Development and Validation of the Radiology Common Data Model (R-CDM) for the International Standardization of Medical Imaging Data

Purpose@#Digital Imaging and Communications in Medicine (DICOM), a standard file format for medical imaging data, contains metadata describing each file. However, metadata are often incomplete, and there is no standardized format for recording metadata, leading to inefficiency during the metadata-based data retrieval process. Here, we propose a novel standardization method for DICOM metadata termed the Radiology Common Data Model (R-CDM). @*Materials and Methods@#R-CDM was designed to be compatible with Health Level Seven International (HL7)/Fast Healthcare Interoperability Resources (FHIR) and linked with the Observational Medical Outcomes Partnership (OMOP)-CDM to achieve a seamless link between clinical data and medical imaging data. The terminology system was standardized using the RadLex playbook, a comprehensive lexicon of radiology. As a proof of concept, the R-CDM conversion process was conducted with 41.7 TB of data from the Ajou University Hospital. The R-CDM database visualizer was developed to visualize the main characteristics of the R-CDM database. @*Results@#Information from 2801360 cases and 87203226 DICOM files was organized into two tables constituting the R-CDM. Information on imaging device and image resolution was recorded with more than 99.9% accuracy. Furthermore, OMOP-CDM and RCDM were linked to efficiently extract specific types of images from specific patient cohorts. @*Conclusion@#R-CDM standardizes the structure and terminology for recording medical imaging data to eliminate incomplete and unstandardized information. Successful standardization was achieved by the extract, transform, and load process and image classifier. We hope that the R-CDM will contribute to deep learning research in the medical imaging field by enabling the securement of large-scale medical imaging data from multinational institutions.

Perceived Risk of Re-Identification in OMOP-CDM Database: A CrossSectional Survey

Background@#The advancement of information technology has immensely increased the quality and volume of health data. This has led to an increase in observational study, as well as to the threat of privacy invasion. Recently, a distributed research network based on the common data model (CDM) has emerged, enabling collaborative international medical research without sharing patient-level data. Although the CDM database for each institution is built inside a firewall, the risk of re-identification requires management. Hence, this study aims to elucidate the perceptions CDM users have towards CDM and risk management for re-identification. @*Methods@#The survey, targeted to answer specific in-depth questions on CDM, was conducted from October to November 2020. We targeted well-experienced researchers who actively use CDM. Basic statistics (total number and percent) were computed for all covariates. @*Results@#There were 33 valid respondents. Of these, 43.8% suggested additional anonymization was unnecessary beyond, “minimum cell count” policy, which obscures a cell with a value lower than certain number (usually 5) in shared results to minimize the liability of re-identification due to rare conditions. During extract-transform-load processes, 81.8% of respondents assumed structured data is under control from the risk of re-identification. However, respondents noted that date of birth and death were highly re-identifiable information. The majority of respondents (n = 22, 66.7%) conceded the possibility of identifier-contained unstructured data in the NOTE table. @*Conclusion@#Overall, CDM users generally attributed high reliability for privacy protection to the intrinsic nature of CDM. There was little demand for additional de-identification methods. However, unstructured data in the CDM were suspected to have risks. The necessity for a coordinating consortium to define and manage the re-identification risk of CDM was urged.

Incorporation of Korean Electronic Data Interchange Vocabulary into Observational Medical Outcomes Partnership Vocabulary / 대한의료정보학회지

Objectives@#We incorporated the Korean Electronic Data Interchange (EDI) vocabulary into Observational Medical Outcomes Partnership (OMOP) vocabulary using a semi-automated process. The goal of this study was to improve the Korean EDI as a standard medical ontology in Korea. @*Methods@#We incorporated the EDI vocabulary into OMOP vocabulary through four main steps. First, we improved the current classification of EDI domains and separated medical services into procedures and measurements. Second, each EDI concept was assigned a unique identifier and validity dates. Third, we built a vertical hierarchy between EDI concepts, fully describing child concepts through relationships and attributes and linking them to parent terms. Finally, we added an English definition for each EDI concept. We translated the Korean definitions of EDI concepts using Google.Cloud.Translation.V3, using a client library and manual translation. We evaluated the EDI using 11 auditing criteria for controlled vocabularies. @*Results@#We incorporated 313,431 concepts from the EDI to the OMOP Standardized Vocabularies. For 10 of the 11 auditing criteria, EDI showed a better quality index within the OMOP vocabulary than in the original EDI vocabulary. @*Conclusions@#The incorporation of the EDI vocabulary into the OMOP Standardized Vocabularies allows better standardization to facilitate network research. Our research provides a promising model for mapping Korean medical information into a global standard terminology system, although a comprehensive mapping of official vocabulary remains to be done in the future.

