Self-Monitoring and Self-Management of Anticoagulation Therapy

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 predetermined dose-International Normalized Ratio (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 with standard monitoring. Search Strategy: We searched the Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library 2007, Issue 4), Medline, EM BASE, and CINAHL (to November 2007). We checked bibliographies and contacted manufacturers and authors of relevant studies. No language restrictions were applied. Selection Criteria: Outcomes analyzed were thromboembolic events, mortality, major hemorrhage, minor hemorrhage, 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 Mantel-Haenszel method to calculate the pooled risk ratio (RR) and the Peto method to verify the results for uncommon outcomes. We examined heterogeneity amongst studies with the Chi(2) and I(2) statistics. Main Results: We identified 18 randomized trials (4,723 participants). Pooled estimates showed significant reductions in thromboembolic events (RR = 0.50; 95% confidence interval [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; 95010 CI, 0.32 to 1.00; mortality RR = 0.84; 95% CI, 0.50 to 1.41). Self-monitoring significantly reduced major hemorrhages (RR = 0.56; 95% CI, 0.35 to 0.91), whereas 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 with 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 was not feasible for up to one-half of the patients requiring anticoagulant therapy. Reasons included patient refusal, exclusion by their general practitioner, and inability to complete training.