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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. One trial reported the time for each INR monitoring (that is, time from INR measurement to test results) and the total time spent for anticoagulant management during the 4-month follow-up period. The time spent for each INR measurement by self-managed participants was statistically significantly lower (mean 5.3 minutes, standard deviation [SD] 2.6 minutes) compared with the time spent by participants receiving standard care (mean 158 minutes, SD 67.8 minutes, p<0.001). During the 4-month follow-up, the total time spent for anticoagulation monitoring by participants in standard care was statistically significantly higher (mean 614.9 minutes, SD 308.8 minutes) than the total time spent by participants who self-managed their therapy (mean 99.6 minutes, SD 46.1 minutes, p<0.0001). Patient compliance with testing 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. There are a number of conditions that can result in people having an increased risk of thrombosis and consequently, receiving long- term vitamin K antagonist therapy. These conditions include atrial fibrillation and heart valve disease. Guidance on self-monitoring the coagulation status of people who have had a venous thromboembolism and are receiving long-term vitamin K antagonist therapy is included in Venous thromboembolic diseases (NICE clinical guideline 144) and so this population is not included in the scope of this diagnostics assessment of self-monitoring coagulometers. Atrial fibrillation After consultation, the Committee will meet again to consider the evidence, this document and comments from the consultation. After considering these comments, the Committee will prepare its final recommendations, which will be the basis for NICE’s guidance on the use of the technology in the NHS in England.

7  Proposed recommendations for further research

thereafter, depending on the stability of the INR, at longer intervals (for example, up to every 12 weeks, if agreed locally). 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. 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 Heneghan, C., Alonso-Coello, P., Garcia-Alamino, J.M., Perera, R., Meats, E., Glasziou, P. (2006). Self-monitoring of oral anticoagulation: a systematic review and meta-analysis. Lancet 367, 404–411 Of the 21 trials, 2 trials enrolled participants with atrial fibrillation, 6 trials enrolled participants with artificial heart valves and 13 trials enrolled participants with mixed indication. No statistically significant subgroup differences were found for bleeding events according to the type of clinical indication or the type of control standard care. Thromboembolic events

Professor in Health Economics, School of Health and Related Research (ScHARR), University of Sheffield ProductNameAddition": "cobas infinity edge unite is a software as a service (SaaS) offering that seamlessly connects POC devices used in ambulatory care settings.", The CoaguChek XS system is recommended for self-monitoring coagulation status in people on long-term vitamin K antagonist therapy who have atrial fibrillation or heart valve disease if: 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. Test principle: electrochemical measurement of thromboplastin time after activation of blood coagulation with human recombinant thromboplastinThe INRatio2 PT/INR monitor does a self-test when it is turned on and each test strip has a code that is accepted by the monitor if the strip code is in the correct format. The monitor uses 4 × AA batteries or a mains adapter as a power source, and can connect to a printer or computer through the RS232 serial communication. The comparator: INR testing

The following organisations accepted the invitation to participate in this assessment as registered stakeholders. They were invited to attend the scoping workshop and to comment on the diagnostics assessment report. Permits systems communications with hospital and laboratory information systems via Roche cobas IT 1000 or other standards-compliant data management solutionsWilliams Medical will work closely together to ensure superb levels of customer satisfaction are maintained. Atrial fibrillation is the most common heart arrhythmia and affects around 800,000 people in the UK. It can affect adults of any age but it is more common in older people; 0.5% of people aged 50–59 years and around 8% of people aged over 65 years are estimated to be affected. Atrial fibrillation is also more common in men than women, and is more common in people with other conditions, such as high blood pressure, atherosclerosis and heart valve problems.