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Point-of-care testing INR: an overview

  • Doris Barcellona , Lara Fenu and Francesco Marongiu EMAIL logo
Published/Copyright: October 18, 2016

Abstract

Oral anticoagulant therapies with the anti-vitamin K drugs (AVK), warfarin, acenocoumarol and phenprocoumon, are employed in primary and secondary anti-thrombotic prophylaxis in patients with venous thromboembolism, atrial fibrillation and cardiac mechanical valves. However, a monitoring test such as the International Normalized Ratio (INR) is required. The periodic monitoring of this therapy entails discomfort for the patients. Telemedicine and telecare can provide significant aid in the management of this therapy allowing patients to perform the test at home or anywhere else with a portable device, i.e. point-of-care testing (POCT), and to send the result to a thrombosis (TC) via web. Patients can receive dose adjustment sent back by the TC. The effectiveness of this type of management is equal or superior to the traditional AVK monitoring in terms of hemorrhagic and thrombotic events. Analysis of the costs with a horizon of 10 years reveals that both self-testing and self-management are cost-effective. The aim of this overview is to describe the pros and cons of the use of POCT as an alternative in the monitoring of AVK. In particular, description of the POCT, decentralization, quality of the therapy, safety and costs will be examined.

Acknowledgments

We thank Mr. Barry Mark Wheaton for his editing assistance.

  1. Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

  2. Research funding: None declared.

  3. Employment or leadership: None declared.

  4. Honorarium: None declared.

  5. Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

References

1. Ageno W, Gallus AS, Wittkowsky A, Crowther M, Hylek EM, Palareti G, et al. Oral anticoagulant therapy: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest 2012;141:e44S–88S.10.1378/chest.11-2292Search in Google Scholar PubMed PubMed Central

2. Stenflo J, Fernlund P, Egan W, Roepstorff P. Vitamin K dependent modifications of glutamic acid residues in prothrombin. Proc Natl Acad Sci USA 1974;71:2730–33.10.1073/pnas.71.7.2730Search in Google Scholar PubMed PubMed Central

3. Quick AJ. The prothrombin in hemophilia and in obstructive jaundice. J Biol Chem 1935;109:73–4.Search in Google Scholar

4. Kirkwood TB. Calibration of reference thromboplastins and standardization of the prothrombin time ratio. Thromb Haemost 1983;49:238–44.10.1055/s-0038-1657371Search in Google Scholar

5. Ansell J, Holden A, Knapic N. Patient self-management of oral anticoagulant guided by capillary (fingerstick) whole blood prothrombin times. Arch Intern Med 1989;149:2509–11.10.1001/archinte.1989.00390110085018Search in Google Scholar

6. Taborski U, Muller-Berghaus G. State-of-the-art of patient self-management for control of oral anticoagulation. Semin Thromb Hemost 1999;25:43–7.10.1055/s-2007-996423Search in Google Scholar PubMed

7. Watzke HH, Forberg E, Svolba G, Jimenez-Boj E, Krinninger B. A prospective controlled trial comparing weekly self-testing with standard management of patients on stable oral anticoagulation. Thromb Haemost 2000;83:661–5.10.1055/s-0037-1613888Search in Google Scholar

8. Gadisseur AP, Breukink-Engbers WG, van der Meer FJ, van den Besselaar AM, Sturk A, Rosendaal FR. Aanticoagulant therapy through patient self-management and management by specialized anticoagulation clinics in the Netherlands: a randomized clinical trial. Arch Int Med 2003;163:2639–46.10.1001/archinte.163.21.2639Search in Google Scholar PubMed

9. Cosmi B, Palareti G, Carpanedo M, Pengo V, Biasiolo A, Rampazzo P, et al. Assessment of patient capability to self-adjust oral anticoagulant dose: a multicentre study on home use of portable prothrombin time monitor (COAGUCHEK). Haematologica 2000;85:826–31.Search in Google Scholar

10. Barcellona D, Fenu L, Cornacchini S, Marongiu F. Telemedicine can improve the quality of oral anticoagulation using portable devices and self-testing at home. J Telemed Telecare 2013;19:298–301.10.1177/1357633X13501764Search in Google Scholar PubMed

