Analysis of Retinal Thickness in Patients with Chronic Diseases Using Standardized Optical Coherence Tomography Databases Based on the Radiology Common Data Model (R-CDM) (Preprint)

Abstract

The Observational Medical Outcome Partners - Common Data Model (OMOP-CDM) is an international standard for harmonizing electronic medical record (EMR) data. However, since it does not standardize unstructured data such as medical imaging, utilizing this data in multi-institutional collaborative research becomes challenging. To overcome this limitation, extensions such as the Radiology Common Data Model (R-CDM) have emerged to include and standardize these data types.

This work aims to demonstrate that by standardizing Optical Coherence Tomography (OCT) data into an R-CDM format, multi-institutional collaborative studies analyzing changes in retinal thickness in patients with long-standing chronic diseases can be performed very efficiently.

We standardized OCT images collected from two tertiary hospitals for research purposes using the R-CDM. As a proof of concept, we conducted a comparative analysis of retinal thickness between patients who have long suffered from chronic diseases and those who have not. Patients diagnosed or treated for retinal and choroidal diseases, which could affect retinal thickness, were excluded from the analysis. Using the existing OMOP-CDM at each institution, we extracted cohorts of chronic disease patients and control groups, performing large-scale 1:2 propensity score matching (PSM). Subsequently, we linked OMOP-CDM and R-CDM to extract the OCT image data of these cohorts and analyzed central macular thickness (CMT) and retinal nerve fiber layer (RNFL) thickness using a linear mixed model.

OCT data of 261,874 images from Ajou University Medical Center (AUMC) and 475,626 images from Seoul National University Bundang Hospital (SNUBH) were standardized in the form of R-CDM. The R-CDM databases established at each institution were linked with the OMOP-CDM database. Following 1:2 PSM, the type 2 diabetes mellitus (T2DM) cohort included 957 patients, and the control cohort had 1,603 patients. During the follow-up period, significant reductions in CMT were observed in the T2DM cohorts at both institutions (P = 0.04 and P < 0.01, respectively), without significant changes in RNFL thickness (P = 0.56 and P = 0.39, respectively). Notably, a significant reduction in CMT during the follow-up was observed only at AUMC in the hypertension (HTN) cohort, compared to the control group; no other significant differences in retinal thickness changes were found in the remaining analyses.

The significance of our study lies in demonstrating the efficiency of multi-institutional collaborative research that simultaneously utilizes clinical data and medical imaging data by leveraging the OMOP-CDM for standardizing EMR data, and the R-CDM for standardizing medical imaging data.