Development and validation of the Ulcerative Colitis patient-reported outcomes signs and symptoms (UC-pro/SS) diary
dc.contributor.author | Higgins, Peter D R | |
dc.contributor.author | Harding, Gale | |
dc.contributor.author | Revicki, Dennis A | |
dc.contributor.author | Globe, Gary | |
dc.contributor.author | Patrick, Donald L | |
dc.contributor.author | Fitzgerald, Kristina | |
dc.contributor.author | Viswanathan, Hema | |
dc.contributor.author | Donelson, Sarah M | |
dc.contributor.author | Ortmeier, Brian G | |
dc.contributor.author | Chen, Wen H | |
dc.contributor.author | Leidy, Nancy K | |
dc.contributor.author | DeBusk, Kendra | |
dc.date.accessioned | 2018-06-03T04:01:21Z | |
dc.date.available | 2018-06-03T04:01:21Z | |
dc.date.issued | 2018-05-30 | |
dc.identifier.citation | Journal of Patient-Reported Outcomes. 2018 May 30;2(1):26 | |
dc.identifier.uri | https://doi.org/10.1186/s41687-018-0049-2 | |
dc.identifier.uri | https://hdl.handle.net/2027.42/143869 | |
dc.description.abstract | Abstract Background The clinical course of ulcerative colitis (UC) and the effects of treatment are assessed through patient-reported signs and symptoms (S&S), and endoscopic evidence of inflammation. The Ulcerative Colitis Patient-Reported Outcomes Signs and Symptoms (UC-PRO/SS) measure was developed to standardize the quantification of gastrointestinal S&S of UC in clinical trials through direct report from patient ratings. Design The UC-PRO/SS was developed by collecting data from concept elicitation (focus groups, and individual interviews), then refined through a process of cognitive interviews of 57 UC patients. Measurement properties, including item-level statistics, scaling structure, reliability, and validity, were evaluated in an observational, four-week study of adults with mild to severe UC (N = 200). Results Findings from qualitative focus groups and interviews identified nine symptom items covering bowel and abdominal symptoms. The final UC-PRO/SS daily diary includes two scales: Bowel S&S (six items) and Abdominal Symptoms (three items), each scored separately. Each scale showed evidence of adequate reliability (α = 80 and 0.66, respectively); reproducibility (intraclass correlation coefficient = 0.81, 0.71) and validity, including moderate-to-high correlations with the Partial Mayo Score (0.79; 0.45) and Inflammatory Bowel Disease Questionnaire (IBDQ) total score (− 0.70; − 0.61). Scores discriminated by level of disease severity, as defined by the Partial Mayo Score, Patient Global Rating, and Clinician Global Rating (p < 0.0001). Conclusions Results suggest that the UC-PRO/SS is a reliable and valid measure of gastrointestinal symptom severity in UC patients. Additional longitudinal data are needed to evaluate the ability of the UC-PRO/SS scores to detect responsiveness and inform the selection of responder definitions. | |
dc.title | Development and validation of the Ulcerative Colitis patient-reported outcomes signs and symptoms (UC-pro/SS) diary | |
dc.type | Article | en_US |
dc.description.bitstreamurl | https://deepblue.lib.umich.edu/bitstream/2027.42/143869/1/41687_2018_Article_49.pdf | |
dc.language.rfc3066 | en | |
dc.rights.holder | The Author(s) | |
dc.date.updated | 2018-06-03T04:01:22Z | |
dc.owningcollname | Interdisciplinary and Peer-Reviewed |
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