Utilization of Geospatial Distribution in the Measurement of Study Cohort Representativeness

Objective: The ability to apply results from a study to a broader population remains a primary objective in translational science. Distinct from intrinsic elements of scientific rigor, the extrinsic concept of generalization requires there be alignment between a study cohort and population in which results are expected to be applied. Widespread efforts have been made to quantify representativeness of study cohorts. These techniques, however, often consider the study and target cohorts as monolithic collections that can be directly compared. Overlooking known impacts to health from socio-demographic and environmental factors tied to individual's geographical location, and potentially obfuscating misalignment in underrepresented population subgroups. This manuscript introduces several measures to account for geographic information in the assessment of cohort representation. Methods: Metrics were defined across two themes: First, measures of recruitment, to assess if a study cohort is drawn at an expected rate and in an expected geographical pattern with respect to individuals in a reference cohort. Second, measures of individual characteristics, to assess if the individuals in the study cohort accurately reflect the sociodemographic, clinical, and geographic diversity observed across a reference cohort while accounting for the geospatial proximity of individuals. Results: As an empirical demonstration, methods are applied to an active clinical study examining asthma in Black/African American patients at a US Midwestern pediatric hospital. Results illustrate how areas of over- and under-recruitment can be identified and contextualized in light of study recruitment patterns at an individual- level, highlighting the ability to identify a subset of features for which the study cohort closely resembled the broader population. In addition they provide an opportunity to dive deeper into misalignments, to identify study cohort members that are in some way distinct from the communities for which they are expected to represent. Conclusion: Together, these metrics provide a comprehensive spatial assessment of a study cohort with respect to a broader target population. Such an approach offers researchers a toolset by which to target expected generalization of results derived from a given study.