(053) Identification of Cohorts for Ulcerative Colitis, Diabetes, and Small Cell Lung Cancer With Corresponding Demographic and Geographic Distributions From a Nationally Representative U.S. Pharmacy Database

Background: Participant identification for pharmacoepidemiology studies and clinical trials is often problematic with respect to sample size and demographic targets. An alternative recruitment method based on identifiable participant contact information, demographic information, and geographic distribution from a database of approximately 131 million active customers in the United States is presented for calendar year 2023.

Objectives: To determine cohort sizes, demographic distributions, and high-density geographic areas for potential participants in pharmacoepidemiology and clinical trials for ulcerative colitis, diabetes, and small cell lung cancer.

Methods: A descriptive analytic design was used to define disease cohorts for ulcerative colitis, diabetes, and small cell lung cancer. Potential participants were identified from a large nationally representative retail and specialty pharmacy serving 131 million customers with 98% contact information providing informed consent to be notified of studies matching their medical conditions. Potential participants were identified utilizing ICD-10 codes or ATC codes for medication utilization. Total participants and percentage of participants by age strata, race and sex were calculated. Geographic footprint (between states) were analyzed based on 2023 US data.

Results: Assessment of the ulcerative colitis identified approximately 511,000 potential participants. Distribution by race were White (>60%) Black (12%) and Hispanic (19%). Females comprised approximately 60% in all age strata 18+. Geographic density was highest in Texas, Florida, California, and New York. Assessment of the diabetes cohort identified approximately 6.7 million customers with the highest number in the 50 to 64 year age strata. Distribution by race were White (58%), Hispanics (20%), Blacks (14%), and Asians (5%). Females comprised the majority of the cohort across all age groups (52 to 74%) with an overall average of 56%. Geographic distribution was highest in the South and Illinois. The small cell lung cancer cohort identified 41,484 participants with the highest numbers in the 65 to 74 year age strata. Whites comprised the majority of participants (63%) with Blacks and Hispanics comprising 13% and 14%, respectively. Data are presented in color coded high outputs and GIS derived maps.

Conclusions: Leveraging diagnostic codes and treatment utilization within large retail and specialty pharmacy data can provide valuable insights into participant recruitment. Limitations include treatment seeking behaviors within populations and potential misclassification of conditions. Treatment and diagnosis delivered outside the pharmacy system are not available for evaluation without linkages to external real-world data sources.