抄録
Objective: Standardized clinical data are invaluable for secondary use of medical information. We constructed a standardized database and a data warehouse called D*D, based on the Standardized Structured Medical Information Exchange(SS-MIX)scheme. D*D enables physicians and researchers to perform complex searches with combined conditions, e.g. time to event. It contains data from 1999 for approximately 400,000 individual patients. The objective of this study was to provide an overview of the features of this database system, especially from the perspective of drug safety research.
Methods: Three models of research questions were identified from established drug-risk combinations:1)gatifloxacin and hypoglycemia;2)statins and rhabdomyolysis;and 3)oral 5-fluorouracil S-1 and hepatotoxicity. D*D was searched using predefined keywords and conditions.
Results: 1)A total of 3,635 patients were treated for diabetes. Among 20 diabetic patients prescribed gatifloxacin, hypoglycemia was recorded in one patient(1/38 prescriptions). 2)Among 5,926 patients who had been prescribed any statin within 10 years in our hospital, 6 patients(0.1%)experienced rhabdomyolysis. The incidence was similar to that for fibrate (1/740, 0.1%). The most confounded diagnosis was stiff shoulder. 3)Among 244 patients prescribed S-1, 19 patients(7.8%) experienced hepatotoxicity higher than CTCAE grade3 within 2 months from the prescription.
Conclusion: With limited data items and search keys in standardized data storage, definitions of exposures and outcomes require careful assessment during protocol development. Considering that the system can be implemented at more than half of the hospitals that have already installed ordering systems, D*D can be one of the Japanese models for distributed research network.
