Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
Quality of Life Research
Published in: Quality of Life Research 12/2023

Open Access 04-08-2023 | Crohn's Disease

Validation of the bowel urgency numeric rating scale in patients with Crohn’s disease: results from a mixed methods study

Authors: Marla C. Dubinsky, Laure Delbecque, Theresa Hunter, Gale Harding, Larissa Stassek, Richard E. Moses, James D. Lewis

Published in: Quality of Life Research | Issue 12/2023

Login to get access

Abstract

Purpose

Bowel urgency (BU) is an important symptom of Crohn’s disease (CD), however there is no patient-reported outcome (PRO) scale validated in this population to assess BU severity. Here we evaluated the content validity and psychometric properties of the Urgency Numeric Rating Scale (NRS).

Method

Qualitative interviews were conducted with moderate-to-severe CD participants to confirm importance and relevance of BU in this population, cognitively debrief the Urgency NRS, and explore score interpretation and CD remission. A quantitative web survey study was conducted to explore the measurement properties of the urgency NRS.

Results

Qualitative Interview: 34 of 35 participants reported BU. It was most bothersome for 44%, 47% reported it daily, 18% with every bowel movement. BU had a severe impact on daily activities, causing many participants to stay home more than preferred. Patients confirmed the relevance, appropriateness, comprehensibility of the item, recall period, response options, and instructions of the Urgency NRS. Small reductions on the Urgency NRS score reflected meaningful improvements. Quantitative survey: The study sample comprised 76 participants (65.8% female). Mean Urgency NRS score was 4.7 (SD 2.26; N = 76) at Week 1, with no floor/ceiling effect. Test–retest reliability was acceptable. Construct and known-groups validity against selected PROs were overall strong and within ranges hypothesized a priori.

