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Pragmatism and Digitization in Cardiovascular Research

A special issue of Journal of Clinical Medicine (ISSN 2077-0383). This special issue belongs to the section "Cardiovascular Medicine".

Deadline for manuscript submissions: closed (15 January 2024) | Viewed by 6261

Special Issue Editor


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Guest Editor
Division of Cardiology, Duke University School of Medicine, Durham, NC 27710, USA
Interests: heart failure; cardiometabolics; interventional cardiology; cardiovascular medicine

Special Issue Information

Dear Colleagues,

Results from randomized controlled trials (RCTs) have transformed medicine from a field that was anecdote-driven into one that is evidence-based. However, conventional RCTs can be expensive, time intensive, and complex to conduct. Trial recruitment, participation, and data collection can also burden participants and research personnel. Moreover, the majority of cardiovascular RCTs test interventions in selected populations under explicitly protocol-defined settings, limiting the generalizability of findings. Therefore, the emphasis on the need for increased pragmatism and decentralization of clinical trials has increased recently. In this context, the concept of ‘pragmatism’ addresses concerns regarding the limited generalizability of findings in cardiovascular research, and optimizes effectiveness over efficacy evaluation. Moreover, the use of digital health technologies and embedding of RCTs into existing electronic health record (EHR) systems, registries, or administrative databases can streamline patient recruitment, consent, randomization, follow-up visits, surveillance and adjudication of outcomes.

This Special Issue of Journal of Clinical Medicine will focus on the need for "Pragmatism and Digitization in Cardiovascular Research". Potential topics include, but are not limited to:

  1. Original studies using digital technologies and pragmatic approaches for evidence generation;
  2. Current challenges and potential solutions to the implementation of pragmatism into clinical trials;
  3. Current challenges and potential solutions to the use of digital health technologies in evidence generation;
  4. Leveraging electronic health records or administrative databases for evidence generation;
  5. Outcomes adjudication in clinical trials;
  6. Current landscape of registry-based trials.

We welcome papers that address this broad topic to update its research progress.

Dr. Muhammad Shahzeb Khan
Guest Editor

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Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2600 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • cardiovascular
  • heart failure
  • cardiometabolic
  • interventional cardiology
  • clinical trials
  • randomized controlled trials (RCTs)
  • pragmatism
  • digitization
  • digital technologies
  • pragmatic design
  • electronic health record (EHR)

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Published Papers (2 papers)

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Research

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10 pages, 1361 KiB  
Article
Patient Perspectives on Digital Interventions to Manage Heart Failure Medications: The VITAL-HF Pilot
by Marc D. Samsky, Renee Leverty, James M. Gray, Alexandra Davis, Brett Fisher, Ashul Govil, Tom Stanis and Adam D. DeVore
J. Clin. Med. 2023, 12(14), 4676; https://doi.org/10.3390/jcm12144676 - 14 Jul 2023
Cited by 5 | Viewed by 1687
Abstract
Use of guideline-directed medical therapy (GDMT) for treatment of heart failure with reduced ejection fraction (HFrEF) remains unacceptably low. The purpose of this study was to determine whether a digital health tool can augment GDMT for patients with HFrEF. Participants ≥ 18 years [...] Read more.
Use of guideline-directed medical therapy (GDMT) for treatment of heart failure with reduced ejection fraction (HFrEF) remains unacceptably low. The purpose of this study was to determine whether a digital health tool can augment GDMT for patients with HFrEF. Participants ≥ 18 years old with symptomatic HFrEF (left ventricular ejection fraction ≤ 40%) and with access to a mobile phone with internet were included. Participants were given a blood pressure cuff, instructed in its use, and given regular symptom surveys via cell-phone web-link. Data were transmitted to the Story Health web-based platform, and automated alerts were triggered based on pre-specified vital sign and laboratory data. Health coaches assisted patients with medication education, pharmacy access, and lab access through text messages and phone calls. GDMT titration plans were individually created in the digital platform by local clinicians based on entry vitals and labs. Twelve participants enrolled and completed the study. The median age and LVEF were 52.5 years (IQR, 46.5–63.5) and 25% (IQR, 22.5–35.5), respectively. There were 10 GDMT initiations, 52 up-titrations, and 13 down-titrations. Five participants engaged in focus-group interviews following study completion to understand first-hand perspectives regarding the use of digital tools to manage GDMT. Participants expressed comfort knowing that there were clinicians regularly reviewing their data. This alleviated concerns of uncertainty in daily living, led to an increased feeling of security, and empowered patients to understand decision-making regarding GDMT. Frequent medication changes, and the associated financial impact, were common concerns. Remote titration of GDMT for HFrEF is feasible and appears to be a patient-centered approach to care. Full article
(This article belongs to the Special Issue Pragmatism and Digitization in Cardiovascular Research)
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Review

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18 pages, 2497 KiB  
Review
Heart Failure Remote Monitoring: A Review and Implementation How-To
by Elizabeth A. Kobe, Todd McVeigh, Ishaque Hameed and Marat Fudim
J. Clin. Med. 2023, 12(19), 6200; https://doi.org/10.3390/jcm12196200 - 26 Sep 2023
Cited by 6 | Viewed by 3766
Abstract
Heart failure (HF) is a significant clinical and financial burden worldwide. Remote monitoring (RM) devices capable of identifying early physiologic changes in decompensation have the potential to reduce the HF burden. However, few trials have discussed at length the practical aspects of implementing [...] Read more.
Heart failure (HF) is a significant clinical and financial burden worldwide. Remote monitoring (RM) devices capable of identifying early physiologic changes in decompensation have the potential to reduce the HF burden. However, few trials have discussed at length the practical aspects of implementing RM in real-world clinical practice. The present paper reviews current RM devices and clinical trials, focusing on patient populations, outcomes, data collection, storage, and management, and describes the implementation of an RM device in clinical practice, providing a pragmatic and adaptable framework. Full article
(This article belongs to the Special Issue Pragmatism and Digitization in Cardiovascular Research)
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