Principles for the use of large-scale medical databases to generate real-world evidence

Kumamaru, Hiraku; Fukuma, Shingo; Matsui, Hiroki; Kawasaki, Ryo; Tokumasu, Hironobu; Takahashi, Arata; Hara, Seigo; Aoki, Kotonari; Fujita, Takanori; Matsubara, Hiroaki

doi:10.37737/ace.2.1_27

Cited by 4 publications

(2 citation statements)

References 35 publications

(33 reference statements)

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“…We considered that the HETE studies were conducted largely in the DPC Study Group database because it is relatively easy to collect information about underlying diseases and severity of illnesses, as well as treatments or procedures using the DPC format 1 [ 1 , 13 ]. The DPC format 1 includes clinical data scores such as levels of consciousness (Japan Coma Scale), dementia severity, pneumonia severity, and other clinical scores.…”

Section: Discussionmentioning

confidence: 99%

“…The development of large-scale medical databases using real-world data (RWD) in Japan has led to the development of real-world evidence, and numerous studies have been published [ 1 ]. The US Food and Drug Administration defines RWD as patient health status and/or the delivery of healthcare data collected routinely from electronic health records, claims and billing activities, products, and disease registries, excluding the context of conventional randomized controlled trials [ 2 ].…”

Section: Introductionmentioning

confidence: 99%

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A Review of Research Studies Using Data from the Administrative Claims Databases in Japan

Fujinaga

Fukuoka

2022

Drugs - Real World Outcomes

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Background In Japan, several research studies have used administrative claims databases. However, no study has compared the studies conducted in each database. Objective We assessed the type, design, and research area of each research study using the administrative databases in Japan to illustrate the suitability of the database used for the types of research studies. Methods We reviewed studies from four administrative claims databases (the Japanese National Database of Health Insurance Claims and Specific Health Checkups [NDB]; the DPC Study Group database [DPC]; Japan Medical Data Center [JMDC]; and Medical Data Vision [MDV]). The PubMed database was searched from January 2015 to October 2020. We assessed the type, design, and research area of the abstract or full text of each research study. Results Overall, 643 studies were included. The number of studies increased from 59 in 2015 to 171 in 2020. Descriptive studies accounted for 62.7% (42 studies) of the studies from the NDB, while the treatment effectiveness studies accounted for 81.7% (211 studies) of the studies from the DPC database and were the most common in the JMDC and MDV. Cohort studies accounted for only 17.9% of the studies on NDB but 45.5% on DPC. The most common research area was medicine, general, and internal medicine (53 studies, 8.4%). Conclusions The type and design of the studies conducted differed in each database and were influenced by the characteristics of the database used. In the future, it may be necessary to integrate various real-world data databases to increase their comprehensiveness. Supplementary Information The online version contains supplementary material available at 10.1007/s40801-022-00331-5.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

A Review of Research Studies Using Data from the Administrative Claims Databases in Japan

Fujinaga

Fukuoka

2022

Drugs - Real World Outcomes

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Real-world impact of dupilumab on asthma disease burden in Japan: The CROSSROAD study

Fukunaga¹,

Tagaya²,

Ebisawa³

et al. 2023

Allergology International

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The Current Status of Secondary Use of Claims, Electronic Medical Records, and Electronic Health Records in Epidemiology in Japan: Narrative Literature Review

Zhao¹,

Tsubota²

2023

JMIR Med Inform

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Background Real-world data, such as claims, electronic medical records (EMRs), and electronic health records (EHRs), are increasingly being used in clinical epidemiology. Understanding the current status of existing approaches can help in designing high-quality epidemiological studies. Objective We conducted a comprehensive narrative literature review to clarify the secondary use of claims, EMRs, and EHRs in clinical epidemiology in Japan. Methods We searched peer-reviewed publications in PubMed from January 1, 2006, to June 30, 2021 (the date of search), which met the following 3 inclusion criteria: involvement of claims, EMRs, EHRs, or medical receipt data; mention of Japan; and published from January 1, 2006, to June 30, 2021. Eligible articles that met any of the following 6 exclusion criteria were filtered: review articles; non–disease-related articles; articles in which the Japanese population is not the sample; articles without claims, EMRs, or EHRs; full text not available; and articles without statistical analysis. Investigations of the titles, abstracts, and full texts of eligible articles were conducted automatically or manually, from which 7 categories of key information were collected. The information included organization, study design, real-world data type, database, disease, outcome, and statistical method. Results A total of 620 eligible articles were identified for this narrative literature review. The results of the 7 categories suggested that most of the studies were conducted by academic institutes (n=429); the cohort study was the primary design that longitudinally measured outcomes of proper patients (n=533); 594 studies used claims data; the use of databases was concentrated in well-known commercial and public databases; infections (n=105), cardiovascular diseases (n=100), neoplasms (n=78), and nutritional and metabolic diseases (n=75) were the most studied diseases; most studies have focused on measuring treatment patterns (n=218), physiological or clinical characteristics (n=184), and mortality (n=137); and multivariate models were commonly used (n=414). Most (375/414, 90.6%) of these multivariate modeling studies were performed for confounder adjustment. Logistic regression was the first choice for assessing many of the outcomes, with the exception of hospitalization or hospital stay and resource use or costs, for both of which linear regression was commonly used. Conclusions This literature review provides a good understanding of the current status and trends in the use of claims, EMRs, and EHRs data in clinical epidemiology in Japan. The results demonstrated appropriate statistical methods regarding different outcomes, Japan-specific trends of disease areas, and the lack of use of artificial intelligence techniques in existing studies. In the future, a more precise comparison of relevant domestic research with worldwide research will be conducted to clarify the Japan-specific status and challenges.

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Principles for the use of large-scale medical databases to generate real-world evidence

Cited by 4 publications

References 35 publications

A Review of Research Studies Using Data from the Administrative Claims Databases in Japan

A Review of Research Studies Using Data from the Administrative Claims Databases in Japan

Real-world impact of dupilumab on asthma disease burden in Japan: The CROSSROAD study

The Current Status of Secondary Use of Claims, Electronic Medical Records, and Electronic Health Records in Epidemiology in Japan: Narrative Literature Review

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