Self-testing and self-management of oral anticoagulation therapy in children

 

 Buy Article Permissions and Reprints

Summary

Children and adolescents on oral anticoagulation therapy (OAT) present special challenges in terms of rapid fluctuations in International Normalised Ratio (INR) values, interruption in daily life due to frequent hospital/doctor visits, and difficulties and pain in the performance of venepuncture. Optimised management of OAT improves the quality of treatment, potentially accomplished by new methods such as patient self-testing (PST) and patient self-management (PSM). A review was performed, identifying 11 trials with children and adolescents. All studies had different methodological problems, predominantly by being non-randomised trials. A total of 284 patients were included with a mean follow-up of 22 months, finding a time within therapeutic INR target range between 63% and 84%. The coagulometers used for estimating the INR values were found to have sufficient precision and accuracy for clinical use, but external quality control is probably advisable. It can be concluded that PST and PSM are at least as good treatment options as conventional management in highly selected children. Larger studies, preferably randomised, controlled trials using clinical endpoints, are obviously needed in order to elucidate whether these new regimens of treatment are superior to conventional management of oral anticoagulation therapy.

• References

• 1 Ansell J, Hirsh J, Hylek E. et al. Pharmacology and management of the vitamin K antagonists: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 2008; 133: 160S-198S.
  CrossrefPubMedGoogle Scholar
• 2 Andrew M. Indications and drugs for anticoagulation therapy in children. Thromb Res 1996; 81: S61-S73.
  CrossrefPubMedGoogle Scholar
• 3 Marzinotto V, Monagle P, Chan A. et al. Capillary whole blood monitoring of oral anticoagulants in children in outpatient clinics and the home setting. Pediatr Cardiol 2000; 21: 347-352.
  CrossrefPubMedGoogle Scholar
• 4 Mähönen S, Riikonen P, Vaatainen RL. et al. Oral anticoagulant treatment in children based on monitoring at home. Acta Paediatr 2004; 93: 687-691.
  CrossrefPubMedGoogle Scholar
• 5 Bauman ME, Conroy S, Massicotte MP. Point-of-care INR measurements in children requiring warfarin: what has been evaluated and future directions. Pediatric Health 2008; 2: 651-659.
  CrossrefPubMedGoogle Scholar
• 6 Kearon C, Ginsberg JS, Kovacs MJ. et al. Comparison of low-intensity warfarin therapy with conventional-intensity warfarin therapy for long-term prevention of recurrent venous thromboembolism. N Engl J Med 2003; 349: 631-639.
  CrossrefPubMedGoogle Scholar
• 7 Lindh JD, Holm L, Dahl ML. et al. Incidence and predictors of severe bleeding during warfarin treatment. J Thromb Thrombolysis 2008; 25: 151-159.
  CrossrefPubMedGoogle Scholar
• 8 Sönksen PH, Judd SL, Lowy C. Home monitoring of blood-glucose. Method for improving diabetic control. Lancet 1978; 1: 729-732.
  PubMedGoogle Scholar
• 9 Thompson JL, Sundt TM, Sarano ME. et al. In-patient international normalized ratio self-testing instruction after mechanical heart valve implantation. Ann Thorac Surg 2008; 85: 2046-2050.
  CrossrefPubMedGoogle Scholar
• 10 Garcia-Alamino JM, Ward AM, Alonso-Coello P. et al. Self-monitoring and self-management of oral anticoagulation. Cochrane Database Syst Rev 2010; 4: CD003839.
  PubMedGoogle Scholar
• 11 Andrew M, Marzinotto V, Brooker LA. et al. Oral anticoagulation therapy in pediatric patients: a prospective study. Thromb Haemost 1994; 71: 265-269.
