes for the patients in the remote monitoring program, as well as other patients who may benefit from those acute care bed spaces and other resources that may be freed up.

Balance of Benefits and Harms

What Are the Known and Estimated Benefits and Harms for Patients When Implementing or Not Implementing the Technology?

This HTA report does not address clinical benefits and harms through a clinical effectiveness section or a cost section. Therefore, the evidence required to make a rigorous ethics analysis of benefits and harms is not available. However, this weighing of harms and benefits is likely a question of central importance to decision-makers who would have information about the condition(s) being targeted, their status quo, the remote monitoring program option(s) being considered, their patient population(s), their workforce, and so forth. In the final section on addressing ethical considerations, some guidance is provided for decision-makers on how to ensure consideration of benefits and harms are brought into their decisions. The evidence identified through the ethics literature review is incorporated and discussed in the following sections.

Are There Any Ethical Obstacles for Evidence That Are Ethically Consequential?

Because the scope of this assessment did not include an investigation of clinical effectiveness, it is difficult to fully identify obstacles in collecting evidence that are ethically consequential. Few of the studies in the literature review included patients from what could form the target population for a remote monitoring program: rural and remote groups, and populations with low socioeconomic status and other structural conditions correlated to higher rates of the diseases under investigation. This gap in evidence may also imply that the distribution of remote monitoring programs is not equitable or, at the very least, does not reach these populations. No literature explicitly drew this conclusion, so it can only be inferred as a possibility, but it is one that decision-makers should take into consideration. If a jurisdiction considers these or other populations who are not represented in research to be the target of their program, decision-makers might consider a co-designed program with representative patients (and providers), and a phased implementation with regular review before any adjustments and scaling up.

Most of the studies identified in the literature review centred on specialists and less often on patients, and very few examined the family physicians or informal caregivers who are often patients’ most intimate and consistent connections to the health system.

Justice and Equity

Are There Factors That Could Prevent a Group or Person From Gaining Access to a Remote Monitoring Program?

Remote monitoring programs are sometimes promoted or pursued as a means to improve access for patients living outside of urban centres or who experience structural constraints. These constraints may include lower numbers of health professionals or specialists, fewer specialized centres of care, and/or fewer means of transport to access them.

A remote monitoring program is not a fix-all for distributive justice concerns. Decisions about how it is implemented and what is considered within or outside of scope may have a greater impact on overall equity than any remote monitoring program alone. What should decision-makers consider?

In itself, a remote monitoring technology will not transport a patient home from hospital post-surgery, carry heavy equipment into their home if the patient is unable, set up and then learn to operate any programs or equipment, or pay for an internet provider. All of these aspects and others might be necessary for a patient to experience the benefits of a particular remote monitoring technology. As reported through the patient engagement consultations, informal caregivers (in this case, spouses) were a critical component to learning how to operate and set up remote monitoring equipment for patients after surgeries. Likewise, being able to travel to and from appointments and having somewhere affordable to sleep (for the patient or informal caregivers) on trips from rural to urban areas were a critical component to a successful health outcome.

Attention should be paid to the costs borne by patients or their families within the target population and its subgroups. What may be a small expense to some patients and their informal caregivers could be an impossible barrier to others. In the Canadian health care system, care is intended to be distributed equitably — based on one’s need and not one’s ability to pay. Therefore, assumptions about whether a patient has an internet connection, or a phone line, may significantly impact whether they will benefit from, or be burdened by, remote monitoring (see the Perspectives and Experiences Review). Decision-makers may be tempted by programs where patients are encouraged to purchase their own technology, sometimes known colloquially as “bring your own device.” This may be attractive because of reduced program budget costs or patient familiarity with their pre-existing devices. However, it should be approached with caution by decision-makers. It may create a de facto 2-tier program where either wealthier patients have better devices (and correspondingly potentially better outcomes), or additional barriers are created, and less wealthy patients have wait lists or limited access to a small supply of shared or cumbersome technologies (and correspondingly potentially worse outcomes).

