Abstract
Purpose
To describe the process used to develop an evidence-based patient decision aid (PDA) that facilitates shared decision-making for treatment intensification in inadequately controlled type 2 diabetes mellitus (T2DM) consistent with International Patient Decision Aids Standards.
Methods
A PDA was developed by a multidisciplinary steering committee of clinicians, patient advocate, nurse, certified diabetes educators, and decision scientist, using a systematic development process. The process included defining the PDA scope and purpose, outlining the framework, content creation, and designing for integration into clinical practice. This was accomplished through a review of the literature and publically available educational materials and input from practicing clinicians and patients during development and iteratively refining content based on input. Patients with poorly controlled T2DM on metformin considering additional medication assessed the PDA during a pilot.
Results
Testing identified six preference-sensitive domains important for choosing T2DM treatment: degree of glycemic response, avoiding weight gain, hypoglycemia risk and other adverse events, avoiding injections, convenience of dose administration, blood glucose monitoring, and cost of therapy. Patient feedback guided content revision. Treatment options were offered after presenting medication class risk–benefit information and eliciting patient values, goals, and preferences. The PDA received the highest International Patient Decision Aids Standards global score to date, 88/100, with 100% of criteria fully met for the following dimensions: development process, disclosures, evaluation process, evidence quality, guidance for users, information quality, language/readability, testing, and eliciting patient values.
Conclusion
A PDA was developed to help T2DM patients make decisions regarding medication choice. This approach may be applicable to other chronic conditions.
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Acknowledgments
The authors thank the Development Steering Committee members: Nananda Col, MD, MPP, MPH, FACP (University of New England, Shared Decision Making Resources); Steve Edelman, MD (University of California at San Diego); Martha Funnell, RN, CD (University of Michigan); Vivian Fonseca, MD, FRCP (Tulane University); and William Polonsky, PhD, CDE (University of California, San Diego). The authors wish to acknowledge the contributions of Anne Farley (EPI-Q) in collecting data during the feasibility assessment; Chris Kabir (EPI-Q) for his assistance in tabulation and displaying feasibility assessment results; Jacquelyn Waugh and Dianna Dillinger (Emmi Solutions) for project management and writing during the development of the PDA; and Natalie Joseph-Williams (IPDAS) for facilitation throughout the submission and review process.
Disclosure
This research and report were developed with funding from Janssen Scientific Affairs, LLC. The authors report no other conflicts of interest in this work.