Yamashita Shuhei, Katsumata Yoshinori, Kohsaka Shun, Kitakata Hiroki, Shiraishi Yasuyuki, Yamaoka Koki, Muramoto Yuki, Ono Tomohiko, Shoji Satoshi, Yagyu Keishiro, Oginosawa Yasushi, Kataoka Masaharu, Hashimoto Masahiro, Ko Shigeru B H, Kitagawa Yuko, Jinzaki Masahiro
Department of Cardiology, Keio University School of Medicine, Tokyo, Japan.
Institute for Integrated Sports Medicine, Keio University School of Medicine, Tokyo, Japan.
JAMA Netw Open. 2025 Jan 2;8(1):e2454084. doi: 10.1001/jamanetworkopen.2024.54084.
The integration of patient-reported outcome (PRO) assessments in cardiovascular care has encountered considerable obstacles despite their established clinical relevance.
To assess the impact of a physician- and patient-friendly electronic PRO (ePRO) monitoring system on the quality of cardiovascular care in clinical practice.
DESIGN, SETTING, AND PARTICIPANTS: This open-label, multicenter, pilot randomized clinical trial was phase 2 of a multiphase study that was conducted from October 2022 to October 2023 and focused on the implementation and evaluation of an ePRO monitoring system in outpatient clinics in Japan. During phase 1 (conducted from December 2021 to March 2022), this ePRO monitoring system was developed at a single outpatient center using feedback from patients and physicians. Eligible patients were older than 18 years with a clinical diagnosis of heart failure (HF), atrial fibrillation (AF), or coronary artery disease (CAD). Participants were randomly assigned 1:1 to either the ePRO or control group. Statistical analysis was based on the intention-to-treat approach.
Patients in the ePRO group were asked to complete the 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12), Atrial Fibrillation Effect on Quality-of-Life Questionnaire (AFEQT), or Seattle Angina Questionnaire (SAQ) on smart tablets before their clinical examination. Results were reviewed by physicians at each outpatient visit. The control group received usual care consisting of medication management, lifestyle modification, and invasive procedures in accordance with clinical guidelines. Both groups had 5 monthly outpatient visits.
Patient satisfaction, quality of information (QOI) provided by physicians, and disease knowledge were assessed using questionnaires (eg, Patient Satisfaction Questionnaire [PSQ]; score range: 5-25, with higher scores indicating greater patient satisfaction) at baseline and the fifth visit, over approximately 4 months.
Of the 50 patients included, 48 (median [SD] age, 71.0 [62.3-75.0] years; 28 males [58.3%]) completed follow-up. The prevalence was 56.2% (n = 27) for HF, 75.0% (n = 36) for AF, and 10.4% (n = 5) for CAD. The distribution of PRO measures used was 21 patients (43.8%) for KCCQ-12, 24 (50.0%) for AFEQT, and 3 (6.2%) for SAQ. Compared with the control group, the ePRO group showed significant improvements in mean (SD) PSQ score (0.16 [2.06] vs 1.61 [1.75]; P = .01) and QOI score regarding treatment (-0.12 [0.53] vs 0.35 [0.71]; P = .01). The ePRO group exhibited a greater increase in the PSQ score regarding communication (-0.12 [0.53] vs 0.43 [0.90]; P = .01).
In this randomized clinical trial, implementation of the ePRO monitoring system significantly enhanced patient-physician communication and the clarity of physicians' explanations about treatment. These findings suggest that the ePRO monitoring system is capable of supporting patient-centered cardiovascular care.
University Hospital Medical Information Network Identifier: UMIN000049251.
尽管患者报告结局（PRO）评估在心血管护理中具有既定的临床相关性，但其整合仍遇到了相当大的障碍。
评估一种对医生和患者友好的电子PRO（ePRO）监测系统对临床实践中心血管护理质量的影响。
设计、设置和参与者：这项开放标签、多中心、试点随机临床试验是一项多阶段研究的第2阶段，该研究于2022年10月至2023年10月进行，重点是在日本门诊诊所实施和评估ePRO监测系统。在第1阶段（2021年12月至2022年3月进行），该ePRO监测系统在一个门诊中心利用患者和医生的反馈进行开发。符合条件的患者年龄在18岁以上，临床诊断为心力衰竭（HF）、心房颤动（AF）或冠状动脉疾病（CAD）。参与者被1:1随机分配到ePRO组或对照组。统计分析基于意向性治疗方法。
ePRO组患者被要求在临床检查前在智能平板电脑上完成12项堪萨斯城心肌病问卷（KCCQ - 12）、心房颤动对生活质量问卷（AFEQT）或西雅图心绞痛问卷（SAQ）。每次门诊就诊时医生会查看结果。对照组接受常规护理，包括根据临床指南进行药物管理、生活方式改变和侵入性操作。两组均有5次每月门诊就诊。
在基线和大约4个月后的第5次就诊时，使用问卷（如患者满意度问卷[PSQ]；评分范围：5 - 25，分数越高表明患者满意度越高）评估患者满意度、医生提供的信息质量（QOI）和疾病知识。
纳入的50例患者中，48例（年龄中位数[标准差]，71.0[62.3 - 75.0]岁；28例男性[58.3%]）完成了随访。HF的患病率为56.2%（n = 27），AF为75.0%（n = 36），CAD为10.4%（n = 5）。所使用的PRO测量方法的分布为：KCCQ - 12有21例患者（43.8%），AFEQT有24例（50.0%），SAQ有3例（6.2%）。与对照组相比，ePRO组在平均（标准差）PSQ评分（0.16[2.06]对1.61[1.75]；P = 0.01）和关于治疗的QOI评分（ - 0.12[0.53]对0.35[0.71]；P = 0.01）方面有显著改善。ePRO组在关于沟通的PSQ评分方面有更大的增加（ - 0.12[0.53]对0.43[0.90]；P = 0.01）。
在这项随机临床试验中，ePRO监测系统的实施显著增强了医患沟通以及医生对治疗解释的清晰度。这些发现表明ePRO监测系统能够支持以患者为中心的心血管护理。
大学医院医学信息网络标识符：UMIN000049251。
