PDF(Pubmed)
Abstract：
BACKGROUND: 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.
OBJECTIVE: 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.
METHODS: 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).
RESULTS: 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.
CONCLUSIONS: 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.
OBJECTIVE: 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.
METHODS: 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).
RESULTS: 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.
CONCLUSIONS: 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.
摘要：
背景：华法林抗凝管理不善可能导致患者入院，住院时间延长,甚至因抗凝相关不良事件而死亡。传统的非网络门诊很难为患者提供理想的抗凝管理服务,有必要探索更安全的，更有效,更便捷的华法林管理模式。
目的：本研究旨在比较基于网络的管理模式（通过智能手机应用）和传统的非基于网络的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。
方法：本研究是一项前瞻性队列研究，包括多个国家中心。符合最低点标准的患者被分为使用Alfalfa应用程序的基于网络的管理组，或使用传统门诊管理的非基于网络的管理组，然后对他们进行为期6个月的随访,以收集凝血测试结果和临床事件.2种管理模式的有效性和安全性通过以下指标进行评估：在治疗范围内的时间（TTR），出血事件,血栓栓塞事件,全因死亡事件,累积事件发生率，以及国际标准化比率(INR)的分布。
结果：这项国家多中心队列研究在2019年6月至2021年5月期间招募了522名患者，其中519名（99％）患者达到了随访终点，包括非基于Web的管理组中的260个（50％）和基于Web的管理组中的259个（50％）。两组患者的基线特征无明显差异。基于Web的管理组的TTR明显高于非基于Web的管理组（82.4％vs71.6％，P<.001),接受有效抗凝治疗的患者比例更高(81.2%vs63.5%,P<.001)。非网络管理组轻微出血事件发生率明显高于网络管理组(12.1%vs6.6%,P=.048）。在两组之间，严重出血,血栓栓塞和全因死亡事件的发生率无统计学差异.此外,与非基于网络的管理组相比，基于网络的管理组在极端亚治疗范围（17.6％比21.3％）和严重超治疗范围（0％比0.8％）中INR的比例较低，在治疗范围中比例较高（50.4％比43.1％），具有统计学意义。
结论：与传统的非网络门诊管理相比，通过苜蓿应用程序进行基于网络的管理可能更有益，因为它可以提高患者的抗凝管理质量，降低小出血事件的频率，并改善INR分布。
目的：本研究旨在比较基于网络的管理模式（通过智能手机应用）和传统的非基于网络的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。
方法：本研究是一项前瞻性队列研究，包括多个国家中心。符合最低点标准的患者被分为使用Alfalfa应用程序的基于网络的管理组，或使用传统门诊管理的非基于网络的管理组，然后对他们进行为期6个月的随访,以收集凝血测试结果和临床事件.2种管理模式的有效性和安全性通过以下指标进行评估：在治疗范围内的时间（TTR），出血事件,血栓栓塞事件,全因死亡事件,累积事件发生率，以及国际标准化比率(INR)的分布。
结果：这项国家多中心队列研究在2019年6月至2021年5月期间招募了522名患者，其中519名（99％）患者达到了随访终点，包括非基于Web的管理组中的260个（50％）和基于Web的管理组中的259个（50％）。两组患者的基线特征无明显差异。基于Web的管理组的TTR明显高于非基于Web的管理组（82.4％vs71.6％，P<.001),接受有效抗凝治疗的患者比例更高(81.2%vs63.5%,P<.001)。非网络管理组轻微出血事件发生率明显高于网络管理组(12.1%vs6.6%,P=.048）。在两组之间，严重出血,血栓栓塞和全因死亡事件的发生率无统计学差异.此外,与非基于网络的管理组相比，基于网络的管理组在极端亚治疗范围（17.6％比21.3％）和严重超治疗范围（0％比0.8％）中INR的比例较低，在治疗范围中比例较高（50.4％比43.1％），具有统计学意义。
结论：与传统的非网络门诊管理相比，通过苜蓿应用程序进行基于网络的管理可能更有益，因为它可以提高患者的抗凝管理质量，降低小出血事件的频率，并改善INR分布。