Although technology is sometimes presented as the key ingredient to improved experiences and outcomes for patients, the “wraparound” supports provided by health professionals, including at cardiac centres and also in the community, are all critical to patient-centred definitions of success. These also include informal caregivers such as family members and neighbours or support networks, as well as general infrastructure like transportation and telecommunications. They should be considered as part of any decision-making around implementing a remote monitoring program. A lack in any of these components may be easily overcome by patients with personal means, who can pay out-of-pocket for transportation to access care, an at-home paid caregiver, telecommunications, and so forth. Decisions regarding remote monitoring that do not account for these gaps and private costs risk deepening inequities for populations where cardiac challenges are already borne predominantly by those with less means (see the Realist Review).

Rush et al.²²⁷ found in their mixed-method study of rural patients with atrial fibrillation in the Interior of British Columbia that on referral to a cardiologist or electrophysiologist in a larger centre, some older patients “will just say no” due to physical and financial reasons. Their physicians also noted their own reluctance to have patients travel unless absolutely necessary because of both the burden and the mixed quality in outcomes.²²⁷ The siloing of family physicians and cardiologists or cardiology teams was another concern named as relevant.²²⁷ Rural family physicians noted that when their patients did see specialists, they seldom had long-term follow-up, even when a treatment failed. They also noted their concern with referring complex patients who would return with complicated multi-drug regimens that were difficult for cognitively declining patients to manage or were in conflict with other recommendations.²²⁷

This underscores the complex structures (e.g., interprofessional and physician relationships) and challenges (e.g., transportation) that technology alone is unlikely to solve. It also adds weight to the overarching theme of the ethics section; that is, the importance of asking what is important, to whom, what gaps exist that remote monitoring programs (or other program changes) could meet, and whose ends would it support?

How Does Implementation of a Remote Monitoring Program Affect the Distribution of Health Care Resources?

It is possible that as funding and human resources are committed to a remote monitoring program, there may be pressures to transition patients into the new program and away from the existing one. This raises a number of important questions for decision-makers:

• What evidence of benefits and harms exists for your population, and how will the impacts be evaluated at regular intervals to ensure intended outcomes and avoid harms?

• What will be done to support individuals and populations who have structural barriers to using the technology — for example, being unable to afford or acquire internet or phone lines? Will decision-makers ensure equitable access through more traditional (non-remote monitoring) means, or allow the scope of the program to include budgeting for these structural constraints that are sometimes considered non–health care-related constraints?

In cases when these larger scope needs are not met, a program risks exacerbating inequitable health care. As Bauer notes in the context of telemedical services, the “digital divide” of unavailability of or inaccessibility to information technologies is a health care justice problem.²²⁸ Wealthier patients may receive the best health services, while poorer patients or ones with other socially determined health gaps may be left out of scope, no longer fitting the new requirements to receive care. As Bauer notes again, it creates the potential for “the well off and educated [to] have access to medical information and services that the poor and uneducated will not” (p. 249).²²⁸ This becomes more concerning in the context of cardiac conditions because of the intersectional nature of them.

For some patients and providers, a remote monitoring program may lead to better value, according to their definitions. For others, it may lead to negative consequences. This does not mean there is equivalency — that some will win, some will lose. Instead, it is a call to action for decision-makers to ensure they are not creating situations where the circumstances of the worst-off patients will be made even worse or that these patients will be inequitably left out. This may raise the question that if, on the other hand, the goal of decision-makers is centred on cost and resource savings above other values, could it conceivably have this outcome? That is a question that is somewhat context dependent. However, the Realist Review found the following:

As the remote monitoring programs were viewed as being an attractive adjunct as opposed to an alternative to existing health professionals and services, although programs may ultimately reduce avoidable hospitalization (for example for heart failure decompensation), there is a strong likelihood that without careful pathway design and expectations management, remote monitoring programs may increase net costs and workload for host providers during set up and operational phases. This aligns with systematic review of evidence from clinical trials pointing to ongoing uncertainty regarding the cost-effectiveness of remote monitoring programs for cardiac rehabilitation²²⁹ and heart failure populations.²³⁰ The small number of existing studies with cost-analyses fail to calculate full program costs²³⁰ and present very wide estimates.²²⁹ More research is needed to identify the costs and cost-effectiveness of remote monitoring programs across chronic cardiac conditions.

