Bárbara Menéndez-Jándula, MD; Juan Carlos Souto, MD, PhD; Arturo Oliver, MD; Isabel Montserrat, MD; Mireia Quintana, RN; Ignasi Gich, MD, PhD; Xavier Bonfill, MD, PhD; Jordi Fontcuberta, MD, PhD
Trial EC/00/111/1439 HSCSP.
Acknowledgments: The authors thank Montserrat Boltes for her administrative work throughout the study, Nuria Plaza and Anna Serra from Roche Diagnostics for logistic support, and Professor William Stone for his help with the manuscript.
Grant Support: In part by Roche Diagnostic S.L.
Potential Financial Conflicts of Interest: None disclosed.
Requests for Single Reprints: Juan Carlos Souto, MD, PhD, Unitat d'Hemostàsia i Trombosi, Hospital de la Santa Creu i Sant Pau, Sant Antoni Maria Claret 167, 08025 Barcelona, Spain; e-mail, firstname.lastname@example.org.
Current Author Addresses: Drs. Menéndez-Jándula, Souto, Montserrat, and Fontcuberta and Ms. Quintana: Unitat d'Hemostàsia i Trombosi. Hospital de la Santa Creu i Sant Pau, Sant Antoni Maria Claret 167, 08025 Barcelona, Spain.
Dr. Oliver: Fundació Puigvert, Cartagena 340, 08025 Barcelona, Spain.
Drs. Gich and Bonfill: Servei d'Epidemiologia i Salut Publica, Hospital de la Santa Creu i Sant Pau, Sant Antoni Maria Claret 167, 08025 Barcelona, Spain.
Author Contributions: Conception and design: B. Menéndez-Jándula, J.C. Souto, A. Oliver, I. Montserrat, I. Gich, X. Bonfill, J. Fontcuberta.
Analysis and interpretation of the data: B. Menéndez-Jándula, J.C. Souto, A. Oliver, I. Montserrat, I. Gich, J. Fontcuberta.
Drafting of the article: B. Menéndez-Jándula, J.C. Souto.
Critical revision of the article for important intellectual content: I. Gich, X. Bonfill, J. Fontcuberta.
Final approval of the article: B. Menéndez-Jándula, J.C. Souto, A. Oliver, I. Montserrat, M. Quintana, I. Gich, X. Bonfill, J. Fontcuberta.
Provision of study materials or patients: B. Menéndez-Jándula, I. Montserrat, M. Quintana.
Statistical expertise: A. Oliver, I. Gich.
Obtaining of funding: J.C. Souto, J. Fontcuberta.
Administrative, technical, or logistic support: M. Quintana, I. Gich, X. Bonfill.
Collection and assembly of data: B. Menéndez-Jándula, I. Montserrat, M. Quintana.
Control of oral anticoagulant treatment has been reported to be suboptimal, but previous studies suggest that patient self-management improves control.
To compare the quality of control and the clinical outcomes of oral anticoagulant treatment in self-managed patients versus patients following conventional management.
Randomized, controlled trial.
University-affiliated hospital in Spain.
737 patients with indications for anticoagulant treatment.
The self-management group (n = 368) received simple instructions for using a portable coagulometer weekly and self-adjusting treatment dose. The conventional management group (n = 369) received usual care in an anticoagulation clinic (monthly measurement and control of international normalized ratio [INR], managed by hematologists).
Percentage of INR values within the target range and major related complications.
The median follow-up period was 11.8 months (range, 0.3 to 16.9 months). The unadjusted percentages of in-range INRs were 58.6% in the self-management group and 55.6% in the conventional management group (difference, 3.0 percentage points [95% CI, 0.4 to 5.4 percentage points]). Twenty-seven patients (7.3%) in the conventional management group and 8 (2.2%) in the self-management group had major complications related to anticoagulant treatment. The unadjusted risk difference for major complications between groups was 5.1 percentage points (exact 95% CI, 1.7 to 8.5 percentage points). Fewer patients had minor hemorrhages in the self-management group (14.9%) than in the conventional management group (36.4%). Fifteen patients (4.1%) in the conventional management group and 6 (1.6%) in the self-management group died (unadjusted risk difference, 2.5 percentage points [exact 95% CI, 0.0 to 5.1 percentage points]).
The trial was performed at only 1 center and was not blinded. The dropout rate in the intervention group was 21%.
Compared with conventional management by an anticoagulation clinic, self-management of oral anticoagulant treatment achieved a similar level of control. Of note, major complications and minor hemorrhages were less common in the self-management group.
Bárbara Menéndez-Jándula, Juan Carlos Souto, Arturo Oliver, Isabel Montserrat, Mireia Quintana, Ignasi Gich, et al. Comparing Self-Management of Oral Anticoagulant Therapy with Clinic Management: A Randomized Trial. Ann Intern Med. 2005;142:1–10. doi: 10.7326/0003-4819-142-1-200501040-00006
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Published: Ann Intern Med. 2005;142(1):1-10.
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