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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.
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BackgroundHydroxychloroquine has recently received Emergency Use Authorization by the FDA and is currently prescribed in combination with azithromycin for COVID-19 pneumonia. We studied the safety of hydroxychloroquine, alone and in combination with azithromycin. MethodsNew user cohort studies were conducted including 16 severe adverse events (SAEs). Rheumatoid arthritis patients aged 18+ and initiating hydroxychloroquine were compared to those initiating sulfasalazine and followed up over 30 days. Self-controlled case series (SCCS) were conducted to further establish safety in wider populations. Separately, SAEs associated with hydroxychloroquine-azithromycin (compared to hydroxychloroquine-amoxicillin) were studied. Data comprised 14 sources of claims data or electronic medical records from Germany, Japan, Netherlands, Spain, UK, and USA. Propensity score stratification and calibration using negative control outcomes were used to address confounding. Cox models were fitted to estimate calibrated hazard ratios (CalHRs) according to drug use. Estimates were pooled where I2<40%. ResultsOverall, 956,374 and 310,350 users of hydroxychloroquine and sulfasalazine, and 323,122 and 351,956 users of hydroxychloroquine-azithromycin and hydroxychloroquine-amoxicillin were included. No excess risk of SAEs was identified when 30-day hydroxychloroquine and sulfasalazine use were compared. SCCS confirmed these findings. However, when azithromycin was added to hydroxychloroquine, we observed an increased risk of 30-day cardiovascular mortality (CalHR2.19 [1.22-3.94]), chest pain/angina (CalHR 1.15 [95% CI 1.05-1.26]), and heart failure (CalHR 1.22 [95% CI 1.02-1.45]) ConclusionsShort-term hydroxychloroquine treatment is safe, but addition of azithromycin may induce heart failure and cardiovascular mortality, potentially due to synergistic effects on QT length. We call for caution if such combination is to be used in the management of Covid-19. Trial registration numberRegistered with EU PAS; Reference number EUPAS34497 (http://www.encepp.eu/encepp/viewResource.htm?id=34498). The full study protocol and analysis source code can be found at https://github.com/ohdsi-studies/Covid19EstimationHydroxychloroquine. Funding sourcesThis research received partial support from the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC) and Senior Research Fellowship (DPA), US National Institutes of Health, Janssen Research & Development, IQVIA, and by a grant from the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea [grant number: HI16C0992]. Personal funding included Versus Arthritis [21605] (JL), MRC-DTP [MR/K501256/1] (JL), MRC and FAME (APU). The European Health Data & Evidence Network has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 806968. The JU receives support from the European Unions Horizon 2020 research and innovation programme and EFPIA. No funders had a direct role in this study. The views and opinions expressed are those of the authors and do not necessarily reflect those of the Clinician Scientist Award programme, NIHR, NHS or the Department of Health, England.
