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Reliability among central readers in the evaluation of endoscopic findings from patients with Crohn's disease
  1. Reena Khanna1,2,
  2. Guangyong Zou1,3,
  3. Geert D'Haens1,4,
  4. Paul Rutgeerts5,
  5. J W D McDonald1,
  6. Marco Daperno6,
  7. Brian G Feagan1,2,3,
  8. William J Sandborn1,7,
  9. Elena Dubcenco1,
  10. Larry Stitt1,
  11. Margaret K Vandervoort1,
  12. Allan Donner1,
  13. Allison Luo8,
  14. Barrett G Levesque1,7
  1. 1Robarts Clinical Trials, Robarts Research Institute, University of Western Ontario, London, Ontario, Canada
  2. 2Department of Medicine, University of Western Ontario, London, Ontario, Canada
  3. 3Department of Epidemiology and Biostatistics, University of Western Ontario, London, Ontario, Canada
  4. 4Inflammatory Bowel Disease Centre, Academic Medical Centre, Amsterdam, The Netherlands
  5. 5Department of Gastroenterology, University Hospital, Gasthuisberg, Leuven, Belgium
  6. 6Gastroenterology Division, A.O. Ordine Mauriziano, Torino, Italy
  7. 7Division of Gastroenterology, University of California San Diego, La Jolla, California, USA
  8. 8Bristol-Myers Squibb, Princeton, New Jersey, USA
  1. Correspondence to Dr Brian G Feagan, Robarts Clinical Trials, Departments of Medicine, Epidemiology and Biostatistics, University of Western Ontario, London, Ontario, Canada N6A 5K8; brian.feagan{at}robartsinc.com

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.

  • INFLAMMATORY BOWEL DISEASE
  • ENDOSCOPY

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