Novel Trial Designs in Heart Failure: Using Digital Health Tools to Increase Pragmatism.

IF 3.8 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Current Heart Failure Reports Pub Date : 2024-02-01 Epub Date: 2023-12-28 DOI:10.1007/s11897-023-00640-y

Adam D DeVore, Marat Fudim, Lars H Lund

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Abstract

Purpose of review: Heart failure is an important clinical and public health issue. There is an urgent need to improve the efficiency of clinical trials in heart failure to rapidly identify new therapies and evidence-based implementation strategies for currently existing therapies. Electronic health (eHealth) platforms and digital health tools are being integrated into heart failure care. In this manuscript, we review opportunities to use these tools to potentially improve the design of and reduce the complexity of clinical trials in heart failure.

Recent findings: The PRECIS-2 tool outlines clinical trial design domains that are targets for pragmatism. We believe incorporating pragmatic design elements with the aid of eHealth platforms and digital health tools into clinical trials may help address the current complexity of clinical trials in heart failure and improve efficiency. In the manuscript, we provide examples from recent clinical trials across clinical trial design domains. We believe the current adoption of eHealth platforms and digital health tools is an opportunity improve the design of heart failure clinical trials. We specifically believe these tools can enhance pragmatism in clinical trials and reduce delays in generating high-quality evidence for new heart failure therapeutics.

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心力衰竭的新型试验设计：使用数字健康工具提高实用性。

审查目的：心力衰竭是一个重要的临床和公共卫生问题。目前迫切需要提高心力衰竭临床试验的效率，以快速确定新疗法和现有疗法的循证实施策略。电子健康（eHealth）平台和数字健康工具正被整合到心衰护理中。在本手稿中，我们回顾了利用这些工具改进心衰临床试验设计并降低其复杂性的机会：PRECIS-2 工具概述了作为实用主义目标的临床试验设计领域。我们认为，借助电子健康平台和数字健康工具在临床试验中融入实用主义设计元素有助于解决目前心衰临床试验的复杂性并提高效率。在手稿中，我们提供了近期临床试验中各个临床试验设计领域的实例。我们认为，目前电子健康平台和数字健康工具的采用是改善心衰临床试验设计的一个契机。我们特别相信，这些工具可以提高临床试验的实用性，减少为心衰新疗法提供高质量证据的延误。

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来源期刊

Current Heart Failure Reports Medicine-Emergency Medicine

CiteScore

5.30

自引率

0.00%

发文量

期刊介绍： This journal intends to provide clear, insightful, balanced contributions by international experts that review the most important, recently published clinical findings related to the diagnosis, treatment, management, and prevention of heart failure. We accomplish this aim by appointing international authorities to serve as Section Editors in key subject areas, such as investigative, pharmacologic, and nonpharmacologic therapies, pathophysiology, and prevention. Section Editors, in turn, select topics for which leading experts contribute comprehensive review articles that emphasize new developments and recently published papers of major importance, highlighted by annotated reference lists. An international Editorial Board reviews the annual table of contents, suggests articles of special interest to their country/region, and ensures that topics are current and include emerging research. Commentaries from well-known figures in the field are also provided.

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