Development of a shared decision-making tool to assist patients and clinicians with decisions on oral anticoagulant treatment for atrial fibrillation

Abstract

Objective:

Decision aids (DAs) are increasingly used to operationalize shared decision-making (SDM) but their development is not often described. Decisions about oral anticoagulants (OACs) for atrial fibrillation (AF) involve a trade-off between lowering stroke risk and increasing OAC-associated bleeding risk, and consideration of how treatment affects lifestyle. The benefits and risks of OACs hinge upon a patient’s risk factors for stroke and bleeding and how they value these outcomes. We present the development of a DA about AF that estimates patients’ risks for stroke and bleeding and assesses their preferences for outcomes.

Research design and methods:

Based on a literature review and expert discussions, we identified stroke and major bleeding risk prediction models and embedded them into risk assessment modules. We identified the most important factors in choosing OAC treatment (warfarin used as the default reference OAC) through focus group discussions with AF patients who had used warfarin and clinician interviews. We then designed preference assessment and introductory modules accordingly. We integrated these modules into a prototype AF SDM tool and evaluated its usability through interviews.

Results:

Our tool included four modules: (1) introduction to AF and OAC treatment risks and benefits; (2) stroke risk assessment; (3) bleeding risk assessment; and (4) preference assessment. Interactive risk calculators estimated patient-specific stroke and bleeding risks; graphics were developed to communicate these risks. After cognitive interviews, the content was improved. The final AF tool calculates patient-specific risks and benefits of OAC treatment and couples these estimates with patient preferences to improve clinical decision-making.

Conclusions:

The AF SDM tool may help patients choose whether OAC treatment is best for them and represents a patient-centered, integrative approach to educate patients on the benefits and risks of OAC treatment. Future research is needed to evaluate this tool in a real-world setting. The development process presented can be applied to similar SDM tools.

Keywords: :

• Atrial fibrillation
• Decision aid
• Hemorrhage
• Oral anticoagulants
• Risk prediction models
• Shared decision making
• Stroke

Transparency

Declaration of funding

Janssen Scientific Affairs LLC sponsored the study.

Author contributions: K.K., W.Y.C., S.J., M.L.C., A.C., N.C., and J.S. conceptualized the project. W.Y.C., A.T., F.S., A.C., and J.S. performed the literature review and coordinated with a web development team to develop the online AF SDM tool. K.K., S.J., M.L.C., and J.J.G. conducted patient focus groups, clinician interviews, and cognitive interviews, data collection, and analyses. All authors contributed to the finalization of the AF SDM tool, and drafted the original submission of this manuscript. All authors read and approved the final manuscript.

Declaration of financial/other relationships

W.Y.C., A.T., F.S., and A.C. have disclosed that they are employees of Analysis Group Inc., a contract research organization that received research grants from Janssen Scientific Affairs LLC to conduct the research for this study, develop the new atrial fibrillation (AF) shared decision-making (SDM) tool, and to engage the remainder of the AF SDM research consortium. K.K., S.J., and J.J.G. have disclosed that they are Northwestern University employees whom Analysis Group Inc. contracted to participate in the research. M.L.C. has disclosed that she was an employee of Northwestern University at the time of the study. N.C. has disclosed that she is a member of the Steering Committee for the International Patient Decision Aid Standards collaboration, and was part of the SDM research consortium from Shared Decision Making Resources; she received compensation as a consultant to Janssen Scientific Affairs LLC for this study. J.S. has disclosed that he is a full-time employee of Janssen Scientific Affairs LLC.

CMRO peer reviewers on this manuscript have received an honorarium for their review work, but have relevant financial or other relationships to disclose.

Acknowledgments

We would like to thank Azra Muftic for her assistance with patient recruitment and data collection. Additionally, we would like to thank James Froehlich, Director of Michigan Cardiovascular Outcomes Research and Reporting Program, along with co-author Jeffrey Goldberger, Professor of Medicine-Cardiology at Northwestern University, for serving as key opinion leaders in this study.