11. Health Quality Ontario. Point-of-care international normalized ratio (INR) monitoring devices for patients on long-term oral anticoagulation therapy. Ont Health Technol Assess Ser 2009;9:1–114.Search in Google Scholar

12. Christensen TD, Larsen TB. Precision and accuracy of point-of-care testing coagulometers used for self-testing and self-management of oral anticoagulant therapy. J Thromb Haemost 2012;10:251–60.10.1111/j.1538-7836.2011.04568.xSearch in Google Scholar PubMed

13. Tripodi A, Arbini AA, Chantarangkul V, Bettega D, Mannucci PM. Are capillary whole blood coagulation monitors suitable for the control of oral anticoagulant treatment by the international normalized ratio? Thromb Haemost 1993;70:921–4.10.1055/s-0038-1649700Search in Google Scholar

14. Sølvik UØ, Stavelin A, Christensen NG, Sandberg S. External quality assessment of prothrombin time: the split-sample model compared with external quality assessment with commercial control material. Scand J Clin Lab Invest 2006;66:337–49.10.1080/00365510600684580Search in Google Scholar PubMed

15. Stavelin A, Meijer P, Kitchen D, Sandberg S. External quality assessment of point-of-care international normalized ratio (INR) testing in Europe. Clin Chem Lab Med 2011;50:81–8.10.1515/cclm.2011.719Search in Google Scholar

16. Kitchen S, Kitchen DP, Jennings I, Woods TA, Walker ID, Preston FE. Point-of-care international normalized ratios: UK NEQAS experience demonstrates necessity for proficiency testing of three different monitors. Thromb Haemost 2006;96:590–6.10.1160/TH04-01-0031Search in Google Scholar

17. Jespersen J, Poller L, van den Besselaar AM, van der Meer FJ, Palareti G, Tripodi A, et al. External quality assessment (EQA) for CoaguChek monitors. Thromb Haemost 2010;103:936–41.10.1160/TH09-10-0683Search in Google Scholar PubMed

18. Barcellona D, Fenu L, Cornacchini S, Marongiu F. Point-of-care (POCT) prothrombin time monitors: is a periodical control of their performance useful? Thromb Res 2009;123:775–9.10.1016/j.thromres.2008.08.006Search in Google Scholar PubMed

19. Pengo V. Monitoring oral anticoagulants: new strategies for an emerging problem. Intern Emerg Med 2006;1:3–4.10.1007/BF02934713Search in Google Scholar PubMed

20. Testa S, Alatri A, Paoletti O, Morstabilini G, Medagliani MA, Denti N, et al. Reorganization of an anticoagulation clinic using a telemedicine system: description of the model and preliminary results. Intern Emerg Med 2006;1:24–9.10.1007/BF02934716Search in Google Scholar PubMed

21. St John A. The evidence to support point-of-care testing. Clin Biochem Rev 2010;31:111–19.Search in Google Scholar

22. Goble JA, Rocafort PT. Point-of-care testing: future of chronic disease state management? J Pharm Pract 2015:pii: 0897190015587696. [Epub ahaed of print].10.1177/0897190015587696Search in Google Scholar PubMed

23. Palareti G, Poggi M, Guazzaloca G, Savino A, Coccheri S. Assessment of mental ability in elderly anticoagulated patients: its reduction is associated with less satisfactory quality of treatment. Blood Coag Fibrinol 1997;8:411–17.10.1097/00001721-199710000-00006Search in Google Scholar

24. Ward A, Tompson A, Fitzmaurice D, Sutton S, Perera R, Heneghan C. Cohort study of anticoagulation self-monitoring (CASM): a prospective study of its effectiveness in the community. Br J Gen Pract 2015;65:e428–37.10.3399/bjgp15X685633Search in Google Scholar PubMed PubMed Central

25. Optimal Warfarin Management for the Prevention of Thromboembolic Events in Patients with Atrial Fibrillation: A Systematic Review of the Clinical Evidence [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health, 2011. CADTH Optimal Use Reports.Search in Google Scholar

26. Rosendaal FR, Cannegieter SC, van der Meer FJ, Briët E. A method to determine the optimal intensity of oral anticoagulant therapy. Thromb Haemost 1993;69:236–39.10.1055/s-0038-1651587Search in Google Scholar

