Clinical trial NCT04357288 - References

Atrial Fibrillation — Randomized Evaluation of Decision Support Interventions for Atrial Fibrillation

Citation(s)

•   Agency for Healthcare Research and Quality
  CAHPS Clinician & Group Survey. 2018.
•   Benjamin EJ, Wolf PA, D'Agostino RB, Silbershatz H, Kannel WB, Levy D
  Impact of atrial fibrillation on the risk of death: the Framingham Heart Study. Circulation. 1998 Sep 8;98(10):946-52. doi: 10.1161/01.cir.98.10.946.
•   Bennett C, Graham ID, Kristjansson E, Kearing SA, Clay KF, O'Connor AM
  Validation of a preparation for decision making scale. Patient Educ Couns. 2010 Jan;78(1):130-3. doi: 10.1016/j.pec.2009.05.012. Epub 2009 Jun 26.
•   Boehringer-Ingelheim
  Dabigatran prescribing information. http://docs.boehringer-ingelheim.com/Prescribing Information/PIs/Pradaxa/Pradaxa.pdf. Published 2017. Accessed January 8, 2018.
•   Brehaut JC, O'Connor AM, Wood TJ, Hack TF, Siminoff L, Gordon E, Feldman-Stewart D
  Validation of a decision regret scale. Med Decis Making. 2003 Jul-Aug;23(4):281-92. doi: 10.1177/0272989X03256005.
•   Bristol-Myers Squibb Company
  Apixaban prescribing information. https://packageinserts.bms.com/pi/pi_eliquis.pdf. Published 2016. Accessed January 8, 2017.
•   Budnitz DS, Lovegrove MC, Shehab N, Richards CL
  Emergency hospitalizations for adverse drug events in older Americans. N Engl J Med. 2011 Nov 24;365(21):2002-12. doi: 10.1056/NEJMsa1103053.
•   Byrne PJ, Murphy A
  Informed consent and hypoplastic left heart syndrome. Acta Paediatr. 2005 Sep;94(9):1171-5. doi: 10.1111/j.1651-2227.2005.tb02069.x.
•   Camm AJ, Lip GY, De Caterina R, Savelieva I, Atar D, Hohnloser SH, Hindricks G, Kirchhof P; ESC Committee for Practice Guidelines (CPG)
  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. Eur Heart J. 2012 Nov;33(21):2719-47. doi: 10.1093/eurheartj/ehs253. Epub 2012 Aug 24. No abstract available. Erratum In: Eur Heart J. 2013 Mar;34(10):790. Eur Heart J. 2013 Sep;34(36):2850-1.
•   Conen D, Chae CU, Glynn RJ, Tedrow UB, Everett BM, Buring JE, Albert CM
  Risk of death and cardiovascular events in initially healthy women with new-onset atrial fibrillation. JAMA. 2011 May 25;305(20):2080-7. doi: 10.1001/jama.2011.659.
•   Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, Pogue J, Reilly PA, Themeles E, Varrone J, Wang S, Alings M, Xavier D, Zhu J, Diaz R, Lewis BS, Darius H, Diener HC, Joyner CD, Wallentin L; RE-LY Steering Committee and Investigators
  Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009 Sep 17;361(12):1139-51. doi: 10.1056/NEJMoa0905561. Epub 2009 Aug 30. Erratum In: N Engl J Med. 2010 Nov 4;363(19):1877.
•   Daichii Sankyo Inc
  Edoxaban prescribing information. http://dsi.com/prescribing-information-portlet/getPIContent?productName=Savaysa&inline=true. Published 2017. Accessed January 8, 2018.
•   Degner LF, Sloan JA, Venkatesh P
  The Control Preferences Scale. Can J Nurs Res. 1997 Fall;29(3):21-43.
•   Degner LF, Sloan JA
  Decision making during serious illness: what role do patients really want to play? J Clin Epidemiol. 1992 Sep;45(9):941-50. doi: 10.1016/0895-4356(92)90110-9.
•   Dorian P, Kongnakorn T, Phatak H, Rublee DA, Kuznik A, Lanitis T, Liu LZ, Iloeje U, Hernandez L, Lip GY
  Cost-effectiveness of apixaban vs. current standard of care for stroke prevention in patients with atrial fibrillation. Eur Heart J. 2014 Jul 21;35(28):1897-906. doi: 10.1093/eurheartj/ehu006. Epub 2014 Feb 9.