Decision-makers would be prudent to conduct a careful analysis of costs and other resource requirements (both internal and borne by patients) of their specific programs before wide-scale implementation.

Patient Autonomy

Does the Implementation or Use of a Remote Monitoring Program Limit or Affect Patients’ Capacities or Possibilities to Exercise Their Autonomy?

Respect for patient autonomy is a core principle of health care and is about enabling what is important to a patient to guide their life as much as possible. In the context of remote monitoring programs, there are 2 main themes reflected in the literature: patient values and informed consent.

Patient Values

Health care systems, particularly when publicly funded, prioritize the value of benefiting patients. This benefit differs, depending on the patient’s goals and conditions, but often includes some of the following: curing illness, reducing suffering, and maintaining or increasing the ability to flourish using one’s mental and physical capacities.

The more common understanding of the principle of respect for patient autonomy holds that patient values should guide their care as much as possible, within the bounds of what is possible, at a clinical and individual care-planning level. However, it also provides normative guidance at an organizational level of health program and system planning. At this level, respect for patient autonomy posits that what is important to patients should inform decision-makers as to what is possible; in other words, what types of programs achieve the goals of patients, and therefore should get funded.

At a system level, there are many patients with potentially different goals that may or may not be addressed through a remote monitoring program. Further complication occurs if the funding of multiple programs is being considered, and patients with a cardiac condition considered herein are only 1 group among many. That level of resource allocation and priority setting is beyond the scope of this analysis. However, it is worth noting that regardless of which level of decision is being made, patients’ values should be sought to guide and inform what is made possible through those decisions.

Informed Consent

To exercise their autonomy, and have their autonomy respected, it is essential for patients to genuinely know the potential benefits and risks or burdens of a decision before entering into it. This is even more critical in contexts with a fiduciary relationship such as when a health professional or health system has knowledge (or “known unknowns”) about the risks of harm to a patient.

The context of remote monitoring programs can present unique challenges to achieving informed consent. The use of software and applications are sometimes bound by legal user agreements between the owner of the technology or intellectual property and the user and/or patient.²²¹ If a patient is required to relinquish legal rights or allow use of their private health or lifestyle information to access care, this is concerning. This concern may be mitigated by a health program retaining control over patient information, or by careful contracting between a jurisdiction and the third-party provider rather than allowing user agreements between third parties and patients.

An argument could be made that health professionals sometimes require patients to take certain actions, such as exercise or dietary changes, before being considered for a course of treatment that depends on those preceding actions, and that a user agreement is similar. However, this is critically different in at least 2 ways:

1. One is an agreement within a health system, which is bound and accountable to professional colleges, as well as provincial and federal laws. This power over accountability is much less clear and direct if the agents are operating under non-Canadian contexts. Consider the power a provincial college of physicians and surgeons has over a physician who sells patients’ personal health information without consent compared to an international corporation operating under international trade law.

2. For it to be ethically justified to require preceding actions by a patient before they will be granted access to a health program for which they have a health need, these actions must be necessary for the successful treatment of the condition. Signing a user agreement that carries the potential for exposing a patient and/or their genetic relatives to potential harms through the commodification of their health or other information is obviously not necessary for successful treatment.

In a health care setting, it is the responsibility and accountability of various actors, often a most responsible care provider, to understand the potential harms and benefits of any procedure for which they receive patient consent to action. With complex and potentially unclear or changing programs, it may be difficult to know the potential harms that could result from a patient consenting to a private software agreement.

Decision-makers considering remote monitoring programs should pay careful attention to enabling and ensuring genuinely informed consent. The following from Jusob et al.²²⁵ outlines the bounds succinctly:

Informed consent gives patients appropriate knowledge of what data are being collected, how they are stored and used, what rights they have to the data, and what the potential risks of disclosure could be. However, technological literacy limits users’ understanding of the true threats and advantages of technology. Because of the limitation of some users regarding technological literacy, it is necessary to develop mHealth systems that allow patients added control over their data such as, what data are collected and who has permission to access it (p. 250).

Professional Autonomy

How Do Remote Monitoring Programs Limit or Affect Clinicians’ Capacities to Exercise Their Autonomy as Professionals?

