PURPOSE: Despite agreement that patient experiences should inform real-world study designs, best practices are lacking on how patient-provided information (PPI) translates into improved real-world evidence (RWE) studies. Discussion leaders will engage workshop participants on the challenges, opportunities, and methods for leveraging PPI to improve RWE.

DESCRIPTION: To improve the rigor of RWE, the Joint ISPOR-ISPE Special Task Force on RWE in Health Care Decision Making included stakeholder engagement as one of their recommendations for good procedural practices when designing, conducting, and disseminating RWE. Variable selection, cohort assembly, follow-up, and outcomes should reflect “real-world” patient experience and care delivery settings. RWE researchers interested in applying PPI want to leverage patient insights to improve RWE study design, e.g., administrative claims-based studies. Good practices exist on how to collect patient input, but do not exist on translating the input into specific study-design and/or methods considerations. To accomplish patient centricity in RWE, there is an urgent need to explore how to best translate PPI into specific study considerations.

Elisabeth Oehrlein will moderate the workshop and provide an overview of the topic with a case study on incorporating atrial fibrillation patient experiences into an RWE study design. Richard Willke will describe the intent of the ISPOR/ISPE Task Force on RWE’s recommendations for researchers and perspectives on moving the field forward. Chris Pashos and Prasun Subedi will build on their experiences to offer suggestions for incorporating PPI into RWE study designs using different types of datasets for different markets. Thereafter, we will facilitate a group discussion on the associated challenges and need for good practice methods considerations. Questions for discussion will include: Where/when are there opportunities to incorporate PPI in the RWE study-design continuum? Which PPI data sources should be used and when? What are objective approaches for translating PPI to study design or modification?