Target range aware: Once you set up targets in your CoaguChek INRange, it will clearly let the patient know about results out of that range. Risk of death reduced by 32% through self-management (RR 0.68, 95% CI 0.46 to 1.01, p=0.06) but not through self-testing (RR 0.97, 95% CI 0.78 to 1.19, p=0.74) even though the test for subgroup differences was not statistically significant (p=0.13). Self- monitoring halved the risk of mortality in participants with artificial heart valves (RR 0.54, 95% CI 0.32 to 0.92, p=0.02) but not in those with mixed clinical indication for anticoagulant therapy (RR 0.95, 95% CI 0.78 to 1.16, p=0.61). The subgroup difference between participants with artificial heart valves and those with mixed indication with regard to the number of deaths was statistically significant (p=0.05). No data were available from trials that enrolled participants with atrial fibrillation. Statistically significantly fewer deaths were recorded among participants who self-monitored their therapy compared with those who were routinely managed by their GP/doctor (RR 0.52, 95% CI 0.30 to 0.90, p=0.02). Evidence on patient-reported outcomes Anxiety associated with waiting time for results and not knowing their current coagulation status and risk

CoaguChek technology and quality have been recognised to facilitate VKA patient self-testing in a safe, accurate and reliable manner. 1 Gallagher,A.M., Setakis, E., Plumb, J.M., Clemens, A., van Staa, T.P. (2011). Risks of stroke and mortality associated with suboptimal anticoagulation in atrial fibrillation patients. Thromb Haemost 106, 968–977 As one of the UK’s largest suppliers of medical disposables, equipment, pharmaceuticals and medical services, we are constantly The results indicated that over a 10-year period, introducing self-monitoring would reduce the proportion of people experiencing a thromboembolic event by 2.5%, whilst slightly increasing the proportion having a major haemorrhagic event by 1.4%.Twenty one trials reported a total of 1472 major and minor bleeding events involving 8394 participants. 476 major bleeding events were reported in a total of 8202 participants and 13 of these 21 trials reported 994 minor bleeding events in a total of 5425 participants. No statistically significant differences were seen between self-monitoring participants (self-testing and self-management) and those in standard care for any bleeding events (relative risk [RR] 0.95, 95% confidence interval [CI] 0.74 to 1.21, p=0.66), major bleeding events (RR 1.02, 95% CI 0.86 to 1.22, p=0.80) and minor bleeding events (RR 0.94, 95% CI 0.65 to 1.34, p=0.73). The results were not affected by removing the UK-based trials or by restricting the included trials to those assessing the Coaguchek system. Similarly, sensitivity analyses restricted to trials using the CoaguChek XS system showed no differences from the all-trials results. A sensitivity analysis restricted to trials at low risk of bias slightly changed the estimate of effect but did not substantially impact on the findings (RR 0.59, 95% CI 0.27 to 1.30, p=0.19).

Senior Clinical Advisor, NIHR Evaluation Trials and Studies Coordinating Centre, University of Southampton The Committee considered the clinical evidence on the use of point-of-care coagulometers in people with atrial fibrillation or artificial heart valves. The Committee noted that 26 randomised controlled trials compared the use of point-of-care coagulometers for self-monitoring with standard anticoagulation control. The Committee noted that self-monitoring nearly halved the risk of thromboembolic events and substantially reduced the risk of mortality in people with artificial heart valves compared with standard monitoring. However, the Committee also noted that self-monitoring did not result in a significant reduction in the number of major and minor bleeding events compared with standard monitoring. The Committee discussed the heterogeneity in the trials and the applicability of the pooled results from the meta-analysis of the trial data to the UK population. It noted that the meta-analysis results showed low statistical heterogeneity and concluded that self-monitoring offered clinical benefit because it was likely to result in a significant reduction in thromboembolic events. The Committee concluded that the pooled effect estimates from the meta-analysis were likely to be applicable to the UK because there are no confounding biological differences between people receiving vitamin K antagonist therapy in the UK and those in other countries. Matchar, D.B., Jacobson, A., Dolor, R., Edson, R., Uyeda, L., et al. (2010). Effect of home testing of international normalized ratio on clinical events. N Engl J Med 363, 1608–1620 The Diagnostics Advisory Committee reviewed the evidence available on the clinical and cost effectiveness of self-monitoring coagulometers for self-testing or self-managing coagulation status in people on long-term vitamin K antagonist therapy who have atrial fibrillation or heart valve disease.

