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Table 1 Eligibility criteria for the research questions

From: Virtual follow-up and care for patients with cardiac electronic implantable devices: protocol for a systematic review

Population

Adults or children (any gender) with a CIED (pacemaker, ICD, CRT). Device may be de novo, existing, or in a patient undergoing a pulse generator change that now has virtual follow-up or care capabilities.

Exclusions:

• Patients with implantable loop recorders.

Intervention

Virtual follow-up may also be referred to as remote monitoring. In this study we broadly include the collection of device or patient data and/or diagnostics via passive remote device interrogations and the automated transmission of active pre-specified alerts related to device functionality and clinical events. This involves a one-way transmission of data from the patient in their outpatient setting to a receptor device or specialty clinic. Here, the patient alternates virtual follow-up from home with in-person device clinic visits (6 month intervals for ICDs/CRT, 12 month intervals for pacemakers). This can be utilized for any CIED (pacemakers, ICDs, or CRTs) which have the capability. Virtual follow-up is most often suited for patients with stable device function and adequate battery longevity after at least one in-person post-surgical follow-up visit.

Virtual care may also be referred to as remote patient management and involves therapeutic intervention on the patient’s implanted CIED from a distance using available technology (e.g., remotely re-programming device thresholds, automated recalibration of device settings using machine-learning algorithms). This involves two-way interaction and is informed by virtual follow-up through transmission of data from patient in their outpatient (or non-device clinic) setting to a receptor device clinic and then related care or action involving some kind of therapeutic adjustment from a physician (or qualified individual) at the receptor device clinic back to the patient’s device. This eliminates the need for travel to a specialty device clinic, with exceptions for changes in medical status, battery replacement, or re-implant. Follow-up remains the same from home but patient may be required to travel from home to a local provider for virtual care intervention. This approach may also be accompanied by additional interventions aimed at patient self-efficacy and empowerment (e.g., providing a patient with their own data). Any virtual therapeutic intervention for CIED patients is considered in-scope for this review.

Exclusions:

• Biometric, non-device-related patient data (e.g., blood pressure, weight) follow-up via telecardiology.

Comparators

Any (standard care, in-clinic care, transtelephonic monitoring, a different virtual follow-up, or care modela)

Outcomesb

Primary outcomes: mortality (all), patient satisfaction with care

Secondary outcomes:

Clinical effectiveness: Cardiovascular mortality, stroke, ICD shocks (total, appropriate, inappropriate), arrhythmias (pacemaker patients only), time to detection of medical events (time to detection of ventricular arrhythmias, time to detection of atrial fibrillation, time to initiation of anti-coagulation in patients with new device-detected atrial fibrillation, time to detection of device infection, time to detection of device malfunction [including lead malfunction], time from detected medical event to action/decision, time to detection of suboptimal biventricular pacing (defined as < 90% in CRT patients only)), worsening NYHA functional class, response to CRT, total clinic visits (total, scheduled, unscheduled), emergency department visits, hospitalizations (all, device-related, for heart failure, or of cardiovascular cause), length of hospital stay, patient compliance, patient adherence.

Patient-reported or important: Activities of daily living, burden, self-efficacy, quality of life, empowerment

Device efficacy: system set-up (attempts, success, failure), transmissions (total, unsuccessful, successful), malfunctions with system, alerts, or data

Safety: adverse events attributable to intervention, serious adverse events

Costs: any cost or resource use data identified will be of interest (related to the patient, clinic, or system). These must be economic elements, expressed as quantifiable outcomes or change in outcomes.

Workflow/operational: staff/physician resources or time, time per “appointment,” process efficiencies, use of time for education or technical training, proportion of clinic patients using virtual follow-up or care, telephone calls made (by type if reported).

Other: Study withdrawals, group crossovers, composite endpoints involving any of the above outcomes. Equity in terms of geographic/socio-economic access or reach, impact to PROGRESS+ factors.

Study design

Randomized controlled trials, non-randomized controlled trials, quasi-randomized studiesc, cohort studies (prospective, retrospective, historical)d, case-control studies, quasi-experimental studies.

Studies may be from peer-reviewed publications, trial registry records, conference abstracts, letters, presentations, or thesis/dissertation documents. Protocols and trial registry records that meet eligibility criteria will be included, investigated for publication bias, and will be documented or summarized as indicators of “in progress” research.

Exclusions: Case reports, case series, review articles, cross-sectional studies, surveys, qualitative or interview/focus group studies, editorials, letters, and commentaries.

Context/setting

Any setting or context.

All outcomes will be explored for meaningful differences measured by contextual factors, or those related to the setting of the device clinic or patient. Differences in PROGRESS-PLUS factors will be of interest, as well as any specified stratified reporting of findings, or evidence of moderating or mediating effects of context or setting.

Time frame

January 1, 2000, to present.

Language

No limitations.

  1. CIED cardiovascular implantable electronic device, ICD implantable cardioverter defibrillator, CRT cardiac resynchronization therapy
  2. a“A different virtual follow-up or care model” means any virtual follow-up or care model compared with any other virtual follow-up or care model (i.e., virtual follow-up or care models compared with each other)
  3. bAll outcomes are considered to be important based on the scoping exercises that informed this review and involved consultation with more than one clinical expert in cardiology and electrophysiology
  4. cA quasi-experimental design is an empirical interventional study used to associate outcomes of an intervention on a group of sampled participants without random assignment. For example, pretest-posttest, and interrupted time-series designs
  5. dCohort studies are defined as studies in which a defined group of participants (the cohort) are sampled on the basis of exposure (interventions received) and in which subsequent outcomes and the association with different interventions received are assessed in a follow-up period of time. This is differentiated from case series studies, in which observations are made on a series of participants, usually all receiving the same intervention and who are followed over a defined time to examine subsequent outcomes, without a control group