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ePaper created 2014-10-06, 13:17:01 | version 1.33.00
patients studied in Europe. This population was analyzed based on the clinical practice observed in standard treatment, as opposed to the tightly defined processes of a randomized controlled trial. The population mix of gender, age and indications is representative of many INR patient self-monitoring programs. In addition to the methodological shortcomings inherent to every retrospective study, the elimination of the first 3 months familiarization period removes initial non- therapeutic INRs and may not be consistent with how TTR is calculated in other studies. Another limitation is the slightly different definition of the therapeutic and target ranges used in the Netherlands. Lack of verified causes of major clinical events, including death, in the NTS data prevents comparison of safety parameters with other studies. Finally, patients referred for patient self-monitoring may represent a select population, although this would not impact the applicability of the data to other patient self-monitoring settings. Taken together, we believe that these limitations do not materially impact our major conclusion on the clinically similar performance of INRatio2 and CoaguChek XS. CONCLUSION In our analysis of self-testing data from a large cohort of patients in the Netherlands, the effect of the choice of coagulation monitor (CoaguChek XS or INRatio2) on the TTR, minor and major safety outcomes of long-term anticoagulation management is clinically irrelevant. In contrast, other factors like patient gender, indication, choice of target range, and the VKA used exert a larger and statistically significant effect on the quality of INR management. Good INR control and high TTR, both of which can be achieved by self- testing, improve therapeutic efficacy and treatment safety for patients. Thus, self-testing should be promoted and recommended as an indispensable element in the monitoring of VKA coagulation. These results open the opportunity to look for other parameters to determine the choice of INR monitor, such as cost of the monitor and strips, ease of use and value added by the manufacturers in terms of service to patients and healthcare providers. ACKNOWLEDGMENTS Sponsorship and article processing charges for this study were funded by Alere International, Cranfield, UK. Dr. Rob Neeter, Chairman of the National Thrombosis Service, coordinated data retrieval and provided critical review of the manuscript. Dr. Toby Galbraith of IMC Healthcare Communication, London, UK, provided editorial assistance, supported by Alere International. Dr. Christian Kloss, Managing Director, Gesellschaft fu¨r Patientenhilfe DGP mbH (a subsidiary of Alere Health Improvement Atlanta) provided critical review of the manuscript. Alfred Mu¨ller, of Analytic Services Unternehmensberatungsges. mbH, provided statistical support and calculations, supported by Alere International. Jan Leendert Pouwel Brouwer collected data, drafted sections and provided critical review and approval of the manuscript. Hugo Stoevelaar collected data and provided critical review and approval of the manuscript. Christoph Sucker drafted sections and provided critical review and approval of the manuscript. All authors had full access to all of the data in this study and take complete responsibility Adv Ther