Development and validation of the Crohn’s disease patient-reported outcomes signs and symptoms (CD-PRO/SS) diary
dc.contributor.author | Higgins, Peter D R | |
dc.contributor.author | Harding, Gale | |
dc.contributor.author | Leidy, Nancy K | |
dc.contributor.author | DeBusk, Kendra | |
dc.contributor.author | Patrick, Donald L | |
dc.contributor.author | Viswanathan, Hema N | |
dc.contributor.author | Fitzgerald, Kristina | |
dc.contributor.author | Donelson, Sarah M | |
dc.contributor.author | Cyrille, Marcoli | |
dc.contributor.author | Ortmeier, Brian G | |
dc.contributor.author | Wilson, Hilary | |
dc.contributor.author | Revicki, Dennis A | |
dc.contributor.author | Globe, Gary | |
dc.date.accessioned | 2018-05-13T03:29:46Z | |
dc.date.available | 2018-05-13T03:29:46Z | |
dc.date.issued | 2018-05-09 | |
dc.identifier.citation | Journal of Patient-Reported Outcomes. 2018 May 09;2(1):24 | |
dc.identifier.uri | https://doi.org/10.1186/s41687-018-0044-7 | |
dc.identifier.uri | https://hdl.handle.net/2027.42/143542 | |
dc.description.abstract | Abstract Background The clinical course of Crohn’s disease (CD) and the effect of its treatment are monitored through patient-reported signs and symptoms (S&S), and endoscopic evidence of inflammation. The Crohn’s Disease Patient-reported Outcomes Signs and Symptoms (CD-PRO/SS) measure was developed to standardize the quantification of gastrointestinal S&S of CD through direct report from patient ratings. Methods The CD-PRO/SS was developed based on data from concept elicitation (focus groups, interviews; n = 29), then refined through cognitive interviews of CD patients (n = 20). Measurement properties, including item-level statistics, scaling structure, reliability, and validity, were examined using secondary analyses of baseline and two-week clinical trial data of adults with moderate-to-severe CD (n = 238). Results Findings from qualitative interviews identified nine S&S items covering bowel and abdominal symptoms. The final CD-PRO/SS daily diary includes two scales: Bowel S&S (three items) and Abdominal Symptoms (three items), each scored separately. Each scale showed evidence of adequate reliability (α = 0.74 and 0.67, respectively); reproducibility (intraclass correlation coefficient > 0.80), and validity, with the last including moderate correlations with the Inflammatory Bowel Disease Questionnaire bowel symptom score and select items (ranging from r = 0.43–0.54). Scores distinguished patients categorized by patient global ratings of disease severity (p < 0.0001). Conclusions Results suggest the CD-PRO/SS is a reliable and valid measure of gastrointestinal symptom severity in CD patients. Additional longitudinal data are needed to evaluate the ability of the CD-PRO/SS scores to detect responsiveness and inform the selection of responder definitions. | |
dc.title | Development and validation of the Crohn’s disease patient-reported outcomes signs and symptoms (CD-PRO/SS) diary | |
dc.type | Article | en_US |
dc.description.bitstreamurl | https://deepblue.lib.umich.edu/bitstream/2027.42/143542/1/41687_2018_Article_44.pdf | |
dc.language.rfc3066 | en | |
dc.rights.holder | The Author(s) | |
dc.date.updated | 2018-05-13T03:29:47Z | |
dc.owningcollname | Interdisciplinary and Peer-Reviewed |
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