Thromb Haemost 2022; 122(04): 492-505
DOI: 10.1055/a-1677-9608
Coagulation and Fibrinolysis

Clinical Outcomes of Different Warfarin Self-Care Strategies: A Systematic Review and Network Meta-Analysis

1   Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand
,
Kansak Boonpattharatthiti
1   Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand
2   Division of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Burapha University, Chon Buri, Thailand
,
Treeluck Thammathuros
1   Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand
,
Piyameth Dilokthornsakul
3   Department of Pharmacy Practice, Center of Pharmaceutical Outcomes Research, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand
,
Itsarawan Sakunrag
1   Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand
,
Beth Devine
4   The Comparative Health Outcomes, Policy, and Economics Institute, School of Pharmacy, University of Washington, Seattle, Washington, United States
› Institutsangaben
Funding This study received financial support from Naresuan University's Faculty of Pharmaceutical Sciences Research Fund.

Abstract

Aim To compare the effects of different strategies for warfarin self-care.

Methods PubMed, EMBASE, CENTRAL, CINAHL, ProQuest Dissertations & Theses, and OpenGrey were searched from inception to August 2021. Randomized controlled trials (RCTs) of warfarin self-care, either patient self-testing (PST) or patient self-management (PSM), were included. Self-care approaches were classified based on the TIP framework (theme, intensity, provider): (1) PST ≥1/week via e-Health (PST/High/e-Health); (2) PST ≥1/week by health care practitioner (PST/High/HCP); (3) PST <1/week via e-Health (PST/Low/e-Health); (4) PSM ≥1/week by e-Health (PSM/High/e-Health); (5) PSM ≥1/week by patient (PSM/High/Pt); (6) PSM <1/week by patient (PSM/Low/Pt); and (7) PSM with flexible frequency by patient (PSM/Flex/Pt). Mean differences (MDs) and risk ratios (RRs) with 95% confidence interval (CI) were estimated using frequentist network meta-analyses with a random-effects model. The certainty of evidence was evaluated using CINeMA (Confidence in Network Meta-Analysis).

Results Sixteen RCTs involving 5,895 participants were included. When compared with usual care, time in therapeutic range was higher in PSM/High/Pt and PST/High/e-Health with MD [95% CI] of 7.67% [0.26–15.08] and 5.65% [0.04–11.26], respectively. The certainty of evidence was rated as moderate for these findings. The risk of thromboembolic events was lower in the PSM/Flex/Pt group when compared with PST/High/e-Health (RR: 0.39 [0.20–0.77]) and usual care (RR: 0.38 [0.17–0.88]) with low and very low level of evidence, respectively. There was no significant difference in the proportion of international normalized ratio (INR) values in range, major bleeding, and all-cause mortality among different self-care features.

Conclusion Patient self-care (either PST or PSM) by measuring INR values at least once weekly is more effective in controlling the INR level.

Supplementary Material



Publikationsverlauf

Eingereicht: 23. Juni 2021

Angenommen: 20. Oktober 2021

Accepted Manuscript online:
25. Oktober 2021

Artikel online veröffentlicht:
20. Januar 2022

© 2021. Thieme. All rights reserved.

