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Sharma P, Scotland G, Cruickshank M, et al. 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. Southampton (UK): NIHR Journals Library; 2015 Jun. (Health Technology Assessment, No. 19.48.)

Cover of 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

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.

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Appendix 5List of excluded studies with reasons for exclusion

Study design not a randomised controlled trial (n = 25)

Adedeji-Zakari S, Anthony VP, Honeywell M. The CoaguChek S system. U.S. Pharmacist 2007;32.

Ansell JE. Empowering patients to monitor and manage oral anticoagulation therapy. J Am Med Assoc 1999;281:182–3.

Ansell JE. Is self-management of oral anticoagulation a feasible and safe option? Nat Clin Pract Cardiovasc Med 2005;2:240–1.

Arellano-Rodrigo E. Home monitoring of warfarin effects. N Engl J Med 2011;364:378–9.

Bevan H, Giles M, Heads J, Parker V, Walters J. Point-of-care INR testing in cardiac wards. Aust Nurs J 2007;15:31.

Biss T, Avery PJ, Walsh PM, Kamali F. Warfarin treatment outcomes in children monitored at home with a point-of-care device. Thromb Haemost 2011;105:1103–5.

Coleman B, Patterson D, Long M, Farrell J. Setting quality standards for a community pharmacist-led anticoagulant clinic. Pharm J 2003;270:308–11.

Deom A, Reber G, Tsakiris DA, Hannes FM, Plesch W. Evaluation of the CoaguChek XS Plus system in a Swiss community setting. Thromb Haemost 2009;101:988–90.

Ferretti G, Giannarelli D, Carlini P, Felici A, Ciccarese M, Mandala M, et al. Self-monitoring versus standard monitoring of oral anticoagulation. Thromb Res 2007;119:389–90.

Fitzmaurice DA, Machin SJ. Recommendations for patients undertaking self management of oral anticoagulation. BMJ 2001;323:985–9.

Ford PW, Close A. Management of warfarin in atrial fibrillation. Med J Aust 2007;187:371.

Heidinger KS, Bernardo A, Taborski U, Muller-Berghaus G. Clinical outcome of self-management of oral anticoagulation in patients with atrial fibrillation or deep-vein thrombosis. Thromb Res 2000;98:287–93.

Herijgers P, Verhamme P. Improving the quality of anticoagulant therapy in patients with mechanical heart valves: what are we waiting for? Eur Heart J 2007;28:2424–6.

Kitchen S, Kitchen D, Jennings I, Woods T, Walker I. External quality assessment of CoaguChek point-of-care testing prothrombin time/international ratio monitors. Am J Clin Pathol 2008;129:825–6.

Kitchen S, Kitchen D, Jennings I, Woods T, Walker I. Quality assessment of CoaguChek point-of-care international normalized ratio monitors: a note of caution. Clin Chem 2007;53:1555–6.

Lippi G, Franchini M. Home monitoring of warfarin effects. N Engl J Med 2011;364:378–9.

Martin M. Home and community anticoagulation by GPs and patients. Br J Cardiol 1999;6:144–6.

Pluddemann A, Thompson M, Wolstenholme J, Price CP, Heneghan C. Point-of-care INR coagulometers for self-management of oral anticoagulation: primary care diagnostic technology update. Br J Gen Pract 2012;62:e798–800.

Rodgers G. Patient self-management of oral anticoagulation. Clin Adv Hematol Oncol 2005;3:94–5.

Stafford L, Peterson GM, Bereznicki LR, Jackson SL. A role for pharmacists in community-based post-discharge warfarin management: protocol for the ‘the role of community pharmacy in post hospital management of patients initiated on warfarin’ study. BMC Health Serv Res 2011;11:16.

Taborski U, Voller H, Kortke H, Blunt J, Wegscheider K. Self management of oral anticoagulation with the INRatio System: accuracy and reliability following a two-day structured training program. Lab Med 2004;35:303–7.

