Observational studyBMC medical informatics and decision making2021
Characterization and selection of Japanese electronic health record databases used as data sources for non-interventional observational studies.
Observational study in BMC medical informatics and decision making, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
7 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Electronic medicine management systems in developing countries: A landscape review.British journal of clinical pharmacology · 2025Pooled it
- Clinical Disease Burden in Patients with Chronic Obstructive Pulmonary Disease and Type 2 Inflammation in Japan: A Retrospective Database Analysis (EUROS Study).International journal of chronic obstructive pulmonary disease · 2026Article
- Public Attitudes and Predictors of Public Awareness of Personal Digital Health Data Sharing for Research: Cross-Sectional Study in Japan.JMIR human factors · 2025Article
- Strategies to Address Current Challenges in Real-World Evidence Generation in Japan.Drugs - real world outcomes · 2023Review
- The Current Status of Secondary Use of Claims, Electronic Medical Records, and Electronic Health Records in Epidemiology in Japan: Narrative Literature Review.JMIR medical informatics · 2023Review
- History of Respiratory Events Prior to a First COPD Diagnosis and Future Exacerbations: A Longitudinal Observational Cohort Database Study in Japan.International journal of chronic obstructive pulmonary disease · 2023Observational
- Context and Considerations for Use of Two Japanese Real-World Databases in Japan: Medical Data Vision and Japanese Medical Data Center.Drugs - real world outcomes · 2022Review
Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundInterventional studies are the fundamental method for obtaining answers to clinical questions. However, these studies are sometimes difficult to conduct because of insufficient financial or human resources or the rarity of the disease in question. One means of addressing these issues is to conduct a non-interventional observational study using electronic health record (EHR) databases as the data source, although how best to evaluate the suitability of an EHR database when planning a study remains to be clarified. The aim of the present study is to identify and characterize the data sources that have been used for conducting non-interventional observational studies in Japan and propose a flow diagram to help researchers determine the most appropriate EHR database for their study goals.
methodsWe compiled a list of published articles reporting observational studies conducted in Japan by searching PubMed for relevant articles published in the last 3 years and by searching database providers' publication lists related to studies using their databases. For each article, we reviewed the abstract and/or full text to obtain information about data source, target disease or therapeutic area, number of patients, and study design (prospective or retrospective). We then characterized the identified EHR databases.
resultsIn Japan, non-interventional observational studies have been mostly conducted using data stored locally at individual medical institutions (663/1511) or collected from several collaborating medical institutions (315/1511). Whereas the studies conducted with large-scale integrated databases (330/1511) were mostly retrospective (73.6%), 27.5% of the single-center studies, 47.6% of the multi-center studies, and 73.7% of the post-marketing surveillance studies, identified in the present study, were conducted prospectively. We used our findings to develop an assessment flow diagram to assist researchers in evaluating and choosing the most suitable EHR database for their study goals.
conclusionsOur analysis revealed that the non-interventional observational studies were conducted using data stored local at individual medical institutions or collected from collaborating medical institutions in Japan. Disease registries, disease databases, and large-scale databases would enable researchers to conduct studies with large sample sizes to provide robust data from which strong inferences could be drawn.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.