Development and validation of the Crohn’s disease patient-reported outcomes signs and symptoms (CD-PRO/SS) diary
| Autor: | Hema N. Viswanathan, Donald L. Patrick, Gale Harding, Sarah Donelson, Dennis A. Revicki, Nancy Kline Leidy, Kristina Fitzgerald, Kendra DeBusk, Peter D.R. Higgins, Marcoli Cyrille, Brian G. Ortmeier, Hilary Wilson |
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| Rok vydání: | 2018 |
| Předmět: |
Crohn’s disease
medicine.medical_specialty Intraclass correlation Health Informatics Signs and symptoms Disease Inflammatory bowel disease Validity 03 medical and health sciences 0302 clinical medicine Health Information Management Internal medicine medicine Patient-reported outcome Crohn's disease business.industry lcsh:Public aspects of medicine Research Clinical course lcsh:RA1-1270 Reliability medicine.disease Clinical trial endpoints Clinical trial 030220 oncology & carcinogenesis 030211 gastroenterology & hepatology business |
| Zdroj: | Journal of Patient-Reported Outcomes Journal of Patient-Reported Outcomes, Vol 2, Iss 1, Pp 1-10 (2018) |
| ISSN: | 2509-8020 |
| DOI: | 10.1186/s41687-018-0044-7 |
| Popis: | 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 |
| Databáze: | OpenAIRE |
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