27. Schneeweiss S, Gagne JJ, Patrick AR, Choudhry NK, Avorn J. Comparative efficacy and safety of new oral anticoagulants in patients with atrial fibrillation. Circ Cardiovasc Qual Outcomes 2012;5:480–6.10.1161/CIRCOUTCOMES.112.965988Search in Google Scholar

28. Dallalzadeh LO, Go AS, Chang Y, Borowsky LH, Fang MC, Singer DE. Stability of high-quality warfarin anticoagulation in a community-based atrial fibrillation cohort: the Anticoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. Am Heart Assoc 2016;5:pii: e003482.10.1161/JAHA.116.003482Search in Google Scholar

29. Wan Y, Heneghan C, Perera R, Roberts N, Hollowell J, Glasziou P, et al. Anticoagulation control and prediction of adverse events in patients with atrial fibrillation: a systematic review. Circ Cardiovasc Qual Outcomes 2008;1:84–91.10.1161/CIRCOUTCOMES.108.796185Search in Google Scholar

30. Senoo K, Lip GY. Female sex, time in therapeutic range, and clinical outcomes in atrial fibrillation patients taking warfarin. Stroke 2016;47:1665–8.10.1161/STROKEAHA.116.013173Search in Google Scholar

31. Wells PS, Brown A, Jaffey J, McGahan L, Poon MC, Cimon K. Safety and effectiveness of point-of-care monitoring devices in patients on oral anticoagulant therapy: a meta-analysis. Open Med 2007;1:e131–46.10.2139/ssrn.992909Search in Google Scholar

32. Garcia-Alamino JM, Ward AM, Alonso-Coello P, Perera R, Bankhead C, Fitzmaurice D, et al. Self-monitoring and self-management of oral anticoagulation. Cochrane Database Syst Rev 2010;4:CD003839.10.1002/14651858.CD003839.pub2Search in Google Scholar

33. Bloomfield HE, Krause A, Greer N, Taylor BC, MacDonald R, Rutks I, et al. Meta-analysis: effect of patient self-testing and self-management of long term anticoagulation on major clinical outcomes. Ann Intern Med 2011;154:472–82.10.7326/0003-4819-154-7-201104050-00005Search in Google Scholar

34. Heneghan C, Ward A, Perera R. Self-monitoring of oral anticoagulation: systematic review and meta-analysis of individual patient data. Lancet 2012;379:322–34.10.1016/S0140-6736(11)61294-4Search in Google Scholar

35. Sharma P, Scotland G, Cruickshank M, Tassie E, Fraser C, Burton C, et al. Is self-monitoring an effective option for people receiving long-term vitamin K antagonist therapy? a systematic review and economic evaluation. BMJ Open 2015;5:e007758.10.1136/bmjopen-2015-007758Search in Google Scholar PubMed PubMed Central

36. Matchar DB, Jacobson A, Dolor R, Edson R, Uyeda L, Phibbs CS, et al. Effect of home testing of international normalized ratio on clinical events. N Engl J Med 2010;363:1608–20.10.1056/NEJMoa1002617Search in Google Scholar PubMed

37. Meyer S, Frei CR, Kelly RD. Impact of a new method of warfarin management on patient satisfaction, time and cost. Pharmacotherapy 2013;33:1147–55.10.1002/phar.1344Search in Google Scholar PubMed

38. Barcellona D, Fenu L, Vannini ML, Piras M, Marongiu F. Antiphospholipid syndrome patients: the performance of Coaguchek XS in the monitoring of Vitamin-K Antagonists. Thromb Res 2012;129:e168–70.10.1016/j.thromres.2012.01.011Search in Google Scholar PubMed

39. Pengo V, Crippa L, Falanga A, Finazzi G, Marongiu F, Moia M, et al. Phase III studies on novel oral anticoagulants for stroke prevention in atrial fibrillation: a look beyond the excellent results. J Thromb Haemost 2012;10:1979–87.10.1111/j.1538-7836.2012.04866.xSearch in Google Scholar PubMed

Received: 2016-5-1
Accepted: 2016-9-15
Published Online: 2016-10-18
Published in Print: 2017-6-1

©2017 Walter de Gruyter GmbH, Berlin/Boston

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