首页> 美国卫生研究院文献>Annals of Noninvasive Electrocardiology >REmote SUpervision to Decrease HospitaLization RaTe. Unified and integrated platform for data collected from devices manufactured by different companies: Design and rationale of the RESULT study
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REmote SUpervision to Decrease HospitaLization RaTe. Unified and integrated platform for data collected from devices manufactured by different companies: Design and rationale of the RESULT study

机译:远程监控以减少住院率。从不同公司生产的设备收集的数据的统一和集成平台:RESULT研究的设计和原理

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摘要

The number of patients with heart failure implantable cardiac electronic devices ( s) is growing. Hospitalization rate in this group is very high and generates enormous costs. To avoid the need for hospital treatment, optimized monitoring and follow‐up is crucial. Remote monitoring ( ) has been widely put into practice in the management of s but it may be difficult due to the presence of differences in systems provided by device manufacturers and loss of gathered data in case of device reimplantation. Additionally, conclusions derived from studies about usefulness of in clinical practice apply to devices coming only from a single company. An integrated monitoring platform allows for more comprehensive data analysis and interpretation. Therefore, the primary objective of Remote Supervision to Decrease Hospitalization Rate ( ) study is to evaluate the impact of on the clinical status of patients with s or ‐Ds using an integrated platform. Six hundred consecutive patients with s or ‐Ds implanted will be prospectively randomized to either a traditional or ‐based follow‐up model. The primary clinical endpoint will be a composite of all‐cause mortality or hospitalization for cardiovascular reasons within 12 months after randomization. The primary technical endpoint will be to construct and evaluate a unified and integrated platform for the data collected from devices manufactured by different companies. This manuscript describes the design and methodology of the prospective, randomized trial designed to determine whether remote monitoring using an integrated platform for different companies is safe, feasible, and efficacious (ClinicalTrials.gov Identifier: 02409225).
机译:具有心力衰竭的可植入心脏电子设备的患者数量正在增长。该组的住院率很高,并产生巨大的费用。为了避免需要医院治疗,优化监控和随访至关重要。远程监控()已在s的管理中广泛实践,但是由于设备制造商提供的系统存在差异以及在重新植入设备的情况下丢失了收集的数据,因此可能会很困难。此外,从临床实践中的有效性研究得出的结论仅适用于仅来自一家公司的设备。集成的监控平台可进行更全面的数据分析和解释。因此,降低住院率的远程监管研究的主要目标是使用集成平台评估s或ds患者临床状况的影响。连续将600名植入s或-D的患者前瞻性地随机分为传统或基于随访模型。主要临床终点将是随机分组后12个月内因心血管原因导致的全因死亡率或住院治疗的综合结果。主要技术目标是为从不同公司生产的设备收集的数据构建和评估一个统一的集成平台。该手稿描述了前瞻性随机试验的设计和方法,该试验旨在确定使用集成平台对不同公司进行远程监控是否安全,可行和有效(ClinicalTrials.gov标识符:02409225)。

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