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Home management of INR in the public health system: feasibility of self-management of oral anticoagulation and long-term performance of individual POC devices in determining INR

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Abstract

The home prothrombin time/international normalized ratio (PT/INR) self-management could be convenient for patients, enhancing treatment compliance and improving the quality of the oral anticoagulation. However, patient self-management (PSM) of oral anticoagulation may not be feasible for up to half of the patients due to cognitive or educational issues. In the present study, we aimed to evaluate the feasibility of a PSM program in a public health medical center that provides care for low-income patients. We also aimed to determine the accuracy of individual point-of-care devices (CoaguChek XS®) during long-term of home manipulation. Patients’ time-in-therapeutic range (TTR) and perception of quality of life, were evaluated at scheduled study-visits to the center. Additionally, the accuracy of individual CoaguChek XS® was evaluated in comparison to the standard automated coagulometer at scheduled study-visits to the center. Twenty-five patients were included in the PSM program. The median TTR of patients was 75 % before inclusion, 72 % at 3 months, 75 % at 6 months and 100 % at 12 months after the beginning of self-management (P = 0.14).The median DASS scores were 64, 63, 61.5 and 71.5 before inclusion and at 3, 6 and 12 months, respectively (P = 0.09). One hundred paired INR values were obtained. Correlation between INR values delivered by individual CoaguChek XS® and the automated coagulometer was 94 % and the mean result bias was 0.07 INR units. The coefficient of correlation and the mean bias between methods was stable during 24 months of follow-up. The present study suggests that PSM is feasible for patients treated in the public health system and that the results delivered by CoaguChek XS® have long-term reliability.

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References

  1. Hambleton J (2004) Home monitoring of anticoagulation. J Thromb Thrombolysis 16:39–42. doi:10.1023/B:THRO.0000014591.32012.1f

    Article  Google Scholar 

  2. Samsa GP, Matchar DB (2000) Relationship between test frequency and outcomes of anticoagulation: a literature review and commentary with implications for the design of randomized trials of patient self-management. J Thromb Thrombolysis 9:283–292

    Article  CAS  PubMed  Google Scholar 

  3. Holbrook A, Schulman S, Witt DM, Vandvik PO, Fish J, Kovacs MJ, Svensson PJ, Veenstra DL, Crowther M, Guyatt GH (2012) Evidence-based management of anticoagulant therapy. Antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest 141:e152S–e184S. doi:10.1378/chest.11-2295

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  4. Eitz T, Schenk S, Fritzsche D, Bairaktaris A, Wagner O, Koertke H, Koerfer R (2008) International normalized ratio self-management lowers the risk of thromboembolic events after prosthetic heart valve replacement. Ann Thorac Surg 85:949–955. doi:10.1016/j.athoracsur.2007.08.071

    Article  PubMed  Google Scholar 

  5. Christensen TD, Johnsen SP, Hjortdal VE, Hasenkam JM (2007) Self-management of oral anticoagulant therapy: a systematic review and meta-analysis. Int J Cardiol 118:54–61. doi:10.1016/j.ijcard.2006.06.018

    Article  PubMed  Google Scholar 

  6. Heneghan C, Alonso-Coello P, Garcia-Alamino JM, Perera R, Meats E, Glasziou P (2006) Self-monitoring of oral anticoagulation: a systematic review and meta-analysis. Lancet 367:404–411. doi:10.1016/S0140-6736(06)68139-7

    Article  CAS  PubMed  Google Scholar 

  7. Heneghan C, Ward A, Perera R, Bankhead C, Fuller A, Stevens R, Bradford K, Tyndel S, Alonso-Coello P, Ansell J, Beyth R, Bernardo A, Christensen TD, Cromheecke ME, Edson RG, Fitzmaurice D, Gadisseur APA, Garcia-Alamino JM, Gardiner C, Hasenkam JM, Jacobson A, Kaatz S, Kamali F, Khan TI, Knight E, Körtke H, Levi M, Matchar D, Menéndez-Jándula B, Rakovac I, Schaefer C, Siebenhofer A, Souto JC, Sunderji R, Gin K, Shalansky K, Völler H, Wagner O, Zittermann A (2012) Self-monitoring of oral anticoagulation: systematic review and meta-analysis of individual patient data. Lancet 379:322–334. doi:10.1016/S0140-6736(11)61294-4

    Article  PubMed  Google Scholar 

  8. Garcia-Alamino JM, Ward AM, Alonso-Coello P, Perera R, Bankhead C, Fitzmaurice D, Heneghan CJ (2010) Self-monitoring and self-management of oral anticoagulation. Cochrane Database Syst Rev. doi:10.1002/14651858.CD003839.pub2

    PubMed  Google Scholar 

  9. Gallagher J, Mc Carthy S, Woods N, Ryan F, O’Shea S, Byrne S (2015) Economic evaluation of a randomized controlled trial of pharmacist-supervized patient self-testing of warfarin therapy. J Clin Pharm Ther 40:14–19. doi:10.1111/jcpt.12215

