Enhancing Patient Centricity of Real-World Data Research: An Exploratory Analysis Using the Patient Experience Mapping Toolbox

• Published in: Value in health Vol. 26; no. 1; pp. 10 - 17
• Main Authors: Oehrlein, Elisabeth M., Burcu, Mehmet, Schoch, Silke, Gressler, Laura Elisabeth
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.01.2023
• Subjects: Humans; observational study; Patient Outcome Assessment; patient-centered care; patient-centered outcomes research; Patients; pharmacoepidemiology; patient-centered care; patient-centered outcomes research; observational study; pharmacoepidemiology
• ISSN: 1098-3015; 1524-4733
• DOI: 10.1016/j.jval.2022.10.002

There is an increasing expectation that medical product development and assessment be guided by patient input captured through patient engagement. Recently published consensus guidelines describe how qualitative patient experience data (PED) can guide the design, conduct, and translation of real-world research that reflects patients’ lived experience. The objective of this exploratory analysis is to examine how researchers could leverage PED captured through the Patient Experience Mapping Toolbox (PEMT) to guide real-world data (RWD) research designs. This exploratory analysis included a thematic analysis of interview transcripts collected while pilot testing the PEMT followed by a qualitative analysis of the emerging themes aligned with stages listed in the patient-centered real-world evidence, Real-World Research Design Framework. PED collected using the PEMT include information about symptomology, interactions with the healthcare system, information-seeking behavior, misdiagnoses, lifestyle changes, treatments, side effects, and comorbidities. This information can be leveraged at key study design decisions, including (1) identifying study cohorts and subgroups, (2) identifying exposures, (3) informing covariates and potential confounders; and (4) refining study periods. Additionally, participants described where they seek information about treatments and diseases, which should inform dissemination strategies. We identified opportunities for PED collected using the PEMT to inform RWD study designs. The PED described in this exploratory analysis stem from pilot testing of the PEMT across a variety of conditions. In the next phase of development in this area, researchers should evaluate how data collected using the PEMT can be applied to RWD research for a specific disease. •Patients and other healthcare stakeholders increasingly expect patient-centered research and healthcare delivery.•High-quality data on patients’ experiences, priorities, and desired outcomes reported by patients are relevant to the design, conduct, and translation of real-world research but are often not collected or captured in traditional real-world databases.•Applying qualitative patient experience data is one opportunity to make informed study design decisions, even in the absence of more comprehensive databases that include patient-generated health data.