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Related Experiment Video

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

Elizabeth H Golembiewski1,2, Mindy M Mickelson3, Juan P Brito1,4

  • 1Knowledge and Evaluation Research (KER) Unit, Mayo Clinic, Rochester, MN, USA.

Journal of Clinical and Translational Science
|January 10, 2025
PubMed
Summary

Engaging patients and stakeholders in comparative effectiveness research (CER) using real-world data (RWD) is crucial. A Patient and Stakeholder Advisory Group (PSAG) improved study design and relevance for type 2 diabetes (T2D) research.

Keywords:
Patient and stakeholder engagementcomparative effectiveness researchpatient-centered outcomesreal-world datatype 2 diabetes

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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.