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Decision aid, atrial fibrillation, anticoagulation, warfarin, dabigatran, validation
Decision aids have been helpful to support patients in decision-making including anticoagulation. With the introduction of new oral anticoagulants (NOACs), it will be important to assist patients and physicians in shared decision-making about NOACs and warfarin.
To validate a patient decision aid (DA) for warfarin versus dabigatran, the first NOAC approved for atrial fibrillation (AF).
Participants without AF and not taking anticoagulants were recruited for the validation exercise. The decision aid described AF, stroke, and hemorrhagic events in terms of incidence, clinical presentation, and prognosis. Warfarin and dabigatran were then compared on multiple clinical and process outcomes as outlined in the pivotal clinical trial. Our primary outcome was confidence in making a treatment decision, using a decisional conflict scale. Secondary outcomes were change in knowledge scores and ratings of clarity, helpfulness and comprehensiveness.
35 patients (mean age 62.7 [SD 9.68], 37.1% female) participated. After use of the decision aid, the mean total decisional conflict score was low at 18.9 (SD: 14.2). Mean knowledge score improved significantly from 4.60 (SD 1.48) to 6.42 (SD 0.80) out of a total score of 7. Only one participant (2.9%) found the decision aid difficult to understand. All 35 participants rated the DA as helpful for making a decision about anticoagulant treatment for AF. Two participants (5.7%) requested more information on adverse effects of the two drugs.
Our DA to allow patients to make an informed decision with their physician regarding dabigatran versus warfarin in AF, proved understandable, comprehensive and helpful.
2. You JJ, Singer DE, Howard PA, et al. Antithrombotic therapy for atrial fibrillation: Antithrombotic therapy and prevention of thrombosis, 9th ed: American college of chest physicians evidence-based clinical practice guidelines. Chest 2012 Feb;141(2 Suppl): e531S-75S.
3. Hirsh J, Dalen J, Anderson DR, et al. Oral anticoagulants mechanism of action, clinical effectiveness, and optimal therapeutic range. Chest 2001 Jan;119(1 Suppl):8S-21S.
4. Campeau L. Top Rx Drugs of 2010. (2011) http://www.canadianhealthcarenetwork.ca/pharmacists/news/drug-news/top-rx-drugs-of-2010-9850 (May 24, 2011).
5. Singer DE, Albers GW, Dalen JE, et al. Antithrombotic therapy in atrial fibrillation: American college of chest physicians evidence-base clinical practice guidelines (8th Edition). Chest 2008 Jun;133(6 Suppl):546S-592S.
6. Holbrook A, Labiris R, Goldsmith CH, Ota K, Harb S, Sebaldt RJ. Influence of decision aids on patient preferences for anticoagulant therapy: a Randomized trial. CMAJ 2007 May 22;176(11):1583-1587.
7. Rieder MJ, Reiner AP, Gage BF, et al. Effect of VKORC1 haplotypes on transcriptional regulation and warfarin dose. N Engl J Med 2005 Jun 2;352(22):2285-2293.
8. Holbrook A, Schulman S, Witt DM, 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 Feb;141(2 Suppl):e152S-84S.
9. Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009 Sep 17;361(12):1139-1151.
10. Zeidan A, Faltas B, Streiff M. Dabigatran etexilate: what do hospitalists need to know? J Hosp Med 2012 Mar;7(3):262-269.
11. Lip GY, Nieuwlaat R, Pisters R, Lane DA, Crijns HJ. Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: the Euro heart survey on atrial fibrillation. Chest 2010 Feb;137(2):263-272.
12. Pisters R, Lane DA, Nieuwlaat R, de Vos CB, Crijns HJ, Lip GY. A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation: the Euro Heart Survey. Chest 2010 Nov;138(5):1093-1100.
13. Stacey D, Bennett CL, Barry MJ, et al. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev 2011 Oct 5;(10) (10):CD001431.