Conclusion

The Urgency NRS is a valid and reliable instrument to assess BU severity in CD.
Appendix
Available only for authorised users
Literature
1.
Kalla, R., Ventham, N. T., Satsangi, J., & Arnott, I. D. (2014). Crohn’s disease. The BMJ, 349, g6670.CrossRefPubMed
2.
3.
Ng, S. C., Shi, H. Y., Hamidi, N., Underwood, F. E., Tang, W., Benchimol, E. I., Panaccione, R., Ghosh, S., Wu, J. C. Y., Chan, F. K. L., Sung, J. J. Y., & Kaplan, G. G. (2017). Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: A systematic review of population-based studies. Lancet, 390(10114), 2769–2778.CrossRefPubMed
4.
Molodecky, N. A., Soon, I. S., Rabi, D. M., Ghali, W. A., Ferris, M., Chernoff, G., Benchimol, E. I., Panaccione, R., Ghosh, S., Barkema, H. W., & Kaplan, G. G. (2012). Increasing incidence and prevalence of the inflammatory Bowel diseases with time, based on systematic review. Gastroenterology, 142(1), 46-54.e42. quiz e30.CrossRefPubMed
5.
Nobrega, V. G., Silva, I. N. N., Brito, B. S., Silva, J., Silva, M., & Santana, G. O. (2018). The Onset of Clinical Manifestations in Inflammatory Bowel Disease Patients. Arquivos de Gastroenterologia, 55(3), 290–295.CrossRefPubMed
6.
Dulai, P. S., Jairath, V., Khanna, R., Ma, C., McCarrier, K. P., Martin, M. L., Parker, C. E., Morris, J., Feagan, B. G., & Sandborn, W. J. (2020). Development of the symptoms and impacts questionnaire for Crohn’s disease and ulcerative colitis. Alimentary Pharmacology & Therapeutics, 51(11), 1047–1066.CrossRef
7.
Petryszyn, P. W., & Paradowski, L. (2018). Stool patterns and symptoms of disordered anorectal function in patients with inflammatory Bowel diseases. Advances in Clinical and Experimental Medicine, 27(6), 813–818.CrossRefPubMed
8.
Casellas, F., Herrera-de Guise, C., Robles, V., Navarro, E., & Borruel, N. (2017). Patient preferences for inflammatory Bowel disease treatment objectives. Digestive and Liver Disease, 49(2), 152–156.CrossRefPubMed
9.
Higgins, P. D. R., Harding, G., Leidy, N. K., DeBusk, K., Patrick, D. L., Viswanathan, H. N., Fitzgerald, K., Donelson, S. M., Cyrille, M., Ortmeier, B. G., Wilson, H., Revicki, D. A., & Globe, G. (2017). Development and validation of the Crohn’s disease patient-reported outcomes signs and symptoms (CD-PRO/SS) diary. Journal of Patient Reported Outcomes, 2(1), 24.CrossRefPubMed
10.
van Deen, W. K., Kiaei, B., Weaver, S. A., Crate, D. J., Kwon, M. H., Shah, S. A., Melmed, G. Y., & Siegel, C. A. (2020). A qualitative inquiry into patients’ perspectives on individualized priorities for treatment outcomes in inflammatory bowel diseases. Quality of Life Research, 29(9), 2403–2414.CrossRefPubMed
11.
Norton, C., Dibley, L. B., & Bassett, P. (2013). Faecal incontinence in inflammatory bowel disease: Associations and effect on quality of life. Journal of Crohn’s and Colitis, 7(8), e302-311.CrossRefPubMed
12.
Rubin, D. T., Sninsky, C., Siegmund, B., Sans, M., Hart, A., Bressler, B., Bouhnik, Y., Armuzzi, A., & Afzali, A. (2021). International perspectives on management of inflammatory Bowel Disease: Opinion differences and similarities between patients and physicians from the IBD GAPPS Survey. Inflammatory Bowel Diseases, 27(12), 1942–1953.CrossRefPubMedPubMedCentral
13.
Louis, E., Ramos-Goñi, J. M., Cuervo, J., Kopylov, U., Barreiro-de Acosta, M., McCartney, S., Rosenfeld, G., Bettenworth, D., Hart, A., Novak, K., Donnet, X., Easton, D., Saldaña, R., Protze, K., Tzur, E., Alperovich, G., & Casellas, F. (2020). A Qualitative Research for Defining Meaningful Attributes for the Treatment of Inflammatory Bowel Disease from the Patient Perspective. The Patient - Patient-Centered Outcomes Research, 13(3), 317–325.CrossRefPubMed
14.
15.
Buchmann, P., Kolb, E., & Alexander-Williams, J. (1981). Pathogenesis of urgency in defaecation in Crohn’s disease. Digestion, 22(6), 310–316.CrossRefPubMed
16.
Dawwas, G. K., Jajeh, H., Shan, M., Naegeli, A. N., Hunter, T., & Lewis, J. D. (2021). Prevalence and factors associated with fecal urgency among patients with ulcerative colitis and Crohn’s disease in the study of a prospective adult research cohort with inflammatory bowel disease. Crohn’s & Colitis 360. https://​doi.​org/​10.​1093/​crocol/​otab046CrossRef
17.
18.
Dubinsky, M. C., Naegeli, A., Dong, Y., Lissoos, T., Arora, V., & Irving, P. (2020). The urgency numeric rating scale (NRS): A novel patient-reported outcome measure to assess bowel urgency in adult patients with ulcerative colitis. Journal of Crohn’s and Colitis, 14, S200–S200.CrossRef
19.
Lichtenstein, G. R., Loftus, E. V., Isaacs, K. L., Regueiro, M. D., Gerson, L. B., & Sands, B. E. (2018). ACG clinical guideline: Management of Crohn’s disease in adults. American Journal of Gastroenterology, 113(4), 481–517.CrossRefPubMed
20.
Guest, G., Bunce, A., & Johnson, L. (2006). How Many Interviews Are Enough?: An Experiment with Data Saturation and Variability. Field Methods, 18(1), 59–82.CrossRef
