Evidence map›Paper›PMID 35290407›Full record

ArticlePloS one2022

Validation of an online application to identify potential immune-related adverse events associated with immune checkpoint inhibitors based on the patient's symptoms.

Takahiro Osawa, Takashige Abe, Hiroshi Kikuchi, Ryuji Matsumoto, Sachiyo Murai, Takafumi Nakao, Shinji Tanaka, Ayu Watanabe, Nobuo Shinohara

Open access · goldAbstract read
In one paragraph

Article in PloS one, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 48% of its field
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

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Review
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

9 authors at 2 institutions in 1 country.

Takahiro OsawaDepartment of Urology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.ORCID 0000-0003-4444-7958
Takashige AbeDepartment of Urology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.
Hiroshi KikuchiDepartment of Urology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.
Ryuji MatsumotoDepartment of Urology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.
Sachiyo MuraiDepartment of Urology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.
Takafumi NakaoPharmacovigilance Division, Ono Pharmaceutical Co., Ltd., Osaka, Japan.
Shinji TanakaPharmacovigilance Division, Ono Pharmaceutical Co., Ltd., Osaka, Japan.
Ayu WatanabePharmacovigilance Division, Ono Pharmaceutical Co., Ltd., Osaka, Japan.
Nobuo ShinoharaDepartment of Urology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.
Hokkaido University · JPOno Pharmaceutical (Japan) · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundImmune checkpoint inhibitors (ICIs) are increasingly being used to treat malignancies. Some patients experience immune-related adverse events (irAEs), which may affect any organ/tissue. IrAEs are occasionally fatal and usually have nonspecific symptoms. We developed a three-step application (https://irae-search.com/) to provide healthcare professionals with information on the diagnosis, treatment options, and published reports for 38 categories of irAEs encountered in clinical practice.

methodsIrAEs reported in ≥5 cases were identified from articles published between October 2018 and August 2020 by searching Japanese (SELIMIC, JAPIC-Q Service, and JMED Plus) and international (MEDLINE, EMBASE, Derwent Drug File) databases. The cases' symptoms were entered into the application to identify irAEs, which were verified using the reported diagnosis, to evaluate the application's sensitivity and specificity.

resultsOverall, 1209 cases (1067 reports) were analyzed. The three most common categories of irAEs were pituitary or adrenal disorders (14% of cases), skin disorders (13%), and diabetes mellitus (10%). The top three primary diseases were lung cancer (364 cases), melanoma (286 cases), and renal cell carcinoma (218 cases). The average sensitivity was 90.8% (range 44.4%-100.0%) initially, and improved to 94.8% (range 83.3%-100.0%) after incorporating the symptoms reported in published cases into the application's logic for two irAE categories. The average specificity was 79.3% (range 59.1% [thyroid disorders]-98.2% [arthritis]).

conclusionirAE Search is an easy-to-use application designed to help healthcare professionals identify potential irAEs in ICI-treated patients in a timely manner to facilitate prompt management/treatment. The application showed high sensitivity and moderate-to-high specificity for detecting irAEs.

Indexed as

Carcinoma, Renal CellKidney NeoplasmsLung NeoplasmsDatabases, FactualFemaleHumansImmune Checkpoint InhibitorsMaleRetrospective StudiesImmune Checkpoint Inhibitors

Identifiers

PMID35290407
PMCPMC8923505
OpenAlexW4220906520

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

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.