Developing an Atrial Fibrillation Guideline Support Tool (AFGuST) for shared decision making

Abstract

Objective:

Patient values and preferences are an important component to decision making when tradeoffs exist that impact quality of life, such as tradeoffs between stroke prevention and hemorrhage in patients with atrial fibrillation (AF) contemplating anticoagulant therapy. Our objective is to describe the development of an Atrial Fibrillation Guideline Support Tool (AFGuST) to assist the process of integrating patients’ preferences into this decision.

Materials and methods:

CHA₂DS₂VASc and HAS-BLED were used to calculate risks for stroke and hemorrhage. We developed a Markov decision analytic model as a computational engine to integrate patient-specific risk for stroke and hemorrhage and individual patient values for relevant outcomes in decisions about anticoagulant therapy.

Results:

Individual patient preferences for health-related outcomes may have greater or lesser impact on the choice of optimal antithrombotic therapy, depending upon the balance of patient-specific risks for ischemic stroke and major bleeding. These factors have been incorporated into patient-tailored booklets which, along with an informational video, were developed through an iterative process with clinicians and patient focus groups.

Key limitations:

Current risk prediction models for hemorrhage, such as the HAS-BLED, used in the AFGuST, do not incorporate all potentially significant risk factors. Novel oral anticoagulant agents recently approved for use in the United States, Canada, and Europe have not been included in the AFGuST. Rather, warfarin has been used as a conservative proxy for all oral anticoagulant therapy.

Conclusions:

We present a proof of concept that a patient-tailored decision-support tool could bridge the gap between guidelines and practice by incorporating individual patient’s stroke and bleeding risks and their values for major bleeding events and stroke to facilitate a shared decision making process. If effective, the AFGuST could be used as an adjunct to published guidelines to enhance patient-centered conversations about the anticoagulation management.

Keywords: :

• Atrial fibrillation
• Decision analysis
• Decision support tools
• Shared decision making

Transparency

Declaration of funding

Support for this study came from the Informed Medical Decisions Foundation, Pfizer Educational Group, and NIH/NCATS Grant Number 8UL1TR000077-05. The funding sources had no role in the planning, design, or conduct of this study or the writing of this report. The findings and conclusions in this manuscript do not necessarily reflect the view of the Informed Medical Decisions Foundation.

Acknowledgements

Special thanks to Nita Walker, MD, Medical Director of the University of Cincinnati Health Primary Care Network for participation as a member of our project team, helping to facilitate interviews with clinicians in the Primary Care Network, and supporting our care improvement initiative for patients with atrial fibrillation.

Declaration of financial/other relationships

M.H.E. has disclosed that he has received research support from the Pfizer Medical Education Group. G.Y.H.L. has disclosed that he has served as a consultant for Bayer, Astellas, Merck, Sanofi, BMS/Pfizer, Daiichi-Sankyo, Biotronik, Medtronic, Portola and Boehringer Ingelheim and has been on the speakers bureau for Bayer, BMS/Pfizer, Boehringer Ingelheim, Daiichi-Sankyo, Medtronic and Sanofi Aventis. M.F. has disclosed that he has received research support from the Pfizer Medical Education Group, and has served as a consultant to Boehringer Ingelheim, and has served on an advisory board for, as a consultant to, and on a speaker’s program for CSL Behring. R.E.W. has disclosed that she has received research support from the Pfizer Medical Education Group. L.A. has disclosed that she has received research support from the Pfizer Medical Education Group. D.K. has disclosed that she has received research support from the Pfizer Medical Education Group. B.K. has disclosed that he has received research support from the Pfizer Medical Education Group. J.K. and A.C. have disclosed that they have received research support from the Pfizer Medical Education Group. K.N., F.K., and D.P.S have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article.

CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.