Design of and rationale for the Japan Diabetes compREhensive database project based on an Advanced electronic Medical record System (J-DREAMS)
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The “Japan Diabetes compREhensive database project based on an Advanced electronic Medical record System” is a registry of patients with diabetes in Japan. The characteristics of this registry include a clinical information input process using the template function of an electronic medical record (EMR) system [the standard diabetes management template (SDMT)], a standardized exchangeable information storage format [the Standardized Structured Medical Information eXchange 2 (SS-MIX2)], and a secure and efficient information extraction process [Multipurpose Clinical Data Repository System (MCDRS)]. Together, these characteristics enable efficient data input during routine patient consultations, efficient and exact data extraction from each facility, and the integration of data across different facilities even though these data were generated by EMR systems from different vendors. The SDMT collects clinical information including the type of diabetes, body height and weight, blood pressure, lifestyle, and comorbidities. Completing this template triggers the automatic collection of other information such as fundamental information (sex, year and month of birth, and facility), prescription information, and laboratory examination results. As the information from every routine consultation is saved with an anonymized patient ID, linked data can be used as panel data allowing longitudinal investigations. The data obtained from the registry will allow analyses, for exmaple, mortality and morbidity risk, by various characteristics or drug types and may reveal unmet needs that inform future diabetes care.
KeywordsDiabetes Registry Japan Medical informatics Electronic medical record SS-MIX2
The J-DREAMS investigators would like to thank all physicians, faculties of medical informatics department, and their staffs at the participating institutions for their cooperation and assistance in the conduct of the study. Heartfelt thanks are also due to all patients with diabetes from all parts of Japan for their participation in the study.
J-DREAMS is a research project driven by NCGM. NCGM and the JDS established a joint committee, within which members discuss the detail of study design and analysis from a scientific perspective.
The study was supported by a Ministry of Health, Labour and Welfare grant-in-aid during Fiscal Year 2014, Japan Agency for Medical Research and Development (AMED) Practical Research Project for Life-Style-Related Diseases including Cardiovascular Diseases and Diabetes Mellitus during Fiscal Years 2015–2016, and a grant for NCGM (28A-1205) during Fiscal Years 2016–2018. The development of MCDRS and SS-MIX2 implementation is partially supported by the Center of Innovation Program from the Japan Science and Technology Agency, JST.
Compliance with ethical standards
Conflict of interest
Kayo Waki received a clinical research grant from NTT Docomo. The other authors declare that they have no conflict of interest.
Human rights statement and informed consent
All procedures followed were in accordance with Ethical Guidelines for Medical and Health Research Involving Human Subjects of 2014 and its revision of 2017 and with the Helsinki Declaration of 1964 and later versions. Based on the ethical guidelines, an opt-out consent method was chosen. By displaying posters in hospitals or through websites, patients were informed of the objectives of the study, and permission for the investigators to collect PMR data was sought. We offered opportunity for the participants to opt out of participation in the registry by filling out the opt-out form.
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