Technology design shapes and directs, to varying degrees, what choices are made. This carries normative weight because it can, whether intentionally or unintentionally designed, impact a care provider’s autonomy. The argument in favour of “choice architecture” is that designers can help to ensure that good or at least better decisions are made by users. There is some logic to this; designers may have the opportunity to program the standard of care, consult with experts, and so on. In the context of remote monitoring programs, this could mean that the standard of care for patients may be improved. However, it deserves some due care in choosing the program. As noted in Klugman et al.,²²¹ “when a system provides information to a clinician, the setting of ‘defaults’ represents a powerful and often overlooked way of shaping behavior” (p. 40). What alerts are provided, for what thresholds, and regarding what data, as well as their frequency, can all shape how a care provider acts. If these defaults are difficult or complex to change, or their impacts are unnoticed, this can have unintended consequences on the patient and even the care provider. This again underscores the importance of carefully considering what is important, to whom, and how best to achieve the desired outcomes before implementing a remote monitoring program. For better or worse, remote monitoring programs could result in a reduction or truncation of professional autonomy. In the complexity of clinical care, and the complexity of deciding what is best or valuable, this should be carefully considered by decision-makers.

Privacy and Confidentiality

What Risks Do Remote Monitoring Programs Pose for Patients’ Privacy and Confidentiality?

Privacy overlaps with considerations around patient autonomy and consent (i.e., freedom to make choices about one’s life without interference or coercion). Considerations around structural coercion (e.g., having to accept an invasion of privacy in the terms of use for a technology), or unwanted use of one’s personal health and lifestyle information, have been covered in the preceding section concerning patient autonomy.

In the Canadian cardiac context, home visits by health care providers are not the predominant interaction between patient and provider. However, it is correctly noted by Bauer²²³ that where technology replaces the need for home visits, this can increase the physical privacy of patients and informal caregivers in their homes.

Users of remote monitoring programs face numerous potential risks related to how their health information is used. A summary drawing from Mittelstadt²³¹ and Knorr et al.²³² includes:

• health and life insurance companies seeking health or lifestyle information that is not normally part of their regulated review procedures, impacting access for patients

• discrimination in hiring practices by potential employers, or the monitoring of existing employees’ performance or work absenteeism

• data intelligence companies who commodify demographic information

• law enforcement in many ways; Klugman et al.²²¹ note at least 1 example of law enforcement seeking pacemaker location data.

Some of these risks can be outlined in consent forms, but many are somewhat unprecedented as technology progresses. The profit motives driving some of these privacy risks are not entirely understood by decision-makers, health professionals, or patients. Therefore, informed consent processes may be critically incomplete. Furthermore, as noted already, consent cannot be genuine if it is the only option for access to the standard of care and so is necessarily coercive: consent or suffer potential health consequences.

Applications such as WhatsApp are noted as being increasingly used by health professionals.²³³ Although this falls outside the scope of the remote monitoring programs considered in this HTA, decision-makers should be wary of what guidance for private non-health applications is given to health professionals and also what unintended impacts may be created as a remote monitoring program is rolled out. Do health professionals know what privacy risks exist for patients if using unofficial email services, unencrypted information transfers, or private messaging applications? Does the remote monitoring have a challenging communication interface that might incentivize patients or professionals to shift toward using unapproved applications with potential privacy risks, and so forth?

There are technical concerns around informational privacy that focus on encryption methods for data and risks of breaches through computer hacking.^{225, 234} For an extended discussion and outline of relevant privacy frameworks such as Generally Accepted Privacy Principles, Privacy by Design, and Organisation for Economic Co-operation and Development standards, see Jusob et al.²²⁵

Decision-makers considering a specific remote monitoring program or technology should, if they have access, look to their jurisdiction’s privacy office, research ethics board, and compliance office and health law team for additional support.

How Might These Issues Be Addressed in Rural, Remote, and Urban Settings?

HTA reports generally compare a new technology against the status quo or a comparable intervention. In this case, the broad scope of technologies being reviewed (rather than, for example, a new technology being compared against the existing standard of care) and the focus on implementation decisions (rather than effectiveness) require that the ethical analysis be broad as well. Jurisdictions considering a remote monitoring program may wish to frame their decision-making based on the EUnetHTA Core Model²¹⁶ of considering the ethics of their specific context, and borrowing from the analysis in the preceding sections:

• What are the symptoms and burden of disease or condition for the patients?

