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.
<p><strong>Background:</strong> 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 tr...
| Main Authors: | , , , , , , , |
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| Format: | Journal article |
| Language: | English |
| Published: |
Springer
2022
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| _version_ | 1797110491754004480 |
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| author | Dubinsky, MC Irving, PM Panaccione, R Naegeli, AN Potts-Bleakman, A Arora, V Shan, M Travis, S |
| author_facet | Dubinsky, MC Irving, PM Panaccione, R Naegeli, AN Potts-Bleakman, A Arora, V Shan, M Travis, S |
| author_sort | Dubinsky, MC |
| collection | OXFORD |
| description | <p><strong>Background:</strong> 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.</p>
<p><strong>Methods:</strong> 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.</p>
<p><strong>Results:</strong> 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.</p>
<p><strong>Conclusions:</strong> 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.</p> |
| first_indexed | 2024-03-07T07:55:35Z |
| format | Journal article |
| id | oxford-uuid:281069e1-55de-48fc-9160-352a362112d3 |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-07T07:55:35Z |
| publishDate | 2022 |
| publisher | Springer |
| record_format | dspace |
| spelling | oxford-uuid:281069e1-55de-48fc-9160-352a362112d32023-08-18T14:49:02ZIncorporating 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.Journal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:281069e1-55de-48fc-9160-352a362112d3EnglishSymplectic ElementsSpringer2022Dubinsky, MCIrving, PMPanaccione, RNaegeli, ANPotts-Bleakman, AArora, VShan, MTravis, S<p><strong>Background:</strong> 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.</p> <p><strong>Methods:</strong> 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.</p> <p><strong>Results:</strong> 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.</p> <p><strong>Conclusions:</strong> 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.</p> |
| spellingShingle | Dubinsky, MC Irving, PM Panaccione, R Naegeli, AN Potts-Bleakman, A Arora, V Shan, M Travis, S 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. |
| title | 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. |
| title_full | 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. |
| title_fullStr | 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. |
| title_full_unstemmed | 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. |
| title_short | 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. |
| title_sort | 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 |
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