  Article in Thieme ConnectPubMedGoogle Scholar
• 12 Van LY, Rosendaal FR, Cannegieter SC. Prediction of hemorrhagic and thrombotic events in patients with mechanical heart valve prostheses treated with oral anticoagulants. J Thromb Haemost 2008; 6: 451-456.
  CrossrefPubMedGoogle Scholar
• 13 Bauman ME, Black K, Bauman ML. et al. EMPoWarMENT: Edmonton Pediatric Warfarin Self-Management Pilot Study in Children with Primarily Cardiac Disease. Thromb Res 2010; 126: e110-e115.
  CrossrefPubMedGoogle Scholar
• 14 Jones S, Newall F, Manias E. et al. Assessing outcome measures of oral anticoagulation management in children. Thromb Res 2011; 127: 75-80.
  CrossrefPubMedGoogle Scholar
• 15 Bruce AA, Bauman ME, Black K. et al. Development and preliminary evaluation of the KIDCLOT PAC QL: a new health-related quality of life measure for pediatric long-term anticoagulation therapy. Thromb Res 2010; 126: e116-e121.
  CrossrefPubMedGoogle Scholar
• 16 Massicotte P, Marzinotto V, Vegh P. et al. Home monitoring of warfarin therapy in children with a whole blood prothrombin time monitor. J Pediatr 1995; 127: 389-394.
  CrossrefPubMedGoogle Scholar
• 17 Christensen TD, Attermann J, Hjortdal VE, Maegaard M, Hasenkam JM. Self-management of oral anticoagulation in children with congenital heart disease. Cardiol Young 2001; 11: 269-276.
  CrossrefPubMedGoogle Scholar
• 18 Günther T, Mazzitelli D, Schreiber C. et al. Mitral-valve replacement in children under 6 years of age. Eur J Cardiothorac Surg 2000; 17: 426-430.
  CrossrefPubMedGoogle Scholar
• 19 Nowatzke WL, Landt M, Smith C. et al. Whole blood international normalization ratio measurements in children using near-patient monitors. J Pediatr Hematol Oncol 2003; 25: 33-37.
  CrossrefPubMedGoogle Scholar
• 20 Newall F, Monagle P, Johnston L. Home INR monitoring of oral anticoagulant therapy in children using the CoaguChek S point-of-care monitor and a robust education program. Thromb Res 2006; 118: 587-593.
  CrossrefPubMedGoogle Scholar
• 21 Reiss N, Blanz U, Breymann T. et al. Mechanical valve replacement of the systemic atrioventricular valve in children. ASAIO J 2006; 52: 559-561.
  PubMedGoogle Scholar
• 22 Christensen TD, Andersen NT, Maegaard M. et al. Oral anticoagulation therapy in children: successfully controlled by self-management. Heart Surg Forum 2004; 7: E321-E325.
  CrossrefPubMedGoogle Scholar
• 23 Bauman ME, Black K, Kuhle S. et al. KIDCLOT: the importance of validated educational intervention for optimal long term warfarin management in children. Thromb Res 2009; 123: 707-709.
  CrossrefPubMedGoogle Scholar
• 24 Reiss N, Blanz U, Bairaktaris H. et al. Mechanical valve replacement in congenital heart defects in the era of international normalized ratio self-management. ASAIO J 2005; 51: 530-532.
  CrossrefPubMedGoogle Scholar
• 25 Newall F, Monagle P, Johnston L. Patient understanding of warfarin therapy: a review of education strategies. Hematology 2005; 10: 437-442.
  CrossrefPubMedGoogle Scholar
• 26 Paioni P, Kroiss S, Kagi E. et al. Self-monitoring of oral anticoagulation therapy in children. Acta Haematol 2009; 122: 58-63.
  CrossrefPubMedGoogle Scholar
• 27 Christensen TD. Self-management of oral anticoagulant therapy: a review. J Thromb Thrombolysis 2004; 18: 127-143.
  CrossrefPubMedGoogle Scholar
• 28 Braun S, Watzke H, Hasenkam JM. et al. Performance evaluation of the new CoaguChek XS system compared with the established CoaguChek system by patients experienced in INR-self management. Thromb Haemost 2007; 97: 310-314.