• What are the known and assumed benefits and harms for patients when implementing or not implementing the technology?

• What are the known and assumed benefits and harms for relatives, other patients, care providers, the health system, and society?

• In the evidence being used, what are the consequences of the choice of end points, cut-off values, and comparators and/or controls in the studies and/or assessments?

• Are there problems related to the data or the assumptions in the economic evaluation?

• What gaps or pressures exist in current care delivery in our context? Is it a lack of skilled clinicians, a lack of access for patients, issues in quality of care for patients, not enough service hours to respond to the needs of your population, a desire by clinicians or others to be or appear innovative, a drive to cut costs or to allocate budget most effectively and efficiently, and so forth? And, it follows, what type of program may address those gaps or pressures?

In the remote monitoring context, there are numerous stakeholders with various values that are not always compatible. For decision-makers, this should raise the question of what values and/or whose values should take priority when there is a misalignment. Working through this type of context is complex. The preceding ethics analysis is intended to support decision-makers in applying a values-based lens to their decisions.

Patient Engagement

Overview

CADTH involves patients, families, and patient groups to improve the quality and relevance of our assessments, ensuring that those affected by the assessments have an opportunity to contribute to them. CADTH has adopted the CADTH Framework for Patient Engagement in Health Technology Assessment.²³⁵ The framework includes standards for patient involvement in individual assessments and is used to support and guide our activities involving patient collaborators in this Realist Review. Engagement activities occur alongside a review of qualitative studies on perspectives and experiences, including those of patients, and consideration of patient-important outcomes in the clinical review. CADTH engaged 4 patients and 3 caregivers (spouses) with experience of remote monitoring during cardiac rehabilitation and for heart failure care to explore how patients interact with the technology used in monitoring, to identify challenges using the technology, and to confirm treatment outcomes that held meaning for patients and their families. Patient insights helped refine the protocol and interpret the overall findings of the assessment.

Methods

Invitation to Participate

People with lived experience were identified through CADTH’s connections to health care staff operating remote monitoring programs in New Brunswick and with the Canadian Cardiovascular Society, which recommended the HeartLife Foundation. A CADTH patient engagement officer contacted potential participants by email to explore their interest in becoming involved. The preliminary request included the purpose and scope of this project, the purpose of engagement, and the nature of engagement activities. The patient engagement officer obtained the person’s informed consent to share their lived experiences with remote monitoring with CADTH staff. Patient collaborators are recognized and thanked in the report’s Acknowledgements. Collaborators were also offered honorarium for their time and effort.

Engagement Activities

Persons with experience of remote monitoring reflected on if and how the assessment goals and findings resonated with their own personal experiences at several time points during assessment, including:

• prior to protocol finalization

• during drafting of the initial reviews

• upon completion of the final report during the feedback period.

Patients’ insights gained through engagement processes were used to ensure relevance and to provide commentary on themes emerging from the qualitative Perspectives and Experiences Review, and to discuss other key concepts to inform the discussion section. The questions and subsequent discussion with the patient group representatives helped to clarify the technology under review and comment on the relevance of the findings to Canadian patients and families.

The involvement of patient collaborators enabled the research team to consider the evidence alongside an understanding of the wider experiences of patients and family caregivers. The patient and caregiver collaborators were able to identify goals of monitoring from their viewpoint, and to discuss the realities of life with a cardiac condition that requires monitoring.

The patient collaborators and other relevant stakeholders were invited to provide feedback to the report during the stakeholder feedback period. Through conversation and formal reporting, CADTH will clarify the key results of the full assessment and describe how engagement activities were used.

Reporting

The reporting of this section followed the GRIPP2 Short Form reporting checklist.²³⁶

Discussion

The evidence assessed across this report is intended to answer questions about how to best implement remote monitoring programs for cardiac conditions (i.e., heart failure, atrial fibrillation, and hypertension) and cardiac rehabilitation. It also assessed evidence with the intent of providing clarity about who could benefit most from such programs, particularly in relation to the ability of patients to receive care in their home or community while minimizing the need for travel, regardless of whether that home is in a rural, remote, or urban setting.

