Reliability among central readers in the evaluation of endoscopic findings from patients with Crohn's disease.
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.



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.



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.



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.



Clinicaltrials.gov NCT01466374.
Robarts Clinical Trials, Robarts Research Institute, University of Western Ontario, London, Ontario, Canada Department of Medicine, University of Western Ontario, London, Ontario, Canada.
Reena
R
Khanna
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.
Guangyong
G
Zou
Robarts Clinical Trials, Robarts Research Institute, University of Western Ontario, London, Ontario, Canada Inflammatory Bowel Disease Centre, Academic Medical Centre, Amsterdam, The Netherlands.
Geert
G
D'Haens
Department of Gastroenterology, University Hospital, Gasthuisberg, Leuven, Belgium.
Paul
P
Rutgeerts
Robarts Clinical Trials, Robarts Research Institute, University of Western Ontario, London, Ontario, Canada.
J W D
JW
McDonald
Gastroenterology Division, A.O. Ordine Mauriziano, Torino, Italy.
Marco
M
Daperno
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.
Brian G
BG
Feagan
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.
William J
WJ
Sandborn
Robarts Clinical Trials, Robarts Research Institute, University of Western Ontario, London, Ontario, Canada.
Elena
E
Dubcenco
Robarts Clinical Trials, Robarts Research Institute, University of Western Ontario, London, Ontario, Canada.
Larry
L
Stitt
Robarts Clinical Trials, Robarts Research Institute, University of Western Ontario, London, Ontario, Canada.
Margaret K
MK
Vandervoort
Robarts Clinical Trials, Robarts Research Institute, University of Western Ontario, London, Ontario, Canada.
Allan
A
Donner
Bristol-Myers Squibb, Princeton, New Jersey, USA.
Allison
A
Luo
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.
Barrett G
BG
Levesque
D000328:Adult; D032921:Consensus; D003251:Constriction, Pathologic / Q000000981:diagnostic imaging / Q000209:etiology; D003424:Crohn Disease / Q000150:complications / Q000000981:diagnostic imaging* / Q000188:drug therapy; D016099:Endoscopy, Gastrointestinal; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015588:Observer Variation; D015203:Reproducibility of Results; D012720:Severity of Illness Index; D014456:Ulcer / Q000000981:diagnostic imaging / Q000209:etiology; D014741:Video Recording; D055815:Young Adult
ENDOSCOPY; INFLAMMATORY BOWEL DISEASE