Department of Pharmacy, Fujian Maternity and Child Health Hospital College of Clinical Medicine for Obstetrics & Gynecology and Pediatrics, Fujian Medical University, Fuzhou, China.
Department of Neurosurgery, Fujian Medical University Union Hospital, fuzhou, China.
J Med Internet Res. 2024 Jul 29;26:e46319. doi: 10.2196/46319.
Poor anticoagulation management of warfarin may lead to patient admission, prolonged hospital stays, and even death due to anticoagulation-related adverse events. Traditional non-web-based outpatient clinics struggle to provide ideal anticoagulation management services for patients, and there is a need to explore a safer, more effective, and more convenient mode of warfarin management.
This study aimed to compare differences in the quality of anticoagulation management and clinical adverse events between a web-based management model (via a smartphone app) and the conventional non-web-based outpatient management model.
This study is a prospective cohort research that includes multiple national centers. Patients meeting the nadir criteria were split into a web-based management group using the Alfalfa app or a non-web-based management group with traditional outpatient management, and they were then monitored for a 6-month follow-up period to collect coagulation test results and clinical events. The effectiveness and safety of the 2 management models were assessed by the following indicators: time in therapeutic range (TTR), bleeding events, thromboembolic events, all-cause mortality events, cumulative event rates, and the distribution of the international normalized ratio (INR).
This national multicenter cohort study enrolled 522 patients between June 2019 and May 2021, with 519 (99%) patients reaching the follow-up end point, including 260 (50%) in the non-web-based management group and 259 (50%) in the web-based management group. There were no observable differences in baseline characteristics between the 2 patient groups. The web-based management group had a significantly higher TTR than the non-web-based management group (82.4% vs 71.6%, P<.001), and a higher proportion of patients received effective anticoagulation management (81.2% vs 63.5%, P<.001). The incidence of minor bleeding events in the non-web-based management group was significantly higher than that in the web-based management group (12.1% vs 6.6%, P=.048). Between the 2 groups, there was no statistically significant difference in the incidence of severe bleeding and thromboembolic and all-cause death events. In addition, compared with the non-web-based management group, the web-based management group had a lower proportion of INR in the extreme subtreatment range (17.6% vs 21.3%) and severe supertreatment range (0% vs 0.8%) and a higher proportion in the treatment range (50.4% vs 43.1%), with statistical significance.
Compared with traditional non-web-based outpatient management, web-based management via the Alfalfa app may be more beneficial because it can enhance patient anticoagulation management quality, lower the frequency of small bleeding events, and improve INR distribution.
华法林抗凝管理不善可能导致患者住院、住院时间延长,甚至因抗凝相关不良事件而死亡。传统的非网络门诊诊所难以为患者提供理想的抗凝管理服务,因此需要探索一种更安全、更有效、更方便的华法林管理模式。
本研究旨在比较基于网络的管理模式(通过智能手机应用程序)与传统的非网络门诊管理模式在抗凝管理质量和临床不良事件方面的差异。
本研究是一项前瞻性队列研究,包括多个国家中心。符合最低标准的患者被分为基于网络的管理组(使用 Alfalfa 应用程序)或非基于网络的管理组(采用传统的门诊管理),并进行为期 6 个月的随访,以收集凝血试验结果和临床事件。通过以下指标评估两种管理模式的有效性和安全性:治疗范围内时间(TTR)、出血事件、血栓栓塞事件、全因死亡率事件、累积事件发生率以及国际标准化比值(INR)分布。
这项全国多中心队列研究纳入了 2019 年 6 月至 2021 年 5 月期间的 522 名患者,其中 519 名(99%)患者达到随访终点,包括非网络管理组的 260 名(50%)患者和网络管理组的 259 名(50%)患者。两组患者的基线特征无明显差异。与非网络管理组相比,网络管理组的 TTR 显著更高(82.4%比 71.6%,P<.001),且接受有效抗凝管理的患者比例更高(81.2%比 63.5%,P<.001)。非网络管理组的轻微出血事件发生率显著高于网络管理组(12.1%比 6.6%,P=.048)。两组严重出血和血栓栓塞以及全因死亡事件的发生率无统计学差异。此外,与非网络管理组相比,网络管理组的 INR 处于极轻治疗范围的比例较低(17.6%比 21.3%),处于严重超治疗范围的比例较低(0%比 0.8%),而处于治疗范围内的比例较高(50.4%比 43.1%),差异具有统计学意义。
与传统的非网络门诊管理相比,通过 Alfalfa 应用程序进行的网络管理可能更有益,因为它可以提高患者抗凝管理质量,降低小出血事件的发生频率,并改善 INR 分布。