Park ChulHyoung, Lee So Hee, Lee Da Yun, Choi Seoyoon, You Seng Chan, Jeon Ja Young, Park Sang Jun, Park Rae Woong
Department of Biomedical Informatics, Ajou University School of Medicine, 206, Worldcup-ro, Yeongtong-gu, Suwon, 16499, Republic of Korea, 82 31-219-4471.
Department of Biomedical Sciences, Ajou University Graduate School of Medicine, Suwon, Republic of Korea.
JMIR Med Inform. 2025 Feb 21;13:e64422. doi: 10.2196/64422.
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, using 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 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 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 patients with chronic diseases and control groups, performing large-scale 1:2 propensity score matching (PSM). Subsequently, we linked the 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 R-CDM format. 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 1603 patients. During the follow-up period, significant reductions in CMT were observed in the T2DM cohorts at AUMC (P=.04) and SNUBH (P=.007), without significant changes in RNFL thickness (AUMC: P=.56; SNUBH: P=.39). Notably, a significant reduction in CMT during the follow-up was observed only at AUMC in the hypertension cohort, compared to the control group (P=.04); no other significant differences in retinal thickness were found in the remaining analyses.
The significance of our study lies in demonstrating the efficiency of multi-institutional collaborative research that simultaneously uses clinical data and medical imaging data by leveraging the OMOP-CDM for standardizing EMR data and the R-CDM for standardizing medical imaging data.
观察性医学结局伙伴通用数据模型(OMOP-CDM)是用于统一电子病历(EMR)数据的国际标准。然而,由于它没有对诸如医学影像等非结构化数据进行标准化,因此在多机构合作研究中使用这些数据具有挑战性。为了克服这一限制,诸如放射学通用数据模型(R-CDM)之类的扩展已出现,以纳入并标准化这些数据类型。
本研究旨在证明,通过将光学相干断层扫描(OCT)数据标准化为R-CDM格式,可以高效地开展多机构合作研究,分析长期慢性病患者视网膜厚度的变化。
我们使用R-CDM将从两家三级医院收集的用于研究目的的OCT图像进行了标准化。作为概念验证,我们对患有慢性病的患者和未患慢性病的患者的视网膜厚度进行了对比分析。被诊断或治疗过可能影响视网膜厚度的视网膜和脉络膜疾病的患者被排除在分析之外。我们利用各机构现有的OMOP-CDM,提取了慢性病患者队列和对照组,进行大规模1:2倾向得分匹配(PSM)。随后,我们将OMOP-CDM和R-CDM相链接,提取这些队列的OCT图像数据,并使用线性混合模型分析中心黄斑厚度(CMT)和视网膜神经纤维层(RNFL)厚度。
蔚山大学医学院(AUMC)的261,874张图像和首尔国立大学盆唐医院(SNUBH)的475,626张图像的OCT数据被标准化为R-CDM格式。各机构建立的R-CDM数据库与OMOP-CDM数据库相链接。经过1:2 PSM后,2型糖尿病(T2DM)队列包括957名患者,对照组有1603名患者。在随访期间,AUMC(P = 0.04)和SNUBH(P = 0.007)的T2DM队列中CMT显著降低,而RNFL厚度无显著变化(AUMC:P = 0.56;SNUBH:P = 0.39)。值得注意的是,与对照组相比,仅在AUMC的高血压队列中观察到随访期间CMT显著降低(P = 0.04);在其余分析中未发现视网膜厚度的其他显著差异。
我们研究的意义在于,通过利用OMOP-CDM对EMR数据进行标准化以及利用R-CDM对医学影像数据进行标准化,证明了同时使用临床数据和医学影像数据的多机构合作研究的效率。