Evidence map›Paper›PMID 35362902›Full record

ArticleJournal of patient-reported outcomes2022

Incorporating patient experience into drug development for ulcerative colitis: development of the Urgency Numeric Rating Scale, a patient-reported outcome measure to assess bowel urgency in adults.

Marla C Dubinsky, Peter M Irving, Remo Panaccione, April N Naegeli, Alison Potts-Bleakman, Vipin Arora, Mingyang Shan, Simon Travis

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Journal of patient-reported outcomes, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 53 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 1 pooled it
10.7field-weighted citation impact, top 1% 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.

NCT06864403 phase4recruitingnot on this mapstarted 2025, after this paper: background citation

Mirikizumab in the Treatment of Chronic Inflammatory Conditions of the Pouch

TypeinterventionalSponsorUniversity of North Carolina, Chapel HillRan2025 to 2027Enrolled25ConditionsPouchitis, Pouches, Ileoanal, Pouch, IlealArmsMirikizumab - Intravenous (IV), Mirikizumab - Subcutaneous (SC)
NCT07756359 phase4not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Efficacy of the Dual GIP - GLP-1 Receptor Agonist Tirzepatide in Patients With an Ileal Pouch-anal Anastomosis (IPAA) and Chronic High Bowel Frequency (I8F-NS-X008)

TypeinterventionalSponsorUniversity of North Carolina, Chapel HillRan2026 to 2027Enrolled20ConditionsPouch, Ileal, Pouches, Ileoanal, Bowel Diseases, InflammatoryArmsTirzepatide, Loperamide, Diphenoxylate/Atropine
3 · Its place in the literature

Who cites it

53 citing papers in PubMed, 1 synthesis or guideline pooled it, 64 citations in OpenAlex.

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  15. Response to meeting STRIDE-II targets in routine practice: Assessment, access, and service design.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2026
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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

8 authors at 5 institutions in 3 countries.

Marla C DubinskyDepartment of Pediatrics, Susan and Leonard Feinstein IBD Center, Icahn School of Medicine, Mount Sinai, 17 East 102nd Street, 5th Floor East, New York, NY, 10029, USA. marla.dubinsky@mssm.edu.ORCID http://orcid.org/0000-0003-4968-5795
Peter M IrvingDepartment of Gastroenterology, Guy's and St Thomas' NHS Foundation Trust, London, UK.
Remo PanaccioneInflammatory Bowel Disease Unit, University of Calgary, Calgary, AB, Canada.
April N NaegeliEli Lilly and Company, Indianapolis, IN, USA.
Alison Potts-BleakmanEli Lilly and Company, Indianapolis, IN, USA.
Vipin AroraEli Lilly and Company, Indianapolis, IN, USA.
Mingyang ShanEli Lilly and Company, Indianapolis, IN, USA.
Simon TravisTranslational Gastroenterology Unit, Oxford University Hospitals NHS Foundation Trust and NIHR Biomedical Research Centre, Oxford, UK.
Eli Lilly (United States) · USGuy's and St Thomas' NHS Foundation Trust · GBIcahn School of Medicine at Mount Sinai · USUniversity of Calgary · CAUniversity of Oxford · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBowel urgency, the sudden or immediate need to have a bowel movement, is a common, bothersome and disruptive symptom of ulcerative colitis (UC). UC treatment goals include control of urgency; however, it is not consistently assessed in UC clinical trials. The Urgency Numeric Rating Scale (NRS) is a new patient-reported measure to assess severity of bowel urgency in adults with UC developed in accordance with Food and Drug Administration guidelines.

methodsQualitative interviews were used to develop Urgency NRS. The scale asks patients to report the immediacy status of their UC symptom over the past 24 h on an 11-point horizontal numeric rating scale [0 (No urgency) to 10 (Worst possible urgency)]. Higher scores indicate worse urgency severity. A 2-week diary study assessed floor and ceiling effects, test-retest reliability (intraclass correlation coefficient (ICC) (2,1) between Week 1 and 2), and construct validity (Spearman correlation using Week 1 scores). Weekly scores were calculated as mean score over each 7-day period.

resultsQualitative interviews with 16 UC patients (mean age 37.9 ± 11.6 years; 50% female; 56% White) confirmed relevance, content, and comprehensiveness. The 2-week diary study included 41 UC patients (mean age 44.2 ± 14.6 years; 51% female; 56% White). No ceiling or floor effects were identified. Test-retest reliability was high (ICC = 0.877). Average Urgency NRS and patient global rating of severity scores were highly correlated, with a moderate correlation between average Urgency NRS and stool frequency, demonstrating construct validity.

conclusionsBowel urgency is a distinct symptom of UC. The Urgency NRS is a well-defined, content-valid, and reliable measurement of bowel urgency in adults with UC.

Indexed as

Bowel urgencyNRSPatient-reported outcomePROUCUrgency

Identifiers

PMID35362902
PMCPMC8975984
OpenAlexW4220718642

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.