Evidence map›Paper›PMID 39375184›Full record

ArticleBMJ open2024

Predicting mucosal inflammation in IBD patients using patient-reported symptom scores and a faecal calprotectin home test: protocol for a multicentre prospective validation study.

Laura Janssen, Reinier Cornelis Anthonius van Linschoten, Rachel Louise West, Lennard P L Gilissen, Mariëlle Romberg-Camps, Lloyd Brandts, Zlatan Mujagic, Tessa Eh Römkens, M Pierik

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05886322 (Comparison of Patient Reported Disease Activity Scores Combined With Fecal Calprotectin Home Tests for Remote Monitoring of IBD Patients), which is not on this 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.

NCT05886322 unknown statusnot on this map

Comparison of Patient Reported Disease Activity Scores Combined With Fecal Calprotectin Home Tests for Remote Monitoring of IBD Patients: a Multicenter Prospective Validation Study

TypeobservationalSponsorMaastricht University Medical CenterRan2022 to 2024Enrolled400ConditionsInflammatory Bowel Diseases, Crohn Disease, Ulcerative ColitisArmspatient reported outcome measures, fecal calprotectin, colonoscopy
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

9 authors.

Laura JanssenNUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, Limburg, Netherlands laura.janssen@maastrichtuniversity.nl.ORCID 0000-0002-0414-8665
Reinier Cornelis Anthonius van LinschotenGastroenterology and Hepatology, Franciscus Gasthuis en Vlietland, Rotterdam, Netherlands.ORCID 0000-0003-3052-596X
Rachel Louise WestDepartment of Gastroenterology & Hepatology, Franciscus Gasthuis, Rotterdam, Zuid-Holland, Netherlands.
Lennard P L GilissenDepartment of Gastroenterology, Catharina Hospital, Eindhoven, North Brabant, Netherlands.
Mariëlle Romberg-CampsGastroenterology, Zuyderland Medical Centre Sittard-Geleen, Sittard-Geleen, Limburg, Netherlands.
Lloyd BrandtsClinical Epidemiology and Medical Technology Assessment (KEMTA), Maastricht UMC+, Maastricht, Limburg, Netherlands.ORCID 0000-0002-0620-1271
Zlatan MujagicNUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, Limburg, Netherlands.
Tessa Eh RömkensDepartment of Gastroenteroloy and Hepatology, Jeroen Bosch Hospital, 's-Hertogenbosch, Noord-Brabant, Netherlands.
M PierikNUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, Limburg, Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionCrohn's disease and ulcerative colitis are chronic inflammatory bowel diseases (IBD) with a relapsing-remitting nature. With adequate non-invasive prediction of mucosal inflammation, endoscopies can be prevented and treatment optimised earlier for better disease control. We aim to validate and recalibrate commonly used patient-reported symptom scores combined with a faecal calprotectin (FC) home test as non-invasive diagnostic tool for remote monitoring of IBD, both in daily practice and in a strict trial setting. Endoscopy will be used as the gold standard. METHODS AND ANALYSIS: In this multicentre prospective validation study, adult IBD patients are asked to fill out questionnaires regarding disease activity (Monitor IBD At Home, mobile Health Index, Manitoba IBD Index, IBD control and patient-HBI/patient-Simple Clinical Colitis Activity Index), perform a FC home test and collect a stool sample for routine laboratory FC measurement, before the start of the bowel preparation for the ileocolonoscopy. Endoscopic disease activity will be scored according to the simplified endoscopic score for Crohn's disease (CD) for CD patients or Ulcerative Colitis Endoscopic Index for Severity and Mayo Endoscopic Subscore for ulcerative colitis patients. The main study outcome is the diagnostic test accuracy of the various patient-reported scores to assess mucosal inflammation in combination with a FC home test. ETHICS AND DISSEMINATION: This study is approved by the Medical Research Ethics Committee of azM/UM in Maastricht dated 03 March 2021 (METC 20-085) and is monitored by the Clinical Trial Centre Maastricht according to Good Clinical Practice guidelines. Written informed consent will be obtained from all patients. Study results will be published in international peer-reviewed medical journals. TRIAL REGISTRATION NUMBER: NCT05886322.

Indexed as

FecesLeukocyte L1 Antigen ComplexPatient Reported Outcome MeasuresAdultBiomarkersColitis, UlcerativeColonoscopyCrohn DiseaseHumansInflammatory Bowel DiseasesIntestinal MucosaMulticenter Studies as TopicProspective StudiesSeverity of Illness IndexSurveys and QuestionnairesValidation Studies as TopicBiomarkersLeukocyte L1 Antigen ComplexAdult gastroenterologyEndoscopyInflammatory bowel diseasePatient-reported outcome measuresStatistics and research methods

Identifiers

PMID39375184
PMCPMC11459379

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Registered trials

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.