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Transforming oral anticoagulation by combining international normalized ratio (INR) self testing and online automated management

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Abstract

Because of the number and complexity of issues addressed, this manuscript is divided into two major sections. The first section focuses on how new technology can transform vitamin K antagonist therapy. Specifically, evidence suggest that combining INR self testing with online automated management (STOAM) can greatly reduce the time, expense, and hassle of managing VKA therapy; improve the quality of INR control to a degree that, in large studies, has been associated with a 50% or more reduction in major events (such as stroke, myocardial infarction, major hemorrhage, and death); reduce health care costs by an estimated $4 million per 1,000 patients per year; and improve quality of life and patient satisfaction. Such improved VKA therapy should be safer, more effective, and more cost-effective than the new oral anticoagulants. The improved efficiency and outcomes also should prompt reconsideration of indications in which VKA therapy may not be the current standard of care. Although new reimbursement models are clearly needed for STOAM, the current Medicare reimbursement model for patient self testing can be utilized to make VKA management financially viable and sustainable. The second section of this article focuses on additional considerations that may be important in optimizing VKA therapy and/or selecting an online management system. A brief review is provided to examine why a recent meta analysis and a large randomized trial of self testing did not find the same degree of improvement as reported in the four STOAM trials described in the first section of this article.

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Potential conflicts of interest

Consultant to Genesis Advanced Technologies, Inc. in development of the ClotFree system, Research support from Roche Diagnostics, Inc., Advisory board member for Boehringer-Ingelheim and Daiichi-Sankyo, minor share holder of Alere, Inc.

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Correspondence to Henry I. Bussey.

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Dr. Bussey is currently serving a three-year term as the “GSK Distinguished Scholar in Thrombosis” which was awarded in late 2008 by the Chest Foundation of the American College of Chest Physicians for his proposal to develop and test a system for self-testing with online automated management, ClotFree.

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Bussey, H.I. Transforming oral anticoagulation by combining international normalized ratio (INR) self testing and online automated management. J Thromb Thrombolysis 31, 265–274 (2011). https://doi.org/10.1007/s11239-011-0564-y

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