Thompson JL, Sundt TM, Sarano ME, Santrach PJ, Schaff HV. In-patient International Normalized Ratio self-testing instruction after mechanical heart valve implantation. Ann Thorac Surg 2008;85:46–50.

Williams MS. Long-term anticoagulation and home monitoring. Drug Benefit Trends 2000;12:15.

Williams VK, Griffiths ABM. Re: Acceptability of CoaguChek S and CoaguChek XS generated international normalised ratios against a laboratory standard in a paediatric setting: authors’ reply. Pathology 2008;40:438–9.

Zimmerman CR. The role of point-of-care anticoagulation monitoring in arterial and venous thromboembolic disorders. J Thromb Thrombolysis 2000;9:187–98.

Not self-management (n = 8)

Claes N, Buntinx F, Vijgen J, Arnout J, Vermylen J, Fieuws S, et al. The Belgian Improvement Study on Oral Anticoagulation Therapy: a randomized clinical trial. Eur Heart J 2005;26:2159–65.

Fitzmaurice DA, Hobbs FD, Murray ET, Bradley CP, Holder R. Evaluation of computerized decision support for oral anticoagulation management based in primary care. Br J Gen Pract 1996;46:533–5.

Jackson SL, Peterson GM, Vial JH, Jupe DM. Improving the outcomes of anticoagulation: an evaluation of home follow-up of warfarin initiation. J Intern Med 2004;256:137–44.

Lalonde L, Martineau J, Blais N, Montigny M, Ginsberg J, Fournier M, et al. Is long-term pharmacist-managed anticoagulation service efficient? A pragmatic randomized controlled trial. Am Heart J 2008;156:148–54.

Laurence C, Gialamas A, Yelland L, Bubner T, Ryan P, Willson K, et al. A pragmatic cluster randomised controlled trial to evaluate the safety, clinical effectiveness, cost-effectiveness and satisfaction with point-of-care testing in a general practice setting – rationale, design and baseline characteristics. Trials 2008;9:50.

Shiach CR, Campbell B, Poller L, Keown M, Chauhan N. Reliability of point-of-care prothrombin time testing in a community clinic: a randomized crossover comparison with hospital laboratory testing. Br J Haematol 2002;119:370–5.

Wilson SJ, Wells PS, Kovacs MJ, Lewis GM, Martin J, Burton E, et al. Comparing the quality of oral anticoagulant management by anticoagulation clinics and by family physicians: a randomized controlled trial. CMAJ 2003;169:293–8.

Woods K, Douketis JD, Schnurr T, Kinnon K, Powers P, Crowther MA. Patient preferences for capillary vs. venous INR determination in an anticoagulation clinic: a randomized controlled trial. Thromb Res 2004;114:161–5.

Self-management dosage studies (n = 4)

Koertke H, Zittermann A, Wagner O, Ennker J, Saggau W, Sack FU, et al. Efficacy and safety of very low-dose self-management of oral anticoagulation in patients with mechanical heart valve replacement. Ann Thorac Surg 2010;90:1487–93.

Kortke H, Secer S. Telemedical based thrombosis service of patients with mechanical heart valve replacement. Vasa 2012;41(Suppl. 82):25.

Koertke H, Minami K, Boethig D, Breymann T, Seifert D, Wagner O, et al. INR self-management permits lower anticoagulation levels after mechanical heart valve replacement. Circulation 2003;108(Suppl. 1):II75–8.

Koertke H, Zittermann A, Tenderich G, Wagner O, El-Arousy M, Krian A, et al. Low-dose oral anticoagulation in patients with mechanical heart valve prostheses: final report from the early self-management anticoagulation trial II. Eur Heart J 2007;28:2479–84

Excluded tests (n = 3)

Beyth RJ, Quinn L, Landefeld CS. A multicomponent intervention to prevent major bleeding complications in older patients receiving warfarin. A randomised, controlled trial. Ann Intern Med 2000;133:687–95.

