Evidence map›Paper›PMID 40145462›Full record

ArticleNeurogastroenterology and motility2025

Intra- and Interobserver Variability of Acute Food-Induced Reactions During Confocal Laser Endomicroscopy: An International Multicenter Validation Study.

Lukas Michaja Balsiger, Tom van Gils, Yaser Hatem, Amanda Blomsten, Karlien Raymenants, Cedric Van de Bruaene, Leila Juvyns, Johann P Hreinsson, Tim Vanuytsel, Hans Törnblom and 3 more

Abstract readMulticenter StudyValidation Study
In one paragraph

Article in Neurogastroenterology and motility, 2025. 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
–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

1 citing paper in PubMed.

  1. Article
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.

Lukas Michaja BalsigerTranslational Research Center for Gastrointestinal Disorders, KU Leuven, Leuven, Belgium.ORCID https://orcid.org/0000-0001-7399-8500
Tom van GilsDepartment of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Yaser HatemUniversity of Luebeck Institute of Nutritional Medicine, University Hospital of Schleswig-Holstein, Campus Lübeck and University of Lübeck, Lübeck, Germany.
Amanda BlomstenDepartment of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Karlien RaymenantsTranslational Research Center for Gastrointestinal Disorders, KU Leuven, Leuven, Belgium.ORCID https://orcid.org/0000-0003-0520-4734
Cedric Van de BruaeneTranslational Research Center for Gastrointestinal Disorders, KU Leuven, Leuven, Belgium.
Leila JuvynsTranslational Research Center for Gastrointestinal Disorders, KU Leuven, Leuven, Belgium.
Johann P HreinssonDepartment of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.ORCID https://orcid.org/0000-0002-0078-3063
Tim VanuytselTranslational Research Center for Gastrointestinal Disorders, KU Leuven, Leuven, Belgium.ORCID https://orcid.org/0000-0001-8728-0903
Hans TörnblomDepartment of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.ORCID https://orcid.org/0000-0003-2117-9874
Christian SinaUniversity of Luebeck Institute of Nutritional Medicine, University Hospital of Schleswig-Holstein, Campus Lübeck and University of Lübeck, Lübeck, Germany.
Magnus SimrenDepartment of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Jan TackTranslational Research Center for Gastrointestinal Disorders, KU Leuven, Leuven, Belgium.

Funding

Bundesministerium für Bildung und ForschungFonds Wetenschappelijk OnderzoekNovartis Stiftung für Medizinisch-Biologische ForschungSchweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung
6 · The paper itself

Abstract

BACKGROUND AND STUDY

aimsProbe-based confocal laser endomicroscopy (pCLE) enables real-time microscopic visualization of the duodenal mucosa and has shown acute food-triggered disruption of the duodenal epithelial barrier of patients with irritable bowel syndrome (IBS). The interpretation of the recordings is subjective, with unknown agreement rates. The aim of this study was to investigate the intra- and interobserver variability of this technique. PATIENTS AND

methodsAn international multicenter study was performed, including pCLE recordings from three centers. Recordings were randomized and re-evaluated by five blinded experienced assessors. Low-quality recordings were excluded. The mucosa was considered altered if both fluorescein leakage and luminal particles were observed. Agreement was quantified using Fleiss' and Cohen's kappa (κ). Reference videos (i.e., videos with 100% agreement) were used to assess the optimal characteristics of videos needed to make a judgment based on the optimal receiver operating characteristic curve cutoff.

resultsOf the 119 individual recordings, 87 could be used for analyses (total of 86,408 frames). Intraindividual agreement rate was 80%-100%, whereas the interindividual agreement rate was 85% (κ = 0.68). The agreement rate with the endoscopist ranged 54%-95% (κ = 0.15-0.89). The optimal cutoff to distinguish altered from unaltered was by observing alterations in ≥ 2 out of 6 mucosal spots (100% sensitivity and specificity).

conclusionOur study showed a substantial to perfect intraobserver agreement and a substantial interobserver agreement for the judgment of acute food-triggered disruption of the duodenal epithelial barrier by pCLE, confirming that this real-time readout is reliable and reproducible.

Indexed as

DuodenumFoodIntestinal MucosaIrritable Bowel SyndromeAdultFemaleHumansMaleMicroscopy, ConfocalMiddle AgedObserver Variationatypical food allergiesCLEconfocal laser endomicroscopyIBSirritable bowel syndrome

Identifiers

PMID40145462
PMCPMC12163209

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Registered trials

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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.