Multidisciplinary stakeholder engagement in a type 2 diabetes comparative effectiveness study utilizing real-world...

Area of Science:

• Health Services Research
• Comparative Effectiveness Research
• Real-World Data Studies

Background:

• Patient and stakeholder involvement is vital for comparative effectiveness research (CER).
• Examples of engaging diverse stakeholders in CER using real-world data (RWD) are limited.
• CER studies using RWD present unique challenges for stakeholder engagement due to technical complexity and minimal prospective data collection.

Purpose of the Study:

• To describe patient and stakeholder engagement in a type 2 diabetes (T2D) CER study utilizing RWD.
• To assess the impact of a Patient and Stakeholder Advisory Group (PSAG) on study design and conduct.
• To evaluate PSAG member satisfaction and perceived goals.

Main Methods:

• Formation of a 12-member PSAG including patients with T2D, clinicians, health system leaders, professional society representatives, and a payer representative.
• PSAG guided study design, conduct, and dissemination for a T2D CER study using administrative claims data.
• Post-study survey administered to PSAG members to assess participation goals and experiences.

Main Results:

• PSAG members influenced critical study decisions, including cohort selection and the addition of a patient preference elicitation aim.
• High satisfaction reported by PSAG members regarding engagement processes.
• Key goals for PSAG members included impacting the lives of individuals with T2D and ensuring clinical relevance.

Conclusions:

• Best practices for stakeholder engagement in RWD-based CER are still developing.
• An inclusive, stakeholder-engaged approach enhances CER by integrating diverse perspectives.
• Future work will focus on long-term engagement outcomes and sustained PSAG member satisfaction.