BACKGROUND

Delayed vaccination is a well-studied and critical public health issue. However, limited studies have explored whether familial factors influence vaccination delay. This study aimed to determine whether family structure and comorbidities affect the refusal or delayed receipt of measles-rubella and varicella vaccines.

METHODS

We gathered data on all children from birth to 13 months of age between 2006 and 2020 using vaccination records linked with the administrative healthcare claims data from a Japanese city. Multivariable logistic regression analyses were conducted to examine the association of refusal or delay in receiving the first-dose measles-rubella and varicella vaccines with the following factors: the child’s sex; presence of parents, siblings, and grandparents; parental and grandparental comorbidities; chronic pediatric comorbidities in the child and siblings; and year of vaccination.

RESULTS

We identified a total of 14,241 eligible children. Refusal or delayed receipt of the first-dose measles-rubella vaccine was associated with an adjusted odds ratio of 2.46 (95% confidence interval, 1.86–3.24) for maternal absence and 1.61 (1.44–1.80) for paternal absence. Similarly, the refusal or delay in receiving the first-dose varicella vaccine was associated with an adjusted odds ratio of 2.04 (95% confidence interval, 1.01–4.16) for maternal absence and 1.37 (1.12–1.69) for paternal absence. The presence of siblings and maternal comorbidities were significantly associated with vaccination delays.

CONCLUSION

The absence of a parent, the presence of siblings, and maternal comorbidities were associated with the refusal or delay in receiving measles-rubella and varicella vaccines. Strategies for vaccine recommendation should therefore consider family structure and maternal comorbidities.

Background

This article aims to introduce the Real World Database—a new clinical database in Japan.

Methods

The Health, Clinic, and Education Information Evaluation Institute and Real World Data Co., Ltd. began developing the Real World Database in 2015. This is an electronic medical record database linked to claims data and discharge abstract data from medical institutions in Japan. The institutions agreed to collect data from 218 medical institutions as of June 2021.

Results

In 2019, 82 medical institutions provided data, which showed that 2,184,666 patients received treatment at medical institutions. There were also 334,437 inpatients with at least one hospital stay and 2,011,628 outpatients with at least one visit. More than 200 laboratory test results were available.

Discussion

This database is a potential data source for producing descriptive studies, comparative effectiveness studies, studies of adverse effects, and prediction studies.

Conclusions

The Real World Database provides an opportunity and strategy to produce real-world evidence for Japan.

BACKGROUND

This registry aims to allow for a prospective non-interventional observational study of ulcerative colitis. This will facilitate monitoring of the current state of ulcerative colitis in Japan and improving the long-term disease course and adverse events associated with current treatment options.

METHODS

Inclusion of patients from five centres in Japan is planned. The study is expected to take place from July 15, 2020, to November 30, 2024. Background, demographics, and medical history/information will be collected from electronic medical records at enrolment. Medical information including medications, laboratory data, and disease activity will be collected automatically from electronic medical records throughout the study. Patient-reported quality of life data will be collected directly from patients via smartphone. Efficacy endpoints (clinical remission rate, clinical improvement rate, and endoscopic healing rate) and safety endpoints (incidence of adverse events and specific ulcerative colitis-related events) will be collected according to treatment administered. Treatment categories include no treatment, 5-aminosalicylic acids, corticosteroids, immunomodulators, immunosuppressants, anti-tumour necrosis alpha agents, cytapheresis, Janus kinase inhibitors, anti-integrin antibodies, and anti-interleukin-12/23 antibodies.

CONCLUSIONS

The dataset will include cross-sectional and longitudinal data and is expected to capture the state of ulcerative colitis in Japan. Patients will be included on a large scale, and the registry will be established automatically from electronic medical records and direct patient input, facilitating the accurate recording of medical information for patients with ulcerative colitis in Japan and minimizing limitations intrinsic to databases that require manual data entry, such as the burden on participating investigators and entry of data with errors/typos.

The Ministry of Health, Labour, and Welfare, Japan launched a national administrative claims database in 2009, which is called the National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB). Detailed information on the NDB was reported in Annals of Clinical Epidemiology in 2019. The present report provides updated information on the NDB. In 2020, the provision of data to private companies, as well as public sectors and academic entities, was legislated. As of 2024, the Ministry of Health, Labour, and Welfare is planning linkage of NDB data with several other national databases. Our previous literature review identified a total of 126 original articles using the NDB and NDB Open Data published from 2013 to 2022. Our updated review identified 94 original articles using the NDB and NDB Open Data in the recent two years. Studies using the NDB are gradually increasing, but there is still room for enhancing NDB studies on various subject areas.