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Meta-analysis: Effect of Patient Self-testing and Self-management of Long-Term Anticoagulation on Major Clinical Outcomes

Hanna E. Bloomfield, MD, MPH; Ange Krause, MD; Nancy Greer, PhD; Brent C. Taylor, PhD, MPH; Roderick MacDonald, MS; Indulis Rutks, BS; Preetham Reddy, MD; and Timothy J. Wilt, MD, MPH
[+] Article and Author Information

From the U.S. Department of Veterans Affairs' Evidence-based Synthesis Program at the Center for Chronic Disease Outcomes Research, Minneapolis Veterans Affairs Health Care System, and University of Minnesota School of Medicine, Minneapolis, Minnesota.


Disclaimer: The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the U.S. Department of Veterans Affairs or the U.S. government.

Acknowledgment: The authors thank Technical Expert Panel members Rowena Dolor, MD, MHS; Adam Rose, MD, MSc; and Keith Trettin, RPh, MBA, for assistance with developing the evidence synthesis report. They also thank Emily Hagel, MS, for preparing the study quality figure.

Grant Support: The U.S. Department of Veterans Affairs Health Services Research and Development Service.

Potential Conflicts of Interest: Drs. Bloomfield, Greer, Taylor, Reddy, and Wilt and Mr. Rutks: Grant (money to institution): U.S. Department of Veterans Affairs Health Services Research and Development Service. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M10-2099.

Requests for Single Reprints: Hanna E. Bloomfield, MD, MPH, Minneapolis Veterans Affairs Health Care System, One Veterans Drive, Mail Code 152/2E, Minneapolis, MN 55417; e-mail, hanna.bloomfield@va.gov.

Current Author Addresses: Drs. Bloomfield, Krause, Greer, Taylor, Reddy, and Wilt; Mr. MacDonald; and Mr. Rutks: Minneapolis Veterans Affairs Health Care System, One Veterans Drive, Mail Code 152/2E, Minneapolis, MN 55417.

Author Contributions: Conception and design: H.E. Bloomfield, T.J. Wilt.

Analysis and interpretation of the data: H.E. Bloomfield, A. Krause, B.C. Taylor, R. MacDonald, P. Reddy, T.J. Wilt.

Drafting of the article: H.E. Bloomfield, R. MacDonald.

Critical revision of the article for important intellectual content: B.C. Taylor, T.J. Wilt.

Final approval of the article: H.E. Bloomfield, N. Greer, B.C. Taylor, R. MacDonald, P. Reddy.

Provision of study materials or patients: I. Rutks.

Statistical expertise: B.C. Taylor, R. MacDonald, T.J. Wilt.

Obtaining of funding: T.J. Wilt.

Administrative, technical, or logistic support: N. Greer, R. MacDonald, T.J. Wilt.

Collection and assembly of data: A. Krause, N. Greer, R. MacDonald, I. Rutks, P. Reddy.


Ann Intern Med. 2011;154(7):472-482. doi:10.7326/0003-4819-154-7-201104050-00005
Text Size: A A A

Background: Anticoagulation with vitamin K antagonists reduces major thromboembolic complications in at-risk patients. With portable monitoring devices, patients can conduct their own international normalized ratio testing and dose adjustment at home.

Purpose: To determine whether patient self-testing (PST), alone or in combination with self-adjustment of doses (patient self-management [PSM]), is associated with a reduction in thromboembolic complications and all-cause mortality without an increase in major bleeding events compared with usual care.

Data Sources: MEDLINE and the Cochrane Central Register of Controlled Trials.

Study Selection: Studies published in English from 1966 to October 2010 that enrolled outpatient adults receiving long-term (>3 months) oral anticoagulant therapy and that compared PST or PSM with care in a physician's office or an anticoagulation clinic were included.

Data Extraction: Two investigators reviewed each article. Three investigators extracted data from articles that met inclusion criteria by using standardized data abstraction forms. Studies were assessed for quality, and the overall strength of evidence was rated for each clinical outcome.

