The Missing Reality of Real Life in Real‐World Evidence

Abstract

Reality is defined as a real event, a real thing, or state of affairs. Reality exists in the places where we live our daily lives, in the relationships we have with others, and in our experiences, circumstances, and situations that occur across the lifespan. As the everydayness of our lives becomes increasingly digitized, data generated from the reality that exists outside of our healthcare encounters holds much promise to fill recognized gaps in real‐world evidence (RWE). In the past decade, many factors have converged to uniquely position person‐generated data for use in health care delivery, payment reform, product development, and regulatory decision making. Yet, real‐world data will fall short of its promise to fill gaps in RWE if what we learn does not reflect the real lives of real people from across the spectrum of social, economic, and cultural experiences.

Mobile-phone-based e-diary derived patient reported outcomes: Association with clinical disease activity, psychological status and quality of life of patients with multiple sclerosis

“…The advent of mobile electronic platforms opened up the possibility for interactive diaries that remind patients to enter data, prospectively collect information about patients' symptoms while at their natural environment and present a comprehensive reflection of disease status from the patients' perspective as part of the implementation of patient centric approach and participatory medicine [1][2][3][4]. As the everydayness of our lives becomes increasingly digitized, data generated outside of healthcare encounters holds promise to fill recognized gaps in real-world evidence [5].…”

What Does It Take to Transform Real‐World Data Into Real‐World Evidence?

“…Engaging patients while designing and implementing real‐world studies is beneficial for all stakeholders involved. As Nowell and Okun point out, patients are in the best position to provide real‐world input on the performance of a therapeutic product. Beyond just safety and effectiveness, patients and caregivers can provide feedback on patient satisfaction and quality of life.…”

“…However, these RWD need to be collected in a systematic and standardized way such that they become high‐quality data and, consequently, a substantial source of RWE . The RWE that is generated needs to be translated into actions that can improve the everyday life of patients . As Shaywitz notes, this also calls for patient‐oriented investigators who have a patient‐focused vision and are willing to put the patients at the center of this ongoing conversation.…”

Developing Patient-Centered Real-World Evidence: Emerging Methods Recommendations From a Consensus Process

“…15 Nevertheless, even these more advanced data sets are prone to missing information and lack context regarding whether or why subjects delay treatment or are nonadherent to care plans or how other life factors, including social determinants of health, affect satisfaction, experiences, and outcomes. 18 Context regarding patient experiences is still needed to explain data trends. 18 A low-cost but underutilized approach to enhance the quality of RWD studies involves applying the information provided by patients about their experiences, derived through qualitative research, when designing quantitative RWD-based studies.…”