Development of a Tool to Identify Patients' Preference for Vitamin K Antagonist or Direct Oral Anticoagulant Therapy

 

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Abstract

Direct oral anticoagulants (DOACs) were developed for the treatment of thromboembolic diseases to overcome limitations of vitamin K antagonists (VKA). International guidelines on atrial fibrillation acknowledge patients' for antiembolic therapy with VKA or DOAC as relevant decision criteria. The objective assessment of patients' preference social interactions and psychological factors are hard to measure albeit representing important contributors. After a series of structured interviews and pilot studies assessing the preparedness to use DOAC as an anticoagulant and the motivation of patients to participate in clinical studies with DOAC, seven items were identified from several questionnaires by regression analysis. Those items were seen the best to describe the willingness to change anticoagulation from VKA to DOAC. By their use, we aim to develop a tool for the objective identification of the patients' preferences for VKA or for DOAC to increase adherence to therapy and to reduce anticoagulant undertreatment. German-speaking patients were asked to fill out a questionnaire consisting of biographic data and the seven selected items, and 180 patients completed the questionnaire so far. Of these, 90 patients were on treatment with VKA (group 1), 57 patients changed anticoagulation from VKA to DOAC (group 2), 29 patients were DOAC naive patients (group 3), and 4 patients changed from DOAC to VKA (group 4). Overall, 94 patients received VKA, 29 patients received dabigatran, 50 patients received rivaroxaban, and 7 patients received apixaban as an anticoagulant. Eight patients were younger than 40 years, 35 patients were aged between 40 and 59 years, 53 patients were aged between 60 and 70 years, and 84 patients were aged older than 70 years. Indication for anticoagulation were atrial fibrillation (n = 106), pulmonary embolism (n = 24), deep vein thrombosis (n = 40), artificial heart valve replacement (n = 8), or other diseases (n = 2). Based on the results of the analysis, a score will be suggested to identify the preference of patients for anticoagulation with VKA or DOAC. This tool may be useful for practitioners and health-care professionals to support patient adherence to therapy, and thereby increase treatment effectiveness.

• References

• 1 Roskell NS, Lip GY, Noack H, Clemens A, Plumb JM. Treatments for stroke prevention in atrial fibrillation: a network meta-analysis and indirect comparisons versus dabigatran etexilate. Thromb Haemost 2010; 104 (6) 1106-1115
  Article in Thieme ConnectPubMedGoogle Scholar
• 2 Lip GY. Stroke in atrial fibrillation: epidemiology and thromboprophylaxis. J Thromb Haemost 2011; 9 (Suppl. 01) 344-351
  CrossrefPubMedGoogle Scholar
• 3 Falck-Ytter Y, Francis CW, Johanson NA , et al; American College of Chest Physicians. Prevention of VTE in orthopedic surgery patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141 (2, Suppl) e278S-e325S
  CrossrefPubMedGoogle Scholar
• 4 Moser M, Bode C. [Anticoagulation in atrial fibrillation: a new era has begun]. Hamostaseologie 2012; 32 (1) 37-39
  Article in Thieme ConnectPubMedGoogle Scholar
• 5 Schulman S, Beyth RJ, Kearon C, Levine MN ; American College of Chest Physicians. Hemorrhagic complications of anticoagulant and thrombolytic treatment: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 2008; 133 (6, Suppl) 257S-298S