Data Synthesis: Twenty-two trials, with a total of 8413 patients, were included. In one half of the trials, fewer than 50% of potentially eligible persons successfully completed the training and agreed to be randomly assigned. Patients randomly assigned to PST or PSM had lower total mortality (Peto odds ratio [OR], 0.74 [95% CI, 0.63 to 0.87]), lower risk for major thromboembolism (Peto OR, 0.58 [CI, 0.45 to 0.75]), and no increased risk for a major bleeding event (Peto OR, 0.89 [CI, 0.75 to 1.05]). The strength of evidence was moderate for the bleeding and thromboembolism outcomes but low for mortality. Eight of 11 trials reported that patient satisfaction, quality of life, or both was better with PST or PSM than with usual care.

Limitations: In one half of the trials, fewer than 50% of the potentially eligible patients were randomly assigned. Only 5 trials were considered high quality, and only 2 were conducted in the United States. No studies addressed whether PST or PSM is safe during the high-risk initiation phase.

Conclusion: Compared with usual care, PST with or without PSM is associated with significantly fewer deaths and thromboembolic events, without increased risk for a serious bleeding event, for a highly selected group of motivated adult patients requiring long-term anticoagulation with vitamin K antagonists. Whether this care model is cost-effective and can be implemented successfully in typical U.S. health care settings requires further study.

Primary Funding Source: U.S. Department of Veterans Affairs Health Services Research and Development Service.

Figures

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Figure 1.
Summary of evidence search and selection.
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Appendix Figure.
Risk for bias.

ITT = intention-to-treat.

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Figure 2.
Major thromboembolic events in PST or PSM versus usual care studies.

PSM = patient self-management; PST = patient self-testing.

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Figure 3.
Major bleeding events in PST or PSM versus usual care studies.

PSM = patient self-management; PST = patient self-testing.

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Figure 4.
All-cause mortality in PST or PSM versus usual care studies.

PSM = patient self-management; PST = patient self-testing.

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Comments

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Patient self-testing and self-management are two different interventions
Posted on May 2, 2011
Andrea Siebenhofer
Institute of General Practice
Conflict of Interest: None Declared

TO THE EDITOR It was with great interest that we read the recent paper by Bloomfield and colleagues (1). Having recently conducted a trial on the same subject (2), we feel that some issues require further clarification. As patient self-testing (PST) and patient self-management (PSM) are very different, variations in the effectiveness of the two interventions deserve special attention. This is because PST enables patients only to monitor international normalized ratio (INR) values, while PSM empowers patients to take action in achieving better anticoagulation control. Figuratively speaking, self-testing, in contrast to self-management, is like being a co-driver just watching the speedometer instead of being in the driver's seat yourself. It would therefore be very helpful to readers if the results of sensitivity and corresponding subgroup analyses were published, not least because statistically significant interactions between PST and PSM were also found.

In addition, it is misleading that the endpoint "major thromboembolic events", chosen by the authors themselves from the recent Veteran Affairs (VA) study (3), only considers strokes for analysis (33 and 31 in the self -testing and clinic-testing group respectively), while other nonstroke thrombotic events which also meet the inclusion criteria (38 and 52 nonstroke thrombotic events in the self-testing and clinic-testing group respectively) were not taken into account.

In our own trial in patients aged 60 or more, over 40% of eligible patients were willing to perform self-management, and only 8% of these stopped after successfully completing the training course (2). We interpreted both results as a great success for our treatment option. Therefore, we are convinced that after a thorough selection of eligible patients and the completion of a structured training course, self- management is a valuable option, not only for elderly patients but also for a larger number of younger patients.

We agree with Bloomfield and colleagues that it is important to have evidence of the effectiveness of a complex, multi-component intervention like PST or PSM in a typical U.S. healthcare setting. However, VA provides substantially better quality of care than other U.S. settings (4,5), so the results of the VA study (3) cannot provide conclusive evidence for a typical U.S. setting. To facilitate the implementation of this highly effective patient empowerment intervention in the U.S., a large, high- quality study on patients carrying out not only self-testing but also self -management is urgently needed in a representative U.S. setting.