•   Elwyn G, Hutchings H, Edwards A, Rapport F, Wensing M, Cheung WY, Grol R
  The OPTION scale: measuring the extent that clinicians involve patients in decision-making tasks. Health Expect. 2005 Mar;8(1):34-42. doi: 10.1111/j.1369-7625.2004.00311.x.
•   Feigin VL, Forouzanfar MH, Krishnamurthi R, Mensah GA, Connor M, Bennett DA, Moran AE, Sacco RL, Anderson L, Truelsen T, O'Donnell M, Venketasubramanian N, Barker-Collo S, Lawes CM, Wang W, Shinohara Y, Witt E, Ezzati M, Naghavi M, Murray C; Global Burden of Diseases, Injuries, and Risk Factors Study 2010 (GBD 2010) and the GBD Stroke Experts Group
  Global and regional burden of stroke during 1990-2010: findings from the Global Burden of Disease Study 2010. Lancet. 2014 Jan 18;383(9913):245-54. doi: 10.1016/s0140-6736(13)61953-4. Erratum In: Lancet. 2014 Jan 18;383(9913):218.
•   Freeman JV, Zhu RP, Owens DK, Garber AM, Hutton DW, Go AS, Wang PJ, Turakhia MP
  Cost-effectiveness of dabigatran compared with warfarin for stroke prevention in atrial fibrillation. Ann Intern Med. 2011 Jan 4;154(1):1-11. doi: 10.7326/0003-4819-154-1-201101040-00289. Epub 2010 Nov 1.
•   Gallagher AM, Rietbrock S, Plumb J, van Staa TP
  Initiation and persistence of warfarin or aspirin in patients with chronic atrial fibrillation in general practice: do the appropriate patients receive stroke prophylaxis? J Thromb Haemost. 2008 Sep;6(9):1500-6. doi: 10.1111/j.1538-7836.2008.03059.x. Epub 2008 Jun 28.
•   Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz MD, Weitz JI, Spinar J, Ruzyllo W, Ruda M, Koretsune Y, Betcher J, Shi M, Grip LT, Patel SP, Patel I, Hanyok JJ, Mercuri M, Antman EM; ENGAGE AF-TIMI 48 Investigators
  Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013 Nov 28;369(22):2093-104. doi: 10.1056/NEJMoa1310907. Epub 2013 Nov 19.
•   Go AS, Hylek EM, Chang Y, Phillips KA, Henault LE, Capra AM, Jensvold NG, Selby JV, Singer DE
  Anticoagulation therapy for stroke prevention in atrial fibrillation: how well do randomized trials translate into clinical practice? JAMA. 2003 Nov 26;290(20):2685-92. doi: 10.1001/jama.290.20.2685.
•   Go AS, Hylek EM, Phillips KA, Chang Y, Henault LE, Selby JV, Singer DE
  Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA. 2001 May 9;285(18):2370-5. doi: 10.1001/jama.285.18.2370.
•   Graham DJ, Reichman ME, Wernecke M, Zhang R, Southworth MR, Levenson M, Sheu TC, Mott K, Goulding MR, Houstoun M, MaCurdy TE, Worrall C, Kelman JA
  Cardiovascular, bleeding, and mortality risks in elderly Medicare patients treated with dabigatran or warfarin for nonvalvular atrial fibrillation. Circulation. 2015 Jan 13;131(2):157-64. doi: 10.1161/CIRCULATIONAHA.114.012061. Epub 2014 Oct 30.
•   Granger CB, Alexander JH, McMurray JJ, Lopes RD, Hylek EM, Hanna M, Al-Khalidi HR, Ansell J, Atar D, Avezum A, Bahit MC, Diaz R, Easton JD, Ezekowitz JA, Flaker G, Garcia D, Geraldes M, Gersh BJ, Golitsyn S, Goto S, Hermosillo AG, Hohnloser SH, Horowitz J, Mohan P, Jansky P, Lewis BS, Lopez-Sendon JL, Pais P, Parkhomenko A, Verheugt FW, Zhu J, Wallentin L; ARISTOTLE Committees and Investigators
  Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011 Sep 15;365(11):981-92. doi: 10.1056/NEJMoa1107039. Epub 2011 Aug 27.
•   Harrington AR, Armstrong EP, Nolan PE Jr, Malone DC
  Cost-effectiveness of apixaban, dabigatran, rivaroxaban, and warfarin for stroke prevention in atrial fibrillation. Stroke. 2013 Jun;44(6):1676-81. doi: 10.1161/STROKEAHA.111.000402. Epub 2013 Apr 2.
