Matchar David B, Jacobson Alan K, Edson Robert G, Lavori Philip W, Ansell Jack E, Ezekowitz Michael D, Rickles Frederick, Fiore Lou, Boardman Kathy, Phibbs Ciaran, Fihn Stephan D, Vertrees Julia E, Dolor Rowena
Health Services Research Field Program, Duke University Medical Center, Center for Clinical Health Policy Research, VA Medical Center, 2200 W Main St, Suite 220, Durham, NC, 27705, USA.
J Thromb Thrombolysis. 2005 Jun;19(3):163-72. doi: 10.1007/s11239-005-1452-0.
Anticoagulation (AC) with warfarin reduces the risk of thromboembolism (TE) in a variety of applications, yet despite compelling evidence of the value and importance of high quality AC, warfarin remains underused, and dosing is often suboptimal. Approaches to improve AC quality include (1) an AC service (ACS), which allows the physician to delegate day-to-day details of AC management to another provider dedicated to AC care, and (2) incorporating into the treatment plan patient self-testing (PST) under which, after completing a training program, patients perform their own blood testing (typically, using a finger-stick blood analyzer), have dosage adjustments guided by a standard protocol, and forward test results, dosing and other information to the provider. Studies have suggested that PST can improve the quality of AC and perhaps lower TE and bleed rates. The purpose of Department of Veterans Affairs (VA) Cooperative Studies Program (CSP) #481, "The Home INR Study" (THINRS) is to compare AC management with frequent PST using a home monitoring device to high quality AC management (HQACM) implemented by an ACS with conventional monitoring of prothrombin time by international normalized ratio (INR) on major health outcomes. PST in THINRS involves use of an INR monitoring device that is FDA approved for home use.
Sites are VA Medical Centers where the ACS has an active roster of more than 400 patients. THINRS includes patients with atrial fibrillation (AF) and/or mechanical heart valve (MHV) expected to be anticoagulated indefinitely. THINRS has two parts. In Part 1, candidates for PST are evaluated for 2 to 4 weeks for their ability to use home monitoring devices. In Part 2, individuals capable of performing PST are randomized to (1) HQACM with testing every 4 weeks and as indicated for out of range values, medication/clinical changes, or (2) PST with testing every week and as indicated for out of range values, medication/clinical changes. The primary outcome measure is event rates, defined as the percent of patients who have a stroke, major bleed, or die. Secondary outcomes include total time in range (TTR), other events (myocardial infarction (MI), non-stroke TE, minor bleeds), competence and compliance with PST, satisfaction with AC, AC associated quality of life (QOL), and cost-effectiveness. To assess the effect of PST frequency on TTR and other outcomes, at selected sites patients randomized to perform PST are assigned one of three test frequencies (weekly, twice weekly, or once every four weeks).
华法林抗凝治疗（AC）在多种应用中可降低血栓栓塞（TE）风险，然而，尽管有确凿证据表明高质量AC的价值和重要性，但华法林仍未得到充分利用，且剂量通常不理想。提高AC质量的方法包括：（1）抗凝治疗服务（ACS），即医生可将AC管理的日常细节委托给另一位专门负责AC护理的提供者；（2）将患者自我检测（PST）纳入治疗计划，患者在完成培训计划后，自行进行血液检测（通常使用指尖采血分析仪），根据标准方案调整剂量，并将检测结果、剂量及其他信息反馈给提供者。研究表明，PST可提高AC质量，可能降低TE和出血发生率。退伍军人事务部（VA）合作研究项目（CSP）#481“家庭国际标准化比值（INR）研究”（THINRS）的目的是比较使用家庭监测设备进行频繁PST的AC管理与由ACS实施的高质量AC管理（HQACM），后者通过国际标准化比值（INR）常规监测凝血酶原时间，观察主要健康结局。THINRS中的PST涉及使用经美国食品药品监督管理局（FDA）批准可在家使用的INR监测设备。
研究地点为ACS有400多名活跃患者名单的VA医疗中心。THINRS纳入预计需长期抗凝治疗的心房颤动（AF）和/或机械心脏瓣膜（MHV）患者。THINRS分为两部分。在第1部分，对PST候选人进行2至4周的评估，以确定其使用家庭监测设备的能力。在第2部分，能够进行PST的个体被随机分为：（1）HQACM组，每4周检测一次，根据超出范围的值、药物/临床变化情况进行检测；（2）PST组，每周检测一次，根据超出范围的值、药物/临床变化情况进行检测。主要结局指标为事件发生率，定义为发生中风、大出血或死亡的患者百分比。次要结局包括在目标范围内的总时间（TTR）、其他事件（心肌梗死（MI）、非中风性TE、小出血）、PST的能力和依从性、对AC的满意度、AC相关的生活质量（QOL）以及成本效益。为评估PST频率对TTR和其他结局的影响，在选定地点，将随机分配进行PST的患者分为三种检测频率之一（每周一次、每周两次或每四周一次）。
