Timmermans Ivy, Meine Matias, Zitron Edgar, Widdershoven Jos, Kimman Geert, Prevot Sébastien, Rauwolf Thomas, Anselme Frédéric, Szendey Istvan, Romero Roldán Javier, Mabo Philippe, Schaer Beat, Denollet Johan, Versteeg Henneke
Department of Cardiology, University Medical Center Utrecht, 3508, GA, Utrecht, the Netherlands.
CoRPS - Center of Research on Psychology in Somatic Diseases, Department of Medical and Clinical Psychology, Tilburg University, 5000, LE, Tilburg, the Netherlands.
Pacing Clin Electrophysiol. 2017 Jul;40(7):826-833. doi: 10.1111/pace.13123. Epub 2017 Jun 30.
Studies have shown that remote patient monitoring (RPM) of implantable cardioverter defibrillators (ICDs) is at least comparable to in-clinic follow-up with regard to clinical outcomes and might be cost-effective, yet RPM is not standard clinical practice within Europe. Better insight into the patient perspective on RPM may aid in its acceptance, implementation, and reimbursement. This narrative review (1) summarizes existing evidence on the impact of RPM on patient-reported outcomes and (2) discusses future directions in examining the patient perspective.
Literature review indicated that only five randomized trials on RPM in ICD patients included patient-reported outcomes, with inconclusive results. Observational studies show a trend toward good patient satisfaction and acceptation of RPM. Yet, results should be interpreted with caution due to a number of limitations including a potential selection bias, use of generic/nonvalidated questionnaires, relatively short follow-up durations, and a lack of subgroup identification.
Although RPM seems to be safe, effective, timely, and efficient, the patient perspective has received little attention so far. The scarce evidence on patient-reported outcomes in RPM studies seems to be positive, but future trials with a follow-up of ≥12 months and validated patient-reported outcome measures are needed. The REMOTE-CIED study from our group is the first prospective randomized controlled trial primarily designed to examine the patient perspective on RPM, and is powered to identify characteristics associated with RPM satisfaction and benefit. Results are expected in 2018 and will add valuable information to the current evidence.
研究表明,植入式心律转复除颤器(ICD)的远程患者监测(RPM)在临床结局方面至少与门诊随访相当,并且可能具有成本效益,但RPM在欧洲并非标准临床实践。更好地了解患者对RPM的看法可能有助于其被接受、实施和报销。本叙述性综述(1)总结了关于RPM对患者报告结局影响的现有证据,(2)讨论了在研究患者观点方面的未来方向。
文献综述表明,在ICD患者中关于RPM的随机试验中,只有五项纳入了患者报告结局,结果尚无定论。观察性研究显示患者对RPM的满意度和接受度有良好趋势。然而,由于一些局限性,包括潜在的选择偏倚、使用通用/未经验证的问卷、随访时间相对较短以及缺乏亚组识别,结果应谨慎解释。
尽管RPM似乎安全、有效、及时且高效,但到目前为止患者的观点很少受到关注。RPM研究中关于患者报告结局的证据稀少,但似乎是积极的,不过未来需要进行随访时间≥12个月且采用经过验证的患者报告结局测量方法的试验。我们团队的REMOTE-CIED研究是第一项主要旨在研究患者对RPM看法的前瞻性随机对照试验,有能力识别与RPM满意度和获益相关的特征。预计2018年得出结果,将为当前证据增添有价值的信息。