Andrea Siebenhofer, MD Siebenhofer@allgemeinmedizin.uni-frankfurt.de Institute for General Practice, Goethe University Frankfurt, 60590 Frankfurt am Main, Germany

Klaus Jeitler, MD klaus.jeitler@medunigraz.at Institute for Medical Informatics, Statistics and Documentation, Medical University of Graz, Austria

Ivo Rakovac, PhD Ivo.rakovac@joanneum.at Institute for Biomedicine and Health Sciences, JOANNEUM RESEARCH Forschungsgesellschaft mbH, 8010 Graz, Austria

References

1. Bloomfield HE, Krause A, Greer N, Taylor BC, Macdonald R, Rutks I, et al. Meta-analysis: Effect of Patient Self-testing and Self-management of Long-Term Anticoagulation on Major Clinical Outcomes. Ann. Intern. Med. 2011; 154(7):472-482. [PMID: 21464349]

2. Siebenhofer A, Rakovac I, Kleespies C, Piso B, Didjurgeit U. Self- management of oral anticoagulation reduces major outcomes in the elderly. A randomized controlled trial. Thromb. Haemost. 2008;100(6):1089-1098. [PMID: 19132235]

3. Matchar DB, Jacobson A, Dolor R, Edson R, Uyeda L, Phibbs CS, et al. Effect of home testing of international normalized ratio on clinical events. N. Engl. J. Med. 2010;363(17):1608-1620. [PMID: 20961244]

4. Trivedi AN, Matula S, Miake-Lye I, Glassman PA, Shekelle P, Asch S. Systematic review: comparison of the quality of medical care in Veterans Affairs and non-Veterans Affairs settings. Med Care. 2011;49(1):76-88. [PMID: 20966778]

5. Asch SM, McGlynn EA, Hogan MM, Hayward RA, Shekelle P, Rubenstein L, et al. Comparison of Quality of Care for Patients in the Veterans Health Administration and Patients in a National Sample. Annals of Internal Medicine. 2004;141(12):938 -945. [PMID: 15611491]

Conflict of Interest:

None declared

Meta-analysis: Effect of Patient Self-testing and Self-management of Long-Term Anticoagulation on Major Clinical Outcomes
Posted on May 13, 2011
Hanna E. Bloomfield
Mineapolis VA Medical Center
Conflict of Interest: None Declared

To the Editor:

We thank Dr. Siebenhofer and her colleagues for their interest in our article (1). The subgroup analysis for thromboembolism comparing patient self testing (PST) to patient self management (PSM) indicated a significant interaction (PST: Peto OR 0.84, 0.6 to 1.1, PSM: Peto OR 0.43, 0.3 to 0.6, P=0.004). However, since this was one of many post-hoc subgroup analyses, results should be interpreted cautiously. With regard to our outcome "major thromboembolic events" it is true that for the VA trial (2) we only included strokes even though our definition (ref 1, p. 474) also included deep vein thrombosis, pulmonary embolism and arterial embolism. We took this approach because the published VA data categorized endpoints as strokes or as "non-stroke thrombotic events" which also included transient ischemic attacks (2). Nevertheless, Siebenhofer at al. raise a valid point, so we re-analyzed the data for the thromboembolic outcome (presented in the original article in figure 2) including both the strokes and the "non-stroke thrombotic events" reported in the VA trial. This did not substantively change our findings (Peto OR 0.62, 95% CI 0.49 to 0.77 vs. originally reported Peto OR 0.58, 95% CI 0.45 to 0.75). Finally, we agree with Siebenhofer et al. that self management of chronic anticoagulation is a viable option for carefully selected patients and that a large outcome trial in the US focusing on patient self management would fill a gap in the evidence base for this promising, patient-centered approach to a common problem.

References

1. Bloomfield HE, Krause A, Greer N et al. Meta-analysis: Effect of patient self-testing and self-management of long-term anticoagulation on major clinical outcomes, Ann Intern Med 2011;154(7):472-482.

2. Matchar DB, Jacobson A, Dolor R, et al. Effect of home testing of international normalized ratio on clinical events, NEJM 2010;363(17):1608- 20.

Conflict of Interest:

None declared

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