  CrossrefPubMedGoogle Scholar
• 6 Lip GY, Andreotti F, Fauchier L , et al; European Heart Rhythm Association. Bleeding risk assessment and management in atrial fibrillation patients. Executive Summary of a Position Document from the European Heart Rhythm Association [EHRA], endorsed by the European Society of Cardiology [ESC] Working Group on Thrombosis. Thromb Haemost 2011; 106 (6) 997-1011
  Article in Thieme ConnectPubMedGoogle Scholar
• 7 Ansell J, Hirsh J, Hylek E, Jacobson A, Crowther M, Palareti G ; American College of Chest Physicians. Pharmacology and management of the vitamin K antagonists: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 2008; 133 (6, Suppl) 160S-198S
  CrossrefPubMedGoogle Scholar
• 8 Harenberg J, Marx S, Krejczy M, Wehling M. New anticoagulants - promising and failed developments. Br J Pharmacol 2012; 165 (2) 363-372
  CrossrefPubMedGoogle Scholar
• 9 Ogilvie IM, Newton N, Welner SA, Cowell W, Lip GY. Underuse of oral anticoagulants in atrial fibrillation: a systematic review. Am J Med 2010; 123 (7) 638-645 e4
  CrossrefPubMedGoogle Scholar
• 10 Bates SM, Greer IA, Middeldorp S, Veenstra DL, Prabulos AM, Vandvik PO ; American College of Chest Physicians. VTE, thrombophilia, antithrombotic therapy, and pregnancy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141 (2, Suppl) e691S-e736S
  CrossrefPubMedGoogle Scholar
• 11 Hirsh J, O'Donnell M, Eikelboom JW. Beyond unfractionated heparin and warfarin: current and future advances. Circulation 2007; 116 (5) 552-560
  CrossrefPubMedGoogle Scholar
• 12 Eikelboom JW, Weitz JI. A replacement for warfarin: the search continues. Circulation 2007; 116 (2) 131-133
  CrossrefPubMedGoogle Scholar
• 13 Devereaux PJ, Anderson DR, Gardner MJ , et al. Differences between perspectives of physicians and patients on anticoagulation in patients with atrial fibrillation: observational study. BMJ 2001; 323 (7323) 1218-1222
  CrossrefPubMedGoogle Scholar
• 14 Mühlbacher AC, Stoll M, Mahlich J, Nübling M. Patient preferences for HIV/AIDS therapy - a discrete choice experiment. Health Econ Rev 2013; 3 (1) 14
  CrossrefPubMedGoogle Scholar
• 15 Holbrook A, Schulman S, Witt DM , et al; American College of Chest Physicians. 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 (2, Suppl) e152S-e184S
  CrossrefPubMedGoogle Scholar
• 16 Anderson JL, Halperin JL, Albert NM , et al. Management of patients with atrial fibrillation (compilation of 2006 ACCF/AHA/ESC and 2011 ACCF/AHA/HRS recommendations): a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2013; 61 (18) 1935-1944
  CrossrefPubMedGoogle Scholar
• 17 Camm AJ, Lip GY, De Caterina R , et al; ESC Committee for Practice Guidelines-CPG; Document Reviewers. 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation—developed with the special contribution of the European Heart Rhythm Association. Europace 2012; 14 (10) 1385-1413
  CrossrefPubMedGoogle Scholar
• 18 MacLean S, Mulla S, Akl EA , et al; American College of Chest Physicians. Patient values and preferences in decision making for antithrombotic therapy: a systematic review: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141 (2, Suppl) e1S-e23S
  CrossrefPubMedGoogle Scholar
• 19 Moia M, Mantovani LG, Carpenedo M , et al. Patient preferences and willingness to pay for different options of anticoagulant therapy. Intern Emerg Med 2013; 8 (3) 237-243
  CrossrefPubMedGoogle Scholar
• 20 Harenberg J, Marx S, Abou-Ayash N , et al. Which patients would be willing to change anticoagulation from vitamin-K antagonists to a new oral anticoagulant?. Haemostaseologie 2012; 33 (1) ED10-4
