Point-of-care coagulometers (the CoaguChek XS system and the INRatio2 PT/INR monitor

Point-of-care coagulometers (the CoaguChek XS system and the INRatio2 PT/INR monitor) for self-monitoring coagulation status in people on long-term vitamin K antagonist therapy who have atrial fibrillation or heart valve disease

There are increasing numbers of people with atrial fibrillation, heart valve disease or other cardiac conditions who are at high risk of thrombosis, requiring long-term oral anticoagulation therapy (OAT). The goal of OAT, generally with warfarin (a type of vitamin K antagonist), is to establish a balance between bleeding and clotting. Under-anticoagulation increases the risk of thromboembolism while over-anticoagulation increases the risk of haemorrhage; hence treatment with warfarin requires frequent monitoring. The blood coaguability of people taking warfarin is monitored by the use of the international normalised ratio (INR) which is a standardised unit for measuring the time it takes for blood to clot. As standard practice, warfarin monitoring is managed by healthcare professionals in anticoagulant clinics based in hospitals using laboratory testing or managed in primary care (with or without the use of laboratory services). The other option for warfarin monitoring is the use of a personal testing machine at home (known as a point-of-care test) which allows people to perform self-testing (with results managed by healthcare professional) or self-management (when people perform the test and alter the dose of anticoagulation therapy themselves according to a personalised protocol). Self-testing and self-management are together referred to as self-monitoring.

Outcome and Translation

This diagnostic assessment review informed NICE diagnostics guidance (DG14: Atrial fibrillation and heart valve disease: self-monitoring coagulation status using point-of-care coagulometers (the CoaguChek XS system). Based on the evidence presented in the report, the NICE appraisal committee recommended two coagulometers (CoaguChek XS and InRatio2 PT/INR) for use by people taking long-term anti-blood clotting therapy who have atrial fibrillation or heart valve disease, if they prefer and are able to effectively use this type of monitoring. The report was also reviewed by the Scottish Health Technologies Group, and used to inform updated advice to the NHS in Scotland.

Project page at National Institute for Health and Care Excellence (NICE)

Prospero record for this study. (Prospero is an international prospective register of systematic reviews in health and social care).

NIHR Signal - 'Self-monitoring of warfarin is safe and cost-effective'.

HERU researchers involved in this research project: Graham Scotland and Emma Tassie

External collaborators: P Sharma, M Cruickshank, C Fraser, C Burton, CR Ramsay and M Brazzelli (for the Aberdeen Health Technology Assessment Group)

Publications

Sharma, P., Scotland, G., Cruickshank, M., Tassie, E., Fraser, C., Burton, C., Croal, B., Ramsay, C. R. and Brazzelli, M. (2013) Clinical and cost-effectiveness of point-of-care tests (CoaguChek system, INRatio2 PT/INR monitor and ProTime Microcoagulation system) for the self-monitoring of the coagulation status of people receiving long-term vitamin K antagonist therapy compared with standard UK practice: systematic review and economic evaluation. Diagnostic Assessment Report submitted in support of the National Institute for Health and Care Excellence (NICE) Diagnostic Assessments Programme.

Sharma, P., Scotland, G., Cruickshank, M., Tassie, E., Fraser, C., Burton, C., Croal, B., Ramsay, C. R. and Brazzelli, M. (2015) 'Is self-monitoring an effective option for people receiving long-term vitamin K antagonist therapy? A systematic review and economic evaluation', BMJ Open, 5(6), e007758.

Sharma, P., Scotland, G., Cruickshank, M., Tassie, E., Fraser, C., Burton, C., Croal, B., Ramsay, C. R. and Brazzelli, M. (2015) 'The clinical effectiveness and cost-effectiveness of point-of-care tests (CoaguChek system, INRatio2 PT/INR monitor and ProTime Microcoagulation system) for the self-monitoring of the coagulation status of people receiving long-term vitamin K antagonist therapy, compared with standard UK practice: systematic review and economic evaluation', Health Technology Assessment, 19(48).

Scotland, G. (2015) 'Is self-monitoring a cost-effective option for people receiving long-term vitamin K antagonist (Warfarin) therapy?', HERU Policy Brief, University of Aberdeen, September 2015.

Presentations

Sharma, P., Scotland, G., Cruickshank, M., Tassie, E., Fraser, C., Burton, C., Croal, B., Ramsay, C. R. and Brazzelli, M. (2015) 'Assessment of diagnostic tests and the impact on decision making: the example of self-monitoring of oral anticoagulation therapy', HTAi 2015. Global Efforts in Knowledge Transfer: HTA to Health Policy and Practice, Oslo, Norway, 15-17 June 2015.