COVID-19 International Collaborative Research by the Health Insurance Review and Assessment Service Using Its Nationwide Real-world Data: Database, Outcomes, and Implications / 예방의학회지

This article aims to introduce the inception and operation of the COVID-19 International Collaborative Research Project, the world’s first coronavirus disease 2019 (COVID-19) open data project for research, along with its dataset and research method, and to discuss relevant considerations for collaborative research using nationwide real-world data (RWD). COVID-19 has spread across the world since early 2020, becoming a serious global health threat to life, safety, and social and economic activities. However, insufficient RWD from patients was available to help clinicians efficiently diagnose and treat patients with COVID-19, or to provide necessary information to the government for policy-making. Countries that saw a rapid surge of infections had to focus on leveraging medical professionals to treat patients, and the circumstances made it even more difficult to promptly use COVID-19 RWD. Against this backdrop, the Health Insurance Review and Assessment Service (HIRA) of Korea decided to open its COVID-19 RWD collected through Korea’s universal health insurance program, under the title of the COVID-19 International Collaborative Research Project. The dataset, consisting of 476 508 claim statements from 234 427 patients (7590 confirmed cases) and 18 691 318 claim statements of the same patients for the previous 3 years, was established and hosted on HIRA’s in-house server. Researchers who applied to participate in the project uploaded analysis code on the platform prepared by HIRA, and HIRA conducted the analysis and provided outcome values. As of November 2020, analyses have been completed for 129 research projects, which have been published or are in the process of being published in prestigious journals.

Comparison of First-Line Dual Combination Treatments in Hypertension: Real-World Evidence from Multinational Heterogeneous Cohorts

BACKGROUND AND OBJECTIVES@#2018 ESC/ESH Hypertension guideline recommends 2-drug combination as initial anti-hypertensive therapy. However, real-world evidence for effectiveness of recommended regimens remains limited. We aimed to compare the effectiveness of first-line anti-hypertensive treatment combining 2 out of the following classes: angiotensin-converting enzyme (ACE) inhibitors/angiotensin-receptor blocker (A), calcium channel blocker (C), and thiazide-type diuretics (D).@*METHODS@#Treatment-naïve hypertensive adults without cardiovascular disease (CVD) who initiated dual anti-hypertensive medications were identified in 5 databases from US and Korea. The patients were matched for each comparison set by large-scale propensity score matching. Primary endpoint was all-cause mortality. Myocardial infarction, heart failure, stroke, and major adverse cardiac and cerebrovascular events as a composite outcome comprised the secondary measure.@*RESULTS@#A total of 987,983 patients met the eligibility criteria. After matching, 222,686, 32,344, and 38,513 patients were allocated to A+C vs. A+D, C+D vs. A+C, and C+D vs. A+D comparison, respectively. There was no significant difference in the mortality during total of 1,806,077 person-years: A+C vs. A+D (hazard ratio [HR], 1.08; 95% confidence interval [CI], 0.97−1.20; p=0.127), C+D vs. A+C (HR, 0.93; 95% CI, 0.87−1.01; p=0.067), and C+D vs. A+D (HR, 1.18; 95% CI, 0.95−1.47; p=0.104). A+C was associated with a slightly higher risk of heart failure (HR, 1.09; 95% CI, 1.01−1.18; p=0.040) and stroke (HR, 1.08; 95% CI, 1.01−1.17; p=0.040) than A+D.@*CONCLUSIONS@#There was no significant difference in mortality among A+C, A+D, and C+D combination treatment in patients without previous CVD. This finding was consistent across multi-national heterogeneous cohorts in real-world practice.