The purpose of this assessment is to evaluate the clinical and cost effectiveness of using the CoaguChek XS system and the INRatio2 PT/INR monitor for self-monitoring (self-testing or self-managing) coagulation status in people on long-term vitamin K antagonist therapy who have atrial fibrillation or heart valve disease. The condition

products in Primary Care across England and Scotland. To ensure a seamless transfer of services, Roche Diagnostics and One trial compared self-management with self-testing in children and provided quality-of-life data using the KIDCLOT PAC QL parent-proxy (parents’ quality of life and their assessment of child's quality of life) and the child teen KIDCLOT PAC QL. The 5 common themes identified were: awareness, communication, relationship between parent and child, flexibility and anxiety. Costs and cost effectiveness Approximately 47% of people with atrial fibrillation currently receive vitamin K antagonist therapy. It is estimated that a further 30% of people with atrial fibrillation could receive this therapy but currently do not. People with atrial fibrillation are at a 5–6 times greater risk of stroke, with 12,500 strokes directly attributable to atrial fibrillation occurring every year in the UK. Treatment with warfarin reduces this risk by 50–70%. Heart valve disease Among participants with artificial heart valves, self-monitoring resulted in a statistically significant higher INR TTR compared with standard care. In 2 trials that included participants with atrial fibrillation, no TTR differences were found between self-monitoring and standard care. Time to test resultdaily, or on alternate days, until it is within the therapeutic range (usually between 2.0 and 3.0, ideally 2.5) on 2 consecutive occasions The External Assessment Group carried out alternative non-base case scenarios, to assess the impact of using self-monitoring to replace standard monitoring tests (that is no increase in the number of tests done annually). It was assumed that there was no difference in clinical effectiveness between self-management, self-testing and standard care. Under most of these scenarios, standard monitoring was found to be less costly than self-monitoring. However, self-testing and self-management with the INRatio2 PT/INR monitor and the CoaguChek XS system dominated standard monitoring when carried out exclusively in secondary care. sharing our knowledge, or delivering unbeatable value. Our partnership with Roche allows just that.

Twelve trials reported INR values in therapeutic range and there was variation in the measures used so pooling the data was not appropriate. In 8 of these trials, the proportion of INR values in therapeutic range ranged from 43.2% to 80.8% for self-monitoring and from 22.3% to 72.0% for standard care. In 4 trials that reported the proportion of participants in therapeutic range, the values ranged from 53.0% to 72.9% for self-monitoring and from 43.2% to 72.0% for standard care. Ten of the trials reported higher proportions of INR values in therapeutic range or larger proportions of participants in therapeutic range for self-monitoring than for standard care. Colour display: The colour display makes important information such as colour-coded results noticeable so that they are easy to read and understand. The systematic review identified 12 relevant economic evaluations. All of these evaluations compared INR self-monitoring strategies with standard care and were assessed against the NICE reference case by the External Assessment Group. The results of the studies included in the systematic review varied widely and showed that the cost effectiveness of self-monitoring was dependent on a number of key factors. Rivaroxaban for the prevention of stroke and systemic embolism in people with atrial fibrillation. NICE technology appraisal guidance 256 (2012). February 2014 11 Diagnostics Advisory Committee members and NICE project team Diagnostics Advisory CommitteeIt is advised anyone whose reading on their test strip is above 4.5 INR should discuss their results with a healthcare professional.