Abstract
BackgroundCapacity to deliver outpatient care for patients with cardiac implantable electronic devices (CIEDs) may soon be outweighed by need. This systematic review aims to investigate the comparative effectiveness, safety, and cost for virtual or remote clinic interventions for patients with CIEDs and explores how outcomes may be influenced by patient or system factors in-depth.MethodsWe will perform a systematic literature search in MEDLINE, Embase, PsycINFO, CINAHL, Proquest Dissertations & Theses, other EBM Reviews, and trial registry databases. Two authors will independently screen titles and abstracts for eligibility. We will include randomized and non-randomized controlled trials, quasi-randomized and experimental studies, cohort, and case-control studies. Study populations of interest are individuals with a CIED (pacemaker, ICD, CRT). Eligibility will be restricted to virtual or remote follow-up or care interventions compared to any other approach. The co-primary outcomes of interest are mortality and patient satisfaction. Secondary outcomes include clinical effectiveness (e.g., ICD shock, time-to-detection of medical event, hospitalizations), safety (e.g., serious or device-related adverse events), device efficacy (e.g., transmissions, malfunctions), costs, workflow (e.g., resources, process outcomes, time-saved), and patient reported (e.g., burden, quality of life). Data will be extracted by one author and checked by a second using a standardized template. We will use published frameworks to capture data relevant to intervention effects that may be influenced by intervention definition or complexity, context and setting, or in socially disadvantaged populations. Detailed descriptive results will be presented for all included studies and outcomes, and where feasible, synthesized using meta-analysis. Risk of bias will be assessed by two review authors independently using Cochrane Risk of Bias tools. Certainty of evidence will be assessed using the GRADE approach.DiscussionIncreases in number of CIEDs implanted, combined with an aging population and finite health resource allocations at the system-level may lead to increased reliance on virtual follow-up or care models in the future. These models must prioritize consistent, equitable, and timely care as a priority. Results from this systematic review will provide important insight into the potential contextual factors which moderate or mediate the effectiveness, safety, and cost of virtual follow-up or care models for patients.Systematic review registrationPROSPERO registration number CRD42020145210
Highlights
Capacity to deliver outpatient care for patients with cardiac implantable electronic devices (CIEDs) may soon be outweighed by need
Clinicians who support the use of virtual follow-up for patients with CIEDs have noted that outside of the research environment, there are issues with the delivery of timely, uniform, and efficient arrhythmia care in practice across health jurisdictions, and uptake is not optimal [15, 16]. It is unclear if the health and system benefits identified in individual research studies involving virtual follow-up for CIEDs are being realized in practice, and evidence syntheses have not found significant effects on cardiovascular or all-cause mortality, stroke, hospitalization when randomized studies are pooled
The present systematic review protocol outlines our approach to comprehensively review the evidence for the comparative clinical effectiveness, safety, and cost-effectiveness of virtual follow-up or care models for patients with CIEDs while considering the complexity of the intervention and the system in which it interacts, and the impact of context and setting
Summary
This protocol was written a priori and will be followed throughout the study process. Any deviations from this protocol will be disclosed in all related publications, and the PROSPERO record will be updated (CRD42020145210). All research questions will be addressed by a de novo systematic review of published clinical evidence. Research questions The systematic review will address the primary research question: What are the comparative clinical effectiveness, safety, and cost of virtual follow-up or care models for patients with CIEDs?. Several subsets of the research question will be addressed to capture the complexity of virtual follow-up or care and the context in which it is delivered: 1. 2. How do the components of virtual follow-up/care interventions work alone or in combination to produce effects?
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