Intervention Review

Self-monitoring and self-management of oral anticoagulation

  1. Josep M Garcia-Alamino1,
  2. Alison M Ward1,
  3. Pablo Alonso-Coello2,
  4. Rafael Perera3,
  5. Clare Bankhead1,
  6. David Fitzmaurice4,
  7. Carl J Heneghan3,*

Editorial Group: Cochrane Heart Group

Published Online: 14 APR 2010

Assessed as up-to-date: 1 MAY 2008

DOI: 10.1002/14651858.CD003839.pub2

Database Title

Additional Information

How to Cite

Garcia-Alamino JM, Ward AM, Alonso-Coello P, Perera R, Bankhead C, Fitzmaurice D, Heneghan CJ. Self-monitoring and self-management of oral anticoagulation. Cochrane Database of Systematic Reviews 2010, Issue 4. Art. No.: CD003839. DOI: 10.1002/14651858.CD003839.pub2.

Author Information

  1. 1

    University of Oxford, Department of Primary Health Care, Oxford, UK

  2. 2

    Institute of Biomedical Research Sant Pau (IIB Sant Pau), Barcelona, Iberoamerican Cochrane Centre, Barcelona, Spain

  3. 3

    University of Oxford, Department of Primary Care Health Sciences, Oxford, UK

  4. 4

    Clinical Sciences Building, University of Birmingham, Department of Primary Care Clinical Sciences, Birmingham, UK

*Carl J Heneghan, Department of Primary Care Health Sciences, University of Oxford, 23-38 Hythe Bridge Street, Oxford, OX1 2ET, UK. Carl.heneghan@phc.ox.ac.uk.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 14 APR 2010

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Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Background

The introduction of portable monitors (point-of-care devices) for the management of patients on oral anticoagulation allows self-testing by the patient at home. Patients who self-test can either adjust their medication according to a pre-determined dose-INR schedule (self-management) or they can call a clinic to be told the appropriate dose adjustment (self-monitoring). Several trials of self-monitoring of oral anticoagulant therapy suggest this may be equal to or better than standard monitoring.

Objectives

To evaluate the effects of self-monitoring or self-management of oral anticoagulant therapy compared to standard monitoring.

Search methods

We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2007, Issue 4), MEDLINE, EMBASE and CINAHL (to November 2007). We checked bibliographies and contacted manufacturers and authors of relevant studies. No language restrictions were applied.

Selection criteria

Outcomes analysed were thromboembolic events, mortality, major haemorrhage, minor haemorrhage, tests in therapeutic range, frequency of testing, and feasibility of self-monitoring and self-management.

Data collection and analysis

The review authors independently extracted data. We used a fixed-effect model with the Mantzel-Haenzel method to calculate the pooled risk ratio (RR) and Peto’s method to verify the results for uncommon outcomes. We examined heterogeneity amongst studies with the Chi2 and I2 statistics.

Main results

We identified 18 randomized trials (4723 participants). Pooled estimates showed significant reductions in both thromboembolic events (RR 0.50, 95% CI 0.36 to 0.69) and all-cause mortality (RR 0.64, 95% CI 0.46 to 0.89). This reduction in mortality remained significant after the removal of low-quality studies (RR 0.65, 95% CI 0.46 to 0.90). Trials of self-management alone showed significant reductions in thromboembolic events (RR 0.47, 95% CI 0.31 to 0.70) and all-cause mortality (RR 0.55, 95% CI 0.36 to 0.84); self-monitoring did not (thrombotic events RR 0.57, 95% CI 0.32 to 1.00; mortality RR 0.84, 95% CI 0.50 to 1.41). Self-monitoring significantly reduced major haemorrhages (RR 0.56, 95% CI 0.35 to 0.91) whilst self-management did not (RR 1.12, 95% CI 0.78 to 1.61). Twelve trials reported improvements in the percentage of mean INR measurements in the therapeutic range. No heterogeneity was identified in any of these comparisons.

Authors' conclusions

Compared to standard monitoring, patients who self-monitor or self-manage can improve the quality of their oral anticoagulation therapy. The number of thromboembolic events and mortality were decreased without increases in harms. However, self-monitoring or self-management were not feasible for up to half of the patients requiring anticoagulant therapy. Reasons included patient refusal, exclusion by their general practitioner, and inability to complete training.

 

Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Self-monitoring and self-management of oral anticoagulation therapy

Near patient or point-of-care testing devices have made it possible for people on long-term oral anticoagulation to monitor their blood clotting time measured as the international normalized ration (INR) in the home setting. Patients who self-test can either adjust their medication dose according to a pre-determined dose-INR schedule (self-management) or they can call a clinic to be told the appropriate dose adjustment (self-monitoring). Several published studies suggest these methods of monitoring anticoagulation therapy may be equal to or better than standard monitoring by a physician.

