Evidence map›Paper›PMID 36795060›Full record

ArticleJournal of Crohn's & colitis2023

Development and Validation of a Remote Monitoring Tool for Assessment of Mild, Moderate, and Severe Infections in Inflammatory Bowel Disease.

Ashkan Rezazadeh Ardabili, Dirk van Esser, Dion Wintjens, Mia Cilissen, Debbie Deben, Zlatan Mujagic, Fritzi Russ, Laurents Stassen, Adriaan A Van Bodegraven, Dennis Wong and 4 more

Open access · hybridAbstract read
In one paragraph

Article in Journal of Crohn's & colitis, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.6field-weighted citation impact, top 25% 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

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Observational
  2. 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

14 authors at 3 institutions in 2 countries.

Ashkan Rezazadeh ArdabiliDepartment of Internal Medicine, Division of Gastroenterology and Hepatology, Maastricht University Medical Centre+, Maastricht, The Netherlands.ORCID 0000-0002-5082-605X
Dirk van EsserDepartment of Internal Medicine, Division of Gastroenterology and Hepatology, Maastricht University Medical Centre+, Maastricht, The Netherlands.
Dion WintjensDepartment of Internal Medicine, Division of Gastroenterology and Hepatology, Maastricht University Medical Centre+, Maastricht, The Netherlands.
Mia CilissenDepartment of Internal Medicine, Division of Gastroenterology and Hepatology, Maastricht University Medical Centre+, Maastricht, The Netherlands.
Debbie DebenDepartment of Clinical Pharmacy, Clinical Pharmacology and Toxicology, Zuyderland Medical Centre, Sittard-Geleen, The Netherlands.
Zlatan MujagicDepartment of Internal Medicine, Division of Gastroenterology and Hepatology, Maastricht University Medical Centre+, Maastricht, The Netherlands.
Fritzi RussDepartment of Gastroenterology, Geriatrics, Internal and Intensive Care Medicine, Zuyderland Medical Centre, Sittard-Geleen, The Netherlands.
Laurents StassenSchool for Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre+, Maastricht, The Netherlands.
Adriaan A Van BodegravenDepartment of Gastroenterology, Geriatrics, Internal and Intensive Care Medicine, Zuyderland Medical Centre, Sittard-Geleen, The Netherlands.
Dennis WongDepartment of Clinical Pharmacy, Clinical Pharmacology and Toxicology, Zuyderland Medical Centre, Sittard-Geleen, The Netherlands.
Bjorn WinkensDepartment of Methodology and Statistics, Care and Public Health Research Institute,, Maastricht University, Maastricht, The Netherlands.
Daisy JonkersDepartment of Internal Medicine, Division of Gastroenterology and Hepatology, Maastricht University Medical Centre+, Maastricht, The Netherlands.
Mariëlle Romberg-CampsDepartment of Gastroenterology, Geriatrics, Internal and Intensive Care Medicine, Zuyderland Medical Centre, Sittard-Geleen, The Netherlands.
Marie J PierikDepartment of Internal Medicine, Division of Gastroenterology and Hepatology, Maastricht University Medical Centre+, Maastricht, The Netherlands.ORCID 0000-0001-6981-6516
Maastricht University Medical Centre · NLZuyderland Medisch Centrum · NLMaastricht University · NL

Funding

Takeda IISR-2019-102915
6 · The paper itself

Abstract

backgroundImmunomodulators and biologics are cornerstones in the management of inflammatory bowel disease [IBD], but are associated with increased risk of infections. Post-marketing surveillance registries are pivotal to assess this risk, yet mainly focus on severe infections. Data on the prevalence of mild and moderate infections are scarce. We developed and validated a remote monitoring tool for real-world assessment of infections in IBD patients.

methodsA 7-item Patient-Reported Infections Questionnaire [PRIQ] covering 15 infection categories was developed with a 3-month recall period. Infection severity was defined as mild [self-limiting or topical treatment], moderate [oral antibiotics, antivirals, or antifungals], or severe [hospitalisation or intravenous treatment]. Comprehensiveness and comprehensibility were ascertained through cognitive interviewing of 36 IBD outpatients. After implementation in the telemedicine platform myIBDcoach, a prospective, multicentre cohort study was performed between June 2020 and June 2021 in 584 patients, to assess diagnostic accuracy. Events were cross-checked with general practitioner and pharmacy data [gold standard]. Agreement was evaluated using linear-weighted kappa with cluster-bootstrapping to account for within-patient level correlation.

resultsPatient understanding was good and interviews did not result in reduction of PRIQ items. During validation, 584 IBD patients {57.8% female, mean age 48.6 (standard deviaton [SD]: 14.8), disease duration 12.6 years [SD: 10.9]} completed 1386 periodic assessments, reporting 1626 events. Linear-weighted kappa for agreement between PRIQ and gold standard was 0.92 (95% confidence interval [CI] 0.89-0.94). Sensitivity and specificity for infection [yes/no] were 93.9% [95% CI 91.8-96.0] and 98.5% [95% CI 97.5-99.4], respectively.

conclusionsThe PRIQ is a valid and accurate remote monitoring tool to assess infections in IBD patients, providing means to personalise medicine based on adequate benefit-risk assessments.

Indexed as

Inflammatory Bowel DiseasesCohort StudiesFemaleHumansMaleMiddle AgedProspective StudiesSurveys and QuestionnairesdevelopmentIBDinfectionsreal-world dataRemote monitoring toolvalidation

Identifiers

PMID36795060
PMCPMC10320484
OpenAlexW4321003538

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.