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. 2022 Apr 1;6(1):31.
doi: 10.1186/s41687-022-00439-w.

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  1 , Peter M Irving  2 , Remo Panaccione  3 , April N Naegeli  4 , Alison Potts-Bleakman  4 , Vipin Arora  4 , Mingyang Shan  4 , Simon Travis  5
Affiliations

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 et al. J Patient Rep Outcomes. .

Abstract

Background: Bowel 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.

Methods: Qualitative 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.

Results: Qualitative 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.

Conclusions: Bowel 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.

Keywords: Bowel urgency; NRS; PRO; Patient-reported outcome; UC; Urgency.

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Conflict of interest statement

MCD has received consultant fees or research support from Janssen, AbbVie, Roche, UCB, Pfizer, Takeda, Arena, Prometheus, Celgene, Lilly. PMI has received honoraria for acting in an advisory capacity from AbbVie, Celgene, Genentech, Gilead, Hospira, Janssen, Lilly, MSD, Pfizer, Pharmacosmos, Prometheus, Samsung Bioepis, Sandoz, Takeda, Topivert, VH2, Vifor, and Warner Chilcott; received speaker fees from AbbVie, Falk Pharma, Ferring, Janssen, MSD, Pfizer, Sandoz, Shire, Takeda, Tillotts, and Warner Chilcott; and received research funding from MSD, Pfizer, and Takeda. RP has received consultant and/or lecture fees from AbbVie, Amgen, AstraZeneca, Axcan Pharma (now Aptalis), Biogen Idec, Bristol Myers Squibb, Centocor, ChemoCentryx, Eisai Medical Research Inc., Elan Pharmaceuticals, Ferring, Genentech, GlaxoSmithKline, Janssen, Merck Sharp & Dohme, Millennium Pharmaceuticals (now Takeda Oncology), Ocera Therapeutics Inc., Otsuka America Pharmaceutical, Pfizer, Shire Pharmaceuticals, Prometheus Laboratories, Schering-Plough Corporation, Synta Pharmaceuticals Corp., Teva, UCB Pharma, and Warner Chilcott. ANN, APB, VA, and MS are employees and stockholders at Eli Lilly and Company. ST has received grants/research support from AbbVie, Buhlmann, Celgene, International Organization for the study of Inflammatory Bowel Diseases, Janssen, Lilly, Takeda, UCB, Vifor, and Norman Collisson Foundation; has received consulting fees from Abacus, AbbVie, Actial, ai4gi, Alcimed, Allergan, Amgen, Arena, Asahi, Astellas, Atlantic, AstraZeneca, Barco, Biocare, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Buhlmann, Calcico, Celgene, Celsius, Cellerix, Cerimon, ChemoCentryx, Cisbio, Coronado, Cosmo, Ducentis, Dynavax, Elan, Enterome, Falk, Ferring, FPRT Bio, Giuliani SpA, Genentech, Genzyme, Glenmark, Grunenthal, GlaxoSmithKline, GW Pharmaceuticals, Immunocore, Immunometabolism, Indigo, Janssen, Lexicon, Lilly, Medarex, Merck, MSD, Netbiotix, Neovacs, Novartis, Novo Nordisk, NPS Pharmaceuticals, Ocera, Ptima, Otsuka, Palau, Pentax, Pfizer, Philips, Procter & Gamble, Pronota, Proximagen, Resolute, Receptos, Robarts, Roche, Sandoz, Santarus, Sensyne, Shire, Sigmoid Pharma, SynDermix, Synthon, Takeda, Theravance, TiGenix, Tillotts, Topivert, TxCell, UCB, Vertex, VHsquared, Vifor, Warner Chilcott, and Zeria; and has received speaker fees from AbbVie, Amgen, Biogen, Falk, Ferring, GlaxoSmithKline, Janssen, Shire, Takeda, and Zeria.

Figures

Fig. 1
Fig. 1
Urgency NRS, a patient-reported outcome measure to assess bowel urgency in adults with ulcerative colitis. For permission to reproduce or use Urgency NRS, please contact copyright@lilly.com
Fig. 2
Fig. 2
Item distribution and floor/ceiling effects for Urgency NRS scores by day of 2-week diary study
See this image and copyright information in PMC

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