Development and validation of a management system and dataset quality assessment tool for the Radiology Common Data Model (R_CDM): A case study in liver disease

Background: The Observational Medical Outcomes Partnership-Common Data Model (OMOP-CDM), a distrib-uted research network, has low clinical data coverage. Radiological data are valuable, but imaging metadata are often incomplete, and a standardized recording format in the OMOP-CDM is lacking. We developed a web-based management system and data quality assessment (RQA) tool for a radiology_CDM (R_CDM) and evaluated the feasibility of clinically applying this dataset. Methods: We designed an R_CDM with Radiology_Occurrence and Radiology_Image tables. This was seamlessly linked to the OMOP-CDM clinical data. We adopted the standardized terminology using the RadLex playbook and mapped 5,753 radiology protocol terms to the OMOP vocabulary. An extract, transform, and load (ETL) process was developed to extract detailed information that was difficult to extract from metadata and to compensate for missing values. Image-based quantification was performed to measure liver surface nodularity (LSN), using customized Wonkwang abdomen and liver total solution (WALTS) software. Results: On a PACS, 368,333,676 DICOM files (1,001,797 cases) were converted to R_CDM chronic liver disease (CLD) data (316,596 MR images, 228 cases; 926,753 CT images, 782 cases) and uploaded to a web-based management system. Acquisition date and resolution were extracted accurately, but other information, such as "contrast administration status" and "photography direction", could not be extracted from the metadata. Using WALTS, 9,609 pre-contrast axial-plane abdominal MR images (197 CLD cases) were assigned LSN scores by METAVIR fibrosis grades, which differed significantly by ANOVA (p < 0.001). The mean RQA score (83.5) indicated good quality. Conclusion: This study developed a web-based system for management of the R_CDM dataset, RQA tool, and constructed a CLD R_CDM dataset, with good quality for clinical application. Our management system and R_CDM CLD dataset would be useful for multicentric and image-based quantification researches.