Grunau BE, Wiens MO, Harder KK. Patient self-management of warfarin therapy: pragmatic feasibility study in Canadian primary care. Can Fam Physician 2011;57:e292–8.

White RH, McCurdy SA, Marensdorff H, Woodruff DE, Leftgoff L. Home prothrombin time monitoring after the initiation of warfarin therapy. A randomised, prospective study. Ann Intern Med 1989;111:730–7.

Background information (n = 25)

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.

Bussey HI. Transforming oral anticoagulation by combining international normalised ratio (INR) self-testing and online automated management. J Thromb Thrombolysis 2011;31:265–74.

Cayley J. Self-monitoring and self-management of anticoagulation therapy. Am Fam Physician 2011;84:266–8.

Christensen TD, Larsen TB. Precision and accuracy of point-of-care testing coagulometers used for self-testing and self-management of oral anticoagulation therapy. J Thromb Haemost 2012;10:251–60.

Christensen TD, Johnsen SP, Hjortdal VE, Hasenkam JM. Self-management of oral anticoagulant therapy: a systematic review and meta-analysis. Int J Cardiol 2007;118:54–61.

Christensen TD. Self-management of oral anticoagulation therapy--methodological and clinical aspects. Dan Med Bull 2011;58:B4284.

Connock M, Stevens C, Fry-Smith A, Jowett S, Fitzmaurice D, Moore D, et al. Clinical effectiveness and cost-effectiveness of different models of managing long-term oral anticoagulation therapy: a systematic review and economic modelling. Health Technol Assess 2007;11(38).

Dolan G, Smith LA, Collins S, Plumb JM. Effect of setting, monitoring intensity and patient experience on anticoagulation control: a systematic review and meta-analysis of the literature. Curr Med Res Opin 2008;24:1459–72.

Dolor RJ, Ruybalid RL, Uyeda L, Edson RG, Phibbs C, Vertrees, JE et al. An evaluation of patient self-testing competency of prothrombin time for managing anticoagulation: pre-randomisation results of VA Cooperative Study #481 – The Home INR Study (THINRS). J Thromb Thrombolysis 2010;30:263–75.

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.

Health Q. Point-of-care international normalized ratio (INR) monitoring devices for patients on long-term oral anticoagulation therapy: an evidence-based analysis. Ontario Health Technol Assess Series 2009;9:1–114.

Heneghan C, Ward A, Perera R, Self-Monitoring Triallist collaboration, Bankhead C, Fuller A, et al. Self-monitoring of oral anticoagulation: systematic review and meta-analysis of individual patient data. Lancet 2012; 379:322–34. [Erratum published in. Lancet 2012;379:1102.]

Holbrook A, Schulman S, Witt DM, Vandvik PO, Fish J, Kovacs MJ, et al. 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 2012;141:e152S–84S.

Jennings I, Walker ID, Kitchen S, Kitchen D, Woods TA, Keeling D, et al. Management of patients receiving oral anticoagulants using computer dosing software--does everyone agree? Data from a UK NEQAS (blood coagulation) exercise. Int J Lab Haematol 2012;34:70–80.

Mazor KM, Baril J, Dugan E, Spencer F, Burgwinkle P, Gurwitz JH. Patient education about anticoagulant medication: is narrative evidence or statistical evidence more effective? Patient Educ Couns 2007;69:145–57.

Murray ET, Jennings I, Kitchen D, Kitchen S, Fitzmaurice DA. Quality assurance for oral anticoagulation self-management: a cluster randomized trial. J Thromb Haemost 2008;6:464–9.

Newall F, Bauman M. Point-of-care antithrombotic monitoring in children. Thromb Res 2006;118:113–21.

Nieuwlaat R, Barker L, Kim YK, Haynes RB, Eikelboom JW, Yusuf S, et al. Underuse of evidence-based warfarin dosing methods for atrial fibrillation patients. Thromb Res 2010;125:e128–31.

