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

Journal of Patient-reported Outcomes
Peter D R HigginsGary Globe

Abstract

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. 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). 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 ...Continue Reading

References

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Citations

Apr 19, 2020·Current Opinion in Gastroenterology·Edward L Barnes
Nov 22, 2019·World Journal of Gastroenterology : WJG·Lorant GoncziPeter Laszlo Lakatos
May 24, 2020·Advances in Therapy·William J SandbornUNKNOWN Etrolizumab Global Steering Committee
Apr 23, 2020·Alimentary Pharmacology & Therapeutics·Parambir S DulaiWilliam J Sandborn
Feb 19, 2020·Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association·Lukasz KwapiszEdward V Loftus
Mar 28, 2020·United European Gastroenterology Journal
Apr 18, 2021·Gastroenterology·Marla C DubinskyUNKNOWN International Organization for the Study of Inflammatory Bowel Diseases (IOIBD)
Aug 31, 2021·Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association·Jeffrey A BerinsteinPeter D R Higgins

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Methods Mentioned

BETA
biopsy

Software Mentioned

PRO
RUMM2030
EuroQol
SAS
CD
ti
NVivo
Mplus
ATLAS

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