•   Hart RG, Benavente O, McBride R, Pearce LA
  Antithrombotic therapy to prevent stroke in patients with atrial fibrillation: a meta-analysis. Ann Intern Med. 1999 Oct 5;131(7):492-501. doi: 10.7326/0003-4819-131-7-199910050-00003.
•   Hart RG, Pearce LA, Aguilar MI
  Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med. 2007 Jun 19;146(12):857-67. doi: 10.7326/0003-4819-146-12-200706190-00007.
•   Haynes RB, McKibbon KA, Kanani R
  Systematic review of randomised trials of interventions to assist patients to follow prescriptions for medications. Lancet. 1996 Aug 10;348(9024):383-6. doi: 10.1016/s0140-6736(96)01073-2. Erratum In: Lancet 1997 Apr 19;349(9059):1180.
•   Haynes RB, Taylor DW, Sackett DL, Gibson ES, Bernholz CD, Mukherjee J
  Can simple clinical measurements detect patient noncompliance? Hypertension. 1980 Nov-Dec;2(6):757-64. doi: 10.1161/01.hyp.2.6.757.
•   Hylek EM, Evans-Molina C, Shea C, Henault LE, Regan S
  Major hemorrhage and tolerability of warfarin in the first year of therapy among elderly patients with atrial fibrillation. Circulation. 2007 May 29;115(21):2689-96. doi: 10.1161/CIRCULATIONAHA.106.653048. Epub 2007 May 21.
•   Janssen Pharmaceuticals Inc
  Rivaroxaban prescribing information. https://www.xareltohcp.com/shared/product/xarelto/prescribing-information.pdf. Published 2011. Accessed January 8, 2018.
•   January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, Conti JB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT, Sacco RL, Stevenson WG, Tchou PJ, Tracy CM, Yancy CW; ACC/AHA Task Force Members
  2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the Heart Rhythm Society. Circulation. 2014 Dec 2;130(23):e199-267. doi: 10.1161/CIR.0000000000000041. Epub 2014 Mar 28. No abstract available. Erratum In: Circulation. 2014 Dec 2;130(23):e272-4.
•   Jowett S, Bryan S, Mant J, Fletcher K, Roalfe A, Fitzmaurice D, Lip GY, Hobbs FD
  Cost effectiveness of warfarin versus aspirin in patients older than 75 years with atrial fibrillation. Stroke. 2011 Jun;42(6):1717-21. doi: 10.1161/STROKEAHA.110.600767. Epub 2011 Apr 21.
•   Kaatz S, Ahmad D, Spyropoulos AC, Schulman S; Subcommittee on Control of Anticoagulation
  Definition of clinically relevant non-major bleeding in studies of anticoagulants in atrial fibrillation and venous thromboembolic disease in non-surgical patients: communication from the SSC of the ISTH. J Thromb Haemost. 2015 Nov;13(11):2119-26. doi: 10.1111/jth.13140. No abstract available.
•   Kamel H, Johnston SC, Easton JD, Kim AS
  Cost-effectiveness of dabigatran compared with warfarin for stroke prevention in patients with atrial fibrillation and prior stroke or transient ischemic attack. Stroke. 2012 Mar;43(3):881-3. doi: 10.1161/STROKEAHA.111.641027. Epub 2012 Feb 3.
•   Kim MH, Johnston SS, Chu BC, Dalal MR, Schulman KL
  Estimation of total incremental health care costs in patients with atrial fibrillation in the United States. Circ Cardiovasc Qual Outcomes. 2011 May;4(3):313-20. doi: 10.1161/CIRCOUTCOMES.110.958165. Epub 2011 May 3.
•   Kon AA, Ackerson L, Lo B
  How pediatricians counsel parents when no "best-choice" management exists: lessons to be learned from hypoplastic left heart syndrome. Arch Pediatr Adolesc Med. 2004 May;158(5):436-41. doi: 10.1001/archpedi.158.5.436.
•   Kriston L, Scholl I, Holzel L, Simon D, Loh A, Harter M
  The 9-item Shared Decision Making Questionnaire (SDM-Q-9). Development and psychometric properties in a primary care sample. Patient Educ Couns. 2010 Jul;80(1):94-9. doi: 10.1016/j.pec.2009.09.034. Epub 2009 Oct 30.
•   Krug S
  Rocket Surgery Made Easy: The Do-It Yourself Guide to Finding and Fixing Usability Problems. Berkley, CA: New Riders; 2010.
