April 2022, Roche Diagnostics will partner with Williams Medical We’re pleased to announce that from 4th April 2022, Williams Medical and Roche Diagnostics will be joining forces 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

morbidity (for example, thromboembolic and cerebrovascular events) and mortality from INR testing and vitamin K antagonist therapy This document has been prepared for public consultation. It summarises the evidence and views that have been considered, and sets out the draft recommendations made by the Committee. NICE invites comments from registered stakeholders, healthcare professionals and the public. This document should be read along with the evidence base (the diagnostics assessment report). Professor of Public Health and Clinical Epidemiology, Peninsula Technology Assessment Group (PenTAG) Relative treatment effects were estimated and applied separately for self-testing and self-management.A sensitivity analysis was also conducted to approximate the cost effectiveness of self-monitoring for a cohort of children with an artificial heart valve on long-term vitamin K antagonist therapy. For this analysis, the cohort age was set to 10, the baseline risk of thromboembolic events was reduced to 1.4%, and the risk of all-cause mortality after a stroke was set at 14.5. Under this scenario, self-monitoring with the CoaguChek XS system and the INRatio2 PT/INR monitor dominated standard monitoring. However, it should be noted that the standardised mortality ratio estimated for an 18–55 year old cohort of artificial heart valve participants was applied because no robust data were identified to appropriately adjust the risk of death from all causes in children with an artificial heart valve. One trial (n=28) compared self-management with self-testing in children and reported that 1 parent did not favour self-management because of the increased anxiety related to INR measurements. Acceptability of the tests

Value": "The CoaguChek XS System is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. The CoaguChek XS System uses fresh capillary or nonanticoagulated venous whole blood.", products in Primary Care across England and Scotland. To ensure a seamless transfer of services, Roche Diagnostics and Each CoaguChek XS PT test strip is subjected to a quality control before measurement with the CoaguChek XS blood coagulation meter. This quality control detects any faults in the respective test strip, for instance caused by damp storage. This guarantees correctly determined measurement results with the help of the CoaguChek device and thus offers high reliability for the user.If you’re worried about your readings when using these test strips, we’d recommend speaking to your GP, anticoagulant clinic or a pharmacist as soon as possible. Wan, Y., Heneghan, C., Perera, R., Roberts, N., Hollowell, J., et al. (2008). Anticoagulation control and prediction of adverse events in patients with atrial fibrillation: a systematic review. Circ Cardiovasc Qual Outcomes 1, 84–91 The Committee considered the cost effectiveness of self-testing and self-managing individually. The findings showed that self-management alone is highly cost effective (dominant) but that self-testing alone is not cost effective, compared with standard monitoring. The Committee noted that these findings were based on the contrasting pooled-effect estimates obtained from the meta-analysis of randomised controlled trials, based on thromboembolic events while self-testing and self-managing. The Committee discussed the impact of 1 large trial by Matchar et al. (2010) (see section 6.5) on the cost effectiveness of self-testing and noted that although this trial did not show a reduction in clinical adverse events, it did show an increase in the time in therapeutic range. The Committee discussed the impact on the ICERs if the economic model was driven by time in therapeutic range rather than adverse events for self-testing. The Committee concluded that self-testing may be more cost effective if the model had been based on time in therapeutic range. The Committee also considered the costs of self-managing and self-testing and noted that self-testing was more expensive because of higher administration costs. The Committee heard from the External Assessment Group that if the pooled-effect estimates from self-monitoring were applied to self-testing, self-testing would become cost effective even with the higher administration costs this incurred. The Committee concluded that it was likely that the increase in time in therapeutic range shown for self-testing in the trial would lead to a reduction in adverse events compared with standard clinical practice in the UK. The Committee therefore concluded that it was likely that the clinical benefits of self-testing had been underestimated in the economic analyses and that both self-testing and self-managing were cost effective. 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). The main causes of heart valve disease are congenital heart disease and other diseases such as rheumatic fever, lupus, cardiomyopathy and endocarditis. Aortic stenosis is the most common type of valve disease and it affects around 1 in 20 adults over the age of 65 years in the UK.

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 The INRatio2 PT/INR monitor analyses fresh capillary blood and when the blood sample is applied to the sample well, it is drawn through the narrow channels by capillary action to the clot cells, where the impedance of the sample is measured by the monitor through the electrodes. Clot cells have reagents applied and the reagents are different for each channel. One channel contains the thromboplastin reagent for the prothrombin time test. The other 2 channels contain reagents that produce a low and high control time, regardless of the clotting time of the sample. Patients who spend a high proportion of time (> 70%) in the therapeutic range achieve better clinical outcomes.2,3 Studies show that this can be achieved through self-testing using CoaguChek technology. 1,4Amperometric (electrochemical) determination of the PT time after activation of the coagulation with human recombinant thromboplastin INR monitoring can be managed by local anticoagulant clinics in primary care, but sometimes clinics are based in secondary care, involving travel to hospital. The NICE anticoagulation commissioning guide (2013) states that anticoagulation therapy services can be delivered in a number of different ways, and that mixed models of provision may be needed across a local health region. This could include full service provision in secondary or primary care, shared provision, domiciliary provision and self-management. Services may be managed by a range of healthcare professionals including nurses, pharmacists and general practitioners. 4 The diagnostic tests The interventions 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 Results trend reporting: The CoaguChek INRange meter will let your patients know if their most recent result is higher or lower than their last result to help understand trends. The Committee discussed the different versions of the CoaguChek systems. The Committee heard from clinical specialists and the manufacturer that changes had been made to the different versions to improve reliability and accuracy. The Committee concluded that results from the CoaguChek XS system were likely to be at least as good as those obtained from trials in which previous versions of the system were used. The Committee also noted that 4 trials investigated the use of the CoaguChek XS system. The Committee concluded that it was appropriate to pool the results of trials using different versions of the CoaguChek system.

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. Christensen, H., Lauterlein, J.-J., Sørensen, P.D., Petersen, E.R.B., Madsen, et al. (2011). Home management of oral anticoagulation via telemedicine versus conventional hospital-based treatment. Telemed J E-Health Off J Am Telemed Assoc 17, 169–176 Another trial measured quality of life by means of the Health Utilities Index Mark 3. It reported a statistically significant gain in health utilities at the 2-year follow-up among self-testing participants compared with those managed in high quality anticoagulant clinics (p<0.001). The same investigators also measured anticoagulant satisfaction using Duke Anticoagulation Satisfaction Scale. They found that the degree of satisfaction was higher in self-testing participants compared with those in standard care (p=0.002).

Step 4:

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.