Evidence map›Paper›PMID 39692838›Full record

Trial reportAdvances in therapy2025

The Urgency Numeric Rating Scale: Psychometric Evaluation in Adults with Crohn's Disease.

Marla Dubinsky, Aisha Vadhariya, Sylvia Su, Xian Zhou, Frederick Durand, Claudine Clucas, Larissa Stassek, Ariane K Kawata, Simon Travis

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Advances in therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03926130 (A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active- Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Crohn's Disease), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT03926130 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active- Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Crohn's Disease

TypeinterventionalSponsorEli Lilly and CompanyRan2019 to 2023Enrolled1,158ConditionsCrohn's DiseaseArmsMirikizumab, Ustekinumab, Placebo
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. 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.

Marla DubinskyDr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Aisha VadhariyaEli Lilly and Company, 893 S Delaware St., Indianapolis, IN, 46225, USA. vadhariya_aisha@lilly.com.ORCID 0000-0002-1811-5370
Sylvia SuEli Lilly and Company, 893 S Delaware St., Indianapolis, IN, 46225, USA.
Xian ZhouSyneos Health, Morrisville, NC, USA.
Frederick DurandEli Lilly and Company, 893 S Delaware St., Indianapolis, IN, 46225, USA.
Claudine ClucasEvidera, London, UK.
Larissa StassekEvidera, Wilmington, NC, USA.
Ariane K KawataEvidera, Wilmington, NC, USA.
Simon TravisKennedy Institute, Translational Gastroenterology Unit and Biomedical Research Centre, University of Oxford, Oxford, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionBowel urgency has recently been recognized as a Crohn's disease (CD) symptom that substantially impacts patients' quality of life. The Urgency NRS is a single-item patient-reported outcome measure assessing bowel urgency severity in the past 24 h (0-10 scale). We aimed to evaluate the psychometric properties of the Urgency Numeric Rating Scale (NRS) in adults with moderately to severely active CD and to estimate thresholds for meaningful improvement and bowel urgency remission.

methodsPsychometric analyses used pooled data from the Phase 3 VIVID-1 study of mirikizumab, where participants with CD completed the Urgency NRS and other assessments. The Patient Global Rating of Severity (PGRS) and Patient Global Impression of Change (PGIC) were used as primary anchors to estimate Urgency NRS thresholds representing meaningful improvement and remission.

resultsThe Urgency NRS showed good test-retest reliability in participants who were stable based on PGRS and PGIC. It was moderately correlated with similar assessments and weakly correlated with endoscopic/laboratory assessments. It differentiated between participant subgroups varying in disease severity and quality of life based on PGRS and other assessments. It was sensitive to change, as Urgency NRS improvements during the trial differed between most PGRS change and PGIC categories. A 3-5-point reduction on the Urgency NRS represented meaningful improvement and a score of ≤ 2 represented remission.

conclusionThe Urgency NRS demonstrated strong psychometric properties in the VIVID-1 population of moderately to severely active CD. Analyses also suggested meaningful improvement and remission thresholds.

trial registrationClinicaltrials.gov, NCT03926130. Registered 23 April 2019, https://clinicaltrials.gov/study/NCT03926130 .

Indexed as

Antibodies, Monoclonal, HumanizedCrohn DiseasePatient Reported Outcome MeasuresAdultFemaleHumansMaleMiddle AgedPsychometricsQuality of LifeReproducibility of ResultsSeverity of Illness IndexYoung AdultAntibodies, Monoclonal, HumanizedmirikizumabBowel urgencyCrohn’s diseasePsychometric evaluationUrgency Numeric Rating Scale

Identifiers

PMID39692838
PMCPMC11787167

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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.