21.
Hennink, M. M., Kaiser, B. N., & Marconi, V. C. (2017). Code saturation versus meaning saturation: How many interviews are enough? Qualitative Health Research, 27(4), 591–608.CrossRefPubMed
22.
Friese, S., & Ringmayr, T. (2013). ATLAS.ti 7 User Guide and Reference. Berlin: ATLAS.ti Scientific Software Development GmBH.
23.
Leidy, N. K., & Vernon, M. (2008). Perspectives on patient-reported outcomes. Pharmacoeconomics, 26(5), 363–370.CrossRefPubMed
24.
United States Food and Drug Administration. (2009). Guidance for industry on patient-reported outcome measures: use in medical product development to support labeling claims. Federal Register, 74(2355).
25.
Webster, K., Cella, D., & Yost, K. (2003). The functional assessment of chronic illness therapy (FACIT) measurement system: Properties, applications, and interpretation. Health and Quality of Life Outcomes, 1, 79.CrossRefPubMedPubMedCentral
26.
Targum, S. D., Hassman, H., Pinho, M., & Fava, M. (2012). Development of a clinical global impression scale for fatigue. Journal of Psychiatric Research, 46(3), 370–374.CrossRefPubMed
27.
Hays, R. D., & Revicki, D. A. (2005). Reliability and validity, including responsiveness. In P. M. Fayers & R. D. Hays (Eds.), Assessing Quality of Life in Clinical Trials (2nd ed., pp. 25–39). Oxford University Press.CrossRef
28.
Aaronson, N., Alonso, J., Burnam, A., Lohr, K. N., Patrick, D. L., Perrin, E., & Stein, R. E. (2002). Assessing health status and quality-of-life instruments: Attributes and review criteria. Quality of Life Research, 11(3), 193–205.CrossRefPubMed
29.
Bujang, M. A., & Baharum, N. (2017). A simplified guide to determination of sample size requirements for estimating the value of intraclass correlation coefficient: A review. Archives of Orofacial Science, 12(1), 1–11.
30.
Hinkle, D. E., Wiersma, W., & Jurs, S. G. (1988). Applied Statistics for the Behavioral Sciences (2nd ed.). Houghton Mifflin.
31.
Cohen, J. (1988). Statistical power analysis for the behavioral sciences (Revised ed.). Lawrence Earlbaum Associates: Inc.
32.
Nunnally, J. C., & Bernstein, I. (1994). Psychometric theory 3E. Tata McGraw-hill education.
33.
Surti, B., Spiegel, B., Ippoliti, A., Vasiliauskas, E. A., Simpson, P., Shih, D. Q., Targan, S. R., McGovern, D. P., & Melmed, G. Y. (2013). Assessing health status in inflammatory bowel disease using a novel single-item numeric rating scale. Digestive Diseases and Sciences, 58(5), 1313–1321.CrossRefPubMed
34.
Dubinsky, M. C., Delbecque, L., Lewis, J., Hunter, T., & Shan, M. (2022). Psychometric validation and interpretation of a patient-reported outcomes instrument to assess bowel urgency among adults with moderate to severe Ulcerative Colitis. Journal of Crohn’s and Colitis, 16, P138.CrossRef
35.
Dibley, L., Khoshaba, B., Artom, M., Van Loo, V., Sweeney, L., Syred, J., Windgassen, S., Moffatt, G., & Norton, C. (2021). Patient strategies for managing the vicious cycle of fatigue, pain and urgency in inflammatory bowel disease: Impact, planning and support. Digestive Diseases and Sciences, 66(10), 3330–3342.CrossRefPubMed
36.
Smith, B. (2018). Generalizability in qualitative research: Misunderstandings, opportunities and recommendations for the sport and exercise sciences. Qualitative Research in Sport, Exercise and Health, 10(1), 137–149.CrossRef
Metadata
Title
Validation of the bowel urgency numeric rating scale in patients with Crohn’s disease: results from a mixed methods study
Authors
Marla C. Dubinsky
Laure Delbecque
Theresa Hunter
Gale Harding
Larissa Stassek
Richard E. Moses
James D. Lewis
Publication date
04-08-2023
Publisher
Springer International Publishing
Published in
Quality of Life Research / Issue 12/2023
Print ISSN: 0962-9343
Electronic ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-023-03494-y

Other articles of this Issue 12/2023

Quality of Life Research 12/2023 Go to the issue

OriginalPaper

Supportive care needs in Australian melanoma patients and caregivers: results from a quantitative cross-sectional survey

OriginalPaper

Association of body mass index from childhood to mid-adulthood with health-related quality of life in mid-adulthood

OriginalPaper

Estimating the disutility of relapse in relapsing–remitting and secondary progressive multiple sclerosis using the EQ-5D-5L, AQoL-8D, EQ-5D-5L-psychosocial, and SF-6D: implications for health economic evaluation models

OriginalPaper

Development and initial psychometric evaluation of a COVID-related psychosocial experiences questionnaire for cancer survivors

OriginalPaper

Living well while providing support: validation of LTCQ-Carer for assessing informal carers’ quality of life

OriginalPaper

Change in health-related quality of life and functional disability over time post-concussion in youth