    Article  CAS  PubMed  Google Scholar 

  10. Gerkens S, Gailly J, Obyn C, Devriese S, Cleemput I (2012) Economic evaluation of the use of point-of-care devices in patients with long term oral anticoagulation. J. Thromb, Thrombolysis

    Google Scholar 

  11. Sharma P, Scotland G, Cruickshank M, Tassie E, Fraser C, Burton C, Croal B, Ramsay CR, 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 t. Health Technol Assess (Rockv) 19:1–172. doi:10.3310/hta19480

    Google Scholar 

  12. Dolor RJ, Ruybalid RL, Uyeda L, Edson RG, Phibbs C, Vertrees JE, Shih MC, Jacobson AK, Matchar DB (2010) An evaluation of patient self-testing competency of prothrombin time for managing anticoagulation: pre-randomization results of VA Cooperative Study #481-The Home INR Study (THINRS). J Thromb Thrombolysis. doi:10.1007/s11239-010-0499-8

    PubMed  Google Scholar 

  13. Menéndez-Jándula B (2005) Comparing self-management of oral anticoagulant therapy with clinic management. Ann Intern Med 142:1. doi:10.7326/0003-4819-142-1-200501040-00006

    Article  PubMed  Google Scholar 

  14. Rosendaal FR, Cannegieter SC, van der Meer FJ, Briët E (1993) A method to determine the optimal intensity of oral anticoagulant therapy. Thromb Haemost 69:236–239.

    CAS  PubMed  Google Scholar 

  15. Wan Y, Heneghan C, Perera R, Roberts N, Hollowell J, Glasziou P, Bankhead C, Xu Y (2008) Anticoagulation control and prediction of adverse events in patients with atrial fibrillation: a systematic review. Circ Cardiovasc Qual Outcomes 1:84–91. doi:10.1161/CIRCOUTCOMES.108.796185

    Article  PubMed  Google Scholar 

  16. Rose AJ, Hylek EM, Ozonoff A, Ash AS, Reisman JI, Berlowitz DR (2011) Risk-adjusted percent time in therapeutic range as a quality indicator for outpatient oral anticoagulation: results of the Veterans Affairs Study To Improve Anticoagulation (VARIA). Circ Cardiovasc Qual Outcomes 4:22–29. doi:10.1161/CIRCOUTCOMES.110.957738

    Article  PubMed  Google Scholar 

  17. Samsa G, Matchar DB, Dolor RJ, Wiklund I, Hedner E, Wygant G, Hauch O, Marple CB, Edwards R (2004) A new instrument for measuring anticoagulation-related quality of life: development and preliminary validation. Health Qual Life Outcomes 2:22. doi:10.1186/1477-7525-2-22

    Article  PubMed  PubMed Central  Google Scholar 

  18. Levi M, Hobbs FD, Jacobson A, Pisters R, Prisco D, Bernardo A, Haas M, Heidrich J, Rosenberg M, Nielsen J, Wuillemin W (2009) Improving antithrombotic management in patients with atrial fibrillation: current status and perspectives. Semin Thromb Hemost 35:527–542. doi:10.1055/s-0029-1240013

    Article  CAS  PubMed  Google Scholar 

  19. Hylek EM, Go AS, Chang Y, Jensvold NG, Henault LE, Selby JV, Singer DE (2003) Effect of intensity of oral anticoagulation on stroke severity and mortality in atrial fibrillation. N Engl J Med 349:1019–1026. doi:10.1056/NEJMoa022913

    Article  CAS  PubMed  Google Scholar 

  20. Kneeland PP, Fang MC (2010) Current issues in patient adherence and persistence: focus on anticoagulants for the treatment and prevention of thromboembolism. Patient Prefer Adherence 4:51–60. doi:10.2147/PPA.S6101

    PubMed  PubMed Central  Google Scholar 

  21. Garcia-Alamino JM, Martin J, Subirana M, Gich I (2002) Self management for oral anticoagulation. In: Garcia-Alamino JM (ed) The cochrane database of systematic reviews. Wiley, Chichester, p 2010

    Google Scholar 

  22. Matchar DB, Jacobson A, Dolor R, Edson R, Uyeda L, Phibbs CS, Vertrees JE, Shih M-C, Holodniy M, Lavori P (2010) Effect of home testing of international normalized ratio on clinical events. N Engl J Med 363:1608–1620. doi:10.1056/NEJMoa1002617

    Article  CAS  PubMed  Google Scholar 

  23. Money AG, Barnett J, Kuljis J, Duffin D (2015) Patient perceptions and expectations of an anticoagulation service: a quantitative comparison study of clinic-based testers and patient self-testers. Scand J Caring Sci. doi:10.1111/scs.12195

    PubMed  Google Scholar 

  24. Colella MP, Fiusa MML, Orsi FLA, de Paula EV, Annichino-Bizzacchi JM (2012) Performance of a point-of-care device in determining prothrombin time in an anticoagulation clinic. Blood Coagul Fibrinolysis 23:172–174. doi:10.1097/MBC.0b013e32835029bf

