Self-management of oral anticoagulation in the elderly: Rationale, design, baselines and oral anticoagulation control after one year of follow-up. A randomized controlled trial

Thrombosis and Haemostasis

Volumn 97, Issue 3, 2007, Pages 408-416

  Siebenhofer, Andrea ^a   Rakovac, Ivo ^b   Kleespies, Caroline ^c   Piso, Brigitte ^d   Didjurgeit, Ulrike ^c  

^a MEDICAL UNIVERSITY OF GRAZ   (Austria)

^b JOANNEUM RESEARCH   (Austria)

^c DleM Inst for Evidence Based Med   (Germany)

^d MEDICAL UNIVERSITY OF VIENNA   (Austria)

Author keywords

Elderly patients; Oral anticoagulation; Randomized controlled trial; Self management

Indexed keywords

ACENOCOUMAROL; ANTICOAGULANT AGENT; PHENPROCOUMON;

ADULT; AGED; ANTICOAGULANT THERAPY; ARTICLE; BLEEDING; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE CONTROL; DRUG EFFICACY; DRUG INDICATION; DRUG SAFETY; ELDERLY CARE; FEASIBILITY STUDY; FEMALE; FOLLOW UP; HEART ATRIUM FIBRILLATION; HEART VALVE PROSTHESIS; HUMAN; INTERNATIONAL NORMALIZED RATIO; LONG TERM CARE; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MALE; MORTALITY; MULTICENTER STUDY; PRIORITY JOURNAL; QUALITY CONTROL; RANDOMIZED CONTROLLED TRIAL; SELF CARE; STATISTICAL SIGNIFICANCE; THROMBOEMBOLISM; TREATMENT OUTCOME;

ADMINISTRATION, ORAL; AGED; ANTICOAGULANTS; AUSTRIA; BLOOD COAGULATION; DRUG MONITORING; FEASIBILITY STUDIES; FEMALE; FOLLOW-UP STUDIES; GERMANY; HEALTH KNOWLEDGE, ATTITUDES, PRACTICE; HEMORRHAGE; HUMANS; INTERNATIONAL NORMALIZED RATIO; MALE; MIDDLE AGED; PATIENT EDUCATION; PROGRAM EVALUATION; RESEARCH DESIGN; SELF CARE; THROMBOEMBOLISM; TIME FACTORS;

EID: 33947310924     PISSN: 03406245     EISSN: None     Source Type: Journal    
DOI: 10.1160/TH06-08-0482     Document Type: Article

References (36)

