Reena Khanna1, Guangyong Zou2, Geert D'Haens3, Paul Rutgeerts4, J W D McDonald5, Marco Daperno6, Brian G Feagan7, William J Sandborn8, Elena Dubcenco5, Larry Stitt5, Margaret K Vandervoort5, Allan Donner5, Allison Luo9, Barrett G Levesque8. 1. Robarts Clinical Trials, Robarts Research Institute, University of Western Ontario, London, Ontario, Canada Department of Medicine, University of Western Ontario, London, Ontario, Canada. 2. Robarts Clinical Trials, Robarts Research Institute, University of Western Ontario, London, Ontario, Canada Department of Epidemiology and Biostatistics, University of Western Ontario, London, Ontario, Canada. 3. Robarts Clinical Trials, Robarts Research Institute, University of Western Ontario, London, Ontario, Canada Inflammatory Bowel Disease Centre, Academic Medical Centre, Amsterdam, The Netherlands. 4. Department of Gastroenterology, University Hospital, Gasthuisberg, Leuven, Belgium. 5. Robarts Clinical Trials, Robarts Research Institute, University of Western Ontario, London, Ontario, Canada. 6. Gastroenterology Division, A.O. Ordine Mauriziano, Torino, Italy. 7. Robarts Clinical Trials, Robarts Research Institute, University of Western Ontario, London, Ontario, Canada Department of Medicine, University of Western Ontario, London, Ontario, Canada Department of Epidemiology and Biostatistics, University of Western Ontario, London, Ontario, Canada. 8. Robarts Clinical Trials, Robarts Research Institute, University of Western Ontario, London, Ontario, Canada Division of Gastroenterology, University of California San Diego, La Jolla, California, USA. 9. Bristol-Myers Squibb, Princeton, New Jersey, USA.
Abstract
OBJECTIVE: The Crohn's Disease Endoscopic Index of Severity (CDEIS) and Simple Endoscopic Score for Crohn's Disease (SES-CD) are commonly used to assess Crohn's disease (CD) activity; however, neither instrument has been fully validated. We assessed intra-rater and inter-rater reliability of these indices. DESIGN: Video recordings of colonoscopies obtained from 50 patients with CD who participated in an induction trial of a biological therapy were triplicated and reviewed in random order by four central readers. Data were used to assess intra-rater and inter-rater reliability for CDEIS, SES-CD and a global evaluation of lesion severity (GELS). Subsequently, readers participated in a consensus process that identified common sources of disagreement. RESULTS:Intraclass correlation coefficients (ICCs) for intra-rater reliability for CDEIS, SES-CD and GELS (95% CIs) were 0.89 (0.86 to 0.93), 0.91 (0.89 to 0.95) and 0.81 (0.77 to 0.89), respectively, with standard error of measurement (SEM) of 2.10, 2.42 and 1.15. The corresponding ICCs for inter-rater reliability were 0.71 (0.63 to 0.76), 0.83 (0.75 to 0.88) and 0.62 (0.52 to 0.70), with SEM of 3.42, 3.07 and 1.63, respectively. Correlation between CDEIS and GELS was 0.75, between SES-CD and GELS was 0.74 and between CDEIS and SES-CD was 0.92. The most common sources of disagreement were interpretation of superficial ulceration, definition of disease site at the ileocolonic anastomosis, assessment of anorectal lesions and grading severity of stenosis. CONCLUSIONS: Central reading of CDEIS and SES-CD had 'substantial' to 'almost perfect' intra-rater and inter-rater reliability; however, the responsiveness of these instruments is yet to be determined. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov NCT01466374. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
RCT Entities:
OBJECTIVE: The Crohn's Disease Endoscopic Index of Severity (CDEIS) and Simple Endoscopic Score for Crohn's Disease (SES-CD) are commonly used to assess Crohn's disease (CD) activity; however, neither instrument has been fully validated. We assessed intra-rater and inter-rater reliability of these indices. DESIGN: Video recordings of colonoscopies obtained from 50 patients with CD who participated in an induction trial of a biological therapy were triplicated and reviewed in random order by four central readers. Data were used to assess intra-rater and inter-rater reliability for CDEIS, SES-CD and a global evaluation of lesion severity (GELS). Subsequently, readers participated in a consensus process that identified common sources of disagreement. RESULTS: Intraclass correlation coefficients (ICCs) for intra-rater reliability for CDEIS, SES-CD and GELS (95% CIs) were 0.89 (0.86 to 0.93), 0.91 (0.89 to 0.95) and 0.81 (0.77 to 0.89), respectively, with standard error of measurement (SEM) of 2.10, 2.42 and 1.15. The corresponding ICCs for inter-rater reliability were 0.71 (0.63 to 0.76), 0.83 (0.75 to 0.88) and 0.62 (0.52 to 0.70), with SEM of 3.42, 3.07 and 1.63, respectively. Correlation between CDEIS and GELS was 0.75, between SES-CD and GELS was 0.74 and between CDEIS and SES-CD was 0.92. The most common sources of disagreement were interpretation of superficial ulceration, definition of disease site at the ileocolonic anastomosis, assessment of anorectal lesions and grading severity of stenosis. CONCLUSIONS: Central reading of CDEIS and SES-CD had 'substantial' to 'almost perfect' intra-rater and inter-rater reliability; however, the responsiveness of these instruments is yet to be determined. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov NCT01466374. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
Authors: Reena Khanna; GuangYong Zou; Larry Stitt; Brian G Feagan; William J Sandborn; Paul Rutgeerts; John W D McDonald; Elena Dubcenco; Ronald Fogel; Remo Panaccione; Vipul Jairath; Sigrid Nelson; Lisa M Shackelton; Bidan Huang; Qian Zhou; Anne M Robinson; Barrett G Levesque; Geert D'Haens Journal: Am J Gastroenterol Date: 2017-01-10 Impact factor: 10.864
Authors: Reena Khanna; Sigrid A Nelson; Brian G Feagan; Geert D'Haens; William J Sandborn; G Y Zou; John K MacDonald; Claire E Parker; Vipul Jairath; Barrett G Levesque Journal: Cochrane Database Syst Rev Date: 2016-08-08
Authors: L Peyrin-Biroulet; W Sandborn; B E Sands; W Reinisch; W Bemelman; R V Bryant; G D'Haens; I Dotan; M Dubinsky; B Feagan; G Fiorino; R Gearry; S Krishnareddy; P L Lakatos; E V Loftus; P Marteau; P Munkholm; T B Murdoch; I Ordás; R Panaccione; R H Riddell; J Ruel; D T Rubin; M Samaan; C A Siegel; M S Silverberg; J Stoker; S Schreiber; S Travis; G Van Assche; S Danese; J Panes; G Bouguen; S O'Donnell; B Pariente; S Winer; S Hanauer; J-F Colombel Journal: Am J Gastroenterol Date: 2015-08-25 Impact factor: 10.864
Authors: Gary R Lichtenstein; Edward V Loftus; Kim L Isaacs; Miguel D Regueiro; Lauren B Gerson; Bruce E Sands Journal: Am J Gastroenterol Date: 2018-03-27 Impact factor: 10.864
Authors: Calen A Steiner; Jeffrey A Berinstein; Jeremy Louissaint; Peter D R Higgins; Jason R Spence; Carol Shannon; Cathy Lu; Ryan W Stidham; Joel G Fletcher; David H Bruining; Brian G Feagan; Vipul Jairath; Mark E Baker; Dominik Bettenworth; Florian Rieder Journal: Clin Gastroenterol Hepatol Date: 2021-06-02 Impact factor: 11.382