    Article  PubMed  Google Scholar 

  25. Hashimoto VAM, De Paula EV, Colella MP, Luz Fiusa MM, Montalvao SAL, Machado TFGS, Orsi FA, Annichino-Bizzacchi JM (2013) Performance of a point-of-care device in determining prothrombin time in supra-therapeutic INRs. Int J Lab Hematol 35:211–216. doi:10.1111/ijlh.12026

    Article  CAS  PubMed  Google Scholar 

  26. Plesch W, Wolf T, Breitenbeck N, Dikkeschei LD, Cervero A, Perez PL, van den Besselaar AMHP (2008) Results of the performance verification of the CoaguChek XS system. Thromb Res 123:381–389. doi:10.1016/j.thromres.2008.04.021

    Article  CAS  PubMed  Google Scholar 

  27. Torreiro EG, Fernández EG, Rodríguez RM, López CV, Núñez JB (2009) Comparative study of accuracy and clinical agreement of the CoaguChek XS portable device versus standard laboratory practice in unexperienced patients. Thromb Haemost 101:969–974. doi:10.1160/TH08-06-0379

    CAS  PubMed  Google Scholar 

  28. Plesch W, van den Besselaar AMHP (2009) Validation of the international normalized ratio (INR) in a new point-of-care system designed for home monitoring of oral anticoagulation therapy. Int J Lab Hematol 31:20–25. doi:10.1111/j.1751-553X.2007.00998.x

    Article  CAS  PubMed  Google Scholar 

  29. Lai YF, Kong MC, Chan FSL, Ng HJ (2015) Agreement of point-of-care INR test with standard venous sampling assay at higher extreme ranges. Ann Hematol 94:1407–1408. doi:10.1007/s00277-015-2371-6

    Article  CAS  PubMed  Google Scholar 

  30. Christensen TD, Larsen TB, Jensen C, Maegaard M, Sørensen B (2009) International normalised ratio (INR) measured on the CoaguChek S and XS compared with the laboratory for determination of precision and accuracy. Thromb Haemost 101:563–569. doi:10.1160/TH08-09-0601

    CAS  PubMed  Google Scholar 

  31. Fitzmaurice DA, Gardiner C, Kitchen S, Mackie I, Murray ET, Machin SJ (2005) An evidence-based review and guidelines for patient self-testing and management of oral anticoagulation. Br J Haematol 131:156–165. doi:10.1111/j.1365-2141.2005.05739.x

    Article  CAS  PubMed  Google Scholar 

  32. Ruff CT, Giugliano RP, Braunwald E, Hoffman EB, Deenadayalu N, Ezekowitz MD, Camm AJ, Weitz JI, Lewis BS, Parkhomenko A, Yamashita T, Antman EM (2014) Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet 383:955–962. doi:10.1016/S0140-6736(13)62343-0

    Article  CAS  PubMed  Google Scholar 

  33. Eikelboom JW, Connolly SJ, Brueckmann M, Granger CB, Kappetein AP, Mack MJ, Blatchford J, Devenny K, Friedman J, Guiver K, Harper R, Khder Y, Lobmeyer MT, Maas H, Voigt J, Simoons ML, Van de Werf F (2013) Dabigatran versus warfarin in patients with mechanical heart valves. N Engl J Med 369:1206–1214. doi:10.1056/NEJMoa1300615

    Article  CAS  PubMed  Google Scholar 

  34. Chen Q, Dong L, Dong Y, Zhao S, Fu B, Wang Y, Jiang H (2015) Security and cost comparison of INR self-testing and conventional hospital INR testing in patients with mechanical heart valve replacement. J Cardiothorac Surg 10:4. doi:10.1186/s13019-015-0205-1

    Article  PubMed  PubMed Central  Google Scholar 

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Authors and Affiliations

  1. Hematology and Hemotherapy Center, University of Campinas, Rua Carlos Chagas, 480, Cidade Universitária “Zeferino Vaz”, Campinas, SP, CEP: 13083-970, Brazil

    Sabrina da Silva Saraiva, Fernanda Andrade Orsi, Marcos Pereira Santos, Tania Machado, Silmara Montalvão, Carolina Costa-Lima, Erich Vinícius de Paula, Marina Pereira Colella & Joyce Annichino-Bizzacchi

  2. Department of Clinical Pathology, Faculty of Medical Sciences, University of Campinas, Rua Tessália Vieira de Camargo, 126. Cidade Universitária “Zeferino Vaz”, Campinas, SP, CEP: 13083-887, Brazil

    Fernanda Andrade Orsi

  3. Discipline of Hematology and Hemotherapy, Department of Clinical Medicine, Faculty of Medical Sciences, University of Campinas, Rua Tessália Vieira de Camargo, 126. Cidade Universitária “Zeferino Vaz”, Campinas, SP, CEP: 13083-887, Brazil

    Erich Vinícius de Paula & Joyce Annichino-Bizzacchi

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  1. Sabrina da Silva Saraiva
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Correspondence to Fernanda Andrade Orsi.

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da Silva Saraiva, S., Orsi, F.A., Santos, M.P. et al. Home management of INR in the public health system: feasibility of self-management of oral anticoagulation and long-term performance of individual POC devices in determining INR. J Thromb Thrombolysis 42, 146–153 (2016). https://doi.org/10.1007/s11239-016-1335-6

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