School of Public Health, Bielefeld University, Bielefeld, Germany.
Department of Medicine I, University Hospital Munich, Ludwig Maximilians University, Munich, Germany.
Clin Res Cardiol. 2021 Jun;110(6):789-800. doi: 10.1007/s00392-020-01667-0. Epub 2020 May 16.
Impact of telemedicine with remote patient monitoring (RPM) in implantable cardioverter-defibrillator (ICD) patients on clinical outcomes has been investigated in various clinical settings with divergent results. However, role of RPM on patient-reported-outcomes (PRO) is unclear. The INFRARED-ICD trial aimed to investigate the effect of RPM in addition to standard-of-care on PRO in a mixed ICD patient cohort.
Patients were randomized to RPM (n = 92) or standard in-office-FU (n = 88) serving as control group (CTL). At baseline and on a monthly basis over 1 year, study participants completed the EQ-5D questionnaire for the primary outcome Quality of Life (QoL), the Hospital Anxiety and Depression Scale, and the Florida Patient Acceptance Survey questionnaire for secondary outcomes. Demographic characteristics (82% men, mean age 62.3 years) and PRO at baseline were not different between RPM and CTL. Primary outcome analysis showed that additional RPM was not superior to CTL with respect to QoL over 12 months [+ 1.2 vs. + 3.9 points in CTL and RPM group, respectively (p = 0.24)]. Pre-specified analyses could not identify subgroups with improved QoL by the use of RPM. Neither levels of anxiety (- 0.4 vs. - 0.3, p = 0.88), depression (+ 0.3 vs. ± 0.0, p = 0.38), nor device acceptance (+ 1.1 vs. + 1.6, p = 0.20) were influenced by additional use of RPM.
The results of the present study show that PRO were not improved by RPM in addition to standard-of-care FU. Careful evaluation and planning of future trials in selected ICD patients are warranted before implementing RPM in routine practice.
在不同的临床环境中，已经研究了远程患者监测（RPM）的远程医疗对植入式心律转复除颤器（ICD）患者临床结局的影响，结果不尽相同。然而，RPM 对患者报告结局（PRO）的作用尚不清楚。INFRARED-ICD 试验旨在研究 RPM 除标准护理外对混合 ICD 患者队列中 PRO 的影响。
患者被随机分配到 RPM（n=92）或标准门诊随访（n=88）作为对照组（CTL）。在基线和 1 年内每月一次，研究参与者完成 EQ-5D 问卷以评估主要结局生活质量（QoL），医院焦虑和抑郁量表以及佛罗里达患者接受度调查问卷以评估次要结局。RPM 和 CTL 组之间的人口统计学特征（82%为男性，平均年龄 62.3 岁）和 PRO 基线无差异。主要结局分析表明，在 12 个月内，额外的 RPM 并没有优于 CTL 的 QoL[CTL 和 RPM 组分别增加了+1.2 和+3.9 分（p=0.24）]。预先指定的分析未能确定通过使用 RPM 提高 QoL 的亚组。RPM 的使用也没有影响焦虑水平（-0.4 与-0.3，p=0.88）、抑郁水平（+0.3 与±0.0，p=0.38）或设备接受度（+1.1 与+1.6，p=0.20）。
本研究结果表明，在标准护理随访的基础上，PRO 并未因 RPM 的额外使用而得到改善。在将 RPM 纳入常规实践之前，需要对选定的 ICD 患者进行未来试验的仔细评估和规划。
