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

被引:142
作者
Samsa, GP
Matchar, DB
机构
[1] Duke Univ, Med Ctr, Ctr Clin Hlth Policy Res, Durham, NC 27705 USA
[2] Duke Univ, Med Ctr, Dept Med, Durham, NC 27705 USA
[3] Duke Univ, Med Ctr, Dept Community & Family Med, Durham, NC 27705 USA
[4] Dept Vet Affairs Med Ctr, Ctr Hlth Serv Res Primary Care, Durham, NC USA
关键词
anticoagulation; literature review; patient self-management; randomized controlled trial; secondary outcomes;
D O I
10.1023/A:1018778914477
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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.
引用
收藏
页码:283 / 292
页数:10
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