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

 
  • References

  • 1 Otto CM, Nishimura RA, Bonow RO. et al. 2020 ACC/AHA guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation 2021; 143 (05) e72-e227
  • 2 Ageno W, Gallus AS, Wittkowsky A, Crowther M, Hylek EM, Palareti G. Oral Anticoagulant Therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141 (2 Suppl): e44S-e88S
  • 3 Wilson SJ, Wells PS, Kovacs MJ. et al. Comparing the quality of oral anticoagulant management by anticoagulation clinics and by family physicians: a randomized controlled trial. CMAJ 2003; 169 (04) 293-298
  • 4 van Walraven C, Jennings A, Oake N, Fergusson D, Forster AJ. Effect of study setting on anticoagulation control: a systematic review and metaregression. Chest 2006; 129 (05) 1155-1166
  • 5 Sakunrag I, Danwilai K, Dilokthornsakul P, Chaiyakunapruk N, Dhippayom T. Clinical outcomes of telephone service for patients on warfarin: a systematic review and meta-analysis. Telemed J E Health 2020; 26 (12) 1507-1521
  • 6 Siebenhofer A, Berghold A, Sawicki PT. Systematic review of studies of self-management of oral anticoagulation. Thromb Haemost 2004; 91 (02) 225-232
  • 7 Keeling D, Baglin T, Tait C. et al. Guidelines on oral anticoagulation with warfarin - fourth edition. Br J Haematol 2011; 154: 311-324
  • 8 Sharma P, Scotland G, Cruickshank M. 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 (06) e007758
  • 9 Heneghan CJ, Garcia-Alamino JM, Spencer EA. et al. Self-monitoring and self-management of oral anticoagulation. Cochrane Database Syst Rev 2016; 7: CD003839
  • 10 Bloomfield HE, Krause A, Greer N. 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 (07) 472-482
  • 11 Higgins JPT, Green S. eds. Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]: The Cochrane Collaboration. 2011 [cited 2019 Aug 13]. Accessed November 18, 2021 at: http://handbook-5-1.cochrane.org/
  • 12 Hutton B, Salanti G, Caldwell DM. et al. The PRISMA extension statement for reporting of systematic reviews incorporating network meta-analyses of health care interventions: checklist and explanations. Ann Intern Med 2015; 162 (11) 777-784
  • 13 Cochrane Effective Practice and Organisation of Care. Good practice data extraction form [Internet]. Oxford: Cochrane Effective Practice and Organisation of Care (EPOC); 2020 . [cited 2020 Oct 15]; Accessed November 18, 2021 at: https://epoc.cochrane.org/sites/epoc.cochrane.org/files/public/uploads/Resources-for-authors2017/good_practice_data_extraction_form.doc
  • 14 Dhippayom T, Wateemongkollert A, Mueangfa K, Im H, Dilokthornsakul P, Devine B. Comparative efficacy of strategies to support self-management in patients with asthma: a systematic review and network meta-analysis. J Allergy Clin Immunol Pract 2021; DOI: 10.1016/j.jaip.2021.09.049.
  • 15 Cochrane Effective Practice and Organisation of Care. Summary assessments of the risk of bias. EPOC resources for review authors [Internet]. 2020 . [cited 2020 Oct 15]; Accessed November 18, 2021 at: https://epoc.cochrane.org/resources/epoc-resources-review-authors
  • 16 Liu Y, Wang W, Zhang AB, Bai X, Zhang S. Epley and Semont maneuvers for posterior canal benign paroxysmal positional vertigo: a network meta-analysis. Laryngoscope 2016; 126 (04) 951-955
  • 17 Dias S, Welton NJ, Caldwell DM, Ades AE. Checking consistency in mixed treatment comparison meta-analysis. Stat Med 2010; 29 (7–8): 932-944
  • 18 Salanti G. Indirect and mixed-treatment comparison, network, or multiple-treatments meta-analysis: many names, many benefits, many concerns for the next generation evidence synthesis tool. Res Synth Methods 2012; 3 (02) 80-97
  • 19 Chaimani A, Higgins JP, Mavridis D, Spyridonos P, Salanti G. Graphical tools for network meta-analysis in STATA. PLoS One 2013; 8 (10) e76654
  • 20 Nikolakopoulou A, Higgins JPT, Papakonstantinou T. et al. CINeMA: an approach for assessing confidence in the results of a network meta-analysis. PLoS Med 2020; 17 (04) e1003082
  • 21 Brasen CL, Madsen JS, Parkner T, Brandslund I. Home management of warfarin treatment through a real-time supervised telemedicine solution: a randomized controlled trial. Telemed J E Health 2019; 25 (02) 109-115
  • 22 Christensen H, Lauterlein JJ, Sørensen PD, Petersen ER, Madsen JS, Brandslund I. Home management of oral anticoagulation via telemedicine versus conventional hospital-based treatment. Telemed J E Health 2011; 17 (03) 169-176
  • 23 Dignan R, Keech AC, Gebski VJ, Mann KP, Hughes CF. Warfarin SMART Investigators. Is home warfarin self-management effective? Results of the randomised self-management of anticoagulation research trial. Int J Cardiol 2013; 168 (06) 5378-5384
  • 24 Eitz T, Schenk S, Fritzsche D. et al. International normalized ratio self-management lowers the risk of thromboembolic events after prosthetic heart valve replacement. Ann Thorac Surg 2008; 85 (03) 949-954
  • 25 Fitzmaurice DA, Murray ET, Gee KM, Allan TF, Hobbs FD. A randomised controlled trial of patient self management of oral anticoagulation treatment compared with primary care management. J Clin Pathol 2002; 55 (11) 845-849
