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The results of a pilot trial (UMIN000049251) published by JAMA Network Open showed the efficacy of a user-friendly electronic patient-reported outcome (ePRO) monitoring system in enhancing patient-centered care by improving communication with physicians.1,2 The study authors noted the importance of patient-reported outcomes (PROs) evaluations in the ability to record symptoms and the subsequent impact on patient quality of life, while highlighting the lack of recognition from some physicians regarding disease-specific symptoms, which can affect decision-making in condition management.
“(ePRO) systems, such as those using online surveys, mobile applications, or automated telephone interfaces, have proven feasible for identifying symptoms that can be treated by clinicians,” the study authors wrote. “For instance, in patients with cancer, ePRO monitoring enhances physical function, improves symptom management, reduces hospitalizations, and improves overall survival in those receiving cancer treatment. However, clinical research in cardiovascular care has revealed more heterogeneous outcomes, highlighting the necessity for a more dedicated system to improve physician-patient communication.”1
In the first phase of the trial, the authors set out to determine the optimal PRO implementation strategy in patients with cardiovascular disease through the development of an ePRO monitoring system using qualitative methods. The ePRO system was designed at a single outpatient center and included input from patients and physicians.
The ePRO system involved the use of the reliable and proven disease-specific questionnaires for cardiovascular disease: the 12 question Kansas City Cardiomyopathy Questionnaire (KCCQ-12), Atrial Fibrillation Effect on Quality-of-Life Questionnaire (AFEQT), or the Seattle Angina Questionnaire (SAQ). These surveys quantify the respective effects of heart failure (HF), atrial fibrillation (AF), and coronary artery disease (CAD), on symptoms, function, and quality of life.
Phase 2 of the trial focused on implementing and evaluating the system in outpatient clinics in Japan. Eligibility criteria required participants to be older than 18 years of age with a clinical diagnosis of HF, AF, or CAD. Patients were randomly assigned in 1:1 ratio to either the ePRO cohort or a control cohort. The statistical analysis was based on an intention-to-treat approach.
A total of 50 patients were enrolled in the trial, of whom 48 completed the follow-up. Patients had a median age of 71.0 (62.3-75.0) years and included 28 males. Among patients in the trial, 56.2% (n = 27) had HF, 75.0% (n = 36) had AF, and 10.4% (n = 5) had CAD. A total of 21 patients (43.8%) completed the KCCQ-12, 24 (50.0%) completed the AFEQT, and three (6.2%) completed SAQ.
Investigators found that compared to the control cohort, patients in the ePRO cohort demonstrated significant improvements in mean Patient Satisfaction Questionnaire (PSQ) score (0.16 [2.06] vs 1.61 [1.75]; P = .01) and Quality of Information score in terms of treatment (−0.12 [0.53] vs 0.35 [0.71]; P = .01). The ePRO group also showed a higher increase in the PSQ score for communication (−0.12 [0.53] vs 0.43 [0.90]; P = .01).
The study authors concluded that ePRO systems offer a meaningful improvement in communication between patients and physicians while also improving the clarity of physician explanations regarding treatment, which ultimately support patient-centered care.
“In this pilot trial integrating PRO monitoring into outpatient cardiovascular care, the ePRO monitoring system, developed with extensive multidisciplinary feedback, indicated feasibility in cardiovascular practice,” the study authors concluded. “Furthermore, ePRO monitoring enhanced patient-physician communication and clarity of physicians’ explanations of treatment as well as increased patient knowledge regarding their cardiac conditions. A user-friendly ePRO monitoring system can reduce patient uncertainty regarding disease management and promote patient-centered cardiovascular care.”1
References
1. Yamashita S, Katsumata Y, Kohsaka S, et al. Electronic Patient-Reported Outcome System Implementation in Outpatient Cardiovascular Care: A Randomized Clinical Trial. JAMA Netw Open. 2025;8(1):e2454084. doi:10.1001/jamanetworkopen.2024.54084
2. Study of usefulness of ePRO in cardiovascular disease. UMIN-CTR Clinical Trial. Updated October 20, 2023. Accessed January 15, 2025. https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056073