Perera R, Heneghan C, Fitzmaurice D, Self M. Individual patient meta-analysis of self-monitoring of an oral anticoagulation protocol. J Heart Valve Dis 2008;17:233–8.

Shermock KM, Streiff MB, Pinto BL, Kraus P, Pronovost PJ. Novel analysis of clinically relevant diagnostic errors in point-of-care devices. J Thromb Haemost 2011;9:1769–75.

Spinler SA, Nutescu EA, Smythe MA, Wittkowsky AK. Anticoagulation monitoring part 1: warfarin parenteral direct thrombin inhibitors. Ann Pharmacother 2005;39:1049–55.

Stigendal L, Andre U. Workshop: Patient self-management: update of ongoing studies in Sweden. J Thromb Thrombolysis 1998;5:S63–4.

Völler H, Dovifat C, Glatz J, Kortke H, Taborski U, Wegscheider K. Self management of oral anticoagulation with the IN Ratio system: impact of a structured teaching program on patient’s knowledge of medical background and procedures. Eur J Cardiovasc Prev Rehabil 2004;11:442–7.

Wilds D, Murray M, Shakespeare A, Reaney M, von M. Patient-reported treatment satisfaction measures for long-term anticoagulant therapy. Expert Rev Pharmacoeconomics Outcomes Res 2008;8:291–9.

Xu Z, Wang Z, Ou J, Xu Y, Yang S, Zhang X. Two monitoring methods of oral anticoagulant therapy in patients with mechanical heart valve prothesis: a meta-analysis. J Thromb Thrombolysis 2012;33:38–47.

Accuracy of CoaguChek XS versus S (n = 10)

Braun S, Watzke H, Hasenkam JM, Schwab M, Wolf T, Dovifat C, 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;97:310–14.

Christensen TD, Larsen TB, Jensen C, Maegaard M, Sorensen B. International normalised ratio (INR) measured on the CoaguChek S and XS compared with the laboratory for determination of precision and accuracy. Thromb Haemost 2009;101:563–9.

Karon BS, McBane RD, Chaudhry R, Beyer LK, Santrach PJ. Accuracy of capillary whole blood international normalized ratio on the CoaguChek S, CoaguChek XS, and i-STAT 1 point-of-care analyzers. Am J Clin Pathol 2008;130:88–92.

Kong MC, Lim TG, Ng HJ, Chan YH, Lee LH. Feasibility, cost-effectiveness and patients’ acceptance of point-of-care INR testing in a hospital-based anticoagulation clinic. Ann Hematol 2008;87:905–10.

Paioni P, Kroiss S, Kagi E, Bergstrasser E, Fasnacht M, Bauersfeld U, et al. Self-monitoring of oral anticoagulation therapy in children. Acta Haematol 2009;122:58–63.

Poller L. Precision and accuracy of CoaguChek S and XS monitors: the need for external quality assessment. Thrombo Haemost 2009;101:419–21.

Reverdin S, Schnetzler B, Gagneux G, Gavignet C, Boehlen F, De Moerloose P. Implementation of an INR self-testing and self-management programme in common ambulatory private practice: our experience with 90 patients. Swiss Med Wkly 2011;141:w13199.

Ryan F, O’Shea S, Byrne S. The reliability of point-of-care prothrombin time testing. A comparison of CoaguChek S and XS INR measurements with hospital laboratory monitoring. Int J Lab Hematol 2010;32:e26–33.

Sobieraj-Teague M, Daniel D, Farrelly B, Coghlan D, Gallus A. Accuracy and clinical usefulness of the CoaguChek S and XS Point-of-care devices when starting warfarin in a hospital outreach setting. Thromb Res 2009;123:909–13.

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;39:575–9.

Copyright © Queen’s Printer and Controller of HMSO 2015. This work was produced by Sharma et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.

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Bookshelf ID: NBK304000

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