In total, we found 18 randomized trials that compared self-monitoring and self-management with standard monitoring. The combined results of these trials showed a halving of thromboembolic events and all-cause mortality with self-monitoring and self-management and no reduction in the number of major bleeds. Self-management had similar reductions in thromboembolic events and mortality to the overall benefit, with no effect on major bleeds. Self-monitoring halved the number of major haemorrhages that occurred but did not significantly reduce the rates of thrombotic events or all-cause mortality.

In conclusion, self-monitoring or self-management can improve the quality of oral anticoagulant therapy, leading to fewer thromboembolic events and lower mortality, without a reduction in the number of major bleeds. Self-monitoring and self-management are not feasible for all patients, which requires the identification and education of suitable patients.

 

摘要

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

背景

口服抗凝血劑之自我監測與管理

針對使用口服抗凝血劑的病患管理，攜帶式監測器 (重點照護設備) 的引進讓患者能夠在家裡做自我檢測。患者做自我檢測，可根據預先確定劑量和INR (國際標準凝血時間比) 的一個時間表，來調整他們的藥物劑量 (自我管理) ；或是他們可以到門診由醫生告知適當的劑量調整 (自我監測) 。有一些口服抗凝血劑治療之自我監測的臨床試驗指出，自我監測與管理的效果可能相等於或優於標準監測。

目標

和標準監測做比較，評估口服抗凝血劑療法之自我監測與管理的效果。

搜尋策略

我們檢索了Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2007，Issue 4) 、MEDLINE、EMBASE和 CINAHL (至2007年11月) 。我們查了各參考書目，並且與相關文獻的廠商和作者聯繫。檢索時沒有作語言限制。

選擇標準

分析結果的項目包含了動脈栓塞事件、死亡率、主要及次要出血現象、治療範圍檢測、檢測頻率和自我監測及管理的可行性。

資料收集與分析

文獻回顧的作者們獨立地抽取數據資料。我們採用了MantzelHaenzel method中的固定效果模式來計算匯集的RR值；並且用了Peto's method 來驗證不尋常的結果。我們以Chi2和I2統計法檢驗了各文獻中的異質性。

主要結論

我們確定了18個隨機試驗 (4723位受試者) 。匯集的評估結果中顯示，動脈栓塞事件 (RR 0.50，95% CI 0.36 – 0.69) 和所有原因死亡率 (RR 0.64，95% CI 0.46 – 0.89) 都有顯著的減少。這個減少的死亡率在移除低品質文獻後依然有顯著差異 (RR 0.65，95% CI 0.46 – 0.90) 。單獨的自我管理試驗中顯示，動脈栓塞事件 (RR 0.47，95% CI 0.31 – 0.70) 和所有原因死亡率 (RR 0.55，95% CI 0.36 – 0.84) 也有顯著的減少；而自我監測方面則沒有顯著差異 (動脈栓塞事件的RR 0.57， 95% CI 0.32 – 1.00;死亡率RR 0.84，95% CI 0.50 – 1.41) 。自我監測顯著地降低了主要出血現象 (RR 0.56，95% CI 0.35 – 0.91) ，而自我管理方面則沒有影響 (RR 1.12，95% CI 0.78 – 1.61) 。12個試驗反映了治療範圍中平均INR測值百分比的改善情形。在任何的這些對照中皆沒有發現異質性。

作者結論

和標準監測比較，有做自我監測或管理的患者能夠改善他們的口服抗凝血劑治療品質。血栓栓塞事件數和死亡率在沒有增加壞處的情況下有下降的趨勢。然而，自我監測或管理對於正需要抗凝血劑治療的患者有半數以上是不可行的。其原因包括患者的拒絕、其家庭醫師的排除以及無法完成訓練。

翻譯人

本摘要由李宛臻翻譯。

此翻譯計畫由臺灣國家衛生研究院 (National Health Research Institutes, Taiwan) 統籌。

總結

口服抗凝血劑治療之自我監測與管理：近患者檢驗或重點照護檢驗儀器讓長期服用口服抗凝血劑的人能夠在家裡監測他們的凝血時間，以國際標準化比值 (INR) 來衡量。有做自我檢測的患者可以根據預先確定劑量和INR的一個時間表調整他們的藥物劑量 (自我管理) ，或者他們可以到門診由醫生告知適當的劑量調整 (自我監測) 。有一些已發表的文獻指出，這些監測抗凝血劑治療法的效果可能相等於或優於由醫師執行的標準監測。在全部文獻中，我們找到18個以自我監測與管理對照標準監測的隨機臨床試驗。這些試驗的綜合結果顯示：有做自我監測或管理的患者降低了一半的血栓栓塞事件數和所有原因死亡率，主要出血次數沒有減少。自我管理在血栓栓塞事件數和死亡率整體效益上有類似的減少趨勢，在主要出血上則沒有影響。自我監測降低了一半的主要出血發生次數，但都沒有顯著地降低血栓事件發生率或所有原因死亡率。在結論中，自我監測或管理能夠改善口服抗凝血劑治療的品質，而能有較低的血栓栓塞事件數和死亡率 (但沒有降低主要出血次數) 。自我監測和管理對於所有的患者皆可行，而這需要確認並教育合適的患者。

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