•   Lee S, Anglade MW, Pham D, Pisacane R, Kluger J, Coleman CI
  Cost-effectiveness of rivaroxaban compared to warfarin for stroke prevention in atrial fibrillation. Am J Cardiol. 2012 Sep 15;110(6):845-51. doi: 10.1016/j.amjcard.2012.05.011. Epub 2012 May 30.
•   Limone BL, Baker WL, Kluger J, Coleman CI
  Novel anticoagulants for stroke prevention in atrial fibrillation: a systematic review of cost-effectiveness models. PLoS One. 2013 Apr 23;8(4):e62183. doi: 10.1371/journal.pone.0062183. Print 2013.
•   Lin HJ, Wolf PA, Kelly-Hayes M, Beiser AS, Kase CS, Benjamin EJ, D'Agostino RB
  Stroke severity in atrial fibrillation. The Framingham Study. Stroke. 1996 Oct;27(10):1760-4. doi: 10.1161/01.str.27.10.1760.
•   Lloyd-Jones DM, Wang TJ, Leip EP, Larson MG, Levy D, Vasan RS, D'Agostino RB, Massaro JM, Beiser A, Wolf PA, Benjamin EJ
  Lifetime risk for development of atrial fibrillation: the Framingham Heart Study. Circulation. 2004 Aug 31;110(9):1042-6. doi: 10.1161/01.CIR.0000140263.20897.42. Epub 2004 Aug 16.
•   Mann DM, Ponieman D, Montori VM, Arciniega J, McGinn T
  The Statin Choice decision aid in primary care: a randomized trial. Patient Educ Couns. 2010 Jul;80(1):138-40. doi: 10.1016/j.pec.2009.10.008. Epub 2009 Dec 2.
•   McGrath ER, Kapral MK, Fang J, Eikelboom JW, Conghaile Ao, Canavan M, O'Donnell MJ; Investigators of the Ontario Stroke Registry
  Association of atrial fibrillation with mortality and disability after ischemic stroke. Neurology. 2013 Aug 27;81(9):825-32. doi: 10.1212/WNL.0b013e3182a2cc15. Epub 2013 Jul 31. Erratum In: Neurology. 2016 Feb 2;86(5):492. O'Conghaile, Aengus [Corrected to Conghaile, Aengus o].
•   Montori VM, Shah ND, Pencille LJ, Branda ME, Van Houten HK, Swiglo BA, Kesman RL, Tulledge-Scheitel SM, Jaeger TM, Johnson RE, Bartel GA, Melton LJ 3rd, Wermers RA
  Use of a decision aid to improve treatment decisions in osteoporosis: the osteoporosis choice randomized trial. Am J Med. 2011 Jun;124(6):549-56. doi: 10.1016/j.amjmed.2011.01.013.
•   Moyer A, Salovey P
  Patient participation in treatment decision making and the psychological consequences of breast cancer surgery. Womens Health. 1998 Summer;4(2):103-16.
•   Mullan RJ, Montori VM, Shah ND, Christianson TJ, Bryant SC, Guyatt GH, Perestelo-Perez LI, Stroebel RJ, Yawn BP, Yapuncich V, Breslin MA, Pencille L, Smith SA
  The diabetes mellitus medication choice decision aid: a randomized trial. Arch Intern Med. 2009 Sep 28;169(17):1560-8. doi: 10.1001/archinternmed.2009.293.
•   Naccarelli GV, Varker H, Lin J, Schulman KL
  Increasing prevalence of atrial fibrillation and flutter in the United States. Am J Cardiol. 2009 Dec 1;104(11):1534-9. doi: 10.1016/j.amjcard.2009.07.022.
•   O'Connor A, Cranney A
  User Manual - Acceptability [document on internet]. 1996.
•   O'Connor AM, Cranney A
  Sample Tool : Acceptability ( Osteoporosis Therapy ). https://decisionaid.ohri.ca/docs/develop/Tools/Acceptability_osteoporosis.pdf. Published 1996.
•   O'Connor AM
  Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105.
•   Ogilvie IM, Newton N, Welner SA, Cowell W, Lip GY
  Underuse of oral anticoagulants in atrial fibrillation: a systematic review. Am J Med. 2010 Jul;123(7):638-645.e4. doi: 10.1016/j.amjmed.2009.11.025.
•   Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, Breithardt G, Halperin JL, Hankey GJ, Piccini JP, Becker RC, Nessel CC, Paolini JF, Berkowitz SD, Fox KA, Califf RM; ROCKET AF Investigators
  Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011 Sep 8;365(10):883-91. doi: 10.1056/NEJMoa1009638. Epub 2011 Aug 10.
