A Workshop on Developing Patient-Centered Real-World Evidence: Consensus Recommendations and Case Examples

Speaker(s)

Discussion Leader: Richard Willke, PhD, ISPOR, Lawrenceville, NJ, USA
Discussants: Elisabeth Oehrlein, PhD, MS, Applied Patient Experience, LLC, Washington, DC, USA; Mehmet Burcu, PhD, MS, Merck & Co., Inc., West Point, PA, USA; Alison Bourke, BSc MSc, International Society for Pharmacoepidemiology (ISPE), London, UK

PURPOSE: The Joint ISPOR-ISPE Special Task Force on RWE included patient/stakeholder engagement as a recommended good procedural practice when designing, conducting, and disseminating real-world evidence (RWE). This workshop will introduce consensus recommendations and present case examples for developing patient-centered RWE.

DESCRIPTION: Interest in applying real-world evidence (RWE) in decision-making has grown among health care stakeholders over the past two decades. RWE generated from high-quality and reliable real-world data (RWD) can provide insights for a range of uses. Despite its growing use, there are well-known challenges associated with producing high-quality RWE. RWD sources usually include healthcare encounter data, including treatments, tests, and diagnoses, but often lack other important information such as the patient's diet, adherence, quality of life, and other experiences and behavioral data. To improve the rigor of RWE studies, variable selection, cohort assembly, follow-up, and outcomes should reflect “real-world” patient experience and care delivery settings. In addition, Patient-Generated Health Data (PGHD) is becoming more readily available. Incorporating PGDH into ‘traditional’ RWD sources offers opportunities to uncover complex factors involved in health, safety and effectiveness of treatments, underpinned by a patient centric view to more fully understand patient choices.

Richard Willke will moderate the session, provide an overview of the topic, describe the intent of the ISPOR/ISPE Task Force on RWE’s recommendations and perspectives on advancing the field. Elisabeth Oehrlein will discuss 13-consensus recommendations developed in collaboration with representatives from patient organizations, ISPOR-ISPE task force members, and health technology/value assessors on how patient experiences/insights can be incorporated into the design, conduct, and translation of real-world research that reflects patients’ lived experience. Mehmet Burcu and Alison Bourke will describe RWE use cases and suggestions for incorporating patient experience and PGHD into RWD sources and RWE study designs, along with challenges and practical issues such as data linking, validation, and analysis.

Code

105

Topic

Patient-Centered Research