Abstract
In Japan, since the Next Generation Medical Infrastructure Act regarding anonymized medical data contributing to R&D came into force in 2018, it is expected to exploit medical data for R&D. The Millennial Medical Record Project has been collected a large amount of standardized medical data of a number of hospitals stored in a database under the act. In order for users to widely exploit the medical data when carrying out trial-and-error, there is a difficulty of data access because of a highly secured management of non-anonymous medical data. To solve the data access problem, we develop a general statistical analytical system for executing a variety of statistical significance tests with statistical power analysis in an environment of trial-and-error for users’ analyses without programming. In the analytical system, the front-end is a registration form as the input and the analysis results as the output on Microsoft Excel, and the back-end is based on Python, R and SQL. Although the fixed registration form covers limited application for the analysis, since the analysis results using the stored Millennial Medical Record data is provided in a short time without collecting the necessary data for the analysis, the exploitation of medical data could widely and rapidly promote by medical experts/researchers in the manner of trial-and-error. The developed system could apply to make protocols for clinical research and clinical trial, and the potential to discover real-world evidence could be increased.
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Acknowledgements
This work was supported by JSPS KAKENHI Grant Number JP18K09948.
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This work was supported by JSPS KAKENHI Grant Number JP18K09948.
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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. For this type of study, formal consent is not required.
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This study was approved by the authors’ research ethics committee (University of Miyazaki). Moreover, the authors were asked to obtain informed consent as follows: informed consent was obtained by opt-out method. Concretely, the authors noticed details of this study on their website and asked participants to offer the authors not to use their information until the specified date. After this date, the authors could use information without patients who asked us not to use.
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Matsuo, R., Yamazaki, T. & Araki, K. Development of a General Statistical Analytical System Using Nationally Standardized Medical Information. J Med Syst 45, 66 (2021). https://doi.org/10.1007/s10916-021-01742-7
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DOI: https://doi.org/10.1007/s10916-021-01742-7