SummaryBackground Uptake of self-testing and self-management of oral anticoagulation has remained inconsistent, despite good evidence of their eff ectiveness. To clarify the value of self-monitoring of oral anticoagulation, we did a metaanalysis of individual patient data addressing several important gaps in the evidence, including an estimate of the eff ect on time to death, fi rst major haemorrhage, and thromboembolism.
From the standpoint of cost effectiveness, treatment of acute ischaemic stroke with intravenous t-PA is an economically attractive strategy.
ResearchL ong-term oral anticoagulation therapy with vitamin K antagonists is prescribed as prophylaxis against strokes and other embolic events in patients with atrial fibrillation or a mechanical heart valve. 1,2 Warfarin therapy, however, is complicated by the variability of its biologic effect, its narrow therapeutic index, and the associated thrombotic or hemorrhagic events in the event of over-or underanticoagulation. 2 It has been shown that improved anticoagulant control can be achieved through frequent monitoring of the international normalized ratio (INR), resulting in improved health outcomes. 3 Monitoring the INR and managing warfarin dosing by a primary care physician is the current clinical standard of practice in Canada. 4 Physician management requires patients to visit a laboratory regularly for INR testing. The laboratory reports the INR to the physician, who subsequently contacts the patient with any required change in dosage. An alternative strategy is patient self-management. Self-management entails the measurement of the INR by the patient using a pointof-care device and, when necessary, self-adjustment of the warfarin dose using a nomogram. 4 Several published trials have compared self-management with physician management or management in an anticoagulation clinic. 4-13 It has been found that patients who self-manage check their INR more frequently and are able to maintain a greater proportion of INRs within the therapeutic range compared with those whose therapy is monitored by a physician or in an anticoagulation clinic. [11][12][13] The results of a recent meta-analysis showed a significant reduction in thromboembolic events (odds ratio [OR] 0.45), major hemorrhagic events (OR 0.65) and all-cause mortality (OR 0.61) for those using a self-management or self-test strategy. 14 The results also showed that self-management compared with self-testing alone reduces the occurrence of thromboembolic events (OR 0.27) and death (OR 0.37). 14 These results, together with the greater initial costs of educating patients to self-manage and of the pointof-care device itself, provide the impetus for a formal costeffectiveness analysis.The objective of this study was to evaluate the incremental cost and health benefits of self-managed versus physicianmanaged chronic oral anticoagulation therapy from the perspective of the Canadian health care payer. A Bayesian approach was adopted to facilitate the incorporation of prior knowledge of transition probabilities and for probabilistic sensitivity analysis. Cost-effectiveness of self-managed versus physician-managed oral anticoagulation therapy Background: Patient self-management of long-term oral anticoagulation therapy is an effective strategy in a number of clinical situations, but it is currently not a funded option in the Canadian health care system. We sought to compare the incremental cost and health benefits of self-management with those of physician management from the perspective of the Canadian health care payer over a 5-year period.
Self-testing and adjusting of warfarin dosages by patients is an evolving strategy for management of oral anticoagulation. We performed this open, prospective, 3-month pilot study to assess the feasibility of conducting a large, randomized trial comparing self-managed with physician-managed anticoagulation. Ten competent patients with planned anticoagulation for at least 3 months were provided education on warfarin therapy and trained to use an individualized warfarin nomogram. International normalized ratios (INRs) were determined weekly for 12 weeks and reported with warfarin dosages to the investigator for the first 8 weeks only. Eight patients elected to use a home monitor (ProTime) to measure INRs. Patients maintained 76.5% (range 50-91.7%) of INRs within the target range. In 119 dosage adjustment decisions, there were only 3 errors (2.5%). No bleeding or thrombotic complications occurred. To confirm concordance, initial and final INRs were measured concurrently by the ProTime monitor and laboratory. The mean absolute difference for 16 paired INR determinations was 0.33 (range 0.02-0.9). All patients expressed satisfaction and a desire to continue with self-management. This pilot study provides support for conducting a prospective, large-scale, randomized trial.
Amiodarone-induced pulmonary toxicity (AIPT) is one of the most serious adverse effects of amiodarone therapy and can be fatal. Therefore, vigilant monitoring is advised. Baseline chest radiograph and pulmonary function tests and follow-up chest films at 3-month intervals are advocated. However, since abnormalities on these two examinations do not always precede symptoms, patient self-reports of respiratory symptoms appear to be the best method for early detection of AIPT.
Patients using anticoagulation point-of-care (POC) monitors are advised to periodically test these systems against laboratory methods to monitor performance. The international normalized ratio (INR), however, can vary between test systems owing to different instrument-reagent combinations. In a randomized study evaluating warfarin self-management, we compared INR measured by patients on a POC monitor (ProTime, International Technidyne Corporation, Edison, NJ) with those obtained at a hospital laboratory within 1 hour Ninety-one paired INR determinations from 55 patients met inclusion criteria. Clinical agreement in which POC and laboratory INR were within or outside the target INR range occurred in 56 (62%) of 91 cases (kappa = 0.35). The mean (SD) difference between POC and laboratory INR was 0.44 (0.61). Six pairs differed by 1 or more INR units, 3 at study initiation resulting in POC monitor replacement. The accuracy of INR self-testing with ProTime was acceptable. The small failure rate of INR agreement might be clinically important, suggesting the need for external quality control systems.
Patients using anticoagulation point-of-care (POC) monitors are advised to periodically test these systems against laboratory methods to monitor performance. The international normalized ratio (INR), however, can vary between test systems owing to different instrument-reagent combinations. In a randomized study evaluating warfarin self-management, we compared INR measured by patients on a POC monitor (ProTime, International Technidyne Corporation, Edison, NJ) with those obtained at a hospital laboratory within 1 hour Ninety-one paired INR determinations from 55 patients met inclusion criteria. Clinical agreement in which POC and laboratory INR were within or outside the target INR range occurred in 56 (62%) of 91 cases (kappa = 0.35). The mean (SD) difference between POC and laboratory INR was 0.44 (0.61). Six pairs differed by 1 or more INR units, 3 at study initiation resulting in POC monitor replacement. The accuracy of INR self-testing with ProTime was acceptable. The small failure rate of INR agreement might be clinically important, suggesting the need for external quality control systems.
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