Summary. The demand for anticoagulation management is increasing because of a widening of the indications of treatment. A primary care clinic using near-patient testing and computer decision support software is one model of care to meet this increased demand. The study aimed to determine the cost and cost-effectiveness of primary carebased anticoagulation management in comparison with traditional' hospital care-based provision by means of a cost-effectiveness analysis using data from a Birminghambased multicentre randomized controlled trial. The costs per patient per year in primary care were £170 [95% confidence interval (CI) £149±190] vs. £69 (95% CI £57±81). Sensitivity analysis demonstrated that the cost in primary care could be reduced to under £100 per patient per year under plausible changes in the variables. Primary care provides similar levels of control to secondary care for patients on anticoagulation therapy. There is an increased cost of managing patients in primary care and at no point did primary care become a lower cost option than secondary care. Local decision-makers need to assess the increased cost of primary care anticoagulation management in terms of the potential reductions in high-cost serious adverse events.Keywords: economic evaluation, anticoagulation, warfarin, primary care, secondary care.The continuing expansion of clinical indications for warfarin (particularly non-rheumatic atrial fibrillation) has greatly increased the pressure on hospital anticoagulation management services (Sudlow et al, 1995;Sweeney et al, 1995). In response, various efforts have been undertaken to provide care in non-hospital settings. Studies have demonstrated that care within non-hospital settings can be at least as good as hospital care in terms of International Normalized Ratio (INR) control and the incidence of adverse events (Pell et al, 1993;Radley, 1995;Fitzmaurice et al, 1997). There has been little research, however, into the cost implications of devolving anticoagulation care into the community. This paper provides a report of an economic evaluation of one new model of care: a practice nurse-led, primary care clinic utilizing nearpatient testing for INR testing combined with a computerized decision support system to assist with warfarin dosing (hereafter primary care) which was compared with conventional hospital management.
METHODSThe economic evaluation used data from a Birminghambased multicentre randomized controlled trial which is reported in full elsewhere (Fitzmaurice et al, 2000). Patients were randomized either to the primary care intervention arm or to the hospital control arm. The clinical study was powered to detect a 20% difference in INR control at 5% significance, and analysis was on an intention-to-treat basis. For the economic evaluation power calculation, a £25 difference in the cost per patient per annum was taken to be a significant cost difference, which at 80% power and 5% significance required 63 patients in each arm of the trial. Effectiveness was measured by the proportion ...