Relationship between test frequency and outcomes of anticoagulation: A literature review and commentary with implications for the design of randomized trials of patient self-management
Relationship between test frequency and outcomes of anticoagulation: A literature review and commentary with implications for the design of randomized trials of patient self-management
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DOI：
10.1023/a:1018778914477
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发表时间：
2000-04-01
影响因子：
4
通讯作者：
Matchar, DB
中科院分区：
文献类型：
--
作者：
Samsa, GP;Matchar, DB
工作背景：抗凝治疗的患者自我管理（PSM）主要基于更频繁的检测将导致更严格的抗凝控制，从而改善临床结局的前提，是一种有前途的护理模式。本文的目标是（1）描述与更频繁的测试改善结果相关的证据强度;（2）讨论这些发现对评估PSM有效性和成本效益的随机对照试验（RCT）设计的影响。方法：我们进行了两篇文献综述：一个检查目标范围内的时间（TTR）与大出血和血栓栓塞的临床结果之间的关系的强度;第二个检查测试频率与TTR之间的关系的强度。我们发现（1）TTR和临床结局之间的关系很强，因此支持使用TTR作为主要结局变量;（2）更频繁的检测似乎会增加TTR，尽管支持后一结论的研究相对较少且不确定。统计学分析表明，以临床事件发生率为主要结果的研究规模要比以TTR为基础的可比研究规模大得多。结论：在设计PSM随机试验时，应（1）采用高质量抗凝治疗作为对照组，而不是常规治疗;（3）在干预组中包括不同的检测间隔;（4）使用TTR作为主要结局变量，事件发生率作为次要结局;（5）基于TTR绝对改善5-10%计算样本量。需要进行额外的RCT，以确定如何最好地实现PSM的承诺。
Background: Patient self-management (PSM) of anticoagulation, which is primarily based upon the premise that more frequent testing will lead to tighter anticoagulation control and thus to improved clinical outcomes, is a promising model of care. The goals of this paper are (1) to describe the strength of evidence correlating more frequent testing with improved outcomes; and (2) to discuss implications of these findings for the design of randomized controlled trials (RCTs) assessing the effectiveness and cost-effectiveness of PSM.Methods: We performed two literature reviews: one examining the strength of the relationship between time in target range (TTR) and the clinical outcomes of major bleeding and thromboembolism; and the second examining the strength of the relationship between frequency of testing and TTR.Results: We found that (1) the relationship between TTR and clinical outcomes is strong, thus supporting use of TTR as a primary outcome variable; and (2) more frequent testing seems to increase TTR, although the studies supporting this latter conclusion were relatively few and not definitive. Statistical analysis suggested that a study which uses clinical event rates as its primary outcome would need to be much larger than a comparable study which is based upon TTR.Conclusions: When designing randomized trials of PSM, the design should (1) use as its control group high quality anticoagulation management rather than usual care; (2) include the maximum possible amount of self-management in the intervention group; (3) include different testing intervals in the intervention group; (4) use TTR as the primary outcome variable and event rates as a secondary outcome; and (5) base the sample size calculations upon a 5-10% absolute improvement in TTR. Additional RCTs are needed in order to determine how the promise of PSM can best be fulfilled.