Overall, the evidence found in this HTA focuses primarily on remote monitoring programs for people with heart failure (see the Realist Review, Perspectives and Experiences Review, and Ethics Review). All sections of this HTA also found some evidence on remote monitoring programs for people participating in cardiac rehabilitation. Less evidence was found for both remote monitoring programs for people with atrial fibrillation (see the Realist Review and Ethics Review) and remote monitoring programs for people with hypertension (see the Perspective and Experiences Review and Ethics Review).

Enabling Optimal Use of Remote Monitoring Programs

An Environmental Scan of Canadian remote monitoring programs for cardiac conditions conducted by CADTH to inform the analyses in this review identified operational barriers and facilitators that may contribute to the successful implementation and maintenance of these programs.⁴² Common barriers identified by respondents included resourcing and funding limitations and cultural and language barriers. Common facilitators identified by respondents included patient engagement and clinician buy-in.

Successfully designing, implementing, and maintaining remote monitoring programs is enabled by a variety of intertwined technical, organizational, and human factors. This review found that, to be most effective, remote monitoring platform technologies must be highly functional and easy to use, incorporate individualized data feedback, and integrate smoothly with patients’ homes and routines, including physical design, network access, and compatibility with other in-home technologies. Although evidence from the Realist Review suggests that the most common technical glitches associated with remote monitoring technologies are relatively minor (i.e., network connectivity issues, battery life), patients and professionals cited the availability of accessible and helpful technical support as key to ensuring program effectiveness. Other factors identified as key to successful technology adoption included device portability and size, and accessibility factors, including options for those with visual or auditory impairments, and functionality and access to technical support in a variety of languages.

Evidence suggests that the ability to tailor programs to the needs of individual patients and informal caregivers is important for program success. For the examined indications, remote monitoring may require considerable learning of self-management techniques and routines on the part of patients and family or informal caregivers, which requires both time and support from the care team. Support from the care team may be particularly important in helping patients work through differences in their perceptions of their own health, when medication adjustments were required, or for conditions like hypertension where there can be considerable fluctuation in measurements.

This HTA found that, in addition to the patient, remote monitoring technologies should address the needs of family and other informal caregivers. Technologies should support caregiver contributions to patient care and address caregivers’ needs for adequate information and support. The Perspectives and Experiences Review identified a conspicuous absence of published evidence on the experiences of family and other informal caregivers, who are often directly implicated in the work of monitoring and providing care, and in the patient’s lifestyle changes.

A notable finding of this report is that although remote monitoring is sometimes conceived of as a replacement to or as an adjunct to regular care (whether in-person or inpatient), both patients and health professionals tend to experience it as complementary or synergistic and as a value-added component of overall care. For this reason, it should not be assumed that implementation of remote monitoring platforms will reduce clinicians’ ongoing workload or decrease patients’ expectations of health providers. For example, in heart failure, remote monitoring platforms appear to increase clinical workload. Evidence from the Perspectives and Experiences Review suggests that integration is key, and that efforts should be made to ensure that remote monitoring activities and data derived from them are integrated into clinical workflows and existing information systems. Remote monitoring may shift care from acute and specialist settings to primary care, which has implications for primary care providers. Additionally, evidence suggests that when implementing remote monitoring programs that serve rural and remote populations with limited access to specialist care, care coordination may pose a challenge. For example, patients who have been discharged from a tertiary centre with a remote monitoring device may experience issues with care coordination between the tertiary centre and local health providers when they seek follow-up care in their own communities.

A key finding of the Ethics Review is that the end goals of remote monitoring programs are not always clear or shared by all who deliver or access the programs. Program administrators, for example, may view remote monitoring programs as a means of reducing costs and finding efficiencies by reducing in-person consultations or acute care admissions. Health professionals involved in the delivery of remote monitoring programs, however, may experience the programs as increasing their workload without a corresponding increase in care quality for their patients. Prior to implementing remote monitoring programs, decision-makers should pause to assess what gaps exist in current care, and what options, including remote monitoring, may exist to meet those needs. This includes examining the needs, concerns, problems, and solutions for treatment and management of the target conditions, with all relevant stakeholders (patients, family and informal caregivers, primary care, and cardiac care teams) at the table.

