König Sebastian, Leiner Johannes, Nitsche Anne, Mouratis Konstantinos, Schanner Carolin, Sommerschuh Anett, Hindricks Gerhard, Meier-Hellmann Andreas, Kuhlen Ralf, Bollmann Andreas
Department of Electrophysiology, Heart Center Leipzig at University of Leipzig, Strümpellstraße 39, 04289 Leipzig, Germany.
Leipzig Heart Institute, Russenstrasse 69a, 04289 Leipzig, Germany.
Eur Heart J Digit Health. 2021 Aug 17;2(4):695-698. doi: 10.1093/ehjdh/ztab074. eCollection 2021 Dec.
Digital health technologies have the potential to improve patient care sustainably. A digital capturing of patient-reported outcome measures (PROMs) could facilitate patients' surveillance and endpoint assessment within clinical trials especially in heart failure (HF) patients. However, data regarding the availability of digital infrastructure and patients' willingness to use digital health solutions are scarce. Therefore, we conducted a survey as part of a digital-based HF registry.
The Helios Heart registry (H-registry) has been introduced as a prospective registry being based on digitally augmented processes throughout the whole trial conduction from patients' selection to data collection and follow-up (FU). Patient-reported outcome measures are captured paper-based at recruitment, but patients are offered two digital solutions for FU. Overall, 125 patients (mean age 67.8 years, 34.4% female) were included in the single-centre run-in phase of 16 weeks. Of them, 52.0% were not interested in any digital contact as part of the FU. If digital PROM capturing was conceivable, a web-based solution (70.0%) was preferred to an application-based approach (30.0%). Discrepancies occurred regarding the availability of email accounts and smartphones. Patients in the non-digital group were older (72.0 years vs. 63.2 years, < 0.01) and more frequently female (female sex, non-digital vs. digital group: 47.7% vs. 20.0%, < 0.01).
Our survey illustrated difficulties of implementing a digital FU to record PROMs in a contemporary HF cohort in particular among older patients. Further research is required to specify reasons in case of patients' unwillingness and to better tailor digital health solutions to patients' specific needs.
数字健康技术有潜力可持续地改善患者护理。对患者报告结局指标（PROMs）进行数字化采集有助于在临床试验中对患者进行监测和终点评估，尤其是在心力衰竭（HF）患者中。然而，关于数字基础设施的可用性以及患者使用数字健康解决方案的意愿的数据却很匮乏。因此，我们开展了一项调查作为基于数字技术的心力衰竭注册研究的一部分。
赫利俄斯心脏注册研究（H注册研究）是一项前瞻性注册研究，在从患者选择到数据收集及随访（FU）的整个试验过程中采用数字化增强流程。患者报告结局指标在招募时通过纸质方式采集，但为患者提供了两种用于随访的数字解决方案。总体而言，125名患者（平均年龄67.8岁，34.4%为女性）纳入了为期16周的单中心导入期。其中，52.0%的患者对任何作为随访一部分的数字联系方式不感兴趣。如果可以设想采用数字PROM采集方式，基于网络的解决方案（70.0%）比基于应用程序的方法（30.0%）更受青睐。在电子邮件账户和智能手机的可用性方面存在差异。非数字组的患者年龄更大（72.0岁对63.2岁，P<0.01），女性比例更高（女性，非数字组对数字组：47.7%对20.0%，P<0.01）。
我们的调查表明，在当代心力衰竭队列中，尤其是在老年患者中，实施数字随访以记录PROMs存在困难。需要进一步研究以明确患者不愿意的原因，并更好地根据患者的特定需求定制数字健康解决方案。
