Evidence map›Paper›PMID 39034943›Full record

ArticleAnnals of clinical epidemiology2024

A Continuous Registry of Medical Record, Patient Input, and Epidemiological Data of Patients With Ulcerative Colitis: a Multicentre, Prospective, Observational Clinical Registry Study in Japan.

Katsuyoshi Matsuoka, Shuji Hibiya, Katsuyoshi Ando, Yuji Tani, Takehiro Torisu, Haruei Ogino, Takanori Yamashita, Akira Andoh, Yoshihisa Sugimoto, Takayuki Matsumoto and 3 more

Abstract read
In one paragraph

Article in Annals of clinical epidemiology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

13 authors.

Katsuyoshi MatsuokaDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Toho University Sakura Medical Center.
Shuji HibiyaDepartment of Gastroenterology and Hepatology, Tokyo Medical and Dental University.
Katsuyoshi AndoGastroenterology and Endoscopy, Division of Metabolism and Biosystemic Science, Gastroenterology, and Hematology/Oncology, Department of Medicine, Asahikawa Medical University.
Yuji TaniDepartment of Medical Informatics and Hospital Management, Asahikawa Medical University.
Takehiro TorisuDepartment of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University.
Haruei OginoDepartment of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University.
Takanori YamashitaMedical Information Center, Kyushu University Hospital.
Akira AndohDepartment of Medicine, Shiga University of Medical Science.
Yoshihisa SugimotoDepartment of Medical Informatics and Biomedical Engineering, Shiga University of Medical Science.
Takayuki MatsumotoDivision of Gastroenterology and Hepatology, Department of Internal Medicine, School of Medicine, Iwate Medical University.
Yusuke IwanagaClinical Research Operation, Mebix, Inc.
Takashi SudaDepartment of information system, Kitasato University, Kitasato Institute Hospital.
Taku KobayashiCenter for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis 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.

methodsInclusion 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.

conclusionsThe 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.

Indexed as

JapanRegistry studyStudy protocolUlcerative colitis

Identifiers

PMID39034943
PMCPMC11254582

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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.