McCahon Deborah, Baker Jennifer M, Murray Ellen T, Fitzmaurice David A
Department of Primary Care Clinical Sciences, University of Birmingham, Birmingham, UK.
J Clin Pathol. 2016 Apr;69(4):331-6. doi: 10.1136/jclinpath-2015-203168. Epub 2015 Oct 30.
To evaluate the utility of an online self-report registry for patient self-monitoring and self-management (PSM) of warfarin therapy.
A prospective observational study of UK-based patients undertaking PSM and recording their international normalised ratio (INR) data via an online registry. Consenting participants recorded INR test dates, results and warfarin dosages using the online registry for a period of 12 months. Participants reported demographic data, disease characteristics and treatment-related adverse events and provided feedback via a survey. Data accuracy was assessed through comparison of INR results recorded online with results stored on 19 INR testing devices. Percentage time spent within therapeutic time in range (TTR) was also examined.
Eighty-seven per cent (39/45) completed the study period. Age ranged from 26 to 83 years, 44% had undertaken PSM for >5 years. Sixty-six per cent (25/38) reported that the registry was easy to navigate and use. Forty-two participants contributed a total of 1669 INR results. Agreement between self-reported INR results and source INR data was high (99%). Mean TTR was 76% (SD 18.58) with 83% having >60% TTR.
Findings suggest that an online PSM registry is feasible, accurate and acceptable to patients. These findings require confirmation in a larger cohort of PSM patients. An online self-report registry could provide a valuable resource for gathering real world evidence of clinical effectiveness and safety of these developing models of care.
评估一个在线自我报告登记系统在华法林治疗患者自我监测和自我管理（PSM）中的效用。
对英国进行PSM并通过在线登记系统记录其国际标准化比值（INR）数据的患者进行一项前瞻性观察研究。同意参与的参与者使用在线登记系统记录INR检测日期、结果和华法林剂量，为期12个月。参与者报告人口统计学数据、疾病特征和治疗相关不良事件，并通过一项调查提供反馈。通过将在线记录的INR结果与19台INR检测设备上存储的结果进行比较来评估数据准确性。还检查了处于治疗时间范围内（TTR）的时间百分比。
87%（39/45）的参与者完成了研究期。年龄范围为26至83岁，44%的人进行PSM已超过5年。66%（25/38）的人报告称该登记系统易于操作和使用。42名参与者共提供了1669个INR结果。自我报告的INR结果与原始INR数据之间的一致性很高（99%）。平均TTR为76%（标准差18.58），83%的人的TTR>60%。
研究结果表明，在线PSM登记系统对患者来说是可行、准确且可接受的。这些结果需要在更大规模的PSM患者队列中得到证实。一个在线自我报告登记系统可为收集这些新兴护理模式的临床有效性和安全性的真实世界证据提供宝贵资源。
