Background: Control of oral anticoagulant treatment has been reported to be suboptimal, but previous studies suggest that patient self-management improves control. Objective: To compare the quality of control and the ...Background: Control of oral anticoagulant treatment has been reported to be suboptimal, but previous studies suggest that patient self-management improves control. Objective: To compare the quality of control and the clinical outcomes of oral anticoagulant treatment in self-managed patients versus patients following conventional management. Design: Randomized, controlled trial. Setting: University-affiliated hospital in Spain. Patients: 737 patients with indications for anticoagulant treatment. Intervention: 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). Measurements: Percentage of INR values within the target range and major related complications. Results: 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]). Limitations: The trial was performed at only 1 center and was not blinded. The dropout rate in the intervention group was 21%. Conclusions: 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.展开更多
文摘Background: Control of oral anticoagulant treatment has been reported to be suboptimal, but previous studies suggest that patient self-management improves control. Objective: To compare the quality of control and the clinical outcomes of oral anticoagulant treatment in self-managed patients versus patients following conventional management. Design: Randomized, controlled trial. Setting: University-affiliated hospital in Spain. Patients: 737 patients with indications for anticoagulant treatment. Intervention: 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). Measurements: Percentage of INR values within the target range and major related complications. Results: 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]). Limitations: The trial was performed at only 1 center and was not blinded. The dropout rate in the intervention group was 21%. Conclusions: 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.
