Systematic review of studies of self-management of oral anticoagulation

Andrea Siebenhofer; Andrea Berghold; Peter T. Sawicki

doi:10.1160/TH03-09-0598

Thrombosis and Haemostasis, Table of Contents

Thromb Haemost 2004; 91(02): 225-232
DOI: 10.1160/TH03-09-0598

Review Article

Schattauer GmbH

Systematic review of studies of self-management of oral anticoagulation

Andrea Siebenhofer

¹Department of Internal Medicine, Division of Diabetes and Metabolism, Karl-Franzens University Hospital, Graz, Austria

,

Andrea Berghold

²Institute for Medical Informatics, Statistics and Documentation, Karl-Franzens University, Graz, Austria

,

Peter T. Sawicki

³Department of Internal Medicine, St. Franziskus Hospital and Institute for Evidence based Medicine, Cologne, Germany

› Author Affiliations

Abstract

Summary

This work is aimed at assessing the evidence for the possible improvement of therapeutic control of anticoagulation, reduction of major bleedings, thromboembolism and improvement of treatment-related quality of life in patients with self-managed oral anticoagulation therapy versus oral anticoagulation patients on routine care. Randomised controlled trials (RCTs) were identified using the COCHRANE LIBRARY, MEDLINE and EMBASE from 1966 to 2003. RCTs were selected involving patients with oral anticoagulation, which were designed to compare a self-management group to a routine care group. Abstracts and keywords were screened and, in the case of potential inclusion, evaluated. We identified nine potentially relevant trials. Five were excluded for the following reasons: double publication, the patients involved performed only selftesting, or the results of the trial were only published as an abstract. Ultimately, four randomised controlled studies fulfilled the criteria for inclusion. Anticoagulation control: Statistical analysis was not possible because of the great variety of international normalised ratio measurements per patient between the different studies. Comparing the four studies, there was no difference in oral anticoagulation control between self-management care and management by a specialised anticoagulation clinic. In comparison with routine care by general practitioners, self-management care was found to be better. Major bleeding, arterial and venous thromboembolism: Data were available for all studies; however, the studies were either underpowered or obviously not valid and therefore not suitable for statistical analysis. Treatment-related quality of life: Data were available for two studies, which showed that self-management could clearly improve treatment-related quality of life. Patients’ self-management can improve the quality of oral anticoagulation as an indirect parameter of a reduced risk for thromboembolic and bleeding complications. Self-management oral anticoagulation treatment is safe and improves treatment-related quality of life. Patients’ self-management is safe and can improve the quality of anticoagulation control, however, no valid long term study has yet actually demonstrated reduction of bleeding and thromboembolic events.

Keywords

Oral anticoagulation - self-management - routine care - specialised anticoagulation clinic - general practitioner

