Strategies to Include Underrepresented Patient Populations in Patient-Centered Research


Xie R1, Dosreis S2, Regnante JM3, Neslusan C4, Malik ED5, Bright J6
1The Innovation and Value Initiative, Newton, MA, USA, 2University of Maryland School of Pharmacy, Baltimore, MD, USA, 3LUNGevity Foundation, Bethesda, MD, USA, 4Janssen Scientific Affairs, LLC, Titusville, NJ, USA, 5The Innovation and Value Initiative, Alexandria, VA, USA, 6Innovation and Value Initiative, Alexandria, VA, USA


Despite consensus across stakeholders on the need for greater inclusion of underrepresented populations in healthcare research, there continues to be inadequate participation from some patient subgroups (e.g., lower socioeconomic status, racial/ethnic minority). This qualitative study aimed to identify and summarize best practices in establishing criteria for a representative patient population and recruiting underrepresented patient subgroups.


A three-stage approach was used. First, we conducted a targeted search and sought input from two patient-centered research experts to identify guidance documents in the U.S. setting to extract insights on (1) how representativeness was defined, and (2) recommended strategies to overcome barriers in recruiting underrepresented subgroups. Twenty-three documents from nine organizations with extensive patient engagement and research experiences were reviewed. Second, we developed and administered a survey to a targeted group of individuals and organizations (N=26) with experiences in patient-centered research to prioritize the findings from stage one and identify gaps. Fourteen complete responses were received. Third, we aggregated findings from the first two stages to prioritize strategies to inform patient-centered research projects.


In defining representativeness of a data sample, guidelines recommended researchers to clearly define research objectives and pre-specify “who” and “how many” individuals to include as criteria, based on literature and engagement with patient and community-based organizations. Twelve patient characteristics (e.g., disability status) were identified to inform the criteria development. Practical strategies to recruit underrepresented patient populations were grouped by themes including partnership and patient engagement, personnel training, focus on accessibility, cross-validation, and activation and recognition of patient participants.


Improving representativeness in patient-centered research requires transformation. It requires an iterative approach where research teams engage with diverse patient communities at the outset, establish clear criteria, deliberately integrate findings, and communicate transparently to build trust and long-term relationships.

Conference/Value in Health Info

2021-11, ISPOR Europe 2021, Copenhagen, Denmark

Value in Health, Volume 24, Issue 12, S2 (December 2021)




Epidemiology & Public Health, Health Policy & Regulatory, Methodological & Statistical Research, Patient-Centered Research

Topic Subcategory

Health Disparities & Equity, Patient Engagement, Public Health, Survey Methods


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