OBJECTIVES: To assess the clinical effectiveness of point-of-care (POC) INR monitoring devices for patient on long-term oral anticoagulation therapy (OAT). METHODS: A systematic review of the clinical literature was performed. Seventeen RCT studies published between January 1996 and November 2008 comparing POC devices to routine anticoagulation control were included in the analysis. RESULTS: Of the 17 studies included in the analysis, 15 studies compared patient self-management or self-testing to routine anticoagulation control and 2 studies examined the use of POC devices by primary health care practitioners. There was variation among the studies regarding observation periods, indication for OAT and overall study quality. Based on pooled analyses, there was no significant difference in major hemorrhagic events between patients in POC monitoring groups and usual care controls (OR 0.77, 95% CI 0.54, 1.10). POC monitoring resulted in significantly fewer thromboembolic events (OR 0.56, 95% CI 0.39, 0.80) and deaths (OR 0.63, 95% CI 0.41, 0.97) compared with usual care. Subgroup analyses included POC strategy, control strategy, indication for OAT, study quality, length of follow-up and industry sponsored. Mean time in the therapeutic range was pooled across studies and weighted by the number of patient-years of observation to assess INR control. The POC monitoring patients were in range 68.6% of the time compared with 64.3% of time in usual care controls. Data were deemed unreliable to estimate 95% CI for pooled estimates. Higher testing frequency and more intensive patient education in the POC monitoring groups may also partially explain observed differences in clinical outcomes. CONCLUSIONS: The review of clinical evidence suggest that using POC monitoring devices for patients on long-term OAT results in significantly fewer deaths and thromboembolic events and may result in better INR control than conventional laboratory testing. Nevertheless, the use of POC devices should factor patient suitability, health system constraints and affordability.