While this review did not include an analysis of the costs of implementing and maintaining remote monitoring programs, it is important that decision-makers understand they also cannot assume these programs will lower health systems costs as is often believed. For example, a recent analysis seeking to understand the impact of changes in public coverage of remote monitoring services in the US during the COVID-19 pandemic found large cost increases observed during the rapid and sweeping expansion of remote monitoring may only account for a fraction of the potential market for these technologies and it is unclear how these services may persist beyond the pandemic.²³⁷

Who May or May Not Benefit

Understanding that patients and care providers view remote monitoring programs for cardiac conditions as a complementary and additional component of care (and thus potentially not cost or time neutral or cost or time saving), knowing which patients, in which settings, stand to benefit most from these programs becomes an important consideration. This review identified several gaps in the evidence that could make decision-making around patient selection for, and enrolment in, remote monitoring programs challenging.

As observed in the Ethics Review, remote monitoring programs are often framed as a solution for providing care to patients in their homes or communities and as a way to increase patient access to high-quality services. Overall, this review found that the research on remote monitoring programs for cardiac conditions focused predominantly on urban settings, with few studies seeking to understand how patients living in rural, remote, or isolated communities could benefit from these programs.

In addition to a limited scope in contexts of care, this review found the evidence for remote monitoring programs focused on narrow patient samples (i.e., patients in higher income countries) with little evidence about how characteristics such as patient age, sex or gender, income, and race or ethnicity may impact the use and effectiveness of remote monitoring programs. The Realist Review also found little consideration for how these intersecting identities could potentially impact the success of remote monitoring programs. For Canadian decision-makers interested in understanding how remote monitoring programs could complement the care of First Nations, Inuit, and Métis patients, no component of this review identified evidence that included Indigenous people or was concerned with indigeneity.

As discussed in the Patient Engagement section of this report, informal caregivers provide important supports to patients participating in remote monitoring programs for cardiac conditions. Families who collaborated with CADTH on this report shared that informal caregivers (the spouse) carried the main responsibility and burden for remote monitoring in the home. Caregivers learned to use the device, arranged for it to be connected, and made sure it was connected properly. Informal caregivers communicated with the nurse and, in the case of cardiac rehabilitation, arranged for the monitor to be returned after the monitoring period was over. Despite this, the Perspectives and Experiences Review found a conspicuous absence of information about how the lives of family and household members are affected by the presence, use, and demands of remote monitoring in their homes. This knowledge gap was also identified in the Realist Review and the Ethics Review.

That these evidence gaps exist may be surprising to some readers, given a growing body of literature examining the possible impact different lived experiences and identities have on patient outcomes in both the cardiac and chronic conditions spaces.^{182,187,238,239} As noted in the Ethics Review, including the voices of people who are often excluded or marginalized in this research in the decision-making concerning the design and implementation of remote monitoring programs could help to understand the gaps and barriers that actually exist for these groups and help find the best options to address their health care needs (which may or may not include remote monitoring). These evidence gaps also raise questions about the expectations placed on patients and informal caregivers and who may be left out or left behind by remote monitoring programs. If remote monitoring programs work best for people who are motivated to participate and make behavioural changes, have self-efficacy, and are able to raise questions about self-management (see the Perspectives and Experiences Review and Realist Review sections), are these expectations realistic, and when are they not? For example, if remote monitoring programs work best for those most able to make “healthy choices” (e.g., having access to healthy food, the ability to afford it, and a place and time to cook) while people affected by social determinants of health are less likely to benefit, what can be done to improve outcomes in these groups (e.g., putting supports in place, linking to community organizations)?

Conclusions and Implications for Policy-Making

In terms of implications for care decision-makers, the Realist Review draws attention to the importance of particular components of remote monitoring program design. The incorporation of highly individualized clinical information via feedback data to the patient on their condition and progress can maximize the effectiveness of remote monitoring programs for heart failure, atrial fibrillation, and cardiac rehabilitation. This aligns with past meta-analysis of trials of facility-based cardiac rehabilitation programs²⁴⁰ showing that the individualization of components and content for each patient is a prime objective determinant of program effectiveness. It also concurs with more recent evidence that, to be effective, remote monitoring-type programs for diabetes¹⁸⁰ should incorporate individualized information and data feedback to patients.