•   Ruff CT, Giugliano RP, Braunwald E, Hoffman EB, Deenadayalu N, Ezekowitz MD, Camm AJ, Weitz JI, Lewis BS, Parkhomenko A, Yamashita T, Antman EM
  Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet. 2014 Mar 15;383(9921):955-62. doi: 10.1016/S0140-6736(13)62343-0. Epub 2013 Dec 4.
•   Schulman S, Kearon C; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis
  Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005 Apr;3(4):692-4. doi: 10.1111/j.1538-7836.2005.01204.x.
•   Sevilla-Cazes J, Finkleman BS, Chen J, Brensinger CM, Epstein AE, Streiff MB, Kimmel SE
  Association Between Patient-Reported Medication Adherence and Anticoagulation Control. Am J Med. 2017 Sep;130(9):1092-1098.e2. doi: 10.1016/j.amjmed.2017.03.038. Epub 2017 Apr 26.
•   Shah SV, Gage BF
  Cost-effectiveness of dabigatran for stroke prophylaxis in atrial fibrillation. Circulation. 2011 Jun 7;123(22):2562-70. doi: 10.1161/CIRCULATIONAHA.110.985655. Epub 2011 May 23.
•   Siouta E, Hellstrom Muhli U, Hedberg B, Brostrom A, Fossum B, Karlgren K
  Patients' experiences of communication and involvement in decision-making about atrial fibrillation treatment in consultations with nurses and physicians. Scand J Caring Sci. 2016 Sep;30(3):535-46. doi: 10.1111/scs.12276. Epub 2015 Dec 28.
•   Stacey D, Legare F, Col NF, Bennett CL, Barry MJ, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Thomson R, Trevena L, Wu JH
  Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2014 Jan 28;(1):CD001431. doi: 10.1002/14651858.CD001431.pub4.
•   Steinberg BA, Gao H, Shrader P, Pieper K, Thomas L, Camm AJ, Ezekowitz MD, Fonarow GC, Gersh BJ, Goldhaber S, Haas S, Hacke W, Kowey PR, Ansell J, Mahaffey KW, Naccarelli G, Reiffel JA, Turpie A, Verheugt F, Piccini JP, Kakkar A, Peterson ED, Fox KAA; GARFIELD-AF; ORBIT-AF Investigators
  International trends in clinical characteristics and oral anticoagulation treatment for patients with atrial fibrillation: Results from the GARFIELD-AF, ORBIT-AF I, and ORBIT-AF II registries. Am Heart J. 2017 Dec;194:132-140. doi: 10.1016/j.ahj.2017.08.011. Epub 2017 Aug 24.
•   Street RL Jr, Voigt B
  Patient participation in deciding breast cancer treatment and subsequent quality of life. Med Decis Making. 1997 Jul-Sep;17(3):298-306. doi: 10.1177/0272989X9701700306.
•   Tu HT, Campbell BC, Christensen S, Collins M, De Silva DA, Butcher KS, Parsons MW, Desmond PM, Barber PA, Levi CR, Bladin CF, Donnan GA, Davis SM; Echoplanar Imaging Thrombolytic Evaluation Trial (EPITHET) Investigators
  Pathophysiological determinants of worse stroke outcome in atrial fibrillation. Cerebrovasc Dis. 2010;30(4):389-95. doi: 10.1159/000316886. Epub 2010 Aug 5.
•   Weymiller AJ, Montori VM, Jones LA, Gafni A, Guyatt GH, Bryant SC, Christianson TJ, Mullan RJ, Smith SA
  Helping patients with type 2 diabetes mellitus make treatment decisions: statin choice randomized trial. Arch Intern Med. 2007 May 28;167(10):1076-82. doi: 10.1001/archinte.167.10.1076.
•   Wolf PA, Abbott RD, Kannel WB
  Atrial fibrillation: a major contributor to stroke in the elderly. The Framingham Study. Arch Intern Med. 1987 Sep;147(9):1561-4.
•   Wolf PA, Dawber TR, Thomas HE Jr, Kannel WB
  Epidemiologic assessment of chronic atrial fibrillation and risk of stroke: the Framingham study. Neurology. 1978 Oct;28(10):973-7. doi: 10.1212/wnl.28.10.973.

Randomized Evaluation of Decision Support Interventions for Atrial Fibrillation

Details for clinical trial NCT04357288