  • 26 Fitzmaurice DA, Murray ET, McCahon D. et al. Self management of oral anticoagulation: randomised trial. BMJ 2005; 331 (7524): 1057
  • 27 Gardiner C, Williams K, Longair I, Mackie IJ, Machin SJ, Cohen H. A randomised control trial of patient self-management of oral anticoagulation compared with patient self-testing. Br J Haematol 2006; 132 (05) 598-603
  • 28 Khan TI, Kamali F, Kesteven P, Avery P, Wynne H. The value of education and self-monitoring in the management of warfarin therapy in older patients with unstable control of anticoagulation. Br J Haematol 2004; 126 (04) 557-564
  • 29 Matchar DB, Jacobson A, Dolor R. et al; THINRS Executive Committee and Site Investigators. Effect of home testing of international normalized ratio on clinical events. N Engl J Med 2010; 363 (17) 1608-1620
  • 30 Rasmussen RS, Corell P, Madsen P, Overgaard K. Effects of computer-assisted oral anticoagulant therapy. Thromb J 2012; 10 (01) 17
  • 31 Ryan F, Byrne S, O'Shea S. Randomized controlled trial of supervised patient self-testing of warfarin therapy using an internet-based expert system. J Thromb Haemost 2009; 7 (08) 1284-1290
  • 32 Sidhu P, O'Kane HO. Self-managed anticoagulation: results from a two-year prospective randomized trial with heart valve patients. Ann Thorac Surg 2001; 72 (05) 1523-1527
  • 33 Sunderji R, Gin K, Shalansky K. et al. A randomized trial of patient self-managed versus physician-managed oral anticoagulation. Can J Cardiol 2004; 20 (11) 1117-1123
  • 34 Thompson JL, Burkhart HM, Daly RC. et al. Anticoagulation early after mechanical valve replacement: improved management with patient self-testing. J Thorac Cardiovasc Surg 2013; 146 (03) 599-604
  • 35 Verret L, Couturier J, Rozon A. et al. Impact of a pharmacist-led warfarin self-management program on quality of life and anticoagulation control: a randomized trial. Pharmacotherapy 2012; 32 (10) 871-879
  • 36 Yıldırım JG, Bayık Temel A. The effect of nurse home-support program on self-management of patients receiving oral anticoagulation (warfarin) therapy. Florence Nightingale J Nurs 2020; 28 (01) 13-22
  • 37 Blissit KT, Mullenix ML, Brittain KG. Evaluation of time in therapeutic range on warfarin therapy between face-to-face and telephone follow-up in a VA medical center. J Pharm Technol 2015; 31: 78-83
  • 38 Jonkman NH, Schuurmans MJ, Jaarsma T, Shortridge-Baggett LM, Hoes AW, Trappenburg JC. Self-management interventions: proposal and validation of a new operational definition. J Clin Epidemiol 2016; 80: 34-42
  • 39 Lee CH, Chang BY. Effect of disease improvement with self-measurement compliance (measurement frequency level) in SmartCare hypertension management service. Telemed J E Health 2016; 22 (03) 238-245
  • 40 Xu Y, Tan DHY, Lee JY. Evaluating the impact of self-monitoring of blood glucose frequencies on glucose control in patients with type 2 diabetes who do not use insulin: a systematic review and meta-analysis. Int J Clin Pract 2019; 73 (07) e13357
  • 41 Welch G, Balder A, Zagarins S. Telehealth program for type 2 diabetes: usability, satisfaction, and clinical usefulness in an urban community health center. Telemed J E Health 2015; 21 (05) 395-403
  • 42 Lancaster K, Abuzour A, Khaira M. et al. The use and effects of electronic health tools for patient self-monitoring and reporting of outcomes following medication use: systematic review. J Med Internet Res 2018; 20 (12) e294
  • 43 Phillips KW, Ansell J. Outpatient management of oral vitamin K antagonist therapy: defining and measuring high-quality management. Expert Rev Cardiovasc Ther 2008; 6 (01) 57-70
  • 44 Nguyen VN, Stevens CA, Brambatti M. et al. Improved time in therapeutic range with international normalized ratio remote monitoring for patients with left ventricular assist devices. ASAIO J 2021
  • 45 Vestergaard AS, Skjøth F, Larsen TB, Ehlers LH. The importance of mean time in therapeutic range for complication rates in warfarin therapy of patients with atrial fibrillation: a systematic review and meta-regression analysis. PLoS One 2017; 12 (11) e0188482
  • 46 Havers-Borgersen E, Butt JH, Vinding NE. et al. Time in therapeutic range and risk of thromboembolism and bleeding in patients with a mechanical heart valve prosthesis. J Thorac Cardiovasc Surg 2019; DOI: 10.1016/j.jtcvs.2019.02.061.
  • 47 Siddiqui S, DeRemer CE, Waller JL, Gujral JS. Variability in the calculation of time in therapeutic range for the quality control measurement of warfarin. J Innov Card Rhythm Manag 2018; 9 (12) 3428-3434
  • 48 Jensen CF, Christensen TD, Maegaard M, Hasenkam JM. Quality of oral anticoagulant therapy in patients who perform self management: warfarin versus phenprocoumon. J Thromb Thrombolysis 2009; 28 (03) 276-281
  • 49 Cromheecke ME, Levi M, Colly LP. et al. Oral anticoagulation self-management and management by a specialist anticoagulation clinic: a randomised cross-over comparison. Lancet 2000; 356 (9224): 97-102
  • 50 Cayley Jr WE. Self-monitoring and self-management of oral anticoagulation. Am Fam Physician 2017; 95 (11) 700-701