Characterization and selection of Japanese electronic health record databases used as data sources for non-interventional observational studies

Table 1 Summary of the data source used for non-interventional observational studies conducted in Japan

Study type	Data source	Database example	Strengths	Limitations
Single-center study	Data stored at a single medical institution	-	Medical practice well-known Flexible approach	Limited volume of data [28]
Multi-center study	Medical records collected from collaborating medical institutions	-	Study team collaboration	Selection bias [29, 30] Medical practices can differ by institution [30]
Post-marketing surveillance study^a	Medical records collected from participating medical institutions	-	Data volume	Cost [31]
Study using a disease registry/database	Disease registry Disease database	All Japan Utstein Registry [22, 23] NinJa [24, 25] KCHF Registry [26, 27]	Disease-specific test results available Data volume	Selection bias [27]
Study using a dataset from a large-scale integrated database	Integrated large-scale database	JMDC Claim^b MDV Database^c NDB Japan^d MID-NET^e	Data volume	Careful interpretation of data is needed [31]

PMS Post-marketing surveillance, GPSP Good Post-marketing Study Practice, NinJa National Database of Rheumatic Diseases by iR-net (Divison of Rheumatology, Immunologic Disorder Network, National Hospital Organization) in Japan, KCHF Registry Kyoto Congestive Heart Failure Registry, JMDC Japan Medical Data Center, MDV Medical Data Vision, NDB Japan National Database of Health Insurance Claims and Specific Health Checkups of Japan, MID-NET Medical Information Database Network
^aA PMS study is a kind of multi-center study initiated by a sponsor and conducted under GPSP regulations [14, 15]
^bJMDC Claim is provided by Japan Medical Data Center, Inc. [17]
^cMDV Database is provided by Medical Data Vision Co., Ltd. [18]
^dNDB Japan is provided by the Ministry of Health, Labour and Welfare of Japan [19, 20]
^eMID-NET is sponsored by the Pharmaceuticals and Medical Devices Agency of Japan [21]

ISSN: 1472-6947