That said, irrespective of the technical proficiency of programs, program benefits were dependent on the programs integrating well with each individual patient’s context: their daily habits and life patterns. Consequently, future remote monitoring programs for cardiac conditions cannot only be technically proficient but must also be sufficiently adaptive to different patients’ needs. Program designs must have sufficient flexibility to adapt to different patients’ home settings.

Additionally, decision-makers should consider the perhaps less obvious additional work and costs associated with effective remote monitoring programs. There was no evidence that any one demographic group consistently had challenges using the remote monitoring programs studied. However, while the most frequently reported technical glitches with programs were minor (i.e., poor connectivity and short battery life of devices), both patients and professionals indicated that to be effective, remote monitoring programs must have accessible and helpful technical support. Design and funding of remote monitoring programs must therefore ensure that adequate capacity for technical support is in place for a wide range of minor and more major technical issues.

The fact that there was limited evidence on remote monitoring programs delivered in rural or remote settings is significant from a public policy standpoint and is surprising given common assertions that these programs increase access to specialist care in rural and remote populations. Similarly, the gap in evidence around the perspectives, experiences, and needs of family and other informal caregivers is also significant, given the key role caregivers play in supporting remote monitoring patients. Further evaluation is needed to better understand the effectiveness of remote monitoring programs for cardiac conditions in predominantly rural or remote populations, and the impacts on family and informal caregivers. Such evaluation could also be used to support the development of Canadian guidelines for remote monitoring of cardiac conditions (noted as lacking in CADTH’s 2021 Environmental Scan).⁴²

As noted in the Discussion section, little evidence was found on potential moderating effects of patient age, sex or gender, race or ethnicity, and income on program usage and effectiveness. More emphasis should be placed on understanding the experiences of those who may be marginalized and/or have poorer access to technologies, including reliable high-speed internet, and who may experience discrimination in the health system. For Canadian decision-makers interested in understanding how remote monitoring programs could complement the care of First Nations, Inuit, and Métis patients, no component of this report identified evidence that included Indigenous people or was concerned with indigeneity. This evidence gap emphasizes the need for decision-makers to ensure that the voices of people who are often excluded or marginalized are included when designing, implementing, and evaluating remote monitoring programs.

While not considered in the literature reviewed for this report, for policy-makers in jurisdictions where individuals access specialist cardiac care outside their province or territory of residence, limits on cross-jurisdictional practice created by professional licensure and credentialing requirements may also create a barrier to accessing remote monitoring.^{241, 242}

Finally, remote monitoring programs may be an attractive adjunct as opposed to an alternative to existing health professionals and services. Although programs may ultimately reduce avoidable hospitalization (e.g., for heart failure decompensation), there is a strong likelihood that without careful pathway design and expectations management, remote monitoring programs may increase net costs and workload for host providers during set-up and operational phases. This aligns with the systematic review of evidence from clinical trials pointing to ongoing uncertainty regarding the cost-effectiveness of remote monitoring programs for cardiac rehabilitation²²⁹ and heart failure populations.²³⁰ The small number of existing studies with cost analyses fail to calculate full program costs²³⁰ and present very wide estimates.²²⁹ More research is needed to identify the costs and cost-effectiveness of remote monitoring programs across chronic cardiac conditions.

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Appendix 1: Literature Search Strategy

Note that this appendix has been formatted for accessibility but has not been copy-edited.

Realist Review Literature Search

Overview

Interface: Ovid

Databases

• MEDLINE All (1946-present)

• Embase (1974-present)

• APA PyscInfo (1806-present)

• Note: Subject headings and search fields have been customized for each database. Duplicates between databases were removed in Ovid.

Date of search: November 11, 2020

Alerts: Monthly search updates until the end of the completion of stakeholder feedback period.

Study types: No filters were applied to limit the retrieval by study type.

Limits

• Publication date limit: 2010-present

• Humans

• Language limit: English- and French-language

• Conference abstracts: excluded

Table 7: Syntax Guide — Realist Review Literature Search