Evidence map›Paper›PMID 34437567›Full record

ArticlePloS one2021

The background occurrence of selected clinical conditions prior to the start of an extensive national vaccination program in Japan.

Tomotaka Sobue, Haruhisa Fukuda, Tetsuya Matsumoto, Bennett Lee, Shuhei Ito, Satoshi Iwata

Abstract read
In one paragraph

Article in PloS one, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Article
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  5. Real-world evaluation of osteoporotic fractures using the Japan Medical Data Vision database.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2022
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Tomotaka SobueDivision of Environmental Medicine and Population Science, Graduate School of Medicine, Osaka University, Osaka, Japan.
Haruhisa FukudaDepartment of Health Care Administration and Management, Kyushu University, Fukuoka, Japan.
Tetsuya MatsumotoDepartment of Infectious Diseases, International University of Health and Welfare, Narita, Japan.
Bennett LeeVaccine Medical Affairs, Pfizer Japan Inc., Tokyo, Japan.
Shuhei ItoVaccine Medical Affairs, Pfizer Japan Inc., Tokyo, Japan.ORCID 0000-0003-0289-7766
Satoshi IwataDepartment of Infectious Diseases, National Cancer Center Hospital, Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe COVID-19 pandemic caused by SARS-CoV-2 has now affected tens of millions of people globally. It is the hope that vaccines against SARS-CoV-2 will deliver a comprehensive solution to this global pandemic; however, this will require extensive national vaccination programs. Ultimately, clinical conditions and even sudden unexplained death will occur around the time of vaccination, thus a distinction needs to be made between events that are causally related to the vaccine or temporally related to vaccination. This study aimed to estimate the background occurrence of 43 clinical conditions in the Japanese population.

methodsA retrospective cohort study was conducted from 2013 to 2019 using data from two large healthcare claims databases (MDV and JMDC) in Japan. The estimated number of new cases and incidence were calculated based on the actual number of new cases identified in the databases. The PubMed and Ichushi-web databases, as well as grey literature such as guidelines and government statistics, were also searched to identify any publications related to incidence of these conditions in Japan. RESULTS AND

conclusionThe estimates of the number of total cases and incidence were similar for the MDV and JMDC databases for some diseases. In addition, some estimates were similar to those in the scientific literature. For example, from the MDV and JMDC databases, estimates of incidence of confirmed Bell's palsy in 2019 were 41.7 and 47.9 cases per 100,000 population per year, respectively. These estimates were of the same order from the scientific publication. Determining whether clinical conditions occurring around the time of vaccination are causally or only temporally related to vaccination will be critical for public health decision makers as well as for the general public. Comparison of background occurrence at the population level may provide some additional objective evidence for the evaluation of temporality or causality.

Indexed as

Immunization ProgramsBell PalsyCOVID-19Databases, FactualGuillain-Barre SyndromeHumansJapanOptic NeuritisRetrospective StudiesSARS-CoV-2Vaccination

Identifiers

PMID34437567
PMCPMC8389412

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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.