14. Holbrook AM, Nikitovic M, Troyan S, Pullyenagum E, Crowther M. Will individualized benefit-harm risk information affect patients' decisions regarding warfarin? Can J Clin Pharmacol 2010 March 26;17(1):e123.
15. Holbrook A, Labiris R, Goldsmith C, Ota K, Harb S, Sebaldt R. Influence of decision aids on patient preferences for anticoagulant therapy: a randomized trial. CMAJ 2007 May;176:1583-1587.
16. Ottawa Hospital Research Institute. Patient Decision Aid. http://decisionaid.ohri.ca/ index.html (Nov 22, 2012).
17. Elwyn G, O'Connor A, Stacey D, et al. Developing a quality criteria framework for patient decision aids: Online international Delphi consensus process. BMJ 2006 Aug 26;333(7565):417.
18. Bristol-Myers Squibb Canada. Coumadin [pdf on Internet]. (July 12, 2012). http://www. bmscanada.ca/static/products/en/pm_pdf/COUMADIN_EN_PM.pdf (Oct 28, 2012).
19. Boehringer Ingelheim Canada Ltd. Pradax [pdf Internet]. (January 27, 2012). http://www.boehringer-ingelheim.ca/ content/ dam/internet/opu/ca_EN/documents/humanhealth/product_monograph/Pradax-pm.pdf (Oct 28, 2012).
20. U.S. Food and Drug Administration. FDA drug safety communication: safety review of post-market reports of serious bleeding events with the anticoagulant Pradaxa (dabigatran etexilate mesylate) [Internet]. (July 12, 2012) http://www.fda.gov/Drugs/DrugSafety/ucm282724.htm (October 28, 2012).
21. Canadian Agency for Drugs and Technologies in Health. CEDAC final recommendation: Dabigatran etexilate [pdf on Internet]. (June 22, 2011) http://www.cadth.ca/media/cdr/ complete/cdr_complete_Pradax_June-27-11.pdf. (Oct 28, 2012).
22. Institute for Safe Medication Practices. Anticoagulants the leading reported drug risk in 2011 [pdf on Internet]. (May 31, 2012) http://www.ismp.org/quarterwatch/pdfs/2011Q4.pdf (Oct 28, 2012).
23. McLaughlin G. SMOG: Simple measure of gobbledygook(2008). http://www.harry mclaughlin. com/SMOG.htm (October 28, 2012)
24. Katzman R, Brown T, Fuld P, Peck A, Schechter R, Schimmel H. Validation of a short Orientation-Memory-Concentration Test of cognitive impairment. Am J Psychiatry 1983 Jun;140(6):734-739.
25. O'Connor AM. Validation of a decisional conflict scale. Med Decis Making 1995 Jan-Mar;15(1):25-30.
26. Fraenkel L, Street RL Jr, Fried TR. Development of a tool to improve the quality of decision making in atrial fibrillation. BMC Med Inform Decis Mak 2011 Oct 6;11:59.
27. Thomson RG, Eccles MP, Steen IN, et al. A patient decision aid to support shared decision-making on anti-thrombotic treatment of patients with atrial fibrillation: Randomised controlled trial. Qual Saf Health Care 2007 Jun;16(3):216-223.
28. Man-Son-Hing M, Laupacis A, O'Connor AM, et al. A patient decision aid regarding antithrombotic therapy for stroke prevention in atrial fibrillation: a randomized controlled trial. JAMA 1999 Aug 25;282(8):737-743.
29. LaHaye SA, Gibbens SL, Ball DG, Day AG, Olesen JB, Skanes AC. A clinical decision aid for the selection of antithrombotic therapy for the prevention of stroke due to atrial fibrillation. Eur Heart J 2012 Sep;33(17): 2163-2171.
30. Feinberg WM, Blackshear JL, Laupacis A, Kronmal R, Hart RG. Prevalence, age distribution, and gender of patients with atrial fibrillation. Analysis and implications. Arch Intern Med 1995 Mar 13;155(5):469-473.