Development and validation of the Crohn's disease patient-reported outcomes signs and symptoms (CD-PRO/SS) diary.

Autor:	Higgins, Peter D. R., Harding, Gale, Leidy, Nancy K., DeBusk, Kendra, Patrick, Donald L., Viswanathan, Hema N., Fitzgerald, Kristina, Donelson, Sarah M., Cyrille, Marcoli, Ortmeier, Brian G., Wilson, Hilary, Revicki, Dennis A., Globe, Gary
Předmět:	CROHN'S disease INFLAMMATION GASTROINTESTINAL agents CLINICAL trials INFLAMMATORY bowel diseases EXPERIMENTAL design STATISTICS RESEARCH evaluation STATISTICAL reliability RESEARCH methodology RESEARCH methodology evaluation HEALTH outcome assessment INTERVIEWING QUALITATIVE research MULTITRAIT multimethod techniques CRONBACH'S alpha DESCRIPTIVE statistics INTRACLASS correlation QUESTIONNAIRES RESEARCH funding DATA analysis software DATA analysis SECONDARY analysis SYMPTOMS
Zdroj:	Journal of Patient-Reported Outcomes; 12/1/2018, Vol. 2 Issue 1, pN.PAG-N.PAG, 1p
Abstrakt:	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. [ABSTRACT FROM AUTHOR]
Databáze:	Complementary Index
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