  Article in Thieme ConnectPubMedGoogle Scholar
• 29 Williams VK, Griffiths AB. Acceptability of CoaguChek S and CoaguChek XS generated international normalised ratios against a laboratory standard in a paediatric setting. Pathology 2007; 39: 575-579.
  CrossrefPubMedGoogle Scholar
• 30 Bauman ME, Black KL, Massicotte MP. et al. Accuracy of the CoaguChek XS for point-of-care international normalized ratio (INR) measurement in children requiring warfarin. Thromb Haemost 2008; 99: 1097-1103.
  Article in Thieme ConnectPubMedGoogle Scholar
• 31 Greenway A, Ignjatovic V, Summerhayes R. et al. Point-of-care monitoring of oral anticoagulation therapy in children. Comparison of the CoaguChek XS system with venous INR and venous INR using an International Reference Thromboplastin preparation (rTF/95). Thromb Haemost 2009; 102: 159-165.
  Article in Thieme ConnectPubMedGoogle Scholar
• 32 Ignjatovic V, Barnes C, Newall F. et al. Point of care monitoring of oral anticoagulant therapy in children: comparison of CoaguChek Plus and Thrombotest methods with venous international normalised ratio. Thromb Haemost 2004; 92: 734-737.
  Article in Thieme ConnectPubMedGoogle Scholar
• 33 Newall F, Bauman M. Point-of-care antithrombotic monitoring in children. Thromb Res 2006; 118: 113-121.
  CrossrefPubMedGoogle Scholar
• 34 Van den Besselaar AM, Barrowcliffe TW, Houbouyan-Reveillard LL. et al. Guidelines on preparation, certification, and use of certified plasmas for ISI calibration and INR determination. J Thromb Haemost 2004; 2: 1946-1953.
  CrossrefPubMedGoogle Scholar
• 35 Christensen TD, Larsen TB, Jensen C. et al. International normalised ratio (INR) measured on the CoaguChek S and XS compared with the laboratory for determination of precision and accuracy. Thromb Haemost 2009; 101: 563-569.
  Article in Thieme ConnectPubMedGoogle Scholar
• 36 Murray ET, Jennings I, Kitchen D. et al. Quality assurance for oral anticoagulation self management: a cluster randomized trial. J Thromb Haemost 2008; 6: 464-469.
  CrossrefPubMedGoogle Scholar
• 37 Poller L, Keown M, Ibrahim SA. et al. Quality assessment of CoaguChek point-of-care prothrombin time monitors: comparison of the European community-approved procedure and conventional external quality assessment. Clin Chem 2006; 52: 1843-1847.
  CrossrefPubMedGoogle Scholar
• 38 Solvik UO, Stavelin A, Christensen NG. et al. 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: 337-349.
  CrossrefPubMedGoogle Scholar
• 39 Jespersen J, Poller L, Van den Besselaar AM. et al. External quality assessment (EQA) for CoaguChek monitors. Thromb Haemost 2010; 103: 936-941.
  Article in Thieme ConnectPubMedGoogle Scholar
• 40 Poller L. Precision and accuracy of CoaguChek S and XS monitors: The need for external quality assessment. Thromb Haemost 2009; 101: 419-421.
  Article in Thieme ConnectPubMedGoogle Scholar
• 41 Salvador CH, Ruiz-Sanchez A, Gonzalez de Mingo MA. et al. Evaluation of a tele-medicine-based service for the follow-up and monitoring of patients treated with oral anticoagulant therapy. IEEE Trans Inf Technol Biomed 2008; 12: 696-706.
  CrossrefPubMedGoogle Scholar
• 42 Oake N, van WC, Rodger MA, Forster AJ. Effect of an interactive voice response system on oral anticoagulant management. CMAJ 2009; 180: 927-933.
  CrossrefPubMedGoogle Scholar
• 43 Connolly SJ, Ezekowitz MD, Yusuf S. et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009 361: 1139-1151
  PubMedGoogle Scholar