HAEMOSTASIS AND THROMBOSIS


were changed. All FDA clearances after that date now have to meet the higher CLSI parameters for sensitivity (97%) and NPV (98%).


Supporting laboratory efficiency When choosing the right reagent, cost is only one factor. Health technology assessment (HTA) decision-makers have to take into consideration the overall reliability of assay performance, its impact on patients; and whether the right choice of assay will reduce the need for other more costly and invasive procedures (such as imaging).


It may not be immediately evident that this is a problem the laboratory has to resolve. But the growing trend towards HTA takes all these costs into account. This has implications for a laboratory’s own efficiency evaluation – key performance indicators (KPI) that are now built into NHS diagnostic accountability across all departments. Our laboratories are already dealing


with increasing workloads, demand for quicker sample processing and even faster turnaround times (TAT). Pressure to produce results in a cost-effective way has laboratory directors and managers strug - gling to meet the increased demands with fewer experienced staff and tightened budgets. Understanding how HTA concerns might affect their KPI outcomes is becoming essential.


Health technology assessment looks at the wider health economics of carrying out certain diagnostic protocols, related patient costs, such as length of stay and the allocation of clinical resources, including additional costs of imaging when faced with a potential DVT.


Increasing confidence in results Stago’s approach to HTA is to set down four essential stages6


that everyone


involved in a diagnostic decision-making process should be considering: n how well does this ‘technology’ work in use?


n what are the potential risk and benefits?


n compare costs and consequences n how acceptable is the test taking into account different population groups?


The right choice of assay will have a significant impact on the overall workflow and efficiency of the laboratory. Not only will less retesting be required but the laboratory and its clinical partners will have greater confidence in the reliability of the results to rule out DVT, without routinely running the test and still sending the patient for costly confirmatory imaging. The independent health economic report on Stago’s D-dimer assay


31


Pretest probability algorithm score intermediate probability


D-dimer: Negative (<threshold value)


(≥threshold value)


Imaging techniques


(–) (+) No DVT or PE


Evaluation for other aetiologies causing symptoms


Recommended algorithm for suspected venous thromboembolism.


highlighted a further example of savings from the health technology perspective. It looked at what savings could be made if a hospital could remove just one diagnostic process – that of imaging. The analysis was able to show that this would reduce diagnostic costs by well over one-third when the use of the Stago D-dimer assay was compared with four other available D-dimer tests with lower specificity levels. If we extrapolate data for healthcare systems as a whole, the indications are that 60% of VTE patients with low to moderate pre-test probability (PTP) could safely be ruled out when using Stago’s D-dimer test. With VTE the number one cause of preventable deaths in the UK, and 55–60% of VTE cases occurring during or following hospitalisation, consider the savings that could be made by being able to rule out VTE safely using a simple blood test.


The choice of D-dimer assay is just one example of how it is possible to conserve costs and still improve the patient experience. Taking an HTA approach across other aspects of pathology and the clinical pathway would deliver true patient-centred value.


References 1 Jha AK, Larizgoitia I, Audera-Lopez C,


Prasopa-Plaisier N, Waters H, Bates DW. The global burden of unsafe medical care: analytic modeling of observational studies. BMJ Qual Saf 2013; 22 (10): 809–15. doi: 10.1136/bmjqs-2012-001748.


2 House of Commons Health Committee Report on the Prevention of Venous Thromboembolism in Hospitalised Patients (www.publications.parliament.uk/pa/ cm200405/cmselect/cmhealth/99/9902.html).


3 National Institute for Health and Care Excellence. Pulmonary embolism. How common is it? London: NICE, 2020 (https://cks.nice.org.uk/topics/pulmonary- embolism/background-information/ prevalence).


4 Belohlávek J, Dytrych V, Linhart A. Pulmonary embolism, part I: Epidemiology, risk factors and risk stratification, pathophysiology, clinical presentation, diagnosis and nonthrombotic pulmonary embolism. Exp Clin Cardiol 2013; 18 (2): 129–38.


5 Stago. Economic Evaluation of STA-Liatest D-Di for Exclusion of Venous thromboembolism (VTE) in ED for the US Healthcare System (www.stago.com.au/ fileadmin/user_upload/60- Stago_ANZ/pdf/AliraHealth_Stago_ D_Dimer_Evaluation_Feb2019.pdf)


6 Stago. (www.stago-uk.com/products- services/value-based-healthcare).


PPi


Gillian Eyre is Sales and Marketing Manager, Stago UK.


Further information is available from: Diagnostica Stago UK Theale Lakes Business Park 12 Moulden Way, Sulhamstead Reading RG7 4GB Tel: +44 (0)845 054 0614 Web: www.stago-uk.com


DECEMBER 2021 WWW.PATHOLOGYINPRACTICE.COM DVT or PE


D-dimer: Positive


Unlikely: Low or High probability Likely:


Treatment


PATHOLOGY IN PRACTICE


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41