Comparison of First-Line Dual Combination Treatments in Hypertension: Real-World Evidence from Multinational Heterogeneous Cohorts

BACKGROUND AND OBJECTIVES: 2018 ESC/ESH Hypertension guideline recommends 2-drug combination as initial anti-hypertensive therapy. However, real-world evidence for effectiveness of recommended regimens remains limited. We aimed to compare the effectiveness of first-line anti-hypertensive treatment combining 2 out of the following classes: angiotensin-converting enzyme (ACE) inhibitors/angiotensin-receptor blocker (A), calcium channel blocker (C), and thiazide-type diuretics (D).METHODS: Treatment-naïve hypertensive adults without cardiovascular disease (CVD) who initiated dual anti-hypertensive medications were identified in 5 databases from US and Korea. The patients were matched for each comparison set by large-scale propensity score matching. Primary endpoint was all-cause mortality. Myocardial infarction, heart failure, stroke, and major adverse cardiac and cerebrovascular events as a composite outcome comprised the secondary measure.RESULTS: A total of 987,983 patients met the eligibility criteria. After matching, 222,686, 32,344, and 38,513 patients were allocated to A+C vs. A+D, C+D vs. A+C, and C+D vs. A+D comparison, respectively. There was no significant difference in the mortality during total of 1,806,077 person-years: A+C vs. A+D (hazard ratio [HR], 1.08; 95% confidence interval [CI], 0.97−1.20; p=0.127), C+D vs. A+C (HR, 0.93; 95% CI, 0.87−1.01; p=0.067), and C+D vs. A+D (HR, 1.18; 95% CI, 0.95−1.47; p=0.104). A+C was associated with a slightly higher risk of heart failure (HR, 1.09; 95% CI, 1.01−1.18; p=0.040) and stroke (HR, 1.08; 95% CI, 1.01−1.17; p=0.040) than A+D.CONCLUSIONS: There was no significant difference in mortality among A+C, A+D, and C+D combination treatment in patients without previous CVD. This finding was consistent across multi-national heterogeneous cohorts in real-world practice.

Olmesartan is not associated with the risk of enteropathy: a Korean nationwide observational cohort study

BACKGROUND/AIMS: Olmesartan, a widely used angiotensin II receptor blocker (ARB), has been linked to sprue-like enteropathy. No cases of olmesartan-associated enteropathy have been reported in Northeast Asia. We investigated the associations between olmesartan and other ARBs and the incidence of enteropathy in Korea. METHODS: Our retrospective cohort study used data from the Korean National Health Insurance Service to identify 108,559 patients (58,186 females) who were initiated on angiotensin converting enzyme inhibitors (ACEis), olmesartan, or other ARBs between January 2005 and December 2012. The incidences of enteropathy were compared among drug groups. Changes in body weight were compared after propensity score matching of patients in the ACEis and olmesartan groups. RESULTS: Among 108,559 patients, 31 patients were diagnosed with enteropathy. The incidences were 0.73, 0.24, and 0.37 per 1,000 persons, in the ACEis, olmesartan, and other ARBs groups, respectively. Adjusted rate ratios for enteropathy were: olmesartan, 0.33 (95% confidential interval [CI], 0.10 to 1.09; p = 0.070) and other ARBs, 0.34 (95% CI, 0.14 to 0.83; p = 0.017) compared to the ACEis group after adjustment for age, sex, income level, and various comorbidities. The post hoc analysis with matched cohorts revealed that the proportion of patients with significant weight loss did not differ between the ACEis and olmesartan groups. CONCLUSIONS: Olmesartan was not associated with intestinal malabsorption or significant body weight loss in the general Korean population. Additional large-scale prospective studies of the relationship between olmesartan and the incidence of enteropathy in the Asian population are needed.

Transvascular Implantation of an Implantable Cardioverter-Defibrillator in a Patient Who has Undergone One-and-a-Half Ventricle Repair

Implantable cardioverter-defibrillator (ICD) therapy is acknowledged as a valid treatment method for the effective prevention of sudden cardiac death, which is a major cause of mortality in adult congenital heart disease patients. But ICD implantation by the conventional transvascular approach is not always possible in patients who have undergone palliative surgery due to congenital and structural heart disease. Here, we report a case in which an ICD was transvascularly implanted in an arrhythmogenic right ventricular cardiomyopathy patient who had undergone a one-and-a-half ventricle repair.