  PubMedGoogle Scholar
• 21 Elewa HF, Deremer CE, Keller K, Gujral J, Joshua TV. Patients satisfaction with warfarin and willingness to switch to dabigatran: a patient survey. J Thromb Thrombolysis 2013;
  PubMedGoogle Scholar
• 22 Zolfaghari S, Harenberg J, Knäble H , et al. Investigation on motivation of patients to participate in clinical studies with new oral anticoagulants. Haemostaseologie 2013; 34 (1) P5-19
  PubMedGoogle Scholar
• 23 Crawford B, Stanford RH, Wong AY, Dalal AA, Bayliss MS. Development of a questionnaire to assess experience and preference of intranasal corticosteroids in patients with allergic rhinitis. Patient Relat Outcome Meas 2011; 2: 119-126
  PubMedGoogle Scholar
• 24 Klausmann G, Hramiak I, Qvist M, Mikkelsen KH, Guo X. Evaluation of preference for a novel durable insulin pen with memory function among patients with diabetes and health care professionals. Patient Prefer Adherence 2013; 7: 285-292
  PubMedGoogle Scholar
• 25 Nelsen A, Gupta S, Trautner BW , et al. Intention to adhere to HIV treatment: a patient-centred predictor of antiretroviral adherence. HIV Med 2013; 14 (8) 472-480
  CrossrefPubMedGoogle Scholar
• 26 Politi MC, Wolin KY, Légaré F. Implementing clinical practice guidelines about health promotion and disease prevention through shared decision making. J Gen Intern Med 2013; 28 (6) 838-844
  CrossrefPubMedGoogle Scholar
• 27 Sudlow M, Thomson R, Kenny RA, Rodgers H. A community survey of patients with atrial fibrillation: associated disabilities and treatment preferences. Br J Gen Pract 1998; 48 (436) 1775-1778
  PubMedGoogle Scholar
• 28 Thomson R, Parkin D, Eccles M, Sudlow M, Robinson A. Decision analysis and guidelines for anticoagulant therapy to prevent stroke in patients with atrial fibrillation. Lancet 2000; 355 (9208) 956-962
  CrossrefPubMedGoogle Scholar
• 29 Protheroe J, Fahey T, Montgomery AA, Peters TJ. The impact of patients' preferences on the treatment of atrial fibrillation: observational study of patient based decision analysis. BMJ 2000; 320 (7246) 1380-1384
  CrossrefPubMedGoogle Scholar
• 30 Man-Son-Hing M, Laupacis A, O'Connor AM, Coyle D, Berquist R, McAlister F. Patient preference-based treatment thresholds and recommendations: a comparison of decision-analytic modeling with the probability-tradeoff technique. Med Decis Making 2000; 20 (4) 394-403
  CrossrefPubMedGoogle Scholar
• 31 Schulman S, Crowther MA. How I treat with anticoagulants in 2012: new and old anticoagulants, and when and how to switch. Blood 2012; 119 (13) 3016-3023
  CrossrefPubMedGoogle Scholar
• 32 Harenberg J, Felten M, Weiss C, Frölich L. The stability of the INR, the fear of thrombotic and bleeding complications are influenced by personality traits of patients on stable oral anticoagulant therapy. Haemostaseologie 2010; 30 (1) P02-P10
  PubMedGoogle Scholar
• 33 Franke GH. Possibilities of computer-assisted administration of the revised Freiburg Personality Inventory. 2 experimental studies[in German]. Z Exp Psychol 1997; 44 (2) 332-356
  PubMedGoogle Scholar
• 34 Forgays DG, Forgays DK, Spielberger CD. Factor structure of the State-Trait Anger Expression Inventory. J Pers Assess 1997; 69 (3) 497-507
  CrossrefPubMedGoogle Scholar
• 35 Fisher PL, Durham RC. Recovery rates in generalized anxiety disorder following psychological therapy: an analysis of clinically significant change in the STAI-T across outcome studies since 1990. Psychol Med 1999; 29 (6) 1425-1434
  CrossrefPubMedGoogle Scholar