1. Ansell J, Hirsh J, Poller L, et al. The pharmacology and management of the vitamin K antagonists: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004; 126: 204S-233S.
2. Hirsh J. Oral anticoagulant drugs. N Engl J Med 1991; 324: 1865-1875.
3. Aguilar MI, Hart R. Oral anticoagulants for preventing stroke in patients with non-valvular atrial fibrillation and no previous history of stroke or transient ischemic attacks. Cochrane Database Syst Rev 2005; CD001927.
4. 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: 1449-1457.
5. Furberg CD, Psaty BM, Manolio TA, et al. Prevalence of atrial fibrillation in elderly subjects (the Cardiovascular Health Study). Am J Cardiol 1994; 74: 236-241.
6. Hylek EM, Go AS, Chang Y, et al. Effect of intensity of oral anticoagulation on stroke severity and mortality in atrial fibrillation. N Engl J Med 2003; 349: 1019-1026.
7. Bungard TJ, Ghali WA, Teo KK, et al. Why do patients with atrial fibrillation not receive warfarin? Arch Intern Med 2000; 160: 41-46.
8. Cohen N, Moznino-Sarafian D, Alon I, et al. Warfarin for stroke prevention still underused in atrial fibrillation: patterns of omission. Stroke 2000; 31: 1217-1222.
9. Gage BF, Boechler M, Doggette AL, et al. Adverse outcomes and predictors of underuse of antithrombotic therapy in medicare beneficiaries with chronic atrial fibrillation. Stroke 2000; 31: 822-827.
10. Hylek EM, D'Antonio J, Evans-Molina C, et al. Translating the results of randomized trials into clinical practice: the challenge of warfarin candidacy among hospitalized elderly patients with atrial fibrillation. Stroke 2006; 37: 1075-1080.
11. Palareti G, Leali N, Coccheri S, et al. Bleeding complications of oral anticoagulant treatment: an inception-cohort, prospective collaborative study (ISCOAT). Italian Study on Complications of Oral Anticoagulant Therapy. Lancet 1996; 348: 423-428.
12. Torn M, Bollen WL, van der Meer FJ, et al. Risks of oral anticoagulant therapy with increasing age. Arch Intern Med 2005; 165: 1527-1532.
13. 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: 540-546.
14. Cannegieter SC, Rosendaal FR, Wintzen AR, et al. Optimal oral anticoagulant therapy in patients with mechanical heart valves. N Engl J Med 1995; 333: 11-17.
15. Hylek EM, Singer DE. Risk factors for intracranial hemorrhage in outpatients taking warfarin. Ann Intern Med 1994; 120: 897-902.
16. Sawicki PT. A structured teaching and self-management program for patients receiving oral anticoagulation: a randomized controlled trial. Working Group for the Study of Patient Self-Management of Oral Anticoagulation. J Am Med Assoc 1999; 281: 145-150.
17. Siebenhofer A, Berghold A, Sawicki PT. Systematic review of studies of self-management of oral anticoagulation. Thromb Haemost 2004; 91: 225-232.
18. Heneghan C, Onso-Coello P, Garcia-Alamino JM, et al. Self-monitoring of oral anticoagulation: a systematic review and meta-analysis. Lancet 2006; 367: 404-411.
19. Beyth RJ, 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: 687-695.
20. van den Besselar AM. A comparison of INRs determined with a whole blood prothrombin time device and two international reference preparations for thromboplastin. Thromb Haemost 2000; 84: 410-412.
21. Landefeld CS, Beyth RJ. Anticoagulant-related bleeding: clinical epidemiology, prediction, and prevention. Am J Med 1993; 95: 315-328.
22. 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: 711-718.
23. Rosendaal FR, Cannegieter SC, van der Meer FJ, et al. A method to determine the optimal intensity of oral anticoagulant therapy. Thromb Haemost 1993; 69: 236-239.
24. Horsti J, Uppa H, Vilpo JA. Poor agreement among prothrombin time international normalized ratio methods: comparison of seven commercial reagents. Clin Chem 2005; 51: 553-560.
25. Sawicki PT, Glaser B, Kleespies C, et al. Self-management of oral anticoagulation: long-term results. J Intern Med 2003; 254: 515-516.
26. R Development Core Team. R: A language and environment for statistical computing. Available at: http://www.r-project.org. Accessed December 12, 2006.
27. Menendez-Jandula B, Souto JC, Oliver A, et al. Comparing self-management of oral anticoagulant therapy with clinic management: a randomized trial. Ann Intern Med 2005; 142: 1-10.
28. Khan TI, Kamali F, Kesteven P, et al. 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: 557-564.
29. Fitzmaurice DA, Murray ET, McCahon D, et al. Self management of oral anticoagulation: randomised trial. Br Med J 2005; 331: 1057.
30. Gadisseur AP, Breukink-Engbers WG, van der Meer FJ, et al. Comparison of the quality of oral anticoagulant therapy through patient self-management and management by specialized anticoagulation clinics in the Netherlands: a randomized clinical trial. Arch Intern Med 2003; 163: 2639-2646.
31. 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: 661-665.
32. Samsa GP, Matchar DB. 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 2000; 9: 283-292.
33. Cromheecke ME, Levi M, Colly LP, et al. Oral anticoagulation self-management and management by a specialist anticoagulation clinic: a randomised crossover comparison. Lancet 2000; 356: 97-102.
34. Gadisseur AP, Kaptein AA, Breukink-Engbers WG, et al. Patient self-management of oral anticoagulant care vs. management by specialized anticoagulation clinics: positive effects on quality of life. J Thromb Haemost 2004; 2: 584-591.
35. Regier DA, Sunderji R, Lynd LD, et al. Cost-effectiveness of self-managed versus physician-managed oral anticoagulation therapy. CMAJ 2006; 174: 1847-1852.
36. Taborski U, Wittstamm FJ, Bernardo A. Cost-effectiveness of self-managed anticoagulant therapy in Germany. Semin Thromb Hemost 1999; 25: 103-107.