Full Text

References

References
1 Hirsh J. Oral anticoagulant drugs. N Engl J Med 1991; 324: 1865-75.
2 Hirsh J, Dalen JE, Anderson DR. et al. Oral anticoagulants: mechanism of action, clinical effectiveness, and optimal therapeutic range. Chest 1998; 114 (Suppl. 05) 445-69.
3 Fairweather RB, Ansell J, van den Besselaar AM. et al. College of American Pathologists Conference XXXI on laboratory monitoring of anticoagulant therapy: laboratory monitoring of oral anticoagulant therapy. Arch Pathol Lab Med 1998; 122: 768-81.
4 Hylek EM, Skates SJ, Sheehan MA. et al. An analysis of the lowest effective intensity of prophylactic anticoagulation for patients with nonrheumatic atrial fibrillation. N Engl J Med 1996; 335: 540-6.
5 Hylek EM, Singer DE. Risk factors for intracranial hemorrhage in outpatients taking warfarin. Ann Intern Med 1994; 120: 897-902.
6 Cannegieter SC, Rosendaal FR, Wintzen AR. et al. Optimal oral anticoagulant therapy in patients with mechanical heart valves. N Engl J Med 1995; 333: 11-7.
7 Odèn A, Fahlèn M. Oral anticoagulation and risk of death: a medical record linkage study. Br Med J 2002; 325: 1073-75.
8 Erdman S, Vidne B, Levy MJ. A self control method for long term anticoagulation therapy. Cardiovasc Surg 1974; 15: 454-57.
9 White RH, McCurdy SA, von Marensdorff H. et al. Home prothrombin time monitoring after the initiation of warfarin therapy. A randomized prospective study. Ann Int Med 1989; 111a: 730-37.
10 Ansell JE, Holden A, Knapie N. Patients’ selfmanagement of oral anticoagulation guided by capillary (finger stick) whole blood prothrombin times. Arch Intern Med 1989; 149: 2509-11.
11 Ansell JE, Patel N, Ostrovsky D. et al. Longterm patient self-management of oral anticoagulation. Arch Intern Med 1995; 155: 2185-89.
12 Watzke HH, Forberg E, Svolba G. et al. A prospective controlled trial comparing weekly self-testing and self-dosing with the standard management of patients on stable oral anticoagulation. Thromb Haemost 2000; 83: 661-5.
13 Sawicki PT. for the working group for the study of patient self-management of oral anticoagulation. A structured teaching and self-management program for patients receiving oral anticoagulation. JAMA 1999; 281: 145-50.
14 Koertke H, Minami K, Bairaktaris A. et al. INR Self-Management following mechanical heart valve replacement. J Thromb Thrombolysis 2000; 09 (Suppl. 01) 39-43.
15 Koertke H, Korfer R. International normalized ratio self-management after mechanical heart valve replacement: is an early start advantageous?. Ann Thorac Surg 2001; 71 (01) 44-8.
16 Körtke H, Minami K, Breymann T. et al. INRSelbstmanagement nach mechanischem Herzklappenersatz: ESCAT (Early Self-Controlled Anticoagulation Trial). Z Kardiol 2001; 90 (Suppl. 06) VI/118-VI/124
17 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: 97-102.
18 Landefeld CS, Anderson PA, Goodnough LT. et al. The bleeding severity index: validation and comparison to other methods for classifying bleeding complications of medical therapy. J Clin Epidemiol 1989; 42: 711-18.
19 Todd C, Bradley C. Evaluation the design and development of psychological scales. In: Bradley C. Handbook of psychology and diabetes: a guide to psychological measurement in diabetes research and practice. Newark, NJ: Harwood Academic Publishers; 1994: 15-42.
20 Clarke M, Oxman AD. Cochrane Reviewers’ Handbook 4.0. 1999. In: Review Manager (RevMan). Version 4.0. Oxford, England: The Cochrane Collaboration.;
21 Jadad AR, Moore RA, Carroll D. et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary?. Control Clin Trials 1996; 17 (01) 1-12.
22 Schulz KF, Chalmers I, Hayes RJ. et al. Empirical evidence of bias: dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 1995; 273 (05) 408-12.
23 Beyth RB, Quinn L, Landefeld CS. A multicomponent intervention to prevent major bleeding complications in older patients receiving warfarin. A randomized controlled trial. Ann Intern Med 2000; 133: 687-95.
24 Horstkotte D, Piper C, Wiemer M. et al. Improvement of prognosis by home prothrombin estimation in patients with life-long anticoagulant therapy (abstract). Eur Heart J 1996; 17 (suppl): 230.
25 Bernardo A. Experience with patient self-management of oral anticoagulation. J Thromb Thrombolysis 1996; 02: 321-25.
26 Kulinna W, Ney D, Wenzel T. et al. The effect of self monitoring of the INR on quality of anticoagulation and the quality of life. Semin Thromb Hemost 1999; 25 (01) 123-6.
27 Sawicki PT, Glaeser B, Kleespies C. et al. Self-Management of oral anticoagulation: long-term results. J Int Med 2003; 254 (05) 515-6.
28 Rosendaal FR, Cannegieter SC, van der Meer FJ. et al. A method to determine optimal intensity of oral anticoagulation therapy. Thromb Haemost 1993; 69: 236-9.
29 Steffensen FH, Kristensen K, Ejlersen E. et al. Major haemorrhagic complications during oral anticoagulant therapy in a Danish population-based cohort. J Intern Med 1997; 242: 497-503.
30 Massicotte P, Marzinotto V, Veigh P. et al. Home monitoring of warfarin therapy in children with a whole blood prothrombin time monitor. J Pediatr 1995; 127: 389-94.
31 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: 347-52.
32 Christensen TD, Attermann J, Hjortdal VE. et al. Self-management of oral anticoagulation in children with congenital heart disease. Cardiol Young 2001; 11: 269-76.
33 Atrial Fibrillation Investigators. Risk factors for stroke and efficacy of antithrombotic therapy in atrial fibrillation. Analysis of pooled data from five randomized controlled trials. Arch Intern Med 1994; 154 (13) 1449-57.
34 Palareti G. on behalf of the Italian Study on complicatoins of oral anticoagulant therapy. Bleeding complications of oral anticoagulant treatment: an inception-cohort, prospective collaborative study (ISCOAT). Lancet 1996; 348: 423-28.
35 Ansell J, Hirsh J, Dalen J. et al. Managing Oral Anticoagulant Therapy. Chest 2001; 119 (Suppl. 01) 22S-38S.
36 Fitzmaurice DA, Machin SJ. on behalf of the British Society of Haematology Task Force for Haemostasis and Thrombosis. Recommendations for patients undertaking self-management of oral anticoagulation. Br Med J 2001; 323: 985-89.