• 36 Sanderson K, Andrews G. The SF-12 in the Australian population: cross-validation of item selection. Aust N Z J Public Health 2002; 26 (4) 343-345
  CrossrefPubMedGoogle Scholar
• 37 Verkuil B, Brosschot JF, Thayer JF. Capturing worry in daily life: are trait questionnaires sufficient?. Behav Res Ther 2007; 45 (8) 1835-1844
  CrossrefPubMedGoogle Scholar
• 38 Ware Jr J, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care 1996; 34 (3) 220-233
  CrossrefPubMedGoogle Scholar
• 39 Svirtlih N, Pavic S, Terzic D , et al. Reduced quality of life in patients with chronic viral liver disease as assessed by SF12 questionnaire. J Gastrointestin Liver Dis 2008; 17 (4) 405-409
  PubMedGoogle Scholar
• 40 Völler H, Taborski U, Dovifat C , et al. ProTime self-management yielding improvement of fluency and quality of life. Thromb Haemost 2007; 98 (4) 889-895
  PubMedGoogle Scholar
• 41 Crawford B, Stanford RH, Wong AY, Dalal AA, Bayliss MS. Psychometric validation of the experience with allergic rhinitis nasal spray questionnaire. Patient Relat Outcome Meas 2011; 2: 127-133
  PubMedGoogle Scholar
• 42 Smetana GW, Davis RB, Phillips RS. Factors that influence patient response to requests to change to a unified restrictive formulary. J Gen Intern Med 2004; 19 (12) 1212-1219
  CrossrefPubMedGoogle Scholar
• 43 Mussbrugger H, Kelava A. Testtheorie und Fragebogenkonstruktion. Berlin, Heidelberg. New York, NY: Springer Verlag; 2008: 409
  CrossrefGoogle Scholar
• 44 Rogers MP, Orav J, Black PM. The use of a simple Likert scale to measure quality of life in brain tumor patients. J Neurooncol 2001; 55 (2) 121-131
  CrossrefPubMedGoogle Scholar
• 45 Makowski CT, Jennings DL, Nemerovski CW, Szandzik EG, Kalus JS. The impact of pharmacist-directed patient education and anticoagulant care coordination on patient satisfaction. Ann Pharmacother 2013; 47 (6) 805-810
  CrossrefPubMedGoogle Scholar
• 46 Casula M, Tragni E, Catapano AL. Adherence to lipid-lowering treatment: the patient perspective. Patient Prefer Adherence 2012; 6: 805-814
  PubMedGoogle Scholar
• 47 Alonso-Coello P, Montori VM, Solà I , et al. Values and preferences in oral anticoagulation in patients with atrial fibrillation, physicians' and patients' perspectives: protocol for a two-phase study. BMC Health Serv Res 2008; 8: 221
  CrossrefPubMedGoogle Scholar
• 48 González-Rojas N, Giménez E, Fernández MA , et al. Preferences for oral anticoagulant treatment in the medium and long term prevention of stroke in non valvular atrial fibrillation [in Spanish]. Rev Neurol 2012; 55 (1) 11-19
  PubMedGoogle Scholar
• 49 Tversky A, Kahneman D. The framing of decisions and the psychology of choice. Science 1981; 211 (4481) 453-458
  CrossrefPubMedGoogle Scholar
• 50 Bergus GR, Levin IP, Elstein AS. Presenting risks and benefits to patients. J Gen Intern Med 2002; 17 (8) 612-617
  CrossrefPubMedGoogle Scholar
• 51 Maxwell GL, Synan I, Hayes RP, Clarke-Pearson DL. Preference and compliance in postoperative thromboembolism prophylaxis among gynecologic oncology patients. Obstet Gynecol 2002; 100 (3) 451-455
  CrossrefPubMedGoogle Scholar
• 52 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; 282 (8) 737-743
  CrossrefPubMedGoogle Scholar
• 53 Draycott S, Dabbs A. Cognitive dissonance. 1: An overview of the literature and its integration into theory and practice in clinical psychology. Br J Clin Psychol 1998; 37 (Pt 3) 341-353
  CrossrefPubMedGoogle Scholar
• 54 Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine 2000; 25 (24) 3186-3191
  CrossrefPubMedGoogle Scholar